HFA summarizes mammogram machine deregulation and slightly reduced fees of Senate Bill 136, which become Public Act 63 of 2025.

https://legislature.mi.gov/documents/2025-2026/billanalysis/House/pdf/2025-HLA-0136-MRYXBQ50.pdf

Senate Bill 136 amends the Public Health Code to eliminate certain existing statutory requirements for the use of radiation machines for mammography and to require the Department of Labor and Economic Opportunity (LEO) to develop and issue rules to provide those standards and requirements. The bill also eliminates a requirement that a patient be notified of a mammogram showing dense breast tissue and provisions requiring the governor to appoint a radiation advisory board.

The code has several provisions related to the use of radiation machines for mammography. Generally speaking, they currently require radiation machines used for mammography to be registered with LEO and specifically authorized for use for mammography; provide standards
a radiation machine, facility, and personnel must meet to be authorized; require inspection and certification of the machines at least annually; and allow LEO to issue rules to implement those provisions.

The bill retains the registration requirements described above, but removes the authorization and annual inspection provisions, as well as the prescribed standards, and instead requires LEO to issue standards for those machines, facilities, and personnel by rule. To ensure compliance,
LEO must inspect radiation machines at intervals it considers necessary or appropriate, including follow-up inspections of machines found to be out of compliance. In developing its rules, LEO must do both of the following:

• Incorporate by reference the standards it determines apply to mammography, including those under the federal Mammography Quality Standards Act of 1992 and its rules that exist when the bill takes effect. If those standards are revised after the bill is enacted, LEO must develop rules to incorporate the revision by reference.

• Specify in the rules the minimum training and performance standards for an individual using a radiation machine for mammography.

The bill removes fees related to compliance evaluations for non-accredited radiation machines used for mammography, and it changes other fees to their inflation-adjusted amounts for fiscal year 2024-25, as shown in the table below. Beginning October 1, 2026, these fee amounts will be adjusted for annual inflation based on the Consumer Price Index (CPI) for the Detroit Warren-Dearborn area.

Finally, the bill repeals sections 13524 and 13531 of the code. Section 13524 now requires patient notification of a mammogram demonstrating dense breast tissue.3 Section 13531 now requires the appointment of a radiation advisory board.

The bill takes effect March 24, 2026.

Unspoken in the HFA analysis are two instructive facts.

After countless trees, days of patient anxiety, and hours of clinical follow-up were expended in its wake, this bill ends 11 years of Michigan law requiring "dense breast tissue" reports. 

Yet it began with legislative high hopes for "protecting women" and probably even "reducing breast cancer." 

Note the rigid standard set by the law and spelled out in state regulation.

https://www.michigan.gov/leo/bureaus-agencies/miosha/divisions/technical-services-division/rad-safety/mammography/breast-density-patient-notification-requirement

Public Act 517 of 2014 was signed into law on January 10, 2015 and will be effective on June 1, 2015. The Act requires mammography facilities to provide certain information to a patient whose mammogram demonstrates heterogeneously dense or extremely dense breast tissue. The information must be in the written lay summary to the patient and include the following information:

"Your mammogram shows that your breast tissue is dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer through a mammogram. Also, dense breast tissue may increase your risk for breast cancer. This information about the result of your mammogram is given to you to raise your awareness. Use this information to discuss with your health care provider whether other supplemental tests in addition to your mammogram may be appropriate for you, based on your individual risk. A report of your results was sent to your ordering physician. If you are self-referred, a report of your results was sent to you in addition to this summary."

Beginning with mammography inspections performed on or after June 1, 2015, section inspectors will ask to see evidence of compliance with this requirement.

Discussion
Public Act 517 of 2014 requires that mammography providers give the above notification to patients that have been determined by the interpreting physician as having dense breasts. The paragraph above will need to be included in the lay summary of the mammography results. This summary is currently required to be sent to the patient by Rule 657 of the Ionizing Radiation Rules which adopts the Mammography Quality Standards Act (MQSA) (42 USC 263b) regulation for medical records and mammography reports. The information about dense breast tissue must be quoted verbatim.

Any time a lay summary is provided to a patient with dense breasts, it will need to include the dense breast notification required by Act 517. The Radiation Safety Section's enforcement of the lay summary requirement will adhere to guidance issued by the FDA.

The requirements of Act 517 do not apply to radiography of the breast performed during invasive interventions for localization or biopsy procedures.

Updated March 24, 2015

This is the very opposite of individual healthcare.

However, it gets worse. Before freedom fans rejoice too gleefully at Michigan's regulatory cut, check out what the feds did in the interim.

https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program/important-information-final-rule-amend-mammography-quality-standards-act-mqsa

Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)

The FDA issued a final rule on March 10, 2023, to amend the MQSA regulations (“2023 MQSA Final Rule”). Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024. Facilities subject to the MQSA, must now comply with all applicable requirements, including the breast density notification.

Access the 2023 MQSA Final Rule in its entirety at Federal Register: Mammography Quality Standards Act.

MQSA Inspections

During a facility’s annual MQSA inspection, inspectors will review documentation that relates to whether the facility is meeting the requirements of the MQSA. As of September 10, 2024, the MQSA regulations have certain additional requirements, including:

Mammography Reports

Name and location of the facility performing the exam, (at a minimum the city, State, ZIP code, and telephone number).
An overall final assessment of findings, classified into one of the following categories:

Negative
Benign
Probably Benign
Suspicious
Highly Suggestive of Malignancy
Known Biopsy-Proven Malignancy

Post-Procedure Mammogram for Marker Placement.

In cases where no final assessment category can be assigned due to incomplete work-up, the report should indicate:
Incomplete: Need additional imaging evaluation
Incomplete: Need prior mammograms for comparison.
An overall assessment of breast density, classified in one of the following categories:
"The breasts are almost entirely fatty."
"There are scattered areas of fibroglandular density."
"The breasts are heterogeneously dense, which may obscure small masses."
"The breasts are extremely dense, which lowers the sensitivity of mammography."

Patient Lay Summaries

The patient's name, and the name, address, and telephone number of the facility performing the exam.
Depending on whether the patient's breast density is dense or not dense, as indicated by the mammography report, the patient lay summary must include one of the following notification statements:
Not dense: "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."
Dense: "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."

Communication of Results

When the exam has a final assessment category of "Suspicious" or "Highly Suggestive of Malignancy," the mammography report is provided to the health care provider and the patient lay summary is provided to the patient within 7 calendar days of the date the mammogram was interpreted. When the exam has an assessment of "Incomplete: Need prior mammograms for comparison," the facility issued a follow-up report with a final overall assessment within 30 calendar days of the initial report, regardless of whether comparison views are obtained.

Medical Outcomes Audit

The annual medical outcomes audit includes the positive predictive value, cancer detection rate, and recall rate for each interpreting physician as well as for the facility as a whole.

Additional Information About the MQSA Final Rule

This information is not an exhaustive list of everything contained in the 2023 MQSA Final Rule. As always, facilities are required to comply with all mammography requirements applicable to them under the MQSA and its implementing regulations. Below is an overview and/or excerpts of some of the additional requirements of the 2023 MQSA Final Rule. It is important to note that the FDA may take enforcement action for noncompliance with the MQSA regulations, whether observed during an annual inspection or determined by other means.

Accreditation Failures

If a facility has failed to become accredited after three consecutive attempts, no accreditation body must accept an application for accreditation from the facility for a period of 1 year from the date of the most recent accreditation failure.

(21 CFR 900.4(a)(6)(ii))

Equipment

All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use. (21 CFR 900.12(b)(2)(i))

Personnel Records

To comply, facilities must:

Maintain records of training and experience
Ensure records are relevant to their qualification under MQSA
Include records for personnel working or who have worked at the facility as:
Interpreting physicians
Radiologic technologists
Medical physicists
Records must be available for review by MQSA inspectors.

Records of personnel no longer employed by the facility must be maintained for no less than 24 months from the date of the departure of the employee, and these records must be available for review at the time of any annual inspection occurring during those 24 months.

The facility must provide copies of these personnel records to current interpreting physicians, radiologic technologists, and medical physicists upon their request.

Facilities must provide personnel records to former employees if the former employees communicate their request within 24 months of the date of their departure.

(21 CFR 900.12(a)(4))

Recordkeeping

Facilities must maintain the original mammograms and mammography reports in a permanent medical record of the patient for the longest of the following:

a period of not less than 5 years,
a period of not less than 10 years if no additional mammograms of the patient are performed at the facility, or
a period, if longer, mandated by State or local law.
Facilities must implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained in retrievable form in the mammographic modality in which they were produced. They cannot be produced by copying or digitizing hardcopy originals.

(21 CFR 900.12I(4)(i))

Transfer of Records or Release of Copies

Transfers of mammograms and mammography reports, or release of copies, must take place within 15 calendar days of the facility receiving the request. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred or released for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically. Additionally, before a facility closes or ceases to provide mammography services, it must make arrangements for access by patients and healthcare providers to their mammographic records. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.

(21 CFR 900.12(c)(4)(ii), (iii), (v))

Facility Responsibility to Self-Referred Patients

Each facility that accepts patients who do not have a healthcare provider must maintain a system for referring such patients to a healthcare provider when clinically indicated, which must include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy.

(21 CFR 900.12(c)(2)(ii))

That's right! Even more standardized language is in place for the entire country. 

Forget facility competition for excellence. We're farther than ever from individual, relationship-based care.