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Notice

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July 2002 Through September 2002

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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 Start Printed Page 79110general 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.

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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 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.

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, 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:

  • 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 instruction or many. 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 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.

  • 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.
  • 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.)

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield. VA 22161, Telephone (703) 487-4630.

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

B. Regulations and Notices

Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual Start Printed Page 79111copies 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).

C. Rulings

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

D. CMS'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:

  • Titles XI, XVIII, and XIX of the Act.
  • CMS-related regulations.
  • CMS manuals and monthly revisions.
  • CMS program memoranda.

The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at http:www.ssa.gov/​OP_​Home/​ssact/​comp-toc.htm) The remaining portions of CD-ROM are updated on a monthly basis.

Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.

Any cost 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.

IV. 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.

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(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.

End Signature

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)
420Provider Services
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Intermediary Manual
Part 3—Claims Process
(CMS Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
1858Claims Processing Timeliness
1859Coding for Adequacy of Hemodialysis
1860Payment for Services Furnished by a Critical Access Hospital
1861Definitions
1862ICD-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)
145Provider Services
Carriers Manual
Part 3—Program Administration
(CMS Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
1757Durable Medical Equipment Regional Carriers Mandatory Assignment for Drug Claims
1758Payment Requirements
Roster Claim Form
1759Splitting Claims for Processing
1760Participating Physician/Supplier Report
Purpose and Scope
Definitions of Columns One Through Eight
Definitions of Lines One Through One Hundred Fifteen
Checking Reports
Exhibits
1761Completing 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
1762Diabetes 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
1763The “Do Not Forward” Initiative
1764Services and Supplies
Incident to Physician's Professional Services
Services of Nonphysician Personnel Furnished Incident to Physicians Services
1765Medicare Physician Fee Schedule Database 2003 File Layout
Medicare Physician Fee Schedule Database Status Indicators
Maintenance Process for the Medicare Physician Fee Schedule Database
1766Anesthesia Services and Teaching Certified Registered Nurse Anesthetist
1767Entitlement and Enrollment
1768Identifying a Screening Mammography Claim and a Diagnostic
Mammography Claim
1769Method for Computing Fee Schedule Amounts
Coding for Diagnostic Tests
1770General Resolution of Common Working File 5232 Rejects
1771Mandatory 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-02-057Medicare Part A Skilled Nursing Facility Prospective Payment System Update
A-02-058Inpatient Rehabilitation Facility Annual Update: Prospective Payment System Pricer Changes for FY 2003
A-02-059Medicare Program—Update to the Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice Pricer for FY 2003
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A-02-060Revision to Billing for Swing Bed Services Under Skilled Nursing Facility Prospective Payment System
A-02-061Medicare Program—Update to the Prospective Payment System for Home Health Agencies for Fiscal Year 2003
A-02-062Applicable Bill Type for Ambulance Services (Revenue Code 540)
A-02-063Scheduled Release for October Updates to Software Programs and Pricing/Coding Files
A-02-064Excluding Hospitals that Provide Part B Only Services to Their Inpatients from the Outpatient Prospective Payment System
A-02-065-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-Department of Veterans Affairs Claims Adjudication Services Project: Systems Changes Needed
A-02-067Production 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-02-068Enhancements to Home Health Prospective Payment System Claims Processing
A-02-069-Health Insurance Protability and Accountability Act Institutional 837 Health Care Claim Additional Implementation Direction
A-02-070Health Insurance Portability and Accountability Act Transaction 835v4010 Completion Update
A-02-071Updated Instruction on Receipt and Processing of Non-Covered Charges on Other Than Part A Inpatient Claims
A-02-072Implementation of the Provider Enrollment, Chain and Ownership System
A-02-073Financial Report Instructions for the Fiscal Intermediary Shared System Recovery Tracking System
A-02-074Hospital Outpatient Prospective Payment System Implementation Instructions
A-02-075Admitting Diagnosis for Observation for the Outpatient Prospective Payment System
A-02-076October 2002 Update to the Hospital Outpatient Prospective Payment System
A-02-077Intermediaries Must Adjust Their Translators for Reporting Line Item Dates, and Healthcare Common Procedure Coding System Codes for Part A Outpatient Claims
A-02-078Health Insurance Portability and Accountability Act Institutional 837 Health Care Claim—Direct Data Entry Updates
A-02-079Data Fields that the Fiscal Intermediaries are Required to Enter into the Provider Enrollment, Chain and Ownership System
A-02-080October Medicare Outpatient Code Editor Specifications Version 18.0 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
A-02-081Modification of Audit and Cost Report Settlement Expectations in Change Request 1468
A-02-082October Outpatient Code Editor Specifications Version (V3.2)
A-02-083System Tracking for Audit and Reimbursement Instructions: End Stage Renal Disease Audits and Hospice Cost Reports
A-02-084Fiscal Year 2003 Prospective Payment System Hospital, Skilled Nursing Facility and Other
A-02-085Applicable Bill Types for Ambulance Services (Revenue Code 540)
A-02-086The Supplemental Income/Medicare Beneficiary Data for Fiscal Year 2001 For Inpatient Prospective Payment System Hospitals
A-02-087Clarification of Provider Billing Requirements Under the Outpatient Prospecitve Payment System
A-02-088Installation of Version 28.0 of the Provider Statistical and Reimbursement Report
A-02-089Temporary Procedures for Cost-Based Payments for Certified Registered Nurse Anesthetists Services Furnished by Outpatient Prosepctive Payment System Hospitals
A-02-090File 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-02-091Modifications to the Health Care Eligibility Benefit Response (271) and Direct Data Entry Screens for Home Health Agencies and Hospice Providers
A-02-092Corrections 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-02-093Instructions 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-02-039Common Working File Category Changes
B-02-040Common Working File Category Changes
B-02-041Billing for Implanted Durabale Medical Equipment, Prosthetic Devices, Replacement Parts, Accessories and Supplies
B-02-042Transmittal B-02-042 was resscinded and will not be used in the future
B-02-043Acceptance of Special Characters in the Common Working File and the Durable Medical Equipment Regional Carrier Standard System
B-02-044Change in Jurisdiction for Topical Hyperbaric Oxygen Chamber
B-02-045VIPS Medicare System Implemntation to Process ICD-9-CM Codes Using Date of Service and Not Date of Receipt
B-02-046Updating the Carrier Locality Edit at the Common Working File
B-02-047Durable Medical Equipment Regional Carrier—Appeal Messages on Medicare Summary Notice and Medicare Remit Notice
B-02-048Reasonable Charge Data Disclosure Requirements for Ambulance Services
B-02-049Common Working File Change for Billing for Glucose Test Strips and Supplies—Follow-up to Change Request 1612
B-02-050Additional Remark Code for Claims of Therapy Services Possibly Subject to Home Health Conslidated Billing
B-02-051Implementation of the Health Insurance Portability and Accountability Act Health Care Eligiblity Benefit Inquiry/Response Transaction (270/271) Standard
B-02-052Implementation 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-02-053Implementation of the ASC X12N 278 Version 4010 Implmentation Guide for Electronic Referral Certification and Authorization
B-02-054Sending Copies of Appeal Notices to Appointed Representatives, Including the Amount in Controversy Remaining in Review Determination Letters, and Using Bullets in Appeals Correspondence
B-02-055Updates to the Place of Service Code Set
Start Printed Page 79114
B-02-056Furlong Lawsuit Settlement Payments
B-02-057Addition to Two “WW” Codes to Identify a New Source for Etoposide
B-02-058Changes to Correct Coding Edits, Version 9.0, Effective January 1, 2003
B-02-059Activation of the Automated Unsolicited Response for Skilled Nursing Facility Consolidated Billing and Global Payment Demonstrations
B-02-060Payment Policy When More Than One Patient is Onboard an Ambulance
B-02-061Schedule 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-02-091New Waived Tests—June 17, 2002
AB-02-092Procedures Subject to Home Health Consolidated Billing
AB-02-093Coverage and Billing for Intravenous Immune Globulin (IVIg) for the Treatment of Autoimmune Muccocutaneous Blistering Diseases
AB-02-094Disclosure Desk Reference for Call Centers
AB-02-095Prohibition on New Trading Partner Agreements with Certain Entities For the Purpose of Coordination of Benefits
AB-02-096Coverage and Billing of the Diagnosis and Treatment of Peripheral Neuropathy With Loss of Protective Senation in People with Diabetes
AB-02-097Carrier, 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-02-098Process for Entering Local Medical Review Policies and Certain Articles and Frequently Asked Questions into the Medicare Coverage Database
AB-02-099Standardize the CICS Level, CICS Transaction Server 1.3 to be Utilized by All Medicare Contractors
AB-02-100Modification of Medicare Policy for Erythropoietin
AB-02-101Changes to Common Working File Edits for Skilled Nursing Facility Consolidated Billing
AB-02-102Medicare 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-02-103Expand 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-02-104October Quarterly Update for 2002 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
AB-02-105Medical Review of Medicare Payments for Nail Debridgement Services
AB-02-106Medicare Summary Notice—Inclusion of Appeals Information, Removal of Fraud References and Office of Inspector General's Hotline Number
AB-02-107Modify Application of “I” Validity Medicare Secondary Payor Records to the Common Working File by Medicare Contractors
AB-02-108Clarification 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-02-109Common Working File, Fiscal Intermediary and Carrier Edits and Policy Clarification for Peripheral Neuropathy With Loss of Protective Sensation in People with Diabetes
AB-02-110Implementation of National Coverage Determinations Regarding Clinical Determinations Regarding Clinical Diagnostic Laboratory Services
AB-02-111Implementation of Certain Initial Determination and Appeal Provisions Within § 521 of the Medicare, Medicaid and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000
AB-02-112Final Update to the 2002 Medicare Physician Fee Schedule Database
AB-02-113Elimination of Official Level III Healthcare Common Procedure Coding System Codes/Modifiers and Unapproved Local Codes/Modifiers and Unapproved Local Codes/Modifiers
AB-02-114Advanced 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-02-115Expanded Coverage of Position Emission Tomography Scans and Related Claims Processing Changes
AB-02-116Data Center Testing and Production—Electronic Correspondence Referral System User Manual 5.0
AB-02-117Transition Schedule for Implementation of the Ambulance Fee Schedule
AB-02-118Notice of Interest Rate for Medicare Overpayment and Underpayments
AB-02-119Medicare Coordinated Care Demonstration Payment for Railroad Retirement Beneficiaries
AB-02-120Coding Instructions for IN-111 Zevalin and Y-90 Zevalin
AB-02-121Provider/Supplier Plan Quarterly Report Format
AB-02-122Appeals Quality Improvement and Data Analysis Activities
AB-02-123Information on Medicare+Choice Private Fee-for-Service Plans—Information Only
AB-02-124Updates of Rates and Wage Index for Ambulatory Surgical Center Payment Effective October 1, 2002
AB-02-125Provider Education Article: Durable Medical Equipment Ordered With Surrogate Unique Physician Identification Number
AB-02-126Establishing 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-02-127Program Management Provider/Supplier Education and Training
AB-02-128Coverage and Billing for Percutaneous Image-Guided Breast Biopsy
AB-02-129Claims Processing Requirements for Clinical Diagnostic Laboratory Services Based on the Negotiated Rulemaking
Start Printed Page 79115
AB-02-130Definitions of Ambulance Services
AB-02-131Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule
AB-02-132Year 2003 Healthcare Common Procedure Coding System Annual Update Reminder
AB-02-133Publication and Maintenance of a Directory of Electronic Billing Ventors
Hospital Manual
(CMS Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
787Coding for Adequacy of Hemodialysis
788Payment for Services Furnished by a Critical Access Hospital
789General Information About the Program
790ICD-9-CM Coding for Diagnostic Tests
Home Health Agency Manual
(CMS—Pub. 11)
(Superintendent of Documents No. HE 22.8/5)
302Combined to the Home
303General Information About the Program
Skilled Nursing Facility Manual
(CMS—Pub. 12)
(Superintendent of Documents No. HE 22.8/3)
373Coverage and Patient Classification
374General Information About the Program
Hospice Manual
(CMS—Pub. 21)
(Superintendent of Documents No. HE 22.8/18)
65General Information About the Program
Outpatient Physical Therapy and Comprehensive
Outpatient Rehabilitation Facility Manual
(CMS—Pub. 9)
(Superintendent of Documents No. HE 22.8/9)
16General Information About the Program
Coverage Issues Manual
(CMS—Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
157Photodynamic Therapy
Photosensitive Drugs
158Speech Generating Devices
159Percutaneous 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)
37General Information About the Program
Rural Dialysis Facility Manual
(Non-Hospital Operated)
(CMS—Pub. 29)
(Superintendent of Documents No. HE 22.8/13)
93Coding 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)
9Hospital and Hospital Healthcare Complex Cost Report
Start Printed Page 79116
Medicare Program Integrity Manual
(CMS—Pub. 100-8)
27Contractor must review Local Medical Review Policy
28Local Medical Review Policies Reconsideration Process
29Introduction
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
Start Printed 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)
10Quality 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
Start Printed 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
11Lock-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
12Definitions
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)
06-02Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—June 2002
07-02Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—July 2002
09-02Report 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)

Publication dateFR Vol. 67 pageCFR part(s)File code*Regulation title
07/01/20024407342 CFR 412, and 413CMS-1069-F2Medicare Program; Prospective Payment System for Inpatient Rehabilitation Facilities; Correcting Amendment.
07/17/20024694942 CFR Chap. IVCMS-1227-NMedicare Program; Town Hall Meeting on the Outcome Assessment Information Set (OASIS).
Start Printed Page 79119
07/26/20024880042 CFR 405CMS-3074-F2Medicare Program; End-Stage Renal Disease: Removing of Waiver Conditions for Coverage Under a State of Emergency in the Houston, Texas Area.
07/26/20024880142 CFR 413CMS-1883-F3Medicare Program; Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled Nursing Facilities and Elimination of Reclassifications; Technical Correction.
07/26/20024880242 CFR 146CMS-2033-IFCTechnical Change to Requirements for the Group Health Insurance Market; Non-Federal Governmental Plans Exempt From HIPPA Title I Requirements.
07/26/20024883942 CFR Chap. IVCMS-6012-N2Medicare Program; Establishment of The Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricate Orthotics; Meeting Announcement.
07/26/20024884042 CFR 413CMS-1199-PMedicare Program; Electronic Submission of Cost Reports.
07/26/200248905CMS-4037-NMedicare Program; Meeting of the Advisory Panel on Medicare Education—September 26, 2002.
07/31/200249798CMS-1202-NMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.
08/01/200249928CMS-1205-NMedicare Program; Inpatient Rehabilitation Facility Prospective Payment System for FY 2003 Rates.
08/01/20024998242 CFR 405, 412, 413, and 485CMS-1203-FMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates.
08/09/20025209242 CFR 405, 410, and 419CMS-1206-PMedicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports.
08/16/20025364442 CFR 405, 410 and 419CMS-1206-P (OFR correction)Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports; Correction.
08/22/20025453242 CFR 438CMS-2104-FMedicare Program; Medicaid Managed Care: New Provisions.
08/22/20025453442 CFR 400, 405, and 426CMS-3063-PMedicare Program; Review of National Coverage Determinations and Local Coverage Determinations.
08/23/200254660CMS-1216-NMedicare Program; September 23 and 24, 2002, Meeting of the Practicing Physicians Advisory Council and Request for Nominations.
08/23/200254657CMS-2140-FNMedicare and Medicaid Programs; Approval of Deeming Authority for Critical Access Hospitals by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
08/23/200254659CMS-3098-NMedicare Program; Meeting of the Executive Committee of the Medicare Coverage Advisory Committee—September 25, 2002.
08/30/200255851CMS-2136-PNMedicare Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2002.
08/30/20025595442 CFR 412, 413 and 476CMS-1177-FMedicare Program; Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates.
08/30/200256092CMS-1211-NMedicare Program; Hospital Wage Index for Fiscal Year 2003.
09/04/20025661842 CFR 403CMS-4027-FMedicare Program; Medicare-Endorsed Prescription Drug Card Assistance Initiative.
09/27/20026099342 CFR 408CMS-1221-FMedicare Program; Supplementary Medical Insurance Premium Surcharge Agreements.
09/27/200261116CMS-4043-NMedicare Program; Solicitation for Proposals for the Physician Group Practice Demonstration.
Start Printed Page 79120
09/27/200261130CMS-9014-NMedicare 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]

SectionTitleEffective date
45-30Photosensitive DrugsJanuary 1, 2003.
45-32Levocarnitine for the Treatment of Carnitine Deficiency in ESRD PatientsJanuary 1, 2003.
35-77Neuromuscular ElectricalApril 1, 2003.
35-102Electrical Stimulation for Wound HealingApril 1, 2003.

Program Memoranda

PM numberTitleEffective date
No items for this quarterly notice.

Joint Letter and Federal Register Publication

DateTitleEffective 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 memoTitleCIM 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 BStart Printed 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

End Supplemental Information

[FR Doc. 02-32197 Filed 12-26-02; 8:45 am]

BILLING CODE 4120-01-M