Advanced Forum on Telehealth - WEB

November 15–16, 2023

SpringHill Suites NY Manhattan Times Square South | New York City, NY

Advanced Forum on

Telehealth Legal •

Regulatory • Compliance

A Must-Attend Event for Legal, Regulatory, and Compliance Professionals in the Telehealth, Telemedicine, and Digital Health Industries

Conference Co-Chairs:

Benefit From In Depth Discussions On:

ç Assessing Licensure, Credentialing, and Scope of Practice Compliance Requirements across 50 States

ç The Latest Regulatory Activity Impacting Tele-Prescriptions

ç Steering Clear of Telehealth Fraud and Abuse Violations

ç Navigating the Legal Risks of Direct-To-Consumer (DTC) Telemedicine

ç Evolving Federal and State Telehealth Billing and Reimbursement Requirements

ç Best Practices for Contracting Between Telehealth Providers and Technology Vendors

ç Avoiding Compliance Pitfalls of AI and Remote Patient Monitoring in Telehealth

Benchmark with Industry Leaders from:

ă Censinet

ă Charlie Health

ă Federation of State Medical Boards (FSMB)

ă GoodRX

ă Mindbloom

ă National Center for Interstate Compacts

ă One Medical

ă Ro

ă UCSF Health

ă UPMC

ă Verana Health

ç Special Legal Considerations for Behavioral and Reproductive Telehealth

POST-CONFERENCE WORKSHOP

November 16, 2023

Clock 3:15 pm–6:00 pm

The Nuts and Bolts of Launching and Scaling a Telehealth Business: A Master Class on Building a Telemedicine Business While Managing Compliance Pain Points

Associate Sponsors

Thomas Ferrante Partner Foley & Lardner LLP

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

The Time to Prepare is Now.

As we enter this post-pandemic era, there is every indication that telehealth and telemedicine will continue to grow. As a result, key stakeholders, including health care providers, telehealth companies, digital health platform provider's and practitioners are shifting their focus to the operational, legal, and compliance considerations associated with long term telehealth adoption.

Moreover, as agencies such as the DEA, FDA, HHS, CMS, Office of Civil Rights, and others are continuing to redefine what telehealth looks like in the post pandemic era, companies and their counsel are in need of an in-depth understanding of the full regulatory framework governing telehealth services, agreements and operations.

ACI is pleased to invite you to NYC, this November, to attend to attend our Advanced Legal, Regulatory, and Compliance Forum on Telehealth. This two-day conference will be packed with comprehensive panel discussions and strategy sessions lead by some of the leading legal and compliance experts in the telehealth industry. Attend and walk away with all the critical updates and key information needed to thrive in the rapidly evolving telehealth industry, while navigating critical compliance pain points.

Registration is now open. We look forward to seeing you in NYC!

Telehealth and telemedicine are rapidly growing and evolving in this post-pandemic era, and so are the legal and compliance challenges —

Distinguished Faculty

CONFERENCE CO-CHAIRS

Thomas Ferrante Partner Foley & Lardner LLP

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

SPEAKERS

Libby Baney Partner Fargre Drinker Biddle & Reath LLP

Melissa Bianchi Partner Hogan Lovells

Roger Cohen Partner Goodwin Procter LLP

Rujul Desai Of Counsel Covington & Burling, LLP

Charles C. Dunham, IV Shareholder Greenberg Traurig, LLP

Jody Erdfarb Partner Wiggin & Dana LLP

Marc Goldsand Partner Goldsand Friedberg

Hilda Gurley Principal Pharmacy Compliance Strategies, LLC

Nicholas Heesters

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

Dan Kagan Attorney DLA Piper LLP, USA

Eugene Karlik General Counsel Charlie Health

Lisa Kechijian Assistant General Counsel Verana Health

Nathaniel Lacktman Chair, Telemedicine & Digital Health Industry Team Foley & Lardner LLP

Tori Lallemont VP & Assistant General Counsel OneMedical

Terrance Lewis General Counsel UPMC

Christopher Logan Senior Vice President and Chief Security Officer Censinet

Dan Logsdon Director National Center for Interstate Compacts

Lisa Mazur Partner McDermott Will & Emery

Brian McEvoy Partner Baker & Hostetler LLP

Michelle McGovern General Counsel Verana Health

Carolyn Metnick Partner Sheppard, Mullin, Richter & Hampton LLP

Carrie Nixon Co-Founder and Managing Partner Nixon Gwilt Law

Lee Nutini Associate Director, Senior Counsel Ro

Michael Petegorsky General Counsel & Head of Public Affairs Mindbloom

Kaytie M. Ravega Partner Quarles & Brady LLP

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

Jeremy D. Sherer Partner Hooper Lundy & Bookman, P.C.

Rebecca Simone Partner Nixon Peabody

Janice Tam VP of Legal & Corporate Secretary Rune Labs

Kristen McDermott Woodrum Partner McGuireWoods LLP

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.

Main Conference - Day One

Wednesday, November 15, 2023

8:45 CO-CHAIRS’ OPENING REMARKS

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

Microphone-alt Thomas (TJ) Ferrante, Partner, Foley & Lardner LLP

Kristi Kung, Partner & Healthcare Regulatory Practice Chair, 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 highlevel exploration of the current and emerging telehealth landscape and the regulatory framework currently governing telehealth practices and services.

Compliance Essentials: Licensing, Credentialing & Scope of Practice

9:15

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

Microphone-alt

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

Credentialing

• 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

10:15 Morning Coffee Break

10:45

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

Microphone-alt Tori Lallemont, VP & Assistant General Counsel, One Medical Lisa Mazur, Partner, McDermott Will & Emery

Michael Petegorsky, General Counsel & Head of Public Affairs, Minbloom

Janice Tam, VP of Legal and 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

11:45 Networking Luncheon

Focus on Direct to Consumer (DTC) Telehealth

1:00

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

Microphone-alt Melissa Bianchi, Partner, 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

2:00

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

Microphone-alt Jody Erdfarb, Partner, Wiggin & Dana LLP

Rebecca Simone, Partner, Nixon Peabody

• 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

3:00

3:15 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

3:45

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

Microphone-alt Christopher Logan, VP & Chief Security Officer, Censinet Carolyn Metnick, Partner, Sheppard Mullin

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

4:45

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

Microphone-alt 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

5:30 Conference Adjourns

Main Conference - Day Two

Thursday, November 16, 2023

8:45

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

Microphone-alt Thomas (TJ) Ferrante, Partner, Foley & Lardner LLP

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

9:00

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

Microphone-alt Libby Baney, Partner, Fargre Drinker Biddle & Reath LLP

Thomas (TJ) 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

10:00

Telehealth Fraud and Abuse: Steering Clear of Potential Violations of False Claims Act and Qui Tam Enforcement

Microphone-alt 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

11:00 Morning Coffee Break

11:15

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

Microphone-alt 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 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

12:15 Networking Luncheon

1:15

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

Microphone-alt 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

2:00 Afternoon Break

2:15

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

Microphone-alt Lisa Kechijian, Assistant General Counsel, Verana Health

Kristi Kung, Partner & Healthcare Regulatory Practice Chair, 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

3:00

Closing Remarks – Conference Ends

POST-CONFERENCE WORKSHOP

Thursday, November 16, 2023

3:15 pm–6:00 pm

The Nuts and Bolts of Launching and Scaling a Telehealth Business: A Master Class on Building a Telemedicine Business While Managing Compliance Pain Points

Microphone-alt Eugene Karlik, General Counsel, Charlie Health

Nathaniel Lacktman, Chair, Telemedicine & Digital Health Industry Team, Foley & Lardner LLP

Jeremy D. Sherer, Partner, Hooper Lundy & Bookman, P.C.

As the scope of telehealth and telemedicine continues to grow in the post-COIVD era, more and more people are looking to establish their own tele-practice, take their practice to the national or international level, or partner with an already established healthcare company. Given the rapidly evolving regulatory landscape, and the fact that telehealth at its core employs meticulously designed and secured protocols and technologies — launching or expanding a telehealth business can be a complicated and intimidating endeavor.

This workshop will provide you with a comprehensive deep dive into the full spectrum of operational considerations needed to break-into and thrive or to expand more practices in the telehealth market, while navigating critical compliance pain points.

Topics will include:

• A step-by-step guide to launching a telemedicine practice or telehealth startup including the basics, such as:

» Considering the choice of entities and incorporation

» Establishing an employer identification number and a national provider identifier

» Certification requirements

» Selecting the appropriate insurance coverage

» Designing the patient-facing front end of your business

» Navigating laws and rules to expedite multistate expansion

• An overview of telehealth operation essentials, including:

» Licensing, enrollment and credentialing requirements

» DEA registration

» Medical billing/reimbursements

» HIPAA compliant audio-video technologies

» Privacy concerns

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Bed Venue Information

Hotel: SpringHill Suites NY Manhattan Times Square South

Address: 338 West 36th Street, New York, NY 10018

Reservations: 1 212-216-9244

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s TeleHealth Compliance”.

Please note that the guest room block cut-off date is October 14, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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Register and pay to lock in your early rate and be eligible for a full refund until November 1, 2023. If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by November 1, 2023.

REGISTRATION CODE: B00-864-864L24.WEB

CONFERENCE CODE: 864L24-NYC

*Team/group registrations must be from the same organization/firm and register together in one transaction.

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