Thursday, August 24, 2017


Many stakeholders across the precision medicine industry - from hospitals to independent laboratories to patient and clinician groups - find that Medicare's ten year old "14 day rule" makes little sense.

Under the rule, all genomic tests on blood or tissue biopsies from hospital outpatient settings can be billed only by the hospital, even if ordered (especially on tissue) by doctors unrelated to the hospital and processed by labs thousands of miles away.   Especially rural hospitals have no experience with what amounts to "buying and billing" complex specialty genomic tests.

Modifying the 14 Day Rule - A Real Possibility for the First Time
In proposed rulemaking on July 20, 2017 for hospital outpatient services, CMS proposed that it might drop the hospital billing requirement for post discharge outpatients.   Stakeholders should applaud this move and have the opportunity to comment until September 11, 2017.   Your remarks will be counted.  

  • See the full federal rulemaking online here (the 14 day rule section is page 33650ff ).   
    • The painfully awkwardly written full rule is here at 42 CFR 414.510.   
      • (To avoid hurting your retinas, I recommend getting out your solar eclipse goggles.)
  • Your comments must be submitted through a federal comment portal, here; see box "Submit a formal comment."    

Also: Comment on PAMA Lab Data Collection User Experience
Separately, in a different document for Physician rulemaking, CMS requested comments on its data collection operations and the community's user experience for PAMA market pricing of lab tests.

See that rule here and section on "comments on data collection" for PAMA, page 34089ff.  The physician rule comment webpage is here and this is different from the webpage for commenting on the Outpatient rule and the 14 day rule.

Finally: Keep One Eye on Radiology "Appropriate Use" Laws and Regulations
Finally, for anyone who tracks the growth of Laboratory Benefit Managers in the lab industry, they should at least be aware of CMS's efforts to implement mandatory Appropriate Use Criteria in imaging (physician rule, page 34091ff).   It's easy to imaging Congress asking CMS to apply ordering rules like Appropriate Use Criteria to genomics as well in some future year.

For CMS nerds, the dense multiple data tables supporting the Physician 2018 Rule are at CMS, here.  Background files for the Outpatient rule are here.