Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 
The patient is a 44-year-old female who is status post bilateral subglandular breast augmentation in 1997. The patient has requested reimbursement for bilateral breast surgery services (CPT code 19371-50) performed on 3/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Tervaert and colleagues stated, Autoimmune/inflammatory syndrome by adjuvants (ASIA), allergies, autoimmune diseases, immune deficiencies and lymphomas occur in patients with silicone breast implants. There is a need for adequately adjusted epidemiological studies to ascertain the frequency of these diseases. On the other hand, Balk and colleagues stated, The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Chao and colleagues stated, Breast implant surgery is one of the most commonly performed procedures in the field of plastic surgery. While silicone implants are now routinely used in breast surgery, they have previously been the subject of controversy. This was particularly true in the U.S., where there was a moratorium on their use from 1992 to 2006. Following subsequent scientific validation of their safety, silicone implants have re-gained widespread acceptance for clinical use. Overall, silicone breast implants are associated with a high degree of patient satisfaction and low rates of complications. Further independent research is necessary to better establish long-term outcomes. This patient reported generalized complaints of hives and migraine headaches in which association with the presence of silicone gel implants cannot be confirmed. They are systemic complaints in which causation from silicone gel implants is speculative and unsupported. There is also no report that the patient actually had silicone gel implants rather than saline implants, in which association with autoimmune disease is not claimed. Based on the medical information received for review, removal of the breast implants because of hives or migraine is not medically necessary. Wan and Rohrich stated that clinically significant capsular contracture presents as a firm, tight-appearing breast that may progress to breast distortion and pain. The Baker classification describes four grades of capsular contracture, with grade I being a normal, soft breast; grade II being a minimally firm breast; grade III being a moderately firm breast with some visible deformity; and IV being a painful, hard, distorted breast. Grade III and IV contractures typically require surgical management. Headon and colleagues noted that traditionally, capsular contracture is treated surgically, although it is important to note that treatment is only indicated in grades III and IV capsular contracture. This patient reported pain in her breasts for years, and she complained of pain when lying on her side. No physical examination was received for review reporting a grade III or grade IV capsular contracture, and no photographs were received for review documenting a grade III or grade IV capsular contracture. Based on the medical information received for review, removal of the breast implants with capsulectomies is not medically necessary. The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) to improve function; (2) to create a normal appearance, to the extent possible. The presence of a cosmetic implant does not constitute an abnormal structure of the body. A breast capsule can be an abnormal structure of the body if it is grade III or grade IV, but it is not caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease. The reconstructive surgery statute does not apply to this patient. Therefore, bilateral breast surgery services (CPT code 19371-50) performed on 3/05/21 were not reconstructive in nature.