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340B Recertification Starts Feb. 10 for Most Centers and Grantees

Hospitals and family planning centers will go through process later this year 

January 30, 2014—All 340B covered entities other than hospitals and Title X family planning centers will need to recertify their eligibility for the drug discount program during a four-week period that begins Feb. 10, according to the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA). … [Read more...]

Texas Medicaid Moving Away From Acquisition Cost Billing for 340B Drugs

State would base reimbursement instead on its best estimate of 340B prices 

January 29, 2014—Texas Medicaid proposes to stop requiring health care providers to bill it for 340B drugs at actual acquisition cost (AAC) and to begin reimbursing providers instead based on its best estimate of a drug’s 340B price plus a dispensing fee. … [Read more...]

PhRMA, DOJ File Final Briefs in 340B Orphan Drug Case

Decision could come as soon as March 

January 23, 2014—The federal government and drugmakers have made their final arguments in the industry's lawsuit over the government regulation that lets certain rural and cancer hospitals access 340B discounts on orphan drugs when used for non-orphan indications. … [Read more...]

Congress Agrees to More than Double 340B Program Funding

OPA would be expected to implement long-delayed requirements 

January 14, 2014—House and Senate negotiators have signed off on a federal spending bill for the fiscal year that runs through September that would more than double the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs' (OPA) budget, including $6 million for new 340B program integrity efforts. … [Read more...]

Government Asks Court to Uphold 340B Orphan Drug Rule

PhRMA expected to make its final arguments by the end of this week 

January 14, 2014—If the federal government's legal defense of the 340B orphan drug regulation is successful, it might have to send Sherlock Holmes a thank-you note. … [Read more...]

Will 2014 Be the Year of the 340B Mega-Reg?

A rundown of what's in store for 340B in the coming year 

January 10, 2014—With just one exception, the federal government has always managed the 340B program without formal regulations, setting 340B's rules of the road instead through guidelines, policy releases, FAQs, and the like. … [Read more...]

HRSA Issues Last Two 340B Provider Audit Summaries for 2012

Plans to use results to develop best practices 

January 10, 2014—The Health Resources and Services Administration (HRSA) yesterday released the remaining two summaries of the 51 audits of 340B covered entities it performed in fiscal year 2012. HRSA's latest update also includes brief descriptions of how some audits were resolved. Many of the audits are still not final, however. … [Read more...]

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