| The Centers for Medicare and Medicaid Services will release updates on its approach to a pilot program that aims to test how the federal government can leverage technology to improve care and control costs, a top health official said on Wednesday. Stephanie Carlton, who serves as the deputy administrator and chief clinical AI officer at CMS, wasn’t specific about what the updates would be. However, she pointed to several questions the agency is mulling about that pilot — known as the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model — and a potential expansion of the pilot. “We have said that we want to announce more tracks and more opportunities to engage in that. So the team has been working very carefully on those additional tracks,” Carlton said at the Consumer Technology Association’s Health AI+ conference. The ACCESS model rolled out in July and is scheduled to continue over the next decade. Among the questions Carlton said CMS is asking are which regular data reporting requirements for Medicare models that involve health claims, outcomes and quality make sense — and which parts of those requirements may not. “At some level, we don’t want to build a whole quality-industrial complex around reporting,” Carlton said. “We want to have exactly what is necessary to make sure the technology is working and that we’re not causing harm — that it’s actually getting to a better-than-today standard for patients.” Why it matters: The ACCESS model represents the first time that traditional Medicare has covered wearable devices, apps, videos or other technology that helps older Americans with certain chronic conditions including obesity, chronic pain and mental health. Carlton described her role at CMS as focusing on how regulators can encourage technologies to improve health outcomes, and how to personalize what artificial intelligence can do for patients. It’s a new job at the agency, showing the Trump administration’s emphasis on incorporating artificial intelligence into both the federal workflow and the health care system more broadly — a position she says was spurred by CMS Administrator Mehmet Oz. Carlton said she works in tandem with Amy Gleason, who leads the U.S. DOGE Service and serves as a deputy administrator and chief product officer at CMS, who handles the technology and data portfolio, while she’s focused on the policy and regulatory side. The ACCESS model is “the first step toward a greater vision of, what is the role of AI in managing total costs of care that either holds quality constant or dramatically improves it — which I think it can,” Carlton said. She also emphasized the coordination that’s happening across the health department, including partnering the payment responsibilities that CMS has with the Food and Drug Administration’s purview over safety and quality. The FDA has a corresponding pilot program called Technology-Enabled Meaningful Patient Outcomes (TEMPO) that contracts with selected manufacturers and monitors treatment outcomes for certain devices targeting chronic illnesses. Those devices are used to provide care that’s covered under the ACCESS model. So far, four companies have been selected to participate: SonderMind, Limbic, Cadence Solutions and Dexcom. → On that note: The Department of Health and Human Services on Tuesday appointed Jared Seehafer as the deputy FDA commissioner for technology and artificial intelligence, a newly created role. He’ll set the priorities for the use of AI and other tech across the agency. In addition to testing how technology can improve health outcomes, the FDA has been moving toward putting AI in place across the agency — including in the hands of officials reviewing drugs — and it’s now created a role to oversee it. Seehafer, who has been a senior adviser at the agency for more than a year, has worked in venture capital and on medical devices, and has helped combination drug-device companies navigate the regulatory process. He also co-founded life-sciences compliance software company Enzyme, which was acquired by Greenlight Guru last July. As I mentioned briefly yesterday, HHS also picked permanent leads for the nation’s top drug and vaccine and biologic treatment regulators, elevating the two officials who’d been serving in those roles in an acting capacity. Michael Davis is now the permanent director of the Center for Drug Evaluation and Research (CDER), which oversees the nation’s prescription and over-the-counter drugs, and Karim Mikhail leads the Center for Biologics Evaluation and Research (CBER), which is responsible for approving new vaccines and biologic medications. The appointments have been well received by industry. “Both are well-liked leaders in the ‘back-to-normal’ effort at FDA, and permanently filling the positions now would preclude the next commissioner from bringing in more roguish leadership,” Rob Smith, a managing partner at Capital Alpha, writes in a note to investors. Smith said duo has “taken pains to stamp out” the policies implemented by former FDA leadership, including ex-commissioner Marty Makary, who stepped down in May, and Vinay Prasad, the polarizing former CBER head. This includes “dropping vaccine trial requirements and allowing several rejected drug applicants to try again,” Smith writes. → HHS has also selected Bret Koplow, who has been at FDA since 2011, to serve as director of the FDA’s Center for Tobacco Products. He’s been working in the position in an acting capacity since last spring. John E. Sununu is headed back to the Senate ballot. The former New Hampshire senator (and congressman) won the Republican primary Tuesday, setting up a November matchup with Democratic Rep. Chris Pappas for the seat being vacated by Sen. Jeanne Shaheen (D). Why it matters: The race is slightly competitive, with Cook Political Report rating it as a lean-Democratic. It’s a seat that Democrats will have to defend as they try to wrestle control back of the Senate. A recent poll showed Sununu beating Pappas by two points in a hypothetical head-to-head matchup, though the poll has a 2.3 percent margin of error. Sununu, who served in the Senate from 2003 to 2009, secured 68 percent of the support from Republican voters. He’s spent much of his time out of politics on corporate boards, including nearly two decades as a director of medical device giant Boston Scientific. Financial disclosure records show he most recently earned more than $444,000 from his role on the medtech company’s board, and holds between $5 million and $25 million in Boston Scientific stock tied to deferred compensation. | 
