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HRSA Tells 50-Plus Drug Makers To Refund 340B Hospitals Overcharged For Orphan Drugs

The Health Resources and Services Administration has told more than 50 drug manufacturers to refund 340B hospitals for certain orphan drugs charged at non-discounted prices, complaining the companies did not follow the agency's controversial orphan drug policy that has been the subject of two drug industry court challenges.

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The National Community Pharmacists Association said Tuesday (Oct. 21) it is pushing for action during the lame-duck session on two House bills -- one to allow any willing pharmacy to participate in Medicare Part D preferred pharmacy networks in medically underserved areas and one designed to control skyrocketing generic drug prices -- that the advocacy group for independent pharmacies and small, regional pharmacy chains has been aggressively backing.

The Medicare Rights Center is asking CMS to make improvements to Medicare Advantage plans' appeals processes by giving beneficiaries more information and auditing plans more often, as the beneficiary advocates say managing coverage denials and appeals is a consistent concern for MA beneficiaries.

Congress could allow for binding arbitration to help plans negotiate lower prices for unique specialty drugs, Harvard professors wrote in a January 2008 Health Affairs article that is getting new attention in light of the $94,500 price of a 12-week course of the newly approved hepatitis C drug Harvoni.

Wall Street firm JP Morgan says in a recent “managed care” memo that California's updated enrollment figures provide insight into the number of people who will churn off of exchange coverage and indicate that the impact may not be as negative as expected.

Companies developing biologics want FDA to begin the process of determining biologic exclusivity earlier than it has planned in recent draft guidance and assert that the agency has gone beyond its statutory mandate in asking them to prove their product's exclusivity instead of automatically granting it.

The House Energy and Commerce Committee is looking at speeding medical product development process by streamlining FDA reviews, providing added exclusivity, centralizing Institutional Review Board reviews, targeting NIH grants and leveraging data, committee staff and a key lawmaker said this week as the panel moves toward a January issuance of a discussion draft bill for its 21st Century Cures initiative.

Stakeholders disagree on how much risk information should be required on informed consent sheets provided to patients enrolling in clinical trials on investigational products, with a public interest group urging FDA to require more information on risks related to animal models while some other stakeholders say the agency already wants too much information included.

UnitedHealth Group, which entered only a handful of health insurance exchanges in year one, is on track to participate in about about two dozen states in 2015, United executives said in an earnings call with investors.