BILL ANALYSIS Senate Research Center S.B. 1084 89R4042 AB-F By: Campbell Health & Human Services 3/7/2025 As Filed AUTHOR'S / SPONSOR'S STATEMENT OF INTENT The federal Mammography Quality Standards Act (MQSA) requires mammography facilities to provide breast density information to patients and their healthcare providers. The U.S. Food and Drug Administration (FDA) issued a final rule amend the MQSA on March 10, 2023, and facilities had to comply by September 10, 2024. Texas already has the existing "Henda's Law" language requiring disclosure in statute, a law that requires mammography facilities to inform patients with dense breast tissue about the potential risks of breast cancer and the need for supplemental screening. S.B. 1084 seeks to update the state Henda's Law statute and conform the disclosure with the new federal requirements for standardized language relating to dense breast tissue and associated increased risk of breast cancer. Key Provisions Amends Section 86.013(a) of the Health and Safety Code to comply with federal and state reporting requirements and provide one document to the patient with the specific notices based on their breast density classification. Strikes redundant reporting requirements ensuring alignment and uniformity with federal standards for dense breast tissue. As proposed, S.B. 1084 amends current law relating to certain mammography reports providing required breast density information. RULEMAKING AUTHORITY This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency. SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 86.013(a), Health and Safety Code, as follows: (a) Requires a mammography facility certified by the United States Food and Drug Administration or by a certification agency approved by the United States Food and Drug Administration to: (1) be aware of and comply with all applicable federal and state "dense breast" reporting requirements; and (2) on completion of a mammogram provide to the patient: (A) based on the patient's reported breast density, notice that includes one of the following: (i) for a mammography report identifying the patient's breast density as "The breasts are almost entirely fatty" or "There are scattered areas of fibroglandular density," a statement containing certain language; or (ii) for a mammography report identifying the patient's breast density as "The breasts are heterogeneously dense, which may obscure small masses" or "The breasts are extremely dense, which lowers the sensitivity of mammography," a statement containing certain language; and (B) notice that includes a certain statement. Deletes existing text requiring a mammography facility certified by the United States Food and Drug Administration or by a certification agency approved by the United States Food and Drug Administration, on completion of a mammogram, to provide to the patient a notice containing certain language. SECTION 2. Effective date: September 1, 2025.
BILL ANALYSIS
Senate Research Center S.B. 1084
89R4042 AB-F By: Campbell
Health & Human Services
3/7/2025
As Filed
Senate Research Center
S.B. 1084
89R4042 AB-F
By: Campbell
Health & Human Services
3/7/2025
As Filed
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
The federal Mammography Quality Standards Act (MQSA) requires mammography facilities to provide breast density information to patients and their healthcare providers. The U.S. Food and Drug Administration (FDA) issued a final rule amend the MQSA on March 10, 2023, and facilities had to comply by September 10, 2024.
Texas already has the existing "Henda's Law" language requiring disclosure in statute, a law that requires mammography facilities to inform patients with dense breast tissue about the potential risks of breast cancer and the need for supplemental screening.
S.B. 1084 seeks to update the state Henda's Law statute and conform the disclosure with the new federal requirements for standardized language relating to dense breast tissue and associated increased risk of breast cancer.
Key Provisions
Amends Section 86.013(a) of the Health and Safety Code to comply with federal and state reporting requirements and provide one document to the patient with the specific notices based on their breast density classification.
Strikes redundant reporting requirements ensuring alignment and uniformity with federal standards for dense breast tissue.
As proposed, S.B. 1084 amends current law relating to certain mammography reports providing required breast density information.
RULEMAKING AUTHORITY
This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Section 86.013(a), Health and Safety Code, as follows:
(a) Requires a mammography facility certified by the United States Food and Drug Administration or by a certification agency approved by the United States Food and Drug Administration to:
(1) be aware of and comply with all applicable federal and state "dense breast" reporting requirements; and
(2) on completion of a mammogram provide to the patient:
(A) based on the patient's reported breast density, notice that includes one of the following:
(i) for a mammography report identifying the patient's breast density as "The breasts are almost entirely fatty" or "There are scattered areas of fibroglandular density," a statement containing certain language; or
(ii) for a mammography report identifying the patient's breast density as "The breasts are heterogeneously dense, which may obscure small masses" or "The breasts are extremely dense, which lowers the sensitivity of mammography," a statement containing certain language; and
(B) notice that includes a certain statement.
Deletes existing text requiring a mammography facility certified by the United States Food and Drug Administration or by a certification agency approved by the United States Food and Drug Administration, on completion of a mammogram, to provide to the patient a notice containing certain language.
SECTION 2. Effective date: September 1, 2025.