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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 Ben Leonard and Daniel Payne | | | With Alice Miranda Ollstein and Carmen Paun
| | |  President Joe Biden's plan to protect abortion rights by expanding HIPAA protections isn't sitting well with conservatives and progressives. | Tasos Katopodis/Getty Images | TOO FAR OR NOT FAR ENOUGH? One of the Biden administration’s farthest-reaching efforts to protect abortion rights is drawing criticism from lawsuit threats from conservatives who view it as an unconstitutional overreach and progressives who see it as inadequate, Alice reports. The Department of Health and Human Services is preparing to release a final rule later this year that would expand the protections of the decades-old Health Insurance Portability and Accountability Act, or HIPAA, to better shield people who seek, obtain or provide abortions from red-state probes. The agency proposed the rule in April and opened it for public comment through mid-June. Like so many actions the Biden administration has taken in the year since Roe v. Wade fell, it’s been hit from all sides — and may end up in court. — Conservatives, including Republican attorneys general and former Trump administration officials, say the rule violates states’ rights and the Supreme Court’s Dobbs decision — and would be ripe for a lawsuit under the Administrative Procedures Act and the U.S. Constitution. — Meanwhile, nearly 50 Congressional Democrats say the rule doesn’t go far enough. In a letter to HHS Secretary Xavier Becerra shared first with POLITICO, they ask the administration to strengthen it by requiring law enforcement to obtain a warrant to access a patient’s abortion records. The proposed rule allows state officials to access this information if they get a subpoena or administrative request — a lower bar. As the agency preps the rules, the situation in states continues to change. Iowa moved to ban abortion after about six weeks of pregnancy last week, but on Monday, a judge temporarily blocked it. That means abortion is again legal up to 20 weeks as litigation continues. WELCOME TO TUESDAY PULSE. Where might the FTC be moving next in health care? Let me know at bleonard@politico.com. And don’t forget to send tips to Daniel Payne, your regular Pulse host, at dpayne@politico.com.
| | | | UNLEASH THE FUTURE OF HEALTHCARE WITH POLITICO, A 7/20 INTERACTIVE EVENT: Imagine a future where rare genetic diseases are not only treatable, but potentially curable. Where our approach to chronic illness takes a monumental leap forward. That future is already taking shape in the form of next-generation health care treatments such as gene therapy. Join POLITICO on Thursday, July 20 and delve into the burgeoning field of gene therapies, which hold the power to redefine our health care landscape. Are you ready to explore this new frontier in health care? Don't miss this chance to be part of the conversation. REGISTER NOW. | | | | | | | | | A message from PhRMA: Research and development of cancer medicines after their initial FDA approval can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. Read the new report. | | | | | POLITICO is hosting a health care event, The Next Generation of Health Care Therapies, on Thursday starting at 4 p.m. ET. Join POLITICO to dive deep into the landscape of future health care treatments like gene therapy and how they could reshape our current health care system. | | | TODAY ON OUR PULSE CHECK PODCAST, host Evan Peng talks with Ben, who breaks down CMS' proposed changes to Medicare’s physician fees, which the agency says would advance lower costs and support behavioral health — and the ensuing praise and criticism that the plan has garnered.
| | | | | LABOR-HHS BILL GETS A BOOST — Top Senate appropriators will pad out their fiscal 2024 spending bills with nearly $14 billion in additional emergency spending, including more funds for the Labor-HHS-Education bill, POLITICO’s Caitlin Emma reports. The Labor-HHS bill would get another $2 billion. Senate appropriators had previously set a topline funding figure of $195 billion, well above levels proposed by House appropriators. The extra emergency cash comes amid bipartisan concerns that the overall budget totals set by the debt ceiling deal would shortchange federal agencies for the coming fiscal year.
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The Labor Department will introduce new injury-documentation rules next year for health care providers that employ 100 or more workers. | Getty Images | NEW OSHA REQUIREMENTS — The Department of Labor will require large employers in high-risk industries — including health care — to electronically file injury and illness reports to the Occupational Safety and Health Administration starting next year, POLITICO’s Nick Niedzwiadek reports. Who it applies to: The rules will apply to organizations with 100 or more employees across the health care sector, including hospitals; ambulatory care providers; and nursing care, mental health and substance abuse facilities. What it will do: The rule mandates that organizations submit two detailed documents on work-related injuries and illnesses and individual incident reports on top of other reporting requirements.
| | | | JOIN 7/27 FOR A TALK ON WOMEN LEADERS IN THE NEW WORKPLACE: In the wake of the pandemic, U.S. lawmakers saw a unique opportunity to address the current childcare system, which has become increasingly unaffordable for millions of Americans, but the initial proposals went nowhere. With the launch of the Congressional Bipartisan Affordable Childcare Caucus in May, there may be a path to make childcare more affordable in the U.S. Join Women Rule on July 27 to hear from featured speakers Rep. Ro Khanna (D-Calif.), Rep. Nancy Mace (R-S.C.) and Reshma Saujani, Founder & CEO of Moms First and Founder of Girls Who Code, on ways to reach a bipartisan solution on this timely issue for women in the workplace. REGISTER HERE. | | | | | | | | MENTHOL BAN COULD BE A BUST — The FDA hasn’t approved a smoking-cessation tool in more than a decade, leading many experts to question its strategy to help Americans reduce the leading cause of preventable cancer, POLITICO’s Katherine Ellen Foley reports. Even as the agency prepares to roll out a menthol cigarette ban later this summer, the FDA’s bar for authorizing less-harmful menthol e-cigarettes to help smokers quit is so high that it could be impossible to reach. That’s the upshot of communications from the FDA to Logic, a major e-cigarette maker, and comments from former FDA officials and public health experts, who worry the impact of a menthol cigarette ban might fall far short of its desired effect. The communications appear in documents obtained by POLITICO through a Freedom of Information request. “If you set the bar that high, it’s a de-facto ban,” said a former senior FDA official granted anonymity to talk about the agency’s approach to tobacco regulation. The documents reveal the FDA denied authorization for Logic’s menthol e-cigarette in 2022 because of fears that minors could get hooked on the product, even as the agency acknowledged e-cigarettes might help adult smokers quit. After rejecting Logic’s menthol vapes, the agency has since denied authorization for similar vapes from other leading brands for the same reason. FDA response: The agency says the appeal to minors of nontobacco-flavored vapes, including menthol, informs the FDA’s work. It wants “robust behavioral evidence” that “would likely be product-specific evidence in the form of a randomized controlled trial or longitudinal cohort study” before it approves any flavored vapes, FDA spokesperson Courtney Rhodes said.
| | | STATE AGS PUSH ON SUBSTANCE-USE TREATMENT — Thirty-one state attorneys general — including six Republicans — are calling on Congressional leadership to bolster access to substance-use disorder treatment for incarcerated people. They’re pushing for lawmakers to pass the Due Process Continuity of Care Act and the Reentry Act that would expand Medicaid access to incarcerated people. “The added cost of substance use disorder treatment is burdensome for local jails and prisons to cover without additional funding support for medication, staffing, training requirements, and other treatment considerations,” the attorneys general wrote. “Oftentimes, this leads to no MOUD [Medication for Opioid Use Disorder] treatment being provided for this population and devastating health consequences.” House Energy and Commerce Committee ranking member Frank Pallone lamented that a subcommittee markup last week on reauthorizing the SUPPORT Act didn’t include the Reentry Act, which makes people eligible for Medicaid coverage 30 days before their release. The bill advanced to the full committee last week. People leaving incarceration are overwhelmingly more likely than the general population to overdose shortly after being released, studies have shown.
| | | | A message from PhRMA:   | | | | | GLOBAL KIDS’ VACCINATION RECOVERING UNEVENLY — More children were vaccinated globally against infectious diseases in 2022 compared with the previous year, but overall vaccination numbers are still below pre-pandemic levels, the World Health Organization and UNICEF said Monday, Carmen reports. Last year, 20.5 million kids worldwide missed out on one or more routine vaccines, nearly four million less than in 2021. But the number is higher than the 18.4 million kids who missed out on one or more shots in 2019, before the Covid-19 pandemic, underscoring the need for recovery and catch-up, the two U.N. organizations said. Improvements have been concentrated in a few countries, including India and Indonesia, while most low-income countries have seen slower recovery or even continued decline, particularly when it comes to measles. Calls for Gavi to do more: Gavi, the vaccine alliance that negotiates vaccine purchases for the world’s poorest countries, should temporarily waive co-financing requirements for countries and areas with fragile health systems or in humanitarian crises to help children catch up, global medical nonprofit Doctors Without Borders said.
| | Andrea Goldstein is now principal deputy assistant secretary for administration at HHS. She most recently was acting director of force resiliency at the Department of the Navy. Kevin Smith is joining the corporate communications team at Humana. He was formerly chief of staff for Sen. Rob Portman (R-Ohio). Matt Cook has been named the new CEO of the Children’s Hospital Association. Cook, president of UCSF Benioff Children’s Hospitals and senior vice president of Children’s Services at UCSF Health, begins the new role on Oct. 16.
| | STAT reports on Google and Epic’s opposition to tighter artificial intelligence regulation in health care. Healthcare Dive reports on electronic health records firm NextGen’s $31 million False Claim Act settlement. Researchers from the University of Michigan issued a report on policy takeaways from telehealth usage in Michigan.
| | | | A message from PhRMA: A new report showcases the vital role of post-approval R&D in nine critical oncology treatments. This research can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. See how post-approval R&D in cancer is at risk. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
