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Sept. 15 (UPI) -- The federal agency that operates Medicare is officially going back on a rule change it finalized earlier this year under former President Donald Trump that would have allowed the health program to cover the costs of "breakthrough" medical devices. 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 quicker access to "innovative" medical devices.
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The rule was part of the agency's "Unleashing Innovation and Patients Over Paperwork" initiative.
In recent months and under a new administration, however, the CMS has decided that the proposed change is not in the best interests of Medicare recipients and could create a boondoggle that wastes millions of dollars on devices that do not deliver what they promise.
"[The] final rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to recently market authorized medical devices designated as breakthrough by the Food and Drug Administration. Under the final rule, [it] would result in four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter," the CMS said in its official motion to repeal the rule, which was posted to the Federal Register on Wednesday.
"We believe that the finalized ... rule is not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence that the breakthrough device would be a reasonable and necessary treatment for patients that have the particular disease or condition that the device is intended 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 for evaluation of the change. It also took public comment on the rule before deciding that the rule should be rejected entirely.
The proposal to reject the rule could become final after 30 days of public comment on the Federal Register. The medical device industry is expected to lobby heavily against the repeal.
Breakthrough medical devices receive expedited FDA authorization because they are considered to treat an unmet medical need. The devices, however, sometimes do not offer any medical benefit and pose certain safety risks.
"Our prior policies permitted the Medicare program to deny coverage for particular devices if we learned that a particular device may be harmful to Medicare beneficiaries," the CMS motion added.
In its proposal, the CMS said it had "significant concerns" about the availability of clinical evidence for breakthrough devices when used on Medicare recipients, which could lead the program to pay unnecessary millions to cover unnecessary products.
The agency also expressed concern about "the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage."
In its decision, the CMS said the FDA occasionally relies on clinical device data that don't "necessarily include patients from the Medicare population," and the agency is required by law to determine which items are "reasonable and necessary."
"FDA and CMS act under different statutes that have different goals," the agency said.
The Trump-era rule drew some pushback from the health insurance industry. America's Health Insurance Plans, a political advocacy and trade association, said it could have potentially resulted in "premature coverage of unproven 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 have been a signal to the industry that risks it takes to manufacture devices are rewarded.
