In August 2019, a New Hampshire physician sent a letter to the New Hampshire Board of Medicine with a straightforward inquiry: “Is direct to patient, asynchronous teledermatology medically acceptable here in New Hampshire?” It’s a fair question and one, in varying forms, that is being asked across the country by the myriad companies and licensed physicians, pharmacies, and pharmacists providing telehealth care. With each state planting and replanting their own subjective regulatory flags, national telehealth providers are scrambling to understand when, where, and how telemedicine* can be delivered in each state.
With each state planting and replanting their own subjective regulatory flags, national telehealth providers are scrambling to understand when, where, and how telemedicine can be delivered in each state.
As telemedicine regulation evolves, the practice of telemedicine continues and, with it, disciplinary matters are cropping up around the country. So what are the reasons physicians are being disciplined for engaging in telemedicine? It’s a difficult question to answer because these matters are relatively rare, leaving little precedent and gaping unknowns as to the practical application of telemedicine regulations. The vast majority of medical board disciplinary cases are a product of traditional in-person care, criminal convictions, and substance abuse issues--meaning that it is uncommon to find a disciplinary matter that is related to telemedicine. A review of all publicly available online disciplinary proceedings in front of state medical boards from June 2019 to December 2019 revealed that less than 1% of these disciplinary matters involved the use of store-and-forward technology. With that said, telemedicine discipline is occurring in some states as medical boards take action. The disciplinary proceedings discussed below provide insight into how regulators are addressing telemedicine practice issues and specifically the use of store-and-forward/asynchronous technologies.
This article features three recent 2019 decisions in California, Texas, and Iowa where physicians were disciplined for telemedicine violations. For each of the following case studies (which are based on publicly available information), it appears that the physician relied solely on store-and-forward technology prior to writing the prescriptions. Unfortunately, the facts that led to the disciplinary complaints are somewhat vague leaving us to draw conclusions based on the alleged violations. As to the good doctor’s question, the New Hampshire Board of Medicine during a September 2019 Board meeting did not provide any substantive guidance and instead referred the physician to a recently passed 2019 statute; in essence, the Board was unwilling to issue an advisory opinion. The lack of precedential facts in these cases and boards’ unwillingness to provide advisory guidance continues to leave telemedicine providers in foggy regulatory waters with no lighthouse in sight.
FACTS: In 2014 and early 2015, a Medical Board of California investigator logged into the telehealth website www.kwikmed.com under fictitious names and answered a series of asynchronous online questions regarding medical data and history for two fake patients seeking prescriptions, respectively, for contraceptives and erectile dysfunction medications. Based solely on the store-and-forward questionnaire, Dr. Richard Holmes wrote prescriptions for the contraceptive ella® and the erectile dysfunction medication Viagra®. In 2017, the State of California brought a disciplinary action against Dr. Holmes’ physician license alleging gross negligence, repeated negligence, incompetence, and furnishing dangerous drugs without an examination. Based on the State of California’s complaint, Dr. Holmes appears to have had no synchronous (video or audio) interaction with the patient prior to writing the prescriptions.
LAW: The crux of all causes of action brought by the State against Dr. Holmes was a failure to meet the standard of care. For both prescriptions, California argued that Dr. Holmes failed to conduct a physical examination, which--according to the Complaint--was required prior to the prescription of these medications. In support of the accusations, California cited Section 2242 of the Code of Regulations, which states: “(a) No person or entity may prescribe, dispense, or furnish, or cause to be prescribed, dispensed, or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state, without an appropriate prior examination and medical indication, except as authorized by Section 2242.” In both cases, California argued that additional requirements were necessary to meet the standard of care including a pregnancy test for the Ella prescription and performing a genital examination for the Viagra prescription.
DISCIPLINE: Dr. Holmes ultimately surrendered his California license voluntarily pursuant to a Stipulated Surrender of License and Order dated February 8, 2019, and was fined $30,000. Subsequent to his license surrender, the California Board of Pharmacy concluded a separate disciplinary matter brought in January 2018 against the Kwikmed pharmacy, which presumably** filled prescriptions obtained on the website www.kwikmed.com, alleging the pharmacy had filled over 14,000 prescriptions that were “obtained over the internet, not issued pursuant to good faith prior examination, and were pursuant to prescriptions written by physicians not licensed in California to treat California patients.” Kwikmed pharmacy agreed to a Settlement on February 5, 2019 that included a $275,000 fine. Within a week of these related matters being resolved, a bill was introduced in the California legislature seeking to amend Section 2242 to clarify that synchronous interaction is not required to prescribe medication provided that the appropriate standard of care is met (Section 2242(a) reads, in part, "... An appropriate prior examination does not require a synchronous interaction between the patient and the licensee and can be achieved through the use of telehealth, including, but not limited to, a self-screening tool or a questionnaire, provided that the licensee complies with the appropriate standard of care.” Cal. Bus. and Prof. Code § 2242). The bill would eventually pass and become effective immediately in October 2019. NABP Solutions was unable to find any public record or statement by the bill’s author that would suggest the legislation was prompted by the outcomes of these two disciplinary matters. The bill author’s stated in a press release she was seeking to expand access to telemedicine:
“‘Birth control allows people to choose if and when to start a family and historically has afforded women more economic freedom,’ said [California] Assemblywoman [Cottie] Petrie-Norris (D-Laguna Beach) ‘It is paramount that women have access to the resources necessary to carefully plan a family as they see fit.’”
Regardless of the motivation for the bill’s filing, it is safe to conclude the newly revised regulation would have impacted Dr. Holmes’ and Kwikmed’s matters.
FACTS: On July 30, 2018, Dr. Aruna L. Yarrozu prescribed lidocaine cream to a patient via telemedicine. According to the Texas Medical Board Agreed Order, Dr. Yarrozu did not utilize synchronous audio or video to evaluate the patient. The Agreed Order also states that Dr. Yarrozu failed to contact the patient to discuss the risks and benefits of the topical medication prior to prescribing the drug. The presumption here is that Dr. Yarrozu’s patient engagement was limited to asynchronous store-and-forward, but this is not explicitly stated in the publicly available information online. We attempted to secure more information from the Texas Medical Board on this matter, but in a response to our public records request the Board stated in a December 12, 2019 email, “Complaint information and material related to an investigation of a license holder is confidential, pursuant to section 164.007(c) of the Medical Practice Act and Previous Determination Letter Ruling OR2007-03117, dated March 22, 2007, issued by the Office of the Attorney General.”
LAW: The Texas Medical Board alleged in its Complaint that Dr. Yarrozu did not meet the proper standard of care for prescribing the medication in addition to other claims alleging negligence, failure to use proper diligence in professional practice, failure to safeguard against potential complications, and failure to obtain informed consent from the patient. The Board cited, in part, Rule 174.6(a), which states that telemedicine practice is held to the same standards applied to an in-person setting and requires that a practitioner-patient relationship is established while accurate medical records are kept. According to the Agreed Order, the Board “found Dr. Yarrozu prescribed lidocaine cream to a patient without performing an appropriate telemedicine evaluation prior to prescribing and without explaining the risks and benefits. Dr. Yarrozu did not have a contemporaneous video evaluation and/or an audio connection with the patient.” Based on this finding, the presumption here is that Dr. Yarrozu only relied on an asynchronous interaction with the patient.
DISCIPLINE: On October 18, 2019, the Board and Aruna L. Yarrozu, M.D., entered into an Agreed Order requiring her to complete at least eight hours of Continuing Medical Education and, within 60 days, to pay an administrative penalty of $1,000. Considering the history of telemedicine regulation in Texas, any telemedicine-related discipline that arrives in the wake of the Teledoc, Inc. v. Texas Medical Board matter is noteworthy.
FACTS: On December 20, 2019, the Iowa Board of Medicine entered into a Statement of Charges and Settlement Agreement with Dr. Scott T. Roethle, an Iowa-licensed physician who practices medicine in Overland Park, Kansas, and via telemedicine in multiple states. The Board alleged that Dr. Roethle “failed to conform to the minimal standard of acceptable and prevailing practice of medicine when he prescribed medications to a patient via telemedicine using electronic means, without establishing an appropriate physician-patient relationship sufficient to establish an informed diagnosis and provide appropriate medical care”. The Board alleges that [Dr. Roethle] failed to perform an adequate interview of the patient to collect the relevant medical history and/or perform a physical examination sufficient for the diagnosis and treatment of the patient in Iowa.” The publicly available filings on the matter do not state the company, website, or mobile application that Dr. Roethle was working for, or utilizing, when the violations occurred. Research online indicates Dr. Roethle is, or has been, a provider, advisor, or cofounder, in a handful of telemedicine practices including www.modrnhealth.com, www.myDrScott.com (offline), and www.careparrot.com/ (offline).
LAW: Dr. Roethle was charged, pursuant to Iowa Administrative Code sections 147.55(2), 148.6(2)(g) and 272C.10(2), and 653 IAC 23.1(2)(f) and 13.11(7), (8), (9), and (21), with failing to conform to the minimal standard of acceptable and prevailing practice of medicine. Section 13 of the Iowa Administrative Code specifically permits telemedicine care (as long as the “standard of care does not require an in-person encounter”), but also states under Section 13.11(8), the use of “[a]n Internet questionnaire that is a static set of questions provided to the patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview, does not constitute an acceptable medical interview and physical examination for the provision of treatment, including issuance of prescriptions, electronically or otherwise, by a licensee.” In addition, Section 13.11(21) states, “Prescribing to a patient based solely on an Internet request or Internet questionnaire (i.e., a static questionnaire provided to a patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview) is prohibited. Absent a valid physician-patient relationship, a licensee’s prescribing to a patient based solely on a telephonic evaluation is prohibited, with the exception of the circumstances described in subrule 13.11(20).” Considering both of these Sections were explicitly referenced in the Complaint, the presumption is that Dr. Roethle only utilized store-and-forward technology prior to writing the prescriptions.
DISCIPLINE: Under the terms of the Settlement Agreement, the Board issued Dr. Roethle a Citation and Warning and ordered him to pay a $5,000 civil penalty for violating the laws and rules governing the practice of medicine in Iowa.***
The unfortunate reality of many board actions, including the ones presented herein, is the lack of clearly presented, publicly available details that led to the disciplinary outcome. Without detailed facts, stakeholders do not have concrete takeaways or precedent that can serve as guidance. Even so, we can draw some conclusions from these case studies: asynchronous/store-and-forward technology used independently of any other modality is potentially problematic for some boards. Due to the scarcity of available information on these fact sensitive matters (which are often resolved by settlement before a hearing), we are left to speculate on the actual expectations of medical boards in this burgeoning field of care delivery.
These complaints suggest a predisposition against the use of asynchronous technology (although some of the bias is explicitly spelled out in certain state regulations, which prohibit the use of asynchronous-only telemedicine). With regard to the Iowa and Texas matters, it is difficult to determine what other facts were considered including the effectiveness of the modality used to gather the necessary information to make an informed clinical decision: We do not know the depth and intricacy of the questions being asked; we do not know the logic of the technology as it branches into a series of follow-up questions based on the patient information provided; and we do not know the overall comprehensiveness of the patient engagement. With the California case where the facts are more clearly defined, the matter settled without the medical board weighing in on the evidence. Consequently, the only clear takeaway from these matters is that store-and-forward, when used independent of other modalities, has the potential to increase regulatory scrutiny.
As an alternative, stakeholders argue that the standard of care analysis should be applied in all patient engagements regardless of the modality. This, in fact, is the case in some states, including Maryland, which recently revised its rules to state:
“The Board shall use the same standards in evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee's practice.” Maryland Sec. 10.32.05.07, Telehealth Practitioner Discipline
The modality used--and its potential limitations--may be a factor in meeting the standard of care, but should it be the singular defining reason that the standard was not met? It is too soon to suggest that asynchronous-only prescribing is the primary red flag that a state medical board will look for in these types of matters, but anecdotally in 2019 this seems to be the case. These recent disciplinary matters and the ever-changing regulatory shifts in telemedicine suggest that the struggle between the proper modalities and standard of care will continue to unfold for the foreseeable future.
Marty Allain is the Executive Director of NABP Solutions, an NABP subsidiary consulting firm, and an attorney with over 15 years of experience in pharmacy and wholesale drug distribution regulatory compliance. He is the former Executive Director of the Indiana Board of Pharmacy and former General Counsel of the Indiana Professional Licensing Agency where he helped oversee legislative activity and rule promulgation for the Medical Licensing Board of Indiana, among several other healthcare boards. He most recently served as Senior Manager of NABP's Digital Health services, administering NABP's pharmacy and telemedicine website verification, which is required by search engines (Google, Bing, and Yahoo) and social media (Twitter and Snapchat) for advertising prescription drug products; NABP's pharmacy merchant certification, which is required by card networks (Visa and Mastercard); NABP's domain name registry operation (for the top level domain .pharmacy); and NABP's rogue website identification program.
*We use the term telehealth and telemedicine interchangeably throughout the article as each individual state may use one or both to describe provider-to-patient care delivered through virtual modalities. Note the American Telemedicine Association’s explanation of the terms here: “While there’s no common definition of telehealth (and its many synonyms), the term itself can evoke a limited view of what telehealth does. What was, until recently, referred to as telemedicine now encompasses a much broader array of services and technologies...”
**The Complaint against PCM Venture LLC dba Kwikmed does not explicitly state the prescriptions came from the www.kwikmed.com website; however, the aforementioned website does state the medication prescribed on the site is dispensed from “our pharmacy” and that there is a cost associated with transferring the prescription to a different pharmacy, “Costs associated with having a Physician review your medical history, having our pharmacy fulfill your prescription, and all associated processing costs are built into the cost of the medication. We do everything possible to keep these costs to a minimum and pass the savings on to you. If you request the prescription to be filled at a different pharmacy there is a $120.00 processing fee.” See https://www.kwikmed.com/frequently-asked-questions/#24
***Dr. Roethle also settled a similar disciplinary matter with Texas Medical Board in December 2019 when, “[Dr. Roethle] failed to adhere to the standards for the provision of Telemedicine Medical Services because he failed to communicate with patients via audio or video in real time when treating them.” The Texas Medical Board ordered Dr. Roethle to take the Medical Jurisprudence Exam and 8 hours of continuing education within one year of the Settlement Order’s entry to maintain his license in the state.