Novitas Solutions, Inc. (Novitas), the Medicare administrative contractor (MAC) for jurisdictions H and L (JH and JL) is in receipt of the new laboratory test codes identified by the Centers for Medicare & Medicaid Services (CMS) to be gapfill priced for 2025. As outlined in 42 CFR (Code of Federal Regulations) sections 414.507(g) and 414.508(a) and the Protecting Access to Medicare Act (PAMA) regulations, MACs will establish gapfill allowances using the following sources of information, if available:
1. Charges for the test and routine discounts to charges
2. Resources required to perform the test
3. Payment amounts determined by other payers
4. Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant
Novitas seeks your input on establishing pricing under the Medicare program for gapfill laboratory test codes 0020M, 0417U, 0420U, 0422U, 0425U, 0426U, 0436U, 0439U, 0440U, 0441U, 0443U, 0460U, 0461U, 0463U, 0466U, 0470U, 0472U, 0478U, 0483U, 0484U, 0485U, 0486U, 0489U, 0496U, 0498U, 0501U, 0508U, 0509U, 0510U, 82233, 82234, 83884, 84393, 84394, and 86581.
Novitas kindly requests that you complete our molecular diagnostic pathology survey and associated cost worksheet by February 28, 2025.
This survey is for information gathering for the Medicare clinical laboratory fee schedule gapfill pricing process. Though additional information on analytical and clinical validity and clinical utility of a molecular pathology procedure is appreciated, benefit category and coverage determinations are a separate process. It is important to point out that some of the services billed for genetic testing may not meet the Medicare reasonable and necessary threshold for coverage.
Please note that your answers will be kept to the greatest degree of confidentiality and will not be disclosed, except as may be necessary to share with others under confidentiality agreements with CMS for the sole purpose of establishing Medicare clinical laboratory fee schedule gapfill pricing.
Your responses will be reviewed and evaluated by Novitas and if proper, set forth in its recommendations to CMS of the appropriate fees for these tests. If no response is received, the fee will be determined by evaluating the charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
Note: The presence of an established local payment amount does not imply coverage.