October 11, 2024
(Politico NY Health Care 10/11/24)
New federal regulations permanently loosening requirements for opioid treatment programs could significantly increase access to methadone across New York, according to state Office of Addiction Services and Supports Commissioner Chinazo Cunningham.
Cunningham, at a symposium Thursday spearheaded by the Coalition of Medication Assisted Treatment Providers and Advocates of New York State, was optimistic about the “sweeping” changes under the final rule to long standing regulations around medication-assisted treatment for opioid use disorder.
Those changes include telehealth authorization for methadone and buprenorphine, as well as increased flexibility for prescribers around methadone dosing.
“This is an unprecedented time in terms of the investment in the field of addiction and the regulatory changes, which both bring real potential opportunities to change people’s lives,” Cunningham said. “I’m very excited about this opportunity.”
She specifically touted plans for 32 new comprehensive opioid treatment programs and nine mobile medication units statewide.
Notably, the two mobile medication units already up and running — both in New York City — are so far treating greater proportions of Hispanic and Black people than the brick-and-mortar opioid treatment programs that have units in the works.
The early data are significant in light of the fact that rates of fatal overdoses are highest among Black New Yorkers, Cunningham said.
But remaining hurdles at the federal level pose challenges for further expansions, Cunningham said, noting that opioid treatment programs have struggled to obtain the DEA approval needed to get those vans up and running.
But she pointed to an ongoing project that aims to increase access to medication treatment in the meantime: The state is planning to restructure its financing of addiction services with the help of consulting firm Third Horizon Strategies.
—————————–
| DEA Rule Extending Telehealth Prescribing May Be Nearing Release |
|
Earlier today the Drug Enforcement Agency (DEA) signaled that the agency is set to once again extend flexibilities that permit the prescribing of certain controlled substances via telehealth. A final rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” reached the White House Office of Management and Budget (OMB) yesterday, indicating that the rule may be released soon. Through pandemic-era regulations previously extended by the DEA until the end of the year, providers can prescribe most controlled substances (Schedule II through IV drugs) without requiring an in-person appointment. With these flexibilities expiring at the end of 2024, more than 300 organizations, including National Council, the Alliance for Connected Care, the NYS Council for Community Behavioral Healthcare and many others, have called on Congress and the DEA to extend the rules without further restrictions. It is unclear exactly when, or if, the rule will be cleared by the White House, however providers and advocates will continue pushing for clarity as soon as possible in order to avoid any pause or disruption in patient treatment. (Politico Pro, 10/11/24) The Drug Enforcement Administration is signaling it will again extend temporary rules allowing the prescribing of controlled substances via telemedicine. A final rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” reached the White House for review Thursday. It’s not clear how long the extension would be for. The potential punt also means either a Kamala Harris or Donald Trump administration will have to deal with the issue. During the pandemic the DEA relaxed certain restrictions, allowing many controlled substances including Adderall and testosterone to be prescribed without an in-person visit, but those allowances are set to expire at the end of the year. POLITICO first reported that the DEA intended to impose substantial limits on providers’ ability to prescribe controlled substances virtually in what would have been a significant blow to the telehealth industry. HHS and DEA have been at odds over the draft rule, which has not been published. The draft rule allowed no more than half a provider’s prescriptions to be given virtually. The DEA’s plan sparked significant blowback from members of Congress, some of whom had been plotting a legislative fix, and from addiction and mental health treatment advocates. More than 300 organizations, including the Alliance for Connected Care and American Telemedicine Association, called on Congress to extend the rules without further restrictions. The history: Under pandemic-era rules that the 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 POLITICO reported earlier this year 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, according to a former DEA official granted anonymity to discuss an unreleased draft. The draft proposal made exceptions for certain drugs, such as buprenorphine for opioid use disorder, ketamine for depression and testosterone for gender-affirming care — without an in-person visit. It 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.If an extension is finalized, this would be the second time the DEA has floated tightened rules and retreated amid backlash. In February 2023, the agency proposed rolling back eased rules ahead of their expiration along with the public health emergency but reversed course and extended the rules after receiving an agency record 38,000 comments, many of them negative, and significant industry pressure.The DEA has raised concerns about overprescribing via telemedicine and has said it’s trying to strike a balance between access to treatment and guardrails against misuse.The Justice Department this summer indicted top executives at digital health firm Done on charges related to overprescribing stimulants for ADHD. Prosecutors allege the two executives conspired to structure the platform to offer “easy access” to stimulants, including by mandating initial visits be less than 30 minutes and prescribing Adderall even if the member didn’t qualify. The company has denied wrongdoing. What’s next: It’s unclear when, or if, the rule will clear White House review and be published. Telemedicine providers have been pushing for clarity as soon as possible to avoid disruptions. |