[Press Release] Medical Expense Insurance Companies Conduct Comprehensive Investigation into Knee Bone Marrow Stem Cell Injection Costs
Medical expense insurance companies are conducting a full investigation into the cost of knee bone marrow stem cell injections. Equipment and materials used vary widely by hospital… On-site investigation underwayRecently, there has been a rise in cases of “knee stem cell injections” for various types of knee arthritis. Consequently, medical expense insurance companies are reportedly conducting a comprehensive investigation into the cost of knee bone marrow stem cell injections. The New Medical Technology Assessment Report on Intra-Articular Bone Marrow Aspirate Concentrate Injection for Knee Osteoarthritis (Ministry of Health and Welfare Notice No. 2023-128) specifies the procedure as “centrifuging autologous bone marrow from the patient’s iliac crest and injecting the concentrated ‘bone marrow stem cells’ into the knee joint.” According to the Ministry of Food and Drug Safety, “If a company intends to promote bone marrow stem cell therapy, it must submit supporting data regarding the isolation and identification of the relevant component (Article 29, Paragraph 1, Subparagraphs 2, 3, and 8 of the Regulations on Medical Device Approval, Reporting, and Review, etc.). Depending on the intended content, this data may include an equivalence evaluation with an already approved product or a standalone evaluation of the product being applied for.” The Ministry further states, “Depending on the intended content, clinical trial data may also be required.” While bone marrow stem cell injections are generally used for the treatment of patients with knee osteoarthritis, as per the Ministry of Health and Welfare’s notice, some hospitals and clinics are using bone marrow cell layers that have not been validated as stem cells or concentrating bone marrow in blood vessels. Therefore, patients should be cautious before undergoing the procedure. Orthopedic clinics and nursing hospitals nationwide have introduced bone marrow stem cell injections for knee osteoarthritis, and the number of patients receiving the treatment is increasing. Consequently, insurance companies are reportedly receiving a steady stream of claims for actual loss insurance. A physical damage adjuster from the long-term compensation support team of an insurance company said, “The claims amount varies from as little as 1 million won to as much as 16 million won, and there are many hospitals that have overcharged the amounts, so we have formed an investigation team and are conducting on-site inspections.” He added, “Since the equipment and treatment materials used by each hospital vary greatly, we are requiring that the manufacturing lot number and serial number be written on the name of the equipment used for bone marrow infusion. We are also requesting that hospitals attach a copy of the Ministry of Food and Drug Safety approval to show which stem cell extraction system was used for the treatment and whether a stem cell-approved product was used.” Reporter Lee Jeong-hee kunkang1983@naver.com Source: Health Digest (http://www.ikunkang.com/news/articleView.html?idxno=39228)