Human Sterilization and Informed Consent
Provider Type
- Physicians
- Participating Physician Groups (PPG)
- Hospitals
- Ancillary
Providers must inform Medi-Cal members before they undergo sterilization procedures and providers must obtain the member's consent.
Sterilization performed because pregnancy would be life-threatening to the mother (therapeutic sterilization) is included in this requirement; however, sterilization that is the unavoidable secondary result of a medical procedure, and the procedure is not being done in order to achieve it, is not. Procedures that would ordinarily require consent are excluded if the member is already sterile.
Required Information
Providers must provide members to be sterilized with the Department of Health Care Services (DHCS)-published brochure on sterilization before obtaining consent. The following are the only sterilization information booklets approved by DHCS:
- Permanent Birth Control for Women
- Metodo Anticonceptivo Permanente Femenino
- Permanent Birth Control for Men
- Metodo Anticonceptivo Permanente Masculino
Providers can log in to the DHCS website to download and print the booklets.
A physician or designee who obtains consent for the sterilization procedure must offer to answer any questions the member may have regarding the procedure. In addition, all of the following must be discussed with the member seeking to be sterilized:
- A full description of available alternative methods of family planning and birth control
- A description of benefits or advantages that may be expected as a result of the sterilization
- A thorough explanation of the specific sterilization procedure to be performed, including information on whether the procedure is established or new
- The name of provider performing the procedure. If another provider is substituted, the member must be notified prior to anesthesia of the new provider's name and the reason for the change
- Advice that the sterilization procedure is considered irreversible
- A full description of the discomforts and risks that may accompany or follow the procedure, including an explanation of the type and possible side effects of any anesthesia
- Approximate length of hospital stay, recovery time and any cost to the member
- Advice that the sterilization will not be performed for at least 30 days (except in the case of emergency abdominal surgery or premature birth, and then only when specific criteria is fully met)
- Advice that the member is free to withhold or withdraw consent at any time before the procedure without affecting the right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the member might be entitled
The provider must fully and correctly complete the Consent Form PM 330 after discussing the above topics with the member. Refer to the Certification of Informed Consent for Reproductive Sterilization discussion below for about completing the Consent Form PM 330.
Certification of Informed Consent for Reproductive Sterilization
The Department of Health Care Services (DHCS) Consent Form PM 330 (English PDF, Spanish PDF) is the only form approved by DHCS for certification of informed consent. Before obtaining consent and completing the PM 330 for any sterilization procedure, a provider or providers' designee must discuss and furnish the following information to the member seeking sterilization:
- A full description of available alternative methods of family planning and birth control.
- A description of benefits or advantages that may be expected as a result of the sterilization.
- A thorough explanation of the specific sterilization procedure to be performed, including information on whether the procedure is established or new.
- The name of the provider performing the procedure. If another provider is substituted, the member must be notified of the new provider's name and the reason for the change prior to anesthesia.
- Advice that the sterilization procedure is considered irreversible.
- A full description of the discomforts and risks that may accompany or follow the procedure, including an explanation of the type and possible side effects of any anesthesia.
- Approximate length of the hospital stay, recovery time and any cost to the member.
- Advice that the sterilization will not be performed for at least 30 days (except in the case of emergency abdominal surgery or premature birth, and then only when specific criteria is met).
- Advice that the member is free to withhold or withdraw consent at any time before the procedure without affecting the right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the member might be entitled.
The provider must fully and correctly complete the PM 330 after discussing the above topics with the member. The form must include the name of the provider or clinic furnishing the procedure information and the provider or clinic performing the procedure (lines 1 and 5 on the PM 330). These lines on the form may be pre-stamped or typed. The name of the procedure must be included on lines 2, 6, 13, and 20 and must be consistent throughout the form and match the name of the procedure on the claim submission. These lines may also be pre-stamped or typed. Providers must cross out the alternative final paragraph on the form that is not used. If the minimum waiting period of 30 days has been met, providers must cross out paragraph 2. If the minimum waiting period has not been met, providers must cross out paragraph 1.
The PM 330 must be signed and dated by the member to be sterilized, the interpreter (if one is used in the consent process), the person who secured the consent (for example, physician or intake nurse), and the provider performing the sterilization. Providers must attach a fully completed informed consent form to all sterilization procedure claims. Claims for sterilization procedures are not paid unless the informed consent form is attached.
Providers must note in the member's medical record that the provider gave the member the DHCS-published brochure about sterilization and a copy of the consent form. Providers must retain a copy of the signed consent form in the member's medical record.
Conditions Under Which Sterilization May Be Performed
Sterilization may be performed only if:
- The member is at least age 21 at the time consent is obtained.
- The member is not mentally incompetent.
- The member is able to understand informed consent.
- The member is not institutionalized.
- The member has voluntarily given informed consent in accordance with all prescribed requirements.
- At least 30 days, but not more than 180 days, have passed between the date of informed consent and the date of the sterilization.
Refer to the Exceptions to Time Limitations discussion below for information regarding the time requirement in the case of emergency abdominal surgery or premature delivery.
Conditions Under Which Informed Consent May Not Be Obtained
Informed consent may not be obtained while the member to be sterilized is:
- In labor or within 24 hours postpartum or post-abortion.
- Seeking to obtain or obtaining an abortion.
- Under the influence of alcohol or other substances that affect the member's awareness.
Exceptions to Time Limitations
Sterilization may be performed at the time of emergency abdominal surgery or premature delivery if at least 72 hours have passed after the member gave written informed consent to be sterilized and the written informed consent to be sterilized was given at least 30 days before the member originally intended to be sterilized, or the written informed consent was given at least 30 days before the expected date of delivery.
Informed Consent Process Requirements, Documentation and Noncompliance
The following criteria must be met for compliance with the informed consent process for Health Net members:
- The informed consent process must be conducted either by a physician or the physician's designee
- Suitable arrangements are made to ensure that the information is effectively communicated to a member who is deaf, blind or otherwise disabled
- An interpreter is provided if the member to be sterilized does not understand the language used on the consent form or the language used by the person obtaining the consent
- The member to be sterilized is permitted to choose a witness who is present when consent is obtained
- The sterilization operation is requested without fraud, duress or undue influence
Medical Record Documentation
There must be documentation in the progress notes of the member's medical record that a discussion regarding sterilization has taken place, including the answers given to specific questions or concerns expressed by the member.
The original signed consent form must be filed in the medical record. A copy of the signed consent form must be given to the member, and a copy placed into the member's hospital medical record at the place where the service is performed (for example, hospital or outpatient surgery center). Providers must also note the fact that the Department of Health Care Services (DHCS)-published brochure on sterilization and a copy of the consent form were given to the member.
If the procedure is a hysterectomy, a copy of the Hysterectomy Informed Consent (PDF) form must be placed in the medical record. The form is obtained from the hospital performing the procedure.
Office Documentation
All participating providers are responsible for maintaining a log of all sterilization procedures performed. This sterilization procedures log (PDF) must indicate the member's name, the date of the sterilization, the member's medical record number, and the type of procedure performed.
Non-Compliance
The Health Net Public Programs Quality Improvement (PPQI) Department monitors participating providers for compliance with the consent process for sterilization. Deficiencies are to be remedied through corrective action and follow-up auditing. DHCS also performs audits for compliance. Health Net, its affiliated plans, and DHCS are required to refer non-compliant providers to the California Board of Medical Quality Assurance.
Special Considerations for Hysterectomy
A hysterectomy may not be performed solely for the purpose of rendering an individual permanently sterile. If a hysterectomy is performed, a Hysterectomy Informed Consent (PDF) form must be completed in addition to the other required forms.