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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
demonstration projects under section 1115 of the Social Security Act.
vi Written decision. A The certified IDR entity must explain its determination in a written decision submitted to the parties and the Secretary, in a form and manner specified by the Secretary;
B If the certified IDR entity does not choose the offer closest to the qualifying payment amount, the certified IDR
entitys written decision must include an explanation of the credible information that the certified IDR entity determined demonstrated that the qualifying payment amount was materially different from the appropriate out-of-network rate, based on the considerations allowed under paragraph c4iiiB through D of this section, with respect to the qualified IDR item or service.
vii Effects of determinationA
Binding. A determination made by a certified IDR entity under paragraph c4ii of this section:
1 Is binding upon the parties, in the absence of fraud or evidence of intentional misrepresentation of material facts presented to the certified IDR entity regarding the claim; and 2 Is not subject to judicial review, except in a case described in any of paragraphs 1 through 4 of section 10a of title 9, United States Code.
B Suspension of certain subsequent IDR requests. In the case of a determination made by a certified IDR
entity under paragraph c4ii of this section, the party that submitted the initial notification under paragraph b2 of this section may not submit a subsequent notification involving the same other party with respect to a claim for the same or similar item or service that was the subject of the initial notification during the 90-calendar-day period following the determination.
C Subsequent submission of requests permitted. If the end of the open negotiation period specified in paragraph b1 of this section occurs during the 90-calendar-day suspension period regarding claims for the same or similar item or service that were the subject of the initial notice of IDR
determination as described in paragraph c4vi of this section, either party may initiate the Federal IDR process for those claims by submitting a notification as specified in paragraph b2 of this section during the 30business-day period beginning on the day after the last day of the 90-calendarday suspension period.
viii Recordkeeping requirements.
The certified IDR entity must maintain records of all claims and notices associated with the Federal IDR process
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with respect to any determination for 6
years. The certified IDR entity must make these records available for examination by the plan, issuer, FEHB
carrier, provider, facility, or provider of air ambulance services, or a State or Federal oversight agency upon request, except to the extent the disclosure would violate either State or Federal privacy law.
ix Payment. If applicable, the amount of the offer selected by the certified IDR entity less the sum of the initial payment and any cost sharing paid or owed by the participant or beneficiary must be paid directly to the provider, facility, or provider of air ambulance services not later than 30
calendar days after the determination by the certified IDR entity. If the offer selected by the certified IDR entity is less than the sum of the initial payment and any cost sharing paid by the participant or beneficiary, the provider, facility, or provider of air ambulance services will be liable to the plan or issuer for the difference. The provider, facility, or provider of air ambulance services must pay the difference directly to the plan or issuer not later than 30
calendar days after the determination by the certified IDR entity.
d Costs of IDR process1 Certified IDR entity fee. i With respect to the Federal IDR process described in paragraph c of this section, the party whose offer submitted to the certified IDR entity under paragraph c4iiA
of this section is not selected is responsible for the payment to the certified IDR entity of the predetermined fee charged by the certified IDR entity.
ii Each party to a determination for which a certified IDR entity is selected under paragraph c1 of this section must pay the predetermined certified IDR entity fee charged by the certified IDR entity to the certified IDR entity at the time the parties submit their offers under c4i of this section. The certified IDR entity fee paid by the prevailing party whose offer is selected by the certified IDR entity will be returned to that party within 30
business days following the date of the certified IDR entitys determination.
2 Administrative fee. i Each party to a determination for which a certified IDR entity is selected under paragraph c1 of this section must, at the time the certified IDR entity is selected under paragraph c1 of this section, pay to the certified IDR entity a non-refundable administrative fee due to the Secretary for participating in the Federal IDR
process described in this section.
ii The administrative fee amount will be established in guidance
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published annually by the Secretary in a manner such that the total fees paid for a year are estimated to be equal to the projected amount of expenditures by the Departments of the Treasury, Labor, and Health and Human Services for the year in carrying out the Federal IDR
process.
e Certification of IDR entity1 In general. In order to be selected under paragraph c1 of this sectioni An IDR entity must meet the standards described in this paragraph e and be certified by the Secretary, jointly with the Secretaries of Labor and the Treasury, as set forth in this paragraph e of this section and guidance promulgated by the Secretary. Once certified, the IDR entity will be provided with a certified IDR entity number.
ii An IDR entity must provide written documentation to the Secretary regarding general company information such as contact information, Taxpayer Identification Number, and website, as well as the applicable service area in which the IDR entity intends to conduct payment determinations under the Federal IDR process. IDR entities may choose to submit their application for all States or self-limit to a particular subset of States.
iii An IDR entity that the Secretary, jointly with the Secretary of Labor and the Secretary of the Treasury, certifies must enter into an agreement as a condition of certification. The agreement shall include specified provisions encompassed by this section, including, but not limited to, the requirements applicable to certified IDR
entities when making payment determinations as well as the requirements regarding certification and revocation such as specifications for wind down activities and reallocation of certified IDR entity fees, where warranted.
2 Requirements. An IDR entity must provide written documentation to the Secretary through the Federal IDR portal that demonstrates that the IDR entity satisfies the following standards to be a certified IDR entity under this paragraph e:
i Possess directly or through contracts or other arrangements sufficient arbitration and claims administration of health care services, managed care, billing and coding, medical and legal expertise to make the payment determinations described in paragraph c of this section within the time prescribed in paragraph c4ii of this section.
ii Employ directly or through contracts or other arrangements a sufficient number of personnel to make the determinations described in
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