CMS Rule Aims To Quickly Cover All ‘Breakthrough’ Medical Devices
If the proposal is approved, the FDA would clear these devices quickly because they treat an unmet medical need. Other medicare news is on changes Joe Biden wants to make; and Medicaid news is from Colorado and Mississippi, as well.
Modern Healthcare:
Medicare Proposes Coverage Of 'Breakthough' Medical Devices
CMS is proposing that Medicare cover all medical devices designated by the Food and Drug Administration as a "breakthrough" technology.The proposed rule, released Monday, is in response to an executive order by President Donald Trump in late 2019 that tasked CMS with streamlining coverage for breakthrough medical devices. Manufacturers can voluntarily participate in FDA's Breakthrough Devices Program to secure quicker review of their devices. The program is only open to devices that provide effective treatment or diagnosis of a life-threatening or debilitating condition and they must use a breakthrough technology, offer significant advantages compared to existing alternatives or have no approved clearance currently in existence. (Castellucci, 8/31)
FierceHealthcare:
CMS Rule Aims To Reduce Lag Time Between FDA Approval And Medicare Coverage Of New Devices
The proposed rule released Monday would tackle the lag time between when a new device is approved or cleared by the Food and Drug Administration and get covered by Medicare, a time the administration refers to as the “valley of death” for innovative products. The rule would create a new, faster Medicare coverage process for devices the FDA gives a “breakthrough” designation to. Such devices are cleared at a faster rate by the agency because they treat an unmet medical need. (King, 8/31)
Also —
The Motley Fool:
2 Big Medicare Changes Joe Biden Wants To Make
[Democrat Joe] Biden, who's been leading in virtually all polling over Trump, has big plans for Medicare. In particular, he's highlighted two changes he's eager to make if he wins the election. Interestingly, though, neither of these changes appear to tackle Medicare's most pressing concern: the HI Trust funding shortfall. (Williams, 8/30)
AP:
After Victories, Medicaid Expansion Revisited In Mississippi
After voters expanded Medicaid in conservative states like Missouri and Oklahoma, health care advocates are renewing a push for expansion in Mississippi and other Southern states where Republican leaders have long been opposed. They say the changing tide has followed rising income inequality, joblessness and pressure from hospitals in economic turmoil — issues exacerbated by the coronavirus pandemic. (Willingham, 8/30)
Denver Post:
Colorado's Medicaid Numbers Are Rising More Slowly Than Expected, But State Is On Guard For A Late Surge
Colorado’s Medicaid numbers aren’t surging as fast as predicted amid COVID-fueled joblessness, but the program’s administrators aren’t relaxing yet, since federal decisions and the economy’s unpredictable trajectory could still force them to come up with additional funding. The Colorado Department of Health Care Policy and Financing had estimated about 500,000 people in the state could enroll in Medicaid by December. The Colorado Health Institute had estimated the number of new members could be closer to 563,000, which would mean about one-third of the state’s residents would be covered by Medicaid. (Wingerter, 8/31)
