| | | | |  | | By David Lim and Lauren Gardner | Presented by Pharmaceutical Care Management Association | | | | | | 
Rep. Jason Smith, chair of the House Ways and Means Committee, wants to see more Medicare coverage for weight-loss drugs. | Francis Chung/POLITICO | MEDICARE COVERAGE IN THE SPOTLIGHT — House lawmakers on the Ways and Means Committee overwhelmingly advanced four bills Thursday that would open the door to Medicare covering weight-loss drugs for a limited group of beneficiaries and provide four years of automatic coverage of breakthrough medical devices that get a green light from the FDA. The catch? The cost to cover weight-loss drugs for all Americans on Medicare caused the tax-writing body to dramatically narrow the expansion. The committee advanced the bill by a 36-4 vote. If enacted, the bill would affect new Medicare beneficiaries who already had a non-Medicare plan covering the medicines and a prescription at least one year before enrolling in the federal health program. But lawmakers on both sides of the aisle, including Ways and Means Chair Jason Smith (R-Mo.), described the bill as a first step toward expanding Medicare coverage of increasingly popular weight-loss drugs. “I would like to see broader coverage,” Smith said. “I also would like to point out that this bill has been around since 2013, and this is the farthest it has ever went. ... If we wait on perfect here, we will wait another 11 years.” The next step for the bills remains unclear — but an end-of-the-year health package in the lame-duck period after the election continues to be batted about as a potential vehicle for getting the legislation passed. The House Energy and Commerce Committee also shares jurisdiction over health legislation, meaning disagreements between the two committees will need to be ironed out. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. FDA Commissioner Robert Califf continues to warn that poor health for American men is causing substantial economic fallout. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
| | A message from Pharmaceutical Care Management Association: Employers need and value flexibility when it comes to their health care benefits. That's why employers rely on pharmacy benefit managers (PBMs) to provide a wide range of options that help them offer high-quality, cost-effective benefits, saving an average of $1,040 per person each year. And why PBMs are innovating to provide employers new offerings, including new ways to leverage data and additional options to reimburse pharmacies and contract for services. Hear Joseph’s story. | | | | | | | 
Former President Donald Trump and President Joe Biden debated who was responsible for lowering insulin prices. | Francis Chung/POLITICO | AT THE DEBATE — Former President Donald Trump said he brought down insulin prices for seniors, but his claim in Thursday’s debate is largely misleading.
"I am the one who got the insulin down for the seniors," Trump said. The Inflation Reduction Act, which President Joe Biden signed into law, caps insulin co-pays for Medicare patients at $35 a month. It's something Trump has previously attempted to take credit for, signaling that he sees the policy as a potential vulnerability with some voters. His administration had a voluntary program, but Biden’s action is significantly broader. Biden responded that his insulin policy, which has been broadly popular, was more expansive. Still, Biden, whose performance was assailed in post-debate analysis, mixed up his numbers on the legislative cap on out-of-pocket prescription drug costs as well as the cost of insulin in Medicare.
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The CDC endorsed its advisory committee's recommendation Thursday for an updated Covid-19 vaccine for nearly all Americans. | Pool photo by Eduardo Munoz | CDC ADVISERS ENDORSE COVID SHOT — The CDC’s independent vaccine advisers recommended an updated Covid-19 vaccine Thursday for anyone 6 months or older, laying the groundwork for the shots to be shipped to pharmacies and health care providers later this year. CDC Director Mandy Cohen endorsed the recommendation hours later. The FDA must still approve or authorize the updated formulas from Pfizer, Moderna and Novavax. But once the agency does — and the CDC director formally recommends their use — manufacturers will begin distribution to providers that can administer the shots. Warning dollar signs: Despite the universal recommendation, some members of the Advisory Committee on Immunization Practices expressed concern about the vaccines’ cost-effectiveness, particularly for younger people who aren’t as high risk for serious complications from the disease compared with adults 65 and older. “On balance, I’m in favor of the universal recommendation, but if I’m just facing this individual decision right now, the cost-effectiveness of the younger children is concerning to me,” said Jamie Loehr, a committee member and owner of Cayuga Family Medicine in Ithaca, New York. According to the ACIP, Covid vaccines are about five times more expensive than flu shots that are recommended annually for the same age groups. ACIP members called on vaccine makers to consider the impact of their products’ prices on consumers, especially those who are un- or underinsured and will soon be without a federal program offering free Covid shots.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | WARREN, CARTER SLAM EXPRESS SCRIPTS — A group of 24 bipartisan lawmakers led by Rep. Buddy Carter (R-Ga.) and Sen. Elizabeth Warren (D-Mass.) is raising alarm over Express Scripts’ TRICARE pharmacy program contract with the Defense Health Agency. “We believe DHA’s exclusive contract with Express Scripts may be harming TRICARE beneficiaries, independent pharmacies, and American taxpayers,” the lawmakers wrote to Dr. Lester Martinez-Lopez, assistant secretary of Defense for Health Affairs, and Lt. Gen. Telita Crosland, director of the Defense Health Agency. They contend that the company unfairly used its market power to direct beneficiaries to its own mail-order pharmacy. A spokesperson for Express Scripts said the contract has saved billions for taxpayers and the government. “TRICARE beneficiaries have access to the full range of generic, brand, and specialty medications on the market today through our robust network of chain, independent, military, specialty and home delivery pharmacies,” the company spokesperson said.
| | | | SCOTUS KILLS PURDUE SETTLEMENT — The Supreme Court rejected a nationwide settlement with OxyContin maker Purdue Pharma on Thursday, ruling that the deal inappropriately shielded the Sackler family that owns the company from civil liability over the effects of the opioid epidemic. The 5-4 high court decision upends the deal, which would have directed billions of dollars to drug treatment efforts and families of those affected by the opioid crisis. In his dissent, Justice Brett Kavanaugh urged lawmakers to weigh in on whether the bankruptcy system’s legal shield should apply. “Opioid victims and other future victims of mass torts will suffer greatly in the wake of today’s unfortunate and destabilizing decision,” he wrote. “Only Congress can fix the chaos that will now ensue.”
| | | | THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.
Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY. | | | | | | | | | DIVERSITY PLAN GUIDANCE LANDS — The FDA released its draft guidance for trial diversity action plans Wednesday, nearly six months past a congressionally mandated deadline. The long-awaited document aims to help drug and device makers ensure greater representation in race, ethnicity, pregnancy status and other factors in clinical trials. It urges companies to consider the estimated prevalence of the condition they’re seeking to treat among different populations when setting enrollment goals for trials. The agency will take comments for 90 days. Meanwhile, GSK is already touting the work it’s done to bolster diversity across its clinical studies. “For the past two years, all of our Phase III trials have had diversity plans consistent with disease epidemiology before enrollment,” Michel Reid, GSK’s head of global demographics and diversity, said in a statement. “This year, we have set a target of enrolling the communities represented in these plans in at least 50% of our trials finishing enrollment in 2024.” FIRST POINT-OF-CARE HEP C TEST — Doctors will be able to diagnose hepatitis C in an hour using a fingertip blood sample rather than having to send a sample to a laboratory. The FDA authorized the first point-of-care test for the disease Thursday, meaning that fewer patients will need follow-up appointments that can result in a delay or prevent a diagnosis. The test, made by Cepheid, could help the roughly 2.4 million people in the U.S. estimated to have hepatitis C. “Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
| | | | SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRIBE NOW. | | | | | | | | | CMS published its proposed rule for the calendar year 2025 end-stage renal disease prospective payment system. The Federal Trade Commission updated a final rule Thursday requiring eye doctors to obtain signed confirmations after they give copies of eyeglass prescriptions to patients and to maintain the documents for at least three years. Patients sometimes used copies of their prescriptions to purchase eyeglasses elsewhere. The FDA and U.S. Customs and Border Protection said Thursday they seized more than $1 million worth of unauthorized e-cigarette products intended for a Mississippi-based wholesaler. The FDA released a report Thursday on submissions to the agency’s drug and biologics centers containing real-world evidence analyses. OptumRx agreed to pay $20 million to settle allegations it improperly filled opioid prescriptions between April 2013 and April 2015.
| | A message from Pharmaceutical Care Management Association: PBMs are working every day on behalf of employers, helping them provide high-quality, cost-effective prescription drug coverage to employees and their families.
According to a recent national survey of employers:
● 97 percent are satisfied with their PBM;
● 89 percent say their PBM is valuable in helping their organization offer affordable benefits to employees;
● 93 percent say it is essential to have flexibility and a range of choices in how they offer prescription drug benefits to employees;
● 86 percent say it is important to have a range of options in how they pay PBMs for their services and expertise.
Without PBMs, employers would have to go it alone, without the flexibility, savings, leverage or dedicated expertise to navigate the prescription drug marketplace.
Hear employers’ stories about how their PBM works for them. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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