CMS Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting
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 clinical diagnostic laboratory tests under Medicare Part B. Section 1834A(f) of the Act requires consultation with an expert outside advisory panel on such payment determinations. These procedures are set forth in 42 C.F.R. § 414.506.
What occurs during the CLFS Annual Public Meeting?
The CLFS Annual Public Meeting provides an opportunity for the public to present comments and recommendations (including accompanying data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the CLFS for the next calendar year (CY).
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 (crosswalk or gapfill) and the amount of payment determined for those new and or substantially revised test codes in which crosswalking was used as the basis of payment for the test.
What occurs after the CLFS Annual Public Meeting?
Following the CLFS Annual Public Meeting, CMS continues to accept public comments for approximately 1 week and then determines whether the crosswalk or gapfill methodology should be used as 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, which can then be utilized 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 CMS calculates an NLA after a year of payment at the local MAC rates based on the median of rates for the test code across all MACs.
After we determine a basis of payment, we post preliminary determinations on our website in September of each year. We accept additional public comments on preliminary basis of payment determinations through October of each year.
Unlike a new crosswalked test, the payment amount for a new gapfilled test is not 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.
In November of each year, CMS finalizes 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 CY.
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 crosswalking is used 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.
For any new test code that will be gapfilled, we request our MACs to develop MAC-specific gapfilled amounts for each test code and report the amount to CMS by April 1 of the following year. Example: At the July 2016 Annual CLFS Public Meeting, gapfilling is recommended as the basis of payment for a given new test code and that recommendation is finalized November 2016. In this case, the MACs have until April 1, 2017 to develop and report a preliminary gapfilled payment amount for the new test code.
Once gapfilled prices for tests are developed by the MACs and reported to CMS, we post prices on our website and accept public comments on the gapfilled amounts for 60 days (not reconsideration requests, just comments). After review of the MAC-specific gapfilled amounts and public comments received, we post final gapfilled amounts to our website by September 30 of that year. Example: MACs submit gapfilled amounts to CMS by April 1, 2017; we post the MACs’ gapfilled amounts on our website by June 1, 2017, and accept public comments on those preliminary gapfilled amounts until early August 2017. We post the final MAC-specific gapfilled amounts on our website in September 2017.
Once we post the final MAC-specific gapfilled amounts to our website, 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 cycle, the gapfilled payment amount is final and not subject to further reconsideration.
CMS implements an NLA after a year of payment at the local MAC-specific gapfilled amounts based on the median of final gapfilled rates for the test code across all MACs. For example, MAC-specific gapfilled amounts finalized in November 2017 would be used to establish an NLA for the test and the NLA would be effective for the CY 2018 CLFS.
**The 2018 Final Gapfill file is posted below (2018 CLFS Gapfill Final Determinations). CMS is accepting comments until November 19, 2018. Comments must be submitted electronically by this date to the following CMS mailbox: CLFS_Annual_Public_Meeting@cms.hhs.gov. Contractors have provided rationale on their recommendations to CMS which can be found in the last column of each row.
Meeting Notice and Agenda
We publish a notice of upcoming meetings in the Federal Register and post the meeting agenda on this webpage.
- Power Point Presentation Template [PDF, 71KB]
- Past Laboratory Public Meeting Agendas and Federal Register Notices
- Register for the CLFS Annual Laboratory Public Meeting
Test Codes and Payment Determinations
- CY 2019 – Clinical Laboratory Fee Schedule Test Codes Final Determinations [PDF, 217KB]
- CY 2019 – Clinical Laboratory Fee Schedule Test Codes Preliminary Determinations [PDF, 233KB]
- 2018 CLFS Gapfill Final determinations [ZIP, 19KB]
- 2018 CLFS Gapfill Preliminary Determinations - Updated 06/13/2018 [ZIP, 17KB]
- Previous Years Test Codes and Payment Determinations [ZIP, 2MB]
Note: Visitor Access to Federal Buildings
The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver’s licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver’s license or ID card from a state unless the Department of Homeland Security determines that the state is in compliance with the Real ID Act.
Beginning in October of 2015, photo IDs (such as a driver’s license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter Federal buildings. As of January 26, 2016, the following states/territories are not compliant with the Real ID Act: American Samoa, Illinois, Missouri, Minnesota, New Mexico, and Washington. This means CMS visitors from these states/territories will have to be escorted at all times while in CMS buildings. CMS visitors from these states/territories need to provide alternative proof of identification (such as a passport) to gain entrance into Baltimore-based and Bethesda CMS buildings, as well as the Humphrey Building in Washington, DC. For CMS regional office locations the Real ID Act requirements are implemented by Federal Protective Services.
- Page last Modified: 02/28/2019 7:41 AM
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