Wednesday, September 12, 2018

Brief Blog: FDA & Payers: Does a New Press Release Make It New?

In February 2016, FDA published a notice in the Federal Register announcing a program through which it invited commercial payers to participate in helping developers understand the differing requirements of payers for coverage decisions and FDA for regulatory decisions.  I covered this and provided links here

Now in September 2018, there are a spate of very similar articles about FDA gearing up its integrated program of communications jointly with commercial payers and FDA.   See an article in Health Payer Intelligence here.   The flurry of "new-news" is stimulated by a September 5, 2018, speech by Commissioner Gottlieb at the Medical Device Innovation Consortium, here.   The full speech highlights other FDA innovations related to devices besides the payer consortium channel.

Does "new" rhyme with "deja-vu?"   It happens. (In fairness to my deja-vu assertion, in a blog Gottlieb does mention the PPP or Private Payer Program dates to 2016). 

73 Inquiries Into CMS-FDA Parallel Review

In a September 2018 blog, here, Dr. Gottlieb notes that the agency has logged 73 inquires about FDA-CMS parallel review (towards NCDs) and received 36 formal applications for the same, although only 2 NCDs have resulted (Exact Sciences Cologuard and FMI F1 CDx).   

CareFirst HealthWorx; CareFirst and FDA

Two payers highlighted by Gottlieb are United Healthcare and CareFirst, the latter known for its entrepreneurial investment program HealthWorx.   Besides UHC and CareFirst, other associations to PPP have included BCBSA, Duke, ECRI, Humana, Kaiser, and NICE.


Company/Payer HEOR communications

A different topic also involves FDA, regulatory guidance, and payers.  In February 2017, FDA issued a draft guidance on communications from companies to payers of data from health economic studies that is not necessarily on the product's FDA labeling; here.  Said guidance was finalized in June 2018, here.   Dr. Gottlieb issued a blog.  For commentary by Peter Neumann and Harry Weissman in Health Affairs, July 2018, here.