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.

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.

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.

Presidential Pushing

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.

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.

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.

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.”

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.

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 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.”

Source: Bloomberg Law