Re-operation on Women W/ Breast Implants

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ASPS Position PaperReoperation on Women with Breast Implants: Recommended Criteria for Third-Party Payer Coverage

Background The American Society of Plastic Surgeons (ASPS) is the largest organization of plastic surgeons in the world. Requirements for membership include certification by the American Board of Plastic Surgery. As the umbrella organization for the specialty, ASPS represents 97 percent of 5,000 of the board-certified surgeons practicing in the United States and Canada. It serves as the primary educational resource for plastic surgeons and as their voice on socioeconomic issues. ASPS is recognized by the American Medical Association (AMA), the American College of Surgeons (ACS) and other organizations of specialty societies. The Issues The Food and Drug Administration (FDA) panel advises that women with implants see their physicians regularly and, if an implant is found to have ruptured, to have it removed. The FDA advises that women who are not experiencing problems with their implants need not have their implant removed. The normal risk associated with any surgical procedure is likely to be greater than any real or speculative risk from retaining the implant. Periodic checkups are advised. Conflicting media coverage of the breast implant issue has created fear and confusion among women who have breast implants. Some women are requesting removal of their implant(s), irrespective of whether or not a causal relationship between implants and certain diseases has been scientifically documented, and they are looking to third-party payers for coverage. The appropriate role for third-party payers on this issue is unclear. The role of ASPS on the breast implant issue is that of patient advocate. The ultimate goal is to provide appropriate medical attention for women with breast implants. This position paper, while acknowledging the contractual issues of health insurance, seeks to identify the medically necessary indications which justify coverage for re-operation on women with implants. Third-Party Payers Third-party payers traditionally have provided coverage for treatment of medical disorders and diseases of the breast. This includes treatment for breast cancer, pre-malignant disorders, abscesses, masses, parenchymal calcification, lactation disorders and other conditions known to occur in the female breast, irrespective of the presence of implants. ASPS anticipates that carriers will continue to cover their insured for medically necessary treatment of breast disorders. In general, it is expected that a patient who has received an implant(s) for reconstructive purposes and was covered for that procedure should also be covered for any medically necessary re-operation. Definition of Cosmetic and Reconstructive Surgery For reference, the following definition of cosmetic and reconstructive surgery was adopted the American medical Association, June 1989.

Cosmetic surgery is performed to reshape normal structures of the body in order to improve the patient's appearance and self-esteem. Reconstructive surgery is performed on abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumor or disease. It is generally performed to improve function but may also be done to approximate a normal appearance. Patients With Implant(s) Placed for Reconstructive Purposes

For a patient who has had an implant(s) placed for reconstructive purposes, ASPS considers treatment of any one of more of the following conditions (with appropriate ICD-9 diagnosis codes) to be medically necessary and, therefore, compensable by third-party payers:

Broken of failed implant (996.54) Infection (996.6) Implant extrusion (879.1) Siliconoma or granuloma (728.82) Interference with diagnosis or treatment of breast cancer Significant patient fear that the implant(s) may affect health* Concurrent systemic symptoms that the patient believes may be related to the breast implant(s) Breast pain (611.71) Painful capsular contracture with disfigurement (996.79) Significant implant malposition (996.54) In unusual circumstances , in consultation with a psychiatrist diagnosis codes for fear may used. It is recognized that carriers generally cover re-operation on a case-by-case basis for women who have had breast construction. For a patient who has had an implant(s) placed for reconstructive purposes, ASPS recommends that third-party payers consider claims for the following conditions thoughtfully and with compassion on an individual basis:

Patient's desire for exchange of implants because of concern for the integrity of the implant(s) Unsatisfactory aesthetic outcome Patients with Implants for Cosmetic Augmentation For a patient with implants placed for cosmetic purposes, ASPS considers treatment of any one or more of the following conditions to be medically necessary and, therefore, compensable by third-party payers:

Broken or failed implant (996.54) Infection (996.6) Implant extrusion (879.1) Siliconoma or granuloma (728.82) Interference with diagnosis or treatment of breast cancer For a patient with implants placed for cosmetic purposes, ASPS requests that carriers respond to their insured thoughtfully and with compassion on an individual basis for the following conditions:

Confirmed diagnosis of mastodynia (611.7) Significant patient fear that the implant(s) may affect health (300.29) Concurrent systemic symptoms that the patient believes may be related to the breast implant(s) Medically significant capsular contracture (capsular contracture that produces pain, disfigurement and/or interferes with mammography) For a woman who has had implant placed for cosmetic purposes, ASPS considers treatment of any one the following conditions to be elective:

Unsatisfactory aesthetic outcome Desire for exchange of implants Bilateral Surgery If a patient has bilateral implant and a medically necessary procedure is performed on one breast (for example, removal and/or replacement of ruptured implant), it is the opinion of ASPS that coverage of any surgery performed on the other side during the same operation should be evaluated by carriers using the same criteria. Procedures Because insurance documents and medical records are part of a patient's permanent record and may affect future insurability accurate terminology is essential:

Removal in intact mammary implant (CPT Code: 19328) Removal of mammary implant material (CPT Code: 19330) Immediate insertion of breast following mastopexy, mastectomy or in reconstruction (CPT Code: 19340) Delayed insertion of breast prosthesis following mastopexy, mastectomy or in breast reconstruction (CPT Code: 19342) Open periprosthetic breast capsulectomy (CPT Code: 19371) Documentation When re-operation is performed on a woman with a breast implant(s) the symptoms, signs and clinical indication should be documented by the surgeon not only in the charted history and physical examination section but also in the operative note. Prior Authorization/Pre-Determination Prior authorization or pre-determination by third-party payers is strongly recommended prior to re-operation on a woman with implants. By using prior authorization of pre-determination, physicians, patients and third-party payers can properly determine the medical necessity of reimbursable procedures. ASPS recognizes that carriers will be guided by the indication for re-operation, the contract language of each patient's policy and the company's practice. It is recognized that insurance contracts are issued for many different levels of coverage. Failure to present clear clinical evidence of indications for re-operation(s) is recommended ground for expert medical review, possible reclassification as cosmetic (non-covered) surgery, and denial of third-party payer payment. Related Issues Pathological Evaluation - If a woman decides to have her implant(s) removed, it is recommended that the condition of the implant be recorded. This can be done by a detailed description in the operative note by the surgeon, photographs and/or review by a pathologist. Occasionally, the implant is returned to the manufacturer on ongoing studies. The right to decide on the final disposition of the implant belongs to the patient. If any tissue is removed, it is recommended that it be evaluated by a pathologist in the same manner as any other tissue removed from the body. Financial Assistance - Some implant patients may be eligible for financial assistance offered by an implant manufacturer. Plastic surgeons are encouraged to assist patients in investigating this option. Surgical Fees - The appropriate fee for any surgical procedure is determined by the individual plastic surgeon. ASPS encourages its members to respond thoughtfully and compassionately to patient concerns, as well as to minimize the financial impact on the individual. The ultimate objective of the surgeon is to provide appropriate medical attention for the patient. References

Medical Alert, Food and Drug Administration, January 6, 1992. Talk paper, Food and Drug Administration, February 20, 1992. Statement by A. Kessler, MD, Commissioner of Food and Drugs, April 16, 1992. "Breast Implants," American Medical Association, Report M of the Council on Scientific Affairs, December 1991. Guidelines for Health Benefits Administration: Prior Authorization, Claims Submission and Review, American Medical Association, Blue Cross Shield Association, Health Insurance Association of American, 1989. Prepared by the Socioeconomic Committee Approved by American Society of Plastic Surgeons Board of Directors, June, 1994.

© Copyright 1994 American Society of Plastic Surgeons