[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4395 Introduced in House (IH)]







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 
   beneficiaries 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 
addition to the Committee on Commerce, 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 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 Representatives 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 devices.
Sec. 5. Annual adjustments to medicare payment systems for changes in 
                            technology 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 
                            modifications.
Sec. 11. Establishment of procedures for medicare coding and payment 
                            determinations for new clinical diagnostic 
                            laboratory tests and other items on a fee 
                            schedule.

SEC. 2. ANNUAL REPORTS ON NATIONAL COVERAGE DETERMINATIONS.

    (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 
implement 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 complete each significant 
step in the process of making such determinations.
    (b) Publication of Reports on the Internet.--The Secretary of 
Health and Human Services shall publish each report submitted under 
subsection (a) on the medicare Internet site of the Department of 
Health and Human Services.

SEC. 3. IMPROVEMENTS TO THE MEDICARE ADVISORY COMMITTEE PROCESS.

    Section 1114 of the Social Security Act (42 U.S.C. 1314) is amended 
by adding at the end the following new subsection:
    ``(i)(1) Any advisory committee appointed under subsection (f) to 
advise the Secretary on matters relating to the interpretation, 
application, or implementation of section 1862(a)(1) shall assure the 
full participation of a nonvoting member in the deliberations of the 
advisory committee, and shall provide such nonvoting member access to 
all information and data made available to voting members of the 
advisory committee, other than information that--
            ``(A) is exempt from disclosure pursuant to subsection (a) 
        of section 552 of title 5, United States Code, by reason of 
        subsection (b)(4) of such section (relating to trade secrets); 
        and
            ``(B) the Secretary determines would present a conflict of 
        interest relating to such nonvoting member.
    ``(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 Secretary without the prior approval of the advisory 
committee 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 Social Security Act 
(42 U.S.C. 1395b-6(c)(2)(B)) is amended by inserting ``individuals with 
national recognition for their expertise in the development for market 
of new medical items, services, and devices,'' after ``other health 
professionals,''.
    (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 systems for changes in 
                    technology and medical practice

    ``Sec. 1889. (a) In General.--
            ``(1) ASC, mfs, and inpatient pps.--Notwithstanding 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 factors, 
        diagnosis-related group classifications, and assignments to 
        diagnosis-related groups) at least annually 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 systems.
            ``(2) OP pps.--For a provision requiring adjustments to the 
        elements of the outpatient prospective 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 section 1833(i)(2)(A), section 
1848(c)(2)(B), and section 1886(d)(4)(C) shall apply to the annual 
adjustments required 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 adjustments 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 representative 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 required 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 section and section 
        1833(t)(9)(A), the Secretary shall utilize data other than data 
        collected by the Secretary in the administration of the program 
        established under this title if--
                    ``(A) data collected by the Secretary in the 
                administration of such program are not available at the 
                time such adjustments are being determined; 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 
                                identify or refine data collected by 
                                the Secretary for use in making such an 
                                adjustment; and
                                    ``(II) are based on a 
                                representative sample of cases that is 
                                statistically 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 disclosure of protected 
                        health information.--Notwithstanding any other 
                        provision of law, individual authorization is 
                        not required for disclosure of protected health 
                        information to--
                                    ``(I) a government agency or 
                                private payer; or
                                    ``(II) a private entity for the 
                                purpose of disclosure to such an agency 
                                or payer,
                        for inclusion in data systems of the agency or 
                        payer for use in the formulation of coverage, 
                        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 determining 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 technologies;
                    ``(C) suppliers;
                    ``(D) groups representing physicians and other 
                health care professionals;
                    ``(E) groups representing providers;
                    ``(F) clinical trials; and
                    ``(G) such other sources as the Secretary 
                determines to be appropriate.
            ``(4) Clarification.--Nothing in this title shall be 
        construed as--
                    ``(A) requiring the Secretary to identify all 
                claims submitted under a payment system established 
                under section 1833(i)(2)(A), section 1833(t), section 
                1848, or section 1886(d) involving the use of a medical 
                technology before the Secretary may make the 
                adjustments under this section (or under section 
                1833(i)(2)(A), section 1833(t), section 1848, or 
                section 1886(d)) with respect to such technology; or
                    ``(B) authorizing the Secretary to defer action on 
                such an adjustment until all such claims are 
                identifiable.
            ``(5) Deadline for supplying external data.--The Secretary 
        shall establish a reasonable deadline for the submission of 
        data other than data collected by the Secretary to be used in 
        making the adjustments required by this section or section 
        1833(t)(9)(A). In no event may the deadline established 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 periods 
                beginning on or after October 1, 2001; and
                    ``(B) be described in the proposed and final rules 
                published by the Secretary with respect to changes to a 
                payment system established 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 section, the term 
        `provider payment update period' means--
                    ``(A) in the case of the payment system established 
                under section 1833(i)(2)(A) or section 1848, a calendar 
                year; and
                    ``(B) in the case of the payment system established 
                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 inserting ``Subject to section 1889, the''.
            (3) Inpatient hospital prospective payment 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 HOSPITAL OUTPATIENT SETTINGS.

    (a) Report by Secretary on Access to Devices.--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 beginning with 2001, the 
                Secretary shall submit to Congress a report on access 
                of individuals furnished covered OPD services (as 
                defined in paragraph (1)(B)) to medical devices in 
                conjunction with such services. Such report shall 
                include an analysis of the impact of paragraph (6)(A) 
                in making new devices available in hospital outpatient 
                departments, the extent to which barriers to such 
                availability have been overcome by reason of such 
                paragraph, the impact of including or excluding a 
                device under the payment system established by this 
                subsection on beneficiary access to such device, and a 
                description of efforts by the Secretary to increase the 
                use and availability of such devices in such 
                departments. 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.''.
    (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 devices 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 device 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 Security 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 paragraph (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 citations 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 provision of title XVIII 
of the Social Security Act (42 U.S.C. 1395 et seq.), 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 HCPCS level II code 
        modifications from the public throughout the year;
            (3) cause determinations on such recommendations 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 preceding the last month of a 
        calendar quarter into the payment systems established under 
        such title (including the medicare fee schedule data base) not 
        later than the first day of the following calendar quarter.
    (b) Elimination of Requirement for Marketing Experience.--
Notwithstanding any other provision of title XVIII of the Social 
Security Act, the Secretary 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 approval of a 
recommendation for an HCPCS level II modification 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 Administration 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 report a detailed explanation of the 
reasons for such determination.
    (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 system 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 Administration Common Procedure Coding System 
(HCPCS).

SEC. 10. PROCESS FOR MAKING AND IMPLEMENTING ICD-9-CM CODING 
              MODIFICATIONS.

    (a) In General.--Notwithstanding any other provision of title XVIII 
of the Social Security Act (42 U.S.C. 1395 et seq.), with respect to 
payments for inpatient hospital 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 recommendations 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 preceding the last month of a 
        calendar quarter into the payment systems established under 
        such title (including the medicare fee schedule data base) not 
        later than the first day of the following calendar quarter.
    (b) Elimination of Requirement for Marketing Experience.--
Notwithstanding any other provision of title XVIII of the Social 
Security Act, the Secretary 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 modification 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 Classification of Diseases, 9th Revision, Clinical 
Modification, applied under such section 1886.
    (d) MedPAC Report.--Not later than January 1, 2001, the Medicare 
Payment Advisory Commission established 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 Financing 
        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 system established under such 
        section are appropriate and timely for new technologies and 
        provide appropriate and timely recognition of changes in the 
        technology; 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 recognition of changes in technology under such system.

SEC. 11. ESTABLISHMENT OF PROCEDURES FOR MEDICARE CODING AND PAYMENT 
              DETERMINATIONS FOR NEW CLINICAL DIAGNOSTIC LABORATORY 
              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 clinical 
diagnostic laboratory tests and durable medical equipment. Such 
procedures (which may vary for the 2 categories of items and services 
referred to in the preceding sentence) shall provide for the following:
            (1) Such procedures shall be clearly understandable and 
        follow a predictable format. Any hearings or meetings with 
        respect to the determinations shall be open to the public and 
        provide for public participation.
            (2) Under the procedures, the Secretary shall identify the 
        rules and assumptions to be applied in considering the coding 
        or payment determination, and shall provide the sources and 
        types of data to be used in making such determination.
            (3) Under the procedures, the Secretary shall provide a 
        clear statement of the basis for the determination.
            (4) Under the procedures, the Secretary shall make 
        available to the public the data (other than proprietary data) 
        considered in making the determination.
            (5) Under the procedures, the Secretary shall consider and 
        implement coding modifications under procedures similar to 
        those for HCPCS level II and ICD-9-CM procedure and related 
        codes.
            (6) Under the procedures, the Secretary shall provide for 
        consistent instructions to carriers to carry out their 
        functions in setting prices for new technologies that--
                    (A) are designed to establish fair and appropriate 
                payment levels reflecting market conditions for such 
                items and services; and
                    (B) in the case of clinical diagnostic laboratory 
                tests for which payment is made on a fee schedule basis 
                under title XVIII of the Social Security Act, comply 
                with the requirements of section 1833(h)(8) of such Act 
                (42 U.S.C. 1395l(h)(8)).
            (7) Under the procedures, the Secretary shall provide a 
        mechanism under which an interested party may request a timely 
        review of the adequacy of the existing fee for a particular 
        item or service, and upon receipt of such a request that such 
        timely review is carried out.
            (8) Under the procedures, the Secretary shall provide for a 
        mechanism under which an interested party may request 
        administrative review of an adverse coding or payment policy 
        determination, and shall provide for such review and, if 
        necessary, revision of the determination.
    (b) Establishing Payment Rates for New Lab Tests.--Section 1833(h) 
of the Social Security Act (42 U.S.C. 1395l(h)) is amended by adding at 
the end the following:
    ``(8)(A) Notwithstanding paragraphs (1), (2), and (4), in the case 
of a clinical diagnostic laboratory test with respect to which a code 
is first assigned under the Health Care Financing Administration Common 
Procedure Coding System (hereinafter referred to as `HCPCS') on or 
after January 1, 2001, the Secretary shall provide for the 
establishment of payment rates in accordance with subparagraph (B) or 
(C).
    ``(B) In the case of a clinical diagnostic laboratory test 
described in subparagraph (A) with respect to which the Secretary 
proposes to base payment on the fee schedule amounts determined under 
paragraph (1) and the national limitation amount determined under 
paragraph (4) for one or more similar clinical diagnostic laboratory 
tests, the Secretary shall--
            ``(i) cause to have published in the Federal Register not 
        later than July 1 of each calendar year (beginning with 
        calendar year 2001) the Secretary's proposal with respect to 
        the appropriate fee schedule amounts and national limitation 
        amount for such test for the following calendar year; and
            ``(ii) provide an opportunity for the public to comment on 
        such proposal.
    ``(C)(i) In the case of a clinical diagnostic laboratory test 
described in subparagraph (A) with respect to which payment is not 
determined in accordance with subparagraph (B)--
            ``(I) payment under this subsection shall be made on the 
        basis of the prevailing charge level for the test for a 
        locality or area (determined without regard to the percentage 
        limitation or the base year referred to in paragraph (2)(A)); 
        and
            ``(II) the limitation amounts referred to in subsection 
        (a)(1)(D)(i), subsection (a)(2)(D)(i), and paragraph (4)(B) 
        shall not apply,
until the beginning of the third full calendar year that begins on or 
after the date on which an HCPCS code is first assigned with respect to 
such test, or, if later, the beginning of the first calendar year that 
begins on or after the date on which the Secretary determines that 
there are sufficient claims data to establish a limitation amount under 
paragraph (4)(B).
    ``(ii) Notwithstanding paragraph (2)(A), the Secretary shall--
            ``(I) set the fee schedules under paragraph (1) for a 
        clinical diagnostic laboratory test described in clause (i) for 
        any calendar year beginning after the base year at 100 percent 
        of the prevailing charge level for such test for the applicable 
        region, State, or area for the base year, adjusted annually (to 
        become effective on January 1 of each year) by the percentage 
        increase or decrease in the Consumer Price Index for All Urban 
        Consumers (United States city average), and subject to such 
        other adjustments as the Secretary determines are justified by 
        technological changes; and
            ``(II) determine the limitation amount referred to in 
        subsection (a)(1)(D)(i), subsection (a)(2)(D)(i), and paragraph 
        (4)(B) for such test based on the fee schedules set under 
        subclause (I).
    ``(iii) For purposes of clause (ii), the term `base year' means, 
with respect to a clinical diagnostic laboratory test, the last full 
calendar year during which payment for such test was determined in 
accordance with clause (i).''.
    (c) Prohibition.--The Secretary may not assign a code for a new 
clinical diagnostic laboratory test that differs from the code 
recommended by the American Medical Association Common Procedure 
Terminology Editorial Panel and results in lower payment than would be 
made if the Secretary accepted such recommendation solely on the basis 
that the test is a test that may be performed by a laboratory with a 
certificate of waiver under section 353(d)(2) of the Public Health 
Service Act (42 U.S.C. 263a(d)(2)).
                                 <all>