Imaging leaders sound off on legal challenge to free preventive services

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A federal court ruling that vacated nationwide insurance mandates for free preventive services such as cancer screenings will have "major ramifications" for people seeking these services as well as for public health overall, according to imaging leaders and legal experts.

The March ruling by Judge Reed O'Connor from the U.S. District Court for the Northern District of Texas vacated nationally the Patient Protection and Affordable Care Act's (ACA's) preventive service insurance mandate for services recommended by the U.S. Preventive Services Task Force (USPSTF). This part of the bill had mandated that group health plans and health insurers cover preventive health services such as cancer screenings, immunizations, and contraceptives without burdening patients with out-of-pocket, co-insurance, and deductible costs.

A devastating blow

Although breast cancer screening appears not to be affected by the ruling, it could still have a significant impact on other forms of cancer screening.

"The loss of the ability to receive these services without out-of-pocket costs is a devastating blow to the delivery of preventive care services to Americans," said attorney Tom Greeson, partner at Reed Smith.

O'Connor's ruling comes in the case of Braidwood Management, Inc., et al. v. Xavier Becerra, et al. Here, O'Connor sided with Texas-based employers who argued that the ACA's provision that directed businesses to provide employees with free coverage of such preventive health services was unconstitutional. O'Connor also ruled that enforcing recommendations issued by the USPSTF was "unlawful."

O'Connor also ruled in September 2022 that USPSTF members are not Senate-confirmed, meaning that the task force is not constitutionally permitted to determine coverages as instructed by ACA. The USPSTF is an independent panel of experts in primary care and prevention. It develops recommendations for clinical preventive services based on reviews of scientific studies.

"The court seems to view their [USPSTF] work as a political arm of government when their work is actually evidence-based," Greeson said.

Gloria Romanelli, senior director of regulatory relations, legal counsel, quality and safety from the American College of Radiology (ACR), said that the effects of co-pays and deductibles would "severely" impact individuals most at risk and with the least ability to pay, including minority populations and those in underserved areas.

"The ACR is deeply concerned by the decision," Romanelli said. "Lung cancer screening was not endorsed by the USPSTF until December 2013, [and this] may lead to out-of-pocket costs for patients. In addition, CT colonography for colorectal cancer screenings currently covered by private insurers through the ACA would also be of concern."

Response from health organizations

USPSTF task force chair Dr. Michael Barry said in a statement to that people across the country fundamentally "deserve the opportunity to receive these important preventive services that have been proven to help them live longer and healthier lives."

"From helping people find cancers early to preventing kids from starting to smoke, we believe that clinicians and patients have a right to know what the evidence shows about how best to stay healthy. In recent years, we have seen the impact of this work, especially on those most in need of healthcare," Barry said. "Millions of people across the country rely on these services every day to help them get and stay healthy. And as care has become more accessible over the past decade, more people who have low incomes have been able to access the care they need, such as screening for both colorectal and cervical cancer."

Recent legislative efforts on the state level have attempted to expand free coverage for patients who require diagnostic breast imaging, such as supplemental ultrasound or MRI. This especially goes for women who have dense breast tissue, where conventional mammography struggles in finding breast cancer. Breast cancer organization Susan G. Komen has supported the introduction of bills seeking to expand such coverage.

Molly Guthrie, vice president for policy and advocacy at Komen, said that while removing the cost barrier for preventive screening is a "first step," it has led to upticks in screening attendance.

While the court decision may leave intact ACA coverage for preventive services provided by guidelines from the Health Resources and Services Administration (HRSA) -- such as breast cancer screening -- and certain immunizations recommended by the Centers for Disease Control and Prevention (CDC), Guthrie added that the ruling would also impact genetic testing and counseling that also comes with breast cancer risk determination and treatment.

"For the broader community at large, this will have a horrible impact on the health of the nation," she said, adding that Komen is "staunchly against" the ruling. "We're at a place now where we have great treatments available, but the treatments aren't beneficial when they [diseases] are diagnosed later. So, removing these preventive services is extremely detrimental to men and women across the country."

In an editorial published April 10 in JAMA, journal Executive Editor Dr. Gregory Curfman and Editor-in-Chief Dr. Kirsten Bibbins-Domingo, PhD, argued that O'Connor's ruling is more ideology-based.

"The judge's legal argument, based as it is on the Article II Appointments Clause, seems technical and obscure. It appears to have been explicitly designed to eliminate the valuable role the USPSTF has played in preserving the nation's health," Curfman and Bibbins-Domingo wrote. "The judge has chosen instead to favor the religious interests of the plaintiffs, who do not want to provide coverage for their employees for certain preventive health services."

What's next?

O'Connor previously ruled in 2018 that ACA was unconstitutional. While the decision was upheld on appeal to the U.S. Court of Appeals for the Fifth Circuit, it was reversed by the U.S. Supreme Court in a 7-2 ruling made in 2021.

Greeson said the "clear" next step for the Braidwood case will be subject to an appeal, with the case working its way up through the U.S. Court of Appeals and possibly the U.S. Supreme Court.

"This is very high-stakes litigation that's important to public policy, so this is not over by any stretch of the imagination," he added. "One hopes that reason will prevail."

Romanelli said the ACR is exploring the potential impact of the court decision, getting member feedback and monitoring the federal government's response.

Komen will continue to advocate for better breast cancer screening access, Guthrie told She concurred that the ruling has a long way to go.

"We know how important of a tool early detection is," she said. "We'll do everything we can to ensure that not only are those modalities in screening are covered, but that they're covered without cost-sharing."

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