Telemedicine in Michigan: Overview and Update - 2016

1. TELEMEDICINE IN MICHIGAN OVERVIEW AND UPDATE - 2016 Louis C. Szura, Esq. Health Care Law & Business Attorney September 29, 2016

2. Evolution of Telemedicine ““Adapt or perish, now as ever, is nature’s inexorable imperative.” – H. G. Wells Many rules and regulations regarding the practice of medicine were drafted long before telemedicine. The laws are slowly changing, but they have lagged behind the changes in society. Therefore, there is uncertainty applying old rules to new technology.

3. Difference in Terms

4. Telehealth v. Telemedicine • Telehealth= “’Telehealth’ means the use of electronic information and telecommunication technologies to support or promote long-distance clinical health care, patient and professional health-related education, public health, or health administration. Telehealth may include, but is not limited to, Telemedicine.” MI H.B. 753 9/20/16. • Telemedicine = “Telemedicine” means “the use of an electronic media to link patents 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.” MCL 500.3476(2); MCL 550.1401k(2).

5. Types of Telemedicine

6. Know the Technology • Store and forward • Emails and text messages • Remote Patient Monitoring (glucose, etc.) • Mobile Health (wearables/apps) • Online Forms • Live and Interactive • Telephone • Video conferencing • Cloud Visit, eVisit, SnapMD

7. 2013 MI Senate Bill 1096 • One year after defining “telemedicine,” a bill was introduced to re-define it • Currently limited to live and interactive conferencing and bill intended to expand to other technology • Store and forward may need to be discussed in the future - 2015 MI SB 495

8. Benefits • Reduced Cost • Access to Care • Patient preferences • Improved care?

9. Drawbacks • Time • Data breach risks • Unsettled legal issues • Patient relationship and retention

10. Overview of the Basics • Licensing/Professional Regulations • Licensure • Patient Encounter Requirements • Physician Practice Standards • Informed Consent • HIPAA/HITECH • Appropriate Security/Technology • HIPAA and Privacy Concerns

11. The Basics – Cont. • Reimbursement • Medicare/Medicaid • Private Insurance • Other Issues • Malpractice Policies • Standard of Care • Credentialing/Privileging • Technology Requirements

12. Licensure Provider must be licensed or authorized in the State in which patient is located (originating site) Medical service occurs in State where “patient is located.” MCL 500.3476. Other states have similar provisions Must review state law where patient is located

13. Other State Licensure Rules • Most states explicitly or implicitly require a full license for telemedicine • Some states have general guidance on broadly defined cross-border services (e.g., radiology), or certain licensure exceptions, which might encompass telemedicine • A few states provide for a special purpose license for telemedicine • Some states allowing expedited licenses • State by State Summary: American Telemedicine Association 2016 (http://www.americantelemed.org/policy/state-policy-resource-center#.V-QhSq250ZJ)

14. Keeping Current • ATA - July 14, 2016: Tracking 40 different bills in 29 different states concerning major telemedicine issues (e.g., reimbursement, standards, encounters, etc.) • FSMB - Sept. 22, 2016: 244 proposed bills across the country that refer to practice of telemedicine. • 16 Federal Bills • 2016 CONNECT for Health Act – Expand Medicare Reimbursement • Licensing Board Decisions/Positions

15. Licensure Variations Full License Required • Most states speak directly to telemedicine and require a full, unrestricted license • E.g., California, Colorado, Florida, Georgia, Illinois and Michigan • Protect residents and regulate care

16. Licensure Requirements Michigan: “Telemedicine services must be provided by a health care professional who is licensed, registered, or otherwise authorized to engage in his or her health care profession in the state where the patient is located.” MCL 500.3476.

17. Michigan Licensure Michigan: • An individual shall not engage in the practice of medicine or practice as a physician's assistant unless licensed or otherwise authorized by this article. MCL 333.17011(1). • "Practice of medicine" means the diagnosis, treatment, prevention, cure…. by attendance, advice, device, diagnostic test, or other means, or offering, undertaking, attempting to do, or holding oneself out as able to do, any of these acts. MCL 333.17001(f). • However, Michigan authorizes exception for peer-to-peer consultation under certain conditions. MCL 333.16171(e).

18. Licensure Variations – Special Purpose License Allowed • Some states allow a special purpose or conditional license for telemedicine • e.g., Louisiana, Maine, Minnesota, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas • Alabama and Montana recently rescinded

19. Telemedicine Licenses Texas: Requirements, among other things, include: • Actively licensed in another state without any disciplinary actions • Not be under any government investigations • Board Certified Specialist • Pass the Texas Medical Jurisprudence Examination Limits • Limited to the interpretation of diagnostic testing and reporting results to a physician fully licensed and located in Texas… or for the follow-up of patients where the majority of patient care was rendered in another state • Cannot physically practice medicine in the state of Texas • In-person encounter or another physician there (current dispute)

20. Special Licenses • Strict structure = (Similar to Texas) higher standard of physician background, limit practice to certain circumstances and in-person meeting requirements • Most lenient = Minnesota does not require physicians to obtain an actual license to practice medicine across state lines so long as physician is licensed without restriction in his home state, registers annually with the Minnesota board of Medicine, and pays a registration fee

21. Federation of State Medical Boards (FSMB) • FSMB is a national non-profit representing 70 medical and osteopathic boards of the United States and its territories • Subsidiary Workgroup - State Medical Boards’ Appropriate Regulation of Telemedicine (SMART)

22. FSMB Recommendations State Rights v. National Scope FSMB proposed the Interstate Medical Licensure Compact Expedited licensure among member states Adopted by 17 states and growing: Alabama, Idaho, Illinois, Iowa, Minnesota, Montana, Nevada, New Hampshire, South Dakota, Utah, West Virginia, Wyoming, Colorado, Kansas and Mississippi, Arizona and Wisconsin Proposed bills pending in two states: Pennsylvania and Michigan

23. Licensure Compact • Possess a full and unrestricted license to practice medicine in another compact state • Possess specialty certification or specialty certificate • Have no discipline on any state medical license • Have no discipline related to controlled substances • Not be under investigation by any licensing or law enforcement agency • Have passed the USMLE or COMLEX (or equivalent) within 3 attempts • Have successfully completed a graduate medical education (GME) program

24. Michigan House Bill 4582 • Adopts a version of the Compact • February 2016 – Passed by MI House • Pending in Senate Committee on Health Policy

25. Enforcement of License Requirements • Difficult to Enforce • Provider’s state primarily concerned about protecting its own citizens and may leave prosecution to patient’s state • Patient’s state has little control over out of state physician and difficult and expensive to try to extradite the provider

26. Enforcement • Relatively rare despite the drastic increase in telemedicine • Usually related to a “bigger issue” • 2009 - California sentenced Colorado physician for the act of prescribing Prozac to Stanford student online • He never met patient. No relationship at all • Provider was not allowed to prescribe, even in CO • The student had committed suicide while on the prescription • December 2014 - Pennsylvania court found against a psychologist located in Israel who held himself out as practicing in Pennsylvania. • Used a physical Pennsylvania address on his website • Fined and prohibited from holding himself out as a Pennsylvania psychologist

27. Physician Patient Encounter • Initial face-to-face Meeting • Originally recommended by FSMB • Originally general consensus of professional associations • Standard of Care Issue

28. Initial Face-to-Face Meeting • American College of Physicians Position: • “A telemedicine encounter itself can establish a patient–physician relationship through real-time audiovisual technology.” - Nov. 2015 • Texas /Teledoc – Anti-trust case 2016 (FTC) • Arkansas and Missouri allow - June 2016 • Some states allow, but with conditions imposed

29. Face-to-Face Michigan: (1) An insurer that delivers, issues for delivery, or renews in this state a health insurance policy shall not require face-to-face contact between a health care professional and a patient for services appropriately provided through telemedicine, as determined by the insurer. Telemedicine services must be provided by a health care professional who is licensed, registered, or otherwise authorized to engage in his or her health care profession in the state where the patient is located. MCL 500.3476(1); see also MCL 550.1401k(1)(1).

30. Standard of Care v. Law • Many states that allow initial telemedicine encounter place limits or require physical follow up later • Non-statutory responsibilities • Many states issue physician practice standards for telemedicine in their state • Often e-Prescribing

31. Informed Consent • While it has always been a good practice, many states require written or oral consent • Nineteen states and DC have informed consent requirements • Michigan does not…. yet?

32. Michigan Senate Bill 753 • Requires consolation or patient consent to “telehealth” services • Specifically allow prescriptions via telehealth, but not controlled substances • Allow LARA to promulgate rules and discipline for violations • Passed by Senate; House vote soon

33. Technology/Privacy • Same Security Rule safeguards as other ePHI • BA if the technology is pure “conduit of information” and there is no storage, but, not likely… • If state law of privacy is more restrictive than HIPAA, it applies • For example, California law applies HIPAA standards even if not a CE and not storing information, such as an app developer. CCMIA 2015. • FDA/FTC regulations may apply (mHealth) if not CE • Treat as any other ePHI and ensure BAA, encryption, safeguards, training, monitoring, update NPP, etc.

34. Technology Privacy/Security • Verification • Ensure Confidentiality • Security/Encryption (Federal Information Processing Standard 140-2 or Advanced Encryption Standard) • Password-protected and encrypted devices • No notification of when online, disable “party line” • Up to date security software, per manufacturer • Seek secure transmission (password protected Wi-Fi) • Ensure fast and consistent connection • Have a backup plan • HHS – Two HIPAA settlements (2012 group, 2015 hospital) using web-based software without safeguards

35. Beyond HIPAA Compliant Technology • NPP and Consent • Training • Add telehealth technology training to HIPAA compliance manuals and training • Ensure employees are not sharing passwords • Encrypt all mobile devices • Monitoring • Add remote swipe software?

36. Michigan Medicaid Reimbursement • Among other things, Medicaid reimburses for the following via telemedicine: • Inpatient/Outpatient consults • Outpatient services • Psychiatric diagnostic procedures • Training services, diabetes • End stage renal disease (ESRD) related services • Behavior health and/or substance use disorder treatment

37. Medicaid Reimbursement • Authorized Originating Site (Beneficiary location): • County mental health clinic or publicly funded mental health facility • Federally-Qualified Health Center (FQHC) • Hospital -- either inpatient, outpatient or a critical access hospital (CAH) • Office of a physician or other practitioner (includes medical clinics) • Rural Health Clinic (RHC) • Skilled Nursing Facility • Tribal Health Center (THC)

38. Michigan Medicaid Reimbursement • Must use GT modifier for telemedicine services • In 2013, removed distance requirements for telehealth services • Approximately 2.5 Million Medicaid beneficiaries in Michigan • Approximately 60 different codes reimbursed for telemedicine • Medicaid appears to be most common payer, aside from cash

39. Medicare Reimbursement • Continues to Expand • For example: • In 2015, CMS added seven new reimbursable services, including Psychotherapy and family psychotherapy services • In 2016, CMS will add eight new reimbursable services, including ESRD and advances care planning services

40. Medicare Reimbursement • Common Limitation: • Service must be provided to an eligible Medicare beneficiary in an eligible facility (originating site) located outside of a Metropolitan Statistical Area • 2014 changes also expanded that to Health Professional Shortage Area (HPSA) in rural census tracts within urban areas • Otherwise similar provisions to Medicaid reimbursement in Michigan (authorized originating site, live and interactive, must use GT modifier, etc.) • Next Generation ACOs look to remove some of these barriers, such as the originating site requirement

41. Private Payer Reimbursement • Carrier by carrier policies (BCN June 2016) • Carrier approved programs and technology may be required • May have a distance or location requirement • However, MCL 550.1401k(1) prevents insurance carriers from requiring a face-to-face meeting for reimbursement • Has it expanded coverage?

42. Credentialing & Privileges • Two methods for originating site credentialing • “Full blown” credentialing by originating site • Originating site may rely upon credentialing information from another Joint Commission accredited facility • Regardless, the distant-site practitioner still must have a license that is issued or recognized by the originating site state

43. Credentialing & Privileges Joint Commission requires that organizations credential and privilege providers who “diagnose or treat patients via telemedicine link.” Standard MS.13.01.01 For originating sites only: Licensed independent practitioners who are responsible for the care, treatment, and services of the patient via telemedicine link are subject to the credentialing and privileging processes of the originating site. (http://www.jointcommission.org/assets/1/6/Revisions_telemedicine_standards.pdf) CMS CoP - 42 USC 482.22 (written agreement, etc.)

44. Malpractice Coverage • Often covers only “face-to-face” encounters within the state in which the doctor practices and is licensed • Some carriers cover claims for medical services only in the state • Carrier – itself – may not be licensed in the other state • Controlled by policy language • Special rider may be necessary

45. Malpractice Coverage • Malpractice policy applications now ask what percentage of your practice is telemedicine and where those patients are located if out of state • Insurance company needs to be licensed there and meet the limit and language requirements of that state • Definition of “Professional services” may be medical or other services “in accordance with any required license” and the insurance coverage may only extend to “…..engaged in performance of Professional Services that they hold any required license to perform” • Data breaches concerns – additional coverage

46. Other General Considerations • Tele-health may not be for every patient • Considerations may include: • Patient expectations • Patient’s ability to operate technology in private • Distance for patient to nearest provider or emergency facility • Risk of patient problems when provider is not around • Professional specialty society/organization guidelines

47. Other General Considerations • Consider physical environments at both ends of video/interactive system, such as lighting, seating, etc. • Consider collaboration with clinical team located near patient • Emergency Management Protocol • Up-to-date emergency education and training • Be aware of duty to notify laws and involuntary hospitalization laws in location of patient (mental health services) • Secure contact information for local emergency facility, family member and/or professionals • Consider transportation options in even of an emergency • Document everything (set-up, technology, times, contact, back-up, etc.) with the patient, including informed consent to the telemedicine procedure

48. Utilization Still Low • Despite increase of availability and reimbursement, usage still low • Why? • License confusion • Reimbursement restrictions • Other • Patient access to sufficient technology • Utilization of health care services weighted towards older population • Lesser personal relationship • Time to learn/cost

49. TELEMEDICINE IN MICHIGAN OVERVIEW AND UPDATE - 2016 Louis C. Szura, Esq. Health Care Law & Business Attorney September 29, 2016