[UPDATE: SEE THE UPDATED DECEMBER 16 BLOG
WRITTEN AFTER THE CLOSE OF THE COMMENT PERIOD: HERE.]
November 12, 2015:
Medicare issued proposed regulations for implementing PAMA's changes to the Clinical Laboratory Fee Schedule on September 23 (Federal Register final version, October 1, here). The comment period runs til November 24, and comments can be typed up and entered online here.
As of November 12, 75 comments had been submitted. About 15 are similar letters from employees of Quest Diagnostics. Otherwise, most of the comments represent a lengthy form letter submitted from dozens of individuals.
My comment, focused only on the definition of ADLT, is here.
An example of the Quest letter is online here. The other letter, submitted in over 50 copies, is here.
The shortest of all comments so far is here: "OPPOSED!"
The Quest letter raises concerns that small physician, small labs, and hospital labs would be admitted from the census of test payments, as proposed by CMS. CLIA ID rather than Tax ID should be used as the unit of counting. The data collection period comes too fast, without adequate notice and rulemaking. The data collecting period of at least 6 months should occur after final rulemaking, and a three month window should intervene before a 3 month reporting period.
The more populous form letter also states that labs are defined too narrowly, omitting hospital labs and physician labs. It notes that Congress anticipated an 18 month implementation period between final rulemaking and the date when the new fee schedule would be put into use. Please implement PAMA on January 1, 2018. Different submissions of this form letter include, or omit, a closing paragraph that ADLTs should include protein only tests.
A letter from attorney Jane Pine Wood also protests the exclusion of hospital labs from reporting.