130 CMR 449.404
Participating Correctional Facility Eligibility
(A) A correctional facility is eligible to enroll as a participating correctional facility only if the
correctional facility meets all provider participation requirements in 130 CMR 449.000 and
450.000: Administrative and Billing Regulations.
(B) Clinical Laboratory Services by Participating Correctional Facility. A facility or partnering
contractor that provides services listed in 449.412(C) that operates a clinical laboratory, must be
certified as a clinical laboratory by the Centers for Medicare & Medicaid Services, based on the
criteria set forth in 130 CMR 401.404(A)(2). 42 CFR Part 493: Laboratory Requirements sets
forth the conditions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A
facility that conducts CLIA-waived testing only must obtain a CLIA Certificate of Waiver by
meeting the exemption conditions under 42 CFR Part 493 Subpart B: Certificate of Waiver and
submitting an application for a Certificate of Waiver. A facility that conducts laboratory testing
that is not CLIA waived must be in compliance with the Certificate of Waiver, Certificate of
Compliance, Certificate for PPM procedures, or Certificate of Accreditation applicable to the
category of examinations or procedures performed by the laboratory.
(C) Radiology Services by Participating Correctional Facility. A facility or partnering contractor
that provides services listed in 449.412(C), that provides radiologic services, must meet the
conditions under 42 CFR 482.26: Condition of participation: Radiologic services and under 42
CFR 483.50: Laboratory, radiology, and other diagnostic services.
(D) Substance Use Disorder Treatment Program Operated by Participating Correctional Facility.
A facility that operates a substance use disorder treatment program that provides reentry
demonstration services must receive approval from the Department of Public Health, pursuant to
105 CMR 164.600 through 164.626.
(E) Pharmacy Services by Participating Correctional Facility. A facility that provides reentry
demonstration pharmacy services must ensure that all pharmacists providing services are
(1) licensed in good standing with the Massachusetts Board of Registration in Pharmacy,
consistent with 247 CMR 2.00 and 247 CMR 3.00; and
(2) licensed by the federal Drug Enforcement Administration (DEA) and possess a DEA
registration number (if applicable), to the extent the pharmacist provides pharmacy services
relating to controlled substances.