Archives: Health Care Contracting

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Government Looking to Existing Procurement Vehicles to Stem Ebola Threat

As the U.S. government works to address the threat posed by the Ebola virus, one tool available to the Department of Health and Human Services (HHS) in this effort is a broad agency announcement (BAA) originally issued in 2009 as a means of accelerating the development of vaccines, therapeutics, and diagnostics to prevent and treat … Continue Reading

PhRMA Filed Suit Today Seeking to Invalidate the 340B Orphan Drug Exclusion Interpretative Rule

Today, Pharmaceutical Research and Manufacturers of America (“PhRMA”) filed a suit seeking to invalidate the 340B Orphan Drug Exclusion Interpretative Rule.  The same Health Resources and Services Administration (“HRSA”) policy in the “interpretive rule” was previously set forth in substance as a final regulation that was struck down by the U.S. District Court for the District of Columbia, about which we previously reported … Continue Reading

FDA Adopts Core NIST Framework in Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration recently became one of a number of federal agencies to adopt the National Institute of Standards and Technology’s (“NIST”) core cybersecurity framework.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  The final guidance sets forth … Continue Reading

HRSA Updates the Self-Disclosure Process for 340B Noncompliance

Earlier this month, HRSA set forth steps that providers should follow to make a “self-disclosure” when a “material breach” of 340B compliance has occurred.  HRSA noted that it is “working to standardize the self-disclosure process, and highlight best practices to assist covered entities in this effort.” During the annual covered entity recertification process, the 340B entity’s … Continue Reading

DoD Recently Released its Finalized RFP for its Healthcare Management System Modernization

On August 25, 2013, the Department of Defense (“DoD”) released its finalized solicitation to vendors who are interested in contending for the nearly $11 billion contract to provide an off-the-shelf electronic health record (EHR) software solution aimed at modernizing the DoD’s aging in-house systems, as well as the program support to foster interoperability with the … Continue Reading

Court of Federal Claims Stays Decision Requiring Commercial Item Contractor to Comply with Non-Commercial Practices

Contractors supplying commercial products and services to the U.S. Government under the Federal Supply Schedule (“FSS”) or General Services Administration (“GSA”) Schedules program may be required to comply with non-commercial requirements. Until recently, it was thought that rules in Part 12 of the Federal Acquisition Regulation (“FAR”) applicable to commercial item purchases—rules that restricted agencies … Continue Reading

Judge Requires PhRMA To Initiate New 340B Orphan Drug Lawsuit to Challenge Interpretive Rule

A Washington, D.C., federal judge has declined requests from Pharmaceutical Research and Manufacturers of America(“PhRMA”) to invalidate a new interpretive rule applicable to orphan drugs in the 340B drug discount program, saying the trade group must file a new complaint in order to proceed. Last week, the D.C. District Court ruled that PhRMA must bring … Continue Reading
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