This final rule will modernize mammography regulations by incorporating current science and mammography best practices to improve the delivery of mammography services. These updates include requirements on recordkeeping, reporting, and communication of results. This final rule also addresses procedural requirements in several areas related to quality control and management of mammography facilities.

The quantified benefits are derived from reduced mortality and breast cancer treatment costs resulting from the breast density reporting requirements. We use two methods of measuring the value of reduced mortality: the value per statistical life (VSL) approach and an approach based on the value of lost life years (LY). Under the VSL approach, the estimate of annualized benefits over 10 years ranges from $42.00 million to $232.69 million at a 7 percent discount rate. Using a 3 percent discount rate, the annualized benefits range from $48.42 million to $266.09 million. Under the LY approach, the estimate of annualized benefits over 10 years ranges from $12.99 million to $66.90 million at a 7 percent discount rate. Using a 3 percent discount rate, the annualized benefits range from $8.50 million to $37.96 million. Because there is uncertainty in the literature about the most appropriate method for analyzing reduced mortality for the population affected by this final rule, we report the high estimate based on the VSL approach and the low estimate based on the LY approach. Other benefits that we are not able to quantify include reduced cancer morbidity and improvements in the accuracy of mammography by improving quality control and strengthening the medical audit.   

The costs of the final rule include costs to mammography facilities to comply with the requirements of the regulation and costs associated with supplemental testing and biopsies resulting from the breast density requirements. The estimate of annualized costs over 10 years range from $28.87 million to $45.42 million at a 7 percent discount rate with a primary value of $36.31 million.  Using a 3 percent discount rate, the annualized costs range from $27.61 million to $44.16 million with a primary value of $35.05 million.

Regulatory Impact Analysis

Mammography Final RIA (PDF – 517 KB)

Federal Register: 88 FR 15126, March 10, 2023
Docket: FDA-2013-N-0134