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Your search for “340b” returned the following results.
…to (1) add additional categories of health care facilities to the categories of 340B Covered Entities eligible to purchase drugs at discounted prices pursuant to the 340B program, and (2)…
…its 340B program ceiling price and civil monetary penalties regulation from July 1 to January 1, 2019. After reviewing comments on the proposal, many of which were critical of the…
…covered entities under the 340B Drug Discount Program. To recap briefly, the rule had provided that the orphan drug exclusion is applicable only to orphan drugs when used for the…
…with the Section 340B program’s objectives.” And later, “the section 340B program was created to give covered entities discounts so they could ‘stretch scarce Federal resources as far as possible,…
…14) 340B sales and best price: All prices to 340B covered entities are excluded from best price, not just “prices charged under the 340B program,” as proposed. (P. 15) “Original…
…a report the OIG issued simultaneously regarding noncompliance by drug manufacturers with AMP reporting requirements. The Medicaid Drug Rebate Program and the 340B program both rely on timely and accurate…
…January 2011, when the methodology would be revised to 130% of weighted AMPs of the multiple source drugs. Expansion of 340B Program (§§ 2501-2502): The list of covered entities eligible…
…of the Mark that would impose Medicaid rebates on drugs dispensed by Medicaid managed care organizations was amended to exclude drugs purchased through the 340B program. (p. 14) The provision…
…drugs. • Biosimilar approval: The President’s proposal adopts from both bills a new approval pathway for biosimilars. • 340B program expansion: A cryptic reference to extending drug discounts to “hospitals and…
…2017 HHS published in the Federal Register a final rule implementing the 340B Drug Pricing Program Ceiling Price policy and Civil Monetary Penalty (“CMP”) standards, including the knowledge requirement related…
…D context, HHS OIG plans to assess “Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies” and billing for topical compounded drugs. HHS OIG also plans to review…
…In a prior post, we commented that, in enacting previous government discount programs in the early 1990s (the Medicaid Drug Rebate Program, the 340B drug discount program, and the VA…
…the Senate bill contains major changes to the Medicaid Rebate Program, Medicaid drug reimbursement, Medicare Part D, the 340B Drug Discount Program, and the Federal Food, Drug, and Cosmetic Act,…
…drugs increased to 22.1% of AMP and rebates increased for new formulations (§ 1742) Rebates required for drugs dispensed to Medicaid managed care enrollees (§ 1743) 340B Program Program expanded…
…and lower ceiling prices under the 340B drug discount program. Comments on this ANPRM are due to CMS no later than 5:00 pm on December 31, 2018. We will be…