[Federal Register Volume 59, Number 52 (Thursday, March 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6153]


[[Page Unknown]]

[Federal Register: March 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[OIS-024-N]

 

Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances and Coverage Decisions--Fourth Quarter 1993

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations and other Federal Register notices, and 
statements of policy that were published during October, November, and 
December of 1993 that relate to the Medicare and Medicaid programs. 
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, we are including all Medicaid issuances 
and Medicare and Medicaid substantive and interpretive regulations 
(proposed and final) published during this timeframe.
    We are also providing the content of revisions to the Medicare 
Coverage Issues Manual published between October 1 and December 31, 
1993. On August 21, 1989 (54 FR 34555), we published the content of the 
Manual and indicated that we will publish quarterly any updates. Adding 
to this listing the complete text of the changes to the Medicare 
Coverage Issues Manual allows us to fulfill this requirement in a 
manner that facilitates identification of coverage and other changes in 
our manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 966-5260 (For Medicare instruction information)
Walter Rutemueller, (410) 966-5395 (For Medicare coverage information)
Pat Prete, (410) 965-3246 (For Medicaid instruction information)
Jacqueline Kidd, (410) 966-4682 (For all other information)

SUPPLEMENTARY INFORMATION:

I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs, which pay for health 
care and related services for 36 million Medicare beneficiaries and 33 
million Medicaid recipients. Administration of these programs involves 
(1) Providing information to Medicare beneficiaries and Medicaid 
recipients, health care providers, and the public; and (2) effective 
communications with regional offices, State governments, State Medicaid 
Agencies, State Survey Agencies, various providers of health care, 
fiscal intermediaries and carriers who process claims and pay bills, 
and others. To implement the various statutes on which the programs are 
based, we issue regulations under authority granted the Secretary under 
sections 1102, 1871, and 1902 and related provisions of the Social 
Security Act (the Act) and also issue various manuals, memoranda, and 
statements necessary to administer the programs efficiently.
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, statements of policy, and guidelines 
of general applicability not issued as regulations. 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, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the 3-month timeframe. Since the 
publication of our quarterly listing on June 12, 1992 (57 FR 24797), we 
decided to add Medicaid issuances to our quarterly listings. 
Accordingly, we are listing in this notice Medicaid issuances and 
Medicaid substantive and interpretive regulations published from 
October 1 through December 30, 1993.

II. Medicare Coverage Issues

    We receive numerous inquiries from the general public about whether 
specific items or services are covered under Medicare. Providers, 
carriers, and intermediaries have copies of the Medicare Coverage 
Issues Manual, which identifies those medical items, services, 
technologies, or treatment procedures that can be paid for under 
Medicare. On August 21, 1989, we published a notice in the Federal 
Register (54 FR 34555) that contained all the Medicare coverage 
decisions issued in that manual.
    In that notice, we indicated that revisions to the Coverage Issues 
Manual will be published at least quarterly in the Federal Register. We 
also sometimes issue proposed or final national coverage decision 
changes in separate Federal Register notices. Readers should find this 
an easy way to identify both issuance changes to all our manuals and 
the text of changes to the Coverage Issues Manual.
    Revisions to the Coverage Issues Manual are not published on a 
regular basis but on an as-needed basis. We publish revisions as a 
result of technological changes, medical practice changes, responses to 
inquiries we receive seeking clarifications, or the resolution of 
coverage issues under Medicare. If no Coverage Issues Manual revisions 
were published during a particular quarter, our listing will reflect 
that fact.
    Not all revisions to the Coverage Issues Manual contain major 
changes. As with any instruction, sometimes minor clarifications or 
revisions are made within the text. We have reprinted manual revisions 
as transmitted to manual holders. The new text is shown in italics. We 
will not reprint the table of contents, since the table of contents 
serves primarily as a finding aid for the user of the manual and does 
not identify items as covered or not.

III. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of all manual issuances, memoranda, substantive and interpretive 
regulations, or coverage decisions published during the timeframe to 
determine whether any are of particular interest. We expect it to be 
used in concert with previously published notices. Most notably, 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) and the notice published March 31, 1993 (58 FR 16837), 
and those desiring information on the Medicare Coverage Issues Manual 
may wish to review the August 21, 1989, publication.
    To aid the reader, we have organized and divided this current 
listing into five addenda. Addendum I identifies updates that changed 
the Coverage Issues Manual. We published notices in the Federal 
Register that included the text of changes to the Coverage Issues 
Manual. These updates, when added to material from the manual published 
on August 21, 1989, constitute a complete manual as of March 31, 1993. 
Parties interested in obtaining a copy of the manual and revisions 
should follow the instructions in section IV of this notice.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. 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, the Federal Register citation, the title of 
the regulation, and the Parts of the Code of Federal Regulations (CFR) 
which have changed.
    Addendum V sets forth the revisions to the Medicare Coverage Issues 
Manual that were published during the quarter covered by this notice. 
For the revisions, we give a brief synopsis of the revisions as they 
appear on the transmittal sheet, the manual section number, and the 
title of the section. We present a complete copy of the revised 
material, no matter how minor the revision, and identify the revisions 
by printing in italics the text that was changed. If the transmittal 
includes material unrelated to the revised section, for example, when 
the addition of revised material causes other sections to be 
repaginated, we do not reprint the unrelated material.

IV. How To Obtain Listed Material

A. Manuals

    An individual or organization interested in routinely receiving any 
manual and revisions to it may purchase a subscription to that manual. 
Those wishing to subscribe 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 
Order, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 783-
3238, 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.

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 
indicated above. When ordering individual copies, it is necessary to 
cite either the date of publication or the volume number and page 
number.

C. Rulings

    Rulings are published on an infrequent basis by HCFA. Interested 
individuals can obtain copies from the nearest HCFA Regional Office or 
review them at the nearest regional depository library. We also 
sometimes publish Rulings in the Federal Register.

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

    HCFA's laws, regulations, and manuals are now available on CD-ROM, 
which 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 contained on 
the CD-ROM disk:
     Titles XI, XVIII, and XIX of the Act.
     HCFA-related regulations.
     HCFA manuals and monthly revisions.
     HCFA program memoranda.
    The titles are current as of the September 1, 1992, update of the 
Compilation of the Social Security Laws and the regulations are those 
in effect as of October 1, 1993.
    The CD-ROM disk does not contain Appendices M (Interpretative 
Guidelines for Hospices) and R (Resident Assessment for Long Term Care 
Facilities) of the State Operations Manual. Copies of these appendices 
may be reviewed at a Federal Depository Library (FDL).
    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.

V. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local FDL. 
Under the FDL program, government publications are sent to 
approximately 1400 designated libraries throughout the United States. 
Interested parties may examine the documents at any one of the FDLs. 
Some may have arrangements to transfer material to a local library not 
designated as an FDL. To locate the nearest FDL, individuals should 
contact any library.
    In addition, individuals may contact regional depository libraries, 
which receive and retain at least one copy of most Federal government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library.
    Superintendent of Documents numbers for each HCFA publication are 
shown in Addendum III, along with the HCFA publication and transmittal 
numbers. To help FDLs locate the instruction, use the Superintendent of 
Documents number, plus the HCFA transmittal number. For example, to 
find the Carriers Manual, Part 2--Program Administration (HCFA-Pub. 14-
2) transmittal entitled ``The Contractor Performance Evaluation 
Program--FY 1993,'' use the Superintendent of Documents No. HE 22.8/7-
3, and the HCFA transmittal number 123.

VI. General Information

    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. Copies can be purchased or reviewed as 
noted above.
    Questions concerning Medicare items in Addenda III may be addressed 
to Margaret Cotton, Office of Issuances, Health Care Financing 
Administration, Room 688 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5260.
    Questions concerning Medicaid items in Addenda III may be addressed 
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care 
Financing Administration, Room 233 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 965-3246.
    Questions concerning items in Addenda V may be addressed to Walter 
Rutemueller, Office of Coverage and Eligibility Policy, Health Care 
Financing Administration, Room 401 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5395.
    Questions concerning all other information may be addressed to 
Jacqueline Kidd, Regulations Staff, Health Care Financing 
Administration, Room 132 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-4682.

(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: March 7, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Addendum I
    This addendum lists the publication dates of the quarterly listing 
of program issuances and coverage decision updates to the Coverage 
Issues Manual.

March 20, 1990 (55 FR 10290)
February 6, 1991 (56 FR 4830)
July 5, 1991 (56 FR 30752)
November 22, 1991 (56 FR 58913)
January 22, 1992 (57 FR 2558)
March 16, 1992 (57 FR 9127)
June 11, 1992 (57 FR 24797)
October 16, 1992 (57 FR 47468)
January 7, 1993 (58 FR 3028)
March 31, 1993 (58 FR 16837)
July 9, 1993 (58 FR 36967)
September 1, 1993 (58 FR 46200)
December 22, 1993 (58 FR 67796)
Addendum II--Description of Manuals, Memoranda, and HCFA Rulings
    An extensive descriptive listing of Medicare manuals and memoranda 
was published on June 9, 1988, at 53 FR 21730 and supplemented on 
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 
50577. Also, a complete description of the Medicare Coverage Issues 
Manual 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 1993                              
------------------------------------------------------------------------
   Trans. No.               Manual/subject/publication number           
------------------------------------------------------------------------
Intermediary Manual, Part 2 - Audits, Reimbursement Program             
 Administration (HCFA-Pub. 13-2) (Superintendent of Documents No. HE    
 22.8/6-2)                                                              
                                                                        
------------------------------------------------------------------------
394.............   deg. Completion of the Form HCFA-1885A.              
                  The Contractor Performance Evaluation Program--FY     
                   1993.                                                
                  Bill Processing and Service Criterion.                
                  Payment Safeguards Criterion.                         
                  Service Criterion.                                    
                  The RHHI Performance Evaluation Program - FY 1993.    
                  Regional Home Health Intermediary Criterion.          
                                                                        
------------------------------------------------------------------------
 Intermediary Manual, Part 3 - Claims Process (HCFA-Pub. 13-3)          
 (Superintendent of Documents No. HE 22.8/6)                            
                                                                        
------------------------------------------------------------------------
1606............   deg. Electronic Media Claims.                        
                  File Specifications, Record Specifications, and Data  
                   Element Definitions for EMC Bills.                   
                  National Standard Electronic Remittance Advice.       
                  Medicare Standard Electronic PC-Print Software.       
1607............   deg. Bill Review for Partial Hospitalization Services
                   Provided in Community Mental Health Centers.         
                  Hospital Outpatient Partial Hospitalization Services. 
                  Provider Electronic Billing File and Record Formats   
                   HCFA-485 Home Health Certification and Plan of       
                   Treatment.                                           
1608............   deg. PPS PRICER Program.                             
1609............   deg. Review of Form HCFA-1450 for Inpatient and      
                   Outpatient Bills.                                    
                  Billing Procedures for Where Medicare Benefits are    
                   Secondary to Group Health Plans for Employed         
                   Beneficiaries/Spouses and the Disabled.              
                  Coding Structures.                                    
                  MSP Outpatient Claims Involving Lab Charges Paid By   
                   Fee Schedule.                                        
1610............   deg. Rules Governing Charges to Beneficiaries.       
                  The Intermediary Workload Report, Form HCFA-1566.     
1611............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Intermediary Manual, Part 4 - Audit Procedures (HCFA-Pub. 13-3)        
 (Superintendent of Documents No. HE 22.8/6-4)                          
                                                                        
------------------------------------------------------------------------
31..............   deg. Introduction to the Home Health Agency Uniform  
                   Desk Review.                                         
                  Instructions for Performing Desk Reviews.             
32..............   deg. General.                                        
                  Revised Medicare Audit Process.                       
                                                                        
------------------------------------------------------------------------
Carriers Manual, Part 2 - Program Administration (HCFA-Pub. 14-2)       
 (Superintendent of Documents No. HE 22.8/7-3)                          
                                                                        
------------------------------------------------------------------------
123.............   deg. The Contractor Performance Evaluation Program - 
                   FY 1993.                                             
                  Claims Processing Criterion.                          
                  Payment Safeguards Criterion.                         
                  Service Criterion.                                    
                  CWF Host Performance Evaluation Program - FY 1993.    
124.............   deg. Functional Standards for Claims Processing      
                   Operations.                                          
                                                                        
------------------------------------------------------------------------
 Carriers Manual, Part 3 - Claims Process (HCFA-Pub. 14-3)              
 (Superintendent of Documents No. HE 22.8/7)                            
                                                                        
------------------------------------------------------------------------
1465............   deg. List of Covered Surgical Procedures.            
1466............   deg. Requirement for Processing Electronic Media     
                   Claims.                                              
                  The System for Processing Electronic Media Claims.    
                  EMC Testing and Verification.                         
                  Technical Requirements.                               
                  Data Sets and Formats for Electronic Media Claims and 
                   Electronic Remittance Advice.                        
1467............   deg. Bills Involving Medical Assistance Recipients.  
                  Processing Claims for Services of Participating       
                   Physicians or Suppliers.                             
                  Physician and Supplier Billing Requirements for       
                   Services Furnished on or After September 1, 1990.    
                  Participation Program.                                
1468............   deg. Psychological Tests.                            
1469............   deg. The Carrier Performance Report, HCFA-1565.      
1470............   deg. Nonparticipating Physicians to Provide Notices  
                   for Elective Surgery.                                
                  Handling Beneficiary Complaints.                      
1471............   deg. Technical Specifications of the EOMB.           
1472............   deg. Epoetin Furnished to ESRD Home Patients.        
1473............   deg. Introduction.                                   
                  Definition of a Global Surgical Package.              
                  Billing Requirements for Global Surgeries.            
                  Claims Review for Global Surgeries.                   
                  Adjudication of Claims for Global Surgeries.          
                  Postpayment Issues.                                   
                  Claims for Multiple Surgeries.                        
                  Claims for Bilateral Surgeries.                       
                  Procedures Billed With Two or More Surgical Modifiers.
                  Claims for Anesthesia Services Performed On or After  
                   January 1, 1992.                                     
                  Billing for Portable X-Ray Set-Up Services.           
                  Claims Processing System Requirements.                
1474............   deg. Routine Services and Appliances.                
                  Foot Care and Supportive Devices for the Feet.        
                                                                        
------------------------------------------------------------------------
Program Memorandum, Intermediaries (HCFA-Pub. 60A) (Superintendent of   
 Documents No. HE 22.8/6-5)                                             
                                                                        
------------------------------------------------------------------------
A-93-4..........   deg. Change in Hospice Payment Rates.                
A-93-5..........   deg. Health Care Financing Administration's Audit and
                   Cost Report Settlement Expectations.                 
A-93-6..........   deg. FY 1994 Prospective Payment System and Other    
                   Bill Processing Changes.                             
                                                                        
------------------------------------------------------------------------
 Program Memorandum, Carriers (HCFA-Pub. 60B) (Superintendent of        
 Documents No. HE 22.8/6-5)                                             
                                                                        
------------------------------------------------------------------------
B-93-5..........   deg. 1994 Physician, Practitioner and Supplier       
                   Participation Enrollment and Fee Schedule Disclosure.
                                                                        
------------------------------------------------------------------------
 Program Memorandum, Intermediaries/Carriers (HCFA-Pub. 60 A/B)         
 (Superintendent of Documents No. HE 22.8/6-5)                          
                                                                        
------------------------------------------------------------------------
AB-93-5.........   deg. Q Code for New Chemotherapy Drug, Paclitaxel.   
AB-93-6.........   deg. Current Status of Medicare Program Memorandums  
                   and Letters Issued Before Calendar Year 1993.        
AB-93-7.........   deg. Use of New Code, G0001, for Billing of Routine  
                   Venipuncture.                                        
                                                                        
------------------------------------------------------------------------
Program Memorandum, Medicaid State Agencies (HCFA-Pub. 7)               
 (Superintendent of Documents No. HE 22.8/6-5)                          
                                                                        
------------------------------------------------------------------------
93-7............   deg. Current Status of Medicaid Program Memorandums  
                   and Action Transmittals Issued Before Calendar Year  
                   1993.                                                
93-8............   deg. Title XIX, Social Security Act, Medicaid        
                   Coverage and Payment.                                
                                                                        
------------------------------------------------------------------------
State Operations Manual, Provider Certification (HCFA-Pub. 7)           
 (Superintendent of Documents No. HE 22.8/12)                           
                                                                        
------------------------------------------------------------------------
261.............   deg. Life Safety Code Surveys.                       
                  Conducting Initial Surveys and Scheduled Resurveys.   
                                                                        
------------------------------------------------------------------------
Hospital Manual, (HCFA-Pub. 10) (Superintendent of Documents No. HE 22.8/
 2)                                                                     
                                                                        
------------------------------------------------------------------------
655.............   deg. Billing for Hospital Outpatient Partial         
                   Hospitalization Services.                            
                  Coding Structures.                                    
                  Completion of Form HCFA-1450 for Inpatient and/or     
                   Outpatient Billing.                                  
656.............   deg. Focused Medical Review.                         
                  Billing for Part B Outpatient Physical Therapy        
                   Services.                                            
                  Completion of Form HCFA-1450 for Inpatient and/or     
                   Outpatient Billing.                                  
                  Medicare Benefits and Secondary to EGHPs for Employed 
                   Beneficiaries/Spouses and the Disabled.              
                  Coding Structures.                                    
                  MSP Outpatient Claims Involving Lab Charges Paid by   
                   Fee Schedule.                                        
657.............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Home Health Agency Manual (HCFA-Pub. 11) (Superintendent of Documents  
 No. HE 22.8/5)                                                         
                                                                        
------------------------------------------------------------------------
263.............   deg. Billing for Part B Outpatient Physical Therapy  
                   Services.                                            
                  Focused Medical Review.                               
264.............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Skilled Nursing Facility Manual (HCFA-Pub. 12) (Superintendent of      
 Documents No. HE 22.8/3)                                               
                                                                        
------------------------------------------------------------------------
323.............   deg. Focused Medical Review.                         
                  Billing for Part B Intermediary OPT Bills.            
324.............   deg. Rules Governing Charges to Beneficiaries.       
325.............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
Rural Health Clinic and Federally Qualified Health Center Manual (HCFA- 
 Pub. 27) (Superintendent of Documents No. HE 22.8/19:985)              
                                                                        
------------------------------------------------------------------------
8...............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA-Pub. 29)  
 (Superintendent of Documents No. HE 22.8/13)                           
                                                                        
------------------------------------------------------------------------
63..............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Hospice Manual (HCFA-Pub. 21) (Superintendent of Documents No. HE 22.8/
 18)                                                                    
                                                                        
------------------------------------------------------------------------
38..............   deg. Focused Medical Review.                         
39..............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation 
 Facility Manual (HCFA-Pub. 9) (Superintendent of Documents No. HE 22.8/
 9)                                                                     
                                                                        
------------------------------------------------------------------------
112.............   deg. Focused Medical Review.                         
                  Medical Review of Part B OPT Intermediary Bills.      
113.............   deg. Claims Processing Timeliness.                   
                                                                        
------------------------------------------------------------------------
 Coverage Issues Manual (HCFA-Pub. 6) (Superintendent of Documents No.  
 HE 22.8/14)                                                            
                                                                        
------------------------------------------------------------------------
65..............   deg. Artificial Hearts and Related Devices.          
66..............   deg. Medical Documentation.                          
                  Laboratory Evidence.                                  
                                                                        
------------------------------------------------------------------------
 Provider Reimbursement Manual, Part 1 (HCFA-Pub. 15-1) (Superintendent 
 of Documents No. HE 22.8/4)                                            
                                                                        
------------------------------------------------------------------------
373.............   deg. Regional Medicare Swing-Bed SNF Rates.          
374.............   deg. Elimination of Payment for Return of Equity.    
375.............   deg. Costs Not Related to Patient Care.              
                  Political Contribution and Lobbying Activities.       
                  Purpose.                                              
                                                                        
------------------------------------------------------------------------
 Provider Reimbursement Manual, Part 1 - Chapter 27 Reimbursement for   
 ESRD and Transplant Services (HCFA-Pub. 15-1-27) (Superintendent of    
 Documents No. HE 22.8/4)                                               
                                                                        
------------------------------------------------------------------------
24..............   deg. Items and Services Furnished to Direct Dealing  
                   Home Dialysis Beneficiaries.                         
25..............   deg. Epoetin.                                        
                  Infacility Patients.                                  
                  Home Patients.                                        
                                                                        
------------------------------------------------------------------------
Provider Reimbursement Manual, Part II - Provider Cost Reporting Forms  
 and Instructions (Chapter 1) (HCFA-Pub. 15-II) (Superintendent of      
 Documents No. HE 22.8/4)                                               
                                                                        
------------------------------------------------------------------------
16..............   deg. Submission of Cost Report.                      
                                                                        
------------------------------------------------------------------------
 Provider Reimbursement Manual, Part II - Provider Cost Reporting Forms 
 and Instructions (Chapter 28) (HCFA-Pub. 15-II-AB) (Superintendent of  
 Documents No. HE 22.8/4)                                               
                                                                        
------------------------------------------------------------------------
3...............   deg. Form HCFA-2552-92 Worksheets.                   
                  Electronic Reporting Specifications for Form HCFA 2552-
                   92.                                                  
                  Cost Center Coding.                                   
                                                                        
------------------------------------------------------------------------
 Peer Review Organization Manual (HCFA-Pub. 19) (Superintendent of      
 Documents No. HE 8/8-15)                                               
                                                                        
------------------------------------------------------------------------
25..............   deg. Health Care Financing Administration's Role.    
                  Health Care Quality Improvement Initiative.           
                  Generic Quality Screens - Outpatient Surgery.         
                  Rereview of Quality Concerns.                         
                  Scope of PRO Fraud and Abuse Review Activities.       
                  Review Responsibility.                                
                  Evaluation Report.                                    
                  Availability of Expert Witness.                       
                  Reopening of Cases.                                   
26..............   deg. Citations and Authority.                        
                  Issuances of Hospital Notices of Noncoverage.         
                  Content of Hospital-Issued Notice of Noncoverage.     
                  Beneficiary Request for PRO Review.                   
                  Solicitation of Views.                                
                  Monitoring Hospital-Issued Notices of Noncoverage.    
                  Beneficiary Liability.                                
                  Right to a Reconsideration.                           
                  Model Notices of Noncoverage.                         
                  Model Hospital Notice Issued to Beneficiary of Pro    
                   Review of Need for Continued Hospitalization.        
27..............   deg. Monthly Files.                                  
                  Review for Approval of Use of an Assistant at Cataract
                   Surgery.                                             
28..............   deg. Background.                                     
                  Purpose.                                              
                  Report of Findings.                                   
                  Performance Improvement Plan.                         
                                                                        
------------------------------------------------------------------------
State Medicaid Manual, Part 2 - State Organization and General          
 Administration (HCFA-Pub. 45-2) (Superintendent of Documents No. HE    
 22.8/10)                                                               
                                                                        
------------------------------------------------------------------------
84..............   deg. Early and Periodic Screening, Diagnostic and    
                   Treatment Report (Form HCFA-416)                     
                                                                        
------------------------------------------------------------------------
State Medicaid Manual, Part 4 - Services (HCFA-Pub. 45-4)               
 (Superintendent of Documents No. HE 22.8/10)                           
                                                                        
------------------------------------------------------------------------
63..............   deg. Authority to Grant Life Safety Code Waivers for 
                   Medicaid Only Certified NFs.                         
                                                                        
------------------------------------------------------------------------
 State Medicaid Manual, Part 5 - Early and Periodic Screening,          
 Diagnosis, and Treatment (HCFA-Pub. 45-5) (Superintendent of Documents 
 No. HE 22.8/10)                                                        
                                                                        
------------------------------------------------------------------------
6...............   deg. Screening Service Content.                      
7...............   deg. Records or Information on Services and          
                   Recipients Annual Participation Goals.               
                                                                        
------------------------------------------------------------------------
State Medicaid Manual, Part 6 - Payment for Services (HCFA-Pub. 45-6)   
 (Superintendent of Documents No. HE 22.8/10)                           
                                                                        
------------------------------------------------------------------------
24..............   deg. Federal Upper Limit Payments for Multiple Source
                   Drugs.                                               
                                                                        
------------------------------------------------------------------------
State Medicaid Manual, Part 7 - Quality Control (HCFA-Pub. 45-7)        
 (Superintendent of Documents No. HE 22.8/10)                           
                                                                        
------------------------------------------------------------------------
49..............   deg. Definitions of Key Terms.                       
                  Medicaid Eligibility Quality Control Review.          
                  MEQC State and Regional Cycles.                       
                  Cases Which Are Not Reviewed.                         
                  Review of AFDC Cash Cases/Individuals.                
                  In-Person Interview.                                  
                  Mandatory Use of IEVS Information.                    
                  Verification Standards.                               
                  Verification Guide.                                   
                  Administrative Period.                                
                  Technical Errors.                                     
                  Review Month Income Projected Forward Throughout      
                   Spenddown Period.                                    
                                                                        
------------------------------------------------------------------------
 Medicare/Medicaid, Sanction--Reinstatement Report (HCFA-Pub. 69)       
                                                                        
------------------------------------------------------------------------
93-10...........   deg. Report of Physicians/Practitioners, Providers   
                   and/or Other Health Care Suppliers Excluded/         
                   Reinstated.                                          
93-11...........   deg. Report of Physicians/Practitioners, Providers   
                   and/or Other Health Care Suppliers Excluded/         
                   Reinstated.                                          
93-12...........   deg. Report of Physicians/Practitioners, Providers   
                   and/or Other Health Care Suppliers Excluded/         
                   Reinstated.                                          
93-13...........   deg. Report of Physicians/Practitioners, Providers   
                   and/or Other Health Care Suppliers Excluded/         
                   Reinstated.                                          
------------------------------------------------------------------------



                  Addendum IV.--Regulations and Notices Published July Through September 1993                   
----------------------------------------------------------------------------------------------------------------
      Publication date/citation         42 CFR part                             Title                           
----------------------------------------------------------------------------------------------------------------
                                                   Final Rules                                                  
                                                                                                                
----------------------------------------------------------------------------------------------------------------
10/01/93 (58 FR 51408)................     435, 436,  Medicaid Program; Eligibility and Coverage Requirements.  
                                                 440                                                            
10/20/93 (58 FR 54045)................           403  Medicare Program; Demonstration Project to Develop a      
                                                       Uniform Cost Reporting System for Hospitals.             
11/02/93 (58 FR 58502)................     405, 406,  Medicare Program; Self-Implementing Coverage and Payments 
                                           409, 410,   Provisions: 1990 Legislation (Confirmation of Final      
                                           411, 412,   Rule).                                                   
                                           413, 418,                                                            
                                                 489                                                            
11/18/93 (58 FR 60789)................           421  Medicare Program; Carrier Jurisdiction for Claims for     
                                                       Durable Medical Equipment, Prosthetics, Orthotics, and   
                                                       Supplies (DMEPOS).                                       
11/23/93 (58 FR 61816)................     401, 488,  Medicare Program; Granting and Withdrawal of Deeming      
                                                 489   Authority to National Accreditation Organizations.       
12/02/93 (58 FR 63533)................           491  Medicare Program Required Laboratory Procedures for Rural 
                                                       Health Clinics.                                          
12/02/93 (58 FR 63626)................      405, 414  Medicare Program; Revisions to Payment Policies and       
                                                       Adjustments to the Relative Value Units Under the        
                                                       Physician Fee Schedule for Calendar Year 1994.           
12/13/93 (58 FR 65126)................           424  Medicare Program; Intermediary and Carrier Checks That are
                                                       Lost, Stolen, Defaced, Mutilated, Destroyed or Paid on   
                                                       Forged Endorsements.                                     
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                 Proposed Rules                                                 
                                                                                                                
----------------------------------------------------------------------------------------------------------------
10/01/93 (58 FR 51288)................      440, 441  Medicaid Program; Early and Periodic Screening, Diagnosis,
                                                       and Treatment Services Defined.                          
10/15/93 (58 FR 53481)................     431, 440,  Medicaid Program; Case Management.                        
                                            441, 447                                                            
11/26/93 (58 FR 62312)................      410, 411  Medicare Program; Medicare Coverage of Screening Pap      
                                                       Smears for Early Detection of Cervical Cancer.           
12/13/93 (58 FR 65150)................           413  Medicare Program; Reporting of Interest From Zero Coupon  
                                                       Bonds.                                                   
12/14/93 (58 FR 65312)................     435, 436,  Medicaid Program; Extended Medicaid for Certain Families  
                                            440, 447   Who Lose AFDC Eligibility Because of Earned Income; Work 
                                                       Supplementation Participants; Residency of Minor Parents 
                                                       and Pregnant Individuals.                                
12/27/93 (58 FR 68366)................           417  Medicare Program; Retroactive Enrollment and Disenrollment
                                                       in Risk Health Maintenance Organizations and Competitive 
                                                       Medical Plans.                                           
12/29/93 (58 FR 68829)................     410, 417,  Medicare Program; Medicare Coverage and Payment of        
                                                 424   Clinical Psychologist, Other Psychologist, and Clinical  
                                                       Social Worker Services.                                  
----------------------------------------------------------------------------------------------------------------


                                Notices                                 
------------------------------------------------------------------------
Publication date/citation                                               
                                               Title                    
------------------------------------------------------------------------
10/01/93 (58 FR 51355)...  Medicare Program; Payment for Extracorporeal 
                            Shock Wave Lithotripsy Services Furnished by
                            Ambulatory Surgical Centers.                
10/04/93 (58 FR 51632)...  HMOs; Exclusion of Gamete Intrafallopian     
                            Transfer and Zygote Intrafallopian Transfer 
                            as Basic Health Services                    
10/05/93 (58 FR 51827)...  Medicare Program; Data, Standards and        
                            Methodology Used to Establish Fiscal Year   
                            1994 Budgets for Fiscal Intermediaries and  
                            Carriers.                                   
10/05/93 (58 FR 51833)...  HMOs; Qualification Determinations and       
                            Compliance Actions During the Period April  
                            1, 1993, through June 30, 1993.             
10/06/93 (58 FR 52112)...  Medicare, Medicaid, and CLIA Programs;       
                            Clinical Laboratory Improvement Amendments  
                            of 1988 Licensed by the State of Washington.
11/02/93 (58 FR 58553)...  Medicare Programs; Inpatient Hospital        
                            Deductible and Hospital and Extended Care   
                            Services Coinsurance Amounts for 1994.      
11/02/93 (58 FR 58555)...  Medicare Program; Part A Premium for 1994 for
                            the Uninsured Aged and for Certain Disabled 
                            Individuals Who Have Exhausted Other        
                            Entitlement.                                
11/08/93 (58 FR 59271)...  Medicare Program; Monthly Actuarial Rates and
                            Monthly Supplementary Medical Insurance     
                            Premium Rates Beginning January 1, 1994.    
11/16/93 (58 FR 60458)...  Medicare Program; Withdrawal of the Provider 
                            Reimbursement Review Board Hearing Manual.  
11/22/93 (58 FR 61692)...  Medicaid Program; Revised Medicaid Management
                            Information Systems (MMIS) Functional       
                            Requirements.                               
11/24/93 (58 FR 62128)...  Medicare Program; Payment for Extracorporeal 
                            Shock Wave Lithotripsy Services Furnished by
                            Ambulatory Surgical Centers (extension of   
                            comment period).                            
11/26/93 (58 FR 62357)...  Medicare Program; Meeting of the Practicing  
                            Physicians Advisory Council.                
12/02/93 (58 FR 63856)...  Physician Performance Standard Rates of      
                            Increase for Federal Fiscal Year 1994 and   
                            Physician Fee Schedule Update for Calendar  
                            Year 1994.                                  
12/13/93 (58 FR 65186)...  Medicare Program; Peer Review Organization,  
                            General Criteria and Standards for          
                            Evaluating Performance of Contract          
                            Obligations.                                
12/14/93 (58 FR 65357)...  Medicare Program; Proposed Additions to and  
                            Deletions From the Current List of Covered  
                            Procedures for Ambulatory Surgical Centers. 
12/21/93 (58 FR 67350)...  Medicare Program; Changes to the Hospital    
                            Inpatient Prospective Payment Systems and   
                            Fiscal Year 1994 Rates; (Correction).       
12/22/93 (58 FR 67796)...  Medicare and Medicaid Programs; Quarterly    
                            Listing of Program Issuances and Coverage   
                            Decisions--Third Quarter 1993.              
12/23/93 (58 FR 68148)...  Approval of the Commission on Office         
                            Laboratory Accreditation.                   
------------------------------------------------------------------------


Addendum V--Medicare Coverage Issues Manual

(For the reader's convenience, new material and changes to previously 
published material are in italics. If any part of a sentence in the 
manual instruction has changed, the entire line is shown in italics. 
The transmittal includes material unrelated to revised sections. We are 
not reprinting the unrelated material.)

    Transmittal No. 65; section 65-15, Artificial Hearts and Related 
Devices--Not Covered. CHANGED IMPLEMENTING INSTRUCTIONS--EFFECTIVE 
DATE; Services Furnished on or After 10/18/93.
    Section 65-15, Artificial Hearts and Related Devices, is revised to 
provide coverage of the FDA-approved ventricular assist device (known 
as the BVS 5000) when used only in patients suffering from 
postcardiotomy ventricular dysfunction. The device is intended for 
short term use and is not covered when used as a bridge to cardiac 
transplantation.
65-15 ARTIFICIAL HEARTS AND RELATED DEVICES--NOT COVERED
    There are several devices either in use or under development which 
replace all or part of the human heart or assist the heart in 
performing its pumping function. Artificial hearts are considered 
investigational and not covered under Medicare either when used as a 
permanent replacement for a human heart or when used as temporary life-
support systems (i.e., until a human heart becomes available for 
transplant).
    The FDA-approved ventricular assist device (known as the BVS 5000) 
is covered when it is used in accordance with its FDA-approved labeled 
uses for postcardiotomy ventricular dysfunction. The device is intended 
for short term use and is not covered when used as a bridge to cardiac 
transplantation. Other ventricular assist devices used as temporary 
life-support systems are still considered investigational and not 
covered under the Medicare program. Transmittal No. 66; section 60-4.B, 
Medical Documentation. CHANGED PROCEDURES--EFFECTIVE DATE: Services 
furnished on or after 01/01/9.
    Section 60-4.B, Medical Documentation, is revised to reflect 
changes mandated by Sec. 4152 of OBRA 1990, effective for services 
rendered on or after January 1, 1991. Implementing changes were 
published in the Medicare Carriers Manual in July 1991 (transmittal 
1399). Transmittal No. 66; section 60-4.C, Laboratory Evidence. CHANGED 
PROCEDURES--EFFECTIVE DATE: 10/27/93.
    Section 60-4.C, Laboratory Evidence, is revised to indicate that in 
situations where the arterial blood gas and the oximetry studies are 
both used to document the need for oxygen therapy and the results are 
conflicting, the arterial blood gas study is the preferred service of 
documenting medical need because the results of such studies are 
considered the best evidence of hypoxemia. In addition, these 
instructions also clarify that the prohibition against the use of 
results of tests performed by a durable medical equipment (DME) 
supplier to qualify patients for home oxygen service does not extend to 
the results of an arterial blood gas text by a hospital certified to 
conduct such tests.
60-4 HOME USE OF OXYGEN
    B. Medical Documentation.--Initial claims for oxygen services must 
include a completed Form HCFA-484 (Attending Physician's Certification 
of Medical Necessity for Home Oxygen Therapy) to establish whether 
coverage criteria are met and to ensure that the oxygen services 
provided are consistent with the physician's prescription or other 
medical documentation. The attending physician's prescription or other 
medical documentation must indicate that the other forms of treatment 
(e.g., medical and physical therapy directed at secretions, 
bronchospasm and infection) have been tried, have not been sufficiently 
successful, and oxygen therapy is still required. While there is no 
substitute for oxygen therapy, each patient must receive optimum 
therapy before long-term home oxygen therapy is ordered. Use Form HCFA-
484 for recertifications. (See Medicare Carriers Manual Sec. 3312 for 
completion of Form HCFA-484.)
    The medical and prescription information on Form HCFA-484 can be 
completed only by the attending physician or entered on the form from 
information in the patient's records by an employee of the physician 
for the physician's review and signature. Although hospital discharge 
coordinators, nurses, and medical social workers may assist in 
arranging for physician-prescribed home oxygen, they have no authority 
to prescribe the services or to enter medical or prescription 
information in items 1 through 6 of Form HCFA-484. Suppliers may not 
enter this information either.
    Unlike other types of DME, a physician's certification of medical 
necessity for oxygen equipment must include the results of specific 
testing before coverage can be determined.
    Initial claims for oxygen must also be supported by medical 
documentation. Separate documentation is used with electronic billing. 
(See Medicare Carriers Manual, Part 3, Sec. 4105.6.) This documentation 
may be in the form of a prescription written by the patient's attending 
physician who has recently examined the patient (normally within a 
month of the start of therapy) and must specify:
     A diagnosis of the disease requiring home use of oxygen;
     The oxygen flow rate; and
     An estimate of the frequency, duration of use (e.g., 2 
liters per minute, 10 minutes per hour, 12 hours per day), and duration 
of need (e.g., 6 months or lifetime).

    Note: A prescription for ``Oxygen PRN'' or ``Oxygen as needed'' 
does not meet this last requirement. Neither provides any basis for 
determining if the amount of oxygen is reasonable and necessary for 
the patient.

    All claims with oxygen flow rates of more than 2 liters per minute 
must be reviewed by a carrier's medical staff before payment can be 
made. The attending physician may also specify the type of oxygen 
delivery system to be used (i.e., gas, liquid, or concentrator). If the 
type of system is specified, then the medical reasons for selecting 
that system over the alternative systems must also be specified.
    New medical documentation written by the patient's attending 
physician must be submitted to the carrier in support of revised oxygen 
requirements when there has been a change in the patient's condition 
and need for oxygen therapy.
    Carriers are required to conduct periodic, continuing medical 
necessity reviews on patients whose conditions warrant these reviews 
and on patients with indefinite or extended periods of necessity as 
described in Medicare Carriers Manual, Part 3, Sec. 4105.6.C. When 
indicated, carriers may also request documentation of the results of a 
repeat arterial blood gas or oximetry study.

    Note: Section 4152 of OBRA 1990 requires earlier recertification 
and retesting of oxygen patients who begin coverage with an arterial 
blood gas result at or above a partial pressure of 55 or an arterial 
oxygen saturation percentage at or above 89. (See Medicare Carriers 
Manual Sec. 4105.6 for certifications and retesting schedules.)

    C. Laboratory Evidence.--Initial claims for oxygen therapy must 
also include the results of a blood gas study that has been ordered and 
evaluated by the attending physician. This is usually in the form of a 
measurement of the partial pressure of oxygen (PO2) in arterial blood. 
(See Medicare Carriers Manual, Part 3, Sec. 2070.1 for instructions on 
clinical laboratory tests.) A measurement of arterial oxygen saturation 
obtained by ear or pulse oximetry, however, is also acceptable when 
ordered and evaluated by the attending physician and performed under 
his or her supervision or when performed by a qualified provider or 
supplier of laboratory services. In situations when the arterial blood 
gas and the oximetry studies are both used to document the need for 
home oxygen therapy and the results are conflicting, the arterial blood 
gas study is the preferred source of documenting medical need. A DME 
supplier is not considered a qualified provider or supplier of 
laboratory services for purposes of these guidelines. This prohibition 
does not extend to the results of an arterial blood gas test conducted 
by a hospital certified to do such tests. The conditions under which 
the laboratory tests are performed must be specified in writing and 
submitted with the initial claim, i.e., at rest, while sleeping, while 
exercising, on room air, or if while on oxygen, the amount, body 
position during testing, and similar information necessary for 
interpreting the evidence as specified by the carrier.
    The preferred sources of laboratory evidence are existing physician 
and/or hospital records that reflect the patient's medical condition. 
Since it is expected that virtually all patients who qualify for home 
oxygen coverage for the first time under these guidelines have recently 
been discharged from a hospital where they submitted to arterial blood 
gas tests, the carrier needs to request that such test results be 
submitted in support of their initial claims for home oxygen. If more 
than one arterial blood gas test is performed during the patient's 
hospital stay, the test result obtained closest to the hospital 
discharge date is the best evidence of the need for home oxygen 
therapy.
    Carriers may accept an attending physician's statement of recent 
hospital test results for a particular patient, when appropriate, in 
lieu of copies of actual hospital records. Subsequent blood gas tests 
that appear to duplicate the hospital test (e.g., when there is no 
reason to believe the patient's condition may have changed) are denied 
as not medically reasonable and necessary.
    A repeat arterial blood gas or oximetry study is normally necessary 
only when evidence indicates that an oxygen recipient has undergone a 
major change relevant to home use of oxygen. For example, if the 
carrier has reason to believe that there has been a major change in the 
patient's physical condition (e.g., when there has been a significant 
increase in the amount of oxygen billed on a monthly basis), it may ask 
for documentation of the results of another blood gas or oximetry 
study.

[FR Doc. 94-6153 Filed 3-16-94; 8:45 am]
BILLING CODE 4120-01-P