Recently, we have observed an unprecedented increase in the number of inspections carried out in pharmacies by the National Health Fund. Even minor infringements when dispensing prescriptions result in the imposition of severe financial penalties – from contractual penalties to demands for the full refund of reimbursements. For many pharmacy owners, this means a threat of bankruptcy. We explain why not every decision made by the National Health Fund is justified and how to defend yourself in court.
💡 Key takeaways
- The pharmacy makes money on the margin, not on the refund itself. When the National Health Fund orders a "repayment of undue reimbursement", the pharmacy owner must de facto to pay for a medicine out of their own pocket that was dispensed to a patient – leading to colossal losses.
- In Q2 2023 alone, the NFZ imposed fines and repayments on pharmacies totalling nearly 20 million zloty (average of over 240,000 PLN per inspected site!)
- In accordance with established court case law, minor formal irregularities that did not lead to the fraudulent acquisition of public funds, cannot be the basis for demanding the refund of the entire reimbursement amount.
- The defence process consists of three stages: submitting comments during the inspection itself, appealing to the President of the National Health Fund (NFZ), and ultimately, lodging a claim through ordinary (civil) court proceedings.
Decisions by the National Health Fund (NFZ) to reclaim undue refunds have a powerful destructive effect – the Fund generally deducts these sums from ongoing refund payments owed to the pharmacy, in practice, cutting the business off from its financial liquidity almost instantaneously. A swift court injunction to halt these deductions is a matter of life or death for many pharmacies.
NFZ inspections in pharmacies. A fight for the survival of pharmacies
Increased NHS inspections – statistics and common infringements
A grim picture for the pharmaceutical industry emerges from the official report of the National Health Fund Control Department for the second quarter of 2023. In just three months, the Fund questioned over 273,000 prescriptions, resulting in fines of almost PLN 20 million. The most frequent "sins" identified by officials include:
- Transmission of factually inconsistent data to the paper prescription in electronic communications.
- Taking more of the medication than prescribed by the doctor.
- Minor reporting errors (e.g., incorrect date of issue, wrong doctor or patient ID).
- Dispensing a prescription by a person allegedly not possessing the proper qualifications (e.g., by a technician instead of a pharmacist).
NFZ financial sanctions: Contractual penalty versus refund reimbursement
Sanctions affecting pharmacies fall into two categories:
- Penalty: This is due to a breach of the General Terms and Conditions for the Dispensing of Prescriptions (GTC). The penalty ranges from 200 zł to as much as 2% of the total reimbursement amount received by the pharmacy over the last several to several dozen months.
- Refundable return (Article 43(1)(6) of the Refund Act): A much deadlier instrument. It imposes an obligation to return to the National Health Fund (NFZ) the equivalent value of the medicines (with statutory interest) for all incorrectly disputed prescriptions within 14 days. For the pharmacy, this means out-of-pocket expenses for medicines correctly dispensed to patients.
Is a claim for reimbursement for formal defects justifiable? (Case law)
The NFZ often interprets regulations in a highly restrictive manner (so-called "blind formal rigour"), considering any typo in a report as grounds for returning the entire reimbursement amount. Such action is based on the assumption that not every entrepreneur will decide to undertake a costly and stressful legal process.
In case law (including in the Supreme Court's judgments of 9 March 2012, I CSK 216/11, and 21 April 2010, V CSK 358/09), a completely different stance has become established. The courts emphasise that Minor omissions made when dispensing prescriptions (formal errors) cannot form the basis for mass refusal of reimbursementRigourism is meant to protect public funds from fraud – if the medicine reached a person who is actually insured and actually ill, the state has fulfilled its constitutional obligation, and a pharmacist's formal error does not justify the confiscation of their property.
Stages of a pharmacy's defence in a dispute with the National Health Fund
1. Pharmacy check
Protective actions should be taken during the inspectors' visit. The pharmacy should immediately, based on Article 61p of the Act on Benefits, submit comprehensive statements and explanations. Often, thorough argumentation at this stage can limit the scope of findings in the post-inspection report.
2. Appeal to the President of the National Health Fund
Upon receiving the inspection report and the demand for repayment/penalty, the owner only has 14 days to lodge a formal objection with the President of the National Health Fund. Statistics show that the President of the National Health Fund (NFZ) generally (in over 80% cases) rejects them outright. This ‘administrative’ appeal route exhausts all options available to the authority itself.
3. Court Proceedings (Protection against set-off)
Claims from the National Health Fund (NFZ) for reimbursement are civil law disputes (they are settled by civil courts, not administrative ones). Referring the matter to court has strategic importance. Supported by law firms, pharmacy owners file applications for interim measures – asking the court to prohibited the Fund from deducting disputed amounts from current refunds until a legally binding judgment. Halting the "oxygen cut" allows the facility to survive a multi-month evidentiary process, in which statistics favour the pharmacies' arguments much more than those of the officials.
Summary
The NFZ treats penalty regulations as a constant source of funding for its budget, often detaching them from their supportive, preventive function. Entrepreneurs running pharmacies must actively resist at every stage – from the first minutes of inspection, through submitting comments, to professional representation in court.