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.
