N.J. Admin. Code § 10:54-5.41

Current through Register Vol. 56, No. 9, May 6, 2024

Section 10:54-5.41 - Sterilization; general

(a) The Division covers sterilization procedures performed on Medicaid/NJ FamilyCare program beneficiaries based on Federal regulations ( 42 CFR 441.250 through 441.258 ) and related requirements outlined in this section and in the billing instructions. For sterilization policy and procedures, see (b) through (e) below. Billing instructions are outlined in the Fiscal Agent Billing Supplement.

(b) "Sterilization" means any surgical procedure, treatment, or operation, for the purpose of rendering an individual permanently incapable of reproducing. Surgical sterilization procedures are those whose primary purpose is to render an individual incapable of reproducing. Surgical sterilization procedures require the completion of the Federal "Consent Form" for sterilization.

(c) In accordance with 42 CFR 441.258 Appendix to Subpart F (Specific Requirements for Use), the following requirements shall be met and/or documented on the Consent Form prior to the sterilization of an individual:

1. The individual is at least 21 years of age at the time the consent is obtained;

2. The individual is not mentally incompetent. "Mentally incompetent individual" means an individual 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;

3. The individual is not institutionalized. "Institutionalized individual" means an individual who is:

i. 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

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

4. The individual has voluntarily given informed consent;

5. At least 30 days, but not more than 180 days, have passed between the date of informed consent and the date of sterilization, except in the case of emergency abdominal surgery or premature delivery;

i. In the case of emergency abdominal surgery at least 72 hours shall have passed between the date he or she gave informed consent and the date of sterilization;

ii. In the case of premature delivery, informed consent shall have been given at least 30 days before the expected date of delivery and at least 72 hours have passed between the date of informed consent and the date of premature delivery.

6. In the case where a patient desires to be sterilized at the time of delivery, the Consent Form shall be signed by the patient no earlier than the 5th month of pregnancy to minimize the possibility of exceeding the 180 day limit.

(d) An individual is considered to have given informed consent for sterilization only if:

1. The person who obtained consent for the sterilization procedure offered to answer any questions the individual to be sterilized may have had or has concerning the procedure, provided a copy of the Consent Form, and provided orally all of the following information or advice to the individual to be sterilized:

i. Advice that the individual is free to withhold or withdraw consent to the procedure at any time before 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; and

ii. A description of available alternative methods of family planning birth control; and

iii. Advice that the sterilization procedure is considered to be irreversible; and

iv. A thorough explanation of the specific sterilization procedure to be performed; and

v. A full description of the discomfort and risks that may accompany or follow the performing of the procedure, including an explanation of type and possible effects of any anesthetic to be used; and

vi. A full description of the benefits or advantages that may be expected as a result of the sterilization; and

vii. Advice that the sterilization will not be performed for at least 30 days except for emergency abdominal surgery or premature delivery.

2. Suitable arrangements were made to insure that the information specified by this rule was effectively communicated to any individual who is blind, deaf, or otherwise handicapped; and

3. An interpreter was provided if the individual to be sterilized did not understand the language used on the Consent Form or the language used by the person obtaining consent;

4. The individual to be sterilized was permitted to have a witness of his or her own choice present when consent was obtained;

5. The requirements of the Consent Form were met, such as, its contents, certification, and signatures (see (e) below).

Note: The Consent Form currently in use by the Division is a replica of the form contained in the Federal Regulations and is to be utilized by providers when submitting claims. No other consent form is permitted unless approved by the Secretary, United States Department of Health and Human Services. The form is available from the fiscal agent.

(e) In addition to completing all information (name of doctor or clinic the patient received information from, name of the operation to be performed, the patient's birth date, name of the patient, name of the physician who will perform the sterilization, the method, the language used by an interpreter, name and address of the facility the person obtaining consent is associated with, the date of the sterilization and the specific type of operation) in the appropriate spaces provided, the form must be signed and dated by hand as specified below:

1. "Consent to Sterilization" shall be signed and dated by the individual to be sterilized, prior to the sterilization operation (in accordance with the time frames specified in 10:54-5.41(c)5.

2. "Interpreter's Statement" shall be signed and dated by the interpreter, if one was provided prior to the sterilization operation. The interpreter shall certify by signing and dating the "consent form" that:

i. He or she translated the information presented orally and read the Consent Form and explained its contents to the individual to be sterilized; and

ii. To the best of the interpreter's knowledge and belief, the individual understood what the interpreter told him or her.

3. "Statement of Person Obtaining Consent" shall be signed and dated by the person who obtained the consent, prior to the sterilization operation. The person securing the Consent Form shall certify, by signing and dating the Consent Form that:

i. Before the individual signed the "consent form", he or she advised the individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized; and

ii. He or she explained orally the requirements for informed consent as set forth on the Consent Form; and

iii. To the best of his or her knowledge and belief, the individual to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized. The name and address of the facility or physician's office with which the person obtaining consent is associated must be completed in the space provided on the form.

4. "Physician's Statement" shall be signed and dated by the physician who performed the sterilization operation, after the surgery has been performed. (A date prior to surgery is not acceptable.) The physician performing the sterilization shall certify, by signing and dating the Consent Form, that within 24 hours before the performance of the sterilization operation:

i. The physician advised the individual to be sterilized that no Federal benefits may be withdrawn from the patient because of the decision not to be sterilized; and

ii. The physician explained orally the requirements for informed consent as set forth on the Consent Form; and

iii. To the best of the physician's knowledge and belief, the individual appeared mentally competent, and knowingly and voluntarily consented to be sterilized; and

iv. That at least 30 days have passed between the date of the individual's signature on the Consent Form and certified the date upon which the sterilization was performed, except in the case of emergency abdominal surgery or premature delivery; and

v. In the case of emergency abdominal surgery or premature delivery performed within 30 days of consent, the physician must certify that the sterilization was performed less than 30 days, but not less than 72 hours after informed consent was obtained, and in the case of abdominal surgery must describe the emergency, or in the case of premature delivery, must state the expected date of delivery.

5. Any additional requirement of State or local law for obtaining consent, except a requirement for spousal consent, was followed.

6. Informed consent may not be obtained while the individual to be sterilized is:

i. In labor or childbirth; or

ii. Seeking to obtain or obtaining an abortion; or

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

(f) Any New Jersey physician with electronic billing capabilities shall submit a "hard copy" of the CMS 1500 claim form (including for inpatient and outpatient services) for all sterilization claims with the "Consent Form" attached to the CMS 1500 claim form and must not submit the claim through EMC claim processing.

N.J. Admin. Code § 10:54-5.41

Amended by R.2001 d.51, effective 2/5/2001.
See: 32 N.J.R. 3929(a), 33 N.J.R. 555(a).
In (a), substituted "beneficiaries" for "recipients" following "performed on Medicaid".
Amended by R.2012 d.124, effective 7/2/2012.
See: 43 N.J.R. 1477(a), 44 N.J.R. 1884(a).
In the introductory paragraph of (a), inserted "/NJ FamilyCare program" and deleted "42 CFR" preceding "441.258"; and in (f), substituted "CMS" for "HCFA" twice.