On 8 October 2024, the Ministerial Decree No. 36/2024/ZDM establishing the Commission for the categorisation and reimbursement regulation of medical devices came into force. This advisory body of the Ministry of Health was already created in 2019 shortly after the launch of the reimbursement regulation for medical devices prescribed on voucher. This change was necessitated by a ruling of the Constitutional Court, which found the then regulation based on the institute of least costly implementation to be unconstitutional.
Since 2019, the entire agenda has been taken over by SIDC, with the basis of regulation becoming the categorisation tree contained in Annex 3 of the Public Health Insurance Act. On one side, the legal certainty of all parties concerned has been strengthened, but the flip side of the new system is its rigidity in the sense of a complicated process leading to updating the amount and conditions of reimbursement of medical devices. In order to enable the MoH to make informed decisions and to prepare the annual revision of the categorisation tree, the Commission for categorisation was created. Its members were representatives of all organisations concerned with the agenda. The Commission was initially based solely on a consensus procedure. However recently some controversial proposals have been subject to force votes, and it has become clear that the composition of the Commission, or the balance of votes, is not fair. While health insurers companies had only 4 votes in total, medical device suppliers and patient organisations had 9 votes. This led to unfortunate situations such as the approval of the reimbursement of glucose sensors for type 2 diabetics this year. The Commission for categorisation approved the proposal despite the fundamental opposition of health insurance companies, which then torpedoed the subsequent amendment to the law wherever they could.
The decree responds to the problems of the Commission's functioning and changes both its composition and the voting ratios. Thus, the Health and Social Care Trade Union, the Union of Employers' Associations, the Association of Manufacturers and Suppliers of Medical Devices, the National Council of Persons with Disabilities, the Coalition for Health, the Czech Medical Chamber and the Czech Pharmacy Chamber are losing their representation in the Commission. The position of the MoH itself and professional societies is strengthened, health insurance companies and SIDC remain, all the representatives of suppliers and the representatives of patients only have 2 votes.
Author: Jakub Král