[Federal Register Volume 61, Number 68 (Monday, April 8, 1996)]
[Notices]
[Pages 15491-15504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8623]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-136-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances and Coverage Decisions; Third Quarter 1995

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 July, August, and 
September of 1995 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 timeframe. We are also 
providing the content of revisions to the Medicare Coverage Issues 
Manual published during the period July 1 through September 30, 1995. 
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).
Nancy Ranels, (410) 786-8928 (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 authority granted the Secretary under 
sections 1102, 1871, and 1902 and related provisions of the Social 
Security Act (the Act) and also issue various manuals, memoranda, and 
statements necessary to administer the programs efficiently.
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, statements of policy, and guidelines 
of general applicability not issued as regulations. We published our 
first notice June 9, 1988 (53 FR 21730). Although we are not mandated 
to do so by statute, for the sake of completeness of the listing of 
operational and policy statements, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the 3-month timeframe. Since the 
publication of our quarterly listing on June 12, 1992 (57 FR 24797), we 
decided to add Medicaid issuances to our quarterly listings. 
Accordingly, we list in this notice Medicaid issuances and Medicaid 
substantive and interpretive regulations published during July 1 
through September 1995.

II. Medicare Coverage Issues

    We receive numerous inquiries from the general public about whether 
specific items or services are covered under Medicare. Providers, 
carriers, and intermediaries have copies of the Medicare Coverage 
Issues Manual, which identifies those medical items, services, 
technologies, or treatment procedures that can be paid for under 
Medicare.
    On August 21, 1989, we published a notice in the Federal Register 
(54 FR 34555) that contained all the Medicare coverage decisions issued 
in that manual.
    In that notice, we indicated that revisions to the Coverage Issues 
Manual will be published at least quarterly in the Federal Register. We 
also sometimes issue proposed or final national coverage decision 
changes in separate

[[Page 15492]]
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 
timeframe to determine whether any are of particular interest. We 
expect it to be used in concert with previously published notices. Most 
notably, those unfamiliar with a description of our Medicare manuals 
may wish to review Table I of our first three notices (53 FR 21730, 53 
FR 36891, and 53 FR 50577) and the notice published March 31, 1993 (58 
FR 16837), and those desiring information on the Medicare Coverage 
Issues Manual may wish to review the August 21, 1989, publication (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 September 30, 
1995. 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 title of 
the regulation, the parts of the Code of Federal Regulations (CFR) that 
have changed (if applicable), the agency file code number, 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 the initial 
list of all of the Food and Drug Administration-approved 
investigational device exemption numbers organized by 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 include the additions and deletions to this initial 
list of devices with a Food and Drug Administration-approved 
investigational device exemption.

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, PO 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.

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.
    
[[Page 15493]]

     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, 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 ``Electronic Data Interchange Enrollment Form,'' 
use the Superintendent of Documents No. HE 22.8/7 and the HCFA 
transmittal number 1519.

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 
Nancy Ranels, Bureau of Policy Development, Office of Regulations, 
Health Care Financing Administration, C5-09-05, 7500 Security Blvd., 
Baltimore, MD 21244-1850, Telephone (410) 786-8928.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)

    Dated: March 29, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.

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)

Addendum II--Description of Manuals, Memoranda, and HCFA Rulings

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

  Addendum III.--Medicare and Medicaid Manual Instructions July Through 
                             September 1995                             
------------------------------------------------------------------------
     Trans. No.                 Manual/subject/publication No.          
------------------------------------------------------------------------
       Intermediary Manual Part 3--Claims Process (HCFA-Pub. 13-3)      
             (Superintendent of Documents No. HE 22.8/6-1)              
                                                                        
------------------------------------------------------------------------
1655                   Electronic Data Interchange Enrollment   
                       Form HCFA-486.                                   
1656                   Medical Update and Patient Information.  
1657                   Medicare Part A Standard Paper Remittance
                       Advice.                                          
1658                   Reporting Outpatient Surgery and Other   
                       Services.                                        
1659                   Claims Processing Terminology.           
                      Handling Incomplete or Invalid Claims.            
                      Data Element Requirements Matrix.                 
                      Addendum L, Data Element Requirements Matrix.     
                  16   Provider Electronic Billing File and     
                   6   Record Formats.                                  
                   0                                                    
                      Alphabetic Listing of Data Elements.              
                      Patient Information Data Definitions and Codes.   
                      Forms HCFA-700/701, Outpatient Rehabilitative     
                       Services Forms.                                  
                      Electronic Formats for Medical Review Attachment  
                       Information.                                     

[[Page 15494]]
                                                                        
                      Electronic Media Claims Flat File Record for      
                       Outpatient Rehabilitation Services--Record Type  
                       77.                                              
                      Flat File Requirements for Record Type 77,        
                       Outpatient Rehabilitation Services.              
                      Requirements by Record Type and Field (Data       
                       Element) for Outpatient Rehabilitative Services. 
                      Definition of Narrative Type Indicators.          
                      Validating Information and Returning Submissions  
                       Independent of Claim.                            
1661                   HCPCS for Hospital Outpatient Radiology  
                       Services and Other Diagnostic Procedures.        
                      Radiology HCPCS Codes Subject to the Payment      
                       Limit.                                           
                      Other Diagnostic Services HCPCS Codes Subject to  
                       the Payment Limit.                               
                                                                        
------------------------------------------------------------------------
         Carriers Manual--Part 3, Claims Process (HCFA-Pub. 14-3)       
               (Superintendent of Documents No. HE 22.8/7)              
                                                                        
------------------------------------------------------------------------
1519                   Electronic Data Interchange Enrollment   
                       Form.                                            
1520                   Nurse Practitioner Services, Clinical    
                       Nurse Specialist Services.                       
1521                   Part B Provider Access to Limited        
                       Eligibility Data.                                
                      Eligibility Data Available.                       
                      Contractor Implementation.                        
                      HCFA Standard Part B Eligibility Inquiry Flat File
                       Specifications.                                  
                      HCFA Standard Part B Eligibility Response Flat    
                       File Specifications.                             
1522                   Nonparticipating Physicians to Provide   
                       Notices For Elective Surgery.                    
1523                   Services Received by Medicare            
                       Beneficiaries Outside the United States.         
1524                   Drugs and Biologicals.                   
1525                   Local MR Policy.                         
                      Internal MR Guidelines.                           
                      The Carrier Advisory Committee.                   
                      Data Analysis to Identify Aberrancies.            
                      Medical Review Prepayment Screens.                
                      Categories of MR Screens.                         
                      HCFA Mandated and HCFA Optional MN Screens.       
                      Assessing an Overpayment When the CMR Was Based on
                       a SVRS.                                          
                      The Carrier Medical Director and Carrier          
                       Coordination.                                    
                      Carrier Coordination With Peer Review             
                       Organization.                                    
                      Medicare FMR Status Report.                       
                      Medical Review.                                   
                      Coordination With Carrier Medicare Fraud Unit.    
                      National Coverage Policy.                         
                      Local MR Policy.                                  
                      Internal MR Guidelines.                           
                      Utilization Guidelines and Parameters.            
                      The Carrier Advisory Committee.                   
                      Data Analysis.                                    
                      Data Analysis to Identify Aberrancies.            
                      Aberrancies.                                      
                      Taking Corrective Actions on Identified           
                       Aberrancies.                                     
                      Conducting Evaluation of Effectiveness of         
                       Corrective Action.                               
                      Standard Postpayment Data Reports.                
                      Evaluation of MR Prepayment Screens.              
                      MR Screen Parameters.                             
                      HCFA Mandated and HCFA Optional MN Screens.       
                      Postpayment MR.                                   
                      Postpayment Review Personnel.                     
                      CMR Corrective Actions.                           
                      Assessing an Overpayment or Potential Overpayment 
                       When the CMR Was Based on a Limited Sample/      
                       Subsample.                                       
                      MN Denials.                                       
                      Carrier Coordination with Fiscal Intermediary.    
1526                   Claims Processing Terminology.           
                      Handling Incomplete or Invalid Claims.            
                      Data Element Requirements Matrix.                 
                      Conditional Data Element Requirements.            
                      Data Element Requirements Matrix.                 
                                                                        
------------------------------------------------------------------------
  Program Memorandum, Intermediaries (HCFA-Pub. 60A) (Superintendent of 
                        Documents No. HE 22.8/7)                        
                                                                        
------------------------------------------------------------------------
A-95-9                 Star Alert.                              
                                                                        
------------------------------------------------------------------------
     Program Memorandum, Carriers (HCFA-Pub. 60B) (Superintendent of    
                       Documents No. HE 22.8/6-5)                       
                                                                        
------------------------------------------------------------------------
B-95-5                 Implementation of Limitation on          
                       Information Provided by Suppliers on Certificates
                       of Medical Necessity (Sec.  1834 of the Act, as  
                       amended by Sec.  131 of the Social Security Act  
                       Amendments of 1994).                             
                                                                        
------------------------------------------------------------------------
 
[[Page 15495]]
                                                                        
      Program Memorandum, Intermediaries/Carriers (HCFA-Pub. 60AB)      
              (Superintendent of Documents No. HE 22.8/6-5)             
                                                                        
------------------------------------------------------------------------
AB-95-7                Current Status of Medicare Program       
                       Memorandums and Letters Issued Before Calendar   
                       Year (CY) 1995.                                  
AB-95-8                New Interest Rate Payable on Clean Claims
                       Not Paid Timely.                                 
AB-95-9                Changes in MSP Demand Process.           
AB-95-10               Changes in MSP Demand Process (This PM   
                       was reissued to correct a typographical error.)  
                                                                        
------------------------------------------------------------------------
        Program Memorandum, Medicaid State Agencies (HCFA-Pub. 17)      
              (Superintendent of Documents No. HE 22.8/6-5)             
                                                                        
------------------------------------------------------------------------
95-5                   Current Status of Medicaid PMs and Action
                       Transmittals Issued Before Calendar Year (CY)    
                       1995.                                            
95-6                   Application of the Nursing Home          
                       Enforcement Regulations to Life Safety Code      
                       Surveys.                                         
                                                                        
------------------------------------------------------------------------
 Hospital Manual (HCFA-Pub 10) (Superintendent of Documents No. HE 22.8/
                                   2)                                   
                                                                        
------------------------------------------------------------------------
683                    Reporting Outpatient Surgery and Other   
                       Services.                                        
684                    HCPCS for Hospital Outpatient Radiology  
                       and Other Diagnostic Procedures.                 
                      Radiology HCPCS Codes Subject to the Payment      
                       Limit.                                           
                      Other Diagnostic Services HCPCS Codes Subject to  
                       the Payment Limit.                               
                                                                        
------------------------------------------------------------------------
  Home Health Agency Manual (HCFA-Pub. 11) (Superintendent of Documents 
                             No. HE 22.8/5)                             
                                                                        
------------------------------------------------------------------------
276                    HCFA-486--Medical Update and Patient     
                       Information.                                     
                                                                        
------------------------------------------------------------------------
    Skilled Nursing Facility Manual (HCFA-Pub. 12) (Superintendent of   
                        Documents No. HE 22.8/3)                        
                                                                        
------------------------------------------------------------------------
339                    Special Billing Instructions for         
                       Pneumococcal Pneumonia, Influenza Virus and      
                       Hepatitis B Vaccines.                            
                                                                        
------------------------------------------------------------------------
  Health Maintenance Organization/Competitive Medical Plan Manual (HCFA-
        Pub. 75) (Superintendent of Documents No. HE 22/8/21:989)       
                                                                        
------------------------------------------------------------------------
15                     Risk Payment.                            
                      Annual Reconciliation.                            
                      Benefit Stabilization Fund Withholds/Withdrawals. 
                      Electronic Transfer of Funds.                     
                      Plan Payment Report.                              
                      Monthly Payment Letter.                           
                      Adjustments to County Level.                      
                      Conversion of County Per Capita Costs Into Rates  
                       Example of AAPCC Methodology.                    
                      Definitions.                                      
                      Form of Additional Benefits.                      
                      Report on Value of Additional and Supplemental    
                       Benefits.                                        
                                                                        
------------------------------------------------------------------------
  Coverage Issues Manual (HCFA-Pub. 6) (Superintendent of Documents No. 
                               HE 22.8/14)                              
                                                                        
------------------------------------------------------------------------
78                     Assessing Patient's Suitability for      
                       Electrical Nerve Stimulation Therapy.            
                      Transcutaneous Electrical Nerve Stimulation for   
                       Acute Post-Operative Pain.                       
                      Supplies Used in the Delivery of Transcutaneous   
                       Electrical Nerve Stimulation and Neuromuscular   
                       Electrical Stimulation.                          
                      Electrical Nerve Stipulators.                     
79                     Transcendental Meditation.               
                                                                        
------------------------------------------------------------------------
   Regional Office Manual Standards and Certification (HCFA-Pub. 23-4)  
              (Superintendent of Documents No. HE 22.8/8-3)             
                                                                        
------------------------------------------------------------------------
60                     Request for Survey of Sections 489.20 and
                       489.24 Essentials of Provider Agreement:         
                       Responsibilities of Medicare Participating       
                       Hospitals in Emergency Cases.                    
                      Model Letter Acknowledging Complaint Alleging     
                       Noncompliance With 42 CFR 489.24 and/or the      
                       Related Requirements of 42 CFR 489.20:           
                       Investigation Not Warranted.                     
                      Model Letter Acknowledging Complaint Alleging     
                       Noncompliance With 42 CFR 489.24 and/or the      
                       Related Requirements of 42 CFR 489.20:           
                       Investigation Warranted.                         
                      Responsibilities of Medicare Participating        
                       Hospitals in Emergency Cases Investigation       
                       Report.                                          
61                     Special Procedures for End Stage Renal   
                       Disease Facilities.                              
                      Special Procedures for Laboratories.              
                      Program Background and Responsibilities.          
                      Validation and Complaint Surveys of CLIA-Exempt   
                       Laboratories.                                    
                      Adverse Actions.                                  
                      Appeals of Adverse Actions.                       
                      Special Procedures for Accredited Laboratories.   
                      CLIA Fee Collection Procedures.                   

[[Page 15496]]
                                                                        
                      Federal Surveys.                                  
                                                                        
------------------------------------------------------------------------
       Budget and Administration, State Operations Manual, Provider     
Certification (HCFA-Pub. 7) (Superintendent of Documents No. HE 22.8/12)
                                                                        
------------------------------------------------------------------------
275                    Approval Process.                        
                      Resident Assessment Instrument for Long Term Care 
                       Facilities.                                      
276                    Requirements for Specialty Hospitals.    
                      Interpretive Guidelines--Psychiatric Hospitals.   
                      Medicare/Medicaid Psychiatric Hospital Survey Data
                       (HCFA-724).                                      
                      Surveyor Worksheet for Psychiatric Hospital Review
                       (HCFA-725).                                      
                      HCFA Death Record Review Data Sheet (HCFA-726).   
                      HCFA Nursing Complement Data (HCFA-727).          
                      HCFA Total Nursing Staff Data (HCFA-728).         
                      Data Collection Medical Staff Coverage (HCFA-729).
                                                                        
------------------------------------------------------------------------
    Peer Review Organization Manual (HCFA-Pub. 19) (Superintendent of   
                        Documents No. HE 8/8-15)                        
                                                                        
------------------------------------------------------------------------
52                     Commonly Used Acronyms.                  
                        Background and Authority.                       
                        Hospital Requirements.                          
                        Hospital Penalties for Noncompliance.           
                        RO Responsibilities.                            
                        State Agency Surveys.                           
                        PRO Review Responsibilities.                    
                        Physician Review Outline.                       
                        60-Day PRO Review: Opportunity for Discussion.  
53                     Glossary.                                
                                                                        
------------------------------------------------------------------------
 Provider Reimbursement Manual, Part 1 (HCFA-Pub. 15-1), (Superintendent
                       of Documents No. HE 22.8/4)                      
                                                                        
------------------------------------------------------------------------
385                    Reasonable Costs.                        
                      Factors To Be Considered in Determining Reasonable
                       Cost of Purchased Management and Administrative  
                       Support Services.                                
                      Insurance Purchased From a Limited Purpose        
                       Insurance Company.                               
                      Legal Fees and Other Related Costs.               
                                                                        
------------------------------------------------------------------------
  Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms 
   and Instructions--Chapter 28 (HCFA-Pub. 15-IIAB) (Superintendent of  
                        Documents No. HE 22.8/4)                        
                                                                        
------------------------------------------------------------------------
7                      Electronic Reporting Specifications for  
                       Form-2552-92.                                    
                                                                        
------------------------------------------------------------------------
  Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms 
   and Instructions--Chapter 31 (HCFA-Pub. 15-IIAE) (Superintendent of  
                        Documents No. HE 22.8/4)                        
                                                                        
------------------------------------------------------------------------
3                      This transmittal makes corrections to    
                       Chapter 31.                                      
                                                                        
------------------------------------------------------------------------
  Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms 
  and Instructions--Chapter 34--(HCFA-Pub. 15-IIAH) (Superintendent of  
                        Documents No. HE 22.8/4)                        
                                                                        
------------------------------------------------------------------------
3                      Worksheet S-1--Independent Renal Dialysis
                       Facility Statistical Data.                       
                      Worksheet A--Reclassification and Adjustment of   
                       Trial Balance of Expenses.                       
                      Worksheet A-2--Adjustment of Expenses.            
                                                                        
------------------------------------------------------------------------
   End Stage Renal Disease Network, Organizations Manual (HCFA-Pub. 81) 
               (Superintendent of Documents No. 22.8.9/4)               
                                                                        
------------------------------------------------------------------------
4                      Introduction.                            
                      Objectives.                                       
                      Network Role.                                     
                      Community Outreach Plan.                          
                      Clearinghouse Activities.                         
                      Patient Grievances.                               
                      Origin of Patient Grievances.                     
                      Scope of Grievances.                              
                      Role of Network in Resolution of Patient          
                       Grievances.                                      
                      Determining Grievances for Network Involvement.   
                      Patient Awareness of Process.                     
                      Use of Facility Grievance Process.                

[[Page 15497]]
                                                                        
                      Determination of Network Involvement.             
                      Life-threatening Situations.                      
                      Patient Representative.                           
                      Requirement of Grievance in Writing.              
                      Timing of Network Activity.                       
                      Written Acknowledgment of Grievance.              
                      Conclusion of Investigation.                      
                      Exception.                                        
                      Nature of Response and Potential Outcomes.        
                      Contents of Report to Patient.                    
                      Use of ROs.                                       
                      Potential Outcomes of Patient Grievance Process.  
                      Improvement Plans.                                
                      Content of Improvement Plans.                     
                      Time period for Review, Acceptance/Rejection of   
                       Improvement Plans.                               
                      Information that May be Disclosed.                
                      Identity of Patient.                              
                      Facility Identity.                                
                      Conflict of Interest.                             
                      States in Each Region.                            
                                                                        
------------------------------------------------------------------------
         State Medicaid Manual, Part 4--Services (HCFA-Pub. 45-4)       
                (Superintendent of Documents No. 22.8/10)               
                                                                        
------------------------------------------------------------------------
68                     Nurse Practitioner Services.             
                                                                        
------------------------------------------------------------------------
            Medicare/Medicaid, Sanction--Reinstatement Report           
                                                                        
------------------------------------------------------------------------
95-8                   Report of Physicians/Practitioners,      
                       Providers and/or Other Health Care Suppliers     
                       Excluded/Reinstated--May 1995.                   
95-9                   Report of Physicians/Practitioners,      
                       Providers and/or Other Health Care Suppliers     
                       Excluded/Reinstated--June 1995.                  
95-10                  Report of Physicians/Practitioners,      
                       Providers and/or Other Health Care Suppliers     
                       Excluded/Reinstated--July 1995.                  
------------------------------------------------------------------------



Addendum IV--Medicare Coverage Issues Manual

    (For the reader's convenience, new material and changes to 
previously published material are in italics. If any part of a sentence 
in the manual instruction has changed, the entire line is shown in 
italics. The transmittal includes material unrelated to revised 
sections. In this addendum we do not reprint the unrelated material.) 
Transmittal No. 78; sections 35-46 (Cont.)--35-48; sections 45-16-45-
25; sections 60-19--60-20; sections 65-7--65-9
CHANGED IMPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: For Services 
Furnished On or After 08/07/95.
    Section 35-46, Assessing Patient's Suitability for Electrical Nerve 
Stimulation Therapy, Section 45-19, Transcutaneous Electrical Nerve 
Stimulation (TENS) for Acute Post-Operative Pain, Section 45-25, 
Supplies Used in the Delivery of Transcutaneous Electrical Nerve 
Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES), and 
Section 65-8, Electrical Nerve Stimulators, are revised to reflect that 
TENS are no longer covered under the prosthetic device benefit. HCFA 
has determined that they meet the definition of the durable medical 
equipment benefit rather than the prosthetic device benefit.
NEW IMPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: For Services Furnished 
On or After 08/07/95.
    Section 60-20, Transcutaneous electrical Nerve Stimulators (TENS), 
indicates that TENS are covered under the durable medical equipment 
benefit. HCFA has determined that TENS meets the definition of the 
durable medical equipment benefit rather than the prosthetic device 
benefit. These coverage guidelines had appeared in Sec. 65-8 when TENS 
were covered under the prosthetic device benefit.
DISCLAIMER
    The revision date and transmittal number only apply to the redlined 
material. All other material was previously published in the manual and 
is only being reprinted.
35-46  ASSESSING PATIENT'S SUITABILITY FOR ELECTRICAL NERVE STIMULATION 
THERAPY
    Electrical nerve stimulation is an accepted modality for assessing 
a patient's suitability for ongoing treatment with a transcutaneous or 
an implanted nerve stimulator. Accordingly, program payment may be made 
for the following techniques when used to determine the potential 
therapeutic usefulness of an electrical nerve stimulator:
    A. Transcutaneous Electrical Nerve Stimulation (TENS).--This 
technique involves attachment of a transcutaneous nerve stimulator to 
the surface of the skin over the peripheral nerve to be stimulated. It 
is used by the patient on a trial basis and its effectiveness in 
modulating pain is monitored by the physician or physical therapist. 
Generally, the physician or physical therapist is able to determine 
whether the patient is likely to derive a significant therapeutic 
benefit from continuous use of a transcutaneous stimulator within a 
trial period of 1 month; in a few cases this determination may take 
longer to make. Document the medical necessity for such services which 
are furnished beyond the first month. (See Sec. 45-25 for an 
explanation of coverage of medically necessary supplies for the 
effective use of TENS.)
    If TENS significantly alleviates pain, it may be considered as 
primary treatment; if it produces no relief or greater discomfort than 
the original

[[Page 15498]]
pain, electrical nerve stimulation therapy is ruled out. However, where 
TENS produces incomplete relief, further evaluation with percutaneous 
electrical nerve stimulation may be considered to determine whether an 
implanted peripheral nerve stimulator would provide significant relief 
from pain. (See Sec. 35-46B.)
    Usually, the physician or physical therapist providing the services 
will furnish the equipment necessary for assessment. Where the 
physician or physical therapist advises the patient to rent the TENS 
from a supplier during the trial period rather than supplying it 
himself, program payment may be made for rental of the TENS as well as 
for the services of the physician or physical therapist who is 
evaluating its use. However, the combined program payment which is made 
for the physician's or physical therapist's services and the rental of 
the stimulator from a supplier should not exceed the amount which would 
be payable for the total service, including the stimulator, furnished 
by the physician or physical therapist alone.
    B. Percutaneous Electrical Nerve Stimulation (PENS).--This 
diagnostic procedure which involves stimulation of peripheral nerves by 
a needle electrode inserted through the skin is performed only in a 
physician's office, clinic, or hospital outpatient department. 
Therefore, it is covered only when performed by a physician or incident 
to physician's service. If pain is effectively controlled by 
percutaneous stimulation, implantation of electrodes is warranted.
    As in the case of TENS (described in subsection A), generally the 
physician should be able to determine whether the patient is likely to 
derive a significant therapeutic benefit from continuing use of an 
implanted nerve stimulator within a trial period of 1 month. In a few 
cases, this determination may take longer to make. The medical 
necessity for such diagnostic services which are furnished beyond the 
first month must be documented.

    Note: Electrical nerve stimulators do not prevent pain but only 
alleviate pain as it occurs. A patient can be taught how to employ 
the stimulator, and once this is done, can use it safely and 
effectively without direct physician supervision. Consequently, it 
is inappropriate for a patient to visit his physician, physical 
therapist or an outpatient clinic on a continuing basis for 
treatment of pain with electrical nerve stimulation. Once it is 
determined that electrical nerve stimulation should be continued as 
therapy and the patient has been trained to use the stimulator, it 
is expected that a stimulator will be implanted or the patient will 
employ the TENS on a continual basis in his home. Electrical nerve 
stimulation treatments furnished by a physician in his office, by a 
physical therapist or outpatient clinic are excluded from coverage 
by section 1862(a)(1) of the law. (See secton 65-8 for an 
explanation of coverage of the therapeutic use of implanted 
peripheral nerve stimulators under the prosthetic devices benefit. 
See Sec. 60-20 for an explanation of coverage of the therapeutic use 
of TENS under the durable medical equipment benefit.)

45-19  TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR ACUTE 
POST-OPERATIVE PAIN
    The use of transcutaneous electrical nerve stimulation (TENS) for 
the relief of acute post-operative pain is covered under Medicare. TENS 
may be covered whether used as an adjunct to the use of drugs, or as an 
alternative to drugs, in the treatment of acute pain resulting from 
surgery.
    TENS devices, whether durable or disposable, may be used in 
furnishing this service. When used for the purpose of treating acute 
post-operative pain, TENS devices are considered supplies. As such they 
may be hospital supplies furnished inpatients covered under Part A, or 
supplies incident to a physician's service when furnished in connection 
with surgery done on an outpatient basis, and covered under Part B.
    It is expected that TENS, when used for acute post-operative pain, 
will be necessary for relatively short periods of time, usually 30 days 
or less. In cases when TENS is used for longer periods, contractors 
should attempt to ascertain whether TENS is no longer being used for 
acute pain but rather for chronic pain, in which case the TENS device 
may be covered as durable medical equipment as described in Sec. 60-20.
    Cross-refer: HCFA Pub. 13-3, Secs. 65-8, 3101.4, 3112.4, 3113; HCFA 
Pub. 14-3, Secs. 65-8, 2050.1, 2100; HCFA Pub. 10, Secs. 65-8, 210.4, 
230, 235.
45-25 SUPPLIES USED IN THE DELIVERY OF TRANSCUTANEOUS ELECTRICAL NERVE 
STIMULATION (TENS) AND NEUROMUSCULAR ELECTRICAL STIMULATION (NMES)--
(Effective for services rendered (i.e., items rented or purchased) on 
or after July 14, 1988.)
    Transcutaneous Electrical Nerve Stimulation (TENS) and/or 
Neuromuscular Electrical Stimulation (NMES) can ordinarily be delivered 
to patients through the use of conventional electrodes, adhesive tapes 
and lead wires. There may be times, however, where it might be 
medically necessary for certain patients receiving TENS or NMES 
treatment to use, as an alternative to conventional electrodes, 
adhesive tapes and lead wires, a form-fitting conductive garment (i.e., 
a garment with conductive fibers which are separated from the patients' 
skin by layers of fabric).
    A form-fitting conductive garment (and medically necessary related 
supplies) may be covered under the program only when:
    1. It has received permission or approval for marketing by the Food 
and Drug Administration;
    2. It has been prescribed by a physician for use in delivering 
covered TENS or NMES treatment; and
    3. One of the medical indications outlined below is met:
     The patient cannot manage without the conductive garment 
because there is such a large area or so many sites to be stimulated 
and the stimulation would have to be delivered so frequently that it is 
not feasible to use conventional electrodes, adhesive tapes and lead 
wires;
     The patient cannot manage without the conductive garment 
for the treatment of chronic intractable pain because the areas or 
sites to be stimulated are inaccessible with the use of conventional 
electrodes, adhesive tapes and lead wires;
     The patient has a documented medical condition such as 
skin problems that preclude the application of conventional electrodes, 
adhesive tapes and lead wires;
     The patient requires electrical stimulation beneath a cast 
either to treat disuse atrophy, where the nerve supply to the muscle is 
intact, or to treat chronic intractable pain; or
     The patient has a medical need for rehabilitation 
strengthening (pursuant to a written plan of rehabilitation) following 
an injury where the nerve supply to the muscle is intact.
    A conductive garment is not covered for use with a TENS device 
during the trial period specified in Sec. 35-46 unless:
    4. The patient has a documented skin problem prior to the start of 
the trial period; and
    5. The carrier's medical consultants are satisfied that use of such 
an item is medically necessary for the patient.
    (See conditions for coverage of the use of TENS in the diagnosis 
and treatment of chronic intractable pain in Secs. 35- 46 and 60-20 and 
the use of NMES in the treatment of disuse atrophy in Sec. 35-77.)

60-20  TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS (TENS)

    TENS is a type of electrical nerve stimulator that is employed to 
treat chronic intractable pain. This

[[Page 15499]]
stimulator is attached to the surface of the patient's skin over the 
peripheral nerve to be stimulated. It may be applied in a variety of 
settings (in the patient's home, a physician's office, or in an 
outpatient clinic). Payment for TENS may be made under the durable 
medical equipment benefit. (See Sec. 45-25 for an explanation of 
coverage of medically necessary supplies for the effective use of TENS 
and Sec. 45-19 for an explanation of coverage of TENS for acute post-
operative pain.)
65-8  ELECTRICAL NERVE STIMULATORS
    Two general classifications of electrical nerve stimulators are 
employed to treat chronic intractable pain: peripheral nerve 
stimulators and central nervous system stimulators.
    A. Implanted Peripheral Nerve Stimulators.--Payment may be made 
under the prosthetic device benefit for implanted peripheral nerve 
stimulators. Use of this stimulator involves implantation of electrodes 
around a selected peripheral nerve. The stimulating electrode is 
connected by an insulated lead to a receiver unit which is implanted 
under the skin at a depth not greater than \1/2\ inch. Stimulation is 
induced by a generator connected to an antenna unit which is attached 
to the skin surface over the receiver unit. Implantation of electrodes 
requires surgery and usually necessitates an operating room.

    Note: Peripheral nerve stimulators may also be employed to 
assess a patient's suitability for continued treatment with an 
electric nerve stimulator. As explained in Sec. 35-46, such use of 
the stimulator is covered as part of the total diagnostic service 
furnished to the beneficiary rather than as a prosthesis.

    B. Central Nervous System Stimulators (Dorsal Column and Depth 
Brain Stimulators).--The implantation of central nervous system 
stimulators may be covered as therapies for the relief of chronic 
intractable pain, subject to the following conditions:
    1. Types of Implantations.--There are two types of implantations 
covered by this instruction:
    a. Dorsal Column (Spinal Cord) Neurostimulation.--The surgical 
implantation of neurostimulator electrodes within the dura mater 
(endodural) or the percutaneous insertion of electrodes in the epidural 
space is covered.
    b. Depth Brain Neurostimulation.--The stereotactic implantation of 
electrodes in the deep brain (e.g., thalamus and periaqueductal gray 
matter) is covered.
    2. Conditions for Coverage.--No payment may be made for the 
implantation of dorsal column or depth brain stimulators or services 
and supplies related to such implantation, unless all of the conditions 
listed below have been met:
    a. The implantation of the stimulator is used only as a late resort 
(if not a last resort) for patients with chronic intractable pain;
    b. With respect to item a, other treatment modalities 
(pharmacological, surgical, physical, or psychological therapies) have 
been tried and did not prove satisfactory, or are judged to be 
unsuitable or contraindicated for the given patient;
    c. Patients have undergone careful screening, evaluation and 
diagnosis by a multidisciplinary team prior to implantation. (Such 
screening must include psychological, as well as physical evaluation);
    d. All the facilities, equipment, and professional and support 
personnel required for the proper diagnosis, treatment training, and 
followup of the patient (including that required to satisfy item c) 
must be available; and
    e. Demonstration of pain relief with a temporarily implanted 
electrode precedes permanent implantation.
    Contractors may find it helpful to work with PROs to obtain the 
information needed to apply these conditions to claims. See 
Intermediary Manual, Sec. 3110.4 and Secs. 35-20 and 35-27. Transmittal 
No. 79; sections 35-89-35-92 NEW IMPLEMENTING INSTRUCTIONS--EFFECTIVE 
DATE: For services performed on or after October 11, 1995.
    Section 35-92, Transcendental Meditation.--This section has been 
added to reflect noncoverage of Transcendental meditation (TM) and the 
cost of training patients to practice TM when it is prescribed as a 
treatment of mild hypertension, as adjunctive therapy in the treatment 
of essential hypertension, or as the sole or adjunctive treatment of 
anxiety and other psychological stress-related disorders.
    These instructions are to be implemented within your current 
operating budget.
    DISCLAIMER: The revision date and transmittal number only apply to 
the redlined material. All other material was previously published in 
the manual and is only being reprinted.

35-92  TRANSCENDENTAL MEDITATION--NOT COVERED

    Transcendental Meditation (TM) is a skill that is claimed to 
produce a state of rest and relaxation when practiced effectively. 
Typically, patients are taught TM techniques over the course of several 
sessions by persons trained in TM. The patient then uses the TM 
technique on his or her own to induce the relaxed state. Proponents of 
TM have urged that Medicare cover the training of patients to practice 
TM when it is medically prescribed as treatment for mild hypertension, 
as adjunctive therapy in the treatment of essential hypertension, or as 
the sole or adjunctive treatment of anxiety and other psychological 
stress-related disorders.
    After review of this issue, we have concluded that the evidence 
concerning the medical efficacy of TM is incomplete at best and does 
not demonstrate effectiveness, and that a professional level of skill 
is not required for the training of patients to engage in TM.
    Although many articles have been written about application of TM 
for patients with certain forms of hypertension and anxiety, there are 
no rigorous scientific studies that demonstrate the effectiveness of TM 
for use as an adjunct medical therapy for such conditions. Accordingly, 
neither TM nor the training of patients for its use are covered under 
the Medicare program.

                                           Addendum V.--Regulation Document Published in the Federal Register                                           
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               End of                                   
Publication    FR vol. 60      CFR part             File code *                    Regulation title           comment             Effective date        
    date          page                                                                                         period                                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
07/05/95...     34885-34888          417  OMC-022-F......................  Full Reporting by Health         ...........  08/04/95.                      
                                                                            Maintenance Organizations                                                   
                                                                            (HMOs) and Competitive Medical                                              
                                                                            Plans (CMPs) Paid on a Cost                                                 
                                                                            Basis.                                                                      
07/10/95...     35492-35498          414  BPD-494-F......................  Medicare Program; Payment for    ...........  08/09/95.                      
                                                                            Durable Medical Equipment and                                               
                                                                            Orthotic and Prosthetic                                                     
                                                                            Devices.                                                                    

[[Page 15500]]
                                                                                                                                                        
07/10/95...     34598-35503          433  MB-39-F........................  Medicaid Program; Third Party    ...........  09/08/95.                      
                                                                            Liability (TPL) Cost-                                                       
                                                                            Effectiveness Waivers.                                                      
07/10/95...     35544-35548          405  BP0-121-P......................  Medicare Program; Telephone and     09/08/95  07/10/95.                      
                                                                            Electronic Requests for Review                                              
                                                                            of Part B Initial Claim                                                     
                                                                            Determinations.                                                             
07/18/95...     36733-36736      410 414  BPD-789-CN.....................  Medicare Program; Refinements    ...........  01/01/95.                      
                                                                            to Geographic Adjustment                                                    
                                                                            Factor Values, Revisions to                                                 
                                                                            Payment Policies, Adjustments                                               
                                                                            to the Relative Value Units                                                 
                                                                            (RVUs) Under the Physician Fee                                              
                                                                            Schedule for Calendar Year                                                  
                                                                            1995, and the 5-Year                                                        
                                                                            Refinement of RVUs; Correction.                                             
07/21/95...     37590-37596          413  BPD-409-F......................  Medicare Program; Optional       ...........  08/21/95.                      
                                                                            Payment System for Low                                                      
                                                                            Medicare Volume Skilled                                                     
                                                                            Nursing Facilities.                                                         
07/21/95...     37657-37660  ...........  HSQ-229-N......................  CLIA Program; Approval of the    ...........  07/21/95 through 07/21/97.     
                                                                            American Osteopathic                                                        
                                                                            Association as an Accrediting                                               
                                                                            Organization.                                                               
07/21/95...     37660-37662  ...........  HSQ-228-N......................  CLIA Program; Approval of the    ...........  07/21/95 through 07/21/97.     
                                                                            American Association of Blood                                               
                                                                            Banks.                                                                      
07/26/95...     38266-38272          424  BPD-709-FC.....................  Medicare Program; Allowing          09/25/95  08/25/95.                      
                                                                            Certifications and                                                          
                                                                            Recertification by Nurse                                                    
                                                                            Practitioners and Clinical                                                  
                                                                            Nurse Specialists for Certain                                               
                                                                            Services.                                                                   
07/26/95...     38400-38433      400 413  BPD-827-P......................  Medicare Program; Revisions to      09/25/95  ...............................
                                 405 414                                    Payment Policies Under the                                                  
                                 410 415                                    Physician Fee Schedule for                                                  
                                 411 417                                    Calendar Year 1996.                                                         
                                 412 489                                                                                                                
07/26/95...     38344-38352  ...........  BPO-131-N......................  Medicare and Medicaid Programs;  ...........  ...............................
                                                                            Quarterly Listing of Program                                                
                                                                            Issuances and Coverage                                                      
                                                                            Decisions--First Quarter 1995.                                              
08/01/95...     39122-39123      409 484  BPD-469-CN.....................  Medicare Program; Medicare       ...........  02/21/95.                      
                                                                            Coverage of Home Health                                                     
                                                                            Services, Medicare Conditions                                               
                                                                            of Participation, and Home                                                  
                                                                            Health Aide Supervision;                                                    
                                                                            Correction.                                                                 
08/02/95...     39304-39306      412 485  BPD-825-CN.....................  Medicare Program; Changes to        08/01/95  ...............................
                                 413 489                                    the Hospital Inpatient                                                      
                                     424                                    Prospective Payment Systems                                                 
                                                                            and Fiscal Year 1996 Rates;                                                 
                                                                            Correction.                                                                 
08/09/95...     40594-40597  ...........  ORD-077-N......................  New and Pending Demonstration    ...........  ...............................
                                                                            Project Proposals Submitted                                                 
                                                                            Pursuant to Section 1115(a) of                                              
                                                                            the Social Security Act: May                                                
                                                                            1995.                                                                       
08/14/95...     41914-41982          411  BPD-674-FC.....................  Medicare Program; Physician         10/13/95  09/13/95.                      
                                                                            Financial Relationships With,                                               
                                                                            and Referrals to, Health Care                                               
                                                                            Entities That Furnish Clinical                                              
                                                                            Laboratory Services; Financial                                              
                                                                            Relationship Reporting                                                      
                                                                            Requirements.                                                               
08/14/95...     41893-41894  ...........  OPL-006-N......................  Medicare Program; September 11,  ...........  ...............................
                                                                            1995 Meeting of the Practicing                                              
                                                                            Physicians Advisory Council.                                                
08/28/95...     44503-44507  ...........  HSQ-230-N......................  Medicare, Medicaid, and CLIA     ...........  08/28/95 to 06/30/2001.        
                                                                            Programs; Clinical Laboratory                                               
                                                                            Improvement Amendments of 1988                                              
                                                                            Exemption of Permit- Holding                                                
                                                                            Laboratories in the State of                                                
                                                                            New York.                                                                   
08/30/95...     45085-45086          442  BPD-840-CN.....................  Medicare and Medicaid Programs;  ...........  02/08/95, 04/24/95, and 07/01/ 
                                     486                                    Technical Amendatory Language                 95.                           
                                     493                                    Changes; Correction.                                                        
08/31/95...     45344-45372      400 411  BPD-482-FC.....................  Medicare Program; Medicare          10/30/95  10/02/95.                      
                                                                            Secondary Payer for                                                         
                                                                            Individuals Entitled to                                                     
                                                                            Medicare and Also Covered                                                   
                                                                            Under Group Health Plans.                                                   
08/31/95...           45372  ...........  OMC-022-F......................  Full Reporting by Health         ...........  08/04/95.                      
                                                                            Maintenance Organizations                                                   
                                                                            (HMOs) and Competitive Medical                                              
                                                                            Plans (CMPs) Paid on a Cost                                                 
                                                                            Basis.                                                                      
09/01/95...     45673-45682          417  OMC-011-FC.....................  Medicare Program; Contracts         10/31/95  10/01/95.                      
                                                                            With Health Maintenance                                                     
                                                                            Organizations (HMOS) and                                                    
                                                                            Competitive Medical Plans                                                   
                                                                            (CMPs).                                                                     

[[Page 15501]]
                                                                                                                                                        
09/01/95...     45778-45946      412 485  BPD-825-FC.....................  Medicare Program; Changes to        10/31/95  10/01/95; except Sec.  412.46  
                                 413 489                                    the Hospital Inpatient                        which is effective 09/01/95.  
                                     424                                    Prospective Payment Systems                                                 
                                                                            and Fiscal Year 1996 Rates.                                                 
09/06/95...     46228-46234          417  OMC-014-FC.....................  Medicare Program; Payments to       10/06/95  10/01/95.                      
                                                                            HMOs and CMPs and Appeals;                                                  
                                                                            Technical Amendments.                                                       
09/06/95...     46288-46296  ...........  BPO-133-PN.....................  Medicare Program; Data,             11/06/95  ...............................
                                                                            Standards, and Methodology                                                  
                                                                            Used to Establish Fiscal Year                                               
                                                                            1996 Budgets for Fiscal                                                     
                                                                            Intermediaries and Carriers.                                                
09/08/95...     46838-46841  ...........  MB-094-N.......................  Medicaid Program; Limitations      09/30/95.                                 
                                                                            on Aggregate Payments to                                                    
                                                                            Disproportionate Share                                                      
                                                                            Hospitals: Federal Fiscal Year                                              
                                                                            1995.                                                                       
09/13/95...     47534-47543          493  HSQ-225-P......................  Public Health Service; CLIA         11/13/95  ...............................
                                                                            Program; Categorization of                                                  
                                                                            Waived Tests.                                                               
09/15/95...     47982-47998          493  HSQ-222-P......................  CLIA Program; Categorization        11/14/95  ...............................
                                                                            and Certification Requirements                                              
                                                                            for a New Subcategory of                                                    
                                                                            Moderate Complexity Testing.                                                
09/18/95...     48039-48044          405  BPD-766-F......................  Medicare Program; Standards for  ...........  10/18/95.                      
                                                                            Quality of Water Used in                                                    
                                                                            Dialysis and Revised                                                        
                                                                            Guidelines on Reuse of                                                      
                                                                            Hemodialysis Filters for End-                                               
                                                                            Stage Renal Disease (ESRD)                                                  
                                                                            Patients.                                                                   
09/19/95...     48417-48425      405 411  BPD-841-FC.....................  Medicare Program; Criteria and      11/20/95  11/01/95.                      
                                                                            Procedures for Extending                                                    
                                                                            Coverage to Certain Devices                                                 
                                                                            and Related Services.                                                       
09/19/95...     48442-48490      441 447  MB-046-P.......................  Medicaid Program; Payment for       11/20/95  ...............................
                                                                            Covered Outpatient Drugs Under                                              
                                                                            Drug Rebate Agreements With                                                 
                                                                            Manufacturers.                                                              
09/20/95...           48749      400 411  BPD-482-FC.....................  Medicare Program; Medicare       ...........  09/29/95.                      
                                                                            Secondary Payer for                                                         
                                                                            Individuals Entitled to                                                     
                                                                            Medicare and Also Covered                                                   
                                                                            Under Group Health Plans;                                                   
                                                                            Correction.                                                                 
09/26/95...     49619-49622  ...........  BPD-824-N......................  Medicare Program; Update of      ...........  10/01/95.                      
                                                                            Ambulatory Surgical Center                                                  
                                                                            (ASC) Payment Rates Effective                                               
                                                                            for Services On or After                                                    
                                                                            October 1, 1995.                                                            
09/28/95...     50115-50120      431 488  HSQ-156-CN.....................  Medicare and Medicaid Programs;  ...........  07/01/95.                      
                                 440 489                                    Survey, Certification and                                                   
                                 442 498                                    Enforcement of Skilled Nursing                                              
                                                                            Facilities and Nursing                                                      
                                                                            Facilities; Correction.                                                     
09/29/95...     50439-50443      401 473  BPD-830-FC.....................  Medicare Program; Authority         11/28/95  09/29/95.                      
                                 403 476                                    Citations: Technical                                                        
                                 409 482                                    Amendments.                                                                 
                                 413 483                                                                                                                
                                 420 484                                                                                                                
                                 421 488                                                                                                                
                                 424 489                                                                                                                
                                 462 498                                                                                                                
                                     466                                                                                                                
09/29/95...     50443-50446          400  OFH-018-F......................  Medicare and Medicaid Programs;  ...........  09/29/95.                      
                                                                            Approved Information                                                        
                                                                            Collection Requirements.                                                    
09/29/95...     50446-50448      485 486  BPD-836-FC.....................  Medicare Program; Providers and     11/28/95  09/29/95.                      
                                                                            Suppliers of Specialized                                                    
                                                                            Services: Technical Amendments.                                             
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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/

[[Page 15502]]
Investigational (Category B) Devices. Under this categorization 
process, an experimental/investigational device (Category A) 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 A include the following:
    (1) Class III devices of a type for which no marketing application 
has been approved through the premarket approval (PMA) process for any 
indication for use. (For pre-amendments 1 Class III devices, refer 
to the criteria under Category B).

     1 Pre-amendments devices are devices that were marketed 
before the enactment of the 1976 Medical Device Amendments to the 
Food, Drug, and Cosmetic Act; that is, in commercial distribution 
before May 28, 1976.
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    (2) Class III devices that would otherwise be in Category B but 
have undergone significant modification for a new indication for use.
    The following information presents the device number, category (in 
this case, A), and criterion code for FDA approved IDE devices.

L002702 A 1, L014521 A 1, G840208 A 1, G870031 A 1, G870181 A 2, 
G880028 A 1, G880063 A 1, G880151 A 1, G880210 A 2, G890047 A 1, 
G890103 A 1, G890144 A 2, G890148 A 1, G890189 A 1, G890201 A 2, 
G890210 A 2, G900100 A 2, G900142 A 2, G900143 A 2, G900155 A 1, 
G900205 A 1, G900214 A 1, G900217 A 1, G900246 A 2, G900259 A 2, 
G910034 A 1, G910064 A 2, G910078 A 2, G910083 A 1, G910121 A 1, 
G910130 A 1, G910166 A 2, G910170 A 2, G910175 A 2, G910197 A 2, 
G910202 A 2, G920003 A 1, G920021 A 1, G920035 A 1, G920045 A 2, 
G920046 A 1, G920052 A 2, G920084 A 2, G920101 A 1, G920111 A 1, 
G920211 A 1, G930054 A 2, G930063 A 1, G930092 A 1, G930115 A 2, 
G930136 A 1, G930140 A 1, G930155 A 1, G930190 A 2, G930192 A 2, 
G940001 A 1, G940024 A 1, G940084 A 2, G940088 A 2, G940111 A 2, 
G940119 A 2, G940150 A 1, G940151 A 2, G940191 A 1, G940192 A 1, 
G950058 A 2, G950062 A 1, G950083 A 2, G950093 A 1, G950096 A 1

    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 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, B), and criterion code.

L010038 B 1, L010109 B 2, L010119 B 2, L010598 B 2, L010913 B 2, 
L011828 B 2, L013468 B 2, L013469 B 2, L016548 B 1, L017238 B 3, 
G780049 B 2, G780054 B 2, G790001 B 2, G790011 B 6, G790012 B 2, 
G790016 B 1, G790018 B 2, G790022 B 2, G790023 B 2, G790030 B 2, 
G790033 B 1, G800001 B 2, G800002 B 2, G800004 B 2, G800007 B 1, 
G800017 B 5, G800020 B 1, G800022 B 2, G800024 B 2, G800035 B 3, 
G800046 B 1, G800049 B 2, G800055 B 2, G800074 B 2, G800075 B 1, 
G800077 B 2, G800083 B 4, G800124 B 2, G800129 B 3, G800138 B 2, 
G800143 B 4, G810003 B 2, G810022 B 2, G810028 B 2, G810065 B 2, 
G810067 B 4, G810068 B 2, G810076 B 2, G810080 B 1, G810081 B 1, 
G810083 B 2, G810086 B 1, G810089 B 2, G810102 B 1, G810109 B 2, 
G810113 B 1, G810115 B 3, G810122 B 2, G810123 B 2, G810127 B 2, 
G810128 B 2, G810129 B 1, G810134 B 1, G810138 B 2, G810139 B 1, 
G810149 B 2, G810161 B 2, G810168 B 1, G810171 B 2, G810172 B 2, 
G810173 B 2, G810178 B 2, G810192 B 2, G810203 B 2, G810216 B 2, 
G810218 B 2, G820012 B 2, G820019 B 2, G820033 B 1, G820036 B 2, 
G820046 B 2, G820050 B 2, G820054 B 2, G820057 B 2, G820061 B 3, 
G820073 B 1, G820076 B 2, G820080 B 1, G820082 B 2, G820094 B 4, 
G820096 B 2, G820098 B 2, G820115 B 2, G820138 B 2, G820149 B 2, 
G820157 B 2, G820165 B 2, G820903 B 1, G820904 B 1, G830017 B 4, 
G830027 B 2, G830044 B 2, G830048 B 2, G830073 B 4, G830092 B 4, 
G830120 B 2, G830127 B 2, G830134 B 1, G830145 B 2, G830153 B 1, 
G830154 B 4, G830167 B 2, G830174 B 2, G830187 B 2, G830901 B 1, 
G830903 B 1, G830907 B 2, G840008 B 1, G840018 B 1, G840028 B 3, 
G840032 B 1, G840036 B 2, G840069 B 1, G840080 B 2, G840098 B 2, 
G840099 B 1, G840129 B 1, G840135 B 2, G840137 B 6, G840140 B 2, 
G840150 B 1, G840174 B 2, G840189 B 2, G840196 B 2, G840201 B 2, 
G850010 B 2, G850012 B 1, G850017 B 1, G850030 B 2, G850040 B 2, 
G850045 B 1, G850049 B 2, G850071 B 2, G850072 B 1, G850097 B 2, 
G850098 B 2, G850101 B 3, G850103 B 4, G850117 B 3, G850120 B 2, 
G850121 B 2, G850134 B 2, G850139 B 2, G850142 B 1, G850158 B 4, 
G850162 B 2, G850174 B 2, G850187 B 2, G850188 B 3, G850202 B 2, 
G850206 B 2, G850217 B 2, G850231 B 2, G850233 B 4, G850239 B 2, 
G860001 B 1, G860010 B 2, G860019 B 4, G860021 B 1, G860026 B 2, 
G860030 B 4, G860044 B 2, G860055 B 2, G860060 B 2, G860065 B 3, 
G860066 B 2, G860067 B 2, G860070 B 3, G860075 B 2, G860077 B 2, 
G860084 B 1, G860086 B 2, G860102 B 1, G860114 B 2, G860116 B 1, 
G860117 B 2, G860118 B 1, G860132 B 2, G860138 B 2, G860140 B 4, 
G860141 B 4, G860147 B 4, G860156 B 2, G860157 B 1, G860165 B 4, 
G860168 B 2, G860169 B 2, G860170 B 2, G860172 B 2, G860176 B 1, 
G860182 B 2, G860184 B 4, G860186 B 2, G860189 B 1, G860194 B 2, 
G860199 B 2, G860200 B 2, G860201 B 1, G860210 B 1, G860225 B 2, 
G860230 B 4, G870010 B 4, G870013 B 1,

[[Page 15503]]
G870017 B 1, G870019 B 3, G870030 B 2, G870035 B 2, G870036 B 2, 
G870037 B 2, G870038 B 6, G870040 B 3, G870046 B 2, G870048 B 4, 
G870049 B 1, G870052 B 1, G870053 B 2, G870055 B 6, G870056 B 6, 
G870058 B 1, G870060 B 1, G870061 B 6, G870067 B 2, G870069 B 4, 
G870080 B 2, G870082 B 2, G870091 B 1, G870101 B 4, G870104 B 2, 
G870109 B 2, G870112 B 1, G870114 B 2, G870120 B 2, G870122 B 6, 
G870123 B 2, G870129 B 2, G870134 B 6, G870136 B 2, G870142 B 4, 
G870144 B 4, G870158 B 6, G870161 B 2, G870163 B 2, G870167 B 1, 
G870174 B 2, G870195 B 2, G870200 B 2, G870213 B 2, G870224 B 2, 
G880001 B 1, G880007 B 3, G880008 B 4, G880018 B 4, G880021 B 2, 
G880022 B 3, G880026 B 1, G880032 B 3, G880040 B 2, G880042 B 1, 
G880044 B 2, G880045 B 1, G880050 B 6, G880051 B 2, G880068 B 2, 
G880069 B 3, G880076 B 1, G880080 B 2, G880084 B 2, G880100 B 2, 
G880102 B 1, G880103 B 1, G880104 B 1, G880112 B 3, G880118 B 4, 
G880122 B 2, G880123 B 6, G880129 B 2, G880131 B 2, G880136 B 6, 
G880149 B 4, G880150 B 2, G880152 B 2, G880153 B 2, G880155 B 2, 
G880157 B 6, G880159 B 1, G880167 B 2, G880170 B 3, G880174 B 6, 
G880184 B 2, G880186 B 2, G880188 B 2, G880189 B 4, G880191 B 2, 
G880193 B 2, G880194 B 2, G880197 B 4, G880208 B 1, G880213 B 3, 
G880214 B 4, G880221 B 4, G880228 B 4, G880233 B 6, G880234 B 2, 
G880235 B 6, G880257 B 3, G880280 B 1, G880286 B 3, G880290 B 2, 
G880294 B 2, G880295 B 2, G880296 B 1, G880298 B 6, G880300 B 2, 
G880301 B 2, G890001 B 3, G890003 B 6, G890005 B 2, G890006 B 2, 
G890008 B 3, G890009 B 4, G890018 B 2, G890021 B 2, G890022 B 4, 
G890027 B 3, G890029 B 2, G890030 B 1, G890031 B 2, G890039 B 1, 
G890040 B 6, G890045 B 2, G890048 B 4, G890050 B 4, G890055 B 1, 
G890058 B 2, G890060 B 2, G890064 B 3, G890074 B 4, G890077 B 4, 
G890078 B 2, G890081 B 1, G890084 B 6, G890088 B 3, G890092 B 2, 
G890096 B 1, G890097 B 6, G890099 B 2, G890101 B 4, G890104 B 6, 
G890108 B 4, G890110 B 2, G890112 B 2, G890122 B 2, G890124 B 2, 
G890130 B 2, G890137 B 4, G890138 B 3, G890140 B 2, G890149 B 2, 
G890151 B 2, G890152 B 2, G890158 B 6, G890161 B 4, G890165 B 1, 
G890169 B 3, G890173 B 3, G890177 B 3, G890179 B 2, G890180 B 4, 
G890181 B 2, G890183 B 2, G890185 B 4, G890190 B 2, G890191 B 1, 
G890196 B 3, G890197 B 2, G890198 B 6, G890200 B 2, G890208 B 2, 
G890209 B 1, G890211 B 1, G890215 B 4, G890216 B 2, G890222 B 2, 
G890227 B 1, G890231 B 2, G890232 B 1, G890234 B 3, G890235 B 3, 
G890236 B 4, G890239 B 2, G890245 B 2, G890248 B 1, G890249 B 2, 
G890250 B 2, G900005 B 1, G900006 B 2, G900007 B 2, G900008 B 4, 
G900010 B 2, G900017 B 2, G900019 B 4, G900020 B 2, G900022 B 2, 
G900027 B 4, G900028 B 2, G900030 B 1, G900040 B 2, G900041 B 2, 
G900044 B 2, G900045 B 1, G900049 B 2, G900050 B 2, G900053 B 1, 
G900055 B 2, G900058 B 2, G900059 B 2, G900060 B 2, G900062 B 2, 
G900075 B 2, G900077 B 1, G900078 B 4, G900081 B 1, G900085 B 1, 
G900090 B 6, G900092 B 1, G900093 B 6, G900098 B 2, G900099 B 4, 
G900101 B 2, G900102 B 4, G900104 B 6, G900107 B 4, G900108 B 4, 
G900109 B 2, G900110 B 2, G900113 B 6, G900119 B 2, G900122 B 2, 
G900127 B 2, G900128 B 2, G900130 B 2, G900134 B 2, G900138 B 4, 
G900139 B 2, G900141 B 1, G900145 B 4, G900147 B 2, G900152 B 2, 
G900154 B 2, G900156 B 4, G900157 B 2, G900158 B 2, G900163 B 2, 
G900164 B 2, G900166 B 2, G900167 B 4, G900168 B 2, G900175 B 4, 
G900179 B 2, G900191 B 1, G900192 B 2, G900193 B 3, G900196 B 3, 
G900197 B 3, G900198 B 4, G900204 B 4, G900206 B 2, G900207 B 1, 
G900209 B 4, G900216 B 2, G900219 B 2, G900222 B 2, G900225 B 1, 
G900226 B 2, G900228 B 2, G900231 B 6, G900233 B 2, G900237 B 3, 
G900240 B 1, G900241 B 1, G900243 B 2, G900247 B 2, G900248 B 6, 
G900249 B 2, G900250 B 4, G900251 B 3, G900255 B 3, G900258 B 3, 
G900262 B 4, G910002 B 1, G910005 B 6, G910006 B 3, G910008 B 2, 
G910009 B 1, G910016 B 2, G910018 B 2, G910026 B 3, G910028 B 2, 
G910029 B 1, G910035 B 1, G910037 B 4, G910040 B 3, G910044 B 4, 
G910047 B 2, G910052 B 2, G910055 B 1, G910057 B 6, G910058 B 4, 
G910061 B 2, G910062 B 4, G910067 B 4, G910068 B 2, G910072 B 2, 
G910073 B 1, G910080 B 1, G910082 B 1, G910084 B 4, G910085 B 1, 
G910087 B 2, G910089 B 2, G910095 B 2, G910098 B 4, G910101 B 4, 
G910102 B 1, G910104 B 4, G910108 B 4, G910109 B 4, G910112 B 2, 
G910113 B 2, G910115 B 1, G910124 B 3, G910125 B 4, G910127 B 1, 
G910128 B 1, G910129 B 1, G910132 B 4, G910133 B 3, G910134 B 2, 
G910138 B 2, G910144 B 4, G910145 B 3, G910146 B 2, G910147 B 3, 
G910153 B 2, G910154 B 3, G910160 B 1, G910161 B 2, G910162 B 4, 
G910164 B 4, G910165 B 4, G910171 B 2, G910172 B 2, G910176 B 2, 
G910177 B 3, G910178 B 2, G910184 B 3, G910186 B 3, G910187 B 1, 
G910188 B 4, G910192 B 6, G910193 B 4, G910195 B 1, G910199 B 3, 
G910200 B 4, G910201 B 4, G910203 B 4, G910205 B 4, G910207 B 1, 
G910210 B 2, G910211 B 4, G910212 B 2, G910213 B 3, G910216 B 2, 
G910218 B 4, G920006 B 2, G920007 B 2, G920015 B 4, G920016 B 3, 
G920018 B 2, G920024 B 1, G920028 B 3, G920029 B 2, G920036 B 6, 
G920037 B 4, G920040 B 1, G920042 B 2, G920044 B 1, G920047 B 2, 
G920049 B 2, G920051 B 1, G920053 B 2, G920057 B 1, G920059 B 3, 
G920060 B 2, G920062 B 2, G920063 B 4, G920070 B 2, G920071 B 2, 
G920072 B 2, G920074 B 1, G920075 B 2, G920077 B 4, G920078 B 1, 
G920079 B 3, G920080 B 4, G920082 B 1, G920083 B 2, G920086 B 2, 
G920087 B 2, G920088 B 2, G920089 B 2, G920090 B 4, G920092 B 2, 
G920094 B 2, G920096 B 1, G920097 B 4, G920099 B 2, G920100 B 2, 
G920102 B 2, G920104 B 1, G920105 B 2, G920106 B 4, G920107 B 2, 
G920108 B 4, G920110 B 2, G920112 B 2, G920114 B 1, G920118 B 2, 
G920119 B 2, G920120 B 2, G920122 B 1, G920123 B 2, G920125 B 1, 
G920126 B 2, G920127 B 1, G920129 B 2, G920130 B 2, G920131 B 1, 
G920135 B 1, G920138 B 1, G920139 B 2, G920142 B 2, G920143 B 2, 
G920144 B 2, G920145 B 2, G920148 B 4, G920150 B 2, G920151 B 2, 
G920154 B 6, G920155 B 2, G920157 B 2, G920160 B 2, G920161 B 6, 
G920162 B 4, G920163 B 2, G920164 B 6, G920165 B 2, G920166 B 1, 
G920168 B 1, G920169 B 1, G920170 B 2, G920171 B 2, G920173 B 3, 
G920176 B 6, G920177 B 1, G920178 B 2, G920179 B 1, G920181 B 3, 
G920183 B 2, G920189 B 2, G920191 B 2, G920193 B 1, G920196 B 2, 
G920199 B 2, G920200 B 2, G920203 B 4, G920206 B 4, G920208 B 2, 
G920212 B 1, G920214 B 3, G920215 B 1, G920218 B 2, G920219 B 1, 
G920222 B 1, G920224 B 2, G920225 B 1, G920228 B 4, G920230 B 2, 
G920235 B 3, G920237 B 4, G920239 B 2, G920241 B 2, G920244 B 2, 
G920245 B 4, G920249 B 2, G920251 B 2, G920252 B 2, G920253 B 1, 
G920254 B 4, G920255 B 2, G920256 B 4, G920257 B 4, G930006 B 1, 
G930009 B 2, G930011 B 6, G930012 B 2, G930015 B 1, G930017 B 2, 
G930018 B 2, G930023 B 2, G930024 B 1, G930026 B 2, G930029 B 4,

[[Page 15504]]
G930030 B 3, G930031 B 3, G930032 B 1, G930036 B 2, G930037 B 2, 
G930039 B 2, G930041 B 6, G930043 B 4, G930045 B 4, G930053 B 4, 
G930057 B 6, G930058 B 2, G930061 B 1, G930062 B 1, G930069 B 1, 
G930071 B 2, G930073 B 3, G930074 B 2, G930075 B 2, G930076 B 2, 
G930077 B 3, G930078 B 2, G930079 B 4, G930081 B 2, G930082 B 2, 
G930084 B 4, G930085 B 1, G930086 B 2, G930087 B 4, G930090 B 2, 
G930091 B 2, G930097 B 2, G930099 B 3, G930102 B 4, G930104 B 2, 
G930107 B 2, G930108 B 4, G930109 B 3, G930113 B 2, G930114 B 2, 
G930116 B 4, G930117 B 2, G930119 B 3, G930121 B 2, G930127 B 3, 
G930129 B 2, G930130 B 1, G930135 B 2, G930137 B 2, G930141 B 2, 
G930142 B 4, G930143 B 6, G930146 B 6, G930147 B 2, G930150 B 4, 
G930151 B 4, G930152 B 4, G930154 B 2, G930159 B 2, G930160 B 1, 
G930162 B 2, G930163 B 2, G930165 B 4, G930166 B 2, G930167 B 1, 
G930168 B 1, G930169 B 2, G930172 B 4, G930173 B 4, G930174 B 4, 
G930175 B 2, G930176 B 2, G930178 B 4, G930180 B 1, G930182 B 3, 
G930183 B 2, G930184 B 1, G930185 B 3, G930187 B 3, G930188 B 1, 
G930191 B 4, G930194 B 1, G930196 B 2, G930198 B 4, G930201 B 2, 
G930204 B 6, G930208 B 4, G930209 B 3, G930210 B 2, G930213 B 2, 
G940002 B 4, G940003 B 3, G940004 B 3, G940005 B 3, G940006 B 1, 
G940008 B 3, G940009 B 3, G940012 B 2, G940015 B 3, G940019 B 2, 
G940020 B 6, G940022 B 1, G940023 B 3, G940026 B 3, G940027 B 2, 
G940030 B 4, G940031 B 2, G940032 B 2, G940033 B 6, G940034 B 2, 
G940036 B 4, G940038 B 2, G940040 B 1, G940041 B 1, G940042 B 2, 
G940043 B 4, G940044 B 2, G940045 B 1, G940050 B 2, G940051 B 4, 
G940052 B 2, G940056 B 4, G940058 B 2, G940059 B 4, G940060 B 1, 
G940061 B 4, G940063 B 2, G940064 B 4, G940065 B 4, G940066 B 3, 
G940067 B 4, G940069 B 2, G940070 B 1, G940071 B 3, G940072 B 3, 
G940073 B 2, G940075 B 1, G940076 B 1, G940077 B 3, G940085 B 2, 
G940086 B 3, G940087 B 3, G940089 B 2, G940090 B 4, G940091 B 1, 
G940092 B 6, G940093 B 2, G940094 B 3, G940096 B 3, G940101 B 1, 
G940103 B 1, G940105 B 2, G940106 B 1, G940107 B 6, G940108 B 2, 
G940110 B 1, G940112 B 2, G940113 B 2, G940115 B 6, G940116 B 1, 
G940117 B 3, G940120 B 2, G940122 B 1, G940125 B 2, G940126 B 2, 
G940127 B 3, G940131 B 2, G940133 B 1, G940135 B 1, G940138 B 6, 
G940140 B 6, G940141 B 4, G940143 B 1, G940147 B 1, G940149 B 1, 
G940154 B 4, G940155 B 3, G940156 B 3, G940157 B 2, G940158 B 2, 
G940160 B 4, G940162 B 1, G940163 B 4, G940164 B 2, G940165 B 4, 
G940167 B 4, G940168 B 2, G940169 B 1, G940171 B 3, G940172 B 2, 
G940176 B 3, G940177 B 2, G940178 B 3, G940184 B 3, G940186 B 2, 
G940188 B 3, G940193 B 2, G940194 B 3, G950001 B 1, G950002 B 1, 
G950003 B 4, G950004 B 4, G950005 B 2, G950006 B 3, G950009 B 3, 
G950010 B 2, G950011 B 1, G950012 B 1, G950013 B 2, G950014 B 3, 
G950015 B 4, G950016 B 3, G950017 B 4, G950018 B 4, G950019 B 3, 
G950020 B 1, G950021 B 1, G950023 B 1, G950024 B 1, G950025 B 2, 
G950026 B 4, G950027 B 1, G950028 B 1, G950029 B 3, G950030 B 1, 
G950031 B 1, G950032 B 2, G950033 B 2, G950034 B 2, G950035 B 3, 
G950037 B 1, G950038 B 4, G950040 B 2, G950041 B 3, G950043 B 3, 
G950044 B 2, G950045 B 2, G950046 B 1, G950047 B 3, G950048 B 3, 
G950049 B 3, G950051 B 4, G950053 B 2, G950055 B 2, G950056 B 1, 
G950057 B 4, G950059 B 6, G950060 B 1, G950063 B 3, G950065 B 2, 
G950067 B 2, G950068 B 1, G950069 B 4, G950072 B 2, G950073 B 2, 
G950074 B 3, G950075 B 4, G950076 B 2, G950077 B 1, G950078 B 3, 
G950080 B 3, G950081 B 3, G950084 B 3, G950086 B 2, G950087 B 3, 
G950088 B 1, G950089 B 4, G950092 B 1, G950095 B 4, G950098 B 1, 
G950099 B 2, G950101 B 2, G950104 B 4, G950106 B 4, G950107 B 3, 
G950108 B 4, G950109 B 6, G950110 B 6, G950111 B 2, G950113 B 4, 
G950114 B 4, G950116 B 4, G950117 B 2, G950118 B 4, G950120 B 1, 
G950122 B 2, G950123 B 1, G950124 B 1, G950125 B 2, G950127 B 4, 
G950130 B 4, G950131 B 4, G950133 B 4, G950134 B 2, G950135 B 2, 
G950137 B 4, G950139 B 2, G950146 B 3, G950148 B 1, G950149 B 2, 
G950150 B 4, G950151 B 4, G950154 B 3, G950159 B 4, G950160 B 1, 
G950162 B 3, G950164 B 3.

    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. 96-8623 Filed 4-5-96; 8:45 am]
BILLING CODE 4120-03-P