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Notice

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January 2004 Through March 2004

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from 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 Start Printed Page 35635issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

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FOR FURTHER INFORMATION CONTACT:

It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.)

Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.

Questions concerning 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.

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SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame.

II. How to Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, 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.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Start Printed Page 35636Service (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.

B. Regulations and Notices

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

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

C. Rulings

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

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:

  • Titles XI, XVIII, and XIX of the Act.
  • CMS-related regulations.
  • CMS manuals and monthly revisions.
  • CMS program memoranda.

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

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

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

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the 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)

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Dated: June 14, 2004.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

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Addendum I

This addendum lists the publication dates of the most recent quarterly listings of program issuances.

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.Start Printed Page 35637

Addendum III—Medicare and Medicaid Manual Instructions

[January 2004 Through March 2004]

Transmittal No.Manual/Subject/Publication No.
Medicare General Information
(CMS-Pub. 10001)
02Scheduled Release for April Updates to Software and Pricing/Codes Files
03New Part B Annual Deductible
Medicare Benefit Policy
(CMS-Pub. 10002)
07Restoring Composite Rate Exceptions for Pediatric Facilities Under the End-Stage Renal Disease Composite Rate System
08Policy Changes to Reflect Billing for Darbepoetin Alfa and Epoetin
Medicare National Coverage Determinations
(CMS-Pub. 10003)
07Electrical Stimulation and Electromagnetic Therapy for the Treatment of Wounds
08Current Perception Threshold/Sensory Nerve Conduction Threshold Test
09Cardiac Output Monitoring by Thoracic Electrical Bioimpendance
Medicare Claims Processing
(CMS-Pub. 10004)
60Manualization 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
61Revises Diagnosis Coding Instructions for Requests for Anticipated Payment and Claims to Conform with Health Insurance Portability and Accountability Act of 1996 Requirements
62Correction to January 2004 Annual Update of Health Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement
63Special Rules for Critical Access Hospital Outpatient Billing
64Coding Change for Ventricular Assist Devices for Beneficiaries in a Medicare+Choice Plan
65ANSI X12 Transaction 835 Companion Document Change for Carriers, Durable Medical Equipment Regional Carriers, and Intermediaries
66Quarterly Update to Correct Coding Initiative Edits, Version 10.1, Effective April 1, 2004
67Revision to Change Request 2912: Coding, Testing, and Implementation Phases of Change Request 2631 for Jurisdiction
68New Requirements for Critical Access Hospitals. These Changes Have Been Established with the Medicare Prescription Drug Improvement, and Modernization Act of 2003, PL 108173
69Criteria for Using the CB Modifier
70Implementation 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)
71Changes to the Laboratory National Coverage Determination Edit Software for April 2004
72Update of Address for the Railroad Retirement Board
73Medicare Code Editor and IPPS Transfers between Hospitals
74Intravenous Immune Globulin
75Medicare Modernization Act Pricing File Clarifications
76Manualization 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
77Change in Methodology for Determining Payment for Outliers
Outlier Payments: CosttoCharge Ratios
78Update 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
79End Stage Renal Disease Reimbursement for Automated MultiChannel Chemistry Test(s)
80Extend Medicare Coverage for Certain Colorectal Cancer Screenings at Skilled Nursing Facility
Billing Requirements for Claims Submitted to Intermediaries
81Report Of Admission Date and Additional Edit Requirements for the X12N 837 Coordination of Benefits Transaction
Form Locator 2 Untitled
82EndStage Renal Disease Data for Use In Adjudicating Claims
Utilization of REMIS for Carrier Claims Adjudication
83New “K” Codes for Wheelchair Cushions
84Additional Guidelines for Implementing the National Council for Prescription Drug Program
National Council for Prescription Drug Program Implementation
85Payment 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
86X12N 837 Professional Implementation Guide Edits
87Coverage and Billing for Home Prothrombin Time International Normalized Ratio
Anticoagulation Management
IPPS Transfers Between Hospitals
88Implementation 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
892003 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
90Bundled Services for Skilled Nursing Facility
Edit for Therapy Services Separately Payable When Furnished by a Physician
91CR 3077, Processing NonCovered Home Health Prospective Payment System Charges
Intermediary Processing of NoPayment Bills
92CR 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
93Remittance Advice Remark Code and Claim Adjustment Reason Code Update CR 3122
94Additional 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
95Elimination of the 90-day Grace Period for ICD 9-CM Codes CR 3094
Relationship of ICD-9-CM Codes and Date of Service
96Update 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
97Implementation of New Medicare Redetermination Notice CR 2620
98Consolidation 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
99HIPAA X12N 837 Coordination of Benefits Gap Fill Additional Instruction CR 3100
Crossover Requirements
100Outpatient Clinical Laboratory Tests Furnished by Hospitals with Fewer than 50 Beds in Qualified Rural Areas CR 3130
Hospital Billing Under Part B
101Restoring Composite Rate Exceptions for Pediatric Facilities Under the End-Stage Renal Disease Composite Rate System CR 3119
Processing Requests for Composite Rate Exception
102New Waived Test—April 1, 2004 Certificate of Waiver
103Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115 Percent Fee Schedule Payment for Professional Services CR 3114
104Durable Medical Equipment Regional Carrier and VMS-Instructions for Processing CR 3141
Billing Drugs Electronically—National Council of Prescription Drug Programs
105First Update to the 2004 Medicare Physician Fee Schedule Database CR 3128
106Modification of Requirements in CR 2716, Common Working File Edits to Ensure Accurate Coding and Payment for Discharge and/or Transfer Policies CR 3137
107Health 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
108Type of Service Corrections, Chapter 26, Section 10.7 CR 3018
109Updated Policy and Claims Processing Instructions for Ambulatory Blood Pressure Monitoring Billing CR 2726
Diagnostic Blood Pressure Monitoring
Ambulatory Blood Pressure Monitoring Billing Requirements
110New Requirement for Payment of Drugs CR 3078
Drugs Furnished in Dialysis Facilities
111Payment 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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112Changes to Outpatient Prospective Payment System Change Request 3144
113Claims Requiring Adjustment as a Result of April 2004 Changes to the Outpatient Prospective Payment System Change Request 3145
114Changes 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
115Durable Medical Equipment Regional Carrier and Voucher Insurance Plan, Processing National Drug Code Numbers—Clarification to Change Request 3141
116End-Stage Renal Disease Miscellaneous Code Processing Clarification
Durable Medical Equipment Regional Carrier Claims Processing Instructions
117Instructions for Downloading the Medicare Zip Code File
118Policy 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
119Medicare Modernization Act Drug Pricing Update-Drug Exceptions
120January Medicare OCE Specifications Version 19.1R1
121Manualization 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
122Revision to Required Messages in Change Request 2944, Implementation of Skilled Nursing Facility/Consolidated Billing Edit for Therapy Codes
123April Outpatient Code Editor
124Billing and Coding Requirements for Electromagnetic Therapy for the
Treatment of Wounds
Wound Treatments
Electrical Stimulation
Electromagnetic Therapy
125Manualization 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
126Clarification of ICD-9-Coding
Clarification of ICD-9-CM Diagnosis and Procedure Codes
1272004 Jurisdiction List
Use and Acceptance Healthcare Common Procedural Codes and Modifiers
128Deep 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
Start Printed Page 35641
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
129Additional Info and Corrections to Previous Transmittals Re: HCPCS Codes and Modifiers for Low Osmolar, etc.
130Chapter 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
131Revised 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
132April 2004 Update of the Hospital Outpatient Prospective Payment System Updates
Medicare Secondary Payer
(CMS-Pub. 100-05)
08Common 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
09Converting 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
10Update to the Shared Systems to Send the Appropriate Medicare Fee Schedule Amount Change Request 2955
11Medicare Secondary Payor Policy for Certain Services Change Request 3064
General Policy
Selection of Bill Sample
12Interim 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
13Update to the ECRS User Guide v7.0 and Quick Reference Card v7.0
Medicare Financial Management
(CMS-Pub. 100-06)
33Coordination 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
34Chapter 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
35Unsolicited/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
36Medicare Contractor Transaction Report
Due Date
Heading
Body of Report
37Installation of Version 33 of the Provider Statistical and Reimbursement
Reporting System.
Medicare Program Integrity
(CMS-Pub. 100-08)
66Progressive 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
67The 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
68Program Requirements to Support Medical Review of Home Health Prospective
Payment System Change Request 2519
69Revision 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)
04Provider/Supplier Communications
Start Printed Page 35643
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)
05Chapter 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
Start Printed Page 35644
Beneficiaries
Coordination of Additional Renal Related Information
VISION Data Validation
06Chapter 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
07Chapter 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)
45Chapter 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
46Chapter 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
Start Printed Page 35645
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
47Chapter 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
Start Printed Page 35646
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)
48Grievances, Organization Determinations, and Appeals
49Chapter 4—Benefits and Beneficiary Protections
Access and Availability Rules for Coordinated Care Plans
Rules for All Medicare+Choice Organizations to Ensure Continuity of Care
50Chapter 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
51Revisions 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)
04Federal 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)
56Program Integrity Management Reporting System for Part A Phase 4
57Instructions for Fiscal Intermediary Standard System and MultiCarrier System Healthcare Integrated General Ledger Accounting Systems Changes
58Program Integrity Management Reporting System Fiscal Year 2004 H and T Codes
59Temporary 5 % Payment Increase for Home Health Services Furnished in a Rural Area CR 3085
60Instructions for Fiscal Intermediary Standard System and MultiCarrier System Healthcare Integrated General Ledger Accounting System Changes
Start Printed Page 35647
61FY 2004 Graduate Medical Education Payments as Required by the Medicare Modernization Act of 2003
62Physician SelfReferral Prohibition 12/22/2003 18Month Moratorium on Physician Investment in Specialty Hospitals CR 3036
63Durable Medical Equipment Regional Carriers DeWall Posture Protector
64Implementation of Sections 401, 402, 504, and 508(a) of the Medicare Modernization Act of 2003
65Implementation of Sec. 508(f) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
66CWF Corrections to the 270/271 Transaction

Addendum IV.—Regulation Documents Published in the Federal Register

(January 2004 Through March 2004)

Publication dateFR vol. 69 page numberCFR parts affectedFile codeTitle of regulation
January 6, 200482042 CFR Part 419CMS-1371-IFCMedicare Program; Hospital Outpatient Prospective Payment System; Payment Reform for Calendar Year 2004.
January 6, 2004665CMS-4065-NMedicare Program; Meeting of the Advisory Panel on Medicare Education.
January 6, 2004661CMS-1373-NMedicare Program; Notice of One-Time Appeal Process for Hospital Wage Index Classification.
January 6, 200456542 CFR Part 447CMS-2188-PMedicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program.
January 7, 200450842 CFR Part 447CMS-2175-IFCMedicare Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program.
January 7, 2004108442 CFR Parts 405 and 414CMS-1372-IFCMedicare Program; Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004.
January 23, 2004343445 CFR Part 162CMS-0045-FHIPAA Administrative Simplification: Standard Unique Health Identifier for Health Care Providers.
January 23, 20043371CMS-1362-NMedicare Program; February 23-24, 2004, Meeting of the Practicing Physicians Advisory Council.
January 23, 20043370CMS-1375-NMedicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classifications Group.
January 30, 2004482042 CFR Part 412CMS-1263-PMedicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates and Policy Changes.
January 30, 2004446442 CFR Parts 412, 413, and 424CMS-1213-NMedicare Program; Prospective Payment System for Inpatient Psychiatric Facilities; Extension of Comment Period.
February 13, 20047340CMS-1373-N2Medicare Program; Revisions to the One-Time Appeal Process for Hospital Wage Index Classification.
February 27, 20049326CMS-2200-NMedicare Program; Request for Nominations for the State Pharmaceutical Assistance Transition Commission.
February 27, 20049324CMS-1268-NMedicare 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, 20049323CMS-4090-NMedicare Program; Town Hall Meeting on Proposed Collection—Comment Request for Skilled Nursing Facility Advance Beneficiary Notice.
February 27, 20049322CMS-3112-NMedicare 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, 20049321CMS-4070-NMedicare Program; Request for Nominations for the Advisory Panel on Medicare Education.
February 27, 2004928242 CFR Part 473CMS-3121-PMedicare and Medicaid Programs; Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing Information.
March 5, 200410455CMS-2200-N2Medicare Program; Establishment of the State Pharmaceutical Assistance Transition Commission.
Start Printed Page 35648
March 26, 20041605442 CFR Parts 411 and 424CMS-1810-IFCMedicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships.
March 26, 200415884CMS-4071-NMedicare Program; Listening Session on Performance Measures for Public Reporting on the Quality of Hospital Care—April 27, 2004.
March 26, 200415850CMS-2062-NMedicaid Program; Disproportionate Share Hospital Payments.
March 26, 200415837CMS-9020-NMedicare and Medicare Programs; Quarterly Listing of Program Issuances—October 2003 Through December 2003.
March 26, 200415835CMS-2183-NFunding Opportunity Title: Medicaid Program; Medicaid Infrastructure Grant Program To Support the Competitive Employment of People With Disabilities.
March 26, 20041575542 CFR Part 421CMS-1219-PMedicare Program; Durable Medical Equipment Regional Carrier (DMERC) Service Areas and Related Matters.
March 26, 20041572942 CFR Parts 410 and 414CMS-1476-CN2Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004; Correction.
March 26, 20041570342 CFR Parts 405 and 414CMS-1372-CNMedicare 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)

100-03TitleIssue dateEffective date
270.1Electrical Stimulation and Electromagnetic Therapy for the Treatment of Wounds03/19/0407/01/04
20.16Cardiac Output Monitoring by Thoracic Electrical Bioimpedance01/23/0402/23/04
160.23Current Perception Threshold/Sensory Nerve Conduction Threshold Test03/19/0404/01/04
100-04TitleIssue dateEffective date
TR 71Clinical Lab Table Update for April 200401/23/0404/05/04

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.

IDECategory
G010093B
G020138B
G020290B
G030194B
G030235B
G030261B
G030263B
G030264B
G030265B
G030267B
G030268B
G030269B
Start Printed Page 35649
G040001B
G040005B
G040007B
G040008B
G040009B
G040012B
G040013B
G040014B
G040016B
G040018B
G040019B
G040021B
G040022B
G040024B
G040025B
G040027B
G040028B
G040029B
G040030B
G040031B

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 numberApproved CFR sections
0938-0008414.40, 424.32, 424.44
0938-0022413.20, 413.24, 413.106
0938-0023424.103
0938-0025406.28, 407.27
0938-0027486.100-486.110
0938-0033405.807
0938-0035407.40
0938-0037413.20, 413.24
0938-0041408.6, 408.22
0938-0042410.40, 424.124
0938-0045405.711
0938-0046405.2133
09380050413.20, 413.24
0938-0062431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5
0938-0065485.701-485.729
0938-0074491.1-491.11
0938-0080406.7, 406.13
0938-0086420.200-420.206, 455.100-455.106
0938-0101430.30
0938-0102413.20, 413.24
0938-0107413.20, 413.24
0938-0146431.800, 431.865
0938-0147431.800-431.865
0938-0151493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489
0938-0155405.2470
0938-0170493.1269-493.1285
0938-0193430.10-430.20, 440.167
0938-0202413.17, 413.20
0938-0214411.25, 489.2, 489.20
0938-0236413.20, 413.24
0938-0242442.30, 488.26
0938-0245407.10, 407.11
0938-0246431.800-431.865
0938-0251406.7
0938-0266416.41, 416.47, 416.48, 416.83
0938-0267410.65, 485.56, 485.58, 485.60, 485.64, 485.66
0938-0269412.116, 412.632, 413.64, 413.350, 484.245
0938-0270405.376
0938-0272440.180, 441.300-441.305
0938-0273485.701-485.729
0938-0279424.5
0938-0287447.31
0938-0296413.170, 413.184
0938-0300431.800
0938-0301413.20, 413.24
0938-0302418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100
0938-0313418.1-418.405
0938-0328482.12, 482.13, 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
0938-0334491.9, 491.10
0938-0338486.104, 486.106, 486.110
0938-0354441.60
0938-0355442.30, 488.26
0938-0357409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21
0938-0358412.20-412.30
0938-0359412.40-412.52
0938-0360488.60
0938-0365484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52
0938-0372414.330
0938-0378482.60-482.62
0938-0379488.26, 442.30
0938-0382488.26, 442.30
0938-0386405.2100-405.2171
0938-0391488.18, 488.26, 488.28
0938-0426476.104, 476.105, 476.116, 476.134
0938-0429447.53
0938-0443473.18, 473.34, 473.36, 473.42
0938-04441004.40, 1004.50, 1004.60, 1004.70
0938-0445412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78
0938-0447405.2133
0938-0448405.2133, 45 CFR 5, 5b; 20 CFR Parts 401, 422E
0938-0449440.180, 441.300-441.310
0938-0454424.20
0938-0456412.105
0938-0463413.20, 413.24, 413.106
0938-0467431.17, 431.306, 435.910, 435.920, 435.940-435.960
0938-0469417.107, 417.478
0938-0470417.143, 417.800-417.840, 422.6
0938-0477412.92
0938-0484424.123
0938-0501406.15
0938-0502433.138
0938-0512486.304, 486.306, 486.307
0938-0526475.102, 475.103, 475.104, 475.105, 475.106
0938-0534410.38, 424.5
0938-0544493.1-493.2001
0938-0564411.32
0938-0565411.20-411.206
0938-0566411.404, 411.406, 411.408
0938-0573412.230, 412.256
0938-0578447.534
0938-0581493.1-493.2001
0938-0599493.1-493.2001
0938-0600405.371, 405.378, 413.20
0938-0610417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102
0938-0612493.801, 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
0938-0618433.68, 433.74, 447.272
0938-0653493.1771, 493.1773, 493.1777
0938-0657405.2110, 405.2112
0938-0658405.2110, 405.2112
0938-0667482.12, 488.18, 489.20, 489.24
0938-0679410.38
0938-0685410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12
0938-0686493.551-493.557
0938-0688486.304, 486.306, 486.307, 486.310, 486.316, 486.318, 486.325
0938-0690488.4-488.9, 488.201
0938-0691412.106
0938-0692466.78, 489.20, 489.27
0938-0701422.152
0938-070245 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 46.180
0938-070345 CFR 148.120, 148.124, 148.126, 148.128
0938-0714411.370-411.389
0938-0717424.57
0938-0721410.33
0938-0722422.370-422.378
Start Printed Page 35650
0938-0723421.300-421.318
0938-0730405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24
0938-0732417.126, 417.470
0938-073445 CFR 5b
0938-0739413.337, 413.343, 424.32, 483.20
0938-0742422.300-422.312
0938-0749424.57
0938-0753422.000-422.700
0938-0754441.152
0938-0758413.20, 413.24
0938-0760484 Subpart E, 484.55
0938-0761484.11, 484.20
0938-0763422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622
0938-0768417.800-417.840
0938-0770410.2
0938-0778422.64, 422.111
0938-0779417.126, 417.470, 422.64, 422.210
0938-0781411.404-411.406, 484.10
0938-0786438.352, 438.360, 438.362, 438.364
0938-0787406.28, 407.27
0938-0790460.12, 460.22, 460.26, 460.30, 460.32, 460.52, 460.60, 460.70, 460.71, 460.72, 460.74, 460.80, 460.82, 460.98, 460.100, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.154, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210
0938-0792491.8, 491.11
0938-0798413.24, 413.65, 419.42
0938-0802419.43
0938-0818410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63
0938-0829422.620, 422.624, 422.626
0938-0832489
0938-0833483.350-483.376
0938-0841431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180
0938-0842412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64
0938-0846411.1, 411.350-411.357, 424.22
0938-0857419
0938-0860419
0938-086645 CFR Part 162
0938-0872413.337, 483.20
0938-0873422.152
0938-087445 CFR Parts 160 and 162
0938-0878422
0938-088345 CFR Parts 160 and 164
0938-088745 CFR 148.316, 148.318, 148.320
0938-0897412.22, 412.533
0938-0907412.230, 412.304, 413.65
0938-0910422.620, 422.624, 422.626
0938-0911426.400, 426.500
0938-0916483.16
0938-0920438.6, 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
End Supplemental Information

[FR Doc. 04-14274 Filed 6-24-04; 8:45 am]

BILLING CODE 4120-01-P