Telehealth prescribing mess could reach Congress

• With the clock ticking and little time left for rulemaking, providers and health tech companies want Congress to enact a two-year fix maintaining the status quo as part of a year-end health deal.

The big picture: Telehealth is already front and center in policy discussions, as expanded Medicare coverage of telehealth services that's been in place since the beginning of the pandemic is also due to expire at year's end.

• Meanwhile, patients are struggling with shortages of Adderall and other amphetamines like Vyvanse, and providers say access could be curbed even more if old limits on telehealth prescribing are restored.
• Any year-end telehealth fix could boil down to cost, because even a short-term continuation of the pandemic-era flexibilities could cost billions.

State of play: The DEA last year temporarily extended a waiver on telehealth prescribing of controlled substances through the end of this year after receiving thousands of negative comments in response to a plan to go back to requiring an in-person visit.

• The agency is concerned about the possible diversion and misuse of the substances. Testosterone is included in the cohort, as a steroid classified as a Schedule III controlled substance.
• The DEA sent a revised proposal to the White House for review back in June and could do another short-term waiver while it finalizes a new policy.
• But HHS reportedly has objections to the rule, which would exclude Schedule II controlled substances, make providers write 50% of controlled substance prescriptions in person and set other requirements, per Politico.
• The DEA and White House did not respond to questions on the proposal's status.
• HHS, in a statement, said it's committed to working with its federal partners and stakeholders and that it believes "improved access to mental health and substance use disorder services through continued telemedicine flexibilities will save lives."

More than 330 organizations including Mass General Brigham, the American Psychiatric Association and the Association of American Cancer Institutes wrote to congressional leaders last week asking for a two-year extension of the flexibilities.

• They also asked the White House to compel DEA to continue the pandemic-era policies, which would eliminate the need for Congress to get involved.

Case in point: Before the pandemic, Bicycle Health had a single brick-and-mortar clinic in California that provided buprenorphine treatment for substance use disorder to a couple of hundred patients, chief medical officer Brian Clear said. Thanks to the current telehealth flexibilities, the company now treats about 13,500 people, he said.

• "If these waivers expire, we can't do that. We have to go back to in-person practice, and all these advances get wiped away," Clear said.

Zoom in: At the heart of the issue is a debate over how to make sure patients have easy access to important medications while minimizing the potential for drug diversion and making sure the drugs are prescribed responsibly.

• Indeed, the DEA is suing executives of telehealth startup Done Health for illegitimately prescribing controlled substances.
• But doctors say regulators should let them use discretion to decide when an in-person visit is necessary.
• State and federal regulations already include guardrails to make sure providers use telehealth appropriately, and remote monitoring technology can help test vitals when needed, said Shabana Khan, chair of the American Psychiatric Association's committee on telepsychiatry.

Khan and her colleagues are starting to schedule patients for in-person visits in case the telehealth prescribing rules expire in after December. But that's not possible for everyone.

• "Unfortunately, for many that care will come to an abrupt end with devastating consequences," Khan said in an email.