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H.R.5601
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act
of 2000 (Introduced in the House)
SEC. 522. REVISIONS TO MEDICARE COVERAGE PROCESS.
(a) REVIEW OF DETERMINATIONS- Section 1869 (42 U.S.C. 1395ff), as amended
by section 521, is further amended by adding at the end the following new
subsection:
`(h) REVIEW OF COVERAGE
DETERMINATIONS-
`(1) NATIONAL COVERAGE DETERMINATIONS-
`(A) IN GENERAL- Review of any national coverage determination shall be
subject to the following limitations:
`(i) Such a determination shall not be reviewed by any
administrative law judge.
`(ii) Such a determination shall not be held unlawful or set aside
on the ground that a requirement of section 553 of title 5, United
States Code, or section 1871(b) of this title, relating to publication
in the Federal Register or opportunity for public comment, was not
satisfied.
`(iii) Upon the filing of a complaint by an aggrieved party, the
Secretary shall provide for the review of a national coverage determination by the
advisory panel established pursuant to paragraph (3) (hereinafter
referred to as the `Panel'). In conducting such a review, the Panel
shall review the record to evaluate whether the determination is in
accord with sound medical
practice, taking into account medical , technological, or
clinical advancements, and any other medical , scientific, or other
relevant information that the Panel deems reliable and may consider
information that was not available or was not considered at the time of
the determination. The Panel shall make a recommendation to the
Secretary as to whether the determination should be upheld, modified, or
set aside, and the Secretary shall have 30 days from the receipt of such
recommendation to issue a decision.
`(iv) A decision of the Secretary under (h)(1)(A)(iii) constitutes a
final agency action and is subject to judicial review.
`(B) DEFINITION OF NATIONAL COVERAGE DETERMINATION- For
purposes of this section, the term `national coverage determination' means a
determination by the Secretary with respect to whether or not a particular
item or service is covered nationally under this title, but does not
include a determination of what code, if any, is assigned to a particular
item or service covered under this title or a determination with respect
to the amount of payment made for a particular item or service so
covered.
`(2) LOCAL COVERAGE
DETERMINATION-
`(A) Upon the filing of a complaint by an aggrieved party (except in
the cases of issues regarding the coding or supporting documentation), the
Secretary shall provide for the review of a local coverage determination by the
Panel as provided in (h)(3) except that for purposes of a review under
this subclause, the Panel shall also consider any special circumstances
that may be relevant to the practice of medicine in the locality. The
Panel shall make a recommendation to the Secretary as to whether the
determination should be upheld, modified, or set aside, and the Secretary
shall have 30 days from the receipt of such recommendation to issue a
decision to uphold the determination or to remand it to the fiscal
intermediary or carrier for revision. A fiscal intermediary or carrier
shall have 30 days from the receipt of any remand instructions from the
Secretary in which to complete such revision. The decision of the
Secretary shall have effect only with respect to the local coverage determination. Such a
decision constitutes a final agency action and is subject to judicial
review.
`(B) DEFINITION OF LOCAL COVERAGE DETERMINATION- For
purposes of this section, the term `local coverage determination' means a
determination by a fiscal intermediary or a carrier under part A or part
B, as applicable, respecting whether or not a particular item or service
is covered on an intermediary- or carrier-wide basis under such parts, in
accordance with section 1862(a)(1)(A).
`(3) ESTABLISHMENT OF MEDICAL ADVISORY PANEL- For the
purposes of providing expert clinical and scientific advice and
recommendations to the Secretary regarding reconsiderations of national or local coverage determinations under
paragraphs (1) and (2), the Secretary shall establish panels of experts or
use panels of experts (or members of such panels) established before the
date of enactment [insert name of Act] or both. The Secretary shall appoint
as members of any such panel persons the Secretary determines to have an
appropriate level of expertise in the subject matter, but shall not appoint
any individual who is in the regular full-time employ of the Health Care
Financing Administration or nay individual who participated in the initial
coverage determination that is
the subject of a reconsideration request.
`(4) PENDING NATIONAL
COVERAGE DETERMINATIONS-
`(A) IN GENERAL- In the event the Secretary has not issued a national coverage or noncoverage
determination with respect to a particular type or class of items or
services, an aggrieved person (as described in paragraph (5)) may submit
to the Secretary a request to make such a determination with respect to
such items or services. By not later than the end of the 90-day period
beginning on the date the Secretary receives such a request
(notwithstanding the receipt by the Secretary of new evidence (if any)
during such 90-day period), the Secretary shall take one of the following
actions:
`(i) Issue a national
coverage determination,
with or without limitations.
`(ii) Issue a national
noncoverage determination.
`(iii) Issue a determination that no national coverage or noncoverage
determination is appropriate as of the end of such 90-day period with
respect to national coverage of such items or
services.
`(iv) Issue a notice that states that the Secretary has not
completed a review of the request for a national coverage determination and that
includes an identification of the remaining steps in the Secretary's
review process and a deadline by which the Secretary will complete the
review and take an action described in subclause (I), (II), or
(III).
`(B) In the case of an action described in clause (i)(IV), if the
Secretary fails to take an action referred to in such clause by the
deadline specified by the Secretary under such clause, then the Secretary
is deemed to have taken an action described in clause (i)(III) as of the
deadline.
`(C) When issuing a determination under clause (i), the Secretary
shall include an explanation of the basis for the determination. An action
taken under clause (i) (other than subclause (IV)) is deemed to be a national coverage determination for
purposes of review under subparagraph (A).
`(5) STANDING- An action under this subsection seeking review of a national coverage determination or local
coverage determination may be
initiated only by individuals entitled to benefits under part A, or enrolled
under part B, or both, who are in need of the items or services that are the
subject of the coverage
determination.
`(6) PUBLICATION ON THE INTERNET OF DECISIONS OF HEARINGS OF THE
SECRETARY- Each decision of a hearing by the Secretary with respect to a
national coverage determination shall be made
public, and the Secretary shall publish each decision on the Medicare Internet site of the
Department of Health and Human Services. The Secretary shall remove from
such decision any information that would identify any individual, provider
of services, or supplier.
`(7) ANNUAL REPORT ON NATIONAL COVERAGE DETERMINATIONS-
`(A) IN GENERAL- Not later than December 1 of each year, beginning in
2001, the Secretary shall submit to Congress a report that sets forth a
detailed compilation of the actual time periods that were necessary to
complete and fully implement national coverage determinations that were
made in the previous fiscal year for items, services, or medical devices not previously
covered as a benefit under this title, including, with respect to each new
item, service, or medical
device, a statement of the time taken by the Secretary to make and
implement the necessary coverage , coding, and payment
determinations, including the time taken to complete each significant step
in the process of making and implementing such determinations.
`(B) PUBLICATION OF REPORTS ON THE INTERNET- The Secretary shall
publish each report submitted under clause (i) on the medicare Internet site of the
Department of Health and Human Services.
`(8) CONSTRUCTION- Nothing in this subsection shall be construed as
permitting administrative or judicial review pursuant to this section
insofar as such review is explicitly prohibited or restricted under another
provision of law.'.
(b) ESTABLISHMENT OF A PROCESS FOR COVERAGE DETERMINATIONS- Section
1862(a) (42 U.S.C. 1395y(a)) is amended by adding at the end the following new
sentence: `In making a national
coverage determination (as
defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure
that the public is afforded notice and opportunity to comment prior to
implementation by the Secretary of the determination; meetings of advisory
committees established under section 1114(f) with respect to the determination
are made on the record; in making the determination, the Secretary has
considered applicable information (including clinical experience and medical , technical, and scientific
evidence) with respect to the subject matter of the determination; and in the
determination, provide a clear statement of the basis for the determination
(including responses to comments received from the public), the assumptions
underlying that basis, and make available to the public the data (other than
proprietary data) considered in making the determination.
(c) IMPROVEMENTS TO THE MEDICARE ADVISORY COMMITTEE PROCESS-
Section 1114 (42 U.S.C. 1314) is amended by adding at the end the following
new subsection:
`(i)(1) Any advisory committee appointed under subsection (f) to advise
the Secretary on matters relating to the interpretation, application, or
implementation of section 1862(a)(1) shall assure the full participation of a
nonvoting member in the deliberations of the advisory committee, and shall
provide such nonvoting member access to all information and data made
available to voting members of the advisory committee, other than information
that--
`(A) is exempt from disclosure pursuant to subsection q(a) of section
552 of title 5, United States Code, by reason of subsection (b)(4) of such
section (relating to trade secrets); or
`(B) the Secretary determines would present a conflict of interest
relating to such nonvoting member.
`(2) If an advisory committee described in paragraph (1) organizes into
panels of experts according to types of items or services considered by the
advisory committee, any such panel of experts may report any recommendation
with respect to such items or services directly to the Secretary without the
prior approval of the advisory committee or an executive committee
thereof.'.
(d) EFFECTIVE DATE- The amendments made by this section apply with respect
to--
(1) a review of any national or local coverage determination filed,
(2) a request to make such a determination made,
(3) a national coverage determination made, on or
after October 1, 2001.
Subtitle D--Improving Access to New Technologies
SEC. 531. REIMBURSEMENT IMPROVEMENTS FOR NEW CLINICAL LABORATORY TESTS AND
DURABLE MEDICAL EQUIPMENT .
(a) PAYMENT RULE FOR NEW LABORATORY TESTS- Section 1833(h)(4)(B)(viii) (42
U.S.C. 1395l(h)(4)(B)(viii)) is amended by inserting before the period at the
end the following: `(or 100 percent of such median in the case of a clinical
diagnostic laboratory test performed on or after January 1, 2001, that the
Secretary determines is a new test for which no limitation amount has
previously been established under this subparagraph)'.
(b) ESTABLISHMENT OF CODING AND PAYMENT PROCEDURES FOR NEW CLINICAL
DIAGNOSTIC LABORATORY TESTS AND OTHER ITEMS ON A FEE SCHEDULE- Not later than
1 year after the date of the enactment of this Act, the Secretary of Health
and Human Services shall establish procedures for coding and payment
determinations for the categories of new clinical diagnostic laboratory tests
and new durable medical equipment under part B of the title
XVIII of the Social Security Act that permit public consultation in a manner
consistent with the procedures established for implementing coding
modifications for ICD-9-CM.
(c) REPORT ON PROCEDURES USED FOR ADVANCED, IMPROVED TECHNOLOGIES- Not
later than 1 year after the date of the enactment of this Act, the Secretary
of Health and Human Services shall submit to Congress a report that identifies
the specific procedures used by the Secretary under part B of title XVIII of
the Social Security Act to adjust payments for clinical diagnostic laboratory
tests and durable medical equipment which are classified to
existing codes where, because of an advance in technology with respect to the
test or equipment , there has
been a significant increase or decrease in the resources used in the test or
in the manufacture of the equipment , and there has been a
significant improvement in the performance of the test or equipment . The report shall include
such recommendations for changes in law as may be necessary to assure fair and
appropriate payment levels under such part for such improved tests and equipment as reflects increased costs
necessary to produce improved results.
SEC. 532. RETENTION OF HCPCS LEVEL III CODES.
(a) IN GENERAL- The Secretary of Health and Human Services shall maintain
and continue the use of level III codes of the HCPCS coding system (as such
system was in effect on August 16, 2000) through December 31, 2003, and shall
make such codes available to the public.
(b) DEFINITION- For purposes of this section, the term `HCPCS Level III
codes' means the alphanumeric codes for local use under the Health Care
Financing Administration Common Procedure Coding System (HCPCS).
SEC. 533. RECOGNITION OF NEW MEDICAL TECHNOLOGIES UNDER INPATIENT
HOSPITAL PPS.
(a) EXPEDITING RECOGNITION OF NEW TECHNOLOGIES INTO INPATIENT PPS CODING
SYSTEM-
(1) REPORT- Not later than April 1, 2001, the Secretary of Health and
Human Services shall submit to Congress a report on methods of expeditiously
incorporating new medical
services and technologies into the clinical coding system used with respect
to payment for inpatient hospital services furnished under the medicare program under title XVIII
of the Social Security Act, together with a detailed description of the
Secretary's preferred methods to achieve this purpose.
(2) IMPLEMENTATION- Not later than October 1, 2001, the Secretary shall
implement the preferred methods described in the report transmitted pursuant
to paragraph (1).
(b) ENSURING APPROPRIATE PAYMENTS FOR HOSPITALS INCORPORATING NEW MEDICAL SERVICES AND TECHNOLOGIES-
(1) ESTABLISHMENT OF MECHANISM- Section 1886(d)(5) (42 U.S.C.
1395ww(d)(5)) is amended by adding at the end the following new
subparagraphs:
`(K)(i) Effective for discharges beginning on or after October 1, 2001,
the Secretary shall establish a mechanism to recognize the costs of new medical services and technologies
under the payment system established under this subsection. Such mechanism
shall be established after notice and opportunity for public comment (in the
publications required by subsection (e)(5) for a fiscal year or otherwise).
`(ii) The mechanism established pursuant to clause (i) shall--
`(I) apply to a new medical service or technology if,
based on the estimated costs incurred with respect to discharges involving
such service or technology, the DRG prospective payment rate otherwise
applicable to such discharges under this subsection is inadequate;
`(II) provide for the collection of data with respect to the costs of a
new medical service or
technology described in subclause (I) for a period of not less than two
years and not more than three years beginning on the date on which an
inpatient hospital code is issued with respect to the service or
technology;
`(III) subject to paragraph (4)(C)(iii), provide for additional payment
to be made under this subsection with respect to discharges involving a new
medical service or technology
described in subclause (I) that occur during the period described in
subclause (II) in an amount that adequately reflects the estimated average
cost of such service or technology; and
`(IV) provide that discharges involving such a service or technology
that occur after the close of the period described in subclause (II) will be
classified within a new or existing diagnosis-related group with a weighting
factor under paragraph (4)(B) that is derived from cost data collected with
respect to discharges occurring during such period.
`(iii) For purposes of clause (ii)(II), the term `inpatient hospital code'
means any code that is used with respect to inpatient hospital services for
which payment may be made under this subsection and includes an alphanumeric
code issued under the International Classification of Diseases, 9th Revision,
Clinical Modification (`ICD-9-CM') and its subsequent revisions.
`(iv) For purposes of clause (ii)(III), the term `additional payment'
means, with respect to a discharge for a new medical service or technology
described in clause (ii)(I), an amount that exceeds the prospective payment
rate otherwise applicable under this subsection to discharges involving such
service or technology that would be made but for this subparagraph.
`(v) The requirement under clause (ii)(III) for an additional payment may
be satisfied by means of a new-technology group (described in subparagraph
(L)), an add-on payment, a payment adjustment, or any other similar mechanism
for increasing the amount otherwise payable with respect to a discharge under
this subsection. The Secretary may not establish a separate fee schedule for
such additional payment for such services and technologies, by utilizing a
methodology established under subsection (a) or (h) of section 1834 to
determine the amount of such additional payment, or by other similar
mechanisms or methodologies.
`(vi) For purposes of this subparagraph and subparagraph (L), a medical service or technology will be
considered a `new medical
service or technology' if the service or technology meets criteria established
by the Secretary after notice and an opportunity for public comment.
`(L)(i) In establishing the mechanism under subparagraph (K), the
Secretary may establish new-technology groups into which a new medical service or technology will be
classified if, based on the estimated average costs incurred with respect
to
discharges involving such service or technology, the DRG prospective payment
rate otherwise applicable to such discharges under this subsection is
inadequate.
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