PHARMACIST STEVE

On Friday, the Drug Enforcement Administration (DEA) proposed new rules to permit the ongoing use of telemedicine to treat patients with opioid use disorder that fail to accomplish their stated objective and will effectively end access to treatment for the 8 million Americans estimated to have OUD.

If these rules move forward as drafted, tens of thousands will experience overdose or other harms from lack of treatment — and many could die.

Unfortunately, this is not my opinion — it is a fact. Cumulative research collected over the past 20 years shows that long-term treatment of opioid use disorder with buprenorphine reduces opioid relapses, overdoses and deaths.

An FDA-approved medication called buprenorphine has been shown to keep people with opioid use disorder from relapsing into problematic opioid use, which, in turn, reduces opioid-related overdoses and deaths and lowers the cost of care for OUD patients by more than 40 percent. When prescribed correctly, buprenorphine saves lives.

In spite of the mountains of research demonstrating the efficacy of OUD treatment with buprenorphine, by January 2020 — in the midst of an opioid epidemic that would claim more than 75,000 lives that year — less than 10 percent of people with OUD were receiving treatment with buprenorphine. For a country as large and wealthy as ours, that number is a disgrace by any measure.

When the COVID-19 pandemic hit in March of 2020, something unexpected happened: The COVID-19 public health emergency (PHE) temporarily waived limitations on telemedicine, making it possible for treatment programs to prescribe Suboxone (a formulation of buprenorphine that prevents misuse) to patients without an in-person visit. Even as the opioid crisis worsened, within a year of opening up access to treatment via telehealth, the rate of opioid-related overdoses and deaths began to decline.

Between January and August of 2022, researchers at CMS and NIH published studies showing that access to medications for opioid use disorder (MOUD) via telemedicine had reduced opioid-related emergency room visits and overdoses. In the eight months between those two studies, access to MOUD via telemedicine was supported by bipartisan leaders in Congress, a bipartisan coalition of state attorneys general and by the Biden White House.

With the PHE ending in May, DEA was required to update their requirements for writing buprenorphine prescriptions via telemedicine, and on Feb. 24, a summary of their proposed rules were published. The net effect of their proposal will restrict access to buprenorphine to a 30-day prescription via telemedicine.

This increases the risks to this vulnerable patient population, and once again, this isn’t my opinion. In 2003 the medical community learned that a 30-day opioid “detox” using buprenorphine has a 100 percent failure rate, compared with a 75 percent success rate for patients who received MOUD treatment with buprenorphine for at least 12 months. Six years later, in 2009, researchers found that 70 percent of OUD patients who tapered off of buprenorphine over a 28-day period had fallen back into illicit use within a month.

No matter how many new studies are run, the outcomes stay the same. Reducing access to buprenorphine increases overdoses, ER visits and deaths.

I’m an adviser to an in-person OUD treatment center that began prescribing Suboxone via telemedicine in 2021. Since the COVID PHE began, that company, Bicycle Health, has expanded to 32 states and treated more than 20,000 patients with opioid use disorder. They’ve had their care model studied by researchers, and while a number of the studies are currently in peer review, two have been published in peer-reviewed medical journals with phenomenal results.

The pieces support that, with telehealth, patients stay in treatment longer (nearly twice as long when care is covered by insurance) than patients treated in-person. Patients also found OUD treatment via telehealth to be easier to access and safer when compared to in-person treatment.

A fair interpretation of DEA’s proposed rule is that the DEA feels telemedicine-only OUD care should remain illegal, even though it’s well-supported to be safe and effective. Their requirement of in-person physical contact with a DEA-registered health care provider in order to continue tele-OUD care has no rational purpose for patient care or safety. There is no medical necessity of in-person contact to provide an OUD diagnosis or prescription. Either the DEA misunderstands the value of direct physical contact in treating OUD or perhaps the unstated goal is to limit buprenorphine access through yet another unnecessary barrier.

There’s no question that access to MOUD treatment via telehealth needs to be regulated, but the DEA is flat-out wrong with this initial draft. Even if you put the data to the side for a moment, and just think about the human aspect of this problem, restricting access to care is morally reprehensible.

Unlike the COVID public health emergency, where we labored without effective treatment options for more than a year, the opioid public health emergency has increased in intensity for years with a highly effective treatment option available that is massively under-utilized.

I believe these kinds of regulatory missteps could be avoided if the Biden administration had followed the recommendations of the Bipartisan Mental Health and Substance Use Disorder Task Force — and 51 other members of Congress — and reinstated the director of the Office of National Drug Control Policy (ONDCP) to a Cabinet-level position. Since the position was removed from the Cabinet, deaths from overdose in the U.S. have more than doubled.

In the absence of Cabinet-level leadership here, it is my sincere hope that lawmakers in Washington, D.C., and at the state level push back on the DEA in support of commonsense regulations on MOUD treatment via telehealth. Congress can come together, increase access to care and save people’s lives.

Patrick J. Kennedy is a former Democratic congressman and the co-founder of One Mind, a nonprofit focused on mental health. Patrick is an advisor of Bicycle Health, a provider of virtual opioid use disorder treatment and was a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. He represented Rhode Island’s 1st Congressional District from January 1995 until January 2011.