On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.”  The proposed changes to mammography facility regulations would be the first issued in more than 20 years.  The FDA believes the change will “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making.”  In addition, FDA is proposing to modernize quality standards by, for example, expressly authorizing FDA communications with patients and practitioners in the event of quality issues, requiring use of FDA-approved or -cleared digital accessories, and strengthening recordkeeping requirements.  These changes not only enhance regulatory requirements, but likely foreshadow increasing enforcement and communications from FDA with regard to mammography services.

As a general rule, it is a well settled rule of law that FDA does not regulate the practice of medicine, but mammography services are a notable exception.  Congress provided the FDA with regulatory oversight of mammography facilities in 1992 following passage of the Mammography Quality Standards Act (MQSA). The MQSA entrusts FDA with facility accreditation, annual inspections, certification, and enforcement of standards to assist in ensuring such facilities provide quality care.  FDA Commissioner Scott Gottlieb remarked that the new rule proposal would “modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting.”

Under the proposed rule, mammography providers would be required to tell women whether they have dense breast tissue, which may increase cancer risk and mask tumors, making cancer detection more challenging.  Women with dense tissue are often advised to seek other screening tests along with mammograms, such as M.R.I. scans or ultrasound, but in many states this is left to the discretion of providers.  (Currently, there are roughly 36 states already requiring that female patients be given information about breast density).  The new rule proposes specific language that would be implemented nationwide to explain breast density, note that some women may need additional imaging tests and recommend patients consult their physicians regarding their results.  The FDA language would set a minimal standard, and will not preempt states from imposing additional requirements regarding disclosures.

The content of communications beyond basic diagnosis have been raised as a concern under current state law disclosure standards. Some within the medical profession have argued that disclosure laws could provide women with information that does not necessarily reflect their condition, and could lead to a demand for expensive, unnecessary tests.  Further, some physicians have also suggested that state-mandated letters may be too complex for patients to understand.  For instance, the Journal of the American Medical Association (JAMA) published a study analyzing notification letters sent out in over 20 states and found that “many use such complex language that patients need a college degree to understand them.”  Acknowledging the pushback, Commissioner Gottlieb stated that women had a right to receive such information regarding their health in order to make an informed decision about next steps.

Moving forward, entities and medical professionals should be mindful of these regulations when providing mammography services to female patients.  It will be important to exercise best medical judgment when examining mammogram results as dense breast tissue may represent a significant confounder when assessing breast cancer risk.  Communications on these topics could face additional scrutiny as medical practitioners try to balance obligations in regulations with general principles about informing patients about their condition in an understandable manner.  In addition, there is potential that changes could drive an increase the use of additional diagnostic testing.  Thus, there is some uncertainty as to whether there should be a push for enhanced screening.

EBG will continue to monitor this proposed rule.  The FDA is accepting comments on these proposed changes until June 26, 2019.  The notice and comment portal for submitting comments is available at https://www.regulations.gov/document?D=FDA-2013-N-0134-0006.

Brian Hedgeman