By Jocelyn A. Guyer, Managing Director, Manatt Health | Karen Scott, MD, MPH, President, Foundation for Opioid Use Response Efforts (FORE)
Editors’ Note: As COVID-19 rips through the country, an often-overlooked population at extraordinarily high risk is the nearly 2 million adults with opioid use disorder (OUD). This group faces a perfect storm of health and socioeconomic risk factors that make it more likely it will contract the virus and end up hospitalized. Moreover, for those now in recovery or looking to start recovery, the COVID-19 pandemic has generated new barriers to accessing the medications used for opioid use disorder (M-OUD) and the counseling and peer supports that are often critical pieces of the recovery puzzle.
It has become clear, however, that there are specific strategies that the federal government, states and other stakeholders can use to mitigate the impact of COVID-19 on people with OUD. Most important, states can leverage the increased flexibility provided by the federal government in response to the pandemic to help maintain access to M-OUD and increase use of telehealth for counseling and peer support. In a recent post to the Health Affairs blog, summarized below, Manatt examines the pre-COVID-19 regulation of M-OUD treatment, the strategies for mitigating the impact of the pandemic on people with OUD—and what’s next. Click here to read the full post.
Pre-COVID-19 Regulation of M-OUD Treatment
Even prior to the pandemic, it was difficult for people with OUD to gain access to buprenorphine and methadone, the two major medications used for OUD. Researchers estimate that only about one in five individuals with OUD obtain any specialty addiction treatment, and only a subset of these individuals receive M-OUD. This is in part because these medications are tightly regulated by a complex interplay of federal agencies, including the federal Drug Enforcement Administration (DEA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Office of Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS). States also layer their own regulations and procedures on top of the expansive federal requirements.
In normal times, federal regulations limit who can prescribe M-OUD and the circumstances under which they can do so.
- Buprenorphine: Practitioners must obtain a waiver of the Drug Addiction Treatment Act of 2000 to prescribe or dispense buprenorphine. Even then, they generally may only treat up to 100 patients in their first year and must apply to expand that cap to 275 patients per year. Practitioners can initiate medication only after conducting an in-person visit.
- Methadone: Methadone can only be provided by specially credentialed opioid treatment programs (OTPs). Typically, many clients of OTPs must show up in person at a clinic each day to receive their medication, and take-home doses are strictly limited.
During COVID-19, these regulations conflict with social distancing practices, further limiting access to medications. As detailed later in this post, during COVID-19, federal agencies have temporarily eased many restrictions on in-person visits for M-OUD while still maintaining regulations on who can prescribe M-OUD.
Strategies for Mitigating the Impact of COVID-19 on People With OUD
We review here some of the policy options available to states for adapting OUD treatment to the pandemic. (The best ways for frontline providers to provide care and support for those with OUD through the pandemic are discussed in depth in this recent webinar by the Foundation for Opioid Response Efforts (FORE).)
Cover All Forms of M-OUD Without Prior Authorization in Medicaid
The first thing states can do is review their existing policies on access to medication for OUD in Medicaid. Many states already have taken a hard look at these policies to ensure they include all forms of M-OUD on their Medicaid drug formularies and have eliminated all prior authorization requirements. For states that have not reviewed these policies recently, it is critical to do so now. In the current pandemic, barriers to access take on an outsize importance, limiting options for connecting people to critical medications.
Eliminate or Suspend Counseling Requirements That Limit Access to Medication
While the gold standard for treatment remains a combination of medication and counseling, on March 18, 2020, the American Society for Addiction Medicine (ASAM) issued updated practice guidelines for OUD that highlight that a patient’s inability or decision not to participate in counseling “should not preclude or delay pharmacological treatment of opioid use disorder.” Because it is particularly difficult to participate in counseling during the pandemic, states such as West Virginia are temporarily suspending any requirement that people participate in counseling as a condition of receiving M-OUD.
Exercise the State Option to Allow Extended Take-Home Supply of Methadone
Reversing a decision from just a few weeks ago, SAMHSA now is allowing states to decide whether OTPs can provide established patients with a 28-day take-home supply of methadone if they are stable, and with a 14-day supply if they are less stable but able to safely handle take-home doses of methadone as clinically appropriate. States, however, need to request the blanket exception from SAMHSA to enable these flexibilities and then alert providers to the change, as states such as Massachusetts and New Jersey have done. Additionally, OTPs can arrange for alternative delivery of methadone in the event a patient is quarantined due to COVID-19.
Shift OUD Treatment to Virtual Settings
Over recent weeks, the country has moved blindingly fast to transform the regulatory environment for telehealth, mostly on a temporary basis during this public health emergency. Medicare has opened up use of telehealth for new (not just established) patients and shed limitations designed to limit telehealth to rural areas and providers in certain settings. OCR, which oversees the Health Insurance Portability and Accountability Act (HIPAA), also has jumped in, using its enforcement discretion to clear the way for providers to use products such as Apple’s FaceTime, Google Hangouts video, Zoom and Skype without fear of violating HIPAA.
States have their own key role to play, both in allowing use of telehealth under any state licensing requirements and in opening up Medicaid to reimburse for such care provided via telehealth. For those with OUD, the most important state telehealth options include:
- Exercising the state option to allow initiation of buprenorphine without an in-person visit
- Using Medicaid to support virtual counseling and peer support through telehealth
- Ensuring that “telehealth” extends to phone calls
Next Steps
Through the unprecedented response to the pandemic, the federal government and states are working to offer new avenues for maintaining treatment and supporting individuals with OUD. In the days and weeks ahead, it will be critical for more states to dedicate attention and resources to the needs of this vulnerable population. In the longer term, as the COVID-19 crisis eases, it also will be important to evaluate whether any of the temporary policy changes should be adopted on an ongoing basis.