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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Sarah Owermohle and Adam Cancryn | Presented by |  | | | With Dan Goldberg, Rachel Roubein and Alice Miranda Ollstein Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.
| | | — Federal health officials knew about problems at a vaccine plant well before it ruined 15 million doses of Johnson & Johnson vaccine. — Billions of dollars in new funding is arriving too late for the many contact tracing programs that have already fallen behind in tracking Covid cases. — The Biden administration is unwinding Medicaid work requirements in two more states, as it slowly works to wipe out a major Trump-era health policy. WELCOME TO WEDNESDAY PULSE — where Ohio Gov. Mike DeWine has now been vaccinated twice on camera, 66 years apart (but wearing the same style glasses in both). Tips and vax pics to sowermohle@politico.com and acancryn@politico.com. | | | | A message from PhRMA: Nearly 50% of total U.S. spending on brand medicines goes to entities other than the manufacturers who make medicines. By focusing on list prices, cross-country price comparisons ignore the close to $200 billion in rebates, discounts and savings negotiated by insurance companies, PBMs, the government and others in the complex U.S. pharmaceutical supply chain. Learn more. | | | | | | THE TROUBLE STARTED MONTHS AGO — Both Trump and Biden administration officials knew that there were oversight and quality assurance problems at Emergent BioSolutions’ Baltimore plant as far back as last summer, Erin Banco and Sarah write. Emergent is churning out millions of doses of Johnson & Johnson’s vaccine, and until recently was contracted to supply millions of AstraZeneca’s shots as well. A June report shed light on early concerns that the company’s plan for manufacturing urgently needed Covid-19 vaccines was inadequate. Penned by a government official, it also noted that Emergent’s problems hiring and retaining skilled workers meant that it could not guarantee success in producing the shots, two people familiar with the report said. Trump administration officials met several times with representatives of Emergent and Johnson & Johnson after the report. Later, staff, some of whom still work for the government, gave the document and other key Operation Warp Speed files to the Biden team during the transition. The saga raises questions about whether pharmaceutical companies or the federal government could have done more to prevent the wasted doses and highlights the degree to which the country is depending on a limited pool of manufacturers to vaccinate every American. Emergent’s persistent production problems were first revealed by the New York Times. The company declined to comment for POLITICO’s story. J&J's vaccine supply will remain spotty for a while in the meantime, POLITICO's Rachel Roubein reports. The administration plans to send just 1.5 million J&J shots to states next week, down from the 11 million being delivered this week. FUNDING BOOST MAY NOT FIX CONTACT TRACING PROBLEMS — Beleaguered state and local coronavirus contact tracing programs are about to get nearly $50 billion for testing and tracing from Congress. But that likely won’t be enough to overcome the latest surge of cases, reporting gaps and other complications that now make it all but impossible to quickly track chains of transmission, write Alice Miranda Ollstein and Dan Goldberg. Tracers — overwhelmed already — struggle to track contacts and make sure those people get tested and self-isolate. At the same time, at-home Covid-19 tests are becoming more prevalent, increasing the chances that people won’t report positive tests to their local health authorities. But the stakes are still high. The emergence of more contagious variants means the virus can spread even faster. And conspiracy theorists continue to raise fears on social media about the government using tracers as an excuse to vacuum up personal health information. Even as governors continue rapidly lifting remaining coronavirus restrictions, most public health experts agree that tracing will be essential to tamp down clusters of infection once the pandemic starts to ebb.
| | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | BIDEN UNWINDS WORK REQUIREMENTS IN 2 MORE STATES — CMS notified health officials in Michigan and Wisconsin on Tuesday that it was withdrawing its permission to let those states require some Medicaid enrollees to work, volunteer or attend school as a condition of health coverage, Rachel reports. Both states’ Democratic governors inherited the work requirement from their Republican predecessors and had previously sought to block the policy. Neither state sent a letter to CMS defending the mandate after the Biden administration made clear its intent to unravel the work rules. A CMS spokesperson pointed to the pandemic’s likely long-term impact on the economy as a reason for dismantling the mandate, saying in a statement that Medicaid’s “primary objective” is to “provide medical assistance to our nation’s vulnerable and low-income individuals and families based on need, not one’s ability to find work.” Flashback: Last month, the administration rescinded Medicaid work requirements in Arkansas and New Hampshire, two states that once sought to defend the policy before the Supreme Court. The justices are still debating whether to take up the case, and only Arkansas is still fighting to keep the work requirements. — Yet Biden health officials have not yet officially decided whether to revoke similar Medicaid work rules in other Republican-dominated states. And some, such as Georgia, have indicated that they would challenge such a move by the White House in court. | | | FIRST IN PULSE: HOUSE COVID PANEL TO HOST BIDEN HEALTH OFFICIALS — The House Coronavirus Crisis Subcommittee will hold a hearing on April 15 with CDC Director Rochelle Walensky, White House medical adviser Anthony Fauci and HHS chief science officer David Kessler, Alice scoops. The hearing — titled “Reaching the Light at the End of the Tunnel” — will be the first the oversight panel has held with health officials from the Biden administration. Until now, the panel’s activity has almost exclusively focused on investigating wrongdoing by the Trump administration and the private companies with which it contracted to manufacture pharmaceutical ingredients and personal protective equipment. | | | ARKANSAS THE FIRST TO BAN GENDER-AFFIRMING CARE TO MINORS — A bill to bar doctors from providing gender-affirming care to transgender children will go into effect after the state’s legislature overrode Republican Gov. Asa Hutchinson’s veto, POLITICO’s Dan Goldberg reports. The measure is the nation’s first, and prohibits everything from puberty blockers to gender-affirming surgery – a sweeping restriction that LGBTQ advocates and local physicians argue will physically and psychologically harm hundreds of transgender youth. — What’s next: The ACLU is vowing a lawsuit to prevent the law from taking effect, saying Tuesday that it is “not only wrong, it’s also illegal.” But other states are moving in a similar direction, with the Alabama House set to take up a measure making it a felony for doctors to provide gender-affirming care to minors, punishable by up to 10 years in jail. The state’s Senate has already approved that bill along partisan lines. | | | |   | | | | | | DEMOCRATS SEEK ANOTHER OBAMACARE TWEAK — A group of Democratic committee chairs are asking HHS Secretary Xavier Becerra to let laid-off Americans sign up for Obamacare plans through a special enrollment period as soon as their employer-based coverage expires. In a Tuesday letter, the lawmakers warned that those who take advantage of the extended workplace benefits provided under Congress’ Covid aid bill could end up locked out of getting insurance through the Affordable Care Act until 2022 if not granted special access ahead of time. “We urge you to identify the loss of COBRA premium assistance as a triggering event that entitles individuals to access affordable Marketplace coverage,” House Energy and Commerce Chair Frank Pallone (D-N.J.), Ways and Means Chair Richard Neal (D-Mass.), Education and Labor Chair Bobby Scott (D-Va.) and Senate HELP Committee Chair Patty Murray (D-Wash.) and Finance Committee Chair Ron Wyden (D-Ore.) wrote. | | | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST" NEWSLETTER: Power dynamics are shifting in Washington and across the country, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is our twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear from important new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | HOUSE DEMS WANT OPIOID CRISIS DECLARATION EXTENDED — Four House Democrats on Tuesday urged Becerra to extend and broaden HHS’ declaration of the opioid crisis as a public health emergency, pointing to the steep rise in overdose deaths during the pandemic. The existing emergency declaration is set to expire on Wednesday. But Reps. Ann Kuster of New Hampshire, David Trone of Maryland and Nanette Barragán and Katie Porter of California argued in a letter that the record-high overdose figures over the past year justify expanding it from opioids to encompass the entire drug epidemic. | | | Rebecca Case will join MITRE as a health program analyst. Case was previously the senior director of Medicaid policy at America’s Health Insurance Plans. Claire Brandewie was named Sanofi’s senior director for federal government relations. She was a BIO lobbyist as a former aide to Sen. Tim Scott (R-S.C.). | | | | A message from PhRMA: Looking at differences in medicine prices between the United States and other countries can be misleading, often ignoring complexities in the U.S. system and the repercussions of other countries’ reliance on government price setting policies. As the discussion unfolds, here are a few often overlooked facts:
• Americans have the most robust access to lifesaving medicines in the world.
• Americans benefit from robust generic competition.
• The world benefits from U.S. global leadership in biomedical innovation.
• Negotiations between pharmaceutical companies and payers drive down prices, but patients don’t always pay less.
• We need smart, patient-centered solutions for lowering drug costs.
Learn more. | | | | | | Florida Gov. Ron DeSantis has issued an order banning businesses from requiring so-called vaccine passports for entry, but the Republican National Committee will still require attendees of its donor retreat in Mar-a-Lago prove they tested negative for Covid before entry, the Washington Examiner’s David Drucker reports. Vaccine contracts negotiated by the Trump administration are preventing the U.S. from easily sharing surplus doses with the rest of the world, Vanity Fair’s Katherine Eban reports. Decades of neglect and underfunding laid the groundwork for the severe wave of Covid cases that hit New York nursing homes during the pandemic’s first months, New York Magazine’s Bridget Read writes. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
