IMPORTANT UPDATE: On November 16, 2023, Section 502 of the Further Continuing Appropriations and Other Extensions Act of 2024 was passed and delayed data reporting requirements for clinical diagnostic laboratory tests (CDLTs) that are not advanced diagnostic laboratory tests, and it also delayed the phase-in of payment reductions under the CLFS from private payor rate implementation. Please see below for the following changes:
- The next data reporting period will be from January 1, 2025 – March 31, 2025 and based on the original data collection period of January 1, 2019 through June 30, 2019.
- A 0% payment reduction will be applied for CY 2024 so that a CDLT that is not an ADLT may not be reduced compared to the payment amount for that test in CY 2023, and for CYs 2025-2027 payment may not be reduced by more than 15-percent per year compared to the payment amount established for a test the preceding year.
- After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2028, 2031, etc.).
The third step in the CLFS data collection process is report data. Reporting entities report applicable information to us. The next data reporting period will now be from January 1 – March 31, 2025.
- What’s a reporting entity?
The reporting entity reports tax-related information to the IRS using its TIN for applicable laboratories. The TIN-level entity and its applicable laboratories should establish their own approach for making sure the entity can report applicable information. They work together to determine the best approach to collect information from final paid claims data.
- What’s applicable information?
Applicable information includes:
- The specific HCPCS code associated with the test
- Each private payor rate for which final payment has been made during the data collection period
- The associated volume of tests performed corresponding to each private payor rate
- Do I need to report information?
Some laboratories must report information, including laboratory test HCPCS codes, associated payor rates, and volume data. Laboratories must report information if they:
- Are an applicable laboratory. See below for more information.
- Are one of these types of laboratories: independent, physician office, or hospital outreach (a hospital-based laboratory that furnishes laboratory tests to patients other than admitted inpatients or registered outpatients of the hospital)
- How do I know if I’m an applicable laboratory?
View Is My Lab An Applicable Lab? (6 min. video) to learn if your laboratory is an applicable laboratory.
An applicable laboratory:
- Bills Medicare Part B one of these ways:
- Under its own NPI.
- On the Form-1450 under type of bill (TOB) 14X, if a hospital outreach laboratory.
- Meets the “majority of Medicare revenues” threshold. This means when you add your revenue from Medicare CLFS and Medicare Physician Fee Schedule (PFS), it’s more than 50% of your total Medicare revenues.
Here’s how you determine if you meet the “majority of Medicare” revenues:
- Hospital outreach laboratories: Medicare CLFS revenues + Medicare PFS revenues received from the 14x TOB / Total Medicare revenues received from the 14x TOB
- All other laboratories: Medicare CLFS + Medicare PFS revenues received by your NPI / Total Medicare revenues received by your NPI.
To determine this:
- Add the Medicare CLFS revenues + the Medicare PFS revenues you got from your own NPI (or on the 14x TOB, if you’re a hospital outreach laboratory) during the data collection period (the numerator)
- Add the total Medicare revenues you got from your own NPI (or on the 14x TOB, if you’re a hospital outreach laboratory) during the data collection period (the denominator)
For purposes of determining whether a laboratory meets the majority of Medicare revenues threshold, total Medicare revenues includes the sum of all fee for service payments under Medicare Part A and B, Part D prescription drug payment, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period.
- Divide the Medicare CLFS revenues + Medicare PFS revenues you got from your own NPI (or on the 14x TOB if you’re a hospital outreach laboratory) during the data collection period (the numerator) by the total Medicare revenues you got from your own NPI during the data collection period (the denominator).
- Meets or exceeds the low expenditure threshold: This means that you get at least $12,500 of your Medicare revenues from the CLFS in a data collection period. To determine whether your laboratory meets the low expenditure threshold, total up all revenues received by your own NPI (or the 14x TOB if you’re a hospital outreach laboratory) for Medicare CLFS services during the data collection period.
Note for hospital outreach laboratories: If you bill Part B under the hospital’s NPI determine applicable laboratory status based on its Medicare revenues from the 14x TOB, you’ll most likely meet the majority of Medicare revenues threshold. You’ll most likely meet the majority of Medicare revenues threshold because your Medicare revenues are primarily, if not entirely, derived from the CLFS and or PFS. So, the revenues from the CLFS and or PFS services included in the numerator are essentially the same as the total Medicare revenues included in the denominator.
If your laboratory isn’t an applicable laboratory, don’t collect or report applicable information.
- Bills Medicare Part B one of these ways:
- When’s the next reporting period?
The next data reporting period for CDLTs is January 1 – March 31, 2025. We’ll update the CLFS with these amounts effective January 1, 2026.
- How do I report?
- What are final paid claims?
A final paid claim is the final amount paid by a private payor for a laboratory test during the data collection period.
If a private payor pays a laboratory for a test but subsequent post payment activities during the data collection period change that initial payment amount, the final payment is the private payor rate for purposes of determining applicable information. However, if we paid an initial claim in error during a data collection period and then the private payor corrects the initial claim with final payment made after the data collection period, the payment amount isn’t a private payor rate and you don’t report to us.
See examples of final paid claims (PDF) (PDF).