FDA and Medicare to test joint decision-making on medical products

The FDA announced Thursday that it is beginning a pilot project with Medicare officials in an effort to get new medical products covered sooner for the nation's 45 million senior citizens. Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market," Reuters reported. The actions could have an impact on people who are not on Medicare. "Private insurers often weigh [Medicare's] coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace" (Heavey, 9/16).

Dow Jones/The Wall Street Journal: Companies have raised concerns "that getting products to consumers can be a slow process even after a company wins FDA approval because the company must then undergo a second" review by Medicare officials "to address health insurance coverage and payment issues. 'A positive coverage decision after a long time lag following FDA approval or clearance can delay consumer access to new medical products,' the FDA said in its notice, adding that timely access to new medical technologies is a significant issue in the delivery of health care" (Randal, 9/16).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.