Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage DecisionsFourth Quarter 1995
Federal RegisterJun 26, 1996
Ask Donna
What actually matters in this document.
Text
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.
-----------------------------------------------------------------------
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 2. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.