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S.3082
Medicare Access to Technology Act of 2000 (Introduced in the
Senate)
SEC. 2. ANNUAL REPORTS ON NATIONAL COVERAGE DETERMINATIONS.
(a) ANNUAL REPORTS- Not later than December 1 of each year, beginning in
2001, the Secretary of Health and Human Services 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 any national coverage determinations that were made
in the previous fiscal year for items, services, or medical devices not previously covered
as a benefit under title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.), including, with respect to each new item, service, or medical device, a statement of the
time taken by the Secretary to make the necessary coverage , coding, and payment
determinations, including the time taken to complete each significant step in
the process of making such determinations.
(b) PUBLICATION OF REPORTS ON THE INTERNET- The Secretary of Health and
Human Services shall publish each report submitted under subsection (a) on the
medicare Internet site of the
Department of Health and Human Services.
SEC. 3. IMPROVEMENTS TO THE MEDICARE ADVISORY COMMITTEE
PROCESS.
Section 1114 of the Social Security Act (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 (a) of section 552
of title 5, United States Code, by reason of subsection (b)(4) of such
section (relating to trade secrets); and
`(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.'.
SEC. 4. INCLUSION ON MEDPAC OF AN INDIVIDUAL WITH EXPERTISE IN NEW MEDICAL DEVICES.
(a) IN GENERAL- Section 1805(c)(2)(B) of the Social Security Act (42
U.S.C. 1395b-6(c)(2)(B)) is amended by inserting `individuals with national recognition for their
expertise in the development for market of new medical items, services, and devices,'
after `other health professionals,'.
(b) EFFECTIVE DATE- The amendment made by subsection (a) applies with
respect to members appointed to the Medicare Payment Advisory Commission
on or after the date of the enactment of this Act.
SEC. 5. 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-
`(1) ASC, MFS, AND INPATIENT PPS- 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), 1848, and 1886(d)
(including relative payment weights, relative value units, weighting
factors, diagnosis-related group classifications, and assignments to
diagnosis-related groups) at least annually to ensure that payments under
such systems appropriately reflect changes in medical technology and medical practice affecting the items
and services for which payment may be made under such systems.
`(2) OP PPS- For a provision requiring adjustments to the elements of
the outpatient prospective payment system at least annually, see section
1833(t)(9)(A).
`(b) RULES FOR DETERMINING ADJUSTMENTS- Except as provided in subsection
(c), the provisions of section 1833(i)(2)(A), section 1848(c)(2)(B), and
section 1886(d)(4)(C) 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,
weighting factors, diagnosis-related group classifications, and assignments to
diagnosis-related groups, 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 section
and section 1833(t)(9)(A), 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 or section
1833(t)(9)(A). In no event may the deadline established under this paragraph
be more than seven months before the first day of the provider payment
update period for which the adjustment or adjustments to which the data
relate would be effective.
`(d) USE OF EXTERNAL DATA-
`(1) IN GENERAL- Subject to paragraph (2), in determining the
adjustments required by this section and section 1833(t)(9)(A), 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-
`(A) IN GENERAL- In determining the adjustments required by this
section and section 1833(t)(9)(A), the Secretary may not--
`(i) 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
`(ii) establish a uniform period of time (such as one year) from
which such data must be drawn.
`(i) WAIVER OF REQUIREMENT FOR INDIVIDUAL AUTHORIZATION FOR
DISCLOSURE OF PROTECTED HEALTH INFORMATION- Notwithstanding any other
provision of law, individual authorization is not required for
disclosure of protected health information to--
`(I) a government agency or private payer; or
`(II) a private entity for the purpose of disclosure to such an
agency or payer,
for inclusion in data systems of the agency or payer for use in the
formulation of coverage ,
coding, and payment policies of the agency or payer.
`(ii) CONSTRUCTION- Nothing in clause (i) shall be construed as
authorizing the disclosure or use of such information by such an agency,
payer, or entity for any other purpose.
`(3) ALTERNATIVE SOURCES OF DATA- In determining the adjustments
required by this section and section 1833(t)(9)(A), the Secretary shall use
data, that otherwise meet the requirements of this subsection, collected by
(or on behalf of)--
`(B) manufacturers of medical technologies;
`(D) groups representing physicians and other health care
professionals;
`(E) groups representing providers;
`(F) clinical trials; and
`(G) such other sources as the Secretary determines to be
appropriate.
`(4) CLARIFICATION- Nothing in this title shall be construed as--
`(A) requiring the Secretary to identify all claims submitted under a
payment system established under section 1833(i)(2)(A), section 1833(t),
section 1848, or section 1886(d) involving the use of a medical technology before the
Secretary may make the adjustments under this section (or under section
1833(i)(2)(A), section 1833(t), section 1848, or section 1886(d)) with
respect to such technology; or
`(B) authorizing the Secretary to defer action on such an adjustment
until all such claims are identifiable.
`(5) DEADLINE FOR SUPPLYING EXTERNAL DATA- The Secretary shall establish
a reasonable deadline for the submission of data other than data collected
by the Secretary to be used in making the adjustments required by this
section or section 1833(t)(9)(A). In no event may the deadline established
under this paragraph be more than 9 months before the first day of the
provider payment update period for which the adjustment or adjustments to
which the data relate would be effective.
`(e) TIMING OF ADJUSTMENTS-
`(1) IN GENERAL- The annual adjustments required by this section
shall--
`(A) apply to provider payment update periods beginning on or after
October 1, 2001; and
`(B) be described in the proposed and final rules published by the
Secretary with respect to changes to a payment system established under
section 1833(i)(2)(A), 1848, or 1886(d) for the provider payment update
period to which they relate, together with a description of the data on
which such adjustments are based.
`(2) DEFINITION- For purposes of this section, the term `provider
payment update period' means--
`(A) in the case of the payment system established under section
1833(i)(2)(A) or section 1848, a calendar year; and
`(B) in the case of the payment system established under section
1886(d), a fiscal year beginning on October 1.'.
(b) CONFORMING AMENDMENTS-
(1) AMBULATORY SURGICAL CENTERS- Section 1833(i)(2)(A) of the Social
Security Act (42 U.S.C. 1395l(i)(2)(A)) is amended by striking `Each' in the
second sentence thereof and inserting `Subject to section 1889, each'.
(2) PHYSICIAN PAYMENT- Section 1848(c)(2)(B)(i) of such Act (42 U.S.C.
1395w-4(c)(2)(B)(i)) is amended by striking `The' and inserting `Subject to
section 1889, the'.
(3) INPATIENT HOSPITAL PROSPECTIVE PAYMENT SYSTEM- Section
1886(d)(4)(C)(i) of such Act (42 U.S.C. 1395ww(d)(4)(C)(i)) is amended by
striking `The' and inserting `Subject to section 1889, the'.
SEC. 6. ANNUAL REPORTS ON ELIMINATION OF BARRIERS TO USE OF NEW MEDICAL DEVICES IN HOSPITAL OUTPATIENT
SETTINGS.
(a) REPORT BY SECRETARY ON ACCESS TO DEVICES- Section 1833(t)(13) of the
Social Security Act (42 U.S.C. 1395l(t)(13)) is amended by adding at the end
the following new subparagraph:
`(B) REPORT ON ACCESS TO DEVICES- Not later than December 1 of each
year beginning with 2001, the Secretary shall submit to Congress a report
on access of individuals furnished covered OPD services (as defined in
paragraph (1)(B)) to medical
devices in conjunction with such services. Such report shall include an
analysis of the impact of paragraph (6)(A) in making new devices available
in hospital outpatient departments, the extent to which barriers to such
availability have been overcome by reason of such paragraph, the impact of
including or excluding a device under the payment system established by
this subsection on beneficiary access to such device, and a description of
efforts by the Secretary to increase the use and availability of such
devices in such departments. For purposes of this subparagraph, the term
`device' means any item that is treated as a device under section 201(h)
of the Federal Food, Drug, and Cosmetic Act.'.
(b) MEDPAC REPORT ON NEW DEVICES- Section 1805(b)(2)(C) of the Social
Security Act (42 U.S.C. 1395b-6(b)(2)(C)) is amended by adding at the end the
following: `In conducting such review, the Commission shall monitor medicare beneficiary access to medical devices for which payment is
made under section 1833(t) in hospital outpatient departments, shall assess
the impact of paragraph (6)(A) of such section in making new devices available
in such departments, the extent to which barriers to such availability have
been overcome by reason of such paragraph, and the impact of including or
excluding a device under the payment system established by section 1833(t) on
beneficiary access to such device, and shall make any recommendations the
Commission determines would increase availability of such devices to
individuals entitled to benefits under this title. For purposes of this
subparagraph, the term `device' means any item that is treated as a device
under section 201(h) of the Federal Food, Drug, and Cosmetic Act.'.
SEC. 7. CLARIFICATION OF STANDARD FOR COVERAGE OF DRUGS AND BIOLOGICALS.
(a) IN GENERAL- Section 1862(a) of the Social Security Act (42 U.S.C.
1395y(a)) is amended by adding at
the end the following: `A drug or biological may not be excluded from coverage under this title by reason of
paragraph (1)(A) if the drug or biological has been approved by the Food and
Drug Administration and is prescribed for a use that has been approved by the
Food and Drug Administration or that is supported by one or more citations that
are included (or approved for inclusion) in one or more of the compendia
referred to in section 1861(t)(2)(B)(ii)(I).'.
(b) EFFECTIVE DATE- The amendment made by subsection (a) shall apply to
coverage determinations made on
or after the date of enactment of this Act.
SEC. 8. PROCESS FOR MAKING AND IMPLEMENTING HCPCS CODING MODIFICATIONS.
(a) IN GENERAL- Notwithstanding any other provision of title XVIII of the
Social Security Act (42 U.S.C. 1395 et seq.), the Secretary of Health and
Human Services shall--
(1) not later than 30 days after the receipt of a written request of a
product sponsor, assign a temporary code to a drug or device reviewed by the
Food and Drug Administration;
(2) accept recommendations for HCPCS level II code modifications from
the public throughout the year;
(3) cause determinations on such recommendations to be made within 30
days after receipt of the recommendation; and
(4) incorporate modifications to HCPCS level II codes that are approved
during the 3 months preceding the last month of a calendar quarter into the
payment systems established under such title (including the medicare fee schedule data base) not
later than the first day of the following calendar quarter.
(b) ELIMINATION OF REQUIREMENT FOR MARKETING EXPERIENCE- Notwithstanding
any other provision of title XVIII of the Social Security Act, the Secretary
of Health and Human Services may not require a minimum period of marketing
experience with respect to a drug or device as a condition of consideration or
approval of a recommendation for an HCPCS level II modification for such drug
or device.
(c) DEFINITION- For purposes of this section, the term `HCPCS level II
code modification' means any change to the alphanumeric codes for items not
included in level I or level III of the Health Care Financing Administration
Common Procedure Coding System (HCPCS).
(d) REPORT- Not later than 180 days after the date of the enactment of
this Act, the Secretary of Health and Human Services shall submit to Congress
a report on the feasibility and desirability of opening meetings of the
Alpha-Numeric Editorial Panel of the Department of Health and Human Services
to the public. If the Secretary determines that opening such meetings to the
public is not feasible or desirable, the Secretary shall include in the report
a detailed explanation of the reasons for such determination.
(e) EFFECTIVE DATE- The provisions of this section take effect on January
1, 2001.
SEC. 9. 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 June 1, 1999), 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. 10. PROCESS FOR MAKING AND IMPLEMENTING ICD-9-CM CODING
MODIFICATIONS.
(a) IN GENERAL- Notwithstanding any other provision of title XVIII of the
Social Security Act (42 U.S.C. 1395 et seq.), with respect to payments for
inpatient hospital services under section 1886 of such Act (42 U.S.C. 1395ww),
the Secretary of Health and Human Services shall--
(1) not later than 30 days after the receipt of a written request of a
product sponsor, assign a temporary code to a drug or device reviewed by the
Food and Drug Administration;
(2) accept recommendations for ICD-9-CM code modifications from the
public throughout the year;
(3) cause determinations on such recommendations to be made within 30
days after receipt of the recommendation; and
(4) incorporate modifications to ICD-9-CM codes that are approved during
the 3 months preceding the last month of a calendar quarter into the payment
systems established under such title (including the medicare fee schedule data base) not
later than the first day of the following calendar quarter.
(b) ELIMINATION OF REQUIREMENT FOR MARKETING EXPERIENCE- Notwithstanding
any other provision of title XVIII of the Social Security Act, the Secretary
of Health and Human Services may not require a
minimum period of marketing experience with respect to an item, service, or
device for which payment is made under such section 1886 as a condition of
consideration or approval of a recommendation for an ICD-9-CM modification for
such item, service, or device.
(c) DEFINITION- For purposes of this section, the term `ICD-9-CM code
modification' means any change to the alphanumeric codes of the International
Classification of Diseases, 9th Revision, Clinical Modification, applied under
such section 1886.
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