Previously, Appendix No. 5 to the Rules of Compulsory Medical Insurance (approved by Order No. 108n of the Ministry of Health of the Russian Federation dated February 28, 2019) designated certain patient actions as grounds for the non-payment or partial payment of a healthcare provider's expenses. Specifically, these grounds included instances where a patient or their representative purchased physician-prescribed medications included in the Essential Medicines List (EML) or medical devices included in the implantable medical devices registry during inpatient treatment based on clinical guidelines and healthcare standards. Furthermore, non-reimbursement applied if a medical organization administered medications supplied by the patient or a third party acting in the patient’s interest from alternative funding sources (excluding outpatient care).

Identical provisions appeared in Clause 2.10 of the Appendix to the Procedure for Auditing the Volume, Timing, Quality, and Conditions of Compulsory Medical Insurance Healthcare Delivery and Financial Security (approved by Order No. 231n of the Ministry of Health of the Russian Federation dated March 19, 2021). This Appendix establishes the comprehensive List of Grounds for Refusal of Reimbursement for Medical Care.

However, effective July 1, 2021, Order No. 696n of the Ministry of Health of the Russian Federation repealed these provisions. The amendment removed the clause stipulating that a healthcare provider’s use of medications supplied by patients or third parties from alternative funding sources constitutes grounds for non-reimbursement.

Consequently, healthcare institutions may now legally administer medications provided directly by patients or by third-party organizations acting on their behalf via alternative funding mechanisms.

This regulatory shift has sparked significant debate regarding its ultimate utility. Critics argue that the rule could effectively pressure patients into procuring necessary pharmaceuticals out-of-pocket. Various public sources contend that these amendments allow medical institutions to abdicate their primary statutory responsibility for patient drug supply.

Conversely, proponents suggest that this framework offers a pragmatic solution to mitigate localized pharmaceutical shortages and logistical delays in hospital procurement.

The explanatory note accompanying the Order highlights that the new mechanism enables charitable foundations to “supply high-cost pharmaceutical products to patients undergoing inpatient medical treatment.” Thus, the regulation establishes a lawful framework for patients and philanthropic organizations to subsidize drug supplies during inpatient hospital stays.

Guidelines require further legal precision to robustly safeguard patient rights and eliminate compliance risks.