Notification to CMS of an FDA Cleared or Approved Clinical Diagnostic Laboratory Test (CDLT) under the Medicare Clinical Laboratory Fee Schedule (CLFS)

On June 23, 2016, CMS published the CLFS final rule, “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (CMS-1621-F; 81 Fed. Reg. 41036 through 41101). The final rule implements section 1834A of the Social Security Act (the Act), which requires extensive revisions to the Medicare payment, coding, and coverage for CDLTs.

Section 1834A(e) of the Act also requires CMS to ensure that a unique HCPCS code is assigned for a laboratory test that is cleared or approved by the FDA. A “unique” HCPCS code is one that describes only a single test. To that end, the American Medical Association (AMA) will create level I HCPCS codes. CMS will create level II HCPCS codes to identify laboratory tests that are cleared or approved by the FDA, if the FDA cleared/approved test has not already been assigned a unique HCPCS code and an application has not been submitted for a unique level I HCPCS code to the American Medical Association (AMA) or the notifying entity is not in the process of submitting an application to the AMA.

To ensure compliance with these provisions, a laboratory or manufacturer, that is the notifying entity, must notify CMS of any FDA cleared or approved CDLT (that is not an ADLT) along with current coding information about the test.   Any laboratory which furnishes, designs, offers or sells a CDLT that has been cleared or approved by the FDA, or any manufacturer that designs an FDA cleared or approved CDLT, may submit a notification of FDA cleared or approved CDLT under the Medicare CLFS form to CMS. That is, the notifying entity must notify CMS about any CDLT that has been cleared or approved by the FDA — whether it has already been assigned a unique HCPCS code or has not yet been assigned a unique HCPCS code.

The notification to CMS of an FDA Cleared or Approved Clinical Diagnostic Laboratory Test (CDLT) under the Medicare Clinical Laboratory Fee Schedule (CLFS) is accessible via the downloads section below.