| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | | | With Robert King and Marcia Brown
| | |  Rep. Frank Pallone was dismayed that an act to extend funding for outreach to low-income Americans wasn't brought up by the House E&C Committee on Thursday. | Francis Chung/POLITICO | A ROCKY START — Lawmakers in the House Energy and Commerce Committee took the first step Thursday to address longstanding issues with how much Medicare should pay doctors, Robert reports. But the chaos in the House in choosing a new speaker and the friction between the two parties during a subcommittee hearing makes a wholesale reform effort appear unlikely this year. Background: Since June, the committee has weighed proposals on the Medicare formula used to pay doctors, who say the payments aren’t keeping pace with practice costs, forcing them to shut down or consolidate with hospitals. Democrats on the panel were livid Thursday that some legislation wasn’t included in the 23 bills highlighted at the hearing. “My Republican colleagues shared a vast majority of the discussion drafts we will be discussing less than a week before the hearing was noticed,” said Rep. Frank Pallone of New Jersey, the top Democrat on the committee, during the hearing. “Many of these drafts are still half-baked.” Pallone was irate that Republicans didn’t include the Helping Low-Income Seniors Afford Care Act , which seeks to extend funding for outreach to low-income older Americans. Rep. Anna Eshoo (D-Calif.) added that nearly half of the bills are “either in discussion draft form or only formally introduced a week ago.” Republicans argue that the Biden administration is part of the problem because rising inflation has exacerbated costs for practices. Committee Chair Cathy McMorris Rodgers (R-Wash.) added that there were no hearings for the past four years on the issue. Some draft bills included in the hearing focused on changing the payment formula CMS uses to calculate physician payments. CMS proposed a more than 3 percent cut to Medicare payments for 2024, the latest in a series of cuts due partly to budget neutrality rules. Other legislation sought to rein in the use of prior authorization by Medicare Advantage plans, a cost containment tool that requires doctors to get insurer approval before prescribing a drug or performing a service. WELCOME TO FRIDAY PULSE. Did this week feel longer than usual for anyone else? Send your tips, scoops and feedback to bleonard@politico.com and ccirruzzo@politico.com and follow along @_BenLeonard_ and @ChelseaCirruzzo. TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with POLITICO health care reporter Katherine Ellen Foley about the FDA's accelerated approval process for neurological disease treatments and why some experts fear it can result in giving patients false hope.
| | | | A message from PhRMA: PBMs are siphoning money away from you. They decide what you pay and what medicines you can get. PBMs steer you toward pharmacies they own that make them more money. And, they’re creating new fees that pad their profits, but don’t benefit patients. Learn more. | | | | | | | | | | 
The FDA is creating a new office to prevent another baby formula shortage. | Brandon Bell/Getty Images | NEW FDA FORMULA OFFICE — The Food and Drug Administration will create a new office to specifically tackle the challenges revealed in the infant formula crisis last year, said Jim Jones, the FDA’s first deputy commissioner for human foods, In a memo sent Thursday, he laid out his vision for strengthening the agency’s Human Foods Program, Marcia reports. The office was previously announced as part of the FDA's program redesign. “As part of this work, the FDA is working to incentivize redundancy and resiliency of the infant formula supply chain infrastructure over the long term and work with manufacturers to help ensure they are taking all appropriate steps to manufacture products safely to avoid the need for recalls and shutdowns,” wrote Jones. Other priorities: Jones identified several other key areas, including decreasing the incidence of diet-related chronic diseases, preventing acute foodborne illness and reducing consumers’ exposure to contaminants or other harmful chemicals in food such as by regulating dietary supplements and other food additives. Soon-to-come: The FDA is exploring front-of-package labeling, which proponents say will promote healthy eating, and plans to host listening sessions next month. The FDA also has listening sessions planned for “strategies to reduce consumption of added sugars” and a series of Tribal listening sessions on food sovereignty and equity. MURKY METRICS — In the last seven years, the FDA has used its accelerated approval pathway to bring several drugs to treat neurological diseases to market, some of which were the first treatments of their kind. But some experts fear this pathway — intended to get patients without options earlier access to new drugs — might not be helping patients, POLITICO’s Katherine Ellen Foley reports.
|  | Accelerated approval hinges on proxy metrics in clinical trials. If manufacturers can show that a new treatment improves a proxy metric, or an alternative metric, thought to indicate its benefits in an earlier clinical trial, the FDA can conditionally approve it to get it to patients sooner. For conditions like HIV or cancer, proxy metrics are often good predictors of a drug’s merit. But proxy metrics for neurological conditions are far murkier. No relationships have been clearly established between some of these metrics and patient improvement down the line. Drugmakers must conduct additional trials to prove accelerated approval therapies work after they reach the market or risk their approval being revoked. But the trials can take years to complete and are often delayed. Congress recently granted the FDA additional powers to pull unproven drugs from the market if manufacturers fail to provide more evidence quickly. But the agency hasn’t fully put these powers into motion. Patients without other options see these drugs as their only hope. Many of the diseases they treat are so rare and fatal so quickly, it would be impossible to run a traditional clinical trial, said Paul Melmeyer, vice president of public policy and advocacy at the Muscular Dystrophy Association.
| | | | A message from PhRMA:   | | | | | CHILD CARE FUND ASK — The Biden administration is expected to send Congress a funding request for domestic priorities next week, according to three people familiar with the request, POLITICO’s Jennifer Haberkorn, Adam Cancryn, Caitlin Emma and Jennifer Scholtes report. The ask will come in addition to the White House’s anticipated national security emergency spending request. The domestic policy request is slated to include funding for child care, broadband and disaster relief and is likely to gain far less traction with Republicans on the Hill than its counterpart. The people who confirmed the timing of the funding requests — expected to cover one year — stressed that they are subject to change. Progressives have called for a funding pitch from the White House that would include both foreign and domestic spending — arguing that while constituents care about aiding Ukraine and Israel, they also need support at home. However, Republicans will likely balk at the request’s expansive child care spending and other domestic priorities. A group of progressive senators, including Sen. Tina Smith (D-Minn.), have pushed the Biden administration to add the child care funding, which would fill the void left when pandemic-era federal aid for child care expired on Sept. 30. They’ve based their request on the approximately $16 billion that was provided annually during the pandemic. Some Democrats want the president to ask for extra cash to bolster other at-home priorities, such as funding for science programs like AI and quantum computing efforts authorized under the CHIPS bill Biden signed into law last year.
| | | | GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is proud to partner with the Milken Institute to feature a special edition of our Future Pulse newsletter at the 2023 Milken Institute Future of Health Summit from November 6-8. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators solving the biggest public health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE. | | | | | | | | | MEDICAL RECORDS ON YOUR PHONE — Last year, 3 in 5 individuals nationwide were offered, and able, to access their medical records — up 50 percent since 2020, the Office of the National Coordinator for Health Information Technology said in a new report. Why it matters: The report out this week highlights the rise in the use of apps to access medical information in the wake of the implementation of the Cures Act, which, among its provisions, expanded patient access to electronic health records through apps. The data, from the 2022 Health Information National Trends Survey, found that 57 percent of individuals accessed their online medical records or patient portal at least once in the past year, also a 50 percent increase from 2020. Per ONC, the use of apps to access medical records rose between 2020 and 2023, while access to web-only portals decreased. The most common uses of the online medical records were to view test results and clinical notes. However, while patients reported having medical information across a variety of portals, only 2 percent of patients used apps that could combine the records into a single portal.
| | | | Eric Lail is now the director of media and public relations at Centene. He previously was at Elevance Health.
| | | | A message from PhRMA: Health insurers and PBMs can refuse to share savings that should go to you. Now they’ve got another trick. A new report shows PBMs found new ways to profit off your prescriptions. They’ve doubled the amount of fees they charge on medicines in the commercial market. They tie these fees to the price of medicines. And experts warn this can lead PBMs to cover medicines with higher prices instead of lower-cost options. | | | | | | The Associated Press reports on efforts by Historically Black colleges or universities to collect more genetic material from people of African ancestry. STAT reports on the FDA’s 50-year-long battle to regulate food additives.
| | | | A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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