[Federal Register Volume 61, Number 149 (Thursday, August 1, 1996)]
[Notices]
[Pages 40236-40242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19559]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-139-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances and Coverage Decisions--First Quarter 1996

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 January, February, and 
March of 1996 that relate to the Medicare and Medicaid programs. It 
also identifies certain devices with investigational device exemption 
numbers approved by the Food and Drug Administration that may be 
potentially covered under Medicare.
    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 time frame. Generally, we 
also provide the content of revisions to the Medicare Coverage Issues 
Manual. There were no revisions published during the period January 1 
through March 31, 1996. On August 21, 1989, we published the content of 
the Manual (54 FR 34555) 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 fulfills this requirement in a 
manner that facilitates identification of coverage and other changes in 
our manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 786-5255 (For Medicare instruction information).
Pat Prete, (410) 786-3246 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Cathy Johnson, (410) 786-5241 (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 38 million Medicare beneficiaries and 36 
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 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 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 time frame. 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 list in this notice Medicaid issuances and Medicaid 
substantive and interpretive regulations published during January 
through March 1996.

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 many of 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

[[Page 40237]]

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. This notice contains, as Addendum 
IV, reprinted manual revisions as transmitted to manual holders. The 
new text is shown in italics. We have not reprinted 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, coverage decisions, or Food and Drug Administration-
approved investigational device exemptions published during the time 
frame 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 (54 FR 34555).
    To aid the reader, we have organized and divided this current 
listing into six 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 the end of the 
quarter covered by this notice. 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 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.
    Addendum V 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 parts of 
the Code of Federal Regulations (CFR) that have changed (if 
applicable), the agency file code number, the title of the regulation, 
the ending date of the comment period (if applicable), and the 
effective date (if applicable).
    On September 19, 1995, we published a final rule (60 FR 48417) 
establishing in regulations that certain devices with an 
investigational device exemption approved by the Food and Drug 
Administration and certain services related to those devices may be 
covered under Medicare. That final rule states that we will announce in 
this quarterly notice all investigational device exemption 
categorizations, using the investigational device exemption numbers the 
Food and Drug Administration assigns. Addendum VI includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved during the quarter covered by 
this notice. 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 investigational device exemption number). 
Future notices will announce investigational device exemption 
categorizations and the numbers assigned by the Food and Drug 
Administration for the quarter for which the notices cover.

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) 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.

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 (1) the

[[Page 40238]]

World Wide Web--the Superintendent of Documents home page address is 
http://www.access.gpo.gov/su__docs/; (2) local WAIS client software, or 
(3) telnet--swais.access.gpo.gov, then login as guest (no password 
required). Dial-in users should use communications software and modem 
to call (202) 512-1661; type swais, then login as guest (no password 
required). For general information about GPO Access, contact the GPO 
Access User Support Team by sending Internet e-mail to [email protected]
gpo.gov; by faxing to (202) 512-1262; or by calling (202) 512-1530 
between 7 a.m. and 5 p.m. Eastern time, Monday-Friday, except for 
Federal holidays.

C. Rulings

    We publish Rulings on an infrequent basis. 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)

    Our laws, regulations, and manuals are also 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 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 of the Compilation of the Social Security Laws are 
current as of January 1, 1995. 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.

V. 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 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, 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 3--
Claims Process (HCFA-Pub. 14-3) transmittal entitled ``Beneficiary 
Address Change,'' use the Superintendent of Documents No. HE 22.8/7 and 
the HCFA transmittal number 1538.

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, Bureau of Program Operations, Issuances Staff, 
Health Care Financing Administration, S3-01-27, 7500 Security Blvd., 
Baltimore, MD 21244-1850, Telephone (410) 786-5255.
    Questions concerning Medicaid items in Addenda III may be addressed 
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care 
Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore, 
MD 21244-1850, Telephone (410) 786-3246.
    Questions concerning Food and Drug Administration-approved 
investigational device exemptions may be addressed to Sharon Hippler, 
Bureau of Policy Development, Office of Chronic Care and Insurance 
Policy, Health Care Financing Administration, C4-11-04, 7500 Security 
Blvd., Baltimore, MD 21244-1850, Telephone (410) 786-4633.
    Questions concerning all other information may be addressed to 
Cathy Johnson, Bureau of Policy Development, Office of Regulations, 
Health Care Financing Administration, C5-09-05, 7500 Security Blvd., 
Baltimore, MD 21244-1850, Telephone (410) 786-5241.

(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: July 19, 1996.
Carol J. Walton,
Director, Bureau of Program Operations.

Addendum I

    This addendum lists the publication dates of the most recent 
quarterly listing of program issuances and coverage decision updates to 
the Coverage Issues Manual. For a complete listing of the quarterly 
updates to the Coverage Issues Manual published during March 20, 1990 
through November 14, 1994, please refer to the January 3, 1995 update 
(60 FR 134).

January 3, 1995 (60 FR 132)
April 6, 1995 (60 FR 17538)
July 26, 1995 (60 FR 38344)
November 15, 1995 (60 FR 57435)
April 8, 1996 (61 FR 154)
June 26, 1996 (61 FR 33119)

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.

[[Page 40239]]



 Addendum III--Medicare and Medicaid Manual Instructions January Through
                               March 1996                               
------------------------------------------------------------------------
       Trans. No.               Manual/Subject/Publication Number       
------------------------------------------------------------------------
                           Intermediary Manual                          
                 Part 3--Claims Process (HCFA Pub. 13-3)                
              (Superintendent of Documents No. HE 22.8/6-1)             
                                                                        
------------------------------------------------------------------------
1671...................   Claims Processing Terminology.        
                          Handling Incomplete or Invalid Claims.        
                          Data Element Requirements Matrix.             
1672...................   PRO Reporting on Medical Review.      
1673...................   Guidelines for Review of Claims for   
                          Epoetin.                                      
                                                                        
------------------------------------------------------------------------
                            Carriers Manual                             
                Part 3--Claims Process (HCFA Pub. 14-3)                 
              (Superintendent of Documents No. HE 22.8/7)               
                                                                        
------------------------------------------------------------------------
1533...................   Nomenclature and Organization of the  
                          List.                                         
                           Rebundling of CPT Codes.                     
                           Added ASC Codes.                             
1534...................   Positron Emission Tomography Scans.   
                           Billing Requirements for PET Scans.          
                           Claims Processing Instructions for PET Scan  
                          Claims.                                       
1535...................   Claims Processing Terminology.        
                           Handling Incomplete or Invalid Claims.       
                           Data Element Requirements Matrix.            
                           Conditional Data Element Requirements.       
1536...................   Reasonableness and Necessity.         
1537...................   Item 24--Type of Service.             
1538...................   Beneficiary Address Change.           
                                                                        
------------------------------------------------------------------------
                            Carriers Manual                             
            Part 4--Professional Relations (HCFA Pub. 14-4)             
             (Superientendent of Documents No. HE 22.8/7-4)             
                                                                        
------------------------------------------------------------------------
11.....................   Items 1-13--Patient and Insured       
                          Information.                                  
                           Items 14-33--Physician or Supplier           
                          Information.                                  
                           Place of Service Codes and Definitions.      
                                                                        
------------------------------------------------------------------------
                           Program Memorandum                           
                Intermediaries/Carriers (HCFA Pub. 60B)                 
             (Superintendent of Documents No. HE 22.8/6-5)              
                                                                        
------------------------------------------------------------------------
B-96-1.................   Coverage for Occupational Therapists  
                          in Independent Practice.                      
                                                                        
------------------------------------------------------------------------
                           Progam Memorandum                            
                       Carriers (HCFA Pub. 60A/B)                       
             (Superintendent of Documents No. HE 22.8/6-5)              
                                                                        
------------------------------------------------------------------------
AB-96-1................   New Interest Rate Payable on Clean    
                          Claims Not Paid Timely.                       
AB-96-2................   Exclusion Process, Sec.  1128(b)(7).  
                                                                        
------------------------------------------------------------------------
                           Progam Memorandum                            
                 Insurance Commissioners (HCFA Pub. 80)                 
             (Superintendent of Documents No. HE 22.8/6-5)              
                                                                        
------------------------------------------------------------------------
96-1...................   Medigap Bulletin Series (Number Five).
                                                                        
------------------------------------------------------------------------
                        Peer Review Organization                        
                             (HCFA Pub. 19)                             
             (Superintendent of Documents No. HE 22.8/8-15)             
                                                                        
------------------------------------------------------------------------
58.....................   Background.                           
                           Beneficiary Hotline.                         
                           Interaction with Beneficiary Groups.         
                           Other Activities.                            
59.....................   PRO Reporting on Medical Review.      
                           Tracking Adjustments.                        
                           PRO/Intermediary/Carrier Coordination        
                          Activities.                                   
                           Additional PRO/Carrier Coordination          
                          Activities.                                   
60.....................   Background.                           

[[Page 40240]]

                                                                        
                           PRO Review Responsibilities.                 
                           Types of Prohibited Actions That Circumvent  
                          PPS.                                          
                           Actions to be Taken by PRO.                  
                           Authority.                                   
                           Types of Denial Determinations.              
                           Notification of Denial.                      
                           Content of Denial Notice.                    
                           Statutory and Regulatory Requirements.       
                           Requests for Reconsideration.                
                           Reconsideration Process.                     
                           Circumvention of Prospective Payment System. 
                           Background.                                  
                           Appeals Council Review.                      
                           Judicial Review.                             
                           Circumvention of PPS Denial Model Notice.    
                           Circumvention of PPS Reconsideration Model   
                          Notice.                                       
61.....................   Training.                             
                           Citations and Authority.                     
                                                                        
------------------------------------------------------------------------
                             Hospice Manual                             
                             (HCFA Pub. 21)                             
              (Superintendent of Documents No. HE 22.8/18)              
                                                                        
------------------------------------------------------------------------
47.....................   Credit Balance Reporting Requirements.
                           Payment of Amounts Owed Medicare.            
                           Medicare Credit Balance Report Certification.
                          Medicare Credit Balance Report (HCFA-838)     
                                                                        
------------------------------------------------------------------------
                     Provider Reimbursement Manual                      
                        Part 1--(HCFA Pub.15-1)                         
              (Superintendent of Documents No. HE 22.8/4)               
                                                                        
------------------------------------------------------------------------
389....................   Travel Expense.                       
390....................   Regional Medicare Swing-Bed SNF Rates.        
391....................   Interest.                                     
                           Necessary.                                   
                           Accounts Receivable Financing.               
                           Costs Included in Capital-Related Costs.     
                           Capital Related Costs of Related             
                          Organizations.                                
                           Debt Issuance Costs, Debt Discounts, and Debt
                          Redemption Costs.                             
                           Costs Excluded From Capital-Related Costs.   
                           Jointly Owned Equipment.                     
                           Unpaid Compensation.                         
392....................   Ambulance Service.                    
                                                                        
------------------------------------------------------------------------
                           Medicare/Medicaid                            
                     Sanction--Reinstatement Report                     
                             (HCFA Pub. 69)                             
                                                                        
------------------------------------------------------------------------
96-1...................   Cumulative Report of Physicians/      
                          Practitioners, Providers and/or Other Health  
                          Care Suppliers Sanctioned/Reinstated.         
96-2...................   Report of Physicians/Practioners,     
                          Providers and/or Other Health Care Suppliers  
                          Excluded/Reinstated--December 1995 and January
                          1996.                                         
96-3...................   Report of Physicians/Practitioners,   
                          Providers and/or Other Health Care Suppliers/ 
                          Reinstated--February 1996.                    
------------------------------------------------------------------------



Addendum IV

    There are no revisions to the Coverage Issues Manual for this 
quarter.

                       Addendum V.--Regulation Documents Published in the Federal Register                      
----------------------------------------------------------------------------------------------------------------
                                                                                           End of               
 Publication date  FR Vol. 61      CFR Part           File code *         Regulation      comment     Effective 
                      page                                                  title          period        date   
----------------------------------------------------------------------------------------------------------------
01/19/96.........   1389-1390  ................  BPD-854-NC            Medicare and        03/19/96     01/19/96
                                                                        Medicaid                                
                                                                        Programs;                               
                                                                        Announcement                            
                                                                        of                                      
                                                                        Applications                            
                                                                        from Hospitals                          
                                                                        Requesting                              
                                                                        Waivers for                             
                                                                        Organ                                   
                                                                        Procurement                             
                                                                        Service Area.                           
01/23/96.........   1769-1772  ................  ORD-083-N             New and Pending  ...........  ...........
                                                                        Demonstration                           
                                                                        Project                                 
                                                                        Proposals                               
                                                                        Submitted                               
                                                                        Pursuant to                             
                                                                        Section                                 
                                                                        1115(a) of the                          
                                                                        Social                                  
                                                                        Security Act:                           
                                                                        November 1995.                          

[[Page 40241]]

                                                                                                                
01/26/96.........   2516-2519  ................  BPO-134-NC            Medicare            02/26/96     02/01/96
                                                                        Program;                                
                                                                        Revised                                 
                                                                        Criteria and                            
                                                                        Standards for                           
                                                                        Evaluating                              
                                                                        Durable                                 
                                                                        Medical                                 
                                                                        Equipment,                              
                                                                        Prosthetics,                            
                                                                        Orthotics, and                          
                                                                        Supplies                                
                                                                        Regional                                
                                                                        Carriers'                               
                                                                        Performance                             
                                                                        Beginning                               
                                                                        February 1,                             
                                                                        1996.                                   
01/26/96.........        2516  ................  ORD-078-N             Medicare         ...........  ...........
                                                                        Program;                                
                                                                        Announcement                            
                                                                        of Funding                              
                                                                        Availability                            
                                                                        for a                                   
                                                                        Cooperative                             
                                                                        Agreement for                           
                                                                        an End-Stage                            
                                                                        Renal Disease                           
                                                                        (ESRD) Managed                          
                                                                        Care                                    
                                                                        Demonstration.                          
01/29/96.........   2725-2727  412, 413........  BPD-825-FCN           Medicare         ...........     10/01/95
                                                                        Program;                                
                                                                        Changes to the                          
                                                                        Hospital                                
                                                                        Inpatient                               
                                                                        Prospective                             
                                                                        Payment                                 
                                                                        Systems and                             
                                                                        Fiscal Year                             
                                                                        1996 Rates;                             
                                                                        Corrections.                            
02/27/96.........        7266  ................  ORD-084-N             New and Pending  ...........  ...........
                                                                        Demonstration                           
                                                                        Project                                 
                                                                        Proposals                               
                                                                        Submitted                               
                                                                        Pursuant to                             
                                                                        Section                                 
                                                                        1115(a) of the                          
                                                                        Social                                  
                                                                        Security Act:                           
                                                                        December 1995.                          
02/29/96.........        7798  ................  ORD-085-N             New and Pending  ...........  ...........
                                                                        Demonstration                           
                                                                        Project                                 
                                                                        Proposals                               
                                                                        Submitted                               
                                                                        Pursuant to                             
                                                                        Section                                 
                                                                        1115(a) of the                          
                                                                        Social                                  
                                                                        Security Act:                           
                                                                        January 1996.                           
03/08/96.........   9405-9410  440.............  MB-071-P              Medicare            05/07/96  ...........
                                                                        Program;                                
                                                                        Coverage of                             
                                                                        Personal Care                           
                                                                        Services.                               
03/27/96.........  13430-1345  417,434.........  OMC-010-FC            Medicare and        05/28/96    04/26/96 
                            0                                           Medicaid                                
                                                                        Programs;                               
                                                                        Requirements                            
                                                                        for Physician                           
                                                                        Incentive                               
                                                                        Plans in                                
                                                                        Prepaid Health                          
                                                                        Care                                    
                                                                        Organizations.                          
----------------------------------------------------------------------------------------------------------------
* GN--General Notice; PN--Proposed Notice; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final  
  Rule; FC--Final Rule with Comment Period; CN--Correction Notice; SN--Suspension Notice; WN--Withdrawal Notice;
  NR--Notice of HCFA Ruling.                                                                                    



Addendum VI.--Categorization of Food and Drug Administration-Approved 
Investigational Device Exemptions

    Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices 
fall into one of three classes:
    Class I--Devices for which the general controls of the Food, Drug, 
and Cosmetic Act, such as adherence to good manufacturing practice 
regulations, are sufficient to provide a reasonable assurance of safety 
and effectiveness.
    Class II--Devices that, in addition to general controls, require 
special controls, such as performance standards or postmarket 
surveillance, to provide a reasonable assurance of safety and 
effectiveness.
    Class III--Devices that cannot be classified into Class I or Class 
II because insufficient information exists to determine that either 
special or general controls would provide reasonable assurance of 
safety and effectiveness. Class III devices require premarket approval.
    Under the new categorization process to assist HCFA, the Food and 
Drug Administration assigns each device with a Food and Drug 
Administration-approved investigational device exemption to one of two 
categories: Experimental/Investigational (Category A) Devices, or Non-
Experimental/Investigational (Category B) Devices. Under this 
categorization process, an experimental/investigational (Category A) 
device is an innovative device in Class III for which ``absolute risk'' 
of the device type has not been established (that is, initial questions 
of safety and effectiveness have not been resolved and the Food and 
Drug Administration is unsure whether the device type can be safe and 
effective). A non-experimental/investigational (Category B) device is a 
device believed to be in Class I or Class II, or a device believed to 
be in Class III for which the incremental risk is the primary risk in 
question (that is, underlying questions of safety and effectiveness of 
that device type have been resolved), or it is known that the device 
type can be safe and effective because, for example, other 
manufacturers have obtained Food and Drug Administration approval for 
that device type.
    The criteria the Food and Drug Administration uses to categorize an 
investigational device under Category B include the following:
    (1) Devices, regardless of the classification, under investigation 
to establish substantial equivalence to a predicate device, that is, to 
establish substantial equivalence to a previously/currently legally 
marketed device.
    (2) Class III devices whose technological characteristics and 
indication for use are comparable to a Pre-Market Approval (PMA)-
approved device.
    (3) Class III devices with technological advances compared to a 
PMA-approved device, that is, a device with technological changes that 
represent advances to a device that has already received PMA-approval 
(generational changes).
    (4) Class III devices that are comparable to a PMA-approved device 
but are under investigation for a new indication for use. For purposes 
of studying the new indication, no significant modification to the 
device were required.
    (5) Pre-amendments Class III devices that become the subject of an 
investigational device exemption after the Food and Drug Administration 
requires premarket approval, that is, no PMA application was submitted 
or the PMA application was denied.
    (6) Nonsignificant risk device investigations for which the Food 
and Drug Administration required the submission of an investigational 
device exemption.
    The following information presents the device number, category (in 
this case, A), and criterion code. G950168 A2, G950175 A1, G960026 A2, 
G960033 A1, G960034 A1, G960055 A2, G960060 A1, G960066 A2
    The following information presents the device number, category (in 
this case, B), and criterion code. G950194 B1, G950210 B1, G950212 B3, 
G950217 B1, G950218 B1, G950229 B3, G950231 B, G960003 B4, G960018 B4, 
G960019 B4, G960021 B2, G960022 B4, G960023 B2, G960024 B3, G960025 B2, 
G960027 B4, G960028 B1, G960029 B4, G960030 B2, G960031 B2, G960035 B4, 
G960037 B4, G960038 B4, G960041 B4, G960043

[[Page 40242]]

B1, G960046 B1, G960051 B3, G960054 B3, G960056 B5, G960057 B2, G960059 
B2, G960061 B2, G960062 B2

    Note: Some investigational devices may exhibit unique 
characteristics or raise safety concerns that make additional 
consideration necessary. For these devices, HCFA and the Food and 
Drug Administration will agree on the additional criteria to be 
used. The Food and Drug Administration will use these criteria to 
assign the device(s) to a category. As experience is gained in the 
categorization process, this addendum may be modified.

[FR Doc. 96-19559 Filed 7-31-96; 8:45 am]
BILLING CODE 4120-01-P