A final regulation implementing the 340B Drug Discount Program has been caught in the regulatory freeze. In the waning days of the Obama Administration, the Health Resources and Services Administration…

…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,…

…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…

…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…

…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…

…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…

…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…

…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…

…November 2017 final rule reducing the Part B payment to hospital outpatient departments for separately payable drugs purchased under the 340B Drug Discount Program from ASP plus 6% to ASP…

…Medicaid Drug Rebate Program, the 340B drug discount program, the Veterans Affairs drug discount program, the TRICARE retail refund program, and the Medicare Part D Coverage Gap Discount Program, are…

…and format of state invoices, frequency of invoicing, and other terms and conditions will be negotiated between the manufacturer and the state. Ceiling prices under the 340B Drug Discount program…

…services in underserved areas, currently purchase these drugs (among many others) at a statutory discount under the 340B Drug Discount Program. However, FQHCs are not currently required to provide these…