[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Notices]
[Pages 33119-33129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16217]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-137-N]


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

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

ACTION: Notice.

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SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations and other Federal Register notices, and 
statements of policy that were published during October, November, and 
December of 1995 that relate to the Medicare and Medicaid programs. It 
also identifies certain devices with investigational device exemption 
numbers approved by the Food and Drug Administration that may be 
potentially covered under Medicare.
    Section 1871(c) of the Social Security Act requires that we publish 
a list of Medicare issuances in the Federal Register at least every 3 
months. Although we are not mandated to do so by statute, for the sake 
of completeness of the listing, we are including all Medicaid issuances 
and Medicare and Medicaid substantive and interpretive regulations 
(proposed and final) published during this time frame. We are also 
providing the content of revisions to the Medicare Coverage Issues 
Manual published during the period October 1 through December 31, 1995. 
On August 21, 1989, we published the content of the Manual (54 FR 
34555) and indicated that we will publish quarterly any updates. Adding 
to this listing the complete text of the changes to the Medicare 
Coverage Issues Manual fulfills this requirement in a manner that 
facilitates identification of coverage and other changes in our 
manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 786-5255 (For Medicare instruction information).
Pat Prete, (410) 786-3246 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Cathy Johnson, (410) 786-5241 (For all other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

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

[[Page 33120]]

substantive and interpretive regulations published during October 
through December 1995.

II. Medicare Coverage Issues

    We receive numerous inquiries from the general public about whether 
specific items or services are covered under Medicare. Providers, 
carriers, and intermediaries have copies of the Medicare Coverage 
Issues Manual, which identifies those medical items, services, 
technologies, or treatment procedures that can be paid for under 
Medicare. On August 21, 1989, we published a notice in the Federal 
Register (54 FR 34555) that contained all the Medicare coverage 
decisions issued in that manual.
    In that notice, we indicated that revisions to the Coverage Issues 
Manual will be published at least quarterly in the Federal Register. We 
also sometimes issue proposed or final national coverage decision 
changes in separate Federal Register notices. Readers should find this 
an easy way to identify both issuance changes to all our manuals and 
the text of changes to the Coverage Issues Manual.
    Revisions to the Coverage Issues Manual are not published on a 
regular basis but on an as-needed basis. We publish revisions as a 
result of technological changes, medical practice changes, responses to 
inquiries we receive seeking clarifications, or the resolution of 
coverage issues under Medicare. If no Coverage Issues Manual revisions 
were published during a particular quarter, our listing will reflect 
that fact.
    Not all revisions to the Coverage Issues Manual contain major 
changes. As with any instruction, sometimes minor clarifications or 
revisions are made within the text. This notice contains, as Addendum 
IV, reprinted manual revisions as transmitted to manual holders. The 
new text is shown in italics. We have not reprinted the table of 
contents, since the table of contents serves primarily as a finding aid 
for the user of the manual and does not identify items as covered or 
not.

III. How to Use the Addenda

    This notice is organized so that a reader may review the subjects 
of all manual issuances, memoranda, substantive and interpretive 
regulations, coverage decisions, or Food and Drug Administration-
approved investigational device exemptions published during the time 
frame to determine whether any are of particular interest. We expect it 
to be used in concert with previously published notices. Most notably, 
those unfamiliar with a description of our Medicare manuals may wish to 
review Table I of our first three notices (53 FR 21730, 53 FR 36891, 
and 53 FR 50577) and the notice published March 31, 1993 (58 FR 16837), 
and those desiring information on the Medicare Coverage Issues Manual 
may wish to review the August 21, 1989 publication (54 FR 34555).
    To aid the reader, we have organized and divided this current 
listing into six addenda. Addendum I identifies updates that changed 
the Coverage Issues Manual. We published notices in the Federal 
Register that included the text of changes to the Coverage Issues 
Manual. These updates, when added to material from the manual published 
on August 21, 1989 constitute a complete manual as of the end of the 
quarter covered by this notice. Parties interested in obtaining a copy 
of the manual and revisions should follow the instructions in section 
IV of this notice.
    Addendum II identifies previous Federal Register documents that 
contain a description of all previously published HCFA Medicare and 
Medicaid manuals and memoranda.
    Addendum III of this notice lists, for each of our manuals or 
Program Memoranda, a HCFA transmittal number unique to that instruction 
and its subject matter. A transmittal may consist of a single 
instruction or many. Often it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
    Addendum IV sets forth the revisions to the Medicare Coverage 
Issues Manual that were published during the quarter covered by this 
notice. For the revisions, we give a brief synopsis of the revisions as 
they appear on the transmittal sheet, the manual section number, and 
the title of the section. We present a complete copy of the revised 
material, no matter how minor the revision, and identify the revisions 
by printing in italics the text that was changed. If the transmittal 
includes material unrelated to the revised section, for example, when 
the addition of revised material causes other sections to be 
repaginated, we do not reprint the unrelated material.
    Addendum V lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice. For each item, we 
list the date published, the Federal Register citation, the parts of 
the Code of Federal Regulations (CFR) that have changed (if 
applicable), the agency file code number, the title of the regulation, 
the ending date of the comment period (if applicable), and the 
effective date (if applicable).
    On September 19, 1995, we published a final rule (60 FR 48417) 
establishing in regulations that certain devices with an 
investigational device exemption approved by the Food and Drug 
Administration and certain services related to those devices may be 
covered under Medicare. That final rule states that we will announce in 
this quarterly notice all investigational device exemption 
categorizations, using the investigational device exemption numbers the 
Food and Drug Administration assigns. Addendum VI includes listings of 
the Food and Drug Administration-approved investigational device 
exemption numbers that have been approved during the quarter covered by 
this notice. The listings are organized according to the categories to 
which the device numbers are assigned (that is, Category A or Category 
B, and identified by the investigational device exemption number). 
Future notices will announce investigational device exemption 
categorizations and the numbers assigned by the Food and Drug 
Administration for the quarter for which the notices cover.

IV. How to Obtain Listed Material

A. Manuals

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

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

    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell.

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the

[[Page 33121]]

address given above. When ordering individual copies, it is necessary 
to cite either the date of publication or the volume number and page 
number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both text and graphics from Volume 59, Number 1 (January 2, 1994) 
forward. Free public access is available on a Wide Area Information 
Server (WAIS) through the Internet and via asynchronous dial-in. 
Internet users can access the database by using (1) the World Wide 
Web--the Superintendent of Documents home page address is http://
www.access.gpo.gov/su__docs/; (2) local WAIS client software, or (3) 
telnet--swais.access.gpo.gov, then login as guest (no password 
required). Dial-in users should use communications software and modem 
to call (202) 512-1661; type swais, then login as guest (no password 
required). For general information about GPO Access, contact the GPO 
Access User Support Team by sending Internet e-mail to [email protected]
gpo.gov; by faxing to (202) 512-1262; or by calling (202) 512-1530 
between 7 a.m. and 5 p.m. Eastern time, Monday-Friday, except for 
Federal holidays.

C. Rulings

    We publish Rulings on an infrequent basis. Interested individuals 
can obtain copies from the nearest HCFA Regional Office or review them 
at the nearest regional depository library. We also sometimes publish 
Rulings in the Federal Register.

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

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

V. How to Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 1400 designated libraries 
throughout the United States. Interested parties may examine the 
documents at any one of the FDLs. Some may have arrangements to 
transfer material to a local library not designated as an FDL. To 
locate the nearest FDL, contact any library.
    In addition, individuals may contact regional depository libraries, 
which receive and retain at least one copy of most Federal government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library. Superintendent of Documents 
numbers for each HCFA publication are shown in Addendum III, along with 
the HCFA publication and transmittal numbers. To help FDLs locate the 
instruction, use the Superintendent of Documents number, plus the HCFA 
transmittal number. For example, to find the Carriers Manual, Part 3--
Claims Process (HCFA-Pub. 14-3) transmittal entitled ``Self-
Administered Drugs and Biologicals,'' use the Superintendent of 
Documents No. HE 22.8/7 and the HCFA transmittal number 1528.

VI. General Information

    It is possible that an interested party may have a specific 
information need and not be able to determine from the listed 
information whether the issuance or regulation would fulfill that need. 
Consequently, we are providing information contact persons to answer 
general questions concerning these items. Copies are not available 
through the contact persons. Copies can be purchased or reviewed as 
noted above.
    Questions concerning Medicare items in Addenda III may be addressed 
to Margaret Cotton, Bureau of Program Operations, Issuances Staff, 
Health Care Financing Administration, S3-01-27, 7500 Security Blvd., 
Baltimore, MD 21244-1850, Telephone (410) 786-5255.
    Questions concerning Medicaid items in Addenda III may be addressed 
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care 
Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore, 
MD 21244-1850, Telephone (410) 786-3246.
    Questions concerning Food and Drug Administration- approved 
investigational device exemptions may be addressed to Sharon Hippler, 
Bureau of Policy Development, Office of Chronic Care and Insurance 
Policy, Health Care Financing Administration, C4-11-04, 7500 Security 
Blvd., Baltimore, MD 21244-1850, Telephone (410) 786-4633.
    Questions concerning all other information may be addressed to 
Cathy Johnson, Bureau of Policy Development, Office of Regulations, 
Health Care Financing Administration, C5-09-05, 7500 Security Blvd., 
Baltimore, MD 21244-1850, Telephone (410) 786-5241.

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

    Dated: June 6, 1996.
Carol Walton,
Director, Bureau of Program Operations.

Addendum I

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

January 3, 1995 (60 FR 132)
April 6, 1995 (60 FR 17538)
July 26, 1995 (60 FR 38344)
November 15, 1995 (60 FR 57435)
April 8, 1996 (61 FR 15491)

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 33122]]



        Addendum III.--Medicare and Medicaid Manual Instructions        
                     [October through December 1995]                    
------------------------------------------------------------------------
   Trans. No.                     Manual/Subject/Publication No.        
------------------------------------------------------------------------
                          Intermediary Manual                           
                Part 3--Claims Process (HCFA--Pub. 13-3)                
              (Superintendent of Documents No. HE 22.8/6-1)             
------------------------------------------------------------------------
1662               The MRA is for the evaluation of the carotid vessels in 
the head and neck;
     The MRA is performed on patients with vascular conditions 
of the head and neck, such as carotid stenosis, for which surgery is 
anticipated and may be found to be appropriate based on the MRA test 
results; and
     The MRA is performed when conventional catheter 
angiography is inappropriate because the patient has contraindications 
to contrast media.
    Readily acceptable scientific data are lacking for other 
applications of MRA. Therefore, effective for services

[[Page 33126]]

furnished on or after October 1, 1995, other applications are not 
covered.
    This limited coverage policy will be assessed and reviewed as new 
information becomes available, in order to determine whether the 
limited coverage should be continued, expanded, or retracted.
    Transmittal No. 81; section 60-20.
    Changed Procedures--Effective Date: June 1, 1995.
    This revision to the Coverage Issues Manual was originally issued 
as Transmittal #77. It is now being reissued to indicate an effective 
date of June 1, 1995. This policy may be applied to claims with a date 
of service on or after June 1, 1995. Do not reopen any claims. However, 
if claims come to your attention, process them applying the revised 
policy.
    Section 60-16, Pneumatic Compression Devices (Used for Lymphedema), 
is revised to clarify (1) that the nonsegmented and segmented pump 
without manual control of pressure in each chamber is considered the 
least costly alternative that meets the clinical needs of the 
individual for this type of durable medical equipment (HCPCS codes 
E0650 and E0651), unless there is documentation that warrants payment 
of the more costly manual control pump (HCPCS code E0652); (2) the 
documentation needed for determination of the type of pump to be used 
for the treatment of lymphedema; and (3) which pneumatic compression 
pump is appropriate for chronic venous insufficiency.

60-20  Transcutaneous Electrical Nerve Stimulators (Tens)

    TENS is a type of electrical nerve stimulator that is employed to 
treat chronic intractable pain. This stimulator is attached to the 
surface of the patient's skin over the peripheral nerve to be 
stimulated. It may be applied in a variety of settings (in the 
patient's home, a physician's office, or in an outpatient clinic). 
Payment for TENS may be made under the durable medical equipment 
benefit. (See Sec. 45-25 for an explanation of coverage of medically 
necessary supplies for the effective use of TENS and Sec. 45-19 for an 
explanation of coverage of TENS for acute post-operative pain.)
    Transmittal No. 82; sections 65-14 and 65-15.
    Changed Procedures--Effective Date: 01-22-96.
    Section 65-15, Artificial Hearts And Related Devices, amends this 
section by removing the words ``not covered'' from the title. Also, it 
revises the statement of general noncoverage of these devices to allow 
exceptions for use of the BVS 5000 for temporary life support and the 
addition of coverage of the use of the HeartMate IP LVAS for use as a 
bridge to cardiac transplantation.

65-14  Cochlear Implantation

    A cochlear implant device is an electronic instrument, part of 
which is implanted surgically to stimulate auditory nerve fibers, and 
part of which is worn or carried by the individual to capture and 
amplify sound. Cochlear implant devices are available in single channel 
and multi-channel models. The purpose of implanting the device is to 
provide an awareness and identification of sounds and to facilitate 
communication for persons who are profoundly hearing impaired.
    Medicare coverage is provided only for those patients who meet all 
of the following selection guidelines.
    A. Adults.--
      Diagnosis of total sensorineural deafness that cannot be 
mitigated by use of a hearing aid in patients whose auditory cranial 
nerves are stimulable;
      Cognitive ability to use auditory clues and a willingness 
to undergo an extended program of rehabilitation;
      Post-lingual deafness;
      Adulthood (at least 18 years of age);
      Freedom from middle ear infection, an accessible cochlear 
lumen that is structurally suited to implantation, and freedom from 
lesions in the auditory nerve and acoustic areas of the central nervous 
system; and
      No contraindications to surgery.
    B. Children (Effective for services performed on and after 12/31/
92)--.The FDA has approved marketing of a multi-channel cochlear 
implant device for use in prelingually and postlingually deafened 
children 2 through 17 years of age. (FDA-approved labeling limits use 
of the device in adults to those who are postlingually deafened.) 
Medicare coverage is provided for such a device for children who meet 
the following patient selection guidelines. There are two exceptions to 
this general prohibition for two specific devices which have been 
approved by the Food and Drug Administration. These are described 
below.
      No contraindications to the implant, including those 
described in the product's FDA-approved package insert;
      Diagnosis of bilateral profound sensorineural deafness 
with little or no benefit from a hearing (or vibrotactile) aid, as 
demonstrated by the inability to improve on age appropriate closed-set 
word identification tasks;
      Freedom from middle ear infection, an accessible cochlear 
lumen that is structurally suited to implantation, and freedom from 
lesions in the auditory nerve and acoustic areas of the central nervous 
system; and
      The device must be used in accordance with the FDA-
approved labeling.

65-15  Artificial Hearts and Related Devices

    There are several devices either in use or under development which 
replace all or part of the human heart or assist the heart in 
performing its pumping function. Artificial hearts are considered 
investigational and not covered under Medicare either when used as a 
permanent replacement for a human heart or when used as temporary life-
support systems (i.e., until a human heart becomes available for 
transplant).
    The FDA-approved ventricular assist device (known as the B.S. 5000) 
is covered when it is used in accordance with its FDA-approved labeled 
uses for postcardiotomy ventricular dysfunction. The device is intended 
for short term use and is not covered when used as a bridge to cardiac 
transplantation. The FDA-approved HeartMate Implantable Pneumatic Left 
Ventricular Assist Systems (HeartMate IP LVAS) is covered:
    A. When it is used in accordance with its FDA-approved labeled uses 
as a temporary mechanical circulatory support for approved transplant 
candidates in nonreversible left ventricular failure as a bridge to 
cardiac transplantation; and
    B. Only if all of the following conditions are met:
    1. The patient is an approved heart transplant candidate, i.e., 
approved and listed as a candidate by a Medicare-approved heart 
transplant center;
    2. The implantation of the system is done in a Medicare-approved 
heart transplant center, either on a patient listed by that center, or, 
if the patient is listed by another Medicare-approved center, with the 
written permission of the center listing the patient;
    3. The patient is on inotropes;
    4. The patient is on an intra-aortic balloon pump (if possible); 
and
    5. The patient has left atrial pressure or pulmonary capillary 
wedge pressure > 20 mm Hg with either:
    a. Systolic blood pressure < 80 mm Hg; or
    b. Cardiac index of < 2.0 1/min/m2. Coverage of this device is 
limited to its FDA-approved use as a bridge to transplantation. 
Consequently, centers implanting such devices should make every 
reasonable effort to transplant patients on such devices as soon as 
practicable. Ideally, they should

[[Page 33127]]

determine patient-specific timetables for transplantation and should 
not maintain such patients on this device if suitable hearts become 
available for transplantation.
    Other ventricular assist devices used as temporary life-support 
systems are still considered investigational and are not covered under 
the Medicare program.
    Transmittal No. 83; section 35-93.
    MANUALIZATION--EFFECTIVE DATE: NOT APPLICABLE.
    Section 35-93, 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 and Chronic Obstructive Pulmonary Disease-Not Covered.--This 
instruction explains Medicare's position of noncoverage for lung volume 
reduction. The lack of scientific evidence available at this time 
concerning the safety and effectiveness of lung volume reduction 
reveals that this procedure cannot be considered reasonable and 
necessary under Sec. 1862(a)(1)(A) of the Social Security Act.

35-93  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 and Chronic 
Obstructive Pulmonary Disease-Not Covered

    Lung volume reduction surgery or reduction pneumoplasty, also 
referred to as lung shaving or lung contouring, is performed on 
patients with emphysema and chronic obstructive pulmonary disease (OPD) 
in order to allow the underlying compressed lung to expand, and thus, 
establish improved respiratory function. The goal of this procedure is 
to offer a better quality of life for patients with emphysema and OPD. 
In addition, lung volume reduction may be offered as a ``bridge to 
transplant'' for patients who otherwise may not have been considered 
candidates for lung transplantation.
    Unilateral or bilateral lung volume reduction surgery by open or 
thoracoscopic approach is not covered because there is little medical 
evidence available to base a determination that this procedure is safe 
and effective. Therefore, lung volume reduction surgery cannot be 
considered reasonable and necessary under Sec. 1862(a)(1)(A) of the 
law. When more scientific evidence becomes available, this policy will 
be reevaluated.

                                           Addendum V.--Regulation Documents Published in the Federal Register                                          
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                                                                                                                                    End of              
     Publication date       FR Vol. 60              CFR part                     File code \1\               Regulation title      comment    Effective 
                               page                                                                                                 period       date   
--------------------------------------------------------------------------------------------------------------------------------------------------------
10/02/95.................   51483-51487  .............................  ORD-079-N......................  New and Pending          .........     10/02/95
                                                                                                          Demonstration Project                         
                                                                                                          Proposals Submitted                           
                                                                                                          Pursuant to Section                           
                                                                                                          1115(a) of the Social                         
                                                                                                          Security Act: June                            
                                                                                                          1995.                                         
10/06/95.................   52396-52403  .............................  BPD-797-PN.....................  Medicare Program:         12/05/95  ...........
                                                                                                          Limitations on                                
                                                                                                          Medicare Coverage of                          
                                                                                                          Cataract Surgery.                             
10/10/95.................   52684-52688  .............................  ORD-080-N......................  New and Pending          .........     10/10/95
                                                                                                          Demonstration Project                         
                                                                                                          Proposals Submitted                           
                                                                                                          Pursuant to Section                           
                                                                                                          1115(a) of the Social                         
                                                                                                          Security Act: July                            
                                                                                                          1995.                                         
10/10/95.................         52731  489, 498.....................  HSQ-156-CN.....................  Medicare and Medicaid    .........     07/01/95
                                                                                                          Programs; Survey,                             
                                                                                                          Certification and                             
                                                                                                          Enforcement of Skilled                        
                                                                                                          Nursing Facilities and                        
                                                                                                          Nursing Facilities;                           
                                                                                                          Correction.                                   
10/13/95.................         53456  489..........................  HSQ-156-CN.....................  Medicare and Medicaid    .........     07/01/95
                                                                                                          Programs; Survey,                             
                                                                                                          Certification and                             
                                                                                                          Enforcement of Skilled                        
                                                                                                          Nursing Facilities and                        
                                                                                                          Nursing Facilities;                           
                                                                                                          Correction.                                   
10/16/95.................   53625-53626  .............................  OACT-049-N.....................  Medicare Program;        .........     01/01/96
                                                                                                          Inpatient Hospital                            
                                                                                                          Deductible and                                
                                                                                                          Hospital and Extended                         
                                                                                                          Care Services                                 
                                                                                                          Coinsurance Amounts                           
                                                                                                          for 1996.                                     
10/16/95.................   53626-53631  .............................  OACT-050-N.....................  Medicare Program;        .........     01/01/96
                                                                                                          Monthly Actuarial                             
                                                                                                          Rates and Monthly                             
                                                                                                          Supplementary Medical                         
                                                                                                          Insurance Premium Rate                        
                                                                                                          Beginning January 1,                          
                                                                                                          1996.                                         
10/16/95.................   53631-53632  .............................  OACT-051-N.....................  Medicare Program; Part   .........     01/01/96
                                                                                                          A Premium for 1996 for                        
                                                                                                          the Uninsured Aged and                        
                                                                                                          for Certain Disabled                          
                                                                                                          Individuals Who Have                          
                                                                                                          Exhausted Other                               
                                                                                                          Entitlement.                                  
10/18/95.................   53876-53877  411..........................  BPD-482-CN.....................  Medicare Program;        .........     09/29/95
                                                                                                          Medicare Secondary                            
                                                                                                          Payer for Individuals                         
                                                                                                          Entitled to Medicare                          
                                                                                                          and Also Covered Under                        
                                                                                                          Group Health Plans;                           
                                                                                                          Correction.                                   
10/18/95.................         53877  414..........................  BPD-830-F......................  Medicare Program;        .........     09/29/95
                                                                                                          Authority Citations;                          
                                                                                                          Technical Amendments.                         
10/18/95.................         53877  486..........................  BPD-836-F......................  Medicare Program;        .........     09/29/95
                                                                                                          Suppliers of                                  
                                                                                                          Specialized Services;                         
                                                                                                          Technical Amendment.                          
11/15/95.................   57435-57448  .............................  BPO-132-N......................  Medicare and Medicaid    .........     11/15/95
                                                                                                          Programs; Quarterly                           
                                                                                                          Listing of Program                            
                                                                                                          Issuances and Coverage                        
                                                                                                          Decisions--Second                             
                                                                                                          Quarter 1995.                                 
11/28/95.................   58631-58632  .............................  OPL-007-N......................  Medicare Program;        .........     11/28/95
                                                                                                          December 11, 1995                             
                                                                                                          Meeting of the                                
                                                                                                          Practicing Physicians                         
                                                                                                          Advisory Council.                             

[[Page 33128]]

                                                                                                                                                        
11/29/95.................   61264-61265  .............................  BPD-820-N......................  Medicare Program;        .........     11/29/95
                                                                                                          Notice Containing the                         
                                                                                                          Statement Drafted by                          
                                                                                                          the Committee                                 
                                                                                                          Established to                                
                                                                                                          Negotiate the Wage                            
                                                                                                          Index To Be Used to                           
                                                                                                          Adjust Hospice Payment                        
                                                                                                          Rates Under Medicare.                         
11/30/95.................   61483-61487  .............................  MB-085-F.......................  Medicare Program; Nurse- .........     01/02/96
                                                                                                          Midwife Services.                             
12/01/95.................   61704-61705  .............................  OPL-008-N......................  Medicare Program;        .........     12/01/95
                                                                                                          Request for                                   
                                                                                                          Nominations for                               
                                                                                                          Members for the                               
                                                                                                          Practicing Physicians                         
                                                                                                          Advisory Council.                             
12/05/95.................   62237-62241  413..........................  BPD-788-P......................  Medicare Program;         02/05/96  ...........
                                                                                                          Uniform Electronic                            
                                                                                                          Cost Reporting for                            
                                                                                                          Skilled Nursing                               
                                                                                                          Facilities and Home                           
                                                                                                          Health Agencies.                              
12/08/95.................   63124-63357  400, 405, 410, 411, 412, 413,  BPD-827-FC.....................  Medicare Program;         02/06/96   \2\ 01/01/
                                          414, 415, 417, 489.                                             Revisions to Payment                        96
                                                                                                          Policies and                                  
                                                                                                          Adjustments to the                            
                                                                                                          Relative Value Units                          
                                                                                                          Under the Physician                           
                                                                                                          Fee Schedule for                              
                                                                                                          Calendar Year 1996.                           
12/08/95.................   63358-63366  .............................  BPD-828-FN.....................  Medicare Program;        .........   \3\ 10/01/
                                                                                                          Physician Fee Schedule                      95
                                                                                                          Update for Calendar                           
                                                                                                          Year 1996 and                                 
                                                                                                          Physician Volume                              
                                                                                                          Performance Standard                          
                                                                                                          Rates of Increase for                         
                                                                                                          Federal Fiscal Year                           
                                                                                                          1996.                                         
12/11/95.................   63438-63440  411..........................  BPD-850-F......................  Medicare Program;        .........     12/11/95
                                                                                                          Physician Self-                               
                                                                                                          Referral Regulations:                         
                                                                                                          Change in Date for                            
                                                                                                          Submission of Group                           
                                                                                                          Attestation Statement.                        
12/11/95.................   63440-63444  424..........................  BPD-838-FC.....................  Medicare Program;         02/09/96     01/01/96
                                                                                                          Additional Supplier                           
                                                                                                          Standards.                                    
12/11/95.................   63532-63536  .............................  ORD-081-N......................  New and Pending          .........     12/11/95
                                                                                                          Demonstration Project                         
                                                                                                          Proposals Submitted                           
                                                                                                          Pursuant to Section                           
                                                                                                          1115(a) of the Social                         
                                                                                                          Security Act: August                          
                                                                                                          and September 1995.                           
12/15/95.................   64440-64444  .............................  ORD-082-N......................  New and Pending          .........    12/15/95 
                                                                                                          Demonstration Project                         
                                                                                                          Proposals Submitted                           
                                                                                                          Pursuant to Section                           
                                                                                                          1115(a) of the Social                         
                                                                                                          Security Act: October                         
                                                                                                          1995.                                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ GN--General Notice; PN--Proposed Notice, FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final Rule; FC--Final Rule with Comment      
  Period; CN--Correction Notice; SN--Suspension Notice; WN--Withdrawal Notice; NR--Notice of HCFA Ruling.                                               
\2\ Except CFR Part 415, 07/01/96.                                                                                                                      
\3\ For Volume Performance Standard Rates of Increase; 01/01/96 for Medicare Physician Fee Schedule Update.                                             



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

    Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices 
fall into one of three classes:
    Class I--Devices for which the general controls of the Food, Drug, 
and Cosmetic Act, such as adherence to good manufacturing practice 
regulations, are sufficient to provide a reasonable assurance of safety 
and effectiveness.
    Class II--Devices that, in addition to general controls, require 
special controls, such as performance standards or postmarket 
surveillance, to provide a reasonable assurance of safety and 
effectiveness.
    Class III--Devices that cannot be classified into Class I or Class 
II because insufficient information exists to determine that either 
special or general controls would provide reasonable assurance of 
safety and effectiveness. Class III devices require premarket approval.
    Under the new categorization process to assist HCFA, the Food and 
Drug Administration assigns each device with a Food and Drug 
Administration-approved investigational device exemption to one of two 
categories: Experimental/Investigational (Category A) Devices, or Non-
Experimental/Investigational (Category B) Devices. Under this 
categorization process, an experimental/investigational (Category A) 
device is an innovative device in Class III for which ``absolute risk'' 
of the device type has not been established (that is, initial questions 
of safety and effectiveness have not been resolved and the Food and 
Drug Administration is unsure whether the device type can be safe and 
effective). A non-experimental/investigational (Category B) device is a 
device believed to be in Class I or Class II, or a device believed to 
be in Class III for which the incremental risk is the primary risk in 
question (that is, underlying questions of safety and effectiveness of 
that device type have been resolved), or it is known that the device 
type can be safe and effective because, for example, other 
manufacturers have obtained Food and Drug Administration approval for 
that device type.
    There were no new FDA-approved IDE device numbers in Category A to 
report for this quarter.
    The criteria the Food and Drug Administration uses to categorize an 
investigational device under Category B include the following:
    (1) Devices, regardless of the classification, under investigation 
to establish substantial equivalence to a predicate device, that is, to 
establish substantial equivalence to a previously/currently legally 
marketed device.
    (2) Class III devices whose technological characteristics and 
indication for use are comparable to a PMA-approved device.
    (3) Class III devices with technological advances compared to a 
PMA-approved device, that is, a device with technological changes that 
represent advances to a device that has

[[Page 33129]]

already received PMA-approval (generational changes).
    (4) Class III devices that are comparable to a PMA-approved device 
but are under investigation for a new indication for use. For purposes 
of studying the new indication, no significant modification to the 
device were required.
    (5) Pre-amendments Class III devices that become the subject of an 
investigational device exemption after the Food and Drug Administration 
requires premarket approval, that is, no PMA application was submitted 
or the PMA application was denied.
    (6) Nonsignificant risk device investigations for which the Food 
and Drug Administration required the submission of an investigational 
device exemption.
    The following information presents the device number, category (in 
this case, B), and criterion code.

G950165 B3
G950167 B2
G950169 B3
G950170 B4
G950172 B3
G950173 B1
G950174 B4
G950179 B1
G950180 B1
G950181 B1
G950183 B3
G950184 B1
G950187 B2
G950188 B1
G950189 B1
G950190 B4
G950191 B4
G950192 B6
G950193 B4
G950195 B1
G950196 B4
G950197 B3
G950198 B1
G950201 B1
G950202 B4
G950206 B1
G950208 B3
G950209 B4

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

[FR Doc. 96-16217 Filed 6-25-96; 8:45 am]
BILLING CODE 4120-01-P