The Rules for ensuring the provision of medical care (if necessary outside the Russian Federation) to a specific child with a serious life-threatening or chronic disease, including a rare (orphan) disease, or to groups of such children (hereinafter – the “Rules”) were approved by Decree of the Government of Russia dated May 21, 2021 No. 769.
The Rules apply to children under 18 who are citizens of the Russian Federation.
In order to organize financial support for the provision of medical care to children with serious diseases, the Circle of Kindness Foundation must approve a list of severe life-threatening and chronic diseases, including rare (orphan) diseases, and a list of categories of children with these diseases. The list of diseases is formed based on the following criteria:
- prevalence of the disease is no more than 10 cases per 100 thousand of the population and (or) if the disease is chronic with a severe course, leading, without pathogenetic treatment, to severe disorders of vital functions or death in childhood;
- for the treatment of the disease, in addition to the volume of medical care provided to citizens within the framework of the compulsory medical insurance program, additional financial support is required for the provision of medical care to children with orphan diseases, including the provision of medicines and medical devices, as well as technical means of rehabilitation;
- for the treatment of the disease, there are medicinal preparations of pathogenetic action or there are medical devices intended for the correction or treatment of life-threatening diseases, registered in the Russian Federation and (or) in the countries of the European Union, and (or) in the United States of America, as well as technical means of rehabilitation ;
- there is a scientifically proven treatment method to treat the disease.
The specified list is subject to revision at least once every 2 years.
The list of categories of children is formed taking into account such criteria as:
- presence of features of the course of the disease, in which an unfavorable outcome may occur without the use of drugs, medical devices and technical means of rehabilitation;
- absence of specific features of the disease or condition in which, for technical and other reasons, it is impossible to use drugs, medical devices and technical means of rehabilitation intended for the treatment of diseases included in the list of diseases.
These lists are formed on the basis of proposals sent to the Fund by the chief freelance specialists of the Ministry of Health, executive authorities of the constituent entities of the Russian Federation in the field of health protection, as well as public associations for the protection of citizens’ rights in the field of health protection, charitable organizations, and legal representatives of children.
The provision of medical care to a specific child with an orphan disease is carried out if it is necessary to use new complex and (or) unique treatment methods for the child’s treatment, as well as resource-intensive treatment methods with scientifically proven effectiveness, including the use of cellular technologies, robotic technology, information technologies and methods of genetic engineering, developed on the basis of the achievements of medical science and related branches of science and technology, which are not included in the list of types of high-tech medical care contained in the program of state guarantees of free provision of medical care to citizens.
Additional financial support for measures related to the provision of medical care to a specific child with an orphan disease is carried out at the expense of grants provided to the Fund from the federal budget in the form of subsidies, as well as other sources stipulated by law.
The provision of medical care to a specific child with an orphan disease is carried out by the decision of the Foundation’s expert council in the presence of a copy of the discharge summary from the hospital patient's medical record issued by the federal medical organization to which the child was sent, indicating information about the state of health and recommendations on the need to use for treatment a child with an orphan disease of a complex type of medical care.
It is noteworthy that this document allows a decision to be made to provide assistance to children outside of Russia in the absence of the possibility of providing such assistance in our country.
Financial support of activities related to the provision of medical care outside Russia to a specific child with an orphan disease is carried out at the expense of grants provided to the Fund from the federal budget in the form of subsidies, as well as other sources provided for by law, which are intended for:
- payments in foreign currency for services of foreign organizations related to the treatment of a specific child with an orphan disease;
- payments in rubles to Russian citizens sent for treatment outside the territory of Russia and their accompanying persons (legal representatives and (or), if medically indicated, to medical workers;
- funds for the cost of renting a dwelling – in the amount established by regulatory legal acts on reimbursement of expenses related to business trips to the territory of foreign states of employees of federal state bodies, state extra-budgetary funds and federal state institutions;
- funds for travel expenses to the place of treatment and back, but not more than the cost of travel for the child and the person accompanying him: by air – in an economy class cabin, by rail – in a compartment carriage of a high-speed train; by water transport – in the cabin of the V group of a sea vessel of regular transport lines and lines with complex passenger services, in the cabin of the II category of a river vessel of all lines of communication, in a cabin of the I category of a ferry vessel; by road – in a public transport vehicle (except for taxis).
June 10, 2021