Mature Minor Doctrine Clarification Act: A Setback in Pediatric Immunizations

Abstract

The Mature Minor Doctrine Clarification Act, a Tennessee bill stating that a healthcare provider may not provide vaccination to a minor without the informed consent of a parent/legal guardian, poses significant challenges to pediatric immunization. We outline changes implemented to our processes in response to this bill.

A “mature minor” doctrine provides a process for minors to consent to medical procedures if, in the judgment of the treating clinician, they demonstrate they are mature enough to make a medical decision on their own behalf [1]. While there are differences in what types of procedures and care these doctrines typically cover, Tennessee was previously 1 of 5 states with a “mature minor doctrine” allowing healthcare providers to decide whether an adolescent has the capacity to consent to immunizations [2]. This was established through long-standing judicial decisions (Cardwell, v. Bechtol, 724 S.W.2d 739, Tenn. 1987) and subsequently reaffirmed by the state’s attorney general in 2003 (Tenn. Op. Att’y Gen. No. 03-087) [3, 4]. In determining who is a “mature minor,” Tennessee has followed the “Rule of Sevens,” meaning that children under 7 years of age do not have the capacity necessary to make their own decisions; children from 7 to 14 years of age are presumed not to have this capacity until proven otherwise in individual cases, and those 14 years of age and older and deemed “mature” by their treating clinician did not require parental consent for certain healthcare services, including immunizations [2, 5].

As the COVID-19 immunizations became available to minors in 2021, Dr Michelle Fiscus, medical director of Tennessee’s Vaccine Preventable Diseases and Immunization Program, shared a memo within the Tennessee Department of Health outlining the state’s “mature minor doctrine” that would allow adolescents to consent for and receive these immunizations on their own.

Anger in the state legislature around these actions ultimately led to Dr Fiscus’ firing, and Tennessee temporarily halted all state-led immunization outreach efforts for children and adolescents [6]. As this brought further attention to this doctrine, the Tennessee General Assembly acted earlier this year to pass the Mature Minor Doctrine Clarification Act in order to further limit the powers of adolescents to provide consent for immunizations. This “parental rights” bill counteracts the Mature Minor Doctrine, instead stating that a clinician may not provide immunizations to a minor without the informed consent of a parent/legal guardian. The new law also prohibits employees or agents of the state, such as the Tennessee Department of Children’s Services (DCS), from mandating that minors in state custody receive immunizations. Biological parents of children in foster care must give consent to their children to receive immunizations while in state custody. However, the DCS may also petition the court to provide for them [7].

While seemingly simple, the new law has created many pitfalls for clinicians, offices, systems, and institutions, leading to confusion, fear of liability, and additional anxiety around the process of immunizing children against deadly diseases.

These have extended beyond adolescents and the consideration of “mature minors” due to new provisions in the law around informed consent. The most critical concerns include (1) lack of clarity on what type of informed consent is required, the very definition of the term “informed,” what information should be included, and whether it must be written or can be verbal; (2) uncertainty on what and how the informed consent process must document in the medical record; (3) what limitations, if any, there may be in who can provide the information that constitutes as informed consent (nursing or physicians, eg); (4) who technically qualifies as a parent or legal guardian and is therefore authorized to provide this informed consent; (5) how to handle obtaining informed consent in situations of joint custody, stepparents, or other family members with power of attorneys. The Tennessee Chapter of the American Academy of Pediatrics and the Tennessee Medical Association have issued recommendations and FAQs to assist clinicians in navigating this new law (Table 1) [8, 9].

Table 1.

Main Points of Confusion and Possible Action

General questions
Who does the law apply to?	A minor is defined in Tennessee as an individual who has not yet reached 18 years of age. A minor who is emancipated due to marriage, military service, or court order of emancipation is no longer legally a minor. Patients turning 18 become their own legal consenters in most circumstances.
What are the key requirements for hospitals or providers under this law?	Health care providers are required to obtain an informed consent from a minor patient’s legal consenter and provide the appropriate vaccine information sheet (VIS) before each dose of certain vaccine. The VISs are written to fulfill the information requirements of the National Childhood Vaccine Injury Act, not as informed consent forms.
What should I do if the minor patient is in state custody?	The child may only be vaccinated if DCS or the state custodian consents, which can only occur if one of the following has occurred: There is an order from the appropriate court; or The legal consenter of the patient has provided or provides prior written informed consent; or A court has terminated parental rights, and all appeals are exhausted. At that point, an employee or agent of the state may request or facilitate the vaccination of a minor. Consent for vaccination is discussed with the representative of the agency that has custody, eg, the Department of Children’s Services.
Informed consent
What constitutes meeting the requirement of “informed consent?”	The vaccine information sheet (VIS) and: (1) the nature of the procedure, (2) the risks and benefits of the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient’s understanding of elements 1 through 4. In addition, any patient-specific health information, such as the patient’s individual risk of receiving a particular vaccine, as well as the possible outcomes of not receiving it should be included.
Who can consent on the patient’s vaccination?	A parent or legal guardian. For children whom custody is shared 50–50 among both parents, only 1 is required to consent.
What do I need to document in the EHR?	The informed consent form for the administered vaccine signed and dated by the patient’s legal consenter should be included in the EHR. The informed consent discussion, including any patient-specific risks, benefits, and alternatives, should be noted in the chart.
Does informed consent needs to be written?	The new state vaccine law does not require informed consent to be in writing, and informed consent could be obtained over the phone and documented in the EHR. However, the Tennessee Medical Association has strongly recommended to do so.
Other
What risks might be posed for health care providers or hospitals who do not follow the requirements for an informed consent through this new Tennessee law?	Licensure board penalties, civil liability, and medical malpractice are potential risks.

St. Jude Children’s Research Hospital (St. Jude) in Memphis, TN, specializes in catastrophic diseases such as cancer, sickle cell disease, and HIV. Many of our patients are at risk of severe disease from vaccine-preventable illnesses. Several roadblocks were encountered in preparation of our annual influenza immunization campaign that have required revised processes. An institutional lawyer was added to the planning group to assist with processes and ensure compliance. First, an informed consent form was created that would capture all doses of all immunizations, as parents likely need to provide separate consent for each immunization at every point of administration. The most conservative approach was advised, which included obtaining signed consent for each dose of each vaccine at every visit. Given the number of vaccines and doses, it is challenging to create a document that is comprehensive yet simple, easy to use and administer (whether on paper or electronically) and that does not significantly disrupt clinic flow processes. The Vaccine Information Statement (VIS) for each immunization has always been provided and discussed with caregivers, however, including the date of the most recent VIS sheet in the consent form has been a barrier to streamlining implementation of this process. As the consent form is part of the medical record, no additional documentation is made in the chart other than which immunizations were administered, any patient-specific information or risks, and any questions raised by patients or caregivers. St. Jude has decided that any healthcare professional caring for the patient can obtain informed consent and has not limited this process to physicians. While the law does not specify that written consent is needed, and phone consent may be possible per some interpretations, St. Jude has opted to obtain written consent unless an opportunity for immunization would be missed, in which phone consent may be obtained.

The issue of who can provide consent for a minor to receive immunizations has been 1 of the points of confusion of this law, as the terms parent and legal guardian are defined differently in different areas of the Tennessee code. Parents are not clearly defined by the law or code, and often a biological parent is not available or may not be a legal consenter for a child. According to the Tennessee Medical Association, until the Department of Health provides further clarification, healthcare providers should operate under the most conservative definition of “parent” which is biological father or mother of the minor patient [8]. St. Jude decided to permit individuals with legal consent authority to sign informed consent forms for immunizations, regardless of their relationship to the patient. Deploying the new process has generated confusion. Lawyers were consulted many times on whether a specific situation would allow immunization, despite clear medical indications. As more patients were vaccinated, more frequently asked questions were raised, and a document was developed for frontline professionals to address common problems and ensure a smoother process.

UT Le Bonheur General Pediatrics (ULPS), an academic teaching practice within a large healthcare system, provides general pediatrics care for a panel of around 6000 patients in the heart of Memphis, approximately 95% of whom are insured through the state Medicaid program. Patients are often accompanied by grandparents, siblings, aunts or uncles, or other noncustodial caregivers, many who may in fact be the primary caregiver for the patient, which has presented challenges for proper consent. The ULPS system has also implemented new processes, provided extensive education, and consulted with institutional lawyers. ULPS has taken the approach of allowing for verbal informed consent, also utilizing VIS sheets, and providing a preformed block of text that can be inserted using keyboard shortcuts for simple documentation in the medical record that information was provided, and that consent was obtained from a parent or legal guardian. However, parents or legal guardians are often not present and not available in clinic and sometimes have not been present in the child’s life for many years. The law has led to children not being able to receive routine immunizations during their medical visit and in some cases has prevented them from attending school due to the lack of required immunizations, not to mention the lack of protection against potentially deadly diseases. This is important as the number of fully immunized children entering kindergarten in TN has trended down for 3 consecutive years, with some vaccines being below the 95% established goal by the state and only 27% of counties reporting at least 95% of kindergartners enrolling in school as being fully immunized. The impact of this new legislation cannot be entirely estimated at this point although this data demonstrates the decrease in immunization rates even before the implementation of this law, likely due to many reasons around access to healthcare, the impact of the COVID-19 pandemic, and vaccine mis- and disinformation that abounds. The complexity of the current situation only adds to the known increase of religious exemptions and temporary certificates [10]. The law places additional constraints around children in state custody, clearly requiring written consent from the parent or legal guardian (although still not clarifying those terms) or requiring a judge’s order. The clinic has seen many children in this situation that they have been unable to immunize due to a lack of signed consent from a biological parent at the time of the visit. As influenza season approaches and our clinics attempt to provide these immunizations, uncertainty regarding this law has been a barrier, as these vaccines are administered throughout the system. Similar concerns have arisen at back-to-school immunization events and other efforts intended to prepare children for school, catch up on immunizations, and maximize their health.

While systems continue to navigate these changes, several options exist to improve the current law in order to facilitate and expand access to immunizations so that children can remain protected against vaccine-preventable illnesses and ensure on-time school entry. Additional legislation or rules may be brought that can provide clarity on some of the challenges embedded in the current law, including clarification on who can provide consent, the definition of a parent or legal guardian, the type of consent required, and the frequency in which this consent is needed. For instance, can a parent provide a written notice that the caregiver accompanying the child has the power to consent for immunizations? Can this be done through an electronic portal? What period would such a notice cover—1 visit or an entire year? The law has a provision that allows the Tennessee Department of Health to promulgate rules to effectuate the act, which could include providing guidance around issues such as these. While the department has not yet provided any public action, details around these issues and others could potentially be clarified through this process with the input from professional medical groups. Additional legislation may be required to clarify portions of the Tennessee code and to amend the language around children in DCS custody, where the requirements and provisions are more clear and severely restrictive. Professional medical organizations continue to lobby legislators and the Department of Health around these issues and have asked parents and caregivers to contact their legislators as well. These issues have been highlighted in the media which has helped bring attention to the issue and increase activism around it as well [11]. Offices and medical systems may consider using standardized scripts and language to inform parents and caregivers of the new law so that they can be prepared and potentially make the needed provisions to ensure that the vaccination process goes smoothly for their child. Partnerships and coalitions across the state may be considered to provide best practice recommendations to clinicians and to lawmakers as both navigate these issues.

At a time when vaccine hesitancy and refusal are increasing, leading to record low rates of immunizations, any process that interferes with, complicates, and limits access to immunizations is a setback in efforts to keep children healthy [12, 13]. While extraordinary efforts have been undertaken to navigate these laws in order to immunize children while also remaining in compliance with the law, it has caused many children to remain under-immunized. It is critical that artificial barriers to immunizations not interfere with lifesaving medical care and one of the greatest public health benefits of our time—child wellness immunizations. The Tennessee General Assembly and Department of Health should work through new legislation and their rule-making process to address this potential public health crisis in order to improve access to immunizations in Tennessee which will ultimately lead to increased immunization rates.

Notes

Financial support : This work was supported in part by the American Lebanese Syrian-Associated Charities ALSAC. No additional external funding was received for the study.

Potential conflicts of interest. Both authors: No potential conflicts of interest.

Author contribution

Drs Yaun and Hijano drafted the initial manuscript and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of this work.