CLFS Annual Public Meetings

Section 1833(h)(8) of the Social Security Act (the Act), as amended by Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) requires the Secretary to establish through regulations, procedures that permit public consultation for payment determinations for new Part-B covered clinical diagnostic laboratory tests (CDLTs). We publish a notice of upcoming meetings in the Federal Register. See the Clinical Laboratory Fee Schedule Annual Payment Determination Process (PDF) MLN educational tool for more information.

What occurs during the CLFS Annual Public Meeting?

The CLFS Annual Public Meeting allows the public to present comments and recommendations (including supporting data) on the appropriate basis for establishing payment amounts for new or substantially revised HCPCS codes being considered for Medicare payment under the CLFS for the next calendar year.

This meeting also provides a forum for the public to provide comments on certain reconsideration requests submitted during the previous year regarding final determinations on new and substantially revised test codes. For example, the public may provide comments on reconsideration requests regarding the basis of payment and the payment amount determined for new and or substantially revised test codes in which we used crosswalking as the basis of payment for the test. During the meeting, there’s an open forum where the audience and members of the CLFS Advisory Panel can ask questions.

What occurs after the CLFS Annual Public Meeting?

After the CLFS Annual Public Meeting, the CDLT Panel convenes (usually the following month) and provides recommendation for the basis of payment each new or reconsidered laboratory test. There are 2 methods to determine the basis of payment:

Crosswalking occurs when a new test or substantially revised test is determined to be similar to an existing test, multiple existing test codes, or a portion of an existing test code, so, the panel uses the existing test or codes to determine a payment
Gapfilling occurs when no comparable, existing test is available. In this case, the MACs develop a local payment amount for the new test code, and we calculate the median of rates for the test code across all MACs

Preliminary Determinations – September

Each September, we post preliminary payment determinations after considering the information from the annual laboratory meeting, public comments, and CDLT Advisory Panel recommendations.

The payment amount for a new gapfilled test isn’t established when we determine the basis for payment because it takes approximately 9 months from the CLFS Annual Public Meeting for MACs to establish MAC-specific amounts and report those amounts to CMS.

Final Determinations – November

Each November, we finalize the basis of payment for new and substantially revised test codes and the amount of payment through the annual CMS instruction implementing the updated CLFS for the next calendar year.

Reconsiderations

The public has an additional 60 days from the date we issue our annual instruction to request reconsideration of either the basis of payment (gapfill or crosswalk) or the amount of payment (if we used crosswalking as the basis of payment) for new and or substantially revised test codes. The public may comment on these reconsideration requests at the next CLFS Annual Public Meeting.

Gapfilling Schedule

For any new test code that will be gapfilled, we request our MACs develop MAC-specific gapfilled amounts for each test code and report the amount to us by April 1 of the following year.

Example:

July 2022 – Gapfilling recommended for new test code at the Annual CLFS Public Meeting
November 2022 – Recommendation finalized
April 1, 2023 – MACs report preliminary gapfilled amount for new test code

Public comments: Once the MACs develop gapfilled prices for tests and report to CMS, we post prices on our website and accept public comments on the gapfilled amounts for 60 days (not reconsideration requests, just comments).

Reconsideration requests: Once we post the final MAC-specific gapfilled amounts, we accept reconsideration requests on the final gapfilled payment amounts for new and substantially revised test codes for 30 days. However, once the reconsideration process ends for a gapfilling schedule, the gapfilled payment amount is final and not subject to further reconsideration.

We implement local MAC-specific gapfilled amounts based on the median of final gapfilled rates for the test code across all MACs.

Submit comments to clfs_inquiries@cms.hhs.gov.

Meeting Notice, Agenda, & Other Important Materials