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With Megan Messerly
DEA WEIGHS VIRTUAL PRESCRIBING — Opioid treatment advocates are closely watching the DEA as its telehealth rulemaking process forges ahead, and some are raising concerns.
Under pandemic rules, providers could prescribe controlled substances, including treatments for opioid use disorder like buprenorphine, without an in-person visit. But with the end of the public health emergency in May, the DEA has been developing a post-pandemic policy.
In February, the agency proposed limiting telemedicine prescribing of buprenorphine to a 30-day initial supply. But after backlash from treatment advocates, the agency extended pandemic rules through at least November.
The latest: This month, the DEA said it would hold two in-person listening sessions in September on whether it should create a special registration process to allow providers to prescribe controlled substances without an in-person visit. Congress called for the DEA to create such a process in a 2008 law, but the agency hasn’t done so.
A DEA official previously told POLITICO it didn’t do so in earlier regulations over concerns it could create additional burdens.
The X-factor: Before Congress eliminated the so-called X-waiver in December, providers wanting to prescribe buprenorphine had to undergo a time-consuming process.
Libby Jones, project director of the Overdose Prevention Initiative, fears that a special registration process could present similar barriers to the X-waiver by adding another hoop for providers to jump through, reducing potential prescribers.
Dr. Brian Hurley, president of the American Society of Addiction Medicine, said that special registration would be counterproductive.
Advocates for the broader telemedicine community have applauded DEA’s openness to special registration. But it’s still not clear exactly what special registration would look like.
Ankit Gupta, CEO of telemedicine firm Bicycle Health, said special registration “should lean towards expanded access … with necessary safeguards, without the mandate of an in-person examination.”
Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, called for the DEA not to further regulate certified opioid treatment programs’ telemedicine use beyond Substance Abuse and Mental Health Services Administration proposals.
What’s next: The DEA’s extension runs out in November for new patients, so it must act quickly to finalize a rule. Zoe Barnard, senior adviser at Manatt Health, says to expect legal challenges if the DEA restricts access to important drugs.
WELCOME TO WEDNESDAY PULSE. What do you make of Biden’s mental health parity proposal? Is it workable? I want to hear from you — reach out at [email protected]. And send me or Chelsea ([email protected]) your feedback, tips and scoops. Follow along @_BenLeonard and @ChelseaCirruzzo.
TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Lauren Gardner, who sorts through HHS’ motion to dismiss a lawsuit by the U.S. Chamber of Commerce challenging the agency’s new-found authority to negotiate drug prices through Medicare and the legal challenges facing the Biden administration’s efforts to lower drug costs.
HOLIDAY SPENDING FIGHT IN ORDER? With fewer than 50 days remaining until government funding runs out, Senate Majority Leader Chuck Schumer is signaling openness to a short-term spending stopgap through early December, POLITICO’s Caitlin Emma reports.
Schumer said he spoke with House Speaker Kevin McCarthy ahead of the August recess about the need for a temporary measure — a continuing resolution. McCarthy acknowledged that the House will need to do so in a Monday night conference call and vowed such a measure would go no later than early December.
“I thought it was a good thing that he recognized that we need a CR,” Schumer said Tuesday. “I’m supportive of that.”
Not a shocker: Senate and House lawmakers will have major differences to bridge in spending talks. Congress has passed a continuing resolution through December in each of the last three years.
‘GO FASTER’ — As states like Arkansas and Idaho move quickly through the Medicaid unwinding process, health officials elsewhere have been forced to answer questions from their Republican legislatures about why they can’t rush through the process, too.
North Carolina: Kody Kinsley, the state’s Health and Human Services secretary, told Megan that lawmakers were pitched “magic tools” by third-party vendors promising to help the state speed through the unwinding process.
But Kinsley said at the National Academy for State Health Policy’s conference in Boston the department felt strongly about taking the full year recommended by CMS.
“They were hearing from a lot of folks about how wonderful and glorious this was going to be,” Kinsley said. “We pushed back hard.”
Utah: The state developed its 12-month unwinding plan over the course of more than a year, but lawmakers urged state health officials to pivot after they heard their neighbors to the north were completing that work in essentially half the time, said Nate Checketts, Utah’s Medicaid director.
“We had sent notices to members. We had told them when their renewal date was, and then Idaho goes and does theirs in six months, and guess what our legislators saw on the news?” Checketts said. “We’ve had some very significant pressure over the last two or three months.”
Checketts said the agency told lawmakers that eligibility staff were already doing 200 to 250 percent of the reviews they used to do to complete their work in 12 months and that cutting that timeframe in half would create significant issues.
Instead, state health officials moved a group of Medicaid recipients whose complete renewal information was missing to the top of their renewal list. It’s an approach several states are taking, arguing that those people are likely no longer eligible.
HHS AI APPLICATIONS EXPLODE — HHS is joining in on the artificial intelligence hype.
The agency’s reported planned or current uses of AI have risen to 163 across its subagencies as of fiscal 2023, up from 50 in the previous year. The FDA, CMS, the CDC and the NIH are among the subagencies with the most reported applications of AI, which come in a broad spectrum.
For example, CMS plans to use AI to predict drug price changes and cost anomalies and develop a fraud-detecting model. The CDC is crafting machine learning models to flag walking and biking trips in GPS data to help track mobility like was done during the pandemic.
FedScoop first reported the disclosure, which was required under a late 2020 Trump administration executive order.
NEW SUBSTANCE-USE DATA — Nearly a third of U.S. adults said they or someone in their family has been addicted to opioids, according to a new KFF poll.
Nearly half of rural Americans (42 percent) said the same compared with 30 percent of those surveyed in suburban areas and 23 percent in urban areas. There were racial disparities: 33 percent of white respondents said they or a family member had been addicted to opioids compared with 28 percent of Hispanic respondents and 23 percent of Black respondents.
The policy angle: Support was overwhelming across party lines for facilitating addiction treatment centers “in their community” (90 percent) and making overdose reversal drug Narcan available in public places (82 percent).
But safe-consumption sites that allow people to use drugs with trained supervisors continue to be controversial. Forty-five percent of respondents supported them, including just a quarter of Republicans. On the other side, 61 percent of Democrats supported them, along with half of independents.
LEIDOS: REFORM SECURITY CLEARANCES — Leidos, the heavyweight government contractor working with every federal health agency, is calling for reforms tied to mental health in the security clearance process in the intelligence community.
In a brief released Monday, the firm said that while seeking mental health treatment isn’t a reason by itself to deny clearances, its survey results of 300 prospective hires found that about half think mental health issues hurt clearance adjudication despite a large majority being willing to disclose mental health information. It pointed to federal data showing that just 62 of 5.4 million cases were denied for mental health reasons.
“I hadn’t realized how little progress had been made,” after changes to the process two decades ago, Roy Stevens, the firm’s intelligence group’s president, told Pulse. “Government is always a little slower to change than the rest of society.”
Leidos called for:
— Continuous monitoring of mental health to ensure faster treatment
— Leadership to discuss mental health issues openly
— Recruiter training to learn how to destigmatize mental health
Tom Robertson will join Manatt, Phelps & Phillips as a consultant. He’s currently a national adviser at Manatt Health.
Dr. Robert Steinbrook has been named the new director of health research at Public Citizen. He was previously editor-at-large at JAMA Internal Medicine.
The San Francisco Chronicle details alleged “absolute neglect” at a luxury pet hotel chain.
Healthcare Dive reports on Amazon Pharmacy’s expansion of insulin coupons.
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