Telemedicine is always evolving. That's why doctors need to stay on top of the laws that dictate how they practice it.
Posted in Resources & Articles on Wednesday, March 29, 2023
Over the course of his 25-year career, John Franzen, MD, had an obstetrical/gynecological practice and later an administrative role at a large multi-specialty clinic. During this time, Dr. Franzen had no discipline issues related to his license.
Looking to transition to a less hectic position, Dr. Franzen took a job as an independent contractor/consultant with Safe Medicine, a new telemedicine provider. His duties would include prescribing medications to patients across the country.
At the time Dr. Franzen was hired, there were no specific federal regulations governing telemedicine. Nonetheless, he raised the issue of requirements with Safe Medicine.
Safe Medicine advised that patients would be required to have had a physical examination by a licensed physician within the past 24 months, and all records would be provided to Dr. Franzen for his review. Prior to dispensing any medications, Dr. Franzen would then consult with the patient by phone. However, he would not conduct physical examinations of patients nor meet with them face to face.
Safe Medicine advised Dr. Franzen that the company had four requirements for prescribing medications:
- The patient had a legitimate medical complaint.
- A comprehensive medical history had been obtained.
- A physical exam had been obtained (not necessarily by the prescribing physician) and records documented this.
- There was a logical connection between the medical complaint, medical history, physical exam and drug prescribed.
Dr. Franzen Requests Legal Evaluation
Dr. Franzen, concerned about his bounds as a licensed physician, asked that the company provide him with a legal evaluation of what he could and could not do in accordance with the standard of care.
The company shared documents detailing the standard of care for the telemedicine consulting program, as well as an analysis of the DEA’s law and policy for telemedicine practices. Safe Medicine’s legal department advised Dr. Franzen that the company’s policies and procedures were consistent with the proposed Ryan Haight Online Pharmacy Consumer Protection Act of 2008, as well as other telemedicine medical standards.
Armed with this information from Safe Medicine, but without independently reviewing his state’s medical licensing act, Dr. Franzen began prescribing medications to patients he had never met or evaluated. Some of those medications included controlled substances, such as hydrocodone, for patients with histories of persistent ailments.
He felt that Safe Medicine was just as concerned as he was about ensuring the practices were legal. Safe Medicine had a vested interest in abiding by the law and had devoted considerable legal resources to staying on top of the law’s constant changes. As such, Dr. Franzen felt he could rely upon their opinions, and he continued to practice with Safe Medicine.
Dr. Franzen Concerned; Makes Transition
At the time, what constituted a physician/patient relationship was being redefined through federal telemedicine laws and regulations. These required the prescribing physician to have a face-to-face encounter with the patient before prescribing a controlled substance.
This change, in Dr. Franzen’s view, was contrary to his practice at Safe Medicine. The company’s protocol did not allow for the type of patient encounter now required by law, forcing him to leave his position there.
Dr. Franzen took an administrative position with a company involved with corporate health plans where he would interpret and draft policies. In this position, he would no longer treat individual patients or prescribe medications.
Safe Medicine went out of business as a result of the new law.
Board Allegations Ensue
Less than two years after leaving Safe Medicine, Dr. Franzen received a notice from his state disciplinary agency asserting he had violated the state’s Medical Practice Act. At an informal conference held with the agency representative, Dr. Franzen and his counsel shared the facts of the case. Dr. Franzen provided extensive documentation from Safe Medicine regarding their research and interpretation of applicable law.
Unfortunately, the agency disagreed with Safe Medicine’s conclusions, and they recommended license suspension. Dr. Franzen did not agree with that recommendation. The matter then moved to a more serious phase of the disciplinary process.
A complaint was filed alleging that Dr. Franzen:
- Regularly authorized prescriptions for medications including controlled substances while working with Safe Medicine.
- Did not physically examine any of the persons to whom he prescribed medications.
- Had no physician/patient relationship with the persons receiving these prescriptions because they had not met with Dr. Franzen physically.
Accordingly, the complaint alleged Dr. Franzen breached the accepted medical standard of practice, citing 18 specific patient prescriptions for 18 different patients.
Dr. Franzen denied the allegations and provided additional materials and research to the disciplinary agency. Dr. Franzen and his lawyers emphasized the fact that the law was unsettled at the time of the allegations, and Dr. Franzen’s current position did not involve direct patient care or writing prescriptions.
The Board’s Decision
While sensitive and sympathetic to these factors, the agency felt discipline was necessary both for individual reasons (Dr. Franzen’s failure to independently analyze the requirements) and policy reasons, given the surge of issues related to telemedicine.
After further assessment and review, the disciplinary agency’s lawyers proposed a three-month license suspension, 25 hours of continuing education on medical ethics and a $2,000 fine. Dr. Franzen agreed to these terms. Dr. Franzen’s attorney’s fees were approximately $15,000.
What Can We Learn?
Dr. Franzen believed he had reasonably relied on Safe Medicine’s legal department’s analysis of changes in the law and prescribed medication accordingly. Unfortunately, Safe Medicine’s analysis and opinions were rejected by the disciplinary agency. In hindsight, Dr. Franzen might have conducted an independent review of Safe Medicine’s protocols and opinions as a check and balance. He could have done this by retaining his own counsel, contacting his malpractice insurance carrier or using other resources in the medical community.
That independent review may have provided support to the disciplinary agency that Dr. Franzen did not blindly rely on a for-profit entity’s evaluation to justify actions that were outside of the scope of the Medical Practice Act. Had Dr. Franzen done so before accepting the job, it likely would have helped his defense.
Though not easy, physicians who rely on telemedicine must keep current on laws, statutes and acceptable practices.
An excellent resource is the American Telemedicine Association (americantelemed.org). The National Institute of Health (nih.gov) and Centers for Medicare and Medicaid (cms.gov) also provide helpful resources.
It’s critically important to review state medical practice acts yearly for updates and changes. Regular review of these materials will help shape what is considered acceptable medical practices from a liability perspective. If a statute or law prohibits a type of telemedicine practice, a violation of that rule can be used in a lawsuit to establish that malpractice occurred. In addition, malpractice insurance policies typically exclude coverage for professional services rendered outside a physician’s license.
Consult with a state disciplinary association, an insurance carrier or broker for added insight. It can also be helpful to retain a lawyer who has expertise on malpractice litigation and disciplinary actions to navigate the often complex laws and statutes. Any expenses associated with these steps may be worthwhile if they prevent issues before they occur.
As always, thoroughly document all consultations. A case can be better defended when any potential issues are recognized, analyzed and decided upon with the best information possible.