XXXXX File No Petitioner v. Issued and entered this 28 th day of June 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND

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1 STATE OF MICHIGAN DEPARTMENT OF ENERGY, LABOR & ECONOMIC GROWTH OFFICE OF FINANCIAL AND INSURANCE REGULATION Before the Commissioner of Financial and Insurance Regulation In the matter of XXXXX File No Petitioner v. Humana Insurance Company Respondent / Issued and entered this 28 th day of June 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND On November 20, 2009, XXXXX, MD, authorized representative of XXXXX (Petitioner), filed a request for external review with the Commissioner of Financial and Insurance Regulation under the Patient s Right to Independent Review Act (PRIRA), MCL et seq. The Commissioner reviewed the request and accepted it on December 1, The Commissioner notified Humana Insurance Company (Humana) of the external review and requested the information used in making its adverse determination. The Office of Financial and Insurance Regulation received the company s information dated November 23 and December 15, The case involves medical issues so the Commissioner assigned it to an independent review organization which provided its recommendation to the Commissioner on December 15, II

2 Page 2 FACTUAL BACKGROUND The Petitioner receives health care benefits under a group policy. Her benefits are defined in a certificate of insurance issued by Humana, also called the Benefit Plan Document. On August 15, 2008, the Petitioner fell and ruptured both her breast implants. In March 2009 the Petitioner s physician requested authorization from Humana to remove the implants and perform other related surgery. Humana denied the request and the physician appealed. Humana maintained its denial and issued an adverse determination dated May 20, On May 28, 2009, the Petitioner s physician again requested authorization for the surgery. On June 30, 2009, Humana issued a denial and gave the Petitioner 180 days to file a grievance. The Petitioner s physician appealed that denial on August 12, After Humana failed to respond, the Petitioner s physician made another request on September 30, 2009, to which Humana responded with an adverse determination dated October 15, The Petitioner now requests an external review of the October 15, 2009, and earlier adverse determinations. While the record does not clearly reflect that the Petitioner exhausted Humana s internal grievance process, Humana has not disputed the Petitioner s right to an external review under PRIRA. III ISSUE Did Humana correctly deny coverage for surgery to remove the ruptured breast implants and related surgery? Petitioner s Argument IV ANALYSIS The Petitioner had breast implants placed in 1999 for cosmetic reasons. 1 In August 2008, 1 It is undisputed that the Petitioner s breast implants were for cosmetic purposes. The Petitioner said in an August 10, 2009, letter: The implant surgery that I had was a gift from my concerned sister. Having nursed two children, my breasts were left virtually deformed. She told me that this would restore my breasts to what they once were. I accepted

3 Page 3 while walking her dog, she was dragged down an embankment. According to the Petitioner, the fall resulted in severe facial trauma and bruising, a hematoma on the inside of her lower lip, and a torn rotator cuff. She subsequently developed nodularity in both breasts and further testing revealed that both breast implants had ruptured, producing capsular contractures that caused pain. The silicone implants also leaked, producing lumps. Because of the pain, Dr. XXXXX, the Petitioner s plastic surgeon, requested coverage from Humana for breast surgery. Dr. XXXXX contends the surgery is medically necessary due to the injuries she sustained. In a March 16, 2009, pre-authorization letter to Humana, he outlined the proposed treatment: [The Petitioner] was walking her dog in August 2008 when the dog started to chase a squirrel and she fell directly onto her chest wall as well as her chin. She underwent an emergency room evaluation and a CT scan of the face revealed no fractures but she has developed a firm nodularity in both the right and left breast and eventually underwent mammogram which revealed a left breast implant rupture and an ultrasound confirmed this. In addition she has a firm mass in her right breast which is likely an implant rupture as well. Because of this she will require correction which would include removal of implant material and replacement with permanent silicone implants through re-augmentation and bilateral mastopexy due to the severe distortion of the breast tissue that has occurred secondary to this accident. She thus has the following ICD-9 coded diagnosis: Mechanical complication of breast prosthesis (bilateral breast implant rupture, left extra-capsular and right probable extracapsular) Asymmetry with breast ptosis right and left breast secondary to implant rupture Left breast mass Right breast mass. In order to treat these problems she will require the following CPT coded procedure: Removal of left breast implant material (ruptured.) Removal of right breast implant material (ruptured.) Immediate reinsertion of right silicone implant following the above Immediate reinsertion of left silicone implant following the above Right breast mastopexy to obtain symmetry Left breast mastopexy to obtain symmetry Complete left periprosthetic capsulectomy. this gift.

4 Page Complete right periprosthetic capsulectomy. The Petitioner argues that the need for these procedures did not the result from her earlier cosmetic breast surgery -- she says she had no complications at all from that surgery. She says the procedures are needed because of an accidental injury that ruptured the implants. Therefore, the Petitioner believes the services should be covered. Humana Insurance Company s Argument In a letter to Dr. XXXXX dated May 20, 2009, in response to his request for an expedited appeal, Humana denied authorization for all the services he requested: [Humana] denied the expedited appeal because we determined the requested complete capsulectomy, implant removal with replacement and bilateral mastopexy for symmetry is [sic] not a covered expense according to the [Petitioner s] Benefit Plan Document. Humana cites these provisions in the Limitations and Exclusions section of the Benefit Plan Document (pp ) as the bases for its decision: Other limitations and exclusions Unless specifically stated otherwise, no benefits will be provided for, or on account of, the following items: * * * Cosmetic surgery and cosmetic services or devices, unless for reconstructive surgery: -- Resulting from a bodily injury, infection or other disease of the involved part, when functional impairment is present; or -- Resulting from congenital disease or anomaly of a covered dependent child which resulted in a functional impairment. A functional impairment is defined as a direct measurable reduction of physical performance of an organ or body part. Expense incurred for reconstructive surgery performed due to the presence of a psychological condition are not covered, unless the condition(s) described above are also met. * * * Expenses for care and treatment of non-covered procedures or services. Expenses for treatment of complications of non-covered procedures or services.

5 Page 5 In a June 30, 2009, letter to the Petitioner, Humana explained: According to Medical Director review, your original surgery for breast implants was considered a cosmetic procedure, which is not a covered service. Your Benefit Plan Document contains a direct exclusion for expenses for the treatment of complications from non-covered procedures. Therefore, the removal of breast implants, a complication of a non-covered procedure has been denied. Finally, in its October 15, 2009, adverse determination Humana denied authorization for removal of the breast implants because the services sought are cosmetic and cosmetic surgery and services are excluded under the terms of the Petitioner s coverage: All information submitted has been reviewed and the service(s) indicated below are not included as a covered benefit according to the plan provisions of the member s Benefit Plan Document. The denied services are: ICD-9 Diagnosis, , Mechanical complication due to beast prosthesis, and for procedure 19330, Removal of mammary implant material. The reason for the denial is due to the following: This is considered cosmetic. Humana believes that it correctly denied authorization for the requested services because they are either explicitly not covered or are for treatment of complications of a non-covered procedure or service (i.e., the earlier cosmetic surgery). Commissioner s Review In order to evaluate the surgical services requested by the Petitioner, the Commissioner referred this matter to an independent review organization (IRO). The IRO reviewer is certified by the American Board of Plastic Surgery; a diplomate of the American Board of Surgery; a member of the American Society of Plastic and Reconstructive Surgeons; and in active practice. The IRO reviewer concluded that the mastopexies and implant replacements are cosmetic but the implant removal and capsulectomies are medically necessary. Regarding the mastopexies and implant replacements, the IRO reviewer said:

6 Page 6 The [Petitioner s] original breast augmentation was performed for cosmetic indications. Mastopexies and replacement of the breast implants are being requested to improve the appearance of her breasts. She has not had mastectomies, and breast augmentation does not treat any functional or health problems. These procedures are cosmetic, therefore not a covered benefit. The Commissioner accepts the opinion of the IRO reviewer and finds that the mastopexies and replacement implants are cosmetic procedures. That opinion is based on extensive expertise and professional judgment and the Commissioner finds no reason to reject it. MCL (16)(b). Since the Benefit Plan Document excludes coverage for cosmetic procedures, the Commissioner finds that the mastopexies and replacement implants are not covered under the Petitioner s health care plan. The IRO reviewer also opined that the removal of the implants and capsulectomies were medically necessary. The IRO reviewer said: Although the literature does not support routine breast implant removal for ruptured implants, the FDA Advisory Panel, in agreement with breast implant maker Inamed s recommendations, has stated that ruptured silicone implants should be routinely removed (11-13). According to the FDA website, The diagnosis of rupture of a gel-filled breast implant is important because the release of silicone gel and fluid into the tissues may result in local complications. An intracapsular rupture may become extracapsular, and both are generally agreed to indicate the need for removal of the implant. The American Society of Plastic Surgeons (ASPS) supports this recommendation (14). According to the ASPS Position Paper on Reoperation for Implants Placed for Cosmetic Augmentation, the medically necessary conditions for reoperation are broken or failed implant, infection, implant extrusion, siliconoma or granuloma, interference with the diagnosis with the diagnosis or treatment of breast cancer. Although the scientific evidence supporting routine removal of breast implants is lacking, it is not appropriate to deny breast implant removal in face of the FDA recommendation to remove all ruptured breast implants. Based on the FDA recommendations, but not on the medical literature, bilateral breast implant removal is medically necessary. Capsulectomies are also medically necessary as the medical literature suggests that retained capsules following silicone implant explantation can interfere with mammography and can lead to cysts and seromas (15, 16). The Commissioner accepts the opinion of the IRO reviewer that it is medically necessary to remove the ruptured breast implants. However, medical necessity is not the dispositive question.

7 Page 7 The Commissioner s order cannot be grounded solely in the IRO report -- the terms and conditions of the Benefit Plan Document are also relevant. The Benefit Plan Document not only excludes cosmetic surgery (a non-covered procedure), it also excludes coverage for treatment of complications of non-covered procedures or services. It is Humana s position that the removal of the ruptured breast implants is treatment of complications of a non-covered procedure and therefore not a covered benefit. The Petitioner argues that the need to remove the ruptured breast implants arose not from complications of her earlier cosmetic surgery but as the result of a traumatic injury that would otherwise be covered under the terms of her health plan. The word complication is not defined in the Benefit Plan Document so the Commissioner must determine its meaning as it is used here. The Commissioner finds nothing in the record from which he could conclude that the injury was a complication of the non-covered cosmetic breast implants she had in The injury was not a secondary disease or a negative reaction to the breast implants. This is not a case where, following the placement of implants, an infection developed or the implants began deteriorating or leaking and needed to be removed -- those situations would clearly not be covered under the Benefit Plan Document. The need to remove the breast implants resulted from an accidental injury unrelated to the cosmetic surgery, i.e., it is a complication of the Petitioner s fall, not a complication of the earlier placing of breast implants. A common definition of complication is something that introduces, usually unexpectedly, some difficulty, problem, change, etc. 3 It was the fall in August 2008 that introduced the complications, not the cosmetic surgery. 2 This date was reported in Dr. XXXXX s May 16, 2009, letter; the Petitioner said she had the implants twenty years ago. 3 complication. Dictionary.com. Dictionary.com Unabridged. Random House, Inc. (accessed: May 20, 2010).

8 Page 8 It may be that Humana intended to exclude from coverage everything related in any way to non-covered services, expenses for treatment of complications of non-covered procedures or services. V ORDER The Commissioner reverses in part Humana s adverse determination. Humana s is not responsible for mastopexies and augmentations. However, Humana shall authorize and cover the removal of the implants and the capsulectomies subject to the terms of its Benefit Plan Document within sixty days from the date of this Order. Humana shall, within seven days of providing coverage, provide the Commissioner proof it has implemented the Commissioner s Order. To enforce this Order, the Petitioner may report any complaint regarding implementation to the Office of Financial and Insurance Regulation, Health Plans Division, on its toll free number This is a final decision of an administrative agency. Under MCL , any person aggrieved by this Order may seek judicial review no later than sixty days from the date of this Order in the circuit court for the county where the covered person resides or in the circuit court of Ingham County. A copy of the petition for judicial review should be sent to the Commissioner of the Office of Financial and Insurance Regulation, Health Plans Division, Post Office Box 30220, Lansing, MI