I 117th CONGRESS 1st Session H. R. 5125 IN THE HOUSE OF REPRESENTATIVES August 27, 2021 Mr. Smith of Nebraska (for himself, Mr. Buchanan , Mr. Wenstrup , and Mr. Smith of Missouri ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means , and Rules , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XI of the Social Security Act to clarify parameters for model testing and add accountability to model expansion under the Center for Medicare and Medicaid Innovation, and for other purposes.

1. Short title This Act may be cited as the Strengthening Innovation in Medicare and Medicaid Act . 2. Sense of Congress It is the sense of Congress that: (1) The Center for Medicare and Medicaid Innovation (CMI) represents a valuable tool for testing innovative health care payment and service delivery models which can improve the coordination, quality, and efficiency of health care services. (2) The model testing process is intended to test concepts on a limited scale first in Phase I, then assess initial results, and, if results merit, expand the model to a larger test in Phase II to confirm the initial results. (3) Starting model testing on a limited scale, assessing results, and then expanding the model to confirm initial results protects the integrity of the Medicare program by minimizing unintentional losses or negative impacts to the patients or providers participating in Phase I model testing. (4) CMI should focus its attention on models most likely to succeed and should continually assess models and terminate those which are not generating results in keeping with its purpose—lowering costs while maintaining or preserving patient outcomes. (5) Mandatory models may be necessary to test certain payment models but should be used judiciously and be as limited in scope as possible to minimize accidental adverse impacts. (6) As CMI may waive certain provisions of Medicare regulations, Congress may block models which functionally alter or change the underlying existing statutes. 3. Defining CMI model testing parameters (a) Scope and duration of models Section 1115A(a) of the Social Security Act ( 42 U.S.C. 1315a(a) ) is amended by adding at the end the following new paragraph: (6) Scope and duration of models tested beginning on or after the date of the enactment of the Strengthening Innovation In Medicare and Medicaid Act, for purposes of testing new payment and service delivery models, the Secretary shall limit testing of a Phase 1 model to— (A) a period not to exceed 5 years; and (B) to the lesser of ten percent of applicable individuals or 500,000 beneficiaries. . (b) Cap on phase 1 model testing Section 1115A(a) of the Social Security Act ( 42 U.S.C. 1315a(a) ), as amended by subsection (a), is further amended by adding at the end the following new paragraph: (7) Phase 1 model limitations During each fiscal year starting with Fiscal Year 2023, CMI shall initiate Phase 1 testing of no more than six new models each fiscal year. Additionally, CMI shall not concurrently test more than five Phase 1 models which involve mandatory, involuntary, or compulsory participation. . (c) Required waivers for hardship Section 1115A(a) of the Social Security Act ( 42 U.S.C. 1315a(a) ), as amended by subsection (a), is further amended by adding at the end the following new paragraph: (8) Hardship waivers Not later than 60 days after the enactment of the Strengthening Innovation in Medicare and Medicaid Act, the Secretary shall develop and implement a plan to allow applicable providers of services or supplies to request a waiver from any requirement of a model if the Secretary determines that such requirement would result in undue economic hardship to such provider or supplier or loss of access to such healthcare services or supplies for vulnerable populations. . (d) Monitoring impact Section 1115A(a) of the Social Security Act ( 42 U.S.C. 1315a(a) ), as amended by subsections (a) and (b), is further amended by adding at the end the following new paragraph: (9) Monitoring impact Not later than 60 days after the enactment of the Strengthening Innovation in Medicare and Medicaid Act, the Secretary shall develop and implement a plan to— (A) monitor continuously and on a real-time basis the effect of a model under subsection (b) on applicable individuals, and mitigate any adverse impact, such as inappropriate reductions in care or reduced access to care; (B) assess and track the impact of delivery and payment models on health disparities, using existing measures such as, but not limited to, the National Quality Forum Healthcare Disparities and Cultural Competency Measures; and (C) mitigate any adverse impact that the Secretary determines could affect beneficiary health. . 4. Implementation of testing and expansion of models with congressional inaction Section 1115A(d) of the Social Security Act ( 42 U.S.C. 1315a(d) ) is amended by adding at the end the following new paragraph: (4) Implementation of testing and expansion of models with congressional inaction (A) The Secretary shall transmit a proposal for the testing, expansion, or modification of a model under subsections (b) and (c), including a proposed effective date and a summary of the determinations and certification made under paragraphs (1) through (3) of subsection (c), if applicable, to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate. (B) The testing, expansion, or modification of a model proposed in a report submitted under subparagraph (A) shall be carried out by the Secretary if Congress does not, within 45 days of receiving such report, pass a joint resolution disapproving of the proposed testing or expansion in accordance with the following procedure: (i) The succeeding subparagraphs of this paragraph are enacted by Congress as an exercise of the rulemaking power of the Senate and the House of Representatives, respectively, and as such they shall be deemed a part of the rules of each House, respectively, but applicable only with the respect to the procedure to be followed in that House in the case of resolutions described in subparagraph (B). They shall supersede other rules only to the extent that they are inconsistent therewith. They are enacted with full recognition of the constitutional right of either House to change the rules (so far as relating to the procedure of that House) at any time, in the same manner and to the same extent as in the case of any ruse of that House. (ii) For the purpose of the succeeding paragraphs of this subsection, resolution means only a joint resolution, the matter after the resolving clause of which is as follows: That Congress disapproves the model expansion requested pursuant to section 1115A(c) of the Social Security Act transmitted by the Secretary on _____, and such an expansion shall not proceed. , the blank space therein being filled with the date on which the Secretary’s message proposing such expansion was delivered. (iii) Upon receipt of a report submitted to Congress under subparagraph (c)(4), each House shall provide copies of the report to the chairman and ranking member of the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate. (iv) A resolution shall be referred to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate. (v) If a committee to which has been referred a resolution has not reported it before the expiration of 10 legislative days after its introduction, it shall then (but not before) be in order to move to discharge the committee from further consideration of that resolution, or to discharge the committee from further consideration of any other resolution with respect to the proposed expansion which has been referred to the committee. The motion to discharge may be made only by a person favoring the resolution, shall be highly privileged (except that it may not be made after the committee has reported a resolution with respect to the same proposed expansion), and debate thereon shall be limited to not more than 1 hour, to be divided equally between those favoring and those opposing the resolution. An amendment to the motion is not in order, and it is not in order to move to reconsider the vote by which the motion is agreed to or disagreed to. If the motion to discharge is agreed to or disagreed to, the motion may not be renewed, nor may another motion to discharge the committee be made with respect to any other resolution with respect to the same proposed expansion. (vi) When the committee has reported, or has been discharged from further consideration of a resolution, it is at any time thereafter in order (even though a previous motion to the same effect has been disagreed to) to move to proceed to the consideration of the resolution. The motion is highly privileged and is not debatable. An amendment to the motion is not in order, and it is not in order to move to reconsider the vote by which the motion is agreed to or disagreed to. Debate on the resolution shall be limited to not more than 2 hours, which shall be divided equally between those favoring and those opposing the resolution. A motion further to limit debate is not debatable. An amendment to, or motion to recommit, the resolution is not in order, and it is not in order to move to reconsider the vote by which the resolution is agreed to or disagreed to. (vii) Motions to postpone, made with respect to the discharge from committee, or the consideration of, a resolution and motions to proceed to the consideration of other business shall be decided without debate. Appeals from the decision of the Chair relating to the application of the rules of the Senate or the House of Representatives, as the case may be, to the procedure relating to a resolution shall be decided without debate. (viii) Coordination with action by the other house If, before the passage by one House of a joint resolution of that House, that House receives from the other House a joint resolution, then the following procedures shall apply: (I) The joint resolution of the other House shall not be referred to a committee. (II) With respect to a joint resolution of the House receiving the resolution, the procedure in that House shall be the same as if no joint resolution had been received from the other House; but the vote on passage shall be on the joint resolution of the other House. (ix) If one House fails to introduce or consider a joint resolution under this section, the joint resolution of the other House shall be entitled to expedited floor procedures under this section. (x) If, following passage of the joint resolution in the Senate, the Senate then receives the companion measure from the House of Representatives, the companion measure shall not be debatable. (xi) If Congress passes a joint resolution, the period beginning on the date the President is presented with the joint resolution and ending on the date the President takes action with respect to the joint resolution shall be disregarded in computing the 45-calendar day period described in subsection (c)(4). (xii) If the President vetoes the joint resolution— (I) the period beginning on the date the President vetoes the joint resolution and ending on the date the Congress receives the veto message with respect to the joint resolution shall be disregarded in computing the 45-calendar day period described in subsection (c)(4), and (II) debate on a veto message in the Senate under this section shall be 1 hour equally divided between the majority and minority leaders or their designees. . 5. Public input Section 115A(d) of the Social Security Act ( 42 U.S.C. 1315a(d) ) is amended by Section 3, is further amended by adding at the end of the following new paragraphs: (5) Public input The Secretary shall use a process involving advance public notice and an opportunity for stakeholder input and public comments to ensure transparency and accountability regarding the establishment, testing, implementation, evaluation, and expansion of a model under section 1115A(b) and (c). Such public notice shall describe and define the standards, criteria, and processes that the Secretary will use for selecting and evaluating— (A) during initial stages of model development; (B) prior to testing under subsection (b)(1); (C) prior to modification of non-contractual models under subsection (b)(3)(B); and (D) following evaluation of a model under subsection (b)(4) and prior to rulemaking under subsection (c). Such notice shall explain the basis for the Secretary’s determination that the conditions set forth in section 115A(c) of the Social Security Act ( 42 U.S.C. 1315a(c) ) have been met. Additionally, the notice shall explain the basis for selection and the standards established by the Secretary under the regulations issued under paragraph (1), and any additional factors that will be used to test the model’s impact on quality of care, patient-centeredness, and innovation. The notice shall provide a minimum 45-day period for public comment. The Secretary shall take stakeholder comments into consideration when determining whether or how to refine the model or whether to proceed with testing under subsection (b)(1). (6) Consultation In carrying out the duties under this subsection, the CMI shall consult representatives of relevant Federal agencies, and clinical and analytical experts with expertise in medicine and health care management, specifically such experts with expertise in— (A) the health care needs of minority, rural and underserved populations; and (B) the financial needs of safety net, community-based, rural, and critical access providers, including federally qualified health centers. The CMI shall use open door forums or other mechanisms to seek external feedback from interested parties and incorporate that feedback into the development of models. . 6. Reestablishing judicial review Section 1115A(g) of the Social Security Act ( 42 U.S.C. 1315a(g) ) is amended— (1) in the matter preceding subparagraph (A) by inserting after or otherwise the following: (except as may be necessary to enforce requirements of this section or other laws or constitutional provisions intended to protect beneficiaries of affected programs) ; (2) by striking subparagraph (C); (3) in subparagraph (D), by adding at the end ; and ; (4) by redesignating subparagraph (D) as subparagraph (C); (5) in subparagraph (E), at the end, by striking ; and ; (6) by redesignating subparagraph (E) as subparagraph (D); and (7) by striking subparagraph (F). 7. Revision of reporting requirement Section 1115A(g) of the Social Security Act ( 42 U.S.C. 1315a(g) ) is amended— (1) by striking and not less than once every other year thereafter and inserting and, for years before 2020, not less than once biennially (and, for years beginning with 2020, not less than annually) thereafter ; and (2) by adding at the end the following new sentence: With respect to 2020 and each subsequent year, the Secretary shall submit each such report by not later than December 15 of such year. . 8. Addressing overlap in value-based care programs (a) In general (1) CMI Section 1115A(a)(5) of the Social Security Act ( 42 U.S.C. 1315a(a)(5) ) is amended by adding at the end the following new sentence: In establishing such limits, the Secretary shall take into account payment and service delivery models in progress in such geographic areas. . (2) Repeal of medicare duplication prohibition Section 1899(b) of the Social Security Act ( 42 U.S.C. 1395jjj(b) ) is amended by striking paragraph (4)(A). (b) Report Not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct an assessment and submit to Congress a report on alternative payment model overlap under the Medicare program under title XVIII of the Social Security Act. Such report shall include a description of and recommendations relating to— (1) appropriate participation in multiple alternative payment models for health care providers; (2) feasibility of adequate evaluation of alternative payment models if participants are participating in multiple arrangements; and (3) obstacles created by competing incentives with respect to alternative payment models. 9. Model eligibility and quality of care (a) Clarification of model eligibility Section 1115A of the Social Security Act ( 42 U.S.C. 1315a ) is amended— (1) by striking also before improve ; and (2) in subsection (b)(2)(A), by inserting after the second sentence the following new sentence: The Secretary may also focus on models solely aimed at implementing practices to demonstrate ways to significantly improve the care, patient safety, and health outcomes of individuals receiving benefits under the applicable title in anticipation that quality of care benefits and potential direct or indirect savings will over time accrue to the Medicare or Medicaid program. . (b) Additional opportunity Section 1115A(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1315a(b)(2)(B) ) is amended by adding at the end the following new clause: (xxviii) Implementing newly recognized and evidence-based, professionally supported care delivery practices and bundles to improve the efficient and effective delivery of hospital-based care and lead to enhanced patient outcomes, reductions in readmissions, or avoidance of costly medical errors or complications. . (c) Inclusion of indirect savings Section 1115A(b)(3)(A) of the Social Security Act ( 42 U.S.C. 1315a(b)(3)(A) ) is amended by inserting at the end or that savings cannot be made indirectly over time when testing quality of care delivery models. . (d) Evaluating quality of care Section 1115A(b)(4) of the Social Security Act ( 42 U.S.C. 1315a(b)(4) ) is amended— (1) in subparagraph (A), by amending clause (i) to read as follows: (i) the quality of care furnished under the model, including the measurement of patient-level outcomes, patient-centeredness, and any unintended consequences, such as access to services, using criteria determined appropriate by the Secretary for each model; and ; and (2) in subparagraph (C), by striking and before patient-centered care and inserting , are appropriate to issues of quality outcomes related to the medical conditions under study, and are . 10. GAO report Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the efforts of the Center for Medicare and Medicaid Innovation to attract, retain, and develop emerging experts, including underrepresented individuals in medicine, such as women, racial and ethnic minorities, and other groups. Such report shall include an analysis of the role minority staff play in model development and operational decisions on an ongoing bases and of the impact of the existing authority provided to the Center for Medicare and Medicaid Innovation to address workforce shortages and gaps in priority areas. 11. Effective date Except as otherwise provided in the previous sections of this Act (or the amendments made by such sections), such amendments shall apply with respect to the testing, expansion, or modification of models on or after January 1, 2022.