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Telemedicine and Mobile Health Innovations Amid Increasing Regulatory Oversight

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Telemedicine and Mobile Health Innovations Amid Increasing Regulatory Oversight COMMENTARY Telemedicine and mobile health innovations amid increasing regulatory oversight By Sharon Klein, Esq., and Jee-Young Kim, Esq. Pepper Hamilton LLP The growing mobile health market is rapidly UNDERSTANDING TELEMEDICINE transforming health care delivery. More than AND MOBILE HEALTH 80 percent of physicians use mobile technology Telemedicine involves direct patient care to provide patient care, and more than and is a subcategory of telehealth, a broader 25 percent of commercially insured patients use concept that includes telecommunications mobile applications to manage their health.1 technologies, or mobile medical applications, Technological advancements, the expansion to remotely support health care, health- of access to health care under the Patient related education, public health and health Protection and Affordable Care Act, Pub. administration.3 Generally, telemedicine L. No. 111-148, the emphasis on cost- involves: effective quality care and the proliferation • Geographic separation between two or of mobile medical applications have pushed more participants or entities engaged in telemedicine to the new frontier of health care delivery. health care. Over the past 50 years, the scope of • The use of telecommunications tech- telemedicine practices has expanded to nology to gather, store and disseminate meet demands for immediate care in both health-related information. remote and metropolitan regions. Mobile • The use of interactive technologies to health, a form of telemedicine using wireless assess, diagnose and treat medical devices and cell phone technologies, conditions. has also evolved. By the end of this year, Mobile health is a medium through which experts expect 2 billion smartphones, telemedicine is practiced. It allows for tablets and other portable devices globally, increased provider and patient mobility, each of which can potentially provide as well as greater delivery of clinical care individuals access to health care information via consumer-grade hardware, such as The WebMD app is shown here. WESTLAW JOURNAL/Kim Sachs from anywhere at any time.2 smartphones and tablets.4 In light of the seemingly limitless opportunities in telemedicine, health care providers, consumers and entrepreneurs must navigate Mobile health allows for greater provider and patient mobility the many risks that come with reliance on and the delivery of clinical care via consumer-grade hardware, these new technologies and comply with an such as smartphones and tablets. increasing number of regulations. RECENT TELEMEDICINE AND MOBILE HEALTH TRENDS The resurgence of telemedicine began in 2011, when the U.S. Centers for Medicare & Medicaid Services issued a much-awaited final rule permitting a more flexible process for credentialing and privileging practitioners who provide these services. The trend escalated in 2013, when federal and state legislation and major insurers expanded Sharon R. Klein (L) is the partner-in-charge of Pepper Hamilton LLP’s office in Orange County, the types of reimbursable telemedicine Calif., where she serves as the national chair of the privacy, security and data protection practice. She can be reached at [email protected]. Jee-Young Kim (R) is an associate in the firm’s health care services. In 2014, the trend continues with services practice in the Los Angeles office. She can be reached at [email protected]. the Federation of State Medical Boards’ adoption of a model policy intended to provide guidance to state medical boards 10 | WESTLAW JOURNAL • HEALTH LAW © 2014 Thomson Reuters for regulating the use of telemedicine Providers should be aware of the staff distant-site telemedicine practitioners technologies.5 reimbursement requirements and restric- will join, the level of involvement they may Increasingly, there are more arrangements tions that may affect their billing practices, have in medical staff committees and the for distant-site specialists to provide tele- know which telemedicine services will be procedural rights they will enjoy. ICU (intensive care unit), tele-stroke and reimbursed and only submit compliant Credentialing and privileging other telemedicine services; partnerships claims to avoid liability for fraud and abuse or false claims. Regardless of telemedicine advancements, between insurers and integrated health care health care organizations remain liable delivery systems to provide patients in rural Fraud and abuse for the care provided to their patients. communities access to specialists through Telemedicine services often involve business Under CMS’ final rule, effective July 5, 2011, telemedicine programs; and development arrangements between unrelated health health care organizations may rely on the of mobile technology for patient monitoring, care entities and may include the lease of credentialing and privileging decisions patient engagement and virtual clinical equipment or the use of a product owned of distant-site hospitals or information encounters. in part by physicians. Such business provided by other telemedicine entities Within the mobile health industry, pharmacy arrangements must be structured in a when determining privileges for practitioners management continues to be the most manner that does not implicate federal who provide telemedicine services as long common use of mobile technologies. Growth fraud and abuse laws, including the Anti- as certain conditions are met, including a will most likely continue as data analytics Kickback Statute and the Stark Law. compliant written agreement.10 vendors launch hosting platforms that make it easier for mobile application developers to comply with federal privacy and security Increasingly, there are more arrangements requirements in the health care arena. for distant-site specialists to provide emergency, stroke and other telemedicine services. NAVIGATING LEGAL ISSUES IN TELEMEDICINE AND MOBILE HEALTH As more health care entities use telemedicine, Under the Anti-Kickback Statute, it is a crime To mitigate possible negligent credentialing more consumers rely on these and mobile to knowingly offer, pay, solicit or receive any claims and associated risks, when entering health services, and more entrepreneurs remuneration to induce referrals of items or into written agreements with distant sites, develop telemedicine technologies, oversight services reimbursable by a federal health care health care organizations must know who 6 and scrutiny by state medical boards and program. Arrangements meeting certain will be providing care to patients, confirm federal and state regulatory agencies also requirements that are set forth in regulatory that any written agreement they sign reflects continue to increase. safe harbors do not implicate the statute. current legal requirements and establish specific responsibilities of distant-site Providers, consumers and entrepreneurs The Stark Law prohibits physicians from hospitals and telemedicine entities. They must be mindful of the following legal issues referring Medicare patients for designated must also ensure that written agreements to ensure their telemedicine and mobile health services to an entity with which the 7 include adequate representations, warranties health services are compliant with federal physician has a financial relationship. It and indemnifications regarding the quality of and state requirements, and appropriately includes exceptions that apply to ownership services provided by the distant site and any protect patient safety and privacy. interests and compensation arrangements involving physicians. entity with which it subcontracts. PROVIDER CONSIDERATIONS Advisory opinions issued by the U.S. Distant sites, in turn, must have processes to assess the quality of their practitioners. Reimbursement Department of Health and Human Services’ Office of Inspector General addressing While distant-site, Medicare-participating Reimbursement continues to be a telemedicine-related fraud issues provide hospitals are highly regulated, distant-site significant barrier to telemedicine. Medicare additional guidance for providers and telemedicine entities are not. Therefore, reimbursement for telemedicine services is entrepreneurs when structuring telemedicine relationships with such entities require limited. Generally, it requires face-to-face arrangements.8 greater scrutiny to assure the quality of the contact between a patient and provider, with telemedicine services being provided and the exceptions for certain telemedicine services Medical staff bylaws qualifications of the practitioners providing provided at eligible facilities located in rural, Health care organizations that provide them. non-metropolitan areas with health care telemedicine services must review and revise Peer review professional shortages. their medical staff bylaws and credentialing The expansion and increased reliance Medicaid reimbursement varies from state and privileging policies to make sure on telemedicine means that health care to state, and only about 20 states have they cover telemedicine practitioners and organizations and telemedicine entities enacted statutes that recognize or require practices. These documents must include must develop policies and procedures for commercial insurers to reimburse for certain criteria for granting privileges to distant-site monitoring telemedicine practitioners and telemedicine services. practitioners and a procedure for applying the criteria to those practitioners.9 They should sharing internal review information. While also address what category of
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