(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 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, beneficiary, or enrollee in unique circumstances, does not constitute a contract.
(2)
Derived amount— has the meaning given the term in
§ 147.210 of this subchapter.
(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 (a)(3)(ii)(A), the term controlled group means a group of two or more persons that is treated as a single employer under sections 52(a), 52(b), 414(m), or 414(o) 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 or individual 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 or individual 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 Children's 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 or individual 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.
(6)
First sufficient information year— means, with respect to a group health plan or group or individual 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
(a)(7)(i)(B) 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 (a)(7)(i)(A) 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 (a)(7)(i)(B) 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 (a)(7)(ii)(B) 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, determined based on the point of pick-up (as defined in
42 CFR 414.605).
(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 air ambulance service provided in a geographic region described in
paragraph (a)(7)(ii)(A) 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, determined based on the point of pick-up (as defined in
42 CFR 414.605).
(8)
Insurance market— is, irrespective of the State, one of the following:
(i)
The individual market (other than short-term, limited-duration insurance or individual health insurance coverage that consists solely of excepted benefits).
(ii)
The large group market (other than coverage that consists solely of excepted benefits).
(iii)
The small group market (other than coverage that consists solely of excepted benefits).
(iv)
In the case of a self-insured group health plan, all self-insured group health plans (other than account-based plans, as defined in
§ 147.126(d)(6)(i) of this subchapter, and plans that consist solely of excepted benefits) of the same plan sponsor, or at the option of the plan sponsor, all self-insured group health plans administered by the same entity (including a third-party administrator contracted by the plan), to the extent otherwise permitted by law, that is responsible for calculating the qualifying payment amount on behalf of the plan.
(9)
Modifiers— mean codes applied to the service code that provide a more specific description of the furnished item or service and that may adjust the payment rate or affect the processing or payment of the code billed.
(10)
Newly covered item or service means an item or service for which coverage was not offered in 2019 under a group health plan or group or individual health insurance coverage offered by a health insurance issuer, but that is offered under the plan or coverage in a year after 2019.
(11)
New service code means a service code that was created or substantially revised in a year after 2019.
(12)
Provider in the same or similar specialty means the practice specialty of a provider, as identified by the plan or issuer consistent with the plan's or issuer's usual business practice, except that, with respect to air ambulance services, all providers of air ambulance services are considered to be a single provider specialty.
(13)
Same or similar item or service means a health care item or service billed under the same service code, or a comparable code under a different procedural code system.
(14)
Service code means the code that describes an item or service using the Current Procedural Terminology (CPT) code, Healthcare Common Procedure Coding System (HCPCS), or Diagnosis-Related Group (DRG) codes.
(15)
Sufficient information— means, for purposes of determining whether a group health plan or health insurance issuer offering group or individual health insurance coverage has sufficient information to calculate the median of the contracted rates described in
paragraph (b) of this
section—
(i)
The plan or issuer has at least three contracted rates on January 31, 2019, to calculate the median of the contracted rates in accordance with
paragraph (b) of this section; or
(ii)
For an item or service furnished during a year after 2022 that is used to determine the first sufficient information year—
(A)
The plan or issuer has at least three contracted rates on January 31 of the year immediately preceding that year to calculate the median of the contracted rates in accordance with
paragraph (b) of this section; and
(B)
The contracted rates under
paragraph (a)(15)(ii)(A) of this section account (or are reasonably expected to account) for at least 25 percent of the total number of claims paid for that item or service for that year with respect to all plans of the sponsor (or the administering entity as provided in
paragraph (a)(8)(iv) of this section, if applicable) or all coverage offered by the issuer that are offered in the same insurance market.
(16)
Qualifying payment amount— means, with respect to a sponsor of a group health plan or health insurance issuer offering group or individual health insurance coverage, the amount calculated using the methodology described in
paragraph (c) of this section.
(17)
Underlying fee schedule rate means the rate for a covered item or service from a particular participating provider, providers, or facility that a group health plan or health insurance issuer uses to determine a participant's, beneficiary's, or enrollee's cost-sharing liability for the item or service, when that rate is different from the contracted rate.
(18)
Downcode means the alteration by a plan or issuer of a service code to another service code, or the alteration, addition, or removal by a plan or issuer of a modifier, if the changed code or modifier is associated with a lower qualifying payment amount than the service code or modifier billed by the provider, facility, or provider of air ambulance services.
(d)
Information to be shared about the qualifying payment amount. In cases in which the recognized amount, for an item or service furnished by a nonparticipating provider or nonparticipating emergency facility, is the qualifying payment amount or the amount billed by the provider or facility, or if the amount on which cost sharing is based for air ambulance services furnished by a nonparticipating provider of air ambulance services is the qualifying payment amount or the amount billed by the provider of air ambulance services, the plan or issuer must provide to the provider, facility, or provider of air ambulance services, as applicable, in writing, in paper or electronic form—
(1)
With each initial payment or notice of denial of payment under
§ 149.110,
§ 149.120, or
§ 149.130:
(i)
The qualifying payment amount for each item or service involved;
(ii)
If the qualifying payment amount is based on a downcoded service code or modifier—
(A)
A statement that the service code or modifier billed by the provider, facility, or provider of air ambulance services was downcoded;
(B)
An explanation of why the claim was downcoded, which must include a description of which service codes were altered, if any, and a description of which modifiers were altered, added, or removed, if any; and
(C)
The amount that would have been the qualifying payment amount had the service code or modifier not been downcoded;
(iii)
A statement to certify that, based on the determination of the plan or issuer—
(A)
The qualifying payment amount applies for purposes of the recognized amount (or, in the case of air ambulance services, for calculating the participant's, beneficiary's, or enrollee's cost sharing); and
(B)
Each qualifying payment amount shared with the provider or facility was determined in compliance with this section;
(iv)
A statement that—
(A)
If the provider, facility, or provider of air ambulance services, as applicable, wishes to initiate a 30-business-day open negotiation period for purposes of determining the out-of-network rate, the provider, facility, or provider of air ambulance services must:
(1) Contact the appropriate person or office to initiate open negotiation generally within 30 business days of receiving the initial payment or notice of denial of payment, and
(2) For disclosures required to be provided on or after the later of August 3, 2026 and the date that the open negotiation notice can be submitted through the Federal independent dispute resolution (IDR) portal, notify the Secretary as described under § 149.510(b)(1)(i); and
(B)
If the 30-business-day open negotiation period does not result in an agreement on the amount of payment, the provider, facility, or provider of air ambulance services may generally initiate the Federal IDR process within 4 business days after the end of the 30-business-day open negotiation period;
(v)
For disclosures required to be provided on or after August 3, 2026, the legal business name (if any) of the self-insured group health plan, FEHB Program carrier, or issuer and, if applicable, the legal business name of the self-insured group health plan sponsor, and the registration number assigned to the plan or issuer, as required under
§ 149.530.
(vi)
Contact information, including a telephone number and email address, for the appropriate person or office to initiate open negotiations for purposes of determining an amount of payment (including cost sharing) for such item or service.
(2)
In a timely manner upon the request of the provider, facility, or provider of air ambulance services—
(i)
Information about whether the qualifying payment amount for items and services involved included contracted rates that were not on a fee-for-service basis for those specific items and services and whether the qualifying payment amount for those items and services was determined using underlying fee schedule rates or a derived amount;
(ii)
If a plan or issuer uses an eligible database under
paragraph (c)(3) of this section to determine the qualifying payment amount, information to identify which database was used; and
(iii)
If a related service code was used to determine the qualifying payment amount for an item or service billed under a new service code under paragraph
(c)(4)(i) or
(ii) of this section, information to identify the related service code; and
(iv)
If applicable, a statement that the plan's or issuer's contracted rates include risk-sharing, bonus, penalty, or other incentive-based or retrospective payments or payment adjustments for the items and services involved (as applicable) that were excluded for purposes of calculating the qualifying payment amount.