[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57312-57324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21202]



[[Page 57312]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9023-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April 2004 Through June 2004

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice lists CMS manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published from April 2004 through June 2004, relating to the Medicare 
and Medicaid programs. This notice provides information on national 
coverage determinations (NCDs) affecting specific medical and health 
care services under Medicare. Additionally, this notice identifies 
certain devices with investigational device exemption (IDE) numbers 
approved by the Food and Drug Administration (FDA) that potentially may 
be covered under Medicare. 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 Medicare NCDs in Addendum V may be addressed 
to Patricia Brocato-Simons, Office of Clinical Standards and Quality, 
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.
    Questions concerning FDA-approved Category B IDE numbers listed in 
Addendum VI may be addressed to 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 
Margaret Teeters, Office of Strategic Operations and Regulatory 
Affairs, Regulations Development Group, Centers for Medicare & Medicaid 
Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-4678.

SUPPLEMENTARY INFORMATION: 

I. Program Issuances

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs. These programs 
pay for health care and related services for 39 million Medicare 
beneficiaries and 35 million Medicaid recipients. Administration of the 
two programs involves (1) furnishing information to Medicare 
beneficiaries and Medicaid recipients, health care providers, and the 
public and (2) maintaining effective communications with regional 
offices, State governments, State Medicaid agencies, State survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, and others. To implement the various 
statutes on which the programs are based, we issue regulations under 
the authority granted to the Secretary of the Department of Health and 
Human Services under sections 1102, 1871, 1902, and related provisions 
of the Social Security Act (the Act). We also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish a list of 
all Medicare manual instructions, interpretive rules, statements of 
policy, and guidelines of general applicability not issued as 
regulations at least every 3 months in the Federal Register. We 
published our first notice June 9, 1988 (53 FR 21730). Although we are 
not mandated to do so by statute, for the sake of completeness of the 
listing of operational and policy statements, and to foster more open 
and transparent collaboration, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the respective 3-month time frame.

II. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of manual issuances, memoranda, substantive and interpretive 
regulations, NCDs, and FDA-approved IDEs published during the subject 
quarter to determine whether any are of particular interest. We expect 
this notice to be used in concert with previously published notices. 
Those unfamiliar with a description of our Medicare manuals may wish to 
review Table I of our first three notices (53 FR 21730, 53 FR 36891, 
and 53 FR 50577) published in 1988, and the notice published March 31, 
1993 (58 FR 16837). Those desiring information on the Medicare NCD 
Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may 
wish to review the August 21, 1989, publication (54 FR 34555). Those 
interested in the revised process used in making NCDs under the 
Medicare program may review the September 26, 2003, publication (68 FR 
55634).
    To aid the reader, we have organized and divided this current 
listing into six addenda:
     Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
     Addendum II identifies previous Federal Register documents 
that contain a description of all previously published CMS Medicare and 
Medicaid manuals and memoranda.
     Addendum III lists a unique CMS transmittal number for 
each instruction in our manuals or Program Memoranda and its subject 
matter. A transmittal may consist of a single or multiple 
instruction(s). Often, it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
     Addendum IV lists all substantive and interpretive 
Medicare and Medicaid

[[Page 57313]]

regulations and general notices published in the Federal Register 
during the quarter covered by this notice. For each item, we list the--
     Date published;
     Federal Register citation;
     Parts of the Code of Federal Regulations (CFR) that have 
changed (if applicable);
     Agency file code number; and
     Title of the regulation.
     Addendum V includes completed NCDs, or reconsiderations of 
completed NCDs, from the quarter covered by this notice. Completed 
decisions are identified by the section of the NCDM in which the 
decision appears, the title, the date the publication was issued, and 
the effective date of the decision.
     Addendum VI includes listings of the FDA-approved IDE 
categorizations, using the IDE numbers the FDA assigns. The listings 
are organized according to the categories to which the device numbers 
are assigned (that is, Category A or Category B), and identified by the 
IDE number.
     Addendum VII includes listings of all approval numbers 
from the Office of Management and Budget (OMB) for collections of 
information in CMS regulations in title 42; title 45, subchapter C; and 
title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

    Those wishing to subscribe to program manuals should contact either 
the Government Printing Office (GPO) or the National Technical 
Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New 
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825 
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell. 
Additionally, most manuals are available at the following Internet 
address: http://cms.hhs.gov/manuals/default.asp.

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both text and graphics from Volume 59, Number 1 (January 2, 1994) 
forward. Free public access is available on a Wide Area Information 
Server (WAIS) through the Internet and via asynchronous dial-in. 
Internet users can access the database by using the World Wide Web; the 
Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html, by using local WAIS client software, 
or by telnet to swais.gpoaccess.gov, then log in as guest (no password 
required). Dial-in users should use communications software and modem 
to call (202) 512-1661; type swais, then log in as guest (no password 
required).

C. Rulings

    We publish rulings on an infrequent basis. Interested individuals 
can obtain copies from the nearest CMS Regional Office or review them 
at the nearest regional depository library. We have, on occasion, 
published rulings in the Federal Register. Rulings, beginning with 
those released in 1995, are available online, through the CMS Home 
Page. The Internet address is http://cms.hhs.gov/rulings.

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

    Our laws, regulations, and manuals are also available on CD-ROM and 
may be purchased from GPO or NTIS on a subscription or single copy 
basis. The Superintendent of Documents list ID is HCLRM, and the stock 
number is 717-139-00000-3. The following material is on the CD-ROM 
disk:
     Titles XI, XVIII, and XIX of the Act.
     CMS-related regulations.
     CMS manuals and monthly revisions.
     CMS program memoranda.
    The titles of the Compilation of the Social Security Laws are 
current as of January 1, 1999. (Updated titles of the Social Security 
Laws are available on the Internet at http://www.ssa.gov/OP_Home/ssact/comp-toc.htm.) The remaining portions of CD-ROM are updated on a 
monthly basis.
    Because of complaints about the unreadability of the Appendices 
(Interpretive Guidelines) in the State Operations Manual (SOM), as of 
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future and, with the aid of newer 
technology, we may again be able to include the appendices on CD-ROM.
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the 
reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 1,400 designated libraries 
throughout the United States. Some FDLs may have arrangements to 
transfer material to a local library not designated as an FDL. Contact 
any library to locate the nearest FDL.
    In addition, individuals may contact regional depository libraries 
that receive and retain at least one copy of most Federal Government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library.
    For each CMS publication listed in Addendum III, CMS publication 
and transmittal numbers are shown. To help FDLs locate the materials, 
use the CMS publication and transmittal numbers. For example, to find 
the Medicare Benefit Policy publication titled ``Arrangements for 
Physical, Occupational, and Speech Language Pathology Services,'' use 
CMS-Pub. 100-02, Transmittal No. 09.

(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: September 7, 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.

May 30, 2000 (65 FR 34481)
June 28, 2002 (67 FR 43762)

[[Page 57314]]

September 27, 2002 (67 FR 61130)
December 27, 2002 (67 FR 79109)
March 28, 2003 (68 FR 15196)
June 27, 2003 (68 FR 38359)
September 26, 2003 (68 FR 55618)
December 24, 2003 (68 FR 74590)
March 26, 2004 (69 FR 15837)
June 25, 2004 (69 FR 35634)

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
                        [April through June 2004]
------------------------------------------------------------------------
                                             Manual/subject/publication
              Transmittal No.                            No.
------------------------------------------------------------------------
             Medicare General Information (CMS--Pub. 100-01)
------------------------------------------------------------------------
04........................................  Scheduled Release for April
                                             Updates to Software and
                                             Pricing/Codes Files.
05........................................  Release of Software.
06........................................  Shared System Maintainer and
                                             Medicare Contractor
                                             Responsibilities for System
                                             Release.
                                            Shared System Testing
                                             Requirements for
                                             Maintainers, Beta Testers,
                                             and Contractors.
                                            Maintainers and Beta
                                             Testers--Required Levels of
                                             Testing.
                                            Minimum Testing Standards
                                             for Maintainers and Beta
                                             Testers.
                                            Testing Standards Applicable
                                             to All Beta Testers.
                                            Testing Requirements
                                             Applicable to the Common
                                             Working File Data Centers.
                                            Timeframe Requirements for
                                             All Testing Entities.
                                            Testing Documentation
                                             Requirements.
                                            Definitions.
                                            Test Care Specification
                                             Standard.
07........................................  The Health Insurance
                                             Portability and
                                             Accountability Act Privacy
                                             Rule.
-------------------------------------------
               Medicare Benefit Policy (CMS--Pub. 100-02)
------------------------------------------------------------------------
09........................................  Arrangements for Physical,
                                             Occupational, and Speech
                                             Language Pathology
                                             Services.
10........................................  Chapter 6.
                                            General Partial
                                             Hospitalization Services.
11........................................  Nurse Practitioner as
                                             Attending Physician in
                                             Hospice.
                                            Requirements--General.
                                            Timing and Content of
                                             Certification.
                                            Election by Health
                                             Maintenance Organization
                                             Enrollees.
                                            Benefit Coverage.
                                            Nursing Care.
                                            Physicians' Services.
                                            Short-Term Inpatient Care.
                                            Continuous Home Care.
                                            Contracting With Physicians.
12........................................  New Requirements for
                                             Chiropractic Billing of
                                             Active/Corrective Treatment
                                             and Maintenance Therapy.
                                            Chiropractor's Services.
                                            Necessity for Treatment.
                                            Treatment Parameters.
13........................................  Diabetes Self-Management
                                             Training Services.
                                            Coverage Requirements.
                                            Certified Providers.
                                            Coding and Frequency of
                                             Training.
                                            Payment for Diabetes Self-
                                             Management Training.
                                            Incident-To Provision.
                                            Bill Processing Requiring.
                                            Special Claims Processing
                                             Instructions for Fiscal
                                             Intermediaries.
14........................................  Changes in the Medicare
                                             Benefit Policy Manual--
                                             Chapter 10.
                                            The Destination.
                                            Institution to Institution.
                                            Separately Payable Ambulance
                                             Transport Under Part B
                                             Versus Patient.
                                            Transportation That Is
                                             Covered Under a Packaged
                                             Institutional Services.
                                            Transports to and From
                                             Medical Services for
                                             Beneficiaries Who Are Not
                                             Inpatients.
                                            Multiple Patient Ambulance
                                             Transport.
15........................................  Chapter 9.
                                            Requirements--General.
                                            Timing and Content of
                                             Content of Certification.
                                            Election by Health
                                             Maintenance Organization
                                             Enrollees.
                                            Benefit Coverage.
                                            Nursing Care.
                                            Physicians' Services.
16........................................  Confidential.
17........................................  Incident-To Services on Form
                                             CMS-1500.
                                            Incident to Physician's
                                             Professional Services.
                                            Incident to Physician's
                                             Service In Clinic.
-------------------------------------------

[[Page 57315]]

 
      Medicare National Coverage Determinations (CMS--Pub. 100-03)
------------------------------------------------------------------------
09........................................  NCD--Ocular Photodynamic
                                             Therapy with Verteporfin
                                             for Age-Related Macular
                                             Degeneration.
10........................................  Chapter 1--NCD Manual.
11........................................  Reconsideration of NCD for
                                             Acupuncture.
11........................................  Acupuncture for
                                             Fibromyalgia.
                                            Acupuncture for
                                             Osteoarthritis
13........................................  Removal of Coding From NCD
                                             on Stem Cell
                                             Transplantation.
                                            Stem Cell Transplantation.
14........................................  NCD--Arthroscopic Lavage and
                                             Arthroscopic Debridement
                                             for the Osteoarthritic
                                             Knee.
15........................................  Reconsideration of NCD for
                                             Sensory Nerve Conduction
                                             Threshold Test (Note that
                                             Change Request CR 3339
                                             constitutes a technical
                                             correction to previously
                                             issued CR 2988 dated 03/19/
                                             04. CR 2988 should be
                                             discarded and replaced with
                                             3339).
                                            Sensory Nerve Conduction
                                             Threshold Test.
16........................................  Internal Reconsideration of
                                             NCD for Cardiac Pacemakers.
                                            Cardiac Pacemakers.
-------------------------------------------
              Medicare Claims Processing (CMS--Pub. 100-04)
------------------------------------------------------------------------
212.......................................  Confidential.
213.......................................  Payment To Be Sent to the
                                             Bank Similar Financial
                                             Institution in the Name of
                                             a Provider.
214.......................................  MSN Message.
                                            Remittance Advice Messages.
                                            Preventive Care.
215.......................................  Implementation of Skilled
                                             Nursing Facility
                                             Consolidated Billing
                                             Common.
                                            Working File Edit for
                                             Therapy Codes Considered
                                             Separately Physician
                                             Services.
                                            Edit for Therapy Services
                                             Separately Payable When
                                             Furnished by a Physician.
216.......................................  Chapter 32.
                                            Coverage and Billing for
                                             Home Prothrombin Time
                                             Monitoring for
                                             Anticoagulation Management.
                                            Coverage Requirements.
                                            Intermediary Payment
                                             Requirements.
                                            Part A Payment Methods.
                                            Intermediary Billing
                                             Procedures.
                                            Bill Types.
                                            Revenue Codes.
                                            Intermediary Allowable
                                             Codes.
                                            Allowable Covered Diagnosis
                                             Codes.
                                            Healthcare Common Procedure
                                             Coding System for
                                             Intermediaries.
                                            Carriers Billing
                                             Instructions.
                                            Healthcare Common Procedure
                                             Coding System for Carriers.
                                            Applicable Diagnosis Code
                                             for Carriers.
                                            Carrier Claims Requirements.
                                            Carrier Payment
                                             Requirements.
                                            Carrier and Intermediary
                                             General Claims Processing
                                             Instructions.
                                            Remittance Advice Notice.
                                            Medicare Summary Notice
                                             Message.
217.......................................  CR 3318, Full Replacement of
                                             CR3223, Implementation of
                                             the Analysis and Design
                                             Phases of the Physician
                                             Scarcity Bonus. CR 3318
                                             rescinds CR 3223.
                                            Billing and Payment in a
                                             Physician Scarcity Area.
                                            Provider Education.
                                            Identifying Physician
                                             Scarcity Area Locations.
                                            Claims Coding Requirements.
                                            Payment.
                                            Services Eligible for the
                                             Physician Scarcity Bonus.
                                            Remittance Messages.
                                            Post-Payment Review.
                                            Administrative and Judicial
                                             Review.
218.......................................  Implementation of the
                                             Analysis and Design Phases
                                             of the Revision to the
                                             Health Professional
                                             Shortage Area Bonus
                                             Payment.
                                            Provider Education.
                                            HPSA Designations.
                                            Claims Coding Requirements.
                                            Services Eligible for Health
                                             Professional Shortage Area
                                             Bonus Payment.
                                            Remittance Messages.
                                            Post-Payment Review.
                                            Administrative and Judicial
                                             Review.
219.......................................  This CR fully replaces CR
                                             3215, Implementation of the
                                             Analysis and Design Phases
                                             of the Revision to the
                                             Health Professional
                                             Shortage Area Bonus
                                             Payment.

[[Page 57316]]

 
220.......................................  Implementation of Section
                                             414 of the Medicare
                                             Prescription Drug,
                                             Improvement, and
                                             Modernization Act of 2003.
                                            General Coverage and Payment
                                             Policies.
                                            Billing Methods.
                                            Definitions.
                                            Carrier Calculation of
                                             Payment Amount.
                                            General.
                                            Components of the Ambulance
                                             Fee Schedule.
                                            Zip Codes Determine Fee
                                             Schedule Amounts.
                                            Transition Overview.
221.......................................  Medicare Inpatient
                                             Rehabilitation Facilities
                                             Classification
                                             Requirements.
                                            Criteria That Must Be Met by
                                             Inpatient Rehabilitation
                                             Hospitals Counting a
                                             Comorbidity as One of the
                                             Listed Medical Conditions.
                                            Criteria That Must Be Met by
                                             Inpatient Rehabilitation
                                             Units.
                                            Verification Process To Be
                                             Used To Determine if the
                                             Inpatient Rehabilitation
                                             Facility Met the
                                             Classification Criteria.
                                            Hospitals That Have Not
                                             Previously Participated in
                                             Medicare.
                                            Changes in the Status of an
                                             Inpatient Rehabilitation
                                             Facility Unit.
                                            New and Converted Inpatient
                                             Rehabilitation Facility
                                             Units.
                                            Retroactive Adjustments for
                                             Provisionally Excluded
                                             Inpatient Rehabilitation
                                             Facilities or Beds.
                                            Verification of Compliance
                                             Using ICD-9-CM and
                                             Impairment Group Codes.
-------------------------------------------
               Medicare Secondary Payer (CMS--Pub. 100-05)
------------------------------------------------------------------------
14........................................  MSP Manual Update CR 2074.
                                            Fiscal and Intermediaries
                                             and Carriers Claim
                                             Processing Rules.
15........................................  Change in Interest
                                             Calculation for Medicare
                                             Overpayment and
                                             Underpayments.
                                            Medicare Secondary Payer
                                             Recovery Claims (Re-Named
                                             and Revised).
16........................................  Update Medicare Secondary
                                             Payer Group Health Recovery
                                             Demand Letters to Employers
                                             and Insurers for Data Match
                                             and Non-Data Match Debts.
                                            Insurer Letter.
-------------------------------------------
            Medicare Financial Management (CMS--Pub. 100-06)
------------------------------------------------------------------------
38........................................  Consolidation of Claims
                                             Crossover--Small Scale
                                             Initial Implementation.
                                            Consolidation of Medicare
                                             and Medicare Supplemental
                                             (Medigap) Health Insurance
                                             Policies.
39........................................  Installation of Version 34.0
                                             of the Provider Statistical
                                             and Reimbursement (PS&R)
                                             Reporting System.
40........................................  Modification of Contractor
                                             Reporting of Operational
                                             and Workload Data Form 5.
                                            Body of Report.
41........................................  Change in Interest
                                             Calculation for Medicare
                                             Overpayments and
                                             Underpayments and Medicare
                                             Secondary Payer Recoveries.
                                            Sample Demand Letter for
                                             Claims Accounts
                                             Receivables.
                                            Interest Accruals.
                                            Procedures for Applying
                                             Interest During Overpayment
                                             Recoupment.
                                            Notification to Provider
                                             Regarding Interest
                                             Assessment.
                                            Waiver and Adjustment of
                                             Interest Charges.
42........................................  Unsolicited/Voluntary
                                             Refunds.
                                            General Information.
                                            Office of Inspector General
                                             Initiatives.
                                            Unsolicited/Voluntary Refund
                                             Accounts.
                                            Receiving and Processing
                                             Unsolicited/Voluntary
                                             Refund Checks When
                                             Identifying Information Is
                                             Provided.
                                            Handling Checks or
                                             Associated Correspondence
                                             With Conditional
                                             Endorsements.
                                            Receiving and Processing
                                             Unsolicited/Voluntary
                                             Refund Checks When
                                             Identifying Information Is
                                             Provided.
                                            CMS Reporting Requirements.
                                            Overpayment Refund Form.
                                            Unsolicited/Voluntary Refund
                                             Checks--Summary Report.
                                            Education.
43........................................  Expanded Identification and
                                             Workload Reporting for CMS
                                             Medicare System.
                                            Provider Overpayment
                                             Requirements System User
                                             Manual.
                                            Request Provider Overpayment
                                             Debt From the Provider
                                             Overpayment Requesting
                                             System.
                                            General Information.
                                            Structure of the Workload
                                             Identifier.
                                            Initial Implementation.
                                            Basic Requirements and Uses
                                             of the Identifier.
                                            Maintenance of Contractor
                                             Workload Identifiers.
44........................................  Notices of New Interest Rate
                                             for Medicare Overpayments
                                             and Underpayments CR 2830.
45........................................  Addition of Instructions for
                                             Form CMS-2591 to Chapter 6.
                                            Monthly Intermediary Part A
                                             and Part B Appeals Report
                                             (Form CMS-2591).
                                            Purpose and Scope.
                                            Due Date.
                                            Completion of Items on Form
                                             CMS-2591.
                                            Heading.

[[Page 57317]]

 
                                            A--Intermediary Appeal
                                             Request.
                                            B--Part B Hearing Results.
                                            C--Part A and Part B ALJ
                                             Hearings.
                                            D--Limitation of Liability.
                                            E--Part A and Part B
                                             Reopenings.
                                            Checking Reports.
46........................................  Installation of Version 33.0
                                             of the Provider Statistical
                                             and Reimbursement Reporting
                                             System-Modification of CR
                                             3131.
47........................................  Expanded Identification and
                                             Workload Reporting for CMS
                                             Medicare Systems.
                                            Provider Overpayment
                                             Requirements System User
                                             Manual.
                                            Request Provider Debts from
                                             the Provider Overpayment
                                             Requirements.
                                            History File.
                                            Request Ad Hoc Reports from
                                             ARMS.
                                            General Information.
                                            Structure of the Workload
                                             Identifier.
                                            Initial Implementation.
                                            Basic Requirements and Uses
                                             of the Identifier.
                                            Maintenance of Contractor
                                             Workload Identifier.
48........................................  This transmittal is
                                             rescinded and Replaced With
                                             Transmittal 50, dated July
                                             30, 2004.
-------------------------------------------
             Medicare State Operations Manual) (Pub. 100-07)
------------------------------------------------------------------------
1.........................................  Release of Basic Manual.
-------------------------------------------
              Medicare Program Integrity (CMS--Pub.100-08)
------------------------------------------------------------------------
770.......................................  New Requirements for Self-
                                             Administered Drug Exclusion
                                             List Articles in the
                                             Medicare Coverage Database
                                             Articles.
71........................................  Program Integrity Manual
                                             Revisions 72 Automated
                                             Prepayment Review.
73........................................  Program Integrity Management
                                             Reporting System Section
                                             7.2 of the Program
                                             Integrity Manual.
74........................................  Skilled Nursing Facility
                                             Certification and
                                             Recertification.
                                            Medical Review of
                                             Certification and
                                             Recertification of
                                             Residents in Skilled
                                             Nursing Facilities.
75........................................  Informing Beneficiaries
                                             About Which Local Medical
                                             Review Policy and /or Local
                                             Coverage Determination and
                                             or National Coverage
                                             Determination Is Associated
                                             with Their Claim Denial.
76........................................  Clarification of Complex
                                             Medical Review.
                                            Types of Prepayment and
                                             Postpayment Review.
77........................................  Instructions for Carriers,
                                             DMERCs, FIs, and Full PSCs
                                             When Interacting With the
                                             Comprehensive Error Rate
                                             Testing (CERT) Contractor
                                             (i.e., Handling Appeals of
                                             CERT-Initiated Denials,
                                             Contracting Non-Responders,
                                             Tracking Over/
                                             Underpayments).
                                            Affiliated Contractor Full
                                             PSC Communication With the
                                             CERT Contractor.
                                            Providing Sample Information
                                             to the CERT Contractor.
                                            Providing Review Information
                                             to the CERT Contractor.
                                            Disputing Disagreeing with a
                                             CERT Decision. Handling
                                             Overpayments and
                                             Underpayments Resulting
                                             from the CERT Findings.
                                            Handling Appeals Resulting
                                             from CERT Initiated
                                             Denials.
                                            Tracking Overpayments and
                                             Appeals.
                                            Tracking Overpayments.
                                            Tracking Appeals.
                                            AC/Full PSC Requirements
                                             Involving CERT Information
                                             Dissemination.
                                            Contracting Non-Responders.
                                            Late Documentation.
                                            Voluntary Refunds.
                                            LMRP/NCD.
                                            Medicare Program Integrity
                                             Manual Exhibits Table of
                                             Contents.
                                            CERT Formats for Carrier and
                                             DMERC Standard System.
                                            CERT PSC Contractor Feedback
                                             Data Entry Screen Version
                                             1.01.
                                            Data Items Included on CERT
                                             Reports.
                                            Acceptable No Resolution
                                             Reasons.
                                            Types of Referral of Non-
                                             Responding Providers.
                                            OIG Referral of Non-
                                             Responding Providers.
                                            Offices of Audit Services--
                                             Regions.
                                            Fee-For-Services-Appeal
                                             Processes.
78........................................  Medical Review Progressive
                                             Corrective Action for Part
                                             A.
-------------------------------------------
 Medicare Contractor Beneficiary and Provider Communications (CMS--Pub.
                                 100-09)
------------------------------------------------------------------------
05........................................  Manual Instruction for
                                             Updated Beneficiary
                                             Services Sections 5104 and
                                             2958, and Beneficiary
                                             Services Section 20 of the
                                             Internet-Only Manual.
                                            Beneficiary Services.
                                            Guidelines for Telephone
                                             Services.
                                            Call Handling Requirements.

[[Page 57318]]

 
                                            Customer Service Assessment
                                             and Management System
                                             Reporting Requirements.
                                            Disclosure of Information
                                             (Adherence to the Privacy
                                             Act and the Health
                                             Insurance Portability and
                                             Accountability Act Privacy
                                             Rule).
                                            Second Level Screening of
                                             Beneficiary and Provider
                                             Inquiries (Activity Code
                                             13201) (CR-2719).
                                            Second Level Screening of
                                             Provider Inquiries
                                             (Miscellaneous Code 13201/
                                             01).
                                            Medicare Customer Service
                                             Next Generation Desktop.
                                            Publication Requests.
                                            Medicare Participating
                                             Physicians and Suppliers
                                             Directory.
                                            Transfer of Part A Telephone/
                                             Written Inquiries Workload.
                                            Local Medical Review Policy
                                             Local Coverage
                                             Determination Requests.
                                            Guidelines for Handling
                                             Beneficiary Written
                                             Inquiries (Activity Code
                                             13002).
                                            Customer Service Plan
                                             (Activity Code 13004).
06........................................  Provider/Supplier
                                             Communications--Revisions
                                             and Additions to Existing
                                             Contractor Requirements.
                                            Provider Services.
                                            Guidelines for Telephone
                                             Service.
                                            Toll Free Network Services.
                                            Publication of Toll Free
                                             Numbers.
                                            Call Handling Requirements.
                                            Customer Service Assessment
                                             and Management System
                                             Reporting Requirements.
                                            CSR Qualifications.
                                            Staff Development and
                                             Training.
                                            Quality Call Monitoring.
                                            Disclosure of Information
                                             (Adherence to the Privacy
                                             Act).
                                            Fraud and Abuse.
                                            Next Generation Desktop.
                                            Call Center User Group.
                                            Performance Improvements.
                                            Guidelines for Handling
                                             Written Inquiries.
                                            Contractor Guidelines for
                                             High Quality Written
                                             Responses to Inquiries.
                                            Walk-In-Inquiries.
                                            Guidelines for High Quality
                                             Walk-In-Service.
                                            Surveys.
-------------------------------------------
                Medicare Managed Care (CMS--Pub. 100-16)
------------------------------------------------------------------------
48........................................  Grievances, Organization
                                             Determinations, and
                                             Appeals.
49........................................  Chapter 4--Benefits and
                                             Beneficiary Protections.
50........................................  Chapter 20--Plan
                                             Communications Guide.
51........................................  Revisions to Chapter 2--
                                             Medicare+Choice Enrollment
                                             and Disenrollment.
52........................................  Chapter 17a and 17b.
53........................................  Chapter 11--Revisions.
54........................................  Chapter 19--Revisions.
55........................................  Chapter 10, Organization
                                             Compliance With State Law
                                             and Preemption by Federal
                                             Law.
-------------------------------------------
                One Time Notification (CMS--Pub. 100-20)
------------------------------------------------------------------------
67........................................  Transmittal 67, Dated April
                                             2, 2004, Was Rescinded and
                                             Replaced With Transmittal
                                             81 dated May 14, 2004.
68........................................  Transmittal 49
                                             Implementation Data
                                             Extension.
69........................................  Carrier Only Shared System
                                             Maintainer Hours for
                                             Resolution of Problems
                                             Detected as a Result of
                                             Implementation of CR 2525
                                             and CR 2527.
70........................................  How Fiscal Intermediaries
                                             Are To Record Coinsurance
                                             Amounts From the Provider.
                                            Statistical and
                                             Reimbursement Report for
                                             Providers Who Elected To
                                             Accept Reduced Coinsurance
                                             for Outpatient Prospective
                                             Payment System Services.
71........................................  Update to the Healthcare
                                             Provider Taxonomy Codes
                                             Version 4.0.
72........................................  Pub. 100-20, Transmittal 72,
                                             dated April 16, 2004, Is
                                             Rescinded and Replaced With
                                             Pub. 100-20, Transmittal 82
                                             Dated May 14, 2004.
73........................................  Revised American National
                                             Standards Institute X12N
                                             837 Professional Health
                                             Care Claims Companion
                                             Document.
74........................................  Emergency Correction
                                             Regarding Correction to
                                             Healthcare Common
                                             Procedure.
                                            Coding System Codes for Low
                                             Osmolar Contrast Material.
75........................................  One Time Instructions for
                                             Audit Intermediary Cost
                                             Reporting Processes To
                                             Accommodate Claims
                                             Processing Error That
                                             Prevented Some Supply
                                             Charges From Being Reported
                                             on Home Health Prospective
                                             Payment System Claim.
76........................................  Shared System Maintainer
                                             Hours for Resolution of
                                             Problems Detected During
                                             Health Insurance
                                             Portability and
                                             Accountability Act
                                             Transaction Release
                                             Testing.
77........................................  Instructions Related to
                                             Redistribution of Unused
                                             Resident Positions, Section
                                             422 of the Modernization
                                             Act of 2003 (MMA), P.L. 108-
                                             173, for Purposes of
                                             Graduate Medical Education
                                             Payment.
78........................................  Renovate Override Code
                                             Processing in Common
                                             Working File.
79........................................  18-Month Moratorium on
                                             Physician Self-Referrals to
                                             Specialty Hospitals;
                                             Processing of Form CMS-855A
                                             Applications To Become a
                                             Medicare Certified
                                             Hospital.
80........................................  Medicare System Acceptance
                                             of New Provider Numbers for
                                             Home Health Agencies.

[[Page 57319]]

 
81........................................  Requirement for Carriers,
                                             Durable Medical Equipment
                                             Regional Carriers, Fiscal
                                             Intermediaries, and Full
                                             Program Safeguard
                                             Contractors To Encourage
                                             Providers To Submit Medical
                                             Records to the
                                             Comprehensive Error Rate
                                             Testing Contractor for Use
                                             in the November 2004
                                             Improper Medicare Fee-For-
                                             Service Payment Report.
82........................................  This OTN Replaces Pub. 100-
                                             20, Transmittal 72, dated
                                             April 16, 2004.
                                            Changes in Determining Rural
                                             Status of Hospitals for
                                             Transitional Outpatient
                                             Payments for 2004.
83........................................  Additional Health Insurance
                                             Health Insurance
                                             Portability and
                                             Accountability Act
                                             Coordination of Benefits
                                             Information for Trading
                                             Partners.
84........................................  Reporting Medicare Secondary
                                             Payer Information on the
                                             Health Insurance
                                             Portability and
                                             Accountability Act of 1996
                                             X12N 837 Created via Free
                                             Billing Software.
85........................................  CD-ROM Initiative for
                                             Distribution of the Annual
                                             Disclosure, Dear Doctor
                                             Letter and Participation
                                             Enrollment Material.
86........................................  Interface File From Recovery
                                             Management and Accounting
                                             System.
87........................................  Instructions Related to
                                             Redistribution of Unused
                                             Resident Positions, Section
                                             422 of the Medicare
                                             Modernization Act of 2003,
                                             P.L. 108-173, for Purpose
                                             of Graduate Medical
                                             Education Payments.
88........................................  Clarification and Revision
                                             of Change Request 3084,
                                             Implementation of Section
                                             508 of the Medicare
                                             Prescription Drug,
                                             Improvement, and
                                             Modernization Act of 2003,
                                             (Public Law 108-173).
89........................................  Shared System Maintainer
                                             Hours for Resolution of
                                             Problems Detected As a
                                             Result of Implementation of
                                             CR 2525 and CR 2527.
90........................................  MMA Drug Pricing Update-
                                             Payment Limits for J7308
                                             (Levulan Kerastick) and
                                             J9395 (Faslodex).
------------------------------------------------------------------------


                      Addendum IV.--Regulation Documents Published in the Federal Register
                                         [April 2004 through June 2004]
----------------------------------------------------------------------------------------------------------------
                                  FR Vol.  69       CFR parts
        Publication  date           page no.        affected             File code         Title of regulation
----------------------------------------------------------------------------------------------------------------
April 6, 2004...................        17935  42 CFR part 414...  CMS-1380-IFC          Medicare Program;
                                                                                          Manufacturer
                                                                                          Submission of
                                                                                          Manufacturer's Average
                                                                                          Sales Price (ASP) Data
                                                                                          for Medicare Part B
                                                                                          Drugs and Biologicals.
April 6, 2004...................        17933  42 CFR parts 411    CMS-1810-CN           Medicare Program;
                                                and 424.                                  Physicians' Referrals
                                                                                          to Health Care
                                                                                          Entities With Which
                                                                                          They Have Financial
                                                                                          Relationships (Phase
                                                                                          II); Correction.
April 23, 2004..................        22083  ..................  CMS-1363-N            Medicare Program;
                                                                                          Meeting of the
                                                                                          Practicing Physicians
                                                                                          Advisory Council.
April 23, 2004..................        22081  ..................  CMS-4071-N2           Medicare Program;
                                                                                          Listening Sessions on
                                                                                          Performance Measures
                                                                                          for Public Reporting
                                                                                          on the Quality of
                                                                                          Hospital Care During
                                                                                          April, May, and June
                                                                                          2004.
April 23, 2004..................        22080  ..................  CMS-4066-N            Medicare Program;
                                                                                          Meeting of the
                                                                                          Advisory Panel on
                                                                                          Medicare Education--
                                                                                          May 11, 2004, Friday,
                                                                                          April 23, 2004.
April 23, 2004..................        22079  ..................  CMS-1273-N            Medicare Program;
                                                                                          Public Meetings in
                                                                                          Calendar Year 2004 for
                                                                                          New Durable Medical
                                                                                          Equipment Coding and
                                                                                          Payment
                                                                                          Determinations.
April 23, 2004..................        22065  ..................  CMS-5004-N            Medicare Program;
                                                                                          Voluntary Chronic Care
                                                                                          Improvement Under
                                                                                          Traditional Fee-for-
                                                                                          Service Medicare.
April 23, 2004..................        21963  42 CFR part 424...  CMS-1185-F            Medicare Program;
                                                                                          Elimination of
                                                                                          Statement of Intent
                                                                                          Procedures for Filing
                                                                                          Medicare Claims.
May 7, 2004.....................        25752  42 CFR part 412...  CMS-1262-F            Medicare Program;
                                                                                          Changes to the
                                                                                          Criteria for Being
                                                                                          Classified as an
                                                                                          Inpatient
                                                                                          Rehabilitation
                                                                                          Facility.
May 7, 2004.....................        25674  42 CFR part 412...  CMS-126-F             Medicare Program;
                                                                                          Prospective Payment
                                                                                          System for Long-Term
                                                                                          Care Hospitals: Annual
                                                                                          Payment Rate Updates
                                                                                          and Policy Changes,
                                                                                          Part II.
May 18, 2004....................        28196  42 CFR parts 403,   CMS-1428-P            Medicare Program;
                                                412, 413, 418,                            Proposed Changes to
                                                460, 480, 482,                            the Hospital Inpatient
                                                483, 485, and 489.                        Prospective Payment
                                                                                          Systems and Fiscal
                                                                                          Year 2005 Rates, Part
                                                                                          II.
May 18, 2004....................        28133  ..................  CMS-2189-N            Medicaid Program; Real
                                                                                          Choice Systems Change
                                                                                          Grants.
May 28, 2004....................        30660  ..................  CMS-3130-N            Medicare Program;
                                                                                          Meeting of the
                                                                                          Medicare Coverage
                                                                                          Advisory Committee--
                                                                                          July 14, 2004.
May 28, 2004....................        30659  ..................  CMS-4069-N            Medicare Program; Open
                                                                                          Public Meeting To
                                                                                          Discuss Definitions of
                                                                                          Regions for Regional
                                                                                          Medicare Preferred
                                                                                          Provider Organizations
                                                                                          and Prescription Drug
                                                                                          Plans Under the
                                                                                          Medicare Modernization
                                                                                          Act--July 21, 2004.
May 28, 2004....................        30658  ..................  CMS-1266-N            Medicare Program;
                                                                                          Public Meeting in
                                                                                          Calendar Year 2004 for
                                                                                          New Clinical
                                                                                          Laboratory Tests
                                                                                          Payment
                                                                                          Determinations.
May 28, 2004....................        30656  ..................  CMS-2195-N            Medicaid Program;
                                                                                          Demonstration To
                                                                                          Improve the Direct
                                                                                          Service Community
                                                                                          Workforce.

[[Page 57320]]

 
May 28, 2004....................        30654  ..................  CMS-1269-N            Medicare Program;
                                                                                          Establishment of the
                                                                                          Emergency Medical
                                                                                          Treatment and Labor
                                                                                          Act (EMTALA) Technical
                                                                                          Advisory Group (TAG)
                                                                                          and Request for
                                                                                          Nominations for
                                                                                          Members.
May 28, 2004....................        30580  42 CFR part 440...  CMS-2132-F            Medicaid Program;
                                                                                          Provider
                                                                                          Qualifications for
                                                                                          Audiologists.
June 2, 2004....................        31248  42 CFR part 484...  CMS-1265-P            Medicare Program; Home
                                                                                          Health Prospective
                                                                                          Payment System Rate
                                                                                          Update for Calendar
                                                                                          Year 2005, Part IV.
June 2, 2004....................        31125  ..................  CMS-1279-N            Medicare Program;
                                                                                          Request for
                                                                                          Nominations for the
                                                                                          Program Advisory
                                                                                          Oversight Committee
                                                                                          for the Competitive
                                                                                          Acquisition of Durable
                                                                                          Medical Equipment and
                                                                                          Other Items.
June 2, 2004....................        31123  ..................  CMS-5033-N            Medicare Program;
                                                                                          Establishment of the
                                                                                          Advisory Board on the
                                                                                          Demonstration of a
                                                                                          Bundled Case-Mix
                                                                                          Adjusted Payment
                                                                                          System for End Stage
                                                                                          Renal Disease Services
                                                                                          and Request for
                                                                                          Nominations for
                                                                                          Members.
June 18, 2004...................        34169  ..................  CMS-2200-N3           Medicare Program;
                                                                                          Meeting of the State
                                                                                          Pharmaceutical
                                                                                          Assistance Transition
                                                                                          Commission--July 7,
                                                                                          2004.
June 22, 2004...................        34585  42 CFR part 412...  OFR-generated         Prospective Payment
                                                                    correction            Systems for Inpatient
                                                                                          Hospital Services--OFR
                                                                                          Correction.
June 25, 2004...................        35920  42 CFR parts 403,   CMS-1428-CN           Medicare Program;
                                                412, 413, 418,                            Proposed Changes to
                                                460, 480, 482,                            the Hospital Inpatient
                                                483, 485, and 489.                        Prospective Payment
                                                                                          Systems and Fiscal
                                                                                          Year 2005 Rates;
                                                                                          Correction, Part V.
June 25, 2004...................        35716  42 CFR parts 405,   CMS-1727-P            Medicare Program;
                                                413, and 417.                             Provider Reimbursement
                                                                                          Determinations and
                                                                                          Appeals, Part II.
June 25, 2004...................        35650  ..................  CMS-3134-N            Medicare Program; Town
                                                                                          Hall Meeting on
                                                                                          Potential Facility
                                                                                          Qualifications for
                                                                                          Expanded Coverage of
                                                                                          Percutaneous
                                                                                          Transluminal
                                                                                          Angioplasty for
                                                                                          Carotid Stenting
                                                                                          Procedures
June 25, 2004...................        35634  ..................  CMS-9022-N            Medicare and Medicaid
                                                                                          Programs; Quarterly
                                                                                          Listing of Program
                                                                                          Issuances--January
                                                                                          2004 Through March
                                                                                          2004.
June 25, 2004...................        35634  ..................  CMS-2189-CN           Medicaid Program; Real
                                                                                          Choice Systems Change
                                                                                          Grants; Correction
                                                                                          Notice.
June 25, 2004...................        35529  42 CFR part 411...  CMS-1809-F5           Medicare and Medicaid
                                                                                          Programs; Physicians'
                                                                                          Referrals to Health
                                                                                          Care Entities With
                                                                                          Which They Have
                                                                                          Financial
                                                                                          Relationships:
                                                                                          Extension of Partial
                                                                                          Delay of Effective
                                                                                          Date.
June 25, 2004...................        35529  42 CFR part 409...  CMS-1469-F2           Medicare Program;
                                                                                          Prospective Payment
                                                                                          System and
                                                                                          Consolidated Billing
                                                                                          for Skilled Nursing
                                                                                          Facilities; Correcting
                                                                                          Amendment.
June 25, 20043..................        35527  42 CFR parts 405    CMS-1372-CN2          Medicare Program;
                                                and 414.                                  Changes to Medicare
                                                                                          Payment for Drugs and
                                                                                          Physician Fee Schedule
                                                                                          Payments for Calendar
                                                                                          Year 2004: Correction.
June 29, 2004...................        38898  ..................  CMS-5025-N            Medicare Program;
                                                                                          Medicare Replacement
                                                                                          Drug Demonstration.
----------------------------------------------------------------------------------------------------------------

Addendum V--National Coverage Determinations

[April 2004 Through June 2004]

    A national coverage determination (NCD) is a determination by 
the Secretary with respect to whether or not a particular item or 
service is covered nationally under Title XVIII of the Social 
Security Act, but does not include a determination of what code, if 
any, is assigned to a particular item or service covered under this 
title, or determination with respect to the amount of payment made 
for a particular item or service so covered. We include below all of 
the NCDs that were issued during the quarter covered by this notice. 
The entries below include information concerning completed decisions 
as well as sections on program and decision memoranda, which also 
announce pending decisions or, in some cases, explain why it was not 
appropriate to issue an NCD. We identify completed decisions by the 
section of the NCDM in which the decision appears, the title, the 
date the publication was issued, and the effective date of the 
decision. Information on completed decisions as well as pending 
decisions has also been posted on the CMS Web site at http://cms.hhs.gov/coverage.

[[Page 57321]]



                    National Coverage Determinations
                     [April 2004 Through June 2004]
------------------------------------------------------------------------
                                                              Effective
       Pub. 100-03 NCDM             Title        Issue Date      Date
------------------------------------------------------------------------
80.2.........................  Ocular               4/01/04      4/01/04
                                Photodynamic
                                Therapy With
                                Verteporfin
                                for Age-
                                Related
                                Macular
                                Degeneration.
30.3.........................  Acupuncture for      4/16/04      4/16/04
                                Fibromyalgia.
30.3.........................  Acupuncture for      4/16/04      4/16/04
                                Osteoarthritis.
110.8.1......................  Stem Cell            5/28/04      7/06/04
                                Transplantatio
                                n.
150.9........................  Arthroscopic         6/10/04      7/11/04
                                Lavage and
                                Arthroscopic
                                Debridement
                                for the
                                Osteoarthritic
                                Knee.
160.23.......................  Sensory Nerve        6/18/04      4/01/04
                                Conduction
                                Threshold
                                Tests.
20.8.........................  Cardiac              6/25/04      4/30/04
                                Pacemakers.
------------------------------------------------------------------------

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 non-experimental IDEs. To obtain more 
information about the classes or categories, please refer to the 
Federal Register notice published on April 21, 1997 (62 FR 19328).
    The following list includes all Category B IDEs approved by FDA 
during the 2nd quarter, April 2004 through June 2004.

------------------------------------------------------------------------
                    IDE                                Category
------------------------------------------------------------------------
G010048....................................  B
G030067....................................  B
G030123....................................  B
G030163....................................  B
G030242....................................  B
G030251....................................  B
G040003....................................  B
G040004....................................  B
G040011....................................  B
G040036....................................  B
G040038....................................  B
G040050....................................  B
G040053....................................  B
G040054....................................  B
G040055....................................  B
G040056....................................  B
G040058....................................  B
G040059....................................  B
G040060....................................  B
G040061....................................  B
G040062....................................  B
G040066....................................  B
G040067....................................  B
G040068....................................  B
G040069....................................  B
G040075....................................  B
G040076....................................  B
G040077....................................  B
G040078....................................  B
G040079....................................  B
G040080....................................  B
G040083....................................  B
G040085....................................  B
G040087....................................  B
G040089....................................  B
G040093....................................  B
G040106....................................  B
------------------------------------------------------------------------

Addendum VII.--Approval Numbers for Collections of Information

    Below we list all approval numbers for collections of 
information in the referenced sections of CMS regulations in title 
42; title 45, subchapter C; and title 20 of the Code of Federal 
Regulations, which have been approved by the Office of Management 
and Budget:

                           OMB control numbers
    [Approved CFR sections in title 42, title 45, and title 20 (Note:
 Sections in Title 45 are preceded by ``45 CFR,'' and sections in Title
                     20 are preceded by ``20 CFR'')]
------------------------------------------------------------------------
                OMB No.                       Approved CFR sections
------------------------------------------------------------------------
0938-0008..............................  414.40, 424.32, 424.44.
0938-0022..............................  413.20, 413.24, 413.106.
0938-0023..............................  424.103.
0938-0025..............................  406.28, 407.27.
0938-0027..............................  486.100-486.110.
0938-0033..............................  405.807.
0938-0035..............................  407.40.
0938-0037..............................  413.20, 413.24.
0938-0041..............................  408.6, 408.22.
0938-0042..............................  410.40, 424.124.
0938-0045..............................  405.711.
0938-0046..............................  405.2133.
0938-0050..............................  413.20, 413.24.
0938-0062..............................  431.151, 435.1009, 440.250,
                                          440.220, 442.1, 442.10-442.16,
                                          442.30, 442.40, 442.42,
                                          442.100-442.119, 483.400-
                                          483.480, 488.332, 488.400,
                                          498.3-498.5.
0938-0065..............................  485.701-485.729.
0938-0074..............................  491.1-491.11.
0938-0080..............................  406.7, 406.13.
0938-0086..............................  420.200-420.206, 455.100-
                                          455.106.
0938-0101..............................  430.30.
0938-0102..............................  413.20, 413.24.
0938-0107..............................  413.20, 413.24.
0938-0146..............................  431.800-431.865.
0938-0147..............................  431.800-431.865.
0938-0151..............................  493.1405, 493.1411, 493.1417,
                                          493.1423, 493.1443, 493.1449,
                                          493.1455, 493.1461, 493.1469,
                                          493.1483, 493.1489.
0938-0155..............................  405.2470.
0938-0170..............................  493.1269-493.1285.
0938-0193..............................  430.10-430.20, 440.167.

[[Page 57322]]

 
0938-0202..............................  413.17, 413.20.
0938-0214..............................  411.25, 489.2, 489.20.
0938-0236..............................  413.20, 413.24.
0938-0242..............................  488.26, 442.30.
0938-0245..............................  407.10, 407.11.
0938-0246..............................  431.800-431.865.
0938-0251..............................  406.7.
0938-0266..............................  416.41, 416.83, 416.47, 416.48.
0938-0267..............................  485.56, 485.58, 485.60, 485.64,
                                          485.66, 410.65.
0938-0269..............................  412.116, 412.632, 413.64,
                                          413.350, 484.245.
0938-0270..............................  405.376.
0938-0272..............................  440.180, 441.300-441.305.
0938-0273..............................  485.701-485.729.
0938-0279..............................  424.5.
0938-0287..............................  447.31.
0938-0296..............................  413.170, 413.184.
0938-0300..............................  431.800.
0938-0301..............................  413.20, 413.24.
0938-0302..............................  418.22, 418.24, 418.28, 418.56,
                                          418.58, 418.70, 418.74,
                                          418.83, 418.96, 418.100.
0938-0313..............................  418.1-418.405.
0938-0328..............................  482.12, 482.13, 482.21, 482.22,
                                          482.27, 482.30, 482.41,
                                          482.43, 482.45, 482.53,
                                          482.56, 482.57, 482.60,
                                          482.61, 482.62, 482.66,
                                          485.618, 485.631.
0938-0334..............................  491.9, 491.10.
0938-0338..............................  486.104, 486.106, 486.110.
0938-0354..............................  441.60.
0938-0355..............................  488.26, 442.30.
0938-0357..............................  409.40-409.50, 410.36, 410.170,
                                          411.4-411.15, 421.100, 424.22,
                                          484.18, 489.21.
0938-0358..............................  412.20-412.30.
0938-0359..............................  412.40-412.52.
0938-0360..............................  488.60.
0938-0365..............................  484.10, 484.11, 484.12, 484.14,
                                          484.16, 484.18, 484.20,
                                          484.36, 484.48, 484.52.
0938-0372..............................  414.330.
0938-0378..............................  482.60-482.62.
0938-0379..............................  488.26, 442.30.
0938-0382..............................  488.26, 442.30.
0938-0386..............................  405.2100-405.2171.
0938-0391..............................  488.18, 488.26, 488.28.
0938-0426..............................  476.104, 476.105, 476.116,
                                          476.134.
0938-0429..............................  447.53.
0938-0443..............................  473.18, 473.34, 473.36, 473.42.
0938-0444..............................  1004.40, 1004.50, 1004.60,
                                          1004.70.
0938-0445..............................  412.44, 412.46, 431.630,
                                          456.654, 466.71, 466.73,
                                          466.74, 466.78.
0938-0447..............................  405.2133.
0938-0448..............................  405.2133, 45 CFR 5, 5b; 20 CFR
                                          part 401 and part 422, subpart
                                          E.
0938-0449..............................  440.180, 441.300-441.310.
0938-0454..............................  424.20.
0938-0456..............................  412.105.
0938-0463..............................  413.20, 413.24, 413.106.
0938-0467..............................  431.17, 431.306, 435.910,
                                          435.920, 435.940-435.960.
0938-0469..............................  417.107, 417.478.
0938-0470..............................  417.143, 422.6, 417.800-
                                          417.840.
0938-0477..............................  412.92.
0938-0484..............................  424.123.
0938-0501..............................  406.15.
0938-0502..............................  433.138.
0938-0512..............................  486.304, 486.306, 486.307.
0938-0526..............................  475.102, 475.103, 475.104,
                                          475.105, 475.106.
0938-0534..............................  410.38, 424.5.
0938-0544..............................  493.1-493.2001.
0938-0564..............................  411.32.
0938-0565..............................  411.20-411.206.
0938-0566..............................  411.404, 411.406, 411.408.
0938-0573..............................  412.256, 412.230.
0938-0578..............................  447.534.
0938-0581..............................  493.1-493.2001.
0938-0599..............................  493.1-493.2001.
0938-0600..............................  405.371, 405.378, 413.20.
0938-0610..............................  417.436, 417.801, 422.128,
                                          430.12, 431.20, 431.107,
                                          434.28, 483.10, 484.10,
                                          489.102.

[[Page 57323]]

 
0938-0612..............................  493.801, 493.803, 493.1232,
                                          493.1233, 493.1234, 493.1235,
                                          493.1236, 493.1239, 493.1241,
                                          493.1242, 493.1249, 493.1251,
                                          493.1252, 493.1253, 493.1254,
                                          493.1255, 493.1256, 493.1261,
                                          493.1262, 493.1263, 493.1269,
                                          493.1273, 493.1274, 493.1278,
                                          493.1283, 493.1289, 493.1291,
                                          493.1299.
0938-0618..............................  433.68, 433.74, 447.272.
0938-0653..............................  493.1771, 493.1773, 493.1777.
0938-0657..............................  405.2110, 405.2112.
0938-0658..............................  405.2110, 405.2112.
0938-0659..............................  456.700, 456.705, 456.709,
                                          456.711, 456.712.
0938-0667..............................  482.12, 488.18, 489.20, 489.24.
0938-0679..............................  410.38.
0938-0685..............................  410.32, 410.71, 413.17, 424.57,
                                          424.73, 424.80, 440.30,
                                          484.12.
0938-0686..............................  493.551-493.557.
0938-0688..............................  486.304, 486.306, 486.307,
                                          486.310, 486.316, 486.318,
                                          486.325.
0938-0690..............................  488.4-488.9, 488.201.
0938-0691..............................  412.106.
0938-0692..............................  466.78, 489.20, 489.27.
0938-0701..............................  422.152.
0938-0702..............................  45 CFR 146.111, 146.115,
                                          146.117, 146.150, 146.152,
                                          146.160, 146.180.
0938-0703..............................  45 CFR 148.120, 148.124,
                                          148.126, 148.128.
0938-0713..............................  441.16, 489.66, 489.67.
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..............................  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.
0938-0770..............................  410.2.
0938-0778..............................  422.111, 422.64.
0938-0779..............................  417.470, 417.126, 422.210,
                                          422.64.
0938-0781..............................  411.404-411.406, 484.10.
0938-0783..............................  422.66, 422.562, 422.564,
                                          422.568, 422.570, 422.572,
                                          422.582, 422.584, 422.586,
                                          422.590, 422.594, 422.602,
                                          422.612, 422.618, 422.619,
                                          422.620, 422.622.
0938-0786..............................  438.352, 438.360, 438.362,
                                          438.364.
0938-0787..............................  406.28, 407.27.
0938-0790..............................  460.12, 460.22, 460.26, 460.30,
                                          460.32, 460.52, 460.60,
                                          460.70, 460.71, 460.72,
                                          460.74, 460.80, 460.82,
                                          460.98, 460.100, 460.102,
                                          460.104, 460.106, 460.110,
                                          460.112, 460.116, 460.118,
                                          460.120, 460.122, 460.124,
                                          460.132, 460.152, 460.154,
                                          460.156, 460.160, 460.164,
                                          460.168, 460.172, 460.190,
                                          460.196, 460.200, 460.202,
                                          460.204, 460.208, 460.210.
0938-0792..............................  491.8, 491.11.
0938-0798..............................  413.24, 413.65, 419.42.
0938-0802..............................  419.43.
0938-0818..............................  410.141, 410.142, 410.143,
                                          410.144, 410.145, 410.146,
                                          414.63.
0938-0829..............................  422.568.
0938-0832..............................  489.
0938-0833..............................  483.350-483.376.
0938-0841..............................  431.636, 457.50, 457.60,
                                          457.70, 457.340, 457.350,
                                          457.431, 457.440, 457.525,
                                          457.560, 457.570, 457.740,
                                          457.750, 457.810, 457.940,
                                          457.945, 457.965, 457.985,
                                          457.1005, 457.1015, 457.1180.
0938-0842..............................  412.23, 412.604, 412.606,
                                          412.608, 412.610, 412.614,
                                          412.618, 412.626, 413.64.
0938-0846..............................  411.1, 411.350-411.357, 424.22.
0938-0857..............................  419.
0938-0860..............................  419.
0938-0866..............................  45 CFR part 162.
0938-0872..............................  483.20, 413.337.
0938-0873..............................  422.152.
0938-0874..............................  45 CFR parts 160 and 162.
0938-0878..............................  Part 422 subparts F and G.
0938-0883..............................  45 CFR parts 160 and 164.
0938-0884..............................  405.940.
0938-0887..............................  45 CFR 148.316, 148.318,
                                          148.320.

[[Page 57324]]

 
0938-0897..............................  412.22, 412.533.
0938-0907..............................  412.230, 412.304, 413.65.
0938-0910..............................  422.624, 422.626, 422.620.
0938-0911..............................  426.400, 426.500.
0938-0916..............................  483.16.
0938-0920..............................  438.6, 438.8, 438.10, 438.12,
                                          438.50, 438.56, 438.102,
                                          438.114, 438.202, 438.206,
                                          438.207, 438.240, 438.242,
                                          438.402, 438.404, 438.406,
                                          438.408, 438.410, 438.414,
                                          438.416, 438.710, 438.722,
                                          438.724, 438.810.
------------------------------------------------------------------------

[FR Doc. 04-21202 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-03-P