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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations health insurance coverage, if the provider or a participating health care facility on behalf on a nonparticipating provider 1 Provides to the participant, beneficiary, or enrollee a written notice in paper or, as practicable, electronic form, as selected by the individual, that contains the information required under paragraph d of this section, provided such written notice is provided:
i In accordance with guidance issued by HHS, and in the form and manner specified in such guidance;
ii With the consent document, and is provided physically separate from other documents and not attached to or incorporated into any other document;
and iii To such participant, beneficiary, or enrollee A Not later than 72 hours prior to the date on which the individual is furnished such items or services, in the case where the appointment to be furnished such items or services is scheduled at least 72 hours prior to the date on which the individual is to be furnished such items and services; or B On the date the appointment to be furnished such items or services is scheduled, in the case where the appointment is scheduled within 72
hours prior to the date on which such items or services are to be furnished.
Where an individual is provided the notice on the same date that the items or services are to be furnished, providers and facilities are required to provide the notice no later than 3 hours prior to furnishing items or services to which the notice and consent requirements apply.
2 Obtains from the participant, beneficiary, or enrollee the consent described in paragraph e of this section to be treated by the nonparticipating provider. An authorized representative may receive the notice on behalf of a participant, beneficiary, or enrollee, and may provide consent on behalf of the participant, beneficiary, or enrollee. For purposes of this section and 149.410, an authorized representative is an individual authorized under State law to provide consent on behalf of the participant, beneficiary, or enrollee, provided that the individual is not a provider affiliated with the facility or an employee of the facility, unless such provider or employee is a family member of the participant, beneficiary, or enrollee. The consent must i Be provided voluntarily, meaning the individual is able to consent freely, without undue influence, fraud, or duress;

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ii Be obtained in accordance with, and in the form and manner specified in, guidance issued by HHS; and iii Not be revoked, in writing, by the participant, beneficiary, or enrollee prior to the receipt of items and services to which the consent applies.
3 Provides a copy of the signed written notice and consent to the participant, beneficiary, or enrollee inperson or through mail or email, as selected by the participant, beneficiary, or enrollee.
d Information required under written notice. The written notice described in paragraph c1 of this section must be provided in the form and manner specified by HHS in guidance, and must 1 State that the health care provider is a nonparticipating provider, with respect to the health plan or coverage.
2 Include the good faith estimated amount that such nonparticipating provider may charge the participant, beneficiary, or enrollee for the items and services involved including any item or service that is reasonably expected to be furnished by the nonparticipating provider in conjunction with such items or services, including notification that the provision of the estimate or consent to be treated under paragraph e of this section does not constitute a contract with respect to the charges estimated for such items and services or a contract that binds the participant, beneficiary, or enrollee to be treated by that provider or facility.
3 Provide a statement that prior authorization or other care management limitations may be required in advance of receiving such items or services at the facility.
4 Clearly state that consent to receive such items and services from such nonparticipating provider is optional and that the participant, beneficiary, or enrollee may instead seek care from an available participating provider, with respect to the plan or coverage, as applicable, and that in such cases the cost-sharing responsibility of the participant, beneficiary, or enrollee would not exceed the responsibility that would apply with respect to such an item or service that is furnished by a participating provider, as applicable, with respect to such plan.
e Consent described to be treated by a nonparticipating provider. The consent described in this paragraph e, with respect to a participant, beneficiary, or enrollee of a group health plan or group or individual health insurance coverage who is to be furnished items or services by a nonparticipating provider, must be documented on a form specified by the
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Secretary, in consultation with the Secretary of Labor, through guidance and provided in accordance with such guidance, that must be signed by the participant, beneficiary, or enrollee before such items and services are furnished and that 1 Acknowledges in clear and understandable language that the participant, beneficiary, or enrollee has been i Provided with the written notice under paragraph c of this section, in the form selected by the participant, beneficiary, or enrollee.
ii Informed that the payment of such charge by the participant, beneficiary, or enrollee might not accrue toward meeting any limitation that the plan or coverage places on cost sharing, including an explanation that such payment might not apply to an innetwork deductible or out-of-pocket maximum applied under the plan or coverage.
2 States that by signing the consent, the individual agrees to be treated by the nonparticipating provider and understands the individual may be balance billed and subject to costsharing requirements that apply to services furnished by the nonparticipating provider.
3 Documents the time and date on which the participant, beneficiary, or enrollee received the written notice described in paragraph c of this section and the time and date on which the individual signed the consent to be furnished such items or services by such nonparticipating provider.
f Language access. 1 A
nonparticipating provider or the participating health care facility on behalf of the nonparticipating provider must provide the individual with the choice to receive the written notice and consent document in any of the 15 most common languages in the State in which the applicable facility is located, except that the notice and consent document may instead be available in any of the 15 most common languages in a geographic region that reasonably reflects the geographic region served by the applicable facility; and 2 If the individuals preferred language is not among the 15 most common languages in which the nonparticipating provider or the participating health care facility on behalf of the nonparticipating provider makes the notice and consent document available and the individual cannot understand the language in which the notice and consent document are provided, the notice and consent criteria in paragraph c of this section are not met unless the nonparticipating
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