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MassHealth Guidelines for Medical Necessity Determination for Maternal Cell-Free DNA Testing

These Guidelines for Medical Necessity Determination (Guidelines) identify the clinical information that MassHealth needs to determine medical necessity for noninvasive prenatal testing (NIPT) through analysis of cell-free DNA (cfDNA) in maternal blood.

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Guidelines for Medical Necessity Determination for Maternal Cell-Free Fetal DNA Testing for Aneuploidy

These Guidelines for Medical Necessity Determination (Guidelines) identify the clinical information that MassHealth needs to determine medical necessity for noninvasive prenatal testing (NIPT) through analysis of cell-free DNA (cfDNA) in maternal blood. The majority of cfDNA in maternal blood originates from the mother herself, however about 10-20 percent is composed of fetal DNA originating from the placenta and freely circulating in maternal plasma, also known as cell-free fetal DNA (cffDNA) and can be indicative of aneuploidy risk. These Guidelines are based on generally accepted standards of practice, review of the medical literature, and federal and state policies and laws applicable to Medicaid programs. 

Providers should consult MassHealth regulations at 130 CMR 401.000, 433.000, and 450.000; Subchapter 6 of the Independent Clinical Laboratory Manual; and Subchapter 6 of the Physician Manual for information about coverage, limitations, service conditions, and prior authorization (PA) requirements. 

Providers serving members enrolled in a MassHealth-contracted accountable care partnership plan (ACPP), managed care organization (MCO), integrated care organization (ICO), senior care organization (SCO), or program of all-inclusive care for the elderly (PACE) should refer to the ACPP’s, ICO’s, MCO’s, SCO’s, or PACE’s medical policies for covered services. 

MassHealth requires PA for maternal cfDNA testing. MassHealth reviews requests for prior authorization on the basis of medical necessity. If MassHealth approves the request, payment is still subject to all general conditions 

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