CMS Tweaks Med Device Approvals
Oct 5, 2018 13:40:09 GMT
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Post by icemandios on Oct 5, 2018 13:40:09 GMT
CMS eases approval of medical devices
The CMS has tweaked one of its coverage processes to ease access to medical devices.
There are two Medicare coverage types, one that allows national coverage and one that allows Medicare contractors to pay for services or items on a local or regional basis. The agency has modified the latter.
"It's no secret that the government often moves more slowly than private industry—some of our payment policies haven't been updated in decades," CMS Administrator Seema Verma said in a statement. "This means that patients may experience unnecessary gaps between FDA approval of a technology and Medicare paying for the technology."
The agency is responding to a requirement in the 21st Century Cures Act for more transparency in the local coverage determination process.
As part of the change, Medicare contractors must ask devicemakers to all submit the same clinical evidence. Currently, that can differ by region.
There are 12 contractors across the country that process Medicare fee-for-service claims for nearly 68% of the total population, or 38.5 million Medicare beneficiaries. The MACs oversee more than 1.5 million healthcare providers enrolled in Medicare and collectively process more than 1.2 billion Medicare claims every year.
The contractors from now on must also ensure that there are medical providers and beneficiary representatives that participate on advisory committees which weigh in on local coverage decisions and that those meetings are open to the public.
By Virgil Dickson | October 3, 2018
There are two Medicare coverage types, one that allows national coverage and one that allows Medicare contractors to pay for services or items on a local or regional basis. The agency has modified the latter.
"It's no secret that the government often moves more slowly than private industry—some of our payment policies haven't been updated in decades," CMS Administrator Seema Verma said in a statement. "This means that patients may experience unnecessary gaps between FDA approval of a technology and Medicare paying for the technology."
The agency is responding to a requirement in the 21st Century Cures Act for more transparency in the local coverage determination process.
As part of the change, Medicare contractors must ask devicemakers to all submit the same clinical evidence. Currently, that can differ by region.
There are 12 contractors across the country that process Medicare fee-for-service claims for nearly 68% of the total population, or 38.5 million Medicare beneficiaries. The MACs oversee more than 1.5 million healthcare providers enrolled in Medicare and collectively process more than 1.2 billion Medicare claims every year.
The contractors from now on must also ensure that there are medical providers and beneficiary representatives that participate on advisory committees which weigh in on local coverage decisions and that those meetings are open to the public.