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

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for removal of intact mammary implant (CPT 19328-50), periprosthetic capsulectomy of breast (CPT 19371-50), and breast reconstruction (CPT 19366-50). Regarding textured breast implants and anaplastic large cell lymphoma associated with breast implant (BIA-ALCL), the most recent U.S. Food and Drug Administration (FDA) recommendations state that, literature reported various estimates that BIA-ALCL may develop in 1 in between 3,817 to 30,000 women with textured breast implants. The FDA concluded that since the BIA-ALCL has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or breast asymmetry, prophylactic breast implant removal in patients without signs or symptoms is not recommended. This patient underwent complete bilateral breast reconstruction in 2014 using textured breast implants. She has no issues with the reconstruction but complains of chronic pain in her breasts, shoulders, and back as well as weakening of her pectoral muscles. The patient has expressed concern with BIA-ALCL, which has been associated with textured breast implants. The complaints of chronic pain in her breasts, shoulders, and back as well as weakening of her pectoral muscles are not documented in the medical records reviewed and do not require treatment with bilateral explantation, capsulectomies, fat injection, and mastopexies. The current recommendations for treatment of textured breast implants is for observation and follow-up. Prophylactic breast implant removal in patients without signs or symptoms is not recommended. The patient has no documented signs or symptoms of BIA-ALCL. Accordingly, the bilateral removal of intact mammary implant (CPT 19328-50), bilateral capsulectomy of breast (CPT 19371-50) and bilateral breast reconstruction (CPT 19366-50) was not medically necessary for treatment of this patient. 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 patients condition is the result of disease and treatment for breast cancer. However, the records provided for review do not document a functional deficit related to the patients breast implants. The complaints of chronic pain in her breasts, shoulders, and back as well as weakening of her pectoral muscles would not be addressed by the removal and reconstruction performed. Moreover, the provider noted that following bilateral breast reconstruction, the patient was satisfied with her appearance. Thus, the requested procedure is not being performed to improve function or create a more than minimal improvement in the patients appearance. For these reasons, the removal of intact mammary implant (CPT 19328-50), periprosthetic capsulectomy of breast (CPT 19371-50), and breast reconstruction (CPT 19366-50) were not reconstructive in nature for this patient. Final Result: The reviewer determined that the services at issue were not medically necessary and not reconstructive in nature for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. 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.