Telehealth and Telemedicine

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.

Effective June 11, 2018, all Department of Veterans Affairs (“VA”) health care providers will be able to offer the same level of care to all beneficiaries regardless of the beneficiary’s or the health care provider’s location. In its recently released final rule, the VA stated that in December 2016 Congress mandated that the agency provide veterans with a self-scheduling, online appointment system, and that the agency meet the demands for the provision of health care services to veterans, regardless of whether such care was provided in-person or using telehealth technologies. As a general rule, most telehealth practitioners are required to comply with various and state-specific licensing, registration, and certification requirements in order to render health care services via telehealth. Failure to do so can potentially jeopardize a practitioner’s professional credentials and could expose them to penalties including fines and imprisonment for the unauthorized practice of medicine or other health care services. These state-specific requirements create certain challenges for telehealth practitioners seeking to practice across state lines.

Therefore, in order to address the mandate issued by Congress, the VA developed and published the final rule to supersede these state-to-state regulations by clarifying that VA health care providers may exercise their authority to provide health care services via telehealth, notwithstanding any state laws regarding licensure, registration, or certification requirements that might be conflicting with taking these actions. Essentially, the VA is exercising its authority as a federal agency to preempt conflicting state laws relating to the practice of medicine or other health care services via telehealth. These efforts by the VA are designed to better protect its health care providers from potential enforcement actions by individual states and/or their respective professional boards, provided that these practitioners are providing telehealth services within the scope of their VA employment.

It must be noted that the final rule’s scope is narrow and only applies to health care providers who are employed by the VA. The final rule does not cover contractors, including health care providers who are participating in the Choice Program. The final rule also does not expand the scope of practice for VA health care providers beyond what is required or authorized by federal laws and regulations or the laws and regulations relating to the practice of medicine or other health care services that are dictated by the state(s) in which the health care provider is licensed to practice. Additionally, the final rule does not affect the VA’s existing requirement that all VA health care providers must adhere to all applicable laws and regulations regarding prescribing and administering of controlled substances, which not only obligates a provider to comply with such laws in the state(s) where he/she is licensed to practice, but also with the federal Controlled Substances Act.

Among the public comments submitted in response to the VA’s proposed rule, published October 2, 2017, the Federal Trade Commission, an agency that has been a big proponent of efforts to expand access to telehealth services, applauded the amendments to the VA’s regulations, stating that it will “provide an important example to non-VA health care providers, state legislatures, employers, patients, and others of telehealth’s potential benefits and may spur innovation among other health care providers and, thereby, promote competition and improve access to care.”

Telehealth providers and stakeholders should closely follow the VA’s progress as the agency works to implement the final rule. Any resulting successes, as well as any failures, may meaningfully impact the continued expansion and adoption of telehealth technologies and services among the private and commercial sectors, as well as potentially influence continued state legislative efforts in this developing area.

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently released a report revealing that during OIG’s 2014 and 2015 audits of telehealth claims, more than half of the professional telehealth claims paid by the Medicare program did not have matching originating-site facility claims.

According to the report, Medicare telehealth spending increased from $61,302 in 2001 to $17,601,996 in 2015. Among the 191,118 Medicare paid distant-site telehealth claims (totaling $13,795,384), the OIG randomly sampled 100 of those claims and obtained supporting documentation to determine whether the paid telehealth services were allowable under the Medicare requirements. Approximately a third of the claims did not meet certain Medicare requirements, including:

  • 24 claims were unallowable because beneficiaries received services at non-rural originating sites that did not fall under the demonstration program exception. For proper telehealth Medicare reimbursement, beneficiaries must be located in either: (1) an HPSA that is outside of an MSA or within a rural census tract of an MSA, as of December 31 of the preceding year, or (2) a county that is not included in an MSA as of December 31 of the preceding year. Providers should check whether their patients’ location qualify as an originating site via the Medicare Telehealth Payment Eligibility Analyzer.
  • 7 claims were billed by ineligible institutional providers. Institutional facilities at a distant site may bill Medicare only if: (1) the facility is a CAH that elected the Method II payment option and the practitioner reassigned his or her benefits to the critical access hospital (CAH) or (2) the facility provided medical nutrition therapy (MNT) services.
  • 3 claims were for services provided to beneficiaries at unauthorized originating sites. Telehealth services must be furnished to a beneficiary that is located in one of the following sites: the office of a practitioner, a hospital, a CAH, a rural health clinic, a federally qualified health center, a hospital-based or CAH-based renal dialysis center, a skilled nursing facility, or a community mental health center.
  • 2 claims were for services provided by an unallowable means of communication. Under the Federal regulations, telehealth practitioners must provide telehealth services using an interactive telecommunications system, which excludes telephone, fax, or email. However, CMS provides a carve-out for asynchronous store and forward technology for Federal telemedicine demonstration programs in Alaska and Hawaii.
  • 1 claim was for a non-covered service. Practitioners should refer to the CMS website for the list of telehealth services payable under the Medicare physician fee schedule. Changes to the list are made annually.
  • 1 claim was for services provided by a physician located outside the U.S. Telehealth services are only covered if those services are provided within the U.S.

The OIG largely cited that many of these claims should not have been approved and reimbursed in the first place. For example, the majority of claims related to unallowable geographical locations of the originating sites. Presently, Medicare Administrative Contractors (MACs) do not have a process of editing these types of errors because claim forms do not have designated field for the originating-site location. The claim forms also do not have a field determining the form of communication used by the practitioner. CMS officials stated that it would be unlikely that the forms would include such designations because those designations would not be applicable to non-telehealth practitioners who use the same claim forms.

The OIG recommended that CMS take the following actions:

  • Conduct periodic post-payment reviews for errors for which telehealth claims edits cannot be implemented;
  • Work with MACs to implement all telehealth claim edits listed in the Manual; and
  • Offer education and training sessions to practitioners on Medicare telehealth requirements and related resources.

To date, there have not been any reported cases of enforcement actions taken against telehealth practitioners and stakeholders. However, practitioners and stakeholders should be aware that qui tam actions under the False Claims Act (FCA) may be brought by whistleblowers. The first FCA case was brought in 2016 where a Connecticut mental health practice allegedly submitted false claims to Medicare for telehealth service provided to patients. The complaint alleged that the physician and mental health practice did not use interactive audio and video communications, but simply treated Medicare beneficiaries over the telephone. Although that settlement only amounted to $36,704, the recent OIG report should signal to telehealth practitioners and stakeholders that OIG is now aware and will most likely hold telehealth service providers more accountable for complying with both Federal and state telehealth laws and regulations.

Therefore, practitioners and stakeholders should familiarize themselves with Medicare telehealth requirements as they will most likely change in the next several months, seen most recently with the passage of the Bipartisan Budget Act of 2018, which expanded coverage of telehealth services under Medicare related to telestroke care, Medicare Advantage, and accountable care organizations.

In March 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) made its 2018 report to Congress, which included the Commission’s evaluation of telehealth services provided through the Medicaid program. Chapter 2 of MACPAC’s report had a positive outlook on telehealth’s contribution toward better accessibility of health care services to underserved individuals as well as individuals with disabilities.

Unlike its larger counterpart, Medicare, federal policy has not placed many restrictions on state Medicaid programs in terms of adopting or designing telehealth coverage policies. For example, there is limited reimbursement coverage of telehealth services provided through the Medicare Fee-For-Service (FFS) program (e.g., geographical restrictions). However, there is little federal guidance or information regarding the implementation of telehealth services in state Medicaid programs or coverage for these services. As a result, state Medicaid coverage of telehealth services is highly variable across state lines, in terms of telehealth modalities, specialties and services, provider types, and even permissible site locations where telehealth services may be rendered. This high degree of variability stems, at least in part, from the unique federal-state partnership that provides the foundation for all state Medicaid programs.

Federal Medicaid Program Requirements. Although the federal requirements for coverage of telehealth services provided through the Medicaid program are few, in comparison to comparable requirements under the Medicare FFS program, some broad CMS guidelines do require Medicaid providers to practice within the scope of their state practice laws and to comply with all applicable state professional licensing laws and regulations. Additionally, any payments made by state Medicaid programs for telehealth services must satisfy the federal Medicaid program requirements for efficiency, economy, and quality of care. Furthermore, although Medicaid program requirements for comparability, state-wideness, and freedom of choice do not apply to telehealth services, states choosing to limit access to telehealth services (e.g., limited to particular providers or regions) must ensure access to and cover face-to-face visits in areas where such services are not available. Moreover, states are not required to submit a Medicaid state plan amendment to cover and pay for telehealth services as long as the program is in a state where telehealth parity laws are in effect, which are intended to ensure same coverage and payment of telehealth services as those provided in-person.

State-to-State Variations in Medicaid Coverage of Telehealth Services. A big focus of the MACPAC report was the impact that state-by-state variations may have on providing access to telehealth services through state Medicaid programs. As previously noted, because of the lack of any unified federal telehealth policy, state Medicaid program coverage of telehealth services is inconsistent. Some states, like West Virginia, mirror their Medicaid policies and regulations after the Medicare program, meaning that telehealth services are covered only if the originating site is in a rural location that either meets the definition of a non-metropolitan statistical area or a rural health professional shortage area, or originating site must be at hospitals, critical access hospitals, physician offices, federally qualified health centers, etc. In other words, in these states, Medicaid recipients would be required to travel to particular qualified locations for their telehealth service to be covered under Medicaid. Interestingly, MACPAC reported that some states that initially adopted these Medicare-like standards have changed their policies over time, as the state Medicaid programs have gained experience and understanding of the implications for access, cost, and quality. Other states are increasingly allowing homes, workplaces, and schools to serve as originating sites for telehealth services, while some states do not explicitly require patients to be at any specific sites in order to receive telehealth services. For example, while West Virginia’s Medicaid program specifies that originating sites must be a physician’s or other health care practitioner’s office, hospitals, rural health centers, skilled nursing facilities, etc., Medicaid recipients in Washington state may choose the location they would like to receive telehealth services, without these types of restrictions.

Similarly, the types of telehealth services that are covered vary greatly from state-to-state. For example, Idaho’s Medicaid program covers live video telehealth for mental health services, developmental disabilities services, primary care services, physical therapy services, occupational therapy services, and speech therapy services. In contrast, Arizona’s Medicaid program covers live video telehealth for a variety of specialty services including cardiology, dermatology, endocrinology, pediatric subspecialties, hematology-oncology, home health, infectious diseases, neurology, obstetrics and gynecology, oncology and radiation, ophthalmology, orthopedics, pain clinic, pathology, pediatrics, radiology, rheumatology, and surgery follow-up and consultation.

Across state Medicaid programs there also is wide variation regarding the types of health care practitioners who may provide telehealth services to Medicaid program recipients. Nineteen states (e.g., Connecticut, Florida, Hawaii, Iowa, Kansas, Louisiana, Maine, Massachusetts, Mississippi, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Tennessee, Utah, and Vermont) do not specify the type of providers that may provide health care services via telehealth and therefore are presumed to have the most inclusive provider policies. There also is variation with respect to professional licensure requirements for these providers, with some state policies allowing out-of-state practitioners to provide telehealth services as long as they are licensed in the state from which they are providing the service and are registered with the state’s Medicaid program (e.g., Arizona) while other state policies require practitioners to be licensed or certified to practice in the state unless only providing episodic consultation services (e.g., Arkansas).

States set their own payment levels for telehealth services provided to Medicaid recipients. Some payment rates for telehealth services may be lower than payment rates for the same services provided in-person. State Medicaid programs also vary in terms of payments for facility fees and transmission fees, which assist providers with covering associated telecommunications costs. Additionally, state Medicaid policies for telehealth services may differ between managed care and FFS plans. Some states do not require Medicaid managed care plans to provide services via telehealth at all. For example, Florida’s live video telehealth is covered under Medicaid FFS but is optional for Medicaid managed care plans, while in Massachusetts telehealth services are not covered under Medicaid FFS but there is some coverage under at least one of the state’s Medicaid managed care plans.

Despite these variations, MACPAC found that Medicaid plays a significant role as a payor with respect to the following types of telehealth services:

Behavioral Health. MACPAC reported that non-institutionalized adult, children, and adolescents covered by Medicaid have a higher rate of behavioral health disorders compared to their privately insured counterparts. Barriers to care include fragmented delivery systems, lack of accessibility to provider and resources, and patients’ concerns regarding confidentiality and fear of stigma attached to seeking mental treatment. MACPAC reported that there is increasing evidence that telehealth has the potential to improve access to evidence-based care for mental health and substance use disorders for individuals located in underserved areas. As of now, all state Medicaid programs that cover telehealth services include as part of that coverage access to behavioral health services via videoconferencing, although the scope of coverage varies state-to-state. Generally, most commonly covered services include mental health assessments, individual therapy, psychiatric diagnostic interview exams, and medication management. Although most state Medicaid programs will cover behavioral health services via telehealth if provided by licensed or certified psychiatrists, advanced practice nurses, and psychologists, some states also will cover those services if treatment is delivered by social workers and/or counselors. MACPAC reported that there is a growing number of studies showing that behavioral health care services provided via telehealth is effective, particularly for assessment and treatment of conditions such as depression, post-traumatic stress disorder, substance use disorder, and developmental disabilities. MACPAC reported high patient satisfaction with behavioral health care services via telehealth was on par with non-Medicaid payor populations, although MACPAC indicated that more research is needed.

Oral Health. Oral health services among Medicaid participants are relatively low. Barriers to oral health care include cost, difficulty of finding dentists who accept Medicaid, and inconvenience of location and time. MACPAC reported that the use of telehealth in dentistry has been recognized for its potential in improving access to primary and specialty oral health care services in communities that either lack or have limited provider capacity. Typically a patient is joined by an oral health professional at the originating site during a real-time video consultation with a dentists or specialty dentists for diagnosis and development of a treatment plan. Store-and-forward modality allows the provider at the originating site to send images (i.e., x-rays, photographs, lab results) to the dentist for review. As of 2017, 11 states were identified for including some Medicaid coverage for teledentistry (e.g., Arizona, California, Colorado, Florida, Hawaii, Minnesota, Missouri, Montana, New Mexico, New York, and Washington). Studies have shown that certain teledentistry services such as screening of childhood dental caries and orthodontic referrals appear to be as effective as in-person visits. MACPAC reported that patients expressed satisfaction of these dental health care services provided via telehealth because of greater convenience and improved access to care.

Maternity Care. In 2010, although state Medicaid programs covered nearly half of all births in the U.S., nearly 50 percent of U.S. counties had no obstetrician-gynecologists providing direct patient care. Telehealth can be used to manage pregnancies in several ways including the use of videoconferencing between a patient and her regular maternity care provider or between two providers during labor and delivery. Live videoconferencing could also be utilized during genetic counseling or even neonatal resuscitation. MACPAC reported that pilot studies have tried videoconferencing for prenatal care visits, group prenatal care, and breastfeeding support, which include women with both high-risk and low-risk pregnancies. MACPAC also reported that an emerging practice is the use of telehealth to diagnose congenital heart defects via live videoconferencing between the radiographer and fetal cardiologists, or the use of store-and-forward technology to allow a specialist to review echocardiograms post hoc.

MACPAC Recommendations. Before integrating or expanding telehealth services in their respective Medicaid programs, MACPAC recommended that states weigh the costs and the resource requirements associated with using or implementing telehealth against their goals of improving access for Medicaid recipients to needed health care services. One of the primary concerns voiced against greater use of telehealth services is the inappropriate use or overuse of those services. For example, MACPAC asked the states to consider whether inclusion of facility or transmission fees would increase the overall costs to their Medicaid programs if telehealth services replaced in-person services. MACPAC also asked states to consider whether telehealth services had the potential to increase fragmentation of care if services were provided by different telehealth providers or providers were unable to obtain updated patient medical records. MACPAC emphasized that while there appeared to be growing number of studies showing the effectiveness of telehealth services, there are still very few published studies addressing the effect of telehealth in Medicaid populations.

MACPAC also noted several factors that contributed to limited adoption of telehealth in Medicaid. The combination of lower payment rates for Medicaid and yet potential high costs for licensing across different state lines may deter providers from using telehealth for Medicaid services. Telehealth technology is dependent on reliable and affordable broadband connectivity. Unfortunately many rural areas and Native American reservations still lack such connectivity. An estimated 53 percent of individuals living in rural areas lack access to broadband speeds needed to support telehealth. Furthermore, costs of broadband can be almost three times that in urban areas. Costs associated with the acquisition, installation, and maintenance can be quite cost-prohibitive to providers and affect their ability or willingness to adopt telehealth. Additionally, telehealth-focused remote prescribing laws vary from state-to-state while prescribing of controlled substances are limited by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The law generally prohibits prescribing of controlled substances through the internet without a valid prescription, which requires the prescriber to have conducted at least one in-person medical examination of the patient. Although the law includes a telehealth exemption, the exemption requires the originating site to be located at Drug Enforcement Administration (DEA)-registered clinic or hospital. In addition, state medical licensing boards may also limit the circumstances in which providers can prescribe controlled substances via telehealth. As illustrated above, the varying length and degree of Federal and state laws and regulations governing telehealth services is complex and may deter providers from entering into the telehealth service market.

Overall, the MACPAC report illustrates a positive outlook on telehealth’s integration into state Medicaid programs. However, in its recommendation to Congress, MACPAC did not outright push states to adopt telehealth into their Medicaid programs. Rather, the Commission continues to seek more research and collaborative studies among states to gain better insight and understanding of the effects of telehealth on access to care, quality, and cost of care of the Medicaid program.

Our collegues Helaine Fingold, Daniel Kim, and Amy Lerman at Epstein Becker Green have a post on the Health Law Advisor blog that will be of interest to many of our readers: “CHRONIC Care Act, Title III of the Bipartisan Budget Act of 2018, Signals Meaningful Change for Medicare Advantage Plans and Telehealth Coverage.”

Following is an excerpt:

“…[T]he [Bipartisan Budget Act of 2018 (BBA)] includes certain provisions taken from the CHRONIC Care Act that will provide a needed expansion of Medicare [fee-for-service] coverage for certain telehealth-based chronic care services. The BBA preserves many of the telehealth-focused aspects of the original 2017 bill equivalent and, seemingly, reflects a commitment by the federal government to improving access to telehealth services for qualified Medicare beneficiaries and further integrating these services into the U.S. health care system.”

Read full post here.

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.

In 2008, Congress passed the Ryan Haight Act (21 U.S.C. § 802(54)) (“Ryan Haight”) following the death of Ryan Haight, a young man who overdosed on prescription painkillers he purchased from an online pharmacy without a valid prescription. Ryan Haight amended the federal Controlled Substances Act (21 U.S.C. 802 et seq.) and specifically prohibits dispensing controlled substances via the internet without a “valid prescription” which, according to the law, must be issued for a legitimate medical purpose and may only be issued once a physician has conducted at least one in-person evaluation of the patient (i.e., before issuing the remote prescription for the controlled substance). Certain exceptions may apply, but arguably none contemplate the direct-to-patient virtual care models that many of today’s telehealth / telemedicine companies are utilizing.

The intent behind the enactment of Ryan Haight in 2008 was to shut down online pharmacies and to restrict access to painkillers and other controlled substances provided to patients in ways that could circumvent a physician’s examination (and the issuance of a valid prescription, if the physician determined it was an appropriate course of treatment for the patient). Unfortunately, the effect of enacting Ryan Haight was, in reality, much more significant – not only restricting access via online pharmacies to the deadliest or most addictive painkillers, but also banning the issuance of remote prescriptions for any controlled substances unless an in-person visit occurred first between the physician and the patient. What the requirements imposed by Ryan Haight ignore is that there are many more drugs in Schedules II – V that are designed to treat patients for a panoply of non-pain related illnesses, many of which can be prescribed safely and effectively by means of an appropriate telehealth encounter. While Congress largely has ignored calls to revise Ryan Haight to address this issue, some states have started to rethink how, at least at the state level, they will handle the issue of health care providers prescribing controlled substances through non-traditional treatment arrangements, such as the use of telehealth / telemedicine.

An example is Indiana, where the legislature recently amended Indiana Code 25-1-9.5-8 (in 2017) to expand the list of drugs that may be prescribed by authorized prescribers through telehealth / telemedicine. Originally enacted in 2016, the law banned the remote prescribing of all controlled substances if such prescribing was done via a telehealth / telemedicine encounter. The revised law dramatically expands the ability to prescribe, via telehealth / telemedicine, certain controlled substances, and only limits such prescribing practices with respect to opioids, abortion inducing drugs, and/or ophthalmic devices (i.e., contact lenses and glasses). The Indiana law is particularly thoughtful and timely because it excludes from the ban any opioids that act as partial-agonists are used to treat or manage opioid dependence. Therefore, the Indiana law not only expands treatment options by allowing the remote prescribing of many controlled substances, including some that can be used to treat opioid dependence disorders, but does so in a manner that attempts, discretely, to address the opioid dependence epidemic by limiting access to most opioids.

Following a similar path is Hawaii, which like Indiana has excluded the remote prescription of opioids via telehealth as well as medical cannabis. While Hawaii’s laws do not explicitly permit the remote prescription of controlled substances, the fact that Hawaii Statutes Revised § 329-1 does not distinguish between the prescribing of controlled and non-controlled substances (within the context of discussing the rules related to remote prescribing) and that Hawaii Statutes Revised § 453-1.3 only requires an in-person examination prior to prescription of opioids and medicinal cannabis, would logically support the assumption that prescribing other, less controversial controlled substances would be permissible. Like Hawaii, Florida is another state that has taken a more nuanced approach to remote prescribing of controlled substances via telehealth / telemedicine. Florida Administrative Code rule 64B8-9.0141, for example, permits the prescription of controlled substances to treat psychiatric disorders.

Simultaneously, some states also have continued to build, refine, and expand statewide databases that store information regarding the prescriptions for controlled substances written by practitioners licensed by the state. This information can help physicians and other prescribing health care providers to determine, if and when contemplating the issuance of a remote prescription to a certain patient, whether that patient may be “doctor shopping” and/or whether concomitant medications may pose a risk to a patient if he/she is prescribed a particular drug. These databases, and the laws creating and amending them, may be one reason why states are more willing to expand remote prescribing practices given these new additional safeguards.

By contrast, to date the Drug Enforcement Agency (DEA) has taken no additional steps to clarify or refine the requirements under Ryan Haight since it was enacted. When Ryan Haight was first passed, it included an exception on its applicability for prescribers who obtain a “special registration” from the Attorney General or the Administrator of DEA per 28 CFR 0.100. When Ryan Haight was passed, Congress contemplated that DEA would “promulgate regulations governing the issuance to practitioners of a special registration relating to the practice of telemedicine;” however, neither DEA nor any other agency has provided any additional information regarding this special registration since Ryan Haight was first signed into law in 2008. In 2015, DEA proposed making a rule that would provide clarity to the “special registration” exception; however, in 2016 DEA amended the proposed rule-making to a “Long-Term Action” with no set deadline, further delaying even the idea of providing additional clarity. Perhaps the DEA’s response is a reaction to states that strongly oppose providing prescribing information to other states or even to the federal government for various reasons, including privacy concerns. That is to say, perhaps states are more willing to loosen remote prescribing laws for controlled substances because the databases they control and the data provided thereunder have eased concerns with allowing prescribers to prescribe as they see fit based on the information available regardless of whether the prescriber is physically present in the same room as the patient.

In the end, and regardless of the reasons, Ryan Haight continues to be good law, meaning that it is enforceable against prescribing health care practitioners. Despite an apparent lack of actual enforcement (the last case against a physician to enforce Ryan Haight was in July of 2011), the DEA technically can choose to enforce Ryan Haight at any time. Prescribers should therefore be cautious and understand that remote prescribing of controlled substances, even within the confines of a state law, still could be considered a violation of federal law with penalties including prison, fines, and temporary or permanent loss of the prescriber’s DEA Registration. Health care providers contemplating the prescribing of any controlled substances through telehealth / telemedicine can benefit from doing diligence with the support of legal counsel to fully understand the potential impacts of Ryan Haight, relevant state laws, and the potential risk involved in such a venture before proceeding.

One of the challenges to increasing Medicare coverage of telehealth services is amending the statutory language in the Social Security Act (42 U.S.C. § 1395m) to remove geographic and other limitations. The Congressional Budget and Impoundment Control Act of 1974 requires the Congressional Budget Office (“CBO”) to provide cost estimates of proposed legislation. These CBO scoring reports provide estimates on the spending and revenues associated with legislation, generally over the window of 10 years beyond the effective date of the legislation. Therefore, budgetary effects beyond the 10 year window from legislation (for example, aimed at preventing longer term health costs) would not be taken into account as part of the CBO scoring process. This limitation in the CBO scoring process is seen by proponents of expanding Medicare coverage of telehealth services as a significant inhibitor to passing transformative legislation because the CBO scores reflects the initial uptick in costs to the program from access to services without incorporating the total savings projected over the longer term of an individual’s lifespan.

A bipartisan group of senators introduced a bill (Preventive Health Savings Act, S. 2164) in November of 2017, that would affect how the CBO analyzes legislation related to disease prevention, which could have a positive impact on the CBO scoring expansion of Medicare coverage of telehealth services and affect the ability to move changes through the legislative process. A nearly identical bill (H.R. 2953) was introduced in the House of Representatives in the summer of 2017, the status of which is still pending.

The Preventive Health Savings Act would allow Congress to request a proposal be reviewed by the CBO for budgetary savings from preventive health services, beyond the existing 10 year window from legislation. As proposed in the bill, the CBO would be required to score proposals based on reviewing publicly available scientific studies of preventive health and preventive health services, which the legislation broadly defines as “an action that focuses on the health of the public, individuals and defined populations in order to protect, promote, and maintain health and wellness and prevent disease, disability, and premature death.” The bill also would allow the CBO to review the budget savings for preventive health services extending into an additional two decades beyond the traditional 10 year budget window beyond legislation.

Why is this important to telehealth? This bill, if passed into law, would require CBO to more accurately measure the benefits of preventive care. The U.S. incurs significant, but avoidable, costs related to the treatment of certain diseases and chronic care services, so preventive tools and services are beneficial as a means toward lowering such costs. Telehealth services are well suited to be used as tools that connect patients to their health care providers in order to prevent diseases from occurring or to help maintain health conditions in order to prevent existing conditions from worsening. However, the savings to an individual’s health care costs that are associated with disease prevention would not be measured to their full effect in a shorter term window, as compared to the longer term (i.e., 30 year) window that these bills propose.

Telehealth services offer health care providers the opportunity and the capability to reach broader Medicare beneficiary populations and to serve as disease prevention tools for these populations. Proponents of the bills believe that passage would allow the CBO to more accurately measure the financial savings associated with any legislation that is intended to broaden access by Medicare beneficiaries to telehealth services.

Our colleague Ebunola Aniyikaiye at Epstein Becker Green has a post on the Health Law Advisor blog that will be of interest to our readers: “A Case for an Exception to the FCC Rule: Vulnerable Populations and Telemedicine.”

Following is an excerpt:

On December 14, the Federal Communications Commission (FCC) voted to remove regulations that prohibit providers from blocking websites or charging for high quality service to access specific content. Many worry that allowing telecommunications companies to favor certain businesses will cause problems within the health care industry. Specifically, concerns have risen about the effect of the ruling on the progress of telemedicine and the role it plays in access to care. …

Read the full post here.

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.”