BioCentury
ARTICLE | Politics & Policy

Aug. 2 P&P Quick Takes: Pediatric disease voucher guidance clarified, CMS proposes rule on hospital price transparency and draft guidance on clinical trial prac

August 2, 2019 11:44 PM UTC

Update to pediatric disease guidance clarifies what qualifies
FDA updated its draft guidance on rare pediatric disease priority review vouchers to include provisions from the Advancing Hope Act of 2016 and the 21st Century Cures Act to narrow the definition of "rare pediatric disease" to a condition with an entire prevalence of less than 200,000 in the U.S. and with more than 50% of patients living with the disease ages 0-18. The updated guidance also includes a restriction against receiving more than one Priority Review voucher for the same drug and a provision that the program would sunset on Sept. 30, 2022 unless reauthorized by Congress.

CMS issues proposed rule for hospital price transparency
CMS has issued a proposed rule requiring hospitals to make pricing information available to the public. The proposal, announced Tuesday by HHS Secretary Alex Azar, will require hospitals to disclose their negotiated prices to patients, which Azar said will boost competition and allow patients to shop among providers. The rule also mandates that hospitals make their standard charges public on the internet in a machine-readable file. Comments on the proposal are due Sept. 27...