TechHealth Perspectives

STRATEGY, ANALYSIS, AND COMMENTARY ON CURRENT AND NEW HEALTH TECHNOLOGIES

50-State Survey on Telemental Health Laws in the United States

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We are pleased to present our 50-State Survey of Telemental/Telebehavioral Health (2016), published by Telehealth practice at Epstein Becker Green.

Learn more about the survey here and download your complimentary copy here.  See our full announcement below:

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As Cyber-Counseling Booms, Complex Legal and Regulatory Issues Grow;
Survey Breaks New Ground in Tracking Related Laws

WASHINGTON, DC – May 11, 2016 –Epstein Becker Green (EBG), has released a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia. The “50-State Survey of Telemental/Telebehavioral Health (2016)” details the rapid growth of telemental health (mental health care delivered via interactive audio or video, computer programs, or mobile applications) and the increasingly complex legal issues associated with this trend.

Telemental/telebehavioral Health Survey
While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care. The survey was spearheaded by René Y. Quashie and Amy F. Lerman, both EBG Senior Counsel in the Health Care and Life Sciences practice in the firm’s Washington, DC, office.

“As telemental health care gains in popularity, it gives rise to a number of significant legal and regulatory issues, including privacy and security, follow-up care, emergency care, treatment of minors, and reimbursement, among other things,” said Quashie. “While some federal laws and regulations (such as HIPAA) apply, most of the issues involve state law, which has resulted in an inconsistent patchwork of laws and regulations that vary widely by state. And there are a number of states that don’t address telemental health specifically in their laws.”

Bridging the Care Gap

The survey begins with a report on the state of telemental health in 2016, highlighting its growing legitimacy (and acceptance by payers) as a treatment option, the barriers to delivery that persist, the high costs of care and prescription drugs, and insurance reimbursement parity issues.

Mental health care lends itself particularly well to remote delivery, since the provider usually need not lay hands on the patient to provide care. In addition, this method helps bridge the gap between the large numbers of Americans (about 60 million) experiencing mental illness and the significant shortage of qualified mental health care providers. Only 40 percent of Americans with mental illness report receiving treatment, and there is one mental health care provider for every 790 individuals.

The EBG survey also reports that new technologies are driving the boom in telemental health, with a significant increase in mobile applications related to mental health (now almost 6 percent of all mobile health apps) and another 11 percent devoted to stress management. There is also a growing number of companies providing “text therapy” services, which allow users, for a flat-rate fee, to text chat with any number of licensed mental health providers.

“Accessing mental health care is a significant challenge for most Americans, with wait times to see a provider measured in weeks and months, rather than days. In addition to long wait times, distance, cost, and stigma present significant barriers to getting care. These are all challenges that telemedicine is uniquely equipped to solve,” said Dr. Ian Tong, Chief Medical Officer at Doctor On Demand.

Deep Dive into Legal Issues

The survey provides a detailed state-by-state analysis of legal issues related to telemental health, such as:

  • Definitions of “telehealth” or “telemedicine”
  • Licensure requirements
  • Governing bodies
  • Reimbursement and coverage issues
  • The establishment of the provider-patient relationship
  • Provider prescribing authority
  • Accepted modalities for delivery (e.g., telephone, video) to meet standards of care

There is also comprehensive data tracking telehealth legislation and rulemaking in progress for each state. Highlights include the following:

  • Psychiatrists, as practicing physicians, must comply with all the obligations that apply to physicians practicing telehealth generally. Very few states exempt mental health from physician requirements despite the fact that many psychiatrists never lay hands on patients. Ironically, Texas is one of the few states that explicitly carves out mental health services from other telehealth requirements.
  • In New York, psychologists may engage in telepractice so long as, among other things, they obtain informed consent from patients describing the benefits and risks of telepractice, and they conduct an initial assessment of each client to determine whether telepractice is appropriate.
  • In Delaware, an individual practicing “telepsychology” must conduct a risk-benefit analysis and document findings specific to issues such as whether a patient’s presenting problems and apparent condition are consistent with the use of telepsychology to the patient’s benefit, and whether the patient has sufficient knowledge and skills in the use of technology involved in rendering the service or can use a personal aid or assistive device to benefit from the service.
  • Kansas requires psychologists and social workers providing telemental health services to obtain the informed consent of the patient before services are provided.
  • In Maryland, physicians (psychiatrists) are required to develop a procedure to prevent access to data by unauthorized persons through password protection, encryption, or other means and to create a policy on how soon an individual can expect a response from the physician to questions or other requests included in transmission.

“As telemental health continues to grow and evolve, it will increasingly be viewed as a viable solution by clinicians, payers, and policymakers,” said Lerman. “At the same time, legal and regulatory issues will continue to proliferate. The survey breaks new ground for anyone navigating this multifaceted legal landscape.”

In addition to Mr. Quashie and Ms. Lerman, EBG attorneys Jonathan K. Hoerner, Bonnie I. Scott, James S. Tam, and Meghan F. Weinberg contributed to the survey.

Click here to download the survey.

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About Epstein Becker Green

Epstein Becker & Green, P.C., is a national law firm with a primary focus on health care and life sciences; employment, labor, and workforce management; and litigation and business disputes. Founded in 1973 as an industry-focused firm, Epstein Becker Green has decades of experience serving clients in health care, financial services, retail, hospitality, and technology, among other industries, representing entities from startups to Fortune 100 companies. Operating in offices throughout the U.S. and supporting clients in the U.S. and abroad, the firm’s attorneys are committed to uncompromising client service and legal excellence. For more information, visit www.ebglaw.com.

Recent Telemedicine Surveys Make for Interesting Reading

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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.

Telehealth Private Pay Reimbursement: The Real Numbers

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stethescopeAs you all know, the subject of telehealth reimbursement continues to vex the community. For example, Medicare lags far behind.  According to the Center for Telehealth and eHealth Law, Medicare reimbursed approximately $14 million total under its telehealth benefit for 2014.  This represents less than .0025 percent of the total Medicare reimbursed for services that year.  Medicaid is something of a mixed bag with the vast majority of states providing some coverage for telehealth, but many lagging in coverage and reimbursement for store-and-forward services and remote patient monitoring. Generally speaking, private payers have been ahead of the curve with the majority of states having parity laws in place requiring insurers to cover telehealth services in many circumstances.

One of the issues about which I am often asked is whether there is any data surrounding private pay reimbursement for telehealth.  A paper published by the Health Care Cost Institute provides some interesting data into telehealth billings.  The good news is that telehealth has extensive room in which to grow.  Among other issues, the paper analyzed one of the largest private claims databases to analyze trends in telehealth billings from 2009-2013.  Here are some key takeaways:

  • There were 6,506 claims for services related to telehealth submitted by primary care providers (compared to the 95.9 million non-telehealth claims).
  • Family practice providers submitted the most claims for telehealth followed by internal medicine.
  • Non-telehealth service reimbursements increased every year since 2009, from $57 to $61.
  • Average reimbursements for telehealth claims, however, declined substantially after 2011, decreasing from $68 to $38 in 2013—40% lower than that for non-telehealth claims in 2013.
  • California and New York had relatively small numbers of claims when analyzed against their large populations.
  • Among seven unique CPT codes for an office/outpatient visit for evaluation or management of a patient, average telehealth reimbursements were nearly the same or lower than the non-telehealth service for six of these procedures.
  • The most commonly diagnosed problem seen by primary care providers using telehealth (in descending order) were diabetes mellitus (almost 14% of all telehealth claims); depressive disorders; acute sinusitis; biopsy of the lymphatic structure; obstructive sleep apnea; bipolar disorder; and acute upper respiratory infections.

The paper notes that despite the increased use of telehealth, claims for telehealth services to private insurers are rare which the paper acknowledges could be due to the “considerable time lag in the translation of [state telehealth policies] into provider behaviors.  There is also some discussion suggesting that low telehealth billings may be due to confusion regarding the appropriate billing codes to use.

My sense is that a lot has changed since 2013, and that should a review be done today, telehealth billings would have significantly increased.  Nevertheless, the paper clearly confirms telehealth has plenty of room in which to grow.

The Telehealth Outlook for 2016

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International TelemedicineAs 2015 winds down, I think it is safe to say that it has been a whirlwind year in telehealth.  According to the National Conference of State Legislatures (NCSL), over 200 telehealth-related bills were introduced in 42 states.  The Federation of State Medical Boards (FSMB) has launched an interstate physician licensure compact that creates a new pathway to expedite physician licensure in multiple states.  Twelve states (with Wisconsin being the latest) have so far enacted the licensure compact.  Many states such as Colorado, Iowa, and Louisiana released regulations or policies that in my view took a more progressive approach to telehealth regulation.

Activity has not just been limited to the states.  Congress has introduced a number of telehealth-related bills such as the TELE-MED Act of 2015 which permits certain Medicare providers licensed in a state to provide telemedicine services to certain Medicare beneficiaries in a different state without having to be licensed in that state.  In addition, a number of reports, surveys, and white papers have been published on all aspects of telehealth.  After many false dawns, telehealth has truly arrived.  But many issues remain to be addressed.

Now we look forward to a new year.  What can we expect?  In addition to a continuation of what has occurred in 2015, there are a few other issues and/or trends that bear watching.  Here are a few:

The Rise of Compacts to Address Licensure Issues

The use of compacts to address licensure issues will continue to gain steam in 2016.  I have already mentioned FSMB’s interstate physician licensure compact.  As many of you know, nurses (RNs and LPNs/VNs) have long had a licensure compact in which a nurse who declares a compact state as his or her primary state of residence can practice (physically and remotely) in other compact states without having to obtain another license.  There are 25 states that are members of the nurse compact.

Other providers are getting in on the act.  Recently, the National Council of State Boards of Nursing, a non-profit association comprising 59 boards of nursing, released a draft compact for advanced practice registered nurses (e.g., nurse practitioners).  The draft APRN compact essentially follows the framework of the nurse licensure compact allowing APRNs to practice in any participating state with just once license. One interesting change in the draft APRN compact not included in the nurse compact is the requirement that states “implement procedures for considering the criminal history records of applicants for initial APRN licensure.”  I expect a number of states to enact the APRN compact in the coming years.

Note that psychologists, physical therapists, counselors, and EMS personnel are just a few of the provider groups that have considered or are considering compact models in some fashion.

Telehealth Accreditation

While there have been some accreditation programs that have touched on telehealth, I believe that 2016 will be the year in which telehealth accreditation takes on new significance.  Two recent examples highlight my point.  About a year ago, the American Telemedicine Association launched an accreditation program for online consultations in which ATA accredits organizations that provide online, real-time health services complying with certain standards.  Among the examples the ATA offers of what kind of the kind of organizations the program would accredit is an employer providing its employees with online, real-time telehealth services.

More recently, URAC, a longstanding accrediting organization, has launched its own telehealth accreditation program for providers involved in consultations with facilities, consumers, and other health care providers through televideo and other electronic methods.  URAC’s accreditation standards were developed by an expert panel that included health systems, hospitals, health plans, telemedicine companies, and academic medical centers.

The Voice of Large Employers

I believe 2016 will be the year large employers will be heard loud and clear in the telehealth regulatory debates that are sure to take place.  The fact is many Americans receive their health insurance through their employers.  And, according to the National Business Group on Health, 74 percent of large employers are expected to offer telehealth in 2016 compared to 48 percent in 2015.  Given the important role employers play in health care, and how telehealth is increasingly being used by employers, it is only logical that employers would ultimately play a significant role in our ongoing telehealth regulatory debate.

One group is leading the charge.  The ERISA Industry Committee (ERIC), the only nonprofit national association advocating solely for the employee benefit and compensation interests of the country’s largest employers, earlier this year launched a telehealth initiative to promote policies that facilitate access to telehealth for employees to have expanded access to health care services.  ERIC will be actively involved in the major telehealth discussions that occur next year both at the state and federal levels giving large employers a significant voice not usually heard from in telehealth regulatory circles.iStock_000062830618_Small

Wearable Market Poised for Breakout

As I have written before in previous blog posts, the healthcare wearables market is projected to significantly increase in the next few years. Generally speaking, wearables are devices (which usually include microchips or sensors) that, among other functions, collect data and track fitness and wellness. Market research is bullish.  For example, Soreon Research, a leading independent research firm, projects that the wearable healthcare market will reach $41 billion by 2020—with diabetes, obesity, sleep disorders, and cardiovascular disease as the largest growth segments in the market.  From my perspective, a combination of the ability to collect data along with big data analytics capabilities will drive this market.  And as the market booms and the technology becomes more sophisticated, legal and regulatory issues loom.  Here are a few issues of which to be mindful:

  • Data privacy and security (who has access to the data, who owns the data, how long the data will be used, etc.).
  • Potential changes to malpractice liability (clinicians having access to more information regarding a particular patient, providers ability to review the voluminous data, etc.).
  • Employer issues (wellness programs, ADA concerns, etc.)
  • FDA.

I have only touched on a few issues.  Other issues such as reimbursement (particularly Medicare), use of telehealth in ACOs and similar models, antitrust, use of diagnostics and peripherals, scope of practice, and privacy and security will be some of the frontline telehealth issues in 2016.  We look forward to addressing all of those issues throughout next year.

New AHRQ Research Report Sheds Some Light on Telehealth

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Research_HeroOne of the issues with which we often grapple in the telehealth space is the relative lack of availability of studies and data when compared to other areas of the health care sector.  Telehealth is relatively young and therefore has not had the time to build a voluminous body of data and evidence.  But things are changing.  Many stakeholders are doing exemplary work in telehealth research, and stakeholders like the Department of Veterans Affairs have longstanding evidence regarding the efficacy of telehealth.  However, it’s a more recent document that has caught my attention.

A draft report prepared for the Agency for Healthcare Research and Quality (AHRQ) helps to clarify the existing research regarding telehealth.  The report provides a framework and an evidence map of the available research regarding the impact of telehealth on health outcomes and care utilization.  A detailed description of the methodology used is included in the report as well as an appendix detailing the included and excluded studies the authors considered.

The document is the result of a request from Senators John Thune (R-SD) and Bill Nelson (D-FL) for a literature review examining the value of telehealth and remote patient monitoring with a focus on expanding access to care and reducing costs.  Some of my takeaways from the draft report:

  • Initial searches confirmed that there is a large volume of literature consisting of both primary studies and systematic reviews regarding applications of telehealth.
  • There is broad evidence about the effectiveness of telehealth, including over 200 systematic reviews and hundreds of primary studies published since 2006.
  • A limitation of the authors’ literature review was the use of the term “telehealth” and how stakeholders have varied definitions of the term—making searching literature and identifying relevant studies challenging.
  • Another challenge of the literature review was the uneven quality of studies within the reviews whereby lower-quality studies were less likely to find an effect even where one exists.
  • Although the report found that many previous reviews were not structured in a way that would support current decisions related to telehealth, the report did identify 44 systematic reviews that addressed several important clinical focus areas.
  • The largest volume of research reported that telehealth interventions produce positive results when used in the clinical areas of chronic conditions and behavioral health.
  • Telehealth also yielded positive results when used for providing communication/counseling and monitoring/management.
  • Areas that could be the focus of future systematic reviews include telehealth for consultation, acute care, and maternal/child health.
  • Topics identified as having a limited evidence include telehealth for triage in urgent/primary care, management of serious pediatric conditions and the integration of behavioral and physical health.
  • No studies have yet been able to assess the contribution of telehealth to value-based models given how relatively new these models are.

Report Recommendations

The authors of the draft report also make some interesting recommendations regarding the best ways to advance telehealth. First, they recommend developing additional research in a variety of clinical areas, including triage in urgent care and management of serious pediatric conditions. Second, the authors call for more systematic research reviews in consultation, acute care, and maternal/child health. Finally, the authors encourage research in emerging models of care such as value-based programs where telehealth may improve quality outcomes.

The draft report is very valuable in synthesizing some of the existing literature, and is open for comment until 11:59 p.m. Eastern time on January 5, 2016.  When finalized, this report could have an influential impact on policymakers’ thinking.  I plan on submitting comments regarding the draft (including my view that there are existing studies that should have been considered that were not).  I urge all stakeholders to do the same.

Recent Telehealth Survey: Providers Are Catching On

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EHRA recent survey conducted by the Robert Graham Center, the American Academy of Family Physicians, and Anthem caught my attention. The survey was conducted to gauge the attitudes of primary care physicians regarding telehealth.  And the results make for interesting reading— providing great insight into how certain providers view and use telehealth. What struck me most is that while great progress has been made in the rate of telehealth adoption among providers, we still have a way to go. According to the survey report, state legal and regulatory issues, reimbursement, and provider training and education continue to be serious barriers to wider adoption of telehealth.  And until the landscape evolves to address these barriers, telehealth adoption is likely to stagnate despite the great promise of telehealth holds as a tool to improve quality and access.

By way of quick background, approximately 1,500 family physicians responded to the survey with 15% responding that they use telehealth in their practices (although almost nine out of 10 family physicians indicate that they would use telehealth if they were appropriately reimbursed).  Here are some other interesting takeaways from the survey.

Users of Telehealth

As you might expect, the survey report confirms what most of us in this space suspect.  First, the survey finds that physicians practicing in rural areas are far more likely to use telehealth in their practice than urban physicians (almost 29% to 11%).  Second, physicians who use telehealth are younger and in practice fewer than 10 years. Third, almost all telehealth users reported that they use EHRs in providing care to their patients.

Generally, both telehealth users and non-users agreed that telehealth has the potential to improve health care access, improve continuity of care, and decrease travel time for patients.  And while there was general agreement that patients preferred to see their physicians in-person, there was also an acknowledgment that telehealth “may represent an alternative to seeing a physician at all.”  In other words, even those physicians who did not use telehealth saw the value in its use almost to the same level as telehealth adopters.

Form of Telehealth

Among users of telehealth, approximately half have used telehealth one to five times in the past year and about a quarter report using telehealth more than 20 times in the past year. The form of telehealth used most:

  • 48.7% used real-time video
  • 30.7% used store-and-forward or text
  • 10.8% shared a computer screen using images with audio
  • 9.6% used other forms

Uses of Telehealth

More surprising for me was the variety of ways in which telehealth is being used by primary care physicians.  Survey results show the following uses:Telehealth Licensure

  • 55% for diagnoses or treatment
  • 26% for chronic disease management
  • 20% for second opinion
  • 21% for follow-up
  • 13% for other reasons
  • 16% for emergency care
  • 6% for administrative purposes

So, what does this all mean? For me, it is further confirmation that telehealth is widely accepted by physicians generally but that many barriers will need to be overcome for telehealth to become more routine among physicians and other providers. The survey report notes that “creating guidelines for the use of telehealth services in clinical practice, definitions of quality, and measurable outcomes” are a must for greater adoption. The report also underscores the need to establish “standardized reimbursement procedures” for telehealth including the development of new billing codes and reimbursement mechanisms. I wholeheartedly agree with all of those conclusions. Many stakeholders are working on solutions to one or more of these barriers. Ultimately, however, I think significant change will come from consumers and patients themselves, who will continue to demand better access and more innovative delivery models outside the conventional office visit.

The Boom in Telemental Health

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Telemental health seems to be emerging, even booming.  Also referred to as telebehaviorial health, e-counseling, e-therapy, online therapy, cybercounseling, or online counseling, for purposes of this post, I will define telemental health as the provision of remote mental health care services (usually via an audio/video secure platform) by psychiatrists, psychologists, social workers, counselors, and marriage and family therapists.  Most services involve assessment, therapy, and/or diagnosis.   Over the last few years, I have seen a wider variety of care models—from hospitals establishing telepsychiatric assessment programs in their emergency departments to virtual networks of mental health professionals providing telemental health services to underserved areas to remote substance abuse counseling being provided to inmates in state prisons.VA telehealth

Even the federal government is in on the act.  For example, in 2010, the Veterans Health Administration established a National Telemental Health Center. In 2013, the center provided almost 3,000 video encounters to 1,000 patients at 53 sites in 24 states.  The scope of the services the center provides includes all mental health conditions with a focus on post-traumatic stress disorder, depression, compensation and pension exams, bipolar disorder, behavioral pain and evidence-based psychotherapy.

There are many reasons for the recent boom.  First, telehealth is a good fit for providing mental health services because providers rarely have to lay hands on the patient in conventional face-to-face encounters.  Second, telemental health is accepted by a large number of payers as a legitimate use for telehealth—more so than other telehealth disciplines. As an example, most Medicaid programs and many private insurers cover and reimburse for telemental health services.  Finally, patients surveyed have consistently stated that they believe telemental health to be a credible and effective practice of medicine, and studies have found little or no difference in patient satisfaction as compared with face-to-face mental health consultations.

The Need for Telemental Health

In essence, we are stuck in a vortex of sorts with millions of Americans suffering from mental illness or substance abuse disorders combined with a shortage of qualified mental health providers to address these issues.  The numbers speak for themselves.

In addition to the high numbers described above, there is a critical mental health provider shortage creating significant access to care issues.  Here is a snapshot:

You get the idea.  And even with mental health parity laws, cost of care remains an issue—not to mention the social stigma and mistrust of mental health providers that exists in many communities.Mobile phone

Telemental health is bridging the gap.  Numerous studies have shown the effectiveness of telemental health services.  For example, a recent study showed that providing telemental health services to patients living in rural and underserved areas significantly reduced psychiatric hospitalization rates.  Another study concluded that the effects of telemental health on low-income homebound older adults were sustained significantly longer than those of in-person mental health services. Many other studies arrive at the same conclusion.  Note, however, obstacles remain, including how to properly assess non-verbal cues by video, technical difficulties, and the lack of proper training of many providers regarding telehealth.

Practice Guidance

There is also good news in that, unlike other telehealth subspecialties, there is a well-developed library of practice guidelines available regarding telemental health.  The American Psychiatric Association, American Psychological Association, National Association of Social Workers, Association of Social Work Boards, TeleMental Health Institute, for example, all have guidelines or statements related to telemental health.  The American Telemedicine Association has developed a series of practice guidelines over the years related to telemental health, including its latest regarding using real-time videoconferencing to provide online mental health services. There are also other resources such as the telehealth resource centers that provide guidance on telemental health.

Legal & Regulatory Issues

As with all things telehealth, however, there are a number of significant legal and regulatory issues implicated by the use of telemental health, including privacy and security, follow-up care, emergency care, treatment of minors, and reimbursement. While telemental health touches on some federal laws and regulations (e.g., HIPAA), most of the significant issues involve state law.  And as you might imagine, the result is an inconsistent patchwork of laws and regulations that vary widely by state.

We recently completed a 50-state survey of laws and regulations that may be implicated by the use of telemental health services to assess a variety of issues such as privacy, follow-up care, treatment of minors, and provider scope of practice.  Here are a few nuggets:

  • Psychiatrists, as practicing physicians, must comply with all the obligations that apply to physicians practicing telehealth generally. Very few states exempt mental health from physician requirements despite the fact that many psychiatrists never lay hands on patients. Ironically, Texas is one of the few states that explicitly carves out mental health services from other telehealth requirements.
  • In Delaware, an individual practicing “telepsychology” must conduct a risk benefit analysis and document findings specific to issues such as whether a patient’s presenting problems and Skype 4apparent condition are consistent with the use of telepsychology to the patient’s benefit; and whether the patient has sufficient knowledge and skills in the use of technology involved in rendering the service or can use a personal aid or assistive device to benefit from the service.
  • Kansas requires psychologists and social workers providing telemental health services to obtain the informed consent of the patient before services are provided.
  • In Maryland, physicians (psychiatrists) are required to develop a procedure to prevent access to data by unauthorized persons through password protection, encryption, or other means; and develop a policy on how soon an individual can expect a response from the physician to questions or other requests included in transmission.
  • Montana psychologists can initially establish a “defined professional relationship” electronically so long as the means of communication involves a two-way, real-time, interactive platform providing for both audio and visual interaction.
  • To regulate marriage and family therapy therapist, South Dakota relies on the American Association for Marriage and Family Therapy’s Code of Ethics which provides that therapists evaluate whether electronic therapy is appropriate for individuals and inform them of the potential risks and benefits associated with electronic therapy.

As I look over the telehealth landscape, I predict that telemental health will continue its significant growth.  Demand for mental health services will not recede, and coupled with the mental health provider shortage, telemental health will be viewed as a viable solution by more and more clinicians, payers, and policymakers.  There are, however, significant legal and regulatory considerations—especially at the state level— with which stakeholders must wrestle.

Telehealth: The Medicaid Reimbursement Landscape

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medicare1As many of you know, reimbursement for telehealth services is a mixed bag.  On the one hand, private payers generally seem ahead of the curve.  Many leading private insurers reimburse for telehealth.  Generally these coverage policies provide reimbursement for telehealth services when they involve the use of real-time interactive audio, video, or other electronic media for diagnosis and consultation.  Just as significantly, more than half the states and the District of Columbia have passed telehealth parity statutes which require health insurers to provide coverage for services provided via telehealth if those services would be covered if provided in-person.  The picture for private insurer telehealth coverage is generally good and getting better.

On the other end of the scale is Medicare.  I think it is fair to say that no payer lags further behind in reimbursing for telehealth than Medicare.  The numbers tell the story.  The Center for Telehealth and eHealth Law reports that in calendar year 2014, Medicare reimbursed approximately $14 million under its Part B telehealth benefit—or about .0023 percent of total Medicare spending in 2014—a mere pittance.  The real reason for this is that the Medicare telehealth benefit was primarily intended for rural patients.  In addition:

  • The definition of “telehealth” is limited to real-time audio visual communication between provider and patient (in other words, there is no coverage for so-called asynchronous or “store and forward” technology).
  • Fewer than 100 codes are reimbursable under the telehealth benefit.
  • Other restrictions exist related to type of facility where a patient may present, and what kind of provider may deliver services (e.g., physicians, nurse practitioners).

Medicare Advantage offers more opportunities for telehealth coverage, but overall the current Medicare telehealth reimbursement picture is relatively bleak.

medicaidMedicaid Reimbursement for Telehealth

Medicaid telehealth reimbursement exists somewhere in the space between private payers and Medicare.  As you know, Medicaid provides health coverage to about 70 million low-income adults, children, pregnant women, and others.  The program is administered by states who are required to cover certain mandatory services (such as hospital and physician services, home health), but is funded jointly by the states and the federal government.  States do have flexibility to decide what optional services (such as telehealth) to cover beyond the mandatory services.  This has resulted in a patchwork of different coverage policies that vary by state.

Fortunately, there a number of stakeholders that closely track Medicaid telehealth coverage policies by state.  One of these is the Center for Connected Health Policy, which issues a quarterly report reviewing various telehealth legal and regulatory issues for all states.  In its last report (July 2015), the Center found the following regarding Medicaid telehealth coverage:

  • 47 states and the District of Columbia provide some coverage for telehealth (Iowa, Massachusetts, Rhode Island do not according to the report).
  • In many Medicaid programs, the definition of “telemedicine” or “telehealth’ for purposes of reimbursement is limited to services that take place in real time—thereby excluding asynchronous or remote patient monitoring from coverage.
  • Live video is the most predominantly reimbursed form of telehealth with almost all of the states that cover telehealth offering some type of live video reimbursement in their Medicaid programs.
  • Services provided via telephone, e-mail, or fax are seldom covered unless they are used along with other forms of care delivery.
  • Only 9 states (including Illinois, New Mexico, and Virginia) currently reimburse for store-and-forward services. Even in states that do cover store-and-forward, covered services may be iStock_000043291394_Smalllimited—such as in California, where only store-and-forward services related to teledermatology, teleophthalmology and teledentistry are reimbursable under Medicaid.
  • 16 states (including Colorado, Maine, and South Carolina) provide Medicaid coverage for remote patient monitoring although many restrictions exist. For example, in some states, coverage for remote patient monitoring is limited to home health agencies. There are also restrictions regarding the conditions which may be monitored and the type of monitoring devices that may be used.
  • 29 states reimburse a transmission and/or facility fee.
  • 29 states (including Connecticut, Kansas, and Maryland) require some form of informed consent prior to the use of telehealth.

All in all, the picture for Medicaid reimbursement for telehealth is far better than it has been in the past. Each state Medicaid program is different, so stakeholders need to carefully analyze each state’s telehealth coverage policies. My sense is that given the serious fiscal and clinical (e.g., provider shortages, network inadequacy) issues faced by many Medicaid programs, telehealth will increasingly be viewed as a means to seriously address these challenges. We are starting to see this play out in the Medicaid managed care space.

Medicaid Managed Care Coverage

By way of quick background, a majority of states contract with managed care organizations to provide services to certain Medicaid beneficiaries. Generally, these managed care plans receive a monthly premium from the states for each enrollee, and have greater flexibility to cover more services and allows the states to better target and customize services. As the American Telemedicine Association noted in its report on telehealth and Medicaid managed care published last year, “states have increasingly used [Medicaid managed care] to create payment and delivery models involving capitated payments to provide better access to care and follow-up for patients, and also to control costs.” Because of this flexibility, a number of leading Medicaid managed care plans are either already covering telehealth or are developing telehealth initiatives and pilots—especially related to telemental health and teledermatology. In my view, the future looks bright when it comes to Medicaid managed care and telehealth.

Telehealth / Remote Care 2.0: The Coming Disruption

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As stakeholders, legislators and policymakers wrestle with the myriad of issues related to the provision of remote health care, clinical and technological advancements continue apace. What was once an industry focused primarily on the provision of primary care through existing remote platforms is morphing into a highly sophisticated brew of clinical and technological innovation.  In that regard, several trends have caught my attention. While these trends may not squarely fall within the accepted definitions of “telehealth”, they are worth noting because they raise many of the same legal and clinical issues with which we currently wrestle in the telehealth space.  I am limiting my discussion to three of these trends and will address others in a separate post.

iStock_000062830618_SmallWearable Devices

The wearables industry is projected to significantly increase in the next few years. Generally speaking, wearables are devices (which usually include microchips or sensors) that, among other functions, collect data, and track fitness and wellness.  A leading research firm projects that the global wearable devices market will reach $37 billion in 2020—a significant jump from $1 billion just a year ago. Moreover, wearable device shipments are projected to grow from about 20 million shipments last year to 135 million by 2018.  Wearables are part of a greater trend in which everything is connected to a network—the so-called Internet of Things.  There are about 12 billion Internet-connected devices currently in existence worldwide—the equivalent of 1.7 devices for every person.  That number will increase to a ratio of 4.3 by 2020 when 33 billion devices will be in use.

Many believe wearables are part of a continuum which will lead to wider use of nanotechnology and implantable medicine. As these devices become more sophisticated, they will be better able to integrate collected data into an individual’s EHR and perform more than basic diagnostic testing.

While wearables are essentially in early development, many legal and regulatory issues may be implicated.  Here are a few:

  • Data privacy and security (who has access to the data, who owns the data, how long the data will be used, etc.).
  • Potential changes to malpractice liability (clinicians having access to more information regarding a particular patient, providers ability to review the voluminous data, etc.).
  • Employer issues (wellness programs, ADA concerns, etc.).

These and other legal issues will become more relevant as the wearables sector grows and more sophisticated technological products are developed and deployed.  The real lesson here is that the healthcare ecosystem needs to be prepared to balance clinical and legal concerns with clinical and technological innovation.  That is a tall order especially given how legislators and regulators have approached the regulation of telehealth over the past few years.  Based on that experience, I find it unlikely that policymakers will adjust quickly to the wider use of wearables and the attendant clinical and legal implications that will be brought to bear.

Artificial Intelligence

AI, which uses complex computer algorithms to organize unstructured data, is increasingly being used in the healthcare space. Advocates of AI note that it will enable clinicians and researchers to make full use of the voluminous amounts of data that exists in databases (e.g., cancer registries), EHRs, journal articles, diagnostic images, and wearable devices. Through the use of AI, providers may be able to obtain real-time clinically useful information. For example, included among the more popular uses of AI are:

My sense is that the use of AI in healthcare will increase exponentially in the next few years.   Many of the same legal and regulatory issues implicated by wearables are relevant here. What may be different, however, is that AI presents a myriad of complex and novel issues that are deserving of more discussion and fall outside the scope of this post.

Text Therapy

The Department of Health & Human Services has concluded that only about 40 percent of all adults in need of mental health care actually receive the services. While many are referred for treatment, many barriers exist including costs. It has been estimated, for example, that the median cost of a psychologist’s session is $75.iStock_000019221924Medium

Text therapy is a recent trend that attempts to address the shortfall. Text therapy, through smartphone apps or websites, allows users to connect to a variety of mental health professionals (such as psychologists, social workers, counselors) via text-based or messaging sessions. While models vary, there are some similarities among the offerings:

  • A $25-45 per week subscription fee for unlimited chat.
  • Users must complete and submit a questionnaire.
  • A mental health professional is assigned to the user (some companies use a mental health professional to essentially triage and match the user with a fellow professional).
  • Users can request a different mental health professional than the one who has been assigned.
  • Phone sessions are available for additional fees.

Among the legal and regulatory issues raised by the use of text therapy are licensure, scope of practice (minors, emergencies, follow-up care, etc.), data privacy and security, and reimbursement (many plans do not reimburse for the use of this type of therapy). As these types of services evolve, so too will the laws and regulations, albeit slowly.

Telehealth Crash Course Webinar Series

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headerAs telehealth legal and regulatory issues continue to evolve, stakeholders need to stay current on trending issues. With that in mind, we are offering a complimentary “crash course” webinar series in which we will discuss a number of significant legal and regulatory issues implicated by telehealth including reimbursement, state issues, and employers.

How Do I Get Paid?

During this first installment of EBG’s Telehealth Crash Course series, we will discuss the current reimbursement landscape, including distinctions between various payer models and the growing impact of state parity laws, and some of the current state-specific concerns regarding regulatory issues and risks that may impede development of reimbursement schemes for telehealth services in certain states. (Tuesday, September 8: 2:00 – 2:15 p.m. ET)

Do States Like Telehealth?

In the second installment of EBG’s Telehealth Crash Course series, we will discuss recent legal and regulatory developments in the states related to telehealth and the various initiatives underway to facilitate greater adoption of telehealth. (Tuesday, September 15: 2:00 – 2:15 p.m. ET)

How Do I Implement Telehealth in My Plan?

In the third installment of EBG’s Telehealth Crash Course series, we will examine all of those questions and the potential issues that employers may need to navigate throughout the process of implementing telehealth. (Tuesday, September 22: 2:00 – 2:15 p.m. ET)

How Will My Organization Absorb the Influx of New Patients?

In the final installment of EBG’s Telehealth Crash Course series, we will explore the potential health care immigration issues that employers should be aware of, as well as immigrant options that are available to help health care organizations recruit the foreign talent required to keep pace with a changing landscape. (Tuesday, September 29: 2:00 – 2:15 p.m. ET)

To register for this webinar series, please click here.