Medical Devices and the Amendment to the Reimbursement Act

HTA Real World Data

V HTA Symposium in Krakow – Session Recap IV

Arcana Institute hosted the V HTA Symposium in Krakow on 29th-30th May 2017, which provided an in-depth view of the many important topics taking place in Poland in the realm of systematic changes in healthcare related to the development of clinical registries and planned introduction of amendments to reimbursement regulation concerning rare diseases and medical devices.

Medical Devices and the Amendment to the Reimbursement Act

Speaker’s Panel: Adam Sobantka, Poseł Lidia Gądek,  Mec. Ewa Warmińska, Mec. Wojciech Szefke, Mec. Bartosz Świdrak, Jarosław Stelmachowski

Moderator: Jacek Walczak

The proposed revision to the Reimbursement Act encompasses medical devices prescribed by a physician and those used within guaranteed benefits. The purpose of the amendment to the Reimbursement Act in relation to medical devices is to streamline the market, reduce the costs of the payer and the patient, increase access for patients, enable patients to make choices and to ensure competitiveness. The new system will successively indicate, by way of regulation of the MoH, medical device groups covered by a reimbursement decision. The allocation of medical devices will take into account the availability of guaranteed benefits, price competitiveness and costs to the payer and beneficiaries.

The amendment introduces a system of reimbursement for medical devices that is similar to that of medicines and requires the establishment of limit groups based on the following criteria:

  • Same indications or intended uses which are reimbursed
  • A similar mechanism of action (if applicable)
  • Similar effectiveness
  • Similar characteristics or technical parameters (if applicable)
  • Quality standards (if specified)
  • Cost-benefit ratio (if possible to determine)

In theory, the draft changes will provide patients with access to higher quality medical devices, made possible by applying co-payments, and will regulate the level of official margins. For medical devices prescribed by a physician, there will be 4 possible co-payment  levels for medical devices falling under a reimbursement decision: no charge, 10%, 30%, 50%. Medical devices that are covered under the guaranteed benefits will be eligible to be free of charge up to the limit of funding.

The biggest challenge is to properly define groups for medical devices, a task that falls within the competence of the MoH, with regard to the recommendation of the President of AHTAPol. For such a task, the Minister of Health may request the opinion of consultants, scientific societies, associations or foundations. The Minister of Health will, by way of regulation, define a list of medical devices along with information on the minimum quality standards for a given group as well as which HTA analyses should appertain to an application for reimbursement.

The procedure for issuing the reimbursement decision also considers the opinion of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) on the quality of the medical device. An application for an opinion on the quality of a medical device is subject to a fee of up to PLN 6,000. In the absence of sufficient resources, the President of URPL may request a research institute, university, certification body of medical devices or accredited laboratory to conduct an assessment of the medical device. The current provisions of the law do not specify the scope of activities that the URPL should take in the case that a medical device is found ineffective and how such an assessment will affect the manufacturer.

Apart from the planned changes in the reimbursement of medical devices, attention was also placed on characteristics of devices related to diversity, variety of models, solutions and configurations, as well as related issues such as:

  • Necessity to submit a separate application for each type, model, designation and size of the medical device,
  • Minimum quality standards to be met, as set by the President of URPL
    • Fee to submit application to receive an opinion (up to 6,000 PLN)
    • The obligation to make a medical device available to patients
  • Issue of analogous device that is not evident (from a “medical device having the same intended use and characteristics”)
  • Excessive burden on the state apparatus,
  • Unprofitable/not economical for business entities

Furthermore, the general statutory provisions were highlighted during the discussion, for which regulations can be prepared restricting and / or changing the proposed ‘good intentions’ the of the law, which include patient access to higher quality medical devices with possible co-payments and regulation of the level of official margins.

The panel also discussed the need for preparing an HTA for hospitals as a tool to support rational decision-making at the local level in situations of limited financial resources. In addition, HTA at the hospital-level may be used to define qualitative criteria for tenders, taking into account cost-effectiveness from the perspective of the hospital and for the optimization of granting benefits.

Nowelizacja ustawy refundacyjnej a wyroby medyczne

Medical Devices and the Amendment to the Reimbursement Act