XXXXX Petitioner File No v. Issued and entered this _12th_ day of October 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND

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1 In the matter of STATE OF MICHIGAN DEPARTMENT OF ENERGY, LABOR & ECONOMIC GROWTH OFFICE OF FINANCIAL AND INSURANCE REGULATION Before the Commissioner of Financial and Insurance Regulation XXXXX Petitioner File No v Physicians Health Plan of Mid-Michigan Respondent / Issued and entered this _12th_ day of October 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND On July 12, 2010, 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 Petitioner receives health care benefits under a certificate of coverage issued by Physicians Health Plan of Mid-Michigan (PHP). PHP denied coverage for weight loss surgery which Petitioner had requested. When it received Petitioner s appeal, the Office of Financial and Insurance Regulation (OFIR) requested that PHP provide the information it used in making its final adverse determination. The information was received on July 16, Petitioner s request for review was accepted on July 19, The case involves medical issues so the Commissioner assigned the matter to an independent review organization which completed its review and sent its recommendation to the Commissioner on July 30, 2010.

2 Page 2 II FACTUAL BACKGROUND Petitioner has a history of morbid obesity. In January 2010, she requested that PHP provide coverage for bariatric surgery. At the time she requested her surgery, Petitioner weighed pounds and had a body mass index of 48.27, a figure consistent with extreme obesity. She also has diabetes, arterial stenosis, and arthosclerosis of the aorta. Because of these conditions, her surgeon requested gastric sleeve bypass surgery. PHP denied the request as it considers this procedure to be an unproven service that is excluded under the terms of the PHP certificate. PHP cited no other reason for denying coverage. Petitioner appealed PHP s denial of coverage for the requested surgery. PHP reviewed Petitioner s appeal, but upheld its original determination in a final adverse determination dated June 30, III ISSUE Did PHP properly deny the Petitioner coverage for gastric sleeve bypass surgery under the terms of the certificate? Petitioner s Argument IV ANALYSIS Petitioner says she tried to lose weight by attempting many diets (Weight Watchers, SlimFast, Atkins and the Cambridge diet) and a weight loss program including Sparrow Hospital s weight management program before deciding on bariatric surgery. Her efforts were unsuccessful and she then considered weight loss surgery. In her letter of appeal, she wrote: The gastric sleeve uses the stomach and its lining offering protection from the corrosive effects of aspirin and Plavix over time. I ll have to take aspirin and Plavix the rest of my life because I have atherosclerosis. The roux-en-y creates a pouch at the bottom of the esophagus which does not have the stomachs lining. Leaving itself unprotected from corrosion unlike the gastric sleeve. By having this procedure I could eliminate 17 of the 20 pills I now take daily due to diabetes and high blood pressure. I take Actos Plus Met

3 Page 3 for diabetes. Actos is now known to contribute to congestive heart failure. I already take 80mg of Lasix and 40meq of Potassium per day because of the edema in my ankles caused by the Actos. I don t like where this is heading me. I feel the gastric sleeve will greatly lessen my chances for liver and or kidney failure in the future brought on by multiple medications I now take on a daily basis. * * * At support meetings, I hear testimonials all the time about persons getting off medications and their diabetes is gone within a few months after surgery. No more sleep apnea and high blood pressure returned to normal ranges. Heart health improved because of increased ability to exercise. All this resulted in overall improved health, fewer prescriptions, less claims and reduced insurance [company] costs. Petitioner also cites several articles to prove that gastric sleeve bypass surgery is medically necessary, is not unproven, and is her safest alternative. Her physician, XXXXX, M.D., also supports this position, stating in a January 2010 pre-authorization request to PHP: [Petitioner s] cardiac condition, which includes right subclavian artery stenosis s/p stent, and arthrosclerosis of the aorta, and the fact that she is taking daily Plavix and aspirin is cause for careful consideration as to which procedure would be best. Gastric Roux-en-Y Bypass surgery would not be the best choice of procedure as this could significantly increase the chance of bleeding. It is my opinion that the Gastric Sleeve is the best and safest procedure for her. Petitioner argues PHP should provide coverage for the surgery. Respondent s Argument In its final adverse determination PHP stated that the requested surgery is unproven and therefore specifically excluded from coverage. PHP based its denial on the following provisions of Petitioner s certificate of coverage: Section 2: What s Not Covered Exclusions * * * G. Experimental, Investigational or Unproven Services Experimental, Investigational and Unproven Services are excluded. The fact that an Experimental, Investigational or Unproven Service, treatment, device or pharmacological regimen is the only available treatment for a particular condition will not result in Benefits if the procedure is considered to be Experimental, Investigational or Unproven in the treatment of that particular condition....

4 Page 4 Section 10: Glossary of Defined Terms * * * Unproven Services services that are not consistent with conclusions of prevailing medical research which demonstrate that the health service has a beneficial effect on health outcomes and that are not based on trials that meet either of the following designs. Well-conducted randomized controlled trials. (Two or more treatments are compared to each other, and the patient is not allowed to choose which treatment is received.) Well-conducted cohort studies. (Patients who receive study treatment are compared to a group of patients who receive standard therapy. The comparison group must be nearly identical to the study treatment group.) Decisions about whether to cover new technologies, procedures and treatments will be consistent with conclusions of prevailing medical research, based on well-conducted randomized trials or cohort studies, as described. If you have a life-threatening Sickness or condition (one that is likely to cause death within one year of the request for treatment) we may, in our discretion, determine that an Unproven Service meets the definition of a Covered Health Service for that Sickness or condition. For this to take place, we must determine that the procedure or treatment is promising, but unproven, and that the service uses a specific research protocol that meets standards equivalent to those defined by the National Institutes of Health. PHP also relied upon the analysis of Hayes, a private medical research firm, whose guidelines state that [t]here are no controlled prospective studies comparing the efficacy and safety of laparoscopic sleeve gastrectomy with that of standard bariatric procedures for super obesity. PHP therefore maintains that gastric sleeve bypass surgery is still unproven and its denial was appropriate under the terms of the certificate. Commissioner s Review In order to answer the question of whether gastric sleeve bypass surgery is unproven, the Commissioner obtained the analysis of an independent review organization (IRO) as required by section 11(6) of PRIRA, MCL (6). The review was conducted by a physician with an active clinical practice who is certified in surgery and specializes in bariatric surgery. The IRO reviewer recommended overturning PHP s denial of sleeve gastrectomy: [L]aparoscopic vertical sleeve gastrectomy is approved as a primary treatment for morbid obesity for appropriate patients by the American College of Surgeons, SAGES [the Society of American Gastrointestinal and

5 Page 5 Endoscopic Surgeons] and the American Society for Metabolic and Bariatric Surgery based upon the available literature documenting the safety and efficacy of this procedure.... [Five] year outcome data has been reported regarding this procedure.... [R]eports of this procedure describe treatment of patients with preoperative body mass indices ranging form 35 to [T]he reported percent of excess weight loss following this procedure ranges from 33% to 85% with an overall mean of 55%.... [T]hese studies demonstrate comparable rates of improvement and remission of diabetes, hypertension, hyperlipidemia and sleep apnea as seen with other restrictive bariatric procedures.... [M]ajor complication rates with these studies are relatively low. Therefore... laparoscopic vertical sleeve gastrectomy is not unproven/investigational at this time. (Citations omitted here are included in the complete IRO report provided to the parties.) The Commissioner is not required in all instances to accept the IRO s recommendation. However, the Commissioner gives deference to the IRO recommendation since it is based on extensive expertise and professional judgment. The Commissioner, discerning no reason to reject the recommendation in this case, accepts the IRO reviewer s determination that sleeve gastrectomy is not unproven. certificate. The Commissioner finds PHP s denial is not consistent with the terms of the Petitioner s V ORDER The Commissioner reverses PHP s final adverse determination of June 30, PHP shall provide coverage for the sleeve gastrectomy within 60 days of the date of this Order. PHP shall, within seven days of providing coverage, provide the Commissioner proof it has implemented this Order. To enforce this Order, the Petitioner may report any complaint regarding implementation to the Office of Financial and Insurance Regulation, Health Plans Division, toll free at (877) 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

6 Page 6 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 Financial and Insurance Regulation, Health Plans Division, Post Office Box 30220, Lansing, MI