The Food and Drug Administration\u2019s breakthrough device program continues to expand at a breakneck pace. Established to grease the wheels of regulatory conversation and submission for innovative devices that promise to help patients with debilitating disease, the FDA has stamped 1,176 products with the breakthrough label \u2014 and so far authorized 160 of them to enter the market.<\/p>\n
As those 160 devices enter doctors\u2019 offices and surgical suites, their implications for health care costs are expanding. In bipartisan bills before Congress, breakthrough devices are proposed to receive four years of automatic Medicare coverage. It\u2019s an idea that has come and gone since the previous Trump administration, thanks in part to objections that a \u201cbreakthrough\u201d label doesn\u2019t guarantee better outcomes for patients than existing options. Now, health policy researchers are raising the alarm again.<\/p>\n
With the regulatory flexibilities the FDA leverages when authorizing breakthrough devices, \u201cwe\u2019re concerned that this will ultimately lead to low value or potentially harmful spending and utilization of devices that come to market with less rigorous evidence to support their use,\u201d said physician Vinay Rathi, a health policy researcher at Ohio State University.<\/p>\n
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