L’Ats Bergamo asked a general practitioner for a refund of 332,992 euros to the national health service for a off-label drugthat is, off-label, prescribed to a patient for two years (2018 and 2019). It is a painkiller indicated for pathologies other than the one suffered by this young man, who has tried other therapies and wandered from hospital to specialist, but it seems to have been the only one to relieve his pain. There are many rules, as well as exceptions.
The doctor asked the TAR for a stay, which rejected it because the ATS Bergamo will only be able to collect the money after a (possible) conviction of the Court of Auditors. “I wish I had a doctor who was so attentive to the patient.” Lawyer Yvonne Messi is her lawyer in a battle with the ATS before the TAR that, logically, will end up in the Court of Auditors.
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This general practitioner received a request for reimbursement from the National Health Service for “prescribing inappropriateness”. And here we enter a thicket of rules and exceptions, which originated in 1998 with the Di Bella’s Lawwhich 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 any benefits, he visits hospitals and centers even outside of Lombardy, even a neurosurgeon who excludes the possibility of surgery. Until 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 dated December 20, 2023, the general director of ATS Bergamo signs the note with the request for reimbursement to the doctor.
She appeals to the Regional Administrative Court (TAR), asking for 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’ motivation is that, for now, the request for compensation is not stringent. This can be read in the note from the ATS DG, who anticipates: “In the event that you do 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 exercise the administrative liability action provided for by current legislation”.
“Off-label drugs are not covered by the national health system, their use is considered experimental,” he explains. Mirko Tassinariformer provincial secretary of the Federation of general practitioners, who however specifies that he “does not know the specific case of his colleague”.
Others are the notes of theAIFA “which establish the limits for the prescriptions”. For example, the Toradolwhich can be prescribed by injection for kidney stones and for post-surgery. In drops, it is registered only for the second use, “otherwise it is off-label and requires the patient’s informed consent.” 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 reevaluate whether the patients to whom we had prescribed it fell within the new parameters.”
Nurse Times Editorial Team
Source: Corriere della Sera
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