[House Report 104-323]
[From the U.S. Government Publishing Office]



104th Congress                                            Rept. 104-323
                        HOUSE OF REPRESENTATIVES

 1st Session                                                     Part 1
_______________________________________________________________________


 
       REPEAL AN UNNECESSARY MEDICAL DEVICE REPORTING REQUIREMENT

                                _______


                November 7, 1995.--Ordered to be printed

_______________________________________________________________________


  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                        [To accompany H.R. 2366]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 2366) to repeal an unnecessary medical device reporting 
requirement, having considered the same, report favorably 
thereon without amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and summary..............................................     1
Background and need for legislation..............................     2
Hearings.........................................................     2
Committee consideration..........................................     2
Rollcall votes...................................................     2
Committee oversight findings.....................................     2
Committee on Government Reform and Oversight.....................     2
New budget authority and tax expenditures........................     2
Committee cost estimate..........................................     3
Congressional Budget Office estimate.............................     3
Inflationary impact statement....................................     4
Advisory committee statement.....................................     4
Section-by-section analysis and discussion.......................     4
Changes in existing law made by the bill, as reported............     4

                          Purpose and Summary

    The purpose of the bill is to repeal the Cardiac Pacemaker 
Registry established in 1984 by section 1862(h) of the Social 
Security Act (42 U.S.C. 1395y(h)). The bill strikes the 
subsection (h) that establishes the requirement for the 
Registry.

                  Background and Need for Legislation

    Section 1862(h) of the Social Security Act (42 U.S.C. 
1395y(h)) requires doctors and hospitals receiving Medicare 
funds to provide information upon implementation, removal, or 
replacement of pacemaker devices and pacemaker leads. These 
requirements became redundant in 1990 with enactment of 
amendments to the Federal Food, Drug and Cosmetic Act that 
established a more comprehensive system for reporting on 
medical devices. The legislation is needed to eliminate the 
unnecessary burden on the health care system, the Health Care 
Financing Administration, and the Food and Drug Administration.
    On October 12, 1995, the Speaker's Advisory Group on 
Corrections, a bipartisan task force, recommended to the 
Speaker that H.R. 2366 be placed on the House Corrections 
Calendar.

                                Hearings

    The Committee on Commerce has not held hearings on the 
legislation.

                        Committee Consideration

    On October 30, 1995, the Subcommittee on Health and 
Environment met in open markup session and approved H.R. 2366 
for Full Committee consideration, without amendment, by a voice 
vote. On November 1, 1995, the Full Committee met in open 
markup session and ordered H.R. 2366 reported to the House, 
without amendment, by a voice vote, a quorum being present.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and on amendments thereto. There were no 
recorded votes taken in connection with ordering H.R. 2366 
reported. A motion by Mr. Bilirakis to order H.R. 2366 reported 
to the House, without amendment, was agreed to by a voice vote.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House, the Committee has not held oversight or legislative 
hearings on this legislation.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

               New Budget Authority and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee states 
that H.R. 2366 would result in no new or increased budget 
authority or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 403 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, November 7, 1995.
Hon. Thomas J. Bliley, Jr.,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
reviewed H.R. 2366, a bill to repeal the pacemaker registry 
reporting requirement, as reported by the Committees on 
Commerce and Ways and Means on November 1, 1995. Pay-as-you-go 
procedures would not apply because the bill would not affect 
direct spending or receipts.
    H.R. 2366 would repeal Section 1862(h) of the Social 
Security Act, which establishes, through the Commissioner of 
the Food and Drug Administration, a registry of cardiac 
pacemakers and pacemaker leads for which payment is made under 
Medicare. The Secretary of Health and Human Services uses 
registry data to determine payment for pacemakers and leads 
under Medicare and for tracking the performance of these 
devices.
    Providers requesting reimbursement for the implant or 
replacement of pacemakers or leads are required to report 
various data to the registry, including the manufacturer of the 
device, the model and serial number of each device, the 
recipient's name, the location and date of the procedure, and 
any warrantees associated with the device. Under current law, 
providers billing Medicare for the replacement of a pacemaker 
or lead must return the device to its manufacturer for testing; 
the manufacturer is required to conduct these tests and to 
report the results to the provider. If a provider fails to 
return a replaced device for testing, it is prohibited from 
charging the beneficiary for the procedure. Finally, providers 
of covered services must repay to the Secretary any amounts 
received from manufacturer warrantees or device replacements.
    The Secretary can deny payment for the implantation or 
replacement of pacemakers or leads for several reasons: if the 
physician or provider fails to submit the requisite data; if 
the provider neglects to return the device or lead to the 
manufacturer, charges patients when it failed to return the 
replaced device, or fails to repay funds received under 
warrantees; or if the manufacturer fails to perform or report 
the results of the requisite tests on returned devices.
    CBO estimates that H.R. 2366 would have no budgetary 
impact. In 1995, the FDA implemented pacemaker device and lead 
tracking regulations that eliminated the need for the pacemaker 
registry. Additionally, the Health Care Financing 
Administration has established other mechanisms that better 
allow the agency to make payment determinations for pacemakers 
and leads. Thus, the registry has become obsolete.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Anne Hunt.
            Sincerely,
                                              James L. Blum
                                   (For June E. O'Neill, Director).

                     Inflationary Impact Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the bill 
would have no inflationary impact.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

             Section-by-Section Analysis of the Legislation

    Section 1 amends section 1862 of the Social Security Act 
(41 U.S.C. 1395y) by striking subsection (h).

         Changes in Existing Law Made by the Bill, as Reported

    In compliance with clause 3 of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, existing 
law in which no change is proposed is shown in roman):

                SECTION 1862 OF THE SOCIAL SECURITY ACT

        EXCLUSIONS FROM COVERAGE AND MEDICARE AS SECONDARY PAYER

    Sec. 1862. (a) * * *
          * * * * * * *
    [(h)(1)(A) The Secretary shall, through the Commissioner of 
the Food and Drug Administration, provide for a registry of all 
cardiac pacemaker devices and pacemaker leads for which payment 
was made under this title.
    [(B) Such registry shall include the manufacturer, model, 
and serial number of each such device or lead, the name of the 
recipient of such device or lead, the date and location of the 
implantation or removal of the device or lead, the name of the 
physician implanting or removing such device or lead, the name 
of the hospital or other provider billing for such procedure, 
any express or implied warranties associated with such device 
or lead under contract or State law (and any amount paid to a 
provider under any such warranty), and such other information 
as the Secretary deems to be appropriate.
    [(C) Each physician and provider of services performing the 
implantation or replacement of pacemaker devices and leads for 
which payment is made or requested to be made under this title 
shall, in accordance with regulations of the Secretary, submit 
information respecting such implantation or replacement for the 
registry.
    [(D) Such registry shall be for the purposes of assisting 
the Secretary in determining when payments may properly be made 
under this title, in tracing the performance of cardiac 
pacemaker devices and leads, in determining when inspection by 
the manufacturer of such a device or lead may be necessary 
under paragraph (3), in determining the amount subject to 
repayment under paragraph (2)(C), and in carrying out studies 
with respect to the use of such devices and leads. In carrying 
out any such study, the Secretary may not reveal any specific 
information which identifies any pacemaker device or lead 
recipient by name (or which would otherwise identify a specific 
recipient).
    [(E) Any person or organization may provide information to 
the registry with respect to cardiac pacemaker devices and 
leads other than those for which payment is made under this 
title.
    [(2) The Secretary may, by regulation, require each 
provider of services--
          [(A) to return, to the manufacturer of the device or 
        lead for testing under paragraph (3), any cardiac 
        pacemaker device or lead which is removed from a 
        patient and payment for the implantation or replacement 
        of which was made or requested by such provider under 
        this title,
          [(B) not to charge any beneficiary for replacement of 
        such a device or lead if the device or lead has not 
        been returned in accordance with subparagraph (A), and
          [(C) to make repayment to the Secretary of amounts 
        paid under this title to the provider with respect to 
        any cardiac pacemaker device or lead which has been 
        replaced by the manufacturer, or for which the 
        manufacturer has made payment to the provider, under an 
        express or implied warranty.
    [(3) The Secretary may, by regulation, require the 
manufacturer of a cardiac pacemaker device or lead (A) to test 
or analyze each pacemaker device or lead for which payment is 
made or requested under this title and which is returned to the 
manufacturer by a provider of services under paragraph (2), and 
(B) to provide the results of such test or analysis to that 
provider, together with information and documentation with 
respect to any warranties covering such device or lead. In any 
case where the Secretary has reason to believe, based upon 
information in the pacemaker registry or otherwise available to 
him, that replacement of a cardiac pacemaker device or lead for 
which payment is or may be requested under this title is 
related to the malfunction of a device or lead, the Secretary 
may require that personnel of the Food and Drug Administration 
be present at the testing of such device by the manufacturer, 
to determine whether such device was functioning properly.
    [(4) The Secretary may deny payment under this title, in 
whole or in part and for such period of time as the Secretary 
determines to be appropriate, with respect to the implantation 
or replacement of a pacemaker device or lead of a manufacturer 
performed by a physician and provider of services after the 
Secretary determines (in accordance with the procedures 
established under subsections (c), (f), and (g) of section 
1128) that--
          [(A) the physician or provider of services has failed 
        to submit information to the registry as required under 
        paragraph (1)(C),
          [(B) the provider of services has failed to return 
        devices and leads as required under paragraph (2)(A), 
        has improperly charged beneficiaries as prohibited 
        under paragraph (2)(B), or has failed to make repayment 
        to the Secretary as required under paragraph (2)(C), or
          [(C) the manufacturer of the device or lead has 
        failed to perform and to report on the testing of 
        devices and leads returned to it as required under 
        paragraph (3).]
          * * * * * * *

                                
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