[Federal Register Volume 61, Number 68 (Monday, April 8, 1996)]
[Notices]
[Pages 15491-15504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8623]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-136-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances and Coverage Decisions; Third Quarter 1995
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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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 July, August, and
September of 1995 that relate to the Medicare and Medicaid programs. It
also identifies certain devices with investigational device exemption
numbers approved by the Food and Drug Administration that may be
potentially covered under Medicare.
Section 1871(c) of the Social Security Act requires that we publish
a list of Medicare issuances in the Federal Register at least every 3
months. Although we are not mandated to do so by statute, for the sake
of completeness of the listing, we are including all Medicaid issuances
and Medicare and Medicaid substantive and interpretive regulations
(proposed and final) published during this timeframe. We are also
providing the content of revisions to the Medicare Coverage Issues
Manual published during the period July 1 through September 30, 1995.
On August 21, 1989, we published the content of the Manual (54 FR
34555) and indicated that we will publish quarterly any updates. Adding
to this listing the complete text of the changes to the Medicare
Coverage Issues Manual fulfills this requirement in a manner that
facilitates identification of coverage and other changes in our
manuals.
FOR FURTHER INFORMATION CONTACT:
Margaret Cotton, (410) 786-5255 (For Medicare instruction information).
Pat Prete, (410) 786-3246 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Nancy Ranels, (410) 786-8928 (For all other information).
SUPPLEMENTARY INFORMATION:
I. Program Issuances
The Health Care Financing Administration (HCFA) is responsible for
administering the Medicare and Medicaid programs, which pay for health
care and related services for 38 million Medicare beneficiaries and 36
million Medicaid recipients. Administration of these programs involves
(1) providing information to Medicare beneficiaries and Medicaid
recipients, health care providers, and the public, and (2) effective
communications with regional offices, State governments, State Medicaid
Agencies, State Survey Agencies, various providers of health care,
fiscal intermediaries and carriers that process claims and pay bills,
and others. To implement the various statutes on which the programs are
based, we issue regulations under authority granted the Secretary under
sections 1102, 1871, and 1902 and related provisions of the Social
Security Act (the Act) and also issue various manuals, memoranda, and
statements necessary to administer the programs efficiently.
Section 1871(c)(1) of the Act requires that we publish in the
Federal Register at least every 3 months a list of all Medicare manual
instructions, interpretive rules, statements of policy, and guidelines
of general applicability not issued as regulations. We published our
first notice June 9, 1988 (53 FR 21730). Although we are not mandated
to do so by statute, for the sake of completeness of the listing of
operational and policy statements, we are continuing our practice of
including Medicare substantive and interpretive regulations (proposed
and final) published during the 3-month timeframe. Since the
publication of our quarterly listing on June 12, 1992 (57 FR 24797), we
decided to add Medicaid issuances to our quarterly listings.
Accordingly, we list in this notice Medicaid issuances and Medicaid
substantive and interpretive regulations published during July 1
through September 1995.
II. Medicare Coverage Issues
We receive numerous inquiries from the general public about whether
specific items or services are covered under Medicare. Providers,
carriers, and intermediaries have copies of the Medicare Coverage
Issues Manual, which identifies those medical items, services,
technologies, or treatment procedures that can be paid for under
Medicare.
On August 21, 1989, we published a notice in the Federal Register
(54 FR 34555) that contained all the Medicare coverage decisions issued
in that manual.
In that notice, we indicated that revisions to the Coverage Issues
Manual will be published at least quarterly in the Federal Register. We
also sometimes issue proposed or final national coverage decision
changes in separate
[[Page 15492]]
Federal Register notices. Readers should find this an easy way to
identify both issuance changes to all our manuals and the text of
changes to the Coverage Issues Manual.
Revisions to the Coverage Issues Manual are not published on a
regular basis but on an as-needed basis. We publish revisions as a
result of technological changes, medical practice changes, responses to
inquiries we receive seeking clarifications, or the resolution of
coverage issues under Medicare. If no Coverage Issues Manual revisions
were published during a particular quarter, our listing will reflect
that fact.
Not all revisions to the Coverage Issues Manual contain major
changes. As with any instruction, sometimes minor clarifications or
revisions are made within the text. This notice contains, as Addendum
IV, reprinted manual revisions as transmitted to manual holders. The
new text is shown in italics. We have not reprinted the table of
contents, since the table of contents serves primarily as a finding aid
for the user of the manual and does not identify items as covered or
not.
III. How to Use the Addenda
This notice is organized so that a reader may review the subjects
of all manual issuances, memoranda, substantive and interpretive
regulations, coverage decisions, or Food and Drug Administration-
approved investigational device exemptions published during the
timeframe to determine whether any are of particular interest. We
expect it to be used in concert with previously published notices. Most
notably, those unfamiliar with a description of our Medicare manuals
may wish to review Table I of our first three notices (53 FR 21730, 53
FR 36891, and 53 FR 50577) and the notice published March 31, 1993 (58
FR 16837), and those desiring information on the Medicare Coverage
Issues Manual may wish to review the August 21, 1989, publication (54
FR 34555).
To aid the reader, we have organized and divided this current
listing into six addenda. Addendum I identifies updates that changed
the Coverage Issues Manual. We published notices in the Federal
Register that included the text of changes to the Coverage Issues
Manual. These updates, when added to material from the manual published
on August 21, 1989, constitute a complete manual as of September 30,
1995. Parties interested in obtaining a copy of the manual and
revisions should follow the instructions in section IV of this notice.
Addendum II identifies previous Federal Register documents that
contain a description of all previously published HCFA Medicare and
Medicaid manuals and memoranda.
Addendum III of this notice lists, for each of our manuals or
Program Memoranda, a HCFA transmittal number unique to that instruction
and its subject matter. A transmittal may consist of a single
instruction or many. Often it is necessary to use information in a
transmittal in conjunction with information currently in the manuals.
Addendum IV sets forth the revisions to the Medicare Coverage
Issues Manual that were published during the quarter covered by this
notice. For the revisions, we give a brief synopsis of the revisions as
they appear on the transmittal sheet, the manual section number, and
the title of the section. We present a complete copy of the revised
material, no matter how minor the revision, and identify the revisions
by printing in italics the text that was changed. If the transmittal
includes material unrelated to the revised section, for example, when
the addition of revised material causes other sections to be
repaginated, we do not reprint the unrelated material.
Addendum V lists all substantive and interpretive Medicare and
Medicaid regulations and general notices published in the Federal
Register during the quarter covered by this notice. For each item, we
list the date published, the Federal Register citation, the title of
the regulation, the parts of the Code of Federal Regulations (CFR) that
have changed (if applicable), the agency file code number, the ending
date of the comment period (if applicable), and the effective date (if
applicable).
On September 19, 1995, we published a final rule (60 FR 48417)
establishing in regulations that certain devices with an
investigational device exemption approved by the Food and Drug
Administration and certain services related to those devices may be
covered under Medicare. That final rule states that we will announce in
this quarterly notice all investigational device exemption
categorizations, using the investigational device exemption numbers the
Food and Drug Administration assigns. Addendum VI includes the initial
list of all of the Food and Drug Administration-approved
investigational device exemption numbers organized by the categories to
which the device numbers are assigned (that is, Category A or Category
B, and identified by the investigational device exemption number).
Future notices will include the additions and deletions to this initial
list of devices with a Food and Drug Administration-approved
investigational device exemption.
IV. How to Obtain Listed Material
A. Manuals
An individual or organization interested in routinely receiving any
manual and revisions to it may purchase a subscription to that manual.
Those wishing to subscribe should contact either the Government
Printing Office (GPO) or the National Technical Information Service
(NTIS) at the following addresses:
Superintendent of Documents, Government Printing Office, ATTN: New
Order, PO Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-
1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda
listed in this notice can be purchased from NTIS. Interested parties
should identify the transmittal(s) they want. GPO or NTIS can give
complete details on how to obtain the publications they sell.
B. Regulations and Notices
Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
C. Rulings
We publish Rulings on an infrequent basis. Interested individuals
can obtain copies from the nearest HCFA Regional Office or review them
at the nearest regional depository library. We also sometimes publish
Rulings in the Federal Register.
D. HCFA's Compact Disk--Read Only Memory (CD-ROM)
Our laws, regulations, and manuals are also available on CD-ROM,
which may be purchased from GPO or NTIS on a subscription or single
copy basis. The Superintendent of Documents list ID is HCLRM, and the
stock number is 717-139-00000-3. The following material is on the CD-
ROM disk:
Titles XI, XVIII, and XIX of the Act.
HCFA-related regulations.
HCFA manuals and monthly revisions.
[[Page 15493]]
HCFA program memoranda.
The titles of the Compilation of the Social Security Laws are
current as of January 1, 1995. The remaining portions of CD-ROM are
updated on a monthly basis.
Because of complaints about the unreadability of the Appendices
(Interpretive Guidelines) in the State Operations Manual, as of March
1995, we deleted these appendices from CD-ROM. We intend to re-visit
this issue in the near future, and with the aid of newer technology, we
may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the
reports once the files have been copied to a personal computer disk.
V. How to Review Listed Material
Transmittals or Program Memoranda can be reviewed at a local
Federal Depository Library (FDL). Under the FDL program, government
publications are sent to approximately 1400 designated libraries
throughout the United States. Interested parties may examine the
documents at any one of the FDLs. Some may have arrangements to
transfer material to a local library not designated as an FDL. To
locate the nearest FDL, contact any library.
In addition, individuals may contact regional depository libraries,
which receive and retain at least one copy of most Federal government
publications, either in printed or microfilm form, for use by the
general public. These libraries provide reference services and
interlibrary loans; however, they are not sales outlets. Individuals
may obtain information about the location of the nearest regional
depository library from any library.
Superintendent of Documents numbers for each HCFA publication are
shown in Addendum III, along with the HCFA publication and transmittal
numbers. To help FDLs locate the instruction, use the Superintendent of
Documents number, plus the HCFA transmittal number. For example, to
find the Carriers Manual, Part 3--Claims Process (HCFA-Pub. 14-3)
transmittal entitled ``Electronic Data Interchange Enrollment Form,''
use the Superintendent of Documents No. HE 22.8/7 and the HCFA
transmittal number 1519.
VI. General Information
It is possible that an interested party may have a specific
information need and not be able to determine from the listed
information whether the issuance or regulation would fulfill that need.
Consequently, we are providing information contact persons to answer
general questions concerning these items. Copies are not available
through the contact persons. Copies can be purchased or reviewed as
noted above.
Questions concerning Medicare items in Addenda III may be addressed
to Margaret Cotton, Bureau of Program Operations, Issuances Staff,
Health Care Financing Administration, S3-01-27, 7500 Security Blvd.,
Baltimore, MD 21244-1850, Telephone (410) 786-5255.
Questions concerning Medicaid items in Addenda III may be addressed
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care
Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore,
MD 21244-1850, Telephone (410) 786-3246.
Questions concerning Food and Drug Administration- approved
investigational device exemptions may be addressed to Sharon Hippler,
Bureau of Policy Development, Office of Chronic Care and Insurance
Policy, Health Care Financing Administration, C4-11-04, 7500 Security
Blvd., Baltimore, MD 21244-1850, Telephone (410) 786-4633.
Questions concerning all other information may be addressed to
Nancy Ranels, Bureau of Policy Development, Office of Regulations,
Health Care Financing Administration, C5-09-05, 7500 Security Blvd.,
Baltimore, MD 21244-1850, Telephone (410) 786-8928.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: March 29, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listing of program issuances and coverage decision updates to
the Coverage Issues Manual. For a complete listing of the quarterly
updates to the Coverage Issues Manual published during March 20, 1990
through November 14, 1994, please refer to the January 3, 1995, update
(60 FR 134).
January 3, 1995 (60 FR 132)
April 6, 1995 (60 FR 17538)
July 26, 1995 (60 FR 38344)
November 15, 1995 (60 FR 57435)
Addendum II--Description of Manuals, Memoranda, and HCFA Rulings
An extensive descriptive listing of Medicare manuals and memoranda
was published on June 9, 1988, at 53 FR 21730 and supplemented on
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR
50577. Also, a complete description of the Medicare Coverage Issues
Manual was published on August 21, 1989, at 54 FR 34555. A brief
description of the various Medicaid manuals and memoranda that we
maintain was published on October 16, 1992, at 57 FR 47468.
Addendum III.--Medicare and Medicaid Manual Instructions July Through
September 1995
------------------------------------------------------------------------
Trans. No. Manual/subject/publication No.
------------------------------------------------------------------------
Intermediary Manual Part 3--Claims Process (HCFA-Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6-1)
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1655 Electronic Data Interchange Enrollment
Form HCFA-486.
1656 Medical Update and Patient Information.
1657 Medicare Part A Standard Paper Remittance
Advice.
1658 Reporting Outpatient Surgery and Other
Services.
1659 Claims Processing Terminology.
Handling Incomplete or Invalid Claims.
Data Element Requirements Matrix.
Addendum L, Data Element Requirements Matrix.
16 Provider Electronic Billing File and
6 Record Formats.
0
Alphabetic Listing of Data Elements.
Patient Information Data Definitions and Codes.
Forms HCFA-700/701, Outpatient Rehabilitative
Services Forms.
Electronic Formats for Medical Review Attachment
Information.
[[Page 15494]]
Electronic Media Claims Flat File Record for
Outpatient Rehabilitation Services--Record Type
77.
Flat File Requirements for Record Type 77,
Outpatient Rehabilitation Services.
Requirements by Record Type and Field (Data
Element) for Outpatient Rehabilitative Services.
Definition of Narrative Type Indicators.
Validating Information and Returning Submissions
Independent of Claim.
1661 HCPCS for Hospital Outpatient Radiology
Services and Other Diagnostic Procedures.
Radiology HCPCS Codes Subject to the Payment
Limit.
Other Diagnostic Services HCPCS Codes Subject to
the Payment Limit.
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Carriers Manual--Part 3, Claims Process (HCFA-Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
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1519 Electronic Data Interchange Enrollment
Form.
1520 Nurse Practitioner Services, Clinical
Nurse Specialist Services.
1521 Part B Provider Access to Limited
Eligibility Data.
Eligibility Data Available.
Contractor Implementation.
HCFA Standard Part B Eligibility Inquiry Flat File
Specifications.
HCFA Standard Part B Eligibility Response Flat
File Specifications.
1522 Nonparticipating Physicians to Provide
Notices For Elective Surgery.
1523 Services Received by Medicare
Beneficiaries Outside the United States.
1524 Drugs and Biologicals.
1525 Local MR Policy.
Internal MR Guidelines.
The Carrier Advisory Committee.
Data Analysis to Identify Aberrancies.
Medical Review Prepayment Screens.
Categories of MR Screens.
HCFA Mandated and HCFA Optional MN Screens.
Assessing an Overpayment When the CMR Was Based on
a SVRS.
The Carrier Medical Director and Carrier
Coordination.
Carrier Coordination With Peer Review
Organization.
Medicare FMR Status Report.
Medical Review.
Coordination With Carrier Medicare Fraud Unit.
National Coverage Policy.
Local MR Policy.
Internal MR Guidelines.
Utilization Guidelines and Parameters.
The Carrier Advisory Committee.
Data Analysis.
Data Analysis to Identify Aberrancies.
Aberrancies.
Taking Corrective Actions on Identified
Aberrancies.
Conducting Evaluation of Effectiveness of
Corrective Action.
Standard Postpayment Data Reports.
Evaluation of MR Prepayment Screens.
MR Screen Parameters.
HCFA Mandated and HCFA Optional MN Screens.
Postpayment MR.
Postpayment Review Personnel.
CMR Corrective Actions.
Assessing an Overpayment or Potential Overpayment
When the CMR Was Based on a Limited Sample/
Subsample.
MN Denials.
Carrier Coordination with Fiscal Intermediary.
1526 Claims Processing Terminology.
Handling Incomplete or Invalid Claims.
Data Element Requirements Matrix.
Conditional Data Element Requirements.
Data Element Requirements Matrix.
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Program Memorandum, Intermediaries (HCFA-Pub. 60A) (Superintendent of
Documents No. HE 22.8/7)
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A-95-9 Star Alert.
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Program Memorandum, Carriers (HCFA-Pub. 60B) (Superintendent of
Documents No. HE 22.8/6-5)
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B-95-5 Implementation of Limitation on
Information Provided by Suppliers on Certificates
of Medical Necessity (Sec. 1834 of the Act, as
amended by Sec. 131 of the Social Security Act
Amendments of 1994).
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[[Page 15495]]
Program Memorandum, Intermediaries/Carriers (HCFA-Pub. 60AB)
(Superintendent of Documents No. HE 22.8/6-5)
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AB-95-7 Current Status of Medicare Program
Memorandums and Letters Issued Before Calendar
Year (CY) 1995.
AB-95-8 New Interest Rate Payable on Clean Claims
Not Paid Timely.
AB-95-9 Changes in MSP Demand Process.
AB-95-10 Changes in MSP Demand Process (This PM
was reissued to correct a typographical error.)
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Program Memorandum, Medicaid State Agencies (HCFA-Pub. 17)
(Superintendent of Documents No. HE 22.8/6-5)
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95-5 Current Status of Medicaid PMs and Action
Transmittals Issued Before Calendar Year (CY)
1995.
95-6 Application of the Nursing Home
Enforcement Regulations to Life Safety Code
Surveys.
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Hospital Manual (HCFA-Pub 10) (Superintendent of Documents No. HE 22.8/
2)
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683 Reporting Outpatient Surgery and Other
Services.
684 HCPCS for Hospital Outpatient Radiology
and Other Diagnostic Procedures.
Radiology HCPCS Codes Subject to the Payment
Limit.
Other Diagnostic Services HCPCS Codes Subject to
the Payment Limit.
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Home Health Agency Manual (HCFA-Pub. 11) (Superintendent of Documents
No. HE 22.8/5)
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276 HCFA-486--Medical Update and Patient
Information.
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Skilled Nursing Facility Manual (HCFA-Pub. 12) (Superintendent of
Documents No. HE 22.8/3)
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339 Special Billing Instructions for
Pneumococcal Pneumonia, Influenza Virus and
Hepatitis B Vaccines.
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Health Maintenance Organization/Competitive Medical Plan Manual (HCFA-
Pub. 75) (Superintendent of Documents No. HE 22/8/21:989)
------------------------------------------------------------------------
15 Risk Payment.
Annual Reconciliation.
Benefit Stabilization Fund Withholds/Withdrawals.
Electronic Transfer of Funds.
Plan Payment Report.
Monthly Payment Letter.
Adjustments to County Level.
Conversion of County Per Capita Costs Into Rates
Example of AAPCC Methodology.
Definitions.
Form of Additional Benefits.
Report on Value of Additional and Supplemental
Benefits.
------------------------------------------------------------------------
Coverage Issues Manual (HCFA-Pub. 6) (Superintendent of Documents No.
HE 22.8/14)
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78 Assessing Patient's Suitability for
Electrical Nerve Stimulation Therapy.
Transcutaneous Electrical Nerve Stimulation for
Acute Post-Operative Pain.
Supplies Used in the Delivery of Transcutaneous
Electrical Nerve Stimulation and Neuromuscular
Electrical Stimulation.
Electrical Nerve Stipulators.
79 Transcendental Meditation.
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Regional Office Manual Standards and Certification (HCFA-Pub. 23-4)
(Superintendent of Documents No. HE 22.8/8-3)
------------------------------------------------------------------------
60 Request for Survey of Sections 489.20 and
489.24 Essentials of Provider Agreement:
Responsibilities of Medicare Participating
Hospitals in Emergency Cases.
Model Letter Acknowledging Complaint Alleging
Noncompliance With 42 CFR 489.24 and/or the
Related Requirements of 42 CFR 489.20:
Investigation Not Warranted.
Model Letter Acknowledging Complaint Alleging
Noncompliance With 42 CFR 489.24 and/or the
Related Requirements of 42 CFR 489.20:
Investigation Warranted.
Responsibilities of Medicare Participating
Hospitals in Emergency Cases Investigation
Report.
61 Special Procedures for End Stage Renal
Disease Facilities.
Special Procedures for Laboratories.
Program Background and Responsibilities.
Validation and Complaint Surveys of CLIA-Exempt
Laboratories.
Adverse Actions.
Appeals of Adverse Actions.
Special Procedures for Accredited Laboratories.
CLIA Fee Collection Procedures.
[[Page 15496]]
Federal Surveys.
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Budget and Administration, State Operations Manual, Provider
Certification (HCFA-Pub. 7) (Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
275 Approval Process.
Resident Assessment Instrument for Long Term Care
Facilities.
276 Requirements for Specialty Hospitals.
Interpretive Guidelines--Psychiatric Hospitals.
Medicare/Medicaid Psychiatric Hospital Survey Data
(HCFA-724).
Surveyor Worksheet for Psychiatric Hospital Review
(HCFA-725).
HCFA Death Record Review Data Sheet (HCFA-726).
HCFA Nursing Complement Data (HCFA-727).
HCFA Total Nursing Staff Data (HCFA-728).
Data Collection Medical Staff Coverage (HCFA-729).
------------------------------------------------------------------------
Peer Review Organization Manual (HCFA-Pub. 19) (Superintendent of
Documents No. HE 8/8-15)
------------------------------------------------------------------------
52 Commonly Used Acronyms.
Background and Authority.
Hospital Requirements.
Hospital Penalties for Noncompliance.
RO Responsibilities.
State Agency Surveys.
PRO Review Responsibilities.
Physician Review Outline.
60-Day PRO Review: Opportunity for Discussion.
53 Glossary.
------------------------------------------------------------------------
Provider Reimbursement Manual, Part 1 (HCFA-Pub. 15-1), (Superintendent
of Documents No. HE 22.8/4)
------------------------------------------------------------------------
385 Reasonable Costs.
Factors To Be Considered in Determining Reasonable
Cost of Purchased Management and Administrative
Support Services.
Insurance Purchased From a Limited Purpose
Insurance Company.
Legal Fees and Other Related Costs.
------------------------------------------------------------------------
Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms
and Instructions--Chapter 28 (HCFA-Pub. 15-IIAB) (Superintendent of
Documents No. HE 22.8/4)
------------------------------------------------------------------------
7 Electronic Reporting Specifications for
Form-2552-92.
------------------------------------------------------------------------
Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms
and Instructions--Chapter 31 (HCFA-Pub. 15-IIAE) (Superintendent of
Documents No. HE 22.8/4)
------------------------------------------------------------------------
3 This transmittal makes corrections to
Chapter 31.
------------------------------------------------------------------------
Provider Reimbursement Manual, Part II--Provider Cost Reporting Forms
and Instructions--Chapter 34--(HCFA-Pub. 15-IIAH) (Superintendent of
Documents No. HE 22.8/4)
------------------------------------------------------------------------
3 Worksheet S-1--Independent Renal Dialysis
Facility Statistical Data.
Worksheet A--Reclassification and Adjustment of
Trial Balance of Expenses.
Worksheet A-2--Adjustment of Expenses.
------------------------------------------------------------------------
End Stage Renal Disease Network, Organizations Manual (HCFA-Pub. 81)
(Superintendent of Documents No. 22.8.9/4)
------------------------------------------------------------------------
4 Introduction.
Objectives.
Network Role.
Community Outreach Plan.
Clearinghouse Activities.
Patient Grievances.
Origin of Patient Grievances.
Scope of Grievances.
Role of Network in Resolution of Patient
Grievances.
Determining Grievances for Network Involvement.
Patient Awareness of Process.
Use of Facility Grievance Process.
[[Page 15497]]
Determination of Network Involvement.
Life-threatening Situations.
Patient Representative.
Requirement of Grievance in Writing.
Timing of Network Activity.
Written Acknowledgment of Grievance.
Conclusion of Investigation.
Exception.
Nature of Response and Potential Outcomes.
Contents of Report to Patient.
Use of ROs.
Potential Outcomes of Patient Grievance Process.
Improvement Plans.
Content of Improvement Plans.
Time period for Review, Acceptance/Rejection of
Improvement Plans.
Information that May be Disclosed.
Identity of Patient.
Facility Identity.
Conflict of Interest.
States in Each Region.
------------------------------------------------------------------------
State Medicaid Manual, Part 4--Services (HCFA-Pub. 45-4)
(Superintendent of Documents No. 22.8/10)
------------------------------------------------------------------------
68 Nurse Practitioner Services.
------------------------------------------------------------------------
Medicare/Medicaid, Sanction--Reinstatement Report
------------------------------------------------------------------------
95-8 Report of Physicians/Practitioners,
Providers and/or Other Health Care Suppliers
Excluded/Reinstated--May 1995.
95-9 Report of Physicians/Practitioners,
Providers and/or Other Health Care Suppliers
Excluded/Reinstated--June 1995.
95-10 Report of Physicians/Practitioners,
Providers and/or Other Health Care Suppliers
Excluded/Reinstated--July 1995.
------------------------------------------------------------------------
Addendum IV--Medicare Coverage Issues Manual
(For the reader's convenience, new material and changes to
previously published material are in italics. If any part of a sentence
in the manual instruction has changed, the entire line is shown in
italics. The transmittal includes material unrelated to revised
sections. In this addendum we do not reprint the unrelated material.)
Transmittal No. 78; sections 35-46 (Cont.)--35-48; sections 45-16-45-
25; sections 60-19--60-20; sections 65-7--65-9
CHANGED IMPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: For Services
Furnished On or After 08/07/95.
Section 35-46, Assessing Patient's Suitability for Electrical Nerve
Stimulation Therapy, Section 45-19, Transcutaneous Electrical Nerve
Stimulation (TENS) for Acute Post-Operative Pain, Section 45-25,
Supplies Used in the Delivery of Transcutaneous Electrical Nerve
Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES), and
Section 65-8, Electrical Nerve Stimulators, are revised to reflect that
TENS are no longer covered under the prosthetic device benefit. HCFA
has determined that they meet the definition of the durable medical
equipment benefit rather than the prosthetic device benefit.
NEW IMPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: For Services Furnished
On or After 08/07/95.
Section 60-20, Transcutaneous electrical Nerve Stimulators (TENS),
indicates that TENS are covered under the durable medical equipment
benefit. HCFA has determined that TENS meets the definition of the
durable medical equipment benefit rather than the prosthetic device
benefit. These coverage guidelines had appeared in Sec. 65-8 when TENS
were covered under the prosthetic device benefit.
DISCLAIMER
The revision date and transmittal number only apply to the redlined
material. All other material was previously published in the manual and
is only being reprinted.
35-46 ASSESSING PATIENT'S SUITABILITY FOR ELECTRICAL NERVE STIMULATION
THERAPY
Electrical nerve stimulation is an accepted modality for assessing
a patient's suitability for ongoing treatment with a transcutaneous or
an implanted nerve stimulator. Accordingly, program payment may be made
for the following techniques when used to determine the potential
therapeutic usefulness of an electrical nerve stimulator:
A. Transcutaneous Electrical Nerve Stimulation (TENS).--This
technique involves attachment of a transcutaneous nerve stimulator to
the surface of the skin over the peripheral nerve to be stimulated. It
is used by the patient on a trial basis and its effectiveness in
modulating pain is monitored by the physician or physical therapist.
Generally, the physician or physical therapist is able to determine
whether the patient is likely to derive a significant therapeutic
benefit from continuous use of a transcutaneous stimulator within a
trial period of 1 month; in a few cases this determination may take
longer to make. Document the medical necessity for such services which
are furnished beyond the first month. (See Sec. 45-25 for an
explanation of coverage of medically necessary supplies for the
effective use of TENS.)
If TENS significantly alleviates pain, it may be considered as
primary treatment; if it produces no relief or greater discomfort than
the original
[[Page 15498]]
pain, electrical nerve stimulation therapy is ruled out. However, where
TENS produces incomplete relief, further evaluation with percutaneous
electrical nerve stimulation may be considered to determine whether an
implanted peripheral nerve stimulator would provide significant relief
from pain. (See Sec. 35-46B.)
Usually, the physician or physical therapist providing the services
will furnish the equipment necessary for assessment. Where the
physician or physical therapist advises the patient to rent the TENS
from a supplier during the trial period rather than supplying it
himself, program payment may be made for rental of the TENS as well as
for the services of the physician or physical therapist who is
evaluating its use. However, the combined program payment which is made
for the physician's or physical therapist's services and the rental of
the stimulator from a supplier should not exceed the amount which would
be payable for the total service, including the stimulator, furnished
by the physician or physical therapist alone.
B. Percutaneous Electrical Nerve Stimulation (PENS).--This
diagnostic procedure which involves stimulation of peripheral nerves by
a needle electrode inserted through the skin is performed only in a
physician's office, clinic, or hospital outpatient department.
Therefore, it is covered only when performed by a physician or incident
to physician's service. If pain is effectively controlled by
percutaneous stimulation, implantation of electrodes is warranted.
As in the case of TENS (described in subsection A), generally the
physician should be able to determine whether the patient is likely to
derive a significant therapeutic benefit from continuing use of an
implanted nerve stimulator within a trial period of 1 month. In a few
cases, this determination may take longer to make. The medical
necessity for such diagnostic services which are furnished beyond the
first month must be documented.
Note: Electrical nerve stimulators do not prevent pain but only
alleviate pain as it occurs. A patient can be taught how to employ
the stimulator, and once this is done, can use it safely and
effectively without direct physician supervision. Consequently, it
is inappropriate for a patient to visit his physician, physical
therapist or an outpatient clinic on a continuing basis for
treatment of pain with electrical nerve stimulation. Once it is
determined that electrical nerve stimulation should be continued as
therapy and the patient has been trained to use the stimulator, it
is expected that a stimulator will be implanted or the patient will
employ the TENS on a continual basis in his home. Electrical nerve
stimulation treatments furnished by a physician in his office, by a
physical therapist or outpatient clinic are excluded from coverage
by section 1862(a)(1) of the law. (See secton 65-8 for an
explanation of coverage of the therapeutic use of implanted
peripheral nerve stimulators under the prosthetic devices benefit.
See Sec. 60-20 for an explanation of coverage of the therapeutic use
of TENS under the durable medical equipment benefit.)
45-19 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR ACUTE
POST-OPERATIVE PAIN
The use of transcutaneous electrical nerve stimulation (TENS) for
the relief of acute post-operative pain is covered under Medicare. TENS
may be covered whether used as an adjunct to the use of drugs, or as an
alternative to drugs, in the treatment of acute pain resulting from
surgery.
TENS devices, whether durable or disposable, may be used in
furnishing this service. When used for the purpose of treating acute
post-operative pain, TENS devices are considered supplies. As such they
may be hospital supplies furnished inpatients covered under Part A, or
supplies incident to a physician's service when furnished in connection
with surgery done on an outpatient basis, and covered under Part B.
It is expected that TENS, when used for acute post-operative pain,
will be necessary for relatively short periods of time, usually 30 days
or less. In cases when TENS is used for longer periods, contractors
should attempt to ascertain whether TENS is no longer being used for
acute pain but rather for chronic pain, in which case the TENS device
may be covered as durable medical equipment as described in Sec. 60-20.
Cross-refer: HCFA Pub. 13-3, Secs. 65-8, 3101.4, 3112.4, 3113; HCFA
Pub. 14-3, Secs. 65-8, 2050.1, 2100; HCFA Pub. 10, Secs. 65-8, 210.4,
230, 235.
45-25 SUPPLIES USED IN THE DELIVERY OF TRANSCUTANEOUS ELECTRICAL NERVE
STIMULATION (TENS) AND NEUROMUSCULAR ELECTRICAL STIMULATION (NMES)--
(Effective for services rendered (i.e., items rented or purchased) on
or after July 14, 1988.)
Transcutaneous Electrical Nerve Stimulation (TENS) and/or
Neuromuscular Electrical Stimulation (NMES) can ordinarily be delivered
to patients through the use of conventional electrodes, adhesive tapes
and lead wires. There may be times, however, where it might be
medically necessary for certain patients receiving TENS or NMES
treatment to use, as an alternative to conventional electrodes,
adhesive tapes and lead wires, a form-fitting conductive garment (i.e.,
a garment with conductive fibers which are separated from the patients'
skin by layers of fabric).
A form-fitting conductive garment (and medically necessary related
supplies) may be covered under the program only when:
1. It has received permission or approval for marketing by the Food
and Drug Administration;
2. It has been prescribed by a physician for use in delivering
covered TENS or NMES treatment; and
3. One of the medical indications outlined below is met:
The patient cannot manage without the conductive garment
because there is such a large area or so many sites to be stimulated
and the stimulation would have to be delivered so frequently that it is
not feasible to use conventional electrodes, adhesive tapes and lead
wires;
The patient cannot manage without the conductive garment
for the treatment of chronic intractable pain because the areas or
sites to be stimulated are inaccessible with the use of conventional
electrodes, adhesive tapes and lead wires;
The patient has a documented medical condition such as
skin problems that preclude the application of conventional electrodes,
adhesive tapes and lead wires;
The patient requires electrical stimulation beneath a cast
either to treat disuse atrophy, where the nerve supply to the muscle is
intact, or to treat chronic intractable pain; or
The patient has a medical need for rehabilitation
strengthening (pursuant to a written plan of rehabilitation) following
an injury where the nerve supply to the muscle is intact.
A conductive garment is not covered for use with a TENS device
during the trial period specified in Sec. 35-46 unless:
4. The patient has a documented skin problem prior to the start of
the trial period; and
5. The carrier's medical consultants are satisfied that use of such
an item is medically necessary for the patient.
(See conditions for coverage of the use of TENS in the diagnosis
and treatment of chronic intractable pain in Secs. 35- 46 and 60-20 and
the use of NMES in the treatment of disuse atrophy in Sec. 35-77.)
60-20 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS (TENS)
TENS is a type of electrical nerve stimulator that is employed to
treat chronic intractable pain. This
[[Page 15499]]
stimulator is attached to the surface of the patient's skin over the
peripheral nerve to be stimulated. It may be applied in a variety of
settings (in the patient's home, a physician's office, or in an
outpatient clinic). Payment for TENS may be made under the durable
medical equipment benefit. (See Sec. 45-25 for an explanation of
coverage of medically necessary supplies for the effective use of TENS
and Sec. 45-19 for an explanation of coverage of TENS for acute post-
operative pain.)
65-8 ELECTRICAL NERVE STIMULATORS
Two general classifications of electrical nerve stimulators are
employed to treat chronic intractable pain: peripheral nerve
stimulators and central nervous system stimulators.
A. Implanted Peripheral Nerve Stimulators.--Payment may be made
under the prosthetic device benefit for implanted peripheral nerve
stimulators. Use of this stimulator involves implantation of electrodes
around a selected peripheral nerve. The stimulating electrode is
connected by an insulated lead to a receiver unit which is implanted
under the skin at a depth not greater than \1/2\ inch. Stimulation is
induced by a generator connected to an antenna unit which is attached
to the skin surface over the receiver unit. Implantation of electrodes
requires surgery and usually necessitates an operating room.
Note: Peripheral nerve stimulators may also be employed to
assess a patient's suitability for continued treatment with an
electric nerve stimulator. As explained in Sec. 35-46, such use of
the stimulator is covered as part of the total diagnostic service
furnished to the beneficiary rather than as a prosthesis.
B. Central Nervous System Stimulators (Dorsal Column and Depth
Brain Stimulators).--The implantation of central nervous system
stimulators may be covered as therapies for the relief of chronic
intractable pain, subject to the following conditions:
1. Types of Implantations.--There are two types of implantations
covered by this instruction:
a. Dorsal Column (Spinal Cord) Neurostimulation.--The surgical
implantation of neurostimulator electrodes within the dura mater
(endodural) or the percutaneous insertion of electrodes in the epidural
space is covered.
b. Depth Brain Neurostimulation.--The stereotactic implantation of
electrodes in the deep brain (e.g., thalamus and periaqueductal gray
matter) is covered.
2. Conditions for Coverage.--No payment may be made for the
implantation of dorsal column or depth brain stimulators or services
and supplies related to such implantation, unless all of the conditions
listed below have been met:
a. The implantation of the stimulator is used only as a late resort
(if not a last resort) for patients with chronic intractable pain;
b. With respect to item a, other treatment modalities
(pharmacological, surgical, physical, or psychological therapies) have
been tried and did not prove satisfactory, or are judged to be
unsuitable or contraindicated for the given patient;
c. Patients have undergone careful screening, evaluation and
diagnosis by a multidisciplinary team prior to implantation. (Such
screening must include psychological, as well as physical evaluation);
d. All the facilities, equipment, and professional and support
personnel required for the proper diagnosis, treatment training, and
followup of the patient (including that required to satisfy item c)
must be available; and
e. Demonstration of pain relief with a temporarily implanted
electrode precedes permanent implantation.
Contractors may find it helpful to work with PROs to obtain the
information needed to apply these conditions to claims. See
Intermediary Manual, Sec. 3110.4 and Secs. 35-20 and 35-27. Transmittal
No. 79; sections 35-89-35-92 NEW IMPLEMENTING INSTRUCTIONS--EFFECTIVE
DATE: For services performed on or after October 11, 1995.
Section 35-92, Transcendental Meditation.--This section has been
added to reflect noncoverage of Transcendental meditation (TM) and the
cost of training patients to practice TM when it is prescribed as a
treatment of mild hypertension, as adjunctive therapy in the treatment
of essential hypertension, or as the sole or adjunctive treatment of
anxiety and other psychological stress-related disorders.
These instructions are to be implemented within your current
operating budget.
DISCLAIMER: The revision date and transmittal number only apply to
the redlined material. All other material was previously published in
the manual and is only being reprinted.
35-92 TRANSCENDENTAL MEDITATION--NOT COVERED
Transcendental Meditation (TM) is a skill that is claimed to
produce a state of rest and relaxation when practiced effectively.
Typically, patients are taught TM techniques over the course of several
sessions by persons trained in TM. The patient then uses the TM
technique on his or her own to induce the relaxed state. Proponents of
TM have urged that Medicare cover the training of patients to practice
TM when it is medically prescribed as treatment for mild hypertension,
as adjunctive therapy in the treatment of essential hypertension, or as
the sole or adjunctive treatment of anxiety and other psychological
stress-related disorders.
After review of this issue, we have concluded that the evidence
concerning the medical efficacy of TM is incomplete at best and does
not demonstrate effectiveness, and that a professional level of skill
is not required for the training of patients to engage in TM.
Although many articles have been written about application of TM
for patients with certain forms of hypertension and anxiety, there are
no rigorous scientific studies that demonstrate the effectiveness of TM
for use as an adjunct medical therapy for such conditions. Accordingly,
neither TM nor the training of patients for its use are covered under
the Medicare program.
Addendum V.--Regulation Document Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
End of
Publication FR vol. 60 CFR part File code * Regulation title comment Effective date
date page period
--------------------------------------------------------------------------------------------------------------------------------------------------------
07/05/95... 34885-34888 417 OMC-022-F...................... Full Reporting by Health ........... 08/04/95.
Maintenance Organizations
(HMOs) and Competitive Medical
Plans (CMPs) Paid on a Cost
Basis.
07/10/95... 35492-35498 414 BPD-494-F...................... Medicare Program; Payment for ........... 08/09/95.
Durable Medical Equipment and
Orthotic and Prosthetic
Devices.
[[Page 15500]]
07/10/95... 34598-35503 433 MB-39-F........................ Medicaid Program; Third Party ........... 09/08/95.
Liability (TPL) Cost-
Effectiveness Waivers.
07/10/95... 35544-35548 405 BP0-121-P...................... Medicare Program; Telephone and 09/08/95 07/10/95.
Electronic Requests for Review
of Part B Initial Claim
Determinations.
07/18/95... 36733-36736 410 414 BPD-789-CN..................... Medicare Program; Refinements ........... 01/01/95.
to Geographic Adjustment
Factor Values, Revisions to
Payment Policies, Adjustments
to the Relative Value Units
(RVUs) Under the Physician Fee
Schedule for Calendar Year
1995, and the 5-Year
Refinement of RVUs; Correction.
07/21/95... 37590-37596 413 BPD-409-F...................... Medicare Program; Optional ........... 08/21/95.
Payment System for Low
Medicare Volume Skilled
Nursing Facilities.
07/21/95... 37657-37660 ........... HSQ-229-N...................... CLIA Program; Approval of the ........... 07/21/95 through 07/21/97.
American Osteopathic
Association as an Accrediting
Organization.
07/21/95... 37660-37662 ........... HSQ-228-N...................... CLIA Program; Approval of the ........... 07/21/95 through 07/21/97.
American Association of Blood
Banks.
07/26/95... 38266-38272 424 BPD-709-FC..................... Medicare Program; Allowing 09/25/95 08/25/95.
Certifications and
Recertification by Nurse
Practitioners and Clinical
Nurse Specialists for Certain
Services.
07/26/95... 38400-38433 400 413 BPD-827-P...................... Medicare Program; Revisions to 09/25/95 ...............................
405 414 Payment Policies Under the
410 415 Physician Fee Schedule for
411 417 Calendar Year 1996.
412 489
07/26/95... 38344-38352 ........... BPO-131-N...................... Medicare and Medicaid Programs; ........... ...............................
Quarterly Listing of Program
Issuances and Coverage
Decisions--First Quarter 1995.
08/01/95... 39122-39123 409 484 BPD-469-CN..................... Medicare Program; Medicare ........... 02/21/95.
Coverage of Home Health
Services, Medicare Conditions
of Participation, and Home
Health Aide Supervision;
Correction.
08/02/95... 39304-39306 412 485 BPD-825-CN..................... Medicare Program; Changes to 08/01/95 ...............................
413 489 the Hospital Inpatient
424 Prospective Payment Systems
and Fiscal Year 1996 Rates;
Correction.
08/09/95... 40594-40597 ........... ORD-077-N...................... New and Pending Demonstration ........... ...............................
Project Proposals Submitted
Pursuant to Section 1115(a) of
the Social Security Act: May
1995.
08/14/95... 41914-41982 411 BPD-674-FC..................... Medicare Program; Physician 10/13/95 09/13/95.
Financial Relationships With,
and Referrals to, Health Care
Entities That Furnish Clinical
Laboratory Services; Financial
Relationship Reporting
Requirements.
08/14/95... 41893-41894 ........... OPL-006-N...................... Medicare Program; September 11, ........... ...............................
1995 Meeting of the Practicing
Physicians Advisory Council.
08/28/95... 44503-44507 ........... HSQ-230-N...................... Medicare, Medicaid, and CLIA ........... 08/28/95 to 06/30/2001.
Programs; Clinical Laboratory
Improvement Amendments of 1988
Exemption of Permit- Holding
Laboratories in the State of
New York.
08/30/95... 45085-45086 442 BPD-840-CN..................... Medicare and Medicaid Programs; ........... 02/08/95, 04/24/95, and 07/01/
486 Technical Amendatory Language 95.
493 Changes; Correction.
08/31/95... 45344-45372 400 411 BPD-482-FC..................... Medicare Program; Medicare 10/30/95 10/02/95.
Secondary Payer for
Individuals Entitled to
Medicare and Also Covered
Under Group Health Plans.
08/31/95... 45372 ........... OMC-022-F...................... Full Reporting by Health ........... 08/04/95.
Maintenance Organizations
(HMOs) and Competitive Medical
Plans (CMPs) Paid on a Cost
Basis.
09/01/95... 45673-45682 417 OMC-011-FC..................... Medicare Program; Contracts 10/31/95 10/01/95.
With Health Maintenance
Organizations (HMOS) and
Competitive Medical Plans
(CMPs).
[[Page 15501]]
09/01/95... 45778-45946 412 485 BPD-825-FC..................... Medicare Program; Changes to 10/31/95 10/01/95; except Sec. 412.46
413 489 the Hospital Inpatient which is effective 09/01/95.
424 Prospective Payment Systems
and Fiscal Year 1996 Rates.
09/06/95... 46228-46234 417 OMC-014-FC..................... Medicare Program; Payments to 10/06/95 10/01/95.
HMOs and CMPs and Appeals;
Technical Amendments.
09/06/95... 46288-46296 ........... BPO-133-PN..................... Medicare Program; Data, 11/06/95 ...............................
Standards, and Methodology
Used to Establish Fiscal Year
1996 Budgets for Fiscal
Intermediaries and Carriers.
09/08/95... 46838-46841 ........... MB-094-N....................... Medicaid Program; Limitations 09/30/95.
on Aggregate Payments to
Disproportionate Share
Hospitals: Federal Fiscal Year
1995.
09/13/95... 47534-47543 493 HSQ-225-P...................... Public Health Service; CLIA 11/13/95 ...............................
Program; Categorization of
Waived Tests.
09/15/95... 47982-47998 493 HSQ-222-P...................... CLIA Program; Categorization 11/14/95 ...............................
and Certification Requirements
for a New Subcategory of
Moderate Complexity Testing.
09/18/95... 48039-48044 405 BPD-766-F...................... Medicare Program; Standards for ........... 10/18/95.
Quality of Water Used in
Dialysis and Revised
Guidelines on Reuse of
Hemodialysis Filters for End-
Stage Renal Disease (ESRD)
Patients.
09/19/95... 48417-48425 405 411 BPD-841-FC..................... Medicare Program; Criteria and 11/20/95 11/01/95.
Procedures for Extending
Coverage to Certain Devices
and Related Services.
09/19/95... 48442-48490 441 447 MB-046-P....................... Medicaid Program; Payment for 11/20/95 ...............................
Covered Outpatient Drugs Under
Drug Rebate Agreements With
Manufacturers.
09/20/95... 48749 400 411 BPD-482-FC..................... Medicare Program; Medicare ........... 09/29/95.
Secondary Payer for
Individuals Entitled to
Medicare and Also Covered
Under Group Health Plans;
Correction.
09/26/95... 49619-49622 ........... BPD-824-N...................... Medicare Program; Update of ........... 10/01/95.
Ambulatory Surgical Center
(ASC) Payment Rates Effective
for Services On or After
October 1, 1995.
09/28/95... 50115-50120 431 488 HSQ-156-CN..................... Medicare and Medicaid Programs; ........... 07/01/95.
440 489 Survey, Certification and
442 498 Enforcement of Skilled Nursing
Facilities and Nursing
Facilities; Correction.
09/29/95... 50439-50443 401 473 BPD-830-FC..................... Medicare Program; Authority 11/28/95 09/29/95.
403 476 Citations: Technical
409 482 Amendments.
413 483
420 484
421 488
424 489
462 498
466
09/29/95... 50443-50446 400 OFH-018-F...................... Medicare and Medicaid Programs; ........... 09/29/95.
Approved Information
Collection Requirements.
09/29/95... 50446-50448 485 486 BPD-836-FC..................... Medicare Program; Providers and 11/28/95 09/29/95.
Suppliers of Specialized
Services: Technical Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* GN--General Notice; PN--Proposed Notice; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final Rule; FC--Final Rule with Comment Period;
CN--Correction Notice; SN--Suspension Notice; WN--Withdrawal Notice; NR--Notice of HCFA Ruling.
Addendum VI--Categorization of Food and Drug Administration-Approved
Investigational Device Exemptions
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices
fall into one of three classes:
Class I--Devices for which the general controls of the Food, Drug,
and Cosmetic Act, such as adherence to good manufacturing practice
regulations, are sufficient to provide a reasonable assurance of safety
and effectiveness.
Class II--Devices that, in addition to general controls, require
special controls, such as performance standards or postmarket
surveillance, to provide a reasonable assurance of safety and
effectiveness.
Class III--Devices that cannot be classified into Class I or Class
II because insufficient information exists to determine that either
special or general controls would provide reasonable assurance of
safety and effectiveness. Class III devices require premarket approval.
Under the new categorization process to assist HCFA, the Food and
Drug Administration assigns each device with a Food and Drug
Administration-approved investigational device exemption to one of two
categories: Experimental/Investigational (Category A) Devices, or Non-
Experimental/
[[Page 15502]]
Investigational (Category B) Devices. Under this categorization
process, an experimental/investigational device (Category A) is an
innovative device in Class III for which absolute risk of the device
type has not been established (that is, initial questions of safety and
effectiveness have not been resolved and the Food and Drug
Administration is unsure whether the device type can be safe and
effective). A non-experimental/investigational (Category B) device is a
device believed to be in Class I or Class II, or a device believed to
be in Class III for which the incremental risk is the primary risk in
question (that is, underlying questions of safety and effectiveness of
that device type have been resolved), or it is known that the device
type can be safe and effective because, for example, other
manufacturers have obtained Food and Drug Administration approval for
that device type.
The criteria the Food and Drug Administration uses to categorize an
investigational device under Category A include the following:
(1) Class III devices of a type for which no marketing application
has been approved through the premarket approval (PMA) process for any
indication for use. (For pre-amendments 1 Class III devices, refer
to the criteria under Category B).
1 Pre-amendments devices are devices that were marketed
before the enactment of the 1976 Medical Device Amendments to the
Food, Drug, and Cosmetic Act; that is, in commercial distribution
before May 28, 1976.
---------------------------------------------------------------------------
(2) Class III devices that would otherwise be in Category B but
have undergone significant modification for a new indication for use.
The following information presents the device number, category (in
this case, A), and criterion code for FDA approved IDE devices.
L002702 A 1, L014521 A 1, G840208 A 1, G870031 A 1, G870181 A 2,
G880028 A 1, G880063 A 1, G880151 A 1, G880210 A 2, G890047 A 1,
G890103 A 1, G890144 A 2, G890148 A 1, G890189 A 1, G890201 A 2,
G890210 A 2, G900100 A 2, G900142 A 2, G900143 A 2, G900155 A 1,
G900205 A 1, G900214 A 1, G900217 A 1, G900246 A 2, G900259 A 2,
G910034 A 1, G910064 A 2, G910078 A 2, G910083 A 1, G910121 A 1,
G910130 A 1, G910166 A 2, G910170 A 2, G910175 A 2, G910197 A 2,
G910202 A 2, G920003 A 1, G920021 A 1, G920035 A 1, G920045 A 2,
G920046 A 1, G920052 A 2, G920084 A 2, G920101 A 1, G920111 A 1,
G920211 A 1, G930054 A 2, G930063 A 1, G930092 A 1, G930115 A 2,
G930136 A 1, G930140 A 1, G930155 A 1, G930190 A 2, G930192 A 2,
G940001 A 1, G940024 A 1, G940084 A 2, G940088 A 2, G940111 A 2,
G940119 A 2, G940150 A 1, G940151 A 2, G940191 A 1, G940192 A 1,
G950058 A 2, G950062 A 1, G950083 A 2, G950093 A 1, G950096 A 1
The criteria the Food and Drug Administration uses to categorize an
investigational device under Category B include the following:
(1) Devices, regardless of the classification, under investigation
to establish substantial equivalence to a predicate device, that is, to
establish substantial equivalence to a previously/currently legally
marketed device.
(2) Class III devices whose technological characteristics and
indication for use are comparable to a PMA-approved device.
(3) Class III devices with technological advances compared to a
PMA-approved device, that is, a device with technological changes that
represent advances to a device that has already received PMA-approval
(generational changes).
(4) Class III devices that are comparable to a PMA-approved device
but are under investigation for a new indication for use. For purposes
of studying the new indication, no significant modification to the
device were required.
(5) Pre-amendments Class III devices that become the subject of an
investigational device exemption after the Food and Drug Administration
requires premarket approval, that is, no PMA application was submitted
or the PMA application was denied.
(6) Nonsignificant risk device investigations for which the Food
and Drug Administration required the submission of an investigational
device exemption.
The following information presents the device number, category (in
this case, B), and criterion code.
L010038 B 1, L010109 B 2, L010119 B 2, L010598 B 2, L010913 B 2,
L011828 B 2, L013468 B 2, L013469 B 2, L016548 B 1, L017238 B 3,
G780049 B 2, G780054 B 2, G790001 B 2, G790011 B 6, G790012 B 2,
G790016 B 1, G790018 B 2, G790022 B 2, G790023 B 2, G790030 B 2,
G790033 B 1, G800001 B 2, G800002 B 2, G800004 B 2, G800007 B 1,
G800017 B 5, G800020 B 1, G800022 B 2, G800024 B 2, G800035 B 3,
G800046 B 1, G800049 B 2, G800055 B 2, G800074 B 2, G800075 B 1,
G800077 B 2, G800083 B 4, G800124 B 2, G800129 B 3, G800138 B 2,
G800143 B 4, G810003 B 2, G810022 B 2, G810028 B 2, G810065 B 2,
G810067 B 4, G810068 B 2, G810076 B 2, G810080 B 1, G810081 B 1,
G810083 B 2, G810086 B 1, G810089 B 2, G810102 B 1, G810109 B 2,
G810113 B 1, G810115 B 3, G810122 B 2, G810123 B 2, G810127 B 2,
G810128 B 2, G810129 B 1, G810134 B 1, G810138 B 2, G810139 B 1,
G810149 B 2, G810161 B 2, G810168 B 1, G810171 B 2, G810172 B 2,
G810173 B 2, G810178 B 2, G810192 B 2, G810203 B 2, G810216 B 2,
G810218 B 2, G820012 B 2, G820019 B 2, G820033 B 1, G820036 B 2,
G820046 B 2, G820050 B 2, G820054 B 2, G820057 B 2, G820061 B 3,
G820073 B 1, G820076 B 2, G820080 B 1, G820082 B 2, G820094 B 4,
G820096 B 2, G820098 B 2, G820115 B 2, G820138 B 2, G820149 B 2,
G820157 B 2, G820165 B 2, G820903 B 1, G820904 B 1, G830017 B 4,
G830027 B 2, G830044 B 2, G830048 B 2, G830073 B 4, G830092 B 4,
G830120 B 2, G830127 B 2, G830134 B 1, G830145 B 2, G830153 B 1,
G830154 B 4, G830167 B 2, G830174 B 2, G830187 B 2, G830901 B 1,
G830903 B 1, G830907 B 2, G840008 B 1, G840018 B 1, G840028 B 3,
G840032 B 1, G840036 B 2, G840069 B 1, G840080 B 2, G840098 B 2,
G840099 B 1, G840129 B 1, G840135 B 2, G840137 B 6, G840140 B 2,
G840150 B 1, G840174 B 2, G840189 B 2, G840196 B 2, G840201 B 2,
G850010 B 2, G850012 B 1, G850017 B 1, G850030 B 2, G850040 B 2,
G850045 B 1, G850049 B 2, G850071 B 2, G850072 B 1, G850097 B 2,
G850098 B 2, G850101 B 3, G850103 B 4, G850117 B 3, G850120 B 2,
G850121 B 2, G850134 B 2, G850139 B 2, G850142 B 1, G850158 B 4,
G850162 B 2, G850174 B 2, G850187 B 2, G850188 B 3, G850202 B 2,
G850206 B 2, G850217 B 2, G850231 B 2, G850233 B 4, G850239 B 2,
G860001 B 1, G860010 B 2, G860019 B 4, G860021 B 1, G860026 B 2,
G860030 B 4, G860044 B 2, G860055 B 2, G860060 B 2, G860065 B 3,
G860066 B 2, G860067 B 2, G860070 B 3, G860075 B 2, G860077 B 2,
G860084 B 1, G860086 B 2, G860102 B 1, G860114 B 2, G860116 B 1,
G860117 B 2, G860118 B 1, G860132 B 2, G860138 B 2, G860140 B 4,
G860141 B 4, G860147 B 4, G860156 B 2, G860157 B 1, G860165 B 4,
G860168 B 2, G860169 B 2, G860170 B 2, G860172 B 2, G860176 B 1,
G860182 B 2, G860184 B 4, G860186 B 2, G860189 B 1, G860194 B 2,
G860199 B 2, G860200 B 2, G860201 B 1, G860210 B 1, G860225 B 2,
G860230 B 4, G870010 B 4, G870013 B 1,
[[Page 15503]]
G870017 B 1, G870019 B 3, G870030 B 2, G870035 B 2, G870036 B 2,
G870037 B 2, G870038 B 6, G870040 B 3, G870046 B 2, G870048 B 4,
G870049 B 1, G870052 B 1, G870053 B 2, G870055 B 6, G870056 B 6,
G870058 B 1, G870060 B 1, G870061 B 6, G870067 B 2, G870069 B 4,
G870080 B 2, G870082 B 2, G870091 B 1, G870101 B 4, G870104 B 2,
G870109 B 2, G870112 B 1, G870114 B 2, G870120 B 2, G870122 B 6,
G870123 B 2, G870129 B 2, G870134 B 6, G870136 B 2, G870142 B 4,
G870144 B 4, G870158 B 6, G870161 B 2, G870163 B 2, G870167 B 1,
G870174 B 2, G870195 B 2, G870200 B 2, G870213 B 2, G870224 B 2,
G880001 B 1, G880007 B 3, G880008 B 4, G880018 B 4, G880021 B 2,
G880022 B 3, G880026 B 1, G880032 B 3, G880040 B 2, G880042 B 1,
G880044 B 2, G880045 B 1, G880050 B 6, G880051 B 2, G880068 B 2,
G880069 B 3, G880076 B 1, G880080 B 2, G880084 B 2, G880100 B 2,
G880102 B 1, G880103 B 1, G880104 B 1, G880112 B 3, G880118 B 4,
G880122 B 2, G880123 B 6, G880129 B 2, G880131 B 2, G880136 B 6,
G880149 B 4, G880150 B 2, G880152 B 2, G880153 B 2, G880155 B 2,
G880157 B 6, G880159 B 1, G880167 B 2, G880170 B 3, G880174 B 6,
G880184 B 2, G880186 B 2, G880188 B 2, G880189 B 4, G880191 B 2,
G880193 B 2, G880194 B 2, G880197 B 4, G880208 B 1, G880213 B 3,
G880214 B 4, G880221 B 4, G880228 B 4, G880233 B 6, G880234 B 2,
G880235 B 6, G880257 B 3, G880280 B 1, G880286 B 3, G880290 B 2,
G880294 B 2, G880295 B 2, G880296 B 1, G880298 B 6, G880300 B 2,
G880301 B 2, G890001 B 3, G890003 B 6, G890005 B 2, G890006 B 2,
G890008 B 3, G890009 B 4, G890018 B 2, G890021 B 2, G890022 B 4,
G890027 B 3, G890029 B 2, G890030 B 1, G890031 B 2, G890039 B 1,
G890040 B 6, G890045 B 2, G890048 B 4, G890050 B 4, G890055 B 1,
G890058 B 2, G890060 B 2, G890064 B 3, G890074 B 4, G890077 B 4,
G890078 B 2, G890081 B 1, G890084 B 6, G890088 B 3, G890092 B 2,
G890096 B 1, G890097 B 6, G890099 B 2, G890101 B 4, G890104 B 6,
G890108 B 4, G890110 B 2, G890112 B 2, G890122 B 2, G890124 B 2,
G890130 B 2, G890137 B 4, G890138 B 3, G890140 B 2, G890149 B 2,
G890151 B 2, G890152 B 2, G890158 B 6, G890161 B 4, G890165 B 1,
G890169 B 3, G890173 B 3, G890177 B 3, G890179 B 2, G890180 B 4,
G890181 B 2, G890183 B 2, G890185 B 4, G890190 B 2, G890191 B 1,
G890196 B 3, G890197 B 2, G890198 B 6, G890200 B 2, G890208 B 2,
G890209 B 1, G890211 B 1, G890215 B 4, G890216 B 2, G890222 B 2,
G890227 B 1, G890231 B 2, G890232 B 1, G890234 B 3, G890235 B 3,
G890236 B 4, G890239 B 2, G890245 B 2, G890248 B 1, G890249 B 2,
G890250 B 2, G900005 B 1, G900006 B 2, G900007 B 2, G900008 B 4,
G900010 B 2, G900017 B 2, G900019 B 4, G900020 B 2, G900022 B 2,
G900027 B 4, G900028 B 2, G900030 B 1, G900040 B 2, G900041 B 2,
G900044 B 2, G900045 B 1, G900049 B 2, G900050 B 2, G900053 B 1,
G900055 B 2, G900058 B 2, G900059 B 2, G900060 B 2, G900062 B 2,
G900075 B 2, G900077 B 1, G900078 B 4, G900081 B 1, G900085 B 1,
G900090 B 6, G900092 B 1, G900093 B 6, G900098 B 2, G900099 B 4,
G900101 B 2, G900102 B 4, G900104 B 6, G900107 B 4, G900108 B 4,
G900109 B 2, G900110 B 2, G900113 B 6, G900119 B 2, G900122 B 2,
G900127 B 2, G900128 B 2, G900130 B 2, G900134 B 2, G900138 B 4,
G900139 B 2, G900141 B 1, G900145 B 4, G900147 B 2, G900152 B 2,
G900154 B 2, G900156 B 4, G900157 B 2, G900158 B 2, G900163 B 2,
G900164 B 2, G900166 B 2, G900167 B 4, G900168 B 2, G900175 B 4,
G900179 B 2, G900191 B 1, G900192 B 2, G900193 B 3, G900196 B 3,
G900197 B 3, G900198 B 4, G900204 B 4, G900206 B 2, G900207 B 1,
G900209 B 4, G900216 B 2, G900219 B 2, G900222 B 2, G900225 B 1,
G900226 B 2, G900228 B 2, G900231 B 6, G900233 B 2, G900237 B 3,
G900240 B 1, G900241 B 1, G900243 B 2, G900247 B 2, G900248 B 6,
G900249 B 2, G900250 B 4, G900251 B 3, G900255 B 3, G900258 B 3,
G900262 B 4, G910002 B 1, G910005 B 6, G910006 B 3, G910008 B 2,
G910009 B 1, G910016 B 2, G910018 B 2, G910026 B 3, G910028 B 2,
G910029 B 1, G910035 B 1, G910037 B 4, G910040 B 3, G910044 B 4,
G910047 B 2, G910052 B 2, G910055 B 1, G910057 B 6, G910058 B 4,
G910061 B 2, G910062 B 4, G910067 B 4, G910068 B 2, G910072 B 2,
G910073 B 1, G910080 B 1, G910082 B 1, G910084 B 4, G910085 B 1,
G910087 B 2, G910089 B 2, G910095 B 2, G910098 B 4, G910101 B 4,
G910102 B 1, G910104 B 4, G910108 B 4, G910109 B 4, G910112 B 2,
G910113 B 2, G910115 B 1, G910124 B 3, G910125 B 4, G910127 B 1,
G910128 B 1, G910129 B 1, G910132 B 4, G910133 B 3, G910134 B 2,
G910138 B 2, G910144 B 4, G910145 B 3, G910146 B 2, G910147 B 3,
G910153 B 2, G910154 B 3, G910160 B 1, G910161 B 2, G910162 B 4,
G910164 B 4, G910165 B 4, G910171 B 2, G910172 B 2, G910176 B 2,
G910177 B 3, G910178 B 2, G910184 B 3, G910186 B 3, G910187 B 1,
G910188 B 4, G910192 B 6, G910193 B 4, G910195 B 1, G910199 B 3,
G910200 B 4, G910201 B 4, G910203 B 4, G910205 B 4, G910207 B 1,
G910210 B 2, G910211 B 4, G910212 B 2, G910213 B 3, G910216 B 2,
G910218 B 4, G920006 B 2, G920007 B 2, G920015 B 4, G920016 B 3,
G920018 B 2, G920024 B 1, G920028 B 3, G920029 B 2, G920036 B 6,
G920037 B 4, G920040 B 1, G920042 B 2, G920044 B 1, G920047 B 2,
G920049 B 2, G920051 B 1, G920053 B 2, G920057 B 1, G920059 B 3,
G920060 B 2, G920062 B 2, G920063 B 4, G920070 B 2, G920071 B 2,
G920072 B 2, G920074 B 1, G920075 B 2, G920077 B 4, G920078 B 1,
G920079 B 3, G920080 B 4, G920082 B 1, G920083 B 2, G920086 B 2,
G920087 B 2, G920088 B 2, G920089 B 2, G920090 B 4, G920092 B 2,
G920094 B 2, G920096 B 1, G920097 B 4, G920099 B 2, G920100 B 2,
G920102 B 2, G920104 B 1, G920105 B 2, G920106 B 4, G920107 B 2,
G920108 B 4, G920110 B 2, G920112 B 2, G920114 B 1, G920118 B 2,
G920119 B 2, G920120 B 2, G920122 B 1, G920123 B 2, G920125 B 1,
G920126 B 2, G920127 B 1, G920129 B 2, G920130 B 2, G920131 B 1,
G920135 B 1, G920138 B 1, G920139 B 2, G920142 B 2, G920143 B 2,
G920144 B 2, G920145 B 2, G920148 B 4, G920150 B 2, G920151 B 2,
G920154 B 6, G920155 B 2, G920157 B 2, G920160 B 2, G920161 B 6,
G920162 B 4, G920163 B 2, G920164 B 6, G920165 B 2, G920166 B 1,
G920168 B 1, G920169 B 1, G920170 B 2, G920171 B 2, G920173 B 3,
G920176 B 6, G920177 B 1, G920178 B 2, G920179 B 1, G920181 B 3,
G920183 B 2, G920189 B 2, G920191 B 2, G920193 B 1, G920196 B 2,
G920199 B 2, G920200 B 2, G920203 B 4, G920206 B 4, G920208 B 2,
G920212 B 1, G920214 B 3, G920215 B 1, G920218 B 2, G920219 B 1,
G920222 B 1, G920224 B 2, G920225 B 1, G920228 B 4, G920230 B 2,
G920235 B 3, G920237 B 4, G920239 B 2, G920241 B 2, G920244 B 2,
G920245 B 4, G920249 B 2, G920251 B 2, G920252 B 2, G920253 B 1,
G920254 B 4, G920255 B 2, G920256 B 4, G920257 B 4, G930006 B 1,
G930009 B 2, G930011 B 6, G930012 B 2, G930015 B 1, G930017 B 2,
G930018 B 2, G930023 B 2, G930024 B 1, G930026 B 2, G930029 B 4,
[[Page 15504]]
G930030 B 3, G930031 B 3, G930032 B 1, G930036 B 2, G930037 B 2,
G930039 B 2, G930041 B 6, G930043 B 4, G930045 B 4, G930053 B 4,
G930057 B 6, G930058 B 2, G930061 B 1, G930062 B 1, G930069 B 1,
G930071 B 2, G930073 B 3, G930074 B 2, G930075 B 2, G930076 B 2,
G930077 B 3, G930078 B 2, G930079 B 4, G930081 B 2, G930082 B 2,
G930084 B 4, G930085 B 1, G930086 B 2, G930087 B 4, G930090 B 2,
G930091 B 2, G930097 B 2, G930099 B 3, G930102 B 4, G930104 B 2,
G930107 B 2, G930108 B 4, G930109 B 3, G930113 B 2, G930114 B 2,
G930116 B 4, G930117 B 2, G930119 B 3, G930121 B 2, G930127 B 3,
G930129 B 2, G930130 B 1, G930135 B 2, G930137 B 2, G930141 B 2,
G930142 B 4, G930143 B 6, G930146 B 6, G930147 B 2, G930150 B 4,
G930151 B 4, G930152 B 4, G930154 B 2, G930159 B 2, G930160 B 1,
G930162 B 2, G930163 B 2, G930165 B 4, G930166 B 2, G930167 B 1,
G930168 B 1, G930169 B 2, G930172 B 4, G930173 B 4, G930174 B 4,
G930175 B 2, G930176 B 2, G930178 B 4, G930180 B 1, G930182 B 3,
G930183 B 2, G930184 B 1, G930185 B 3, G930187 B 3, G930188 B 1,
G930191 B 4, G930194 B 1, G930196 B 2, G930198 B 4, G930201 B 2,
G930204 B 6, G930208 B 4, G930209 B 3, G930210 B 2, G930213 B 2,
G940002 B 4, G940003 B 3, G940004 B 3, G940005 B 3, G940006 B 1,
G940008 B 3, G940009 B 3, G940012 B 2, G940015 B 3, G940019 B 2,
G940020 B 6, G940022 B 1, G940023 B 3, G940026 B 3, G940027 B 2,
G940030 B 4, G940031 B 2, G940032 B 2, G940033 B 6, G940034 B 2,
G940036 B 4, G940038 B 2, G940040 B 1, G940041 B 1, G940042 B 2,
G940043 B 4, G940044 B 2, G940045 B 1, G940050 B 2, G940051 B 4,
G940052 B 2, G940056 B 4, G940058 B 2, G940059 B 4, G940060 B 1,
G940061 B 4, G940063 B 2, G940064 B 4, G940065 B 4, G940066 B 3,
G940067 B 4, G940069 B 2, G940070 B 1, G940071 B 3, G940072 B 3,
G940073 B 2, G940075 B 1, G940076 B 1, G940077 B 3, G940085 B 2,
G940086 B 3, G940087 B 3, G940089 B 2, G940090 B 4, G940091 B 1,
G940092 B 6, G940093 B 2, G940094 B 3, G940096 B 3, G940101 B 1,
G940103 B 1, G940105 B 2, G940106 B 1, G940107 B 6, G940108 B 2,
G940110 B 1, G940112 B 2, G940113 B 2, G940115 B 6, G940116 B 1,
G940117 B 3, G940120 B 2, G940122 B 1, G940125 B 2, G940126 B 2,
G940127 B 3, G940131 B 2, G940133 B 1, G940135 B 1, G940138 B 6,
G940140 B 6, G940141 B 4, G940143 B 1, G940147 B 1, G940149 B 1,
G940154 B 4, G940155 B 3, G940156 B 3, G940157 B 2, G940158 B 2,
G940160 B 4, G940162 B 1, G940163 B 4, G940164 B 2, G940165 B 4,
G940167 B 4, G940168 B 2, G940169 B 1, G940171 B 3, G940172 B 2,
G940176 B 3, G940177 B 2, G940178 B 3, G940184 B 3, G940186 B 2,
G940188 B 3, G940193 B 2, G940194 B 3, G950001 B 1, G950002 B 1,
G950003 B 4, G950004 B 4, G950005 B 2, G950006 B 3, G950009 B 3,
G950010 B 2, G950011 B 1, G950012 B 1, G950013 B 2, G950014 B 3,
G950015 B 4, G950016 B 3, G950017 B 4, G950018 B 4, G950019 B 3,
G950020 B 1, G950021 B 1, G950023 B 1, G950024 B 1, G950025 B 2,
G950026 B 4, G950027 B 1, G950028 B 1, G950029 B 3, G950030 B 1,
G950031 B 1, G950032 B 2, G950033 B 2, G950034 B 2, G950035 B 3,
G950037 B 1, G950038 B 4, G950040 B 2, G950041 B 3, G950043 B 3,
G950044 B 2, G950045 B 2, G950046 B 1, G950047 B 3, G950048 B 3,
G950049 B 3, G950051 B 4, G950053 B 2, G950055 B 2, G950056 B 1,
G950057 B 4, G950059 B 6, G950060 B 1, G950063 B 3, G950065 B 2,
G950067 B 2, G950068 B 1, G950069 B 4, G950072 B 2, G950073 B 2,
G950074 B 3, G950075 B 4, G950076 B 2, G950077 B 1, G950078 B 3,
G950080 B 3, G950081 B 3, G950084 B 3, G950086 B 2, G950087 B 3,
G950088 B 1, G950089 B 4, G950092 B 1, G950095 B 4, G950098 B 1,
G950099 B 2, G950101 B 2, G950104 B 4, G950106 B 4, G950107 B 3,
G950108 B 4, G950109 B 6, G950110 B 6, G950111 B 2, G950113 B 4,
G950114 B 4, G950116 B 4, G950117 B 2, G950118 B 4, G950120 B 1,
G950122 B 2, G950123 B 1, G950124 B 1, G950125 B 2, G950127 B 4,
G950130 B 4, G950131 B 4, G950133 B 4, G950134 B 2, G950135 B 2,
G950137 B 4, G950139 B 2, G950146 B 3, G950148 B 1, G950149 B 2,
G950150 B 4, G950151 B 4, G950154 B 3, G950159 B 4, G950160 B 1,
G950162 B 3, G950164 B 3.
Note: Some investigational devices may exhibit unique
characteristics or raise safety concerns that make additional
consideration necessary. For these devices, HCFA and the Food and
Drug Administration will agree on the additional criteria to be
used. The Food and Drug Administration will use these criteria to
assign the device(s) to a category. As experience is gained in the
categorization process, this addendum may be modified.
[FR Doc. 96-8623 Filed 4-5-96; 8:45 am]
BILLING CODE 4120-03-P
