Sunday, February 14, 2016

Communicating with Payers versus Communicating with the FDA

At the beginning of the year, the FDA released an elaborate new 30-page guidance document for industry, "Best Practices for Communication between IND Sponsors and the FDA during Drug Development" (here).  For open access trade press and blogs, see RAPS here, Weinberg Group here, 505(b) Blog here, and PPDI here.  Comparison to "payers," after the break.

This document is worth reading in that it shows ways that communications between FDA and industry is far ahead of communications between payers and industry.  Many CMS local contractors (MACs) are nearly impossible to communicate with, though this is not always true.  The Palmetto MolDX program, a special local Medicare program providing pricing and coverage in about twenty states for genomic tests, holds regular teleconferences or even live meetings with product sponsors and has a formal process for doing so.   Regarding things Medicare, it's actually easier to get meaningful meetings with CMS central office staff in Baltimore than for many local MAC issues.

Meeting with the diversity of commercial payers (and Medicaid programs) nationwide is a highly variable and hit and miss process with unpredictable rules and twists and turns.

One effort to improve communication between payers and industry are the Evidence Guidance Documents produced by the Center for Medical Technology Policy (CMTP) in Baltimore on a rolling basis through multi party stakeholder collaboration (here).  Ten have been produced from 2009-2015.

For a February 2016 FDA invitation for payers to join device review meetings, see here.