[Federal Register Volume 63, Number 107 (Thursday, June 4, 1998)]
[Notices]
[Pages 30499-30506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-9152-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--Third 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 July, August, and September 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 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.

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).
Pamela Gulliver, (410) 786-4659 (For all other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs, which pay for health 
care and related services for 38 million Medicare beneficiaries and 36 
million Medicaid recipients. Administration of these programs involves 
(1) providing information to Medicare beneficiaries and Medicaid 
recipients, health care providers, and the public, and (2) effective 
communications with regional offices, State governments, State Medicaid 
Agencies, State Survey Agencies, various providers of health care, 
fiscal intermediaries and carriers that process claims and pay bills, 
and others. To implement the various statutes on which the programs are 
based, we issue regulations under the authority granted the Secretary 
under sections 1102, 1871, and 1902 and related provisions of the 
Social Security Act (the Act) and also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish in the 
Federal Register at least every 3 months a list of all Medicare manual 
instructions, interpretive rules, and guidelines of general 
applicability not issued as regulations. We published our first notice 
June 9, 1988 (53 FR 21730). Although we are not mandated to do so by 
statute, for the sake of completeness of the listing of operational and 
policy statements, we are continuing our practice of including Medicare 
substantive and interpretive regulations (proposed and final) published 
during the 3-month time frame. Since the publication of our quarterly 
listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid 
issuances to our quarterly listings. Accordingly, we list in this 
notice Medicaid issuances and Medicaid substantive and interpretive 
regulations published during July through September 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 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 five addenda. Addendum I lists the publication dates of 
the most recent quarterly listings of program issuances.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. Often it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
    Addendum IV lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice. For each item, we 
list the date published, the Federal Register citation, the parts of 
the Code of Federal Regulations (CFR) that have changed (if 
applicable), the agency file code number, the title of the regulation, 
the ending date of the comment period (if applicable), and the 
effective date (if applicable).
    On September 19, 1995, we published a final rule (60 FR 48417) 
establishing in regulations at 42 CFR 405.201 et seq. that certain 
devices with an investigational device exemption approved by the Food 
and Drug Administration and certain services related to those devices 
may be covered under Medicare. It is HCFA's practice to announce in 
this quarterly notice all investigational device exemption 
categorizations, using the investigational device exemption numbers the 
Food and Drug Administration assigns. Addendum V includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved or revised during the quarter 
covered by

[[Page 30500]]

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

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

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both text and graphics from Volume 59, Number 1 (January 2, 1994) 
forward. Free public access is available on a Wide Area Information 
Server (WAIS) through the Internet and via asynchronous dial-in. 
Internet users can access the database by using the World Wide Web; the 
Superintendent of Documents home page address is http://
www.access.gpo.gov/su__docs/, by using local WAIS client software, or 
by telnet to swais.access.gpo.gov, then log in as guest (no password 
required). Dial-in users should use communications software and modem 
to call (202) 512-1661; type swais, then log in as guest (no password 
required).

C. Rulings

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

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

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

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 Home Health Agency Manual, 
(HCFA Pub. 11) transmittal entitled ``Billing for Durable Medical 
Equipment, Orthotic/Prosthetic Devices,'' use the Superintendent of 
Documents No. HE 22.8/5 and the HCFA transmittal number 283.

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 
Pamela Gulliver, Office of Communications and

[[Page 30501]]

Operations Support, Division of Regulations and Issuances, Health Care 
Financing Administration, C5-09-26, 7500 Security Boulevard, Baltimore, 
MD 21244-1850, Telephone (410) 786-4659.

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

    Dated: May 5, 1998.
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.

December 18, 1996 (61 FR 66676)
April 21, 1997 (62 FR 19328)
May 12, 1997 (62 FR 25957)
November 3, 1997 (62 FR 59358)
November 21, 1997 (62 FR 62325)

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 1997 
Through September 1997

------------------------------------------------------------------------
           Trans.                   Manual/Subject/Publication No,      
------------------------------------------------------------------------
                           Intermediary Manual                          
                      Part 1--Fiscal Administration                     
                            (HCFA Pub. 13-1)                            
             (Superintendent of Documents No. HE 22.8/6-3)              
------------------------------------------------------------------------
128.........................   Coordination of Medicare and     
                               Complementary Insurance Programs.        
                              Coordination of Medicare With the Federal 
                               Grants in Aid Program (Medicaid).        
------------------------------------------------------------------------
                           Intermediary Manual                          
                         Part 3--Claims Process                         
                            (HCFA Pub. 13-3)                            
              (Superintendent of Documents No. HE 22.8/6)               
------------------------------------------------------------------------
1715........................   Self-Administered Drug           
                               Administered In An Emergency Situation.  
1716........................   Mammography Screening.           
1717........................   HCPCS for Hospital Outpatient    
                               Radiology Services and Other Diagnostic  
                               Procedures.                              
1718........................   Billing for Durable Medical      
                               Equipment, Orthotic/Prosthetic Devices   
                               and Surgical Dressings.                  
1719........................   CFA Common Procedure Coding      
                               System.                                  
1720........................   Completing Quarterly Report on   
                               Provider Enrollment.                     
1721........................   Laboratory Tests for             
                               Hemodialysis, Intermittent Peritoneal    
                               Dialysis, Continuous Cycling Peritoneal  
                               Dialysis and Hemofiltration.             
                              Laboratory Tests.                         
1722........................   HCPCS Codes for Diagnostic       
                               Services and Medical Services (Correction
                               to Transmittal Number 1719, dated July   
                               1997).                                   
1723........................   Claims Processing Timeliness.    
1724........................   HCPCS Codes for Diagnostic       
                               Services and Medical Services--Correction
                               to Transmittal Number 1722, Dated August 
                               1997.                                    
1725........................   Mammography Screening.           
                              Focused Medical Review.                   
                              Focused Medical Review Activity Report.   
1726........................   Review of Form HCFA-1450 for     
                               Inpatient and Outpatient Bills.          
                              Provider Electronic Billing File and      
                               Record Formats.                          
                              Alphabetic Listing of Data Elements.      
------------------------------------------------------------------------
                          Intermediary Manual.                          
                        Part 4--Audit Procedures                        
                            (HCFA Pub. 13-4)                            
             (Superintendent of Documents No. HE 22.8/6-4)              
------------------------------------------------------------------------
33..........................   Home Office Uniform Desk Review. 
------------------------------------------------------------------------
                             Carriers Manual                            
             Part 1--Fiscal Administration (HCFA Pub. 14-1)             
             (Superintendent of Documents No. HE 22.8/7-2)              
------------------------------------------------------------------------
122.........................   Coordination of Medicare and     
                               Complementary Insurance Programs.        
                               Coordination of Medicare With the
                               Federal Grants in Aid Program (Medicaid).
------------------------------------------------------------------------
                             Carriers Manual                            
                 Part 2--Claims Process (HCFA Pub. 14-2)                
             (Superintendent of Documents No. HE 22.8/7-3)              
------------------------------------------------------------------------
136.........................   Functional Standards for Claims  
                               Processing Operations.                   
------------------------------------------------------------------------

[[Page 30502]]

                                                                        
                             Carriers Manual                            
                         Part 3--Claims Process                         
                            (HCFA Pub. 14-3)                            
              (Superintendent of Documents No. HE 22.8/7)               
------------------------------------------------------------------------
1573........................   Evidence of Medical Necessity for
                               Durable Medical Equipment.               
                              General Claims Processing Requirements.   
                              Billing Requirements.                     
                              Simplified Roster Bills.                  
                              Health Insurance Maintenance Organization 
                               Processing Requirements.                 
                              Speciality Code/Place of Service          
                               Processing Requirements.                 
                              Suppression of EOMBs.                     
                              Billing Requirements for Global Surgeries.
                              Claims Review for Global Surgeries.       
                              Payment for Return Trips to the Operating 
                               Room for Treatment of Complications.     
                              EOMB and Remittance Messages.             
                              Payment for Eyeglasses, Contact Lenses,   
                               and Related Services.                    
                              Interpretation of Diagnostic Tests.       
1574........................   Identifying a Screening          
                               Mammography Claim.                       
1575........................   Claims Processing Terminology.   
                              Handling Incomplete or Invalid Claims.    
                              Conditional Data Element Requirements.    
                              Data Element Requirements Matrix.         
                              Data Element Requirements.                
                              Incomplete or Invalid Claims.             
1576........................   Exception to Sec.  7560 A and B  
                               When Physician, Other Practitioner, or   
                               Supplier Is Excluded From Participation  
                               in Medicare Program.                     
                              Authority to Exclude Practitioners,       
                               Providers, and Suppliers of Services.    
1577........................   Evidence of Medicaid Necessity   
                               for Durable Medical Equipment (Correction
                               to Transmittal Number 1573, dated July   
                               1997).                                   
1578........................   Assistant at Surgery Services.   
                              Purchased Diagnostic Tests.               
                              Inpatient Dialysis On Same Date As        
                               Evaluation and Management.               
                              Consultations.                            
                              Threshold Times For Codes 99354 and 99355.
1579........................   Services Eligible for HPSA Bonus 
                               Payments.                                
                              Remittance Messages.                      
1580........................   Doctor of Medicine and           
                               Osteopathy.                              
------------------------------------------------------------------------
                             Carriers Manual                            
                     Part 4--Professional Relations                     
                            (HCFA Pub. 14-4)                            
             (Superintendent of Documents No. HE 22.8/7-4)              
------------------------------------------------------------------------
14..........................   Patient and Insured Information. 
                              Provider of Service or Supplier           
                               Information.                             
                              Place of Service Codes and Definitions.   
------------------------------------------------------------------------
                           Program Memorandum                           
                     Intermediaries (HCFA Pub. 60A)                     
             (Superintendent of Documents No. HE 22.8/6-5)              
------------------------------------------------------------------------
A-97-5......................   Application of Medicare          
                               Reasonable Cost Reimbursement Principles 
                               to Rural Health Clinics.                 
A-97-6......................   Extension of Due Date for Filing 
                               Form HCFA-2540-96 and Form HCFA-1728-94  
                               Cost Reports.                            
A-97-7......................   Home Health Agency Requests to   
                               Intermediaries to Change Cost Center     
                               Allocation Sequence or Statistical       
                               Allocation Basis.                        
A-97-8......................   Instructions to Implement the New
                               Medicare Summary Notice.                 
A-97-9......................   Hospital Outpatient Procedures:  
                               Medicare Changes Due to 1997 HCPCS       
                               Update--New Dermatology Codes            
                               (Clarification).                         
A-97-10.....................   Change in Hospice Payment Rates. 
A-97-11.....................   Hospice Provisions Enacted by the
                               Balanced Budget Act of 1997.             
A-97-12.....................   Medicare Home Health Benefit--The
                               Balanced Budget Act of 1997 Clarification
                               of Part-Time or Intermittent Skilled     
                               Nursing Care.                            
A-97-13.....................   FY 1998 Prospective Payment      
                               System, TEFRA Hospital and Other Bill    
                               Processing Changes.                      
A-97-14.....................   Hospital Outpatient Procedures:  
                               Billing for Contrast Material            
                               (Clarification).                         
------------------------------------------------------------------------
                           Program Memorandum                           
                                Carriers                                
                             (HCFA Pub. 60B)                            
             (Superintendent of Documents No. HE 22.8/6-5)              
------------------------------------------------------------------------
B-97-2......................   Changes to Correct Coding Edits, 
                               Version 4.0.                             
B-97-3......................   Instructions for CLIA Compliance 
                               for Part B Laboratory Claims Submitted to
                               Carriers.                                
B-97-4......................   Instructions for CLIA Compliance 
                               for Part B Laboratory Claims Submitted to
                               Carriers-- Correction to Transmittal     
                               Number B-97-3, dated September 1997.     
B-97-5......................   Update of Rates and Wage Index   
                               for Ambulatory Surgical Center Payments  
                               Effective October 1, 1997.               
------------------------------------------------------------------------

[[Page 30503]]

                                                                        
                           Program Memorandum                           
                         Intermediaries/Carriers                        
                            (HCFA Pub. 60A/B)                           
             (Superintendent of Documents No. HE 22.8/6-5)              
------------------------------------------------------------------------
AB-97-10....................   Claims for Separately Billable   
                               End Stage Renal Disease Laboratory       
                               Services Performed by Certified          
                               Independent Dialysis Facilities.         
AB-97-11....................   Counting of Non-Medicare Home    
                               Health Visits and the Reporting of the   
                               Associated Costs in Determining the      
                               Average Cost Per Visit for Home Health   
                               Services.                                
AB-97-12....................   New Implementation Date for      
                               Hematocrit Levels for Erythropoietin.    
AB-97-13....................   Extension of the Limitation on   
                               Payment for Services to Individuals      
                               Entitled to Benefits on the Basis of End 
                               Stage Renal Disease Who are Covered by   
                               Group Health Plans.                      
AB-97-14....................   Extension of the Limitation on   
                               Payment for Services to Individuals      
                               Entitled to Benefits on the Basis of End 
                               Stage Renal Disease Who are Covered by   
                               Group Health Plans (GHP)-- Correction to 
                               Program Memorandum Number AB-97-13, dated
                               September 1997.                          
AB-97-15....................   Update to the Hospice Wage Index.
AB-97-16....................   Balanced Budget Act of 1997, P.L.
                               105-33 (H.R. 2015)--Home Health Payment  
                               Provisions.                              
AB-97-17....................   New Panels Approved by Common    
                               Procedural Terminology--Clarification of 
                               Program Memorandum AB-97-5.              
AB-97-18....................   Balanced Budget Act of 1997, P.L.
                               105-33 (H.R.)-Home Health Payment        
                               Provisions.                              
------------------------------------------------------------------------
                         State Operations Manual                        
                         Provider Certification                         
                              (HCFA Pub. 7)                             
              (Superintendent of Documents No. HE 22.8/12)              
------------------------------------------------------------------------
283.........................   Interpretive Guidelines and      
                               Survey Procedures.                       
------------------------------------------------------------------------
                     Peer Review Organization Manual                    
                             (HCFA Pub. 19)                             
             (Superintendent of Documents No. HE 22.8/8-15)             
------------------------------------------------------------------------
64..........................   Opportunity to Discuss.          
                              Authority.                                
                              Scope of Review.                          
                              Complaints That Do Not Meet Statutory     
                               Requirements.                            
                              Referrals.                                
                              Review Process.                           
------------------------------------------------------------------------
                             Hospital Manual                            
                             (HCFA Pub. 10)                             
              (Superintendent of Documents No. HE 22.8/2)               
------------------------------------------------------------------------
716.........................   Self-Administered Drug           
                               Administered In An Emergency Situation.  
717.........................   Billing for Mammography          
                               Screening.                               
718.........................   HCPCS for Hospital Outpatient    
                               Radiology Services and Other Diagnostic  
                               Procedures.                              
719.........................   Billing for Durable Medical      
                               Equipment, Orthotic/Prosthetic Devices,  
                               and Surgical Dressings.                  
720.........................   HCFA Common Procedure Coding     
                               System.                                  
721.........................   HCPCS Codes for Diagnostic       
                               Services and Medical Services.           
722.........................   Billing for Mammography          
                               Screening.                               
------------------------------------------------------------------------
                        Home Health Agency Manual                       
                             (HCFA Pub. 11)                             
              (Superintendent of Documents No. HE 22.8/5)               
------------------------------------------------------------------------
283.........................   Billing for Durable Medical      
                               Equipment, Orthotic/Prosthetic Devices.  
------------------------------------------------------------------------
                     Skilled Nursing Facility Manual                    
                             (HCFA Pub. 12)                             
              (Superintendent of Documents No. HE 22.8/3)               
------------------------------------------------------------------------
348.........................   Billing for Mammography          
                               Screening.                               
349.........................   Billing for Durable Medical      
                               Equipment (DME), Orthotic/Prosthetic     
                               Devices, and Surgical Dressings.         
350.........................   Billing for Mammography          
                               Screening.                               
------------------------------------------------------------------------
 Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation
                             Facility Manual                            
                              (HCFA Pub. 9)                             
              (Superintendent of Documents No. HE 22.8/9)               
------------------------------------------------------------------------
130.........................   Billing for Durable Medical      
                               Equipment Orthotic/Prosthetic Devices,   
                               and Surgical Dressings.                  
------------------------------------------------------------------------
                         Coverage Issues Manual                         
                              (HCFA Pub. 6)                             
              (Superintendent of Documents No. HE 22.8/18)              
------------------------------------------------------------------------
102.........................   Hyperbaric Oxygen Therapy        

[[Page 30504]]

                                                                        
                              Lung Volume Reduction Surgery (Reduction  
                               Pneumoplasty, Also Called Lung Shaving or
                               Lung Contouring) Unilateral or Bilateral 
                               by Open or Thoracoscopic Approach for    
                               Treatment of Emphysema or Chronic        
                               Obstructive Pulmonary Disease.           
------------------------------------------------------------------------
                  Provider Reimbursement Manual--Part 1                 
                            (HCFA Pub. 15-1)                            
                (Superintendent of Documents No. 22.8/4)                
------------------------------------------------------------------------
400.........................   Provider Requests Regarding      
                               Applicability of Cost Limits.            
                              Request for Exemption From Skilled Nursing
                               Facility Cost Limits.                    
------------------------------------------------------------------------
                  Provider Reimbursement Manual--Part I                 
       Chapter 27--Reimbursement for ESRD and Transplant Services       
                           (HCFA Pub. 15-1-27)                          
                (Superintendent of Documents No. 22.8/4)                
------------------------------------------------------------------------
29..........................   Allowable Compensation for       
                               Physician Owners and Medical Directors   
                              Allowable Compensation for Owners,        
                               Administrators, and Assistant            
                               Administrators.                          
                              Submission of Documentation.              
------------------------------------------------------------------------
                 Provider Reimbursement Manual--Part II                 
             Provider Cost Reporting Forms and Instructions             
                           (HCFA Pub. 15-II-A)                          
                (Superintendent of Documents No. 22.8/4)                
------------------------------------------------------------------------
19..........................   Electronic Submission of Cost    
                               Reports.                                 
                              Electronic Submission of Hospital Cost    
                               Reports.                                 
                              Electronic Submission of SNF and HHA Cost 
                               Reports.                                 
                 Provider Reimbursement Manual--Part II                 
             Provider Cost Reporting Forms and Instructions             
                           (HCFA Pub. 15-II-A)                          
                (Superintendent of Documents No. 22.8/4)                
------------------------------------------------------------------------
3...........................   Hospital and Hospital Health Care
                               Complex Cost Report, Form HCFA-2552-96.  
------------------------------------------------------------------------
                      State Medicaid Manual--Part 2                     
              State Organization and General Administration             
                            (HCFA Pub. 45-2)                            
              (Superintendent of Documents No. HE22.8/10)               
------------------------------------------------------------------------
89..........................   Statistical Report on Medical    
                               Care: Eligibles, Recipients, Payments,   
                               and Services (Form HCFA-2082).           
                              Requirements for State Participation in   
                               the Medicaid Statistical Information     
                               System.                                  
------------------------------------------------------------------------
                      State Medicaid Manual--Part 3                     
                               Eligibility                              
                            (HCFA Pub. 45-3)                            
              (Superintendent of Documents No. HE22.8/10)               
------------------------------------------------------------------------
68..........................   Retroactive Medicaid Coverage.   
------------------------------------------------------------------------
                      State Medicaid Manual--Part 6                     
                          Payment for Services                          
                            (HCFA Pub. 45-6)                            
              (Superintendent of Documents No. HE22.8/10)               
------------------------------------------------------------------------
34..........................   Ingredient Prices Used by States 
                               to Establish Upper Limits for            
                               Prescription Drugs.                      
------------------------------------------------------------------------
                Rural Health Clinic Manual and Federally                
                     Qualified Health Centers Manual                    
                             (HCFA Pub. 27)                             
            (Superintendent of Documents No. HE22.8/19:985)             
------------------------------------------------------------------------
27..........................   Billing for Mammography Screening
                               by Rural Health Clinics and Federally    
                               Qualified Health Centers.                
28..........................   Billing for Mammography Screening
                               by Rural Health Clinics and Federally    
                               Qualified Health Centers.                
------------------------------------------------------------------------
                           Program Memorandum                           
                          State Survey Agencies                         
                             (HCFA Pub. 65)                             
------------------------------------------------------------------------
97-1........................   Policy Clarification: Home Health
                               Agency Parent, Branch, and Subunit       
                               Criteria.                                
------------------------------------------------------------------------
                            Medicare/Medicaid                           
                     Sanction--Reinstatement Report                     
                             (HCFA Pub. 69)                             
------------------------------------------------------------------------
97-7........................   Report of Physicians/            
                               Practitioners, Providers and/or Other    
                               Health Care Suppliers Excluded/          
                               Reinstated--May 1997.                    

[[Page 30505]]

                                                                        
97-8........................   Report of Physicians/            
                               Practitioners, Providers and/or Other    
                               Health Care Suppliers Excluded/          
                               Reinstated--June 1997.                   
97-9........................   Report of Physicians/            
                               Practitioners, Providers and/or Other    
                               Health Care Suppliers Excluded/          
                               Reinstated--July 1997.                   
97-10.......................   Report of Physicians/            
                               Practitioners, Providers and/or Other    
                               Health Care Suppliers Excluded/          
                               Reinstated--August 1997.                 
------------------------------------------------------------------------


                      Addendum IV.--Regulation Documents Published in the Federal Register                      
----------------------------------------------------------------------------------------------------------------
                                                                                           End of               
Publication date  FR Vol. 62,  CFR part(s)       File code*         Regulation title      comment     Effective 
                      page                                                                 period        date   
----------------------------------------------------------------------------------------------------------------
07/01/97........  35513-35516  ...........  HSQ-243-N...........  Medicare, Medicaid,   ...........     07/01/97
                                                                   and CLIA Programs;                           
                                                                   Clinical Laboratory                          
                                                                   Improvement                                  
                                                                   Amendments of 1988                           
                                                                   Continuance of                               
                                                                   Exemption of                                 
                                                                   Laboratories                                 
                                                                   Licensed by the                              
                                                                   State of Washington.                         
07/01/97........  35608-35634  ...........  BPD-889-NC..........  Medicare Program;        09/02/97     07/01/97
                                                                   Schedule of Limits                           
                                                                   on Home Health                               
                                                                   Agency Costs Per                             
                                                                   Visit for Cost                               
                                                                   Reporting Periods                            
                                                                   Beginning on or                              
                                                                   After July 1, 1997.                          
07/02/97........  35824-35826  ...........  HSQ-207-NC..........  Medicare Program;        09/02/97     07/02/97
                                                                   Description of the                           
                                                                   Health Care                                  
                                                                   Financing                                    
                                                                   Administration's                             
                                                                   Evaluation                                   
                                                                   Methodology for the                          
                                                                   Peer Review                                  
                                                                   Organization 5th                             
                                                                   Scope of Work                                
                                                                   Contracts.                                   
07/16/97........  38100-38107  ...........  BPD-845-PN..........  Medicare Program;        09/15/97     07/16/97
                                                                   Special Payment                              
                                                                   Limits for Home                              
                                                                   Oxygen.                                      
07/17/97........  38314-38315  ...........  ORD-101-N...........  New and Pending       ...........     07/17/97
                                                                   Demonstration                                
                                                                   Project Proposals                            
                                                                   Submitted Pursuant                           
                                                                   to Section 1115(a)                           
                                                                   of the Social                                
                                                                   Security Act: May                            
                                                                   1997.                                        
07/29/97........        40568  ...........  BPD-889-NC..........  Medicare Program;     ...........     07/01/97
                                                                   Schedule of Limits                           
                                                                   on Home Health                               
                                                                   Agency Costs Per                             
                                                                   Visit for Cost                               
                                                                   Reporting Periods                            
                                                                   Beginning on or                              
                                                                   After July 1, 1997;                          
                                                                   CORRECTION.                                  
08/08/97........  42860-42883          418  BPD-820-F...........  Medicare Program;     ...........     10/01/97
                                                                   Hospice Wage Index.                          
08/14/97........  43541-43542  ...........  ORD-102-N...........  New and Pending       ...........     08/14/97
                                                                   Demonstration                                
                                                                   Project Proposals                            
                                                                   Submitted Pursuant                           
                                                                   to Section 1115(a)                           
                                                                   of the Social                                
                                                                   Security Act: June                           
                                                                   1997.                                        
08/15/97........  43657-43674  412 413 414  BPD-763-F...........  Medicare Program;     ...........     08/15/97
                                                                   End-Stage Renal                              
                                                                   Disease (ESRD)                               
                                                                   Payment Exception                            
                                                                   Requests and Organ                           
                                                                   Procurement Costs.                           
08/18/97........  43962-43963  400 405 410  BPD-884-CN..........  Medicare Program;     ...........  ...........
                                       414                         Revisions to                                 
                                                                   Payment Policies                             
                                                                   Under the Physician                          
                                                                   Fee Schedule, Other                          
                                                                   Part B Payment                               
                                                                   Policies, and                                
                                                                   Establishment of                             
                                                                   the Clinical                                 
                                                                   Psychologist Fee                             
                                                                   Schedule for                                 
                                                                   Calendar Year 1998;                          
                                                                   CORRECTION.                                  
08/18/97........  43931-43937  431 442 488  HSQ-139-F...........  Medicare and          ...........     09/17/97
                                   489 498                         Medicaid Programs;                           
                                                                   Effective Dates of                           
                                                                   Provider Agreements                          
                                                                   and Supplier                                 
                                                                   Approvals.                                   
08/20/97........        44221          488  HSQ-156-CN..........  Medicare and          ...........     07/01/95
                                                                   Medicaid Programs;                           
                                                                   Survey,                                      
                                                                   Certification and                            
                                                                   Enforcement of                               
                                                                   Skilled Nursing                              
                                                                   Facilities and                               
                                                                   Nursing Facilities.                          
08/29/97........  45815-45821  ...........  HSQ-219-GNC.........  CLIA Program; Fee        10/28/97     01/01/98
                                                                   Schedule Revision.                           
08/29/97........        45823  ...........  OPL-016-N...........  Medicare Program;     ...........  ...........
                                                                   September 22, 1997,                          
                                                                   Meeting of the                               
                                                                   Practicing                                   
                                                                   Physician Ad visory                          
                                                                   Council.                                     
08/29/97........  45966-46140  400 409 410  BPD-878-FC..........  Medicare Program;        10/28/97     10/01/97
                               411 412 413                         Changes to the                               
                               424 440 485                         Hospital Inpatient                           
                               488 489 498                         Prospective Payment                          
                                                                   Systems and Fiscal                           
                                                                   Year 1998 Rates.                             
09/04/97........  46698-46707          416  BPD-831-P...........  Medicare Program;        11/03/97     09/04/97
                                                                   Adjustment in                                
                                                                   Payment Amounts for                          
                                                                   New Technology                               
                                                                   Intraocular Lenses.                          
09/08/97........        47237          416  BPD-878-FC..........  Medicare Program;                             
                                                                   Changes to the                               
                                                                   Hospital Inpatient                           
                                                                   Prospective Payment                          
                                                                   Systems and Fiscal                           
                                                                   Year 1998 Rates;                             
                                                                   CORRECTION.                                  
09/11/97........  47896-47903          440  MB-071-F............  Medicaid Program;     ...........     11/10/97
                                                                   Coverage of                                  
                                                                   Personal Care                                
                                                                   Services.                                    
09/12/97........  48098-48105  ...........  MB-115-N............  State Children's      ...........  ...........
                                                                   Health Insurance                             
                                                                   Program; Reserved                            
                                                                   Allotments to                                
                                                                   States for Fiscal                            
                                                                   Year 1998; Enhanced                          
                                                                   Federal Medical                              
                                                                   Assistance                                   
                                                                   Percentages.                                 
09/15/97........  48292-48297  ...........  MB-110-N............  Medicaid Program;     ...........  ...........
                                                                   Final Limitations                            
                                                                   on Aggregate                                 
                                                                   Payments to                                  
                                                                   Disproportionate                             
                                                                   Share Hospitals:                             
                                                                   Federal Fiscal Year                          
                                                                   1997.                                        

[[Page 30506]]

                                                                                                                
09/17/97........  48872-48873  ...........  BPD-898-NC..........  Medicare and             11/17/97  ...........
                                                                   Medicaid Programs;                           
                                                                   Announcement of                              
                                                                   Additional                                   
                                                                   Applications From                            
                                                                   Hospitals                                    
                                                                   Requesting Waivers                           
                                                                   for Organ                                    
                                                                   Procurement Service                          
                                                                   Area.                                        
09/18/97........        49049  400 409 410  BPD-878-FC..........  Medicare Program;     ...........  ...........
                               411 412 413                         Changes to the                               
                               424 440 485                         Hospital Inpatient                           
                               488 489 498                         Prospective Payment                          
                                                                   Systems and Fiscal                           
                                                                   Year 1998 Rates;                             
                                                                   CORRECTION.                                  
09/23/97........  49649-49654  ...........  OMC-029-N...........  Medicare Program;        10/08/97  ...........
                                                                   Solvency Standards                           
                                                                   for Provider-                                
                                                                   Sponsored                                    
                                                                   Organizations;                               
                                                                   Intent To Form                               
                                                                   Negotiated                                   
                                                                   Rulemaking                                   
                                                                   Committee.                                   
09/23/97........        49726          440  MB-071-F............  Medicaid Program;     ...........  ...........
                                                                   Coverage of                                  
                                                                   Personal Care                                
                                                                   Services;                                    
                                                                   CORRECTION.                                  
09/24/97........  49937-49938          473  BPD-453-CN..........  Medicare Program;     ...........     06/11/97
                                                                   Medicare Appeals of                          
                                                                   Individual Claims;                           
                                                                   CORRECTION.                                  
----------------------------------------------------------------------------------------------------------------

Categorization of Food and Drug Administration-Approved Investigational 
Device Exemptions

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

G960082  A1
G970008  A4
G970044  A2
G970058  A2
G970069  A2
G970073  A2
G970088  A2
G970118  A2
G970121  A2
G970128  A1
G970131  A1
G970136  A2
G970147  A1
G970151  A2
G970169  A2
G970176  A2

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

G910187  B1
G960161  B4
G970014  B2
G970015  B4
G970024  B4
G970045  B4
G970081  B4
G970094  B3
G970096  B1
G970112  B2
G970116  B1
G970117  B4
G970122  B4
G970123  B4
G970129  B2
G970132  B3
G970133  B3
G970134  B4
G970135  B4
G970137  B4
G970138  B4
G970140  B1
G970141  B2
G970142  B1
G970149  B3
G970150  B1
G970157  B4
G970161  B4
G970168  B1
G970178  B2
G970179  B2
G970180  B4
G970183  B1
G970189  B4
G970191  B1
G970193  B2
G970194  B2

[FR Doc. 98-14834 Filed 6-3-98; 8:45 am]
BILLING CODE 4120-01-P