Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2005

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9028-N]

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2005

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 2005 through March 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) 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. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, for the first time, this notice includes a list of Medicare-approved carotid stent facilities.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the

Federal Register

at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

FOR FURTHER INFORMATION CONTACT:

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

Questions concerning items in Addendum III may be addressed to Timothy Jennings, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-2134.

Questions concerning Medicare 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 John Manlove, 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) 786-6877.

Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Jim Wickliffe, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4596.

Questions concerning Medicare-approved carotid stent facilities may be addressed to Rana A. Hogarth, 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) 786-2112; or to Sarah J. McClain, 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) 786-2994.

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, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954.

SUPPLEMENTARY INFORMATION:

I. Program Issuances

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

Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the

Federal Register

. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDA-approved 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 NCD 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 eight 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.

• Addendum VIII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS's standards for performing carotid artery stenting for high risk patients.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New Orders, 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 NCD publication titled “Implantable Automatic Defibrillators,” use CMS-Pub. 100-03, Transmittal No. 29.

(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 20, 2005.

Jacquelyn 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.

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).

June 25, 2004 (69 FR 35634).

September 24, 2004 (69 FR 57312).

December 30, 2004 (69 FR 78428).

February 25, 2005 (70 FR 9338).

Addendum II—Description of Manuals, Memoranda, and CMS Rulings

An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468.

Addendum III.—Medicare and Medicaid Manual Instructions

[January Through March 2005]

Transmittal No.

Manual/subject/publication No.

Medicare General Information (CMS Pub. 100-01)

15

Review of Contractor Implementation of Change Requests (Replacement for expired CR 944).

Review of Contractor Implementation of Change Requests.

CR Implementation Report—Summary Page.

CR Implementation Report—Details Page.

CR Implementation Report—Sample Cover Letter/ Attestation Statement.

16

Standard Terminology for Claims Processing Systems.

17

This Transmittal rescinded and replaced Transmittal 15.

18

Billing for Blood and Blood Products Under the Hospital Outpatient Prospective Payment System.

Items Subject to Blood Deductibles.

Blood.

19

Revisions to Chapter 5, Section 50 of Publication 100-01 in the Internet Only.

Manual to Clarify Current Policy.

Home Health Agency Defined.

Arrangements by Home Health Agencies.

Rehabilitation Centers.

Medicare Benefit Policy (CMS Pub. 100-02)

29

Telehealth Originating Site Facility Fee Payment Amount Update.

30

Policy for Repair and Replacement of Durable Medical Equipment.

Medicare National Coverage Determinations (CMS Pub. 100-03)

27

Infusion Pumps: C-Peptide Levels As A Criterion for Use.

28

Update of Laboratory NCDs to Reference New Screening Benefits.

Blood Glucose Testing.

Lipid Testing.

29

Implantable Automatic Defibrillators.

30

Coverage of Colorectal Anti-Cancer Drugs Included in Clinical Trials.

Anti-Cancer Chemotherapy for Colorectal Cancer (Effective January 28, 2005).

Medicare Claims Processing (CMS Pub. 100-04)

423

January 2005 Update of the Hospital Outpatient Prospective Payment System: Summary of Payment Policy Changes.

424

Implementation of the Annual Desk Review Program for Hospital Wage Data: Cost Reporting Periods Beginning on or After October 1, 2001, Through September 30, 2002 (FY 2006 Wage Index).

425

Section 630 of the Medicare Modernization Act allows for the Reimbursement for Ambulance Services Provided by Indian Health Service/Tribal Hospitals, Including Critical Access Hospitals, Which Manage and Operate Hospital-Based Ambulances.

General Coverage and Payment Policies.

Indian Health Service/Tribal Billing.

426

Modification to Reporting of Diagnosis Codes for Screening Mammography Claims.

Healthcare Common Procedure Coding System and Diagnosis Codes for Mammography Services.

427

Revision of Change Request 2928: Implementation of Payment Safeguards for Home Health Prospective Payment System Claims Failing to Report Prior Hospitalizations.

Adjustments of Episode Payment—Hospitalization Within 14 Days of Start of Care.

428

Update to Billing Requirements for FDG-Positron Emission Tomography Scans For Use in the Differential Diagnosis of Alzheimer's Disease and Fronto-Temporal Dementia and Update to the Fiscal Intermediaries Billing Requirements for Special Payment Procedures for All Positron Emission Tomography Scan.

Claims for Services Performed in a Critical Access Hospital.

Billing Instructions.

Coverage for Positron Emission Tomography Scans for Dementia and Neurodegenerative Disease.

429

Change to the Common Working File Skilled Nursing Facility Consolidated Billing Edits for Critical Access Hospitals That Have Elected Method II Payment Option and Bill Physician Services to Their Fiscal Intermediaries.

Physician's Services and Other Professional Services Excluded From Part A PPS Payment and the Consolidated Billing Requirement.

430

Mandatory Assignment for Medicare Modernization Act § 630 Claims.

Other Part B Services.

Durable Medical Equipment Regional Carrier Drugs.

Claims Processing Requirements for Medicare Modernization Act § 630.

Claims Processing for Durable Medical Equipment Prosthetic, Orthotics & Supplies and Durable Medical Equipment Regional Carrier Drugs.

Enrollment for Durable Medical Equipment Prosthetic, Orthotics & Supplies and Durable Medical Equipment Regional Carrier Drugs.

Enrollment and Billing for Clinical Laboratory and Ambulance Services and Part B Drugs.

Claims Submission and Processing for Clinical Laboratory and Ambulance Services and Part B Drugs.

431

Updated Skilled Nursing Facility No Pay File for April 2005.

432

Adding an Indicator to the National Claims History to Indicate That Durable Medical Regional Carriers, Carriers, and Fiscal Intermediaries Have Reviewed a Potentially Duplicate Claim.

Detection of Duplicate Claims.

433

Issued to a specific audience, not posted to the Internet/Intranet due to the Sensitivity of Instruction.

434

Addition of Clinical Laboratory Improvement Act Edits to Certain Health Care Procedure Coding System Codes for Mohs Surgery.

435

This Transmittal has been rescinded and replaced by Transmittal 450.

436

Remittance Advice Remark Code and Claim Adjustment Reason Code Update.

437

Revisions and Corrections to the Medicare Claims Processing Manual, Chapter 6, Section 30 and Various Sections in Chapter 15.

Billing Skilled Nursing Facility Prospective Payment System Services General Coverage and Payment Policies.

Air Ambulance for Deceased Beneficiary.

General Billing Guidelines for Intermediaries and Carriers.

Intermediary Guidelines.

438

Fiscal Intermediary Standard Paper Remittance Advice Changes.

439

Modification to the Fiscal Intermediary Standard System Regarding Ambulance Services Billed on 18x and 21x Types of Bill.

440

Updating the Common Working File Editing for Pap Smear (Q0091) and Adding a New Low Risk Diagnosis Code (V72.31) for Pap Smear and Pelvic Examination.

Healthcare Common Procedure Coding System Codes for Billing.

Diagnoses Codes.

Payment Method.

Revenue Codes and Healthcare Common Procedure Coding System Codes for Billing.

Medicare Summary Notice Messages.

Remittance Advice Codes.

441

Viable Medicare Systems Changes to Durable Medical Equipment Regional Carrier Processing of Method II Home Dialysis Claims.

442

Hospital Outpatient Prospective Payment System: Use of Modifiers -52, -73 and -74 for Reduced or Discontinued Services

Use of Modifiers.

Use of Modifiers for Discontinued Services.

443

This Transmittal is rescinded and replaced by Transmittal 505.

444

Further Information Related to Inpatient Psychiatric Facility Prospective Payment System

445

Payment to Providers/Suppliers Qualified to Bill Medicare for Prosthetics and Certain Custom-Fabricated Orthotics.

Provider Billing for Prosthetics and Orthotic Services.

446

Diabetes Screening Tests.

447

Common Working File Editing for Method Selection on Durable Medical Equipment Regional Carrier Claims for EPO and Aranesp

Epoetin Alfa Furnished to Home Patients.

Darbepoetin Alfa Furnished to Home Patients.

448

Timeframe for Continued Execution of Crossover Agreements and Update on the Transition to the National Coordination of Benefits Agreement Program

Crossover Claims Requirements.

Fiscal Intermediaries Requirements.

Durable Medical Equipment Regional Carrier Requirements.

Consolidation of the Claims Crossover Process.

Electronic Transmission - General Requirements.

ANSI X12N 837 Coordination of Benefit Transaction Fee Collection.

Medigap Electronic Claims Transfer Agreements.

Intermediary Crossover Claim Requirements.

Carrier/Durable Medical Equipment Regional Carrier Crossover Claims Requirements.

449

April Quarterly Update to 2005 Annual Update of Healthcare Common Procedure Coding System Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement

450

Enforcement of Mandatory Electronic Submission of Medicare Claims

Failure To Furnish Information Medicare Summary Notice Message.

Falta De Information Sometida Medicare Summary Notice Message Enforcement.

451

April 2005 Quarterly Fee Schedule Update for Durable Medical Equipment, Prosthetics, Orhtotics, and Supplies.

452

New Remittance Advice Message for Referred Clinical Diagnostic/ Purchased Diagnostic Service Duplicate Claims.

453

Instructions for Downloading the Medicare Zip Code File.

454

Definitions of Electronic and Paper Claims.

Payment Ceiling Standards.

455

This transmittal is rescinded and replaced by Transmittal 509.

456

Independent Laboratory Billing for the Technical Component of Physician.

Pathology Services Furnished to Hospital Patients (Supplemental to Change Request 3467)

457

Diabetes Screening Tests.

Healthcare Common Procedure Coding System Coding for Diabetes Screening.

Carrier Billing Requirements.

Modifier Requirements for Pre-Diabetes.

Fiscal Intermediary Billing Requirements.

Diagnosis Code Reporting.

Medicare Summary Notices.

Remittance Advice Remark Codes.

Claims Adjustment Reason Codes.

458

Hospice Physician Recertification Requirements.

Data Required on Claim to Fiscal Intermediaries.

459

Full Replacement of Change Request 3427, Transmittal 342, Issued on October 29, 2004—Change to the Common Working File Skilled Nursing Facility.

Consolidated Billing Edits for Ambulance Transports to or From a Diagnostic or Therapeutic Site.

Ambulance Services.

Skilled Nursing Facility Billing.

460

Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction.

461

Processing Durable Medical Equipment, Orthotics, Prosthetics, Drugs, and Surgical Dressings Claims for Indian Health Services and Tribally Owned and Operated Hospitals or Hospital Based Facilities Including Critical Access.

Hospital.

Other Part B Services.

Prosthetics and Orthotics.

Prosthetic Devices.

Surgical Dressings and Splints and Casts.

Drugs Dispensed by IHS Hospital-Based or Freestanding Facilities.

Claims Processing for Durable Medical Equipment Prosthetics, Orthotics & Supplies.

Enrollment for Durable Medical Equipment Prosthetics, Orthotics & Supplies.

Claims Submission for Durable Medical Equipment Prosthetics, Orthotics & Supplies.

462

Durable Medical Equipment Regional Carrier Only—Dispensing Fees for Immunosuppressive Drugs.

463

Update to 100-04 and Therapy Code Lists.

Healthcare Common Procedure Coding System Coding Requirement.

Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility Services—General.

Discipline Specific Outpatient Rehabilitation Modifiers—All Claims.

The Financial Limitation.

Reporting of Service Units With HCPCS—Form CMS-1500 and Form CMS-1450.

464

Implementation of the Abstract File for Purchased Diagnostic.

Test/Interpretations (Supplemental to CR 3481).

Payment Jurisdiction Among Local Carriers for Services Paid Under the Physician Fee Schedule and Anesthesia Services.

Payment Jurisdiction for Purchased Services.

Payment to Physician or Other Supplier for Purchased Diagnostic Tests—Claims Submitted to Carriers.

Payment to Supplier of Diagnostic Tests for Purchased Interpretations.

465

Billing Requirements for Physician Services in Method II Critical Access Hospitals.

Payment for Inpatient Services Furnished by a Critical Access Hospital.

Special Rules for Critical Access Hospital Outpatient Billing.

Billing and Payment in a Physician Scarcity Area.

466

Quarterly Update to Correct Coding Initiative Edits, Version 11.1, Effective April 1, 2005.

467

Modifications to Duplicate Editing for Dispensing/Supply Fee Codes for Oral Anti-Cancer, Oral Anti-Emetic, Immunosuppressive and Inhalation Drugs.

468

Appeals Transition—Benefits, Improvement & Protection Act Section 521.

Appeals.

469

New Waived Tests—April 1, 2005.

470

Standardization of Fiscal Intermediary Use of Group and Claim Adjustment.

Reason Codes and Calculation and Balancing of TS2 and TS3 Segment.

Data Elements.

471

This Transmittal is rescinded and replaced by Transmittal 513.

472

Revisions to Payment for Services Provided Under a Contractual Arrangement—Carrier Claims Only.

Exceptions to Assignment of Provider's Right to Payment—Claims Submitted to Fiscal Intermediaries and Carriers.

Payment for Services Provided Under a Contractual Arrangement—Carrier Claims Only.

473

Use of 12X Type of Bill for Billing Vaccines and Their Administration Bills Submitted to Fiscal Intermediaries.

474

Coordination of Benefits Agreement Detailed Error Report Notification Process.

475

1st Update to the 2005 Medicare Physician Fee Schedule Database.

476

Type of Service Corrections.

477

New Case-Mix Adjusted End-Stage Renal Disease Composite Payment Rates And New Composite Rate Exceptions Window for Pediatric End-Stage Renal Disease Facilities.

Outpatient Provider-Specific File.

Calculation of Case-Mix Adjustment Composite Rate.

Required Information for In-Facility Claims Paid Under the Composite Rate.

478

Clarification of the Verification Process to be Used to Determine If the Inpatient Rehabilitation Facility Meets the Inpatient Rehabilitation Classification Criteria Verification Process To Be Used To Determine If the Inpatient Rehabilitation Facility Met the Classification Criteria.

479

Update to the Healthcare Provider Taxonomy Codes Version 5.0.

480

April 2005 Quarterly Average Sale Price Medicare Part B Drug Pricing File, Effective April 1, 2005, and New January 2005 Quarterly Average Sale Price File.

481

Updated Manual Instructions for the Medicare Claims Processing Manual, Chapter 10.

General Guidelines for Processing Home Health Agency Claims.

Effect of Election of Medicare Advantage Organization and Eligibility Changes on Home Health Prospective Payment System Episodes.

General Guidance on Line Item Billing Under the Home Health Prospective Payment System.

Request for Anticipated Payment.

Home Health Prospective Payment System Claims.

Special Billing Situations Involving Outcome & Assessment Information Set Assessments.

Medical and Other Health Services Not Covered Under the Plan of Care (Bill Type 34X).

482

Manualization of Payment Change for Diagnostic Mammography and Diagnostic Computer Aided Detection.

Screening Mammography Services.

Computer Aided Design Billing Charts.

Payment for Screening Mammography Services Provided Prior to January 1, 2002.

Payment for Screening Mammography Services Provided On and After January 1, 2002.

Outpatient Hospital Mammography Payment Table.

Payment for Computer Add-On Diagnostic and Screening Mammograms for Fiscal Intermediaries and Carriers.

Mammograms Performed With New Technologies.

483

Hospital Partial Hospitalization Services Billing Requirements.

Special Partial Hospitalization Billing Requirements for Hospitals, Community Mental Health Centers, and Critical Access Hospitals.

Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers.

484

New Remittance Advice Message for Referred Clinical Diagnostic/Purchased Diagnostic Service Duplicate Claims.

485

Calculating Payment-to-Cost Ratios for Purposes of Determining Transitional Corridor Payments Under the Outpatient Prospective Payment System.

486

Manualization of Carrier Claims Processing Instructions for Stem Cell Transplantation.

Stem Cell Transplantation.

General.

Healthcare Common Procedure Coding System and Diagnosis Coding.

Non-Covered Conditions.

Edits.

Suggested Medicare Summary Notice and Remittance Advice Messages.

487

Medicare Qualifying Clinical Trials.

Chapter 32, Section 69.0—Qualifying Clinical Trials.

488

This Transmittal has been rescinded and replaced by Transmittal 497.

489

Correction to Healthcare Common Procedure Coding System Code A4217.

Payment of Durable Medical Equipment Prosthetics, Orthotics & Supplies Items Based on Modifiers.

490

Claims Status Code/Claims Status Category Code Update.

Health Care Claims Status Category Codes and Health Care Claims Status Codes for Use With Health Care Claims Status Request and Response ASC X12N 276/277.

491

Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction.

492

Adding an Indicator to the National Claims History to Indicate That Durable Medical Equipment Regional Carrier, Carriers and Fiscal Intermediaries Have Reviewed a Potentially Duplicate Claim.

Detection of Duplicate Claims.

493

Revision to Chapter 1, and Removal of Section 70 from Chapter 25 of the Medicare Claims Processing Manual.

Inpatient Billing From Hospitals and Skilled Nursing Facilities.

Submitting Bills in Sequence for a Continuous Inpatient Stay or Course of Treatment.

Intermediary Processing of No-Payment Bills.

Time Limitations for Filing Provider Claims to Fiscal Intermediaries.

Statement of Intent.

Filing Request for Payment to Carriers—Medicare Part B.

Fiscal Intermediary Consistency Edits.

Patient is a Member of a Medicare Advantage Organization for Only a Portion of the Billing Period.

Late Charges.

Inpatient Part A Hospital Adjustment Bills.

494

April 2005 Outpatient Prospective Payment System Code Editor Specifications Version 6.1.

495

Inpatient Psychiatric Facility Prospective Payment System—Further Clarifications.

496

Billing for Blood and Blood Products Under the Hospital Outpatient Prospective Payment System.

When a Provider Paid Under the Outpatient Prospective Payment System Does Not Purchase the Blood or Blood Products That It Procures From a Community Blood Bank, or When a Provider Paid Under the Outpatient Prospective Payment System Does Not Assess a Charge for Blood or Blood Products Supplied by the Provider's Own Blood Bank Other Than Blood Processing and Storage.

When a Provider Paid Under the Outpatient Prospective Payment System Purchases Blood or Blood Products from a Community Blood Bank or When a Provider Paid Under the Outpatient Prospective Payment System Assesses a Charge for Blood or Blood Products Collected by Its Own Blood Bank That Reflects More Than Blood Processing and Storage.

Billing for Autologous Blood (Including Salvaged Blood) and Directed Donor Blood.

Billing for Split Unit of Blood.

Billing for Irradiation of Blood Products.

Billing for Frozen and Thawed Blood and Blood Products.

Billing for Unused Blood.

Billing for Transfusion Services.

Billing for Pheresis and Apheresis Services.

Correct Coding Initiative Edits.

Blood Products and Drugs Classified in Separate Average Projected Costs for Hospital Outpatients.

497

Billing for Implantable Automatic Defibrillators for Beneficiaries in a Medicare Advantage Plan and Use of the Quarterly Refund Modifier to Identify Patient Registry Participation.

498

Billing of the Diagnosis and Treatment of Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes.

General Billing Requirements.

Applicable Healthcare Common Procedure Coding System Codes.

Diagnosis Codes.

Payment.

Applicable Revenue Codes.

Editing Instructions for Fiscal Intermediaries.

Common Working File General Information.

Common Working File Utilization Edits.

499

2005 Scheduled Release for April Updates to Software Programs and Pricing/Coding Files.

500

Changes to the Laboratory National Coverage Determination Edit.

Software for April 2005.

501

Bone Mass Measurements—Procedure Coding.

502

New Contrast Agents Healthcare Common Procedure Coding System Codes.

503

April Update to the Medicare Non-Outpatient Prospective Payment Systems.

Outpatient Code Editor Specification Version 20.2.

504

Update to Pub 100-04, Chapter 12, Section 200 of the Internet Only Manual.

Allergy Testing and Immunotherapy.

505

Unprocessable Unassigned Form CMS-1500 Claims.

Incomplete or Invalid Claims Processing Terminology.

506

Updated Manual Instructions for Item 24G (Days or Units), Chapter 26.

507

New Healthcare Common Procedure Coding System for Intravenous Immune Globulin.

508

This Transmittal is rescinded and replaced by Transmittal 514.

509

Number of Drug Pricing Files That Must Be Maintained Online for Medicare—Durable Medical Equipment Regional Carriers Only.

Online Pricing Files for Average Sales Price.

510

Update to Fiscal Year 2005 Pricer for IPPS Hospitals.

511

Type of Service Corrections.

512

Coverage of Colorectal Anti-Cancer Drugs Included in Clinical Trials.

513

Infusion Pumps: C-Peptide Levels As a Criterion for Use.

514

April 2005 Update of the Hospital Outpatient Prospective Payment System: Summary of Payment Policy Changes.

Medicare Secondary Payer (CMS Pub. 100-05)

23

Modification to Online Medicare Secondary Payer Questionnaire.

Admission Questions to Ask Medicare Beneficiaries.

24

Issued to a specific audience, not posted to Internet/Intranet, due to Sensitivity of Instruction.

25

Update Medicare Secondary Payer Manual Publication 100-05 to reflect Statutory Changes included in the Medicare Modernization Act.

General Provisions.

Conditional Primary Medicare Benefits.

When Conditional Primary Medicare Benefits May Be Paid.

When Medicare Secondary Benefits Are Payable and Not Payable.

Definitions.

Beneficiary's Rights and Responsibility.

Statutory Provisions.

No-Fault Insurance.

Situations in Which Medicare Secondary Payer Billing Applies.

Incorrect Group Health Plan Primary Payments.

General Policy.

Conditional Primary Medicare Benefits.

Conditional Medicare Payment.

Medicare Right of Recovery.

Conflicting Claims by Medicare and Medicaid.

Third Party Payer Refund Requests Served on Medicare.

General Operational Instructions.

Conditional Primary Medicare Benefits.

Existence of Overpayment.

26

Clarification for Change Request (CR) 3267.

General Policy.

27

Updates to the Electronic Correspondence Referral System User Guide v8.0 and Quick Reference Card v8.0.

Coordination of Benefits Contractor Electronic Correspondence Referral System.

Providing Written Documents to the Coordination of Benefits Contractor.

Medicare Financial Management (CMS Pub. 100-06)

55

Reporting Appeals Redetermination Information on Forms CMS-2591 and 2590.

56

Revision to Balancing Requirement on Form 5, Line 10, of the Contractor.

Reporting of Operational and Workload Data.

57

Revised Reporting Requirements for Contractor Reporting of Operational Workload Data Health Professional Shortage Area Quarterly Report.

58

Issued to specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.

59

Notice of New Interest Rate for Medicare Overpayments and Underpayments.

60

Revised instructions on contractor procedures for provider audit and the Provider.

Statistical & Reimbursement Report.

Submission of Cost Report Data to CMS.

Desk Review Exceptions Resolution Process.

Definition of Field Audits.

Purpose of Field Audits.

Establishing the Objective/Scope of the Field Audit.

Audit Confirmation Letter.

Entrance Conference.

Tests of Internal Control.

Designing Tests/Sampling.

Pre-Exit Conference.

Finalization of Audit Adjustments.

Exit Conference.

Medicare Cost Report and All Related Documents.

Qualifications.

Internal Quality Control.

Final Settlement of the Cost Report.

Audit Responsibility When Provider Changes Contractors.

Audits of Home Offices.

Standards for Issuance of an Audit Report for a Home Office.

Provider Permanent File.

Contractor Responsibility in Suspected Fraud or Abuse Cases.

61

New Location Code Interstate Commerce Commission, Status Code AR and Modified Intent Letter for Unfiled Cost Reports Only.

Recovery of Overpayment Due to Overdue Cost Report.

Provider Overpayment Recovery System User Manual.

List of Status Codes.

Content of Demand Letters-Fiscal Intermediary Serviced Providers.

62

Timeframe for Continued Execution of Crossover Agreements and Updated on the Transition to the National Coordination of Benefits Agreement Program.

Coordination of Medicare and Complementary Insurance Programs.

63

Notice of New Interest Rate for Medicare Overpayments and Underpayments.

64

For Fiscal Intermediaries, a New Provider Type 80, Status Code CH, and Method of Recoupment Codes. For Carriers and Durable Medical Equipment.

Regional Carriers Status Code 2.

Provider Overpayment Reporting System User Manual.

List of Status Codes.

Physician/Supplier Overpayment Reporting System User Manual.

65

Revised Reporting Requirements for Contractor Reporting of Operational Workload Data Physician Scarcity Area Quarterly Report (CMS Form—1565F, CROWD Form6).

Completing Physician Scarcity Area Quarterly Report Form CMS 1565F, CROWD Form 6.

Physician Scarcity Area Quarterly Report, Line Descriptors.

Error Descriptors.

Checking Reports.

66

Chapter 7, Internal Control Requirements Update.

Federal Managers' Financial Integrity Act of 1982.

Federal Managers Financial Integrity Act and the CMS Medicare Contractor Contract.

Chief Financial Officers Act of 1990.

Office of Management & Budget Circular A-123.

General Accounting Office Standards for Internal Controls in the Federal Government.

Fundamental Concepts.

Control Activities.

Monitoring.

Risk Assessment.

Internal Control Objectives.

Fiscal Year 2005 Medicare Control Objectives.

Policies and Procedures.

Control Activities.

Testing Methods.

Documentation and Working Papers.

Requirements.

Certification Statement.

Executive Summary.

Certification Package for Internal Controls Report of Material Weaknesses.

Certification Package for Internal Controls Report of Reportable Conditions.

Definitions and Examples of Reportable Conditions and Material Weaknesses.

Material Weaknesses Identified During the Fiscal Year.

Corrective Action Plans.

Submission, Review, and Approval of Corrective Action Plans.

Corrective Action Plan Reports.

CMS Finding Numbers.

Initial Corrective Action Plan Report.

Quarterly Corrective Action Plan Report.

Entering Data: Initial or Quarterly Corrective Action Plan Report.

Medicare State Operations Manual (CMS Pub. 100-07)

00

None

Medicare Program Integrity (CMS Pub. 100-08)

)

93

This Transmittal has been rescinded and replaced by Transmittal 102.

94

Informing Beneficiaries About Which Local Medical Review Policy and/or Local Coverage Determination and/or National Coverage.

Determination Is Associated With Their Claim Denial.

Prepayment Edits.

95

Change in Provider Enrollment Appeals Process.

Administrative Appeals.

96

Consent Settlements.

Postpayment Review Case Selection.

Location of Postpayment Reviews.

Re-adjudication of Claims.

Calculation of the Correct Payment Amount and Subsequent Over/Underpayment.

Notification of Provider(s) or Supplier(s) and Beneficiaries of the Postpayment Review Results.

Provider(s) or Supplier(s) Rebuttal(s) of Findings.

Evaluation of the Effectiveness of Postpayment Review and Next Steps.

Consent Settlement Instructions.

Background on Consent Settlement.

Opportunity to Submit Additional Information Before Consent Settlement Offer.

Consent Settlement Offer.

Election to Proceed to Statistical Sampling for Overpayment Estimation.

Acceptance of Consent Settlement Offer.

Consent Settlement Budget and Performance Requirements for Medicare Contractors.

97

Provider Enrollment and Inpatient Rehabilitation Facility (IRF) Compliance Reviews.

98

Psychotherapy Notes.

Additional Documentation Requests During Prepayment or Postpayment Medical Review.

99

Program Integrity Manual Modification—Changes Waivers Approved by the Regional Office by Replacing Regional Office With Central Office.

Contractor Medical Director.

Benefit Integrity Security Requirements.

The Carrier Advisory Committee.

100

Review of Documentation During Medical Review.

Additional Documentation Requests During Prepayment or Postpayment Medical Review.

Documentation in the Patient's Medical Records.

101

Benefit Integrity Personal Information Manager Revisions.

Sources of Data for Program Safeguard Contractors.

Procedural Requirements.

Benefit Integrity Security Requirements.

Requests for Information From Outside Organizations.

Program Safeguard Contractor and Medicare Contractor Coordination With Other Program.

Safeguard Contractors and Medicare Contractors.

Complaint Screening.

Types of Fraud Alerts.

Alert Specifications.

Editorial Requirements.

Coordination.

Distribution of Alerts.

Information Not Captured in the Fraud Investigation Database.

Initial Entry Requirements for Investigations.

Designated Program Safe Guard and Medicare Contractor Background Investigation.

Unit Staff and the Fraud Investigation Database.

Affiliated Contractor and Program Safeguard Contractor Coordination on Voluntary Refunds.

Referral of Cases to the Office of the Inspector General/Office of Investigations.

Referral to State Agencies or Other Organizations.

Civil Monetary Penalties Delegated to Office of the Inspector General.

Annual Deceased-Beneficiary Postpayment Review.

Vulnerability Report.

102

Medical Review of Rural Air Ambulance Services.

“Reasonable” Requests.

Emergency Medical Services Protocols.

Prohibited Air Ambulance Relationships.

Reasonable and Necessary Services.

Definition of Rural Air Ambulance Services.

103

Discontinuation of Medical Review Reports—The Medicare Status Report.

Report of Benefit Savings, Medicare Focused Medical Review Status Report, and Focused Medical Review Report.

104

Requirement that Medicare Carrier System Not Allow the Re-review of Previously Denied Claims.

Contractor Administrative Budget & Financial Management II Reporting for Medical Review Activities.

105

The Medically Unbelievable Edits.

106

Inclusion of Interventional Pain Management Specialists on Carrier Advisory Committee Membership Physicians.

Medicare Contractor Beneficiary and Provider Communications (CMS Pub. 100-09)

08

Medicare Beneficiary Call Centers Will Begin Offering Preventive Services Information.

Promote Medicare Preventive Services.

Medicare Managed Care (CMS Pub. 100-16)

65

Surveys, Contracting Strategy, and Appeals.

Medicare Business Partners Systems Security (CMS Pub. 100-17)

00

None.

Demonstrations (CMS Pub. 100-19)

15

Issued to a specific audience, not posted to Internet/Intranet due to the Confidentiality of Instruction

16

Issued to a specific audience, not posted to Internet/Intranet due to the Sensitivity of Instruction.

17

Demonstration Project for Medical Adult Day-Care Services.

18

Demonstration Project to Clarify the Definition of Homebound, the Home Health Independence Demonstration.

19

Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction.

20

Full Replacement of CR 3220, Method of Reimbursement for Inpatient Services for Rural Hospital Participating Under Demonstration Authorized by Section 410A of the Medicard Modernization Act, CR 3220 Is Rescinded.

21

Full Replacement of CR 3639, Expansion of Coverage for Chiropractic Services Demonstration.

One Time Notification (CMS Pub. 100-20)

134

Revisions to January 2005 Quarterly Average Sales Price Medicare Part B Drug Pricing File.

135

Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing.

136

Medlearn Matters Article Related to the Flu Demonstration.

137

Instruction to Contractors Regarding Aged, Pre-settlement Cases and Inter-Contractor Notices.

138

Production of Provider Flat Files, Including Taxpayer Identification Numbers, From the Fiscal Intermediary Standard System, Financial Master Files.

139

Update to the Evaluation Plan for the CD-Rom Initiative Used in the Mailing of 2005 Annual Participation Enrollment Material.

140

Revisions to January 2005 Quarterly Average Sales Price Medicare Part B Drug Pricing File.

141

Shared System and Common Working File Renovation of Override Code Process (Phase 3).

142

This Transmittal Is Rescinded and Will Not Be Replaced at this Time.

143

Shared System Maintainer Hours to Begin Work and Analysis on the Implementation of the National Provider Identifier—FOR ANALYSIS ONLY.

144

Debt Collection Improvement Act Backlog Non-Medicare Secondary Payor Collections From February 1998 to September 2004.

145

Frequent Hemodialysis Network Payment Changes for Approved Clinical Trial Costs.

146

Appeals Transition—BIPA Section 521 Appeals.

Addendum IV.—Regulation Documents Published in the

Federal Register

January Through March 2005

Publication date

FR Vol. 70 page No.

CFR parts affected

File code

Title of regulation

January 19, 2005

3036

CMS-2230-NC

State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2002.

January 28, 2005

4588

417 and 422

CMS-4069-F

Medicare Program; Establishment of the Medicare Advantage Program.

January 28, 2005

4194

400, 403, 411, 417, and 423

CMS-4068-F

Medicare Program; Medicare Prescription Drug Benefit.

January 28, 2005

4133

CMS-3150-N

Medicare Program; Meeting of the Medicare Coverage Advisory Committee—March 29, 2005.

January 28, 2005

4132

CMS-5033-N2

Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services.

January 28, 2005

4130

CMS-5037-N

Medicare Program; Demonstration of Coverage of Chiropractic Services Under Medicare.

January 28, 2005

4129

CMS-4079-N

Medicare Program; Re-Chartering of the Advisory Panel on Medicare Education (APME) and Notice of the APME Meeting—February 24, 2005.

February 3, 2005

5724

412

CMS-1483-P

Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates, Policy Changes, and Clarification.

February 4, 2005

6526

423

CMS-0011-P

Medicare Program; E-Prescribing and the Prescription Drug Program.

February 4, 2005

6184

400, 405, 410, 412, 413, 414, 488, and 494

CMS-3818-P

Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities

February 4, 2005

6140

405, 482, and 488

CMS-3835-P

Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants.

February 4, 2005

6086

413, 441, 486, and 498

CMS-3064-P

Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs).

February 4, 2005

6014

CMS-1366-N

Medicare Program; Meeting of the Practicing Physicians Advisory Council—March 7, 2005.

February 4, 2005

6013

CMS-1299-N

Medicare Program; Monthly Payment Amounts for Oxygen and Oxygen Equipment for 2005, in Accordance with Section 302(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

February 4, 2005

6012

CMS-3155—N

Medicare Program; Quality Improvement Organization Contracts: Solicitation of Statements of Interest From In-State Organizations—Alaska, Hawaii, Idaho, Maine, South Carolina, Vermont, and Wyoming.

February 25, 2005

9362

CMS-4089-N

Medicare Program; Meeting of the Advisory Panel on Medicare Education—March 22, 2005.

February 25, 2005

9360

CMS-4088-N

Medicare Program; Part D Reinsurance Payment Demonstration.

February 25, 2005

9358

CMS-1219-N

Medicare Program; Changes in Geographical Boundaries of Durable Medical Equipment Regional Service Areas.

February 25, 2005

9355

CMS-3119-FN

Medicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services.

February 25, 2005

9338

CMS-9025-N

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2004.

February 25, 2005

9337

CMS-5011-WN2

Medicare and Medicaid Programs; Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE); Cancellation of Withdrawal.

February 25, 2005

9336

CMS-1296-N

Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups.

February 25, 2005

9232

421

CMS-1219-F

Medicare Program; Durable Medical Equipment Regional Carrier Service Areas and Related Matters.

March 4, 2005

10746

414

CMS-1325-P

Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B.

March 4, 2005

10645

CMS-4089-N2

Medicare Program; Meeting of Advisory Panel on Medicare Education—March 22, 2005: Location Change.

March 8, 2005

11420

401 and 405

CMS-4064-IFC

Medicare Program; Changes to the Medicare Claims Appeal Procedures.

March 11, 2005

12691

CMS-1269-N3

Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting and Announcement of Members.

March 21, 2005

13401

417 and 422

CMS-4069-F2

Medicare Program; Establishment of the Medicare Advantage Program; Interpretation.

March 21, 2005

13397

400, 403, 411, 417, and 423

CMS-4068-F2

Medicare Program; Medicare Prescription Drug Benefit; Interpretation.

March 25, 2005

15394

CMS-4080-N

Medicare Program; Recognition of NAIC Model Standards for Regulation of Medicare Supplemental Insurance.

March 5, 2005

15343

CMS-5033-N3

Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services.

March 25, 2005

15341

CMS-3151-N

Medicare Program; Meeting of the Medicare Coverage Advisory Committee—May 24, 2005.

March 25, 2005

15340

CMS-1297-N

Medicare Program; Public Meetings in Calendar Year 2005 for All New Public Requests for Revisions to the Healthcare Common Procedures Coding System (HCPS) Coding and Payment Determinations.

March 25, 2005

15337

CMS-3112-FN

Medicare Program; Disapproval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers.

March 25, 2005

15335

CMS-2256-FN

Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Community Health Accreditation Program (CHAP) for Home Health Agencies.

March 25, 2005

15333

CMS-2208—FN

Medicare and Medicaid Programs; Recognition of the American Osteopathic Association (AOA) for Continued Approval of Deeming Authority for Hospitals.

March 25, 2005

15331

CMS-2204-FN

Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies.

March 25, 2005

15329

CMS-0014-N

Procedures for Non-Privacy Administrative Simplification Complaints Under the Health Insurance Portability and Accountability Act of 1996.

March 25, 2005

15324

CMS-2211-N

Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogentics as a CLIA Accreditation Organization.

March 25, 2005

15266

482

CMS-3122-P

Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations.

March 25, 2005

15265

413, 441, 486, and 498

CMS-3064-N

Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs); Extension of Comment Period.

March 25, 2005

15264

405, 482, and 488

CMS-3835-N

Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants; Extension of Comment Period.

March 25, 2005

15229

403, 416, 418, 460, 482, 483, and 485

CMS-3145-IFC

Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Amendment.

Addendum V.—National Coverage Determinations [January Through March 2005]

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 Through March 2005]

Title

NCDM section

TN No.

Issue date

Effective date

Infusion Pumps: C-Peptide Levels as a Criterion for Use

280.14

R27NCD

02/04/05

12/17/04

Update of Laboratory NCDs to Reference New Screening Benefits

190.20/190.23

R28NCD

02/11/05

01/01/05

Implantable Automatic Defibrillators

20.4

R29NCD

03/04/05

01/27/05

Anti-Cancer Chemotherapy for Colorectal Cancer

110.17

R30NCD

03/29/05

01/28/05

Addendum VI. FDA-Approved Category B IDEs [January Through March 2005]

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 non-experimental 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 first quarter, January through March 2005.

IDE

Category

G030069

G040051

G040161

G040166

G040195

G040196

G040218

G040219

G040224

G040227

G040228

G040230

G040232

G040233

G050001

G050004

G050009

G050011

G050018

G050019

G050021

G050022

G050024

G050026

G050029

G050034

G050038

G050043

G050045

Addendum VII.—Approval Numbers for Collections of Information

Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:

OMB control Nos.

Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by “45 CFR,” and sections in Title 20 are preceded by “20 CFR”)

0938-0008

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

0938-0050

413.20, 413.24

0938-0062

431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5

0938-0065

485.701-485.729

0938-0074

491.1-491.11

0938-0080

406.7, 406.13

0938-0086

420.200-420.206, 455.100-455.106

0938-0101

430.30

0938-0102

413.20, 413.24

0938-0107

413.20, 413.24

0938-0146

431.800-431.865

0938-0147

431.800-431.865, 493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455

0938-0151

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

0938-0301

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

489.11, 489.20

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

442.30, 488.26

0938-0382

442.30, 488.26

0938-0386

405.2100-405.2171

0938-0391

488.18, 488.26, 488.28

0938-0426

476.104, 476.105, 476.116, 476.134

0938-0429

447.53

0938-0443

473.18, 473.34, 473.36, 473.42

0938-0444

1004.40, 1004.50, 1004.60, 1004.70

0938-0445

412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78

0938-0447

405.2133

0938-0448

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

417.126, 422.502, 422.516

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, 146.180

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

0938-0723

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

441.151, 441.152

0938-0758

413.20, 413.24

0938-0760

Part 484 subpart E, 484.55

0938-0761

484.11, 484.20

0938-0763

422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622

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

422.568

0938-0832

Parts 489 and 491

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

411.352-411.361

0938-0857

Part 419

0938-0860

Part 419

0938-0866

45 CFR part 162

0938-0872

413.337, 483.20

0938-0873

422.152

0938-0874

45 CFR parts 160 and 162

0938-0878

Part 422 subpart F & G

0938-0883

45 CFR parts 160 and 164

0938-0884

405.940

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, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.710, 438.722, 438.724, 438.810

0938-0921

414.804

0938-0931

45 CFR part 142.408, 162.408, and 162.406

0938-0933

438.50

0938-0934

403.766

0938-0936

423

0938-0940

484 and 488

0938-0944

422.250, 422.252, 422.254, 422.256, 422.258, 422.262, 422.264, 422.266, 422.270, 422.300, 422.304, 422.306, 422.308, 422.310, 422.312, 422.314, 422.316, 422.318, 422.320, 422.322, 422.324, 423.251, 423.258, 423.265, 423.272, 423.279, 423.286, 423.293, 423.301, 423.308, 423.315, 423.322, 423.329, 423.336, 423.343, 423.346, 423.350

Addendum VIII—Medicare-Approved Carotid Stent Facilities (January Through March 2005)

On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients.

Facility

Provider No.

Effective date

1. Advocate Christ Medical Center, 4440 West 95th Street, Oak Lawn, IL 60453

140208

05/03/2005

2. Advocate Lutheran General Hospital, 1775 Dempster Street, Park Ridge, IL 60068

140223

05/05/2005

3. Aiken Regional Medical Centers, 302 University Parkway, P.O. Drawer 1117, Aiken, SC 29802-1117

420082

05/10/2005

4. Akron General Medical Center, 400 Wabash Avenue, Akron, OH 44266

360027

05/16/2005

5. Albany Medical Center Hospital, 43 New Scotland Avenue, Albany, NY 12208

330013

05/16/2005

6. Alexian Brothers Medical Center, 800 W. Biesterfied Road, Elk Grove Village, IL 60007

140258

04/18/2005

7. Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212-4772

390050

05/11/2005

8. Arizona Heart Hospital, 1930 E. Thomas Road, Phoenix, AZ 85016

030102

04/18/2005

9. Aspirus Wausau Hospital, Inc, 333 Pine Ridge Boulevard, Wausau, WI 54401

520030

05/10/2005

10. Aurora Sinai Medical Center, 945 N. 12th Street, Milwaukee, WI 53201

520064

05/03/2005

11. Avera Heart Hospital of South Dakota, 4500 West 69th Street, Sioux Falls, SD 57108

430095

05/05/2005

12. Bakersfield Heart Hospital, 3001 Sillect Avenue, Bakersfield, CA 93308

050724

05/25/2005

13. Bakersfield Memorial Hospital, 420 34th Street, Bakersfield, CA 93301

050036

05/23/2005

14. The Baldwin County Eastern Shore Health Care Authority, d/b/a Thomas Hospital, 750 Morphy Avenue, Fairhope, AL 36532

010100

04/07/2005

15. Banner Good Samaritan Medical Center, 1111 E. McDowell Road, Phoenix, AZ 85006

030002

05/23/2005

16. Baptist Hospital East, 4000 Kresge Way, Louisville, KY 40207

180130

04/12/2005

17. Baptist Hospital of East Tennessee, 137 Blount Avenue, Knoxville, TN 37920

440019

04/12/2005

18. Baptist Hospital-Pensacola, 1000 West Moreno Street, Post Office Box 17500, Pensacola, FL 32522-7500

100093

04/27/2005

19. Baptist Medical Center, 1225 North State Street, Jackson, MS 39202

250102

05/05/2005

20. Baptist Medical Center South, 2105 East South Boulevard, P.O. Box 11010, Montgomery, AL 36111-0010

010023

04/20/2005

21. Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, TN 38120

440048

04/18/2005

22. Baptist Memorial Hospital-DeSoto, 7601 Southcrest Parkway, Southaven, MS 38671

250141

05/05/2005

23. Baptist Montclair Medical Center, 800 Montclair Road, Birmingham, AL 35213

010104

04/26/2005

24. Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, St. Louis, MO 63110

260032

05/05/2005

25. Bay Medical Center, 615 North Bonita Avenue, Panama City, FL 32401

100026

05/23/2005

26. Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199

220077

05/16/2005

27. Benefis Healthcare, 1101 26th Street South, Great Falls, MT 59405

270012

05/26/2005

28. Bethesda Hospital, 10500 Montgomery Road, Cincinnati, OH 45242-9508

360179

05/05/2005

29. Blanchard Valley Regional Health Center, 145 West Wallace Street, Findlay, OH 45840

360095

05/26/2005

30. Borgess Medical Center, 1521 Gull Road, Kalamazoo, MI 49048

020117

04/12/2005

31. Bon Secours St. Mary's Hospital, 5801 Bremo Road, Richmond, VA 23226

490059

04/01/2005

32. Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115

220110

05/16/2005

33. Caritas St. Elizabeth's Medical Center, 736 Cambridge Street, Boston, MA 02135-2997

220036

04/26/2005

34. Cascade Healthcare Community, Dba: St Charles Medical Center Bend, 2500 NE. Neff Road, Bend, OR 97701

380040

05/03/2005

35. Central Baptist Hospital, 1740 Nicholasville Road, Lexington, KY 40503

180103

04/27/2005

36. Central Dupage Hospital, 25 North Winfield Road, Winfield, IL 60190

140242

05/26/2005

37. Central Georgia Health Systems, dba The Medical Center of Central Georgia, 777 Hemlock Street, Macon, GA 31208

110107

05/11/2005

38. Charleston Area Medical Center, 3200 MacCorkle Avenue, SE, Charleston, WV 25304

510022

04/27/2005

39. Charlotte Regional Medical Center, 809 East Marion Avenue, Punta Gorda, FL 33950

100047

05/11/2005

40. [The] Christ Hospital, 2139 Auburn Avenue, Cincinnati, OH 45219

360163

05/26/2005

41. Christiana Care Health Services, 4755 Ogletown-Stanton Road, P.O. Box 6001, Newark, DE 19718-6001

080001

05/23/2005

42. CHRISTUS St. Frances Cabrini Hospital, 3330 Masonic Drive, Alexandria, LA 71301

190019

04/18/2005

43. CJW Medical Center, Chippenham Hospital, 7101 Jahnke Road, Richmond, VA 23225

490112

05/03/2005

44. Clarian Health Partners, Inc, I-65 at 21st Street, P.O. Box 1367, Indianapolis, IN 46206-1367

150056

05/23/2005

45. Clear Lake Regional Medical Center, 500 Medical Center Blvd, Webster, TX 77598

450617

04/01/2005

46. The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195

360180

04/12/2005

47. College Station Medical Center, 1604 Rock Prairie Road, College Station, TX 77845

450299

05/25/2005

48. Community Health Partners, 3700 Kolbe Road, Lorain, OH 44053-1697

360172

05/23/2005

49. Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756

300003

04/27/2005

50. Deaconess Medical Center, PO Box 248, Spokane, WA 99210-0248

500044

05/10/2005

51. Doylestown Hospital, 595 West State Street, Doylestown, PA 18901

390203

04/27/2005

52. Eastern Maine Medical Center, 489 State Street, P.O. Box 404, Bangor, ME 04402-404

200033

04/18/2005

53. El Camino Hospital, 2500 Grant Road, P.O. Box 7025, Mountain View, CA 94039-7025

050308

05/10/2005

54. Eliza Coffee Memorial Hospital, P.O. Box 818, Florence, AL 35631

010006

05/05/2005

55. EMH Regional Medical Center, 630 East River Street, Elyria, OH 44035

360145

05/23/2005

56. Emory Crawford Long Hospital, 550 Peachtree Street, NE, Atlanta, GA 30308-2225

110078

05/16/2005

57. Emory University Hospital, 1364 Clifton Road, NE, Atlanta, GA 30322

110010

04/04/2005

58. Erlanger Health System, 975 East Third Street, Chattanooga, TN 37403

440104

05/23/2005

59. Evanston Hospital, 2650 Ridge Avenue, Evanston, IL 60201

140010

03/30/2005

60. Exempla St. Joseph Hospital, 1835 Franklin Street, Denver, CO 80218-1191

060009

05/10/2005

61. Fletcher Allen Health Care, Medical Center Campus, 111 Colchester Avenue, Burlington, VT 05401-1473

470003

05/26/2005

62. Forsyth Medical Center, 3333 Silas Creek Parkway, Winston Salem, NC 27103

340014

04/20/2005

63. Fort Sanders Regional Medical Center, 1901 W. Clinch Avenue, Knoxville, TN 37916-2398

440125

05/11/2005

64. Fort Walton Beach Medical Center, 1000 Mar Walt Drive, Fort Walton Beach, FL 32547

100223

04/14/2005

65. Fresno Heart Hospital, 15 E. Audubon Drive, Fresno, CA 93720

050732

04/26/2005

66. Fountain Valley Regional Hospital and Medical Center, 17100 Euclid Street, P.O. Box 8010, Fountain Valley, CA 92708

050570

04/26/2005

67. Galichia Heart Hospital, 2610 N. Woodlawn, Wichita, KS 67220-2729

170192

05/16/2005

68. Geisinger Medical Center, 100 North Academy Avenue, Danville, PA 17822

390006

05/05/2005

69. Geisinger Wyoming Valley Medical Center, 1000 East Mountain Boulevard, Wilkes-Barre, PA 18711

390270

05/05/2005

70. Good Samaritan Hospital, 1225 Wilshire Boulevard, Los Angeles, CA 90017

050471

04/12/2005

71. Good Samaritan Hospital, 2425 Samaritan Drive, San Jose, CA 95124

050380

04/12/2005

72. Good Samaritan Hospital, 255 Lafayette Avenue, Suffern, NY 10901

330158

04/27/2005

73. Good Samaritan Hospital, 2222 Philadelphia Drive, Dayton, OH 45406-1891

360052

05/25/2005

74. Good Samaritan Hospital, 375 Dixmyth Avenue, Cincinnati, OH 45220-489

360134

04/18/2005

75. Grandview Hospital and Medical Center, 405 Grand Avenue, Dayton, OH 45405

360133

05/05/2005

76. Greater Baltimore Medical Center, 6701 N. Charles Street, Baltimore, MD 21204

210044

05/11/2005

77. Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601

310001

04/27/2005

78. Hahnemann University Hospital/Tenet, 230 N. Broad Street, Mailstop 119, Philadelphia, PA 19102-1192

390290

05/10/2005

79. Hamot Medical Center, 201 State Street, Erie, PA 16550

390063

05/05/2005

80. Harbor-UCLA Medical Center, 1000 West Carson Street, Torrance, CA 90502

050376

04/12/2005

81. Harper-Hutzel Hospital, 3990 John R Street, Detroit, MI 48201

230104

04/19/2005

82. Harris Methodist Fort Worth Hospital, 1301 Pennsylvania Avenue, Fort Worth, TX 76104

450135

04/20/2005

83. Harris Methodist HEB, 1600 Hospital Parkway, Bedford, TX 76022

450639

05/16/2005

84. Hartford Hospital, 80 Seymour Street, P.O. Box 5037, Hartford, CT 06102-5037

070025

05/23/2005

85. Hays Medical Center, 2220 Canterbury Road, Hays, KS 67601

170013

05/23/2005

86. Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415-1829

240004

05/16/2005

87. Hialeah Hospital, 651 East 25th Street, Hialeah, FL 33013

100053

05/05/2005

88. High Point Regional Health System, 601 North Elm Street, P.O. Box HP-5, High Point, NC 27261

340004

05/16/2005

89. Hillcrest Hospital, 6780 Mayfield Road, Mayfield Hts., OH 44124

360230

05/16/2005

90. Hoag Memorial Hospital Presbyterian, One Hoag Drive, Newport Beach, CA 92663

050224

04/04/2005

91. Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104

390111

05/23/2005

92. Hunterdon Medical Center, 2100 Wescott Drive, Flemington, NJ 08822

310005

04/12/2005

93. Huntington Hospital, 100 W. California Boulevard, P.O. Box 7013, Pasadena, CA 91109-7013

050438

05/05/2005

94. Iowa Methodist Medical Center, 1200 Pleasant Street, Des Moines, IA 50309

160082

04/18/2005

95. Irvine Regional Hospital & Medical Center, 16200 Sand Canyon Avenue, Irvine, CA 92618

050693

05/10/2005

96. Jewish Hospital, 200 Abraham Flexner Way, Louisville, KY 40202

180040

04/12/2005

97. John Muir Medical Center, 1601 Ygnacio Valley Road, Walnut Creek, CA 94598-3194

050180

05/10/2005

98. Jupiter Medical Center, 1210 S. Old Dixie Hwy, Jupiter, FL 33458

100253

04/20/2005

99. Kaleida Health, Millard Fillmore Hospital, 3 Gates Circle, Buffalo, NY 14209

330005

05/03/2005

100. Kansas Heart Hospital, 3601 N. Webb Road, Wichita, KS 67226

170186

05/23/2005

101. Kent Hospital, 455 Toll Gate Road, Warwick, RI 02886

410009

04/20/2005

102. Kettering Medical Center, 3535 Southern Blvd, Kettering, OH 45429

360079

05/05/2005

103. King's Daughters Medical Center, 2201 Lexington Avenue, Ashland, KY 41101

180009

05/23/2005

104. Lakeland Hospital, 1234 Napier Avenue, St. Joseph, Mi 49085

230021

04/04/2005

105. Lakeland Regional Medical Center, 1324 Lakeland Hills Boulevard, Lakeland, FL 33805

100157

05/25/2005

106. Lakeview Regional Medical Center, 95 E. Fairway Drive, Covington, LA 70433

190177

05/03/2005

107. Lawnwood Medical Center, Inc, d/b/a Lawnwood Regional Medical Center and Heart Institute, 1700 South 23rd Street, Fort Pierce, FL 34950

100246

04/20/2005

108. LDS Hospital, 8th Avenue and C Street, Salt Lake City, UT 84143

460010

04/20/2005

109. Lee's Summit Hospital, 530 NW. Murray Road, Lee's Summit, MO 64081

260190

05/17/2005

110. Lenox Hill Hospital, 100 East 77 Street, New York, NY 10021

330119

05/16/2005

111. Los Alamitos Medical Center, 3751 Katella Avenue, Los Alamitos, CA 90720

050551

05/23/2005

112. Los Robles Hospital and Medical Center, 215 West Janss Road, Thousand Oaks, CA 91360

050549

05/16/2005

113. Louisiana Heart Hospital, 64030 Louisiana Highway 434, Lacombe, LA 70445

190250

04/01/2005

114. Lourdes Vascular Center, Lourdes Hospital, 1530 Lone Oak Road, Paducah, KY 42003

180102

03/30/2005

115. Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60153

140276

05/05/2005

116. Lutheran Hospital of Indiana, 7950 West Jefferson Boulevard, Fort Wayne, IN 46804

150017

04/18/2005

117. Maricopa Integrated Health System, Maricopa Medical Center, Cardiac Catheterization Laboratory, 2601 E. Roosevelt, Phoenix, AZ 85008

032595

05/23/2005

118. Martha Jefferson Hospital, 459 Locust Avenue, Charlottesville, VA 22902

490077

04/07/2005

119. Mary Greeley Medical Center, 1111 Duff Avenue, Ames, IA 50010

160030

03/30/2005

120. Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114

220071

05/03/2005

121. Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ 85054

030103

05/23/2005

122. Medical Center of Plano, 3901 West 15th Street, Plano, TX 75075

450651

05/16/2005

123. Medical College of Ohio, 3000 Arlington Avenue, Toledo, OH 43614

360048

04/27/2005

124. Medical University of South Carolina Hospital Authority, 169 Ashley Avenue, PO Box 250347, Charleston, SC 29425

420004

05/26/2005

125. Memorial Hospital Jacksonville, 3625 University Boulevard, South, Jacksonville, FL 32216

100179

04/27/2005

126. Memorial Medical Center, 2700 Napoleon Ave, New Orleans, LA 70115

190135

05/16/2005

127. Mercy Health Center, 4300 West Memorial Road, Oklahoma City, OK 73120-8304

370013

04/12/2005

128. Mercy Hospital, 500 E. Market Street, Iowa City, IA 52245

160029

05/05/2005

129. Mercy Hospital Fairfield, 3000 Mack Road, Fairfield, OH 45014

360056

05/17/2005

130. Mercy Hospital and Medical Center, 2525 South Michigan Avenue, Chicago, IL 60616

140158

05/05/2005

131. Mercy Medical Center, 701 10th Street SE, Cedar Rapids, IA 52403

160079

04/07/2005

132. Mercy Medical Center, 1111 6th Avenue, Des Moines, IA 50314

160083

04/12/2005

133. Mercy Medical Center, 301 St. Paul Place, Baltimore, MD 21202

210008

05/25/2005

134. Methodist Hospital, 300 West Huntington Drive, P.O. Box 60016, Arcadia, CA 91066-6016

050238

04/12/2005

135. Methodist Medical Center of Oak Ridge, 990 Oak Ridge Turnpike, Oak Ridge, TN 37830

440034

05/03/2005

136. Mid Michigan Medical Center-Midland, 4005 Orchard Drive, Midland, MI 48670

230222

05/10/2005

137. Missouri Baptist Medical Center, 3015 N. Ballas Road, St. Louis, MO 63131

260108

05/23/2005

138. Morton Plant Hospital, 300 Pinellas Street, Clearwater, FL 33756

100127

05/16/2005

139. Moses H. Cone Memorial Hospital, 1200 N. Elm Street, Greensboro, NC 27401

340091

04/18/2005

140. Mount Carmel St. Ann's Hospital, 500 South Cleveland Avenue, Westerville, OH 43081-8998

360012

05/25/2005

141. Mount Diablo Medical Center, 2540 East Street, PO Box 4110, Concord, CA 94524-4110

050496

05/10/2005

142. [The] Mount Sinai Hospital, 1 Gustave L. Levy Place, New York, NY 10029

330024

05/26/2005

143. Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL 33140

100034

04/07/2005

144. Mountain View Regional Medical Center, 4311 E. Lohman Avenue, Las Cruces, NM 88011

320085

04/26/2005

145. Munroe Regional Medical Center, 1500 SW. 1st Avenue, Ocala, FL 34474

100062

05/23/2005

146. New York Presbyterian Hospital, 161 Ft. Washington Avenue, HIP1412, New York, NY 10032

330101

05/05/2005

147. Norman Regional Hospital, 901 North Porter, Box 1308, Norman, OK 73070-1308

370008

05/23/2005

148. North Austin Medical Center, 12221 MoPac Expressway North, Austin, TX 78758

450809

04/12/2005

149. North Florida Regional Medical Center, 6500 Newberry Road, Gainesville, FL 32605

100204

04/19/2005

150. North Memorial Health Care, 3300 Oakdale Avenue North, Robbinsdale, MN 55422

240001

05/26/2005

151. North Oakland Medical Centers, 461 W. Huron Street, Pontiac, MI 48341-1651

230013

05/03/2005

152. Northeast Methodist Hospital, 12412 Judson Road, Live Oak, TX 78233

450388

05/11/2005

153. Northwestern Memorial Hospital, 251 East Huron Street, Chicago, IL 60611

140281

04/26/2005

154. Norton Healthcare, P.O. Box 35070, Louisville, KY 40232-5070

180088

05/03/2005

155. Ochsner Clinic Foundation, Department of Cardiology, 1514 Jefferson Highway, New Orleans, LA 70121-2483

190036

04/12/2005

156. Ohio State University, University Medical Center, 452 West 10th Avenue, Columbus, OH 43210

360085

05/05/2005

157. Oklahoma Heart Hospital, 4050 West Memorial Road, Oklahoma City, OK 73120

370215

05/23/2005

158. Orlando Regional Healthcare System, Inc, 1414 Kuhl Avenue, Orlando, FL 32806

100006

05/23/2005

159. [The] Ortenzio Heart Center and Holy Spirit, 503 North 21st Street, Camp Hill, PA 17011-2288

390004

04/27/2005

160. OSF Saint Francis Medical Center, 530 NE. Glen Oak Avenue, Peoria, IL 61637

140067

04/27/2005

161. Our Lady of Bellefonte Hospital, St. Christopher Drive, Ashland, KY 41101

180036

05/26/2005

162. Our Lady of Lourdes Medical Center, 1600 Haddon Avenue, Camden, NJ 08103

310029

05/05/2005

163. Our Lady of Lourdes Regional Medical Center, 611 St. Landry Street, Lafayette, LA 70506

190102

05/03/2005

164. Palomar Medical Center, 555 East Valley Parkway, Escondido, CA 92025

050115

05/10/2005

165. Parkwest Medical Center, 9352 Park West Boulevard, Knoxville, TN 37923

440173

05/05/2005

166. Parkview Hospital, 2200 Randallia Drive, Fort Wayne, IN 46805

150021

05/11/2005

167. Parma Community General Hospital, 7007 Powers Boulevard, Parma, OH 44129-5495

360041

05/05/2005

168. Phoenix Baptist Hospital, Cardiac Catheterization Laboratory/Interventional Radiology Suite, 2000 West Bethany Home Road, Phoenix, AZ 85015

030030

04/01/2005

169. Phoenix Memorial Hospital, Cardiac Catheterization Laboratory/Interventional Radiology Suite, 1201 South 7th Avenue, Phoenix, AZ 85007

030106

05/16/2005

170. Pinnacle Health Hospitals, 111 South Front Street, Harrisburg, PA 17101

390067

05/23/2005

171. Plaza Medical Center of Fort Worth, 900 Eighth Avenue, Fort Worth, TX 76104

450672

05/23/2005

172. Pomerado Hospital, 15615 Pomerado Road, Poway, CA 92064

050636

05/10/2005

173. Presbyterian Hospital of Dallas, 8200 Walnut Hill Lane, Dallas, TX 75231-4496

450462

05/10/2005

174. Princeton Baptist Medical Center, 701 Princeton Avenue, SW, Birmingham, AL 35211-1399

010103

04/12/2005

175. Provena Saint Joseph Hospital, 77 North Airlite Street, Elgin, IL 60123-4912

140217

05/11/2005

176. Providence Portland Medical Center, 4805 Northeast Glisan Street, Portland, OR 97213-2967

380061

05/16/2005

177. Providence St. Vincent Medical Center, 9205 S.W. Barnes Road, Portland, OR 97225

380004

05/16/2005

178. Rapid City Regional Hospital, 353 Fairmont Boulevard, Rapid City, SD 57701

430077

05/26/2005

179. Rapides Regional Medical Center, Box 30101, 211 Fourth Street, Alexandria, LA 71301-8454

190026

05/23/2005

180. Research Medical Center, 2316 East Meyer Boulevard, Kansas City, MO 64132

260027

05/23/2005

181. Resurrection Medical Center, 7435 West Talcott, Chicago, Illinois 60631

140117

04/12/2005

182. Riverside Methodist Hospital, 3535 Olentangy River Road, Columbus, OH 43214

360006

04/20/2005

183. Robert Packer Hospital, One Guthrie Square, Sayre, PA 18840-1698

390079

04/18/2005

184. Rogue Valley Medical Center, 2825 East Barnett Road, Medford, OR 97504

380018

05/05/2005

185. Rush University Medical Center, 1725 West Harrison Street, Suite 364, Chicago, IL 60612-3824

140119

04/20/2005

186. Sacred Heart Health System, 5151 N. Ninth Avenue, P.O. Box 2700, Pensacola, FL 32513

100025

05/05/2005

187. Sacred Heart Medical Center, Oregon Heart & Vascular Institute, 1255 Hilyard Street, P.O. Box 10905, Eugene, OR 97440

380033

05/26/2005

188. Saint Joseph Health Center, 1000 Carondelet Drive, Kansas City, MO 64114

260085

05/16/2005

189. Saint Joseph Medical Center, Twelfth and Walnut Streets, P.O. Box 316, Reading, PA 19603-316

390096

04/01/2005

190. Saint Louis University Hospital, 3635 Vista at Grand Boulevard, P.O. Box 15250, St. Louis, MO 63110

260105

05/17/2005

191. Saint Luke's Hospital of Kansas City, 4401 Wornall Road, Kansas City, MO 64111

260138

04/27/2005

192. Saint Raphael Healthcare System, 1450 Chapel Street, New Haven, CT 06511

070001

05/05/2005

193. Saints Memorial Medical Center, 1 Hospital Drive, Lowell, MA 01852-1389

220082

04/27/2005

194. Samaritan Hospital, 310 South Limestone Street, Lexington, KY 40508

180007

05/17/2005

195. Seton Medical Center, 1900 Sullivan Avenue, Daly City, CA 94015

050289

05/05/2005

196. Shady Grove Adventist Hospital, 9901 Medical Center Drive, Rockville, MD 20850

210057

04/20/2005

197. Shands Jacksonville Medical Center, 655 West Eighth Street, Jacksonville, FL 32209

100001

05/26/2005

198. Shawnee Mission Medical Center, 9100 W. 74th Street, Shawnee Mission, KS 66204

170104

05/16/2005

199. Sierra Medical Center, 1625 Medical Center Drive, El Paso, TX 79902

450668

05/16/2005

200. Sinai-Grace Hospital, 6071 W. Outer Drive, Detroit, MI 48235

230024

04/19/2005

201. Sioux Valley Hospital USD Medical Center, 1305 W. 18th Street, Sioux Falls, SD 57117-5039

430027

04/19/2005

202. Skyline Medical Center, 3441 Dickerson Pike, Nashville, TN 37207

440006

04/07/2005

203. South Austin Hospital, 901 W. Ben White, Austin, TX 78704

450713

04/12/2005

204. Southern Baptist Hospital of Florida, Inc., d/b/a Baptist Medical Center, 800 Prudential Drive, Jacksonville, FL 32207

100088

05/05/2005

205. Southern Maryland Hospital Center, 7503 Surratts Road, Clinton, MD 20735

520054

05/26/2005

206. Southwest Washington Medical Center, P.O. Box 1600, Vancouver, WA 98668

500050

05/26/2005

207. Spectrum Health Hospital, 100 Michigan Street NE, Grand Rapids, MI 49503

230038

04/18/2005

208. SSM St. Joseph Health Center, 300 First Capitol Drive, St. Charles, MO 63301

260005

04/26/2005

209. St. Anthony's Hospital, 1200 7th Avenue North, St. Petersburg, FL 33705

100067

04/19/2005

210. St. Bernardine Medical Center, 2101 N. Waterman Avenue, San Bernardino, CA 92404-4836

050129

05/05/2005

211. St. David's Medical Center, 919 East 32nd Street 78705, P.O. Box 4039, Austin, TX 78765-4039

450431

05/05/2005

212. St. Elizabeth Medical Center, South Unit, 1 Medical Village Drive, Edgewood, KY 41017

180035

04/26/2005

213. St. Francis Hospital and Health Center, 12935 S. Gregory Street, Blue Island, IL 60406

140118

05/11/2005

214. St. Francis Hospital & Health Centers, 1600 Albany Street, Beech Grove, IN 46107

150033

04/01/2005

215. St. John Hospital and Medical Center, 22151 Moross Road, Detroit, MI 48236

230165

04/27/2005

216. St John's Hospital, 800 East Carpenter Street, Springfield, IL 62769

140053

05/10/2005

217. St. John's Regional Medical Center, 2727 McClelland Boulevard, Joplin, MO 64804-1694

260001

04/19/2005

218. St. John West Shore Hospital, 29000 Center Ridge Road, Westlake, OH 44145

360123

05/03/2005

219. St. Joseph Medical Center, Heart Institute, 7601 Osler Drive, Towson, MD 21204-7582

210007

05/17/2005

220. St. Joseph Mercy Hospital, 5301 E. Huron River Drive, P.O. Box 995, Ann Arbor, MI 48106

230156

05/16/2005

221. St. Joseph Regional Medical Center, 5000 West Chambers Street, Milwaukee, WI 53210-1688

520136

05/10/2005

222. St. Joseph's Medical Center, 1800 N. California Street, Stockton, CA 95204

050084

05/17/2005

223. St. Joseph's Mercy Health Center, 300 Werner Street, Hot Springs, AR 71903

040026

05/26/2005

224. St. Joseph's Wayne Hospital, 224 Hamburg Turnpike, Wayne, NJ 07470

310116

03/30/2005

225. St. Luke's, 915 East First Street, Duluth, MN 55805

240047

04/19/2005

226. St. Lukes Episcopal Hospital, 6720 Bertner Avenue, Houston, TX 77030

450193

03/30/2005

227. St. Luke's Hospital, 1026 A Avenue NE, P.O. Box 3026, Cedar Rapids, IA 52406-3026

160045

05/10/2005

228. St. Luke's Medical Center, 2900 W. Oklahoma Avenue, P.O. Box 2901, Milwaukee, WI 53201-2901

520138

04/18/2005

229. St. Luke's-Roosevelt Hospital Center, 1000 Tenth Avenue, New York, NY 10019

330046

05/23/2005

230. St. Mary's Hospital and Medical Center, 2635 North Seventh Street, P.O. Box 1628, Grand Junction, CO 81501

060023

04/20/2005

231. St Mary's Medical Center, 407 East Third Street, Duluth, MN 55805

240002

05/16/2005

232. St. Mary's Medical Center, 3700 Washington Avenue, Evansville, IN 47740-001

150100

05/17/2005

233. St. Patrick Hospital and Health Sciences Center, 500 West Broadway, Missoula, MT 59802

270014

04/12/2005

234. St. Thomas Hospital, 4220 Harding Road, Nashville, TN 37205

440082

04/19/2005

235. Strong Memorial Hospital, 601 Elmwood Avenue, Box 679, Rochester, NY 14642

330285

04/19/2005

236. Swedish American Hospital, 1401 East State Street, Rockford, IL 61104

140228

05/03/2005

237. Swedish Medical Center, 501 East Hampden Ave, Englewood, CO 80113

060034

05/16/2005

238. Swedish Medical Center-First Hill Campus, 747 Broadway, Seattle, WA 98122

500027

05/17/2005

239. Swedish Medical Center-Providence Campus, 747 Broadway, Seattle, WA 98122

500025

05/23/2005

240. Tallahassee Memorial, 1300 Miccosukee Road, Tallahassee, FL 32308

100135

05/16/2005

241. Terrebonne General Medical Center, 8166 Main Street, Houma, LA 70360

190008

04/20/2005

242. Texan Heart Hospital, 6700 IH-10 West, San Antonio, TX 78201

450878

05/26/2005

243. Town and Country Hospital, 6001 Webb Road, Tampa, FL 33615-3241

100255

05/05/2005

244. UC Davis Cardiac Cath Lab/UC Davis Medical Center, 2315 Stockton Boulevard, Sacramento, CA 95817

050599

04/19/2005

245. Union Hospital, 1606 North Seventh Street, Terre Haute, IN 47804-2780

150023

04/27/2005

246. Union Memorial Hospital, 201 East University Parkway, Baltimore, MD 21218-2895

210024

04/07/2005

247. United Regional Health Care System, Eleventh Street Campus, 1600 Eleventh Street, Wichita Falls, TX 76301

450010

05/16/2005

248. University of Alabama Hospital, 619 South 19th Street, Birmingham, AL 35233

010033

05/26/2005

249. University Health System, 1520 Cherokee Trail, Suite 200, Knoxville, TN 37920-2205

440015

05/26/2005

250. University Health System, 4502 Medical Drive, San Antonio, TX 78229

450213

04/27/2005

251. University of Kentucky Hospital, 800 Rose Street, Lexington, KY 40536-0293

180067

05/16/2005

252. University of Louisville Hospital, 530 South Jackson Street, Louisville, KY 40202

180141

05/05/2005

253. University of Pennsylvania Medical Center-Presbyterian, 39th and Market Streets, Philadelphia, PA 19104

390223

04/01/2005

254. UPMC Presbyterian Shadyside, 200 Lothrop Street, Pittsburgh, PA 15213

390164

05/03/2005

255. Utah Valley Regional Medical Center, 1034 North 500 West, Provo, Utah 84605

460001

05/26/2005

256. The Valley Hospital, 223 N. Van Dien Avenue, Ridgewood, NJ 07450-2736

310012

04/20/2005

257. Vassar Brothers Medical Center, 45 Reade Place, Poughkeepsie, NY 12601

330023

05/05/2005

258. Washoe Medical Center, 75 Pringle Way, Reno, NV 89502

290001

04/27/2005

259. Washington Hospital Center, 110 Irving Street, NW., Washington, DC 20010

090011

05/16/2005

260. Wellmont Holston Valley Medical Center, Holston Valley Vascular Institute, 130 W. Ravine Road, Kingsport, TN 37660

440017

05/16/2005

261. Wentworth-Douglass Hospital, 789 Central Avenue, Dover, NH 03820

300018

05/10/2005

262. West Allis Memorial Hospital, 8901 West Lincoln Avenue, West Allis, WI 53227

520139

05/26/2005

263. Westchester Medical Center, 95 Grasslands Road, Valhalla, NY 10595

330234

05/16/2005

264. Western Baptist Hospital, 2501 Kentucky Avenue, Paduach, KY 42003-3200

180104

05/05/2005

265. Western Medical Center-Santa Ana, 1001 North Tustin Avenue, Santa Ana, CA 92705

050746

05/25/2005

266. William Beaumont Hospital, 3601 W. 13 Mile Road, Royal Oak, MI 48073

230130

05/10/2005

267. Willis Knighton Bossier, 2400 Hospital Drive, Bossier City, LA 71111

190236

04/27/2005

268. Willis Knighton Medical Center, 2600 Greenwood Road, Shreveport, LA 71103

190111

04/27/2005

269. Winchester Medical Center, P.O. Box 3340, Winchester, VA 22604-2540

490005

05/16/2005

270. The Wisconsin Heart Hospital, LLC, 10000 West Blue Mound Road, Wauwatosa, WI 53226

520199

05/05/2005

271. Wyoming Valley Health Care System, 575 North River Street, Wilkes Barre, PA 18764

390137

04/26/2005

272. York Hospital, 15 Hospital Drive, York, ME 03909

200020

04/14/2005

[FR Doc. 05-12525 Filed 6-23-05; 8:45 am]

BILLING CODE 4120-01-P