15 September (WNN) — The federal agency that operates Medicare is officially rolling back a rule change finalized earlier this year under former President Donald Trump that would have allowed the health program to cover the cost of “breakthrough” medical equipment .
In January, before President Joe Biden took office, the Centers for Medicare and Medicaid Services moved to implement the rule change as a measure to give American seniors quick access to “newer” medical equipment.
The rule was part of the agency’s “Unleashing Innovation and Patients Over Paperwork” initiative.
In recent months and under a new administration, however, CMS has decided that the proposed change is not in the best interests of Medicare recipients and could create a boon that wastes millions of dollars on equipment they don’t promise. .
“[The] The final rule established the Medicare coverage pathway to give Medicare beneficiaries rapid access to recently authorized medical devices designated by the Food and Drug Administration nationwide as a breakthrough. Under the last rule, [it] will result in four years of national Medicare coverage beginning with the date of FDA market authorization or within 2 years thereafter at the date chosen by the manufacturer,” CMS said in its official motion to repeal the rule, which was published Wednesday in the Federal Register. was posted in.
“We believe that the final … rule is not in the best interests of Medicare beneficiaries because the rule may provide coverage without sufficient evidence that the breakthrough device will be an appropriate and necessary treatment for patients who have a particular disease or condition.” The purpose of the device is to treat or diagnose.”
After Biden took office in January, the CMS delayed the rule from taking effect from March to December to allow more time to evaluate the change. It also made public comment on the rule before deciding to dismiss the rule outright.
A motion to reject the rule may be final no later than 30 days after public comment on the Federal Register. The medical device industry is expected to lobby heavily against the repeal.
Breakthrough medical devices receive early FDA authorization because they are considered to treat an unmet medical need. However, the devices sometimes provide no medical benefit and pose some safety risks.
“Our prior policies allowed the Medicare program to deny coverage for particular devices if we learned that a particular device might be harmful to Medicare beneficiaries,” the CMS proposal said.
In its proposal, CMS said there were “significant concerns” about the availability of clinical evidence for breakthrough devices when used on Medicare recipients, causing the program to pay unnecessary millions to cover unnecessary products. may have to.
The agency also expressed concerns about “the benefits or risks of these devices with respect to use in the Medicare population if coverage is obtained.”
In its decision, CMS said that the FDA sometimes relied on clinical device data that “does not necessarily include patients from the Medicare population,” and that the agency needs legislation to determine that. Requires which items are “reasonable and necessary”.
“The FDA and CMS operate under different laws that have different goals,” the agency said.
The Trump-era rule caused some pushback from the health insurance industry. Health Insurance Plans of America, a political advocacy and trade association, said it could potentially lead to “premature coverage of uncertified devices”.
The Advanced Medical Technology Association — or Advamed, a trade association for medical device manufacturers — applauded the rule when it was announced in January. It noted that the change would be a signal to the industry that the risk it takes to manufacture equipment is rewarded.