Sec. 4. Provision of Hepatitis C treatments to certain populations
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/bill/119/s/1941/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
In this section: The term covered population means the population of individuals determined under subsection (b)(2). The term minimum essential coverage means health insurance coverage under a public or private plan that constitutes minimum essential coverage under section 5000A(f)(1) of the Internal Revenue Code of 1986. The term participating State or local correctional system means a State or local correctional system that opts to participate in the program under subsection (b)(3)(A).
The term program means the subscription program for hepatitis C treatments established under subsection (b)(1). The terms registered pharmacy and registered site of dispensing mean a pharmacy or site of dispensing, respectively, that enters into an agreement with the Secretary under subsection (b)(5)(B). The Secretary shall establish a subscription program for hepatitis C treatments under which— the Secretary— shall enter into agreements with 1 or more drug manufacturers for the purchase of hepatitis C treatments under a subscription model described in paragraph (4); and shall provide for the distribution of hepatitis C treatments purchased under such agreements among registered pharmacies and registered sites of dispensing, participating State and local correctional systems, the Bureau of Prisons, and facilities of the Indian Health Service, in accordance with paragraph (5); and each individual within the covered population, in receiving hepatitis C treatments that were purchased under such an agreement, is entitled to receive the treatments without cost-sharing.
Health care providers, pharmacies, and sites of dispensing shall not utilize any other Federal drug discount program, including the drug discount program under section 340B of the Public Health Service Act ( 42 U.S.C. 256b ), with respect to hepatitis C treatments obtained through the program. To ensure compliance with clause (i), the Secretary shall— ensure that relevant data, including data on health care providers, pharmacies, manufacturers, and sites of dispensing participating in the program, is available for administration of the drug discount program under such section 340B; provide necessary resources, from the amounts made available to the Secretary under this section, to carry out program audit, oversight, and administrative activities; supplement existing audit guidance issued pursuant to section 340B(a)(5)(C) of the Public Health Service Act ( 42 U.S.C. 256b(a)(5)(C) ) to give notice to relevant health care providers, pharmacies, and sites of dispensing related to the prohibition and its enforcement; and audit, at the Secretary’s expense, the records of any participating health care provider or registered pharmacy or registered site of dispensing to ensure compliance with the requirements under this subsection.
Nothing in this paragraph shall prohibit a covered entity (as defined in section 340B(a)(4) of the Public Health Service Act ( 42 U.S.C. 256b(a)(4) )) that receives hepatitis C treatments under the program from purchasing hepatitis C treatments pursuant to an agreement under section 340B(a)(1) of such Act ( 42 U.S.C. 256b(a)(1) ), provided that such covered entity complies with section (B)(i). Subject to subparagraph (B), the covered population of individuals entitled to receive hepatitis C treatment under the program in accordance with paragraph (1)(A)(ii) is composed of individuals who have been diagnosed with hepatitis C infection and who— subject to paragraph (3)(A)— are enrolled in medical assistance under a State Medicaid program that is participating in the program; are enrolled in child health assistance or pregnancy-related assistance under a State CHIP program that is participating in the program; or are confined in a correctional facility operated by or on behalf of a participating State or local correctional system; or were confined in a correctional facility operated by or on behalf of a participating State or local correctional system, and who, at the time of release from confinement, had started but not completed a course of hepatitis C treatment; are confined in a facility operated by or on behalf of the Bureau of Prisons; or were confined in a facility operated by or on behalf of the Bureau of Prisons, and who, at the time of release from confinement, had started but not completed a course of hepatitis C treatment; are without minimum essential coverage; or receive health care services through an Indian health program.
In the case of an individual described in subclause
(I)or
(II)of subparagraph (A)(i), the State Medicaid or CHIP program, as applicable, shall coordinate with registered pharmacies and registered sites of dispensing to verify such individual’s enrollment in the State Medicaid program or State CHIP program, as applicable, before the dispensing of a hepatitis C treatment to the individual in accordance with paragraph (1)(A)(ii). The Director of the Bureau of Prisons shall issue a policy regarding determining which individuals in the custody of the Bureau of Prisons are eligible to receive hepatitis C treatment in accordance with paragraph (1)(A)(ii). In the case of an individual described in subparagraph (A)(iii), a health care provider designated under subclause
(II)shall— assess whether such individual qualifies as an individual without minimum essential coverage; and if such individual qualifies as an individual without minimum essential coverage, authorize such individual to receive hepatitis C treatment in accordance with paragraph (1)(A)(ii). The Secretary, in consultation with State public health departments, shall designate health care providers for purposes of subclause (I). For purposes of verifying whether an individual is authorized under subclause (I)(bb), the Secretary shall maintain, and make available to registered pharmacies and registered sites of dispensing that are dispensing hepatitis C treatment under the program, a list of health care providers designated under subclause (II). The Secretary shall issue guidance for health care providers designated under subclause
(II)to make determinations under subclause (I)(aa) based on relevant best practices from the program under title XXVI of the Public Health Service Act ( 42 U.S.C. 300ff–11 et seq. ; commonly referred to as the Ryan White HIV/AIDS Program ) and the program under section 1928 of the Social Security Act ( 42 U.S.C. 1396s ; commonly referred to as the Vaccines for Children program ). The Director of the Indian Health Service shall issue a policy regarding determining which individuals described in subparagraph (A)(iv) are eligible to receive hepatitis C treatment in accordance with paragraph (1)(A)(ii). Each State Medicaid or CHIP agency or State or local correctional system that seeks to participate in the program shall— for the applicable covered population described in subclauses
(I)through
(III)of paragraph (2)(A)(i), opt into the program by notifying the Secretary by the end of such reasonable period as the Secretary may establish; submit to the Secretary a letter of intent for participation for the 5-year term of the agreement entered into under paragraph (4); agree to not impose prior authorization requirements for screening and treatment for hepatitis C virus with respect to hepatitis C treatments obtained pursuant to the program; in the case of a State or local correctional system, agree to provide to individuals described in paragraph (2)(A)(i)(III), upon release from confinement— the remainder of the course of hepatitis C treatment; and a referral to ongoing care; and agree to such other conditions relating to participation in the program as the Secretary may establish. The Bureau of Prisons and the Indian Health Service shall participate in the program. A State or local correctional system that seeks to participate in the program shall agree to provide hepatitis C treatment to an individual in the covered population who is or was confined in a correctional facility operated by or on behalf of the State or local correctional system. The Secretary shall enter into an agreement with 1 or more drug manufacturers for the purchase of hepatitis C treatments under a subscription model described in subparagraph (B). Under a subscription model described in this subparagraph, the Secretary shall enter into an agreement under which 1 or more drug manufacturers agree to provide as many units of hepatitis C treatment as the Secretary requires for the term of the agreement for an amount specified in the agreement, to be paid annually for the term of the agreement. The term of an agreement under subparagraph
(A)shall be 5 years. Subject to clause (ii), in seeking to enter into an agreement under subparagraph (A), the Secretary shall— use competitive procedures to solicit bids from drug manufacturers to provide 100 percent of the hepatitis C treatments for the covered population, as specified by the Secretary under clause (iii); and select 1 or more drug manufacturers whose bid or bids represent the best value to the Federal Government, as determined by the Secretary. In selecting drug manufacturers with which to enter into an agreement under clause (i), the Secretary may enter into an agreement with— a single drug manufacturer to provide 100 percent of the hepatitis C treatments for the covered population, for the total amount specified in the bid submitted by the drug manufacturer; or the drug manufacturer with the best bid, as determined by the Secretary, to provide 70 percent of the hepatitis C treatments for the covered population, for an amount that is 70 percent of the total amount specified in the bid submitted by the drug manufacturer; and the drug manufacturer with the second-best bid, as determined by the Secretary, to provide 30 percent of the hepatitis C treatments for the covered population, for an amount that is 30 percent of the total amount specified in the bid submitted by the drug manufacturer described in item (aa). Prior to beginning the contracting process under this paragraph, and in any case not later than 180 days after the date of enactment of this Act, the Secretary shall specify the covered population, and a reasonable estimate of the size of that population, to support the development of bids by interested drug manufacturers under this subparagraph. In providing for distribution of hepatitis C treatments procured pursuant to 1 or more agreements under paragraph (4), the Secretary may— provide in such an agreement that the drug manufacturer shall— distribute, or provide for the distribution of, such hepatitis C treatments to registered pharmacies and registered sites of dispensing, State and local correctional systems, the Indian Health Service, and the Bureau of Prisons; provide data about distribution in the form and manner prescribed by the Secretary; and meet such other conditions relating to such distribution as are prescribed by the Secretary; or enter into a separate agreement for the distribution of such hepatitis C treatments to registered pharmacies and registered sites of dispensing, State and local correctional systems, the Indian Health Service, and the Bureau of Prisons. A retail pharmacy or site of dispensing that seeks to receive hepatitis C treatments under subparagraph
(A)shall become a registered pharmacy or registered site of dispensing by entering into an agreement with the Secretary under which such retail pharmacy or site of dispensing shall agree— to dispense hepatitis C treatments to individuals described in clauses (i)(I), (i)(II), and
(iii)of paragraph (2)(A); and to such conditions as the Secretary may establish for the program. In providing for the distribution of hepatitis C treatments under an agreement entered into under paragraph (4), the Secretary shall provide for the provision of advance stock of such hepatitis C treatments to registered pharmacies, registered sites of dispensing, participating State and local correctional systems, facilities of the Bureau of Prisons, and facilities of the Indian Health Service with high volumes of patients in need of hepatitis C treatments, as determined by the Secretary. The Secretary shall pay, based on customary and usual fees for the region, reasonable dispensing fees to registered pharmacies that dispense hepatitis C treatments to individuals within the covered population. Registered sites of dispensing, participating State and local correctional systems, facilities of the Bureau of Prisons, and facilities of the Indian Health Service shall use unexpired, on-hand inventory of previously purchased hepatitis C treatments, if any, before dispensing hepatitis C treatments received under subparagraph
(A)to individuals within the covered population. Section 1927 of the Social Security Act ( 42 U.S.C. 1396r–8 ) is amended— in subsection (c)(1)(C)(i)— in subclause (V), by striking ; and and inserting a semicolon; in subclause (VI), by striking the period at the end and inserting ; and ; and by adding at the end the following new subclause: any prices charged under the subscription program for hepatitis C treatments established under section 4(b) of the Cure Hepatitis C Act of 2025 . ; and in subsection (k)(1)(B)(i)— in subclause (IV), by inserting a semicolon at the end; in subclause (VII), by striking ; and and inserting a semicolon; in subclause (VIII), by striking the period at the end and inserting ; and ; and by adding at the end the following new subclause: any prices charged under the subscription program for hepatitis C treatments established under section 4(b) of the Cure Hepatitis C Act of 2025 . . To carry out this section, there is authorized to be appropriated, and there is appropriated, to the Secretary, out of any amounts in the Treasury not otherwise appropriated, $5,500,000,000 for fiscal year 2025, to remain available through fiscal year 2031.
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- 42 USC 300ff–11
- 42 USC 1396r–8
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Sec. 4
Provision of Hepatitis C treatments to certain populations
Cite42 USC 300ff–11
Cite42 USC 1396r–8
Cites 4Cited by 0 across 0 sources