| | | | |  | | By Ben Leonard and Chelsea Cirruzzo | Programming note: We’ll be off Wednesday for Juneteenth but will be back in your inboxes on Thursday. With Carmen Paun and Ruth Reader
| | |  Both the founder and the clinical president of Done, a digital health company, have been charged with overprescribing Adderall to patients who didn't need the drug. | Jenny Kane/AP | DONE, DONE, DONE — A federal indictment of top executives at digital health company Done over charges related to overprescribing stimulants for ADHD comes as the DEA closes in on proposing rules that could shake up the telehealth industry. The Justice Department late last week charged the California-based company’s founder, Ruthia He, and its clinical president, David Brody, in an alleged $100 million distribution and health care fraud scheme. Prosecutors allege the two conspired to purposely structure the platform to offer “easy access” to stimulants, including by mandating initial visits be less than 30 minutes and prescribing Adderall even if the member didn’t qualify. The CDC warned that a disruption at the company could impact as many as 50,000 patients. Brody and He didn’t respond to requests for comment, and Done hasn’t issued any public statements after the charges. The charges come as the DEA weighs the future of controlled substance prescribing. The DEA has allowed controlled substances like Adderall and testosterone to be prescribed without an in-person visit under extended pandemic rules that expire at the end of the year. The agency sent its proposed rules to the White House for review last week, signaling the proposal could come soon. The industry responds: Top telemedicine groups said that Done’s alleged behavior doesn’t reflect the vast majority of virtual care providers and the system of accountability is working. “The share of bad actors is pretty low,” said Chris Adamec, executive director of telehealth lobbying group Alliance for Connected Care. “We have seen a few companies who really stretch the limits, but they’re the outlier — just like in any other industry. This is not unique, and the enforcement tools are already there.” “We shouldn’t be putting in place tremendous new hindrances … just because of the misdeeds of a very select few,” Kyle Zebley, the executive director of the American Telemedicine Association's lobbying arm, ATA Action, told Pulse. What’s next: The DEA has said it aims to finalize the prescribing rules by the fall. In early 2023, the DEA proposed curtailing the pandemic-era regulations but received backlash and reversed course. Mental health groups are calling for the DEA to allow providers to prescribe stimulants for ADHD without an in-person visit. WELCOME TO TUESDAY PULSE. Do you work at Done, or did you previously? We want to hear from you and can keep you anonymous. Reach us and send us your tips, news and scoops at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo.
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Surgeon General Vivek Murthy is asking Congress to pass legislation that would require warning labels on social media. | Jose Luis Magana/AP | SOCIAL MEDIA LABELS — Surgeon General Vivek Murthy is pushing for tobacco-style warning labels on social media — but with no power to issue those warnings unilaterally, Murthy can only plead with Congress to act, a move the Biden Administration has been attempting one way or another for three years, Ruth and POLITICO’s Rebecca Kern report. As anxiety about kids’ social media use has grown, President Joe Biden has tried to use the issue as a way to jumpstart longstanding efforts to enact regulation on technology. The result has been a litany of calls to action, unfilled proposals and bills that have stalled. Biden mentioned kids and technology in all three of his State of the Union addresses and launched a kids’ online health and safety task force in May to come up with policy guidance and other recommendations. Murthy himself has weighed in on children’s online safety before, publishing a health advisory outlining potential harms. Several attempts by Congress to draft legislation have foundered against the unwavering objections of the tech industry — as well as policy disagreements, including whether a federal law should preempt the state laws that have advanced. Why it matters: Murthy’s advisory inspired the bipartisan Kids Off Social Media Act, but it has failed to move so far. What’s next: Parents and children’s groups are pressuring legislators to pass the Kids Online Safety Act, a bill that requires social media companies to mitigate foreseen dangers to children but doesn’t call for a surgeon general’s warning label. Murthy told POLITICO that while he wants companies to disclose harms, having a surgeon general’s warning on social media platforms offers a particular advantage. “Many people know about the surgeon general’s warning — they’ve seen them on alcohol bottles or on tobacco products,” he said. “Our office has a long history of being trusted on issues related to public health.”
| | STRUGGLES TO COMBAT CRISIS CONTINUE — A pair of new studies tied to federal agencies underscore the ongoing challenges that remain in addressing the opioid epidemic. The first, a large NIH-funded study published in The New England Journal of Medicine, found that an intervention in some communities in four states ravaged by the crisis between July 2021 and June 2022 didn’t result in statistically significant differences in overdose deaths when compared with areas not receiving the intervention. It focused on education, safer prescribing and bolstering access to overdose reversal drug naloxone and treatment for opioid use disorder. The researchers said the growth of fentanyl in the drug supply, the pandemic and insufficient time to implement the interventions may have contributed to the results. The second, a study sponsored by the NIH, SAMHSA, the CDC and CMS published in JAMA Internal Medicine, found that among Medicare beneficiaries who had a nonfatal overdose in 2020, just 4 percent received medication treatment and 6 percent filled a naloxone prescription in the year after the overdose. The big picture: Solutions to the opioid epidemic have been vexing for policymakers as more than 100,000 Americans die every year from drug overdoses.
| | COVID-ORIGIN DEBATE HITS THE SENATE — The question of whether the Covid-19 pandemic originated from an animal or through a lab leak moves to the Senate today via a hearing to examine the available evidence, Carmen reports. But only one of the four witnesses before the Homeland Security and Governmental Affairs Committee — Robert Garry, a virologist and associate dean at Tulane University’s School of Medicine — is expected to argue that the pandemic had a natural origin. The other three witnesses — Gregory Koblentz, director of the biodefense graduate program at George Mason University; Dr. Steven Quay, CEO at Atossa Therapeutics; and Richard Ebright, a molecular biologist and lab director at Rutgers University — either support the lab leak theory or have called for stronger lab standards in the wake of the pandemic. The House Select Subcommittee on the Coronavirus Pandemic has so far investigated Covid origins, with the Republican majority leaning heavily toward the lab leak theory. Why it matters: The debate about a potential lab origin for the pandemic led to calls for a reform of the NIH, which founded coronavirus research at the lab in China at the heart of the theory. Those proposals, by Sen. Bill Cassidy (R-La.), ranking member of the Health, Education, Labor and Pensions Committee, and Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, don’t go far enough in restricting funding of risky research, said Sen. Roger Marshall (R-Kan.), a member of the Homeland Security Committee, in a briefing with reporters Monday.
| | | | SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRIBE NOW. | | | | | | | | | END OF CHANGE PROGRAM — The Centers for Medicare and Medicaid Services is ending its accelerated and advanced payment program for providers impacted by the massive Change Healthcare attack on July 12, the agency said Monday. At that time, the agency will stop new applications for the program, which so far has offered more than $3 billion in payments to thousands of providers and suppliers.
| | | | ENHANCED PREMIUM TAX CREDIT IMPACT — Enhanced premium tax credits for Affordable Care Act marketplace plans will cut the number of uninsured people in the U.S. by 4 million next year, the final year before the credits expire, according to new Urban Institute research funded by the Robert Wood Johnson Foundation. Congress and the Biden administration extended the credits in the Inflation Reduction Act. The Congressional Budget Office has made similar projections to the think tank’s research, released Monday, though over a longer time. The findings come amid a push from conservatives to let the enhanced tax credits expire, arguing the ACA didn’t intend to fully subsidize plans for enrollees. The issue is sure to be a major point of contention in the next Congress.
| | Reuters reports that kids' weight-loss options are “hard to come by.” Healthcare Dive reports on the Biden administration giving providers hit by the Change Healthcare attack more time to ask for surprise-billing arbitration. | | | | Follow us on Twitter | | | | Follow us | | | | |
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