The Honorable Todd Young
U.S. House of Representatives
Washington, DC 20515
Subject: Removing Barriers to Clinical Research Act
Dear Representative Young,
On behalf of the American Association of Neurological Surgeons (AANS) and Congress of Neurological
Surgeons (CNS), we are pleased to endorse your bill, the “Removing Barriers to Clinical Research Act.”
America has a long tradition of excellence and innovation in patient care, and neurosurgeons have been on
the cutting edge of these advancements. However, for a number of reasons, American medical innovation
is at serious risk and Congress must take the necessary steps to remove inappropriate regulatory burdens
on medical device innovation, which hurt America’s competitive advantage in healthcare advancements,
and delay or deny appropriate care for patients.
Your legislation is an important step that will help pave the way for patients to have access to new and
innovative life-saving technologies. Organized neurosurgery has long advocated that Medicare cover the
medical costs of Medicare patients participating in FDA-approved clinical trials. Given that Medicare
already covers medical expenses related to drug trials approved by the FDA, it is certainly appropriate to
provide the same benefit to patients involved in medical device clinical trials; thus eliminating the
requirement for separate Medicare approvals of trials that the FDA has already determined are scientifically
sound and have appropriate protections for patients.
Removing this bureaucratic barrier should help lower the lower the costs and time associated with
conducting clinical trials and provide Medicare patients the opportunity to participate in research that could
lead to life-saving surgical treatment of nervous system disorders such as stroke, degenerative spine
disorders, Parkinson’s and Alzheimer’s disease.
Thank you for your leadership on this issue. The AANS and CNS stand ready to help advance your
legislation.
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