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Gilead recently notified pharmacies that beginning January 1, 2022, they must enter into a participation agreement in order to submit claims and receive reimbursement under Gilead’s Patient Assistance Program and Medication Assistance Program (PAP/MAP).  The notice from Gilead includes the network participation agreement.  Under that agreement, Gilead will only pay participating pharmacies, both in-house and contract pharmacies, the 340B acquisition cost for claims for PAP/MAP patients, even if the pharmacy submits a claim for a drug purchased at a non-340B price.  Other pharmacies that are not participating in the 340B program are paid at wholesale acquisition cost (WAC).  To obtain WAC pricing for drugs that are purchased at non-340B prices, pharmacies that participate in the 340B program have to file an “acquisition cost appeal” to Gilead with supporting documentation.  The agreement does not state that covered entities may directly file an acquisition cost appeal, but that may be an oversight by Gilead.  In addition to the 340B acquisition cost, Gilead will pay pharmacies a $2.75 dispensing fee and an $80 administrative service fee for each prescription.  Gilead’s payment to contract pharmacies at 340B acquisition cost for all of Gilead’s applicable drugs apparently applies regardless of whether the prescription is dispensed to a 340B patient.  This apparently will require a community or specialty contract pharmacy that dispenses a significant number of Gilead drugs to non-340B PAP/MAP patients to submit appeals for each of those claims.  Gilead is permitting pharmacies to aggregate claims and submit batch appeals.  Batch appeals must include the member ID, group ID, prescription number, date of service, pharmacy NPI, claim ID, the prescription’s written date, and the prescriber’s NPI.  340B community members are concerned that Gilead’s new payment policy may discourage retail pharmacies from participating in the 340B program as contract pharmacies due to the administrative burden of submitting appeals for non-340B claims.

Other terms of the agreement state that pharmacies must  provide Gilead’s products to patients free of charge, submit claims to Gilead’s processor using certain claims processing information, notify Gilead of, and cooperate with, patients that file professional liability claims against the pharmacy, maintain a signature log for medications that have been dispensed, maintain applicable records for at least seven years, and permit Gilead or its PAP/MAP administrator to inspect or audit applicable pharmacy records.  If, through such an audit, a pharmacy is found to have improperly submitted claims to the PAP/MAP, the pharmacy must provide sufficient documentation to verify the claim within thirty days or face repayment to Gilead.

In addition to the new participation agreement, Powers has learned that Gilead has sent notices to some 340B covered entities informing them that, effective immediately, Gilead will only fill prescriptions for PAP/MAP patients if the covered entity sends the prescription to Gilead’s designated mail-order pharmacy.