| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | | | | | 
Several proposed health care regulations the Biden administration hoped to pass are lingering at the OMB, including a bipartisan gun-safety deal that was made after a mass school shooting in Ulvalde, Texas, in 2022. | Eric Gay/AP | RULES IN WAITING — Earlier this year, the Biden administration finalized a slew of health care rules to avoid a key deadline and prevent Congress from overturning them under a new administration. And with just a few months left in President Joe Biden’s term, a number of other regulations are in limbo at the Office of Management and Budget, Ben reports. The White House has finished many health care regulations, including those to safeguard abortion data, expand antidiscrimination laws and set minimum staffing levels at nursing homes. But controversial rules expanding requirements that insurers treat mental health care similarly to other kinds of health care and governing the virtual prescription of some controlled substances have yet to be completed. Still others have languished awaiting review at OMB. That signals that they might not get done before Biden heads for the exits. OMB declined to comment on its review pace, which has been close to a year and in some cases close to two years. Notably, a proposed ban on menthol cigarettes has been at OMB since October and is unlikely to be finalized before the November election amid White House concerns that it could hurt standing with Black voters. In its most recent rulemaking agenda, the administration put the ban on a list of long-term items it doesn’t plan to address within the next year. Here are other significant proposed and final rules that haven’t cleared review: — Pandemic preparedness: An HHS proposed rule would update emergency preparedness mandates for providers and suppliers participating in Medicare and Medicaid reached OMB last October and is still pending review. The latest unified agenda targets the release of the proposed rule in July, which came and passed. — Covid and the workplace: Controversial final Occupational Safety and Health Administration rules aimed at protecting health care workers from Covid-19 have been at OMB for review since December 2022. The latest unified agenda says they’re planned for release in December. Hospitals have opposed the rules, but unions representing health care workers support them. The latest unified agenda targets the release of the proposed rule for December, but it’s unclear whether they’ll be finalized, given that Covid’s threat has lessened. — Firearm checks: The administration is still implementing a bipartisan gun-safety deal aimed at enhancing mental health programs, strengthening background checks and providing law enforcement and gun control grants, blowing past legal deadlines. The deal came in response to the 2022 mass shooting in Uvalde, Texas. Two proposed rules related to background checks have been at OMB since May and September of 2023. The latest agenda targeted July and August for their release, respectively. WELCOME TO TUESDAY PULSE. I went to get a facial recently and was asked to sign a HIPAA disclosure form — it turns out the spa I was at also offers Botox and other medical procedures. It had me wondering how many other unexpected places might be collecting health data. Thoughts? Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
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If passed, the BIOSECURE Act would stop federal contracts with foreign adversaries' biotech companies. | Greg Baker/AFP via Getty Images | BIOSECURE VOTE NEXT MONTH — House leaders hope to bring a vote on various China-related bills, including the BIOSECURE Act, to the floor in late September, per four House aides close to discussions, POLITICO’s Ari Hawkins reports. A schedule hasn’t yet been finalized, but votes are expected to coincide with a so-called China Week next month. The bills are expected to be brought for a vote individually instead of as part of a larger bundle. Those bills include the BIOSECURE Act, which would halt federal contracts with biotech companies in adversarial regions, the House aides confirmed. Biotech companies have been in an awkward position regarding the bill: If they favor it, they might anger Beijing, which has a penchant for corporate retaliation, while companies eyeing carve-outs could look lax on national security. Speaking in favor of the legislation “can put people in danger,” said a lobbyist specializing in trade and international issues granted anonymity to discuss private concerns.
| | A DEADLY MIX OF DRUGS — Fatal overdoses involving fentanyl are increasingly occurring alongside the use of stimulants, which are also being used more frequently. According to a Pew Charitable Trusts fact sheet out Monday, more than 10.2 million people ages 12 and older misused stimulants, which includes cocaine, prescription stimulants for ADHD and methamphetamine, in 2022. That’s a nearly 9 percent increase from 2021.
|  | | Why it matters: While the U.S. is making small progress toward decreasing fentanyl-involved deaths, stimulant use is on the rise. For the first time since 2018, the CDC in May reported a decrease in drug overdose deaths in 2023, including a decline in fentanyl-related estimated deaths. However, the CDC also reported an increase in estimated stimulant-related deaths. “[C]ombined, opioids and stimulants taken together increase overdose risk, especially for people who use stimulants but don’t regularly use opioids,” Pew researchers write. According to their analysis, less than 1 percent of fatal overdoses involved stimulants in 2010 compared with 32 percent in 2021. The problem: While HHS acknowledged in a November report that stimulant use is on the rise, the agency also said barriers exist to implementing effective treatments, including limited funding and reimbursement, program restrictions on substance-use disorder programs and stigma. In 2022, an estimated 4.5 million people had a stimulant use disorder, but only 888,000 received treatment, per a CDC survey.
| | | | COVID SUMMER SURGE — The percentage of people testing positive for Covid-19 nationwide has risen over the past two weeks as most of the country experiences a summer surge. According to CDC data posted Monday, test positivity for the week ending Aug. 3 is 17.6 percent, up from 15.6 percent in the previous week. Why it matters: The CDC, which considers Covid-19 endemic or here to stay, said last month that the virus is not a typical “winter” respiratory virus, as it can surge during other seasons as it mutates. Background: Covid has surged in waves during hot and cold seasons: Summer 2021 saw a surge due to the Delta variant as did winter 2021 due to the onset of Omicron while the emergence of an Omicron subvariant led to a surge in summer 2022. Two additional surges occurred between June and December 2023 as another Omicron subvariant emerged, per CDC data. CDC data on Covid wastewater has signaled that the U.S. has been experiencing an increasing surge for weeks. The most recent data, updated Friday, shows most states reporting “high” or “very high” viral activity in their wastewater — usually an early sign of sickness in the population. And some states, including Florida, Michigan, Mississippi, New Jersey and Texas, have had some of the highest Covid-19 death rates — at more than 2 percent — in the past week. In Mississippi, where the death rate in the past week is 3.7 percent, state epidemiologist Dr. Kathryn Taylor told Pulse in a statement that their Covid rates are “similar to the overall trend in the US currently.” “In the last few weeks, the number of COVID-19 deaths have also increased. This is something we have seen throughout the pandemic. When the numbers of COVID-19 cases rise, we tend to see an increase in COVID-19 related deaths which lags behind the increase in cases,” she said. And in Michigan, where the death rate in the past week is 2.6 percent, a health department spokesperson said Covid disease indicators are rising, including wastewater surveillance and ER visits, “but are increasing from a low level – similar to the pattern seen in 2023.”
| | | | The American Hospital Association has named the members of its board of trustees starting in 2025: Michael Ugwueke, president and CEO of Methodist Le Bonheur Healthcare; Joan Coffman, president and CEO of St. Tammany Health System; Leslie Hirsch, president and CEO of Saint Peter’s Healthcare System; Dr. Philip Ozuah, president and CEO of Montefiore Medicine; Brian Peters, CEO of the Michigan Health & Hospital Association; Lisa Shannon, president and CEO of Allina Health; Dr. Robert Vissers, president and CEO of Boulder Community Health; Bill Gassen, president and CEO of Sanford Health; and Joseph Impicciche, chief executive officer of Ascension Healthcare.
| | Reuters reports on the FDA’s approval of a treatment for hypoparathyroidism, a hormone disorder treatment. The Associated Press spoke with Pfizer’s CEO about its move from Covid-19 vaccines to investments in weight loss and cancer drugs.
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