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H.R.2030
Medicare Patient Access to Technology Act of 1999 (Introduced in the
House)
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) In order to assure genuine access of medicare beneficiaries to medical technologies, the Secretary
of Health and Human Services has an obligation to integrate and coordinate
its medical technology coverage policy determination
process with agency policies and practices that govern assignment of
procedure codes, establishment and adjustment of payment levels and
groupings, and issuance of timely instructions to contractors.
(2) The effectiveness of the medicare program in meeting
beneficiary needs is compromised if access to state-of-the-art medical care is denied as a result
of ineffective agency performance in the coverage , coding, or payment
processes, or in the ineffective administrative execution of medical technology decisions.
(3) The Secretary of Health and Human Services owes medicare beneficiaries the assurance
that the various medicare
payment systems (in both the fee-for-service and managed care areas) are
operated in a way that reflects developments in, and improvements upon,
medical technology by properly
setting and adjusting payment levels and payment groups.
(4) Clear, predictable, and well-functioning coverage , coding, and payment
systems are particularly critical to this country's small medical technology companies, which
are the originators of most medical product innovations.
(5) Unless medicare's
coverage , coding, and payment
systems review products promptly, apply standards appropriate for medical technology, and provide
reasonable reimbursement levels, these companies will experience
difficulties in bringing the benefits of medical innovation to medicare beneficiaries.
SEC. 3. ESTABLISHMENT OF MEDICARE ADVISORY COMMITTEES.
(a) IN GENERAL- Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended by adding at the end the following new section:
`MEDICARE ADVISORY
COMMITTEES
`SEC. 1897. (a) ESTABLISHMENT OF MEDICARE ADVISORY COMMITTEES- For the
purpose of securing advice and recommendations on issues related to coverage , payment, and coding
decisions, the Secretary shall establish, under section 9(a)(1) of the Federal
Advisory Committee Act, the advisory committees described in this section.
`(b) MEDICARE PAYMENT AND
CODING ADVISORY COMMITTEE-
`(1) ESTABLISHMENT- For the purpose of securing advice and
recommendations on payment and coding issues under this title, not later
than January 1, 2000, the Secretary shall establish the Medicare Payment and Coding Advisory
Committee (hereinafter in this subsection referred to as the `Committee').
The Secretary shall consult with the Committee, and may consult directly
with any panel of the Committee established pursuant to subsection
(d)(1).
`(2) DUTIES- The Committee, and its panels, shall provide advice and
recommendations to the Secretary on policies regarding payment and coding
issues under this title, including identification of--
`(A) policies and mechanisms to help ensure that payment and coding
decisions are--
`(i) made in a way that encourages access to high-quality medical care under this
title;
`(ii) made through processes that allow for significant public
participation; and
`(iii) made expeditiously, in accordance with specified time frames
for each significant step in the process of making such
decisions;
`(B) an equitable mechanism for determining fee schedule payment
amounts for items and services (other than physicians' services);
and
`(C) processes for reconsideration and appeal of determinations of fee
schedule payment amounts.
`(A) ANNUAL REPORT TO THE SECRETARY- Not later than December 1 of each
of fiscal years 2000 through 2003, the Committee shall submit to the
Secretary a report on the progress of the Committee progress during the
preceding fiscal year, in carrying out the duties under paragraph
(2).
`(B) PUBLICATION OF REPORT- Not later than 60 days after receipt of
the report under subparagraph (A), the Secretary shall publish the report,
together with any supplemental views of the Secretary, on the Internet
site of the Department of Health and Human Services.
`(4) TERMINATION- The Committee shall terminate on September 30,
2003.
`(c) ADVISORY COMMITTEE ON MEDICARE ACCESS TO TECHNOLOGY-
`(1) ESTABLISHMENT- Not later than July 1, 2003, the Secretary shall
establish the Medicare Access
to Technology Advisory Committee (hereinafter in this subsection referred to
as the `Committee'). The Secretary shall consult with the Committee, and may
consult directly with any panel of the Committee established pursuant to
subsection (d)(1).
`(2) DUTIES- The Committee, and its panels, shall provide advice and
recommendations to the Secretary with respect to--
`(A) the issues referred to the Medicare Coverage Advisory Committee
(established by the Secretary on November 24, 1998, notice of which was
printed in the Federal Register on December 14, 1998, (63 FR
68780));
`(B) the issues referred to the Medicare Payment and Coding
Advisory Committee under subsection (b); and
`(C) integrating policies on coverage , payment, and coding
under this title into a process that helps to assure timely access to
high-quality medical
care.
`(A) ANNUAL REPORT TO THE SECRETARY- Not later than December 1 of
every year beginning with 2004, the Committee shall submit to the
Secretary a report on the progress of the Committee during the preceding
fiscal year, in accomplishing the duty described in paragraph
(2)(C).
`(B) PUBLICATION OF REPORT- Not later than 60 days after receipt of
the report under subparagraph (A), the Secretary shall publish the report,
together with any supplemental views of the Secretary, on the Internet
site of the Department of Health and Human Services.
`(4) DURATION- Section 14(a)(2)(B) of the Federal Advisory Committee Act
(5 U.S.C. App.; relating to the termination of advisory committees) shall
not apply to the Committee.
`(d) ADVISORY COMMITTEE PROCEDURES- In administering each of the advisory
committees under this section, the Secretary shall--
`(1) organize each advisory committee into panels of experts according
to types of items or services;
`(2) solicit nominations as needed from the public by publishing a
notice in the Federal Register and on the Internet site of the Department of
Health and Human Services;
`(3) ensure participation on each advisory committee of persons
who--
`(A) are experts in a variety of medical specialties and fields of
science, in specific areas of medical technology (such as
clinical and diagnostic tests and durable medical equipment ), in medical research generally (such
as the study of treatment outcomes), and in other areas relevant to the
duties assigned to the advisory committee (taking into account, as
appropriate, any affiliations individuals may have with organizations
possessing information, expertise, and other resources that would
contribute significantly to the work of the advisory committee and its
panels);
`(B) are qualified by training and experience to evaluate the matters
referred to the advisory committee (including, on each panel, a
representative of consumer interests and a representative of the interests
of manufacturers of medical
technology); and
`(C) have adequately diversified backgrounds so that the advisory
committee will provide balanced advice and recommendations;
`(4) exclude from membership on each advisory committee individuals who
are in the full time employ of the United States and engaged in the
administration of the program established under this title;
`(5) limit the number of members of each advisory committee who are
otherwise in the full-time employ of the United States to not more than 10
percent of the total membership of the advisory committee;
`(6) impose appropriate term limits for members of each advisory
committee;
`(7) designate one of the members of each panel to serve as the chair
thereof and appoint an executive subcommittee comprised of the chairs of
each panel to advise the Secretary regarding--
`(A) establishing priorities; and
`(B) referring issues to appropriate panels;
`(8) permit each panel to independently advise the Secretary with regard
to matters referred to the
panel, without the need to obtain the concurrence of the full advisory
committee;
`(9) provide for appropriate consultation with outside experts by each
advisory committee and its panels;
`(A) full public participation, to the extent required or permitted
under law, in any meeting of each advisory committee or its
panels;
`(B) at least 60 days' advance notice on the Internet site of the
Department of Health and Human Services of any such meeting, including a
statement of the issues to be considered by the advisory committee or
panel, a description of the specific information that is relevant to such
issues, and the text of any proposals the Secretary will ask the advisory
committee or panel to consider;
`(C) consideration by each advisory committee or panel of relevant
information or testimony that is submitted by the public; and
`(D) public access in a central repository to the information
described in subparagraph (C) at least 20 days before the
meeting;
`(11) furnish each advisory committee and its panels with adequate
clerical and other necessary assistance;
`(12) provide for the compensation of members of each advisory committee
and its panels (other than those in the full time employ of the United
States)--
`(A) while attending meetings or otherwise engaged in official
business at rates to be fixed by the Secretary, but not at rates exceeding
the daily equivalent of the rate in effect for level IV of the Executive
Schedule for each day so engaged, including travel time; and
`(B) while serving away from their homes or regular places of
business, of travel expenses (including per diem in lieu of subsistence)
as authorized by section 5703 of Title 5, United States Code, for persons
in the Government service employed intermittently;
`(13) provide for the panels to meet at least once every 3 months unless
there is no business to conduct;
`(14) require each advisory committee and its panels to provide, with
any recommendation, a summary of the reasons for the recommendation and a
summary of the data upon which the recommendation is based;
`(15) make a verbatim transcript of each advisory committee and panel
proceedings (other than those portions that are closed to the public in
accordance with law) available to the public within 14 days on an official
Internet site of the Department of Health and Human Services; and
`(16) prescribe in regulations the procedures to be followed by each
advisory committee and its panels in making their reviews and
recommendations.
`(e) DEFINITIONS- For purposes of this section--
`(1) the term `coding' means the assignment of identification codes for
medical equipment and supplies, items,
services, and other benefits under this title; and
`(2) the term `payment' means the determination of appropriate payment
amounts for medical equipment and supplies, items,
services, and other benefits under this title.'.
(b) TRANSITION, CONTINUING RESPONSIBILITY FOR UNFINISHED DUTIES-
(1) Effective on the date the Medicare Access to Technology
Advisory Committee is established, the Secretary of Health and Human
Services shall provide for the transfer to such committee of any assets and
staff of the Medicare Coverage Advisory Committee and the
Medicare Payment and Coding
Advisory Committee, without any loss of benefits or seniority by virtue of
such transfers. Fund balances available to the Medicare Coverage Advisory Committee or the
Medicare Payment and Coding
Advisory Committee for any period shall be available to the Medicare Access to Technology
Advisory Committee for such period for like purposes.
(2) The Medicare Access to
Technology Advisory Committee shall be responsible for the preparation and
submission of reports and recommendations not yet submitted to the Secretary
by the Medicare Coverage Advisory Committee or the
Medicare Payment and Coding
Advisory Committee upon the expiration of those committees.
(c) REPORTING REQUIREMENTS-
(1) Not later than April 1, 2000, the Secretary of Health and Human
Services shall submit to Congress a report certifying that the committee and
panels required to be established by section 1897(b), as added by subsection
(a), are operational.
(2) Not later than September 1, 2003, the Secretary of Health and Human
Services shall submit to Congress a report certifying that the committee and
panels required to be established by section 1897(c), as added by subsection
(a), are operational.
(3) Not later than December 1 of each year beginning with 2000, the
Secretary of Health and Human Services shall submit to Congress a report
describing the timeliness of the Secretary's national coverage policy decision making
during the preceding fiscal year measured by the time frames the Secretary
has published for the national
coverage policy determination
process, and such report shall include the actual time periods that were
necessary to complete and fully implement national coverage policy determinations and
each significant step in the process.
(4) Not later than July 1, 2000, the Secretary of Health and Human
Services shall submit to Congress a report, on the nature of the coverage policy determination
processes used by Medicare
+Choice organizations, under part C of title XVIII of the Social Security
Act, including a detailed explanation of any steps taken to ensure that the
coverage policy determination
processes under the Medicare
+Choice program--
(A) produce results consistent with the coverage policy determinations
reached under parts A and B of such title; and
(B) treat any medical
device being investigated under section 520(g) of the Federal Food, Drug,
and Cosmetic Act (42 U.S.C. 360j(g)), in a manner consistent with the
treatment afforded such medical device under such
parts.
SEC. 4. ANNUAL ADJUSTMENTS TO MEDICARE PAYMENT SYSTEMS FOR CHANGES IN
TECHNOLOGY AND MEDICAL
PRACTICE.
(a) IN GENERAL- Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended by inserting after section 1888 the following new section:
`ANNUAL ADJUSTMENTS TO MEDICARE PAYMENT SYSTEMS FOR CHANGES IN
TECHNOLOGY AND MEDICAL
PRACTICE
`SEC. 1889. (a) IN GENERAL- Notwithstanding any other provision of this
title, the Secretary shall adjust the appropriate elements of the payment
systems established under sections 1833(i)(2)(A), 1833(t), 1848, and 1886(d),
and the payment systems referred to in subsection (f), (including relative
payment weights, relative value units, and weighting factors) at least
annually to ensure that payments under such systems--
`(1) appropriately reflect changes in medical technology and medical practice affecting the items
and services for which payment may be made under such systems; and
`(2) promote the efficient and effective delivery of high-quality health
care.
`(b) RULES FOR DETERMINING ADJUSTMENTS- Except as provided in subsection
(c), the provisions of section 1833(i)(2)(A), section 1833(t)(6), section
1848(c)(2)(B), and section 1886(d)(4)(C), and the appropriate provisions of
the payments systems referred to in subsection (f), shall apply to the annual
adjustments required by this section in the same manner and to the same extent
as they apply to the periodic adjustments of relative payment weights,
relative value units, and weighting factors, respectively, that are authorized
or required by such sections.
`(c) USE OF INTERNAL DATA COLLECTED BY THE SECRETARY-
`(1) IN GENERAL- In determining the adjustments required by this
subsection, the Secretary may not--
`(A) decline to make an adjustment that is based on data collected by
the Secretary in the administration of the program established under this
title if the data reflect a representative sample of cases that is
statistically valid; and
`(B) establish a uniform period of time (such as one year) from which
such data must be drawn.
`(2) DEADLINE FOR SUPPLYING INTERNAL DATA- The Secretary shall establish
a reasonable deadline for the submission of data collected by the Secretary
to be used in making the adjustments required by this section. In no event
may the deadline established under this paragraph be more than 7 months
before the first day of the provider payment update period for which the
adjustment or adjustments to which the data relates would be
effective.
`(d) USE OF EXTERNAL DATA-
`(1) IN GENERAL- Subject to paragraph (2), in determining the
adjustments required by this section, the Secretary shall utilize data other
than data collected by the Secretary in the administration of the program
established under this title if--
`(A) data collected by the Secretary in the administration of such
program are not available at the time such adjustments are being
determined; and
`(B) such other data are reliable and verifiable.
`(2) EXTERNAL DATA FACILITATING THE USE OF INTERNAL DATA- In determining
the adjustments required by this section, the Secretary may not--
`(A) decline to use data other than data collected by the Secretary if
such other data--
`(i) enable the Secretary to identify or refine data collected by
the Secretary for use in making such an adjustment; and
`(ii) are based on a representative sample of cases that is
statistically valid; or
`(B) establish a uniform period of time (such as one year) from which
such data must be drawn.
`(3) ALTERNATIVE SOURCES OF DATA- In determining the adjustments
required by this section, the Secretary shall use data, that otherwise meets
the requirements of this subsection, collected by (or on behalf of)--
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