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HRSA Releases New 340B Orphan Drug Rule; PhRMA Views Move As 'Power Play'

The Health Resources and Services Administration on Monday (July 21) issued an interpretive rule, expected by stakeholders, restating its view that orphan drugs used for non-orphan purposes are subject to 340B drug discounts -- a move the drug industry views as a “government power play” to get around a court ruling in PhRMA's favor and has asked the court to step in.

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The Supreme Court plans to hold oral arguments in mid-October for a case that will determine whether the U.S. Court of Appeals for the Federal Circuit can review a patent claim without considering district court findings.

A bipartisan group of seven senators is urging CMS to write a regulation implementing a law that makes it easier to determine how much money Medicare will be repaid when it covers medical expenses that are really the responsibility of private liability insurers.

FDA is defending its policies for sex-specific clinical trial data as lawmakers, women's health advocates and the American Medical Association ramp up pressure on the agency and sponsors to collect and communicate the information to consumers and physicians.

FDA Monday (July 21) unveiled key leadership positions as part of its reorganization of the Office of Generic Drugs, according to a memo from drug center Director Janet Woodcock.

Beneficiary advocates and hospice providers applaud CMS' overhaul of controversial drug prior-authorization guidelines for hospice beneficiaries, unveiled Friday (July 18), as a move that should help reduce access problems for terminally ill beneficiaries and providers.

The Office of the National Coordinator for Health Information Technology recently wrote to House Republicans that its planned health IT safety center will not be a regulatory body, essentially rebuffing lawmakers' concerns the office needs legislative authority to establish the center.

CMS Friday (July 18) awarded 14 five-year contracts to Quality Improvement Organizations that help providers improve the quality of care, marking the second step in CMS' overhaul of QIOs, which began in May.

CMS on Thursday (July 17) told five U.S. territories that their individual and small group market insurers do not have to comply with several major ACA reforms, including guaranteed availability, community rating, rate review and the medical loss ratio requirement.