Medical devices on prescription: From January 1, 2024, big changes for patients

The proposed amendment aims to expand patient access to medical devices on prescription, taking into account both new items and adjusting limits to market realities. The proposed amendment introduces changes in response to the demands of patients, doctors and patient organizations. The aim of these proposals is to increase the availability of medical devices and to make the current regulations more specific, thereby eliminating interpretation problems.

The new wording for Paragraph 2(2) of the regulation is intended to organize the regulations regarding the authority of physicians during and after specialization to issue orders for medical devices.

The annex to the regulation, due to the size and scope of the changes, as well as the need to take into account the possibility of introducing new products within certain categories, received a completely new shape and numbering, according to codes rather than ordinal numbers.

Of the substantive changes, the most important issues include:

1. Changes to the limits and descriptions of custom orthoses and prostheses, as well as custom orthopedic footwear, as a result of technological changes, as well as the need to take into account the prices of medical devices. Limits were determined based on market data, as well as the possibility of obtaining subsidies from the State Fund for Rehabilitation of Persons with Disabilities, which, in the case of persons with disabilities, is the source of subsidies for medical devices reimbursed by the National Health Fund, hereinafter referred to as the "NFZ."
2. Reducing the patient's share of the reimbursement limit for absorbent devices from 30% to 20% and 10% for children, which should significantly reduce the burden on the patient's side of the supply of absorbent devices. The prices of medical devices under prescription medical devices are not rigid, allowing the search for devices at the most competitive prices for the patient. Given the available supply pathways, including the possibility of mail-order purchases over the Internet by providers who have signed a contract with the National Health Service, lowering the share of the cap increases the affordability of absorbent devices.
3. Introducing INR/PT measurement devices for patients treated with vitamin K antagonists, requiring regular monitoring of the PT/INR ratio until the age of 18, or with artificial mechanical heart valves or atrial fibrillation with moderate to severe mitral stenosis, or who have a certificate of severe disability, with the aim of improving adherence to pharmacotherapy and facilitating treatment monitoring, as well as changes in drug dosage in medically justified cases.
4. Addition of custom orthotic insoles along with a study of pressure distribution on the sole side of the feet to serve the prevention of primary or secondary ulceration in patients with diabetes and diabetic foot syndrome.
5. Expanding the list to include circular compression devices in the venous insufficiency patient population for the treatment or prevention of venous ulcers.
6. Changes in the reimbursement of insulin pump accessories, taking into account the recommended useful life, as well as new products on the market.
7. Increasing the reimbursement limit for very high vision defects over 10 dptr.
8. Division of white cane reimbursement by functionality and application, with separate limits.
9. Introducing reimbursement for products dedicated to post-mastectomy patients: prophylactic circular compression sleeves, post-operative corsets and bras.
10. Breakdown of breast prosthesis reimbursement by design and increase in limit for wigs.
11. The inclusion of rare diseases such as hyperinsulinism and glycogenosis in the reimbursement of glycemic monitoring systems, as well as changes in the conditions for granting these systems (including expanding the indications for FGM reimbursement to include pregnant and postpartum women with diabetes).
12. Reduce the share of hydrophilic catheters in the limit to 10% for adult patients.
13. Introducing refunds for HME filter attachment patches.

Due to the scope of the changes, the amendment should go into effect on January 1, 2024, which will allow the NFZ's IT systems to adapt.

Source: RCL