Not such a ‘clean’ resolution

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Oct 03, 2023 View in browser   By Ben Leonard and Chelsea Cirruzzo Presented by Driving the Day Sen. Ben Cardin said he will keep pushing for a five-year renewal of PEPFAR, the country’s global HIV-AIDS initiative. | Francis Chung/POLITICO PATH FORWARD FOR EXPIRED PROGRAMS — The deal to keep the government running kept health care agencies’ doors open, but it didn’t address a number of programs lawmakers hoped to extend. Despite averting a government shutdown, Congress let key health programs expire, including the SUPPORT Act tackling the opioid epidemic, the U.S. President's Emergency Plan for AIDS Relief known as PEPFAR and the Pandemic and All-Hazards Preparedness Act. Lawmakers could try to reauthorize the programs in a potential spending deal ahead of a Nov. 17 deadline to fund the government, but their specific path forward isn’t yet apparent. It’s unclear what the immediate practical consequences will be. PEPFAR has become embroiled in the battle over abortion. PEPFAR money will continue since the government has remained funded, but there’s no clear way forward for reauthorization. New Senate Foreign Relations Chair Ben Cardin (D-Md.) has said he’ll push for a five-year renewal, though some Republicans have wanted a one-year funding patch. George W. Bush has been trying to protect the program he helped craft in 2003 that’s been credited with saving 25 million lives. The program will continue to be funded, but supporters say that without a long-term commitment, groups fighting HIV and AIDS worldwide will struggle to hire staff and launch long-term projects. The SUPPORT Act, a major 2018 law, funded opioid use disorder prevention, recovery and treatment. The House Judiciary Committee advanced its SUPPORT Act reauthorization bill last week with an amendment to schedule the horse sedative known as tranq to Schedule III for three years as opposed to permanently — which the Energy and Commerce Committee’s version did. Funding for its programs will continue, but lawmakers must pass a reauthorization bill to make changes, like rescheduling tranq. Some Medicaid plan options allowing for residential treatment for substance use disorder also expired, leaving states searching for funding elsewhere. PAHPA, the more-than-16-year-old pandemic and emergency preparedness law, also saw most of its programs expire. The legislation historically has been bipartisan, but the Republican-controlled House advanced a smaller package than the Democratic-controlled Senate did, which set up a showdown between the two versions. The Senate’s version mandates that the government study long Covid and aims to address drug shortages, which Democrats in the House wanted to see in their chamber’s version. WELCOME TO TUESDAY PULSE. Digital health venture funding is continuing to fall, according to the latest data from Rock Health, establishing a “new normal.” Reach us with tips, feedback and news at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo. TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with Ben, who breaks down what will happen to health care agencies and programs now that a continuing resolution will keep the federal government open through Nov. 17. Listen to today’s Pulse Check podcast   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.   At the Agencies The CDC recommends in proposed guidelines that the antibiotic doxycycline be used to prevent sexually transmitted infections. | Rich Pedroncelli/AP Photo NEW CDC STI GUIDELINES — The Centers for Disease Control and Prevention proposed new rules for using antibiotics to prevent bacterial sexually transmitted infections in a Federal Register notice Monday. The protocols aim to expand access to post-exposure prophylaxis with the antibiotic doxycycline as a way to tackle gonorrhea, syphilis and chlamydia. The drug would be taken within three days of unprotected sex and offered to men having sex with men and transgender women with at least one previous bacterial STI in the past year. The agency said that doxycycline PEP could also be considered for men having sex with men and transgender women who hadn’t been diagnosed with an STI in the past 12 months but plan to engage in activities that increase the likelihood of exposure. The CDC added that using the treatment in other populations “should be effective,” but evidence is limited. An NIH-backed study this year found that the regimen led to a two-thirds reduction in STI infection. The broader context: STD rates are at record levels after worsening during the pandemic, and public health officials are looking for new ways to tackle the issue. What’s next: The CDC is taking comments for 45 days. The treatment’s potential impact on antibiotic resistance needs to be “closely monitored” after guidelines are implemented. CDC’S PICK FOR WASTEWATER SURVEILLANCE — The CDC is partnering with Alphabet subsidiary Verily to support its wastewater pathogen surveillance efforts, the company said Monday. The firm’s technology will be used for up to five years in a $38 million deal to monitor pathogens that cause diseases like Covid-19 and mpox with the goal of improving interventions. Wastewater surveillance has been an early warning system, but recent research has shown it’s become less effective over time. However, researchers have said it’s the most consistent way to gauge infection rates as at-home testing becomes ubiquitous and the end of the public health emergency limited CDC’s data authorities.   DOWNLOAD THE POLITICO APP: Stay in the know with the POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID.     Medicare WATCHDOG TO CMS: DO MORE ON BIOSIMILARS — Biosimilar competition has driven down costs in Medicare, but CMS could do more to spur savings, a watchdog report released Monday found. The HHS’ Office of Inspector General examined the prices and costs related to biosimilars — which aren’t meaningfully different from FDA-approved biologics and are often cheaper — in Medicare Part B from 2015 to 2021. The watchdog found that biosimilars and the associated biologics’ prices generally both fell after biosimilars were introduced. However, the OIG said that if biosimilars had been used more often, Part B spending could have fallen by $179 million, or 4 percent, in 2021. And basing payment on the lowest-cost drug could have cut spending by $419 million in 2021. CMS’ response: CMS didn’t agree or disagree with the recommendation explicitly, OIG said, but the agency said it’s “committed to taking action, as appropriate, within its authority.”   A message from PhRMA:   Global Health NEW MALARIA VAX — The World Health Organization recommended a new vaccine, R21/Matrix-M, to prevent malaria in children on Monday, POLITICO’s Carmen Paun reports. It’s expected to be cheaper and available in larger supplies than the first malaria vaccine from drugmaker GlaxoSmithKline, which the WHO recommended two years ago. The data: The new vaccine reduced symptomatic malaria cases in the year following a three-dose vaccination series by 75 percent in areas with highly seasonal malaria transmission, the WHO said Monday. A fourth dose given a year after the third shot maintained efficacy. What’s next: The WHO is expected to give the vaccine a formal regulatory endorsement that would allow Gavi, the vaccine alliance backed by wealthy nations, to procure shots for the low-income countries it supports.   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.     Names in the News Howard Levine and Jennifer Swan are joining Hogan Lovells’ life sciences patent litigation team. Both were previously of Dechert. Stephen Northrup, formerly of Rampy Northrup, is joining Global Medical Response as senior vice president of government affairs and public policy. WHAT WE'RE READING The Wall Street Journal reports that more than 4 in 5 emergency departments aren’t certified to treat kids. Kevin Frazier argues in the San Francisco Chronicle that going too far on artificial intelligence regulations could make the technology more dangerous.   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.      Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Evan Peng @thepngfile Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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