Throughout the COVID-19 pandemic, there have been a multitude of regulatory changes and strategies adopted in an effort to provide the American healthcare system with added flexibilities during this public health crisis. With the stress of these uncertain and isolating times, mental health and substance-use disorder (SUD) patients are particularly at risk. In a recent Kaiser Family Foundation poll, 45 percent of Americans are reported to feel that “worry and stress related to coronavirus is affecting their mental health.” In addition, social isolation, economic stress, and unemployment make SUD patients more vulnerable to relapses. Therefore, behavioral healthcare is a key area in which changes have been necessary to respond to this pandemic.
As previously covered by Norton Rose Fulbright attorneys in this Law360 article, the following is a summary of several measures taken in recent weeks at the federal level to facilitate ease of access to behavioral healthcare. Beyond the federal measures, there are still state considerations that providers should keep in mind while responding to the COVID-19 outbreak:
- Medicare. On March 17, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it would temporarily modify the originating sites that are permissible for a Medicare beneficiary to receive telemedicine services by a Section 1135 waiver. Traditionally, under Medicare guidelines, beneficiaries’ homes generally could not be originating sites. For the duration of the COVID-19 public health crisis, and as a result of CMS’s telehealth guidance, all Medicare beneficiaries can receive healthcare, including behavioral health treatment and therapy, in any setting within the United States.
- Telemedicine Prescribing. The U.S. Drug Enforcement Administration created several exceptions to the Ryan Haight Act. These exceptions allow providers, among other things, to issue prescriptions for controlled substances to patients that the provider does not have a pre-existing relationship with through telemedicine during this public health crisis.
- Addiction Treatment. On March 19, the Department of Health and Human Service’s Substance Abuse and Mental Health Administration (SAMHSA) issued a FAQ, entitled Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency. In this FAQ, SAMHSA explains that practitioners working in an Opioid Treatment Program (OTP) can temporarily prescribe buprenorphine for new patients without having to perform an in-person physical evaluation if the provider believes that an adequate evaluation can be conducted utilizing telemedicine. In addition, SAMHSA noted that this exemption “does not apply to new OTP patients that are treated with methadone.”
- Privacy Law Updates. On March 28, HHS’s Office for Civil Rights released a bulletin in which it stated that it “will exercise enforcement discretion and will not impose penalties for HIPAA violations against healthcare providers that in good faith provide telehealth using non-public facing audio or video communication products, such as FaceTime or Skype.” While there was initially some confusion with how Code of Federal Regulations Title 42, Part 2 on SUD records would coincide with these changes, the Coronavirus Aid, Relief, and Economic Security (CARES) Act revised several privacy restrictions to better conform with these HIPAA relaxation measures. The most notable change is that after providers receive prior written consent once from a patient their SUD records can be used or disclosed by a covered entity, business associate, or part 2 program for the purposes of “treatment, payment, and healthcare operations as permitted by the HIPAA regulations.”
- As previously discussed, CMS waived certain telehealth requirements under the Medicare program for the duration of the COVID-19 outbreak. However, CMS neither preempted nor waived any state Medicaid or regulatory requirements that also need to be followed in order for a healthcare provider to practice telemedicine within any given state. While a number of states have made changes to their Medicaid programs and telemedicine regulations during this public health emergency, these changes vary significantly from state to state, and at times, need further clarification. For example, a few states have made changes to their state licensure requirements, allowing out-of-state providers to deliver telemedicine services within their state. However, even in states that allow out-of-state providers to deliver telemedicine services, questions still remain regarding potential medical liability for out-of-state providers, the notice requirements needed to be followed in order for an out-of-state provider to begin providing telemedicine in any given state, and whether out-of-state providers can prescribe controlled substances in the state utilizing telemedicine. To answer these questions, among others, it is important to not only review the current federal regulatory measures but also be mindful of individual states’ regulatory rules and develop state specific strategies.
Norton Rose Fulbright attorneys will continue to monitor relevant behavioral healthcare updates during the COVID-19 outbreak and publish them on the Health Law Pulse.