FDA Proposes Rule Changes to Modernize & Improve MQSA Regulations

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The Food and Drug Administration (FDA) has set into motion the process of implementing sweeping changes to modernize and improve the current Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Proposed Rule was published in the Federal Register (Volume 84, Number 60) on March 28, 2019. Publishing of the changes in the Federal Register officially initiates a comment period that ends on June 26, 2019.  The FDA proposes adoption of any rule changes based on this proposal become effective 18 months after the date of publication of the final rule in the Federal Register.

A summary of the major provisions of the Proposed Rule outlines three categories of improvements to mammography regulations. These address changes in mammography technology; improvements that enhance enforcement of quality standards; and improvements in the way mammography results are categorized, reported, retained, and transferred to patients and healthcare providers. The improvements to these categories entail the proposal of a dozen specific additions or changes to current MQSA rules.

According to the FDA; "These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities." [1]

It should be noted adoption of these proposed rules does come at some cost to the facilities regulated by them. The FDA estimates that annually 1 percent of the total facilities regulated would close or cease to provide mammography services while adding additional burden in transferring of records to all others. That annual burden is estimated to total nearly 1.35 million hours of labor across the 8,691 MQSA certified facilities. The estimate of annualized costs over 10 years ranges from $34.96 million to $60.50 million.

Mammologix encourages its clients and all other interested parties to carefully review these proposed rules. Comments may be submitted either electronically or written under the Paperwork Reduction Act of 1995. Written/paper submissions must be submitted by April 29, 2019. Electronic comments must be submitted on or before 11:59 p.m., June 26, 2019.

[1] Mammography Quality Standards Act https://www.federalregister.gov/documents/2019/03/28/2019-05803/mammography-quality-standards-act