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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9025-N]

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

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice lists CMS manual instructions, substantive and interpretive regulations, and other

Federal Register

notices that were published from October 2004 through December 2004, 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. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations.

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

Federal Register

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

FOR FURTHER INFORMATION CONTACT:

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

Questions concerning items in Addendum III may be addressed to 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 Eileen Davidson, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, S3-26-10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6874.

Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Dawn Willinghan, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6141.

Questions concerning all other information may be addressed to Margaret Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4678.

SUPPLEMENTARY INFORMATION:

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 six addenda:

• Addendum I lists the publication dates of the most recent quarterly listings of program issuances.

• Addendum II identifies previous

Federal Register

documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.

• Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.

• Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the

Federal Register

during the quarter covered by this notice. For each item, we list the—

—Date published;

—

Federal Register

citation;

—Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);

—Agency file code number; and

—Title of the regulation.

• Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.

• Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.

• Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information 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 “Treatment of Obesity,” use CMS-Pub. 100-03, Transmittal No. 23.

(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: February 14, 2005.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

Addendum I

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

September 27, 2002 (67 FR 61130); December 27, 2002 (67 FR 79109); March 28, 2003 (68 FR 15196); June 27, 2003 (68 FR 38359); September 26, 2003 (68 FR 55618); December 24, 2003 (68 FR 74590); March 26, 2004 (69 FR 15837); June 25, 2004 (69 FR 35634); September 24, 2004 (69 FR 57312); and December 30, 2004 (69 FR 78428).

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

[October Through December 2004]

Transmittal No.

Manual/Subject/Publication Number

Medicare General Information (CMS-Pub. 100-01)

11

Manual Revision Regarding Waiver of Annual Deductible and Coinsurance for Both Ambulatory Surgery Center Facility, and Ambulatory Surgery Center/Hospital Outpatient Department Physician Services Exceptions to Annual Deductible and Coinsurance.

12

New Policy and Refinements on Billing Non-covered Charges to Fiscal Intermediaries.

Applications of Deductible and Coinsurance in Liability and Indemnification Situations.

13

Medicare Termination of Beneficiaries With End-Stage Renal Disease.

14

Scheduled Release for January Updates to Software Programs and Coding/Files.

Medicare Benefit Policy (CMS-Pub. 100-02)

23

Revised Requirements for Chiropractic Billing of Active/Corrective Treatment And Maintenance Therapy Full Replacement of CR 3063

Chiropractor's Services.

Necessity of Treatment.

Treatment Parameters.

24

Revision of § 300.5.1, Chapter 15 of the Medicare Benefit Policy Manual to Include 22x Type of Bill for Diabetes Self-Management Training.

Special Claims Processing Instructions for Fiscal Intermediary.

25

Implementation of Coverage of Religious Nonmedical Health Care.

Institution Items and Services Furnished in the Home, Medicare Modernization Act Section 706.

Coverage of Religious Nonmedical Health Care Institution Items and Services Furnished in the Home.

Coverage and Payment of Durable Medical Equipment aUnder the Religious Nonmedical Health Care Institution Home Benefit.

Coverage and Payment of Home Visits Under the Religious Nonmedical Health Care Institution Home Benefit.

26

Inclusion of Forteo as a Covered Osteoporosis Drug and Clarification of Manual.

Instructions Regarding Osteoporosis Drugs.

Medical Supplies (Except for Drugs and Biologicals Other Than Covered Osteoporosis Drugs) and the Use of Durable Medical Equipment.

Covered Osteoporosis Drugs.

27

New End-Stage Renal Disease Composite Payment Rates Effective January 1, 2005.

28

Hospice Pre-Election Evaluation and Counseling Services.

Documentation.

Payment.

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

22

This Transmittal has been rescinded and replaced with Transmittal 25.

23

Treatment of Obesity.

24

Dementia and Neurodegenerative Diseases.

25

Percutaneous Transluminal Angioplasty.

26

Electrocardiographic Services.

Medicare Claims Processing (CMS-Pub. 100-04)

305

Disabling the Common Working File 57x3 Consistency Error Code.

306

Full Replacement of CR 3415, 3rd Update to the 2004 Medicare Physician Fee Database.

307

This Transmittal has been rescinded and replaced with Transmittal 314.

308

Two New Medicare Summary Notice (MSN) Messages for Parenteral Pumps-DMERC Only.

Durable Medical Equipment.

309

Fiscal Year 2005 Inpatient Prospective Payment System, Long Term Care.

Hospital and Other Bill Processing Changes Related to the Inpatient.

Prospective Payment System Final Rule.

310

Billing Requirements for Positron Emission Tomography Scans for Dementia and Neurodegenerative Diseases.

Billing Instructions.

Positron Emission Tomography Scan Qualifying Conditions and Healthcare.

Common Procedure Coding System Code Chart.

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

311

Instructions for Completion of Form CMS-1450.

Health Insurance Portability and Accountability Act Health Care and Coordination of Benefits.

Coordination of Benefits.

General Instructions for Completion of Form CMS—1450 for Billing.

312

Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction.

313

Remittance Advice Remark Code and Claim Adjustment Reason Code Update.

314

Percutaneous Transluminal Angioplasty.

315

Temporary Change in Carrier Jurisdictional Pricing Rules for Purchased Diagnostic Services.

316

Clarification of Messages in Chapter 1, Section 10.1.1.1 to Match Official Listing on the WPC-Electronic Data Interchange Web Site.

Claims Processing Instructions for Payment Jurisdiction for Claims Received on or After April 1, 2004.

317

Clarification to Chapter 26 of the Internet Only Manual.

Patient and Insured Information.

Provider of Service or Supplier Information.

318

Clarification of CR 3176—Payment Amounts for End-Stage Renal Disease Drug.

Administration Supplies: Healthcare Common Procedure Coding System A4657 and A4913.

319

Comprehensive Outpatient Rehabilitation Facility/Outpatient Physical Therapy.

Edit for Billing Inappropriate Supplies.

320

Reminder Notice of the Implementation of the Ambulance Transition.

Schedule.

321

Instructions for Downloading the Medicare Zip Code File.

322

Release Medlearn Article for Change Request CR 2813 End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Test(s).

323

Update Regarding the Use of American Dental Association's (ADA) Current Dental Terminology Codes on Medicare Contractor's Web Sites and Other Electronic Media.

Displaying Material With Content Development Team Codes.

Use of Content Development Team Nomenclature and Descriptors.

American Dental Association Copyright Notice.

Point and Click License, and Shrink Wrap License.

Samples of Content Development Team Nomenclature and Descriptors.

324

Quarterly Update to Correct Coding Initiative (CCI) edits, Version 11.0, Effective January 1, 2005.

325

New Waived Tests—January 1, 2005.

326

Invalid Diagnosis Code Editing—Second Phase.

327

This Transmittal has been rescinded and replaced with Transmittal 374.

328

2005 Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers.

329

Durable Medical Equipment Regional Carrier Only—Payment to Providers/Suppliers Qualified To Bill Medicare for Prosthetics and Certain Custom-Fabricated Orthotics.

Provider Billing for Prosthetics and Orthotic Services.

330

Durable Medical Equipment Carrier—Beneficiary Submitted Claims, Process First Claim.

General Billing for DME, Prosthetics, Orthotic Devices, and Supplies.

331

Durable Medical Equipment Carrier—Beneficiary Submitted Claims, Process First Claim.

332

New Policy and Refinements on Billing Noncovered Charges to Fiscal Intermediaries.

Provider Billing of Noncovered Charges to Fiscal Intermediaries.

General Information on Institutional Noncovered Charges Prior to Billing.

Provider-Liable Fully Noncovered Outpatient Claims.

Summary of All Types of Institutional No Payment Claims.

General Operational Information on Institutional Noncovered Charges.

Noncovered Charges on Institutional Demand Bills.

Traditional Demand Bills.

Summary of Methods for Institutional Demand Billing.

Line-Item Modifiers Related to Reporting of Noncovered Charges When Covered and Noncovered Services Are on the Same Institutional Claim.

Clarifying Institutional Instructions for Outpatient Therapies Billed As Noncovered, on Other Than Hold Harmless Prospective Payment System Claims, and for Critical Access Hospitals Billing the Same Health Common.

Procedure Coding System Requiring Specific Time Increments.

Instructions for Noncovered Charges on Institutional Ambulance Claims.

Clarification on Notice Requirements Related to Billing Noncovered Charges for “Bundled” Institutional Benefits: Laboratory and Rural Health Clinic/Federally Qualified Health Clinic.

333

Issued to a specific audience, not posted to the Internet/Intranet due to the confidentiality of instruction.

334

Payment of Beneficiary Submitted Flu Claims and Flu Claims Submitted by Non-Enrolled Providers.

335

This Transmittal has been rescinded and replaced with Transmittal 400.

336

Indian Health Service or Tribal Hospitals including Critical Access Hospital.

Payment Methodology for Inpatient Social Admissions and Outpatient Services Occurring During Concurrent Stays.

Indian Health Service/Tribal Hospital Inpatient Social Admits.

337

Change in Hospital Type of Bill for Billing Diagnostic and Screening Mammographies.

Mammography Services.

Computer-Aided Detection Add-On Codes.

Billing Requirements—Fiscal Intermediary Claims.

Rural Health Clinic/Federally Qualified Health Center Claims With Dates of Service Prior to January 1, 2002.

Rural Health Clinic/Federally Qualified Health Center Claims With Dates of Service on or After January 1, 2002.

Fiscal Intermediary Requirements for Nondigital Screening Mammographies.

Mammograms Performed With New Technologies.

338

Removal of the Skilled Nursing Facility No Pay File.

339

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

340

Annual Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement.

341

Implementation of the Medicare Physician Fee Schedule (MPFS) National Abstract File for Purchased Diagnostic Tests and Interpretations.

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.

Abstract File for Purchased Diagnostic Tests/Interpretations.

342

Change to the Common Working File Skilled Nursing Facility Consolidated.

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

Skilled Nursing Facility Billing.

343

Clarification: Modifiers for Transportation of Portable X-rays.

Transportation Component.

344

Update of Healthcare Common Procedure Coding System Codes and File Names, Descriptions and Instructions for Retrieving the 2005 Ambulatory Surgery.

Center Healthcare Common Procedure Coding System Deletions and Master Listing.

345

This Transmittal is rescinded and replaced with Transmittal 353.

346

This Transmittal is rescinded and replaced with Transmittal 352.

347

Inpatient Rehabilitation Facility Classification Requirements.

Medicare Inpatient Rehabilitation Facility Classification Requirements.

Criteria That Must Be Met By Inpatient Rehabilitation Hospitals.

Verification Process To Be Used To Determine if the Inpatient Rehabilitation.

Facility Met the Classification Criteria.

Verification of Compliance Using International Classification of Disease 9th Edition Clinical Modification and Impairment Group Codes.

348

January 2005 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective January 1, 2005.

349

This Transmittal is rescinded and replaced with Transmittal 359.

350

Editing for Part B Carriers and Durable Medical Equipment Regional Carriers for Duplicate Claims in Process at the Same Time.

351

Editing of Hospitals and Skilled Nursing Facilities Part B Inpatient Services.

352

Three Places After the Decimal Point for Application Service Provider Drug File.

353

Durable Medical Equipment Regional Carrier—Revision to CR 2631.

Requirements for Durable Medical Equipment Regional Carrier Claims.

Claims Processing Instructions for Payment Jurisdiction for Claims Received on or After April 1, 2004—Durable Medical Equipment Regional Carrier Only.

354

DMERC—Beneficiary Submitted Claims, Process First Claim.

355

This Transmittal has been rescinded and replaced with Transmittal 375.

356

This Transmittal has been rescinded and replaced with Transmittal 376.

357

Implementation of Coverage of Religious Nonmedical Health Care Institution.

Items and Services Furnished in the Home, MMA section 706.

Noncovered Charges on Outpatient Bills.

Billing and Payment of Religious Nonmedical Health Care Institution Items and Services Furnished in the Home.

Inclusion of Forteo As a Covered Osteoporosis Drug and Clarification of Manual Instructions Regarding Osteoporosis Drugs.

Osteoporosis Injections as Home Health Agency Benefit.

358

This Transmittal replaces Transmittal 349.

359

Annual Update of Healthcare Common Procedure Coding System Codes for Skilled Nursing Facility Consolidated Billing.

360

Medicare Modernization Act Drug Pricing Update—Payment Limit for J0207.(Amifostine).

361

Update to the Prospective Payment System for Home Health Agencies for Calendar Year 2005.

Annual Updates to the Home Health Pricer.

362

2005 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment.

363

Common Working File Editing for the Initial Preventive Physical Examination.

364

Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction.

365

Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction.

366

This Transmittal has been rescinded and replaced with Transmittal 425.

367

Instructions for Completion of Form CMS-1450.

368

Fee Schedule Update for 2005 for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.

369

New Case-Mix Adjusted End-Stage Renal Disease (ESRD) Composite.

Payment Rates and New Composite Rate Exceptions Window for Pediatric.

ESRD Facilities.

Outpatient Provider Specific File.

Calculation of Case Mix Adjusted Composite Rate.

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

370

Updated Billing Instructions for Rural Health Clinics and Federally Qualified.

Health Centers.

General Billing Requirements.

Special Federally Qualified Health Centers Requirements.

Reporting of Preventive Services in the Federally Qualified Health Centers.

Benefit by Independent Federally Qualified Health Centers.

Reporting of Specific Healthcare Common Procedure Coding System Codes for Hospital-based Federally Qualified Health Centers.

General Billing Requirements for Preventive Services.

Bills Submitted to Fiscal Intermediary.

Special Instructions for Independent and Provider-Based Rural Health Clinics/Federally Qualified Health Centers.

Claims Submitted to Intermediaries for Mass Immunizations of Influenza and

Pneumococcal Pneumonia Vaccine

Payment for Computer Add-on Diagnostic and Screening Mammograms for Fiscal Intermediary and Carriers.

Rural Health Centers/Federally Qualified Health Centers Claims With Dates of Service Prior to January 1, 2002.

Rural Health Centers/Federally Qualified Health Centers Claims With Dates of Service on or After January 1, 2002.

Healthcare Common Procedure Coding Codes for Billing.

Additional Coding Applicable to Claims Submitted to Fiscal Intermediary.

Special Billing Instructions for Rural Health Centers and Federally Qualified.

Health Centers.

Electrical Stimulation.

Electromagnetic Therapy.

371

Payment for Referred Laboratory Automated Multi-Channel Chemistry Tests.

Claims Processing Requirements for Panel and Profile Tests.

History Display.

372

New End-Stage Renal Disease Composite Payment Rates Effective Lanuary 1, 2005.

Publication of Composite Rates.

Determining Individual Facility Composite Rate.

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

Epoetin Alfa.

Epoetin Alfa Facility Billing Requirement Using UB-92/Form CMS-1450.

Payment Amount for Epoetin Alfa.

Epoetin Alfa Provided in the Hospital Outpatient Departments.

Darbepoetin Alfa for End-Stage Renal Disease Patients.

373

Clarification to IOM Chapter 17, Section 80.4 Regarding Claims for Blood Clotting Factors.

Billing for Blood Clotting Factors.

374

This Transmittal has been rescinded and replaced with 388.

375

This Transmittal has been rescinded and replaced with 389.

376

Hospital Outpatient Prospective Payment System: Misclassified Drugs and Biologicals, Ganciclovir Long Act Implant, Beg Live Intravesical Vac, and Gallium ga 67; Adjustments Due to Misclassification.

377

Full Replacement of CR 3308, Fiscal Intermediary Shared System Changes To Allow for Provider Liability Days on Skilled Nursing Facility and Swing Bed Facility Inpatient Bills.

Billing Skilled Nursing Facility Prospective Payment System Services.

Provider Liability Instructions.

378

Low Osmolar Contrast Material/Laboratory Tests/Payment for Inpatient Servces.

Furnished by a Critical Access Hospital.

Payment for Inpatient Services Furnished by a Critical Access Hospital.

Standard Method—Cost Based Facility Services, With Billing of Carrier for Professional Services.

Clinical Diagnostic Laboratory Tests Furnished by Critical Access Hospitals.

379

Changes to the Laboratory National Coverage Determination Edit Software for January 2005.

380

Revisions and Corrections to Chapter 29 of the IOM, Claims Processing Manual—Appeals.

CMS Decisions Subject to the Administrative Appeals Process.

Who May Appeal.

Provider or Supplier Appeals When the Beneficiary Is Deceased.

Where To Appeal and Initial Determinations.

Social Security Office.

Part A Fiscal Intermediary.

Providers Right To Appeal Certain Initial Determinations.

Part B Carrier (or Fiscal Intermediary Acting As a Carrier).

Quality Improvement Organization.

Time Limits for Filing Appeals.

Amount in Controversy Requirements.

Limitation on Liability.

Part A Appeals Procedures.

Finding Good Cause for Late Filing of Part A Redetermination.

General.

Establishment of Time Limits for Filing.

Conditions Which Establish Good Cause.

Procedures To Establish Good Cause.

Examples of Situations Where Good Cause Exists.

Where Good Cause Is Not Found.

Redetermination of a Part A Payment Determination.

Place and Manner of Filing Requests for Redeterminations and What Constitutes a Request for Redetermination.

Evaluating the Evidence and Making the Redetermination.

Preparing the Determination.

Completing the Determination.

Notice of Further Appeal Rights.

Preventing Duplicate Payment in Reversal Cases.

Effectuating Favorable Final Appellate Decisions That a Beneficiary Is “Confined To Home”—Regional Home Health Intermediaries Only.

Model Medicare Redetermination Notice.

Request for Hearing Under Part A.

Right to Representation Under Part A.

Reconsiderations, Hearings, and Appeals Where a Quality Improvement.

Organization Has Review Responsibility.

Reconsiderations.

Hearings.

Appeals of Institutional Supplementary Medical Insurance (Part B) Claim Decisions.

Appeals by Hospitals of Diagnosis Related Group Assignments Under Prospective Payment System—Review of Initial Diagnosis Related Group Assignments.

Part B Appeals Procedures for Fiscal Intermediaries and Administrative Law Judge Instructions for Fiscal Intermediaries Redetermination and Hearing Officer (HO) Hearing Supplemental Medical Insurance.

Redetermination.

What Constitutes a Request for Redetermination & Handling Beneficiary Inquiries.

Elements of a Redetermination.

Requests for Hearing.

Preparation for the Hearing.

In-Person and Telephone Hearing Procedures.

Request for Hearing Before an Administrative Law Judge.

Scope and Effect of Office of Hearings & Appeals, Social Security.

Administration Administrative Law Judge Decisions Under Part A.

Determining the Amount in Controversy for Administrative Law Judge Hearing.

Requests Filed With Social Security Administration.

Requests Filed With the Fiscal Intermediary.

Action on Incoming Requests for Administrative Law Judge Hearing.

Requests for Claim File (Sent by Hearing Office).

Examination of Claim File.

Prehearing Case Redetermination.

Routing the Administrative Law Judge Hearing Claim File.

Effectuating Decisions.

Effectuating Favorable Final Appellate Decisions That a Beneficiary Is “Confined To Home”—Regional Home Health Intermediaries Only.Effectuation of Reversal of Decision Where There Was Subsequent Utilization of Benefits in the Same Benefit Period.

Effect of Court Decisions.

Standard Exhibits Referred to in Sections 40.5-50.7.

Part B Appeals Procedures—Carriers.

Initial Determinations.

Steps in the Appeals Process: Overview.

Fiscal Intermediary and Carrier Correspondence With Beneficiaries or Other Parties Regarding Appeals.

Appointment of Representative—Introduction.

Who May Be a Representative.

How To Make and Revoke an Appointment.

Rights and Responsibilities of a Representative.

Timeliness of an Appeal Request and Completeness of Appointment.

Incapacitation of Death of Beneficiary.

Disclosure of Individually Identifiable Beneficiary Information to Amount in Controversy—General Requirements.

Additional Considerations for Calculation of the Amount in Controversy.

Aggregation of Claims to Meet the Amount in Controversy.

General Procedure To Establish Good Cause.

Good Cause Not Found for Beneficiary, or for Provider, Physician, or Other Supplier.

General Guidelines.

Letter Format.

How To Establish Reading Level.

Required Elements in Appeals Correspondence.

Disclosure of Information to Third Parties.

Fraud and Abuse Investigations.

Medical Consultants Used.

Multiple Beneficiaries.

Redetermination—The First Level of Appeal.

Filing a Request for Redetermination.

Time Limit for Filing a Request for Redetermination.

The Redetermination.

The Redetermination Determination.

Redetermination Determination.

Informing the Beneficiary and Provider Communities About the Telephone.

Redetermination Process.

Redetermination Determination Letters.

Hearing Officer Hearing—The Second Level of Appeal.

Time Limit for Filing a Request for a Hearing Officer Hearing.

Request for a Hearing Officer Hearing Filed Prior to a Redetermination.

Timely Processing Requirements.

Contractor Responsibilities—General.

Requests for Transfer of In-Person Hearing.

Acknowledgment of Request for a Hearing Officer Hearing.

Case File Development.

In-Person Hearing.

Telephone Hearing.

Qualifications and General Responsibilities.

Preparation for the Hearing Officer Hearing.

Scheduling the Date, Time and Place of Hearing.

Pre-Hearing Review of the Evidence.

Forwarding Copy of Case File Prior to Telephone Hearing.

The Hearing Officer Hearing Decision Timeliness.

Delaying Effectuation.

Hearing Officer Reply to Reopening Request.

Requests for Part B Administrative Law Judge Hearing.

Forwarding Request to Social Security Administration/Office of Hearings & Appeals.

Case File Preparation.

Effectuation Time Limits.

Requests for Case Files.

Part A and Part B Quality Improvement and Data Analysis Activities.

Workload Data Analysis Program.

Quality Improvement Activities.

Submitting Summary Reports to CMS.

Managing Appeals Workloads.

Standard Operating Procedures.

Execution of Workload Prioritization.

Workload Priorities.

Reopening and Revision of Claim Determinations and Decisions.

Development of Appeals.

How Issues May Arise.

Summary of Conditional Under Which a Determination or Decision May Be Reopened.

Determining Date of Initial or Appeal Determination or Decision.

Who May Reopen an Initial Appeal Determination or Decision.

Actions to Permit Reopening Within the 1 Year or 4 Year Period.

Good Cause for Reopening.

Definitions.

Unrestricted Reopening.

Reopening an Initial Determination.

Reopening a Redetermination or Redetermination Determination.

Reopening a Hearing Officer Hearing Decision.

Notice of Results of Reopening.

Exception to Sending Notice of Revision to Parties—Cases Involving Limitation of Recovery for Beneficiary.

Refusal to Reopen Is Not an “Initial Determination”.

Revised Determination or Decision.

382

Independent Laboratory Billing for the Technical Component (TC) of Physician Pathology Services to Hospital Patients.

Payment for Pathology Services.

383

This revision rescinded Transmittal.

384

Inpatient Psychiatric Facility Prospective Payment System.

385

January 2005 Update of the Hospital Outpatient Prospective Payment System.

Summary of Outpatient Prospective Payment System Outpatient Code Editor.

Data Changes and Outpatient Prospective Payment System Pricer Logic.

Changes; Changes to Payment for Diagnostic Mammography.

386

Hospice Pre-election Evaluation and Counseling Services.

387

This instruction is to inform the fiscal intermediaries that the January 2005.

Outpatient Prospective Payment System Outpatient Code Editor Specifications have been updated with new additions, changes, and deletions.

388

Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction.

389

Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction.

390

Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increase—Skilled Nursing Facility Consolidated.Billing As It Applies to Rural Health Clinics and Federally Qualified Health.Center Services.

391

Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction.

392

The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2003 for Inpatient Rehabilitation Facility Prospective Payment System.

LIP Adjustment: The Supplemental Security Income Medicare Beneficiary Data for Inpatient Rehabilitation Facility Paid Under Prospective Payment System.

393

ZThis revision is rescinded and replaced with revision 401.

394

This revision is rescinded and replaced with revision 396.

395

Ambulance Fee Schedule—Medical Conditions List.

396

New Dispensing/Supply Fee Codes for Oral Anti-Cancer, Oral Anti-Emetic, Immunosuppressive, and Inhalation Drugs.

Pharmacy Supply Fee.

397

Durable Medical Equipment Regional Carrier /Local Carriers/Statistical.

Analysis Durable Medical Equipment Regional Carrier—Drug Pricing.

Limits as of January 1, 2005.

Payment Rules for Drugs and Biologicals.

Medicare Modernization Act Drug Pricing—Average Sales Price.

Single Drug Pricer.

Calculation of the Payment Allowance Limit for Durable Medical Equipment.

Regional Carriers Drugs.

Calculation of the Average Wholesale Price.

Detailed Procedures for Determining Average Wholesale Prices and the Drug.Payment Allowable Limits.

Background.

Review of Sources for Medicare Covered Drugs and Biologicals.

Use of Generics.

Find the Strength and Dosage.

Restrictions.

Inherent Reasonableness for Drugs and Biologicals.

Injection Services.

Injections Furnished to End-Stage Renal Disease Beneficiaries.

398

Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction.

399

Expansion of the Existing Interrupted Stay Policy Under Long Term Care.

Hospital Prospective Payment System.

400

Incorrect Reporting of Miles Time Units Services Indicator When Drugs are Billed Using a National Drug Code.

Miles/Times/Units/Services.

Methodology of Coding Number of Services, Miles Times Units Services.

Count and Miles Times Units Services Indicator Fields.

401

2005 Part B Deductible Update to the Back Page of Medicare Summary Notices.

Back of the Medicare Summary Notices—Carriers and Intermediaries.

402

January Update to the Medicare Outpatient Code Editor Version 20.1 for Bills from Hospitals That Are Not Paid Under the Outpatient Prospective Payment System.

403

January 2005 Update of the Hospital Outpatient Prospective Payment System: Billing Devices That Do Not Have Transitional Pass-Through Status, and That Are Not Classified As New Technology Ambulatory Payment Classification Groups.

Requirements That Hospitals Report Device Codes on Claims on Which They Report Specified Procedures.

Edits for Claims On Which Specified Procedures Are To Be Reported With Device.

Codes.

404

January 2005 Update of the Hospital Outpatient Prospective Payment System: Changes to Coding and Payment for Drug Administration.

Billing and Payment for Drugs and Biologicals.

Coding and Payment for Drug Administration.

405

Emergency Change to Carrier Instructions for the End-Stage Renal Disease.

50/50 Rule Implementation.

406

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

407

Hospital Billing for Repetitive Services.

Inpatient Billing From Hospitals and Skilled Nursing Facilities.

Frequency of Billing for Outpatient Services to Fiscal Intermediaries.

Hospital and Community Mental Health Center Reporting Requirements for Services Performed on the Same Day.

408

Cardiovascular Disease Screening.

Healthcare Common Procedure Coding System Coding for Cardiovascular Screening.

Carrier Billing Requirements.

Fiscal Intermediary Billing Requirements.

Diagnosis Code Reporting.

Medicare Summary Notices.

Remittance Advice Remark Codes.

Claims Adjustment Reason Codes.

409

Diabetes Screening Tests.

410

Medicare Health Insurance Portability & Accountability Act Electronic Claims.

Compliance Report—Reporting Timeframe Extension.

411

Ambulance Inflation Factor.

412

Skilled Nursing Facility Consolidated Billing Services Furnished Under an “Arrangement” With an Outside Entity.

“Under Arrangements” Relationships.

Skilled Nursing Facility and Supplier Responsibilities.

413

Medicare Part A Skilled Nursing Facility Prospective Payment System Pricer.

Update Fiscal Year 2005 for 9 Metropolitan Statistical Areas With New Wage.Index Values Effective January 1, 2005.

Skilled Nursing Facility Prospective Payment System Pricer Software.

414

Emergency Update to the 2005 Medicare Physician Fee Schedule Database.

415

Temporary Change in Carrier Jurisdictional Pricing Rules for Purchased Diagnostic Services.

416

Interest Payment on Clean Claims Not Paid Timely.

417

This revision rescinded and replaced revision 294.

418

Issued to a specific audience, not posted to Internet/Intranet due to the confidentiality of instruction.

419

This Transmittal has been rescinded and replaced with Transmittal 423.

420

Good Cause Waiver of Late Claim Filing Payment Reduction Penalty and Monitoring of Late Claims Submissions.

Extend Time for Good Cause.

Conditions Which Establish Good Cause.

Procedure To Establish Good Cause.

Good Cause Is Not Found.

Preparing Common Working File (CWF) Claim Records for Services Subject to 10 Percent Payment Reduction.

Monitoring Late Claims Submission Violations.

Sample Notification Letter.

Violations That Are Not Developed for Referral.

421

Correction to January 2005 Annual Update of Healthcare Common Procedure Coding.

System Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement.

422

Update to Fiscal Year 2005 Wage Index for Inpatient Prospective Payment and Outpatient Prospective Payment System Hospitals .

Medicare Secondary Payer (CMS-Pub. 100-05)

20

Secondary Payer (Medicare Secondary Payer) Savings Report Redesign.

Monthly Intermediary Report (Form CMS-1563) and Monthly Carrier Report.

(Form CMS-1564) on Medicare Secondary Payer Savings.

Savings Calculations.

Source of Savings.

Type of Savings.

Pre-payment Savings—Cost Avoid (Unpaid Medicare Secondary Payer Claims).

Pre-payment Savings—Full Recoveries.

Pre-payment Savings—Partial Recoveries.

Post-payment Savings—Full Recoveries.

Post-payment Savings—Partial Recoveries.

Total Post-payment Savings.

Electronic Submission.

Data Entry of the Forms CMS-1563 and CMS-1564.

System Calculations for Forms CMS-1563 and CMS-1564.

21

Instructions on Processing Certain Types of Medicare Secondary Payer.Claims and to Balance the Outbound Remittance Advice.

Instructions to Physicians and Suppliers on How To Submit Claims to a Medicare Carrier When There Are One or More Primary Payers.

22

Medicare Secondary Payer Debt Referral Instructions and Debt Collection Improvement Act of 1996 Activities.

Courtesy Copy of All Medicare Secondary Payer Group Health Plan-Based.

Recovery Demand Packages to the Employer's Insurer/Third Party Administrator.

Insurer/Third Party Administrator Courtesy Copy Letter.

Medicare Secondary Payer Debt Referral, “Write-Off—Closed” Instructions and Debt Collection Improvement Act of 1996 Activities.

Background.

Debt Selection, Verification of Debt, and Updating of Interest.

“Intent to Refer” Letter and Inquiries/Replies Related to Debt Improvement Act of 1996 Activities

Debt Collection System, Debt Collection System Input, Debt Transmission, Documentation to Treasury.

Actions Subsequent to Debt Collection System Input.

Medicare Secondary Payer Debt Collection Improvement Act of 1996 Tracking Report for Referral/Collection.

Monitoring Debts Excluded From the Debt Collection Improvement Act of 1996.

Referral Process.

Financial Reporting.

Compromise Requests and Extended Repayment Agreement Requests, and Waiver of Interest Requests.

Miscellaneous Questions and Answers.

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.

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

3

Medicare Systems Acceptance of New Provider Numbers for Federally Qualified Health Centers.

4

Guidance to Surveyors for Long Term Care Facilities.

5

Revisions to Appendix P (Survey Protocols for Long Term Care Facilities) and Appendix PP (Guidance to Surveyors for Long Term Care Facilities).

Medicare Program Integrity (CMS-Pub. 100-08)

84

This revision is rescinded and replaced by revision 86.

85

This revision is rescinded and replaced by revision 87.

86

Payment for Emergency Medical Treatment and Labor Act—Mandated Screening and Stabilization Services.

87

Informing Beneficiaries About Which Local Medical Review Policy and/or Local Coverage Determination and/or National Coverage Determination Is Associated With Their Claim Denial.

88

Timeframes for Processing 855 Enrollment Applications.

Provider Enrollment, Chain and Ownership System.

89

Updating Financial Reporting Requirements for Medical Review and Local Provider Education and Training.

Medical Review and Local Provider, Education, and Training.

Medical Review Overview.

Reporting Medical Review Workload and Cost Information and Documentation in Contractor Administrative, Budget & Financial Management II.

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

Automated Review Workload and Cost (Activity Code 21001).

Routine Review Workload and Cost (Activity Code 21002).

Data Analysis Cost (Activity Code 21007).

Third Party Liability or Demand Bills Workload and Cost (Activity Code 21010).

Policy Reconsideration/Revision Activities (Activity Code 21206).

Medical Review Program Management Costs (Activity Code 21207).

New Policy Development Activities (Activity Code 21208).

Complex Probe Review Workload and Cost (Activity Code 21220).

Prepay Complex Review Workload and Cost (Activity Code 21221).

Post-pay Complex Review Workload and Cost (Activity Code 21222).

Medicare Integrity Program Comprehensive Error Rate Testing Support.

Medicare Integrity Program Comprehensive Error Rate Testing Support.(Activity Code 21901).

Reporting Internal Staff Training.

Reporting Medical Review Savings in Contractor Reporting of Operational & Workload Data.

Local Provider Education and Training Overview.

Reporting Local Provider Education and Training Workload and Cost Information and Documentation in Contactor Administrative, Budget & Financial Management II.

One-on-One Provider Education a Workload and Cost (Activity Code 24116).

Education Delivered to Group of Providers Workload and Cost (Activity Code 24117).

Education Delivered via Electronic or Paper Media Workload and Cost (Activity Code 24118).

90

Prepayment Review of Claims for Medical Review Purposes.

91

Revision of Program Integrity Manual, Section 3.11.1.4.

Requesting Additional Documentation.

92

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

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

00

None.

Medicare Managed Care (CMS-Pub. 100-16)

63

Home Health Services Appeals.

64

Surveys, Contracting Strategy, Grievances and Appeals.

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

05

Consortium Contractor Management Officer and CMS Project Officer.

The (Principal) Systems Security Officer.

Personnel Security/Suitability.

IT Systems Security Program Management.

System Security Plan.

Risk Assessment.

Information Technology Systems Contingency Plan.

Annual Compliance Audit.

Corrective Action Management Process and Plans of Action and Milestones.

Computer Security Incident Response.

Systems Security Profile.

Fraud Control.

Patch Management.

Security Management Resources.

Security Configuration Management.

National Institute of Standards and Technology.

Information Security Levels.

Level 4: High Criticality and National Security Interest.

Security Room.

Intrusion Detection System.

Internet Security.

Demonstrations (CMS-Pub. 100-19)

07

Expansion of Coverage for Chiropractic Services Demonstration.

08

This revision is rescinded and replaced with Transmittal 9.

09

This revision is rescinded and replaced with Transmittal 10.

10

Issued to a specific audience, not posted to Internet/Intranet due to sensitivity of instruction.

11

Medicare Coordinated Care Demonstration—Override of Certain Medicare Secondary Payer Edit Codes.

12

Chemotherapy Demonstration Project.

13

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

One Time Notification (CMS-Pub. 100-20)

118

Shared Systems Maintainer Hours for Resolution of Problem Detected As a Result of Implementation of Change Request 2525 and Change Request 2527.

119

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

120

Override of Common Working File Edit for Observation Services Exceeding 48 Hours.

121

Modification to Fiscal Intermediary Standard System Regarding Common Working File Initiated Adjustments.

122

Shared System and Common Working File Renovation of Override Code Process and Recognition of Four 2-byte Modifier Fields on the Part B Query Record—For Multi-Carrier System Phased Implementation Approach Only.

123

Instructions for Pricing Treprostinil (Q4077).

124

Common Working File Duplicate Claim Edit for Referred Clinical Diagnostic and Purchased Diagnostic Services.

125

This revision is rescinded and replaced with revision 127.

126

Transmittal replaced by Transmittal 27 in Pub. 100-02, Medicare Benefit Policy.

127

Instructions Applicable to the Audit of Hospitals That Are Part of an Affiliated Group in Relation to the “Redistribution of Unused Resident Positions,” Section 422 of the Medicare Modernization Act of 2003, P.L. 108-173, for Purposes of Graduate Medical Education Payments.

128

Promoting Medicare's Preventive Benefits and Services on an Annual Basis.

129

2005 Drug Administration Coding Revisions.

130

Development of a Coordination of Benefits Agreement Auxiliary File and Modification of the Health Insurance Portability and Accountability Act 837 Coordination of Benefits Flat File and National Council for Prescription Drug Program File.

131

Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemption Category A Devices.

132

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

133

Shared System Maintainer Hours for Resolution of Problems Detected as a Result of Implementation of Change Request 2525 and Change Request 2527

Addendum IV.—Regulation Documents Published in the Federal Register

[October Through December 2004]

Publication date

FR vol. 69 page number

CFR parts affected

File code

Title of regulation

October 6, 2004

59929

CMS-5015-N

Medicare Program; Care Management for High-Cost Beneficiaries (CMHCB) Demonstration.

October 7, 2004

60242

403, 412, 413, 418, 460, 480, 482, 483, 485, 489

CMS-1428-CN2

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Corrections.

October 7, 2004

60158

CMS-1249-CN

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections.

October 7, 2004

60157

CMS-1360-CN

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Fiscal Year 2005; Correction.

October 22, 2004

62124

484

CMS-1265-F

Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005.

October 22, 2004

62057

CMS-1302-N

Medicare Program; Town Hall Meeting on the Medicare Provider Feedback Group (MPFG) November 16, 2004.

October 22, 2004

62056

CMS-1484-N

Medicare Program; November 22, 2004, Meeting of the Practicing Physicians Advisory Council.

October 22, 2004

62055

CMS-4078-N

Medicare Program; Meeting of the Advisory Panel on Medicare Education—November 30, 2004.

November 15, 2004

66922

412 and 413

CMS-1213-F

Medicare Program; Prospective Payment System for Inpatient Psychiatric Facilities.

November 15, 2004

66918

CMS-1267-N

Medicare Program; Coverage and Payment of Ambulance Services; Recalibration of Conversion Factor; Inflation Update for CY 2005.

November 15, 2004

66236

403, 405, 410, 411, 414, 418, 424, 484, and 486

CMS-1429-FC

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005.

November 15, 2004

65682

419

CMS-1427-FC

Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates.

November 26, 2004

69252

405 and 489

CMS-4004-FC

Medicare Program; Expedited Determination Procedures for Provider Service Terminations.

November 26, 2004

69178

416

CMS-1478-P

Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures.

November 26, 2004

68944

CMS-3149-N

Medicare Program; Meeting of Medicare Coverage Advisory Committee—January 25, 2005.

November 26, 2004

68935

CMS-1374-GNC

Medicare Program; Criteria and Standards For Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2005.

November 26, 2004

68931

CMS-2202-FN

Medicare and Medicaid Programs; Approval of Application for Deeming Authority for Ambulatory Surgical Centers by the American Association for Accreditation of Ambulatory Surgery Facilities, Inc.

November 26, 2004

68931

CMS-5011-WN

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

November 26, 2004

68815

447

CMS-2175-F

Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program.

November 30, 2004

69686

484

CMS-1265-CN2

Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005; Correction.

November 30, 2004

69536

403, 412, 413, 418, 460, 480, 482, 483, 485, and 489

CMS-1428-N

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Extension for the Hospital Applications To Receive Increases in Full Time Equivalent Resident Caps for Graduate Medical Education Payment.

December 23, 2004

76947

CMS-5036-N

Medicare Program; Solicitation for Proposals for the Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities.

December 30, 2004

78720

26 CFR Parts 54 and 602, 29 CFR Part 2590, 45 CFR Parts 144 and 146

CMS-2151-F

HIPAA Program; Final Regulations for Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers Under HIPPA Titles I and IV.

December 30, 2004

78800

26 CFR Part 54, 29 CFR Part 2590, 45 CFR Part 146

CMS-2158-P

HIPAA Program; Notice of Proposed Rulemaking for Health Coverage Portability: Tolling Certain Time Periods and Interaction With the Family and Medical Leave Act Under HIPAA Titles I and IV.

December 30, 2004

78825

26 CFR Part 54, 29 CFR Part 2590, 45 CFR Part 146

CMS-2150-NC

HIPAA Program; Request for Information on Benefit-Specific Waiting Periods Under HIPAA Titles I and IV.

December 30, 2004

78526

403, 412, 413, 418, 460, 480, 482, 483, 485, and 489

CMS-1428-F2

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal 2005 Rates; Correcting Amendment.

December 30, 2004

78466

CMS-1292-N

Medicare Program; Town Hall Meeting on the Fiscal Year 2006 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment Systems Scheduled for February 23, 2005.

December 30, 2004

78464

CMS-1285-N

Medicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (Panel)—February 23, 24, and 25, 2005 and Re-chartering of APC Panel on November 8, 2004.

December 30, 2004

78445

CMS-1249-CN2

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections.

December 30, 2004

78444

CMS-4077-FN

Medicare Program; Approval of the National Committee for Quality Assurance Deeming Authority for Medicare Advantage Local Preferred Provider Organizations.

December 30, 2004

78442

CMS-9026-N

Medicare Program; Timeline for Publication of Medicare Final Regulations After Proposed or Interim Final Regulations.

December 30, 2004

78428

CMS-9042-N

Medicare and Medicaid Program; Quarterly Listing of Program Issuances—July 2004 Through September 2004.

December 30, 2004

78426

CMS-2490-N

CLIA Program; Continued Approval of the American Association of Blood Banks for Deeming Authority.

December 30, 2004

78336

422

CMS-4041-IFC

Medicare Program; Modifications to Managed Care Rules.

December 30, 2004

78315

419

CMS-1427-CN

Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates; Wage Index Tables and Corrections.

Addendum V—National Coverage Determinations

[October Through December 2004]

A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at

http://cms.hhs.gov/coverage.

National Coverage Determinations

[October Through December 2004]

Title

NCDM

section

TN#

Issue date

Effective

date

Treatment of Obesity

40.5

R23NCD

10/01/04

10/01/04

Changes to the Laboratory NCD Edit Software for January 2005

N/A

R38CP

11/26/04

01/03/05

Dementia and Neurodegenerative Diseases

220.6.13

R24NCD

10/01/04

09/15/04

Percutaneous Transluminal Angioplasty

20.7

R25NCD

10/15/04

10/12/04

Electrocardiographic Services

20.15

R26NCD

12/10/04

08/26/04

Addendum VI—FDA-Approved Category B IDEs

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to 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 4th quarter, October Through December 2004.

G010041

G020001

G020105

G040026

G040081

G040086

G040090

G040115

G040117

G040133

G040135

G040136

G040157

G040163

G040164

G040165

G040169

G040170

G040171

G040173

G040174

G040175

G040177

G040178

G040179

G040180

G040181

G040182

G040183

G040185

G040187

G040188

G040189

G040193

G040197

G040199

G040201

G040202

G040207

G040210

G040211

G040212

G040213

G040215

G040216

G911803

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 No.

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, 431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42,

0938-0062

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, 493.1461

0938-0151

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, 482.12, 482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56

0938-0328

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 Parts 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

410.338, 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, 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

0938-0612

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 Part 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, 422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-

0938-0763

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, 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,

0938-0790

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, 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,

0938-0841

457.1005, 457.1015, 457.1180

0938-0842

412.23, 412.604, 412.606, 412.608, 412.610, 412.61a4, 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, 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

0938-0920

438.416, 438.710, 438.722, 438.724, 438.810

0938-0921

414.804

[FR Doc. 05-3551 Filed 2-24-05; 8:45 am]

BILLING CODE 4120-01-P