Wednesday, October 2, 2019

Very Brief Blog: 21 Comment Files on CMS Molecular "Date of Service" Changes


CMS proposed changes to its molecular test date of service rule.  At least 21 entities submitted comments.  (Note, there could be more that my key word search didn't pick up.)


The Medicare Date of Service rule for lab tests dates to about 2008, and requires lab tests to be billed by a hospital outpatient center if ordered within 14 days of the date of discharge (e.g. the biopsy date for an outpatient surgery, or the blood draw date for a hospital outpatient clinic patient).   This is also the date after an inpatient discharge when a lab test becomes payable, not bundled to the DRG.

Around 2014, Medicare began bundling all lab tests associated with an outpatient hospital visit unless they are human molecular tests (microbiology molecular tests are bundled).

Around 2018, CMS proposed that molecular lab tests billed within the 14 day window should be billed by the lab that runs the test - in some cases the hospital itself, in other cases a remote reference lab.   In 2018 and 2019, CMS has allowed either the hospital or the remote reference lab to bill for a reference lab test.  Compliance can be complex (here).


In Summer 2019 rulemaking, CMS proposed several changes that agitated the lab community, including a proposal to bundle all molecular tests (unless they were ADLT tests), or alternatively, to require the hospital-only to bill within 14 days (the status quo 2008-2017).   The rule also involved blood bank labs.

For more background on the above issue, see blog here.  The OPPS rule itself (84 FR 39598ff) contains a very thorough history of the topic.


OK.  The comments are in; I was able to pull 21 of them (by searching here) and have put the resulting 30 mb ZIP file in the cloud: here.

Commenters include:
  • AABB
  • Abbott
  • Abbvie
  • ASCO
  • ASCP
  • Biodesix
  • Biotheranostics
  • Century 21 Coalition
  • CAP
  • CareDx
  • CDx
  • Cleveland Clinic
  • Exact Sciences
  • Guardant Health
  • LUNGevity
  • NCCN
  • PEACH [hospital coalition]
  • Pfizer
  • PFS [Lab] Coalition
  • Red Cross
  • Veracyte

There could be comments that weren't released yet to the web by CMS or that I missed with my keywords.

I used keywords "date of service" & "molecular" so I think this inventory of PDF's is pretty comprehensive, but it might not be a perfect list.