The calls for utilizing telemedicine in battling the opioid crises in the U.S. are growing louder. On January 30, 2018, Senators Claire McCaskill (D-Mo.), Lisa Murkowski (R-Alaska), and Dan Sullivan (R-Alaska), sent a letter to Robert W. Patterson, the Acting Administrator of the U.S. Drug Enforcement Administration (DEA), urging the agency to promulgate regulations that would allow healthcare providers to prescribe medication-assisted treatments via telemedicine for persons with opioid dependence disorder.

The letter specifically addresses the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. 802(54)) (the “Act”) as the primary stumbling block preventing physicians from prescribing medication-assisted treatments via telemedicine to patients seeking treatment for opioid dependence disorder. The Act essentially prohibits physicians from remotely prescribing any controlled substances through telemedicine unless they first conduct an in-person examination with the patient, or the patient is being treated by and is physically located at a DEA registered hospital or clinic.  However, through the Act, Congress delegated authority to the DEA to create a “special registration” under 21 U.S.C. 802(54)(E), which would allow providers to practice telemedicine without being “subject to the mandatory in-person medical evaluation requirement” under the Act.  Yet, as we discussed in a recent blog, to date the DEA has taken virtually no actions to promulgate any rules that would allow DEA to issue such a special registration.

In October 2017, President Trump declared the opioid epidemic as a public health emergency. As we stated in a November 2017 blog, this declaration technically permits the DEA to authorize a separate method to permit prescription of controlled substances under the Act under 21 U.S.C. 802(54)(D), which would likely not be subject to rulemaking or notice and comment given that such authorization would terminate with the conclusion of the public health emergency.  In conjunction with President Trump’s statement, The President’s Commission on Combating Drug Addiction and the Opioid Crisis recommended the use of telemedicine to assist in expanding access to treatments for patients with opioid dependence disorder.  The Commission explicitly recommended that “federal agencies revise regulations . . . to allow for [substance use disorders] treatment via telemedicine.”  But even with the recent January 2018 extension of the public health emergency declaration until April 23, 2018, the agency has remained silent regarding the exemption.

The letter provides examples of how restricting telemedicine providers from prescribing anti-addiction medication continues to disadvantage rural Americans who do not readily have access to dedicated treatment centers and mental health professionals. For example, the letter states that in Missouri, “98 out of 101 rural counties lack a licensed psychiatrists—“a dangerous scenario that has contributed to higher rates of hospitalizations, emergency room visits, drug addiction and suicide in rural areas.[1]””  The letter directly calls on Acting Administrator Patterson and the agency to “immediately move to expedite the rulemaking process to create a special registration class of providers permitted to prescribe opioid-based medication-assisted addiction therapies via telemedicine.”  The letter emphasizes that the Senators are asking for the agency to take discrete action to treat patients with opioid dependence disorders in rural regions of the country, and not to promulgate a rule that would allow general prescribing of controlled substances for pain management, pain treatment, or any other pain-related purposes.

With the shortage of mental and behavioral health providers in the U.S., it is unsurprising that members of Congress in states with few providers or geographic challenges for patients seeking treatment have become vocal supporters of utilizing telemedicine as a means to combat growing opioid addiction problems in their states. Several state legislatures, including Indiana, Hawaii, and Florida, have or are in the midst of passing legislation to make it easier for providers to prescribe controlled substances to treat opioid dependence disorder via telemedicine.  As the letter stresses, “[t]he severity of the U.S. opioid crises demands nothing less than immediate action on this issue.”

 

[1] The quote was first written in Telepsychiatry helps with mental health burdens in rural Missouri, St. Louis Post-Dispatch, by Michele Munz (May 20, 2017) available at http://www.stltoday.com/lifestyles/health-med-fit/health/telepsychiatry-helps-with-mental-health-burdens-in-rural-missouri/article_495462ea-0ccb-58ee-9aa1-ce32930398ba.html.

You need not spend much time reading the news to know that recent Hurricanes Harvey and Irma have disrupted the lives of tens of thousands of individuals, many of whom may already have behavioral health needs; however, the trauma caused by these recent natural disasters, and others, has created an immense need for additional behavioral and mental health services. For example, a 2012 study entitled “The Impact of Hurricane Katrina on the Mental and Physical Health of Low-Income Parents in New Orleans” reported elevated rates of incidence of Post-Traumatic Stress Disorder (“PTSD”), depression, and a need for mental health services for as much as 50 percent of the low-income population affected by Hurricane Katrina, which hit in August 2005. A Fortune Magazine article reported elevated incidences of PTSD, depression, and anxiety experienced by victims of Hurricane Sandy, which hit in October 2012. In the wake of Hurricane Harvey, some telehealth providers have offered free telehealth services to hurricane victims and a few behavioral health providers have established specific programs focused on providing access to behavioral health services. However, additional services are still needed to treat the long-term mental health needs of these victims.

Providers of health services, especially behavioral health services, who utilize telehealth technologies to treat and diagnose victims of natural disasters, should be acutely aware of certain limitations in state laws that may create liability associated with the services they are providing. Treating victims of natural disasters through telehealth technologies can be difficult because a treating provider must determine the patient’s home state and quickly assess how this may affect the provider’s ability to treat the patient; yet, answering this seemingly simple question can be extremely difficult given the uncertainty and displacement for many in the wake of a natural disaster. Consider the following examples involving Amanda, a Houston resident driven from her home by Hurricane Harvey who has decided to seek the services of a psychologist to deal with the significant emotional and psychological upheaval caused by the recent events:

  • Scenario #1: Amanda’s Houston home has been destroyed, so she purchases a new home in another state. In this scenario, a psychologist treating Amanda must be licensed to practice in the new state where Amanda now lives.
  •  Scenario #2: Amanda’s Houston home is damaged, but is not destroyed, so she plans to move back to Houston once the home has been repaired. In the interim, Amanda moves in with family located in Indiana. Ind. Code § 25-1-9.5-7(b) is fairly clear in that a “Telemedicine Provider Certification with the Indiana Professional Licensing Agency . . . [is required] before the provider may establish a provider-patient relationship or issue a prescription for an individual located in Indiana.” Thus, a psychologist treating Amanda must be licensed to practice in Indiana.
  •  Scenario #3: Amanda’s Houston home is damaged, but is not destroyed, so she plans to move back to Houston once the home has been repaired. In the interim, Amanda moves in with family located in West Virginia. W. Va. Code § 30-21-3 allows a psychologist to practice up to ten days per year without seeking licensure or providing any notice to the State. Therefore, Amanda could seek limited treatment from an out-of-state psychologist; however, the psychologist must become licensed in West Virginia if the repairs to Amanda’s home cannot be completed (and, thus, she does not move back to Houston) before her eleventh day of treatment. Please also note that this law pertains to psychologists, only; if Amanda seeks treatment from a psychiatrist or a therapist, different West Virginia laws and regulations may apply.

The question that must be addressed at the very onset of taking on a new patient, or learning that an existing patient has moved, is whether the provider is even permitted by law to treat the patient utilizing telehealth technologies. If the telehealth program through which the provider is treating the patient is only established in one or a few states, the provider may lack the proper professional licensure to provide treatment to patients who move, or even temporarily relocate, to a different state.  Some states, like Washington, have special temporary provisions that will allow a provider to treat patients residing in the state without requiring that the provider obtain a full and unrestricted license to practice; however, many more states do require that providers obtain full and unrestricted licenses to practice in the state before the provider may treat any patients who are residing in the state, even temporarily.  Some states, like West Virginia, may establish a “middle ground” by allowing for limited treatment of patients without having a full and unrestricted license to practice in the state.

Even if a physician has the proper professional licensure to treat a patient residing in a given state, the provider also must understand what the state requires the provider to do in order to establish a physician-patient relationship, as well as any limits placed on the provider’s ability to treat the patient using telehealth technologies under the state’s relevant laws. For example, in Arkansas, a physician-patient relationship may not be established through telehealth means.  Ark. Code Ann. § 17-80-118(e)(1) requires the treating telehealth physician to either already have a relationship with the patient or to act in concert with another provider who has established such a relationship with the patient.  Yet, the opposite is true in other states, including California, where a physician-patient relationship may be established through telehealth means to the extent that the physician can conduct an examination of the patient (utilizing telehealth technology) that is sufficiently comprehensive for the treatment being provided to the patient. Additionally, the treating physician must ensure that any medication she/he prescribes through telehealth encounters can be prescribed under the state’s remote prescribing laws. Most states require that an in-person visit has occurred between the physician and the patient before certain classes or schedules of drugs may be prescribed. This is further complicated by the fact that states often differ with regard to how they schedule these drugs. As a result, a physician may not be able to newly prescribe or help a patient maintain an existing prescription using certain prescription-only drugs, if the patient moves to a state with these types of restrictions in place.

In spite of these potential regulatory obstacles, behavioral health providers have tough choices to make between managing the potential risks of non-compliance with treating victims of natural disasters who can benefit greatly from having access to behavioral health services. Providers can consider options such as establishing questionnaires that request even temporary or part-time address information from patients, so that the providers have this information at the outset of their interactions with the patient rather than learning this information during the initial (or later) therapy sessions. Providers would then have the option to consult counsel or directly discuss the issue with state regulators, if the application of state laws of one possible “home state” could potentially limit or change how the provider would treat the patient, or to give providers the option of seeking a professional license from any additional states in order to provide services to such patients in a compliant manner.

Private payer parity laws generally require private insurers and health maintenance organizations to cover, and in some cases also reimburse, for the provision of telehealth services in the same manner and at the same level as comparable in-person services. These laws are enacted at the state level, creating a complicated framework within which insurers must operate. At this point, most states have implemented some form of private payer parity law, although the specifics of each state’s laws vary. One of the most common is a rule such as Montana’s, which requires insurers to offer coverage for health care services provided by a health care provider by means of telemedicine if the services are otherwise covered by the plan. Some states, like Iowa, only mandate parity within their Medicaid programs without extending the mandate to private payers. Other states only require parity for certain types of services, like mental health services in Alaska. Lastly, Illinois and Massachusetts, require parity only when insurers opt to provide telehealth services.

In the 2017 legislative session thus far, two more states have enacted private payer parity laws. In April, North Dakota enacted its law, SB 2052, which prohibits policies that provide health benefits coverage to be delivered, issued, executed, or renewed that do not provide coverage for health services delivered by means of telehealth. Although SB 2052 does not require reimbursement for telehealth to match in-person services, it does permit establishing reimbursement for telehealth services through negotiations conducted by the insurer with the health services providers in the same manner as used for in-person services. At the end of June, New Jersey passed its law, requiring health benefits plans to “provide coverage and payment for health care services delivered to a covered person through telemedicine or telehealth, on the same basis as, and at a provider reimbursement rate that does not exceed the provider reimbursement rate that is applicable, when the services are delivered through in-person contact and consultation in New Jersey.” Pennsylvania’s bill, prohibiting a health insurance policy or ancillary service plan from excluding a health care service for coverage solely because the service is provided through telemedicine, is still pending.

Recent efforts in other states to enact telehealth private payer parity laws have not been as successful. A number of parity bills died in the last legislative session, including in Iowa, Kansas, Idaho, and Massachusetts. A bill in Florida that would have created tax credit for health insurers and health maintenance organizations that cover telehealth services also failed. At present, 15 states do not yet mandate private payers to cover and reimburse telehealth services at the same level as in-person health care services. In addition to the aforementioned, Alabama, Illinois, North Carolina, Ohio, South Carolina, South Dakota, Utah, Wisconsin, West Virginia, and Wyoming all lack such laws or regulations.

We continue to track the progress of bills in state and federal legislatures. If you have questions on coverage and reimbursement for telehealth services, please reach out to Epstein Becker Green’s Telehealth & Telemedicine team to learn more about our capabilities. Additionally, we are in the process of updating our state survey on telemental health laws. Check back soon for additional details.

Telemental health seems to be emerging, even booming.  Also referred to as telebehaviorial health, e-counseling, e-therapy, online therapy, cybercounseling, or online counseling, for purposes of this post, I will define telemental health as the provision of remote mental health care services (usually via an audio/video secure platform) by psychiatrists, psychologists, social workers, counselors, and marriage and family therapists.  Most services involve assessment, therapy, and/or diagnosis.   Over the last few years, I have seen a wider variety of care models—from hospitals establishing telepsychiatric assessment programs in their emergency departments to virtual networks of mental health professionals providing telemental health services to underserved areas to remote substance abuse counseling being provided to inmates in state prisons.VA telehealth

Even the federal government is in on the act.  For example, in 2010, the Veterans Health Administration established a National Telemental Health Center. In 2013, the center provided almost 3,000 video encounters to 1,000 patients at 53 sites in 24 states.  The scope of the services the center provides includes all mental health conditions with a focus on post-traumatic stress disorder, depression, compensation and pension exams, bipolar disorder, behavioral pain and evidence-based psychotherapy.

There are many reasons for the recent boom.  First, telehealth is a good fit for providing mental health services because providers rarely have to lay hands on the patient in conventional face-to-face encounters.  Second, telemental health is accepted by a large number of payers as a legitimate use for telehealth—more so than other telehealth disciplines. As an example, most Medicaid programs and many private insurers cover and reimburse for telemental health services.  Finally, patients surveyed have consistently stated that they believe telemental health to be a credible and effective practice of medicine, and studies have found little or no difference in patient satisfaction as compared with face-to-face mental health consultations.

The Need for Telemental Health

In essence, we are stuck in a vortex of sorts with millions of Americans suffering from mental illness or substance abuse disorders combined with a shortage of qualified mental health providers to address these issues.  The numbers speak for themselves.

In addition to the high numbers described above, there is a critical mental health provider shortage creating significant access to care issues.  Here is a snapshot:

You get the idea.  And even with mental health parity laws, cost of care remains an issue—not to mention the social stigma and mistrust of mental health providers that exists in many communities.Mobile phone

Telemental health is bridging the gap.  Numerous studies have shown the effectiveness of telemental health services.  For example, a recent study showed that providing telemental health services to patients living in rural and underserved areas significantly reduced psychiatric hospitalization rates.  Another study concluded that the effects of telemental health on low-income homebound older adults were sustained significantly longer than those of in-person mental health services. Many other studies arrive at the same conclusion.  Note, however, obstacles remain, including how to properly assess non-verbal cues by video, technical difficulties, and the lack of proper training of many providers regarding telehealth.

Practice Guidance

There is also good news in that, unlike other telehealth subspecialties, there is a well-developed library of practice guidelines available regarding telemental health.  The American Psychiatric Association, American Psychological Association, National Association of Social Workers, Association of Social Work Boards, TeleMental Health Institute, for example, all have guidelines or statements related to telemental health.  The American Telemedicine Association has developed a series of practice guidelines over the years related to telemental health, including its latest regarding using real-time videoconferencing to provide online mental health services. There are also other resources such as the telehealth resource centers that provide guidance on telemental health.

Legal & Regulatory Issues

As with all things telehealth, however, there are a number of significant legal and regulatory issues implicated by the use of telemental health, including privacy and security, follow-up care, emergency care, treatment of minors, and reimbursement. While telemental health touches on some federal laws and regulations (e.g., HIPAA), most of the significant issues involve state law.  And as you might imagine, the result is an inconsistent patchwork of laws and regulations that vary widely by state.

We recently completed a 50-state survey of laws and regulations that may be implicated by the use of telemental health services to assess a variety of issues such as privacy, follow-up care, treatment of minors, and provider scope of practice.  Here are a few nuggets:

  • Psychiatrists, as practicing physicians, must comply with all the obligations that apply to physicians practicing telehealth generally. Very few states exempt mental health from physician requirements despite the fact that many psychiatrists never lay hands on patients. Ironically, Texas is one of the few states that explicitly carves out mental health services from other telehealth requirements.
  • In Delaware, an individual practicing “telepsychology” must conduct a risk benefit analysis and document findings specific to issues such as whether a patient’s presenting problems and Skype 4apparent condition are consistent with the use of telepsychology to the patient’s benefit; and whether the patient has sufficient knowledge and skills in the use of technology involved in rendering the service or can use a personal aid or assistive device to benefit from the service.
  • Kansas requires psychologists and social workers providing telemental health services to obtain the informed consent of the patient before services are provided.
  • In Maryland, physicians (psychiatrists) are required to develop a procedure to prevent access to data by unauthorized persons through password protection, encryption, or other means; and develop a policy on how soon an individual can expect a response from the physician to questions or other requests included in transmission.
  • Montana psychologists can initially establish a “defined professional relationship” electronically so long as the means of communication involves a two-way, real-time, interactive platform providing for both audio and visual interaction.
  • To regulate marriage and family therapy therapist, South Dakota relies on the American Association for Marriage and Family Therapy’s Code of Ethics which provides that therapists evaluate whether electronic therapy is appropriate for individuals and inform them of the potential risks and benefits associated with electronic therapy.

As I look over the telehealth landscape, I predict that telemental health will continue its significant growth.  Demand for mental health services will not recede, and coupled with the mental health provider shortage, telemental health will be viewed as a viable solution by more and more clinicians, payers, and policymakers.  There are, however, significant legal and regulatory considerations—especially at the state level— with which stakeholders must wrestle.