Upcoming Hospital Clinical Laboratory Reporting Requirements: What You Need to Know

AHA Regulatory Advisory
November 30, 2021

Download the Regulatory Advisory

At A Glance

Please note, on Dec. 11, President Biden signed legislation that delays by one year (until Jan. 1, 2023) the clinical laboratory reporting requirements discussed in this advisory. It also delays for one year payment cuts under the CLFS that would have otherwise been imposed starting Jan. 1, 2022. The AHA and others have advocated for these requirements to be delayed. For more information on this legislation, please see the Special Bulletin  sent to members on Dec. 9.

In the Centers for Medicare & Medicaid Services’ (CMS) 2019 physician fee schedule (PFS) final rule, the agency made an important change to the Clinical Laboratory Fee Schedule (CLFS) that will require certain hospitals to report private payer rates and volumes for clinical laboratory services covered under the CLFS. One such reporting period for hospitals is coming up in the first quarter of 2022.

Specifically, hospitals will be required to collect and report certain private payer data if they bill Medicare for laboratory services on the CMS 1450 14X Type of Bill (TOB)1 and received at least $12,500 in Medicare revenues from CLFS services on this bill type during the “data collection period” of Jan. 1, 2019 through June 30, 2019. These hospitals will be required to report data on private payer prices and the volume of laboratory services paid at each price during the “data reporting period” of Jan. 1, 2022 through March 31, 2022.

CMS has posted several updated documents and other resources to help hospitals determine if they need to report, and if so, how to report. The resources include:

  • Summary – An overview of key terms and concepts and how to determine whether your laboratory is an applicable laboratory.
  • CLFS Data Collection System User Guide – Updated guidance on registering as a CLFS submitter and CLFS certifier and reporting and certifying applicable information will be posted soon.
  • MedLearn Matters Article – Medicare Part B CLFS: Revised Information for Laboratories on Collecting & Reporting Data for the Private Payor Rate Based Payment System.
  • Frequently Asked Questions
  • Webinar slides and a video recording of CMS’ Nov. 10 webinar “CLFS Private Payor Data Collection and Reporting.” The webinar password is W&KZ@=7?

What You Can Do:

  • Share this advisory with your chief financial officer, director of clinical laboratory services and other members of your senior management team.
  • Determine whether you have an “applicable laboratory” that needs to report “applicable data” during the upcoming data reporting period. Consult CMS’ resources for guidance.

Further Questions:

For additional questions, please contact Roslyne Schulman, AHA director of policy, at rschulman@aha.org.

View the detailed advisory below.

Related Resources

Letter/Comment
Public
AHA provides feedback on the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S.4348).
Letter/Comment
Public
The AHA and FAH urge CMS to deny DHR’s request for an exception to the prohibition on expansion of the facility capacity of a physician-owned hospital. CMS is…
AHA Center for Health Innovation Market Scan
The Hippocratic oath has provided an ethical guide for physicians for centuries. Updating language about patient privacy to include data privacy and…
Fact Sheets
Public
At the outset of the COVID-19 pandemic, the Centers for Medicare…
Special Bulletin
Public
The Office of the National Coordinator for Health Information Technology (ONC) Jan. 21 issued a request for information (RFI) regarding prior authorization…
Special Bulletin
Public
The Centers for Medicare & Medicaid Services (CMS) yesterday released proposed regulations for the 2023 Medicare Advantage (MA) and Part D plan year.