Virginia Telemedicine Law: 17th Annual Virginia Health Law Legislative Update Joseph P. McMenamin, MD, JD McMenamin Law Offices 804.921.4856 6/3/15 1
Disclaimer The views expressed here are my own, and not necessarily those of VBA, nor of any of its members, nor of any client of either McMenamin Law Offices or of my consulting firm, MDJD, LLC, nor of anyone else. No copyright is asserted with respect to any material of governmental origin, nor to any clip art. 2
Legal Issues Licensure Credentialing and privileging Privacy/security HIPAA/HITECH State laws Online prescribing Reimbursement FDA Fraud and abuse AKS Stark FCA FTC Tort liability: Professional Product FCC 3
The status quo ante: Virginia Telemedicine Law Office of Telework Promotion and Broadband Assistance, office of the Secretary of Technology Director s duties: Advocate for, and facilitate the development and deployment of, applications, programs, and services including, but not limited to telework, telemedicine, and e- learning that will bolster the usage of and demand for broadband level telecommunications. Va. Code 2.2-225.1 Parity: Va. Code 38.2-3418.16 (next slide) NPs: Collaboration and consultation among nurse practitioners and patient care team physicians. Va. Code 54.1-2957. 4
Va. Code 38.2-3418.16: Parity [E]ach insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis and each HMO providing a health care plan for health care services shall provide coverage for the cost of such health care services provided through telemedicine services, as provided in this section. About half the states have similar legislation 5
2015 Developments 6
Defining TM for Coverage 2015 Session TM: use of electronic technology or media, including interactive audio or video, for the purpose of diagnosis, consultation, diagnosing or treating a patient, consulting with other health care providers regarding a patient's diagnosis or treatment. Telemedicine services does not include an audio-only telephone, electronic mail message, facsimile transmission, or online questionnaire. HB NO. 2063, amending Code 38.2-3418.16 (parity) 7
Virginia Code 54.1-3303. Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only 8
Prescribing: Old Hat A. A prescription for a controlled substance may be issued only by a practitioner authorized to prescribe controlled substances The prescription shall be issued for a medicinal or therapeutic purpose and may be issued only to persons or animals with whom the practitioner has a bona fide practitioner-patient relationship. Code 54.1-3303 Key: Practitioner-patient relationship (next slide) 9
Prescribing, Old Hat 2 [A] bona fide practitioner-patient-pharmacist relationship is one in which a practitioner prescribes, and a pharmacist dispenses, controlled substances in good faith to his patient for a therapeutic purpose [A] bona fide practitioner-patient relationship means that the practitioner shall: (i) ensure that a medical or drug history is obtained (ii) provide info to the patient about the benefits and risks (iii) perform or have performed an appropriate exam either physically or by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically; and (iv) initiate additional interventions and follow-up care, if necessary, especially if a prescribed drug may have serious side effects. 54.1-3303 10
Prescribing, TM, New Hat For the purpose of prescribing...via telemedicine a prescriber may establish a bona fide practitioner-patient relationship by an examination through face-to-face interactive, two-way, real-time communications services or store-and-forward technologies when all of the following are met: (a) the patient has provided a medical history ; (b) the prescriber obtains an updated medical history ; (c) the prescriber makes a diagnosis ; (d) the prescriber conforms to the standard of care expected of in-person care including when the standard of care requires the use of diagnostic testing and performance of a physical examination, which may be carried out through the use of peripheral devices ; 54.1-3303, 2015 Session 11
Prescribing, TM, New Hat, 2 (e) the prescriber is actively licensed ; (f) if the patient is a member or enrollee of a health plan or carrier, the prescriber has been credentialed by the health plan or carrier and the diagnosing and prescribing meets the qualifications for reimbursement ; and (g) upon request, the prescriber provides patient records in a timely manner Nothing in this paragraph shall permit a prescriber to establish a bona fide practitioner-patient relationship for the purpose of prescribing a Schedule VI controlled substance when the standard of care dictates that an in-person physical examination is necessary for diagnosis. 12
Prescribing, TM, New Hat, 3 Nothing in this paragraph shall apply to: (1) a prescriber providing on-call coverage per an agreement with another prescriber or his prescriber s employer (2) a prescriber consulting with another prescriber ; or (3) orders of prescribers for hospital out-patients or inpatients. Implies that patient is not at liberty to select his on-call physician 13
Provider-Patient Relationship: TM, New Hat, Summarized Face-to-face interactive, 2-way, real-time or store-and-forward (new specificity) History (old) Updated (new-ish) Diagnosis (new) SoC as in traditional care, including, where required (new) Physical exam Diagnostic testing Doc credentialed by health plan or carrier (new) Patient gets records on request (new-ish) 54.1-3303, 2015 Session 14
Virginia BOM Authority: Overview Licensing and disciplinary authority. 54.1-2400 Health practitioners' monitoring program 54.1-2516 Podiatrists scope of practice. 54.1-2900 Receiving professional societies disciplinary action reports 54.1-2908 Defining info licensees must furnish. 54.1-2910.1 Defining PAs prescriptive authority. 54.1-2952.1 Defining qualifications to license acupuncturists 54.1-2956.9 Co-regulating NP licensure and practice 54.1-2957. 15
Guidance Document, 85-12: BOM, Telemedicine, Preamble Cf., FSMB, Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine Recognizes potential benefits Prescribing medication, medication management, monitoring Must establish the practitioner-patient relationship Must comply with SoC Some situations are appropriate for telemedicine services as a component of, or in lieu of, in-person provision of medical care, while others are not Board is committed to ensuring patient access to the convenience and benefits afforded by telemedicine services 16
85-12, Preamble, SoC: Compare to Code [P]ractitioners who provide medical care, electronically or otherwise, [should] maintain the highest degree of professionalism Cf., Va. Code 8.01-581.20: the standard of care by which the acts or omissions are to be judged shall be that degree of skill and diligence practiced by a reasonably prudent practitioner in the field of practice or specialty in this Commonwealth A physician is not an insurer of the success of his diagnosis and treatment nor is he held to the highest degree of care known to his profession. Brown v. Koulizakis, 229 Va. 524, 331 S.E.2d 440 (1985) 17
Guidance Document 85-12: Definitions [T]elemedicine services, as it pertains to the delivery of health care services, means the use of electronic technology or media, including interactive audio or video, for the purpose of diagnosing or treating a patient or consulting with other health care providers regarding a patient s diagnosis or treatment. Telemedicine services does not include an audioonly telephone, electronic mail message, facsimile transmission, or online questionnaire. Va. Code 38.2-3418.16 (as amended by HB 2063) 18
85-12: Establishing the Practitioner-Pt Relationship Where an existing practitioner-patient relationship is not present, a practitioner must take appropriate steps to establish [one] consistent with the guidelines with Virginia law, and with any other applicable law. While each circumstance is unique, such practitioner-patient relationships may be established using telemedicine services provided the standard of care is met. Test: The highest degree of professionalism or The reasonably prudent practitioner? If SoC is not met, is there then no relationship? [fn] The practitioner must adhere not only to Virginia law defining a practitioner-patient relationship, but the law in any state where a patient is receiving services... Implies doc is to know whether the pt s state defines the relationship, and if so, the substance of that law 19
85-12: Establishing the Practitioner-Pt Relationship, 2 A practitioner is discouraged from rendering medical advice and/or care using telemedicine services without (1) fully verifying and authenticating the location and, to the extent possible, confirming the identity of the requesting patient; Define: fully ; to the extent possible (2) disclosing and validating the practitioner s identity and applicable credential(s) How so validate? (3) obtaining appropriate consents from requesting patients after disclosures regarding the delivery models and treatment methods or limitations, including any special informed consents regarding telemedicine... Examples? 2015 Risks MLO of acting in a manner Board discourages? 20
Guidelines for Appropriate Use of TM Services. 85-12 The practice of medicine occurs where the patient is located at the time telemedicine services are used, and insurers may issue reimbursements based on where the practitioner is located. For consults outside Virginia, implies license needed in 2 states In Va. law, what is the legal effect of a guideline? What is the rationale for applying the law of the doctor s location for reimbursement, and that of the patient s, for everything else? Was this concession necessary? 21
85-12: Informed Consent Appropriate IC should, as a baseline, include the following: Identification of the patient, the practitioner, and the practitioner s credentials; Types of activities permitted using telemedicine services (e.g. prescription refills, appointment scheduling, patient education, etc.); Agreement by the patient that it is the role of the practitioner to determine whether or not the condition being diagnosed and/or treated is appropriate for a telemedicine encounter; Details on security measures taken with the use of telemedicine services, such as encrypting date of service, password protected screen savers, encrypting data files, or utilizing other reliable authentication techniques, as well as potential risks to privacy notwithstanding such measures; Hold harmless clause for information lost due to technical failures; and Requirement for express patient consent to forward patientidentifiable information to a third party. 22
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Informed Consent: Analysis IC is a tort concept. Virginia has relied on judgments on verdicts guided by instructions originating in 8.01-581.20 Has the Board the authority to state what the SoC for IC is? Patient agreement that practitioner determines whether the condition is appropriate for telemedicine service As opposed to whom? Details on security measures: does list suffice? Hold harmless clause: Is the Board offering legal advice? Enforceability? Part of informed consent, or a defense to claims? Forwarding: HIPAA and Va. Code 32.1-127.1:03 already govern No person to whom health records are disclosed shall redisclose [them] without first obtaining the individual's specific authorization 24
85-12: Medical Records The patient record established during the use of telemedicine services must be accessible to both the practitioner and the patient, and consistent with all established laws and regulations governing patient healthcare records. Cf., Va. Code 8.01-413: [C]opies of a patient's records shall not be furnished to such patient when the patient's treating physician in the exercise of professional judgment, has made a part of the patient's records a written statement that in his opinion the furnishing to or review by the patient of such records would be reasonably likely to endanger the life or physical safety of the patient or another person, or that such health records make reference to a person and the access requested would be reasonably likely to cause substantial harm to such referenced person. 25
85-12: Privacy, Security of PHI Maintain policies and procedures for documentation, maintenance, and transmission of the records of.tm services. Such policies and procedures should address: (1) privacy (2) health-care personnel (in addition to the practitioner addressee) who will process messages (3) hours of operation (4) types of electronic transactions permitted (5) required patient information to be included, such as patient name, identification number, type of transaction (6) archival and retrieval (7) quality oversight mechanisms Periodically evaluate for currency; maintain in an accessible and readily available manner for review Discovery? Cf. 8.01-581.16 and.17 26
Questions? Comments? Joseph P. McMenamin, MD, JD McMenamin Law Offices, PLLC 804-921-4856 27