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HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing Program
…its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over the 340B Drug Pricing Program conferred by section 7102(a) of the Patient Protection and Affordable…
HHS Will Delay 340B Final Rule Implementation to July 2018
On September 29, 2017, the Health Resources and Services Administration (“HRSA”) published, in the Federal Register, the Final Rule delaying the effective date regarding the methodology for calculating the 340B…
HHS Proposes Longer Delays to Implementation of the 340B Final Rule
On August 21, 2017, the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a Notice of…
HRSA Proposes to Collect Manufacturer Pricing Data Under 340B Program
…its proposal to collect pricing data from drug manufacturers under the 340B drug discount program. This Information Collection Request (“ICR”) is intended to implement § 340B(d)(1)(B)(i) of the Public Health…
U.S. District Court Agrees With PhRMA, Vacates HRSA 340B Orphan Drug Rule
…Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program when the drugs are purchased by certain covered entities. As described in our previous…
D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B Hospitals
…payments to hospitals that purchase drugs under the 340B Drug Discount Program. On Friday, July 31, the D.C. Circuit reversed that decision. Both courts applied the Chevron analysis for evaluating…
CMS Cuts in Drug Payment to Hospitals for 340B Drugs – Post Script
…the Court’s decision opened two options for CMS: continuing to implement its current ASP minus 22.5% rate for 340B drugs in 2021; or basing payment rates to hospitals for 340B…
New Developments in the Ongoing PhRMA v. HHS/HRSA Saga Over the Interpretation of the Exclusion of Orphan Drugs Under the 340B Program
…section 4340B(e) to balance the interests of orphan drug development and the expansion of the 340B Program to new entities.” Id. According to the Notice, the effective date for the…
340B Program Listens to Reason – No Need for Two AMP Calculations
…2007. (And if you don’t know this already, please contact Jeff Wasserstein or Alan Kirschenbaum right away!) Under the 340B program, manufacturers are required to offer certain PHS covered entities…
HRSA Releases Proposed Rule to Move Up Effective Date of 340B Final Rule
…340B ceiling price (including the so-called penny pricing policy) and civil monetary penalties (“CMPs”) for knowing and intentional overcharges of 340B covered entities. (See our original post regarding the Final…
Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case
In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities…
Fifth Delay for 340B Final Rule Implementation
…the 340B Drug Discount Program (“Substantive Final Rule”). The Substantive Final Rule, which was originally published on January 5, 2017, established the methodology for calculating the 340B ceiling price (including…
HRSA’s 340B Orphan Drug Exclusion Rule is Briefed for its Third Judicial Review
…that the statutory orphan drug exclusion from the 340B drug discount program, under which certain 340B covered entities are not eligible for 340B pricing for orphan drugs, only applies to…
HRSA’s 340B “Mega-Rule” Becomes Casualty of PhRMA Lawsuit Against Orphan Drug Rule
By Michelle L. Butler & Alan M. Kirschenbaum – On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew the 340B program “mega-rule” it had submitted for review…
Implementation of 340B Final Rule Postponed Until October 1, 2017
Today the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a rule delaying until October 1,…