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42 U.S.C. § 1395aaa — Contract with a consensus-based enti-

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42 U.S.C. § 1395aaa — Contract with a consensus-based enti-

Page 3954 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa 1 See 2018 Amendment note below. spector General of Department of Health and Human Services or the Comptroller General of the United States. ‘‘(c) DESCRIPTION OF TECHNICAL ASSISTANCE.—The technical assistance provided under the demonstration program shall include a direct and in-person examina- tion of billing systems and internal controls of small providers of services or suppliers to determine program compliance and to suggest more efficient or effective means of achieving such compliance. ‘‘(d) GAO EVALUATION.—Not later than 2 years after the date the demonstration program is first imple- mented, the Comptroller General, in consultation with the Inspector General of the Department of Health and Human Services, shall conduct an evaluation of the demonstration program. The evaluation shall include a determination of whether claims error rates are re- duced for small providers of services or suppliers who participated in the program and the extent of improper payments made as a result of the demonstration pro- gram. The Comptroller General shall submit a report to the Secretary and the Congress on such evaluation and shall include in such report recommendations regard- ing the continuation or extension of the demonstration program. ‘‘(e) FINANCIAL PARTICIPATION BY PROVIDERS.—The provision of technical assistance to a small provider of services or supplier under the demonstration program is conditioned upon the small provider of services or supplier paying an amount estimated (and disclosed in advance of a provider’s or supplier’s participation in the program) to be equal to 25 percent of the cost of the technical assistance. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authoriz

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Page 3954 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa 1 See 2018 Amendment note below. spector General of Department of Health and Human Services or the Comptroller General of the United States. ‘‘(c) DESCRIPTION OF TECHNICAL ASSISTANCE.—The technical assistance provided under the demonstration program shall include a direct and in-person examina- tion of billing systems and internal controls of small providers of services or suppliers to determine program compliance and to suggest more efficient or effective means of achieving such compliance. ‘‘(d) GAO EVALUATION.—Not later than 2 years after the date the demonstration program is first imple- mented, the Comptroller General, in consultation with the Inspector General of the Department of Health and Human Services, shall conduct an evaluation of the demonstration program. The evaluation shall include a determination of whether claims error rates are re- duced for small providers of services or suppliers who participated in the program and the extent of improper payments made as a result of the demonstration pro- gram. The Comptroller General shall submit a report to the Secretary and the Congress on such evaluation and shall include in such report recommendations regard- ing the continuation or extension of the demonstration program. ‘‘(e) FINANCIAL PARTICIPATION BY PROVIDERS.—The provision of technical assistance to a small provider of services or supplier under the demonstration program is conditioned upon the small provider of services or supplier paying an amount estimated (and disclosed in advance of a provider’s or supplier’s participation in the program) to be equal to 25 percent of the cost of the technical assistance. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated, from amounts not other- wise appropriated in the Treasury, such sums as may be necessary to carry out this section.’’ § 1395aaa. Contract with a consensus-based enti- ty regarding performance measurement (a) Contract (1) In general 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 de- scribed in subsection (b). (2) Timing for first contract As soon as practicable after July 15, 2008, the Secretary shall enter into the first contract under paragraph (1). (3) Period of contract 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 Competitive procedures (as defined in sec- tion 132 of title 41) shall be used to enter into a contract under paragraph (1). (b) Duties The duties described in this subsection are the following: (1) Priority setting process The entity shall synthesize evidence and convene key stakeholders to make rec- ommendations, with respect to activities con- ducted under this chapter, on an integrated national strategy and priorities for health care performance measurement in all applica- ble settings. In making such recommenda- tions, the entity shall— (A) ensure that priority is given to meas- ures— (i) that address the health care provided to patients with prevalent, high-cost chronic diseases; (ii) with the greatest potential for im- proving the quality, efficiency, and pa- tient-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 pa- tient receives, including services furnished by multiple health care providers or prac- titioners and across multiple settings. (2) Endorsement of measures The entity shall provide for the endorsement of standardized health care performance meas- ures. The endorsement process under the pre- ceding sentence shall consider whether a measure— (A) is evidence-based, reliable, valid, verifiable, relevant to enhanced health out- comes, actionable at the caregiver level, fea- sible 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 phy- sicians. (3) Maintenance of measures 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) Removal of measures The entity may provide input to the Sec- retary on quality and efficiency measures de- scribed in paragraph (7)(B) that could be con- sidered for removal. (5) Annual report to Congress and the Sec- retary; secretarial publication and com- ment (A)1 Annual report By not later than March 1 of each year (be- ginning with 2009), the entity shall submit to Congress and the Secretary a report con- taining the following: (i) A description of— (I) the implementation of quality measurement initiatives under this chapter and the coordination of such ini- tiatives with quality initiatives imple- mented by other payers; (II) the recommendations made under paragraph (1); Page 3955 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa 2 So in original. Probably should be ‘‘panels).’’ 3 See References in Text note below. (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 un- available or inadequate to identify or ad- dress such gaps; (V) areas in which evidence is insuffi- cient to support endorsement of quality measures in priority areas identified by the Secretary under the national strat- egy 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 informa- tion for the fiscal year ending September 30 of the preceding year, including— (I) annual revenues of the entity (in- cluding any government funding, private sector contributions, grants, member- ship revenues, and investment revenue); (II) annual expenses of the entity (in- cluding grants paid, benefits paid, sala- ries or other compensation, fundraising expenses, and overhead costs); and (III) a breakdown of the amount award- ed per contracted task order and the spe- cific projects funded in each task order assigned to the entity. (iii) Any updates or modifications of in- ternal policies and procedures of the enti- ty as they relate to the duties of the enti- ty under this section, including— (I) specifically identifying any modi- fications to the disclosure of interests and conflicts of interests for commit- tees, work groups, task forces, and advi- sory panels of the entity; and (II) information on external stake- holder participation in the duties of the entity under this section (including com- plete 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.2 (B) Secretarial review and publication of an- nual report 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) Review and endorsement of episode group- er under the physician feedback program The entity shall provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary under sec- tion 1395w–4(n)(9)(A) of this title. Such review shall be conducted on an expedited basis. (7) Convening multi-stakeholder groups (A) In general The entity shall convene multi-stake- holder 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 en- dorsed by the entity; and (II) such measures that have not been considered for endorsement by such enti- ty but are used or proposed to be used by the Secretary for the collection or re- porting of quality and efficiency meas- ures; and (ii) national priorities (as identified under section 280j of this title) for im- provement in population health and in the delivery of health care services for consid- eration under the national strategy estab- lished under section 280j of this title. (B) Quality and efficiency measures (i) In general Subject to clause (ii), the quality and ef- ficiency measures described in this sub- paragraph are quality and efficiency meas- ures— (I) for use pursuant to sections 1395f(i)(5)(D), 1395l(i)(7), 1395l(t)(17), 1395w–4(k)(2)(C), 1395cc(k)(3), 1395rr(h)(2)(A)(iii),3 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) Exclusion Data sets (such as the outcome and as- sessment 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 ef- ficiency measures described in this sub- paragraph. (C) Requirement for transparency in process (i) In general In convening multi-stakeholder groups under subparagraph (A) with respect to the selection of quality and efficiency meas- ures, the entity shall provide for an open and transparent process for the activities conducted pursuant to such convening. Page 3956 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa (ii) Selection of organizations participating in multi-stakeholder groups The process described in clause (i) shall ensure that the selection of representa- tives comprising such groups provides for public nominations for, and the oppor- tunity for public comment on, such selec- tion. (D) Multi-stakeholder group defined In this paragraph, the term ‘‘multi-stake- holder group’’ means, with respect to a qual- ity and efficiency measure, a voluntary col- laborative of organizations representing a broad group of stakeholders interested in or affected by the use of such quality and effi- ciency measure. (8) Transmission of multi-stakeholder input Not later than February 1 of each year (be- ginning with 2012), the entity shall transmit to the Secretary the input of multi-stakeholder groups provided under paragraph (7). (9) Prioritization of measure endorsement The Secretary— (A) during the period beginning on Decem- ber 27, 2020, and ending on December 31, 2023, shall prioritize the endorsement of measures relating to maternal morbidity and mor- tality by the entity with a contract under subsection (a) in connection with endorse- ment 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) Requirements described The requirements described in this subsection are the following: (1) Private nonprofit The entity is a private nonprofit entity gov- erned by a board. (2) Board membership The members of the board of the entity in- clude— (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 representa- tives of groups representing health care con- sumers; and (C) representatives of purchasers and em- ployers or representatives of groups rep- resenting purchasers or employers. (3) Entity membership The membership of the entity includes per- sons 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) Open and transparent With respect to matters related to the con- tract with the Secretary under subsection (a), the entity conducts its business in an open and transparent manner and provides the oppor- tunity for public comment on its activities. (5) Voluntary consensus standards setting or- ganization The entity operates as a voluntary con- sensus standards setting organization as de- fined for purposes of section 12(d) of the Na- tional 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) Experience The entity has at least 4 years of experience in establishing national consensus standards. (7) Membership fees 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 indi- viduals or groups with low or nominal re- sources to participate in the functions of the entity. (d) Funding (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 propor- tion as the Secretary determines appropriate), of $10,000,000 to the Centers for Medicare & Med- icaid Services Program Management Account for each of fiscal years 2009 through 2013. Amounts transferred under the preceding sen- tence 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 pro- vide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical In- surance Trust Fund under section 1395t of this title, in such proportion as the Secretary deter- mines appropriate, to the Centers for Medicare & Medicaid Services Program Management Ac- count 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 fis- cal year 2021, $20,000,000 for fiscal year 2022, $20,000,000 for fiscal year 2023, and $11,030,000 for the period beginning on October 1, 2023, and end- ing on March 31, 2025. Amounts transferred under the preceding sentence shall remain avail- able until expended. Amounts transferred for each of fiscal years 2018, 2019, 2020, 2021, 2022, 2023, and 2024 and the period beginning on Octo- ber 1, 2024, and ending on March 31, 2025, shall be in addition to any unobligated funds transferred for a preceding fiscal year that are available under the preceding sentence. Page 3957 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa (e) Annual report by Secretary to Congress (1) In general By not later than March 1 of each year (be- ginning 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 con- tract under subsection (a) and any other en- tity the Secretary has contracted with or may contract with to perform work associ- ated with section 1395aaa–1 of this title to help meet those needs, specifically with re- spect 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 Sec- retary, the amount of funding provided that has been expended, and the amount of fund- ing 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 de- scribed 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 con- tracted with to perform work. (D) Subject to paragraph (2)(B), a descrip- tion of the activities for which the funds de- scribed in paragraph (2) were used, including task orders and activities assigned to the en- tity with a contract under subsection (a), ac- tivities 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 ex- penditures that the Secretary anticipates will be needed in the succeeding two year pe- riod to carry out each of the quality meas- urement activities required under this sec- tion and section 1395aaa–1 of this title, in- cluding any obligations that will require funds to be expended in a future year. (2) Additional requirements for reports (A) Addressing GAO report 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 Medi- care & Medicaid Services has addressed each of the recommendations set forth in the report by the Government Account- ability Office (GAO–19–628) issued on Sep- tember 19, 2019, and titled ‘‘Health Care Quality: CMS Could More Effectively En- sure Its Quality Measurement Activities Promote Its Objectives’’. (ii) A detailed description of— (I) any additional steps that the Cen- ters 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) Ensuring detailed information (i) In general In the case of an annual report sub- mitted in 2021 or a subsequent year pursu- ant to paragraph (1), the information re- quired under— (I) paragraph (1)(D) shall also include detailed information on each of the ac- tivities 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) Activities described 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) Additional reporting by the Secretary to Con- gress (1) In general By not later than September 30 of each year (beginning with 2021), the Secretary shall sub- mit to Congress a report on the amount of un- obligated balances for appropriations relating to quality measurement. Such report shall in- clude detailed plans on how the Secretary ex- pects to expend such unobligated balances in the upcoming fiscal years. (2) Separate report The annual report required under paragraph (1) shall be separate from the annual report re- quired under subsection (e). (Aug. 14, 1935, ch. 531, title XVIII, § 1890, as added Pub. L. 110–275, title I, § 183(a)(1), July 15, 2008, 122 Stat. 2583; amended Pub. L. 111–148, title III, §§ 3003(b), 3014(a), title X, §§ 10304, 10322(b), Mar. 23, 2010, 124 Stat. 367, 384, 938, 954; Pub. L. 112–240, title VI, § 609(a), Jan. 2, 2013, 126 Stat. 2349; Pub. L. 113–67, div. B, title I, § 1109, Dec. 26, 2013, 127 Stat. 1197; Pub. L. 113–93, title I, § 109, Apr. 1, 2014, 128 Stat. 1043; Pub. L. 114–10, title II, § 207, Apr. 16, 2015, 129 Stat. 145; Pub. L. 115–123, div. E, title II, § 50206(a)–(c)(1), Feb. 9, 2018, 132 Stat. 183–185; Pub. L. 116–59, div. B, title IV, § 1401, Sept. 27, 2019, 133 Stat. 1105; Pub. L. 116–69, div. B, title IV, § 1401(a), Nov. 21, 2019, 133 Stat. 1138; Pub. L. 116–94, div. N, title I, § 102(a), Dec. 20, 2019, 133 Stat. 3096; Pub. L. 116–136, div. A, title Page 3958 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa III, § 3802(a), Mar. 27, 2020, 134 Stat. 427; Pub. L. 116–159, div. C, title II, § 2202, Oct. 1, 2020, 134 Stat. 730; Pub. L. 116–215, div. B, title I, § 1103, Dec. 11, 2020, 134 Stat. 1042; Pub. L. 116–260, div. CC, title I, § 102, Dec. 27, 2020, 134 Stat. 2940; Pub. L. 118–42, div. G, title I, § 301, Mar. 9, 2024, 138 Stat. 414; Pub. L. 118–158, div. C, title II, § 3204, Dec. 21, 2024, 138 Stat. 1765.) Editorial Notes REFERENCES IN TEXT Clause (iii) of section 1395rr(h)(2)(A) of this title, re- ferred 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 en- acted 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 ex- cluded individuals and entities, was amended and trans- ferred 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 clas- sified to section 1395y(e)(2) of this title. AMENDMENTS 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 sub- stituted ‘‘2023, and 2024 and the period beginning on Oc- tober 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 De- cember 18, 2020, the amount equal to the pro rata por- tion of the amount appropriated for such period for fis- cal year 2020’’ in first sentence and ‘‘2020, 2021, 2022, and 2023’’ for ‘‘and 2020, and for the period beginning on Oc- tober 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 fis- cal 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 appro- priated for such period for fiscal year 2020’’ for ‘‘and $4,830,000 for the period beginning on October 1, 2019, and ending on May 22, 2020’’ in first sentence and ‘‘, 2019, and 2020, and for the period beginning on Octo- ber 1, 2020, and ending on November 30, 2020,’’ for ‘‘and 2019 and for the period beginning on October 1, 2019, and ending on May 22, 2020’’ in last sentence. Subsec. (e). Pub. L. 116–260, § 102(b)(1)(A), (B), (G), des- ignated existing provisions as par. (1), inserted heading, redesignated former pars. (1) to (6) as subpars. (A) to (F), respectively, of par. (1), and added par. (2). Subsec. (e)(1)(A). Pub. L. 116–260, § 102(b)(1)(C), struck out at end ‘‘In years after the first plan under this paragraph is submitted, the requirements of this para- graph may be met by providing an update to the plan.’’ Subsec. (e)(1)(D). Pub. L. 116–260, § 102(b)(1)(D), sub- stituted ‘‘Subject to paragraph (2)(B), a description’’ for ‘‘A description’’. Subsec. (e)(1)(E). Pub. L. 116–260, § 102(b)(1)(E), sub- stituted ‘‘Subject to paragraph (2)(B), the amount’’ for ‘‘The amount’’. Subsec. (e)(1)(F). Pub. L. 116–260, § 102(b)(1)(F), sub- stituted ‘‘Subject to paragraph (2)(B), estimates’’ for ‘‘Estimates’’. Subsec. (f). Pub. L. 116–260, § 102(b)(2), added subsec. (f). 2019—Subsec. (d)(2). Pub. L. 116–94 substituted ‘‘$4,830,000 for the period beginning on October 1, 2019, and ending on May 22, 2020’’ for ‘‘$1,665,000 for the pe- riod beginning on October 1, 2019, and ending on Decem- ber 20, 2019’’ in first sentence and ‘‘May 22, 2020’’ for ‘‘December 20, 2019,’’ in last sentence. Pub. L. 116–69 substituted ‘‘$1,665,000 for the period beginning on October 1, 2019, and ending on December 20, 2019’’ for ‘‘$1,069,000 for the period beginning on Oc- tober 1, 2019, and ending on November 21, 2019’’ in first sentence and ‘‘December 20, 2019’’ for ‘‘November 21, 2019’’ in last sentence. Pub. L. 116–59 substituted ‘‘$7,500,000 for each of fiscal years 2018 and 2019, and $1,069,000 for the period begin- ning on October 1, 2019, and ending on November 21, 2019’’ for ‘‘and $7,500,000 for each of fiscal years 2018 and 2019’’ in first sentence and inserted ‘‘and for the period beginning on October 1, 2019, and ending on November 21, 2019,’’ after ‘‘2018 and 2019’’ in last sentence. 2018—Subsec. (b)(5)(A). Pub. L. 115–123, § 50206(c)(1), substituted ‘‘containing the following:’’ for ‘‘containing a description of—’’ in introductory provisions, inserted ‘‘(i) A description of—’’, redesignated former cls. (i) to (vi) as subcls. (I) to (VI), respectively, of cl. (i), re- aligned margins, and added cls. (ii) and (iii). Subsec. (d)(2). Pub. L. 115–123, § 50206(a), substituted ‘‘2014,’’ for ‘‘2014 and’’ and inserted ‘‘, and $7,500,000 for each of fiscal years 2018 and 2019’’ after ‘‘through 2017’’ and ‘‘Amounts transferred for each of fiscal years 2018 and 2019 shall be in addition to any unobligated funds transferred for a preceding fiscal year that are avail- able under the preceding sentence.’’ after ‘‘until ex- pended.’’ Subsec. (e). Pub. L. 115–123, § 50206(b), added subsec. (e). 2015—Subsec. (d)(2). Pub. L. 114–10 substituted ‘‘and $30,000,000 for each of fiscal years 2015 through 2017’’ for ‘‘and $15,000,000 for the first 6 months of fiscal year 2015’’. 2014—Subsec. (d). Pub. L. 113–93 designated existing provisions as par. (1) and added par. (2). 2013—Subsec. (b)(4). Pub. L. 112–240, § 609(a)(2), struck out par. (4). Text read as follows: ‘‘The entity shall pro- mote the development and use of electronic health records that contain the functionality for automated collection, aggregation, and transmission of perform- ance measurement information.’’ Subsec. (d). Pub. L. 113–67 inserted at end ‘‘Amounts transferred under the preceding sentence shall remain available until expended.’’ Pub. L. 112–240, § 609(a)(1), substituted ‘‘fiscal years 2009 through 2013’’ for ‘‘fiscal years 2009 through 2012’’. 2010—Subsec. (b)(5)(A)(iv) to (vi). Pub. L. 111–148, § 3014(a)(2), added cls. (iv) to (vi). Subsec. (b)(6). Pub. L. 111–148, § 3003(b), added par. (6). Subsec. (b)(7). Pub. L. 111–148, § 10304, substituted ‘‘quality and efficiency’’ for ‘‘quality’’ wherever ap- pearing in text. Pub. L. 111–148, § 3014(a)(1), added par. (7). Page 3959 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aaa–1 Subsec. (b)(7)(B). Pub. L. 111–148, § 10304, which di- rected substitution of ‘‘quality and efficiency’’ for ‘‘quality’’ wherever appearing, was executed by sub- stituting ‘‘Quality and efficiency’’ for ‘‘Quality’’ in sub- par. heading to reflect the probable intent of Congress. Subsec. (b)(7)(B)(i)(I). Pub. L. 111–148, § 10322(b), in- serted ‘‘1395ww(s)(4)(D),’’ after ‘‘1395ww(o)(2),’’. Subsec. (b)(8). Pub. L. 111–148, § 3014(a)(1), added par. (8). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2020 AMENDMENT Pub. L. 116–136, div. A, title III, § 3802(b), Mar. 27, 2020, 134 Stat. 427, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of the Further Consoli- dated Appropriations Act, 2020 (Public Law 116–94).’’ EFFECTIVE DATE OF 2019 AMENDMENT Pub. L. 116–94, div. N, title I, § 102(b), Dec. 20, 2019, 133 Stat. 3096, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of the Further Con- tinuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 (Public Law 116–69).’’ Pub. L. 116–69, div. B, title IV, § 1401(b), Nov. 21, 2019, 133 Stat. 1138, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall take ef- fect as if included in the enactment of the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Public Law 116–59).’’ EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115–123, div. E, title II, § 50206(c)(2), Feb. 9, 2018, 132 Stat. 185, provided that: ‘‘The amendments made by this subsection [amending this section] shall apply to reports submitted for years beginning with 2019.’’ § 1395aaa–1. Quality and efficiency measurement (a) Multi-stakeholder group input into selection of quality and efficiency measures The Secretary shall establish a pre-rule- making process under which the following steps occur with respect to the selection of quality and efficiency measures described in section 1395aaa(b)(7)(B) of this title: (1) Input Pursuant to section 1395aaa(b)(7) of this title, the entity with a contract under section 1395aaa of this title shall convene multi-stake- holder groups to provide input to the Sec- retary on the selection of quality and effi- ciency measures described in subparagraph (B) of such paragraph. (2) Public availability of measures considered for selection Not later than December 1 of each year (be- ginning with 2011), the Secretary shall make available to the public a list of quality and ef- ficiency measures described in section 1395aaa(b)(7)(B) of this title that the Secretary is considering under this subchapter. (3) Transmission of multi-stakeholder input Pursuant to section 1395aaa(b)(8) of this title, not later than February 1 of each year (beginning with 2012), the entity shall trans- mit to the Secretary the input of multi-stake- holder groups described in paragraph (1). (4) Consideration of multi-stakeholder input The Secretary shall take into consideration the input from multi-stakeholder groups de- scribed in paragraph (1) in selecting quality and efficiency measures described in section 1395aaa(b)(7)(B) of this title that have been en- dorsed by the entity with a contract under section 1395aaa of this title and measures that have not been endorsed by such entity. (5) Rationale for use of quality and efficiency measures The Secretary shall publish in the Federal Register the rationale for the use of any qual- ity and efficiency measure described in section 1395aaa(b)(7)(B) of this title that has not been endorsed by the entity with a contract under section 1395aaa of this title. (6) Assessment of impact Not later than March 1, 2012, and at least once every three years thereafter, the Sec- retary shall— (A) conduct an assessment of the quality and efficiency impact of the use of endorsed measures described in section 1395aaa(b)(7)(B) of this title; and (B) make such assessment available to the public. (b) Process for dissemination of measures used by the Secretary (1) In general The Secretary shall establish a process for disseminating quality and efficiency measures used by the Secretary. Such process shall in- clude the following: (A) The incorporation of such measures, where applicable, in workforce programs, training curricula, and any other means of dissemination determined appropriate by the Secretary. (B) The dissemination of such quality and efficiency measures through the national strategy developed under section 280j of this title. (2) Existing methods To the extent practicable, the Secretary shall utilize and expand existing dissemina- tion methods in disseminating quality and ef- ficiency measures under the process estab- lished under paragraph (1). (c) Review of quality and efficiency measures used by the Secretary (1) In general The Secretary shall— (A) periodically (but in no case less often than once every 3 years) review quality and efficiency measures described in section 1395aaa(b)(7)(B) of this title; and (B) with respect to each such measure, de- termine whether to— (i) maintain the use of such measure; or (ii) phase out such measure. (2) Considerations In conducting the review under paragraph (1), the Secretary shall take steps to— (A) seek to avoid duplication of measures used; and (B) take into consideration current inno- vative methodologies and strategies for quality and efficiency improvement prac-

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395aaa — Limitation on liability where claims are disallowed

**(a) Conditions prerequisite to payment for items and services notwithstanding determination of disallowance** Where— (1) a determination is made that, by reason of section 1395y(a)(1) or (9) of this title or by reason of a coverage denial described in subsection (g), payment may not be made under part A or part B of this subchapter for any expenses incurred for items or services furnished an individual by a provider of services or by another person pursuant to an assignment under [section 1395u(b)(3)(B)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395u/b/3/B/ii&num=0&edition=prelim), and (2) both such individual and such provider of services or such other person, as the case may be, did not know, and could not reasonably have been expected to know, that payment would not be made for such items or services under such part A or part B, then to the extent permitted by this subchapter, payment shall, notwithstanding such determination, be made for such items or services (and for such period of time as the Secretary finds will carry out the objectives of this subchapter), as though section 1395y(a)(1) and [section 1395y(a)(9) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395y/a/9&num=0&edition=prelim) did not apply and as though the coverage denial described in subsection (g) had not occurred. In each such case the Secretary shall notify both such individual and such provider of services or such other person, as the case may be, of the conditions under which payment for such items or services was made and in the case of comparable situations arising thereafter with respect to such individual or such provider or such other person, each shall, by reason of such notice (or simil

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