As we discussed with our friends at Concert Genetics last week, bringing some semblance of order to the genetic testing industry won't be easy. The coding system for the tests, the demonstrated (or not) clinical utility and the sheer speed at which the industry moves has been no match for regulators. Yet, there is a growing awareness that Medicare and other payers are not sure what they are buying, why, and if it furthers their members' health goals.
In recent months we have seen a slow shift to encourage FDA approval to ensure some level of efficacy while the program integrity watchdogs start turning their wheels. Certainly, we are early in a process we have seen play out many times before in health care. That is why it is best to understand what the regulatory goals are, how they can be achieved and how long it will take for a shift from unfettered access to reimbursement to one that compliments related health care decisions.
Dr. Quinn, as usual, gave a cogent and often optimistic view of innovation generally and genetic testing in particular. You can link to replay below:
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Timestamps
0:00 - 5:05 How did we arrive in the wild west?
5:06 - 6:30 Giving the advantage to FDA approved tests? (Foundation, Epigenomics, ILMN)
6:30 - 9:51 Why didn't parallel review work? (EXAS)
9:51 - 11:03 Explosion of LCDs and MolDx
11:03 - 13:32 Evolution of MolDx program into categories/families
13.33 - 16:12 National Coverage Determination for NGS and push to FDA (GH, Foundation, Caris)
16:12 - 18:06 Liquid biopsy National Coverage Determination (Epigenomics, EXAS)
18:06 - 21:26 Breakthrough technology designation and does it matter?
21:27 - 26:59 The future of LCDs and MACs
26:59 - 32:05 HHS decision on FDAs purview of LDTs
32:05 - 33:31 How competitive landscape for tests might change
33:31 - 39:52 Fraud, waste & abuse in genetic testing in Medicare and expansion of legitimate testing
39:52 - 40:34 Return of the budget hawks and fighting fraud, waste and abuse.
40:34 - 48:13 New Office at Center for Medicare - Technology, Coding and Pricing Group
48:14 - 58:50 Q & A (Sensitivity and specificity in liquid biopsy)
If you have not already, be sure and visit Dr. Quinn's blog at www.discoveriesinhealthpolicy.com where you will find insight and some humor on a regular basis.
About Bruce Quinn: Bruce Quinn MD PhD is a leading expert on federal health policy and how innovative technology companies can adapt for success. His consulting practice, with offices in Los Angeles and San Francisco, works with leading genomic, medical technology, and biopharma companies. Originally trained as a neuropathologist, earlier in his career he held tenure-track faculty positions at NYU Medical School and the Northwestern University School of Medicine.
As a physician executive, he has held positions with Accenture’s healthcare strategies practice, the Medicare program, and with health policy groups in two law and lobbying firms. Recent publications have included articles on defining clinical utility for diagnostic tests and a review of the emerging digital genomics industry. In addition, his blog, DiscoveriesInHealthPolicy.com, covers innovative health care policy developments and receives over 100,000 hits per year.
