As radiology’s first screening tool, mammography has measurably transformed women’s health through the decades. By detecting breast cancer early enough to effectively treat it, mammography screening has reduced breast cancer mortality by 40% since the mid-1980s — saving over a quarter of a million lives since then.1
Yet concerns and controversies have surrounded mammography from the start. Variations in imaging quality and interpretation led to early inconsistencies that impeded the lifesaving power of mammography. In the 1985 Nationwide Evaluation of X-ray Trends (NEXT) survey, the FDA found that 36% of mammography facilities were producing images of unacceptable quality.2
Addressing concerns for patient safety and quality, the ACR stepped up to establish the first imaging accreditation program, which was later codified into law. Since then, the ACR has led the charge for mammography quality standards and screening coverage — advancing women’s health while paving the way for quality improvements in other medical specialties.
Setting Quality Standards
To address the inconsistencies that plagued screening facilities early on, the ACR initiated the country’s first Mammography Accreditation Program in August 1987. The voluntary program, developed by imaging experts on the ACR’s Task Force on Breast Cancer, established standards for mammography equipment, staff qualifications, image quality and radiation dose.
Initially, 30% of facilities failed the Mammography Accreditation Program on their first attempt.3 Leveraging peer reviews and comprehensive assessments, the ACR provided feedback from mammography experts to recommend quality improvements.
“The goal of accreditation is to help facilities improve the quality of care and imaging they provide,” says Pamela A. Wilcox, RN, MBA, who joined the ACR department of standards and accreditation in December 1987 and led the renamed quality and safety department until her retirement in 2015. “The program really made a difference because it focused on the educational piece of accreditation — not making it punitive but teaching radiologists the right way to achieve quality imaging.”
ACR’s Mammography Accreditation Program grew rapidly as it gained wide acceptance. By 1991, half of the estimated 10,000 mammography units in the U.S. had applied for accreditation, and approximately one-quarter had achieved it.4
Fighting for Coverage
Meanwhile, to ensure that women had access to breast cancer screening, the ACR lobbied legislators to mandate Medicare coverage for mammograms. Advocates like longtime ACR lobbyist Donald F. Lavanty, JD, worked closely with legislators and other clinical organizations to carry mammography quality and coverage issues to Congress.
“The ACR was the policy leader for women’s health because we wanted to ensure quality care,” Lavanty says. “We made it apparent to legislators that women’s health had been an afterthought for too long.”
In 1990, thanks to the ACR’s advocacy efforts, Congress passed legislation authorizing Medicare coverage for mammography — marking the first-ever Medicare screening provision. The legislation required facilities seeking Medicare reimbursement to meet quality standards similar to ACR’s Mammography Accreditation Program.
This coverage paved the way for other modes of screening in women’s health and beyond — from cervical and colorectal cancer to glaucoma. “It became apparent to policymakers that if we can screen, we can detect and treat cancer quicker, which will save lives and save money downstream,” Lavanty says. “If it hadn’t been for mammography, there would be no screening provisions.”
Mandating Mammography Accreditation
Recognizing the need for national standards beyond Medicare, the ACR continued working with legislators and partner organizations, like Susan G. Komen and the American Cancer Society (ACS), to mandate mammography accreditation across the U.S.
Seeing the success of the ACR’s voluntary efforts to improve imaging quality, Congress modeled legislation after the ACR’s Mammography Accreditation Program. The Mammography Quality Standards Act (MQSA), passed by Congress in 1992, requires all U.S. mammography facilities to be certified and accredited by an FDA-approved body. The ACR became the first accrediting body and remains the largest by far, accrediting more than 90% of the mammography facilities in the U.S.5
“The law basically said that no center should be authorized to do screening mammography unless it met standards equivalent to those established by the ACR’s accreditation program,” says Lavanty, who lobbied to make mammography accreditation mandatory. “That really set us as the benchmark.”
After 1996, when most facilities had become accredited and certified, the first-attempt pass rate of ACR’s accreditation program jumped from pre-MQSA levels of 70% to more than 85%. By 2003, the rate neared 90% — indicating drastic quality improvement as a result of mandatory accreditation.6
As one of the most successful quality improvement programs in the history of radiology, ACR’s Mammography Accreditation Program provided a springboard for standards in other modalities. The ACR added accreditation programs for ultrasound in 1995, stereotactic breast biopsy and MRI in 1996, breast US in 1998, nuclear medicine in 1999 and CT and PET in 2002. Radiation oncology accreditation began previously, in 1986.
Since 1987, the ACR has accredited more than 38,000 facilities across nine imaging modalities — guiding quality improvement in nearly every area of medicine.7 Today, ACR accreditation is widely recognized as the gold standard in medical imaging. “These accreditation programs and quality initiatives are what give the ACR respect when we go to Congress, CMS or other payers,” Wilcox says, “because we’ve shown that we hold our members to a high standard of care.”
Agreeing on a set of reporting standards had a huge impact on women's health, because it added clarity around mammography findings and next steps.
Establishing Reporting Guidelines
In addition to quality variations, early mammography reports were often variable and vague — lacking clear recommendations for referring physicians or patients. To reduce this confusion, the ACR developed the Breast Imaging-Reporting and Data System (BI-RADS®) as a solution “to improve reporting consistency and provide better feedback and direction,” Wilcox says.
The ACR convened a committee of breast imaging experts — with advisors from organizations like the ACS, the College of American Pathologists and the American College of Surgeons — to define standardized assessment categories for describing mammography findings and possible diagnoses. First published in 1990, BI-RADS provided a scoring system for breast radiologists to concisely communicate cancer risks and consistently recommend follow-up imaging.
“Although we take it for granted now, that was an incredibly forward-thinking idea to say, ‘Hey, we need to communicate mammogram interpretations clearly, so clinicians and patients understand each other when discussing the findings,’” says Debra L. Monticciolo, MD, FACR, past president of the ACR and former chair of both the Commission on Quality and Safety and the Commission on Breast Imaging. “Agreeing on a set of reporting standards had a huge impact on women’s health, because it added clarity around mammography findings and next steps.”
Initially established for mammography, the BI-RADS lexicon soon expanded to include other modalities like ultrasound and MRI as the ACR’s reporting standards evolved. The success of these quality assurance tools opened the door to other standardized reporting systems beyond women’s health, like Lung-RADS® for lung cancer screening, LI-RADS® for liver imaging and TI-RADS™ for thyroid imaging.
“The ACR has developed quality programs and reporting standards that serve as templates for new technologies,” Monticciolo says. “That’s a massive effort on the part of the ACR to make sure
imaging standards are uniform.”
Promoting Regular Screening
While debates erupted between legislators, insurance payers and health organizations about when and how often to screen, the ACR relied on evidence-based research to recommend the most lifesaving mammography guidelines.
“The ACR has steadfastly supported screening women annually starting at age 40,” says Monticciolo, division chief of breast imaging and co-director of the Avon Comprehensive Breast Evaluation Center at Massachusetts General Hospital. “The evidence for that recommendation is overwhelming.”
Breast imaging experts from the ACR and the Society for Breast Imaging (SBI) reviewed extensive data from randomized controlled trials, observational trials and peer-reviewed literature to conclude that annual screening starting at age 40 provides the greatest mortality reduction through early-stage diagnosis, leading to more effective treatment options with better outcomes.8 Other leading clinical organizations, including the ACS, the AMA and the National Comprehensive Cancer Network, support these recommendations.
“There have been controversial debates about screening guidelines,” Wilcox says, “but the ACR continues to look at the studies and review new data as it comes out to demonstrate that screening women starting at age 40 saves the most lives.”
That work is ongoing, says Stamatia V. Destounis, MD, FACR, chair of the ACR Commission on Breast Imaging and managing partner at Elizabeth Wende Breast Care in Rochester, N.Y. “Since 2018, the ACR breast cancer screening guidelines were updated after careful review of screening studies and new information to include heightened attention for minority women, transgender individuals and other often overlooked or underserved populations,” she says. Additionally, “the ACR recommends risk assessment evaluation of patients by age 30 to identify patients at higher risk who should start screening earlier than age 40.”
Thanks to the ACR’s ongoing research and advocacy efforts, legislation like the Protecting Access to Lifesaving Screenings (PALS) Act of 2021 ensures mammography coverage is in line with the ACR’s evidence-based recommendations.
“Women in this country have their mammograms covered starting at age 40 because of the ACR’s work at the legislative level,” Monticciolo says. “These efforts have been absolutely key to making sure women have access to mammography.”
Building a Quality Image
Through the decades, the ACR’s efforts to advance mammography screening quality and coverage impacted women’s health by saving countless lives through early detection. These advances became standards — ultimately setting benchmarks that benefit various imaging modalities outside of women’s health and even specialties beyond radiology. The advances that set the gold standard in mammography have become key cornerstones in ACR’s strong reputation for quality.
“The ACR has been the leader in imaging quality, accreditation, reporting, improving standards and educating radiologists and women about the importance and impact of screening,” Monticciolo says. “The impact we’ve had on advancing breast health specifically, and screening in general, has been absolutely phenomenal. And I’m really looking forward to the future, because the ACR will continue to make an impact going forward.”