Document

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

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2003 through September 2003...

Department of Health and Human Services
Centers for Medicare & Medicaid Services
  1. [CMS-9019-N]

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, ( printed page 74591) 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:

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: https://cms.hhs.gov/​manuals/​default.asp.

B. Regulations and Notices

Regulations and notices are published in the daily Federal Register . Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.

The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is https://www.gpoaccess.gov/​fr/​index.html, by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

C. Rulings

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

D. CMS'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:

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

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

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

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the ( printed page 74592) 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
( printed page 74593)
    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
( printed page 74594)
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
( printed page 74595)
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
( printed page 74596)
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
( printed page 74597)
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 https://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 https://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 https://www.cms.hhs.gov/​manuals.
94 • Confidentiality and Disclosure—has been moved to the Corresponding Internet-Only Manual, which can be found at https://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 https://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 https://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 https://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 https://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
( printed page 74598)
Provider Reimbursement Manual
Part 2 Provider Cost Reporting Forms and Instructions
(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
( printed page 74599)
    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
( printed page 74600)
    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
( printed page 74601)
    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
( printed page 74602)
    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.
( printed page 74603)
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.
( printed page 74604)
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 https://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
( printed page 74605)
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
( printed page 74606)
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
( printed page 74607)
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

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

68 FR 74590

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July 2003 Through September 2003,” thefederalregister.org (December 24, 2003), https://thefederalregister.org/documents/03-30756/medicare-and-medicaid-programs-quarterly-listing-of-program-issuances-july-2003-through-september-2003.