In May, the inter-departmental comment procedure concluded for a new act that would regulate reimbursement of prescription medical devices, such as incontinence pads, prostheses, hearing aids, and glucometers, as well as dental products covered under public health insurance. The proposals include transferring part of the reimbursement regulation to a separate law, as well as substantive changes, for example the amount and conditions for reimbursement of medical devices for diabetics.
The new act seeks to remove provisions regarding the amount and conditions for reimbursement of prescription medical devices (the ‘categorization tree’) and dental products from the Public Health Insurance Act.
‘Parametric change’
According to the explanatory memorandum, the act constitutes a ‘parametric change’. It is intended to provide greater flexibility and the ability to reflect the needs of the society in an efficient and timely manner by making changes to reimbursements easier.
However, the act has also met with criticism. For example, as explained by the Minister for Legislation and the Chairman of the Legislative Council, the act does not actually remove the legislation concerned from the Public Health Insurance Act. Instead, the act refers to and implements it. According to the Minister, materially, this is an implementing regulation to the Public Health Insurance Act. For this reason, the Minister considers it appropriate to withdraw the act entirely.
It is clear that the main reason for creating a new law should not be the impracticality and length of the process that is required to regularly update the categorisation tree by amending existing legislation.
According to the current wording of the act, the changes are to take effect as early as 1 January 2025. In view of the above and the current status of the legislative process (the proposal has not yet been discussed by the government) the intended effective date remains uncertain.
Are hospital medical devices still a neglected part of the reimbursement regulation?
Please note that the act does not apply to ‘separately charged materials’, such as implants, pacemakers, valves, cannulas, catheters, probes, staplers, laparoscopic devices, and stents. The amount of reimbursement for these medical devices remains subject to reimbursement catalogues created by health insurance companies – something that the Constitutional Court found to be unconstitutional in the case of prescription medical devices.
The Constitutional Court ruled that ‘reimbursement catalogue’ regulation was also problematic for hospital medical devices. It stated that “the identified deficiencies inherently burden the current statutory regulations governing the reimbursement system for medical devices covered by public health insurance, regardless of whether the devices are used for inpatient or outpatient care”.[1]
It is therefore clear that the reimbursement of separately charged materials would also deserve the attention of the legislature. Health insurance companies lack clear legal regulations governing their procedures for including separately charged materials in the reimbursement catalogues, which often creates difficulties for producers. The absence of clear procedural guidelines gives insurance companies significant discretion, making it difficult to predict their decision-making processes.
This serious legislative failure remains unresolved, with no indication that the Ministry of Health is taking any action to address it.
