[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]
[Page 73989-74086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-233]
[[Page 73989]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--July Through September 2007; Notice
[[Page 73990]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9042-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--July Through September 2007
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from July 2007 through September 2007, relating to the
Medicare and Medicaid programs. This notice provides information on
national coverage determinations (NCDs) affecting specific medical and
health care services under Medicare. Additionally, this notice
identifies certain devices with investigational device exemption (IDE)
numbers approved by the Food and Drug Administration (FDA) that
potentially may be covered under Medicare. This notice also includes
listings of all approval numbers from the Office of Management and
Budget for collections of information in CMS regulations and a list of
Medicare-approved carotid stent facilities. Included in this notice is
a list of the American College of Cardiology's National Cardiovascular
Data registry sites, active CMS coverage-related guidance documents,
and special one-time notices regarding national coverage provisions.
Also included in this notice is a list of National Oncologic Positron
Emissions Tomography Registry sites, a list of Medicare-approved
ventricular assist device (destination therapy) facilities, a list of
Medicare-approved lung volume reduction surgery facilities, a list of
Medicare-approved clinical trials for fluorodeoxyglucose positron
emissions tomogrogphy for dementia, and a list of Medicare-approved
bariatric surgery facilities.
Section 1871(c) of the Social Security Act requires that we publish
a list of Medicare issuances in the Federal Register at least every 3
months. Although we are not mandated to do so by statute, for the sake
of completeness of the listing, and to foster more open and transparent
collaboration efforts, we are also including all Medicaid issuances and
Medicare and Medicaid substantive and interpretive regulations
(proposed and final) published during this 3-month time frame.
FOR FURTHER INFORMATION CONTACT: It is possible that an interested
party may need specific information and not be able to determine from
the listed information whether the issuance or regulation would fulfill
that need. Consequently, we are providing contact persons to answer
general questions concerning these items. Copies are not available
through the contact persons. (See Section III of this notice for how to
obtain listed material.)
Questions concerning CMS manual instructions in Addendum III may be
addressed to Timothy Jennings, Office of Strategic Operations and
Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05,
7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-2134.
Questions concerning regulation documents published in the Federal
Register in Addendum IV may be addressed to Gwendolyn Johnson, Office
of Strategic Operations and Regulatory Affairs, Centers for Medicare &
Medicaid Services, C4-14-03, 7500 Security Boulevard, Baltimore, MD
21244-1850, or you can call (410) 786-6954.
Questions concerning Medicare NCDs in Addendum V may be addressed
to Patricia Brocato-Simons, Office of Clinical Standards and Quality,
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.
Questions concerning FDA-approved Category B IDE numbers listed in
Addendum VI may be addressed to John Manlove, Office of Clinical
Standards and Quality, Centers for Medicare & Medicaid Services, C1-13-
04, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-6877.
Questions concerning approval numbers for collections of
information in Addendum VII may be addressed to Melissa Musotto, Office
of Strategic Operations and Regulatory Affairs, Regulations Development
and Issuances Group, Centers for Medicare & Medicaid Services, C5-14-
03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-6962.
Questions concerning Medicare-approved carotid stent facilities in
Addendum VIII may be addressed to Sarah J. McClain, Office of Clinical
Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-2994.
Questions concerning Medicare's recognition of the American College
of Cardiology-National Cardiovascular Data Registry sites in Addendum
IX may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards
and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410)
786-7205.
Questions concerning Medicare's active coverage-related guidance
documents in Addendum X may be addressed to Janet Brock, Office of
Clinical Standards and Quality, Centers for Medicare & Medicaid
Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850,
or you can call (410) 786-2700.
Questions concerning one-time notices regarding national coverage
provisions in Addendum XI may be addressed to Ellie Lund, Office of
Clinical Standards and Quality, Centers for Medicare & Medicaid
Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850,
or you can call (410) 786-2281.
Questions concerning National Oncologic Positron Emission
Tomography Registry sites in Addendum XII may be addressed to Stuart
Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for
Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850, or you can call (410) 786-8564.
Questions concerning Medicare-approved ventricular assist device
(destination therapy) facilities in Addendum XIII may be addressed to
JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850, or you can call (410) 786-7205.
Questions concerning Medicare-approved lung volume reduction
surgery facilities listed in Addendum XIV may be addressed to JoAnna
Baldwin, MS, Office of Clinical Standards and Quality, Centers for
Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850, or you can call (410) 786-7205.
Questions concerning Medicare-approved bariatric surgery facilities
listed in Addendum XV may be addressed to Kate Tillman, RN, MA, Office
of Clinical Standards and Quality, Centers for Medicare & Medicaid
Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850,
or you can call (410) 786-9252.
Questions concerning fluorodeoxyglucose positron emission
[[Page 73991]]
tomography for dementia trials listed in Addendum XVI may be addressed
to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality,
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564.
Questions concerning all other information may be addressed to
Gwendolyn Johnson, Office of Strategic Operations and Regulatory
Affairs, Regulations Development Group, Centers for Medicare & Medicaid
Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850,
or you can call (410) 786-6954.
SUPPLEMENTARY INFORMATION:
I. Program Issuances
The Centers for Medicare & Medicaid Services (CMS) is responsible
for administering the Medicare and Medicaid programs. These programs
pay for health care and related services for 39 million Medicare
beneficiaries and 35 million Medicaid recipients. Administration of the
two programs involves (1) furnishing information to Medicare
beneficiaries and Medicaid recipients, health care providers, and the
public and (2) maintaining effective communications with regional
offices, State governments, State Medicaid agencies, State survey
agencies, various providers of health care, all Medicare contractors
that process claims and pay bills, and others. To implement the various
statutes on which the programs are based, we issue regulations under
the authority granted to the Secretary of the Department of Health and
Human Services under sections 1102, 1871, 1902, and related provisions
of the Social Security Act (the Act). We also issue various manuals,
memoranda, and statements necessary to administer the programs
efficiently.
Section 1871(c)(1) of the Act requires that we publish a list of
all Medicare manual instructions, interpretive rules, statements of
policy, and guidelines of general applicability not issued as
regulations at least every 3 months in the Federal Register. We
published our first notice June 9, 1988 (53 FR 21730). Although we are
not mandated to do so by statute, for the sake of completeness of the
listing of operational and policy statements, and to foster more open
and transparent collaboration, we are continuing our practice of
including Medicare substantive and interpretive regulations (proposed
and final) published during the respective 3-month time frame.
II. How To Use the Addenda
This notice is organized so that a reader may review the subjects
of manual issuances, memoranda, substantive and interpretive
regulations, NCDs, and FDA-approved IDEs published during the subject
quarter to determine whether any are of particular interest. We expect
this notice to be used in concert with previously published notices.
Those unfamiliar with a description of our Medicare manuals may wish to
review Table I of our first three notices (53 FR 21730, 53 FR 36891,
and 53 FR 50577) published in 1988, and the notice published March 31,
1993 (58 FR 16837). Those desiring information on the Medicare NCD
Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may
wish to review the August 21, 1989, publication (54 FR 34555). Those
interested in the revised process used in making NCDs under the
Medicare program may review the September 26, 2003, publication (68 FR
55634).
To aid the reader, we have organized and divided this current
listing into 11 addenda:
Addendum I lists the publication dates of the most recent
quarterly listings of program issuances.
Addendum II identifies previous Federal Register documents
that contain a description of all previously published CMS Medicare and
Medicaid manuals and memoranda.
Addendum III lists a unique CMS transmittal number for
each instruction in our manuals or Program Memoranda and its subject
matter. A transmittal may consist of a single or multiple
instruction(s). Often, it is necessary to use information in a
transmittal in conjunction with information currently in the manuals.
Addendum IV lists all substantive and interpretive
Medicare and Medicaid regulations and general notices published in the
Federal Register during the quarter covered by this notice. For each
item, we list the--
[cir] Date published;
[cir] Federal Register citation;
[cir] Parts of the Code of Federal Regulations (CFR) that have
changed (if applicable);
[cir] Agency file code number; and
[cir] Title of the regulation.
Addendum V includes completed NCDs, or reconsiderations of
completed NCDs, from the quarter covered by this notice. Completed
decisions are identified by the section of the NCDM in which the
decision appears, the title, the date the publication was issued, and
the effective date of the decision.
Addendum VI includes listings of the FDA-approved IDE
categorizations, using the IDE numbers the FDA assigns. The listings
are organized according to the categories to which the device numbers
are assigned (that is, Category A or Category B), and identified by the
IDE number.
Addendum VII includes listings of all approval numbers
from the Office of Management and Budget (OMB) for collections of
information in CMS regulations in title 42; title 45, subchapter C; and
title 20 of the CFR.
Addendum VIII includes listings of Medicare-approved
carotid stent facilities. All facilities listed meet CMS standards for
performing carotid artery stenting for high risk patients.
Addendum IX includes a list of the American College of
Cardiology's National Cardiovascular Data registry sites. We cover
implantable cardioverter defibrillators (ICDs) for certain indications,
as long as information about the procedures is reported to a central
registry.
Addendum X includes a list of active CMS guidance
documents. As required by section 731 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-
173, enacted on December 8, 2003), we will begin listing the current
versions of our guidance documents in each quarterly listings notice.
Addendum XI includes a list of special one-time notices
regarding national coverage provisions. We are publishing a list of
issues that require public notification, such as a particular clinical
trial or research study that qualifies for Medicare coverage.
Addendum XII includes a listing of National Oncologic
Positron Emission Tomography Registry (NOPR) sites. We cover positron
emission tomography (PET) scans for particular oncologic indications
when they are performed in a facility that participates in the NOPR.
Addendum XIII includes a listing of Medicare-approved
facitilites that receive coverage for ventricular assist devices used
as destination therapy. All facilities were required to meet our
standards in order to receive coverage for ventricular assist devices
implanted as destination therapy.
Addendum XIV includes a listing of Medicare-approved
facilities that are eligible to receive coverage for lung volume
reduction surgery. Until May 17, 2007, facilities that participated in
the National Emphysema Treatment Trial are also eligible to receive
coverage.
Addendum XV includes a listing of Medicare-approved
facilities that meet minimum standards for facilities modeled in part
on professional society statements on competency. All facilities
[[Page 73992]]
must meet our standards in order to receive coverage for bariatric
surgery procedures.
Addendum XVI includes a listing of Medicare-approved
clinical trials for fluorodeoxyglucose positron emission tomography
(FDG-PET) for dementia and neurodegenerative diseases.
III. How To Obtain Listed Material
A. Manuals
Those wishing to subscribe to program manuals should contact either
the Government Printing Office (GPO) or the National Technical
Information Service (NTIS) at the following addresses:
Superintendent of Documents, Government Printing Office, ATTN: New
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202)
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda
listed in this notice can be purchased from NTIS. Interested parties
should identify the transmittal(s) they want. GPO or NTIS can give
complete details on how to obtain the publications they sell.
Additionally, most manuals are available at the following Internet
address: http://cms.hhs.gov/manuals/default.asp.
B. Regulations and Notices
Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an
online database through GPO Access. The online database is updated by 6
a.m. each day the Federal Register is published. The database includes
both text and graphics from Volume 59, Number 1 (January 2, 1994)
forward. Free public access is available on a Wide Area Information
Server (WAIS) through the Internet and via asynchronous dial-in.
Internet users can access the database by using the World Wide Web; the
Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html
, by using local WAIS client software,
or by telnet to swais.gpoaccess.gov, then log in as guest (no password
required). Dial-in users should use communications software and modem
to call (202) 512-1661; type swais, then log in as guest (no password
required).
C. Rulings
We publish rulings on an infrequent basis. CMS Rulings are
decisions of the Administrator that serve as precedent final opinions
and orders and statements of policy and interpretation. They provide
clarification and interpretation of complex or ambiguous provisions of
the law or regulations relating to Medicare, Medicaid, Utilization and
Quality Control Peer Review, private health insurance, and related
matters. Interested individuals can obtain copies from the nearest CMS
Regional Office or review them at the nearest regional depository
library. We have, on occasion, published rulings in the Federal
Register. Rulings, beginning with those released in 1995, are available
online, through the CMS Home Page. The Internet address is http://cms.hhs.gov/rulings
.
D. CMS' Compact Disk--Read Only Memory (CD-ROM)
Our laws, regulations, and manuals are also available on CD-ROM and
may be purchased from GPO or NTIS on a subscription or single copy
basis. The Superintendent of Documents list ID is HCLRM, and the stock
number is 717-139-00000-3. The following material is on the CD-ROM
disk:
Titles XI, XVIII, and XIX of the Act.
CMS-related regulations.
CMS manuals and monthly revisions.
CMS program memoranda.
The titles of the Compilation of the Social Security Laws are
current as of January 1, 2005. (Updated titles of the Social Security
Laws are available on the Internet at http://www.ssa.gov/OP_Home/ssact/comp-toc.htm.
) The remaining portions of CD-ROM are updated on a
monthly basis.
Because of complaints about the unreadability of the Appendices
(Interpretive Guidelines) in the State Operations Manual (SOM), as of
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future and, with the aid of newer
technology, we may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the
reports once the files have been copied to a personal computer disk.
IV. How To Review Listed Material
Transmittals or Program Memoranda can be reviewed at a local
Federal Depository Library (FDL). Under the FDL program, government
publications are sent to approximately 1,400 designated libraries
throughout the United States. Some FDLs may have arrangements to
transfer material to a local library not designated as an FDL. Contact
any library to locate the nearest FDL.
In addition, individuals may contact regional depository libraries
that receive and retain at least one copy of most Federal Government
publications, either in printed or microfilm form, for use by the
general public. These libraries provide reference services and
interlibrary loans; however, they are not sales outlets. Individuals
may obtain information about the location of the nearest regional
depository library from any library.
For each CMS publication listed in Addendum III, CMS publication
and transmittal numbers are shown. To help FDLs locate the materials,
use the CMS publication and transmittal numbers. For example, to find
the Medicare Benefit Policy publication titled ``Ultrasound Diagnostic
Procedures,'' use CMS-Pub. 100-03, Transmittal No. 72.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: December 10, 2007.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listings of program issuances.
September 23, 2005 (70 FR 55863)
December 23, 2005 (70 FR 76290)
March 24, 2006 (71 FR 14903)
June 23, 2006 (71 FR 36101)
September 29, 2006 (71 FR 57604)
December 22, 2006 (71 FR 77202)
March 30, 2007 (72 FR 15282)
June 22, 2007 (72 FR 34508)
September 28, 2007 (72 FR 55282)
Addendum II--Description of Manuals, Memoranda, and CMS Rulings
An extensive descriptive listing of Medicare manuals and memoranda
was published on June 9, 1988, at 53 FR 21730 and supplemented on
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR
50577. Also, a complete description of the former CIM (now the NCDM)
was published on
[[Page 73993]]
August 21, 1989, at 54 FR 34555. A brief description of the various
Medicaid manuals and memoranda that we maintain was published on
October 16, 1992, at 57 FR 47468.
Addendum III--Medicare and Medicaid Manual Instructions July Through
September 2007
------------------------------------------------------------------------
Transmittal No. Manual/Subject/Publication Number
------------------------------------------------------------------------
Medicare General Information (CMS-Pub. 100-01)
------------------------------------------------------------------------
45.............................. Cancellation of Data File Extract in
CR 3801.
46.............................. Implement New Contractor ID for Single
Testing Contractor; Standard System
Testing Requirements for Maintainers,
Beta Testers, and Contractors.
47.............................. Revision to Certification for Hospital
Services Covered by the Supplementary
Medical Insurance Program as it
Pertains to Ambulance Services.
Certification for Hospital Services
Covered by the Supplementary Medical
Insurance Program.
------------------------------------------------------------------------
Medicare Benefit Policy (CMS-Pub. 100-02)
------------------------------------------------------------------------
75.............................. Nurse Practitioner Services and
Clinical Nurse Specialist Services
Qualifications for NPs;
Qualifications for CNSs.
76.............................. This Transmittal is rescinded and
replaced by Transmittal 77.
77.............................. Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
78.............................. Unlabeled Use for Anti-Cancer Drugs:
Medical Literature Used to Determine
Medically Accepted Indications for
Drugs and Biologicals Used in Anti-
Cancer Treatment; Unlabeled Use for
Anti-Cancer Drugs.
------------------------------------------------------------------------
Medicare National Coverage Determination (CMS-Pub. 100-03)
------------------------------------------------------------------------
72.............................. Ultrasound Diagnostic Procedures.
73.............................. This Transmittal is rescinded and
replaced by Transmittal 76.
74.............................. Medicare Clinical Trial Policy;
Routine Costs in Clinical Trials
(Effective July 9, 2007).
75.............................. Lumbar Artificial Disc Replacement.
76.............................. Ultrasound Diagnostic Procedure.
77.............................. Percutaneous Transluminal Angioplasty.
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Medicare Claims Processing (CMS-Pub. 100-04)
------------------------------------------------------------------------
1281............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
1282............................ Medicare Contractors Use of the
Coordination of Benefits Agreement
Problem Inquiry Request Form To
Identify and Send Coordination of
Benefits Agreement Related Issues to
the Coordination of Benefits
Contractor Consolidation of the
Claims Crossover Process.
1283............................ National Provider Identifier Required
to Enroll in Electronic Data
Interchange; Update of
Telecommunication and Transmission
Protocols for Electronic Data;
Interchange and Deletion of Obsolete
Reference to Medicaid Subrogation
Claims; Electronic Data Interchange
Enrollment; New Enrollments and
Maintenance of Existing Enrollments;
Telecommunication and Transmission
Protocols.
1284............................ Chapter 24 Update and EFT Format
Standardization Electronic Funds
Transfer; Identification of Those
Providers to be Reviewed.
1285............................ Renal Dialysis Facility Line Item
Billing Requirement for Epoetin Alfa
Submitted on End-Stage Renal Disease
Claims; Required Information for In-
Facility Claims Paid Under the
Composite Rate; Epoetin Alfa Facility
Billing Requirements; Payment Amount
for Epoetin Alfa; Self Administered
EPO Supply; Darbepoetin Alfa
(Aranesp) Facility Billing
Requirements.
1286............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1287............................ Instructions for Downloading the
Medicare ZIP Code Files--January
2008.
1288............................ Update to the Place of Service Code
Set To Add a Code for Prison/
Correctional Facility--VMS Only.
1289............................ Additional Common Working File Editing
for Skilled Nursing Facility
Consolidated Billing; A/B Crossover
Edits; Edit for Ambulance Services;
Edit for Clinical Social Workers.
1290............................ Clarification of Skilled Nursing
Facility Billing Requirements for
Beneficiaries Enrolled in Medicare
Advantage Plans; Medicare Billing
Requirements for Beneficiaries
Enrolled in Medicare Advantage Plans.
1291............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1292............................ Payment for Hospice Care Based on
Location Where Care is Furnished.
1293............................ This Transmittal is rescinded and will
not be replaced at this time.
1294............................ Revision of the Fiscal Intermediary
Standard System to Forward Payment
Ambulatory Payment Classification to
the Common Working File.
1295............................ Laboratory and Radiology: Adjustment
to Common Working File Duplicate
Claim Edit for the Technical
Component of Radiology and Pathology
Laboratory Services Provided to
Hospital Patients.
1296............................ Modifications to the National
Coordination of Benefits Agreement
Crossover Process; Consolidated
Claims Crossover Process;
Consolidation of the Claims Crossover
Process; Coordination of Benefits
Agreement Detailed Error Report
Notification Process; Coordination of
Benefits Agreement Full Claim File
Repair Process.
1297............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
1298............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction 1299
Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction 1300
Healthcare Provider Taxonomy Codes
Update October 2007
1301............................ Revised Information on Positron
Emission Tomography Scan Coding;
Appropriate CPT Codes Effective for
Positron Emission Tomography Scans
for Services Performed on or After
January 28, 2005; Tracer Codes
Required for Positron Emission
Tomography Scans; Medicare Summary
Notice; Remittance Advice Message.
1302............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1303............................ Modification of Part B Flat File for
Electronic Remittance Advice--
Transaction 835.
[[Page 73994]]
1304............................ Reporting of Additional Data to
Describe Services on Hospice Claims;
Levels of Care; Data Required on
Claim to Fiscal Intermediary.
1305............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1306............................ Medicare Part A Skilled Nursing
Facility Prospective Payment System
Pricer Update for FY 2008.
1307............................ Modification to the National
Monitoring Policy for Erythropoietic
Stimulating Agents for End-Stage
Renal Disease Patients Treated in
Renal Dialysis Facilities; Epoetin
Alfa; Darbepoetin Alfa (Aranesp) for
End-Stage Renal Disease patients.
1308............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
1309............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1310............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1311............................ Capturing Days on Which Medicare
Beneficiaries are Entitled to
Medicare; Advantage in the Medicare/
Supplemental Security Income
Fraction; Additional Payment Amounts
for Hospitals with Disproportionate
Share of Low-Income Patients; Low
Income Patient Adjustment: The
Supplemental Security; Income/
Medicare Beneficiary Data for
Inpatient Rehabilitation Facilities
Paid Under the Prospective Payment
System.
1312............................ Timeliness Standards for Processing
Other-Than-Clean Claims.
1313............................ Response to Competitive Acquisition
for Part B Drugs and Biologicals
Claims When the Common Working File
69XD Error Code is Received;
Submission of Claims With the
Modifier JW, ``Drug Amount Discarded/
Not Administered to Any Patient''.
1314............................ Claim Status Category Code and Claim
Status Code Update.
1315............................ Clarification of Percutaneous
Transluminal Angioplasty Billing
Requirements Issued in CR 3811;
Carotid Artery Stenting With Embolic
Protection Coverage.
1316............................ This Transmittal is rescinded and
replaced by Transmittal 1324.
1317............................ 2008 Annual Update of Healthcare
Common Procedure Coding System Codes
for Skilled Nursing Facility;
Consolidated Billing for the Common
Working File Medicare Carriers and
Fiscal Intermediaries.
1318............................ This Transmittal is rescinded and
replaced by Transmittal 1333.
1319............................ Date of Service for Laboratory
Specimens.
1320............................ 2008 Annual Update for the Health
Professional Shortage Area Bonus
Payment.
1321............................ Sunset of the Physician Scarcity Bonus
Payment; Billing and Payment in a
Physician Scarcity Area; Zip Code
Files; Physician Rendering Anesthesia
in a Hospital Outpatient Setting;
Billing and Payment in a Physician
Scarcity Area.
1322............................ Indian Health Service Hospital Payment
Rates for Calendar Year 2007.
1323............................ Inpatient Rehabilitation Facility
Annual Update: Prospective Payment
System Pricer Changes for FY 2008.
1324............................ Anesthesia Services Furnished by the
Same Physician Providing the Medical
and Surgical Service; General Payment
for Anesthesiology Services.
1325............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
1326............................ Update to the 2007 Medicare Physician
Fee Schedule Database.
1327............................ Schedule for Completing the Calendar
Year (CY) 2008 Fee Schedule Updates
and the Participating Physician
Enrollment Process--(For
Informational Purposes Only).
1328............................ Delete References to Reporting of the
National Provider Identifier on or
after May 23, 2007, and Revise
References to a ``When Required''
Date Carrier Data Element
Requirements; Conditional Data
Element Requirements for Carriers and
DMERCs; Carrier Specific Requirements
for Certain Specialties/Services.
1329............................ Modification to the Timeliness
Requirements for Contractors
Forwarding Reconsideration Requests
Submitted to the Wrong Contractor
Filing a Request for a
Reconsideration.
1330............................ Quarterly Update to Correct Coding
Initiative Edits, Version 13.3,
Effective October 1, 2007.
1331............................ Issued to a specific audience. Not
posted to Internet/Intranet due to
Confidentiality of Instruction.
1332............................ Transitioning the Mandatory Medigap
(``Claim-Based'') Crossover Process
to the Coordination of Benefits
Contractor; Claims Crossover
Disposition Indicators; Coordination
of Benefits Agreement (COBA) Medigap
Claim-Based Crossover Process;
Completion of the Claim Form; Form
CMS-1500 (ANSI X12N 837 Coordination
of Benefits (version 4010)).
1333............................ Ambulance: New Remark Code for Denying
Separately Billed Services General
Coverage and Payment Policies.
1334............................ October 2007 Quarterly Average Sales
Price (ASP) Medicare Part B Drug
Pricing Files and Revisions to Prior
Quarterly Pricing Files.
1335............................ Updating the Internet Only Manual to
Include Language or National
Provider; Identifier When Required;
Payment Under Reciprocal Billing
Arrangements--Claims Submitted to
Carriers; Physicians Payment Under
Locum Tenens Arrangements--Claims
Submitted to Carriers; Billing
Procedures for Entities Qualified To
Receive Payment on Basis of
Reassignment--for Carrier Processed
Claims; Billing Procedures for
Entities Qualified To Receive Payment
on Basis of Reassignment--for Carrier
Processed Claims; Carrier
Participation and Billing
Limitations.
1336............................ October 2007 Update of the Hospital
Outpatient Prospective Payment
System; Summary of Payment Policy
Changes; Billing for Devices Eligible
for Transitional Pass-Through
Payments and Items Classified in
``New Technology'' APCs; Categories
for Use in Coding Devices Eligible
for Transitional Pass-Through
Payments Under the Hospital OPPS;
Roles of Hospitals, Manufacturers,
and CMS in Billing for Transitional
Pass-Through Items; Devices Eligible
for Transitional Pass-Through
Payments; General Coding and Billing
Instructions and Explanations;
Services Eligible for New Technology
Ambulatory Payment Class Assignment
and Payments.
1337............................ Revisions to 9-Digit ZIP Code List
Provided in Change Request 5208.
1338............................ Issued to a specific audience, not
posted to Internet/Intranet due to
Sensitivity of Instruction.
1339............................ Magnetic Resonance Imaging Procedures.
1340............................ Lumbar Artificial Disc Replacement;
General; Carrier Billing
Requirements; Fiscal Billing
Requirements; Reasons for Denial and
Medicare Summary Notice Claim
Adjustment Reason; Code Messages and
Remittance Advice Remark Code;
Advanced Beneficiary Notice and
Hospital Issued Notice of Noncoverage
Information.
1341............................ New Web Site for Approved Transplant
Centers; Billing Transplant Services;
Kidney Transplants--General; Billing
for Kidney Transplants and
Acquisition Services; Heart
Transplants; Liver Transplants;
Billing for Liver Transplants and
Acquisition Services; Pancreas
Transplants Kidney Transplants;
Pancreas Transplant Alone; Intestinal
and Multi-Visceral Transplants; Renal
Transplantation and Related Services.
1342............................ October 2007 Integrated Outpatient
Code Editor (I/OCE) Specifications
Version 8.3.
[[Page 73995]]
1343............................ Stage 3 NPI Changes for Transaction
835 and Standard Paper Remittance;
Advice; Background; Remittance
Balancing; Medicare Standard
Electronic PC Print Software for
Institutional Providers; Part A (A/B
Macs/FIs/RHHIs) SPR Format; Part B (A/
B Mac/Carrier/DMERC/DME MAC) SPR
Format; Part A (A/B MAC/FI/RHHI) SPR
Crosswalk to the 835; 22/50/50.4/Part
B (A/B Mac/Carrier/DMERC/DME MAC) SPR
Crosswalk to the 835.
1344............................ Reasonable Charge Update for 2008 for
Splints, Casts, Dialysis Supplies,
Dialysis Equipment, and Certain
Intraocular Lenses.
1345............................ Remittance Advice Remark Code and
Claim Adjustment Reason Code Update.
1346............................ New Waived Tests.
1347............................ MSN Message: Revised 38.13; General
Information; Seccion De Informacion
General.
------------------------------------------------------------------------
Medicare Secondary Payer (CMS-Pub. 100-05)
------------------------------------------------------------------------
00.............................. None.
------------------------------------------------------------------------
Medicare Financial Management (CMS-Pub. 100-06)
------------------------------------------------------------------------
126............................ Manual Revision Re: Medicare Summary
Notice Workload Reporting; Body of
Report; Part C--Miscellaneous Claims
Data.
127............................. Instructions for Documenting Scoping
Decision of Provider's Internal
Controls; Revisions to Continuing
Education and Training and Revision
Regarding Time Frame for Settling
Cost Reports; Tests of Internal
Control; Qualifications; Final
Settlement of the Cost Report.
128............................. Revisions to Instructions On Chapter
1--Budget Preparation--Intermediaries
and Carriers and Chapter 2--Budget
Execution of the Medicare Financial
Management (CMS Pub. 100-06); List of
Acronyms; Budget Preparation Check
List for Program Management and
Medicare Integrity Program;
Instructions for Using the System for
Tracking Audit and Reimbursement
Servicing Contractor; Transmittal and
Due Dates; Exhibit of Variances
Analysis; Variance Analysis;
Transmittal and Due Dates; Budget
Execution Checklist for Program
Management and Medicare Integrity
Program.
129............................. Notice of New Interest Rate for
Medicare Overpayments and
Underpayments--4th Quarter FY 2007.
130............................. Revisions of the CROWD Report; Monthly
Statistical Report on Intermediary
and Carrier Part A and Part B Appeals
Activity Form (CMS-2592); General;
Section I--Redeterminations; Section
II--Qualified Independent Contractor
Reconsiderations; Section III--
Administrative Law Judge Results;
Section IV--Medicare Appeals Council
Effectuations; Clerical Error
Reopenings; Validation of Reports.
131............................. Participating Physicians Report--
Deletion of Requirement to Forward a
Memorandum to CMS Detailing
Adjustments to Form F Column 1 (PAR
Prior) (from previous enrollment
period).
------------------------------------------------------------------------
Medicare State Operations Manual (CMS-Pub. 100-07)
------------------------------------------------------------------------
26............................. Revised Appendix P and Appendix PP--
New Tag F373.
27.............................. Revisions to Appendix PP--Guidance to
Surveyors for Long Term Care
Facilities.
28.............................. Revisions to Appendix D--Guidance to
Surveyors for Portable X-ray.
------------------------------------------------------------------------
Medicare Program Integrity (CMS-Pub. 100-08)
------------------------------------------------------------------------
215............................. Implementation of Durable Medical
Equipment Medicare Administrative
Contractor Access to Viable
Information Processing Systems
Medicare Shared System; Medical
Review Functions at DME MACs.
216............................. Implementation of New Compliance
Standards for Independent Diagnostic
Testing Facilities; Independent
Diagnostic Testing Facility
Attachment; Independent Diagnostic
Testing Facility Standards; Multi-
State Independent Diagnostic Testing
Facility Entities; Interpreting
Physician; Technicians; Supervising
Physicians; Desk and Site Reviews;
Special Procedures and Supplier
Types.
217............................. Provider Enrollment Fraud Detection
Program for High Risk Areas;
Submission of Proposed Implementation
Plan for High Risk Areas.
218............................. Provider Enrollment Manual Update;
Introduction to Provider Enrollment;
Definitions; CMS-855 Medicare
Enrollment Applications; Timeframes
for Initial Applications; Timeframes
for Changes of Information; General
Timeliness Principles; Returning the
Application; Basic Information
(Section 1 of the CMS-855); Employer
Identification Numbers and Legal
Business Names; Licenses and
Certifications; Correspondence
Address; Accreditation; Section 2 of
the CMS-855A; Section 2 of the CMS-
855B; Section 2 of the CMS-855I;
Adverse Legal Actions/Convictions;
Practice Location Information;
Section 4 of the CMS-855A; Section 4
of the CMS-855B; Section 4 of the CMS-
855I; Contact Person; Home Health
Agencies; Provider Enrollment
Inquiries.
219............................. Nurse Practitioner Services and
Clinical Nurse Specialist Services.
220............................. Various Medical Review Clarifications;
Annual MR Strategy; Verifying
Potential Error and Setting
Priorities; Overview of Prepayment
and Postpayment Review for Medical
Review Purposes; Documentation
Specifications for Areas Selected for
Prepayment or Postpayment Medical
Review; Medical Review Denial
Notices; Automated Prepayment
Review;Postpayment Review of Claims
for Medical Review Purposes; Provider
Notification and Feedback; Provider
Types and Subtypes; Medicare
Integrity Program CERT (Activity Code
21901).
221............................. Administrative Appeals for Provider
Enrollment Administrative Appeals.
222............................. Discontinuance of the Unique Physician
Identification Number Registry.
------------------------------------------------------------------------
[[Page 73996]]
Provider Notification and Feedback Medicare Contractor Beneficiary and
Provider Communications (CMS-Pub. 100-09)
------------------------------------------------------------------------
20.............................. Institute Of Medicine Pub. 100-09,
Chapter 3--Provider Inquiries and
Chapter 6--Provider Customer Service
Program Updates; Availability of
Telephone Services; Automated
Services--Interactive Voice Response;
Toll Free Network Services;
Publication of Toll Free Numbers;
Call Handling Requirements; Customer
Service Assessment and Management
System Reporting Requirements; CSR
Qualifications; Staff Development and
Training; Fraud and Abuse;
Performance Improvements Provider
Contact Center User Group;
Performance Improvements; Contractor
Guidelines for High Quality Responses
to Telephone Inquiries; Quality Call
Monitoring Program; Quality Call
Monitoring Calibration; Quality Call
Monitoring Performance Standards;
Written Inquiries; Contractor
Guidelines for High Quality Responses
to Written Inquiries; Quality Written
Correspondence Monitoring Program;
Quality Written Correspondence
Monitoring Calibration; Quality
Written Correspondence Monitoring
Performance Standards; Walk-In
Inquiries; Guidelines for High
Quality Walk-In Service; Surveys;
Customer Service Operations Surveys;
Provider Satisfaction Surveys;
Contractor Activities Related to the
Medicare Provider Satisfaction
Survey; Provider Inquiry Reporting
Standardization; Provider Transaction
Access Number; Inquiry
Types;Telephone Inquiries; Contractor
Discretion Concerning Interactive
Voice Response Information; Written
Inquiries; Special Inquiry Topics;
Overlapping Claims; Pending Claims;
Requests for Information Available on
the Interactive Voice Response;
Requests for Information Available on
the Remittance Advice Notice;
Deceased Beneficiaries; Disclosure
Desk Reference for Provider Contact
Centers; Authentication of Provider
Elements for Customer Service
Representative Inquiries;
Authentication of Provider Elements
for Interactive Voice Response
Inquiries; Authentication of Provider
Elements for Written Inquiries;
Authentication of Beneficiary
Elements; POE Goals; Error Rate
Reduction Data; Error Rate Reduction
Plan; Refunds/Credits for
Cancellation of Events; Availability
Requirements; Quality Call Monitoring
Program; Telephone Responses; Quality
Written Correspondence Monitoring
Program; Complex Beneficiary
Inquiries; Interactive Voice Response
System; Call Completion; Average
Speed of Answer; Quality Call
Monitoring Performance Standards;
Quality Written Correspondence
Monitoring Performance Standards;
General Inquiries Timeliness;
Customer Service Assessment and
Management System Reporting
Requirements; Provider Transaction
Access Number; Inquiry Types;
Telephone Inquiries; Contractor
Discretion Concerning Interactive
Voice Response Information; Written
Inquiries; Special Inquiry Topics;
Pending Claims; Requests for
Information Available on the
Interactive Voice Response; Requests
for Information Available on the
Remittance Advice Notice; Deceased
Beneficiaries; Disclosure Desk
Reference for Provider Contact
Centers; Authentication of Provider
Elements for Interactive Voice
Response Inquiries; Authentication of
Provider Elements for Written
Inquiries; Authentication of
Beneficiary Elements; Inquiry
Standardized Categories.
------------------------------------------------------------------------
Medicare Managed Care (CMS-Pub. 100-16)
------------------------------------------------------------------------
88.............................. Revisions to Chapter 13, ``Medicare
Managed Care Beneficiary Grievances,
Organization Determinations, and
Appeals Applicable to Medicare
Advantage Plans, Cost Plans, and
Health Care Prepayment Plans
(collectively referred to as Medicare
Health Plans)''; Definition of Terms/
Grievance; Responsibilities of the
Medicare Health Plan; Procedures for
Handling a Grievance; Organization
Determinations; Written Notification
by Medicare Health Plan of Its Own
Decision; Representatives Filing
Appeals for Enrollees; Authority of a
Representative; Notice Delivery to
Representatives; How the Medicare
Health Plan Processes Requests for
Expedited Reconsiderations;
Forwarding Adverse Reconsiderations
to the Independent Review Entity; QIO
Expedited Reviews of Coverage
Terminations in Certain Provider
Settings (SNF, HHA, and CORF); Notice
of Medicare Non-Coverage; Meaning of
Valid Delivery; Authority of a QIO to
Request Enrollee Records;
Determination of Amount in
Controversy; Judicial Review;
Requesting Immediate Quality
Improvement Organization Review of
Inpatient Hospital Care; Data;
Reporting Unit for Appeal and
Grievance Data Collection
Requirements; Data Collection and
Reporting Periods; New Reporting
Periods Start Every 6 Months;
Maintaining Data; Appeal and
Grievance Data Collection
Requirements; Quality of Care
Grievance Data; Beneficiary Appeals
and Quality of Care Grievances
Explanatory Data Report.
------------------------------------------------------------------------
Medicare Business Partners Systems Security (CMS-Pub. 100-17)
------------------------------------------------------------------------
00.............................. None.
------------------------------------------------------------------------
Demonstrations (CMS-Pub. 100-19)
------------------------------------------------------------------------
00.............................. None.
------------------------------------------------------------------------
One Time Notification (CMS-Pub. 100-20)
------------------------------------------------------------------------
287............................. Fiscal Intermediary Standard System
Recoupment and Claims Adjustment;
Process Changes--Limitation of
Recoupment--Analysis and Design.
288............................. Creating a New File Transaction Layout
Utilizing Automated Response Units.
289............................. Present on Admission Indicator Systems
Implementation.
290............................. New Contractor Number for Trispan
Missouri Part A Workload.
291............................. Cessation of FI-to-FI Moves for
Providers that are Members of Chains.
292............................. Issued to specific audience, not
posted to Internet/Intranet due to
Confidentiality of Instruction.
------------------------------------------------------------------------
[[Page 73997]]
Addendum IV--Regulation Documents Published in the Federal Register July Through September 2007
----------------------------------------------------------------------------------------------------------------
FR volume
Publication date 72 page 42 CFR parts affected File code Title of
number regulation
----------------------------------------------------------------------------------------------------------------
July 5, 2007.............. 36710 .......................... CMS-5042-N2.............. Medicare
Program;
Solicitation
for Proposals
From Rural
Hospitals to
Participate in
the Medicare
Hospital
Gainsharing
Demonstration
Program Under
Section 5007 of
the Deficit
Reduction Act.
July 5, 2007.............. 36613 412 and 413............... CMS-1529-CN.............. Medicare
Program;
Prospective
Payment System
for Long-Term
Care Hospitals
RY 2008: Annual
Payment Rate
Updates, and
Policy Changes;
Corrections.
July 5, 2007.............. 36612 412 and 413............... CMS-1529-N............... Medicare
Program;
Hospital Direct
and Indirect
Graduate
Medical
Education
Policy Changes;
Notice.
July 12, 2007............. 38122 409, 410, 411, 413, 414, CMS-1385-P............... Medicare
415, 418, 423, 424, 484, Program;
485, and 491. Proposed
Revisions to
Payment
Policies Under
the Physician
Fee Schedule,
and Other Part
B Payment
Policies for CY
2008; Proposed
Revisions to
the Payment
Policies of
Ambulance
Services Under
the Ambulance
Fee Schedule
for CY 2008;
and the
Proposed
Elimination of
the E-
Prescribing
Exemption for
Computer-
Generated
Facsimile
Transmissions.
July 13, 2007............. 38662 435, 436, 440, 441, 457, CMS-2257-F............... Medicaid
and 483. Program;
Citizenship
Documentation
Requirements.
July 17, 2007............. 39142 447....................... CMS-2238-FC.............. Medicaid
Program;
Prescription
Drugs.
July 20, 2007............. 39776 455....................... CMS-2264-P............... Medicaid
Integrity
Program;
Limitation on
Contractor
Liability.
July 20, 2007............. 39746 402....................... CMS-6146-F, Medicare
CMS-6019-F.............. Program;
Revised Civil
Money
Penalties,
Assessments,
Exclusions, and
Related Appeals
Procedures.
July 27, 2007............. 41333 .......................... CMS-1388-N............... Medicare
Program;
Request for
Nominations and
Meeting of the
Practicing
Physicians
Advisory
Council, August
27, 2007.
July 27, 2007............. 41331 .......................... CMS-2272-PN.............. Medicare and
Medicaid
Programs;
Application by
the American
Osteopathic
Association
(AOA) for
Continued
Deeming
Authority for
Critical Access
Hospitals
(CAHs).
July 27, 2007............. 41232 148....................... CMS-2260-IFC............. High Risk Pools.
July 27, 2007............. 41230 146....................... CMS-4094-F5.............. Amendment to the
Interim Final
Regulation for
Mental Health
Parity.
August 1, 2007............ 42001 424....................... CMS-6006-P............... Medicare
Program; Surety
Bond
Requirement for
Suppliers of
Durable Medical
Equipment,
Prosthetics,
Orthotics, and
Supplies
(DMEPOS).
August 2, 2007............ 42628 410, 411, 414, 416, 419, CMS-1392-P............... Medicare
482, and 485. Program;
Proposed
Changes to the
Hospital
Outpatient
Prospective
Payment System
and CY 2008
Payment Rates;
Proposed
Changes to the
Ambulatory
Surgical Center
Payment System
and CY 2008
Payment Rates;
Medicare and
Medicaid
Programs;
Proposed
Changes to
Hospital
Conditions of
Participation;
Proposed
Changes
Affecting
Necessary
Provider
Designations of
Critical Access
Hospitals.
August 2, 2007............ 42470 410 and 416............... CMS-1517-F............... Medicare
Program;
Revised Payment
System Policies
and Services
Furnished in
Ambulatory
Surgical
Centers (ASCs)
Beginning in CY
2008.
August 3, 2007............ 43412 409....................... CMS-1545-F............... Medicare
Program;
Prospective
Payment System
and
Consolidated
Billing for
Skilled Nursing
Facilities for
FY 2008.
August 6, 2007............ 43581 409, 410, 411, 413, 414, CMS-1385-CN.............. Medicare
415, 418, 423, 424, 484, Program;
485, and 491. Proposed
Revisions to
Payment
Policies Under
the Physician
Fee Schedule,
and Other Part
B Payment
Policies for CY
2008; Proposed
Revisions to
the Payment
Policies of
Ambulance
Services Under
the Ambulance
Fee Schedule
for CY 2008;
and the
Proposed
Elimination of
the E-
Prescribing
Exemption for
Computer-
Generated
Facsimile
Transmissions;
Corrections.
August 7, 2007............ 44284 412....................... CMS-1551-F............... Medicare
Program;
Inpatient
Rehabilitation
Facility
Prospective
Payment System
for Federal
Fiscal Year
2008.
August 7, 2007............ 44150 .......................... CMS-3188-NC.............. Medicare
Program;
Evaluation
Criteria and
Standards for
Quality
Improvement
Program
Organization
Contracts.
August 13, 2007........... 45201 440 and 441............... CMS-2261-P............... Medicaid
Program;
Coverage for
Rehabilitative
Services.
August 17, 2007........... 46175 402....................... CMS-6146-CN2, Medicare
CMS-6019-CN............. Program;
Revised Civil
Money
Penalties,
Assessments,
Exclusions, and
Related Appeals
Procedures;
Correction.
August 22, 2007........... 47130 411,412, 413, and 489..... CMS-1533-FC.............. Medicare
Program;
Changes to the
Hospital
Inpatient
Prospective
Payment Systems
and Fiscal Year
2008 Rates.
August 24, 2007........... 48870 400 and 421............... CMS-6030-F............... Medicare
Program;
Medicare
Integrity
Program, Fiscal
Intermediary
and Carrier
Functions, and
Conflict of
Interest
Requirements.
August 24, 2007........... 48654 .......................... CMS-7005-N............... Medicare
Program;
Meeting of the
Advisory Panel
on Medicare
Education,
September 20,
2007.
[[Page 73998]]
August 24, 2007........... 48652 .......................... CMS-3184-N............... Medicare
Program;
Meeting of the
Medicare
Evidence
Development and
Coverage
Advisory
Committee
(MedCAC)--Octob
er 22, 2007.
August 24, 2007........... 48651 .......................... CMS-1481-N4.............. Medicare
Program;
Emergency
Medical
Treatment and
Labor Act
(EMTALA)
Technical
Advisory Group
(TAG) Meeting--
September 17-
18, 2007.
August 24, 2007........... 48650 .......................... CMS-3193-N............... Town Hall
Meeting
Regarding the
Effect of
Coverage and
Payment on
Clinical
Research Study
Participation
and Retention,
September 20,
2007.
August 24, 2007........... 48647 .......................... CMS-1542-N2.............. Medicare
Program;
Announcement of
New Members to
the Advisory
Panel on
Ambulatory
Payment
Classification
(APC) Groups.
August 24, 2007........... 48604 440....................... CMS-2234-P............... Medicaid
Program; State
Option To
Establish Non-
Emergency
Medical
Transportation
Program.
August 24, 2007........... 48562 482....................... CMS-3014-IFC............. Medicare and
Medicaid
Programs;
Hospital
Conditions of
Participation:
Laboratory
Services.
August 29, 2007........... 49762 484....................... CMS-1541-FC.............. Medicare
Program; Home
Health
Prospective
Payment System
Refinement and
Rate Update for
Calendar Year
2008.
August 31, 2007........... 50490 431 and 457............... CMS-6026-F............... Medicaid Program
and State
Children's
Health
Insurance
Program
(SCHIP);
Payment Error
Rate
Measurement.
August 31, 2007........... 50470 416....................... CMS-3887-P............... Medicare and
Medicaid
Programs;
Ambulatory
Surgical
Centers,
Conditions for
Coverage.
August 31, 2007........... 50214 418....................... CMS-1539-F............... Medicare
Program;
Hospice Wage
Index for
Fiscal Year
2008.
September 5, 2007......... 51012 411 and 424............... CMS-1810-F............... Medicare
Program;
Physicians'
Referrals to
Health Care
Entities With
Which They Have
Financial
Relationships
(Phase III).
September 7, 2007......... 51397 431, 433, and 440......... CMS-2287-P............... Medicaid
Program;
Elimination of
Reimbursement
Under Medicaid
for School
Administration
Expenditures
and Costs
Related to
Transportation
of School-Age
Children
Between Home
and School.
September 19, 2007........ 53628 424, 488, and 489......... CMS-2268-F............... Establishment of
Revisit User
Fee Program for
Medicare Survey
and
Certification
Activities.
September 28, 2007........ 55282 .......................... CMS-9041-N............... Medicare and
Medicaid
Programs;
Quarterly
Listing of
Program
Issuances--Apri
l Through June
2007.
September 28, 2007........ 55224 .......................... CMS-1378-N............... Medicare
Program;
Medicare
Provider
Feedback Group
Town Hall
Meeting--Octobe
r 16, 2007.
September 28, 2007........ 55222 .......................... CMS-3186-PN.............. Medicare and
Medicaid
Programs;
Application by
the Indian
Health Service
(IHS) for
Continued
Recognition as
a National
Accreditation
Organization
for Accrediting
American Indian
and Alaska
Native Entities
To Furnish
Outpatient
Diabetes Self-
Management
Training.
September 28, 2007........ 55219 .......................... CMS-2267-N............... Medicare,
Medicaid, and
CLIA Programs;
Clinical
Laboratory
Improvement
Amendments of
1988 Exemption
of Laboratories
Licensed by the
State of
Washington.
September 28, 2007........ 55158 440 and 447............... CMS-2213-P............... Medicaid
Program;
Clarification
of Outpatient
Clinic and
Hospital
Facility
Services
Definition and
Upper Payment
Limit.
September 28, 2007........ 55152 406, 407, and 408......... CMS-4129-P............... Medicare
Program;
Special
Enrollment
Period and
Medicare
Premium
Changes.
September 28, 2007........ 55085 409....................... CMS-1545-CN.............. Medicare
Program;
Prospective
Payment System
and
Consolidated
Billing for
Skilled Nursing
Facilities;
Corrections.
----------------------------------------------------------------------------------------------------------------
Addendum V--National Coverage Determinations [July Through September
2007]
A national coverage determination (NCD) is a determination by the
Secretary with respect to whether or not a particular item or service
is covered nationally under Title XVIII of the Social Security Act, but
does not include a determination of what code, if any, is assigned to a
particular item or service covered under this title, or determination
with respect to the amount of payment made for a particular item or
service so covered. We include below all of the NCDs that were issued
during the quarter covered by this notice. The entries below include
information concerning completed decisions as well as sections on
program and decision memoranda, which also announce pending decisions
or, in some cases, explain why it was not appropriate to issue an NCD.
We identify completed decisions by the section of the NCDM in which the
decision appears, the title, the date the publication was issued, and
the effective date of the decision. Information on completed decisions
as well as pending decisions has also been posted on the CMS Web site
at http://cms.hhs.gov/coverage.
[[Page 73999]]
National Coverage Determinations
[July through September 2007]
----------------------------------------------------------------------------------------------------------------
Title NCDM section TN number Issue date Effective date
----------------------------------------------------------------------------------------------------------------
Medicare Clinical Trial Policy.................. 310.1 R74NCD 9/07/07 07/09/07
Lumbar Artificial Disc Replacement.............. 150.10 R75NCD 09/11/07 08/14/07
Ultrasound Diagnostic Procedures................ 220.5 R76NCD 09/12/07 05/17/07
Percutaneous Transluminal Angioplasty........... 20.7 R77NCD 09/12/07 04/30/07
----------------------------------------------------------------------------------------------------------------
Addendum VI--FDA-Approved Category B IDEs [July Through September 2007]
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices
fall into one of three classes. To assist CMS under this categorization
process, the FDA assigns one of two categories to each FDA-approved
IDE. Category A refers to experimental IDEs, and Category B refers to
non-experimental IDEs. To obtain more information about the classes or
categories, please refer to the Federal Register notice published on
April 21, 1997 (62 FR 19328).
The following list includes all Category B IDEs approved by FDA
during the third quarter, July through September 2007.
------------------------------------------------------------------------
IDE Category
------------------------------------------------------------------------
BB13393................................... B
BB13423................................... B
BB13463................................... B
G060207................................... B
G070014................................... B
G070035................................... B
G070036................................... B
G070057................................... B
G070076................................... B
G070081................................... B
G070094................................... B
G070095................................... B
G070098................................... B
G070103................................... B
G070105................................... B
G070107................................... B
G070108................................... B
G070109................................... B
G070114................................... B
G070123................................... B
G070126................................... B
G070128................................... B
G070130................................... B
G070134................................... B
G070140................................... B
G070141................................... B
G070143................................... B
G070144................................... B
G070146................................... B
G070149................................... B
G070150................................... B
G070158................................... B
------------------------------------------------------------------------
Addendum VII--Approval Numbers for Collections of Information
Below we list all approval numbers for collections of information
in the referenced sections of CMS regulations in Title 42; Title 45,
Subchapter C; and Title 20 of the Code of Federal Regulations, which
have been approved by the Office of Management and Budget:
OMB Control Numbers
Approved CFR Sections in Title 42, Title 45, and Title 20 (Note:
Sections in Title 45 are preceded by ``45 CFR,'' and sections in Title
20 are preceded by ``20 CFR,'')
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OMB Number Approved CFR sections
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0938-0008................................. Part 424, Subpart C
0938-0022................................. 413.20, 413.24, 413.106
0938-0023................................. 424.103
0938-0025................................. 406.28, 407.27
0938-0027................................. 486.100-486.110
0938-0033................................. 405.807
0938-0034................................. 405.821
0938-0035................................. 407.40
0938-0037................................. 413.20, 413.24
0938-0041................................. 408.6, 408.202
0938-0