Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral breast implant removal, bilateral capsulectomy, bilateral breast reconstruction, and bilateral reinsertion of breast implants to be performed in one surgical procedure. Researchers state 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. 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. Capsular contracture is the most common complication following implant-based breast surgery and is one of the most common reasons for reoperation. There is a consensus that symptomatic or extracapsular implant rupture warrants explantation, with or without, implant replacement. The current literature supports explantation when the signs of silicone migration such as pain, lumps, granulomas, and increasing fibrosis are present. Treatment for asymptomatic implant ruptures remains controversial. In most instances, implant rupture does not produce significant clinical symptoms or activate the humoral immune system. If the patient undergoes explantation surgery, the patient may choose to replace one or both implants with saline or silicone implant(s). Whether to remove the capsule at the time of replacement is dependent on the amount of thickening, calcification and silicone leakage found, and the providers judgment. A study noted that, capsulectomy should be performed in patients with ruptured silicone gel implants, in patients with severe capsular contracture, or when the capsule contains large amounts of calcium deposits. Researchers also state that a severely contracted capsule which is left in place can produce a breast deformity and palpable mass. The authors that there are concerns that this residual capsule can also interfere with mammography.For bilateral breast implant removal, the left breast has an asymptomatic intracapsular rupture of a silicone gel breast implant placed for cosmetic purposes. There is no specific health risk present due to the intracapsular implant rupture of the left breast and there is no documented functional disability. The removal of the left, asymptomatic ruptured intracapsular breast implant is not medically necessary. The right breast is painful, hard, and distorted. The provider will remove the right breast implant in the course of the right breast capsulectomy, as it is not a separate procedure. Further, under the California Reconstructive Surgery Statute, the procedure is not reconstructive in nature. 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; or (2) to create a normal appearance, to the extent possible. A cosmetic implant is not an abnormal structure of the body. Therefore, bilateral breast implant removal, is not medically necessary and not reconstructive in nature for treatment of this patient.  With regard to bilateral capsulectomy, the records support this procedure for the patients right breast. The records document that this patient has a left breast asymptomatic intracapsular rupture of a silicone breast implant placed for cosmetic purposes. There is no reported capsular contracture. There is no pain, functional loss, or reported disability to support capsulectomy of the left breast as medically necessary. The left breast is not associated with any functional loss and the appearance is described as within normal limits. Thus, the capsulectomy of the left breast is not reconstructive in nature. The patient has a right breast Grade IV capsule with pain and distortion following radiation therapy for carcinoma. This capsule is present in the breast previously treated with radiation therapy. Further, the presence of a Grade IV capsule is likely to interfere with mammography. Therefore, capsulectomy of the right breast is medically necessary and thus, reconstructive in nature. In addition, bilateral breast reconstruction is not medically necessary or reconstructive in nature. The patient has bilateral breasts present, which is within normal limits for a female. There is no documented functional impairment. Overall, the records do not support an indication for breast reconstruction to improve function or create a more normal appearance. Further, bilateral reinsertion of breast implants is not medically necessary. The breast implants were placed for cosmetic purposes, and reinsertion of the implants would be for cosmetic purposes. Replacement of cosmetic breast implants is not medically necessary. Moreover, a cosmetic implant is not an abnormal structure of the body. As there is no functional impairment or presence of an abnormal structure of the body, the requested service is not reconstructive in nature. Considering the current literature, a right breast capsulectomy, is medically necessary for treatment of this patients right breast painful contracture following radiation therapy for carcinoma. Final Result: The reviewer determined that a portion of the requested services are medically necessary and reconstructive in nature for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in plastic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.