Mammography Quality Standards Act rule (2024)
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The Mammography Quality Standards Act is a significant rule issued by the Food and Drug Administration (FDA) effective September 10, 2024, that will update mammography regulations according to current science and best practices by modernizing the Mammography Quality Standards Act of 1992 (MQSA), pursuant to the Public Health Service and the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C).[1]
Timeline
The following timeline details key rulemaking activity:
- September 10, 2024: The final rule will take effect.[1]
- March 10, 2023: The FDA issued the final rule.[1]
- June 26, 2019: The comment period closed.[1]
- March 28, 2019: The FDA issued the proposed rule and opened the comment period.[1]
Background
For women in America, the CDC identified breast cancer as the second leading cause of cancer deaths following lung cancer, disproportionately affecting Black and non-Hispanic women. The FDA suspected potentially avoidable breast cancer mortality rates after the Government Accountability Office said that mammography can be the hardest type of radiographic images to read, increasing the chances of false-negative mammogram results. Since the 1992 Mammography Quality Standards Act, both technology and the science of reading mammography have improved, so the FDA issued the Mammography Quality Standards rule to increase the efficacy of mammography in light of the new information and research. It will take effect on September 10, 2024.[1]
Summary of the rule
The following is a summary of the rule from the rule's entry in the Federal Register:
| " | The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to 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][2] | ” |
Summary of provisions
The following is a summary of the provisions from the rule's entry in the Federal Register:
| " |
FDA is making three categories of improvements to our mammography regulations: improvements that 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. Specifically, in this final rule FDA is making the following amendments: New and amended provisions related to technology that, among other things, update several equipment and quality control provisions in the regulations to address current technology, including digital mammography; Improvements that enhance enforcement that, among other things: ○ Require that mammograms submitted for interpretation be presented in the mammographic modality in which they were originally produced, and not be copied or digitized from hardcopy original images, which could adversely affect the accuracy of interpretation; ○ Prohibit accreditation bodies from accepting an application for accreditation from a facility that has failed to become accredited after three consecutive attempts until 1 year after the most recent accreditation failure; ○ Expressly state that a facility's certificate may be suspended or revoked due to a failure to comply with requests by FDA, the State certification agency, or the AB for records, including clinical images for an additional mammography review (AMR), or with requests by current or former facility personnel for records documenting their qualifications; ○ Add the State certification agency as an entity that may initiate an AMR, which can help detect quality issues, and also to state expressly that FDA and the State certification agency can notify patients and their providers individually or through the mass media when a facility is unable or unwilling to perform a required patient and referring physician notification (PPN), which would help to ensure that patients and providers are informed of serious risks to human health resulting from mammography that fails to meet quality standards; ○ Require that, before a facility closes or no longer provides mammography services, it must make arrangements for access by patients and healthcare providers to mammography images and reports; and ○ Require facilities to provide personnel with copies of their MQSA qualification records, which are often needed to work at additional or new facilities. Improvements in the way mammography results are categorized, reported, retained, and transferred to patients and healthcare providers that, among other things: ○ Require that the mammographic examination report include the facility name and location (at a minimum, the city, State, ZIP code, and telephone number of the facility), in order to help to ensure that healthcare providers can obtain the necessary information to enable them to assist patients in making informed healthcare decisions; ○ Change the explanatory language in one final assessment category (“Benign”) to promote greater consistency and accuracy in the use of the category, and add three new categories of mammographic assessment to the existing categories in the regulations, which will allow mammography facilities to precisely classify and communicate findings; ○ Add a specific, required timeframe for facilities to send mammography reports to healthcare providers and the summary written in lay terms to patients whose mammograms have either “Suspicious” or “Highly Suggestive of Malignancy” final assessment categories, which could lead to earlier definitive tissue diagnosis of malignancy and earlier start of treatment, and avoid, for the patient, the anxiety of a protracted waiting period; ○ Require reporting to patients and healthcare providers to include an assessment of breast density, in order to provide them with additional information about their mammography and the potential limitations of their mammogram results so that patients and their healthcare providers can make informed healthcare decisions by; Retaining the two categories of density in the patient lay summary, but changing the wording from the comparative terms “high density” and “low density” to “dense” and “not dense,” in order to align with clinical practice and improve clarity to the patient. Revising the written lay summary of the results provided to the patient to contain one of the following breast density notification statements. The non-dense breast notification (see § 900.12(c)(2)(iii) in this final rule) now states, “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” The dense breast notification (see § 900.12(c)(2)(iv) in this final rule) now states, “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” Requiring that the written report of the results of the mammographic examination provided to the healthcare provider include information concerning an overall assessment of breast density, classified in one of the following categories: (A) “The breasts are almost entirely fatty.” (B) “There are scattered areas of fibroglandular density.” (C) “The breasts are heterogeneously dense, which may obscure small masses.” (D) “The breasts are extremely dense, which lowers the sensitivity of mammography.” ○ Require each mammography facility to implement policies and procedures to minimize the loss of mammography images and reports because the loss of these records can have a significant, negative impact on clinical care, and also specify the timeframe within which facilities must transfer original mammograms and copies of reports to patients, healthcare providers, and others because delays in the transfer of these records can lead to delays in diagnosis or treatment; and ○ Clarify the minimum information that facilities must collect during the mammography medical outcomes audit because calculating and tracking these values is important to the evaluation of accuracy in detecting breast cancer, allowing facilities and interpreting physicians to review their performance and enact quality improvement measures.[1][2] |
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Significant impact
- See also: Significant regulatory action
Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.
Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]
The text of the Mammography Quality Standards Act states that OMB deemed this rule significant, but not economically significant:
| " | The Office of Information and Regulatory Affairs has determined that this final rule is a significant regulatory action as defined by Executive Order 12866.[1][2] | ” |
Text of the rule
The full text of the rule is available below:[1]
See also
- REINS Act
- Significant rule
- Food and Drug Administration
- Federal Food, Drug, and Cosmetic Act of 1938
External links
Footnotes
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