USPSTF reform: Will lame-duck Congress act?

Over the past several months leading up to the November presidential and congressional elections, organizations representing urology sought to persuade members of Congress to bring sense and reason to the U.S. Preventive Services Task Force (USPSTF), which nearly 5 years ago gave a “D” rating to PSA-based screening for prostate cancer.

Bob GattyWashington-Over the past several months leading up to the November presidential and congressional elections, organizations representing urology sought to persuade members of Congress to bring sense and reason to the U.S. Preventive Services Task Force (USPSTF), which nearly 5 years ago gave a “D” rating to PSA-based screening for prostate cancer.

That decision became even more important to urology after the Affordable Care Act (ACA) was enacted, since it gives what was essentially an advisory recommendation the force of law, turning it into a mandate on which private and public programs would base reimbursement decisions.

Urology groups lobby subcommittee

All of that hard work, which included meetings with lawmakers on Capitol Hill, letters urging approval of remedial legislation, and other forms of election year political persuasion, appears to be paying dividends.

At the urging of urology and other specialty groups, the House Energy & Commerce Committee’s Health Subcommittee held a hearing Nov. 30 to consider reform legislation designed to make the USPSTF’s decision-making process more transparent and assure that specialists’ expertise is considered when making decisions. However, it is likely that the matter will have to be settled by the 115th Congress after it convenes in January and targets the ACA for repeal.

Testifying on behalf of the AUA, John H. Lynch, MD, said “providers and patients alike were left confused or disagreed” with the PSA recommendation. “Rather than issuing a blanket recommendation against screening, it would be better to ‘screen smarter’ by testing most men at a higher risk for the disease,” Dr. Lynch said.

The goal is to win enactment of legislation sponsored by Rep. Bobby Rush (D-IL) and Rep. Marsha Blackburn (R-TN), 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.

The key objection to the USPSTF’s current procedures is 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.

“The USPSTF’s decisions are not subject to public comment, feedback, or scrutiny,” said Gary M. Kirsh, MD, past president of LUGPA. “When the PSA recommendation came out, they did not allow or solicit input from subject matter experts. They did not issue a preliminary report for comment. None was permitted. The whole thing is preposterous.”

The USPSTF disputed Dr. Kirsh’s statement, pointing out that a draft version of the USPSTF PSA recommendation was posted for public comment on the USPSTF web site from Oct. 11, 2011 to Dec. 13, 2011. Comments were reviewed and a summary of public comment themes was included by the task force in its final recommendation statement.

Dr. Kirsh pointed out that under the ACA, the Secretary of Health and Human Services has the right to enforce USPSTF recommendations with Medicare, which would then be followed by private carriers.

“So that would be a coverage termination for the whole country,” Dr. Kirsh said.

Jeff Frankel, MD, a Seattle urologist who is the American Association of Clinical Urologists’ health policy chair, concurs.

The problem, he said, is that the task force makes decisions about subjects in which they do not have expertise.

“We think the decision-making process should be more open, and that’s what we’re concentrating on,” he said.

Dr. Frankel also pointed out that USPSTF is required to provide an update 5 years after the initial recommendation, which would be in mid-2017.

“We’ll be watching to see if USPSTF changes its position based on data that has come out since then,” he said.

“USPSTF seems to focus on the harms of PSA screening,” he observed. “They need to focus on the harms of not screening.”

Since the 2012 “D” rating for PSA, Dr. Frankel said PSA tests have declined, resulting in fewer referrals to urologists and fewer workups.

Next: Bill would require draft research plan

Bill would require draft research plan

The legislation in question, the USPSTF Transparency and Accountability Act, seeks to remedy some of these problems within the USPSTF process. It would require the USPSTF to:

publish a draft research plan (including analytic frameworks, key questions and a literature search strategy, plus methodological guidelines) to guide the systematic evidence review process

consider findings and research by federal agencies and departments

make the evidence review available for public comment

coordinate activity with other federal departments

consult with “external subject matter experts,” including provider and patient representatives.

The bill also would establish a Preventive Services Task Force Board comprised of providers, patient groups, and federal agency representatives, which would make recommendations to the USPSTF and suggest evidence for consideration, and provide feedback on recommendations and help disseminate them when finalized.

Barring a miracle resulting in the legislation being passed by both chambers of Congress and signed by President Obama before he leaves office next month, it will have to be reintroduced next year.

However, the educational process that has been conducted by the medical community will prove to be invaluable as the process moves forward.

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