By Richard Frank, MD,
As I stated in the first installment of this blog, the
language contained in breast
density notification letters is inconsistent among the 12 states that have
passed notification legislation.
To ensure that all women with dense breast tissue are
adequately informed of their status, risk factors, and screening options, the Food
and Drug Administration (FDA) has proposed amending regulations issued under
the Mammography Quality Standards Act (MQSA) to address breast-density
reporting. This Breast Density Reporting amendment is scheduled to be
issued as a Notice of Proposed Rulemaking in December 2013.
It’s fitting that such reform should come from the MSQA,
which ensures that all women in this country have access to quality mammography
for breast cancer detection at its earliest, most treatable stages. Prior to
the MQSA, wide variability existed across the U.S. in terms of screening
mammography: A woman in one breast clinic might receive a level of screening
that was quite different from what she could have experienced in a neighboring
state. When it became law in October of 1992, the MQSA required the Department
of Health and Human Services (HHS) to develop standards for enforcement through
strict accreditation, certification, and inspection of equipment and personnel
at mammography facilities.
In 2013, discussion has shifted from mammogram quality to
variability regarding levels of patient inform. Clearly, the need for common
quality standards that fueled passage of the MQSA 21 years ago exists now with
respect to breast-density reporting.
Skeptics of breast density-inform legislation worry that
these letters will increase the volume of supplemental
screening in the form of ultrasounds and MRIs, leading to higher health
care costs. But we know that earlier detection of
breast cancer not only leads to increased efficacy—including the
preservation of breast anatomy—but also a lower cost over the duration of
patient treatment. Quite simply, breast cancers caught sooner are treated more
effectively and less expensively.
Furthermore, this question of overutilization is tempered by
the normal practice of medicine. When a dense-breasted woman is notified via an
inform letter that she is at particular risk and that she has screening
options available to her, she will consult her physician and ask for
advice. That’s the whole idea behind patient-centric health care: informed patients
discussing their medical needs with their caregivers before making informed and
Professional Biography: Richard Frank, MD,
PhD, is chief medical officer (CMO) at Siemens Healthcare. He has 30 years of
experience in regulatory, labeling, public and private payment, and clinical
adoption of therapeutic and diagnostic drugs and medical devices. Dr. Frank
trained in internal medicine at Strong Memorial Hospital in Rochester, N.Y.,
earning licensure in the State of New York to practice medicine and surgery. He
holds a PhD in pharmacology from the University of Tennessee-Memphis.
Additionally, he holds two bachelor-of-arts degrees in chemistry and biology
(honors), with a minor in mathematics, and was elected to Phi Beta Kappa at
Cornell College in Mount Vernon, Iowa.