April 14, 2015 The Honorable Robert P. Casey, Jr. United States

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.
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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
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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