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1 3rd Annual Telehealth Summit of South Carolina Your Telehealth Program: Are You Compliant with the Legal and Regulatory Hurdles? What Do You Need to Know to Make Sure You Don t Trip? Greg Billings Executive Director September 25, 2014 Slides may not be duplicated without consent. Copyright 2014

2 Objectives Review legal and regulatory issues facing telehealth practitioners: Licensure Credentialing and Privileging Diagnosing and prescribing of medication Reimbursement

3 CTeL s History CTeL was founded in 1995 to address the legal and regulatory barriers impacting the utilization of telehealth and related e-health services. CTeL, formerly known as the Center for Telemedicine Law, was created under the vision and leadership of: Mayo Foundation Cleveland Clinic Midwest Rural Telemedicine Consortium Texas Children s Hospital Robert J. Waters

4 CTeL s Expertise Physician and Nurse Licensure Requirements Credentialing and Privileging of Practitioners Telemedicine and Internet Diagnosing/Prescribing Medicare, Medicaid, and Private Payer Reimbursement HIPAA Privacy Compliance Referral restrictions and anti-kickback statutes International and Maritime Law Industrial telemedicine

5 Definition of Terms Originating site: the location of the patient during a telemedicine encounter. Distant Site: the location of the specialist providing service during the telemedicine encounter.

6 Telehealth: What is Telemedicine, Telehealth and mhealth Legally? Defined: The use of telecommunications and information technology to provide access to health assessment, diagnosis, intervention, consultation, supervision and information across a distance. Includes telephones, fax machines, electronic mail systems, and remote patient monitoring devices which are used to collect and transmit patient data for monitoring and interpretation. (Source: CMS)

7 Telemedicine: Is the use of medical information exchanged from one site to another via electronic communications. Includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site. (Source: CMS). What is Telemedicine, Telehealth and mhealth Legally?

8 What is Telemedicine, Telehealth and mhealth Legally? mhealth: The practice of medical and public health, supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones and PDAs, for health services and information. Baby Malea

9 Licensure Credentialing and Privileging Sounds Great! Where are the Hurdles? Prescribing of medication without an inperson/face-to-face physical exam Reimbursement Medicare Medicaid Private payers

10 Licensure for Telehealth Where is the patient located? Telehealth practitioners must meet licensing requirements in the state in which they provide services. Where the patient is located... Licensure requirements are different in each state.

11 Physician Licensure All states require medical licensure 10 States have a telemedicine or special licensure process. 46 States require licensure in another locality in order to practice across state lines. Note: Following 2014 state legislative action, CTeL is completing a comprehensive review of all state licensure laws. Numbers subject to change based on final research.

12 Special Telemedicine License Procedure/Special Purpose License 1. Alabama 2. Louisiana 3. Minnesota 4. Montana 5. Nevada 6. New Mexico 7. Ohio 8. Tennessee 9. Texas 10.Wyoming Note: Following 2014 state legislative action, CTeL is completing a comprehensive review of all state licensure laws. Numbers subject to change based on final research.

13 Special Telemedicine License Procedure/Special Purpose License May require other conditions for special license: Maintain a full medical license in another state No ethics violations Must not have an in-state office

14 Licensure: Exceptions Resident in training Border states U.S. Military/VA physicians Public health services Medical emergencies/natural disasters Physicians employed by sports entities Physicians providing care to their patients while temporarily in another state Physician to physician consultation

15 Licensure: Exceptions Infrequent or occasional consultations permitted. All states allow this exception 7 states define occasional or infrequent Delaware: fewer than 12 consults per year New Mexico: no more than 10 patients per year Wyoming: not more than 12 days in any 52 week period. Note: Following 2014 state legislative action, CTeL is completing a comprehensive review of all state licensure laws. Numbers subject to change based on final research.

16 Licensure Consultation Requirements South Carolina An out-of-state licensed physician may consult with a South Carolina-licensed physician regarding the treatment of a patient located in South Carolina. The consulting physician is not permitted to prescribe, treat, operate on, or in any other way, manage the health care of a specific patient. It is the Board's position that an out-of-state physician who renders a primary diagnosis on a patient physically located in South Carolina is practicing medicine, as defined by state law, and must be licensed in South Carolina. South Carolina does not set a maximum number of consultations permitted per year.

17 North Carolina Licensure Consultation Requirements Out-of-state physicians are permitted to provide consultation services to North Carolina-licensed physicians, either in person or by use of electronic mediums, to consult with a resident registered physician or to consult with personnel at a medical school about educational or medical training, provided such consultations occur on an irregular basis. Irregular basis is not defined by North Carolina law.

18 Licensure Consultation Requirements Georgia Licensed physicians of other states and foreign countries are permitted to provide consultative services for a Georgia licensed physician provided the out-of-state physician does not establish offices in the state of Georgia for the practice of his or her profession, or practice under another physician's license, unless he or she obtains a license from the board.

19 Consultation versus Practicing? Can the lines be blurred between consultation and practicing? Is the relationship between the consulting practitioner and the primary practitioner at or near the same level? Or is the consulting practitioner at a significantly different level than the practitioner with the patient? Can the lines be crossed so a consultation is actually practicing medicine without being properly licensed at the originating site?

20 Credentialing and Privileging Original CMS Policy: Required the originating hospital to fully credential and privilege all practitioners, including telehealth practitioners. Joint Commission allowed credentialing / privileging by proxy. 2004: Joint Commission Telemedicine Guidelines JC-accredited facilities could accept credentialing from other JC-accredited facilities System worked unless audited by state or CMS CMS and JC were in conflict. JC had permanent deeming authority

21 Credentialing and Privileging July 5, 2011 credentialing and privileging by proxy is permitted through CMS Final Regulation. Originating Site Hospital can rely on Distant Site for Credentialing and Privileging. Distant Site can either be: Medicare Participating Hospital Telemedicine Entity Written agreement between Hospital and Distant Site.

22 Credentialing and Privileging Hospitals choosing to use this option for credentialing/privileging must provide for the following: The distant-site hospital is a Medicare-participating hospital. The distant-site practitioner is privileged at the distant-site hospital. The distant-site hospital provides a current list of the practitioner s privileges.

23 Credentialing and Privileging Hospitals choosing to use this option for credentialing / privileging must provide for the following: The distant-site practitioner holds a license issued or recognized by the state in which the originating-site hospital is located. The originating-site hospital has an internal review of the distant-site practitioner s performance and provides this information to the distant-site hospital. Information sent from the originating-site to the distant site must include all adverse events and complaints from telemedicine services provided by the distant-site practitioner to the originating-site hospital s patients. Fact sheets at (Credentialing/ Privileging Resource Center

24 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care Physician/Patient Relationship -- Prescribing statutes were written before the widespread use of telemedicine. 42 states require physical exam or a preexisting physician-patient relationship. Problem: Statutes use vague language. Can a face to face or in person examination occur through telemedicine? Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

25 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care 19 states allow for the physical examination to take place electronically (each administered differently) Arizona - Colorado Florida - Georgia Hawaii - Louisiana Maryland - Nevada New Mexico - North Carolina ** Ohio - Oklahoma Rhode Island - Tennessee Texas** - Utah Vermont - Virginia Washington Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

26 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care 30 States require a Patient Medical History before prescribing. 29 States allow for emergency prescribing in specific situations. 36 States specifically prohibit medical questionnaires and/or patient supplied history as sole basis for prescription. Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

27 Telemedicine Diagnosing/Prescribing Requirements South Carolina Prior to prescribing any drug, controlled substance, or other treatment, a physician shall establish a valid practitioner-patient relationship. A valid practitioner-patient relationship shall, at a minimum, require: 1. Personally perform and document an appropriate history and physical examination, make a diagnosis, and formulate a therapeutic plan. 2. Discuss with the patient the diagnosis and the evidence for it, and the risks and benefits of various treatment options 3. Ensure the availability of the licensee or coverage for the patient for appropriate follow-up care.

28 Telemedicine Diagnosing/Prescribing Requirements South Carolina The Board does not recognize an examination through two way, audio video telemedicine as a legitimate method of conducting the required physical examination. South Carolina law specifically notes that prescribing drugs to individuals the licensee has never personally examined based solely on answers to a set of questions is unprofessional.

29 North Carolina Telemedicine Diagnosing/Prescribing Requirements The North Carolina Medical Board has stated that physical examinations conducted before diagnosing and treating need not be in-person if the technology is sufficient to provide the same information to the licensee as if the exam had been performed face-toface. A simple questionnaire without an examination is not valid.

30 North Carolina Telemedicine Diagnosing/Prescribing Requirements A diagnosis should be established through the use of accepted medical practices, i.e., a patient history, mental status examination, physical examination and appropriate diagnostic and laboratory testing. Licensees using telemedicine should also ensure the availability for appropriate follow-up care and maintain a complete medical record that is available to the patient and other treating health care providers.

31 Georgia Telemedicine Diagnosing/Prescribing Requirements Recognizes and regulates the practice of telemedicine. It is the position of the Georgia Composite Medical Board that it is unprofessional conduct for a practitioner to diagnose and treat a patient without conducting a physical examination beforehand. The Board recognizes an examination through two way, audio video telemedicine (incorporating telemedicine peripherals and diagnostic tests, if appropriate) as a legitimate method of conducting that required physical examination.

32 Telemedicine Diagnosing/Prescribing Requirements Georgia Minimum standards of practice via electronic means: Treatment and consultations performed by Georgia-licensed practitioners History of the patient available to practitioner providing treatment via electronic means Georgia-licensed practitioner has either: Personally seen and examined the patient and is providing ongoing care; Is providing care via electronic means at the request of a Georgia-licensed practitioner who has personally seen and examined the patient; or, Is able to examine the patient using technology and peripherals that are equal to or superior to an in person examination with the provider s standard of care. Properly maintain medical records Ensure follow-up care Practitioner must make diligent efforts to examine the patient in person at least once annually.

33 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care CTeL Safe Telemedicine-Safe Medicine Principles Telemedicine is a mechanism to deliver safe, effective healthcare. States should legally recognize an examination through telemedicine technology that provides the practitioner with information equal or superior to an in person examination. A physician-patient relationship can only be established through an examination by tablet, phone app, or web camera if the examination provides information equivalent to an in person exam, conforms to the standard of care expected of in-person care; and if necessary, incorporates peripherals and diagnostic tests sufficient to provide an accurate diagnosis.

34 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care CTeL Safe Telemedicine-Safe Medicine Principles (continued) A physician-patient relationship cannot be established through an examination by telephone (audio-only) or . On call language may not be used by a physician to prescribe for a patient never seen by the physician unless there is an established agreement between the patient s personal physician and covering physician, compliant with state law governing on call relationships between practitioners.

35 Telemedicine/Internet Diagnosing/Prescribing: Standard of Care Telemedicine encounter must conform to the standard of care. Meet or exceed an in person examination, using peripherals and diagnostic tests, when necessary. Can an examination through one of these mediums conform to the standard of care? Can a practitioner: Look into a patient s mouth using a web cam or phone app and a smart phone flashlight and accurately diagnose strep? Talk to a patient over the telephone or web cam and diagnose a UTI or an ear infection? Use a phone app to diagnose conjunctivitis? Diagnose breast pain through a web portal?

36 Problems? Antibiotic Overprescribing JAMA study on evisits for UTI: 99% presenting through evisit received antibiotic. 49% presenting in-person received antibiotic. CDC presentation on CTeL Webinar: 10% of adults present with strep; 30% of children Diagnostic tests only way to confirm strep or UTI.

37 Problems? When somebody gets hurt through a misdiagnosis because exam isn t equal or superior to an in person exam... Media won t center on the practitioner who didn t conform to the standard of care. Headline will be: Baby gets hurt though telemedicine. If the regulatory process is tough now, wait for that fallout.

38 Problems? Antibiotic Overprescribing If you can think of it, somebody s doing it. Or if they aren t, they will be doing it soon. (State Medical Board CMO) CTeL urges states to take on the challenge of highlighting what goes into good, safe medicine. What goes into good, safe medicine is what goes into good, safe telemedicine.

39 Problems? Misdiagnosis Medicare Statute Originating sites in certain locations Covered procedures specified with codes Specific practitioners eligible In 2013, Medicare reimbursed approximately $11.8 million under the Medicare Physician Fee Schedule Medicaid 45 states cover certain telehealth services.

40 Telehealth Reimbursement 22 States (and the District of Columbia) mandate private payer telehealth coverage. Arizona -California -Colorado Georgia -Hawaii -Kentucky Louisiana -Maine -Maryland Massachusetts -Missouri -Michigan Mississippi -Montana -New Hampshire New Mexico -Oklahoma -Oregon Texas -Vermont -Virginia District of Columbia -Tennessee

41 So, Now You Know About the Hurdles... The concrete black and white answers may not exist. You may think the statute or rule is stupid Your opinion doesn t count! Seriously, your input on what it should say does count! Incorporate the legal and regulatory questions into your business model at the beginning, not the end. The legal and regulatory problems won t just go away if you don t address them. They only get worse.

42 Contact Information Greg Billings Executive Director Robert J. Waters Center for Telehealth and e-health Law P.O. Box Washington, D.C

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