Thursday, April 9, 2020

MolDx Requires New Appproach to Gapfill Pricing; Posts Rules

This year, about half of 90 PLA codes were sent to the MAC Gapfill process for pricing.  During the first months of the year (ideally Jan-Feb, in practice Jan-April) each MAC prices each code that is sent to the gapfill process. 

The rules are in bare-bones text and are found in a federal regulation at 42 CFR 414.508:   Consider the charges for the test, the resources required, the payments of other payers, and charges/payments/resources for similar tests - then the MAC sets a price. 

The prices are collated by CMS, which sets the test price at the median of the MAC prices (after a comment period).   The prices stay the same until the next three-year PAMA data cycle.

MolDx now provides more guidance and more detail. 

See the "MolDx Pricing Worksheet" as a splash screen on their home page:

I've put a screen shot below, click to enlarge.  I've put an archival cloud copy here.

Answer these questions:

5-year expectations for:
 - Test volume
 - Test capacity
 - Cost of Goods
 - Labor
 - Indirect costs
 - Total capital equipment cost
 - R&D cost

For R&D, "if already in production, put all current R&D in Year 1."

Then list the list price of test, and any discounts.

The list any tests that are similar for comparison (e.g. crosswalk is a good match).

Finally, list any prices from other MACs and state whether the test is FDA approved.

That's it.