Patients who are treated in hospitals with their own drugs or medicines from donors may have problems with medical care. Since the beginning of the summer, the Federal Compulsory Medical Insurance Fund (FFOMS) has the right to refuse state clinics to finance the treatment of such patients. A whole pool of charitable foundations was under attack, including the Circle of Kindness created by the presidential decree: they buy drugs abroad not registered in Russia for cancer patients and children with rare diseases. The department has already promised to amend the new rules so that patients can continue to receive medicines from funds without hindrance.
Several industry lawyers told Kommersant that the FFOMS may cut funding or even refuse to pay state clinics for inpatient medical care for patients treated with their own drugs. The new procedure came into force at the beginning of this summer: its conditions are enshrined in clause 2.10 of the annex to the order of the Ministry of Health No. 231n of March 19, 2021. It also states that budgetary medical institutions may lose payment from the compulsory medical insurance funds if the drugs are “provided by another organization acting in the interests of the patient from other sources of funding.”
The innovation may limit the possibilities of using the resources of charitable organizations, including the Circle of Good Foundation, believes Sergei Klimenko, partner of the law firm Dentons. This fund was created in January 2021 by decree of the President of the Russian Federation Vladimir Putin to treat children with rare diseases. Its budget is formed from funds received as a result of an increase in the personal income tax rate for citizens with incomes of more than 5 million rubles. in year.
So far, patients with spinal muscular atrophy (SMA) have not faced difficulties in obtaining medical services through compulsory medical insurance, but the adoption of new rules may lead to problems in the future, agrees Olga Germanenko, director of the SMA Family Foundation. “Such patients are treated in hospitals with spinraza, which the Circle of Kindness promised to provide, or risdiplam purchased by benefactors,” she explains.
Difficulties may also affect patients with hematological oncological diseases, says Alexei Fedorov, an independent expert on public procurement. According to him, until mid-2020, patients with acute lymphoblastic leukemia received oncaspar, which had lost its registration in the Russian Federation, entirely at the expense of benefactors. In 2019, the Give Life Foundation alone imported 216 bottles of the drug worth 35.5 million rubles into the country. “Often such patients need to start therapy immediately after diagnosis, but the existing system of public procurement, due to the length of the procedures, is not able to provide them with medicine promptly,” adds Mr. Fedorov. The Krug of Kindness, Gift of Life funds and the Rogachev Center (provides patients with oncaspar) did not provide comments.
The FFOMS told Kommersant that new restrictions were introduced to exclude double financing of drug provision from the fund and other sources. They promised that financial sanctions will not be applied to medical institutions “if the use of drugs purchased at the expense of charitable foundations and other organizations is carried out in compliance with the rules and payment mechanisms.” To avoid an ambiguous interpretation of the clause of the order, which caused a negative reaction from patients and benefactors, amendments are now being made to the control procedure, the FFOMS said.
The Ministry of Health explained that according to the law, state clinics can use drugs purchased by other organizations, highlighting the introduction of such drugs in a separate tariff. But the problem is that not all regions have approved a tariff that involves only the introduction of the drug, say lawyers interviewed by Kommersant.
The new procedure for monitoring the provision of medical care will not affect the receipt of drugs from the “official normatively fixed sources of financing for medical care”, which include the Circle of Kindness fund, hopes Dmitry Kuznetsov, vice president of the All-Russian Union of Insurers. But he agrees that the innovation introduces ambiguity and should be clarified by the regulator.