Automatic refills is a landmine. Some states prohibit them outright. Medicare requires patient consent before each delivery. Most PBMs also place some conditions on auto-refills, such as obtaining authorization from the patient for each refill (to prevent fraud, waste and abuse and to ensure that patients receive only medications that they have requested). PBM manuals usually require pharmacies to complete a drug regimen review on all prescriptions filled as a result of the auto-fill program. Some PBM manuals even spell out proper procedures for auto-refill programs, such as:

• Auto-refill programs should be voluntary, on opt-in basis only;
• Patient consent is for refills only and shall not apply to any new prescriptions (new consent must be obtained);
• The pharmacy must provide patients with information on how to disenroll from its auto-fill program and must promptly respond to all disenrollment requests;
• The pharmacy must confirm at least annually that the patient still wishes to participate in the auto-refill program;
• The pharmacy must promptly discontinue automatic fill program upon notification that the patient entered a skilled nursing facility or elected hospice coverage.

Recently, California joined the states that place similar restrictions on auto-fill programs. This month, the California State Board of Pharmacy approved a new regulation that requires  pharmacies who offer auto-refills to comply with the following:

• to have written policies and procedures addressing the auto-refill program;
• to provide its patients with the information on how the program operates: instructions about how to withdraw a prescription medication from refill through the program or to disenroll entirely from the program. The patient or patient’s agent shall enroll by written, online, or electronic informed consent to participate in the program for each new prescription wherein there is a change in the prescription medication, strength, dosage form, or directions for use;
• to obtain annual renewal of each prescription from the patient or patient’s agent no later than 12 months after the prescription was enrolled in the program;
• to keeps a copy of the written or electronic informed consent to enroll on file for one year from date of dispensing;
• to complete a drug regimen review for each prescription refilled through the program at the time of refill;
• to provide a written or electronic notification to the patient or patient’s agent confirming that the prescription medication is being refilled through the program;
• to allow the patient to withdraw a prescription medication from automatic refill or to disenroll entirely from the program. The pharmacy shall document and maintain such withdrawal or disenrollment for one year from the date of withdrawal or disenrollment and shall provide confirmation to the patient or patient’s agent.
• to provide a full refund to the patient, patient’s agent, or payer for any prescription medication refilled through the program if the pharmacy was notified that the patient did not want the refill, regardless of the reason, or the pharmacy had been notified of withdrawal or disenrollment from the program prior to dispensing the prescription medication.

This new regulation, which becomes effective in 2022, mirrors PBMs’ requirements. Most pharmacies do not need to add anything to their compliance plan. If your pharmacy, however, does require assistance with drafting policies and procedures as required by this new regulation, please contact our firm directly: admin@pharmhealthlaw.com and we will be happy to help.