April 14, 2015 The Honorable Robert P. Casey, Jr. United States Senate 393 Russell Senate Office Building Washington, D.C. 20510 Dear Senator Casey: Thank you for your letter regarding the use of power morcellators in the treatment of uterine fibroids. As you know, decisions around whether and how to treat medical conditions are made by practicing physicians and their patients. The role of health plans is to make coverage available that encourages and supports safe, effective care. In this letter, we describe how health plans around the country are evaluating and making coverage decisions with respect to the use of power morcellators. In addition, given the relevancy to the implicit safety questions you posed, we note the serious gaps in the current approval and post monitoring process for medical devices and where regulatory changes could result in significant improvements to patient safety. Actions by regulatory agencies, professional medical society guidelines, and clinical peer-reviewed studies all play critical roles in influencing provider practice, patient treatment options, and insurance coverage decisions. Notably, the U.S. Food and Drug Administration (FDA)’s updated Safety Communication issued in November 2014 warned against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of fibroids. The FDA urged health care providers and patients to carefully consider alternative treatment options and strongly recommended that manufacturers include information on their product labels acknowledging that power morcellators may be indicated for only a limited population of patients, given the risks of spreading unsuspected cancer. April 14, 2015 Page 2 The leading professional society for obstetrics and gynecology, the American College of Obstetricians and Gynecologists (ACOG), has affirmed that, while power morcellation may still be appropriate for some women, the FDA’s new contraindications and recommendations for providers and patients will help protect women from potentially harmful outcomes. We believe there is a critical need for professional societies, such as ACOG, to provide more definitive guidance on the use of power morcellators for the treatment of uterine fibroids. Lack of guidance specificity can result in uncertainty and variation in practice while greater clarity will help physicians and patients make more informed decisions, protect women from unnecessary risks, and inform plan coverage policies. Because of the close relationship between professional society guidelines and health plan coverage decisions, our community has reached out to the Executive Leadership at ACOG to encourage that greater clarity be provided for clinicians regarding the use of these devices. Health plans give significant weight to the recommendations of leading medical societies with respect to coverage decisions. At the same time, with more scientific evidence in the public domain, some plans have modified their coverage policies to provide an opportunity for additional dialogue with physicians about alternative treatment options. Health plans also actively disseminate safety information to their clinicians as part of their ongoing efforts to provide access to safe, effective care. Our chief medical officers report that there has been a major reduction in the use of laparoscopic power morcellators in today’s market. The action of the FDA, the comments by ACOG, and the steps taken by health plans have contributed to the decline in use of power morcellators. At the same time, the experience with power morcellators also shines a spotlight on gaps in the device safety infrastructure and the critical need to strengthen the pre-and post-market review and approval process. Currently, a majority of devices regulated by the FDA receive market approval through a less stringent device approval system known as the 510(k) process. Power morcellators received approval in this fashion where the device manufacturer needed only to demonstrate that a device is “substantially equivalent” to a device already on the market rather than conduct studies to assess the safety and effectiveness of that specific device. As Congress continues to explore ways to promote biomedical innovation, we urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators. Requiring post-marketing review will greatly improve our ability to identify adverse events and to act more April 14, 2015 Page 3 rapidly when safety issues are identified. Had this been required for morcellators, safety issues would have been identified much sooner. As part of the process to improve safety, we have urged the acceleration of the unique device identification (UDI) system, which will enable providers to have key device information on hand at the point of care. UDI integration into clinical data sources, like device-specific registries and EHRs, is a key part of the FDA’s vision for a national medical device surveillance system – a vision that a number of our member health plans actively participated in developing. Expanding UDI use would also complement the FDA’s Safety Sentinel project in which our member plans have been integrally involved. We look forward to working with you on patient safety issues and to promote a pre- and post-market biomedical infrastructure that better balances manufacturer’s innovation and patient access to safe and effective products, procedures and treatments. Sincerely, Karen Ignagni President and CEO