Obama Expands Buprenorphine, Naloxone Use to Fight Opioid Epidemic

Regulatory NewsRegulatory News
| 29 March 2016 | By Michael Mezher 

President Barack Obama on Tuesday introduced new measures to expand access to drugs used to treat opioid addiction.

Specifically, states will see increased access to two opioid addiction drugs, buprenorphine and naloxone, and Obama announced the launch of a new interagency task force to ensure treatment parity for patients seeking help.

In recent years, a growing number of Americans have become addicted to opioids and heroin. According to the Centers for Disease Control and Prevention (CDC), more than 28,000 Americans died of opioid overdoses in 2014, which is more deaths than from car crashes.

Speaking at the National Rx Drug Abuse Summit in Atlanta on Tuesday, Obama said: "The most important thing we can do is reduce demand for drugs, and the only way that we reduce demand is if we're providing treatment and thinking about this as a public health problem, and not just a criminal problem."

Earlier this month, the US Food and Drug Administration (FDA) and CDC issued measures of their own to fight opioid abuse, including new labeling requirements, draft guidance to guide the development of abuse-deterrent generic opioids and long-awaited opioid prescribing guidelines.

In February, Obama also announced he would request $1.1 billion in new funding to aid state efforts to treat patients with opioid addition as part of his FY2017 budget. Speaking at the summit, Obama urged Congress to allocate the funds he's requested.

"Very rarely is money the solution alone … but money helps, and without it … what we will repeatedly end up with is being penny-wise and pound-foolish," Obama said, warning of the cost of untreated addiction and incarceration.

Sen. Patty Murray (D-WA) applauded the new measures on Tuesday but cautioned that more must be done to fully address the opioid epidemic.

Expanding Access to Buprenorphine

One of the ways the Administration hopes to address the epidemic is to double the limit on how many patients a prescriber can treat at a time with buprenorphine – from 100 to 200. Buprenorphine is approved by FDA to treat opioid dependence, and works by helping manage withdrawal symptoms while a patient is in recovery.

To do so, HHS has published a proposed rule for comment in the Federal Register, under which physicians will be allowed to apply for a waiver to treat up to 200 patient after they have had 100 patient waivers for at least one year.

In order to qualify for the 200 patient limit, practitioners must be board certified in either addiction medicine, addiction psychiatry or meet requirements as a qualified practice setting under the rule. Additionally, to maintain the higher limit, practitioners must demonstrate their ongoing eligibility, and comply with new reporting requirements.

"This proposed expansion is especially important to people who are seeking help for an untreated opioid use disorder," said Substance Abuse and Mental Health Services Administration Principal Deputy Administrator Kana Enomoto. "In many cases there are long patient waiting lists for prescribers who have reached the 100 patient limit. Easing barriers to treatment is a major step to reducing prescription opioid and heroin related overdose, death, and dependence."

The administration is also providing states with a total of $22 million to fund medication-assisted treatment services. Half of that funding will specifically be used to purchase and distribute naloxone, which is used to reverse the effects of opioid overdose in emergency situations.

Additionally, the President signed a memorandum on Tuesday, dictating the launch of a new interagency task force with the goal of promoting best practices for addiction treatment and ensuring that health plans cover addition treatment in a way that's on par with their coverage of other medical interventions.



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