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CMS Issues Guidance on Clinical Laboratory Fee Schedule Reporting Requirements

Significant guidance specific to hospital-outreach laboratories

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The Centers for Medicare & Medicaid Services (CMS) has issued additional guidance for laboratories that are required to report private payer data for laboratory tests under the clinical laboratory fee schedule (CLFS). CHA urges any hospital with a laboratory that bills Medicare on a Form CMS-1450 14x Type of Bill to carefully review the guidance to determine its status as an applicable laboratory.

Under the Protecting Medicare Access Act of 2014, CMS must use private payer data reported from certain laboratories to set the CLFS payment rates every three years. CMS recently finalized changes to the definition of “applicable laboratory,” expanding the number of hospital-based laboratories that will be required to report data collected during the period of Jan. 1 – June 30.

CMS published the following documents to assist laboratories in understanding the reporting requirements:

  • Summary of Private Payor Rate-Based CLFS: This document provides an overview of key terms and concepts used under the private payer rate-based CLFS. It also includes general information on how to determine whether a laboratory is considered an applicable laboratory under the regulations, as well as collecting applicable information and reporting applicable information.
  • MLN Matters Revised Information for Laboratories on Data Collection and Reporting: This document provides detailed information and examples related to determining applicable laboratory status, applicable information, the schedule for the next data collection and reporting cycle, reporting entities and data reporting, and the schedule for implementing the next private payer rate-based CLFS update. A number of examples are specific to hospital-outreach laboratories.
  • Frequently Asked Questions: The new FAQ document focuses on changes made to the definition of applicable laboratory in the calendar year 2019 physician fee schedule final rule.