At first blush, the passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), appears to address the issue concerning the lack of regulatory guidance regarding the “Special Registration” exception to the Ryan Haight Act of 2008; however, a deeper and more careful analysis reveals that the Bill may not be as effective as most health care practitioners may hope. The Bill, sponsored by Rep. Carter (R-Georgia), a pharmacist, Rep. Bustos (D-Illinois), and nine others, cleared the House on June 12, 2018 without objection. The Bill would require the federal Drug Enforcement Agency (“DEA”) to promulgate rules that would allow health care providers to apply for a “Special Registration” that would allow a provider to prescribe controlled substances via telehealth without first conducting an initial in-person examination of the patient. A transcript of the testimony in support of the Bill (“Transcript”) reveals enthusiasm by the sponsors of the Bill, as well as by Representatives Pallone (D-New Jersey) and Walden (R-Oregon), who called the Bill “a commonsense measure that cuts through the red tape to provide more treatment options to underserved communities through the use of telemedicine.” While Section 413 of the current version of S.B. 2680 would only give the DEA six months to promulgate such rules, the two bills are very similar and almost guarantee that a law will be signed in the coming months that will require DEA to promulgate rules that will finally create a Special Registration exception to the Ryan Haight Act. While the prospect of rules implementing the Special Registration may be exciting for many practitioners, it should be noted that the DEA has been obligated to create these regulations, and has ignored this obligation, for a decade.

Once enacted, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”) effectively banned the prescription of controlled substances via telehealth without an in-person examination of the patient. While there are exceptions to the Act, these exceptions are very technical and do not apply to the majority of treatment settings for which a controlled substance could be prescribed by a treating physician to a patient in his or her home. When the Act was passed, Congress appeared to have the foresight to know that the Act was restrictive and that the Act should have some mechanism by which its prohibitions could be relaxed, because the Act also created 21 U.S.C. § 831(h)(2), which orders the Attorney General of the United States and the DEA to “promulgate regulations specifying the limited circumstances in which a special registration under this subsection may be issued and the procedures for obtaining such a special registration.”  However, as we have previously discussed, the only related action the DEA has taken in the decade between the passage of the Act and today was, in 2016, to mark the creation of these rules a “Long-Term Action” that has not substantively been addressed. By suggesting that the DEA “understand[s] the need to implement this provision of law” Rep. Walden appears to be incognizant of the historical lack of the DEA’s movement to promulgate the Special Registration rules, despite the DEA having the authority to do so since the Act originally was passed in 2008. Mr. Walden also seems to advocate for the DEA, as he supports revising the Bill’s original 90-day deadline for the promulgation of rules to implement a one-year deadline on account of the DEA’s position it would be burdensome. As such, the question remains whether the DEA, who has avoided this exact obligation for nearly a decade, will at last take action within the year if the Bill becomes law.

Even if the DEA promulgates rules to create the Special Registration, there is no indication how broadly such rules will be written. In this regard, the transcript illustrates a fundamental difference in how Representatives Walden and Carter view the value of the DEA creating a Special Registration process and, importantly, what the scope of that Special Registration process should be from many psychiatrists and other practitioners. For example, Rep. Walden described the exception to the Act in narrow terms: “for emergency situations, like the lack of access to an in-person specialist” (a phrase also used by Rep. Carter). Mr. Carter stated as well that the original purpose of the Special Registration was for “legitimate emergency situations” as follows:

“The law included the ability for the Attorney General to issue a special registration to healthcare providers detailing in what circumstances they could prescribe controlled substances via telemedicine in legitimate emergency situations, such as a lack of access to an in-person specialist.”

Rep. Carter further stated that the Special Registration could serve as a tool to fight the opioid crisis “to connect patients with the substance use disorder treatment they need without jeopardizing important safeguards to prevent misuse or diversion,” but he did not speak of the Special Registration in broader terms. The statements by Reps. Walden and Carter mischaracterize the original language of the Act regarding the “Special Registration for Telemedicine,” which does not limit the Special Registration to emergency situations.  Rather, the Act explicitly authorizes the Attorney General to issue the Special Registration to a practitioner who “demonstrates a legitimate need for the special registration” without defining the phrase “legitimate need”. As such, “legitimate need” could include “emergency situations” but also could be interpreted to include circumstances under which a physician is authorized to prescribe a controlled substance via telehealth as long as such prescription is in accordance with the substance’s label or the applicable standard of care for treatment of the illness for which the prescription was issued to treat,

If the DEA takes its cues from the recent House testimony supporting the Bill, the agency may decide the Special Registration should be limited to certain declarations of emergencies, such as the declaration of the opioid crisis as a Public Health Emergency. Such a narrow definition may be fruitful in the fight against opioid use disorder, but may ultimately fall short of expectations held by telehealth practitioners interested in providing services to patients via telehealth that involve prescribing controlled substances.

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.

On October 26, 2017, President Trump directed the Secretary of the Department of Health and Human Services (“Secretary”) to declare a National Public Health Emergency on the opioid epidemic. While the President offered few details regarding how his administration will address the challenge of treating patients struggling with opioid addiction, a previous statement from the White House indicated that the Administration plans to expand access to treatment via telemedicine and more specifically, remote prescribing of the necessary controlled substances used to treat these patients. While this is a logical step, and one that has been advocated at length by states and health care experts, alike, expanding health care providers’ capabilities to utilize remote prescribing to treat opioid addiction will likely run afoul of existing federal law.

The Ryan Haight Online Pharmacy Consumer Protection Act (“Act”) was passed by Congress in 2008 following the death of Ryan Haight, an 18-year-old honor student who overdosed on prescription narcotics delivered to his door by an internet pharmacy based on a prescription written by a physician he had never seen. The Act amended the federal Controlled Substances Act and requires a prescribing practitioner to be physically present when prescribing, or allowing to be prescribed by a remote practitioner, a controlled substance, if the prescribing practitioner has not previously conducted an in-person physical examination of the patient. However, some have viewed the Act as establishing a significant barrier to the progress of telemedicine. In the words of former Rep. Mary Bono (R-Calif.), “the issue back then is very different from what the issue has become.”

Today, telemedicine has exploded. In just the last year, nearly every state has enacted new legislation that either expands access to telemedicine services, expands parity for reimbursement for telemedicine services, and/or loosens previous restrictions on telemedicine interactions (e.g., establishing practitioner-patient relationships) and remote prescribing. In stark contrast, the federal government has made little to no attempt to modify the antiquated Act to keep up with the telemedicine advancements since it was passed in 2008. Practitioners must now navigate their telemedicine practices around the Act since there are few exceptions to the Act and violations of the Act are considered violations of the Controlled Substances Act, which include fines, penalties, disbarment, and incarceration. With such stiff consequences and the lack of guidance or regulatory measures promulgated by the Drug Enforcement Agency, practitioners are unlikely to prescribe drugs to treat opioid-addicted patients that are most vital to their treatment.

Ironically, the World Health Organization deemed methadone and buprenorphine, two controlled substances, to be “essential medicines” in the treatment of opioid addiction. Studies have shown strong inverse linear association between heroine overdose deaths and patients being treated with opioid agonist treatments, including methadone and buprenorphine. As such, the ability to treat patients effectively through telemedicine and remote prescribing will often require prescribing drugs currently prohibited for such prescription. This realization has come to many policy makers and telemedicine organizations. Most of these individuals and organizations have called for amendment or repeal of the Act; however, one possible interpretation of the Act could allow for remote prescribing of controlled substances to treat opioid addiction under the telemedicine public health emergency declaration exemption of the Act.

Within the Act, Section 802(54)(D) (21 U.S.C. 802(54)(D)) permits the remote prescribing of controlled substances “during a public health emergency declared by the Secretary” and to the extent that the prescribing “involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates . . . .” On October 26, 2017, the Secretary, as directed by the President, issued the following statement regarding the public health emergency:

As a result of the consequences of the opioid crisis affecting our Nation, on this date and after consultation with public health officials as necessary, I, Eric D. Hargan, Acting Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby determine that a public health emergency exists nationwide.

Although a declaration of a public health emergency normally includes specific geographic parameters rather than blanket “nationwide” issuance, based upon the Secretary’s declaration, one could argue that health care practitioners seeking to treat patients dealing with opioid addiction now must only await the list of controlled substances (to be issued by the Secretary and the U.S. Attorney General) before they are able to remotely prescribing controlled substances to treat opioid addiction. However, even if the Attorney General were to agree with this interpretation of Section 802(54)(D)’s application and to provide a list of controlled substances that can be prescribed thereunder, 42 U.S.C. 247d only permits a declaration of a “public health emergency” to be in place for a maximum of 90 days. Therefore, utilizing Section 802(54)(D) to allow remote prescribing to treat opioid addiction through telemedicine will only serve as a temporary patch, while the bigger issue of amending the Ryan Haight Act needs to be addressed by Congress. In the words of Ms. Bono, “if the Ryan Haight Act needs to be updated, then let’s update it.”

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.