Medicaid and Medicare: Program issuances and coverage decisions; quarterly listing,

[Federal Register: December 30, 2004 (Volume 69, Number 250)]

[Notices]

[Page 78428-78442]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30de04-79]

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

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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:

  1. 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.

  2. 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.

  3. How to Obtain Listed Material

    1. Manuals

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

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      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.

    2. 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).

    3. 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.

    4. 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.

  4. 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.

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    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.

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    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.

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    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.

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    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.

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    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.

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    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

    TNIssue 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

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