The Parallel Review Paradox

If the parallel review was expected to bring them faster access to the gravy train, they'd be for it.

From https://www.cms.gov/DeterminationProcess/ : "National coverage determinations (NCDs) are made through an evidence-based process, with opportunities for public participation. In some cases, CMS' own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)."

The problem for industry is obvious. Public input is permitted, and an outside technology assessment might be involved. This could actually uncover inappropriate approvals in the expedited 510 k approval-for-pay system which has just been announced. Clinical data might be requested, for devices that are not really "substantially equivalent" to some already approved device.

The sense of entitlement in this industry association (your link) is amazing. What other industry would imagine they had the right to strike down "Anything that interferes with the autonomy of med-tech companies to choose their own regulatory pathway.." Yikes.