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Medicare Says, Accessing FDA-Approved Medical Devices Needs OK

Getting new Medical Devices protected by public and private health insurance can be a never-ending bureaucratic nightmare. Medical innovations considered “safe and effective” by the Food and Drug Administration – the gold standard for drug and device regulation around the world – aren’t always protected by the Centers for Medicare & Medicaid Services, which allows companies to prove their product is “reasonable and necessary.”

Unlike medications, which CMS usually protects immediately after FDA approval, many FDA approved or cleared Medical diagnostics and devices are only available to seniors if they engage in a CMS-approved clinical trial. These trials can take years to complete, requiring additional data and a lengthy administrative process to assess coverage requirements.

In the meantime, Medicare recipients are denied potentially lifesaving Medical treatments. A new policy scheduled to take effect in mid-March would have required seniors and their physicians to determine whether they needed those devices. Still, when the Biden administration took office, it was placed on hold and other pending regulations.

The new Medicare Coverage of Innovative Technology policy, which has been postponed until May 15 pending regulatory review, takes advantage of existing FDA legal authority under the Breakthrough Devices Program to select a small number of promising medical devices innovations and provide them with a limited duration of assured Medicare coverage — beginning the day after FDA approval.

The revised policy would be a significant step forward in allowing Medicare recipients to make informed healthcare decisions. The FDA has approved, certified, or cleared at least 26 breakthrough diagnostics and devices as of now.

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