Elinore McCance-Katz, MD, PhD, is the first assistant secretary for mental health and substance use and leads the Substance Abuse and Mental Health Services Administration (SAMHSA).
Q: In 2017, you were nominated as the first Assistant Secretary for Mental Health and Substance Use and now lead the Substance Abuse and Mental Health Services Administration (SAMHSA). What was the significance of the creation of this role, and what do you see as your primary charge?
The creation of the position of Assistant Secretary for Mental Health and Substance Use in the 21st Century Cures Act was an action by Congress to elevate the importance of mental and substance use disorders and their adverse effects on Americans, their families, and communities. The Substance Abuse and Mental Health Services Administration (SAMHSA) is the only federal agency whose mission is to reduce the impact of mental illness and substance misuse on American communities and my primary responsibility is to lead this agency.
The work of SAMHSA focuses on substance use issues and we are the lead for the federal government in addressing prevention, treatment, and recovery services for the opioids crisis. SAMHSA focuses on addressing the care and treatment and recovery needs of those living with serious mental illness including schizophrenia, bipolar disorder, and major depression. The agency addresses substance abuse prevention interventions that focus on youth and adult needs. SAMHSA also conducts national surveillance that includes analysis of the prevalence of substance use disorders and mental illness in Americans and collects data on the toxicities seen in emergency departments as a result of alcohol and illicit substance use.
In addition, SAMHSA conducts evaluation of the impact of its grant programs to determine if the programs are successfully serving the purpose intended. The agency is invested in providing training and technical assistance to healthcare providers across the nation. As a physician who has spent much of my career training other doctors and healthcare professionals, I know the importance of having a workforce that is prepared to screen for and provide needed services for mental and substance use disorders. This is a means of increasing parity for those living with these conditions by increasing access to care through the training of providers who then can provide those services. All of these efforts are important components of the role of the Assistant Secretary for Mental Health and Substance Use.
Q: One of the federal efforts to combat the opioid epidemic you have been particularly involved in is boosting patient access to buprenorphine, a key drug used in medication-assisted treatment (MAT). Can you explain the importance of increasing patient access to MAT?
Opioid use disorders (OUD) are severe illnesses—tens of thousands die every year of drug overdoses and about 2 million people have an opioid use disorder that requires treatment and recovery supports. Medications that are FDA approved to treat OUD are an important part of a person’s recovery. The medications for OUD that are long-acting opioids (very different from the short-acting opioids that people misuse) block withdrawal. All three of the FDA-approved medications for OUD including the opioid antagonist medication, injectable naltrexone, reduce craving. When these aspects of opioid addiction are addressed, individuals living with OUD can work toward their recovery and addressing those parts of their lives that have been negatively impacted by opioids. Recovery from OUD requires both medication to help to stabilize the physiological and psychological aspects of opioid addiction as well as the opportunity to participate in drug counseling, to gain education about substances and their impact on the person, to learn coping mechanisms to reduce the risk of relapse, and access to recovery support to help a person to get their lives back on track. Medication is also key to interrupting the cycle of drug use, which can also include high-risk injection practices including injection drug use (IDU) that places a person at risk for life-threatening infections such as HIV and viral hepatitis.
Q: The Office of the Inspector General’s recent report, Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder, examined the number of providers who have obtained waivers through the SAMHSA’s Buprenorphine Waiver Program. Can you describe the purpose of this waiver program?
When Congress passed the Drug Abuse Treatment Act of 2000 (DATA 2000) a requirement was put in place to make sure that physicians (and later other providers—advance practice nurses and physician assistants) learned about the treatment of OUD and, specifically, about the pharmacology of buprenorphine to help to assure safe and effective treatment of OUD. At that time, an opioid had never been used in the treatment of OUD outside of specialized and strictly regulated opioid treatment programs, however, buprenorphine was going to be used in both substance use disorder treatment programs and other office-based practice settings including primary care settings. There are no requirements in healthcare practitioner education programs to train on substance use disorders or OUDs despite the high prevalence of these conditions in the United States. When practitioners lack an understanding of the principles of the treatment of OUD, patients may not get safe, effective, evidence-based care, which can lead to poor clinical outcomes. Following completion of required training, practitioners are required to submit a waiver application that must be reviewed and approved by SAMHSA and the Drug Enforcement Administration (DEA) to administer buprenorphine to their patients for OUD from their office-based clinical practice setting. Requiring the DATA waiver was a means of improving the quality of care for OUD.
Q: The same OIG report shows the program has demonstrated success, but it suggests that geographic disparities may still limit access to buprenorphine. Why do these disparities exist and what areas are most impacted?
The same disparities that exist for all medical services in rural areas and other underserved areas also exist for the treatment of OUD with buprenorphine. In addition to the difficulty of adequate numbers of practitioners to serve in rural and impoverished areas in general, the lack of education and experience in treating substance use disorders by healthcare practitioners contributes to a lack of confidence in providing this care for many providers.
Q: Can you share with our readers some of the steps that SAMHSA is taking to increase the availability of buprenorphine and other forms of MAT in underserved areas of the country?
SAMHSA has been working hard to expand the number of providers that obtain the DATA waiver. We have increased funding to the Providers Clinical Support System for Medication Assisted Treatment (PCSS MAT) which provides most of the DATA waiver trainings at this point. Clinicians can get the training at no cost and get free continuing medical education credit for the training and for participation in other online resources that train on relevant topics—for example, use of injectable naltrexone and the use of methadone in the treatment of OUD. SAMHSA has acted to implement the new aspects of the SUPPORT Act, which increased the number of patients that can be treated by a DATA-waived clinician with buprenorphine and increased the types of practitioners eligible for obtaining the waiver. We know that well over 82,000 practitioners from all over the nation now have the DATA waiver and could provide treatment that serves those with OUD using buprenorphine products.
Congress has substantially increased the number of patients that a practitioner can treat with buprenorphine—every eligible provider who completes the DATA waiver can now start treating up to 100 patients and can apply to go to 275 patients after one year of practice in a qualified setting. SAMHSA acted rapidly to upgrade its systems to accommodate these new aspects of the office-based treatment of OUD. What we need is for practitioners with the DATA waiver to practice—to evaluate patients with OUD, prescribe buprenorphine where appropriate, provide counseling, therapy, and recovery services—or refer to those resources. It’s easy to calculate — if all practitioners with the DATA waiver practiced at 100 patients, and there are thousands eligible to practice at 275, we would have the capacity to treat over 8.2 million patients with OUD. It is also worth noting that the federal government has encouraged the use of telehealth and telemedicine as a means of getting more medical resources to these areas and SAMHSA continues to provide technical assistance and training for those willing to provide these services.
Q: Recently, HepVu released data showing state-level estimates of people living with Hepatitis C across the U.S. that highlight a concentration of infections in some states most impacted by the opioid epidemic. States especially impacted include Kentucky, West Virginia, and Tennessee. How important is it to improve access to MAT in areas like this that are at increased risk?
The importance of providing pharmacotherapy for OUD cannot be emphasized enough. OUD, like all substance use disorders, is a chronic illness with substantial relapse potential if a person does not get appropriate care. Kentucky, West Virginia, and Tennessee have major issues with OUD because these are states where many are employed in jobs with high rates of injuries—for example, the mining industry—and often injuries are treated with opioids. This contributes to risk for the development of dependence and addiction. With the understanding of the role of opioid analgesics in the development of OUD, clinicians may be reluctant to prescribe and law enforcement has ended many pill mill situations. This situation contributes to a switch from opioid analgesics to heroin and increasingly fentanyl and other very potent opioid analogs—highly addictive and often deadly. These drugs are often injected using high-risk practices that make the transmission of Hepatitis C much more likely. OUD medications reduce or eliminate cravings thereby reducing the need to inject drugs. Since HCV is transmitted as a result of drug injection practices, treating OUD also helps to prevent the transmission and acquisition of Hepatitis B and C and HIV.
Q: Data from the Centers for Disease Control and Prevention (CDC) shows the largest increase in new Hepatitis C infections is among individuals under 40 years old, particularly due to injection drug use. Can you speak to the connection between the opioid epidemic and the increasing rates of viral hepatitis and HIV?
As mentioned above, there is a strong link between the opioid epidemic and risk for viral hepatitis and HIV infection. A major means of transmitting these infections is related to contact with infected blood. When people share injection equipment, as can often happen as injection is for many the preferred means of opioid use, then if a person has infection with viral hepatitis or HIV they will be quite likely to transmit these infections to others. It is critically important to educate the public about these risks, provide education on substance abuse prevention—for opioids and all substances because we know that polysubstance use is the rule and not the exception.
It is important to make sterile syringe exchange resources widely available because we know that this is an evidence-based practice that reduces the risk for HIV and viral hepatitis infection. It is also very important to train individuals on the identification of opioid overdose and make naloxone widely available to save lives in an overdose situation. For those who develop OUD, it is essential that we make access to evidence-based treatment including FDA-approved pharmacotherapies for OUD as easy as possible. It is also key to include our colleagues in recovery with lived experience in our communities who can assist those struggling to recover.
Finally, it should be underscored that addressing these issues requires integrated services—testing for and treatment of viral hepatitis, substance use disorder, mental disorder, and general medical services; all healthcare providers should be prepared to offer these services or at the least screen and appropriately refer. Providers and community recovery services providers need to work together to provide the wrap-around services so necessary to a person’s recovery and rebuilding their life.