Ensuring patient affordability of drugs purchased under section 340B

(a) In general Section 340B(a)(5) of the Public Health Service Act (42 U.S.C. 256b(a)(5)) is further amended by adding at the end the following: (G) Patient affordability requirements for hospital covered entities (i) In general Notwithstanding any other provision of law, a covered entity described in one of subparagraphs (L) through (O) of paragraph (4) shall establish a sliding fee scale that results in the covered entity providing, on behalf of an eligible patient (as defined in clause (iv)), a discount that results in such patient paying no more than the maximum out-of-pocket obligation (as defined in clause (ii)), with respect to each covered outpatient drug subject to an agreement under this section dispensed, furnished, or administered to such patient at such covered entity, any child site, or any entity pharmacy. The sliding fee scale and related policies shall be written and posted prominently at each such covered entity location, including any child site and entity pharmacy, and shall be included in any billing-related communications sent by such covered entity to any patient dispensed, furnished, or administered a covered outpatient drug at such covered entity location, including any child site or entity pharmacy. Eligibility for a reduced out-of-pocket obligation pursuant to this clause shall be based on insurance and income information provided by the eligible patient. With respect to covered outpatient drugs that are self-administered by an eligible patient, the out-of-pocket reductions described in this clause shall apply at the point of sale. (ii) Maximum out-of-pocket obligation For each dispense or administration of a covered outpatient drug, the maximum out-of-pocket obligation for an eligible patient with family income— (I) below the Federal poverty guidelines is $0; (II) at or above the Federal poverty guidelines but below 200 percent of the Federal poverty guidelines is the lesser of 20 percent of the otherwise applicable out-of-pocket obligation or $35, which shall be adjusted for inflation annually to reflect rate of the change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; and (III) at or above 200 percent of the Federal poverty guidelines is the lesser of 30 percent of the otherwise applicable out-of-pocket obligation or $50, which shall be adjusted for inflation annually to reflect rate of the change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics. (iii) Applicability to contract pharmacies With respect to an eligible patient of a covered entity described in clause (i) dispensed a covered outpatient drug subject to an agreement under this section on behalf of such covered entity at a contract pharmacy pursuant to subparagraph (F), such covered entity shall require such contract pharmacy to provide discounts to eligible patients on behalf of such covered entity and comply with all other requirements described in clauses (i) and (ii) as if such contract pharmacy were a covered entity described in clause (i). (iv) Definitions In this subparagraph: (I) Child site The term child site shall have the meaning given such term in subparagraph (E). (II) Contract pharmacy The term contract pharmacy shall have the meaning given such term in subparagraph (F). (III) Eligible patient The term eligible patient means a patient, as defined in subsection (b)(3), who is not covered under minimum essential coverage as defined under section 5000A(f) of the Internal Revenue Code of 1986 or has family income below 200 percent of the Federal poverty guidelines and is covered under a group health plan, health insurance coverage in the individual market or group market (as such terms are defined in section 2791 of the Public Health Service Act) or coverage described in section 156.602(a), title 45, Code of Federal Regulations or successor regulation. (IV) Entity pharmacy The term entity pharmacy shall have the meaning given such term in subparagraph (F). (V) Federal poverty guidelines The term Federal poverty guidelines means the poverty guidelines updated periodically in the Federal Register by the Department of Health and Human Services pursuant to section 9902(2) of title 42, United States Code. (VI) Out-of-pocket obligation The term out-of-pocket obligation means any copayment, coinsurance, deductible, or other cost sharing amount or payment required from an eligible patient in connection with such patient’s receipt of a specific health care item or service, including a covered outpatient drug. (v) Civil monetary penalty A covered entity or contract pharmacy that violates a requirement of this subparagraph shall be subject to a civil monetary penalty of $2,500 for each such violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics. The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). The Office of Inspector General of the Department of Health and Human Services shall carry out the provisions of this clause. (vi) Regulations The Secretary shall promulgate regulations through notice and comment rulemaking to implement the requirements described in this subparagraph and shall issue final regulations not later than 90 days after the date of enactment of this subparagraph. The authority to promulgate regulations under this clause is limited to specifying the obligations of covered entities and contract pharmacies under this subparagraph and other details necessary to carry out the requirements of this subparagraph efficiently, effectively, and in conformity with this subparagraph. (vii) OIG studies The Office of Inspector General of the Department of Health and Human Services shall conduct and publish annual studies of covered entity (including child site and entity pharmacy) and contract pharmacy practices with respect to the requirements under this subparagraph and evaluate whether eligible patients are receiving assistance to reduce their out-of-pocket obligations in accordance with this subparagraph. (H) Patient affordability requirements for certain nonhospital covered entities (i) In general Notwithstanding any other provision of law, a covered entity described in one of subparagraphs (A) through (K) of paragraph (4) that is required by the Federal statute authorizing the grant, project, or contract that is the basis for such entity’s participation in the program under this section to provide affordability assistance to eligible individuals receiving health care items or services from such entity shall, with respect to an eligible patient (as defined in clause (iii)) dispensed or administered a covered outpatient drug subject to an agreement under this section at a covered entity site, including an entity pharmacy, establish a policy that provides a discount to reduce the out-of-pocket obligation of an eligible patient with respect to such drug to an amount sufficient to ensure such patient is not denied access to such drug based on such patient’s ability to pay for such drug. (ii) Applicability to contract pharmacies With respect to an eligible patient of a covered entity described in clause (i) dispensed a covered outpatient drug subject to an agreement under this section on behalf of such covered entity at a contract pharmacy pursuant to subparagraph (F), such covered entity shall require such contract pharmacy to provide discounts to eligible patients on behalf of such covered entity in accordance with the covered entity’s policy described in clause (i). (iii) Definitions In this subparagraph: (I) Contract pharmacy The term contract pharmacy shall have the meaning given such term in subparagraph (F). (II) Eligible patient The term eligible patient means a patient, as defined in subsection (b)(3), who is not covered under minimum essential coverage as defined under section 5000A(f) of the Internal Revenue Code of 1986 or has family income below 200 percent of the Federal poverty guidelines and is covered under a group health plan, health insurance coverage in the individual market or group market (as such terms are defined in section 2791 of the Public Health Service Act) or coverage described in section 156.602(a), title 45, Code of Federal Regulations or successor regulation. (III) Entity pharmacy The term entity pharmacy shall have the meaning given such term in subparagraph (F). (IV) Federal poverty guidelines The term Federal poverty guidelines means the poverty guidelines updated periodically in the Federal Register by the Department of Health and Human Services pursuant to section 9902(2) of title 42, United States Code. (V) Out-of-pocket obligation The term out-of-pocket obligation means any copayment, coinsurance, deductible, or other cost sharing amount or payment required from an eligible patient in connection with such patient’s receipt of a specific health care item or service, including a covered outpatient drug..