HHS’s New Rule: Raising the Patient Limit on Buprenorphine


The Department of Health and Human Services (HHS) has proposed a rule in March 2016 that would allow certified practitioners to prescribe buprenorphine (an opioid) to as many as 275 patients per physician in order to treat opioid use disorder.  In the past, SAMHSA proposed that certified physicians could prescribe buprenorphine for Medication-Assisted Treatment (MAT) for up to 30 patients initially, and up to 100 patients after one year.

The evidence-based MAT, buprenorphine or Suboxone, was under-utilized previously, and many practitioners were limited in their ability to assist patients in need of treatment due to the restriction. Centers for Disease Control and Prevention (CDC) guidelines advise caution in using opioid drug therapy to combat the problem and provide specific treatment guidelines to certified physicians while the SAMHSA rule expands patient access to medication assisted treatment. American Society of Addiction Medicine (ASAM)  and American Psychiatric Association (APA) applaud this policy change and call it ‘long overdue’ as an important step to help combat the current epidemic of opioid addiction and overdose deaths. Buprenorphine drug satisfies cravings without the euphoria that drives drug-seeking behavior.

The abuse and addiction to opioids, such as heroin, is reportedly increasing all over the USA. In 2013, an estimated 289,000 people in the US used heroin. The mortality from unintentional prescription opioid overdose has been quadrupled from 1999 to 2014, and deaths related to heroin have escalated 39% between 2012 and 2013. In Maryland, the number of heroin-related deaths more than doubled between 2010 and 2014. Approximately, 86% of all intoxication deaths that occurred in Maryland in 2014 were opioid-related.

An increase in patient cap will permit certified physicians to give patients greater access to buprenorphine. Approximately 2 million who are dependent on heroin and in favor of seeking treatment will benefit from this new rule. In July 2016, Congress has passed the Comprehensive Addiction Recovery Act (CARA) which not only expands access to buprenorphine to certified physicians but also to nurses and physician assistants to be able to prescribe buprenorphine.

Although it is hard to predict how successful of an outcome this rule will generate, the outlook thus far has been optimistic.

7 Responses to “HHS’s New Rule: Raising the Patient Limit on Buprenorphine”

  1. mtait0508 Says:

    This is an interesting post and I wonder how the proposed rule will impact public opinion of providers. I was not familiar with the limitations imposed on clinicians prescribing opioids, but aware that many place blame for the current crisis on providers and profligate prescribing practices. Do you think this proposal will in any way impact public opinion?

    • Umar Jawaid Says:

      If only the qualified physicians get the rights for the increase, we will be ok. If the flood gates open to the mid level practitioners, then comes the pill mills!

  2. angelalamacchia Says:

    It’s needing that there were lists on this in the first place. How did they police such activities? Tracking what and how many people prescribers prescribed to must have been tricky.

    As am emergency physician I find the concept of suboxone/buprenorphine tricky. Often patients o this substance will present to the ED wanting a repeat prescription and it is difficult to know if they’re doubling up. Additionally, if they present with pain for some other reason, such as being in a trauma, they are excessively difficult to treat. This is not just because of tolerance but also because of buprenorphines partial antagonist action which blocks the effectiveness of other opioids. I haven’t specifically looked into the effectiveness of opioid substitution but I know there are mixed reviews and I err on the side I of skepticism….

  3. BreastfeedingChampion! Says:

    This is great. Having grown up in the south east United States, I have a lot of friends back home. After laws passed limiting opiate pain medication prescriptions, heroin came into my hometown. Now, this summer there has been an epidemic of people overdosing on heroin that is now laced with fentanyl. A large part of the problem that arose from not increasing addiction services and not doing anything to combat the stigma of addiction. The laws created a huge hole in the market leaving room for much more nefarious opiate sources to arise.

  4. Umar J Says:

    If the heroin abuse continue to rise, it would be a challenge to control the opioid in baltimore or in other parts of US. This rule may help. We would know how effective this policy is with time. lets hope for the best!

  5. harveyksite Says:

    Great post! I have the privilege of working with current and formally homeless individuals and many of them are on some form of opioid replacement therapy. Those on Suboxone, who use it appropriately, seem to be very successful at returning to work, freeing them from the restrictions of more traditional opioid replacement (methadone). I think it is a great idea to expand this program. Eventually, it should be incorporated into general primary care. The opioid addition issue is much greater than we want to admit and primary care providers are going to have to step up and start viewing these patients as individuals with chronic illness and manage them the way they do with other issues. There are long acting delivery systems that have been developed that will make management of this issue easier for the general provider. Thanks again for posting!

  6. Umar J Says:

    I agree. thanks for liking my post. Now, the next big challenge is to encourage the physicians (primary care) to use naloxone (narcan) more often than it’s done in current clinical practice. The price of this medication should be affordable as well.

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