When Zac Talbott started methadone treatment for his opioid addiction, he had to travel two hours each direction every day, seven days a week, to pick up his medication from a clinic.
Most patients taking life-saving medications for opioid use disorder (MOUD) face similar hurdles. Indeed, regulatory obstacles — many of which are set by states and vary wildly — can to drop out of treatment or avoid it entirely. Since ongoing MOUD with either methadone or buprenorphine is the only treatment proven to cut the death rate from opioid addiction by 50% or more, these barriers can be fatal.
In December the Center for Public Health Law Research at Temple University Beasley School of Law launched two new databases to help researchers, legislators, policymakers, and patients navigate the rules and restrictions governing how they can receive their treatment. The first database allows users to discover the licensing rules that apply to medication treatment programs in each state, so that they can be compared and analyzed. The other reveals relevant state regulations related to insurance coverage and Medicaid.
Reduction in opioid addiction death rate with the use of MOUDs like methadone or buprenorphine
The hope is that illustrating just how many different restrictions states place on these life-saving medications will inspire a rethink of our inefficient, patchwork system.
“Although methadone and buprenorphine are the gold standard treatment for opioid use disorder, they are not used widely enough,” says Lindsay Cloud, director of the policy surveillance program at the Center for Public Health Law Research at Temple University Beasley School of Law. Cloud’s center hosts the project, which was supported by Arnold Ventures. She explains the group wanted to create these databases because licensing and insurance coverage are among the biggest barriers to care.
“We want to understand, ‘Are the laws actually working? Are the laws having good, bad, or unintended effects on health outcomes?’” says Cloud. “So, one of our primary audiences is researchers, who will use legal data and compare it with health outcome data and run a legal evaluation.”
At the federal level alone, methadone used for addiction treatment is the most regulated drug in the United States. It cannot be prescribed by general practitioners to treat addiction, and federal law has strict oversight over the clinics that are allowed to use it. The regulations specify in great detail the precise requirements for compliance with medication storage, counseling, urine testing and staffing, which can be enforced by visits from the Drug Enforcement Administration. On top of this, most states impose further restrictions — typically adding more requirements related to locations, urine testing, daily pickups, and counseling.
When buprenorphine was approved as an additional treatment option in 2002, regulators deliberately avoided recreating the legal framework applied to methadone, which is widely recognized as too restrictive. Unlike methadone, buprenorphine can be prescribed by general practitioners who are specially licensed to administer the medication, and obtained at ordinary pharmacies.
The level of control the government exerts over MOUD extends to this type of micromanaging of individual cases — and it causes many to avoid the most effective treatment we have for opioid addiction. “It is the states that so often make treatment punitive,” says Talbott, adding that a single resource for understanding the state laws will be useful.
Dr. Ayana Jordan, associate residency director for the psychiatry program at Yale, says the database will likely be more helpful to researchers, rather than patients or clinicians. As a methadone prescriber herself, she already knows how onerous the regulatory net is. One positive impact of COVID — which has otherwise tragically exacerbated opioid overdoses — is that it has led to the relaxation of rules governing medication. Jordan is studying the impact of COVID-related rule relaxation: So far, she says, although the data is limited, the results seem promising. People are not misusing or selling their take-home medication, and are grateful for the increased freedom.
Temple University researchers have already used the databases to uncover some disturbing facts. For example, while all 50 states require their Medicaid programs to cover at least one type of medication, only eight jurisdictions require that commercial insurers do so, further limiting access to medication treatment that must be individualized to meet people’s needs.
Moreover, few states bar insurers from requiring “prior authorization” before medication treatment is allowed, a practice that can lead to weeks of delays in getting care, which can be deadly. One study found that banning prior authorization increased the number of people starting on buprenorphine by 18 percent and also reduced emergency room visits related to addiction.
The databases help by charting the (slow) progress on the issue. Joshua Waimberg, the lead researcher on the project, noted that in 2017, only two states banned prior authorization, while in 2020, the databases show the number has bumped up to 10.
Researchers have found incredible levels of complexity in state regulations, which make it difficult for clinicians and patients to know what’s allowed. Some patients report being told by counselors about regulations banning practices that would make their lives easier — practices that are in reality legal. For example, one New York woman (who asked to remain anonymous) was told this summer that, after weeks of getting monthly take-home doses due to the pandemic, she would have to return to attending the clinic three times a week because the state once again required it. Her commute on public transportation takes over an hour round trip. The truth was, however, that state regulations didn’t change.
Recent figures show an 18 percent increase in deaths compared to last year — due to the impact of the COVID pandemic — despite the fact that we have medications that evidence shows can cut opioid fatalities in half. Researchers are hopeful that shining a light on the many legal and health system obstacles preventing patients from receiving these medications can help dispel misinformation, support repeals of harmful regulations, and save lives.