Home > 106th Congressional Bills > S. 3083 (is) To enhance privacy and the protection of the public in the use of computers and the Internet, and for other purposes. [Introduced in Senate] ...S. 3083 (is) To enhance privacy and the protection of the public in the use of computers and the Internet, and for other purposes. [Introduced in Senate] ...
106th CONGRESS
2d Session
S. 3082
To amend title XVIII of the Social Security Act to improve the manner
in which new medical technologies are made available to Medicare
beneficiaries under the Medicare Program, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 20, 2000
Mr. Hatch introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to improve the manner
in which new medical technologies are made available to Medicare
beneficiaries under the Medicare Program, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medicare Access to
Technology Act of 2000''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Annual reports on national coverage determinations.
Sec. 3. Improvements to the medicare advisory committee process.
Sec. 4. Inclusion on MedPAC of an individual with expertise in new
medical devices.
Sec. 5. Annual adjustments to medicare payment systems for changes in
technology and medical practice.
Sec. 6. Annual reports on elimination of barriers to use of new medical
devices in hospital outpatient settings.
Sec. 7. Clarification of standard for coverage of drugs and
biologicals.
Sec. 8. Process for making and implementing HCPCS coding modifications.
Sec. 9. Retention of HCPCS level III codes.
Sec. 10. Process for making and implementing ICD-9-CM coding
modifications.
Sec. 11. Establishment of procedures for medicare coding and payment
determinations for new clinical diagnostic
laboratory tests and other items on a fee
schedule.
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.
``(B) Special rule.--
``(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)--
``(A) private payers;
``(B) manufacturers of medical technologies;
``(C) suppliers;
``(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)
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