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The Biden Administration Plan for Treating Opioid Use Disorder in the US: Is There One?

March 3, 2021
Federal efforts to increase medication-assisted treatment access and reduce the rate of opioid overdoses seem slow to roll out. Meanwhile, patients are struggling.

In late January 2021, just about a week after President Biden took office, more than a dozen major medical groups, including AMA and ASRA, published a letter to the Department of Health and Human Services urging that the new administration “take steps to eliminate federal policies that inhibit access to vital treatment” to the nation’s other ongoing crisis, the opioid epidemic.1 The vital treatment: buprenorphrine for opioid addiction.

Buprenorphine is considered one of the most important medicines in the arsenal for treating opioid use disorder (OUD) yet the federal government continues to issue, and retract, waiver requirements that give prescribers more access to the treatment.

Buprenorphine’s Relevance in the Face of X Waiver Requirements

This letter came after the Biden administration overturned new practice guidelines that had relaxed X-Waiver requirements for prescribing buprenorphine – an initiative pushed through in the last days of the Trump administration.2  Now a month after halting this guideline, confusion remains among providers (see our latest column from APPs Theresa & Jeremy on the Data Waiver) and it’s unclear how the current administration will honor its promise to, “pursue comprehensive strategies to expand access to treatment, particularly in rural and urban communities with high rates of substance use disorders and a lack of access to substance use disorder treatment services,” as outlined in the Biden Plan to End the Opioid Crisis.3

Buprenorphine is considered a crucial medicine in the arsenal for treating opioid use disorder (OUD).1 A recent study, published in Addiction, found that people receiving medication-assisted treatment (MAT) – including buprenorphine and methadone – for OUD had an 80% lower risk of dying from opioid overdose than those receiving addiction treatment without medication.4

A partial opioid agonist, buprenorphine can be prescribed as an outpatient medication (unlike methadone) and has proved particularly useful during the COVID-19 pandemic, when federal guidelines temporarily permitted buprenorphine prescription via telemedicine – by prescribers with an X Waiver. However, as of 2019, only 70,020 practicing physicians in the US held an X Waiver, severely limiting access to treatment, especially in rural areas.5 Indeed, 39% of counties across the United States do not have a buprenorphine prescriber who can issue the drug.6

“Buprenorphine has become so much more relevant during the pandemic because access to nonmedical support [and] to live meetings has been compromised,” says Jay Kuchera, MD, FASAM, who is board certified in pain medicine, addiction, and anesthesiology. Indeed, this past year has shown historically high rates of deaths related to drug overdose – over 8,1000 between June 2019 and May 2020, according to preliminary data from the CDC.7 In fact, the climb has prompted authorities to push to expand the use of naloxone and overdose prevention education.

While practitioners wait for a clear path forward, many are turning their attention to Biden appointees and what their initiatives may mean for the future of pain management and, in particular, OUD treatment.

To Date: Waiting on Opioid Treatment Progress by FDA, ONDCP, DEA

 All eyes are on key government agencies and offices – the FDA, DEA, and the White House Office of National Drug Control Policy (ONDCP) – all without permanent leadership at the time of this writing.

Acting FDA Commissioner Janet Woodcock, MD, has been widely criticized for her previous role as head of the FDA department responsible for approving new drugs including prescription opioids, the Center for Drug Evaluation and Research (CDER). A 2017 report from the President’s Commission on Combatting Drug Addiction and the Opioid Crisis cited “inadequate oversight by the Food and Drug Administration,” and the National Academy of Sciences (NAS) publicly called on the FDA to overhaul its opioid policies.”8,9

In the ONDCP, the Biden administration has not yet named a permanent head, popularly known as the Drug Czar. The acting director, Regina LaBelle, JD, served as Chief of Staff and senior policy advisor in the ONDCP during the Obama Administration. Labelle has been a frequent contributor for The Hill and in a 2019 opinion piece cited the NAS statement that “medications for opioid use disorder (methadone, buprenorphine, and naltrexone) save lives.”10

The ONDCP has issued some language, putting harm reduction at the forefront of its policies, perhaps for the first time. Their three reported priorities are:11

  • Advancing recovery-ready workplaces and expanding the addiction workforce
  • Supporting evidence-based prevention efforts, related to both supply and demand reduction
  • Expanding access to evidence-based treatment, including by lifting burdensome restrictions on medications for opioid use disorder.

“Confronting racial equity issues related to drug policy,” is also listed as an ONDCP priority – again marking a national shift in approach.11 The Office used social media to affirm these priorities in February12  and, while these announcements bode well for prescribers seeking greater access to MAT, no formal policies have been announced.

Over at the DEA, Acting Administrator D. Christopher Evans, seems focused on preventing the unlawful dispensing of opioids. The agency made waves in February by bringing civil charges against Tampa-area physician, pharmacy, and clinic owners for Controlled Substances Act violations. The news suggests a Biden plan that may signal a focus on prosecution of prescribers over treatment of patients, but again, no formal policies have been issued.13

Legislation To Support Buprenorphine Maintenance, Detoxification

Could legislation lead to quicker action on addressing opioid overdoses (which have stemmed primarily from illicit drugs) and addiction treatment?

A bipartisan bill in Congress seeks to do just that. H.R. 1384, introduced by US Rep Paul Tonko (D-NY), aims to “eliminate the separate registration requirement for dispensing narcotic drugs in Schedule III, IV, or V (such as  buprenorphine) for maintenance or detoxification treatment, and for other purposes.”14

In the meantime, says Dr. Kuchera, “We must affirmatively retire the X Waiver and direct providers to resources like the Providers Clinical Support System (PCSS). A program of SAMHSA, the PCSS healthcare consortium aims to train primary care providers in the prevention and treatment of OUD and chronic pain.

Practitioners can prepare to be able to deliver MAT to patients, once it is more widely available. Dr. Kuchera recommends programs offered by academic institutions, such as the University of California San Francisco’s National Clinical Consultation Center as well as the national and state Opioid Response Network. While the programs do not certify an X Waiver, they do offer guidance and up-to-date information on substance use management.

Overall, a quick glance at the White House’s official website affirms that the opioid crisis is not one of the “Biden-Harris Immediate Priorities.”15 Meanwhile, as both practitioners and advocacy groups rally for increased access to overdose prevention and addiction care, many patients face a void of accessible medical intervention.

See also, how drug monitoring has fared during the pandemic.           

Last updated on: March 4, 2021
Continue Reading:
Case Report: How We Grew Our Pain Practice Amidst Pandemic, Opioid Crisis
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