130 CMR 401.404
Provider Eligibility
An independent clinical laboratory must be enrolled in MassHealth on the date of service in
order to be eligible for payment.
(A) In-State Providers. To be eligible to enroll as a MassHealth 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
Services (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 MassHealth 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 MassHealth agency and have its own MassHealth provider number.