[Federal Register: June 25, 2004 (Volume 69, Number 122)]
[Notices]
[Page 35634-35650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn04-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9022-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--January 2004 Through March 2004
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 January 2004 through March 2004, relating to the
Medicare and Medicaid programs. This notice provides information on
national coverage determinations 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. Finally, this notice also includes listings
of all approval numbers from the Office of Management and Budget for
collections of information in CMS regulations.
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
[[Page 35635]]
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 have a specific information need and not be able to determine
from the listed information whether the issuance or regulation would
fulfill that need. Consequently, we are providing information 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 items in Addendum III may be addressed to
Karen Bowman, Office of Strategic Operations and Regulatory Affairs,
Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.
Questions concerning Medicare National Coverage Determinations
(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 Eileen Davidson, Office of Clinical
Standards and Quality, Centers for Medicare & Medicaid Services, S3-26-
10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-6874.
Questions concerning approval numbers for collections of
information in Addendum VII may be addressed to Dawn Willinghan, Office
of Strategic Operations and Regulatory Affairs, Regulations Development
and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-
26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-6141.
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, C5-12-26, 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, national coverage determinations (NCDs), and Food and Drug
Administration (FDA)-approved investigational device exemptions (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 National Coverage Determination 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 six 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--
--Date published;
--Federal Register citation;
--Parts of the Code of Federal Regulations (CFR) that have changed (if
applicable);
--Agency file code number; and
--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.
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
[[Page 35636]]
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. 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, 1999. (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 ``Restoring Composite
Rate Exceptions for Pediatric Facilities Under the End-Stage Renal
Disease Composite Rate System,'' use CMS-Pub. 100-02, Transmittal No.
07.
(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: June 14, 2004.
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.
January 10, 2000 (65 FR 1400)
May 30, 2000 (65 FR 34481)
June 28, 2002 (67 FR 43762)
September 27, 2002 (67 FR 61130)
December 27, 2002 (67 FR 79109)
March 28, 2003 (68 FR 15196)
June 27, 2003 (68 FR 38359)
September 26, 2003 (68 FR 55618)
December 24, 2003 (68 FR 74590)
March 26, 2004 (69 FR 15837)
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
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.
[[Page 35637]]
Addendum III--Medicare and Medicaid Manual Instructions
[January 2004 Through March 2004]
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Transmittal No. Manual/Subject/Publication No.
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Medicare General Information
(CMS-Pub. 10001)
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02 Scheduled Release for April Updates to
Software and Pricing/Codes Files
03 New Part B Annual Deductible
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Medicare Benefit Policy
(CMS-Pub. 10002)
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07 Restoring Composite Rate Exceptions for
Pediatric Facilities Under the End-Stage
Renal Disease Composite Rate System
08 Policy Changes to Reflect Billing for
Darbepoetin Alfa and Epoetin
-----------------------------
Medicare National Coverage Determinations
(CMS-Pub. 10003)
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07 Electrical Stimulation and Electromagnetic
Therapy for the Treatment of Wounds
08 Current Perception Threshold/Sensory Nerve
Conduction Threshold Test
09 Cardiac Output Monitoring by Thoracic
Electrical Bioimpendance
-----------------------------
Medicare Claims Processing
(CMS-Pub. 10004)
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60 Manualization of 2632, New Computer-Aided
Detection Codes for Screening and
Diagnostic Digital Mammography Services
Health Common Procedure Coding System and
Diagnosis Codes for Mammography Services
Computer-Aided Detection Addon Codes
Computer-Aided Detection Billing Charts
Outpatient Hospital Mammography Payment
Table
Payment for Computer Add-on Diagnostic and
Screening Mammograms for Fiscal
Intermediary and Carriers
Critical Access Hospital Payment
Critical Access Hospital Mammography
Payment Table
Skilled Nursing Facility Mammography
Payment Table
Rural Health Claim/Federally Qualified
Health Center Claims with Dates of
Service on or After January 1, 2002
Fiscal Intermediary Data for Common
Working File and the Provider Statistical
and Reimbursement Report
Carrier Processing Requirements
Part B Carrier Claim Record for Common
Working File
Carrier and Common Working File Edits
Mammograms Performed with New Technologies
61 Revises Diagnosis Coding Instructions for
Requests for Anticipated Payment and
Claims to Conform with Health Insurance
Portability and Accountability Act of
1996 Requirements
62 Correction to January 2004 Annual Update
of Health Common Procedure Coding System
Codes Used for Home Health Consolidated
Billing Enforcement
63 Special Rules for Critical Access Hospital
Outpatient Billing
64 Coding Change for Ventricular Assist
Devices for Beneficiaries in a
Medicare+Choice Plan
65 ANSI X12 Transaction 835 Companion
Document Change for Carriers, Durable
Medical Equipment Regional Carriers, and
Intermediaries
66 Quarterly Update to Correct Coding
Initiative Edits, Version 10.1, Effective
April 1, 2004
67 Revision to Change Request 2912: Coding,
Testing, and Implementation Phases of
Change Request 2631 for Jurisdiction
68 New Requirements for Critical Access
Hospitals. These Changes Have Been
Established with the Medicare
Prescription Drug Improvement, and
Modernization Act of 2003, PL 108173
69 Criteria for Using the CB Modifier
70 Implementation of the Annual Desk Review
Program for Hospital Wage Data: Cost
Reporting Periods Beginning On or After
October 1, 2000, Through September 30,
2001 (Fiscal Year 2005 Wage Index)
71 Changes to the Laboratory National
Coverage Determination Edit Software for
April 2004
72 Update of Address for the Railroad
Retirement Board
73 Medicare Code Editor and IPPS Transfers
between Hospitals
74 Intravenous Immune Globulin
75 Medicare Modernization Act Pricing File
Clarifications
76 Manualization of Skilled Nursing
Facilities Inpatient Part A Billing
Services Included in Part A PPS Payment
Not Billable Separately by the Skilled
Nursing Facility
Services Beyond the Scope of the Part A
Skilled Nursing Facility Benefit Carrier
Claims Processing for Consolidated
Billing for Physician and Non-Physician
Practitioner Services Rendered to
Beneficiaries in a Part A Skilled Nursing
Facility Stay
Correct Place of Service Code for Skilled
Nursing Facility Claims
Common Working File Edits
Reject and Unsolicited Response Edits
Utilization Edits
Duplicate Edits
Edit for Ambulance Services
Edit for Clinical Social Workers
Common Working File Override Codes
Coding Files and Updates
[[Page 35638]]
Annual Update Process
Beneficiaries in a Part A Covered Stay
Carrier Claims Processing for Consolidated
Billing for Physician and Physician
Practitioner Services Rendered to
Beneficiaries in a NonCovered Skilled
Nursing Facility Stay
77 Change in Methodology for Determining
Payment for Outliers
Outlier Payments: CosttoCharge Ratios
78 Update to Medicare Secondary Payment
Module to Apportion Prospective Payment
System Outlier Amounts to All Service and
APC Lines That are Pricer Related
Billing and Payment in a Health
Professional Shortage Area
79 End Stage Renal Disease Reimbursement for
Automated MultiChannel Chemistry Test(s)
80 Extend Medicare Coverage for Certain
Colorectal Cancer Screenings at Skilled
Nursing Facility
Billing Requirements for Claims Submitted
to Intermediaries
81 Report Of Admission Date and Additional
Edit Requirements for the X12N 837
Coordination of Benefits Transaction
Form Locator 2 Untitled
82 EndStage Renal Disease Data for Use In
Adjudicating Claims
Utilization of REMIS for Carrier Claims
Adjudication
83 New ``K'' Codes for Wheelchair Cushions
84 Additional Guidelines for Implementing the
National Council for Prescription Drug
Program
National Council for Prescription Drug
Program Implementation
85 Payment of Skilled Nursing Facility Claims
for Beneficiaries Disenrolling From
Terminating Medicare+Choice
Definitions
Laboratories Billing for Referred Tests
Claims Information and Claims Forms and
Formats
Paper Claim Submission to Carriers
Electronic Claim Submission to Carriers
Referring Laboratories
Reporting of Pricing Localities for
Clinical Laboratory Services
Jurisdiction of Referral Laboratory
Services
Examples of Reference Laboratory
Jurisdiction Rules
86 X12N 837 Professional Implementation Guide
Edits
87 Coverage and Billing for Home Prothrombin
Time International Normalized Ratio
Anticoagulation Management
IPPS Transfers Between Hospitals
88 Implementation of Section 414 of the
Medicare Prescription Drug, Improvement,
and Modernization Act of 2003
General Coverage and Payment Policies
Billing Methods
Definitions
Intermediary and Carrier Calculation of
Payment Amount
General
Components of the Ambulance Fee Schedule
ZIP Code Determines Fee Schedule Amounts
Transition Overview
89 2003 Clinical Lab Fee Schedule and Lab
Services Subject to Reasonable Charge
Elimination of the 90day Grace Period for
Health Common Procedure Coding System
(Level I and Level II)
Deleted Health Common Procedure Coding
System Codes/Modifiers
Access to Clinical Diagnostic Lab Fee
Schedule Files
Fee Schedules Used by All Intermediaries
and Regional Home Health Intermediaries
90 Bundled Services for Skilled Nursing
Facility
Edit for Therapy Services Separately
Payable When Furnished by a Physician
91 CR 3077, Processing NonCovered Home Health
Prospective Payment System Charges
Intermediary Processing of NoPayment Bills
92 CR 3070, April Quarterly Update to Jan
2004 Annual Update of Health
Common Procedure Coding System Used for
Skilled Nursing Facility
Consolidated Billing Enforcement
Consolidated Billing Requirements for
Skilled Nursing Facility
Services Included in Part A PPS Payment
Not Billable Separately by the Skilled
Nursing Facility
Other Excluded Services Beyond the Scope
of a Skilled Nursing Facility
Part A Benefit
Cardiac Catheterization
Computerized Axial Tomography Scans
Magnetic Resonance Imaging
Outpatient Surgery and Related Procedures--
Inclusion
Radiation Therapy
Angiography, Lymphatic, Venous and Related
Procedures
Emergency Services
Services Excluded from Part A PPS Payment
and the Consolidated Billing
Requirement on the Basis of Beneficiary
Characteristics and Election
ESRD Services
Coding Applicable to Services Provided in
a Renal Dialysis Facility or Skilled
Nursing Facility as Home
[[Page 35639]]
Coding Applicable to EPO Services
Other Services Excluded from Skilled
Nursing Facility Prospective Payment
System and Consolidated Billing
Ambulance Services
Chemotherapy, Chemotherapy Administration,
and Radioisotope Services
Certain Customized Prosthetic Devices
Screening and Preventive Services
Therapy Services
93 Remittance Advice Remark Code and Claim
Adjustment Reason Code Update CR 3122
94 Additional Information in Medicare Summary
Notices to Beneficiaries About Skilled
Nursing Facility Benefits CR 3098
Other Billing Situations
Skilled Nursing Facilities
Benefit Limits
Instalacion de Enferemeria Especializada
Limites En Los Beneficios
95 Elimination of the 90-day Grace Period for
ICD 9-CM Codes CR 3094
Relationship of ICD-9-CM Codes and Date of
Service
96 Update to Claims Status Codes CR 3017
Health Care Claims Status Category Codes
and Health Care Claim Status Codes For
Use with the Health Care Claim Status
Request and Response ASC X12N 276/277
97 Implementation of New Medicare
Redetermination Notice CR 2620
98 Consolidation of Claims Crossover Process:
Common Working File Functionality
Crossover Claims Requirements
Fiscal Intermediary Requirements
Carrier/Durable Medical Equipment Regional
Carrier Requirements
Consolidated Claims Crossover Process
Claims Crossover Disposition Indicators
Assignment of Claims and Transfer Policy
Beneficiary Insurance Assignment Selection
Form CMS-1500 (ANSI X12N 837 COB (Version
4010)
Remittance Advice Messages
Returned Medigap Notices
Coordination of Medicare with Medigap and
Other Complementary Health Insurance
Policies
Standard Medicare Charges for COB Records
Consolidation of the Claims Crossover
Process
Electronic Transmission--General
Requirements
ANSI X12N 837 COB (Version 4010)
Transaction Fee Collection
Medigap Electronic Claims Transfer
Agreements
Intermediary Crossover Claim Requirements
Carrier/DMERC Crossover Claim Requirements
99 HIPAA X12N 837 Coordination of Benefits
Gap Fill Additional Instruction CR 3100
Crossover Requirements
100 Outpatient Clinical Laboratory Tests
Furnished by Hospitals with Fewer than 50
Beds in Qualified Rural Areas CR 3130
Hospital Billing Under Part B
101 Restoring Composite Rate Exceptions for
Pediatric Facilities Under the End-Stage
Renal Disease Composite Rate System CR
3119
Processing Requests for Composite Rate
Exception
102 New Waived Test--April 1, 2004 Certificate
of Waiver
103 Optional Method for Outpatient Services:
Cost-Based Facility Services Plus 115
Percent Fee Schedule Payment for
Professional Services CR 3114
104 Durable Medical Equipment Regional Carrier
and VMS-Instructions for Processing CR
3141
Billing Drugs Electronically--National
Council of Prescription Drug Programs
105 First Update to the 2004 Medicare
Physician Fee Schedule Database CR 3128
106 Modification of Requirements in CR 2716,
Common Working File Edits to Ensure
Accurate Coding and Payment for Discharge
and/or Transfer Policies CR 3137
107 Health Insurance Portability and
Accountability of Act of 1996 X12N 837
Health Care Claim Implementation Guide
Editing Additional Instruction CR 3031
X12N 837 Institutional Implementation
Guide Edits
FI Requirements
Edits Performed by the Fiscal Intermediary
108 Type of Service Corrections, Chapter 26,
Section 10.7 CR 3018
109 Updated Policy and Claims Processing
Instructions for Ambulatory Blood
Pressure Monitoring Billing CR 2726
Diagnostic Blood Pressure Monitoring
Ambulatory Blood Pressure Monitoring
Billing Requirements
110 New Requirement for Payment of Drugs CR
3078
Drugs Furnished in Dialysis Facilities
111 Payment for Services Provided Under a
Contractual Arrangement CR 3083
General Billing Requirements
Payment to Facility in Which Services Are
Performed--Carrier Claims
Carrier Payment to Health Care Delivery
System--Carrier Claims
Definition of Health Care Delivery System
[[Page 35640]]
112 Changes to Outpatient Prospective Payment
System Change Request 3144
113 Claims Requiring Adjustment as a Result of
April 2004 Changes to the Outpatient
Prospective Payment System Change Request
3145
114 Changes in Payment Floor Calculation for
Claims Submitted Electronically in a Non-
HIPAA Change Request 2981
Receipt Date
Payment Ceiling Standards
Payment Floor Standards
Determining and Paying Interest
115 Durable Medical Equipment Regional Carrier
and Voucher Insurance Plan, Processing
National Drug Code Numbers--Clarification
to Change Request 3141
116 End-Stage Renal Disease Miscellaneous Code
Processing Clarification
Durable Medical Equipment Regional Carrier
Claims Processing Instructions
117 Instructions for Downloading the Medicare
Zip Code File
118 Policy Changes To Reflect Billing for
Darbepoetin Alfa and Epoetin Epoetin Alfa
(EPO) Facility Billing Requirements Using
UB-92/Form CMS-1450
Other Information Required on the Form CMS-
1500 for Epoetin Alfa (EPO)
Completion of Subsequent Form CMS-1500
Claims for Epoetin Alfa (EPO)
Payment Amount for Epoetin Alfa (EPO)
Payment for Epoetin Alfa (EPO) in Other
Settings
Epoetin Alfa (EPO) Provided in the
Hospital Outpatient Departments
Epoetin Alfa (EPO) Furnished to Home
Patients
Darbepoetin Alfa (Aranesp) for ESRD
Patient
Darbepoetin Alfa (Aranesp) Facility
Billing Requirements Using UB-92/Form CMS-
1450
Darbepoetin Alfa (Aranesp) Supplier
Billing Requirements (Method II) on the
Form CMS-1500 and Electronic Equivalent
Other Information Required on the Form CMS-
1500 for Darbepoetin Alfa (Aranesp)
Completion of Subsequent Forms CMS-1500
Claims for Darbepoetin Alfa (Aranesp)
Payment Amount for Darbepoetin Alfa
(Aranesp)
Payment for Darbepoetin Alfa (Aranesp) in
Other Settings
Payment for Darbepoetin Alfa (Aranesp) in
the Hospital Outpatient Department
Darbepoetin Alfa (Aranesp) Furnished to
Home Patients
Billable UB-92 Revenue Codes Under Method
II
119 Medicare Modernization Act Drug Pricing
Update-Drug Exceptions
120 January Medicare OCE Specifications
Version 19.1R1
121 Manualization of Place of Service Code Set
Program Memorandum Revision to Group Home
Code Description
Item 14-33--Provider of Service or
Supplier Information
Place of Service Codes (POS) and
Definitions
122 Revision to Required Messages in Change
Request 2944, Implementation of Skilled
Nursing Facility/Consolidated Billing
Edit for Therapy Codes
123 April Outpatient Code Editor
124 Billing and Coding Requirements for
Electromagnetic Therapy for the
Treatment of Wounds
Wound Treatments
Electrical Stimulation
Electromagnetic Therapy
125 Manualization of the Sacral Nerve
Stimulation
Sacral Nerve Stimulation
Coverage Requirements
Billing Requirements
Healthcare Common Procedural Coding System
Payment Requirements for Test Procedures
(Healthcare Common Procedural Coding
System Codes 64585, 64590, and 64595
Payment Requirements for Device Codes
A4290, E0752, and E0756
Payment Requirements for Codes C1767,
C1778, C1883, and C1897
Bill Types
Revenue Codes
Claims Editing
126 Clarification of ICD-9-Coding
Clarification of ICD-9-CM Diagnosis and
Procedure Codes
127 2004 Jurisdiction List
Use and Acceptance Healthcare Common
Procedural Codes and Modifiers
128 Deep Brain Stimulation for Essential
Tremor and Parkinson's Disease
Coverage
Billing Requirements
Part A Intermediary Billing Procedures
Payment Requirements
Part A Methods
Bill Types
Revenue Codes
Allowable Codes
Allowable Covered Diagnosis Codes
Allowable Covered Procedure Codes
[[Page 35641]]
Healthcare Common Procedure Coding System
Ambulatory Surgical Centers
Claims Editing for Intermediaries
Remittance Advice Notice for
Intermediaries
Medicare Summary Notices Messages for
Intermediaries Provider Notification
129 Additional Info and Corrections to
Previous Transmittals Re: HCPCS Codes and
Modifiers for Low Osmolar, etc.
130 Chapter 32, Section 60 ff
Coverage Billing for Home Prothrombin Time
(INR) Monitoring for Anticoagulation
Management
Coverage Requirements
Intermediary Payment Requirements
Part A Payment Methods
Intermediary Billing Procedures
Bill Types
Revenue Codes
Intermediary Allowable Codes
Allowable Covered Diagnosis Codes
Healthcare Common Procedure Coding System
for Intermediaries
Carrier Billing Instructions
Healthcare Common Procedure Coding System
for Carriers
Applicable Diagnosis Code for Carriers
Carrier Claims Requirements
Carrier Payment Requirements
Carrier and Intermediary General Claims
Processing Instructions
Remittance Advice Notice
Medicare Summary Notice Messages
131 Revised Payment Allowance Percentage for
Durable Medical Equipment
Regional Carrier Drugs--Off Cycle Release
Payment Allowance Limit for Drugs and
Biologicals Not Paid on a Cost or
Prospective Payment Basis
132 April 2004 Update of the Hospital
Outpatient Prospective Payment System
Updates
-----------------------------
Medicare Secondary Payer
(CMS-Pub. 100-05)
------------------------------------------------------------------------
08 Common Working File Medicare Secondary
Payor Modifications Change Request 2775
Medicare Secondary Payor Add Transactions
Medicare Secondary Payor Change
Transaction
Medicare Secondary Payor Delete
Transaction
Automatic Notice of Change to Medicare
Secondary Payor Auxiliary File
09 Converting Health Insurance Portability
and Accountability Act of 1996 Individual
Relation Change Request 3116
Conversion of Health Insurance Portability
and Accountability Act of 1996 Individual
Relationship Codes to Common Work File
Patient Relationship Codes for the
Creation of Medicare Secondary Payor HUSP
Transactions
10 Update to the Shared Systems to Send the
Appropriate Medicare Fee Schedule Amount
Change Request 2955
11 Medicare Secondary Payor Policy for
Certain Services Change Request 3064
General Policy
Selection of Bill Sample
12 Interim Non-System Solution: Converting
Health Insurance Portability and
Accountability Act Individuals
Relationship Codes to Common Working File
Converting Health Insurance Portability
and Accountability Act Individual
Relationship Codes to Common Working File
Patient Relationship Codes
13 Update to the ECRS User Guide v7.0 and
Quick Reference Card v7.0
-----------------------------
Medicare Financial Management
(CMS-Pub. 100-06)
------------------------------------------------------------------------
33 Coordination of Medicare and Complementary
Insurance Programs
Coordination of Medicare with the Federal
Grants-In-Aid Program
Furnishing Title XVIII Claims Information
Treatment of Administrative Cost of
Furnishing Information to State Agencies
Coordination of Medicare and Medicare
Supplemental (Medigap) Health Insurance
Policies
34 Chapter 7--Internal Control Requirements
Update
Risk Assessment
Fiscal Year 2004 Medicare Control
Objectives
Requirements
Certification Statement
Executive Summary
Report of Material Weaknesses
Report of Reportable Conditions
35 Unsolicited/Voluntary Refunds
General Information
Office of the Inspector General
Initiatives
Unsolicited/Voluntary Refund Accounts
[[Page 35642]]
Receiving and Processing Unsolicited/
Voluntary Refund Checks When Identifying
Information is Provided
Handling Checks or Associated
Correspondence with Conditional
Endorsements
Receiving and Processing Unsolicited/
Voluntary Refund Checks When Identifying
Information Is Not Provided
CMS Reporting Requirements
Overpayment Refund--Summary Report
Unsolicited/Voluntary Refund Checks--
Summary Report Education
36 Medicare Contractor Transaction Report
Due Date
Heading
Body of Report
37 Installation of Version 33 of the Provider
Statistical and Reimbursement
Reporting System.
-----------------------------
Medicare Program Integrity
(CMS-Pub. 100-08)
------------------------------------------------------------------------
66 Progressive Corrective Action
General Information
Review of Data
Probe Reviews
Target Medical Review Activities
Requesting Additional Information
Provider Error Rate
Provider Feedback and Education
Overpayments
Fraud
Track Interventions
Track Appeals
Implementation
Vignettes
67 The Medicare Coverage Databases Change
Request 2976
Comprehensive Error Rate Testing Program
Safeguard Contractor
Affiliated Contractor Full PSC
Communication with the Comprehensive
Error Rate Testing Contractor
Overview of the Comprehensive Error Rate
Testing Process
AC/Full PSC Requirements Surrounding
Comprehensive Error Rate Testing Reviews
Providing Sample Information to the
Comprehensive Error Rate Testing
Contractor
Providing Review Information to the
Comprehensive Error Rate Testing
Contractor
Providing Feedback Information to the
Comprehensive Error Rate Testing
Contractor
Disputing/Disagreeing with a Comprehensive
Error Rate Testing Decision
Handling Overpayments and Underpayments
Resulting from the Comprehensive Error
Rate Testing Findings
Handling Appeals Resulting from
Comprehensive Error Rate Testing
Initiated Denials
Tracking Overpayments and Appeals
Potential Fraud
AC/Full PSC Requirements Involving
Comprehensive Error Rate Testing
Information Dissemination
AC/Full PSC CERT Points of Contact
AC/Full PSC Error Rate Reduction Plan
68 Program Requirements to Support Medical
Review of Home Health Prospective
Payment System Change Request 2519
69 Revision of Enrollment Instructions Change
Request 3159
Contractor Duties
Processing the Application
Identification
Practice Location
Ownership and Managing Control Information
(Individuals)
Qualification of Crew
Review of Attachment 2, Independent
Diagnostic Testing Facilities
Reassignment of Benefits
Statement of Termination
Reassignment of Benefits Statement
Attestation Statement
Practice Location
Ownership and Managing Control Information
(Individuals)
Changes of Information--New Form CMS855
Data
Approval and Recommendations for Approval
Time Frame for Application Processing
-----------------------------
Medicare Contractor Beneficiary And Provider Communications
(CMS Pub. 100-09)
------------------------------------------------------------------------
04 Provider/Supplier Communications
[[Page 35643]]
Introduction
Provider Communications--Program Elements
Provider Service Plan
Provider Inquiry Analysis
Provider Data Analysis
Provider Communications Advisory Group
Bulletins/Newsletters
Seminars/Workshops/Teleconferences
New Technologies/Electronic Media
Training of Providers in Electronic Claims
Submission
Provider Education and Beneficiary Use of
Preventive Benefits
Internal Development of Provider Issues
Training of Provider Education Staff
Partnering with External Entities
Other Provider Education Subjects and
Activities
Provider Education Material
Provider Service Plan Quarterly Activity
Report
Charging Fees to Providers for Medicare
Education and Training Activities
Provider Information and Education
Materials and Resource Directory
Provider/Supplier Communication--Program
Elements
Provider/Supplier Service Plan
Provider/Supplier Inquiry Analysis
Provider/Supplier Data Analysis
Provider/Supplier Communications Advisory
Group
Bulletins/Newsletters
Seminars/Workshops/Teleconferences
New Technologies/Electronic Media
Training of Providers/Suppliers in
Electronic Claims Submission
Provider/Supplier Education and
Beneficiary Use of Preventive Benefits
Internal Development of Provider/Supplier
Issues
Training of Provider/Supplier Education
Staff
Partnering with External Entities
Other Specific Provider/Supplier Education
Subjects and Activities
Provider/Supplier Education Material
PSP Quarterly Activity Report
Charging Fees to Providers/Suppliers for
Medicare Education and Training
Activities
Provider/Supplier Information and
Education Materials and Resource
Directory
-----------------------------
Medicare EndStage Renal Disease Network Organizations
(CMS Pub. 10014)
------------------------------------------------------------------------
05 Chapter 4 Information Management
Background/Authority
Responsibilities
System Capacity
Hardware/Software Requirements
CMS Computer Systems Access
Data Security
Confidentiality of Data
Database Management
Patient Database Mandatory Data Element
Patient Database Updates
CMSDirected Changes (Notifications) to the
Network Patient Database
Facility Database Mandatory Data Elements
Submission of Facility Database Elements
ESRD Data and Reporting Requirements
Centers for Medicare & Medicaid Services
EndStage Renal Disease Forms
Centers for Medicare & Medicaid Services
EndStage Renal Disease Program Forms
Centers for Medicare & Medicaid Services
EndStage Renal Disease Clinical
Performance Measures Data Forms
CMS ESRD Beneficiary Selection Form
Collection, Completion, Validation, and
Maintenance of the EndStage Renal Disease
CMS Forms
Processing Form CMS-2728-U3
Processing Form CMS-2746 (EndStage Renal
Disease Death Notification Form)
Processing Form CMS2744 (EndStage Renal
Disease Facility Survey)
Tracking System for EndStage Renal Disease
Forms
Compliance Rates for Submitting EndStage
Renal Disease Forms
CMS Forms Data Discrepancies and Data
Corrections
Renal Transplant Data
Reporting on Continued Status of Medicare
EndStage Renal Disease
[[Page 35644]]
Beneficiaries
Coordination of Additional Renal Related
Information
VISION Data Validation
06 Chapter 6--Community Information and
Resources
Quarterly Progress and Status Report
Provision of Educational Information--
Providers/Facilities
Provision of Educational Information--
Patients
Provision of Technical Assistance
Resolution of Difficult Situations and
Grievances
07 Chapter 7--Sanctions and EndStage Renal
Disease
Complaint Grievances
Network's Role Prior to Initiating
Sanction Recommendations
Written Documentation Requirements for
Sanction Recommendations
Forwarding Sanction Recommendations
Project Officer's Role in Sanction
Procedures
Regional Officer's Role in Sanction
Procedures
Duration and Removal of Alternative
Sanctions
Quality of Care Referrals
Definitions for the EndStage Renal Disease
Complaint and Grievance Process
Role of Network in a Complaint/Grievance
End-Stage Renal Disease Complaint and
Grievance Process
Facility Awareness of the Complaint/
Grievance Process
Use of Facility Complaint/Grievance
Process
Determination of Network Involvement
Receiving a Complaint/Grievance
Request of Grievance in Writing
Referring Complaints and Grievances
Written Acknowledgment of Grievance
Investigation of Complaints and Grievances
Life-Threatening Situations
Challenging Patient Situations
Advocating for Patient Rights
Addressing a Complaint or Grievance
Follow-Up of a Grievance
Conclusion of a Grievance Investigation
Report and Letter to the Grievant
Complaint/Grievance Is Closed
Complaint/Grievance Is Resolved
Complaint/Grievance Is Referred
Complaint/Grievance Is Reopened
Improvement Plans
Content of Improvement Plans Time Period
for Review and Acceptance/Rejection of
Improvement Plans Tracking System
Conclusion of Improvement Plans Identity
of Complainant/Grievant
Identity of Practitioner
Identity of Facility
Personal Representative
-----------------------------
Medicare Managed Care
(CMS Pub. 100-16)
------------------------------------------------------------------------
45 Chapter 13 Revision 1
Written Notification by Medicare+Choice
Organizations
Withdrawal of Request for Reconsideration
Filing a Request for DAB Review
Standard Service Requests
Effectuating Decisions by All Other Review
Entities
Independent Review Entity Monitoring of
Effectuation Requirements Data
46 Chapter 19--January Updates
General
Cost-Based Managed Care Organizations Only
Medicare+Choice Managed Care Organizations
Only
Cost-Based Managed Care Organizations Only
Medicare+Choice Organizations Only
Submission of Correction Transaction
Records
Prior Commercial Months Field
''Special Status'' Beneficiaries--
Medicare+Choice Organizations
``Special Status''--Hospice
``Special Status''--End-Stage Renal
Disease
``Special Status''--Institutionalized
``Special Status''--Working Aged
[[Page 35645]]
When to Submit ``Special Status''
Information (Medicare+Choice
Organizations Only)
Timeliness Requirements
Sending the Transaction File to Centers
for Medicare & Medicaid Services
Electronic Data Transfer
Data Processing Vendor
CMS' Transaction Reply/Monthly Activity
Report
Transaction Reply Field Information
Plan Payment Report
Demographic Report Managed Care
Organizations Only
Monthly Membership Report
Bonus Payment Report
Retroactive Payment Adjustment Policy
Standard Operating Procedures for State
and County Code Adjustments
Standard Operating Procedures for Medicaid
Retroactive Adjustments
Standard Operating Procedures for EndStage
Renal Disease Retroactive Adjustments
Processing of Working Aged Retroactive
Adjustments
Standard Operating Procedures for
Retroactive Adjustment of Plan Elections
Medicare Customer Service Center
Disenrollments
Duplicate Payment Prevention by CostBased
Managed Care Organization
47 Chapter 7--Medicare+ChoiceEnrollment and
Disenrollment
Prefatory Note
General Rules for M+C Payments
Enrollees With End-Stage Renal Disease
Medicare+Choice Payment Methodology
A Minimum Specified Amount or ``Floor''
Rate
Adjustment of Capitation Rates for
National Coverage Determinations and
Legislative Changes in Benefits
Criteria for Meeting ``Significant Cost''
Rules Coverage and Payment of
``Significant Cost'' National Coverage
Determination
Before Adjustments to Annual
Medicare+Choice Capitation Rate Are
Effective
After Adjustments to the Annual
Medicare+Choice Capitation Rates Are in
Effect
Adjustment of Capitation Rates for Working
Aged Status
Adjustment of Capitation Rates for
Demographic Characteristics and Health
Status
Transition to a Comprehensive Risk
Adjustment Method
Transition Schedule for Implementation of
the Risk Adjustment Method
The CMS-HCC Risk Adjustment Method for
Adjustment of Capitation Rates
Demographic Factors Under the CMS-HCC Risk
Adjustment Method
Age and Sex
Medicaid Eligibility
Originally Disabled
The Medicare+Choice-Health Care Compare
Classification System
Institutional Adjuster in the CMS-Health
Care Compare Model
Implementation of the CMS-Health Care
Compare Model
Elimination of the Data Lag
Implementation of the Adjustment for Long-
Term Institutionalization
New Enrollees
Calculation of Beneficiary Risk Scores
Calculation of Monthly Payments to
Medicare+Choice Organizations
The Rescaling Factor
Adjustment to Rescaling Factors for Budget
Neutrality
Adjustment in Rescaling Factors for Coding
Intensity
Calculating the Payment Amount Per
Medicare+Choice Enrollee
Changes in Methodology for PACE and
Certain Demonstrations
Application of Frailty Model
Application of Frailty Factor to
Medicare+Choice Organizations
Exclusions from Risk Adjustment Payment
Data Collection and Submission for Risk
Adjustment Care
Hospital Inpatient Data
Outpatient Hospital
Physician Data
Alternative Data Sources
Data Collection
Diagnosis Submission
Submission Methods
Submission Frequency
Certification of Data Accuracy,
Completeness, and Truthfulness
Data Validation
Announcement of Annual Capitation Rates
and Methodology Change
Terminology
Policy
Special Rules for Medicare+Choice Payments
to Department of Veterans Affairs
Facilities
[[Page 35646]]
Eligibility for Bonus Payment/The Period
of Application
Reconciliation Process for Changes in Risk
Adjustment Factors
Additional Information on Coverage of
Clinical Trials
Community and Institutional Annual Risk
Factors for the CMS-Health Care
Compare Model with Constraints and
Demographic/Disease Interactions
List of Disease Groups (Health Care
Compare) with Hierarchies
CMS-HCC Demographic Model for New
Enrollees
Data Collection for Risk Adjustment/
Facility Types and Physician Specialties
Retired Material on the PIP-DCG Payment
Methodology (Former Sections 90 and 110,
Exhibits 4 and 5)
Retired Material on the Congestive Heart
Failure Extra Payment Initiative (Former
Section 100 and Exhibits 6 and 7)
48 Grievances, Organization Determinations,
and Appeals
49 Chapter 4--Benefits and Beneficiary
Protections
Access and Availability Rules for
Coordinated Care Plans
Rules for All Medicare+Choice
Organizations to Ensure Continuity of
Care
50 Chapter 20--Plan Communications Guide
View Beneficiary Factors (Option 9)
System Description
GROUCH Options
Downloading Your Group Health Plan Monthly
Report
The Common Working File
Logging Onto Common Working File
Beneficiary Eligibility Data
51 Revisions to Chapter 2--Medicare+Choice
Enrollment and Disenrollment
End-Stage Renal Disease
End-Stage Renal Disease and Enrollment
Effective Date
-----------------------------
Medicare Business Partners Systems Security
(CMS-Pub. 100-17)
------------------------------------------------------------------------
04 Federal Laws
Introduction
The (Principal) Systems Security Officer
IT Systems Security Program Management
System Security Plan
Risk Assessment
Certification
Information Technology Systems Contingency
Plan
Annual Compliance Audit
Corrective Action Plan
Computer Security Incident Response
Information Security Levels
Level 4: High Criticality and National
Security Interest
Sensitive Information Protection
Requirements
Restricted Area
Security Room
Secured Interior/Secured Perimeter
Container
Locked Container
Security Container
Safe/Vaults
Locking Systems for Secured Areas and
Security Rooms
Intrusion Detection Equipment
Internet Security
Core Security Requirements and the
Contractor Assessment Security Tool
CMS Core Set of Security Requirements
Medicare Information Technology Systems
Contingency Planning
An Approach to Fraud Control
Glossary
-----------------------------
One Time Notification
(CMS Pub. 10020)
------------------------------------------------------------------------
56 Program Integrity Management Reporting
System for Part A Phase 4
57 Instructions for Fiscal Intermediary
Standard System and MultiCarrier System
Healthcare Integrated General Ledger
Accounting Systems Changes
58 Program Integrity Management Reporting
System Fiscal Year 2004 H and T Codes
59 Temporary 5 % Payment Increase for Home
Health Services Furnished in a Rural Area
CR 3085
60 Instructions for Fiscal Intermediary
Standard System and MultiCarrier System
Healthcare Integrated General Ledger
Accounting System Changes
[[Page 35647]]
61 FY 2004 Graduate Medical Education
Payments as Required by the Medicare
Modernization Act of 2003
62 Physician SelfReferral Prohibition 12/22/
2003 18Month Moratorium on Physician
Investment in Specialty Hospitals CR 3036
63 Durable Medical Equipment Regional
Carriers DeWall Posture Protector
64 Implementation of Sections 401, 402, 504,
and 508(a) of the Medicare Modernization
Act of 2003
65 Implementation of Sec. 508(f) of the
Medicare Prescription Drug, Improvement,
and Modernization Act of 2003
66 CWF Corrections to the 270/271 Transaction
------------------------------------------------------------------------
Addendum IV.--Regulation Documents Published in the Federal Register
(January 2004 Through March 2004)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FR vol.
Publication date 69 page CFR parts affected File code Title of regulation
number
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 6, 2004....................... 820 42 CFR Part 419................................ CMS-1371-IFC............. Medicare Program; Hospital
Outpatient Prospective
Payment System; Payment
Reform for Calendar Year
2004.
January 6, 2004....................... 665 ............................................... CMS-4065-N............... Medicare Program; Meeting
of the Advisory Panel on
Medicare Education.
January 6, 2004....................... 661 ............................................... CMS-1373-N............... Medicare Program; Notice of
One-Time Appeal Process
for Hospital Wage Index
Classification.
January 6, 2004....................... 565 42 CFR Part 447................................ CMS-2188-P............... Medicaid Program; Time
Limitation on
Recordkeeping Requirements
Under the Drug Rebate
Program.
January 7, 2004....................... 508 42 CFR Part 447................................ CMS-2175-IFC............. Medicare Program; Time
Limitation on
Recordkeeping Requirements
Under the Drug Rebate
Program.
January 7, 2004....................... 1084 42 CFR Parts 405 and 414....................... CMS-1372-IFC............. Medicare Program; Changes
to Medicare Payment for
Drugs and Physician Fee
Schedule Payments for
Calendar Year 2004.
January 23, 2004...................... 3434 45 CFR Part 162................................ CMS-0045-F............... HIPAA Administrative
Simplification: Standard
Unique Health Identifier
for Health Care Providers.
January 23, 2004...................... 3371 ............................................... CMS-1362-N............... Medicare Program; February
23-24, 2004, Meeting of
the Practicing Physicians
Advisory Council.
January 23, 2004...................... 3370 ............................................... CMS-1375-N............... Medicare Program; Request
for Nominations to the
Advisory Panel on
Ambulatory Payment
Classifications Group.
January 30, 2004...................... 4820 42 CFR Part 412................................ CMS-1263-P............... Medicare Program;
Prospective Payment System
for Long-Term Care
Hospitals: Proposed Annual
Payment Rate Updates and
Policy Changes.
January 30, 2004...................... 4464 42 CFR Parts 412, 413, and 424................. CMS-1213-N............... Medicare Program;
Prospective Payment System
for Inpatient Psychiatric
Facilities; Extension of
Comment Period.
February 13, 2004..................... 7340 ............................................... CMS-1373-N2.............. Medicare Program; Revisions
to the One-Time Appeal
Process for Hospital Wage
Index Classification.
February 27, 2004..................... 9326 ............................................... CMS-2200-N............... Medicare Program; Request
for Nominations for the
State Pharmaceutical
Assistance Transition
Commission.
February 27, 2004..................... 9324 ............................................... CMS-1268-N............... Medicare Program; Town Hall
Meeting on the Fiscal Year
2005 Applications for New
Medical Services and
Technologies Add-on
Payments Under the
Hospital Inpatient
Prospective Payment.
February 27, 2004..................... 9323 ............................................... CMS-4090-N............... Medicare Program; Town Hall
Meeting on Proposed
Collection--Comment
Request for Skilled
Nursing Facility Advance
Beneficiary Notice.
February 27, 2004..................... 9322 ............................................... CMS-3112-N............... Medicare Program; Calendar
Year 2004 Review of the
Appropriateness of Payment
Amounts for New Technology
Intraocular Lenses
(NTIOLs) Furnished by
Ambulatory Surgical
Centers (ASCs).
February 27, 2004..................... 9321 ............................................... CMS-4070-N............... Medicare Program; Request
for Nominations for the
Advisory Panel on Medicare
Education.
February 27, 2004..................... 9282 42 CFR Part 473................................ CMS-3121-P............... Medicare and Medicaid
Programs; Requirements for
Long Term Care Facilities;
Nursing Services; Posting
of Nurse Staffing
Information.
March 5, 2004......................... 10455 ............................................... CMS-2200-N2.............. Medicare Program;
Establishment of the State
Pharmaceutical Assistance
Transition Commission.
[[Page 35648]]
March 26, 2004........................ 16054 42 CFR Parts 411 and 424....................... CMS-1810-IFC............. Medicare Program;
Physicians' Referrals to
Health Care Entities With
Which They Have Financial
Relationships.
March 26, 2004........................ 15884 ............................................... CMS-4071-N............... Medicare Program; Listening
Session on Performance
Measures for Public
Reporting on the Quality
of Hospital Care--April
27, 2004.
March 26, 2004........................ 15850 ............................................... CMS-2062-N............... Medicaid Program;
Disproportionate Share
Hospital Payments.
March 26, 2004........................ 15837 ............................................... CMS-9020-N............... Medicare and Medicare
Programs; Quarterly
Listing of Program
Issuances--October 2003
Through December 2003.
March 26, 2004........................ 15835 ............................................... CMS-2183-N............... Funding Opportunity Title:
Medicaid Program; Medicaid
Infrastructure Grant
Program To Support the
Competitive Employment of
People With Disabilities.
March 26, 2004........................ 15755 42 CFR Part 421................................ CMS-1219-P............... Medicare Program; Durable
Medical Equipment Regional
Carrier (DMERC) Service
Areas and Related Matters.
March 26, 2004........................ 15729 42 CFR Parts 410 and 414....................... CMS-1476-CN2............. Medicare Program; Revisions
to Payment Policies Under
the Physician Fee Schedule
for Calendar Year 2004;
Correction.
March 26, 2004........................ 15703 42 CFR Parts 405 and 414....................... CMS-1372-CN.............. Medicare Program; Changes
to the Medicare Payment
for Drugs for Calendar
Year 2004, Correction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum V--National Coverage Determinations [January 2004 Through
March 2004]
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.
National Coverage Determinations
(January 2004 Through March 2004)
------------------------------------------------------------------------
100-03 Title Issue date Effective date
------------------------------------------------------------------------
270.1......... Electrical 03/19/04 07/01/04
Stimulation and
Electromagnetic
Therapy for the
Treatment of Wounds.
20.16......... Cardiac Output 01/23/04 02/23/04
Monitoring by
Thoracic Electrical
Bioimpedance.
160.23........ Current Perception 03/19/04 04/01/04
Threshold/Sensory
Nerve Conduction
Threshold Test.
------------------------------------------------------------------------
------------------------------------------------------------------------
100-04 Title Issue date Effective date
------------------------------------------------------------------------
TR 71......... Clinical Lab Table 01/23/04 04/05/04
Update for April
2004.
------------------------------------------------------------------------
Addendum VI--FDA-Approved Category B IDEs
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
nonexperimental 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 1st quarter, January 2004 Through March 2004.
------------------------------------------------------------------------
IDE Category
------------------------------------------------------------------------
G010093..................................................... B
G020138..................................................... B
G020290..................................................... B
G030194..................................................... B
G030235..................................................... B
G030261..................................................... B
G030263..................................................... B
G030264..................................................... B
G030265..................................................... B
G030267..................................................... B
G030268..................................................... B
G030269..................................................... B
[[Page 35649]]
G040001..................................................... B
G040005..................................................... B
G040007..................................................... B
G040008..................................................... B
G040009..................................................... B
G040012..................................................... B
G040013..................................................... B
G040014..................................................... B
G040016..................................................... B
G040018..................................................... B
G040019..................................................... B
G040021..................................................... B
G040022..................................................... B
G040024..................................................... B
G040025..................................................... B
G040027..................................................... B
G040028..................................................... B
G040029..................................................... B
G040030..................................................... B
G040031..................................................... B
------------------------------------------------------------------------
Addendum VIIApproval 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'')
------------------------------------------------------------------------
OMB number Approved CFR sections
------------------------------------------------------------------------
0938-0008........................... 414.40, 424.32, 424.44
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
0938-0035........................... 407.40
0938-0037........................... 413.20, 413.24
0938-0041........................... 408.6, 408.22
0938-0042........................... 410.40, 424.124
0938-0045........................... 405.711
0938-0046........................... 405.2133
09380050........................... 413.20, 413.24
0938-0062........................... 431.151, 435.1009, 440.220,
440.250, 442.1, 442.10-442.16,
442.30, 442.40, 442.42, 442.100-
442.119, 483.400-483.480,
488.332, 488.400, 498.3-498.5
0938-0065........................... 485.701-485.729
0938-0074........................... 491.1-491.11
0938-0080........................... 406.7, 406.13
0938-0086........................... 420.200-420.206, 455.100-455.106
0938-0101........................... 430.30
0938-0102........................... 413.20, 413.24
0938-0107........................... 413.20, 413.24
0938-0146........................... 431.800, 431.865
0938-0147........................... 431.800-431.865
0938-0151........................... 493.1405, 493.1411, 493.1417,
493.1423, 493.1443, 493.1449,
493.1455, 493.1461, 493.1469,
493.1483, 493.1489
0938-0155........................... 405.2470
0938-0170........................... 493.1269-493.1285
0938-0193........................... 430.10-430.20, 440.167
0938-0202........................... 413.17, 413.20
0938-0214........................... 411.25, 489.2, 489.20
0938-0236........................... 413.20, 413.24
0938-0242........................... 442.30, 488.26
0938-0245........................... 407.10, 407.11
0938-0246........................... 431.800-431.865
0938-0251........................... 406.7
0938-0266........................... 416.41, 416.47, 416.48, 416.83
0938-0267........................... 410.65, 485.56, 485.58, 485.60,
485.64, 485.66
0938-0269........................... 412.116, 412.632, 413.64, 413.350,
484.245
0938-0270........................... 405.376
0938-0272........................... 440.180, 441.300-441.305
0938-0273........................... 485.701-485.729
0938-0279........................... 424.5
0938-0287........................... 447.31
0938-0296........................... 413.170, 413.184
0938-0300........................... 431.800
0938-0301........................... 413.20, 413.24
0938-0302........................... 418.22, 418.24, 418.28, 418.56,
418.58, 418.70, 418.74, 418.83,
418.96, 418.100
0938-0313........................... 418.1-418.405
0938-0328........................... 482.12, 482.13, 482.21, 482.22,
482.27, 482.30, 482.41, 482.43,
482.45, 482.53, 482.56, 482.57,
482.60, 482.61, 482.62, 482.66,
485.618, 485.631
0938-0334........................... 491.9, 491.10
0938-0338........................... 486.104, 486.106, 486.110
0938-0354........................... 441.60
0938-0355........................... 442.30, 488.26
0938-0357........................... 409.40-409.50, 410.36, 410.170,
411.4-411.15, 421.100, 424.22,
484.18, 489.21
0938-0358........................... 412.20-412.30
0938-0359........................... 412.40-412.52
0938-0360........................... 488.60
0938-0365........................... 484.10, 484.11, 484.12, 484.14,
484.16, 484.18, 484.20, 484.36,
484.48, 484.52
0938-0372........................... 414.330
0938-0378........................... 482.60-482.62
0938-0379........................... 488.26, 442.30
0938-0382........................... 488.26, 442.30
0938-0386........................... 405.2100-405.2171
0938-0391........................... 488.18, 488.26, 488.28
0938-0426........................... 476.104, 476.105, 476.116, 476.134
0938-0429........................... 447.53
0938-0443........................... 473.18, 473.34, 473.36, 473.42
0938-0444........................... 1004.40, 1004.50, 1004.60, 1004.70
0938-0445........................... 412.44, 412.46, 431.630, 456.654,
466.71, 466.73, 466.74, 466.78
0938-0447........................... 405.2133
0938-0448........................... 405.2133, 45 CFR 5, 5b; 20 CFR
Parts 401, 422E
0938-0449........................... 440.180, 441.300-441.310
0938-0454........................... 424.20
0938-0456........................... 412.105
0938-0463........................... 413.20, 413.24, 413.106
0938-0467........................... 431.17, 431.306, 435.910, 435.920,
435.940-435.960
0938-0469........................... 417.107, 417.478
0938-0470........................... 417.143, 417.800-417.840, 422.6
0938-0477........................... 412.92
0938-0484........................... 424.123
0938-0501........................... 406.15
0938-0502........................... 433.138
0938-0512........................... 486.304, 486.306, 486.307
0938-0526........................... 475.102, 475.103, 475.104,
475.105, 475.106
0938-0534........................... 410.38, 424.5
0938-0544........................... 493.1-493.2001
0938-0564........................... 411.32
0938-0565........................... 411.20-411.206
0938-0566........................... 411.404, 411.406, 411.408
0938-0573........................... 412.230, 412.256
0938-0578........................... 447.534
0938-0581........................... 493.1-493.2001
0938-0599........................... 493.1-493.2001
0938-0600........................... 405.371, 405.378, 413.20
0938-0610........................... 417.436, 417.801, 422.128, 430.12,
431.20, 431.107, 434.28, 483.10,
484.10, 489.102
0938-0612........................... 493.801, 493.803, 493.1232,
493.1233, 493.1234, 493.1235,
493.1236, 493.1239, 493.1241,
493.1242, 493.1249, 493.1251,
493,1252, 493.1253, 493.1254,
493.1255, 493.1256, 493.1261,
493.1262, 493.1263, 493.1269,
493.1273, 493.1274, 493.1278,
493.1283, 493.1289, 493.1291,
493.1299
0938-0618........................... 433.68, 433.74, 447.272
0938-0653........................... 493.1771, 493.1773, 493.1777
0938-0657........................... 405.2110, 405.2112
0938-0658........................... 405.2110, 405.2112
0938-0667........................... 482.12, 488.18, 489.20, 489.24
0938-0679........................... 410.38
0938-0685........................... 410.32, 410.71, 413.17, 424.57,
424.73, 424.80, 440.30, 484.12
0938-0686........................... 493.551-493.557
0938-0688........................... 486.304, 486.306, 486.307,
486.310, 486.316, 486.318,
486.325
0938-0690........................... 488.4-488.9, 488.201
0938-0691........................... 412.106
0938-0692........................... 466.78, 489.20, 489.27
0938-0701........................... 422.152
0938-0702........................... 45 CFR 146.111, 146.115, 146.117,
146.150, 146.152, 146.160, 46.180
0938-0703........................... 45 CFR 148.120, 148.124, 148.126,
148.128
0938-0714........................... 411.370-411.389
0938-0717........................... 424.57
0938-0721........................... 410.33
0938-0722........................... 422.370-422.378
[[Page 35650]]
0938-0723........................... 421.300-421.318
0938-0730........................... 405.410, 405.430, 405.435,
405.440, 405.445, 405.455,
410.61, 415.110, 424.24
0938-0732........................... 417.126, 417.470
0938-0734........................... 45 CFR 5b
0938-0739........................... 413.337, 413.343, 424.32, 483.20
0938-0742........................... 422.300-422.312
0938-0749........................... 424.57
0938-0753........................... 422.000-422.700
0938-0754........................... 441.152
0938-0758........................... 413.20, 413.24
0938-0760........................... 484 Subpart E, 484.55
0938-0761........................... 484.11, 484.20
0938-0763........................... 422.1-422.10, 422.50-422.80,
422.100-422.132, 422.300-422.312,
422.400-422.404, 422.560-422.622
0938-0768........................... 417.800-417.840
0938-0770........................... 410.2
0938-0778........................... 422.64, 422.111
0938-0779........................... 417.126, 417.470, 422.64, 422.210
0938-0781........................... 411.404-411.406, 484.10
0938-0786........................... 438.352, 438.360, 438.362, 438.364
0938-0787........................... 406.28, 407.27
0938-0790........................... 460.12, 460.22, 460.26, 460.30,
460.32, 460.52, 460.60, 460.70,
460.71, 460.72, 460.74, 460.80,
460.82, 460.98, 460.100, 460.102,
460.104, 460.106, 460.110,
460.112, 460.116, 460.118,
460.120, 460.122, 460.124,
460.132, 460.152, 460.154,
460.156, 460.160, 460.164,
460.168, 460.172, 460.190,
460.196, 460.200, 460.202,
460.204, 460.208, 460.210
0938-0792........................... 491.8, 491.11
0938-0798........................... 413.24, 413.65, 419.42
0938-0802........................... 419.43
0938-0818........................... 410.141, 410.142, 410.143,
410.144, 410.145, 410.146, 414.63
0938-0829........................... 422.620, 422.624, 422.626
0938-0832........................... 489
0938-0833........................... 483.350-483.376
0938-0841........................... 431.636, 457.50, 457.60, 457.70,
457.340, 457.350, 457.431,
457.440, 457.525, 457.560,
457.570, 457.740, 457.750,
457.810, 457.940, 457.945,
457.965, 457.985, 457.1005,
457.1015, 457.1180
0938-0842........................... 412.23, 412.604, 412.606, 412.608,
412.610, 412.614, 412.618,
412.626, 413.64
0938-0846........................... 411.1, 411.350-411.357, 424.22
0938-0857........................... 419
0938-0860........................... 419
0938-0866........................... 45 CFR Part 162
0938-0872........................... 413.337, 483.20
0938-0873........................... 422.152
0938-0874........................... 45 CFR Parts 160 and 162
0938-0878........................... 422
0938-0883........................... 45 CFR Parts 160 and 164
0938-0887........................... 45 CFR 148.316, 148.318, 148.320
0938-0897........................... 412.22, 412.533
0938-0907........................... 412.230, 412.304, 413.65
0938-0910........................... 422.620, 422.624, 422.626
0938-0911........................... 426.400, 426.500
0938-0916........................... 483.16
0938-0920........................... 438.6, 438.8, 438.10, 438.12,
438.50, 438.56, 438.102, 438.114,
438.202, 438.206, 438.207,
438.240, 438.242, 438.404,
438.406, 438.408, 438.410,
438.414, 438.416, 438.710,
438.722, 438.724, 438.810
------------------------------------------------------------------------
[FR Doc. 04-14274 Filed 6-24-04; 8:45 am]
BILLING CODE 4120-01-P