[Federal Register: November 7, 2003 (Volume 68, Number 216)]
[Rules and Regulations]               
[Page 63195-63395]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no03-11]                         
 

[[Page 63195]]

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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 410 and 414



Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule for Calendar Year 2004; Final Rule


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410 and 414

[CMS-1476-FC]
RIN 0938-AL96

 
Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule for Calendar Year 2004

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule will refine the resource-based practice 
expense relative value units (RVUs) and make other changes to Medicare 
Part B payment policy. The policy changes concern: Medicare Economic 
Index, practice expense for professional component services, definition 
of diabetes for diabetes self-management training, supplemental survey 
data for practice expense, geographic practice cost indices, and 
several coding issues. In addition, this rule updates the codes subject 
to the physician self-referral prohibition. We also make revisions to 
the sustainable growth rate and the anesthesia conversion factor.
    These changes will ensure that our payment systems are updated to 
reflect changes in medical practice and the relative value of services.
    We are also finalizing the calendar year (CY) 2003 interim RVUs and 
are issuing interim RVUs for new and revised procedure codes for CY 
2004.
    As required by the statute, we are announcing that the physician 
fee schedule update for CY 2004 is -4.5 percent, the initial estimate 
of the sustainable growth rate for CY 2004 is 7.4 percent, and the 
conversion factor for CY 2004 is $35.1339.
    We published a proposed rule (68 FR 50428) in the Federal Register 
on Part B drug payment reform on August 20, 2003. This proposed rule 
would also make changes to Medicare payment for furnishing or 
administering certain drugs and biologicals. We have not finalized 
these proposals to take into account that the Congress is considering 
legislation that would address these issues. We will continue to 
monitor legislative activity that would reform the Medicare Part B drug 
payment system. If legislation is not enacted soon on this issue, we 
remain committed to completing the regulatory process.

DATES: Effective date: These regulations are effective on January 1, 
2004.
    Comment date: We will consider comments on the physician self-
referral designated health services additions and deletions identified 
in Tables 8 and 9, and the interim work RVUs for selected procedure 
codes identified in Addendum C if we receive them at the appropriate 
address, as provided in the addresses section, no later than 5 p.m. on 
January 6, 2004.

ADDRESSES: In commenting, please refer to file code CMS-1476-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (one original and 
two copies) to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1476-FC, P.O. Box 8013, Baltimore, MD 
21244-8013.
    Please allow sufficient time for us to receive mailed comments on 
time in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and two copies) to one of the following 
addresses:
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or Room C5-14-03, 7500 Security Boulevard, 
Baltimore, MD 21244-8013.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available if you wish to retain proof of filing by stamping in and 
retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Pam West (410) 786-2302 (for issues related to practice expense.)
    Jim Menas (410) 786-4507 (for issues related to anesthesia.)
    Rick Ensor (410) 786-5617 (for issues related to Geographic Cost 
Price Index (GPCI).)
    Mary Stojak (410) 786-6939 (for issues related to the definition of 
diabetes for diabetes self-management training (DSMT).)
    Shannon Martin (410) 786-7939 (for issues related to rebasing of 
the Medicare Economic Index (MEI).)
    Craig Dobyski, (410) 786-4584 (for issues related to telehealth).
    Joanne Sinsheimer, (410) 786-4620 (for issues related to updates to 
the list of certain services subject to the physician self-referral 
prohibitions).
    Diane Milstead (410) 786-3355, Latesha Walker (410) 786-1101, or 
Gaysha Brooks (410) 786-3355 (for all other issues.)

SUPPLEMENTARY INFORMATION: 
    Copies: To order copies of the Federal Register containing this 
document, send your request to: New Orders, Superintendent of 
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date 
of the issue requested and enclose a check or money order payable to 
the Superintendent of Documents, or enclose your Visa or Master Card 
number and expiration date. Credit card orders can also be placed by 
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $10. As an alternative, you can view 
and photocopy the Federal Register document at most libraries 
designated as Federal Depository Libraries and at many other public and 
academic libraries throughout the country that receive the Federal 
Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO access, a service of the U.S. 
Government Printing Office. The Web site address is http://www.access.gpo.gov/nara/index.html
.

Accessing Physician Fee Schedule Web Site and Pricing Information

    Information on the physician fee schedule and pricing files can be 
found on our homepage. You can access this data by typing the 
following: http://cms.hhs.gov/physicians/pfs or you can access this 
data by using the following directions:
    1. Go to the CMS homepage (http://www.cms.hhs.gov).
    2. Place your cursor over the word ``Professionals'' in the blue 
area near the top of the page. Select ``Physicians'' from the drop-down 
menu.
    3. Scroll down and under ``Payment/Billing'' select ``Physician Fee 
Schedule'.
    The Physician Fee Schedule pricing information is contained in two 
public use files.
    (1) National Physician Fee Schedule Relative Value File--This file 
contains all CPT/HCPCS (excluding codes beginning with B, E, L, K, and 
O), their short descriptions and a status indicator, which denotes 
whether or not the service is priced under the physician fee schedule. 
The file also contains the components used in the calculation of the 
annual pricing amount (that is., the RVUs, GPCIs, and

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conversion factor), anesthesia conversion factors, and the payment 
policy indicators used to price the claims with surgical modifiers. 
This file does not contain the calculated pricing amounts.
    (2) Physician Fee Schedule Payment Amount File National/Carrier--
This file contains the CPT code and the Medicare price for all services 
priced under the Physician Fee Schedule. These data can be downloaded 
for (a) the entire country, or (b) for a selected carrier (in most 
cases carriers correlate with states). There is no option of requesting 
data for selected HCPCS codes. The zip file, which is downloaded, 
contains a file named PF04pc.doc, which explains the data contained in 
each column. This file also contains a description of pricing 
localities used in the Physician Fee Schedule. Due to the size of the 
national file (as well as many of the carrier-specific files), these 
data are provided in a comma-delimited format, which can be used to 
populate database applications. Generally speaking, these data are too 
large for Excel, however if a carrier specific file has 3 or fewer 
localities, Excel can be used.
    Another file that providers may find useful is the Zipcode to 
Carrier Locality File. This file will map ZIP Codes to CMS carriers and 
localities and map Zip Codes to their State and determine whether the 
ZIP Code has a rural designation as determined by CMS. You can access 
this file by typing the following: http://cms.hhs.gov/providers/pufdownload/default.asp#alphanu
 or you can access this data by using 
the following directions:
    1. Go to the CMS homepage (http://www.cms.hhs.gov).
    2. Place your cursor over the word ``Professionals'' in the blue 
area near the top of the page. Select ``Physicians'' from the drop-down 
menu.
    3. Scroll down and under ``Payment/Billing'' select ``Medicare 
Payment Systems.''
    4. Scroll down and under Coding Files select ``Zipcode to Carrier 
Locality File.''

Table of Contents

I. Background
    A. Legislative History
    B. Published Changes to the Fee Schedule
II. Specific Provisions for Calendar Year 2004
    A. Resource-Based Practice Expense Relative Value Units
    1. Resource-Based Practice Expense Legislation
    2. Current Methodology
    3. Practice Expense Proposals for Calendar Year 2004
    B. Geographic Practice Cost Indices (GPCIs)
    C. Coding Issues
III. Other Issues
    A. Definition of Diabetes for Diabetes Self-Management Training 
(DSMT)
    B. Outpatient Therapy Services Performed ``Incident To'' 
Physicians Services
    C. Status of Anesthesia Work and 5-Year Review
    D. Payment Policies for Anesthesia Services
    E. Technical Correction
    F. Publication Issues
IV. Refinement of Relative Value Units for Calendar Year 2004 and 
Response to Public Comments on Interim Relative Value Units for 2003
V. Update to the Codes for Physician Self-Referral Prohibition
VI. Physician Fee Schedule Update for Calendar Year 2004
VII. Allowed Expenditures for Physicians' Services and the 
Sustainable Growth Rate
VIII. Anesthesia and Physician Fee Schedule Conversion Factors for 
CY 2004
IX. Telehealth Originating Site Facility Fee Payment Amount Update
X. Provisions of the Final Rule
XI. Collection of Information Requirements
XII. Response to Comments
XIII. Regulatory Impact Analysis
Addendum A--Explanation and Use of Addendum B
Addendum B--2004 Relative Value Units and Related Information Used 
in Determining Medicare Payments for 2004 Addendum C--Codes with 
Interim RVUs
Addendum D--2004 Geographic Practice Cost Indices by Medicare 
Carrier and Locality
Addendum E--2005 Geographic Practice Cost Indices by Medicare 
Carrier and Locality
Addendum F--Updated List of CPT/HCPCS Codes Used to Describe Certain 
Designated Health Services Under the Physician Self-Referral 
Provision

    In addition, because of the many organizations and terms to which 
we refer by acronym in this proposed rule, we are listing these 
acronyms and their corresponding terms in alphabetical order below:

AMA American Medical Association
APC Ambulatory Payment Classification
BBA Balanced Budget Act of 1997
BBRA Balanced Budget Refinement Act of 1999
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and Protection 
Act of 2000
CF Conversion factor
CFR Code of Federal Regulations
CMS Centers for Medicare & Medicaid Services
CNS Clinical Nurse Specialist
CPT [Physicians'] Current Procedural Terminology [4th Edition, 2002, 
copyrighted by the American Medical Association]
CPEP Clinical Practice Expert Panel
CRNA Certified Registered Nurse Anesthetist
DHHS Department of Health and Human Services
E/M Evaluation and management
ESRD End-Stage Renal Disease
GAF Geographic adjustment factor
GPCI Geographic practice cost index
HCPCS Healthcare Common Procedure Coding System
HHA Home health agency
IDTFs Independent Diagnostic Testing Facilities
MCM Medicare Carrier Manual
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MGMA Medical Group Management Association
MPFS Medicare Physician Fee Schedule
MSA Metropolitan Statistical Area
OMB Office of Management and Budget
PC Professional component
PEAC Practice Expense Advisory Committee
PPO Preferred Provider Organization
PPS Prospective payment system
PRA Paperwork Reduction Act of 1995
RUC [AMA's Specialty Society] Relative [Value] Update Committee
RVU Relative value unit
SGR Sustainable growth rate
SMS [AMA's] Socioeconomic Monitoring System
SNF Skilled Nursing Facility
TC Technical component

I. Background

A. Legislative History

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Social Security Act (the Act), ``Payment for 
Physicians'' Services.'' This section provides for three major 
elements: (1) A fee schedule for the payment of physicians' services; 
(2) limits on the amounts that nonparticipating physicians can charge 
beneficiaries; and (3) a sustainable growth rate (SGR) for the rates of 
increase in Medicare expenditures for physicians' services. The Act 
requires that payments under the fee schedule be based on national 
uniform relative value units (RVUs) that are based on the resources 
used in furnishing a service. Section 1848(c) of the Act requires that 
national RVUs be established for physician work, practice expense, and 
malpractice expense. Section 1848(c)(2)(B)(ii)(II) of the Act provides 
that adjustments in RVUs may not cause total physician fee schedule 
payments to differ by more than $20 million from what they would have 
been had the adjustments not been made. If adjustments to RVUs cause 
expenditures to change by more than

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$20 million, we must make adjustments to ensure that they do not 
increase or decrease by more than $20 million.

B. Published Changes to the Fee Schedule

    In the July 2000 proposed rule, (65 FR 44177), we listed all of the 
final rules published through November 1999. In the August 2001 
proposed rule (66 FR 40372) we discussed the November 2000 final rule 
relating to the updates to the RVUs and revisions to payment policies 
under the physician fee schedule.
    In the November 2001 final rule with comment period (66 FR 55246), 
we made revisions to resource-based practice expense RVUs; services and 
supplies incident to a physician's professional service; anesthesia 
base unit variations; recognition of Physicians' Current Procedural 
Terminology (CPT) tracking codes; and nurse practitioners, physician 
assistants, and clinical nurse specialists performing screening 
sigmoidoscopies. We also addressed comments received on the June 8, 
2001 proposed notice (66 FR 31028) for the 5-year review of work RVUs 
and finalized these work RVUs. In addition, we acknowledged comments 
received in response to a discussion of modifier-62, which is used to 
report the work of co-surgeons. The November 2001 final rule also 
updated the list of services that are subject to the physician self-
referral prohibitions in order to reflect CPT and Healthcare Common 
Procedure Coding System (HCPCS) code changes that were effective 
January 1, 2002. All these revisions ensure that our payment systems 
are updated to reflect changes in medical practice and the relative 
value of services. This final rule also conformed our regulations to 
reflect statutory provisions of Medicare, Medicaid, and State Child 
Health Insurance Program (SCHIP) Benefits Improvement and Protection 
Act of 2000 (Pub. L. 106-554) (BIPA) concerning: the mammography 
screening benefit; biennial screening pelvic examinations for certain 
beneficiaries; expanded coverage for screening colonoscopies to all 
beneficiaries; annual glaucoma screenings for high-risk beneficiaries; 
coverage for medical nutrition therapy services for certain 
beneficiaries; expanded payment for telehealth services; payment for 
certain Indian Health Service for some services under the physician fee 
schedule; and revision of the payment for certain physician pathology 
services.
    In the December 31, 2002 final rule with comment period (67 FR 
79966), we refined resource-based practice expense RVUs and made other 
changes to Medicare Part B policy. These included: The pricing of the 
technical component for positron emission tomography (PET) scans, 
Medicare qualifications for clinical nurse specialists, a process to 
add or delete services to the definition of telehealth, the definition 
for ZZZ global periods, global period for surface radiation, and 
application of endoscopic reduction rules for certain codes. In 
addition, this rule: Updated the codes subject to physician self-
referral prohibitions, expanded the definition of a screening fecal-
occult blood test, and modified our regulations to expand coverage for 
additional colorectal cancer screening tests through our national 
coverage determination process. We also made revisions to the SGR, the 
anesthesia conversion factor (CF), and the work values for some 
gastroenterologic services. We finalized the calendar year (CY) 2002 
interim RVUs and assigned interim RVUs for new and revised procedure 
codes for CY 2003, clarified the enrollment of therapists in private 
practice and the policy regarding services and supplies incident to a 
physician's professional services, and made technical changes to the 
definition of outpatient rehabilitation services.
    This final rule also revised the regulations at Sec.  485.618 to 
allow registered nurses (RNs) to provide emergency care in certain 
critical access hospitals (CAHs) in frontier areas (an area with fewer 
than six residents per square mile) or remote locations (locations 
designated in a State's rural health plan that we have approved).
    As required by statute this final rule also announced that the 
physician fee schedule update for CY 2003 was -4.4 percent, the initial 
estimate of the SGR for CY 2003 was 7.6 percent, and the CF for CY 2003 
was $34.5920, effective March 1, 2003. However, on February 28, 2003 
(68 FR 9567), after enactment of the Consolidated Appropriations 
Resolution of 2003 (Pub. L. 108-7), we published a final rule that 
revised the estimates used to establish the SGRs for fiscal years 1998 
and 1999 and announced a 1.6 percent increase in the CY 2003 physician 
fee schedule CF for March 1 to December 31, 2003. The CF from March 1 
to December 31, 2003 is $36.7856 and the anesthesia CF for this period 
is $17.05. All other provisions of the December 31, 2002 final rule 
were unchanged by the rule published February 28, 2003.

C. Components of the Fee Schedule Payment Amounts

    Under the formula set forth in section 1848(b)(1) of the Act, the 
payment amount for each service paid under the physician fee schedule 
is the product of three factors--(1) a nationally uniform relative 
value for the service; (2) a geographic adjustment factor (GAF) for 
each physician fee schedule area; and (3) a nationally uniform 
conversion factor (CF) for the service. The CF converts the relative 
values into payment amounts.
    For each physician fee schedule service, there are three relative 
values--(1) an RVU for physician work; (2) an RVU for practice expense; 
and (3) an RVU for malpractice expense. For each of these components of 
the fee schedule, there is a geographic practice cost index (GPCI) for 
each fee schedule area. The GPCIs reflect the relative costs of 
practice expenses, malpractice insurance, and physician work in an area 
compared to the national average for each component.
    The general formula for calculating the Medicare fee schedule 
amount for a given service in a given fee schedule area can be 
expressed as:

Payment = [(RVU work x GPCI work) + (RVU practice expense x GPCI 
practice expense) + (RVU malpractice x GPCI malpractice)] x CF

    The CF for CY 2004 appears in section IX. The RVUs for CY 2004 are 
in Addendum B. The GPCIs for CY 2004 can be found in Addendum D.
    Section 1848(e) of the Act requires us to develop GAFs for all 
physician fee schedule areas. The total GAF for a fee schedule area is 
equal to a weighted average of the individual GPCIs for each of the 
three components of the service. In accordance with the statute, 
however, the GAF for the physician's work reflects one-quarter of the 
relative cost of physician's work compared to the national average.

D. Development of the Relative Value System

1. Work Relative Value Units (RVUs)
    Approximately 7,500 codes represent services included in the 
physician fee schedule. The work RVUs established for the 
implementation of the fee schedule in January 1992 were developed with 
extensive input from the physician community. A research team at the 
Harvard School of Public Health developed the original work RVUs for 
most codes in a cooperative agreement with us. In constructing the 
vignettes for the original RVUs, Harvard worked with expert panels of 
physicians and obtained input from physicians from numerous 
specialties.
    The RVUs for radiology services were based on the American College 
of Radiology (ACR) relative value scale,

[[Page 63199]]

which we integrated into the overall physician fee schedule. The RVUs 
for anesthesia services were based on RVUs from a uniform relative 
value guide. We established a separate CF for anesthesia services, and 
we continue to recognize time as a factor in determining payment for 
these services. As a result, there is a separate payment system for 
anesthesia services.
2. Practice Expense and Malpractice Expense Relative Value Units
    Section 1848(c)(2)(C) of the Act required that the practice expense 
and malpractice expense RVUS equal the product of the base allowed 
charges and the practice expense and malpractice percentages for the 
service. Base allowed charges are defined as the national average 
allowed charges for the service furnished during 1991, as estimated 
using the most recent data available. For most services, we used 1989 
charge data aged to reflect the 1991 payment rules, since those were 
the most recent data available for the 1992 fee schedule.
    Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 
103-432), enacted on October 31, 1994, required us to develop a 
methodology for a resource-based system for determining practice 
expense RVUs for each physician service. As amended by the BBA, section 
1848(c) required the new payment methodology to be phased in over 4 
years, effective for services furnished in 1999, with resource-based 
practice expense RVUs becoming fully effective in 2002. The BBA also 
required us to implement resource-based malpractice RVUs for services 
furnished beginning in 2000.

II. Specific Provisions for Calendar Year 2004

    In response to the publication of the August 15, 2003 proposed 
rule, (68 FR 49030), and the December 2002 interim final rule, (67 FR 
79966), we received approximately 2,433 comments. We received comments 
from individual physicians, health care workers, and professional 
associations and societies. The majority of comments addressed the 
physician fee schedule proposals related to the dialysis G codes, 
``incident to'' therapy services, and the geographic practice cost 
indices locality payment discussion issue.
    The proposed rule discussed policies that affected the RVUs on 
which payment for certain services would be based. Certain changes 
implemented through this final rule are subject to the $20 million 
limitation on annual adjustments contained in section 
1848(c)(2)(B)(ii)(II) of the Act.
    After reviewing the comments and determining the policies we would 
implement, we have estimated the costs and savings of these policies 
and added those costs and savings to the estimated costs associated 
with any other changes in RVUs for 2004. We discuss in detail the 
effects of these changes in the Regulatory Impact Analysis in section 
XIII.
    For the convenience of the reader, the headings for the policy 
issues correspond to the headings used in the August 15, 2003 proposed 
rule. More detailed background information for each issue can be found 
in the December 2002 interim final rule with comment period and the 
August 2003 proposed rule.

A. Resource-Based Practice Expense Relative Value Units

1. Resource-Based Practice Expense Legislation
    Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 
103-432), enacted on October 31, 1994, required us to develop a 
methodology for a resource-based system for determining practice 
expense RVUs for each physician's service beginning in 1998. In 
developing the methodology, we were to consider the staff, equipment, 
and supplies used in providing medical and surgical services in various 
settings. The legislation specifically required that, in implementing 
the new system of practice expense RVUs, we apply the same budget-
neutrality provisions that we apply to other adjustments under the 
physician fee schedule.
    Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33), enacted on August 5, 1997, amended section 1848(c)(2)(B)(ii) 
of the Act and delayed the effective date of the resource-based 
practice expense RVU system until January 1, 1999. In addition, section 
4505(b) of the BBA provided for a 4-year transition period from charge-
based practice expense RVUs to resource-based RVUs.
    Further legislation affecting resource-based practice expense RVUs 
was included in the Medicare, Medicaid and State Child Health Insurance 
Program (SCHIP) Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 
106-113) enacted on November 29, 1999. Section 212 of the BBRA amended 
section 1848(c)(2)(B)(ii) of the Act by directing us to establish a 
process under which we accept and use, to the maximum extent 
practicable and consistent with sound data practices, data collected or 
developed by entities and organizations. These data would supplement 
the data we normally collect in determining the practice expense 
component of the physician fee schedule for payments in CY 2001 and CY 
2002. (In the 1999 final rule (64 FR 59380), we extended, for an 
additional 2 years, the period during which we would accept 
supplementary data.)
2. Current Methodology for Computing the Practice Expense Relative 
Value Unit System
    Effective with services furnished on or after January 1, 1999, we 
established a new methodology for computing resource-based practice 
expense RVUs that used the two significant sources of actual practice 
expense data we have available--the Clinical Practice Expert Panel 
(CPEP) data and the American Medical Association's (AMA) Socioeconomic 
Monitoring System (SMS) data. The methodology was based on an 
assumption that current aggregate specialty practice costs are a 
reasonable way to establish initial estimates of relative resource 
costs for physicians' services across specialties. The methodology 
allocated these aggregate specialty practice costs to specific 
procedures and, thus, can be seen as a ``top-down'' approach.

a. Major Steps

    A brief discussion of the major steps involved in the determination 
of the practice expense RVUs follows. (Please see the November 1, 2001 
final rule (66 FR 55249) for a more detailed explanation of the top-
down methodology.)
    [sbull] Step 1--Determine the specialty specific practice expense 
per hour of physician direct patient care. We used the AMA's SMS survey 
of actual aggregate cost data by specialty to determine the practice 
expenses per hour for each specialty. We calculated the practice 
expenses per hour for the specialty by dividing the aggregate practice 
expenses for the specialty by the total number of hours spent in 
patient care activities.
    [sbull] Step 2--Create a specialty specific practice expense pool 
of practice expense costs for treating Medicare patients. To calculate 
the total number of hours spent treating Medicare patients for each 
specialty, we used the physician time assigned to each procedure code 
and the Medicare utilization data. We then calculated the specialty 
specific practice expense pools by multiplying the specialty practice 
expenses per hour by the total physician hours.
    [sbull] Step 3--Allocate the specialty specific practice expense 
pool to the specific services performed by each specialty. For each 
specialty, we

[[Page 63200]]

divided the practice expense pool into two groups based on whether 
direct or indirect costs were involved and used a different allocation 
basis for each group.
    (i) Direct costs--For direct costs (which include clinical labor, 
medical supplies, and medical equipment), we used the procedure 
specific CPEP data on the staff time, supplies, and equipment as the 
allocation basis.
    (ii) Indirect costs--To allocate the cost pools for indirect costs, 
including administrative labor, office expenses, and all other 
expenses, we used the total direct costs combined with the physician 
fee schedule work RVUs. We converted the work RVUs to dollars using the 
Medicare CF (expressed in 1995 dollars for consistency with the SMS 
survey years).
    [sbull] Step 4--For procedures performed by more than one 
specialty, the final procedure code allocation was a weighted average 
of allocations for the specialties that perform the procedure, with the 
weights being the frequency with which each specialty performs the 
procedure on Medicare patients.

b. Other Methodological Issues

(i) Nonphysician Work Pool
    For services with physician work RVUs equal to zero (including the 
technical components of radiology services and other diagnostic tests), 
we created a separate practice expense pool using the average clinical 
staff time from the CPEP data and the ``all physicians'' practice 
expense per hour.
    We then used the adjusted 1998 practice expense RVUs to allocate 
this pool to each service. We have removed services from the 
nonphysician work pool if the requesting specialty predominates 
utilization of the service. Also, for all radiology services that are 
assigned physician work RVUs, we used the adjusted 1998 practice 
expense RVUs for radiology services as an interim measure to allocate 
the direct practice expense cost pool for radiology specialties to the 
most appropriate SMS specialty.
(ii) Crosswalks for Specialties Without Practice Expense Survey Data
    Since many specialties identified in our claims data did not 
correspond exactly to the specialties included in the SMS survey data, 
it was necessary to crosswalk these specialties to the most appropriate 
SMS specialty.
(iii) Physical Therapy Services
    Because we believe that most physical therapy services furnished in 
physicians' offices are performed by physical therapists, we 
crosswalked all utilization for therapy services in the CPT 97000 
series to the physical and occupational therapy practice expense pool.
3. Practice Expense Proposals for Calendar Year 2004
a. Nonphysician Workpool
    The nonphysician work pool is a special methodology that we used to 
determine practice expense RVUs for many services that do not have 
physician work RVUs. While the nonphysician work pool is of benefit to 
many of the services that were originally included, we have allowed 
specialties to request that their services be removed from the pool. 
Because the nonphysician work pool includes a variety of services 
performed by many different specialties, we use the ``all physician'' 
average practice expense per hour in place of a specialty-specific 
practice expense per hour.
    As discussed in the August 15, 2003 proposed rule, we are 
continuing to study the alternatives that are available and any 
modifications to the nonphysician workpool would be published in 
proposed rulemaking.
    Comment: Several specialty societies expressed support for the 
ongoing study of this complex issue and appreciate that any 
modifications to the nonphysician workpool would be published as 
proposed rulemaking for review and comment prior to implementation. A 
biopharmaceutical company commented that we should move forward to 
develop a new methodology that better recognizes actual resource 
consumption so that we can develop a preferable alternative.
    Response: We are appreciative of the support and will continue to 
study this issue.

b. Supplemental Practice Expense Survey Data

i. Survey Criteria and Submission Dates

    As required by the BBRA, we established criteria to evaluate data 
collected by organizations to supplement the data normally used in 
determining the practice expense component of the physician fee 
schedule. We have required supplementary survey data to be submitted by 
August 1 to be considered for computing practice expense RVUs for the 
following year. We proposed to change the required submission date to 
March 1, which would allow us to publish our decisions regarding survey 
data in the proposed rule and provide an opportunity for public comment 
on survey results. We also proposed to extend for an additional 2 years 
the period for accepting survey data that meets the criteria set forth 
in the November 2000 final rule (as modified in the December 31, 2002 
final rule). The deadline for submission of the supplemental data to be 
considered in CY 2005 and CY 2006 would be March 1, 2004 and March 1, 
2005, respectively.
    Comment: Specialty societies expressed appreciation for our 
proposal to extend the deadline for submission of surveys. Commenters 
also approved of our proposal to change the due date for submission of 
supplemental practice expense survey data to March 1, so that the 
implications of the use of the survey data could be discussed in the 
proposed rule.
    Response: We will implement the change in the submission dates for 
supplementary surveys as proposed. The deadline for submission of the 
supplemental data to be considered in CY 2005 and CY 2006 would be 
March 1, 2004 and March 1, 2005, respectively. We will revise Sec.  
414.22(b)(6)(ii) to reflect this change.

ii. Submission of Supplemental Surveys

    The College of American Pathologists (CAP) submitted supplemental 
survey data for independent laboratories for consideration for CY 2004. 
Our contractor, The Lewin Group, evaluated the data and has recommended 
acceptance.
    Comment: Based on our proposal to revise the date for submission of 
supplemental survey data, CAP requested that we delay incorporation of 
this survey data until next year's proposed rule. CAP also expressed an 
interest in being able to evaluate the combined effects of the use of 
the new survey data along with the technical change for pathology 
services before the changes are implemented. Therefore, CAP requested 
that we also extend the moratorium on calculating the technical 
component as the difference between the global and professional 
component practice expense RVUs by one additional year, as discussed in 
the August 15, 2003 proposed rule. This request for a delay in 
incorporating the new survey data, as well as extending the moratorium 
was supported by the AMA and several specialty societies.
    Response: We agree with the comments that suggest extending by one 
year the moratorium on calculating the technical component practice 
expense RVU as the difference between the global and professional 
component RVUs for pathology services. We also agree with comments 
suggesting that we not incorporate the CAP survey into the practice 
expense methodology until next year. We will evaluate the CAP

[[Page 63201]]

survey in next year's proposed rule at the same time we show the effect 
of the above described change for pathology services.

c. Practice Expense for a professional component service

    While we typically assign all staff, equipment and supply costs for 
services with professional and technical components (PC and TC) to the 
technical portion of the service, in the proposed rule we discussed 
limited instances where it is appropriate to assign direct inputs to a 
PC service. We proposed to modify the practice expense methodology to 
allow direct inputs to be added to PC services when these inputs are 
clearly associated with the professional service, including when the 
PEAC makes such recommendations. Specifically we proposed to add the 
PEAC recommended staff times to the PC of the following cardiac 
services: CPT codes 93508, 93510, 93511, 93514, 93524, 93526, 93527, 
93528, 93529, 93530, 93531, 93532, 93533 and 93624.
    Comment: The RUC, the AMA, the American College of Physicians and 
societies representing cardiologists, cardiac rhythm specialists, 
interventional radiologists, nuclear medicine, chest physicians, 
radiation oncologists, radiologists, endocrinologists and 
dermatologists expressed support for this change in methodology. 
Commenters were also in agreement with the specific CPT codes mentioned 
in the proposed rule, but requested that direct inputs also be added to 
the PC of CPT codes 93619, 93620 and 93642, which were reviewed at the 
January PEAC meeting. The RUC comment indicated that additional codes 
might be identified at future PEAC/RUC meetings.
    Response: We will finalize the proposed assignment of direct 
practice expense to the proposed 14 cardiac services and will add the 
PEAC recommended inputs to the PC of CPT codes 93619, 93620 and 93642, 
as requested by the commenters.

d. Utilization Data

    We use Medicare utilization data in the development of specialty-
specific practice expense RVUs that are then weight averaged to 
determine a single practice expense RVU per code. Prior to 2003, we 
used the most recent complete year of utilization data to determine the 
practice expense RVUs. In the December 31, 2002 final rule (67 FR 
79982), we adopted a policy of using the 1997 through 2000 Medicare 
utilization in the practice expense methodology. For new codes created 
since 2000, there are no Medicare utilization data. In the August 15, 
2003 rule we proposed to follow a similar practice to the one described 
above and use specialty-specific Medicare utilization data for codes 
created after 2000 at the first opportunity they become available to 
us. Since we will not have any utilization data at the time we first 
establish practice expense RVUs for a new code, we proposed that we 
continue, whenever possible, to make an assumption about the specialty 
that will likely provide the service or to use the ``all physician'' 
average when we do not have sufficient information to assign any given 
specialty.
    Comment: The specialty societies representing internal medicine, 
rheumatology and pulmonary medicine supported our proposal to use 1997 
through 2000 Medicare utilization data for all codes that were in 
existence at that time and to use specialty-specific Medicare 
utilization data for codes created after 2000 when utilization data 
first become available, using the ``all physician'' average when we do 
not have sufficient information to assign a given specialty. These 
commenters, as well as several others, suggested that the RUC and the 
specialty societies could provide information on the specialties that 
will likely perform a new service to minimize the potential changes to 
the practice expense RVUs that will occur when we substitute actual for 
estimated utilization. However, a specialty society representing 
gastroenterology expressed concern that we are moving forward with 
plans to shift the basis of our methodology for compiling data to a 
five-year basis. The commenter urged us to not make changes until 
extensive impact comparisons are conducted that can be evaluated by 
physician community.
    Response: We will implement our proposal to use specialty-specific 
Medicare utilization data for codes created after 2000 at the first 
opportunity they become available to us. We will also continue, 
whenever possible, to make an assumption about the specialty that will 
likely provide the service or to use the ``all physician'' average when 
we do not have sufficient information to assign any given specialty. 
Information about the specialty we assign to a code that has no 
utilization data can be found in the utilization data files we make 
available on the CMS web site following final rule publication. With 
respect to the comment about shifting to a 5-year basis of utilization 
data for the practice expense methodology, we are making no change in 
policy for codes that existed in the 1997 to 2000 period. We are using 
only the later year utilization data for codes that have been created 
since that time. Any information from the RUC that could assist us in 
this process would be welcomed.
    Comment: A specialty society representing colon and rectal surgeons 
agreed with our general utilization methodology, but disagreed that 
averaged 1997-2000 utilization data should be used for all codes that 
were not in existence for the entire period. The commenter argued that 
the frequency for these codes might be artificially low because the 
coding was new and that this may impact the relativity between new and 
old codes in the same family with similar inputs. The society suggested 
that any code that did not exist during the entire 1997-2000 period 
default to 2002 or most recent data.
    Response: As we have explained, the Medicare utilization is 
important to the practice expense methodology because it determines 
which specialty scaling factors will be applied to the estimated 
practice expense input values in determining the practice expense RVUs 
for each service. The proportion of the volume billed by each specialty 
is more important to determining the practice expense RVU for a given 
service than the total volume. If the code is low in volume but the 
proportion of the code's volume billed by each specialty is generally 
consistent over time, there will be little or no difference in a code's 
practice expense RVUs, whether we use its initial year of utilization 
or a later year to determine its value.
    Comment: Commenters representing dermatology as well as a 
pharmaceutical company expressed concern regarding the decrease in 
payment for photodynamic therapy, CPT code 95657. The commenters noted 
our discussion in the proposed rule indicating that this reduction in 
the practice expense RVUs is occurring because of updates to the 
Medicare utilization data used in the practice expense methodology. As 
a result of the updated utilization data, the practice expense 
methodology now uses the dermatology scaling factor (0.54) for supplies 
instead of the all physician average (1.29), and this change leads to 
the reduction in payment for the code. The commenters urged us to 
reconsider the proposal and at least to reinstate physicians' ability 
to bill separately in 2004 for the light-activating agent under the 
appropriate J code and also to remove the drug from the practice 
expense portion of the procedure.
    Response: One of the functions of the utilization data in our 
practice expense methodology is to assign all procedures to the 
specialty-specific cost pools of the

[[Page 63202]]

specialty or specialties performing them. Each cost pool has its own 
scaling factor. This scaling factor is used to scale the aggregate CPEP 
procedure-level costs for a specialty to the aggregate costs for the 
same specialty as determined by the SMS practice expense data. As we 
indicated in the proposed rule, we do not have utilization data upon 
which to determine the practice expense RVUs for a new code at the time 
it is created. As a default, we have assigned many new codes the ``all 
physician'' scaling factor until we have the data to move these codes 
into the appropriate specialty cost pools. Because it allows us to 
apply the appropriate specialty scaling factor, the use of the updated 
utilization data in the practice expense methodology can lead to 
increases or decreases in the value of a code, even though its practice 
expenses remain unchanged. In this case, the supplies scaling factor 
for dermatology is lower than that for ``all physicians,'' leading to a 
decrease in practice expense RVUs when the dermatology scaling factor 
was applied to the CPEP data of the photodynamic therapy service.
    We believe the initial practice RVUs for photodynamic therapy were 
too high, because the later information on Medicare utilization 
indicates that we should have used the dermatology scaling factor which 
would have produced a lower practice expense value. As we indicate 
above, we are working to minimize changes that will occur in the 
practice expense RVUs for a service by making an initial assumption 
about which specialty will likely bill us for a service. However, we 
believe our policy for new codes should be consistent with how we 
determine the practice expense RVUs for existing codes, even if updates 
to the Medicare utilization data lead to increases or decreases in the 
practice expense RVUs.
    Though we believe that it is appropriate to use the updated 
utilization that results in a reduction in payment for CPT code 96567, 
we will pay separately for the light activating agent beginning January 
1, 2004. However, we are also further considering whether Medicare 
should pay separately for certain topical drugs in certain 
circumstances. Any change in policy would be discussed in future 
rulemaking.
    Comment: Specialty societies representing radiation oncology, as 
well as individual commenters, expressed concern about the decrease in 
payment for the intensity modulated radiation therapy (IMRT) treatment 
service, CPT code 77418. The commenters stated that this was due to a 
``quirk'' in the utilization data relating to new codes and requested 
that this code be priced by the non-physician work pool methodology.
    Response: We will calculate the practice expense RVUs for the IMRT 
treatment service, CPT code 77418, using the nonphysician workpool 
methodology. This will be consistent with the way we currently 
calculate the practice expense for all other radiation therapy services 
with no physician work RVUs.
    Comment: The specialty society representing radiation oncology also 
noted that there was a reduction in the practice expense RVUs for the 
intensity modulated radiation therapy planning procedure, CPT code 
77301. A remote cardiac monitoring service questioned why the use of 
new utilization data could decrease the value of a code such as HCPCS 
code G0249 for the provision of test material and equipment for home 
INR monitoring.
    Response: Both CPT code 77301 and HCPCS code G0249 were new codes 
for which we did not have utilization data and which were initially 
assigned the ``all physician'' scaling factor. As described above, now 
that we have the utilization data, the services have been placed in the 
specialty-specific cost pools based on how the service is billed to 
Medicare, which have lower scaling factors than the ``all physician.'' 
This shift has led to the reduced practice expense RVUs for CPT code 
77301. If we had placed this code in the radiation oncology cost pool 
to begin with, it would have had the reduced practice expense payments 
for the past two years as well. HCPCS code G0249 will actually have 
increased practice expense RVUs in 2004 due to the effect of the 
repricing of supplies.
    Comment: We received one comment that questioned how updated 
utilization data could have such a huge and direct effect on specific 
codes. The commenter requested clarification from us on the workings of 
the utilization data within the practice expense methodology so that 
the public will understand how utilization data will affect new 
technologies in the future.
    Response: As explained above, one of the functions of the 
utilization data in our practice expense methodology is to assign all 
procedures to the specialty-specific cost pools of the specialty or 
specialties performing them. If we do not know the specialty, we have 
used ``all physician'' scaling factors. The ``all physician'' scaling 
factors could be higher or lower than the specialty-specific scaling 
factor and produce different RVUs for the code. For instance, CPT code 
77301-26 is a PC service that has no direct cost inputs. Thus, its 
practice expense RVUs are affected only by the indirect cost scaling 
factor. To develop the 2003 practice expense RVUs for this code, we 
adjusted indirect costs allocated to this code by the ``all physician'' 
indirect cost scaling factor of 0.57. However, for 2004, we have 
Medicare utilization data from 2002 for this procedure code. Radiation 
oncologists and radiologists respectively billed Medicare for 67 
percent and 30 percent of the total volume of services provided to 
Medicare patients in 2002. The weighted average scaling factor for all 
the specialties that bill Medicare for this procedure code is 0.48. 
Since we are adjusting indirect costs by 0.48 instead of 0.57, the 
final practice expense value is lower.

e. Practice Expense Advisory Committee (PEAC)

    The PEAC, a subcommittee of the RUC, has, since 1999, been 
providing us with recommendations for refining the direct practice 
expense inputs (clinical staff, supplies, and equipment) for existing 
CPT codes.

1. Recommendations on CPEP Inputs for 2003

    In the December 31, 2002 proposed rule, we responded to the PEAC 
recommendations for the refinement to the CPEP direct practice expense 
inputs for over 1200 codes, including refinements to codes from almost 
every major specialty. In addition, the recommendations included 
standardized times for office-based clinical staff for services 
provided during a patient's hospitalization and for discharge day 
management services, as well as pre-service clinical staff times for 
323 neurosurgery procedures. We reviewed and accepted all of the 
recommendations. We received the following comments on these revisions.
    Comment: We received comments from specialty societies representing 
dermatology, dermatolgic surgery and Mohs surgery expressing concern 
regarding the decrease in practice expense RVUs for skin biopsy 
procedures, CPT codes 11100 and 11101 and the destruction of benign or 
premalignant lesion services, CPT codes 17000 and 17003. The commenters 
questioned whether the reductions reflect errors in the validated 
practice expense inputs used in the practice expense calculations.
    Response: We have checked the practice expense inputs and found 
that these match the clinical staff, supply and equipment inputs as 
recommended by the RUC. The reduction in practice expense RVUs was 
caused by the

[[Page 63203]]

refinement of these inputs, which, in turn, was based on the 
presentation made to the PEAC by the dermatology specialty society. We 
will, therefore, not make any further revisions to the practice expense 
inputs for these services in this final rule.

2. Recommendations on CPEP Inputs for 2004

    In the August 15, 2003 proposed rule we included the PEAC 
recommendations from meetings held in September of 2002 and January 
2003 as well as recommendations on the refinements to the clinical 
staff time for all 90-day global services. In addition, the PEAC 
convened a workgroup to make recommendations on the refinement of all 
the 116 remaining evaluation and management codes. We reviewed the 
submitted PEAC recommendations and proposed to accept them.
    Comment: The American Osteopathic Association expressed 
appreciation that we supported the recommended changes for the 
osteopathic manipulative treatment codes and commended us for accepting 
the PEAC recommendations for the clinical staff times for 90-day global 
codes. The American College of Obstetricians and Gynecologists stated 
that our acceptance of the PEAC recommendations is an example of 
exceptional cooperation and collaboration in meeting the healthcare 
needs of Americans served by the Medicare program. The American Academy 
of Dermatology applauded our acceptance of the year's PEAC 
recommendations. The AMA and the American College of Radiology stated 
that they appreciate our recognition of the significant resources 
specialty societies have devoted to the practice expense refinement 
process and is thankful that our practice expense staff avail 
themselves of specialty society input. The American College of Surgeons 
also supported our acceptance of the PEAC recommendations, including 
the decision to permit exceptions to the standard pre-service times for 
some surgical procedures. The College other specialty societies also 
expressed appreciation for our commitment to the refinement process.
    Response: We, in turn, are appreciative of these positive comments. 
We believe that it is only because of the cooperative working 
relationship between the specialty societies, the AMA and CMS that 
there has been such a high level of success in tackling practice 
expense refinement.
    Comment: The American College of Physicians as well as other 
specialty societies representing surgeons, otolaryngologists, 
podiatrists, geriatric psychiatrists, obstetricians and gynecologists, 
cataract and refractive surgeons, neurosurgeons, dermatologists, 
rheumatologists, radiologists and radiation oncologists supported our 
inclusion of the PEAC recommendations in the proposed rule because this 
would better enable specialty societies to address their impact and 
make comments prior to publication of the final rule.
    However, specialty societies representing chest physicians and 
thoracic physicians disagreed with our decision to change our previous 
practice of including the PEAC recommendations in the final, rather 
than the proposed rule, because this meant that the recommendations 
from the March PEAC meeting were not included for this year. The 
society argued that changing this long-standing policy without 
announcing it in the Federal Register is inappropriate. The comment 
also contended that the specialty societies agreed to the inputs at the 
PEAC meeting; therefore, negative comments would not be forthcoming.
    Response: We discussed this issue at the January PEAC meeting and 
indicated that we were considering including the PEAC recommendations 
in the proposed rule and that the March recommendations would most 
likely not be included. We made this decision because, now that the 
PEAC is refining such a large number of codes, the revisions to the 
inputs were not only changing the practice expense RVUs of the refined 
codes, but also the values of services that were not refined. 
Therefore, we believed it was prudent that revisions be subject to 
comment before the revisions were implemented.
    Comment: The specialty society representing podiatry identified 
some discrepancies between the PEAC recommendations and the inputs in 
the CPEP database for CPT codes 10060, 11000, 11055, 11056, 11057 and 
11752 and requested that these be corrected.
    Response: We have made the corrections as requested.
    Comment: The American Society of Transplant Surgeons (ASTS) 
commented that it is not appropriate to apply either the PEAC-approved 
standard clinical staff times or RN/LPN/MTA staff blend for 90-day 
global procedures to the transplant recipient or living donor services. 
ASTS stated that it had been unaware that the PEAC was applying the 
standard to all 90-day services unless a case was made to the PEAC that 
the times should be increased. ASTS argued that there are substantial 
atypical staff times required for transplant recipients due, in large 
part, to the intensive education required for the transplant patient. 
The commenter noted that the three new CPT codes for living donor 
hepatectomies, CPT codes 47140-47142, were given increased pre-service 
clinical staff time by the RUC and have an RN as the staff type. ASTS 
requested that the current clinical staff times be retained and that an 
RN be assigned rather than the blended staff type to the following 
transplant services: CPT codes 32851, 32852, 32853, 32854, 33935, 
33945, 47135, 47136, 48554, 48556, 50320, 50360, 50365, 50380, 50547.
    Response: It does seem reasonable that at least some of these 
services would have increased pre-times as do the living donor 
hepatectomies recently reviewed by the RUC. Therefore, we will restore 
the original CPEP clinical staff pre-times and use the RN staff type 
for the above services on an interim basis for the coming year. We 
anticipate that the society will bring all of these codes to the PEAC 
for review for either the January or March meeting to ensure that the 
times for the codes receive the same scrutiny as did the new transplant 
codes. It should be noted that a few of the codes have lower original 
CPEP pre-time than the PEAC standard of 60 minutes; for those codes we 
did not change the PEAC standard time. We also are not revising the 
post-procedure clinical staff times for these codes, because the 
current times are in line with the post-service times assigned to the 
new living donor hepatectomy codes recently reviewed by the RUC.
    Comment: A commenter noted that high dose rate (HDR) brachytherapy 
CPT codes 77781, 77782, 77783 and 77784 were not listed in Addendum C 
of the proposed rule. Since these codes were approved by the PEAC and 
forwarded to CMS, ACR questioned why these codes were not listed.
    Response: The CPEP data base files had been revised to reflect the 
PEAC recommendations for these codes. It was an oversight that they 
were not included in Addendum C.
    Comment: The American College of Surgeons listed several possible 
errors in the CPEP database:
    CPT code 11450--missing 1 minute of staff time
    CPT codes 10080, 10081, 11770, 12032, 12035, 12046, 12047, 21550, 
21920, 37609, 38300, 45300-45327, and 46600-46615--missing correct 
number of gloves.
    CPT codes 45900, 45905, 45910, 47382, 49320, 49321, 49322, 49422, 
49429--supplies listed incorrectly--have nonfacility inputs when PEAC 
recommended none in office setting.

[[Page 63204]]

    Response: We thank the College for checking the database so 
carefully. We have made the suggested corrections, with the following 
notes: For CPT codes 10080, 10081 and 11770, the PEAC recommendation 
listed 5 gloves, not 6. For CPT codes 45300-45327 and 46600-46615, we 
adjusted the quantity of unsterile gloves to reflect that there are 2 
pair in the minimum visit supply package; in addition, CPT codes 45321 
and 45327 were not priced in the nonfacility setting.
    Comment: The American Society of Colon and Rectal Surgeons noted a 
few errors in the CPEP supply database. The supply inputs had not been 
changed to match the accepted new recommendations for CPT codes 45900, 
45905, 45910, 47382, 49320, 49321, 49322, 49422 and 49429.
    Response: We have made the corrections to the supply database and 
thank the specialty for bringing this to our attention.
    Comment: The American Speech-Language-Hearing Association (ASHA) 
questioned the proposed 28 percent reduction in the practice expense 
for CPT code 92507, Treatment of speech, language, voice, 
communication, auditory processing and/or aural rehabilitation status. 
The reduction is attributable to a decrease in clinical staff time. 
ASHA contended that the PEAC recommendation was based on a vignette for 
a child receiving such therapy, but that the time involved with a 
typical adult patient receiving this treatment is much longer. ASHA 
stated that a more reasonable time for clinical staff for this service 
is 69 minutes compared to the proposed 46 minutes.
    Response: We understand that the scenario for performing this 
service for a child might be very different than for an adult because 
an adult can participate in a more protracted therapy session. Because 
it is not clear to us at this time what would be the typical scenario, 
we will, on an interim basis, average the clinical staff time needed 
during a speech therapy session for a child with that suggested by ASHA 
for an adult. We will, therefore, assign 58 minutes of clinical staff 
time to this service, with the expectation that ASHA will present CPT 
code 92507 for further discussion and review at the PEAC.
    Comment: We received several comments in response to our acceptance 
of PEAC recommendations for evaluation and management (E/M) codes that 
reduced payment rates for six nursing home services (CPT codes 99301-
99303 and 99311-99313) and two home visit codes (CPT codes 99348 and 
99350). This payment reduction is primarily due to a decrease in the 
clinical staff time assigned to these services.
    The American Academy of Family Physicians (AAFP) supported our 
acceptance of the PEAC recommendations for the E/M nursing facility 
services. The commenter noted that current practice expenses are higher 
for services provided in the non-SNF nursing facility than those 
provided in the SNF facility. The commenter contended that the direct 
practice expense inputs should not vary based on the type of nursing 
facility setting and supported the elimination of the current 
differential in the practice expense RVUs between the SNF and non-SNF 
facility setting.
    However, the American Medical Directors Association (AMDA) 
representing long term care physicians, the American Geriatrics Society 
(AGS) and a health care management company, Health Essentials, all 
disagreed with our decision to accept the E/M nursing facility PEAC 
recommendations and asked us to reconsider our decision to implement 
them in 2004. The request to delay implementation was echoed by the 
American Academy of Home Care Physicians and AGS relating to the two E/
M home visit codes.
    The home care physicians argued that the PEAC recommendations for 
the two home visit codes are flawed because these codes have not yet 
been surveyed by the specialty performing this service. The commenters 
also contended that their views were not represented when the PEAC 
considered the refinements of the E/M home visit codes. Similarly, the 
AMDA noted that the PEAC workgroup responsible for formulating the 
recommendations for the nursing facility codes did not include long 
term care physicians. The AMA also commented on this issue and 
expressed concern that the PEAC recommendations did not include the 
views of all the relevant medical specialties and requested that we 
delay implementation of these E/M code recommendations to allow 
impacted medical specialties an opportunity to present new information 
to the PEAC.
    In addition, the AMDA expressed concern regarding the current work 
RVUs for nursing home visit services.
    Response: At the time the PEAC recommendations were forwarded to 
CMS, we agreed with the views expressed by the AFPP as to the 
reasonableness of the practice expense recommendations for the E/M 
codes for the nursing facility and home visits. However, we are also of 
the opinion that the relevant medical specialties should be given the 
opportunity to have their views considered by the PEAC. Consequently, 
we will not go forward with these E/M recommendations in 2004. This 
will allow time for the PEAC to reconsider the eight E/M codes with 
input from representatives from the nursing home and home visit 
specialties. We will use current CPEP practice expense inputs to price 
these codes for 2004.
    With regard to the concern expressed about the work RVUs for the 
nursing home visits, in the 2004 final rule we will solicit 
recommendations on codes to be reviewed during the next 5-year review 
of work and we suggest that the society recommend review of these 
codes.
    Comment: A specialty society representing gastroenterologists 
commented that the increased clinical staff pre-time added to certain 
colorectal procedures needs to be applied equally to 
gastroenterologists who provide those services.
    Response: We have a single payment for each procedure regardless of 
the specialty performing the service. Therefore, gastroenterologists 
will be paid the same as colorectal surgeons when performing those 
services for which we allowed increased pre-service clinical staff 
time.
    Comment: The American College of Radiology submitted several 
corrections to the CPEP database for those instances where the database 
differed from the PEAC recommendations that we accepted. The College 
stated its appreciation for the opportunity to review the practice 
expense data file for completeness and accuracy and applauded our 
efforts to ensure that the database captures correct and complete 
practice expense data.
    Response: We thank the College for the time and effort expended in 
checking this detailed data. We have made revisions to 19 codes: We 
changed the quantity of sodium chloride injection for CPT codes 78306, 
78315, 78460, 78461, 78464, and 78465; adjusted the quantity of films 
for CPT code 76812; added missing supplies to CPT codes 77408, 77409, 
77411, 77412, 77414, 77416, 76830 and 77290; removed equipment that had 
been deleted from CPT codes 78478 and 78480; and corrected a 
typographical error in the pre-service clinical staff time for CPT 
codes 73218 and 75555.

g. Repricing of Clinical Practice Expense Inputs--Supplies

    We use the practice expense inputs (the clinical staff, supplies, 
and equipment assigned to each procedure) to allocate the specialty-
specific practice expense cost pools to the procedures

[[Page 63205]]

performed by each specialty. The costs of the original inputs assigned 
by the Clinical Practice Expert Panels (CPEP) were determined by our 
contractor, Abt Associates, based primarily on 1994 and 1995 pricing 
data from supply catalogs. In addition, for many items on the equipment 
and supply list, the associated costs were based on the recommendations 
of a CPEP panel member, rather than on actual catalog prices. 
Subsequent to the CPEP panels, equipment and supply items have also 
been added to the CPEP data, with the costs of the inputs provided by 
the relevant specialty society.
    We contracted with a consultant to assist in obtaining current 
pricing information and also to recommend revisions to improve the 
uniformity and consistency of the CPEP supply database. On the basis of 
these recommendations, in the August 15, 2003 proposed rule, we 
proposed updates to the cost information for supplies in the database. 
In addition, we proposed the following database revisions:

--Assignment of supply categories.

    We proposed that supplies be assigned to one of 14 categories.

--Consolidation/standardization of item descriptions.

    We proposed combining items which appeared to be duplicative and 
modifiying descriptions using a key first word when possible for easier 
identification of items. For example, ``mayo stand cover'' and ``drape, 
sterile Mayo'' have both been changed to ``drape, sterile, for Mayo 
stand.''

--Standardization of unit descriptions.

    The current CPEP database contains over 72 unit descriptions 
associated with supplies (for example, item, gram, and cup). To provide 
consistency and ensure that inputs in the database accurately reflect 
the quantity of an item used, we proposed to standardize the unit 
description of items. We also proposed to specifically identify items 
intended for single use through the use of ``uou'' (unit of use) 
following the unit. These changes were reflected in Addendum D of the 
proposed rule.
    There were also items that had not been identified or for which 
pricing information was not found that were included in Table 1 in the 
August 15 proposed rule. Items that we proposed to delete from the 
database were also identified in this table. We requested that 
commenters, particularly the relevant specialty groups, provide us with 
the needed pricing information with appropriate documentation. We also 
stated if we did not obtain verified pricing information for an item, 
it would be eliminated from the database.
    Comment: The RUC expressed appreciation for the enormity of the 
repricing project and stated that the proposed approach was well 
organized and comprehensive. The American Association of Orthopedic 
Surgeons also agreed that the assignment of supply categories would be 
helpful in future refinement activities. The American College of 
Physicians, the American College of Surgeons, and the American 
Urological Association expressed support for our proposal to create a 
numbering system and to standardize the descriptions of supply items to 
increase accuracy of use. The American Academy of Dermatology also 
supported this standardization of proposed ``unit of use'' as long as 
its application does not assume that ``one size fits all'' as some 
supplies may go from milliliter to liter in usage. The American Society 
of Cataract and Refractive Surgery and the Outpatient Ophthalmic 
Surgery Society thanked us for the repricing proposal because this will 
ensure that we are using the more accurate and up-to-date supply costs, 
thus reimbursing physicians more fairly. The American College of 
Radiology recognized the need to update supply and pricing information 
in the practice expense database and commended us for committing to 
this extensive project. The American College of Surgeons also agreed 
that the update of prices for supplies will improve the accuracy of the 
direct practice expense data. The Society of Nuclear Medicine commended 
us for committing to this extensive project. The American Urological 
Association also appreciated this effort and acknowledged it as a huge 
undertaking.
    Response: We appreciate the positive feedback and would like to 
thank all the staff of the specialty societies who worked with our 
contractor to obtain the most representative prices for all of the 
supplies in the CPEP input database.
    Comment: A specialty society representing podiatrists agreed with 
removal of hallux implant and the broach kit from the list of supplies 
to be included under practice expense as both are separately billable 
and the broach kit is also reusable. The commenter did not agree with 
removal of the sterile ankle tourniquet since this is packaged as a 
single use item. The comment included pricing information at $42.87 
each (with documentation) for this supply.
    Response: We will delete the hallux implant and the broach kit from 
the CPEP supply data. We will retain the ankle tourniquet using the 
pricing information supplied by the society.
    Comment: Several commenters expressed concern about the reduction 
in nonfacility practice expense for the interstitial laser coagulation 
of the prostate procedure, CPT code 52647. A manufacturer of endo-
surgery equipment stated that the main reason for this decrease was the 
decrease in the price assigned to the laser fiber used in this 
procedure. We had proposed a price of $290 for this item, but the 
commenter submitted documentation that indicated that the laser fiber 
should be priced at $850 for CPT code 52647. In addition, the commenter 
noted that we had proposed in Table 1 to delete the laser fiber because 
it was reusable; however, this was incorrect as the laser fiber used in 
this procedure could not be reused and should not be deleted from our 
supply list.
    Response: When the laser fiber was repriced, we believed the item 
included in the supply list for CPT code 52647 was the same as a 
``laser tip,'' which was priced at $290. We thank the commenters for 
clarifying the issue. We agree that the laser fiber used in this 
procedure is a disposable supply that we will retain in our CPEP supply 
data at the $850 price documented by the commenter.
    Comment: Commenters representing cardiac arrhythmia specialists and 
a remote cardiac monitoring system recommend that we not delete the 
transtelephonic monitor as a supply even though we are correct that the 
patient and physician re-use this supply during the course of the 
pacemaker's life. The specialty society commenter requested that the 
expense of this supply, which costs $190, should be spread out over 
approximately 5 years.
    Response: The transtelephonic monitor as described would be 
considered a piece of equipment, rather than a reusable supply. 
However, unless the equipment costs over $500, we consider it as an 
indirect cost and it is not included as a direct input. Therefore, we 
will delete the item from our list of direct practice expense inputs as 
proposed.
    Comment: A specialty society representing chest physicians agreed 
that the oximetry sensory probe, CPAP nasal pillow and flow sensor are 
reusable and should be deleted from the list of CPEP supply inputs. The 
society also agreed that albuterol is separately billable and should 
also be deleted. Another commenter, representing sleep medicine, agreed 
that the nasal pillow should be deleted. However, the commenter 
representing chest physicians and a commenter representing thoracic 
physicians disagreed with the proposal to delete

[[Page 63206]]

methacholine chloride because there is no ``J'' code to use when 
billing, thus forcing physicians to used an unlisted service code. The 
commenters also contended that the aerochamber should not be deleted 
because, although reusable, it has a life of only about six months and 
should be costed out accordingly. In addition, the commenters disagreed 
that the inhaler is separately billable because a multi-use canister is 
utilized for this test; therefore, the amount used from the canister 
for each test should be included in the practice expense.
    Response: We will delete the oximetry sensory probe, CPAP nasal 
pillow and flow sensor and albuterol from the list of CPEP supply 
inputs. We will also delete the aerochamber, because an item that is 
reusable over a six-month period cannot be classified as a disposable 
supply. The commenter is correct that there is not a HCPCS ``J'' code 
for methacholine chloride. Therefore, we will keep this in the supply 
database as requested so that physicians can avoid the burden of 
submitting paper claims. We also will keep the inhalant in the database 
using the quantity of 1 gram per procedure at $0.788.
    Comment: Specialty societies representing radiologists and 
interventional radiologists disagreed with the classification of the 
Arrow mechanical thrombectomy device as reusable. The commenter 
contended that this device is single-use because the difficulty in 
cleaning the intra-luminary surface areas could lead to a risk of 
contamination if the device is reused. Moreover, reprocessing the 
thrombectomy device may result in fatigue-related failure.
    The societies also disagreed with our contention that a Seldinger 
needle is reusable; rather a Seldinger needle is single-use and should 
not be removed as a supply item. It is the commenter's understanding 
that hospitals are not in the practice of resterilizing Seldinger 
needles.
    While generally favoring reorganization of CMS' supply listing for 
ease of use and not directly opposed to supply categories, one of the 
commenters was concerned over the potential loss of granularity of cost 
data associated with the use of supply categories and would oppose the 
averaging of costs for the supply categories unless it is appropriate 
to average from a cost and clinical standpoint. A similar comment was 
sent by the radiology specialty society.
    Response: We will retain the thrombectomy device and the Seldinger 
needle as disposable supplies in our CPEP input database. With regard 
to the classification of supplies, the commenter misunderstands the 
purpose of assigning a classification to each supply. This will not be 
used for pricing purposes in any way. Rather, the classifications can 
be useful as a way to sort the long list of supplies in the database to 
make it easier to find a particular item.
    Comment: The contractor responsible for helping us with the 
repricing of supplies informed us that a supply assigned to the 
endometrial ablation procedure, CPT code 58353, was listed as a 
catheter tray when it should be described as a thermal ablation balloon 
catheter at a price of $727. In addition, our contractor supplied us 
with prices for several new supply and equipment items mainly for 
otolaryngology, that were not priced in the proposed rule but were 
included in the PEAC recommendations.
    Response: We will make the appropriate changes in the CPEP supply 
and equipment databases.
    Comment: Commenters representing pediatricians, pulmonary 
physicians and family physicians pointed out that the new price we had 
assigned to the safety syringe and needle did not cover the actual cost 
of purchasing the entire needle stick device that is required by the 
Occupational Safety and Health Administration.
    Response: Our repricing contractor researched this issue for us and 
agreed that the price we were proposing was too low for the appropriate 
item. Based on documentation for a 10 ml Syringe with SafetyGlide 
Needle, the safety syringe and needle will be priced at $.435 each, 
instead of the $.28 that was proposed.
    Comment: A surgical society commenter pointed out that we listed an 
achalasia balloon in Table 1 in the proposed rule and indicated that it 
was a supply used with CPT codes 45905 and 45910. The commenter stated 
that both of these codes were refined in January and that they were not 
priced in the office setting; therefore the balloon should no longer be 
listed as a supply used with these services.
    Response: Our CPEP database currently has these codes priced only 
in the facility setting. However, these services had previously been 
priced in the office and Table 1 was apparently developed before the 
last of the PEAC recommendations were entered. The achalasia balloon no 
longer appears on the CPEP supply database.
    Comment: We received comments from the American College of 
Physicians and another medical society representing allergy and 
immunology with concerns about reductions in reimbursement for the five 
venom immunology CPT Codes (95145-95149). The commenters believe the 
reductions are due, in part, to the use of incorrect supply costs for 
venom extracts that we priced at $5.18 per ml. The commenters provided 
documentation of current prices of five different venoms from two of 
the largest manufacturers of venom extracts. They proposed a price-
averaging methodology utilizing the small and large quantities of 
venoms that are available from the two suppliers. A price of $12.22 per 
milliliter of venom antigen results from using this methodology, and 
the commenters suggest that this price be used in valuing four of the 
five CPT Codes for venom immunology, with the exception of CPT Code 
95147. When a patient requires three stinging insect venoms, as for CPT 
95147, the commenters believe the 3-Vespid mix is typically used. 
Again, the commenters suggested the same price-averaging method noted 
above using cost information from the two vendors, which results in a 
price of $23.49 per ml. This 3-vespid mix price could also be used to 
value CPT Codes 95148 (four venoms) and 96149 (five venoms) with the 
single venom, priced at $12.22, added once to CPT code 97148 and twice 
to CPT Code 97149.
    Response: We were pleased to receive the comments, as well as the 
requested documentation, on the price for various venom extracts, 
because the venom pricing information was not included in the PEAC 
recommendations forwarded after the September 2002 meeting for these 
CPT Codes. This lack of data necessitated the use of a generic stinging 
insect venom price of $5.18 per ml. We accept the pricing information 
supplied by these specialty societies, although we do not agree with 
their proposed averaging of prices from both the small (5ml and 6ml) 
and larger (10ml and 12ml) quantities of venoms. We believe it is more 
appropriate to average the venom prices using the larger (10ml and 
12ml) quantities because of the volume that is used in an accepted 
venom immunotherapy program, which consists of a build up period of 
about four months followed by monthly maintenance therapy. The 
following prices result from this approach: $10.70 per ml of venom and 
$21.26 for the 3-Vespid Mix. Venom pricing for the five CPT codes would 
be as follows: CPT Code 95145 (one venom) at $10.70, CPT Code 95146 
(two venoms) at $21.40, 95147 (three venoms using 3-vespid mix), would 
be $21.26; CPT Code 97148 (four venoms), $21.26 + $10.70 = $31.96; and 
the venom antigen price for

[[Page 63207]]

CPT Code 97149 (five venoms) would be $42.66 ($21.26 + $10.70 + 
$10.70).
    Comment: JCAAI also supplied pricing information for the multi-tine 
device that was requested in Table 1 of our proposed rule. As was 
suggested above, the commenters again proposed we average costs for 
high and low volume purchases, excluding bulk pricing, to obtain the 
price for each test.
    Response: We appreciate the pricing information forwarded by JCAAI 
and selected a purchase quantity that is in the middle of the suggested 
range. For percutaneous allergy testing, CPT code 95004. This purchase 
quantity represents testing 200 typical patients, each receiving 40 
tests. We have added this Multi-tine per test price, $0.233,to the CPEP 
database for CPT codes 95004 and 95010.
    Comment: The American Speech-Language-Hearing Association (ASHA) 
provided pricing information for the following items accompanied by the 
requested documentation: Aphasia assessment treatment forms--$2.84 (for 
a diagnostic aphasia examination form and aphasia diagnostic profile), 
communication books/treatment notebook--$1.50 and eartip insert--$0.65 
each or $0.39 each (two sources). The American Academy of 
Otolaryngology--Head and Neck Surgery (AAO-HNS) submitted a price for 
the eartip insert of $0.23 each and suggested that the communication 
books/treatment notebook be deleted. The (AAO-HNS)also submitted a 
price for cottonoids at $0.875 each and for the phenol applicator kit 
at $15.95 each.
    Response: We will use the submitted price for the aphasia forms and 
will price the eartip insert at $0.423, which is the average of the 
three prices submitted. The notebook, which is assigned to the speech-
language therapy code, would be used over a course of treatment, and is 
not a disposable supply that is used or priced for a single service. 
Therefore, we will delete this item from our CPEP supply data. For the 
phenol applicator kit, we will use the price of $15.152 per kit that 
represents an average price for a 6-kit and a 24-kit quantity purchase. 
Because these kits contain the phenol that is used in the procedures, 
phenol has been deleted as a separate supply from the 11 CPT codes that 
are assigned the kit. AAO-HNS used a 10-pack quantity to assign a price 
to each cottonoid, but we are using a 200-pack quantity that reflects 
the high usage of this item. Therefore, we are using $0.773 as the 
price for each cottonoid.
    Comment: Specialty societies representing radiation oncology and 
radiology disagreed that the fiducial screws used with the intensity 
modulated radiation therapy procedure should be deleted from the CPEP 
input supply list. The society argued that the screws are typically 
used for this procedure and that they are not separately billable.
    Response: We will retain the fiducial screws in the list of 
supplies assigned to the intensity modulated radiation therapy 
procedure.
    Comment: The American Society of Colon and Rectal Surgeons offered 
description changes for two services, CPT codes 46917 and 46924. The 
society recommended that the descriptor for the laser tip for both 
codes be changed to ``laser tip, bare (single use)'' at $150. The 
commenter also requested that an ablation laser generator at $59,890 be 
added to both codes and the existing laser, diode laser, and laser 
generator be deleted.
    Response: A note from our contractor who is working on our 
repricing effort verified the above changes and we have revised our 
supply and equipment databases to reflect them.
    Comment: The American Association of Orthopaedic Surgeons agreed 
with the proposed supply deletions listed in Table 1 of the proposed 
rule that are used in orthopaedic surgery. In addition, the association 
agreed with the concept of standardization of unit descriptions. 
However, the comment contends that the term ``unit of use (uou)'' is 
unclear and that we should consider alternative terms and abbreviations 
that would be more intuitive.
    Response: The supply items in Table 1 that were listed for 
orthopaedic surgery are broach kit, hallux implant, sterile hand table 
drape, sterile cuff tourniquet, cephalosporin and sterile ankle 
tourniquet. As stated above, we will be deleting the broach kit and 
hallux implant and will also delete the hand table drape, cuff 
tourniquet and cephalosporin. As also noted above, we will retain the 
sterile ankle tourniquet in the supply database because the comment 
from the podiatry society argued that this item was not typically 
reused.
    With regard to the comment on the use of ``unit of use,'' we 
selected the ``unit of use'' (uou) term to indicate any item that is 
packaged for single use, even if the item is not completely used up. 
This most often occurs with items that are packaged sterile. For 
example, ``bacitracin (0.9gm uou)'' refers to one 0.9gm foil package. 
The quantity entered would be 1 and not a smaller amount such as 0.3. 
Once this foil package is broken, it is considered ``used up'' and 
therefore the unit of use is 0.9gm. Specifically, any item with a 
``unit of use'' designation is meant to be indicated in whole number 
``unit of use'' quantities, not partials (e.g., entered as 1, 2, 3, 
etc, and not 0.5, 1.5, etc.).
    Comment: A commenter representing sleep medicine stated that our 
proposed price of $25 is significantly below prices for standard CPAP 
masks used in the polysomnography service, CPT code 95811. The 
commenter submitted prices from two manufacturers that average to $88.
    Response: It appears that the commenter has submitted prices for a 
reusable CPAP mask that would not be included in our CPEP data as a 
disposable supply. Therefore, we will price the disposable mask at 
$25.135, as proposed.
    Comment: We received a comment from the American Physical Therapy 
Association (APTA) that contended there is a rank order anomaly caused 
by the increased price for the electrode used for CPT code 97033, 
iontophoresis. APTA noted that the price of a ``pair'' of electrodes 
was $16 in 2001 but has increased to $23.98 under our current supply 
repricing initiative. APTA has asked that we review the proposed cost 
of this item as a means to moderate the rank order anomaly.
    Response: We appreciate the comments offered by APTA and have 
reviewed the cost of the supplies assigned to the iontophoresis 
service. We determined that the electrodes for this service are 
packaged and priced as ``kits'' that contain the complete set of 
electrodes needed to provide one iontophoresis treatment. Therefore, 
only one electrode ``kit'' is needed for this code, as opposed to the 
two electrode ``pairs'' currently in our supply database. Consequently, 
we have changed the supply list for iontophoresis in our database to 
reflect that there is one kit, not two electrodes, at the proposed 
price of $11.99. We believe that this should correct the rank order 
anomaly.
    The following table, ``Table 1 Items Needing Specialty Input,'' 
lists those items on which we had requested specialty input, comments 
we received and the actions we are taking.

[[Page 63208]]



                                                         Table 1.--Items Needing Specialty Input
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           2003 PE                           Prior status of
    2003 PE supply description         2003 PE unit         price     Primary specialties      supply item       Commenter response    CMS action taken
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetylcholine 10%................  1 gram..............        $0.40  Nurse practitioner,  See Note C. Need     None...............  See Note D.
                                                                       neurology.           patient-use item,
                                                                                            not R&D item.
Aerochamber......................  1 item..............  ...........  Cardiology,          Item may be          Agree--reusable.     Disagree--Deleted.
                                                                       internal medicine.   deleted. May not     Requests item be
                                                                                            be typical and may   retained.
                                                                                            be separately
                                                                                            billable.
Albuterol........................  1 ampule............  ...........  Family practice,     See Note B.........  Agree--separately    Deleted
                                                                       internal medicine.                        billable.
Anthralin ointment...............  1 g.................         2.75  Dermatology........  See Note C.........  None...............  See Note D.
Aphasia assessment--forms average  1 item..............         0.95  Psychiatry,          See Note C.........  Pricing information  Retained at
                                                                       neurology.                                submitted at $2.84.  submitted price.
Balloon, achalasia...............  1 item..............       255.00  General surgery,     See Note C. (Codes   NA in non-facility.  Deleted.
                                                                       colon and rectal     utilizing this
                                                                       surgery.             item being
                                                                                            reviewed by CPT).
Blood dress package..............  1 item..............  ...........  Neurosurgery.......  Item may be          None...............  Deleted.
                                                                                            deleted. Gowning
                                                                                            items listed
                                                                                            separately.
Broach kit.......................  1 item..............  ...........  Podiatry,            See Note A.........  Agree--separately    Deleted.
                                                                       orthopaedic                               billable and
                                                                       surgery.                                  reusable.
Cable for EMG needle electrode...  1 item..............         1.20  Neurology, PM&R....  See Note A.........  None...............  Deleted.
Centimeter ruler.................  1 each..............         2.39  Radiation oncology,  See Note A.........  None...............  Deleted.
                                                                       dermatology.
Cephalosporin....................  1 gm................  ...........  Podiatry,            See Note B.........  Agree--separately    Deleted
                                                                       orthopedic surgery.                       billable.
Chordae Villae sampling kit......  1 item..............  ...........  Obstetrics,          Item may be          None...............  Deleted.
                                                                       gynecology.          deleted.
                                                                                            Duplicated item
                                                                                            with catheter-
                                                                                            stylet kit.
Collagen kit.....................  1 each..............      1383.00  Urology............  Need kit contents.   NA in non-facility.  Deleted.
                                                                                            Collagen sold as
                                                                                            individual
                                                                                            syringe. No
                                                                                            commercial kit
                                                                                            available.
Communication book/Treatment       1 each..............  ...........  Otolaryngology,      See Note C.........  Audiology priced at  Deleted--reusable.
 notebooks.                                                            audiology.                                $1.50 or $3.50.
                                                                                                                 ENT proposed to
                                                                                                                 delete.
Cottonoids.......................  1 item..............  ...........  Otolaryngology.....  See Note C.........  Submitted price of   Retained at $0.73.
                                                                                                                 $0.875.
CPAP nasal pillow................  1 each..............  ...........  Pulmonary medicine.  Item may be          Agree--not typical.  Deleted.
                                                                                            deleted.
                                                                                            Disposable CPAP
                                                                                            face mask also
                                                                                            included in code
                                                                                            95811. Nasal
                                                                                            pillows used with
                                                                                            reusable mask.
Cysto-catheter kit...............  1 item..............         9.04  Urology, general     Need kit contents    None...............  Deleted.
                                                                       practice.            and source/pricing
                                                                                            information.
Detection kit....................  1 slide.............         8.50  Pathology,           See Note C.........  None...............  See Note D.
                                                                       neurology.
Developmental testing--forms       1 item..............         2.64  Clinical             See Note C.          Submitted price of   Retained at
 average.                                                              psychologist,        (Original item       $0.40 for 96110      submitted prices.
                                                                       multiple other       price estimated by   and $2.44 for
                                                                       specialties.         CPEP member.).       96111.
Eartip insert with sound tube....  1 item..............  ...........  Otolaryngology,      See Note C.........  Pricing information  Retained at $0.423.
                                                                       audiology.                                submitted by two
                                                                                                                 specialties.
EEG electrode, gold DIN..........  1 item..............         0.07  Neurology..........  See Note A.........  None...............  See Note E.
Electrode, ring..................  1 item..............       475.00  Obstetrics,          See Note A.........  None...............  Deleted.
                                                                       gynecology,
                                                                       urology.

[[Page 63209]]


Electrodes, pickup, black tin,     1 item..............         0.42  Podiatry, neurology  See Note A.........  None...............  See Note E.
 9mm.
Electrodes, pickup, red tin, 9mm.  1 item..............         0.42  Podiatry, neurology  See Note A.........  None...............  See Note E.
Fiducial screws, set of 4........  1 set...............       558.00  Radiation oncology.  Item may be          Disagree--not        Agree--Retained.
                                                                                            deleted. May not     separately
                                                                                            be typical and may   billable.
                                                                                            be separately        Specialty requests
                                                                                            billable. (Screws    item be retained.
                                                                                            used for IMRT head
                                                                                            fixation device,
                                                                                            but typical
                                                                                            patient vignette
                                                                                            is prostate
                                                                                            cancer.).
Film, fluoroscopic...............  1 sheet.............         3.51  Diagnostic           See Note C.........  None...............  See Note D.
                                                                       radiology,
                                                                       anesthesia.
Flow sensors.....................  1 item..............         1.51  Pulmonary medicine,  See Note A.........  Agree--reusable....  Deleted.
                                                                       internal medicine.
Gold-palladium target............  1 item..............         0.59  Pathology..........  See Note A.........  None...............  Deleted.
Hallux implant...................  1 item..............  ...........  Podiatry,            See Note B.........  Agree--separately    Deleted.
                                                                       orthopaedic                               billable.
                                                                       surgery.
Headcover for MRI................  1 item..............         0.05  Diagnostic           See Note C.........  None...............  See Note D.
                                                                       radiology.
Inhalant.........................  1 ml................         0.75  Cardiology,          Item may be deleted  Use is typical.....  Retained at $0.788.
                                                                       internal medicine.   (May not be
                                                                                            ``typical'' for
                                                                                            service.).
Laryngeal mirror.................  1 item..............  ...........  Diagnostic           See Note A.........  None...............  Deleted.
                                                                       radiology,
                                                                       otolaryngology.
Laser fiber......................  1 item..............       595.00  Urology............  See Note A.........  Disagree--not        Agree--retained at
                                                                                                                 reusable.            submitted price.
                                                                                                                 Submitted price of
                                                                                                                 $850.
Laser fiber cleaving tool........  1 item..............       200.00  Urology............  See Note A.........  None...............  Deleted.
Methylcholine chloride...........  1 dose..............        48.50  Pulmonary medicine,  See Note B.........  Disagree--not        Agree--Retained at
                                                                       internal medicine.                        separately           $39.95.
                                                                                                                 billable. Requests
                                                                                                                 item be retained.
Mounting tray....................  1 each..............        40.00  Radiation oncology,  See Note A.........  None...............  Deleted.
                                                                       diagnostic
                                                                       radiology.
Multi-tine device................  1 item..............  ...........  Allergy/immunology.  See Note C.........  Submitted pricing    Retained at $0.23.
                                                                                                                 information.
Needle, 4 inch...................  1 item..............  ...........  Obstetrics,          See Note C.........  None...............  Deleted.
                                                                       gynecology.
Needle, 4-6 inch.................  1 item..............  ...........  Obstetrics,          See Note C.........  None...............  Deleted.
                                                                       gynecology.
Needle, seldinger................  1 item..............        72.90  Diagnostic           See Note A.........  Disagree--not        Agree--Retained.
                                                                       radiology,                                reusable.
                                                                       multiple other
                                                                       specialties.
Neurobehavioral status--forms      1 item..............         5.77  Clinical             See Note C.          None...............  See Note D.
 average.                                                              psychologist,        (Original item
                                                                       multiple other       price estimated by
                                                                       specialites.         CPEP member.).
Oximetry sensor probe............  1 item..............        15.00  Multiple             See Note A.........  Agree--resuable....  Deleted.
                                                                       specialties.
Penile clamp.....................  1 item..............        40.70  Urology............  See Note A.........  None...............  Deleted.
Phenol applicator kit............  1 unit..............  ...........  Otolaryngology.....  See Note C.........  Pricing information  Retained at
                                                                                                                 submitted.           $15.152.
Primary antibodies...............  1 slide.............         3.52  Pathology,           See Note C.........  None...............  See Note D.
                                                                       neurology.
Psych testing--forms average.....  1 item..............         2.30  Clinical             See Note C.........  None...............  See Note D.
                                                                       psychologist.
Receive coil.....................  ....................  ...........  Diagnostic           See Note A.........  None...............  Deleted.
                                                                       radiology.
Ruler............................  1 each..............         2.67  Radiation oncology,  See Note A.........  None...............  Deleted.
                                                                       diagnostic
                                                                       radiology.
Scissors and clamp, disposable...  1 each..............         0.62  Radiation oncology,  Need clamp           None...............  See Note D.
                                                                       diagnostic           description and
                                                                       radiology.           source/pricing.

[[Page 63210]]


Sealant spray....................  ....................  ...........  Radiation oncology,  See Note C.........  None...............  See Note D.
                                                                       diagnostic.
Silverman needle.................  1 item..............        66.35  Urology............  See Note A.........  None...............  Deleted.
Skin prep, one step..............  1 item..............        26.00  Cardiology.........  Need inches used     None...............  See Note D.
                                                                                            per procedure
                                                                                            (196in per roll).
Smoke evacuation cartridge.......  1 item..............       146.50  Obstetrics,          See Note A.........  None...............  Deleted.
                                                                       gynecology.
Sterile, hand table drape (24x43)  ....................  ...........  Orthopaedic          Item Deleted.        Agree..............  Deleted.
                                                                       surgery, hand        Integral part of
                                                                       surgery.             hand/upper
                                                                                            extremity drape
                                                                                            supply item.
Sterilizing tray.................  1 each..............        64.00  Radiation oncology,  See Note A.........  None...............  Deleted.
                                                                       diagnostic
                                                                       radiology.
Steroid..........................  1 cc................         1.29  Urology............  See Note B.........  None...............  Deleted.
Sweat cells, 4 in a set..........  1 set...............       260.00  Neurology..........  See Note A.........  None...............  Deleted.
Thrombectomy device..............  1 item..............       600.00  Diagnostic           Additional           Disagree--device is  Agree--Retained.
                                                                       radiology.           information          not reusable.
                                                                                            required. Device
                                                                                            is reusable. Need
                                                                                            to identify
                                                                                            specific PTD
                                                                                            single-use
                                                                                            accessories (e.g.
                                                                                            sheath rotator
                                                                                            drive basket).
Tourniquet, ankle, sterile.......  1 item..............  ...........  Podiatry,            See Note A.........  Disagree--packaged   Agree--retained at
                                                                       orthopaedic                               for single use.      submitted price.
                                                                       surgery.                                  Price submitted at
                                                                                                                 $42.87.
Tourniquet, cuff sterile.........  ....................  ...........  Orthopaedic          See Note A.........  Agree..............  Deleted.
                                                                       surgery, hand
                                                                       surgery.
Traction straps..................  1 item..............        60.00  Radiation oncology,  See Note A.........  None...............  Deleted.
                                                                       diagnostic
                                                                       radiology.
Transtelephonic monitor..........  ....................        10.56  Cardiology.........  See Note A.........  Agree--resuable,     Disagree--Deleted.
                                                                                                                 but requests item
                                                                                                                 be retained.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* CPT codes/descriptions only are copyright 2003 American Medical Assn. All Rights Reserved. Applicable FARS/DFARS apply.
Notes:
A. Item deleted. Reusable
B. Item deleted. Separately Billable
C. Additional information required.
D. Issue is pending. Still under review.
E. Issue is pending. Reuse discussion needed.

h. Miscellaneous Practice Expense Issues

Hyperbaric Oxygen Services
    We proposed to assign, on an interim basis, the following practice 
expense inputs to CPT code 99183, Physician attendance and supervision 
of hyperbaric oxygen therapy, per session, when performed in the office 
setting:
    Staff: Respiratory Therapist for 135 minutes (for a 2 hour 
treatment); Supplies: Minimum Visit Supply Package, 180 liters of 
oxygen, 187 cubic feet of air; Equipment: Hyperbaric chamber.
    Comment: A freestanding hyperbaric oxygen center expressed 
appreciation that we priced this procedure in the non-facility setting. 
The commenter also requested that we add certain staff time and some 
supplies to the practice expense inputs assigned to this service.
    The additional supplies requested include disinfectant for cleaning 
the hyperbaric chamber after each patient, two otoscope covers to check 
patients' ears pre and post treatment, and a denture cup and urinal. An 
additional 24 minutes of clinical staff time (using the standard staff 
blend) was also requested for preparing the room, greeting and gowning 
the patient, patient education, taking vital signs before and after 
treatment, positioning the patient and cleaning the room.
    Response: We believe that the request for the above additional 
practice expense inputs is reasonable. Currently, we have assigned 
clinical staff time only for assisting during the procedure itself; 
additional time was calculated using the times used by the PEAC for the 
tasks listed. Therefore, we are adding these inputs to those already 
assigned to the hyperbaric oxygen service. We have also requesting that 
the PEAC review these inputs at a future meeting and the RUC has stated 
that the PEAC will be reviewing this CPT code at the January or March 
2004 meeting.
    Comment: A commenter from another freestanding hyperbaric center 
expressed concern that the proposed physician fee schedule payment for 
CPT 99183 is approximately 25 percent of the payment in the hospital 
setting. The commenter lists additional costs that

[[Page 63211]]

should be considered such as special cleaners and solvents for cleaning 
the chamber, the costs of adherence to quality standards and costs for 
laundering patients' clothing, sheets and blankets. The commenter also 
stated that the hyperbaric chamber costs more than the $125,000 we have 
assigned the item.
    Response: As mentioned above, we have added disinfectant solution 
for cleaning the chamber. We will be proposing the repricing of all 
equipment in our CPEP database next year, which should ensure that the 
price for the hyperbaric chamber reflects the typical cost. The cost of 
laundering and much of the quality assurance costs are considered 
indirect and are not reflected in our direct cost database. However, if 
the PEAC does refine this code as planned, we will review any 
recommendation submitted.

Maxillofacial Prosthetics PE/hour

    We proposed to eliminate the special practice expense pool for 
maxillofacial prosthetic services and to use otolaryngology as the 
crosswalk for oral surgeons and maxillofacial surgeons as a more 
appropriate approximation of the specialties' practice expense per 
hour.
    Comment: The American Association of Oral and Maxillofacial 
Surgeons expressed appreciation for our work on this issue over the 
past three years and heartily concurred with the decision to crosswalk 
maxillofacial prosthetics to otolaryngology. The American Academy of 
Otolaryngology-Head and Neck Surgery also supported our proposed 
crosswalk.
    Response: We will implement the crosswalk of maxillofacial 
prosthetics to otolaryngology as proposed.

Holter Monitoring Codes

    We proposed revising the practice expense inputs for holter 
monitoring codes to remove items that were not needed to perform the 
services. Specifically, we proposed deleting the ECG electrodes and 
laser paper, as well as the electric bed, computer and holter monitor 
from CPT codes 93225 and 93231 and deleting the razor, nonsterile 
gloves, alcohol swab and tape, as well as the electric bed and exam 
table from CPT codes 93226 and 93232.
    Comment: A commenter representing an independent diagnostic testing 
facility and another representing cardiologists expressed support for 
the proposed revisions to the holter monitor codes.
    We also received a comment from the RUC stating that the direct 
practice expense inputs for these above holter monitoring services will 
be reviewed by the PEAC at the January 2004 meeting.
    Response: We will make the proposed changes to the holter 
monitoring codes on an interim basis and will be glad to review the 
recommendations from the PEAC when we receive them next year.

Other Practice Expense Issues

    Comment: We have received requests from several commenters that we 
value certain procedures currently priced only in the facility setting 
in the non-facility setting as well. A manufacturer commented that 
there is a need to price the hysteroscopic endometrial ablation 
procedure, CPT code 58563, in the office to ensure Medicare patient 
access to this alternative to hysterectomy in the least intrusive and 
least costly setting. Several individual gynecologists have expressed 
concern about the absence of a nonfacility rate for this service 
because the facility payment does not cover the costs of performing 
this procedure in the office.
    A manufacturer of endoscopic and surgical supplies and equipment 
expressed concern that several urology services which had previously 
been priced in the non-facility setting, are no longer priced in that 
setting. The commenter contended that the procedures can be performed 
safely in the office and that patients will be forced to go to a 
hospital or ambulatory surgical center for these procedures if the 
office payment does not reflect the direct costs incurred by the 
physician. The services in question are three cystourethroscopy 
procedures, CPT codes 52224, 52275, 52276, and two destruction of 
penile lesion procedures, CPT codes 54057 and 54065.
    A consultant representing non-hospital based providers of LDL 
apheresis, CPT code 36516, requested that we price this procedure in 
the nonfacility setting and provided some cost data for this code. The 
commenter stated that this procedure is commonly provided outside of 
hospitals. A medical technology company requested that we price the 
percutaneous implantation of neurostimulator electrodes procedure, CPT 
code 64561, in the nonfacility setting. This service had previously 
been priced in the office.
    Response: We are aware that technological advances make it now 
possible for more procedures to be safely performed in a physician's 
office. However, CPT code 58563 has recently been reviewed by the PEAC, 
and neither the gynecology specialty society nor the PEAC recommended 
pricing this code in the office setting. Likewise, the urology 
procedures and the neurostimulator service were reviewed this year by 
the PEAC and the apheresis services last year by the RUC, and the PEAC 
and the RUC recommended that these services not be priced in the office 
setting based on the presentation made by the specialty societies. We 
would not rule out working further with the commenters on these 
requests, but we believe that it would not be appropriate to take such 
an action in this final rule. We will be willing to discuss this issue 
further to determine whether any action should be proposed in the 
future.
    Comment: The RUC comment identified the following anomalies in the 
CPEP database for the clinical staff time for a few codes with 000 day 
global periods:
B. (1) Percutaneous Abscess Drainage Codes
    In 1997, CPT created new codes to differentiate between open and 
percutaneous abscess drainage. Unlike their open procedure 
counterparts, all of the percutaneous codes were assigned a global 
period of 000 days with no follow-up visits assigned. However, CMS 
crosswalked the direct inputs from the open codes, which have a 
different global period, to the percutaneous codes, including the time 
assigned for post-procedure office visits. The percutaneous abscess 
drainage codes identified are CPT codes 32201, 44901, 47011, 48511, 
49021, 49041, 49061, 50021, 58823. The comment stated that each of 
these codes is currently priced in the facility setting only. Because 
these procedures are predominately performed in the inpatient setting, 
the comment further recommended that we assign zero direct practice 
expense inputs for these codes.
(2) Closure of Eyelid by Suture
    The commenter also pointed out that CPT code 67875, Closure of 
eyelid by suture, has an assigned global period of 000 and includes no 
post-procedure visits in the work relative value. However, the original 
CPEP process appears to have assigned the code clinical staff time, 
supplies, and equipment related to a follow up visit.
    Response: We agree with the RUC that these 0-day global codes 
should not have any direct costs assigned for post-procedure follow up 
visits. Therefore, we are deleting from the database all the inputs 
related to such visits.
    Comment: Several commenters have expressed concern with the 
unexplained reduction in nonfacility practice expense RVUs for HCPCS 
code G0166, External counterpulsation.
    Response: We have examined the practice expense data files and have

[[Page 63212]]

discovered an error in the database. This has now been corrected.
    Comment: A specialty society representing dermatology commented 
that the practice expense RVUS for laser treatment of psoriasis 
procedures, CPT codes 96920-96922, appear overvalued.
    Response: The practice expense has increased for these codes 
because we did not have a price for the laser tip used in these 
procedures until this year. The laser tip is now priced at $240. We 
have made adjustments to ensure the practice expense RVUs reflect the 
correct pricing of supplies as well as the specialty performing the 
service.
    Comment: One specialty society that represents gastroenterologists 
commented that we cut the payment rate for the colonoscopy procedure, 
CPT 45385, by 10 percent in the nonfacility setting without explanation 
or justification.
    Response: The decrease in payment for this code is due to the 
decreased practice expense inputs now assigned to the service. The PEAC 
submitted recommendations for the direct practice expense inputs for 
this service that were based on a presentation made by two other 
gastroenterological specialty societies, and we have accepted these 
recommendations because we believe them to be reasonable. The code was 
included on Addendum C, ``Codes for Which We Received PEAC 
Recommendation on Practice Expense Direct Cost Inputs,'' in the 
proposed rule.
    Comment: Several commenters representing pediatricians, family 
physicians and chest physicians stated their concern with the proposed 
decrease in the practice expense RVUs for immunization services, CPT 
codes 90471 and 90472, which were removed from the non-physician work 
pool and priced under the top-down methodology starting in 2003.
    Response: We will return the two immunization services to the 
nonphysician work pool. As discussed above, we are increasing the price 
assigned to the needle stick prevention device that is in the supply 
list for the immunization codes. However, the practice expense RVUs for 
these codes would still be less than the current values. As discussed 
above, the price for the needle stick prevention device is still 
fluctuating as new manufacturers enter the market. In addition, it is 
still not clear exactly which device is optimal for the protection of 
medical staff. Therefore, until these issues are settled, we will price 
these immunization services in the nonphysician work pool. This will 
prevent any sharp decrease in payment for these codes, as well as for 
payments for the HCPCS G-codes for administration of influenza, 
hepatitis and pneumococcal vaccines, which are crosswalked to the 
payment for CPT code 90471.
    Comment: We received a comment from Venable, a diathermy 
manufacturer, who voiced concerns about previous decreases in both the 
work and the practice expense RVUs for the diathermy procedure, CPT 
code 97024. According to the commenter, the PEAC recommendations we 
accepted for 2002 included a substantial reduction in clinical labor 
time, the elimination of supplies, and the undervaluing of the 
diathermy equipment, including the assignment of inadequate time for 
equipment use. Citing our current CPEP price of $3,120 as too low, the 
commenter noted the cost of the diathermy machines they manufacture 
range from $19,000 to $30,000 and noted the actual time of a typical 
treatment is 20 minutes, and not 15, as currently listed. A previous 
comment from the electrophysiology specialty section of the American 
Physical Therapy Association (APTA) stated that the average cost of 
diathermy ranges between $10,000 and $15,000.
    Response: We believe the practice expense recommendation we 
accepted from the PEAC in 2001 for the clinical labor and supplies is 
appropriate. We would note here that the resultant PEAC recommendation 
for clinical labor was just one minute less than that proposed by the 
American Physical Therapy Association at the 2001 PEAC meeting. We 
continue to support the PEAC's decision to eliminate the supplies for 
some of the modality procedures, including diathermy, since these 
services are typically performed with other therapy procedures where 
the supply costs are captured. However, we agree with the commenter 
that the current pricing of the diathermy equipment in our CPEP 
database appears too low, and we will price the diathermy, on an 
interim basis, at $10,000 for the 2004 fee schedule. In addition, we 
will assign the requested 20 minutes as the typical time the diathermy 
equipment is in use for each service. We are planning to propose a 
repricing of all of the equipment included in our database next year 
and will revisit the pricing of the diathermy equipment at that time.
    In response to the commenter's work RVU concern, next year's final 
rule will solicit recommendations of codes to be considered for review 
under the five-year review of work that is to occur in 2005.
    Comment: A commenter representing prosthetic urology focused on 
reductions in payment for several 90-day global prosthetic urology 
procedures. The commenter contended that these procedures were affected 
by the adoption of the standard clinical staff times for 90-day global 
procedures that did not reflect the extra staff time required for 
patient training during post-procedure visits. In addition, almost half 
of the prosthetic urology services were established in 2002 and this 
appeared to have a negative effect on these codes. The commenter 
strongly recommended that the standard clinical staff times not be 
applied to the prosthetic urology codes and that we reinstate the 
``benchmark'' clinical staff times.
    Response: The commenter is correct that the major cause of the 
decrease in practice expense RVUs for these services is the use of the 
standard clinical staff time for 90-day global services. We do not have 
``benchmark'' clinical staff times to reinstate for any of these 
services. Rather, the current staff times are from the original CPEP 
panel estimates that have not been reviewed by any multi-specialty 
panel, such as the PEAC. We accepted the PEAC recommendation to apply 
the standard clinical staff time to all 90-day global services that had 
not been reviewed by the PEAC as having exceptions to the standard 
times. All specialties, including urology, had ample opportunity to 
present any codes for which they believed the standards did not apply; 
these urology codes were not brought to the PEAC for review. We do not 
believe we have a sufficient factual basis for changing the clinical 
staff times for these services in this final rule. However, we would 
consider any recommendations for revising the pre- and post-service 
clinical staff times in the future. As to the effect of using the most 
recent utilization data in calculating the practice expense RVUs for 
the new prosthetic urology services, please see the discussion on 
``Utilization Data'' earlier in this section.
    Comment: A specialty society representing emergency medicine, an 
emergency medicine practice management association and an emergency 
medicine physician practice management organization all commented that 
the adjustment made in the November 2, 1998 final rule (63 FR 58821) to 
use the ``all physician'' practice expense per hour to calculate two 
indirect cost pools does not make up for the uncompensated care costs 
of emergency medicine physicians. The practice management association 
questioned our previous claim that this

[[Page 63213]]

adjustment was made as a proxy for uncompensated care and asserted it 
was rather a generic measure to address the low practice expense per 
hour for emergency medicine. The specialty society commented that it 
would be difficult to design a supplementary survey to capture the 
needed data on the levels of uncompensated care.
    Response: It is amply clear from reading our entire response in the 
November 2, 1998 final rule that we considered the adjustment to the 
indirect costs to serve as a proxy for the uncompensated care 
experienced by emergency medicine physicians. We believe that, if this 
adjustment is seen by the specialty as insufficient, the best recourse 
is for the specialty to undertake a supplementary practice expense 
survey. By working with our contractor, the Lewin Group, the specialty 
society should be able to modify the survey in such a way that more 
accurate data on uncompensated care could be obtained. The data from 
such a survey could then take the place of the current adjustment to 
the practice expense per hour for emergency medicine because a proxy 
for uncompensated care would no longer be needed.
    Comment: We received comments from a provider of extracorporeal 
photopheresis therapy, CPT code 36522, requesting a refinement of the 
practice expenses of this service in the office setting. Believing this 
service to be undervalued, the commenter supplied a comprehensive 
listing of the direct inputs, for the labor, equipment and supplies 
deemed necessary for the provision of this in-office service. Of 
particular note among the various suggested supply items was the 
inclusion of a photopheresis procedural kit.
    Response: We want to thank the photopheresis provider for the 
practice expense suggestions. At this time, we do not have sufficient 
information regarding the typical resources needed to proceed with a 
comprehensive refinement of the practice expenses for the in-office 
provision of photopheresis. However, in reviewing the commenter's 
various practice expense proposals, we were struck by the obvious 
absence of the photopheresis procedural kit in our supply database. 
Consequently, this kit has been added to our CPEP database on an 
interim basis. We note that there are general similarities between the 
commenter's proposed inputs for clinical labor and equipment and our 
current data. We would anticipate a future discussion regarding this 
service in order to fully refine the practice expense direct cost 
inputs for photopheresis.

B. Geographic Practice Cost Index Changes

1. Background
    The Act requires that payments vary among Medicare physician fee 
schedule (MPFS) areas according to the extent that resource costs vary, 
as measured by the Geographic Practice Cost Indices (GPCIs). Section 
1848(e)(1)(C) of the Act requires us to review, and, if necessary, 
adjust the GPCIs at least every 3 years. This section of the Act also 
requires us to phase in the adjustment and implement only \1/2\ of any 
adjustment if more than 1 year has elapsed since the last GPCI 
revision. The GPCIs were first implemented in 1992. The first review 
and revision was implemented in 1995, the second review was implemented 
in 1998, and the third review was implemented in 2001. As explained in 
the August 15, 2003 proposed rule, the fourth GPCI review and revision 
was scheduled for implementation in 2004. However, because the work and 
practice expense GPCIs rely primarily on special tabulations of U.S. 
Census data not yet available, review and revision of only the 
malpractice GPCI component would occur for implementation in January 
2004.
2. Malpractice GPCI Proposal
    The malpractice GPCI is the most volatile of the three indices with 
relatively large variations existing between geographic payment 
localities. We proposed using actual 1999 through 2002 malpractice 
premium data and forecasting the malpractice premium rates for 2003. We 
were unable to include proposed malpractice GPCIs based upon this 
revised malpractice premium data in the August 15, 2003 proposed rule 
because we were still in the process of collecting the data. We stated 
that the revised malpractice GPCIs published in this year's final 
physician fee schedule regulation would be considered interim and 
subject to public comment.
3. Collection and Review of Malpractice Premium Data
    For purposes of the 2004 update to the malpractice GPCIs we 
collected actual malpractice premium data for years 1999 through 2001. 
For 2002 we were able to obtain actual malpractice premium data for 32 
states plus Puerto Rico. Where actual malpractice premium data were 
obtained, premiums were collected from the 20 physician specialties 
with the largest share of total Medicare RVUs for 2002. Premiums were 
collected from those insurers with the largest market share and those 
insurers that when summed with other large insurers comprised at least 
50 percent of the state market share for claims-made policies with a $1 
million individual case limit and $3 million aggregate case limit.
    For those 18 states plus the District of Columbia for which we were 
unable to obtain actual 2002 premium data, we estimated the 2002 
premium based upon an examination of growth rates from 1999 to 2001.
    Malpractice premium data were not available for 2003. Two 
statistical approaches were examined to forecast 2003 malpractice 
premiums, simple extrapolation and projections based upon the average 
of historical year-to-year changes (mean rate of change). In most 
instances, the forecast 2003 premiums were similar using either 
approach. There was a tendency for the linear extrapolation method to 
yield slightly more extreme values (positive and negative) so the more 
conservative, mean rate of change approach was chosen.
    Comment: Several commenters expressed concern about the continued 
use of proxy data, especially HUD residential rent data and 
nonphysician professional wage data, in the GPCI methodology.
    Response: This final rule does not update the work or practice 
expense GPCIs. Any questions related to the use of proxy data in the 
calculation of the work and practice expense GPCIs will be responded to 
as part of future rulemaking.
    Comment: One commenter stated that there should be no geographic 
differences under the physician fee schedule. This commenter felt that 
the data sources utilized for the construction of the locality specific 
GPCI indices do not accurately reflect legitimate differences in 
physician practice costs and that the current methodology did not 
appropriately reflect the variation that might be caused by case mix, 
availability of health care resources, and individual practice styles.
    Response: Section 1848(e)(1)(A) of the Act requires that payments 
vary among areas as resources costs vary as reflected by the GPCIs. We 
agree that there will be some variation in case mix and practice styles 
between different specialties and individual practitioners. The 
physician fee schedule was established in 1992 to eliminate the large 
unjustifiable payment differences that existed among services, 
specialties, and geographic areas by establishing a national uniform 
payment system that can vary only as area resource costs vary as 
measured by the GPCIs. The GPCI component weights represent the

[[Page 63214]]

average physician expense weights across all physician specialties and 
are intended to reflect the average costs across all services and 
specialties in a geographic area and not to reflect exactly the costs 
of each individual practitioner.
    Comment: One commenter stated that there should be no geographic 
payment differentials because these payment differentials operate as a 
disincentive for practitioners to practice medicine in rural areas.
    Response: Section 1848(e)(1)(A) of the Act requires that payments 
vary among areas as resources costs vary as reflected by the GPCIs. It 
should be recognized that the current methodology associated with the 
calculation of GPCIs partially benefits practitioners in rural areas. 
This is because the law requires that only one-quarter of area cost 
differences in physician work, the largest of the three fee schedule 
components, be recognized. Thus, about 40 percent of fee schedule 
payments are by statute not adjusted for area cost differences. When 
combined with the index of 1.000 for medical equipment, supplies, and 
miscellaneous (which represents about 13 percent of total physician 
resource costs) this means that there is a national fee schedule for 
about 53 percent of the average physician payment. That is, only about 
47 percent of overall physician payments are adjusted for area resource 
cost differences. In addition, 34 states have a single statewide GPCI 
wherein all physicians, whether urban or rural, are paid the same. All 
of these factors shift payments from higher cost, usually urban, areas 
to lower cost, usually rural, areas.
    Comment: One commenter felt that we should not use projected 2003 
premium data and instead should actually collect 2003 premium data.
    Response: Currently, 2003 premium data is not available. This is 
why we will utilize projected 2003 premium data in this update. We plan 
to utilize more current premium data as it becomes available.
    Comment: Although several commenters expressed their support for 
the use of more current malpractice premium data, a few commenters had 
concerns about the use of 2001 through projected 2003 premium data and 
felt that we should use only projected 2004 premium data in place of 
the three year average.
    Response: Since the malpractice index has proven to be the most 
volatile of the indices in past updates, with significant changes from 
year-to-year, we will not base the malpractice GPCI upon just one year 
of projected data. In order to protect against aberrant premiums for 
any given year, we will utilize a three-year average. We will use 2001 
through projected 2003 premium data for the three-year average.
    The current methodology projects 2003 malpractice premiums based 
upon actual malpractice premiums for 1999 through 2002. Since we will 
continue to collect updated malpractice premium data, we do not think 
it is appropriate to project through 2004 absent actual 2003 
malpractice premium data.
    Comment: One commenter suggested that due to the volatility 
associated with malpractice insurance premium data, we should collect 
premium data and re-scale the Malpractice GPCI annually.
    Response: We agree that, because malpractice insurance premiums are 
volatile, the Malpractice GPCI is also the most volatile of the three 
indices. We also agree with the commenter's suggestion regarding annual 
collection of malpractice premium data. We plan to undertake this 
collection for 2003 premium data in early 2004. If premium data suggest 
a re-scaling is warranted, we may revise the GPCIs more frequently than 
every three years.
    Comment: Several commenters requested that we make available to the 
public the malpractice premium data that was utilized in the 
calculation of the revised malpractice GPCIs.
    Response: Since some of the data upon which the GPCIs were 
constructed is based upon the reporting of individual malpractice 
insurance companies, there are some confidentiality issues associated 
with making the malpractice premium data public. We will attempt to 
make available any information that is appropriate on our Web site at 
http://www.cms.hhs.gov.
    Comment: The American Medical Association's Relative Value Update 
Committee (RUC) has requested that CMS work with the RUC's Professional 
Liability Insurance Workgroup to explore the utilization of premium 
data that might be collected by the RUC.
    Response: We agree with the RUC request and look forward to working 
with the RUC to obtain more current professional liability premium 
data.
4. Interim 2004 Malpractice GPCIs
    Acquiring data on malpractice insurance rates and using that data 
to adjust Medicare payments for future malpractice insurance prices is 
a difficult task. Malpractice insurance rates are quite volatile due to 
a variety of factors. Some of these factors are changes in State 
insurance laws, business decisions of malpractice insurance carriers, 
and changes in how medicine is practiced.
    The volatility of malpractice premium data was quite evident in the 
data we collected in conducting our review of malpractice GPCIs. Based 
on these data and the comments received on the August 15, 2003 proposed 
rule, we have modified some of our GPCI calculations and assumptions.
    We are very concerned about implementing sharp changes in 
malpractice GPCIs for 2004, which directly impact physician fee 
schedule payment amounts. At the same time, we recognize the importance 
of updating malpractice GPCIs to ensure local differences in physician 
costs are included in payment amounts. To be sensitive to both of these 
considerations, we decided to apply a modulating factor of .5 to the 
changes in the malpractice GPCIs. In other words, as part of our review 
and analysis of the malpractice GPCIs, we reduced the difference 
between the new and previous malpractice GPCIs by 50 percent.
    As directed by the statute, we will implement \1/2\ of this change 
in the first year (CY 2004) and \1/2\ of this change in the second year 
(CY 2005). During this two-year phase-in, we will continue to monitor 
local malpractice markets, work with the State Departments of 
Insurance, and collaborate with the RUC to obtain the most current and 
best malpractice premium data available. As better data are obtained, 
we will review, propose changes, and revise the malpractice GPCIs as 
appropriate. The transitional 2004 and full 2005 GPCIs can be found at 
Addendum D and Addendum E, respectively. These malpractice GPCI 
revisions necessitate a budget neutrality adjustment, as required by 
law. Therefore, we adjusted the 2004 through 2006 malpractice GPCIs by 
1.0021.
5. Payment Localities
    In the August 15, 2003 proposed rule we requested comments on the 
composition of the current 89 Medicare physician payment localities to 
which the GPCIs are applied.
    Comment: We received numerous comments from professional medical 
associations, beneficiaries, and practitioners requesting that the 
specific counties in which they practice medicine or receive medical 
care be removed from their current locality assignment.
    Response: We will continue to examine alternatives for 
reconfiguring the current locality structure. We expect to further 
consider this issue as part of future rulemaking.

[[Page 63215]]

C. Coding Issues

1. Payment Policy for CPT Tracking Codes
    The November 1, 2001 final rule (66 FR 55269) included a discussion 
of CPT Category III codes (also known as CPT tracking codes) and stated 
that carriers have discretion for coverage and payment of services 
described by these CPT tracking codes unless we have made a national 
coverage determination (NCD). We have received requests to create 
national payment amounts for some CPT tracking codes even if there has 
been no NCD. Based on these requests, we proposed to change our policy 
regarding payment for CPT tracking codes and create national payment 
policy and determine national payment amounts for CPT tracking codes 
when there is a significant programmatic need for us to do so. This 
policy change would not change the contractor's discretion over 
coverage for the CPT tracking codes, but could establish a payment 
level to be used if the contractor finds that coverage is warranted. In 
addition, carriers would not be required to establish a payment amount 
for a tracking code until they receive a claim for the code.
    Comment: Several commenters expressed concerns about this proposal. 
They believe that establishing a national payment rate for these codes 
risks premature creation of payment levels of reimbursement and creates 
an expectation for the future value of the code. The commenters also 
stated that establishment of a national price could also subvert the 
RUC process because such pricing could influence subsequent RUC 
valuation or our acceptance of the RUC's recommendations. Other 
commenters were supportive of the proposal, with some suggesting that 
we work with the specialty societies and the RUC in determining 
appropriate payment rates. One commenter suggested that an alternative 
to the proposal would be to use the existing refinement panel process 
because these refinement panels are multispecialty and feature the 
relevant specialty expertise. One commenter also requested we establish 
RVUs for specific tracking codes in the final rule.
    Response: We understand the reservations and concerns of the 
commenters. As we indicated in the proposed rule, we would determine 
national payment amounts for CPT tracking codes only when there is a 
significant programmatic need for us to do so. If there is a need to 
establish payment amounts for a tracking code, we would appreciate the 
assistance of the relevant specialty societies and the RUC and such 
pricing would be subject to public comment. However, in some instances, 
interim values might need to be established if timing does not permit 
us to obtain prior input from the medical community.

Final Decision

    We will finalize our proposal to create national payment policies 
and determine national payment amounts for CPT tracking codes when 
there is a significant programmatic need for us to do so. We note that, 
as discussed in the August 15, 2003 proposed rule, this policy change 
would not change the contractor's discretion over coverage for CPT 
tracking codes, but would establish a payment level if the contractor 
finds that coverage is warranted.
2. Excision of Benign and Malignant Lesions
    The definitions for excision of benign lesions (CPT codes 11400 
through 11446 inclusive) and excision of malignant lesions (CPT codes 
11600 through 11646 inclusive) were substantively changed for 2003. 
These codes are now reported based on the excised diameter (actual skin 
removed) rather than on the size of the lesion. Based on these changes 
to the code descriptors, we proposed to make the work RVUs the same for 
removal of all skin lesions with the same excised diameters that are 
from the same area of the body, whether the lesions are benign or 
malignant. For example, the work RVUs for the removal of benign skin 
lesions from the trunk, arms or legs with excised diameter 1.1-2.0 cm, 
CPT code 11402, would be the same as the work RVUs for CPT code 11602, 
which is the removal of malignant skin lesions from trunk, arms or legs 
with excised diameter of 1.1-2.0 cm.
    Comment: The specialty society representing dermatology objected to 
this proposal and contended that the excision of malignant lesions 
generally goes deeper and is more time-consuming than the excision of 
benign lesions and that malignant lesion excision also requires greater 
skill and embodies greater risk. The society stated that this proposal 
ignores a multi-specialty effort by a CPT Integumentary Workgroup, the 
CPT Editorial Panel and the RUC to revise the code descriptors and to 
assign work RVUs to these services. This view was supported by a joint 
comment from the heads of several surgical specialties. The RUC also 
urged us to delay finalizing this proposal until the RUC has the 
opportunity to provide further recommendations related to these 
services. In addition, the specialty societies representing podiatry, 
general surgery, colon and rectal surgery, osteopathy, ophthalmology, 
plastic surgery, otolaryngology as well as the AMA, the Mayo Foundation 
and individual physicians also urged us to withdraw this proposal. 
Medical Group Management Association requested the policy rationale for 
equating the work RVUs for the benign and malignant code pairs. The 
specialty society representing family physicians agreed with and 
supported our position that there is no difference in physician work 
involved in excising a benign or malignant lesion. However, the 
commenter did not support our proposal to implement such RVU changes 
unilaterally and stated that we should utilize the CPT and RUC process.
    Response and Final Decision: We still believe that the physician 
work for these services is sufficiently similar not to warrant 
differences in the work RVUs. However, we will maintain the 2003 work 
RVUs as interim values for 2004 to allow opportunity for the specialty 
to resurvey these services. Note: That due to the adjustments to work 
RVUs to match the MEI weights, the work RVUs in Addendum B may differ 
from the values in 2003.
3. Create G Codes for Monitoring Heart Rhythms
    As explained in the August 15, 2003 proposed rule, technological 
advances have made cardiac telemetry equipment, typically used in 
hospitals, available in the home setting. Coverage of this technology 
is currently at the discretion of the local Medicare contractors 
because there is no national coverage determination for this service. 
We proposed to establish new HCPCS codes to specifically describe this 
service along with proposed RVUs and PE inputs for payment as follows:
    GXXX1--Electrocardiographic monitoring for diagnosis of 
arrhythmias, utilizing a home computerized telemetry station and trans-
telephonic transmission, with automatic activation and real time 
notification of monitoring station, 24-hour attended monitoring, per 
30-day period of time; includes recording, monitoring, receipt of 
transmissions, analysis, and physician review and interpretation. 
(global)
    We proposed 0.52 physician work RVUs and 0.24 malpractice RVUs for 
this service and proposed crosswalking the practice expense inputs from 
CPT Code 93268 Patient demand single or multiple event recording with 
presymptom memory loop, 24-hour attended monitoring, per 30 day period 
of time; includes transmission physician review and interpretation.

[[Page 63216]]

    GXXX2--Electrocardiographic monitoring for diagnosis of 
arrhythmias, utilizing a home computerized telemetry station and trans-
telephonic transmission, with automatic activation and real time 
notification of monitoring station, 24-hour attended monitoring, per 
30-day period of time; recording (includes hook-up, recording and 
disconnection).
    We proposed 0.07 malpractice RVUs and crosswalked the practice 
expense inputs from CPT Code 93270, Patient demand single or multiple 
event recording with presymptom memory loop, 24-hour attended 
monitoring, per 30 day period of time; recording (includes hook-up, 
recording, and disconnection).
    GXXX3--Electrocardiographic monitoring for diagnosis of 
arrhythmias, utilizing a home computerized telemetry station and trans-
telephonic transmission, with automatic activation and real time 
notification of monitoring station, 24-hour attended monitoring, per 
30-day period of time; monitoring, receipt of transmissions, and 
analysis
    We proposed 0.15 malpractice RVUs and crosswalked the practice 
expense inputs from CPT Code 93271, Patient demand single or multiple 
event recording with presymptom memory loop, 24-hour attended 
monitoring, per 30 day period of time; monitoring, receipt of 
transmission, and analysis.
    GXXX4--Electrocardiographic monitoring for diagnosis of 
arrhythmias, utilizing a home computerized telemetry station and trans-
telephonic transmission, with automatic activation and real time 
notification of monitoring station, 24-hour attended monitoring, per 
30-day period of time; physician review and interpretation.
    We proposed 0.52 physician work RVUs and 0.02 malpractice RVUs and 
also crosswalked the practice expense inputs, from CPT code 93272 
Patient demand single or multiple event recording with presymptom 
memory loop, 24-hour attended monitoring, per 30 day period of time; 
physician review and interpretation only.
    Comment: Commenters representing cardiac arrhythmia specialists and 
cardiologists recommended that we withdraw the proposal to create new G 
codes for monitoring heart rhythms. The commenters stated that this 
request was not made by the medical community nor from the 
manufacturers of these heart rhythm monitoring systems. The commenters 
contended that the proposal appears to address specifically one 
manufacturer and specifies a particular mode of transmission and 
patient location, even though there are other new systems of this type 
that are not captured by this proposal.
    The commenters recommended that we allow this technology to be 
utilized on a local level before implementing a national coding 
solution. The commenters further supported that when this new 
technology warrants a national coding solution, a CPT coding 
application should be initiated and then the code should be sent to the 
RUC for review. The commenting specialties stated their willingness to 
provide medical input into the evaluation, coding and reimbursement for 
this new technology. Two commenters also stated that the descriptors 
and the proposed reimbursement do not reflect the monitoring systems 
that have been developed. Other commenters also requested that we 
withdraw or reconsider our proposal, as it did not follow the 
established process for creating and valuing new codes. One specialty 
society representing clinical endocrinologists supported the 
establishment of these HCPCS codes, while another commenter, a cardiac 
monitoring company, provided a general outline of how the various 
cardiac monitoring technologies can best be used for maximum quality 
and value. Another commenter suggested that until efficiency of the new 
technology is demonstrated this proposal should be postponed.
    Response: Our intention in proposing these G codes was to recognize 
and nationally price all currently available real time cardiac 
telemetry monitoring technology. It was not intended to address only 
one system currently in use. Based on the concerns raised by 
commenters, we will not proceed with these proposed HCPCS codes because 
we want to ensure that any HCPCS codes developed encompass the various 
technologies that are being utilized for such monitoring.
4. CPT Code 88180 (Flow Cytometry; Each Cell Surface, Cytoplasmic or 
Nuclear Marker)
    Flow cytometry is a technique to analyze single cell suspensions 
from blood, bone marrow, body fluids, lymph nodes, and other tissues. 
The technique, currently coded as CPT code 88180, Flow cytometry, each 
cell surface, cytoplasmic or nuclear marker, quantifies cell surface, 
cytoplasmic, and nuclear antigens. The August 15, 2003 proposed rule 
discussed our concerns that the current coding scheme (payment on a per 
marker basis) may encourage the performance of more markers than may be 
medically necessary because the pathologist determines what markers to 
perform and when to perform them. We indicated that we understood the 
laboratory community would be reviewing this issue and considering 
whether to recommend changes to the current coding for the procedure. 
We also requested recommendations on appropriate values for the 
procedure should we wish to develop a future proposal.
    Comments: Commenters, both individuals and organizations, asked 
that we not put forth a proposal for payment of flow cytometry. The 
College of American Pathologists (CAP) has proposed coding revisions to 
both the immunology and anatomic pathology section of CPT and is 
working with other groups to establish practice guidelines for flow 
cytometry. CAP asked that we not establish new ``G'' codes for 2004, 
but work with CAP and allow the CPT and RUC evaluation process to be 
used to determine appropriate coding and relative value units for flow 
cytometry.
    Decision: We agree with the commenters. We will work with CAP, the 
CPT and the RUC to develop appropriate coding and payment policies for 
flow cytometry.
5. Change in Payments to Physicians Managing Patients on Dialysis
    In the August 15, 2003 rule, we proposed to make CPT codes 90918, 
90919, 90920, and 90921 for the monthly capitation payments (MCP) 
invalid for Medicare. We also proposed to create 3 new G codes in place 
of each CPT code with payments varying with the number of visits 
provided within each month to an end stage renal disease (ESRD) 
patient. Under our proposal, there would be separate codes when the 
physician provides 1 visit per month, 2-3 visits per month and 4 or 
more visits per month. The code for 1 visit per month would have the 
lowest payment while a higher payment will be provided for 2 to 3 
visits per month and the highest payment for 4 or more visits per 
month. These new codes would be reported once per month for services 
performed in an outpatient setting that are related to the patient's 
ESRD. These physician services would continue to include the 
establishment of a dialyzing cycle, outpatient evaluation and 
management of the dialysis visits, telephone calls, and patient 
management provided during a full month. These codes would not be used 
if a hospitalization occurred during the month.
    The proposed codes are as follows:
    GXXX5--End Stage Renal Disease (ESRD) related services per full 
month, for patients under 2 years of age to

[[Page 63217]]

include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 4 or more face-to-face 
physician visits per month.
    GXXX6--End Stage Renal Disease (ESRD) related services per full 
month, for patients under 2 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 2 or 3 face-to-face physician visits per 
month.
    GXXX7--End Stage Renal Disease (ESRD) related services per full 
month, for patients under 2 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 1 face-to-face physician visit per month.
    GXXX8--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 2 and 11 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 4 or more face-to-face physician visits 
per month.
    GXXX9--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 2 and 11 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 2 or 3 face-to-face physician visits 
per month.
    GXX10--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 2 and 11 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 1 face-to-face physician visit per 
month.
    GXX11--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 12 and 19 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 4 or more face-to-face 
physician visits per month.
    GXX12--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 12 and 19 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 2 or 3 face-to-face 
physician visits per month.
    GXX13--End Stage Renal Disease (ESRD) related services per full 
month, for patients between 12 and 19 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 1 face-to-face physician 
visit per month.
    GXX14--End Stage Renal Disease (ESRD) related services per full 
month, for patients 20 years of age and over; with 4 or more face-to-
face physician visits per month.
    GXX15--End Stage Renal Disease (ESRD) related services per full 
month, for patients 20 years of age and over; with 2 or 3 face-to-face 
physician visits per month.
    GXX16--End Stage Renal Disease (ESRD) related services per full 
month, for patients 20 years of age and over; with 1 face-to-face 
physician visit per month.
    We based the proposed payments on the assumption that many 
physicians would provide 4 or more visits to their ESRD patients and a 
smaller proportion would provide 2-3 visits or only 1 visit per month. 
Using Medicare utilization data from 2002, we proposed the following 
relative value units for the new G codes that would make Medicare's 
aggregate payments for ESRD related services under the physician fee 
schedule approximately equal to current payments for procedure codes 
90918 to 90921:

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
                                                                                     Practice
                              Code                                Physician work      expense       Malpractice
----------------------------------------------------------------------------------------------------------------
GXXX5...........................................................           12.92            8.70            0.60
GXXX6...........................................................            5.19            3.49            0.24
GXXX7...........................................................            3.39            2.29            0.16
GXXX8...........................................................            9.91            4.86            0.43
GXXX9...........................................................            3.55            1.74            0.15
GXX10...........................................................            2.32            1.14            0.10
GXX11...........................................................            8.47            4.54            0.35
GXX12...........................................................            3.14            1.68            0.13
GXX13...........................................................            2.05            1.10            0.08
GXX14...........................................................            5.16            2.94            0.22
GXX15...........................................................            1.94            1.10            0.08
GXX16...........................................................            1.27            0.73            0.06
----------------------------------------------------------------------------------------------------------------

    As part of the proposed rule we also solicited comments on how to 
further revise our payment methodology to improve quality of care and 
outcomes. We requested information that could help us design future 
demonstrations that would study both dimensions of care (quality and 
utilization) and help ensure that payment is based on appropriate 
patient-specific care that has been shown to lead to improved outcomes 
for this complex patient population.
    Comment: We received many comments from physicians, the RUC, 
specialty societies, dialysis centers and nephrologists, as well as 
other individuals and organizations who expressed concerns with our 
proposal to alter the way physicians are reimbursed for services 
provided to End Stage Renal Disease (ESRD) patients and who urged us to 
withdraw the proposal. The RUC and the AMA, as well as other specialty 
organizations, expressed disappointment that we developed this proposal 
without consultation from the medical community and outside the usual 
CPT and RUC process. The Renal Physicians Association (RPA), the 
American Society for Nephrology (ASN), the American Association for 
Kidney Patients (AAKP), and the National Kidney Foundation (NKF) all 
supported the principle of optimizing nephrologist-dialysis patient 
interaction, which is included in the proposal. However, the RPA 
contended that the proposal as currently constituted is unworkable, may 
negatively impact some dialysis patients and is being put on an 
unreasonably precipitous implementation schedule. The AAKP outlined 
similar concerns but believed that increased nephrologist-dialysis 
patient interaction will lead to improved outcomes and also urged that 
an advisory committee be established to assist in the effort to further 
improve quality and coordination of care for dialysis

[[Page 63218]]

patients. The Medicare Payment Advisory Commission (MedPAC) agreed that 
the current payment method lacks accountability and quality incentives, 
and thus encouraged CMS to address these issues. However, MedPAC also 
expressed concern that without baseline data it was unclear how we 
could determine and measure the impact of the proposed changes on 
quality and access. MedPAC further stated that the adjustments to 
payment should be made subsequent to the collection of information on 
resource costs and clinical guidelines. Together with these 
adjustments, further incentives should be added to the monthly payment 
to reward and improve the quality and access of dialysis-related 
physician care, which is consistent with MedPAC's June 2003 
recommendations. Below are the specific issues raised by commenters:

Disproportionate Payment Differences

    Many comments concerned the large variation in proposed payments to 
physicians who see a patient only once a month, compared to the 
proposed payment for seeing a patient either two or three times during 
the month or four or more times during the month. In addition, 
commenters stated there is more work involved in managing care of the 
ESRD patients between visits.
    Response: Based on our review of the comments, we agree that a 
significant amount of physician work for patients with ESRD occurs 
outside of the face-to-face visit with the patients. Since there may be 
significant physician work associated with providing physician services 
to ESRD patients between visits, we agree that there should be less 
difference in the payment levels than we proposed. By raising the 
minimum payment level, we are accounting for the extensive patient care 
coordination and other non-face-to-face management required by ESRD 
patients. However, we continue to believe that more physician work is 
associated with more frequent face-to-face visits with the patient, and 
any variation in the payment amounts should reflect this difference.
    First, we determined the appropriate relative relationship among 
different codes. For instance, we believe that approximately 25 percent 
more physician work is involved with providing two to three visits than 
with a single visit, and 50 percent more physician work is associated 
with providing four or more visits. By paying a single amount 
regardless of how often the patient is seen, we believe our current 
policy pays too much if the patient is seen fewer than four times per 
month. Thus, we revised our payment to be consistent with different 
levels of physician work associated with providing monthly management 
of dialysis patients. We are setting our aggregate revised payments 
equal to aggregate current payments. Consistent with these assumptions, 
we determined the following RVUs:

                                               Table 3.--Relative Values for New Monthly Capitation Codes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Practice
           Age of patient                       HCPCS               Number of visits           Work           expense       Malpractice        Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Patients Other Than Home Dialysis
--------------------------------------------------------------------------------------------------------------------------------------------------------
<2..................................  G0308                     4+......................           12.69            8.58            0.42           21.69
                                      G0309                     2 to 3..................           10.57            7.13            0.36           18.06
                                      G0310                     One Visit...............            8.45            5.72            0.28           14.45
2 to 11.............................  G0311                     4+......................            9.68            4.74            0.34           14.76
                                      G0312                     2 to 3..................            8.07            3.94            0.29           12.30
                                      G0313                     One visit...............            6.46            3.16            0.22            9.84
12 to 19............................  G0314                     4+......................            8.24            4.45            0.26           12.95
                                      G0315                     2 to 3..................            6.87            3.69            0.23           10.79
                                      G0316                     One visit...............            5.50            2.96            0.17            8.63
20 +................................  G0317                     4+......................            5.07            2.88            0.17            8.12
                                      G0318                     2 to 3..................            4.23            2.39            0.14            6.76
                                      G0319                     One Visit...............            3.38            1.92            0.11            5.41
-------------------------------------
                                                          Home dialysis patients (entire month)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<2..................................  G0320                     ........................           10.57            7.13            0.36           18.06
12 to 19............................  G0321                     ........................            6.87            3.69            0.23           10.79
2 to 11.............................  G0322                     ........................            8.07            3.94            0.29           12.30
20 +................................  G0323                     ........................            4.23            2.39            0.14            6.76
-------------------------------------
                                                  Home dialysis patients (partial month only--per day)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<2..................................  G0324                     ........................            0.35            0.24            0.01            0.60
12 to 19............................  G0325                     ........................            0.23            0.12            0.01            0.36
2 to 11.............................  G0326                     ........................            0.27            0.13            0.01            0.41
20 +................................  G0327                     ........................            0.14            0.08            0.01            0.23
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We used the above principles to establish our monthly capitation 
payments (MCP) for patients 20 or older. For patients younger than 20, 
we are using the same relationship that exists among the current MCP 
codes for different age groups for the new codes that we are creating. 
For example, the current MCP code for a patient under 2 (CPT code 
90918) has work RVUs that are approximately 2.5 times the work RVU for 
a patient 20 or older (CPT code 90921). Thus, Medicare's work RVU for 
each code for a patient 2 years or younger will be 2.5 times the amount 
of the corresponding service provided to a patient 20 or older. These 
values can be considered as interim and we plan to seek the advice of 
the RUC in evaluating these codes once the policy has been implemented. 
There are efforts underway (for example, in their 2004 workplan, the 
OIG has indicated they will conduct a review of ESRD monthly capitation 
payments and physician services) which will provide data on the type 
frequency and content of physician

[[Page 63219]]

encounters as suggested by MedPAC. However, we believe a change should 
be made in the interim to improve care and accountability. The use of 
these new codes will also enable us to collect data about the frequency 
of physician visits.

Regulatory Impact of Proposal on SGR and Conversion Factor

    We received comments regarding the impact of these proposed changes 
on the sustainable growth rate (SGR) calculations. Commenters expressed 
concern that, if physician behavior changes and physicians increase the 
number of visits provided per month, actual expenditures would surpass 
the target projection, resulting in a future payment reduction for all 
of medicine.
    Response: Section 1848(c)(2)(B)(ii)(II) of the Act requires that 
changes to RVUs cannot cause the amount of expenditures to increase or 
decrease by more than $20 million from the amount of expenditures that 
would have been made if such adjustments had not been made. As 
indicated above, we have established RVUs for the new monthly 
capitation codes so that Medicare's aggregate payments for these 
services are equal to what we would have paid in the absence of these 
changes. We are not expecting any impact on payment for other physician 
fee schedule services. However, we will continue to review this issue 
as we work with the medical community to further refine Medicare policy 
for treating patients needing dialysis services.

Home Dialysis

    Many comments were received regarding home dialysis because 
patients who dialyze at home typically see their physicians less 
frequently than other ESRD patients. One commenter suggested that home 
dialysis patients be excluded from the proposed change and that we 
continue to pay the current MCP rate for services to these patients.
    Response: We have created four G codes for the management of home 
dialysis patients in each of the age groups and will pay for the home 
dialysis patients at the same rate as codes G0309, G0312, G0315, and 
G0318 respectively. Although the codes for home dialysis patients will 
pay physicians slightly less than the former MCP, physicians will still 
have a relative incentive to increase the use of home dialysis. We 
believe this is consistent with Section 1881(b)(3)(B) of the Social 
Security Act which states ``With respect to payments for physicians' 
services furnished to individuals determined to have end stage renal 
disease, the Secretary shall pay 80 percent of the amounts calculated 
for such services on a comprehensive monthly fee or other basis (which 
effectively encourages the efficient delivery of dialysis services and 
provides incentives for the increased use of home dialysis) for an 
aggregate of services provided over a period of time (as defined in 
regulations).''
    The new G codes for the monthly management of home dialysis 
patients will be as follows:
    G0320--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients under two years of age 
to include monitoring for adequacy of nutrition, assessment of growth 
and development, and counseling of parents.
    G0321--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients two to eleven years of 
age to include monitoring for adequacy of nutrition, assessment of 
growth and development, and counseling of parents.
    G0322--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients twelve to nineteen years 
of age to include monitoring for adequacy of nutrition, assessment of 
growth and development, and counseling of parents.
    G0323--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients twenty years of age and 
older.
    The American Society of Nephrology also commented that 
``reimbursement should be constructed so that home dialysis patients 
should see their nephrologist at least monthly, with further visits on 
an as needed basis.'' We will not specify the frequency of required 
visits at this time but expect physicians to provide clinically 
appropriate care to manage the home dialysis patient.
    If home dialysis patients are hospitalized during the month, four 
new G codes have been created: G0324, G0325, G0326, and G0327. These 
codes will be used to report daily management of home dialysis patients 
for the days the patient is not in the hospital. CPT codes 90922, 
90923, 90924, and 90925 will be considered inactive for Medicare 
because they are now redundant as other codes are to be used by 
physicians billing for services to ESRD patients.
    The new G codes are as follows:
    G0324--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients under two years 
of age.
    G0325--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients between two and 
eleven years of age.
    G0326--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients between twelve 
and nineteen years of age.
    G0327--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients twenty years of 
age and over.
    For example, if a home dialysis patient is in the hospital for 10 
days (counting the calendar day of admission and the calendar day of 
discharge) and is cared for 20 days in his or her home, then 20 units 
of the code for the appropriate aged patient is billed.
    If a home dialysis patient receives dialysis in a dialysis center 
or other facility during the month, the physician is still paid the 
management fee for the home dialysis patient and cannot bill the codes 
in the range of G0308 through G0319 or CPT codes 90935 or 90937, even 
though the physician may see the patient during his/her center 
dialysis.

Role of Non-Physician Practitioners or Physicians Other Than the MCP 
Physician

    We received comments about the role of nonphysician practitioners. 
It was not clear to the commenters whether visits by these 
practitioners could count as face-to-face encounters by the MCP 
physician. The commenters also asked about billing by physicians (for 
example, a ``rounding'' physician or fellow) other than the physician 
who is billing the monthly capitation rate.
    Response: Physicians may utilize nonphysician practitioners: nurse 
practitioners, physician assistants, and clinical nurse specialists, 
who are able under the Medicare statute to furnish services that would 
be physician services if furnished by a physician and who are eligible 
to enroll in the Medicare program, to deliver some of the visits during 
the month. The rules for the use of these physician extenders would be 
consistent with the rules for split/shared evaluation and management 
visits: The nonphysician practitioners and physician must be in the 
same group practice or employed by the same employer/entity; and the 
physician must perform some portion of the service in a face-to-face 
encounter, in this case one or more visits during the month with the 
patient. In this situation, to bill the service under the physician's 
UPIN/PIN, the physician and not the physician extender should be the 
practitioner to perform the visit with the complete assessment of the 
patient and to establish the patient's

[[Page 63220]]

plan of care. If the nonphysician practitioner is the practitioner who 
performs the complete assessment and establishes the plan of care, then 
the MCP service should be billed under the UPIN/PIN of the nurse 
practitioner, physician assistant, or clinical nurse specialist.
    It is also possible for the physician to use another physician to 
provide some of the visits during the month, but the physician who 
provides the complete assessment, establishes the patient's plan of 
care and provides the ongoing management should be the physician who 
submits the bill for the monthly service. The non-MCP physician must 
have a relationship with the billing physician such as a partner, 
employees of the same practice, or supervising physician and fellow 
doing sub-specialty training.
    Each practitioner should document in a shared medical record 
services he/she personally performed. Only one practitioner can bill 
for the management of the ESRD patient in any month. In addition, when 
a nonphysician practitioner or a ``rounding physician'' sees a dialysis 
patient for management of ESRD, they cannot bill an evaluation and 
management service for the same patient unless there is a separate, 
substantial and documented service evaluating the patient for care 
unrelated to the patient's dialysis.

Geographic Issues

    Commenters indicated that the lack of geographic considerations 
would negatively impact physicians and patients in rural and some urban 
settings where physician visits require significant travel time. 
Extended travel time can make it difficult for physicians to see 
patients as often as patients can be seen when the physician's office 
is near the dialysis facility.
    Response: We believe that the policy to allow nurse practitioners, 
physician's assistants, clinical nurse specialists, and other 
physicians to deliver some of the visits to patients as well as changes 
in the payment to more accurately reflect non-visit services and the 
relative value of additional visits will ameliorate these access 
issues.

Lack of Clarity Regarding Hospitalization

    Commenters noted that the proposed rule did not provide enough 
detail regarding alternative billing procedures if hospitalization 
occurs during the month.
    Response: For ESRD patients (other than home dialysis patients) who 
are hospitalized during the month, the physician may bill the code that 
reflects the number of face-to-face visits during the month on days 
when the patient was not in the hospital (either admitted as an 
inpatient or in observation status).

Documentation Requirements

    Comment: Many commenters asked for clarification regarding the 
documentation requirements, if any, associated with the new codes.
    Response: We have chosen not to include specific documentation 
guidelines in this rule. Instead, physicians should document what is 
clinically relevant, including but not limited to the patient's current 
status and complaints, a clinically appropriate physical examination, 
assessment of the patient's treatment for ESRD that includes assessment 
of the adequacy of the dialysis treatment, the status of the patient's 
vascular access, assessment and treatment of the other conditions 
associated with ESRD, such as anemia, electrolyte management, and bone 
density, as well as changes to the patient's management.
HIPAA Compliance
    Comment: A comment was received that HIPAA transaction and code set 
rules may not be met if these new codes were implemented.
    Response: G codes are part of the HCPCS coding system and are in 
compliance with the HIPAA transaction and code set rules.

Outpatient Settings

    Comment: Commenters asked for additional clarification on whether 
visits counted toward the MCP can be provided in settings other than 
the dialysis facility.
    Response: The visits for management of ESRD patients may occur in 
the physician's office, in an outpatient hospital or other outpatient 
setting or even in the patient's home as well as in the dialysis 
facility.

Transient Patients

    Comment: Commenters inquired how physicians would deal with visits 
and related billing for traveling patients who receive their treatment 
away from their usual site of treatment.
    Response: If the physician manages the care of a patient who is 
receiving treatment away from the patient's usual site of treatment, 
the physician who bills for managing the care of the patient is still 
paid according to the number of times the physician has a face-to-face 
visit with the patient. If the patient is to be away for an extended 
period of time, the patient would be managed by the physician who has 
face-to-face visits with the patient, and that physician would be the 
one billing for the patient's care management.

Quality of Care and Outcomes

    Comment: Commenters representing the American Osteopathic 
Association, the American Academy of Family Physicians, the National 
Coalition for Quality Diagnostic Imaging Services, the American Society 
for Echocardiography and Focus on Therapeutic Outcomes, Inc., provided 
information on quality initiatives their respective organizations have 
undertaken or suggestions for relating quality to payment. The National 
Kidney Foundation recommended the use of technology and other forms of 
communication to care for ESRD patients and to support constant 
attention to quality. In addition, the Society for Interventional 
Radiology commended our efforts to increase the use of arteriovenous 
fistulae for vascular access in dialysis patients as part of its 
National Vascular Access Improvement Initiative, but indicated there 
might be a need to clarify certain policies. The American Association 
of Kidney Patients (AAKP) also recommended the establishment of a 
commission or advisory group with representation of the kidney 
community that could be charged with recommending proposals to tie 
reimbursement to outcomes. AAKP stated that although the proposed 
changes are important, these changes remain a change in process of 
delivery of care that may improve actual outcomes, rather than a change 
in actual outcomes, that is, in rehabilitation, morbidity, mortality, 
and quality of life. MedPAC agreed with CMS that the proposed change to 
provide incentives for additional nephrologist-dialysis patient 
interactions may not be the ideal method to improve patient outcomes 
and to achieve this goal, CMS should partner with the ESRD community 
and work toward a long-term solution. MedPAC suggested that we 
investigate and incorporate physician clinical practice guidelines into 
our payment approach, and measure physician quality directly. MedPAC 
also suggested that we examine whether physician resources vary based 
on patient complexity, stating that to the extent that resources do 
vary, a case-mix adjustment--similar to the one MEDPAC recommended for 
payment to dialysis facilities in its June 2003 report--would be 
desirable.
    Response: We appreciate the information and suggestions provided by 
the commenters and will take these into consideration. We plan to 
investigate the use of new technology to improve the management of ESRD

[[Page 63221]]

patients as part of our overall focus on quality.
    Final Decision--We will create the following G Codes to be used for 
ESRD patients other than home dialysis, based on the age of the patient 
and number of visits:
    G0308--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients under 2 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 4 or more face-to-face 
physician visits per month.
    G0309--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients under 2 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 2 or 3 face-to-face 
physician visits per month.
    G0310--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients under 2 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 1 face-to-face physician 
visit per month.
    G0311--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 2 and 11 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 4 or more face-to-face 
physician visits per month.
    G0312--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 2 and 11 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 2 or 3 face-to-face 
physician visits per month.
    G0313--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 2 and 11 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 1 face-to-face 
physician visit per month.
    G0314--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 12 and 19 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 4 or more face-to-face 
physician visits per month.
    G0315--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 12 and 19 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 2 or 3 face-to-face 
physician visits per month.
    G0316--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients between 12 and 19 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents; with 1 face-to-face 
physician visit per month.
    G0317--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients 20 years of age and over; with 4 or 
more face-to-face physician visits per month.
    G0318--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients 20 years of age and over; with 2 or 3 
face-to-face physician visits per month.
    G0319--End Stage Renal Disease (ESRD) related services during the 
course of treatment, for patients 20 years of age and over; with 1 
face-to-face physician visit per month.
    In addition we have created the following G codes for home dialysis 
patients:
    G0320--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients under two years of age 
to include monitoring for adequacy of nutrition, assessment of growth 
and development, and counseling of parents.
    G0321--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients two to eleven years of 
age to include monitoring for adequacy of nutrition, assessment of 
growth and development, and counseling of parents.
    G0322--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients twelve to nineteen years 
of age to include monitoring for adequacy of nutrition, assessment of 
growth and development, and counseling of parents.
    G0323--End stage renal disease (ESRD) related services for home 
dialysis patients per full month; for patients twenty years of age and 
older.
    G0324--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients under two years 
of age.
    G0325--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients between two and 
eleven years of age.
    G0326--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients between twelve 
and nineteen years of age.
    G0327--End stage renal disease (ESRD) related services for home 
dialysis (less than full month), per day; for patients twenty years of 
age and over.
6. Miscellaneous Coding Issues

Bioimpedance

    Comment: We received several comments concerning the pricing of CPT 
code 93701, electrical bioimpedance. One commenter, a carrier medical 
director, requested that this service be considered a technical 
component service as there is no physician work (professional 
component) required to produce the results. The commenter referenced 
the RUC recommendation of 0.00 work that was not accepted by CMS in 
November 2001. Other commenters stated that pricing of this service 
should be revisited and the American College of Cardiology recommended 
work component of 0.25 RVUs be accepted. Commenters also questioned the 
valuation of the practice expense component, particularly in light of 
the escalating costs associated with this service.
    Response: In next year's final rule we will be accepting 
recommendations for codes to be considered under the five-year review 
of work that will occur in 2005. The commenters will be able to respond 
to that solicitation, and submit this CPT code, as well as any other 
services they believe need to be reviewed to ensure they are 
appropriately valued. We are currently in the process of reviewing and 
obtaining updated pricing for equipment contained in the practice 
expense data files and proposed changes to pricing for equipment will 
be included in next year's proposed rule. We would suggest that the 
commenters review this information when published to ensure that the 
cost of the equipment is accurately reflected in the database.

Ablation Procedures

    Comment: One commenter, a manufacturer, suggested that the work 
RVUs of certain codes for the ablation of liver tumors (CPT codes 
47380, 47370 and 47382) appeared to be undervalued.
    Response: As discussed in the previous response, in next year's 
final rule we will be accepting recommendations for codes to be 
considered under the five-year review of work that will occur in 2005. 
The

[[Page 63222]]

commenter will be able to respond to that solicitation and submit these 
codes, as well as any additional services they believe need to be 
reviewed to ensure they are appropriately valued.

Stereotactic Radiosurgery and Stereotactic Radiotherapy

    Comment: Two commenters requested that HCPCS codes G0173 and G0251, 
which are used for reporting stereotactic radiotherapy and stereotactic 
radiosurgery under the hospital outpatient prospective payment system, 
be activated for payment under the physician fee schedule.
    Response: We are reluctant to establish payment for these services 
under the physician fee schedule at this time absent specific 
information on freestanding centers providing this service. We would 
welcome information and data from these commenters, and other 
individuals and providers, on the provision of these services in 
freestanding centers so that we can fully evaluate this issue.

Creation of G Codes

    Comment: The AMA and several specialty organizations expressed 
concern about the establishment of the numerous G codes that were 
contained in the proposed rule. The commenters state that continual 
development of G codes, without consultation with the CPT Editorial 
Panel, the RUC or the physician community undermines the annual review 
process that CMS has established in the final rule. Further, the 
commenters argue that the establishment of G Codes undermines the 
requirements of the Health Insurance Portability and Accountability Act 
(HIPAA) for coding standardization and an open process for establishing 
codes.
    Response: As we have stated in previous rulemaking, it is sometimes 
necessary to develop G codes to accommodate changes in legislation, 
regulation, coverage, and payment policy. We appreciate the input of 
the medical community and to the extent possible, will work with the 
CPT Editorial Panel, the RUC and the physician community prior to 
establishment of these codes.

Pain Management

    Comment: The American Society of Interventional Pain Management 
commented on the differences in payment allowances for various pain 
management services and other non-pain management services furnished in 
conjunction with pain management services in various settings, 
including the physician's office, the OPD and the ASC.
    Response: In accordance with the law, we have established payment 
rates for office-based procedures, using the non-facility practice 
expense relative value units. However, the office does not represent a 
practice site where these services are usually performed.
    Medicare payment under the physician fee schedule for the physician 
work is the same in all practice settings. However, the practice 
expenses are reimbursed differently depending on the practice site. 
Practice expenses associated with procedures performed in the 
outpatient departments (OPDs) or ambulatory surgical centers (ASCs) are 
paid under the OPD or ASC payment system respectively. Practice 
expenses associated with procedures performed in the physician's office 
are paid through the physician fee schedule payment system.

III. Other Issues

A. Definition of Diabetes for Diabetes Self-Management Training

    In the August 15, 2003 rule we proposed to adopt the definition of 
diabetes used to determine beneficiary eligibility for Medical 
Nutrition Therapy (MNT) for purposes of coverage for outpatient 
diabetes self-management training when the beneficiary has a diagnosis 
of diabetes. Specifically, we stated that the criteria currently set 
forth at Sec.  410.141(d), would be replaced with definition of 
diabetes used for medical nutrition therapy at Sec.  410.130 which 
reads as follows:
    Diabetes means diabetes mellitus consisting of two types. Type 1 is 
an autoimmune disease that destroys the beta cells of the pancreas, 
leading to insulin deficiency. Type 2 is familial hyperglycemia that 
occurs primarily in adults but can also occur in children and 
adolescents. It is caused by an insulin resistance whose etiology is 
multiple and not totally understood. Gestational diabetes is any degree 
of glucose intolerance with onset or first recognition during 
pregnancy. The diagnostic criterion for a diagnosis of diabetes for a 
fasting glucose intolerance test is greater than or equal to 126 mg/dL.
    A technical error in the proposed rule on page 49070, placed the 
revised eligibility requirements in Sec.  410.141(f). The eligibility 
requirements will replace those currently in Sec.  410.141(d).
    Comment: We received comment noting that the language for the 
actual regulatory language had the wrong section letter.
    Response: As noted above, this was a technical error.
    Final Decision: The following language will replace what was in the 
proposed rule. ``Section 410.141 is amended by replacing paragraph (d) 
to read as follows: Sec.  410.141 Outpatient diabetes self-management 
training. (d) Beneficiaries who may be covered. Medicare Part B covers 
outpatient diabetes self-management training for a beneficiary who has 
been diagnosed with diabetes.''
    Comment: The comments were very supportive of our efforts to 
streamline this requirement. Several commenters recommended that the 
definition of diabetes be revised to include patients who might not be 
classified as Type 1, Type 2, or gestational diabetes in the 
definition. Most commenters recommended the use of a fasting glucose 
test of greater than or equal to 126 mg/dL. One commenter suggested the 
measurement be taken on two occasions. Most commenters also recommended 
the addition of a random glucose test of greater than 200 mg/dL, with 
one commenter adding with symptoms of uncontrolled diabetes. Several 
commenters suggested use of an abnormal glucose tolerance test (GTT). 
One commenter also suggested the use of a 2 hour post-glucose challenge 
of greater than or equal to 200 mg/dL test on two different occasions. 
The American Association of Clinical Endocrinologists (AACE) also 
suggested that coverage of medical nutrition therapy be expanded to 
those with impaired fasting glucose.
    Response: The definition of diabetes used in the MNT regulation was 
based on language found in the 2000 Institute of Medicine report 
entitled, ``The Role of Nutrition in Maintaining Health in the Nation's 
Elderly. We did not have any other generally recognized definition of 
diabetes at that time and did not intend to limit our definition of 
diabetes. Regarding the laboratory tests, the characteristics of the 
commenters' suggestions are generally the same. The base measurement 
that is already in our MNT regulation, a fasting glucose of 126 mg/dL, 
is a common measure. Three commenters also noted the use of 200 mg/dL 
for a random glucose test. The major variation between the commenters 
was that one suggested multiple measurements. Also, we note that 
patients with an impaired fasting glucose level do not necessarily meet 
any of the popular definitions of diabetes.
    Final Decision: We agree that in some ways our proposed definition 
may not include some patients diagnosed with diabetes. We also agree 
that our clinical

[[Page 63223]]

laboratory measurements used to determine the presence of diabetes 
should be expanded. The definition provided by AACE appears to meet the 
clinical concerns of the medical community and our concerns that no 
individuals have their treatments delayed unduly if they have obvious 
symptoms of uncontrolled diabetes. Therefore, we are adopting their 
clinical definition. We will also broaden our general language to 
include diabetes of other types. Our final language will be, ``Diabetes 
is diabetes mellitus, a condition of abnormal glucose metabolism 
diagnosed using the following criteria: A fasting blood sugar greater 
than or equal to 126 mg/dL on two different occasions; a 2 hour post-
glucose challenge greater than or equal to 200 mg/dL on 2 different 
occasions; or a random glucose test over 200 mg/dL for a person with 
symptoms of uncontrolled diabetes.'' We will also make a conforming 
amendment to 410.130 for MNT. However, we are constrained from covering 
MNT for anyone who is not diagnosed with diabetes by the section 
1861(s)(2)(V) of the Act that limits coverage of MNT to beneficiaries 
with diabetes or renal disease.

Outpatient Therapy Services Performed ``Incident To'' Physicians'' 
Services--Discussion Only

    In almost all settings, our regulations specify that outpatient 
therapy services can be delivered only by qualified physical 
therapists, occupational therapists, physical therapy assistants, 
occupational therapy assistants, and speech-language pathologists as 
defined by Sec.  484.4. Section 1862(a)(20) of the Act requires that 
any therapy services furnished incident to a physician's professional 
services must meet the standards and conditions that would apply to 
such therapy services if they were furnished by a therapist, with the 
exception of the licensing requirement. While there are currently no 
national standards for qualifications of individuals providing 
outpatient therapy services incident to physicians' services, we 
believe that standards similar to those in Sec.  484.4 are appropriate. 
In the proposed rule, we stated that we are considering adopting the 
existing qualification and training standards (with the exception of 
licensure) in Sec.  484.4 for individuals providing therapy services 
independently and incident to physicians' services. While we did not 
propose a change at this time, we requested comments from the public, 
particularly physicians and staff who would be affected, on adoption of 
the existing standards in Sec.  484.4, for services of independent 
therapists and ``incident to'' services, as well as comments regarding 
alternatives that we might use to ensure that qualified staff are 
providing ``incident to'' therapy services.
    We received comments from major therapy organizations and 
individual therapists representing therapy services, physician 
organizations and individual physicians and associations and 
individuals representing other health care professionals, such as 
athletic trainers, kinesiotherapists and exercise physiologists. A wide 
spectrum of views was expressed by these commenters. Commenters 
representing therapists were supportive of establishing consistent 
training standards in all settings, while physicians favored reliance 
on the individual physician for quality control. The non-therapist 
health care providers were concerned about their role in providing 
therapy services and cardiac rehabilitation and pulmonary service 
providers were concerned that their services might be affected.
    We will review and consider these comments as we determine whether 
to make a future proposal. Meanwhile, contractors may continue to 
develop local medical review policies that are consistent with the 
statute, applying to physical therapy, occupational therapy and speech-
language pathology services the same standards and conditions that 
would apply to such therapy services if they were furnished by an 
independent therapist, with the exception of the licensing requirement.

D. Status of Anesthesia Work and Five-Year Review

    In the December 2002 final rule, we modestly increased the work of 
anesthesia services. These changes were based on the analysis submitted 
by the RUC of its review of the work of 19 high volume anesthesia 
codes. The RUC had provided us with its analysis but did not furnish us 
with a definitive recommendation. The increase in anesthesia work 
resulted in an increase in the national anesthesia conversion factor. 
(We increased the physician work component of the anesthesia conversion 
factor by 2.10 percent to reflect a 9.13 percent increase in anesthesia 
work applied to 23 percent of anesthesia allowed charges represented by 
the 19 codes. As a result of this increase, we applied a 1.6 percent 
increase to the anesthesia CF.) The American Society of 
Anesthesiologists expressed concern about the completeness of the 
review of anesthesia codes under the five-year review. Therefore, in 
February 2003 we asked the RUC to continue its review of anesthesia 
work values so that we could develop a final recommendation for a 
change in the anesthesia CF involving all anesthesia codes. In the 
proposed rule we stated we were waiting on the RUC's response to our 
request.
    The RUC has spent a considerable amount of effort of studying this 
issue. The RUC's anesthesia workgroups consisted of a range of 
physician specialists, including various surgical specialists, who have 
knowledge about the anesthesia services studied. As a result of their 
review, the RUC approved and presented the following recommendations to 
CMS:
    1. The RUC position is that the 5-year review has been completed.
    2. The RUC anesthesia workgroup analysis only applies to the 19 
anesthesia codes and associated 19 surgical codes.
    3. The Workgroup recommendations to the RUC stated that there are 
structural differences between the anesthesia coding system and the 
remainder of the physician coding system, which contributes to the 
difficulties in making extrapolations to the entire set of anesthesia 
services. Among other things, the workgroups and the RUC were concerned 
that the anesthesia codes cover too large a number of surgical codes 
making it necessary to examine surgical codes within the anesthesia 
code, and the 19 selected anesthesia codes may not be the most 
representative codes.
    The ASA disagrees with the RUC's recommendations and asked that we 
extrapolate from the 19 surveyed procedures to all anesthesia codes.

Decision

    When we developed the 2002 final physician fee schedule rule on the 
second five-year review, one of our concerns was that the RUC's initial 
findings were not presented as specific recommendations. We wanted to 
pursue approaches consistent with RUC recommendations. Therefore, in 
early 2003, we asked the RUC to more clearly present their 
recommendations.
    Based on our review of the history and analysis of this issue and 
the final recommendation of the RUC, we have decided not to extrapolate 
from the surveyed procedures to the entire universe of anesthesia 
procedures; we will make no further adjustments to anesthesia work 
under the second five-year review.

[[Page 63224]]

Payment Policies for Anesthesia Services

    There are differences in Medicare payment policies between a 
teaching anesthesiologist involved with two concurrent cases with 
residents and a teaching CRNA involved with two concurrent cases with 
student nurse anesthetists.
    Currently, if a teaching anesthesiologist is involved with two 
concurrent cases with anesthesia residents, the medical direction rules 
apply. Payment for the physician's medical direction is based on 50 
percent of the allowance otherwise allowed if the anesthesiologist 
performed the anesthesia case alone.
    For anesthesia services furnished prior to July 1, 2002, we allowed 
full payment if a non-medically directed certified registered nurse 
anesthetist (CRNA) supervised a single case involving a student nurse 
anesthetist. No payment was made if the teaching CRNA supervised two 
cases involving student nurse anesthetists. In August 2002, we released 
the Medicare Carriers Manual Transmittal 1766 relating to the 
involvement of a non-medically directed teaching CRNA with two student 
nurse anesthetists. The American Association of Nurse Anesthetists 
(AANA) noted that their standards for approved nurse anesthesia 
training programs allow the teaching CRNA to supervise two concurrent 
cases involving student nurse anesthetists. The new policy allows the 
teaching CRNA to be paid, for his/her involvement with two concurrent 
cases with student nurse anesthetists, but not at the full fee level. 
If a teaching CRNA is involved with two concurrent cases with student 
nurse anesthetists, payment may be based on the base unit plus the time 
that the teaching CRNA is present with the student nurse anesthetist. 
To bill the base unit, the teaching CRNA must be present with the 
student nurse anesthetist throughout the pre- and post-anesthesia care. 
This payment per case is usually higher than the 50 percent paid to the 
teaching anesthesiologist for medically directing resident cases.
    In the proposed rule, we asked for comments on the appropriateness 
of applying the CRNA teaching/resident policy to teaching 
anesthesiologists.
    Comment: The American Association of Nurse Anesthetists commented 
that it was unclear how the new rule for teaching anesthesiologists 
would operate with the medical direction rules, particularly if there 
were more than two concurrent anesthesia cases.
    Response: The new policy for teaching anesthesiologists would apply 
only when there are two concurrent cases, and the cases involve 
residents. The medical direction payment policy would continue to 
apply, as it has previously, for three or four concurrent anesthesia 
cases regardless of the qualified individual (for example, CRNA, 
resident, or anesthesiologist assistant) who is administering and 
monitoring anesthesia under the physician's medical direction.
    Comment: The ASA requested that the teaching anesthesiology payment 
regulations be revised so that the teaching anesthesiologists be paid 
in a similar manner to teaching surgeons. Under the teaching physician 
rules, the teaching surgeon can be paid the full fee for each of two 
overlapping surgeries involving residents. The ASA understands that 
such a proposal would require a revision to Medicare regulations and 
would require rulemaking.
    The ASA requested that, at least, in the interim, we allow teaching 
anesthesiologists to be paid similarly to teaching CRNAs for two 
concurrent cases. However, ASA specifically requested that this policy 
be used in addition to the current medical direction payment policy. In 
other words, the ASA wants the teaching anesthesiologist to be able to 
choose case-by-case, whether to seek payment similar to the teaching 
CRNA (that is, full base units and time units based only on actual 
presence with the resident) or based on the medical direction rules 
(that is, 50 percent of the full base and time units).
    According to the ASA, a number of anesthesiology department heads 
believe the nurse anesthesia payment rule is not appropriate to the 
teaching of already-licensed physicians. They question the need for the 
teaching physician to participate in the pre- and post-op anesthesia 
care (to obtain full base units), they think that participation of the 
teaching anesthesiologist in the key portions of the procedure is far 
more important than the number of minutes present with the resident 
(which is the relevant consideration under the teaching physician 
policy for a single case with a resident).

Response and Final Decision

    We have decided to allow teaching anesthesiologists to bill, 
similarly to teaching CRNAs, for their involvement in two concurrent 
cases involving residents. This will apply to anesthesia services 
furnished on or after January 1, 2004.
    The anesthesiologist can bill base units and actual time, based on 
the amount of time the physician is present with the resident during 
each of two concurrent cases. To bill base units, the physician must be 
present with the resident during the pre- and post-anesthesia care 
included in the base units. If the physician is not present with the 
resident during the pre- and post-anesthesia care, the physician may 
bill the case as a medically directed case.
    The anesthesiologist must document his/her involvement in cases 
with anesthesia residents. The documentation must be sufficient to 
support the payment of the fee and available for review upon request. 
We have revised Sec.  414.46 to incorporate this change.

F. Technical Correction

    CPT Code 96155 (Health and behavior intervention, each 15 
minutes,face-to-face; family (without the patient present))
    This code describes a visit with a patient's family without the 
patient being present and was first included in the November 1, 2001 
final rule. It was incorrectly listed as an active code for which 
payment could be made under the physician fee schedule. Our 
longstanding payment policy is that we do not pay for visits with 
family where the patient is not present. Payment for such visits is 
included in the pre- and post-service work of a visit where the patient 
is present. Consistent with this policy, this code is not payable under 
the physician fee schedule.
    Comment: A few commenters urged us to continue to list this code as 
an active code under the fee schedule as they do not agree with our 
policy. The commenters do not agree with our assertion that payment for 
such visits is included in the pre- and post-service work of a visit 
when the patient is present and believe that not covering the service 
could result in diminished quality of care. One commenter disagreed 
that this was a technical correction since this code is currently being 
paid for under the fee schedule.
    Response: As we indicated in the proposed rule, this was 
erroneously listed as an active code, contrary to longstanding Medicare 
policy. To be consistent with our policy, no payment may be made for 
this service under Medicare, and the code will be assigned a status 
indicator of ``N''.

G. Incomplete Screening Colonoscopy

    Section 1834(d)(3) of the Act requires that the payment amount for 
a screening colonoscopy be set at the level for a

[[Page 63225]]

diagnostic colonoscopy. We have established RVUs for an incomplete 
diagnostic colonoscopy (CPT code 45378-53) However, an incomplete 
screening colonoscopy (HCPCS G0105 with modifier `53' or HCPCS G0121 
with modifier `53') is currently carrier priced. To make payment for 
screening colonoscopy consistent with payment for a diagnostic 
colonoscopy, effective January 1, 2004, Medicare will make payment for 
an incomplete screening colonoscopy, HCPCS G0105 with modifier `53' and 
HCPCS G0121 with modifier `53', at the same rate as an incomplete 
diagnostic colonoscopy (CPT 45378-53). The Medicare carriers will no 
longer manually price the practitioner payment for an incomplete 
screening colonoscopy.

H. Publication Issues

    Comment: Several commenters noted that section 1871 of the Act 
requires a 60-day public comment period. Such period traditionally 
starts with the date the proposed rule is published in the Federal 
Register. However, for the Physician Fee Schedule Proposed rule, CMS 
began the start of the 60-day comment period on August 8, the date the 
proposal was put on display at the Federal Register, rather than August 
15, the date the proposal was published in the Federal Register. The 
commenters request that CMS revert to the traditional start of the 
comment period, that is, the date of publication in the Federal 
Register. One commenter suggested that CMS should accept electronically 
submitted comments when the comment period begins earlier than the 
publication date.
    In addition, several commenters urged CMS to resolve the process 
issues associated with publishing the proposed and final rule. They 
indicated that the delayed publication of the proposed rule, combined 
with missing information from addendums and impact tables, makes review 
and analysis problematic. The commenters also expressed concern that 
CMS has insufficient time to evaluate public comments and this is 
contrary to the spirit of the Administrative Procedures Act.
    Response: CMS is keenly aware of the tight time frame between 
publication of the proposed and final rules. We make every effort to 
respond to requests from physician specialty groups and providers to 
include items in the proposed rule that affect payment levels, such as 
assigning RVUs to new CPT codes and revising RVUs for existing codes. 
It is difficult to both address numerous concerns and publish the 
proposed rule in a timely fashion. We will continue to make every 
effort to publish the proposed rule as early as possible. However, 
despite the short time frame for issuing the final rule, we take the 
review and analysis of comments very seriously. CMS devotes the 
necessary staff resources to ensure that every comment is properly 
considered.
    Furthermore, the statute does not provide that the comment period 
commences with publication in the Federal Register. Section 1871(b)(1) 
of the Act states that before issuing a regulation in final form, ``the 
Secretary shall provide for notice of the proposed regulation in the 
Federal Register and a period of not less than 60 days for public 
comment thereon.'' While the proposed rule did not actually appear in 
the Federal Register until August 15, 2003, it was filed and went on 
public display at the Federal Register several days earlier on August 
8, 2003. Accordingly, the contents of the proposed rule were, in fact, 
publicly available for the full 60-day comment period.

IV. Refinement of Relative Value Units for Calendar Year 2004 and 
Response to Public Comments on Interim Relative Value Units for 2003

A. Summary of Issues Discussed Related to the Adjustment of Relative 
Value Units

    Section IV.B of this final rule describes the methodology used to 
review the comments received on the RVUs for physician work and the 
process used to establish RVUs for new and revised CPT codes. Changes 
to codes on the physician fee schedule reflected in Addendum B are 
effective for services furnished beginning January 1, 2004. The tables 
and discussions in this section concerning the work RVUs do not reflect 
the effect of the adjustment to work RVUs to match the MEI weights as 
discussed in section VI. The referenced work RVUs may differ from the 
work RVUs in Addenda B and C that reflect this adjustment.

B. Process for Establishing Work Relative Value Units for the 2004 
Physician Fee Schedule

    Our December 31, 2002 final rule (67 FR 79966) announced the final 
work RVUs for Medicare payment for existing procedure codes under the 
physician fee schedule and interim RVUs for new and revised codes. The 
RVUs contained in the final rule applied to physician services 
furnished beginning March 1, 2003. We announced that we considered the 
RVUs for the interim codes to be subject to public comment under the 
annual refinement process. In this section, we summarize the 
refinements to the interim work RVUs published in the December 2002 
final rule and our establishment of the work RVUs for new and revised 
codes for the 2004 physician fee schedule.

C. Work Relative Value Unit Refinements of Interim Relative Value Units

1. Methodology (Includes Table titled ``Work Relative Value Unit 
Refinements of the 2003 Interim and Related Relative Value Units'')
    Although the RVUs in the December 2002 final rule were used to 
calculate 2003 payment amounts, we considered the RVUs for the new or 
revised codes to be interim. We accepted comments for a period of 60 
days. We received substantive comments from many individual physicians 
and several specialty societies on approximately 10 CPT codes with 
interim work RVUs. Only comments on codes listed in Addendum C of the 
December 2002 final rule were considered.
    To evaluate these comments we used a process similar to the process 
used in 1997. (See the October 31, 1997 final rule (62 FR 59084) for 
the discussion of refinement of CPT codes with interim work RVUs.) We 
convened a multispecialty panel of physicians to assist us in the 
review of the comments. The comments that we did not submit to panel 
review are discussed at the end of this section, as well as those that 
were reviewed by the panel. We invited representatives from the 
organization from which we received substantive comments to attend a 
panel for discussion of the code on which they had commented. The panel 
was moderated by our medical staff, and consisted of the following 
voting members:
    [sbull] One or two clinicians representing the commenting 
organization.
    [sbull] One primary care clinician nominated by the American 
College of Physicians/American Society of Internal Medicine.
    [sbull] Four carrier medical directors.
    [sbull] Four clinicians with practices in related specialties, who 
were expected to have knowledge of the service under review.
    The panel discussed the work involved in the procedure under review 
in comparison to the work associated with other services under the 
physician fee schedule. We assembled a set of 300 reference services 
and asked the panel members to compare the clinical aspects of the work 
of the service a commenter believed was incorrectly valued to one

[[Page 63226]]

or more of the reference services. In compiling the set, we attempted 
to include--(1) services that are commonly performed whose work RVUs 
are not controversial; (2) services that span the entire spectrum from 
the easiest to the most difficult; and (3) at least three services 
performed by each of the major specialties so that each specialty would 
be represented. The intent of the panel process was to capture each 
participant's independent judgment based on the discussion and his or 
her clinical experience. Following the discussion, each participant 
rated the work for the procedure. Ratings were individual and 
confidential, and there was no attempt to achieve consensus among the 
panel members.
    We then analyzed the ratings based on a presumption that the 
interim RVUs were correct. To overcome this presumption, the inaccuracy 
of the interim RVUs had to be apparent to the broad range of physicians 
participating in each panel.
    Ratings of work were analyzed for consistency among the groups 
represented on each panel. In addition, we used statistical tests to 
determine whether there was enough agreement among the groups of the 
panel and whether the agreed-upon RVUs were significantly different 
from the interim RVUs published in Addendum C of the December 2002 
final rule. We did not modify the RVUs unless there was a clear 
indication for a change. If there was agreement across groups for 
change, but the groups did not agree on what the new RVUs should be, we 
eliminated the outlier group and looked for agreement among the 
remaining groups as the basis for new RVUs. We used the same 
methodology in analyzing the ratings that we first used in the 
refinement process for the 1993 physician fee schedule. The statistical 
tests were described in detail in the November 25, 1992 final rule (57 
FR 55938).
    Our decision to convene multispecialty panels of physicians and to 
apply the statistical tests described above was based on our need to 
balance the interests of those who commented on the work RVUs against 
the redistributive effects that would occur in other specialties.
    We also received comments on RVUs that were interim for 2003, but 
for which we did not submit the RVUs to the panel for review for a 
variety of reasons. These comments and our decisions on those RVUs 
commented upon are discussed in further detail below.
    The table below lists those interim codes reviewed under the 
refinement panel process described in this section. This table includes 
the following information:
    [sbull] CPT Code. This is the CPT code for a service.
    [sbull] Description. This is an abbreviated version of the 
narrative description of the code.
    [sbull] 2003 Work RVU. The work RVUs that appeared in the December 
2002 rule are shown for each reviewed code.
    [sbull] Requested Work RVU. This column identifies the work RVUs 
requested by commenters.
    [sbull] 2004 Work RVU. This column contains the final RVUs for 
physician work. (These work RVUs may differ from the work RVUs in 
Addenda B that reflect the adjustment to work RVUs to match the MEI 
weights.)

                           Table 4.--Codes Reviewed Under the Refinement Panel Process
----------------------------------------------------------------------------------------------------------------
                                                                            2003 work    Requested    2004 work
            CPT code \1\                  Mod            Descriptor            RVU        work RVU       RVU
----------------------------------------------------------------------------------------------------------------
17310...............................  ...........  Mohs any stage  5spec each.
43219 *.............................  ...........  Esophagus endoscopy...         2.80  ...........         2.80
43256 *.............................  ...........  Uppr gi endoscopy w            4.35  ...........         4.35
                                                    stent.
44383 *.............................  ...........  Ileoscopy w/stent.....         2.94  ...........         2.94
45340...............................  ...........  Sig w/balloon dilation         1.66         1.96         1.89
51798...............................  ...........  Us urine capacity              0.00         0.38         0.00
                                                    measure.
75954...............................  ...........  Illiac aneurysm                1.36         2.93         2.25
                                                    endovas rpr.
92613...............................  ...........  Endoscopy swallow tst          0.00         0.99         0.71
                                                    (fees).
92615...............................  ...........  Eval laryngoscopy              0.00         0.88         0.63
                                                    sense test.
92617...............................  ...........  Interprt fees/                 0.00         1.10        0.79
                                                    laryngeal test.
----------------------------------------------------------------------------------------------------------------
\1\ All CPT codes and descriptions copyright 2003 American Medical Association. All rights are reserved and
  applicable FARS/DFARS clauses apply.
* The work RVUs for these codes were revised for 2003 by CMS to finalize outstanding issues related to the five-
  year review of the gastroenterology codes.

2. Interim 2003 Codes
    CPT code 17310 Chemosurgery (Mohs micrographic technique) including 
removal of all gross tumor, surgical excision of tissue specimens, 
mapping, color coding of specimens, microscopic examination of 
specimens by the surgeon, and complete histopathological preparation 
including the first routine stain (e.g. hematoxylin and eosin, 
toluidine blue); each additional specimen after the first 5 specimens, 
fixed or fresh tissue, any stage (List separately in addition to code 
for primary procedure).
    Prior to 2003, this code was reported once for all specimens over 
five generated during a particular stage of Mohs surgery. Beginning in 
2003, the code is used to report each specimen over five during a 
particular stage of Mohs surgery. The RUC recommended maintaining 0.95 
work RVUs for this code as an interim value. We disagreed and assigned 
a work value of 0.62 work RVUs to this code pending further 
recommendations from the RUC. We believed this value was appropriate 
for the new descriptor since it allows reporting of CPT code 17310 for 
each specimen rather than reporting once for all specimens. It also 
places this code in the correct rank with the other Mohs surgery 
services, CPT codes 17304-17307, and with the codes for pathology 
consultation during surgery, CPT codes 88331 and 88332.
    Commenters disagreed with the rationale we had used to arrive at 
the interim work value and indicated that we used inappropriate time/
intensity data and failed to include surgery work, focusing only on 
pathology work. Commenters also stated that the intent of this code has 
not changed and that CMS had ignored past policy which recognizes CPT 
code 17310 as an add-on service and thus allows the separate billing of 
services for each additional specimen beyond the first five. Based on 
these comments, we referred this code to the multispecialty validation 
panel for review.

[[Page 63227]]

    Final decision: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we have assigned 0.95 work 
RVUs to CPT code 17310.
    CPT Code 38204 Management of recipient hematopoietic progenitor 
cell donor search and cell acquisition.
    We disagreed with the RUC recommendation of 2.00 work RVUs for CPT 
code 38204. We believed we are already making payment for any physician 
work associated with this service as part of our payment for other bone 
marrow transplant codes (that is, CPT codes 38205, 38206, 38240, 38241, 
and 38242) and have significant concerns about how this code would be 
used in actual practice. Therefore, we assigned CPT code 38204 a status 
indicator of ``B,'' meaning that we will not make separate payment for 
this service.
    Comments: Some commenters urged us to reconsider the RUC 
recommendation. In addition, the RUC submitted a comment disagreeing 
with our contention that the physician work associated with this code 
is included in other transplant codes. The RUC also asserted that 
discussions of this issue at the RUC meetings provided substantive 
information on how this code would be used.
    Response: We continue to believe that the work of this service is 
contained in other transplant codes and are maintaining the status 
indicator of ``B.'' Therefore, we will not make separate payment for 
this service.
CPT Codes 43219 Esophagoscopy, rigid or flexible; with insertion of 
plastic tube or stent, 43256 Upper gastrointestinal endoscopy including 
esophagus, stomach, and either the duodenum and/or jejunum as 
appropriate; with transendoscopic stent placement (includes 
predilation), and 44383 Ileoscopy, through stoma; with transendoscopic 
stent placement (includes predilation).
    As explained in the December 31, 2002 final rule, the work RVUs for 
these codes were revised by CMS to finalize outstanding issues related 
to the five-year review of the gastroenterology codes. For CPT code 
43219, we maintained the work RVU of 2.80. Review of information 
supplied by specialty societies did not provide compelling evidence 
that the work RVUs should be changed. Based on a review of the 
physician time data and a comparison to other stent placement codes, we 
assigned 4.35 work RVUs to CPT code 43256 and 2.94 work RVUs to CPT 
code 44383, in order to place these services in proper rank order to 
the other stent placement codes.
    Comment: Some commenters felt that we improperly intervened in 
assigning work RVUs to these services albeit to correct rank order 
anomalies. Based on these comments we referred these codes to the 
multispecialty validation panel for review.
    Response: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we are retaining work RVUs of 
2.80 for CPT code 43219, 4.35 for CPT code 43256 and 2.94 for CPT code 
44383.
    CPT code 45335 Sigmoidoscopy, flexible; with directed submucosal 
injections any substance.
    The RUC recommended work RVUs of 1.46 for CPT code 45335 based on a 
comparison to CPT code 45330, with incremental work RVUs added to 
reflect increased pre-, intra-, and post-service work. We disagreed 
with the RUC recommendation and compared this service to the analysis 
and recommendation provided by the RUC for CPT code 43201, which is 
also a new submucosal injection code. Based on the increased risk of 
complications (resulting in higher intra-service intensities) and the 
fact that several sites are being injected instead of one, we assigned 
a work RVU of 1.36 to CPT code 45335.
    Comment: Some commenters expressed concern about the rejection of 
the RUC recommendation for this service and believed that we had 
misinterpreted the RUC findings.
    Response: Upon further review and consideration of the RUC 
recommendation we will accept the RUC recommended work RVU of 1.46 for 
this service.
    CPT Code 45340 Sigmoidoscopy, flexible; with dilation by balloon, 
each stricture.
    The RUC recommended a work RVU of 1.96 for this code, which 
includes 1.00 RVU for the incremental work based on the need for 
conscious sedation to perform this procedure. (Other flexible 
sigmoidoscopies do not require conscious sedation.) In the December 31, 
2002 rule we stated that we did not believe it is appropriate to assign 
a work RVU for CPT code 45340 that is based on the presumption that a 
portion of the work value is for the provision of conscious sedation. 
Rather, we compared the RUC recommendations for work and physician time 
for other endoscopic dilation codes to the incremental times for CPT 
code 45340 and assigned a work RVU of 1.66 to CPT code 45340.
    Comment: Some commenters urged us to accept the RUC recommendation, 
noting that our characterization of RUC recommendations on conscious 
sedation was inaccurate. The commenters stated that the RUC has 
concluded that there is an increase in the amount of physician work 
relating to conscious sedation, but has been unable to identify a 
specific numerical value for that additional increment. The RUC is in 
the process of determining the universe of codes that include conscious 
sedation as an inherent part of the service provided by the operating 
physician to ensure these services are appropriately valued. Based on 
these comments we referred this code to the multispecialty validation 
panel for review.
    Response: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we have assigned 1.89 work 
RVUs to CPT code 45340.
    CPT Code 51798 Measurement of post-voiding residual urine and/or 
bladder capacity by ultrasound, nonimaging.
    The RUC recommended 0.38 work RVUs based on a urology survey that 
reported that this procedure is performed 75 percent of the time by the 
physician and also based on a comparison of this procedure to CPT code 
76857, Ultrasound, pelvic (nonobstetric, B-scan and/or real time with 
image documentation; complete. We disagreed. This code is replacing a 
HCPCS level two code that was assigned 0.00 work RVUs because it is 
typically performed by a nurse or other clinical staff. We believed 
that CPT code 51798 is, therefore, also a nonphysician service and 
assigned 0.00 work RVUs to this service.
    Comment: Some commenters requested that we reconsider our decision 
to assign 0.00 work RVUS to this service. The commenters argued that 
our reason for disagreeing with the RUC recommendation is based on a 
stated belief that there is no physician work involved, not on actual 
survey data as presented by the American Urological Association (AUA) 
and accepted by the RUC. Commenters urged that CMS work with AUA to 
review this decision or include this code as part of the multi-
specialty validation panel for refinement of work RVUs. Based on these 
comments, we referred this code to the multispecialty validation panel 
for review.
    Response: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we will retain 0.00 work RVUs 
for CPT code 51798.
    CPT Codes 58545-58554 Laproscopic hysterectomy/myonectomy 
procedures.

[[Page 63228]]

    We accepted the RUC recommendations for work RVUs for these 
services.
    Comment: Some commenters stated that new values have been 
established for these services based on new survey data and that the 
RUC has new recommendations for these services. In their comments on 
the December 31, 2002 rule, the RUC included these new work RVU 
recommendations and urged us to review these during the refinement 
process.
    Response: We are in agreement with the RUC recommended values for 
these services. However, to provide an opportunity for public comment 
we are including these in the RUC Recommendations for New and Revised 
codes for 2004 (table xx) and will consider the RVUs interim for 2004.
    CPT code 75954 Endovascular graft placement for repair of iliac 
artery (e.g. aneurysm, pseudoaneurysm, ateriovenous malformation, 
trauma) radiological supervision and interpretation.
    The RUC agreed with the specialty societies and recommended a value 
of 2.93 work RVUs based on comparing this code to CPT codes 75952, 
Endovascular repair of infrarenal abdominal aortic anuerysm or 
dissection, radiological supervision and interpretation, (work RVU of 
4.5) and 75953, Placement of proximal or distal extension prosthesis 
for endovascular repair of infra renal abdominal aortic aneurysm, 
radiological supervision and interpretation, (work RVU of 1.36). The 
recommended RVU was midway between the RVUs of the reference 
procedures. We did not agree with the RUC recommendation. Based on the 
specialty societies' description of the work of CPT code 75954 (which 
is virtually identical to the description of the work for CPT code 
75953) and in order to maintain correct rank order in this family of 
codes, we assigned a work RVU of 1.36 to CPT code 75954.
    Comment: Some commenters expressed concern about the rejection of 
the RUC recommendation, particularly since the recommendation was based 
on data presented by several specialty societies. The commenters stated 
that the data reflected the proper rank order of this service and 
indicated that physicians in those specialties that perform ileac 
aneurysm endorepair may be in a better position to judge the 
relationship of this code to other imaging services. Based on these 
comments, we referred this code to the multispecialty validation panel 
for review.
    Response: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we have assigned 2.25 work 
RVUs to CPT code 75954.

CPT code 92610 Clinical Evaluation of swallowing function.

    In the December 2002 final rule, this CPT code replaced HCPCS code 
G0195, which had a work RVU of 1.50 in 2002. The Healthcare 
Professionals Advisory Committee (HCPAC) recommendation of a work RVU 
of 0.00 for CPT code 92610 was accepted by CMS.
    Comment: Some commenters representing the long term care industry 
expressed concern with the reduction in work for this service. The rule 
provided no explanation of the HCPAC recommendation of 0.00 work RVUs 
for this service and the commenters requested that this issue be 
addressed.
    Response: As requested by the commenters, a discussion of the HCPAC 
recommendation of 0.00 work RVUS was provided as part of the 
multispecialty validation panel, which was attended by the commenters.
CPT codes 92613 Flexible fiberoptic endoscopic evaluation of swallowing 
by cine or video recording; physician interpretation and report only, 
92615 Flexible fiberoptic endoscopic evaluation, laryngeal sensory 
testing by cine or video recording; physician interpretation and report 
only, and 92617 Flexible fiberoptic endoscopic evaluation of swallowing 
and laryngeal sensory testing by cine or video recording; physician 
interpretation and report only.
    We did not accept the RUC recommendations for work RVUs for these 
services (0.99 for 92613, 0.88 for 92615 and 1.10 for 92617) and 
assigned each of these CPT codes a work RVU of 0.00. We stated that 
these three services refer only to a separately identified physician 
review and interpretation of the fiberoptic endoscopic evaluation and 
that we consider this physician interpretation and report bundled into 
an E/M service. We stated that the physician who does not perform the 
testing should only bill for the patient when performing an E/M 
service, not as the supervisor of another professional performing and 
reviewing the initial fiberoptic endoscopic evaluation. The 
interpretation is an integral part of the testing itself and, if a 
nonphysician professional has the credentials and experience to perform 
this testing, then that professional should also provide the 
interpretation of the findings.
    Comment: Some commenters urged us to reconsider the RVUs and 
payment policies related to these services and to accept the RUC 
recommendations for these codes. The commenters asserted that the 
physician's detailed frame-by-frame analysis of the video recorded 
procedure needed to develop the diagnosis and report following this 
testing is not related to an E/M service. Rather, this is similar to 
other services where there is a report and interpretation by the 
physician that is separate from an E/M service. The commenters further 
stated that the RUC valued each procedure code and physician 
interpretation and report code separately, based on the coding 
structure created by CPT. As a result, the interpretation and reporting 
is separated from each test, and the RUC recommendations do not combine 
the interpretation with the testing. If the code were to combine the 
work of interpretation and the testing then the code descriptor would 
need to be modified and work RVUs revalued. As a final point, 
commenters disputed our assertion that a nonphysician professional with 
the credentials and experience to perform this testing should also 
provide the interpretation of the findings. Based on these comments we 
referred this code to the multispecialty validation panel for review.
    Response: As a result of the statistical analysis of the 2003 
multispecialty validation panel ratings, we have assigned 0.71 work 
RVUs to CPT code 92613; 0.63 work RVUs to CPT code 92615; 0.79 work 
RVUs to CPT code 92617.
    In the December 31, 2002 final rule (67 FR 79966), we also 
responded to the RUC recommendations on the practice expense inputs for 
the new and revised CPT codes for CY 2003. There were no comments 
received on these and therefore we are finalizing our proposals.

Late RUC Recommendations

    As we indicated in the August 15, 2003 proposed rule, RUC 
recommendations for RVUs for 23 new CPT codes for 2003 were received 
too late for incorporation in the December 31, 2002 final rule. We 
proposed interim RVUs for these codes and, as with all interim values, 
these were subject to comment. In their comments on the December 2002 
final rule, the AMA-RUC requested that we consider their late 
recommendations for these codes during refinement. Several specialties 
also requested that we consider the late RUC recommendations. We had 
considered addressing these as part of the refinement process, but 
determined that we should follow the process used for all RUC 
recommendations and solicit public comment on the valuation

[[Page 63229]]

of these services. Therefore, we are including the RVUs for codes 
listed in the table below, along with the codes that are new and 
revised for 2004, as interim for 2004. Following is a discussion of 
those codes for which did not accept the RUC recommendation.

                                                         Table 5.--2003 Late RUC Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   CMS assigned         RUC
            CPT code \1\                   Short descriptor       2003 work RVU    recommendation              CMS decision               2004 work RVU
--------------------------------------------------------------------------------------------------------------------------------------------------------
21030...............................  Excise max/zygoma b9                  3.89             4.50  Agree...............................             4.50
                                       tumor.
21040...............................  Removal of jaw bone                   3.89             4.50  Agree...............................             4.50
                                       lesion.
21742...............................  Repair sternum/nuss w/o                (2)              (2)  Agree...............................              (2)
                                       scope.
21743...............................  Repair sternum/nuss w/o                (2)              (2)  Agree...............................              (2)
                                       scope.
36511...............................  Apheresis wbc............             1.74             1.74  Agree...............................             1.74
36512...............................  Apheresis rbc............             1.74             1.74  Agree...............................             1.74
36513...............................  Apheresis platelets......             1.74             1.74  Agree...............................             1.74
36514...............................  Apheresis plasma.........             1.74             1.74  Agree...............................             1.74
36515...............................  Apheresis, adsorp/                    1.74             1.74  Agree...............................             1.74
                                       reinfuse.
36516...............................  Apheresis, selective.....             1.74             1.22  Agree...............................             1.22
38207 (Lab Codes)...................  Cryopreserve stem cells..              (3)             0.47  Disagree............................              (4)
38210 (Lab Codes)...................  T-cell depletion of                    (3)             0.94  Disagree............................              (4)
                                       harvest.
38211 (Lab Codes)...................  Tumor cell deplete of                  (3)             0.71  Disagree............................              (4)
                                       harvest.
38212 (Lab Codes)...................  Rbc depletion of harvest.              (3)             0.47  Disagree............................              (4)
38213 (Lab Codes)...................  Platelet deplete of                    (3)             0.24  Disagree............................              (4)
                                       harvest.
38214 (Lab Codes)...................  Volume deplete of harvest              (3)             0.24  Disagree............................              (4)
38215 (Lab Codes)...................  Harvest Stem cell                      (3)             0.55  Disagree............................              (4)
                                       concentrate.
93784...............................  Ambulatory BP monitoring.             0.17             0.38  Agree...............................             0.38
93786...............................  Ambulatory BP recording..             0.00             0.00  Agree...............................             0.00
93788...............................  Ambulatory BP analysis...              (5)             0.00  Agree...............................             0.00
93790...............................  Review/report BP                      0.17             0.38  Agree...............................            0.38
                                       recording.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All CPT codes and descriptions copyright 2003 American Medical Association. All rights are reserved and applicable FARS/DFARS clauses apply.
\2\ Carrier Priced.
\3\ Assigned Status Indicator of ``I''.
\4\ Maintain Status Indicator of ``I''.
\5\ Assigned Status Indicator of ``N''



[[Page 63230]]

    Note : CPT codes 38208, 38209 and 95990 are addressed later in 
this section (new and revised codes for 2004)and are also included 
in table 4. Also these work RVUs may differ from the work RVUs in 
Addenda B and C that reflect the adjustment to match the MEI 
weights.

CPT codes 38207 Transplant preparation of hematopoietic progenitor 
cells; cryopreservation and storage, 38210 Transplant preparation of 
hematopoietic progenitor cells; specific cell depletion within harvest, 
T-cell depletion, 38211 Transplant preparation of hematopoietic 
progenitor cells; tumor cell depletion, 38212 Transplant preparation of 
hematopoietic progenitor cells; red blood cell removal, 38213 
Transplant preparation of hematopoietic progenitor cells; platelet 
depletion, 38214 Transplant preparation of hematopoietic progenitor 
cells; plasma (volume) depletion, 38215 Transplant preparation of 
hematopoietic progenitor cells; cell concentration in plasma, 
mononuclear, or buffy coat layer.
    We continue to have the same concerns as outlined in the December 
31, 2002 final rule (67 FR 80007) with respect to moving these codes 
off of the laboratory fee schedule. We are maintaining a status 
indicator ``I'' for these services making them not valid for Medicare 
purposes.
    CPT Codes 93784 Ambulatory blood pressure monitoring, utilizing a 
system such as magnetic tape and/or computer disk, for 24 hours or 
longer; including recording, scanning analysis, interpretation and 
report, 93786 Ambulatory blood pressure monitoring, utilizing a system 
such as magnetic tape and/or computer disk, for 24 hours or longer; 
recording only, 93788 Ambulatory blood pressure monitoring, utilizing a 
system such as magnetic tape and/or computer disk, for 24 hours or 
longer; scanning analysis with report, and 93790 Ambulatory blood 
pressure monitoring, utilizing a system such as magnetic tape and/or 
computer disk, for 24 hours or longer; physician review with 
interpretation and report.
    The RUC recommendations for these codes were received too late for 
inclusion in the 2003 final rule. We had established the following work 
RVUs for these services during 2002 in response to a national coverage 
determination: CPT code 93784-0.17 work RVUs; 93786-0.00 work RVUs; 
93790-0.17 work RVUs and had indicated that CPT code 93788 was not 
covered. We stated we would maintain these work RVUs until we receive a 
RUC recommendation.
    Comment: Some commenters urged us to consider the RUC 
recommendations during the refinement process and also questioned the 
noncovered status of CPT code 93788. CPT codes 93786 and 93788 are two 
separate codes for the technical component and the coding format is 
identical to the coding used for Holter monitoring, which also has two 
codes for the TC of the service. Commenters also requested that CPT 
code 93788 be listed as a covered service.
    Response: We are accepting the RUC recommendation of 0.38 work RVUs 
for CPT codes 93784 and 93790 and 0.00 work RVUs for CPT code 93786. We 
have reviewed the issue of noncoverage of CPT code 93788 and based upon 
the information provided by the commenters will recognize CPT code 
93788 for coverage and payment under the physician fee schedule. We are 
also accepting the RUC recommendation of 0.00 for CPT code 93788.
    We received the following comments on HCPCS codes established in 
the December 31, 2002 final rule.
    GO262 Small intestinal imaging; intraluminal, from ligament of 
Treitz to the ileocecal valve, includes physician interpretation and 
report.
    We created this code to describe a new diagnostic test for which we 
will make separate payment under the physician fee schedule. We 
assigned a work RVU of 2.12 to the code based on a comparison to the 
work of other diagnostic tests and procedures that require review of 
significant amounts of data.
    Comment: Some commenters stated that that the time we used to 
establish the work RVU was greatly underestimated and may have been 
based on a misunderstanding of some of the time data contained in 
published literature. Based on limited survey data of physicians 
performing this procedure and comparison to the intensity of other 
services, commenters recommended a work RVU of 7.80.
    Response: We are deleting HCPCS code G0262 since there is a new CPT 
code 91110, Gastrointestinal tract imaging, intraluminal (e.g., capsule 
endoscopy), esophagus through ileum, with physician interpretation and 
report, which will be used to report this service in 2004. We note that 
we accepted the RUC recommendation of 3.65 work RVUs for CPT 91110. If 
the commenters do not agree with the valuation of this service they may 
submit comments on this issue.
GO268 Removal of impacted cerumen (one or both ears) by physician on 
same date of service as audiologic function testing.
    This code was created to allow payment to a physician who removes 
impacted cerumen on the same date as his or her employed audiologist 
performs audiologic function testing. We noted that routine removal of 
cerumen is not paid separately, because it is considered to be part of 
the procedure with which it is billed (for example, audiologic function 
testing). This code is to be used only in those unusual circumstances 
when an employed audiologist who bills under a physician uniform 
provider identifier number (UPIN) performs audiologic function testing 
on the same day as removal of impacted cerumen requiring physician 
expertise for removal. This code should not be used when the 
audiologist removes cerumen, because removal of cerumen is considered 
to be part of the diagnostic testing and is not paid separately.
    Comment: Commenters stated that creation of this G code was 
problematic because there could be many other ``incident to'' services 
in which a physician performs a separate medically necessary procedure, 
that, if less extensive, would be considered to be included in a 
nonphysician provider service. The commenters suggested that a modifier 
could be used to describe this situation, avoiding the creation of a G 
code.
    Response: We disagree and believe that this is a unique situation 
that is most appropriately handled through the use of a G code.
GO269 Placement of occlusive device into either a venous or arterial 
access site, post surgical or interventional procedure (e.g., angioseal 
plug, vascular plug.)
    We created this code due to the inappropriate reporting of this 
service with codes for such procedures as ``blood vessel repair'' and 
``repair of arterial pseudoaneurysm'', and indicated that there would 
be no separate payment for this service as the work, practice expense, 
and malpractice risk is included in the main invasive procedure.
    Comment: Commenters disagreed with the creation of this G code 
because it is intended to report a service that is a required component 
of another service and believed that the creation of this code may lead 
to the creation of many codes for reporting inclusive procedures 
separately. Some commenters suggested that the creation of 
parenthetical

[[Page 63231]]

instructions in CPT to instruct that ``referenced procedures (i.e., 
blood vessel repair, repair of arterial pseudoaneurysm) would not be 
appropriately reported in addition to the interventional vascular 
procedure'' would address our concerns. Other commenters disagreed with 
our assertion that closure devices are included in the practice expense 
payment, as such devices are not typically used in every interventional 
or surgical case. Commenters suggested this code be a technical 
component service only and have RVUs commensurate with the cost of the 
device.
    Response: As we indicated in the December 31, 2002, final rule, 
this code was created to address a specific concern about inappropriate 
reporting of this service using such procedures as ``blood vessel 
repair'' and ``repair of arterial pseudoaneurysm.'' Since this service 
is considered part of the main invasive procedure, to the extent this 
is typically part of the invasive procedure, it is accounted for under 
the practice expense methodology. We will continue to consider this 
code bundled for Medicare purposes, that is, no separate payment will 
be made under the physician fee schedule.
GO272 Naso/oro gastric tube placement, requiring physician's skill and 
fluoroscopic guidance (includes fluoroscopy, image documentation and 
report)
    We indicated we were creating this code for use until an identical 
CPT code can become effective. We assigned this code a work RVU of 
0.32.
    Comment: Commenters disagreed with the 0.32 value assigned to this 
service and recommended that we replace the work RVUs with the RUC 
recommended work value for CPT code 43752.
    Response: We are deleting HCPCS code G0272 and CPT code 43752, 
Naso-or oro-gastric tube placement, requiring physician's skill and 
fluoroscopic guidance (includes fluoroscopy, image documentation and 
report), will be used to report this service.
GO273 Radiopharmaceutical biodistribution, single or multiple scans on 
one or more days, pre-treatment planning for radiopharmaceutical 
therapy of non-Hodgkin's lymphoma, includes administration of 
radiopharmaceutical (e.g., radiolabeled antibodies) and GO274 
Radiopharmaceutical therapy, non-Hodgkin's lymphoma, includes 
administration of radiopharmaceutical (e.g., radiolabeled antibodies)
    We created G0273 to describe radionuclide scanning to determine the 
biodistribution of Zevulin. We assigned 0.86 work RVUs to this code 
based on a comparison to CPT code 78802, Radiopharmaceutical 
localization of tumor; whole body. We established G0274 to allow 
appropriate reporting of this new service and assigned a work RVU of 
2.07 to this code.
    Comment: Commenters urged us to reevaluate the RVUs assigned to 
these codes and expressed concern that a lack of understanding about 
this service has led to its inappropriate valuation. Additionally, 
commenters requested that we present these codes to the AMA for 
consideration by the CPT Editorial Panel and RUC.
    Response: We are deleting HCPCS codes G0273 and G0274. CPT codes 
79403, Radiopharmaceutical therapy, radiolabeled monoclonal antibody by 
intravenous infusion, and 78802, Radiopharmaceutical localization of 
tumor or distribution of radiopharmaceutical agent(s); whole body 
single day imaging, will be used to report these services.
GO275 Renal artery angiography (unilateral or bilateral) performed at 
the time of cardiac catheterization, includes catheter placement in the 
renal artery, injection of dye, flush aortogram and radiologic 
supervision and interpretation and production of images (List 
separately in addition to primary procedure) and GO278 Iliac artery 
angiography performed at the same time of cardiac catheterization, 
includes catheter placement, injection of dye, radiologic supervision 
and interpretation and production of images (List separately in 
addition to primary procedure)
    We created these add-on codes to assure proper reporting of and 
payment for renal and iliac angiography performed at the time of 
cardiac angiography. We determined the work value of 0.25 for these two 
add-on procedures by using the work values for CPT codes 75625, 
Aortography, abdominal, by serialography, radiological supervision and 
interpretation and 93544 Injection procedure during cardiac 
catherization; for aortography and adjusting for the procedure time.
    Comment: Commenters suggested that, if the true intention for the 
creation of G0275 was to assure correct coding of selective renal 
angiography performed in conjunction with cardiac catheterization, the 
RVUs are too low and not commensurate with the work associated with 
selective unilateral and/or bilateral renal angiography. However, if 
CMS'' intention for G0275 is non-selective renal angiography, then this 
should be stated clearly in the code descriptor. Commenters also 
considered the work RVUs assigned to G0278 to be too low. If G0278 is 
meant to be a selective procedure, then the work RVU should take into 
consideration the selective catheterization codes (CPT codes 36425 and 
36425) and associated imaging codes (CPT codes 75710 and 75716).
    Response: As announced in Program Memorandum, Transmittal AB-03-
119, Change Request 2853) issued August 8, 2003, the descriptors for 
these two services specify that they apply to non-selective angiography 
and have been revised as follows:
GO275 Renal artery angiography, non-selective, one or both kidneys, 
performed at the time of cardiac catheterization and/or coronary 
angiography, includes positioning or placement of any catheter in the 
abdominal aorta at or near the origins (ostia) of the renal arteries, 
injection of dye, flush aortogram, production of permanent images, and 
radiologic supervision and interpretation (List separately in addition 
to primary procedure). and
GO278 Iliac and/or femoral artery angiography, non-selective, bilateral 
or ipsilateral to catheter insertion, performed at the same time as 
cardiac catheterization and/or coronary angiography, includes 
positioning or placement of the catheter in the distal aorta or 
ipsilateral femoral or iliac artery, inkjecton of dye, production of 
permanent images, and radioogic supervision and interpretation (List 
separately in addition to primary procedure). We will be retaining the 
work RVU of 0.25 for these two codes.
GO279 Extracorporeal shock wave therapy; involving elbow epicondylitis
GO280 Extracorporeal shock wave therapy; involving other than elbow 
epicondylitis or plantar fascitis
    In the December 31, 2002 final rule we incorrectly established RVUs 
for CPT code 0020T, Extracorporeal shock

[[Page 63232]]

wave therapy; involving musculoskeletal system, which is an emerging 
technology code and also created two new HCPCS codes (G0279 and G0280) 
with payments based on our valuation of this CPT code. In the August 
15, 2003 proposed rule we also requested additional information on 
these services.
    Comment: Commenters on the December 2002 rule indicated that 
assignment of RVUs for CPT code 0020T is contrary to national policy 
established in the November 1, 2001 (66 FR 55269) final rule. They also 
indicated that the assumptions used to assign RVUs to these services 
were incorrect and undervalued these services.
    Response: In a correction notice published May 30, 2003 (68 FR 
32400) we indicated that we had incorrectly assigned RVUs to these 
services and they would be carrier priced.
    Comment: Commenters on the December 2002 rule expressed concern 
that the G codes were not reflective of the changes in technology and 
FDA approval of ESWT. Commenters also disagreed with our categorization 
and portrayal of CPT 0020T as a procedure similar to other physical 
therapy modalities. Commenters urged us to correct and clarify that CPT 
0020T is not physical therapy service but a physician procedure and 
thus should be removed from the list of codes identifying certain 
designated health services.
    Response: We understand that this is a changing technology and 
believe the current descriptors accommodate these changes. We are 
removing CPT 0020T from the list of designated health services in 
Addendum F since we agree that, at this time, this service is 
predominantly performed by medical specialties such as orthopedists and 
podiatrists.
    Comment: Commenters on the August 15, 2003 proposed rule urged us 
to continue to have these services priced by the carrier and expressed 
concern that our request for additional information indicated we would 
be establishing national payment amounts for these services. In 
addition, several physicians provided information on how this service 
is used in their offices, including cost information as well as a 
description of the procedure. Some commenters recommended that separate 
G codes be established to differentiate between the high and low energy 
levels that are currently used, as this impacts the treatment protocols 
as well as the resources used in these procedures.
    Response: The purpose for soliciting information in the proposed 
rule was to gain a better understanding of the use of the various 
systems as well as the resources involved with this procedure. We 
appreciate the information the commenters provided and will continue to 
review this issue to determine if coding changes are warranted. We are 
retaining the current codes, G0279, G0280 and CPT code 0020T under the 
fee schedule and these will continue to be carrier priced. We believe 
this will enable the carriers to make appropriate payment for these 
services based on resources used. In addition, as previously discussed, 
we are removing CPT code 0020T from the list of designated health 
services in Addendum F.
    GO288 Reconstruction, computed tomographic angiography of aorta for 
surgical planning for vascular surgery.
    We created this code, which is a technical component code, to 
assure accurate reporting of this service by independent diagnostic 
testing facilities (IDTFs) that perform this service. This service 
includes receipt of a Computed Tomographic Angiogram (CTA), post-CTA 
processing using specialized software, and burning the 3D model onto a 
CD and returning it to the operating surgeon. This 3D only model is 
used to assist vascular surgeons in planning for, or monitoring the 
results of, endovascular aneurysm repair. The service is a technical 
service provided under the general supervision of a physician according 
to the supervision requirements for IDTFs.
    Comment: Commenters requested clarification on whether this code 
could be used for the treatment planning both prior to surgery as well 
as for post-surgical monitoring. They also indicated that it should be 
expanded to include the use of enhanced computed tomography scans or 
magnetic resonance images and not just those generated by CTA. In 
addition, one commenter suggested that CMS ensure that this HCPCS code 
is used only for those technologies that meet the following criteria: 
(1) The ability to perform precise modeling of multiple clinically-
relevant objects; (2) the ability to generate specific measurements 
essential for surgical planning and follow-up; (3) built-in quality 
control and self-validation capabilities; (4) FDA marketing clearance 
for use in surgical planning and follow-up treatment; and (5) 
conformance to standards adopted by the International Standards of 
Organization (ISO).
    Commenters also suggested that the payment for this code be revised 
so that it is more in line with the payment for these services when 
administered in the outpatient setting.
    Response: We agree that this service can be used for treatment 
planning prior to surgery as well as for post-surgical monitoring and 
have revised the code descriptor to clarify this point. The descriptor 
for this code is revised as follows:
    G0288 Reconstruction, computed tomographic angiography of aorta for 
preoperative planning and evaluation post vascular surgery.
    However, we are not expanding this service to include the use of 
enhanced computed tomography scans or magnetic resonance, as we have 
not been presented with information to support its use with these other 
data sources. We assume that physicians providing this service will 
abide by the FDA labeling requirements for the specific equipment used. 
Payment for services under the outpatient prospective payment system is 
based on a different methodology than services paid under the physician 
fee schedule. As required by section 1848 of the Act, payment under the 
physician fee schedule is based on national relative value units based 
on resources used in furnishing the service. We believe the RVUs 
established for this service are reflective of the resources used, and 
therefore do not believe this should be carrier priced.
    GO289 Arthroscopy, knee, surgical, for removal of loose body, 
foreign body, debridement/shaving of articular cartilage 
(chrondroplasty) at the time of other surgical knee arthroscopy in a 
different compartment of the same knee.
    We created this add-on code to permit appropriate reporting of 
arthroscopic procedures performed in different compartments of the same 
knee during the same operative session. We stated that this code should 
be reported only when the physician spends at least 15 minutes in the 
additional compartment performing the procedure. It should not be 
reported if the reason for performing the procedure is due to a problem 
caused by the arthroscopic procedure itself. We noted that this code is 
to be used when a procedure is performed in the lateral, medial, or 
patellar compartments in addition to the main procedure. We assigned a 
work RVU of 1.48 to this code RVUs based on a comparison to CPT codes 
29874, 29877 and 29870, the base procedure for this family of codes.
    Comment: Commenters appreciated our efforts to address the issue of 
reimbursement for this procedure. However, they expressed concern about 
the specific reference to a 15 minute time requirement. The commenters 
believed that this was inappropriate because using time in this manner

[[Page 63233]]

rewards and encourages inefficient work and penalizes efficient 
physicians, which ultimately has an impact on the quality of care 
delivered to Medicare beneficiaries.
    Response: We understand the concerns expressed by the commenters 
and regret any confusion that the time reference may have created. This 
reference to time was intended as a guideline to ensure that this add-
on code is used only when the procedure performed is a substantive 
procedure needed to produce a significant improvement in the patient's 
condition. Documentation supporting this should be reflected in the 
operative note.
    Establishment of Interim Work Relative Value Units for New and 
Revised Physician's Current Procedural Terminology (CPT) Codes and New 
Healthcare Common Procedure Coding System Codes (HCPCS) for 2004 
(Includes Table titled American Medical Association Specialty Relative 
Value Update Committee and Health Care Professionals Advisory Committee 
Recommendations and CMS's Decisions for New and Revised 2004 CPT Codes)
    One aspect of establishing RVUs for 2004 was related to the 
assignment of interim work RVUs for all new and revised CPT codes. As 
described in our November 25, 1992 notice on the 1993 physician fee 
schedule (57 FR 55983) and in section III.B. of the November 22, 1996 
final rule (61 FR 59505 through 59506), we established a process, based 
on recommendations received from the AMA's RUC, for establishing 
interim work RVUs for new and revised codes.
    This year we received work RVU recommendations for approximately 
132 new and revised CPT codes from the RUC. Our staff and medical 
officers reviewed the RUC recommendations by comparing them to our 
reference set or to other comparable services for which work RVUs had 
previously been established, or to both of these criteria. We also 
considered the relationships among the new and revised codes for which 
we received RUC recommendations. We agreed with the majority of the 
relative relationships reflected in the RUC values. In some instances, 
when we agreed with the relationships, we nonetheless revised the work 
RVUs to achieve work neutrality within families of codes. That is, the 
work RVUs have been adjusted so that the sum of the new or revised work 
RVUs (weighted by projected frequency of use) for a family will be the 
same as the sum of the current work RVUs (weighted by projected 
frequency of use). We reviewed all the RUC recommendations. We accepted 
approximately 95 percent and we disagreed with approximately 5 percent 
of the RUC recommended values. In the majority of these instances, we 
agreed with the relativity established by the RUC, but needed to adjust 
work RVUs to retain budget neutrality.
    We received 2 recommendations from the HCPAC. We agreed with both 
of the HCPAC recommendations.
    Table 5, titled ``AMA RUC and HCPAC Recommendations and CMS 
Decisions for New and Revised 2004 CPT Codes'', lists the new or 
revised CPT codes, and their associated work RVUs, that will be interim 
in 2004. This table includes the following information:
    [sbull] A ``'' identifies a new code for 2004.
    [sbull] CPT code. This is the CPT code for a service.
    [sbull] Modifier. A ``26'' in this column indicates that the work 
RVUs are for the professional component of the code.
    [sbull] Description. This is an abbreviated version of the 
narrative description of the code.
    [sbull] RUC recommendations. This column identifies the work RVUs 
recommended by the RUC.
    [sbull] HCPAC recommendations. This column identifies the work RVUs 
recommended by the HCPAC.
    [sbull] CMS decision. This column indicates whether we agreed with 
the RUC recommendation (``agree'') or we disagreed with the RUC 
recommendation (``disagree''). Codes for which we did not accept the 
RUC recommendation are discussed in greater detail following this 
table. An ``(a)'' indicates that no RUC recommendation was provided.
    [sbull] 2004 Work RVUs. This column establishes the 2004 work RVUs 
for physician work. These work RVUs may differ from the work RVUs in 
Addenda B and C that reflect the adjustments to work RVUs to match the 
MEI weights.

        Table 6.--AMA RUC and HCPAC Recommendations and CMS Decisions for New and Revised 2004 CPT Codes
----------------------------------------------------------------------------------------------------------------
                                                         RUC            HCPAC                         2004 work
    * CPT code          Mod         Description    recommendation  recommendation    CMS decision        RVU
----------------------------------------------------------------------------------------------------------------
20982....  ...........  Ablate, bone               7.27   ..............  Agree...........         7.27
                                  tumor(s) perq.
21685....  ...........  Hyoid myotomy &           13.00   ..............  Agree...........        13.00
                                  suspension.
22532....  ...........  Lat thorax spine          24.00   ..............  Agree...........        24.00
                                  fusion.
22533....  ...........  Lat lumbar spine          23.12   ..............  Agree...........        23.12
                                  fusion.
22534....  ...........  Lat thor/lumb,             6.00   ..............  Agree...........         6.00
                                  add'l seg.
31622.............  ...........  Dx bronchoscope/           2.78   ..............  Agree...........         2.78
                                  wash.
31623.............  ...........  Dx bronchoscope/           2.88   ..............  Agree...........         2.88
                                  brush.
31624.............  ...........  Dx bronchoscope/           2.88   ..............  Agree...........         2.88
                                  lavage.
31625.............  ...........  Bronchoscopy w/            3.37   ..............  Agree...........         3.37
                                  biopsy (s).
31628.............  ...........  Bronchoscopy/              3.81   ..............  Agree...........         3.81
                                  lung bx, each.
31629.............  ...........  Bronchoscopy/              4.10   ..............  Agree...........         4.10
                                  needle bx, each.
31630.............  ...........  Bronchoscopy               3.82   ..............  Agree...........         3.82
                                  dilate/fx repr.
31631.............  ...........  Bronchoscopy,              4.37   ..............  Agree...........         4.37
                                  dilate w/stent.
31632....  ...........  Bronchoscopy/              1.03   ..............  Agree...........         1.03
                                  lung bx, add'l.
31633....  ...........  Bronchoscopy/              1.32   ..............  Agree...........         1.32
                                  needle bx add'l.
31635.............  ...........  Bronchoscopy w/            3.68   ..............  Agree...........         3.68
                                  fb removal.
31640.............  ...........  Bronchoscopy w/            4.94   ..............  Agree...........         4.94
                                  tumor excise.
33310.............  ...........   Exploratory              18.51   ..............  Agree...........        18.51
                                  heart surgery.
33315.............  ...........   Exploratory              22.37   ..............   Agree..........        22.37
                                  heart surgery.
34805....  ...........  Endovasc abdo             21.88   ..............  Agree...........        21.88
                                  repair w/pros.
35510....  ...........  Artery bypass             23.00   ..............  Agree...........        23.00
                                  graft.
35512....  ...........  Artery bypass             22.50   ..............  Agree...........        22.50
                                  graft.
35522....  ...........  Artery bypass             21.76   ..............  Agree...........        21.76
                                  graft.
35525....  ...........  Artery bypass             20.63   ..............  Agree...........        20.63
                                  graft.
35697....  ...........  Reimplant artery           3.00   ..............  Agree...........         3.00
                                  each.

[[Page 63234]]


36555....  ...........  Insert non-                2.68   ..............  Agree...........         2.68
                                  tunnel cv cath.
36556....  ...........  Insert non-                2.50   ..............  Agree...........         2.50
                                  tunnel cv cath.
36557....  ...........  Insert tunneled            5.10   ..............  Agree...........         5.10
                                  cv cath.
36558....  ...........  Insert tunneled            4.80   ..............  Agree...........         4.80
                                  cv cath.
36560....  ...........  Insert tunneled            6.25   ..............  Agree...........         6.25
                                  cv cath.
36561....  ...........  Insert tunneled            6.00   ..............  Agree...........         6.00
                                  cv cath.
36563....  ...........  Insert tunneled            6.20   ..............  Agree...........         6.20
                                  cv cath.
36565....  ...........  Insert tunneled            6.00   ..............  Agree...........         6.00
                                  cv cath.
36566....  ...........  Insert tunneled            6.50   ..............  Agree...........         6.50
                                  cv cath.
36568....  ...........  Insert tunneled            1.92   ..............  Agree...........         1.92
                                  cv cath.
36569....  ...........  Insert tunneled            1.82   ..............  Agree...........         1.82
                                  cv cath.
36570....  ...........  Insert tunneled            5.32   ..............  Agree...........         5.32
                                  cv cath.
36571....  ...........  Insert tunneled            5.30   ..............  Agree...........         5.30
                                  cv cath.
36575....  ...........  Repair tunneled            0.67   ..............  Agree...........         0.67
                                  cv cath.
36576....  ...........  Repair tunneled            3.19   ..............  Agree...........         3.19
                                  cv cath.
36578....  ...........  Repair tunneled            3.50   ..............  Agree...........         3.50
                                  cv cath.
36580....  ...........  Replace tunneled           1.31   ..............  Agree...........         1.31
                                  cv cath.
36581....  ...........  Replace tunneled           3.44   ..............  Agree...........         3.44
                                  cv cath.
36582....  ...........  Replace tunneled           5.20   ..............  Agree...........         5.20
                                  cv cath.
36583....  ...........  Replace tunneled           5.25   ..............  Agree...........         5.25
                                  cv cath.
36584....  ...........  Replace tunneled           1.20   ..............  Agree...........         1.20
                                  cv cath.
36585....  ...........  Replace tunneled           4.80   ..............  Agree...........         4.80
                                  cv cath.
36589....  ...........  Removal tunneled           2.27   ..............  Agree...........         2.27
                                  cv cath.
36590....  ...........  Removal tunneled           3.30   ..............  Agree...........         3.30
                                  cv cath.
36595....  ...........  Mech remov                 3.60   ..............  Agree...........         3.60
                                  tunneled cv
                                  cath.
36596....  ...........  Mech remov                 0.75   ..............  Agree...........         0.75
                                  tunneled cv
                                  cath.
36597....  ...........  Repositoin                 1.21   ..............  Agree...........         1.21
                                  venous catheter.
36838....  ...........  Dist revas                20.63   ..............  Agree...........        20.63
                                  ligation, hemo.
37765....  ...........  Phleb veins--              7.35   ..............  Agree...........         7.35
                                  extrem--to 20.
37766....  ...........  Phleb veins--              9.30   ..............  Agree...........         9.30
                                  extrem 20 +.
37785.............  ...........  Ligate/divide/             3.84   ..............  Agree...........         3.84
                                  excise vein.
38208.............  ...........  Thaw preserved             0.56   ..............  Disagree........         0.00
                                  stem cells.
38209.............  ...........  Wash harvest               0.24   ..............  Disagree........         0.00
                                  stem cells.
43235.............  ...........  Uppr gi                    2.39   ..............  Agree...........         2.39
                                  endoscopy,
                                  diagnosis.
43237....  ...........  Endoscopic us              3.99   ..............  Agree...........         3.99
                                  exam, esoph.
43238....  ...........  Uppr gi                    5.03   ..............  Agree...........         5.03
                                  endoscopy w/us
                                  fn bx.
43242.............  ...........  Uppr gi                    7.31   ..............  Agree...........         7.31
                                  endoscopy w/us
                                  fn bx.
43259.............  ...........  Endoscopic                 5.20   ..............  Agree...........         5.20
                                  ultrasound exam.
43752.............  ...........  Nasal/orogastric           0.82   ..............  Disagree........         0.68
                                  w/stent.
47133.............  ...........  Removal of donor       [dagger]   ..............  Agree...........     [dagger]
                                  liver.
47140....  ...........  Partial removal,          55.00   ..............  Agree...........        55.00
                                  donor liver.
47141....  ...........  Partial removal,          67.50   ..............  Agree...........        67.50
                                  donor liver.
47142....  ...........  Partial removal,          75.00   ..............  Agree...........        75.00
                                  donor liver.
53500....  ...........  Urethrlys,                12.21   ..............  Agree...........        12.21
                                  transvag w/
                                  scope.
57425....  ...........  Laparoscopy,              15.75   ..............  Agree...........        15.75
                                  surg, colpopexy.
58545.............  ...........  Laparoscopic              14.21   ..............  Agree...........        14.21
                                  myomectomy.
58546.............  ...........  Laparo-                   19.00   ..............  Agree...........        19.00
                                  myomectomy,
                                  complex.
58550.............  ...........  Laparo-asst vag           14.19   ..............  Agree...........        14.19
                                  hysterectomy.
58552.............  ...........  Laparo-vag hyst           16.00   ..............  Agree...........        16.00
                                  incl t/o.
58553.............  ...........  Laparo-vag hyst,          20.00   ..............  Agree...........        20.00
                                  complex.
58554.............  ...........  Laparo-vag hyst           22.00   ..............  Agree...........        22.00
                                  w/t/o, compl.
59070....  ...........  Transabdom                 5.25   ..............  Agree...........         5.25
                                  amnioinfus w/us.
59072....  ...........  Umbilical cord             9.00   ..............  Agree...........         9.00
                                  occlud w/us.
59074....  ...........  Fetal fluid                5.25   ..............  Agree...........         5.25
                                  drainage w/us.
59076....  ...........  Fetal shunt                9.00   ..............  Agree...........         9.00
                                  placement, w/us.
59897....     [dagger]  Fetal invas px w/      [dagger]   ..............  Agree...........     [dagger]
                                  us.
61537....  ...........  Removal of brain          25.00   ..............  Agree...........        25.00
                                  tissue.
61538.............  ...........  Removal of brain          26.81   ..............  Agree...........        26.81
                                  tissue.
61539.............  ...........  Removal of brain          32.08   ..............  Agree...........        32.08
                                  tissue.
61540....  ...........  Removal of brain          30.00   ..............  Agree...........        30.00
                                  tissue.
61543.............  ...........  Removal of brain          29.22   ..............  Agree...........        29.22
                                  tissue.
61566....  ...........  Removal of brain          31.00   ..............  Agree...........        31.00
                                  tissue.
61567....  ...........  Incision of               35.50   ..............  Agree...........        35.50
                                  brain tissue.
61863....  ...........  Implant                   19.00   ..............  Disagree........        13.92
                                  neuroelectrode.
61864....  ...........  Implant                    4.50   ..............  Agree...........         4.50
                                  neuroelectrode,
                                  add'l.
61867....  ...........  Implant                   31.34   ..............  Disagree........        22.96
                                  neuroelectrode.
61868....  ...........  Implant                    7.92   ..............  Agree...........         7.92
                                  neuroelectrde,
                                  add'l.
63101....  ...........  Removal of                32.00   ..............  Agree...........        32.00
                                  vertebral boby.
63102....  ...........  Removal of                32.00   ..............  Agree...........        32.00
                                  vertebral body.

[[Page 63235]]


63103....  ...........  Removal                    5.00   ..............  Disagree........         3.90
                                  vertebral body
                                  add-on.
64449....  ...........  N block inj,               3.00   ..............  Agree...........         3.00
                                  lumbar plexus.
64517....  ...........  N block inj,               2.20   ..............  Agree...........         2.20
                                  hypogas plxs.
64680.............  ...........  Injection                  2.62   ..............  Agree...........         2.62
                                  treatment of
                                  nerve.
64681....  ...........  Injection                  3.55   ..............  Agree...........         3.55
                                  treatment of
                                  nerve.
65780....  ...........  Ocular reconst,           10.25   ..............  Agree...........        10.25
                                  transplant.
65781....  ...........  Ocular reconst,           17.67   ..............  Agree...........        17.67
                                  transplant.
65782....  ...........  Ocular reconst,           15.00   ..............  Agree...........        15.00
                                  transplant.
67912....  ...........  Correction                 5.68   ..............  Agree...........         5.68
                                  eyelid w/
                                  implant.
68371....  ...........  Harvest eye                4.90   ..............  Agree...........         4.90
                                  tissue,
                                  alograft.
70557....  ...........  Mri brain w/o              2.90   ..............  Agree...........         2.90
                                  dye.
70558....  ...........  Mri brain w/dye.           3.20   ..............  Agree...........         3.20
70559....  ...........  Mri brain w/o &            3.20   ..............  Agree...........         3.20
                                  w/dye.
75901.............  ...........  Remove cva                 0.49   ..............  Agree...........         0.49
                                  device obstruct.
75902.............  ...........  Remove cva lumen           0.39   ..............  Agree...........         0.39
                                  obstruct.
75998....  ...........  Fluoroguide for            0.38   ..............  Agree...........         0.38
                                  vein device.
76082....  ...........  Computer                   0.06   ..............  Agree...........         0.06
                                  mammogram add-
                                  on.
76083....  ...........  Computer                   0.06   ..............  Agree...........         0.06
                                  mammogram add-
                                  on.
76514....  ...........  Echo exam of               0.17   ..............  Agree...........         0.17
                                  eye, thickness.
76937....  ...........  Us guide,                  0.30   ..............  Agree...........         0.30
                                  vascular access.
78800.............  ...........  Tumor imaging,             0.66   ..............  Agree...........         0.66
                                  limited area.
78801.............  ...........  Tumor imaging,             0.79   ..............  Agree...........         0.79
                                  mult areas.
78802.............  ...........  Tumor imaging,             0.86   ..............  Agree...........         0.86
                                  whole body.
78803.............  ...........  Tumor imaging              1.09   ..............  Agree...........         1.09
                                  (3D).
78804....  ...........  Tumor imaging,             1.07   ..............  Agree...........         1.07
                                  whole body.
79100.............  ...........  Repeat                     1.32   ..............  Agree...........         1.32
                                  hyperthyroid
                                  therapy.
79400.............  ...........  Nonhemato                  1.96   ..............  Agree...........         1.96
                                  nuclear therapy.
79403....  ...........  Hematopoetic               2.25   ..............  Agree...........         2.25
                                  nuclear therapy.
85396....  ...........  Clotting assay,            0.37   ..............  Agree...........         0.37
                                  whole blood.
88112....  ...........  Cytopath, cell             1.18   ..............  Agree...........         1.18
                                  enhance blood.
88342.............  ...........  Immunohistochemi           0.85   ..............  Agree...........         0.85
                                  stry.
88358.............  ...........  Analysis, tumor.           0.95   ..............  Agree...........         0.95
88361....  ...........  Immunohistochemi           0.94   ..............  Agree...........         0.94
                                  stry, tumor.
91110....  ...........  Gi tract capsule           3.65   ..............  Agree...........         3.65
                                  endoscopy.
95990.............  ...........  Spin/brain pump            0.00   ..............  Agree...........         0.00
                                  refil & main.
95991....  ...........  Spin/brain pump            0.77   ..............  Agree...........         0.77
                                  refil & main.
96110.............  ...........  Developmental              0.00   ..............  Agree...........         0.00
                                  test, lim.
96111.............  ...........  Developmental              2.60   ..............  Agree...........         2.60
                                  test, extend.
97537.............  ...........  Community/Work    ..............           0.45   Agree...........         0.45
                                  reintegration.
97755....  ...........  Assistive         ..............           0.62   Agree...........        0.62
                                  technology
                                  assess.
----------------------------------------------------------------------------------------------------------------
(a) No Final RUC recommendation provided.
 New CPT codes.
* All CPT codes copyright 2004 American Medical Association.
[dagger] Carrier.

    Table 6, which is titled ``AMA RUC ANESTHESIA RECOMMENDATIONS AND 
CMS DECISIONS FOR NEW AND REVISED 2004 CPT CODES'', lists the new or 
revised CPT codes for anesthesia and their base units that will be 
interim in 2004. This table includes the following information:
    [sbull] CPT code. This is the CPT code for a service.
    [sbull] Description. This is an abbreviated version of the 
narrative description of the code.
    [sbull] RUC recommendations. This column identifies the base units 
recommended by the RUC.
    [sbull] CMS decision. This column indicates whether we agreed with 
the RUC recommendation (``agree'') or we disagreed with the RUC 
recommendation (``disagree''). Codes for which we did not accept the 
RUC recommendation are discussed in greater detail following this 
table.
    [sbull] 2004 Base Units. This column establishes the 2004 base 
units for these services.

           Table 7.--AMA RUC ANESTHSIA RECOMMENDATIONS AND CMS DECISIONS FOR NEW AND REVISED CPT CODES
----------------------------------------------------------------------------------------------------------------
                                                                RUC                                   2003 base
            * CPT code                   Description      recommendation         CMS decision           units
----------------------------------------------------------------------------------------------------------------
00529....................  ANESTH, CHEST                    11   Agree....................           11
                                     PARTITION VIEW.
01173....................  ANESTH, FX REPAIR,               12   Agree....................           12
                                     PELVIS.

[[Page 63236]]


01958....................  ANESTH, ANTEPARTUM                5   Agree....................           5
                                     MANIPUL.
----------------------------------------------------------------------------------------------------------------
*All CPT codes copyright 2004 American Medical Association.
 New CPT code.

Discussion of Codes for Which There Were No RUC Recommendations or for 
Which the RUC Recommendations Were Not Accepted

    The following is a summary of our rationale for not accepting 
particular RUC work RVU or base unit recommendations. It is arranged by 
type of service in CPT order. Additionally, we also discuss those CPT 
codes for which we received no RUC recommendations for physician work 
RVUs. This summary refers only to work RVUs or base units.
    CPT code 43752 Naso- or oro-gastric tube placement, requiring 
physician's skill and fluoroscopic guidance (includes fluoroscopy, 
image documentation and report)
    The RUC recommended a work RVU of 0.82 for this service based on a 
comparison of this procedure to CPT code 44500. While we agree that CPT 
code 43752 is similar in work intensity to CPT code 44500, we feel the 
intra-service time is more appropriately valued at the 25th percentile 
(15 minutes of intra-service time vs. 20 minutes of intra-service 
time). This reduces the total time associated with CPT code 43752 from 
30 minutes to 25 minutes. We applied the ratio of the RUC recommended 
value of 0.82 work RVU over 30 minutes to the revised intra-service 
time of 25 minutes to assign 0.68 interim work RVUs for CPT code 43752.
    CPT code 63103 Vertebral corpectomy (vertebral body resection), 
partial or complete, lateral extracavitary approach with decompression 
of spinal cord and/or nerve root(s) (e.g., for tumor or retropulsed 
bone fragments); thoracic or lumbar, each additional segment. (List 
separately in addition to code for primary procedure)
    The RUC recommended a work RVU of 5.00 for this service based on a 
comparison of this procedure to CPT code 63088. It was unclear from the 
clinical vignettes supplied by the specialty society whether the 
additional corpectomy would more commonly involve the lumbar or the 
thoracic region of the spine. There is a significant difference in work 
intensity associated with the resection of an additional corpus in the 
thoracic region as opposed to the lumbar region. For this reason we 
applied the ratio of the reference service (CPT code 63088) to its 
primary service (CPT code 63087) to CPT code 63101 (primary service 
associated with CPT 63103) to assign 3.90 interim work RVUs for CPT 
code 63103.
    CPT code 61863 Twist drill, burr hole, craniotomy, or craniectomy 
with stereotactic implantation of neurostimulator electrode array in 
subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, 
periventricular, periaqueductal gray), without use of intraoperative 
microelectrode recording; first array and CPT code 61867 Twist drill, 
burr hole, craniotomy, or craniectomy with stereotactic implantation of 
neurostimulator electrode array in subcortical site (e.g., thalamus, 
globus pallidus, subthalamic nucleus, periventricular, periaqueductal 
gray), with use of intraoperative microelectrode recording; first array
    The RUC recommended a work RVU of 19.00 for CPT code 61863 and 
31.34 work RVUs for CPT code 61867. These two new CPT codes replace 
existing CPT code 61862 (work RVU=19.34). Although we agree with the 
relative relationship established by the RUC for these services, in 
order to retain budget neutrality, we adjusted the RUC recommended 
values. Thus, the recommended values were adjusted in order that the 
total relative values remain constant before and after the inclusion of 
the new CPT codes.
    We assigned 13.92 work RVUs to CPT code 61863 and 22.96 work RVUs 
to CPT code 61867.
    CPT code 38208 Transplant preparation of hematopoietic progenitor 
cells; thawing of previously frozen harvest, without washing and CPT 
code 38209 Transplant preparation of hematopoietic progenitor cells; 
thawing of previously frozen harvest, with washing
    We continue to have the same concerns as outlined in the December 
31, 2002 final rule (67 FR 80007) with respect to moving these codes 
from the laboratory fee schedule and thus establishing relative values 
under the physician fee schedule. We are maintaining a status indicator 
``I'' for these services, making them not valid for payment under the 
Medicare Physician Fee Schedule.
    CPT code 96111 Developmental testing extended (includes assessment 
of motor, language, social, adaptive, and/or cognitive functioning by 
standardized developmental instruments, eg Bayley Scales of Infant 
Development) with interpretation and report, per hour
    Although we agree with the RUC recommended work RVU of 2.60 for CPT 
code 96111, we note that the tests under this code will no longer be 
paid on a per hour basis. That is, total payment for the services under 
CPT code 96111 is based on one hour of provision of the tests. It is 
our understanding that these tests can be completed typically in one 
hour. That is, some of the tests can be administered in less than one 
hour and some may require a little more than one hour, so that the 
average time for all of the tests works out to be one hour. Therefore, 
regardless of the total number of hours it takes to complete the 
services under CPT code 96111 or whether the services are split up and 
spread over a number of days, payment will be made for 96111 based on 
only one unit/hour at 2.6 RVUs.

Establishment of Interim Practice Expense RVUs for New and Revised 
Physician's Current Procedural Terminology (CPT) Codes and New 
Healthcare Common Procedure Coding System (HCPCS) Codes for 2004.

    We have developed a process for establishing interim practice 
expense RVUs for new and revised codes that is similar to that used for 
work RVUs. Under this process, the RUC recommends the practice expense 
direct inputs, that is, the staff time, supplies and equipment, 
associated with each new code. We then review the recommendations in a 
manner similar to our evaluation of the recommended work RVUs.

[[Page 63237]]

    The RUC recommendations on the practice expense inputs for the new 
and revised 2004 codes were submitted to us as interim recommendations. 
We, therefore, consider that these recommendations are still subject to 
further refinement by the PEAC, or by us, if it is determined that such 
future review is needed. We may also revisit these inputs in light of 
future decisions of the PEAC regarding supply and equipment packages 
and standardized approaches to pre- and post-service clinical staff 
times.
    We have accepted, in the interim, almost all of the practice 
expense recommendations submitted by the RUC for the codes listed in 
the following table titled ``AMA RUC and HCPAC RVU Recommendations and 
CMS Decisions for New and Revised 2004 CPT Codes.''
    We made the following minor changes to the inputs where relevant:
    [sbull] We deleted the 3-minute phone calls in the post service 
period to conform to our established standard for all codes with 10 and 
90-day global periods.
    [sbull] We also deleted equipment when individual items did not 
meet the minimum $500 requirement.
    [sbull] We deleted certain equipment items that represent indirect, 
rather than direct costs, including lead shielding, lead lined 
radioactive waste box and lead-lined sharps box.
    [sbull] We deleted the L-Block table shield because it is included 
in the price and description of the dose calibrator, another CPEP 
equipment item.
    [sbull] We made minor changes to clinical labor and supplies, for 
several central venous access (CVA) codes in order to bring uniformity 
to this new family of codes.
    [sbull] We assigned, on an interim basis, the clinical labor RN 
designation for CPT code 95991, physician administered refilling and 
maintenance of spinal or brain implantable pump, until the PEAC has an 
opportunity to review the necessity for this clinical assignment.

V. Update to the Codes for Physician Self-Referral Prohibition

A. Background

    On January 4, 2001 we published in the Federal Register a final 
rule with comment period, ``Medicare and Medicaid Programs; Physicians 
Referrals to Health Care Entities With Which They Have Financial 
Relationships'' (66 FR 856). That final rule incorporated into 
regulations the provisions in paragraphs (a), (b) and (h) of section 
1877 of the Act. Section 1877 of the Act prohibits a physician from 
referring a Medicare beneficiary for certain ``designated health 
services'' to a health care entity with which the physician (or a 
member of the physician's immediate family) has a financial 
relationship, unless an exception applies. In the final rule, we 
published an attachment listing all of the CPT and HCPCS codes that 
defined the entire scope of the following designated health services 
for purposes of section 1877 of the Act: clinical laboratory services; 
physical therapy services (including speech-language pathology 
services); occupational therapy services; radiology and certain other 
imaging services; and radiation therapy services and supplies.
    In the January 2001 final rule, we stated that we would update the 
list of codes used to define these designated health services (the 
``Code List'') in an addendum to the annual physician fee schedule 
final rule. The purpose of the update is to conform the Code List to 
the most recent publications of CPT and HCPCS codes. The last update of 
the Code List was included in the December 31, 2002 physician fee 
schedule final rule in Addendum E and was subsequently corrected in a 
notice that was published in the Federal Register (68 FR 32400) on May 
30, 2003.
    The updated all-inclusive Code List effective January 1, 2004 is 
presented in Addendum F in this final rule. We intend to publish 
annually the all-inclusive Code List in an addendum to the physician 
fee schedule final rule. The updated all-inclusive Code List will also 
be available on our Web site at http://www.cms.hhs.gov/medlearn/refphys.asp
.

B. Response to Comments

    We received public comments on three issues relating to the most 
recent Code List. The comments and our responses are stated below.
    Comment: One commenter noted that we added three new ``Q'' codes 
(Q3021, Q3022, and Q3023) for hepatitis B vaccines. Program Memorandum 
AB-02-185 issued on December 31, 2002 deleted these HCPCS codes. 
However, the Program Memorandum also reactivated the following CPT 
codes for hepatitis B vaccine: 90740, 90743, 90744, 90746 and 90747.
    Response: The commenter is correct. We erred in adding the ``Q'' 
codes to the list of services that may qualify for an exception under 
42 CFR 411.355(h) concerning exceptions for preventive screening tests, 
immunizations, and vaccines. This was corrected in the correction 
notice published on May 30, 2003 (68 FR 32400).
    Comment: Some commenters objected to the addition of CPT code 0020T 
(Extracorporeal shock wave therapy; involving plantar fascia) to the 
list of physical therapy services for purposes of the physician self-
referral prohibition. The commenters stated that CPT 0020T is currently 
a physician service involving anesthesia and therefore, should not be 
characterized as a physical therapy service.
    Response: We agree with the commenters and have removed CPT code 
0020T from the list of designated health services. Further discussion 
of this comment and response is included in section IV.C.2 of this 
preamble concerning the HCPCS codes G0279 and G0280 relating to 
extracorporeal shock wave therapy.
    Comment: One commenter noted that the annual Code List update does 
not include codes for the following designated health services: Durable 
medical equipment and supplies; parenteral and enteral nutrients, 
equipment and supplies; prosthetics, orthotics and prothestic devices 
and supplies; home health services; outpatient prescription drugs; and 
inpatient and outpatient hospital services. The commenter recommended 
that we include the CPT and HCPCS codes for these designated health 
services in the annual update and in the quarterly updated Microsoft 
Excel spreadsheet of RVU values, global periods and supervision levels 
for Medicare covered-services posted on the CMS Web site. 
Alternatively, the commenter requested that we clarify that the Code 
List is not exhaustive and indicate where providers can obtain more 
information on the remaining categories.
    Response: As explained in the January 4, 2001 final rule with 
comment (66 FR 923), we believe that the regulatory definitions of the 
designated health services at issue are sufficiently clear to permit 
entities and physicians to identify them readily. Moreover, some of 
these designated health services are not amenable to definition solely 
through codes. Regardless, to define these services through codes or to 
change the frequency of the Code List update would require a change in 
the text of the regulatory definitions for the various designated 
health services found in Sec.  411.351. The purpose of this Code List 
is simply to make those ministerial changes necessary to conform the 
Code List to the current CPT and HCPCS code publications. Making 
substantive changes to the regulatory definitions is beyond the scope 
of this update and cannot be accomplished without first proposing

[[Page 63238]]

the changes in a Notice of Proposed Rulemaking. Lastly, we cannot 
accept the commenter's suggestion that we explain that the Code List is 
not exhaustive because such a statement is false. The Code List is 
exhaustive with respect to the specific designated health services that 
it defines, and for the reasons noted above, we are not defining the 
remaining designated health services through codes.

C. Revisions Effective for 2004

    Tables 7 and 8, below, identify the additions and deletions, 
respectively, to the comprehensive Code List last published in Addendum 
E of the December 2002 physician fee schedule final rule and 
subsequently corrected in the May 30, 2003 correction notice (68 FR 
32400). Tables 7 and 8 also identify the additions and deletions to the 
lists of codes used to identify the items and services that may qualify 
for the exceptions in Sec.  411.355(g) (regarding EPO and other 
dialysis-related outpatient prescription drugs furnished in or by an 
end-stage renal dialysis (ESRD) facility) and in Sec.  411.355(h) 
(regarding preventive screening tests, immunizations and vaccines).
    We will consider comments with respect to the codes listed in 
Tables 8 and 9 below, if we receive them by the date specified in the 
DATES section of this final rule.

 Table 8.--Additions to the Physician Self-Referral HCPCS/CPT \1\ Codes
------------------------------------------------------------------------

------------------------------------------------------------------------
                      Clinical Laboratory Services
0058T..................................  Cryopreservation, ovary tiss.
0059T..................................  Cryopreservation, oocyte.
G0027..................................  Semen analysis.
G0306..................................  CBC/diffwbc w/o platelet.
G0307..................................  CBC without platelet.
G0328..................................  Fecal blood scrn immunoassay.
----------------------------------------
  Physical Therapy, Occupational Therapy, and Speech-Language Pathology
                                Services
------------------------------------------------------------------------
97755..................................  Assistive technology assess.
----------------------------------------
              Radiology and Certain Other Imaging Services
------------------------------------------------------------------------
72198..................................  Mr angio pelvis w/o & w/dye.
76082..................................  Computer mammogram add-on.
76083..................................  Computer mammogram add-on.
76514..................................  Echo exam of eye, thickness.
91110..................................  Gi tract capsule endoscopy.
----------------------------------------
                 Radiation Therapy Services and Supplies
------------------------------------------------------------------------
G0173..................................  Stereo radiosurgery, complete.
G0251..................................  Linear acc based stero radio.
G0338..................................  Linear accelerator stero pln.
G0339..................................  Robot lin-radsurg com, first.
G0340..................................  Robt lin-radsurg fractx 2-5.
----------------------------------------
               Drugs Used by Patients Undergoing Dialysis
------------------------------------------------------------------------
Q4054..................................  Darbepoetin alfa, esrd use.
----------------------------------------
Q4055..................................  Epoetin alfa, esrd use.
----------------------------------------
         Preventive Screening Tests, Immunizations and Vaccines
------------------------------------------------------------------------
76083..................................  Computer mammogram add-on.
90655..................................  Flu vaccine, 6-35 mo, im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2003 American Medical
  Association. All rights are reserved and applicable FARS/DFARS clauses
  apply.


 Table 9.--Deletions to the Physician Self-Referral HCPCS/CPT \1\ Codes
------------------------------------------------------------------------

------------------------------------------------------------------------
  Physical Therapy, Occupational Therapy, and Speech-Language Pathology
                                Services
------------------------------------------------------------------------
0020T..................................  Extracorp shock wave tx, ft.
----------------------------------------
Q0086..................................  Physical therapy evaluation.
----------------------------------------
              Radiology and Certain Other Imaging Services
------------------------------------------------------------------------
76085..................................  Computer mammogram add-on.
76831..................................  Echo exam, uterus.
G0236..................................  Digital film conv.
GO262..................................  Sm intestinal image capsule.
----------------------------------------
                 Radiation Therapy Services and Supplies
------------------------------------------------------------------------
G0274..................................  Radiopharm tx, non-Hodgkins.
----------------------------------------
               Drugs Used by Patients Undergoing Dialysis
------------------------------------------------------------------------
Q9920..................................  Epoetin with hct < = 20.
Q9921..................................  Epoetin with hct = 21.
Q9922..................................  Epoetin with hct = 22.
Q9923..................................  Epoetin with hct = 23.
Q9924..................................  Epoetin with hct = 24.
Q9925..................................  Epoetin with hct = 25.
Q9926..................................  Epoetin with hct = 26.
Q9927..................................  Epoetin with hct = 27.
Q9928..................................  Epoetin with hct = 28.
Q9929..................................  Epoetin with hct = 29.
Q9930..................................  Epoetin with hct = 30.
Q9931..................................  Epoetin with hct = 31.
Q9932..................................  Epoetin with hct = 32.
Q9933..................................  Epoetin with hct = 33.
Q9934..................................  Epoetin with hct = 34.
Q9935..................................  Epoetin with hct = 35.
Q9936..................................  Epoetin with hct = 36.
Q9937..................................  Epoetin with hct = 37.
Q9938..................................  Epoetin with hct = 38.
Q9939..................................  Epoetin with hct = 39.
Q9940..................................  Epoetin with hct  =
                                          40.
----------------------------------------
         Preventive Screening Tests, Immunizations and Vaccines
------------------------------------------------------------------------
76085..................................  Computer mammogram add-on.
90659..................................  Flu vacine, whole, im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2003 American Medical
  Association. All rights are reserved and applicable FARS/DFARS clauses
  apply.

    The additions specified in Table 8 generally reflect new CPT and 
HCPCS codes that become effective January 1, 2004 or that became 
effective since our last update. It also reflects the addition of codes 
recently recognized by Medicare for payment purposes.
    Additionally, we are adding two G-codes (G0173, ``Stereo 
radiosurgery, complete'' and G0251, ``Linear acc based stero radio'') 
to the category of radiation therapy services and supplies. These codes 
became effective for Medicare payment purposes in August 2000 and July 
2002, respectively and should have been reflected in previous Code 
Lists.
    Table 8 also reflects the addition of 2 new HCPCS codes (Q4054 and 
Q4055) to the list of dialysis-related outpatient prescription drugs 
that may qualify for the exception described in Sec.  411.355(g) 
regarding those items. The physician self-referral prohibition will not 
apply to these drugs if they meet the conditions set forth in Sec.  
411.355(g). Table X also reflects the addition of a screening 
mammography code (CPT 76083) and a flu vaccine code (CPT 90655) to the 
list that identifies preventive screening tests, immunizations and 
vaccines that may qualify for the exception described in Sec.  
411.355(h) for such items and services. The physician self-referral 
prohibition will not apply to these services if they meet the 
conditions set forth in Sec.  411.355(h) concerning the exception for 
preventive screening tests, immunizations, and vaccines.
    Table 8 reflects the deletions necessary to conform the Code List 
to the most recent publications of CPT and HCPCS codes, as well as 
additional deletions that we have determined are necessary as described 
below.
    Under the category of physical therapy, occupational therapy and 
speech-language pathology services, we are removing CPT code 0020T, 
extracorporeal shock wave therapy for plantar fascia consistent with 
the response to the comment discussed in section IV.C.2 and VI.B of 
this preamble.
    Under the category of radiology and certain other imaging services, 
we are deleting CPT code 76831 for an echo exam of the uterus. This 
code should never have appeared on the Code List.

[[Page 63239]]

Our definition of ``radiology and certain other imaging services'' at 
Sec.  411.351 specifically excludes any x-ray, fluoroscopy or 
ultrasonic procedure that requires ``the insertion of a needle, 
catheter, tube, or probe''. The type of procedure described by CPT code 
76831 involves infusion tubing and should be removed from the Code 
List.
    Under the category of radiation therapy services and supplies, we 
are removing HCPCS code G0274 for radiopharmaceutical therapy for non-
Hodgkin's lymphoma because it is a nuclear medicine service. Our 
definition of ``radiation therapy services and supplies'' at Sec.  
411.351 specifically excludes nuclear medicine procedures. Thus, HCPCS 
code G0274 should never have appeared on the Code List.

VI. Physician Fee Schedule Update for Calendar Year 2004

A. Physician Fee Schedule Update

    The physician fee schedule update is determined using a formula 
specified by statute. Under section 1848(d)(4) of the Act, the update 
is equal to the product of 1 plus the percentage increase in the 
Medicare Economic Index (MEI) (divided by 100) and 1 plus the update 
adjustment factor (UAF). For CY 2004, the MEI is equal to 2.9 percent 
(1.029). The UAF is -7.0 percent (0.930). Section 1848(d)(4)(F) of the 
Act requires an additional -0.2 percent (0.998) reduction to the update 
for 2004. Thus, the product of the MEI (1.029), the UAF (0.930), and 
the statutory adjustment factor (0.998) equals the CY 2004 update of -
4.5 percent (0.9551).
    The negative physician fee schedule update occurs under a mandatory 
statutory formula. The law gives us no alternative to reducing the 
physician fee schedule rates. Only Congress can change the law and 
avert a reduction in 2004 physician fee schedule rates. Without a 
congressional act to change the law, the Department is compelled to 
announce a physician fee schedule update for CY 2004 of -4.5 percent. 
The Department's calculations are explained below.

B. Rebasing and Revising of the Medicare Economic Index

1. Background
    The Medicare Economic Index (MEI) is required by section 1842(b)(3) 
of the Act, which states that prevailing charge levels beginning after 
June 30, 1973 may not exceed the level from the previous year except to 
the extent that the Secretary finds, on the basis of appropriate 
economic index data, that a higher level is justified by year-to-year 
economic changes.
    Beginning July 1, 1975, and continuing through today, the MEI has 
met this requirement by reflecting the weighted sum of the annual price 
changes of the inputs used to produce physicians' services. As such, 
the MEI attempts to be an equitable measure of price changes associated 
with physician time and operating expenses.
    The current form of the MEI was detailed in the November 25, 1992 
Federal Register (57 FR 55896) and was based in part on the 
recommendations of a Congressionally-mandated meeting of experts held 
in March 1987. Since that time, the structure of the MEI has remained 
essentially unchanged, with two exceptions. First, the MEI was rebased 
in 1998 (63 FR 58845), which moved the cost structure of the index from 
1992 data to 1996 data. Second, the methodology for adjusting for 
productivity was revised in 2002 (67 FR 80019) to reflect the 
percentage change in the 10-year moving average of economy-wide 
multifactor productivity.
    We are rebasing and revising the MEI for the 2004 physician fee 
schedule update. The terms ``rebasing'' and ``revising'', while often 
used interchangeably, actually denote different activities. Rebasing 
means moving the base year for the structure of costs of an input price 
index, while revising means changing data sources, cost categories, or 
price proxies used in the input price index. As is always the case with 
a rebasing and revising exercise, we have attempted to use the most 
recently available, relevant, and appropriate information to develop 
the MEI cost category weights and price proxies. We detail below the 
updated cost weights for the MEI expense categories, our rationale for 
selecting the price proxies in the MEI, and the results of rebasing and 
revising the MEI.
2. Use of More Current Data
    The MEI was last rebased and revised in 1998 for the 1999 physician 
fee schedule update (63 FR 58845). The base year for that version of 
the MEI was 1996, which means that the cost weights in the index 
reflect physicians' expenses in 1996. However, we believe it is 
desirable to periodically rebase and revise the index so that the 
expense shares and price proxies reflect more current conditions. For 
this reason, we are rebasing the MEI to reflect physicians' expenses in 
2000. In addition, we are revising the cost categories in the MEI and 
changing three of the proxies we currently use to ensure that the index 
is appropriately reflecting price changes. We will continue to adjust 
the MEI using economy-wide multifactor productivity.
    The expense categories in the rebased and revised MEI were 
primarily derived from the 2003 AMA Physician Socioeconomic 
Characteristics publication (2003 Patient Care Physician Survey data), 
which measures physicians' earnings and overall practice expenses for 
2000. The AMA data were used to determine expenditure weights for total 
expenses, physicians' earnings, and malpractice expenses, the only 
information detailed in this survey. To further disaggregate the 
weights into subcategories reflecting more detailed expenses, we used 
data from previous AMA surveys, the 1997 Bureau of Economic Analysis 
Benchmark Input-Output table (I/O), the 2003 Bureau of Labor Statistics 
(BLS) Employment Cost Index (ECI), and the 2002 Bureau of the Census 
Current Population Survey (CPS).
3. Rebasing and Revising Expense Categories in the MEI

a. Developing the Weights for Use in the MEI

    Developing a rebased and revised MEI requires selecting a base year 
and determining the number and composition of expense categories and 
their associated price proxies. We are rebasing the MEI to CY 2000. CY 
2000 was chosen as the base year for two main reasons: (1) CY 2000 was 
the most recent year for which data were available from the AMA, and 
(2) we believed that the CY 2000 data were representative of the 
changing distribution of physicians' earnings and practice expenses 
over time.
    Comment: One commenter suggested that we update the weights in the 
MEI to a more recent base year, possibly CY 2004. While the commenter 
agreed with us that there is a lack of data to do so, the commenter 
suggested using the price change in each of the proxies to estimate 
weights for 2004 as an alternative to 2000 data.
    Response: We selected CY 2000 as the base year for two reasons: (1) 
CY 2000 data were the most recent data available from the AMA, and (2) 
we felt the CY 2000 data were representative of the changing 
distribution of physician earnings and practice expenses over time. We 
do not expect that the experience of the past 3 or 4 years would have a 
significant impact on the MEI for the CY 2004 update, particularly 
since changing the weights from 1996 to 2000 had such a minimal effect. 
In addition, the price proxies that we use capture the current price 
changes in each of the categories that make up the MEI.

[[Page 63240]]

    While we agree that it would be optimal to develop MEI weights 
based on more recent data, we recognize the lack of data to do so. We 
also recognize that an alternative would be to use price changes in 
each of the proxies to update the weights to a more recent base year, 
similar to the methodology we used to develop the distribution of 
detailed practice expense categories in the current structure. In that 
case, we used price changes from 1998 to 2000 to develop weights for 
2000.
    However, as we indicated in the proposed rule, this method has a 
major drawback in that it assumes that the quantity of inputs would 
increase at the same rate as the price of those inputs. This may not be 
the case over longer time periods (for instance, 2000-2004) where there 
is likely to be substitution away from more costly inputs toward those 
which are less costly. Our experience with rebasing indexes has also 
shown that the weights for major categories do not change very much 
over time, even though the individual price changes for those 
categories can differ significantly. In addition, because the MEI is a 
Laspeyres-type index, the price changes between the base period and the 
current period are reflected in the relative importance of each 
category in determining the overall increase. Therefore, we feel that 
basing the index on CY 2000 data and reflecting current price changes 
likely represents a reasonable estimate of physicians' current 
experience.
    We determined the number and composition of expense categories 
based on the criteria used to develop the current MEI and other CMS 
input price index expenditure weights. These criteria are timeliness, 
reliability, relevance, and public availability. For more information 
on these criteria, see the May 9, 2002 Federal Register (67 FR 31444) 
and the detail later in this preamble. Table 10 lists the set of 
mutually exclusive and exhaustive cost categories that make up the 
rebased and revised MEI.

    Table 10.--Rebased and Revised Medicare Economic Index Expenditure Categories, Weights, and Price Proxies
----------------------------------------------------------------------------------------------------------------
                                                 2000--Expense
                Expense category                   weights\1\   1996--Expense             Price proxy
                                                      \2\          weights
----------------------------------------------------------------------------------------------------------------
    Total......................................       100.000        100.000   .................................
------------------------------------------------
Physician Earnings \3\.........................        52.466         54.460   .................................
    Wages and Salaries.........................        42.730         44.197   AHE--Private.
    Benefits \4\...............................         9.735         10.263   ECI--Ben: Private.
Physician Practice Expenses....................        47.534         45.540   .................................
    Nonphysician Employee Compensation.........        18.653         16.812   .................................
    Employee Wages and Salaries................        13.808         12.424   .................................
        Prof/Tech Wages........................         5.887          5.662   ECI--W/S: Private P&T.
        Managerial Wages.......................         3.333          2.410   ECI--W/S: Private Admin.
        Clerical Wages.........................         3.892          3.830   ECI--W/S: Private Clerical.
        Services Wages.........................         0.696          0.522   ECI--W/S: Private Service.
    Employee Benefits \4\......................         4.845          4.388   ECI--Ben: Priv. White Collar.
    Other Practice Expenses....................        18.129   .............  .................................
    Office Expenses............................        12.209         11.581   CPI(U)--Housing.
    Professional Liability Insurance...........         3.865          3.152   CMS--Prof. Liab. Phys. Premiums.
    Medical Equipment..........................         2.055          1.878   PPI--Medical Instruments & Equip.
    Pharmaceuticals and Medical Materials and           4.319          4.516   .................................
     Supplies.
    Medical Materials and Supplies.............         2.011   .............  PPI Surg. Appliances and Supplies/
                                                                                CPI (U) Med Supplies.
    Pharmaceuticals............................         2.308   .............  PPI Pharmaceutical Preparations.
    Other Expenses.............................         6.433          7.601   CPI-U All Items Less Food and
                                                                                Energy.
----------------------------------------------------------------------------------------------------------------
\1\ Due to rounding, weights may not sum to 100.000 percent.
\2\ Sources: Physician Socioeconomic Statistics, 2000-2002 Edition (SMS Survey), Physician Socioeconomic
  Statistics, 2003 Edition (PCPS Survey), Center for Health Policy Research, American Medical Association; 2003
  Employment Cost Index, U.S. Department of Labor, Bureau of Labor Statistics; U.S. Department of Commerce,
  Bureau of Economic Analysis 1997 Benchmark Input Output Tables, and U.S. Department of Commerce, Bureau of the
  Census, 2002 Current Population Survey.
\3\ Includes employee physician payroll.
\4\ Includes paid leave.

    To determine the expenditure weights for the rebased and revised 
MEI, we used currently available and statistically valid data sources 
on physician earnings and practice expenses. While we consulted 
numerous data sources, we used five data sources to determine the MEI 
expenditure weights: (1) The 2003 AMA Physician Socioeconomic 
Statistics (2000 survey data) for self-employed physicians, (2) the 
2000-2002 AMA Physician Socioeconomic Statistics (1998 data) for self-
employed physicians, (3) the March 2003 BLS Employment Cost Index, (4) 
the 2002 Bureau of the Census Current Population Survey, and (5) the 
Bureau of Economic Analysis (BEA) 1997 Benchmark Input-Output tables 
(I/O). No one data source provided all of the information needed to 
determine expenditure weights according to our criteria. The 
development of each of the cost categories using these sources is 
described in detail below.

b. Physician Earnings

    The rebased and revised MEI uses AMA data on mean physician net 
income (physician earnings) for self-employed physicians to develop a 
weight for physician earnings. The weight for this expense category is 
based on AMA data for 2000 and is calculated as a percentage of total 
mean expenses (physician earnings and practice expenses, including 
malpractice). The physician earnings expenditure category also includes 
employee physician compensation.

[[Page 63241]]

Currently, physician earnings and overhead expenses generated by 
employee physicians are included in the AMA practice expenses category. 
However, we believe it is appropriate, for our purposes, to place 
employee physician compensation in the MEI cost category of physician 
earnings. Including employee physician payroll in physician earnings in 
the MEI is consistent with the current payment methodologies in 
accordance with the physician fee schedule, where the work RVU is 
computed based on what service is provided and not on who provides the 
service. Since employee physicians perform the same services as self-
employed physicians, employee physician time is reflected in the work 
RVU. By including the compensation of employee physicians in the 
physician earnings expense category, these expenses will be adjusted by 
the appropriate price proxies for time spent by a physician.
    To obtain further detail for both wages/salaries and benefits, the 
ratio between these categories for 1996 (based on the 1996-based MEI) 
was updated to 2000 using the growth in the overall Employment Cost 
Index for private employees for wages/salaries and benefits. 
Alternative data for determining this split were not readily available 
from any other source. The main shortcoming of this method is that any 
changes in quantity and intensity (mix of physicians) are not 
reflected. However, faced with the lack of alternative data, we deemed 
this approach to be the most feasible, and the results appear to be 
consistent with anecdotal evidence on this ratio. Its application 
resulted in a wage-fringe benefit split of 81.4 and 18.6 percent, 
respectively, in the revised and rebased MEI compared with a wage-
fringe benefit split of 81.2 and 18.8 percent, respectively, in the 
1996-based MEI.

c. Physician Practice Expenses

    To determine the remaining individual practice expense weights 
other than malpractice expense, we updated AMA expense data from 1998 
to 2000 using the relative price change in an appropriate price index. 
After the levels were updated to 2000 values, it was necessary to 
normalize these levels to equal the 2000 mean total expense data 
provided by the 2003 AMA survey. The detailed explanations for the 
derivation of the individual weights are listed below.
(i) Nonphysician Employee Compensation
    The cost share for nonphysician employee compensation was developed 
by updating the 1998 AMA Socioeconomic Survey data on nonphysician 
employee compensation costs for self-employed physicians to 2000, using 
the current proxy for this category, and dividing the resulting amount 
into total expenses (physician earnings plus practice expenses) for 
2000 from the AMA survey. We further divided this cost share into 
wages/salaries and benefits using BLS Employment Cost Index data. The 
ECI survey contains data on the proportion of total compensation 
accounted for by wages/salaries and benefits (including paid leave) by 
private industry health services occupational category. These 
proportions can be used to distribute the total nonphysician employee 
compensation weight to wages/salaries and benefits for non-physician 
employees. We used 2000 data from the March 2003 publication. Although 
this survey does not contain data specifically for offices of 
physicians, data are available on wage/fringe shares for private 
industry health services, which include hospitals, nursing homes, 
offices of physicians, and offices of dentists. We believe the data for 
health services from the survey do provide a reasonable estimate of the 
split between wages and fringe benefits for employees in physicians' 
offices. Data for 2000 in the ECI survey for total health services 
indicate that wages and fringe benefits are 74.02 percent and 25.98 
percent of compensation, respectively. As in the 1996-based MEI, we 
will use CPS data on earnings by occupation to develop cost shares for 
wages for nonphysician occupational groups shown in Table 6. To arrive 
at a distribution for these separate categories, we multiplied the 
overall share for nonphysician employee wages/salaries by each of the 
occupational proportions from the 2000 CPS. This distribution for the 
1996-based and 2000-based MEI are presented in Table 10.

   Table 11.--Percent Distribution of Nonphysician Payroll Expense by
                    Occupational Group: 2000 and 1996
------------------------------------------------------------------------
                                               2000            1996
         BLS occupational group             expenditure     expenditure
                                              shares          shares
------------------------------------------------------------------------
    Total...............................         100.000         100.000
                                         ================
------------------------------------------------------------------------
\1\ Due to rounding, weights may not sum to 100.000 percent.

(ii) Professional Liability Expense
    The weight for professional liability expense was derived from the 
2003 AMA survey (2000 data) and was calculated as the mean professional 
liability expense expressed as a percentage of total expenses 
(physician earnings plus practice expenses). This calculation resulted 
in a 3.865 percent share of total costs in 2000 compared to a 3.152 
percent share in the 1996-based index. The increase in weight for 
professional liability insurance represents the increases in both 
premiums and the amount of coverage purchased by physicians in 2000 
compared to 1996. While the weight does not reflect the cost experience 
for 2001 and 2002, the proxy used in the rebased and revised index does 
reflect the price increases associated with the recent rise in 
malpractice costs.
    Comment: Some commenters were concerned that the rebased and 
revised MEI does not appropriately reflect the recent increase in 
professional liability insurance (PLI) premiums that physicians are 
experiencing.
    Response: As we indicated in the proposed rule, the weights in the 
rebased and revised MEI reflect the distribution of physicians' costs 
in CY 2000 and do not reflect the more recent experience of physicians, 
particularly as it pertains to PLI. While it would be optimal to base 
the weights on more recent data, there is not a more recent, 
comprehensive measure that would meet our criteria for determining 
weights in the MEI.
    We also indicated that while the weights do not reflect the more 
recent

[[Page 63242]]

experience, the proxy we use to measure the price change in this 
category does reflect more recent price changes in premiums and is the 
most current data available through the second quarter of 2003. This 
MEI PLI data, like that used in the development of the GPCIs, does not 
reflect total expenditures on PLI, which would be needed to develop 
more current weights for the MEI. In order to develop cost weights, 
expenditure data for all costs facing physicians are needed.
(iii) Office, Medical Equipment, Pharmaceuticals and Medical Materials 
and Supplies Expenses, and Other Expenses
    The 2003 AMA survey provides less detail for expenses with respect 
to prior years' publications. Therefore, we calculated the share of 
each of the above categories by updating the AMA data for 1998 to 2000 
using an appropriate price proxy. The primary reason for using the 
price proxy was that we lacked other data to develop cost weights for 
each of these categories. As stated previously, the main deficiency of 
this method is that it does not directly account for changes in the 
quantity or intensity associated with these expenses. Our belief, 
however, was that it was important to continue using these detailed 
breakouts so that each would be proxied by an appropriate price index 
and that the quantity/intensity effects over a short period of time are 
not likely to be large. In fact, we have found that even over longer 
periods of time, the distribution of costs tends to be relatively 
similar.
    Office expenses and medical equipment levels were moved to 2000 
using the growth from 1998 to 2000 in their respective MEI price 
proxies. In the case of office expenses, we used the growth in the CPI-
U Housing; for medical equipment expenses, we used the growth in the 
PPI for Medical Instruments and Equipment.
    The share for pharmaceuticals (prescription drugs) and medical 
materials and supplies was calculated by separating out pharmaceuticals 
and other medical materials and supplies using 1997 BEA Benchmark 
Input-Output data. First, the sum of all the pharmaceuticals and 
medical supplies categories from the Benchmark Input-Output tables for 
1997 was calculated. The share of pharmaceuticals and medical supplies 
was then calculated as a percentage of this total and applied to the 
1997 AMA medical supplies data. These calculated levels were then aged 
to 2000 using the growth in an appropriate price proxy. We thought it 
was important and appropriate to account for each of these categories 
separately so that differences in relative price growth between 
pharmaceuticals (prescription drugs) and other medical materials and 
supplies would be more accurately represented. The resulting 2000 data 
for the two separate categories were then aggregated (summed) together 
to form the overall total for the share for the pharmaceuticals and 
medical materials and supplies category in the rebased and revised MEI. 
The pharmaceuticals category was aged using the Producer Price Index 
(PPI) for Pharmaceutical preparations and the medical materials and 
supplies category was updated using the PPI for surgical appliances and 
supplies.
    Finally, the Other Expenses category was calculated as a residual 
(total expenses less the percentage of all categories currently 
accounted for). The additional detail for transportation expenses found 
in the 1996-based MEI was removed because the data were not readily 
available for measurement of a cost share for 2000. The effect on the 
MEI of removing the detail is negligible.
    Comment: One commenter suggested for the purposes of future changes 
to the MEI, that CMS consider inputs that are vastly different than 
when the MEI was first developed, such as costs of complying with 
government regulatory requirements and interpreter services for 
patients.
    Response: We thoroughly research many of the known data sources on 
a regular basis to determine the appropriate number of detailed 
categories that make up the MEI. If we determine that a different 
combination of inputs is needed we will revise the MEI to reflect a 
more current cost distribution. However, CMS does not have the detailed 
expenditure and price data for the types of expenditures the commenter 
indicated. CMS will continue to work with other outside entities in the 
future to ensure the MEI is as accurate and representative as possible. 
It should also be noted that these costs are already captured in the 
MEI, as all costs are captured in the index, just not separately broken 
out for the reasons previously stated.
4. Selection of Price Proxies for Use in the MEI
    After the 2000 cost weights for the rebased and revised MEI were 
developed, we reviewed the current set of price proxies to determine 
whether they were still the most appropriate for each expenditure 
category. As was the case in the development of the 1996-based MEI (57 
FR 55901), most of the indicators we considered are based on BLS data 
and are grouped into one of the following five categories:

Producer Price Indices (PPIs)

    Producer price indices (PPIs) measure price changes for goods sold 
in other than retail markets. They are the preferred proxies for 
physician purchases at the wholesale level. These fixed-weight indices 
are a measure of price change at the producer or at the intermediate 
stage of production, a more likely mode of purchase for physicians.

Consumer Price Indices (CPIs)

    Consumer price indices (CPIs) measure change in the prices of final 
goods and services purchased by consumers. Like the PPIs, they are 
fixed-weight. Since they may not represent the price changes faced by 
producers, CPIs were used if there were no appropriate PPI or if the 
expenditure category was similar to expenditure of retail consumers in 
general.

Average Hourly Earnings (AHEs)

    Average hourly earnings (AHEs) are available for production and 
nonsupervisory workers for specific industries as well as for the 
nonfarm business economy. They are calculated by dividing gross 
payrolls for wages/salaries by total hours. The series reflects shifts 
in employment mix and, thus, is representative of actual changes in 
hourly earnings for industries or for the nonfarm business economy.

ECIs for Wages/Salaries

    These ECIs measure the rate of change in employee wage rates per 
hour worked. These fixed-weight indices are not affected by shifts in 
industry or occupation employment levels and measure only the pure rate 
of change in wages.

ECIs for Employee Benefits

    These ECIs measure the rate of change in employer costs of employee 
benefits, such as the employer's share of Social Security taxes, 
pension and other retirement plans, insurance benefits (life, health, 
disability, and accident), and paid leave. Like ECIs for wages/
salaries, the ECIs for employee benefits are not affected by changes in 
industry output or occupational shifts.
    When choosing wage and price proxies for each expense category, we 
evaluate the strengths and weaknesses of each proxy variable using four 
criteria. The first criterion is relevance. The price variable should 
appropriately represent price changes for specific goods or services 
within the expense category. Relevance may encompass judgments about 
relative efficiency of

[[Page 63243]]

the market generating the price and wage increases.
    The second criterion is reliability or low sampling variability. If 
the proxy wage-price variable has a high sampling variability or 
inexplicable erratic patterns over time, its value is greatly 
diminished, since it is unlikely to accurately reflect price changes in 
its associated expenditure category. Low sampling variability can 
conflict with relevance, since the more specifically a price variable 
is defined in terms of service, commodity, or geographic area, the 
higher the possibility of sampling variability.
    The third criterion is timeliness of actual published data. For 
this reason, we prefer monthly and quarterly data to annual data. The 
length of time the time series data have been published is also 
important. A well-established time series is needed to assess the 
reasonableness of the series and to provide a solid base from which to 
forecast future price changes in the series. We need to forecast the 
MEI to make Federal budget and Trustees Report estimates.
    The fourth criterion is public availability. We prefer to use data 
sources that are publicly available for our indices so that the public 
may track each of the individual components in the MEI.
    The BLS price proxy categories previously described meet the 
criteria of relevance, reliability, timeliness, and public 
availability. Below we discuss the price-wage proxies for the rebased 
and revised MEI (shown in Table 5).

(a) Expense Categories in the MEI

Physician Time

    In the rebased and revised MEI, we are using the AHE for the 
private nonfarm economy as the proxy for the physician wages/salaries 
component; this is the same price measure used in the 1996-based MEI. 
In our judgment, this proxy still most closely comports with 
Congressional intent as expressed in the Senate Finance Committee's 
1972 report (S. Rept. No. 92-1230 at 191 (1972)). It should be noted 
that AHEs change in accordance with changes in the type and mix of 
workers.
    As we discussed extensively in the November 2, 1998 final rule (63 
FR 58848) and again in the December 31, 2002 final rule (67 FR 80019), 
we believe that the current price proxy for physicians' earnings--AHE 
in the nonfarm business economy--is the most appropriate proxy to use 
in the MEI. The AHE for the nonfarm business economy reflects the 
impacts of supply, demand, and economy-wide productivity for the 
average worker in the economy. Using this measure as the proxy for 
physicians' earnings ensures parity in the rate of change in wages for 
the average worker and those for physicians. In addition, use of this 
proxy is consistent with the original legislative intent that the 
change in the physicians' earnings portion of the MEI parallel the 
change in general earnings for the economy. Since earnings are 
expressed per hour, a constant quantity of labor input per unit of time 
is reflected. The use of the AHE data is also consistent with our using 
the BLS economy-wide multifactor productivity measures since economy-
wide wage increases reflect economy-wide productivity increases.
    Using the ECI for professional and technical workers or other 
occupational-specific wage proxies has a major shortcoming; in many 
instances, occupations such as engineering, computer science, and 
nursing have unique characteristics that are not representative of the 
overall economy or the physician market. Specifically, wage changes for 
such occupations can be influenced by excess supply or demand for these 
types of workers. We believe it would not be appropriate to proxy the 
physician earnings portion of the MEI with a wage proxy that reflects 
these other occupation's unique characteristics. The 2000-based MEI 
will use the ECI for fringe benefits for total private industry as the 
price proxy for physician fringe benefits, the same proxy used for the 
1996-based MEI. This means that both the wage and fringe benefit 
proxies for physician earnings are derived from the nonfarm private 
sector and are computed on a per-hour basis.

Nonphysician Employee Compensation

    As in the 1996-based MEI, we used Current Population Survey data on 
earnings and employment by occupation to develop labor cost shares for 
the nonphysician occupational groups shown in Table 10. BLS maintains 
an ECI for each occupational group, and we use these ECIs as price 
proxies for nonphysician employee wages in the 2000-based MEI.
    The skill mix shift in employees of physician offices in the last 
few years has been towards managerial occupations. While these skill 
mix shifts are captured in the expenditure weights, they are 
appropriately held constant in a Laspeyres price index such as the MEI. 
Skill mix shifts, which may reflect the changing intensity of services 
provided in physicians' offices, are accounted for in the payment 
system outside of the MEI. The 2000-based MEI will use the ECI for 
fringe benefits for white collar employees in the private sector as a 
proxy for nonphysician benefits since most nonphysician employees in 
physicians' offices are white-collar employees. This is the same proxy 
used for the 1996-based MEI.

Office Expense

    Office expenses include rent or mortgage for office space, 
furnishings, insurance, utilities, and telephone. We continue to use 
the CPI-U for housing because it is a comprehensive measure of the cost 
of housing, including rent, owner's equivalent rent, and the types of 
goods and services associated with running an office. This proxy covers 
about 80 percent of the population.

Pharmaceuticals and Medical Materials and Supplies

    This cost category includes drugs, outside laboratory work, x-ray 
films, and other related services. There is not one price proxy that 
includes this complete mix of materials and supplies. In the absence of 
one index, we separately accounted for pharmaceuticals and medical 
materials and supplies in the 2000-based MEI.
    [sbull] Medical Materials and Supplies
    We equally weighted two proxies together (the PPI Surgical 
Appliances and Supplies and the CPI-U for Medical Equipment and 
Supplies) since one proxy does not accurately measure the price change 
associated with these types of products used nor the mode of purchase 
used in physicians' offices. While both indexes include such items as 
bandages, dressings, catheters, I.V. equipment, syringes, and other 
general disposable medical supplies and nonprescription equipment, the 
indexes reflect significant differences in the mode of purchase. The 
PPI measures actual transaction prices at the wholesale level, the mode 
most likely used by physicians, while the CPI measures prices at the 
retail level or the final stage of production. The price movements in 
these two indexes can be different and we believe that it is 
appropriate to combine these indexes into one proxy since physicians 
likely use both purchasing methods when obtaining medical supplies.
    [sbull] Pharmaceuticals
    The PPI for pharmaceutical preparations is used to proxy 
pharmaceutical prices in other CMS market baskets and reflects the 
price change associated with the average mix of pharmaceuticals 
purchased economy-wide. We use the PPI for pharmaceutical preparations, 
rather than the CPI for prescription drugs, because physicians 
generally purchase drugs directly from a

[[Page 63244]]

wholesaler. The PPIs we use measure price changes at the final stage of 
production and not intermediate production, however.

Professional Liability Insurance

    It is vital that the MEI accurately reflect the price changes 
associated with professional liability costs. Accordingly, we continue 
to incorporate into the MEI a price proxy that accomplishes this goal 
by making the maximum use of available data on professional liability 
premiums.
    Each year, we solicit professional liability premium data for 
physicians from a small sample of commercial carriers. This information 
is not collected through a survey form but instead is requested, on a 
voluntary basis, from a few national commercial carriers via letter. 
Generally between 5 and 8 carriers volunteer this information. For the 
CY 2004 update we were able to obtain data from 7 carriers, all of 
which were in the top 15 companies in 2001 in terms of market share. 
While the sample size certainly does not cover the entire professional 
liability insurance market, we have attempted to maximize the market 
share in terms of both national coverage and coverage within States.
    As we require for our other price proxies, the professional 
liability price proxy should reflect the pure price change associated 
with this particular cost category. Thus, it should not capture changes 
in the mix or level of liability coverage. To accomplish this result, 
we obtain premium information from commercial carriers for a fixed 
level of coverage, currently $1 million per occurrence and a $3 million 
annual limit. This information is collected for every State by 
physician specialty and risk class. Finally, the State-level, 
physician-specialty data are aggregated by effective premium date to 
compute a national total, using counts of physicians by State and 
specialty as provided in the AMA publication, Physician Characteristics 
and Distribution in the U.S.
    The resulting data provide a quarterly time series, indexed to a 
base year consistent with the MEI and reflect the national trend in the 
average professional liability premium for a given level of coverage. 
From this series, quarterly and annual percent changes in professional 
liability insurance are estimated for inclusion in the MEI.
    Our research has indicated that the most comprehensive data on 
professional liability costs are held by the State insurance 
commissioners but these data are available only with a substantial time 
lag and, therefore, the data currently incorporated into the MEI are 
much more timely. We believe that, given the limited data available on 
professional liability premiums, this methodology adequately reflects 
the price trends facing physicians.
    Comment: Several commenters were concerned about the 6.6 percent 
increase in the PLI component of the MEI published in the proposed rule 
and felt that this did not represent the actual increase in premiums 
physicians are experiencing.
    Response: We indicated in the proposed rule that the 6.6 percent 
increase in the PLI component of the index was based on a forecast. For 
this final rule we have incorporated actual data (through the second 
quarter of 2003) that indicates that the increase in the proxy for the 
PLI component of the MEI is 16.9 percent.

Medical Equipment

    Medical equipment includes depreciation, leases, and rent on 
medical equipment. We will use the PPI for medical instruments and 
equipment as the price proxy for this category, consistent with the 
price proxy used in the 1996-based MEI and other CMS input price 
indexes.

Other Expenses

    This category includes the residual subcategory of other expenses 
such as accounting services, legal services, office management 
services, continuing education, professional association memberships, 
journals, professional car expenses, and other professional expenses. 
In the absence of one price proxy or even a group of price proxies that 
might reflect this heterogeneous mix of goods and services, we use the 
CPI-U for all items less food and energy, consistent with the price 
proxy used in the 1996-based MEI. We also condensed the structure 
compared to that used in the 1996-based MEI because we lack the data to 
develop a representative weight for transportation, as discussed above. 
This change resulted in only a negligible effect on the overall MEI 
over the past 8 years; the average annual increase differs by less than 
a tenth of a percentage point over that time.

(b) Productivity Adjustment to the MEI

    In the December 2002 final rule, we indicated that we were changing 
the methodology for adjusting for productivity in the MEI. The MEI used 
for the 2003 physician payment update reflected changes in the 10-year 
moving average of private nonfarm business (economy-wide) multifactor 
productivity applied to the entire index; we had previously used 
economy-wide private nonfarm business labor productivity applied to the 
labor portions of the index. We will continue to use the new method, 
adjusting for multifactor productivity applied to the entire index, in 
the rebased and revised MEI.
    As described in the December 31, 2002 (68 FR 9568) final rule, we 
use multifactor productivity because: (1) It is theoretically more 
appropriate to explicitly reflect the productivity gains associated 
with all inputs (both labor and nonlabor); (2) the recent growth rate 
in economy-wide multifactor productivity appears to be more consistent 
with the current market conditions facing physicians; and (3) the MEI 
still uses economy-wide wage changes as a proxy for physician wage 
changes. We also believe that using a 10-year moving average change in 
economy-wide multifactor productivity produces a stable and predictable 
adjustment and is consistent with the moving-average methodology used 
in the 1996-based MEI. The adjustment will be based on the latest 
available actual historical economy-wide multifactor productivity data, 
as measured by BLS. For the 2004 update, this means using the 
multifactor productivity data through 2001, the latest available 
information.
5. Results of Rebasing
    Because the rebased and revised MEI is similar in structure to the 
1996-based MEI, updating the MEI from a 1996 base year to a 2000 base 
year resulted in small changes in expense category weights. Physicians' 
earnings dropped slightly, from 54.5 percent of the index in 1996 to 
52.5 percent in 2000. The expense shares for non-physician employee 
compensation, office expenses, professional liability insurance, and 
medical equipment all rose slightly, while expense shares for medical 
materials and supplies and other expenses declined.
    The update using the rebased and revised MEI for the 2004 Physician 
Fee Schedule is an increase of 2.9 percent. This incorporates 
historical data through the second quarter of 2003.


[[Continued on page 63245]]


From the Federal Register Online via GPO Access [wais.access.gpo.gov]
]                         
 
[[pp. 63245-63294]] Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule for Calendar Year 2004

[[Continued from page 63244]]

[[Page 63245]]



  Table 12.--Annual Percent Change in the Revised and Rebased Medicare
                  Economic Index, 2004--All Categories
------------------------------------------------------------------------
  Increase in the Medicare Economic Index Update for Calendar Year 2004
                                   \1\
-------------------------------------------------------------------------
                                           2000 weights    2004 percent
   Cost categories and price measures           \2\           changes
------------------------------------------------------------------------
Medicare Economic Index Total,                       n/a             2.9
 productivity adjusted..................
    Productivity: 10-year moving average             n/a             0.9
     of Multifactor productivity,
     private nonfarm business sector....
Medicare Economic Index Total, without           100.000             3.8
 productivity adjustment................
    1. Physician's Own Time \3\.........          52.466             3.6
        a. Wages and Salaries: Average            42.730             3.2
         Hourly Earnings, private
         Nonfarm........................
        b. Fringe Benefits: Employment             9.735             5.4
         Cost Index, benefits, private
         nonfarm........................
    2. Physician's Practice Expense \3\.          47.534             4.0
        a. Nonphysician Employee                  18.653             3.4
         Compensation...................
            1. Wages and Salaries:                13.808             2.8
             Employment Cost Index,
             wages and salaries,
             weighted by occupation.....
            2. Fringe Benefits:                    4.845             5.0
             Employment Cost Index,
             fringe benefits, white
             collar.....................
        b. Office Expense: Consumer               12.209             2.5
         Price Index (CPI-U), housing...
        c. Drugs and Medical Materials             4.319             3.1
         and Supplies...................
            1. Medical Materials and               2.011             1.0
             Supplies: Producer Price
             Index, surgical appliances
             and supplies/Consumer Price
             Index (CPI-U), medical
             equipment and supplies
             (equally weighted).........
            2. Pharmaceuticals: Producer           2.308             4.9
             Price Index (PPI
             pharmaceutical
             preparations)..............
        d. Professional Liability                  3.865            16.9
         Insurance: premiums \4\........
        e. Medical Equipment: PPI,                 2.055             2.3
         medical instruments and
         equipment......................
        f. Other Expenses...............           6.433            1.9
------------------------------------------------------------------------
\1\ The rates of historical change are estimated for the 12-month period
  ending June 30, 2002, which is the period used for computing the
  calendar year 2004 update. The price proxy values are based upon the
  latest available Bureau of Labor Statistics data as of September 22,
  2002.
\2\ The weights shown for the MEI components are the 2000 base-year
  weights, which may not sum to subtotals or totals because of rounding.
  The MEI is a fixed-weight, Laspeyres-type input price index whose
  category weights indicate the distribution of expenditures among the
  inputs to physicians' services for calendar year 2000. To determine
  the MEI level for a given year, the price proxy level for each
  component is multiplied by its 2000 weight. The sum of these products
  (weights multiplied by the price index levels) over all cost
  categories yields the composite MEI level for a given year. The annual
  percent change in the MEI levels is an estimate of price change over
  time for a fixed market basket of inputs to physicians' services. Due
  to rounding, weights may not sum to 100.000 percent.
\3\ The measures of productivity, average hourly earnings, Employment
  Cost Indexes, as well as the various Producer and Consumer Price
  Indexes can be found on the Bureau of Labor Statistics Web site http://stats.bls.gov
.
\4\ Derived from data collected from several major insurers (the latest
  available historical percent change data are for the period ending
  second quarter of 2003).
n/a Productivity is factored into the MEI categories as an adjustment to
  the price variables; therefore, no explicit weight exists for
  productivity in the MEI.

    As is the case with this index rebasing, our experience in previous 
rebasing and revising indexes has been that there is usually a very 
small effect on the overall percent change. The difference is typically 
between zero and 0.3 percentage points per year on average. The rebased 
and revised MEI overall percent increase for the CY 2004 update is only 
0.1 percentage point higher compared to the 1996-based MEI. This is 
also the case for this final rule. When the MEI was last rebased, there 
was no difference in the average annual percentage change from 1985 to 
1998. When the PPS hospital indices were rebased, the average 
difference in the percentage change was less than one-tenth of a 
percentage point from 1995 to 2002.
    The first reason for this small difference between the 1996-based 
and 2000-based MEI percent changes is that the weight of professional 
liability insurance increased, giving it a higher relative importance 
in the index in 2000. This category also increased at a faster pace 
than other index categories during 2002 and projected for 2003, 
resulting in an even greater relative importance for this index by 2004 
and causing it to have a larger effect on the overall index compared to 
the 1996-based MEI.
    In addition, the pharmaceuticals from the medical materials and 
supplies category grew faster than the overall medical materials and 
supplies in the 1996-based MEI. In addition, the faster growth in the 
aggregate medical materials and supplies category combined with a 
higher weight in the 2000-based index gave the category a higher 
relative importance. However, these increases were mostly offset by 
declines in weight of some of the other categories, most notably 
physician earnings.
6. Adjustments to RVUs To Match the New MEI Weights
    As discussed in the August 15, 2003 proposed rule, section 
1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases 
in RVUs may not cause the amount of expenditures for the year to differ 
by more than $20 million from what expenditures would have been in the 
absence of these changes. If this threshold is exceeded, we make 
across-the-board adjustments to preserve budget neutrality. Therefore, 
if we adjust the work, practice expense and malpractice RVUs to match 
the new MEI weights, we are required by statute to ensure that the 
adjustments do not increase or decrease Medicare expenditures by more 
than $20 million. To meet the requirements of the statute and ensure 
that aggregate pools of RVUs match the proposed new MEI weights, we 
considered two options. We considered either making no adjustments to 
the physician work RVUs and adjusting only the practice expense and 
malpractice RVUs or adjusting all 3 categories of RVUs. We proposed 
adjusting all 3 categories of RVUs rather than adjusting only the 
practice expense and malpractice RVUs, which would have resulted in a 
reduction to the physician fee schedule conversion factor in addition 
to the -4.2 percent reduction that was forecasted. Specifically, we 
proposed to reduce the physician work RVUs by an estimated 0.35 percent 
(0.9965) and the practice expense RVUs by an estimated 1.15 percent 
(0.9885) and to increase the malpractice RVUs by an estimated 21.7 
percent (1.217) to match the rebased MEI weights.

[[Page 63246]]

    Comment: We received comments from a number of physician 
organizations opposing any adjustment to the physician work RVUs. 
Several of the comments appreciated our reluctance to reduce the 
physician fee schedule conversion factor by an additional 0.3 
percentage points when there will already be a large reduction in the 
physician fee schedule update. One commenter stated that any additional 
reduction to the physician fee schedule conversion factor would be 
inappropriate. However, these comments also stated that that the 
physician work RVUs should remain constant and stable. There were a 
number of comments that stated that across-the-board adjustments should 
never be applied to the work component of the Resource Based Relative 
Value System. One comment indicated that we should not make any 
adjustments to the work RVUs unless they are recommended by the RUC. 
Several of the comments stated that the proposed adjustments to the 
RVUs to match the MEI weights would not assist the physician community 
in addressing the professional liability crisis since any increase in 
physician fees for some services will be offset by reductions in other 
services. Additional payments by Medicare to cover increased 
professional liability costs, or congressional action, are necessary to 
alleviate this problem. Some of the comments indicated that CMS did not 
provide sufficient information to make a determination as to how the 
two proposals would affect individual codes because the adjustments 
were not applied to the RVUs shown in Addendum B of the proposed rule. 
Several of the comments stated that the stability of work RVUs is 
essential since they are used by private payors, physician compensation 
systems, and in productivity analysis. The RUC commented that they 
depend upon the stability in these values as they review new and 
revised codes, both in magnitude estimation and in any calculations 
regarding intra-work per unit of time (IWPUT). One comment suggested 
CMS create a separate adjustment factor to adjust payments without 
changing the conversion factor or the RVUs, as it did for the first 
five-year review of the Medicare physician fee schedule in 1995. We 
also received a comment urging us to review the Secretary's ``ancillary 
policies'' authority under section 1848(c)(4) of Act to determine 
whether CMS has statutory authority to increase PLI relative value 
units without reducing the work and practice expense relative value 
units.
    We also received several comments that expressed support for 
maintaining stability in the practice expense RVUs. The comment stated 
``much like what is done with work relative values, any code-level 
refinements due to annual coding changes that result in a non-budget 
neutral impact should not result in a reduction of all practice expense 
relative values. The comment requested that CMS present an analysis of 
this issue in an upcoming proposed rule and recommended that 
adjustments related to the MEI rebasing not be applied to the practice 
expense relative values.
    Response: We share the concern about establishing stability in the 
practice expense RVUs. As we indicated in the June 28, 2002 proposed 
rule (67 FR 43851), ``once the refinement process is complete, we 
believe the physician community has a reasonable expectation that the 
practice expense RVUs will not change from year to year unless further 
refinement is undertaken.'' We plan to analyze in an upcoming proposed 
rule whether there are any alternatives to our current practice of 
rescaling the practice expense RVUs to apply budget neutrality. 
However, we disagree with the comments that suggest we only increase 
the malpractice expense RVUs and not apply any adjustments to the work 
and practice expense RVUs to match the MEI weights. It is not possible 
to match the aggregate RVUs to the new MEI weights if we make no 
adjustments to both work and practice expense and adjust only the 
malpractice RVUs and the conversion factor. While it would be possible 
to maintain budget neutrality for the increase in malpractice RVUs by 
reducing the conversion factor, the aggregate number of RVUs for work 
and practice expense would not match the MEI weights unless we could 
adjust at least two of the three RVUs in combination with applying a 
compensating adjustment to the CF.
    We have considered the comment suggesting that we use the 
Secretary's section 1848(c) ``ancillary'' policies authority to adjust 
the RVUs to match the MEI weights but not maintain budget neutrality. 
Section 1848(c) states that the Secretary may establish ancillary 
policies (with respect to the use of modifiers, local codes, and other 
matters) as may be necessary to implement this section.'' We believe 
that this section of the statute must, nonetheless, be read 
consistently with the requirements of section 1848(c)(2)(B)(ii)(II) of 
the Act requiring that changes to RVUs cannot cause the amount of 
expenditures to increase or decrease by more than $20 million from the 
amount of expenditures that would have been made if such adjustments 
had not been made. We believe the statute is clear and any increase in 
the malpractice expense RVUs must be offset by decreases to the work 
and practice expense RVUs or the conversion factor.
    We also do not believe that the work RVUs should be maintained and 
a separate ``work adjustor'' established. While such policy was adopted 
following the 5-year review of physician work in 1997, we used this 
procedure only because the effect of the work adjustor could be removed 
once resource-based practice expense RVUs were adopted in 1999. We did 
not find the work adjustor to be desirable. It added an extra element 
to the physician fee schedule payment calculation and created confusion 
and questions among the public who had difficulty using the RVUs 
determine a payment amount that matched the amount actually paid by 
Medicare.
    We acknowledge the comments that indicate that the work RVUs are 
used for many purposes other than Medicare payment. While our proposal 
would slightly reduce the absolute value of the physician work RVUs, it 
would not change their relative values since there would be a uniform 
decrease to all of the RVUs. We believe the relative relationship among 
the values for the services makes them useful for analysis for purposes 
other than Medicare payment. Since the relative values will be left 
unchanged, we do not believe the work RVUs will lose their utility for 
these other uses.
    We disagree that our proposed rule did not provide enough 
information upon which to determine the impact on payment for a given 
service. The proposed rule provided the specific level of the estimated 
adjustments. While we did not actually apply the adjustments to the 
RVUs shown in Addendum B, any interested party could determine the 
effect of our proposal on any given service with the information we 
provided. We further noted that the adjustments we provided were 
estimated and would change once we made final determinations of the 
work, practice expense and malpractice RVUs for 2004. For the final 
rule, we will reduce the work RVUs by 0.57 percent (0.9943), the 
practice expense by 0.77 (0.9923) percent and increase the malpractice 
RVUs by 19.86 percent (1.1986). We have also modeled the impact of our 
proposal by specialty in the impact section of this final rule.
    With respect to the comments about our proposal and the large 
increases in professional liability premiums, we

[[Page 63247]]

have not asserted that our policy to adjust the RVUs will resolve this 
issue. While the comments that our policy will increase payments for 
some service and decrease payments for payments for others are correct, 
we note that payments for services with high malpractice RVUs will 
increase the most in payment while there will be negligible impact on 
payment for most other services. Such a policy will improve our payment 
policies by giving more weight to the malpractice RVU in determining 
Medicare total payment consistent with the proportion that professional 
liability expenses represent of total physician expenses. As indicated 
in the impact section, services provided by cardiac and thoracic 
surgeons, neurosurgeons, orthopedic surgeons, vascular surgeons and 
emergency physicians are increasing in payment as a result of this 
proposal. There will be little impact of these adjustments on all other 
specialties.

C. The Update Adjustment Factor

    Section 1848(d) of the Act provides that the physician fee schedule 
update is equal to the product of the MEI and an ``update adjustment 
factor'' or UAF. The UAF is applied to make actual and target 
expenditures (referred to in the law as ``allowed expenditures'') 
equal. Allowed expenditures are equal to actual expenditures in a base 
period updated each year by the SGR. The SGR sets the annual rate of 
growth in allowed expenditures and is determined by a formula specified 
in section 1848(f) of the Act.
1. Calculation Under Current Law
    Under section 1848(d)(4)(A) of the Act, the physician fee schedule 
update for a year is equal to the product of--(1) 1 plus the 
Secretary's estimate of the percentage increase in the MEI for the 
year, divided by 100 and (2) 1 plus the Secretary's estimate of the UAF 
for the year. Under section 1848(d)(4)(B) of the Act, the UAF for a 
year beginning with 2001 is equal to the sum of the following--
    [sbull] Prior Year Adjustment Component. An amount determined by--
    [sbull] Computing the difference (which may be positive or 
negative) between the amount of the allowed expenditures for 
physicians' services for the prior year (the year prior to the year for 
which the update is being determined) and the amount of the actual 
expenditures for such services for that year;
    [sbull] Dividing that difference by the amount of the actual 
expenditures for such services for that year; and
    [sbull] Multiplying that quotient by 0.75.
    [sbull] Cumulative Adjustment Component. An amount determined by--
    [sbull] Computing the difference (which may be positive or 
negative) between the amount of the allowed expenditures for 
physicians' services from April 1, 1996, through the end of the prior 
year and the amount of the actual expenditures for such services during 
that period;
    [sbull] Dividing that difference by actual expenditures for such 
services for the prior year as increased by the sustainable growth rate 
for the year for which the update adjustment factor is to be 
determined; and
    [sbull] Multiplying that quotient by 0.33.
    Section 1848(d)(4)(E) of the Act requires the Secretary to 
recalculate allowed expenditures consistent with section 1848(f)(3) of 
the Act. Section 1848(f)(3) specifies that the SGR (and, in turn, 
allowed expenditures) for the upcoming calendar year (2004 in this 
case), the current calendar year (2003) and the preceding calendar year 
(2002) are to be determined on the basis of the best data available as 
of September 1 of the current year. Allowed expenditures are initially 
estimated and subsequently revised twice. The second revision occurs 
after the calendar year has ended (that is, we are making the final 
revision to 2002 allowed expenditures in this final rule). Once the SGR 
and allowed expenditures for a year have been revised twice, they are 
final.
    Table 13 shows annual and cumulative allowed expenditures for 
physicians' services from April 1, 1996 through the end of the current 
calendar year, including the transition period to a calendar year 
system that occurred in 1999.

                                                    Table 13
----------------------------------------------------------------------------------------------------------------
                                                         Cumulative
                                       Annual allowed      allowed
                Period                  expenditures    expenditures                   FY/CY  SGR
                                            ($ in           ($ in
                                          billions)       billions)
----------------------------------------------------------------------------------------------------------------
4/1/96-3/31/97.......................            48.9            48.9  N/A
4/1/97-3/31/98.......................            50.5            99.4  FY 1998 = 3.2%
4/1/98-3/31/99.......................            52.6           152.0  FY 1999 = 4.2%
1/1/99-3/31/99.......................            13.3           (\1\)  FY 1999 = 4.2%
4/1/99-12/31/99......................            42.1           (\2\)  FY 2000 = 6.9%
1/1/99-12/31/99......................            55.3           194.1  FY 1999/2000\3\
1/1/00-12/31/00......................            59.4           253.4  CY 2000 = 7.3%
1/1/01-12/31/01......................            62.0           315.5  CY 2001 = 4.5%
1/1/02-12/31/02......................            67.2           382.6  CY 2002 = 8.2%
1/1/03-12/31/03......................            71.7           454.2  CY 2003 = 6.7%
1/1/04-12/31/04......................            77.0           528.6  CY 2004 = 7.4%
----------------------------------------------------------------------------------------------------------------
\1\ Allowed expenditures for the first quarter of 1999 are based on the FY 1999 SGR.
\2\ Allowed expenditures for the last three quarters of 1999 are based on the FY 2000 SGR.
\3\ Allowed expenditures in the first year (April 1, 1996-March 31, 1997) are equal to actual expenditures. All
  subsequent figures are equal to quarterly allowed expenditure figures increased by the applicable SGR.
  Cumulative allowed expenditures are equal to the sum of annual allowed expenditures. We provide more detailed
  quarterly allowed and actual expenditure data on our Web site under the Medicare Actuary's publications at the
  following address: http://www.cms.hhs.gov/statistics/actuary/. We expect to update the web site with the most
  current information later this month.

    Consistent with section 1848(d)(4)(E) of the Act, table 13 includes 
our final revision of allowed expenditures for 2002, a recalculation of 
allowed expenditures for 2003, and our initial estimate of allowed 
expenditures for 2004. To determine the update adjustment factor for 
2004, the statute requires that we use allowed and actual expenditures 
from April 1, 1996 through December 31, 2003 and the 2004 SGR. 
Consistent with section 1848(d)(4)(E), we will be making further 
revisions to 2003 and 2004 SGRs and 2003 allowed expenditures. Because 
we have

[[Page 63248]]

incomplete actual expenditure data for 2003, we are using an estimate 
for this period. Any difference between current estimates and final 
figures will be taken into account in determining the update adjustment 
factor for future years.
    We are using figures from table 13 in the statutory formula 
illustrated below:
[GRAPHIC] [TIFF OMITTED] TR07NO03.000

UAF = Update Adjustment Factor
Target03 = Allowed Expenditures for 2003 or $71.7 billion
Actual03 = Estimated Actual Expenditures for 2003 = $77.8 
billion
Target4/96-12/03 = Allowed Expenditures from 4/1/1996-12/31/
2002 = $454.2 billion
Actual4/96-12/02 = Estimated Actual Expenditures from 4/1/
1996-12/31/2003 = $462.0 billion
SGR03 = 7.4 percent (1.074)
[GRAPHIC] [TIFF OMITTED] TR07NO03.001

    Section 1848(d)(4)(D) of the Act indicates that the UAF determined 
under section 1848(d)(4)(B) of the Act for a year may not be less than 
-0.070 or greater than 0.03. The calculated UAF of -0.090 is less than 
the statutory limit of -0.070. Therefore, the UAF for 2004 will be -
0.70.
    Section 1848(d)(4)(A)(ii) of the Act indicates that 1 should be 
added to the UAF determined under section 1848(d)(4)(B) of the Act. 
Thus, adding 1 to -0.070 makes the update adjustment factor equal to 
0.930.

VII. Allowed Expenditures for Physicians' Services and the Sustainable 
Growth Rate

A. Medicare Sustainable Growth Rate

    The SGR is an annual growth rate that applies to physicians' 
services paid for by Medicare. The use of the SGR is intended to 
control growth in aggregate Medicare expenditures for physicians' 
services. Payments for services are not withheld if the percentage 
increase in actual expenditures exceeds the SGR. Rather, the physician 
fee schedule update, as specified in section 1848(d)(4) of the Act, is 
adjusted based on a comparison of allowed expenditures (determined 
using the SGR) and actual expenditures. If actual expenditures exceed 
allowed expenditures, the update is reduced. If actual expenditures are 
less than allowed expenditures, the update is increased.
    Section 1848(f)(2) of the Act specifies that the SGR for a year 
(beginning with 2001) is equal to the product of the following four 
factors:
    (1) The estimated change in fees for physicians' services.
    (2) The estimated change in the average number of Medicare fee-for-
service beneficiaries.
    (3) The estimated projected growth in real GDP per capita.
    (4) The estimated change in expenditures due to changes in law or 
regulations.
    In general, section 1848(f)(3) of the Act requires us to publish 
SGRs for 3 different time periods, no later than November 1 of each 
year, using the best data available as of September 1 of each year. 
Under section 1848(f)(3)(C)(i) of the Act, the SGR is estimated and 
subsequently revised twice (beginning with the FY and CY 2000 SGRs) 
based on later data. (The Consolidated Appropriations Reduction 
Resolution of 2003 (P.L. 108-7) contained a provision permitting 
revision of the FY 1998 and FY 1999 SGRs. See the February 28, 2003 
Federal Register (68 FR 9567) for a discussion of these SGRs. Under 
section 1848(f)(3)(C)(ii) of the Act, there are no further revisions to 
the SGR once it has been estimated and subsequently revised in each of 
the 2 years following the preliminary estimate. In this final rule, we 
are making our preliminary estimate of the 2004 SGR, a revision to the 
2003 SGR, and our final revision to the 2002 SGR.

B. Physicians' Services

    Section 1848(f)(4)(A) of the Act defines the scope of physicians' 
services covered by the SGR. The statute indicates that the term 
``physicians' services'' includes other items and services (such as 
clinical diagnostic laboratory tests and radiology services), specified 
by the Secretary, that are commonly performed or furnished by a 
physician or in a physician's office, but does not include services 
furnished to a Medicare+Choice plan enrollee. We published a definition 
of physicians' services for use in the SGR in the Federal Register (66 
FR 55316) on November 1, 2001. We defined ``physicians' services'' to 
include many of the medical and other health services listed in section 
1861(s) of the Act. For purposes of determining allowed expenditures, 
actual expenditures, and SGRs through December 31, 2002, we have 
specified that ``physicians' services'' include the following medical 
and other health services if bills for the items and services are 
processed and paid by Medicare carriers (and those items and services 
paid through intermediaries where specified):
    [sbull] Physicians' services.
    [sbull] Services and supplies furnished incident to physicians' 
services.
    [sbull] Outpatient physical therapy services and outpatient 
occupational therapy services.
    [sbull] Antigens prepared by or under the direct supervision of a 
physician.
    [sbull] Services of physician assistants, certified registered 
nurse anesthetists, certified nurse midwives, clinical psychologists, 
clinical social workers, nurse practitioners, and clinical nurse 
specialists.
    [sbull] Screening tests for prostate cancer, colorectal cancer, and 
glaucoma.
    [sbull] Screening mammography, screening pap smears, and screening 
pelvic exams.
    [sbull] Diabetes outpatient self-management training services.
    [sbull] Medical nutrition therapy services.
    [sbull] Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests (including outpatient diagnostic laboratory 
tests paid through intermediaries).
    [sbull] X-ray, radium, and radioactive isotope therapy.
    [sbull] Surgical dressings, splints, casts, and other devices used 
for the reduction of fractures and dislocations.
    [sbull] Bone mass measurements.

[[Page 63249]]

C. Provisions Related to the Sustainable Growth Rate

    Section 211(b)(1) of the BBRA amended section 1848(f)(1) of the Act 
to require that three SGR estimates be published in the Federal 
Register not later than November 1 of every year. In this final rule, 
we are publishing our preliminary estimate of the SGR for 2004, a 
revised estimate of the SGR for 2003, and our final determination of 
the SGR for 2002. Consistent with section 1848(f)(3)(C) of the Act, we 
are using the best data available to us as of September 1, 2003 for all 
of the figures.

D. Preliminary Estimate of the SGR for 2004

    Our preliminary estimate of the 2004 SGR is 7.4 percent. We first 
estimated the 2004 SGR in March and made the estimate available to the 
Medicare Payment Advisory Commission and on our website. Table 13 shows 
our March estimates and our current estimates of the factors included 
in the SGR:

                                Table 14
------------------------------------------------------------------------
                                                             Current
           Statutory factors             March estimate      estimate
------------------------------------------------------------------------
Fees..................................     2.3% (1.023)     2.7% (1.027)
Enrollment............................     1.3% (1.013)     1.7% (1.017)
Real Per Capita GDP...................     2.7% (1.027)     2.8% (1.028)
Law and Regulation....................     0.0% (1.000)     0.0% (1.000)
                                       ------------------
    Total.............................     6.4% (1.064)     7.4% (1.074)
------------------------------------------------------------------------


    Note: Consistent with section 1848(f)(2) of the Act, the 
statutory factors are multiplied, not added, to produce the total 
(that is, 1.027 x 1.017 x 1.028 x 1.000 = 1.074.) A more detailed 
explanation of each figure is provided below in section G.1.

E. Revised SGR for 2003

    Our current estimate of the 2003 SGR is 6.7 percent. Table 14 shows 
our preliminary estimate of the 2003 SGR that was published in the 
Federal Register on December 1, 2002 (67 FR 80027) and our current 
estimate:

                                Table 15
------------------------------------------------------------------------
                                            12/31/02         Current
           Statutory factors                estimate         estimate
------------------------------------------------------------------------
Fees..................................     2.9% (1.029)     2.8% (1.028)
Enrollment............................     1.2% (1.012)     2.4% (1.024)
Real Per Capita GDP...................     3.3% (1.033)     1.4% (1.014)
Law and Regulation....................     0.0% (1.000)     0.0% (1.000)
                                       ------------------
    Total.............................     7.6% (1.076)     6.7% (1.067)
------------------------------------------------------------------------

    A more detailed explanation of each figure is provided below in 
section G.2.

F. Final Sustainable Growth Rate for 2002

    The SGR for 2002 is 8.3 percent. Table 16 shows our preliminary 
estimate of the SGR published in the Federal Register on November 1, 
2001 (66 FR 55317), our revised estimate published in the Federal 
Register on December 31, 2001 (67 FR 80028) and the final figures 
determined using the latest available data:

                                                    Table 16
----------------------------------------------------------------------------------------------------------------
                                                                      11/1/01        12/31/02
                        Statutory factors                            estimate     estimate (\1\)       Final
----------------------------------------------------------------------------------------------------------------
Fees............................................................    2.3% (1.023)    2.5% (1.025)    2.5% (1.025)
Enrollment......................................................    0.7% (1.007)    2.8% (1.028)    3.2% (1.032)
Real Per Capita GDP.............................................    1.7% (1.027)    2.3% (1.023)    1.4% (1.014)
Law and Reg.....................................................    0.8% (1.008)    1.1% (1.011)    1.0% (1.010)
                                                                 -----------------
----------------------------------------------------------------------------------------------------------------
\1\ The figures for fees, enrollment and real per capita GDP from the 12/31/02 final rule are shown here. We
  made a subsequent change to the law and regulations factor and the total in the February 28, 2003 Federal
  Register (68 FR 9572). We show the revised law and regulation factor and total in the above table.


[[Page 63250]]

    A more detailed explanation of each figure is provided below in 
section G.2.

G. Calculation of 2004, 2003, and 2002 Sustainable Growth Rates

1. Detail on the 2004 SGR
    All of the figures used to determine the 2004 SGR are estimates 
that will be revised based on subsequent data. Any differences between 
these estimates and the actual measurement of these figures will be 
included in future revisions of the SGR and allowed expenditures and 
incorporated into subsequent physician fee schedule updates.

Factor 1--Changes in Fees for Physicians' Services (Before Applying 
Legislative Adjustments) for CY 2004

    This factor is calculated as a weighted average of the 2004 fee 
increases for the different types of services included in the 
definition of physicians' services for the SGR. Medical and other 
health services paid using the physician fee schedule are estimated to 
account for approximately 80.3 percent of total allowed charges 
included in the SGR in 2004 and are updated using the MEI. The MEI for 
2004 is 2.9 percent. Diagnostic laboratory tests are estimated to 
represent approximately 7.4 percent of Medicare allowed charges 
included in the SGR in 2004 and the costs of these tests are updated by 
the CPI-U. The CPI-U for 2004 that will be used to update clinical 
diagnostic laboratory tests is 2.1 percent. Drugs represent 12.3 
percent of Medicare allowed charges included in the SGR. We are 
projecting a weighted average change in fees for drugs that are 
included in the SGR of 2.0 percent. Table 16 shows the weighted average 
of the MEI, laboratory and drug price increases for 2004:

                                Table 17
------------------------------------------------------------------------
                                                   Weight       Update
------------------------------------------------------------------------
Physician.....................................        0.803          2.9
Laboratory....................................        0.074          2.1
Drugs.........................................        0.123          2.0
Weighted Average..............................        1.000          2.7
------------------------------------------------------------------------

    After taking into account the elements described in table 16, we 
estimate that the weighted-average increase in fees for physicians' 
services in 2004 under the SGR (before applying any legislative 
adjustments) will be 2.7 percent.

Factor 2--The Percentage Change in the Average Number of Part B 
Enrollees from 2003 to 2004

    This factor is our estimate of the percent change in the average 
number of fee-for-service enrollees from 2003 to 2004. Services 
provided to Medicare+Choice (M+C) plan enrollees are outside the scope 
of the SGR and are excluded from this estimate. Our actuaries estimate 
that the average number of Medicare Part B fee-for-service enrollees 
will increase by 1.7 percent from 2003 to 2004. Table 18 illustrates 
how this figure was determined:

                                Table 18
------------------------------------------------------------------------
                                                    2003         2004
------------------------------------------------------------------------
Overall.......................................   \1\ 38.535   \1\ 39.013
Medicare +Choice..............................    \1\ 4.689    \1\ 4.606
Net...........................................   \1\ 33.847   \1\ 34.407
Percent Increase..............................  ...........     \2\ 1.7
------------------------------------------------------------------------
\1\ Millions.
\2\ Percent.

    An important factor affecting fee-for-service enrollment is 
beneficiary enrollment in Medicare+Choice plans. Because it is 
difficult to estimate the size of the Medicare+Choice enrollee 
population before the start of a calendar year, at this time, we do not 
know how actual enrollment in Medicare+Choice plans will compare to 
current estimates. For this reason, the estimate may change 
substantially as actual Medicare fee-for-service enrollment for 2004 
becomes known.

Factor 3--Estimated Real Gross Domestic Product Per Capita Growth in 
2004

    We estimate that the growth in real per capita GDP from 2003 to 
2004 will be 2.8 percent. Our past experience indicates that there have 
also been large changes in estimates of real per capita GDP growth made 
before the year begins and the actual change in GDP computed after the 
year is complete. Thus, it is likely that this figure will change as 
actual information on economic performance becomes available to us in 
2004.

Factor 4--Percentage Change in Expenditures for Physicians' Services 
Resulting From Changes in Law or Regulations in CY 2004 Compared With 
CY 2003

    We are not projecting any change in spending in 2004 due to changes 
in law or regulations.
2. Detail on the 2003 SGR
    A more detailed discussion of our revised estimates of the four 
elements of the 2003 SGR follows.

Factor 1--Changes in Fees for Physicians' Services (Before Applying 
Legislative Adjustments) for 2003

    This factor was calculated as a weighted average of the 2003 fee 
increases that apply for the different types of services included in 
the definition of physicians' services for the SGR.
    We estimate that services paid using the physician fee schedule 
account for approximately 82.7 percent of total allowed charges 
included in the SGR in 2003. These services were updated using the 2003 
MEI of 3.0 percent. We estimate that diagnostic laboratory tests 
represent approximately 7.1 percent of total allowed charges included 
in the SGR in 2003. These services were updated by the 2003 CPI-U of 
1.1 percent. We estimate that drugs represent 10.2 percent of Medicare 
allowed charges included in the SGR in 2003. Pursuant to section 
1842(o) of the Act, Medicare pays for drugs based on 95 percent of AWP. 
Using wholesale pricing information and Medicare utilization for drugs 
included in the SGR, we estimate weighted average fee increases for 
drugs of 1.9 percent in 2003. Table 19 shows the weighted average of 
the MEI, laboratory and drug price increases for 2003:

                                Table 19
------------------------------------------------------------------------
                                                   Weight       Update
------------------------------------------------------------------------
Physician.....................................        0.827          3.0
Laboratory....................................        0.071          1.1
Drugs.........................................        0.102          1.9
Weighted Average..............................        1.000          2.8
------------------------------------------------------------------------

    After taking into account the elements described in table 19, we 
estimate that the weighted-average increase in fees for physicians' 
services in 2003 under the SGR (before applying any legislative 
adjustments) will be 2.8 percent.

Factor 2--The Percentage Change in the Average Number of Part B 
Enrollees from 2002 to 2003

    Our actuaries estimate that the average number of Medicare Part B 
fee-for-service enrollees (excluding beneficiaries enrolled in M+C 
plans) increased by 2.4 percent in 2003. Table 20 illustrates how we 
determined this figure:

                                Table 20
                              [In millions]
------------------------------------------------------------------------
                                                    2002         2003
------------------------------------------------------------------------
Overall.......................................       38.074       38.535

[[Page 63251]]


Medicare +Choice..............................        5.005        4.689
Net...........................................       33.069       33.847
Percent Increase..............................  ...........         2.4%
------------------------------------------------------------------------

    Our actuaries' estimate of the 2.8 percent change in the average 
number of fee-for-service enrollees, net of Medicare+Choice enrollment 
for 2003, compared to 2002 is different from our preliminary estimate 
(1.2 percent for 2003 from the December 31, 2002 final rule (67 FR 
80029)) because the historical base from which our actuarial estimate 
is made has changed. We now have complete information on Medicare fee-
for-service enrollment for 2002 that is different than the figure we 
used one year ago. Further, we now have information on actual fee-for-
service enrollment for the first 8 months of 2003. We would caution 
that our estimate of fee-for-service enrollment for 2003 could change 
again once we have complete information for the entire year.

Factor 3--Estimated Real Gross Domestic Product Per Capita Growth in 
2003

    We estimate that the growth in real per capita GDP will be 1.4 
percent in 2003. Our past experience indicates that there have also 
been large differences between our estimates of real per capita GDP 
growth made prior to the year's end and the actual change in this 
factor. Thus, it is likely that this figure will change further as 
complete actual information on 2003 economic performance becomes 
available to us in 2004.

Factor 4--Percentage Change in Expenditures for Physicians' Services 
Resulting From Changes in Law or Regulations in 2003 Compared With 2002

    There were no statutory or regulatory changes that affected 
Medicare expenditures for services included in the SGR in 2003.
3. Detail on the 2002 SGR
    A more detailed discussion of our revised estimates of the four 
elements of the 2002 SGR follows.

Factor 1--Changes in Fees for Physicians' Services (Before Applying 
Legislative Adjustments) for 2002

    This factor was calculated as a weighted average of the 2002 fee 
increases that apply for the different types of services included in 
the definition of physicians' services for the SGR.
    Services paid using the physician fee schedule accounted for 
approximately 84.1 percent of total Medicare allowed charges included 
in the SGR in 2002, and are updated using the MEI. The MEI for 2002 was 
2.6 percent. Diagnostic laboratory tests represent approximately 7.2 of 
total Medicare allowed charges included in the SGR, and are typically 
updated by the CPI-U. However, the BBA required a 0.0 percent update in 
2002 for laboratory services. Drugs represented approximately 8.7 
percent of total Medicare allowed charges included in the SGR in 2002. 
Pursuant to section 1842(o) of the Act, Medicare pays for drugs based 
on 95 percent of AWP. Using wholesale pricing information and Medicare 
utilization for drugs included in the SGR, we estimate a weighted 
average fee increase for drugs of 2.8 percent in 2002. Table 21 shows 
the weighted average of the MEI, laboratory and drug price increases 
for 2002:

                                Table 21
------------------------------------------------------------------------
                                                   Weight       Update
------------------------------------------------------------------------
Physician.....................................        0.841          2.6
Laboratory....................................        0.072          0.0
Drugs.........................................        0.087          2.8
Weighted Average..............................        1.000          2.5
------------------------------------------------------------------------

    After taking into account the elements described in table 21, we 
estimate that the weighted-average increase in fees for physicians' 
services in 2002 under the SGR (before applying any legislative 
adjustments) was 2.5 percent.

Factor 2--The Percentage Change in the Average Number of Part B 
Enrollees from 2001 to 2002

    We estimate the increase in the average number of fee-for-service 
enrollees (excluding beneficiaries enrolled in M+C plans) from 2001 to 
2002 was 3.2 percent. Our calculation of this factor is based on 
complete data from 2002. Table 22 illustrates the calculation of this 
factor:

                                Table 22
                              [In millions]
------------------------------------------------------------------------
                                                    2001         2002
------------------------------------------------------------------------
Overall.......................................       37.650       38.074
Medicare +Choice..............................        5.608        5.005
Net...........................................       32.041       33.069
Percent Increase..............................  ...........         3.2%
------------------------------------------------------------------------

Factor 3--Estimated Real Gross Domestic Product Per Capita Growth in 
2002

    We estimate that the growth in real per capita GDP was 1.4 percent 
in 2002. This is a final figure based on complete data for 2002.

Factor 4--Percentage Change in Expenditures for Physicians' Services 
Resulting From Changes in Law or Regulations in 2002 Compared With 2001

    Sections 101 through 104 of the BIPA added Medicare coverage for a 
variety of new services that will affect the 2002 SGR. In addition, 
section 112 of BIPA made changes that will result in additional 
Medicare coverage for certain drugs that will affect 2002 spending for 
services included in the SGR. Prior to the enactment of the BIPA, 
Medicare paid only for drugs that cannot be self-administered by the 
patient. BIPA allows Medicare to pay for drugs that can be, but are not 
usually, self-administered. Accordingly, we are accounting for the 
increased Medicare drug expenditures that will result from 
implementation of section 112 of the BIPA. We are also adjusting this 
factor to account for including screening mammography services in the 
SGR consistent with our discussion of this issue in the November 1, 
2001 Federal Register (66 FR 55318). After taking these provisions into 
account, our final estimate of the percentage change in expenditures 
for physicians' services resulting from changes in law or regulations 
is 1.0 percent for 2002.

VIII. Anesthesia and Physician Fee Schedule Conversion Factors for 
Calendar Year 2004

    The 2004 physician fee schedule CF will be $35.1339. The 2004 
national average anesthesia conversion factor is $16.43.
    The specific calculations to determine the physician fee schedule 
and anesthesia CFs for 2004 are explained below.

Detail on Calculation of the 2004 Physician Fee Schedule Conversion 
Factor

Physician Fee Schedule Conversion Factor
    Under section 1848(d)(1)(A) of the Act, the physician fee schedule 
CF is equal to the CF for the previous year multiplied by the update 
determined under section 1848(d)(4) of the Act.
    We are illustrating the calculation for the 2004 physician fee 
schedule CF in table 23:

[[Page 63252]]



                                Table 23
------------------------------------------------------------------------

------------------------------------------------------------------------
2003 Conversion Factor.......................................   $36.7856
2004 Update..................................................     0.9551
2004 Conversion Factor.......................................   $35.1339
------------------------------------------------------------------------

Anesthesia Fee Schedule Conversion Factor
    Anesthesia services do not have RVUs like other physician fee 
schedule services. Therefore, we account for any necessary RVU 
adjustments through an adjustment to the anesthesia fee schedule CF. We 
are adjusting the anesthesia CF to reflect the RVUs adjustments being 
made to all other physician fee schedule services to match the revised 
MEI weights. The 2003 anesthesia CF is $17.05. Physician work 
represents 79.02 percent of the anesthesia CF (0.7902). We are 
decreasing this portion of the anesthesia CF by 0.57 percent (0.9943). 
Practice expenses represent 13.75 percent (0.1375) of the anesthesia 
CF. We are reducing this portion of the anesthesia conversion factor by 
0.77 percent (0.9923) for the adjustment to match the RVUs with the MEI 
weights. In addition, we are increasing the practice expense portion of 
the anesthesia CF by 0.18 percent (1.0018) for changes to anesthesia 
practice expenses resulting from the refinement of practice expense 
RVUs. Taken together, we are reducing the practice expense portion of 
the anesthesia fee schedule CF by 0.59 percent (0.9923 x 1.0018 = 
0.9941). Professional liability insurance represents 7.23 percent 
(0.0723) of the anesthesia CF. We are increasing this portion of the 
anesthesia CF by 19.86 percent (1.1986). Taken together, the 
adjustments to the work, practice expense and malpractice portions of 
the anesthesia CF result in a total adjustment of 1.090 percent (0.7903 
*0.9943) + ((0.1347 x 0.9941) + (0.0723 x 1.1986) = 1.0090. To 
determine the anesthesia fee schedule CF for 2004, we used the 
following figures:

                                Table 24
------------------------------------------------------------------------

------------------------------------------------------------------------
2003 Anesthesia Conversion Factor............................   $17.0522
Adjustments to match MEI weights and practice expense factor.     1.0090
2004 Update..................................................     0.9551
2004 Anesthesia Conversion Factor............................   $16.4339
------------------------------------------------------------------------

IX. Telehealth Originating Site Facility Fee Payment Amount Update

    Section 1834(m) of the Act establishes the payment amount for the 
Medicare telehealth originating site facility fee for telehealth 
services provided from October 1, 2001, through December 31 2002, at 
$20. For telehealth services provided on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the MEI as defined in 
section 1842(i)(3) of the Act. The MEI increase for 2004 is 2.9 
percent.
    Therefore, for CY 2004, the payment amount for HCPCS code ``Q3014, 
telehealth originating site facility fee'' is 80 percent of the lesser 
of the actual charge or $21.20.
    The Medicare telehealth originating site facility fee and MEI 
increase by the applicable time period is shown below.

                                Table 25
------------------------------------------------------------------------
                                                     MEI
                  Facility fee                     increase     Period
                                                  (percent)
------------------------------------------------------------------------
$20.00..........................................       N/A   10/01/2001-
                                                              12/31/2002
$20.60..........................................       3.0   01/01/2003-
                                                              12/31/2003
$21.20..........................................       2.9   01/01/2004-
                                                              12/31/2004
------------------------------------------------------------------------

X. Provisions of the Final Regulations

    This final rule with comment period adopts the provisions of the 
August 2003 proposed rule except as noted elsewhere in the preamble. 
The following is a highlight of the changes made from the proposed 
rule.
    For geographic practice cost indices, based upon the volatility of 
the premium data collected, our review of the comments received on the 
August 15, 2003 proposed rule, and our review of malpractice GPCIs, we 
have modified some of our GPCI calculations and assumptions. We reduced 
the overall impact associated with revision to the malpractice GPCIs by 
a factor of 50 percent to mitigate for the volatility of the data. As 
directed by the statute, we will implement half of this change in the 
first year (CY 2004) and half of this change in the second year (CY 
2005).
    For the creation G codes for monitoring heart rhythms issue, based 
on concerns raised by commenters, we will not proceed with the proposed 
HCPCS codes because we want to ensure that any HCPCS codes developed, 
encompass the various technologies that are being utilized for such 
monitoring.
    For changes in payments to physicians managing patients on 
dialysis, we are moving forward with our proposals and we are adjusting 
the payment rates for the established G codes. In addition we are 
adding additional codes to address the concerns raised about home 
dialysis.
    For the definition of diabetes for diabetes self-management 
training we adopted the AACE clinical definition. We also expanded our 
general language to include other types of diabetes.
    For excision of benign and malignant lesions, we are not moving 
forward with our proposal, however, we will maintain the 2003 work RVUs 
as interim values for 2004 to allow opportunity for the specialty to 
resurvey these services.
    For payment policies for anesthesia services we have decided to 
allow teaching anesthesiologists to bill, similarly to teaching CRNAs, 
for their involvement in two concurrent cases involving residents.

XI. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

XII. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, if we proceed with a subsequent document, we will respond to the 
major comments in the preamble to that document.

XIII. Regulatory Impact Analysis

    We have examined the impact of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980 Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects, 
distributive impacts, and equity). A regulatory impact analysis must be 
prepared for final rules with economically significant effects (that 
is, a final rule that would have an annual effect on the economy of 
$100

[[Page 63253]]

million or more in any 1 year, or would adversely affect in a material 
way the economy, a sector of the economy, productivity, competition, 
jobs, the environment, public health or safety, or State, local, or 
tribal governments or communities).
    We have simulated the effect of the physician fee schedule changes 
that we are adopting in this final rule. We are making several changes 
to the physician fee schedule RVUs in this final rule. In general, 
section 1848(c)(2)(B)(ii)(II) requires that changes to RVUs cannot 
increase or decrease expenditures more than $20 million. Thus, changes 
to the RVUs made pursuant to section 1848(c)(2)(B)(ii)(II) must be 
budget neutral. That is, increases in payments resulting from RVU 
changes must be offset by decreases in payments for other services and 
there will be redistribution in payment among physicians, practitioners 
and suppliers that bill Medicare for physician fee schedule services. 
We expect that the changes we are making to the physician fee schedule 
RVUs under section 1848(c) will result in a redistribution of Medicare 
allowed charges of more than $100 million in one year. For this reason, 
we are considering this final rule to be economically significant. 
Therefore, this final rule is a major rule and we have prepared a 
regulatory impact analysis.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a Regulatory Flexibility 
Analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives and 
less significant adverse economic impact on the small entities.
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis for any final rule that may have a significant impact 
on the operations of a substantial number of small rural hospitals. 
This analysis must conform to the provisions of section 603 of the RFA. 
For purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside a Metropolitan 
Statistical Area and has fewer than 100 beds.
    For purposes of the RFA, physicians, non-physician practitioners, 
and suppliers are considered small businesses if they generate revenues 
of $6 million or less. Approximately 95 percent of physicians (except 
mental health specialists) are considered to be small entities. There 
are about 900,000 physicians, other practitioners and medical suppliers 
that receive Medicare payment under the physician fee schedule.
    The analysis and discussion provided in this section as well as 
elsewhere in this final rule complies with the RFA requirements. 
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires 
that agencies assess anticipated costs and benefits before issuing any 
rule that may result in expenditure in any 1 year by State, local, or 
tribal governments, in the aggregate, or by the private sector, of $110 
million. This final rule would not impose unfunded mandates on State, 
local, or tribal governments, or on the private sector of more than 
$110 million dollars.
    We have examined this final rule in accordance with Executive Order 
13132 and have determined that this regulation would not have any 
significant impact on the rights, roles, or responsibilities of State, 
local, or tribal governments.
    We have prepared the following analysis, which together with the 
rest of this preamble, meets all assessment requirements. It explains 
the rationale for, and purposes of, the rule, details the costs and 
benefits of the rule, analyzes alternatives, and presents the measures 
we propose to use to minimize the burden on small entities. As 
indicated elsewhere in this final rule, we are making changes to the 
Medicare Economic Index, refining resource-based practice based 
practice expense RVUs, creating new codes for dialysis patient visits 
to their physicians and making a variety of other changes to our 
regulations, payments or payment policy to ensure that our payment 
systems are updated to reflect changes in medical practice and the 
relative value of services. We provide information for each of the 
policy changes in the relevant sections in this final rule. While this 
rule revises the definition of diabetes for the purposes of outpatient 
diabetes self-management training, it does not impose reporting, 
record-keeping and other compliance requirements. We are unaware of any 
relevant Federal rules that duplicate, overlap or conflict with this 
proposed rule. The relevant sections of this final rule contain a 
description of significant alternatives.

A. Physician Fee Schedule Relative Value Units

    As indicated above, we are making changes to the work and practice 
expense RVUs under the provisions of section 1848(c)(2) of the Act and 
section 429(b) of BIPA. Under section 1848(c)(2) of the Act, 
adjustments to RVUs may not cause the amount of expenditures to differ 
by more than $20 million from the amount of expenditures that would 
have resulted without such adjustments. We are making several changes 
under section 1848(c)(2) that would result in a change of expenditures 
that would exceed $20 million threshold if we made no offsetting 
adjustments to either the conversion factor or RVUs.
    With respect to practice expense, our policy has been to meet the 
budget neutrality requirements in the statute by incorporating a 
rescaling adjustment in the practice expense methodology. That is, we 
estimate the aggregate number of practice expense relative values that 
will be paid under current and revised policy in CY 2004. We apply a 
uniform adjustment factor to make the aggregate number of revised 
practice expense relative values equal the estimated number that would 
be paid under current policy. We are applying this policy for all 
changes that we are making under section 1848(c).
    Table 26 shows the specialty level impact on payment of changes 
being made for CY 2004. The payment impacts reflect averages for each 
specialty based on Medicare utilization. The payment impact for an 
individual physician would be different from the average, based on the 
mix of services the physician provides. The average change in total 
revenues would be less than the impact displayed here since physicians 
furnish services to both Medicare and non-Medicare patients and 
specialties may receive substantial Medicare revenues for services that 
are not paid under the physician fee schedule. For instance, 
independent laboratories receive 17 of their revenues from physician 
schedule services and the remainder for laboratory fee schedule 
services that are unaffected by this rule. We modeled the impact of all 
changes to the relative value units and illustrated their effect in 
table 26. The column labeled ``NPRM'' shows the combined effect of all 
of the changes contained in the August 15, 2003 proposed rule (see 68 
FR 49033 to 49038 for a detailed discussion of each provision).
    The column labeled ``Practice Expense Refinements'' shows the 
impact on payment from further changes to the practice expense inputs 
that we made using information that became available to us since the 
proposed rule. In some cases, we made changes to the practice expense 
inputs in response to public comments. In other situations, we may have 
received

[[Page 63254]]

a price for an item of medical equipment or supplies where we 
previously did not have one. In most cases, these changes may increase 
or decrease the practice expense RVU for a given code but will have 
very little impact across all of the services provided by a specialty. 
However, in one case, we include prices for several items of equipment 
and supplies that are generally used by otolaryngologists. The addition 
of this new information increased payment for many procedural services 
provided by otolaryngologists and reduced payment for their diagnostic 
services. The net effect of these changes is to increase payments to 
otolaryngologists by the 1 percent shown in table x. Audiologists 
provide many of the same diagnostic services that are billed to 
Medicare by otolaryngologists resulting in the approximate 2 percent 
decrease in payment shown in table 26 for audiologists. Similarly, 
there may be some very small additional impact on allergy from the 
additional practice expense refinements. There were a number of coding 
changes made by CPT to central venous access codes. It is possible 
there may be small impact on payment from these coding changes for 
interventional radiology.
    The ``Practice Expense Refinements'' column also shows an increase 
in payment of 2 percent for radiation oncology and 1 percent for 
portable x-ray suppliers. These impacts are a result of our decision to 
use the non-physician work pool methodology to develop the practice 
expense RVUs for procedure code 77418 (Intensity Modulated Radiation 
Therapy).
    We also modeled the effect of adjusting the RVUs to match the new 
MEI weights. Because we are increasing the malpractice RVUs by 
approximately 20 percent, adjusting the RVUs to match the new MEI 
weights will result in an increase in payment for those specialties 
that perform services with high malpractice RVUs. Payments to cardiac 
surgery, neurosurgery, orthopedic surgery, thoracic surgery and 
vascular surgery will increase by approximately 1 percent. The column 
labeled ``Total'' shows the impact of all changes that we are making to 
the work and practice expense RVUs for 2004.

[[Page 63255]]



Table 26.--Impact of Physician Fee Schedule Changes on Total Medicare Allowed Charges by Physician, Practitioner
                                            and Supplier Subcategory
----------------------------------------------------------------------------------------------------------------
                                                                                        Adjusting
                                              Medicare                    Practice       RVUs to
                 Specialty                     allowed        NPRM         expense      match MEI       Total
                                               charges      (percent)    refinements     weights      (percent)
                                             (millions)                   (percent)     (percent)
----------------------------------------------------------------------------------------------------------------
Physicians:
    ALLERGY/IMMUNOLOGY....................          $153            -1            -1             0            -2
    ANESTHESIOLOGY........................         1,327             0             0             0             0
    CARDIAC SURGERY.......................           321             0             0             1             0
    CARDIOLOGY............................         5,759             0             0             0             0
    CLINICS...............................         1,167             0             0             0             0
    COLON AND RECTAL SURGERY..............           101             1             0             0             1
    CRITICAL CARE.........................           108            -1             0             0            -1
    DERMATOLOGY...........................         1,708             0             0             0             0
    EMERGENCY MEDICINE....................         1,444             0             0             0             0
    ENDOCRINOLOGY.........................           246             1             0             0             1
    FAMILY PRACTICE.......................         4,005             1             0             0             1
    GASTROENTEROLOGY......................         1,513            -1             0             0            -1
    GENERAL PRACTICE......................           954             0             0             0             0
    GENERAL SURGERY.......................         2,110            -1             0             0             0
    GERIATRICS............................            97            -1             1             0             0
    HAND SURGERY..........................            46            -2             0             0            -2
    HEMATOLOGY/ONCOLOGY...................         1,086             1             0             0             1
    INFECTIOUS DISEASE....................           336             0             0             0             0
    INTERNAL MEDICINE.....................         7,917             1             0             0             1
    INTERVENTIONAL RADIOLOGY..............           155             0            -1             0             0
    NEPHROLOGY............................         1,187             0             0             0             0
    NEUROLOGY.............................         1,072             1             0             0             1
    NEUROSURGERY..........................           433             0             0             1             1
    OBSTETRICS/GYNECOLOGY.................           550             1             0             0             1
    OPHTHALMOLOGY.........................         4,291            -1             0             0            -1
    ORTHOPEDIC SURGERY....................         2,645            -2             0             1            -1
    OTOLARNGOLOGY.........................           735             2             1             0             3
    PATHOLOGY.............................           799             0             0             0             0
    PEDIATRICS............................            58             0             0             0             0
    PHYSICAL MEDICINE.....................           594             1             0             0             1
    PLASTIC SURGERY.......................           274             0             0             0             0
    PSYCHIATRY............................         1,073             0             0             0             0
    PULMONARY DISEASE.....................         1,305            -1             0             0            -1
    RADIATION ONCOLOGY....................         1,002            -3             2             0             0
    RADIOLOGY.............................         4,230             0             0             0             0
    RHEUMATOLOGY..........................           352             1             0             0             1
    THORACIC SURGERY......................           446            -1             0             1             0
    UROLOGY...............................         1,540             2             0             0             1
    VASCULAR SURGERY......................           429            -1             0             1             0
Practitioners:
    AUDIOLOGIST...........................            25            -1            -2             1            -1
    CHIROPRACTOR..........................           589             0             0             0             0
    CLINICAL PSYCHOLOGIST.................           449             0             0             0             0
    CLINICAL SOCIAL WORKER................           277             0             0             0             0
    NURSE ANESTHETIST.....................           452             0             0             1             1
    NURSE PRACTITIONER....................           434            -1             1             0             0
    OPTOMETRY.............................           611             1             0             0             0
    ORAL/MAXILLOFACIAL SURGERY............            33             8             0             0             8
    PHYSICAL/OCCUPATIONAL THERAPY.........           835             0             0             1             0
    PHYSICIANS ASSISTANT..................           322             0             0             0             0
    PODIATRY..............................         1,307            -1             0             0            -1
Suppliers:
    DIAGNOSTIC TESTING FACILITY...........           728             0             0             0             0
    INDEPENDENT LABORATORY................           508             2             0             0             1
    PORTABLE X-RAY SUPPLIER...............            82            -1             1             0             0
Other:
    ALL OTHER.............................            54             0             0             0             0
    ALL PHYSICIAN FEE SCHEDULE............        60,385             0             0             0             0
----------------------------------------------------------------------------------------------------------------

    The statutory methodology for updating physician fee schedule 
conversion factor is specified in section 1848(d)(4) of the Act. 
Consistent with the requirements of section 1848(d)(4) of the Act, as 
explained in section VI of this final rule, we are reducing the 
physician fee schedule conversion factor by approximately 4.5 percent. 
In table 27, we are showing the estimated change in average payments by 
specialty based on provisions of this final rule

[[Page 63256]]

and the estimated physician fee schedule update.

       Table 27.--Impact of Physician Fee Schedule Changes on Total Medicare Allowed Charges by Physician,
        Practitioner, and Supplier Subcategory Including the Effect of the Physician Fee Schedule Update
----------------------------------------------------------------------------------------------------------------
                                                                                        Physician
                                                            Medicare     Impact  of        fee
                        Specialty                            allowed    RVU  changes    schedule        Total
                                                             charges      (percent)      update       (percent)
                                                           (millions)                   (percent)
----------------------------------------------------------------------------------------------------------------
Physicians:
    ALLERGY/IMMUNOLOGY..................................          $153            -2          -4.5            -6
    ANESTHESIOLOGY......................................         1,327             0          -4.5            -4
    CARDIAC SURGERY.....................................           321             0          -4.5            -4
    CARDIOLOGY..........................................         5,759             0          -4.5            -4
    CLINICS.............................................         1,167             0          -4.5            -4
    COLON AND RECTAL SURGERY............................           101             1          -4.5            -4
    CRITICAL CARE.......................................           108            -1          -4.5            -5
    DERMATOLOGY.........................................         1,708             0          -4.5            -5
    EMERGENCY MEDICINE..................................         1,444             0          -4.5            -4
    ENDOCRINOLOGY.......................................           246             1          -4.5            -4
    FAMILY PRACTICE.....................................         4,005             1          -4.5            -4
    GASTROENTEROLOGY....................................         1,513            -1          -4.5            -5
    GENERAL PRACTICE....................................           954             0          -4.5            -4
    GENERAL SURGERY.....................................         2,110             0          -4.5            -5
    GERIATRICS..........................................            97             0          -4.5            -5
    HAND SURGERY........................................            46            -2          -4.5            -7
    HEMATOLOGY/ONCOLOGY.................................         1,086             1          -4.5            -4
    INFECTIOUS DISEASE..................................           336             0          -4.5            -5
    INTERNAL MEDICINE...................................         7,917             1          -4.5            -4
    INTERVENTIONAL RADIOLOGY............................           155             0          -4.5            -5
    NEPHROLOGY..........................................         1,187             0          -4.5            -5
    NEUROLOGY...........................................         1,072             1          -4.5            -3
    NEUROSURGERY........................................           433             1          -4.5            -4
    OBSTETRICS/GYNECOLOGY...............................           550             1          -4.5            -4
    OPHTHALMOLOGY.......................................         4,291            -1          -4.5            -5
    ORTHOPEDIC SURGERY..................................         2,645            -1          -4.5            -6
    OTOLARNGOLOGY.......................................           735             3          -4.5            -2
    PATHOLOGY...........................................           799             0          -4.5            -4
    PEDIATRICS..........................................            58             0          -4.5            -4
    PHYSICAL MEDICINE...................................           594             1          -4.5            -4
    PLASTIC SURGERY.....................................           274             0          -4.5            -4
    PSYCHIATRY..........................................         1,073             0          -4.5            -5
    PULMONARY DISEASE...................................         1,305            -1          -4.5            -6
    RADIATION ONCOLOGY..................................         1,002             0          -4.5            -5
    RADIOLOGY...........................................         4,230             0          -4.5            -5
    RHEUMATOLOGY........................................           352             1          -4.5            -3
    THORACIC SURGERY....................................           446             0          -4.5            -4
    UROLOGY.............................................         1,540             1          -4.5            -3
    VASCULAR SURGERY....................................           429             0          -4.5            -5
Practitioners:
    AUDIOLOGIST.........................................            25            -1          -4.5            -6
    CHIROPRACTOR........................................           589             0          -4.5            -4
    CLINICAL PSYCHOLOGIST...............................           449             0          -4.5            -5
    CLINICAL SOCIAL WORKER..............................           277             0          -4.5            -5
    NURSE ANESTHETIST...................................           452             1          -4.5            -4
    NURSE PRACTITIONER..................................           434             0          -4.5            -4
    OPTOMETRY...........................................           611             0          -4.5            -4
    ORAL/MAXILLOFACIAL SURGERY..........................            33             8          -4.5             3
    PHYSICAL/OCCUPATIONAL THERAPY.......................           835             0          -4.5            -4
    PHYSICIANS ASSISTANT................................           322             0          -4.5            -4
    PODIATRY............................................         1,307            -1          -4.5            -5
Suppliers:
    DIAGNOSTIC TESTING FACILITY.........................           728             0          -4.5            -5
    INDEPENDENT LABORATORY..............................           508             1          -4.5            -3
    PORTABLE X-RAY SUPPLIER.............................            82             0          -4.5            -4
Other:
    ALL OTHER...........................................            54             0          -4.5            -4
    ALL PHYSICIAN FEE SCHEDULE..........................        60,385             0          -4.5            -4
----------------------------------------------------------------------------------------------------------------


[[Page 63257]]

    Table 28 shows the impact on payments for selected high volume 
procedures of all of the changes previously discussed. This table shows 
the combined impact of the change in the work, practice expense and 
malpractice RVUs and the estimated physician fee schedule update on 
total payment for the procedure. There are separate columns that show 
the change in the facility rates and the non-facility rates. For an 
explanation of facility and non-facility practice expense refer to 
Sec.  414.22(b)(5)(i).

  Table 28.--Impact of Final Rule and Physician Fee Schedule Update on Medicare Payment for Selected Procedures
----------------------------------------------------------------------------------------------------------------
                                                       Non-Facility                        Facility
      HCPCS          MOD         DESC       --------------------------------------------------------------------
                                                Old        New      % change      Old         New      % change
----------------------------------------------------------------------------------------------------------------
11721............  ......  Debride nail, 6      $37.52     $36.19         -4       29.06       28.11          -3
                            or more.
17000............  ......  Destroy benign/       61.43      57.27         -7       33.11       33.73           2
                            premlg lesion.
27130............  ......  Total hip               N/A        N/A        N/A    1,343.41    1,290.82          -4
                            arthroplasty.
27236............  ......  Treat thigh             N/A        N/A        N/A    1,068.99    1,024.86          -4
                            fracture.
27244............  ......  Treat thigh             N/A        N/A        N/A    1,155.44    1,050.15          -9
                            fracture.
27447............  ......  Total knee              N/A        N/A        N/A    1,445.67    1,390.25          -4
                            arthroplasty.
33533............  ......  CABG, arterial,         N/A        N/A        N/A    1,799.18    1,742.99          -3
                            single.
35301............  ......  Rechanneling of         N/A        N/A        N/A    1,073.77    1,043.83          -3
                            artery.
43239............  ......  Upper GI             337.69     305.31        -10      155.97      150.02          -4
                            endoscopy,
                            biopsy.
45385............  ......  Lesion removal       545.53     471.85        -14      290.61      271.23          -7
                            colonoscopy.
66821............  ......  After cataract       231.01     227.32         -2      214.83      224.15           4
                            laser surgery.
66984............  ......  Cataract surg w/        N/A        N/A        N/A      672.81      645.06          -4
                            iol, 1 stage.
67210............  ......  Treatment of         604.39     544.58        -10      548.47      528.41          -4
                            retinal lesion.
71010............      26  Chest x-ray.....       9.20       8.78         -5        9.20        8.78          -5
71020............      26  Chest x-ray.....      11.04      10.54         -5       11.04       10.54          -5
76091............  ......  Mammogram, both       94.17      89.94         -4         N/A         N/A         N/A
                            breasts.
76091............      26  Mammogram, both       44.14      42.16         -4       44.14       42.16          -4
                            breasts.
76092............  ......  Mammogram,            82.77      79.40         -4         N/A         N/A         N/A
                            screening.
76092............      26  Mammogram,            36.05      34.08         -5       36.05       34.08          -5
                            screening.
77427............  ......  Radiation tx         168.11     158.81         -6      168.11      158.81          -6
                            management, x5.
78465............      26  Heart image           75.41      71.67         -5       75.41       71.67          -5
                            (3d), multiple.
88305............      26  Tissue exam by        40.83      39.00         -4       40.83       39.00          -4
                            pathologist.
90801............  ......  Psy dx interview     148.98     141.94         -5      140.52      133.16          -5
90806............  ......  Psytx, off, 45-       96.38      91.70         -5       92.70       88.54          -4
                            50 min.
90807............  ......  Psytx, off, 45-      102.63      97.32         -5      100.06       95.21          -5
                            50 min w/e&m.
90862............  ......  Medication            50.76      48.13         -5       47.82       45.32          -5
                            management.
90935............  ......  Hemodialysis,           N/A        N/A        N/A       71.36       67.81          -5
                            one evaluation.
92004............  ......  Eye exam, new        123.60     119.46         -3       88.29       83.62          -5
                            patient.
92012............  ......  Eye exam              61.43      60.08         -2       36.05       34.08          -5
                            established pat.
92014............  ......  Eye exam &            91.60      88.19         -4       58.86       55.86          -5
                            treatment.
92980............  ......  Insert                  N/A        N/A        N/A      800.45      763.81          -5
                            intracoronary
                            stent.
92982............  ......  Coronary artery         N/A        N/A        N/A      594.46      566.71          -5
                            dilation.
93000............  ......  Electrocardiogra      26.12      24.95         -2         N/A         N/A         N/A
                            m, complete.
93010............  ......  Electrocardiogra       8.83       8.43         -5        8.83        8.43          -5
                            m report.
93015............  ......  Cardiovascular       104.10      99.78         -4         N/A         N/A         N/A
                            stress test.
93307............      26  Echo exam of          48.19      46.03         -4       48.19       46.03          -4
                            heart.
93510............      26  Left heart           231.38     237.86          3      231.38      237.86           3
                            catheterization.
98941............  ......  Chiropractic          35.68      34.08         -4       31.27       29.86          -5
                            manipulation.
99203............  ......  Office/               92.70      90.65         -2       70.26       67.46          -4
                            outpatient
                            visit, new.
99204............  ......  Office/              132.06     128.24         -3      103.74       99.08          -4
                            outpatient
                            visit, new.
99205............  ......  Office/              168.48     161.97         -4      137.58      130.70          -5
                            outpatient
                            visit, new.
99211............  ......  Office/               20.60      20.73          1        8.83        8.43          -5
                            outpatient
                            visit, est.
99212............  ......  Office/               36.42      36.19         -1       23.17       22.13          -4
                            outpatient
                            visit, est.
99213............  ......  Office/               51.13      49.89         -2       34.58       33.03          -4
                            outpatient
                            visit, est.
99214............  ......  Office/               79.82      77.29         -3       56.65       53.75          -5
                            outpatient
                            visit, est.
99215............  ......  Office/              116.98     112.43         -4       91.23       86.78          -5
                            outpatient
                            visit, est.
99221............  ......  Initial hospital        N/A        N/A        N/A       65.85       62.54          -5
                            care.
99222............  ......  Initial hospital        N/A        N/A        N/A      109.25      104.00          -5
                            care.
99223............  ......  Initial hospital        N/A        N/A        N/A      151.92      144.75          -5
                            care.
99231............  ......  Subsequent              N/A        N/A        N/A       32.74       31.27          -4
                            hospital care.
99232............  ......  Subsequent              N/A        N/A        N/A       54.07       51.30          -5
                            hospital care.
99233............  ......  Subsequent              N/A        N/A        N/A       76.88       73.43          -4
                            hospital care.
99236............  ......  Observ/hosp same        N/A        N/A        N/A      216.67      211.86          -2
                            date.
99238............  ......  Hospital                N/A        N/A        N/A       69.16       65.70          -5
                            discharge day.
99239............  ......  Hospital                N/A        N/A        N/A       93.80       89.24          -5
                            discharge day.
99241............  ......  Office                47.45      47.08         -1       33.11       31.97          -3
                            consultation.
99242............  ......  Office                88.29      86.08         -3       68.05       65.35          -4
                            consultation.
99243............  ......  Office               116.61     113.83         -2       90.49       86.43          -4
                            consultation.
99244............  ......  Office               165.90     160.91         -3      134.27      127.89          -5
                            consultation.
99245............  ......  Office               215.20     206.94         -4      177.67      169.35          -5
                            consultation.
99251............  ......  Initial                 N/A        N/A        N/A       34.95       33.73          -3
                            inpatient
                            consult.
99252............  ......  Initial                 N/A        N/A        N/A       70.26       67.46          -4
                            inpatient
                            consult.
99253............  ......  Initial                 N/A        N/A        N/A       96.01       91.35          -5
                            inpatient
                            consult.

[[Page 63258]]


99254............  ......  Initial                 N/A        N/A        N/A      137.95      131.05          -5
                            inpatient
                            consult.
99255............  ......  Initial                 N/A        N/A        N/A      189.81      180.94          -5
                            inpatient
                            consult.
99261............  ......  Follow-up               N/A        N/A        N/A       22.07       20.73          -6
                            inpatient
                            consult.
99262............  ......  Follow-up               N/A        N/A        N/A       43.77       42.16          -4
                            inpatient
                            consult.
99263............  ......  Follow-up               N/A        N/A        N/A       65.11       62.19          -4
                            inpatient
                            consult.
99282............  ......  Emergency dept          N/A        N/A        N/A       26.85       26.00          -3
                            visit.
99283............  ......  Emergency dept          N/A        N/A        N/A       60.33       57.62          -4
                            visit.
99284............  ......  Emergency dept          N/A        N/A        N/A       94.17       89.94          -4
                            visit.
99285............  ......  Emergency dept          N/A        N/A        N/A      146.77      140.18          -4
                            visit.
99291............  ......  Critical care,       210.05     229.07          9      200.11      191.13          -4
                            first hour.
99292............  ......  Critical care,       107.78     101.19         -6      100.06       95.21          -5
                            add'l 30 min.
99301............  ......  Nursing facility      71.00      67.46         -5       61.06       57.97          -5
                            care.
99302............  ......  Nursing facility      96.75      92.05         -5       81.30       77.65          -4
                            care.
99303............  ......  Nursing facility     119.92     114.19         -5      101.16       96.27          -5
                            care.
99311............  ......  Nursing fac           40.83      39.00         -4       30.53       28.81          -6
                            care, subseq.
99312............  ......  Nursing fac           62.54      59.38         -5       50.40       48.13          -5
                            care, subseq.
99313............  ......  Nursing fac           85.71      81.16         -5       71.73       68.16          -5
                            care, subseq.
99348............  ......  Home visit, est       74.31      70.62         -5         N/A         N/A         N/A
                            patient.
99350............  ......  Home visit, est      167.74     160.21         -4         N/A         N/A         N/A
                            patient.
G0317............  ......  ESRDrelsvc 4+/       262.28     285.29          9      262.28      285.29           9
                            mo; 20+yr.
G0318............  ......  ESRDrelsvc 2-3/      262.28     237.51         -9      262.28      237.51          -9
                            mo; 20+yr.
G0319............  ......  ESRDrelsvc 1/mo;     262.28     190.07        -28      262.28      190.07         -28
                            20+yr.
----------------------------------------------------------------------------------------------------------------

B. Geographic Practice Cost Index Changes

    Section 1848(e)(1)(A) of the Act requires that payments under the 
Medicare physician fee schedule vary among payment areas only to the 
extent that area costs vary as reflected by the area GPCIs. The GPCIs 
measure areas cost differences in the three components of the physician 
fee schedule: Physician work, practice expenses, and malpractice 
insurance. Section 1848(e)(1)(C) of the Act requires that the GPCIs be 
reviewed and, if necessary, revised at least every 3 years. Due to 
problems with the availability of U.S. Census Bureau data, which is the 
major resource utilized in both the work and practice expense GPCIs, we 
have updated only the malpractice GPCI in this regulation.
    The first GPCI revision was implemented in 1995. The second 
revision was implemented in 1998. The third revision was implemented in 
2001. This constitutes the fourth revision to the GPCIs. Section 
1848(e)(1)(C) of the Act also requires that GPCI revisions be phased in 
equally over a 2-year period if more than one year has elapsed since 
the last adjustment.
    In order to mitigate the volatility associated with malpractice 
insurance premiums, we reduced the percent change in the malpractice 
GPCIs by a factor of 50 percent. As directed by the statute, we will 
implement \1/2\ of this change in the first year (CY 2004) and \1/2\ of 
this change in the second year (CY 2005). During this two-year phase-
in, we will continue to work with the State Departments of Insurance to 
obtain the most current malpractice premium data available. As more 
current data are obtained, we will review and revise the malpractice 
GPCIs as appropriate.
    An estimate of the 2004 proposed malpractice GPCI changes can be 
demonstrated by a comparison of area geographic adjustment factors 
(GAFs). The GAFs are a weighted composite of each area's work, practice 
expense, and malpractice expense GPCIs using the national GPCI cost 
share weights. While we do not actually use the GAFs in computing the 
fee schedule payment for a specific service, they are useful in 
comparing overall area costs and payments. The actual effect on payment 
for any specific service will deviate from the GAF to the extent that 
the service's proportions of work, practice expenses, and malpractice 
expense RVUs differ from those of the GAF. Table 27 shows the estimated 
effects of the revised 2004 malpractice GPCIs on area GAFs. As directed 
by statute, the 2004 GAFs reflect only \1/2\ of the impact of the 
revision to the malpractice GPCIs.
    With the exception of Detroit, Michigan, no locality experienced an 
increase of more than 1 percent in total payments due to the revision 
of their malpractice GPCI for 2004. Alternatively, locality specific 
decreases in total payments due to the revision of the malpractice 
GPCIs do not exceed 1 percent for any given locality in 2004.

                        Table 29.--Revised Geographic Adjustment Factors from Final Rule
----------------------------------------------------------------------------------------------------------------
                                        Locality                                                       Percent
            Carrier  No.                  No.           Locality name       2003  GAF    2004  GAF    difference
----------------------------------------------------------------------------------------------------------------
00510...............................           00  Alabama...............        0.927        0.923         -0.4
00831...............................           01  Alaska................        1.115        1.113         -0.1
00832...............................           00  Arizona...............        0.991        0.991          0.0
00520...............................           13  Arkansas..............        0.889        0.885         -0.4
31146...............................           26  Anaheim/Santa Ana, CA.        1.096        1.098          0.1
31146...............................           18  Los Angeles, CA.......        1.088        1.088          0.0
31140...............................           03  Marin/Napa/Solano, CA.        1.103        1.104          0.0
31140...............................           07  Oakland/Berkeley, CA..        1.112        1.111          0.0

[[Page 63259]]


31140...............................           05  San Francisco, CA.....        1.221        1.223          0.2
31140...............................           06  San Mateo, CA.........        1.199        1.201          0.2
31140...............................           09  Santa Clara, CA.......        1.184        1.184          0.1
31146...............................           17  Ventura, CA...........        1.061        1.060         -0.1
31146...............................           99  Rest of California*...        1.010        1.008         -0.2
31140...............................           99  Rest of California*...        1.010        1.008         -0.2
00824...............................           01  Colorado..............        0.983        0.982         -0.2
00591...............................           00  Connecticut...........        1.092        1.092          0.0
00902...............................           01  Delaware..............        1.016        1.018          0.2
00903...............................           01  DC + MD/VA Suburbs....        1.094        1.095          0.1
00590...............................           03  Fort Lauderdale, FL...        1.034        1.036          0.3
00590...............................           04  Miami, FL.............        1.079        1.085          0.5
00590...............................           99  Rest of Florida.......        0.972        0.974          0.2
00511...............................           01  Atlanta, GA...........        1.026        1.027          0.1
00511...............................           99  Rest of Georgia.......        0.936        0.935         -0.1
00833...............................           01  Hawaii/Guam...........        1.046        1.046          0.0
05130...............................           00  Idaho.................        0.912        0.907         -0.5
00952...............................           16  Chicago, IL...........        1.079        1.087          0.7
00952...............................           12  East St. Louis, IL....        0.983        0.988          0.5
00952...............................           15  Suburban Chicago, IL..        1.054        1.059          0.5
00952...............................           99  Rest of Illinois......        0.939        0.940          0.1
00630...............................           00  Indiana...............        0.940        0.935         -0.5
00826...............................           00  Iowa..................        0.912        0.909         -0.4
00650...............................           00  Kansas *..............        0.928        0.925         -0.3
00740...............................           02  Kansas *..............        0.928        0.925         -0.3
00660...............................           00  Kentucky..............        0.923        0.921         -0.2
00528...............................           01  New Orleans, LA.......        0.985        0.984          0.0
00528...............................           99  Rest of Louisiana.....        0.930        0.929         -0.1
31142...............................           03  Southern Maine........        0.977        0.975         -0.2
31142...............................           99  Rest of Maine.........        0.930        0.927         -0.3
00901...............................           01  Baltimore/Surr. Cntys,        1.025        1.025          0.0
                                                    MD.
00901...............................           99  Rest of Maryland......        0.972        0.970         -0.2
31143...............................           01  Metropolitan Boston...        1.117        1.118          0.2
31143...............................           99  Rest of Massachusetts.        1.053        1.054          0.1
00953...............................           01  Detroit, MI...........        1.095        1.106          1.0
00953...............................           99  Rest of Michigan......        0.990        0.992          0.2
00954...............................           00  Minnesota.............        0.966        0.962         -0.5
00512...............................           00  Mississippi...........        0.900        0.896         -0.4
00740...............................           04  Metropolitan Kansas           0.974        0.975          0.1
                                                    City, MO.
00523...............................           01  Metropolitan St.              0.965        0.966          0.0
                                                    Louis, MO.
00740...............................           99  Rest of Missouri *....        0.890        0.889         -0.1
00523...............................           99  Rest of Missouri *....        0.890        0.889         -0.1
00751...............................           01  Montana...............        0.912        0.913          0.1
00655...............................           00  Nebraska..............        0.902        0.898         -0.4
00834...............................           00  Nevada................        1.026        1.025         -0.1
31144...............................           40  New Hampshire.........        0.999        1.001          0.2
00805...............................           01  Northern NJ...........        1.109        1.111          0.2
00805...............................           99  Rest of New Jersey....        1.058        1.060          0.2
00521...............................           05  New Mexico............        0.940        0.938         -0.2
00803...............................           01  Manhattan, NY.........        1.221        1.225          0.3
00803...............................           02  Nyc Suburbs/Long I.,          1.174        1.179          0.4
                                                    NY.
00803...............................           03  Poughkpsie/N Nyc              1.046        1.047          0.1
                                                    Suburbs, NY.
14330...............................           04  Queens, NY............        1.156        1.161          0.4
00801...............................           99  Rest of New York......        0.968        0.964         -0.4
05535...............................           00  North Carolina........        0.941        0.939         -0.2
00820...............................           01  North Dakota..........        0.911        0.907         -0.4
00883...............................           00  Ohio..................        0.968        0.968          0.0
00522...............................           00  Oklahoma..............        0.912        0.907         -0.7
00835...............................           01  Portland, OR..........        1.000        0.998         -0.3
00835...............................           99  Rest of Oregon........        0.932        0.929         -0.4
00865...............................           01  Metropolitan                  1.064        1.067          0.3
                                                    Philadelphia, PA.
00865...............................           99  Rest of Pennsylvania..        0.957        0.955         -0.2
00973...............................           20  Puerto Rico...........        0.790        0.784         -0.8
00870...............................           01  Rhode Island..........        1.033        1.033          0.0
00880...............................           01  South Carolina........        0.922        0.919         -0.4
00820...............................           02  South Dakota..........        0.894        0.889         -0.6
05440...............................           35  Tennessee.............        0.931        0.928         -0.3
00900...............................           31  Austin, TX............        0.986        0.988          0.2
00900...............................           20  Beaumont, TX..........        0.960        0.960          0.0
00900...............................           09  Brazoria, TX..........        0.997        0.999          0.1
00900...............................           11  Dallas, TX............        1.031        1.033          0.3

[[Page 63260]]


00900...............................           28  Fort Worth, TX........        0.983        0.985          0.2
00900...............................           15  Galveston, TX.........        0.991        0.992          0.1
00900...............................           18  Houston, TX...........        1.025        1.026          0.1
00900...............................           99  Rest of Texas.........        0.929        0.932          0.2
00910...............................           09  Utah..................        0.951        0.948         -0.2
31145...............................           50  Vermont...............        0.965        0.962         -0.3
00973...............................           50  Virgin Islands........        0.991        0.992          0.1
00904...............................           00  Virginia..............        0.949        0.947         -0.2
00836...............................           02  Seattle (King Cnty),          1.038        1.038          0.0
                                                    WA.
00836...............................           99  Rest of Washington....        0.971        0.970         -0.1
00884...............................           16  West Virginia.........        0.929        0.933          0.5
00951...............................           00  Wisconsin.............        0.958        0.954         -0.4
00825...............................           21  Wyoming...............        0.938        0.936         -0.2
----------------------------------------------------------------------------------------------------------------

C. Tracking Codes

    We are adopting a policy that will allow CMS to create national 
payment policy and determine national payment amounts for CPT tracking 
codes regardless of whether a national coverage determination for a 
specific service has been made. Our policy will have no effect on 
Medicare expenditures but will allow for more flexibility in 
determining payment rates for new services.

D. G Codes for Managing Dialysis Patients

    As previously discussed in section II.D., we have reviewed our 
current payment policy for the monthly dialysis capitation payment in 
response to concerns that have been raised over whether our payment 
policy is consistent with current medical practice. We are establishing 
new G codes for these services and are aligning Medicare's payment to 
recognize the higher amount of physician work associated with more 
frequent face-to-face visits. Aggregated Medicare payments to 
physicians for treating dialysis patients will not be increased or 
decreased by the establishment of these new procedure codes. Relative 
to payment based on the current CPT codes, Medicare payments to 
physicians for providing fewer than four visits per month will 
decrease. If the physician provides four or more visits per month, 
payment will increase. The net effect of these payment changes will not 
increase or decrease aggregate Medicare payment for physician services 
provided to dialysis patients.

E. Rebasing and Revising the MEI

    Section IV.B. of this final rule discusses rebasing and revising 
the MEI for the CY 2004 physician fee schedule. Substituting the 2000 
MEI weights in place of the 1996 weights increases the MEI by 0.1 
percent for 2004. After 2004, the MEI in some years is likely to be 
unaffected by using more recent year weights while other years may have 
slightly higher increases (between 0.1 to 0.2 percentage points).

F. Definition of Diabetes for Diabetes Self-Management Training

    In section III.A., we revised the definition of diabetes for 
purposes of the Outpatient Diabetes Self-Management Training benefit 
and are using this definition to determine beneficiary eligibility for 
Medical Nutrition Therapy when the beneficiary has a diagnosis of 
diabetes. The streamlining of the beneficiary eligibility requirements 
for Outpatient Diabetes Self-Management Training will reduce 
administrative burden for the referring physician or qualified non-
physician practitioner and for the accredited Outpatient Diabetes Self-
Management Training programs by simplifying documentation requirements 
and eliminating the need for reconsiderations and appeals to clarify 
that the requirements have been met. As indicated in the February 28, 
2003 Federal Register (68 FR 9572), we incorporated an adjustment to 
the SGR consistent with our original estimates of expenditures 
associated with this new benefit. Our experience is that expenditures 
have been less than originally estimated. We expect that simplifying 
administrative requirements associated with this new benefit will make 
it more likely that expenditures for diabetes self-management training 
will be consistent with original estimates and there will be no 
increase in Medicare expenditures from making these modifications.

G. Payment Policies for Anesthesia Services

    In section III.D. of this final rule, we discussed Medicare payment 
for anesthesia services involving anesthesiologists and residents. 
Effective January 1, 2004, we are revising our teaching anesthesia 
rules to allow teaching anesthesiologists to bill, similar to teaching 
CRNAs, for their involvement in two concurrent cases with residents. 
The policy change will allow anesthesiologists to be paid either under 
the rules for medical direction or the same way that teaching CRNAs are 
paid for two concurrent cases. We are uncertain how the practice 
arrangements of teaching anesthesiologists will change as a result of 
this new policy. We believe that most teaching anesthesiologists will 
continue to function under the medical direction practice model for 
concurrent cases involving residents. Therefore, we believe there will 
be minimal change in Medicare program expenditures as a result of this 
change.

H. Alternatives Considered

    This proposed rule contains a range of policies. The preamble 
identifies those policies when discretion has been exercised and 
presents rationale for our decisions, including a presentation of 
nonselected options.

I. Impact on Beneficiaries

    Although changes in physicians' payments were large when the 
physician fee schedule was implemented in 1992, we detected no problems 
with beneficiary access to care. While it has been suggested that the 
negative update for 2004 may affect beneficiary access to care, we note 
that the formula to determine this update is set by statute and this 
regulation cannot, and does not, change it. Nevertheless, we remain 
concerned about the issue and will continue to study the issue to the 
best of our ability with available resources.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

[[Page 63261]]

List of Subjects

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases,

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.

0
For the reasons set forth in the preamble, the Centers for Medicare & 
Medicaid Services amends 42 CFR chapter IV as follows:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
1. The authority citation for part 410 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


0
2. Section 410.130 is amended by revising the definition of 
``Diabetes'' to read as follows:


Sec.  410.130  Definitions

* * * * *
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism diagnosed using the following criteria: A fasting blood 
sugar greater than or equal to 126 mg/dL on two different occasions; a 
2 hour post-glucose challenge greater than or equal to 200 mg/dL on 2 
different occasions; or a random glucose test over 200 mg/dL for a 
person with symptoms of uncontrolled diabetes.
* * * * *

0
3. Section 410.140 is amended by adding the definition of ``Diabetes'' 
in alphabetical order to read as follows:


Sec.  410.140  Definitions

* * * * *
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism diagnosed using the following criteria: A fasting blood 
sugar greater than or equal to 126 mg/dL on two different occasions; a 
2 hour post-glucose challenge greater than or equal to 200 mg/dL on 2 
different occasions; or a random glucose test over 200 mg/dL for a 
person with symptoms of uncontrolled diabetes.
* * * * *

0
4. Section 410.141 is amended by revising paragraph (d) to read as 
follows:


Sec.  410.141  Outpatient diabetes self-management training.

* * * * *
    (d) Beneficiaries who may be covered. Medicare Part B covers 
outpatient diabetes self-management training for a beneficiary who has 
been diagnosed with diabetes.
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
1. The authority citation for part 414 continues to read as follows:

    Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).


0
2. Section 414.22(b)(6)(iii) is revised to read as follows:


Sec.  414.22  Relative value units (RVUs).

* * * * *
    (b) * * *
    (6) * * *
    (iii) CMS will consider for use in determining practice expense 
RVUs for the physician fee schedule survey data and related materials 
submitted to CMS by March 1, 2004 to determine CY 2005 practice expense 
RVUs and by March 1, 2005 to determine CY 2006 practice expense RVUs.
* * * * *

0
3. Section 414.46 is amended to--
0
a. Redesignate paragraphs (e) through (g) as paragraphs (f) through 
(h), respectively.
0
b. Add new paragraph (e).
0
The addition reads as follows:


Sec.  414.46  Additional rules for payment of anesthesia services.

* * * * *
    (e) Physicians involved with two concurrent cases with residents. 
The physician can bill base units and time units based on the amount of 
time the physician is actually present with the resident during each of 
two concurrent cases furnished on or after January 1, 2004.
    (1) To bill the base units, the physician must be present with the 
resident during the pre- and post-anesthesia care included in the base 
units.
    (2) If the physician is not present with the resident during pre- 
and post-anesthesia care, then the physician may bill the case as a 
medically directed case in accordance with paragraph (d) of this 
section.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: October 28, 2003.
Thomas A Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: October 28, 2003.
Tommy G. Thompson,
Secretary.

    Note: These addenda will not appear in the Code of Federal 
Regulations.

Addendum A--Explanation and Use of Addenda B

    The addenda on the following pages provide various data 
pertaining to the Medicare fee schedule for physicians' services 
furnished in 2003. Addendum B contains the RVUs for work, non-
facility practice expense, facility practice expense, and 
malpractice expense, and other information for all services included 
in the physician fee schedule.
    In previous years, we have listed many services in Addendum B 
that are not paid under the physician fee schedule. To avoid 
publishing as many pages of codes for these services, we are not 
including clinical laboratory codes and most alphanumeric codes 
(Healthcare Common Procedure Coding System (HCPCS) codes not 
included in CPT) in Addendum B.

Addendum B--2003 Relative Value Units and Related Information Used in 
Determining Medicare Payments for 2003

    This addendum contains the following information for each CPT 
code and alphanumeric HCPCS code, except for alphanumeric codes 
beginning with B (enteral and parenteral therapy), E (durable 
medical equipment), K (temporary codes for non-physicians' services 
or items), or L (orthotics), and codes for anesthesiology.
    1. CPT/HCPCS code. This is the CPT or alphanumeric HCPCS number 
for the service. Alphanumeric HCPCS codes are included at the end of 
this addendum.
    2. Modifier. A modifier is shown if there is a technical 
component (modifier TC) and a professional component (PC) (modifier 
-26) for the service. If there is a PC and a TC for the service, 
Addendum B contains three entries for the code: One for the global 
values (both professional and technical); one for modifier -26 (PC); 
and one for modifier TC. The global service is not designated by a 
modifier, and physicians must bill using the code without a modifier 
if the physician furnishes both the PC and the TC of the service.
    Modifier -53 is shown for a discontinued procedure. There will 
be RVUs for the code (CPT code 45378) with this modifier.
    3. Status indicator. This indicator shows whether the CPT/HCPCS 
code is in the physician fee schedule and whether it is separately 
payable if the service is covered.
    A = Active code. These codes are separately payable under the 
fee schedule if covered. There will be RVUs for codes with this 
status. The presence of an ``A'' indicator does not mean that 
Medicare has made a national decision regarding the coverage of

[[Page 63262]]

the service. Carriers remain responsible for coverage decisions in 
the absence of a national Medicare policy.
    B = Bundled code. Payment for covered services is always bundled 
into payment for other services not specified. If RVUs are shown, 
they are not used for Medicare payment. If these services are 
covered, payment for them is subsumed by the payment for the 
services to which they are incident. (An example is a telephone call 
from a hospital nurse regarding care of a patient.)
    C = Carrier-priced code. Carriers will establish RVUs and 
payment amounts for these services, generally on a case-by-case 
basis following review of documentation, such as an operative 
report.
    D = Deleted code. These codes are deleted effective with the 
beginning of the calendar year.
    E = Excluded from physician fee schedule by regulation. These 
codes are for items or services that we chose to exclude from the 
physician fee schedule payment by regulation. No RVUs are shown, and 
no payment may be made under the physician fee schedule for these 
codes. Payment for them, if they are covered, continues under 
reasonable charge or other payment procedures.
    F = Deleted/discontinued codes. Code not subject to a 90-day 
grace period.
    G = Code not valid for Medicare purposes. Medicare does not 
recognize codes assigned this status. Medicare uses another code for 
reporting of, and payment for, these services.
    H = Deleted modifier. Either the TC or PC component shown for 
the code has been deleted, and the deleted component is shown in the 
data base with the H status indicator. (Code subject to a 90-day 
grace period.)
    I = Not valid for Medicare purposes. Medicare uses another code 
for the reporting of, and the payment for, these services. (Code NOT 
subject to a 90-day grace period.)
    N = Non-covered service. These codes are non-covered services. 
Medicare payment may not be made for these codes. If RVUs are shown, 
they are not used for Medicare payment.
    P = Bundled or excluded code. There are no RVUs for these 
services. No separate payment should be made for them under the 
physician fee schedule.

--If the item or service is covered as incident to a physician's 
service and is furnished on the same day as a physician's service, 
payment for it is bundled into the payment for the physician's 
service to which it is incident (an example is an elastic bandage 
furnished by a physician incident to a physician's service).
--If the item or service is covered as other than incident to a 
physician's service, it is excluded from the physician fee schedule 
(for example, colostomy supplies) and is paid under the other 
payment provisions of the Act.

    R = Restricted coverage. Special coverage instructions apply. If 
the service is covered and no RVUs are shown, it is carrier-priced.
    T = Injections. There are RVUs for these services, but they are 
only paid if there are no other services payable under the physician 
fee schedule billed on the same date by the same provider. If any 
other services payable under the physician fee schedule are billed 
on the same date by the same provider, these services are bundled 
into the service(s) for which payment is made.
    X = Exclusion by law. These codes represent an item or service 
that is not within the definition of ``physicians' services'' for 
physician fee schedule payment purposes. No RVUs are shown for these 
codes, and no payment may be made under the physician fee schedule. 
(Examples are ambulance services and clinical diagnostic laboratory 
services.)
    4. Description of code. This is an abbreviated version of the 
narrative description of the code.
    5. Physician work RVUs. These are the RVUs for the physician 
work for this service in 2003. Codes that are not used for Medicare 
payment are identified with a ``+''.
    6. Facility practice expense RVUs. These are the fully 
implemented resource-based practice expense RVUs for facility 
settings.
    7. Non-facility practice expense RVUs. These are the fully 
implemented resource-based practice expense RVUs for non-facility 
settings.
    8. Malpractice expense RVUs. These are the RVUs for the 
malpractice expense for the service for 2003.
    9. Facility total. This is the sum of the work, fully 
implemented facility practice expense, and malpractice expense RVUs.
    10. Non-facility total. This is the sum of the work, fully 
implemented non-facility practice expense, and malpractice expense 
RVUs.
    11. Global period. This indicator shows the number of days in 
the global period for the code (0, 10, or 90 days). An explanation 
of the alpha codes follows:
    MMM = The code describes a service furnished in uncomplicated 
maternity cases including antepartum care, delivery, and postpartum 
care. The usual global surgical concept does not apply. See the 1999 
Physicians' Current Procedural Terminology for specific definitions.
    XXX = The global concept does not apply.
    YYY = The global period is to be set by the carrier (for 
example, unlisted surgery codes).
    ZZZ = Code related to another service that is always included in 
the global period of the other service. (Note: Physician work and 
practice expense are associated with intra-service time and in some 
instances the post-service time.)
    --------------------
\1\ CPT codes and descriptions only are copyright 2003 American Medical 
Association. All Rights Reserved. Applicable FARS/DFARS Apply.

\2\ Copyright 2003 American Dental Association. All rights reserved.

\3\ +Indicates RVUs are not used for Medicare payment.

[[Page 63262]]



                                            Addendum B.--Relative Value Units (RVUS) and Related Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Physician     Non-                               Non-
 CPT\1\/HCPCS\2\        MOD            Status            Description          work     facility   Facility  Malpractice   facility   Facility    Global
                                                                            RVUs\3\    PE RVUs    PE RVUs       RVUs       Total      total
--------------------------------------------------------------------------------------------------------------------------------------------------------
0001T............  .............  C                Endovas repr abdo ao         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    aneurys.
0002T............  .............  D                endo repair abd aa           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    aorto uni.
0003T............  .............  C                Cervicography.........       0.00       0.00       0.00        0.00        0.00       0.00        XXX
0005T............  .............  C                Perc cath stent/brain        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    cv art.
0006T............  .............  C                Perc cath stent/brain        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    cv art.
0007T............  .............  C                Perc cath stent/brain        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    cv art.
0008T............  .............  C                Upper gi endoscopy w/        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    suture.
0009T............  .............  C                Endometrial                  0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    cryoablation.
0010T............  .............  C                Tb test, gamma               0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    interferon.
0012T............  .............  C                Osteochondral knee           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    autograft.
0013T............  .............  C                Osteochondral knee           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    allograft.
0014T............  .............  C                Meniscal transplant,         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    knee.
0016T............  .............  C                Thermotx choroid vasc        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    lesion.
0017T............  .............  C                Photocoagulat macular        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    drusen.
0018T............  .............  C                Transcranial magnetic        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    stimul.
0019T............  .............  I                Extracorp shock wave         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    tx, ms.
0020T............  .............  C                Extracorp shock wave         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    tx, ft.
0021T............  .............  C                Fetal oximetry,              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    trnsvag/cerv.
0023T............  .............  C                Phenotype drug test,         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    hiv 1.
0024T............  .............  C                Transcath cardiac            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    reduction.
0025T............  .............  D                Ultrasonic pachymetry.       0.00       0.00       0.00        0.00        0.00       0.00        XXX
0026T............  .............  C                Measure remnant              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    lipoproteins.

[[Page 63263]]


0027T............  .............  C                Endoscopic epidural          0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    lysis.
0028T............  .............  C                Dexa body composition        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    study.
0029T............  .............  C                Magnetic tx for              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    incontinence.
0030T............  .............  C                Antiprothrombin              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    antibody.
0031T............  .............  C                Speculoscopy..........       0.00       0.00       0.00        0.00        0.00       0.00        XXX
0032T............  .............  C                Speculoscopy w/direct        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    sample.
0033T............  .............  C                Endovasc taa repr incl       0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    subcl.
0034T............  .............  C                Endovasc taa repr w/o        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    subcl.
0035T............  .............  C                Insert endovasc              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    prosth, taa.
0036T............  .............  C                Endovasc prosth, taa,        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    add-on.
0037T............  .............  C                Artery transpose/            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    endovas taa.
0038T............  .............  C                Rad endovasc taa rpr w/      0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    cover.
0039T............  .............  C                Rad s/i, endovasc taa        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    repair.
0040T............  .............  C                Rad s/i, endovasc taa        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    prosth.
0041T............  .............  C                Detect ur infect agnt        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    w/cpas.
0042T............  .............  C                Ct perfusion w/              0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    contrast, cbf.
0043T............  .............  C                Co expired gas               0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    analysis.
0044T............  .............  C                Whole body photography       0.00       0.00       0.00        0.00        0.00       0.00        XXX
0045T............  .............  C                Whole body photography       0.00       0.00       0.00        0.00        0.00       0.00        XXX
0046T............  .............  C                Cath lavage, mammary         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    duct(s.
0047T............  .............  C                Cath lavage, mammary         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    duct(s).
0048T............  .............  C                Implant ventricular          0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    device.
0049T............  .............  C                External circulation         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    assist.
0050T............  .............  C                Removal circulation          0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    assist.
0051T............  .............  C                Implant total heart          0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    system.
0052T............  .............  C                Replace component            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    heart syst.
0053T............  .............  C                Replace component            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    heart syst.
0054T............  .............  C                Bone surgery using           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    computer.
0055T............  .............  C                Bone surgery using           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    computer.
0056T............  .............  C                Bone surgery using           0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    computer.
0057T............  .............  C                Uppr gi scope w/ thrml       0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    txmnt.
0058T............  .............  C                Cryopreservation,            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    ovary tiss.
0059T............  .............  C                Cryopreservation,            0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    oocyte.
0060T............  .............  C                Electrical impedance         0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    scan.
0061T............  .............  C                Destruction of tumor,        0.00       0.00       0.00        0.00        0.00       0.00        XXX
                                                    breast.
10021............  .............  A                Fna w/o image.........       1.26       2.22       0.55        0.08        3.56       1.89        XXX
10022............  .............  A                Fna w/image...........       1.26       2.65       0.43        0.06        3.97       1.75        XXX
10040............  .............  A                Acne surgery..........       1.17       1.02       0.68        0.06        2.25       1.91        010
10060............  .............  A                Drainage of skin             1.16       1.22       0.95        0.10        2.48       2.21        010
                                                    abscess.
10061............  .............  A                Drainage of skin             2.39       1.84       1.53        0.20        4.43       4.12        010
                                                    abscess.
10080............  .............  A                Drainage of pilonidal        1.16       3.19       1.16        0.11        4.46       2.43        010
                                                    cyst.
10081............  .............  A                Drainage of pilonidal        2.44       4.16       1.53        0.23        6.83       4.20        010
                                                    cyst.
10120............  .............  A                Remove foreign body...       1.21       1.48       0.42        0.12        2.81       1.75        010
10121............  .............  A                Remove foreign body...       2.67       3.36       1.91        0.30        6.33       4.88        010
10140............  .............  A                Drainage of hematoma/        1.52       1.53       0.91        0.18        3.23       2.61        010
                                                    fluid.
10160............  .............  A                Puncture drainage of         1.19       0.73       0.47        0.13        2.05       1.79        010
                                                    lesion.
10180............  .............  A                Complex drainage,            2.24       3.27       2.09        0.30        5.81       4.63        010
                                                    wound.
11000............  .............  A                Debride infected skin.       0.60       0.58       0.22        0.06        1.24       0.88        000
11001............  .............  A                Debride infected skin        0.30       0.23       0.11        0.02        0.55       0.43        ZZZ
                                                    add-on.
11010............  .............  A                Debride skin, fx......       4.18       6.80       2.35        0.54       11.52       7.07        010
11011............  .............  A                Debride skin/muscle,         4.92       8.12       2.39        0.64       13.68       7.95        000
                                                    fx.
11012............  .............  A                Debride skin/muscle/         6.84      12.02       3.90        1.07       19.93      11.81        000
                                                    bone, fx.
11040............  .............  A                Debride skin, partial.       0.50       0.52       0.21        0.06        1.08       0.77        000
11041............  .............  A                Debride skin, full....       0.82       0.65       0.33        0.07        1.54       1.22        000
11042............  .............  A                Debride skin/tissue...       1.11       0.98       0.47        0.11        2.20       1.69        000
11043............  .............  A                Debride tissue/muscle.       2.37       3.47       2.63        0.29        6.13       5.29        010
11044............  .............  A                Debride tissue/muscle/       3.04       4.58       3.80        0.41        8.03       7.25        010
                                                    bone.
11055............  .............  R                Trim skin lesion......       0.43       0.56       0.17        0.02        1.01       0.62        000
11056............  .............  R                Trim skin lesions, 2         0.61       0.64       0.24        0.04        1.29       0.89        000
                                                    to 4.
11057............  .............  R                Trim skin lesions,           0.79       0.73       0.31        0.05        1.57       1.15        000
                                                    over 4.
11100............  .............  A                Biopsy, skin lesion...       0.81       1.27       0.37        0.05        2.13       1.23        000
11101............  .............  A                Biopsy, skin add-on...       0.41       0.34       0.19        0.02        0.77       0.62        ZZZ
11200............  ..