1396r–8(k)(5)), and other relevant stakeholders, including health care providers, regarding implementation of the amendment made by subsection (a). This tool helps you identify your pills by color, shape and markings. “(A) IN GENERAL.—The term ‘discounted price’ means 80 percent of the negotiated price of the applicable drug of a manufacturer. “(4) JUDICIAL REVIEW.—There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of the determination of the rebate amount under subsection (b), including with respect to a subsequently approved drug pursuant to subsection (c), including—.
(D) TRADE SECRETS AND CONFIDENTIAL INFORMATION.—No information discussed as a part of the public meeting under this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.

Sec. “(ii) An unqualified audit opinion that renders the audit closed. “(3) INSTALLMENT-BASED PAYMENT STRUCTURE.—.

Such study shall include an analysis of—, (1) differences in program structures and payment methods for drugs and biologicals covered under such parts B and D, including effects of such a shift on program spending, beneficiary cost-sharing liability, and utilization management techniques for such drugs and biologicals; and.

“(C) FFP FOR PAYMENTS UNDER RISK-SHARING VALUE-BASED PAYMENT AGREEMENTS.—Federal financial participation shall be available under this title for any payment made by a State to a manufacturer for a covered outpatient drug under a risk-sharing value-based payment agreement in accordance with this subsection, except that no Federal financial participation shall be available for any payment made by a State to a manufacturer under such an agreement on and after the effective date of a disapproval of such agreement by the Secretary. 129. Pharmaceutical companies fiercely oppose that legislation. “(iv) such recommendations to Congress as the Secretary deems appropriate. Patient consultation in Medicare national and local coverage

147. Sec. taxpayers, and for other purposes.

“(v) APPROPRIATIONS.—Out of any funds in the Treasury not otherwise appropriated, there is appropriated to the Secretary $2,000,000 for fiscal year 2020 and each fiscal year thereafter to carry out this subparagraph.”. with respect to the coding, coverage, and payment of novel medical products described in subsection (c). “(C) WITHDRAWAL OF APPROVAL.—In the case of a covered outpatient drug that is the subject of a risk-sharing value-based agreement between a State and a manufacturer under this subsection, including a drug approved in accordance with section 506(c) of the Federal Food, Drug, and Cosmetic Act, and such drug is the subject of an application that has been withdrawn by the Secretary, the State plan shall not be liable for any remaining payment that is owed under the agreement. It would also penalize pharmaceutical companies if the price of their drugs rise faster than inflation. SEC. GAO study on increases to Medicare and Medicaid spending due to copayment coupons and other patient assistance programs.

manufacturer third-party reimbursement hubs on health care providers who In neither 2017 nor 2018 was there any significant movement in Congress on prescription drug pricing. Payment for biosimilar biological products during initial period. “(C) Total expenditures of the manufacturer on—. 1396r–8(d)(4)) is amended to read as follows: “(A) (i) The formulary is developed and reviewed by a pharmacy and therapeutics committee consisting of physicians, pharmacists, and other appropriate individuals appointed by the Governor of the State. “(3) DETERMINATION OF INFLATION-ADJUSTED PRICE.—, “(A) IN GENERAL.—The inflation-adjusted price determined under this paragraph for a rebate period, with respect to each dosage form and strength of a rebatable covered part D drug, is—, “(i) the benchmark unit-weighted price determined under subparagraph (B) for the rebate period; increased by. 1395w–104), as amended by section 125, is amended by adding at the end the following new subsection: “(p) Reporting potential fraud, waste, and abuse.—Beginning January 1, 2021, the PDP sponsor of a prescription drug plan shall report to the Secretary, as specified by the Secretary—, “(1) any substantiated or suspicious activities (as defined by the Secretary) with respect to the program under this part as it relates to fraud, waste, and abuse; and. With written report No. “(iii) The membership of the pharmacy and therapeutics committee—, “(I) includes at least 1 actively practicing physician and at least 1 actively practicing pharmacist, each of whom—, “(aa) is independent and free of conflict with respect to manufacturers and Medicaid participating plans or subcontractors, including pharmacy benefit managers; and, “(bb) has expertise in the care of 1 or more Medicaid-specific populations such as elderly or disabled individuals, children with complex medical needs, or low-income individuals with chronic illnesses and.
(i) the status of the drug and medical device development pipeline related to the availability of novel medical products; (ii) the anticipated expertise necessary to review the safety and effectiveness of such products at the Food and Drug Administration and current gaps in such expertise, if any; (iii) the expertise necessary to make coding, coverage, and payment decisions with respect to such products within the Centers for Medicare & Medicaid Services, and current gaps in such expertise, if any; (iv) trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act pursuant to section 1862(a)(1)(A) of such Act (42 U.S.C. (II) by adding at the end the following new sentence: “The Secretary shall continue to calculate the dollar amounts specified in clause (i)(I)(aa), including with the adjustment under this clause, after 2021 for purposes of section 1860D–14(a)(1)(D)(iii).”; (I) in subclause (V), by striking “or” at the end; (aa) by striking “for a subsequent year” and inserting “for 2021”; and, (bb) by striking the period at the end and inserting a semicolon; and. Addition of new measures based on access to biosimilar biological products to the 5-star rating

1395w–101 et seq.) “(bb) pursue any other remedy that would be available if the manufacturer had failed to pay required rebates under this section. (B) recommendations for administrative or legislative action to improve the effectiveness of, and reduce costs for, covered outpatient drugs under Medicaid while ensuring timely beneficiary access to medically necessary covered outpatient drugs. In 2017, the pharmaceutical industry made more than twice as much money in the U.S. – $453 billion – than in all European countries combined. Debated in Committee This Thursday, Legislation Modernizes, Reg. “(II) the total number of units of such dosage form and strength dispensed on July 1, 2019.

Inclusion of value of coupons in determination of average sales price for drugs and biologicals

SEC. GAO study and report on average sales price. 108. [externalActionCode] => 14000 The decision to submit and timing of a request to enter into a proposed risk-sharing value-based payment agreement shall remain solely within the discretion of the State and shall only be effective upon Secretarial approval as required under this subsection. “(7) To assist the Department of Justice to carry out its antitrust authorities, including reviewing proposed mergers in the prescription drug sector.”; and. 1150C. 110. “(II) TERMINATION FOR FAILURE TO PAY.—The failure of a manufacturer to make repayments required under subclause (I) in a timely manner shall result in immediate termination of all risk-sharing value-based agreements to which the manufacturer is a party. SEC. “(i) IN GENERAL.—The Secretary shall impose a civil money penalty on a manufacturer that fails to comply with the requirements under paragraph (1)(B) with respect to providing a rebate for a rebatable drug for a rebate period for each such failure in an amount equal to the sum of—, “(I) the rebate amount specified pursuant to paragraph (3) for such drug for such rebate period; and.

(2) by adding at the end the following new subsection: “(o) Real-time benefit information.— “(1) IN GENERAL.—After the Secretary has adopted a standard under paragraph (3) for electronic real-time benefit tools, and at a time determined appropriate by the Secretary, a PDP sponsor of a prescription drug plan shall implement one or more of such tools that meet the requirements described in paragraph (2). 06/27/2019 Read twice and referred to the Committee on Finance. “(ii) any charge to the patient for the use of such coupon. “(B) TRANSITION RULE FOR INFORMATION IN 2022.—Notwithstanding subparagraph (A), the Secretary may, for each rebatable covered part D drug, delay the timeframe for reporting the information and rebate amount described in clauses (i), (ii), (iii), and (iv) of such subparagraph for rebate periods in 2022 until not later than December 31, 2023. innovative medicines that save and improve the quality of millions of American paid into the system their entire life shouldn’t have to cut pills in half to 1396r–8(b)(3)) is amended to read as follows: “(B) AUDITS AND SURVEYS OF MANUFACTURER PRICE AND DRUG PRODUCT INFORMATION.—. (D) identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of such Act (42 U.S.C. 1396b(m)(2)(A)(xiii)) is amended—. “(4) APPLICATION TO NEW DRUGS.—In the case of a rebatable drug first approved or licensed by the Food and Drug Administration after July 1, 2019, the following shall apply: “(A) DURING INITIAL PERIOD.—For quarters during the initial period in which the payment amount for such drug is determined using the methodology described in subsection (c)(4)—. With written report No. AARP is a nonprofit, nonpartisan organization that empowers people to choose how they live as they age. “(iv) At the option of the State, the State’s drug use review board established under subsection (g)(3) may serve as the pharmacy and therapeutics committee provided the State ensures that such board meets the requirements of clauses (ii) and (iii).

1396r–8) and drug utilization review activities and requirements under section 1932(i) of such Act (42 U.S.C. (1) IN GENERAL.—The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct a study on the influence of pharmaceutical manufacturer distribution models that provide third-party reimbursement hub services on health care providers who prescribe the manufacturer’s drugs and biologicals, including for Medicare part D beneficiaries. (a) Audit of manufacturer price and drug product information.—. The top five “(I) IN GENERAL.—If the average manufacturer price with respect to each dosage form and strength of a single source drug or an innovator multiple source drug increases on or after October 1, 2021, and such increased average manufacturer price exceeds the inflation-adjusted average manufacturer price determined with respect to such drug under subclause (II) for the rebate period, clause (i) shall not apply and there shall be no limitation on the sum of the amounts applied under paragraph (1)(A)(ii) and this paragraph for the rebate period with respect to each dosage form and strength of the single source drug or innovator multiple source drug. “(e) Data files.—The Secretary shall make available the underlying data for each dashboard established under subsection (a) in a machine-readable format.”.


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