An uncertain future for virtual opioid use treatment

By Ben Leonard and Ruth Reader

Presented by Bamboo Health

Federal regulations allowing online prescribing for drugs to treat people addicted to opioids could soon lapse, leaving an uncertain path forward for thousands of patients turning to virtual treatment and the digital health companies themselves.

Startups providing buprenorphine to treat opioid use disorder took off amid the pandemic when the federal government began letting patients skip normally required in-person visits. Many patients have found it faster, easier and more private than going to a doctor’s office to be treated for the stigmatized disease.

The eased rules could expire along with the Covid-19 public health emergency, which the Department of Health and Human Services could end as soon as October. That’s left public health officials fearing they might lose a key tool to fight the opioid crisis, which has deepened amid the pandemic.

Recent studies show prescribing buprenorphine via telemedicine is at least as effective, and sometimes more effective than in-person treatment, in keeping patients on the medication.

“If we now remove the flexibilities with telehealth, we will make the problem even worse,” Nora Volkow, director of the NIH’s National Institute on Drug Abuse, told POLITICO. “Patients will just go untreated.”

Adding to the uncertainty is the Drug Enforcement Agency, which has blown through deadlines to expand virtual care access, including a pledge in 2009 to do so. The DEA told key lawmakers in May it’s working to make the pandemic-era regulations permanent. Some believe the DEA, which declined comment, has sought to crack down on misuse of buprenorphine over concerns that the drug could be sold illegally.

“There’s no reason right now for the DEA to be approaching buprenorphine the way that they do,” said Bayla Ostrach, a professor at Boston University School of Medicine. “People are going to die while they delay.”

Several digital health companies behind the telemedicine treatment boom have contingency plans if the regulations expire along with the emergency. But they said it would hurt their ability to expand and would harm patients.

“Meeting that in-person regulation requires us to have bodies everywhere. And that’s just unrealistic,” said Jonathan Ciampi, CEO of Bright Heart Health, which provides virtual treatment in most states. “There’s not enough mental health [and] substance use providers in the country to treat everybody.”

Even outside of federal regulations, state laws also restrict access to buprenorphine, experts said, which has stifled companies looking to reach more states.

Although plenty of experts are optimistic about buprenorphine via telemedicine, some fear the quick expansion of access poses risks, and more research is needed on virtual treatment.

“The fact that telehealth is useful does not mean it’s going to be useful no matter how it is deployed and what you offer to the patient,” Volkow said, pointing to digital mental health company Cerebral, which is in hot water over allegedly overprescribing controlled ADHD medication.

That has left some executives, including Ciampi, concerned it could affect the perception of online buprenorphine prescribing. Others aren’t as worried, including Zack Gray, CEO of virtual treatment company Ophelia.

“It's just very clear that [Cerebral] took a very different approach … than we have, so I'm fully prepared to talk to the regulators if they want to talk to us. I'm not worried about it,” Gray said. “But from the public standpoint, it's not going to be pleasant to have those conversations.”

Welcome back to Future Pulse, where we explore the convergence of health care and technology. This week health and tech are intersecting with animal husbandry: Cows in Wisconsin are getting an update — literally. A company called Smaxtec is connecting cows to the cloud with health-monitoring devices that track disease, milk production, fertility and pregnancy. Talk about the panopti-cow.

Share your cow puns, news, tips and feedback with Ben at bleonard@politico.com or Ruth at rreader@politico.com and follow us on Twitter for the latest @_BenLeonard_ and @RuthReader. Send tips securely through SecureDrop, Signal, Telegram, or Whatsapp here. 

A message from Bamboo Health:

According to the National Alliance on Mental Illness, 1 in 5 U.S. adults recently experienced a mental illness. But now, people in need have a lifeline. On July 16th, 988 goes live and across the country, states are required to implement crisis lines and support systems. Bamboo Health is here to help you create the coordinated crisis infrastructure you need to support 988. Visit BambooHealth.com/988ready to learn more about our 988 resources.

“Genevieve Morris @HITpolicywonk: “Sigh, when will we accept that interop is less of a tech problem and more of a trust/policy/business problem? (Aside from the obvious tech issues of patient match and consent which we just keep punting on, and I don't think Oracle solves).”

TELEHEALTH IN GUN PACKAGE — A bipartisan group of senators released bill text for gun-safety legislation Tuesday night with provisions aimed to bolster telehealth access.

The text — unveiled by Sens. Chris Murphy (D-Conn.), John Cornyn (R-Texas), Kyrsten Sinema (D-Ariz.) and Thom Tillis (R-N.C.) — includes $80 million in grant funding for primary care doctors to access mental health providers for pediatric patients.

The legislation also requires HHS to provide guidance to states on how to expand telehealth access via Medicaid and the Children’s Health Insurance Program (CHIP).

The next steps: The legislation, which comes in the wake of the elementary school shooting in Uvalde, Texas, could see a vote for final passage by the end of the week.

The discussion draft of the legislation garnered the support of 20 senators, including 10 Republicans — enough to clear the Senate filibuster. Senate Minority Leader Mitch McConnell also declared his support for the text Tuesday night.

PUBLIC HEALTH DATA OVERHAUL — A number of former top health officials — including ex-FDA commissioner Margaret Hamburg and former ONC heads David Blumenthal and Karen DeSalvo — called on the U.S. to revamp its public health system, including calling for Congress to establish minimum data standards for states.

The Commonwealth Fund Commission , chaired by Hamburg, also wants Congress to create an HHS undersecretary position for public health to lead the public health system.

“The CDC plays a very important role, but it doesn’t have the prominence in the federal bureaucracy that is needed to coordinate across agencies,” Blumenthal, the Commonwealth Fund’s president, told Future Pulse. “We have no commander-in-chief for defense against biological assault.”

The report called for lawmakers to boost funding for state and local infrastructure for jurisdictions meeting standards. The Biden administration should also update standards for local health departments “focus[ing] on basic capabilities for public health protection,” the sweeping report said.

“We may need to rebalance authority somewhat so that we recognize that when one state fails to protect its population, every other state suffers,” Blumenthal said. “Federalism needs to be a balanced situation, and we’re out of balance in the public health realm.”

Covid-19 laid bare a patchwork system of outdated state health data systems that hampered the pandemic response.

A message from Bamboo Health:

Data from appointment booking platform Zocdoc shows telehealth usage has dropped precipitously since the height of the pandemic. Zocdoc’s data finds the vast majority of health care is happening in person. The one exception to that rule is mental health.

EPIC JOINS TEFCA — Electronic health records giant Epic plans to join the Trusted Exchange Framework and Common Agreement from the Sequoia Project and the Office of the National Coordinator for Health IT. The Sequoia Project is the recognized coordinating entity for TEFCA.

Epic will apply to be a Qualified Health Information Network, or QHIN, when the process starts later in the year, the company said in a release. TEFCA aims to facilitate data sharing among networks in a way similar to that of cell carriers facilitating calls between customers with different providers.

Micky Tripathi's ONC and the Sequoia Project spearhead TEFCA. | Office of the National Coordinator for Health IT

Under the framework, QHINs would be able to share data across the country, provided they sign a common agreement and have the proper infrastructure to do so. As the EHR vendor with the largest market share, Epic’s decision to join TEFCA provides a boost for the endeavor.

“One of the biggest obstacles is that it takes a little bit of time for a new framework like this to gather the critical mass together to actually get the volume of exchange,” Matt Doyle, Epic’s research and development lead. “We’re hoping … [we can] drive that early adoption.”

CommonWell Health Alliance, Health Gorilla and eHealth Exchange have signaled they also would like to become QHINs.

INTRODUCING DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.

DAOS ARE IN — TEFCA will allow distributed autonomous organizations to join its network. An interesting question arose during Sequoia Project’s monthly public call outlining updates on TEFCA: Is there anything in the proposed rules that would prevent distributed autonomous organizations, which are headless organizations popular among blockchain and crypto enthusiasts typically used for fundraising, from becoming a qualified health information network?

“The fact that you are a distributed autonomous organization or any other organizational structure doesn’t necessarily prohibit you from becoming a QHIN,” said Alan Swenson, executive director of Carequality at the Sequoia Project.

In the past, DAOs have had difficulty ensuring their networks are secure. Still, as long as they can meet the requirements for becoming a QHIN, including cybersecurity prerequisites, Swenson says DAOs are a go.

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

Grace Oldham and Dhruv Mehrotra, Reveal: Facebook and anti-abortion clinics are collecting highly sensitive info on would-be patients

Christina Farr, Substack: Virtual care has its gaps — it’s time we talked about it 

Eric Perakslis, Contemporary Clinical Trials: Beyond privacy: A deeper understanding of the internet is required to protect digitized trial participants

A message from Bamboo Health:

The introduction of 988 is an opportunity to change the way the U.S. responds to individuals with a range of behavioral health issues. It will help to direct individuals to the appropriate level of care, instead of diverting them to hospital emergency departments, or even law enforcement.

With the rapidly approaching July 16th launch of 988, states must comply with federal law and develop a plan and infrastructure to support their communities' adoption of 988 services. Bamboo Health partners with state government leaders to provide that plan and crisis management infrastructure, along with expert guidance around securing federal funding, to ensure a smooth launch. We also offer ongoing support across your entire 988 ecosystem.

Visit BambooHealth.com/988ready to download our crisis management playbook, and learn more about our 988 resources.

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