Telehealth and Telemedicine

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.”

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.

Epstein Becker Green released an Appendix to its “50-State Survey of Telemental/Telebehavioral Health (2016)” with new and updated analysis on the laws, regulations and regulatory policies affecting the practice of telemental/telebehavioral health in all 50 states and the District of Columbia. Since the Survey was released in 2016, states have been incredibly active in their legislative efforts with respect to the provision of telehealth services. As a result, EBG again conducted extensive research to share relevant changes with providers and consumers who are navigating this complex legal and regulatory landscape.

To access the 2017 Appendix, click here. To access the 2016 50-State Survey of Telemental/Telebehavioral Health, click here.

Pursuant to the 21st Century Cures Act of 2016, Congress mandated the Medicare Payment Advisory Commission (“MedPAC”) to provide a report to Congress by March 15, 2018, in which MedPAC has been asked to answer the following questions:

  1. Under the Medicare Fee-for-Service program (Parts A and B), what is the current coverage of telehealth services?
  2. Currently, what coverage do commercial health plans offer for telehealth services?
  3. In what ways can the Medicare Fee-for-Service program adopt some or all the telehealth service coverage presently found in commercial health plans?

Earlier this month, at the MedPAC public meeting, the Commission presented a general summary regarding the first of these three questions, specifically the Medicare Fee-for-Service program’s current coverage of telehealth services. MedPAC examined four different aspects of the Medicare Fee-for-Service program that currently address coverage of telehealth services: (1) the Medicare Physician Fee Schedule; (2) other Fee-for-Service payment models within the Medicare program (e.g., inpatient / outpatient hospital services); (3) the Medicare Advantage program; and (4) the Centers for Medicare & Medicaid Innovation initiatives.

Medicare Physician Fee Schedule (“PFS”). Presently, Medicare PFS coverage of telehealth services is the most constrained because of the concern of overutilization from volume incentive. Unlike other fee-for-service models utilized by the Medicare program (e.g., MA program, CMMI initiatives) there is no associated cost risk to providers who utilize telehealth services under the Medicare PFS (i.e., no fixed payment, no cap constraints); therefore, the Medicare PFS contains comparatively strict parameters that must be met in order for Medicare to provide reimbursement for telehealth services. For example, the Medicare PFS only covers telehealth services that originate in rural areas and that are performed at one of several specific types of facilities. Furthermore, the Medicare PFS only will cover two types of telehealth modalities, two-way video (synchronous), and store-and-forward (asynchronous) technology, and the latter of these only if services are provided to Medicare beneficiaries residing in Alaska or Hawaii. The Medicare PFS has designated telehealth FFS codes for limited physician services, including office visits, mental health services, substance abuse treatment, and pharmacy management services. Under the Medicare PFS telehealth services also may be included in larger fixed payments that resemble remote patient monitoring activities (e.g., transitional care management services, chronic care management services) as well as through bundled payments for such things as the 90-day global surgery bundle and payments for cardiac monitoring devices. Interestingly, because some of these services (despite being provided via telehealth modalities) are not part of the official Medicare PFS list of telehealth FFS codes, they are not constrained by the current Medicare PFS rules and requirements for provision of telehealth services (e.g., originating site rules).

Other Medicare Fee-For-Service (“FFS”) Payment Models. Within the Medicare program, various other FFS payment models exist for provision of services to beneficiaries, with respect to services including inpatient/outpatient hospital services, skilled nursing facilities (“SNFs”), inpatient rehabilitation facilities (“IRFs”), dialsysis facilities, and long-term acute care hospitals (“LTACHs”). In contrast to the Medicare PFS rules and requirements for provision of telehealth services, Medicare coverage of telehealth services under these other Medicare FFS payment models has been more flexible because both providers and health plans bear risk if the cost of a beneficiary encounter exceeds the fixed payment for that encounter. Under these Medicare FFS payment models, providers are incentivized to use telehealth services only if doing so would reduce the cost of providing the services. Although under most of these other Medicare FFS payment models, providers may include the costs associated with telehealth services costs on their annual cost reports as allowable costs, there are some exceptions to this general rule (specifically, home health agencies and hospice agencies) that may not include these costs on their annual cost reports.

Medicare Advantage (“MA”) Program. Under the MA program, payments to health plans are capitated and health plans must provide coverage for any telehealth services that are covered under the existing Medicare PFS, so as a result coverage for these services under the MA program also is constrained by the same PFS rules and regulations described above. However, by contrast, the MA program extends to these health plans the flexibility to finance coverage of additional telehealth services through a supplemental premium or their rebate dollars. Although the telehealth services offered by these health plans (as supplemental benefits) may not be built into the bids these health plans submit to the MA program, any savings from the health plans’ use of such services can be captured by the health plans in their required reporting to CMS. Similar to FFS, there is an incentive to use telehealth service if it reduces costs.

Center for Medicare and Medicaid Innovation (“CMMI”) Initiatives. Through the CMMI, selected pilot programs have been given waivers by CMS to incorporate the use of telehealth services beyond what is currently permitted through the Medicare PFS rules and regulations. For example, some accountable care organizations (“ACOs”), known as the “Next Generation ACOs”, have received CMMI waivers to use telehealth services in urban settings and/or beneficiaries’ homes (contrary to current Medicare PFS coverage rules and requirements). Other ACOs have received CMMI waivers allowing physicians to receive Medicare FFS payment rates for telehealth visits while the ACO remains at risk for beneficiaries’ total spending. Many of the telehealth initiatives made possible by these CMMI waivers have arguably created greater incentive for Medicare providers to utilize telehealth service if they can have the effect of curbing associated costs.

At the recent meeting MedPAC also reported, based on the limited data currently available, on beneficiary utilization of telehealth services under the Medicare PFS. According to MedPAC, in 2016 approximately 0.3 percent of all Medicare beneficiaries (for Part B) utilized telehealth services, amounting to approximately $27 million for just over 300,000 encounters in total. MedPAC noted that the most common telehealth services utilized by Part B beneficiaries in 2016 were basic office visits, mental health services, and follow-up care. Additionally, approximately 2,000 ESRD-related visits and 2,000 telestroke visits occurred in 2016. Although this utilization was comparatively low, MedPAC reported an increased use of telehealth services, mostly in subsequent nursing care, psychotherapy, and pharmacological management. According to MedPAC, between 2014 and 2016 the number of telehealth visits per 1,000 beneficiaries increased by approximately 79 percent, compared to an average 3 or 4 percent increase for all Medicare physician services within that same two-year period. Also, MedPAC noted that telehealth users were disproportionately dually eligible (for Medicare and Medicaid), located in rural areas, and dealing with chronic care conditions (e.g., mental health conditions, diabetes, chronic obstructive pulmonary disease).

MedPAC will continue its examination of telehealth services by addressing the latter two questions in the following two months, with the intention to review the entirety of its findings in January 2018 (prior to publishing the March 2018 report). Although MedPAC’s upcoming meetings most likely will focus (with respect to telehealth services) on its June 2016 report findings, the Commission hopefully will start to combine its current examination of telehealth services with its June 2016 recommendations to policymakers regarding telehealth (e.g., expanding Medicare PFS coverage of telehealth services).