Improving patient affordability and protections

Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is further amended by adding at the end the following: (15) Patient assistance programs (A) In general Covered entities shall maintain and extend their patient financial assistance policy to patients served by their child sites and contract pharmacies. The covered entity shall ensure that its financial assistance policy is transparent to patients at point of care, satisfies the notice requirements in paragraph (C), and publicly reported. The Secretary shall establish a process, through notice and comment rulemaking, to require covered entities to maintain auditable records related to the implementation and enforcement of this paragraph. Nothing in this section shall be construed to require a covered entity to waive or eliminate all patient cost-sharing or other out-of-pocket obligations, or to provide covered outpatient drugs or related services at no cost, except to the extent required under the covered entity’s generally applicable financial assistance policy. (B) Financial assistance policy defined In this paragraph, a financial assistance policy means a written financial assistance policy described in section 501(r)(4)(A) of the Internal Revenue Code of 1986, provided to patients— (i) up to at least 400 percent of the Federal poverty level, for covered entities described under subparagraph (L), (M), (N), and (O) of subsection (a)(4); (ii) up to at least 200 percent of the Federal poverty level, for all covered entities not described in paragraph 14(b)(i) that are not otherwise subject to sliding fee schedule or grant requirements by law; and (iii) a sliding fee scale for covered outpatient drugs dispensed to patients under the drug discount program under this section, as applicable, provided that— (I) for covered entities described under subparagraph (L), (M), (N), and (O) of subsection (a)(4)— (aa) such sliding fee schedule must be made available for all patients up to at least 400 percent of the Federal poverty level; and (bb) copayment requirements under such sliding fee schedule must be nominal in amount; or (II) such other alternative policy as the Secretary may determine through notice and comment rulemaking with respect to a specific covered entity. (C) Notice (i) Covered entities shall provide adequate notice and application of any financial assistance policy described in subparagraph (A). (ii) In order to ensure meaningful understanding of eligibility of a patient for a financial assistance policy, any notice described in clause (i) must be made available to patients of the covered entity— (I) in a plain-language summary (as defined in 42 U.S. Code 18031(e)(3)(B)) in English; and (II) if English is not the primary language in the community served by the covered entity, in the primary language served by such community. (D) Implementation for contract pharmacies The financial assistance policies under this section shall apply to contract pharmacies by the following timeline: (i) prospectively to all newly registered contract pharmacy locations after the enactment of this clause; or (ii) not later than 3 years after the date of enactment of this clause for all other contract pharmacy locations. (E) Oversight The Comptroller General of the United States shall conduct a study and report to Congress on the impact of requirements of this paragraph on patient access to covered outpatient drugs purchased under this section. (F) Rule of construction Compliance with this paragraph shall not be considered a prohibited act under section 1128A, 1128B(b), or 1877 of the Social Security Act. (16) Medical debt (A) Prohibitions (i) In general Covered entities described under subparagraph (L), (M), (N), and (O) of subsection (a)(4) shall not— (I) sell a patient’s debt to another party; (II) report adverse information about an individual to consumer credit reporting agencies or credit bureaus; and (III) defer or deny, or require a payment before providing, medically necessary care, because of an individual’s non-payment of one or more bills. (ii) Exception A covered entity described under subparagraph (L), (M), (N), and (O) of subsection (a)(4) may sell an individual’s debt to another party if the party’s sole purpose is to pay for the individual’s debt in full. (B) Debt collection (i) In general Except as provided in clause (ii), covered entities described under subparagraph (L), (M), (N), and (O) of subsection (a)(4) shall not take any legal action to collect debt from a patient at such covered entity. (ii) Exception A covered entity described under subparagraph (L), (M), (N), and (O) of subsection (a)(4) may collect debt only from patients with a clear ability to pay, as demonstrated by the greater of— (I) income at or above 600 percent of the Federal poverty level; or (II) assets valued at more than 400 percent of the patient’s outstanding balance of debt owed to the covered entity. (iii) Interest A covered entity described under subparagraph (L), (M), (N), and (O) of subsection (a)(4) shall be prohibited from charging interest on any outstanding balance of debt owed by a patient to such covered entity that is more than the allowable percentage specified in the applicable usury laws or regulations of the State in which the covered entity is located. (C) Monitoring compliance (i) In general The Secretary shall conduct an annual review, in a form and manner established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment of this subparagraph, to monitor covered entity compliance with the requirements of this paragraph. (ii) Enforcement If the Secretary finds that, as a result of a review described in clause (i), a covered entity is not in compliance with the requirements of this paragraph, the Secretary shall— (I) impose civil monetary penalties, which— (aa) shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment of this subclause; and (bb) shall not exceed $5,000 for each instance of noncompliance that may have occurred; (II) where the Secretary determines that a violation of this paragraph was systematic and egregious as well as knowing and intentional, refer matters to appropriate authorities within the Office of Inspector General of the Department of Health and Human Services; and (III) where the Secretary determines that a covered entity may not be in compliance with the requirements of section 501(r) of the Internal Revenue Code of 1986, refer matters to appropriate authorities within the Internal Revenue Service. (D) GAO report Not later than 2 years after the enactment of this subparagraph, and every 2 years thereafter, the Comptroller General of the United States shall submit to the Secretary and to the appropriate committees of Congress a report that— (i) analyzes covered entity compliance with the requirements described in this paragraph; and (ii) makes recommendations with respect to policies intended to improve compliance with the requirements described in this paragraph. (E) Inspector general report The Inspector General of the Department of Health and Human Services shall conduct an annual risk-based assessment of covered entity compliance with the requirements of this paragraph..