The opioid problem won’t wait.  Seventy-eight people die every day in the United States from an opioid overdose.  Nearly 2.2 million Americans struggle every day with an addiction to opioid pain medications or illegal opioids like heroin.  Opioid addiction, also called opioid use disorder, is a complex disease associated with chronic drug use, high-risk behavior, and a host of other medical and behavioral complications. 

Recovery is possible. The good news is that we have treatments that we know are effective, using a combination of medication, counseling and other supports – known as medication assisted treatment (MAT).  The more disappointing news is that more than half the people who could use treatment are not able to get it, in large part because they can’t afford it or can’t find providers.  We can do better and we must.

The Department of Health and Human Services is taking bold steps to improve access to treatment, especially to MAT with buprenorphine, methadone and naltrexone.  The federal government cannot address all the barriers to treatment, but we will take action where we can to make it easier for people to get the treatment that can turn their lives around – and often times save their lives.

The proposed regulation we issued this week seeks to ease one of these barriers – the limit on the number of patients a physician can treat with buprenorphine at a given time.  Right now physicians can only treat up to 100 patients at a time with buprenorphine.  While this limit has increased over time (the Drug Addiction and Treatment Act of 2000, DATA 2000, limited physicians to 30 patients), one might wonder why there is a limit at all. We have heard from physicians, addiction specialists and others that the caseload limit of 100 is too low and can mean that some people who need treatment do not get it. 

One concern with increasing the limit is that prescription opioids are commonly diverted for nonmedical purposes meaning they are passed on or sold to people who are not under treatment to be used as an opioid themselves.  The buprenorphine prescribing limits are in place, in part, to minimize further diversion of buprenorphine.

What we know is that despite the increases to the limit since 2002 when the first regulations came out, the percent of prescriptions for buprenorphine that are diverted has been relatively flat over time.   So while the limit appears to have allowed limited diversion, it also appears to have held back progress toward another goal—improved access to treatment. 

Some addiction specialist physicians have long waitlists for patients seeking buprenorphine treatment, patients living in rural areas cannot find physicians with open treatment slots and primary care physicians typically don’t have the bandwidth to take on this practice full-time.  Increasing the buprenorphine patient prescribing limit will improve treatment capacity, particularly among the most qualified and invested prescribers. 

The Notice of Proposed Rulemaking (NPRM) would increase the highest prescribing limit to 200 patients per physician and at the same time, the proposed regulation that we are publishing today has strong protections to make sure the medications are not diverted.

Why 200? 

When DATA 2000 was enacted, there were no clinical guidelines to inform what good MAT clinical practice should look like.  Today, 14 years after DATA 2000 was implemented, we have nationally-recognized clinical guidelines on the use of buprenorphine for the treatment of opioid use disorder and 14 years of feedback regarding patient experience, clinical practice, and drug diversion. 

We know, for example, that good clinical MAT practice includes medication monitoring, behavioral therapy, diversion control plans and care coordination.  We also know that successful buprenorphine practices include administrative and billing support, advanced clinical practice providers, or established referral networks in order to deliver the highest quality care.  And, we know what bad clinical practice looks like: little physician or patient accountability, poor care coordination and poor patient outcomes.  We think a physician working full time to treat people with opioid use disorder can responsibly treat a caseload of 200 patients.

The proposed regulation doubles the patient prescribing limit while also reinforcing the delivery of safe, high quality care through safety-driven eligibility, infrastructure and reporting requirements.  It attempts to balance public health and public safety at a time of immense and urgent need.  It is our hope that we have done so.  We look forward to comments on the proposed regulation and working with all stakeholders to finalize it.  And ultimately, through rigorous evaluation of the final rule’s impact and ongoing engagement with the public, we will know whether or not we have.


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