Specialty Pharmacy Compliance During COVID-19 Pandemic

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The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty pharmacies grappling with servicing patients in the face of the COVID-19 pandemic. However, there may be some relaxation of prior authorization and fill limit requirements.

In addition, logistics providers such as FedEx and UPS suspending signature requirements could affect specialty pharmacies’ compliance with payor contracts. Here is what you need to know:

Refill Too-soon/Emergency Refills

The CMS Memo notes that Part D and Medicare-Medicaid Plan sponsors may take several permissible actions to ensure pharmacy access during a state of emergency, such as relaxing “refill-too-soon” edits, reimbursing for extended days’ supply of prescription drugs, and reimbursing enrollees for prescriptions obtained from out-of-network pharmacies.

However, there is no requirement that insurance plans take these steps. At least 20 states currently have laws that permit pharmacists to authorize prescription refills for emergencies when they have been unable to obtain authorization to refill from a healthcare provider, but the drugs permitted for refills and the quantities that may be dispensed in an emergency vary by state. Specialty pharmacies may reach out to payors and seek permission to submit such emergency fills for reimbursement, but there is no guarantee a payor will honor the request.

Prior Authorizations

The CMS Memo also reminds Medicare Advantage Organizations and Part D Sponsors that they may choose to waive prior authorization requirements for Part D drugs or services related to COVID-19, if or when such drugs, tests, or services are identified. Any such waiver must be provided uniformly to similarly situated enrollees who are affected by the emergency. However, the implications for specialty pharmacies at this time remain speculative, as these prior authorization waivers only apply to drugs or services used to treat or prevent COVID-19, which are still developing. Additionally, prior authorization requirements generally are created at the plan’s discretion and therefore could be waived without CMS prompting.

Home and Mail Delivery

The CMS Memo further provides that Part D and Medicare-Medicaid Plan sponsors may voluntarily provide home or mail delivery of Part D drugs. In situations where it may be difficult for patients to get to a retail pharmacy, or in quarantine situations, sponsors are permitted to voluntarily relax any plan-imposed policies that discourage mail or home delivery. However, this CMS permission is not likely to result in any flexibility for specialty pharmacies related to mail order activity.

Signature Requirements

Some logistics providers, such as FedEx, have temporarily suspended requiring signatures upon delivery in the United States for the majority of deliveries, permitting the recipient to decline signature in which case the driver would make a note (typically shown as C19) on the signature pad.

Payors, as a matter of contract, routinely require specialty pharmacies to obtain evidence of delivery, which is most often supported by signature confirmation. Some payors permit signature logs as evidence of documentation, which arguably may be met by the current driver notation protocol. While we have not seen widespread payor response to this change, at least one PBM, Express Scripts, has issued a network bulletin establishing alternative methods to meeting the evidence of delivery requirements.

Key Takeaways for Specialty Pharmacies

We recommend specialty pharmacies monitor payor bulletins and provider manuals closely for more information. In the absence of payors expressly waiving signature requirements, specialty pharmacies may consider taking further actions such as requesting a written attestation of delivery from patients, verbally confirming receipt and retaining documentation of the conversation, ensuring there is documentation of patients requesting delivery of each prescription, and notating reason for unavailability of the signature in the pharmacy record. In addition, specialty pharmacies should consider direct calls to key payors with a history of auditing evidence of delivery.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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