Kim Tyrrell-Knott Quoted in “FDA, CMS Indefinitely Extend Parallel Review; Industry Response Muted”Inside Health Policy October 21, 2016
Kim Tyrrell-Knott, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s San Diego and Washington, DC, offices, was quoted in Inside Health Policy, in “FDA, CMS Indefinitely Extend Parallel Review; Industry Response Muted,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
The issue of NCDs is still a concern for industry, particularly for small companies, according to Kim Tyrrell-Knott, an attorney at Epstein, Becker & Green.
"If you're a smaller company and this is your only product and you go through the National Coverage Determination route, you're betting the farm," said Tyrrell-Knott.
Tyrrell-Knott praised the program, but maintained that guidance around coverage and extending the program to a wider subset of devices could ensure the program has a greater impact. Additionally, she applauded a move made by FDA in February to provide a mechanism for sponsors to contact payers to provide input in FDA pre-submission meetings.