Medical self-government about the reimbursement law: it does not implement an important demand of the environment

Below we publish the content of the July 5 and July 7 posts:

POSITION No. 40/23/P-IX

PRESIDIUM OF THE SUPREME MEDICAL COUNCIL

dated July 5, 2023.

on the draft law amending the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices and some other laws

The Presidium of the Supreme Medical Council, having familiarized itself with the draft law amending the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices, as well as some other laws (parliamentary print 3408), makes the following comments on the draft in question:

The proposed law does not implement - agreed with the Minister of Health - the medical community's demand to remove from doctors the obligation to mark the level of reimbursement of a drug when issuing a prescription. It should be recalled that in § 16 of the agreement concluded on February 8, 2018 with the OZZL Residents' Agreement, the Minister of Health undertook to submit draft legislation removing the need for doctors to mark the level of drug reimbursement on the prescription. These changes were to come into effect no later than the end of 2019. Despite these assurances, to date doctors are still obliged to mark the level of reimbursement on the prescription and, as you know, are also held financially responsible for doing so. In order to abolish the obligation to mark the level of gratuity on the prescription, the Presidium of the Supreme Medical Council proposes the adoption of amendments to the law as in the attachment to the position.

The medical association also raises objections to the proposed wording of Article 96a (2-3) of the Pharmaceutical Law. They assume a reduction from the current 360 days to 180 days of the maximum period for which a doctor will be able to prescribe for a patient a single quantity of a medicinal product, foodstuff for special nutritional use or medical device. The bill also provides for a reduction in the amount of drugs that can go on a single prescription - on a single prescription, the amount of a medicinal product, foodstuff for special nutritional use or medical device will not be allowed to exceed the amount necessary for a 60-day period of use. These changes will adversely affect long-term patients, resulting in the need to increase the frequency of visits to the doctor and pharmacy, which will particularly affect patients with limited mobility or the elderly. The changes will result in reimbursable drugs not being produced in larger packages, allowing therapy for longer than 60 days.

Objections are raised by the proposed change within Article 14 of the Reimbursement Act to delete paragraph 1(2)(b). Pursuant to this provision, the Minister of Health, when issuing a reimbursement decision, shall qualify for a lump sum payment a drug, a foodstuff for special nutritional use, a medical device qualified under Article 72 or its equivalent. The provision allows the Minister of Health to qualify for lump-sum payment not only drugs that meet the current cost criteria, but also those that were available on a lump-sum basis before the Reimbursement Law entered into force, as well as their equivalents (under Article 72 UR). The absence of this provision could result in the reclassification of popular drugs to the 30% payment category.

Appendix:

Suggestions for amendments

to the Law on Amendments to the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices and Some Other Laws (parliamentary print 3408)

Amendment 1:

In Article 1, item 50 of the Law - in the proposed Article 48, paragraph 7a of the Law of May 12, 2011 on reimbursement of drugs, foodstuffs for special nutritional purposes and medical devices, item 4 is repealed.

Justification:

This provision imposes an obligation to reimburse the Fund an amount equivalent to the amount of the refund if a prescription is written that does not comply with the indications contained in the notices referred to in Article 37 (1) or (4).

Amendment 2:

In Article 2 of the Law (concerning amendments to the Law of September 6, 2001, Pharmaceutical Law), another point is added after point 11, which reads:

"12) In Article 96: in paragraph 3a, point 9 shall be repealed."

Justification:

With regard to prescriptions issued by a pharmacist for the continuation of therapy with a medicinal product, the provision requires that the prescription content indicate the gratuity previously specified by the doctor on the continued prescription, unless the pharmacist issuing the prescription became aware of the need to change the gratuity. Since the doctor will not indicate the level of payment, it is also not required to indicate the level of payment in the case of a continuation prescription.

Amendment 3:

In Article 2 of the Law (concerning amendments to the Law of September 6, 2001, Pharmaceutical Law), item 12 (amendments to Article 96a of the Pharmaceutical Law) is amended as follows:

The amendment marked a is repealed

Subparagraph g is added, reading:

in paragraph 8, points 7-9 are deleted

Justification:

The repeal of Article 2, point 12(a) of the law will mean that the current rules for long-term prescriptions - up to 360 days - will remain in Article 96a of the Pharmaceutical Law.

The addition of the letter g in Article 2, point 12, will mean that Article 96a of the Pharmaceutical Law, which specifies the content of a prescription on which at least one of the prescribed medicinal products, foodstuffs for special nutritional purposes, medical devices is covered by reimbursement, will no longer require the indication of the level of payment.

Amendment 4

The following Article 6 is added after Article 5 of the Law:

"Article 6. In Article 45 of the Act of December 5, 1996 on the professions of physician and dentist (Journal of Laws of 2022, item 1731), paragraphs 2a-2c shall be repealed.".

Justification:

Article 45 (2a-2c) imposes an obligation on the physician to mark the level of payment when issuing prescriptions for drugs, foodstuffs for special nutritional purposes, medical devices specified in the lists referred to in Article 37 of the Law of May 12, 2011 on reimbursement of drugs, foodstuffs for special nutritional purposes and medical devices.

Amendment 5

After Article 6, the following Article 7 is added:

"Article 7. In Article 15a of the Act of July 15, 2011 on the professions of nurse and midwife (Journal of Laws of 2022, item 2702), paragraphs 4, 4a and 4b shall be repealed."

Justification:

Article 15a imposes an obligation on nurses to mark the level of payment when prescribing drugs, foodstuffs for special nutritional purposes, and medical devices specified in the lists referred to in Article 37 of the Law of May 12, 2011 on the reimbursement of drugs, foodstuffs for special nutritional purposes, and medical devices.

POSITION No. 41/23/P-IX

PRESIDIUM OF THE SUPREME MEDICAL COUNCIL

dated July 7, 2023.

on the draft law amending the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices and some other laws

The Presidium of the Supreme Medical Council, having completed the first reading in the Sejm of the Republic of Poland of the bill amending the Act on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices and Certain Other Acts (Sejm print 3408), upholds the comments submitted to the bill and additionally submits a proposal to regulate in Article 95b of the Pharmaceutical Law the rules for issuing prescriptions in electronic form. It is unreasonable to treat teleprescribing as a method that allows prescriptions to be issued without regard to the standards of due diligence in patient care. The issuance of a prescription, following an examination in the form of a teleportation, should always be determined by medical considerations, and not solely by expectations supported by payment of a fee for the service.

The Bureau proposes the introduction of a rule that prescriptions in electronic form may be issued either after examining the patient in person, or after examining the patient via data communications systems or communications systems that provide simultaneous transmission of audio or video taking place in real time. Exceptions to this rule will apply to prescriptions issued by doctors and nurses in conditions of continuing treatment, if this is justified by the patient's condition reflected in the medical records to which the person issuing the electronic prescription has access.

The Presidium of the Supreme Medical Council proposes to adopt the amendments to the law as in the annex to the position.

Appendix

To Position No. 41/23/IX-P

Presidium of the NRL dated 07.07.2023.

AMEND

In Article 2 of the law (concerning amendments to the Pharmaceutical Law), the following point 11a is added after point 11:

In Article 95b of the Act of September 6, 2001. Pharmaceutical Law, the following paragraph 3a is added:

3a. The issuance of a prescription to a patient in electronic form may take place on condition that the person authorized to issue a prescription has first performed a personal examination of the patient to whom the prescription is to be issued, or has examined the patient by means of information and communication systems or communication systems providing simultaneous transmission of audio or video taking place in real time, except when:

the prescription is issued under the circumstances referred to in Article 42(2) of the Act of December 5, 1996 on the professions of physician and dentist (Journal of Laws of 2022, item 1731, as amended) and Article 15b(2) of the Act of July 15, 2011 on the professions of nurse and midwife (Journal of Laws of 2022, item 2702, as amended),

no more than six months have elapsed since the last personal examination of the patient by a person authorized to issue a prescription, and this is reflected in the medical records to which the prescriber has access before issuing the prescription."

Justification:

Teleportation is an important and necessary tool for administering medical care to patients. In the post-pandemic period, it is difficult to overestimate the role it has played. However, teleportation should be identified as a form of providing health care services at a distance using ICT or communication systems. It should provide the patient with the same level of care and the appropriate quality of services provided. The rules for providing advice using telemedicine technologies and in-person advice should be, in principle, the same. Telecounseling is a recognized way of providing patient care, provided, however, that the conditions for providing medical care in this mode meet the standard of due diligence. One of the elements of advice given to a patient in this mode may be the issuance of a prescription or certificate, including a certificate of temporary incapacity due to illness.

However, it is unreasonable to treat teleprescribing as a method that allows commercial online prescribing with a disregard for due diligence standards in patient care.

Thus, it is proposed to introduce a rule that prescriptions in electronic form may be issued either after examining the patient in person, or after examining the patient via teleinformation systems or communication systems that provide simultaneous transmission of audio or video taking place in real time. Exceptions to this rule will apply to prescriptions issued by doctors and nurses in conditions of continuing treatment, if this is justified by the patient's health condition reflected in the medical records to which the person issuing the electronic prescription has access.