November 29, 2021
Life Sciences
  • A bipartisan group of 61 House members scolded the Biden administration for repealing a rule that would have required Medicare to pay for any medical device deemed as a “breakthrough” by the FDA. The CMS said that although the FDA reviews breakthrough devices for safety and effectiveness, “there is often limited evidence regarding whether the device is clinically beneficial to Medicare patients.” According to the representatives, the decision “may delay future innovative medical devices and diagnostic tools,” and the agency should “retain the crucial components” in a future rule. (Article here)