(A) Sterilization procedures will be reimbursed only if the following requirements are met:

(1) The sterilization must be the result of a voluntary request for such services by a recipient legally capable of consenting to such a procedure.

(2) The individual is at least twenty-one years old at the time consent is obtained.

(3) The individual is not mentally incompetent. For program purposes, "mentally incompetent individual" is defined as a person who has been 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.

(4) The individual is not institutionalized. For program purposes, "institutionalized individual" is defined as an individual who is:

(a) Involuntarily confined or detained, under a civil or criminal statute, in a correctional or rehabilitative facility, including a mental hospital or other facility for the care and treatment of mental illness; or

(b) Confined, under a voluntary commitment, in a mental hospital or other facility for the care and treatment of mental illness.

(5) The individual has been given a thorough explanation of all elements of the department's approved consent to sterilization form prior to giving consent for the procedure to be performed. In addition, the recipient must have been made fully aware that he/she is free to withhold consent to the procedure at any time before the sterilization, without affecting the right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the individual might be otherwise entitled. In instances where the individual is blind, deaf, or otherwise handicapped, arrangements must be made to ensure that all information is effectively communicated. Similarly, an interpreter must be provided if the individual to be sterilized did not understand the language of the consent form or of the person obtaining the consent.

(6) At least thirty days, but not more than one hundred eighty days have passed between the date of the informed consent and the date of the sterilization, except in the case of premature delivery or emergency abdominal surgery. An individual may consent to be sterilized at the time of a premature delivery or emergency abdominal surgery, if at least seventy-two hours have passed since he/she gave informed consent for the sterilization. In the case of premature delivery, the informed consent must have been given at least thirty days before the expected date of delivery. It should be noted that the above waiver does not apply to cases of unanticipated abortions, since, unlike situations involving emergency abdominal surgery or premature delivery, an abortion in the first trimester of pregnancy is not generally considered a major surgical procedure with consequent double exposure to the risks of major surgery.

(B) Informed consent must be obtained on either the consent form located at the back of the sterilization pamphlets published by the U.S. government printing office, or the department's sterilization "Consent Form" ODHS 3198 (see appendix A of this rule). The primary physician performing the sterilization is responsible for securing the recipient's informed consent for the procedure; however, all invoices submitted to the department for sterilization, whether performed as a primary or secondary procedure, or for medical procedures directly related to such sterilizations, must include a copy of the signed consent form. Reimbursement will not be made for associated services when the sterilization procedure itself is not eligible for reimbursement, regardless of whether or not the procedure is itself billed to the department. The physician may sign and date the consent to sterilization form either before or after the date the procedure is performed. The date the physician signs the form cannot be prior to the date that the recipient signs the form. Informed consent must not be obtained while the individual to be sterilized is:

(1) In labor or childbirth; or

(2) Seeking to obtain or obtaining an abortion; or

(3) Under the influence of alcohol or other substances that affect the individual's state of awareness.

(C) Sterilization by hysterectomy.

(1) Reimbursement cannot be made for hysterectomy procedures when the primary intent of the hysterectomy is for fertility control. Payment will only be made for those hysterectomies performed for medical reasons, such as a diseased uterus, and only if the recipient has been advised orally and in writing prior to surgery that sterility will result. Acknowledgment of the receipt of this information must be obtained by completing section II of the department's approved "Consent to Hysterectomy" form ODHS 3199 (see appendix B of this rule). The primary physician performing the hysterectomy is responsible for securing the recipient's consent to the procedure. As in the case of sterilizations, all invoices submitted to the department for hysterectomies, whether performed as a primary or secondary procedure, or for medical procedures directly related to such hysterectomies, must include a copy of the signed approved hysterectomy consent form. Reimbursement will not be made for associated services when the hysterectomy procedure itself is not eligible for reimbursement, regardless of whether or not the hysterectomy procedure is itself billed to the department. The recipient may sign the consent form either before or after the surgery as long as she was informed of the consequences of the procedure orally and in writing prior to surgery.

(2) Payment can be made for a hysterectomy without obtaining signed acknowledgment of the hysterectomy consent form in the following circumstances:

(a) The individual was already sterile before the hysterectomy; or

(b) The individual was postmenopause; or

(c) The individual requires a hysterectomy because of a life-threatening emergency situation in which the physician determines that prior acknowledgment is not possible.

In either situation, where the exceptions apply, the primary physician performing the surgery must certify by completing section III on the ODHS 3199 that the individual was already sterile at the time of the hysterectomy and state the cause of the sterility; or, certify that the hysterectomy was performed under a life-threatening emergency situation in which he determined that prior acknowledgment was not possible. The primary physician must also include a description of the nature of the emergency.

(3) Reimbursement is also available for hysterectomies performed during a period of an individual's retroactive eligibility if the physician certifies that all the requirements are met by completing section IV on the ODHS 3199. In a case where signed acknowledgment by the recipient or her representative is required, section II of the ODHS 3199 must also be completed.

(4) If a recipient requiring a hysterectomy is eligible for both medicaid and medicare, an acknowledgment statement or certification of exception must be obtained. The properly completed ODHS 3199 form must not be attached to the medicare claim form, but must be forwarded separately to the Ohio department of human services (ODHS). If the claim is rejected by medicare, the provider should submit a separate invoice to ODHS with the medicare rejection attached. The date that the ODHS 3199 form was sent to ODHS should be entered in the provider remarks section of the medicaid invoice.

(D) All claims for both sterilizations and sterilizations by hysterectomy must be billed on an invoice. No direct entry claims will be accepted.

Invoices received for both sterilization and sterilization by hysterectomy must comply with the requirements of this rule if they are to be eligible for reimbursement. Invoices which are not in compliance with the requirements of this rule will be denied and returned to providers.

APPENDIX A CONSENT FORM

Notice: Your decision at any time not to be sterilized will not result in the withdrawal or withholding of any benefits provided by programs or projects receiving federal funds. CONSENT TO STERILIZATION

I have asked for and received information about sterilization from ___________________________________. When I first asked for (doctor or clinic)

the information, I was told that the decision to be sterilized is completely up to me. I was told that I could decide not to be sterilized. If I decide not to be sterilized, my decision will not affect my right to future care or treatment. I will not lose any help or benefits from programs receiving Federal funds, such as A.F.D.C. or Medicaid that I am now getting or for which I may become eligible.

I understand that the sterilization must be considered permanent and not reversible. I have decided that I do not want to become pregnant, bear children or father children.

I was told about those temporary methods of birth control that are available and could be provided to me which will allow me to bear or father a child in the future. I have rejected these alternatives and chosen to be sterilized.

I understand that I will be sterilized by an operation known as a _______________. The discomforts, risks and benefits associated with the operation have been explained to me. All my questions have been answered to my satisfaction.

I understand that the operation will not be done until at least thirty days after I sign this form. I understand that I can change my mind at any time and that my decision at any time not to be sterilized will not result in the withholding of any benefits or medical services provided by federally funded programs.

I am at least 21 years of age and was born on ___________________________ Month Day Year I, ______________________________________________, hereby consent of my own free will to be sterilized by ___________________________________ (doctor)

by a method called _________________________. My consent expires 180 days from the date of my signature below.

I also consent to the release of this form and other medical records about the operation to:

Representatives of the Department of Health, Education, and Welfare or

Employees of programs or projects funded by that Department but only for determining if Federal laws were observed.

I have received a copy of this form.

___________________________________________ Date: ____________________ Signature Month Day Year

You are requested to supply the following information, but it is not required:

Race and ethnicity designation (please check) [] American Indian or [] Black (not of Hispanic origin) Alaska Native [] Hispanic [] Asian or Pacific Islander [] White (not of Hispanic origin) INTERPRETER'S STATEMENT

If an interpreter is provided to assist the individual to be sterilized:

I have translated the information and advice presented orally to the individual to be sterilized by the person obtaining this consent. I have also read him/her the consent form in _______________ language and explained its contents to him/her. To the best of my knowledge and belief he/she understood this explanation.

____________________________________________________________________ Interpreter Date STATEMENT OF PERSON OBTAINING CONSENT

Before___________________________________________________signed the name of individual

consent form, I explained to him/her the nature of the sterilization operation _______________, the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.

I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.

I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or any benefits provided by Federal funds.

To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appears to understand the nature and consequence of the procedure.

_____________________________________________________________________ Signature of person obtaining consent Date _____________________________________________________________________ Facility _____________________________________________________________________ Address PHYSICIAN'S STATEMENT

Shortly before I performed a sterilization operation upon _______________________________________________ on ________________________________ Name of individual to be sterilized Date of sterilization ______________________________, I explained to him/her the nature of the operation sterilization operation____________________________________, the fact that specify type of operation

it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.

I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.

I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or benefits provided by Federal funds.

To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appeared to understand the nature and consequences of the procedure.

(Instructions for use of alternative final paragraphs: Use the first paragraph below except in the case of premature delivery or emergency abdominal surgery where the sterilization is performed less than 30 days after the date of the individual's signature on the consent form. In those cases, the second paragraph below must be used. Cross out the paragraph which is not used.)

(1) A least thirty days have passed between the date of the individual's signature on this consent form and the date the sterilization was performed.

(2) This sterilization was performed less than 30 days but more than 72 hours after the date of the individual's signature on this consent form because of the following circumstances (check applicable box and fill in information requested):

[] Premature delivery [] Individual's expected date of delivery: [] Emergency abdominal surgery: (describe circumstances): ______________________________________________________________________ Physician Date ____________________

APPENDIX B Ohio Department of Human Services CONSENT TO HYSTERECTOMY

Note: Type or print clearly. Section I: Identifying Information ___________________________________________________________________ _______________________________________________________________________ Patient's Name Physician's Name ___________________________________________________________________ _______________________________________________________________________ Medicaid Number Provider Number (7-digit) ___________________________________________________________________ _______________________________________________________________________ Date of Surgery Physician's Signature ___________________________________________________________________ _______________________________________________________________________ Section II: Consent (If consent is not required, go on to Section III.) I understand that this hysterectomy, whether performed as a single procedure or together with other procedures, is medically necessary and not to be performed solely for family planning purposes. The fact that the surgery will make me permanently incapable of bearing children in the future has been explained to me orally and in writing [] Consent before surgery - I understand the above statements. [] Consent after surgery - I understand the above statements. They were explained to me orally and in writing before surgery. _________________________________________________________________________________________________________________________________________________ Patient/Representative Signature Date of Signature Person Obtaining Consent (if other than physician) _________________________________________________________________________________________________________________________________________________ Section III. Exceptions [] 1. Priority sterility, explain:_______________________________________________________________________________________________________________ [] 2. Post menopause age_____________________________. [] 3. Patient required a hysterectomy because of a life-threatening emergency in which prior consent was not possible. Explain emergen ?? _________________________________________________________________________________________________________________________________________________ _________________________________________________________________________________________________________________________________________________ Section IV: Retroactive Eligibility At time of the hysterectomy Medicaid eligibility was not established. For retroactive payment check boxes that apply and complete-information requested. [] 1. Patient was informed of the consequences of the procedure and has signed the consent form in Section II. [] 2. Patient was not informed of the consequences of the procedure but: [] Was sterile prior to surgery. Explain __________________________________________________________________________________________________ [] Was post menopause age _________________________. [] Required a hysterectomy because of a life-threatening emergency in which prior consent was impossible. Explain Emergency ______________________________________________________________________________________________________________________ Distribution: One copy to patient; one copy retained by facility; one copy retained by physician; one copy retained by anesthesiologist. FOR REIMBURSEMENT EACH PROVIDER MUST SEND A COPY OF THIS FORM TO OHIO DEPARTMENT OF HUMAN SERVICES