Back to School: How to Ace EpiPen® Billing and Avoid an Audit
PAAS National® has seen an increase in prescription validation requests and audits for EpiPen® and, with back-to-school in full swing, we want all pharmacy employees to be aware of potential billing issues for this life-saving medication.
According to section 1 Indications and Usage of the FDA product labeling, “EpiPen® and EpiPen Jr® are indicated for the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.”
Emergency medications are frequently audited, and EpiPens® have their own unique set of audit issues, including:
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- Quantity billed
- EpiPen® is billed as an “each”, so a 2-pack would be billed as “2 each”
- If multiple boxes of EpiPens® 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
- Mathematically calculable directions
- Directions that come over as “Use as directed” should generally 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
- 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
- Risk of audit recoupment for incorrect days’ supply is generally 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 an early refill.
- Product dispensed
- 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®
- 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.
- Prescriptions written generically as “Epinephrine (EpiPen)”, or with an NDC indicating EpiPen® (or an AB-rated generic), should be interpreted as EpiPen
Common EpiPen®/epinephrine NDCs, and their associated TE Codes, are as follows:
| Product | NDC | Manufacturer | FDA Orange Book TE Code | Marketing Category |
| EpiPen® 0.3 mg/0.3 mL | 49502-0500-02 | Mylan Specialty L.P. | AB | NDA |
| Epinephrine 0.3 mg/0.3 mL | 49502-0102-02 | Mylan Specialty L.P. | AB | NDA Authorized Generic for EpiPen® |
| Epinephrine 0.3 mg/0.3 mL | 00093-5986-27 | Teva Pharmaceuticals USA | AB | ANDA |
| Epinephrine 0.3 mg/0.3 mL | 00115-1694-49 | Amneal Pharmaceuticals | BX | NDA Authorized Generic for Adrenaclick® |
| Epinephrine 0.3 mg/0.3 mL | 80425-0264-01 | Advanced Rx Pharmacy of Tenn | BX | NDA Authorized Generic for Adrenaclick® |
| Auvi-Q® 0.3 mg/0.3 mL | 60842-0023-01 | Kaleo | BX | NDA |
| Product | NDC | Manufacturer | FDA Orange Book TE Code | Marketing Category |
| EpiPen Jr® 0.15 mg/0.3 mL | 49502-0501-02 | Mylan Specialty L.P. | AB | NDA |
| Epinephrine 0.15 mg/0.3 mL | 49502-0101-02 | Mylan Specialty L.P. | AB | NDA Authorized Generic for EpiPen Jr® |
| Epinephrine 0.15 mg/0.3 mL | 00093-5985-27 | Teva Pharmaceuticals USA | AB | ANDA |
| Epinephrine 0.15 mg/0.3 mL | 63629-8801-01 | Bryant Ranch Prepack | AB | ANDA |
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
- Clinical notes should include four elements:
- Date
- Name and Title of who you spoke with
- Summary of conversation
- Pharmacy employee initials
- Do not place emergency medications on auto-refill
I have a Bachelor of Arts in Communications from the University of Wisconsin – Madison. Prior to joining PAAS in 2017, I worked for Walgreens for 19 years.
As an Analyst at PAAS, I really enjoy being able to help independent pharmacies succeed. I have always been a fan of the underdog and am excited to be able to give you the tools you need to take on the giants of the PBM industry.
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