Medicare and Medicaid: Program issuances and coverage decisions; quarterly listing,
[Federal Register: June 25, 2004 (Volume 69, Number 122)]
[Notices]
[Page 35634-35650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn04-92]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9022-N]
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January 2004 Through March 2004
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 January 2004 through March 2004, 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 (IDE) numbers approved by the Food and Drug Administration (FDA) 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
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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 Medicare National Coverage Determinations (NCDs) 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 FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to Eileen Davidson, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, S3-26- 10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6874.
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 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:
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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 National Coverage Determination Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634).
To aid the reader, we have organized and divided this current listing into six addenda:
Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.
Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the--
--Date published; --Federal Register citation; --Parts of the Code of Federal Regulations (CFR) that have changed (if applicable); --Agency file code number; and --Title of the regulation
Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.
Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.
Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.
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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
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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' Compact Disk-Read Only Memory (CD-ROM)
Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:
Titles XI, XVIII, and XIX of the Act.
CMS-related regulations.
CMS manuals and monthly revisions.
CMS program memoranda.
The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at http://www.ssa.gov/OP_Home/ssact/comp-toc.htm. ) The remaining portions of CD-ROM are updated on a
monthly basis.
Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re- visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.
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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.
For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare Benefit Policy publication titled ``Restoring Composite Rate Exceptions for Pediatric Facilities Under the End-Stage Renal Disease Composite Rate System,'' use CMS-Pub. 100-02, Transmittal No. 07.
(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: June 14, 2004. 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.
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 (68 FR 55618) December 24, 2003 (68 FR 74590) March 26, 2004 (69 FR 15837)
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.
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Addendum III--Medicare and Medicaid Manual Instructions [January 2004 Through March 2004]
Transmittal No.
Manual/Subject/Publication No.
Medicare General Information (CMS-Pub. 10001)
02
Scheduled Release for April Updates to Software and Pricing/Codes Files 03
New Part B Annual Deductible
Medicare Benefit Policy (CMS-Pub. 10002)
07
Restoring Composite Rate Exceptions for Pediatric Facilities Under the End-Stage Renal Disease Composite Rate System 08
Policy Changes to Reflect Billing for Darbepoetin Alfa and Epoetin
Medicare National Coverage Determinations (CMS-Pub. 10003)
07
Electrical Stimulation and Electromagnetic Therapy for the Treatment of Wounds 08
Current Perception Threshold/Sensory Nerve Conduction Threshold Test 09
Cardiac Output Monitoring by Thoracic Electrical Bioimpendance
Medicare Claims Processing (CMS-Pub. 10004)
60
Manualization of 2632, New Computer-Aided Detection Codes for Screening and Diagnostic Digital Mammography Services Health Common Procedure Coding System and Diagnosis Codes for Mammography Services Computer-Aided Detection Addon Codes Computer-Aided Detection Billing Charts Outpatient Hospital Mammography Payment Table Payment for Computer Add-on Diagnostic and Screening Mammograms for Fiscal Intermediary and Carriers Critical Access Hospital Payment Critical Access Hospital Mammography Payment Table Skilled Nursing Facility Mammography Payment Table Rural Health Claim/Federally Qualified Health Center Claims with Dates of Service on or After January 1, 2002 Fiscal Intermediary Data for Common Working File and the Provider Statistical and Reimbursement Report Carrier Processing Requirements Part B Carrier Claim Record for Common Working File Carrier and Common Working File Edits Mammograms Performed with New Technologies 61
Revises Diagnosis Coding Instructions for Requests for Anticipated Payment and Claims to Conform with Health Insurance Portability and Accountability Act of 1996 Requirements 62
Correction to January 2004 Annual Update of Health Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement 63
Special Rules for Critical Access Hospital Outpatient Billing 64
Coding Change for Ventricular Assist Devices for Beneficiaries in a Medicare+Choice Plan 65
ANSI X12 Transaction 835 Companion Document Change for Carriers, Durable Medical Equipment Regional Carriers, and Intermediaries 66
Quarterly Update to Correct Coding Initiative Edits, Version 10.1, Effective April 1, 2004 67
Revision to Change Request 2912: Coding, Testing, and Implementation Phases of Change Request 2631 for Jurisdiction 68
New Requirements for Critical Access Hospitals. These Changes Have Been Established with the Medicare Prescription Drug Improvement, and Modernization Act of 2003, PL 108173 69
Criteria for Using the CB Modifier 70
Implementation of the Annual Desk Review Program for Hospital Wage Data: Cost Reporting Periods Beginning On or After October 1, 2000, Through September 30, 2001 (Fiscal Year 2005 Wage Index) 71
Changes to the Laboratory National Coverage Determination Edit Software for April 2004 72
Update of Address for the Railroad Retirement Board 73
Medicare Code Editor and IPPS Transfers between Hospitals 74
Intravenous Immune Globulin 75
Medicare Modernization Act Pricing File Clarifications 76
Manualization of Skilled Nursing Facilities Inpatient Part A Billing Services Included in Part A PPS Payment Not Billable Separately by the Skilled Nursing Facility Services Beyond the Scope of the Part A Skilled Nursing Facility Benefit Carrier Claims Processing for Consolidated Billing for Physician and Non-Physician Practitioner Services Rendered to Beneficiaries in a Part A Skilled Nursing Facility Stay Correct Place of Service Code for Skilled Nursing Facility Claims Common Working File Edits Reject and Unsolicited Response Edits Utilization Edits Duplicate Edits Edit for Ambulance Services Edit for Clinical Social Workers Common Working File Override Codes Coding Files and Updates
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Annual Update Process Beneficiaries in a Part A Covered Stay Carrier Claims Processing for Consolidated Billing for Physician and Physician Practitioner Services Rendered to Beneficiaries in a NonCovered Skilled Nursing Facility Stay 77
Change in Methodology for Determining Payment for Outliers Outlier Payments: CosttoCharge Ratios 78
Update to Medicare Secondary Payment Module to Apportion Prospective Payment System Outlier Amounts to All Service and APC Lines That are Pricer Related Billing and Payment in a Health Professional Shortage Area 79
End Stage Renal Disease Reimbursement for Automated MultiChannel Chemistry Test(s) 80
Extend Medicare Coverage for Certain Colorectal Cancer Screenings at Skilled Nursing Facility Billing Requirements for Claims Submitted to Intermediaries 81
Report Of Admission Date and Additional Edit Requirements for the X12N 837 Coordination of Benefits Transaction Form Locator 2 Untitled 82
EndStage Renal Disease Data for Use In Adjudicating Claims Utilization of REMIS for Carrier Claims Adjudication 83
New ``K'' Codes for Wheelchair Cushions 84
Additional Guidelines for Implementing the National Council for Prescription Drug Program National Council for Prescription Drug Program Implementation 85
Payment of Skilled Nursing Facility Claims for Beneficiaries Disenrolling From Terminating Medicare+Choice Definitions Laboratories Billing for Referred Tests Claims Information and Claims Forms and Formats Paper Claim Submission to Carriers Electronic Claim Submission to Carriers Referring Laboratories Reporting of Pricing Localities for Clinical Laboratory Services Jurisdiction of Referral Laboratory Services Examples of Reference Laboratory Jurisdiction Rules 86
X12N 837 Professional Implementation Guide Edits 87
Coverage and Billing for Home Prothrombin Time International Normalized Ratio Anticoagulation Management IPPS Transfers Between Hospitals 88
Implementation of Section 414 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 General Coverage and Payment Policies Billing Methods Definitions Intermediary and Carrier Calculation of Payment Amount General Components of the Ambulance Fee Schedule ZIP Code Determines Fee Schedule Amounts Transition Overview 89
2003 Clinical Lab Fee Schedule and Lab Services Subject to Reasonable Charge Elimination of the 90day Grace Period for Health Common Procedure Coding System (Level I and Level II) Deleted Health Common Procedure Coding System Codes/Modifiers Access to Clinical Diagnostic Lab Fee Schedule Files Fee Schedules Used by All Intermediaries and Regional Home Health Intermediaries 90
Bundled Services for Skilled Nursing Facility Edit for Therapy Services Separately Payable When Furnished by a Physician 91
CR 3077, Processing NonCovered Home Health Prospective Payment System Charges Intermediary Processing of NoPayment Bills 92
CR 3070, April Quarterly Update to Jan 2004 Annual Update of Health Common Procedure Coding System Used for Skilled Nursing Facility Consolidated Billing Enforcement Consolidated Billing Requirements for Skilled Nursing Facility Services Included in Part A PPS Payment Not Billable Separately by the Skilled Nursing Facility Other Excluded Services Beyond the Scope of a Skilled Nursing Facility Part A Benefit Cardiac Catheterization Computerized Axial Tomography Scans Magnetic Resonance Imaging Outpatient Surgery and Related Procedures-- Inclusion Radiation Therapy Angiography, Lymphatic, Venous and Related Procedures Emergency Services Services Excluded from Part A PPS Payment and the Consolidated Billing Requirement on the Basis of Beneficiary Characteristics and Election ESRD Services Coding Applicable to Services Provided in a Renal Dialysis Facility or Skilled Nursing Facility as Home
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Coding Applicable to EPO Services Other Services Excluded from Skilled Nursing Facility Prospective Payment System and Consolidated Billing Ambulance Services Chemotherapy, Chemotherapy Administration, and Radioisotope Services Certain Customized Prosthetic Devices Screening and Preventive Services Therapy Services 93
Remittance Advice Remark Code and Claim Adjustment Reason Code Update CR 3122 94
Additional Information in Medicare Summary Notices to Beneficiaries About Skilled Nursing Facility Benefits CR 3098 Other Billing Situations Skilled Nursing Facilities Benefit Limits Instalacion de Enferemeria Especializada Limites En Los Beneficios 95
Elimination of the 90-day Grace Period for ICD 9-CM Codes CR 3094 Relationship of ICD-9-CM Codes and Date of Service 96
Update to Claims Status Codes CR 3017 Health Care Claims Status Category Codes and Health Care Claim Status Codes For Use with the Health Care Claim Status Request and Response ASC X12N 276/277 97
Implementation of New Medicare Redetermination Notice CR 2620 98
Consolidation of Claims Crossover Process: Common Working File Functionality Crossover Claims Requirements Fiscal Intermediary Requirements Carrier/Durable Medical Equipment Regional Carrier Requirements Consolidated Claims Crossover Process Claims Crossover Disposition Indicators Assignment of Claims and Transfer Policy Beneficiary Insurance Assignment Selection Form CMS-1500 (ANSI X12N 837 COB (Version 4010) Remittance Advice Messages Returned Medigap Notices Coordination of Medicare with Medigap and Other Complementary Health Insurance Policies Standard Medicare Charges for COB Records Consolidation of the Claims Crossover Process Electronic Transmission--General Requirements ANSI X12N 837 COB (Version 4010) Transaction Fee Collection Medigap Electronic Claims Transfer Agreements Intermediary Crossover Claim Requirements Carrier/DMERC Crossover Claim Requirements 99
HIPAA X12N 837 Coordination of Benefits Gap Fill Additional Instruction CR 3100 Crossover Requirements 100
Outpatient Clinical Laboratory Tests Furnished by Hospitals with Fewer than 50 Beds in Qualified Rural Areas CR 3130 Hospital Billing Under Part B 101
Restoring Composite Rate Exceptions for Pediatric Facilities Under the End-Stage Renal Disease Composite Rate System CR 3119 Processing Requests for Composite Rate Exception 102
New Waived Test--April 1, 2004 Certificate of Waiver 103
Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115 Percent Fee Schedule Payment for Professional Services CR 3114 104
Durable Medical Equipment Regional Carrier and VMS-Instructions for Processing CR 3141 Billing Drugs Electronically--National Council of Prescription Drug Programs 105
First Update to the 2004 Medicare Physician Fee Schedule Database CR 3128 106
Modification of Requirements in CR 2716, Common Working File Edits to Ensure Accurate Coding and Payment for Discharge and/or Transfer Policies CR 3137 107
Health Insurance Portability and Accountability of Act of 1996 X12N 837 Health Care Claim Implementation Guide Editing Additional Instruction CR 3031 X12N 837 Institutional Implementation Guide Edits FI Requirements Edits Performed by the Fiscal Intermediary 108
Type of Service Corrections, Chapter 26, Section 10.7 CR 3018 109
Updated Policy and Claims Processing Instructions for Ambulatory Blood Pressure Monitoring Billing CR 2726 Diagnostic Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring Billing Requirements 110
New Requirement for Payment of Drugs CR 3078 Drugs Furnished in Dialysis Facilities 111
Payment for Services Provided Under a Contractual Arrangement CR 3083 General Billing Requirements Payment to Facility in Which Services Are Performed--Carrier Claims Carrier Payment to Health Care Delivery System--Carrier Claims Definition of Health Care Delivery System
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112
Changes to Outpatient Prospective Payment System Change Request 3144 113
Claims Requiring Adjustment as a Result of April 2004 Changes to the Outpatient Prospective Payment System Change Request 3145 114
Changes in Payment Floor Calculation for Claims Submitted Electronically in a Non- HIPAA Change Request 2981 Receipt Date Payment Ceiling Standards Payment Floor Standards Determining and Paying Interest 115
Durable Medical Equipment Regional Carrier and Voucher Insurance Plan, Processing National Drug Code Numbers--Clarification to Change Request 3141 116
End-Stage Renal Disease Miscellaneous Code Processing Clarification Durable Medical Equipment Regional Carrier Claims Processing Instructions 117
Instructions for Downloading the Medicare Zip Code File 118
Policy Changes To Reflect Billing for Darbepoetin Alfa and Epoetin Epoetin Alfa (EPO) Facility Billing Requirements Using UB-92/Form CMS-1450 Other Information Required on the Form CMS- 1500 for Epoetin Alfa (EPO) Completion of Subsequent Form CMS-1500 Claims for Epoetin Alfa (EPO) Payment Amount for Epoetin Alfa (EPO) Payment for Epoetin Alfa (EPO) in Other Settings Epoetin Alfa (EPO) Provided in the Hospital Outpatient Departments Epoetin Alfa (EPO) Furnished to Home Patients Darbepoetin Alfa (Aranesp) for ESRD Patient Darbepoetin Alfa (Aranesp) Facility Billing Requirements Using UB-92/Form CMS- 1450 Darbepoetin Alfa (Aranesp) Supplier Billing Requirements (Method II) on the Form CMS-1500 and Electronic Equivalent Other Information Required on the Form CMS- 1500 for Darbepoetin Alfa (Aranesp) Completion of Subsequent Forms CMS-1500 Claims for Darbepoetin Alfa (Aranesp) Payment Amount for Darbepoetin Alfa (Aranesp) Payment for Darbepoetin Alfa (Aranesp) in Other Settings Payment for Darbepoetin Alfa (Aranesp) in the Hospital Outpatient Department Darbepoetin Alfa (Aranesp) Furnished to Home Patients Billable UB-92 Revenue Codes Under Method II 119
Medicare Modernization Act Drug Pricing Update-Drug Exceptions 120
January Medicare OCE Specifications Version 19.1R1 121
Manualization of Place of Service Code Set Program Memorandum Revision to Group Home Code Description Item 14-33--Provider of Service or Supplier Information Place of Service Codes (POS) and Definitions 122
Revision to Required Messages in Change Request 2944, Implementation of Skilled Nursing Facility/Consolidated Billing Edit for Therapy Codes 123
April Outpatient Code Editor 124
Billing and Coding Requirements for Electromagnetic Therapy for the Treatment of Wounds Wound Treatments Electrical Stimulation Electromagnetic Therapy 125
Manualization of the Sacral Nerve Stimulation Sacral Nerve Stimulation Coverage Requirements Billing Requirements Healthcare Common Procedural Coding System Payment Requirements for Test Procedures (Healthcare Common Procedural Coding System Codes 64585, 64590, and 64595 Payment Requirements for Device Codes A4290, E0752, and E0756 Payment Requirements for Codes C1767, C1778, C1883, and C1897 Bill Types Revenue Codes Claims Editing 126
Clarification of ICD-9-Coding Clarification of ICD-9-CM Diagnosis and Procedure Codes 127
2004 Jurisdiction List Use and Acceptance Healthcare Common Procedural Codes and Modifiers 128
Deep Brain Stimulation for Essential Tremor and Parkinson's Disease Coverage Billing Requirements Part A Intermediary Billing Procedures Payment Requirements Part A Methods Bill Types Revenue Codes Allowable Codes Allowable Covered Diagnosis Codes Allowable Covered Procedure Codes
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Healthcare Common Procedure Coding System Ambulatory Surgical Centers Claims Editing for Intermediaries Remittance Advice Notice for Intermediaries Medicare Summary Notices Messages for Intermediaries Provider Notification 129
Additional Info and Corrections to Previous Transmittals Re: HCPCS Codes and Modifiers for Low Osmolar, etc. 130
Chapter 32, Section 60 ff Coverage Billing for Home Prothrombin Time (INR) Monitoring for Anticoagulation Management Coverage Requirements Intermediary Payment Requirements Part A Payment Methods Intermediary Billing Procedures Bill Types Revenue Codes Intermediary Allowable Codes Allowable Covered Diagnosis Codes Healthcare Common Procedure Coding System for Intermediaries Carrier Billing Instructions Healthcare Common Procedure Coding System for Carriers Applicable Diagnosis Code for Carriers Carrier Claims Requirements Carrier Payment Requirements Carrier and Intermediary General Claims Processing Instructions Remittance Advice Notice Medicare Summary Notice Messages 131
Revised Payment Allowance Percentage for Durable Medical Equipment Regional Carrier Drugs--Off Cycle Release Payment Allowance Limit for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis 132
April 2004 Update of the Hospital Outpatient Prospective Payment System Updates
Medicare Secondary Payer (CMS-Pub. 100-05)
08
Common Working File Medicare Secondary Payor Modifications Change Request 2775 Medicare Secondary Payor Add Transactions Medicare Secondary Payor Change Transaction Medicare Secondary Payor Delete Transaction Automatic Notice of Change to Medicare Secondary Payor Auxiliary File 09
Converting Health Insurance Portability and Accountability Act of 1996 Individual Relation Change Request 3116 Conversion of Health Insurance Portability and Accountability Act of 1996 Individual Relationship Codes to Common Work File Patient Relationship Codes for the Creation of Medicare Secondary Payor HUSP Transactions 10
Update to the Shared Systems to Send the Appropriate Medicare Fee Schedule Amount Change Request 2955 11
Medicare Secondary Payor Policy for Certain Services Change Request 3064 General Policy Selection of Bill Sample 12
Interim Non-System Solution: Converting Health Insurance Portability and Accountability Act Individuals Relationship Codes to Common Working File Converting Health Insurance Portability and Accountability Act Individual Relationship Codes to Common Working File Patient Relationship Codes 13
Update to the ECRS User Guide v7.0 and Quick Reference Card v7.0
Medicare Financial Management (CMS-Pub. 100-06)
33
Coordination of Medicare and Complementary Insurance Programs Coordination of Medicare with the Federal Grants-In-Aid Program Furnishing Title XVIII Claims Information Treatment of Administrative Cost of Furnishing Information to State Agencies Coordination of Medicare and Medicare Supplemental (Medigap) Health Insurance Policies 34
Chapter 7--Internal Control Requirements Update Risk Assessment Fiscal Year 2004 Medicare Control Objectives Requirements Certification Statement Executive Summary Report of Material Weaknesses Report of Reportable Conditions 35
Unsolicited/Voluntary Refunds General Information Office of the Inspector General Initiatives Unsolicited/Voluntary Refund Accounts
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Receiving and Processing Unsolicited/ Voluntary Refund Checks When Identifying Information is Provided Handling Checks or Associated Correspondence with Conditional Endorsements Receiving and Processing Unsolicited/ Voluntary Refund Checks When Identifying Information Is Not Provided CMS Reporting Requirements Overpayment Refund--Summary Report Unsolicited/Voluntary Refund Checks-- Summary Report Education 36
Medicare Contractor Transaction Report Due Date Heading Body of Report 37
Installation of Version 33 of the Provider Statistical and Reimbursement Reporting System.
Medicare Program Integrity (CMS-Pub. 100-08)
66
Progressive Corrective Action General Information Review of Data Probe Reviews Target Medical Review Activities Requesting Additional Information Provider Error Rate Provider Feedback and Education Overpayments Fraud Track Interventions Track Appeals Implementation Vignettes 67
The Medicare Coverage Databases Change Request 2976 Comprehensive Error Rate Testing Program Safeguard Contractor Affiliated Contractor Full PSC Communication with the Comprehensive Error Rate Testing Contractor Overview of the Comprehensive Error Rate Testing Process AC/Full PSC Requirements Surrounding Comprehensive Error Rate Testing Reviews Providing Sample Information to the Comprehensive Error Rate Testing Contractor Providing Review Information to the Comprehensive Error Rate Testing Contractor Providing Feedback Information to the Comprehensive Error Rate Testing Contractor Disputing/Disagreeing with a Comprehensive Error Rate Testing Decision Handling Overpayments and Underpayments Resulting from the Comprehensive Error Rate Testing Findings Handling Appeals Resulting from Comprehensive Error Rate Testing Initiated Denials Tracking Overpayments and Appeals Potential Fraud AC/Full PSC Requirements Involving Comprehensive Error Rate Testing Information Dissemination AC/Full PSC CERT Points of Contact AC/Full PSC Error Rate Reduction Plan 68
Program Requirements to Support Medical Review of Home Health Prospective Payment System Change Request 2519 69
Revision of Enrollment Instructions Change Request 3159 Contractor Duties Processing the Application Identification Practice Location Ownership and Managing Control Information (Individuals) Qualification of Crew Review of Attachment 2, Independent Diagnostic Testing Facilities Reassignment of Benefits Statement of Termination Reassignment of Benefits Statement Attestation Statement Practice Location Ownership and Managing Control Information (Individuals) Changes of Information--New Form CMS855 Data Approval and Recommendations for Approval Time Frame for Application Processing
Medicare Contractor Beneficiary And Provider Communications (CMS Pub. 100-09)
04
Provider/Supplier Communications
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Introduction Provider Communications--Program Elements Provider Service Plan Provider Inquiry Analysis Provider Data Analysis Provider Communications Advisory Group Bulletins/Newsletters Seminars/Workshops/Teleconferences New Technologies/Electronic Media Training of Providers in Electronic Claims Submission Provider Education and Beneficiary Use of Preventive Benefits Internal Development of Provider Issues Training of Provider Education Staff Partnering with External Entities Other Provider Education Subjects and Activities Provider Education Material Provider Service Plan Quarterly Activity Report Charging Fees to Providers for Medicare Education and Training Activities Provider Information and Education Materials and Resource Directory Provider/Supplier Communication--Program Elements Provider/Supplier Service Plan Provider/Supplier Inquiry Analysis Provider/Supplier Data Analysis Provider/Supplier Communications Advisory Group Bulletins/Newsletters Seminars/Workshops/Teleconferences New Technologies/Electronic Media Training of Providers/Suppliers in Electronic Claims Submission Provider/Supplier Education and Beneficiary Use of Preventive Benefits Internal Development of Provider/Supplier Issues Training of Provider/Supplier Education Staff Partnering with External Entities Other Specific Provider/Supplier Education Subjects and Activities Provider/Supplier Education Material PSP Quarterly Activity Report Charging Fees to Providers/Suppliers for Medicare Education and Training Activities Provider/Supplier Information and Education Materials and Resource Directory
Medicare EndStage Renal Disease Network Organizations (CMS Pub. 10014)
05
Chapter 4 Information Management Background/Authority Responsibilities System Capacity Hardware/Software Requirements CMS Computer Systems Access Data Security Confidentiality of Data Database Management Patient Database Mandatory Data Element Patient Database Updates CMSDirected Changes (Notifications) to the Network Patient Database Facility Database Mandatory Data Elements Submission of Facility Database Elements ESRD Data and Reporting Requirements Centers for Medicare & Medicaid Services EndStage Renal Disease Forms Centers for Medicare & Medicaid Services EndStage Renal Disease Program Forms Centers for Medicare & Medicaid Services EndStage Renal Disease Clinical Performance Measures Data Forms CMS ESRD Beneficiary Selection Form Collection, Completion, Validation, and Maintenance of the EndStage Renal Disease CMS Forms Processing Form CMS-2728-U3 Processing Form CMS-2746 (EndStage Renal Disease Death Notification Form) Processing Form CMS2744 (EndStage Renal Disease Facility Survey) Tracking System for EndStage Renal Disease Forms Compliance Rates for Submitting EndStage Renal Disease Forms CMS Forms Data Discrepancies and Data Corrections Renal Transplant Data Reporting on Continued Status of Medicare EndStage Renal Disease
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Beneficiaries Coordination of Additional Renal Related Information VISION Data Validation 06
Chapter 6--Community Information and Resources Quarterly Progress and Status Report Provision of Educational Information-- Providers/Facilities Provision of Educational Information-- Patients Provision of Technical Assistance Resolution of Difficult Situations and Grievances 07
Chapter 7--Sanctions and EndStage Renal Disease Complaint Grievances Network's Role Prior to Initiating Sanction Recommendations Written Documentation Requirements for Sanction Recommendations Forwarding Sanction Recommendations Project Officer's Role in Sanction Procedures Regional Officer's Role in Sanction Procedures Duration and Removal of Alternative Sanctions Quality of Care Referrals Definitions for the EndStage Renal Disease Complaint and Grievance Process Role of Network in a Complaint/Grievance End-Stage Renal Disease Complaint and Grievance Process Facility Awareness of the Complaint/ Grievance Process Use of Facility Complaint/Grievance Process Determination of Network Involvement Receiving a Complaint/Grievance Request of Grievance in Writing Referring Complaints and Grievances Written Acknowledgment of Grievance Investigation of Complaints and Grievances Life-Threatening Situations Challenging Patient Situations Advocating for Patient Rights Addressing a Complaint or Grievance Follow-Up of a Grievance Conclusion of a Grievance Investigation Report and Letter to the Grievant Complaint/Grievance Is Closed Complaint/Grievance Is Resolved Complaint/Grievance Is Referred Complaint/Grievance Is Reopened Improvement Plans Content of Improvement Plans Time Period for Review and Acceptance/Rejection of Improvement Plans Tracking System Conclusion of Improvement Plans Identity of Complainant/Grievant Identity of Practitioner Identity of Facility Personal Representative
Medicare Managed Care (CMS Pub. 100-16)
45
Chapter 13 Revision 1 Written Notification by Medicare+Choice Organizations Withdrawal of Request for Reconsideration Filing a Request for DAB Review Standard Service Requests Effectuating Decisions by All Other Review Entities Independent Review Entity Monitoring of Effectuation Requirements Data 46
Chapter 19--January Updates General Cost-Based Managed Care Organizations Only Medicare+Choice Managed Care Organizations Only Cost-Based Managed Care Organizations Only Medicare+Choice Organizations Only Submission of Correction Transaction Records Prior Commercial Months Field ''Special Status'' Beneficiaries-- Medicare+Choice Organizations ``Special Status''--Hospice ``Special Status''--End-Stage Renal Disease ``Special Status''--Institutionalized ``Special Status''--Working Aged
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When to Submit ``Special Status'' Information (Medicare+Choice Organizations Only) Timeliness Requirements Sending the Transaction File to Centers for Medicare & Medicaid Services Electronic Data Transfer Data Processing Vendor CMS' Transaction Reply/Monthly Activity Report Transaction Reply Field Information Plan Payment Report Demographic Report Managed Care Organizations Only Monthly Membership Report Bonus Payment Report Retroactive Payment Adjustment Policy Standard Operating Procedures for State and County Code Adjustments Standard Operating Procedures for Medicaid Retroactive Adjustments Standard Operating Procedures for EndStage Renal Disease Retroactive Adjustments Processing of Working Aged Retroactive Adjustments Standard Operating Procedures for Retroactive Adjustment of Plan Elections Medicare Customer Service Center Disenrollments Duplicate Payment Prevention by CostBased Managed Care Organization 47
Chapter 7--Medicare+ChoiceEnrollment and Disenrollment Prefatory Note General Rules for M+C Payments Enrollees With End-Stage Renal Disease Medicare+Choice Payment Methodology A Minimum Specified Amount or ``Floor'' Rate Adjustment of Capitation Rates for National Coverage Determinations and Legislative Changes in Benefits Criteria for Meeting ``Significant Cost'' Rules Coverage and Payment of ``Significant Cost'' National Coverage Determination Before Adjustments to Annual Medicare+Choice Capitation Rate Are Effective After Adjustments to the Annual Medicare+Choice Capitation Rates Are in Effect Adjustment of Capitation Rates for Working Aged Status Adjustment of Capitation Rates for Demographic Characteristics and Health Status Transition to a Comprehensive Risk Adjustment Method Transition Schedule for Implementation of the Risk Adjustment Method The CMS-HCC Risk Adjustment Method for Adjustment of Capitation Rates Demographic Factors Under the CMS-HCC Risk Adjustment Method Age and Sex Medicaid Eligibility Originally Disabled The Medicare+Choice-Health Care Compare Classification System Institutional Adjuster in the CMS-Health Care Compare Model Implementation of the CMS-Health Care Compare Model Elimination of the Data Lag Implementation of the Adjustment for Long- Term Institutionalization New Enrollees Calculation of Beneficiary Risk Scores Calculation of Monthly Payments to Medicare+Choice Organizations The Rescaling Factor Adjustment to Rescaling Factors for Budget Neutrality Adjustment in Rescaling Factors for Coding Intensity Calculating the Payment Amount Per Medicare+Choice Enrollee Changes in Methodology for PACE and Certain Demonstrations Application of Frailty Model Application of Frailty Factor to Medicare+Choice Organizations Exclusions from Risk Adjustment Payment Data Collection and Submission for Risk Adjustment Care Hospital Inpatient Data Outpatient Hospital Physician Data Alternative Data Sources Data Collection Diagnosis Submission Submission Methods Submission Frequency Certification of Data Accuracy, Completeness, and Truthfulness Data Validation Announcement of Annual Capitation Rates and Methodology Change Terminology Policy Special Rules for Medicare+Choice Payments to Department of Veterans Affairs Facilities
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Eligibility for Bonus Payment/The Period of Application Reconciliation Process for Changes in Risk Adjustment Factors Additional Information on Coverage of Clinical Trials Community and Institutional Annual Risk Factors for the CMS-Health Care Compare Model with Constraints and Demographic/Disease Interactions List of Disease Groups (Health Care Compare) with Hierarchies CMS-HCC Demographic Model for New Enrollees Data Collection for Risk Adjustment/ Facility Types and Physician Specialties Retired Material on the PIP-DCG Payment Methodology (Former Sections 90 and 110, Exhibits 4 and 5) Retired Material on the Congestive Heart Failure Extra Payment Initiative (Former Section 100 and Exhibits 6 and 7) 48
Grievances, Organization Determinations, and Appeals 49
Chapter 4--Benefits and Beneficiary Protections Access and Availability Rules for Coordinated Care Plans Rules for All Medicare+Choice Organizations to Ensure Continuity of Care 50
Chapter 20--Plan Communications Guide View Beneficiary Factors (Option 9) System Description GROUCH Options Downloading Your Group Health Plan Monthly Report The Common Working File Logging Onto Common Working File Beneficiary Eligibility Data 51
Revisions to Chapter 2--Medicare+Choice Enrollment and Disenrollment End-Stage Renal Disease End-Stage Renal Disease and Enrollment Effective Date
Medicare Business Partners Systems Security (CMS-Pub. 100-17)
04
Federal Laws Introduction The (Principal) Systems Security Officer IT Systems Security Program Management System Security Plan Risk Assessment Certification Information Technology Systems Contingency Plan Annual Compliance Audit Corrective Action Plan Computer Security Incident Response Information Security Levels Level 4: High Criticality and National Security Interest Sensitive Information Protection Requirements Restricted Area Security Room Secured Interior/Secured Perimeter Container Locked Container Security Container Safe/Vaults Locking Systems for Secured Areas and Security Rooms Intrusion Detection Equipment Internet Security Core Security Requirements and the Contractor Assessment Security Tool CMS Core Set of Security Requirements Medicare Information Technology Systems Contingency Planning An Approach to Fraud Control Glossary
One Time Notification (CMS Pub. 10020)
56
Program Integrity Management Reporting System for Part A Phase 4 57
Instructions for Fiscal Intermediary Standard System and MultiCarrier System Healthcare Integrated General Ledger Accounting Systems Changes 58
Program Integrity Management Reporting System Fiscal Year 2004 H and T Codes 59
Temporary 5 % Payment Increase for Home Health Services Furnished in a Rural Area CR 3085 60
Instructions for Fiscal Intermediary Standard System and MultiCarrier System Healthcare Integrated General Ledger Accounting System Changes
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61
FY 2004 Graduate Medical Education Payments as Required by the Medicare Modernization Act of 2003 62
Physician SelfReferral Prohibition 12/22/ 2003 18Month Moratorium on Physician Investment in Specialty Hospitals CR 3036 63
Durable Medical Equipment Regional Carriers DeWall Posture Protector 64
Implementation of Sections 401, 402, 504, and 508(a) of the Medicare Modernization Act of 2003 65
Implementation of Sec. 508(f) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 66
CWF Corrections to the 270/271 Transaction
Addendum IV.--Regulation Documents Published in the Federal Register (January 2004 Through March 2004)
FR vol. Publication date
69 page
CFR parts affected
File code
Title of regulation number
January 6, 2004....................... 820 42 CFR Part 419................................ CMS-1371-IFC............. Medicare Program; Hospital Outpatient Prospective Payment System; Payment Reform for Calendar Year 2004. January 6, 2004....................... 665 ............................................... CMS-4065-N............... Medicare Program; Meeting of the Advisory Panel on Medicare Education. January 6, 2004....................... 661 ............................................... CMS-1373-N............... Medicare Program; Notice of One-Time Appeal Process for Hospital Wage Index Classification. January 6, 2004....................... 565 42 CFR Part 447................................ CMS-2188-P............... Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program. January 7, 2004....................... 508 42 CFR Part 447................................ CMS-2175-IFC............. Medicare Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program. January 7, 2004....................... 1084 42 CFR Parts 405 and 414....................... CMS-1372-IFC............. Medicare Program; Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004. January 23, 2004...................... 3434 45 CFR Part 162................................ CMS-0045-F............... HIPAA Administrative Simplification: Standard Unique Health Identifier for Health Care Providers. January 23, 2004...................... 3371 ............................................... CMS-1362-N............... Medicare Program; February 23-24, 2004, Meeting of the Practicing Physicians Advisory Council. January 23, 2004...................... 3370 ............................................... CMS-1375-N............... Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classifications Group. January 30, 2004...................... 4820 42 CFR Part 412................................ CMS-1263-P............... Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates and Policy Changes. January 30, 2004...................... 4464 42 CFR Parts 412, 413, and 424................. CMS-1213-N............... Medicare Program; Prospective Payment System for Inpatient Psychiatric Facilities; Extension of Comment Period. February 13, 2004..................... 7340 ............................................... CMS-1373-N2.............. Medicare Program; Revisions to the One-Time Appeal Process for Hospital Wage Index Classification. February 27, 2004..................... 9326 ............................................... CMS-2200-N............... Medicare Program; Request for Nominations for the State Pharmaceutical Assistance Transition Commission. February 27, 2004..................... 9324 ............................................... CMS-1268-N............... Medicare Program; Town Hall Meeting on the Fiscal Year 2005 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment. February 27, 2004..................... 9323 ............................................... CMS-4090-N............... Medicare Program; Town Hall Meeting on Proposed Collection--Comment Request for Skilled Nursing Facility Advance Beneficiary Notice. February 27, 2004..................... 9322 ............................................... CMS-3112-N............... Medicare Program; Calendar Year 2004 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs). February 27, 2004..................... 9321 ............................................... CMS-4070-N............... Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education. February 27, 2004..................... 9282 42 CFR Part 473................................ CMS-3121-P............... Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing Information. March 5, 2004......................... 10455 ............................................... CMS-2200-N2.............. Medicare Program; Establishment of the State Pharmaceutical Assistance Transition Commission.
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March 26, 2004........................ 16054 42 CFR Parts 411 and 424....................... CMS-1810-IFC............. Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships. March 26, 2004........................ 15884 ............................................... CMS-4071-N............... Medicare Program; Listening Session on Performance Measures for Public Reporting on the Quality of Hospital Care--April 27, 2004. March 26, 2004........................ 15850 ............................................... CMS-2062-N............... Medicaid Program; Disproportionate Share Hospital Payments. March 26, 2004........................ 15837 ............................................... CMS-9020-N............... Medicare and Medicare Programs; Quarterly Listing of Program Issuances--October 2003 Through December 2003. March 26, 2004........................ 15835 ............................................... CMS-2183-N............... Funding Opportunity Title: Medicaid Program; Medicaid Infrastructure Grant Program To Support the Competitive Employment of People With Disabilities. March 26, 2004........................ 15755 42 CFR Part 421................................ CMS-1219-P............... Medicare Program; Durable Medical Equipment Regional Carrier (DMERC) Service Areas and Related Matters. March 26, 2004........................ 15729 42 CFR Parts 410 and 414....................... CMS-1476-CN2............. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004; Correction. March 26, 2004........................ 15703 42 CFR Parts 405 and 414....................... CMS-1372-CN.............. Medicare Program; Changes to the Medicare Payment for Drugs for Calendar Year 2004, Correction.
Addendum V--National Coverage Determinations [January 2004 Through March 2004]
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 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 Determinations (January 2004 Through March 2004)
100-03
Title
Issue date Effective date
270.1......... Electrical
03/19/04
07/01/04 Stimulation and Electromagnetic Therapy for the Treatment of Wounds. 20.16......... Cardiac Output
01/23/04
02/23/04 Monitoring by Thoracic Electrical Bioimpedance. 160.23........ Current Perception 03/19/04
04/01/04 Threshold/Sensory Nerve Conduction Threshold Test.
100-04
Title
Issue date Effective date
TR 71......... Clinical Lab Table 01/23/04
04/05/04 Update for April 2004.
Addendum VI--FDA-Approved Category B IDEs
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to nonexperimental IDEs. 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 list includes all Category B IDEs approved by FDA during the 1st quarter, January 2004 Through March 2004.
IDE
Category
G010093.....................................................
B G020138.....................................................
B G020290.....................................................
B G030194.....................................................
B G030235.....................................................
B G030261.....................................................
B G030263.....................................................
B G030264.....................................................
B G030265.....................................................
B G030267.....................................................
B G030268.....................................................
B G030269.....................................................
B
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G040001.....................................................
B G040005.....................................................
B G040007.....................................................
B G040008.....................................................
B G040009.....................................................
B G040012.....................................................
B G040013.....................................................
B G040014.....................................................
B G040016.....................................................
B G040018.....................................................
B G040019.....................................................
B G040021.....................................................
B G040022.....................................................
B G040024.....................................................
B G040025.....................................................
B G040027.....................................................
B G040028.....................................................
B G040029.....................................................
B G040030.....................................................
B G040031.....................................................
B
Addendum VIIApproval Numbers for Collections of Information
Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:
OMB Control Numbers--Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by ``45 CFR,'' and sections in Title 20 are preceded by ``20 CFR'')
OMB number
Approved CFR sections
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 0938-0035........................... 407.40 0938-0037........................... 413.20, 413.24 0938-0041........................... 408.6, 408.22 0938-0042........................... 410.40, 424.124 0938-0045........................... 405.711 0938-0046........................... 405.2133 09380050........................... 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........................... 442.30, 488.26 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, 413.184 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, 482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66, 485.618, 485.631 0938-0334........................... 491.9, 491.10 0938-0338........................... 486.104, 486.106, 486.110 0938-0354........................... 441.60 0938-0355........................... 442.30, 488.26 0938-0357........................... 409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21 0938-0358........................... 412.20-412.30 0938-0359........................... 412.40-412.52 0938-0360........................... 488.60 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........................... 488.26, 442.30 0938-0382........................... 488.26, 442.30 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 0938-0448........................... 405.2133, 45 CFR 5, 5b; 20 CFR Parts 401, 422E 0938-0449........................... 440.180, 441.300-441.310 0938-0454........................... 424.20 0938-0456........................... 412.105 0938-0463........................... 413.20, 413.24, 413.106 0938-0467........................... 431.17, 431.306, 435.910, 435.920, 435.940-435.960 0938-0469........................... 417.107, 417.478 0938-0470........................... 417.143, 417.800-417.840, 422.6 0938-0477........................... 412.92 0938-0484........................... 424.123 0938-0501........................... 406.15 0938-0502........................... 433.138 0938-0512........................... 486.304, 486.306, 486.307 0938-0526........................... 475.102, 475.103, 475.104, 475.105, 475.106 0938-0534........................... 410.38, 424.5 0938-0544........................... 493.1-493.2001 0938-0564........................... 411.32 0938-0565........................... 411.20-411.206 0938-0566........................... 411.404, 411.406, 411.408 0938-0573........................... 412.230, 412.256 0938-0578........................... 447.534 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........................... 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493,1252, 493.1253, 493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273, 493.1274, 493.1278, 493.1283, 493.1289, 493.1291, 493.1299 0938-0618........................... 433.68, 433.74, 447.272 0938-0653........................... 493.1771, 493.1773, 493.1777 0938-0657........................... 405.2110, 405.2112 0938-0658........................... 405.2110, 405.2112 0938-0667........................... 482.12, 488.18, 489.20, 489.24 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........................... 486.304, 486.306, 486.307, 486.310, 486.316, 486.318, 486.325 0938-0690........................... 488.4-488.9, 488.201 0938-0691........................... 412.106 0938-0692........................... 466.78, 489.20, 489.27 0938-0701........................... 422.152 0938-0702........................... 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 46.180 0938-0703........................... 45 CFR 148.120, 148.124, 148.126, 148.128 0938-0714........................... 411.370-411.389 0938-0717........................... 424.57 0938-0721........................... 410.33 0938-0722........................... 422.370-422.378
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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........................... 484 Subpart E, 484.55 0938-0761........................... 484.11, 484.20 0938-0763........................... 422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622 0938-0768........................... 417.800-417.840 0938-0770........................... 410.2 0938-0778........................... 422.64, 422.111 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........................... 491.8, 491.11 0938-0798........................... 413.24, 413.65, 419.42 0938-0802........................... 419.43 0938-0818........................... 410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63 0938-0829........................... 422.620, 422.624, 422.626 0938-0832........................... 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........................... 412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64 0938-0846........................... 411.1, 411.350-411.357, 424.22 0938-0857........................... 419 0938-0860........................... 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........................... 422 0938-0883........................... 45 CFR Parts 160 and 164 0938-0887........................... 45 CFR 148.316, 148.318, 148.320 0938-0897........................... 412.22, 412.533 0938-0907........................... 412.230, 412.304, 413.65 0938-0910........................... 422.620, 422.624, 422.626 0938-0911........................... 426.400, 426.500 0938-0916........................... 483.16 0938-0920........................... 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.206, 438.207, 438.240, 438.242, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.710, 438.722, 438.724, 438.810
[FR Doc. 04-14274 Filed 6-24-04; 8:45 am]
BILLING CODE 4120-01-P
