Amidst a divisive political climate, there’s one issue that every side agrees upon: the urgent need to combat the deadly opioid epidemic.
Last fall, rare bipartisan cooperation resulted in the passage of the SUPPORT Act, a sweeping package of legislation which addresses multiple aspects of this complex crisis, including treatment, recovery and prevention. This political achievement is to be commended. But a fatal oversight in SUPPORT means that more lives will needlessly be lost every day.
Wildfire without water
Imagine a fast-moving wildfire that is decimating a community.
Now picture this scenario: before firefighters can race to put out the flames, they must submit to a lengthy bureaucratic process for permission to use their hoses. Once granted, the approval still comes with a caveat: the firefighters are only allowed to save a small number of homes. After that, they must turn off their hoses and watch the rest of the town go up in flames.
This is the current state we’re in when it comes to medication-assisted treatment (MAT) for opioid addiction.
The overwhelming consensus amongst the medical community is that MAT is an essential tool for combating the chronic relapsing brain disease of opioid addiction. Political and community leaders also agree that widely increasing access to MAT is imperative. Much like firefighters, medication-assisted treatment providers at CleanSlate are highly trained and experienced in implementing the highest quality standards for care set forth by the American Society of Addiction Medicine (ASAM) and other Federal regulatory bodies.
But strict regulations of one of the commonly prescribed opioid addiction medications - buprenorphine - do the opposite, severely limiting access and costing lives. These regulations are the equivalent of removing hoses from the hands of firefighters.
Since 2000, several laws have been passed that build upon the authority of DATA 2000, including the Comprehensive Addiction and Recovery Act of 2016 (CARA) and the SUPPORT Act of 2018. CARA allowed nurse practitioners and physician assistants to prescribe buprenorphine (Suboxone) for opioid addiction, in addition to physicians. SUPPORT authorized three more groups of providers to prescribe buprenorphine and allowed all provider types to prescribe at higher levels, (i.e., to more patients), if they work in “qualified practice settings” (as defined by Substance Abuse and Mental Health Administration regulations issued in 2016).
Recently, these SUPPORT Act provisions have been partially implemented to provide some relief when it comes to increasing number of prescriptions an eligible provider can write. However, this provides only a small relief valve on the ever-increasing pressure cooker of need for quality addiction treatment created by the opioid epidemic.
An added crisis in a state of emergency
How do these laws and regulations play out in the real world? Last year, one of Indiana’s largest Medicaid providers was faced with a crisis: one of its Indianapolis providers of MAT for opioid addiction had temporarily lost its ability to treat Medicaid patients. Perhaps the suspension was due to an issue with paperwork and filing deadlines, maybe for another reason.
But the consequence of this glitch became a life or death matter for the provider’s 300 patients who were in treatment for the lethal disease of opioid use disorder (OUD). Federal regulators ordered the provider to immediately stop treating all of its patients until the credentialing issue was resolved.
The Indiana Medicaid provider contacted CleanSlate Centers to ask for help. With two MAT centers in Indianapolis, and two additional centers in nearby areas, could we step in and urgently add 300 extra patients to our roster?
(Pictured: Indiana's "Drug Czar," Jim McLelland, at the opening of one of CleanSlate's centers in Indianapolis.)
Our Indianapolis-area staff was eager to spring into action and provide buprenorphine or naltrexone (Vivitrol) to patients needing treatment. But due to the federal restrictions on the amount of buprenorphine a provider can prescribe, we were stymied in our effort to react as quickly as the emergency required.
CleanSlate had to petition the government for two weeks to grant our physicians the emergency waiver that would allow us to treat hundreds of patients who had nowhere to go. These are people whose lives were endangered by abruptly stopping medical treatment for their disease.
Finally, CleanSlate received a waiver and rushed in to treat more than 100 patients, before the original provider regained its credentialing the following week and resumed normal treatment schedules again. The maddening hoops we had to jump through again begged a question that baffles us daily:
Why is the government making addiction treatment so restrictive for qualified providers and organizations who play by all the rules?
Regulations are costing lives, not saving them
Supporters of treatment limits claim that these steps prevent “pill mills” and diversion. But many medications get diverted and split without this kind of legislative reaction. Mysteriously, we are tying our hands about just these specific medications at a time when the country desperately needs to treat as many people as possible, as quickly as possible.
Concerns about diversion overlook the fact that patients are not diverting this medication to get “high.” Anecdotal research has shown that when this medication is diverted it typically goes to people who simply want to avoid the sickness of withdrawal. And the relatively small amount of addiction medications that are diverted pale in comparison to the superhighway of illicit opioids flooding the black market, killing tens of thousands of people every year.
While the diversion of opioid addiction medication must be carefully monitored in order to curb misuse, the larger issue remains lack of availability to high quality addiction medicine provided by skilled providers who can prescribe these medications. CleanSlate is expanding rapidly throughout the country to fill the gap in MAT services, but the frustrating shortage of providers poses challenges to properly and quickly staffing our centers. The arbitrary limits of patients that these providers can treat further hampers our ability to meet the full scope of need that we encounter in every community. Turning away patients who are desperate for help and who may die while waiting for treatment is something that no health care provider should ever have to face.
(Pictured: CleanSlate patients document their progress.)
Stigma hampers treatment of the disease of addiction
The stigma of addiction has created different rules for how we treat this disease. Pain management physicians are allowed to treat patients with buprenorphine as needed; only when this same drug is applied to addiction is there federal oversight. Other disease specialties don’t involve such extreme treatment limitations and enforcement by the Drug Enforcement Agency and other government agencies, which only further ostracizes a disease that is already broadly viewed with suspicion as a moral failure. No wonder so many physicians reject addiction medicine as a specialty.
What happened in Indiana points to the fragility of the medical treatment ecosystem for opioid addiction. We can’t solve the opioid crisis if we make it exceedingly difficult for providers to do their work and for patients to find providers who can treat them. Policymakers regularly beseech providers to adopt the successful practice of addiction medicine. Now we must implore policymakers to remove the regulatory barriers that drive providers away from this practice.
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