§1395aaa — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary must hire and keep under contract a private, consensus-based group (for example, the National Quality Forum) to lead national work on measuring health care performance. The first contract had to be started as soon as possible after July 15, 2008. Each contract lasts 4 years unless renewed after a new bidding process. Competitive bidding rules must be used. The group must study the evidence, bring together key people, and make recommendations on a national plan and priorities for performance measures across settings. It must focus first on measures that target common, high-cost chronic diseases, measures likely to improve quality, efficiency, and patient-centered care, and measures that can be used quickly. It must also consider measures that help patients choose care, reduce health disparities, and cover the full course of care across different providers and places. The group must endorse standard measures after reviewing whether they are evidence-based, reliable, valid, verifiable, linked to better outcomes, useful to clinicians, feasible to collect, fair across patient differences, and consistent across provider types. Endorsed measures must be updated or retired as new evidence appears. The group will review an “episode grouper” made by the Secretary quickly, and it may advise on removing measures. The group must form multi-stakeholder teams, with an open process and public nominations and comment, to advise on selecting quality and efficiency measures used by Medicare and for public reporting; the group must send that stakeholder input to the Secretary by February 1 each year starting in 2012. From December 27, 2020 through December 31, 2023 the Secretary must prioritize endorsement of measures about maternal morbidity and mortality; starting January 1, 2024 the Secretary may continue that priority. The group must be a nonprofit with a board that includes health plan and provider representatives, consumer representatives, and purchaser/employer representatives. Its members must include people with experience in urban care, safety-net care, rural and frontier care, and quality and safety. It must run openly, allow public comment, act as a voluntary consensus standards organization under applicable federal guidance, and have at least 4 years’ experience in setting national standards. Any membership fees must be reasonable so low-resource participants can join. Funding is provided by transfers from the Hospital Insurance and Supplementary Medical Insurance Trust Funds to the CMS Program Management Account: $10,000,000 each fiscal year 2009–2013; $5,000,000 for 2014; $30,000,000 each fiscal year 2015–2017; $7,500,000 each for 2018 and 2019; $20,000,000 for 2020; $26,000,000 for 2021; $20,000,000 for 2022; $20,000,000 for 2023; $14,030,000 for Oct 1, 2023–Sep 30, 2025; $13,300,000 for 2026; and $15,100,000 for 2027. These funds remain available until spent, and later year amounts are in addition to any unused prior-year funds. The Secretary must publish an annual report to Congress by March 1 (beginning 2019) describing a plan for quality measurement needs, how funds were obligated and spent, task orders and activities, and two-year funding needs; 2021 and 2022 reports must also analyze a specific GAO report (GAO–19–628) and list steps and timing to address it. A separate annual report on unobligated balances and spending plans is required by September 30 each year starting 2021.

Title 42, §1395aaa

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)For purposes of activities conducted under this chapter, the Secretary shall identify and have in effect a contract with a consensus-based entity, such as the National Quality Forum, that meets the requirements described in subsection (c). Such contract shall provide that the entity will perform the duties described in subsection (b).

(2)As soon as practicable after July 15, 2008, the Secretary shall enter into the first contract under paragraph (1).

(3)A contract under paragraph (1) shall be for a period of 4 years (except as may be renewed after a subsequent bidding process).

(4)Competitive procedures (as defined in section 132 of title 41) shall be used to enter into a contract under paragraph (1).

(b)The duties described in this subsection are the following:

(1)The entity shall synthesize evidence and convene key stakeholders to make recommendations, with respect to activities conducted under this chapter, on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In making such recommendations, the entity shall—

(A)ensure that priority is given to measures—

(i)that address the health care provided to patients with prevalent, high-cost chronic diseases;

(ii)with the greatest potential for improving the quality, efficiency, and patient-centeredness of health care; and

(iii)that may be implemented rapidly due to existing evidence, standards of care, or other reasons; and

(B)take into account measures that—

(i)may assist consumers and patients in making informed health care decisions;

(ii)address health disparities across groups and areas; and

(iii)address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings.

(2)The entity shall provide for the endorsement of standardized health care performance measures. The endorsement process under the preceding sentence shall consider whether a measure—

(A)is evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics, such as health status, language capabilities, race or ethnicity, and income level; and

(B)is consistent across types of health care providers, including hospitals and physicians.

(3)The entity shall establish and implement a process to ensure that measures endorsed under paragraph (2) are updated (or retired if obsolete) as new evidence is developed.

(4)The entity may provide input to the Secretary on quality and efficiency measures described in paragraph (7)(B) that could be considered for removal.

(5)(A)By not later than March 1 of each year (beginning with 2009), the entity shall submit to Congress and the Secretary a report containing the following:

(i)A description of—

(I)the implementation of quality measurement initiatives under this chapter and the coordination of such initiatives with quality initiatives implemented by other payers;

(II)the recommendations made under paragraph (1);

(III)the performance by the entity of the duties required under the contract entered into with the Secretary under subsection (a);

(IV)gaps in endorsed quality measures, which shall include measures that are within priority areas identified by the Secretary under the national strategy established under section 280j of this title, and where quality measures are unavailable or inadequate to identify or address such gaps;

(V)areas in which evidence is insufficient to support endorsement of quality measures in priority areas identified by the Secretary under the national strategy established under section 280j of this title and where targeted research may address such gaps; and

(VI)the matters described in clauses (i) and (ii) of paragraph (7)(A).

(ii)An itemization of financial information for the fiscal year ending September 30 of the preceding year, including—

(I)annual revenues of the entity (including any government funding, private sector contributions, grants, membership revenues, and investment revenue);

(II)annual expenses of the entity (including grants paid, benefits paid, salaries or other compensation, fundraising expenses, and overhead costs); and

(III)a breakdown of the amount awarded per contracted task order and the specific projects funded in each task order assigned to the entity.

(iii)Any updates or modifications of internal policies and procedures of the entity as they relate to the duties of the entity under this section, including—

(I)specifically identifying any modifications to the disclosure of interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity; and

(II)information on external stakeholder participation in the duties of the entity under this section (including complete rosters for all committees, work groups, task forces, and advisory panels funded through government contracts, descriptions of relevant interests and any conflicts of interest for members of all committees, work groups, task forces, and advisory panels, and the total percentage by health care sector of all convened committees, work groups, task forces, and advisory panels.22 So in original. Probably should be “panels).”

(B)Not later than 6 months after receiving a report under subparagraph (A) for a year, the Secretary shall—

(i)review such report; and

(ii)publish such report in the Federal Register, together with any comments of the Secretary on such report.

(6)The entity shall provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary under section 1395w–4(n)(9)(A) of this title. Such review shall be conducted on an expedited basis.

(7)(A)The entity shall convene multi-stakeholder groups to provide input on—

(i)the selection of quality and efficiency measures described in subparagraph (B), from among—

(I)such measures that have been endorsed by the entity; and

(II)such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and

(ii)national priorities (as identified under section 280j of this title) for improvement in population health and in the delivery of health care services for consideration under the national strategy established under section 280j of this title.

(B)(i)Subject to clause (ii), the quality and efficiency measures described in this subparagraph are quality and efficiency measures—

(I)for use pursuant to section 1395f(i)(5)(D), 1395l(i)(7), 1395l(t)(17), 1395w–4(k)(2)(C), 1395cc(k)(3), 1395rr(h)(2)(A)(iii),33 See References in Text note below. 1395ww(b)(3)(B)(viii), 1395ww(j)(7)(D), 1395ww(m)(5)(D), 1395ww(o)(2), 1395ww(s)(4)(D), and 1395fff(b)(3)(B)(v) of this title;

(II)for use in reporting performance information to the public; and

(III)for use in health care programs other than for use under this chapter.

(ii)Data sets (such as the outcome and assessment information set for home health services and the minimum data set for skilled nursing facility services) that are used for purposes of classification systems used in establishing payment rates under this subchapter shall not be quality and efficiency measures described in this subparagraph.

(C)(i)In convening multi-stakeholder groups under subparagraph (A) with respect to the selection of quality and efficiency measures, the entity shall provide for an open and transparent process for the activities conducted pursuant to such convening.

(ii)The process described in clause (i) shall ensure that the selection of representatives comprising such groups provides for public nominations for, and the opportunity for public comment on, such selection.

(D)In this paragraph, the term “multi-stakeholder group” means, with respect to a quality and efficiency measure, a voluntary collaborative of organizations representing a broad group of stakeholders interested in or affected by the use of such quality and efficiency measure.

(8)Not later than February 1 of each year (beginning with 2012), the entity shall transmit to the Secretary the input of multi-stakeholder groups provided under paragraph (7).

(9)The Secretary—

(A)during the period beginning on December 27, 2020, and ending on December 31, 2023, shall prioritize the endorsement of measures relating to maternal morbidity and mortality by the entity with a contract under subsection (a) in connection with endorsement of measures described in paragraph (2); and

(B)on and after January 1, 2024, may prioritize the endorsement of such measures by such entity.

(c)The requirements described in this subsection are the following:

(1)The entity is a private nonprofit entity governed by a board.

(2)The members of the board of the entity include—

(A)representatives of health plans and health care providers and practitioners or representatives of groups representing such health plans and health care providers and practitioners;

(B)health care consumers or representatives of groups representing health care consumers; and

(C)representatives of purchasers and employers or representatives of groups representing purchasers or employers.

(3)The membership of the entity includes persons who have experience with—

(A)urban health care issues;

(B)safety net health care issues;

(C)rural and frontier health care issues; and

(D)health care quality and safety issues.

(4)With respect to matters related to the contract with the Secretary under subsection (a), the entity conducts its business in an open and transparent manner and provides the opportunity for public comment on its activities.

(5)The entity operates as a voluntary consensus standards setting organization as defined for purposes of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (Public Law 104–113) and Office of Management and Budget Revised Circular A–119 (published in the Federal Register on February 10, 1998).

(6)The entity has at least 4 years of experience in establishing national consensus standards.

(7)If the entity requires a membership fee for participation in the functions of the entity, such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources to participate in the functions of the entity.

(d)(1)For purposes of carrying out this section, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title (in such proportion as the Secretary determines appropriate), of $10,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2009 through 2013. Amounts transferred under the preceding sentence shall remain available until expended.

(2)For purposes of carrying out this section and section 1395aaa–1 of this title (other than subsections (e) and (f)), the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, in such proportion as the Secretary determines appropriate, to the Centers for Medicare & Medicaid Services Program Management Account of $5,000,000 for fiscal year 2014, $30,000,000 for each of fiscal years 2015 through 2017, $7,500,000 for each of fiscal years 2018 and 2019, $20,000,000 for fiscal year 2020, $26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 2022, $20,000,000 for fiscal year 2023, $14,030,000 for the period beginning on October 1, 2023, and ending on September 30, 2025, $13,300,000 for fiscal year 2026, and $15,100,000 for fiscal year 2027. Amounts transferred under the preceding sentence shall remain available until expended. Amounts transferred for each of fiscal years 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, and 2027 shall be in addition to any unobligated funds transferred for a preceding fiscal year that are available under the preceding sentence.

(e)(1)By not later than March 1 of each year (beginning with 2019), the Secretary shall submit to Congress a report containing the following:

(A)A comprehensive plan that identifies the quality measurement needs of programs and initiatives of the Secretary and provides a strategy for using the entity with a contract under subsection (a) and any other entity the Secretary has contracted with or may contract with to perform work associated with section 1395aaa–1 of this title to help meet those needs, specifically with respect to the programs under this subchapter and subchapter XIX.

(B)The amount of funding provided under subsection (d) for purposes of carrying out this section and section 1395aaa–1 of this title that has been obligated by the Secretary, the amount of funding provided that has been expended, and the amount of funding provided that remains unobligated.

(C)With respect to the activities described under this section or section 1395aaa–1 of this title, a description of how the funds described in paragraph (2) have been obligated or expended, including how much of that funding has been obligated or expended for work performed by the Secretary, the entity with a contract under subsection (a), and any other entity the Secretary has contracted with to perform work.

(D)Subject to paragraph (2)(B), a description of the activities for which the funds described in paragraph (2) were used, including task orders and activities assigned to the entity with a contract under subsection (a), activities performed by the Secretary, and task orders and activities assigned to any other entity the Secretary has contracted with to perform work related to carrying out section 1395aaa–1 of this title.

(E)Subject to paragraph (2)(B), the amount of funding described in paragraph (2) that has been obligated or expended for each of the activities described in paragraph (4).

(F)Subject to paragraph (2)(B), estimates for, and descriptions of, obligations and expenditures that the Secretary anticipates will be needed in the succeeding two year period to carry out each of the quality measurement activities required under this section and section 1395aaa–1 of this title, including any obligations that will require funds to be expended in a future year.

(2)(A)Each of the annual reports submitted in 2021 and 2022 pursuant to paragraph (1) shall also include the following:

(i)A comprehensive analysis detailing the ways in which the Centers for Medicare & Medicaid Services has addressed each of the recommendations set forth in the report by the Government Accountability Office (GAO–19–628) issued on September 19, 2019, and titled “Health Care Quality: CMS Could More Effectively Ensure Its Quality Measurement Activities Promote Its Objectives”.

(ii)A detailed description of—

(I)any additional steps that the Centers for Medicare & Medicaid Services expects to take to address the findings and recommendations set forth in such report; and

(II)the anticipated timing for such steps.

(B)(i)In the case of an annual report submitted in 2021 or a subsequent year pursuant to paragraph (1), the information required under—

(I)paragraph (1)(D) shall also include detailed information on each of the activities described in clause (ii);

(II)paragraph (1)(E) shall also include detailed information on the specific amounts obligated or expended on each of the activities described in clause (ii); and

(III)paragraph (1)(F) shall also include detailed information on the specific quality measurement activities required and future funding needed for each of the activities described in clause (ii).

(ii)The activities described in this clause are the following:

(I)Measure selection activities.

(II)Measure development activities.

(III)Public reporting activities.

(IV)Education and outreach activities.

(f)(1)By not later than September 30 of each year (beginning with 2021), the Secretary shall submit to Congress a report on the amount of unobligated balances for appropriations relating to quality measurement. Such report shall include detailed plans on how the Secretary expects to expend such unobligated balances in the upcoming fiscal years.

(2)The annual report required under paragraph (1) shall be separate from the annual report required under subsection (e).

Notes & Related Subsidiaries

Editorial Notes

References in Text

Clause (iii) of section 1395rr(h)(2)(A) of this title, referred to in subsec. (b)(7)(B)(i)(I), was redesignated clause (iv) by Pub. L. 113–93, title II, § 217(d)(1)(B), Apr. 1, 2014, 128 Stat. 1062. section 12(d) of the National Technology Transfer and Advancement Act of 1995, referred to in subsec. (c)(5), is section 12(d) of Pub. L. 104–113, which is set out as a note under section 272 of Title 15, Commerce and Trade. Codification In subsec. (a)(4), “section 132 of title 41” substituted for “section 4(5) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(5))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Prior Provisions

A prior section 1395aaa, act Aug. 14, 1935, ch. 531, title XVIII, § 1890, as added Aug. 18, 1987, Pub. L. 100–93, § 10, 101 Stat. 696, which related to limitation of liability of beneficiaries with respect to services furnished by excluded individuals and entities, was amended and transferred to section 1862(e)(2) of act Aug. 14, 1935, by Pub. L. 100–360, title IV, § 411(i)(4)(D)(ii), July 1, 1988, 102 Stat. 790, as amended by Pub. L. 100–485, title VI, § 608(d)(24)(C)(ii), Oct. 13, 1988, 102 Stat. 2421, and is classified to section 1395y(e)(2) of this title.

Amendments

2026—Subsec. (d)(2). Pub. L. 119–75, § 6205, substituted “$13,300,000 for fiscal year 2026, and $15,100,000 for fiscal year 2027” for “and $13,300,000 for fiscal year 2026” and “2026, and 2027” for “and 2026”. 2025—Subsec. (d)(2). Pub. L. 119–37 substituted “$14,030,000” for “and $14,030,000” and inserted “, and $13,300,000 for fiscal year 2026” before period at end in first sentence and substituted “2024, 2025, and 2026” for “and 2024 and the period beginning on

October 1, 2024, and ending on

September 30, 2025,” in last sentence. Pub. L. 119–4 substituted “$14,030,000” for “$11,030,000” and substituted “

September 30, 2025” for “

March 31, 2025” in two places. 2024—Subsec. (d)(2). Pub. L. 118–158 substituted “$11,030,000” for “$9,000,000” and substituted “

March 31, 2025” for “

December 31, 2024” in two places. Pub. L. 118–42 substituted “$20,000,000” for “and $20,000,000” and inserted “, and $9,000,000 for the period beginning on

October 1, 2023, and ending on

December 31, 2024” before period at end in first sentence and substituted “2023, and 2024 and the period beginning on

October 1, 2024, and ending on

December 31, 2024” for “and 2023” in last sentence. 2020—Subsec. (b)(4). Pub. L. 116–260, § 102(c), added par. (4). Subsec. (b)(9). Pub. L. 116–260, § 102(d), added par. (9). Subsec. (d)(2). Pub. L. 116–260, § 102(a), substituted “$26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 2022, and $20,000,000 for fiscal year 2023” for “and for the period beginning on

October 1, 2020, and ending on

December 18, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020” in first sentence and “2020, 2021, 2022, and 2023” for “and 2020, and for the period beginning on

October 1, 2020, and ending on

December 18, 2020” in last sentence. Pub. L. 116–215 substituted “

December 18, 2020” for “

December 11, 2020” in two places. Pub. L. 116–159 substituted “

December 11, 2020” for “

November 30, 2020” in two places. Pub. L. 116–136, § 3802, substituted “$20,000,000 for fiscal year 2020, and for the period beginning on

October 1, 2020, and ending on

November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020” for “and $4,830,000 for the period beginning on