Rare Disesases: The 2019 and co-pay fee exemptions

The good news is another group of diseases that are eligible for exemptions have recently been added to the list of rare diseases (diseases that affect no more than 5 people in 10,000). For patients, this often means medical examinations and check-ups to diagnose and manage the disease without increased expenses. Given the particular nature and greater cost of treatments for these diseases, exemptions are fundamental.

Unfortunately, however, the health care system continues to face some challenges, such as the lack of central coordination and, even worse, the absence of a National Plan for Rare Diseases for two years now, all this in a sector that has also lost nearly 100 million Euros per year due to the revised co-pay system for medicine in the budget law.

List of rare diseases

There are currently 7,000-8,000 different diseases categorized as rare, of which 80% are genetic. Since mid-April, an updated list is available with very clear and detailed illustrations of nearly 1,000 diseases.  OMAR (Observatory for Rare Diseases), in collaboration with Orphanet-Italia, updated the new 2019 exemption guide (last revised in 2017). The result is a practical and simple instrument for patients, local health authorities and, more generally, for anyone operating in the health sector. The objective is to simplify the understanding of changes in levels of care (LEA) through a list of new codes, a complete list in alphabetical order of all diseases that qualify for exemption and detailed instructions on how to obtain the exemption. The guide also offers instructions on how to obtain other economic and non-economic benefits,  that patients with rare diseases may be entitled to in accordance to the laws in force.

Exemptions for patients

Guaranteeing the recognition of a rare disease and adequate protection of people affected by rare diseases is the objective of our health system.  For this reason, various provisions have been taken and the following services are exempt from co-pays (“tickets”):

  • All applicable and effective services to treat and monitor a known rare disease and to prevent further deterioration.
  • Diagnostic services carried out by National Healthcare Centers to confirm a suspected diagnosis formulated by aNational Health Service
  • Genetic exams for family members of a patient, which may be necessary to diagnose a patient with a rare genetic disease. 80% of rare diseases are of genetic origin, which can only be established through exams (often very expensive), performed also on the patient’s family members.

For more information, in addition to the national toll-free number of the National Institute of Health (800.896949), available Monday to Friday from 9am to 1pm, an information system specifically for Patients and Caregivers has been activated in 18 regions with 14 telephone helplines. This service, however, has a different level of effectiveness in each region.

National Plan for Rare Diseases

The last Italian National Plan for Rare Diseases expired in 2016, showed a lack of financing and did not even come close to being implemented. All the same, some progress has been made due to pressure put on by patient associations, which requested a minimum amount of consideration and recognition, and the constant efforts made by OMAR. On June 20, 2019, the Directorate General of Health Planning from the Ministry of Health established a work group to update the National Plan. The work group includes the Minister, the Regions of Italy, the Italian National Agency for Regional Healthcare Services (AGENAS), the National Institute of Health (ISS), the Italian Medicines Agency (AIFA), UniamoItalian Non-profit Organization, European Medicine’s Agency (EMA) and Bambino Gesù Children’s Hospital.

The errors of the past should now be used to create an effective National Plan that demonstrates the government remains close to its patients. OMAR emphasizes that the Plan must not only be supported by adequate financing, but also by modern infrastructures and professionals that are trained in new technologies and know how to relate to patients. This is a fundamental testing ground. If successful, it will not only constitute a positive example of good healthcare, but could become the model for future healthcare projects.

© Domedica s.r.l.

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