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



104th Congress                                            Rept. 104-323
                        HOUSE OF REPRESENTATIVES

 1st Session                                                     Part 2
_______________________________________________________________________


 
       REPEAL AN UNNECESSARY MEDICAL DEVICE REPORTING REQUIREMENT

                                _______


November 7, 1995.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

_______________________________________________________________________


    Mr. Archer, from the Committee on Ways and Means, 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 Ways and Means, 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
 1. Introduction......................................................2
        A. Purpose and summary...................................     2
        B. Background and need for legislation...................     2
        C. Legislative history...................................     2
II. Section-by-section summary of the bill, justification, and 
    comparison with present law.......................................2
III.Votes of the committee............................................3

IV. Budget effects of the bill........................................3
        A. Committee estimate of budgetary effects...............     3
        B. Statement regarding new budget authority and tax 
            expenditures.........................................     3
        C. Cost estimate prepared by the Congressional Budget 
            Office...............................................     3
 V. Other matters to be discussed under the rules of the House........4
        A. Committee oversight findings and recommendations......     4
        B. Summary of findings and recommendations of the 
            Committee on Government Reform and Oversight.........     4
        C. Inflationary impact statement.........................     4
VI. Changes in existing law made by the bill, as reported.............5

                            I. INTRODUCTION

                         a. 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.

                 b. 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 pacemakers devices and pacemaker leads. These 
requirements became redundant in 1990 with passage of the 
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.

                         c. legislative history

    H.R. 2366 was introduced on September 19th by Mrs. 
Vucanovich. On November 1, 1995, the Full Committee met in open 
session and ordered H.R. 2366 reported to the House, without 
amendment, by a voice vote, a quorum being present.

    II. SECTION-BY-SECTION SUMMARY OF THE BILL, JUSTIFICATION, AND 
                      COMPARISON WITH PRESENT LAW

                           section 1: repeal

Present law

    Section 1862(h) of the Social Security Act creates a 
registry of all cardiac pacemaker devices and pacemaker leads 
paid for by Medicare. This section requires doctors and 
hospitals receiving Medicare payments to provide information 
upon implementation, removal or replacement of pacemakers. 
Reports must be filed with two separate agencies, the Health 
Care Financing Administration and the Food and Drug 
Administration.

Explanation of provision

    The provision would repeal the cardiac pacemaker registry 
established by section 1862(h) (42 U.S.C. 1395y(h)).

Reason for change

    The Registry imposes an unnecessary burden on doctors and 
hospitals on reporting identical information to two separate 
agencies and the reporting is now redundant with passage of 
separate amendments to the Food, Drug and Cosmetic Act that 
established a more comprehensive reporting system on medical 
devices.

Effective date

    Upon enactment.

                      III. VOTES OF THE COMMITTEE

    In compliance with clause 2(l)(2)(B) of rule XI of the 
Rules of the House of Representatives, the following statement 
is made relative to the votes of the Committee in its 
consideration of the bill, H.R. 2366:

                       motion to report the bill

    The bill, H.R. 2366, was ordered favorably reported to the 
House, without amendment, by voice vote, with a quorum present.

                     IV. BUDGET EFFECTS OF THE BILL

               a. committee estimate of budgetary effects

    In compliance with clause 7(a) of rule XIII of the Rules of 
the House of Representatives, the following statement is made 
concerning the effects on the budget of this bill, H.R. 2366, 
as reported: The Committee agrees with the cost estimate 
furnished by the Congressional Budget Office which appears 
below.

    b. statement regarding 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.

      c. cost estimate prepared by the congressional budget office

    In compliance with subdivision (C) of clause 2(l)(3) of 
rule XI of the Rules of the House of Representatives, requiring 
a cost estimate prepared by the Congressional Budget Office 
(CBO), the following report prepared by CBO is provided:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, November 7, 1995.
Hon. Bill Archer,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office and the 
Joint Committee on Taxation (JCT) have reviewed H.R. 2494, as 
ordered reported by the House Committee on Ways and Means on 
November 1, 1995. The JCT estimates that this bill would 
increase receipts by $69 million in fiscal year 1996 and by 
$696 million over fiscal years 1996 through 2002. CBO concurs 
with the estimate.
    H.R. 2494 addresses the tax treatment of thrift 
institutions in two ways. First, the bill would repeal the 
reserve method of accounting allowed under section 593 of the 
Internal Revenue Code for the bad debts of thrifts. A thrift 
institution would be required to include in taxable income over 
a six-year period some portion of its post-1987 additions to 
its bad debt reserve. The inclusion in income would be 
suspended during years in which the institution made qualifying 
residential loans in excess of specified base amount. Second, 
the bill would provide that a special assessment paid by 
thrifts, established in H.R. 2491 (the ``Seven-Year Balanced 
Budget Reconciliation Act of 1995''), passed by the House of 
Representatives on October 26, 1995, would be allowed as a 
deduction in computing taxable income. No direct revenue effect 
is estimated for this second provision.
    CBO understands that the JCT estimate represents the 
effects of H.R. 2494 on governmental receipts (revenue) under 
the assumption that it is a stand-alone bill, as well as the 
combined effect on governmental receipts of H.R. 2494 and the 
thrift provisions of H.R. 2491. As discussed in my letter to 
Chairman Leach dated October 6, 1995, the reconciliation 
provisions of the House Committee on Banking and Financial 
Services, included in H.R. 2491, could cause many federal 
thrifts to reorganize as banks, which could affect future 
corporate income tax revenues. The JCT estimates, however, that 
any such effect from H.R. 2491 would be dominated by the effect 
of H.R. 2494 if it were included in H.R. 2491. The revenue 
effects of H.R. 2494 are summarized below:

                                          REVENUE EFFECTS OF H.R. 2494                                          
                                    [By fiscal year, in millions of dollars]                                    
----------------------------------------------------------------------------------------------------------------
                                                     1996     1997     1998     1999     2000     2001     2002 
----------------------------------------------------------------------------------------------------------------
Changes in Revenues..............................       69      106      103      105      106      107      100
----------------------------------------------------------------------------------------------------------------

    If you wish further details, please feel free to contact me 
or your staff may wish to contact Mark Booth.
            Sincerely,
                                              James L. Blum
                                   (For June E. O'Neill, Director).

     V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE

          a. committee oversight findings and recommendations

    With respect to subdivision (A) of clause 2(l)(3) of rule 
XI of the Rules of the House, the Committee advises that it was 
a result of the Committee's oversight activities concerning the 
Medicare program that the Committee concluded that it is 
appropriate to enact the provisions contained in the bill.

    b. summary of findings and recommendations of the committee on 
                    government reform and oversight

    With respect to subdivision (D) of clause 2(l)(3) of rule 
XI of the Rules of the House of Representatives (relating to 
oversight findings), the Committee advises that no oversight 
findings or recommendations have been submitted to this 
Committee by the Committee on Government Reform and Oversight 
with respect to the provisions contained in this bill.

                    c. inflationary impact statement

    In compliance with clause 2(l)(4) of rule XI of the Rules 
of the House of Representatives, the Committee states that the 
provisions of the bill are not expected to have an overall 
inflationary impact on prices or costs in the operation of the 
national economy.

       VI. 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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