HRSA issues interpretive rule on orphan drug exclusion

HRSA issues interpretive rule on orphan drug exclusion

July 28th, 2014
Last week, the Health Resources and Services Administration (HRSA) issued an interpretive rule clarifying their position that manufacturers should continue to extend 340B prices for orphan drugs when these drugs are purchased and used by free-standing cancer hospitals (CAN), sole community providers (SCH), rural referral centers (RRC) and critical access hospitals (CAH) for non-orphan indications.

Get ready for 340B recertification!

Get ready for 340B recertification!

July 18th, 2014
The first communication regarding HRSA’s third annual mandatory recertification process for participating 340B hospitals will be sent to the authorizing official for each hospital around Aug. 1.

HRSA updates audit procedures

HRSA updates audit procedures

July 11th, 2014
As the Health Resources and Services Administration (HRSA) continues to enhance their role in 340B Program oversight, they have made three changes that will affect covered entities. While the overall process remains mostly unchanged, recently-announced enhancements to post-audit procedures will impact how covered entities learn about and respond to audit findings.

OPA registration now open!

OPA registration now open!

July 10th, 2014
All new covered entities, outpatient facilities, and contract pharmacies can register now through July 15 for an effective start date of Oct. 1. The OPA encourages organizations to register early to allow time to resubmit if they determine that the information provided is incorrect or incomplete.

US district judge invalidates orphan drug regulation

US district judge invalidates orphan drug regulation

May 29th, 2014
A federal judge ruled Friday that the Department of Health and Human Services (HHS) has no authority to make new regulations regarding the […]

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SentryDS.com is your source for all news and events related to healthcare information technology, Sentry Data Systems and its products.

Contributors

Travis Leonardi, RPh., C.P.
President, CEO
William D. Kirsh DO, MPH
Chief Medical Officer
Lidia Rodriguez-Hupp
SVP and 340B Compliance Officer
Dawn C. DeAngelo
Chief Pharmacy Officer

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