On July 7, 2021, the U.S. Department of Health and Human Services (“HHS”) Secretary Xavier Becerra renewed the COVID-19 public health emergency declaration (the “COVID-19 Emergency Declaration”).
It is expected that the COVID-19 Emergency Declaration will be renewed throughout 2021. HHS also renewed another public health emergency declaration on July 7, 2021, that most likely did not gain the same attention as the renewal of the COVID-19 Emergency Declaration. Specifically, HHS also renewed yet again its October 26, 2017, determination that the national opioid crisis continues to be a public health emergency. Almost four (4) years after the initial opioid crisis public health emergency determination, the country is still addressing the national opioid crisis that was intensified by the COVID-19 pandemic.
Based on preliminary data from the National Center for Health Statistics of the Centers for Disease Control and Prevention (“CDC”), in 2020 the number of drug overdose deaths reached their highest point recorded since January 2015. Additionally, many states had drug overdose deaths increase more than thirty percent (30%) when compared to drug overdose deaths in 2019.
Not only is the opioid crisis and other substance use disorders becoming a more prevalent issue, but the general mental healthcare needs of adults have become more worrisome. Adults surveyed in late June 2020 reported symptoms of anxiety or depression, starting or increasing substance use, stress-related symptoms, and serious thoughts of suicide at rates nearly double that which researchers would expect prior to the COVID-19 pandemic.
Also the demand of urgent mental healthcare for children has risen at a troubling rate. For example, from March 2020 through October 2020, children’s visits to emergency rooms for mental health treatment rose thirty-one percent (31%) for children that were twelve (12) to seventeen (17) years old and twenty-four percent (24%) for children ages five (5) through eleven (11) in comparison to March 2019 through October 2019.
Eventually, the HHS COVID-19 Emergency Declaration will expire along with the regulatory flexibility that came with the Declaration, but the significant mental healthcare needs that either resulted from the COVID-19 pandemic or were further exacerbated by the COVID-19 pandemic will remain and will become one of the forefront health concerns moving forward. Furthermore, many states, even though those that arguably were hit the hardest by the COVID-19 pandemic, have already lifted their emergency orders. The expiration of the state emergency orders resulted in the termination of waivers and exemptions from strict telehealth requirements for mental health services and prescribing and dispensing controlled substances medication set in place before the COVID-19 pandemic.
So what now? How do we eventually move forward from the COVID-19 pandemic while also addressing significant mental healthcare needs? The Biden-Harris administration campaigned on a plan to end the opioid crisis and to further address delivery and access to mental healthcare. We already are seeing that plan in action and based on Biden-Harris’s spring 2021 regulatory agenda further flexibilities to ensure we address mental health needs will be forthcoming. Additionally, states are also taking action into their own hands and taking the lessons they learned during the COVID-19 pandemic to address mental health, including for children, at the state level. These steps to mitigate the significant unmet mental health needs by federal and state government are further discussed below.
Increasing Flexibility for Buprenorphine Prescribing and MAT
On April 28, 2021, HHS released practice guidelines for the administration of buprenorphine for treating opioid use disorders (“OUD”). The new guidelines exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from certification requirements related to completion of training regarding opioid maintenance and detoxification and being able to provide counseling and other services (such as psychosocial services) to patients in order to obtain a waiver to treat up to thirty (30) patients with buprenorphine. These certification requirements were seen as a barrier to treating more individuals and HHS determined that these guidelines will assist in providing more accessible medication-based treatment for OUD.
Effective July 28, 2021, the United States Department of Justice Drug Enforcement Administration (“DEA”) eased rules for mobile vans to dispense methadone throughout a state where a opioid treatment program (“OTP”) is located. Specifically, the DEA eliminated the requirement that OTPs have to obtain a separate DEA registration for their mobile vans to dispense methadone. The hope is that these mobile vans can expand access to maintenance or detoxification treatment to rural and other medically underserved areas. Previously, the DEA only authorized mobile treatment vans of OTPs to dispense methadone on an ad hoc basis and had placed a moratorium on any further authorizations in 2007.
The Biden-Harris’s spring 2021 regulatory agenda also proposes to finally address the special registration process to prescribe controlled substances by the practice of telemedicine that was introduced in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”). The Ryan Haight Act prohibits the prescription of controlled substances via telemedicine to patients in their home unless an in-person medical evaluation has been completed or the prescriber is able to meet a narrow exception. One of these exceptions was the “special registration” exception whereby the DEA would implement rules to permit prescribers to prescribe controlled substances through telemedicine to patients in their homes and other locations. The Special Registration for Telemedicine Act of 2018 also sought to require the DEA establish rules to deliver, dispense, or prescribe controlled substances via telehealth by October 2019, but the DEA did not meet this deadline. It is the expectation that such proposed rules will permit more prescribers to in part prescribe necessary controlled substances to patients with mental health needs.
As part of the Biden-Harris administration’s drug policy priorities, the administration is also focusing on further promoting harm reduction services. Harm reduction services include services such as administration of naloxone to reverse the effects of overdose within the community and syringe services programs (“SSPs”). The administration cites that harm-reduction organization can be critical as a first point of contact for those that need care and provide low-barrier services. The administration’s plan is in part to explore opportunities to lift barriers to federal funding to SSPs and identify states laws that limit access to harm reduction services. The American Rescue Plan Act of 2021 also included $30 million to fund harm reduction services.
At the state level, Rhode Island recently became the first state to permit harm reduction centers whereby people may take illegal drugs under the supervision of medical professionals. The two (2)-year pilot program will take effect on March 1, 2022. Along with the pilot program, there will be an advisory committee that will analyze the recovery of persons utilizing such harm reduction centers and the effects federal, state, and local laws have on the operations of such centers.
Expanding Telehealth Reimbursement for Mental Health Services
On July 23, 2021, the HHS Centers for Medicare and Medicaid Services (“CMS”) released its annual Physician Fee Schedule proposed rule (the “Physician Fee Schedule Proposed Rule”). A major focus of the proposed rule is “expanding access to behavioral healthcare and reducing barriers to treatment.” CMS is proposing to implement telehealth reimbursement changes for individuals with a mental health disorder pursuant to the Consolidated Appropriations Act of 2021. Such reimbursement changes would permit patients anywhere, including the patient’s home, to access telehealth services for diagnosis, evaluation, and treatment of mental health disorders so long as certain conditions are met. To further expand access, CMS is also proposing for the first time to permit Medicare to pay for telehealth mental health visits provided by federally qualified health centers and rural health clinics in order to promote access to care for rural and vulnerable populations.
During the COVID-19 pandemic, CMS temporarily waived its requirement that telehealth services be through interactive communications systems and permitted Medicare payment for certain behavioral health services that were audio-only evaluation and management (E/M) visits. Acknowledging that such waiver authority will no longer exist after the COVID-19 Emergency Declaration expires and that there remains a continual shortage of mental health care professionals, CMS determined that Medicare beneficiaries have relied on audio-only telehealth to receive behavioral health services and removal of payment for such services would negatively affect the access to behavioral health care for these individuals. Therefore, CMS proposes in the Physician Fee Schedule Proposed Rule to permit audio-only communication technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders at a patient’s home when certain conditions are met. Notably, this also includes counseling and therapy services provided through OTPs.
States also have acknowledged the ability to increase access to care by requirement reimbursement for audio-only telehealth services. For example, Nebraska’s Governor on April 21, 2021, approved legislation that provides telehealth now includes audio-only services for the delivery of behavioral health services for an established patient when appropriate or for crisis management and intervention for an established patient. Such inclusion prohibits private insurers from arguing that audio-only behavioral health services are not telehealth services and therefore not required to be reimbursed. The legislation also required Nebraska’s Medicaid program to also reimburse audio-only behavioral health services.
Increasing Children’s Access to Mental Healthcare
With the opioid epidemic still at the forefront, it is possible that the mental health needs of children were overshadowed. The COVID-19 pandemic has brought to light the significant unmet mental health needs of children and the federal and state government are working together to determine optimal ways to address these needs. In the last month, the United States Department of Education (“DOE”) has approved states’ plans to use American Rescue Plan funds to address, in part, mental health needs of students. Ohio, for example, plans to use a portion of its American Rescue Plan Elementary and Secondary School Emergency Relief funds to have the Ohio Department of Education collaborate with the Ohio Governor’s Office, the Ohio Department of Medicaid, and the Ohio Mental Health and Additional Services to further expand school mental health services and to increase behavioral health supports for students. The Governor of Illinois also recently signed into law a bill for the state’s Children’s Mental Health Partnership to establish recommendations to ensure that all Illinois children are able to receive mental health care at school.
It is expected that the flexibility in delivery of mental healthcare seen during the COVID-19 pandemic will be promoted to become permanent as is currently being proposed by some federal agencies and at the state level. Furthermore, nontraditional ways to address mental health needs, such as SSPs, may perhaps initiate acceptance at the federal level to be tested by various states. Arguably there has never been a time where mental health needs of adults and children has received so much attention at federal and state government level. It is hoped this much-needed awareness will improve mental health care delivery and outcomes throughout the country.
Written by Jena Grady, an associate in Nixon Peabody’s Health Care practice group, view bio here.