Proof of Patient Consent for a Refill Request: What You Need to Know

If you are a DMEPOS supplier billing Medicare Part B claims, then you should be familiar with the proof of refill request requirement. All DMEPOS items and supplies billed to Medicare Part B that are delivered or mailed require proof of refill request and an affirmative response to occur and be documented prior to shipment. PAAS National®’s Proof of Refill Request and Affirmative Response for DMEPOS Items form can be downloaded from the Member Portal.

For non-Part B claims, many PBM provider manuals include language requiring pharmacies to obtain (and retain) proof of member consent prior to delivery. However, enforcement of this requirement is often at the PBM’s discretion (i.e., variable). These policies, at least in part, originate from the 2020 CMS Call letter revisions concerning Part D Mail Order Auto-Ship Modifications. While PBM requests are uncommon, they may ask pharmacies to provide “proof of patient consent to refill” during audits‒ often catching pharmacies off guard. When PAAS National® sees this request, there is typically an underlying reason and it is a seemingly effortless way for the PBMs to recoup claims if the pharmacy does not have the proof. PBM audit algorithms are looking for Fraud, Waste and Abuse conducted by bad actors and will use data analysis as a reason to audit suspicious claims. See the PAAS Tips below for potential reasons why a PBM may ask for proof of refill request upon an audit, and how to ensure compliance of an automatic refill or medication synchronization program.

PAAS Tips:

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  • When does PAAS see these proof of refill requests on an audit?
    • Medicare Part B claims when an item is delivered or mailed
    • Pharmacies under an Investigative Review
    • Pharmacies located in a Health Care Fraud Prevention and Enforcement Action Team (HEAT) Zone -HEAT Zones are designated by CMS as having high rates of health care fraud
    • When there is a questionable patient/prescriber/pharmacy relationship that could occur via claims from telehealth
    • If there is a larger than average distance between patient/prescriber/pharmacy or if pharmacies are mailing to patients who live outside their normal delivery areas
    • Billing for high AWP items
    • Auto-refills (Many state Medicaid plans prohibit auto-refills)
    • Medication Synchronization – high-cost maintenance medications filled early every month
    • Beneficiaries complaining they received medications they did not order or need
    • Beneficiaries denying they requested medication due to the patient misunderstanding the request by the PBM
  • In particular, MedImpact has squeezed pharmacies for missing or invalid proof of member’s consent to fill or refill a prescription
    • MedImpact cites section 4.9 of the Provider Manual (requires a login)
  • Medicare Part B will deny and recoup a claim if the pharmacy does not have proof of refill request and affirmative response documented prior to the delivery or mailing of a DMEPOS item.
  • Avoid “automatic refills” and instead implement a “medication synchronization” program that includes a telephone check-in prior to medication billing and delivery to ensure the patient is still living at the same address, has not been hospitalized since last delivery (or had medication therapy changes), and confirms the needed medications prior to delivery

Jennifer Ottman, CPhT
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