In July, the General Health Insurance Company of the Czech Republic (VZP), the major Czech payor, published updated guidelines for enlisting hospital medical devices in VZP’s product list. In this respect, Jiří Štěrba, Director of the Medical Devices Department of VZP, told Zdravotnický deník that VZP's vision is to introduce other elements of healthcare technology assessment (HTA), as currently only the budget impact analysis is used.
On the one hand, VZP’s efforts to establish certain rules for the entry of hospital medical devices into the reimbursement system make it easier to foresee VZP’s actions. On the other hand, however, it should be noted that the Public Health Insurance Act does not provide for any specific rules for enlisting hospital medical devices in payors’ product lists – when it comes to hospital medical devices, reimbursement regulation is completely absent in the law. Therefore, VZP determines the content of its guidelines at its own discretion without any support in the law.
The Constitutional Court held in 2017 that the reimbursement regulation relying on payors’ product lists is not constitutionally compliant. It literally held that "the identified deficiencies, by their nature, burden the existing statutory regulation of the system of reimbursement of medical devices from public health insurance as a whole, regardless of whether the subject matter of such regulation are medical devices provided in inpatient or outpatient health care" (Constitutional Court judgment No. Pl. ÚS 3/15 of 30 May 2017, par. 150).
Following the Constitutional Court judgment, we have seen a new reimbursement regulation for medical devices prescribed based on a voucher. However, reimbursement regulation for hospital medical devices is still absent.
The EU HTA Regulation (Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) foresees that EU-wide HTA should also be carried out for medical devices. Will this serve as an incentive to introduce modern, transparent and predictable reimbursement regulation for hospital medical devices in the Czech Republic?
