H. R. 2015—209
‘‘(iii) conditions of participation for suppliers in
the billing arrangement;
‘‘(iv) sanctions of suppliers who are determined
to engage in coercive or abusive practices, including
exclusion; and
‘‘(v) such other safeguards as the Secretary deter-
mines are necessary.’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph
(1) shall apply to purchases or rentals after the effective date
of any regulations issued pursuant to such amendment.
SEC. 4552. OXYGEN AND OXYGEN EQUIPMENT.
(a) 
IN
GENERAL.—Section 
1834(a)(9)(B) 
(42 
U.S.C.
1395m(a)(9)(B)) is amended—
(1) in clause (iii), by striking ‘‘and’’ at the end;
(2) in clause (iv)—
(A) by striking ‘‘each subsequent year’’ and inserting
‘‘1995, 1996, and 1997’’, and
(B) by striking the period at the end and inserting
a semicolon; and
(3) by adding at the end the following new clauses:
‘‘(v) for 1998, 75 percent of the amount determined
under this subparagraph for 1997; and
‘‘(vi) for 1999 and each subsequent year, 70 percent
of the amount determined under this subparagraph
for 1997.’’.
(b) ESTABLISHMENT
OF
CLASSES
FOR
PAYMENT.—Section
1848(a)(9) (42 U.S.C. 1395m(a)(9)) is amended by adding at the
end the following new subparagraph:
‘‘(D) AUTHORITY TO CREATE CLASSES.—
‘‘(i) IN GENERAL.—Subject to clause (ii), the Sec-
retary may establish separate classes for any item
of oxygen and oxygen equipment and separate national
limited monthly payment rates for each of such classes.
‘‘(ii) BUDGET
NEUTRALITY.—The Secretary may
take actions under clause (i) only to the extent such
actions do not result in expenditures for any year
to be more or less than the expenditures which would
have been made if such actions had not been taken.’’.
(c) STANDARDS.—The Secretary shall as soon as practicable
establish service standards for persons seeking payment under part
B of title XVIII of the Social Security Act for the providing of
oxygen and oxygen equipment to beneficiaries within their homes.
(d) ACCESS TO HOME OXYGEN EQUIPMENT.—
(1) STUDY.—The Comptroller General of the United States
shall study issues relating to access to home oxygen equipment
and shall, within 18 months after the date of the enactment
of this Act, report to the Committees on Commerce and Ways
and Means of the House of Representatives and the Committee
on Finance of the Senate the results of the study, including
recommendations (if any) for legislation.
(2) PEER REVIEW EVALUATION.—The Secretary of Health
and Human Services shall arrange for peer review organiza-
tions established under section 1154 of the Social Security
Act to evaluate access to, and quality of, home oxygen equip-
ment.
(e) EFFECTIVE DATE.—
H. R. 2015—210
(1) OXYGEN.—The amendments made by subsection (a)
shall apply to items furnished on and after January 1, 1998.
(2) OTHER
PROVISIONS.—The amendments made by this
section other than subsection (a) shall take effect on the date
of the enactment of this Act.
SEC. 4553. REDUCTION IN UPDATES TO PAYMENT AMOUNTS FOR CLINI-
CAL DIAGNOSTIC LABORATORY TESTS; STUDY ON LAB-
ORATORY TESTS.
(a) CHANGE IN UPDATE.—Section 1833(h)(2)(A)(ii)(IV) (42 U.S.C.
1395l(h)(2)(A)(ii)(IV)) is amended by inserting ‘‘and 1998 through
2002’’ after ‘‘1995’’.
(b) 
LOWERING
CAP
ON
PAYMENT
AMOUNTS.—Section
1833(h)(4)(B) (42 U.S.C. 1395l(h)(4)(B)) is amended—
(1) in clause (vi), by striking ‘‘and’’ at the end;
(2) in clause (vii)—
(A) by inserting ‘‘and before January 1, 1998,’’ after
‘‘1995,’’, and
(B) by striking the period at the end and inserting
‘‘, and’’; and
(3) by adding at the end the following new clause:
‘‘(viii) after December 31, 1997, is equal to 74 percent
of such median.’’.
(c) STUDY AND REPORT ON CLINICAL LABORATORY TESTS.—
(1) IN GENERAL.—The Secretary shall request the Institute
of Medicine of the National Academy of Sciences to conduct
a study of payments under part B of title XVIII of the Social
Security Act for clinical laboratory tests. The study shall include
a review of the adequacy of the current methodology and rec-
ommendations regarding alternative payment systems. The
study shall also analyze and discuss the relationship between
such payment systems and access to high quality laboratory
tests for medicare beneficiaries, including availability and
access to new testing methodologies.
(2) REPORT TO CONGRESS.—The Secretary shall, not later
than 2 years after the date of enactment of this section, report
to the Committees on Ways and Means and Commerce of
the House of Representatives and the Committee on Finance
of the Senate the results of the study described in paragraph
(1), including any recommendations for legislation.
SEC. 4554. IMPROVEMENTS IN ADMINISTRATION OF LABORATORY
TESTS BENEFIT.
(a) SELECTION OF REGIONAL CARRIERS.—
(1) IN
GENERAL.—The Secretary of Health and Human
Services (in this section referred to as the ‘‘Secretary’’) shall—
(A) divide the United States into no more than 5
regions, and
(B) designate a single carrier for each such region,
for the purpose of payment of claims under part B of title
XVIII of the Social Security Act with respect to clinical diag-
nostic laboratory tests furnished on or after such date (not
later than July 1, 1999) as the Secretary specifies.
(2) DESIGNATION.—In designating such carriers, the Sec-
retary shall consider, among other criteria—
(A) a carrier’s timeliness, quality, and experience in
claims processing, and
H. R. 2015—211
(B) a carrier’s capacity to conduct electronic data inter-
change with laboratories and data matches with other car-
riers.
(3) SINGLE
DATA
RESOURCE.—The Secretary shall select
one of the designated carriers to serve as a central statistical
resource for all claims information relating to such clinical
diagnostic laboratory tests handled by all the designated car-
riers under such part.
(4) ALLOCATION OF CLAIMS.—The allocation of claims for
clinical diagnostic laboratory tests to particular designated car-
riers shall be based on whether a carrier serves the geographic
area where the laboratory specimen was collected or other
method specified by the Secretary.
(5) SECRETARIAL EXCLUSION.—Paragraph (1) shall not apply
with respect to clinical diagnostic laboratory tests furnished
by physician office laboratories if the Secretary determines
that such offices would be unduly burdened by the application
of billing responsibilities with respect to more than one carrier.
(b) ADOPTION OF NATIONAL POLICIES FOR CLINICAL LABORATORY
TESTS BENEFIT.—
(1) IN GENERAL.—Not later than January 1, 1999, the Sec-
retary shall first adopt, consistent with paragraph (2), national
coverage and administrative policies for clinical diagnostic lab-
oratory tests under part B of title XVIII of the Social Security
Act, using a negotiated rulemaking process under subchapter
III of chapter 5 of title 5, United States Code.
(2) CONSIDERATIONS IN DESIGN OF NATIONAL POLICIES.—
The policies under paragraph (1) shall be designed to promote
program integrity and national uniformity and simplify
administrative requirements with respect to clinical diagnostic
laboratory tests payable under such part in connection with
the following:
(A) Beneficiary information required to be submitted
with each claim or order for laboratory tests.
(B) The medical conditions for which a laboratory test
is reasonable and necessary (within the meaning of section
1862(a)(1)(A) of the Social Security Act).
(C) The appropriate use of procedure codes in billing
for a laboratory test, including the unbundling of laboratory
services.
(D) The medical documentation that is required by
a medicare contractor at the time a claim is submitted
for a laboratory test in accordance with section 1833(e)
of the Social Security Act.
(E) Recordkeeping requirements in addition to any
information required to be submitted with a claim, includ-
ing physicians’ obligations regarding such requirements.
(F) Procedures for filing claims and for providing remit-
tances by electronic media.
(G) Limitation on frequency of coverage for the same
tests performed on the same individual.
(3) CHANGES IN LABORATORY POLICIES PENDING ADOPTION
OF NATIONAL POLICY.—During the period that begins on the
date of the enactment of this Act and ends on the date the
Secretary first implements national policies pursuant to regula-
tions promulgated under this subsection, a carrier under such
H. R. 2015—212
part may implement changes relating to requirements for the
submission of a claim for clinical diagnostic laboratory tests.
(4) USE OF INTERIM POLICIES.—After the date the Secretary
first implements such national policies, the Secretary shall
permit any carrier to develop and implement interim policies
of the type described in paragraph (1), in accordance with
guidelines established by the Secretary, in cases in which a
uniform national policy has not been established under this
subsection and there is a demonstrated need for a policy to
respond to aberrant utilization or provision of unnecessary
tests. Except as the Secretary specifically permits, no policy
shall be implemented under this paragraph for a period of
longer than 2 years.
(5) INTERIM NATIONAL POLICIES.—After the date the Sec-
retary first designates regional carriers under subsection (a),
the Secretary shall establish a process under which designated
carriers can collectively develop and implement interim national
policies of the type described in paragraph (1). No such policy
shall be implemented under this paragraph for a period of
longer than 2 years.
(6) BIENNIAL REVIEW PROCESS.—Not less often than once
every 2 years, the Secretary shall solicit and review comments
regarding changes in the national policies established under
this subsection. As part of such biennial review process, the
Secretary shall specifically review and consider whether to
incorporate or supersede interim policies developed under para-
graph (4) or (5). Based upon such review, the Secretary may
provide for appropriate changes in the national policies pre-
viously adopted under this subsection.
(7) REQUIREMENT AND NOTICE.—The Secretary shall ensure
that any policies adopted under paragraph (3), (4), or (5) shall
apply to all laboratory claims payable under part B of title
XVIII of the Social Security Act, and shall provide for advance
notice to interested parties and a 45-day period in which such
parties may submit comments on the proposed change.
(c) INCLUSION OF LABORATORY REPRESENTATIVE ON CARRIER
ADVISORY
COMMITTEES.—The Secretary shall direct that any
advisory committee established by a carrier to advise such carrier
with respect to coverage and administrative policies under part
B of title XVIII of the Social Security Act shall include an individual
to represent the independent clinical laboratories and such other
laboratories as the Secretary deems appropriate. The Secretary
shall consider recommendations from national and local organiza-
tions that represent independent clinical laboratories in such selec-
tion.
SEC. 4555. UPDATES FOR AMBULATORY SURGICAL SERVICES.
Section 1833(i)(2)(C) (42 U.S.C. 1395l(i)(2)(C)) is amended by
inserting at the end the following new sentence: ‘‘In each of the
fiscal years 1998 through 2002, the increase under this subpara-
graph shall be reduced (but not below zero) by 2.0 percentage
points.’’.
SEC. 4556. REIMBURSEMENT FOR DRUGS AND BIOLOGICALS.
(a) IN GENERAL.—Section 1842 (42 U.S.C. 1395u) is amended
by inserting after subsection (n) the following new subsection:
‘‘(o)(1) If a physician’s, supplier’s, or any other person’s bill
or request for payment for services includes a charge for a drug