At Boulder, we’re fighting for better treatment for patients with substance use disorders (SUDs) on many fronts. In my role as General Counsel, I’m primarily focused on making sure we deliver care in compliance with federal and state laws and regulations. Unfortunately, that often puts in sharp relief how those laws and regulations not only don’t help people with SUDs, but often inhibit treatment access and quality. Policymakers — from local mayors and health departments to the President and U.S. Congress members — are increasingly advocating for quality health care. But for this to work, ongoing harm from existing laws and regulations must be quickly eliminated.
Many state legislators and professional boards may not even be aware of the harmful impact the laws they write have on actual people and their families. They may have good intentions, but in practice, their regulations have severe unintended consequences that are costing lives at an alarming rate.
Here’s my take on how certain state and federal laws affect patients with SUDs, especially Opioid Use Disorder (OUD), a quarter century into this ongoing crisis.
Over the past two years, the U.S. has faced the catastrophic combination of the COVID pandemic and the escalating opioid epidemic. In 2020 alone, drug overdose deaths rose to 90,000 — representing a ~30% increase in the largest-ever, “historic” and “unheard-of” annual rise in potentially preventable deaths. 70% of those deaths are attributable to opioids.
This is not a new trend. As reported by the New York Times, among others, yearly drug overdose deaths had already surpassed the peak annual deaths from car crashes and gun violence by 2016. Each one of these deaths not only means the end of one person’s life, it also irrevocably changes and damages their family and their community.
Each death also represents a failure of state and federal drug policies. Many of these policies encode into our laws and regulations pervasive and stigmatizing attitudes towards those with substance use disorder.
Limiting Access to Treatment
Despite the fact that medication for opioid use disorder (MOUD) is the gold standard treatment for opioid use disorder, only 18% of people with OUD receive any of the available medications. Many traditional treatment facilities — residential outpatient and inpatient — do not even offer it. Why? The limited use of MOUD (particularly methadone or buprenorphine which are known as opioid antagonists) is due, at least in part, to federal and state limitations on prescribing this life-saving treatment. Methadone can only be dispensed in-person from a federally-certified Opioid Treatment Program, and doctors must get a special waiver to prescribe buprenorphine, and even with that waiver, are only allowed to prescribe to a limited number of patients. We’re in the middle of a crisis where people need medication, but policy is focused on limiting and controlling the distribution of that medication, rather than on helping people get treatment.
These restrictions can make it harder to obtain treatment for OUD than to obtain opioids. This doesn’t exist for any other medical condition. But there is a fear inherent in these policies that a small number of people will misuse the medication, and that that is somehow more pressing than getting the vast majority of people access to the care they need.
The truth is, laws focused on restricting access often reflect a morality judgment and systemic bias against patients with OUD, deeming them to be “untrustworthy people” and therefore undeserving of proper, standard medical attention.
Conditional Treatment = Conditional Support
Even for patients who can find access to MOUD treatment there are additional policy hurdles and barriers to climb, which do a disservice to both patient and provider. Many state legislatures, as well as medical, nursing and pharmacy licensing boards, place onerous conditions on methadone and buprenorphine. But making treatment something someone can only have IF they follow such strict conditions means that fewer people can get treated. The conditions also limit clinicians’ professional judgment and further stigmatize patients who already experience too much callous suspicion in other aspects of their lives. These include:
Mandatory and/or random drug screens
In order to begin MOUD treatment, patients are frequently required to submit to drug screenings which act like purity tests, to decide if a patient is “clean” and therefore deserves to be helped/saved. But this is assigning a moral value to a chronic disease, and doesn’t serve the patients. These tests also often involve dehumanizing testing conditions and treat patients as inherently untrustworthy and unreliable participants in their own medical care. And once treatment is under way, patients who “fail” these tests are often kicked out of their treatment program (see below re: abstinence) despite the fact that their use is based on “little evidence on the effectiveness of [drug screens] on patient or community health outcomes.” (International Journal of Drug Policy)
Required participation in 12-step programs or other behavioral or psycho-social counseling
These programs are helpful for some patients, but many have already tried and had unsuccessful or traumatic experiences. Moreover, there is ample evidence that “traditional counseling is not necessary for successful outcomes in buprenorphine treatment.” (Annals of Internal Medicine) Regulating that a patient must attend a program with no scientific basis is not only unfair, it shows that the legislators instituting the requirement have little understanding of the problem at hand. And they are, once again, creating policies based on biases against OUD patients as untrustworthy, who must submit to extensive behavior rules just to prove their dedication to their own recovery before they are deemed worthy of care.
Abstinence from opioids
There is widespread understanding amongst addiction specialists that abstinence is an ineffective and unrealistic requirement for patients with OUD. It’s also unnecessary in order to maintain good outcomes for patients. The evidence shows that “over the long term, stable complete abstinence from opioid use is low . . . . [i]terative relapse is the most common path, an expectation to be managed and addressed, and an indication to refine problem-solving strategies and care.” (Annals of Internal Medicine) And strict adherence to any form of long term treatment for a chronic condition tends to be unreliable. The solution for a patient with Type 2 diabetes or high cholesterol not making proper changes to their diet and properly monitoring blood levels is not to deny them a prescription, and the exact same logic should apply to OUD treatment.
Abstinence from other substances
Creating a requirement that a patient seeking treatment from OUD must not be allowed to use any controlled substance seems to be grounded in the myopic view that any substance use impedes treatment for OUD. But studies have shown that it doesn’t. “Patients can succeed with MAT in the presence of other substance use. In a study comparing patients who did and did not use cocaine, those entering buprenorphine treatment who reported concomitant use at baseline (nearly 40%) had similar retention and reduction in opioid use.” (Annals of Internal Medicine) If the evidence shows us that abstinence from other substances doesn’t impact treatment, requiring it is purely about the stigma that policymakers hold for substance users, and not about helping OUD patients.
Prescription dosage and duration limitations
Dosage and duration limitations do not line up with the best medical practices for treating chronic diseases, and can serve to limit the effectiveness of OUD treatment. And now, with the extreme potency of fentanyl doing most of the harm to people with OUD, we should be concentrating on commensurate dosing with methadone and buprenorphine to keep up with the changing nature of the crisis.
These harmful restrictions on prescriptions tend to be driven by fears of diversion, i.e. that patients will sell their medication rather than take it — some states even require documentation of “responsible handling of medication,” which would be a condescending message if it were applied to a teenager, let alone an adult seeking medical treatment. But — especially in the case of Suboxone, one of the most common and effective forms of MOUD — these concerns ignore the social benefit created by making Suboxone more readily available. Diversion may happen, but these situations have been carefully studied and consistently find two outcomes: First, people using Suboxone that is not prescribed to them do so to reduce their use of lethal street opioids like fentanyl. And second, in areas where there is more "diverted" Suboxone, there are fewer overdoses. Suboxone is being used in a rational way, a form of self-treatment by people who otherwise face the risk of harm and death each day.
Limiting prescriber locations and requiring in-person visits
Placing limitations on the number and location of available prescribers, and concurrently requiring that treatment must be in-person, creates physical barriers to treatment most patients can’t overcome. These restrictions also stem from paternalistic and exaggerated fears around the trustworthiness of patients and the role they should play in their own health care.
A troubling and representative example of this institutionalized stigma was included in the Kentucky Medical Board’s recently-published opinion arguing against expanded telemedicine-based MOUD, where they reasoned that:
[B]y the mere act of seeking medication assisted treatment, this patient population has acknowledged a loss of self-control and regulation over controlled substance use. Such patients are not in a position to reliably monitor themselves. Therefore, in an effort to protect these patients and the public, clinical circumstances require direct oversight and supervision of patient compliance during medication assisted treatment.
State and federal laws already dictate whether a patient must go in-person to an opioid treatment program (OTP), a brick-and-mortar rehabilitation facility, or a specially-qualified physician practice, regardless of how (im)plausible it is for most OUD patients to get to one of those providers — including in regions where treatment is largely unavailable. These laws — and the policies and attitudes represented by the Kentucky Medical Board — place unwarranted value on brief physical interactions that can be enormously inconvenient to patients when there is no clinical evidence that starting and continuing buprenorphine is more effective in a medical setting than at home. The two methods are “essentially equivalent” for this process, where a patient begins to take buprenorphine through a sequence of small doses. Boulder Care is currently partnering with the Oregon Health and Science University (OHSU) in a National Institute on Drug Abuse-funded study designed to test patient retention and quality of life outcomes in traditional treatment contexts (i.e. brick-and-mortar) vs. telehealth, and we’ll share more on our findings soon.
Taken together, all of these requirements represent a clinical support model that requires jumping through hoops that range from challenging to impossible. Conditional treatment dehumanizes patients, takes away their personal agency and responsibility, erodes trust, and furthers the harmful stereotypes and stigmas associated with OUD in the very context in which they do the most harm — by preventing patients from accessing treatment in the first place or dissuading them from sticking with it.
The end result is the same: more harm and more deaths.
One Step Forward, One Step Back
At the beginning of the COVID public health emergency (PHE), the DEA waived the in-person visit requirement for MOUD, allowing for telemedicine-based evaluations by qualified providers and at-home inductions. Many states also paused enforcement on their own rules and regulations, in some cases explicitly recognizing the discouraging effect the policies have on patients. For example, Pennsylvania’s temporary waiver of its in-person evaluation requirement reasoned that it “curtails access to buprenorphine provided via telemedicine and, in many instances, creates a potentially insurmountable barrier for individuals who would benefit greatly from buprenorphine treatment.”
But absent any federal congressional action, or the DEA finally implementing a years-overdue telehealth registration process, the federal requirements will be reinstated at the end of the PHE. And the state requirements — including Pennsylvania’s — are already scheduled to resume and will persist regardless of any changes in federal law.
We Must Make it Easier, Not Harder
These policies may have been enacted by well-intentioned legislators and policymakers, but their sum effect is to discourage or prevent people with a disease from seeing a clinician.
If the goal of policymakers and the healthcare community at-large is to reduce the human cost of the opioid epidemic, or to even begin a downward trend in overdoses, eliminating these unnecessary — and actively stigmatizing and harmful — treatment conditions is the first and only place to start.
There has never been a better time to build on the public’s and the medical community’s expanding experience with telehealth, and create policies supporting empathetic, effective health care at locations where the patient feels safest and can actually access lifesaving medication.