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Subtitle H, Part 4
such as tables of terms, enrollment information, and
encounter data.
‘‘(2) COORDINATION OF BENEFITS.—The term
‘coordination of benefits’ means determining and co-
ordinating the financial obligations of health plans
when health care benefits are payable under such a
plan and under this title (including under a
MedicarePlus product).
‘‘(3) 
MEDICARE
INFORMATION.—The 
term
‘medicare information’ means any information that
relates to the enrollment of individuals under this
title (including information relating to elections of
MedicarePlus products under section 1805) and the
provision of health benefits (including benefits pro-
vided under such products) under this title.
‘‘(4) MEDICARE INFORMATION NETWORK.—The
term ‘medicare information network’ means the
medicare information system that is formed through
the application of the requirements and standards
established under this section.
‘‘(5) MEDICARE INFORMATION NETWORK SERV-
ICE.—The term ‘medicare information network serv-
ice’ means a public or private entity that—
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Subtitle H, Part 4
‘‘(A) processes or facilitates the processing
of nonstandard data elements of medicare infor-
mation into standard data elements;
‘‘(B) provides the means by which persons
may meet the requirements of this section; or
‘‘(C) provides specific information process-
ing services.
‘‘(6) HEALTH PLAN.—The term ‘health plan’
means a plan which provides, or pays the cost of,
health benefits. Such term includes the following, or
any combination thereof:
‘‘(A) Part A or part B of this title, and in-
cludes a MedicarePlus product.
‘‘(B) The medicaid program under title
XIX and the MediGrant program under title
XXI.
‘‘(C) A medicare supplemental policy (as
defined in section 1882(g)(1)).
‘‘(D) Worker’s compensation or similar in-
surance.
‘‘(E) Automobile or automobile medical-
payment insurance.
‘‘(F) A long-term care policy, other than a
fixed indemnity policy.
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Subtitle H, Part 4
‘‘(G) The Federal Employees Health Bene-
fit Plan under chapter 89 of title 5, United
States Code.
‘‘(H) An employee welfare benefit plan, as
defined in section 3(1) of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C.
1002(1)), but only to the extent the plan is es-
tablished or maintained for the purpose of pro-
viding health benefits.
‘‘(7) INDIVIDUALLY
IDENTIFIABLE
MEDICARE
INFORMATION.—The term ‘individually identifiable
medicare information’ means medicare enrollment
information, including demographic information col-
lected from an individual, that—
‘‘(A) is created or received by a health care
provider, health plan, employer, or medicare in-
formation network service, and
‘‘(B) identifies an individual.
‘‘(8) STANDARD SETTING ORGANIZATION.—The
term ‘standard setting organization’ means a stand-
ard setting organization accredited by the American
National Standards Institute.
‘‘(9) 
STANDARD
TRANSACTION.—The 
term
‘standard transaction’ means, when referring to an
information transaction or to data elements of medi-
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Subtitle H, Part 5
care information, any transaction that meets the re-
quirements and implementation specifications adopt-
ed by the Secretary under subsections (a) and (b).’’.
PART 5—OTHER PROVISIONS RELATING TO
PARTS A AND B
SEC. 15741. CLARIFICATION OF MEDICARE COVERAGE OF
ITEMS AND SERVICES ASSOCIATED WITH
CERTAIN MEDICAL DEVICES APPROVED FOR
INVESTIGATIONAL USE.
(a) COVERAGE.—Nothing in title XVIII of the Social
Security Act may be construed to prohibit coverage under
part A or part B of the medicare program of items and
services associated with the use of a medical device in the
furnishing of inpatient hospital services (as defined for
purposes of part A of the medicare program) solely on the
grounds that the device is not an approved device, if—
(1) the device is an investigational device; and
(2) the device is used instead of an approved
device.
(b) CLARIFICATION
OF PAYMENT AMOUNT.—Not-
withstanding any other provision of title XVIII of the So-
cial Security Act, the amount of payment made under the
medicare program for any item or service associated with
the use of an investigational device in the furnishing of
inpatient hospital services (as defined for purposes of part
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Subtitle H, Part 5
A of the medicare program) may not exceed the amount
of the payment which would have been made under the
program for the item or service if the item or service were
associated with the use of an approved device.
(c) DEFINITIONS.—In this section—
(1) the term ‘‘approved device’’ means a medi-
cal device which has been approved for marketing
under pre-market approval under the Federal Food,
Drug, and Cosmetic Act or cleared for marketing
under a 510(k) notice under such Act; and
(2) the term ‘‘investigational device’’ means a
medical device (other than a device described in
paragraph (1)) which is approved for investigational
use under section 520(g) of the Federal Food, Drug,
and Cosmetic Act.
SEC. 15742. ADDITIONAL EXCLUSION FROM COVERAGE.
(a) IN
GENERAL.—Section 1862(a) (42 U.S.C.
1395y(a)), as amended by section 15525(a)(2), section
15609B(a), and section 15701(c)(2)(C), is amended—
(1) by striking ‘‘or’’ at the end of paragraph
(17),
(2) by striking the period at the end of para-
graph (18) and inserting ‘‘; or’’, and
(3) by inserting after paragraph (18) the fol-
lowing new paragraph:
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Subtitle H, Part 5
‘‘(19) where such expenses are for items or
services, or to assist in the purchase, in whole or in
part, of health benefit coverage that includes items
or services, for the purpose of causing, or assisting
in causing, the death, suicide, euthanasia, or mercy
killing of a person.’’.
(b) EFFECTIVE DATE.—The amendments made by
subsection (a) shall apply to payment for items and serv-
ices furnished on or after the date of the enactment of
this Act.
SEC. 15743. COMPETITIVE BIDDING FOR CERTAIN ITEMS
AND SERVICES.
(a) ESTABLISHMENT
OF
DEMONSTRATION.—Not
later than 1 year after the date of the enactment of this
Act, the Secretary of Health and Human Services shall
establish and operate over a 2-year period a demonstration
project in 2 geographic regions selected by the Secretary
under which (notwithstanding any provision of title XVIII
of the Social Security Act to the contrary) the amount
of payment made under the medicare program for a se-
lected item or service (other than clinical diagnostic lab-
oratory tests) furnished in the region shall be equal to the
price determined pursuant to a competitive bidding proc-
ess which meets the requirements of subsection (b).
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Subtitle H, Part 5
(b) REQUIREMENTS
FOR COMPETITIVE BIDDING
PROCESS.—The competitive bidding process used under
the demonstration project under this section shall meet
such requirements as the Secretary may impose to ensure
the cost-effective delivery to medicare beneficiaries in the
project region of items and services of high quality.
(c) DETERMINATION OF SELECTED ITEMS OR SERV-
ICES.—The Secretary shall select items and services to be
subject to the demonstration project under this section if
the Secretary determines that the use of competitive bid-
ding with respect to the item or service under the project
will be appropriate and cost-effective. In determining the
items or services to be selected, the Secretary shall consult
with an advisory taskforce which includes representatives
of providers and suppliers of items and services (including
small business providers and suppliers) in each geographic
region in which the project will be effective.
SEC. 15744. DISCLOSURE OF CRIMINAL CONVICTIONS RE-
LATING TO PROVISION OF HOME HEALTH
SERVICES.
(a) 
IN
GENERAL.—Section 
1891 
(42 
U.S.C.
1395bbb) is amended by adding at the end the following
new subsection:
‘‘(g) The Secretary, and each State or local survey
agency or other State agency responsible for monitoring
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Subtitle H, Part 5
compliance of home health agencies with requirements,
shall make available, upon request of any person, informa-
tion the Secretary or agency has on individuals who have
been convicted of felonies relating to the provision of home
health services.’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) shall take effect on the date of the enact-
ment of this Act.
SEC. 15745. REQUIRING RENAL DIALYSIS FACILITIES TO
MAKE SERVICES AVAILABLE ON A 24-HOUR
BASIS.
(a) IN GENERAL.—Section 1881(b)(1) (42 U.S.C.
1395rr(b)(1)) is amended by striking the period at the end
and inserting the following: ‘‘, together with a requirement
(in the case of a renal dialysis facility) that the facility
make institutional dialysis services and supplies available
on a 24-hour basis (either directly or through arrange-
ments with providers of services or other renal dialysis fa-
cilities that meet the requirements of such subparagraph)
and that the facility provide notice informing its patients
of the other providers of services or renal dialysis facilities
(if any) with whom the facility has made such arrange-
ments.’’.
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Subtitle I
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) shall apply to items and services furnished
on or after January 1, 1996.
Subtitle I—Clinical Laboratories
SEC. 15801. EXEMPTION OF PHYSICIAN OFFICE LABORA-
TORIES.
Section 353(d) of the Public Health Service Act (42
U.S.C. 263a(d)) is amended—
(1) by redesignating paragraphs (2), (3), and
(4) as paragraphs (3), (4), and (5) and by adding
after paragraph (1) the following:
‘‘(2) EXEMPTION OF PHYSICIAN OFFICE LAB-
ORATORIES.—
‘‘(A) IN GENERAL.—Except as provided in
subparagraph (B), a clinical laboratory in a
physician’s office (including an office of a group
of physicians) which is directed by a physician
and in which examinations and procedures are
either performed by a physician or by individ-
uals supervised by a physician solely as an ad-
junct to other services provided by the physi-
cian’s office is exempt from this section.
‘‘(B) EXCEPTION.—A clinical laboratory
described in subparagraph (A) is not exempt
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Subtitle J
from this section when it performs a pap smear
(Papanicolaou Smear) analysis.
‘‘(C) DEFINITION.—For purposes of sub-
paragraph (A), the term ‘physician’ has the
same meaning as is prescribed for such term by
section 1861(r) of the Social Security Act (42
U.S.C. 1395x(r)).’’;
(2) in paragraph (3) (as so redesignated) by
striking ‘‘(3)’’ and inserting ‘‘(4)’’; and
(3) in paragraphs (4) and (5) (as so redesig-
nated) by striking ‘‘(2)’’ and inserting ‘‘(3)’’.
Subtitle 
J—Lock-Box 
Provisions
for Medicare Part B Savings
from Growth Reductions
SEC. 15901. ESTABLISHMENT OF MEDICARE GROWTH RE-
DUCTION TRUST FUND FOR PART B SAVINGS.
Part B of title XVIII is amended by inserting after
section 1841 the following new section:
‘‘MEDICARE GROWTH REDUCTION TRUST FUND
‘‘SEC. 1841A. (a)(1) There is hereby created on the
books of the Treasury of the United States a trust fund
to be known as the ‘Federal Medicare Growth Reduction
Trust Fund’ (in this section referred to as the ‘Trust
Fund’). The Trust Fund shall consist of such gifts and
bequests as may be made as provided in section 201(i)(1)
and amounts appropriated under paragraph (2).
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Subtitle J
‘‘(2) There are hereby appropriated to the Trust
Fund, out of any amounts in the Treasury not otherwise
appropriated, amounts equivalent to 100 percent of the
Secretary’s estimate of the reductions in outlays under
this part that are attributable to the Medicare Preserva-
tion Act of 1995. The amounts appropriated by the pre-
ceding sentence shall be transferred from time to time (not
less frequently than monthly) from the general fund in the
Treasury to the Trust Fund.
‘‘(3)(A) Subject to subparagraph (B), with respect to
monies transferred to the Trust Fund, no transfers, au-
thorizations of appropriations, or appropriations are per-
mitted.
‘‘(B) Beginning with fiscal year 2003, the Secretary
may expend funds in the Trust Fund to carry out this
title, but only to the extent provided by Congress in ad-
vance through a specific amendment to this section.
‘‘(b) The provisions of subsections (b) through (e) of
section 1841 shall apply to the Trust Fund in the same
manner as they apply to the Federal Supplementary Medi-
cal Insurance Trust Fund, except that the Board of Trust-
ees and Managing Trustee of the Trust Fund shall be
composed of the members of the Board of Trustees and
471
Subtitle J
the Managing Trustee, respectively, of the Federal Supple-
mentary Medical Insurance Trust Fund.’’.
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