Sterilization Revised: 04-09-2015 Eligible Providers Eligible Recipients Service Requirements: Required Counseling Interpreter Services Obtaining Consent Transfer of Consent Sterilization Consent Form Exceptions to Timelines Retroactive Eligibility Covered Services Noncovered Services Billing Definitions Legal References Sterilization is any medical procedure, treatment, or operation for the purpose of rendering a person permanently incapable of reproducing. Eligible Providers Providers must be enrolled with MHCP. Ambulatory surgical centers CRNA’s Federally qualified health center Hospitals Indian health facility provider Nurse midwife Nurse practitioner Physician assistant Physicians Eligible Recipients All MHCP recipients (Medical Assistance (MA) and MinnesotaCare) except Emergency Medical Assistance (EH) must meet the following criteria: At least 21 years of age at the time the consent form is signed Mentally competent Not institutionalized Voluntarily sign the Sterilization Consent Form (MHCP will not accept a consent form signed by a guardian, conservator, or anyone other than the person to be sterilized.) Service Requirements Providers must: Obtain consent Be in possession of a completed and signed Sterilization Consent Form Required Counseling The person obtaining the consent for the sterilization must answer the recipient’s questions about the procedure, provide a copy of the Sterilization Consent Form, and explain the requirements for informed consent that are listed on the consent form. Shortly before the sterilization, the physician who will perform the procedure must explain the requirements for informed consent that are listed on the Sterilization Consent Form. Interpreter Services The provider must provide a: Language interpreter to ensure that the information about the sterilization is communicated effectively for recipients who do not understand English. Sign language interpreter to ensure that information is communicated effectively to a recipient who is hearing impaired. Obtaining Consent The Code of Federal Regulations outlines requirements, including use of the Sterilization Consent Form, for obtaining informed consent. Providers must meet all requirements for MHCP to reimburse for performing sterilization procedures. These requirements apply to all MHCP recipients (MA and MinnesotaCare). Under no circumstances will MHCP waive the requirements. It is the physician’s responsibility to obtain informed consent. If the physician does not believe the recipient can give informed consent, he or she should not perform the sterilization or may request additional information to determine whether the recipient is capable of giving informed consent (such as a psychiatric evaluation). Transfer of Consent If a recipient moves or changes providers, the consent form may be transferred to the new provider. However, the physician who performs the surgery must complete the physician section and sign within the appropriate time limits. Sterilization Consent Form The Sterilization Consent Form must be completed for MHCP to reimburse providers for performing sterilization procedures. This requirement applies to all MHCP recipients (MA and MinnesotaCare) except Emergency Medical Assistance (EH). For information about hysterectomies, refer to the Hysterectomy section; different guidelines apply. The Sterilization Consent Form and the U.S. Department of Health and Human Services Sterilization Fact Sheets are available at the following links: Consent for Sterilization Female Sterilization Fact Sheet Male Sterilization Fact Sheet If a facility or provider needs to reformat the Sterilization Consent Form, a disclaimer must be added in the upper left corner of the header that states the following: “___(insert facility or provider name)_______ certifies the text contained in this Sterilization Consent Form complies with the text in 42 CFR Part 441, Subpart F Appendix.” The facility or provider must complete a Sterilization Consent Form for each MHCP recipient who requests a sterilization procedure (see Obtaining Sterilization Consent). The Sterilization Consent Form creates an opportunity for providers to obtain informed consent by giving the recipient: An opportunity to ask questions about the sterilization process An oral explanation about the procedure and any procedural risks according to consent form requirements A copy of the consent form Advice that the decision to be sterilized will not affect future care or benefits, and the sterilization will not be performed for at least 30 days, except in the case of premature delivery or emergency abdominal surgery The recipient cannot consent to sterilization and the provider cannot accept a Sterilization Consent Form when a recipient is: In labor or childbirth Seeking to obtain or obtaining an abortion Under the influence of alcohol or other substances that affect the recipient’s state of awareness In a situation that the provider believes that the recipient is unable to give informed consent Exceptions to Timelines The following exceptions apply to the Sterilization Consent Form timelines: Emergency abdominal surgery: When the recipient to be sterilized requires emergency abdominal surgery, the sterilization may be covered at the time of emergency abdominal surgery if at least 72 hours have passed since the recipient signed the consent form. An emergency cesarean section is not considered emergency abdominal surgery. Premature delivery: When the recipient to be sterilized goes into premature delivery, the sterilization may be covered if at least 72 hours from the “From date” of admission have passed since she signed the consent form and she signed it at least 30 days before the expected date of delivery. The alternate final paragraphs section (lower right hand section of the Sterilization Consent Form) requires a choice between paragraph one or paragraph two. If you select paragraph two, provide information about the premature delivery or emergency abdominal surgery. Retroactive Eligibility Sterilization Consent Form requirements cannot be met retroactively. When a recipient without financial resources or insurance coverage requests sterilization and indicates that he or she is considering applying for or has applied for MHCP, the provider may obtain informed consent, complete a Sterilization Consent Form, and allow for the 30-day waiting period. The informed consent, completed Sterilization Consent Form and 30-day waiting period requirements must still be met. If a recipient becomes retroactively eligible for MHCP and paid for the sterilization procedure within the retroactive period, the provider must reimburse the recipient the full amount paid and may then bill MHCP if there is a valid consent form and the 30day waiting period was observed. Covered Services All sterilization procedures must follow MHCP sterilization requirements. The following sterilization services are covered: Anesthesia for intraperitoneal procedures in lower abdomen including laparoscopy; NOS Anesthesia, tubal ligation/transection Hysteroscopy, surgical with bilateral fallopian tube cannulation to induce occlusion Laparoscopy, surgical; with fulguration of oviducts (with or without transection) Laparoscopy, surgical; with occlusion of oviducts by device (for example, band, clip, or Falope ring) Ligation or transection of fallopian tube(s), abdominal or vaginal approach Occlusion of fallopian tube(s) by device (for example, band, clip, Falope ring) vaginal or suprapubic approach Vasectomy, unilateral or bilateral (separate procedure), including postop semen exam The following criteria must be met for a sterilization to be covered by MHCP: The recipient must be: At least 21 years of age at the time the consent form is signed Mentally competent Not institutionalized Voluntarily signing the Sterilization Consent Form (MHCP will not accept a consent form signed by a guardian, conservator, or anyone other than the individual to be sterilized.) Consent form signature, date and timeline requirements: Dates: Dates corresponding to signatures must be filled in by the person whose signature is on the preceding line (patient, interpreter, person obtaining consent, or physician). Consent form dates must not be typed onto the form or filled in by someone other than the signatory. Dates can be changed only to correct a clerical error. If, for example, a person writes 1/8/01 instead of 1/8/02, the error should be struck through, but not obliterated, and the correct date entered. The reason for the change should be evident. Recipient to be sterilized: The recipient to be sterilized must sign and date the consent form. At least 30 days, but not more than 180 days, must pass between the date the recipient signed the consent form and the date of surgery. Interpreter: If an interpreter was provided, he or she must sign and date the consent form after the recipient signs but before the day of surgery. Person obtaining consent: The person obtaining the consent must sign and date the consent form after the recipient signs but before the day of surgery. The person obtaining the consent certifies that, by signing the consent form, he or she orally explained the requirements for informed consent and, to the best of his or her knowledge and belief, the recipient to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized. Physician: The physician who performs the sterilization procedure must sign and date the consent form shortly before (no more than 15 days), the day of surgery, or anytime after the surgery. The physician certifies, by signing the consent form, that he or she advised the recipient to be sterilized that no federal benefits will be withdrawn if the recipient chooses not to be sterilized, explained the requirements for informed consent, and, to the best of his or her knowledge and belief, the recipient to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized. Noncovered Services MHCP does not cover: Reversal of voluntary sterilization Sterilization of a mentally incompetent recipient Sterilization of a recipient institutionalized voluntarily, civilly committed, or court ordered, in a(n): Intermediate care facilities for people with developmental disabilities or related condition (ICF/DD-RC) Regional treatment centers that are not institutions for mental disease (RTC, not IMD) RTC-IMD IMD Correctional facilities (county or non-county) Chemical dependency rehabilitation programs Residential facilities for mentally ill persons Sterilization of anyone who consented to sterilization and was under age 21 years at the time of consent Sterilization without the recipient’s informed consent, including sterilization in which a person has given consent for the recipient, including court-ordered sterilization of a mentally incompetent or institutionalized recipient Sterilizations consented to by recipients: In labor or childbirth Seeking to obtain or obtaining an abortion Under the influence of alcohol or other substances that affect the recipient’s state of awareness In a situation that the provider believes that the recipient is unable to give informed consent Billing Bill electronically Fax a copy of the Sterilization Consent Form for all sterilization claims, including physician, anesthesiologist, CRNA, and hospital or surgical center following the Electronic Claim Attachments information Use the appropriate diagnosis code For Minnesota Family Planning Program (MFPP) recipients, refer to the specific MFPP Procedure Codes covered in the MFPP section. Definitions Institutionalized Individual An individual who is involuntarily confined or detained, under a civil or criminal statute, in a correctional or rehabilitative facility, including a mental health or other facility for the care and treatment of mental illness, or confined under a voluntary commitment in a mental health or other facility for the care and treatment of mental illness. Mentally Incompetent Individual An individual who is declared mentally incompetent by a federal, state, or local court of competent jurisdiction for any purpose, unless the individual has been declared competent for purposes which include the ability to consent to sterilization. Note: A recipient who has a legal guardian or conservatorship is considered a mentally incompetent individual. Legal References Minnesota Statutes 524.5-313 Sterilization: Powers and duties of guardian 42 CFR 42 CFR 441 Appendix F Consent for sterilization 42 CFR 441.258 Consent form requirements