Section 401.404 - Provider EligibilityAn independent clinical laboratory must be enrolled in Mass Health on the date of service in order to be eligible for payment.
(A)In-state Providers. To be eligible to enroll as a Mass Health provider, an independent clinical laboratory must be(1) located and doing business in the Commonwealth of Massachusetts;(2) certified as an independent clinical laboratory by the Centers for Medicare & Medicaid (CMS), based on the criteria set forth in the Clinical Laboratory Improvement Amendments (CLIA) of 1988; and(3) licensed as a clinical laboratory by the Massachusetts Department of Public Health.(B)Out-of-state Providers. A clinical laboratory that does not meet the requirements of 130 CMR 401.404(A) (1) and (3) may enroll in Mass Health only if the clinical laboratory is licensed as a clinical laboratory in its own state and meets the requirements of 130 CMR 401.404(A) (2), 401.405, and 450.109.(C)Multiple Facilities. When two or more independent clinical laboratories have the same director or owner, whether or not the laboratories have different names, each laboratory must enroll separately with the Mass Health agency and have its own Mass Health provider number.