Posted on March 9, 2010 by Debra A. McCurdy

340B Drug Program Contract Pharmacy Service Guidance

On March 5, 2010, the Health Resources and Services Administration (HRSA) published a final notice on 340B drug pricing program contract pharmacy services. The notice announces the availability of final guidelines regarding the utilization of multiple contract pharmacies and suggested contract pharmacy provisions, which previously had been limited to the “Alternative Methods Demonstration Project” program. These final guidelines, which are effective April 5, 2010, replace all previous 340B program guidance documents addressing non-network contract pharmacy services.  Additional analysis is available on our Life Sciences Legal Update blog.  

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Posted on January 28, 2010 by Debra A. McCurdy

National Practitioner Data Bank Adverse Action Reporting Final Rule

On January 28, 2010, the Health Resources and Services Administration (HRSA) published a final rule updating the regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners. The rule implements statutory provisions requiring each state to have in effect a system of reporting disciplinary licensure actions taken against all licensed health care practitioners and entities. It also requires states to report any negative action or finding that a peer review organization, private accreditation entity, or a state has concluded against a health care practitioner or entity. The rule is effective March 1, 2010.

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Posted on September 4, 2009 by Debra A. McCurdy

340B Drug Pricing Program and Children's Hospitals

The Health Resources and Services Administration (HRSA) published a final notice on September 1, 2009 on how children’s hospitals that meet certain requirements may participate in the “340B” program, under which prescription drug manufacturers provide discounted drugs to certain eligible entities. The notice also informs discusses the obligation of manufacturers to provide the statutorily-mandated discount to those children’s hospitals. The notice is effective September 1, 2009.

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