340B claims data clearinghouse

(a) 340B claims data clearinghouse Section 340B(d)(2) of the Public Health Service Act (42 U.S.C. 256b(d)(2)) is amended by adding at the end the following: (C) 340B claims data clearinghouse (i) In general The improvements described in subparagraph (A) shall include the establishment of a claims data clearinghouse described in this subparagraph. Not later than one year after the date of enactment of this subparagraph, the Secretary shall enter into a contract with a third-party entity that meets the criteria specified in clause (ii) (such entity is hereinafter referred to as the clearinghouse) for purposes of— (I) identifying claims for covered outpatient drugs purchased under the program under this section for which reimbursement was made under a State plan (or waiver of such plan) and ensuring such claims are or were not included in any State rebate request under section 1927 of the Social Security Act in violation of sections 1903(m)(2)(A)(xiii) or 1927(j)(1) of such Act or section 340B(a)(5)(A) of this Act; (II) identifying claims for covered outpatient drugs purchased under the program under this section that are selected drugs (as defined in section 1192(c) of the Social Security Act) and ensuring that, for each such claim, the nonduplication requirements of section 1193(d) of such Act have been met; (III) identifying claims for covered outpatient drugs purchased under the program under this section that are either Part B rebatable drugs or Part D rebatable drugs and providing all relevant information regarding such claims to the Secretary to ensure that claims that are subject to a discount under the program under this section are excluded from inflation rebate calculations pursuant to section 1847A(i)(3)(B)(ii)(I) of the Social Security Act (with respect to Part B rebatable drugs) and section 1860D–14B(b)(1)(B) of such Act (with respect to Part D rebatable drugs); (IV) identifying duplicate claims for a rebate or discount submitted by two or more covered entities (or an entity or entities acting on their behalf) with respect to the same unit of a covered outpatient drug purchased under the program under this section and implementing a process to ensure a manufacturer of such a drug does not pay more than one rebate or discount under this section with respect to such unit; and (V) providing to manufacturers of covered outpatient drugs, in a form and manner specified by the Secretary in consultation with manufacturers, access to the data described in subsection (a)(5)(J) with respect to each dispense or administration of a manufacturer’s covered outpatient drugs for which a covered entity receives a discount under this section. (ii) Criteria for clearinghouse The criteria described in this clause include the following: (I) The clearinghouse shall not be owned by, overseen by, or affiliated with a covered entity described in subsection (a)(4) and shall not currently be a party to a contractual arrangement with the Health Resources and Services Administration. (II) The clearinghouse shall have demonstrated experience adjudicating claims for health care items and services in real time for self- and provider-administered drugs and working with protected health information and confidential pricing information. (III) The clearinghouse shall agree to confidentiality obligations that prohibit the clearinghouse from using information it receives under this subparagraph for any purpose other than a purpose set forth in this subparagraph, or disclosing such information to any individual or entity other than the Secretary, provided the Secretary shall not use such information for purposes of making reimbursement or coverage determinations, or a manufacturer in accordance with this subparagraph (and only with respect to such manufacturer’s covered outpatient drugs). (IV) The clearinghouse shall maintain the security of the data reported pursuant to this subsection (a)(5)(J) in a manner consistent with the HIPAA Security Standards set forth in sections 164.304–164.312 and 164.316 of title 45, Code of Federal Regulations (or any successor regulations), as if the clearinghouse were subject to those standards as a HIPAA covered entity. (iii) Duties of clearinghouse The clearinghouse shall— (I) review claims level data for covered outpatient drugs described in subsection (a)(5)(J) submitted by covered entities in accordance with such subsection; (II) review claims level data, including rebate file data, submitted to the clearinghouse by State agencies and Medicaid managed care organizations for covered outpatient drugs subject to an agreement under this section dispensed or administered to individuals enrolled under a State plan (or a waiver of such plan) and claims level data submitted by Medicare Administrative Contractors, Medicare Advantage organizations (including Medicare Advantage Organizations offering an MA–PD plan), and PDP sponsors for covered outpatient drugs subject to an agreement under this section dispensed or administered to individuals enrolled under Part B, Part C, or Part D of title XVIII of the Social Security Act; (III) within 5 days of identification, provide written notice of a duplicate discount or rebate to the State agency, the Secretary, the covered entity, and the affected drug manufacturer itemizing any violation described in clause (i)(I); (IV) within 5 days of identification, provide written notice to the Secretary, the covered entity (or entities, as applicable), and the affected drug manufacturer itemizing any violation described in subclauses (II) or (IV) of clause (i); (V) have access to the internet website described in paragraph (1)(B)(iii) containing applicable ceiling prices for covered outpatient drugs for purposes of identifying violations described in clause (i)(II); (VI) subject to clauses (i)(V) and (ii)(III), make the data described in subclauses (I) and (II) available to the manufacturer in electronic format not later than 10 days after such data is provided to the clearinghouse; (VII) upon request by the Centers for Medicare & Medicaid Services, make the data described in subclauses (I) and (II) available for purposes of excluding 340B purchased units of Part B rebatable drugs or Part D rebatable drugs from Part B or Part D inflation rebates pursuant to section 1847A(i)(3)(B)(ii)(I) or section 1860D–14B(b)(1)(B) of the Social Security Act; and (VIII) identify claims for covered outpatient drugs subject to an agreement under this section that are submitted by pharmacies removed from the 340B program pursuant to subsection (a)(5)(F)(ix)(III) and notify the Secretary of the submission of any such claims by any such pharmacies. (iv) Resolution of violations (I) Medicaid duplicate discounts The Secretary, in consultation with the State, as appropriate, shall take prompt action to fairly and adequately resolve violations described in clause (i)(I) reported by the clearinghouse in accordance with clause (iii)(III). (II) Nonduplication with maximum fair price The Secretary shall take prompt action to fairly and adequately resolve violations described in clause (i)(II) reported by the clearinghouse in accordance with clause (iii)(IV). (III) Duplicate covered entity discounts The Secretary shall develop and implement a process to resolve duplicate claims for a rebate or discount under this section described in clause (i)(IV) such that the manufacturer pays only one rebate or discount under this section with respect to the same unit of a covered outpatient drug purchased under the program under this section. Covered entities (and any entities acting on their behalf) shall be subject to determinations made by the Secretary to resolve such duplicate claims (and the Secretary may contract this function to the clearinghouse to make such determinations). In making such determinations, the Secretary shall investigate duplicate claims for rebates or discounts and require covered entities (and any entities acting on their behalf) to take action to avoid or pay refunds to reverse a duplicate claim. (IV) Refunds to manufacturers The Secretary shall be responsible for promptly refunding affected manufacturers of covered outpatient drugs for violations described in subclauses (I) and (II) of clause (i) and seeking subsequent repayment from covered entities or States (with respect to violations described in clause (i)(I)), or providers or dispensers (with respect to violations described in clause (i)(II)). Subject to the determination by the Secretary or clearinghouse under subclause (III), the covered entity (or entities) shall be liable to the manufacturer of the covered outpatient drug that is the subject of the violation described in clause (i)(IV) in an amount equal to the reduction in the price of the drug (as described in subsection (a)(1)) and shall repay such amount to such manufacturer within 60 days of receiving a notice described in clause (iii)(IV).. (b) Provision of drug claims data by medicaid; removal of duplicate claims (1) Medicaid Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended— (A) in paragraph (86), by striking and at the end; (B) in paragraph (87)(D), by striking the period and inserting; and; and (C) by inserting after paragraph (87) the following new paragraph: (88) provide for a mechanism for the State agency to furnish, and for the State agency to require each Medicaid managed care organization (as defined in section 1903(m)(1)(A)) to furnish, to the clearinghouse, in a machine-readable format, within 5 days following the date of claim payment, claims level data, including rebate file data, for covered outpatient drugs dispensed, furnished, or administered to individuals enrolled under a State plan (or a waiver of such plan) that includes, with respect to each dispense, furnishing, or administration of such a drug, the data elements described in subsection 340B(a)(5)(J)(iii) of the Public Health Service Act, and for the State agency to remove from any rebate request described in section 340B(d)(2)(C)(i)(I) of such Act any claim that is the subject of a notice submitted by such entity under section 340B(d)(2)(C)(iii)(III) of such Act.. (c) Provision of drug claims data by Medicare (1) Medicare Part B Section 1842 of the Social Security Act (42 U.S.C. 1395u) is amended by adding at the end the following: (v) Provision of drug claims data; mechanism To refund duplicated amounts Each Medicare administrative contractor shall furnish to the clearinghouse, in a machine-readable format, claims level data for covered outpatient drugs furnished or administered to individuals enrolled under this part that includes, with respect to each furnishing or administration of such a drug, the data elements described in section 340B(a)(5)(J)(iii) of the Public Health Service Act. Each Medicare administrative contractor shall furnish such data to the clearinghouse within 5 days following the date the claim for such drug is paid by the Medicare administrative contractor.. (2) Medicare Advantage organizations Section 1857(e) of the Social Security Act (42 U.S.C. 1395w–27(e)) is amended by adding at the end the following: (6) Provision of drug claims data; mechanism to refund duplicated amounts A contract under this part shall require a Medicare+Choice organization to furnish to the clearinghouse, in a machine-readable format, claims level data for covered outpatient drugs furnished or administered to individuals enrolled with the organization under this part that includes, with respect to each furnishing or administration of such a drug, the data elements described in section 340B(a)(5)(J)(iii) of the Public Health Service Act. Such contract shall require the Medicare+Choice organization to furnish such data to the clearinghouse within 5 days following the date the claim for such drug is paid by the Medicare+Choice organization.. (3) Prescription drug plans Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following: (9) Provision of drug claims data; mechanism to refund duplicated amounts A contract under this part shall require a PDP sponsor to furnish to the clearinghouse in a machine-readable format, claims level data for covered outpatient drugs dispensed to individuals enrolled in a prescription drug plan offered by such sponsor under this part that includes, with respect to each dispense of such drug, the data elements described in section 340B(a)(5)(J)(iii) of the Public Health Service Act. Such contract shall require a PDP sponsor to furnish such data to the clearinghouse within 5 days following the date the claim for such drug is paid by the PDP sponsor.. (4) MA–PDs Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following: (F) Provision of drug claims data; mechanism to refund duplicated amounts Section 1860D–12(b)(9)..