Section 406.442 - Controlled Substance Management Program(A)Introduction. The MassHealth agency has established a Controlled Substance Management Program for MassHealth members who over utilize or improperly utilize prescribed drugs. Members in the Controlled Substance Management Program are restricted to obtaining prescribed drugs only from the provider that the MassHealth agency designates as the member's primary pharmacy.(B)Criteria for Member Enrollment. The MassHealth agency may enroll in the Controlled Substance Management Program those MassHealth members who meet one of the following criteria:(1) members whom the MassHealth agency determines over-utilize or improperly utilize medications in certain therapeutic classes, receive duplicative therapy from multiple physicians, or frequently visit the hospital emergency department seeking pain medications. The MassHealth Drug Utilization Program will identify criteria to identify members for the Controlled Substances Management Program. These criteria will be listed in the MassHealth Drug List; or(2) members who were enrolled in the Controlled Substance Management Program of a MassHealth-contracted managed care organization (MCO) at the time the member disenrolled from the MCO. When the MassHealth agency enrolls a member in the Controlled Substance Management Program it notifies the member accordingly.(C)Service Restriction.(1) Except as outlined in 130 CMR 406.442(B), members enrolled in the Controlled Substance Management Program may obtain prescribed drugs only from the member's primary pharmacy as designated by the MassHealth agency, and only the member's primary pharmacy may receive payment from the MassHealth agency. Members who are enrolled in this program will be identified by the Eligibility Verification System (EVS) as participants in the Controlled Substance Management Program.(2) The MassHealth agency authorizes a pharmacy other than the primary pharmacy to dispense a nonrefillable supply of a drug to a restricted member when the pharmacist has determined that the member's health or safety would be jeopardized without immediate access to that drug or if the prescription is for family planning.(D)Responsibilities of Primary Pharmacy. The primary pharmacy must monitor the prescription utilization pattern of each member, and must exercise sound professional judgment when dispensing all prescription drugs. When the pharmacist reasonably believes that the member is presenting a prescription that is inappropriate for his or her medical condition, the pharmacist must contact the prescriber to verify the authenticity and accuracy of the prescription presented. Primary pharmacies that are found on review to be dispensing drugs in a manner that is inconsistent with professional standards may be subject to administrative action by the MassHealth agency, including the recovery of payments and the imposition of sanctions, in accordance with 130 CMR 450.000: Administrative and Billing Regulations.(E)Change in Primary Pharmacy and Member Status. (1) The member may ask MassHealth to change the member's primary pharmacy designation only once per calendar year, unless the member can demonstrate that the designated primary pharmacy is unable to address the member's pharmacy needs due to a change in (a) the member's residence;(b) the member's medical condition; or(c) the primary pharmacy's business practices.(2) The MassHealth agency may disenroll or transfer a member from a primary pharmacy if the pharmacy requests the change.(3) The MassHealth agency periodically reviews the member's drug utilization on its own initiative, or upon the member's request, but no earlier than 12 months after the date on which the MassHealth agency enrolled the member in the Controlled Substance Management Program. If, after such review, the MassHealth agency determines that the member has not used excessive quantities of prescribed drugs for at least that 12-month period, the MassHealth agency will disenroll the member from the Controlled Substance Management Program and the member will no longer be subject to the restrictions of that program. However, the MassHealth agency may reenroll a member in that program at any time in accordance with the provisions of 130 CMR 406.442(B).Amended by Mass Register Issue 1319, eff. 8/12/2016.Amended by Mass Register Issue 1461, eff. 1/21/2022.Amended by Mass Register Issue 1511, eff. 1/1/2024.