HR 2030 IH

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.

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

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).

END