FDA Proposes Policy Changes to Mammography Regulations

According to the National Cancer Institute, in 2018 an estimated 266,000 women were diagnosed with breast cancer, and nearly 41,000 women died from the disease. Now the U.S. Food and Drug Administration (FDA) has proposed amending current mammography regulations issued under the Mammography Quality Standards Act of 1992 (MQSA).

Most of today’s mammography regulations are at least 20 years old, and the FDA believed it was time to modernize its guidelines and ensure that new policies reflect major developments in breast health over the past several decades. Among those developments are technological advances such as 3D breast tomosyntheses for screening.

The FDA wants to usher in a new era of improved quality, best practices, and open communication to help patients understand the disease and its treatment and to become more involved in the choices surrounding their healthcare.

Three areas of improvement

The FDA is recommending improvements to three areas of mammography regulations that focus on changes in technological innovations, quality measures, and the way mammography results are handled, including functions such as categorization and reporting. Among other reporting updates, the planned changes would require that the patient’s lay summary categorize the breasts as low or high density. One of four categories of breast density would be included in the patient’s report to the referring healthcare provider.

Cancer.gov. (2018, September 7). Retrieved April 2, 2019, from https://www.cancer.gov/types/breast/breast-changes/dense-breasts.

Advantages and costs of proposed changes

The proposed standards could potentially increase early breast cancer detection, improve treatment and death rates, and lower cancer treatment costs. According to the FDA, the estimate of annualized benefits over 10 years ranges from $16.27 million on the low end to $534.03 million on the high end. The estimated annualized costs to mammography facilities are in the range of $33.86 million to $60.50 million.

The deadline for public comments on the proposed policy changes is June 26, 2019. The effective date for any changes would be 18 months after the date of publication of the final rule in the Federal Register.

Julie Johnson, Analyst

Prior to joining MD Buyline in 2008, Julie Johnson worked in account management, accounting, and financial planning.

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