Laboratory Procedure Reporting
The Centers for Medicare & Medicaid Services (CMS) released, Sept. 25, a proposed rule that will significantly revise the Medicare payment system for clinical diagnostic laboratory tests (CDLTs) and advanced diagnostic laboratory tests (ADLTs) paid under the Clinical Laboratory Fee Schedule (CLFS) beginning in 2017. This proposed rule will affect laboratory procedure reporting. The new payment system will base payments on a median of private payer rates, as reported by certain laboratories during a specified period.
This proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.
Data Collection Requirements
Applicable laboratories will be required to report:
(1) The payment rate that was paid by each private payer for each test during the data collection period; and
(2) The volume of such tests for each such payer. The private payer rate will reflect the price for a test prior to application of any patient deductible and coinsurance amounts.
Labs Required to Report
CMS is proposing to define applicable laboratories at the Taxpayer Identification Number (TIN) level, rather than the National Provider Identifier (NPI) level.
The first round of data collection is scheduled for July 1 ? Dec. 1, 2015. Laboratories that received at least $25,000 of its Medicare revenues from the CLFS during this data collection period will be required to submit the data by March 31, 2016.
Thereafter, data reporting will fall on the shoulders of entities that receive in a data collection period at least $50,000 in Medicare revenues from lab services and more than 50 percent of their Medicare revenues from lab and physician services.
Coding and Documentation Provisions
Laboratories need to submit documentation to support their application for advanced diagnostic laboratory tests (ADLT) status and to create temporary G codes to identify new and existing advanced diagnostic laboratory tests (ADLT)s and Clinical diagnostic laboratory tests (CLDT)s that are FDA cleared or approved.
Action Items
Regardless of whether an organization will be required to report, this rule will affect payments for all tests paid under the Clinical Laboratory Fee Schedule (CLFS). You have until Nov. 24, 2015, to comment on this proposed rule. It would be appreciable if the physician laboratories and independent testing laboratories read the proposed rule carefully and be sure to read the final rule when it is released so as to understand the reporting requirements.