The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more
Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more
10/17/2014
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Ambulance Providers ,
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CMP Law ,
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Proposed Regulation ,
Safe Harbors