03-30756. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July 2003 Through September 2003  

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    AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice.

    SUMMARY:

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

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    FOR FURTHER INFORMATION CONTACT:

    It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer 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.

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    SUPPLEMENTARY INFORMATION:

    I. Program Issuances

    The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of 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, Start Printed Page 74591substantive 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 Start Printed Page 74592FDL 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)

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    Dated: December 2, 2003.

    Jacquelyn Y. White,

    Director, Office of Strategic Operations and Regulatory Affairs.

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    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)
    1892Frequency of Billing
    Provider Education
    1893Release Software
    1894Review of Form CMS-1450 (previously Form HCFA-1450) for Inpatient and
    Outpatient Bills
    1895Diabetes Outpatient Self-Management Training Services
    1896Mammography 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
    1897Limitation 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
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    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
    1898Payment 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)
    1808Mandatory Assignment and Participation Program
    Participation Program
    Limiting Charge
    1809Durable 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
    1810Payment for Physician Services Furnished to Dialysis Inpatients
    Dialysis Services (Codes 90935-90999)
    1811Release Software
    Contractor Testing Requirements
    1812Definitions of Lines 1 through 115
    Checking Reports
    Exhibits
    1813Data 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
    1814Screening Mammography Examinations
    Identifying a Screening Mammography Claim and a Diagnostic Mammography Claim
    Adjudicating the Claim
    Diagnostic and Screening Mammograms Performed With New Technologies
    1815Repairs, Maintenance, Replacement, and Delivery
    1816Correct Coding Initiative
    1817Medicare 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)
    1818Filing the Request for Payment
    1819Special Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
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    1820Medicare 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)
    28Provider of Services or Supplier Information
    Program Memorandum Intermediaries
    (CMS Pub. 60A)
    (Superintendent of Documents No. HE 22.8/6-5)
    A-03-057Medicare Program-Update to the Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice for Fiscal Year 2004
    A-03-058Change in Methodology for Determining Payment for Outliers Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment System
    A-03-059Addition of Patient Status Code 43, Deletion of Patient Status Codes 71 and 72, and Information on New Patient Status Code 65
    A-03-060Medicare Program—Update to the Prospective Payment System for Home Health Agencies for Fiscal Year 2004
    A-03-061Tentative Settlement Requirements for Cost Reports from Home Health Agencies and Skilled Nursing Facilities That Have No Reimbursement Impact
    A-03-062Department of Veterans Affairs Claims Adjudication Services Project System Changes Needed
    A-03-063Installation of Version 30 of the Provider Statistical and Reimbursement Reporting System
    A-03-064X12N 837 Institutional Health Care Claim Companion Document
    A-03-065New Common Working File Edits to Ensure Accurate Coding and Payments for Discharge and/or Transfer Policies Under the Inpatient Prospective Payment System
    A-03-066Hospital Outpatient Prospective Payment System Implementation Instructions
    A-03-067The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2002 for Inpatient Prospective Payment System Hospitals
    A-03-068Informing Beneficiaries About Which Local Medical Review Policy and/or National Coverage Determination Is Associated With Their Claim Denial
    A-03-069October Outpatient Code Editor Specification Version (V4.3)
    A-03-070Inclusion 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-03-071Retroactive Correction of Provider Statistical and Reimbursement System Report Data Related to Mammography and Outpatient Therapy Services
    A-03-072Instructions for Provider Credit Balance Reporting Related Activities
    A-03-073Fiscal Year 2004 Inpatient Prospective Payment System, Long Term Care Hospital, and Other Billing Changes
    A-03-074Inpatient Rehabilitation Facility Annual Update: Prospective Payment System Pricer Changes for Fiscal Year 2004
    A-03-075Medicare Part A Skilled Nursing Facility Prospective Payment System Update
    A-03-076October 2003 Update of the Hospital Outpatient Prospective Payment System
    A-03-077October Medicare Outpatient Code Editor Specification Version 19.0 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
    A-03-078Reimbursement for Automated Multi-Channel Chemistry Tests for End-Stage Renal Disease Beneficiaries
    A-03-079Installation of Version 31 of the Provider Statistical and Reimbursement Reporting System
    A-03-080End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Test
    A-03-081Conflicting Policies With Provider Reimbursement Manual 15-1, Section 2771
    A-03-082Clarification 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-03-050Multiple Primary Payers on Part B Claims-Revision to Change Request 2050
    B-03-051Therapy Modifier Bypass for Ambulance Claims
    B-03-052Addition of Temporary “Q” Codes for Drugs Used in Infusion Pumps
    B-03-053Healthcare Provider Taxonomy Codes Crosswalk
    B-03-054Establishing 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-03-055Common Working File crossover Editing for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Claims During an Inpatient Stay
    B-03-056Durable 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-03-057Additional Guidelines for Implementing the National Council for Prescription Drug Program Format
    B-03-058Procedures 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
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    B-03-059Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Single Drug Pricer
    B-03-060Expansion 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-03-061Durable Medical Equipment Regional Carriers National Council of Prescription of Drug Programs Crosswalk Requirements
    B-03-062Procedures for Non-Medicare Secondary Payer Overpayments With Original Balance Less than $10
    B-03-063Healthcare Provider Taxonomy Codes Crosswalk
    B-03-064Clarification—ICD-9 Coding
    B-03-065Changes to Code List for Therapy Services
    B-03-066Durable Medical Equipment Regional Carriers—Eliminate Combined Working File Edit for Cancer Diagnosis for National Drug Codes
    B-03-067National Council for Prescription Drug Programs Batch Transmittal Standard 1.1 Billing Request Companion Document
    B-03-0682004 Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers
    B-03-069Schedule 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-03-094October 2003 Quarterly Updates for Skilled Nursing Facility Consolidated Billing
    AB-03-095Remittance Advice Remark and Reason Code Update
    AB-03-096Quarterly Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement
    AB-03-097Delay in Implementation of Outpatient Therapy Caps to September 1, 2003
    AB-03-098Medicare Summary Notice Implementation for Contractors Using Arkansas Part A Standard System and HCFA Part B Standard System
    AB-03-099Instructions for Fiscal Intermediary Standard System and Multi-Carriers System Healthcare Integrated General Ledger Accounting System Changes
    AB-03-100October Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
    AB-03-101Clarification for CR 2562: Collection of Fee-for-Service Payments Made During Periods of Managed Care Enrollment
    AB-03-102Clarifications Regarding Coverage of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Wounds of the Lower Extremities
    AB-03-103Medicare Secondary Payer Debt Referral and Write-Off Closed Instructions
    AB-03-104Changes to the Laboratory National Coverage Determination Edit Software for October 1, 2003
    AB-03-105Harkin Grantees: Complaint Tracking System and Aggregate Reports
    AB-03-106Third Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule
    AB-03-107Federal Bankruptcy/State Insurer Liquidation Actions and Medicare Secondary Payer Debt
    AB-03-108Medicare 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-03-109Discontinue Use of the Healthcare Integrity and Protection Data Bank for Provider Enrollment Only
    AB-03-110Adjustment to the Rural Mileage Payment Rate for Ground Ambulance Services
    AB-03-111Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing
    AB-03-112Transmittal AB-03-112 Has Been Rescinded
    AB-03-113Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System
    AB-03-114Claims Processing and Payment of Incomplete Screening Colonoscopies
    AB-03-115Payment Denial for Medicare Services Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States
    AB-03-116Update of Rates and Wage Index for Ambulatory Surgical Center Payment Effective October 1, 2003
    AB-03-117Contractor 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-03-118Cease Further Work on the Eligibility File-Based Standard Trading Partner Agreement for the Purpose of Coordination of Benefits
    AB-03-119Final Update to the 2003 Medicare Physician Fee Schedule Database
    AB-03-120Medicare 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-03-121Requirement to Cross Claims Over to Multiple Supplemental Insurers
    AB-03-122Notice of Interest Rate for Medicare Overpayments and Underpayments
    AB-03-123Scheduled Release for October Updates to Software Programs and Pricing/Coding Files
    AB-03-124Standard System Automation of the Notice of Change to Medicare Secondary Payer Auxiliary File Process
    AB-03-125Consolidation of Claims Cross-Over Process
    AB-03-126Change in Type of Service for L04080
    AB-03-127Payment for Fecal Leukocyte Examination Under Clinical Laboratory Improvement Amendments of 1988 Certificate for Provider-Performed Microscopy Procedures During Calendar Year 2003
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    AB-03-128Clarification to Transmittal AB-03-044 (CR 2611), Addition of New Temporary “K” Codes
    AB-03-129Addition 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-03-130Levocarnitine for Use in the Treatment of Carnitine Deficiency in End-Stage Renal Disease Patients
    AB-03-131Update 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-03-132Provider Education Article: Guidelines for Medicare Part B Laboratory Testing
    AB-03-133Managing Medicare Appeals Workloads in Fiscal Year 2004
    AB-03-134Modifier and Condition Code for Providers to Use When Billing for Implantable Automatic Defibrillators for Beneficiaries in Medicare+Choice Plan
    AB-03-135Darbepoetin Alfa (Trade Name Aranesp) and Epoetin Alfa (Trade Name Epogen) for Treatment of Anemia in End-Stage Renal Disease Patients on Dialysis
    AB-03-136Correction to Quarterly Update of Health Care Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement
    AB-03-137Update 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-03-138Modification of Medicare Policy for Erythropoietin
    AB-03-139Appeals Quality Improvement and Data Analysis Activities
    AB-03-1402004 Healthcare Common Procedure Coding System Annual Update Reminder
    AB-03-141CMS Companion Document for the Accredited Standards Committee X12N276/277 Health Care Claim Status Request and Response
    AB-03-142The 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-03-143Implementation 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-03-144Establishing 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-03-145Instructions for Contractors Other Than the Religious Nonmedical Health Care Institution Specialty Intermediary Regarding Claims For Beneficiaries With Religious Nonmedical Health Care Institution Elections
    AB-03-146Reminder Notice of the Implementation of the Ambulance Transition Schedule
    AB-03-147Core Elements and Required Statements for a Valid Privacy Authorization
    State Operations Manual
    (CMS Pub. 7)
    (Superintendent of Documents No. HE 22.8/12)
    31Regional Offices Assignment of Provider and Supplier Identification Number
    Hospice Manual
    (CMS Pub. 10)
    (Superintendent of Documents No. HE 22.8/2)
    806Hospital Manual, Credit Balance Reporting Requirements—General Provisions
    Payment of Amounts Owed Medicare
    Medicare Credit Balance Reporting Certification Page
    807Payment for Services Furnished by a Critical Access Hospital
    Home Health Agency Manual
    (CMS Pub. 11)
    (Superintendent of Documents No. HE 33.8/5)
    305Diabetes Outpatient Self-Management Training
    306Home 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)
    377Credit Balance Reporting Requirements—General Provisions
    Payment of Amounts Owed Medicare
    Medicare Credit Balance Report Certification Page
    Start Printed Page 74597
    Coverage Issues Manual
    (CMS Pub. 6)
    (Superintendent of Documents No. HE 22.8/14)
    173Implantable Automatic Defibrillators
    Peer Review Organization (CMS Pub. 19)
    (Superintendent of Documents No. 22.8/8-15)
    91Case 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.
    92Denials, 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.
    93Agreements—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.
    94Confidentiality and Disclosure—has been moved to the Corresponding Internet-Only Manual, which can be found at http://www.cms.hhs.gov/​manuals.
    95Outreach 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.
    96Payment 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.
    97Beneficiary 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.
    98Data 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)
    69Hospice 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)
    18Outpatient 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)
    39Rural 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)
    96Renal 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
    Start Printed Page 74598
    Provider Reimbursement Manual
    Part 2 Provider Cost Reporting Forms and Instructions
    (CMS Pub. 15-2-11)
    5Reimbursement Information
    ESRD Network Organizations Manual
    (CMS Pub. 81)
    (Superintendent of Documents No. HE 22.9/4)
    15Background 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)
    3New 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)
    19Intermediary Claims Accounts Receivable
    Medicare Program Integrity
    (CMS Pub. 100-08)
    44When 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
    45Focused Medical Review Activity Report
    46Prepayment Edits
    47Data Analysis
    Centers for Medicare & Medicaid Services Mandated Edits
    48Written Orders Prior to Delivery
    49Denial Notices
    50Instructions for Processing Advance Determination of Medicare Coverage Request
    51Update 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)
    2Introduction
    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
    3Introduction
    Quality Improvement Project Process
    Developing and Conducting Interventions
    Documenting and Disseminating Results
    Centers for Medicare & Medicaid Services Project Support and Guidance Activities
    Start Printed Page 74599
    Related Activities Through Quality Improvement Organizations, Carrier, Intermediary, and End-Stage Renal Diseases Network Cooperation
    4Beneficiary Request for Review of Hospital-Issued Notice of Non-Coverage by a Quality Improvement Organization
    5Intermediary/Carrier Memorandum of Agreement Specifications
    Introduction
    Memorandum of Agreement With State Agencies Responsible for Licensing/Certification of Providers/Practitioners
    6Statutory 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
    7Beneficiary 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
    8Introduction
    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
    9Scope 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
    10Authority
    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)
    1Forward
    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
    2Forward
    Purpose of the Network Manual
    Statutes and Regulations
    Start 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
    3Organizational 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)
    26Alternate 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
    27Noncontracted Provider Appeals
    Storage of Appeal Case Files by the Independent Review Entity
    Representative Filing on Behalf of the Enrollee
    Storage of Hearing Files
    28Streamlined 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
    29Introduction
    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
    Start Printed Page 74601
    Obligations of Deemed Medicare and Medicaid Organizations
    Oversight of Accrediting Organizations
    Application Requirements
    Reporting Requirements
    Informal Hearing Procedures
    30Reasonable 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
    31Overview 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
    Start 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 dateFR Vol. 68 page No.CFR parts affectedFile codeTitle of regulation
    July 2, 200339764CMS-1473-NCMedicare Program; Home Health Prospective Payment System Rate Update for FY 2004.
    July 15, 200341861OFR CorrectionMedicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes.
    July 25, 200344091CMS-3117-NMedicare Program; Meeting of the Medicare Coverage Advisory Committee September 9, 2003.
    July 25, 200344089CMS-1260-NMedicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 22, 2003.
    July 25, 200344088CMS-3124-WNMedicare Program; Withdrawal of Medicare Coverage of Multiple-Seizure Electroconvulsive Therapy, Electrodiagnostic Sensory Nerve Conduction Threshold Testing, and Noncontact Normothermic Wound Therapy.
    July 25, 20034400042 CFR Part 424CMS-1185-PMedicare Program; Elimination of Statement of Intent Procedures for Filing Medicare Claims.
    July 25, 20034399842 CFR Part 406CMS-4018-PMedicare Program; Continuation of Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity.
    Start Printed Page 74603
    July 25, 20034399542 CFR Parts 405 and 411CMS-6014-PMedicare Program; Interest Calculation.
    July 25, 20034394042 CFR Parts 411 and 489CMS-1475-FCMedicare Program; Third Party Liability Insurance Regulations.
    August 1, 20034567442 CFR Part 412CMS-1474-FMedicare Program; Changes to the Inpatient Rehabilitation Facility Prospective Payment System and Fiscal Year 2004 Rates.
    August 1, 20034534642 CFR Parts 412 and 413CMS-1470-FMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
    August 4, 20034603642 CFR Parts 409, 411, 413, 440, 483, 488, and 489CMS-1469-FMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.
    August 11, 20034763742 CFR Part 412CMS-1470-FMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
    August 12, 20034796642 CFR Parts 410 and 419CMS-1471-PMedicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates.
    August 15, 20034903042 CFR Parts 410 and 414CMS-1476-PMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004.
    August 15, 20034880542 CFR Part 424CMS-0008-IFCMedicare Program; Electronic Submission of Medicare Claims.
    August 20, 20035042842 CFR Part 405CMS-1229-PMedicare Program; Payment Reform for Part B Drugs.
    August 22, 20035084042 CFR Parts 409, 417, and 422CMS-4041-FMedicare Program; Modifications to Managed Care Rules.
    August 22, 200350794CMS-1236-NMedicare Program; September 15 and 16, 2003, Meeting of the Practicing Physicians Advisory Council and Request for Nominations.
    August 22, 200350793CMS-4053-NMedicare Program: Meeting of the Advisory Panel on Medicare Education—September 18, 2003.
    August 22, 200350790CMS-2136-FNMedicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2002.
    August 22, 200350784CMS-2166-NState 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, 20035073542 CFR Part 414CMS-1167-PMedicare Program; Payment for Respiratory Assist Devices With Bi-level Capability and a Back-up Rate.
    August 22, 200350722CMS-2226-CNMedicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Correction.
    August 22, 20035071742 CFR Part 413CMS-1199-FMedicare Program; Electronic Submission of Cost Reports.
    August 29, 20035191242 CFR Part 447CMS-2175-FCMedicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program.
    September 9, 20035326642 CFR Part 412CMS-1262-PMedicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility.
    September 9, 20035322242 CFR Parts 413, 482, and 489CMS-1063-FMedicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions.
    September 26, 200355634CMS-3062-NMedicare Program; Revised Process for Making Medicare National Coverage Determinations.
    September 26, 200355618CMS-9018-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances—April 2003 Through June 2003.
    September 26, 200355616CMS-2182-FNMedicare and Medicaid Programs; Reapproval of the Community Health Accreditation Program (CHAP) for Deeming Authority for Hospices.
    Start Printed Page 74604
    September 26, 20035556642 CFR Parts 410 and 414CMS-1476-CNMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004; Correction.
    September 26, 20035552842 CFR Parts 483 and 488CMS-2131-FMedicare and Medicaid Programs; Requirements for Paid Feeding Assistants in Long Term Care Facilities.
    September 26, 20035552742 CFR Part 447CMS-2175-CNMedicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction
    September 29, 20035588242 CFR Parts 409, 411, 413, 440, 483, 488, and 489CMS-1469-CNMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction.
    September 30, 200356478CMS-1233-NMedicare Program; Hospice Wage Index for Fiscal Year 2004.
    September 30, 200356383CMS-1473-NC OFR CorrectionMedicare 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 sectionTitleIssue dateEffective date
    35-85.1Implantable Automatic08/22/0310/01/03
    Defibrillators09/22/03 (correction)10/01/03

    Program Memorandum (PM)

    PM No.TitleIssue dateEffective date
    AB-03-104Changes to the Laboratory NCD Edit Software For 10/0307/25/0310/01/03

    Federal Register Publications

    TitlePublication dateEffective date
    CMS-3062-N—Revised Process for Making National Coverage Determinations09/26/03N/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

    IDECategory
    G020202B
    G020312B
    G020316B
    G030027B
    G030031B
    G030040B
    G030059B
    G030066B
    G030100B
    G030121B
    G030131B
    G030133B
    G030134B
    G030135B
    G030136B
    Start Printed Page 74605
    G030137B
    G030138B
    G030141B
    G030143B
    G030144B
    G030145B
    G030146B
    G030147B
    G030151B
    G030159B
    G030162B
    G030165B
    G030167B
    G030169B
    G030170B
    G030172B
    G030173B
    G030174B
    G030177B

    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”)
    0938-0008414.40, 424.32, 424.44
    0938-0022413.20, 413.24, 413.106
    0938-0023424.103
    0938-0025406.28, 407.27
    0938-0027486.100-486.110
    0938-0033405.807
    0938-0034405.821
    0938-0035407.40
    0938-0037413.20, 413.24
    0938-0041408.6
    0938-0042410.40, 424.124
    0938-0045405.711
    0938-0046405.2133
    0938-0050413.20, 413.24
    0938-0062431.151, 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
    0938-0065485.701-485.729
    0938-0074491.1-491.11
    0938-0080406.7, 406.13
    0938-0086420.200-420.206, 455.100-455.106
    0938-0101430.30
    0938-0102413.20, 413.24
    0938-0107413.20, 413.24
    0938-0146431.800-431.865
    0938-0147431.800-431.865
    0938-0151493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489
    0938-0155405.2470
    0938-0170493.1269-493.1285
    0938-0193430.10-430.20, 440.167
    0938-0202413.17, 413.20
    0938-0214411.25, 489.2, 489.20
    0938-0236413.20, 413.24
    0938-0242416.44, 418.100, 482.41, 483.270, 483.470
    0938-0245407.10, 407.11
    0938-0246431.800-431.865
    0938-0251406.7
    0938-0266416.41, 416.47, 416.48, 416.83
    0938-0267410.65, 485.56, 485.58, 485.60, 485.64, 485.66
    0938-0269412.116, 412.632, 413.64, 413.350, 484.245
    0938-0270405.376
    0938-0272440.180, 441.300-441.305
    0938-0273485.701-485.729
    0938-0279424.5
    0938-0287447.31
    0938-0296413.170
    0938-0300431.800
    0938-0301413.20, 413.24
    0938-0302418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100
    0938-0313418.1-418.405
    0938-0328482.12, 482.22, 482.27, 482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66
    0938-0334491.9
    0938-0338486.104, 486.106, 486.110
    0938-0354441.60
    0938-0355484.10-484.52
    0938-0357409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21
    0938-0358412.20-412.30
    Start Printed Page 74606
    0938-0359412.40-412.52
    0938-0360405.2100-405.2184
    0938-0365484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52
    0938-0372414.330
    0938-0378482.60-482.62
    0938-0379442.30, 488.26
    0938-0386405.2100-405.2171
    0938-0391488.18, 488.26, 488.28
    0938-0426476.104, 476.105, 476.116, 476.134
    0938-0429447.53
    0938-0443473.18, 473.34, 473.36, 473.42
    0938-04441004.40, 1004.50, 1004.60, 1004.70
    0938-0445412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78
    0938-0447405.2133
    0938-0449440.180, 441.300-441.310
    0938-0454424.20
    0938-0456412.105
    0938-0463413.20, 413.24
    0938-0465411.404, 411.406, 411.408
    0938-0467431.17, 431.306, 435.910, 435.920, 435.940-435.960
    0938-0469417.107, 417.478
    0938-0470417.143, 417.408
    0938-0477412.92
    0938-0484424.123
    0938-0486498.40-498.95
    0938-0501406.15
    0938-0502433.138
    0938-0512486.301-486.325
    0938-0526462.102, 462.103. 475.100, 475.106, 475.107
    0938-0534410.38, 424.5
    0938-0544493.1-493.2001
    0938-0565411.20-411.206
    0938-0566411.404, 411.406, 411.408
    0938-0567Part 498 Subparts D and E, and 20 CFR 404.933
    0938-0573412.230, 412.256
    0938-0581493.1-493.2001
    0938-0599493.1-493.2001
    0938-0600405.371, 405.378, 413.20
    0938-0610417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102
    0938-0612493.1-493.2001
    0938-0618433.68, 433.74, 447.272
    0938-0653493.1771, 493.1773, 493.1777
    0938-0655493.1840
    0938-0657405.2110, 405.2112
    0938-0658405.2110, 405.2112
    0938-0667482.12, 488.18, 489.20, 489.24
    0938-0673430.10
    0938-0679410.38
    0938-0685410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12
    0938-0686493.551-493.557
    0938-0688486.301-486.325
    0938-0690488.4-488.9, 488.201
    0938-0691412.106
    0938-0692466.78, 489.20, 489.27
    0938-0700417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103, 1003.106
    0938-0701422.152
    0938-070245 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180
    0938-070345 CFR 148.120, 148.124, 148.126, and 148.128
    0938-0714411.370-411.389
    0938-0717424.57
    0938-0721410.33
    0938-0722422.370-422.378
    0938-0723421.300-421.318
    0938-0730405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24
    0938-0732417.126, 417.470
    0938-073445 CFR 5b
    0938-0739413.337, 413.343, 424.32, 483.20
    0938-0742422.300-422.312
    0938-0749424.57
    0938-0753422.000-422.700
    0938-0754441.152
    0938-0758413.20, 413.24
    0938-0760Part 484 Subpart E, 484.55
    Start Printed Page 74607
    0938-0761484.11, 484.20
    0938-0763422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622
    0938-0768417.800-417.840
    0938-0770410.2
    0938-0778422.64, 422.111, 422.560-422.622
    0938-0779417.126, 417.470, 422.64, 422.210
    0938-0781411.404-411.406, 484.10
    0938-0786438.352, 438.360, 438.362, 438.364
    0938-0787406.28, 407.27
    0938-0790460.12, 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
    0938-0792491.3, 491.8, 491.11
    0938-0798413.24, 413.65, 419.42
    0938-0802419.43
    0938-0810482.45
    0938-081945 CFR 146.121
    0938-0823420.410
    0938-0824440.10, 482.13
    0938-082745 CFR 146.141
    0938-0829422.568
    0938-0832Part 489
    0938-0833483.350-483.376
    0938-0841431.636, 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
    0938-0842412, 413
    0938-0846411.1, 411.350-411.357, 424.22
    0938-0857Part 419
    0938-0860Part 419
    0938-086645 CFR Part 162
    0938-0872413.337, 483.20
    0938-0873422.152
    0938-087445 CFR Parts 160 and 162
    0938-0878Part 422 Subparts F and G
    0938-088345 CFR Parts 160 and 164
    0938-088745 CFR 148.316, 148.318, 148.320
    0938-0897412.22, 412.533
    End Supplemental Information

    [FR Doc. 03-30756 Filed 12-23-03; 8:45 am]

    BILLING CODE 4120-01-P

Document Information

Published:
12/24/2003
Department:
Centers for Medicare & Medicaid Services
Entry Type:
Notice
Action:
Notice.
Document Number:
03-30756
Dates:
Prospective Payment System Pricer
Pages:
74590-74607 (18 pages)
Docket Numbers:
CMS-9019-N
PDF File:
03-30756.pdf