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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations transmitted by the provider or in cases where the recognized amount is determined by a specified State law or All-Payer Model Agreement, such other timeframe as specified under the State law or All-Payer Model Agreement, must determine whether the items and services are covered under the plan or coverage and, if the items and services are covered, send to the provider an initial payment or a notice of denial of payment. For purposes of this paragraph c3, the 30-calendar-day period begins on the date the plan or issuer receives the information necessary to decide a claim for payment for the items or services.
4 Must pay a total plan or coverage payment directly to the nonparticipating provider that is equal to the amount by which the out-of-network rate for the items and services involved exceeds the cost-sharing amount for the items and services as determined in accordance with paragraphs c1 and 2 of this section, less any initial payment amount made under paragraph c3 of this section. The total plan or coverage payment must be made in accordance with the timing requirement described in section 716c6 of ERISA, or in cases where the out-of-network rate is determined under a specified State law or All-Payer Model Agreement, such other timeframe as specified by the State law or All-Payer Model Agreement.
5 Must count any cost-sharing payments made by the participant or beneficiary toward any in-network deductible and in-network out-of-pocket maximums including the annual limitation on cost sharing under section 2707b of the PHS Act as applicable applied under the plan or coverage and the in-network deductible and out-ofpocket maximums must be applied in the same manner as if such cost-sharing payments were made with respect to items and services furnished by a participating provider.
d Applicability date. The provisions of this section are applicable with respect to plan years beginning on or after January 1, 2022.

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2590.7166 Methodology for calculating qualifying payment amount.

a Definitions. For purposes of this section, the following definitions apply:
1 Contracted rate means the total amount including cost sharing that a group health plan or health insurance issuer has contractually agreed to pay a participating provider, facility, or provider of air ambulance services for covered items and services, whether directly or indirectly, including through a third-party administrator or pharmacy benefit manager. Solely for purposes of
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this definition, a single case agreement, letter of agreement, or other similar arrangement between a provider, facility, or air ambulance provider and a plan or issuer, used to supplement the network of the plan or coverage for a specific participant or beneficiary in unique circumstances, does not constitute a contract.
2 Derived amount has the meaning given the term in 2590.7152715A1.
3 Eligible database means i A State all-payer claims database;
or ii Any third-party database which A Is not affiliated with, or owned or controlled by, any health insurance issuer, or a health care provider, facility, or provider of air ambulance services or any member of the same controlled group as, or under common control with, such an entity. For purposes of this paragraph a3iiA, the term controlled group means a group of two or more persons that is treated as a single employer under sections 52a, 52b, 414m, or 414o of the Internal Revenue Code of 1986, as amended;
B Has sufficient information reflecting in-network amounts paid by group health plans or health insurance issuers offering group health insurance coverage to providers, facilities, or providers of air ambulance services for relevant items and services furnished in the applicable geographic region; and C Has the ability to distinguish amounts paid to participating providers and facilities by commercial payers, such as group health plans and health insurance issuers offering group health insurance coverage, from all other claims data, such as amounts billed by nonparticipating providers or facilities and amounts paid by public payers, including the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of the Social Security Act or a demonstration project under title XI of the Social Security Act, or the Childrens Health Insurance Program under title XXI of the Social Security Act.
4 Facility of the same or similar facility type means, with respect to emergency services, either i An emergency department of a hospital; or ii An independent freestanding emergency department.
5 First coverage year means, with respect to an item or service for which coverage is not offered in 2019 under a group health plan or group health insurance coverage offered by a health insurance issuer, the first year after 2019
for which coverage for such item or service is offered under that plan or coverage.

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6 First sufficient information year means, with respect to a group health plan or group health insurance coverage offered by a health insurance issuer i In the case of an item or service for which the plan or coverage does not have sufficient information to calculate the median of the contracted rates described in paragraph b of this section in 2019, the first year after 2022
for which the plan or issuer has sufficient information to calculate the median of such contracted rates in the year immediately preceding that first year after 2022; and ii In the case of a newly covered item or service, the first year after the first coverage year for such item or service with respect to such plan or coverage for which the plan or issuer has sufficient information to calculate the median of the contracted rates described in paragraph b of this section in the year immediately preceding that first year.
7 Geographic region means i For items and services other than air ambulance services A Subject to paragraphs a7iB
and C of this section, one region for each metropolitan statistical area, as described by the U.S. Office of Management and Budget and published by the U.S. Census Bureau, in a State, and one region consisting of all other portions of the State.
B If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph b of this section for an item or service provided in a geographic region described in paragraph a7iA of this section, one region consisting of all metropolitan statistical areas, as described by the U.S. Office of Management and Budget and published by the U.S. Census Bureau, in the State, and one region consisting of all other portions of the State.
C If a plan or issuer does not have sufficient information to calculate the median of the contracted rates described in paragraph b of this section for an item or service provided in a geographic region described in paragraph a7iB of this section, one region consisting of all metropolitan statistical areas, as described by the U.S. Office of Management and Budget and published by the U.S. Census Bureau, in each Census division and one region consisting of all other portions of the Census division, as described by the U.S. Census Bureau.
ii For air ambulance services A Subject to paragraph a7iiB of this section, one region consisting of all metropolitan statistical areas, as described by the U.S. Office of
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