USPSTF reform: PSA at forefront of Capitol Hill hearing

Bob GattyOrganized urology, including the AUA and LUGPA, made its case for U.S. Preventive Services Task Force reform during a recent hearing of the House Energy and Commerce Health Subcommittee.

The head of the USPSTF, the government agency that recommended in 2012 against routine PSA tests for men, said one of the key reasons that specialists like urologists are not included on the Task Force is because they may have a financial interest in the recommendations being considered.

“Because the livelihoods of sub-specialists are often directly affected by our guidelines (thus giving the appearance of a financial or intellectual conflict) and because many sub-specialists have specific ties to the industries that make screening tests or treatments, per the USPSTF conflict-of-interest protocols, these conflicts would likely prohibit most sub-specialists from serving on the USPSTF, or at the very least would preclude them from supporting the few topics for which they have expertise,” Kirsten Bibbins-Domingo, MD, PhD, MAS, chair of the USPSTF, told the House Energy and Commerce Health Subcommittee during the Nov. 30 hearing.

“We are committed to making guidelines that are trustworthy and free of bias,” she declared.

The hearing was to consider legislation sponsored by Rep. Marsha Blackburn (R-TN) and Rep. Bobby Rush (D-IL), which includes a requirement that primary care and specialty care providers, along with other health care experts, are involved in the development and review of USPSTF recommendations.

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Organizations representing urologists have been among those representing specialists charging that recommendations that have a critical impact on health care policy and procedures are made without input from experts on the subject involved and that there is little that can be done once those recommendations are made.

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Testifying at the hearing on behalf of the AUA, urologist John H. Lynch, MD, of MedStar Georgetown University Hospital, Washington, said there is a “disconnect” between practicing physicians and the Task Force caused by its composition, which includes primary care physicians but not specialists.

“While the USPSTF is composed of independent, national experts in prevention and evidence-based medicine, representation by urology or other medical specialties is noticeably absent when recommendations or research plans are under review,” he said. “I understand that every specialty provider cannot be represented full time on the Task Force, but having a specialty voice for individual recommendations can improve the outreach and review process.

“It is a disservice to patients to issue recommendations on the primary method used to diagnose prostate cancer or other conditions without consulting with those physicians who work with patients every day,” Dr. Lynch added.

Asked by Blackburn, a committee member, if the USPSTF sought input from the AUA or clinical oncologists regarding the PSA recommendation, Dr. Bibbins-Domingo said she could not be certain. However, she added, “We routinely engage in the specialty societies that have expertise in these topics, including to get feedback.”

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In his testimony, Dr. Lynch outlined the reasons why urologists believe the 2012 recommendation was wrong, noting that he is a prostate cancer survivor and that “early detection saved my life, which is why this hearing is so important.”

“I, and many other urologists, strongly disagree with the Task Force’s assessment,” said Dr. Lynch. “Rather than issuing a blanket recommendation against screening, it would be better to ‘screen smarter’ by testing most men at individualized intervals (not every year) and adding additional focus to how we screen men at higher risk for disease. These decisions are best made between the physician and patient, taking into consideration their individual risk factors and family history.”

In testimony submitted to the subcommittee, Neal D. Shore, MD, president of LUGPA, and Deepak A. Kapoor, MD, chairman of health policy, went into great detail regarding use of the PSA and other screening methodologies for prostate cancer.

As a result of the 2012 recommendation, they said, “Many fewer men are being screened for prostate cancer; data shows that those being diagnosed with prostate cancer are being found with later stage, more aggressive disease. The cure rate for these patients is much lower, potentially leading to unnecessary deaths from prostate cancer.”

Next: "THe USPSTF has improved its's outreach to the public and stakeholders, but more needs to be done."

Dr. Lynch was asked by Blackburn to explain the impact that the USPSTF decision has on patients.

“About eight weeks ago, I had a patient with urologic symptoms come to me. He had prostate cancer that had spread throughout his skeleton. He asked me why he didn’t get that test. That was a difficult discussion,” Dr. Lynch recalled.

Dr. Lynch described as “a good thing” the fact that the USPSTF is now considering an update of its PSA screening recommendation, but said it should happen more frequently than after 5 years. Dr. Bibbins-Domingo stressed the update review includes 15 sub-specialty experts in prostate cancer, including three urologists in a non-voting capacity.

Dr. Lynch also observed that since the Blackburn bill was first introduced, “The USPSTF has improved its outreach to the public and stakeholders, but more needs to be done,” including publishing draft research plans and soliciting public comment in the Federal Register and providing adequate time for comment and review by external subject matter experts. Public comments should be made publicly available and a summary of comments received and recommendations of other federal agencies or organizations relating to the topic should be included.

Dr. Bibbins-Domingo told committee members that research plans and comments are published on the agency’s “robust” website.

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“Transparency is core to us,” she said. “If people don’t trust our recommendations, it is not good because we want people to use our recommendations. That is why we talk to as many groups as we can.”

Opening the hearing, subcommittee chair Rep. Joseph R. Pitts (R-PA) noted that the Task Force’s PSA recommendation has limited access to preventive care, as did another USPSTF recommendation against routine annual mammogram screenings for women ages 40-49.

“Such recommendations contradict clinical guidelines based on medical literature and experts in the field,” Pitts said. “The concerns are that these recommendations could undermine new models of care delivery.”

There is a good chance that the Blackburn legislation will win approval of the GOP-controlled Congress, perhaps as part of the move early next year to repeal the Affordable Care Act, pledged by President-elect Trump. The ACA ties Task Force recommendations directly to insurance reimbursement requirements.

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