Effective July 1, 2022, California pharmacies providing auto-refill services must:
- have a written policy and procedure describing the auto-refill program listing medications that may be refilled through the program;
- obtain patients’ written consent to auto-refills;
- provide a written notice to the patient summarizing the program and on how to withdraw from the program (such written notices must be available in the patient’s language of choice);
- complete a drug regimen review for each prescription refilled through the program at the time of refill;
- provide a written notification to the patient or patient’s agent confirming that the prescription medication is being refilled through the program each time the medication is refilled;
- allow the patient to withdraw a prescription medication from automatic refill or to disenroll entirely from the program;
- provide a full refund to the patient, patient’s agent, or payer for any prescription medication refilled through the program if the pharmacy is notified that the patient did not want the refill, regardless of the reason, and the pharmacy had been notified of withdrawal or disenrollment from the program prior to dispensing the prescription.
Our firm has prepared policies and procedures (and patient notices) that comply with the above requirements, available for download here.
If your pharmacy is located in another state or/and operates in other states, please keep in mind that many states do not permit auto-refill programs.
As to Medicare, part D beneficiaries can be enrolled into auto-refill programs but under certain circumstances, such as notice, opt-in and opt-out options, refunds for unwanted medications, etc. Basically, California law mirrors Part D requirements.
Many Medicaid programs have similar restrictions. Ensuring compliance with Medicare and Medicaid requirements is particularly important as non-compliance can lead to potential claims and actions against the pharmacy under the False Claims Act (which is very time-consuming and expensive to defended).
PBM manuals (see a related blog post) also require similar safeguards around 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.
Please contact our firm for any assistance with drafting or modifying policies and procedures regarding auto-refill programs.