PAAS National® continues to see a large number of EPIPEN® prescriptions flagged for audit, as well as targeted on OptumRx prescription validation requests. The PBMs often target EPIPEN® products due to their higher cost and confusion around proper billing practices and product substitution. Adhering to the guidance below can help avoid billing issues and reduce the risk of claim recoupment during an audit. 
1.  Quantity billed 
•  EPIPEN® is billed as an “each,” so a 2-pack would be billed as “2 each”
•  If multiple boxes of EPIPEN® auto-injectors are required at one time, it is advisable to verify with the prescriber why such a quantity is needed (e.g., one for home and one for school, one in each household, one for gym bag, school bag, and daycare, etc.) and make a clinical note on the prescription 
2.  Mathematically calculable directions
•  Directions that come over as “Use as directed” should be clarified with the prescriber as to whether the patient is to “use as directed per package instructions” in addition to updating the patient label directions accordingly
3.  Days’ supply
•  If a 2-pack is prescribed with directions indicating the patient may repeat the dose after a certain amount of time, billing a 1-day supply would be appropriate 
•  If a 2-pack is prescribed with directions that do not indicate a repeat dose, then a 2-day supply would be appropriate
•  The risk of audit recoupment for incorrect days’ supply is limited as PBMs have more tolerance for life-saving medications that are refilled on an as needed basis (rather than scheduled)
•  Additionally, the submission of a 1-day supply versus a 2-day supply is unlikely to impact patient copay, pharmacy reimbursement, or cause an early refill
4.  Product dispensed
a.  Epinephrine has many BX-rated products to EPIPEN®, and pharmacies need to obtain prescriber approval before dispensing one of these products if the prescription was written for EPIPEN®
i.  Conservatively, any indication on a prescription that a prescriber intended to prescribe EPIPEN® (or its AB-rated generics) should be clarified before dispensing a BX-rated generic
ii.  Prescriptions written generically as “Epinephrine (EPIPEN®),” or with an NDC indicating EPIPEN® (or an AB-rated generic), should be interpreted as EPIPEN®
PAAS Tips: 
•  Clarify quantities if missing the unit of measure (each) or if the unit of measure is “unspecified”
•  Clarify directions if ambiguous or “use as directed”
•  Ensure the patient label directions match any clarification with the prescriber
o  Clinical notes should include four elements: 
1.  Date and time
2.  Name and Title of who you spoke with
3.  Summary of conversation
4.  Pharmacy employee initials
•  Do not place emergency medications on auto-refill

By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

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