On Monday, I was on a panel for Personalized Medicine Coalition discussing external constraints on Medicare. I discussed four. (1) CMS doesn't set prices (doesn't encourage or discourage by pricing), but prices are set by PAMA (at least PAMA takes over after an initial period). (2) CMS almost never makes lab codes, but follows what the AMA produces. For better or worse, CMS initially prices all lab codes coming out of the AMA CPT process, whether CMS uses the codes or understands the particular service. (3) In the case of a recent NCD for NGS testing, CMS handcuffs its coverage to FDA decisions. (4) In the case of preventive services, CMS is tied either to those provided by Congress or those endorsed by USPSTF. USPSTF has a very slow time cycle (up to 5-10 years) and almost never reviews de novo services. This is an artificial barrier to investment in preventive services technologies.
On Thursday, I give a talk on recent NCDs and LCDs. For the NCD, I focus on the CMS NCD for NGS tests in cancer patients, and for LCDs, I briefly profile five very recent MolDx LCDs. I showed that just three companies (FMI, Exact, Guardant) had variance of about $20B in upward marked cap tied in part to NCD/LCD decisions.
I also have a slide showing 2018 review times once an LCD has undergone public comment - how long til the final LCD is released. (76-250 days).
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- (1) Short deck on Constraints on Medicare here.
- (2) Deck on Recent NCDs and LCDs here.
- (3) Zip file holding six or seven recent proposed "MolDx" LCDs here.