Alex Krouse, JD, MHA Christine Wernert, MBA, CPMA

1. Understanding the Implementation and Compliance Issues Concerning Telemedicine“What Legal and Regulatory Issues Should We Know?” Alex Krouse, JD, MHA Christine Wernert, MBA, CPMA

2. Telehealth vs. Telemedicine vs. Telecommuting • What do these terms mean? • Differences between services • Differences in provider contracts, equipment, EPs • Differences in payments

3. Licensure of Professionals • Are patients located in the State? • Are all practitioners located in the same State? • Licensing requirements must be met in the State in which services are provided – Location of Patient • Be aware of licensure issues for border providers

4. Credentialing of Professionals • Originating Site Hospital can rely on Distant Site for credentialing matters. • Written Agreement • Confidentiality • Ownership of Records • Distant Site Requirements • Medicare Participating Hospital or Ensures Medicare Compliance • Practitioner is Privileged at Distant Site • Distant Site Provides Current list of All Privileges

5. Prescribing A documented patient evaluation, including history and physical evaluation adequate to establish diagnoses and identify underlying conditions or contraindications to the treatment recommended or provided, must be obtained prior to providing treatment, including issuing prescriptions, electronically or otherwise. 844 IAC 5-3-2

6. Prescribing Except in institutional settings, on-call situations, cross-coverage situations, and situations involving advanced practice nurses with prescriptive authority practicing in accordance with standard care arrangements, as described in subsection (d), a physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any controlled substance to a person who the physician has never personally physically examined and diagnosed . . . unless the physician is providing care in consultation with another physician who has an ongoing professional relationship with the patient, and who has agreed to supervise . . . 844 IAC 5-4-1

7. Malpractice Concerns • Malpractice Still an Issue! • Physician Patient Relationship • What are the requirements? • Multiple Physicians? • Patient Abandonment • Informed Consent • Provide Choice of Traditional vs. Telemedicine • Practitioners coverage online • Hub site coverage

8. Non-Physician Providers • 180,233 Nurse Practitioners • 3,000+ in Indiana • 83,466 Physician Assistants • 397,130 Primary Care Physicians • Pediatrics – 70,967 • OBGYN – 45,043 • Family Medicine – 116,933 • Internal Medicine - 164,187 • 2020: Shortage of 91,500 Physicians Including 45,000 Primary Care Physicians • Source: Assoc. of American Medical Colleges

9. Non-Physician Providers • Nurse Practitioners/PAs • Supervision or Collaboration? • NP = Collaboration • PA = Supervision • Scope of Practice • Incident to billing • Who are we billing under?

10. Anti-Kickback Risks • Under the Anti-kickback Statute it is illegal to knowingly or willfully: • offer, pay, solicit, or receive remuneration; • directly or indirectly; • in cash or in kind; • In exchange for; • referring an individual; or • furnishing or arranging for a good or service; and • for which payment may be made under Medicare or Medicaid.

11. Anti-Kickback Risks • Is the Government Focused on Telemedicine? • Office of Inspector General Guidance • Case Law • United States vs. Greber • United States v. Polin • Safe Harbors • EHR Donations

12. Stark Law Risks • The Stark Law prohibits a physician from making a Referral • To an entity • For the furnishing of a designated health service • For which payment may be made under Medicare • If the physician (or an immediate family member) • Has a financial relationship with the entity

13. Stark Law Risks • Strict Liability • Stark Law Applies to ANYTHING of VALUE – NOT $$$ Only • How does the Stark Law impact telemedicine? • EHR Exceptions • Rural Exception • Analyze Every Arrangement!

14. False Claims Act Risks • Generally a false/fraudulent claim/statement made or caused to be made for payment to the United States, 31 U.S.C. § 3729(a) • Includes conspiracy and “reverse” false claims provisions • Claim must be submitted “knowingly” • Actual knowledge • Deliberate ignorance • Reckless disregard • No specific intent to defraud required

15. Indiana Medicaid • Medical necessity in every clarification of reimbursed services • Behavioral Health – rapid expansion • 15 states require tele-health reimbursement to be same as face-to-face (IN not one of them) • IHCP does reimburse for consultations, outpatient E/M, behavioral health, MTM, and end stage renal disease services • 20 miles from hub and spoke • No home care reimbursement

16. Implementation Concerns • Area serving a HPSA? • Security and HIPAA • Who and where is the patient and how am I sure? • Reimbursement for interactive services • Modifier codes • Reporting with documentation! • EHR concerns and things to watch out for

18. Take-aways on Indiana • What to tell health care professional looking to implement a tele-health plan • Legislature to watch for on state/federal level • Access of care and patient services in remote areas – increase quality and access • PQRS! • New technologies and policies for implementation to be on look out for • Ensure there are processes in place for licensure and credentialing of professionals • Educate providers on the practical concerns related to malpractice • Analyze every new telemedicine arrangement, from the onset, from a fraud and abuse perspective

19. Alex T. Krouse, JD, MHAAttorney Krieg DeVault LLP 574-485-2003 akrouse@kdlegal.com Christine Wernert, MBA, CPMAPresidentPractice Management Solutions, LLC317-410-2010 wernert.pmsolutions@gmail.com