Organization and payment for molecular genetic analysis in patients with certain malignancies in the constituent entities of the Russian Federation

Objective. To analyze the system of organization and payment for molecular genetic testing used for diagnosis of six most common malignancies in certain constituent entities of the Russian Federation and to improve its effectiveness. Material and methods. We prepared a list of molecular genetic tests specified in current versions of clinical guidelines for six most common malignancies: cancer of bronchi and lungs (C34), breast cancer (C50), ovarian cancer (C56), prostate cancer (C61), pancreatic cancer (C25), and chronic lymphocytic leukemia (C91.1). Information on scheduled volumes of molecular genetic testing and tariffs was extracted from territorial programs of state guarantees for free care to citizens for 2023-2025, as well as from tariff agreements in compulsory medical insurance system in 8 constituent entities of the Russian Federation (Moscow, Moscow Region, St. Petersburg, Sverdlovsk Region, Novosibirsk Region, Primorsky Krai, Khabarovsk Krai, Amur Region). We surveyed 8 experts from constituent entities of the Russian Federation (managers, heads or employees of diagnostic laboratories, pathology departments) regarding availability of molecular genetic tests for patients with certain malignancies, organization, payment for them and proposals for its improvement. Results. In 8 constituent entities of the Russian Federation, various outpatient molecular genetic tests are performed at the expense of compulsory medical insurance funds in accordance with clinical recommendations. The largest number of tests are performed to diagnose malignant neoplasms of bronchi and lungs, breast cancer and ovarian cancer. The planned number of services established in regions for outpatient molecular genetic tests correspond to federal standards or exceed them. In some regions with well-equipped laboratories with sufficient capacity, molecular genetic tests are performed for other constituent entities of the Russian Federation. The number of such procedures comprises 30-60% of all ones in the region, and payment is made through interterritorial and/or interinstitutional transactions. There is significant interterritorial differentiation in tariffs for the same molecular genetic tests. This may be due to reagents, consumables and equipment. According to experts, higher efficiency of system for organizing and paying for molecular genetic testing in oncology can be associated with federal legislative and organizational initiatives. These are approval of rules for molecular genetic testing, development of a unified methodology for compulsory medical insurance tariffs for outpatient molecular genetic testing at the federal level, approval of new nomenclature of medical services, accelerated registration of reagents and consumables. Another approach is management decisions at the level of regions (increased planned number of outpatient molecular genetic testing, expanding the list of compulsory medical insurance tariffs for molecular genetic testing, annual indexation of tariffs and their compliance with actual expenses incurred). Conclusion. A comprehensive analysis of data from 8 constituent entities of the Russian Federation revealed achievements and certain problems in organizing and paying for molecular genetic testing. The solution of the problems requires some measures to unify approaches to such testing and their pricing at the federal and regional levels.