By Harini Bupathi, Esq.
Partner, Frier Levitt – Life Sciences Practice Group
Earlier this year, biopharmaceutical company AstraZeneca issued notices to pharmacies regarding data discrepancies concerning Farxiga. The notices request detailed documentation relating to dispensing and purchasing activity during 2024 and now extend into 2025.
Notably, on January 3, 2024, the generic dapagliflozin entered the market. With generic availability, AstraZeneca’s correspondence reflects heightened scrutiny over whether pharmacies dispensed branded Farxiga or its generic equivalent, and whether billing accurately reflected what was dispensed.
Pharmacies receiving these letters should understand their obligations and carefully evaluate how to respond. Engaging experienced legal counsel early is strongly advised.
Background and What’s New
In prior rounds, AstraZeneca asserted it identified “dispensing discrepancies” by comparing claims-level data to pharmacy purchase histories. These letters often cite inconsistencies involving strength, quantity, days’ supply, or National Drug Code (NDC) usage and request documentation to reconcile those differences.
While earlier correspondence focused on 2024 claims, the newest communications expand the review period into 2025 and seek more granular proof tied to specific claims.
What the letters typically request:
- Wholesaler purchase documentation sufficient to reconcile dispensing activity
- Dispensed quantities of Farxiga during the review period
- Claim-level explanations for any discrepancies identified
Key Risk Areas Emerging from Recent Letters
- NDC selection and interchangeability. Billing must reflect the actual product dispensed. Dispensing a generic while billing the brand may trigger scrutiny and potential repayment exposure.
- Prior authorization and DUR overrides. Missing pharmacist notes or prescriber confirmations can create compliance risk.
- Purchase-to-dispense reconciliation. Disparities during backorders or substitutions often invite deeper inquiry.
Immediate Actions for Pharmacies
Pharmacies receiving an AstraZeneca letter should:
- Calendar all response deadlines immediately
- Confirm the scope of claims and date ranges under review
- Assemble complete documentation for each queried claim
- Verify that the NDC dispensed matches the NDC billed
- Reconcile wholesaler purchases with dispensing records
Understanding the Obligation to Respond
While pharmacies may not have a direct contractual relationship with AstraZeneca, responses can have downstream consequences involving PBMs, payors, CMS, and state regulatory agencies such as a State Board of Pharmacy.
Information provided to a manufacturer may later be relied upon by PBMs or regulators. Pharmacies should exercise caution and seek guidance before responding.
Outlook
AstraZeneca’s letters reflect a broader trend of manufacturers conducting independent reviews of pharmacy billing and purchasing practices. Pharmacies should ensure accurate claims submission, proper documentation, and sufficient inventory support for billed prescriptions.
A prompt, thoughtful response strategy can materially affect the trajectory and outcome of these reviews.
About the Author:
Harini Bupathi, Esq. is a Partner at
Frier Levitt
practicing in the firm’s Life Sciences group. Her practice focuses on counseling pharmacy providers
on PBM relationships, audits, recoupments, and fraud, waste, and abuse investigations.
