Skip Navigation LinksConsent-to-Medical-Services-for-the-Treatment-of-Mpox-in-Minors

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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


September 20, 2022


TO:
Health Care Providers and Local Health Departments

SUBJECT:
Consent to Medical Services for the Treatment of Mpox in California Minors



Summary  

 

The California Department of Public Health (CDPH) is issuing Guidance to promote the health and safety of minors who may be exposed to or contract mpox. The guidance is based on federal and California laws and regulations, and Public Health Emergency Declarations. 

Providers should consult current FDA and CDC authorizations and recommendations, as well as applicable federal, state, and local laws. Recommendations and authorizations concerning treatment and prevention of mpox, including of minors, are subject to change without notice.  

Providers should consult their legal counsel regarding information or processes in this Guidance. Any decision to use all or part of this Guidance rests solely with the provider. This Guidance is provided as a courtesy and should not be relied upon in place of a provider’s independent professional judgment, nor should it be relied upon in place of a provider’s individual scope of practice as determined by the applicable professional practice act contained in the California Business & Professions Code. 

Background 

Mpox disease is caused by the mpox virus, related to the virus that causes smallpox. The mpox virus can spread to anyone through close skin-to-skin contact, and sexual contact has been associated with transmission in the current outbreak. Mpox symptoms are similar to but typically milder than smallpox symptoms. Mpox is rarely fatal, but severe cases may occur including bacterial superinfection, extensive skin lesions, eye involvement, and painful oropharyngeal or anorectal lesions (NEJM 2022.)    

In response to the growing mpox outbreak in the US, the State of California declared a State of Emergency on August 1, 2022, and the federal government declared a public health emergency on August 4, 2022.   

Guidance 

  1. On August 9, 2022, the U.S. Food and Drug Administration (“FDA”) issued an Emergency Use Authorization (“EUA”) for use of JYNNEOS vaccine in individuals younger than 18 for the prevention of mpox disease in individuals determined to be at high risk of mpox infection. The EUA does not require specific informed consent for persons of any age. General consent for medical care is all that is required. 

  2. The Expanded Access IND Protocol: Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children requires informed consent prior to initiating Tecovirimat treatment. Parental permission must be sought in accordance with 21 CFR 50.55 for children aged 12–17 years (permission of only one parent is required) with exceptions for adolescents, deemed as mature or emancipated minors by state and/or local law who can consent for themselves for medical care. The ultimate responsibility for decision-making regarding treatment with Tecovirimat in minors should lie with the parent or guardian, or by the adolescents, deemed as mature or emancipated minors by state and/or local law who can consent for themselves for medical care.  

  3.  A minor is defined as an individual who is under 18 years of age. 

  4.  Generally, a parent or guardian’s consent is required for the provision of healthcare, including vaccinations, to minors in California, except under limited circumstances that include: 

    • Minors ages 12-17 years who may have come into contact with an infectious, contagious, or communicable disease that is reportable to the local Health Officer, which includes outbreaks such as the current mpox outbreak, may consent to medical care related to the diagnosis or treatment of that disease pursuant to California Family Code § 6926(a).  
    • Minors may consent to all medical care if they are:    
      • at least 15 years of age; and 
      • living separate and apart from the minor’s parents or legal guardian (regardless of consent of parents/guardian or duration of separate residence); and  
      • managing the minor’s own financial affairs regardless of source of income pursuant to California Family Code § 6922.

    • Emancipated minors may consent to all medical care if they are:  
      • legally married or in an established domestic partnership; or  
      • on active duty in the U.S. armed forces; or  
      • have a court-issued Declaration of Emancipation pursuant to California Family Code §§ 7002, 7050(e)(1). 
  5. In the limited circumstances outlined above where (a) a minor can consent to medical treatment without the parent or guardian’s consent; (b) the minor in fact consents; and (c) the minor has not requested the parent or guardian be treated as a personal representative or otherwise consented to sharing the information with the parent, then health care providers and clinics, as defined in California law, must treat the medical records associated with that treatment and information about the care as confidential and must not disclose the records or information to the parent or guardian unless the minor consents to such disclosure. (42 C.F.R. § 164.502(g)(3)); California Health & Safety Code §§ 123110, 123115.) 

  6. Vaccination providers must provide the Vaccine Information Fact Sheet for Recipients and Caregivers (“Fact Sheet”) to all vaccine recipients or their caregiver. For minor patients ages 12-17 years who are consenting for their own care, providers should provide the Fact Sheet to the consenting minor, and to their parent or guardian only if the minor consents to release information to the parent or guardian. Providers shall follow their standard processes to document the minor’s consent while maintaining confidentiality. Providers may distribute the Fact Sheet or a link to the Fact Sheet.  

  7.  Providers must document that the Fact Sheet was provided.    

FAQs  

May a minor get post-exposure prophylaxis (PEP) or treatment with JYNNEOS vaccine or with TPOXX? 

Yes, a minor age 12 and older may receive medical care related to the diagnosis or treatment of mpox with or without a parent or guardian, because mpox is a communicable disease reportable under law to the Health Officer. (California Family Code § 6926(a).) 

How should a provider or clinic maintain confidentiality for a minor if they are consenting to care without their parent or guardian?  

A provider must treat the minor’s records and information about the care as confidential unless the minor consents to disclosing the records or information to the parent or guardian. The provider must utilize all the tools available to them to maintain the privacy of the minor, examples of which  might include: documenting a confidential phone number to contact the patient, refraining from using automatic text/email reminders for confidential clinic visits (including future care, such as a second vaccination), identifying clinical notes and lab results as “confidential” in the medical record so they are not released without the minor’s consent, not discussing confidential care when a parent or other person is present without first checking with the minor in private if the information can be shared. See exception below under question 4.

How does confidentiality for the provision of mpox-related healthcare for minors relate to mandated reporting laws?  

All existing mandating reporting laws still apply separate from the confidentiality rules related to sexual health care and care for minors related to mpox. Mandated reporters must make mandated reports whenever required by law.  Patients should be counseled about those limitations on confidentiality and providers should follow their institutional policies around mandated reporting. 

While clinics serving adolescents may be experienced in mandated reporting and confidentiality protection, other locations, such as mass vaccination sites, should ensure staff are fully trained and aware of mandated reporting and confidentiality requirements for minors.   

Is the JYNNEOS vaccination status of a minor recorded in the California Immunization Registry (CAIR)? Could a parent or other person with access to CAIR or other vaccination record see that a minor has been vaccinated with JYNNEOS?  

Yes, currently all JYNNEOS vaccines that are administered are reported to CDPH and available for view to those with access to CAIR, including potentially parents, guardians, or schools.   

(The CAIR Statute does permit a patient or the patient’s parent/guardian to refuse record sharing, which is referred to as “locking” the record. (Health and Safety Code section 120440(e).) Locking of a record means a record will not be shared with any parties normally permitted to receive vaccination information (e.g., schools or childcare facilities), but it does not permit “locking” all or part of a child’s vaccination record from the child’s parent or guardian.  

 

 


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