Medicare and medicaid: Program issuances and coverage decisions; quarterly listing,
[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55618-55634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-74]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9018-N]
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--April 2003 Through June 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 April 2003 through June 2003, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations affecting specific medical and health care
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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 Margie Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4678.
SUPPLEMENTARY INFORMATION:
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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.
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How To Use the Addenda
This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, national coverage determinations (NCDs), and Food and Drug Administration (FDA)-approved investigational device exemptions (IDEs) published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare Coverage Issues Manual (CIM) may wish to review the August 21, 1989 publication (54 FR 34555). Those interested in the procedures used in making NCDs under the Medicare program may review the April 27, 1999 publication (64 FR 22619).
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 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
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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.
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How To Obtain Listed Material
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Manuals
Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:
Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: http://cms.hhs.gov/manuals/default.asp.
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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).
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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.
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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.
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How To Review Listed Material
Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL.
In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library.
Superintendent of Documents numbers for each CMS publication are shown in Addendum III, along with the CMS publication and transmittal numbers. To help FDLs locate the materials, use the Superintendent of Documents number, plus the transmittal number. For example, to find the Carriers Manual, Part 3--Program Administration (CMS Pub. 14-3) transmittal entitled ``Incident to Physician's Professional Services (Subsection A--Commonly Furnished in Physicians' Offices),'' use the Superintendent of Documents No. HE 22.8/7 and the transmittal number 1793.
(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: September 8, 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.
May 11, 1999 (64 FR 25351) November 2, 1999 (64 FR 59185) December 7, 1999 (64 FR 68357) January 10, 2000 (65 FR 1400) May 30, 2000 (65 FR 34481) June 28, 2002 (67 FR 43762) September 27, 2002 (67 FR 61130) December 27, 2002 (67 FR 79109) March 28, 2003 (68 FR 15196) June 27, 2003 (68 FR 38359)
Addendum II.--Description of Manuals, Memoranda, and CMS Rulings
An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the Medicare Coverage Issues Manual (CIM) 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.
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Addendum III.--Medicare and Medicaid Manual Instructions [April 2003 Through June 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)
1879
[sbull Clinical Diagnostic Laboratory Services ] Other Than To Inpatients Screening Pap Smears and Pelvic Examinations 1880
[sbull Autologous Stem Cell Transplantation ] 1881
[sbull Review of Form HCFA-1450 for Inpatient and ] Outpatient Bills 1882
[sbull Frequency of Billing ] 1883
[sbull Magnetic Resonance Angiography ] 1884
[sbull Telehealth Services ] 1885
[sbull Medicare Payment for Telehealth Services ] 1886
[sbull Payment Without Common Working File ] Approval 1887
[sbull Filing a Request for Payment ] ...... Request for Payment ...... Filing Claims for Payment ...... Time Limits for Requests and Claims for Payment for Services Reimbursed ...... Effects on Beneficiary and Provider of Beneficiary's Refusal to File a Request for Payment ...... Filing Claims Where Usual Time Limit Has Expired ...... Claims for Payment for Emergency Hospital Services and Services Outside the United States ...... Appeals ...... Time Limits for Filing Part B Reasonable Charge Claims ...... Claims Processing Timeliness ...... Time Limitations for Filing Provider Claims ...... Incomplete or Invalid Claims ...... Addendum L Paper and Electronic Data Element Requirements ...... Bill Type Codes and Allowable Provider Numbers 1888
[sbull Screening Pap Smears and Screening Pelvic ] Examinations 1889
[sbull Billing of the Diagnosis and Treatment of ] Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes 1890
[sbull Coverage and Billing of Sacral Nerve ] Stimulation ...... Deep Brain Stimulation for Essential Tremor and Parkinson's Disease 1891
[sbull International Classification of Diseases ] 9th Edition ...... Clinical Modification Coding for Diagnostic Tests
Carriers Manual Part 3--Program Administration (CMS Pub. 14-3) (Superintendent of Documents No. HE 22.8/7)
1793
[sbull Incident to Physician's Professional ] Services (Subsection A--Commonly Furnished in Physicians' Offices) 1794
[sbull The ``Do Not Forward'' Initiative ] (Subsection C--Internal Revenue Services-- 1099 Reporting) 1795
[sbull Magnetic Resonance Angiography Coverage ] Summary Coding Requirements 1796
[sbull Skilled Nursing Facility Consolidated ] Billing ...... Determining the End of a Skilled Nursing Facility Stay ...... Types of Facilities Included in and Excluded From Consolidated Billing ...... Types of Services Included in and Excluded From Consolidated Billing ...... Risk-Based Health Maintenance Organization Beneficiaries ...... Clarification of Ambulance Services ...... Information on a Skilled Nursing Facility Contracting With Outside Entities for Services ...... Carrier Claims Processing ...... Special Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies ...... Revisions to Common Working File Edits To Permit Payment for Certain Diagnostic Services Furnished To Beneficiaries Receiving Treatment for End-Stage Renal Disease at an Independent or Provider- Based Dialysis Facility 1797
[sbull Telehealth Claims ] 1798
[sbull Medicare Payment for Telehealth Services ] 1799
[sbull Payment Limit for Certain Drugs and ] Biologicals ...... Procedures for Determining Payment Limit ...... Injection Services ...... Mandatory Assignment for Drugs and Biologicals 1800
[sbull Drugs and Biologicals ] ...... Definition of Drug or Biological ...... Determining Self-Administration of Drugs or Biologicals Incident-To Requirements 1801
[sbull Healthcare Common Procedure Coding System ] Coding ...... Common Working File Edits for Flu and Pneumonia Claims ...... Administrative Bulletin Crossover Edit ...... Payment Requirements ...... No Legal Obligation To Pay ...... Roster Billing ...... Health Maintenance Organization Processing
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...... Specialty Code/Place of Service Processing 1802
[sbull Foot Care and Supportive Devices for Feet ] Foot Care ...... Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes ...... Coverage ...... Applicable Codes ...... Payment Requirements ...... Standard System Edits ...... Common Working File Edits 1803
[sbull End-Stage Renal Disease Bill Procedures ] 1804 1804
[sbull Durable Medical Equipment Regional ] Carriers--Pre-Discharge Delivery of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Fitting and Training 1805
[sbull Necessity for Treatment ] 1806
[sbull Intestinal and Multi-Visceral ] Transplantation ...... Approved Transplant Facilities ...... Payment Procedures for Intestinal and Multi- Visceral Transplants 1807
[sbull International Classification of Diseases ] 9th Edition Clinical Modification ...... Coding for Diagnostic Tests
Program Memorandum Intermediaries (CMS Pub. 60A) (Superintendent of Documents No. HE 22.8/6-5)
A-03-020
[sbull April 2003 Update of the Hospital ] Outpatient Prospective Payment System A-03-021
[sbull Announcement of Medicare Rural Health ] Clinics and Federally Qualified ...... Health Centers Payment Rate Increases, Clarification on Coverage and Payment of Diabetes Self-Management Training Services and Medical Nutrition Therapy Services A-03-022
[sbull Installation of Version 29.0 of the ] Provider Statistical and Reimbursement Reporting System--Modification A-03-023 A-03-023
[sbull Implementation of the Temporary ] Equalization of Urban and Rural Standardized Payment Amounts Under the Medicare Inpatient Hospital Prospective Payment System as Required By Section 402(b) of Public Law 108-7 A-03-024
[sbull Advance Beneficiary Notices Must Be Given ] To Beneficiaries and Demands Bills Must Be Submitted By Home Health Agencies A-03-025
[sbull Advance Beneficiary Notices Must Be Given ] To Beneficiaries and Demands Bills Must Be Submitted By Home Health Agencies A-03-026
[sbull April Outpatient Code Editor Specifications ] Version (V4.1) A-03-027
[sbull Updated Outpatient Prospective Payment ] System: Requirements for Provider Education and Training A-03-028
[sbull January Medicare Outpatient Code Editor ] Specifications Version 18.1R1 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System A-03-029
[sbull Corrections to: Changes to the Hospital ] Inpatient Prospective Payment Systems and Rates and Costs of Graduate Medical Education, etc., as Published in the Federal Register, Fiscal Year 2003 (67 FR 49982, August 1, 2002) A-03-030
[sbull Provider-Based Status On or After October ] 1, 2002 A-03-031
[sbull Medicare Secondary Payer Information ] Collection Policies Changed for Hospitals A-03-032
[sbull Addition of Patient Status Code 43, ] Deletion of Patient Status Codes 71 and 72, and Information on New Patient Status Code 65 A-03-033
[sbull End-Stage Renal Disease Reimbursement for ] Automated Multi-Channel Chemistry Tests A-03-034
[sbull Modification to Medicare Timely Filing Edit ] for Claims Paid Under Certain Prospective Payment Systems A-03-035
[sbull Reporting of Revenue Codes Under the ] Outpatient Prospective Payment System A-03-036
[sbull Installation of Version 30.0 of the ] Provider Statistical and Reimbursement Reporting System--Modification A-03-037
[sbull Contractor Reporting of Operational and ] Workload Data for Electronic Data Interchange and Manual Transactions A-03-038
[sbull Program Integrity Management Reporting ] System for Part A Phase 2 A-03-039
[sbull Clarification to Corrections to Updated ] Instruction on Receipt and Processing of Non-Covered Changes on Other Than Part A Inpatient Claims (Transmittals A-02-071, A- 02-117)--Change In Effective and Implementation Date Only A-03-040
[sbull Clarification of Bill Types 22x and 23x ] Submitted by Skilled Nursing Facilities A-03-041
[sbull Health Insurance Portability and ] Accountability Act Version 4010A1 ...... Institutional 837 Health Care Claim Additional Implementation Direction A-03-042
[sbull Updated Revision to Change Request 2508, ] Suspension, Offset, and Recoupment of Medicare Payment to Providers and Suppliers of Services A-03-043
[sbull Changes to Fiscal Year 2001 Nursing and ] Allied Health Education Payment Policies A-03-044
[sbull Audit Guidance Pertaining To Write-Offs of ] Small Debit Balances in Patients' Accounts Receivable A-03-045
[sbull Payment to Hospitals and Units Excluded ] From the Acute Inpatient Prospective Payment System for Direct Graduate Medical Education and Nursing and Allied Health Education for Medicare+Choice Enrollees A-03-046
[sbull Demonstration--Settlement of Payment for ] Home Health Services to Beneficiaries Eligible for Both Medicare and Medicaid in Connecticut, and Massachusetts. Regional Home Health Intermediaries Only. A-03-047
[sbull Medicare's Coordination of Benefits ] Contractor Shall Discontinue the Dissemination of the Right of Recovery Letter to Intermediaries A-03-048
[sbull July Outpatient Code Editor Specifications ] Version (V4.2) A-03-049
[sbull Fiscal Intermediaries Must Install and Use ] Super Op With the Fiscal Intermediary Standard System A-03-050
[sbull July Medicare Outpatient Code Editor ] Specifications Version 18.2 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System A-03-051
[sbull July 2003 Update of the Hospital Outpatient ] Prospective System A-03-052
[sbull Revision to Billing for Swing-Bed Services ] Under the Skilled Nursing Facility Prospective Payment System
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A-03-053
[sbull Nurse Practitioner Services Under Medicare ] Hospice A-03-054
[sbull Revision to Change Request 2573, ] Transmittal A-03-013, dated February 14, 2003: 3-Day Payment Window Refinements Under the Short-Term Hospital Inpatient Prospective Payment System A-03-055
[sbull Disclosure of Information Requirements ] Related to Hospice Claims A-03-056
[sbull Payment Update for Long-Term Care Hospital ] Prospective Payment System Rate Year 2004
Program Memorandum Carriers (CMS Pub. 60B) (Superintendent of Documents No. HE 22.8/6-5)
B-03-023
[sbull Correct Payment of January and February ] 2003 Physician Services B-03-024
[sbull Follow-Up to Implementation of the National ] Council for Prescription Drug Programs Telecommunications Standard Version 5.1 and the Equivalents ...... Batch Standard Version 1.1 for Retail Pharmacy Drug Transactions B-03-025
[sbull Durable Medical Equipment Regional ] Carriers--DeWall Posture Protector Orthotic Body Jacket (L0430) B-03-026
[sbull Standard System Acceptance of Primary Payer ] Information at the Line Level B-03-027
[sbull Implementation of Carriers Jurisdiction ] Manual Instructions Based on the Medicare Carriers Manual Part 3, Section 3101 for the Multi-Carrier System ...... Standard System and Associated Medicare Carriers B-03-028
[sbull Durable Medical Equipment Regional ] Carriers--Internal Classification of Diseases--9--Classification of Diseases Coding B-03-029
[sbull Manager Care Reasonable Charge Data ] Disclosure Requirements for Ambulance Services B-03-030
[sbull Types of Services Corrections ] B-03-031
[sbull Multi-Carriers System Reporting of 2003 ] Participating Data to the Contractor ...... Reporting of Operational and Workload Data System B-03-032
[sbull Continuation of April and July 2003 Change ] Requests (2423 and 2524): Create Import/ Export Functionality Between the Unique Provider Identification Number System and the Provider Enrollment Chain Ownership System B-03-033
[sbull Continuation of April and July 2003 Change ] Requests (2425 and 2525): Create Import/ Export Functionality Between the Medicare Claims System and the Provider Enrollment Chain Ownership System B-03-034
[sbull Continuation of April and July 2003 Change ] Requests (2426 and 2526): Process All Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System. Modify the Medicare Claims System To Incorporate All Claim Payment and Provider Correspondence Functionality That Is Included in the Provider Enrollment System But Will Not Be a Part of Provider Enrollment Chain Ownership System B-03-035
[sbull Continuation of April and July 2003 Change ] Requests (2427 and 2527): Process All Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System. Create Import/Export Functionality Between the Viable Information Processing Systems Medicare System and Provider Enrollment Chain Ownership System B-03-036
[sbull Expansion of Beneficiary History and Claims ] In Process Files in the Viable Information Processing System Phase 1--Beneficiary History File Expansion B-03-037
[sbull Excluding From Home Health Consolidated ] Billing Edits Claims for Therapy Services Rendered by Physicians B-03-038
[sbull Oral Anti-Cancer Drugs ] B-03-039
[sbull Common Working File Skilled Nursing ] Facility Consolidated Billing Bypass To Allow Separate Payment for Drugs B-03-040
[sbull Update of the Place of Services Code Set ] B-03-041
[sbull National Council for Prescription Drug ] Program Batch Transaction Standard 1.1 Billing Request Companion Document B-03-042
[sbull Bi-Annual Updates to the Health Care ] Provider Taxonomy Code B-03-043
[sbull Diabetes Outpatient Self-Management ] Training and the ``Incident To'' Provision B-03-044
[sbull Correction to Business Requirements 2 ] B-03-045
[sbull International Classification of Diseases ] 9th Edition Clinical Modification Coding ...... Requirements for Claims Submitted to Medicare Carriers B-03-046
[sbull Provider Education: Establishing New ] Requirements for ICD-9-CM Coding on Claims Submitted to Medicare Carriers--Increased Role for Physicians/Practitioners B-03-047
[sbull Changes To Correct Coding Edits, Version ] 9.3, Effective October 1, 2003 B-03-048
[sbull Addition of Temporary Codes Q4052 and Q4053 ] B-03-049
[sbull Additional Instructions To Assist in the ] Implementation of Program Memorandum B-02- 075--Carrier Review of Payment Amounts for Portable X-Ray Transportation Services Health Care Procedure Coding System
Program Memorandum Intermediaries/Carriers (CMS Pub. 60A/B) (Superintendent of Documents No. HE 22.8/6-5)
AB-03-041
[sbull Common Working File Reject and Utilization ] Edits and Carriers Resolution for Consolidated Billing for Skilled Nursing Facility Residents AB-03-042
[sbull Coverage and Billing for Percutaneous Image- ] Guided Breast Biopsy AB-03-043
[sbull Addition of ``K'' Codes for Surgical ] Dressings AB-03-044
[sbull Addition of Temporary ``K'' Codes ] AB-03-045
[sbull Addition of Temporary ``K'' Codes ] AB-03-046
[sbull Expanding the Number of Source Identifiers ] for Common Working File Medicare Secondary Payor AB-03-047
[sbull Single Drug Pricer Clarifications ] AB-03-048
[sbull End-Stage Renal Disease Coordination Period ] AB-03-049
[sbull Clarification of Payment Responsibilities ] of Fee-for-Service Contractors as They Relate to Hospice Members Enrolled in Managed Care Organizations and Claims Processing Instructions for Processing Rejected Claims
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AB-03-050
[sbull Data Center Testing and Production-- ] Electronic Correspondence Referral System User Manual 5.1 and Quick Reference Guide Replacement AB-03-051
[sbull Notice of Interest Rate for Medicare ] Overpayments and Underpayments AB-03-052
[sbull Managing Medicare Appeals Workloads in ] Fiscal Year 2003 AB-03-053
[sbull Availability of Online Screens for the ] Laboratory National Coverage Determinations AB-03-054
[sbull Diagnosis Code for Screening Pap Smear and ] Pelvic Examination Services AB-03-055
[sbull Shared System Maintainer Hours for ] Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing AB-03-056
[sbull New Waived Test--March 21, 2003 ] AB-03-057
[sbull Implementation of the Financial Limitation ] for Outpatient Rehabilitation Services AB-03-058
[sbull Collection of Fee-for-Service Payments Made ] During Periods of Managed Care Enrollment AB-03-059
[sbull Shared Systems Changes for Name Change From ] Health Care Financing Administration to Centers for Medicare & Medicaid Services (Fiscal Intermediary Standard and VIPS Medicare System External Changes Only) AB-03-060
[sbull Flat File Changes in the Health Care Claim ] Professional (837 Professional) Version 4010A1, Health Care Claim Payment/Advice (835) Version 4010 and 4010A1 and 3051.4A, and Health Care Claim Status Inquiry and Response (276/277) Version 4010A1 Transactions AB-03-061
[sbull Program Memorandum on Written Statements of ] Intent To Claim Medicare Benefits AB-03-062
[sbull New Common Working File Edits and Standard ] System Responses on Skilled Nursing Facility Claims AB-03-063
[sbull New Common Working File Medicare Secondary ] Payer Edit to Reject Medicare Secondary Edit Records for Medicare Beneficiaries Who Are Only Entitled To Medicare Part B, and Are Covered by a Group Health Plan AB-03-064
[sbull System Networking Electronic Correspondence ] Referral System User Guide AB-03-065
[sbull Schedule Release for July Updates to ] Software Programs and Pricing/Coding Files AB-03-066
[sbull Issuance of the Eligibility File-Based ] Standard Trading Partner Agreement for the Purpose of Coordination of Benefits AB-03-067
[sbull Revision to Change Request 2170: Appeals ] Quality Improvement and Data Analysis Activities AB-03-068
[sbull Common Working File Change for the 270/271 ] Eligibility Transaction AB-03-069
[sbull Clarification of the Criteria for a Valid ] Written Statement of Intent To File a Medicare Claim AB-03-070
[sbull Second Update to the 2003 Medicare ] Physician Fee Schedule Database AB-03-071
[sbull July Quarterly Update for 2003 Durable ] Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule AB-03-072
[sbull Mammography Computer-Aided Detection ] Equipment AB-03-073
[sbull Provider Education Article: Financial ] Limitation of Claims for Outpatient Rehabilitation Services AB-03-074
[sbull Instructions for Fiscal Intermediary ] Standard System and Multi-Carrier System Healthcare Integrated General Ledger Accounting System Changes AB-03-075
[sbull Provider Education Article: Quarterly ] Provider Update AB-03-076
[sbull Remittance Advice Message for Denial of ] Clinical Diagnostic Laboratory Services Denied Due to Frequency Edits AB-03-077
[sbull Revised Disclosure Desk Reference for Call ] Centers AB-03-078
[sbull Medicare Fee-for-Service Contractor ] Guidance of the Health Insurance Portability and Accountability Act Privacy Rule Business Associate Provisions AB-03-079
[sbull Claims Processing Instructions for the Utah ] Graduate Medical Education Demonstration AB-03-080
[sbull Single Drug Pricer Clarification for Code ] J7342 AB-03-081
[sbull Data Center Testing and Production-- ] Electronic Correspondence Referral System User Manual 6.0 AB-03-082
[sbull Medicare Secondary Payer Prepayment and ] Postpayment Workload Reporting--Activity Code Definitions AB-03-083
[sbull Screening of Complaints Alleging Fraud and ] Abuse AB-03-084
[sbull Changes to the Laboratory National Coverage ] Determination Edit Software for July 1, 2003 AB-03-085
[sbull Beneficiary Notice of Implementation of ] Outpatient Therapy Service Limitations AB-03-086
[sbull New Automatic Notice of Change to Medicare ] Secondary Payer Auxiliary File AB-03-087
[sbull Common Working File Edits With Unsolicited ] Responses for Skilled Nursing Facility Consolidated Billing AB-03-088
[sbull Prohibition on New Trading Partner ] Agreements With Certain Entities for the Purpose of Coordination of Benefits AB-03-089
[sbull Coverage and Billing for Home Prothrombin ] Time International Normalized Ratio Monitoring for Anticoagulation Management AB-03-090
[sbull Coverage of Compression Garments in the ] Treatment of Venous Stasis Ulcers AB-03-091
[sbull Medicare Contractor Annual Update of the ] International Classification of Diseases, Ninth Revision, Clinical Modification AB-03-092
[sbull Expanded Coverage of Positron Emission ] Tomography Scans and Related Claims Processing Requirements for Thyroid Cancer and Perfusion of the Heart Using Ammonia N- 13 AB-03-093
[sbull Correction: Coverage and Billing ] Requirements for Electrical Stimulation for the Treatment of Wounds
Hospice Manual (CMS Pub. 10) (Superintendent of Documents No. HE 22.8/2)
800
[sbull Screening Pap Smears and Screening Pelvic ] Examinations 801
[sbull Notice to Beneficiaries ] ...... Peer Review Organization Monitoring of Hospital Admission Notice to Beneficiaries 802
[sbull Frequency of Billing ] 803
[sbull Magnetic Resonance Angiography ] 804
[sbull Screening Pap Smears and Screening Pelvic ] Examinations 805
[sbull International Classification of Diseases ] 9th Edition Clinical Modification
[[Page 55625]]
Home Health Agency Manual (CMS Pub. 11) (Superintendent of Documents No. HE 22.8/5)
304
[sbull Frequency of Billing ]
Coverage Issues Manual (CMS Pub. 6) (Superintendent of Documents No. HE 22.8/14)
169
[sbull Stem Cell Transplantation ] 170
[sbull Magnetic Resonance Angiography ] 171
[sbull Positron Emission Tomography Scans ] 172
[sbull Intestinal and Multi-Visceral ] Transplantation
Peer Review Organization (CMS Pub. 19) (Superintendent of Documents No. 22.8/8-15)
90
[sbull Eligibility--has been moved to the Pub. 100- ] 10, Medicare Quality Improvement Organizations Manual, Chapter 2, which can be found at http://www.cms.hhs.gov/ manuals. ...... Data Management--has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 8, which can be found at http://www.cms.hhs.gov/ manuals. ...... Management--has been moved to the Pub. 100- 10, Medicare Quality Improvement Organizations Manual, Chapter 13, which can be found at http://www.cms.hhs.gov/ manuals. ...... Performance Evaluation--has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 15, which can be found at http://www.cms.hhs.gov/manuals .
Hospice Manual (CMS Pub. 21) (Superintendent of Documents No. HE 22. 8/18)
67
[sbull Frequency of Billing ]
Rural Health Clinic Manual & Federally Qualified Health Centers Manual (CMS Pub. 27) (Superintendent of Documents No. He 22. 8/19:985)
38
[sbull Magnetic Resonance Angiography ]
Rural Dialysis Facility Manual (Non-Hospital Operated) (CMS Pub. 29) (Superintendent of Documents No. 22.8/13)
95
[sbull Frequency of Billing ]
Provider Cost Reporting Forms and Instructions Provider Reimbursement Manual--Part 2
Chapter 36/Form CMS-2552-96 (CMS Pub. 15-2-36) (Superintendent of Documents No. HE 22.8/4)
10
[sbull Hospital Healthcare Complex Cost Report ]
Program Integrity Manual (CMS Pub. 100-08)
40
[sbull Local Provider Education and Training ] Program 41
[sbull Definitions Related To Enrollment ] ...... Benefit Integrity/Payment Safeguard Contractor vs. Provider Enrollment Contractors ...... Forms Disposition ...... Processing the Application ...... Identification ...... Adverse Legal Actions ...... Practice Location ...... Ownership and Managing Control Information (Organizations) ...... Ownership and Managing Control Information (Individuals) ...... Delegated Official ...... Ambulance Services Suppliers ...... Certified Basic Life Support ...... Independent Diagnostic Testing Facilities-- Attachment 1 ...... Entities That Must Enroll as Independent Diagnostic Testing Facilities
[[Page 55626]]
...... Review of Attachment 2, Independent Diagnostic Testing Facility ...... Enrollment Checks ...... Special Consideration ...... Reassignment of Benefits--Form CMS-855R ...... Reassignment of Benefits Statement ...... Attestation Statement ...... Enrolling Certified Suppliers Who Enroll With Carrier ...... Managed Care Organization ...... Application Sectional Instructions for Intermediaries ...... Processing the Application ...... Provider Identification ...... Adverse Legal Actions ...... Practice Location ...... Ownership and Managing Control Information (Organizations) ...... Chain Home Office Information ...... Billing Agency ...... Staffing Company ...... Capitalization Requirements for Home Health Agencies ...... Contact Person ...... Certification Statement ...... Delegated Official ...... Special Processing Situation ...... Community Mental Health Centers ...... Benefit Improvement and Protection Act of 2000 Provisions ...... Community Mental Health Centers Enrollment and Change of Ownership ...... Site Visit ...... Process ...... Deactivation of Billing Numbers for Inactive Community Mental Health Centers ...... State Survey Regional Office Process ...... Changes of Information--New Form CMS-855 Data ...... Change Requirement ...... Procedures for Request for Additional Information, Approval, Denial or Transmission of Recommendations ...... Request for Additional Information ...... Approval and Recommendations for Approval ...... Denials ...... Failure to Sign and/or Date the Application ...... Revocations ...... Time Frame for Application Processing ...... Matrix ...... Verification and Validation of Information ...... Fraud Investigation Database ...... Healthcare Integrity and Protection Data Bank ...... Excluded Parties List System ...... Enrollment of Hospitals, Assignment of Billing Numbers ...... Provider-Based Processing and Changes in Status ...... Web Site ...... File Maintenance and Review 42
[sbull Effectuating Favorable Final Appellate ] Decisions That a Beneficiary Is Confined To Home 43
[sbull Medical Records Information Reported ] Electronically ...... Electronic Media Claim Flat File Record for End-Stage Renal Disease ...... Argus Filed Descriptions and Formats
Managed Care Manual (Pub. 100-16)
23
[sbull Introduction ] ...... General Requirements ...... Basic Rule ...... Services of Noncontracting Providers and Suppliers ...... Types of Benefits ...... Availability and Structure of Plans ...... Terms of Medicare+Choice Plans ...... Multiple Plans in One Service Area ...... Centers for Medicare & Medicaid Services Review and Approval of Medicare+Choice Benefits ...... Requirements Relating To Medicare Conditions of Participation ...... Provider Networks ...... Requirements Relating To Benefits ...... Basic Benefits ...... Additional Benefits ...... Supplemental Benefits--Mandatory Supplemental and Optional Supplemental
[[Page 55627]]
...... Basic Versus Supplemental Benefits ...... Medicare Covered Benefits ...... Medicare+Choice Medical Savings Account Plan Benefits ...... General Rule ...... Countable Expenses ...... Services After the Deductible ...... Balance Billing ...... The Annual Deductible ...... Special Rules on Supplemental Benefits for Medicare+Choice Medical Savings Account Plans ...... Point of Service Option ...... General Rule ...... Accessing Plan Contracting Providers ...... Financial Cap ...... Enrollee Information and Disclosure ...... Prompt Payment ...... Point of Services Related Data ...... Services Area ...... Definition ...... Factors That Influence Service Area Approvals ...... The ``County Integrity Rule'' ...... Coordination of Benefits With Employer Group Health Plans and Medicaid ...... General Rule ...... Requirements, Rights, and Beneficiary Protection ...... Medicare Secondary Payer Procedures ...... Basic Rule ...... Responsibilities of the Medicare+Choice Organization ...... Medicare Benefits Secondary to Group Health Plans and Large Group Health Plans ...... Collecting From Other Entities ...... Collecting From Other Insurers or the Enrollee ...... Collecting From Group Health Plans and Large Group Health Plans ...... Medicare Secondary Payor ...... National Coverage Determinations and Legislative Changes in Benefits ...... Definitions ...... General Rules ...... Sources for Obtaining Information ...... Discrimination Against Beneficiaries Prohibited ...... General Prohibition ...... Additional Requirements ...... A Medicare+Choice Organization's Responsibility ...... Disclosure Requirements ...... Introduction ...... Disclosure Requirements at Enrollment (and Annually Thereafter) ...... Disclosure Upon Request ...... Information Pertaining to a Medicare+Choice Organization Changing Its Rules or Provider Network ...... Other Information That Is Disclosable ...... Access to (and Availability of ) Service ...... Introduction ...... Access and Availability Rule for Coordinated Care Plans ...... Rules for All Medicare+Choice Organizations to Ensure Continuity of Care ...... Ambulance, Emergency, and Urgently Needed, and Post-Stabilization Care Services Ambulance ...... Emergency and Urgently Needed Services ...... Post-Stabilization Care Services ...... Confidentiality and Accuracy of Enrollee Records ...... General Rule ...... Private Fee-for-Service Plans ...... Information on Advance Directives ...... Definition Basic Rule State Law Primary Content of Enrollee Information and Other Medicare+Choice Obligations Incapacitated Enrollees Community Education Requirements Medicare+Choice Organization Rights Appeal and Anti-Discrimination Rights
[[Page 55628]]
24
[sbull Introduction ] Provider Involvement in Policy-Making Physician Consultation in Medical Policies Consultation in Development of Credentialing Policies Written Information on Physician Participation Interference With Health Care Professionals' Advice to Enrollees Prohibited Provider Anti-Discrimination Provider Participation Notice of Reason for Not Granting Participation Confirmation of Eligibility for Participation in Medicare Excluded and Outpatient Physical Therapy and Opt-Out Provider Checks Credentialing, Monitoring, and Recredentialing Suspension, Termination, or Nonrenewal of Physician Contract Institutional Provider and Supplier Certification Physician Incentive Plans Requirements and Limitations Disclosure of Physician Incentive Plans Provider Indemnification of Medicare+Choice Organization Prohibited Special Rules for Services Furnished by Non- Contract Provider 25
[sbull Introduction ] Terminology Rules Governing Premiums and Cost Sharing Monthly Premiums Uniformity of Premiums Segmented Services Area Option ...... Timing of Payments Monetary Inducements Prohibited Submission of Proposed Premiums and Related Information General Rule Information Required for Coordinated Care Plans and Private Fee-For-Service Plans Average Payment Rate Centers for Medicare & Medicaid Services Review Limits on Premiums and Cost-Sharing Amounts Rules for Coordinated Care Plans Rules for Medicare+Choice Private Fee-for- Service Plans Special Rules for Mid-Year (Benefit) Enhancement General Rule Incorrect Collections of Premiums and Cost Sharing Definitions Refund Methods Reduction by Centers for Medicare & Medicaid Services Adjusted Community Rate Process General Information Standard Method Initial Rate Calculation Initial Rate Adjustment by Medicare+Choice Organization Initial Rate Adjustment by Centers for Medicare & Medicaid Services Other Methods for Computing Adjusted Community Rate Special Rule for Centers for Medicare & Medicaid Services Average Payment Rate or Adjusted Community Rate Calculation Centers for Medicare and Medicaid Services Review Sufficiency of Documentation and Periodic Audits Requirement for Additional Benefits--42 Code of Federal Regulations 422.312 Definitions General Information Stabilization Fund Establishment of a Stabilization Fund Limit Per Contract Period Exception to the Limit Per Contract Period Cumulative Limit Interest on and Accounting of Reserved Funds Withdrawal From a Stabilization Fund Criteria for Centers for Medicare & Medicaid Services Approval ...... Basis for Denial ...... Form of Payment ...... Additional Benefits ...... Part B Premium Reduction As an Additional Benefit ...... Additional Health Care Benefits ...... Reduction of Charges to Enrollees for Basic Benefits ...... Additional Supplemental Health Care Benefits and Related Premiums
[[Page 55629]]
...... Detailed Instructions ...... Enrollees Who Elect Hospice While Remaining Enrolled in a Medicare+Choice Plan ...... Hospice Benefits ...... Medicare+Choice Non-Medicare-Covered Benefits ...... Medicare+Choice Medicare-Covered Benefits (Except Hospice) ...... Medicare+Choice Non-Medicare-Covered Benefits ...... Enrollees with End-Stage Renal Stage Disease User Fees ...... End-Stage Renal Disease Network Fee ...... Information Campaign User Fee ...... Waivers for Medicare+Choice Organization Contracts With Employer or Union Groups ...... Background ...... Section 617 Waiver Categories Approved ...... Service Areas ...... Adjusted Community Rate Filings ...... Coordination of Benefits ...... Effect on Medicare+Choice Plan Cash Flow ...... Effect on Adjusted Community Rate Calculations
Addendum IV.--Regulation Documents Published in the Federal Register [April 2003 Through June 2003]
FR vol. 68 Publication date
page No. CFR parts affected File code
Title of regulation
April 2, 2003............
15973 42 CFR Part 440... CMS-2132-P........ Medicaid Program; Provider Qualifications for Audiologists. April 4, 2003............
16652 42 CFR Parts 422 CMS-4024-FC....... Medicare Program; Improvements and 489.
to the Medicare+Choice Appeal and Grievance Procedures. April 16, 2003...........
18654
CMS-1256-N........ Medicare Program; Notice of Ambulance Fee Schedule in Accordance With Federal District Court Order. April 17, 2003...........
18895 45 CFR Part 160... CMS-0010-IFC...... Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings. April 25, 2003...........
22268 42 CFR Parts 405, CMS-1203-CN....... Medicare Program; Changes to the 412, 413, and 485.
Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates; Correction. April 25, 2003...........
22064 42 CFR Parts 420, CMS-6002-P........ Medicare Program; Requirements 424, 489, and 498.
for Establishing and Maintaining Medicare Billing Privileges. April 25, 2003...........
20394 .................. CMS-1251-N........ Medicare Program; Meeting of the Practicing Physicians Advisory Council--May 19, 2003. April 25, 2003...........
20393 .................. CMS-4052-N........ Medicare Program: Meeting of the Advisory Panel on Medicare Education--May 21, 2003. April 25, 2003...........
20391 .................. CMS-2182-PN....... Medicare and Medicaid Programs; Application by the Community Health Accreditation Program (CHAP) for Continued Approval of Deeming Authority for Hospices. April 25, 2003...........
20349 42 CFR Parts 422 CMS-4024-CN....... Medicare Program; Improvements and 489.
to the Medicare+Choice Appeal and Grievance Procedures; Correction. April 25, 2003...........
20347 42 CFR Part 411... CMS-1809-F3....... Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date. April 28, 2003...........
22453 45 CFR Part 160... CMS-0010-IFC (OFR) Civil Money Penalties: Correction).
Procedures for Investigations, Imposition of Penalties, and Hearings; Correction. May 2, 2003..............
23410 45 CFR Part 148... CMS-2179-FC....... Grants to States for Operation of Qualified High Risk Pools. May 16, 2003.............
26786 42 CFR Part 412... CMS-1474-P........ Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for FY 2004. May 16, 2003.............
26758 42 CFR Parts 409, CMS-1469-P........ Medicare Program; Prospective 413, 440, and 483.
Payment System and Consolidated Billing for Skilled Nursing Facilities--Update. May 16, 2003.............
26621 .................. CMS-4060-N........ Medicare Program; Town Hall Meeting on the Refinement of the Minimum Data Set (MDS), Version 3.0. May 19, 2003.............
27154 42 CFR Parts 412 CMS-1470-P........ Medicare Program; Proposed and 413.
Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates. May 29, 2003.............
32053 .................. CMS-2185-N........ Fiscal Year 2003 Program Announcement; Availability of Funds and Notice Regarding Applications. May 30, 2003.............
32528 .................. CMS-2177-FN....... Medicare and Medicaid Programs; Approval of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Deeming Authority for Hospices. May 30, 2003.............
32527 .................. CMS-3116-N........ Medicare Program; Request for Nominations for Members for the Medicare Coverage Advisory Committee.
[[Page 55630]]
May 30, 2003.............
32406 42 CFR Part 416... CMS-1885-CN....... Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003. May 30, 2003.............
32400 42 CFR Parts 410, CMS-1204-CN....... Medicare Program; Revisions to 414, and 485.
Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 and Inclusion of Registered Nurses in the Personnel Provision of the Critical Access Hospital Emergency Services Requirement for Frontier Areas and Remote Locations. June 4, 2003.............
33579 42 CFR Parts 412 CMS-1470-P (OFR Medicare Program; Proposed and 413.
Correction).
Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates. June 4, 2003.............
33495 .................. CMS-5003-N........ Medicare Program; Demonstration: End-Stage Renal Disease-- Disease Management. June 6, 2003.............
34122 42 CFR Part 412... CMS-1472-F........ Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes. June 9, 2003.............
34494 42 CFR Part 412... CMS-1243-F........ Medicare Program; Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment Systems. June 9, 2003.............
34492 42 CFR Parts 412 CMS-1470-P (OFR Medicare Program; Proposed and 413.
Correction).
Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates; Correction. June 10, 2003............
34768 42 CFR Part 413... CMS-1469-P2....... Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--Update. June 27, 2003............
38370 .................. CMS-1259-N........ Medicare Program; Public Meeting in Calendar Year 2003 for New Clinical Laboratory Tests Payment Determinations. June 27, 2003............
38370 .................. CMS-5003-N2....... Medicare Program; Extension of Date of Submissions and Informational Meeting on the Application Process for the End- Stage Renal Disease--Disease Management Demonstration. June 27, 2003............
38359 .................. CMS-9017-N........ Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January 2003 Through March 2003. June 27, 2003............
38346 .................. CMS-4062-N........ Medicare and Medicaid Programs; Solicitation for Information on the Hospital CAHPS. June 27, 2003............
38345 .................. CMS-1257-N........ Medicare Program: Notice of the Practicing Physicians Advisory Council Rechartering. June 27, 2003............
38269 .................. CMS-6012-N6....... Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics; Meeting Announcement. June 27, 2003............
38206 45 CFR Part 146... CMS-2152-F........ Amendment to the Interim Final Regulation for Mental Health Parity.
Addendum V.--National Coverage Determinations, April 2003 Through June 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 became effective during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce impending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by section of the Coverage Issues Manual (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 [April 2003 Through June 2003]
CIM section
Title
Issue date Effective date
Coverage Issues Manual (CIM) (CMS Pub. 06)
50-14............................ Magnetic Resonance Angiography of the Abdomen
05/09/03
07/01/03 and Pelvis. 35.85.1.......................... Implantable Automatic Defibrillators.........
06/06/03
10/01/03 50-36............................ PET for Thyroid Cancer.......................
06/20/03
10/01/03 50-36............................ PET for Soft Tissue Sarcoma..................
06/20/03
10/01/03 50-36............................ PET for Alzheimer's Disease/Dementia.........
06/20/03
10/01/03
[[Page 55631]]
50-36............................ PET for Myocardial Perfusion of the Heart
06/20/03
10/01/03 Using Ammonia N-13.
PM No.
Title
Issue date Effective date Program Memorandum (PM)
AB-03-084........................ Changes to the Laboratory NCD Edit Software
06/06/03
07/01/03 For 07/03 (Blood Counts, Blood Glucose Testing, HIV Testing).
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, April through June 2003.
Investigational Device Exemption Numbers, 2nd Quarter 2003
IDE
Category
G010175.....................................................
B G010354.....................................................
B G020083.....................................................
B G020115.....................................................
A G020230.....................................................
B G020231.....................................................
B G020244.....................................................
B G020273.....................................................
B G020307.....................................................
B G020319.....................................................
B G020323.....................................................
B G030001.....................................................
B G030007.....................................................
B G030034.....................................................
B G030044.....................................................
B G030045.....................................................
B G030051.....................................................
B G030054.....................................................
B G030055.....................................................
B G030056.....................................................
B G030058.....................................................
B G030061.....................................................
B G030062.....................................................
B G030063.....................................................
B G030064.....................................................
B G030065.....................................................
B G030073.....................................................
B G030074.....................................................
B G030075.....................................................
B G030078.....................................................
B G030080.....................................................
B G030082.....................................................
B G030088.....................................................
B G030089.....................................................
B G030090.....................................................
B G030091.....................................................
B G030095.....................................................
B G030096.....................................................
B G030097.....................................................
B G030101.....................................................
B G030103.....................................................
B G030104.....................................................
B G030105.....................................................
A G030106.....................................................
B G030108.....................................................
B G030109.....................................................
B G030110.....................................................
B G030113.....................................................
B G030114.....................................................
B G030115.....................................................
B G030117.....................................................
B G030118.....................................................
B G030120.....................................................
B G030122.....................................................
B G030124.....................................................
B G030126.....................................................
B G030128.....................................................
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. 0938-0034.................. 405.821. 0938-0035.................. 407.4. 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, 440.250, 440.220, 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 and 455.100-455.106.
[[Page 55632]]
0938-0101.................. 430.3. 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.................. 405.247. 0938-0170.................. 493.1269-493.1285. 0938-0193.................. 430.10-430.20 and 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. 0938-0251.................. 406.7. 0938-0266.................. 416.41, 416.83, 416.47, 416.48. 0938-0267.................. 485.56, 485.58, 485.60, 485.64, 485.66, 410.65. 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.................. 413.17. 0938-0300.................. 431.8. 0938-0301.................. 413.20, 413.24. 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 Subpart A. 0938-0338.................. 486.104, 486.106, 486.110. 0938-0354.................. 441.6. 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 and 489.21. 0938-0358.................. 412.20-412.30. 0938-0359.................. 412.40-412.52. 0938-0360.................. 405.2100-405.2184. 0938-0365.................. 484.10, .11, .12, .14, .16, .18, .20, .36, .48, .52. 0938-0372.................. 414.33. 0938-0378.................. 482.60-482.62. 0938-0379.................. 418.1-418.405. 0938-0380.................. 482.1-482.66. 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.................. 424.2. 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 and 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.................. 475.100 Subpart C, 475.106 and 475.107, 462.102, 462.103. 0938-0534.................. 410.38, 424.5. 0938-0544.................. 493.1-493.2001. 0938-0565.................. 411.20-411.206. 0938-0566.................. 411.404(b)(c), 411.406(d), 411.408(d)(2) and (f). 0938-0567.................. Part 498 Subpart H, Part 498 Subparts D and E, and 20 CFR 404.933. 0938-0573.................. 412.256 and 412.230. 0938-0581.................. 493.1-493.2001. 0938-0599.................. 493.1-493.2001. 0938-0600.................. 405.371, 405.378 and 413.20.
[[Page 55633]]
0938-0610.................. 417.436, 417.801, 417.436(d), 422.128, 430.12(c)(1)(ii), 431.20, 31.107, 434.28, 483.10, 484.10(c)(ii), 489.102. 0938-0612.................. 493.1-493.2001. 0938-0618.................. 433.68, 433.74, 447.272. 0938-0653.................. 493. 0938-0655.................. 493.184. 0938-0657.................. 405.2110, 405.2112. 0938-0658.................. 405.2110, 405.2112. 0938-0667.................. 482.12, 488.18, 489.20 and 489.24. 0938-0673.................. 430.1. 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, and 489.27. 0938-0700.................. 417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103 & 1003.106. 0938-0701.................. 422.152. 0938-0702.................. 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180. 0938-0703.................. 45 CFR 148.120, 148.124, 148.126, and 148.128. 0938-0714.................. 411.370-411.389. 0938-0717.................. 424.57. 0938-0721.................. 410.33. 0938-0722.................. 422.370-422.378. 0938-0723.................. 421.300-421.318. 0938-0730.................. 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24. 0938-0732.................. 417.126, 417.470. 0938-0734.................. 45 CFR 5b. 0938-0739.................. 413.337, 413.343, 424.32, 483.20. 0938-0742.................. 422.300-422.312. 0938-0749.................. 424.57. 0938-0753.................. 422.000-422.700. 0938-0754.................. 441.152. 0938-0758.................. 413.20, 413.24. 0938-0760.................. Part 484 Subpart E, 484.55. 0938-0761.................. 484.11, 484.20. 0938-0763.................. 422.1-422.10, 422.50-422.80, 422.100- 422.132, 422.300-422.312, 422.400-422.404, and 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.................. 417.470, 417.126(a), 422.210(h), 422.64(10). 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.................. 413.65, 419.42. 0938-0802.................. 419.43. 0938-0810.................. 482.45. 0938-0819.................. 45 CFR 146.121. 0938-0823.................. 420.41. 0938-0824.................. 482.13(f)(7), 440.10(1)(3)(iii). 0938-0827.................. 45 CFR 146.141. 0938-0829.................. 422.568. 0938-0832.................. 489. 0938-0833.................. 483.350-483.376. 0938-0840.................. 422.152(b)(2). 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, and 457.1180. 0938-0842.................. 412 and 413. 0938-0846.................. 411.1, 411.350-411.357 and 424.22. 0938-0857.................. 419. 0938-0860.................. 419. 0938-0866.................. 45 CFR Part 162. 0938-0872.................. 483.20, 413.337. 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.
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0938-0897.................. 412.22, 412.533.
[FR Doc. 03-24069 Filed 9-25-03; 8:45 am]
BILLING CODE 4120-03-P
