Division CC — Health extenders
CC Health extenders
I Medicare Provisions
A Medicare Extenders
101. Extension of the work geographic index floor under the medicare program
Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w–4(e)(1)(E)), as amended by section 3801 of the CARES Act (Public Law 116–136), section 2201 of the Continuing Appropriations Act, 2021 and Other Extensions Act (Public Law 116–159), and section 1101 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended by striking “December 19, 2020” and inserting “January 1, 2024”.
102. Extension of funding for quality measure endorsement, input, and selection
Extension— Section 1890(d)(2) of the Social Security Act (42 U.S.C. 1395aaa(d)(2)), as amended by section 1103 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended—
in the first sentence, by striking “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” and inserting “ $26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 2022, and $20,000,000 for fiscal year 2023”; and
in the third sentence, by striking “and 2020, and for the period beginning on October 1, 2020, and ending on December 18, 2020” and inserting “2020, 2021, 2022, and 2023”.
Additional reporting requirements— Section 1890 of the Social Security Act (42 U.S.C. 1395aaa) is amended—
in subsection (e)—
by redesignating paragraphs (1) through (6) as subparagraphs (A) through (F), respectively;
by striking “Congress.—By not later than” and inserting “Congress.—
“(1) In general—By not later than”
in subparagraph (A), as redesignated by this paragraph, by striking the last sentence;
in subparagraph (D), as so redesignated, by striking “A description” and inserting “Subject to paragraph (2)(B), a description”;
in subparagraph (E), as so redesignated, by striking “The amount” and inserting “Subject to paragraph (2)(B), the amount”;
in subparagraph (F), as so redesignated, by striking “Estimates” and inserting “Subject to paragraph (2)(B), estimates”; and
by adding at the end the following new paragraph:
“(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 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) Ensuring detailed information
“(i) In general—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) 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.”
by adding at the end the following new subsection:
“(f) Additional reporting by the Secretary to Congress
“(1) In general—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) Separate report—The annual report required under paragraph (1) shall be separate from the annual report required under subsection (e).”
Input for removal of measures— Section 1890(b) of the Social Security Act (42 U.S.C. 1395aaa(b)) is amended by inserting after paragraph (3) the following new paragraph:
“(4) Removal of measures—The entity may provide input to the Secretary on quality and efficiency measures described in paragraph (7)(B) that could be considered for removal.”
Prioritization of measure endorsement— Section 1890(b) of the Social Security Act (42 U.S.C. 1395aaa(b)) is amended by adding at the end the following new paragraph:
“(9) Prioritization of measure endorsement—The Secretary—
“(A) during the period beginning on the date of the enactment of this paragraph 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.”
103. Extension of funding outreach and assistance for low-income programs
State health insurance programs— Subsection (a)(1)(B) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b–3 note), as amended by section 3306 of the Patient Protection and Affordable Care Act (Public Law 111–148), section 610 of the American Taxpayer Relief Act of 2012 (Public Law 112–240), section 1110 of the Pathway for SGR Reform Act of 2013 (Public Law 113–67), section 110 of the Protecting Access to Medicare Act of 2014 (Public Law 113–93), section 208 of the Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 114–10), section 50207 of division E of the Bipartisan Budget Act of 2018 (Public Law 115–123), section 1402 of division B of the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Public Law 116–59), section 1402 of division B of the Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 (Public Law 116–69), section 103 of division N of the Further Consolidated Appropriations Act, 2020 (Public Law 116–94), section 3803 of the CARES Act (Public Law 116–136), section 2203 of the Continuing Appropriations Act, 2021 and Other Extensions Act (Public Law 116–159), and section 1102 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended—
in clause (x), by striking at the end “and”; and
by striking clause (xi) and inserting the following clauses:
“(xi) for fiscal year 2021, $15,000,000;
“(xii) for fiscal year 2022, $15,000,000; and
“(xiii) for fiscal year 2023, $15,000,000.”
in clause (x), by striking at the end “and”; and
by striking clause (xi) and inserting the following clauses:
“(xi) for fiscal year 2021, $15,000,000;
“(xii) for fiscal year 2022, $15,000,000; and
“(xiii) for fiscal year 2023, $15,000,000.”
Aging and disability resource centers— Subsection (c)(1)(B) of such section 119, as so amended, is amended—
in clause (x), by striking at the end “and”;
by striking clause (xi) and inserting the following clauses:
“(xi) for fiscal year 2021, $5,000,000;
“(xii) for fiscal year 2022, $5,000,000; and
“(xiii) for fiscal year 2023, $5,000,000,”
Contract with the national center for benefits and outreach enrollment— Subsection (d)(2) of such section 119, as so amended, is amended—
in clause (x), by striking at the end “and”;
by striking clause (xi) and inserting the following clauses:
“(xi) for fiscal year 2021, $15,000,000;
“(xii) for fiscal year 2022, $15,000,000; and
“(xiii) for fiscal year 2023, $15,000,000.”
104. Extension of medicare patient IVIG access demonstration project
Extension of demonstration project— Section 101(b) of the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C. 13951 note) is amended—
by striking paragraph (1) and inserting the following:
“(1) Duration—Beginning not later than one year after the date of enactment of this Act, the Secretary shall conduct the demonstration project for a period of 3 years and, subject to the availability of funds under subsection (g), the period beginning on October 1, 2017, and ending on December 31, 2023.”
in paragraph (2)—
by amending the first sentence to read as follows: “The Secretary shall enroll for participation in the demonstration project for the period beginning on October 1, 2014, and ending on September 30, 2020, not more than 4,000 Medicare beneficiaries who have been diagnosed with primary immunodeficiency disease and for the period beginning on October 1, 2014, and ending on December 31, 2023, not more than 6,500 Medicare beneficiaries who have been so diagnosed.”; and
by striking “December 31, 2020” and inserting “December 31, 2023”.
by redesignating paragraph (2) as paragraph (3); and
by inserting after paragraph (1) the following new paragraph:
“(2) Updated evaluation and report—Not later than 2 years after the date of the enactment of Consolidated Appropriations Act, 2021, the Secretary shall submit to Congress an updated report that contains the following:
“(A) The total number of beneficiaries enrolled in the demonstration project during the updated report period.
“(B) The total number of claims submitted for services during the updated report period, disaggregated by month.
“(C) An analysis of the impact of the demonstration on beneficiary access to the in-home administration of intravenous immune globin, including the impact on beneficiary health.
“(D) An analysis of the impact of in-home administration of intravenous immune globin on overall costs to Medicare, including the cost differential between in-home administration of intravenous immune globin and administration of intravenous immune globin in a healthcare facility.
“(E) To the extent practicable, a survey of providers and enrolled beneficiaries that participated in the demonstration project that identifies barriers to accessing services, including reimbursement for items and services.
“(F) Recommendations to Congress on the appropriateness of establishing a permanent bundled services payment for the in-home administration of intravenous immune globin for Medicare beneficiaries.”
Definition of updated report period— Section 101(h) is amended by adding at the end the following new paragraph:
“(4) Updated report period—The term “updated report period” means the period beginning on October 1, 2014, and ending on September 30, 2020.”
105. Extending the independence at home medical practice demonstration program under the medicare program
in subsection (e)—
in paragraph (1), by striking “7-year” and inserting “10-year”; and
in paragraph (5)—
in the first sentence, by striking “15,000” and inserting “20,000”;
in the second sentence, by striking “sixth and seventh” and inserting “sixth through tenth”; and
by adding at the end the following new sentence: “An applicable beneficiary that participates in the demonstration program by reason of the increase from 15,000 to 20,000 in the first sentence of this paragraph pursuant to the amendment made by section 105 of division CC of the Consolidated Appropriations Act, 2021 shall be considered in the spending target estimates under paragraph (1) of subsection (c) and the incentive payment calculations under paragraph (2) of such subsection for the eighth through tenth years of such program.”; and
in subsection (h), by inserting “and $9,000,000 for fiscal year 2021” after “2015”.
Effective date— The amendments made by subsection (a) shall take effect as if included in the enactment of Public Law 111–148.
B Other Medicare Provisions
111. Improving measurements under the skilled nursing facility value-based purchasing program under the Medicare program
in paragraph (1), by adding at the end the following new subparagraph:
“(C) Exclusions—With respect to payments for services furnished on or after October 1, 2022, this subsection shall not apply to a facility for which there are not a minimum number (as determined by the Secretary) of—
“(i) cases for the measures that apply to the facility for the performance period for the applicable fiscal year; or
“(ii) measures that apply to the facility for the performance period for the applicable fiscal year.”
in paragraph (2)(A)—
by striking “The Secretary shall apply” and inserting
“(i) shall apply”
by striking the period at the end and inserting “; and”; and
by adding at the end the following:
“(ii) may, with respect to payments for services furnished on or after October 1, 2023, apply additional measures determined appropriate by the Secretary, which may include measures of functional status, patient safety, care coordination, or patient experience.”
in subparagraph (A) of each of paragraphs (3) and (4), by striking “measure” and inserting “measures”; and
by adding at the end the following new paragraph:
“(12) Validation
“(A) In general—The Secretary shall apply to the measures applied under this subsection and the data submitted under subsection (e)(6) a process to validate such measures and data, as appropriate, which may be similar to the process specified in section 1886(b)(3)(B)(viii)(XI) for validating inpatient hospital measures.
“(B) Funding—For purposes of carrying out this paragraph, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund established under section 1817, of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2023 through 2025, to remain available until expended.”
Report by MedPAC— Not later than March 15, 2022, the Medicare Payment Advisory Commission shall submit to Congress a report on establishing a prototype value-based payment program under a unified prospective payment system for post-acute care services under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.). Such report—
shall—
consider design elements such as—
measures that are important to the Medicare program and to beneficiaries under such program;
methodologies for scoring provider performance and effects on payment; and
other elements determined appropriate by the Commission; and
analyze the effects of implementing such prototype program; and
may—
discuss the possible effects, with respect to the Medicare program, on program spending, post-acute care providers, patient outcomes, and other effects determined appropriate by the Commission; and
include recommendations with respect to such prototype program, as determined appropriate by the Commission, to Congress and the Secretary of Health and Human Services.
112. Providing the Medicare Payment Advisory Commission and Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information
Access to certain part D payment data— Section 1860D–15(f) of the Social Security Act (42 U.S.C. 1395w–115(f)) is amended—
in paragraph (2)—
in subparagraph (A)(ii), by striking “and” at the end;
in subparagraph (B), by striking the period at the end and inserting “; and”; and
by inserting at the end the following new subparagraph:
“(C) by the Executive Director of the Medicare Payment Advisory Commission for purposes of monitoring, making recommendations for, and analysis of the program under this title and by the Executive Director of the Medicaid and CHIP Payment and Access Commission for purposes of monitoring, making recommendations for, and analysis of the Medicaid program established under title XIX and the Children’s Health Insurance Program under title XXI.”
by adding at the end the following new paragraph:
“(3) Additional restrictions on disclosure of information
“(A) In general—The Executive Directors described in paragraph (2)(C) shall not disclose any of the following information disclosed to such Executive Directors or obtained by such Executive Directors pursuant to such paragraph, with respect to a prescription drug plan offered by a PDP sponsor or an MA–PD plan offered by an MA organization:
“(i) The specific amounts or the identity of the source of any rebates, discounts, price concessions, or other forms of direct or indirect remuneration under such prescription drug plan or such MA–PD plan.
“(ii) Information submitted with the bid submitted under section 1860D–11(b) by such PDP sponsor or under section 1854(a) by such MA organization.
“(iii) In the case of such information from prescription drug event records, information in a form that would not be permitted under section 423.505(m) of title 42, Code of Federal Regulations, or any successor regulation, if released by the Centers for Medicare & Medicaid Services.
“(B) Clarification—The restrictions on disclosures described in subparagraph (A) shall also apply to disclosures to individual Commissioners of the Medicare Payment Advisory Commission or of the Medicaid and CHIP Payment and Access Commission.”
Access to certain rebate and payment data under Medicare and Medicaid— Section 1927(b)(3)(D) of the Social Security Act (42 U.S.C. 1396r–8(b)(3)(D)) is amended—
in the matter before clause (i), by striking “subsection (a)(6)(A)(ii)” and inserting “subsection (a)(6)(A)”;
in clause (v), by striking “and” at the end;
in clause (vi), by striking the period at the end and inserting “, and”;
by inserting after clause (vi) the following new clause:
“(vii) to permit the Executive Director of the Medicare Payment Advisory Commission and the Executive Director of the Medicaid and CHIP Payment and Access Commission to review the information provided.”
in the matter at the end, by striking “1860D–4(c)(2)(E)” and inserting “1860D–4(c)(2)(G)”; and
by adding at the end the following new sentences: “Any information disclosed to the Executive Director of the Medicare Payment Advisory Commission or the Executive Director of the Medicaid and CHIP Payment and Access Commission pursuant to this subparagraph shall not be disclosed by either such Executive Director in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler. Such information also shall not be disclosed by either such Executive Director to individual Commissioners of the Medicare Payment Advisory Commission or of the Medicaid and CHIP Payment and Access Commission in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler.”.
113. Moratorium on payment under the Medicare physician fee schedule of the add on code for inherently complex evaluation and management visits
In general— The Secretary of Health and Human Services may not, prior to January 1, 2024, make payment under the fee schedule under section 1848 of the Social Security Act (42 U.S.C. 1395w–4) for services described by Healthcare Common Procedure Coding System (HCPCS) code G2211 (or any successor or substantially similar code), as described in section II.F. of the final rule filed by the Secretary with the Office of the Federal Register for public inspection on December 2, 2020, and entitled “Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st , May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19”.
Implementation— Notwithstanding any other provision of law, the Secretary may implement this section by interim final rule, program instruction, or otherwise.
114. Temporary freeze of APM payment incentive thresholds
in subparagraph (B)—
in the heading, by striking “and 2022” and inserting “through 2024”; and
in the matter preceding clause (i), by striking “2021 and 2022” and inserting “each of 2021 through 2024”;
in subparagraph (C)—
in the heading, by striking “2023” and inserting “2025”; and
in the matter preceding clause (i), by striking “2023” and inserting “2025”; and
in subparagraph (D), by adding at the end the following: “With respect to 2023 and 2024, the Secretary shall use the same percentage criteria for counts of patients that are used in 2022.”.
Partial qualifying APM participant modifications— Section 1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C. 1395w–4(q)(1)(C)(iii)) is amended—
in subclause (II), in the matter preceding item (aa), by striking “2021 and 2022” and inserting “each of 2021 through 2024”; and
in subclause (III), in the matter preceding item (aa), by striking “2023” and inserting “2025”.
Effective date— The amendments made by this section shall take effect on the date of the enactment of this Act.
115. Permitting occupational therapists to conduct the initial assessment visit and complete the comprehensive assessment with respect to certain rehabilitation services for home health agencies under the Medicare program
Not later than January 1, 2022, the Secretary of Health and Human Services shall revise subsections (a)(2) and (b)(3) of section 484.55 of title 42, Code of Federal Regulations, or a successor regulation, to permit an occupational therapist to conduct the initial assessment visit and to complete the comprehensive assessment (as such terms are described in such subsections, respectively) for home health services for an individual under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) if the home health plan of care for such individual—
does not initially include skilled nursing care;
includes occupational therapy; and
includes physical therapy or speech language pathology.
116. Centers for Medicare & Medicaid Services provider outreach and reporting on cognitive assessment and care plan services
Outreach— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to Medicare payment for cognitive assessment and care plan services furnished to individuals with cognitive impairment such as Alzheimer's disease and related dementias, identified as of January 1, 2018, by HCPCS code 99483, or any successor to such code (in this section referred to as “cognitive assessment and care plan services”). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the addition of such services as a covered benefit under the Medicare program, including the requirements for eligibility for such services.
Reports—
HHS report on provider outreach— Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under subsection (a). Such report shall include a description of the methods used for such outreach.
GAO report on utilization rates— Not later than 3 years after such date of enactment, the Comptroller General of the United States shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who were furnished cognitive assessment and care plan services for which payment was made under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.). Such report shall include information on barriers Medicare beneficiaries face to access such services, and recommendations for such legislative and administrative action as the Comptroller General deems appropriate.
117. Continued coverage of certain temporary transitional home infusion therapy services
In general— Section 1861(iii)(3)(C) of the Social Security Act (42 U.S.C. 1395x(iii)(3)(C)) is amended by inserting after clause (ii) the following flush sentence:
Effective date— The amendment made by subsection (a) shall apply to items and services furnished on or after January 1, 2021.
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendment made by subsection (a) by interim final rule, program instruction, or otherwise.
118. Transitional coverage and retroactive Medicare part D coverage for certain low-income beneficiaries
by redesignating subsection (e) as subsection (f); and
by adding after subsection (d) the following new subsection:
“(e) Limited income newly eligible transition program
“(1) In general—Beginning not later than January 1, 2024, the Secretary shall carry out a program to provide transitional coverage for covered part D drugs for LI NET eligible individuals in accordance with this subsection.
“(2) LI net eligible individual defined—For purposes of this subsection, the term LI NET eligible individual means a part D eligible individual who—
“(A) meets the requirements of clauses (ii) and (iii) of subsection (a)(3)(A); and
“(B) has not yet enrolled in a prescription drug plan or an MA–PD plan, or, who has so enrolled, but with respect to whom coverage under such plan has not yet taken effect.
“(3) Transitional coverage—For purposes of this subsection, the term transitional coverage means with respect to an LI NET eligible individual—
“(A) immediate access to covered part D drugs at the point of sale during the period that begins on the first day of the month such individual is determined to meet the requirements of clauses (ii) and (iii) of subsection (a)(3)(A) and ends on the date that coverage under a prescription drug plan or MA–PD plan takes effect with respect to such individual; and
“(B) in the case of an LI NET eligible individual who is a full-benefit dual eligible individual (as defined in section 1935(c)(6)) or a recipient of supplemental security income benefits under title XVI, retroactive coverage (in the form of reimbursement of the amounts that would have been paid under this part had such individual been enrolled in a prescription drug plan or MA–PD plan) of covered part D drugs purchased by such individual during the period that begins on the date that is the later of—
“(i) the date that such individual was first eligible for a low-income subsidy under this part; or
“(ii) the date that is 36 months prior to the date such individual enrolls in a prescription drug plan or MA–PD plan,
“(4) Program administration
“(A) Point of contact—The Secretary shall, as determined appropriate by the Secretary, administer the program under this subsection through a contract with a single program administrator.
“(B) Benefit design—The Secretary shall ensure that the transitional coverage provided to LI NET eligible individuals under this subsection—
“(i) provides access to all covered part D drugs under an open formulary;
“(ii) permits all pharmacies determined by the Secretary to be in good standing to process claims under the program;
“(iii) is consistent with such requirements as the Secretary considers necessary to improve patient safety and ensure appropriate dispensing of medication; and
“(iv) meets such other requirements as the Secretary may establish.
“(5) Relationship to other provisions of this title; waiver authority
“(A) In general—The following provisions shall not apply with respect to the program under this subsection:
“(i) Paragraphs (1) and (3)(B) of section 1860D–4(a) (relating to dissemination of general information; availability of information on changes in formulary through the internet).
“(ii) Subparagraphs (A) and (B) of section 1860D–4(b)(3) (relating to requirements on development and application of formularies; formulary development).
“(iii) Paragraphs (1)(C) and (2) of section 1860D–4(c) (relating to medication therapy management program).
“(B) Waiver authority—The Secretary may waive such other requirements of title XI and this title as may be necessary to carry out the purposes of the program established under this subsection.
“(6) Contracting authority—The authority vested in the Secretary by this subsection may be performed without regard to such provisions of law or regulations relating to the making, performance, amendment, or modification of contracts of the United States as the Secretary may determine to be inconsistent with the furtherance of the purpose of this title.”
119. Increasing the use of real-time benefit tools to lower beneficiary costs
Requiring prescription drug plan sponsors and Medicare Advantage organizations To include real-Time benefit information under Medicare part D— Section 1860D–4 of the Social Security Act (42 U.S.C. 1395w–104) is amended—
by redesignating subsection (m) (relating to program integrity transparency measures), as added by section 6063(c) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (Public Law 115–271), as subsection (n); and
by adding at the end the following new subsection:
“(o) Real-Time benefit information
“(1) In general—After the Secretary has adopted a standard under paragraph (3) for electronic real-time benefit tools, and at a time determined appropriate by the Secretary, a PDP sponsor of a prescription drug plan shall implement one or more of such tools that meet the requirements described in paragraph (2).
“(2) Requirements—For purposes of paragraph (1), the requirements described in this paragraph, with respect to an electronic real-time benefit tool, are that the tool is capable of—
“(A) integrating with electronic prescribing and electronic health record systems of prescribing health care professionals for the transmission of formulary and benefit information in real time to such professionals; and
“(B) with respect to a covered part D drug, transmitting such information specific to an individual enrolled in a prescription drug plan, including the following:
“(i) A list of any clinically-appropriate alternatives to such drug included in the formulary of such plan.
“(ii) Cost-sharing information and the negotiated price for such drug and such alternatives at multiple pharmacy options, including the individual’s preferred pharmacy and, as applicable, other retail pharmacies and a mail order pharmacy.
“(iii) The formulary status of such drug and such alternatives and any prior authorization or other utilization management requirements applicable to such drug and such alternatives included in the formulary of such plan.
“(3) Standards—In order to be treated (for purposes of this subsection) as an electronic real-time benefit tool described in paragraph (1), such tool shall comply with technical standards adopted by the Secretary in consultation with the National Coordinator for Health Information Technology through notice and comment rulemaking. Such technical standards adopted by the Secretary shall be developed by a standards development organization, such as the National Council for Prescription Drug Programs, that consults with stakeholders such as PDP sponsors, Medicare Advantage organizations, beneficiary advocates, health care professionals, and health information technology software vendors.
“(4) Rules of construction—Nothing in this subsection shall be construed—
“(A) to prohibit the application of paragraph (b)(7) of section 423.160 of title 42, Code of Federal Regulations, as is to be added to such section pursuant to the final rule published in the Federal Register on May 23, 2019, and titled “Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses” (84 Fed. Reg. 23832 through 23884); or
“(B) to allow a PDP sponsor to use a real-time benefit tool to steer an individual, without the consent of the individual, to a particular pharmacy or pharmacy type over their preferred pharmacy or pharmacy type nor prohibit the designation of an individual’s preferred pharmacy under such tool.”
Requiring qualified electronic health records To include real-Time benefit tools— Section 3000(13) of the Public Health Service Act (42 U.S.C. 300jj(13)) is amended—
in subparagraph (A), by striking “and” at the end;
in subparagraph (B), by striking the period and inserting “; and”; and
by adding at the end the following:
“(C) includes, or is capable of including, a real-time benefit tool that conveys patient-specific real-time cost and coverage information with respect to prescription drugs that, with respect to any health information technology certified for electronic prescribing, the technology shall be capable of incorporating the information described in clauses (i) through (iii) of paragraph (2)(B) of section 1860D–4(o) of the Social Security Act at a time specified by the Secretary but not before the Secretary adopts a standard for such tools as described in paragraph (1) of such section.”
Inclusion of use of real-Time electronic information in shared decision-Making under MIPS— Section 1848(q)(2)(B)(iii)(IV) of the Social Security Act (42 U.S.C. 1395w–4(q)(2)(B)(iii)(IV)) is amended by adding at the end the following new sentences: “This subcategory shall include as an activity, for performance periods beginning on or after January 1, 2022, use of a real-time benefit tool as described in section 1860D–4(o). The Secretary may establish this activity as a standalone or as a component of another activity.”.
120. Beneficiary enrollment simplification
Beneficiary enrollment simplification—
Effective date of coverage— Section 1838(a) of the Social Security Act (42 U.S.C. 1395q(a)) is amended—
by amending paragraph (2) to read as follows:
“(2)
“(A) in the case of an individual who enrolls pursuant to subsection (d) of section 1837 before the month in which he first satisfies paragraph (1) or (2) of section 1836(a), the first day of such month,
“(B) in the case of an individual who first satisfies such paragraph in a month beginning before January 2023 and who enrolls pursuant to such subsection (d)—
“(i) in such month in which he first satisfies such paragraph, the first day of the month following the month in which he so enrolls,
“(ii) in the month following such month in which he first satisfies such paragraph, the first day of the second month following the month in which he so enrolls, or
“(iii) more than one month following such month in which he satisfies such paragraph, the first day of the third month following the month in which he so enrolls,
“(C) in the case of an individual who first satisfies such paragraph in a month beginning on or after January 1, 2023, and who enrolls pursuant to such subsection (d) in such month in which he first satisfies such paragraph or in any subsequent month of his initial enrollment period, the first day of the month following the month in which he so enrolls, or
“(D) in the case of an individual who enrolls pursuant to subsection (e) of section 1837 in a month beginning—
“(i) before January 1, 2023, the July 1 following the month in which he so enrolls; or
“(ii) on or after January 1, 2023, the first day of the month following the month in which he so enrolls; or”
by amending paragraph (3) to read as follows:
“(3) in the case of an individual who is deemed to have enrolled—
“(A) on or before the last day of the third month of his initial enrollment period, the first day of the month in which he first meets the applicable requirements of section 1836(a) or July 1, 1973, whichever is later, or
“(B) on or after the first day of the fourth month of his initial enrollment period, and where such month begins—
“(i) before January 1, 2023, as prescribed under subparagraphs (B)(i), (B)(ii), (B)(iii), and (D)(i) of paragraph (2), or
“(ii) on or after January 1, 2023, as prescribed under subparagraphs (C) and (D)(ii) of paragraph (2).”
Special enrollment periods for exceptional circumstances—
Enrollment— Section 1837 of the Social Security Act (42 U.S.C. 1395p) is amended by adding at the end the following new subsection:
“(m) Beginning January 1, 2023, the Secretary may establish special enrollment periods in the case of individuals who satisfy paragraph (1) or (2) of section 1836(a) and meet such exceptional conditions as the Secretary may provide.”
Coverage period— Section 1838 of the Social Security Act (42 U.S.C. 1395q) is amended by adding at the end the following new subsection:
“(g) Notwithstanding subsection (a), in the case of an individual who enrolls during a special enrollment period pursuant to section 1837(m), the coverage period shall begin on a date the Secretary provides in a manner consistent (to the extent practicable) with protecting continuity of health benefit coverage.”
in section 1818A(c)(3), by striking “subsections (h) and (i) of section 1837” and inserting “subsections (h), (i), and (m) of section 1837”; and
in section 1839(b), in the first sentence, by striking “or (l)” and inserting “, (l), or (m)”.
Technical correction— Section 1839(b) of the Social Security Act (42 U.S.C. 1395r(b)) is amended by adding at the end the following new sentence: “For purposes of determining any increase under this subsection for individuals whose enrollment occurs on or after January 1, 2023, the second sentence of this subsection shall be applied by substituting “close of the month” for “close of the enrollment period” each place it appears.”.
Report— Not later than January 1, 2023, the Secretary of Health and Human Services shall submit to the Committee on Ways and Means and Committee on Energy and Commerce of the House of Representatives and the Committee on Finance and Special Committee on Aging of the Senate a report on how to align existing Medicare enrollment periods under title XVIII of the Social Security Act, including the general enrollment period under part B of such title and the annual, coordinated election period under the Medicare Advantage program under part C of such title and under the prescription drug program under part D of such title. Such report shall include recommendations consistent with the goals of maximizing coverage continuity and choice and easing beneficiary transition.
Funding— Section 1808 of the Social Security Act (42 U.S.C. 1395b–9) is amended by adding the end the following new subsection:
“(e) Funding for implementation of beneficiary enrollment simplification—For purposes of carrying out the provisions of and the amendments made by section 120 of division CC of the Consolidated Appropriations Act, 2021, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 and the Federal Supplementary Medical Insurance Trust Fund under section 1841 (in such proportion as the Secretary determines appropriate), to the Centers for Medicare & Medicaid Services Program Management Account, of $2,000,000 for each of fiscal years 2021 through 2030, to remain available until expended.”
121. Waiving budget neutrality for oxygen under the Medicare program
In general— Section 1834(a)(9)(D)(ii) of the Social Security Act (42 U.S.C. 1395m(a)(9)(D)(ii)), with application of subsection (b), is amended by adding at the end the following new sentence: “The requirement of the preceding sentence shall not apply beginning with the second calendar quarter beginning on or after the date of the enactment of this sentence.”.
Technical correction—
In general— Section 4552(b) of the Balanced Budget Act of 1997 (Public Law 105–33) is amended by striking “section 1848(a)(9)” and inserting “section 1834(a)(9)”.
Effective date— The amendment made by paragraph (1) shall take effect as if included in the enactment of the Balanced Budget Act of 1997 (Public Law 105–33).
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
122. Waiving medicare coinsurance for certain colorectal cancer screening tests
in the second sentence, by striking “section 1834(0)” and inserting “section 1834(o)”;
by moving such second sentence 2 ems to the left; and
by inserting the following third sentence following such second sentence: “For services furnished on or after January 1, 2022, paragraph (1)(Y) shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.”.
Special coinsurance rule for certain tests— Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—
in subsection (a)(1)(Y), by inserting “subject to subsection (dd),” before “with respect to”; and
by adding at the end the following new subsection:
“(dd) Special coinsurance rule for certain colorectal cancer screening tests
“(1) In general—In the case of a colorectal cancer screening test to which paragraph (1)(Y) of subsection (a) would not apply but for the third sentence of such subsection that is furnished during a year beginning on or after January 1, 2022, and before January 1, 2030, the amount paid shall be equal to the specified percent (as defined in paragraph (2)) for such year of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such test under this part (or, in the case such test is a covered OPD service (as defined in subsection (t)(1)(B)), the amount determined under subsection (t)).
“(2) Specified percent defined—For purposes of paragraph (1), the term “specified percent” means—
“(A) for 2022, 80 percent;
“(B) for 2023 through 2026, 85 percent; and
“(C) for 2027 through 2029, 90 percent.”
Conforming amendments— Paragraphs (2) and (3) of section 1834(d) of the Social Security Act (42 U.S.C. 1395m(d)) are each amended—
in subparagraph (C)(ii), in the matter preceding subclause (I), by striking “Notwithstanding” and inserting “Subject to section 1833(a)(1)(Y), but notwithstanding”; and
in subparagraph (D), by striking “If during” and inserting “Subject to section 1833(a)(1)(Y), if during”.
123. Expanding access to mental health services furnished through telehealth
Treatment of mental health services furnished through telehealth— Paragraph (7) of section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
by striking “disorder services furnished through telehealth.—The geographic” and inserting “disorder services and mental health services furnished through telehealth.—
“(A) In general—The geographic”
in subparagraph (A), as added by paragraph (1), by inserting “or, on or after the first day after the end of the emergency period described in section 1135(g)(1)(B), subject to subparagraph (B), to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder, as determined by the Secretary,” after “as determined by the Secretary,”; and
by adding at the end the following new subparagraph:
“(B) Requirements for mental health services furnished through telehealth
“(i) In general—Payment may not be made under this paragraph for telehealth services furnished by a physician or practitioner to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder unless such physician or practitioner furnishes an item or service in person, without the use of telehealth, for which payment is made under this title (or would have been made under this title if such individual were entitled to, or enrolled for, benefits under this title at the time such item or service is furnished)—
“(I) within the 6-month period prior to the first time such physician or practitioner furnishes such a telehealth service to the eligible telehealth individual; and
“(II) during subsequent periods in which such physician or practitioner furnishes such telehealth services to the eligible telehealth individual, at such times as the Secretary determines appropriate.
“(ii) Clarification—This subparagraph shall not apply if payment would otherwise be allowed—
“(I) under this paragraph (with respect to telehealth services furnished to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder); or
“(II) under this subsection without application of this paragraph.”
Implementation— Notwithstanding any other provision of law, the Secretary may implement the provisions of, or amendments made by, this section by interim final rule, program instruction, or otherwise.
124. Public-private partnership for health care waste, fraud, and abuse detection
In general— Section 1128C(a) of the Social Security Act (42 U.S.C. 1320a–7c(a)) is amended by adding at the end the following new paragraph:
“(6) Public-private partnership for waste, fraud, and abuse detection
“(A) In general—Under the program described in paragraph (1), there is established a public-private partnership (in this paragraph referred to as the “partnership”) of health plans, Federal and State agencies, law enforcement agencies, health care anti-fraud organizations, and any other entity determined appropriate by the Secretary (in this paragraph referred to as “partners”) for purposes of detecting and preventing health care waste, fraud, and abuse.
“(B) Contract with trusted third party—In carrying out the partnership, the Secretary shall enter into a contract with a trusted third party for purposes of carrying out the duties of the partnership described in subparagraph (C).
“(C) Duties of partnership—The partnership shall—
“(i) provide technical and operational support to facilitate data sharing between partners in the partnership;
“(ii) analyze data so shared to identify fraudulent and aberrant billing patterns;
“(iii) conduct aggregate analyses of health care data so shared across Federal, State, and private health plans for purposes of detecting fraud, waste, and abuse schemes;
“(iv) identify outlier trends and potential vulnerabilities of partners in the partnership with respect to such schemes;
“(v) refer specific cases of potential unlawful conduct to appropriate governmental entities;
“(vi) convene, not less than annually, meetings with partners in the partnership for purposes of providing updates on the partnership’s work and facilitating information sharing between the partners;
“(vii) enter into data sharing and data use agreements with partners in the partnership in such a manner so as to ensure the partnership has access to data necessary to identify waste, fraud, and abuse while maintaining the confidentiality and integrity of such data;
“(viii) provide partners in the partnership with plan-specific, confidential feedback on any aberrant billing patterns or potential fraud identified by the partnership with respect to such partner;
“(ix) establish a process by which entities described in subparagraph (A) may enter the partnership and requirements such entities must meet to enter the partnership;
“(x) provide appropriate training, outreach, and education to partners based on the results of data analyses described in clauses (ii) and (iii); and
“(xi) perform such other duties as the Secretary determines appropriate.
“(D) Substance use disorder treatment analysis—Not later than 2 years after the date of the enactment of the Consolidated Appropriations Act, 2021, the trusted third party with a contract in effect under subparagraph (B) shall perform an analysis of aberrant or fraudulent billing patterns and trends with respect to providers and suppliers of substance use disorder treatments from data shared with the partnership.
“(E) Executive Board
“(i) Executive Board composition
“(I) In general—There shall be an executive board of the partnership comprised of representatives of the Federal Government and representatives of the private sector selected by the Secretary.
“(II) Chairs—The executive board shall be co-chaired by one Federal Government official and one representative from the private sector.
“(ii) Meetings—The executive board of the partnership shall meet at least once per year.
“(iii) Executive board duties—The duties of the executive board shall include the following:
“(I) Providing strategic direction for the partnership, including membership criteria and a mission statement.
“(II) Communicating with the leadership of the Department of Health and Human Services and the Department of Justice and the various private health sector associations.
“(F) Reports—Not later than January 1, 2023, and every 2 years thereafter, the Secretary shall submit to Congress and make available on the public website of the Centers for Medicare & Medicaid Services a report containing—
“(i) a review of activities conducted by the partnership over the 2-year period ending on the date of the submission of such report, including any progress to any objectives established by the partnership;
“(ii) any savings voluntarily reported by health plans participating in the partnership attributable to the partnership during such period;
“(iii) any savings to the Federal Government attributable to the partnership during such period;
“(iv) any other outcomes attributable to the partnership, as determined by the Secretary, during such period; and
“(v) a strategic plan for the 2-year period beginning on the day after the date of the submission of such report, including a description of any emerging fraud and abuse schemes, trends, or practices that the partnership intends to study during such period.
“(G) Funding—The partnership shall be funded by amounts otherwise made available to the Secretary for carrying out the program described in paragraph (1).
“(H) Transitional provisions—To the extent consistent with this subsection, all functions, personnel, assets, liabilities, and administrative actions applicable on the date before the date of the enactment of this paragraph to the National Fraud Prevention Partnership established on September 17, 2012, by charter of the Secretary shall be transferred to the partnership established under subparagraph (A) as of the date of the enactment of this paragraph.
“(I) Nonapplicability of FACA—The provisions of the Federal Advisory Committee Act shall not apply to the partnership established by subparagraph (A).
“(J) Implementation—Notwithstanding any other provision of law, the Secretary may implement the partnership established by subparagraph (A) by program instruction or otherwise.
“(K) Definition—For purposes of this paragraph, the term “trusted third party” means an entity that—
“(i) demonstrates the capability to carry out the duties of the partnership described in subparagraph (C);
“(ii) complies with such conflict of interest standards determined appropriate by the Secretary; and
“(iii) meets such other requirements as the Secretary may prescribe.”
Potential expansion of public-Private partnership analyses— Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on the feasibility of the partnership (as described in section 1128C(a)(6) of the Social Security Act, as added by subsection (a)) establishing a system to conduct real-time data analysis to proactively identify ongoing as well as emergent fraud trends for the entities participating in the partnership and provide such entities with real-time feedback on potentially fraudulent claims. Such report shall include the estimated cost of and any potential barriers to the partnership establishing such a system.
125. Medicare payment for rural emergency hospital services
In general—
in subsection (e), in the last sentence of the matter following paragraph (9), by inserting “or a rural emergency hospital (as defined in subsection (kkk)(2))” before the period at the end; and
by adding at the end the following subsection:
“(kkk) Rural Emergency Hospital Services; Rural emergency hospital
“(1) Rural emergency hospital services
“(A) In general—The term “rural emergency hospital services ” means the following services furnished by a rural emergency hospital (as defined in paragraph (2)) that do not exceed an annual per patient average of 24 hours in such rural emergency hospital:
“(i) Emergency department services and observation care.
“(ii) At the election of the rural emergency hospital, with respect to services furnished on an outpatient basis, other medical and health services as specified by the Secretary through rulemaking.
“(B) Staffed emergency department—For purposes of subparagraph (A)(i), an emergency department of a rural emergency hospital shall be considered a staffed emergency department if it meets the following requirements:
“(i) The emergency department is staffed 24 hours a day, 7 days a week.
“(ii) A physician (as defined in section 1861(r)(1)), nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)) is available to furnish rural emergency hospital services in the facility 24 hours a day.
“(iii) Applicable staffing and staffing responsibilities under section 485.631 of title 42, Code of Federal Regulations (or any successor regulation).
“(2) Rural emergency hospital—The term “rural emergency hospital” means a facility described in paragraph (3) that—
“(A) is enrolled under section 1866(j), submits the additional information described in paragraph (4)(A) for purposes of such enrollment, and makes the detailed transition plan described in clause (i) of such paragraph available to the public, in a form and manner determined appropriate by the Secretary;
“(B) does not provide any acute care inpatient services, other than those described in paragraph (6)(A);
“(C) has in effect a transfer agreement with a level I or level II trauma center;
“(D) meets—
“(i) licensure requirements as described in paragraph (5);
“(ii) the requirements of a staffed emergency department as described in paragraph (1)(B);
“(iii) such staff training and certification requirements as the Secretary may require;
“(iv) conditions of participation applicable to—
“(I) critical access hospitals, with respect to emergency services under section 485.618 of title 42, Code of Federal Regulations (or any successor regulation); and
“(II) hospital emergency departments under this title, as determined applicable by the Secretary;
“(v) such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished rural emergency hospital services; and
“(vi) in the case where the rural emergency hospital includes a distinct part unit of the facility that is licensed as a skilled nursing facility, such distinct part meets the requirements applicable to skilled nursing facilities under this title.
“(3) Facility described—A facility described in this paragraph is a facility that as of the date of the enactment of this subsection—
“(A) was a critical access hospital; or
“(B) was a subsection (d) hospital (as defined in section 1886(d)(1)(B)) with not more than 50 beds located in a county (or equivalent unit of local government) in a rural area (as defined in section 1886(d)(2)(D)), or was a subsection (d) hospital (as so defined) with not more than 50 beds that was treated as being located in a rural area pursuant to section 1886(d)(8)(E).
“(4) Additional information
“(A) Information—For purposes of paragraph (2)(A), a facility that submits an application for enrollment under section 1866(j) as a rural emergency hospital shall submit the following information at such time and in such form as the Secretary may require:
“(i) An action plan for initiating rural emergency hospital services (as defined in paragraph (1)), including a detailed transition plan that lists the specific services that the facility will—
“(I) retain;
“(II) modify
“(III) add; and
“(IV) discontinue.
“(ii) A description of services that the facility intends to furnish on an outpatient basis pursuant to paragraph (1)(A)(ii).
“(iii) Information regarding how the facility intends to use the additional facility payment provided under section 1834(x)(2), including a description of the services covered under this title that the additional facility payment would be supporting, such as furnishing telehealth services and ambulance services, including operating the facility and maintaining the emergency department to provide such services covered under this title.
“(iv) Such other information as the Secretary determines appropriate.
“(B) Effect of enrollment—Such enrollment shall remain effective with respect to a facility until such time as—
“(i) the facility elects to convert back to its prior designation as a critical access hospital or a subsection (d) hospital (as defined in section 1886(d)(1)(B)), subject to requirements applicable under this title for such designation and in accordance with procedures established by the Secretary; or
“(ii) the Secretary determines the facility does not meet the requirements applicable to a rural emergency hospital under this subsection.
“(5) Licensure—A facility may not operate as a rural emergency hospital in a State unless the facility—
“(A) is located in a State that provides for the licensing of such hospitals under State or applicable local law; and
“(B)
“(i) is licensed pursuant to such law; or
“(ii) is approved by the agency of such State or locality responsible for licensing hospitals, as meeting the standards established for such licensing.
“(6) Discretionary authority—A rural emergency hospital may—
“(A) include a unit of the facility that is a distinct part licensed as a skilled nursing facility to furnish post-hospital extended care services; and
“(B) be considered a hospital with less than 50 beds for purposes of the exception to the payment limit for rural health clinics under section 1833(f).
“(7) Quality measurement
“(A) In general—The Secretary shall establish quality measurement reporting requirements for rural emergency hospitals, which may include the use of a small number of claims-based outcomes measures or surveys of patients with respect to their experience in the rural emergency hospital, in accordance with the succeeding provisions of this paragraph.
“(B) Quality reporting by rural emergency hospitals
“(i) In general—With respect to each year beginning with 2023, (or each year beginning on or after the date that is one year after one or more measures are first specified under subparagraph (C)), a rural emergency hospital shall submit data to the Secretary in accordance with clause (ii).
“(ii) Submission of quality data—With respect to each such year, a rural emergency hospital shall submit to the Secretary data on quality measures specified under subparagraph (C). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
“(C) Quality measures
“(i) In general—Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under section 1890(a).
“(ii) Exception—In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a), the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary.
“(iii) Consideration of low case volume when specifying performance measures—The Secretary shall, in the selection of measures specified under this subparagraph, take into consideration ways to account for rural emergency hospitals that lack sufficient case volume to ensure that the performance rates for such measures are reliable.
“(D) Public availability of data submitted—The Secretary shall establish procedures for making data submitted under subparagraph (B) available to the public regarding the performance of individual rural emergency hospitals. Such procedures shall ensure that a rural emergency hospital has the opportunity to review, and submit corrections for, the data that is to be made public with respect to the rural emergency hospital prior to such data being made public. Such information shall be posted on the Internet website of the Centers for Medicare & Medicaid Services in an easily understandable format as determined appropriate by the Secretary.
“(8) Clarification regarding application of provisions relating to off-campus outpatient department of a provider—Nothing in this subsection, section 1833(a)(10), or section 1834(x) shall affect the application of paragraph (1)(B)(v) of section 1833(t), relating to applicable items and services (as defined in subparagraph (A) of paragraph (21) of such section) that are furnished by an off-campus outpatient department of a provider (as defined in subparagraph (B) of such paragraph).
“(9) Implementation—There shall be no administrative or judicial review under section 1869, 1878, or otherwise of the following:
“(A) The determination of whether a rural emergency hospital meets the requirements of this subsection.
“(B) The establishment of requirements under this subsection by the Secretary, including requirements described in paragraphs (2)(D), (4), and (7).
“(C) The determination of payment amounts under section 1834(x), including the additional facility payment described in paragraph (2) of such section.”
Payment for rural emergency hospital services—
in paragraph (8), by striking “and” at the end;
in paragraph (9), by striking the period at the end and inserting “; and”; and
by inserting after paragraph (9) the following new paragraph:
“(10) with respect to rural emergency hospital services furnished on or after January 1, 2023, the amounts determined under section 1834(x).”
Payment amount— Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following subsection:
“(x) Payment rules relating to rural emergency hospitals
“(1) Payment for rural emergency hospital services—In the case of rural emergency hospital services (as defined in section 1861(kkk)(1)), furnished by a rural emergency hospital (as defined in section 1861(kkk)(2)) on or after January 1, 2023, the amount of payment for such services shall be equal to the amount of payment that would otherwise apply under section 1833(t) for covered OPD services (as defined in section 1833(t)(1)(B) (other than clause (ii) of such section)), increased by 5 percent to reflect the higher costs incurred by such hospitals, and shall include the application of any copayment amount determined under section 1833(t)(8) as if such increase had not occurred.
“(2) Additional facility payment
“(A) In general—The Secretary shall make monthly payments to a rural emergency hospital in an amount that is equal to 1/12 of the annual additional facility payment specified in subparagraph (B).
“(B) Annual additional facility payment amount—The annual additional facility payment amount specified in this subparagraph is—
“(i) for 2023, a Medicare subsidy amount determined under subparagraph (C); and
“(ii) for 2024 and each subsequent year, the amount determined under this subparagraph for the preceding year, increased by the hospital market basket percentage increase.
“(C) Determination of Medicare subsidy amount—For purposes of subparagraph (B)(i), the Medicare subsidy amount determined under this subparagraph is an amount equal to—
“(i) the excess (if any) of—
“(I) the total amount that the Secretary determines was paid under this title to all critical access hospitals in 2019; over
“(II) the estimated total amount that the Secretary determines would have been paid under this title to such hospitals in 2019 if payment were made for inpatient hospital, outpatient hospital, and skilled nursing facility services under the applicable prospective payment systems for such services during such year; divided by
“(ii) the total number of such hospitals in 2019.
“(D) Reporting on use of the additional facility payment—A rural emergency hospital receiving the additional facility payment under this paragraph shall maintain detailed information as specified by the Secretary as to how the facility has used the additional facility payments. Such information shall be made available to the Secretary upon request.
“(3) Payment for ambulance services—For provisions relating to payment for ambulance services furnished by an entity owned and operated by a rural emergency hospital, see section 1834(l).
“(4) Payment for post-hospital extended care services—For provisions relating to payment for post-hospital extended care services furnished by a rural emergency hospital that has a unit that is a distinct part licensed as a skilled nursing facility, see section 1888(e).
“(5) Source of payments
“(A) In general—Except as provided in subparagraph (B), payments under this subsection shall be made from the Federal Supplementary Medical Insurance Trust Fund under section 1841.
“(B) Additional facility payment and post-hospital extended care services—Payments under paragraph (2) shall be made from the Federal Hospital Insurance Trust Fund under section 1817.”
Provider agreements—
in paragraph (1)(F)(ii), by inserting “rural emergency hospitals,” after “critical access hospitals,”; and
in paragraph (3)—
in subparagraph (A), by inserting “rural emergency hospital,” after “critical access hospital,”;
in subparagraph (B), by inserting “rural emergency hospital,” after “critical access hospital,” each place it appears; and
in subparagraph (C)(ii)(II), by inserting “rural emergency hospitals,” after “critical access hospitals,” each place it appears.
Emergency medical treatment and labor act—
Section 1866(a)(1) of the Social Security Act (42 U.S.C. 1395cc(a)(1)) is amended—
in subparagraph (I)—
in the matter preceding clause (i), by striking “or critical access hospital” and inserting “, critical access hospital, or rural emergency hospital”; and
in clause (ii), by inserting “, critical access hospital, or rural emergency hospital” after “hospital”; and
in subparagraph (N)—
in the matter preceding clause (i), by striking “and critical access hospitals” and inserting “, critical access hospitals, and rural emergency hospitals”;
in clause (i), by striking “or critical access hospital” and inserting “, critical access hospital, or rural emergency hospital”; and
in clause (iv), by inserting “, critical access hospital, or rural emergency hospital” after “hospital”.
Section 1867(e)(5) of such Act (42 U.S.C. 1395dd(e)(5)) is amended by inserting “and a rural emergency hospital (as defined in section 1861(kkk)(2))” before the period.
Treatment as telehealth originating site— Section 1834(m)(4)(C)(ii) of the Social Security Act (42 U.S.C. 1395m(m)(4)(C)(ii)) is amended by adding at the end the following new subclause:
“(XI) A rural emergency hospital (as defined in section 1861(kkk)(2)).”
Conforming amendments—
Section 1861(u) of the Social Security Act (42 U.S.C. 1395x(u)) is amended by inserting “rural emergency hospital,” after “critical access hospital,”.
Section 1864 of the Social Security Act (42 U.S.C. 1395aa) is amended by inserting before the period at the end of the first sentence “, or whether a facility is a rural emergency hospital as defined in section 1861(kkk)(2).
Studies and reports—
Studies— The Secretary of Health and Human Services shall conduct 3 studies to evaluate the impact of rural emergency hospitals on the availability of health care and health outcomes in rural areas (as defined in section 1886(d)(2)(D) of the Social Security Act (42 U.S.C. 1395ww(d)(2)(D))). The Secretary shall conduct a study—
4 years after the date of the enactment of this Act;
7 years after the date of the enactment of this Act; and
10 years after the date of the enactment of this Act.
Reports— Not later than 6 months after each date that the Secretary of Health and Human Services is required to conduct a study under paragraph (1), the Secretary shall submit to Congress a report containing the results of each such study.
Funding— For purposes of carrying out this subsection, the Secretary of Health and Human Services shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 of the Social Security Act (42 U.S.C. 1395i) and the Federal Supplementary Medical Insurance Trust Fund under section 1841 of such Act (42 U.S.C. 1395t), in such proportion as the Secretary determines appropriate, to the Centers for Medicare & Medicaid Services Program Management Account, of $9,000,000. Amounts transferred under the preceding sentence shall remain available until expended.
MedPAC review of payments to rural emergency hospitals— Each report submitted by the Medicare Payment Advisory Commission under section 1805(b)(1)(C) of the Social Security Act (42 U.S.C. 1395b–6(b)(1)(C)) (beginning with 2024), shall include a review of payments to rural emergency hospitals under section 1834(x), as added by subsection (a).
Effective date— The amendments made by this section shall apply to items and services furnished on or after January 1, 2023.
126. Distribution of additional residency positions
in paragraph (4)(F)(i), by striking “paragraphs (7) and (8)” and inserting “paragraphs (7), (8), and (9)”;
in paragraph (4)(H)(i), by striking “paragraphs (7) and (8)” and inserting “paragraphs (7), (8), and (9)”;
in paragraph (7)(E), by inserting “paragraph (9),” after “paragraph (8),”; and
by adding at the end the following new paragraph:
“(9) Distribution of additional residency positions
“(A) Additional residency positions
“(i) In general—For fiscal year 2023, and for each succeeding fiscal year until the aggregate number of full-time equivalent residency positions distributed under this paragraph is equal to the aggregate number of such positions made available (as specified in clause (ii)(I)), the Secretary shall, subject to the succeeding provisions of this paragraph, increase the otherwise applicable resident limit for each qualifying hospital (as defined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Secretary may approve effective beginning July 1 of the fiscal year of the increase.
“(ii) Number available for distribution
“(I) Total number available—The aggregate number of such positions made available under this paragraph shall be equal to 1,000.
“(II) Annual limit—The aggregate number of such positions so made available shall not exceed 200 for a fiscal year.
“(iii) Process for distributing positions
“(I) Rounds of applications—The Secretary shall initiate a separate round of applications for an increase under clause (i) for each fiscal year for which such an increase is to be provided.
“(II) Timing—The Secretary shall notify hospitals of the number of positions distributed to the hospital under this paragraph as a result of an increase in the otherwise applicable resident limit by January 31 of the fiscal year of the increase. Such increase shall be effective beginning July 1 of such fiscal year.
“(B) Distribution—For purposes of providing an increase in the otherwise applicable resident limit under subparagraph (A), the following shall apply:
“(i) Considerations in distribution—In determining for which qualifying hospitals such an increase is provided under subparagraph (A), the Secretary shall take into account the demonstrated likelihood of the hospital filling the positions made available under this paragraph within the first 5 training years beginning after the date the increase would be effective, as determined by the Secretary.
“(ii) Minimum distribution for certain categories of hospitals—With respect to the aggregate number of such positions available for distribution under this paragraph, the Secretary shall distribute not less than 10 percent of such aggregate number to each of the following categories of hospitals:
“(I) Hospitals that are located in a rural area (as defined in section 1886(d)(2)(D)) or are treated as being located in a rural area pursuant to section 1886(d)(8)(E).
“(II) Hospitals in which the reference resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applicable resident limit.
“(III) Hospitals in States with—
“(aa) new medical schools that received “Candidate School” status from the Liaison Committee on Medical Education or that received “Pre-Accreditation” status from the American Osteopathic Association Commission on Osteopathic College Accreditation on or after January 1, 2000, and that have achieved or continue to progress toward “Full Accreditation” status (as such term is defined by the Liaison Committee on Medical Education) or toward “Accreditation” status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation); or
“(bb) additional locations and branch campuses established on or after January 1, 2000, by medical schools with “Full Accreditation” status (as such term is defined by the Liaison Committee on Medical Education) or “Accreditation” status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation).
“(IV) Hospitals that serve areas designated as health professional shortage areas under section 332(a)(1)(A) of the Public Health Service Act, as determined by the Secretary.
“(C) Limitations
“(i) In general—A hospital may not receive more than 25 additional full-time equivalent residency positions under this paragraph.
“(ii) Prohibition on distribution to hospitals without an increase agreement—No increase in the otherwise applicable resident limit of a hospital may be made under this paragraph unless such hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of such hospital by the number of such positions made available by such increase under this paragraph.
“(D) Application of per resident amounts for primary care and nonprimary care—With respect to additional residency positions in a hospital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for primary care and nonprimary care computed under paragraph (2)(D) for that hospital.
“(E) Permitting facilities to apply aggregation rules—The Secretary shall permit hospitals receiving additional residency positions attributable to the increase provided under this paragraph to, beginning in the fifth year after the effective date of such increase, apply such positions to the limitation amount under paragraph (4)(F) that may be aggregated pursuant to paragraph (4)(H) among members of the same affiliated group.
“(F) Definitions—In this paragraph:
“(i) Otherwise applicable resident limit—The term otherwise applicable resident limit means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account paragraphs (7)(A), (7)(B), (8)(A), and (8)(B).
“(ii) Qualifying hospital—The term “qualifying hospital” means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii).
“(iii) Reference resident level—The term reference resident level means, with respect to a hospital, the resident level for the most recent cost reporting period of the hospital ending on or before the date of enactment of this paragraph, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.
“(iv) Resident level—The term resident level has the meaning given such term in paragraph (7)(C)(i).”
in clause (v), in the third sentence, by striking “and (h)(8)” and inserting “(h)(8), and (h)(9)”;
by redesignating clause (x), as added by section 5505(b) of the Patient Protection and Affordable Care Act (Public Law 111–148), as clause (xi) and moving such clause 4 ems to the left; and
by adding after clause (xi), as redesignated by subparagraph (A), the following new clause:
“(xii) For discharges occurring on or after July 1, 2023, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(9), the indirect teaching adjustment factor shall be computed in the same manner as provided under clause (ii) with respect to such resident positions.”
Prohibition on judicial review— Section 1886(h)(7)(E) of the Social Security Act (42 U.S.C. 1395ww–4(h)(7)(E)) is amended by inserting “paragraph (9),” after “paragraph (8),”.
Reports—
In general— Not later than September 30, 2025, and again not later than September 30, 2027, the Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall conduct a study and submit to Congress a report on—
the distribution of additional full-time equivalent resident positions under paragraph (9) of section 1886(h) of the Social Security Act, as added by subsection (a); and
rural track and rotator programs under such section.
Contents— Each report described in paragraph (1) shall include—
a description of the distribution described in paragraph (1)(A) and an analysis of the use of such positions so distributed, including a description of the effects of such distribution on rural track and rotator programs;
a specification, with respect to each hospital that has received such a distribution, of whether such hospital has abided by the agreement described in paragraph (9)(C)(ii) of section 1886(h) of the Social Security Act, as added by subsection (a); and
to the extent practicable, a description of—
the type of program in which each such position so distributed is being used;
the total number of full-time equivalent residency positions available in each such program;
the number of instances in which residents filling such positions so distributed treated individuals entitled to benefits under part A, or enrolled under part B, of title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.);
the location where each resident that filled a position so distributed went on to practice.
127. Promoting Rural Hospital GME Funding Opportunity
Section 1886(h)(4)(H)(iv) of the Social Security Act (42 U.S.C. 1395ww(h)(4)(iv)) is amended—
by striking “(iv) Nonrural hospital operating training programs in rural areas.—In the case of” and inserting the following:
“(iv) Training programs in rural areas
“(I) Cost reporting periods beginning before October 1, 2022—For cost reporting periods beginning before October 1, 2022, in the case of”
by adding at the end the following new subclause:
“(II) Cost reporting periods beginning on or after October 1, 2022—For cost reporting periods beginning on or after October 1, 2022, in the case of a hospital not located in a rural area that established or establishes a medical residency training program (or rural tracks) in a rural area or establishes an accredited program where greater than 50 percent of the program occurs in a rural area, the Secretary shall consistent with the principles of subparagraphs (F) and (G) and subject to paragraphs (7) and (8), prescribe rules for the application of such subparagraphs with respect to such a program and, in accordance with such rules, adjust in an appropriate manner the limitation under subparagraph (F) for such hospital and each such hospital located in a rural area that participates in such a training.”
128. Five-year extension of the rural community hospital demonstration program
Extension—
In general— Subsection (a)(5) of section 410A of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173; 42 U.S.C. 1395ww note), is amended by striking “10-year extension period” and inserting “15-year extension period”.
Conforming amendments for extension—
in the subsection heading, by striking “Ten-Year” and inserting “Fifteen-Year”;
in paragraph (1)—
by striking “additional 10-year” and inserting “additional 15-year”; and
by striking “10-year extension period” and inserting “15-year extension period”;
in paragraph (2), by striking “10-year extension period” and inserting “15-year extension period”;
in paragraph (3), by striking “10-year extension period” and inserting “15-year extension period”;
in paragraph (4), by striking “10-year extension period” each place it appears and inserting “15-year extension period”;
in paragraph (5), by striking “10-year extension period” and inserting “15-year extension period”; and
in subparagraph (A) of paragraph (6), by striking “10-year extension period” and inserting “15-year extension period”.
Rule for hospitals that are not original participants in the demonstration— Paragraph (5) of subsection (g) of such section 410A is amended—
by striking “program.—During” and inserting
“(A) CURES Act extension—During”
by adding at the end the following new subparagraph:
“(B) Additional extension—During the third 5 years of the 15-year extension period, the Secretary shall apply the provisions of paragraph (4) to rural community hospitals that are not described in paragraph (4) but are participating in the demonstration program under this section as of December 30, 2019, in a similar manner as such provisions apply to rural community hospitals described in paragraph (4).”
Clarifying technical amendments— Such section 410A, as amended by subsection (a), is further amended—
in subsection (a)(1), by inserting “of Health and Human Services” after “Secretary”;
in subsection (f)(1)(A)(iv) by inserting “of the Social Security Act (42 U.S.C. 1395i–4)” after “section 1820”; and
in subsection (g)—
in the heading of paragraph (4), by striking “Hospitals in demonstration program on date of enactment” and inserting “Hospitals participating in the demonstration program during the initial 5-year period”; and
in paragraph (6)(A), by striking “not later than 120 days after the date of the enactment of this paragraph” and inserting “not later than April 12, 2017”.
129. Extension of Frontier Community Health Integration Project Demonstration
In general— Subsection (f) of section 123 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395i–4 note) is amended—
in paragraph (1), by striking “3-year period beginning on October 1, 2009” and inserting “3-year period beginning on August 1, 2016 (referred to in this section as the “initial period”), and 5-year period beginning on July 1, 2021 (referred to in this section as the “extension period”)”;
in paragraph (2)—
by striking “project.—The demonstration” and inserting “project.—
“(A) Initial period—During the initial period, the demonstration”
by adding at the end the following new subparagraph:
“(B) Extension period—During the extension period, the demonstration project under this section shall be considered to have begun in a State on the date during such period on which the eligible counties selected to participate in the demonstration project under subsection (d)(3) begin operations in accordance with the requirements under the demonstration project.”
by adding at the end the following new paragraph:
“(3) Re-entry on a rolling basis for extension period—A critical access hospital participating in the demonstration project under this section during the extension period shall begin such participation in the cost reporting year that begins on or after July 1, 2021.”
in subparagraph (B), in the matter preceding clause (i), by striking “In this section” and inserting “Subject to subparagraph (C), in this section”; and
by adding at the end the following new subparagraph:
“(C) Extension period—An entity shall only be eligible to participate in the demonstration project under this section during the extension period if the entity participated in the demonstration project under this section during the initial period.”
in subparagraph (A)—
by striking “In general” and inserting “Initial period”; and
by inserting “with respect to the initial period” before the period at the end; and
by adding at the end the following new subparagraph:
“(C) Extension period—The Secretary shall provide for the transfer of $10,000,000, in appropriate part from the Federal Hospital Insurance Trust Fund established under section 1817 of the Social Security Act (42 U.S.C. 1395i) and the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of such Act (42 U.S.C. 1395t), to the Centers for Medicare & Medicaid Services for the purposes of carrying out its duties under the demonstration project under this section with respect to the extension period.”
130. Improving rural health clinic payments
Section 1833(f) of the Social Security Act (42 U.S.C. 1395l(f)) is amended—
in paragraph (2)—
by inserting “(before April 1, 2021)” after “in a subsequent year”; and
by striking “this subsection” and inserting “this paragraph”;
by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively;
in the matter preceding subparagraph (A), as redesignated by paragraph (2)—
by inserting “(1)” after “(f)”; and
by inserting “prior to April 1, 2021” after “services provided”; and
by adding at the end the following new paragraphs:
“(2) In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after April 1, 2021, by a rural health clinic (other than a rural health clinic described in paragraph (3)(B)), the Secretary shall establish such limit, for services provided—
“(A) in 2021, after March 31, at $100 per visit;
“(B) in 2022, at $113 per visit;
“(C) in 2023, at $126 per visit;
“(D) in 2024, at $139 per visit;
“(E) in 2025, at $152 per visit;
“(F) in 2026, at $165 per visit;
“(G) in 2027, at $178 per visit;
“(H) in 2028, at $190 per visit; and
“(I) in a subsequent year, at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year.
“(3)
“(A) In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after April 1, 2021, by a rural health clinic described in subparagraph (B), the Secretary shall establish such limit, with respect to each such rural health clinic, for services provided—
“(i) in 2021, after March 31, at an amount equal to the greater of—
“(I) the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or
“(II) the limit described in paragraph (2)(A); and
“(ii) in a subsequent year, at an amount equal to the greater of—
“(I) the amount established under clause (i)(I) or this subclause for the previous year with respect to such rural health clinic, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year; or
“(II) the limit established under paragraph (2) for such subsequent year.
“(B) A rural health clinic described in this subparagraph is a rural health clinic that, as of December 31, 2019, was—
“(i) in a hospital with less than 50 beds; and
“(ii) enrolled under section 1866(j).”
131. Medicare GME treatment of hospitals establishing new medical residency training programs after hosting medical resident rotators for short durations
Redetermination of approved FTE resident amount— Section 1886(h)(2)(F) of the Social Security Act (42 U.S.C. 1395ww(h)(2)(F)) is amended—
by inserting “(i)” before “In the case of”; and
by adding at the end the following:
“(ii) In applying this subparagraph in the case of a hospital that trains residents and has not entered into a GME affiliation agreement (as defined by the Secretary for purposes of paragraph (4)(H)(ii)), on or after the date of the enactment of this clause, the Secretary shall not establish an FTE resident amount until such time as the Secretary determines that the hospital has trained at least 1.0 full-time-equivalent resident in an approved medical residency training program in a cost reporting period.
“(iii) In applying this subparagraph for cost reporting periods beginning on or after the date of enactment of this clause, in the case of a hospital that, as of such date of enactment, has an approved FTE resident amount based on the training in an approved medical residency program or programs of—
“(I) less than 1.0 full-time-equivalent resident in any cost reporting period beginning before October 1, 1997, as determined by the Secretary; or
“(II) no more than 3.0 full-time-equivalent residents in any cost reporting period beginning on or after October 1, 1997, and before the date of the enactment of this clause, as determined by the Secretary,
“(iv) For purposes of carrying out this subparagraph for cost reporting periods beginning on or after the date of the enactment of this clause, a hospital shall report full-time-equivalent residents on its cost report for a cost reporting period if the hospital trains at least 1.0 full-time-equivalent residents in an approved medical residency training program or programs in such period.
“(v) As appropriate, the Secretary may consider information from any cost reporting period necessary to establish a new FTE resident amount as described in clause (iii).”
Redetermination of FTE resident limitation— Section 1886(h)(4)(H)(i) of the Social Security Act (42 U.S.C. 1395ww(h)(4)(H)(i)) is amended—
by inserting “(I)” before “The Secretary”; and
by adding at the end the following:
“(II) In applying this clause in the case of a hospital that, on or after the date of the enactment of this subclause, begins training residents in a new approved medical residency training program or programs (as defined by the Secretary), the Secretary shall not determine a limitation applicable to the hospital under subparagraph (F) until such time as the Secretary determines that the hospital has trained at least 1.0 full-time-equivalent resident in such new approved medical residency training program or programs in a cost reporting period.
“(III) In applying this clause in the case of a hospital that, as of the date of the enactment of this subclause, has a limitation under subparagraph (F), based on a cost reporting period beginning before October 1, 1997, of less than 1.0 full-time-equivalent resident, the Secretary shall adjust the limitation in the manner applicable to a new approved medical residency training program if the Secretary determines the hospital begins training at least 1.0 full-time-equivalent residents in a program year beginning on or after such date of enactment and before the date that is 5 years after such date of enactment.
“(IV) In applying this clause in the case of a hospital that, as of the date of the enactment of this subclause, has a limitation under subparagraph (F), based on a cost reporting period beginning on or after October 1, 1997, and before such date of enactment, of no more than 3.0 full-time-equivalent residents, the Secretary shall adjust the limitation in the manner applicable to a new approved medical residency training program if the Secretary determines the hospital begins training more than 3.0 full-time-equivalent residents in a program year beginning on or after such date of enactment and before the date that is 5 years after such date of enactment.
“(V) An adjustment to the limitation applicable to a hospital made pursuant to subclause (III) or (IV) shall be made in a manner consistent with the methodology, as appropriate, in section 413.79(e) of title 42, Code of Federal Regulations (or any successor regulation). As appropriate, the Secretary may consider information from any cost reporting periods necessary to make such an adjustment to the limitation.”
Technical and conforming amendments— Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is amended—
in subsection (d)(5)(B)(viii), by striking “subsection (h)(4)(H)” and inserting “paragraphs (2)(F)(iv) and (4)(H) of subsection (h)”; and
in subsection (h)—
in paragraph (4)(H)(iv), by striking “an rural area” and inserting “a rural area”; and
in paragraph (7)(E), by striking “under this” and all that follows through the period at the end and inserting the following: “under this paragraph, paragraph (8), clause (i), (ii), (iii), or (v) of paragraph (2)(F), or clause (i) or (vi) of paragraph (4)(H).”.
Effective date— The amendments made by this section shall apply to payment under section 1886 of the Social Security Act (42 U.S.C. 1395ww) for cost reporting periods beginning on or after the date of the enactment of this Act.
132. Medicare payment for certain Federally qualified health center and rural health clinic services furnished to hospice patients
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 125(a)(2)(B), is amended—
in subsection (o), by adding at the end the following new paragraph:
“(4) Payment for attending physician services furnished by Federally qualified health centers to hospice patients—In the case of services described in section 1812(d)(2)(A)(ii) furnished on or after January 1, 2022, by an attending physician (as defined in section 1861(dd)(3)(B), other than a physician or practitioner who is employed by a hospice program) who is employed by or working under contract with a Federally qualified health center, a Federally qualified health center shall be paid for such services under the prospective payment system under this subsection.”
by adding at the end the following new subsection:
“(y) Payment for attending physician services furnished by rural health clinics to hospice patients—In the case of services described in section 1812(d)(2)(A)(ii) furnished on or after January 1, 2022, by an attending physician (as defined in section 1861(dd)(3)(B), other than a physician or practitioner who is employed by a hospice program) who is employed by or working under contract with a rural health clinic, a rural health clinic shall be paid for such services under the methodology for all-inclusive rates (established by the Secretary) under section 1833(a)(3), subject to the limits described in section 1833(f).”
133. Delay to the implementation of the radiation oncology model under the Medicare program
Notwithstanding any provision of section 1115A of the Social Security Act (42 U.S.C. 1315a), the Secretary of Health and Human Services may not implement the radiation oncology model described in the rule entitled “Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures” (85 Fed. Reg. 61114 et seq.), or any substantially similar model, pursuant to such section before January 1, 2022.
134. Improving access to skilled nursing facility services for hemophilia patients
In general— Section 1888(e)(2)(A)(iii) of the Social Security Act (42 U.S.C. 1395yy(e)(2)(A)(iii)) is amended by adding at the end the following:
“(VI) Blood clotting factors indicated for the treatment of patients with hemophilia and other bleeding disorders (identified as of July 1, 2020, by HCPCS codes J7170, J7175, J7177–J7183, J7185–J7190, J7192–J7195, J7198–J7203, J7205, J7207–J7211, and as subsequently modified by the Secretary) and items and services related to the furnishing of such factors under section 1842(o)(5)(C), and any additional blood clotting factors identified by the Secretary and items and services related to the furnishing of such factors under such section.”
Effective date— The amendment made by subsection (a) shall apply to items and services furnished on or after October 1, 2021.
II Medicaid Extenders and Other Policies
201. Eliminating DSH reductions for fiscal years 2021 through 2023
Section 1923(f) of the Social Security Act (42 U.S.C. 1396r–4(f)), as amended by section 1106 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended—
in paragraph (7)(A)—
in clause (i), in the matter preceding subclause (I), by striking “For the period” and all that follows through “2025” and inserting “For each of fiscal years 2024 through 2027,”; and
in clause (ii), by striking “equal to—” and all that follows through the period at the end and inserting “equal to $8,000,000,000 for each of fiscal years 2024 through 2027”; and
in paragraph (8), by striking “2025” and inserting “2027”.
202. Supplemental payment reporting requirements
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended by adding at the end the following new subsection:
“(bb) Supplemental payment reporting requirements
“(1) Collection and availability of supplemental payment data
“(A) In general—Not later than October 1, 2021, the Secretary shall establish a system for each State to submit reports, as determined appropriate by the Secretary, on supplemental payments data, as a requirement for a State plan or State plan amendment that would provide for a supplemental payment.
“(B) Requirements—Each report submitted by a State in accordance with the requirement established under subparagraph (A) shall include the following:
“(i) An explanation of how supplemental payments made under the State plan or a State plan amendment will result in payments that are consistent with section 1902(a)(30)(A), including standards with respect to efficiency, economy, quality of care, and access, along with the stated purpose and intended effects of the supplemental payment.
“(ii) The criteria used to determine which providers are eligible to receive the supplemental payment.
“(iii) A comprehensive description of the methodology used to calculate the amount of, and distribute, the supplemental payment to each eligible provider, including—
“(I) data on the amount of the supplemental payment made to each eligible provider, if known, or, if the total amount is distributed using a formula based on data from 1 or more fiscal years, data on the total amount of the supplemental payments for the fiscal year or years available to all providers eligible to receive a supplemental payment;
“(II) if applicable, the specific criteria with respect to Medicaid service, utilization, or cost data to be used as the basis for calculations regarding the amount or distribution of the supplemental payment; and
“(III) the timing of the supplemental payment made to each eligible provider.
“(iv) An assurance that the total Medicaid payments made to an inpatient hospital provider, including the supplemental payment, will not exceed upper payment limits.
“(v) If not already submitted, an upper payment limit demonstration under section 447.272 of title 42, Code of Federal Regulations (as such section is in effect as of the date of enactment of this subsection).
“(C) Public availability—The Secretary shall make all reports and related data submitted under this paragraph publicly available on the website of the Centers for Medicare & Medicaid Services on a timely basis.
“(2) Supplemental payment defined
“(A) In general—Subject to subparagraph (B), in this subsection, the term “supplemental payment” means a payment to a provider that is in addition to any base payment made to the provider under the State plan under this title or under demonstration authority.
“(B) DSH payments excluded—Such term does not include a disproportionate share hospital payment made under section 1923.”
203. Medicaid shortfall and third party payments
In general— Subsection (g) of section 1923 of the Social Security Act (42 U.S.C. 1396r–4) is amended to read as follows:
“(g) Limit on amount of payment to hospital
“(1) In general
“(A) Amount of adjustment subject to uncompensated costs—A payment adjustment during a fiscal year shall not be considered to be consistent with subsection (c) with respect to a hospital (other than a hospital described in paragraph (2)(B)) if the payment adjustment exceeds an amount equal to—
“(i) the costs incurred during the year of furnishing hospital services by the hospital to individuals described in subparagraph (B) minus—
“(ii) the sum of—
“(I) payments under this title (other than under this section) for such services; and
“(II) payments by uninsured patients for such services.
“(B) Individuals described—For purposes of subparagraph (A), the individuals described in this clause are the following:
“(i) Individuals who are eligible for medical assistance under the State plan or under a waiver of such plan and for whom the State plan or waiver is the primary payor for such services.
“(ii) Subject to subparagraph (C), individuals who have no health insurance (or other source of third party coverage) for services provided during the year, as determined by the Secretary.
“(C) Exclusion of certain payments—For purposes of subparagraph (B)(ii), payments made to a hospital for services provided to indigent patients made by a State or a unit of local government within a State shall not be considered to be a source of third party coverage.
“(2) Application of limits for certain hospitals
“(A) In general—A payment adjustment during a fiscal year shall not be considered to be consistent with subsection (c) with respect to a hospital described in subparagraph (B) if the payment adjustment exceeds the higher of—
“(i) the amount determined for the hospital and fiscal year under paragraph (1)(A); and
“(ii) the amount determined for the hospital under paragraph (1)(A) as in effect on January 1, 2020.
“(B) Hospitals described—A hospital is described in this subparagraph for a fiscal year if, for the most recent cost reporting period, the hospital is in at least the 97th percentile of all hospitals with respect to—
“(i) the number of inpatient days for such period that were made up of patients who (for such days) were entitled to benefits under part A of title XVIII and were entitled to supplemental security income benefits under title XVI (excluding any State supplementary benefits paid with respect to such patients); or
“(ii) the percentage of total inpatient days that were made up of patients who (for such days) were described in clause (i).”
Effective date— The amendment made by this section shall take effect on October 1, 2021, and shall apply to payment adjustments made under section 1923 of the Social Security Act (42 U.S.C. 1396r–4) during fiscal years beginning on or after such date.
204. Extension of Money Follows the Person Rebalancing Demonstration
In general—
in paragraph (1)—
in each of subparagraphs (F) through (H), by striking “subject to paragraph (3),”;
in subparagraph (G), by striking “and” at the end;
in subparagraph (H), by striking the period and inserting a semicolon; and
by adding at the end the following new subparagraphs:
“(I) for the period beginning on December 19, 2020, and ending on September 30, 2021, the amount equal to the pro rata portion of an annual appropriation of $450,000,000;
“(J) $450,000,000 for fiscal year 2022; and
“(K) $450,000,000 for fiscal year 2023.”
in paragraph (2)—
by striking “Subject to paragraph (3), amounts” and inserting “Amounts”; and
by striking “2021” and inserting “2023”; and
by striking paragraph (3).
Research and evaluation— Section 6071(g) of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended—
in paragraph (2), by striking “2016” and inserting “2026”; and
in paragraph (3), by inserting “and for each of fiscal years 2021 through 2023” after “2016,”.
Changes to institutional residency period requirement—
In general— Section 6071(b)(2) of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended—
in subparagraph (A)(i), by striking “90” and inserting “60”; and
by striking the flush sentence after subparagraph (B).
Effective date— The amendments made by paragraph (1) shall take effect on the date that is 30 days after the date of the enactment of this Act.
Updates to State application requirements— Section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended—
in subsection (c)—
in paragraph (3), by striking “, which shall include” and all that follows through “2007”;
in paragraph (7)—
in the paragraph heading, by striking “Rebalancing” and inserting “Expenditures”;
in subparagraph (A), by adding “and” at the end; and
in subparagraph (B)—
in clause (i), by striking “and” at the end;
in clause (ii), by striking the period at the end and inserting a semicolon; and
by adding at the end the following:
“(iii) include a work plan that describes for each Federal fiscal year that occurs during the proposed MFP demonstration project—
“(I) the use of grant funds for each proposed initiative that is designed to accomplish the objective described in subsection (a)(1), including a funding source for each activity that is part of each such proposed initiative;
“(II) an evaluation plan that identifies expected results for each such proposed initiative; and
“(III) a sustainability plan for components of such proposed initiatives that are intended to improve transitions, which shall be updated with actual expenditure information for each Federal fiscal year that occurs during the MFP demonstration project; and
“(iv) contain assurances that grant funds used to accomplish the objective described in subsection (a)(1) shall be obligated not later than 24 months after the date on which the funds are awarded and shall be expended not later than 60 months after the date on which the funds are awarded (unless the Secretary waives either such requirement).”
in paragraph (13)—
in subparagraph (A), by striking “; and” and inserting “, and in such manner as will meet the reporting requirements set forth for the Transformed Medicaid Statistical Information System (T–MSIS);”;
by redesignating subparagraph (B) as subparagraph (D); and
by inserting after subparagraph (A) the following:
“(B) the State shall report on a quarterly basis on the use of grant funds by distinct activity, as described in the approved work plan, and by specific population as targeted by the State;
“(C) if the State fails to report the information required under subparagraph (B), fails to report such information on a quarterly basis, or fails to make progress under the approved work plan, the State shall implement a corrective action plan approved by the Secretary; and”
in subsection (d)(4), by adding at the end the following new subparagraph:
“(C) Corrective action plan progress—In the case of a State required to implement a corrective action plan under subparagraph (C) of subsection (c)(13), the State must implement such plan and demonstrate progress in reporting information under subparagraph (B) of such subsection or progress under the approved work plan (as applicable).”
Funding for quality assurance and improvement; Technical assistance; Oversight— Section 6071(f) of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended by striking paragraph (2) and inserting the following:
“(2) Funding—From the amounts appropriated under subsection (h)(1), $3,000,000 shall be available to the Secretary to carry out this subsection. Such amount shall remain available until expended.”
Best practices evaluation— Section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended by adding at the end the following:
“(i) Best practices
“(1) Report—The Secretary, directly or through grant or contract, shall submit a report to the President and Congress not later than September 30, 2022, that contains findings and conclusions on best practices from MFP demonstration projects carried out with grants made under this section. The report shall include information and analyses with respect to the following:
“(A) The most effective State strategies for transitioning beneficiaries from institutional to qualified community settings carried out under MFP demonstration projects and how such strategies may vary for different types of beneficiaries, such as beneficiaries who are aged, physically disabled, intellectually or developmentally disabled, or individuals with serious mental illnesses, and other targeted waiver beneficiary populations under section 1915(c) of the Social Security Act.
“(B) The most common and the most effective State uses of grant funds carried out under demonstration projects for transitioning beneficiaries from institutional to qualified community settings and improving health outcomes, including differentiating funding for current initiatives that are designed for such purpose and funding for proposed initiatives that are designed for such purpose.
“(C) The most effective State approaches carried out under MFP demonstration projects for improving person-centered care and planning.
“(D) Identification of program, financing, and other flexibilities available under MFP demonstration projects, that are not available under the traditional Medicaid program, and which directly contributed to successful transitions and improved health outcomes under MFP demonstration projects.
“(E) State strategies and financing mechanisms for effective coordination of housing financed or supported under MFP demonstration projects with local housing authorities and other resources.
“(F) Effective State approaches for delivering Money Follows the Person transition services through managed care entities.
“(G) Other best practices and effective transition strategies demonstrated by States with approved MFP demonstration projects, as determined by the Secretary.
“(H) Identification and analyses of opportunities and challenges to integrating effective Money Follows the Person practices and State strategies into the traditional Medicaid program.
“(2) Collaboration—In preparing the report required under this subsection, the Secretary shall collect and incorporate information from States with approved MFP demonstration projects and beneficiaries participating in such projects, and providers participating in such projects.
“(3) Waiver of Paperwork Reduction Act—Chapter 35 of title 44, United States Code, shall not apply to preparation of the report described in paragraph (1) or collection of information described in paragraph (2).
“(4) Funding—From the amounts appropriated under subsection (h)(1) for each of fiscal years 2021 and 2022, not more than $300,000 shall be available to the Secretary for each such fiscal year to carry out this subsection.”
MACPAC report on qualified settings criteria— Section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note), as amended by subsection (e), is further amended by adding at the end the following:
“(j) MACPAC report—Prior to the final implementation date established by the Secretary for the criteria established for home and community-based settings in section 441.301(c)(4) of title 42, Code of Federal Regulations, as part of final implementation of the Home and Community Based Services (HCBS) Final Rule published on January 16, 2014 (79 Fed. Reg. 2947) (referred to in this subsection as the HCBS final rule), the Medicaid and CHIP Payment and Access Commission (MACPAC) shall submit to Congress a report that—
“(1) identifies the types of home and community-based settings and associated services that are available to eligible individuals in both the MFP demonstration program and sites in compliance with the HCBS final rule; and
“(2) if determined appropriate by the Commission, recommends policies to align the criteria for a qualified residence under subsection (b)(6) (as in effect on October 1, 2017) with the criteria in the HCBS final rule.”
Application to current projects— Not later than 1 year after the date of the enactment of this Act, the Secretary shall update the terms and conditions of any approved MFP demonstration project under section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) in effect on the date of the enactment of this Act to ensure that such terms and conditions are the same as are required for any new State applicant for such project under the amendments made by this section.
205. Extension of spousal impoverishment protections
In general— Section 2404 of the Patient Protection and Affordable Care Act (42 U.S.C. 1396r-5 note) is amended by striking “December 18, 2020” and inserting “September 30, 2023”.
Rule of construction— Nothing in section 2404 of Public Law 111–148 (42 U.S.C. 1396r-5 note) or section 1902(a)(17) or 1924 of the Social Security Act (42 U.S.C. 1396a(a)(17), 1396r-5) shall be construed as prohibiting a State from—
applying an income or resource disregard under a methodology authorized under section 1902(r)(2) of such Act (42 U.S.C. 1396a(r)(2))—
to the income or resources of an individual described in section 1902(a)(10)(A)(ii)(VI) of such Act (42 U.S.C. 1396a(a)(10)(A)(ii)(VI)) (including a disregard of the income or resources of such individual's spouse); or
on the basis of an individual's need for home and community-based services authorized under subsection (c), (d), (i), or (k) of section 1915 of such Act (42 U.S.C. 1396n) or under section 1115 of such Act (42 U.S.C. 1315); or
disregarding an individual's spousal income and assets under a plan amendment to provide medical assistance for home and community-based services for individuals by reason of being determined eligible under section 1902(a)(10)(C) of such Act (42 U.S.C. 1396a(a)(10)(C)) or by reason of section 1902(f) of such Act (42 U.S.C. 1396a(f)) or otherwise on the basis of a reduction of income based on costs incurred for medical or other remedial care under which the State disregarded the income and assets of the individual's spouse in determining the initial and ongoing financial eligibility of an individual for such services in place of the spousal impoverishment provisions applied under section 1924 of such Act (42 U.S.C. 1396r-5).
206. Extension of community mental health services demonstration program
Section 223(d) of the Protecting Access to Medicare Act of 2014 (42 U.S.C. 1396a note), as amended by section 1104 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended—
in paragraph (3), by striking “under this subsection” and all that follows through the period and inserting “that meet the requirements of this subsection through September 30, 2023.”;
in paragraph (5)(C)(iii)(I), by striking “during the 8 fiscal quarter period (or any portion of the period) that begins on January 1, 2020” and inserting “through September 30, 2023”;
in paragraph (5)(C)(iii)(II), by inserting before the period at the end “or through September 30, 2023, whichever is longer”;
in paragraph (8)(A), by striking “to participate” and all that follows through the period and inserting “to conduct demonstration programs that meet the requirements of this subsection for 2 years or through September 30, 2023, whichever is longer.”.
207. Clarifying authority of State Medicaid fraud and abuse control units to investigate and prosecute cases of Medicaid patient abuse and neglect in any setting
In general— Section 1903(q)(4)(A)(ii) of the Social Security Act (42 U.S.C. 1396b(q)(4)(A)(ii)) is amended by inserting after “patients residing in board and care facilities” the following: “and of patients (who are receiving medical assistance under the State plan under this title (or waiver of such plan)) in a noninstitutional or other setting”.
Availability of funding— Section 1903(a)(6) of the Social Security Act (42 U.S.C. 1396b(a)(6)) is amended, in the matter following subparagraph (B), by striking “(as found necessary by the Secretary for the elimination of fraud in the provision and administration of medical assistance provided under the State plan (or waiver of such plan))”.
208. Medicaid coverage for citizens of Freely Associated States
In general— Section 402(b)(2) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1612(b)(2)) is amended by adding at the end the following new subparagraph:
“(G) Medicaid exception for citizens of Freely Associated States—With respect to eligibility for benefits for the designated Federal program defined in paragraph (3)(C) (relating to the Medicaid program), paragraph (1) shall not apply to any individual who lawfully resides in 1 of the 50 States or the District of Columbia in accordance with the Compacts of Free Association between the Government of the United States and the Governments of the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau and shall not apply, at the option of the Governor of Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa as communicated to the Secretary of Health and Human Services in writing, to any individual who lawfully resides in the respective territory in accordance with such Compacts.”
Exception to 5–Year limited eligibility— Section 403(b) of such Act (8 U.S.C. 1613(b)) is amended by adding at the end the following new paragraph:
“(3) Exception for citizens of freely associated States—An individual described in section 402(b)(2)(G), but only with respect to the designated Federal program defined in section 402(b)(3)(C).”
in paragraph (6), by striking “; or” at the end and inserting a comma;
in paragraph (7), by striking the period at the end and inserting “, or”; and
by adding at the end the following new paragraph:
“(8) an individual who lawfully resides in the United States in accordance with a Compact of Free Association referred to in section 402(b)(2)(G), but only with respect to the designated Federal program defined in section 402(b)(3)(C) (relating to the Medicaid program).”
in subsection (f), in the matter preceding paragraph (1), by striking “subsection (g) and section 1935(e)(1)(B)” and inserting “subsections (g) and (h) and section 1935(e)(1)(B)”; and
by adding at the end the following:
“(h) Exclusion of medical assistance expenditures for citizens of Freely Associated States—Expenditures for medical assistance provided to an individual described in section 431(b)(8) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1641(b)(8)) shall not be taken into account for purposes of applying payment limits under subsections (f) and (g).”
Effective date— The amendments made by this section shall apply to benefits for items and services furnished on or after the date of the enactment of this Act.
209. Medicaid coverage of certain medical transportation
Continuing requirement of medicaid coverage of necessary transportation—
by striking “and including provision for utilization” and inserting “including provision for utilization”; and
by inserting after “supervision of administration of the plan” the following: “, and, subject to section 1903(i), including a specification that the single State agency described in paragraph (5) will ensure necessary transportation for beneficiaries under the State plan to and from providers and a description of the methods that such agency will use to ensure such transportation”.
Application with respect to benchmark benefit packages and benchmark equivalent coverage— Section 1937(a)(1) of the Social Security Act (42 U.S.C. 1396u–7(a)(1)) is amended—
in subparagraph (A), by striking “subsection (E)” and inserting “subparagraphs (E) and (F)”; and
by adding at the end the following new subparagraph:
“(F) Necessary transportation—Notwithstanding the preceding provisions of this paragraph, a State may not provide medical assistance through the enrollment of an individual with benchmark coverage or benchmark equivalent coverage described in subparagraph (A)(i) unless, subject to section 1903(i)(9) and in accordance with section 1902(a)(4), the benchmark benefit package or benchmark equivalent coverage (or the State)—
“(i) ensures necessary transportation for individuals enrolled under such package or coverage to and from providers; and
“(ii) provides a description of the methods that will be used to ensure such transportation.”
Limitation on federal financial participation— Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) is amended by inserting after paragraph (8) the following new paragraph:
“(9) with respect to any amount expended for non-emergency transportation authorized under section 1902(a)(4), unless the State plan provides for the methods and procedures required under section 1902(a)(30)(A); or”
Effective date— The amendments made by this subsection shall take effect on the date of the enactment of this Act and shall apply to transportation furnished on or after such date.
Medicaid program integrity measures related to coverage of nonemergency medical transportation—
Gao study— Not later than two years after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress, a report on coverage under the Medicaid program under title XIX of the Social Security Act of nonemergency transportation to services. Such study shall take into account the 2009 report of the Office of the Inspector General of the Department of Health and Human Services, titled “Fraud and Abuse Safeguards for State Medicaid Nonemergency Medical Transportation Services” (OEI–06–07–00320). Such report shall include the following:
An examination of the 50 States and the District of Columbia to identify safeguards to prevent and detect fraud and abuse with respect to coverage under the Medicaid program of nonemergency transportation to covered services.
An examination of transportation brokers to identify the range of safeguards against such fraud and abuse to prevent improper payments for such transportation.
Identification of the numbers, types, and outcomes of instances of fraud and abuse, with respect to coverage under the Medicaid program of such transportation, that State Medicaid Fraud Control Units have investigated in recent years.
Identification of commonalities or trends in program integrity, with respect to such coverage, to inform risk management strategies of States and the Centers for Medicare & Medicaid Services.
Stakeholder meetings—
In general— Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall convene a series of meetings to obtain input from appropriate stakeholders to facilitate discussion and shared learning about the leading practices for improving Medicaid program integrity, with respect to coverage of nonemergency transportation to medically necessary services.
Topics— The meetings convened under subparagraph (A) shall—
focus on ongoing challenges to Medicaid program integrity as well as leading practices to address such challenges; and
address specific challenges raised by stakeholders involved in coverage under the Medicaid program of nonemergency transportation to covered services, including unique considerations for specific groups of Medicaid beneficiaries meriting particular attention, such as American Indians and tribal land issues or accommodations for individuals with disabilities.
Stakeholders— Stakeholders described in subparagraph (A) shall include individuals from State Medicaid programs, brokers for nonemergency transportation to medically necessary services that meet the criteria described in section 1902(a)(70)(B) of the Social Security Act (42 U.S.C. 1396a(a)(70)(B)), providers (including transportation network companies), Medicaid patient advocates, and such other individuals specified by the Secretary.
Guidance review— Not later than 24 months after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall assess guidance issued to States by the Centers for Medicare & Medicaid Services relating to Federal requirements for nonemergency transportation to medically necessary services under the Medicaid program under title XIX of the Social Security Act and update such guidance as necessary to ensure States have appropriate and current guidance in designing and administering coverage under the Medicaid program of nonemergency transportation to medically necessary services.
Nemt transportation provider and driver requirements—
by striking “and” at the end of paragraph (85);
by striking the period at the end of paragraph (86) and inserting “; and”; and
by inserting after paragraph (86) the following new paragraph:
“(87) provide for a mechanism, which may include attestation, that ensures that, with respect to any provider (including a transportation network company) or individual driver of nonemergency transportation to medically necessary services receiving payments under such plan (but excluding any public transit authority), at a minimum—
“(A) each such provider and individual driver is not excluded from participation in any Federal health care program (as defined in section 1128B(f)) and is not listed on the exclusion list of the Inspector General of the Department of Health and Human Services;
“(B) each such individual driver has a valid driver’s license;
“(C) each such provider has in place a process to address any violation of a State drug law; and
“(D) each such provider has in place a process to disclose to the State Medicaid program the driving history, including any traffic violations, of each such individual driver employed by such provider, including any traffic violations.”
Effective date—
In general— Except as provided in clause (ii), the amendments made by subparagraph (A) shall take effect on the date of the enactment of this Act and shall apply to services furnished on or after the date that is one year after the date of the enactment of this Act.
Exception— In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or waiver of such plan, that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.
Analysis of t–msis data— Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall analyze, and submit to Congress a report on, the nation-wide data set under the Transformed Medicaid Statistical Information System to identify recommendations relating to coverage under the Medicaid program under title XIX of the Social Security Act of nonemergency transportation to medically necessary services.
Consultation relating to nonemergency medical transportation— In the case of a State that exercises the option described in section 1902(a)(70) of the Social Security Act (42 U.S.C. 1396a(a)(7)), in establishing a non-emergency medical transportation brokerage program under such section, a State Medicaid agency may consult relevant stakeholders, including stakeholders representing patients, medical providers, Medicaid managed care organizations, brokers for non-emergency medical transportation, and transportation providers (including public transportation providers).
210. Promoting access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials
in subsection (a)—
in paragraph (29), by striking “and” at the end;
by redesignating paragraph (30) as paragraph (31); and
by inserting after paragraph (29) the following new paragraph:
“(30) subject to subsection (gg), routine patient costs for items and services furnished in connection with participation in a qualifying clinical trial (as defined in such subsection); and”
by adding at the end the following new subsection:
“(gg)
“(1) Routine patient costs—For purposes of subsection (a)(30), with respect to a State and an individual enrolled under the State plan (or a waiver of such plan) who participates in a qualifying clinical trial, routine patient costs—
“(A) include any item or service provided to the individual under the qualifying clinical trial, including—
“(i) any item or service provided to prevent, diagnose, monitor, or treat complications resulting from such participation, to the extent that the provision of such an item or service to the individual outside the course of such participation would otherwise be covered under the State plan or waiver; and
“(ii) any item or service required solely for the provision of the investigational item or service that is the subject of such trial, including the administration of such investigational item or service; and
“(B) does not include—
“(i) an item or service that is the investigational item or service that is—
“(I) the subject of the qualifying clinical trial; and
“(II) not otherwise covered outside of the clinical trial under the State plan or waiver; or
“(ii) an item or service that is—
“(I) provided to the individual solely to satisfy data collection and analysis needs for the qualifying clinical trial and is not used in the direct clinical management of the individual; and
“(II) not otherwise covered under the State plan or waiver.
“(2) Qualifying clinical trial defined
“(A) In general—For purposes of this subsection and subsection (a)(30), the term qualifying clinical trial means a clinical trial (in any clinical phase of development) that is conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition and is described in any of the following clauses:
“(i) The study or investigation is approved, conducted, or supported (which may include funding through in-kind contributions) by one or more of the following:
“(I) The National Institutes of Health.
“(II) The Centers for Disease Control and Prevention.
“(III) The Agency for Healthcare Research and Quality.
“(IV) The Centers for Medicare & Medicaid Services.
“(V) A cooperative group or center of any of the entities described in subclauses (I) through (IV) or the Department of Defense or the Department of Veterans Affairs.
“(VI) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.
“(VII) Any of the following if the conditions described in subparagraph (B) are met:
“(aa) The Department of Veterans Affairs.
“(bb) The Department of Defense.
“(cc) The Department of Energy.
“(ii) The clinical trial is conducted pursuant to an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or an exemption for a biological product undergoing investigation under section 351(a)(3) of the Public Health Service Act.
“(iii) The clinical trial is a drug trial that is exempt from being required to have an exemption described in clause (ii).
“(B) Conditions—For purposes of subparagraph (A)(i)(VII), the conditions described in this subparagraph, with respect to a clinical trial approved or funded by an entity described in such subparagraph (A)(i)(VII), are that the clinical trial has been reviewed and approved through a system of peer review that the Secretary determines—
“(i) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health; and
“(ii) assures unbiased review of the highest scientific standards by qualified individuals with no interest in the outcome of the review.
“(3) Coverage determination requirements—A determination with respect to coverage under subsection (a)(30) for an individual participating in a qualifying clinical trial—
“(A) shall be expedited and completed within 72 hours;
“(B) shall be made without limitation on the geographic location or network affiliation of the health care provider treating such individual or the principal investigator of the qualifying clinical trial;
“(C) shall be based on attestation regarding the appropriateness of the qualifying clinical trial by the health care provider and principal investigator described in subparagraph (B), which shall be made using a streamlined, uniform form developed for State use by the Secretary and that includes the option to reference information regarding the qualifying clinical trial that is publicly available on a website maintained by the Secretary, such as clinicaltrials.gov (or a successor website); and
“(D) shall not require submission of the protocols of the qualifying clinical trial, or any other documentation that may be proprietary or determined by the Secretary to be burdensome to provide.”
Requiring mandatory coverage under State plan— Section 1902(a)(10)(A) of such Act is amended, in the matter preceding clause (i), by striking “and (29)” and inserting “(29), and (30)”.
Inclusion in benchmark coverage— Section 1937(b)(5) of such Act is amended by inserting before the period at the end the following: “, and beginning January 1, 2022, coverage of routine patient costs for items and services furnished in connection with participation in a qualifying clinical trial (as defined in section 1905(gg))”.
Exemption of additional expenditures from payment limits for territories— Section 1108(g)(4) of the Social Security Act (42 U.S.C. 1308(g)(4)) is amended—
by striking “With respect to” and inserting the following:
“(A) In general—With respect to”
by adding at the end the following new subparagraph:
“(B) Additional exemption—Payments under section 1903 for medical assistance consisting of routine patient costs (as defined in section 1905(gg)(1)) shall not be taken into account in applying subsection (f).”
Effective date—
In general— The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2022.
Exception for State legislation— In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or waiver of such plan, that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.
III Human Services
301. Extension of TANF, child care entitlement to States, and related programs
Activities authorized by part A of title IV and section 1108(b) of the Social Security Act shall continue through September 30, 2021, in the manner authorized for fiscal year 2020, and out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated such sums as may be necessary for such purpose. Grants and payments may be made pursuant to this authority on a quarterly basis through the 4th quarter of fiscal year 2021 at the level provided for such activities for the corresponding quarter of fiscal year 2020.
302. Personal responsibility education extension
Section 513 of the Social Security Act (42 U.S.C. 713) is amended—
in subsection (a)—
in paragraph (1)—
in subparagraph (A)—
in the matter preceding clause (i), by striking “2020 and for the period beginning October 1, 2020, and ending December 18, 2020” and inserting “2023”; and
in clause (i), by striking “or period”;
in subparagraph (B)(i), by striking the 2nd sentence;
in subparagraph (C)(i)—
by striking “or the period described in subparagraph (A)”; and
by striking “or period”;
in paragraph (3)—
by striking “or the period described in paragraph (1)(A)”; and
by striking “or period”; and
in paragraph (4)—
by striking “2020 and for the period described in paragraph (1)(A)” and inserting “2023”;
by striking “2020 and for the period so described” and inserting “2023”; and
by striking “or the period so described”;
in subsection (c)—
in each of paragraphs (1) and (2), by striking “Subject to paragraph (3), from” and inserting “From”; and
by striking paragraph (3); and
in subsection (f), by striking “2020, 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” and inserting “2023”.
303. Sexual risk avoidance education extension
Section 510 of the Social Security Act (42 U.S.C. 710) is amended—
in subsection (a)—
in paragraph (1)—
in the matter preceding subparagraph (A)—
by striking “2020 and for the period beginning October 1, 2020, and ending December 18, 2020” and inserting “2023”; and
by striking “(or, with respect to such period, for fiscal year 2021)”; and
in subparagraph (A), by striking “or period” each place it appears;
in paragraph (2)—
in subparagraph (A)—
by striking “2020 and for the period beginning October 1, 2020, and ending December 18, 2020” and inserting “2023”; and
by striking “(or, with respect to such period, for fiscal year 2021)”; and
in subparagraph (B)(i), by striking “(or, with respect to the period described in subparagraph (A), for fiscal year 2021)”; and
in subsection (f)—
in paragraph (1), by striking “2020, 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” and inserting “2023”; and
in paragraph (2), by striking “2020, and for the period described in paragraph (1),” and inserting “2023,”.
304. Extension of support for current health professions opportunity grants
Out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated to the Secretary of Health and Human Services $3,600,000, which shall be available—
through the end of fiscal year 2021 for necessary administrative expenses to carry out grants made under section 2008(a) of the Social Security Act before the date of the enactment of this Act; and
through the end of fiscal year 2022 for research, evaluation, and reporting under such section, and for necessary administrative expenses to carry out these activities.
305. Extension of MaryLee Allen Promoting Safe and Stable Families Program and State court support
Extensions— Section 436 of the Social Security Act (42 U.S.C. 629f) is amended in each of subsections (a), (b)(4)(A), (b)(5), and (f)(10) by striking “2021” and inserting “2022”.
in subsection (a)—
in paragraph (2)—
in subparagraph (A), by inserting “in a timely and complete manner” before “, as set forth”; and
in subparagraph (C), by striking the semicolon and inserting “, including by training judges, attorneys, and other legal personnel.”; and
by striking paragraphs (3) and (4);
in subsection (b)—
by striking paragraph (2);
by striking all that precedes “be eligible to receive” and inserting the following:
“(b) Applications—In order to”
in the matter preceding paragraph (2)—
by moving the matter 2 ems to the left;
in subparagraph (A)—
by striking “(A) in the case of a grant for the purpose described in subsection (a)(3),” and inserting “(1)”; and
by inserting “use not less than 30 percent of grant funds to” before “collaborate”;
in subparagraph (B), by striking “(B) in the case of a grant for the purpose described in subsection (a)(4),” and inserting “(2)”; and
in subparagraph (C), by striking “(C) in the case of a grant for the purpose described in subsection (a),” and inserting “(3)”;
by striking subsection (c) and inserting the following:
“(c) Amount of grant
“(1) In general—From the amounts reserved under sections 436(b)(2) and 437(b)(2) for a fiscal year, each highest State court that has an application approved under this section for the fiscal year shall be entitled to payment of an amount equal to the sum of—
“(A) $255,000; and
“(B) the amount described in paragraph (2) with respect to the court and the fiscal year.
“(2) Amount described—The amount described in this paragraph with respect to a court and a fiscal year is the amount that bears the same ratio to the total of the amounts reserved under sections 436(b)(2) and 437(b)(2) for grants under this section for the fiscal year (after applying paragraphs (1)(A) and (3) of this subsection) as the number of individuals in the State in which the court is located who have not attained 21 years of age bears to the total number of such individuals in all States with a highest State court that has an approved application under this section for the fiscal year.
“(3) Indian tribes—From the amounts reserved under section 436(b)(2) for a fiscal year, the Secretary shall, before applying paragraph (1) of this subsection, allocate $1,000,000 for grants to be awarded on a competitive basis among the highest courts of Indian tribes or tribal consortia that—
“(A) are operating a program under part E, in accordance with section 479B;
“(B) are seeking to operate a program under part E and have received an implementation grant under section 476; or
“(C) have a court responsible for proceedings related to foster care or adoption.”
in subsection (d), by striking “2017 through 2021” and inserting “2018 through 2022”.
Effective date— The amendments made by this section shall take effect on October 1, 2021.
IV Health Offsets
401. Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program
in subsection (b)—
in paragraph (2)(A), by inserting “or subsection (f)(2), as applicable” before the period at the end;
in paragraph (3), in the matter preceding subparagraph (A), by inserting “or subsection (f)(2), as applicable,” before “determined by”; and
in paragraph (6)(A), in the matter preceding clause (i), by inserting “or subsection (f)(2), as applicable,” before “determined by”; and
in subsection (f)—
by striking “For requirements” and inserting the following:
“(1) In general—For requirements”
by adding at the end the following new paragraph:
“(2) Manufacturers without a rebate agreement under title XIX
“(A) In general—If the manufacturer of a drug or biological described in subparagraph (C), (E), or (G) of section 1842(o)(1) or in section 1881(b)(14)(B) that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection (b) of section 1927, for calendar quarters beginning on January 1, 2022, such manufacturer shall report to the Secretary the information described in subsection (b)(3)(A)(iii) of such section 1927 with respect to such drug or biological in a time and manner specified by the Secretary. For purposes of applying this paragraph, a drug or biological described in the previous sentence includes items, services, supplies, and products that are payable under this part as a drug or biological.
“(B) Audit—Information reported under subparagraph (A) is subject to audit by the Inspector General of the Department of Health and Human Services.
“(C) Verification—The Secretary may survey wholesalers and manufacturers that directly distribute drugs or biologicals described in subparagraph (A), when necessary, to verify manufacturer prices and manufacturer’s average sales prices (including wholesale acquisition cost) if required to make payment reported under subparagraph (A). The Secretary may impose a civil monetary penalty in an amount not to exceed $100,000 on a wholesaler, manufacturer, or direct seller, if the wholesaler, manufacturer, or direct seller of such a drug or biological refuses a request for information about charges or prices by the Secretary in connection with a survey under this subparagraph or knowingly provides false information. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
“(D) Confidentiality—Notwithstanding any other provision of law, information disclosed by manufacturers or wholesalers under this paragraph (other than the wholesale acquisition cost for purposes of carrying out this section) is confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs or biologicals by such manufacturer or wholesaler, except—
“(i) as the Secretary determines to be necessary to carry out this section (including the determination and implementation of the payment amount), or to carry out section 1847B;
“(ii) to permit the Comptroller General of the United States to review the information provided;
“(iii) to permit the Director of the Congressional Budget Office to review the information provided;
“(iv) to permit the Medicare Payment Advisory Commission to review the information provided; and
“(v) to permit the Medicaid and CHIP Payment and Access Commission to review the information provided.”
in subsection (d)(4)—
in subparagraph (A), by striking “In general” and inserting “Misrepresentation”;
in subparagraph (B), by striking “subparagraph (B)” and inserting “subparagraph (A), (B), or (C)”;
by redesignating subparagraph (B) as subparagraph (E); and
by inserting after subparagraph (A) the following new subparagraphs:
“(B) Failure to provide timely information—If the Secretary determines that a manufacturer described in subsection (f)(2) has failed to report on information described in section 1927(b)(3)(A)(iii) with respect to a drug or biological in accordance with such subsection, the Secretary shall apply a civil money penalty in an amount of $10,000 for each day the manufacturer has failed to report such information and such amount shall be paid to the Treasury.
“(C) False information—Any manufacturer required to submit information under subsection (f)(2) that knowingly provides false information is subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalties are in addition to other penalties as may be prescribed by law.
“(D) Increasing oversight and enforcement—For calendar quarters beginning on or after January 1, 2022, section 1927(b)(3)(C)(iv) shall be applied as if—
“(i) each reference to “under this subparagraph and subsection (c)(4)(B)(ii)(III)” were a reference to “under this subparagraph, subsection (c)(4)(B)(ii)(III), and subparagraphs (A), (B), and (C) of section 1847A(d)(4)”; and
“(ii) the reference to “activities related to the oversight and enforcement of this section and agreements under this section” were a reference to “activities related to the oversight and enforcement of this section and under subsection (f)(2) of section 1847A and subparagraphs (A), (B), and (C) of section 1847A(d)(4) and, if applicable, agreements under this section”.”
in subsection (c)(6)(A), by striking the period at the end and inserting “, except that, for purposes of subsection (f)(2), the Secretary may, if the Secretary determines appropriate, exclude repackagers of a drug or biological from such term.”.
Manufacturers with a rebate agreement—
In general— Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding at the end the following new sentence: “For purposes of applying clause (iii), for calendar quarters beginning on or after January 1, 2022, a drug or biological described in the flush matter following such clause includes items, services, supplies, and products that are payable under part B of title XVIII as a drug or biological.”.
Technical amendment— Section 1927(b)(3)(A)(iii) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended by striking “section 1881(b)(13)(A)(ii)” and inserting “section 1881(b)(14)(B)”.
Report— Not later than January 1, 2023, the Inspector General of the Department of Health and Human Services shall assess and submit to Congress a report on the accuracy of average sales price information submitted by manufacturers under section 1847A of the Social Security Act (42 U.S.C. 1395w–3a), including the extent to which manufacturers provide false information, misclassify drug products, or misreport information. Such report shall include any recommendations on how to improve the accuracy of such information.
402. Extended months of coverage of immunosuppressive drugs for kidney transplant patients and other renal dialysis provisions
Medicare entitlement to immunosuppressive drugs for kidney transplant recipients—
In general— Section 226A(b)(2) of the Social Security Act (42 U.S.C. 426–1(b)(2)) is amended by inserting “(except for eligibility for enrollment under part B solely for purposes of coverage of immunosuppressive drugs described in section 1861(s)(2)(J))” before “, with the thirty-sixth month”.
Individuals eligible only for coverage of immunosuppressive drugs—
by striking “Every” and inserting “(a) In general.—Every”; and
by adding at the end the following new subsection:
“(b) Individuals eligible for immunosuppressive drug coverage
“(1) In general—Except as provided under paragraph (2), every individual whose entitlement to insurance benefits under part A ends (whether before, on, or after January 1, 2023) by reason of section 226A(b)(2) is eligible to enroll or to be deemed to have enrolled in the medical insurance program established by this part solely for purposes of coverage of immunosuppressive drugs in accordance with section 1837(n).
“(2) Exception if other coverage is available
“(A) In general—An individual described in paragraph (1) shall not be eligible for enrollment in the program for purposes of coverage described in such paragraph with respect to any period in which the individual, as determined in accordance with subparagraph (B)—
“(i) is enrolled in a group health plan or group or individual health insurance coverage, as such terms are defined in section 2791 of the Public Health Service Act;
“(ii) is enrolled for coverage under the TRICARE for Life program under section 1086(d) of title 10, United States Code;
“(iii) is enrolled under a State plan (or waiver of such plan) under title XIX and is eligible to receive benefits for immunosuppressive drugs described in this subsection under such plan (or such waiver);
“(iv) is enrolled under a State child health plan (or waiver of such plan) under title XXI and is eligible to receive benefits for such drugs under such plan (or such waiver); or
“(v)
“(I) is enrolled in the patient enrollment system of the Department of Veterans Affairs established and operated under section 1705 of title 38, United States Code;
“(II) is not required to enroll under section 1705 of such title to receive immunosuppressive drugs described in this subsection; or
“(III) is otherwise eligible under a provision of title 38, United States Code, other than section 1710 of such title to receive immunosuppressive drugs described in this subsection.
“(B) Eligibility determinations
“(i) In general—The Secretary, in coordination with the Commissioner of Social Security, shall establish a process for determining whether an individual described in paragraph (1) who is to be enrolled or deemed to be enrolled in the medical insurance program described in such paragraph meets the requirements for such enrollment under this subsection, including the requirement that the individual not be enrolled in other coverage as described in subparagraph (A).
“(ii) Attestation regarding other coverage—The process established under clause (i) shall include, at a minimum, a requirement that—
“(I) the individual provide to the Commissioner an attestation that the individual is not enrolled and does not expect to enroll in such other coverage; and
“(II) the individual notify the Commissioner within 60 days of enrollment in such other coverage.”
Conforming amendment—
In general— Sections 1837, 1838, and 1839 of the Social Security Act (42 U.S.C. 1395p, 42 U.S.C. 1395q, 42 U.S.C. 1395r) are each amended by striking “1836” and inserting “1836(a)” each place it appears.
Additional amendment— Section 1837(j)(1) of such Act (42 U.S.C. 1395p(j)(1)) is amended by striking “1836(1)” and inserting “1836(a)(1)”.
Enrollment for individuals only eligible for coverage of immunosuppressive drugs— Section 1837 of the Social Security Act (42 U.S.C. 1395p), as amended by section 120, is amended by adding at the end the following new subsection:
“(n)
“(1) Any individual who is eligible for coverage of immunosuppressive drugs under section 1836(b) may enroll or be deemed to have enrolled only in such manner and form as may be prescribed by regulations, and only during an enrollment period described in this subsection.
“(2) An individual described in paragraph (1) whose entitlement for hospital insurance benefits under part A ends by reason of section 226A(b)(2) prior to January 1, 2023, may enroll beginning on October 1, 2022, or the day on which the individual first satisfies section 1836(b), whichever is later.
“(3) An individual described in paragraph (1) whose entitlement for hospital insurance benefits under part A ends by reason of section 226A(b)(2) on or after January 1, 2023, shall be deemed to have enrolled in the medical insurance program established by this part for purposes of coverage of immunosuppressive drugs.
“(4) The Secretary shall establish a process under which an individual described in paragraph (1) whose other coverage described in section 1836(b)(2)(A), or coverage under this part (including the medical insurance program established under this part for purposes of coverage of immunosuppressive drugs), is terminated voluntarily or involuntary may enroll or reenroll, if applicable, in the medical insurance program established under this part for purposes of coverage of immunosuppressive drugs.”
Coverage period for individuals only eligible for coverage of immunosuppressive drugs—
In general— Section 1838 of the Social Security Act (42 U.S.C. 1395q), as amended by section 120, is further amended by adding at the end the following new subsection:
“(h) In the case of an individual described in section 1836(b)(1), the following rules shall apply:
“(1) In the case of such an individual who is deemed to have enrolled in part B for coverage of immunosuppressive drugs under section 1837(n)(3), such individual’s coverage period shall begin on the first day of the month in which the individual first satisfies section 1836(b).
“(2) In the case of such an individual who enrolls (or reenrolls, if applicable) in part B for coverage of immunosuppressive drugs under paragraph (2) or (4) of section 1837(n), such individual’s coverage period shall begin on January 1, 2023, or the month following the month in which the individual so enrolls (or reenrolls), whichever is later.
“(3) The provisions of subsections (b) and (d) shall apply with respect to an individual described in paragraph (1) or (2).
“(4) In addition to the reasons for termination under subsection (b), the coverage period of an individual described in paragraph (1) or (2) shall end when the individual becomes entitled to benefits under this title under subsection (a) or (b) of section 226, or under section 226A, or is no longer eligible for such coverage as a result of the application of section 1836(b)(2).
“(5) The Secretary may conduct public education activities to raise awareness of the availability of more comprehensive, individual health insurance coverage (as defined in section 2791 of the Public Health Service Act) for individuals eligible under section 1836(b) to enroll or to be deemed enrolled in the medical insurance program established under this part for purposes of coverage of immunosuppressive drugs.”
Conforming amendments— Section 1838(b) of the Social Security Act (42 U.S.C. 1395q(b)) is amended, in the matter following paragraph (2), by inserting “or section 1837(n)(3)” after “section 1837(f)” each place it appears.
Premiums for individuals only eligible for coverage of immunosuppressive drugs—
In general— Section 1839 of the Social Security Act (42 U.S.C. 1395r), as amended by section 120, is further amended—
in subsection (b), by adding at the end the following new sentence: “No increase in the premium shall be effected for individuals who are enrolled pursuant to section 1836(b) for coverage only of immunosuppressive drugs.”; and
by adding at the end the following new subsection:
“(j) Determination of premium for individuals only eligible for coverage of immunosuppressive drugs—The Secretary shall, during September of each year (beginning with 2022), determine and promulgate a monthly premium rate for the succeeding calendar year for individuals enrolled only for the purpose of coverage of immunosuppressive drugs under section 1836(b). Such premium shall be equal to 15 percent of the monthly actuarial rate for enrollees age 65 and over (as would be determined in accordance with subsection (a)(1) if the reference to “one-half” in such subsection were a reference to “100 percent”) for that succeeding calendar year. The monthly premium of each individual enrolled for coverage of immunosuppressive drugs under section 1836(b) for each month shall be the amount promulgated in this subsection. In the case of such individual not otherwise enrolled under this part, such premium shall be in lieu of any other monthly premium applicable under this section. Such amount shall be adjusted in accordance with subsections (c), (f), and (i), but shall not be adjusted under subsection (b).”
Special rule for application of hold harmless provisions to transitioning individuals— Section 1839(f) of the Social Security Act (42 U.S.C. 1395r(f)) is amended by adding at the end the following new sentence: “Any increase in the premium for an individual who was enrolled under section 1836(b) attributable to such individual otherwise enrolling under this part shall not be taken into account in applying this subsection.”.
Special rule for application of premium subsidy reduction provisions— Section 1839(i)(3)(A)(ii)(II) of the Social Security Act (42 U.S.C. 1395r(i)(3)(A)(ii)(II)) is amended by inserting “(or, with respect to an individual enrolled under section 1836(b) and not otherwise enrolled under this part, 0 times the amount of such increase)” after “in the year”.
Government contribution— Section 1844(a) of the Social Security Act (42 U.S.C. 1395w(a)) is amended—
in paragraph (3), by striking the period at the end and inserting “; plus”;
by inserting after paragraph (3) the following new paragraph:
“(4) a Government contribution equal to the estimated aggregate reduction in premiums payable under part B that results from establishing the premium at 15 percent of the actuarial rate (as would be determined in accordance with section 1839(a)(1) if the reference to “one-half” in such section were a reference to “100 percent”) under section 1839(j) instead of 25 percent of such rate (as so determined) for individuals enrolled only for the purpose of coverage of immunosuppressive drugs under section 1836(b).”
by adding the following sentence at the end of the flush matter following paragraph (4), as added by paragraph (2) of this subsection:
Ensuring coverage under the Medicare savings program—
In general— Section 1905(p)(1)(A) of the Social Security Act (42 U.S.C. 1396d(p)(1)(A)) is amended by inserting “or who is enrolled under part B for the purpose of coverage of immunosuppressive drugs under section 1836(b)” after “under section 1818A)”.
Conforming amendments— Section 1902(a)(10)(E) of the Social Security Act (42 U.S.C. 1396a(a)(10)(E)) is amended in each of clauses (iii) and (iv) by inserting “(including such individuals enrolled under section 1836(b))” after “section 1905(p)(1)”.
Part D— Section 1860D–1(a)(3)(A) of the Social Security Act (42 U.S.C. 1395w–101(a)(3)(A)) is amended by inserting “(but not including an individual enrolled solely for coverage of immunosuppressive drugs under section 1836(b))” before the period at the end.
GAO study and report—
Study— The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall conduct a study on the implementation of coverage of immunosuppressive drugs for kidney transplant patients under the Medicare program pursuant to the provisions of, and amendments made by, this section.
Report— Not later than January 1, 2025, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1), together with recommendations as the Comptroller General determines appropriate.
403. Permitting direct payment to physician assistants under Medicare
Section 1842(b)(6)(C) of the Social Security Act (42 U.S.C. 1395u(b)(6)(C)) is amended, in the matter preceding clause (i), by inserting “for such services furnished before January 1, 2022,” after “1861(s)(2)(K),”.
404. Adjusting calculation of hospice cap amount under Medicare
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C. 1395f(i)(2)(B)) is amended—
in clause (ii), by striking “2025” and inserting “2030”; and
in clause (iii), by striking “2025” and inserting “2030”.
405. Special rule for determination of ASP in cases of certain noncovered self-administered drug products
Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended by redesignating subsection (g) as subsection (h) and by inserting after subsection (f) the following:
“(g) Payment adjustment for certain drugs for which there is a self-administered NDC
“(1) OIG studies—The Inspector General of the Department of Health and Human Services shall conduct periodic studies to identify National Drug Codes for drug or biological products that are self-administered for which payment may not be made under this part because such products are not covered pursuant to section 1861(s)(2) and which the Inspector General determines (based on the same or similar methodologies to the methodologies used in the final recommendation followup report of the Inspector General described in paragraph (3) or in the November 2017 final report of the Inspector General entitled “Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries”) should be excluded from the determination of the payment amount under this section.
“(2) Payment adjustment—If the Inspector General identifies a National Drug Code for a drug or biological product under paragraph (1), the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this paragraph) and the Secretary shall, to the extent the Secretary deems appropriate, apply as the amount of payment under this section for the applicable billing and payment code the lesser of—
“(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such product so identified under paragraph (1) were excluded from such determination; or
“(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection.
“(3) Application to certain identified products—In the case of a National Drug Code for a drug or biological product that is self-administered for which payment is not made under this part because such product is not covered pursuant to section 1861(s)(2) that was identified by the Inspector General of the Department of Health and Human Services in the final recommendation followup report of the Inspector General published July 2020, entitled Loophole in Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds of Millions of Dollars, beginning July 1, 2021, the amount of payment under this section for the applicable billing and payment code shall be the lesser of—
“(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such drug or biological products so identified were excluded from such determination; or
“(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection.”
406. Medicaid Improvement Fund
Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C 1396w–1(b)(3)(A)), as amended by section 1303 of the Further Continuing Appropriations Act, 2021, and Other Extensions Act, is amended by striking “ $3,464,000,000” and inserting “ $0”.
407. Establishing hospice program survey and enforcement procedures under the Medicare program
Survey and enforcement procedures—
In general— Part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.) is amended by adding at the end the following new section:
“1822. Hospice program survey and enforcement procedures
“(a) Surveys
“(1) Frequency—Any entity that is certified as a hospice program (as defined in section 1861(dd)(2)) shall be subject to a standard survey by an appropriate State or local survey agency, or an approved accreditation agency, as determined by the Secretary, not less frequently than once every 36 months.
“(2) Public transparency of survey and certification information
“(A) Submission of information to the Secretary
“(i) In general—Each State or local survey agency, and each national accreditation body with respect to which the Secretary has made a finding under section 1865(a) respecting the accreditation of a hospice program by such body, shall submit, in a form and manner, and at a time, specified by the Secretary for purposes of this paragraph, information respecting any survey or certification made with respect to a hospice program by such survey agency or body, as applicable. Such information shall include any inspection report made by such survey agency or body with respect to such survey or certification, any enforcement actions taken as a result of such survey or certification, and any other information determined appropriate by the Secretary.
“(ii) Required inclusion of specified form—With respect to a survey under this subsection carried out by a national accreditation body described in clause (i) on or after October 1, 2021, information described in such clause shall include Form CMS-2567 (or a successor form), along with such additional information determined appropriate by such body.
“(B) Public disclosure of information—Beginning not later than October 1, 2022, the Secretary shall publish the information submitted under subparagraph (A) on the public website of the Centers for Medicare & Medicaid Services in a manner that is prominent, easily accessible, readily understandable, and searchable. The Secretary shall provide for the timely update of such information so published.
“(3) Consistency of surveys—Each State and the Secretary shall implement programs to measure and reduce inconsistency in the application of survey results among surveyors.
“(4) Survey teams
“(A) In general—In the case of a survey conducted under this subsection on or after October 1, 2021, by more than 1 individual, such survey shall be conducted by a multidisciplinary team of professionals (including a registered professional nurse).
“(B) Prohibition of conflicts of interest—Beginning October 1, 2021, a State may not use as a member of a survey team under this subsection an individual who is serving (or has served within the previous 2 years) as a member of the staff of, or as a consultant to, the program surveyed respecting compliance with the requirements of section 1861(dd) or who has a personal or familial financial interest in the program being surveyed.
“(C) Training—The Secretary shall provide, not later than October 1, 2021, for the comprehensive training of State and Federal surveyors, and any surveyor employed by a national accreditation body described in paragraph (2)(A)(i), in the conduct of surveys under this subsection, including training with respect to the review of written plans for providing hospice care (as described in section 1814(a)(7)(B)). No individual shall serve as a member of a survey team with respect to a survey conducted on or after such date unless the individual has successfully completed a training and testing program in survey and certification techniques that has been approved by the Secretary.
“(5) Funding—The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 to the Centers for Medicare & Medicaid Services Program Management Account, of $10,000,000 for each fiscal year (beginning with fiscal year 2022) for purposes of carrying out this subsection and subsection (b). Sums so transferred shall remain available until expended. Any transfer pursuant to this paragraph shall be in addition to any transfer pursuant to section 3(a)(2) of the Improving Medicare Post-Acute Care Transformation Act of 2014.
“(b) Special focus program
“(1) In general—The Secretary shall conduct a special focus program for enforcement of requirements for hospice programs that the Secretary has identified as having substantially failed to meet applicable requirements of this Act.
“(2) Periodic surveys—Under such special focus program, the Secretary shall conduct surveys of each hospice program in the special focus program not less than once every 6 months.
“(c) Enforcement
“(1) Situations involving immediate jeopardy—If the Secretary determines on the basis of a standard survey or otherwise that a hospice program that is certified for participation under this title is no longer in compliance with the requirements specified in section 1861(dd) and determines that the deficiencies involved immediately jeopardize the health and safety of the individuals to whom the program furnishes items and services, the Secretary shall take immediate action to ensure the removal of the jeopardy and correction of the deficiencies or terminate the certification of the program, and may provide, in addition, for 1 or more of the other remedies described in paragraph (5)(B).
“(2) Situations not involving immediate jeopardy—If the Secretary determines on the basis of a standard survey or otherwise that a hospice program that is certified for participation under this title is no longer in compliance with the requirements specified in section 1861(dd) and determines that the deficiencies involved do not immediately jeopardize the health and safety of the individuals to whom the program furnishes items and services, the Secretary may (for a period not to exceed 6 months) impose remedies developed pursuant to paragraph (5)(A), in lieu of terminating the certification of the program. If, after such a period of remedies, the program is still no longer in compliance with such requirements, the Secretary shall terminate the certification of the program.
“(3) Penalty for previous noncompliance—If the Secretary determines that a hospice program that is certified for participation under this title is in compliance with the requirements specified in section 1861(dd) but, as of a previous period, did not meet such requirements, the Secretary may provide for a civil money penalty under paragraph (5)(B)(i) for the days in which the Secretary finds that the program was not in compliance with such requirements.
“(4) Option to continue payments for noncompliant hospice programs—The Secretary may continue payments under this title with respect to a hospice program not in compliance with the requirements specified in section 1861(dd) over a period of not longer than 6 months, if—
“(A) the State or local survey agency finds that it is more appropriate to take alternative action to assure compliance of the program with such requirements than to terminate the certification of the program;
“(B) the program has submitted a plan and timetable for corrective action to the Secretary for approval and the Secretary approves the plan of corrective action; and
“(C) the program agrees to repay to the Federal Government payments received under this title during such period if the corrective action is not taken in accordance with the approved plan and timetable.
“(5) Remedies
“(A) Development
“(i) In general—Not later than October 1, 2022, the Secretary shall develop and implement—
“(I) a range of remedies to apply to hospice programs under the conditions described in paragraphs (1) through (4); and
“(II) appropriate procedures for appealing determinations relating to the imposition of such remedies.
“(ii) Conditions of imposition of remedies—Not later than October 1, 2022, the Secretary shall develop and implement specific procedures with respect to the conditions under which each of the remedies developed under clause (i) is to be applied, including the amount of any fines and the severity of each of these remedies. Such procedures shall be designed so as to minimize the time between identification of deficiencies and imposition of these remedies and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies.
“(B) Specified remedies—The remedies specified in this subparagraph are the following:
“(i) Civil money penalties in an amount not to exceed $10,000 for each day of noncompliance by a hospice program with the requirements specified in section 1861(dd).
“(ii) Suspension of all or part of the payments to which a hospice program would otherwise be entitled under this title with respect to items and services furnished by a hospice program on or after the date on which the Secretary determines that remedies should be imposed pursuant to paragraphs (1) and (2).
“(iii) The appointment of temporary management to oversee the operation of the hospice program and to protect and assure the health and safety of the individuals under the care of the program while improvements are made in order to bring the program into compliance with all such requirements.
“(C) Procedures
“(i) Civil money penalties
“(I) In general—Subject to subclause (II), the provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
“(II) Retention of amounts for hospice program improvements—The Secretary may provide that any portion of civil money penalties collected under this subsection may be used to support activities that benefit individuals receiving hospice care, including education and training programs to ensure hospice program compliance with the requirements of section 1861(dd).
“(ii) Suspension of payment—A finding to suspend payment under subparagraph (B)(ii) shall terminate when the Secretary finds that the program is in substantial compliance with all requirements of section 1861(dd).
“(iii) Temporary management—The temporary management under subparagraph (B)(iii) shall not be terminated until the Secretary has determined that the program has the management capability to ensure continued compliance with all the requirements referred to in such subparagraph.
“(D) Relationship to other remedies—The remedies developed under subparagraph (A) are in addition to sanctions otherwise available under State or Federal law and shall not be construed as limiting other remedies, including any remedy available to an individual at common law.”
Availability of hospice accreditation surveys— Section 1865(b) of the Social Security Act (42 U.S.C. 1395bb(b)) is amended by inserting “or, beginning on the date of the enactment of the Consolidated Appropriations Act, 2021, a hospice program” after “home health agency”.
State provision of hospice program information—
In general— Section 1864(a) of the Social Security Act (42 U.S.C. 1395aa(a)) is amended in the sixth sentence—
by inserting “and hospice programs” after “information on home health agencies”;
by inserting “or the hospice program” after “the home health agency”;
by inserting “or the hospice program” after “with respect to the agency”; and
by inserting “and hospice programs” after “with respect to home health agencies”.
Effective date— The amendments made by subparagraph (A) shall apply with respect to agreements entered into on or after, or in effect as of, the date that is 1 year after the date of the enactment of this Act.
Conforming amendments—
Definition of a hospice program— Section 1861(dd)(4) of the Social Security Act (42 U.S.C. 1395x(dd)(4)) is amended by striking subparagraph (C).
Continuation of funding— Section 3(a)(2) of the Improving Medicare Post-Acute Care Transformation Act of 2014 is amended by inserting “and section 1822(a)(1) of such Act,” after “as added by paragraph (1),”.
Increasing payment reductions for failure to meet quality data reporting requirements— Section 1814(i)(5)(A)(i) of the Social Security Act (42 U.S.C. 1395f(i)(5)(A)(i)) is amended by inserting “(or, for fiscal year 2024 and each subsequent fiscal year, 4 percentage points)” before the period.
Report— Not later than 36 months after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report containing an analysis of the effects of the amendments made by subsection (a), including the frequency of application of remedies specified in section 1822(c)(5)(B) of the Social Security Act (as added by such subsection), on access to, and quality of, care furnished by hospice programs under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.).
408. Medicare Improvement Fund
Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking “ $0” and inserting “ $165,000,000”.
V Miscellaneous
501. Implementation funding
For purposes of carrying out the provisions of, and the amendments made by, titles I, II, and IV, in addition to any funds otherwise made available, there are appropriated from amounts in the Treasury not otherwise appropriated, $37,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2021, to remain available until expended.