Psychedelic drug therapy: Just say yes

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Aug 14, 2023 View in browser   By Chelsea Cirruzzo and Ben Leonard Driving the Day Rep. Jack Bergman authored a provision to the VA appropriations bill that would require the agency to research the efficacy of psychedelic drug therapy for PTSD. | House Television via AP Photo CONGRESS WARMS TO PSYCHEDELIC DRUGS — Psychedelic medicine is forging unexpected alliances in Washington. In the House, Democrats, including Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Lou Correa (D-Calif.), and Republicans led by Reps. Dan Crenshaw (R-Texas) and Jack Bergman (R-Mich.) have emerged as early champions of the issue. The House’s appropriations bill for the Department of Veterans Affairs includes an amendment that would require the VA to conduct a clinical study on psychedelics. Its version of the annual defense policy bill calls for similar research on troops, POLITICO’s Katherine Ellen Foley and Erin Schumaker report. Rep. Morgan Luttrell (R-Texas), a former Navy SEAL, has gone as far as to publicly say that psychedelic treatment he received in Mexico saved his marriage. Meanwhile, the wheels are turning at the Food and Drug Administration, which has approved a version of ketamine for treatment-resistant depression and granted two other psychedelics — psilocybin and MDMA — breakthrough therapy status, meant to speed their development. All eyes are on the Multidisciplinary Association for Psychedelic Studies, which plans to file for regulatory approval of MDMA, also known as ecstasy, by the end of the year. Should the process go smoothly, MDMA could be on track for approval as a PTSD treatment by 2024. Why it matters: More than 27 percent of the U.S. reported experiencing symptoms of anxiety and depression between the end of June and the start of July, according to the CDC, and the VA estimates that 5 percent — or 13 million Americans — are currently living with post-traumatic stress disorder. “These breakthrough therapies represent hope for tens of thousands of Veterans every day suffering from the invisible wounds of war," Bergman, the author of the appropriations provision, said in a statement. Even so: While early results from psychedelic studies are promising, the hype could easily get ahead of the research, as it did after the 1960s, and fuel backlash, advocates, researchers and lawmakers told POLITICO. Those dangers are all the more reason for Washington to move assiduously, said Luttrell. “My biggest concern is that it comes off the rails, and people take advantage of it — and we lose it," he said, adding that, with rigorous oversight, “we can show the American public that we’re not just throwing Jell-O at the wall.” WELCOME TO MONDAY PULSE. HHS has declared a public health emergency in Hawaii in response to wildfires in Maui. Here are some ways you can help those impacted by the fires. Send your tips, scoops and feedback to bleonard@politico.com and ccirruzzo@politico.com and follow along @_BenLeonard and @ChelseaCirruzzo. TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with Katherine Ellen Foley, who explains what's behind the growing bipartisan support for bolstering research on using psychedelic drug therapy to treat mental health issues like PTSD, anxiety and depression. Listen to today’s Pulse Check podcast In Congress Rep. Suzan DelBene leads a bipartisan group of lawmakers urging CMS to make changes to its proposed prior authorization rule. | Francis Chung/POLITICO CMS RESPONDS TO PRIOR AUTH PUSH — CMS told a large group of lawmakers pushing for changes to its prior authorization proposal that it aims to finalize the rule “as soon as possible” and “appreciates” their feedback, according to a letter obtained by POLITICO, Ben reports. CMS’ response to the more than 230 House members and 61 senators has few, if any, other new details. The bipartisan group led by Rep. Suzan DelBene (D-Wash.) called on CMS to tweak a rule it proposed in December that would mandate insurers modernize how they process requests from providers to authorize treatments. They called on the agency to include provisions from DelBene’s Improving Seniors' Timely Access to Care Act, which aims to speed up the prior authorization process for Medicare Advantage plans. CMS has set a December 2025 date for finalizing its rule but says it will publish it sooner if it can.   YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today.     Providers HOSPICES WANT AUDIT REFORM — Hospice providers are calling on CMS to reform its auditing practices ahead of the agency’s efforts to more closely inspect hospices. Background: In July, CMS said it would provide additional oversight for newly enrolled hospices in Arizona, California, Nevada and Texas, citing increased reports of waste, fraud and abuse. The agency also proposed in its CY 2024 home health prospective payment rule to increase the screening of hospice managers. In a letter sent to CMS on Friday, providers — including LeadingAge and the National Hospice and Palliative Care Organization — asked the agency to shift its auditing practice from collecting large initial overpayments to instead focusing on halting bad practices in hospices. The asks: They also want a less lengthy audit recovery and appeals process and more transparency about CMS contractors, including how many and what types of audits are being conducted, audit recovery amounts, results, reversal rates and reasons for denials. ‘SIMPLY UNACCEPTABLE’ — The American Hospital Association expressed dismay at the nearly $1 billion cut in payments to safety-net facilities in a recent letter to CMS Administrator Chiquita Brooks-LaSure, POLITICO's Daniel Payne reports. Safety-net hospitals care for more uninsured or government-insured patients than compared to other facilities. The AHA pleaded for more time before the administration decides on payments, arguing that Medicaid redetermination will significantly alter the financial footing of hospitals that largely rely on the program. The letter is part of a larger pushback from the hospital industry on the payment rule. The AHA and others have pointed to high labor costs and inflation more generally when arguing for more pay from the government. But the administration has defended its rule, saying it’s “consistent with the Administration’s goal of advancing health equity for all.” IN THE STATES ABORTION BAN CHALLENGE DISMISSED — A Nebraska judge upheld on Friday a bill that bans abortion after 12 weeks and bans gender-affirming care for minors. What happened: The bans, expected to take effect in October, were challenged by the ACLU and Planned Parenthood of the Heartland. They argued that the law was unconstitutional because lawmakers added the abortion ban as an amendment to an existing bill on gender-affirming care, which goes against the state’s one-subject requirement for bills. Judge Lori Maret, however, ruled in favor of Nebraska’s attorney general to dismiss the case, writing that the one-subject rule can be construed broadly. The ACLU and Planned Parenthood say they plan to appeal. Beyond Nebraska: Across the nation, states are taking up bans on gender-affirming care, which providers say makes it harder everywhere to care for transgender youth, POLITICO’s Megan Messerly previously reported. Eye on Insurers INFORMATION GAPS — Health insurers might not be providing patients with adequate information on their eligibility for full coverage of preventive services like cancer and depression screenings, suggests a new report from consumer representatives of the National Association of Insurance Commissioners, POLITICO’s Kelly Hooper writes. Background: For more than a decade, the Affordable Care Act has required most health plans to fully cover preventive services, which can include screening tests or interventions designed to prevent diseases The findings: The report from NAIC, the national trade group for state insurance regulators, found inconsistent implementation of the ACA requirement, which could jeopardize consumers’ access to the free services. For example: — Health plans had varying information describing preventive coverage, including gaps and inconsistencies on consumer-facing brochures and fact sheets. — Drug lists did not consistently list preventive medications as covered without cost-sharing. — Guidance on how providers code services as preventive was inconsistently available or rarely provided complete information. Insurer reaction: AHIP, the lobbying organization for health insurers, told POLITICO that it’s “reviewing the report, and we look forward to engaging in more detail.” “For years, health insurance providers have covered preventive services as recommended by USPSTF, ACIP, and other agencies,” AHIP spokesperson David Allen said in a statement. What We're Reading POLITICO Pro’s Madina Touré reports on a ruling to block NYC’s mayor from forcing city workers onto Medicare Advantage. KFF Health News reports on the scramble of providers to define policies on providing Alzheimer’s drug Leqembi to patients. STAT reports on investigations by bird flu researchers into the virus in Finland’s minks.   DON’T MISS POLITICO’S TECH & AI SUMMIT: America’s ability to lead and champion emerging innovations in technology like generative AI will shape our industries, manufacturing base and future economy. Do we have the right policies in place to secure that future? How will the U.S. retain its status as the global tech leader? Join POLITICO on Sept. 27 for our Tech & AI Summit to hear what the public and private sectors need to do to sharpen our competitive edge amidst rising global competitors and rapidly evolving disruptive technologies. REGISTER HERE.       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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