130 CMR, § 455.417

Current through Register 1538, January 3, 2025
Section 455.417 - Laboratory Services

A UCC may claim payment for the laboratory services listed in Subchapter 6 of the Urgent Care Clinic Manual only when all of the following conditions are met.

(A) The laboratory services are performed in the UCC.
(B) The laboratory tests are performed on properly and regularly calibrated equipment, and daily controls are carried out.
(C) The UCC has been certified by the Centers for Medicare & Medicaid Services (CMS) for performing in-house clinical laboratory services, based on the criteria set forth in the Clinical Laboratory Improvement Amendments (CLIA) of 1988, as it may be amended. In addition, the UCC's laboratory must maintain its own quality control program and successfully participate in one or more proficiency testing programs that cover all Medicare-certified specialties and subspecialties of the laboratory. The UCC must make the results of the proficiency testing programs available to the MassHealth agency and the Attorney General's Medicaid Fraud Division upon request or during an on-site visit.
(D) If the UCC is located in-state, the UCC has been approved by the Massachusetts Department of Public Health to perform in-house clinical laboratory services. If the UCC is located out-of-state, in addition to meeting the requirements of 130 CMR 455.404(B), 455.417(A) through (C), and 130 CMR 450.109: Out-of-state Services, the UCC must also meet its own state's requirements for performing in-house clinical laboratory services.

130 CMR, § 455.417

Adopted by Mass Register Issue 1461, eff. 1/21/2022.