I 
111TH CONGRESS 
1ST SESSION H. R. 1452 
To require the Secretary of Health and Human Services to enter into nego-
tiated rulemaking to modernize the Medicare part B fee schedule for 
clinical diagnostic laboratory tests and to amend title XVIII of the 
Social Security Act to adjust the fee for collecting specimens for clinical 
diagnostic laboratory tests under the Medicare Program. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 11, 2009 
Mr. STUPAK (for himself and Mr. BURGESS) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To require the Secretary of Health and Human Services 
to enter into negotiated rulemaking to modernize the 
Medicare part B fee schedule for clinical diagnostic lab-
oratory tests and to amend title XVIII of the Social 
Security Act to adjust the fee for collecting specimens 
for clinical diagnostic laboratory tests under the Medi-
care Program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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professional staff has increased exponentially in re-
cent years. 
(3) Clinical laboratories are currently reim-
bursed at levels below those provided in 1984 when 
adjusted for inflation. 
(4) The fee schedule for clinical diagnostic lab-
oratory tests is the last Medicare fee schedule that 
has not been made reliant on prospective payment or 
relative value as the primary payment methodology. 
(5) Clinical laboratories provide vital informa-
tion that influences 70 percent of all patient care de-
cisions. 
(b) PURPOSE.—The purpose of this Act is— 
(1) to ensure Medicare beneficiary access to the 
best laboratory services and most advanced testing 
available; 
(2) to modernize the fee schedule for clinical di-
agnostic laboratory tests under part B of the Medi-
care program to reflect the increased cost and en-
hanced technology involved in laboratory testing and 
to reflect accurately and equitably the value of such 
testing to the health care system; 
(3) to involve relevant stakeholders in the clin-
ical laboratory industry in the process of such fee 
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schedule modernization, including Medicare bene-
ficiaries, health care providers, and laboratories; and 
(4) to create mechanisms for periodic revisions, 
inflationary updates, and inclusion of new meth-
odologies to the fee schedule for clinical diagnostic 
laboratory tests in order to reflect market condi-
tions. 
SEC. 102. PROCESS FOR THE MODERNIZATION OF THE FEE 
SCHEDULE FOR CLINICAL DIAGNOSTIC LAB-
ORATORY TESTS. 
(a) IN GENERAL.—Pursuant to the provisions of this 
title and consistent with the elements described in sub-
section (b), the Secretary of Health and Human Services 
shall— 
(1) establish under section 103(a) a negotiated 
rulemaking committee to negotiate and develop a 
proposed rule for a Medicare modernized clinical di-
agnostic laboratory fee schedule (as defined in sec-
tion 106(3)); 
(2) not later than 24 months after the date of 
the enactment of this Act and pursuant to such ne-
gotiated rulemaking process, submit to Congress a 
report under section 103(f)(2)(B) relating to such 
Medicare modernized clinical diagnostic fee schedule; 
and 
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(3) promulgate under section 104 final regula-
tions establishing such Medicare modernized clinical 
diagnostic fee schedule if the Committee reaches 
consensus. 
(b) ELEMENTS.— 
(1) ELEMENTS
FOR
INCLUSION.—The nego-
tiated rulemaking committee established under sec-
tion 103 shall consider the following elements and 
include them in the proposed rule for a Medicare 
modernized clinical diagnostic laboratory fee sched-
ule: 
(A) Access, to the greatest extent possible, 
by all individuals enrolled in part B of title 
XVIII of the Social Security Act to quality lab-
oratory services in all settings. 
(B) Establishment of a single, rational, 
and national fee schedule for clinical diagnostic 
laboratory tests. 
(C) A mechanism to periodically revise the 
fee schedule for years subsequent to the first 
year in which the fee schedule is implemented 
that includes the following components: 
(i) The mechanism is sufficiently 
adaptable to incorporate new clinical lab-
oratory tests and technology into the fee 
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schedule in a timely manner and to provide 
appropriate reimbursement for these tests. 
(ii) The mechanism periodically and 
appropriately revises clinical laboratory re-
imbursement to reflect the evolution of 
costs, value, and utilization of such tests. 
(iii) The mechanism is not based on 
an arbitrary cap. 
(iv) The mechanism provides for revi-
sions to the fee schedule at least once 
every five years, but not more frequently 
than annually. 
(v) The mechanism provides for input 
from relevant stakeholders, including pa-
tients, health care providers, and clinical 
laboratories. 
(D) For the first year for which the fee 
schedule is implemented, the fee schedule shall 
be designed to result in the same amount of ag-
gregate payments under such schedule for clin-
ical laboratory services furnished during such 
year for which payment is made under part B 
of title XVIII of the Social Security Act as 
would have been made under section 1833(h) of 
such Act for such services if this section had 
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not been enacted (taking into account annual 
adjustments under paragraph (2) of such sec-
tion, the annual addition of new tests under 
paragraph (8) of such section, and any other 
utilization increases that would have been rec-
ognized under such section). 
(E) A mechanism to provide for automatic 
annual inflationary updates to the fee schedule 
for each year after the first year for which the 
fee schedule is implemented. 
(F) A transition period to phase in the ap-
plication of the payment rates under the fee 
schedule based on blended payment rates be-
tween such fee schedule and the fee schedule in 
effect on the day before the date of the enact-
ment of this Act under section 1833(h) of the 
Social Security Act for clinical laboratory serv-
ices, which is to be provided in an efficient and 
fair manner. 
(G) A fee schedule that does not utilize 
beneficiary cost sharing. 
(2) ELEMENTS
FOR
CONSIDERATION.—Such 
negotiated rulemaking committee shall consider 
whether to include the following elements in the 
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Medicare modernized clinical diagnostic laboratory 
fee schedule: 
(A) A fee schedule that provides for great-
er administrative simplicity and efficiency by 
eliminating or reducing the number of differen-
tial payment rates in existence on the day be-
fore the date of the enactment of this Act under 
section 1833(h) of the Social Security Act for 
clinical diagnostic laboratory tests. 
(B) A fee schedule that addresses the 
unique reimbursement problems laboratories 
face as indirect providers, including require-
ments that laboratories must rely on diagnosis 
codes provided by ordering providers. 
SEC. 103. ESTABLISHMENT AND DUTIES OF NEGOTIATED 
RULEMAKING COMMITTEE. 
(a) ESTABLISHMENT.—Not later than 30 days after 
the date of the enactment of this Act, the Secretary shall 
publish a notice in the Federal Register of intent to estab-
lish a negotiated rulemaking committee (in this title re-
ferred to as the ‘‘Committee’’) in accordance with sub-
chapter III of chapter 5 of title 5, United States Code 
(5 U.S.C. 561 et seq.) and this section to negotiate and 
develop a proposed rule for a Medicare modernized clinical 
diagnostic laboratory fee schedule (as defined in section 
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106(3)). Not later than 60 days after the day on which 
such notice of intent is published, the Secretary shall ap-
point members to the Committee in accordance with sub-
section (b). 
(b) COMPOSITION OF COMMITTEE.— 
(1) IN
GENERAL.—Notwithstanding section 
565(b) of title 5, United States Code, the Committee 
shall be composed of 19 voting members appointed 
pursuant to paragraph (2) and 2 nonvoting members 
appointed pursuant to paragraph (3). 
(2) VOTING
MEMBERS.—The Secretary shall 
appoint as voting members of the Committee individ-
uals as follows: 
(A) One individual from an organization 
primarily representing independent clinical lab-
oratories operating on a national basis. 
(B) One individual from an organization 
primarily representing independent clinical lab-
oratories operating on a regional or local basis. 
(C) One individual from an organization 
representing hospitals that perform clinical di-
agnostic laboratory tests. 
(D) Two individuals from organizations 
representing physicians with expertise in clinical 
diagnostic laboratory tests. 
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(E) Three individuals from organizations 
representing non-physicians with expertise in 
clinical diagnostic laboratory tests. 
(F) One individual from an organization 
representing manufacturers of equipment de-
signed for clinical diagnostic laboratory tests. 
(G) One individual from an organization 
representing individuals enrolled under part B 
of title XVIII of the Social Security Act. 
(H) One individual from an organization 
representing private payers for clinical diag-
nostic laboratory tests. 
(I) One individual with expertise in meas-
uring resource utilization by clinical diagnostic 
laboratories in performing tests. 
(J) One individual with a background in 
health economics and the ability to quantify the 
value of clinical diagnostic laboratory tests. 
(K) Two individuals from organizations 
representing generalist non-physicians with ex-
pertise in clinical diagnostic laboratory tests. 
(L) One individual who is a physician or 
clinician who prescribes clinical diagnostic lab-
oratory tests. 
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(M) One individual who is a physician or 
clinician who performs point-of-care tests in the 
physician’s or clinician’s office. 
(N) One individual from an organization 
representing individuals with scientific back-
ground and experience in clinical laboratory 
health care services. 
(O) One individual from an organization 
representing managers or supervisors of clinical 
laboratories. 
(3) NONVOTING
MEMBERS.—The Secretary 
shall appoint one nonvoting member to the Com-
mittee. The Chairman of the Medicare Payment Ad-
visory Commission shall appoint one nonvoting mem-
ber to the Committee. 
(c) DUTIES OF COMMITTEE.—The Committee shall 
negotiate and attempt to reach a consensus (as defined 
in section 562(2) of title 5, United States Code) con-
cerning a proposed rule with respect to establishing a 
Medicare modernized clinical diagnostic laboratory fee 
schedule and any other matter the committee determines 
is relevant to the proposed rule. In its negotiations, the 
Committee shall take into account the purpose described 
in section 101(b), the elements listed in section 102(b), 
and the input of relevant stakeholders. 
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(d) TERM; VACANCIES.— 
(1) TERM.—Each member of the Committee 
shall be appointed for the life of the Committee. 
(2) VACANCIES.—A vacancy on the Committee 
shall be filled in the same manner in which the origi-
nal appointment was made. 
(e) ADMINISTRATIVE PROVISIONS.— 
(1) QUORUM.—A quorum shall be required to 
conduct the business of the Committee. Twelve 
members of the Committee shall constitute a 
quorum. 
(2) MEETINGS.—The Committee shall meet at 
the call of the Facilitator (as chosen under section 
566(c) of title 5, United States Code), the Secretary, 
or a quorum of the members of the Committee. 
(3) COMPENSATION.—The members of the 
Committee may be compensated in accordance with 
section 568(c) of title 5, United States Code. 
(4) STAFFING.— 
(A) DETAILING.—Any Federal Govern-
ment employee may be detailed to the Com-
mittee without reimbursement from the Com-
mittee, and such detailee shall retain the rights, 
status, and privileges of their regular employ-
ment without interruption. 
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(B) TECHNICAL ASSISTANCE.—If author-
ized by the Secretary and approved by a major-
ity of the Committee, the Committee may retain 
the services of experts and consultants under 
section 3109(b) of title 5, United States Code, 
but at rates not to exceed the daily equivalent 
of the annual rate of basic pay for level IV of 
the Executive Schedule under section 5315 of 
such title. 
(5) APPLICABILITY OF FACA.—The Federal Ad-
visory Committee Act (5 U.S.C. App.) shall apply to 
the Committee in accordance with section 565(a)(1) 
of title 5, United States Code. 
(f) REPORTS.— 
(1) COMMITTEE REPORTS.— 
(A) INTERIM REPORTS.— 
(i) INITIAL
INTERIM
REPORT.—Not 
later than 6 months after the date on 
which members are required to be ap-
pointed to the Committee under subsection 
(a), the Committee shall submit to the Sec-
retary an initial interim report on the 
Committee’s progress in negotiating a pro-
posed rule to establish a Medicare modern-
ized clinical diagnostic laboratory fee 
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consensus was achieved in accordance 
with the purpose described in section 
101(b) and the elements described in 
section 102(b); and 
(II) any components of a fee 
schedule or other areas upon which 
disagreement 
prevented 
consensus 
from being achieved in accordance 
with the purpose described in section 
101(b) and the elements described in 
section 102(b). 
(2) SECRETARIAL REPORTS.— 
(A) INTERIM REPORTS.—Not later than 30 
days after the date of the submission of each 
interim report under paragraph (1)(A), the Sec-
retary shall submit to the Committee on Energy 
and Commerce and the Committee on Ways 
and Means of the House of Representatives and 
the Committee on Finance of the Senate an in-
terim report on the progress of the negotiated 
rulemaking process under this section to estab-
lish a Medicare modernized clinical diagnostic 
laboratory fee schedule. Each such report shall 
include the corresponding interim report sub-
mitted by the Committee under such paragraph. 
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(B) FINAL REPORT.—Not later 24 months 
after the date of the enactment of this Act, the 
Secretary shall submit to the Committee on En-
ergy and Commerce and the Committee on 
Ways and Means of the House of Representa-
tives and the Committee on Finance of the Sen-
ate a final report, including— 
(i) the final report of the Committee 
submitted under paragraph (1)(B); and 
(ii) in the case that the Committee 
reaches a consensus on a proposed rule to 
establish a Medicare modernized clinical 
diagnostic laboratory fee schedule, the Sec-
retary’s proposed regulation to implement 
the proposed rule. 
(3) PUBLIC AVAILABILITY OF REPORTS.—The 
Secretary shall make each report submitted under 
this subsection available to the public on the official 
Internet website of the Department of Health and 
Human Services. 
SEC. 104. RESULT OF COMMITTEE ACTION. 
(a) COMMITTEE CONSENSUS.—If the Committee 
reaches a consensus under section 103 on a proposed rule 
to establish a Medicare modernized clinical diagnostic lab-
oratory fee schedule, the Secretary shall, to the maximum 
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extent possible consistent with the legal obligations of the 
agency, use the consensus of the Committee as the basis 
for the rule proposed by the agency for notice and com-
ment and, not later than 36 months after the date of the 
enactment of this Act, issue final regulations to apply to 
items and services furnished on or after the first January 
1st following the date of the promulgation of such final 
regulations. 
(b) LACK OF COMMITTEE CONSENSUS.—If the Com-
mittee fails to reach a consensus under section 103 on a 
proposed rule to establish a Medicare modernized clinical 
diagnostic laboratory fee schedule, authority remains with 
the Congress to establish such fee schedule, taking into 
account the purpose described in section 101(b) and the 
elements described in section 102(b) and the report pro-
vided by the Medicare Payment Advisory Commission 
under section 105(2). 
SEC. 105. REPORT BY MEDPAC. 
Not later than 39 months after the date of the enact-
ment of this Act, the Medicare Payment Advisory Com-
mission shall submit to Congress a report, including the 
following recommendations: 
(1) COMMITTEE CONSENSUS.—In the case that 
the Committee reaches consensus under section 103 
on a proposed rule to establish a Medicare modern-
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ized clinical diagnostic laboratory fee schedule, with 
respect to the Secretary’s proposed regulation sub-
mitted under section 103(f)(2)(B)(ii) to implement 
such proposed rule— 
(A) whether the overall level of expendi-
tures under title XVIII of the Social Security 
Act for clinical laboratory services under the re-
vised fee schedule under such proposed regula-
tion is adequate to ensure beneficiary access to 
high quality testing; and 
(B) whether the periodic revision and infla-
tionary update mechanisms in the proposed reg-
ulation are adequate to ensure beneficiary ac-
cess to high quality testing. 
(2) LACK OF COMMITTEE CONSENSUS.—In the 
case that the Committee does not reach consensus 
under section 103 on a proposed rule to establish a 
Medicare modernized clinical diagnostic laboratory 
fee schedule— 
(A) how to modernize such clinical labora-
tory fee schedule in accordance with the pur-
pose described in section 101(b) and the ele-
ments described in section 102(b), including 
with respect to such areas identified in the re-
port submitted under section 103(f)(1)(B)(ii) as 
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areas in which consensus was not reached by 
the Committee; 
(B) how to ensure the overall level of ex-
penditures under part B of title XVIII of such 
Act for clinical laboratory services under a re-
vised fee schedule is adequate to ensure bene-
ficiary access to high quality testing; and 
(C) how to ensure that periodic revision 
and inflationary update mechanisms in a pro-
posed revised fee schedule for clinical laboratory 
services are adequate to ensure beneficiary ac-
cess to high quality testing. 
SEC. 106. DEFINITIONS. 
For purposes of this title: 
(1) 
COMMITTEE.—The 
term 
‘‘Committee’’ 
means the negotiated rulemaking committee estab-
lished under section 103(a). 
(2) CONSENSUS.—The term ‘‘consensus’’ has 
the meaning given such term under section 562(2) 
of title 5, United States Code. 
(3) MEDICARE
MODERNIZED
CLINICAL
DIAG-
NOSTIC
LABORATORY
FEE
SCHEDULE.—The term 
‘‘Medicare modernized clinical diagnostic laboratory 
fee schedule’’ means a modernized fee schedule for 
payment under part B of title XVIII of the Social 
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Security Act for clinical diagnostic laboratory tests, 
the payment for which, as of the day before the date 
of the enactment of this Act, is provided for under 
section 1833(h) of the Social Security Act (42 
U.S.C. 1395l(h)). 
(4) NEGOTIATED
RULEMAKING.—The term 
‘‘negotiated rulemaking’’ has the meaning given 
such term under section 562(6) of title 5, United 
States Code. 
(5) NEGOTIATED RULEMAKING COMMITTEE.— 
The term ‘‘negotiated rulemaking committee’’ has 
the meaning given such term under section 562(7) 
of title 5, United States Code. 
(6) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
TITLE II—UPDATING THE 
SPECIMEN COLLECTION FEE 
SEC. 201. ADJUSTMENT IN MEDICARE LABORATORY SPECI-
MEN COLLECTION FEE. 
(a) IN GENERAL.—Section 1833(h) of the Social Se-
curity Act (42 U.S.C. 1395l(h)) is amended— 
(1) in paragraph (3)(A), by inserting ‘‘in the 
amount specified in paragraph (8)’’ after ‘‘a nominal 
fee’’; and 
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(2) by adding at the end the following new 
paragraph: 
‘‘(8) The amount specified in this paragraph, 
for the nominal fee under paragraph (3)(A) for tests 
performed in— 
‘‘(A) 2010, is $6.04; or 
‘‘(B) a subsequent year, is the amount 
specified in this paragraph for tests performed 
in the preceding year adjusted by the annual 
percentage increase or decrease in the Con-
sumer Price Index for All Urban Consumers 
(United States city average).’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to fees for tests performed on 
or after January 1, 2010. 
Æ 
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