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FDA Finalizes Guidance on Informed Consent for Clinical Investigations

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”).

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California Department of Managed Health Care Wades Into Debate Regarding Unlicensed Practice of Medicine

Time to Read: 3 minutes Practices: Health Care

Facing increased pressure to curb health care costs on the one hand, and heightened concerns over health information privacy and patient safety on the other, health care companies must regularly make difficult decisions regarding when and how to delegate responsibility to unlicensed employees. Laws forbid unlicensed individuals from the practice of medicine, including any kind of medical decision-making. But a report published last week by the California Department of Managed Health Care (DMHC) suggests health care companies may delegate certain tasks to unlicensed individuals, so long as policies and procedures “reduce the likelihood” that an unlicensed individual will exercise medical discretion. In issuing its cautious stamp of approval, DMHC reasoned that “it may not be possible to completely eliminate all exercise of judgment in this or any process, even if an automated and interactive voice messaging system were used. . . . Properly executed, this type of customer service is crucial to ensuring access to health care for millions of Californians.”

DMHC’s Investigation

DMHC’s report evaluated a 24-hour “appointment and advice” telephone line for members of Kaiser Foundation Health Plan, a prepaid health maintenance organization. Calls are received by unlicensed teleservice representatives (TSRs), who respond to health plan members using computerized scripts written by licensed professionals.

DMHC concluded that the health plan’s system was structured to ensure that TSRs do not provide medical advice or evaluation. Furthermore, while acknowledging that it may be impossible to prevent TSRs from exercising some level of discretion, DHMC found no evidence that TSRs deviate from the system to provide medical evaluation or advice. Nevertheless, DMHC plans to continue to monitor the situation for six months.

Key Features of the Call Centers

DMHC identified the following features of the call centers as especially important to its conclusions: 

  • Licensure: The call centers are licensed and certified by the California Department of Consumer Affairs. 
  • Access to Licensed Professionals: Physicians are available at all times to the call centers, and registered nurses are staffed at each call center. If a question arises regarding a caller’s medical condition, scripts prompt TSRs to forward the caller to a registered nurse. 
  • Steps to Reduce Patient Confusion: The health plan refers to its centers as “appointment and advice call centers” rather than “nurse advice lines” and requires TSRs to identify themselves as an unlicensed staff person to each caller. 
  • Adherence to Scripts Written by Medical Professionals: TSRs respond to calls using scripts written in advance by a team of physicians and nurses. The health plan requires TSRs to read scripts as written, without deviation, at all times. 
  • Periodic Updating of Scripts: A team of physicians and registered nurses meet monthly to update the scripts. Scripts are updated at minimum once every two years. 
  • Regular Audits of Calls: Management and quality improvement teams regularly audit calls to detect deviations from scripts; “automatic failures” (such as the provision of inappropriate clinical advice, failure to identify oneself as an unlicensed staff person, or failure to recognize emergent symptoms); and whether the TSR selected the best script and outcome for the caller’s situation. In addition to regular monitoring, management monitors five calls per week for each new TSR during the first 90 days of employment. 
  • Special Procedures for Emergent Conditions: Whenever a caller presents information of a medical nature, such as information describing medical symptoms, the first script requires TSRs to screen through a list of emergent clinical symptoms. TSRs are trained to immediately refer callers with emergent symptoms to a registered nurse. 
  • No Production Requirements: The health plan does not require its TSRs to respond to a certain number of calls, schedule a certain number of appointments, or meet any other numerical quota.

Relevance and Next Steps

DMHC’s report does not carry the force of law, but it does provide one more data point to define the unlicensed practice of medicine in the context of the health care industry’s increased reliance on computer and telephone technologies. DMHC has implied that it is permissible for health care companies to employ unlicensed individuals to perform basic tasks, even if this may cause an unlicensed individual to exercise a limited level of discretion. The report suggests that with proper planning and appropriate use of technology, tasks that do not require the hands-on involvement of licensed professionals can be delegated to unlicensed personnel – keeping open the door to innovation, better service and better use of licensed professionals.

If you have questions or would like further information, please contact any of the attorneys listed on this page.

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