[Federal Register: December 24, 2003 (Volume 68, Number 247)] [Notices] [Page 74590-74607] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24de03-91] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9019-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July 2003 Through September 2003 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2003 through September 2003, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.) Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252. Questions concerning national coverage determinations in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09- 06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261. Questions concerning Investigational Device Exemptions items in Addendum VI may be addressed to Sharon Hippler, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C5-13- 27, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4633. Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Dawn Willinghan, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-09- 26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6141. Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-12-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954. SUPPLEMENTARY INFORMATION: I. Program Issuances The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) Furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently. Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame. II. How To Use the Addenda This notice is organized so that a reader may review the subjects of manual issuances, memoranda, [[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: [sbull] Addendum I lists the publication dates of the most recent quarterly listings of program issuances. [sbull] Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda. [sbull] 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. [sbull] 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-- [sbull] Date published; [sbull] Federal Register citation; [sbull] Parts of the Code of Federal Regulations (CFR) that have changed (if applicable); [sbull] Agency file code number; and [sbull] Title of the regulation. [sbull] 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. [sbull] 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. [sbull] 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: [sbull] Titles XI, XVIII, and XIX of the Act. [sbull] CMS-related regulations. [sbull] CMS manuals and monthly revisions. [sbull] 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 [[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 [sbull Frequency of Billing ] ...... Provider Education 1893 [sbull Release Software ] 1894 [sbull Review of Form CMS-1450 (previously Form ] HCFA-1450) for Inpatient and ...... Outpatient Bills 1895 [sbull Diabetes Outpatient Self-Management ] Training Services 1896 [sbull 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 [sbull 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 [[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 [sbull 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 [sbull Mandatory Assignment and Participation ] Program ...... Participation Program ...... Limiting Charge 1809 [sbull 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 [sbull Payment for Physician Services Furnished to ] Dialysis Inpatients ...... Dialysis Services (Codes 90935-90999) 1811 [sbull Release Software ] ...... Contractor Testing Requirements 1812 [sbull Definitions of Lines 1 through 115 ] ...... Checking Reports ...... Exhibits 1813 [sbull 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 [sbull 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 [sbull Repairs, Maintenance, Replacement, and ] Delivery 1816 [sbull Correct Coding Initiative ] 1817 [sbull 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 [sbull Filing the Request for Payment ] 1819 [sbull Special Requirements for Claims for Durable ] Medical Equipment, Prosthetics, Orthotics, and Supplies [[Page 74594]] 1820 [sbull 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 [sbull Provider of Services or Supplier ] Information ------------------------------------------------------------------------ Program Memorandum Intermediaries (CMS Pub. 60A) (Superintendent of Documents No. HE 22.8/6-5) ------------------------------------------------------------------------ A-03-057 [sbull Medicare Program-Update to the Hospice ] Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice for Fiscal Year 2004 A-03-058 [sbull 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 [sbull 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 [sbull Medicare Program--Update to the Prospective ] Payment System for Home Health Agencies for Fiscal Year 2004 A-03-061 [sbull Tentative Settlement Requirements for Cost ] Reports from Home Health Agencies and Skilled Nursing Facilities That Have No Reimbursement Impact A-03-062 [sbull Department of Veterans Affairs Claims ] Adjudication Services Project System Changes Needed A-03-063 [sbull Installation of Version 30 of the Provider ] Statistical and Reimbursement Reporting System A-03-064 [sbull X12N 837 Institutional Health Care Claim ] Companion Document A-03-065 [sbull 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 [sbull Hospital Outpatient Prospective Payment ] System Implementation Instructions A-03-067 [sbull The Supplemental Security Income Medicare ] Beneficiary Data for Fiscal Year 2002 for Inpatient Prospective Payment System Hospitals A-03-068 [sbull Informing Beneficiaries About Which Local ] Medical Review Policy and/or National Coverage Determination Is Associated With Their Claim Denial A-03-069 [sbull October Outpatient Code Editor ] Specification Version (V4.3) A-03-070 [sbull 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 [sbull Retroactive Correction of Provider ] Statistical and Reimbursement System Report Data Related to Mammography and Outpatient Therapy Services A-03-072 [sbull Instructions for Provider Credit Balance ] Reporting Related Activities A-03-073 [sbull Fiscal Year 2004 Inpatient Prospective ] Payment System, Long Term Care Hospital, and Other Billing Changes A-03-074 [sbull Inpatient Rehabilitation Facility Annual ] Update: Prospective Payment System Pricer Changes for Fiscal Year 2004 A-03-075 [sbull Medicare Part A Skilled Nursing Facility ] Prospective Payment System Update A-03-076 [sbull October 2003 Update of the Hospital ] Outpatient Prospective Payment System A-03-077 [sbull 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 [sbull Reimbursement for Automated Multi-Channel ] Chemistry Tests for End-Stage Renal Disease Beneficiaries A-03-079 [sbull Installation of Version 31 of the Provider ] Statistical and Reimbursement Reporting System A-03-080 [sbull End-Stage Renal Disease Reimbursement for ] Automated Multi-Channel Chemistry Test A-03-081 [sbull Conflicting Policies With Provider ] Reimbursement Manual 15-1, Section 2771 A-03-082 [sbull 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 [sbull Multiple Primary Payers on Part B Claims- ] Revision to Change Request 2050 B-03-051 [sbull Therapy Modifier Bypass for Ambulance ] Claims B-03-052 [sbull Addition of Temporary ``Q'' Codes for Drugs ] Used in Infusion Pumps B-03-053 [sbull Healthcare Provider Taxonomy Codes ] Crosswalk B-03-054 [sbull 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 [sbull Common Working File crossover Editing for ] Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Claims During an Inpatient Stay B-03-056 [sbull 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 [sbull Additional Guidelines for Implementing the ] National Council for Prescription Drug Program Format B-03-058 [sbull 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 [[Page 74595]] B-03-059 [sbull Minimum Number of Pricing Files That Must ] Be Maintained Online for Medicare Single Drug Pricer B-03-060 [sbull 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 [sbull Durable Medical Equipment Regional Carriers ] National Council of Prescription of Drug Programs Crosswalk Requirements B-03-062 [sbull Procedures for Non-Medicare Secondary Payer ] Overpayments With Original Balance Less than $10 B-03-063 [sbull Healthcare Provider Taxonomy Codes ] Crosswalk B-03-064 [sbull Clarification--ICD-9 Coding ] B-03-065 [sbull Changes to Code List for Therapy Services ] B-03-066 [sbull Durable Medical Equipment Regional ] Carriers--Eliminate Combined Working File Edit for Cancer Diagnosis for National Drug Codes B-03-067 [sbull National Council for Prescription Drug ] Programs Batch Transmittal Standard 1.1 Billing Request Companion Document B-03-068 [sbull 2004 Annual Update for Skilled Nursing ] Facility Consolidated Billing for the Common Working File and Medicare Carriers B-03-069 [sbull 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 [sbull October 2003 Quarterly Updates for Skilled ] Nursing Facility Consolidated Billing AB-03-095 [sbull Remittance Advice Remark and Reason Code ] Update AB-03-096 [sbull Quarterly Update of Healthcare Common ] Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement AB-03-097 [sbull Delay in Implementation of Outpatient ] Therapy Caps to September 1, 2003 AB-03-098 [sbull Medicare Summary Notice Implementation for ] Contractors Using Arkansas Part A Standard System and HCFA Part B Standard System AB-03-099 [sbull Instructions for Fiscal Intermediary ] Standard System and Multi-Carriers System Healthcare Integrated General Ledger Accounting System Changes AB-03-100 [sbull October Quarterly Update for 2003 Durable ] Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule AB-03-101 [sbull Clarification for CR 2562: Collection of ] Fee-for-Service Payments Made During Periods of Managed Care Enrollment AB-03-102 [sbull Clarifications Regarding Coverage of ] Hyperbaric Oxygen Therapy for the Treatment of Diabetic Wounds of the Lower Extremities AB-03-103 [sbull Medicare Secondary Payer Debt Referral and ] Write-Off Closed Instructions AB-03-104 [sbull Changes to the Laboratory National Coverage ] Determination Edit Software for October 1, 2003 AB-03-105 [sbull Harkin Grantees: Complaint Tracking System ] and Aggregate Reports AB-03-106 [sbull Third Clarification of Medicare Policy ] Regarding the Implementation of the Ambulance Fee Schedule AB-03-107 [sbull Federal Bankruptcy/State Insurer ] Liquidation Actions and Medicare Secondary Payer Debt AB-03-108 [sbull 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 [sbull Discontinue Use of the Healthcare Integrity ] and Protection Data Bank for Provider Enrollment Only AB-03-110 [sbull Adjustment to the Rural Mileage Payment ] Rate for Ground Ambulance Services AB-03-111 [sbull Shared System Maintainer Hours for ] Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing AB-03-112 [sbull Transmittal AB-03-112 Has Been Rescinded ] AB-03-113 [sbull Update of Codes in the Program Integrity ] Management Reporting System and the Contractor Administrative Cost and Financial Management System AB-03-114 [sbull Claims Processing and Payment of Incomplete ] Screening Colonoscopies AB-03-115 [sbull Payment Denial for Medicare Services ] Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States AB-03-116 [sbull Update of Rates and Wage Index for ] Ambulatory Surgical Center Payment Effective October 1, 2003 AB-03-117 [sbull 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 [sbull Cease Further Work on the Eligibility File- ] Based Standard Trading Partner Agreement for the Purpose of Coordination of Benefits AB-03-119 [sbull Final Update to the 2003 Medicare Physician ] Fee Schedule Database AB-03-120 [sbull 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 [sbull Requirement to Cross Claims Over to ] Multiple Supplemental Insurers AB-03-122 [sbull Notice of Interest Rate for Medicare ] Overpayments and Underpayments AB-03-123 [sbull Scheduled Release for October Updates to ] Software Programs and Pricing/Coding Files AB-03-124 [sbull Standard System Automation of the Notice of ] Change to Medicare Secondary Payer Auxiliary File Process AB-03-125 [sbull Consolidation of Claims Cross-Over Process ] AB-03-126 [sbull Change in Type of Service for L04080 ] AB-03-127 [sbull Payment for Fecal Leukocyte Examination ] Under Clinical Laboratory Improvement Amendments of 1988 Certificate for Provider-Performed Microscopy Procedures During Calendar Year 2003 [[Page 74596]] AB-03-128 [sbull Clarification to Transmittal AB-03-044 (CR ] 2611), Addition of New Temporary ``K'' Codes AB-03-129 [sbull 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 [sbull Levocarnitine for Use in the Treatment of ] Carnitine Deficiency in End-Stage Renal Disease Patients AB-03-131 [sbull 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 [sbull Provider Education Article: Guidelines for ] Medicare Part B Laboratory Testing AB-03-133 [sbull Managing Medicare Appeals Workloads in ] Fiscal Year 2004 AB-03-134 [sbull Modifier and Condition Code for Providers ] to Use When Billing for Implantable Automatic Defibrillators for Beneficiaries in Medicare+Choice Plan AB-03-135 [sbull 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 [sbull Correction to Quarterly Update of Health ] Care Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement AB-03-137 [sbull 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 [sbull Modification of Medicare Policy for ] Erythropoietin AB-03-139 [sbull Appeals Quality Improvement and Data ] Analysis Activities AB-03-140 [sbull 2004 Healthcare Common Procedure Coding ] System Annual Update Reminder AB-03-141 [sbull CMS Companion Document for the Accredited ] Standards Committee X12N276/277 Health Care Claim Status Request and Response AB-03-142 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [sbull Reminder Notice of the Implementation of ] the Ambulance Transition Schedule AB-03-147 [sbull 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 [sbull Regional Offices Assignment of Provider and ] Supplier Identification Number ------------------------------------------------------------------------ Hospice Manual (CMS Pub. 10) (Superintendent of Documents No. HE 22.8/2) ------------------------------------------------------------------------ 806 [sbull Hospital Manual, Credit Balance Reporting ] Requirements--General Provisions ...... Payment of Amounts Owed Medicare ...... Medicare Credit Balance Reporting Certification Page 807 [sbull 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 [sbull Diabetes Outpatient Self-Management ] Training 306 [sbull 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 [sbull Credit Balance Reporting Requirements-- ] General Provisions ...... Payment of Amounts Owed Medicare ...... Medicare Credit Balance Report Certification Page ------------------------------------------------------------------------ [[Page 74597]] Coverage Issues Manual (CMS Pub. 6) (Superintendent of Documents No. HE 22.8/14) ------------------------------------------------------------------------ 173 [sbull Implantable Automatic Defibrillators ] ------------------------------------------------------------------------ Peer Review Organization (CMS Pub. 19) (Superintendent of Documents No. 22.8/8-15) ------------------------------------------------------------------------ 91 [sbull Case Review and Health Care Quality ] Improvement Program--has been moved to Corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/ manuals. 92 [sbull Denials, Reconsiderations and Appeals--has ] been moved to corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organization Manual, which can be found at http://www.cms.hhs.gov/manuals . 93 [sbull Agreements--has been moved to Corresponding ] Internet-Only Manual chapter in Pub. 100- 10, Medicare Quality Improvement Organization Manual, which can be found at http://www.cms.hhs.gov/manuals. 94 [sbull Confidentiality and Disclosure--has been ] moved to the Corresponding Internet-Only Manual, which can be found at http://www.cms.hhs.gov/manuals . 95 [sbull Outreach Activities--has been moved to ] corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/ manuals. 96 [sbull Payment Error Prevention Program--has been ] moved to corresponding Internet-Only Manual chapter in Pub.100-10, Medicare Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/ manuals. 97 [sbull Beneficiary Complaint Review--has been ] moved to corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/manuals . 98 [sbull Data Management--has been moved to ] corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/ manuals. ------------------------------------------------------------------------ Hospice Manual (CMS Pub. 21) (Superintendent of Documents No. HE 22.8/18) ------------------------------------------------------------------------ 69 [sbull 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 [sbull 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 [sbull 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 [sbull 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 ------------------------------------------------------------------------ [[Page 74598]] Provider Reimbursement Manual ------------------------------------------------------------------------ Part 2 Provider Cost Reporting Forms and Instructions Chapter 11/Form CMS 22.8/4 (CMS Pub. 15-2-11) 5 [sbull Reimbursement Information ] ------------------------------------------------------------------------ ESRD Network Organizations Manual ------------------------------------------------------------------------ (CMS Pub. 81) (Superintendent of Documents No. HE 22.9/4) 15 [sbull 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 [sbull 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 [sbull Intermediary Claims Accounts Receivable ] ------------------------------------------------------------------------ Medicare Program Integrity ------------------------------------------------------------------------ (CMS Pub. 100-08) 44 [sbull 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 [sbull Focused Medical Review Activity Report ] 46 [sbull Prepayment Edits ] 47 [sbull Data Analysis ] ...... Centers for Medicare & Medicaid Services Mandated Edits 48 [sbull Written Orders Prior to Delivery ] 49 [sbull Denial Notices ] 50 [sbull Instructions for Processing Advance ] Determination of Medicare Coverage Request 51 [sbull 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 [sbull 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 [sbull Introduction ] ...... Quality Improvement Project Process ...... Developing and Conducting Interventions ...... Documenting and Disseminating Results ...... Centers for Medicare & Medicaid Services Project Support and Guidance Activities [[Page 74599]] ...... Related Activities Through Quality Improvement Organizations, Carrier, Intermediary, and End-Stage Renal Diseases Network Cooperation 4 [sbull Beneficiary Request for Review of Hospital- ] Issued Notice of Non-Coverage by a Quality Improvement Organization 5 [sbull Intermediary/Carrier Memorandum of ] Agreement Specifications ...... Introduction ...... Memorandum of Agreement With State Agencies Responsible for Licensing/Certification of Providers/Practitioners 6 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [sbull Forward ] ...... Purpose of the Network Manual ...... Statutes and Regulations [[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 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [sbull 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 [[Page 74601]] ...... Obligations of Deemed Medicare and Medicaid Organizations ...... Oversight of Accrediting Organizations ...... Application Requirements ...... Reporting Requirements ...... Informal Hearing Procedures 30 [sbull 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 [sbull 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 [[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] -------------------------------------------------------------------------------------------------------------------------------------------------------- FR Vol. 68 Publication date 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. [[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, CMS-1469-F........................... Medicare Program; 488, and 489. 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. [[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, CMS-1469-CN.......................... Medicare Program; 488, and 489. Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction. September 30, 2003................... 56478 ..................................... CMS-1233-N........................... Medicare Program; Hospice Wage Index for Fiscal Year 2004. September 30, 2003................... 56383 ..................................... CMS-1473-NC OFR Correction........... Medicare Program; Home Health Prospective Payment System Rate Update for FY 2004; Correction. -------------------------------------------------------------------------------------------------------------------------------------------------------- Addendum V--National Coverage Determinations [July 2003 Through September 2003] A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at http://cms.hhs.gov/coverage . National Coverage Decisions [July 2003 Through September 2003] Coverage Issues Manual (CIM) (CMS Pub. 06) ---------------------------------------------------------------------------------------------------------------- CIM section Title Issue date Effective date ---------------------------------------------------------------------------------------------------------------- 35-85.1................................. Implantable Automatic..... 08/22/03.................. 10/01/03 Defibrillators............ 09/22/03 (correction)..... 10/01/03 ---------------------------------------------------------------------------------------------------------------- Program Memorandum (PM) ------------------------------------------------------------------------ PM No. Title Issue date Effective date ------------------------------------------------------------------------ AB-03-104............. Changes to the 07/25/03 10/01/03 Laboratory NCD Edit Software For 10/03. ------------------------------------------------------------------------ Federal Register Publications ------------------------------------------------------------------------ Publication Title date Effective date ------------------------------------------------------------------------ CMS-3062-N--Revised Process for Making 09/26/03 N/A National Coverage Determinations....... ------------------------------------------------------------------------ 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 [[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: ------------------------------------------------------------------------ Approved CFR sections in Title 42, Title 45, and Title 20 (Note: sections in Title OMB control Nos. 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 [[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 [[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