There is optimism among some leaders that getting rid of the X-waiver, a special Drug Enforcement Administration certification that was required for clinicians to prescribe buprenorphine, will expand access to buprenorphine and reduce overdoses. However, it remains to be seen whether clinicians will now step up prescribing. Many primary care doctors do not have experience managing people with addiction. Some clinicians are apprehensive about using an opioid to treat opioid use disorder, despite evidence it is lifesaving. Although the restrictions on prescribing are no longer in place, the perception created by them lingers (i.e., that it is difficult to treat people with addiction). Clinicians will need education. States should use pharmacists, partnered with doctors, to help manage care of patients. Clinicians should be held accountable for providing addiction care through quality measures tied to payments, and insurers should reimburse clinics for the cost of staff who are not traditional clinicians but critical to care, like recovery coaches and case managers. Removing buprenorphine restrictions has the potential to address racial disparities, but social supports are also needed.
Doctors, public health experts, and even Democratic members of Congress are sounding the alarm on the new Drug Enforcement Administration (DEA) proposal to require an in-person visit for buprenorphine prescriptions beyond 30 days. The DEA said the rule aims to ensure the safety of patients, but opponents say any reduction in buprenorphine access will have the opposite effect. The proposed rule is part of a broader crackdown on doctors who prescribe controlled substances via telehealth. It illustrates that there is little agreement about the risks and benefits of highly effective addiction medications, even within a Democratic administration in which addressing the opioid crisis as a top priority. Some doctors did acknowledge that an in-person follow-up is ideal, but addiction treatment rarely takes place in ideal circumstances. Addiction medicine experts say lack of access to buprenorphine is a bigger threat than buprenorphine diversion. Even if the rule is finalized, however, buprenorphine will remain more accessible than before COVID, when telehealth prescriptions were not allowed and doctors needed a waiver to prescribe.
Senators Paul (R-KY) and Markey (D-MA) introduced the Modernizing Opioid Treatment Access Act, which would improve patients’ ability to access medications for opioid use disorder by modernizing outdated rules, empowering board-certified physicians to prescribe methadone and allowing pharmacies to dispense methadone. The bill would also require an annual report on the number of providers registered to prescribe methadone, patients prescribed methadone and a list of states where physicians are registered to prescribe methadone. Partnership to End Addiction endorsed the legislation. Bipartisan members of Congress also sent a letter to the Department of Health and Human Services expressing their support for regulations that would expand access to medications for opioid use disorder, while highlighting barriers that will continue to face those seeking access to methadone under the rules. They propose allowing addiction specialist physicians outside of opioid treatment programs to prescribe methadone for pick-up at pharmacies.
Source: Dr. Paul, Sen. Markey Introduce Modernizing Opioid Treatment Access Act to Reach More Americans Suffering from Opioid Use Disorder as Annual Overdoses Surpass 100,000 Across U.S. (Rand Paul); To Combat Opioid Epidemic, Sen. Markey Leads Colleagues In Urging HHS To Expand Access To Life-Saving Medication Treatment (Ed Markey)
Even as the Biden administration is removing the waiver requirement to make it easier to prescribe buprenorphine, one of its agencies, the Drug Enforcement Administration (DEA), subjects it to such strict regulation that many are reluctant to dispense it. Doctors report that they have trouble getting buprenorphine prescriptions filled, as pharmacies and distributors try to avoid running afoul of the DEA system tracking suspicious orders of controlled substances. Pharmacies and distributors are anxious about legal jeopardy, following the opioid litigation faced by their industries. The DEA said it supports the new law and wants to see medications accessible to everyone who needs them. It said it is reaching out to pharmacies and making public statements to encourage buprenorphine prescribing and is working to identify bottlenecks in distribution. Practitioners also pointed to obstacles beyond the DEA’s rules. These include doctors still not knowing the waiver requirement is gone; stigma; insurance coverage; and state requirements for buprenorphine prescribing.
Source: Biden’s next battle in his opioids fight: His own bureaucracy (Politico)
Pharmaceutical distributors Cardinal, McKesson and JM Smith Corp prevailed at a trial in Georgia in a case brought by families of people with opioid use disorder accusing the companies of acting as drug dealers. It was the first trial of opioid claims brought by individual plaintiffs rather than government entities. The 21 plaintiffs included children whose parents died of overdoses, a woman whose grandson was born dependent on opioids and died at one month old, and a woman who was raped as a teenager but received no help from her mother, who had opioid use disorder. Plaintiffs said the distributors fueled illegal opioid use by filling illegitimate pharmacy orders and failing to report suspicious orders as required by law. Unlike most other opioid lawsuits that accused the companies of creating a public nuisance, these claims were brought under Georgia’s Drug Dealer Liability Act, which allows people injured by illegal substance use to sue dealers.
Source: Cardinal Health, McKesson prevail in Georgia families’ opioid trial (Reuters)
The New Jersey Department of Health (NJDOH) is launching a new overdose hotspot outreach initiative prioritizing areas of the state with high disparities and high rates of overdose among Black residents. NJDOH analyzed emergency medical services and law enforcement naloxone data to identify locations where overdoses most frequently occur, identifying four key location types – transportation centers, correctional facilities, hotels/motels and apartment complexes. NJDOH identified over 30 locations where there were at least nine suspected overdoses consistently between 2019 and 2022 and is prioritizing locations for outreach where racial disparities in overdose are highest. NJDOH is distributing naloxone, fentanyl test strips, hygiene kits and other resources for individuals at risk for overdose. Health educators and peers will provide engagement opportunities to people at risk of overdose to connect them to harm reduction and treatment. NJDOH is providing hotspot locations with naloxone education and offering naloxone kits for establishments to store for bystander use.
Source: New Jersey Health Department Initiative Targets Overdose Hotspots (NJ Health)
Ohio launched new data dashboards to better track and report data on overdose deaths and other substance use-related measures for all 88 counties. The dashboards were adopted and expanded from dashboards created through the HEALing Communities Study. Through the study, researchers initially developed community-tailored data dashboards that included opioid overdose deaths and other opioid use disorder-related measures for 18 counties. Using the data in the dashboards, communities partnered with researchers to determine which evidence-based interventions to implement to reduce overdoses and opioid misuse. The dashboards have now been expanded statewide. They report on 55 opioid-related measures including overdose deaths, high-risk prescribing, overdoses treated in emergency departments, naloxone units distributed by Project DAWN, individuals receiving treatment and emergency medical services events involving naloxone administration.
Source: Ohio Launches New Data Dashboards to Report Overdose, Substance-Use Measures (Mike DeWine)
Oklahoma voters overwhelmingly rejected a recreational marijuana legalization ballot measure. Over the past five years, Oklahoma has built a booming medical marijuana industry. There are roughly 12,000 licensed medical marijuana businesses in the state, nearly three times as many shops as there are in California, which has roughly 10 times the population. The main reason is that there initially was no limit on how many licenses could be issued, and they cost only $2,500. Roughly 10% of the population is enrolled in the medical program, by far the highest level of participation per capita in the country, as there are no qualifying conditions. The market has sparked a backlash in the conservative state, especially in rural areas inundated with marijuana farms and as a result of recent raids on illegal grow operations. Legalization supporters touted the economic benefits adult use sales would have created, while opponents argued that if the medical market has proven out of control, opening it up to recreational sales would only exacerbate the problems.
Bipartisan bills were reintroduced in Congress that would allow patients to get methadone at local pharmacies. Proponents say methadone has proven to be effective but remains frustratingly difficult to get. The rigid clinic system imposed 50 years ago often requires daily visits that stigmatize patients, disrupt lives and make it difficult to work. Aside from the proposed legislation, the federal government is moving to make permanent the COVID take-home dose flexibilities. AATOD, the industry group representing methadone clinics, opposes proposals to expand access to methadone beyond the clinic system, citing concerns about diversion of methadone and increased overdoses. Those concerns are dismissed by addiction specialists and the bills’ backers, who note that methadone can already be prescribed by physicians and dispensed by pharmacies for pain. A review of peer-reviewed research on the COVID flexibilities found that the changes did not result in increases in overdoses or other adverse effects and potentially improved treatment retention and quality of life.
Source: As drug deaths soar, experts urge expanded access to methadone (The Washington Post)
Congress’s elimination of the buprenorphine waiver requirement dramatically expanded the pool of health workers who could prescribe the medication. However, addiction experts warn the change may not be a panacea. The health system’s gaps in reaching people with addiction remain vast. Medical schools tend not to incorporate addiction in their curriculums, and some health care providers are wary of the psychiatric and social needs of people who use opioids. Even when someone obtains a buprenorphine prescription, some pharmacies may not dispense it. During COVID, the federal government allowed buprenorphine to be prescribed initially via telehealth, but new proposed rules would limit prescribing to 30 days without an in-person appointment. The elimination of the waiver requirement may expand access in primary care settings and for incarcerated people. Resources are needed to reduce stigma and provide training and structure for providers to prescribe buprenorphine.
Source: More Doctors Can Now Prescribe a Key Opioid Treatment. Will It Help? (The New York Times)