Friday, January 10, 2020

PL 116-94: Extension of PCORI


https://www.congress.gov/bill/116th-congress/house-bill/1865/text

Division N, Title 1, Subtitle A, Section 104



SEC. 104. EXTENSION OF APPROPRIATIONS TO THE PATIENT-CENTERED 
      OUTCOMES RESEARCH TRUST FUND; EXTENSION OF CERTAIN HEALTH 
      INSURANCE FEES.
    (a) In General.--Section 9511 of the Internal Revenue Code of 1986 
is amended--
        (1) in subsection (b)--
            (A) in paragraph (1)--
                (i) by inserting after subparagraph (E) the following 
            new subparagraph:
            ``(F) For each of fiscal years 2020 through 2029--
                ``(i) an amount equivalent to the net revenues received 
            in the Treasury from the fees imposed under subchapter B of 
            chapter 34 (relating to fees on health insurance and self-
            insured plans) for such fiscal year; and
                ``(ii) the applicable amount (as defined in paragraph 
            (4)) for the fiscal year.''; and
                (ii) by striking ``and (E)(ii)'' in the last sentence 
            and inserting ``(E)(ii), and (F)(ii)''; and
            (B) by adding at the end the following new paragraph:
        ``(4) Applicable amount defined.--In paragraph (1)(F)(ii), the 
    term `applicable amount' means--
            ``(A) for fiscal year 2020, $275,500,000;
            ``(B) for fiscal year 2021, $285,000,000;
            ``(C) for fiscal year 2022, $293,500,000;
            ``(D) for fiscal year 2023, $311,500,000;
            ``(E) for fiscal year 2024, $320,000,000;
            ``(F) for fiscal year 2025, $338,000,000;
            ``(G) for fiscal year 2026, $355,500,000;
            ``(H) for fiscal year 2027, $363,500,000;
            ``(I) for fiscal year 2028, $381,000,000; and
            ``(J) for fiscal year 2029, $399,000,000.'';
        (2) in subsection (d)(2)(A), by striking ``2019'' and inserting 
    ``2029''; and
        (3) in subsection (f), by striking ``December 20, 2019'' and 
    inserting ``September 30, 2029''.
    (b) Health Insurance Policies.--Section 4375(e) of the Internal 
Revenue Code of 1986 is amended by striking ``2019'' and inserting 
``2029''.
    (c) Self-insured Health Plans.--Section 4376(e) of the Internal 
Revenue Code of 1986 is amended by striking ``2019'' and inserting 
``2029''.
    (d) Identification of Research Priorities.--Subsection (d)(1)(A) of 
section 1181 of the Social Security Act (42 U.S.C. 1320e) is amended by 
adding at the end the following: ``Such national priorities shall 
include research with respect to intellectual and developmental 
disabilities and maternal mortality. Such priorities should reflect a 
balance between long-term priorities and short-term priorities, and be 
responsive to changes in medical evidence and in health care 
treatments.''.
    (e) Consideration of Full Range of Outcomes Data.--Subsection 
(d)(2) of such section 1181 is amended by adding at the end the 
following subparagraph:
            ``(F) Consideration of full range of outcomes data.--
        Research shall be designed, as appropriate, to take into 
        account and capture the full range of clinical and patient-
        centered outcomes relevant to, and that meet the needs of, 
        patients, clinicians, purchasers, and policy-makers in making 
        informed health decisions. In addition to the relative health 
        outcomes and clinical effectiveness, clinical and patient-
        centered outcomes shall include the potential burdens and 
        economic impacts of the utilization of medical treatments, 
        items, and services on different stakeholders and decision-
        makers respectively. These potential burdens and economic 
        impacts include medical out-of-pocket costs, including health 
        plan benefit and formulary design, non-medical costs to the 
        patient and family, including caregiving, effects on future 
        costs of care, workplace productivity and absenteeism, and 
        healthcare utilization.''.
    (f) Board Composition.--Subsection (f) of such section 1181 is 
amended--
        (1) in paragraph (1)--
            (A) in subparagraph (C)--
                (i) in the matter preceding clause (i)--

                    (I) by striking ``Seventeen'' and inserting ``At 
                least nineteen, but no more than twenty-one''; and
                    (II) by striking ``, not later than 6 months after 
                the date of enactment of this section,''; and

                (ii) in clause (iii), by striking ``3'' and inserting 
            ``at least 3, but no more than 5''; and
        (2) in paragraph (3)--
            (A) in the first sentence--
                (i) by striking the ``the members'' and inserting 
            ``members''; and
                (ii) by inserting the following before the period at 
            the end: ``to the extent necessary to preserve the evenly 
            staggered terms of the Board.''; and
            (B) by inserting the following after the first sentence: 
        ``Any member appointed to fill a vacancy occurring before the 
        expiration of the term for which the member's predecessor was 
        appointed shall be appointed for the remainder of that term and 
        thereafter may be eligible for reappointment to a full term. A 
        member may serve after the expiration of that member's term 
        until a successor has been appointed.''.
    (g) Methodology Committee Appointments.--Such section 1181 is 
amended--
        (1) in subsection (d)(6)(B), by striking ``Comptroller General 
    of the United States'' and inserting ``Board''; and
        (2) in subsection (h)(4)--
            (A) in subparagraph (A)(ii), by striking ``Comptroller 
        General'' and inserting ``Board''; and
            (B) in the first sentence of subparagraph (B), by striking 
        ``and of the Government Accountability Office''.
    (h) Reports by the Comptroller General of the United States.--
Subsection (g)(2)(A) of such section 1181 is amended--
        (1) by striking clause (iv) and inserting the following:
                ``(iv) Not less frequently than every 5 years, the 
            overall effectiveness of activities conducted under this 
            section and the dissemination, training, and capacity 
            building activities conducted under section 937 of the 
            Public Health Service Act. Such review shall include the 
            following:

                    ``(I) A description of those activities and the 
                financial commitments related to research, training, 
                data capacity building, and dissemination and uptake of 
                research findings.
                    ``(II) The extent to which the Institute and the 
                Agency for Healthcare Research and Quality have 
                collaborated with stakeholders, including provider and 
                payer organizations, to facilitate the dissemination 
                and uptake of research findings.
                    ``(III) An analysis of available data and 
                performance metrics, such as the estimated public 
                availability and dissemination of research findings and 
                uptake and utilization of research findings in clinical 
                guidelines and decision support tools, on the extent to 
                which such research findings are used by health care 
                decision-makers, the effect of the dissemination of 
                such findings on changes in medical practice and 
                reducing practice variation and disparities in health 
                care, and the effect of the research conducted and 
                disseminated on innovation and the health care economy 
                of the United States.''; and

        (2) by adding at the end the following new clause:
                ``(vi) Not less frequently than every 5 years, any 
            barriers that researchers funded by the Institute have 
            encountered in conducting studies or clinical trials, 
            including challenges covering the cost of any medical 
            treatments, services, and items described in subsection 
            (a)(2)(B) for purposes of the research study.''.

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