Current through Register Vol. 54, No. 12, March 23, 2024
(a) Payment for covered sterilization
procedures shall be made only if all of the following requirements are met:
(1) The individual requesting sterilization
has voluntarily given informed consent in accordance with all requirements
described in subsection (b) of this section.
(2) The individual is at least 21 years old
at the time informed consent is obtained.
(3) The individual is not a mentally
incompetent individual or an institutionalized individual as defined in §
1221.2 (relating to definitions).
(b) For the purposes of this chapter, an
individual requesting sterilization has voluntarily given informed consent only
if all of the following requirements are met:
(1) The consent form is completed correctly
in accordance with all instructions in the Provider Handbook and within the
time frame specified in subsection (c)(1). See Provider Handbook for a
facsimile of the consent form and for detailed instructions on its
completion.
(2) The person
obtaining informed consent has explained orally all elements of informed
consent as included in the consent to sterilization section of the consent
form.
(3) The person obtaining
informed consent has advised the individual that a decision not to be
sterilized may not result in the withdrawal or withholding of benefits provided
by programs or projects receiving Federal funds and has offered to answer
questions the individual may have concerning the sterilization
procedure.
(4) The individual
providing informed consent has been permitted to have a witness of his choice
present when informed consent is given.
(5) The individual has been offered a
language interpreter, if necessary, or an appropriate interpreter if the
individual is blind, deaf or otherwise handicapped.
(6) Additional State or local laws for
obtaining consent have been met.
(c) A consent form is considered to be
completed correctly only if all of the following requirements are met:
(1) At least 30 days, but no more than 180
days, have passed between the date the individual has given written informed
consent, and the date of the sterilization procedure.
Exception: In the case of a sterilization
performed during emergency abdominal surgery, 72 hours shall have passed
between the time of informed consent and the time of sterilization. In the case
of sterilization performed during premature delivery, informed consent shall
have been given at least 30 days before the expected date of delivery.
(2) The person obtaining informed
consent has properly signed the consent form in accordance with instructions in
the provider handbook on the same date that informed consent is
given.
(3) Another witness or
interpreter has properly signed the consent form in accordance with
instructions in the provider handbook.
(4) The physician performing the
sterilization procedure has certified and signed the physician's statement
section of the consent form after the procedure has been performed.
