[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78428-78442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28156]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9024-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July 2004 Through September 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 July 2004 through September 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

[[Page 78429]]

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 
Timothy Jennings, Office of Strategic Operations and Regulatory 
Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 
786-2134.
    Questions concerning 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 regulations and general notices published in the 
Federal Register during the quarter covered by this notice. For each 
item, we list the--
    [cir] Date published;
    [cir] Federal Register citation;
    [cir] Parts of the Code of Federal Regulations (CFR) that have 
changed (if applicable);
    [cir] Agency file code number; and
    [cir] Title of the regulation.
     Addendum V includes completed NCDs, or reconsiderations of 
completed NCDs, from the quarter covered by this notice. Completed 
decisions are identified by the section of the NCDM in which the 
decision appears, the title, the date the publication was issued, and 
the effective date of the decision.
     Addendum VI includes listings of the FDA-approved IDE 
categorizations, using the IDE numbers the FDA assigns. The listings 
are organized according to the categories to which the device numbers 
are assigned (that is, Category A or Category B), and identified by the 
IDE number.
     Addendum VII includes listings of all approval numbers 
from the Office of Management and Budget (OMB) for collections of 
information in CMS regulations in title 42; title 45, subchapter C; and 
title 20 of the CFR.

III. How to Obtain Listed Material

A. Manuals

    Those wishing to subscribe to program manuals should contact either 
the Government Printing Office (GPO)

[[Page 78430]]

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 National Coverage 
Determinations publication titled ``Islet Cell Transplantation,'' use 
CMS-Pub. 100-03, Transmittal No. 18.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)

    Dated: December 13, 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.

June 28, 2002 (67 FR 43762)
September 27, 2002 (67 FR 61130)
December 27, 2002 (67 FR 79109)
March 28, 2003 (68 FR 15196)
June 27, 2003 (68 FR 38359)
September 26, 2003 (68 FR 55618)
December 24, 2003 (68 FR 74590)
March 26, 2004 (69 FR 15837)
June 25, 2004 (69 FR 35634)
September 24, 2004 (69 FR 57312)

Addendum II--Description of Manuals, Memoranda, and CMS Rulings

    An extensive descriptive listing of Medicare manuals and memoranda 
was published on June 9, 1988, at 53 FR 21730 and supplemented on 
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 
50577. Also, a complete description of the former CIM (now the NCDM) 
was published on August 21, 1989, at 54 FR 34555. A brief description 
of the various Medicaid manuals and memoranda that we maintain was 
published on October 16, 1992, at 57 FR 47468.

[[Page 78431]]



  Addendum III.--Medicare and Medicaid Manual Instructions July Through
                             September 2004
------------------------------------------------------------------------
           Transmittal No.             Manual/Subject/Publication Number
------------------------------------------------------------------------
             Medicare General Information (CMS-Pub. 100-01)
------------------------------------------------------------------------
08...................................  Standard Terminology for Claims
                                        Processing Systems Standard
                                        Terminology Chart.
09...................................  Transmittal rescinded and
                                        replaced with Transmittal 10.
10...................................  Update to Medicare Deductible,
                                        Coinsurance and Premium Rates
                                        for Calendar Year 2005.
                                       Basis for Determining the Part A
                                        Coinsurance Amounts.
                                       Part B Annual Deductible.
--------------------------------------
                Medicare Benefit Policy (CMS-Pub. 100-02)
------------------------------------------------------------------------
18...................................  This revision rescinded
                                        Transmittal 12.
19...................................  Hospital Services Covered Under
                                        Part B Outpatient Observation
                                        Services.
20...................................  This revision rescinded
                                        Transmittal 17.
21...................................  Medicare Comprehensive Outpatient
                                        Rehabilitation Facility
                                        Coverage.
                                       Comprehensive Outpatient
                                        Rehabilitation Facility Services
                                        Provided by Medicare.
                                       Required Services.
                                       Optional Comprehensive Outpatient
                                        Rehabilitation Facility
                                        Services.
                                       Rules for Provision of Services.
                                       Physician's Services.
                                       Physical Therapy Services.
                                       Occupational Therapy Services.
                                       Speech-Language Pathology
                                        Services.
                                       Respiratory Therapy Services.
                                       Prosthetic and Orthotic Devices
                                        and Supplies.
                                       Social Services.
                                       Psychological Services.
                                       Nursing Services.
                                       Drugs and Biologicals.
                                       Home Environment Evaluation.
                                       Outpatient Mental Health
                                        Treatment Limitation.
22...................................  This revision rescinded
                                        transmittal 15.
--------------------------------------
       Medicare National Coverage Determinations (CMS-Pub. 100-03)
------------------------------------------------------------------------
17...................................  Manualization of the Negotiated
                                        Clinical Diagnostic Laboratory
                                        National Coverage
                                        Determinations.
                                       Urine Culture, Bacterial.
                                       Human Immunodeficiency Virus
                                        Testing (Prognosis Including
                                        Monitoring).
                                       Human Immunodeficiency Virus
                                        Testing (Diagnosis).
                                       Blood Counts.
                                       Partial Thromboplastin Time.
                                       Prothrombin Time.
                                       Serum Iron Studies.
                                       Collagen Crosslinks, Any Method.
                                       Blood Glucose Testing.
                                       Glycated Hemoglobin/Glycated
                                        Protein.
                                       Thyroid Testing.
                                       Lipid Testing.
                                       Digoxin Therapeutic Drug Assay.
                                       Alpha-fetoprotein.
                                       Carcinoembryonic Antigen.
                                       Human Chorionic Gonadotropin.
                                       Tumor Antigen by Immunoassay.
                                       Prostate Specific Antigen.
                                       Gamma Glutamyl Transferase.
                                       Hepatitis Panel/Acute Hepatitis
                                        Panel.
                                       Fecal Occult Blood Test.
18...................................  Islet Cell Transplantation.
                                       Pancreas Transplants (Effective
                                        July 1, 1999).
                                       Islet Cell Transplantation in the
                                        Context of a Clinical Trial
                                        (Effective October 1, 2004).
19...................................  Blood-Derived Products for
                                        Chronic Non-Healing Wounds.
20...................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to sensitivity of
                                        Instruction.
21...................................  Magnetic Resonance Spectroscopy
                                        for Diagnosing Brain Tumors.
                                       Magnetic Resonance Imaging.
                                       Magnetic Resonance Spectroscopy.
                                       Magnetic Resonance Angiography.
--------------------------------------
              Medicare Claims Processing (CMS-Pub. 100-04).
------------------------------------------------------------------------
222..................................  Skilled Nursing Facility
                                        Consolidated Billing
                                        Requirements for Durable Medical
                                        Equipment Prosthetic, Orthotics
                                        & Supplies.
                                       Skilled Nursing Facility
                                        Consolidated Billing and Durable
                                        Medical Equipment Provided by
                                        Durable Medical Equipment
                                        Prosthetic, Orthotics & Supplies
                                        Suppliers.
                                       General Information.

[[Page 78432]]

 
223..................................  Positron Emissions Tomography
                                        Scans and Related Claims
                                        Processing.
                                       Positron Emission Tomography
                                        Scans--General Information.
                                       Billing Instructions.
                                       Use of Gamma Cameras and Full
                                        Ring and Partial Ring Positron
                                        Emissions Scanners.
                                       Positron Emission Tomography Scan
                                        Qualifying Conditions and
                                        Health.
                                       Common Procedure Coding System
                                        Code Chart.
                                       Positron Emissions Tomography
                                        Scans for Imaging of the
                                        Perfusion of the Heart Using
                                        Rubidium 82.
                                       Expanded Coverage of Positron
                                        Emission Tomography Scans for
                                        Solitary Pulmonary Nodules.
                                       Expanded Coverage of Positron
                                        Emissions Tomography Scans
                                        Effective for Services on or
                                        after July 1, 1999.
                                       Expanded Coverage of Positron
                                        Emissions Tomography Scans
                                        Effective for Services on or
                                        after July 1, 2001.
                                       Expanded Coverage of Positron
                                        Emissions Tomography Scans for
                                        Breast Cancer Effective for
                                        Dates on or after October 1,
                                        2002.
                                       Coverage of Positron Emissions
                                        Tomography Scans for Myocardial
                                        Viability.
                                       Coverage of Positron Emissions
                                        Tomography Scans for Thyroid
                                        Cancer.
                                       Coverage of Positron Emissions
                                        Tomography Scans for Perfusion
                                        of the Heart Using Ammonia N-13.
224..................................  October Quarterly Update to 2004
                                        Annual Update of Health Common
                                        Procedure Coding System Codes
                                        Used For Skilled Nursing
                                        Facility.
                                       Consolidated Billing Enforcement.
225..................................  Changes to the Laboratory
                                        National Coverage Determination
                                        Edit Software for October 2004.
226..................................  Quarterly Update of Health Common
                                        Procedure Coding System Codes
                                        Used for Home Health
                                        Consolidated Billing
                                        Enforcement.
                                       Home Health Prospective Payment
                                        System Consolidated Billing and
                                        Primary Home Health Agency.
227..................................  Local Medical Review Policy/Local
                                        Coverage Determination Medicare.
                                       Summary Notice Message Revision.
                                       Medical Necessity.
                                       Necesidad M[eacute]dica.
228..................................  General Policy.
                                       Patient and Insured Information.
229..................................  Additional Clarification of Bill
                                        Type 22x and 23x Submitted by
                                        Skilled Nursing Facilities With
                                        Instructions for Involuntarily
                                        Moving A Beneficiary Out of the
                                        Skilled Nursing Facility and
                                        Ending a Benefit Period.
                                       Skilled Nursing Facility
                                        Prospective Payment System and
                                        Consolidated Billing Overview.
                                       Consolidated Billing Requirements
                                        for Skilled Nursing Facility.
                                       Other Excluded Services Beyond
                                        the Scope of a Skilled Nursing
                                        Facility Part A Benefit.
                                       Outpatient Surgery and Related
                                        Procedures `` Inclusions.
                                       Emergency Services.
                                       Dialysis and Dialysis Related
                                        Services to a Beneficiary With
                                        End Stage Renal Disease.
                                       End Stage Renal Disease Services.
                                       Coding Applicable to Epoetin
                                        Services.
                                       Coding for Darbepoetin Alfa.
                                       Ambulance Services.
                                       Screening and Preventive
                                        Services.
                                       Therapy Services.
                                       Situations that Require a
                                        Discharge or Leave of Absence.
                                       Billing Procedures for Periodic
                                        Interim Payment Method of
                                        Payment Ending A Benefit Period.
                                       Other Billing Situations.
                                       Billing for Outpatient Skilled
                                        Nursing Facility Services
230..................................  Update to the Claims Status
                                        Codes.
                                       Health Care Claims Status
                                        Category Codes and Health Care
                                        Claims Status Codes for Use with
                                        Health Care Claims Status
                                        Request and Response.
231..................................  Indian Health Service or Tribal
                                        Critical Access Hospital Payment
                                        Methodology for Inpatient and
                                        Outpatient Services.
                                       Payment for Inpatient Services
                                        Furnished by an Indian Health
                                        Service or Tribal Critical
                                        Access Hospital.
                                       Payment for Outpatient Services
                                        Furnished by an Indian Health
                                        Service or Tribal Critical
                                        Access Hopsital.
232..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
233..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
234..................................  Standardized Responses to
                                        Provider Inquiries Regarding the
                                        Negotiated Laboratory National
                                        Coverage Determinations Edit
                                        Software.
235..................................  Instructions for Downloading the
                                        Medicare Zip Code File.
236..................................  2005 Durable Medical Equipment
                                        Prosthetic, Orthotics & Supplies
                                        Pricing.
                                       File Record Layout Expansion and
                                        New Pricing Procedures for
                                        Certain Durable Medical
                                        Equipment Prosthetic, Orthotics
                                        & Supplies Items Based on
                                        Modifiers.
                                       Payment of Durable Medical
                                        Equipment Prosthetic, Orhtotics
                                        & Supplies Items based on
                                        Modifiers.
                                       Intermediary Format for Durable
                                        Medical Equipment, Prosthetic,
                                        Orthotic and Supply Fee
                                        Schedule.
237..................................  Implementation of Patient Status
                                        Code 65, Discharged/Transferred
                                        to a Psychiatric Hospital or
                                        Psychiatric Distinct Part Unit
                                        of a Hospital.
238..................................  Health Insurance Portability and
                                        Accountability Act Institutional
                                        Health Care Claim Implementation
                                        Guide Additional Updates.
239..................................  Transmittal 239 is Rescinded and
                                        replaced with Transmittal 270.
240..................................  Expansion of the Existing
                                        Interrupted Stay Policy Under
                                        Long Term Care.
                                       Hospital Prospective Payment
                                        System.
241..................................  Processing Part B Claims for
                                        Indian Health Services.
                                       General.
                                       Services That May Be Paid to
                                        Indian Health Service/Tribe/
                                        Tribal Organization Facilities.

[[Page 78433]]

 
                                       Services Paid Under the Physician
                                        Fee Schedule.
                                       Other Part B Services.
                                       Durable Medical Equipment.
                                       Prosthetics and Orthotics.
                                       Prosthetics Devices.
                                       Surgical Dressings and Splints
                                        and Casts.
                                       Therapeutic Shoes.
                                       Drugs.
                                       Clinical Laboratory Services.
                                       Ambulance Services.
                                       Claims Processing.
                                       Claims Processing Requirements
                                        for Benefits, Improvements &
                                        Protection Act of 2000 Services.
                                       Claims Processing Requirements
                                        for Medicare Modernization Act
                                        Enrollment and Billing for
                                        Durable Medical Equipment,
                                        Prosthetic, Orthotics &
                                        Supplies.
                                       Claims Processing for Durable
                                        Medical Equipment, Prosthetic,
                                        Orthotics & Supplies.
                                       Enrollment for Durable Medical
                                        Equipment, Prosthetic, Orthotics
                                        & Supplies.
                                       Claims Submission for Durable
                                        Medical Equipment, Prosthetic,
                                        Orthotics & Supplies.
                                       Enrollment and Billing for
                                        Clinical Laboratory and
                                        Ambulance Services Claims
                                        Submission and Processing for
                                        Clinical Laboratory and
                                        Ambulance Service.
                                       Enrollment for Clinical
                                        Laboratory and Ambulance
                                        Services and Part B drugs.
242..................................  Quarterly Update to Correct
                                        Coding Initiative edits, Version
                                        10.3, Effective October 1, 2004.
243..................................  Patient Status Code and Reason
                                        for Patient Visit for the
                                        Hospital Outpatient Prospective
                                        Payment System.
                                       Patient Status Code and Reason
                                        for Patient Visit for the
                                        Hospital.
244..................................  Transmittal 244 is Rescinded and
                                        Replaced with Transmittal 269.
245..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
246..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
247..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
248..................................  Durable Medical Equipment
                                        Regional Carrier/Local Carriers/
                                        Statistical Analysis Durable
                                        Medical Equipment Regional
                                        Carrier--Drug Pricing Limits as
                                        of January 1, 2005.
                                       Payment Rules for Drugs and
                                        Biologicals.
                                       Medicare Modernization Act Drug
                                        Pricing-Average Sales Price.
                                       Single Drug Pricer.
                                       Calculation of the Payment
                                        Allowance Limit for Durable
                                        Medical Equipment.
                                       Regional Carrier Drugs.
                                       Calculation of the Average
                                        Wholesale Price.
                                       Detailed Procedures for
                                        Determining Average Wholesale
                                        Price and the Drug.
                                       Payment Allowance Limits.
                                       Background.
                                       Review of Sources for Medicare
                                        Covered Drugs and Biologicals.
                                       Use of Generics.
                                       Find the Strength and Dosage.
                                       Restrictions.
                                       Inherent Reasonableness for Drugs
                                        and Biologicals.
                                       Injection Services.
                                       Injections Furnished to End Stage
                                        Renal Disease Beneficiaries.
249..................................  New Medicare Summary Notice
                                        Message 31.18.
                                       Adjustments.
                                       Ajustes.
250..................................  Coordination of Benefits
                                        Agreement Claims Selection
                                        Options.
                                       Consolidated Claims Crossover
                                        Process.
                                       Consolidation of the Claims
                                        Crossover Process.
251..................................  Editing Of Hospital And Skilled
                                        Nursing Facility Part B
                                        Inpatient Services.
                                       Inpatient Part B Hospital
                                        Services.
                                       Editing of Hospital Part B
                                        Inpatient Services. Billing for
                                        Inpatient Skilled Nursing
                                        Facility Services Paid Under
                                        Part B.
                                       Editing of Skilled Nursing
                                        Facilities Part B Inpatient
                                        Services.
252..................................  Paper Remittance Advice format
                                        change to accommodate the forced
                                        balancing Amount to balance at
                                        the claim level as well as the
                                        provider level, a flat file
                                        change, and a change in the
                                        companion document for fiscal
                                        intermediaries.
253..................................  Fiscal Intermediary Shared System
                                        Changes to Allow for Provider
                                        Liability Days on Skilled
                                        Nursing Facility and Swing Bed
                                        Facility Inpatient Bills.
                                       Billing Skilled Nursing Facility
                                        Prospective Payment System
                                        Services.
254..................................  October 2004 Outpatient
                                        Prospective Payment System Code
                                        Editor Specifications Version
                                        5.3.
255..................................  October Update to the Medicare
                                        Outpatient Code Editor Version
                                        20.0 for Bills From Hospitals
                                        That Are Not Paid Under the
                                        Outpatient Prospective Payment
                                        System.
256..................................  Use of Group Health Plan Payment
                                        System/Medicare Managed Care
                                        System To Pay Capitated Payments
                                        to Chronic Care Improvement
                                        Organizations Serving Medicare
                                        Fee-For-Service Beneficiaries
                                        Under Section 721 of the
                                        Medicare Modernization Act.
257..................................  Shared Systems Changes for
                                        Medicare Part B Drugs for End
                                        Stage Renal Disease Independent
                                        Dialysis Facilities.
258..................................  New Waived Tests--October 1,
                                        2004.
259..................................  Scheduled Release for October
                                        Updates to Software Programs and
                                        Pricing/Coding Files.
260..................................  Cryosurgery of the Prostate.
                                       Cryosurgery of the Prostate
                                        Gland.
                                       Coverage Requirements.

[[Page 78434]]

 
                                       Billing Requirements.
                                       Payment Requirements.
261..................................  Billing and Requirements for
                                        Islet Cell Transplantation for
                                        Beneficiaries in a National
                                        Institutes of Health Clinical
                                        Trial.
                                       Billing Requirements for Islet
                                        Cell Transplantation for
                                        Beneficiaries in a National
                                        Institutes of Health Clinical
                                        Trial.
                                       Healthcare Common Procedural
                                        Coding System Codes for
                                        Carriers.
                                       Applicable Modifier for Islet
                                        Cell Transplant Claims for
                                        Carriers.
                                       Special Billing and Payment
                                        Requirements for Carriers.
                                       Special Billing and Payment
                                        Requirements for Intermediaries.
                                       Special Billing and Payment
                                        Requirements Medicare Advantage
                                        Beneficiaries.
262..................................  Confidential.
263..................................  Inpatient Rehabilitation Facility
                                        Annual Update: Prospective
                                        Payment System.
                                       Pricer Changes for Fiscal Year
                                        2005.
                                       Outlier Payments: Cost-to-Charge
                                        Ratios.
264..................................  This Transmittal is Rescinded and
                                        Replaced with Transmittal 271.
265..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
266..................................  Revision of Common Working File
                                        Editing for Same-Day, Same-
                                        Provider Acute Care
                                        Readmissions.
                                       Repeat Admissions.
267..................................  Crossover Patients in New Long
                                        Term Care Hospital.
                                       Billing Procedures for a Provider
                                        Assigned Multiple Provider
                                        Numbers or a Change in Provider
                                        Number.
                                       Crossover Patients in New Long
                                        Term Care Hospital.
268..................................  Medicare Part A Skilled Nursing
                                        Facility Prospective Payment.
                                       System Pricer Update Fiscal Year
                                        2005.
                                       Skilled Nursing Facility
                                        Prospective Payment System
                                        Pricer Software.
269..................................  This Transmittal Replaces
                                        Transmittal 244.
270..................................  This Transmittal Replaces
                                        Transmittal 239.
271..................................  This Transmittal Replaces
                                        Transmittal 264.
272..................................  October Quarterly Update for 2004
                                        Durable Medical Equipment,
                                        Prosthetics, Orthotics, and
                                        Supplies Fee Schedule.
273..................................  Modification of CMS' Medicare
                                        Contingency Plan for Health
                                        Insurance Portability &
                                        Accountability Act
                                        Implementation.
                                       Receipt Date.
                                       Payment Ceiling Standards.
                                       Payment Floor Standards.
                                       Determining and Paying Interest.
274..................................  Good Cause Waiver of Late Claim
                                        Filing Payment Reduction
                                        Penalty.
                                       Extend Time for Good Cause.
                                       Conditions Which Establish Good
                                        Cause.
                                       Procedure to Establish Good
                                        Cause.
                                       Good Cause Is Not Found.
                                       Preparing Common Working File
                                        Claim Records for Services
                                        Subject to 10 Percent Payment
                                        Reduction.
275..................................  The Supplemental Security Income/
                                        Medicare Beneficiary Data for
                                        Fiscal Year 2003 for Inpatient
                                        Prospective Payment System
                                        Hospitals.
276..................................  Further Information Related to CR
                                        3175, Distinct Part Units of
                                        Critical Access Hospitals.
                                       Requirements for Critical Access
                                        Hospital Services, Critical
                                        Access Hospital Skilled Nursing
                                        Care Services and Distinct Part
                                        Units.
                                       Inpatient Rehabilitation Facility
                                        Prospective Payment System.
                                       Billing Requirements Under
                                        Inpatient Rehabilitation
                                        Facility Prospective Payment
                                        System.
277..................................  Sensitive.
278..................................  This Transmittal is no longer
                                        sensitive and can be posted to
                                        Internet/Intranet.
279..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to sensitivity of
                                        instruction.
280..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to sensitivity of
                                        instruction.
281..................................  Issued to a specific audience,
                                        not posted to Internet/Intranet
                                        due to confidentiality of
                                        instruction.
282..................................  This Transmittal replaces
                                        Transmittal 274.
283..................................  2005 Healthcare Common Procedure
                                        Coding System Annual Update
                                        Reminder.
                                       Health Care Common Procedure
                                        Coding System Annual Update
                                        Reminder.
284..................................  Durable Medical Equipment
                                        Regional Carriers Only--Appeals
                                        of Duplicate Claims.
285..................................  Addition of Physician Assistants,
                                        Nurse Practitioners and Clinical
                                        Nurse.
                                       Specialists as Emergency On-Call
                                        Providers for Critical Access
                                        Hospitals.
                                       Costs of Emergency Room On-Call
                                        Providers.
286..................................  Medicare Physician Fee Schedule
                                        Database 2005 File Layout.
                                       Addendum.
287..................................  Schedule for Completing the
                                        Calendar Year 2005 Fee Schedule
                                        Updates and the Participating
                                        Physician Enrollment Procedures.
288..................................  Fiscal Year 2005 Payment for
                                        Services Furnished in Ambulatory
                                        Surgical Centers.
289..................................  File Descriptions and
                                        Instructions for Retrieving the
                                        2005 Pricing Files Through CMS''
                                        Mainframe Telecommunications
                                        System.
                                       Recurring Update Notification
                                        Containing New Pricing File
                                        Names and Retrieval Dates for
                                        2005.
290..................................  October 2004 Update of the
                                        Hospital Outpatient Prospective
                                        Payment System.
291..................................  Use of Transmission Date in the
                                        Service Date/Assessment Date
                                        Field for Inpatient
                                        Rehabilitation Facility
                                        Prospective Payment System
                                        Claims.
                                       Payment Adjustment for Late
                                        Transmission of Patient
                                        Assessment Data.
292..................................  Confidential.
293..................................  Confidential.
294..................................  Sensitive/Controversial.

[[Page 78435]]

 
295..................................  Transmittal 214 is Rescinded and
                                        Replaced with Transmittal 295.
296..................................  This Transmittal replaces
                                        Transmittal 196.
297..................................  Reasonable Charge Update for 2005
                                        for Splints, Casts, Dialysis
                                        Supplies, Dialysis Equipment,
                                        Therapeutic Shoes, and Certain
                                        Intraocular Lenses.
298..................................  This Transmittal replaces
                                        Transmittal 295.
299..................................  Use of Condition Code 44,
                                        ``Inpatient Admission Changed to
                                        Outpatient''.
300..................................  Payment For Outpatient End Stage
                                        Renal Disease-Related Services.
301..................................  Transmittal 301 Replaces
                                        Transmittal 251.
302..................................  Nursing Facility Visits (Codes
                                        99301-99313).
303..................................  Instructions for Completion of
                                        Form CMS-1450.
304..................................  Transmittal 304 Replaces
                                        Transmittal 205.
--------------------------------------
               Medicare Secondary Payer (CMS-Pub. 100-05)
------------------------------------------------------------------------
17...................................  Clarification of CR 3064.
                                       General Policy.
18...................................  Application of the Medicare
                                        Secondary Payer for the Working
                                        Aged Provision and the Medicare
                                        Secondary for the Disabled
                                        Provision to Former Spouses and
                                        Certain Family Members With
                                        Coverage Under the Federal
                                        Employees Health Benefits
                                        Program.
                                       Individuals Not Subject to the
                                        Limitation on Payment.
                                       Individuals Not Subject to
                                        Medicare Secondary Payer
                                        Provision.
19...................................  Clarification of Medicare
                                        Secondary Payer Rules in
                                        Relation to a Temporary Leave of
                                        Absence.
                                       Rules Defining Employees Covered
                                        by Group Health Plans and Large
                                        Group Health Plans.
--------------------------------------
             Medicare Financial Management (CMS-Pub. 100-06)
------------------------------------------------------------------------
49...................................  Procedures For Re-Issuance and
                                        Stale Dating of Medicare Checks
50...................................  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.
51...................................  This transmittal is rescinded and
                                        replaced with Transmittal 52.
52...................................  Notice of New Interest Rate for
                                        Medicare Overpayments and
                                        Underpayments.
53...................................  Change Request 3367, Debt
                                        Collection System, replaces
                                        Change Request 2952, Debt
                                        Collection System
54...................................  Notification to Providers of
                                        Intent to Complete a Post-
                                        Payment Audit.
                                       Contractor's Responsibility Prior
                                        to Submission of Cost Reports.
--------------------------------------
             Medicare State Operations Manual (Pub. 100-07)
------------------------------------------------------------------------
02...................................  Provider Identification Number.
--------------------------------------
              Medicare Program Integrity (CMS-Pub. 100-08)
------------------------------------------------------------------------
79...................................  Local Medical Review Policy/Local
                                        Coverage Determination Medicare
                                        Summary.
                                       Notice Message Revision.
                                       Prepayment Edits.
80...................................  Program Integrity Management
                                        Fraud and Abuse Complaint
                                        Screening Revisions. Complaint
                                        Screening.
81...................................  Implementation of the Quarterly
                                        Strategy Analysis.
                                       The Quarterly Strategy Analysis.
                                       The Quarterly Strategy Analysis
                                        Format.
                                       Executive Summary.
                                       Problem Specific Activities.
                                       Problem Specific Activity
                                        Definitions.
                                       Narrative.
82...................................  Home Health Demand Bills.
                                       Home Health.
                                       Effectuating Favorable Final
                                        Appellate.
                                       Decisions That a Beneficiary Is
                                        ``Confined to Home'' .
                                       Medical Review of Home Health
                                        Demand Bills.
83...................................  Program Integrity Management
                                        Revisions for Chapter 4.
                                       Program Safeguard Contractor and
                                        Medicare Contractor Benefit
                                        Integrity Unit.
                                       Benefit Integrity Security
                                        Requirements.
                                       Medical Review for Benefit
                                        Integrity Purposes.
                                       Requests for Information from
                                        Outside Organizations.
                                       Conducting Investigations.
                                       Disposition of Cases.
                                       Types of Fraud Alerts.
                                       Background.
                                       Investigation, Case, and
                                        Suspension Entries.
                                       Initial Entry Requirements for
                                        Investigations.
                                       Referral of Cases to the Office
                                        of the Inspector General/Office
                                        of Investigations.

[[Page 78436]]

 
                                       Suspension.
                                       Referral to Quality Improvement
                                        Organizations
                                       Exceptions.
--------------------------------------
  Medicare Contractor Beneficiary and Provider Communications (CMS-Pub.
                                 100-09)
------------------------------------------------------------------------
07...................................  Confidential.
--------------------------------------
                 Medicare Managed Care (CMS-Pub. 100-16)
------------------------------------------------------------------------
56...................................  Administrative Contracting
                                        Requirements.
57...................................  Coverage of Clinical Trials.
                                       Hospital Inpatient Data.
                                       Diagnostic Coding and Guidelines
                                        for Data Collection From
                                        Provider Network.
58...................................  Terminology.
59...................................  State and County Code
                                        Corrections.
                                       Completion of Enrollment Form.
                                       Passive Elections.
                                       Eligibility Requirements for
                                        Medicare Medical Savings Account
                                        Plans.
                                       Annual Elective Period.
                                       Open Enrollment Period.
                                       Open Enrollment Period Through
                                        2005.
                                       Open Enrollment Period in 2006.
                                       Open Enrollment Period in 2007
                                        and Beyond.
                                       Open Enrollment for Newly
                                        Eligible Individuals in 2006 and
                                        Beyond.
                                       Open Enrollment Period for
                                        Institutionalized Individuals in
                                        2006 and Beyond.
                                       Special Enrollment Period for
                                        Beneficiaries Age 65.
60...................................  Streamlined Marketing Review
                                        Process.
                                       File and Use.
                                       Guidelines for Advertising and
                                        Pre-Enrollment Materials.
                                       Guidelines for Advertising
                                        Materials.
                                       Guidelines for Pre-Enrollment
                                        Materials.
61...................................  Emergency and Urgently Needed
                                        Services.
62...................................  Revisions to Chapter 13--
                                        Medicare+Choice Beneficiary
                                        Grievances, Organization
                                        Determinations and Appeals.
--------------------------------------
                    Demonstrations (CMS-Pub. 100-19)
------------------------------------------------------------------------
05...................................  Use of Group Health Plan Payment
                                        System to Pay Capitated Payments
                                        to Non-Health Plan Demonstration/
                                        Program Sites Serving Medicare
                                        Fee For Service Beneficiaries--
                                        Updated List of Plan Numbers.
06...................................  Revision of CR 3269 for the
                                        Demonstration Project to Clarify
                                        the Definition of Homebound
                                        (Homebound Demonstration).
--------------------------------------
                 One Time Notification (CMS-Pub. 100-20)
------------------------------------------------------------------------
92...................................  Additional Instructions Related
                                        to the ``Redistribution of
                                        Unused Resident Positions,''
                                        Section 422 of the Medicare
                                        Modernization Act of 2003 P.L.
                                        108-173, for Purposes of
                                        Graduate Medical Education
                                        Payments.
93...................................  Temporary Skilled Nursing
                                        Facility Extension.
94...................................  Shared System Maintainer Hours
                                        for Resolution of Problems
                                        Detected During Health Insurance
                                        Portability and Accountability
                                        Act.
                                       Transaction Release Testing.
95...................................  Modifications to Post-payment
                                        Adjustment Process for Home
                                        Health Prospective Payment
                                        System Claims Failing to Report
                                        Prior Inpatient Discharges.
96...................................  Annual Changes to the Amount in
                                        Controversy Thresholds For the
                                        Administrative Law Judge and
                                        Judicial Review.
                                       Levels of the Claim Appeals
                                        Process as Required by Section
                                        940 of the Medicare Prescription
                                        Drug, Improvement, and
                                        Modernization Act of 2003.
97...................................  Implementation of the Business
                                        Segment Identifier in the
                                        Healthcare Integrated General
                                        Ledger Accounting System.
98...................................  Change to Previous Transmittal
                                        Regarding the Discounted Use of
                                        Revenue Code 0910.
99...................................  This One-Time Notification is a
                                        full replacement for Transmittal
                                        86.
100..................................  This Transmittal is Rescinded and
                                        Replaced with Transmittal 103.
101..................................  Change of the Premera Blue Cross
                                        Medicare Part A Plan Under
                                        Contract to BCBSA to a Part A
                                        Fiscal Intermediary Contract
                                        with Noridian Mutual Insurance
                                        Company in the States of
                                        Washington and Alaska.
102..................................  Update to the Healthcare Provider
                                        Taxonomy Codes/Medicare
                                        Specialty Code Crosswalk.
103..................................  This Transmittal replaces
                                        Transmittal 100.
104..................................  Confidential.
105..................................  Confidential.
106..................................  Medicare Modernization Act Drug
                                        Pricing Update-Payment Limits
                                        for J9045 (Carboplatin
                                        Injection) and (Rituximab Cancer
                                        Treatment).
107..................................  Common Working File Analysis to
                                        Process Claims Per the Renovated
                                        Override Code Processing (re:
                                        CR3190) and Common Working File
                                        Analysis to Review System Edits
                                        for Additional 2-byte Modifiers
                                        Added in CR3190 (Phase 2).
108..................................  New Remark Code Message for Use
                                        With Claims for Parental Pumps-
                                        Durable Medical Equipment
                                        Regional Carrier Only.
109..................................  Billing Instructions for ADVATE
                                        rAHF-PFM on Medicare Claims.
110..................................  Medicare Modernization Act Drug
                                        Pricing Update-Payment Limits
                                        for J100 (Depo-estradiol
                                        cypionate inj).
111..................................  Creation of Common Working File
                                        Auxilliary File and Associated
                                        Logic to Property.

[[Page 78437]]

 
                                       Calculate Medicare-Equivalent
                                        Deductibles for Department of
                                        Veteran Affairs Claims.
112..................................  This Transmittal replaces
                                        Transmittal 109.
113..................................  Implementation of Sec.   921 of
                                        the Medicare Modernization Act
                                        Provider Customer Program.
114..................................  Sensitive.
115..................................  Instructions for Fiscal
                                        Intermediary Standard System and
                                        Multi-Carrier System Healthcare
                                        Integrated General Ledger
                                        Accounting System Changes.
116..................................  Notification of Medlearn Matters
                                        Article for Confidential Change
                                        Request (CR) 3301.
------------------------------------------------------------------------


                                          Addendum IV.--Regulation Documents Published in the Federal Register
                                                           [July 2004 Through September 2004]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       FR Vol. 69
          Publication date              page No.                CFR parts affected                      File code               Title of regulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 1, 2004........................        40288  42 CFR Part 414............................  CMS-1492-IFC               Medicare Program; Medicare
                                                                                                                            Ambulance MMA Temporary Rate
                                                                                                                            Increases Beginning July 1,
                                                                                                                            2004.
July 23, 2004.......................        44036  ...........................................  CMS-1334-N                 Medicare Program; Public
                                                                                                                            Meeting in Calendar Year
                                                                                                                            2004 for Coding and Payment
                                                                                                                            Determinations for Power
                                                                                                                            Wheelchairs.
July 23, 2004.......................        44035  ...........................................  CMS-1364-N                 Medicare Program; August 30,
                                                                                                                            2004, Meeting of the
                                                                                                                            Practicing Physicians
                                                                                                                            Advisory Council and Request
                                                                                                                            for Nominations.
July 23, 2004.......................        44034  ...........................................  CMS-4074-N                 Medicare Program; Meeting of
                                                                                                                            the Advisory Panel on
                                                                                                                            Medicare Education--
                                                                                                                            September 9, 2004.
July 23, 2004.......................        44031  ...........................................  CMS-3142-NC                Medicare Program; Evaluation
                                                                                                                            Criteria and Standards for
                                                                                                                            Quality Improvement Program
                                                                                                                            Contracts.
July 23, 2004.......................        44029  ...........................................  CMS-3112-NC2               Medicare Program; Adjustment
                                                                                                                            in Payment Amounts for New
                                                                                                                            Technology Intraocular
                                                                                                                            Lenses Furnished by
                                                                                                                            Ambulatory Surgical Centers.
July 23, 2004.......................        44027  ...........................................  CMS-2202-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            American Association for
                                                                                                                            Accreditation of Ambulatory
                                                                                                                            Surgery Facilities, Inc.,
                                                                                                                            for Continued Deeming
                                                                                                                            Authority for Ambulatory
                                                                                                                            Surgical Centers.
July 23, 2004.......................        44013  ...........................................  CMS-2187-N                 State Children's Health
                                                                                                                            Insurance Program (SCHIP);
                                                                                                                            Extended Availability of
                                                                                                                            Unexpended SCHIP Funds From
                                                                                                                            the Appropriation for Fiscal
                                                                                                                            Years 1998 Through 2001; and
                                                                                                                            Provision of Authority for
                                                                                                                            Qualifying States To Use a
                                                                                                                            Portion of SCHIP Funds for
                                                                                                                            Medicaid Expenditures.
July 23, 2004.......................        43956  42 CFR Part 402............................  CMS-6146-P                 Medicare Program; Revised
                                                                                                                            Civil Money Penalties,
                                                                                                                            Assessments, Exclusions, and
                                                                                                                            Related Appeals Procedures.
July 23, 2004.......................        43926  45 CFR Part 146............................  CMS-2033-F                 Requirements for the Group
                                                                                                                            Health Insurance Market; Non-
                                                                                                                            Federal Governmental Plans
                                                                                                                            Exempt From HIPAA Title I
                                                                                                                            Requirements.
July 23, 2004.......................        43924  45 CFR Part 146............................  CMS-2152-F2                Amendment to the Interim
                                                                                                                            Final Regulation for Mental
                                                                                                                            Health Parity.
July 30, 2004.......................        45822  ...........................................  CMS-4068-N                 Medicare Program; Open Public
                                                                                                                            Meeting Regarding the
                                                                                                                            Development of the Model
                                                                                                                            Guidelines for Categories
                                                                                                                            and Classes of Drugs.
July 30, 2004.......................        45775  ...........................................  CMS-1249-N                 Medicare Program; Prospective
                                                                                                                            Payment System and
                                                                                                                            Consolidated Billing for
                                                                                                                            Skilled Nursing Facilities--
                                                                                                                            Update.
July 30, 2004.......................        45721  ...........................................  CMS-1360-N                 Medicare Program; Inpatient
                                                                                                                            Rehabilitation Facility
                                                                                                                            Prospective Payment System
                                                                                                                            for Fiscal Year 2005.
July 30, 2004.......................        45640  42 CFR Part 484............................  CMS-1265-CN                Medicare Program; Home Health
                                                                                                                            Prospective Payment System
                                                                                                                            Rate Update for Calendar
                                                                                                                            Year 2005; Correction
                                                                                                                            Notice.
July 30, 2004.......................        45604  42 CFR Parts 405 and 411...................  CMS-6014-F                 Medicare Program; Interest
                                                                                                                            Calculation.
August 3, 2004......................        46866  42 CFR Parts 417 and 422...................  CMS-4069-P                 Medicare Program;
                                                                                                                            Establishment of the
                                                                                                                            Medicare Advantage Program.
August 3, 2004......................        46632  42 CFR Parts 403, 411, 417, and 423........  CMS-4068-P                 Medicare Program; Medicare
                                                                                                                            Prescription Drug Benefit.
August 5, 2004......................        47488  42 CFR Parts 405, 410, 411, 414, 418, 424,   CMS-1429-P                 Medicare Program; Revisions
                                                    484, and 486.                                                           to Payment Policies Under
                                                                                                                            the Physician Fee Schedule
                                                                                                                            for Calendar Year 2005.
August 5, 2004......................        47446  ...........................................  CMS-1275-N                 Medicare Program; Meeting of
                                                                                                                            the Advisory Panel on
                                                                                                                            Ambulatory Payment
                                                                                                                            Classification Groups--
                                                                                                                            September 1, 2, and 3, 2004.

[[Page 78438]]

 
August 11, 2004.....................        48916  42 CFR Parts 403, 412, 413, 418, 460, 480,   CMS-1428-F                 Medicare Program; Changes to
                                                    482, 483, 485, and 489.                                                 the Hospital Inpatient
                                                                                                                            Prospective Payment Systems
                                                                                                                            and Fiscal Year 2005 Rates.
August 16, 2004.....................        50448  42 CFR Parts 410, 411, 419.................  CMS-1427-P                 Medicare Program; Proposed
                                                                                                                            Changes to the Hospital
                                                                                                                            Outpatient and Prospective
                                                                                                                            Payment System and Calendar
                                                                                                                            Year 2005 Payment Rates.
August 27, 2004.....................        52723  ...........................................  CMS-1279-N2                Medicare Program; Public
                                                                                                                            Meeting of the Program
                                                                                                                            Advisory and Oversight
                                                                                                                            Committee (PAOC) for Quality
                                                                                                                            Standards and Competitive
                                                                                                                            Acquisition of Certain
                                                                                                                            Durable Medical Equipment,
                                                                                                                            Prosthetics, Orthotics, and
                                                                                                                            Supplies (DMEPOS).
August 27, 2004.....................        52722  ...........................................  CMS-3136-N                 Medicare Program; Meeting of
                                                                                                                            the Medicare Coverage
                                                                                                                            Advisory Committee--
                                                                                                                            September 28, 2004.
August 27, 2004.....................        52721  ...........................................  CMS-5025-CN                Medicare Program; Medicare
                                                                                                                            Replacement Drug
                                                                                                                            Demonstration; Correction.
August 27, 2004.....................        52710  ...........................................  CMS-1264-N                 Medicare Program; Hospice
                                                                                                                            Wage Index for Fiscal Year
                                                                                                                            2005.
August 27, 2004.....................        52706  ...........................................  CMS-4067-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            Utilization Review
                                                                                                                            Accreditation Commission
                                                                                                                            (URAC) for Deeming Authority
                                                                                                                            for Medicare Advantage.
August 27, 2004.....................        52700  ...........................................  CMS-2201-N                 State Children's Health
                                                                                                                            Insurance Program; Final
                                                                                                                            Allotments to States, the
                                                                                                                            District of Columbia, and
                                                                                                                            U.S. Territories and
                                                                                                                            Commonwealths for Fiscal
                                                                                                                            Year 2005.
August 27, 2004.....................        52699  ...........................................  CMS-1269-N2                Medicare Program; Second
                                                                                                                            Request for Nominations for
                                                                                                                            Two Specific Categories of
                                                                                                                            Members of the Emergency
                                                                                                                            Medical Treatment and Labor
                                                                                                                            Act (EMTALA) Technical
                                                                                                                            Advisory Group (TAG).
August 27, 2004.....................        52620  42 CFR Parts 431 and 457...................  CMS-6026-P                 Medicaid Program and State
                                                                                                                            Children's Health Insurance
                                                                                                                            Program (SCHIP): Payment
                                                                                                                            Error Rate Measurement.
August 27, 2004.....................        52620  42 CFR Part 402............................  CMS-6146-CN                Medicare Program; Revised
                                                                                                                            Civil Money Penalties,
                                                                                                                            Assessments, Exclusions, and
                                                                                                                            Related Appeals Procedures.
September 9, 2004...................        54674  ...........................................  CMS-8020-N                 Medicare Program; Medicare
                                                                                                                            Part B Monthly Actuarial
                                                                                                                            Rates, Premium Rate, and
                                                                                                                            Annual Deductible Beginning
                                                                                                                            January 1, 2005.
September 9, 2004...................        54673  ...........................................  CMS-8022-N                 Medicare Program; Part A
                                                                                                                            Premium for 2005 for the
                                                                                                                            Uninsured Aged and for
                                                                                                                            Certain Disabled Individuals
                                                                                                                            Who Have Exhausted Other
                                                                                                                            Entitlement, Thursday,
                                                                                                                            September 9, 2004.
September 9, 2004...................        54671  ...........................................  CMS-8021-N                 Medicare Program; Inpatient
                                                                                                                            Hospital Deductible and
                                                                                                                            Hospital and Extended Care
                                                                                                                            Services Coinsurance Amounts
                                                                                                                            for 2005, Thursday,
                                                                                                                            September 9, 2004.
September 14, 2004..................        55440  ...........................................  CMS-6027-N                 Medicare Program; September
                                                                                                                            30, 2004 Open Door Forum:
                                                                                                                            Requirements for
                                                                                                                            Coordination Between Plans
                                                                                                                            Primary or Secondary to
                                                                                                                            Medicare Part D Under the
                                                                                                                            Medicare Prescription Drug,
                                                                                                                            Improvement, and
                                                                                                                            Modernization Act of 2003
                                                                                                                            (MMA).
September 16, 2004..................        55763  42 CFR Part 414............................  CMS-1380-F                 Medicare Program;
                                                                                                                            Manufacturer Submission of
                                                                                                                            Manufacturer's Average Sales
                                                                                                                            Price (ASP) Data for
                                                                                                                            Medicare Part B Drugs and
                                                                                                                            Biologicals.
September 24, 2004..................        57325  ...........................................  CMS-3141-N                 Procedure for Producing
                                                                                                                            Guidance Documents
                                                                                                                            Describing Medicare's
                                                                                                                            Coverage Process.
September 24, 2004..................        57325  ...........................................  CMS-3137-N                 Medicare Program; Meeting of
                                                                                                                            the Medicare Coverage
                                                                                                                            Advisory Committee--November
                                                                                                                            4, 2004.
September 24, 2004..................        57324  ...........................................  CMS-2200-N4                Medicare Program; Meeting of
                                                                                                                            the State Pharmaceutical
                                                                                                                            Assistance Transition
                                                                                                                            Commission--October 14,
                                                                                                                            2004.
September 24, 2004..................        57312  ...........................................  CMS-9023-N                 Medicare and Medicaid
                                                                                                                            Programs; Quarterly Listing
                                                                                                                            of Program Issuances--April
                                                                                                                            2004 Through June 2004.
September 24, 2004..................        57310  ...........................................  CMS-4077-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            National Committee for
                                                                                                                            Quality Assurance Preferred
                                                                                                                            Provider Organization for
                                                                                                                            Deeming Authority for
                                                                                                                            Medicare Advantage.
September 24, 2004..................        57308  ...........................................  CMS-2208-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            American Osteopathic
                                                                                                                            Association for Continued
                                                                                                                            Approval of Deeming
                                                                                                                            Authority for Hospitals.
September 24, 2004..................        57307  ...........................................  CMS-2256-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            Community Health
                                                                                                                            Accreditation Program (CHAP)
                                                                                                                            for Home Health Agencies.

[[Page 78439]]

 
September 24, 2004..................        57305  ...........................................  CMS-2204-PN                Medicare and Medicaid
                                                                                                                            Programs; Application by the
                                                                                                                            Joint Commission on
                                                                                                                            Accreditation of Healthcare
                                                                                                                            Organizations (JCAHO) for
                                                                                                                            Home Health Agencies.
September 24, 2004..................        57304  ...........................................  CMS-3154-N                 Medicare Program; Request for
                                                                                                                            Nominations for Members for
                                                                                                                            the Medicare Coverage
                                                                                                                            Advisory Committee.
September 24, 2004..................        57244  42 CFR Parts 431 and 457...................  CMS-6026-CN                Medicaid Program and State
                                                                                                                            Children's Health Insurance
                                                                                                                            Program (SCHIP); Payment
                                                                                                                            Error Rate Measurement;
                                                                                                                            Correction.
September 24, 2004..................        57226  42 CFR Part 411............................  CMS-1810-IFC2              Medicare Program; Physicians'
                                                                                                                            Referrals to Health Care
                                                                                                                            Entities With Which They
                                                                                                                            Have Financial Relationships
                                                                                                                            (Phase II); Correcting
                                                                                                                            Amendment.
September 24, 2004..................        57224  42 CFR Part 406............................  CMS-4018-F                 Medicare Program;
                                                                                                                            Continuation of Medicare
                                                                                                                            Entitlement When Disability
                                                                                                                            Benefit Entitlement Ends
                                                                                                                            Because of Substantial
                                                                                                                            Gainful Activity.
September 24, 2004..................        57859  42 CFR Part 493............................  .........................  Laboratory Requirements; OFR
                                                                                                                            Correction.
September 30, 2004..................        58596  42 CFR Parts 431 and 457...................  CMS-6026-CN                Medicaid Program and State
                                                                                                                            Children's Health Insurance
                                                                                                                            Program (SCHIP); Payment
                                                                                                                            Error Rate Measurement; OFR
                                                                                                                            Correction.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Addendum V--National Coverage Determinations [July 2004 Through 
September 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 website at 
http://cms.hhs.gov/coverage.

                                        National Coverage Determinations
                                       [July 2004 Through September 2004]
----------------------------------------------------------------------------------------------------------------
                Title                     NCDM section           TN        Issue date    Effective date
----------------------------------------------------------------------------------------------------------------
Manualization of Negotiated Clinical  N/A.................  R17NCD..............      07/02/2004      07/02/2004
 Diagnostic Laboratory NCDs.
Changes to the Laboratory NCD Edit    N/A.................  R225CP..............      04/09/2004      10/04/2004
 Software for October 2004.
Blood-Derived Products for Chronic    270.3...............  R19NCD..............      07/30/2004      07/23/2004
 Non-Healing Wounds.
Islet Cell Transplantation..........  260.3.1.............  R18NCD..............      07/30/2004      10/04/2004
MRS for Diagnosing Brain Tumors.....  220.2.1.............  R21NCD..............      09/10/2004      09/10/2004
----------------------------------------------------------------------------------------------------------------

Addendum VI--FDA-Approved Category B IDEs

    Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices 
fall into one of three classes. To assist CMS under this categorization 
process, the FDA assigns one of two categories to each FDA-approved 
IDE. Category A refers to experimental IDEs, and Category B refers to 
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, July 2004 Through September 2004.
IDE Category
G030093
G030237
G040049
G040052
G040057
G040091
G040092
G040094
G040096
G040098
G040099
G040100
G040102
G040103
G040104
G040105
G040109
G040111
G040112
G040113
G040119
G040122
G040124
G040126
G040128
G040129
G040130
G040134
G040137
G040142
G040143
G040144
G040145
G040146
G040147
G040148
G040149
G040150

[[Page 78440]]

G040153
G040154
G040160
G980099

Addendum VII-Approval Numbers for Collections of Information

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

------------------------------------------------------------------------
                                     Approved CFR Sections in Title 42,
                                       Title 45, and Title 20 (Note:
       OMB control numbers          Sections in Title 45 are preceded by
                                    ``45 CFR,'' and sections in Title 20
                                        are preceded by ``20 CFR'')
------------------------------------------------------------------------
0938-0008........................  414.40, 424.32, 424.44
0938-0022........................  413.20, 413.24, 413.106
0938-0023........................  424.103
0938-0025........................  406.28, 407.27
0938-0027........................  486.100-486.110
0938-0033........................  405.807
0938-0035........................  407.40
0938-0037........................  413.20, 413.24
0938-0041........................  408.6, 408.22
0938-0042........................  410.40, 424.124
0938-0045........................  405.711
0938-0046........................  405.2133
0938-0050........................  413.20, 413.24
0938-0062........................  431.151, 435.1009, 440.220, 440.250,
                                    442.1, 442.10-442.16, 442.30,
                                    442.40, 442.42, 442.100-442.119,
                                    483.400-483.480, 488.332, 488.400,
                                    498.3-498.5
0938-0065........................  485.701-485.729
0938-0074........................  491.1-491.11
0938-0080........................  406.7, 406.13
0938-0086........................  420.200-420.206, 455.100-455.106
0938-0101........................  430.30
0938-0102........................  413.20, 413.24
0938-0107........................  413.20, 413.24
0938-0146........................  431.800-431.865
0938-0147........................  431.800-431.865
0938-0151........................  493.1405, 493.1411, 493.1417,
                                    493.1423, 493.1443, 493.1449,
                                    493.1455, 493.1461, 493.1469,
                                    493.1483, 493.1489
0938-0155........................  405.2470
0938-0170........................  493.1269-493.1285
0938-0193........................  430.10-430.20, 440.167
0938-0202........................  413.17, 413.20
0938-0214........................  411.25, 489.2, 489.20
0938-0236........................  413.20, 413.24
0938-0242........................  488.26, 442.30
0938-0245........................  407.10, 407.11
0938-0246........................  431.800-431.865
0938-0251........................  406.7
0938-0266........................  416.41, 416.47, 416.48, 416.83
0938-0267........................  410.65, 485.56, 485.58, 485.60,
                                    485.64, 485.66
0938-0269........................  412.116, 412.632, 413.64, 413.350,
                                    484.245
0938-0270........................  405.376
0938-0272........................  440.180, 441.300-441.305
0938-0273........................  485.701-485.729
0938-0279........................  424.5
0938-0287........................  447.31
0938-0296........................  413.170, 413.184
0938-0301........................  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........................  489.11, 489.20
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
0938-0358........................  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

[[Page 78441]]

 
0938-0444........................  1004.40, 1004.50, 1004.60, 1004.70
0938-0445........................  412.44, 412.46, 431.630, 456.654,
                                    466.71, 466.73, 466.74, 466.78
0938-0447........................  405.2133
0938-0448........................  405.2133, 45 CFR 5, 5b; 20 CFR Parts
                                    401, 422E
0938-0449........................  440.180, 441.300-441.310
0938-0454........................  424.20
0938-0456........................  412.105
0938-0463........................  413.20, 413.24, 413.106
0938-0467........................  431.17, 431.306, 435.910, 435.920,
                                    435.940-435.960
0938-0469........................  417.126, 422.502, 422.516
0938-0470........................  417.143, 417.800-417.840, 422.6
0938-0477........................  412.92
0938-0484........................  424.123
0938-0501........................  406.15
0938-0502........................  433.138
0938-0512........................  486.304, 486.306, 486.307
0938-0526........................  475.102, 475.103, 475.104, 475.105,
                                    475.106
0938-0534........................  410.38, 424.5
0938-0544........................  493.1-493.2001
0938-0564........................  411.32
0938-0565........................  411.20-411.206
0938-0566........................  411.404, 411.406, 411.408
0938-0573........................  412.230, 412.256
0938-0578........................  447.534
0938-0581........................  493.1-493.2001
0938-0599........................  493.1-493.2001
0938-0600........................  405.371, 405.378, 413.20
0938-0610........................  417.436, 417.801, 422.128, 430.12,
                                    431.20, 431.107, 434.28, 483.10,
                                    484.10, 489.102
0938-0612........................  493.801, 493.803, 493.1232, 493.1233,
                                    493.1234, 493.1235, 493.1236,
                                    493.1239, 493.1241, 493.1242,
                                    493.1249, 493.1251, 493.1252,
                                    493.1253, 493.1254, 493.1255,
                                    493.1256, 493.1261, 493.1262,
                                    493.1263, 493.1269, 493.1273,
                                    493.1274, 493.1278, 493.1283,
                                    493.1289, 493.1291, 493.1299
0938-0618........................  433.68, 433.74, 447.272
0938-0653........................  493.1771, 493.1773, 493.1777
0938-0657........................  405.2110, 405.2112
0938-0658........................  405.2110, 405.2112
0938-0667........................  482.12, 488.18, 489.20, 489.24
0938-0679........................  410.38
0938-0685........................  410.32, 410.71, 413.17, 424.57,
                                    424.73, 424.80, 440.30, 484.12
0938-0686........................  493.551-493.557
0938-0688........................  486.304, 486.306, 486.307, 486.310,
                                    486.316, 486.318, 486.325
0938-0690........................  488.4-488.9, 488.201
0938-0691........................  412.106
0938-0692........................  466.78, 489.20, 489.27
0938-0701........................  422.152
0938-0702........................  45 CFR 146.111, 146.115, 146.117,
                                    146.150, 146.152, 146.160, 146.180
0938-0703........................  45 CFR 148.120, 148.124, 148.126,
                                    148.128
0938-0714........................  411.370-411.389
0938-0717........................  424.57
0938-0721........................  410.33
0938-0723........................  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
0938-0786........................  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

[[Page 78442]]

 
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 and 491
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........................  411.352-411.361
0938-0857........................  419
0938-0860........................  419
0938-0866........................  45 CFR Part 162
0938-0872........................  413.337, 483.20
0938-0873........................  422.152
0938-0874........................  45 CFR Parts 160 and 162
0938-0878........................  422 Subpart F & G
0938-0883........................  45 CFR Parts 160 and 164
0938-0884........................  405.940
0938-0887........................  45 CFR 148.316, 148.318, 148.320
0938-0897........................  412.22, 412.533
0938-0907........................  412.230, 412.304, 413.65
0938-0910........................  422.624, 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
0938-0921........................  414.804
------------------------------------------------------------------------

[FR Doc. 04-28156 Filed 12-29-04; 8:45 am]
BILLING CODE 4120-01-P