“I wish I had a doctor who cared so much about the patient.” Lawyer Yvonne Messi is her lawyer in a battle with Ats before the TAR which, logically, will end up in the Court of Auditors. This experienced doctor received a request for reimbursement from the national health service of 332,992.38 euros for “prescriptive inappropriateness”. It is the value of a painkiller prescribed to a patient for the years 2018 and 2019. A medicine «off-label», i.e. off-label, registered for pathologies other than that of the recipient.
And here we enter a tangle of rules and exceptions, originating in 1998 with the Di Bella law, which intersects with the relationship of trust between doctor and patient. This is a young man with intermittent but severe pain. He tries various therapies without receiving benefits, he visits hospitals and centers even outside Lombardy, even by a neurosurgeon who excludes the possibility of surgery. As long as the specialist suggests (in writing) that drug. The doctor prescribes it and apparently the pain subsides.
But on January 27, 2024, based on the minutes of the Company Commission for Pharmaceutical Appropriateness (Caaf) of Ats of December 20, 2023, the general director of Ats signs the note requesting reimbursement from the doctor. You appeal to the Regional Administrative Court (Tar) requesting the suspension of the two documents. The TAR rejects the request and at first it is good news for the doctor, but the prospect is that the story does not end here. The judges’ reasoning is that, for now, the request for compensation is not stringent. We read it in the note from the general manager of Ats, who anticipates: «In the event that the company does not spontaneously provide compensation for the damage, the fact will be reported to the competent Prosecutor’s Office at the regional jurisdictional section of the Court of Auditors, so that it can take action. of administrative responsibility provided for by current legislation”. The Accounting Prosecutor’s Office could ask for the doctor to be ordered to pay, but also for her to be dismissed. Nobody forcibly cashes out, for now. This is what the TAR writes, citing the ATS procedure: «Only if the Prosecutor’s Office (accounting, ed.) decides to carry out the administrative liability action, and the relevant judgment ends with a conviction of the doctor, Ats will proceed with the collection of the sums”.
At present there are no new steps of which the doctor has been informed. It was not possible to know the details, from what the drug in question is to what the patient’s case history is. No explanation from Ats “as practice in the case of ongoing proceedings”. That the scenario is not simple can also be understood from the 19 pages of the Ats “company procedure on the control and promotion of prescriptive appropriateness”. Every six months any abnormal situations are reported and the doctor is invited to explain. The evaluation team can archive the case or send it to the CAAF, which in turn archives or requests reimbursement.
The starting point is simple, as the president of the Medical Association Guido Marinoni explains: «Generally speaking, the therapeutic indications of drugs are defined in the technical data sheet». But the law allows the use of some medicines for uses other than those for which they were authorized, under certain conditions. Who pays? Nodes also arise because research evolves, fortunately, but then clashes with other dynamics. «Some drugs have new indications which however are not recorded on the technical data sheet – again Marinoni -, because to do so it would be necessary to present expensive studies to the Italian Medicines Agency (Aifa, ed) or to the European Medicines Agency. Some are included in the dispensable lists, but only by hospitals”. «Off-label drugs are not paid for by the national health system, their use is considered experimental», Mirko Tassinari, former provincial secretary of the Federation of general practitioners, talks about it, specifying that «he does not know the specific case of his colleague ».
The AIFA notes “which establish the limits for the prescriptions” are different. For example, Toradol, which can be prescribed via injection for kidney stones and post-operations, is registered in drops only for second use, “otherwise it is off-label and the patient’s informed consent is required.” Here too, everything evolves. Tassinari remembers it well with vitamin D: «The notes were published in the Official Journal on Saturday to come into force on Monday. It was necessary to re-evaluate whether the patients to whom we had prescribed it fell within the new parameters.”
