Breakthrough medical devices will get faster insurance coverage in the US under a new government program that coordinates coverage with the approval process, streamlining one of the biggest hurdles for patient access and industry sales.
The Centers for Medicare and Medicaid Services and the US Food and Drug Administration unveiled the new coverage pathway on Thursday, saying it could result in insurance coverage of the most innovative devices in as little as two months, down from more than a year. The Regulatory Alignment for Predictable and Immediate Device, or Rapid, applies to breakthrough technology that addresses unmet medical needs and already undergoes a quicker FDA review. It aligns FDA reviews and CMS coverage, bringing the insurance component in earlier during the development process.
“The American people deserve timely access to meaningful treatments without red tape or high costs,” FDA Commissioner Marty Makary said in a statement.
The new program must go through a regulatory process, including two months of public comment, before it is implemented.
The types of devices that the agencies would consider for the program include artificial heart valves, devices that treat heart rhythms or implants that stimulate nerves to treat disease, said John Brooks, CMS chief policy and regulatory officer. Forty devices are already eligible for the program and another 20 could potentially participate, according to the agency.
Those devices are typically developed by the biggest medical technology companies, including Medtronic Plc, Boston Scientific Corp., Abbott Laboratories and others.
One of the biggest hurdles for medical device companies is the length of time it takes to get insurance coverage for their products, something that can add years to the development process. And it’s often scattershot, with patients in some areas getting access while others still wait.
The issue is the so-called National Coverage Determination, which determines whether the government’s Medicare and Medicaid programs will pay for the products. While it doesn’t formally bind private insurers, many do follow the government’s rulings.
Photo: An employee works on the stent graft production line at a Medtronic Inc. assembly plant. Photographer: David Maung/Bloomberg
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