By Susan Harvey

Health care centers strive to provide medical care through a patient-centric model, ensuring access to quality care that considers a patient’s needs, preferences, and experiences. The approach that facilities take to implementing the U.S. Food and Drug Administration’s (FDA) updated Mammography Quality Standards Act (MQSA) requiring patient notification of breast density should be no different.

These key revisions now require clinicians to provide patients with information about their breast density while also enhancing the reporting requirements and the FDA’s auditing capabilities to ensure consistent, high-quality patient care nationally. Breast density has been a topic of interest for years and there have been many campaigns advocating for a national standard for communicating to patients about their breast density. These efforts resulted in 38 states and the District of Columbia issuing state mandates for breast density patient notification, which have now coalesced with this long-anticipated national requirement regarding breast tissue density notification from the FDA.

This national mandate provides clinicians and women the opportunity to review the importance of breast density, as both a risk factor for breast cancer and making breast tumors more difficult to find on mammographic imaging. This knowledge can be used to clarify that breast density is a nonmodifiable risk factor and can help determine the type(s) of imaging that are most beneficial for the detection of breast cancer for each woman at the time of screening. By focusing on a patient-centric approach, facilities can consider how breast density impacts their patients and how these updates will impact their daily operations – setting the stage for implementing the new MQSA breast tissue density regulations over the next 18 months.

Providing clear, understandable communication to women
Health care facilities can maintain their patient-centric focus by employing clear communication methods to meet the new MQSA breast tissue density requirements. Communication goes beyond just patient correspondence, as clinicians must also work in partnership with the entire care team, including their referring providers. Together, the patient’s radiologist, primary care physician (PCP), breast surgeon and obstetrician and gynecologist (OB/GYN) should determine the best way to work as a team to share this information. The PCP and OB/GYN can support the radiologist in delivering breast tissue density information in a way that creates action and encourages the patient to discuss it with their breast health specialist.

Radiologists can work in tandem with their referring partners when determining how to personalize care for each woman. The results of a patient’s mammogram will go in a report to the medical professional that referred her for breast cancer screening. By aligning on the best way to share information about breast density, the entire care team can ensure patients receive the facts in a clear, understandable way. Together, health care professionals can be focused on each individual patient as they implement the new breast density requirements.

Most patients are not likely to have a high degree of awareness of breast density or complex medical terms, and clinicians must keep this in mind to optimize understanding and individual care. In fact, a recent survey of women aged 40 to 76 years found few respondents perceived breast density as a risk factor. Knowing this, facilities should carefully consider which communication methods are most effective for their patient population. MQSA requires written communication, such as a letter, to share breast tissue density information with patients, but the care team must ensure any written correspondence is comprehensible and clear. Written information should be presented at a fifth-grade reading level and provide concise direction on a patient’s next steps. By simplifying communications, patients may be more likely to understand what actions to take and questions to ask.

Whether this written communication prompts women to proactively follow up with questions about their breast density or not, facilities should be prepared to address the topic verbally with patients. Facilities should consider which medical professional will be speaking with the patient and in what setting. Health centers will need to review their staff workload and operations to decide if a radiologist, technician, or other medical support personnel is best suited for the role. Radiologists spend most of their day reviewing exams while mammography technologists perform exams. Some centers may have a limited number of radiologists and technicians who can take the time to explain breast tissue density. Facilities can look at other staff who can be trained to discuss breast density with patients. Each imaging center is unique and will need to determine how its staff can incorporate these additional conversations to best inform women, optimize understanding and personalize care.

Regardless of what verbal and written method is used, the FDA and other medical experts will likely require specific language that must be shared with patients. It is critical that facilities incorporate any required verbiage while also explaining the facts about breast density in a way most patients would understand. By committing to clear communication, providers are ensuring that the patient benefits most from these breast tissue density requirements.

Understanding unique imaging center capacity
Another step to adopting the requirements in a patient-centric manner is reviewing your facilities’ capacity, as each center must determine a workflow that best serves its patient population. It is possible that breast tissue density notifications will increase supplemental imaging as more and more women understand the implications of their breast density. Health facilities must review if their imaging centers have the equipment and staffing to accommodate a potentially increased volume of supplemental exams.

Centers will also need to consider how these exams will be interpreted. Plans must be in place regarding how and when the radiologist will read these supplemental studies. There are many options such as reviewing in tandem with the patient’s screening mammographic exam, while the patient remains in the imaging center, or as a separate set of images at a different time. Additional exams also come with added billing for image acquisition and interpretation. Medical providers should work with their center’s administration team to understand billing capacity and to consider how reimbursements will impact the center. Breast imaging facilities must work to incorporate these new breast density requirements in a way that supports their workload.

Each center will need to determine how they can implement these requirements efficiently and ensure this new model of care aligns with their patient population. By reviewing the bandwidth of your health center, medical professionals can gradually make any changes over time and set themselves up to best support patients with the new MQSA requirements.

Patient considerations for accessing supplemental screening
Facilities must also consider that some patients may face barriers to accessing care and make arrangements to address these proactively. Women may not be able to take the time off work, may not have transportation, or may lack insurance coverage; all these situations will have an impact on optimal patient care. Therefore, medical professionals should be prepared to connect patients with resources to alleviate any concerns that may arise.

While the Patient Protection and Affordable Care Act (ACA) requires that most health insurers cover screening mammography with no out-of-pocket expenses for women ages 40 years or older, this full-cost coverage is not guaranteed to extend to supplemental screenings. For women with dense breast tissue, their health care providers may recommend supplementing mammography with whole breast ultrasound, contrast enhanced mammography, magnetic resonance imaging, or molecular imaging screening. Imaging centers should be prepared to discuss how supplemental exams are covered by major insurance providers and provide options for financial assistance. Providing resources and addressing costs ensures that each patient has access to the care that can best serve them.

Additionally, some patients may voice concerns about perceived risks associated with supplemental imaging, such as increased potential for false positives or radiation exposure. It is crucial that providers are prepared to answer patient questions about the risks and benefits of supplemental imaging, so that patients may make an informed decision about what is best for them individually.

Looking ahead, I am optimistic that the updated breast tissue density MQSA requirements will encourage and support the earlier detection of breast cancers that may have otherwise been masked by dense breast tissue. However, implementation of these new rules will need to be done on a center-by-center basis to ensure that their patient population is best supported throughout the transition. By reviewing a facility’s specific needs, communicating efficiently, and considering any barriers to screenings, care teams can continue to offer patient-centric care.

About the author: Dr. Susan Harvey is currently the Vice President of Corporate Global Medical Affairs at Hologic, a medical technology innovator focused primarily on women’s health. She joined the organization in April 2019, and her current goal is to help elevate women’s health and wellbeing worldwide. That includes her leadership role with the Hologic Global Women’s Health Index, the most comprehensive survey – conducted in partnership with Gallup – about women’s health. The Index provides a science-backed, data-driven roadmap for countries to improve the wellbeing of women and girls.