SEC. 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)) is amended by striking “ January 1, 2020” and inserting “ May 23, 2020”.
Division N — Health and Human Services Extenders
DIVISION N Health and Human Services Extenders
TITLE I Health and Human Services Extenders
Subtitle A Medicare Provisions
SEC. 102. Extension of Funding for Quality Measure Endorsement, Input, and Selection.
in the first sentence, by striking “ $1,665,000 for the period beginning on October 1, 2019, and ending on December 20, 2019” and inserting “ $4,830,000 for the period beginning on October 1, 2019, and ending on May 22, 2020”; and
in the third sentence, by striking “ December 20, 2019,” and inserting “ May 22, 2020”.
Effective Date.— The amendments made by subsection (a) shall take effect as if included in the enactment of the Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 (Public Law 116–69).
SEC. 103. Extension of Funding Outreach and Assistance for Low-Income Programs.
Additional Funding for 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 the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Public Law 116–59), and section 1402 of the Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 (Public Law 116–69), is amended—
in clause (x), by striking “ and” at the end;
in clause (xi), by striking the period at the end and inserting “ ; and”; and
by inserting after clause (xi) the following new clause:
“(xii) for the period beginning on December 21, 2019, and ending on May 22, 2020, of $5,485,000.”
Additional Funding for Area Agencies on Aging.— Subsection (b)(1)(B) of such section 119, as so amended, is amended—
in clause (x), by striking “ and” at the end;
in clause (xi), by striking the period at the end and inserting “ ; and”; and
by inserting after clause (xi) the following new clause:
“(xii) for the period beginning on December 21, 2019, and ending on May 22, 2020, of $3,165,000.”
Additional Funding for Aging and Disability Resource Centers.— Subsection (c)(1)(B) of such section 119, as so amended, is amended—
in clause (x), by striking “ and” at the end;
in clause (xi), by striking the period at the end and inserting “ ; and”; and
by inserting after clause (xi) the following new clause:
“(xii) for the period beginning on December 21, 2019, and ending on May 22, 2020, of $2,110,000.”
Additional Funding for 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 “ and” at the end;
in clause (xi), by striking the period at the end and inserting “ ; and”; and
by inserting after clause (xi) the following new clause:
“(xii) for the period beginning on December 21, 2019, and ending on May 22, 2020, of $5,063,000.”
SEC. 104. Extension of Appropriations to the Patient-Centered Outcomes Research Trust Fund; Extension of Certain Health Insurance Fees.
In General.— Section 9511 of the Internal Revenue Code of 1986 is amended—
in subsection (b)—
in paragraph (1)—
by inserting after subparagraph (E) the following new subparagraph:
“(F) For each of fiscal years 2020 through 2029—
“(i) an amount equivalent to the net revenues received in the Treasury from the fees imposed under subchapter B of chapter 34 (relating to fees on health insurance and self-insured plans) for such fiscal year; and
“(ii) the applicable amount (as defined in paragraph (4)) for the fiscal year.”
; and
by striking “ and (E)(ii)” in the last sentence and inserting “ (E)(ii), and (F)(ii)”; and
by adding at the end the following new paragraph:
“(4) Applicable amount defined.—In paragraph (1)(F)(ii), the term ‘applicable amount’ means—
“(A) for fiscal year 2020, $275,500,000;
“(B) for fiscal year 2021, $285,000,000;
“(C) for fiscal year 2022, $293,500,000;
“(D) for fiscal year 2023, $311,500,000;
“(E) for fiscal year 2024, $320,000,000;
“(F) for fiscal year 2025, $338,000,000;
“(G) for fiscal year 2026, $355,500,000;
“(H) for fiscal year 2027, $363,500,000;
“(I) for fiscal year 2028, $381,000,000; and
“(J) for fiscal year 2029, $399,000,000.”
in subsection (d)(2)(A), by striking “ 2019” and inserting “ 2029”; and
in subsection (f), by striking “ December 20, 2019” and inserting “ September 30, 2029”.
Health Insurance Policies.— Section 4375(e) of the Internal Revenue Code of 1986 is amended by striking “ 2019” and inserting “ 2029”.
Self-insured Health Plans.— Section 4376(e) of the Internal Revenue Code of 1986 is amended by striking “ 2019” and inserting “ 2029”.
Identification of Research Priorities.— Subsection (d)(1)(A) of section 1181 of the Social Security Act (42 U.S.C. 1320e) is amended by adding at the end the following: “ Such national priorities shall include research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments.”.
Consideration of Full Range of Outcomes Data.— Subsection (d)(2) of such section 1181 is amended by adding at the end the following subparagraph:
“(F) Consideration of full range of outcomes data.—Research shall be designed, as appropriate, to take into account and capture the full range of clinical and patient-centered outcomes relevant to, and that meet the needs of, patients, clinicians, purchasers, and policy-makers in making informed health decisions. In addition to the relative health outcomes and clinical effectiveness, clinical and patient-centered outcomes shall include the potential burdens and economic impacts of the utilization of medical treatments, items, and services on different stakeholders and decision-makers respectively. These potential burdens and economic impacts include medical out-of-pocket costs, including health plan benefit and formulary design, non-medical costs to the patient and family, including caregiving, effects on future costs of care, workplace productivity and absenteeism, and healthcare utilization.”
Board Composition.— Subsection (f) of such section 1181 is amended—
in paragraph (1)—
in subparagraph (C)—
in the matter preceding clause (i)—
by striking “ Seventeen” and inserting “ At least nineteen, but no more than twenty-one”; and
by striking “ , not later than 6 months after the date of enactment of this section,”; and
in clause (iii), by striking “ 3” and inserting “ at least 3, but no more than 5”; and
in paragraph (3)—
in the first sentence—
by striking the “ the members” and inserting “ members”; and
by inserting the following before the period at the end: “ to the extent necessary to preserve the evenly staggered terms of the Board.”; and
by inserting the following after the first sentence: “ Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed.”.
Methodology Committee Appointments.— Such section 1181 is amended—
in subsection (d)(6)(B), by striking “ Comptroller General of the United States” and inserting “ Board”; and
in subsection (h)(4)—
in subparagraph (A)(ii), by striking “ Comptroller General” and inserting “ Board”; and
in the first sentence of subparagraph (B), by striking “ and of the Government Accountability Office”.
Reports by the Comptroller General of the United States.— Subsection (g)(2)(A) of such section 1181 is amended—
by striking clause (iv) and inserting the following:
“(iv) Not less frequently than every 5 years, the overall effectiveness of activities conducted under this section and the dissemination, training, and capacity building activities conducted under section 937 of the Public Health Service Act. Such review shall include the following:
“(I) A description of those activities and the financial commitments related to research, training, data capacity building, and dissemination and uptake of research findings.
“(II) The extent to which the Institute and the Agency for Healthcare Research and Quality have collaborated with stakeholders, including provider and payer organizations, to facilitate the dissemination and uptake of research findings.
“(III) An analysis of available data and performance metrics, such as the estimated public availability and dissemination of research findings and uptake and utilization of research findings in clinical guidelines and decision support tools, on the extent to which such research findings are used by health care decision-makers, the effect of the dissemination of such findings on changes in medical practice and reducing practice variation and disparities in health care, and the effect of the research conducted and disseminated on innovation and the health care economy of the United States.”
; and
by adding at the end the following new clause:
“(vi) Not less frequently than every 5 years, any barriers that researchers funded by the Institute have encountered in conducting studies or clinical trials, including challenges covering the cost of any medical treatments, services, and items described in subsection (a)(2)(B) for purposes of the research study.”
SEC. 105. Laboratory Access for Beneficiaries.
Amendments Relating to Reporting Requirements With Respect to Clinical Diagnostic Laboratory Tests.—
Revised reporting period for reporting of private sector payment rates for establishment of medicare payment rates.— Section 1834A(a) of the Social Security Act (42 U.S.C. 1395m–1(a)) is amended—
in paragraph (1)—
by striking “ Beginning January 1, 2016” and inserting the following:
“(A) General reporting requirements.—Subject to subparagraph (B), beginning January 1, 2016”
in subparagraph (A), as added by subparagraph (A) of this paragraph, by inserting “ (referred to in this subsection as the ‘reporting period’)” after “ at a time specified by the Secretary”; and
by adding at the end the following:
“(B) Revised reporting period.—In the case of reporting with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the Secretary shall revise the reporting period under subparagraph (A) such that—
“(i) no reporting is required during the period beginning January 1, 2020, and ending December 31, 2020;
“(ii) reporting is required during the period beginning January 1, 2021, and ending March 31, 2021; and
“(iii) reporting is required every three years after the period described in clause (ii).”
; and
in paragraph (4)—
by striking “ In this section” and inserting the following:
“(A) In general.—Subject to subparagraph (B), in this section”
; and
by adding at the end the following:
“(B) Exception.—In the case of the reporting period described in paragraph (1)(B)(ii) with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the term ‘data collection period’ means the period beginning January 1, 2019, and ending June 30, 2019.”
Corrections relating to phase-in of reductions from private payor rate implementation.— Section 1834A(b)(3) of the Social Security Act (42 U.S.C. 1395m–1(b)(3)) is amended—
in subparagraph (A), by striking “ through 2022” and inserting “ through 2023”; and
in subparagraph (B)—
in clause (i), by striking “ through 2019” and inserting “ through 2020”; and
in clause (ii), by striking “ 2020 through 2022” and inserting “ 2021 through 2023”.
Study and Report by MedPAC.—
In general.— The Medicare Payment Advisory Commission (in this subsection referred to as the “Commission”) shall conduct a study to review the methodology the Administrator of the Centers for Medicare & Medicaid Services has implemented for the private payor rate-based clinical laboratory fee schedule under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
Scope of study.— In carrying out the study described in paragraph (1), the Commission shall consider the following:
How best to implement the least burdensome data collection process required under section 1834A(a)(1) of such Act (42 U.S.C. 1395m–1(a)(1)) that would—
result in a representative and statistically valid data sample of private market rates from all laboratory market segments, including hospital outreach laboratories, physician office laboratories, and independent laboratories; and
consider the variability of private payor payment rates across market segments.
Appropriate statistical methods for estimating rates that are representative of the market.
Report to congress.— Not later than 18 months after the date of the enactment of this Act, the Commission shall submit to the Administrator, the Committee on Finance of the Senate, and the Committees on Ways and Means and Energy and Commerce of the House of Representatives a report that includes—
conclusions about the methodology described in paragraph (1); and
any recommendations the Commission deems appropriate.
SEC. 106. Exclusion of Complex Rehabilitative Manual Wheelchairs from Medicare Competitive Acquisition Program; Non-Application of Medicare Fee-schedule Adjustments for Certain Wheelchair Accessories and Cushions.
Exclusion of Complex Rehabilitative Manual Wheelchairs From Competitive Acquisition Program.— Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)(A)) is amended—
by inserting “ , complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes)” after “ group 3 or higher”; and
by striking “ such wheelchairs” and inserting “ such complex rehabilitative power wheelchairs, complex rehabilitative manual wheelchairs, and certain manual wheelchairs”.
Non-application of Medicare Fee Schedule Adjustments for Wheelchair Accessories and Seat and Back Cushions When Furnished in Connection With Complex Rehabilitative Manual Wheelchairs.—
In general.— Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, during the period beginning on January 1, 2020, and ending on June 30, 2021, use information on the payment determined under the competitive acquisition programs under section 1847 of the Social Security Act (42 U.S.C. 1395w–3) to adjust the payment amount that would otherwise be recognized under section 1834(a)(1)(B)(ii) of such Act (42 U.S.C. 1395m(a)(1)(B)(ii)) for wheelchair accessories (including seating systems) and seat and back cushions when furnished in connection with complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes).
Implementation.— Notwithstanding any other provision of law, the Secretary may implement this subsection by program instruction or otherwise.
SEC. 107. Extending Pass-Through Status for Certain Drugs under Part B of the Medicare Program.
in subparagraph (E)(i), by striking “ 2018” and inserting “ 2018 or 2020”; and
by adding at the end the following new subparagraph:
“(J) Additional pass-through extension and special payment adjustment rule for certain diagnostic radiopharmaceuticals.—In the case of a drug or biological furnished in the context of a clinical study on diagnostic imaging tests approved under a coverage with evidence development determination whose period of pass-through status under this paragraph concluded on December 31, 2018, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2019, the Secretary shall—
“(i) extend such pass-through status for such drug or biological for the 9-month period beginning on January 1, 2020;
“(ii) remove, during such period, the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged; and
“(iii) not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (ii).”
Implementation.— Notwithstanding any other provision of law, the Secretary of Health and Human Service may implement the amendments made by subsection (a) by program instruction or otherwise.
SEC. 108. Hematopoietic Stem Cell Acquisition Payments.
Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is amended—
in subsection (a)(4), in the second sentence, by inserting “ for cost reporting periods beginning on or after October 1, 2020, costs related to hematopoietic stem cell acquisition for the purpose of an allogeneic hematopoietic stem cell transplant (as described in subsection (d)(5)(M)),” after “ October 1, 1987),”;
in subsection (d)—
in paragraph (4)(C)(iii)—
by inserting “ or payments under paragraph (5)(M) (beginning with fiscal year 2021)” after “ fiscal year 1991)”; and
by inserting “ or payments under paragraph (5)(M)” before the period at the end; and
in paragraph (5), by adding at the end the following new subparagraph:
“(M)
(i) For cost reporting periods beginning on or after October 1, 2020, in the case of a subsection (d) hospital that furnishes an allogeneic hematopoietic stem cell transplant to an individual during such a period, payment to such hospital for hematopoietic stem cell acquisition shall be made on a reasonable cost basis. The items included in such hematopoietic stem cell acquisition shall be specified by the Secretary through rulemaking.
“(ii) For purposes of this subparagraph, the term ‘allogeneic hematopoietic stem cell transplant’ means, with respect to an individual, the intravenous infusion of hematopoietic cells derived from bone marrow, peripheral blood stem cells, or cord blood, but not including embryonic stem cells, of a donor to an individual that are or may be used to restore hematopoietic function in such individual having an inherited or acquired deficiency or defect.”
Subtitle B Medicaid Provisions
SEC. 201. Extension of Community Mental Health Services Demonstration Program.
Section 223(d)(3) of the Protecting Access to Medicare Act of 2014 (42 U.S.C. 1396a note) is amended by striking “ December 20, 2019” and inserting “ May 22, 2020”.
SEC. 202. Medicaid Funding for the Territories.
in paragraph (2)—
in the matter preceding subparagraph (A), by striking “ subject to and section 1323(a)(2) of the Patient Protection and Affordable Care Act paragraphs (3) and (5)” and inserting “ subject to section 1323(a)(2) of the Patient Protection and Affordable Care Act and paragraphs (3) and (5)”;
in subparagraph (A)—
by striking “ Puerto Rico shall not exceed the sum of” and inserting
“(i) except as provided in clause (ii), the sum of”
by striking “ $100,000;” and inserting “ $100,000; and”; and
by adding at the end the following new clause:
“(ii) for each of fiscal years 2020 through 2021, the amount specified in paragraph (6) for each such fiscal year;”
in subparagraph (B)—
by striking “ the Virgin Islands shall not exceed the sum of” and inserting
“(i) except as provided in clause (ii), the sum of”
by striking “ $10,000;” and inserting “ $10,000; and”; and
by adding at the end the following new clause:
“(ii) for each of fiscal years 2020 through 2021, $126,000,000;”
in subparagraph (C)—
by striking “ Guam shall not exceed the sum of” and inserting
“(i) except as provided in clause (ii), the sum of”
by striking “ $10,000;” and inserting “ $10,000; and”; and
by adding at the end the following new clause:
“(ii) for each of fiscal years 2020 through 2021, $127,000,000;”
in subparagraph (D)—
by striking “ the Northern Mariana Islands shall not exceed the sum of” and inserting
“(i) except as provided in clause (ii), the sum of”
; and
by adding at the end the following new clause:
“(ii) for each of fiscal years 2020 through 2021, $60,000,000; and”
in subparagraph (E)—
by striking “ American Samoa shall not exceed the sum of” and inserting
“(i) except as provided in clause (ii), the sum of”
by striking “ $10,000.” and inserting “ $10,000; and”; and
by adding at the end the following new clause:
“(ii) for each of fiscal years 2020 through 2021, $84,000,000.”
; and
by adding at the end the following flush sentence: “For each fiscal year after fiscal year 2021, the total amount certified for Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa under subsection (f) and this subsection for the fiscal year shall be determined as if the preceding subparagraphs were applied to each of fiscal years 2020 through 2021 without regard to clause (ii) of each such subparagraph.”; and
by adding at the end the following new paragraphs:
“(6) Application to puerto rico for fiscal years 2020 through 2021.—
“(A) In general.—Subject to subparagraph (B), the amount specified in this paragraph is—
“(i) for fiscal year 2020, $2,623,188,000; and
“(ii) for fiscal year 2021, $2,719,072,000.
“(B) Additional increase for puerto rico.—
“(i) In general.—For each of fiscal years 2020 through 2021, the amount specified in this paragraph for the fiscal year shall be equal to the amount specified for such fiscal year under subparagraph (A) increased by $200,000,000 if the Secretary certifies that, with respect to such fiscal year, Puerto Rico’s State plan under title XIX (or a waiver of such plan) establishes a reimbursement floor, implemented through a directed payment arrangement plan, for physician services that are covered under the Medicare part B fee schedule in the Puerto Rico locality established under section 1848(b) that is not less than 70 percent of the payment that would apply to such services if they were furnished under part B of title XVIII during such fiscal year.
“(ii) Application to managed care.—In certifying whether Puerto Rico has established a reimbursement floor under a directed payment arrangement plan that satisfies the requirements of clause (i)—
“(I) for fiscal year 2020, the Secretary shall apply such requirements to payments for physician services under a managed care contract entered into or renewed after the date of enactment of this paragraph and disregard payments for physician services under any managed care contract that was entered into prior to such date; and
“(II) for each of fiscal years 2020 through 2021—
“(aa) the Secretary shall disregard payments made under sub-capitated arrangements for services such as primary care case management; and
“(bb) if the reimbursement floor for physician services applicable under a managed care contract satisfies the requirements of clause (i) for the fiscal year in which the contract is entered into or renewed, such reimbursement floor shall be deemed to satisfy such requirements for the subsequent fiscal year.
“(7) Puerto rico program integrity requirements.—
“(A) In general.—
“(i) Program integrity lead.—Not later than 6 months after the date of enactment of this paragraph, the agency responsible for the administration of Puerto Rico’s Medicaid program under title XIX shall designate an officer (other than the director of such agency) to serve as the Program Integrity Lead for such program.
“(ii) PERM requirement.—Not later than 18 months after the date of enactment of this paragraph, Puerto Rico shall publish a plan, developed by Puerto Rico in coordination with the Administrator of the Centers for Medicare & Medicaid Services and approved by the Administrator, for how Puerto Rico will develop measures to satisfy the payment error rate measurement (PERM) requirements under subpart Q of part 431 of title 42, Code of Federal Regulations (or any successor regulation).
“(iii) Contracting reform.—Not later than 12 months after the date of enactment of this paragraph, Puerto Rico shall publish a contracting reform plan to combat fraudulent, wasteful, or abusive contracts under Puerto Rico’s Medicaid program under title XIX that includes—
“(I) metrics for evaluating the success of the plan; and
“(II) a schedule for publicly releasing status reports on the plan.
“(iv) MEQC.—Not later than 18 months after the date of enactment of this paragraph, Puerto Rico shall publish a plan, developed by Puerto Rico in coordination with the Administrator of the Centers for Medicare & Medicaid Services and approved by the Administrator, for how Puerto Rico will comply with the Medicaid eligibility quality control (MEQC) requirements of subpart P of part 431 of title 42, Code of Federal Regulations (or any successor regulation).
“(B) FMAP reduction for failure to meet additional requirements.—
“(i) In general.—For each fiscal quarter during the period beginning on January 1, 2020, and ending on September 30, 2021:
“(I) For every clause under subparagraph (A) with respect to which Puerto Rico does not fully satisfy the requirements described in the clause (including requirements imposed under the terms of a plan described in the clause) in the fiscal quarter, the Federal medical assistance percentage applicable to Puerto Rico under section 1905(ff) shall be reduced by the number of percentage points determined for the clause and fiscal quarter under subclause (II).
“(II) The number of percentage points determined under this subclause with respect to a clause under subparagraph (A) and a fiscal quarter shall be the number of percentage points (not to exceed 2.5 percentage points) equal to—
“(aa) 0.25 percentage points; multiplied by
“(bb) the total number of consecutive fiscal quarters for which Puerto Rico has not fully satisfied the requirements described in such clause.
“(ii) Exception for extenuating circumstances or reasonable progress.—For purposes of clause (i), Puerto Rico shall be deemed to have fully satisfied the requirements of a clause under subparagraph (A) (including requirements imposed under the terms of a plan described in the clause) for a fiscal quarter if—
“(I) the Secretary approves an application from Puerto Rico describing extenuating circumstances that prevented Puerto Rico from fully satisfying the requirements of the clause; or
“(II) in the case of a requirement imposed under the terms of a plan described in a clause under subparagraph (A), Puerto Rico has made objectively reasonable progress towards satisfying such terms and has submitted a timely request for an exception to the imposition of a penalty to the Secretary.
“(8) Program integrity lead requirement for the virgin islands, guam, the northern mariana islands, and american samoa.—
“(A) Program integrity lead requirement.—Not later than October 1, 2020, the agency responsible for the administration of the Medicaid program under title XIX of each territory specified in subparagraph (C) shall designate an officer (other than the director of such agency) to serve as the Program Integrity Lead for such program.
“(B) FMAP reduction.—For each fiscal quarter during fiscal year 2021, if the territory fails to satisfy the requirement of subparagraph (A) for the fiscal quarter, the Federal medical assistance percentage applicable to the territory under section 1905(ff) for such fiscal quarter shall be reduced by the number of percentage points (not to exceed 5 percentage points) equal to—
“(i) 0.25 percentage points; multiplied by
“(ii) the total number of fiscal quarters during the fiscal year in which the territory failed to satisfy such requirement.
“(C) Scope.—This paragraph shall apply to the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa.”
Treatment of Funding Under Enhanced Allotment Program.— Section 1935(e) of the Social Security Act (42 U.S.C. 1396u–5(e)) is amended—
in paragraph (1)(B), by striking “ if the State” and inserting “ subject to paragraph (4), if the State”;
by redesignating paragraph (4) as paragraph (5); and
by inserting after paragraph (3) the following new paragraph:
“(4) Treatment of funding for certain fiscal years.—Notwithstanding paragraph (1)(B), in the case that Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa establishes and submits to the Secretary a plan described in paragraph (2) with respect to any of fiscal years 2020 through 2021, the amount specified for such a year in paragraph (3) for Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa, as the case may be, shall be taken into account in applying, as applicable, subparagraph (A)(ii), (B)(ii), (C)(ii), (D)(ii), or (E)(ii) of section 1108(g)(2) for such year.”
Increased FMAP.— Subsection (ff) of section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended to read as follows:
“(ff) Temporary Increase in FMAP for Territories for Certain Fiscal Years.—Notwithstanding subsection (b) or (z)(2)—
“(1) for the period beginning October 1, 2019, and ending December 20, 2019, the Federal medical assistance percentage for Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa shall be equal to 100 percent;
“(2) subject to section 1108(g)(7)(C), for the period beginning December 21, 2019, and ending September 30, 2021, the Federal medical assistance percentage for Puerto Rico shall be equal to 76 percent; and
“(3) subject to section 1108(g)(8)(B), for the period beginning December 21, 2019, and ending September 30, 2021, the Federal medical assistance percentage for the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa shall be equal to 83 percent.”
Annual Report.— Section 1108(g) of the Social Security Act (42 U.S.C. 1308(g)), as amended by subsection (a), is further amended by adding at the end the following new paragraph:
“(9) Annual report.—
“(A) In general.—Not later than the date that is 30 days after the end of each fiscal year (beginning with fiscal year 2020 and ending with fiscal year 2021), in the case that a specified territory receives a Medicaid cap increase, or an increase in the Federal medical assistance percentage for such territory under section 1905(ff), for such fiscal year, such territory shall submit to the Chair and Ranking Member of the Committee on Energy and Commerce of the House of Representatives and the Chair and Ranking Member of the Committee on Finance of the Senate a report, employing the most up-to-date information available, that describes how such territory has used such Medicaid cap increase, or such increase in the Federal medical assistance percentage, as applicable, to increase access to health care under the State Medicaid plan of such territory under title XIX (or a waiver of such plan). Such report may include—
“(i) the extent to which such territory has, with respect to such plan (or waiver)—
“(I) increased payments to health care providers;
“(II) increased covered benefits;
“(III) expanded health care provider networks; or
“(IV) improved in any other manner the carrying out of such plan (or waiver); and
“(ii) any other information as determined necessary by such territory.
“(B) Definitions.—In this paragraph:
“(i) Medicaid cap increase.—The term ‘Medicaid cap increase’ means, with respect to a specified territory and fiscal year, any increase in the amounts otherwise determined under this subsection for such territory for such fiscal year by reason of the amendments made by section 202 of division N of the Further Consolidated Appropriations Act, 2020.
“(ii) Specified territory.—The term ‘specified territory’ means Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa.”
Application of Certain Data Reporting and Program Integrity Requirements to Northern Mariana Islands, American Samoa, and Guam.—
In general.— Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection:
“(qq) Application of Certain Data Reporting and Program Integrity Requirements to Northern Mariana Islands, American Samoa, and Guam.—
“(1) In general.—Not later than October 1, 2021, the Northern Mariana Islands, American Samoa, and Guam shall—
“(A) demonstrate progress in implementing methods, satisfactory to the Secretary, for the collection and reporting of reliable data to the Transformed Medicaid Statistical Information System (T–MSIS) (or a successor system); and
“(B) demonstrate progress in establishing a State medicaid fraud control unit described in section 1903(q).
“(2) Determination of progress.—For purposes of paragraph (1), the Secretary shall deem that a territory described in such paragraph has demonstrated satisfactory progress in implementing methods for the collection and reporting of reliable data or establishing a State medicaid fraud control unit if the territory has made a good faith effort to implement such methods or establish such a unit, given the circumstances of the territory.”
by striking “ or the requirement” and inserting “ , the requirement”; and
by inserting before the period at the end the following: “ , or the requirement under subsection (qq)(1) (relating to data reporting)”.
Reevaluation of waivers of medicaid fraud control unit requirement.—
In general.— Not later than the date that is 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall reevaluate any waiver approved (and in effect as of the date of enactment of this Act) for Guam, the Northern Mariana Islands, or American Samoa under subsection (a)(61) or subsection (j) of section 1902 of the Social Security Act (42 U.S.C.1396a) with respect to the requirement to establish a State medicaid fraud control unit (as described in section 1903(q) of such Act (42 U.S.C. 1396b(q))).
Rule of construction.— Nothing in this paragraph shall be construed as requiring the Secretary of Health and Human Services to terminate or refuse to extend a waiver described in subparagraph (A).
Additional Program Integrity Requirements.—
Definitions.— In this subsection:
Inspector general.— The term “Inspector General” means the Inspector General of the Department of Health and Human Services.
Puerto rico’s medicaid program.— The term “Puerto Rico’s Medicaid program” means, collectively, Puerto Rico’s State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) and any waiver of such plan.
Report on contracting oversight and approval.— Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall issue, and submit to the Chair and Ranking Member of the Committee on Energy and Commerce of the House of Representatives and the Chair and Ranking Member of the Committee on Finance of the Senate, a report on contracting oversight and approval with respect to Puerto Rico’s State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of such plan). Such report shall—
examine—
the process used by Puerto Rico to evaluate bids and award contracts under such plan (or waiver);
which contracts are not subject to competitive bidding or requests for proposals under such plan (or waiver); and
oversight by the Centers for Medicare & Medicaid Services of contracts awarded under such plan (or waiver); and
include any recommendations for Congress, the Secretary of Health and Human Services, or Puerto Rico relating to changes that the Comptroller General determines necessary to improve the program integrity of such plan (or waiver).
Audits of managed care payments.— Not later than the date that is 1 year after the date of enactment of this Act, the Inspector General shall develop and submit to Congress—
a report identifying payments made under Puerto Rico’s Medicaid program to managed care organizations that the Inspector General determines to be at high risk for waste, fraud, or abuse; and
a plan for auditing and investigating such payments.
System for tracking federal funding provided to puerto rico; medicaid and chip scorecard reporting.— Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended by subsection (e), is further amended by adding at the end the following new subsection:
“(rr) Program Integrity Requirements for Puerto Rico.—
“(1) System for tracking federal medicaid funding provided to puerto rico.—
“(A) In general.—Puerto Rico shall establish and maintain a system, which may include the use of a quarterly Form CMS–64, for tracking any amounts paid by the Federal Government to Puerto Rico with respect to the State plan of Puerto Rico (or a waiver of such plan). Under such system, Puerto Rico shall ensure that information is available, with respect to each quarter in a fiscal year (beginning with the first quarter beginning on or after the date that is 1 year after the date of the enactment of this subsection), on the following:
“(i) In the case of a quarter other than the first quarter of such fiscal year—
“(I) the total amount expended by Puerto Rico during any previous quarter of such fiscal year under the State plan of Puerto Rico (or a waiver of such plan); and
“(II) a description of how such amount was so expended.
“(ii) The total amount that Puerto Rico expects to expend during the quarter under the State plan of Puerto Rico (or a waiver of such plan), and a description of how Puerto Rico expects to expend such amount.
“(B) Report to cms.—For each quarter with respect to which Puerto Rico is required under subparagraph (A) to ensure that information described in such subparagraph is available, Puerto Rico shall submit to the Administrator of the Centers for Medicare & Medicaid Services a report on such information for such quarter, which may include the submission of a quarterly Form CMS–37.
“(2) Submission of documentation on contracts upon request.—Puerto Rico shall, upon request, submit to the Administrator of the Centers for Medicare & Medicaid Services all documentation requested with respect to contracts awarded under the State plan of Puerto Rico (or a waiver of such plan).
“(3) Reporting on medicaid and chip scorecard measures.—Beginning 12 months after the date of enactment of this subsection, Puerto Rico shall begin to report to the Administrator of the Centers for Medicare & Medicaid Services on selected measures included in the Medicaid and CHIP Scorecard developed by the Centers for Medicare & Medicaid Services.”
Appropriation.— Out of any funds in the Treasury not otherwise appropriated, there is appropriated to the Secretary of Health and Human Services $5,000,000 for each of fiscal years 2020 through 2021 to carry out this subsection.
SEC. 203. Delay of Dsh Reductions.
Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C. 1396r–4(f)(7)(A)) is amended by striking “ December 21, 2019” each place it appears and inserting “ May 23, 2020”.
SEC. 204. Extension of Spousal Impoverishment Protections.
In General.— Section 2404 of Public Law 111–148 (42 U.S.C. 1396r–5 note) is amended by striking “ December 31, 2019” and inserting “ May 22, 2020”.
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).
SEC. 205. Extension of the Money Follows the Person Rebalancing Demonstration Program.
Section 6071(h) of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a note) is amended—
in paragraph (1)—
in subparagraph (E), by striking “ and” after the semicolon;
in subparagraph (F), by striking the period at the end and inserting “ ; and”; and
by adding at the end the following:
“(G) subject to paragraph (3), $176,000,000 for the period beginning on January 1, 2020, and ending on May 22, 2020.”
; and
in paragraph (3)—
in the paragraph header, by striking “ for fy 2019”; and
by striking “ paragraph (1)(F)” and inserting “ subparagraphs (F) and (G) of paragraph (1)”.
Subtitle C Human Services and Other Health Programs
SEC. 301. Extension of Demonstration Projects to Address Health Professions Workforce Needs.
Activities authorized by section 2008 of the Social Security Act shall continue through May 22, 2020, in the manner authorized for fiscal year 2019, 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 through the date so specified at the pro rata portion of the total amount authorized for such activities in fiscal year 2019.
SEC. 302. Extension of the Temporary Assistance for Needy Families Program and Related Programs.
Activities authorized by part A of title IV and section 1108(b) of the Social Security Act shall continue through May 22, 2020, in the manner authorized for fiscal year 2019, 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.
SEC. 303. Extension of Sexual Risk Avoidance Education Program.
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 “ December 20, 2019” and inserting “ May 22, 2020”;
in paragraph (2)(A), by striking “ December 20, 2019” and inserting “ May 22, 2020”; and
in subsection (f)(1), by striking “ $16,643,836 for the period beginning October 1, 2019, and ending December 20, 2019” and inserting “ $48,287,671 for the period beginning October 1, 2019, and ending May 22, 2020”.
SEC. 304. Extension of Personal Responsibility Education Program.
Section 513 of the Social Security Act (42 U.S.C. 713) is amended—
in subsection (a)(1)—
in subparagraph (A), in the matter preceding clause (i), by striking “ December 20, 2019” and inserting “ May 22, 2020”;
in subparagraph (B)(i), by striking by striking “ December 20, 2019” and inserting “ May 22, 2020”; and
in subsection (f), by striking “ $16,643,836 for the period beginning October 1, 2019, and ending December 20, 2019” and inserting “ $48,287,671 for the period beginning October 1, 2019, and ending May 22, 2020”.
Subtitle D Public Health Provisions
SEC. 401. Extension for Community Health Centers, the National Health Service Corps, and Teaching Health Centers That Operate Gme Programs.
Community Health Centers.— Section 10503(b)(1)(F) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended by—
striking “ $887,671,223” and inserting “ $2,575,342,466”; and
striking “ December 20, 2019” and inserting “ May 22, 2020”.
National Health Service Corps.— Section 10503(b)(2)(G) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(2)(G)) is amended—
by striking “ $68,794,521” and inserting “ $199,589,041”; and
by striking “ December 20, 2019” and inserting “ May 22, 2020”.
Teaching Health Centers That Operate Graduate Medical Education Programs.— Section 340H(g)(1) of the Public Health Service Act (42 U.S.C. 256h(g)(1)) is amended—
by striking “ $28,072,603” and inserting “ $81,445,205”; and
by striking “ December 20, 2019” and inserting “ May 22, 2020”.
Application of Provisions.— Amounts appropriated pursuant to the amendments made by this section for the period beginning on October 1, 2019, and ending on May 22, 2020, shall be subject to the requirements contained in Public Law 115–245 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254 through 256).
Conforming Amendment.— Paragraph (4) of section 3014(h) of title 18, United States Code, as amended by section 1101(e) of division B of Public Law 116–69, is amended by striking “ section 1101(d) of division B of the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, and section 1101(d) of the Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019” and inserting “ , and section 401(d) of division N of the Further Consolidated Appropriations Act, 2020”.
SEC. 402. Diabetes Programs.
Type I.— Section 330B(b)(2)(D) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)(D)) is amended—
by striking “ $33,287,671” and inserting “ $96,575,342”; and
by striking “ December 20, 2019” and inserting “ May 22, 2020”.
Indians.— Section 330C(c)(2)(D) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)(D)) is amended—
by striking “ $33,287,671” and inserting “ $96,575,342”; and
by striking “ December 20, 2019” and inserting “ May 22, 2020”.
SEC. 403. Poison Center Network Enhancement.
National Toll-free Number.— Section 1271 of the Public Health Service Act (42 U.S.C. 300d–71) is amended—
in the section heading, by inserting before the period the following: “ and other communication capabilities”; and
by striking subsection (a) and inserting the following:
“(a) In General.—The Secretary—
“(1) shall provide coordination and assistance to poison control centers for the establishment and maintenance of a nationwide toll-free phone number, to be used to access such centers; and
“(2) may provide coordination and assistance to poison control centers and consult with professional organizations for the establishment, implementation, and maintenance of other communication technologies to be used to access such centers.”
by redesignating subsection (b) as subsection (c);
by inserting after subsection (a) the following:
“(b) Routing Contacts With Poison Control Centers.—Not later than 18 months after the date of enactment of this subsection, the Secretary shall coordinate with the Chairman of the Federal Communications Commission, to the extent technically and economically feasible, to ensure that communications with the national toll-free number are routed to the appropriate poison control center based on the physical location of the contact rather than the area code of the contact device.”
; and
in subsection (c), as so redesignated—
by striking “ 2015 through 2019” and inserting “ 2020 through 2024”; and
by striking “ maintenance of the nationwide toll free phone number under subsection (a)” and inserting “ establishment, implementation, and maintenance activities carried out under subsections (a) and (b)”.
Nationwide Media Campaign.— Section 1272 of the Public Health Service Act (42 U.S.C. 300d–72) is amended—
in the section heading, by striking “ nationwide media campaign to promote” and inserting “ promoting”;
in subsection (a)—
by inserting “ and support outreach to” after “ educate”;
by striking “ poison prevention” and inserting “ poisoning and toxic exposure prevention”; and
by striking “ established under” and inserting “ and other available communication technologies established, implemented, or maintained under”;
in subsection (b)—
in the matter preceding paragraph (1), by striking “ nationwide poison prevention” and inserting “ nationwide poisoning and toxic exposure prevention”; and
in paragraph (1), by striking “ poison prevention and poison control center” and inserting “ poisoning and toxic exposure prevention awareness materials, applicable public health emergency preparedness and response information, and poison control center” after “ distribution of”; and
by striking subsection (c);
by redesignating subsection (d) as subsection (c); and
in subsection (c) (as so redesignated), by striking “ 2015 through 2019” and inserting “ 2020 through 2024”.
Maintenance of Program.— Section 1273 of the Public Health Service Act (42 U.S.C. 300d–73) is amended—
in subsection (a), by inserting “ and toxic exposures” after “ poisonings”; and
in subsection (b)—
in paragraph (1)—
by striking “ for poison” and inserting “ for poisoning and toxic exposure”; and
by striking “ and preparedness” and inserting “ preparedness and response”;
in paragraph (3)—
by striking “ United States and” and inserting “ United States,”; and
by inserting before the semicolon the following: “ , and other government agencies as determined to be appropriate and nonduplicative by the Secretary”; and
in paragraph (8), by striking “ calls” and inserting “ contacts”;
in subsection (d) , by striking paragraph (3) and inserting the following:
“(3) Limitation.—
“(A) In general.—The sum of the number of years for a waiver under paragraph (1) and a renewal under paragraph (2) may not exceed 5 years.
“(B) Public health emergency.—Notwithstanding any previous waivers, in the case of a poison control center whose accreditation is affected by a public health emergency declared pursuant to section 319, the Secretary may, as the circumstances of the emergency reasonably require, provide a waiver under paragraph (1) or a renewal under paragraph (2), not to exceed 2 years. The Secretary may require quarterly reports and other information related to such a waiver or renewal under this paragraph.”
by striking subsection (f) and inserting the following:
“(f) Maintenance of Effort.—With respect to activities for which a grant is awarded under this section, the Secretary may require that poison control centers agree to maintain the expenditures of the center for such activities at a level that is not less than the level of expenditures maintained by the center for the fiscal year preceding the fiscal year for which the grant is received.”
In subsection (g), by striking “ 2015 through 2019” and inserting “ 2020 through 2024”; and
by adding at the end the following:
“(h) Biennial Report to Congress.—Not later than 2 years after the date of enactment of this subsection, and every 2 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives a report concerning the operations of, and trends identified by, the Poison Control Network. Such report shall include—
“(1) descriptions of the activities carried out pursuant to sections 1271, 1272, and 1273, and the alignment of such activities with the purposes provided under subsection (a);
“(2) a description of trends in volume of contacts to poison control centers;
“(3) a description of trends in poisonings and toxic exposures reported to poison control centers, as applicable and appropriate;
“(4) an assessment of the impact of the public awareness campaign, including any geographic variations;
“(5) a description of barriers, if any, preventing poison control centers from achieving the purposes and programs under this section and sections 1271 and 1272;
“(6) a description of the standards for accreditation described in subsection (c), including any variations in those standards, and any efforts to create and maintain consistent standards across organizations that accredit poison control centers; and
“(7) the number of and reason for any waivers provided under subsection (d).”
SEC. 404. Kay Hagan Tick Act.
Short Title.— This section may be cited as the “Kay Hagan Tick Act”.
Combating Vector-borne Diseases.— Title III of the Public Health Service Act is amended by inserting after section 317T (42 U.S.C. 247b–22) the following:
“SEC. 317U. NATIONAL STRATEGY AND REGIONAL CENTERS OF EXCELLENCE IN VECTOR-BORNE DISEASES.
“(a) In General.—The Secretary shall—
“(1)
(A) ensure the development and implementation of a national strategy to address vector-borne diseases, including tick-borne diseases, that—
“(i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
“(ii) identifies strategic goals to address such diseases and appropriate benchmarks to measure progress toward achieving such goals; and
“(B) update such strategy, as appropriate; and
“(2) coordinate programs and activities, including related to data collection, research, and the development of diagnostics, treatments, vaccines, and other related activities, to address vector-borne diseases, including tick-borne diseases, across the Department of Health and Human Services and with other Federal agencies or departments, as appropriate.
“(b) Consultation.—In carrying out subsection (a)(1), the Secretary shall consult with the Tick-Borne Disease Working Group established under section 2062 of the 21st Century Cures Act (42 U.S.C. 284s) and other individuals, as appropriate, such as—
“(1) epidemiologists with experience in vector-borne diseases;
“(2) representatives of patient advocacy and research organizations that focus on vector-borne diseases, including such organizations that have demonstrated experience in related research, public health, data collection, or patient access to care;
“(3) health information technology experts or other information management specialists;
“(4) clinicians, entomologists, vector management professionals, public health professionals, and others with expertise in vector-borne diseases; and
“(5) researchers, including researchers with experience conducting translational research.
“(c) Centers of Excellence.—The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention, shall award grants, contracts, or cooperative agreements to institutions of higher education for the establishment or continued support of regional centers of excellence in vector-borne diseases to address vector-borne diseases, including tick-borne diseases, by—
“(1) facilitating collaboration between academia and public health organizations for public health surveillance, prevention, and response activities related to vector-borne diseases, including tick-borne diseases;
“(2) providing training for public health entomologists and other health care professionals, as appropriate, to address vector-borne diseases, including tick-borne diseases;
“(3) conducting research to develop and validate prevention and control tools and methods, including evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease outbreaks; or
“(4) preparing for and responding to outbreaks of vector-borne diseases, including tick-borne diseases.
“(d) Eligibility.—To be eligible to receive a grant, contract, or cooperative agreement under subsection (c), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of how the entity will conduct the activities described in such subsection.
“(e) Reports.—
“(1) Program summary.—An entity receiving an award under subsection (c) shall, not later than one year after receiving such award, and annually thereafter, submit to the Secretary a summary of programs and activities funded under the award.
“(2) Progress report.—Not later than 4 years after the date of enactment of this section, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the progress made in addressing vector-borne diseases, including tick-borne diseases, through activities carried out under this section.
“(f) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2021 through 2025.”
Enhancing Capacity to Address Vector-borne Diseases.— Subtitle C of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:
“SEC. 2822. ENHANCED SUPPORT TO ASSIST HEALTH DEPARTMENTS IN ADDRESSING VECTOR-BORNE DISEASES.
“(a) In General.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may enter into cooperative agreements with health departments of States, political subdivisions of States, and Indian Tribes and Tribal organizations in areas at high risk of vector-borne diseases in order to increase capacity to identify, report, prevent, and respond to such diseases and related outbreaks.
“(b) Eligibility.—To be eligible to enter into a cooperative agreement under this section, an entity described in subsection (a) shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a plan that describes—
“(1) how the applicant proposes to develop or expand programs to address vector-borne disease risks, including through—
“(A) related training and workforce development;
“(B) programmatic efforts to improve capacity to identify, report, prevent, and respond to such disease and related outbreaks; and
“(C) other relevant activities identified by the Director of the Centers for Disease Control and Prevention, as appropriate;
“(2) the manner in which the applicant will coordinate with other Federal, Tribal, and State agencies and programs, as applicable, related to vector-borne diseases, as well as other relevant public and private organizations or agencies; and
“(3) the manner in which the applicant will evaluate the effectiveness of any program carried out under the cooperative agreement.
“(c) Authorization of Appropriations.—For the purposes of carrying out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years 2021 through 2025.”
Subtitle E Revenue Provisions
SEC. 501. Repeal of Medical Device Excise Tax.
In General.— Chapter 32 of the Internal Revenue Code of 1986 is amended by striking subchapter E.
Conforming Amendments.—
Subsection (a) of section 4221 of the Internal Revenue Code of 1986 is amended by striking the last sentence.
Paragraph (2) of section 6416(b) of such Code is amended by striking the last sentence.
Clerical Amendment.— The table of subchapters for chapter 32 of the Internal Revenue Code of 1986 is amended by striking the item relating to subchapter E.
Effective Date.— The amendments made by this section shall apply to sales after December 31, 2019.
SEC. 502. Repeal of Annual Fee on Health Insurance Providers.
SEC. 503. Repeal of Excise Tax on High Cost Employer-Sponsored Health Coverage.
In General.— Chapter 43 of the Internal Revenue Code of 1986 is amended by striking section 4980I.
Conforming Amendments.—
Section 6051 of such Code is amended—
by striking “ section 4980I(d)(1)” in subsection (a)(14) and inserting “ subsection (g)”, and
by adding at the end the following new subsection:
“(g) Applicable Employer-Sponsored Coverage.—For purposes of subsection (a)(14)—
“(1) In general.—The term ‘applicable employer-sponsored coverage’ means, with respect to any employee, coverage under any group health plan made available to the employee by an employer which is excludable from the employee’s gross income under section 106, or would be so excludable if it were employer-provided coverage (within the meaning of such section 106).
“(2) Exceptions.—The term ‘applicable employer-sponsored coverage’ shall not include—
“(A) any coverage (whether through insurance or otherwise) described in section 9832(c)(1) (other than subparagraph (G) thereof) or for long-term care,
“(B) any coverage under a separate policy, certificate, or contract of insurance which provides benefits substantially all of which are for treatment of the mouth (including any organ or structure within the mouth) or for treatment of the eye, or
“(C) any coverage described in section 9832(c)(3) the payment for which is not excludable from gross income and for which a deduction under section 162(l) is not allowable.
“(3) Coverage includes employee paid portion.—Coverage shall be treated as applicable employer-sponsored coverage without regard to whether the employer or employee pays for the coverage.
“(4) Governmental plans included.—Applicable employer-sponsored coverage shall include coverage under any group health plan established and maintained primarily for its civilian employees by the Government of the United States, by the government of any State or political subdivision thereof, or by any agency or instrumentality of any such government.”
Section 9831(d)(1) of such Code is amended by striking “ except as provided in section 4980I(f)(4)”.
The table of sections for chapter 43 of such Code is amended by striking the item relating to section 4980I.
Effective Date.— The amendments made by this section shall apply to taxable years beginning after December 31, 2019.
Subtitle F Miscellaneous Provisions
SEC. 602. Addressing Expiration of Child Welfare Demonstration Projects and Supporting Family First Implementation.
Short Title.— This section may be cited as the “Family First Transition Act”.
Evidence Standard Transition.—
Temporary suspension of requirement that at least 50 percent of a state’s reimbursement for prevention and family services and programs be for programs and services that meet the well-supported practice requirement.— With respect to quarters in fiscal years 2020 and 2021, section 474(a)(6)(A) of the Social Security Act (42 U.S.C. 674(a)(6)(A)) shall be applied without regard to clause (ii) of such section.
Supported practices temporarily treated as well-supported practices.— With respect to quarters in fiscal years 2022 and 2023, practices that meet the criteria specified for supported practices in section 471(e)(4)(C) of the Social Security Act (42 U.S.C. 671(e)(4)(C)) shall be considered well-supported practices for purposes of section 474(a)(6)(A)(ii) of such Act (42 U.S.C. 674(a)(6)(A)(ii)).
Enhanced Funding for Transition Activities.—
Transition funding.—
Appropriation.— Out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated to the Secretary of Health and Human Services (in this section referred to as the “Secretary”) to carry out this subsection $500,000,000 for fiscal year 2020, which shall remain available through fiscal year 2021.
Distribution of funds.—
In general.— The Secretary shall allot the amount appropriated by subparagraph (A) of this paragraph in accordance with section 423 of the Social Security Act (42 U.S.C. 623), and shall pay each State to which an allotment is so made, the total amount so allotted, subject to clause (ii) of this subparagraph.
Reservation of funds for indian tribes and tribal organizations.— Before applying clause (i) of this subparagraph, the Secretary shall reserve 3 percent of the amount appropriated by subparagraph (A) of this paragraph for allotment to the Indian tribes and tribal organizations with a plan approved under subpart 1 of part B of title IV of the Social Security Act, based on each tribe or tribal organization’s share of the total tribal child population among all such tribes and tribal organizations.
Funding certainty for states with expiring demonstration projects.—
In general.— Out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated to the Secretary, for payment to each State that was operating a demonstration project approved under section 1130 of the Social Security Act on September 30, 2019, for each fiscal year specified in subparagraph (B) of this paragraph, an amount equal to the amount (if any) by which—
the applicable percentage for the fiscal year so specified of the maximum capped allocation due to the State or sub-State jurisdiction for fiscal year 2019 for foster care maintenance, administration, or training costs, under the demonstration project, as specified in section 4.3 of the State waiver terms and conditions document capped allocation payment table in effect on August 31, 2019; or
if the terms and conditions do not specify a maximum amount payable for fiscal year 2019 for the State or sub-State jurisdiction (due to the use of a comparison jurisdiction to ensure cost neutrality), the final cost neutrality limit for the State or sub-State jurisdiction for fiscal year 2018, as most recently reported by the State or sub-State jurisdiction as of September 30, 2019, for foster care maintenance, administration, or training costs under the demonstration project that were included in the waiver; exceeds
the total amount payable to the State or sub-State jurisdiction under part E of title IV of such Act for the fiscal year so specified for foster care expenditures (whether payable under paragraph (1) or (3) of section 474(a) of such Act) that were maintenance, administration, or training costs of the demonstration project taken into account by the Secretary in determining the total amount referred to in clause (i) of this subparagraph.
Applicable percentage defined.— In this subparagraph, the term “applicable percentage” means—
90 percent, in the case of fiscal year 2020; or
75 percent, in the case of fiscal year 2021.
Special rule.— The calculation under subparagraph (A) with respect to a State shall be made without regard to—
any change approved after August 31, 2019, in the capped allocation or the terms and conditions referred to in clause (i) of subparagraph (A) with respect to the State; or
any change made after such date to the financial form submitted by the State that is used in determining the capped allocation.
Distribution of funds.— Each State that receives funds under this paragraph shall distribute the funds to jurisdictions in the State that were operating demonstration projects under section 1130 of the Social Security Act in a manner consistent with each sub-State jurisdiction’s proportionate loss as compared with fiscal year 2019.
Reconciliation process.— Each State seeking a payment under this paragraph shall report expenditures pursuant to part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.) in a manner determined by the Secretary and the Secretary shall account for any revisions to spending for fiscal years 2020 and 2021 after the end of the respective fiscal year that are reported by the State agency administering the State plan approved under such part, and received by the Department of Health and Human Services, within 2 years after the last day of the fiscal quarter in which the expenditure was made.
Availability of funds.— The amounts made available for payments to States under this paragraph for a fiscal year shall remain available through the end of the third succeeding fiscal year.
Use of funds.—
In general.— In addition to the purposes specified in part B of title IV of the Social Security Act (42 U.S.C. 671 et seq.), a State may use funds provided under this subsection for activities previously funded under a demonstration project under section 1130 of such Act (42 U.S.C. 1320a–9) to reduce any adverse fiscal impacts as jurisdictions transition funding sources for the projects, and for activities directly associated with the implementation of title VII of division E of Public Law 115–123 (also known as the Family First Prevention Services Act).
Limitation.— None of the funds provided under this subsection may be used to match Federal funds under any program.
Reporting on Enhanced Funding for Transition Activities.—
In general.— Each State to which funds are paid under subsection (c) of this section shall submit to the Secretary, in a manner specified by the Secretary, a written report on—
how the grant is used to implement each part of title VII of division E of Public Law 115–123 (also known as the Family First Prevention Services Act), with a separate statement with respect to each such part;
all programs, services, and operational costs to which the grant is put;
the characteristics of the families and children served by use of the grant; and
the use by the State of amounts provided for each fiscal year to continue activities previously funded under a waiver provided under section 1130 of the Social Security Act (42 U.S.C. 1320a–9); and
the plan of the State to transition the activities so that needed activities can be provided under the State plan approved under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.); or
if expenditures for the activities would not be eligible for payment under the State plan approved under such part E—
the reason therefor; and
the funding sources the State plans to use to cover the costs of needed activities.
Applicability of other laws.— For purposes of subpart 2 of part B of title IV of the Social Security Act (42 U.S.C. 629 et seq.), each report required by paragraph (1) of this subsection shall be considered to be required by section 432(a)(8) of such Act (42 U.S.C. 629b(a)(8)), and shall contain such additional information as the Secretary may require.
Definition of State.— In this section, the term “State” has the meaning given the term in section 431(a)(4) of the Social Security Act (42 U.S.C. 629a(a)(4)).
Renaming of Title IV–B–2 of the Social Security Act.— The subpart heading for subpart 2 of part B of title IV of the Social Security Act is amended by striking “ Promoting Safe and Stable Families” and inserting “ MaryLee Allen Promoting Safe and Stable Families Program”.
Effective Date.— This section and the amendments made by this section shall take effect as if included in the Bipartisan Budget Act of 2018 on the date of the enactment of such Act.
Technical Correction.— Section 50701 of the Bipartisan Budget Act of 2018 (42 U.S.C. 1305 note; Public Law 115–123) is amended by striking “ Bipartisan Budget Act of 2018” and inserting “ Family First Prevention Services Act”.
SEC. 603. Minimum Age of Sale of Tobacco Products.
In General.— Section 906(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is amended—
in paragraph (3)(A)(ii), by striking “ 18 years” and inserting “ 21 years”; and
by adding at the end the following:
“(5) Minimum age of sale.—It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.”
Regulations.—
In general.— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall publish in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) as appropriate, only to carry out the amendments made by subsection (a), including to update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30. Such final rule shall—
take full effect not later than 90 days after the date on which such final rule is published; and
be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code and all other provisions of law relating to rulemaking procedures.
Other regulations.— Prior to making amendments to part 1140 of title 21, Code of Federal Regulations other than the amendments described in paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, United States Code.
Notification.— Not later than 90 days after the date of enactment of this Act, the Secretary shall provide written notification to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the progress of the Department of Health and Human Services towards promulgating the final rule under subsection (b). If, 180 days after the date of enactment of this Act, such rule has not been promulgated in accordance with subsection (b), the Secretary shall provide a written notification and a justification for the delay in rulemaking to such committees.
Penalties for Violations.—
In general.— Section 103(q)(2) of the Family Smoking Prevention and Tobacco Control Act (Public Law 111–31) is amended—
in subparagraph (A), in the matter preceding clause (i), by inserting “ section 906(d)(5) or of” after “ violations of”; and
in subparagraph (C), by inserting “ section 906(d)(5) or of” after “ a retailer of”.
Repeated violations.— Section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) is amended by inserting “ section 906(d)(5) or of” after “ repeated violations of”.
Misbranded products.— Section 903(a)(7)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387c) is amended by inserting “ section 906(d)(5) or of” after “ violation of”.
SEC. 604. Sale of Tobacco Products to Individuals under the Age of 21.
in the heading—
by striking “ state law regarding”; and
by striking “ 18” and inserting “ 21”;
by striking subsections (a) and (d);
by redesignating subsections (b) and (c) as subsections (a) and (b), respectively;
by amending subsection (a), as so redesignated, to read as follows:
“(a) In General.—A funding agreement for a grant under section 1921 is that the State involved will—
“(1) annually conduct random, unannounced inspections to ensure that retailers do not sell tobacco products to individuals under the age of 21; and
“(2) annually submit to the Secretary a report describing—
“(A) the activities carried out by the State to ensure that retailers do not sell tobacco products to individuals under the age of 21;
“(B) the extent of success the State has achieved in ensuring that retailers do not sell tobacco products to individuals under the age of 21; and
“(C) the strategies to be utilized by the State to ensure that retailers do not sell tobacco products to individuals under the age of 21 during the fiscal year for which the grant is sought.”
in subsection (b), as so redesignated—
by striking paragraphs (1), (2), (3), and (4);
by striking “ Before making” and inserting the following:
“(1) In general.—Before making”
by striking “ for the first applicable fiscal year or any subsequent fiscal year”;
by striking “ subsections (a) and (b)” and inserting “ subsection (a)”;
by striking “ equal to—” and inserting “ up to 10 percent of the amount determined under section 1933 for the State for the applicable fiscal year.”; and
by adding at the end the following:
“(2) Limitation.—
“(A) In general.—A State shall not have funds withheld pursuant to paragraph (1) if such State for which the Secretary has made a determination of noncompliance under such paragraph—
“(i) certifies to the Secretary by May 1 of the fiscal year for which the funds are appropriated, consistent with subparagraph (B), that the State will commit additional State funds, in accordance with paragraph (1), to ensure that retailers do not sell tobacco products to individuals under 21 years of age;
“(ii) agrees to comply with a negotiated agreement for a corrective action plan that is approved by the Secretary and carried out in accordance with guidelines issued by the Secretary; or
“(iii) is a territory that receives less than $1,000,000 for a fiscal year under section 1921.
“(B) Certification.—
“(i) In general.—The amount of funds to be committed by a State pursuant to subparagraph (A)(i) shall be equal to 1 percent of such State’s substance abuse allocation determined under section 1933 for each percentage point by which the State misses the retailer compliance rate goal established by the Secretary.
“(ii) State expenditures.—For a fiscal year in which a State commits funds as described in clause (i), such State shall maintain State expenditures for tobacco prevention programs and for compliance activities at a level that is not less than the level of such expenditures maintained by the State for the preceding fiscal year, plus the additional funds for tobacco compliance activities required under clause (i). The State shall submit a report to the Secretary on all State obligations of funds for such fiscal year and all State expenditures for the preceding fiscal year for tobacco prevention and compliance activities by program activity by July 31 of such fiscal year.
“(iii) Discretion.—The Secretary shall exercise discretion in enforcing the timing of the State obligation of the additional funds required by the certification described in subparagraph (A)(i) as late as July 31 of such fiscal year.
“(C) Failure to certify.—If a State described in subparagraph (A) fails to certify to the Secretary pursuant to subparagraph (A)(i) or enter into, or comply with, a negotiated agreement under subparagraph (A)(ii), the Secretary may take action pursuant to paragraph (1).”
; and
by adding at the end the following:
“(c) Implementation of Reporting Requirements.—
“(1) Transition period.—The Secretary shall—
“(A) not withhold amounts under subsection (b) for the 3-year period immediately following the date of enactment of division N of the Further Consolidated Appropriations Act, 2020; and
“(B) use discretion in exercising its authority under subsection (b) during the 2-year period immediately following the 3-year period described in subparagraph (A), to allow for a transition period for implementation of the reporting requirements under subsection (a)(2).
“(2) Regulations or guidance.—Not later than 180 days after the date of enactment of division N of the Further Consolidated Appropriations Act, 2020, the Secretary shall update regulations under part 96 of title 45, Code of Federal Regulations or guidance on the retailer compliance rate goal under subsection (b), the use of funds provided under section 1921 for purposes of meeting the requirements of this section, and reporting requirements under subsection (a)(2).
“(3) Coordination.—The Secretary shall ensure the Assistant Secretary for Mental Health and Substance Use coordinates, as appropriate, with the Commissioner of Food and Drugs to ensure that the technical assistance provided to States under subsection (e) is consistent with applicable regulations for retailers issued under part 1140 of title 21, Code of Federal Regulations.
“(d) Transitional Grants.—
“(1) In general.—The Secretary shall award grants under this subsection to each State that receives funding under section 1921 to ensure compliance of each such State with this section.
“(2) Use of funds.—A State receiving a grant under this subsection—
“(A) shall use amounts received under such grant for activities to plan for or ensure compliance in the State with subsection (a); and
“(B) in the case of a State for which the Secretary has made a determination under subsection (b) that the State is prepared to meet, or has met, the requirements of subsection (a), may use such funds for tobacco cessation activities, strategies to prevent the use of tobacco products by individuals under the age of 21, or allowable uses under section 1921.
“(3) Supplement not supplant.—Grants under this subsection shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under paragraph (2).
“(4) Authorization of appropriations.—To carry out this subsection, there are authorized to be appropriated $18,580,790 for each of fiscal years 2020 through 2024.
“(5) Sunset.—This subsection shall have no force or effect after September 30, 2024.
“(e) Technical Assistance.—The Secretary shall provide technical assistance to States related to the activities required under this section.”
Report to Congress.— Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the status of implementing the requirements of section 1926 of the Public Health Service Act (42 U.S.C. 300x–26), as amended by subsection (a), and a description of any technical assistance provided under subsection (e) of such section, including the number of meetings requested and held related to technical assistance.
Conforming Amendment.— Section 212 of division D of the Consolidated Appropriations Act, 2010 (Public Law 111–117) is repealed.
SEC. 605. Biological Product Definition.
Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended by striking “ (except any chemically synthesized polypeptide)”.
SEC. 606. Protecting Access to Biological Products.
Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 262(k)(7)) is amended by adding at the end the following:
“(D) Deemed licenses.—
“(i) No additional exclusivity through deeming.—An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).
“(ii) Application of limitations on exclusivity.—Subparagraph (C) shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.
“(iii) Applicability.—The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection (a) pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.”
SEC. 607. Streamlining the Transition of Biological Products.
Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) is amended—
by striking “ An approved application” and inserting the following:
“(A) In general.—An approved application”
; and
by adding at the end the following:
“(B) Treatment of certain applications.—
“(i) In general.—With respect to an application for a biological product submitted under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is filed not later than March 23, 2019, and is not approved as of March 23, 2020, the Secretary shall continue to review such application under such section 505 after March 23, 2020.
“(ii) Effect on listed drugs.—Only for purposes of carrying out clause (i), with respect to any applicable listed drug with respect to such application, the following shall apply:
“(I) Any drug that is a biological product that has been deemed licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) pursuant to subparagraph (A) and that is referenced in an application described in clause (i), shall continue to be identified as a listed drug on the list published pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and the information for such drug on such list shall not be revised after March 20, 2020, until—
“(aa) such drug is removed from such list in accordance with subclause (III) or subparagraph (C) of such section 505(j)(7); or
“(bb) this subparagraph no longer has force or effect.
“(II) Any drug that is a biological product that has been deemed licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) pursuant to subparagraph (A) and that is referenced in an application described in clause (i) shall be subject only to requirements applicable to biological products licensed under such section.
“(III) Upon approval under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act of an application described in clause (i), the Secretary shall remove from the list published pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act any listed drug that is a biological product that has been deemed licensed under section 351 of the Public Health Service Act pursuant to subparagraph (A) and that is referenced in such approved application, unless such listed drug is referenced in one or more additional applications described in clause (i).
“(iii) Deemed licensure.—Upon approval of an application described in clause (i), such approved application shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act.
“(iv) Rule of construction.—
“(I) Application of certain provisions.—
“(aa) Patent certification or statement.—An application described in clause (i) shall contain a patent certification or statement described in, as applicable, section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act or clauses (vii) and (viii) of section 505(j)(2)(A) of such Act and, with respect to any listed drug referenced in such application, comply with related requirements concerning any timely filed patent information listed pursuant to section 505(j)(7) of such Act.
“(bb) Date of approval.—The earliest possible date on which any pending application described in clause (i) may be approved shall be determined based on—
“(AA) the last expiration date of any applicable period of exclusivity that would prevent such approval and that is described in section 505(c)(3)(E), 505(j)(5)(B)(iv), 505(j)(5)(F), 505A, 505E, or 527 of the Federal Food, Drug, and Cosmetic Act; and
“(BB) if the application was submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act and references any listed drug, the last applicable date determined under subparagraph (A), (B), or (C) of section 505(c)(3) of such Act, or, if the application was submitted under section 505(j) of such Act, the last applicable date determined under clause (i), (ii), or (iii) of section 505(j)(5)(B) of such Act.
“(II) Exclusivity.—Nothing in this subparagraph shall be construed to affect section 351(k)(7)(D) of the Public Health Service Act.
“(v) Listing.—The Secretary may continue to review an application after March 23, 2020, pursuant to clause (i), and continue to identify any applicable listed drug pursuant to clause (ii) on the list published pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, even if such review or listing may reveal the existence of such application and the identity of any listed drug for which the investigations described in section 505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act are relied upon by the applicant for approval of the pending application. Nothing in this subparagraph shall be construed as authorizing the Secretary to disclose any other information that is a trade secret or confidential information described in section 552(b)(4) of title 5, United States Code.
“(vi) Sunset.—Beginning on October 1, 2022, this subparagraph shall have no force or effect and any applications described in clause (i) that have not been approved shall be deemed withdrawn.”
SEC. 608. Reenrollment of Certain Individuals in Qualified Health Plans in Certain Exchanges.
Section 1311(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)) is amended by adding the end the following new paragraph:
“(7) Reenrollment of certain individuals in qualified health plans in certain exchanges.—
“(A) In general.—In the case of an Exchange that the Secretary operates pursuant to section 1321(c)(1), the Secretary shall establish a process under which an individual described in subparagraph (B) is reenrolled for plan year 2021 in a qualified health plan offered through such Exchange. Such qualified health plan under which such individual is so reenrolled shall be—
“(i) if available for plan year 2021, the qualified health plan under which such individual is enrolled during the annual open enrollment period for such plan year; and
“(ii) if such qualified health plan is not available for plan year 2021, a qualified health plan offered through such Exchange determined appropriate by the Secretary.
“(B) Individual described.—An individual described in this subsection is an individual who, with respect to plan year 2020—
“(i) resides in a State with an Exchange described in subparagraph (A);
“(ii) is enrolled in a qualified health plan during such plan year and does not enroll in a qualified health plan for plan year 2021 during the annual open enrollment period for such plan year 2021; and
“(iii) does not elect to disenroll under a qualified health plan for plan year 2021 during such annual open enrollment period.”
SEC. 609. Protection of Silver Loading Practice.
With respect to plan year 2021, the Secretary of Health and Human Services may not take any action to prohibit or otherwise restrict the practice commonly known as “silver loading” (as described in the rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020” published on April 25, 2019 (84 Fed. Reg. 17533)).
SEC. 610. Actions for Delays of Generic Drugs and Biosimilar Biological Products.
Definitions.— In this section—
the term “commercially reasonable, market-based terms” means—
a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B));
a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and
no additional conditions are imposed on the sale of the covered product;
the term “covered product”—
means—
any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262);
any combination of a drug or biological product described in clause (i); or
when reasonably necessary to support approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or section 351 of the Public Health Service Act (42 U.S.C. 262), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and
does not include any drug or biological product that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e), unless—
the drug or biological product has been on the drug shortage list in effect under such section 506E continuously for more than 6 months; or
the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.
the term “device” has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);
the term “eligible product developer” means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k));
the term “license holder” means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) for a covered product;
the term “REMS” means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1);
the term “REMS with ETASU” means a REMS that contains elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f));
the term “Secretary” means the Secretary of Health and Human Services;
the term “single, shared system of elements to assure safe use” means a single, shared system of elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)); and
the term “sufficient quantities” means an amount of a covered product that the eligible product developer determines allows it to—
conduct testing to support an application under—
subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or
section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); and
fulfill any regulatory requirements relating to approval of such an application.
Civil Action for Failure To Provide Sufficient Quantities of a Covered Product.—
In general.— An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.
Elements.—
In general.— To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—
that—
the covered product is not subject to a REMS with ETASU; or
if the covered product is subject to a REMS with ETASU—
the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and
the eligible product developer has provided a copy of the covered product authorization to the license holder;
that, as of the date on which the civil action is filed, the eligible product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;
that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder, and such request—
was sent to a named corporate officer of the license holder;
was made by certified or registered mail with return receipt requested;
specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual; and
specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product; and
that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—
for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and
for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—
the date on which the license holder received the request for the covered product; or
the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).
Authorization for covered product subject to a rems with etasu.—
Request.— An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU.
Authorization.— Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—
development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or
development and testing that involves human clinical trials, if the eligible product developer has—
submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or
otherwise satisfied the Secretary that such protections will be provided; and
met any other requirements the Secretary may establish.
Notice.— A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product.
Affirmative defense.— In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—
that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—
neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and
neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;
that—
the license holder sells the covered product through agents, distributors, or wholesalers;
the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and
the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or
that the license holder made an offer to the individual specified pursuant to paragraph (2)(A)(iii)(III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—
for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or
for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.
Remedies.—
In general.— If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—
order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;
award to the eligible product developer reasonable attorney’s fees and costs of the civil action; and
award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—
that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or
that the license holder failed to comply with an order issued under clause (i).
Maximum monetary amount.— A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—
beginning on—
for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or
for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—
the date on which the license holder received the request; or
the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and
ending on the date on which the eligible product developer received sufficient quantities of the covered product.
Avoidance of delay.— The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.
Limitation of Liability.— A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.
No Violation of REMS.— Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) is amended by adding at the end the following new subsection:
“(l) Provision of Samples Not a Violation of Strategy.—The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 610(a) of division N of the Further Consolidated Appropriations Act, 2020) shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug.”
Rule of Construction.—
Definition.— In this subsection, the term “antitrust laws”—
has the meaning given the term in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12); and
includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent that such section applies to unfair methods of competition.
Antitrust laws.— Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.
REMS Approval Process for Subsequent Filers.— Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), as amended by subsection (d), is further amended—
in subsection (g)(4)(B)—
in clause (i) by striking “ or” after the semicolon;
in clause (ii) by striking the period at the end and inserting “ ; or”; and
by adding at the end the following:
“(iii) accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug.”
in subsection (i)(1), by striking subparagraph (C) and inserting the following:
“(C)
(i) Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) may use—
“(I) a single, shared system with the listed drug under subsection (f); or
“(II) a different, comparable aspect of the elements to assure safe use under subsection (f).
“(ii) The Secretary may require a drug that is the subject of an application under section 505(j) and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).”
in subsection (i), by adding at the end the following:
“(3) Shared rems.—If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 505(j), the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 505(j) or 505(b) that references the same listed drug.”
; and
by adding at the end the following:
“(m) Separate REMS.—When used in this section, the term ‘different, comparable aspect of the elements to assure safe use’ means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy.”
Rule of Construction.— Nothing in this section, the amendments made by this section, or in section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), shall be construed as—
prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this section; or
in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 505–1, with respect to such covered product.