[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Notices]
[Pages 59358-59365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[BPO-150-N]


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

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

ACTION: Notice.

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

SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during January, February, and March of 1997 that relate to 
the Medicare and Medicaid programs. It also identifies certain devices 
with investigational device exemption numbers approved by the Food and 
Drug Administration that may be potentially covered under Medicare.
    Section 1871(c) of the Social Security Act requires that we publish 
a list of Medicare issuances in the Federal Register at least every 3 
months. Although we are not mandated to do so

[[Page 59359]]

by statute, for the sake of completeness of the listing, we are 
including all Medicaid issuances and Medicare and Medicaid substantive 
and interpretive regulations (proposed and final) published during this 
time frame.

FOR FURTHER INFORMATION CONTACT:

Bridget Wilhite, (410) 786-5248 (For Medicare instruction information).
Betty Stanton, (410) 786-3247 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Cathy Johnson, (410) 786-5241 (For all other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs, which pay for health 
care and related services for 38 million Medicare beneficiaries and 36 
million Medicaid recipients. Administration of these programs involves 
(1) providing information to Medicare beneficiaries and Medicaid 
recipients, health care providers, and the public, and (2) effective 
communications with regional offices, State governments, State Medicaid 
Agencies, State Survey Agencies, various providers of health care, 
fiscal intermediaries and carriers that process claims and pay bills, 
and others. To implement the various statutes on which the programs are 
based, we issue regulations under the authority granted the Secretary 
under sections 1102, 1871, and 1902 and related provisions of the 
Social Security Act (the Act) and also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, and guidelines of general 
applicability not issued as regulations. We published our first notice 
June 9, 1988 (53 FR 21730). Although we are not mandated to do so by 
statute, for the sake of completeness of the listing of operational and 
policy statements, we are continuing our practice of including Medicare 
substantive and interpretive regulations (proposed and final) published 
during the 3-month time frame. Since the publication of our quarterly 
listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid 
issuances to our quarterly listings. Accordingly, we list in this 
notice Medicaid issuances and Medicaid substantive and interpretive 
regulations published during January through March 1997.

II. How to Use the Addenda

    This notice is organized so that a reader may review the subjects 
of all manual issuances, memoranda, substantive and interpretive 
regulations, or Food and Drug Administration-approved investigational 
device exemptions published during the time frame to determine whether 
any are of particular interest. We expect it to be used in concert with 
previously published notices. Most notably, those unfamiliar with a 
description of our Medicare manuals may wish to review Table I of our 
first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the 
notice published March 31, 1993 (58 FR 16837), and those desiring 
information on the Medicare Coverage Issues Manual may wish to review 
the August 21, 1989 publication (54 FR 34555).
    To aid the reader, we have organized and divided this current 
listing into five addenda. Addendum I lists the publication dates of 
the most recent quarterly listings of program issuances.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. Often it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
    Addendum IV lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice. For each item, we 
list the date published, the Federal Register citation, the parts of 
the Code of Federal Regulations (CFR) that have changed (if 
applicable), the agency file code number, the title of the regulation, 
the ending date of the comment period (if applicable), and the 
effective date (if applicable).
    On September 19, 1995, we published a final rule (60 FR 48417) 
establishing in regulations at 42 CFR 405.201 et seq. that certain 
devices with an investigational device exemption approved by the Food 
and Drug Administration and certain services related to those devices 
may be covered under Medicare. 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 V includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved or revised during the quarter 
covered by this notice. The listings are organized according to the 
categories to which the device numbers are assigned (that is, Category 
A or Category B) and identified by the investigational device exemption 
number.

III. How To Obtain Listed Material

A. Manuals

    An individual or organization interested in routinely receiving any 
manual and revisions to it may purchase a subscription to that manual. 
Those wishing to subscribe should contact either the Government 
Printing Office (GPO) or the National Technical Information Service 
(NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New 
Orders, PO Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-
1800, Fax number (202) 512-2250 (for credit card orders).
National Technical Information Service, Department of Commerce, 5825 
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

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

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both

[[Page 59360]]

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

C. Rulings

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

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

    Our laws, regulations, and manuals are also available on CD-ROM, 
which may be purchased from GPO or NTIS on a subscription or single 
copy basis. The Superintendent of Documents list ID is HCLRM, and the 
stock number is 717-139-00000-3. The following material is on the CD-
ROM disk:
    <bullet> Titles XI, XVIII, and XIX of the Social Security Act.
    <bullet> HCFA-related regulations.
    <bullet> HCFA manuals and monthly revisions.
    <bullet> HCFA program memoranda.
    The titles of the Compilation of the Social Security Act are 
current as of January 1, 1995. The remaining portions of CD-ROM are 
updated on a monthly basis.
    Because of complaints about the unreadability of the Appendices 
(Interpretive Guidelines) in the State Operations Manual (SOM), as of 
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future, and, with the aid of newer 
technology, we may again be able to include the appendices on CD-ROM.
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the 
reports once the files have been copied to a personal computer disk.

IV. How to Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 1400 designated libraries 
throughout the United States. Interested parties may examine the 
documents at any one of the FDLs. Some may have arrangements to 
transfer material to a local library not designated as an FDL. To 
locate the nearest FDL, contact any library.
    In addition, individuals may contact regional depository libraries, 
which receive and retain at least one copy of most Federal government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library. Superintendent of Documents 
numbers for each HCFA publication are shown in Addendum III, along with 
the HCFA publication and transmittal numbers. To help FDLs locate the 
instruction, use the Superintendent of Documents number, plus the HCFA 
transmittal number. For example, to find the Intermediary Manual, Part 
3--Claims Process (HCFA Pub 13-3) transmittal entitled ``Oral Cancer 
Drugs,'' use the Superintendent of Documents No. HE 22.8/6 and the HCFA 
transmittal number 1700.

V. General Information

    It is possible that an interested party may have a specific 
information need and not be able to determine from the listed 
information whether the issuance or regulation would fulfill that need. 
Consequently, we are providing information contact persons to answer 
general questions concerning these items. Copies are not available 
through the contact persons. Copies can be purchased or reviewed as 
noted above.
    Questions concerning Medicare items in Addendum III may be 
addressed to Bridget Wilhite, Office of Communications and Operations 
Support, Division of Regulations and Issuances, Health Care Financing 
Administration, Telephone (410) 786-5248.
    Questions concerning Medicaid items in Addendum III may be 
addressed to Betty Stanton, Center for Medicaid State Operations, 
Policy Coordination and Planning Group, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-3247.
    Questions concerning Food and Drug Administration-approved 
investigational device exemptions may be addressed to Sharon Hippler, 
Office of Clinical Standards and Quality, Coverage Analysis Group, 
Health Care Financing Administration, C4-11-04, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.
    Questions concerning all other information may be addressed to 
Cathy Johnson, Office of Communications and Operations Support, 
Division of Regulations and Issuances, Health Care Financing 
Administration, C5-12-16, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-5241.

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

    Dated: October 10, 1997.
Pamela J. Gentry,
Director, Office of Communications and Operations Support.

Addendum I

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

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

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

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

[[Page 59361]]



        Addendum III.--Medicare and Medicaid Manual Instructions        
                    [January 1997 through March 1997]                   
------------------------------------------------------------------------
   Trans. No.                     Manual/Subject/Publication No.        
------------------------------------------------------------------------
       Intermediary Manual Part 3--Claims Process (HCFA Pub. 13-3)      
               (Superintendent of Documents No. HE 22.8/6)              
------------------------------------------------------------------------
1696              <all>   Review of Form HCFA-1450 for Inpatient and    
                           Outpatient Bills.                            
                          Bill Review for Partial Hospitalization       
                           Services Provided in Community Mental Health 
                           Centers.                                     
                          Pneumoccocal Pneumonia Influenza Virus and    
                           Hepatitis B Vaccines.                        
1697              <all>   Laboratory Tests for Hemodialysis,            
                           Intermittent Peritoneal Dialysis and         
                           Continuous Cycling Peritoneal Dialysis       
                           Included in Composite Rate.                  
                          Laboratory Tests for CAPD Covered Routinely   
                           and Separately Billable.                     
1698              <all>   Review of Form HCFA-1450 for Inpatient and    
                           Outpatient Bills.                            
                          Review of Hospice Bills.                      
1699              <all>   Medical--Subject to Waiver.                   
1700              <all>   Oral Cancer Drugs.                            
                          Self-Administered Antiemetic Drugs            
                          Mammography Quality Standards Act.            
1701              <all>   Hospital Outpatient Partial Hospitalization   
                           Services.                                    
1702              <all>   Billing for Durable Medical Equipment Orthotic/
                           Prosthetic Devices and Surgical Dressings.   
1703              <all>   Applicability of Limitation on Liability to   
                           Items or Services Furnished by Providers of  
                           Services Payable Under Part A                
                          When to Make Limitation on Liability          
                           Decisions.                                   
1704              <all>   Contractor Data Security and Confidentiality  
                           Requirements.                                
                          File Specifications, Records Specifications,  
                           and Data Element Definitions for EMC Bills.  
                          Electronic Media Claims.                      
                          Requirements for Submission of EMC Data.      
                          Claims Processing Timeliness.                 
1705              <all>   Federal BL Program Address.                   
1706              <all>   Ambulance Services.                           
1707              <all>   Review of Form HCFA-1450 for Inpatient and    
                           Outpatient Bills.                            
                          EMC Flat File Record for ESRD Medical         
                           Documentation--Record Type (RT) 76.          
                          Flat File Requirements for RT 76, ESRD Medical
                           Documentation.                               
                          Provider Electronic Billing File and Record   
                           Format.                                      
                          Alphabetic Listing of Data Elements.          
                          Medical Review Attachment Data Definitions and
                           Codes.                                       
1708              <all>   Routine Services and Appliances.              
------------------------------------------------------------------------
     Carriers Manual Part 2--Program Administration (HCFA Pub. 14-2)    
             (Superintendent of Documents No. HE 22.8/7-3)              
------------------------------------------------------------------------
13                <all>   Claims Processing Timeliness.                 
                          Functional Standards for Claims Processing    
                           Operations.                                  
------------------------------------------------------------------------
 Carriers Manual Part 3--Claims Process (HCFA Pub. 14-3) (Superintendent
                       of Documents No. HE 22.8/7)                      
------------------------------------------------------------------------
1555              <all>   Reasonableness and Necessity.                 
1556              <all>   Beneficiary Address Change.                   
1557              <all>   Laboratory Tests.                             
                          Separately Billable Tests Furnished to        
                           Patients of Independent Dialysis Facilities. 
1558              <all>   Type of Service.                              
1559              <all>   Reasonableness and Necessity.                 
1560              <all>   Contractor Data Security and Confidentiality  
                           Requirements.                                
                          EMC Testing and Verification.                 
                          Data Sets and Formats for EMC and Electronic  
                           Remittance Advice.                           
                          Requirements for Processing EMC.              
                          Technical Requirements.                       
                          Requirements for Processing EMC.              
1561              <all>   Federal Black Lung Program Address.           
                          Charges by Relative or Member of Immediate    
                           Household.                                   
                          Duplicate and/or Overlapping Bills With       
                           Discrepant Charges.                          
                          Evidence of Medical Necessity for Parenteral  
                           and Enteral Nutrition.                       
                          TPP Pays Primary Benefits When Not Required.  
                          Federal Government's Right to Sue and Collect 
                           Double Damages.                              
                          Documentation of Conformance.                 
                          When Medicare Secondary Benefits are Payable. 
                          When Medicare Secondary Benefits are Not      
                           Payable.                                     
                          Calculating Medicare Secondary Payments for   
                           Services Reimbursed on Reasonable Charge or  
                           Other Basis Under Part B.                    
                          Effect of Failure to File Proper Claim.       
                          Effect of Primary Payments on Deductibles and 
                           Coinsurance.                                 
                          Right of Physician or Supplier to Charge      
                           Beneficiary.                                 
                          Charging Expenses Against Annual Limit on     
                           Incurred Expenses for Services of            
                           Independently Practicing Physical Therapist. 
                          Nondiscrimination.                            
                          Medicare Secondary Payment for Managed Care   
                           Organization Copayments.                     
                          Individuals Receiving Delayed Compensation    
                           Payments Subject to FICA Taxes.              
                          Referral to Internal Revenue Services.        
                          Primary Payer is Bankrupt or Insolvent.       

[[Page 59362]]

                                                                        
                          Determining Size of Employers.                
                          Current Employment Status.                    
                          Limitation on Payment for Services to         
                           Individuals Entitled to Benefits on the Basis
                           of ESRD Who are Covered by GHPs.             
                          Prohibition Against Taking into Account,      
                           Medicare Eligibility or Entitlement and      
                           Benefit Differentiation During Coordination  
                           Period.                                      
                          Determining Period During Which Medicare May  
                           Be Secondary Payer.                          
                          Dual Eligibility/Entitlement Situations.      
                          Effect of ESRD MSP on Consolidated Omnibus    
                           Budget Reconciliation Act Continuation       
                           Coverage.                                    
                          Medicare Secondary Payer Provision for        
                           Disabled Beneficiaries                       
                          Items and Services Furnished on or After      
                           August 10, 1993 and Before October 1, 1998.  
                          Individuals Not Subject to MSP Provision.     
                          The 100-or-More Employees Requirement.        
                          Disabled Individuals Who Return to Work.      
                          Dually-Entitled Individuals.                  
                          Items and Services Furnished on or After      
                           January 1, 1987 and Before August 10, 1993.  
                          Prohibition Against Financial and Other       
                           Incentives.                                  
                          Federal Government's Right to Sue and Collect 
                           Double Damages.                              
                          Excise Tax Penalties for Contributors to      
                           Nonconforming Group Health Plans.            
1563              <all>   Paper Remittance Notice Requirements.         
------------------------------------------------------------------------
   Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of 
                       Documents No. HE 22.8/6-5)                       
------------------------------------------------------------------------
A-97-1            <all>   Extension of Due Date for Filing Provider 2552-
                           96 Cost Reports.                             
A-97-2            <all>   Hospital Outpatient Procedures: Medicare      
                           Changes for Radiology and Other Diagnostic   
                           Coding Due to the 1997 HCPCS Update and New  
                           Dermatology HCPCS Codes.                     
A-97-3            <all>   Cost Report Filing Requirements for Hospitals 
                           with Multiple Skilled Nursing Facilities.    
------------------------------------------------------------------------
      Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B)      
              (Superintendent of Documents No. HE 22.8/6-5)             
------------------------------------------------------------------------
AB-96-12          <all>   Sterile Intravitreal Implant with Cytovene    
                           (Trade Name: Vitrasert).                     
AB-96-13          <all>   Revaccination of Beneficiaries Who Received   
                           Recalled Influenza Virus Vaccine.            
AB-97-1           <all>   New Interest Rate Payable on Clean Claims Not 
                           Paid Timely.                                 
AB-97-2           <all>   Calculation Methodology for Hematocrit Levels 
                           Used to Determine the Applicability of       
                           Payment for EPO Provided to ESRD Patients.   
AB-97-3           <all>   Binding Contractor Hearing Officers to L/RMRP.
AB-97-4           <all>   Common Working File (CWF) Crossover Edits in  
                           Release 97.1.                                
AB-97-5           <all>   New Panels Approved by CPT.                   
------------------------------------------------------------------------
       State Operations Manual Provider Certification (HCFA Pub. 7)     
              (Superintendent of Documents No. HE 22.8/12)              
------------------------------------------------------------------------
279               <all>   Model Letter to Provider (Send with Form HCFA-
                           2567) (Immediate Jeopardy Does Not Exist)    
                           Model Letter Notifying Provider Acceptance of
                           Allegation of Compliance.                    
                          Model Letter Notifying Provider of Results of 
                           Revisit.                                     
                          Notice Requirements.                          
                          Timing of CMPs.                               
                          Procedures for Recommending Enforcement       
                           Remedies When Immediate Jeopardy Does Not    
                           Exist.                                       
                          Response to Allegation of Compliance.         
                          Basis for Imposing CMPs.                      
280               <all>   Updates of Interpretive Guidelines and Survey 
                           Procedures for Hospitals.                    
------------------------------------------------------------------------
 Hospital Manual (HCFA Pub. 10) (Superintendent of Documents No. HE 22.8/
                                   2)                                   
------------------------------------------------------------------------
704               <all>   Outpatient Therapeutic Services.              
705               <all>   Pneumococcal Pneumonia Influenza Virus and    
                           Hepatitis B Vaccines.                        
706               <all>   Laboratory Tests for Hemodialysis,            
                           Intermittent Peritoneal Dialysis (IPD) and   
                           Continuous Cycling Peritoneal Dialysis (CCPD)
                           Included in Composite Rate.                  
                          Laboratory Tests for CAPD Covered Routinely   
                           and Separately Billable.                     
707               <all>   Oral Cancer Drugs.                            
                          Self-Administered Antiemetic Drugs.           
708               <all>   Billing for Hospital Outpatient Partial       
                           Hospitalization Services.                    
709               <all>   Billing for DME, Orthotic/Prosthetic Devices  
                           and Surgical Dressings.                      
710               <all>   Ambulance Service Claims.                     
711               <all>   Outpatient Therapeutic Services.              
------------------------------------------------------------------------

[[Page 59363]]

                                                                        
  Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents 
                             No. HE 22.8/5)                             
------------------------------------------------------------------------
282               <all>   Billing for Oral Cancer Drugs.                
                          Self-Administered Antiemetic Drugs.           
------------------------------------------------------------------------
  Medicare Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA 
         Pub. 29) (Superintendent of Documents No. HE 22.8/13)          
------------------------------------------------------------------------
77                <all>   Laboratory Tests for Hemodialysis, IPD and    
                           CCPD.                                        
------------------------------------------------------------------------
    Medicare Outpatient Physical Therapy and Comprehensive Outpatient   
     Rehabilitation Facility Manual (HCFA Pub. 9) (Superintendent of    
                        Documents No. HE 22.8/9)                        
------------------------------------------------------------------------
129               <all>   Billing Instructions for Partial              
                           Hospitalization Services Provided in         
                           Community Mental Health Centers.             
------------------------------------------------------------------------
     Medicare Coverage Issues Manual (HCFA Pub. 6) (Superintendent of   
                        Documents No. HE 22.8/14)                       
------------------------------------------------------------------------
91                <all>   Laboratory Tests--CRD Patients.               
92                <all>   Osteogenic Stimulation.                       
93                <all>   Treatment of Motor Function Disorders with    
                           Electric Nerve Stimulation.                  
                          Transmyocardial Revascularization With Laser--
                           Not Covered.                                 
                          Intraocular Lenses (IOL).                     
                          Partial Ventriculectomy (Also known as        
                           Ventricular Reduction, Ventricular Remodeling
                           or Heart Volume Reduction Surgery).          
                          Cryosurgery of Prostate.                      
                          Vertebral Axial Decompression (VAX-D).        
                          Infusion Pumps.                               
------------------------------------------------------------------------
     Medicare Provider Reimbursement Manual Part 1--(HCFA Pub.15-1)     
               (Superintendent of Documents No. HE 22.8/4)              
------------------------------------------------------------------------
398               <all>   Regional Medicare Swing-Bed SNF Rates.        
------------------------------------------------------------------------
   Provider Reimbursement Manual Part II--Provider Cost Reporting Forms 
 and Instructions (HCFA Pub. 15-II-AF) (Superintendent of Documents No. 
                               HE 22.8/4)                               
------------------------------------------------------------------------
3                 <all>   Home Health Agency Complex Identification     
                           Data.                                        
                          Adjustments to Expenses.                      
                          Cost Allocation--General Service Costs, and   
                          Cost Allocation--Statistical Basis.           
4                 <all>   Home Health Agency Cost Report.               
                          Home Health Agency Complex Identification     
                           Data.                                        
                          Cost Allocation--General Service Costs, and   
                          Cost Allocation--Statistical Basis.           
                          Cost Center Coding.                           
------------------------------------------------------------------------
       State Medicaid Manual--Part 3--Eligibility (HCFA Pub. 45-3)      
              (Superintendent of Documents No. HE 22.8/10)              
------------------------------------------------------------------------
67                <all>   Changes Due to Welfare Reform.                
                          Changes in SSI Definition of Disability Due to
                           Welfare Reform.                              
                          Citizenship and Alienage.                     
                          Aliens.                                       
------------------------------------------------------------------------
         State Medicaid Manual--Part 4--Services (HCFA Pub. 45-4)       
              (Superintendent of Documents No. HE 22.8/10)              
------------------------------------------------------------------------
70                <all>   Home Respiratory Care for Ventilator-Dependent
                           Individuals.                                 
                          Home and Community-Based Services--Basis,     
                           Scope, and Purpose.                          
                          Description of Waiver Participants.           
                          Definition of Services.                       
                          Safeguards--Assurances and Documentation.     
                          Evaluations--Assurances and Documentation.    
                          Cost Effectiveness--Assurances and            
                           Documentation.                               
                          Annual Report--Assurances and Documentations. 
                          Independent Assessment of the Waiver.         
                          Home and Community-Based Services--Model      
                           Waiver Request.                              
                          Home and Community-Based Services--Procedures 
                           to Request Renewal of Approved Waivers.      
                          Home and Community-Based Services--Amendments.
------------------------------------------------------------------------
   State Medicaid Manual--Part 6 Payment for Services (HCFA Pub. 45-6)  
              (Superintendent of Documents No. HE 22.8/10)              
------------------------------------------------------------------------
33                <all>   Physician Services to Children Under 21.      
                          Physician Services to Pregnant Women.         
------------------------------------------------------------------------
     Medicare/Medicaid Sanction--Reinstatement Report (HCFA Pub. 69)    
------------------------------------------------------------------------
97-1              <all>   Report of Physicians/Practitioners, Providers 
                           and/or Other Health Care Suppliers Excluded/ 
                           Reinstated--December 1996.                   

[[Page 59364]]

                                                                        
97-2              <all>   Cumulative Report of Physicians/Practitioners,
                           Providers and/or Other Health Care Suppliers 
                           Sanctioned/Reinstated.                       
97-3              <all>   Report of Physicians/Practitioners, Providers 
                           and/or Other Health Care Suppliers Excluded/ 
                           Reinstated--January 1997.                    
97-4              <all>   Report of Physicians/Practitioners, Providers 
                           and/or Other Health Care Suppliers Excluded/ 
                           Reinstated--February 1997.                   
------------------------------------------------------------------------


                                          Addendum IV.--Regulation Documents Published in the Federal Register                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                   End of               
        Publication date            FR vol. 61       CFR                File code*                     Regulation title           comment     Effective 
                                       page        part(s)                                                                         period        date   
--------------------------------------------------------------------------------------------------------------------------------------------------------
01/02/97........................     26-31              413  BPD-788-F                         Medicare Program; Electronic     ...........     02/01/97
                                                                                                Cost Reporting for Skilled                              
                                                                                                Nursing Facilities and Home                             
                                                                                                Health Agencies.                                        
01/13/97........................  1682-1685             435  MB-105-FC                         Medicaid Program;                   03/14/97     01/13/97
                                                                                                Redeterminations of Medicaid                            
                                                                                                Eligibility Due to Welfare                              
                                                                                                Reform.                                                 
01/13/97........................  1768-1776       .........  BPD-882-N                         Notification Procedures for      ...........  ...........
                                                                                                States Implementing                                     
                                                                                                ``Alternative Mechanisms'' in                           
                                                                                                the Individual Health                                   
                                                                                                Insurance Market.                                       
01/16/97........................  2373-2374       .........  ORD-095-N                         New and Pending Demonstration    ...........  ...........
                                                                                                Project Proposals Submitted                             
                                                                                                Pursuant to Section 1115(a) of                          
                                                                                                the Social Security Act:                                
                                                                                                November 1996.                                          
01/23/97........................      3563        .........  BPD-886-N                         Department of Health and Human   ...........  ...........
                                                                                                Services, Health Care                                   
                                                                                                Financing Administration;                               
                                                                                                Department of Labor, Pension                            
                                                                                                and Welfare Benefits                                    
                                                                                                Administration; and Department                          
                                                                                                of the Treasury, Office of Tax                          
                                                                                                Policy and Internal Revenue                             
                                                                                                Service  (the Agencies );                               
                                                                                                Health Insurance Portability;                           
                                                                                                Correction.                                             
01/29/97........................  4305-4311       .........  ORD-089-N                         Medicare and Medicaid Programs;  ...........  ...........
                                                                                                Small Business Innovation                               
                                                                                                Research Grants for Fiscal                              
                                                                                                Year 1997.                                              
01/31/97........................  4772-4776       .........  MB-104-N                          Medicaid Program; Preliminary    ...........  ...........
                                                                                                Limitations on Aggregate                                
                                                                                                Payments to Disproportionate                            
                                                                                                Share Hospitals: Federal                                
                                                                                                Fiscal Year 1997.                                       
02/05/97........................  5433-5442       .........  HSQ-244-N                         CLIA Program; Clinical           ...........     10/28/96
                                                                                                Laboratory Improvement                                  
                                                                                                Amendments of 1988--Denial of                           
                                                                                                Exemption of Laboratories in                            
                                                                                                the Commonwealth of Puerto                              
                                                                                                Rico.                                                   
02/21/97........................  7945-7946             410  BPD-852-CN                        Medicare Program; Revisions to   ...........     01/01/97
                                                        415                                     Payment Policies and Five-Year                          
                                                                                                Review of and Adjustments to                            
                                                                                                the Relative Value Units Under                          
                                                                                                the Physician Fee Schedule for                          
                                                                                                Calendar Year 1997; Correction.                         
02/25/97........................  8451-8452       .........  ORD-096-N                         New and Pending Demonstration    ...........  ...........
                                                                                                Project Proposals Submitted                             
                                                                                                Pursuant to Section 1115(a) of                          
                                                                                                the Social Security Act:                                
                                                                                                December 1996.                                          
03/06/97........................     10286        .........  OPL-014-N                         Medicare Program; March 24,      ...........  ...........
                                                                                                1997 Meeting of the Practicing                          
                                                                                                Physicians Advisory Council.                            
03/10/97........................  11035-11064           484  HSQ-238-P                         Medicare and Medicaid Programs;     06/09/97  ...........
                                                                                                Use of the OASIS as Part of                             
                                                                                                the Conditions of                                       
                                                                                                Participation for Home Health                           
                                                                                                Agencies.                                               
03/10/97........................  11005-11035           484  BPD-819-P                         Medicare and Medicaid Programs;     06/09/97  ...........
                                                                                                Conditions of Participation                             
                                                                                                for Home Health Agencies.                               
03/28/97........................  14851-14878           413  BPD-808-P                         Medicare and Medicaid Programs;     05/27/97  ...........
                                                                                                Salary Equivalency Guidelines                           
                                                                                                for Physical Therapy,                                   
                                                                                                Respiratory Therapy, Speech                             
                                                                                                Language Pathology, and                                 
                                                                                                Occupational Therapy Services.                          
03/31/97........................  15187-15191     .........  ORD-097-N                         New and Pending Demonstration    ...........  ...........
                                                                                                Project Proposals Submitted                             
                                                                                                Pursuant to Section 1115(a) of                          
                                                                                                the Social Security Act:                                
                                                                                                January 1997 and Supplement to                          
                                                                                                December 1996 Listing.                                  
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 59365]]

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

    Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices 
fall into one of three classes. Also, under the new categorization 
process to assist HCFA, the Food and Drug Administration assigns each 
device with a Food and Drug Administration-approved investigational 
device exemption to one of two categories. To obtain more information 
about the classes or categories, please refer to the Federal Register 
notice published on April 21, 1997 (62 FR 19328).
    The following information presents the device number, category (in 
this case, A), and criterion code.

G960213  A2
G960218  A1
G960258  A1
G960266  A1
G970004  A1
G970007  A1
G970015  A2
G970016  A2
G970018  A2
G970022  A2
G970035  A2
G970051  A2
G970053  A2

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

G950115  B1
G956391  B2
G960193  B4
G960199  B2
G960208  B1
G960229  B1
G960230  B2
G960231  B3
G960234  B4
G960235  B3
G960241  B2
G960243  B2
G960245  B2
G960246  B1
G960247  B1
G960248  B4
G960249  B4
G960250  B3
G960252  B2
G960253  B4
G960254  B2
G960255  B2
G960256  B1
G960257  B3
G960259  B4
G960262  B3
G960263  B3
G960264  B3
G960267  B1
G970001  B3
G970002  B4
G970003  B3
G970005  B4
G970011  B2
G970012  B4
G970019  B3
G970023  B4
G970025  B3
G970026  B3
G970028  B3
G970029  B3
G970030  B1
G970031  B3
G970032  B3
G970033  B4
G970034  B4
G970037  B4
G970038  B4
G970039  B4
G970040  B3
G970041  B4
G970046  B1
G970047  B3
G970052  B1
G970054  B4
G970059  B3

[FR Doc. 97-28972 Filed 10-31-97; 8:45 am]
BILLING CODE 4120-03-P