[Federal Register Volume 69, Number 59 (Friday, March 26, 2004)]
[Notices]
[Pages 15837-15850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6350]



[[Page 15837]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9020-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October 2003 Through December 2003

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 October 2003 through December 2003, 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 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 national coverage determinations 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

[[Page 15838]]

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 
(or CIM) 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 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's 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 Manual, Inpatient Hospital Services 
publication, use CMS-Pub. 100-02, Transmittal No. 01.

(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: March 9, 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.

November 2, 1999 (64 FR 59185)
December 7, 1999 (64 FR 68357)

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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 (69 FR 55618)

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.

        Addendum III.--Medicare and Medicaid Manual Instructions
                  [October 2003 through December 2003]
------------------------------------------------------------------------
     Transmittal No.               Manual/Subject/Publication No.
------------------------------------------------------------------------
                     Manual System (CMS-Pub. 100-00)
------------------------------------------------------------------------
01.......................  Introduction.
------------------------------------------------------------------------
                Medicare Benefit Policy (CMS-Pub. 100-02)
------------------------------------------------------------------------
01.......................  Inpatient Hospital Services.
                           Inpatient Psychiatric Hospital Services.
                           Duration of Covered Inpatient Services.
                           Inpatient Psychiatric Benefit Days Reduction
                            and Lifetime Limitation.
                           Lifetime Reserve Days.
                           Hospital Services Covered Under Part B.
                           Home Health Services.
                           Coverage of Extended Care Skilled Nursing
                            Facility Services Under Hospital Coverage of
                            Hospice Services Under Hospital Insurance.
                           Ambulance Services.
                           End-Stage Renal Disease.
                           Comprehensive Outpatient Rehabilitation
                            Facility Coverage.
                           Rural Health Clinic and Federally Qualified
                            Health Center Services.
                           Medical Devices.
                           Covered Medical and Other Health Services.
                           General Exclusions from Coverage.
02.......................  Provider Education Article Stopping Abuse of
                            the Power Wheelchair Benefit.
03.......................  Fecal-Occult Blood Tests.
------------------------------------------------------------------------
       Medicare National Coverage Determinations (CMS-Pub. 100-03)
------------------------------------------------------------------------
02.......................  Artificial Hearts and Related Devices.
03.......................  Lung Volume Reduction Surgery (Reduction
                            Pneumoplasty).
04.......................  Provider Education Article Ventricular Assist
                            Devices for Destination Therapy.
05.......................  Colorectal Cancer Screening Test.
------------------------------------------------------------------------
              Medicare Claims Processing (CMS-Pub. 100-04)
------------------------------------------------------------------------
01.......................  General Billing Requirements.
                           Admission and Registration Requirements.
                           Inpatient Part A Hospital.
                           Part B Hospital (Including Inpatient Hospital
                            Part B and Outpatient Prospective Payment
                            System).
                           Part B Outpatient Rehabilitation and
                            Comprehensive Outpatient Rehabilitation
                            Facility Services.
                           Skilled Nursing Facility Inpatient Part A
                            Billing.
                           Skilled Nursing Facility Part B (Including
                            Inpatient Part B and Outpatient Fee
                            Schedule).
                           Outpatient ESRD Hospital, Independent
                            Facility, and Physician/Supplier Claims.
                           Rural Health Clinics and Federal Qualified
                            Health Centers.
                           Home Health Agency Billing.
                           Hospice.
                           Physician/Practitioner Billing.
                           Radiology Services.
                           Ambulatory Surgical Centers.
                           Ambulance.
                           Laboratory Services from Independent Labs,
                            Physicians, and Providers.
                           Drugs and Biologicals.
                           Preventive and Screening Services.
                           Indian Health Services (not yet available).
                           Durable Medical Equipment, Prosthetics,
                            Orthotics and Supplies Parenteral and
                            Enteral.
                           Medicare Summary Notices.
                           Remittance Notices to Providers.
                           Fee Schedule Administration and Coding
                            Requirements.
                           EDI Support Requirements.
                           Completing and Processing UB-92 (CMS-1450)
                            Data Set.
                           Completing and Processing Form CMS-1500 Data
                            Set.
                           Contractor Instructions for Common Working
                            File.
                           Coordination With Medigap, Medicaid, and
                            Other Complementary Insurers.

[[Page 15840]]

 
                           Appeals of Claims Decisions.
                           Financial Liability Protections.
02.......................  File Descriptions for Retrieving the 2004
                            Pricing and Health Common Coding Data Files
                            through Centers for Medicare & Medicaid
                            Services.
                           Mainframe Telecommunications System.
03.......................  New Effective Data for CR2112 (Revisions to
                            the Outpatient Prospective Payment System
                            Pricer Software and Outpatient Code Editor).
04.......................  October 2003 Update to the Health Care
                            Provider Taxonomy Code.
05.......................  Type of Service.
06.......................  Implementation of the Coding, Testing, and
                            Implementation Phase and Provider Education
                            for Change Request 2631, Revisions to the
                            Medicare.
                           Carrier Manual for Jurisdiction and
                            Unprocessable Claims.
07.......................  Correction of Duplicate Editing in Common
                            Working File for Immunosuppressive Drug
                            Claims at the Durable Medical Equipment
                            Regional Carrier.
08.......................  Annual Update of Healthcare Common Procedure
                            Coding System Codes Used for Home Health
                            Consolidated Billing Enforcement.
09.......................  Reasonable Charge Update for 2004 for
                            Splints, Casts, Dialysis Supplies, Dialysis
                            Equipment, Therapeutic Shoes, and Certain
                            Intraocular Lenses.
10.......................  Billing Instructions for Claims for
                            Ventricular Assist Devices for Beneficiaries
                            in a Medicare+Choice Plan.
11.......................  Use of GY Modifier to Identify Clinical
                            Diagnostic Laboratory Services That Are Not
                            Covered by Medicare.
12.......................  Certificate for Physician-Performed
                            Microscopy Procedures.
13.......................  Confirming Outcome & Assessment Information
                            Set Assessment Items.
                           Therapy Threshold.
                           Hospitalization Within 14 Days of Start Care.
14.......................  Modifier for Transportation of Portable X-
                            rays.
15.......................  Implementation Guide Edits.
16.......................  Payment Limit for Purchased Service.
17.......................  Billing and Payment Procedures Regarding
                            Ownership and Provider Numbers.
                           Payment Procedures for Terminated Home Health
                            Agency.
18.......................  Expansion of Beneficiary History and Claims
                            In Process Files in the Viable Information
                            Processing System Medicare System.
19.......................  Annual Update of Healthcare Common Procedure
                            Coding System Codes Used For Skilled Nursing
                            Facility Consolidated Billing Enforcement.
20.......................  Updated Skilled Nursing Facility to Pay File
                            Available for Download.
21.......................  Update to Medicare Deductible, Coinsurance,
                            and Premium Rates for Calendar Year 2004.
22.......................  Schedule Release for January Updates to
                            Software Programs and Pricing/Coding Files.
23.......................  Claims Information and Claims Forms and
                            Formats.
                           Paper Claim Submission to Carriers.
                           Electronic Claim Submission to Carriers.
24.......................  Billing Non-Covered Charges to Fiscal
                            Intermediaries `` Summary and New
                            Instructions.
25.......................  Billing Non-Covered Charges to Fiscal
                            Intermediaries.
26.......................  Lung Volume Reduction Surgery.
27.......................  CPT Code for Lung Volume Reduction Surgery
                            and Instructions for Processing Claims for
                            Beneficiaries in a Risk Medicare+Choice
                            Plan.
28.......................  Consolidation of the Claims Crossover Process
                            & the Adding of Common Working File.
                           Crossover Disposition Indicators.
29.......................  Consolidation of Claims Crossover.
30.......................  The Financial Limitation.
                           Discipline Specific Outpatient Rehabilitation
                            Modifiers--All Claims.
31.......................  Dialysis Provider Number Series.
32.......................  Remittance Advice Remark Code and Claim
                            Adjustment Reason Code Update.
33.......................  Mammography Quality Standards Act of 1992
                            File.
34.......................  ANSIX12 Transaction 835 Companion Document
                            and Flat File Change for.
                           Durable Medical Equipment Regional Carriers,
                            and Correction in the Companion Document for
                            Fiscal Intermediaries.
35.......................  Minimum Number of Pricing Files that Must be
                            Maintained Online for Single Drug Pricer.
36.......................  Revenue Code 068X.
37.......................  Medicare Physician Fee Schedule Data Base.
38.......................  Revised Skilled Nursing Facility No Pay/File--
                            Effective January 1, 2004.
39.......................  The Supplemental Security Income Medicare
                            Beneficiary Data for Fiscal Year 2002 for
                            Inpatient Rehabilitation Facility Paid Under
                            the Prospective Payment System.
40.......................  Healthcare Common Procedure Coding System and
                            Diagnosis Codes.
                           Roster Claims Submitted to Carriers for Mass
                            Immunization.
                           Claims Submitted to Fiscal Intermediaries for
                            Mass Immunizations of Influenza and
                            Pneumococcal Pneumonia Vaccine.
41.......................  Payment for Anesthesia in a Critical Access
                            Hospital.
42.......................  Financial Limitation on Therapy Services.
43.......................  Displaying Material With CDT-4 Code.
                           American Dental Association's Copyright
                            Notice.
                           Point and Click License, and Shrink Wrap
                            License.
44.......................  Mandatory Electronic Submission of Claims.
                           Small Providers and Full-Time Equivalent
                            Employee Assessments Exceptions.
                           Electronic and Paper Claims Implications Of
                            Mandatory Electronic Submission.
45.......................  Outpatient Provider Specific File.

[[Page 15841]]

 
46.......................  Outpatient Prospective Payment System
                            Outpatient Code Editors.
47.......................  Carriers Specific Requirements for Certain
                            Specialties/Services.
48.......................  National Council for Prescription Drug
                            Programs.
49.......................  Fiscal Intermediaries Health Insurance
                            Portability and Accountability Act.
                           Claim Level Edits.
50.......................  Description of Healthcare Common Procedure
                            Coding System.
51.......................  January Medicare Outpatient Code Editor (OCE)
                            Specifications Version 19.1 For Bills From
                            Hospitals That Are Not Paid Under the
                            Outpatient Prospective Payment System.
52.......................  Colorectal Cancer Screening.
53.......................  January Outpatient Code Editor Specifications
                            Version 5.0.
54.......................  Payment Allowance Limit for Drugs and
                            Biologicals Not Paid on a Cost or
                            Prospective Payment Basis.
55.......................  Calculation of the Payment Allowance Limit
                            for Durable Medical Equipment Regional
                            Carrier Drugs.
56.......................  Ambulance Inflation Factor.
--------------------------
               Medicare Secondary Payer (CMS-Pub. 100-05)
------------------------------------------------------------------------
01.......................  Background and Overview.
                           Medicare Secondary Payer Provisions.
                           Medicare Secondary Providers Billing
                            Requirements.
                           Coordination of Benefits Contractor
                            Requirements.
                           Contractor Prepayment Processing
                            Requirements.
                           Medicare Secondary Payer Common Working File
                            Process.
                           Contractor MSP.
                           Recovery Rules.
02.......................  Individuals Not Subject to the Limitation on
                            Payment.
03.......................  Non-Employer Group Health Plan ``Send to
                            Common Working File''.
                           Switch Error.
04.......................  Data Center Testing Production.
05.......................  Data Center Testing Production.
06.......................  Auto Notice of Change to Medicare Secondary
                            Payer.
                           Medicare Financial Management.
--------------------------
            Medicare Financial Management. (CMS-Pub. 100-06)
------------------------------------------------------------------------
23.......................  Clarification of Existing Instructions to
                            Chapters 1 and 2 of the Medicare Financial
                            Management.
24.......................  Installation of Version 32.0 of the Provider
                            Statistical and Reimbursement Reporting
                            Stem.
25.......................  Initial Interest Rate Manual Instruction and
                            Business Requirement.
26.......................  Incremental Cost Budgeting and Reporting for
                            Productivity Investment Projects.
27.......................  Revision to Chapters 8, 9 and 10 of the
                            Medicare Financial Management Manual.
28.......................  Uncollectible Accounts Forms.
29.......................  Revisions to Chapters 3 and 4.
--------------------------
              Medicare Program Integrity (CMS-Pub. 100-08)
------------------------------------------------------------------------
52.......................  The Report of Benefit Saving.
53.......................  Informing Beneficiaries About Which Local
                            Medical Review Policy and/or National
                            Determination Is Associated With Their
                            Claims Denial.
54.......................  Informing Beneficiaries About Which Lab
                            Negotiated National Coverage.
55.......................  Quarterly Update To Correct Coding Initiative
                            Edit, Version 10.0, Effective January 1,
                            2004.
56.......................  Update of Codes in the Program Integrity
                            Management Reporting System and the
                            Contractor Administrative Cost and Financial
                            Management System.
57.......................  Quarterly Update to Correct Coding Initiative
                            Edits, Version 10.0, Effective January 1,
                            2004.
58.......................  Provider Enrollment Manual Section 20.
59.......................  Documentation Specifications for Areas
                            Selected for Prepayment or Postpayment.
                           Medicare Review.
60.......................  Provider Enrollment, Chain and Ownership
                            System.
--------------------------
  Medicare Contractor Beneficiary and Provider Communications (CMS Pub.
                                 100-09)
------------------------------------------------------------------------
1........................  Contains General Instructions and
                            Requirements for Medicare Carriers,
                            Including Durable Medical Equipment Regional
                            Carrier and Intermediaries, for Processing
                            Correspondence.
2........................  Revised Disclosure Desk Reference for Call
                            Centers (Fourth Version).
3........................  Corrections and Reorganization of Material.
--------------------------
      Medicare Quality Improvement Organizations (CMS-Pub. 100-10)
------------------------------------------------------------------------
11.......................  Medicare+Choice Organizations.
12.......................  Quality Improvement Organization.
13.......................  Hospital Self-Generated Data

[[Page 15842]]

 
Medicare End-Stage Renal Disease Network Organizations (CMS Pub. 100-14)
------------------------------------------------------------------------
4........................  Confidentiality and Disclosure.
--------------------------
                 Medicare Managed Care (CMS Pub. 100-16)
------------------------------------------------------------------------
32.......................  Contacts With Medicare+Choice Organizations.
33.......................  Contacts With Medicare+Choice Organizations.
34.......................  Medicare+Choice Beneficiary Grievances.
35.......................  Contacts With Medicare+Choice Organizations.
36.......................  Medicare+Choice Organizations.
37.......................  Revisions to Chapter 15.
38.......................  Medicare Cost Plan Enrollment and
                            Disenrollment Instructions.
39.......................  Quality Assessment.
40.......................  Manualization of the Plan Communication
                            Guide.
--------------------------
                End-Stage Renal Disease (CMS-Pub. 100-14)
------------------------------------------------------------------------
1........................  Forward.
                           Purpose of the Network Manual.
                           Statutes and Regulations.
                           End-Stage Renal Disease Network Organizations
                            Manual Revisions.
                           Acronyms and Glossary.
                           Purpose of End-Stage Renal Disease Network
                            Organization.
                           Requirements for End-Stage Renal Disease
                            Network Organization.
                           Responsibilities of End-Stage Renal Disease
                            Network Organization.
                           Health Care Quality Improvement Program
                            Goals.
                           Network Organization's Role in Health Care
                            Quality Improvement Program.
2........................  Forward.
                           Purpose of the Network Manual.
                           Statutes and Regulations.
                           Revision to the End-Stage Renal Disease
                            Organizations Manual.
                           Purpose of End-Stage Renal Disease Network
                            Organization.
                           Requirements for End-Stage Renal Disease
                            Network Organizations.
                           Responsibilities of End-Stage Renal Disease
                            Network Organizations Goals.
                           Network Organization's Role in Health Care
                            Quality Improvement Program.
3........................  Organizational Structure.
                           Establishing the Network Computer.
                           Board of Directors.
                           Other Committees.
                           Network Staff.
                           Required Administrative Reports/Activities.
                           Quarterly Progress and Status Reports.
                           Annual Report.
                           Semi Annual Report of Network Operating
                            Costs.
                           New End Stage Renal Disease Patient
                            Orientation Package Activities.
                           Internal Quality Control Program.
                           Internal Quality Control Program
                            Requirements.
--------------------------
                  Managed Care Manual (CMS Pub. 100-16)
------------------------------------------------------------------------
26.......................  Alternate Employer Group Enrollment Election.
                           Optional Employer Group Medicare+Choice
                            Enrollment Election.
                           Request Submitted via Internet.
                           Request Signature and Data.
                           Effective Dates.
                           Notice Requirements.
                           Optional Employer Group Medicare+Choice
                            Disenrollment Election.
                           Medigap-Guaranteed Issue Notification
                            Requirements.
                           General Rule.
                           Effective Date.
                           Researching and Acting on a Change of
                            Address.
                           Clarified the Notice Requirements for Out of
                            Area Permanent.
27.......................  Noncontracted Provider Appeals.
                           Storage of Appeal Case Files by the
                            Independent Review Entity.
                           Representative Filing on Behalf of the
                            Enrollee.
                           Storage of Hearing Files.
28.......................  Streamlined Marketing Review Process.
                           Introduction.
                           Marketing Review Process.
                           Guidelines for Advertising Material.

[[Page 15843]]

 
                           Guidelines for Advertising (Pre-enrollment)
                            Material.
                           Guidelines for Beneficiary Notification
                            Materials.
                           Model Annual Notice of Change.
                           General Guidance on Dual Eligibility.
                           Guideline for Outreach Program.
                           Submission Requirements.
                           Center for Medicare+Medicaid Services Review/
                            Approval Process.
                           Model Direct Mail Letter.
                           Summary of Benefits for Medicare+Choice
                            Organizations.
                           Referral Programs.
                           Allowable Actions for Medicare+Choice
                            Organizations.
                           Specific Guidance About the Use of
                            Independent Insurance Agents.
                           Answers to Frequently Asked Questions About
                            Promotional Marketing of Multiple Lines of
                            Business.
29.......................  Introduction.
                           Quality Assessment and Performance
                            Improvement Program.
                           Administration of the Quality Assessment and
                            Performance Improvement Program.
                           Medicare+Choice Organizations Using Physician
                            Incentive Plans.
                           Health Information System.
                           Quality Assessment and Performance
                            Improvement.
                           Centers for Medicare & Medicaid Services
                            Directed Special Projects.
                           Reporting Time Frames.
                           Communication Process.
                           Quality Assessment and Performance
                            Improvement.
                           Process for Centers for Medicare & Medicaid
                            Services Multi-Year Quality Assessment and
                            Performance Improvement Program Project
                            Approvals.
                           Evaluation of Quality Assessment and
                            Performance Improvement Program Projects.
                           The Medicare+Choice Deeming Program.
                           Terminology.
                           General Rule.
                           Obligations of Deemed Medicare & Medicaid
                            Organizations.
                           Oversight of Accrediting Organizations.
                           Application Requirements.
                           Reporting Requirements.
                           Informal Hearing Procedures.
30.......................  Reasonable Cost-Based Payments--General.
                           Reasonable Cost Payments.
                           Bill Processing.
                           Principles of Payments.
                           Budget and Enrollment Forecast.
                           Interim Per Capita Rate.
                           Interim Payment for Health Care Prepayment
                            Plans.
                           Electronic Transfer of Funds.
                           Payment Report.
                           Interim and Final Cost and Enrollment Report.
                           Adjustment of Payments.
                           Final Cost Report.
                           Final Settlement Process for Medicare Health
                            Care Prepayment Plans.
                           Final Settlement Payment for Medicare Health
                            Care Prepayment Plans.
                           Recovery of Overpayment.
                           Interest Charges for Medicare Overpayments/
                            Underpayments.
                           The Basic Rules.
                           Definition of Final Determination.
                           Rate of Interest.
                           Accrual of Interest.
                           Waiver of Interest.
                           Rules Applicable to Partial Payments.
                           Exception to Applicability.
                           Nonallowable Interest Cost.
                           Centers for Medicare & Medicaid Services
                            General Payment Principles.
                           Medicare Payments to Health Care Prepayment
                            Plans.
                           Prudent Buyer Principle.
                           Allowable Costs.
                           Costs Not Reimbursable Directly to the Health
                            Care Prepayment Plans.
                           Deductible and Coinsurance.
                           Hospice Care Costs.
                           Medicare as Secondary Payer.
31.......................  Overview of Enrollment and Payment Process.
                           Purpose of the Chapter.
                           Medicare+Choice Organization Data Processing
                            Responsibilities.
                           Centers for Medicare & Medicaid Services
                            Group Health Plan System.
                           Enrollment/Disenrollment Requirements and
                            Effective Dates.

[[Page 15844]]

 
                           General.
                           Enrollments.
                           Disenrollments.
                           Cost Based Medicare+Choice Organizations
                            Only.
                           Medicare+Choice Organizations Only.
                           Cost Based Medicare+Choice Organizations
                            Only--Employer Group Health Plan.
                           Retroactive Enrollment.
                           Medicare Membership Information.
                           The Centers for Medicare & Medicaid Services
                            Medicare+Choice.
                           Organizations Only Interface.
                           Submitting Medicare Membership Information to
                            Centers for Medicare & Medicaid Services.
                           Submission of Enrollment/Disenrollment
                            Transaction Records.
                           Submission of Correction Transaction Records.
                           Health Insurance Claim Number.
                           Transaction Type Code and the Prior
                            Commercial Indicator.
                           Transaction Type Codes.
                           Prior Commercial Months Field.
                           Special Status Beneficiaries--Medicare+Choice
                            Organizations.
                           Special Status Beneficiaries.
                           Special Status--Hospice.
                           Special Status--End-Stage Renal Disease.
                           Special Status--Institutionalized.
                           Special Status--Medicaid/Medical Assistance
                            Only.
                           Special Status--Working Aged.
                           When to Submit ``Special Status'' Information
                            (Medicare+Choice Organizations Only).
                           Other Medicare Membership Information.
                           Risk Adjustment Payment.
                           Bonus Payment.
                           Extra Payment in Recognition of Quality
                            Congestive Heart Failure.
                           Outpatient Care.
                           Benefit Stabilization Fund.
                           Electronic Submission of Membership Records
                            to Centers for Medicare & Medicaid Services.
                           Timeliness Requirements.
                           Record Submission Schedule.
                           Sending the Transaction File to Centers for
                            Medicare & Medicaid Services.
                           Electronic Data Transfer.
                           Centers for Medicare & Medicaid Services Data
                            Center Access.
                           Data Processing Vendor.
                           Receiving Medicare Membership Information
                            From Centers for Medicare & Medicaid
                            Services.
                           General.
                           Centers for Medicare & Medicaid Services
                            Transaction Reply/Monthly Activity Report.
                           Transaction Reply Field Information.
                           Plan Payment Report.
                           Demographic Report-Medicare+Choice
                            Organizations Only.
                           Medicare Fee-For-Service Bill Itemization and
                            Summary Report.
                           Monthly Membership Report.
                           Bonus Payment Report.
                           Working Aged Transaction Status Report.
                           Retroactive Payment Adjustment Policy.
                           Standard Operating Procedures for State and
                            County Code Adjustments.
                           Standard Operating Procedures for Processing
                            of Institutional Adjustments.
                           Standard Operating Procedures for Medicaid
                            Retroactive Adjustments.
                           Standard Operating Procedures for End-Stage
                            Renal Disease Retroactive Adjustments.
                           Processing of Working Aged Retroactive
                            Adjustments.
                           Standard Operating Procedures for Retroactive
                            Adjustment Plan Elections.
                           Centers for Medicare & Medicaid Services,
                            Social Security Act.
                           Administration, and Customer Service Center
                            Disenrollments.
                           General.
                           Medicare Customer Service Center
                            Disenrollments.
                           Centers for Medicare & Medicaid Services
                            Disenrollments.
                           Coordination With the Medicare Fee-For-
                            Services Program.
                           Pro-Rate Deductible.
                           Duplicate Payment Prevention by Cost-Based
                            Medicare+Choice Organizations.
--------------------------
                 One Time Notification (CMS Pub. 100-20)
------------------------------------------------------------------------
06.......................  Either Impact Multiple Manuals or Have No
                            Manual Impact.
07.......................  Common Working File Edits for Inserts for
                            Therapeutic Shoes.
08.......................  Revised X12N 4010A1 837 Professional Flat
                            File.
09.......................  Shared System Maintainer Hours for Resolution
                            of Problems Detected During Health Insurance
                            Portability and Accountability Act
                            Transaction Release Testing.

[[Page 15845]]

 
10.......................  Changes to the Laboratory National Coverage
                            Determination Edit Software for January 1,
                            2004.
11.......................  Calendar Year 2004 Participation Enrollment
                            and Medicare Participating Physicians and
                            Suppliers Directory Procedures.
12.......................  New Waived Tests--January 1, 2004.
13.......................  Program Integrity Management Reporting System
                            for Part A--Phase 3.
14.......................  Comprehensive Error Rate Testing Program--
                            Requirements Update for Medicare Part A
                            Provider Address File and Sample Claims
                            Resolution File.
15.......................  Changes in Transitional Outpatient Payment
                            (TOP) for 2004.
16.......................  Implementation of Correction to: Changes to
                            the Hospital Inpatient Prospective Payment
                            System and Fiscal Year 2004 Rates; as
                            Published in the October 6, 2003, Federal
                            Register (68 FR 57732); and Extension of the
                            Provision Equalizing the Urban and Rural
                            Standardized Medicare Inpatient Hospital
                            Payments as Required by Public Law 108-89.
17.......................  Fee Schedule Update for 2004 for Durable
                            Medical Equipment, Prosthetics, Orthotics,
                            and Supplies.
18.......................  Change in Coding on Medicare Claims for
                            Darbepoetin Alfa (Trade Name Aranesp) and
                            Epoetin Alfa (Trade Name Epogen) of
                            Treatment of Anemia in End-Stage Renal
                            Disease Patients on Dialysis.
19.......................  Change in Payment for Darbepoetin Alfa (Trade
                            Name Aranesp) for Treatment of Anemia In End-
                            Stage Renal Disease Patients on Dialysis.
20.......................  2004 Annual Update for Clinical Laboratory
                            Fee Schedule and Laboratory Services to
                            Reasonable Charge Payment.
21.......................  Indian Health Service (IHS) Hospital Payment
                            Rates for Calendar Year 2003.
22.......................  Clarification to Transmittal B-03-059 (CR
                            2755)--Minimum Number of Pricing Files That
                            Must Be Maintained Online for Medicare
                            Single Drug Pricer.
23.......................  Payment for Ambulance Services Furnished by
                            New Suppliers.
24.......................  Instructions for Fiscal Intermediary Standard
                            System (FISS) and Multi-Carrier System
                            Healthcare Integrated General Ledger
                            Accounting System Changes.
25.......................  Clarification of Mammography Annual Screening
                            Examination.
26.......................  Coding and Billing Instructions for VelcadeTM
                            (Bortezomib).
27.......................  Emergency Correction to the 2004 Healthcare
                            Common Procedure Coding System File.
28.......................  2004 Medicare Physician Fee Schedule Increase
                            and Extension of the Annual Participation
                            Enrollment Period.
29.......................  Revised American National Standards Institute
                            X12N 837 Professional Health Care Claim
                            Companion Document.
30.......................  Changes in Transitional Outpatient Payment
                            (TOP) for 2004.
31.......................  Emergency Revised 2004 Update of the Durable
                            Medical Equipment Provider of Services and
                            Clinical Laboratory Fee Schedules.
32.......................  January 2004 Update of the Hospital
                            Outpatient Prospective Payment System.
33.......................  Change of Medicare Part A Plan Under Contract
                            With the Blue Cross/Blue Shield Association
                            and Change of Part B Carrier in the State of
                            Rhode Island From Blue Cross/Blue Shield of
                            Rhode Island to Arkansas Blue Cross/Blue
                            Shield.
34.......................  2004 Medicare Physician Fee Schedule Annual
                            Changes.
35.......................  Emergency Correction to the Fee Schedule
                            Update for 2004 for Durable Medical
                            Equipment, Prosthetics, Orthotics, and
                            Supplies
36.......................  Additional Modification Regarding Change
                            Request 2963: Change in Coding on Medicare
                            Claims for Darbepoetin Alfa (Trade Name
                            Aranesp) and Epoetin Alfa (Trade Name
                            Epogen) for Treatment of Anemia In End-Stage
                            Renal Disease Patient on Dialysis.
37.......................  Home Health Cost Reporting Processes.
------------------------------------------------------------------------


                                          Addendum IV.--Regulation Documents Published in the Federal Register
                                                          [October 2003 through December 2003]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      FR Vol. 68
          Publication date             page no.               CFR parts affected                        File code                Title of regulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 6, 2003....................        57732  42 CFR Parts 412 and 413..................  CMS-1470-CN                   Medicare Program; Changes to
                                                                                                                             the Hospital Inpatient
                                                                                                                             Prospective Payment Systems
                                                                                                                             and Fiscal Year 2004 Rates;
                                                                                                                             Correction.
October 10, 2003...................        58756  42 CFR Parts 409, 411, 413, 440, 483, 488,  CMS-1469-CN                   Medicare Program;
                                                   and 489.                                                                  Prospective Payment System
                                                                                                                             and Consolidated Billing
                                                                                                                             for Skilled Nursing
                                                                                                                             Facilities; Correction.
October 24, 2003...................        61005  ..........................................  CMS-1253-N                    Medicare Program; November
                                                                                                                             17, 2003, Meeting of the
                                                                                                                             Practicing Physicians
                                                                                                                             Advisory Council.
October 24, 2003...................        61004  ..........................................  CMS-4061-N                    Medicare Program: Meeting of
                                                                                                                             the Advisory Panel on
                                                                                                                             Medicare Education-November
                                                                                                                             20, 2003.
October 24, 2003...................        61002  ..........................................  CMS-8018-N                    Medicare Program; Part A
                                                                                                                             Premium for 2004 for the
                                                                                                                             Uninsured Aged and for
                                                                                                                             Certain Disabled
                                                                                                                             Individuals Who Have
                                                                                                                             Exhausted Other
                                                                                                                             Entitlement.
October 24, 2003...................        60997  ..........................................  CMS-8017-N                    Medicare Program; Monthly
                                                                                                                             Actuarial Rates and Monthly
                                                                                                                             Supplementary Medical
                                                                                                                             Insurance Premium Beginning
                                                                                                                             January 1, 2004.
October 24, 2003...................        60995  ..........................................  CMS-8016-N                    Medicare Program; Inpatient
                                                                                                                             Hospital Deductible and
                                                                                                                             Hospital and Extended Care
                                                                                                                             Services Coinsurance
                                                                                                                             Amounts for 2004.
November 7, 2003...................        63398  42 CFR Parts 410 and 4419.................  CMS-1471-FC                   Medicare Program; Changes to
                                                                                                                             the Hospital Outpatient
                                                                                                                             Prospective Payment System
                                                                                                                             and Calendar Year 2004
                                                                                                                             Payment Rates.

[[Page 15846]]

 
November 7, 2003...................        63692  42 CFR Parts 400, 405, and 426............  CMS-3063-F                    Medicare Program: Review of
                                                                                                                             National Coverage
                                                                                                                             Determinations and Local
                                                                                                                             Coverage Determinations.
November 7, 2003...................        63196  42 CFR Parts 410, and 414.................  CMS-1476-FC                   Medicare Program; Revisions
                                                                                                                             to Payment Policies Under
                                                                                                                             the Physician Fee Schedule
                                                                                                                             for Calendar Year 2004.
November 19, 2003..................        65346  42 CFR Part 426...........................  OFR Correction                Medicare Program; Review of
                                                                                                                             National Coverage
                                                                                                                             Determinations and Local
                                                                                                                             Coverage Determinations.
November 28, 2003..................        66920  42 CFR Parts 412, 413, and 424............  CMS-1213-P                    Medicare Program;
                                                                                                                             Prospective Payment System
                                                                                                                             for Inpatient Psychiatric
                                                                                                                             Facilities.
November 28, 2003..................        66721  42 CFR Part 408...........................  CMS-6016-F                    Medicare Program; Reduction
                                                                                                                             in Medicare Part B Premiums
                                                                                                                             as Additional Benefits
                                                                                                                             Under Medicare+Choice
                                                                                                                             Plans.
November 28, 2003..................        66710  42 CFR Parts 403, 489, and 498............  CMS-1909-F                    Medicare Program; Religious
                                                                                                                             Nonmedical Health Care
                                                                                                                             Institutions and Advance
                                                                                                                             Directives.
December 5, 2003...................        67960  42 CFR Part 414...........................  CMS-1232-FC                   Medicare Program; Coverage
                                                                                                                             and Payment of Ambulance
                                                                                                                             Services; Inflation Update
                                                                                                                             for CY 2004.
December 5, 2003...................        67955  42 CFR Parts 412, 413, 476, and 484.......  CMS-3055-F                    Medicare Program;
                                                                                                                             Photocopying Reimbursement
                                                                                                                             Methodology.
December 15, 2003..................        69928  ..........................................  CMS-4063-N                    Medicare Program; Medicare
                                                                                                                             Prescription Drug Discount
                                                                                                                             Card.
December 15, 2003..................        69840  42 CFR Parts 403 and 408..................  CMS-4063-IFC                  Medicare Program,
                                                                                                                             Prescription Drug Discount
                                                                                                                             Card.
December 15, 2003..................        69707  ..........................................  CMS 1370-N                    Medicare Program; The
                                                                                                                             Practicing Physicians
                                                                                                                             Advisory Council's Request
                                                                                                                             for Nominations.
December 24, 2003..................        74792  42 CFR Parts 405 and 491..................  CMS-1910-F                    Medicare Program; Rural
                                                                                                                             Health Clinics: Amendments
                                                                                                                             to Participation
                                                                                                                             Requirements and Payment
                                                                                                                             Provisions; and
                                                                                                                             Establishment of a Quality
                                                                                                                             Assessment and Performance
                                                                                                                             Improvement Program.
December 24, 2003..................        74622  ..........................................  CMS-1247-N                    Medicare Program; Town Hall
                                                                                                                             Meeting in Calendar Year
                                                                                                                             2004 for Ambulance
                                                                                                                             Condition Codes.
December 24, 2003..................        74621  ..........................................  CMS-1254-N                    Medicare Program, Meeting of
                                                                                                                             the Advisory Panel on
                                                                                                                             Ambulatory Payment
                                                                                                                             Classification Groups--
                                                                                                                             February 18, 19, and 20,
                                                                                                                             2004.
December 24, 2003..................        74613  ..........................................  CMS-1226-GNC                  Medicare Program; Criteria
                                                                                                                             and Standards for
                                                                                                                             Evaluating Intermediary,
                                                                                                                             Carrier, and Durable
                                                                                                                             Medical Equipment,
                                                                                                                             Prosthetics, Orthotics, and
                                                                                                                             Supplies (DMEPOS) Regional
                                                                                                                             Carrier Performance During
                                                                                                                             Fiscal Year 2004.
December 24, 2003..................        74607  ..........................................  CMS-3119-PN                   Medicare Program; Procedures
                                                                                                                             for Maintaining Code Lists
                                                                                                                             in the Negotiated National
                                                                                                                             Coverage Determinations for
                                                                                                                             Clinical Diagnostic
                                                                                                                             Laboratory Services.
December 24, 2003..................        74590  ..........................................  CMS-9019-N                    Medicare and Medicaid
                                                                                                                             Programs; Quarterly Listing
                                                                                                                             of Program Issuances--July
                                                                                                                             2003 Through September
                                                                                                                             2003.
December 24, 2003..................        74491  42 CFR Part 411...........................  CMS-18089-F4                  Medicare and Medicaid
                                                                                                                             Programs; Physicians'
                                                                                                                             Referrals to Health Care
                                                                                                                             Entities With Which They
                                                                                                                             Have Financial
                                                                                                                             Relationships: Extension of
                                                                                                                             Partial Delay of Effective
                                                                                                                             Date.
December 31, 2003..................        75442  42 CFR Parts 410 and 419..................  CMS-1471-CN                   Medicare Program; Changes to
                                                                                                                             the Hospital Outpatient
                                                                                                                             Prospective Payment System
                                                                                                                             and Calendar Year 2004
                                                                                                                             Payment Rates; Final Rule;
                                                                                                                             Correction.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Addendum V--National Coverage Determinations [October 2003 Through 
December 2003]

    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 (or CIM) 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 15847]]



                                        National Coverage Determinations
                                      [October 2003 Through December 2003]
----------------------------------------------------------------------------------------------------------------
                 100-03                                 Title                    Issue date      Effective date
----------------------------------------------------------------------------------------------------------------
20.9...................................  Ventricular Assist Devices (VADs)..          10/17/03          10/01/03
240.1..................................  Lung Volume Reduction Surgery                11/04/03          10/01/03
                                          (LVRS).
210.3..................................  Fecal Occult Blood Tests (FOBT)....          12/19/03          01/01/04
----------------------------------------------------------------------------------------------------------------


                                        Medicare Claims Processing Manual
----------------------------------------------------------------------------------------------------------------
                 100-04                                 Title                    Issue date      Effective date
----------------------------------------------------------------------------------------------------------------
AB03-104...............................  Changes to the Laboratory NCD Edit           10/24/03          01/01/04
                                          Software for 01/01/04.
----------------------------------------------------------------------------------------------------------------


                                              One-Time Notification
----------------------------------------------------------------------------------------------------------------
                 100-20                                 Title                    Issue date      Effective date
----------------------------------------------------------------------------------------------------------------
AB03-127...............................  2004 Annual Update for Clinical Lab          11/07/03          01/01/04
                                          Fee Schedule.
----------------------------------------------------------------------------------------------------------------

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 4th quarter, October through December 2003.
G020078
G020185
G020237
G030132
G030149
G030156
G030161
G030178
G030180
G030182
G030185
G030186
G030187
G030189
G030190
G030191
G030195
G030197
G030198
G030200
G030201
G030202
G030204
G030205
G030206
G030207
G030208
G030209
G030210
G030214
G030216
G030217
G030219
G030220
G030221
G030222
G030224
G030225
G030226
G030229
G030230
G030232
G030236
G030238
G030239
G030240
G030246
G030248
G030249
G030250
G030255
G030259
G939227

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:

------------------------------------------------------------------------
                               Approved CFR Sections in Title 42, Title
                              45, and Title 20 (Note: Sections in Title
      OMB Control No.        45 are preceded by ``45 CFR,'' and sections
                               in Title 20 are preceded by ``20 CFR'')
------------------------------------------------------------------------
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
0938-0034..................  405.821
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
0938-0050..................  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

[[Page 15848]]

 
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..................  416.44, 418.100, 482.41, 483.270, 483.470
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
0938-0338..................  486.104, 486.106, 486.110
0938-0354..................  441.60
0938-0355..................  484.10-484.52
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..................  405.2100-405.2184
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..................  442.30, 488.26
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
0938-0449..................  440.180, 441.300-441.310
0938-0454..................  424.20
0938-0456..................  412.105
0938-0463..................  413.20, 413.24
0938-0465..................  411.404, 411.406, 411.408
0938-0467..................  431.17, 431.306, 435.910, 435.920, 435.940-
                              435.960
0938-0469..................  417.107, 417.478
0938-0470..................  417.143, 417.408, 417.800-417.840, 422.6
0938-0477..................  412.92
0938-0484..................  424.123
0938-0486..................  498.40-498.95
0938-0501..................  406.15
0938-0502..................  433.138
0938-0512..................  486.301-486.325
0938-0526..................  462.102, 462.103, 475.100, 475.106, 475.107
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
0938-0567..................  Part 498 Subparts D and E, and 20 CFR
                              404.933
0938-0573..................  412.230, 412.256

[[Page 15849]]

 
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..................  493.1-493.2001
0938-0618..................  433.68, 433.74, 447.272
0938-0653..................  493.1771, 493.1773, 493.1777
0938-0655..................  493.1840
0938-0657..................  405.2110, 405.2112
0938-0658..................  405.2110, 405.2112
0938-0667..................  482.12, 488.18, 489.20, 489.24
0938-0673..................  430.10
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..................  486.301-486.325
0938-0690..................  488.4-488.9, 488.201
0938-0691..................  412.106
0938-0692..................  466.78, 489.20, 489.27
0938-0700..................  417.479, 417.500; 422.208, 422.210; 434.44,
                              434.67, 434.70; 1003.100, 1003.101,
                              1003.103, 1003.106
0938-0701..................  422.152
0938-0702..................  45 CFR 146.111, 146.115, 146.117, 146.150,
                              146.152, 146.160, 146.180
0938-0703..................  45 CFR 148.120, 148.124, 148.126, and
                              148.128
0938-0714..................  411.370-411.389
0938-0717..................  424.57
0938-0721..................  410.33
0938-0722..................  422.370-422.378
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..................  Part 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, 422.560-422.622
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..................  491.3, 491.8, 491.11
0938-0798..................  413.24, 413.65, 419.42
0938-0802..................  419.43
0938-0810..................  482.45
0938-0819..................  45 CFR 146.121
0938-0823..................  420.410
0938-0824..................  440.10, 482.13
0938-0827..................  45 CFR 146.141
0938-0829..................  422.568
0938-0832..................  Part 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, 413
0938-0846..................  411.1, 411.350-411.357, 424.22
0938-0857..................  Part 419
0938-0860..................  Part 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..................  Part 422 Subparts F and G

[[Page 15850]]

 
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..................  412.30, 412.304, 413.65
0938-0913..................  414.707
------------------------------------------------------------------------

[FR Doc. 04-6350 Filed 3-25-04; 8:45 am]
BILLING CODE 4120-01-P