| Chris Klomp answered lawmakers at the Senate Finance Committee Tuesday in his first confirmation hearing to serve as deputy secretary of Health and Human Services, a role left vacant after Jim O’Neill stepped down in February. Klomp currently serves as chief counselor at the Department of Health and Human Services and has served as director of Medicare at the Centers for Medicare and Medicaid Services. If confirmed, he would become Health Secretary Robert F. Kennedy Jr.’s second-in-command, formally putting him in a position to help oversee the department’s sprawling health care agenda. Here are three key policy issues raised in the hearing: 1. Vaccine policy Vaccines emerged as a test of how Klomp would navigate Kennedy’s controversial views while overseeing a department responsible for national vaccination policy. Several Democrats pressed Klomp on how he may differ from Kennedy and President Donald Trump, who have called for sweeping changes to the childhood vaccination schedule. Klomp often demurred, emphasizing that the measles vaccine is effective. “My job, if confirmed, is to ensure smooth operations,” Klomp said. “It’s to make sure that we are communicating clearly, that we are earning trust, that we are reaching people where they are. To sweep questions under the rug of those who are skeptical will not solve the problem.” Klomp defended Trump’s executive order that called for separating the combination measles, mumps and rubella (MMR) vaccine into three shots, saying it would give parents an alternative option for those who want it. → New: This comes as Pennsylvania has now recorded a fourth measles-associated death, my colleagues Rachel Roubein and Daniel Wu in The Post newsroom report today. (Manufacturers of the MMR vaccine have stood by their product’s safety and efficacy. They do not offer separate shots, and it would require a new set of clinical trials and a multiyear development process.) But Klomp also sought to draw a line around how research under HHS should be conducted. Sen. Raphael Warnock (D-Georgia) asked Klomp whether he would fire any staff “who peddle dangerous anti-vaccine ideology or policies that contradict settled science.” “I will fire anyone who does not follow the scientific method,” Klomp said, calling for “appropriate datasets,” peer review and a commitment to publish results regardless of whether researchers like the findings. “I want qualified principal investigators, not on fishing expeditions, but on hypothesis-driven research,” Klomp said. 2. Details about most-favored-nation drug-pricing deals Sen. Steve Daines (R-Montana) raised concerns that the Trump administration’s mandatory pricing models offering most-favored-nation (MFN) pricing in Medicare could disproportionately hurt small and midsize biotech companies by making it harder to attract investment and fund research and development. Those experimental pilots — which would compel drugmakers to lower their prices to match other wealthy nations in Medicare Part D and Medicare Part B — are under review at the White House. The pharmaceutical industry has strongly pushed back on the models, calling them illegal. The large drugmakers that cut pricing deals with the Trump administration are likely exempt: Many have stated their deals carve them out from having to participate. Danies, who recently went on a trip to China, said he’s worried about “the impact these models could have on the American biotech industry, especially at this moment when China is rapidly closing the innovation gap and seeking to overtake the United States as a global leader in biotech.” Klomp said Trump had given HHS two mandates: Lower what Americans pay for drugs by getting other wealthy countries to pay more and “do not harm American leadership in biotechnology.” He acknowledged the competition from China, saying the United States cannot afford to “cede” the biotechnology industry to other countries. Separately, Sens. Ron Wyden (D-Oregon) and Elizabeth Warren (D-Massachusetts) pressed Klomp on the administration’s recent drug-pricing agreements with manufacturers. Warren demanded details on what the companies received in exchange for agreeing to lower prices, which she said Kennedy had promised senators during budget hearings on Capitol Hill earlier this year. It signals where Democrats may probe should they win back control of the Senate in November’s midterm elections. “I want to know what was given away in these contracts,” Warren said. “Until then, you can stop telling us it was all great for the American people but you refuse to show us the receipts. That’s not how oversight works.” Klomp, who played a key part in bringing the deals together, said the details needed to remain confidential to avoid releasing trade secrets and other proprietary information. “I know that you care deeply about lowering prescription drug prices for Americans. I agree with you strongly on this point,” Klomp said. “I know that you wouldn’t want to do something that would compromise the U.S. government’s ability to continue negotiating… we are actively negotiating.” 3. Pharmacy benefit managers In what felt like somewhat of a wild card, pharmacy benefit managers (PBMs) — which negotiate discounts with drugmakers and decide which medicines an insurance plan will cover — emerged as another issue to watch. Sen. James Lankford (R-Oklahoma) pointed to a law originating in the Senate Finance Committee enacted earlier this year that included new PBM reforms aimed at increasing transparency and protecting access to lower-cost drugs. Klomp signaled that HHS wants to work with Congress on legislation to give the department more authority over pharmacy benefit managers, particularly on the issue of transparency. “We at the department lack certain regulatory authorities to make progress,” Klomp said, adding that HHS could provide lawmakers and congressional staff with “deep technical expertise” on how to increase transparency and understand the return employers and others get through the PBM system. He also endorsed efforts to change incentives that can make it harder for generics and biosimilars to compete with brand-name drugs. “This is a principle of competition,” Klomp said. “Anything that we can do to increase transparency — so that employers, in particular, understand what they’re spending money on and what they’re getting — will increase competition.” → Klomp will undergo a second round of questioning Wednesday, when he appears before the Senate Health, Education, Labor and Pensions Committee alongside Nicole Saphier, Trump’s pick for surgeon general, and Timothy Westlake, the nominee to lead the Substance Abuse and Mental Health Services Administration. AI is moving deeper into health care, with tech companies increasingly gaining access to the sensitive medical records of patients. A recent example is OpenAI’s partnership with the University of California, San Francisco health system, which will integrate a version of ChatGPT for Healthcare with patient records in Epic. WP Intelligence Lead Health Care Analyst Rebecca Adams looked more into the growing trend, which is the subject of her latest report. → The aim of these partnerships is to help doctors sift through medical histories, clinical notes and medical research faster, potentially providing clinicians information they don’t have time to assemble themselves. ChatGPT for Healthcare, which is used by medical professionals, shouldn’t be confused with the consumer-facing ChatGPT Health chatbot launched earlier this year. (The Washington Post has a content partnership with OpenAI.) (Unlike ChatGPT Health, OpenAI says ChatGPT for Healthcare is only available in workspaces that comply with federal laws governing medical record privacy — and the concerns about gaps in safeguards of patient information on the consumer-facing products are a whole other thing.) BEHIND THE PARTNERSHIPS - Boston Children’s Hospital uses a variety of AI technology tools under privacy-protected conditions, including an internal tool built with ChatGPT. The hospital is also piloting the newer ChatGPT for Healthcare program.
- “Those things are going to become more and more inextricably linked over time,” John Brownstein, senior vice president and chief innovation officer at Boston Children’s Hospital, told Rebecca.
Newer systems are moving beyond administrative tasks such as transcription and prior authorization and toward tools that can synthesize medical information and potentially influence clinical decisions. Garrett Adams, Epic senior vice president of research and development, says that the benefits of these tools can include helping clinicians avoid medical errors and guiding operational efficiencies such as how to schedule infusion treatments. - “But there are also some things that could go wrong,” Adams told Rebecca. “I think it’s very important in how we design these tools … at a core level to ensure that they behave appropriately, and also that health systems have some ability to set some of those guardrails or influence some of that trust-and-safety layer.”
Health systems say they can put guardrails around the technology. - Memorial Sloan Kettering Cancer Center in New York is using ChatGPT for Healthcare under a limited one-year trial that includes encryption protection, access controls and other oversight so that OpenAI can’t train its model on its data. Clinicians at the facility use AI for suggestions, but “the licensed clinician remains responsible for medical decisions.”
- “The goal is not to pretend the model is perfect,” said Ophelia Chiu, the center’s vice president of strategic innovation. “The goal is to design systems where imperfection does not create patient harm, and where accountability stays with the clinical team.”
But privacy advocates argue existing protections aren’t enough, arguing that the federal Health Insurance Portability and Accountability Act (HIPAA) — the federal law governing health record privacy — is outdated and too narrow for tech-based companies that have a tendency to prioritize speed over safety. “It is an absolutely worthwhile goal to have people more fully participate in their health services, and to have technology that serves us and improves our health,” said Sara Geoghegan, senior counsel at the nonprofit Electronic Privacy Information Center, calling the technology “unproven” and potentially riddled with privacy risks. “The onus really is on these companies to build and demonstrate trust for any potential positive outcome,” she added. “And they have repeatedly failed to do that.” → The stakes are growing as health systems figure out how much control patients should have over whether their medical records are used by AI systems — and a larger debate swirls about how much power AI companies should have overall. Read the full report: “Tech companies are pushing AI in medical records. Here’s what to expect.” “Kennedy to deliver keynote for anti-vaccine group he once led,” reports Isabella Cueto at STAT. “HELP Chair Plans Surprise Billing Roundtable for Next Week,” Victoria Knight reports at Bloomberg Government. “Montana’s giving the biotech industry sweeping authority to sell unapproved drugs,” Amanda Chu, Hilary Brueck and Andreas Macho report at Politico. “Wiping out measles impossible due to vaccine hesitancy in rich countries, says Gates,” Jennifer Rigby reports at Reuters. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from The Washington Post newsroom. Learn more about WP Intelligence. |