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Office of the Inspector General Releases Advisory Opinion on Specialty Pharmacies
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The Office of the Inspector General (OIG) has released an Advisory Opinion holding that specialty pharmacies entering into contracts with retail pharmacies for referrals and to compensate retail pharmacies for providing other services to patients would violate the anti-kickback statute.

Please review IACP's summary of this OIG opinion directly below.

Please click here to review the full OIG Advisory Opinion.



Office of Inspector General
Advisory Opinion (No. 14-06)
SUMMARY


Please note that Advisory Opinions are restricted only to the facts that the decision is based upon.  Advisory Opinions, therefore, cannot be relied upon by any individuals other than the individual requesting the Advisory Opinion.  Instead, Advisory Opinions only shed insight into an Agency’s current thinking on a particular subject while offering guidance on the specific facts of the individual requesting the Advisory Opinion.

The Office of Inspector General (OIG) released an advisory opinion (No. 14-06) regarding whether the specialty pharmacy requesting the advisory opinion would be in violation of the anti-kickback statute where the specialty pharmacy entered into contracts with retail pharmacies and would provide retail pharmacies a fee for providing various support services.

Under the scenario given, the specialty pharmacy would enter into contracts with various local pharmacies and pharmacy networks in order to help patients obtain specialty drugs from the specialty pharmacy.  In return, the specialty pharmacy would compensate the retail pharmacies the fair market value for providing other services to the patient such as: accepting new specialty drug prescriptions from patients or their prescribers; gathering patient and prescriber demographic information; recording patient-specific medication history and use, including drug names, strength, and directions; counseling patients on appropriate use of their medications; informing the patients about specialty drug access and services generally provided by specialty pharmacies; obtaining patient consent to forward the specialty drug prescription to the specific specialty pharmacy; and providing ongoing assessments for subsequent refills.  

OIG held that the proposed arrangement would propose more than a minimal risk of fraud and abuse and thus violate the anti-kickback statute as the amount of Per-Fill Fees the retail pharmacy would receive would be tied directly to the number of patients with specialty drug prescriptions that the retail pharmacy referred to the specialty pharmacy.

The OIG Advisory Opinion also noted that it is skeptical of the specialty pharmacy’s claims that local pharmacies “sometimes lack the information necessary to direct a patient to a pharmacy with the ability to dispense a specialty drug” noting that such information should be readily available.   In addition, OIG stated that the specialty pharmacy is allowed to notify retail pharmacies of its services without compensating the retail pharmacies in exchange for referrals.

Please email IACP at iacpinfo@iacprx.org with any questions.

8/2014

 

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