Key takeaways:

• HHS is not complying with Congress’ intentions for USPSTF by canceling meetings, an expert said.
• But there are no codified regulations requiring HHS to comply or avoid political interference in the task force.

It has been nearly a year since the U.S. Preventive Services Task Force released new recommendations, and experts remain concerned about its future.

HHS removed the chair and vice chair of USPSTF last month, which came after three task force meetings were canceled under HHS Secretary Robert F. Kennedy Jr.’s tenure.

Alex H. Krist, MD, MPH, a former USPSTF member, previously told Healio that the task force now consists of eight members, although no chairs or vice chairs remain. The USPSTF usually consists of 16 members, but it has been a while since new members were appointed.

The task force’s procedure manual states that the USPSTF is led by a chair and two vice chairs, but it does not specify how long the task force can operate without these roles filled, according to Carmel Shachar, JD, MPH, faculty director at Harvard Law School.

Without leadership, Krist said he is concerned that incoming members will not receive the necessary training and education.

“There was a process where every new task force member was assigned a senior task force member as a mentor. That’s been an established process used internally for decades,” he said. “The mentor is really helping to make sure that new members are able to adopt and adhere the task force’s methods and approach, be able to do the volume of work effectively and focus on the things that matter. The chairs were so instrumental at training and leading.”

Healio spoke with Shachar to understand what HHS’ legal obligations are for USPSTF, if it could face consequences for incompliance and more.

Healio: What are HHS’ legal obligations to maintain a functioning task force?

Shachar: HHS has an obligation to carry out Congress’ intent and directives. It’s circumventing it by maintaining a USPSTF that doesn’t ever meet. Even if it technically meets the letter of the law — because the statute doesn’t mandate exactly how many times a year they should meet — it doesn’t meet the intent.

There is also the fact that USPSTF needs to meet in order to issue recommendations, and recommendations have to be issued so that they are incorporated into the no-cost preventive care mandate. There isn’t language in the authorizing statute or the Affordable Care Act (ACA) saying that you need to keep the USPSTF in good working order, but it implied throughout.

Healio: If it’s implied, is HHS not complying with its duties, and could it face any legal consequences?

Shachar: One of the challenges here is that a lot of USPSTF procedures are in their procedural manual, but those are not codified into regulation, so it doesn’t have the force of law. That means that even though you could point to saying things like, “The manual requires that USPSTF meet three times a year,” but those meetings haven’t been occurring, you can’t really take HHS to court the way that you could if it was codified into the regulation.

Another part of the challenge is that the way our government works is that Congress writes a statute, but the statute isn’t the full recipe. The statute is the bare bones: “Here’s what we absolutely want to see, here’s the purpose in doing this,” and then it’s usually up to the agency to flesh that out through regulations.

Healio: Are there laws that prohibit political interference within the task force?

Shachar: This was actually an issue that was part of the Kennedy v. Braidwood Management Inc. case a couple years ago. The ACA has language saying that the USPSTF needs to be independent from political interference. What exactly that meant was debated in front of the Supreme Court about how much that language insulates the USPSTF from political pressures. It’s supposed to be just a nonpartisan panel of experts, but as I think we’ve seen over the last couple of years with USPSTF and Advisory Committee on Immunization Practices, it is hard to completely insulate an advisory group from political pressures.

Healio: Do you have anything else you’d like to add?

Shachar: The important thing to understand is that there are some rules in how the USPSTF operates. For example, they need to review scientific evidence and consider best practices from a variety of sources like the CDC and NIH as well as the medical societies. So, it’s not that there’s absolutely no rules here and it’s a wild west, but that the challenge there is that it’s just a manual, it’s not regulations.

Editor’s note: HHS has not yet responded to Healio’s questions about when the task force is expected to meet or issue new recommendations

For more information:

Carmel Shachar, JD, MPH, is a faculty director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation and an assistant clinical professor of law at Harvard Law School. She can be reached at primarycare@healio.com.