Abstract
Purpose of Review
This article provides an overview of the legal and regulatory requirements that providers engaging in teledermatology must consider when structuring telemedicine arrangements and developing a telehealth strategy.
Recent Findings
The numerous state and federal legal and regulatory considerations applicable to teledermatology offerings are rapidly changing: new laws and regulations are proposed and adopted every year.
Summary
At the state level, requirements are often state specific and address a wide variety of topics such as establishing the physician-patient relationship, technology-specific requirements, and practice and prescribing standards when delivering care through telemedicine. At the federal level, laws and regulations address federal health care program reimbursement, digital devices, and data privacy, among other topics.
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References
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
See, e.g., Mich. Comp. Laws § 333.16171(e).
•• Interstate Medical Licensure Compact, The IMLC. https://imlcc.org/. Accessed 14 Jan. 2019. Identifies states taking part in model interstate medical licensure compact.
As of 2018, nine States – Alabama, Louisiana, Maine, Minnesota, New Mexico, Oklahoma, Ohio, Oregon, and Texas – issue special telemedicine licenses or certificates. See, e.g., Ala. Code § 34024-502; Ala. Admin. Code R. 540-X-15-.16; La. Rev Stat. § 37:1276.1; Minn. Stat. § 147.032; Ohio Rev. Code § 4731.296; Or. Rev. Stat. § 677. 139; Or. Admin. R. 847-025-0000; 22 Tex. Admin. Code § 172.12.
See, e.g., Ind. Code. § 21-1-9.5-9; see also Alaska Med Bd Policies and Procedures, “Telemedicine,” at 2.
This evaluation does not include diagnoses and treatments using controlled substances and the prescription of certain lifestyle drugs. See, e.g., Fla. Admin. Code r. 64B8-9.0141(1) (“Controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.”); N.D. Cent. Code § 19-02.1-15.1 (requiring an “in-person medical evaluation” prior to prescribing “specified drugs” including muscle relaxants, centrally acting analgesics with opioid activity, drugs containing butalbital and phosphodiesterase type 5 inhibitors when used to treat erectile dysfunction).
See, e.g., Ark. Code § 17–80-404(a)(2) (“Once a professional relationship is established, a healthcare professional may provide healthcare services through telemedicine, including interactive audio.”).
See, e.g., Iowa Admin. Code r. 653-13.11(11) (requiring provider using telemedicine to identify the patient’s medical home or treating physicians).
See, e.g., Iowa Admin Code r. 653-13.11(9).
Ariz. Rev. Stat. § 32-1401(27)(tt).
Idaho Code § 54-5703; id. § 54–5705.
Mo. Rev. Stat Ann § 191.1145.
Vt. Stat. Ann. § 9361(e).
See, e.g., Kan Stat. Ann. § 65-1626(vvv) (“A “valid prescription order” means a prescription used for a legitimate medical purpose and does not include “[a] prescription issued solely on the basis of an internet-based questionnaire or consultation without an appropriate prescriber-patient relationship.”).
See, e.g., 22 D.C. Municipal Regs. §§ 1300.7, 1399 (A valid patient-practitioner relationship means, at a minimum, that “the practitioner has met face to face with the patient, has obtained a patient history, and conducted a physical examination or evaluation adequate to establish a diagnosis.”).
See, e.g., Ala. Admin. Code r. 680-X-2-.33 (“A pharmacist shall not dispense a prescription drug if the pharmacist has knowledge, or reasonably should have known under the circumstances, that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.”)
See, e.g., Ark. Code § 17-92-1003 (requiring an in-person examination to establish a proper practitioner-patient relationship for purposes of issuing a valid prescription unless the relationship is established pursuant to Arkansas’ Telemedicine Act).
See, e.g., Minn. Stat. § 151.37 (indicating that a prescription drug order for controlled substances, muscle relaxants, centrally acting analgesics with opioid activity, drugs containing butalbital, and phosphodiesterase type 5 inhibitors when used to treat erectile dysfunction will be valid only if accompanied by an in-person examination).
•• 42 U.S.C. § 1395m. Sets forth the requirements for Medicare program reimbursement.
•• Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019, 83 Fed. Reg. 59,836 (November 23, 2018). Sets forth the requirements for “virtual check-ins” under the Medicare program.
See, e.g., Okla Admin Code § 435:10–7-13.
• Gilroy AS, Rockwell KA. Tele-ICU legal and regulatory issues. In: Koenig, MA, editor. Telemedicine in the ICU. Springer; 2019. Provides information on federal and state privacy and data security laws relevant to telehealth.
See, e.g., V.T.C.A. Occ. Code § 111.005 (requiring provision of medical records to the patient’s primary care provider within 72 hours if the patient consents).
• Bennett M, Heisey CM, Pearson IM. FDA’s evolving regulation of artificial intelligence in digital health products. 2018. https://www.jonesday.com/FDAs-Evolving-Regulation-of-Artificial-Intelligence-in-Digital-Health-Products-01-22-2018. Describes FDA’s Digital Health Innovation Action Plan.
U.S. Food and Drug Administration. Draft guidance for industry and Food and Drug Administration staff, clinical and patient decision support software. 2017. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm587819.pdf.
• South Dakota v. Wayfair, 138 S. Ct. 2080, 2099. 2018. Recent Supreme Court case that suggests that all that is required for a state to assert jurisdiction over an entity for sales tax purposes is that a business avails itself of the “substantial privilege of carrying on business” in the state.
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Taylor A. Goodspeed, Rachel E. Page, Ann T. Hollenbeck, Laura E. Koman and Alexis S. Gilroy have represented clients in the global law firm Jones Day on various legal and regulatory matters pertaining to certain topics reviewed in this article. None of these clients are aware in advance of this publication, nor did they direct any aspect of the article. The views and opinions set forth herein are the personal views or opinions of the authors and they do not necessarily reflect the views or opinions of Jones Day. The contents of this article are intended for general information purposes only and should not be considered legal advice. Telemedicine models vary significantly, and application of the legal and regulatory considerations shared in the context of illustrations used in this article could be limited. Please consider seeking the advice of legal counsel regarding specific telemedicine arrangements or questions.
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This article is part of the Topical Collection on Teledermatology
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Goodspeed, T.A., Page, R.E., Koman, L.E. et al. Legal and Regulatory Issues with Teledermatology. Curr Derm Rep 8, 46–51 (2019). https://doi.org/10.1007/s13671-019-0254-0
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DOI: https://doi.org/10.1007/s13671-019-0254-0