PURPOSE: This rule establishes the regulatory basis to prohibit automatic refill of prescriptions by providers for MO HealthNet participants. This rule also establishes policies for Medication Synchronization Programs in the MO HealthNet Pharmacy program.

1. (1) Definitions.

   1. (A) Automatic Refill Program. Providers automatically refill prescribed medications, devices, or supplies at regular intervals without an explicit request from the participant, or the participant’s responsible party, for each refill.
   2. (B) Medication Synchronization Program. Designed to allow a participant to receive all maintenance medications on the same day. Before refilling any medications, the provider contacts the participant or the participant’s responsible party to detect any new, discontinued, or changed medications. The provider only refills those medications requested by the participant or the participant’s responsible party and coordinates pickup or delivery. Maintenance medications shall be as defined in 13 CSR 70-20.060.

2. (2) Automatic Refill Program.

   1. (A) MO HealthNet does not allow automatic refills or automatic shipments of medications, devices, or supplies. MO HealthNet does not pay for any prescription without an explicit request from a participant or the participant’s responsible party, such as a caregiver, for each refilling event. Participants and providers cannot waive the explicit refill request requirement and enroll in an automatic refill program.
   2. (B) A nurse or other authorized agent of the facility may initiate a request for a refill for a participant residing in a skilled nursing facility, group home, or assisted living arrangement.
   3. (C) Any prescription filled without a request from a participant or the participant’s responsible party may be subject to recoupment. Any provider who pursues an automatic refill policy may be subject to audit, claim recovery, suspension, or termination of their provider agreement.

3. (3) Medication Synchronization Program.

   1. (A) Documentation Required. The provider shall have written policies and procedures describing the Medication Synchronization Program which shall set forth, at a minimum, how the provider will comply with this section. The provider’s written policies and procedures for the medication synchronization program shall be provided to the Department of Social Services upon request. Providers that do not provide the written policies and procedures within three (3) business days of the department’s request may be subject to recoupment of any payments made to the provider by MO HealthNet for medications filled through the provider’s medication synchronization program.
   2. (B) Participant Enrollment. Before a participant enrolls, and annually thereafter, the provider shall provide a written or electronic notice summarizing the program to the participant or participant’s responsible party. Such notice shall include, at a minimum, instructions about how to withdraw a medication from refill through the program or to disenroll entirely from the program. The participant or participant’s responsible party must give the provider informed consent prior to enrolling in the Medication Synchronization Program, and annually thereafter.
   3. (C) Products Allowed. Medication Synchronization Program shall only include non-controlled substance maintenance medications and are not allowed to include controlled substances (CII–CV), medications for acute treatment, or medications used on an as-needed basis.
   4. (D) Medication Synchronization Program Contact. Providers with a medication synchronization program must contact the participant or the participant’s responsible party before refilling any medication and confirm each medication to be refilled to ensure an accurate medication list. Medication Synchronization Program providers which generate or contribute to fraud, waste, or abuse will be subject to potential recoupment of claims and potential sanction of the provider.
   5. (E) Record Keeping. The pharmacy shall keep a copy of the informed consent to enroll and annual informed consent to remain in the Medication Synchronization Program on file for five (5) years from the date of informed consent. Records of the medication synchronization program contact with the participant or the participant’s responsible party for the purposes of refilling medications must be kept for audit purposes, including the date and time of contact for five (5) years from the date of dispensing.
   6. (F) Penalties. Any prescriptions filled without a request from a participant or the participant’s responsible party may be subject to recoupment. Any provider who pursues a policy that includes refilling prescriptions on a regular date or any type of cycle fill, without meeting the specifications herein, may be subject to audit, claim recovery, or possible suspension or termination of their provider agreement.

AUTHORITY: sections 208.153, 208.201, and 660.017, RSMo 2016.* Original rule filed Dec. 15, 2022, effective July 30, 2023. *Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012; 208.201, RSMo 1987, amended 2007; and 660.017, RSMo 1993, amended 1995.