Opioid Overdose Deaths Drive New Initiatives From Biden’s HHS

Biden administration plans to allow take-home use of opioid addiction treatment drugs and ease the sharing of substance users’ medical records are steps in the right direction if done carefully, health experts say.

The administration’s evidence-based approach to opioid addiction focusing on lowering harm and increasing support for recovering addicts is novel, health experts say. Its proposed rules on treatment and record-sharing aim to halt the number of overdoses that has largely trended upward since 2015, peaking at about 110,000 predicted deaths in the year leading up to March 2022.

“The people in charge now are very committed to bringing down overdose death rates” and “building out the type of system that we need in this country to respond to addiction,” said Regina LaBelle, previously acting director in the White House’s Office of National Drug Control Policy (ONDCP).

The rule proposals “are emblematic of that,” said LaBelle, now director of the Addiction and Public Policy Initiative at Georgetown’s O’Neill Institute for National and Global Health Law. “They’re taking it very seriously.”

Yet experts also caution that the success of the rules requires a careful balance of patient need and services provided.

Striking a Balance

The records proposal would allow health-care providers to share a patient’s substance use treatment records after a one-time consent, aligning the more rigid substance use record requirements with standard health information requirements under the Health Insurance Portability and Accountability Act of 1996, or HIPAA.

The Health and Human Services Department rule proposal (RIN 0945–AA16) was required under the Coronavirus Aid, Relief, and Economic Security (CARES) Act and is intended to enable medical professionals to better coordinate care.

But there’s “reasonable disagreement in the field about how best to strike a balance in terms of ensuring medical records flow to the places where they can help guide patient care” while providing “protection against addiction stigma,” said Brendan Saloner, associate professor at Johns Hopkins Bloomberg School of Public Health.

Life insurance, health insurance, employment, and child custody are among the things that health experts say could be compromised should substance use treatment records fall into the wrong hands, a big problem given that records are permanent.

“We have to be cautious about how these issues are shared with people inside the direct treatment system,” said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence.

“I don’t think any treatment program or regulatory agency should make assumptions that a patient would give consent,” he said.

Presidential Pushing

When it comes to grappling with addiction, “the past four administrations have all been playing catch-up,” Saloner said.

According to the HHS, the late 1990s saw an increase in health-care providers prescribing opioids, while drugmakers said patients wouldn’t get addicted.

Presidential administrations have since tried to get a grip on what exploded into a crisis. For example, the Obama administration’s Affordable Care Act included substance use disorder treatment as an essential health benefit.

The Trump administration appointed an opioid commission in 2017 and declared the opioid crisis a national public health emergency. That same year, however, the administration disbanded the commission, and also attempted to cut the Office of National Drug Control Policy’s budget by 95 percent.

Shortly before leaving office, President Donald Trump put out an order to loosen requirements for doctors to prescribe buprenorphine and methadone.

Broadly, Trump’s plan was “more robust than I and the larger industry anticipated,” Tom Britton, CEO for American Addiction Centers, said, though “execution was not really that evident.”

The Biden administration, however, quickly reversed course, claiming Trump lacked the legal authority to expand treatment access by updated federal guidelines and drawing heat from patient advocates.

Since then, however, the Biden administration has drawn praise for its efforts at curbing addiction.

ONDCP in 2021 gave what the White House called the “largest single-year investment” in the history of the Drug Free Communities program, offering up over $93 million for efforts across the US. Likewise, in 2021, the National Institutes of Health announced a clinical trial using mobile health vans, while this November, the Food and Drug Administration announced it was assessing whether to allow naloxone access without a prescription.

The ‘Right Patient’

The treatment proposed rule (RIN 0930–AA39) would allow programs to dole out take-home doses of the powerful methadone opioid treatment drug and lower what the administration considers other barriers to care.

The methadone rule marks a “massive departure” from how the government has handled addiction treatment, spurring “a lot of controversy both within and outside the field,” Britton said.

Methadone is “a therapeutic medicine for the right patient but is also a highly addictive substance. It can easily be diverted and given to other people for illicit street drugs,” Britton said. Still, the plan is “a very good idea,” in so long as it’s “with the right patient.” That means someone who has demonstrated stability and been in long-term monitored recovery.

Use of addiction treatment drugs is increasing, according to HHS research released a year after the administration in late 2021 launched its Overdose Prevention Strategy.

The number of health providers with waivers for prescribing buprenorphine for treating opioid use disorder increased nearly 20% in the past year, from 110,491 in October 2021 to 132,004 in September 2022. Meanwhile, the number of prescriptions filled by pharmacies for the opioid overdose reversal drug naloxone has gone up by 37%, with a three-month average of around 109,000 in October 2021 reaching over 150,000 in August 2022.

But “methadone has a more complex safety profile than buprenorphine,” Saloner said. “Patients can overdose on methadone and if not stored properly, it can be ingested by children or other people.”

Loosening restrictions on methadone isn’t without precedent. In March 2020, the administration relaxed patient eligibility requirements for take-home drugs, including methadone.

In the context of the Covid-19 public health emergency, easing access to take-home methadone is “well worth the tradeoff,” Saloner said. But “we need to do more research to see whether these unintended consequences arise.”

Problems Ahead

In December, the administration put out its “Non-Fatal Opioid Overdose Surveillance Dashboard,” tracking rates across states, naloxone administrations and more.

The dashboard pegs the number of overdoses in the past year as around 175,000, with roughly 21 percent of patients not being transported to a medical facility.

“The status quo isn’t working. We’re faced with increasing rates of overdose deaths. It’s time for this type of change to take place,” LaBelle said.

In LaBelle’s view, methadone rules are currently considered too much from a legal rather than clinical perspective. The HHS’ proposed rule essentially grants more powers to doctors to make the call.

“The law is about black and white rules to ensure certainty,” Labelle said. “Clinicians can’t treat every single patient the same, and I think that’s been one of the issues with methadone treatment.”

The public has to weigh in before the rule goes into effect. Once finalized, Parrino noted that “the real question is going be alignment in policy making between federal authorities and the states. That’s where the rubber meets the road.”

“There are about 20 states, maybe a few more that actually are more restrictive than existing SAMHSA regulations’,” he said, referring to the HHS’ Substance Abuse and Mental Health Services Administration.