I
106TH CONGRESS
2D SESSION
H. R. 4395
To amend title XVIII of the Social Security Act to improve the manner
in which new medical technologies are made available to Medicare bene-
ficiaries under the Medicare Program, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 8, 2000
Mr. RAMSTAD (for himself and Mrs. THURMAN) introduced the following bill;
which was referred to the Committee on Ways and Means, and in addi-
tion to the Committee on Commerce, for a period to be subsequently de-
termined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
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 Representa-
tives 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 de-
vices.
Sec. 5. Annual adjustments to medicare payment systems for changes in tech-
nology 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 modifica-
tions.
Sec. 11. Establishment of procedures for medicare coding and payment deter-
minations for new clinical diagnostic laboratory tests and other
items on a fee schedule.
SEC. 2. ANNUAL REPORTS ON NATIONAL COVERAGE DE-
TERMINATIONS.
(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 imple-
ment 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 com-
plete each significant step in the process of making such
determinations.
‘‘(B) the Secretary determines would present a
conflict of interest relating to such nonvoting mem-
ber.
‘‘(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 Sec-
retary without the prior approval of the advisory com-
mittee 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 So-
cial Security Act (42 U.S.C. 1395b–6(c)(2)(B)) is amend-
ed by inserting ‘‘individuals with national recognition for
their expertise in the development for market of new med-
ical items, services, and devices,’’ after ‘‘other health pro-
fessionals,’’.
(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
SYS-
TEMS FOR CHANGES IN TECHNOLOGY AND MEDICAL
PRACTICE
‘‘SEC. 1889. (a) IN GENERAL.—
‘‘(1) ASC, MFS, AND
INPATIENT
PPS.—Not-
withstanding 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 fac-
tors, diagnosis-related group classifications, and as-
signments to diagnosis-related groups) at least an-
nually 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 sys-
tems.
‘‘(2) OP PPS.—For a provision requiring ad-
justments to the elements of the outpatient prospec-
tive 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 sec-
tion 1833(i)(2)(A), section 1848(c)(2)(B), and section
1886(d)(4)(C) shall apply to the annual adjustments re-
quired 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 adjust-
ments 
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 representa-
tive 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 re-
quired 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 sec-
tion and section 1833(t)(9)(A), the Secretary shall
utilize data other than data collected by the Sec-
retary in the administration of the program estab-
lished under this title if—
‘‘(A) data collected by the Secretary in the
administration of such program are not avail-
able at the time such adjustments are being de-
termined; 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 iden-
tify or refine data collected by the
Secretary for use in making such an
adjustment; and
‘‘(II) are based on a representa-
tive sample of cases that is statis-
tically 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 DISCLO-
SURE OF PROTECTED HEALTH INFORMA-
TION.—Notwithstanding any other provi-
sion of law, individual authorization is not
required for disclosure of protected health
information to—
‘‘(I) a government agency or pri-
vate payer; or
‘‘(II) a private entity for the pur-
pose of disclosure to such an agency
or payer,
for inclusion in data systems of the agency
or payer for use in the formulation of cov-
erage, 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 de-
termining 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 tech-
nologies;
adjustments required by this section or section
1833(t)(9)(A). In no event may the deadline estab-
lished 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 pe-
riods beginning on or after October 1, 2001;
and
‘‘(B) be described in the proposed and
final rules published by the Secretary with re-
spect to changes to a payment system estab-
lished 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 sec-
tion, the term ‘provider payment update period’
means—
‘‘(A) in the case of the payment system es-
tablished under section 1833(i)(2)(A) or section
1848, a calendar year; and
‘‘(B) in the case of the payment system es-
tablished 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 in-
serting ‘‘Subject to section 1889, the’’.
(3) INPATIENT
HOSPITAL
PROSPECTIVE
PAY-
MENT
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 HOS-
PITAL OUTPATIENT SETTINGS.
(a) REPORT
BY SECRETARY
ON ACCESS
TO DE-
VICES.—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 begin-
ning with 2001, the Secretary shall submit to
Congress a report on access of individuals fur-
nished covered OPD services (as defined in
paragraph (1)(B)) to medical devices in con-
junction with such services. Such report shall
include an analysis of the impact of paragraph
(6)(A) in making new devices available in hos-
pital outpatient departments, the extent to
which barriers to such availability have been
overcome by reason of such paragraph, the im-
pact of including or excluding a device under
the payment system established by this sub-
section on beneficiary access to such device, and
a description of efforts by the Secretary to in-
crease the use and availability of such devices
in such departments. For purposes of this sub-
paragraph, 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 de-
vices 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 de-
vice 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 Se-
curity 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 para-
graph (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 cita-
tions 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 provi-
sion of title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.), the Secretary of Health and Human Serv-
ices 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 recommenda-
tions 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 pre-
ceding the last month of a calendar quarter into the
payment systems established under such title (in-
cluding the medicare fee schedule data base) not
later than the first day of the following calendar
quarter.
(b) ELIMINATION
OF
REQUIREMENT
FOR
MAR-
KETING EXPERIENCE.—Notwithstanding any other provi-
sion of title XVIII of the Social Security Act, the Sec-
retary 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 ap-
proval of a recommendation for an HCPCS level II modi-
fication 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 Admin-
istration 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 re-
port a detailed explanation of the reasons for such deter-
mination.
(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 sys-
tem 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 Ad-
ministration 
Common 
Procedure 
Coding 
System
(HCPCS).
SEC. 10. PROCESS FOR MAKING AND IMPLEMENTING ICD–
9–CM CODING MODIFICATIONS.
(a) IN GENERAL.—Notwithstanding any other provi-
sion of title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.), with respect to payments for inpatient hos-
pital 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 recommenda-
tions 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 pre-
ceding the last month of a calendar quarter into the
payment systems established under such title (in-
cluding the medicare fee schedule data base) not
later than the first day of the following calendar
quarter.
(b) ELIMINATION
OF
REQUIREMENT
FOR
MAR-
KETING EXPERIENCE.—Notwithstanding any other provi-
sion of title XVIII of the Social Security Act, the Sec-
retary 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 modi-
fication 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 Classifica-
tion of Diseases, 9th Revision, Clinical Modification, ap-
plied under such section 1886.
(d) MEDPAC REPORT.—Not later than January 1,
2001, the Medicare Payment Advisory Commission estab-
lished under section 1805 of the Social Security Act (42
U.S.C. 1395b–6) shall submit to Congress a report on—
(1) the procedures used by the Health Care Fi-
nancing Administration to makes changes to the
classification system, diagnosis-related groups, and
weighting factors established under paragraph (4) of
section 1886(d) of such Act (42 U.S.C. 1395ww(d))
to incorporate new technologies and respond to
changes in technology;
(2) whether such procedures ensure that the
payments made under the prospective payment sys-
tem established under such section are appropriate
and timely for new technologies and provide appro-
priate and timely recognition of changes in the tech-
nology; and
(3) recommendations for such legislation and
administrative actions as the Commission considers
appropriate to promote the appropriate and timely
incorporation of new technologies and the recogni-
tion of changes in technology under such system.
SEC. 11. ESTABLISHMENT OF PROCEDURES FOR MEDICARE
CODING AND PAYMENT DETERMINATIONS
FOR NEW CLINICAL DIAGNOSTIC LABORA-
TORY TESTS AND OTHER ITEMS ON A FEE
SCHEDULE.
(a) IN GENERAL.—Not later than one 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 following categories
of items and services under part B of the title XVIII of
the Social Security Act (42 U.S.C. 1395 et seq.): new clin-
ical diagnostic laboratory tests and durable medical equip-
ment. Such procedures (which may vary for the 2 cat-
egories of items and services referred to in the preceding
sentence) shall provide for the following:
(1) Such procedures shall be clearly under-
standable and follow a predictable format. Any hear-
ings or meetings with respect to the determinations