Control from the National Health Fund – control of reimbursed prescriptions, appeals, reimbursement

Krzysztof Bardel|
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Inspection by the National Health Fund – what does the inspection of reimbursed prescriptions look like? What to do when the National Health Fund demands a refund? 


In recent years, the pharmaceutical and medical community has heard justified complaints about the control proceedings conducted by the National Health Fund regarding the prescription and implementation of reimbursed prescriptions. First of all, they concern contractual penalties imposed by the National Health Fund.

The National Health Fund's practice of imposing penalties and reimbursement obligations as part of these inspections may seem potentially impossible to combat, but in reality it is otherwise. There are effective defenses.

In the article - based on our considerable experience in handling this type of cases, in addition to encouraging the use of professional, experienced legal services as soon as possible - for example (but not only) provided by Chancellery – we present (to interested parties – including other lawyers) – how to defend pharmacists and doctors against the effects of overzealous inspections – especially where the National Health Fund demanded a refund. 

Every pharmacist knows the fact that the National Health Fund carries out pharmacy inspections from time to time. Doctors are inspected by the National Health Fund slightly less frequently. Sometimes they are more selective and targeted at the prescription of specific products - and sometimes the National Health Fund, when inspecting a doctor, checks the entire quality of keeping patients' medical records.

The pharmacist is obliged to:

  1. collect and provide the Fund with reliable and accurate information contained in the content of individual prescriptions for reimbursed medicines, foodstuffs for particular nutritional uses, and medical devices;
  2. make available for inspection by the entity obliged to finance services from public funds the documentation that the pharmacy is obliged to keep in connection with the implementation of the contract, and provide explanations in the scope related to the implementation of reimbursed prescriptions;
  3. make available for inspection by the entity obliged to finance health care services from public funds, within the deadline specified by this entity, information on the content of each contract, including arrangements made in any form, between a pharmacy and a pharmaceutical wholesaler, the purpose of which is the purchase of medicines, foodstuffs special nutritional purposes, medical products;

Similar obligations apply to doctors - they are usually (depending on the nature of cooperation with a given medical entity) obliged, as part of medical prescription control, to present complete patient documentation justifying the prescription of specific medications to patients.

The very fact of carrying out inspections is not particularly controversial, but the way in which the National Health Fund has been operating recently may raise doubts. The National Health Fund often uses a special tactic - during pharmacy inspections, it calls on the pharmacy manager to present several dozen prescriptions with the highest reimbursement value from the last few years. The method of selecting prescriptions is not accidental - after all, the higher the reimbursement amount, the higher the penalty claimed by the National Health Fund for formal irregularities. And according to the National Health Fund, these are not difficult to obtain; even the slightest oversight, according to the National Health Fund, should justify a request for a refund.

The National Health Fund's control of prescriptions with the highest reimbursement value is important due to the content of Art. 43 section 1 point 6 of the Refund Act. According to its wording: "In order to provide the services covered by the prescription fulfillment contract, the pharmacy is obliged to refund the price of the medicine, food for special nutritional purposes, medical device, together with 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.

This means that in the event of irregularities in the performance of the prescription contract, e.g. certain formal irregularities, the pharmacy operator or doctor may be obliged to refund the reimbursement amount for the drug resulting from the "faulty" prescription. That is why the key importance for control is what (how valuable) prescriptions the National Health Fund examines. Sometimes the National Health Fund demands reimbursement from both parties in parallel.

Example:

The National Health Fund called on the pharmacy manager to submit 30 prescriptions from the previous 3 years for inspection. The total amount of drug reimbursements resulting from these prescriptions amounted to over PLN 1 million. As a result of the inspection, the National Health Fund found that most of the prescriptions had minor formal errors that did not affect patient safety or their correct implementation. Despite this, the National Health Fund, claiming that issuing the prescriptions violated the provisions of the Reimbursement Act, demanded a refund of the price of the drug and sent a payment request to the pharmacy. Due to the fact that only prescriptions with high reimbursement amounts were selected for inspection, the National Health Fund demands payment of the entire amount resulting from them, i.e. over PLN 1 million.

The situation described above is not uncommon. The National Health Fund apparently operates fully legally. However, by selecting prescriptions for the "control sample" according to such a scheme and applying very rigorous, detailed and often questionable control criteria from the point of view of statutory authorization, it is very easy and often to demand the return of very high amounts. In the above example, as in any other, the controlled pharmacist may (either independently or through a specialized Law Firm) defend yourself by submitting an appeal letter to the President of the National Health Fund, specifically "Reservations regarding the post-audit statement". However, most often, one way or another, justice must be sought by defending one's rights in court. Especially since our practice shows that most decisions are favorable for pharmacists and doctors. This is the case at least in cases where there was no intentional criminal act.

What to do when the National Health Fund wants a refund? How to write an appeal? About reservations regarding the National Health Fund's audit report.

The "appeal" itself, as stated above, takes the form of "Objections to the post-inspection statement" (hereinafter: Objections), which are legally empowered in Art. 61t of the Act of 27 August 2004 on health care services financed from public funds. However, this writing has character de facto is not particularly different from an ordinary appeal in administrative proceedings - after all, we indicate in it those actions of the National Health Fund that, in our opinion, were inconsistent with substantive or procedural regulations.

In this letter, we must state who is appealing, i.e. the pharmacist's details, describe which inspection it concerns (a characteristic inspection number/code is assigned each time and individually), and address it to the President of the National Health Fund through the local department of the National Health Fund that carried out the appeal. control.

As for the content of the Reservations itself, it is difficult to provide universal guidance because individual cases differ from each other and the basis for imposing a penalty or - which is crucial from the point of view of this article - demanding reimbursement of the price of the drug by the National Health Fund may vary. For example, according to our experience gained while handling this type of cases, the grounds may be as trivial and easy to "fight" as placing only a stamp (instead of a signature and a stamp) on the back of the prescription, or more serious, such as dispensing a medicine in the wrong quantity and package sizes and/or doses.

The appeal should briefly include the facts, and then thoroughly describe the legal arguments, cite judgments, etc. It should be remembered that this letter will be examined by a person who is dealing with a given case for the first time, so he or she must know the background of events and facts that led to the issuance of such a decision by the National Health Fund control body. As for the legal arguments themselves, one should rely primarily on the hierarchy of sources of law, relevant provisions, acts and the achievements of the judiciary (possibly also regulations and other acts) that relate directly to the case and which cite as the basis for its decisions in the post-audit statement. National Health Fund.

We already know from practice that incorrect preparation of Disclaimers may have disastrous consequences. Ineffective formulation of the argument, basing it on defective regulations or other shortcomings may result in the Objections not being taken into account and all decisions of the control body being upheld not only by the President of the National Health Fund, but also later by the Court.

Example

A client came to our office and prepared and submitted objections on his own, together with the pharmacy manager. The arguments they raised were not taken into account by the President of the National Health Fund, as in most such cases. However, the defense line prepared by the clients themselves, to put it mildly, did not provide much scope for defending the case in court.

The deadline for submitting Objections is also important. It should be determined on the basis of Art. 61t. paragraph 1 of the Act on health care services financed from public funds. It mentions the obligation to pay within 14 days from the date of delivery of the Post-Inspection Statement to the pharmacy manager. Therefore, an appeal (Objections) must be submitted within this deadline, after all, in accordance with section 2 of the said regulation, the President of the National Health Fund will refuse to accept Objections if they were submitted by an unauthorized person or after the expiry of the 14-day period.

Meeting this deadline is absolutely crucial, as our practice shows that sometimes we are able to effectively appeal against the inspection result and protect the client from the obligation to pay already at the stage of disputing the claim. However, when this client comes to us, e.g. a month after the date of delivery of the Instance, when he received a declaration of deduction from the National Health Fund - our room for maneuver is slightly more limited and the case is unnecessarily escalated. In such a situation, we are forced to seek justice for the client only in court.

The fact that it may be possible to recover these funds in court will not compensate for the stress and problems caused by the deduction of these funds by the National Health Fund.

To sum up this part, it should be noted that it is crucial for the punished pharmacist to ensure that the deadline for submitting objections does not expire. As for the formulation of the content of the Objections itself, we recommend seeking advice from a lawyer specifically experienced in such proceedings. Preparing such a complicated letter on your own usually has disastrous consequences.

National Health Fund inspection of the pharmacy: example from practice - no signature on the prescription

In one of the above paragraphs, one of many situations was mentioned in which the basis for "punishing" a pharmacist was to place only a stamp instead of the pharmacist's stamp and signature on the back of the prescription. On this basis, the National Health Fund - not finding any other deficiencies and emphasizing that there were no other objections to prescriptions for reimbursed drugs - demanded a five-digit amount from our client. Therefore, it is not an amount that can be spent lightly from one day to the next.

The client happily contacted us immediately after receiving the Post-Inspection Statement from the National Health Fund. He also did not take any action on his own. Therefore, we avoided a large part of the mistakes that resulted in loss of money for some of our clients.

The Supreme Court and other courts often point out in their judgments that when analyzing this type of cases, one should primarily take into account the objectives that underlie the provisions on reimbursement and prescription filling, i.e., on the one hand, tightening the drug reimbursement system and ensuring control over the funds. public, and on the other hand, helping patients and protecting their well-being, e.g. against filling an incorrectly issued or filled prescription. In short, the Supreme Court clearly indicates that the purpose of regulations establishing requirements is to protect legally protected goods, such as the well-being, health and life of patients, and the efficient operation (tightening) of the drug reimbursement system. Penalties and other sanctions should therefore be imposed only if the pharmacist's actions expose these legal rights to damage or violate them. The lack of a signature - with the simultaneous affixing of an identifying stamp - does not meet the above requirements. It may indeed constitute a certain formal violation, but in this situation it does not violate legally protected goods.

The signature is only a technical step that completes the drug dispensing process and if there are no objections to it, the pharmacist cannot be punished for failing to perform this step. Therefore, using legal nomenclature, it can be stated, following the Court of Appeal from Szczecin, that: "functional interpretation in its teleological aspect of Art. 43 section 1 point 6 of the Act of 12 May 2011 on the reimbursement of medicines, foodstuffs for special purposes and medical devices requires the assumption that not every identified failure to fulfill a prescription imposes an obligation on the entity running the pharmacy to refund the amount corresponding to the refund of the price, unless it leads to use of the refund amount by an unauthorized person and does not violate the patient's safety. This is a fragment of quite accurate argumentation derived from case law that we raised in that case.

Summary:


A) doctors and pharmacists need professional legal support during disputes with the National Health Fund
B) the sooner they apply for it, the greater the chance that the case will be won
C) higher court rulings tend to side with doctors and pharmacists
D) unfortunately, initial appeals do not always bring results, although their content is extremely important in the further course of the case.

Our experience clearly shows that the negative effects of National Health Fund inspections are most often thousands of requests for refunds. They have already brought down more than one business. However, subsequent rulings issued by courts in cases we conduct or observe clearly show that efficient handling of the case with an experienced lawyer significantly increases the chances of avoiding the obligation to pay.

LEGAL COUNSEL PIOTR KŁODZIŃSKI TOGETHER WITH JUNIOR ASSOCIATE - KRZYSZTOF BARDEL

Our PHARMACEUTICAL LAW OFFICE helps doctors and pharmacists in conflict situations, disputes with the National Health Fund, preparation of appeals, we also provide representation services in control and disciplinary proceedings. 
We also invite those interested to read it the second of our articles on disputes between pharmacies and the National Health Fund regarding refunds.

PS It is always worth contacting a lawyer as early as possible. Typically, the sooner you seek professional help, the more you can save.

PS2 In recent months, the National Health Fund's activities aimed at obtaining refunds for incorrectly issued prescriptions for NEOCATE LCP and NEOCATE Junior have been particularly intensified. In such cases, we cordially invite not only injured doctors, but also the lawyers representing them, to contact us - because we are preparing a broad information campaign and protests on this matter. 

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