Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October 2002 Through December 2002

Federal RegisterMar 28, 2003

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9016-N]

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October 2002 Through December 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 October 2002 through December 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 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 Sharon 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 Margie Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, (410) 786-4678.

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of 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 time frame.

II. How to Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, 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 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).

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, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:

• Titles XI, XVIII, and XIX of the Act.

• CMS-related regulations.

• CMS manuals and monthly revisions.

• CMS program memoranda.

The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at

http://www.ssa.gov/OP_Home/ssact/comp-toc.htm

.) The remaining portions of CD-ROM are updated on a monthly basis.

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

Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL.

In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most

Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library.

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—Claims Process, (CMS Pub. 13-3) transmittal entitled “Hearing Aide Exclusion,” use the Superintendent of Documents No. HE 22.8/6 and the transmittal number 1868.

(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: March 18, 2003.

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)

December 27, 2002 (67 FR 79109)

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

An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the 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 16, 1992 (57 FR 47468).

Addendum III.—Medicare and Medicaid Manual Instructions

[October 2002 Through December 2002]

Transmittal

No.

Manual/Subject/Publication number

Intermediary Manual

Part 3—Claims Process

(CMS Pub. 13-3)

(Superintendent of Documents No. HE 22.8/6)

1863

•

Prospective Payment System Pricer Program

Provider-Specific Payment Data

Provider-Specific Data Record Layout and Description

1864

•

Mammography Screening

Diagnostic and Screening Mammography Performed With New Technologies

1865

•

Overpayments for Provider Services—General

1866

•

Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines

1867

•

Immunosuppressive Drugs Furnished to Transplant Patients

1868

•

Hearing Aide Exclusion

1869

•

Payment for Services Furnished by a Critical Access Hospital

1870

•

Payment for Services Furnished by a Critical Access Hospital

1871

•

Heart Transplants

Carriers Manual

Part 3—Claims Process

(CMS Pub. 14-3)

(Superintendent of Documents No. HE 22.8/7)

1772

•

Type of Service

1773

•

Durable Medical Equipment Regional Carriers Only—Appeals of Duplicate Claims

Introduction to the Appeals Process

1774

•

Home Dialysis Patients' Options for Billing

Payment for Method II Home Dialysis Supplies When the Beneficiary is an Inpatient

1775

•

Identifying a Screening Mammography Claim and a Diagnostic Mammography Claim

Diagnostic and Screening Mammography Performed With New Technologies

1776

•

Evaluation and Management Services Codes—General

1777

•

Overpayments—General

1778

•

Healthcare Common Procedure Coding System Coding

1779

•

Coding Physician Specialty

Coding Type of Supplier and Non-Physician Practitioners

1780

•

Supervising Physicians in Teaching Settings

1781

•

Hearing Aid Exclusion

1782

•

Mandatory Assignment and Other Requirements for Home Dialysis Supplies and Equipment Paid Under Method II

1783

•

Type of Service

1784

•

Recovery Where Fraud Is Suspected

Carriers Manual

Part 4—Professional Relations

(CMS Pub. 14-4)

(Superintendent of Documents No. HE 22.8/7-4)

•

Surrogate Unique Physician Identification Number

Program Memoranda

Intermediaries (CMS Pub. 60A)

(Superintendent of Documents No. HE 22.8/6-5)

A-02-094

•

Annual Desk Review Program for Hospital Wage Data: Cost Reporting Periods Beginning on or after October 1, 1999, Through September 30, 2000 (Fiscal Year 2004 Wage Index)

A-02-095

•

Production Dates for the Provider Statistical and Reimbursement Report and Extension of Due Date for Filing Provider Cost Reports for Providers Having Their Claims Processed by the Arkansas Part A Standard System and Request for Wage Data for the FY 2004 Wage Index

A-02-096

•

Payment of Skilled Nursing Facility Claims for Beneficiaries Disenrolling from Terminating Medicare+Choice Plans Who Have Not Met the 3-Day Hospital Stay Requirement

A-02-097

•

Special Handling of New “K” Codes K0556, K0557, K0558, and K0559

A-02-098

•

Changes in Transitional Outpatient Payment for 2003

A-02-099

•

Scheduled Release for January Updates to Software Programs and Pricing/Coding Files

A-02-100

•

Installation of Version 27.4 of the Provider Statistical and Reimbursement Report

A-02-101

•

Changes to the Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update as Published in the Federal Register, Fiscal Year 2001 (66 FR 39572, July 31, 2001), and Transmittal A-01-144, December 20, 2001 Hospice Wage Index Fiscal Year 2003, as published in the Federal Register (67 FR 56092, August 30, 2002) Update to the Prospective Payment System for Home Health Agencies for FY 2003; as Published in the

Federal Register

, (67 FR 43616, June 28, 2002)

A-02-102

•

Medicare Certified Hospices—Clarification of Acceptable Parameters for Some Contractual Arrangements

A-02-103

•

New Electronic Remittance Advice Coding for Home Health Prospective Payment System Adjustments

A-02-104

•

Provider Education Article: Home Health Agencies Responsibilities Regarding Patient Notification

A-02-105

•

Removal of Common Working File Edit on Non-Covered Hospice Claims

A-02-106

•

Provider Education Article: Hospitals Responsibilities Re: Patient Notification at Discharge Planning and Home Health Consolidated Billing

A-02-107

•

Revisions to Common Working File Editing to Accommodate Home Health Partial Episode Payment Claims and Rescheduling of Payment Adjustment Utility

A-02-108

•

Multiple Patient Ambulance Transport

A-02-109

•

Cost Based Payment for Certified Registered Nurse Anesthetists' Services Furnished by Outpatient Prospective Payment System Hospitals

A-02-110

•

Financially Required Changes for the Fiscal Intermediary Standard System Paid Claim File

A-02-111

•

October 2002 Update to the Hospital Outpatient Prospective Payment System—Correction—This instruction replaces PM A-02-076 (CR 2298) issued on August 7, 2002.

A-02-112

•

Program Integrity Management Reporting System for Part A—Phase1

A-02-113

•

Transmittal A-02-113 Has Been Rescinded

A-02-114

•

Revisions to the Outpatient Prospective Payment System Pricer Software and Outpatient Code Editor for Blood Deductible and Technical Charges

A-02-115

•

Medical Nutrition Therapy Services for Beneficiaries With Diabetes or Renal Disease—POLICY CHANGE

A-02-116

•

Long Term Care Hospital Prospective Payment System: Requirements for Provider Education and Training

A-02-117

•

Correction to Updated Instruction on Receipt and Processing on Non-Covered Charges on Other Than Part A Inpatient Claims (Transmittal A-02-071)

A-02-118

•

Annual Update of Healthcare Common Procedure Coding System Codes for Skilled Nursing Facility Consolidated Billing Enforcement, Updated Skilled Nursing Facility Help File

A-02-119

•

0001 Revenue Line Direction for the Health Insurance Portability and Accountability Act Institutional 837 Health Care Claim

A-02-120

•

Change in Requirements for Medicare Payment for Low Osmolar Contrast Material Under the Outpatient Prospective Payment System

A-02-121

•

Skilled Nursing Facility Adjustment Billing: Adjustments to Health Insurance Prospective Payment System Codes Resulting From Minimum Data Set Corrections

A-02-122

•

Notice Regarding Cost-to-Charge Ratios and Inpatient Outlier Payments

A-02-123

•

Hospital Billing for Immunosuppressive Drugs Furnished to Transplant Patients—ACTION

A-02-124

•

Necessary Changes to Implement Special Add-On Payments for New Technologies

A-02-125

•

Installation of Version 29.0 of the Provider Statistical and Reimbursement Reporting System

A-02-126

•

Instructions Regarding Hospital Outlier Payments

A-02-127

•

Indian Health Service Hospital Payment Rates for Calendar Year 2002

Program Memorandum

Carriers

(CMS Pub. 60B)

(Superintendent of Documents No. HE 22.8/6-5)

B-01-062

•

Payment to Registered Dietitians for Diabetes Outpatient Self-Management Training Services

B-02-063

•

Annual Updating of ICD -9-CM Codes Must Be Date of Services Driven

B-02-064

•

Viable Information Processing System Implementation to Process ICD-9-CM Codes Using Date of Service and Not Date of Receipt

B-02-065

•

Durable Medical Equipment Regional Carriers-Establishment Common Working File Override for Legitimate Duplicate Claims

B-02-066

•

Ambulance Services: Maintaining Point-of-Pickup Zip Code

B-02-067

•

Revision to Messages for Skilled Nursing Facility Consolidated Billing and Implementation of Common Working File Edits for Clinical Social Workers for Skilled Nursing Facility Consolidated Billing

B-02-068

•

Revised X12N 4010 837 Professional Flat File

B-02-069

•

Messages for Use With Drug Claims

B-02-070

•

Reporting of Admission Date and Additional Edit Requirements for the X12N 837 (Version 4010) Coordination of Benefits Transaction

B-02-071

•

Use of the National Drug Code for Drug Claims at the Durable Medical Equipment Regional Carriers

B-02-072

•

Calendar Year 2003 Participation Enrollment and Medicare Participating Physicians and Supplies Directory Procedures

B-02-073

•

Durable Medical Equipment Regional Carriers-Establishment Common Working File Override for Legitimate Duplicate Claims

B-02-074

•

Clarification on System Changes in Change Request 2299

B-02-075

•

Carrier Review of Payment Amounts for Portable X-Ray Transportation Services (HCPCS code R0070)—Request

B-02-076

•

Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers

B-02-077

•

Program Integrity Management Reporting System for Part B

B-02-078

•

Medical Review Progressive Corrective Action—ACTION

B-02-079

•

Contractor Reporting of Operational and Workload Data for Electronic Data Interchange and Manual Transactions

B-02-080

•

Medicare Status Code System Standard System Financial Data Report Requirements for the Production Performance Monitoring System, Pulse System

B-02-081

•

Migrate Medicare Carrier Provider/Supplier Enrollment Data From the Existing Carrier Provider Enrollment System into the Provider Enrollment Chain Ownership System

B-02-082

•

Migrate Medicare Carrier Provider/Supplier Enrollment Data From the Existing Carrier Provider Enrollment System into the Provider Enrollment Chain Ownership System and Shut Down All Provider Enrollment Functions in Percutaneous Electrical Nerve Stimulation

B-02-083

•

Create Import/Export Functionality Between the Unique Provider Identification Number System and the Provider Enrollment Chain Ownership System

B-02-084

•

Create Import/Export Functionality Between the Medicare Claims System and the Provider Enrollment Chain Ownership System

B-02-085

•

Process All Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System. Modify the Medicare Claims System to Incorporate All Claim Payment and Provider Correspondence Functionality That Is Included in the Provider Enrollment System But Will Not Be a Part of Provider Enrollment System. Shut Down All Provider Enrollment Functions in Provider Enrollment System

B-02-086

•

Create Import/Export Functionality Between the Viable Medicare System and the Provider Enrollment Chain Ownership System

B-02-087

•

Skilled Nursing Facility Consolidated Billing—New Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

B-02-088

•

Changes to Correct Coding Edits, Version 9.1, Effective April 1, 2003

B-02-089

•

Further Instructions Regarding the Reasonable Charge Update for 2003 for Splints and Casts

B-02-090

•

Implementation of the National Council for Prescription Drug Programs (NCPDP) Telecommunications Standard Version 5.1 and the Equivalent Batch Standard Version 1.1 for Retail Pharmacy Drug Transactions—CORRECTION

B-02-091

•

Provider Education Article: Requirements for Payment of Medicare Claims for Foot and Nail Care Services

B-02-092

•

Electromagnetic Stimulation

Program Memoranda

Intermediaries/Carriers

(CMS Pub. 60A/B)

(Superintendent of Documents No. HE 22.8/6-5)

AB-02-134

•

Questions and Answers Related to Implementation of National Coverage Determinations for Clinical Diagnostic Laboratory Services

AB-02-135

•

System Networking Electronic Correspondence Referral System 1.3 User and Installation Guides for Testing and Production

AB-02-136

•

Reasonable Charge Update for 2003 for Splints, Casts, Dialysis Supplies, Dialysis Equipment, Therapeutic Shoes, and Certain Intraocular Lenses

AB-02-137

•

Annual Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement

AB-02-138

•

Instructions for Fiscal Intermediary Standard System and Multi-Carrier System Healthcare Integrated General Ledger Accounting System Changes

AB-02-139

•

Additional Guidance for Applying the Medicare Self-Administered Drug Exclusion

AB-02-140

•

Data Center Testing and Production—Electronic Correspondence Referral System User Manual 5.1 and Quick Reference Guide Replacement

AB-02-141

•

Charging Fees to Providers for Medicare Education and Training Activities-Program Management

AB-02-142

•

Remittance Advice Coding Update

AB-02-143

•

Provider Education Article: Psychotropic Drug Use in Skilled Nursing Facilities

AB-02-144

•

Virginia Cardiac Surgery Initiative Demonstration

AB-02-145

•

Electronic Patient Records Via Non-Internet Means

AB-02-146

•

Revision to the Healthcare Provider Taxonomy Codes Crosswalk

AB-02-147

•

Promoting Influenza Vaccinations

AB-02-148

•

Remittance Advice Message for Ambulance Services

AB-02-149

•

Update to the Mammography Quality Standard Act File Record Layout for the Food and Drug Administration Certified Digital Mammography Centers

AB-02-150

•

Payment of Physician and Nonphysician Services for Certain Indian Providers

AB-02-151

•

Clarification Regarding Non-physician Practitioners Billing on Behalf of a Diabetes Outpatient Self-Management Training Services Program and the Common Working File Edits for Diabetes Outpatient Self-Management Training Services & Medical Nutrition Therapy. (

Note:

APASS has received a waiver for this Change Request

AB-02-152

•

Fee Schedule Update for 2003 for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

AB-02-153

•

Claims Processing Instructions for the Medicare Disease Management Demonstration

AB-02-154

•

New Waived Tests—September 27, 2002

AB-02-155

•

Beneficiary Notification of Denials Based on Local Medical Review Policy

AB-02-156

•

Coverage and Billing for Neuromuscular Electrical Stimulation

AB-02-157

•

Codes Billable by Skilled Nursing Facilities and Suppliers for Skilled Nursing Facility Residents—Notice of New File Available via CMS Mainframe Telecommunication System

AB-02-158

•

Common Working File, Fiscal Intermediary, and Carrier Edits and Policy Clarification for Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes

AB-02-159

•

Medicare Deductible and Premium Rates for Calendar Year 2003

AB-02-160

•

Medicare Telehealth Update

AB-02-161

•

Coverage and Billing Requirements for Electrical Stimulation for the Treatment of Wounds

AB-02-162

•

Deported Medicare Beneficiaries

AB-02-163

•

2003 Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Method

AB-02-164

•

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-02-165

•

Levocarnitine for Use in the Treatment of Carnitine Deficiency in End Stage Renal Disease Patients

AB-02-166

•

Editing of the Healthcare Provider Taxonomy Codes and Use of the Healthcare Provider Taxonomy Codes Crosswalk

AB-02-167

•

Notice of Interest Rate for Medicare Overpayments and Underpayments

AB-02-168

•

Advance Beneficiary Notice and Durable Medical Equipment Prosthetics, Orthotics & Supplies Refund Requirements—Corrections to PM AB-02-114

AB-02-169

•

Notice Requirement Related to Local Medical Review Policies

AB-02-170

•

File Descriptions and Instructions for Retrieving the 2003 Ambulatory Surgical Center Healthcare Common Procedure Code Additions and Deletions

AB-02-171

•

X12N Health Care Eligibility Benefit Inquiry/Response (270/271) Transaction Security and Connectivity Instructions

AB-02-172

•

Next Generation Desktop Data Center Connectivity—Security Information Clarification to Change Request 2079 (AB-02-073) Dated May 16, 2002

AB-02-173

•

Ambulance Fee Schedule Updates for 2003

AB-02-174

•

Single Drug Pricer

AB-02-175

•

Revisions to Common Working File Edits for Skilled Nursing Facility Consolidated Billing to Permit Payment for Certain Diagnostic Services Furnished to Beneficiaries Receiving Treatment for End Stage Renal Disease at an Independent or Provider-Based Dialysis Facility

AB-02-176

•

Prior Approval Requirement for Data Center and Front End Movement

AB-02-177

•

Independent Laboratory Billing for the Technical Component of Physician Pathology Services to Hospital Patients

AB-02-178

•

Clarification of the Comprehensive Error Rate Testing Program Contractor Resolution Process

AB-02-179

•

Complaint Screening

AB-02-180

•

Coverage and Billing for Home Prothrombin Time International Normalized Ratio Monitoring for Anticoagulation Management

AB-02-181

•

Medicare Physician Fee Schedule Update and the 2003 Participation Enrollment Process

AB-03-182

•

Coverage and Billing of Sacral Nerve Stimulation

AB-02-183

•

Coverage of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Wounds of the Lower Extremities

AB-02-184

•

Provider Notification of Denials Based on Local Medical Review Policy

AB-02-185

•

Deletion of Q Codes and Reactivation of CPT Codes for Hepatitis B Vaccine

Provider Reimbursement Manual—Part 1

(CMS Pub. 15-1)

Superintendent of Documents No. HE 22.8/4

423

•

Regional Medicare Swing-Bed Rates

Hospital Manual

(CMS Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

791

•

Billing for Mammography Screening

Diagnostic Mammography

Diagnostic and Screening Mammograms Performed with New Technologies

792

•

Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines

793

•

Payment for Services Furnished by a Critical Access Hospital

794

•

Payment for Services Furnished by a Critical Access Hospital

795

•

Heart Transplants

Skilled Nursing Facility Manual

(CMS—Pub. 12)

Superintendent of Documents No. HE 22. 8/3

375

•

Coverage and Patient Classification

Coverage Issues Manual

(CMS—Pub. 6)

Superintendent of Documents No. HE 22. 8/14

160

•

Neuromuscular Electrical Stimulation for Use by Spinal Cord Injured Patients for Walking

161

•

Electrical Stimulation for the Treatment of Wounds

Durable Medical Equipment—Reference List

162

•

Photosensitive Drugs

Levocarnitine for Use in the Treatment of Carnitine Deficiency in End Stage Renal Disease Patients

163

•

Home Blood Glucose Monitors

164

•

Hyperbaric Oxygen Therapy

165

•

Heart Transplants.

Financial Management

(CMS—Pub. 100-6)

•

Bankruptcy

Glossary of Acronyms

Basic Bankruptcy Terms and Definitions

Bankruptcy is Litigation

Types of Bankruptcies

Filing Bankruptcy Draws a Line in the Sand

Bankruptcy Affects Nearly All Medicare Operations

Recoupment and Set-off Time is of the Essence

Definitions

Contractor's Establishment of Relationships to Ensure Effective Actions Regarding Providers in Bankruptcy

Contractor Staff Must Establish Relationships to Ensure That the Regional Office and Regional Counsel Receive Prompt Notice of Provider Bankruptcies, So That Medicare Can Take Quick Action Contractors Must Recognize and Advise Regional Office Staff About Potential Provider Bankruptcies

Contractor Staff Will Establish a Relationship With the Regional Office That has Jurisdiction Over the Bankruptcy Regional Office Jurisdiction Generally Parallels the Bankruptcy Court Where Case is Filed

Contractor and Regional Office Bankruptcy Point of Contact Staff Member

Actions to Take When a Provider Files for Bankruptcy

Establish Effective Lines of Communication With Partners

Respond to Regional Office Requests for Information

Immediate Contractor Directives From the Regional Office

Tracking Debts/Contract Officer Communications

Chain Bankruptcies

Chain Providers

Single Providers Serviced by a National Contractor

Affirmative Recovery Actions

Working With the Regional Office and Regional Counsel's Office

Assumption of the Medicare Provider Agreement

Settlement Agreements or Stipulations

Recoupment

Administrative Freeze/Set-off

Preparing and Filing Proof of Claim

Closure of Bankruptcy Cases and Treatment of Overpayment Reporting

Systems at End of Bankruptcy

Closing the Bankruptcy Case

Debt Located at the Debt Collection Center or Department of the Treasury

Managing Bankruptcy Debt at the Contractor Location

Peer Review Organization

(CMS—Pub. 100-10)

Superintendent of Documents No. HE 22.8/8-15

•

Citations and Authority

Identification of Potential Violations

Meeting With a Practitioner or Other Person

Quality Improvement Organization Finding of a Violation

Quality Improvement Organization Action on Final Finding of a Violation

Quality Improvement Organization Report to the Office of Inspector General

Imposition and Notification of Sanctions

Effect of an Exclusion Sanction on Medicare Payment and Services

Reinstatement After Exclusion

Appeal Rights of the Excluded Practitioner or Other Person

End Stage Renal Disease Network

(CMS—Pub. 100-14)

•

Authority

Network's Role Prior to Initiating Sanction Recommendation

Project Officer Role in Sanction Procedures

Duration and Removal of Alternative Sanction

Definitions for the End Stage Renal Disease Complaint and Grievance Process

End Stage Renal Disease Complaints and Grievance

Role of Network in Handling a Complaint/Grievance

End Stage Renal Disease Complaints and Grievance Process

Facility Awareness of the Complaint/Grievance Process

Use of Facility Complaint/Grievance Process

Determination of Your Involvement

Receiving a Complaint/Grievance

Request of Grievance in Writing

Referring Complaints and Grievances

Written Acknowledgement of Grievances

Investigation of Complaints and Grievances

Life-Threatening Situations

Challenging Patient Situations

Advocating for Patient Rights

Addressing a Complaint or Grievance

Follow-up of a Grievance

Conclusion of a Grievance Investigation

Report and Letter to the Grievant

Potential Outcomes of Complaint/Grievance Process

Improvement Plans

Content of Improvement Plans

Time Periods for Review and Acceptance/Rejection of Improvement Plans

Improvement Plans Tracking System

Conclusion of Improvement Plans

Non-Compliance With Improvement Plans

Confidentiality and Disclosure of Information

Identity of Complainant/Grievant

Identity of Practitioner

Identity of Facility

Personal Representative

Conflict of Interest

End Stage Renal Disease Network Complaint Process

End Stage Renal Disease Grievance Process

End Stage Renal Disease Inquiry Process

Time Table for Complaints and Grievances

Model Response Letter of Acknowledgement of a Written Complaint/Grievance

Consent to Disclose Identity—Model Form

Designation of a Representative—Model Form

Final Response to Grievant—Model Letter

Addendum IV—Regulation Documents Published in the Federal Register

[October 2002 through December 2002]

Publication date

FR Vol. 67 page

CFR part(s)

File code *

Regulation title

10/01/2002

61496

42 CFR 413

Principles of Reasonable Cost Reimbursement; Payment for End-Stage Renal Disease Services; Prospectively Determined Payment Rates for Skilled Nursing Facilities: OFR Correction.

10/01/2002

61496

42 CFR 460

CMS-1201-IFC

Medicare and Medicaid Programs; Programs of All-inclusive Care for the Elderly (PACE); Program Revisions.

10/01/2002

61632

CMS-2160-N

State Children's Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2003.

10/02/2002

61805

42 CFR 482

CMS-3018-N

Medicare and Medicaid Programs; Hospital Conditions of Participation: Clarification of the Regulatory Flexibility Analysis for Patients' Rights.

10/02/2002

61808

42 CFR 482, 483, 484

CMS-3160-FC

Medicare and Medicaid Programs; Conditions of Participation: Immunization Standards for Hospitals, Long-Term Care Facilities, and Home Health Agencies.

10/02/2002

61956

42 CFR 457

CMS-2127-F

State Children's Health Insurance Program; Eligibility for Prenatal Care and Other Health Services for Unborn Children.

10/07/2002

62478

CMS-4050-NR

Medicare Program; Changes in Medicare Appeals Procedures Based on Section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000.

10/11/2002

63434

CMS-3109-N

Medicare Program; Town Hall Meeting on the Hospital “1-Hour” Rule Related to the Use of Restraint and Seclusion.

10/16/2002

63966

CMS-1201-IFC

Medicare and Medicaid Programs; Programs of All-inclusive Care for the Elderly (PACE); Program Revisions: OFR Correction.

10/21/2002

64641

CMS-8013-N

Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 2003.

10/21/2002

64643

CMS-8014-N

Medicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1, 2003.

10/21/2002

64649

CMS-8015-N

Medicare Program; Part A Premiums for 2003 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement.

10/25/2002

65504

42 CFR 431 and 438

CMS-2104-F2

Medicaid Program; Medicaid Managed Care: New Provisions Correcting Amendment.

10/25/2002

65582

CMS-2087-FN

Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2001.

10/25/2002

65585

CMS-2159-N

Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Approval of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as an Accrediting Organization.

10/25/2002

65588

CMS-4038-N

Medicare Program; Meeting of the Advisory Panel on Medicare Education—November 19, 2002.

10/25/2002

65672

42 CFR 409, 417, 422

CMS-4041-P

Medicare Program; Modifications to Managed Care Rules.

11/01/2002

66642

CMS-2141-FN

Medicare and Medicaid Programs; Approval of the American Osteopathic Association for Deeming Authority for Ambulatory Surgical Centers.

11/01/2002

66718

42 CFR 405 and 419

CMS-1206-FC and CMS-1179-F

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.

11/05/2002

67318

42 CFR 410 and 414

CMS-1204-N

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003, Notice of Delay of Final Rule.

11/15/2002

69146

42 CFR 405 and 419

CMS-1206-CN

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.

11/15/2002

69182

42 CFR 405

CMS-4004-P

Medicare Program; Changes to the Medicare Claims Appeal Procedures.

11/22/2002

70322

42 CFR 411

CMS-1809-F2

Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date.

11/22/2002

70358

42 CFR 412, 413, 476, 484

CMS-3055-P

Medicare Program; Photocopying Reimbursement Methodology.

11/22/2002

70363

42 CFR 418

CMS-1022-P

Medicare Program; Hospice Care Amendments.

11/22/2002

70373

42 CFR 482

CMS-1224-P

Medicare Program; Nondiscrimination in Posthospital Referral to Home Health Agencies and Other Entities.

11/22/2002

70435

CMS-1241-NC

Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waivers For Organ Procurement Service Areas.

11/22/2002

70437

CMS-2154-FN

Medicare and Medicaid Programs; Application by the Joint Commission on Accreditation of Healthcare Organizations for Continued Deeming Authority for Ambulatory Surgical Centers.

11/22/2002

70439

CMS-2155-FN

Medicare and Medicaid Programs; Approval of Application for Deeming Authority for Ambulatory Surgical Centers by the Accreditation Association for Ambulatory Health Care.

11/22/2002

70442

CMS-1220-N

Medicare Program; Fee Schedule for Payment of Ambulance Services' Update for CY 2003.

11/22/2002

70444

CMS-1217-N

Medicare Program; December 16, 2002, Meeting of the Practicing Physicians Advisory Council.

11/22/2002

CMS-6012-N3

Medicare Program; Establishment of the Negotiated Rulemaking Committee on Special Payment Provisions and Requirements For Prosthetics and Certain Custom-Fabricated Orthotics: January 6-7 and February 10-11, 2003 Meetings.

12/13/2002

76684

42 CFR 405

CMS-1908-IFC

Medicare Program; Application of Inherent Reasonableness to All Medicare Part B Services (Other Than Physician Services).

12/27/2002

79107

CMS-1231-N

Medicare Program; Re-Chartering of the Advisory Panel on Ambulatory Payment Classification Groups and Notice of Meeting of the Advisory Panel—January 21, 22, and 23, 2003.

12/27/2002

79109

CMS-3104-N

Medicare Program; Renewal and Amendment of the Charter of the Medicare Coverage Advisory Committee (MCAC).

12/27/2003

79109

CMS-9015-N

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

12/27/2003

79122

CMS-4055-N

Medicare Program; National Medicare+Choice Risk Adjustment Public Meeting—February 3, 2003.

12/27/2002

79123

CMS-1202-CN

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Correction Notice.

12/27/2002

79124

CMS-3105-N

Medicare Program; Meeting of the Medicare Coverage Advisory Committee—February 12, 2003.

12/27/2002

79125

CMS-1234-N

Medicare Program; February 10, 2003, Meeting of the Practicing Physicians Advisory Council.

12/31/2002

79966

42 CFR 410, 414, 485

CMS-1204-FC

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 and Inclusion of Registered Nurses in the Personnel Provision of the Critical Access Hospital Emergency Services Requirement for Frontier Areas and Remote Locations.

Addendum V—National Coverage Determinations [October 2002 through December 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 an 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 a 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 Notices

[Coverage Issues Manual—CMS Pub. 06]

Section

Title

Effective date

35-10

Hyperbaric Oxygen Therapy

April 1, 2003.

35-87

Heart Transplants

April 1, 2003.

60-11

Home Blood Glucose Monitors

not applicable.

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. Category A refers to experimental/investigational device exemptions, and Category B refers to nonexperimental/investigational device exemptions. 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) for the third quarter, July through September 2002. (We inadvertently failed to include this information in our December 27, 2002, quarterly issuances notice).

Investigational Device Exemption Numbers, 3rd Quarter 2002

IDE