Access to Critical Cancer Screening Tools is At Risk

Author: AmirAli Talasaz, co-Founder & co-CEO of Guardant Health

By now, most Americans have likely heard about the federal court ruling out of Texas regarding access to abortion medication. A second healthcare-related case, also out of Texas, has received less attention, but has the potential to likewise impact healthcare choices for millions of Americans.

This case, Braidwood Management v. Becerra, is nominally centered around the requirement for insurers to cover HIV prevention medication. However, this case has wide-ranging implications for all preventive services that are recommended by the United States Preventive Services Task Force (USPSTF), including lifesaving cancer screenings. The ruling against the Biden Administration in Braidwood has us deeply concerned.

The USPSTF is an independent, volunteer panel of researchers and clinicians that develops national guidelines for preventive services. These experts review new evidence and screening technologies and update their recommendations, greatly influencing the care eligible Americans receive.

Cancer still claims hundreds of thousands of American lives each year despite advances in detection and treatment. President Biden recognized the devastating impact of this disease by doubling down on his Cancer Moonshot Initiative, working alongside the scientific community to make accessible cancer screening a reality. But Braidwood could undermine this effort.

Today, private insurers must cover certain USPSTF-recommended preventive services at no cost to patients. So, when the USPSTF recommends a screening, far more people can access and benefit from it.

The Braidwood decision states that the USPSTF doesn’t have the authority to mandate insurance coverage because it is independent and does not have Administration oversight of its recommendations. In short, the judge ruled that this violates the Appointments Clause of the Constitution.

As the case moves through the judicial system, Congress, the Administration, and the private sector must remain committed to improving cancer screening rates and patient access to preventive services. Take colorectal cancer (CRC) screening for example. Adherence to CRC screening is nowhere near the CDC’s goal of 80%. This disease disproportionately impacts minority communities with Black Americans having a 40% higher chance of dying from CRC than the rest of the population. Access to screening is a huge leap forward to correct this inequity.

If patients face out-of-pocket costs, will they get the recommended CRC screening? Studies show that even small co-payments can deter patients from seeking preventive care. A return of cost-sharing is likely to exacerbate the inequities we already see in cancer screening rates and mortality.

This case also jeopardizes access to future innovation in cancer screening. New, cutting-edge technologies like Guardant’s Shield™ blood-based screening test to detect CRC have the potential to help close screening gaps and drastically reduce CRC mortality while improving patient outcomes. Blood-based screening tests, which can be easily incorporated into routine primary care visits, are often preferred over other screening methods. For patients to truly have access to cancer screening, insurers must be required to pay for novel technologies – when such tests are FDA approved and recommended in clinical practice guidelines.

Furthermore, the Braidwood decision threatens the potential for broader applications of early detection tools like Guardant Shield. Already successful in the early detection of CRC, Guardant Health continues to develop Shield to screen for additional cancer types in which early detection is critical including in lung, breast, and other cancer types with no screening options.

Well before Braidwood, members of both parties acknowledged the crucial role USPSTF plays in access to preventive services. Congress has urged the Agency for Healthcare Research and Quality (AHRQ) and the USPSTF to adapt and update the recommendation process to better match the pace of innovation. Representative Lisa Blunt Rochester has also introduced the Preventive Services Early Action Act to put some of these policy changes in place, and the President’s FY2024 budget proposes additional funding for the important work of the USPSTF.

While access to preventive services remains in place today, the future is uncertain. The U.S. 5th Circuit Court of Appeal has heard arguments for the Braidwood case and a final ruling could come at the end of the year. Meanwhile, Congress and the Biden Administration could ensure access to cancer screenings by clarifying the law. Now more than ever, protecting and strengthening the USPSTF process will help safeguard access to preventive services, and future access to screening innovations, once and for all.

Last February, President Biden stated that Americans have missed more than 9.5 million cancer screenings in the last two years because of COVID. “We have to get cancer screenings back on track and make sure that they are accessible to all Americans,” he said.

We agree. And to be successful, we must facilitate, not further complicate, patient access to preventive care. Cancer screening should be equitable, convenient, routine, and accessible to everyone.

Without action, our shared goals of ensuring all eligible Americans are screened for cancer will remain out of reach.

Dr. AmirAli Talasaz is the co-Founder and co-CEO of Guardant Health Inc., a precision oncology company based in Palo Alto, Calif.

The editorial staff had no role in this post's creation.