Smart play Pez,
Some excellent research once again from Owl, thankyou.
I was reading up about the process for reimbursement codes and coverage in the United States, it’s certainly a complex process.
Euroz Detailed out the steps in their broker report, I've copied and pasted it here for reference.
If Breakthrough designation is granted and we get a free ride on the Medicare reimbursement via CMS, we are in for a rapid deployment of PromarkerD! This really would be a significant milestone following a distribution partner agreement. I'm super excited Owl! as we talked earlier, given Richard announced FDA pre-submission meeting in Feb and the Medicare coverage for Breakthrough designation being announced in January, the timing seems very closely orchestrated
While we all know KidneyIntelX (RENX) is targeting later stages of CKD it received its Breakthrough designation by the FDA back in 2019 , I can’t see why PromarkerD wouldn’t also be classified as a breakthrough designation, being a similar ‘predictive test’.
Again from Euroz report – RENX rallied very hard through its process.
No doubt the next 12-24months is going to be very exciting for PIQ, lots of price catalysts as many of our active studies will move from discovery into clinical studies & revenue should start flowing in from PromarkerD. Hold onto your hats, $1 (fingers crossed) should be left in the dust as things materialize.
Reimbursement Codes & Coverage (From EUROZ Report)
In the United States, the process involves first applying for a relevant reimbursement code. In the case of PromarkerD, this would fall under the CPT® Proprietary Laboratory Analyses (PLA) code set. CPT PLA codes are managed by the American Medical Association (AMA) through the CPT Editorial Panel. Codes can be applied for and granted quarterly (fall, winter, spring,summer)
The process takes a ~3 months from application deadline to code publication date, consider the “Fall 2020” quarter timeline as an example:
Oct. 7 – Application submission deadline
Oct. 14 – Public agenda posted to website
Oct. 23 – Interest party comment request deadline
Oct. 28 – PLA-TAG consideration completed
Nov. 5 – Panel vote (at panel meeting)
Jan. 1 – New and deleted codes, publication date
Apr. 1 – New and deleted codes, effective date
Codes then become effective the following quarter, whereby test can be sold and reimbursed using the code. Although securing the physical code itself is broadly straight forward, the greater challenge and more complex component is making sure that connected code will be covered by insurers. This means engaging with these key stakeholders and outlining an acceptable price point for PromarkerD, as PIQ has articulated it has done and is continuing to do (i.e. $50-150/test price points).
This next step towards establishing broad adoption of the code involves engaging with the Centres for Medicare & Medicaid Services (CMS) to establish of a national Medicare price in the Clinical Laboratory Fee Schedule (CFLS).
Following this, the CMS determines whether and to what extent a new product will be covered and reimbursed under Medicare, this decision is typically followed closely by private payors.
This final process is one of the most important, it involves seeking a National Coverage Determination (NCD). This can be requested by either external parties (e.g. PIQ) or by CMS under different circumstances.
The process takes 6-9 months from application to final decision. In the absence of a NCD, coverage is at the discretion of Medicare contracted based on a local determination.
(20min delay)