[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Pages 62325-62332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30568]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[BPO-151-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--Second Quarter 1997

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 that were 
published during April, May, and June of 1997 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

[[Page 62326]]

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.

FOR FURTHER INFORMATION CONTACT:

Bridget Wilhite, (410) 786-5248 (For Medicare instruction information).
Betty Stanton, (410) 786-3247 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Pam Gulliver, (410) 786-4659 (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, 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 April through June 1997.

II. 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 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 five addenda. Addendum I lists the publication dates of 
the most recent quarterly listings of program issuances.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published 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 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 at 42 CFR 405.201 et seq. 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. It is HCFA's practice to announce in 
this quarterly notice all investigational device exemption 
categorizations, using the investigational device exemption numbers the 
Food and Drug Administration assigns. Addendum V includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved or revised 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).

III. 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, TTN: New 
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825 
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell. 
Additionally, all manuals are available at the following Internet 
address: http//www.hcfa.gov/pubforms/progman.htm.

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

[[Page 62327]]

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

C. Rulings

    We publish Rulings on an infrequent basis. Interested individuals 
can obtain copies from the nearest HCFA Regional Office or review them 
at the nearest regional depository library. We have, on occasion, 
published Rulings in the Federal Register. In addition, Rulings, 
beginning with those released in 1995, are available online, through 
the HCFA Home Page. The Internet address is <a href="http://www.hcfa.gov/regs/
rulings.htm">http://www.hcfa.gov/regs/
rulings.htm</a>.

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:
    <bullet> Titles XI, XVIII, and XIX of the Act.
    <bullet> HCFA-related regulations.
    <bullet> HCFA manuals and monthly revisions.
    <bullet> 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.

IV. How to Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 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 Intermediary Manual, Part 
2--Audits, Reimbursement Program Administration (HCFA Pub. 13-2) 
transmittal entitled ``Maximum Payment Per Visit For Rural Health 
Clinics,'' use the Superintendent of Documents No. HE 22.8/6-2 and the 
HCFA transmittal number 409.

V. 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 Addendum III may be 
addressed to Bridget Wilhite, Office of Communications and Operations 
Support, Division of Regulations and Issuances, Health Care Financing 
Administration, Telephone (410) 786-5248.
    Questions concerning Medicaid items in Addendum III may be 
addressed to Betty Stanton, Center for Medicaid State Operations, 
Policy Coordination and Planning Group, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-3247.
    Questions concerning Food and Drug Administration-approved 
investigational device exemptions may be addressed to Sharon Hippler, 
Office of Clinical Standards and Quality, Coverage Analysis Group, 
Health Care Financing Administration, C4-11-04, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.
    Questions concerning all other information may be addressed to Pam 
Gulliver, Office of Communications and Operations Support, Division of 
Regulations and Issuances, Health Care Financing Administration, C5-09-
26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 
786-4659.

(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: October 31, 1997.
Pamela J. Gentry,
Director, Office of Communications and Operations Support.

Addendum I

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

June 26, 1996 (61 FR 33119)
December 18, 1996 (61 FR 66676)
April 21, 1997 (62 FR 19328)
May 12, 1997 (62 FR 25957)
November 3, 1997 (62 FR 59358)

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 62328]]



         Addendum III--Medicare and Medicaid Manual Instructions        
                     [April 1997 through June 1997]                     
------------------------------------------------------------------------
   Trans. No.                     Manual/Subject/Publication No.        
------------------------------------------------------------------------
                           Intermediary Manual                          
          Part 2--Audits, Reimbursement Program Administration          
                            (HCFA Pub. 13-2)                            
             (Superintendent of Documents No. HE 22.8/6-2)              
------------------------------------------------------------------------
409               <bulle  Maximum Payment Per Visit For Rural Health    
                      t    Clinics.                                     
                  <bulle  Maximum Payment Per Visit For Freestanding    
                      t    Federally Qualified Health Centers.          
410               <bulle  List of MR Codes, Categories, and Conversion  
                      t    Factors.                                     
------------------------------------------------------------------------
                          Intermediary Manual                           
                         Part 3--Claims Process                         
                            (HCFA Pub. 13-3)                            
               (Superintendent of Documents No. HE 22.8/6)              
------------------------------------------------------------------------
1709              <bulle  Pneumococcal Pneumonia, Influenza Virus and   
                      t    Hepatitis B Vaccines.                        
1710              <bulle  Review of Form HCFA-1450 For Inpatient and    
                      t    Outpatient Bills.                            
                          Self-Administered Drugs and Biologicals.      
                          Oral Cancer Drugs.                            
                          Self-Administered Antiemetic Drugs.           
                          Mammography Quality Standards Act.            
                          Self-Administered Drug Administered In An     
                           Emergency Situation.                         
                          Hospital Outpatient Partial Hospitalization   
                           Services.                                    
1711              <bulle  Special Consideration When Processing ESRD    
                      t    Bills Under Method I.                        
                          Special Consideration When Processing ESRD    
                           Bills Under Method II.                       
                          Medical--Subject to Waiver.                   
1712              <bulle  Drugs and Biologicals.                        
                      t                                                 
1713              <bulle  Pneumoccal Pneumonia, Influenza Virus, and    
                      t    Hepatitis B Vaccines.                        
1714              <bulle  Laboratory Test for Hemodialysis, Intermittent
                      t    Peritoneal Dialysis, Continuous Cycling      
                           Peritoneal Dialysis, and Hemofiltration.     
------------------------------------------------------------------------
                            Carriers Manual                             
                Part 3--Claims Process (HCFA Pub. 14-3)                 
              (Superintendent of Documents No. HE 22.8/7)               
------------------------------------------------------------------------
1564              <bulle  Coverage of Supplies and Accessories.         
                      t                                                 
                          New Supplier Effective Billing Date.          
1565              <bulle  Assignment of a Partially Paid Bill.          
                      t                                                 
1566              <bulle  Method for Computing Fee Schedule Amount.     
                      t                                                 
                          Bundled Services/Supplies.                    
                          Supervising Physicians in Teaching Settings.  
                          Anesthesia Claims Modifiers.                  
                          Services of Portable X-ray Suppliers.         
                          Special Situations.                           
                          Interpretation of Diagnostic Tests.           
1567              <bulle  Completing Quarterly Report on Provider       
                      t    Enrollment.                                  
1568              <bulle  Screening Mammography Examinations.           
                      t                                                 
                          Identifying a Screening Mammography Claim.    
                          Adjudicating the Claim.                       
1569              <bulle  Bill Review of Laboratory Services.           
                      t                                                 
1570              <bulle  Self-Administered Drug and Biologicals.       
                      t                                                 
1571              <bulle  Paper Remittance Notice.                      
                      t                                                 
1572              <bulle  Bill Review of Laboratory Services.           
                      t                                                 
------------------------------------------------------------------------
                           Program Memorandum                           
                     Intermediaries (HCFA Pub. 60A)                     
              (Superintendent of Documents No. HE 22.8/6-5)             
------------------------------------------------------------------------
A-97-4            <bulle  Two Month Extension for Implementation of     
                      t    Filing Electronically Prepared Cost Reports  
                           for Skilled Nursing Facilities and Home      
                           Health Agencies.                             
------------------------------------------------------------------------
                           Program Memorandum                           
               Intermediaries/Carriers (HCFA Pub. 60A/B)                
              (Superintendent of Documents No. HE 22.8/6-5)             
------------------------------------------------------------------------
AB-97-6           <bulle  Current Status of Medicare Program Memorandums
                      t    And Letters Issued Before Calendar Year 1997.
AB-97-7           <bulle  Revision on Program Memorandum Transmittal No.
                      t    AB-97-5, New Panels Approved by CPT.         
AB-97-8           <bulle  Hematocrit Levels for Erythropoietin.         
                      t                                                 

[[Page 62329]]

                                                                        
AB-97-9           <bulle  New Code for HIV-1 Viral Load Testing.        
                      t                                                 
------------------------------------------------------------------------
                           Program Memorandum                           
                        Medicaid State Agencies                         
                             (HCFA Pub. 17)                             
              (Superintendent of Documents No. HE 22.8/6-5)             
------------------------------------------------------------------------
97-1              <bulle  Current Status of Medicaid Program Memorandums
                      t    and Action Transmittals Issues Before        
                           Calendar Year 1997.                          
------------------------------------------------------------------------
                           Program Memorandum                           
                            Regional Offices                            
                             (HCFA Pub. 54)                             
           (Superintendent of Documents No. HE 22.28/5:90-1)            
------------------------------------------------------------------------
97-1              <bulle  Civil Money Penalty Collection Procedures.    
                      t                                                 
------------------------------------------------------------------------
                        State Operations Manual                         
                         Provider Certification                         
                             (HCFA Pub. 7)                              
              (Superintendent of Documents No. HE 22.8/12)              
------------------------------------------------------------------------
281               <bulle  Interpretive Guidelines--Home Health Agencies.
                      t                                                 
282               <bulle  Model Letter to Provider.                     
                      t                                                 
                          Model Letter Notifying Provider of Results of 
                           Revisit.                                     
                          Model Letter to Provider (Imposition of       
                           Remedies).                                   
                          (Immediate Jeopardy Exists).                  
                          Informal Dispute Resolution.                  
------------------------------------------------------------------------
                         Regional Office Manual                         
                      Standards and Certification                       
                            (HCFA Pub. 23-4)                            
              (Superintendent of Documents No. HE 22.8/8-3)             
------------------------------------------------------------------------
63                <bulle  OPO Designation Procedures in Service Areas   
                      t    With Competing Applications.                 
------------------------------------------------------------------------
                            Hospital Manual                             
                             (HCFA Pub. 10)                             
               (Superintendent of Documents No. HE 22.8/2)              
------------------------------------------------------------------------
712               <bulle  Self-Administered Drugs and Biologicals.      
                      t                                                 
                          Oral Cancer Drugs.                            
                          Self-Administered Antiemetic Drugs.           
                          Self-Administered Drug Administered In An     
                           Emergency Situation.                         
                          Billing for Hospital Outpatient Partial       
                           Hospitalization Services.                    
                          Completion of Form HCFA-1450 For Inpatient And/
                           Or Outpatient Billing.                       
713               <bulle  Review of Hospital Admissions of Patients Who 
                      t    Have Elected Hospice Care.                   
714               <bulle  Outpatient Therapeutic Services.              
                      t                                                 
715               <bulle  Laboratory Test for Hemodialysis, Intermittent
                      t    Peritoneal Dialysis, and Continuous Cycling  
                           Peritoneal Dialysis Included in Composite    
                           Rate.                                        
------------------------------------------------------------------------
                Rural Health Clinic Manual and Federally                
                    Qualified Health Centers Manual                     
                             (HCFA Pub. 27)                             
            (Superintendent of Documents No. HE 22.8/19:985)            
------------------------------------------------------------------------
25                <bulle  Rural Health Clinics.                         
                      t                                                 
                          Federally Qualified Health Centers.           
26                <bulle  Billing of Pneumococcal Pneumonia, Influenza  
                      t    Virus and Hepatitis B Vaccines By Rural      
                           Health Clinics and Federally Qualified Health
                           Centers.                                     
------------------------------------------------------------------------
                     Renal Dialysis Facility Manual                     
                        (Non-Hospital Operated)                         
                             (HCFA Pub. 29)                             
              (Superintendent of Documents No. HE 22.8/13)              
------------------------------------------------------------------------
78                <bulle  Pneumoccal Pneumonia, Influenza Virus, and    
                      t    Hepatitis B Vaccines.                        
79                <bulle  Completion of Form HCFA-1450 by Independent   
                      t    Facilities for Home Dialysis Items and       
                           Services Billed Under the Composite Rate     
                           (Method I).                                  
80                <bulle  Epoetin.                                      
                      t                                                 

[[Page 62330]]

                                                                        
81                <bulle  Laboratory Test for Hemodialysis, Intermittent
                      t    Peritoneal Dialysis, and Continuous Cycling  
                           Peritoneal Dialysis.                         
------------------------------------------------------------------------
                         Coverage Issues Manual                         
                             (HCFA Pub. 6)                              
              (Superintendent of Documents No. HE 22.8/14)              
------------------------------------------------------------------------
94                <bulle  Artificial Hearts and Related Devices.        
                      t                                                 
95                <bulle  Electrostimulation in the Treatment of Wounds.
                      t                                                 
                          Intrapulmonary Percussive Ventilator.         
96                <bulle  Breast Reconstruction Following Mastectomy    
                      t    Obsolete or Unreliable Diagnostic Test.      
97                <bulle  Urinary Drainage Bags.                        
                      t                                                 
98                <bulle  -Electrostimulation in the Treatment of Wounds
                      t    Intrapulmonary Percussive Ventilator.        
99                <bulle  Laser Procedures.                             
                      t                                                 
                          Refractive Keratoplasty.                      
                          Magnetic Resonance Angiography.               
100               <bulle  Electrostimulation in the Treatment of Wounds.
                      t                                                 
                          Intrapulmonary Percussive Ventilator.         
101               <bulle  Laboratory Test-CRD Patients.                 
                      t                                                 
------------------------------------------------------------------------
                     Provider Reimbursement Manual                      
                        Part 1--(HCFA Pub.15-1)                         
              (Superintendent of Documents No. HE 22.8/4)               
------------------------------------------------------------------------
399               <bulle  Regional Medicare Swing-Bed SNF Rates.        
                      t                                                 
                          Changing Cost Finding Methods.                
                          Changing Bases for Allocating Costs Centers or
                           Order in Which Cost Centers Are Allocated.   
------------------------------------------------------------------------
                     Provider Reimbursement Manual                      
                       Part 1--(HCFA Pub.15-1-27)                       
              (Superintendent of Documents No. HE 22.8/4)               
------------------------------------------------------------------------
27                <bulle  Separately Billable ESRD Laboratory Services. 
                      t                                                 
28                <bulle  Epoetin.                                      
                      t                                                 
------------------------------------------------------------------------
                     Provider Reimbursement Manual                      
Part II--Provider Cost Reporting Forms and Instructions (HCFA Pub. 15-II-
                                   AF)                                  
              (Superintendent of Documents No. HE 22.8/4)               
------------------------------------------------------------------------
5                 <bulle  Electronic Reporting Specifications for Form  
                      t    HCFA 1728-94.                                
------------------------------------------------------------------------
                 Medicare Provider Reimbursement Manual                 
Part II--Provider Cost Reporting Forms and Instructions (HCFA Pub. 15-11-
                                  AI)                                   
              (Superintendent of Documents No. HE 22. 8/4)              
------------------------------------------------------------------------
2                 <bulle  Cost Center Coding.                           
                      t                                                 
                          Electronic Reporting Specifications for Form  
                           HCFA 2540-96.                                
------------------------------------------------------------------------
                           Medicare/Medicaid                            
                     Sanction--Reinstatement Report                     
                             (HCFA Pub. 69)                             
------------------------------------------------------------------------
97-5              <bulle  Report of Physicians/Practitioners, Providers 
                      t    and/or Other Health Care Suppliers Excluded/ 
                           Reinstated--March 1997.                      
97-6              <bulle  Report of Physicians/Practitioners, Providers 
                      t    and/or Other Health Care Suppliers Excluded/ 
                           Reinstated--April 1997.                      
------------------------------------------------------------------------


                                           Addendum IV--Regulation Documents Published in the Federal Register                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                   End of               
     Publication date        FR Vol. 62 page          CFR part(s)                 File code*              Regulation title        comment     Effective 
                                                                                                                                   period        date   
--------------------------------------------------------------------------------------------------------------------------------------------------------
04/08/97..................       16894-16976  144, 146, 148.............  BPD-890-IFC                Interim Rules for Health      07/07/97     06/07/97
                                                                                                      Insurance Portability                             
                                                                                                      for Group Health Plans.                           
04/08/97..................       16985-17004  148.......................  BPD-882-IFC                Individual Market Health      07/07/97     04/08/97
                                                                                                      Insurance Reform:                                 
                                                                                                      Portability From Group                            
                                                                                                      to Individual Coverage;                           
                                                                                                      Federal Rules for Access                          
                                                                                                      in the Individual                                 
                                                                                                      Market; State                                     
                                                                                                      Alternative Mechanisms                            
                                                                                                      to Federal Rules.                                 

[[Page 62331]]

                                                                                                                                                        
04/08/97..................             17004  ..........................  BPD-882-CN                 Interim Rules for Health   ...........     04/08/97
                                                                          BPD-890-CN                  Insurance Portability                             
                                                                                                      for Group Health Plans                            
                                                                                                      and Individual Market                             
                                                                                                      Health Insurance Reform:                          
                                                                                                      Portability from Group                            
                                                                                                      to Individual Coverage;                           
                                                                                                      and Federal Rules for                             
                                                                                                      Access in the Individual                          
                                                                                                      Market; State                                     
                                                                                                      Alternative Mechanisms                            
                                                                                                      to Federal Rules;                                 
                                                                                                      Correction.                                       
04/17/97..................       18776-18777  ..........................  ORD-098-N                  New and Pending            ...........  ...........
                                                                                                      Demonstration Project                             
                                                                                                      Proposals Submitted                               
                                                                                                      Pursuant to Section                               
                                                                                                      1115(a) of the Social                             
                                                                                                      Security Act: February                            
                                                                                                      1997.                                             
04/21/97..................       19326-19328  ..........................  BPD-894-NC                 Medicare and Medicaid         06/20/97  ...........
                                                                                                      Programs; Announcement                            
                                                                                                      of Additional                                     
                                                                                                      Applications From                                 
                                                                                                      Hospitals Requesting                              
                                                                                                      Waivers for Organ                                 
                                                                                                      Procurement Service Area.                         
04/21/97..................       19328-19337  ..........................  BPO-141-N                  Medicare and Medicaid      ...........  ...........
                                                                                                      Programs; Quarterly                               
                                                                                                      Listing of Program                                
                                                                                                      Issuances--Third Quarter                          
                                                                                                      1996.                                             
04/28/97..................             22995  413.......................  BPD-808-P                  Medicare and Medicaid      ...........  ...........
                                                                                                      Programs; Salary                                  
                                                                                                      Equivalency Guidelines                            
                                                                                                      for Physical Therapy,                             
                                                                                                      Respiratory Therapy,                              
                                                                                                      Speech Language                                   
                                                                                                      Pathology, and                                    
                                                                                                      Occupational Therapy                              
                                                                                                      Services; Correction.                             
04/29/97..................       23251-23253  ..........................  HSQ-232-N                  Medicare Program;          ...........     10/28/96
                                                                                                      Initiative Involving                              
                                                                                                      Facilities That Furnish                           
                                                                                                      Hemodialysis Treatments.                          
04/29/97..................             23140  433.......................  MB-112-F                   Medicaid Program; Third    ...........     09/08/95
                                                                                                      Party Liability (TPL)                             
                                                                                                      Cost-Effectiveness                                
                                                                                                      Waivers; Correcting                               
                                                                                                      Amendment.                                        
04/30/97..................       23368-23376  417.......................  OMC-025-FC                 Medicare Program;             06/30/97     06/30/97
                                                                                                      Establishment of an                               
                                                                                                      Expedited Review Process                          
                                                                                                      for Medicare                                      
                                                                                                      Beneficiaries Enrolled                            
                                                                                                      in Health Maintenance                             
                                                                                                      Organizations,                                    
                                                                                                      Competitive Medical                               
                                                                                                      Plans, and Health Care                            
                                                                                                      Prepayment Plans.                                 
05/05/97..................       24483-24491  ..........................  BPD-816-N                  Medicare Program; Update   ...........     05/05/97
                                                                                                      of the Reasonable                                 
                                                                                                      Compensation Equivalent                           
                                                                                                      Limits for Services                               
                                                                                                      Furnished by Physicians.                          
05/12/97..................       25844-25855  405, 417, 473.............  BPD-453-FC                 Medicare Programs;            07/11/97     07/11/97
                                                                                                      Medicare Appeals of                               
                                                                                                      Individual Claims.                                
05/12/97..................       25855-25858  493.......................  HSQ-237-FC                 Medicare, Medicaid and        07/11/97     05/12/97
                                                                                                      CLIA Programs; Clinical                           
                                                                                                      Laboratory Requirements--                         
                                                                                                       Extension of Certain                             
                                                                                                      Effective Dates for                               
                                                                                                      Clinical Laboratory                               
                                                                                                      Requirements Under CLIA.                          
05/12/97..................             25957  ..........................  ORD-099-N                  New and Pending            ...........  ...........
                                                                                                      Demonstration Project                             
                                                                                                      Proposals Submitted                               
                                                                                                      Pursuant to Section                               
                                                                                                      1115(a) of the Social                             
                                                                                                      Security Act: March 1997.                         
05/12/97..................       25957-25964  ..........................  BPO-148-N                  Medicare and Medicaid      ...........  ...........
                                                                                                      Programs; Quarterly                               
                                                                                                      Listing of Program                                
                                                                                                      Issuances; Fourth                                 
                                                                                                      Quarter 1996.                                     
05/14/97..................       26545-26550  ..........................  MB-103-NC                  Medicaid Program;             06/13/97     05/14/97
                                                                                                      Allocation of Enhanced                            
                                                                                                      Federal Matching Funds                            
                                                                                                      for Increased                                     
                                                                                                      Administrative Costs                              
                                                                                                      Resulting From Welfare                            
                                                                                                      Reform.                                           
05/19/97..................       27262-27265  ..........................  HSQ-242-N                  Approval of the            ...........    05/19/97-
                                                                                                      Commission on Office                       11/1/97
                                                                                                      Laboratory Accreditation                          
                                                                                                      for Immunohematology.                             
05/19/97..................             27210  413.......................  BPD-788-CN                 Medicare Program;          ...........     05/19/97
                                                                                                      Electronic Cost                                   
                                                                                                      Reporting for Skilled                             
                                                                                                      Nursing Facilities and                            
                                                                                                      Home Health Agencies;                             
                                                                                                      Correction.                                       
05/30/97..................       29355-29356  ..........................  OPL-015-N                  Medicare Program; June     ...........  ...........
                                                                                                      16, 1997, Meeting of the                          
                                                                                                      Practicing Physicians                             
                                                                                                      Advisory Council.                                 

[[Page 62332]]

                                                                                                                                                        
06/02/97..................       29902-30037  412, 413, 489.............  BPD-878-P                  Medicare Program; Changes     08/01/97  ...........
                                                                                                      to the Hospital                                   
                                                                                                      Inpatient Prospective                             
                                                                                                      Payment Systems and                               
                                                                                                      Fiscal Year 1998 Rates.                           
06/04/97..................       30604-30605  ..........................  ORD-100-N                  New and Pending            ...........  ...........
                                                                                                      Demonstration Project                             
                                                                                                      Proposals Submitted                               
                                                                                                      Pursuant to Section                               
                                                                                                      1115(a) of the Social                             
                                                                                                      Security Act: April 1997.                         
06/10/97..................       31669-31670  144, 146..................  BPD-890-CN                 Interim Rules for Health   ...........  ...........
                                                                                                      Insurance Portability                             
                                                                                                      for Group Health Plans;                           
                                                                                                      Correction.                                       
06/17/97..................       32715-32733  410, 424..................  BPD-813-P                  Medicare Program;             08/18/97  ...........
                                                                                                      Ambulance Services.                               
06/18/97..................       33158-33305  400, 405, 410, 414........  BPD-884-P                  Medicare Program;             08/18/97  ...........
                                                                                                      Revisions to Payment                              
                                                                                                      Policies Under the                                
                                                                                                      Physician Fee Schedule,                           
                                                                                                      Other Part B Payment                              
                                                                                                      Policies, and                                     
                                                                                                      Establishment of the                              
                                                                                                      Clinical Psychologist                             
                                                                                                      Fee Schedule for                                  
                                                                                                      Calendar Year 1998.                               
06/19/97..................             33459  ..........................  MB-103-NC                  Medicaid Program;          ...........  ...........
                                                                                                      Allocation of Enhanced                            
                                                                                                      Federal Matching Funds                            
                                                                                                      for Increased                                     
                                                                                                      Administrative Costs                              
                                                                                                      Resulting From Welfare                            
                                                                                                      Reform; Correction.                               
--------------------------------------------------------------------------------------------------------------------------------------------------------

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. Also, 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. To obtain more information 
about the classes or categories, please refer to the Federal Register 
notice published on April 21, 1997 (62 FR 19328).
    The following information presents the device number, category (in 
this case, A), and criterion code.

G960260  A1
G970007  A2
G970015  A2
G970018  A2
G970022  A2
G970068  A2
G970069  A2
G970076  A2
G970093  A2
G970121  A2

    The following information presents the device number, category (in 
this case, B), and criterion code.

G960033  B4
G960209  B4
G960222  B2
G960233  B4
G960240  B5
G960261  B2
G970033  B4
G970043  B4
G970049  B3
G970060  B3
G970062  B1
G970063  B4
G970064  B2
G970065  B3
G970066  B4
G970067  B2
G970072  B2
G970077  B1
G970079  B2
G970080  B4
G970083  B4
G970085  B2
G970090  B4
G970091  B3
G970092  B2
G970098  B4
G970104  B2
G970105  B2
G970108  B1
G970109  B3
G970113  B4
G970115  B4
G970117  B4

[FR Doc. 97-30568 Filed 11-20-97; 8:45 am]
BILLING CODE 4120-01-P