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.

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.

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.”

Updates to OIG FY 2017 Work Plan

The United States Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) recently updated its FY 2017 Work Plan. Traditionally, OIG’s annual Work Plan has given health care providers a preview of OIG’s enforcement priorities. With the OIG now making updates to its Work Plan on a monthly basis, providers stand to gain even more insight into how the focus of OIG is constantly shifting in order to assist in the identification of significant compliance risk areas.

In this most recent set of updates to the FY 2017 Work Plan, OIG announced that it will conduct a review of Medicare claims paid for telehealth services in FY 2017. Specifically, OIG is interested in reviewing claims for telehealth services provided at “distant sites” (i.e., the location of the provider of the telehealth service) that do not correspond with claims from an “originating site” (i.e., the location of the patient). By undertaking this review, presumably OIG seeks to verify that providers of telehealth services are: (1) appropriately rendering these services to Medicare beneficiaries based on current reimbursement rules under Medicare for provision of telehealth services (i.e., the beneficiary is at a valid originating site when receiving the telehealth service, which under current Medicare rules does not include a beneficiary’s home), and (2) not submitting fraudulent claims for telehealth services (i.e., services delivered outside of Medicare’s coverage and reimbursement scope). OIG’s review of these claims may demonstrate the need to update Medicare’s outdated coverage and reimbursement provisions for telehealth services.

Medicare’s Current Coverage of and Reimbursement for Telehealth Services

Compared to ever-expanding coverage of and reimbursement for telehealth services in individual states, as well as the private insurance market, Medicare Part B beneficiaries currently have limited access to telehealth services due to the following restrictions:

  1. Medicare beneficiaries only have access to telehealth services transmitted using an “interactive 2-way telecommunications system (with real-time audio and video).” This definition excludes three frequently used modalities used by providers to deliver telehealth services: (a) store-and-forward technology (with the limited exceptions of CMS demonstration projects ongoing in Alaska and Hawaii), (b) remote patient monitoring (“RPM”) services, and (c) mobile health / wearable technology.
  2. Medicare confines telehealth coverage to “rural health professional shortage area[s].” This geographic restriction is federally defined.
  3. Medicare beneficiaries only may receive telehealth services while physically situated at one of eight “originating site[s],” none of which include the patient’s home—those living in geographically-restricted areas are still obligated to access a medical originating site in order to activate Medicare coverage.
  4. Only eight types of practitioners may deliver the telehealth services to Medicare beneficiaries, and must do so from a qualified “distant site.”
  5. The Centers for Medicare & Medicaid Services (“CMS”) publishes a limited number of HCPCS and CPT codes for telehealth services, and while this universe of codes has gradually increased over time, most of these codes are geared towards reimbursement for behavioral health services delivered through telehealth.

Current Legislative Efforts in Congress

In recent years, federal lawmakers have been working to lessen the constraints on Medicare Part B coverage of and reimbursement for telehealth services.

In August 2016, HHS published a Report to Congress on “E-Health and Telemedicine.” In this report, HHS expressed its support for telehealth expansion and its importance in the health care industry: “[T]elehealth holds promise as a means of increasing access to care and improving health outcomes.” Congress has seemed to take note. In the 2017–2018 legislative session, four key bills have been introduced that, if passed, would improve coverage of and reimbursement for telehealth services under Medicare:

  • The CHRONIC Care Act of 2017 (S. 870) would make four key changes to Medicare: (1) provide coverage and reimbursement for RPM delivery of home kidney dialysis assessments; (2) provide nationwide coverage and reimbursement for “telestroke” consultations (not just those that occur in rural hospitals or other originating sites); (3) eliminate the geographic restriction of an originating site for Accountable Care Organization (“ACO”) beneficiaries, thus allowing patients to receive home telehealth services; and (4) allow Medicare Advantage plans to offer telehealth benefits in annual bid amounts, instead of using rebate dollars to pay for telehealth as a “supplemental service.” The CHRONIC Care Act recently received a favorable, budget neutral Congressional Budget Office (“CBO”) score—alleviating a traditionally difficult roadblock for telehealth legislation.
  • The Medicare Telehealth Parity Act of 2017 (H.R. 2550) would provide an incremental expansion of coverage for telehealth services under Medicare by expanding the number of acceptable geographic locations for telehealth coverage under three “phases.”
  • The CONNECT for Health Act of 2017 (H.R. 2556) includes provisions that would expand coverage and reimbursement of telehealth services for (1) ACO enrollees, (2) individuals receiving kidney dialysis therapy, (3) stroke patients, and (4) RPM services for beneficiaries needing chronic care and would lift restrictions on telehealth for mental health services.
  • The HEART Act (H.R. 2291) aims to increase Medicare coverage of telehealth services, including coverage and payment for store-and-forward services delivered to “any telehealth services that are furnished from a distant site, or to an originating site, that is a critical access hospital . . ., a rural health clinic . . ., or a sole community hospital” and for home-based monitoring of congestive heart failure and chronic obstructive pulmonary disease. These three bills have not yet been scored by the CBO.

While it remains to be seen whether any of these bills (or any others) will become law, the level of legislative activity still is promising—and particularly so in conjunction with HHS’s support for telehealth—that expansion of telehealth coverage and reimbursement under Medicare can make greater strides toward improving access to these services for Medicare beneficiaries.

Added to this, OIG’s recent updates to the FY 2017 Work Plan to include a review of telehealth reimbursement claims under Medicare may further accelerate this process if OIG identifies any pertinent potential risk areas related to provision of telehealth services.

This post was written with assistance from Matthew Sprankle, a 2017 Summer Associate at Epstein Becker Green.

Telehealth continues to be a hot topic of state and federal legislatures. Texas, for example, recently joined the rest of the states in no longer requiring initial in-person visits before being able to provide telehealth services.

The Texas legislature enacted the major telehealth bill SB 1107 on May 19, 2017, and the governor signed the bill into law shortly thereafter on May 27, 2017. As reported in our prior post, Texas had considered that, if passed, this telehealth bill would allow patient-physician relationships to be established via telemedicine without requiring an initial in-person visit. Prior guidance from Texas Medical Board required an in-person physician-patient interaction before a visit via telehealth, specifically in prescribing medication. The Texas Medical Board’s telemedicine FAQs are being revised as a result of this enacted law.

This law’s enactment would also effectively bring to an end the years long battle between a telehealth provider and Texas Medical Board. In 2015, a telehealth provider brought legal action against the Texas Medical Board and its telehealth restrictions. This litigation was twice stayed to allow for such a resolution to occur.

Additionally, the Federal Trade Commission was investigating the Texas Medical Board for possible antitrust violations due to its guidance that restricted the practice of telemedicine and telehealth in Texas. However, on June 21, 2017, the Federal Trade Commission announced that it will close its investigation into the Texas Medical Board as a result of the Texas legislatures enacting the law that overrode the board’s telehealth restrictions.

This Texas telehealth law is important because of the large telehealth market that Texas represents. The passage of this law removes the hurdle to allow telehealth providers to start operating or expand operations in the state with the second largest population in the nation.

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

What will the telehealth landscape look like under the Donald J. Trump Administration?

The Trump Administration is likely to drive telehealth advancement in a positive direction. For example, President Trump’s plan to reform the Veteran’s Affairs Department includes improved patient care through the use of telehealth technology. There are also some indications that the newly confirmed Secretary of the Department of Health and Human Services (“HHS”), Tom Price, is “telehealth friendly.” Recently, during the congressional confirmation hearings, Price mentioned a tele-stroke program in Georgia as a model of success, and he said he thought there were many things that can be done to mirror that kind of technological expansion. Price also said he is interested in promoting telehealth because it “holds great promise, particularly for rural areas experiencing physician shortages and for patients with limited mobility.” Moreover, Trump’s pick to be the next Administrator of the Centers for Medicare and Medicaid Services (“CMS”), Seema Verma, said in her recent congressional confirmation hearings that she wants to work with Congress to promote the use of telehealth technology. Specifically, she said, “telehealth can provide innovative means of making healthcare more flexible and patient-centric. Innovation within the telehealth space could help to expand access within rural and underserved areas.” Finally, Maureen Ohlhausen, the recently appointed acting chair of the Federal Trade Commission (“FTC”), has in the past spoken favorably regarding the potential of telehealth and has said that the current professional licensure system needs to be rethought given telehealth technology’s potential.

Despite the current focus in Congress on repealing and replacing the Affordable Care Act, telehealth legislation continues to gain traction and bipartisan support on the Hill. In February, a bipartisan group of 37 Senators sent a letter to Tom Price encouraging HHS to support telehealth and remote patient monitoring. Congress also has embraced telehealth advancement with a consistent stream of proposed legislation seeking to enhance the provision of telehealth services. Most recently, Rep. Joyce Beatty (OH-03) and Rep. Morgan Griffith (VA-09) reintroduced the Furthering Access to Stroke Telemedicine (“FAST”) Act that would expand access to stroke telemedicine (also called “telestroke”) treatment in Medicare. Congress also recently introduced HR 766 which would establish a pilot program to expand telehealth options under the Medicare program for individuals living in public housing. Additionally, Congress is poised to consider at least two bipartisan pieces of legislation focused on telehealth. The first is known as the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (“CHRONIC”) Care Act of 2016, which seeks to modernize Medicare payment policies focused on improving the management and treatment of chronic diseases using telehealth technologies. The second is known as the Creating Opportunities Now for Necessary and Effective Care Technologies (“CONNECT”) for Health Act, which seeks to mandate Medicare reimbursement for telehealth services (beyond the current, limited reimbursement framework). Finally, Senator Orrin Hatch (R-UT), the Chairperson of the Senate Finance Committee, recently released his “innovation agenda for the 115th Congress” which encourages the promotion of the “internet of things,” greater broadband investment, and increased device-to-device communication and cross-border data flows.

Continue Reading Telehealth Outlook Under the Trump Administration

Texas and Telehealth: New Bill Would Remove Toughest Hurdle For PractitionersIn recent years, Texas has served as ground zero for a number of the most contentious legal battles surrounding telehealth. This week, State Senator Charles Schwertner, the chairman of the Committee on Health and Human Services, submitted a bill signifying progress for telemedicine and telehealth providers looking to practice in the Lone Star State. The bill, S.B. 1107, would remove one of the toughest hurdles for telemedicine and telehealth practitioners – the face-to-face meeting requirement. Providers would be able to provide services to, and establish physician-patient relationships with, Texas residents through either a synchronous audio-visual interaction or via store-and-forward technology and an audio-only interaction, without ever having to meet the patient in real life. The bill would require the practitioner to use the relevant clinical information required to meet the same standard of care as practitioners providing in-person services.

The bill also would mean changes for the policies of the Texas Medical Board. The legislation signifies that the “telepresenter” requirement, mandating the presence of a healthcare professional when a patient initiates a video consultation, would be eliminated. In addition, the Texas Medical Board, along with the Texas Board of Nursing, the Texas Physician Assistant Board, and the Texas State Board of Pharmacy, would be required to adopt rules defining “valid” prescriptions for telemedicine visits. This would supersede the current, and defunct, policy against telemedicine prescribing, although prescribing abortion drugs would still be prohibited.

The new bill follows the stay recently placed on the litigation between the Texas Medical Board and telehealth company Teladoc. The dispute arose in 2015 when the Texas Medical Board ruled that Texas physicians were prohibited from prescribing to patients without a face-to-face visit. In response, Teladoc filed an antitrust suit and obtained an injunction against enforcement of the rule. The Texas Medical Board then revised the rule, requiring a face-to-face evaluation to establish a physician-patient relationship. Teladoc again filed suit and obtained another injunction. Although the Texas Medical Board filed an appeal, it backed down in October 2016 after the U.S. Department of Justice and the Federal Trade Commission expressed support for Teladoc through amicus briefs. The Texas Medical Board and Teladoc are now rumored to be discussing a settlement.

Telemedicine has made great recent strides in terms of greater acceptance and deployment.  That said, a lot of work still needs to be done. Two recent surveys, one of tech savvy consumers and another of health care stakeholders make that case.

The first survey was done on behalf of a consumer health engagement company.  It makes for sobering reading. The survey polled 500 insured consumers who are also users of mobile health applications.  Some interesting findings:

  • Almost 40% have not heard of telemedicine.
  • 42% who have not used telemedicine and prefer an in-person physician visit instead.
  • Mobile Healthcare28% don’t know when it is appropriate to use telemedicine.
  • 14% don’t trust a telemedicine provider to diagnose and/or treat.
  • 14% are not sure if telemedicine services are covered by health insurance

Survey participants were also asked for which services they would consider using telemedicine:

  • 44% for follow-up care for acute illness.
  • 44% for symptom tracking/diagnosis.
  • 44% for medication management/prescription  renewal.
  • 34% for follow-up care for a chronic condition.
  • 31% for remote monitoring of vital signs.
  • 24% for behavioral/mental health.

There was better news in the survey. First, 55 percent of consumers who have access to telemedicine have used it.  Second, and more interestingly, 93 percent who have used telemedicine conclude that it lowered health care costs.  While it is only one survey, I think the results clearly show a consumer education and exposure gap regarding telemedicine that needs to be addressed.  Remember, the survey respondents were tech savvy consumers, and the high numbers of those unaware of telemedicine should be a call to action to those of us who believe in the viability of proper telemedicine.

The second recent survey I would like to discuss was conducted by a leading enterprise software company. The survey polled health care executives and health care clinicians regarding their views on the challenges and objectives of telemedicine programs.  The survey paints a compelling and encouraging picture.  Amongst the highlights:

  • Almost 66% of survey participants indicate that telemedicine is their top priority or one of the highest priorities for their healthcare organizations.
  • The top three telemedicine objectives are:
    • Improved patient outcomes.
    • Improved patient convenience.
    • Increasing patient engagement and satisfaction.
  • Among the most significant obstacles to telemedicine success are reimbursement, lack of integration between telemedicine and EMR systems, and determining ROI.
  • Maturity of telemedicine programs varies widely among service lines and care settings. Those settings requiring highly specialized treatment are more mature than those requiring generalized treatment.
  • Approximately a quarter of those surveyed report that ultimate accountability for telemedicine program success rests with a C-level executive.
    • Another 22% report that accountability is at the vice president level.
  • 75% report that the source of the telemedicine platform is primarily purchased or licensed from a vendor.

Based on this survey, the news from health care stakeholders is quite promising for the future of  telemedicine.  Most respondents view telemedicine as one of their top priorities and more than half show their commitment by making C-level executives or vice presidents accountable for telemedicine program success.

Ultimately, I think the two surveys raise interesting and conflicting perspectives.  On the one hand, many health care stakeholders appear all in or thereabouts regarding telemedicine despite significant obstacles such as reimbursement. On the other, there is an unsettling consumer exposure/education gap with significant segments of consumers unaware of telemedicine.  In the final analysis, consumer awareness and education will need to improve significantly to better drive telemedicine demand and growth.