Somewhat belatedly, on March 23, 2018, CMS released application forms, quarterly calendars, and additional guidance for becoming a MAAA. Find the CMS webpage HERE.
CMS provides a 17 page application form and a 30 page guidance document. Half the guidance document is about price reporting (applicable periods, TINs, special cases, etc.)
CMS is planning to enforce a rule (not found in the PAMA law) that the test must provide "new clinical diagnostic information not available from any other test or combination of tests." The applicant writes this justification itself, and it's not obvious how CMS staff would search the market for tests not named by the applicant (this might take a lot of content knowledge about the industry, available tests, and clinical care pathways), but they will use the Advisory Panel on Clinical Diagnostic Laboratory Tests to assist them (guidance document, page 8). They don't mention an appeal process yet.
- The "originality clause." I never thought this whole "originality clause business" was applicable, since it's not in statute, and even more, the statute explicitly contemplates ADLTs that are 510(k) tests, thus, have a close predicate and often the same intended use.
- It's unclear exactly how CMS will apply these originality concepts (e.g. for competing breast or prostate cancer MAAAs) or if a test would cease to be an ADLT in the future if a too-close competitor appeared.
- CMS seems to box itself off unnecessarily from value-based purchasing.
- For example, if a test replicates a prior ADLT MAAA, but is performed twice as fast at half the cost, it might not be able to be an ADLT because it didn't have a "unique" clinical purpose.
- Would the FMI F1 test be "original" enough? Both the FDA approval and the CMS coverage focuses laserlike on its CDx tests, but exactly those F1 CDx tests are generally available from "one or more other tests on the market."
- OK, this is a trick question, because this is a PMA/510k category ADLT ("criterion B ADLT").
- Some tests may be both a Criterion A ADLT (it's a unique MAAA) and a Criterion B ADLT (it's a sole source MAAA that is FDA approved). It may be better to apply for ADLT for this test as a "Type B ADLT" because it avoids any review under the originality clause.
- If you upgrade your test (from a 50 gene to a 51 gene MAAA) to your reboot the ADLT periods by becoming a "new" MAAA ADLT?
- If you're an LDT, how do you define and revise your "claim?" Isn't partly it up to you? The FDA and CLIA aren't writing your "Claim" for you like the FDA does for reviewed products with formal FDA labeling.
- The "Licensing clause?" What Licensing clause?
- In final PAMA rulemaking, June 23, 2016, CMS said that a university that licensed-out IP for a test could not be the test developer, but also, that a lab that licensed-in IP for the test could not have been the sole developer, either, and neither could be an allowable "successor laboratory." Since almost all tests license some IP from somewhere, this seemed tortuous.
- See and read: 81 FR 41060, column 1, June 23, 2016.
- Gratefully, CMS has chosen to simple drop any explicit reference to this perplexing part of the original rulemaking.
- However the paperwork does refer to "the lab that DESIGNS" the test in a few places, not just the lab that solely provides the test.
Tests must show they have been "covered by Medicare Part B." This is probably a good thing, because it means early policy benefits won't expire while the newly launched test is just awaiting coverage.
CMS webpage here.
Once tests have coverage, they can apply for ADLT. ADLT law gives them "market list price" payment for 9 months, then payment at an annually surveyed market median price. (This latter survey median price is similar to the triennial survey price for regular lab tests).
Often lab tests (like other health services) have list prices that float substantially above actual prices, e.g. $4000 list, but real world discounted $2200 average price from payers.
If the gap between the initial "list" payments and the later "average" payment is large (130%), CMS can recoup the difference. It's not hard for CMS to do this, it's common; MAC just sets up a debit against future payments. Labs would be incented (in their first nine months) to accept high payments but appeal low payments to ensure only high payments are logged for CMS price setting review. This pushes the lower priced claims like a bolus into the next fiscal period, but the first fiscal period is weighted most heavily due to the clawback rule. Want to see in real numbers? I show an example where a lab gets $21M instead of $13M (net of clawbacks) in years 1 and 2 together, here.
See also Medlearn Article SE1619, 2017, which provides general guidance on CLFS PAMA reporting.