Acetaminophen/Oxycodone Hydrochloride

More than 330 healthcare organizations signed letters this week urging the White House and Congress to extend a telehealth prescribing flexibility that was introduced during the Covid-19 pandemic. Failure to extend this policy would cause millions of Americans to lose access to “critically important healthcare treatment,” the organizations wrote. In 2020, Congress waived a rule that required an in-person visit to establish a relationship between a patient and their provider before any prescriptions can be given via telehealth. The Drug Enforcement Administration had originally planned to roll back this flexibility last year, but the agency extended it through the end of 2024 after receiving more than 38,000 comments on its proposed rule. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani For nearly four years now, providers have been using the telehealth prescribing flexibility to prescribe controlled substances. These include Schedule II drugs, such as stimulant medications to treat ADHD like Adderall and Vyvanse, as well as opioids like Percocet and Dilaudid. These also include Schedule III-V controlled substances, such as common psychiatric drugs like Xanax, Ambien and Prozac, as well as drugs that treat substance use disorder like buprenorphine. The DEA is still working on a new proposed rule that will dictate whether or not providers can prescribe controlled substances via telehealth after this year — but last week, its plans were leaked by media outlets. The agency’s rule — which is not final and is currently being reviewed at the White House — is definitely not what telehealth advocates were calling for. The rule would get rid of providers’ ability to prescribe Schedule II drugs via telehealth without a prior in-person appointment — either by establishing new regulations or simply allowing the pandemic-era flexibility to expire at the end of the year. On the other hand, Schedule III-V drugs would still be allowed to be prescribed via telehealth without an in-person visit. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Additionally, the unpublished rule would require that no more than half of a provider’s prescriptions may be given via telehealth appointment. It also includes a mandate for prescribers to check all 50 states’ prescription drug monitoring programs before writing a prescription for a patient with whom they have never had an in-person visit. However, enforcing this requirement will be difficult, as providers say there is no national registry where providers could easily check whether or not the patient had obtained a prescription for the drug in another state. Many provider organizations have reacted to the leaked rule with outrage. On Tuesday, more than 300 groups sent separate letters to the White House, Senate and House, imploring them to roll back the strict rules that the DEA is reportedly planning to propose. Some of these organizations included Amazon, Cleveland Clinic, Mass General Brigham, Hims & Hers Health, the American College of Physicians, and the National Rural Health Association. “The ongoing challenges in accessing mental health and substance use treatment services, particularly in rural and underserved areas, underscore the importance of maintaining these flexibilities. More than half of U.S. counties do not have a psychiatrist. The shortage is even more prominent in rural areas, with nearly three quarters of rural counties lacking a psychiatrist,” read the groups’ letter to the White House. Extending the prescribing flexibility would mean that millions of patients in these underserved areas would get to keep their access to treatment, the organizations argued in their letter. The letter also pointed out that there is very little time to make this happen. “Given how late we are in the year and with the waiver expiring on December 31, there is very little time left for the DEA to release a draft rule for public comment, close the comment period, review the substantive feedback, and finalize the rule in time for the end of the year. Nearly 40,000 comments were submitted last year when the DEA first attempted to draft rules for a permanent framework on remote prescribing of controlled substances,” it read.

This month, the U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) took steps to expand access to opioid use disorder treatment through its new final rule, which includes a provision that permanently allows for the initiation of treatment (methadone and buprenorphine) via telehealth. However, the final rule narrowly applies to only practitioners working in Opioid Treatment Programs (OTPs) and does not include other providers like primary care physicians and addiction medicine specialists. Telehealth advocates applaud HHS’ final rule but say further action needs to be taken by the Drug Enforcement Administration (DEA) to more broadly expand access to treatment via telehealth. While HHS and SAMHSA have jurisdiction over OTPs, the prescribing of controlled substances is under the DEA’s jurisdiction. OTPs are clinics licensed by a state’s health department and require federal accreditation to dispense medication-assisted treatment (MAT) services. The telehealth capabilities for OTPs began during the Covid-19 pandemic when it was more difficult to seek treatment in person. Under the final rule, practitioners in OTPs can start patients on methadone via an audio-visual telehealth appointment and start patients on buprenorphine via an audio-only telehealth appointment. The final rule doesn’t allow for an audio-only appointment for methadone because, compared to buprenorphine, it “holds a higher risk of sedation, especially if taken by someone who already is experiencing some drowsiness,” according to the SAMHSA. In addition to the telehealth changes, the final rule also allows patients to receive take-home doses of methadone and expands provider eligibility to allow nurse practitioners and physician assistants to order medications in OTPs. It also removed criteria that required patients to have a history of addiction for a full year before being eligible for treatment. “The easier we make it for people to access the treatments they need, the more lives we can save,” said HHS Deputy Secretary Andrea Palm in a statement. “With these announcements, we are dramatically expanding access to life-saving medications and continuing our efforts to meet people where they are in their recovery journeys.” What the final rule does not include is the virtual prescribing of a broader range of controlled substances in addition to buprenorphine, such as Adderall, Percocet and Xanax. The rule also does not apply to a broader range of providers, such as primary care providers, psychiatrists and virtual providers. The DEA released a proposed rule last year that would roll back Covid-19 flexibilities that allowed a range of practitioners to prescribe controlled substances virtually. However, after receiving a record number of comments, the agency has extended the flexibilities through December of this year. And now with HHS issuing this final rule on OTPs, some are hoping the DEA will expand who is eligible to provide care through telehealth and make these flexibilities permanent. While the final rule is “really important,” one telehealth advocate is left wanting more. “We hope that this forward-looking access to care that’s been achieved through this final rule will be something that is taken up by the DEA, working in conjunction with SAMHSA on this broader overarching policy that we still don’t have a permanent foundation for. … SAMHSA has applied lessons learned to ensure appropriate levels of access for those patients who will go to treatment centers,” said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, in an interview. He added that he hopes the DEA “exceeds” what SAMHSA has done when it comes to the virtual prescribing of controlled substances. One provider who is not affected by HHS’ rule and is awaiting direction from the DEA is Bicycle Health. The Boston-based telehealth company currently offers access to buprenorphine and treats patients across 32 states. Dr. Brian Clear, chief medical officer of the company, said “it’s about time” that the HHS final rule was passed, but noted that there are limitations. In March of 2021, there were just 1,816 OTPs in the U.S., according to Pew Charitable Trusts. That just barely scratches the surface of the need when it comes to opioid use disorder. Clear argued that HHS and SAMHSA’s rulemaking is based on evidence from primary care providers and programs like Bicycle Health that shows virtual prescribing of buprenorphine is safe and effective. Therefore, it would be “absurd” if the DEA decides providers like Bicycle Health can’t also prescribe treatment virtually. Another virtual opioid use disorder provider also cheered the final rule while echoing Clear and Zebley on its limitations. “There are significant ways in which this final rule can help expand access to OTP services, but challenges also remain for patients who want or need low-barrier access to medication-based treatment for SUD,” said Ben Maclean, general counsel at Portland, Oregon-based Boulder Care. What specifically should the DEA do to expand access? Zebley of the American Telemedicine Association said the agency should create a special registration process that allows medical professionals to register with the agency in order to virtually prescribe controlled substances. Congress mandated the DEA to create this process back in 2008, but the agency has yet to do so. Zebley said it’s “dangerous to make too many predictions” about whether the DEA will follow HHS’ footsteps. However, he noted that the virtual prescribing of controlled substances has now been allowed for four years. By the time the extension ends in December, it’ll be just shy of five years. “Why would we throw the door back up, gates back up, build that wall back up and leave a lot of vulnerable patients out in the cold? I do think it is a life or death circumstance for some,” he said. “Some Americans receiving care now will have their continuity of care severed and some Americans in the future will never have this opportunity to have that level of access to care that they need when and where they need it.”