Alternative Practice Model: Telemedicine in Texas

1. Alternative Practice Model: Telemedicine in Texas Alyssa Parrish Attorney and Vice President of Business Affairs RediClinic, LLC Phone: 713-822-0023 Email: alyssa.parrish@rediclinic.com

2. Definition: Tele-what? • Telehealth: • means a health service, other than a telemedicine medical service, delivered by a . . . health professional acting . . . that requires the use of advanced telecommunications technology, other than by telephone or facsimile, including: (i) compressed digital interactive video, audio, or data transmission; (ii) clinical data transmission using computer imaging by way of still-image capture; and (iii) other technology that facilitates access to health care services/medical specialty expertise. • Telemedicine: • the practice of medical care delivery, initiated by a distant site provider, who is physically located at a site other than the site where the patient is located, for the purposes of evaluation, diagnosis, consultation, or treatment which requires the use of advanced telecommunications technology that allows the distant site provider to see and hear the patient in real time. With CMS’ final rule provided, most entities are focused on reimbursement. Forget about being paid, can your client even engage in telemedicine? • 22 Tex. Admin. Code §174.2(11).

3. Outline/Objectives I. The Ground Rules • Who can treat? • How can you treat? • What can you treat? II. Privacy/Security Concerns • Technology Vendor Considerations • Patient Safety/Security II. Protection • Updating Policies and Procedures • Insurance Considerations

4. Is your client geographically challenged? Achieving an Out-of-State Telemedicine License Checklist Age: 21+ years of age Actively Licensed: Actively licensed to practice medicine with another state Previous/Current Actions: Not the recipient of a previous disciplinary action/pending investigation by any other state or jurisdiction; Currently Certified: Certified by the American Board of Medical Specialties* within the ten (10) years prior to date of applying for licensure; Application/Fee: Complete a board-approved application for an out-of-state telemedicine license for the practice of medicine across state lines and submit the requisite initial fee 22 Tex. Admin. Code §172.12(A)(1) - (7)

5. Achieved an Out-of-State Telemedicine License; Now What? • Renew and Retain License • See 22 Tex. Admin. Code§166.1 • Practice is EXCLUSIVE to the following: • interpretation of diagnostic testing/reporting results to a fully licensed Texas physician OR • for the follow-up of patients where the majority of patient care was rendered in another state • License Holder shall comply with Texas’ laws/regulations concerning practice of medicine 22 Tex. Admin. Code §172.12(c)

6. Who/What can your Client Treat Via Telemedicine? • Patient arrives at Electronic Medical Site (enough diagnostic equipment for physical) • Distant Site Provider (physician/NP/PA) can evaluate patient through telemedicine with the help of Patient Site Presenter (licensed or certified healthcare provider) • * Services performed must be within the scope of Patient Site Presenter Two Models for Telemedicine in Texas Current Legal/TMB landscape 22 Tex. Admin. Code § 174.1 et al Model One: Established Medical Site (EMS) Model Two: Patient’s Home 1st Hurdle: Who can the Distant Site Provider treat? • F/up for pre-exiting conditions EXEPT no scheduled drugs for chronic pain • NEW symptoms: • treat patients at home for up to 72 hours as long as the patient is advised to see a physician in a face-to-face visit within 72 hours if the symptoms do not resolve • If f/up does not occur, Distant Site Provider must cease teleconference treatment • Pre-existing patient who had a face-to-face visit either by the Distant Site Provider with whom the patient is teleconferencing OR • Been treated by another physician who (i) has referred the patient to the Distant Site Provider providing telemedicine care AND (ii)referral is documented in the medical record • Must see patient in-person at least once a year 2nd Hurdle: What can the Distant Site Provider treat?

7. Other Notable Changes • Expansion of Face-to-Face Visit definition • Definition: • An evaluation performed on a patient where the provider and patient are both at the following: • same physical location OR • where the patient is at an Established Medical Site • Why is this important? • A distant site provider can use an established medical site to create a patient/clinician relationship AND • Then use that relationship as the basis for having a pre-existing relationship for telemedicine within a patient’s home • The patient/distant site provider will still need to have an annual, in-person visit

8. Outstanding Concerns of the Who/What? • Can a Distant Site Provider see a patient at a non established medical site via telemedicine if a non-physician (NP/PA) referred? • In May 2011, a TMB member “unofficially” confirmed that it must be a physician that refers • Warning: • Electronic treatment, consultation (including prescription) will be held to the same standard of care as an in-person clinical settings • Static Questionnaire will not suffice as a telemedicine visit • Distant site providers must obtain a complete medical history for the patient PRIOR to providing treatment and must document this in the medical record • Health Information Exchange

9. II. Privacy/Security Concerns Technology Vendors Consideration • Is the vendor HIPAA HITECH compatibility? • For example: How will it detect breaches? • Is the vendor PCI compliant (assuming payment is occurring)? • Can it abide with Board Rules/Texas’ law/regulations?* • How does it ensure Privacy? Access Controls? • Can it record Informed Consent? • Where is telemedicine video/record stored? And for how long? • Consider Record Retention requirements • How does the vendor confirm a patient’s identity/demographics? • How does it interface with an EMR? Insurance Verification? -------------------------------------------------------------------------------------------- SIDE NOTE: In its “Telemedicine FAQs”, the TMB recommends Skype as a means for videoconferencing • Is Skype compatible with HIPAA? * TEX. OCC. CODE § 111.002, 111.003, 111.004; 22 TEX. ADMIN. CODE §§ 174.3, 174.4, 174.5

10. Board Rules: Privacy & Safety • Notice of Privacy Practice • Prior to telemedicine conference, notice must be given on: • the risks/benefits of being treated via telemedicine, and • how to receive follow-up care or in the event of an adverse reaction to the treatment or equipment failure • Patient Safety Concerns • Establishing that the person requesting the treatment is in fact whom he/she claims to be • Normal SOAP must be conducted and information gathered should be shared with patient • Ensuring the availability of the distant site provider or coverage for appropriate follow-up care 22 Tex. Admin. Code §174.5(a)(1) 22 Tex. Admin. Code §174.4(a)(1)-(4)

11. Board Rules: Security & Storage • Proper security measures must be taken to ensure all patient communications, recordings and records remain confidential • Written policies/procedures must be maintained and updated as necessary. Such policies and procedures must address: • privacy to assure confidentiality and integrity of patient-identifiable information • who will process messages and f/up communication • types of transactions that will be permitted electronically • archival and retrieval • quality oversight mechanisms • All relevant patient-physician e-mail, as well as other patient-related electronic communications, must be stored and filed in the patient's medical record. 22 Tex. Admin. Code §174.9(a)- (c)

12. Board Rules: Medical Record Retention Requirements • Both the distant site provider and the patient site presenter must maintain the records created at each site unless the distant site provider maintains the records in an electronic health record format • Medical records must include copies of all relevant patient-related electronic communications, including relevant patient-physician e-mail, prescriptions, laboratory and test results, evaluations and consultations, records of past care and instructions • If possible, telemedicine encounters that are recorded electronically should also be included in the medical record 22 Tex. Admin. Code §174.10(a) – (c)

13. Insurance/Internal Policies Consideration • Professional liability coverage for distant site provider/patient site provider • Cyber coverage • Internal Procedures/Policies • Clinical Policies/Guidelines updated to ensure SOC is met for e-visits • Ensure scope of practice for Patient Site Provider/Distant Site Provider is firmly established • Update Peer Review Policies/Guidelines • Ensure job descriptions (licensing concerns), credentialing, conducting a telemedicine visit, storage of telemedicine visit/record retention are all reviewed and updated • D&O coverage