[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1452 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1452

  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 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 
subsequently 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 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SEC. 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medicare Clinical 
Diagnostic Laboratory Fee Schedule Modernization Act of 2009''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
         TITLE I--UPDATING THE CLINICAL LABORATORY FEE SCHEDULE

Sec. 101. Findings and purpose.
Sec. 102. Process for the modernization of the fee schedule for 
                            clinical diagnostic laboratory tests.
Sec. 103. Establishment and duties of negotiated rulemaking committee.
Sec. 104. Result of committee action.
Sec. 105. Report by MedPAC.
Sec. 106. Definitions.
             TITLE II--UPDATING THE SPECIMEN COLLECTION FEE

Sec. 201. Adjustment in Medicare laboratory specimen collection fee.

         TITLE I--UPDATING THE CLINICAL LABORATORY FEE SCHEDULE

SEC. 101. FINDINGS AND PURPOSE.

    (a) Findings.--The Congress finds the following:
            (1) The fee schedule for clinical diagnostic laboratory 
        tests under part B of the Medicare program was developed in 
        1984 based on the local prevailing fees charged in 1983.
            (2) The cost of clinical diagnostic laboratory tests, 
        laboratory equipment, supplies, and medical professional staff 
        has increased exponentially in recent years.
            (3) Clinical laboratories are currently reimbursed at 
        levels below those provided in 1984 when adjusted for 
        inflation.
            (4) The fee schedule for clinical diagnostic laboratory 
        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 information that 
        influences 70 percent of all patient care decisions.
    (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 diagnostic 
        laboratory tests under part B of the Medicare program to 
        reflect the increased cost and enhanced 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 clinical 
        laboratory industry in the process of such fee schedule 
        modernization, including Medicare beneficiaries, health care 
        providers, and laboratories; and
            (4) to create mechanisms for periodic revisions, 
        inflationary updates, and inclusion of new methodologies to the 
        fee schedule for clinical diagnostic laboratory tests in order 
        to reflect market conditions.

SEC. 102. PROCESS FOR THE MODERNIZATION OF THE FEE SCHEDULE FOR 
              CLINICAL DIAGNOSTIC LABORATORY TESTS.

    (a) In General.--Pursuant to the provisions of this title and 
consistent with the elements described in subsection (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 diagnostic laboratory fee schedule 
        (as defined in section 106(3));
            (2) not later than 24 months after the date of the 
        enactment of this Act and pursuant to such negotiated 
        rulemaking process, submit to Congress a report under section 
        103(f)(2)(B) relating to such Medicare modernized clinical 
        diagnostic fee schedule; and
            (3) promulgate under section 104 final regulations 
        establishing such Medicare modernized clinical diagnostic fee 
        schedule if the Committee reaches consensus.
    (b) Elements.--
            (1) Elements for inclusion.--The negotiated rulemaking 
        committee established under section 103 shall consider the 
        following elements and include them in the proposed rule for a 
        Medicare modernized clinical diagnostic laboratory fee 
        schedule:
                    (A) Access, to the greatest extent possible, by all 
                individuals enrolled in part B of title XVIII of the 
                Social Security Act to quality laboratory 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 laboratory tests 
                        and technology into the fee schedule in a 
                        timely manner and to provide appropriate 
                        reimbursement for these tests.
                            (ii) The mechanism periodically and 
                        appropriately revises clinical laboratory 
                        reimbursement 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 revisions 
                        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 patients, 
                        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 aggregate payments under 
                such schedule for clinical 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 not been 
                enacted (taking into account annual adjustments under 
                paragraph (2) of such section, the annual addition of 
                new tests under paragraph (8) of such section, and any 
                other utilization increases that would have been 
                recognized 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 application 
                of the payment rates under the fee schedule based on 
                blended payment rates between such fee schedule and the 
                fee schedule in effect on the day before the date of 
                the enactment of this Act under section 1833(h) of the 
                Social Security Act for clinical laboratory services, 
                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 Medicare modernized clinical diagnostic 
        laboratory fee schedule:
                    (A) A fee schedule that provides for greater 
                administrative simplicity and efficiency by eliminating 
                or reducing the number of differential payment rates in 
                existence on the day before 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 requirements 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 establish a negotiated rulemaking 
committee (in this title referred to as the ``Committee'') in 
accordance with subchapter 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 106(3)). Not later than 60 days 
after the day on which such notice of intent is published, the 
Secretary shall appoint members to the Committee in accordance with 
subsection (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 individuals as follows:
                    (A) One individual from an organization primarily 
                representing independent clinical laboratories 
                operating on a national basis.
                    (B) One individual from an organization primarily 
                representing independent clinical laboratories 
                operating on a regional or local basis.
                    (C) One individual from an organization 
                representing hospitals that perform clinical diagnostic 
                laboratory tests.
                    (D) Two individuals from organizations representing 
                physicians with expertise in clinical diagnostic 
                laboratory tests.
                    (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 designed 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 diagnostic 
                laboratory tests.
                    (I) One individual with expertise in measuring 
                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 expertise in clinical 
                diagnostic laboratory tests.
                    (L) One individual who is a physician or clinician 
                who prescribes clinical diagnostic laboratory tests.
                    (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 background 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 Committee. The Chairman of the Medicare 
        Payment Advisory Commission shall appoint one nonvoting member 
        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) concerning 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.
    (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 original 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 Government employee may 
                be detailed to the Committee without reimbursement from 
                the Committee, and such detailee shall retain the 
                rights, status, and privileges of their regular 
                employment without interruption.
                    (B) Technical assistance.--If authorized by the 
                Secretary and approved by a majority 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 Advisory 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 appointed to the Committee under 
                        subsection (a), the Committee shall submit to 
                        the Secretary an initial interim report on the 
                        Committee's progress in negotiating a proposed 
                        rule to establish a Medicare modernized 
                        clinical diagnostic laboratory fee schedule, 
                        including the Committee's preliminary 
                        determinations regarding the establishment of 
                        such fee schedule and including preliminary 
                        determinations on the information described in 
                        subparagraph (B).
                            (ii) Subsequent interim report.--The 
                        Committee shall submit to the Secretary a 
                        subsequent interim report, which shall include 
                        updates to the determinations made in the 
                        report submitted under clause (i). Such 
                        subsequent interim report shall be submitted 
                        not later than 12 months after the date on 
                        which members are required to be appointed to 
                        the Committee under subsection (a).
                            (iii) Exception.--An interim report 
                        described in this subparagraph is not required 
                        to be submitted in the case that a final report 
                        under subparagraph (B) is submitted before the 
                        date on which such interim report is required 
                        to be submitted under this subparagraph.
                    (B) Final report.--Not later than 18 months after 
                the date on which members are required to be appointed 
                to the Committee under subsection (a), the Committee 
                shall submit to the Secretary a final report, including 
                the following:
                            (i) If the Committee reaches consensus by 
                        such 18-month date on a proposed rule to 
                        establish a Medicare modernized clinical 
                        diagnostic laboratory fee schedule--
                                    (I) the consensus proposed rule 
                                reached by the Committee; and
                                    (II) the Committee's determination 
                                regarding the extent to which, and 
                                manner in which, the proposed fee 
                                schedule will achieve the purpose 
                                described in section 101(b) and address 
                                the elements described in section 
                                102(b).
                            (ii) If the Committee fails to reach 
                        consensus by such 18-month date on a proposed 
                        rule to establish a Medicare modernized 
                        clinical diagnostic laboratory fee schedule--
                                    (I) any components of a fee 
                                schedule or other areas upon which 
                                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 Secretary 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 interim report on 
                the progress of the negotiated rulemaking process under 
                this section to establish a Medicare modernized 
                clinical diagnostic laboratory fee schedule. Each such 
                report shall include the corresponding interim report 
                submitted by the Committee under such paragraph.
                    (B) Final report.--Not later 24 months after the 
                date of the enactment of this Act, the Secretary 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 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 Secretary'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 laboratory fee schedule, the Secretary shall, to 
the maximum 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 comment 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 Committee 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 provided 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 enactment of this 
Act, the Medicare Payment Advisory Commission 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 modernized clinical diagnostic laboratory 
        fee schedule, with respect to the Secretary's proposed 
        regulation submitted under section 103(f)(2)(B)(ii) to 
        implement such proposed rule--
                    (A) whether the overall level of expenditures under 
                title XVIII of the Social Security Act for clinical 
                laboratory services under the revised fee schedule 
                under such proposed regulation is adequate to ensure 
                beneficiary access to high quality testing; and
                    (B) whether the periodic revision and inflationary 
                update mechanisms in the proposed regulation are 
                adequate to ensure beneficiary access 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 laboratory fee 
                schedule in accordance with the purpose described in 
                section 101(b) and the elements described in section 
                102(b), including with respect to such areas identified 
                in the report submitted under section 103(f)(1)(B)(ii) 
                as areas in which consensus was not reached by the 
                Committee;
                    (B) how to ensure the overall level of expenditures 
                under part B of title XVIII of such Act for clinical 
                laboratory services under a revised fee schedule is 
                adequate to ensure beneficiary access to high quality 
                testing; and
                    (C) how to ensure that periodic revision and 
                inflationary update mechanisms in a proposed revised 
                fee schedule for clinical laboratory services are 
                adequate to ensure beneficiary access to high quality 
                testing.

SEC. 106. DEFINITIONS.

    For purposes of this title:
            (1) Committee.--The term ``Committee'' means the negotiated 
        rulemaking committee established 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 diagnostic 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 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 SPECIMEN COLLECTION FEE.

    (a) In General.--Section 1833(h) of the Social Security 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
            (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 Consumer 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.
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