# Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July 2003 Through September 2003

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A03-30756

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** December 24, 2003
- **Citation:** 68 FR 74590

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9019-N]
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July 2003 Through September 2003

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 2003 through September 2003, relating to the Medicare and Medicaid programs. This notice 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. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the
Federal Register
at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

FOR FURTHER INFORMATION CONTACT:

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

Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.

Questions concerning national coverage determinations in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.

Questions concerning 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, or you can call (410) 786-4633.

Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Dawn Willinghan, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6141.

Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-12-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954.

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) Furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the
Federal Register
. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda,

substantive and interpretive regulations, national coverage determinations (NCDs), and Food and Drug Administration (FDA)-approved investigational device exemptions (IDEs) published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare National Coverage Determination Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634).

To aid the reader, we have organized and divided this current listing into six addenda:

• Addendum I lists the publication dates of the most recent quarterly listings of program issuances.

• Addendum II identifies previous
Federal Register
documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.

• Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.

• Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the
Federal Register
during the quarter covered by this notice. For each item, we list the—

• Date published;

•
Federal Register
citation;

• Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);

• Agency file code number; and

• Title of the regulation.

• Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.

• Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.

• Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, Attn: New Orders, PO 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.gpoaccess.gov/fr/index.html
, by using local WAIS client software, or by telnet to
swais.gpoaccess.gov
, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

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 Hospice Manual, (CMS Pub. 21) transmittal entitled “Payment of Amounts Owed Medicare,” use the Superintendent of Documents No. HE 22.8/18 and the transmittal number 69.

(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 2, 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.

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)

March 28, 2003 (68 FR 15196)

June 27, 2003 (68 FR 38359)

September 26, 2003 (69 FR 55618)

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

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

Addendum III.—Medicare and Medicaid Manual Instructions
[July 2003 through September 2003]

Transmittal No.

Manual/Subject/Publication No.

Intermediary Manual

Part 3—Audits, Reimbursement Program Administration

(CMS-Pub. 13-3)

(Superintendent of Documents No. HE 22.8/6)

1892
•
Frequency of Billing

Provider Education

1893
•
Release Software

1894
•
Review of Form CMS-1450 (previously Form HCFA-1450) for Inpatient and

Outpatient Bills

1895
•
Diabetes Outpatient Self-Management Training Services

1896
•
Mammography Screening

Diagnostic Mammography

Diagnostic and Screening Mammography Performed With New Technologies

Mammography Billing Charts for Billing for Computer Aided Detection Devices

Common Working File Application of Age and Frequency Edits

Hospital Outpatient Partial Hospitalization Services

1897
•
Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End-Stage Renal Disease Who Are Covered by Group Health Plans

Definitions

Retroactive Implementation

Processing Claims

Determining the 30-Month Coordination Period During Which Medicare May Be Secondary Payer

Effect of Dual Entitlement

Subsequent Periods of End-Stage Renal Disease Eligibility or Entitlement

Amount of Secondary Medicare Payments Where Group Health Payments in Part for Items and Services

Limitation on Right of Provider or Facility to Charge a Beneficiary

Responsibility of Provider/Providers of Service and Renal Dialysis Facilities

Action When Group Health Payments Erroneously Pay Primary Benefits

Referral to Regional Offices of Cases Involving Taking Into Account Medicare Eligibility or Entitlement and Benefit Differentiation During Coordination Period

Claimant's Right To Take Legal Action Against a Group Health Plan

Medical Services Furnished to End-Stage Renal Disease Beneficiaries by Source Outside Group Health Plan Managed Care Plan

Limitations on Payment for Services to Aged Beneficiaries Who are Covered by a Group Health Plan on the Basis of Current Employment Status

Definitions

Individuals Subject to Limitation on Payment, General

Individuals Not Subject to Limitation on Payment, General

Identification of Cases by Providers of Services

Identification of Cases and Action Where There Is Indication of Possible Group Health Plan Coverage

Action by Provider Where Medicare Is Secondary to Group Health Plan

Limitation on Right of Provider or Facility to Charge a Beneficiary

Employer Plan Denies Claim for Primary Benefit

Referral of Cases to Regional Offices

Recovery of Mistaken Primary Medicare Payments

Advice to Providers, Physicians, and Beneficiaries

Mistaken Group Health Plan Primary Payments

Claimant's Right to Take Legal Action Against a Group Health Plan

Special Rules for Services Furnished by Source Outside Group Health Plan

Managed Care Health Plan

Medicare as Secondary Payer for Disabled Individuals

1898
•
Payment for Services Furnished by a Critical Access Hospital

Carriers Manual

Part 3—Program Administration

(CMS Pub. 14-3) (Superintendent of Documents No. HE 22.8/7)

1808
•
Mandatory Assignment and Participation Program

Participation Program

Limiting Charge

1809
•
Durable Medical Equipment Regional Carriers—Billing Procedures Related to Advance Beneficiary Notice Upgrades

Providing Upgrades of Durable Medical Equipment Prosthetic, Orthotics, and Supplies Without Any Extra Charge

1810
•
Payment for Physician Services Furnished to Dialysis Inpatients

Dialysis Services (Codes 90935-90999)

1811
•
Release Software

Contractor Testing Requirements

1812
•
Definitions of Lines 1 through 115

Checking Reports

Exhibits

1813
•
Data Element Requirements

Payment to Physician for Purchased Diagnostic Tests

Area Carriers—Physician's Services

Payment Jurisdiction for Services Paid Under the Physician Fee Schedule and Anesthesia Services

Claims Processing Instructions for Payment Jurisdiction for Claims Received On or After April 1, 2004

Payment Jurisdiction for Purchased Services

Jurisdiction for Shipboard Services

Exceptions to Jurisdictional Payment

Exhibit 10

Items 14-33 Physician or Supplier Information

1814
•
Screening Mammography Examinations

Identifying a Screening Mammography Claim and a Diagnostic Mammography Claim

Adjudicating the Claim

Diagnostic and Screening Mammograms Performed With New Technologies

1815
•
Repairs, Maintenance, Replacement, and Delivery

1816
•
Correct Coding Initiative

1817
•
Medicare Secondary Payment General Provisions

Third Party Payer Pays Charges in Full

Physician, Supplier, or Beneficiary Bills Medicare for Primary Benefits

Multiple Insurers

Third Party Payer Pays Primary Benefits When Not Required

Right of Physician or Supplier to Charge Beneficiary

General

Definitions

Current Employment Status

Employer-Sponsored Managed Care Health Plan

Nonconforming Group Health Plan

Recovery of Mistaken Primary Medicare Payments

Advice to Physicians/Suppliers and Beneficiaries

Mistaken Group Health Plan Primary Payments

Claimant's Right to Take Legal Action Against a Group Health Plan

Special Rules for Services Furnished by Source Outside Group Health Plan

Managed Care Health Plan

Medicare Secondary Payer Provisions for Working Aged Individuals

Individual Not Subject to Medicare Secondary Payer Provision

Exception for Small Employers in Multi-Employer and Multiple Employer Group Health Plan

Dually Entitled Individuals

General

Individuals Not Subject to Medicare Secondary Payer Provision

Items and Services Furnished On or After January 1, 1987 and Before August 10, 1993 (Date of Enactment of Omnibus Budget Reconciliation Act of 1993)

1818
•
Filing the Request for Payment

1819
•
Special Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

1820
•
Medicare Physician Fee Schedule Database 2004 File Layout

Maintenance Process for the Medicare Physician Fee Schedule Database

Carriers Manual

Part 4—Professional Relations

(CMS Pub. 14-4)

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

28
•
Provider of Services or Supplier Information

Program Memorandum Intermediaries

(CMS Pub. 60A)

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

A-03-057
•
Medicare Program-Update to the Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice for Fiscal Year 2004

A-03-058
•
Change in Methodology for Determining Payment for Outliers Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment System

A-03-059
•
Addition of Patient Status Code 43, Deletion of Patient Status Codes 71 and 72, and Information on New Patient Status Code 65

A-03-060
•
Medicare Program—Update to the Prospective Payment System for Home Health Agencies for Fiscal Year 2004

A-03-061
•
Tentative Settlement Requirements for Cost Reports from Home Health Agencies and Skilled Nursing Facilities That Have No Reimbursement Impact

A-03-062
•
Department of Veterans Affairs Claims Adjudication Services Project System Changes Needed

A-03-063
•
Installation of Version 30 of the Provider Statistical and Reimbursement Reporting System

A-03-064
•
X12N 837 Institutional Health Care Claim Companion Document

A-03-065
•
New Common Working File Edits to Ensure Accurate Coding and Payments for Discharge and/or Transfer Policies Under the Inpatient Prospective Payment System

A-03-066
•
Hospital Outpatient Prospective Payment System Implementation Instructions

A-03-067
•
The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2002 for Inpatient Prospective Payment System Hospitals

A-03-068
•
Informing Beneficiaries About Which Local Medical Review Policy and/or National Coverage Determination Is Associated With Their Claim Denial

A-03-069
•
October Outpatient Code Editor Specification Version (V4.3)

A-03-070
•
Inclusion of the State of New York in Demonstration for Settlement of Payments for Home Health Services to Dual Eligibles and Instructions for Processing Fiscal Year 2000 Claims Under the Demonstration. Regional Home Health Intermediaries Only.

A-03-071
•
Retroactive Correction of Provider Statistical and Reimbursement System Report Data Related to Mammography and Outpatient Therapy Services

A-03-072
•
Instructions for Provider Credit Balance Reporting Related Activities

A-03-073
•
Fiscal Year 2004 Inpatient Prospective Payment System, Long Term Care Hospital, and Other Billing Changes

A-03-074
•
Inpatient Rehabilitation Facility Annual Update: Prospective Payment System Pricer Changes for Fiscal Year 2004

A-03-075
•
Medicare Part A Skilled Nursing Facility Prospective Payment System Update

A-03-076
•
October 2003 Update of the Hospital Outpatient Prospective Payment System

A-03-077
•
October Medicare Outpatient Code Editor Specification Version 19.0 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System

A-03-078
•
Reimbursement for Automated Multi-Channel Chemistry Tests for End-Stage Renal Disease Beneficiaries

A-03-079
•
Installation of Version 31 of the Provider Statistical and Reimbursement Reporting System

A-03-080
•
End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Test

A-03-081
•
Conflicting Policies With Provider Reimbursement Manual 15-1, Section 2771

A-03-082
•
Clarification for Billing Under the 2300 Provider Number by Hospital-Based Renal Dialysis Facilities

Program Memorandum

Carriers

(CMS Pub. 60B)

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

B-03-050
•
Multiple Primary Payers on Part B Claims-Revision to Change Request 2050

B-03-051
•
Therapy Modifier Bypass for Ambulance Claims

B-03-052
•
Addition of Temporary “Q” Codes for Drugs Used in Infusion Pumps

B-03-053
•
Healthcare Provider Taxonomy Codes Crosswalk

B-03-054
•
Establishing and Maintaining Provider and Supplier Enrollment Data in Provider kEnrollment, Chain and Ownership System as Needed for Use By the Railroad Medicare Carrier to Pay Claims

B-03-055
•
Common Working File crossover Editing for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Claims During an Inpatient Stay

B-03-056
•
Durable Medical Equipment Regional Carriers—Additional Instructions for Health Insurance Portability and Accountability Act Implementatyion on National Drug Codes and the National Council of Prescription Drug Programs

B-03-057
•
Additional Guidelines for Implementing the National Council for Prescription Drug Program Format

B-03-058
•
Procedures for the Reconciliation of Total Funds Expended for Multi-Carriers Systems Medicare Contractors Used in the Preparation of Form CMS-1522, Monthly Contractor Financial Report

B-03-059
•
Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Single Drug Pricer

B-03-060
•
Expansion of Beneficiary History and Claims in Process Files in the Voucher Insurance Plan Viable Medicare System. Phase 2—Adjudication Claims in Process File Expansion

B-03-061
•
Durable Medical Equipment Regional Carriers National Council of Prescription of Drug Programs Crosswalk Requirements

B-03-062
•
Procedures for Non-Medicare Secondary Payer Overpayments With Original Balance Less than $10

B-03-063
•
Healthcare Provider Taxonomy Codes Crosswalk

B-03-064
•
Clarification—ICD-9 Coding

B-03-065
•
Changes to Code List for Therapy Services

B-03-066
•
Durable Medical Equipment Regional Carriers—Eliminate Combined Working File Edit for Cancer Diagnosis for National Drug Codes

B-03-067
•
National Council for Prescription Drug Programs Batch Transmittal Standard 1.1 Billing Request Companion Document

B-03-068
•
2004 Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers

B-03-069
•
Schedule for Completing the Calendar Year 2004 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-03-094
•
October 2003 Quarterly Updates for Skilled Nursing Facility Consolidated Billing

AB-03-095
•
Remittance Advice Remark and Reason Code Update

AB-03-096
•
Quarterly Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement

AB-03-097
•
Delay in Implementation of Outpatient Therapy Caps to September 1, 2003

AB-03-098
•
Medicare Summary Notice Implementation for Contractors Using Arkansas Part A Standard System and HCFA Part B Standard System

AB-03-099
•
Instructions for Fiscal Intermediary Standard System and Multi-Carriers System Healthcare Integrated General Ledger Accounting System Changes

AB-03-100
•
October Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule

AB-03-101
•
Clarification for CR 2562: Collection of Fee-for-Service Payments Made During Periods of Managed Care Enrollment

AB-03-102
•
Clarifications Regarding Coverage of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Wounds of the Lower Extremities

AB-03-103
•
Medicare Secondary Payer Debt Referral and Write-Off Closed Instructions

AB-03-104
•
Changes to the Laboratory National Coverage Determination Edit Software for October 1, 2003

AB-03-105
•
Harkin Grantees: Complaint Tracking System and Aggregate Reports

AB-03-106
•
Third Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule

AB-03-107
•
Federal Bankruptcy/State Insurer Liquidation Actions and Medicare Secondary Payer Debt

AB-03-108
•
Medicare Secondary Payer—(1) Use of Inter-Contractor Notices and the Common Working File for the Development of the Medicare Secondary Payer Conditional Payment Amount for Liability, No-Fault, Worker's Compensation, and Federal Tort Claims Act Cases; (2) Reminder Regarding Termination Updates to the Common Working File; (3) Reminder Regarding Savings Information to Non-Lead Contractors

AB-03-109
•
Discontinue Use of the Healthcare Integrity and Protection Data Bank for Provider Enrollment Only

AB-03-110
•
Adjustment to the Rural Mileage Payment Rate for Ground Ambulance Services

AB-03-111
•
Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing

AB-03-112
•
Transmittal AB-03-112 Has Been Rescinded

AB-03-113
•
Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System

AB-03-114
•
Claims Processing and Payment of Incomplete Screening Colonoscopies

AB-03-115
•
Payment Denial for Medicare Services Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States

AB-03-116
•
Update of Rates and Wage Index for Ambulatory Surgical Center Payment Effective October 1, 2003

AB-03-117
•
Contractor Guidance for Connection to the Medicare Data Communication Network for Real-time Eligibility Inquiries (270/271) Via a Route Other Than Insurance Value-Added Network Services

AB-03-118
•
Cease Further Work on the Eligibility File-Based Standard Trading Partner Agreement for the Purpose of Coordination of Benefits

AB-03-119
•
Final Update to the 2003 Medicare Physician Fee Schedule Database

AB-03-120
•
Medicare Secondary Payer—(1) Copy of Recovery Demand Packages Resulting From a Data Match or Non-Data Match Group Health Plan Recovery Action to Insurers/Third Party Administrators of Employers; (2) Documentation Required When an Insurer/Third Party Administrator Wishes to Resolve a Debt on Behalf of Its Client, an Employer Debtor

AB-03-121
•
Requirement to Cross Claims Over to Multiple Supplemental Insurers

AB-03-122
•
Notice of Interest Rate for Medicare Overpayments and Underpayments

AB-03-123
•
Scheduled Release for October Updates to Software Programs and Pricing/Coding Files

AB-03-124
•
Standard System Automation of the Notice of Change to Medicare Secondary Payer Auxiliary File Process

AB-03-125
•
Consolidation of Claims Cross-Over Process

AB-03-126
•
Change in Type of Service for L04080

AB-03-127
•
Payment for Fecal Leukocyte Examination Under Clinical Laboratory Improvement Amendments of 1988 Certificate for Provider-Performed Microscopy Procedures During Calendar Year 2003

AB-03-128
•
Clarification to Transmittal AB-03-044 (CR 2611), Addition of New Temporary “K” Codes

AB-03-129
•
Addition of Three New International Classifications of Diseases, Ninth Revision, Clinical Modification Diagnosis Codes To Be Effective as Part of the October 1, 2003, International Classification of Diseases, Clinical Update

AB-03-130
•
Levocarnitine for Use in the Treatment of Carnitine Deficiency in End-Stage Renal Disease Patients

AB-03-131
•
Update to Health Care Claims Status Category Codes and Health Care Claim Status Codes for Use With the Health Care Claim Status Request and Response ASCX12N 276/277

AB-03-132
•
Provider Education Article: Guidelines for Medicare Part B Laboratory Testing

AB-03-133
•
Managing Medicare Appeals Workloads in Fiscal Year 2004

AB-03-134
•
Modifier and Condition Code for Providers to Use When Billing for Implantable Automatic Defibrillators for Beneficiaries in Medicare+Choice Plan

AB-03-135
•
Darbepoetin Alfa (Trade Name Aranesp) and Epoetin Alfa (Trade Name Epogen) for Treatment of Anemia in End-Stage Renal Disease Patients on Dialysis

AB-03-136
•
Correction to Quarterly Update of Health Care Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement

AB-03-137
•
Update of Home Care Common Procedure Coding System Codes and Payment for Ambulatory Surgical Centers and File Names, Descriptions and Instructions for Retrieving the 2004 Ambulatory Surgical Center Home Health Care Common Procedure Coding System Additions, Deletions, and Master Listing

AB-03-138
•
Modification of Medicare Policy for Erythropoietin

AB-03-139
•
Appeals Quality Improvement and Data Analysis Activities

AB-03-140
•
2004 Healthcare Common Procedure Coding System Annual Update Reminder

AB-03-141
•
CMS Companion Document for the Accredited Standards Committee X12N276/277 Health Care Claim Status Request and Response

AB-03-142
•
The Coordination of Benefits Contractor Will Post the Lead Medicare Contractor in the Group Name Field on the Common Working File and Expansion of Lead Contractor Viewing in the Electronic Correspondence Referral System

AB-03-143
•
Implementation of Certain Initial Determination and Appeal Provisions Within Section 521 of the Medicare, Medicaid and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000

AB-03-144
•
Establishing a Uniform Process for the Preparation and Mailing of Case Files From the Contractor to the Office of Hearings and Appeals of the Social Security Administration

AB-03-145
•
Instructions for Contractors Other Than the Religious Nonmedical Health Care Institution Specialty Intermediary Regarding Claims For Beneficiaries With Religious Nonmedical Health Care Institution Elections

AB-03-146
•
Reminder Notice of the Implementation of the Ambulance Transition Schedule

AB-03-147
•
Core Elements and Required Statements for a Valid Privacy Authorization

State Operations Manual

(CMS Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

31
•
Regional Offices Assignment of Provider and Supplier Identification Number

Hospice Manual

(CMS Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

806
•
Hospital Manual, Credit Balance Reporting Requirements—General Provisions

Payment of Amounts Owed Medicare

Medicare Credit Balance Reporting Certification Page

807
•
Payment for Services Furnished by a Critical Access Hospital

Home Health Agency Manual

(CMS Pub. 11)

(Superintendent of Documents No. HE 33.8/5)

305
•
Diabetes Outpatient Self-Management Training

306
•
Home Health Agency Manual, Credit Balance Reporting Requirements—General Provisions

Completing the Centers for Medicare & Medicaid Services—838

Payment of Amounts Owed Medicare

Medicare Credit Balance Report Certification Page

Skilled Nursing Facility Manual

(CMS Pub. 12)

(Superintendent of Documents No. HE 22.8/3)

377
•
Credit Balance Reporting Requirements—General Provisions

Payment of Amounts Owed Medicare

Medicare Credit Balance Report Certification Page

Coverage Issues Manual

(CMS Pub. 6)

(Superintendent of Documents No. HE 22.8/14)

173
•
Implantable Automatic Defibrillators

Peer Review Organization (CMS Pub. 19)

(Superintendent of Documents No. 22.8/8-15)

91
•

Case Review and Health Care Quality Improvement Program—has been moved to Corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at
http://www.cms.hhs.gov/manuals.

92
•

Denials, Reconsiderations and Appeals—has been moved to corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organization Manual, which can be found at
http://www.cms.hhs.gov/manuals.

93
•

Agreements—has been moved to Corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organization Manual, which can be found at
http://www.cms.hhs.gov/manuals.

94
•

Confidentiality and Disclosure—has been moved to the Corresponding Internet-Only Manual, which can be found at
http://www.cms.hhs.gov/manuals.

95
•

Outreach Activities—has been moved to corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at
http://www.cms.hhs.gov/manuals.

96
•

Payment Error Prevention Program—has been moved to corresponding Internet-Only Manual chapter in Pub.100-10, Medicare Improvement Organizations Manual, which can be found at
http://www.cms.hhs.gov/manuals.

97
•

Beneficiary Complaint Review—has been moved to corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at
http://www.cms.hhs.gov/manuals.

98
•

Data Management—has been moved to corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at
http://www.cms.hhs.gov/manuals.

Hospice Manual

(CMS Pub. 21)

(Superintendent of Documents No. HE 22.8/18)

69
•
Hospice Manual, Credit Balance Reporting Requirements—General Provisions

Completing the Centers for Medicare & Medicaid Services—838

Payment of Amounts Owed Medicare

Medicare Credit Balance Report Certification Page

Outpatient Physical Therapy and Comprehensive

Outpatient Rehabilitation Facility Manual

(CMS Pub. 9)

(Superintendent of Documents No. HE 22. 8/9)

18
•
Outpatient Physical Therapy/Comprehensive Outpatient Rehabilitation

Facility/Community Mental Health/Clinic Manual, Credit Balance Reporting Requirements

General Provisions

Completing the Centers for Medicare & Medicaid Services—838

Payment of Amounts Owed Medicare

Medicare Credit Balance Reporting Certification Page

Rural Health Clinic Manual & Federally Qualified

Health Centers Manual

(CMS Pub. 27)

(Superintendent of Documents No. He 22.8/19:985)

39
•
Rural Health Clinic and Federally Qualified Health Center Manual, Credit Balance Reporting—General Provisions

Completing the CMS-838

Payment of Amounts Owed Medicare

Medicare Credit Balance Reporting Certification Page

Rural Dialysis Facility Manual

(Non-Hospital Operated)

CMS Pub. 29)

(Superintendent of Documents No. 22.8/13)

96
•
Renal Health Clinic Manual, Credit Balance Reporting Requirement—General Provisions

Completing the Centers for Medicare & Medicaid Services-838

Payment of Amounts Owed Medicare

Medicare Credit Balance Report Certification Page

Provider Reimbursement Manual

Part 2 Provider Cost Reporting Forms and Instructions

Chapter 11/Form CMS 22.8/4

(CMS Pub. 15-2-11)

5
•
Reimbursement Information

ESRD Network Organizations Manual

(CMS Pub. 81)

(Superintendent of Documents No. HE 22.9/4)

15
•
Background and Responsibilities

Administration

Confidentiality and Disclosure

Information Management

Quality Improvement

Community Information and Resource

Sanctions and End-Stage Renal Disease Grievances

Publication Policy

Information Collection

Medicare Claims Processing Manual

(CMS Pub. 100-04)

3
•
New Effective Data for CR2112 (Revisions to the Outpatient Prospective Payment System Pricer Software and Outpatient Code Editor for Blood Deductible and Technician)

Financial Management

(CMS Pub. 100-06)

19
•
Intermediary Claims Accounts Receivable

Medicare Program Integrity

(CMS Pub. 100-08)

44
•
When to Develop New/Revised Local Medical Review Policy

Coverage Provisions in Local Medical Review Policy

Contractor Medical Director

Local Medical Review Policy Development Process

Final Local Medical Review Policy Web Site Requirements

45
•
Focused Medical Review Activity Report

46
•
Prepayment Edits

47
•
Data Analysis

Centers for Medicare & Medicaid Services Mandated Edits

48
•
Written Orders Prior to Delivery

49
•
Denial Notices

50
•
Instructions for Processing Advance Determination of Medicare Coverage Request

51
•
Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System

Quality Improvement Organization

(CMS Pub. 100-10)

2
•
Introduction

Referrals

Quality Review

Diagnostic Related Group

Limitation on Liability Determinations

Third-Level Physician Review

Use of the Physician Reviewer Assessment Format

Review Setting

Requesting Medical Records/Reviewing Documentation

Providing Opportunity for Discussion

Adhering to Review Timeframes

Monitoring Hospitals' Physician Acknowledgement Statements

3
•
Introduction

Quality Improvement Project Process

Developing and Conducting Interventions

Documenting and Disseminating Results

Centers for Medicare & Medicaid Services Project Support and Guidance Activities

Related Activities Through Quality Improvement Organizations, Carrier, Intermediary, and End-Stage Renal Diseases Network Cooperation

4
•
Beneficiary Request for Review of Hospital-Issued Notice of Non-Coverage by a Quality Improvement Organization

5
•
Intermediary/Carrier Memorandum of Agreement Specifications

Introduction

Memorandum of Agreement With State Agencies Responsible for Licensing/Certification of Providers/Practitioners

6
•
Statutory and Regulatory Requirements

General Requirements

Confidential Information

Disclosure of Confidential Quality Improvement Organization Information to Officials and Agencies

Disclosure of Quality Improvement Organization Information for Research Purposes

Disclosure of Quality Improvement Organization Sanction Information

Re-disclosure of Quality Improvement Organization Information

7
•
Beneficiary Helpline Language

Beneficiary Complaints

Physician/Provider Meeting Activities

Quality Improvement Organization/Intermediary/Carriers Coordination Activities

Background

Confidentiality Requirements

Report Requirements

Distribution Requirements

Publications Policy

Definition

Requirements

Disagreements

Information Collection Policy

Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Requirement

Statutory and Regulatory Requirements—Office of Management & Budget

Centers for Medicare & Medicaid Services, Information Collection

Approval Process

Additional Consideration

8
•
Introduction

Review Responsibilities

Monitoring Hospital Payment Patterns and Developing

Collaborating With Provider and Practitioner Groups

Collaborating Efforts With Federal and State Agencies and Other Medicare Contractors

9
•
Scope of Review

Complaints That Do Not Meet Statutory Requirements

Referral

Review Process

Notice of Disclosure

Final Response to Complaints

Disclosure of Quality Review Information to Complaints

Corrective Actions

Coordination With Other Entities

Data Analysis and Reporting Requirements

10
•
Authority

Purpose of Quality Improvement Organization Review

Quality Improvement Organization Responsibilities

Centers for Medicare & Medicaid Services' Role

Health Care Quality Improvement Program

Hospital Payment Monitoring Program

End Stage Renal Disease

(CMS Pub. 100-14)

1
•
Forward

Purpose of the Network Manual

Statutes and Regulations

End-Stage Renal Disease Network Organization's Manual Revisions

Acronyms and Glossary

Purpose of End-Stage Renal Disease Network Organization

Requirements for End-Stage Renal Disease Network Organization

Responsibilities of End-Stage Renal Disease Network Organization

Health Care Quality Improvement Program

Goals

Network Organization's Role in Health Care Quality Improvement Program

2
•
Forward

Purpose of the Network Manual

Statutes and Regulations

Revision to the End-Stage Renal Disease Organizations Manual

Purpose of End-Stage Renal Disease Network Organization

Requirements for End-Stage Renal Disease Network Organizations

Responsibilities of End-Stage Renal Disease Network Organizations

Goals

Network Organization's Role in Health Care Quality Improvement Program

3
•
Organizational Structure

Establishing the Network Computer

Board of Directors

Other Committees

Network Staff

Required Administrative Reports/Activities

Quarterly Progress and Status Reports

Annual Report

Semi-Annual Report of Network Operating Costs

New End-Stage Renal Disease Patient Orientation Package Activities

Internal Quality Control Program

Internal Quality Control Program Requirements

Managed Care Manual (CMS Pub. 100-16)

26
•
Alternate Employer Group Enrollment Election

Optional Employer Group Medicare+Choice Enrollment Election

Request Submitted via Internet

Request Signature and Data

Effective Dates

Notice Requirements

Optional Employer Group Medicare+Choice Disenrollment Election

Medigap Guaranteed Issue Notification Requirements

General Rule

Effective Date

Researching and Acting on a Change of Address

Clarified the Notice Requirements for Out of Area Permanent

27
•
Noncontracted Provider Appeals

Storage of Appeal Case Files by the Independent Review Entity

Representative Filing on Behalf of the Enrollee

Storage of Hearing Files

28
•
Streamlined Marketing Review Process

Introduction

Marketing Review Process

Guidelines for Advertising Material

Guidelines for Advertising (Pre-Enrollment) Material

Guidelines for Beneficiary Notification Materials

Model Annual Notice of Change

General Guidance on Dual Eligibility

Guideline for Outreach Program

Submission Requirements

Centers for Medicare & Medicaid Services' Review/Approval Process

Model Direct Mail Letter

Summary of Benefits for Medicare+Choice Organizations

Referral Programs

Allowable Actions for Medicare+Choice Organizations

Specific Guidance About the Use of Independent Insurance Agents

Answers to Frequently Asked Questions About Promotional Marketing of Multiple Lines of Business

29
•
Introduction

Quality Assessment and Performance Improvement Program

Administration of the Quality Assessment and Performance Improvement Program

Medicare+Choice Organizations Using Physician Incentive Plans

Health Information System

Quality Assessment and Performance Improvement

Centers for Medicare & Medicaid Services' Directed Special Projects

Reporting Time Frames

Communication Process

Quality Assessment and Performance Improvement

Process for Centers for Medicare & Medicaid Services' Multi-Year Quality Assessment and Performance Improvement Program Project Approvals

Evaluation of Quality Assessment and Performance Improvement Program Projects

The Medicare+Choice Deeming Program

Terminology

General Rule

Obligations of Deemed Medicare and Medicaid Organizations

Oversight of Accrediting Organizations

Application Requirements

Reporting Requirements

Informal Hearing Procedures

30
•
Reasonable Cost-Based Payments—General

Reasonable Cost Payments

Bill Processing

Principles of Payments

Budget and Enrollment Forecast

Interim Per Capita Rate

Interim Payment for Health Care Prepayment Plans

Electronic Transfer of Funds

Payment Report

Interim and Final Cost and Enrollment Report

Adjustment of Payments

Final Cost Report

Final Settlement Process for Medicare Health Care Prepayment Plans

Final Settlement Payment for Medicare Health Care Prepayment Plans

Recovery of Overpayment

Interest Charges for Medicare Overpayments/Underpayments

The Basic Rules

Definition of Final Determination

Rate of Interest

Accrual of Interest

Waiver of Interest

Rules Applicable to Partial Payments

Exception to Applicability

Nonallowable Interest Cost

Centers for Medicare & Medicaid Services' General Payment Principles

Medicare Payments to Health Care Prepayment Plans

Prudent Buyer Principle

Allowable Costs

Costs Not Reimbursable Directly to the Health Care Prepayment Plans

Deductible and Coinsurance

Hospice Care Costs

Medicare as Secondary Payer

31
•
Overview of Enrollment and Payment Process

Purpose of the Chapter

Medicare+Choice Organization Data Processing Responsibilities

Centers for Medicare & Medicaid Services' Group Health Plan System

Enrollment/Disenrollment Requirements and Effective Dates

General

Enrollments

Cost-Based Medicare+Choice Organizations Only

Medicare+Choice Organizations Only

Disenrollments

Cost-Based Medicare+Choice Organizations Only

Medicare+Choice Organizations Only

Cost-Based Medicare+Choice Organizations Only—Employer Group Health Plan

Retroactive Enrollment

Medicare Membership Information

The Centers for Medicare & Medicaid Services' Medicare+Choice

Organizations Only Interface Submitting Medicare Membership

Information to Centers for Medicare & Medicaid Services

Submission of Enrollment/Disenrollment Transaction Records

Submission of Correction Transaction Records

Health Insurance Claim Number

Transaction Type Code and the Prior Commercial Indicator

Transaction Type Codes

Prior Commercial Months Field

Special Status Beneficiaries—Medicare+Choice Organizations

Special Status Beneficiaries

Special Status—Hospice

Special Status—End-Stage Renal Disease

Special Status—Institutionalized

Special Status—Medicaid/Medical Assistance Only

Special Status—Working Aged

When to Submit “Special Status” Information (Medicare+Choice Organizations Only)

Other Medicare Membership Information

Risk Adjustment Payment

Bonus Payment

Extra Payment in Recognition of Quality Congestive Heart Failure

Outpatient Care

Benefit Stabilization Fund

Electronic Submission of Membership Records to Centers for Medicare & Medicaid Services

Timeliness Requirements

Record Submission Schedule

Sending the Transaction File to Centers for Medicare & Medicaid Services

Electronic Data Transfer

Centers for Medicare & Medicaid Services' Data Center Access

Data Processing Vendor

Receiving Medicare Membership Information Form Centers for Medicare & Medicaid Services

General

Centers for Medicare & Medicaid Services' Transaction Reply/Monthly Activity Report

Transaction Reply Field Information

Plan Payment Report

Demographic Report—Medicare+Choice Organizations Only

Medicare Fee-For-Service Bill Itemization and Summary Report

Monthly Membership Report

Bonus Payment Report

Working Aged Transaction Status Report

Retroactive Payment Adjustment Policy

Standard Operating Procedures for State and County Code Adjustments

Standard Operating Procedures for Processing of Institutional Adjustments

Standard Operating Procedures for Medicaid Retroactive Adjustments

Standard Operating Procedures for End-Stage Renal Disease Retroactive Adjustments

Processing of Working Aged Retroactive Adjustments

Standard Operating Procedures for Retroactive Adjustment Plan Elections

Centers for Medicare & Medicaid Services, Social Security Administration, and Customer Service Center Disenrollments

General

Medicare Customer Service Center Disenrollments

Centers for Medicare & Medicaid Services' Disenrollments

Coordination With the Medicare Fee-For-Services Program

Pro-Rate Deductible

Duplicate Payment Prevention by Cost-Based Medicare+Choice Organizations

Addendum IV—Regulation Documents Published in the
Federal Register
[July 2003 Through September 2003]

Publication date
FR Vol. 68 page No.
CFR parts affected
File code
Title of regulation

July 2, 2003
39764

CMS-1473-NC
Medicare Program; Home Health Prospective Payment System Rate Update for FY 2004.

July 15, 2003
41861

OFR Correction
Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes.

July 25, 2003
44091

CMS-3117-N
Medicare Program; Meeting of the Medicare Coverage Advisory Committee September 9, 2003.

July 25, 2003
44089

CMS-1260-N
Medicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 22, 2003.

July 25, 2003
44088

CMS-3124-WN
Medicare Program; Withdrawal of Medicare Coverage of Multiple-Seizure Electroconvulsive Therapy, Electrodiagnostic Sensory Nerve Conduction Threshold Testing, and Noncontact Normothermic Wound Therapy.

July 25, 2003
44000
42 CFR Part 424
CMS-1185-P
Medicare Program; Elimination of Statement of Intent Procedures for Filing Medicare Claims.

July 25, 2003
43998
42 CFR Part 406
CMS-4018-P
Medicare Program; Continuation of Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity.

July 25, 2003
43995
42 CFR Parts 405 and 411
CMS-6014-P
Medicare Program; Interest Calculation.

July 25, 2003
43940
42 CFR Parts 411 and 489
CMS-1475-FC
Medicare Program; Third Party Liability Insurance Regulations.

August 1, 2003
45674
42 CFR Part 412
CMS-1474-F
Medicare Program; Changes to the Inpatient Rehabilitation Facility Prospective Payment System and Fiscal Year 2004 Rates.

August 1, 2003
45346
42 CFR Parts 412 and 413
CMS-1470-F
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.

August 4, 2003
46036
42 CFR Parts 409, 411, 413, 440, 483, 488, and 489
CMS-1469-F
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.

August 11, 2003
47637
42 CFR Part 412
CMS-1470-F
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.

August 12, 2003
47966
42 CFR Parts 410 and 419
CMS-1471-P
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates.

August 15, 2003
49030
42 CFR Parts 410 and 414
CMS-1476-P
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004.

August 15, 2003
48805
42 CFR Part 424
CMS-0008-IFC
Medicare Program; Electronic Submission of Medicare Claims.

August 20, 2003
50428
42 CFR Part 405
CMS-1229-P
Medicare Program; Payment Reform for Part B Drugs.

August 22, 2003
50840
42 CFR Parts 409, 417, and 422
CMS-4041-F
Medicare Program; Modifications to Managed Care Rules.

August 22, 2003
50794

CMS-1236-N
Medicare Program; September 15 and 16, 2003, Meeting of the Practicing Physicians Advisory Council and Request for Nominations.

August 22, 2003
50793

CMS-4053-N
Medicare Program: Meeting of the Advisory Panel on Medicare Education—September 18, 2003.

August 22, 2003
50790

CMS-2136-FN
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2002.

August 22, 2003
50784

CMS-2166-N
State Children's Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2004.

August 22, 2003
50735
42 CFR Part 414
CMS-1167-P
Medicare Program; Payment for Respiratory Assist Devices With Bi-level Capability and a Back-up Rate.

August 22, 2003
50722

CMS-2226-CN
Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Correction.

August 22, 2003
50717
42 CFR Part 413
CMS-1199-F
Medicare Program; Electronic Submission of Cost Reports.

August 29, 2003
51912
42 CFR Part 447
CMS-2175-FC
Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program.

September 9, 2003
53266
42 CFR Part 412
CMS-1262-P
Medicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility.

September 9, 2003
53222
42 CFR Parts 413, 482, and 489
CMS-1063-F
Medicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions.

September 26, 2003
55634

CMS-3062-N
Medicare Program; Revised Process for Making Medicare National Coverage Determinations.

September 26, 2003
55618

CMS-9018-N
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April 2003 Through June 2003.

September 26, 2003
55616

CMS-2182-FN
Medicare and Medicaid Programs; Reapproval of the Community Health Accreditation Program (CHAP) for Deeming Authority for Hospices.

September 26, 2003
55566
42 CFR Parts 410 and 414
CMS-1476-CN
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004; Correction.

September 26, 2003
55528
42 CFR Parts 483 and 488
CMS-2131-F
Medicare and Medicaid Programs; Requirements for Paid Feeding Assistants in Long Term Care Facilities.

September 26, 2003
55527
42 CFR Part 447
CMS-2175-CN
Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction

September 29, 2003
55882
42 CFR Parts 409, 411, 413, 440, 483, 488, and 489
CMS-1469-CN
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction.

September 30, 2003
56478

CMS-1233-N
Medicare Program; Hospice Wage Index for Fiscal Year 2004.

September 30, 2003
56383

CMS-1473-NC OFR Correction
Medicare Program; Home Health Prospective Payment System Rate Update for FY 2004; Correction.

Addendum V—National Coverage Determinations [July 2003 Through September 2003]

A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at
http://cms.hhs.gov/coverage
.

National Coverage Decisions [July 2003 Through September 2003]

Coverage Issues Manual (CIM) (CMS Pub. 06)

CIM section
Title
Issue date
Effective date

35-85.1
Implantable Automatic
08/22/03
10/01/03

Defibrillators
09/22/03 (correction)
10/01/03

Program Memorandum (PM)

PM No.
Title
Issue date
Effective date

AB-03-104
Changes to the Laboratory NCD Edit Software For 10/03
07/25/03
10/01/03

Federal Register Publications

Title
Publication date
Effective date

CMS-3062-N—Revised Process for Making National Coverage Determinations
09/26/03
N/A

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 (FDA) assigns each device with an FDA-approved investigational device exemption (IDE) 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 second quarter, July through September 2003.

Investigational Device Exemption Numbers, 3rd Quarter 2003

IDE
Category

G020202
B

G020312
B

G020316
B

G030027
B

G030031
B

G030040
B

G030059
B

G030066
B

G030100
B

G030121
B

G030131
B

G030133
B

G030134
B

G030135
B

G030136
B

G030137
B

G030138
B

G030141
B

G030143
B

G030144
B

G030145
B

G030146
B

G030147
B

G030151
B

G030159
B

G030162
B

G030165
B

G030167
B

G030169
B

G030170
B

G030172
B

G030173
B

G030174
B

G030177
B

Addendum VII—Approval Numbers for Collections of Information

Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:

OMB control Nos.

Approved CFR sections in Title 42, Title 45, and Title 20 (
Note:
sections in Title 45 are preceded by “45 CFR,” and sections in Title 20 are preceded by “20 CFR”)

0938-0008
414.40, 424.32, 424.44

0938-0022
413.20, 413.24, 413.106

0938-0023
424.103

0938-0025
406.28, 407.27

0938-0027
486.100-486.110

0938-0033
405.807

0938-0034
405.821

0938-0035
407.40

0938-0037
413.20, 413.24

0938-0041
408.6

0938-0042
410.40, 424.124

0938-0045
405.711

0938-0046
405.2133

0938-0050
413.20, 413.24

0938-0062
431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5

0938-0065
485.701-485.729

0938-0074
491.1-491.11

0938-0080
406.7, 406.13

0938-0086
420.200-420.206, 455.100-455.106

0938-0101
430.30

0938-0102
413.20, 413.24

0938-0107
413.20, 413.24

0938-0146
431.800-431.865

0938-0147
431.800-431.865

0938-0151
493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489

0938-0155
405.2470

0938-0170
493.1269-493.1285

0938-0193
430.10-430.20, 440.167

0938-0202
413.17, 413.20

0938-0214
411.25, 489.2, 489.20

0938-0236
413.20, 413.24

0938-0242
416.44, 418.100, 482.41, 483.270, 483.470

0938-0245
407.10, 407.11

0938-0246
431.800-431.865

0938-0251
406.7

0938-0266
416.41, 416.47, 416.48, 416.83

0938-0267
410.65, 485.56, 485.58, 485.60, 485.64, 485.66

0938-0269
412.116, 412.632, 413.64, 413.350, 484.245

0938-0270
405.376

0938-0272
440.180, 441.300-441.305

0938-0273
485.701-485.729

0938-0279
424.5

0938-0287
447.31

0938-0296
413.170

0938-0300
431.800

0938-0301
413.20, 413.24

0938-0302
418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100

0938-0313
418.1-418.405

0938-0328
482.12, 482.22, 482.27, 482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66

0938-0334
491.9

0938-0338
486.104, 486.106, 486.110

0938-0354
441.60

0938-0355
484.10-484.52

0938-0357
409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21

0938-0358
412.20-412.30

0938-0359
412.40-412.52

0938-0360
405.2100-405.2184

0938-0365
484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52

0938-0372
414.330

0938-0378
482.60-482.62

0938-0379
442.30, 488.26

0938-0386
405.2100-405.2171

0938-0391
488.18, 488.26, 488.28

0938-0426
476.104, 476.105, 476.116, 476.134

0938-0429
447.53

0938-0443
473.18, 473.34, 473.36, 473.42

0938-0444
1004.40, 1004.50, 1004.60, 1004.70

0938-0445
412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78

0938-0447
405.2133

0938-0449
440.180, 441.300-441.310

0938-0454
424.20

0938-0456
412.105

0938-0463
413.20, 413.24

0938-0465
411.404, 411.406, 411.408

0938-0467
431.17, 431.306, 435.910, 435.920, 435.940-435.960

0938-0469
417.107, 417.478

0938-0470
417.143, 417.408

0938-0477
412.92

0938-0484
424.123

0938-0486
498.40-498.95

0938-0501
406.15

0938-0502
433.138

0938-0512
486.301-486.325

0938-0526
462.102, 462.103. 475.100, 475.106, 475.107

0938-0534
410.38, 424.5

0938-0544
493.1-493.2001

0938-0565
411.20-411.206

0938-0566
411.404, 411.406, 411.408

0938-0567
Part 498 Subparts D and E, and 20 CFR 404.933

0938-0573
412.230, 412.256

0938-0581
493.1-493.2001

0938-0599
493.1-493.2001

0938-0600
405.371, 405.378, 413.20

0938-0610
417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102

0938-0612
493.1-493.2001

0938-0618
433.68, 433.74, 447.272

0938-0653
493.1771, 493.1773, 493.1777

0938-0655
493.1840

0938-0657
405.2110, 405.2112

0938-0658
405.2110, 405.2112

0938-0667
482.12, 488.18, 489.20, 489.24

0938-0673
430.10

0938-0679
410.38

0938-0685
410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12

0938-0686
493.551-493.557

0938-0688
486.301-486.325

0938-0690
488.4-488.9, 488.201

0938-0691
412.106

0938-0692
466.78, 489.20, 489.27

0938-0700
417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103, 1003.106

0938-0701
422.152

0938-0702
45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180

0938-0703
45 CFR 148.120, 148.124, 148.126, and 148.128

0938-0714
411.370-411.389

0938-0717
424.57

0938-0721
410.33

0938-0722
422.370-422.378

0938-0723
421.300-421.318

0938-0730
405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24

0938-0732
417.126, 417.470

0938-0734
45 CFR 5b

0938-0739
413.337, 413.343, 424.32, 483.20

0938-0742
422.300-422.312

0938-0749
424.57

0938-0753
422.000-422.700

0938-0754
441.152

0938-0758
413.20, 413.24

0938-0760
Part 484 Subpart E, 484.55

0938-0761
484.11, 484.20

0938-0763
422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622

0938-0768
417.800-417.840

0938-0770
410.2

0938-0778
422.64, 422.111, 422.560-422.622

0938-0779
417.126, 417.470, 422.64, 422.210

0938-0781
411.404-411.406, 484.10

0938-0786
438.352, 438.360, 438.362, 438.364

0938-0787
406.28, 407.27

0938-0790
460.12, 460.22, 460.26, 460.30, 460.32, 460.52, 460.60, 460.70, 460.71, 460.72, 460.74, 460.80, 460.82, 460.98, 460.100, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.154, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210

0938-0792
491.3, 491.8, 491.11

0938-0798
413.24, 413.65, 419.42

0938-0802
419.43

0938-0810
482.45

0938-0819
45 CFR 146.121

0938-0823
420.410

0938-0824
440.10, 482.13

0938-0827
45 CFR 146.141

0938-0829
422.568

0938-0832
Part 489

0938-0833
483.350-483.376

0938-0841
431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180

0938-0842
412, 413

0938-0846
411.1, 411.350-411.357, 424.22

0938-0857
Part 419

0938-0860
Part 419

0938-0866
45 CFR Part 162

0938-0872
413.337, 483.20

0938-0873
422.152

0938-0874
45 CFR Parts 160 and 162

0938-0878
Part 422 Subparts F and G

0938-0883
45 CFR Parts 160 and 164

0938-0887
45 CFR 148.316, 148.318, 148.320

0938-0897
412.22, 412.533

[FR Doc. 03-30756 Filed 12-23-03; 8:45 am]
BILLING CODE 4120-01-P

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A03-30756. Public record. Not legal advice.