Patient financial assistance

Section 340B(a)(5) of the Public Health Service Act (42 U.S.C. 256b(a)(5)), as amended by section 8(b), is further amended by adding at the end the following: (H) Patient financial assistance (i) In general Each covered entity shall— (I) ensure that its financial assistance policy is transparent to patients at point of care and publicly reported; (II) apply such financial assistance policy to patients served by child sites and contract pharmacies; and (III) upon request of the Secretary, submit its financial assistance policy to the Secretary. (ii) Records The Secretary shall require covered entities to maintain, for a period of at least 3 years, auditable records related to the implementation and enforcement of this subparagraph. (iii) Financial assistance policy defined In this subparagraph, a financial assistance policy means— (I) (aa) a written financial assistance policy described in section 501(r)(4)(A) of the Internal Revenue Code of 1986, provided, at least, to patients at 200 percent of the Federal poverty level or less; and (bb) a sliding fee scale for covered outpatient drugs dispensed to patients under the drug discount program under this section, as applicable; or (II) such other alternative policy as the Secretary may determine with respect to a specific covered entity. (iv) Oversight The Comptroller General of the United States shall conduct a study and report to Congress on the impact of requirements of this subparagraph on patient access to covered outpatient drugs purchased under this section. (v) Language requirements A covered entity shall make the financial assistance policy described in clause (i) available to patients, including patients served by child sites and contract pharmacies in plain language (as defined in section 1311(e)(3)(B)of the Patient Protection and Affordable Care Act). (vi) Rule of construction Compliance with this subparagraph shall not be considered a prohibited act under section 1128A, 1128B(b), or 1877 of the Social Security Act. (vii) Delayed effective date for certain entities With respect to a child site or contract pharmacy, the requirements of this subparagraph shall apply beginning on the date that is 3 years after the date of enactment of the SUSTAIN 340B Act..