In the near future, CMS is (1) posting information on the July CLFS pricing meeting, (2) posting the "Spring" full list of proposed 2016 gapfill prices from its MACs, and (3) releasing final rulemaking for PAMA Section 216.
One down, two to go.
The July 2016 CLFS meeting is going to be on Monday, July 18, 2016. The CMS agenda is online here. Stated separately in a Federal Register meeting announcement (here) the morning will be crosswalk/gapfill discussions and the afternoon will be a session of the PAMA CMS laboratory advisory board.
(For the advisory board session, look for an eventual agenda here.)
The CMS proprietary three level G-code system for drugs of abuse screening are being transferred to newly minted AMA CPT codes in the 80000 series. There is a Category I code for Septin9 methylation analysis, reflecting the Epi pro Colon test approved by the FDA in April 2016 for blood-based colon cancer screening. The OPKO 4KScore test for prostate cancer risk is a new Category I MAAA code.
There are new genomic sequencing procedure codes for cardiac ion channelopathies (at least 10 genes), inherited cardiomyopathies (at least 5 genes), and fetal microdeletions such as diGeorge syndrome, in circulating cell free DNA. There is also a panel code for infectious agent pathogens by DNA/RNA, 12-25 targets.
Reconsideration of Pricing
Finally, there is a reconsideration request for the recently priced CMS G codes for drugs of abuse screening (G0481, G0482, G0483). For policy nerds, this means the current prices of G0481-2-3 will be under a legal pricing challenge at the same point in time that CMS is crosswalking the prices to the new equivalent 80000 series CPT codes.
Registration will be via a CMS website, but does not open until Monday, June 6 (see Federal Register notice). The deadline for submission of electronic presentations is July 1, and presentations are emailed directly to CMS staff (see Federal Register notice). After the July 18 meeting, CMS will take comments for 15 business days, until August 8. CMS will submit pricing preliminary decisions in "early September" and take comments on them until "early October." Final pricing decisions appear around November 1.
Policy Calendar Tidbit
The next day, Tuesday,July 19, FDA holds a workshop on liquid biopsy genomics in cancer (here).