SB 164 — Mammography

FloridaDOCUMENT SenateUNAVAILABLE - 2018 CS for SB 164 By the Committee on Health Policy;

and Senator Grimsley 588-02377-18 2018164c1 A bill to be entitled An act relating to mammography;

amending s.

404.031, F.S.;

defining the term “mammography”;

amending s.

404.22, F.S.;

conforming a change made by the act;

creating s.

402.221, F.S.;

requiring facilities performing mammography to include certain information in a summary of the mammography report which must be provided to each patient;

providing applicability;

providing for future repeal;

providing an effective date.

12 Be It Enacted by the Legislature of the State of Florida:

14 Section 1. Present subsections (10) through (20) of section 404.031, Florida Statutes, are redesignated as subsections (11) through (21), respectively, and a new subsection (10) is added to that section, to read:

404.031 Definitions.—As used in this chapter, unless the context clearly indicates otherwise, the term:

(10) “Mammography” means radiography of the breast for the purpose of enabling a physician to determine the presence, size, location, and extent of cancerous or potentially cancerous tissue in the breast.

Section 2. Subsection (6) of section 404.22, Florida Statutes, is amended to read:

404.22 Radiation machines and components;

inspection.— (6)(a) For purposes of this subsection, “mammography” means radiography of the breast for the purpose of enabling a physician to determine the presence, size, location, and extent of cancerous or potentially cancerous tissue in the breast.

(b) All radiation machines used for mammography must:

(a) shall Meet the accreditation criteria of the American College of Radiology or similar criteria established by the department.

(b)(c) All radiation machines used for mammography shall Be specifically designed to perform mammography.

(c)(d) All radiation machines used for mammography shall Be used exclusively to perform mammography.

40 The department shall adopt rules to implement the provisions of this subsection.

Section 3. Section 402.221, Florida Statutes, is created to read:

402.221 Mammography reports.—Each facility that performs mammography shall send a summary of a patient’s mammography report to each patient in accordance with 21 C.F.R.

s.

900.12(c).

If a facility determines that a patient has heterogeneously or extremely dense breasts, the summary must include the following notice:

51 “Your mammogram shows that your breast tissue is dense.

Dense breast tissue is relatively common and is found in approximately 50 percent of women.

The presence of dense breast tissue can make it more difficult to detect some abnormalities in the breast and may also be associated with an increased risk of breast cancer.

This information about the results of your mammogram is given to you to raise your awareness.

A report of your results was sent to your health care provider.

Further recommendations may be added at the discretion of the interpreting radiologist.

Please be aware that additional screening studies may not be covered by your insurance.” 63 (1) This section does not create a duty, a standard of care, or another legal obligation beyond the duty to provide notice as required in this section.

(2) This section does not require a notice that is inconsistent with the federal Mammography Quality Standards Act or any regulation promulgated pursuant to that act.

(3) This section is repealed June 30, 2023.