Implant Removal denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for breast implant removal surgery (CPT 19371-RT, 19371-LT, 19328-RT, and 19328-LT) performed by Dr. Lisa Cassileth on 11/02/20.At issue is whether breast implant removal surgery (CPT 19371-RT, 19371-LT, 19328-RT, and 19328-LT) performed by Dr. Lisa Cassileth on 11/02/20 was medically necessary for treatment of the patient’s medical condition. Does the condition constitute an abnormal structure of the body? If so, is the abnormal structure of the body caused by any of the following: congenital effects, developmental abnormalities, trauma, infection, tumors, or disease? If so, is the requested surgery performed to do either of the following: improve function or create a normal appearance to the extent possible?

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral breast implant removal including scar tissue removal and implant replacement surgery. An exhaustive review of the current medical literature pertaining to breast cancer reconstruction reveals that breast reconstruction results in improvement in quality-of-life (QOL). Researchers report that QOL scores improves dramatically after breast reconstruction for women who initially had not had breast reconstruction. Additionally, researchers also note that mastectomy followed by reconstruction preserved the QOL, although the QOL benefit depended on patients’ life status at inclusion, with young active women more likely to preserve their QOL after immediate breast reconstruction.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral peri-implant capsulectomy and bilateral breast implant removal. Capsular contracture is a complication of breast implants that may require revision surgery. The authors noted that “Capsular contracture initially presents with firmness of the breast and can progress to pain and distortion of the breast shape and volume. When an implant is placed, a fibrous capsule forms around it. In a normal breast, the capsule is thin and soft, with no effect on the appearance of the breast. In a contracted breast, the capsule becomes thick and hard, and shrinks in a way which alters the contour of the breast and the position of the implant.” A study describes the Baker classification of capsular contracture after breast augmentation. Grade I capsular contracture is asymptomatic.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for surgery to remove and replace bilateral implants with smooth silicone implants.The present best medical opinion is that prophylactic replacement of textured breast implants with smooth implants to reduce the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not medically necessary, and replacement of textured breast implants with smooth implants for the treatment of capsular contracture is not medically indicated. Regarding textured breast implants and BIA-ALCL with risk of lymphoma, the U.S. Food and Drug Administration (FDA) stated in 2019 that current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Implant Removal, then check the rights and deadlines that apply to your plan.