FDA Proposes Updates to the Mammography Quality Standards Act

By Adrienne Dresevic, Esq. and Arturo Trafny, Esq. of The Health Law Partners, P.C.

On March 28, 2019, the Food and Drug Administration (FDA), proposed an update to the Mammography Quality Standards Act of 1992 (MQSA), aimed at modernizing the regulations by incorporating current standards and practices. The proposal may be accessed here. The FDA believes such updates will improve the delivery of mammography services by implementing: (1) improvements addressing the changes to mammography technology; (2) improvements to enhance the enforcement of MQSA standards; and (3) improvements to how mammography results are categorized, reported, retained, and transferred to patients and providers.

The proposal would implement the following updates:

Require mammograms to be presented in the mammographic modality they are produced in, prohibiting facilities from submitting copied or digitized clinical images to referring physicians;
Prohibit an accreditation body from accepting applications from facilities that have failed to become accredited after 3 consecutive attempts, until 1 year after most recent failure;
Expressly state a facility’s certificate may be suspended/revoked due to a failure to comply with reasonable requests from the FDA, State certification agency, or accreditation body for records;
Permit the State certification agency to initiate an additional mammography review (AMR), and expressly permit the FDA and State certification agency to notify patients and providers when a facility is unable/unwilling to perform required patient and referring physician notification;
Require a closing facility, or a facility that will no longer provide mammography services, to make arrangements for patient and provider access to mammography reports/images;
Require facilities to provide personnel with copies of their MQSA qualification records;
Require mammographic exam reports to include facility name and location;
Change language in the “benign” final assessment category and add 3 new categories of assessment for: a known malignancy, post-procedure mammogram for marker placement, and an incomplete assessment requiring review of previous screenings;
Require facilities to provide mammography results to patients and providers within 7 days after a final interpretation, if the report is “suspicious” or “highly suggestive of malignancy”, but no later than 14 calendar days from the examination date in any case;
Require a summary, written in lay language, to be sent to patients specifying whether the mammograms are “suspicious” or “highly suggestive of malignancy”;
Require reports to patients and providers to include an assessment of breast density;
Require each facility to implement policies and procedures to minimize the loss of mammography images/reports; and
Clarify the minimum information a facility must collect during the mammography medical outcomes audit.

While the proposal seeks to update the MQSA in multiple aspects, one important update would be to the information and language a patient receives following a mammogram. The proposal would require correspondence following such an examination to specifically indicate whether a patient has dense breasts or not. Specifically, the proposal establishes four categories: (1) the breasts are almost entirely fatty; (2) there are scattered areas of fibroglandular density; (3) the breasts are heterogeneously dense; and (4) the breasts are extremely dense, which lowers the sensitivity of mammography. Further, the FDA groups these categories into two broader categories, either high or low density. The lay summary provided to patients would specify whether their breasts have high or low density.

Presently, language required under state law for such patient letters is not always as informative. Many state laws do not require radiologists’ mammography letters to specifically inform a patient whether she has dense breasts or not. For instance, Connecticut law requires the following notice regarding breast density:

“If your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests . . . A report of your mammography results, which contains information about your breast density, has been sent to your physician’s office and you should contact your physician if you have any questions or concerns about this report.”

As noted by the FDA, dense breast tissue increases the risk of developing breast cancer and can obscure mammographic signs of breast cancer, resulting in delayed cancer diagnoses. By providing patients with this vital information, they are more equipped to make informed healthcare decisions and may seek additional screenings with more effective equipment for evaluating dense breasts. Thus, this information could lead to earlier detection of breast cancer.

Ultimately, the FDA believes these updates will reduce mortality rates and breast cancer treatment costs nationwide. The FDA estimates annualized benefits ranging from $16.27 million to as high as $534 million over a ten-year period. The comment period for the proposal ended on June 26, 2019. The proposed effective date for the proposal is 18 months following the date of publication of the final rule.

Conclusion

Radiology providers and suppliers should stay tuned for a Final Rule from the FDA. We will provide a follow-up article regarding implemented updates to the MQSA upon the issuance of a Final Rule.

For more information on issues relating to this article, please contact Adrienne Dresevic, Esq. at (248) 996-8510 or by email at adresevic@thehlp.com.

Adrienne Dresevic, Esq, is a founding shareholder of The Health Law Partners, PC, a nationally recognized healthcare law firm with offices in Michigan and New York. Practicing in all areas of healthcare law, she devotes a substantial portion of her practice to providing clients with counsel and analysis regarding compliance, Stark Law, Anti-Kickback Statute, and compliance related issues. Ms. Dresevic is a member of the American Bar Association Health Law Section’s Council, which serves as the voice of the national health law bar within the ABA. Ms. Dresevic is the Section’s Budget Officer. She also served as the ABA Health Law Section’s Co-Chair of the Physicians Legal Issues Conference Committee. She is licensed to practice law in Michigan and New York, and can be contacted at adresevic@thehlp.com.

Arturo Trafny, Esq, is an associate attorney at the Health Law Partners, P.C. Mr. Trafny graduated from Chicago-Kent College of Law. Practicing healthcare law, Mr. Trafny concentrates on regulatory and transactional matters.

The authors are members of The Health Law Partners, PC and may be reached at (248) 996-8510 or (212) 734-0128, or at www.thehlp.com.