Co-Chairs’ Opening Remarks

The Evolving Telehealth Landscape Post-COVID 19: Examining the Opportunities, Challenges and Risks of the Remote Care Revolution

Thomas Ferrante
Partner
Foley & Lardner LLP

Kristi Kung
Partner, Chair, Healthcare Regulatory Practice
DLA Piper LLP, USA

Following the rapid rise of telemedicine spawned by the COVID-19 pandemic, healthcare entities and telemedicine companies are now shifting their focus to the operational, legal, and compliance considerations associated with long term telehealth adoption. In this opening session, our esteemed co-chairs will set the stage for the conference with a high-level exploration of the current and emerging telehealth landscape and the regulatory framework currently governing telehealth practices and services.

Navigating the 50-State Compliance Framework Governing the Licensing and Credentialing of Telehealth Providers

Dan Logsdon
Director
National Center for Interstate Compacts

Kristen McDermott Woodrum
Partner
McGuireWoods LLP

Lisa Robin
Chief Advocacy Officer
Federation of State Medical Boards (FSMB)

Licensure

• Examining the real risks associated with unlicensed practice and the differing standards by role
• Assessing the current status of Multi-State Licensing Compacts for telehealth practices and where they are heading
  • Weighing the limitations and opportunities
  • Understanding the nuances of Psychology Compacts, Nurse Compacts, etc.
• Navigating the requirements and limitations of “special” or “out-of-state” licenses
  • Evaluating when a state consultation exception will work for telehealth and its limitations
• Exploring state flexibilities extended during the COVID-19 public health emergency which waived or suspended certain licensing requirements, extended temporary practice laws, or enacted legislation to make cross-state licensing extended or permanent
  • Where are these state initiatives being rolled back, and which states have enacted them permanently?
• Understanding the need for licensure safeguards around EHR, scheduling and billing and how to implement them

• Navigating the telehealth credentialing process
• Understanding the “credentialing by proxy” process and its benefits, risks and limitations
• Ensuring compliance with the latest requirements of the Federation of State Medical Boards (FSMB), Centers for Medicare and Medicaid Services (CMS), The Joint Commission (TJC), and other relevant agencies

Morning Coffee Break

Maneuvering Through Evolving State Regulations on the Scope of Practice for Telehealth Providers and Establishing a Doctor/Patient Relationship

Tori Lallemont
VP & Assistant General Counsel
OneMedical

Lisa Mazur
Partner
McDermott Will & Emery

Michael Petegorsky
General Counsel & Head of Public Affairs
Mindbloom

Janice Tam
VP of Legal & Corporate Secretary
Rune Labs

• Analyzing state by state telehealth regulations that apply to the physicians and nurses, their scope of practice and how to establish a doctor/patient relationship through telemedicine
• Understanding different state’s definitions of what constitutes “telemedicine” following the pandemic
• Minimizing potential compliance risks by developing a comprehensive telehealth policy with regard to:
• Scope of services
• Clinical guidelines
• Patient eligibility criteria
• Provider qualifications
• Technology requirements
• Informed consent

Networking Luncheon

Understanding the Unique Legal Risks Associated with the Asynchronous DTC Telemedicine Model

Melissa Bianchi
Partner (Digital Health Lead)
Hogan Lovells

Lee Nutini
Associate Director, Senior Counsel
Ro

• Analyzing the specific legal, regulatory and compliance considerations for DTC telemedicine providers that leverage asynchronous technologies
  • E.g. adaptable medical intake forms, symptom survey questionnaires, image sharing, clinical decision trees, etc.
• Understanding the ways that asynchronous DTC telemedicine intensifies legal concerns surrounding HIPAA data disclosure and physician malpractice exposure
• Conquering the risks to patient privacy and security against internet tracking technologies, while still improving a companies’ bottom line
  • Establishing best practices to navigate privacy laws and remain HIPAA compliant
  • Understanding the legal implications of patient data sharing
• State considerations on transaction approval requirements and management service arrangements in DTP telehealth

Ensuring Compliance with Evolving Federal and State Telehealth Billing and Reimbursement Requirements In the Wake of the COVID-19 Public Health

Jody Erdfarb
Partner
Wiggin & Dana LLP

Rebecca Simone
Partner
Nixon Peabody LLP

• An overview of state reimbursement flexibilities for telehealth that were implemented during the pandemic
  • Understanding which flexibilities have ended, which are being temporarily extended and which have been permanently codified into law
• Insight on proposed state legislative changes on telehealth billing and reimbursement that are coming down the pike; and navigating the risks posed by regulatory changes
• Identifying the risks associated by the delivery of telehealth in states that currently cover (and do not cover) Medicaid and CHIP services
• Examining current and future mandates for commercial payors and what they cover
• Evaluating the potential permanency of the Centers for Medicare and Medicaid (CMS) telehealth flexibilities
• Assessing whether Accountable Care Organizations (ACOs) will offer telehealth services in anticipation of the looming December 31, 2024 expiration date

Afternoon Break

Case Study

Ensuring Non-Discrimination in Telemedicine: Facilitating Telehealth Equity and Accessibility in Compliance with Federal Laws

• A comprehensive overview of the legal and regulatory framework governing telehealth accessibility
• Understanding what practices telehealth providers must implement in order to be compliant with protections afforded by:
  • The Americans with Disabilities Act (ADA)
  • Section 504 of the Rehabilitation Act of 1973
  • Title VI of the Civil Rights Act of 1964
  • Section 1557 of the Patient Protection and Affordable Care Act
• Examining recent guidance released by HHS Office for Civil Rights (OCR) regarding telehealth accessibility
• Best practices for telehealth service providers to increase accessibility
• Identifying and addressing implementation factors such as digital literacy, technology, and analytics
• Real-life examples of telehealth companies getting into trouble for lack of accessibility

Spotlight on Cybersecurity: Navigating the Data Privacy and Protection Landmines that Plague Telehealth

Christopher Logan
Senior Vice President & Chief Security Officer
Censinet

Carolyn Metnick
Partner
Sheppard, Mullin, Richter & Hampton LLP

Nicholas Heesters
Senior Advisor for Cybersecurity
U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR)

• Addressing the increased enforcement focus of HHS and OCR on telehealth and protected health information
• Wearables and tracking technologies in telehealth: understanding the inherent data privacy compliance risks
  • Examining FTC’s recent enforcement measures to prevent the collection and monetization of sensitive information through conduct exploiting locations, health data, and other private information
• Understanding the DOJ’s use of the False Claims Act to enforce cybersecurity flaws
• Assessing the cybersecurity risks associated with telehealth provider use of supply chains and third-party vendors
• What policies, practices and protocols should telehealth providers be implementing in order to protect confidential information?
• Navigating compliance with varying state data privacy laws
• Analyzing cross-border challenges to data and privacy

The Role of AI in Remote Care: Exploring the Latest Applications, Opportunities, Ethical Implications and Compliance Challenges

Dan Kagan
Attorney
DLA Piper LLP, USA

Michelle McGovern
General Counsel
Verana Health

• Examining the various ways AI is being utilized in connection with telehealth – chatbots, clinical survey assessments, diagnostics, health record/data analysis and more
  • Best practices to identify and avoid inherent clinical, legal, and ethical risks
• Understanding how telehealth providers can seize the opportunities presented to patient care via AI while avoiding legal and ethical risks
• Examining the effects of AI on the patient-provider relationship

Conference Adjourns

Opening Remarks from the Co-Chairs: Welcome Back & Recap of Day 1

Thomas Ferrante
Partner
Foley & Lardner LLP

Kristi Kung
Partner, Chair, Healthcare Regulatory Practice
DLA Piper LLP, USA

Tele-Prescribing in the Crosshairs: Navigating the Latest Regulatory Activity Coming From the DEA, HHS, and Other Agencies Governing Tele-Prescriptions of Controlled Substances

Libby Baney
Partner
Fargre Drinker Biddle & Reath LLP

Thomas Ferrante
Partner
Foley & Lardner LLP

Hilda Gurley
Principal
Pharmacy Compliance Strategies, LLC

Kaytie M. Ravega
Partner
Quarles & Brady LLP

• Examining the evolution of the Ryan Haight Act since 2008
• Tackling the uncertainty of looming rule changes by the DEA & SAMHSA to the prescription of controlled substances via telemedicine
• Addressing how telehealth providers can operationalize new regulatory changes coming down the pike without sacrificing efficiency, business growth and their bottom line
• Critical takeaways for efficient and compliant Telepharmacy implementation efforts
• Taking a look at concrete real-life scenarios where tele-prescribing practices have come under agency scrutiny
• What telehealth companies need to know about the FDA’s new proposed rule on Nonprescription Drug Products with an Additional Condition for Nonprescription Use

Telehealth Fraud and Abuse: Steering Clear of The Next Frontier in F&A, False Claims Act and Qui Tam Enforcement

Roger Cohen
Partner
Goodwin Procter LLP

Marc Goldsand
Partner
Goldsand Friedberg

Brian McEvoy
Partner
Baker & Hostetler LLP

• Examining the DOJ’s and HHS’ heightened scrutiny of telemedicine fraud and current enforcement trends faced by the industry
• The specific arrangements and activities that the OIG shines a spotlight on in their recent Special Fraud Alert on telehealth
• Takeaways from the recent criminal charges and FCA civil settlements arising from the abuse of special telehealth billing rules
• How telemedicine companies and providers should be evaluating their current compliance programs, billing practices, accuracy of their documentation and third-party relationships to best avoid scrutiny and targeting by federal enforcement agencies
• Stark and Anti-Kickback developments and guidelines impacting telehealth providers: counseling companies on how to stay out of the government crosshairs
• Addressing the specific fraud and abuse implications of the DTC Telehealth model

Morning Coffee Break

Remote Patient Monitoring in Telehealth: Avoiding Key Compliance Pitfalls and Understanding When FDA Regulation and Oversight Comes Into Play

Carrie Nixon
Co-Founder and Managing Partner
Nixon Gwilt Law

Carol Yarbrough
Telehealth Business Operations Manager
UCSF Health
Manager, Government Billing & Reimbursement
UCSF Clinical Practice Group at ZSFG

Benjamin M. Zegarelli
Of Counsel
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

• Overcoming the top billing compliance and reimbursement challenges faced by providers for RPM and remote therapeutic monitoring (RTM)
• Understanding when a telehealth company is utilizing or marketing a “medical device” regulated by the FDA: what does this additional layer of FDA regulation look like?
• Assessing when you can utilize the FDAs definition of “device” to qualify for reimbursement without qualifying for FDA oversight and regulation
• Examining when durable medical equipment (DME) is used in connection with RPM, and the recent governments enforcement priorities with regard to DME
• Key takeaways to ensure a company’s compliance with data privacy issues when using RPMs or DMEs
• Identifying and ensuring patients’ rights when utilizing RPM in telehealth

Networking Luncheon

Best Practices for Contracting Between Telehealth Providers, Technology Vendors, and Life Sciences Companies

Rujul Desai
Partner
Covington & Burling, LLP

Charles C. Dunham, IV
Shareholder
Greenberg Traurig, LLP

• Establishing legal protections to secure the telehealth provider’s best interests and business growth, while maintaining a vendor’s proprietary interests, and advancing patient access
• Balancing the technology, maintenance, and support services offered by a vendor with the needs of the provider and health of the patient: implementing safeguards to protect the interests of all parties
• How to structure service levels offered and the extent of each
• Structuring agreements: contracting dynamics to consider and sample language to illustrate must have provisions and red flags to avoid

Afternoon Break

Special Legal Considerations and Risks for Providers of Behavioral, Reproductive and Gender Affirming Healthcare Via Telemedicine

Lisa Kechijian
Assistant General Counsel
Verana Health

Kristi Kung
Partner, Chair, Healthcare Regulatory Practice
DLA Piper LLP, USA

• Traversing the legal and compliance nuances of delivering behavioral telehealth and avoiding common legal and enforcement pitfalls
• Navigating state abortion laws and those laws that protect abortion providers
• Best practices to combat challenges created by conflicting state laws governing reproductive and gender affirming healthcare via telemedicine

Closing Remarks – Conference Ends