Medicaid and Medicare: Program issuances and coverage decisions; quarterly listing,
[Federal Register: December 27, 2002 (Volume 67, Number 249)]
[Notices]
[Page 79109-79121]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de02-108]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-9015-N]
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July 2002 Through September 2002
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2002, through September 2002, relating to the Medicare and Medicaid programs. This notice also provides information on national coverage determinations affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare.
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, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.
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
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general questions concerning these items. Copies are not available through the contact persons. (See section III of this notice for how to obtain listed material.)
Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, (410) 786-5252.
Questions concerning national coverage determinations should be directed to Shana Olshan, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, (410) 786-3122.
Questions concerning Investigational Device Exemptions items in Addendum VI may be addressed to Sharron Hippler, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C5-13- 27, 7500 Security Boulevard, Baltimore, MD 21244-1850, (410) 786-4633.
Questions concerning all other information may be addressed to Misty Whitaker, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-10-24, 7500 Security Boulevard, Baltimore, MD 21244-1850, (410) 786-3087.
SUPPLEMENTARY INFORMATION:
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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 these 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, fiscal intermediaries and carriers 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, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the 3-month timeframe.
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How To Use the Addenda
This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, national coverage determinations, and Food and Drug Administration-approved investigational device exemptions published during the timeframe to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare Coverage Issues Manual may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the procedures used in making national coverage determinations may review the April 27, 1999, publication (64 FR 22619). In this publication, the 1989 proposed rule affecting national coverage procedures and decisions (54 FR 4302) was withdrawn, and the procedures for national coverage determinations established.
To aid the reader, we have organized and divided this current listing into six addenda:
[sbull] Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
[sbull] Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
[sbull] 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 instruction or many. Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.
[sbull] Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarters 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.
[sbull] Addendum V includes completed national coverage determinations from the quarter covered by this notice. Completed decisions are identified by title, a brief description, effective date, and section in the appropriate Federal publication.
[sbull] Addendum VI includes listings of the Food and Drug Administration-approved investigational device exemption categorizations, using the investigational device exemption numbers the Food and Drug Administration 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 investigational device exemption number.)
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How To Obtain Listed Material
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Manuals
Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield. VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: http://cms.hhs.gov/manuals/default.asp.
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Regulations and Notices
Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual
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copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.access.gpo.gov/nara/index.html , by using local WAIS client software, or by telnet to swais.access.gpo.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).
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Rulings
We publish rulings on an infrequent basis. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http://cms.hhs.gov/rulings.
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CMS's Compact Disk-Read Only Memory (CD-ROM)
Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, as the stock number is: 717-319-00000-3. The following material is on the CD-ROM disk:
[sbull] Titles XI, XVIII, and XIX of the Act.
[sbull] CMS-related regulations.
[sbull] CMS manuals and monthly revisions.
[sbull] CMS program memoranda.
The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at http:www.ssa.gov/OP_Home/ssact/comp-toc.htm ) The remaining portions of CD-ROM are updated on a monthly basis.
Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re- visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.
Any cost reports 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.
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How To Review Listed Material
Transmittal or Program Memoranda can be reviewed at a Local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL.
In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library.
Superintendent of Documents numbers for each CMS publication are shown in Addendum III, along with the CMS publication and transmittal numbers. To help FDLs locate the materials, use the Superintendent of Documents number, plus the transmittal number. For example, to find the Part 3--Program Administration, (CMS Pub. 14-3) transmittal entitled ``Payment Requirements,'' use the Superintendent of Documents No. HE 22.8/7 and the transmittal number 1758.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare-- Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program)
Dated: December 16, 2002. 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.
August 11, 1998 (63 FR 42857) September 16, 1998 (63 FR 49598) December 9, 1998 (63 FR 67899) May 11, 1999 (64 FR 25351) November 2, 1999 (64 FR 59185) December 7, 1999 (64 FR 68357) January 10, 2000 (65 FR 1400) May 30, 2000 (65 FR 34481) June 28, 2002 (67 FR 43762) September 27, 2002 (67 FR 61130)
Addendum II--Description of Manuals, Memoranda, and HCFA 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 Medicare Coverage Issues Manual was published on August 21, 1989, at 54 FR 34555. (Please note that in this publication the 1989 proposed rule referred to, concerning the criteria for national coverage determinations, was withdrawn (64 FR 22619)). A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 6, 1992 (57 FR 47468).
Addendum III.--Medicare and Medicaid Manual Instructions [July 2002 Through September 2002]
Transmittal No.
Manual/Subject/Publication No.
Intermediary Manual Part 2--Audits, Reimbursement Program Administration (CMS Pub. 13-2) (Superintendent of Documents No. HE 22.8/6-2)
420
[sbull Provider Services ]
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Intermediary Manual Part 3--Claims Process (CMS Pub. 13-3) (Superintendent of Documents No. HE 22.8/6)
1858
[sbull Claims Processing Timeliness ] 1859
[sbull Coding for Adequacy of Hemodialysis ] 1860
[sbull Payment for Services Furnished by a Critical ] Access Hospital 1861
[sbull Definitions ] 1862
[sbull ICD-9-CM Coding for Diagnostic Tests ]
Carriers Manual Part 3--Program Administration (CMS Pub. 14-2) (Superintendent of Documents No. HE 22.8/7-3)
145
[sbull Provider Services ]
Carriers Manual Part 3--Program Administration (CMS Pub. 14-3) (Superintendent of Documents No. HE 22.8/7)
1757
[sbull Durable Medical Equipment Regional Carriers ] Mandatory Assignment for Drug Claims 1758
[sbull Payment Requirements ] ...... Roster Claim Form 1759
[sbull Splitting Claims for Processing ] 1760
[sbull Participating Physician/Supplier Report ] ...... Purpose and Scope ...... Definitions of Columns One Through Eight ...... Definitions of Lines One Through One Hundred Fifteen ...... Checking Reports ...... Exhibits 1761
[sbull Completing Quarterly Report on Provider ] Enrollment ...... Checking Reports ...... Type of Provider ...... Completing Lines Twelve Through Seventeen-- Reason for Denial ...... Completing Lines Eighteen Through Twenty-Two- Reason for Return ...... Exhibits 1762
[sbull Diabetes Outpatient Self-Management Training ] Services ...... General Conditions of Coverage and Diabetes Training Hours ...... Beneficiaries Eligible for Coverage ...... Provider/Supplier Eligibility to Provide the Training ...... Quality Standards ...... Enrollment of Entities Other Than Durable Medical Equipment Prosthetic, Orthotics & Supplies ...... Health Common Procedure Coding System Coding ...... General Payment Conditions 1763
[sbull The ``Do Not Forward'' Initiative ] 1764
[sbull Services and Supplies ] ...... Incident to Physician's Professional Services ...... Services of Nonphysician Personnel Furnished Incident to Physicians Services 1765
[sbull Medicare Physician Fee Schedule Database ] 2003 File Layout ...... Medicare Physician Fee Schedule Database Status Indicators ...... Maintenance Process for the Medicare Physician Fee Schedule Database 1766
[sbull Anesthesia Services and Teaching Certified ] Registered Nurse Anesthetist 1767
[sbull Entitlement and Enrollment ] 1768
[sbull Identifying a Screening Mammography Claim ] and a Diagnostic ...... Mammography Claim 1769
[sbull Method for Computing Fee Schedule Amounts ] ...... Coding for Diagnostic Tests 1770
[sbull General Resolution of Common Working File ] 5232 Rejects 1771
[sbull Mandatory Assignment and Other Requirements ] for Home Dialysis Supplies and Equipment Paid Under Method II
Program Memorandum Intermediaries (CMS Pub. 60A) Superintendent of Documents No. HE 22.8/6-5)
A-02-057
[sbull Medicare Part A Skilled Nursing Facility ] Prospective Payment System Update A-02-058
[sbull Inpatient Rehabilitation Facility Annual ] Update: Prospective Payment System Pricer Changes for FY 2003 A-02-059
[sbull Medicare Program--Update to the Hospice ] Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice Pricer for FY 2003
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A-02-060
[sbull Revision to Billing for Swing Bed Services ] Under Skilled Nursing Facility Prospective Payment System A-02-061
[sbull Medicare Program--Update to the Prospective ] Payment System for Home Health Agencies for Fiscal Year 2003 A-02-062
[sbull Applicable Bill Type for Ambulance Services ] (Revenue Code 540) A-02-063
[sbull Scheduled Release for October Updates to ] Software Programs and Pricing/Coding Files A-02-064
[sbull Excluding Hospitals that Provide Part B Only ] Services to Their Inpatients from the Outpatient Prospective Payment System A-02-065-
[sbull Implementation of the Transmission Control ] Protocol/Internet Protocol for the Health Insurance Portability and Accountability Act Health Care Eligibility Benefit Inquiry And Response Transaction (270/271) Standard A-02-066-
[sbull Department of Veterans Affairs Claims ] Adjudication Services Project: Systems Changes Needed A-02-067
[sbull Production of Flat Files to Enable Centers ] for Medicare and Medicaid Services to Populate the Online Survey, Certification and Reporting Online Survey, Certification and Reporting System with the Provider Taxpayer Identification Number A-02-068
[sbull Enhancements to Home Health Prospective ] Payment System Claims Processing A-02-069-
[sbull Health Insurance Protability and ] Accountability Act Institutional 837 Health Care Claim Additional Implementation Direction A-02-070
[sbull Health Insurance Portability and ] Accountability Act Transaction 835v4010 Completion Update A-02-071
[sbull Updated Instruction on Receipt and ] Processing of Non-Covered Charges on Other Than Part A Inpatient Claims A-02-072
[sbull Implementation of the Provider Enrollment, ] Chain and Ownership System A-02-073
[sbull Financial Report Instructions for the Fiscal ] Intermediary Shared System Recovery Tracking System A-02-074
[sbull Hospital Outpatient Prospective Payment ] System Implementation Instructions A-02-075
[sbull Admitting Diagnosis for Observation for the ] Outpatient Prospective Payment System A-02-076
[sbull October 2002 Update to the Hospital ] Outpatient Prospective Payment System A-02-077
[sbull Intermediaries Must Adjust Their Translators ] for Reporting Line Item Dates, and Healthcare Common Procedure Coding System Codes for Part A Outpatient Claims A-02-078
[sbull Health Insurance Portability and ] Accountability Act Institutional 837 Health Care Claim--Direct Data Entry Updates A-02-079
[sbull Data Fields that the Fiscal Intermediaries ] are Required to Enter into the Provider Enrollment, Chain and Ownership System A-02-080
[sbull October Medicare Outpatient Code Editor ] Specifications Version 18.0 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System A-02-081
[sbull Modification of Audit and Cost Report ] Settlement Expectations in Change Request 1468 A-02-082
[sbull October Outpatient Code Editor ] Specifications Version (V3.2) A-02-083
[sbull System Tracking for Audit and Reimbursement ] Instructions: End Stage Renal Disease Audits and Hospice Cost Reports A-02-084
[sbull Fiscal Year 2003 Prospective Payment System ] Hospital, Skilled Nursing Facility and Other A-02-085
[sbull Applicable Bill Types for Ambulance Services ] (Revenue Code 540) A-02-086
[sbull The Supplemental Income/Medicare Beneficiary ] Data for Fiscal Year 2001 For Inpatient Prospective Payment System Hospitals A-02-087
[sbull Clarification of Provider Billing ] Requirements Under the Outpatient Prospecitve Payment System A-02-088
[sbull Installation of Version 28.0 of the Provider ] Statistical and Reimbursement Report A-02-089
[sbull Temporary Procedures for Cost-Based Payments ] for Certified Registered Nurse Anesthetists Services Furnished by Outpatient Prosepctive Payment System Hospitals A-02-090
[sbull File Descriptions and Instructions for ] Retrieving the 2003 Physician, Clinical Lab, Durable Medical Equipment, Prosthetics/ Orthotics and Supplies, and Therapy Fee Schedule Payment Amounts through CMS's Mainframe Telecommunications Systems A-02-091
[sbull Modifications to the Health Care Eligibility ] Benefit Response (271) and Direct Data Entry Screens for Home Health Agencies and Hospice Providers A-02-092
[sbull Corrections to: Changes to the Hospital ] Inpatient Prospective Payment Systems and Rates and Costs of Graduate Medical Education, etc.; as Published in the Federal Register, FY 2002 (66 FR 39828, August 1, 2001) and FY 2003 (67 FR 49982, August 1, 2002) A-02-093
[sbull Instructions for Implementing the Long-Term ] Care Hospital Prospective Payment System
Program Memorandum Carriers (CMS Pub. 60B) (Superintendent of Documents No. HE 22.8/6-5)
B-02-039
[sbull Common Working File Category Changes ] B-02-040
[sbull Common Working File Category Changes ] B-02-041
[sbull Billing for Implanted Durabale Medical ] Equipment, Prosthetic Devices, Replacement Parts, Accessories and Supplies B-02-042
[sbull Transmittal B-02-042 was resscinded and will ] not be used in the future B-02-043
[sbull Acceptance of Special Characters in the ] Common Working File and the Durable Medical Equipment Regional Carrier Standard System B-02-044
[sbull Change in Jurisdiction for Topical ] Hyperbaric Oxygen Chamber B-02-045
[sbull VIPS Medicare System Implemntation to ] Process ICD-9-CM Codes Using Date of Service and Not Date of Receipt B-02-046
[sbull Updating the Carrier Locality Edit at the ] Common Working File B-02-047
[sbull Durable Medical Equipment Regional Carrier-- ] Appeal Messages on Medicare Summary Notice and Medicare Remit Notice B-02-048
[sbull Reasonable Charge Data Disclosure ] Requirements for Ambulance Services B-02-049
[sbull Common Working File Change for Billing for ] Glucose Test Strips and Supplies--Follow-up to Change Request 1612 B-02-050
[sbull Additional Remark Code for Claims of Therapy ] Services Possibly Subject to Home Health Conslidated Billing B-02-051
[sbull Implementation of the Health Insurance ] Portability and Accountability Act Health Care Eligiblity Benefit Inquiry/Response Transaction (270/271) Standard B-02-052
[sbull Implementation of the National Council for ] Prescription Drug Programs Telecommunications Standard Version 5.1 and the Equivalent Batch Standard Version for Retail Pharmacy Drug Transactions B-02-053
[sbull Implementation of the ASC X12N 278 Version ] 4010 Implmentation Guide for Electronic Referral Certification and Authorization B-02-054
[sbull Sending Copies of Appeal Notices to ] Appointed Representatives, Including the Amount in Controversy Remaining in Review Determination Letters, and Using Bullets in Appeals Correspondence B-02-055
[sbull Updates to the Place of Service Code Set ]
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B-02-056
[sbull Furlong Lawsuit Settlement Payments ] B-02-057
[sbull Addition to Two ``WW'' Codes to Identify a ] New Source for Etoposide B-02-058
[sbull Changes to Correct Coding Edits, Version ] 9.0, Effective January 1, 2003 B-02-059
[sbull Activation of the Automated Unsolicited ] Response for Skilled Nursing Facility Consolidated Billing and Global Payment Demonstrations B-02-060
[sbull Payment Policy When More Than One Patient is ] Onboard an Ambulance B-02-061
[sbull Schedule for Completing the Calendar year ] 2003 Fee Schedule Updates and the Participating Physician Enrollment Procedures
Program Memorandum Intermediaries/Carriers (CMS Pub. 60A/B) (Superintendent of Documents No. HE 22.8/6-5)
AB-02-091
[sbull New Waived Tests--June 17, 2002 ] AB-02-092
[sbull Procedures Subject to Home Health ] Consolidated Billing AB-02-093
[sbull Coverage and Billing for Intravenous Immune ] Globulin (IVIg) for the Treatment of Autoimmune Muccocutaneous Blistering Diseases AB-02-094
[sbull Disclosure Desk Reference for Call Centers ] AB-02-095
[sbull Prohibition on New Trading Partner ] Agreements with Certain Entities For the Purpose of Coordination of Benefits AB-02-096
[sbull Coverage and Billing of the Diagnosis and ] Treatment of Peripheral Neuropathy With Loss of Protective Senation in People with Diabetes AB-02-097
[sbull Carrier, Durable Medical Equipment Regional ] Carrier Intermediary and Regional Home Health Intermediary Processing Requirements for Claims Edited by Common Working File for Medicare Beneficiaries in State or Local Custody Under a Penal Authority AB-02-098
[sbull Process for Entering Local Medical Review ] Policies and Certain Articles and Frequently Asked Questions into the Medicare Coverage Database AB-02-099
[sbull Standardize the CICS Level, CICS Transaction ] Server 1.3 to be Utilized by All Medicare Contractors AB-02-100
[sbull Modification of Medicare Policy for ] Erythropoietin AB-02-101
[sbull Changes to Common Working File Edits for ] Skilled Nursing Facility Consolidated Billing AB-02-102
[sbull Medicare Secondary Payer Debt Referral and ] Write Off Closed Instructions; (1) Expansion and Clarification of Medicare Secondary Payer Debt Collections Improvement Act of 1996 Activities; (2) Additional ``Write--Off--Closed Instructions'' (Supplemental Instructions for PM AB-01-24) AB-02-103
[sbull Expand Standard Date Format and Review ] Common Working File Y2K Wrapper Logic for Beneficiary Cross Reference Internal Files and Satellite File Header and Response Records AB-02-104
[sbull October Quarterly Update for 2002 Durable ] Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule AB-02-105
[sbull Medical Review of Medicare Payments for Nail ] Debridgement Services AB-02-106
[sbull Medicare Summary Notice--Inclusion of ] Appeals Information, Removal of Fraud References and Office of Inspector General's Hotline Number AB-02-107
[sbull Modify Application of ``I'' Validity ] Medicare Secondary Payor Records to the Common Working File by Medicare Contractors AB-02-108
[sbull Clarification of Medicare Contractor ] Financial Reporting Instructions Outlined in Section 1900--Section 19602.21 of the Medicare Intermediary Manual and Section 4900--Section 4960.14 of the Medicare Carriers Manual (Issued May 2001) AB-02-109
[sbull Common Working File, Fiscal Intermediary and ] Carrier Edits and Policy Clarification for Peripheral Neuropathy With Loss of Protective Sensation in People with Diabetes AB-02-110
[sbull Implementation of National Coverage ] Determinations Regarding Clinical Determinations Regarding Clinical Diagnostic Laboratory Services AB-02-111
[sbull Implementation of Certain Initial ] Determination and Appeal Provisions Within Sec. 521 of the Medicare, Medicaid and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000 AB-02-112
[sbull Final Update to the 2002 Medicare Physician ] Fee Schedule Database AB-02-113
[sbull Elimination of Official Level III Healthcare ] Common Procedure Coding System Codes/ Modifiers and Unapproved Local Codes/ Modifiers and Unapproved Local Codes/ Modifiers AB-02-114
[sbull Advanced Beneficiary Notice and Durable ] Medical Equipment Prosthetics, Orthotics & Supplies Refund Requirements-- Implementation of Form CMS-R-131 Advance Beneficiary Notice, and of Limits on Beneficiary Liability for Medicare Equipment and Supplies AB-02-115
[sbull Expanded Coverage of Position Emission ] Tomography Scans and Related Claims Processing Changes AB-02-116
[sbull Data Center Testing and Production-- ] Electronic Correspondence Referral System User Manual 5.0 AB-02-117
[sbull Transition Schedule for Implementation of ] the Ambulance Fee Schedule AB-02-118
[sbull Notice of Interest Rate for Medicare ] Overpayment and Underpayments AB-02-119
[sbull Medicare Coordinated Care Demonstration ] Payment for Railroad Retirement Beneficiaries AB-02-120
[sbull Coding Instructions for IN-111 Zevalin and Y- ] 90 Zevalin AB-02-121
[sbull Provider/Supplier Plan Quarterly Report ] Format AB-02-122
[sbull Appeals Quality Improvement and Data ] Analysis Activities AB-02-123
[sbull Information on Medicare+Choice Private Fee- ] for-Service Plans--Information Only AB-02-124
[sbull Updates of Rates and Wage Index for ] Ambulatory Surgical Center Payment Effective October 1, 2002 AB-02-125
[sbull Provider Education Article: Durable Medical ] Equipment Ordered With Surrogate Unique Physician Identification Number AB-02-126
[sbull Establishing a Uniform Process for the ] Preparation and Mailing of Case Files From The Contractor, the Office of Hearings and Appeals, of the Social Security Administration AB-02-127
[sbull Program Management Provider/Supplier ] Education and Training AB-02-128
[sbull Coverage and Billing for Percutaneous Image- ] Guided Breast Biopsy AB-02-129
[sbull Claims Processing Requirements for Clinical ] Diagnostic Laboratory Services Based on the Negotiated Rulemaking
[[Page 79115]]
AB-02-130
[sbull Definitions of Ambulance Services ] AB-02-131
[sbull Clarification of Medicare Policy Regarding ] the Implementation of the Ambulance Fee Schedule AB-02-132
[sbull Year 2003 Healthcare Common Procedure Coding ] System Annual Update Reminder AB-02-133
[sbull Publication and Maintenance of a Directory ] of Electronic Billing Ventors
Hospital Manual (CMS Pub. 10) (Superintendent of Documents No. HE 22.8/2)
787
[sbull Coding for Adequacy of Hemodialysis ] 788
[sbull Payment for Services Furnished by a Critical ] Access Hospital 789
[sbull General Information About the Program ] 790
[sbull ICD-9-CM Coding for Diagnostic Tests ]
Home Health Agency Manual (CMS--Pub. 11) (Superintendent of Documents No. HE 22.8/5)
302
[sbull Combined to the Home ] 303
[sbull General Information About the Program ]
Skilled Nursing Facility Manual (CMS--Pub. 12) (Superintendent of Documents No. HE 22.8/3)
373
[sbull Coverage and Patient Classification ] 374
[sbull General Information About the Program ]
Hospice Manual (CMS--Pub. 21) (Superintendent of Documents No. HE 22.8/18)
65
[sbull General Information About the Program ]
Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation Facility Manual (CMS--Pub. 9) (Superintendent of Documents No. HE 22.8/9)
16
[sbull General Information About the Program ]
Coverage Issues Manual (CMS--Pub. 6) (Superintendent of Documents No. HE 22.8/14)
157
[sbull Photodynamic Therapy ] [sbull Photosensitive Drugs ] 158
[sbull Speech Generating Devices ] 159
[sbull Percutaneous Image-Guided Breast Biopsy ]
Rural Health Clinic Manual & Federally Qualified Health Centers Manual (CMS--Pub. 27) (Superintendent of Documents No. HE 22.8/19:985)
37
[sbull General Information About the Program ]
Rural Dialysis Facility Manual (Non-Hospital Operated) (CMS--Pub. 29) (Superintendent of Documents No. HE 22.8/13)
93
[sbull Coding for Adequacy of Hemodialysis ]
Provider Reimbursement Manual--Part 2 Provider Cost Reporting Forms and Instructions Chapter 36/Form CMS-2552-96 (CMS Pub. 15-2-36)
9
[sbull Hospital and Hospital Healthcare Complex ] Cost Report
[[Page 79116]]
Medicare Program Integrity Manual (CMS--Pub. 100-8)
27
[sbull Contractor must review Local Medical Review ] Policy 28
[sbull Local Medical Review Policies ] Reconsideration Process 29
[sbull Introduction ] ...... Definitions Related to Enrollment ...... Applicant versus Provider/Supplier ...... General Instructions ...... Forms ...... Contractors ...... Forms Disposition ...... Application Sectional Instructions for Carriers ...... Processing the Application ...... Identification ...... Adverse Legal Actions ...... Practice Location ...... Ownership and Managing Control Information (Organizations) ...... Ownership and Managing Control Information (Individuals) ...... Chain Home Office Information ...... Billing Agency ...... Electronic Claims Submission Information ...... Staffing Company ...... Surety Bond Information ...... Capitalization Requirement for Home Health Agencies ...... Contact Person ...... Penalties for Falsifying Information on This Enrollment Application ...... Certification Statement ...... Delegate Official ...... Attachment ...... Ambulance Services Suppliers--Attachment 1 ...... State License Information ...... Description of Vehicle ...... Qualification of Crew ...... Certified Basic Life Support ...... Certified Advanced Life Support ...... Medical Director Information ...... Independent Diagnostic Testing Facilities-- Attachment 2 ...... Entities That Must Enroll as Independent Diagnostic Testing Facilities ...... Review of Attachment 2, Independent Diagnostic Testing Facility ...... Enrollment Checks ...... Special Considerations ...... Reassignment of Benefits--Form CMS-855R ...... Individual Reassignment of Medicare Benefits ...... Supplier Identification ...... Individual Practitioner Identification ...... Practice Location ...... Statement of Termination ...... Reassignment of Benefits Statement ...... Attestation Statement ...... Enrolling Certified Suppliers Who Enroll With Carrier ...... Managed Care Organization ...... Application Sectional Instructions for Intermediaries ...... Processing the Application ...... Provider Identification ...... Adverse Legal Actions ...... Practice Location ...... Special Processing Situations ...... Community Metal Health Centers ...... Benefit Improvement and Protection Act of 2000 Provisions ...... Community Mental Health Centers Enrollment and Change of Ownership Site ...... Visits ...... Process ...... Deactivation of Billing Numbers of Inactive Community Mental Health Centers ...... State Survey/Regional Offices Process ...... Changes in Requested Information--New Form CMS-855 Data ...... Change Requirement ...... Procedures for Request for Additional Information, Approval, Denial, or Transmission of Recommendations ...... Request for Additional Information ...... Approval
[[Page 79117]]
...... Denials ...... Failure to Sign and/or Date the Application Processing ...... Matrix ...... Verification and Validation of Information ...... Fraud Investigation Database ...... Healthcare Integrity and Protection Data Bank ...... Social Security Death Index ...... Uncovering Fraud and Abuse ...... General Services Administration Debarment ...... Special Processing Situations ...... Mass Immunizers Who Roster Bill ...... Opt-Out Physicians ...... Enrollment of Hospitals, Assignment of Billing Numbers ...... Railroad Retirement Board ...... Mass Immunization and Roster Billers ...... Site Visits ...... Administrative Appeals ...... Tracking Requirements ...... Retention of Records ...... Provider/Suppliers Education ...... Web Site ...... Security Safeguards ...... Documentation
Managed Care Manual (CMS-Pub. 100-16) (Superintendent of Documents No. HE 22)
10
[sbull Quality Assessment and Performance ] Improvement Projects ...... General ...... Non-Clinical Focus Areas-Non-Clinical Focus Areas Applicable Enrollees Quality ...... Improvement System for Managed Care Document Standard ...... Quality Assessment and Performance Improvement Projects ...... Phase In Requirements ...... Ongoing Requirements Document Standard ...... Focus Areas ...... Clinical Focus Area Applicable to All Enrollees ...... Attributes of Quality Assessment and Performance Improvement ...... Selection of Topics for Medicare+Choice Selected Projects and Local ...... Marketplace Initiatives ...... Sources of Information ...... Medicare+Choice Using Physician Incentive Plans ...... Quality Indicators ...... Significant, Sustained Improvements ...... Sustained Improvement Over Time ...... Types of Quality Assurance Program Improvement Projects ...... National Quality Assurance Program Improvement Projects ...... Medicare+Choice Organization Selected Quality Assurance Program ...... Improvement Projects ...... Other Quality Assurance Program Improvement Projects ...... Process for Centers for Medicare and Medicaid Services Multi-Year Quality ...... Assurance ...... Program Improvement Projects Approval ...... Evaluation of Quality Assurance Program Improvement Projects ...... Terminology ...... Deeming Requirements ...... General Rule ...... Obligations of Deemed Medicare+Choice Organizations ...... Deemed Status and Center for Medicare and Medicaid Services Surveys ...... Removals of a Medicare+Choice Organization's Deemed Status ...... Centers for Medicare and Medicaid Services Role ...... Oversight of Accrediting Organizations ...... Obligations of Accrediting Organizations with Deeming Authority ...... Application Requirements ...... Reporting Requirement ...... Reconsideration of Application Denials, Removal of All Approval of Deeming Authority, or Non-Renewals of Deeming Authority ...... Informal Hearing Procedures ...... Informal Hearing Findings ...... Final Reconsideration Determinations
[[Page 79118]]
...... Background ...... Specifics Applicable to Consumer Assessment of Health Plans Study and Health Plan ...... Employer Data and Information Set ...... Healthplan Employer Data Information Sets Submission Requirements ...... The Medicare Health Outcomes Survey Requirements ...... Medicare Consumer Assessment of Health Plan Survey Requirements for Enrollees And Disenrollees 11
[sbull Lock-in Requirements/Selecting a Primary ] Care Physician--How to Access Care in a Health Maintenance Organization's Emergency Care Cross Reference to Quality Improvement System for Managed Care 2.3.1.7 ...... Appeal Rights ...... Benefits and Plan Premium Information ...... Final Verifications Review Process ...... Guidelines for Outreach Program ...... Submission Requirements ...... Center for Medicare and Medicaid Services Review/Approval Process ...... Model Direct Mail Letter ...... Answers to Frequently Asked Questions About Promotional Activities ...... Relationship of Value-Added Items and Services to Benefits and Other Operational Considerations ...... Non Benefit Providing Third Party Marketing Materials ...... Marketing Material Requirements for Non- English Speaking Populations Standard 2.3.3.2 12
[sbull Definitions ] ...... Eligibility for Enrollment in Medicare+Choice Plans ...... Completion of Enrollment Form ...... Election Periods and Effective Dates ...... Annual Election Period ...... Open Enrollment Period ...... Open Enrollment Period Through 2004 ...... Open Enrollment Period Through 2005 ...... Open Enrollment Period in 2006 and Beyond ...... Open Enrollment for Newly Eligible Individuals in 2005 and Beyond ...... Special Election Period ...... Special Election Period for Exceptional Conditions ...... Special Election Period for Beneficiaries Aged 65 ...... Effective Date of Coverage ...... Effective Date of Voluntary Disenrollment ...... Enrollment Procedures ...... Format of Enrollment Forms ...... Medicare+Choice Organizational Denial of Enrollment ...... After the Effective Date of Coverage ...... Procedures After Reaching Capacity ...... Disenrollment Procedures ...... Voluntary Disenrollment by Member ...... Medigap Guaranteed Issue Notification Requirements ...... Members Who Change Residence ...... Failure to Pay Premiums ...... Disenrollment Procedure for Employer Group Health Plans ...... Multiple Transactions ...... Cancellation of Enrollment ...... Reinstatement Due to Mistaken Disenrollment Made By Member
Medicare/Medicaid Sanction--Reinstatement Report (CMS Pub. 69)
06-02
[sbull Report of Physicians/Practitioners, ] Providers and/or Other Health Care Suppliers Excluded/Reinstated--June 2002 07-02
[sbull Report of Physicians/Practitioners, ] Providers and/or Other Health Care Suppliers Excluded/Reinstated--July 2002 09-02
[sbull Report of Physicians/Practitioners, ] Providers and/or Other Health Care Suppliers Excluded/Reinstated--August 2002
Addendum IV.--Regulation Documents Published in the Federal Register (July 2002 through September 2002)
FR Vol. 67 Publication date
page
CFR part(s)
File code*
Regulation title
07/01/2002..................
44073 42 CFR 412, and 413 CMS-1069-F2........ Medicare Program; Prospective Payment System for Inpatient Rehabilitation Facilities; Correcting Amendment. 07/17/2002..................
46949 42 CFR Chap. IV.... CMS-1227-N......... Medicare Program; Town Hall Meeting on the Outcome Assessment Information Set (OASIS).
[[Page 79119]]
07/26/2002..................
48800 42 CFR 405......... CMS-3074-F2........ Medicare Program; End- Stage Renal Disease: Removing of Waiver Conditions for Coverage Under a State of Emergency in the Houston, Texas Area. 07/26/2002..................
48801 42 CFR 413......... CMS-1883-F3........ Medicare Program; Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled Nursing Facilities and Elimination of Reclassifications; Technical Correction. 07/26/2002..................
48802 42 CFR 146......... CMS-2033-IFC....... Technical Change to Requirements for the Group Health Insurance Market; Non-Federal Governmental Plans Exempt From HIPPA Title I Requirements. 07/26/2002..................
48839 42 CFR Chap. IV.... CMS-6012-N2........ Medicare Program; Establishment of The Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricate Orthotics; Meeting Announcement. 07/26/2002..................
48840 42 CFR 413......... CMS-1199-P......... Medicare Program; Electronic Submission of Cost Reports. 07/26/2002..................
48905 ................... CMS-4037-N......... Medicare Program; Meeting of the Advisory Panel on Medicare Education--September 26, 2002. 07/31/2002..................
49798 ................... CMS-1202-N......... Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- Update. 08/01/2002..................
49928 ................... CMS-1205-N......... Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for FY 2003 Rates. 08/01/2002..................
49982 42 CFR 405, 412, CMS-1203-F......... Medicare Program; 413, and 485.
Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates. 08/09/2002..................
52092 42 CFR 405, 410, CMS-1206-P......... Medicare Program; and 419.
Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports. 08/16/2002..................
53644 42 CFR 405, 410 and CMS-1206-P (OFR Medicare Program; 419.
correction).
Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports; Correction. 08/22/2002..................
54532 42 CFR 438......... CMS-2104-F......... Medicare Program; Medicaid Managed Care: New Provisions. 08/22/2002..................
54534 42 CFR 400, 405, CMS-3063-P......... Medicare Program; Review and 426.
of National Coverage Determinations and Local Coverage Determinations. 08/23/2002..................
54660 ................... CMS-1216-N......... Medicare Program; September 23 and 24, 2002, Meeting of the Practicing Physicians Advisory Council and Request for Nominations. 08/23/2002..................
54657 ................... CMS-2140-FN........ Medicare and Medicaid Programs; Approval of Deeming Authority for Critical Access Hospitals by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). 08/23/2002..................
54659 ................... CMS-3098-N......... Medicare Program; Meeting of the Executive Committee of the Medicare Coverage Advisory Committee-- September 25, 2002. 08/30/2002..................
55851 ................... CMS-2136-PN........ Medicare Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2002. 08/30/2002..................
55954 42 CFR 412, 413 and CMS-1177-F......... Medicare Program; 476.
Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates. 08/30/2002..................
56092 ................... CMS-1211-N......... Medicare Program; Hospital Wage Index for Fiscal Year 2003. 09/04/2002..................
56618 42 CFR 403......... CMS-4027-F......... Medicare Program; Medicare-Endorsed Prescription Drug Card Assistance Initiative. 09/27/2002..................
60993 42 CFR 408......... CMS-1221-F......... Medicare Program; Supplementary Medical Insurance Premium Surcharge Agreements. 09/27/2002..................
61116 ................... CMS-4043-N......... Medicare Program; Solicitation for Proposals for the Physician Group Practice Demonstration.
[[Page 79120]]
09/27/2002..................
61130 ................... CMS-9014-N......... Medicare and Medicaid Programs: Quarterly Listing of Program Issuances--April 2002 Through June 2002.
*N=General Notice; PN=Proposed Notice; NC=Notice with Comment Period; FN=Final Notice; P=Notice of Proposed Rulemaking (NPRM); F=Final Rule; FC=Final Rule with Comment Period; CN=Correction Notice; IFC=Interim FInal Rule with Comment Period; GNC=General Notice with Comment Period.
Addendum V--National Coverage Determinations (April 2002 Through June 2002)
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 became effective 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 impending decisions or, in some cases, explain why it was not appropriate to issue a NCD. We identify completed decisions by title, effective date, and section of the publication where the decision can be found. Also, please note that in some cases more than one NCD was made affecting single procedure. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at http://cms.hhs.gov/coverage.
National Coverage Decisions for Quarterly Notice [Coverage Issues Manual--CMS Pub. 06]
Section
Title
Effective date
45-30................................... Photosensitive Drugs............ January 1, 2003. 45-32................................... Levocarnitine for the Treatment January 1, 2003. of Carnitine Deficiency in ESRD Patients. 35-77................................... Neuromuscular Electrical........ April 1, 2003. 35-102.................................. Electrical Stimulation for Wound April 1, 2003. Healing.
Program Memoranda
PM number
Title
Effective date
No items for this quarterly notice.
Joint Letter and Federal Register Publication
Date
Title
Effective date
No items for this quarterly notice.
Decision Memoranda Announcing Maintenance of Existing National Coverage Determination
The following decision memoranda announce the agency's intention to issue NCDs or they announce the agency's determination that NCDs are inappropriate and thus reasonable and necessary determinations are left to contractor discretion. The relevant sections of the Coverage Issues Manual, however, have not yet been revised. The revisions will occur at a later date.
Date of memo
Title
CIM section
No items for this quarterly notice.
Addendum VI--Categorization of Food and Drug Administration-Allowed Investigational Device Exemptions
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. Also, under the new categorization process to assist CMS, the Food and Drug Administration assigns each device with a Food and Drug Administration-approved investigational device exemption to one of two categories. 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 information presents the device number and category (A or B).
Investigational Device Exemption Numbers, 2nd Quarter 2002
IDE/Category G010013 B
[[Page 79121]]
G010134 B G010188 B G010328 B G020002 B G020025 A G020030 B G020046 B G020048 B G020050 B G020051 B G020052 B G020054 B G020056 A G020057 B G020061 B G020062 B G020063 B G020064 B G020065 B G020068 B G020070 B G020072 B G020073 B G020075 B G020079 B G020080 B G020082 B G020085 B G020087 B G020090 B G020092 B G020094 B G020096 B G020097 B G020098 B G020099 B G020100 B G020106 B G020107 B G020108 B G020109 B G020112 B G020113 B G020114 B G020116 A G020119 B G020121 B G020122 B G020126 B G020127 A G020130 B G020132 B G020133 B G020135 B G020165 B
[FR Doc. 02-32197 Filed 12-26-02; 8:45 am]
BILLING CODE 4120-01-M
