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September 2015 PLUS Journal 1

September 2015 Vol. XXVIII Number 9

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Telemedicine Law and Liability: 2015By Joeseph P. McMeniman & Paul A. Greve, Jr., JD, RPLU

Joeseph P. McMeniman is the AV-rated Principal at McMenamin Law Offices, PLLC, in Rich-mond, VA and serves as Principal Consultant to the Venebio Group. Dr. McMenamin has 30 years of experience in defending health care providers and phar-maceutical, medical device, and biotech companies against a variety of allegations in state and fed-eral court He can be reached at joe.mcme-namin@venebio.com.

Paul A. Greve, Jr., JD, RPLU, is Executive Vice President at Willis Health Care Practices. He can be reached at paul.greve@willis.com.

Telemedicine has been growing exponentially in recent years and will continue to do so over the next decade. Telemedicine has the potential to improve care and reduce cost, goals fully consistent with the aims of health care reform. Indeed it is mentioned in the Affordable Care Act for just that purpose.1

Congressman Mike Thompson, D-California, introduced the Medicare Health Parity Act of 2015 on July 7, a bill that would expand coverage for telemedicine for Medicare beneficiaries. Thompson and his three co-sponsors said the bill would place Medicare “on the path toward parity with in-person healthcare visits.” Thompson also said, “Both patients and providers want telehealth for two simple reasons—it saves money and saves lives.” 2

Telemedicine raises many legal issues, particularly from a regulatory and liability perspective. It is important for underwriters, agents, brokers, health care lawyers and risk managers to understand the legal implications of telemedicine. This article is a brief overview of some of those issues.

Telemedicine DefinedThere has never been consensus on the definition of the term “telemedicine.” The term “telehealth” is sometimes used as well and may comprise non-clinical services. The terms may or may not be interchangeable depending on the context, but the American Telemedicine Association does consider

them to be synonyms and as “encompassing a wide definition of remote health care.” 3

In 2014, the AMA issued a report on Coverage and Payment for Telemedicine. In it they described three different, broad types of telemedicine technologies: remote monitoring technology, store-and-forward technology, and (real-time) interactive services. The last category is the one most often considered as best fitting the definition of telemedicine.4

Store-and-forward technology allows for “asynchronous” communication in which images or data are stored and sent as files to providers who then respond with an assessment.5

Types of Telemedicine ServicesPrimary care/specialist consultation

These consultations serve diagnostic purposes. They often involve live interactive video. They can also entail transmission of patient vital signs, old records, video clips, and especially diagnostic images.6 Teleradiology has burgeoned over the last decade.

Especially for interactive video, the challenge is for providers to judge when the patient needs to be seen in person rather than over a screen.7

Remote patient monitoring

This category of telemedicine uses technologies to gather data for interpretation and transmit them to a remote diagnostic testing facility (“RDTF”) or to another entity such as a

clinic, hospital, physician’s office, or home health agency. Examples may include such information as vital signs, electrocardiograms, blood tests, and others. Although generally healthcare professionals interpret this information, patients can themselves use sensors to measure their own personal indicators of disease at home as well. 8

Telemedicine LiabilityTo date there has been an almost infinitesimally small number of reported malpractice claims involving telemedicine. Even in those cases filed, telemedicine may not be the primary focus of the plaintiff ’s lawyer. Often, it is merely part of a fact pattern.

The defense of telemedicine malpractice claims can be complex for many reasons. One is simply that the dearth of case law frustrates the student of the subject. Jurisdiction is problematic across state lines. Though most commentators take the position that the care is provided at the patient’s location, and that the courts of his state therefore have jurisdiction, this theory has not been much tested either. With respect to venue, one locale may have plaintiff-oriented judges and juries; another may not. Although most states have adopted a national standard of care, some retain state standards, and a few define the standard as the custom within the defendant’s locality or like localities. If a doctor from a state with a national standard provides distance care to a patient in a state embracing the locality

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standard, which standard applies—and from what pool can experts be selected? Then too, even where the standard’s definition is clear, technological evolution will mean that its practical application will change over time. State statutes, rules and regulations governing telemedicine also vary by jurisdiction. Plaintiffs will argue, of course, that the standard of care using telemedicine technology is the same as it is when a physical exam is conducted in person. Some states have, in fact, codified the standard of care accordingly.9 As of this writing, however, in no state has the court of last resort tested this notion under common law.

Many specialty societies have promulgated guidelines or other documents on the use of telemedicine. The American Telemedicine Association has done so as well. More are under development. While in theory these statements can help minimize risk if used appropriately, plaintiffs can argue that they establish the standard of care. There is evidence, in fact, that such guidelines are used more often as a sword than as a shield.10 The problem is aggravated by the fact that as of four years ago there were already more than 2700 clinical practice guidelines promulgated by more than 350 groups, and among them there were many inconsistencies.11 No doubt there are many more now. The problems with guidelines do not end there: they tend to be inflexible, they are vulnerable to rapid obsolescence, they are often vague, they frequently fail to specify the basis for any given recommendation, and they are often written by authors with conflicts of interest, such as ties to industry. There is not even a consensus on the meaning of “evidence-based.”12

Claims ScenariosAs noted, telemedicine-related claims have been very few in number. One must resort to polling carriers and defense counsel to find the few that have been filed.

Because teleradiology has been one of the most prevalent modes, claims to date can often fall under that category. Allegations include:

•Incorrect interpretations of diagnostic images of various types by a radiologist, from home or some other remote location;

•Miscommunication over the timeliness of the required reading: e.g. a “stat’ reading was requested but not provided;

•Failure to communicate presenting symptoms to a remote, examining neuro-radiologist; failure to timely diagnose a spinal abscess resulting in permanent impairment;

•Incorrect remote reading of fetal monitoring strips by an obstetrician;

•Suspected stroke incorrectly diagnosed by a tele-stroke consult;

•Failure to adequately remotely monitor and assess an ICU patient for blood loss and hypotension resulting in severe brain damage; failure to summon an intensivist for a more thorough bedside evaluation.

Other Potential Telemedicine Allegations:

•Exam should have been performed in-person rather than by videoconference.

•Image distortion causing misdiagnosis

•Incomplete telemedicine examination

•Power failure during a consult causing delay/error

•Negligent prescribing based on a video examination

•Negligent failure to provide telemedical support

Licensure and Scope of PracticeHistorically, states regulate health care professionals through licensure. The professional’s license is an indication of some basic level of qualification, and the main tool states use to promote satisfactory physician performance. Without a valid license, a health care professional may not lawfully serve patients except in emergencies and other special circumstances. Even in emergencies, some states permit practice without a license only if services are provided pro bono.13 Generally, licenses are valid only within the state of issuance.

A telephysician must be mindful of this restriction. If he serves a patient in a state where he holds no license, he may be accused of unauthorized practice. As the law stands now, doctors wishing to see patients in a variety of states should be licensed in all of them. A number of legislative proposals have been crafted to obviate the need for multiple licenses, but none has been enacted as yet. The Federation of State Medical Boards (“FSMB”) has created an Interstate Medical Licensure Compact that still contemplates licensure in each state where a physician practices, but that makes the associated administrative burden somewhat easier.14 As of this writing, some eleven states have enacted the Compact into law.15 The expense and inconvenience of maintaining a series of licenses, each subject to different rules, are burdens outweighed by the

risk of practicing without a license.

Health care providers (“HCPs”) must also conform to scope of practice requirements, which may also vary state-to-state. For example, in Virginia, a nurse practitioner may interact with her collaborating physician by electronic communications, but that may not be true in other states;16 Virginia physicians’ assistants enjoy no such freedom. The professional needs to become acquainted with the varying requirements in each state where she practices.

Credentialing and PrivilegingA hospital’s Board of Directors is ultimately responsible for its credentialing and privileging decisions. Credentialing refers to obtaining, reviewing, and confirming a HCP’s credentials and professional documentation; privileging refers to an organization’s judgment, based on peers’ evaluations of a HCP’s credentials and performance, on the scope and content of patient care services that the HCP may provide within its walls. In conventional care, a physician submits his credentials and the Board’s delegee, usually a committee of the medical staff, decides whether to grant privileges or not and, if granted, their extent. If the credentialed physician wishes to serve patients at another hospital, however, his existing privileges generally are insufficient to permit that, and he has to go through the same process again.

Much of telemedicine’s value lies in bringing expertise from large centers to smaller ones. Until fairly recently, however, even a highly qualified doctor at a major medical center willing to assist inpatients elsewhere would be obliged to go through the credentialing process at the smaller hospital. Under Federal “Conditions of Participation” regulations promulgated in 2011, however, so long as specified requirements are met, the smaller hospital may, in large part, rely upon the credentialing decisions made at the larger.17

Privacy and ConfidentialityFew data are more sensitive and private than medical records, especially those that document psychiatric care, sexually transmitted diseases, and other delicate topics. Hackers can and do invade data at the Pentagon; recent headlines have repeatedly reported data breaches, sometimes massive, at health care institutions and insurers. Both federal (HIPAA18, HITECH19, COPPA20) and state law prohibit such conduct; moreover, ethical principles condemn them as well. Intentional misconduct aside, simple human error, the

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commonest mechanism of privacy breaches, is both unlawful under state and federal statutes and actionable at common law. No exception exists for distance care. Of course, traditional paper records are far from risk-free as well, but those wishing to serve patients at a distance should be at pains to identify and ameliorate risk. The consequences for failing to do so may be severe.

Fraud and AbuseThe Stark law21 and the anti-kickback statute22 apply to telemedicine just as they do to in-person care. Several OIG opinions deal explicitly with telemedical arrangements,23 and those should be consulted if, for example, a hospital wishes to provide a physician with

some of the equipment needed to perform distance care services.

FDATo some extent, telemedicine relies upon devices used for diagnosis and sometimes treatment. A large and ever-growing number of mobile apps is on the market, most of which have not been validated in clinical trials nor approved by FDA. So far, FDA has taken a fairly restrained approach, and stayed its regulatory hand to, it seems, encourage the growth of the technology. Apps that are not devices at all, such as a medical textbook made available electronically, are not regulated. Others that could be are not, at least at present; FDA seems to be focused only on

apps that could influence diagnostic or management decisions as opposed to, for example, apps intended to prevent disorders from arising or to encourage fitness.24

ConclusionTelemedicine has a bright future, and will facilitate access to care as few other technologies can. It is increasingly popular for its convenience and low cost. Its growing popularity, however, will undoubtedly give rise to tort claims. Moreover, it is subject to extensive regulation. For risk management and claims defense purposes, insurers willing to underwrite these risks and providers seeking to offer distance care should acquaint themselves with relevant law.

Endnotes1 American Telemedicine Association. ”Telemedicine and the Affordable Care Act”. http://

www.americantelemed.org/docs/default-source/policy/telehealth-provisions-within-the-patient-protection-and-affordable-care-act.pdf. 2010. Accessed July 30, 2015.

2 Wicklund, Eric. ”Congress gets another chance to advance telemedicine”. http://mhealthnews.com/print31881, accessed July 29, 2015.

3 http://www.americantelemed.org/about-telemedicine/what-is-telemedicine#.VbFGG-PlViko, accessed July 22, 2015.

4 http://www.jonesday.com/files/upload/AMA%20Policy%20on%20Telehealth%20(June%202014). Page 1 of 5.PDF, Jones Day, May 2014, accessed July 22, 2015.

5 Sikka, Neal M.D. et al. ”Telehealth in Emergency Medicine: A Primer”. American College of Emergency Physicians, Telemedicine Primer, June 2014, 1. Except in certain demon-stration projects in Alaska and Hawaii, Medicare will not cover asynchronous services. CMS Medicare Learning Network, “Telehealth Services,” (2013), available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProd-ucts/downloads/TelehealthSrvcsfctsht.pdf (accessed July 30, 2015)(hereinafter “Tele-health Services”).

6 American Telemedicine Association, “What is Telemedicine?” (2012), available at http://www.americantelemed.org/about-telemedicine/what-is-telemedicine#.VbFGGPlViko (accessed July 30, 2015).

7 Thadani, Trisha. “Digital Doctor Is Next Wave In Health Care”. USA Today, Money 5B, July 9, 2015.

8 McArthur, Kate. “Teaching medicine, innovation”. Chicago Tribune, Business Section, 2. Monday, July 13, 2015.

9 See for example: Haw. Rev. Stat. § 453-1.3(d) (Supp. 2012); Colo. Rev. Stat. § 10-16-123(2) (2012); 22 Tex. Admin. Code § 174.8(b) (2013).

10 See, e.g., Hyams et al., 122 Ann. Int. Med. 450, 451-52 (1995)(Only 17 of 259 claims reviewed (6.6%) involved clinical practice guidelines; of these, in 12 the guidelines were inculpatory and in 4, exculpatory ); Mehlman, 40 J.L. Med. & Ethics 286 (2012)(In 24 additional reported cases, the defense used guidelines successfully in 9 and the plaintiffs in 11).

11 Institute of Medicine, Clinical Practice Guidelines We Can Trust 146 (2011).

12 McAlister, et al., 4(8) PLoS Medicine e250 at e250 (2007).

13 See, e.g., Okla. Stat. Ann. tit. 59 § 492(D)(2).

14 See, FSMB Interstate Medical Licensure Compact, available at http://www.licenseport-ability.org (accessed July 30, 2015). 15 Id.

16 “Collaboration and consultation among nurse practitioners and patient care team physi-cians may be provided through telemedicine as described in § 38.2-3418.16.” Va. Code Ann. § 54.1-2957.

17 CMS, Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging, 76 (87) Fed. Reg. 25550 (May 5, 2011), available at http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10875.pdf (accessed July 30, 2015).

18 45 CFR Part 160 and Subparts A and E of Part 164, accessible from http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/ (accessed July 30, 2015).

19 Health Information Technology for Economic and Clinical Health Act, 111 P.L 5 (2009) available at http://healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf (accessed July 30, 2015)

20 The Children's Online Privacy Protection Act of 1998 (COPPA), 15 U.S.C. §§ 6501–6506 (Pub.L. 105–277, 112 Stat. 2681-728), available at https://www.law.cornell.edu/uscode/text/15/6501 et seq. (accessed July 30, 2015).

21 Limitation on certain physician referrals , 42 USC § 1395nn, available at https://www.law.cornell.edu/uscode/text/42/1395nn (accessed July 30, 2015).

22 Criminal penalties for acts involving Federal health care programs, 42 USC § 1320a-7b(b), available at https://www.law.cornell.edu/uscode/text/42/1320a-7b (accessed July 30, 2015).

23 See, e.g, OIG Advisory Opinions Nos. 11-12, 99-14, and Op. 02-12.

24 See, FDA, Medical Devices; Medical Device Data Systems Final Rule (76 FR 8637) (Feb. 15, 2011) (to be codified at 21 C.F.R. § 880.6310); and FDA, Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (2013), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu-ments/UCM263366.pdf (accessed July 30, 2015).