[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2030 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2030

To amend title XVIII of the Social Security Act to improve the process 
  by which the Secretary of Health and Human Services makes coverage 
  determinations for items and services furnished under the Medicare 
                    Program, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 7, 1999

 Mr. Ramstad 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 process 
  by which the Secretary of Health and Human Services makes coverage 
  determinations for items and services furnished 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 Patient 
Access to Technology Act of 1999''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Establishment of medicare advisory committees.
Sec. 4. Annual adjustments to medicare payment systems for changes in 
                            technology and medical practice.
Sec. 5. Process for making and implementing certain coding 
                            modifications.
Sec. 6. Retention of HCPCS level III codes.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) In order to assure genuine access of medicare 
        beneficiaries to medical technologies, the Secretary of Health 
        and Human Services has an obligation to integrate and 
        coordinate its medical technology coverage policy determination 
        process with agency policies and practices that govern 
        assignment of procedure codes, establishment and adjustment of 
        payment levels and groupings, and issuance of timely 
        instructions to contractors.
            (2) The effectiveness of the medicare program in meeting 
        beneficiary needs is compromised if access to state-of-the-art 
        medical care is denied as a result of ineffective agency 
        performance in the coverage, coding, or payment processes, or 
        in the ineffective administrative execution of medical 
        technology decisions.
            (3) The Secretary of Health and Human Services owes 
        medicare beneficiaries the assurance that the various medicare 
        payment systems (in both the fee-for-service and managed care 
        areas) are operated in a way that reflects developments in, and 
        improvements upon, medical technology by properly setting and 
        adjusting payment levels and payment groups.
            (4) Clear, predictable, and well-functioning coverage, 
        coding, and payment systems are particularly critical to this 
        country's small medical technology companies, which are the 
        originators of most medical product innovations.
            (5) Unless medicare's coverage, coding, and payment systems 
        review products promptly, apply standards appropriate for 
        medical technology, and provide reasonable reimbursement 
        levels, these companies will experience difficulties in 
        bringing the benefits of medical innovation to medicare 
        beneficiaries.

SEC. 3. ESTABLISHMENT OF MEDICARE ADVISORY COMMITTEES.

    (a) In General.--Title XVIII of the Social Security Act (42 U.S.C. 
1395 et seq.) is amended by adding at the end the following new 
section:

                     ``medicare advisory committees

    ``Sec. 1897. (a) Establishment of Medicare Advisory Committees.--
For the purpose of securing advice and recommendations on issues 
related to coverage, payment, and coding decisions, the Secretary shall 
establish, under section 9(a)(1) of the Federal Advisory Committee Act, 
the advisory committees described in this section.
    ``(b) Medicare Payment and Coding Advisory Committee.--
            ``(1) Establishment.--For the purpose of securing advice 
        and recommendations on payment and coding issues under this 
        title, not later than January 1, 2000, the Secretary shall 
        establish the Medicare Payment and Coding Advisory Committee 
        (hereinafter in this subsection referred to as the 
        `Committee'). The Secretary shall consult with the Committee, 
        and may consult directly with any panel of the Committee 
        established pursuant to subsection (d)(1).
            ``(2) Duties.--The Committee, and its panels, shall provide 
        advice and recommendations to the Secretary on policies 
        regarding payment and coding issues under this title, including 
        identification of--
                    ``(A) policies and mechanisms to help ensure that 
                payment and coding decisions are--
                            ``(i) made in a way that encourages access 
                        to high-quality medical care under this title;
                            ``(ii) made through processes that allow 
                        for significant public participation; and
                            ``(iii) made expeditiously, in accordance 
                        with specified time frames for each significant 
                        step in the process of making such decisions;
                    ``(B) an equitable mechanism for determining fee 
                schedule payment amounts for items and services (other 
                than physicians' services); and
                    ``(C) processes for reconsideration and appeal of 
                determinations of fee schedule payment amounts.
            ``(3) Report.--
                    ``(A) Annual report to the secretary.--Not later 
                than December 1 of each of fiscal years 2000 through 
                2003, the Committee shall submit to the Secretary a 
                report on the progress of the Committee progress during 
                the preceding fiscal year, in carrying out the duties 
                under paragraph (2).
                    ``(B) Publication of report.--Not later than 60 
                days after receipt of the report under subparagraph 
                (A), the Secretary shall publish the report, together 
                with any supplemental views of the Secretary, on the 
                Internet site of the Department of Health and Human 
                Services.
            ``(4) Termination.--The Committee shall terminate on 
        September 30, 2003.
    ``(c) Advisory Committee on Medicare Access to Technology.--
            ``(1) Establishment.--Not later than July 1, 2003, the 
        Secretary shall establish the Medicare Access to Technology 
        Advisory Committee (hereinafter in this subsection referred to 
        as the `Committee'). The Secretary shall consult with the 
        Committee, and may consult directly with any panel of the 
        Committee established pursuant to subsection (d)(1).
            ``(2) Duties.--The Committee, and its panels, shall provide 
        advice and recommendations to the Secretary with respect to--
                    ``(A) the issues referred to the Medicare Coverage 
                Advisory Committee (established by the Secretary on 
                November 24, 1998, notice of which was printed in the 
                Federal Register on December 14, 1998, (63 FR 68780));
                    ``(B) the issues referred to the Medicare Payment 
                and Coding Advisory Committee under subsection (b); and
                    ``(C) integrating policies on coverage, payment, 
                and coding under this title into a process that helps 
                to assure timely access to high-quality medical care.
            ``(3) Report.--
                    ``(A) Annual report to the secretary.--Not later 
                than December 1 of every year beginning with 2004, the 
                Committee shall submit to the Secretary a report on the 
                progress of the Committee during the preceding fiscal 
                year, in accomplishing the duty described in paragraph 
                (2)(C).
                    ``(B) Publication of report.--Not later than 60 
                days after receipt of the report under subparagraph 
                (A), the Secretary shall publish the report, together 
                with any supplemental views of the Secretary, on the 
                Internet site of the Department of Health and Human 
                Services.
            ``(4) Duration.--Section 14(a)(2)(B) of the Federal 
        Advisory Committee Act (5 U.S.C. App.; relating to the 
        termination of advisory committees) shall not apply to the 
        Committee.
    ``(d) Advisory Committee Procedures.--In administering each of the 
advisory committees under this section, the Secretary shall--
            ``(1) organize each advisory committee into panels of 
        experts according to types of items or services;
            ``(2) solicit nominations as needed from the public by 
        publishing a notice in the Federal Register and on the Internet 
        site of the Department of Health and Human Services;
            ``(3) ensure participation on each advisory committee of 
        persons who--
                    ``(A) are experts in a variety of medical 
                specialties and fields of science, in specific areas of 
                medical technology (such as clinical and diagnostic 
                tests and durable medical equipment), in medical 
                research generally (such as the study of treatment 
                outcomes), and in other areas relevant to the duties 
                assigned to the advisory committee (taking into 
                account, as appropriate, any affiliations individuals 
                may have with organizations possessing information, 
                expertise, and other resources that would contribute 
                significantly to the work of the advisory committee and 
                its panels);
                    ``(B) are qualified by training and experience to 
                evaluate the matters referred to the advisory committee 
                (including, on each panel, a representative of consumer 
                interests and a representative of the interests of 
                manufacturers of medical technology); and
                    ``(C) have adequately diversified backgrounds so 
                that the advisory committee will provide balanced 
                advice and recommendations;
            ``(4) exclude from membership on each advisory committee 
        individuals who are in the full time employ of the United 
        States and engaged in the administration of the program 
        established under this title;
            ``(5) limit the number of members of each advisory 
        committee who are otherwise in the full-time employ of the 
        United States to not more than 10 percent of the total 
        membership of the advisory committee;
            ``(6) impose appropriate term limits for members of each 
        advisory committee;
            ``(7) designate one of the members of each panel to serve 
        as the chair thereof and appoint an executive subcommittee 
        comprised of the chairs of each panel to advise the Secretary 
        regarding--
                    ``(A) establishing priorities; and
                    ``(B) referring issues to appropriate panels;
            ``(8) permit each panel to independently advise the 
        Secretary with regard to matters referred to the panel, without 
the need to obtain the concurrence of the full advisory committee;
            ``(9) provide for appropriate consultation with outside 
        experts by each advisory committee and its panels;
            ``(10) provide for--
                    ``(A) full public participation, to the extent 
                required or permitted under law, in any meeting of each 
                advisory committee or its panels;
                    ``(B) at least 60 days' advance notice on the 
                Internet site of the Department of Health and Human 
                Services of any such meeting, including a statement of 
                the issues to be considered by the advisory committee 
                or panel, a description of the specific information 
                that is relevant to such issues, and the text of any 
                proposals the Secretary will ask the advisory committee 
                or panel to consider;
                    ``(C) consideration by each advisory committee or 
                panel of relevant information or testimony that is 
                submitted by the public; and
                    ``(D) public access in a central repository to the 
                information described in subparagraph (C) at least 20 
                days before the meeting;
            ``(11) furnish each advisory committee and its panels with 
        adequate clerical and other necessary assistance;
            ``(12) provide for the compensation of members of each 
        advisory committee and its panels (other than those in the full 
        time employ of the United States)--
                    ``(A) while attending meetings or otherwise engaged 
                in official business at rates to be fixed by the 
                Secretary, but not at rates exceeding the daily 
                equivalent of the rate in effect for level IV of the 
                Executive Schedule for each day so engaged, including 
                travel time; and
                    ``(B) while serving away from their homes or 
                regular places of business, of travel expenses 
                (including per diem in lieu of subsistence) as 
                authorized by section 5703 of Title 5, United States 
                Code, for persons in the Government service employed 
                intermittently;
            ``(13) provide for the panels to meet at least once every 3 
        months unless there is no business to conduct;
            ``(14) require each advisory committee and its panels to 
        provide, with any recommendation, a summary of the reasons for 
        the recommendation and a summary of the data upon which the 
        recommendation is based;
            ``(15) make a verbatim transcript of each advisory 
        committee and panel proceedings (other than those portions that 
        are closed to the public in accordance with law) available to 
        the public within 14 days on an official Internet site of the 
        Department of Health and Human Services; and
            ``(16) prescribe in regulations the procedures to be 
        followed by each advisory committee and its panels in making 
        their reviews and recommendations.
    ``(e) Definitions.--For purposes of this section--
            ``(1) the term `coding' means the assignment of 
        identification codes for medical equipment and supplies, items, 
        services, and other benefits under this title; and
            ``(2) the term `payment' means the determination of 
        appropriate payment amounts for medical equipment and supplies, 
        items, services, and other benefits under this title.''.
    (b) Transition, Continuing Responsibility for Unfinished Duties.--
            (1) Effective on the date the Medicare Access to Technology 
        Advisory Committee is established, the Secretary of Health and 
        Human Services shall provide for the transfer to such committee 
        of any assets and staff of the Medicare Coverage Advisory 
        Committee and the Medicare Payment and Coding Advisory 
        Committee, without any loss of benefits or seniority by virtue 
        of such transfers. Fund balances available to the Medicare 
        Coverage Advisory Committee or the Medicare Payment and Coding 
        Advisory Committee for any period shall be available to the 
        Medicare Access to Technology Advisory Committee for such 
        period for like purposes.
            (2) The Medicare Access to Technology Advisory Committee 
        shall be responsible for the preparation and submission of 
        reports and recommendations not yet submitted to the Secretary 
        by the Medicare Coverage Advisory Committee or the Medicare 
        Payment and Coding Advisory Committee upon the expiration of 
        those committees.
    (c) Reporting Requirements.--
            (1) Not later than April 1, 2000, the Secretary of Health 
        and Human Services shall submit to Congress a report certifying 
        that the committee and panels required to be established by 
        section 1897(b), as added by subsection (a), are operational.
            (2) Not later than September 1, 2003, the Secretary of 
        Health and Human Services shall submit to Congress a report 
        certifying that the committee and panels required to be 
        established by section 1897(c), as added by subsection (a), are 
        operational.
            (3) Not later than December 1 of each year beginning with 
        2000, the Secretary of Health and Human Services shall submit 
        to Congress a report describing the timeliness of the 
        Secretary's national coverage policy decision making during the 
        preceding fiscal year measured by the time frames the Secretary 
        has published for the national coverage policy determination 
        process, and such report shall include the actual time periods 
        that were necessary to complete and fully implement national 
        coverage policy determinations and each significant step in the 
        process.
            (4) Not later than July 1, 2000, the Secretary of Health 
        and Human Services shall submit to Congress a report, on the 
        nature of the coverage policy determination processes used by 
        Medicare+Choice organizations, under part C of title XVIII of 
        the Social Security Act, including a detailed explanation of 
        any steps taken to ensure that the coverage policy 
        determination processes under the Medicare+Choice program--
                    (A) produce results consistent with the coverage 
                policy determinations reached under parts A and B of 
                such title; and
                    (B) treat any medical device being investigated 
                under section 520(g) of the Federal Food, Drug, and 
                Cosmetic Act (42 U.S.C. 360j(g)), in a manner 
                consistent with the treatment afforded such medical 
                device under such parts.

SEC. 4. 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.--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), 1833(t), 
1848, and 1886(d), and the payment systems referred to in subsection 
(f), (including relative payment weights, relative value units, and 
weighting factors) at least annually to ensure that payments under such 
systems--
            ``(1) appropriately reflect changes in medical technology 
        and medical practice affecting the items and services for which 
        payment may be made under such systems; and
            ``(2) promote the efficient and effective delivery of high-
        quality health care.
    ``(b) Rules for Determining Adjustments.--Except as provided in 
subsection (c), the provisions of section 1833(i)(2)(A), section 
1833(t)(6), section 1848(c)(2)(B), and section 1886(d)(4)(C), and the 
appropriate provisions of the payments systems referred to in 
subsection (f), 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, 
and weighting factors, 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 subsection, 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. In no event may the 
        deadline established under this paragraph be more than 7 months 
        before the first day of the provider payment update period for 
        which the adjustment or adjustments to which the data relates 
        would be effective.
    ``(d) Use of External Data.--
            ``(1) In general.--Subject to paragraph (2), in determining 
        the adjustments required by this section, 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.--In determining the adjustments required by this section, 
        the Secretary may not--
                    ``(A) 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
                    ``(B) establish a uniform period of time (such as 
                one year) from which such data must be drawn.
            ``(3) Alternative sources of data.--In determining the 
        adjustments required by this section, the Secretary shall use 
        data, that otherwise meets 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), or under the payment systems 
                referred to in subsection (f), 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), or under the appropriate sections with 
                respect to the payment systems referred to in 
                subsection (f)) 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. 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 relates 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, 2000; 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), 
                1833(t), 1848, or 1886(d), or a payment system referred 
                to in subsection (f), 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 systems 
                established under section 1833(t) and section 1848, a 
                calendar year;
                    ``(B) in the case the payment systems established 
                under section 1833(i)(2)(A) and section 1886(d), a 
                fiscal year beginning on October 1; and
                    ``(C) in the case of a payment system referred to 
                in subsection (f), such calendar year or such fiscal 
                year, as determined by the Secretary.
    ``(f) Annual Updates for Other Medicare Payment Systems.--The 
provisions of subsection (a) shall apply to payment systems established 
under this title (other than those specified in subsection (a)) in the 
same manner as they apply to the payment systems specified in such 
subsection.''.
    (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) Outpatient hospital prospective payment system.--
        Section 1833(t)(6)(A) of such Act (42 U.S.C. 1395l(t)(6)(A)) is 
        amended by striking ``The'' and inserting ``Subject to section 
        1889, the''.
            (3) 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''.
            (4) 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. 5. PROCESS FOR MAKING AND IMPLEMENTING CERTAIN 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) accept recommendations for HCPCS level II code 
        modifications from the public throughout the year;
            (2) cause determinations on recommendations received during 
        the three months immediately preceding the last month of a 
        calendar quarter to be made not later than the first day of the 
        following calendar quarter; and
            (3) incorporate approved modifications to HCPCS level II 
        codes into the payment systems established under such title 
        (including the medicare fee schedule data base) not later than 
        180 days after the date on which the determination approving a 
        modification was made.
    (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 a 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 alpha-numeric 
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, 2000.

SEC. 6. RETENTION OF HCPCS LEVEL III CODES.

    (a) In General.--The Secretary of Health and Human Services shall 
maintain and continue the use of HCPCS level III codes (as 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 alpha-numeric codes for local use under the 
Health Care Financing Administration Common Procedure Coding System 
(HCPCS).
                                 <all>