Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2004, 9338-9355 [05-3551]

Download as PDF 9338 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 42229). The notice solicited proposals from for-profit entities to demonstrate that they could successfully provide comprehensive coordinated care for the frail elderly under a prepaid fullycapitated payment system. On November 26, 2004, we published a notice in the Federal Register (69 FR 68931) withdrawing the August 10, 2001 solicitation. To date, we have received one application, and we do not want to foreclose the application process for other interested parties. Therefore, we are canceling the previously published notice of withdrawal. This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. Authority: Section 1894(h) and 1934(h) of the Social Security Act (42 U.S.C. 1395). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare-Supplementary Medical Insurance Program) Dated: February 17, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05–3553 Filed 2–24–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9025–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2004 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2004 through December 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 VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.) Questions concerning items in Addendum III may be addressed to 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. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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 3month 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 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 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— —Date published; —Federal Register citation; —Parts of the Code of Federal Regulations (CFR) that have changed (if applicable); —Agency file code number; and —Title of the regulation. • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. • Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number. • Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR. III. How To Obtain Listed Material A. Manuals Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250–7954, Telephone (202) 512–1800, Fax number (202) 512–2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487–4630. In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: https://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 https://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). PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 9339 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 https://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 https://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 E:\FR\FM\25FEN1.SGM 25FEN1 9340 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 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 NCD publication titled ‘‘Treatment of Obesity,’’ use CMSPub. 100–03, Transmittal No. 23. (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: February 14, 2005. 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. 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); and December 30, 2004 (69 FR 78428). Addendum II—Description of Manuals, Memoranda, and CMS Rulings An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468. ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS [October Through December 2004] Transmittal No. Manual/Subject/Publication Number Medicare General Information (CMS-Pub. 100–01) 11 ...................... 12 ...................... 13 ...................... 14 ...................... Manual Revision Regarding Waiver of Annual Deductible and Coinsurance for Both Ambulatory Surgery Center Facility, and Ambulatory Surgery Center/Hospital Outpatient Department Physician Services Exceptions to Annual Deductible and Coinsurance. New Policy and Refinements on Billing Non-covered Charges to Fiscal Intermediaries. Applications of Deductible and Coinsurance in Liability and Indemnification Situations. Medicare Termination of Beneficiaries With End-Stage Renal Disease. Scheduled Release for January Updates to Software Programs and Coding/Files. Medicare Benefit Policy (CMS-Pub. 100–02) 23 ...................... 24 ...................... 25 ...................... 26 ...................... 27 ...................... 28 ...................... Revised Requirements for Chiropractic Billing of Active/Corrective Treatment And Maintenance Therapy Full Replacement of CR 3063 Chiropractor’s Services. Necessity of Treatment. Treatment Parameters. Revision of § 300.5.1, Chapter 15 of the Medicare Benefit Policy Manual to Include 22x Type of Bill for Diabetes Self-Management Training. Special Claims Processing Instructions for Fiscal Intermediary. Implementation of Coverage of Religious Nonmedical Health Care. Institution Items and Services Furnished in the Home, Medicare Modernization Act Section 706. Coverage of Religious Nonmedical Health Care Institution Items and Services Furnished in the Home. Coverage and Payment of Durable Medical Equipment aUnder the Religious Nonmedical Health Care Institution Home Benefit. Coverage and Payment of Home Visits Under the Religious Nonmedical Health Care Institution Home Benefit. Inclusion of Forteo as a Covered Osteoporosis Drug and Clarification of Manual. Instructions Regarding Osteoporosis Drugs. Medical Supplies (Except for Drugs and Biologicals Other Than Covered Osteoporosis Drugs) and the Use of Durable Medical Equipment. Covered Osteoporosis Drugs. New End-Stage Renal Disease Composite Payment Rates Effective January 1, 2005. Hospice Pre-Election Evaluation and Counseling Services. Documentation. Payment. Medicare National Coverage Determinations (CMS-Pub. 100–03) 22 23 24 25 26 ...................... ...................... ...................... ...................... ...................... This Transmittal has been rescinded and replaced with Transmittal 25. Treatment of Obesity. Dementia and Neurodegenerative Diseases. Percutaneous Transluminal Angioplasty. Electrocardiographic Services. Medicare Claims Processing (CMS-Pub. 100–04) 305 .................... 306 .................... 307 .................... VerDate jul<14>2003 Disabling the Common Working File 57x3 Consistency Error Code. Full Replacement of CR 3415, 3rd Update to the 2004 Medicare Physician Fee Database. This Transmittal has been rescinded and replaced with Transmittal 314. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9341 ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 308 .................... Two New Medicare Summary Notice (MSN) Messages for Parenteral Pumps-DMERC Only. Durable Medical Equipment. Fiscal Year 2005 Inpatient Prospective Payment System, Long Term Care. Hospital and Other Bill Processing Changes Related to the Inpatient. Prospective Payment System Final Rule. Billing Requirements for Positron Emission Tomography Scans for Dementia and Neurodegenerative Diseases. Billing Instructions. Positron Emission Tomography Scan Qualifying Conditions and Healthcare. Common Procedure Coding System Code Chart. Coverage for Positron Emission Tomography Scans for Dementia and Neurodegenerative Disease. Instructions for Completion of Form CMS–1450. Health Insurance Portability and Accountability Act Health Care and Coordination of Benefits. Coordination of Benefits. General Instructions for Completion of Form CMS—1450 for Billing. Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. Remittance Advice Remark Code and Claim Adjustment Reason Code Update. Percutaneous Transluminal Angioplasty. Temporary Change in Carrier Jurisdictional Pricing Rules for Purchased Diagnostic Services. Clarification of Messages in Chapter 1, Section 10.1.1.1 to Match Official Listing on the WPC-Electronic Data Interchange Web Site. Claims Processing Instructions for Payment Jurisdiction for Claims Received on or After April 1, 2004. Clarification to Chapter 26 of the Internet Only Manual. Patient and Insured Information. Provider of Service or Supplier Information. Clarification of CR 3176—Payment Amounts for End-Stage Renal Disease Drug. Administration Supplies: Healthcare Common Procedure Coding System A4657 and A4913. Comprehensive Outpatient Rehabilitation Facility/Outpatient Physical Therapy. Edit for Billing Inappropriate Supplies. Reminder Notice of the Implementation of the Ambulance Transition. Schedule. Instructions for Downloading the Medicare Zip Code File. Release Medlearn Article for Change Request CR 2813 End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Test(s). Update Regarding the Use of American Dental Association’s (ADA) Current Dental Terminology Codes on Medicare Contractor’s Web Sites and Other Electronic Media. Displaying Material With Content Development Team Codes. Use of Content Development Team Nomenclature and Descriptors. American Dental Association Copyright Notice. Point and Click License, and Shrink Wrap License. Samples of Content Development Team Nomenclature and Descriptors. Quarterly Update to Correct Coding Initiative (CCI) edits, Version 11.0, Effective January 1, 2005. New Waived Tests—January 1, 2005. Invalid Diagnosis Code Editing—Second Phase. This Transmittal has been rescinded and replaced with Transmittal 374. 2005 Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers. Durable Medical Equipment Regional Carrier Only—Payment to Providers/Suppliers Qualified To Bill Medicare for Prosthetics and Certain Custom-Fabricated Orthotics. Provider Billing for Prosthetics and Orthotic Services. Durable Medical Equipment Carrier—Beneficiary Submitted Claims, Process First Claim. General Billing for DME, Prosthetics, Orthotic Devices, and Supplies. Durable Medical Equipment Carrier—Beneficiary Submitted Claims, Process First Claim. New Policy and Refinements on Billing Noncovered Charges to Fiscal Intermediaries. Provider Billing of Noncovered Charges to Fiscal Intermediaries. General Information on Institutional Noncovered Charges Prior to Billing. Provider-Liable Fully Noncovered Outpatient Claims. Summary of All Types of Institutional No Payment Claims. General Operational Information on Institutional Noncovered Charges. Noncovered Charges on Institutional Demand Bills. Traditional Demand Bills. Summary of Methods for Institutional Demand Billing. Line-Item Modifiers Related to Reporting of Noncovered Charges When Covered and Noncovered Services Are on the Same Institutional Claim. Clarifying Institutional Instructions for Outpatient Therapies Billed As Noncovered, on Other Than Hold Harmless Prospective Payment System Claims, and for Critical Access Hospitals Billing the Same Health Common. Procedure Coding System Requiring Specific Time Increments. Instructions for Noncovered Charges on Institutional Ambulance Claims. Clarification on Notice Requirements Related to Billing Noncovered Charges for ‘‘Bundled’’ Institutional Benefits: Laboratory and Rural Health Clinic/Federally Qualified Health Clinic. Issued to a specific audience, not posted to the Internet/Intranet due to the confidentiality of instruction. Payment of Beneficiary Submitted Flu Claims and Flu Claims Submitted by Non-Enrolled Providers. This Transmittal has been rescinded and replaced with Transmittal 400. 309 .................... 310 .................... 311 .................... 312 313 314 315 316 .................... .................... .................... .................... .................... 317 .................... 318 .................... 319 .................... 320 .................... 321 .................... 322 .................... 323 .................... 324 325 326 327 328 329 .................... .................... .................... .................... .................... .................... 330 .................... 331 .................... 332 .................... 333 .................... 334 .................... 335 .................... VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9342 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 336 .................... Indian Health Service or Tribal Hospitals including Critical Access Hospital. Payment Methodology for Inpatient Social Admissions and Outpatient Services Occurring During Concurrent Stays. Indian Health Service/Tribal Hospital Inpatient Social Admits. Change in Hospital Type of Bill for Billing Diagnostic and Screening Mammographies. Mammography Services. Computer-Aided Detection Add-On Codes. Billing Requirements—Fiscal Intermediary Claims. Rural Health Clinic/Federally Qualified Health Center Claims With Dates of Service Prior to January 1, 2002. Rural Health Clinic/Federally Qualified Health Center Claims With Dates of Service on or After January 1, 2002. Fiscal Intermediary Requirements for Nondigital Screening Mammographies. Mammograms Performed With New Technologies. Removal of the Skilled Nursing Facility No Pay File. Issued to a specific audience, not posted to the Internet/Intranet due to the Sensitivity of Instruction. Annual Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement. Implementation of the Medicare Physician Fee Schedule (MPFS) National Abstract File for Purchased Diagnostic Tests and Interpretations. Payment Jurisdiction Among Local Carriers for Services Paid Under the Physician Fee Schedule and Anesthesia Services. Payment Jurisdiction for Purchased Services. Payment to Physician or Other Supplier for Purchased Diagnostic Tests—Claims Submitted to Carriers. Payment to Supplier of Diagnostic Tests for Purchased Interpretations. Abstract File for Purchased Diagnostic Tests/Interpretations. Change to the Common Working File Skilled Nursing Facility Consolidated. Edits for Ambulance Transports to or From a Diagnostic or Therapeutic Site Ambulance Services. Skilled Nursing Facility Billing. Clarification: Modifiers for Transportation of Portable X-rays. Transportation Component. Update of Healthcare Common Procedure Coding System Codes and File Names, Descriptions and Instructions for Retrieving the 2005 Ambulatory Surgery. Center Healthcare Common Procedure Coding System Deletions and Master Listing. This Transmittal is rescinded and replaced with Transmittal 353. This Transmittal is rescinded and replaced with Transmittal 352. Inpatient Rehabilitation Facility Classification Requirements. Medicare Inpatient Rehabilitation Facility Classification Requirements. Criteria That Must Be Met By Inpatient Rehabilitation Hospitals. Verification Process To Be Used To Determine if the Inpatient Rehabilitation. Facility Met the Classification Criteria. Verification of Compliance Using International Classification of Disease 9th Edition Clinical Modification and Impairment Group Codes. January 2005 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective January 1, 2005. This Transmittal is rescinded and replaced with Transmittal 359. Editing for Part B Carriers and Durable Medical Equipment Regional Carriers for Duplicate Claims in Process at the Same Time. Editing of Hospitals and Skilled Nursing Facilities Part B Inpatient Services. Three Places After the Decimal Point for Application Service Provider Drug File. Durable Medical Equipment Regional Carrier—Revision to CR 2631. Requirements for Durable Medical Equipment Regional Carrier Claims. Claims Processing Instructions for Payment Jurisdiction for Claims Received on or After April 1, 2004—Durable Medical Equipment Regional Carrier Only. DMERC—Beneficiary Submitted Claims, Process First Claim. This Transmittal has been rescinded and replaced with Transmittal 375. This Transmittal has been rescinded and replaced with Transmittal 376. Implementation of Coverage of Religious Nonmedical Health Care Institution. Items and Services Furnished in the Home, MMA section 706. Noncovered Charges on Outpatient Bills. Billing and Payment of Religious Nonmedical Health Care Institution Items and Services Furnished in the Home. Inclusion of Forteo As a Covered Osteoporosis Drug and Clarification of Manual Instructions Regarding Osteoporosis Drugs. Osteoporosis Injections as Home Health Agency Benefit. This Transmittal replaces Transmittal 349. Annual Update of Healthcare Common Procedure Coding System Codes for Skilled Nursing Facility Consolidated Billing. Medicare Modernization Act Drug Pricing Update—Payment Limit for J0207.(Amifostine). Update to the Prospective Payment System for Home Health Agencies for Calendar Year 2005. Annual Updates to the Home Health Pricer. 2005 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. Common Working File Editing for the Initial Preventive Physical Examination. Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction. Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction. This Transmittal has been rescinded and replaced with Transmittal 425. Instructions for Completion of Form CMS–1450. Fee Schedule Update for 2005 for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies. New Case-Mix Adjusted End-Stage Renal Disease (ESRD) Composite. 337 .................... 338 .................... 339 .................... 340 .................... 341 .................... 342 .................... 343 .................... 344 .................... 345 .................... 346 .................... 347 .................... 348 .................... 349 .................... 350 .................... 351 .................... 352 .................... 353 .................... 354 355 356 357 .................... .................... .................... .................... 358 359 360 361 .................... .................... .................... .................... 362 363 364 365 366 367 368 369 .................... .................... .................... .................... .................... .................... .................... .................... VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9343 ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. 370 .................... 371 .................... 372 .................... 373 .................... 374 .................... 375 .................... 376 .................... 377 .................... 378 .................... 379 .................... 380 .................... VerDate jul<14>2003 Manual/Subject/Publication Number Payment Rates and New Composite Rate Exceptions Window for Pediatric. ESRD Facilities. Outpatient Provider Specific File. Calculation of Case Mix Adjusted Composite Rate. Required Information for In-Facility Claims Paid Under the Composite Rate. Updated Billing Instructions for Rural Health Clinics and Federally Qualified. Health Centers. General Billing Requirements. Special Federally Qualified Health Centers Requirements. Reporting of Preventive Services in the Federally Qualified Health Centers. Benefit by Independent Federally Qualified Health Centers. Reporting of Specific Healthcare Common Procedure Coding System Codes for Hospital-based Federally Qualified Health Centers. General Billing Requirements for Preventive Services. Bills Submitted to Fiscal Intermediary. Special Instructions for Independent and Provider-Based Rural Health Clinics/Federally Qualified Health Centers. Claims Submitted to Intermediaries for Mass Immunizations of Influenza and Pneumococcal Pneumonia Vaccine Payment for Computer Add-on Diagnostic and Screening Mammograms for Fiscal Intermediary and Carriers. Rural Health Centers/Federally Qualified Health Centers Claims With Dates of Service Prior to January 1, 2002. Rural Health Centers/Federally Qualified Health Centers Claims With Dates of Service on or After January 1, 2002. Healthcare Common Procedure Coding Codes for Billing. Additional Coding Applicable to Claims Submitted to Fiscal Intermediary. Special Billing Instructions for Rural Health Centers and Federally Qualified. Health Centers. Electrical Stimulation. Electromagnetic Therapy. Payment for Referred Laboratory Automated Multi-Channel Chemistry Tests. Claims Processing Requirements for Panel and Profile Tests. History Display. New End-Stage Renal Disease Composite Payment Rates Effective Lanuary 1, 2005. Publication of Composite Rates. Determining Individual Facility Composite Rate. Required Information for In-Facility Claims Paid Under the Composite Rate. Epoetin Alfa. Epoetin Alfa Facility Billing Requirement Using UB–92/Form CMS–1450. Payment Amount for Epoetin Alfa. Epoetin Alfa Provided in the Hospital Outpatient Departments. Darbepoetin Alfa for End-Stage Renal Disease Patients. Clarification to IOM Chapter 17, Section 80.4 Regarding Claims for Blood Clotting Factors. Billing for Blood Clotting Factors. This Transmittal has been rescinded and replaced with 388. This Transmittal has been rescinded and replaced with 389. Hospital Outpatient Prospective Payment System: Misclassified Drugs and Biologicals, Ganciclovir Long Act Implant, Beg Live Intravesical Vac, and Gallium ga 67; Adjustments Due to Misclassification. Full Replacement of CR 3308, 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. Provider Liability Instructions. Low Osmolar Contrast Material/Laboratory Tests/Payment for Inpatient Servces. Furnished by a Critical Access Hospital. Payment for Inpatient Services Furnished by a Critical Access Hospital. Standard Method—Cost Based Facility Services, With Billing of Carrier for Professional Services. Clinical Diagnostic Laboratory Tests Furnished by Critical Access Hospitals. Changes to the Laboratory National Coverage Determination Edit Software for January 2005. Revisions and Corrections to Chapter 29 of the IOM, Claims Processing Manual—Appeals. CMS Decisions Subject to the Administrative Appeals Process. Who May Appeal. Provider or Supplier Appeals When the Beneficiary Is Deceased. Where To Appeal and Initial Determinations. Social Security Office. Part A Fiscal Intermediary. Providers Right To Appeal Certain Initial Determinations. Part B Carrier (or Fiscal Intermediary Acting As a Carrier). Quality Improvement Organization. Time Limits for Filing Appeals. Amount in Controversy Requirements. Limitation on Liability. Part A Appeals Procedures. Finding Good Cause for Late Filing of Part A Redetermination. General. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9344 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number Establishment of Time Limits for Filing. Conditions Which Establish Good Cause. Procedures To Establish Good Cause. Examples of Situations Where Good Cause Exists. Where Good Cause Is Not Found. Redetermination of a Part A Payment Determination. Place and Manner of Filing Requests for Redeterminations and What Constitutes a Request for Redetermination. Evaluating the Evidence and Making the Redetermination. Preparing the Determination. Completing the Determination. Notice of Further Appeal Rights. Preventing Duplicate Payment in Reversal Cases. Effectuating Favorable Final Appellate Decisions That a Beneficiary Is ‘‘Confined To Home’’—Regional Home Health Intermediaries Only. Model Medicare Redetermination Notice. Request for Hearing Under Part A. Right to Representation Under Part A. Reconsiderations, Hearings, and Appeals Where a Quality Improvement. Organization Has Review Responsibility. Reconsiderations. Hearings. Appeals of Institutional Supplementary Medical Insurance (Part B) Claim Decisions. Appeals by Hospitals of Diagnosis Related Group Assignments Under Prospective Payment System—Review of Initial Diagnosis Related Group Assignments. Part B Appeals Procedures for Fiscal Intermediaries and Administrative Law Judge Instructions for Fiscal Intermediaries Redetermination and Hearing Officer (HO) Hearing Supplemental Medical Insurance. Redetermination. What Constitutes a Request for Redetermination & Handling Beneficiary Inquiries. Elements of a Redetermination. Requests for Hearing. Preparation for the Hearing. In-Person and Telephone Hearing Procedures. Request for Hearing Before an Administrative Law Judge. Scope and Effect of Office of Hearings & Appeals, Social Security. Administration Administrative Law Judge Decisions Under Part A. Determining the Amount in Controversy for Administrative Law Judge Hearing. Requests Filed With Social Security Administration. Requests Filed With the Fiscal Intermediary. Action on Incoming Requests for Administrative Law Judge Hearing. Requests for Claim File (Sent by Hearing Office). Examination of Claim File. Prehearing Case Redetermination. Routing the Administrative Law Judge Hearing Claim File. Effectuating Decisions. Effectuating Favorable Final Appellate Decisions That a Beneficiary Is ‘‘Confined To Home’’—Regional Home Health Intermediaries Only.Effectuation of Reversal of Decision Where There Was Subsequent Utilization of Benefits in the Same Benefit Period. Effect of Court Decisions. Standard Exhibits Referred to in Sections 40.5–50.7. Part B Appeals Procedures—Carriers. Initial Determinations. Steps in the Appeals Process: Overview. Fiscal Intermediary and Carrier Correspondence With Beneficiaries or Other Parties Regarding Appeals. Appointment of Representative—Introduction. Who May Be a Representative. How To Make and Revoke an Appointment. Rights and Responsibilities of a Representative. Timeliness of an Appeal Request and Completeness of Appointment. Incapacitation of Death of Beneficiary. Disclosure of Individually Identifiable Beneficiary Information to Amount in Controversy—General Requirements. Additional Considerations for Calculation of the Amount in Controversy. Aggregation of Claims to Meet the Amount in Controversy. General Procedure To Establish Good Cause. Good Cause Not Found for Beneficiary, or for Provider, Physician, or Other Supplier. General Guidelines. Letter Format. How To Establish Reading Level. Required Elements in Appeals Correspondence. Disclosure of Information to Third Parties. Fraud and Abuse Investigations. Medical Consultants Used. VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9345 ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. 382 .................... 383 .................... 384 .................... 385 .................... 386 .................... 387 .................... 388 .................... VerDate jul<14>2003 Manual/Subject/Publication Number Multiple Beneficiaries. Redetermination—The First Level of Appeal. Filing a Request for Redetermination. Time Limit for Filing a Request for Redetermination. The Redetermination. The Redetermination Determination. Redetermination Determination. Informing the Beneficiary and Provider Communities About the Telephone. Redetermination Process. Redetermination Determination Letters. Hearing Officer Hearing—The Second Level of Appeal. Time Limit for Filing a Request for a Hearing Officer Hearing. Request for a Hearing Officer Hearing Filed Prior to a Redetermination. Timely Processing Requirements. Contractor Responsibilities—General. Requests for Transfer of In-Person Hearing. Acknowledgment of Request for a Hearing Officer Hearing. Case File Development. In-Person Hearing. Telephone Hearing. Qualifications and General Responsibilities. Preparation for the Hearing Officer Hearing. Scheduling the Date, Time and Place of Hearing. Pre-Hearing Review of the Evidence. Forwarding Copy of Case File Prior to Telephone Hearing. The Hearing Officer Hearing Decision Timeliness. Delaying Effectuation. Hearing Officer Reply to Reopening Request. Requests for Part B Administrative Law Judge Hearing. Forwarding Request to Social Security Administration/Office of Hearings & Appeals. Case File Preparation. Effectuation Time Limits. Requests for Case Files. Part A and Part B Quality Improvement and Data Analysis Activities. Workload Data Analysis Program. Quality Improvement Activities. Submitting Summary Reports to CMS. Managing Appeals Workloads. Standard Operating Procedures. Execution of Workload Prioritization. Workload Priorities. Reopening and Revision of Claim Determinations and Decisions. Development of Appeals. How Issues May Arise. Summary of Conditional Under Which a Determination or Decision May Be Reopened. Determining Date of Initial or Appeal Determination or Decision. Who May Reopen an Initial Appeal Determination or Decision. Actions to Permit Reopening Within the 1 Year or 4 Year Period. Good Cause for Reopening. Definitions. Unrestricted Reopening. Reopening an Initial Determination. Reopening a Redetermination or Redetermination Determination. Reopening a Hearing Officer Hearing Decision. Notice of Results of Reopening. Exception to Sending Notice of Revision to Parties—Cases Involving Limitation of Recovery for Beneficiary. Refusal to Reopen Is Not an ‘‘Initial Determination’’. Revised Determination or Decision. Independent Laboratory Billing for the Technical Component (TC) of Physician Pathology Services to Hospital Patients. Payment for Pathology Services. This revision rescinded Transmittal. Inpatient Psychiatric Facility Prospective Payment System. January 2005 Update of the Hospital Outpatient Prospective Payment System. Summary of Outpatient Prospective Payment System Outpatient Code Editor. Data Changes and Outpatient Prospective Payment System Pricer Logic. Changes; Changes to Payment for Diagnostic Mammography. Hospice Pre-election Evaluation and Counseling Services. This instruction is to inform the fiscal intermediaries that the January 2005. Outpatient Prospective Payment System Outpatient Code Editor Specifications have been updated with new additions, changes, and deletions. Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9346 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 389 .................... 390 .................... Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increase—Skilled Nursing Facility Consolidated.Billing As It Applies to Rural Health Clinics and Federally Qualified Health.Center Services. Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2003 for Inpatient Rehabilitation Facility Prospective Payment System. LIP Adjustment: The Supplemental Security Income Medicare Beneficiary Data for Inpatient Rehabilitation Facility Paid Under Prospective Payment System. ZThis revision is rescinded and replaced with revision 401. This revision is rescinded and replaced with revision 396. Ambulance Fee Schedule—Medical Conditions List. New Dispensing/Supply Fee Codes for Oral Anti-Cancer, Oral Anti-Emetic, Immunosuppressive, and Inhalation Drugs. Pharmacy Supply Fee. 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 Carriers Drugs. Calculation of the Average Wholesale Price. Detailed Procedures for Determining Average Wholesale Prices and the Drug.Payment Allowable 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. Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. Expansion of the Existing Interrupted Stay Policy Under Long Term Care. Hospital Prospective Payment System. Incorrect Reporting of Miles Time Units Services Indicator When Drugs are Billed Using a National Drug Code. Miles/Times/Units/Services. Methodology of Coding Number of Services, Miles Times Units Services. Count and Miles Times Units Services Indicator Fields. 2005 Part B Deductible Update to the Back Page of Medicare Summary Notices. Back of the Medicare Summary Notices—Carriers and Intermediaries. January Update to the Medicare Outpatient Code Editor Version 20.1 for Bills from Hospitals That Are Not Paid Under the Outpatient Prospective Payment System. January 2005 Update of the Hospital Outpatient Prospective Payment System: Billing Devices That Do Not Have Transitional Pass-Through Status, and That Are Not Classified As New Technology Ambulatory Payment Classification Groups. Requirements That Hospitals Report Device Codes on Claims on Which They Report Specified Procedures. Edits for Claims On Which Specified Procedures Are To Be Reported With Device. Codes. January 2005 Update of the Hospital Outpatient Prospective Payment System: Changes to Coding and Payment for Drug Administration. Billing and Payment for Drugs and Biologicals. Coding and Payment for Drug Administration. Emergency Change to Carrier Instructions for the End-Stage Renal Disease. 50/50 Rule Implementation. Update to Health Care Claims Status Category Codes and Health Care Claim Status Codes for Use With the Health Care Claim Status Request and Response ASC X12N 276/277. Hospital Billing for Repetitive Services. Inpatient Billing From Hospitals and Skilled Nursing Facilities. Frequency of Billing for Outpatient Services to Fiscal Intermediaries. Hospital and Community Mental Health Center Reporting Requirements for Services Performed on the Same Day. Cardiovascular Disease Screening. Healthcare Common Procedure Coding System Coding for Cardiovascular Screening. Carrier Billing Requirements. Fiscal Intermediary Billing Requirements. Diagnosis Code Reporting. Medicare Summary Notices. Remittance Advice Remark Codes. Claims Adjustment Reason Codes. Diabetes Screening Tests. Medicare Health Insurance Portability & Accountability Act Electronic Claims. Compliance Report—Reporting Timeframe Extension. Ambulance Inflation Factor. 391 .................... 392 .................... 393 394 395 396 .................... .................... .................... .................... 397 .................... 398 .................... 399 .................... 400 .................... 401 .................... 402 .................... 403 .................... 404 .................... 405 .................... 406 .................... 407 .................... 408 .................... 409 .................... 410 .................... 411 .................... VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9347 ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 412 .................... Skilled Nursing Facility Consolidated Billing Services Furnished Under an ‘‘Arrangement’’ With an Outside Entity. ‘‘Under Arrangements’’ Relationships. Skilled Nursing Facility and Supplier Responsibilities. Medicare Part A Skilled Nursing Facility Prospective Payment System Pricer. Update Fiscal Year 2005 for 9 Metropolitan Statistical Areas With New Wage.Index Values Effective January 1, 2005. Skilled Nursing Facility Prospective Payment System Pricer Software. Emergency Update to the 2005 Medicare Physician Fee Schedule Database. Temporary Change in Carrier Jurisdictional Pricing Rules for Purchased Diagnostic Services. Interest Payment on Clean Claims Not Paid Timely. This revision rescinded and replaced revision 294. Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction. This Transmittal has been rescinded and replaced with Transmittal 423. Good Cause Waiver of Late Claim Filing Payment Reduction Penalty and Monitoring of Late Claims Submissions. Extend Time for Good Cause. Conditions Which Establish Good Cause. Procedure To Establish Good Cause. Good Cause Is Not Found. Preparing Common Working File (CWF) Claim Records for Services Subject to 10 Percent Payment Reduction. Monitoring Late Claims Submission Violations. Sample Notification Letter. Violations That Are Not Developed for Referral. Correction to January 2005 Annual Update of Healthcare Common Procedure Coding. System Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement. Update to Fiscal Year 2005 Wage Index for Inpatient Prospective Payment and Outpatient Prospective Payment System Hospitals . 413 .................... 414 415 416 417 418 419 420 .................... .................... .................... .................... .................... .................... .................... 421 .................... 422 .................... Medicare Secondary Payer (CMS-Pub. 100–05) 20 ...................... 21 ...................... 22 ...................... Secondary Payer (Medicare Secondary Payer) Savings Report Redesign. Monthly Intermediary Report (Form CMS–1563) and Monthly Carrier Report. (Form CMS–1564) on Medicare Secondary Payer Savings. Savings Calculations. Source of Savings. Type of Savings. Pre-payment Savings—Cost Avoid (Unpaid Medicare Secondary Payer Claims). Pre-payment Savings—Full Recoveries. Pre-payment Savings—Partial Recoveries. Post-payment Savings—Full Recoveries. Post-payment Savings—Partial Recoveries. Total Post-payment Savings. Electronic Submission. Data Entry of the Forms CMS–1563 and CMS–1564. System Calculations for Forms CMS–1563 and CMS–1564. Instructions on Processing Certain Types of Medicare Secondary Payer.Claims and to Balance the Outbound Remittance Advice. Instructions to Physicians and Suppliers on How To Submit Claims to a Medicare Carrier When There Are One or More Primary Payers. Medicare Secondary Payer Debt Referral Instructions and Debt Collection Improvement Act of 1996 Activities. Courtesy Copy of All Medicare Secondary Payer Group Health Plan-Based. Recovery Demand Packages to the Employer’s Insurer/Third Party Administrator. Insurer/Third Party Administrator Courtesy Copy Letter. Medicare Secondary Payer Debt Referral, ‘‘Write-Off—Closed’’ Instructions and Debt Collection Improvement Act of 1996 Activities. Background. Debt Selection, Verification of Debt, and Updating of Interest. ‘‘Intent to Refer’’ Letter and Inquiries/Replies Related to Debt Improvement Act of 1996 Activities Debt Collection System, Debt Collection System Input, Debt Transmission, Documentation to Treasury. Actions Subsequent to Debt Collection System Input. Medicare Secondary Payer Debt Collection Improvement Act of 1996 Tracking Report for Referral/Collection. Monitoring Debts Excluded From the Debt Collection Improvement Act of 1996. Referral Process. Financial Reporting. Compromise Requests and Extended Repayment Agreement Requests, and Waiver of Interest Requests. Miscellaneous Questions and Answers. Medicare Financial Management (CMS-Pub. 100–06) 55 ...................... 56 ...................... VerDate jul<14>2003 Reporting Appeals Redetermination Information on Forms CMS–2591 and 2590. Revision to Balancing Requirement on Form 5, Line 10, of the Contractor. Reporting of Operational and Workload Data. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9348 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 57 ...................... Revised Reporting Requirements for Contractor Reporting of Operational Workload Data Health Professional Shortage Area Quarterly Report. Issued to specific audience, not posted to Internet/Intranet due to sensitivity of instruction. Notice of New Interest Rate for Medicare Overpayments and Underpayments. Revised Instructions on Contractor Procedures for Provider Audit and the Provider Statistical & Reimbursement Report. Submission of Cost Report Data to CMS. Desk Review Exceptions Resolution Process. Definition of Field Audits. Purpose of Field Audits. Establishing the Objective/Scope of the Field Audit. Audit Confirmation Letter. Entrance Conference. Tests of Internal Control. Designing Tests/Sampling. Pre-Exit Conference. Finalization of Audit Adjustments. Exit Conference. Medicare Cost Report and All Related Documents. Qualifications. Internal Quality Control. Final Settlement of the Cost Report. Audit Responsibility When Provider Changes Contractors. Audits of Home Offices. Standards for Issuance of an Audit Report for a Home Office. Provider Permanent File. Contractor Responsibility in Suspected Fraud or Abuse Cases. New Location Code Interstate Commerce Commission, Status Code AR and Modified Intent Letter for Unfiled Cost Reports Only. Recovery of Overpayment Due to Overdue Cost Report. Provider Overpayment Recovery System User Manual. List of Status Codes. Content of Demand Letters—Fiscal Intermediary Serviced Providers. 58 ...................... 59 ...................... 60 ...................... 61 ...................... Medicare State Operations Manual (CMS-Pub. 100–07) 3 ........................ 4 ........................ Medicare Systems Acceptance of New Provider Numbers for Federally Qualified Health Centers. Guidance to Surveyors for Long Term Care Facilities. 5 ........................ Revisions to Appendix P (Survey Protocols for Long Term Care Facilities) and Appendix PP (Guidance to Surveyors for Long Term Care Facilities). Medicare Program Integrity (CMS-Pub. 100–08) 84 85 86 87 ...................... ...................... ...................... ...................... 88 ...................... 89 ...................... VerDate jul<14>2003 This revision is rescinded and replaced by revision 86. This revision is rescinded and replaced by revision 87. Payment for Emergency Medical Treatment and Labor Act—Mandated Screening and Stabilization Services. Informing Beneficiaries About Which Local Medical Review Policy and/or Local Coverage Determination and/or National Coverage Determination Is Associated With Their Claim Denial. Timeframes for Processing 855 Enrollment Applications. Provider Enrollment, Chain and Ownership System. Updating Financial Reporting Requirements for Medical Review and Local Provider Education and Training. Medical Review and Local Provider, Education, and Training. Medical Review Overview. Reporting Medical Review Workload and Cost Information and Documentation in Contractor Administrative, Budget & Financial Management II. Contractor Administrative, Budget & Financial Management II Reporting for Medical Review Activities. Automated Review Workload and Cost (Activity Code 21001). Routine Review Workload and Cost (Activity Code 21002). Data Analysis Cost (Activity Code 21007). Third Party Liability or Demand Bills Workload and Cost (Activity Code 21010). Policy Reconsideration/Revision Activities (Activity Code 21206). Medical Review Program Management Costs (Activity Code 21207). New Policy Development Activities (Activity Code 21208). Complex Probe Review Workload and Cost (Activity Code 21220). Prepay Complex Review Workload and Cost (Activity Code 21221). Post-pay Complex Review Workload and Cost (Activity Code 21222). Medicare Integrity Program Comprehensive Error Rate Testing Support. Medicare Integrity Program Comprehensive Error Rate Testing Support.(Activity Code 21901). Reporting Internal Staff Training. Reporting Medical Review Savings in Contractor Reporting of Operational & Workload Data. Local Provider Education and Training Overview. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9349 ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. 90 ...................... 91 ...................... 92 ...................... Manual/Subject/Publication Number Reporting Local Provider Education and Training Workload and Cost Information and Documentation in Contactor Administrative, Budget & Financial Management II. One-on-One Provider Education a Workload and Cost (Activity Code 24116). Education Delivered to Group of Providers Workload and Cost (Activity Code 24117). Education Delivered via Electronic or Paper Media Workload and Cost (Activity Code 24118). Prepayment Review of Claims for Medical Review Purposes. Revision of Program Integrity Manual, Section 3.11.1.4. Requesting Additional Documentation. Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of instruction. Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100–09) 00 ...................... None. Medicare Managed Care (CMS-Pub. 100–16) 63 ...................... 64 ...................... Home Health Services Appeals. Surveys, Contracting Strategy, Grievances and Appeals. Medicare Business Partners Systems Security (CMS-Pub. 100–17) 05 ...................... Consortium Contractor Management Officer and CMS Project Officer. The (Principal) Systems Security Officer. Personnel Security/Suitability. IT Systems Security Program Management. System Security Plan. Risk Assessment. Information Technology Systems Contingency Plan. Annual Compliance Audit. Corrective Action Management Process and Plans of Action and Milestones. Computer Security Incident Response. Systems Security Profile. Fraud Control. Patch Management. Security Management Resources. Security Configuration Management. National Institute of Standards and Technology. Information Security Levels. Level 4: High Criticality and National Security Interest. Security Room. Intrusion Detection System. Internet Security. Demonstrations (CMS-Pub. 100–19) 07 08 09 10 11 12 13 ...................... ...................... ...................... ...................... ...................... ...................... ...................... Expansion of Coverage for Chiropractic Services Demonstration. This revision is rescinded and replaced with Transmittal 9. This revision is rescinded and replaced with Transmittal 10. Issued to a specific audience, not posted to Internet/Intranet due to sensitivity of instruction. Medicare Coordinated Care Demonstration—Override of Certain Medicare Secondary Payer Edit Codes. Chemotherapy Demonstration Project. Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. One Time Notification (CMS-Pub. 100–20) 118 .................... 119 .................... 120 .................... 121 .................... 122 .................... 123 124 125 126 127 .................... .................... .................... .................... .................... 128 .................... VerDate jul<14>2003 Shared Systems Maintainer Hours for Resolution of Problem Detected As a Result of Implementation of Change Request 2525 and Change Request 2527. Shared System Maintainer Hours for Resolution of Problem Detected During Health Insurance Portability and Accountability Act Transaction Release Testing. Override of Common Working File Edit for Observation Services Exceeding 48 Hours. Modification to Fiscal Intermediary Standard System Regarding Common Working File Initiated Adjustments. Shared System and Common Working File Renovation of Override Code Process and Recognition of Four 2-byte Modifier Fields on the Part B Query Record—For Multi-Carrier System Phased Implementation Approach Only. Instructions for Pricing Treprostinil (Q4077). Common Working File Duplicate Claim Edit for Referred Clinical Diagnostic and Purchased Diagnostic Services. This revision is rescinded and replaced with revision 127. Transmittal replaced by Transmittal 27 in Pub. 100–02, Medicare Benefit Policy. Instructions Applicable to the Audit of Hospitals That Are Part of an Affiliated Group in Relation 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. Promoting Medicare’s Preventive Benefits and Services on an Annual Basis. 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9350 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [October Through December 2004] Transmittal No. Manual/Subject/Publication Number 129 .................... 130 .................... 2005 Drug Administration Coding Revisions. Development of a Coordination of Benefits Agreement Auxiliary File and Modification of the Health Insurance Portability and Accountability Act 837 Coordination of Benefits Flat File and National Council for Prescription Drug Program File. Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemption Category A Devices. Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of instruction. Shared System Maintainer Hours for Resolution of Problems Detected as a Result of Implementation of Change Request 2525 and Change Request 2527 131 .................... 132 .................... 133 .................... ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER [October Through December 2004] Publication date FR vol. 69 page number CFR parts affected File code Title of regulation Medicare Program; Care Management for HighCost Beneficiaries (CMHCB) Demonstration. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Corrections. Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections. Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Fiscal Year 2005; Correction. Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005. Medicare Program; Town Hall Meeting on the Medicare Provider Feedback Group (MPFG) November 16, 2004. Medicare Program; November 22, 2004, Meeting of the Practicing Physicians Advisory Council. Medicare Program; Meeting of the Advisory Panel on Medicare Education—November 30, 2004. Medicare Program; Prospective Payment System for Inpatient Psychiatric Facilities. Medicare Program; Coverage and Payment of Ambulance Services; Recalibration of Conversion Factor; Inflation Update for CY 2005. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005. Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates. Medicare Program; Expedited Determination Procedures for Provider Service Terminations. Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures. Medicare Program; Meeting of Medicare Coverage Advisory Committee—January 25, 2005. Medicare Program; Criteria and Standards For Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2005. Medicare and Medicaid Programs; Approval of Application for Deeming Authority for Ambulatory Surgical Centers by the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. Medicare and Medicaid Programs; Notice of Withdrawal of the Solicitation of Proposals for the Private, for-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE). October 6, 2004 ..... 59929 ................................................ CMS–5015–N ........ October 7, 2004 ..... 60242 403, 412, 413, 418, 460, 480, 482, 483, 485, 489. CMS–1428–CN2 .... October 7, 2004 ..... 60158 ................................................ CMS–1249–CN ...... October 7, 2004 ..... 60157 ................................................ CMS–1360–CN ...... October 22, 2004 ... 62124 484 ......................................... CMS–1265–F ......... October 22, 2004 ... 62057 ................................................ CMS–1302–N ........ October 22, 2004 ... 62056 ................................................ CMS–1484–N ........ October 22, 2004 ... 62055 ................................................ CMS–4078–N ........ November 15, 2004 66922 412 and 413 ........................... CMS–1213–F ......... November 15, 2004 66918 ................................................ CMS–1267–N ........ November 15, 2004 66236 403, 405, 410, 411, 414, 418, 424, 484, and 486. CMS–1429–FC ...... November 15, 2004 65682 419 ......................................... CMS–1427–FC ...... November 26, 2004 69252 405 and 489 ........................... CMS–4004–FC ...... November 26, 2004 69178 416 ......................................... CMS–1478–P ........ November 26, 2004 68944 ................................................ CMS–3149–N ........ November 26, 2004 68935 ................................................ CMS–1374–GNC ... November 26, 2004 68931 ................................................ CMS–2202–FN ...... November 26, 2004 68931 ................................................ CMS–5011–WN ..... VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices 9351 ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued [October Through December 2004] Publication date FR vol. 69 page number CFR parts affected File code Title of regulation Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program. Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005; Correction. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Extension for the Hospital Applications To Receive Increases in Full Time Equivalent Resident Caps for Graduate Medical Education Payment. Medicare Program; Solicitation for Proposals for the Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities. HIPAA Program; Final Regulations for Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers Under HIPPA Titles I and IV. HIPAA Program; Notice of Proposed Rulemaking for Health Coverage Portability: Tolling Certain Time Periods and Interaction With the Family and Medical Leave Act Under HIPAA Titles I and IV. HIPAA Program; Request for Information on Benefit-Specific Waiting Periods Under HIPAA Titles I and IV. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal 2005 Rates; Correcting Amendment. Medicare Program; Town Hall Meeting on the Fiscal Year 2006 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment Systems Scheduled for February 23, 2005. Medicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (Panel)—February 23, 24, and 25, 2005 and Re-chartering of APC Panel on November 8, 2004. Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections. Medicare Program; Approval of the National Committee for Quality Assurance Deeming Authority for Medicare Advantage Local Preferred Provider Organizations. Medicare Program; Timeline for Publication of Medicare Final Regulations After Proposed or Interim Final Regulations. Medicare and Medicaid Program; Quarterly Listing of Program Issuances—July 2004 Through September 2004. CLIA Program; Continued Approval of the American Association of Blood Banks for Deeming Authority. Medicare Program; Modifications to Managed Care Rules. Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates; Wage Index Tables and Corrections. November 26, 2004 68815 447 ......................................... CMS–2175–F ......... November 30, 2004 69686 484 ......................................... CMS–1265–CN2 .... November 30, 2004 69536 403, 412, 413, 418, 460, 480, 482, 483, 485, and 489. CMS–1428–N ........ December 23, 2004 76947 ................................................ CMS–5036–N ........ December 30, 2004 78720 26 CFR Parts 54 and 602, 29 CFR Part 2590, 45 CFR Parts 144 and 146. CMS–2151–F ......... December 30, 2004 78800 26 CFR Part 54, 29 CFR Part 2590, 45 CFR Part 146. CMS–2158–P ........ December 30, 2004 78825 26 CFR Part 54, 29 CFR Part 2590, 45 CFR Part 146. CMS–2150–NC ...... December 30, 2004 78526 403, 412, 413, 418, 460, 480, 482, 483, 485, and 489. CMS–1428–F2 ....... December 30, 2004 78466 ................................................ CMS–1292–N ........ December 30, 2004 78464 ................................................ CMS–1285–N ........ December 30, 2004 78445 ................................................ CMS–1249–CN2 .... December 30, 2004 78444 ................................................ CMS–4077–FN ...... December 30, 2004 78442 ................................................ CMS–9026–N ........ December 30, 2004 78428 ................................................ CMS–9042–N ........ December 30, 2004 78426 ................................................ CMS–2490–N ........ December 30, 2004 78336 422 ......................................... CMS–4041–IFC ..... December 30, 2004 78315 419 ......................................... CMS–1427–CN ...... VerDate jul<14>2003 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9352 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices Addendum V—National Coverage Determinations [October Through December 2004] A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at https:// cms.hhs.gov/coverage. NATIONAL COVERAGE DETERMINATIONS [October Through December 2004] NCDM section Title Treatment of Obesity .............................................................................. Changes to the Laboratory NCD Edit Software for January 2005 ......... Dementia and Neurodegenerative Diseases .......................................... Percutaneous Transluminal Angioplasty ................................................ Electrocardiographic Services ................................................................ 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 4th quarter, October Through December 2004. G010041 G020001 G020105 G040026 G040081 G040086 G040090 OMB Control No. 0938–0008 0938–0022 0938–0023 0938–0025 0938–0027 0938–0033 0938–0035 0938–0037 0938–0041 0938–0042 0938–0045 0938–0046 0938–0050 0938–0062 0938–0065 0938–0074 VerDate jul<14>2003 ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. TN# 40.5 N/A 220.6.13 20.7 20.15 G040115 G040117 G040133 G040135 G040136 G040157 G040163 G040164 G040165 G040169 G040170 G040171 G040173 G040174 G040175 G040177 G040178 G040179 G040180 G040181 G040182 G040183 G040185 G040187 G040188 G040189 Issue date R23NCD ............................. R38CP ................................ R24NCD ............................. R25NCD ............................. R26NCD ............................. 10/01/04 11/26/04 10/01/04 10/15/04 12/10/04 Effective date 10/01/04 01/03/05 09/15/04 10/12/04 08/26/04 G040193 G040197 G040199 G040201 G040202 G040207 G040210 G040211 G040212 G040213 G040215 G040216 G911803 Addendum VII—Approval Numbers for Collections of Information Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget: Approved CFR Sections in Title 42, Title 45, and Title 20 (NOTE: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 414.40, 424.32, 424.44 413.20, 413.24, 413.106 424.103 406.28, 407.27 486.100–486.110 405.807 407.40 413.20, 413.24 408.6, 408.22 410.40, 424.124 405.711 405.2133 413.20, 413.24, 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, 498.3–498.5 485.701–485.729 491.1–491.11 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices OMB Control No. 0938–0080 0938–0086 0938–0101 0938–0102 0938–0107 0938–0146 0938–0147 0938–0151 0938–0155 0938–0170 0938–0193 0938–0202 0938–0214 0938–0236 0938–0242 0938–0245 0938–0246 0938–0251 0938–0266 0938–0267 0938–0269 0938–0270 0938–0272 0938–0273 0938–0279 0938–0287 0938–0296 0938–0301 0938–0302 0938–0313 0938–0328 0938–0334 0938–0338 0938–0354 0938–0355 0938–0357 0938–0358 0938–0359 0938–0360 0938–0365 0938–0372 0938–0378 0938–0379 0938–0382 0938–0386 0938–0391 0938–0426 0938–0429 0938–0443 0938–0444 0938–0445 0938–0447 0938–0448 0938–0449 0938–0454 0938–0456 0938–0463 0938–0467 0938–0469 0938–0470 0938–0477 0938–0484 0938–0501 0938–0502 0938–0512 0938–0526 0938–0534 0938–0544 0938–0564 0938–0565 0938–0566 0938–0573 0938–0578 VerDate jul<14>2003 ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. 9353 Approved CFR Sections in Title 42, Title 45, and Title 20 (NOTE: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 406.7, 406.13 420.200–420.206, 455.100–455.106 430.30 413.20, 413.24 413.20, 413.24 431.800–431.865 431.800–431.865 493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461 493.1469, 493.1483, 493.1489 405.2470 493.1269–493.1285 430.10–430.20, 440.167 413.17, 413.20 411.25, 489.2, 489.20 413.20, 413.24 442.30, 488.26 407.10, 407.11 431.800–431.865 406.7 416.41, 416.47, 416.48, 416.83 410.65, 485.56, 485.58, 485.60, 485.64, 485.66 412.116, 412.632, 413.64, 413.350, 484.245 405.376 440.180, 441.300–441.305 485.701–485.729 424.5 447.31 413.170, 413.184 413.20, 413.24 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100 489.11, 489.20, 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, 485.631 491.9, 491.10 486.104, 486.106, 486.110 441.60 442.30, 488.26 409.40–409.50, 410.36, 410.170, 411.4—411.15, 421.100, 424.22, 484.18, 489.21 412.20–412.30 412.40–412.52 488.60 484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52 414.330 482.60–482.62 442.30, 488.26 442.30, 488.26 405.2100–405.2171 488.18, 488.26, 488.28 476.104, 476.105, 476.116, 476.134 447.53 473.18, 473.34, 473.36, 473.42 1004.40, 1004.50, 1004.60, 1004.70 412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78 405.2133 405.2133, 45 CFR Parts 5, 5b; 20 CFR Parts 401, 422E 440.180, 441.300–441.310 424.20 412.105 413.20, 413.24, 413.106 431.17, 431.306, 435.910, 435.920, 435.940–435.960 417.126, 422.502, 422.516 417.143, 417.800–417.840, 422.6 412.92 424.123 406.15 433.138 486.304, 486.306, 486.307 475.102, 475.103, 475.104, 475.105, 475.106 410.338, 424.5 493.1–493.2001 411.32 411.20–411.206 411.404, 411.406, 411.408 412.230, 412.256 447.534 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 9354 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices OMB Control No. 0938–0581 0938–0599 0938–0600 0938–0610 ............. ............. ............. ............. 0938–0612 0938–0618 0938–0653 0938–0657 0938–0658 0938–0667 0938–0679 0938–0685 0938–0686 0938–0688 0938–0690 0938–0691 0938–0692 0938–0701 0938–0702 0938–0703 0938–0714 0938–0717 0938–0721 0938–0723 0938–0730 0938–0732 0938–0734 0938–0739 0938–0742 0938–0749 0938–0753 0938–0754 0938–0758 0938–0760 0938–0761 0938–0763 0938–0770 0938–0778 0938–0779 0938–0781 0938–0786 0938–0787 ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. 0938–0790 0938–0792 0938–0798 0938–0802 0938–0818 0938–0829 0938–0832 0938–0833 ............. ............. ............. ............. ............. ............. ............. ............. 0938–0841 0938–0842 0938–0846 0938–0857 0938–0860 0938–0866 0938–0872 0938–0873 0938–0874 0938–0878 0938–0883 0938–0884 0938–0887 0938–0897 0938–0907 0938–0910 0938–0911 0938–0916 ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. VerDate jul<14>2003 Approved CFR Sections in Title 42, Title 45, and Title 20 (NOTE: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 493.1–493.2001 493.1–493.2001 405.371, 405.378, 413.20 417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102, 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 433.68, 433.74, 447.272 493.1771, 493.1773, 493.1777 405.2110, 405.2112 405.2110, 405.2112 482.12, 488.18, 489.20, 489.24 410.38 410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12 493.551–493.557 486.304, 486.306, 486.307, 486.310, 486.316, 486.318, 486.325 488.4–488.9, 488.201 412.106 466.78, 489.20, 489.27 422.152 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180 45 CFR 148.120, 148.124, 148.126, 148.128 411.370–411.389 424.57 410.33 421.300–421.318 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24 417.126, 417.470 45 CFR Part 5b 413.337, 413.343, 424.32, 483.20 422.300–422.312 424.57 422.000–422.700 441.151, 441.152 413.20, 413.24 Part 484 Subpart E, 484.55 484.11, 484.20, 422.1–422.10, 422.50–422.80, 422.100–422.132, 422.300–422.312, 422.400– 422.404, 422.560–422.622 410.2 422.64, 422.111 417.126, 417.470, 422.64, 422.210 411.404–411.406, 484.10 438.352, 438.360, 438.362, 438.364 406.28, 407.27, 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, 460.210 491.8, 491.11 413.24, 413.65, 419.42 419.43 410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63 422.568 Parts 489 and 491 483.350–483.376, 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 412.23, 412.604, 412.606, 412.608, 412.610, 412.61a4, 412.618, 412.626, 413.64 411.352–411.361 Part 419 Part 419 45 CFR Part 162 413.337, 483.20 422.152 45 CFR Parts 160 and 162 Part 422 Subpart F & G 45 CFR Parts 160 and 164 405.940 45 CFR 148.316, 148.318, 148.320 412.22, 412.533 412.230, 412.304, 413.65 422.620, 422.624, 422.626 426.400, 426.500 483.16, 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 19:31 Feb 24, 2005 Jkt 205001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 70, No. 37 / Friday, February 25, 2005 / Notices OMB Control No. 0938–0920 ............. 0938–0921 ............. Approved CFR Sections in Title 42, Title 45, and Title 20 (NOTE: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 438.416, 438.710, 438.722, 438.724, 438.810 414.804 [FR Doc. 05–3551 Filed 2–24–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3119–FN] RIN 0938–AM36 Medicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. AGENCY: SUMMARY: This notice finalizes the procedures proposed in the Federal Register on December 24, 2003 (68 FR 74607). It establishes the procedures for maintaining the lists of codes that were included in the national coverage determinations (NCDs) that were announced in an addendum to the final rule published in the Federal Register on November 23, 2001 (66 FR 58788). The final notice also sets forth the circumstances in which a laboratory is permitted to use the date a specimen was retrieved from storage for testing as the date of service instead of the date of collection. DATES: Effective Date: The notice is effective on March 28, 2005. FOR FURTHER INFORMATION CONTACT: Jackie Sheridan-Moore, (410) 786–4635. SUPPLEMENTARY INFORMATION: I. Background A. Current Statutory Authority and Medicare Policies Sections 1833 and 1861 of the Social Security Act (the Act) provide for payment of, among other things, clinical diagnostic laboratory services under Medicare Part B. A laboratory furnishing tests on human specimens must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100–578) enacted on October 31, 1988, as implemented by the regulations set forth at 42 CFR part 493. Part 493 applies to all laboratories seeking payment under the Medicare and Medicaid programs. VerDate jul<14>2003 9355 19:31 Feb 24, 2005 Jkt 205001 Under section 1842(a) of the Act, we contract with carriers to perform bill processing and benefit payment functions for Medicare Part B (Supplementary Medical Insurance). Under section 1816(a) of the Act, we contract with fiscal intermediaries to perform claims processing and benefit payment functions for Medicare Part A (Hospital Insurance). Fiscal intermediaries also process claims payable from the Medicare Part B trust fund that are submitted by providers that participate in Medicare Part A, like hospitals and skilled nursing facilities. We use the term ‘‘contractor(s)’’ to mean carriers and fiscal intermediaries. Medicare contractors review and adjudicate claims for services to ensure that Medicare payments are made only for services that are covered under Medicare Part A or Part B. If a contractor develops a local coverage determination (LCD) (formerly called local medical review policies (LMRP)), its LCD/LMRP applies only within the geographic area it serves as stated in the September 26, 2003 notice (68 FR 55636). Current guidance regarding the development of LCDs/LMRPs appears in section 13.1.3 of the Program Integrity Manual (HCFA Pub. 100–8). B. Legislation Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105– 133) enacted on August 5, 1997, mandates the use of a negotiated rulemaking committee to develop national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B by January 1, 1999. Section 4554(b)(2) of the BBA requires that these national coverage policies be designed to promote program integrity and national uniformity and simplify administrative requirements for clinical diagnostic laboratory services payable under Medicare Part B. As directed by this statutory provision, we convened a negotiated rulemaking committee that developed recommendations for coverage and administrative policies in accordance with the provisions of the BBA. On March 10, 2000, we published a proposed rule in the Federal Register (65 FR 13082) proposing to adopt the committee’s recommendations. The final rule was published on November PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 23, 2001 in the Federal Register (66 FR 58788). C. National Coverage Determinations (NCDs) The final rule on coverage and administrative policies for clinical diagnostic laboratory services includes an addendum containing NCDs for 23 clinical diagnostic laboratory tests. These NCDs are binding on all Medicare carriers, intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans. In accordance with the recommendations of the negotiated rulemaking committee, we developed these clinical diagnostic laboratory NCDs in a prescribed format. Each NCD has the following sections: the official title of the NCD, other names or abbreviations, description, Healthcare Common Procedure Coding System (HCPCS) codes, indications, limitations, International Classification of Diseases, Ninth Edition, Clinical Modification (ICD–9–CM) codes covered by the Medicare program, reasons for denial, ICD–9–CM codes denied, ICD–9–CM codes that do not support medical necessity, sources of information, coding guidelines, documentation requirements, and other comments. For each of the clinical diagnostic laboratory service NCDs (laboratory NCDs), every ICD–9–CM diagnosis code falls into one of the three code lists. The list of covered codes is intended to reflect the coding translation of the conditions enumerated in the narrative indications section of the NCDs. On April 27, 1999, we published a notice (64 FR 22619) outlining our procedures for developing and revisiting NCDs. We further updated the NCD process in a notice published in the Federal Register on September 26, 2003 (68 FR 55634). In the November 23, 2001 final rule (66 FR 58793) for coverage and administrative policies for clinical diagnostic laboratory services, we stated that we will use the NCD process for making changes to the laboratory NCDs. At the conclusion of the NCD decision-making process, decision memoranda will be published on the CMS Web site that announce the policy we intend to issue and discuss the evidence we evaluated and our rationale for the final national coverage E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 70, Number 37 (Friday, February 25, 2005)]
[Notices]
[Pages 9338-9355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9025-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 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 October 2004 through December 2004, relating to the 
Medicare and Medicaid programs. This notice provides information on 
national coverage determinations (NCDs) affecting specific medical and 
health care services under Medicare. Additionally, this notice 
identifies certain devices with investigational device exemption (IDE) 
numbers approved by the Food and Drug Administration (FDA) that 
potentially may be covered under Medicare. Finally, this notice also 
includes listings of all approval numbers from the Office of Management 
and Budget for collections of information in CMS regulations.
    Section 1871(c) of the Social Security Act requires that we publish 
a list of Medicare issuances in the Federal Register at least every 3 
months. Although we are not mandated to do so by statute, for the sake 
of completeness of the listing, and to foster more open and transparent 
collaboration efforts, we are also including all Medicaid issuances and 
Medicare and Medicaid substantive and interpretive regulations 
(proposed and final) published during this 3-month time frame.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may have a specific information need and not be able to determine 
from the listed information whether the issuance or regulation would 
fulfill that need. Consequently, we are providing information contact 
persons to answer general questions concerning these items. Copies are 
not available through the contact persons. (See Section III of this 
notice for how to obtain listed material.)
    Questions concerning items in Addendum III may be addressed to 
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

[[Page 9339]]

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--

--Date published;
--Federal Register citation;
--Parts of the Code of Federal Regulations (CFR) that have changed (if 
applicable);
--Agency file code number; and
--Title of the regulation.

     Addendum V includes completed NCDs, or reconsiderations of 
completed NCDs, from the quarter covered by this notice. Completed 
decisions are identified by the section of the NCDM in which the 
decision appears, the title, the date the publication was issued, and 
the effective date of the decision.
     Addendum VI includes listings of the FDA-approved IDE 
categorizations, using the IDE numbers the FDA assigns. The listings 
are organized according to the categories to which the device numbers 
are assigned (that is, Category A or Category B), and identified by the 
IDE number.
     Addendum VII includes listings of all approval numbers 
from the Office of Management and Budget (OMB) for collections of 
information in CMS regulations in title 42; title 45, subchapter C; and 
title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

    Those wishing to subscribe to program manuals should contact either 
the Government Printing Office (GPO) or the National Technical 
Information Service (NTIS) at the following addresses: Superintendent 
of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 
371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number 
(202) 512-2250 (for credit card orders); or National Technical 
Information Service, Department of Commerce, 5825 Port Royal Road, 
Springfield, VA 22161, Telephone (703) 487-4630.
    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell. 
Additionally, most manuals are available at the following Internet 
address: https://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 https://
www.gpoaccess.gov/fr/, 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 https://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 https://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

[[Page 9340]]

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 NCD publication 
titled ``Treatment of Obesity,'' use CMS-Pub. 100-03, Transmittal No. 
23.

(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: February 14, 2005.
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.
    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); and December 30, 2004 (69 FR 78428).

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

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

         Addendum III--Medicare and Medicaid Manual Instructions
                     [October Through December 2004]
------------------------------------------------------------------------
     Transmittal No.             Manual/Subject/Publication Number
------------------------------------------------------------------------
             Medicare General Information (CMS-Pub. 100-01)
------------------------------------------------------------------------
11.......................  Manual Revision Regarding Waiver of Annual
                            Deductible and Coinsurance for Both
                            Ambulatory Surgery Center Facility, and
                            Ambulatory Surgery Center/Hospital
                            Outpatient Department Physician Services
                            Exceptions to Annual Deductible and
                            Coinsurance.
12.......................  New Policy and Refinements on Billing Non-
                            covered Charges to Fiscal Intermediaries.
                           Applications of Deductible and Coinsurance in
                            Liability and Indemnification Situations.
13.......................  Medicare Termination of Beneficiaries With
                            End-Stage Renal Disease.
14.......................  Scheduled Release for January Updates to
                            Software Programs and Coding/Files.
--------------------------
                Medicare Benefit Policy (CMS-Pub. 100-02)
------------------------------------------------------------------------
23.......................  Revised Requirements for Chiropractic Billing
                            of Active/Corrective Treatment And
                            Maintenance Therapy Full Replacement of CR
                            3063
                           Chiropractor's Services.
                           Necessity of Treatment.
                           Treatment Parameters.
24.......................  Revision of Sec.   300.5.1, Chapter 15 of the
                            Medicare Benefit Policy Manual to Include
                            22x Type of Bill for Diabetes Self-
                            Management Training.
                           Special Claims Processing Instructions for
                            Fiscal Intermediary.
25.......................  Implementation of Coverage of Religious
                            Nonmedical Health Care.
                           Institution Items and Services Furnished in
                            the Home, Medicare Modernization Act Section
                            706.
                           Coverage of Religious Nonmedical Health Care
                            Institution Items and Services Furnished in
                            the Home.
                           Coverage and Payment of Durable Medical
                            Equipment aUnder the Religious Nonmedical
                            Health Care Institution Home Benefit.
                           Coverage and Payment of Home Visits Under the
                            Religious Nonmedical Health Care Institution
                            Home Benefit.
26.......................  Inclusion of Forteo as a Covered Osteoporosis
                            Drug and Clarification of Manual.
                           Instructions Regarding Osteoporosis Drugs.
                           Medical Supplies (Except for Drugs and
                            Biologicals Other Than Covered Osteoporosis
                            Drugs) and the Use of Durable Medical
                            Equipment.
                           Covered Osteoporosis Drugs.
27.......................  New End-Stage Renal Disease Composite Payment
                            Rates Effective January 1, 2005.
28.......................  Hospice Pre-Election Evaluation and
                            Counseling Services.
                           Documentation.
                           Payment.
--------------------------
       Medicare National Coverage Determinations (CMS-Pub. 100-03)
------------------------------------------------------------------------
22.......................  This Transmittal has been rescinded and
                            replaced with Transmittal 25.
23.......................  Treatment of Obesity.
24.......................  Dementia and Neurodegenerative Diseases.
25.......................  Percutaneous Transluminal Angioplasty.
26.......................  Electrocardiographic Services.
--------------------------
              Medicare Claims Processing (CMS-Pub. 100-04)
------------------------------------------------------------------------
305......................  Disabling the Common Working File 57x3
                            Consistency Error Code.
306......................  Full Replacement of CR 3415, 3rd Update to
                            the 2004 Medicare Physician Fee Database.
307......................  This Transmittal has been rescinded and
                            replaced with Transmittal 314.

[[Page 9341]]

 
308......................  Two New Medicare Summary Notice (MSN)
                            Messages for Parenteral Pumps-DMERC Only.
                           Durable Medical Equipment.
309......................  Fiscal Year 2005 Inpatient Prospective
                            Payment System, Long Term Care.
                           Hospital and Other Bill Processing Changes
                            Related to the Inpatient.
                           Prospective Payment System Final Rule.
310......................  Billing Requirements for Positron Emission
                            Tomography Scans for Dementia and
                            Neurodegenerative Diseases.
                           Billing Instructions.
                           Positron Emission Tomography Scan Qualifying
                            Conditions and Healthcare.
                           Common Procedure Coding System Code Chart.
                           Coverage for Positron Emission Tomography
                            Scans for Dementia and Neurodegenerative
                            Disease.
311......................  Instructions for Completion of Form CMS-1450.
                           Health Insurance Portability and
                            Accountability Act Health Care and
                            Coordination of Benefits.
                           Coordination of Benefits.
                           General Instructions for Completion of Form
                            CMS--1450 for Billing.
312......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to confidentiality of
                            instruction.
313......................  Remittance Advice Remark Code and Claim
                            Adjustment Reason Code Update.
314......................  Percutaneous Transluminal Angioplasty.
315......................  Temporary Change in Carrier Jurisdictional
                            Pricing Rules for Purchased Diagnostic
                            Services.
316......................  Clarification of Messages in Chapter 1,
                            Section 10.1.1.1 to Match Official Listing
                            on the WPC-Electronic Data Interchange Web
                            Site.
                           Claims Processing Instructions for Payment
                            Jurisdiction for Claims Received on or After
                            April 1, 2004.
317......................  Clarification to Chapter 26 of the Internet
                            Only Manual.
                           Patient and Insured Information.
                           Provider of Service or Supplier Information.
318......................  Clarification of CR 3176--Payment Amounts for
                            End-Stage Renal Disease Drug.
                           Administration Supplies: Healthcare Common
                            Procedure Coding System A4657 and A4913.
319......................  Comprehensive Outpatient Rehabilitation
                            Facility/Outpatient Physical Therapy.
                           Edit for Billing Inappropriate Supplies.
320......................  Reminder Notice of the Implementation of the
                            Ambulance Transition.
                           Schedule.
321......................  Instructions for Downloading the Medicare Zip
                            Code File.
322......................  Release Medlearn Article for Change Request
                            CR 2813 End-Stage Renal Disease
                            Reimbursement for Automated Multi-Channel
                            Chemistry Test(s).
323......................  Update Regarding the Use of American Dental
                            Association's (ADA) Current Dental
                            Terminology Codes on Medicare Contractor's
                            Web Sites and Other Electronic Media.
                           Displaying Material With Content Development
                            Team Codes.
                           Use of Content Development Team Nomenclature
                            and Descriptors.
                           American Dental Association Copyright Notice.
                           Point and Click License, and Shrink Wrap
                            License.
                           Samples of Content Development Team
                            Nomenclature and Descriptors.
324......................  Quarterly Update to Correct Coding Initiative
                            (CCI) edits, Version 11.0, Effective January
                            1, 2005.
325......................  New Waived Tests--January 1, 2005.
326......................  Invalid Diagnosis Code Editing--Second Phase.
327......................  This Transmittal has been rescinded and
                            replaced with Transmittal 374.
328......................  2005 Annual Update for Skilled Nursing
                            Facility Consolidated Billing for the Common
                            Working File and Medicare Carriers.
329......................  Durable Medical Equipment Regional Carrier
                            Only--Payment to Providers/Suppliers
                            Qualified To Bill Medicare for Prosthetics
                            and Certain Custom-Fabricated Orthotics.
                           Provider Billing for Prosthetics and Orthotic
                            Services.
330......................  Durable Medical Equipment Carrier--
                            Beneficiary Submitted Claims, Process First
                            Claim.
                           General Billing for DME, Prosthetics,
                            Orthotic Devices, and Supplies.
331......................  Durable Medical Equipment Carrier--
                            Beneficiary Submitted Claims, Process First
                            Claim.
332......................  New Policy and Refinements on Billing
                            Noncovered Charges to Fiscal Intermediaries.
                           Provider Billing of Noncovered Charges to
                            Fiscal Intermediaries.
                           General Information on Institutional
                            Noncovered Charges Prior to Billing.
                           Provider-Liable Fully Noncovered Outpatient
                            Claims.
                           Summary of All Types of Institutional No
                            Payment Claims.
                           General Operational Information on
                            Institutional Noncovered Charges.
                           Noncovered Charges on Institutional Demand
                            Bills.
                           Traditional Demand Bills.
                           Summary of Methods for Institutional Demand
                            Billing.
                           Line-Item Modifiers Related to Reporting of
                            Noncovered Charges When Covered and
                            Noncovered Services Are on the Same
                            Institutional Claim.
                           Clarifying Institutional Instructions for
                            Outpatient Therapies Billed As Noncovered,
                            on Other Than Hold Harmless Prospective
                            Payment System Claims, and for Critical
                            Access Hospitals Billing the Same Health
                            Common.
                           Procedure Coding System Requiring Specific
                            Time Increments.
                           Instructions for Noncovered Charges on
                            Institutional Ambulance Claims.
                           Clarification on Notice Requirements Related
                            to Billing Noncovered Charges for
                            ``Bundled'' Institutional Benefits:
                            Laboratory and Rural Health Clinic/Federally
                            Qualified Health Clinic.
333......................  Issued to a specific audience, not posted to
                            the Internet/Intranet due to the
                            confidentiality of instruction.
334......................  Payment of Beneficiary Submitted Flu Claims
                            and Flu Claims Submitted by Non-Enrolled
                            Providers.
335......................  This Transmittal has been rescinded and
                            replaced with Transmittal 400.

[[Page 9342]]

 
336......................  Indian Health Service or Tribal Hospitals
                            including Critical Access Hospital.
                           Payment Methodology for Inpatient Social
                            Admissions and Outpatient Services Occurring
                            During Concurrent Stays.
                           Indian Health Service/Tribal Hospital
                            Inpatient Social Admits.
337......................  Change in Hospital Type of Bill for Billing
                            Diagnostic and Screening Mammographies.
                           Mammography Services.
                           Computer-Aided Detection Add-On Codes.
                           Billing Requirements--Fiscal Intermediary
                            Claims.
                           Rural Health Clinic/Federally Qualified
                            Health Center Claims With Dates of Service
                            Prior to January 1, 2002.
                           Rural Health Clinic/Federally Qualified
                            Health Center Claims With Dates of Service
                            on or After January 1, 2002.
                           Fiscal Intermediary Requirements for
                            Nondigital Screening Mammographies.
                           Mammograms Performed With New Technologies.
338......................  Removal of the Skilled Nursing Facility No
                            Pay File.
339......................  Issued to a specific audience, not posted to
                            the Internet/Intranet due to the Sensitivity
                            of Instruction.
340......................  Annual Update of Healthcare Common Procedure
                            Coding System Codes Used for Home Health
                            Consolidated Billing Enforcement.
341......................  Implementation of the Medicare Physician Fee
                            Schedule (MPFS) National Abstract File for
                            Purchased Diagnostic Tests and
                            Interpretations.
                           Payment Jurisdiction Among Local Carriers for
                            Services Paid Under the Physician Fee
                            Schedule and Anesthesia Services.
                           Payment Jurisdiction for Purchased Services.
                           Payment to Physician or Other Supplier for
                            Purchased Diagnostic Tests--Claims Submitted
                            to Carriers.
                           Payment to Supplier of Diagnostic Tests for
                            Purchased Interpretations.
                           Abstract File for Purchased Diagnostic Tests/
                            Interpretations.
342......................  Change to the Common Working File Skilled
                            Nursing Facility Consolidated.
                           Edits for Ambulance Transports to or From a
                            Diagnostic or Therapeutic Site Ambulance
                            Services.
                           Skilled Nursing Facility Billing.
343......................  Clarification: Modifiers for Transportation
                            of Portable X-rays.
                           Transportation Component.
344......................  Update of Healthcare Common Procedure Coding
                            System Codes and File Names, Descriptions
                            and Instructions for Retrieving the 2005
                            Ambulatory Surgery.
                           Center Healthcare Common Procedure Coding
                            System Deletions and Master Listing.
345......................  This Transmittal is rescinded and replaced
                            with Transmittal 353.
346......................  This Transmittal is rescinded and replaced
                            with Transmittal 352.
347......................  Inpatient Rehabilitation Facility
                            Classification Requirements.
                           Medicare Inpatient Rehabilitation Facility
                            Classification Requirements.
                           Criteria That Must Be Met By Inpatient
                            Rehabilitation Hospitals.
                           Verification Process To Be Used To Determine
                            if the Inpatient Rehabilitation.
                           Facility Met the Classification Criteria.
                           Verification of Compliance Using
                            International Classification of Disease 9th
                            Edition Clinical Modification and Impairment
                            Group Codes.
348......................  January 2005 Quarterly Average Sales Price
                            (ASP) Medicare Part B Drug Pricing File,
                            Effective January 1, 2005.
349......................  This Transmittal is rescinded and replaced
                            with Transmittal 359.
350......................  Editing for Part B Carriers and Durable
                            Medical Equipment Regional Carriers for
                            Duplicate Claims in Process at the Same
                            Time.
351......................  Editing of Hospitals and Skilled Nursing
                            Facilities Part B Inpatient Services.
352......................  Three Places After the Decimal Point for
                            Application Service Provider Drug File.
353......................  Durable Medical Equipment Regional Carrier--
                            Revision to CR 2631.
                           Requirements for Durable Medical Equipment
                            Regional Carrier Claims.
                           Claims Processing Instructions for Payment
                            Jurisdiction for Claims Received on or After
                            April 1, 2004--Durable Medical Equipment
                            Regional Carrier Only.
354......................  DMERC--Beneficiary Submitted Claims, Process
                            First Claim.
355......................  This Transmittal has been rescinded and
                            replaced with Transmittal 375.
356......................  This Transmittal has been rescinded and
                            replaced with Transmittal 376.
357......................  Implementation of Coverage of Religious
                            Nonmedical Health Care Institution.
                           Items and Services Furnished in the Home, MMA
                            section 706.
                           Noncovered Charges on Outpatient Bills.
                           Billing and Payment of Religious Nonmedical
                            Health Care Institution Items and Services
                            Furnished in the Home.
                           Inclusion of Forteo As a Covered Osteoporosis
                            Drug and Clarification of Manual
                            Instructions Regarding Osteoporosis Drugs.
                           Osteoporosis Injections as Home Health Agency
                            Benefit.
358......................  This Transmittal replaces Transmittal 349.
359......................  Annual Update of Healthcare Common Procedure
                            Coding System Codes for Skilled Nursing
                            Facility Consolidated Billing.
360......................  Medicare Modernization Act Drug Pricing
                            Update--Payment Limit for
                            J0207.(Amifostine).
361......................  Update to the Prospective Payment System for
                            Home Health Agencies for Calendar Year 2005.
                           Annual Updates to the Home Health Pricer.
362......................  2005 Annual Update for Clinical Laboratory
                            Fee Schedule and Laboratory Services Subject
                            to Reasonable Charge Payment.
363......................  Common Working File Editing for the Initial
                            Preventive Physical Examination.
364......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to the confidentiality
                            of instruction.
365......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to the confidentiality
                            of instruction.
366......................  This Transmittal has been rescinded and
                            replaced with Transmittal 425.
367......................  Instructions for Completion of Form CMS-1450.
368......................  Fee Schedule Update for 2005 for Durable
                            Medical Equipment, Prosthetics, Orthotics,
                            and Supplies.
369......................  New Case-Mix Adjusted End-Stage Renal Disease
                            (ESRD) Composite.

[[Page 9343]]

 
                           Payment Rates and New Composite Rate
                            Exceptions Window for Pediatric.
                           ESRD Facilities.
                           Outpatient Provider Specific File.
                           Calculation of Case Mix Adjusted Composite
                            Rate.
                           Required Information for In-Facility Claims
                            Paid Under the Composite Rate.
370......................  Updated Billing Instructions for Rural Health
                            Clinics and Federally Qualified.
                           Health Centers.
                           General Billing Requirements.
                           Special Federally Qualified Health Centers
                            Requirements.
                           Reporting of Preventive Services in the
                            Federally Qualified Health Centers.
                           Benefit by Independent Federally Qualified
                            Health Centers.
                           Reporting of Specific Healthcare Common
                            Procedure Coding System Codes for Hospital-
                            based Federally Qualified Health Centers.
                           General Billing Requirements for Preventive
                            Services.
                           Bills Submitted to Fiscal Intermediary.
                           Special Instructions for Independent and
                            Provider-Based Rural Health Clinics/
                            Federally Qualified Health Centers.
                           Claims Submitted to Intermediaries for Mass
                            Immunizations of Influenza and
                           Pneumococcal Pneumonia Vaccine
                           Payment for Computer Add-on Diagnostic and
                            Screening Mammograms for Fiscal Intermediary
                            and Carriers.
                           Rural Health Centers/Federally Qualified
                            Health Centers Claims With Dates of Service
                            Prior to January 1, 2002.
                           Rural Health Centers/Federally Qualified
                            Health Centers Claims With Dates of Service
                            on or After January 1, 2002.
                           Healthcare Common Procedure Coding Codes for
                            Billing.
                           Additional Coding Applicable to Claims
                            Submitted to Fiscal Intermediary.
                           Special Billing Instructions for Rural Health
                            Centers and Federally Qualified.
                           Health Centers.
                           Electrical Stimulation.
                           Electromagnetic Therapy.
371......................  Payment for Referred Laboratory Automated
                            Multi-Channel Chemistry Tests.
                           Claims Processing Requirements for Panel and
                            Profile Tests.
                           History Display.
372......................  New End-Stage Renal Disease Composite Payment
                            Rates Effective Lanuary 1, 2005.
                           Publication of Composite Rates.
                           Determining Individual Facility Composite
                            Rate.
                           Required Information for In-Facility Claims
                            Paid Under the Composite Rate.
                           Epoetin Alfa.
                           Epoetin Alfa Facility Billing Requirement
                            Using UB-92/Form CMS-1450.
                           Payment Amount for Epoetin Alfa.
                           Epoetin Alfa Provided in the Hospital
                            Outpatient Departments.
                           Darbepoetin Alfa for End-Stage Renal Disease
                            Patients.
373......................  Clarification to IOM Chapter 17, Section 80.4
                            Regarding Claims for Blood Clotting Factors.
                           Billing for Blood Clotting Factors.
374......................  This Transmittal has been rescinded and
                            replaced with 388.
375......................  This Transmittal has been rescinded and
                            replaced with 389.
376......................  Hospital Outpatient Prospective Payment
                            System: Misclassified Drugs and Biologicals,
                            Ganciclovir Long Act Implant, Beg Live
                            Intravesical Vac, and Gallium ga 67;
                            Adjustments Due to Misclassification.
377......................  Full Replacement of CR 3308, 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.
                           Provider Liability Instructions.
378......................  Low Osmolar Contrast Material/Laboratory
                            Tests/Payment for Inpatient Servces.
                           Furnished by a Critical Access Hospital.
                           Payment for Inpatient Services Furnished by a
                            Critical Access Hospital.
                           Standard Method--Cost Based Facility
                            Services, With Billing of Carrier for
                            Professional Services.
                           Clinical Diagnostic Laboratory Tests
                            Furnished by Critical Access Hospitals.
379......................  Changes to the Laboratory National Coverage
                            Determination Edit Software for January
                            2005.
380......................  Revisions and Corrections to Chapter 29 of
                            the IOM, Claims Processing Manual--Appeals.
                           CMS Decisions Subject to the Administrative
                            Appeals Process.
                           Who May Appeal.
                           Provider or Supplier Appeals When the
                            Beneficiary Is Deceased.
                           Where To Appeal and Initial Determinations.
                           Social Security Office.
                           Part A Fiscal Intermediary.
                           Providers Right To Appeal Certain Initial
                            Determinations.
                           Part B Carrier (or Fiscal Intermediary Acting
                            As a Carrier).
                           Quality Improvement Organization.
                           Time Limits for Filing Appeals.
                           Amount in Controversy Requirements.
                           Limitation on Liability.
                           Part A Appeals Procedures.
                           Finding Good Cause for Late Filing of Part A
                            Redetermination.
                           General.

[[Page 9344]]

 
                           Establishment of Time Limits for Filing.
                           Conditions Which Establish Good Cause.
                           Procedures To Establish Good Cause.
                           Examples of Situations Where Good Cause
                            Exists.
                           Where Good Cause Is Not Found.
                           Redetermination of a Part A Payment
                            Determination.
                           Place and Manner of Filing Requests for
                            Redeterminations and What Constitutes a
                            Request for Redetermination.
                           Evaluating the Evidence and Making the
                            Redetermination.
                           Preparing the Determination.
                           Completing the Determination.
                           Notice of Further Appeal Rights.
                           Preventing Duplicate Payment in Reversal
                            Cases.
                           Effectuating Favorable Final Appellate
                            Decisions That a Beneficiary Is ``Confined
                            To Home''--Regional Home Health
                            Intermediaries Only.
                           Model Medicare Redetermination Notice.
                           Request for Hearing Under Part A.
                           Right to Representation Under Part A.
                           Reconsiderations, Hearings, and Appeals Where
                            a Quality Improvement.
                           Organization Has Review Responsibility.
                           Reconsiderations.
                           Hearings.
                           Appeals of Institutional Supplementary
                            Medical Insurance (Part B) Claim Decisions.
                           Appeals by Hospitals of Diagnosis Related
                            Group Assignments Under Prospective Payment
                            System--Review of Initial Diagnosis Related
                            Group Assignments.
                           Part B Appeals Procedures for Fiscal
                            Intermediaries and Administrative Law Judge
                            Instructions for Fiscal Intermediaries
                            Redetermination and Hearing Officer (HO)
                            Hearing Supplemental Medical Insurance.
                           Redetermination.
                           What Constitutes a Request for
                            Redetermination & Handling Beneficiary
                            Inquiries.
                           Elements of a Redetermination.
                           Requests for Hearing.
                           Preparation for the Hearing.
                           In-Person and Telephone Hearing Procedures.
                           Request for Hearing Before an Administrative
                            Law Judge.
                           Scope and Effect of Office of Hearings &
                            Appeals, Social Security.
                           Administration Administrative Law Judge
                            Decisions Under Part A.
                           Determining the Amount in Controversy for
                            Administrative Law Judge Hearing.
                           Requests Filed With Social Security
                            Administration.
                           Requests Filed With the Fiscal Intermediary.
                           Action on Incoming Requests for
                            Administrative Law Judge Hearing.
                           Requests for Claim File (Sent by Hearing
                            Office).
                           Examination of Claim File.
                           Prehearing Case Redetermination.
                           Routing the Administrative Law Judge Hearing
                            Claim File.
                           Effectuating Decisions.
                           Effectuating Favorable Final Appellate
                            Decisions That a Beneficiary Is ``Confined
                            To Home''--Regional Home Health
                            Intermediaries Only.Effectuation of Reversal
                            of Decision Where There Was Subsequent
                            Utilization of Benefits in the Same Benefit
                            Period.
                           Effect of Court Decisions.
                           Standard Exhibits Referred to in Sections
                            40.5-50.7.
                           Part B Appeals Procedures--Carriers.
                           Initial Determinations.
                           Steps in the Appeals Process: Overview.
                           Fiscal Intermediary and Carrier
                            Correspondence With Beneficiaries or Other
                            Parties Regarding Appeals.
                           Appointment of Representative--Introduction.
                           Who May Be a Representative.
                           How To Make and Revoke an Appointment.
                           Rights and Responsibilities of a
                            Representative.
                           Timeliness of an Appeal Request and
                            Completeness of Appointment.
                           Incapacitation of Death of Beneficiary.
                           Disclosure of Individually Identifiable
                            Beneficiary Information to Amount in
                            Controversy--General Requirements.
                           Additional Considerations for Calculation of
                            the Amount in Controversy.
                           Aggregation of Claims to Meet the Amount in
                            Controversy.
                           General Procedure To Establish Good Cause.
                           Good Cause Not Found for Beneficiary, or for
                            Provider, Physician, or Other Supplier.
                           General Guidelines.
                           Letter Format.
                           How To Establish Reading Level.
                           Required Elements in Appeals Correspondence.
                           Disclosure of Information to Third Parties.
                           Fraud and Abuse Investigations.
                           Medical Consultants Used.

[[Page 9345]]

 
                           Multiple Beneficiaries.
                           Redetermination--The First Level of Appeal.
                           Filing a Request for Redetermination.
                           Time Limit for Filing a Request for
                            Redetermination.
                           The Redetermination.
                           The Redetermination Determination.
                           Redetermination Determination.
                           Informing the Beneficiary and Provider
                            Communities About the Telephone.
                           Redetermination Process.
                           Redetermination Determination Letters.
                           Hearing Officer Hearing--The Second Level of
                            Appeal.
                           Time Limit for Filing a Request for a Hearing
                            Officer Hearing.
                           Request for a Hearing Officer Hearing Filed
                            Prior to a Redetermination.
                           Timely Processing Requirements.
                           Contractor Responsibilities--General.
                           Requests for Transfer of In-Person Hearing.
                           Acknowledgment of Request for a Hearing
                            Officer Hearing.
                           Case File Development.
                           In-Person Hearing.
                           Telephone Hearing.
                           Qualifications and General Responsibilities.
                           Preparation for the Hearing Officer Hearing.
                           Scheduling the Date, Time and Place of
                            Hearing.
                           Pre-Hearing Review of the Evidence.
                           Forwarding Copy of Case File Prior to
                            Telephone Hearing.
                           The Hearing Officer Hearing Decision
                            Timeliness.
                           Delaying Effectuation.
                           Hearing Officer Reply to Reopening Request.
                           Requests for Part B Administrative Law Judge
                            Hearing.
                           Forwarding Request to Social Security
                            Administration/Office of Hearings & Appeals.
                           Case File Preparation.
                           Effectuation Time Limits.
                           Requests for Case Files.
                           Part A and Part B Quality Improvement and
                            Data Analysis Activities.
                           Workload Data Analysis Program.
                           Quality Improvement Activities.
                           Submitting Summary Reports to CMS.
                           Managing Appeals Workloads.
                           Standard Operating Procedures.
                           Execution of Workload Prioritization.
                           Workload Priorities.
                           Reopening and Revision of Claim
                            Determinations and Decisions.
                           Development of Appeals.
                           How Issues May Arise.
                           Summary of Conditional Under Which a
                            Determination or Decision May Be Reopened.
                           Determining Date of Initial or Appeal
                            Determination or Decision.
                           Who May Reopen an Initial Appeal
                            Determination or Decision.
                           Actions to Permit Reopening Within the 1 Year
                            or 4 Year Period.
                           Good Cause for Reopening.
                           Definitions.
                           Unrestricted Reopening.
                           Reopening an Initial Determination.
                           Reopening a Redetermination or
                            Redetermination Determination.
                           Reopening a Hearing Officer Hearing Decision.
                           Notice of Results of Reopening.
                           Exception to Sending Notice of Revision to
                            Parties--Cases Involving Limitation of
                            Recovery for Beneficiary.
                           Refusal to Reopen Is Not an ``Initial
                            Determination''.
                           Revised Determination or Decision.
382......................  Independent Laboratory Billing for the
                            Technical Component (TC) of Physician
                            Pathology Services to Hospital Patients.
                           Payment for Pathology Services.
383......................  This revision rescinded Transmittal.
384......................  Inpatient Psychiatric Facility Prospective
                            Payment System.
385......................  January 2005 Update of the Hospital
                            Outpatient Prospective Payment System.
                           Summary of Outpatient Prospective Payment
                            System Outpatient Code Editor.
                           Data Changes and Outpatient Prospective
                            Payment System Pricer Logic.
                           Changes; Changes to Payment for Diagnostic
                            Mammography.
386......................  Hospice Pre-election Evaluation and
                            Counseling Services.
387......................  This instruction is to inform the fiscal
                            intermediaries that the January 2005.
                           Outpatient Prospective Payment System
                            Outpatient Code Editor Specifications have
                            been updated with new additions, changes,
                            and deletions.
388......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to confidentiality of
                            instruction.

[[Page 9346]]

 
389......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to confidentiality of
                            instruction.
390......................  Announcement of Medicare Rural Health Clinics
                            and Federally Qualified Health Centers
                            Payment Rate Increase--Skilled Nursing
                            Facility Consolidated.Billing As It Applies
                            to Rural Health Clinics and Federally
                            Qualified Health.Center Services.
391......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to confidentiality of
                            instruction.
392......................  The Supplemental Security Income Medicare
                            Beneficiary Data for Fiscal Year 2003 for
                            Inpatient Rehabilitation Facility
                            Prospective Payment System.
                           LIP Adjustment: The Supplemental Security
                            Income Medicare Beneficiary Data for
                            Inpatient Rehabilitation Facility Paid Under
                            Prospective Payment System.
393......................  ZThis revision is rescinded and replaced with
                            revision 401.
394......................  This revision is rescinded and replaced with
                            revision 396.
395......................  Ambulance Fee Schedule--Medical Conditions
                            List.
396......................  New Dispensing/Supply Fee Codes for Oral Anti-
                            Cancer, Oral Anti-Emetic, Immunosuppressive,
                            and Inhalation Drugs.
                           Pharmacy Supply Fee.
397......................  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 Carriers Drugs.
                           Calculation of the Average Wholesale Price.
                           Detailed Procedures for Determining Average
                            Wholesale Prices and the Drug.Payment
                            Allowable 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.
398......................  Issued to a specific audience, not posted to
                            Internet/Intranet due to confidentiality of
                            instruction.
399......................  Expansion of the Existing Interrupted Stay
                            Policy Under Long Term Care.
                           Hospital Prospective Payment System.
400......................  Incorrect Reporting of Miles Time Units
                            Services Indicator When Drugs are Billed
                            Using a National Drug Code.
                           Miles/Times/Units/Services.
                           Methodology of Coding Number of Services,
                            Miles Times Units Services.
                           Count and Miles Times Units Services
                            Indicator Fields.
401......................  2005 Part B Deductible Update to the Back
                            Page of Medicare Summary Notices.
                           Back of the Medicare Summary Notices--
                            Carriers and Intermediaries.
402......................  January Update to the Medicare Outpatient
                            Code Editor Version 20.1 for Bills from
                            Hospitals That Are Not Paid Under the
                            Outpatient Prospective Payment System.
403......................  January 2005 Update of the Hospital
                            Outpatient Prospective Payment System:
                            Billing Devices That Do Not Have
                            Transitional Pass-Through Status, and That
                            Are Not Classified As New Technology
                            Ambulatory Payment Classification Groups.
                           Requirements That Hospitals Report Device
                            Codes on Claims on Which They Report
                            Specified Procedures.
                           Edits for Claims On Which Specified
                            Procedures Are To Be Reported With Device.
                           Codes.
404......................  January 2005 Update of the Hospital
                            Outpatient Prospective Payment System:
                            Changes to Coding and Payment for Drug
                            Administration.
                           Billing and Payment for Drugs and
                            Biologicals.
                           Coding and Payment for Drug Administration.
405......................  Emergency Change to Carrier Instructions for
                            the End-Stage Renal Disease.
                           50/50 Rule Implementation.
406......................  Update to Health Care Claims Status Category
                            Codes and Health Care Claim Status Codes for
                            Use With the Health Care Claim Status
                            Request and Response ASC X12N 276/277.
407......................  Hospital Billing for Repetitive Services.
                           Inpatient Billing From Hospitals and Skilled
                            Nursing Facilities.
                           Frequency of Billing for Outpatie

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