Legal Issues You Should Know April 25, 2018 In-House Counsel Conference

Transcription

1 1 TELEMEDICINE Legal Issues You Should Know April 25, 2018 In-House Counsel Conference

2 Disclaimer: These materials and presentation are intended to be a general and brief summary of the law. This is not intended to be legal advice. 2

3 3 Presenters: Arielle R. Lusardi, Esq., MPH Associate, Health Law Department, Obermayer Rebmann Maxwell & Hippel LLP Robert Plotkin CEO, Arcadian Telepsychiatry Services Kaitlin Rosenthal, Esq. Associate General Counsel, Office of Legal Affairs, Thomas Jefferson University and Jefferson Health Benjamin A. Waters, Esq. Associate, Health Law Department, Obermayer Rebmann Maxwell & Hippel LLP

4 4 Presentation Overview General Overview of Telemedicine The Legal and Regulatory Challenges of Implementing a Successful Telemedicine Program Telepsychiatry and Telemedicine Platforms in Practice

5 5 GENERAL OVERVIEW OF TELEMEDICINE

6 6 What is Telemedicine? Characterized by: Geographic separation Use of telecommunications to gather, store, and disseminate clinical information Types of Telemedicine: Provider-to-Provider Model Provider-to-Patient Model mhealth Model Telemedicine v. Telehealth

7 7 Benefits of Telemedicine Reduces Barriers to Care Creates Greater Efficiency Improves Management of Chronic Conditions Improves Patient Engagement and Satisfaction Promotes Care Coordination

8 8 A Growing Industry Hugely expanding market Estimated to reach over $35 billion in 2018 Drivers of Growth Expanded use of mobile devices Shortage of healthcare professionals Relaxation of laws and regulations governing telemedicine

9 9 THE LEGAL AND REGULATORY CHALLENGES OF IMPLEMENTING A SUCCESSFUL TELEMEDICINE PROGRAM

10 10 Getting Started: What Type of Telehealth Program Are You Implementing? On-demand and scheduled physician appointments Provider-to-Provider Programs Types of Telemedicine Programs Remote Second Opinion Programs Hospital ED and Pre- Admission Testing Programs

11 Getting Started: What Type of Telehealth Program Are You Implementing? 11 Are institutional providers involved? What state laws may be implicated? Questions to Consider Where is the Patient located? Who will be providing the telehealth service?

12 12 Putting It All Together: Getting a Telehealth Program Off the Ground Step 1: Implement a Targeted and Strategic Approach Assess whether the program creates opportunities to generate revenue and reduce costs Conduct a financial analysis to determine whether it makes business sense to expand to other states Consider working with contracted networks of providers already operating in other states

13 13 Putting It All Together: Getting a Telehealth Program Off the Ground Step 2: Understand the Program s Operational Requirements Where additional licensure is required, are there systems in place to track licensure and licensure maintenance? Does the telehealth technology match patient location to provider licensure? Will your providers require credentialing at other facilities?

14 14 Putting It All Together: Getting a Telehealth Program Off the Ground Step 3: State Specific Considerations Do you have malpractice coverage in the target state? Do you understand state-specific requirements related to informed consent, the standard of care, and prescribing? Have you trained your providers on any new state-specific requirements? Are you equipped to handle patient medical records in accordance with state-specific requirements? Do you understand any applicable state-specific reporting requirements?

15 Legal and Regulatory Concerns: Physician Licensure Telemedicine has enabled providers to collaborate and serve patients across jurisdictional boundaries 15 Are all telemedicine activities the Practice of Medicine? Diagnosis, treatment, prescribing Education Where is the physician practicing when engaging in telemedicine? Location of patient Specific state law requirements to consider

16 16 Legal and Regulatory Concerns: Medical Malpractice Standard of Care Issues Medical malpractice liability is determined based on whether the provider performed to the standard of care under the circumstances Important Considerations: Differing standards of care for in-person v. virtual patient services i.e. restricting the ability to prescribe certain medications Differing standards of care across jurisdictions Certain technologies may not meet the standard of care E.g. audio-only v. audio-video telemedicine Malpractice Insurance Coverage Does the insurance provider cover telemedicine services? Does the insurance provider cover the provision of services across state lines?

17 17 Legal and Regulatory Concerns: Physician/Patient Relationship Establishing the Relationship Some states require an in-person consultation prior to engaging in telemedicine States have different criteria for such consultations Continuity of Care considerations Informed Consent Is telemedicine considered novel treatment? If so, may require a specific type of written informed consent by the patient prior to engaging in services

18 18 Legal and Regulatory Concerns: Tele-Prescribing Ryan Haight Online Pharmacy Consumer Protection Act (2008) Provides restrictions on the prescribing of controlled substances over the internet Exceptions for the practice of telemedicine at 21 USC 802(54): Treatment in a hospital or clinic In the physical presence of a provider Government provider setting (VA, HIS, etc.) Emergencies State Laws State laws differ on: When providers can prescribe medications remotely What types of substances may be prescribed via telemedicine

19 19 Telepsychiatry and the Opioid Crisis Opioid Response Act of 2018 Senate HELP (Health, Education, Labor and Pensions) committee making telemedicine prominent strategy in battle against opioid addiction Provisions enable DEA to create a rule allowing qualified healthcare professionals to administer controlled medications via telemedicine Expands providers to include community mental health and addiction treatment centers More leeway to prescribe Medication Assisted Treatment Would enable a special registration, enabling providers to use telemedicine without need for in person exam

20 20 Putting It All Together: Getting a Telehealth Program Off the Ground Step 4: Can you operationalize any state-specific business entity requirements? For example, in a state where a captive PC is required, how will your systems make sure you bill and collect money in the name of the captive? How will you track revenue derived from out-of-state for tax purposes?

21 Reimbursement: Monetizing Your Telemedicine Program Medicare & Medicaid 21 Reimbursement Considerations Private Payors Self- Payors

22 22 Legal and Regulatory Concerns: Reimbursement Issues CMS and Medicare Must have real time, two-way, audio-visual telecommunications system Patient must be in a qualifying originating site (outside of MSA or in a rural Health Professional Shortage Area) Patient must be in a qualified facility such as a hospital or doctor s office Medicaid States exercise discretion over coverage requirements within the general federal Medicaid requirements Private Payors Carefully review contracts for telemedicine coverage requirements

23 23 Legal and Regulatory Concerns: Fraud and Abuse The Anti-Kickback Statute Prohibits the knowing or willful offer or acceptance of any remuneration in an effort to induce referrals The Stark Law Prohibits a physician (or physician s immediate family member) who has a financial relationship with an entity from making referrals to the entity for designated health services ( DHS )

24 24 Reimbursement: Monetizing Your Telemedicine Program Consider other reimbursement arrangements (such as selling your service to large employers who will include it as an employee benefit). Program your systems to appropriately bill for telemedicine services How will you make sure telemedicine services are billed using the codes the payers want? How will you provide self-pay patients with any required notifications?

25 25 Selecting a Telemedicine Platform Vendor Understand your program s technology needs Understand how different platforms will integrate with other systems Conduct an assessment of security components to ensure they meet your institution s security needs Sign a services contract and a business associate agreement

26 26 Legal and Regulatory Concerns: Confidentiality under HIPAA and State Laws Conduct thorough evaluation of telemedicine platform vendors to ensure the security of all communications and records transfer Closely review state confidentiality laws that may be more stringent and restrictive than HIPAA The more restrictive controls E.g. Pennsylvania Drug and Alcohol Abuse Control Act

27 27 TELEPSYCHIATRY AND A PLATFORM IN PRACTICE

28 28 What is Telepsychiatry? The use of technology to facilitate psychiatric care at a distance Emerging trends show growth in direct-toconsumer telepsychiatry: Shortage of psychiatrists Improved reimbursement Removal of licensing barriers Increased acceptance

29 Increased Adoption of Telepsychiatry in Diverse Contexts 29 Emergency Departments Primary Care Community Based Settings Inpatient Units and Residential Programs Medical/Surgical Floors Discharge Planning and Care Management Universities and other School-Based Services Employee Wellness Programs

30 30 Benefits of Telepsychiatry Cost effective. Improved Treatment Adherence & Patient Engagement. Increased Access. Convenient.

31 31 Telepsychiatry v. Traditional Psychiatry No significant differences reported by clients No significant differences noted by behavioral health clinicians

32 32 About Arcadian Founded in 2013, Arcadian Telepsychiatry is a technology enabled behavioral health company. Our leadership team has decades of behavioral health experience, delivering best in class telepsychiatry, tele-eap, and teletherapy services. Acquired by Mynd Analytics (NASDAQ:MYND) in Nov

33 33 The Arcadian Video Platform HIPAA Secure Zoom Video Open API architecture EHR Online Scheduling Capability Compatibility with various scheduling solutions (Google, ical, Outlook, etc.) 24/7 chat Digital BH assessment tools Configurable White Label Solution Does not require download

34 34 The Arcadian Engagement Platform Our online engagement platform combines on-demand telebehavioral services with clinically proven mental wellness programs for a seamless user experience

35 The Arcadian 24/7 Chat Function 35

36 Arcadian s Flexible Pathways 36 Connect with a Counselor Schedule a convenient appointment here LAUNCH >

37 Arcadian s Assessment Capabilities 37

38 Our patient selection and treatment process works to ensure that the best and most effective type of care is provided and that patient safety and confidentiality is maintained 38 SCHEDULING Client evaluated by master level clinician for TMH services by Arcadian clinician or can self schedule Evaluating clinician contacts provider who has specialty in that specific area and is in the state the client resides Client is contacted by provider to schedule appointment CONFIDENTIALITY System compatible with HIPAA Session not recorded Client asked to be in private area during the session No records released unless requested by client and appropriate signatures garnered Session notes saved in secure cloud that is HIPAA compatible RISK MANAGEMENT & SAFETY Client is evaluated for suicidality and/or imminent danger Client is informed of their rights Client and provider review consent forms Consent form signed; sent to provider and saved on HIPAA compliant cloud RISK MANAGEMENT & SAFETY Client informed of confidentiality limitations Client must agree to provide physical address each time he/she meets with provider Client must provide emergency contact within 25 mile radius of where he/she is physically during session

39 Clients Not Appropriate for Video-Based Counseling Actively suicidal or homicidal patients with ideation, plan, and intent Couples experiencing domestic violence in their relationship Alzheimer patients Patients with Active Addiction (Moderate-High Quantity Use) 39

40 40 Special Considerations for Telepsychiatry Many states have more stringent privacy and confidentiality laws for behavioral health and substance abuse Telepsychiatry also raises unique concerns related to emergency situations and the standard of care Involuntary commitment standards and reporting requirements

41 Questions? 41

42 42 Contact Information Arielle R. Lusardi, Esq., MPH: Phone: (215) Robert Plotkin Phone: (215) Kaitlin Rosenthal, Esq. Phone: (215) Benjamin A. Waters, Esq. Phone: (215)