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Recently, more and more owners of community pharmacies and pharmacy points have been reporting to our Law Firm seeking help in their unequal fight against the National Health Fund, which, as a result of inspections, often imposes enormous financial penalties on them, consisting of the obligation to refund received subsidies or pay contractual penalties, which for many of them means the end of their dreams of a well-performing business, and sometimes even the necessity of closing the pharmacy. By way of introduction, it should be mentioned that a subsidy is a supplement from the National Health Fund to the amount that the patient must pay for a reimbursed medicine or other product, largely covering the costs that the pharmacy incurs when ordering these products from wholesalers. In other words, pharmacies do not profit from reimbursed medicines – the revenue from subsidies does not primarily go into the pocket of the pharmacist selling medicines, nor to the pharmacy owner. However, after inspections carried out by the National Health Fund, it is precisely the latter who is often obliged to refund the undue subsidy in full. In short, the pharmacy owner is expected to pay out of their own pocket for a medicine dispensed to a patient – often several, a dozen, tens, or even hundreds of thousands of zlotys.

An increasing number of inspections and financial sanctions imposed - intensified activities of the National Health Fund

According to the report on the activities of the Control Department for the second quarter of 2023 published by the National Health Fund on September 18, 2023 - within three months, the National Health Fund carried out a total of 682 inspections and verification activities, of which 175 of them related directly to the implementation of the contract. for dispensing reimbursed medicines, foodstuffs for particular nutritional uses and medical devices on prescription in pharmacies and pharmacy points[1]During an audit, the National Health Fund identified shortcomings in the processing of a total of 273,746 reimbursed prescriptions submitted for inspection. This resulted in financial penalties and an obligation to repay reimbursements totalling PLN 19,724,884. When broken down per inspection, this amounts to a significant PLN 240,547. The most common shortcomings identified by the inspectors were:

1. forwarding to the OW NFZ in electronic messages data that is inconsistent with the actual state of affairs regarding filled prescriptions found in pharmacies;
2. dispensing more drug than indicated in the dosage method or in the absence of a given dosage method;
3. failure to report or incorrect reporting of the date of prescription, patient's additional entitlements; identifier of the uninsured person entitled to health care services, identifier of the National Health Fund branch, identifier of the person dispensing the prescription, information on the issuance of a substitute and the EAN code of the prescribed drug, EAN/GTIN code of the ingredient of the prescription drug, pro familiae annotation;
4. filling a prescription by a person who does not have the qualifications and authorizations to fill it.

Financial sanctions – legal basis

Financial penalties imposed by the National Health Fund as a result of shortcomings identified during inspections can generally be divided into two categories: 1) repayment of undue reimbursement and 2) obligation to pay a contractual penalty. The obligation to refund reimbursement has been regulated by the legislator in Art. 43(1)(6) of the Act of 12 May 201

“1. In order to provide the services covered by the prescription fulfillment contract, the pharmacy is obliged to: (...) 6) refund the price of the medicine, food for special nutritional purposes, medical device, including statutory interest for delay, calculated from the date on which the refund was paid to the date of its return, within 14 days from the date of receipt of the request for payment, if as a result of verification or inspection of the information referred to in point 2, or the inspection referred to in points 3 and 4, it is found that the prescription was filled in violation of the provisions of the Act, provisions on health care services financed from public funds, provisions of the Act of September 6, 2001 - Pharmaceutical Law and provisions on the professions of doctor and dentist.

The obligation to pay a contractual penalty is based on the regulation of the Minister of Health of December 8, 2011 on the general terms and conditions of contracts for the supply of prescriptions and the framework template for a contract for the supply of prescriptions (consolidated text: Journal of Laws of 2021, item 337). The entire chapter 4 of the General Terms and Conditions is devoted to regulating this issue. Pursuant to the content of § 8 section 1 of the annex to the above-mentioned regulations:

“1. In the event of non-performance or improper performance of the contract for the supply of prescriptions, resulting from circumstances for which the entity running the pharmacy is responsible, the President of the Fund or the director of the provincial branch of the Fund referred to in § 1 section 2, imposes a contractual penalty.”

The amount of the contractual penalty depends on the type and seriousness of the identified deficiencies and may range from PLN 200 to PLN 2 % of the amount of reimbursement received by the pharmacy - for a period of twelve to even twenty-four settlement periods from the moment of violation of the prescription fulfillment contract.

Refund of undue refund pursuant to Art. 43 section 1 point 6 of the Reimbursement Act - Is it always justified?

The most severe financial sanction imposed on pharmacies due to its size is undoubtedly the refund of undue refunds, because as a result of its imposition, the pharmacy bears the cost of product reimbursement, which, under the Constitution of the Republic of Poland, is the responsibility of the Polish state, generating huge and unexpected costs for the pharmacy.[2]. At the same time, the National Health Fund generally deducts the sanction imposed in this way from the refunds due to pharmacies for subsequent settlement periods pursuant to Art. 46 section 1 of the Reimbursement Act, thus depriving them of funds to conduct their current activities. From this point of view, the key issue is the answer to the question whether the return of undue refund is justified in every case of deficiencies found by the inspection body? From the literal wording of the above-mentioned regulation of Art. 43 section 1 point 6 of the Refund Act, it might seem that basically every violation of the provisions mentioned therein, as well as implementing acts in the form of, among others, regulation of the Minister of Health on prescriptions, may lead to imposing on the pharmacy operator an obligation to return the refund received along with statutory interest for delay from the moment of its receipt. However, this kind of interpretation is completely wrong. This understanding of the regulations is in clear contradiction with the established jurisprudence of both the Supreme Court and common courts - which, however, does not stop the National Health Fund from demanding reimbursement from pharmacies even in the most trivial cases. The National Health Fund benefits from the fact that not all people affected by financial sanctions decide to appeal and go to court.  It should be emphasized that the sanction provisions introduced by the legislator into the Reimbursement Act cannot be read without taking into account the purpose they are to fulfill in legal transactions from the perspective of the refund system, for ensuring which under Art. 68 section 2 of the Constitution of the Republic of Poland, state authorities are responsible. In order to correctly decode the content of these provisions, it is necessary to determine the meaning of the refund itself, which will allow us to fully understand the conditions for their application.

Court decisions

As the Supreme Court aptly explained in its judgment of January 4, 2007:

“Reimbursement (…) is an element of the universal health insurance system. The need to ensure universal and equal access to medical services for all includes not only the services provided by doctors or health care facilities, but also the state guarantee - resulting indirectly from Art. 68 of the Constitution - citizens' access to cheaper supplies of medicines that do not take into account pure economic calculation. The function of reimbursement is therefore to compensate pharmacies for the difference between the market price of the drug (medical material) and its retail price for the insured consumer who purchases the drug (medical material) at a much lower price or - in special cases - free of charge.[3].

In the light of the above, there is no doubt that since the basic purpose of reimbursement is for the state to provide eligible citizens with access to cheaper supplies of medicines, the sanction provisions should be ancillary to securing such a specific goal. Therefore, in order to read the correct normative meaning of Art. 43 section 1 point 6 of the Reimbursement Act cannot be limited only to its literal aspect. Such a reading of the legal text is in complete contradiction with the derivational concept of legal interpretation adopted in the doctrine and case law and disregards the location of a given norm in the entire system and the function that this norm is to fulfill - removing from the interpreter of the legal text any obligation to interpret the provision and thus constituting the implementation of "a principle harmful to citizens and dangerous to decision-makers clara non sunt interpretanda"[4]The Supreme Court rightly noted this issue as early as in its ruling of 21 April 2010, unequivocally stating that "Minor, correctable shortcomings in the execution of prescriptions do not constitute grounds for refusing reimbursement of the price of medicines or medical products, as provided for in Article 63(1) of the Act of 27 August 2[5]The Supreme Court subsequently reached the same conclusions in its ruling of 9 March 2012, emphasising that: "(...) one should not, however, lose sight of the purpose for which the Act lays down strict requirements for issuing prescriptions and dispensing medicines on their basis. First and foremost, this is to ensure patient safety. As far as reimbursed medicines are concerned, the aforementioned strictness is intended to prevent public funds from ending up with an unauthorised person. Therefore, the assessment of formal defects in a prescription should take into account the purpose which this formalism serves."[6]With a few exceptions, the above position can be considered established in the case law of common courts as well. By way of example, we refer readers to the judgment of the Court of Appeal in Szczecin of 29 January 2019.[7] and the judgment of the District Court in Łódź of July 24, 2020.[8], in which there was a strong argument for the necessity of the supervisory body weighing individual infringements found during the inspection before making a decision to impose such far-reaching financial sanctions as the obligation to repay reimbursements to the pharmacy operator. Supplementing the above arguments, it should be noted that the National Health Fund also has other types of disciplinary actions in case of irregularities, and consequently, the imposition of financial sanctions, often leading to the collapse of businesses – should be treated as ultima ratio and used only in situations where, as a result of incorrect prescription fulfillment, the reimbursement system has become unsealed or control of funds paid as part of the refund is impossible. In any other case, the inspection body should limit itself to formulating appropriate post-inspection recommendations in accordance with Art. 61s section 2 point 2 of the Act of 27 August 2004 on health care services financed from public funds (i.e Laws 2022 item 2561 – Benefits Act). At least the first time.

Obligation to return the refund - what are the stages of such a case? 

Pharmacy inspection

It should be emphasised here that pharmacy operators are not defenceless against actions taken by the National Health Fund (NFZ) and have a range of procedural instruments available to protect their interests – however, this requires swift and consistent action, which is best initiated during the inspection of the pharmacy. From our experience, during the NFZ inspection itself, the inspected entity is usually asked to submit relevant documents and explanations, which can be the first step in taking effective action to defend against future financial consequences. Even if no such request is made, under Article 61p of the Act on Benefits, anyone, including a pharmacy operator, may submit statements to the inspectors concerning the subject of the inspection. Well-prepared explanations can influence the final decision of the inspection authority regarding the scope of obligations imposed in the post-inspection report, or at least prepare the ground for further stages of defence.

ABOUTcalling the president of the National Health Fund - raising objections to the post-audit report

If the National Health Fund completes the inspection and, finding specific deficiencies in the post-inspection report, imposes financial sanctions on the pharmacy - then the manager of the inspected entity, i.e. the manager of the pharmacy, has the right to raise objections to the post-inspection report within 14 days from the date of its delivery. These objections should be submitted to the President of the Fund through the appropriate branch of the National Health Fund that carried out the inspection. The President of the National Health Fund should consider the objections raised within the next 14 days and, if the pharmacy's position is taken into account, may change the post-inspection statement in whole or in part, including the financial consequences. [9]As indicated by the introduction to the activity report of the Control Department, in the second quarter of 2023, the audited entities submitted 83 objections to the assessments and conclusions contained in the post-audit reports. In the same period, 93 objections were considered, of which only 17 were partially upheld and one was fully upheld. The failure to address objections to the post-audit report by the President of the NFZ closes the administrative defence route for pharmacies against the demand for reimbursement, but this does not mean that it is the end of the fight for a fair resolution.

Lawsuit

In the next steps, pharmacies affected by the imposed financial sanctions have an open path to court proceedings. Importantly, the case law has determined that the claims of the National Health Fund for reimbursement are of a civil law nature, and therefore the jurisdiction of administrative courts is excluded in this respect.[10]At the same time, it must be emphasised that taking legal action as soon as possible is crucial from the perspective of protecting the pharmacy's financial interests – this often allows the National Health Fund (NFZ) to avoid offsetting the claimed receivables against the refunds due to the pharmacy for subsequent settlement periods. Our experience shows that with a correctly drafted application, courts often agree with the arguments put forward by law firms representing pharmacies, and frequently (though not always) prohibit the NFZ from making deductions of the claimed contractual penalty and the refund of undue reimbursement until a legally binding decision is made on the case – one way or another. At the same time, court statistics are fortunately significantly better for pharmacies than when the case is handled solely by the NFZ. Although, of course, court cases can be full of pitfalls and seemingly easy routes to success, hence they require skilful handling.

Summary

To sum up the above, it should be emphasized that the activities of the National Health Fund, which we have been observing for a long time, consist in imposing high financial sanctions in the form of contractual penalties and the obligation to return undue refunds to entities operating pharmacies, even in the event of finding extremely trivial deficiencies that do not lead to an actual leakage of the reimbursement system - have no legal basis and are in contradiction with the mission of the National Health Fund, which is intended to be an institution supporting the development of the health care system, but at the same time acting to ensure appropriate availability and quality of health care services, including: by building good relationships with healthcare providers[11]After years of observation, we note with regret that the cause of this state of affairs is not only imprecise legislation but also the approach of supervisory bodies, which appear to be improperly tasked. Currently, the actions taken

Authors: Antoni Skoczek, Piotr Kłodziński

See also the article about the results of our work: https://klodzinskikancelaria.pl/nfz-nie-ukarze-aptek-za-sprzedaz-lekow-przez-technikow/

 [1] https://www.nfz.gov.pl/o-nfz/kontrole-nfz/sprawozdanie-z-dzialalnosci-departamentu-kontroli-za-ii-kwartal-2023-r-,6431.html[2] M. Czarnuch, [In:] M. Pieklak (ed.), Act on the reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices. Comment, Warsaw 2014, comm. to art. 43 Nb. 17 [3] Judgment of the Supreme Court of January 4, 2007, V CSK 388/06, OSNC 2007, no. 12, item 183. [4] A. Choduń, M. Zieliński, Justification of interpretative statements from the perspective of the derivational concept of legal interpretation, Archiwum Filozofii Prawa i Filozofii Społecznej 2020/2, p. 8. [5] Supreme Court judgment of 21 April 2010, V CSK 358/09, OSNC – Additional Collection 2011 No. A, item 3, p. 16. [6] judgment of the Supreme Court of March 9, 2012, I CSK 216/11, OSNC 2012 no. 9, item 41. [7] judgment of the Court of Appeal in Szczecin of January 29, 2019, I ACa 335/18, Legalis no. 2180919. [8] judgment of the District Court in Łódź of July 24, 2020, III Ca 1516/19, LEX no. 3157872. [9] Pietraszewska-Macheta Agnieszka (ed.), Act on health care services financed from public funds. Commentary, Lex 2023, comm. to art. 61t Nt. 3 [10] resolution of the Supreme Court of December 5, 2014, III CZP 93/14, OSNC 2015 No. 10, item 114, p. 18; judgment of the Supreme Court of January 4, 2017, V CSK 388/06, OSNC 2007 no. 12, item 183, p. 45; [11] Assumptions for the strategy of the National Health Fund for 2019-2023.