Saturday, March 27, 2021

Mark Your Calendars: MedPAC PAMA Report on Lab Policies, Friday April 2

In December 2019, Congress delayed PAMA implementation by a year (and in Spring 2020, by an additional year).   However, in return, Congress required the federal advisory body MedPAC to report on PAMA policy and issues by April 2021.

That day has come.  

  • MedPAC has released its agenda for Thursday/Friday, April 1/2, 2021, and it includes a briefing on its Report to Congress regarding PAMA.   
  • Find the home page for the meeting here.  
    • MedPAC hasn't released the slides or text for the report yet.  
    • Transcripts are released a few days after the meeting.
    • At the website, look for a video registration links for GoToWebinar.  There's separate links for Thurs AM, Thurs PM, Fri AM.  They ask you to please, only sign up for sessions you will attend due to limited broadcast bandwidth.
    • There is a Public Comment box, but it's on the home page for Public Meetings, not on the home page for the April 1-2 meeting.  Here.  It just leads you to a comment mail box at .

PAMA TOPIC is scheduled from 11:00am to 12:30pm on April 2 (ET).  

MedPAC discussed lab pricing under PAMA in September 2020 (entry point here).  Their discussion of lab pricing falls in the context of increased molecular pathology spending, in round numbers from $500M in 2017 to $1B in 2018 to $1.5B in 2020.   Both OIG and MedPAC have pointed responsibilty to what they call "expensive tests."  OIG here.  In  is annual multi-topic report to Congress earlier in March, MedPAC suggested Congress or CMS restrict telemedicine orders of expensive DME or lab tests, due to  program vulnerabilities revealed by "Operation Double Helix."   Operation Double Helix asserted there had recently been $2B of genetic test fraud, much of it by fly by night telemedicine orders.  ("...fraudulent genetic cancer testing has resulted  in charges in five federal districts against 35 defendants associated with dozens of telemedicine companies and cancer genetic testing laboratories.")  For an example of a conviction of this type of telemarketing/telemedicine scheme after a 4-day trial, here.

The assertions about telemedicine misuse conflict with the complexity of genetic testing and the need for expertise (and, for commercial insurers, often preauthorization), which can often be provided by telemedicine by expert genetic counselors and physicians.   See for example the highly legitimate acquisition of Trapelo's precision oncology services and platform by NeoGenomics last week - here.  see also the alliance between Foundation Medicine and Informed DNA announced earlier this month - here.

I''ve argued in a series of 5 detailed reports that the Double Helix expenditures were almost entirely driven by a stupid lack of edits of very costly genetic test codes at just three MACs (Cahaba (now defunct), Novitas, FCSO).  Here.

The explosive growth in MoPath tests was only partly accounted for by reasonable growth (e.g. more tumor tests to guide drug choices).  Much of the growth was accounted for by genetics labs named in Operation Double Helix.  See for example the explosive growth in the code 81408, unedited-for in southern states.  But look equally at where 81408 was never paid!  Never billed by labs like Quest, Invitae, Ambry, Bioreference, etc.  And 81408 was essentially never paid in the MolDx 28 states (which have elaborate test controls, funding, and infrastructure) nor in the NGS MAC states (which have no novel controls or contracts for genetic testing.)

Practically100% of 81408 Spending, 2019, in Novitas & FCSO MACs


In December 2019 legislation, Congress delayed PAMA but required MedPAC to report on its implementation, options to streamline data collection.  However, Congress  added a phrase allowing MedPAC to also report on any issues it deemed relevant.

The PAMA delay is confusing.  Originally, national lab prices from 1H2019 would be submitted to CMS in 1H2020 to set prices in 2021, 2022, 2023.  Now, lab price data from 1H2019 will be submitted to CMS in 1H2022 to set prices in 2023, 2024, 2025.