I’m pleased to announce that we’ve released the 2019 update of our Telemental Health Laws survey. Now in its fourth year, the survey covers state telehealth laws, regulations, and policies within mental health and is available as a complimentary app for iPhoneiPad, and Android devices.

Please see our full announcement detailing milestones achieved in 2019, current barriers, and opportunities for 2020 and beyond: “Epstein Becker Green Finds Telehealth Services Are Increasingly Accessible to Mental Health Professionals Despite Legislative Barriers.”

Also see our Telemental Health Laws: Overview, which goes into greater depth on our findings from the survey.

As I state in our release, we are excited to see telehealth services more widely accepted at the state and federal level. Telehealth is a viable and efficient method of care for patients who require quality treatment that may not be close by. It also gives providers an opportunity to share their services and expertise with underserved segments and geographies they couldn’t serve otherwise.

On February 14, 2019, the Centers for Medicare & Medicaid Services (“CMS”) announced the Emergency Triage, Treatment and Transport reimbursement model (the “ET3 Model”), a demonstration project that aims to provide improved flexibility to ambulance crews addressing 911-initiated emergency calls for Medicare beneficiaries.

CMS plans to release its Request for Applications (“RFA”) to solicit participation in the ET3 Model from Medicare-enrolled ambulance providers and suppliers in the summer of 2019. The ET3 Model start date is anticipated for January 2020 for those selected to participate under the RFA. It will have a five-year performance period.

Currently, Medicare will reimburse for emergency ground ambulance services when individuals are transported to certain covered destinations, such as an emergency department (“ED”) in a hospital. The current reimbursement model, according to CMS, incentivizes ambulance crews to transport most Medicare beneficiaries who call 911 to a hospital ED—even when a lower “acuity”[1] health care destination may be more appropriate for the patient and for costs.

This incentive to transport most Medicare patients to hospital EDs can result in two issues. First, hospitals are expensive destinations; health care costs (for both patients and the government/taxpayers) are much higher for hospital ED visits than for visits to other health care destinations. In fact, CMS notes that “an earlier White Paper by the U.S. Departments of Health and Human Services and Transportation found” savings potential of $560 million per year by transporting Medicare beneficiaries to “doctors’ offices” when appropriate instead of hospital EDs.[2] Second, hospital EDs are clogged with patient cases that can divert important resources necessary to efficiently treat higher-acuity cases.

The ET3 Model intends to combat these issues by reducing expenditures and enhancing the quality of patient care. According to the February 14, 2019 press release, the model aims to ensure the “most appropriate level of care at the right time and place with the potential for lower out-of-pocket costs.” The model will reimburse participating ambulance suppliers and providers for:

  1. transporting an Medicare beneficiary to a hospital ED or other destination currently covered under Medicare regulations;
  2. transporting the beneficiary to an alternative destination, such as an urgent care clinic, a primary care doctor’s or other physician’s office, or a behavioral health center; and
  3. providing treatment to the beneficiary with a qualified health care practitioner either on the scene (e.g., a nurse practitioner as part of the EMS crew) or via telehealth, will be paid to participating providers and suppliers as a telehealth originating site.[3]

As a result of these reimbursement options, the ET3 Model targets the reduction of avoidable transports to hospital EDs (or transports to any destination, since on-scene or telehealth-delivered care may be reimbursed), which would in turn decrease unnecessary hospitalizations following those transports.

The ET3 Model also encourages a medical triage component delivered by a “health care professional” for low acuity 911 calls.[4] Under the ET3 Model, after a 911 call is received, the dispatcher either (1) initiates an ambulance service immediately or (2) routes the caller to a health care professional, who discusses health concerns with the individual and determines whether an ambulance should even be initiated (e.g., or whether the problem may be treated using telehealth). By triaging these calls, the ET3 Model seeks to improve efficiency in the EMS system so that professionals are able to more readily respond to and focus on higher-acuity cases, such as strokes, heart attacks, and serious physical trauma. By implementing these medical triage lines, applying local governments and other entities that operate or have authority over 911 dispatches in geographic regions where ambulance providers and suppliers have been selected to participate in the ET3 Model may receive “cooperative agreement funding” from CMS.[5]

As discussed above, the ET3 Model will be open to Medicare-enrolled ambulance providers and suppliers. Although the ET3 Model proposes to pay for telehealth and in-person treatment performed by participating ambulance providers and suppliers, the question of who will be coordinating these services is not yet contemplated. CMS has noted that ambulance providers and suppliers without qualified telehealth practitioners may wish to “seek opportunities for partnership” in preparation for the RFA release in the summer of 2019.[6]

 

[1] “Acuity” is essentially the level or intensity of care required to treat a patient.

[2] Centers for Medicare & Medicaid Services, Webinar: Emergency Triage, Treat, and Transport (ET3) Model – Overview, Slide 7 (Last updated March 21, 2019), available at https://innovation.cms.gov/resources/et3-overview.html.

[3] Participating EMS companies should be prepared to adhere to documentation rules if providing reimbursable treatment on scene or via telehealth.

[4] Centers for Medicare & Medicaid Services, Webinar: Emergency Triage, Treat, and Transport (ET3) Model – Overview, Slide 10 (Last updated March 21, 2019), available at https://innovation.cms.gov/resources/et3-overview.html.

[5] In Fall 2019 after ET3 Model participants have been selected and announced, CMS “anticipates issuing a Notice of Funding Opportunity (NOFO) . . . for up to 40 two-year cooperative agreements” for local governments and other entities to implement medical triage lines. See Centers for Medicare & Medicaid Services, Emergency Triage, Treat, and Transport (ET3) Model (Last updated March 21, 2019), available at https://innovation.cms.gov/initiatives/et3/.

[6] Centers for Medicare & Medicaid Services, Webinar: Emergency Triage, Treat, and Transport (ET3) Model – Overview, Slide 22 (Last updated March 21, 2019), available at https://innovation.cms.gov/resources/et3-overview.html.

The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a pharmaceutical manufacturer could temporarily loan a limited-functionality smartphone to financially needy patients enrolled in federal health care programs. OIG concluded that the proposed arrangement could violate federal health care fraud laws but OIG would not impose civil monetary penalties or administrative sanctions in light of the purpose of the arrangement and certain safeguards in place. This Advisory Opinion related to the promotion of remote patient monitoring and is useful to telehealth providers and other pharmaceutical manufacturers to evaluate how OIG might analyze similar arrangements.

The FDA recently approved a digital medicine version of the antipsychotic drug that, once ingested, gives off a signal detectable by a wearable sensor (a “Patch”) on a patient’s abdomen. The wearable tracks patient adherence to the medication regimen and transmits this data through an App on the patient’s smartphone.

Under the arrangement, in order to access and use the App, the pharmaceutical company would loan a smartphone to patients who have a prescription for the digital medicine drug, do not already have a smartphone, and have an annual income below a specific percentage of the Federal poverty level. The offer would not be advertised to patients and prescribers would not receive any financial benefit for prescribing the digital medicine drug or for helping patients participate in the program. The smartphone would come preloaded with the App and only have the ability to make domestic telephone calls but no other capabilities. Patients would have the loaner smartphone for no more than two 12-week periods.

OIG determined that because patients would receive something of value from receipt of the smartphone, the patients would receive a form of remuneration. Therefore, the OIG examined the arrangement under the Civil Monetary Penalties Law (“CMPL”). OIG determined that the arrangement would implicate the Beneficiary Inducement of the CMPL because the provision of the loaner smartphone may influence a patient to continue to receive care from the particular prescriber. Similarly, the patient may believe he or she must continue to use the specialty pharmacy to obtain the digital medicine drug if the patient uses the loaner smartphone.

However, OIG ultimately determined that the arrangement would satisfy the criteria under the CMPL’s Promote Access to Care Exception and not subject the pharmaceutical company to administrative sanctions under the AKS statute for the following reasons:

  • The loaner smartphone would improve a patient’s ability to both properly use and access the full scope of the benefits of the digital medicine drug.
  • Provision of the loaner smartphone to low-income patients would also pose a low risk of harm to the government, as it would be unlikely to interfere with clinical decision-making.
  • The arrangement is not likely to increase costs to federal health care programs or beneficiaries through overutilization or inappropriate utilization.
  • Patients would be unlikely to request the digital medicine drug for the sake of obtaining the loaner smartphone given that the program would not be advertised to patients.
  • The arrangement does not pose patient safety or quality-of-care concerns.
  • Provision of the loaner smartphone would not influence a person to select the digital medicine drug.

OIG also commented on what type of arrangement it would not give the same discretionary approval. If the smartphone had additional functionality, such as access to an internet browser or a camera, or the ability to add other apps, OIG would very likely conclude that the arrangement would not meet the Promote Access to Care Exception. OIG explained that additional smartphone capabilities are problematic because they would relieve patients from the need to purchase their own smartphones or pay for a smartphone contract.

In light of the safeguards in place, OIG concluded that the pharmaceutical company would not be subject to administrative sanctions under the CMPL and AKS in connection with the loaner smartphone program. Although this opinion is useful for other providers and suppliers that have or intend to have similar patient monitoring arrangements in place, the advisory opinion only applies to the particular arrangement.

Drug and device manufacturers that operate patient assistant programs and providers that provide care to patients enrolled in federal health care programs through digital devices must carefully scrutinize their own arrangement to ensure it does not violate federal health care fraud laws. However, this opinion provides insight into OIG’s rationale with respect to such telehealth arrangements. It is clear that a carefully structured arrangement that improves patient safety and quality of care and has safeguards in place to guard against fraud and abuse may be deemed permissible under the CMPL and AKS.

The telehealth industry has experienced constant developments in the regulatory landscape at both the federal and state level over the past several years, and we are confident these changes will continue into 2019 as the utilization of telehealth services continues to evolve and mature. A notable area of activity is how regulators are approaching the telehealth industry, in particular remote prescribing applications of this platform.

On the federal level, we should expect to see promulgation of regulations by the U.S. Drug Enforcement Administration outlining the special registration exception as mandated by the SUPPORT Act passed in 2018, allowing a pathway for health care providers to prescribe controlled substances through telemedicine, as detailed in our prior post.

On the state level, as telehealth becomes a mainstream mode of health care delivery, we are seeing states attempt to legislate telehealth services in more targeted, and potentially contentious, areas of health care.  For example, the ability to remotely prescribe abortion drugs or medical marijuana are some of these areas:

  • Kansas legislators passed the “Kansas Telemedicine Act (House Bill No. 2028), which includes a provision explicitly prohibiting the delivery of any abortion procedure ordered via telemedicine. The prescription of certain drugs would be involved in such a procedure. The Kansas legislature had attempted in prior bills to ban abortions conducted through telemedicine. However, in a recent legal challenge to the prohibition, on December 31, 2018 a state judge issued a ruling which struck down the prohibition of telemedicine abortions within HB 2028.
  • Michigan legislators passed Senate Bill 1198 (which was vetoed by the Governor) to extend a law passed in 2012 prohibiting abortion procedures ordered via telemedicine. The original 2012 law, which was set to expire after December 31, 2018, prohibited physicians from diagnosing and prescribing drugs for abortion unless the physician performed a physical examination on the patient. The 2018 law would have made this prohibition a permanent law.
  • In New Mexico, Senate Bill 406, revises the state’s Lynn and Erin Compassionate Use Act, expanding access to medical marijuana. This bill increases the number of “debilitating medical conditions” qualifying access to medical marijuana. The bill also incorporates a definition of telemedicine into the proposed statute and allows the issuance of medical marijuana identification cards pursuant to diagnoses of “debilitating medical conditions” made in person or via telemedicine. This in effect would expressly allow remote prescribing of medical marijuana based upon telemedicine encounters.
  • In Washington, Senate Bill 5498 revises the medical marijuana laws to expressly accommodate telemedicine examinations in the remote prescribing of medical marijuana. However, this bill only allows for the renewal of medical marijuana prescriptions based upon telemedicine examinations. This bill keeps in place the state’s requirement of an in-person physical examination for initial access to medical marijuana. Furthermore, this bill makes available this telemedicine encounter option only to patients that would likely result in severe hardship due to the patient’s physical or emotional condition.

Whether or not these move forward this year, these instances are nonetheless an indicator that telehealth is maturing and becoming more ingrained in the discussion of modes of health care delivery.

The SUPPORT for Patients and Communities Act (“the Act” or “the SUPPORT Act”), signed into law by President Trump on October 24, 2018, is intended to combat the growing opioid crisis in the United States. The Act aims at preventing opioid addiction and misuse and enhancing access to care for those who have substance use disorders.

A key aspect of the Act is the expanded Medicare coverage of telehealth services to beneficiaries in their home (see Section 2001 of the Act). Currently, and historically, Medicare has restricted coverage of telehealth services to beneficiaries who reside within certain geographic rural areas and who seek such services at specific “originating sites” (patient beneficiary’s home is not included in the current Medicare definition for “originating site”). The Act amends 42 U.S.C. § 1395m(m) to eliminate these coverage restrictions for “an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary [of Health and Human Services].” With this amendment in place, health care providers may now be reimbursed for providing eligible substance use disorder services to Medicare beneficiaries in their homes via telehealth. Although the Act does not provide for any “facility fee” reimbursement for telehealth services provided to beneficiaries in their homes, the Act requires reimbursement be provided to physicians and other health care practitioners furnishing these services at the same rate as they would otherwise receive if providing the same services in-person.

It is important to note that while Section 2001 of the Act takes effect on July 1, 2019, it authorizes the Secretary of the U.S. Department of Health & Human Services (“Secretary”) to implement these amendments immediately by creating a final interim rule.  The Act also mandates that the Secretary report on the impact of this legislation on: (1) the health care utilization (and in particular, emergency department visits) related to substance use, and (2) “health outcomes related to substance use disorders,” including opioid overdose deaths. The Act provides $3 million to the Centers for Medicare & Medicaid Program Management Account in order to carry out these reporting requirements, which must be completed within five years.

Another key aspect of the Act mandates that the U.S. Attorney General (“Attorney General”) promulgate final regulations that specify (1) “the limited circumstances in which a special registration under this subsection may be issued” and (2) “the procedure for obtaining a special registration.” Under 21 U.S.C. 831(h), as amended by The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”), this special registration would allow health care providers to prescribe controlled substances via telemedicine when legitimately necessary, including when an in-person evaluation is not possible. As discussed in one of our recent TechHealth Perspectives blog posts, despite the statutory mandate in the Ryan Haight Act passed more than eight years ago, the Attorney General has not yet issued any regulations or guidance on how to obtain this special registration. The Drug Enforcement Administration (“DEA”), the federal agency delegated authority to promulgate these regulations by the Attorney General, has also not promulgated any regulation or other guidance addressing special registration. The SUPPORT Act gives the Attorney General until October 24, 2019, to promulgate its final regulations on this matter.

Epstein Becker & Green plans to discuss the Act’s numerous provisions in greater detail in future Client Alerts.

The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)) (the “Ryan Haight Act” or “Act”) expanded the federal Controlled Substances Act to define appropriate internet usage in the dispensing and prescribing of schedule drugs, and in doing so effectively banned the issuance of prescriptions via telemedicine services for any controlled substances unless the ordering physician has conducted at least one in-person evaluation of the patient. The Act includes multiple exceptions that permit prescribing of controlled substances without conducting an in-person evaluation, the most relevant to the practice of telemedicine being the mandate that the Drug Enforcement Administration (“DEA”) or other federal agency establish rules for a “Special Registration” to be utilized by health care providers. However, despite the statutory mandate, since the 2008 passing of the Act neither the DEA nor any other federal agency has promulgated any regulation or other guidance regarding the development and implementation of such a Special Registration process.

Several previous TechHealth Perspectives blog posts have highlighted the pressures imposed from Congress on the DEA to promulgate the Special Registration process in the wake of the opioid crisis and the recent passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), which seeks to address the lack of regulatory guidance regarding the Special Registration exception to the Ryan Haight Act.  Ironically, the Bill would require the DEA to promulgate rules that are already required under the Ryan Haight Act to allow health care providers to apply for a Special Registration.

In the interim, state legislatures have started passing their own laws to address the issue of remote prescribing of controlled substances by telemedicine providers. State remote prescribing legislation varies widely among the states that have enacted such provisions, but generally fits into one of three categories:

Category I—Remote Prescribing is Allowed. Many states have not regulated the remote prescribing of controlled substances any differently than how the state has regulated in-person prescribing practices, or states have placed very minimal, added responsibilities on telemedicine providers seeking to do remote prescribing of controlled substances, which primarily are intended to ensure that the standard of care provided in the telemedicine delivery setting sufficiently mirrors the standard of care provided in the traditional in-person delivery setting. Examples of states that have taken this route include Arizona, Kentucky, Maine, Minnesota, Missouri, Tennessee, and Vermont.

Category II—Remote Prescribing is Prohibited. A handful of states have completely prohibited the remote prescribing of controlled substances or only permit it to occur in rare instances. Connecticut and Georgia (citation available just past verification page) are examples of two states that have adopted this approach.

Category III—Remote Prescribing is Allowed, But Additional Burdens and Barriers Are Placed on Prescribing Providers. Several states, including New Jersey, North Dakota, Oklahoma, and South Carolina, require at least one in-person appointment before a health care provider can remotely prescribe controlled substances or scheduled narcotics / medications to their patients. While these states may allow for the remote prescribing of controlled substances, there may be limits on prescribing activities, including limits on the types of controlled substances that can be remotely prescribed (and expressly prohibiting the prescribing of certain controlled substances entirely, such as opioids and certain schedule narcotics).

Regardless of which category a state may fall into, many of these states’ laws would be in direct conflict with the Special Registration exception under the Act, if it is ever formulated. That is, many states either prohibit the remote prescribing of controlled substances without an initial in-person consult, or impose more stringent conditions on remote prescribing than what is mandated under current federal law. The question is whether federal law would preempt any state law that is inconsistent with the Special Registration exception and would prohibit remote prescribing without an in-person examination even if the health care provider holds a Special Registration from the federal government.

Congress expressly retained supremacy and preemption through provisions of the Controlled Substances Act (21 U.S.C. § 903): “[n]o provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.” The legislative intent is clear that upon the passing of the Controlled Substances Act, Congress anticipated federal and state conflicts of law and expressly directed that federal law would control. However, the drafting yields some authority to the states and is somewhat ambiguous on relevant points.

Thus, states may also regulate remote prescribing and many have taken the opportunity to do so. If the DEA or any other federal agency promulgate rules that potentially could affect any of the existing state laws pertaining to remote prescribing, the supremacy provision  in the Controlled Substances Act is sufficiently vague such that states could craft creative legal arguments providing that the federal and the state laws can consistently stand together. Currently, no entity (federal or state) has challenged any of the existing state laws as conflicting with the Ryan Haight Act or the exceptions for remote prescribing without an initial in-person examination. However, should such an action be filed, federal preemption could overrule any inconsistent state laws, rules, or regulations.

Recently, we have seen some indicia of federal preemption in the telehealth arena with the Department of Veterans Affairs asserting dominance over any state regulation and oversight of telemedicine services with the promulgation of recent regulation (38 C.F.R. § 17.417) which states in no uncertain terms that the federal rule overrides any conflicting state laws. Moreover, the notice and comments from the Department of Veterans Affairs strongly invoke federalism in this area.

Ultimately, federal law could preempt the various state laws that completely prohibit telehealth prescribing, as well as those state laws that have put in place barriers to remote prescribing that are inconsistent with the Ryan Haight Act. Upon the promulgation of the Special Registration process, if and when it may occur, each state will have to assess and address any inconsistencies with federal law in the area of remote prescribing. Of course, while the provisions in the Ryan Haight Act addressing Special Registration do not have limitations on what kind of controlled substances could be remotely prescribed without an in-person examination under the exception, the Special Registration could incorporate limitations on the type of controlled substances that can be remotely prescribed without an in-person examination (similar to current requirements in a number of states).

In the end, the DEA (or whatever other federal agency decides to address the issue of remote prescribing) will need to find a balance when developing the Special Registration process, as there are legitimate concerns surrounding how to address the opioid crisis which is at the forefront of ongoing public health discussions. The current federal stance related to the opioid abuse in this country may prompt federal regulators to turn a blind eye to any conflicting state law or, in the alternative, it may prompt the federal regulators to exercise the power to promote access to needed treatment. The federal government may have the right to preempt and enforce against state laws inconsistent with the Ryan Haight Act; however, most state laws are generally aligned with the public policy intent behind the Ryan Haight Act. Below are additional resources which will be helpful in attaining a broader understanding of the current public information on both the state and federal level concerning the Opioid Crisis:

Rebecca Francis, a Summer Associate (not admitted to the practice of law) in the firm’s Houston Office, contributed significantly to the preparation of this post.

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.