QUEST Integration – Hysterectomy

Original Effective Date:

08/01/1994

Current Effective Date:

01/01/2015

Effective 01/01/15

Hysterectomies must be medically necessary for the treatment of disease or illness and are covered when rendered under strict Federal guidelines.

Informed Consent

Federal regulations expressly require that a patient, regardless of age or medical condition, or a representative if applicable, must be informed orally and in writing before a hysterectomy is performed that the procedure will render her permanently incapable of reproducing. A spouse, parent or close relative may act as a representative if the patient is not able to give informed consent. In an emergency, such as a ruptured uterus, a friend or even a nurse or other responsible hospital staff member may act as a representative.

Patient Acknowledgment

To ensure Federal requirements are met, the patient or a representative must acknowledge understanding in writing and receipt of this information by signing the Hysterectomy Acknowledgment Form 1145. The form may be signed by the patient or her representative before or after the procedure is performed as long as the patient was informed prior to surgery of her subsequent inability to reproduce. If the Form 1145 is signed after the procedure is done, it must contain language which clearly states that the patient was informed of the hysterectomy consequences before surgery. A copy of the signed form must be given to the patient.

Reasonable facsimiles of Form 1145 must contain all the information in the Hysterectomy Acknowledgement Form 1145, including the required signatures, dates, patient information and provisions for acknowledging subsequent inability to bear children. Forms without all these required elements do not fulfill federal requirements and are not acceptable. A hospital surgery consent form should not be used to fulfill Federal requirements as the forms have no provision for a patient’s acknowledgement of her inability to bear children.

Hysterectomies for the mentally retarded must be medically necessary. For those whose retardation is severe enough to prevent their giving informed consent, their representative must sign or countersign the form.

Time Restrictions

The form should be completed and signed in the physician’s office at the time the procedure is scheduled and discussed with the patient. Forms signed after surgery are acceptable only if the patient was orally informed before surgery of her subsequent inability to reproduce. In these cases, the form must be revised to specifically state the patient was informed of the consequences before the surgery.

There is no expiration date for a signed consent form.

Precautionary Measures

The Form 1145 should be completed whenever any abdominal or pelvic surgery is anticipated, and for private patients who are not fully covered by a medical insurance program. This will preclude claim rejections due to lack of a required form if a hysterectomy becomes medically advisable during surgery, or a private patient applies for medical assistance.

Hospital administrators should set up procedures to check for the availability of a completed Form 1145 upon the admission of a female QUEST Integration patient scheduled for lower abdominal or pelvic surgery and for private patients not fully covered by other medical insurance.

Exceptions to Consent Form Requirement

Compliance with federal and state regulations in completing the required Form 1145 is mandatory for payment of hysterectomies except in the following situations:

• The patient was already sterile prior to the hysterectomy. The physician who performed the hysterectomy must affirm the patient’s sterility in writing and state the cause of the sterility. In this context, “sterility” may be due to the post-menopausal state, a previous successful bilateral tubal sterilization procedure, or a known bilateral tubal blockage due to other disease. Not included is a simple lack of conception without demonstrated tubal blockage or other diseases or endocrine dysfunction interfering with ovulation.

Ineligible Hysterectomies

Non-compliance with Federal regulations will result in non-payment of the hysterectomy and all related services. The Federally mandated Hysterectomy Acknowledgment Form 1145, or a reasonable facsimile, must be completed as outlined above.

No payment will be made for hysterectomies performed:

• Solely for the purpose of rendering a person permanently incapable of reproducing;
• When there is more than one purpose to the procedure but sterilization was the primary intent;
• On mentally retarded persons unless medically necessary for the treatment of disease or illness. For those whose retardation is so severe that it prevents their understanding the importance of the acknowledgement form or the elements of informed consent, their representative must sign or countersign for them
• For the purpose of cancer prophylaxis in the absence of the patient having the BRCA gene.

Consent Form Requirement

• Pre-certification is not required; however, the Hysterectomy Acknowledgment Form 1145 must be signed. The form consists of patient information, provider certification that the required information was provided to the patient, and the patient acknowledgement that the required information was received. All fields on the form must be fully completed.
• Patient information
  • Patient information includes the patient’s QUEST Integration member number, full name and date of birth. Do not use nicknames. If a representative was involved, provide his/her name. If the patient does not have a QUEST Integration ID number, a statement describing the reason why there is no number may be entered, e.g., “medical assistance pending”, “private patient”, etc.
• Provider Certification
  • Complete the patient’s full name as noted above. The form is invalid if this is left blank.
  • Provide the last name and first name of the patient’s representative if the patient was not able to acknowledge receipt of the required information. The representative must sign the form. A spouse, parent, or other close relative may act as a representative and receive information on her behalf. In the event of an emergency, such as ruptured uterus, a friend or even a nurse or other responsible hospital employee may receive the information.
  • The person who warned the patient or her representative of the consequences of the procedure and her subsequent inability to reproduce, and who obtained the patient’s authorization to perform the hysterectomy must sign the form. This may be the physician, surgeon, nurse or other responsible medical staff with adequate medical knowledge to answer the patient’s questions. The date signed also is required.
• Patient Acknowledgement
  • The patient must sign the form acknowledging that before the procedure was performed she received the required information. The form should be signed prior to the surgery. However, if the patient signs the form after the surgery date, the patient must still have received the required medical information before the surgery and the language of the form must be manually changed to include statements such as “information given before surgery” and “before the operation” in the physician’s and patient’s portions of the form.
  • The representative must sign and date the form if a representative made acknowledgment of the information. The form must be signed prior to the surgery no later than the day of surgery prior to pre-operative preparations.

Claim Form Requirements

A copy of the signed consent form is not required to be attached to the claim(s) for services provided on or after 06/03/2020.

Revision History