Drugs

Breakthrough Products Coverage Bill Introduced

Sen. Dan Coats (R-IN) has introduced S. 2998, the Ensuring Patient Access to Critical Breakthrough Products Act, to “establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.” In a statement, the senator says that “researchers and entrepreneurs … regularly come up with groundbreaking new treatments for some of our worst illnesses, only to encounter government regulations that prevent many patients from receiving potentially life-saving care. This legislation would streamline the current process, allowing Medicare patients to receive new treatment while also ensuring proper safety and quality regulations are met.”

He says that currently, once a new technology passes the FDA expedited review program, it may take up to three years to navigate the HHS Centers for Medicare and Medicaid Services (CMS) coverage and reimbursement process. Thus, he says, years could pass before Medicare beneficiaries are able to access the approved medical breakthroughs.

Under the bill, new treatments approved by FDA would be given a three-year temporary coverage period during which they would receive a guaranteed level of payment. CMS could specify what additional data would be needed to continue coverage after the three-year period under its statutory “reasonable and necessary” standard.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome