1. The Basics and Trends of Telemedicine Daniel Zinsmaster (614) 628-6949 daniel.zinsmaster@dinsmore.com

2. What is Telemedicine?  Telemedicine  The exchange of medical information from one site to another via electronic communications to improve a patient’s health.

3. Telemedicine vs. Telehealth  Telehealth  Telehealth concerns a broader array of health care and wellness services – beyond medical services – delivered via electronic communications.  Telemedicine vs. Telehealth  Telehealth is an expansion of telemedicine, and whereas telemedicine focuses on the curative aspects, telehealth encompasses preventative and educational aspects as well.  Telemedicine – videoconference between patient and healthcare provider for assessments and history taking.  Telehealth – online provider training and continuing medical education.

4. History of Telemedicine  Began in the early 1960’s with the NASA space program.  Physiological measurements of the astronauts were taken from both NASA spacecraft and space suits.  US Indian Health Service used telemedicine to reach remote reservations in 1970’s.  After 1989 earthquake in Armenia, U.S. enabled one- way international telemedicine network for consultations between Armenia and four medical centers in the U.S.

5. Licensure and Regulation  Practice of medicine is governed by state law.  License to practice generally required in each state where practice occurs.  Practice occurs where the patient is located.

6. Licensure and Regulation R.C. 4731.296(A)  Ohio’s definition of telemedicine – R.C. 4731.296(A)  The “practice of telemedicine” means the practice of medicine in this state through the use of any communication, including oral, written, or electronic communication, by a physician located outside this state.  Who can practice telemedicine  Fully licensed MDs and DOs  Telemedicine certificate

7. Licensure and Regulation – R.C. 4731.296  Essentially the same as if applying for full licensure.  Current, unrestricted license in another state.  Principle place of practice is located in that state.  Sufficient CMEs.  Good moral character and pass criminal background check.

8. Licensure and Regulation – R.C. 4731.296  Telemedicine certificate holder may not physically practice medicine in Ohio.  Per written request, telemedicine certificate can be converted to full MD or DO certificate pursuant to Ohio’s reciprocity statute (R.C. 4731.29).

9. Exception for “infrequent” consultations – R.C. 4731.36(A)(3)  Non-Ohio physician may provide consultation regarding an Ohio patient to an Ohio physician if one of the following applies:  Does not provide consultation in this state on a regular or frequent basis.  Provides the consultation without compensation of any kind.  The consultation is part of the curriculum of a medical school.

10. Licensure and Regulation – Standards of care  The same standards of practice for interaction, treatment, recommendations and prescribing apply regardless of whether services provided via telemedicine or traditional in-person encounters.

11. Licensure and Regulation – Standards of care  Must be able to:  Verify patient’s identity and location.  Disclose and validate provider’s identity and credentials.  Obtain appropriate informed consent.  Facilitate continuity of care.

12. Licensure and Regulation – Standards of care  Many States may require that specific physician services must be provided as a condition precedent to prescribing.  Treatment and prescribing based solely on online questionnaire does not comply with standards of care.

13. Licensure and Regulation – Prescribing  Prescribing when the physician has not personally physically examined and diagnosed is suitable under limited circumstances:  Institutional settings.  On call situations.  Cross coverage situations.  When physician has scheduled or is in process of scheduling an appointment to examine the patient.  Protocol situations.  Situations involving APNs practicing in accordance with a standard care arrangement.  Certain hospice settings.

14. Licensure and Regulation – Prescribing continued  2008 Ryan Haight Act – prohibits the dispensing of controlled substances using the internet without a valid prescription involving at least one in-person medical evaluation.

15. Coverage and Payment – Private Insurers  27 States plus Washington D.C. have enacted “parity” laws requiring health insurers to cover services delivered by telemedicine the same as in-person.  Ohio does not have telemedicine parity law.  Insurers increasingly offering access to telemedicine consults to discourage costly visits to ERs and urgent care.

16. Coverage and Payment – Medicare  Medicare coverage lags behind private payers.  First authorized in 2000 for beneficiaries receiving services at facilities in rural areas.  Coverage for “originating” and “distant” sites:  Originating sites: hospitals; physician offices; critical access hospitals; rural health clinics; federally qualified health centers.  Distant sites: not defined by statute, but CMS has excluded RHCs and FQHCs.  Originating sites receive facility fee, and practitioner at distant site receives professional fee.

17. Coverage and Payment – Medicare  In 2015, only 75 individual service codes covered by Medicare are approved for payment when delivered via telehealth.  Professional consultations.  Office visits.  Office psychiatry services.  Others determined by CMS.  Almost 80% of Medicare beneficiaries not covered because they live in a “metropolitan area”.  No coverage for “store-and-forward” services.  No coverage for services outside of designated health facilities.

18. Coverage and Payment – Medicaid  Similar barriers to coverage, varying greatly from State- to-State.  Rarely cover email, telephone and fax consultations.  See OAC 5160-1-18.

19. Credentialing  Unique issues because covered services involve two or more facilities.  Direct credentialing vs. “credentialing by proxy”.  Credentialing by proxy approved by The Joint Commission and CMS.  Permit originating site hospitals to rely on the credentialing and privileging decisions of distant hospital.  42 CFR 482.22(a)(3)

20. Credentialing – 42 CFR 482.22(a)(3)  Conditions for credentialing by proxy:  Written agreement between originating and distant site hospitals.  Distant site is Medicare-participating.  Distant site practitioner is privileged at distant site hospital.  Distant site hospital provides current list of practitioner’s privileges.  Distant site practitioner is licensed in state where originating site hospital is located.  Review and disclosure of adverse outcomes and complaints.

21. Credentialing  Negligent credentialing concerns.  Bylaws must be reviewed.

22. Medical Malpractice and Professional Liability Insurance  Medical Malpractice  Lack of case law limits ability to develop assumptions about whether there are unique legal risks associated with telemedicine.  Who bears the responsibility?  Insurers likely will assess quality, effectiveness and training.  Practitioners should review policies before providing telemedicine services.

23. Privacy and Records  A physician treating a patient via telemedicine must maintain a complete record of the patient’s care according to prevailing medical record standards.  Special awareness with regard to retention of records for minors.  Must maintain the record’s confidentiality and security consistent with state and federal law.  Availability of records during government review or investigation.

24. Evolving Trends – embracing telemedicine vs. disrupting status quo  Presence in hospitals, home health agencies, private physician offices, consumers’ homes, and workplaces.  Readmission rates decrease for home telemedicine and telehealth participants.  Increased access to rural or socioeconomically disadvantaged.  Inadequate reimbursement and revenue streams stifle investment in telemedicine.  Threat to brick and mortar facilities and practices.  Complex and uncoordinated regulatory landscape.  Acceptance of video vs. audio-only technology.

25. Evolving Trends – Ohio  R.C. 4731.74 (House Bill 64)  Permit a physician to prescribe to a person the physician has never personally examined if certain requirements are met, including examination of the patient using diagnostic medical equipment that can transmit images of the patient's physical condition in real-time.  Permit a physician to examine a patient over the telephone if the patient has a primary care physician, and if the examining physician is in Ohio, is credentialed to provide telehealth services, and forwards the patient's electronic health record to the patient's primary care physician.

26. Evolving Trends – Ohio  R.C. 4731.74 (House Bill 64)  Permit a physician to prescribe or dispense a controlled substance to a person that the physician has never personally examined in limited circumstances.

27. Evolving Trends – Ohio  Governor Kasich used a line item veto to eliminate the proposed R.C. 4731.74 from the budget bill.  State Medical Board of Ohio has issued draft regulations for public comment.  Existing Position Statement on telemedicine.  Existing Interpretative Guidance regarding prescribing to persons not seen by physician.

28. Evolving Trends – Ohio  Senate Bill 32 introduced in 2015 to establish telehealth parity under private insurance and Medicaid.  Would prohibit insurers from excluding coverage for a telemedicine service solely because service is not provided through a face-to-face encounter.

29. Helpful Resources / Websites  American Telemedicine Association (http://www.americantelemed.org/)  American Health Lawyers Association (https://www.healthlawyers.org/Pages/home.aspx)  State Medical Board of Ohio (http://www.med.ohio.gov/Home.aspx)  Federation of State Medical Boards (http://www.fsmb.org/)

30. Questions? Daniel Zinsmaster (614) 628-6949 daniel.zinsmaster@dinsmore.com