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SB 136

Relating to developmental disabilities services providers.

2025 Regular Session

Michigan shifts mammography regulation from detailed statutes to LEO rulemaking aligned with MQSA, repealing dense-breast notification and updating training, inspections, and fees.

Effective date, January 1, 2026.
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Bill Summary · SB 136

SB 136 — Summary (Michigan, introduced Jan 23, 2025)

Subject: Public Health Code — radiation machines for mammography; dense‑breast notification; rulemaking and fees

Main purpose

The bill modernizes Michigan’s statutory framework for mammography by removing many prescriptive statutory requirements and instead directing the Department of Labor and Economic Opportunity (LEO) to adopt rules governing the use, inspection, training, and performance standards for radiation machines used for mammography. It also (1) repeals the state statute that required providers to notify patients when mammograms demonstrate dense breast tissue and (2) repeals the statutory Radiation Advisory Board. The changes are intended to align state requirements with the federal Mammography Quality Standards Act (MQSA) and the FDA’s recent MQSA updates.

Key provisions and changes

  • Replaces detailed statutory mammography authorization provisions with a rulemaking mandate:

    • Eliminates the statutory authorization/certificate framework and detailed statutory standards for equipment, facility consultation, and personnel.
    • Requires LEO to promulgate rules that set out requirements for radiation machines, facilities, and personnel authorized to perform mammography.
    • Rules must incorporate, by reference, applicable MQSA standards and any MQSA revisions in effect on the bill’s effective date (and provide for incorporation of future MQSA revisions).
    • Rules must specify minimum training and performance standards for individuals operating radiation machines for mammography (including mammography interpreters).

  • Inspections and compliance:

    • LEO must inspect radiation machines at intervals the Department deems necessary, and may perform follow‑up inspections for noncompliance.
    • LEO may accept written certifications of correction in lieu of some follow‑up inspections.

  • Fee adjustments:

    • Increases registration/renewal and inspection fees (examples in bill text):
    • First veterinary/dental x‑ray tube: $104.88 → $108.45 (annual)
    • Each additional veterinary/dental tube: $58.19 → $60.17 (annual)
    • Non‑veterinary/non‑dental tube: $174.88 → $180.83 (annual)
    • Follow‑up inspection due to noncompliance: $233.23 → $241.26
    • Other mammography‑related evaluation/reinspection fees in the bill text are adjusted (see bill for full fee schedule).

  • Repeals:

    • Section 13524 (statutory dense‑breast notification requirements) — removes the specific state notice requirement to patients when mammograms show dense breast tissue.
    • Section 13531 (establishment of Radiation Advisory Board).

Who is affected

  • Mammography facilities and imaging centers — regulation shifts from rigid statutory requirements to LEO rulemaking; may require operational adjustments to meet new rules and slightly higher state fees.
  • Radiologic technologists / mammography operators and interpreting physicians — subject to LEO’s new training and performance standards.
  • Patients — dense breast notification requirement currently in state statute would be repealed; patient notification practices will be governed by the MQSA federal standard (incorporated by LEO rule).
  • LEO (Radiation Safety Section) — gains primary rulemaking and inspection authority for mammography standards formerly detailed in statute.

Policy rationale and fiscal impact

  • Rationale: the committee analysis cites the FDA’s MQSA updates (federal rule changes in 2024) and states the bill is intended to align Michigan’s requirements with updated federal standards.
  • Fiscal impact: committee/fiscal staff report indicates no state or local fiscal impact (administration and rule implementation expected to be handled within existing resources), aside from fee changes that affect regulated entities.

Procedural / timeline notes

  • Introduced Jan 23, 2025; referred to the Senate Committee on Health Policy.
  • If enacted, the timing and practical effect of many changes will depend on LEO’s subsequent rulemaking (publication of proposed rules, public comment, final rules) and the timing of incorporation of MQSA revisions.
  • Stakeholders should monitor LEO rulemaking dockets for proposed standards and inspection schedules, and for the final fee schedule.

What to watch for

  • Proposed rule text from LEO (training requirements, performance metrics, inspection frequency).
  • How patient notification language under federal MQSA will be implemented in state rules given repeal of the state statute.
  • Regulatory compliance timelines and any transition provisions for existing mammography authorizations and facilities.

Compiled from official sources — confirm details with the bill’s official record.

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