Challenge in Regional Planning of Molecular Genetic Diagnosis in Oncology

Molecular genetics testing (MGT) is an integral part of oncological clinical practice at the stages of diagnosing the disease and choosing antitumor treatment. For a whole list of oncological diagnosis, today the prescription of drug treatment cannot be carried out without “molecular navigation” among the range of therapeutic options. Despite the high demand among the professional and patient communities, cancer-related molecular tests have long been available to patients only as commercial services. Molecular cancer diagnostics have been included in the Program of State Guarantees (PSG, the Program) since 2020 and have become part of the basic compulsory medical insurance program. Based on the Program, the Territorial Programs of State Guarantees (TPSG) are formed in the constituent entities of the Russian Federation, including the planning of average cost and volume standards for Cancer-related molecular tests. The Territorial Programs of State Guarantees, in turn, serve as the basis for the subsequent formation of tariff agreements in the regions, where MGT is usually represented in the form of separate tests with a certain tariff for the service. According to the PSG, the constituent entities of the Russian Federation are entitled to adjust the standards "taking into account the types and methods of research of human systems, organs and tissues, depending on the structure of the incidence of the population." These same factors are indicated in the methodological recommendations of the Ministry of Health of the Russian Federation as criteria for the formation of tariffs for MGT in tariff agreements. However, at the moment, it is not clear how the types and methods of MGT, as well as the structure of morbidity in the regions, are taken into account when setting volume and cost standards in the TPSG and tariffs in the tariff agreements for molecular genetic tests in the "oncology" profile. There have been no studies aimed at analyzing the volume and cost standards in the TPSG, as well as the tariffs in the tariff agreements of the regions of the Russian Federation for MGT. There is limited preliminary information about the significant heterogeneity of the spectrum of included MGT, as well as the established tariffs for identical MGT between the tariff agreement subjects of the Russian Federation. Researchers have reported that irrational planning of MGT in the "oncology" profile is widespread in the constituent entities of the Russian Federation, and consists of the insufficiency of the established tariffs and the limited list of available molecular services in a number of regions. Thus, a comprehensive analysis of the current TPSG and tariff agreements of the regions with a focus on molecular genetic tests in the "oncology" profile is necessary.