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Application for Level II HCPCS Code for ADLTs and FDA Cleared or Approved CDLTs

For tests granted ADLT status by CMS and for FDA cleared or approved CDLTs (that are not ADLTs), CMS will assign a unique level II HCPCS code to the test only if the test is not currently 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 applicant/notifying entity is not in the process of submitting an application to the AMA.

A “unique” HCPCS code is one that describes only a single test.

Level II HCPCS code assignments for ADLTs and FDA cleared or approved CDLTs (that are not ADLTs) will be conducted on a quarterly basis. CMS will review all applications for a unique level II HCPCS code to determine whether to establish a code after CMS has either granted ADLT status for the test or verified FDA clearance/approval, as applicable. The assigned HCPCS codes for ADLTs and FDA cleared or approved CDLTs will be given the letter “U” designation (i.e. Uxxxx). Newly established and revised level II HCPCS codes for these tests will be posted on CMS’ HCPCS website at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update.html under the U-Codes section.

Generally, there will be a “lag-time” of one calendar quarter between the assignment of a unique level II HCPCS code and the effective date of the new code. For instance, if CMS assigns a unique level II HCPCS code to an ADLT or FDA cleared or approved CDLT (that is not an ADLT) during the first calendar quarter of a given calendar year (January 1 through March 31), the unique level II HCPCS code will be effective and available for use on the first day of the third calendar quarter, that is, by July 1 of that year. The contact person for the applicant will be notified via email of the status of CMS’s review and decision to establish a unique level II HCPCS code for the laboratory test.

This table shows the schedule for assigning a unique level II HCPCS code for ADLTs and FDA cleared/approved tests for each calendar quarter scenario.

Level II HCPCS Coding Assignment and Effective Date Schedule

 Calendar Quarter

ADLT or FDA Cleared/Approved CDLT is Assigned Unique Level II HCPCS Code

Change Request Announcing Unique Level II HCPCS Code is Published

Effective Date of Unique Level II HCPCS Code

Q1. January 1 - March 31

4/1 - 4/30

7/1

Q2. April 1 - June 30

7/1 - 7/31

10/1

Q3. July 1 - September 30

10/1 - 10/31

1/1

Q4. October 1 - December 31

1/1 - 1/31

4/1

 The application for requesting a level II HCPCS code for ADLTs and FDA cleared or approved tests (that are not ADLTs) is accessible via the downloads section below.

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