Device makers await CMS redo

Presented by the American Heart Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Apr 28, 2023 View in browser   By David Lim Presented by the American Heart Association With Katherine Ellen Foley CMS is expected to soon issue an overhaul of a program to speed Medicare coverage of medical devices. | Evan Vucci/AP Photo TCET WATCH — The medical device industry is poised to respond to a long-awaited proposal expected to be released as soon as today that would replace a Trump-era regulation giving four years of Medicare coverage to breakthrough medical devices approved by the FDA. President Joe Biden’s CMS repealed the Trump-era policy because of concerns it was too broad in November 2021. Now CMS is expected to float a voluntary program that is limited to devices relevant to Medicare patients. “It’s still April,” said Tamara Syrek Jensen, acting deputy director of CMS’ Center for Clinical Standards and Quality, when asked Thursday about the status of the anticipated proposal — known as Transitional Coverage of Emerging Technology. She made her remarks at the Medical Device Manufacturers Association’s annual meeting in Washington. Top CMS officials, including Chief Medical Officer Lee Fleisher and Principal Deputy Administrator Jonathan Blum, had previously indicated in JAMA that the agency was moving to issue a proposed rule. The Biden administration will issue a notice with less than a $100 million economic impact. But device makers had sought a proposed rule that would have a far greater economic effect. The change raised alarms among device makers that Biden’s CMS is not following through on its commitment to issue a proposed rule to replace the Trump-era regulation. “We do remain hopeful that CMS will act soon, but any further delay would not feel like a commitment to the Medicare patients who may be waiting for new, breakthrough treatments to help alleviate their suffering,” Scott Whitaker, CEO of device trade group AdvaMed, said in a statement. House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) told attendees at the MDMA meeting that lawmakers want to see what CMS issues before moving forward with legislation to tweak how breakthrough medical devices are covered. “We'll look at that rule and use that to inform what exactly should be in the bill,” Rodgers said. It’s Friday. Welcome to Prescription Pulse. Condolences to this heartbroken intern lamenting their love life in a Senate elevator. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Krista Mahr talks with host Carmen Paun about the findings in the CDC’s 2021 Youth Risk Behavior survey of high schoolers and the impacts the pandemic has left on teenagers’ mental well-being. Listen to today’s Pulse Check podcast   A message from the American Heart Association: For decades, the tobacco industry has used menthol cigarettes and flavored cigars to hook new users. The flavors attract youth and young adults, make cigarettes and cigars easier to smoke and make it more likely that experimental users will become regular users. Menthol also makes it harder to quit. One year ago, the FDA proposed ending the sale of these highly addictive, deadly products. Now it’s time for FDA to finish the job. Learn more.   In Congress LAWMAKERS UPSET ABOUT ALZHEIMER’S DRUG COVERAGE — Nearly a third of the members of the House Energy and Commerce Subcommittee on Health from both parties urged CMS Administrator Chiquita Brooks-LaSure to broaden coverage for the new Alzheimer’s drug Leqembi at her first appearance before Congress since being appointed two years ago, Katherine reports. The show of force demonstrates the political headwinds facing CMS as it weighs whether to broadly cover Leqembi and other drugs that potentially could cost Medicare billions in years ahead. “The one thing I can say both sides of us absolutely agreed on is that we need to work on the Alzheimer’s drug [Leqembi] and make sure that people have access as we move forward,” said Rep. Brett Guthrie, (R-Ky.), chair of the subcommittee. Lawmakers are upset that — as they see it — CMS’ limited Medicare coverage determination is irreconcilable with the FDA’s accelerated approval of the drug. But the two agencies have different mandates: Medicare coverage is limited to medical products that are deemed “reasonable and necessary,” while the FDA approves drugs and devices if there are data showing they are “safe and effective.” Lawmakers fear that even if the FDA grants Leqembi traditional approval, hospitals won’t be prepared to establish registries that meet CMS’ guidelines. Registries are private-sector databases that doctors update to track patient outcomes of drugs and devices. “Have you published any information to Alzheimer's patients and their families explaining how to get the drug under Medicare?” ranking member Anna Eshoo (D-Calif.) asked the CMS chief. “We will do so. But it's not done,” Brooks-LaSure said. Drug companies suspect that CMS coverage restrictions won’t last: On an earnings call on this week, Biogen executives said they think that CMS will be forced to reconsider its coverage after Leqembi receives traditional approval this summer. Lilly executives expressed a similar sentiment to a Reuters reporter last week. Sen. Peter Welch (D-Vt.) asks a question during a Senate Judiciary Committee hearing. | Mariam Zuhaib/AP Photo DEMS PUSH IRA EXPANSION — Nearly two dozen Democrat senators introduced legislation this week that would empower CMS to select drugs and biologics for Medicare price negotiations five years after FDA approval and increase the number of products that can be negotiated starting in 2026. Under current law, drugs can be selected into the program seven years after market entry and biosimilars after 11 years, and just 10 Medicare Part D drugs are subject to price negotiation for 2026. The legislation, led by Sen. Amy Klobuchar (Minn.), won’t be passed into law this Congress with Republicans controlling the House. But the broad Democratic support of the legislation shows many high-profile senators, including Elizabeth Warren (Mass.) and Patty Murray (Wash.), view expanding Medicare negotiations as a winning political message in 2024 despite strong opposition from the pharmaceutical industry. “A Republican House is going to continue to be resistant, but it is just an expression of continued support about the need to continue to accelerate and intensify” government drug price negotiations, said Sen. Peter Welch (Vt.).   HAPPENING NEXT WEEK! GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from May 1-4. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.     At the Agencies CALIFF WANTS DEVICE MAKERS TO WEIGH IN ON EtO — Top FDA officials told medical device executives on Thursday to weigh in on the Environmental Protection Agency’s recent proposed regulations to restrict the use of ethylene oxide, a carcinogenic gas used to sterilize approximately half of all sterile devices nationwide. The worry from industry is that if commercial sterilizers are forced to pause operations to upgrade emissions control equipment, the supply chain for critical medical devices will be disrupted and patients will suffer. The EPA proposal maintains that cutting emissions of ethylene oxide will result in fewer cancer cases. “Make your voice heard,” FDA Commissioner Robert Califf said Thursday at the MDMA conference. “This issue is very much on the forefront for us. We are highly aware of it and we're engaged in the discussions. I’m very worried.” Top medical device regulator Jeff Shuren said that the FDA respects the EPA’s mandate to protect human health and the environment, but said his agency is focused on making sure there won’t be shortages of critical medical devices as the industry implements compliance with the new rules. Rep. Rodgers told the medical device executives she is very concerned about the EPA’s proposed rule, and noted EPA Administrator Michael Regan is scheduled to testify before the Energy and Commerce Committee in May. “Unfortunately we’ve seen a number of extraordinary rules being proposed by the administration right now,” Rodgers said. “During Covid, it was magnified how vulnerable our supply chains are and it’s been a focus to secure the supply chains. Policies like this really will wreak havoc on access to care.”   A message from the American Heart Association:   Industry Intel Bluebird Bio is asking for priority review of its sickle cell disease gene therapy. | Sarah Silbiger/Getty Images ANOTHER GENE-EDITING THERAPY BEFORE THE FDA — Bluebird Bio said that it has asked the FDA to approve its gene-editing treatment for sickle cell anemia.   DON’T MISS THE POLITICO ENERGY SUMMIT: A new world energy order is emerging and America’s place in it is at a critical juncture. Join POLITICO on Thursday, May 18 for our first-ever energy summit to explore how the U.S. is positioning itself in a complicated energy future. We’ll explore progress on infrastructure and climate funding dedicated to building a renewable energy economy, Biden’s environmental justice proposals, and so much more. REGISTER HERE.     Tobacco BETTER TOOLS TO QUIT TOBACCO? — A team of smoking-cessation scientists and the Campaign for Tobacco-Free Kids published a perspective in this week’s NEJM, outlining ways the FDA could help pharmaceutical companies innovate better tools to help tobacco users quit. The paper posits that the FDA’s Center for Drug Evaluation and Research could consider whether new products are an improvement on existing nicotine-replacement therapies while not posing a risk to children who have never smoked. It also notes that CDER could proactively meet with drug developers to encourage innovation in the space. Quick Hits Eli Lilly unveiled clinical data on Thursday showing its weight-loss drug Mounjaro helped diabetes patients lose 15.7 percent of their body weight, STAT’s Matthew Herper reports.   A message from the American Heart Association: It’s time to stop the tobacco industry from profiting off products that kill. Almost half a million people in the U.S. die from smoking each year and 16 million people across the country are living with a smoking-related disease. Menthol cigarettes and flavored cigars are a big part of the problem. Big Tobacco uses menthol cigarettes and flavored cigars to attract and addict new smokers, aggressively targeting Black and Hispanic people and other communities of color, the LGBTQ+ community and youth. Last year the FDA took a historic step – proposing to remove menthol cigarettes and all flavored cigars from the market. A year has passed. Join us and tell FDA it’s time to finish the job. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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