Nathaniel Lacktman, Esq. @Lacktman Legal and Business Issues in Telehealth: Offering Services in Michigan and Beyond Nathaniel Lacktman, Esq. @Lacktman June 8, 2017

Telehealth Sources of Revenue Government FFS (Medicare, Medicaid) Cost Savings and Cost Avoidance Medicare Advantage, Medicaid MCOs Telehealth Sources of Revenue Self-Pay / Cash Commercial Health Plans Institutions, Providers Employer Self-Funded Plans Employer Pay (OOP)

Telehealth: Think Bigger

Services + Credentialing Payment + Reporting Originating Site Distant Site Services + Credentialing

Originating Site Services Recurring FFS Distant Site

Statewide Telemedicine Network

Nationwide Destination Medicine Center

International Telemedicine Arrangements

Legal & Regulatory Considerations

Telemedicine State Practice Standards New Patient vs. Established In-Person Exam Originating Site Restrictions Patient-Site Telepresenter Modality of Communication Technology Remote Prescribing (incl. Controlled Substances) Record-Keeping and Record-Sharing Informed Consent Patient Choice of Provider Disclosures Malpractice & Professional Insurance Considerations Credentialing Michigan Consent? yes In-person exam? no Prescribing and CS? yes Available for follow-up care? yes Records? No Modality? “Telemedicine” is defined as the use of an electronic media to link patients with health care professionals in different locations. The health care professional must be able to examine the patient via a real-time, interactive audio or video, or both, telecommunications system and the patient must be able to interact with the off-site health care professional at the time the services are provided.

Beyond In-Person Exams U.S. Federal Anti-Kickback Statute Physician Self-Referral Civil Monetary Penalty Law Payer Rules (including Medicare, Medicaid) HIPAA & HITECH FTC, FDA, DEA Credentialing U.S. State Patient Brokering Acts Fee-Splitting Laws Self-Referral Laws Corporate Practice of Medicine Insurance Laws eCommerce Considerations Privacy & Security International Foreign Corrupt Practices Act US Export Control Laws US Anti-Terrorism Laws US Anti-Boycott Laws International Corporate Laws and Tax Data protection; data ownership; record sharing Intellectual Property

One Law Firm. All Your Digital Health Needs. Nathaniel Lacktman, Esq. Partner Chair, Telemedicine Industry Team Co-Chair, Digital Health Group 813.225.4127 nlacktman@foley.com www.foley.com/telemedicine www.healthcarelawtoday.com @Lacktman Telemedicine ● Telehealth ● Virtual Care ● mHealth Fraud and Abuse ● Regulatory Compliance ● International/Destination Medicine Reimbursement and Payment ● Contracting and Joint Ventures ● M&A Licensure and Practice ● Concierge Medicine ● Privacy and Security

Thank you