August 30, 2024

Politico Pro – 8/30/24 @ 2:13 pm

A senior Senate Democrat joined mental health experts and opioid use disorder advocates in hammering a draft DEA proposal that would significantly limit the prescribing of controlled substances via telemedicine.

The proposal, which has not been released and could change, allows no more than half a provider’s prescriptions to be given virtually. If finalized, it would be a substantial blow to many telemedicine providers who rely mostly or exclusively on virtual care.

This is the second time the DEA has floated tightening pandemic-era rules that made it easier to prescribe virtually. The agency backed off its first proposal following a flood of protests and this latest draft,first reported by POLITICO, is sparking similar outrage.

“As currently reported, the DEA’s proposal provides an even worse solution than the one put forth under the first proposed rule. This arcane approach would represent a significant step back for patients who rely on telemedicine for critical medications,” Sen. Mark Warner (D-Va.) said in a statement. “The pandemic proved that the vast majority of health care providers can successfully provide quality health care through telehealth. We don’t need an arbitrary new set of regulations.”

The current rules, which were finalized during the pandemic when public health officials were trying to help people isolate, expire at the end of the year, but it’s not clear whether the Biden administration will be able to find consensus on new rules. HHS and DEA are at odds over the draft proposal, according to a former DEA official who spoke to POLITICO on condition of anonymity to discuss the private deliberations.

The DEA didn’t respond to a request for comment. The DEA has said it is committed to allowing all Americans to access necessary treatments, and wants to balance access with preventing overprescribing. An HHS spokesperson declined to comment, citing the ongoing rulemaking process.

Warner said Congress should be ready to act if DEA isn’t able to finalize a “workable” proposal soon, though he didn’t call for specific legislation.

Nonetheless, Warner has proposed a bill, the TREATS Act, to permanently allow providers to offer virtual treatment for opioid use disorder without an in-person visit. It has 21 Senate backers, including JD Vance (R-Ohio), Lisa Murkowski (R-Alaska) and Ron Wyden (D-Ore.). Telehealth advocates are pushing Congress for a two-year extension of current rules, which apply to a broader range of medicines than just those for opioid use disorder treatment.

The details: Under pandemic-era rules that DEA extended through the end of the year, providers have been able to prescribe most controlled substances seen to pose a risk of misuse — Schedule II-V drugs — without an in-person visit.

The draft proposal would prohibit virtual prescribing of Schedule II drugs — including Adderall for ADHD and methadone for opioid use disorder — without an in-person visit first, unless the prescriber is a specialist.

It would allow patients to get Schedule III, IV and V drugs — including buprenorphine for opioid use disorder, ketamine for depression and testosterone for gender-affirming care — without an in-person visit.

The proposal would also require providers prescribing any controlled substances to check prescription drug monitoring programs intended to prevent diversion in all 50 states. However, a system linking the programs doesn’t connect to every state, a situation which the former official said would make telemedicine prescribing essentially impossible.

The DEA, a law enforcement agency, has raised concerns about venture-funded startups profiting off the eased rules and overprescribing via telemedicine.

The DEA took public feedback on the future of its regulations last September. Some speakers pushed for maintaining the status quo, while others raised concerns about prescribed medicines being diverted for illicit use.

“We’ve experienced a nightmare with the proliferation of telehealth,” said Jerome Cohan, CEO at Catalyst Health Solutions, an addiction treatment clinic with locations in Tennessee and Virginia. “In the wake of Covid, online buprenorphine prescribers started popping up pretty much everywhere … polysubstance abuse has not been addressed with this approach … the idea of not doing a physical exam for somebody who has polysubstance abuse is madness to me.”

The reaction: Opioid use disorder treatment providers and advocates are disappointed by the potential new rules. Most patients with opioid use disorder don’t receive treatment, and buprenorphine — itself an opioid — has shown promise in helping patients wean themselves off more dangerous opioids.

“The public health challenge here is people with opioid use disorder not being on treatment when there is a treatment. Let’s remove barriers,” said Dr. Anand Parekh, chief medical adviser at the Bipartisan Policy Center and an Obama administration HHS official. “Diversion is not a public health challenge. It’s an indication that folks need treatment.”

Dr. Brian Clear, chief medical officer at virtual opioid use disorder treatment firm Bicycle Health, said the proposal effectively bars full-time telemedicine care for opioid use disorder, which he says has shown improvements in outcomes.

He said he’s most concerned about the eased rules lapsing. If that happens, the company would have to immediately stop virtual care and try to connect patients with in-person providers. An Alabama law two years ago forced Bicycle to do something similar, and about half of patients weren’t able to be connected to in-person providers.

“We do not know what happened to these patients,” Clear said. “I would be distraught to see something similar happen nationwide.”

If the draft proposal is finalized, more than half of Bicycle’s team would have to move to part time — meaning it would likely lose a significant portion of its providers, he said.

Libby Jones, program director of the Overdose Prevention Initiative at the Global Health Advocacy Incubator, pointed to a recent National Institute on Drug Abuse study that said telehealth increased the likelihood that patients get treatment.

Dr. Shabana Khan, chair of the American Psychiatric Association’s committee on telepsychiatry, said many practices schedule appointments months in advance, so the uncertainty is the organization’s biggest concern. Khan said there are already guardrails in place to ensure the legitimate practice of telemedicine.

She added that while not commenting on the specifics of the proposal POLITICO reported, restrictions on telemedicine would make it more difficult to recruit psychiatrists to provide care in underserved communities.

“It goes a lot more broadly than opioid and ADHD treatment,” Khan said.

Boulder Care, a telehealth treatment provider, said Congress could take up the TREATS Act.

Some are pushing Congress to go further and put HHS in charge of the rulemaking.

“We have reached a point where stakeholders and lawmakers have a consensus that perhaps this is not the right agency to promulgate this regulation,” said Nathaniel Lacktman, partner at Foley & Lardner and chair of its telemedicine and digital health industry team, of the DEA. “It may be in patients’ and clinicians’ best interest for federal lawmakers to step in and take the reins.”