1210-0169 Tri-dept PRA supporting statement 4.25.2022 FINAL

Independent Dispute Resolution Process

OMB Control No. 1210-0169

Expiration Date: 04/30/2022

SUPPORTING STATEMENT FOR PAPERWORK REDUCTION ACT 1995:

INDEPENDENT DISPUTE RESOLUTION PROCESS

This information collection request (ICR) seeks approval for a revision of an existing control number.

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA), which includes the No Surprises Act, was signed into law. The No Surprises Act provides Federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently.

The CAA added provisions applicable to group health plans and health insurance issuers in the group and individual markets in a new Part D of title XXVII of the Public Health Service Act (PHS Act) and also added new provisions to part 7 of the Employee Retirement Income Security Act (ERISA), and Subchapter B of chapter 100 of the Internal Revenue Code (Code). Section 102 of the No Surprises Act added Code section 9816, ERISA section 716, and PHS Act section 2799A-1, which contain limitations on cost sharing and requirements for initial payments for emergency services. Section 103 of the No Surprises Act amended Code section 9816, ERISA section 716, and PHS Act section 2799A-1 to establish a Federal independent dispute resolution (Federal IDR) process that nonparticipating providers or facilities and group health plans and health insurance issuers in the group and individual market may use following the end of an unsuccessful open negotiation period to determine the out-of-network rate for certain qualified items and services. More specifically, the Federal IDR process may be used to determine the out-of-network rate for emergency services and nonemergency items and services furnished by nonparticipating providers at participating health care facilities where an All-Payer Model Agreement or specified State law does not apply. Section 105 of the No Surprises Act created Code section 9817, ERISA section 717, and PHS Act section 2799A-2, which contain limitations on cost sharing and requirements for initial payments for air ambulance services and allow plans and issuers and providers of air ambulance services to access the Federal IDR process. CAA provisions that apply to health care providers and facilities and providers of air ambulance services, such as requirements around cost sharing, prohibitions on balance billing for certain items and services, and requirements related to disclosures about balance billing protections, were added to title XXVII of the PHS Act in a new part E.

The Office of Personnel Management (OPM) interim final rules amend existing 5 CFR 890.114(a) to include references to the Department of the Treasury (Treasury), Department of Labor (DOL), and Department of Health and Human Services (HHS) (collectively, the Departments) interim final rules to clarify that pursuant to 5 U.S.C. 8902(p), Federal Employees Health Benefits (FEHB) carriers are also subject to the Federal IDR process set forth in those regulations with respect to a qualified item or service eligible for determination through open negotiation and the Federal IDR process furnished by a carrier offering a health benefits plan in the same manner as those provisions apply to a group health plan or health insurance issuer offering group or individual health insurance coverage, subject to 5 U.S.C. 8902(m)(1) and the provisions of the carrier’s contract. Through new 5 CFR 890.114(d), OPM adopts the Departments’ interim final rules as conformed by terms unique to the FEHB Program. In 5 CFR 890.114(d), OPM adopts the Departments’ rules as necessary to properly integrate with existing FEHB Program structure and sets forth circumstances in which OPM will enforce these rules as applied to FEHB carriers. The OPM interim final rules require carrier notice to the OPM Director (herein, the Director) of a carrier’s intent to initiate, or receipt of a provider’s notice to initiate, the Federal IDR process. The Director will coordinate with the Departments in matters regarding FEHB carriers requiring resolution under the Federal IDR process and with respect to oversight of certified IDR entities’ reports regarding FEHB carriers. As discussed in the July 2021 interim final rule, all out-of-network rate determinations regarding qualified IDR items or services eligible for determination through open negotiation or the Federal IDR process under the No Surprises Act with respect to FEHB plans or carriers that are not resolved by open negotiation are subject to the Federal IDR process unless OPM contracts with FEHB carriers include terms that adopt State law as governing for this purpose.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The information requirements of the interim final rules have 26 components, described below. The requirements consist of notices necessary for the Federal IDR process, requirements are associated with the certification of IDR entities, and reporting requirements for certified IDR entities. The time frames for these notices may be modified under extenuating circumstances. See Code section 9816(c)(9), ERISA section 716(c)(9), and PHS Act section 2799A-1(c)(9). These notices also apply to FEHB carriers. These forms also pertain to health care provider and facility requirements to inform uninsured (or self-pay) individuals both verbally and in writing of the availability of a good faith estimate of expected charges (45 CFR 149.610) as well as a patient-provider dispute resolution process for uninsured (or self-pay) individuals who receive a final bill from a provider or facility that is substantially in excess than the furnished good faith estimate (45 CFR 149.620).

1. Open Negotiation Notice. Before accessing the Federal IDR process to determine the out-of-network rate for a qualified item or service, the parties must engage in a 30-business-day open negotiation period to attempt to reach an agreement regarding the total out-of-network rate (including any cost sharing).  To initiate the open negotiation period, the initiating party must provide notice to the other party within 30 business days of the receipt of the initial payment or notice of denial of payment for the qualified item or service. The Departments have issued a standard notice that the parties must use to satisfy the open negotiation notice requirement. The “Open Negotiation Notice” must include information sufficient to identify the items or services subject to negotiation, including the date the item or service was furnished, the service code, the initial payment amount or notice of denial of payment, as applicable, an offer for the out-of-network rate, and contact information for the party sending the “Open Negotiation Notice.”

2. Notice of IDR Initiation. When the parties do not reach an agreed-upon amount for the out-of-network rate by the last day of the open negotiation period, either party may initiate the Federal IDR process by submitting the “Notice of IDR Initiation” to the other party and to the Departments during the 4-business-day period beginning on the 31st business day after the start of the open negotiation period. An FEHB carrier must also notify the OPM Director. The Departments issued a standard notice that the parties must submit through the portal. The “Notice of IDR Initiation” must include: (1) information sufficient to identify the qualified IDR items or services (and whether the qualified IDR items or services are designated as batched items and services), including the dates and location of the items or services, the type of qualified IDR items or services (such as emergency services, post-stabilization services, professional services, hospital-based services), corresponding service and place-of-service codes, the amount of cost sharing allowed, and the amount of the initial payment made by the plan or issuer for the qualified IDR items or services, if applicable; (2) the names and contact information of the parties involved, including email addresses, phone numbers, and mailing addresses; (3) the State where the qualified IDR items or services were furnished; (4) the commencement date of the open negotiation period; (5) the initiating party’s preferred certified IDR entity; (6) an attestation that the items or services are qualified IDR items and services within the scope of the Federal IDR process; (7) the qualifying payment amount (QPA); (8) information about the QPA as described in 26 CFR 54.9816-6T(d), 29 CFR 2590.716-6(d), and 45 CFR 149.140(d);¹ and (9) general information describing the Federal IDR process.

3. Notice of Certified IDR Entity Selection. The parties to the Federal IDR process may jointly select a certified IDR entity not later than 3 business days following the date of initiation of the Federal IDR process. The initiating party must notify the Departments by electronically submitting the “Notice of the Certified IDR Entity Selection or Failure” to select (as applicable), no later than 1 business day after the end of the 3-business-day period (or, in other words, 4 business days after the date of initiation of the Federal IDR process) through the Federal IDR portal. In addition, in instances in which the non-initiating party believes that the Federal IDR process is not applicable, that party must notify the Departments through the Federal IDR portal on the same timeframe that the “Notice of Selection (or failure to select)” is required and provide information regarding the lack of applicability. If the parties have agreed on a certified IDR entity, the “Notice of the Certified IDR Entity Selection” must include the following information: (1) the name of the certified IDR entity; (2) the certified IDR entity number; and (3) an attestation by both parties (or by the initiating party if the other party did not respond) that the selected certified IDR entity does not have a conflict of interest.

4. Notice of Agreement on an Out-of-Network Rate. If the parties to the Federal IDR process agree on an out-of-network rate for a qualified IDR item or service after providing a “Notice of IDR Initiation” to the Departments, but before the certified IDR entity has made its payment determination, the initiating party must send a notification to the Departments and to the certified IDR entity (if selected) electronically in a form and manner specified by the Departments in guidance, such as through the Federal IDR portal, as soon as possible but no later than 3 business days after the date of the agreement. The notification must include the out-of-network rate (that is, the total payment amount, including both cost sharing and the total plan or coverage payment) and signatures from an authorized signatory for each party.

5. Notice of Offer. Not later than 10 business days after the selection of the certified IDR entity, the plan, issuer, or FEHB carrier and the nonparticipating provider, emergency facility, or provider of air ambulance services must each submit a written offer to the certified IDR entity. This offer must be expressed as both a dollar amount and the corresponding percentage of the qualifying payment amount (QPA) represented by that dollar amount, to facilitate the certified IDR entity reporting the offer as a percentage of the QPA to the Departments. Where batched items and services have different QPAs, the parties should provide these different QPAs and may provide different offers for these batched items and services, provided that the same offer should apply for all items and services with the same QPA. Parties to the Federal IDR process must also submit information requested by the certified IDR entity relating to the offer. This information must, at a minimum, include the information described in 26 CFR 54.9816-8T(c)(4)(i)(A)(2), 29 CFR 2590.716-8(c)(4)(i)(A)(2), and 45 CFR 149.510(c)(4)(i)(A)(2). The provider must specify whether the provider, practice, or organization has fewer than 20 employees, 20 to 50 employees, 51 to 100 employees, 101 to 500 employees, or more than 500 employees. For facilities, the facility must specify whether the facility has 50 or fewer employees, 51 to 100 employees, 101 to 500 employees, or more than 500 employees. Providers and facilities must also provide information on the practice specialty or type, respectively (if applicable). Plans and issuers must provide the coverage area of the plan or issuer, the relevant geographic region for purposes of the QPA, and, for group health plans, whether they are fully insured, or partially or fully self-insured (or an FEHB carrier, if the item or service relates to FEHB coverage). Parties may also submit any information relating to the offer submitted by either party except that the information may not include information related to usual and customary charges, the amount that would have been billed if the protections of the No Surprises Act had not applied, or public payor rates. The Departments intend for the Federal IDR portal to collect this information as part of the offer submission process, such that certified IDR entities will not have to directly request this information.

6. IDR Payment Determination. Not later than 30 business days after the selection of the certified IDR entity, the certified IDR entity must notify the plan, issuer, or FEHB carrier and the provider, facility, or provider of air ambulance services of the selection of the offer and provide the written decision to the parties and the Departments.

7. Request of Extension of Time Periods for Extenuating Circumstances. The time periods specified in the interim final rules (other than the timing of the payments following a final determination or settlement,) may be extended in the case of extenuating circumstances at the Departments’ discretion on a case-by-case basis if the extension is necessary to address delays due to matters beyond the control of the parties or for good cause. Parties may request an extension by submitting a request for extension due to extenuating circumstances through the Federal IDR portal, including an explanation of the extenuating circumstances that necessitate an extension and which Federal IDR process time period(s) are the subject of the request. The party requesting the extension must attest that prompt action will be taken to ensure that the payment determination under this section is made as soon as administratively practicable.

8. IDR Certification. The interim final rules provide that an IDR entity must provide written documentation to the Departments that demonstrates that the entity satisfies certain standards and procedures outlined in the interim final rules and set forth in guidance issued by the Departments. The guidance indicates the types of documentation that should be submitted for each certification standard, in what manner they should be submitted, and how what the Departments will require for certification. The required certification documentation will be submitted by IDR entities through an application on the Federal IDR portal. An IDR entity that satisfies the standards in the interim final rules and guidance issued by the Departments will be assigned a certified IDR entity number and will be certified for a 5-year period. IDR entities will need to be recertified every 5 years.

9. Petition for Denial or Revocation. An individual, provider, facility, provider of air ambulance services, plan, issuer, or FEHB carrier may petition for the denial of a certification of an IDR entity or a revocation of a certification of a certified IDR entity for failure to meet the requirements of Code section 9816(c), ERISA section 716(c), PHS Act section 2799A-1(c), or the interim final rules. The petitioner must submit a written petition to the Departments that identifies the IDR entity seeking certification or the certified IDR entity that is the subject of the petition and outlines the reasons for the petition. The petition must also specify whether the petition seeks denial or revocation of a certification and must be signed by the petitioner. The petitioner must use the standard petition notice issued by the Departments and submit any supporting documentation for consideration by the Departments. The Departments will make public the list of IDR entities seeking certification, as well as the list of certified IDR entities, to help facilitate the petition process.

10. Administrative Fee. Under Code section 9816(c)(8), ERISA section 716(c)(8), PHS Act section 2799A-1(c)(8), and the interim final rules, each party to a determination must pay an administrative fee for participating in the Federal IDR process. The interim final rules require each party to pay the administrative fee to the certified IDR entity at the time the certified IDR entity is selected, regardless of whether that certified IDR entity was selected by the parties or by the Departments.

11. Breach and Incident Notification. An IDR entity must report any actual or suspected breach of unsecured individually identifiable health information (IIHI) to the CMS IT Service Desk by telephone at (410) 786-2580 or 1-800-562-1963 or via email notification at [email protected] within 24 hours from discovery of the breach. Incidents must be reported to the CMS IT Service Desk by the same means as breaches within 72 hours from discovery of the actual or suspected incident. For this purpose, “security incident” or “incident” has the meaning contained in OMB Memoranda M 17-12 (January 3, 2017) and means an occurrence that, in relation to an IDR entity’s information technology system that stores and maintains unsecured IIHI: (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or the information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.

An IDR entity must, following the discovery of a breach or potential breach of unsecured IIHI, notify the applicable provider, facility, or provider of air ambulance services; the applicable plan, issuer, or FEHB carrier; the Departments; and the Office of Personnel Management (OPM) in instances where the breach relates to IIHI of FEHB covered individuals, as applicable.

If an actual or attempted acquisition, access, use, or disclosure of unsecured IIHI in a manner not permitted under 26 CFR 54.9816-8T(e)(2)(v), 29 CFR 2590.716-8(e)(2)(v), and 45 CFR 149.510(e)(2)(v) is discovered, an IDR entity must conduct a risk assessment as described in 26 CFR 54.9816-8T(a)(2)(ii)(B), 29 CFR 2590.716-8(a)(2)(ii)(B), and 45 CFR 149.510(a)(2)(ii)(B), and notify the Departments of the potential or actual breach and provide to the Departments (and OPM, if applicable), in written form through the federal IDR portal its risk assessment determination as to whether any actual or suspected breach of unsecured IIHI, occurred within five business days from discovery of the breach, and whether there is likely a high or low probability this breach occurred. Further, the IDR Entity must notify the CMS IT Service Desk by telephone at (410) 786-2580 or 1-800-562-1963 or via email notification at [email protected], regarding its risk assessment determination as to whether any actual or suspected breach of unsecured IIHI, occurred within five business days from discovery of the breach, and whether there is likely a high or low probability this breach occurred.

If an actual or attempted acquisition, access, use, or disclosure of unsecured IIHI in a manner not permitted under 26 CFR 54.9816-8T(e)(2)(v), 29 CFR 2590.716-8(e)(2)(v), and 45 CFR 149.510(e)(2)(v) is discovered and an IDR entity finds there is a high probability that the security or privacy of unsecured IIHI has been compromised based on a risk assessment as described in 26 CFR 54.9816-8T(a)(2)(ii)(B), 29 CFR 2590.716-8(a)(2)(ii)(B), and 45 CFR 149.510(a)(2)(ii)(B), then an IDR entity must provide notification of the breach or potential breach, without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach or potential breach, to: the Departments (and OPM, if applicable); the plan, issuer, or FEHB carrier; the provider, facility, or provider of air ambulance services, as applicable; and each individual whose unsecured IIHI has been, or is reasonably believed to have been, subject to the breach. Additionally, an IDR entity must share the results of any risk assessment, including the probability that the security or privacy of IIHI has been compromised, with the Departments (and OPM, if applicable).

12. Recordkeeping Requirements. A certified IDR entity must maintain records of relevant documentation associated with any Federal IDR process determination for 6 years. This recordkeeping requirement will help ensure that State and Federal oversight agencies are able to audit past determinations of certified IDR entities and that parties are able to obtain records of the determinations. Certified IDR entities must make these records available for examination by all parties to the dispute, except when disclosure would violate State or Federal privacy laws and regulations, as well as to State or Federal oversight agencies upon request for oversight purposes.

13. Monthly IDR Entity Reporting Requirements. Within 30 business days of the close of each month, each certified IDR entity must report certain data and information in a form and manner specified by the Departments. The report will be submitted through the Federal IDR portal. This information is to be processed by the Departments and published on the Departments’ websites for each calendar quarter. For non-air ambulance items and services, certified IDR entities must report the number of Notices of IDR Initiation submitted to the certified IDR entity during the preceding month and the number of Notices of IDR Initiation for which the certified IDR entity made a final determination. In instances where the provider or facility submits the “Notice of Initiation, the certified IDR entity must submit information on the size of the provider practices or facilities submitting notifications. With respect to each “Notice of IDR Initiation,” the certified IDR entity should provide a description of the items and services included with respect to the notification, including the relevant billing and service codes. The certified IDR entity must also report the relevant geographic region for purposes of the QPA for the qualified items and services with respect to which the “Notice of IDR Initiation” was provided. Certified IDR entities must also report, for each determination, the offers submitted by the disputing parties expressed as both a dollar amount and the corresponding percentage of the QPA represented by that dollar amount, and whether the offer selected by the certified IDR entity was submitted by the plan or issuer, or the provider or facility. The certified IDR entity must report the amount of the selected offer expressed as a dollar amount and as a percentage of the QPA. Where batched items and services have multiple QPAs, the certified IDR entities must report the offer as a percentage of each QPA that applied with respect to the batched items and services to which the offer applied. The certified IDR entity must report the number of times the out-of-network rate determined exceeded the QPA. The certified IDR entity must report the rationale for the determination. For each determination, the certified IDR entity must also report the practice specialty or type of each provider or facility involved in furnishing the items and services at issue as well as each party’s name and address. For each determination, the certified IDR entity must also report the number of business days between the selection of the certified IDR entity and the payment determination. Finally, the certified IDR entity must report the total amount of certified IDR entity fees paid to the certified IDR entity during the preceding month. This total amount of certified IDR entity fees should not include amounts refunded by the certified IDR entity to the prevailing party or the administrative fees that are collected on behalf of the Departments.

14. With respect to claims involving air ambulance services, the certified IDR entity must report the number of notifications submitted to the certified IDR entity that pertain to air ambulance services during the preceding month; the number of such notifications with respect to which a final determination was made; and the number of times the out-of-network rate determined (or agreed to) exceeded the QPA for air ambulance services. With respect to each “Notice of IDR Initiation”, the certified IDR entity must provide a description of each air ambulance service, including the relevant billing and service codes and point of pick-up (as defined in 42 CFR 414.605) for the services included in such notification, the amount of the offer submitted by the group health plan, health insurance issuer, or FEHB carrier and by the nonparticipating provider of air ambulance services expressed as a dollar amount and as a percentage of the QPA; whether the offer selected by the certified IDR entity was the offer submitted by the plan or issuer or by the provider of air ambulance services; and the amount of the offer so selected, expressed as a percentage of the QPA. The certified IDR entity must report the rationale for the certified IDR entity’s decision. Additionally, the certified IDR entity must identify the air ambulance vehicle type, including whether the vehicle is fixed wing or rotary wing (information which should be included in the relevant service code), and the clinical capability level of such vehicle (if the parties have provided such information); the identity of the plan, issuer, carrier, or provider of air ambulance services with respect to such notification, providing each party’s name and address; and the number of business days elapsed between selection of the certified IDR entity and the selection of the payment amount by the certified IDR entity. Finally, the certified IDR entity must also report the total amount of certified IDR entity fees paid to the certified IDR entity for the preceding month. This total amount of certified IDR entity fees should not include amounts refunded by the certified IDR entity to prevailing parties.

15. Standard Form: “Good Faith Estimate for Health Care Items and Services” Under the No Surprises Act. This form may be used by the health care providers and facilities to inform uninsured (or self-pay) individuals of the expected charges for receiving certain health care items and services. A good faith estimate must be provided within 3 business days upon request. Information regarding scheduled items and services must be furnished within 1 business day of scheduling an item or service to be provided in at least 3 business days; and within 3 business days of scheduling an item or service to be provided in at least 10 business days.

16. Standard Form: PPDR Dispute Initiation Form. This notice will be used by health care providers and facilities to initiate a payment dispute. The eligibility of the dispute for the PPDR process will be verified. It will also be determined whether any conflict of interest exists with the independent dispute resolution entity selected to decide the dispute.

17. Standard Form: Online PPDR Initiation Form. This notice will be used by health care providers and facilities to initiate a payment dispute. The eligibility of the dispute for the PPDR process will be verified. It will also be determined whether any conflict of interest exists with the independent dispute resolution entity selected to decide the dispute.

18. Standard Notice: Ineligible for Patient-Provider Dispute Resolution or Additional Information Needed. This notice will be used by SDR entities to inform an uninsured (or self-pay) individual or their authorized representative that the uninsured (or self-pay) individual is not eligible for dispute resolution or that their submission to initiate dispute resolution was incomplete. If the submission is incomplete, the notice informs the uninsured (or self-pay) individual or their authorized representative of what is required to establish eligibility for dispute resolution.

19. Patient-Provider Selected Dispute Resolution (SDR) Entity Certification Application Data Elements. This document identifies data elements that an organization seeking to become an SDR entity is required to include in the contracting process. The SDR entity must be certified by the Secretary under 45 CFR 149.620(d).

20. Independent Dispute Resolution and Patient-Provider Dispute Resolution Processes; Vendor Management Data Elements. This document identifies data elements that an IDR Entity will be required to provide to HHS so that the IDR Entity can pay the required administrative fee.

21. Patient-Provider Dispute Resolution Process Data Elements. This document identifies the data elements that an uninsured (or self-pay) individual, provider, or facility is required to include in the patient-provider dispute resolution process under 45 CFR 149.620.

22. Standard Notice: Selected Dispute Resolution (SDR) Determination Notice to Parties Provided Under the No Surprises Act. This notice is to be used by the SDR entities to notify the uninsured (or self-pay) individual and the health care provider or health care facility whether the difference between the billed amount and the “Good Faith Estimate” is justified or not in accordance with the regulatory determination process and what amount the uninsured individual is to pay the health care provider or health care facility.

23. Standard Notice: Selected Dispute Resolution (SDR) Entity Notification to Health Care Providers and Facilities and Uninsured (or Self-Pay) Individuals. This is a standard notice so that providers or facilities and uninsured (or self-pay) individuals are informed of the SDR entity selection. Once HHS assigns an SDR entity to a dispute, the SDR entity must inform both parties (the uninsured (or self-pay) individual and the health care provider or health care facility) of the selection. Additionally, the SDR entity must request that the health care provider submit specific information within 10 business days of receipt of the notice so the SDR entity can use the data to make a determination on the dispute. To use this standard notice, the SDR entity, must fill in the blanks with the appropriate information.

24. Standard Notice: Uninsured (or Self-Pay) Individual and Provider or Facility Settle on a Payment Amount After Initiating Patient Provider Dispute Resolution. This notice is for use by the health care provider or facility to notify the SDR entity in the event that both parties agree to settle on a payment amount after the patient-provider dispute resolution process has been initiated and prior to the SDR entity making a determination. While the determination by the SDR entity is pending, the two (2) parties to the patient-provider dispute resolution process (the uninsured (or self-pay) individual and their authorized representative and the health care provider or health care facility) may agree to resolve the dispute by settling on a payment amount. When the parties settle on the amount, federal standards require the provider or facility to notify the SDR entity no later than three (3) business days after the date of the agreement.

25. Standard Notice: Selected Dispute Resolution (SDR) Entity Notification to Health Care Provider or Facility and Uninsured (or Self-Pay) Individual Confirming Receipt of Dispute Settlement and Action. This notice is for use by the SDR entity to notify the health care provider or facility and uninsured (or self-pay) individual that the settlement agreement has been received and the dispute is closed or the SDR entity requires additional information from the parties. Any point after the dispute resolution process has been initiated but before the date on which a determination is made by the SDR entity, the parties can settle the payment amount through either an offer of financial assistance or an offer to accept a lower amount, or an agreement by the uninsured (or self-pay) individual to pay the billed charges in full. In the event that the parties agree to settle on a payment amount, the provider or facility should notify the SDR entity through the federal IDR Portal, electronically, or in paper form, as soon as possible, but no later than 3 business days after the date of the agreement.

26. Standard Notice: Uninsured (or Self-Pay) Individual, Provider or Facility’s Notification to Secretary of Health and Human Services Requesting Extension. This notice can be used by the uninsured or (self-pay) individual or the provider or facility to request an extension from HHS. An uninsured (or self-pay) individual can request an extension at any step in the patient-provider dispute resolution process by submitting a request due to extenuating circumstances to the Secretary of HHS via the federal IDR portal, or electronic or paper mail. If the uninsured (or self-pay) individual is able to demonstrate the extension is necessary to address delays due to matters beyond their control or for good cause, the Secretary has the discretion to provide such an extension. A provider or facility may request an extension after the patient-provider dispute resolution has started. Once a dispute has been initiated, the parties may request an extension by submitting a request for extension due to extenuating circumstances through the Federal IDR portal, or electronic or paper mail if the extension is necessary to address delays due to matters beyond the control of the parties or for good cause.

Extensions cannot be granted on payment-related deadlines, including payment of the administrative fee. Once the patient-provider dispute resolution process has started, the Secretary will consider granting extensions in the following circumstance: (i) An extension is necessary to address delays due to matters beyond the control of the parties or for good cause; and (ii) The parties attest that prompt action will be taken to ensure that the determination under this section is made as soon as administratively practicable under the circumstances. To use this standard notice, the uninsured or (self-pay) individual or the provider or facility must provide the asked for information in the space allotted.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration for using information technology to reduce burden.

The interim final rules do not restrict plans, issuers, or FEHB carriers from using electronic technology to provide notices. Parties may provide the Open Negotiation Notice and the “Notice of IDR Initiation” to the other party electronically if the initiating party has a good faith belief that the electronic method is readily accessible by the other party, and the notice is provided in paper form free of charge upon request.

Additionally, many of the requirements described above, including notices, petitions, and reporting will be shared electronically through the Federal IDR portal. The Departments have established the Federal IDR portal to administer the Federal IDR Process, available at https://www.nsa-idr.cms.gov. The Federal IDR portal must be used to satisfy various requirements, including initiation of the Federal IDR Process, selection of a certified IDR entity, and the submission of offers. Use of the Federal IDR portal will allow certified IDR entities and the Departments to ensure the timeline and process requirements of the Federal IDR Process are being met.

The Government Paperwork Elimination Act (GPEA) requires agencies to allow customers the option to submit information or transact with the government electronically, when practicable. Where feasible, and subject to resource availability and resolution of legal issues, the DOL has implemented the electronic acceptance of information submitted by customers to the Federal government.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

The interim final rules and the No Surprises Act amend and add provisions to existing rules under the PHS Act, ERISA, and the Code. Several States already have their own balance billing protections or IDR processes. However, only HHS has jurisdiction over non-Federal government plans and small group and individual market plans in States that do not enforce the applicable provisions of the PHS Act, and the DOL has jurisdiction over ERISA-covered group health plans. The Internal Revenue Service has exclusive jurisdiction over certain church plans. OPM has jurisdiction over the FEHB plans, which are Federal governmental plans, and OPM both contracts with and regulates the carriers with respect to those plans. To limit duplication, qualified IDR items or services under the regulation are limited to items or services for which an out-of-network rate is not determined by reference to a specified State law or an All-Payer Model Agreement. Thus, there will be no duplication of effort with other Federal government agencies or State governments.

5. If the collection of information impacts small businesses or other small entities describe any methods used to minimize burden.

Small issuers, plans, FEHB carriers, providers, facilities, providers of air ambulance services, and certified IDR entities will need to satisfy the same requirements under the interim final rules; however, these costs are scalable to the number of Federal IDR process payment determinations an entity is involved in. The interim final rules permit same or similar items and services to be batched together in a single arbitration proceeding to encourage efficiency. Batched items and services must be billed by the same provider or group of providers or facility or same provider of air ambulance services; payment for the items and services must be made by the same group health plan or health insurance issuer; the items and services must be the same or similar items or services; and all the items and services must have been furnished within the same 30-business-day period. By batching similar claims, the interim final rules may reduce the per-service cost of arbitration and potentially the aggregate administrative costs, since the arbitration process is likely to exhibit at least some economies of scale. For example, the per-service cost of an arbitration case involving ten claims is likely to be less costly than the per-service cost of an arbitration case involving five claims. Accordingly, costs are likely to be lower for smaller providers and entities.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The interim final rules implement certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). Accordingly, not conducting these information collections or conducting these information collections less frequently will prevent the Departments from fulfilling the requirements of these provisions.

Because the Federal IDR process depends on the sending and receiving of notices, discontinuing or reducing the frequency of these notices will not be possible. Without these notices, the Departments will be unable to meet the statutory requirements of PHS Act sections 2799A-1(c) and 2799A-2(b); ERISA sections 716(c) and 717(b); and Code sections 9816(c) and 9817(b).

The certification of IDR entities and the ability of parties to petition for denial of an IDR entity’s certification or the revocation of a certified IDR entity’s certification ensure that certified IDR entities meet a certain quality level. Certified IDR entities are required to be recertified every 5 years; extending this time period would decrease oversight of the performance of certified IDR entities.

The interim final rules require certified IDR entities to report data on a monthly basis to the Departments. If certified IDR entities were required to report their activity less frequently, the Departments would not be able to monitor Federal IDR processes as closely, which could harm individuals, plans, issuers, FEHB carriers, providers, facilities, and providers of air ambulance services, and could cause harms to the wider health care market. This would also affect the ability of the Departments to report certain information on their public websites as is required under the No Surprises Act.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

• requiring respondents to report information to the agency more often than quarterly;

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and 2 copies of any document;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than 3 years;

• in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

The interim final rules require each certified IDR entity to report specified information on the Federal IDR process payment determinations to the Departments on a monthly basis. Additionally, for certification, IDR entities must submit descriptions of their organizational structures and capabilities, including an organizational chart, and the credentials, responsibilities, and number of personnel employed to make payment determinations. Finally, the interim final rules require the parties participating in the Federal IDR process to provide the required notices to the IDREs, parties, and to the Departments. This information is required to efficiently conduct the Federal IDR process within the timeframes allowed by statute.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years -- even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

The Department’s notice required by 5 CFR 1320.8(d), which provided the public with 60 days to comment on the information collection, was published in the Federal Register on October 7, 2021 (86 FR 55980).

The Department has received 5,492 comments (https://www.federalregister.gov/documents/2021/10/07/2021-21441/requirements-related-to-surprise-billing-part-ii). It should be noted that most of these comments were not on the PRA.

One comment suggested the IDR notices should be fully delivered electronically and should not be required to be delivered through mail. In response, the Department clarifies that the IFR did not state that IDR notices must be delivered through mail. The IFR states that parties have the option to deliver the notices both through mail and electronic means.

The comment also suggested to expand the list of data elements in the open negotiation form to include the following: claim number, provider’s first and last name (professional providers), provider group name (professional providers), facility name (facility providers), provider NPI, plan name, and member first and last name. In response to the comment, the Department has added the NPI and provider’s name to the open negotiation form, and the NPI to the Notice of IDR Initiation. The Department has also added the claim number, which this comment has also requested.

Finally, another comment stated the Department underestimated the number of IDR cases will be submitted per year. However, the comment did provide any evidence or rationale for the underestimation, that would allow the estimate to be revised.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

No payments or gifts are provided to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

In order to meet the requirements of certification, certified IDR entities are required to maintain the confidentiality of IIHI obtained in the course of conducting payment determinations.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

There are no questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information. The statement should:

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

• If this request for approval covers more than 1 form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item 14.

Group health plans, health insurance issuers, FEHB carrier, and providers are responsible for complying with the interim final rules. The Department assumes that the burden would primarily fall on providers and issuers, since they would be sending the notifications. Accordingly, in the discussion below, the Departments refer to costs for plans, issuers, and FEHB carriers. However, it is expected that most self-insured group health plans will work with a third-party administrator (TPA) to meet the requirements of these interim final rules.

The Departments recognize the potential that some of the largest self-insured plans may seek to meet the requirements of the interim final rules in-house and not use a TPA or other third party; in such cases those plans will incur the estimated burden and cost directly.

Federal IDR Process for Nonparticipating Providers or Nonparticipating Emergency Facilities

The Departments estimate that 17,435 claims will be submitted annually as part of the Federal IDR process each year.

The Departments estimate that 25 percent of disputes will be resolved in open negotiation before entering the Federal IDR process. The Departments request data or comments on this assumption. Accordingly, the Departments estimate that 23,247 claims will go through open negotiation.² The Departments estimate that it will take on average a medical and health services manager 2 hours to write each “Open Negotiation Notice” and a clerical worker 15 minutes to prepare and send the notice. The burden for each plan, issuer, and FEHB carrier would be 2.25 hours, with an equivalent cost of approximately $224. For all 23,247 claims subject to the interim final rules proceeding through the Federal IDR process, the annual burden would be 52,305 hours, with an associated equivalent cost of $5.2 million.³ The “Open Negotiation Notice” must be sent within 30 business days beginning on the day the provider or facility receives an initial payment or a notice of denial of payment from the plan or issuer regarding such item or service.

When the parties do not reach an agreed-upon amount for the out-of-network rate by the last day of the open negotiation period, either party may initiate the Federal IDR process by submitting the Notice of IDR Initiation to the other party and to the Departments during the 4-business day period beginning on the 31st business day after the start of the open negotiation period. The Departments estimate that it will take 2 hours for a medical and health services manager to write the “Notice of IDR Initiation” and 15 minutes for a clerical worker to prepare and send the initiating notice. The burden for each plan, issuer, and FEHB carrier would be 2.25 hours, with an equivalent cost of approximately $224. For the 17,435 claims initiating the Federal IDR process, the annual burden would be 39,229 hours, with an annual equivalent cost estimate of $3.9 million.⁴

If the parties to the Federal IDR process agree on an out-of-network rate for a qualified IDR item or service after providing notice to the Departments of initiation of the Federal IDR process, but before the certified IDR entity has made its payment determination, the initiating party must send a notification to the Departments and to the certified IDR entity (if selected) electronically through the Federal IDR portal, in a form and manner specified by the Departments, as soon as possible, but no later than 3 business days after the date of the agreement. This notification should include the out-of-network rate for the qualified IDR item or service and signatures from authorized signatories for both parties. The Departments assume that 1 percent of IDR payment determinations will be resolved by an agreement on an out-of-network rate after the Federal IDR process has been initiated. The Departments estimate that it will take on average a medical and health services manager 30 minutes to write each “Open Negotiation Notice” and a clerical worker 15 minutes to submit the notice to the Federal IDR portal. The burden for each plan, issuer, and FEHB carrier would be 45 minutes, with an equivalent cost of approximately $66. For the 174 payment determinations resolved in this manner, the annual burden would be 131 hours, with an associated equivalent cost of $11,538.⁵

If the parties select a certified IDR entity, or if they fail to select a certified IDR entity, they must notify the Departments of their selection no later than 1 business day after the selection or failure to select. To the extent the non-initiating party does not believe that the Federal IDR process applies, the non-initiating party must also provide information that demonstrates the lack of applicability by the same date that the notice of selection or failure to select must be submitted. The Departments estimate that in 25 percent of IDR payment determinations, there will be a failure to select a certified IDR entity. The Departments assume that it will take 1 hour for a medical and health services professional to write the notice and 15 minutes for a clerical worker to prepare and send the notice. The burden for each plan, issuer, and FEHB carrier would be 1.25 hours, with an equivalent cost of approximately $119. For the 4,359 claims that will have a certified IDR entity selected by the disputing parties, the annual burden would be 5,449 hours, with an annual equivalent cost estimate of $0.5 million.⁶

The Departments estimate that in 75 percent of IDR payment determinations, a certified IDR entity will be selected by the disputing parties. Additionally, the Departments assume that it will take 1 hour for a medical and health services professional to write the notice and 15 minutes for a clerical worker to prepare and send the notice. The burden for each plan, issuer, and FEHB carrier would be 1.25 hours, with an equivalent cost of approximately $119. For the 13,076 claims that will have a certified IDR entity selected by the disputing parties, the annual burden would be 16,345 hours, with an annual equivalent cost estimate of $1.6 million.⁷

If the parties fail to select a certified IDR entity, the Departments will select a certified IDR entity that charges a fee within the allowed range of IDR entity costs (or, if there is an insufficient number of certified IDR entities available that charge a fee within the allowed range, the Departments will select a certified IDR entity that has approval to charge a fee outside of that range) through a random selection method. The Departments estimate that in 25 percent of IDR payment determinations, a certified IDR entity will not be selected by the parties.

Additionally, no later than 10 business days after the date of selection of the certified IDR entity with respect to a payment determination for a qualified IDR item or service, the parties must submit to the certified IDR entity an offer for a payment amount for the qualified IDR item or service though the Federal IDR portal. The Departments estimate that for providers and issuers it will take an average of 2.5 hours for a medical and health services manager to write the offer and 30 minutes for a clerical worker to prepare and send the offer. The burden for each plan, issuer, and FEHB carrier would be 3 hours, with an equivalent cost of approximately $290. For the 17,435 payment determinations that will go through submission of offer, the annual burden would be 104,610 hours, with an annual equivalent cost estimate of $10.1 million.⁸

Summary

The total hour burden associated with the Federal IDR process for nonparticipating provider and nonparticipating facility claims, excluding nonparticipating providers of air ambulance services, is 218,068 hours with an equivalent cost of $21,305,979.

Half of the burden associated with the Federal IDR process for hospital and emergency departments is estimated to be allocated to health care plans, issuers, and FEHB carriers, and the other half is estimated to be allocated to health care providers and facilities. As HHS, DOL, the Department of the Treasury, and OPM share jurisdiction. HHS will account for 45 percent of the burden, DOL and the Department of the Treasury will each account for 25 percent of the burden, and OPM will account for 5 percent of the burden.

The hour burden associated with DOL requirements is estimated to be approximately 54,517 hours at an equivalent cost of $5,326,495.

Federal IDR Process for Air Ambulance

According to the March 2020 Health Insurance Coverage Bulletin (HCCI), in 2019, 216.2 million individuals had private health insurance.⁹ In 2017, HCCI estimated that, on average, there were 33.2 air ambulance uses per 100,000 people,¹⁰ and the Government Accountability Office (GAO) estimated that approximately 69 percent of air transports resulted in an out-of-network bill.¹¹ The Departments do not have data on what percent of out-of-network bills will proceed to the Federal IDR process; however, given the nature of air ambulance services, the Departments assume that the percentage will be substantially higher than for hospital or emergency department claims. The Departments assume that 10 percent of out-of-network claims for air transport will end up in the Federal IDR process.

Accordingly, the government estimates there will be 4,968 air ambulance service claims submitted to the Federal IDR process each year.¹² In the interim final rules, air ambulance services are subject to the same requirements for hospital and emergency services in 26 CFR 54.9816-8T, 29 CFR 2590.716-8, and 45 CFR 149.510 (as applicable), except that the items and services for which the requirements of (b)(1) of that section apply shall be understood to be out-of-network air ambulance services, and “qualified IDR items and services” are understood to be air ambulance services.

The Departments estimate that 4,968 air transport disputes will be handled by the Federal IDR process each year, but the Departments estimate that 25 percent of disputes will be resolved in open negotiation before entering the Federal IDR process. Accordingly, the Departments estimate that 6,624 transport payment determinations will enter into open negotiation.¹³ The Departments estimate that it will take an average of 2 hours for a medical and health services manager to write each “Open Negotiation Notice” and 15 minutes for a clerical worker to prepare and send the notice. The burden for each plan, issuer, and FEHB carrier would be 2.25 hours, with an equivalent cost of approximately $224. For 6,624 payment determinations that will enter into open negotiation, the annual burden would be 14,903 hours, with an annual equivalent cost estimate of $1.5 million.¹⁴ The “Open Negotiation Notice” must be sent within 30 business days beginning on the day the provider of air ambulance services receives an initial payment or a notice of denial of payment from the plan, issuer, or FEHB carrier regarding the item or service.

For the estimated 4,968 payment determinations that are submitted to the Federal IDR process, the Departments estimate that it will take 2 hours for a medical and health services professional to write the “Notice of IDR Initiation” and 15 minutes for a clerical worker to prepare and send the initiating notice. The burden for each plan, issuer, and FEHB carrier would be 2.25 hours, with an equivalent cost of approximately $224. For the 4,968 payment determinations that will have selected a certified IDR entity, the annual burden would be 11,177 hours, with an annual equivalent cost estimate of $1.1 million.¹⁵

If the parties to the Federal IDR process agree on an out-of-network rate for a qualified IDR item or service after providing a “Notice of IDR Initiation” to the Departments, but before the certified IDR entity has made its payment determination, the initiating party must send a notification to the Departments and to the certified IDR entity (if selected) electronically through the Federal IDR portal, in a form and manner specified by the Departments, as soon as possible, but no later than 3 business days after the date of the agreement. This notification should include the out-of-network rate for the qualified IDR item or service and signatures from authorized signatories for both parties. The Departments assume that 1 percent of payment determinations will be resolved by an agreement on an out-of-network rate after the Federal IDR process has been initiated. The Departments estimate that it will take on average a medical and health services manager 30 minutes to write each “Notice of Open Negotiation” and a clerical worker 15 minutes to submit the notice to the Federal IDR portal. The burden for each plan, issuer, and FEHB carrier would be 45 minutes, with an equivalent cost of approximately $66. For the 50 payment determinations resolved in this manner, the annual burden would be 38 hours, with an associated equivalent cost of $3,316.¹⁶

If the plan, issuer, or FEHB carrier and the nonparticipating provider of air ambulance services select or fail to select a certified IDR entity, they must notify the Departments of their selection or failure to select a certified IDR entity no later than 1 day after such selection or failure. The Departments estimate that in 75 percent of payment determinations, a certified IDR entity will be selected. Additionally, the Departments assume that it will take 1 hour for a medical and health services professional to write the notice and 15 minutes for a clerical worker to prepare and send the notice. The burden for each plan, issuer, and FEHB carrier would be 1.25 hours, with an equivalent cost of approximately $119. Due to the tight turnaround, the Departments assume this notice will be sent electronically through the Federal IDR portal. For the 3,726 payment determinations that will have a selected a certified IDR entity, the annual burden would be 4,658 hours, with an annual equivalent cost estimate of $0.4 million.¹⁷

If the plan, issuer, or FEHB carrier and the provider of air ambulance services fail to select a certified IDR entity, the Departments will select a certified IDR entity that charges a fee within the allowed range of certified IDR entity costs (or, if there is an insufficient number of certified IDR entities available that charge a fee within the allowed range, the Departments will select a certified IDR entity that has approval to charge a fee outside of that range) through a random selection method. The Departments estimate that in 25 percent of IDR payment determinations, a certified IDR entity will not be selected by the parties. For the 1,242 payment determinations that will not have selected a certified IDR entity, the annual burden would be 1,553 hours, with an annual equivalent cost estimate of $0.1 million.¹⁸

Additionally, no later than 10 business days after the date of selection of the certified IDR entity with respect to a determination for a qualified IDR item or service, the provider of air ambulance services, and plan, issuer, or FEHB carrier must submit to the certified IDR entity: (1) an offer for a payment amount for the qualified IDR item or service furnished by the provider of air ambulance services, expressed both as a dollar amount and as a percentage of the QPA; and (2) information as requested by the certified IDR entity relating to the offer. With the information requested by the certified IDR entity, the parties must include: (A) the coverage area of the plan, issuer, or FEHB carrier; the relevant geographic region for purposes of the QPA; (B) whether the coverage is fully insured, or fully or partially self-insured, as applicable; and (C) the QPA. The parties may also submit to the certified IDR entity any information relating to the offer submitted by either party, except that the information may not include information on factors described in paragraph 26 CFR 54.9816-8T(c)(4)(v), 29 CFR 2590.716-8(c)(4)(v), and 45 CFR 149.510(c)(4)(v). The Departments estimate for the parties, it will take an average of 2 hours for a medical and health services manager to write the offer and 15 minutes for a clerical worker to prepare and send the offer. The burden for each plan, issuer, and FEHB carrier would be 2.25 hours, with an equivalent cost of approximately $224. For the 4,968 claims that will go through submission of offers, the annual burden would be 22,354 hours, with an annual equivalent cost estimate of $2.2 million.¹⁹

Summary

The total hour burden associated with the Federal IDR process for air ambulance services is 54,682 hours with an equivalent cost of $5,411,798. Half of the burden associated with the Federal IDR process for air ambulance services is estimated to be allocated to health plans, issuers, FEHB carriers, or TPAs, and the other half is estimated be allocated to air ambulance service providers. The burden associated with the Federal IDR process for air ambulance services is assumed to be shared by the Departments and OPM. HHS is assumed to cover 45 percent of the burden, while DOL and the Department of the Treasury will each cover 25 percent of the burden and OPM will cover 5 percent of the burden.

The hour burden associated with DOL requirements is estimated to be approximately 13,670 hours at an equivalent cost of $1,352,949.

Request of Extension of Time Periods for Extenuating Circumstances

The Departments do not have data on how often entities will request an extension; however, the Departments are of the view that extenuating circumstances will be rare. The Departments assume that 100 plans, issuers, FEHB carriers, providers, facilities, air ambulance services providers, and air ambulance facilities will annually request an extension starting in 2022 by completing the “Request for Extension due to Extenuating Circumstances” form and attesting that prompt action will be taken to ensure the payment determination under this section is made as soon as administratively practical. The Departments estimate that it will take a clerical worker 15 minutes to prepare and send the notice. The annual burden would be 25 hours, with an associated equivalent cost of $1,381.²⁰

Summary

The total hour burden associated with requests for extension is 25 hours with an equivalent cost of $1,381. Half of the burden is estimated to be allocated to health plans, issuers, FEHB carriers, or TPAs, and the other half is estimated be allocated to health care providers, facilities, and providers of air ambulance services. The burden is assumed to be shared by the Departments and OPM. HHS is assumed to cover 45 percent of the burden, while DOL and the Department of the Treasury will each cover 25 percent of the burden, and OPM will cover 5 percent of the burden.

The hour burden associated with DOL requirements is estimated to be approximately 6 hours at an equivalent cost of $345 each.

Total Hour Burden Summary

In the first year, the total annual hour burden associated with the Federal IDR process is 6,809,640 hours with an equivalent cost burden of $732,971,675. In subsequent years, the total annual hour burden associated with the Federal IDR process is 4,066,344 hours with an equivalent cost burden of $412,757,696. Thus, the 3-year average hour burden associated with the IDR entity certification is 4,980,776 hours with an equivalent cost burden of $519,495,689.

The Departments assume that half of the burden associated with the required notices will be allocated to plans, issuers, and FEHB carriers and the other half of the burden will be allocated to providers, facilities, and providers of air ambulance services. The burden of the plans, issuers, and FEHB carriers will be allocated toward the hour burden of DOL, the Department of the Treasury, and OPM, and the burden of the providers, facilities, and providers of air ambulance services will be allocated toward the hour burden of HHS. The burden of IDR entities will be fully allocated toward the cost burden.

For DOL requirements, the total hour burden in the first and subsequent years associated with the Federal IDR process is 68,193 hours with an equivalent cost burden of $3,339,895.

Estimated Annualized Respondent Cost and Hour Burden

Activity	No. of Respondents	No. of Responses per  Respondent	Total Responses	Average Burden (Hours)	Total Burden (Hours)	Hourly  Wage Rate	Total Burden Cost
Federal IDR Process for Services relating to Nonparticipating Providers or Nonparticipating Emergency Facilities
Medical Billing Specialist write the Open Negotiation Notice	5,812	1	5,812	2	11,623	$105.01	$1,220,566
Clerical workers prepare and send Open Negotiation Notice	5,812	1	5,812	15/60	1,453	$55.23	$80,245
Medical Billing Specialist write the Notice of IDR Initiation	4,359	1	4,359	2	8,718	$105.01	$915,425
Clerical workers prepare and send Notice of IDR Initiation	4,359	1	4,359	15/60	1,090	$55.23	$60,183
Medical Billing Specialist writes the Notice of Agreement on an Out-of-Network Rate	44	1	44	30/60	22	$105.01	$2,284
Clerical workers prepare and send Notice of Agreement on an Out-of-Network Rate	44	1	44	15/60	11	$55.23	$601
Medical Billing Specialist writes the Notice for Selecting IDR Entity	3,269	1	3,269	1	3,269	$105.01	$343,278
Clerical workers prepare and send the Notice for Selecting IDR Entity	3,269	1	3,269	15/60	817	$55.23	$45,137
Medical Billing Specialist writes the Notice for Failing to Select IDR Entity	1,090	1	1,090	1	1,090	$105.01	$114,435
Clerical workers prepare and send the Notice for Failing to Select IDR Entity	1,090	1	1,090	0.25	272	$55.23	$15,047
Medical Billing Specialist writes the Offer	8,718	1	8,718	2.5	21,794	$105.01	$2,288,562
Clerical workers prepare and submit the Offer	8,718	1	8,718	0.5	4,359	$55.23	$240,734
Federal IDR Process for Air Ambulance Services
Medical Billing Specialist writes the Open Negotiation Notice	1,656	1	1,656	2	3,312	$105.01	$347,767
Clerical workers prepare and send Notice for Open Negotiation	1,656	1	1,656	0.25	414	$55.23	$22,864
Medical Billing Specialist writes the Notice of IDR Initiation	1,242	1	1,242	2	2,484	$105.01	$260,82
Clerical workers prepare and send Notice of IDR Initiation	1,242	1	1,242	15/60	311	$55.23	$17,148
Medical Billing Specialist writes the Notice of Agreement on an Out-of-Network Rate	12	1	12	30/60	6	$105.01	$656
Clerical workers prepare and send Notice of Agreement on an Out-of-Network Rate	12	1	12	15/60	3	$55.23	$172
Medical Billing Specialist writes the Notice for Selecting IDR Entity	932	1	932	1	932	$105.01	$97,817
Clerical workers prepare and send the Notice for Selecting IDR Entity	932	1	932	15/60	233	$55.23	$12,862
Medical Billing Specialist writes the Notice for Failing to Select IDR Entity	311	1	311	1	311	$105.01	$32,606
Clerical workers prepare and send the Notice for Failing to Select IDR Entity	311	1	311	0.25	78	$55.23	$4,287
Medical Billing Specialist writes the Offer	2,484	1	2,484	2	4,968	$105.01	$521,651
Clerical workers prepare and submit the Offer	2,484	1	2,484	15/60	621	$55.23	$34,296
Request for Extension
Clerical workers prepare and submit the Request for Extension	25	1	25	15/60	6	$55.23	$345
Total (3-year average)	22,428*		36,964**	1.84	68,193	-	$6,679,789

* The total number of respondents was calculated in the following manner: 17,435 (Federal IDR Process for Services relating to nonparticipating providers or nonparticipating emergency facilities) + 4,968 (Federal IDR Process for air ambulance services) + 25 (IDR Entity) = 22,428.

**The total number of responses in the first year was calculated in the following manner: 27,649 (Federal IDR Process for Services relating to nonparticipating providers or nonparticipating emergency facilities) + 9,120 (Federal IDR Process for air ambulance services) + 25 (Request for Extension) + 176 (IDR Entity) = 36,970. The total number of responses in subsequent years was calculated in the following manner: 27,649 (Federal IDR Process for Services relating to nonparticipating providers or nonparticipating emergency facilities) + 9,120 (Federal IDR Process for air ambulance services) + 25 (Request for Extension) + 166 (IDR Entity) = 36,960. Thus, the three-year average number of responses is calculated in the following manner: (36,970 + 36,960 + 36,960)/3 = 36,964.

***Please note that the numbers in the table are rounded.

13. Provide an estimate of the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 or 14).

• The cost estimate should be split into 2 components: (a) a total capital and start-up cost component (annualized over its expected useful life); and (b) a total operation and maintenance and purchase of service component.  The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information.  Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred.  Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities. 

• If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance.  The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate.  In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate. 

• Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

Group health plans, health insurance issuers, FEHB carriers, facilities and providers are responsible for complying with the interim final rules.

In the discussion below, the Departments refer to costs incurred by plans, issuers, and FEHB carriers. However, it is expected that most self-insured group health plans will work with a TPA to meet the requirements of the rules. Accordingly, issuers and TPAs are assumed to incur this cost and burden for most group health plans. The Departments recognize the potential that some of the largest self-insured plans may seek to meet the requirements of the interim final rules in-house and not use a TPA or other third party; in such cases those plans will incur the estimated burden and cost directly.

Federal IDR Process for Nonparticipating Providers or Nonparticipating Emergency Facilities

The Departments estimate that 17,435 claims will be submitted as part of the Federal IDR process each year.

The Departments estimate that 25 percent of disputes will be resolved in open negotiation before entering the Federal IDR process. Accordingly, the Departments estimate that23,247 claims will go through open negotiation.²¹ The Departments assume that 5 percent of these notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $732.²²

When the parties do not reach an agreed upon amount for the out-of-network rate by the last day of the open negotiation period, either party may initiate the Federal IDR process by submitting the “Notice of IDR Initiation” to the other party and to the Departments during the 4-business-day period beginning on the 31st business day after the start of the open negotiation period. The initiating party may furnish the “Notice of IDR Initiation” to the other party electronically if the initiating party has a good faith belief that the electronic method is readily accessible by the other party and the notice is provided in paper form free of charge upon request; the Departments assume that 5 percent of these notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $549.²³

If the plan, issuer, or FEHB carrier and the nonparticipating provider or nonparticipating emergency facility select a certified IDR entity, or if they fail to select a certified IDR entity, they must notify the Departments of their selection no later than 1 business day after such selection or failure to select. To the extent the non-initiating party does not believe that the Federal IDR process applies, the non-initiating party must also provide information that demonstrates the lack of applicability by the same date that the notice of selection or failure to select must be submitted.

The Departments estimate that in 75 percent of IDR payment determinations, a certified IDR entity will be selected by the disputing parties. For the 13,076 claims that will have a certified IDR entity selected by the disputing parties, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $412.²⁴

If the plan, issuer, or FEHB carrier and the nonparticipating provider or nonparticipating emergency facility fail to select a certified IDR entity, the Departments will select a certified IDR entity that charges a fee within the allowed range of IDR entity costs (or, if there is an insufficient number of certified IDR entities available that charge a fee within the allowed range, the Departments will select a certified IDR entity that has approval to charge a fee outside of that range) through a random selection method. The Departments estimate that in 25 percent of IDR payment determinations, a certified IDR entity will not be selected by the parties. For 4,359 payment determinations that will have failed to select a certified IDR entity, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $137.²⁵

Additionally, no later than 10 business days after the date of selection of the certified IDR entity with respect to a payment determination for a qualified IDR item or service, the parties must submit to the certified IDR entity an offer for a payment amount for the qualified IDR item or service though the Federal IDR portal. For the 17,435 payment determinations that will go through submission of offer, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $1,098.²⁶

After the selected certified IDR entity has reviewed the offer, the certified IDR entity must notify the parties of the payment determination, in a form and manner specified by the Departments.²⁷ The Departments estimate that, on average, it will take a physician and medical billing specialist 0.5 hours to prepare the notice at a composite wage rate of $127.45.²⁸ The burden for each certified IDR entity would be 0.5 hours, with an equivalent cost of approximately $64. Thus, the cost burden to prepare this notice for IDR claims will be $1.1 million.²⁹

Additionally, the selected certified IDR entity must provide the payment determination. The Departments also assume that the cost of preparing and delivering this written decision is included in the certified IDR entity fee paid by the provider, facility, plan, issuer, or FEHB carrier.

After a final determination, the certified IDR entity must maintain records of all claims and notices associated with the Federal IDR process for 6 years. The certified IDR entity must store the documents in a manner necessary to meet the requirements of the interim final rules. The certified IDR entities must make such records available for examination by the plan, issuer, FEHB carrier, provider, facility, or State or Federal oversight agency upon request, except where such disclosure would violate State or Federal privacy laws. For the maintenance and recordkeeping of 17,435 claims, the annual cost burden on the certified IDR entity would be $0.5 million.³⁰

Summary

The total cost associated with the Federal IDR process for nonparticipating provider and nonparticipating facility claims, excluding nonparticipating providers of air ambulance services, is $1,595,442.

Half of the burden associated with the Federal IDR process for nonparticipating provider and nonparticipating facility claims, excluding nonparticipating providers of air ambulance services, is estimated to be allocated to health care plans, issuers, and FEHB carriers, and the other half is estimated be allocated to health care providers and facilities. HHS, DOL, the Department of the Treasury, and OPM share jurisdiction. HHS will account for 45 percent of the burden, DOL and the Department of the Treasury will each account for 25 percent of the burden, and OPM will account for 5 percent of the burden.

The total cost burden associated with DOL requirements is estimated to be $398,860.

Federal IDR Process for Air Ambulance Services

The Departments estimate that 6,624 transport payment determinations will enter into open negotiation.³¹ The “Open Negotiation Notice” must be sent within 30 business days beginning on the day the provider of air ambulance services receives an initial payment or a notice of denial of payment from the plan, issuer, or FEHB carrier regarding such item or service. The Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $209.³²

When the parties do not reach an agreed upon amount for the out-of-network rate by the last day of the open negotiation period, either party may initiate the Federal IDR process by submitting the “Notice of IDR Initiation” to the other party and to the Departments during the 4-business-day period beginning on the 31st business day after the start of the open negotiation period. The initiating party may furnish the “Notice of IDR Initiation” to the other party electronically if the initiating party has a good faith belief that the electronic method is readily accessible by the other party and the notice is provided in paper form free of charge upon request. The Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $157.³³

If the parties select or fail to select a certified IDR entity, they must notify the Departments of their selection or failure to select a certified IDR entity no later than 1 day after such selection or failure. The Departments estimate that in 75 percent of payment determinations, a certified IDR entity will be selected. Due to the tight turnaround, the Departments assume this notice will be sent electronically through the Federal IDR portal. For the 3,726 payment determinations that will have a selected a certified IDR entity, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $117.³⁴

If the parties fail to select a certified IDR entity, the Departments will select a certified IDR entity that charges a fee within the allowed range of certified IDR entity costs (or, if there is an insufficient number of certified IDR entities available that charge a fee within the allowed range, the Departments will select a certified IDR entity that has approval to charge a fee outside of that range) through a random selection method. The Departments estimate that in 25 percent of IDR payment determinations, a certified IDR entity will not be selected by the parties. For 1,242 payment determinations that will have failed to select a certified IDR entity, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $39.³⁵

Additionally, no later than 10 business days after the date of selection of the certified IDR entity with respect to a determination for a qualified IDR service, the parties must submit to the certified IDR entity: (1) an offer for a payment amount for the qualified IDR service, expressed both as a dollar amount and as a percentage of the QPA; and (2) information as requested by the certified IDR entity relating to the offer. With the information requested by the certified IDR entity, the parties must include: (A) the coverage area of the plan, issuer, or FEHB carrier; the relevant geographic region for purposes of the QPA; (B) whether the coverage is fully insured, or fully or partially self-insured, as applicable; and (C) the QPA. The parties may also submit to the certified IDR entity any information relating to the offer submitted by either party, except that the information may not include information on factors described in paragraph 26 CFR 54.9816-8T(c)(4)(v), 29 CFR 2590.716-8(c)(4)(v), and 45 CFR 149.510(c)(4)(v). For the 4,968 claims that will go through submission of offers, the Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $313.³⁶

After the certified IDR entity has reviewed the offer, the certified IDR entity must notify the parties of the payment determination.³⁷ The Departments estimate that, on average, it will take a physician and medical billing specialist 0.5 hours to prepare the notice at a composite wage rate of $127.45.³⁸ The burden for each certified IDR entity would be 0.5 hours, with an equivalent cost of approximately $64. Thus, the cost burden to provide this notice for air ambulance claims will be $0.3 million.³⁹

Additionally, the certified IDR entity must provide the payment determination and the reasons for such determination to the Departments. The Departments also assume that the cost of preparing and delivering this written decision is included in the certified IDR entity fee paid by the provider of air ambulance services, plan, issuer, or FEHB carrier.

After a final determination, the certified IDR entity must maintain records of all claims and notices associated with the Federal IDR process for 6 years. The certified IDR entity must make such records available for examination by the parties, or State or Federal oversight agency upon request, except where such disclosure would violate State or Federal privacy laws. The Departments assume it will take 30 minutes for a clerical worker to establish the records for each determination under the Federal IDR process necessary to meet the requirements. The cost burden on each certified IDR entity maintaining records would be 30 minutes, with an equivalent cost of approximately $28. For the maintenance and recordkeeping of 4,968 claims, the annual cost burden would be $0.1 million.⁴⁰

Summary

The total cost burden associated with the Federal IDR process for air ambulance services is $454,601. Half of the burden associated with the Federal IDR process for air ambulance services is estimated to be allocated to health plans, issuers, FEHB carriers, or TPAs, and the other half is estimated be allocated to health care providers. The burden associated with the Federal IDR process for air ambulance services is assumed to be shared by the Departments and OPM. HHS is assumed to cover 45 percent of the burden, while DOL and the Department of the Treasury will each cover 25 percent of the burden, and OPM will cover 5 percent of the burden.

The total cost burden associated with DOL requirements is estimated to be $113,650.

Request of Extension of Time Periods for Extenuating Circumstances

The Departments assume that 100 plans, issuers, FEHB carriers, providers, facilities, or providers of air ambulance services will annually request an extension starting in 2022 by completing the Request for Extension due to Extenuating Circumstances form and attesting that prompt action will be taken to ensure the payment determination under this section is made as soon as administratively practical. The Departments expect these requests to be submitted through the Federal IDR portal, and therefore have not estimated an associated mailing cost.

IDR Entity Certification and IDR Entity Monthly Reporting

An IDR entity must be certified under standards and procedures set forth in guidance promulgated by the Departments. The Departments estimate that there will be 50 entities that seek IDR certification.

To be certified as a certified IDR entity, the entity will need to submit an application through the Federal IDR portal demonstrating that it meets the requirements described in the interim final rules. An IDR entity must provide written documentation to the Departments regarding general company information (such as contact information, TIN, and website), as well as the applicable service area in which the IDR entity intends to conduct payment determinations under the Federal IDR process. The IDR entity must have (directly or through contracts or other arrangements) sufficient arbitration and claims administration, managed care, billing and coding, medical, legal, and other expertise, and sufficient staffing. The IDR entity must also establish processes to ensure against conflicts of interest, including to attesting that such conflicts do not exist, as defined under the interim final rules. The IDR entity will also need to demonstrate its financial stability and integrity. The corresponding paperwork (including 3 years of financial statements) will be submitted through the Federal IDR portal. Finally, each IDR entity that the Departments certify must enter into an agreement with the Departments.

The Departments estimate that on average it will take a medical and health services manager 5.10 hours and a clerical worker 15 minutes to satisfy these requirements for certifications. The burden for each IDR entity would be 5.35 hours, with an equivalent cost of approximately $548. For the 50 IDR entities that will go through certification, this results in a cost burden of $27,468 in the first year.⁴¹

When a certified IDR entity is selected, the certified IDR entity must submit the administrative fee to the Departments on behalf of the parties to the IDR process. The Departments estimate that the time required to complete the information collection is estimated to average a clerical worker 18 hours annually, including the time to review instructions, search existing data resources, gather required data, and complete and review information collection. This results in a cost burden of $49,707.⁴²

Certified IDR entities are required to be recertified every 5 years. The Departments estimate that on average one-fifth of certified IDR entities will need to be recertified each year. Similar to the initial certification process, these certified IDR entities must ensure the processes are established and complete the corresponding paperwork, including the certification agreement, through the Federal IDR portal. The Departments estimate that, on average, it will take a medical and health services manager 2.10 hours and a clerical worker 15 minutes to satisfy the requirement. The burden for each certified IDR entity would be 2.35 hours, with an equivalent cost of approximately $224. For the 10 certified IDR entities that will go through recertification annually, this results in a cost burden of $2,343 in subsequent years.⁴³

The interim final rules permit an individual, provider, facility, provider of air ambulance services, group health plan, issuer, or FEHB carrier to petition for a denial of a certification or for a revocation of a certification of an IDR entity seeking certification or certified IDR entity for failure to meet certain requirements set forth in the interim final rules. The petitioner must submit a written petition to the Departments that identifies the IDR entity seeking certification or the certified IDR entity that is the subject of the petition and outlines the reasons for the petition. The petitioner must use the standard petition notice issued by the Departments and submit any supporting documentation for consideration by the Departments.

The Departments do not have data on how often such a petition might occur; however, the Departments assume that such a petition will be a rare occurrence. The Departments assume that there will be 3 petitions each year, and it will take on average a medical and health services manager 2 hours and a clerical worker 15 minutes to prepare the petition. The burden for each entity submitting petition is estimated to be 2.25 hours, with an equivalent cost of approximately $224. For the 3 petitions, this results in a cost burden of $560.⁴⁴

For each month, certified IDR entities will be required to report information on their activities to the Departments. The required information will include the number of Notices of IDR Initiation submitted to the certified IDR entity under the Federal IDR process during the immediately preceding month; the number of such Notices of IDR Initiation with respect to which a final determination was made; the size of the provider practices and the size of the facilities submitting Notices of IDR Initiation; the number of times the payment amount determined or agreed to exceeded the QPA, specified by items and services; and the total amount of certified IDR entity fees paid to the certified IDR entity.

Additionally, for each “Notice of IDR Initiation for non-air ambulance items and services,” the certified IDR entity must provide a description of the qualified IDR items and services included with respect to the “Notice of IDR Initiation”, including the relevant billing and service codes; the relevant geographic region for purposes of the QPA; the amount of the offer submitted by the plan or issuer (as applicable) and by the provider or facility (as applicable) expressed as a dollar amount and as a percentage of the QPA; whether the offer selected by the certified IDR entity was the offer submitted by the plan or issuer (as applicable) or by the provider or facility (as applicable); the amount of the selected offer expressed as a dollar amount and a percentage of the QPA; the rationale for the certified IDR entity’s decision; the practice specialty or type of each provider or facility (as applicable) involved in furnishing each qualified IDR item or service; the identity for each plan or issuer, and provider or facility, with respect to the determination; and for each determination, the number of business days elapsed between selection of the certified IDR entity and the determination of the out-of-network rate by the certified IDR entity.

For each month, certified IDR entities will be required to report information on their activities to the Departments relating to air ambulance services. The certified IDR entities will be required to provide the number of “Notices of IDR Initiation” submitted under the Federal IDR process that pertain to air ambulance services during the month submitted to the certified IDR entity; the number of such “Notices of IDR Initiation” with respect to which a final determination was made; the number of times the payment amount exceeded the QPA; and the total amount of certified IDR entity fees paid to the certified IDR entity during the month that data was collected with regard to air ambulance services.

With respect to each “Notice of IDR Initiation” involving air ambulance claims, the certified IDR entity must also provide a description of each air ambulance service; the point of pick-up (as defined in 42 CFR 414.605) for which the services were provided; the amount of the offer submitted by the group health plan, health insurance issuer, or FEHB carrier and by the nonparticipating provider of air ambulance services expressed as a dollar amount and a percentage of the QPA; whether the offer selected by the certified IDR entity was the offer submitted by such plan, issuer, or FEHB carrier or by the provider or facility; the amount of the offer so selected expressed as a dollar amount and a percentage of the QPA; the rationale for the certified IDR entity’s decision; the air ambulance vehicle type; the identity of the plan, issuer, FEHB carrier, or provider of air ambulance services with respect to such determination; and the number of business days elapsed between selection of the certified IDR entity and the determination of the payment amount by the certified IDR entity.

For each month, certified IDR entities will be required to report the information on their activity to the Departments. The report will be submitted through the Federal IDR portal. The Departments estimate it will take a medical and health services manager 1hour, on average, to prepare the reports and a clerical worker 15 minutes to prepare and send the report to the Departments each month. The burden for each certified IDR entity would be 1.25 hours, with an equivalent cost of approximately $118. For the 600 IDR entities, the annual burden would be 750 hours, with an equivalent cost burden of $71,291 each year.⁴⁵

The certified IDR entities are required, following the discovery of a breach of unsecured IIHI, to notify of the breach the provider, facility, or provider of air ambulance services; the plan or issuer; the Departments; and each individual who’s unsecured IIHI has been, or is reasonably believed to have been, subject to the breach, to the extent possible. The Departments estimate that three certified IDR entities will have a breach each year. In addition, the Departments estimate that it will take a medical and health services manager 1 hour, on average, to handle the initial breach and follow the required protocols, and that it will take a general and operations manager 45 minutes, on average, to ensure the protocol is executed and adapt policies accordingly. The burden for each certified IDR entity would be 1.75 hours, with an equivalent cost of approximately $197. For the 3 certified IDR entities, this results in a cost burden of $591 each year.⁴⁶ The Departments assume that 5 percent of notices would be mailed and will incur a printing cost of $0.05 per page and $0.58 for postage. Thus, the mailing cost is estimated to be $0.09.⁴⁷

Summary

In the first year, the total cost burden associated with the IDR entity certification process is $149,616. In subsequent years, the total cost burden associated with the IDR entity certification process is $124,491. The 3-year average cost burden associated with the IDR entity certification is $132,866.

The burden associated with the IDR entity certification is shared by HHS, DOL, the Department of the Treasury, and OPM. It is estimated that 45 percent of the burden will be accounted for by HHS, 25 percent of the burden will be accounted for by DOL and the Department of the Treasury each, and 5 percent will be accounted for by OPM.

The cost burden associated with DOL requirements is $37,404 in the first year and $31,123 in subsequent years. The 3-year average cost burden associated with DOL is $33,217 each.

Total Cost Burden Summary

The total cost burden in the first year associated with the Federal IDR process is $2,643,622. In subsequent years, the total cost burden associated with the Federal IDR process is $2,580,693. Thus, the 3-year average cost burden is $2,601,669.

The Departments classify the burden borne by IDR entities and certified IDR entities as a cost burden. For certification, re-certification, and monthly reporting requirements, 45 percent of the burden will be allocated toward the cost burden of HHS, while DOL and the Department of the Treasury will each be allocated 25 percent of the burden, and OPM will be allocated 5 percent of the burden.

The total cost burden in the first year is estimated to be $549,915 and in subsequent years, the total cost burden associated with the Federal IDR process is estimated to be $543,634. Thus, the 3-year average cost burden associated with DOL requirements is $545,727.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13, and 14 in a single table.

The Federal government will incur costs to build and maintain the Federal IDR portal and to implement and administer the Federal IDR process. The annual costs associated with the Federal IDR portal and administering the Federal IDR process are estimated to be $1 million annually.

15. Explain the reasons for any program changes or adjustments reporting in Items 13 or 14.

The change in burden estimate is the result of reporting the annual burden, whereas the 6-month burden total was reported in the most recent emergency submission.

The changes to the forms described below are clarifying edits to the forms and instructions that do not impact the burden.

The Department has made changes to the following forms: Open Negotiation Period Notice, Notice of IDR Initiation, Notice of Certified IDR Entity Selection, Notice of Offer (Data Elements), and Certified IDR Entity Written Determination.

• Open Negotiation Period Notice:

  • In the instructions:

    • Added language indicating that the party initiating the Federal IDR Process should use one Notice of IDR Initiation for each out-of-network visit, except in cases of bundling or batched claims.

  • In the form:

    • Added “Claim number” and “Name of provider, facility, or provider of air ambulance services, and National Provider Identifier (NPI)” to the information required to be included on the form.

• Notice of IDR Initiation:

  • In the instructions:

    • Added language indicating that the party initiating the Federal IDR Process should use one Notice of IDR Initiation for each out-of-network visit, except in cases of bundling or batched claims.

    • Added language indicating that for claims that are subject to a 90-calendar-day suspension period, a party has 30 business days, beginning on the day after the last day of the suspension period. to initiate the Federal IDR Process.

    • Added clarifying language indicating the notice must be furnished to the Departments on the same day it is furnished to the non-initiating party and the federal IDR portal will display the relevant date.

  • In the form:

    • Added language indicating that for claims that are subject to a 90-calendar-day suspension period, a party has 30 business days, beginning on the day after the last day of the suspension period. to initiate the Federal IDR Process.

    • Added clarifying language indicating the notice must be furnished to the Departments on the same day it is furnished to the non-initiating party and the federal IDR portal will display the relevant date

    • Added “Claim number” and “Type of plan” to the information required to be included on the form.

    • Added “Contact Person’s Name,” “Contact Organization if the name is not the same as the Provider or Facility,” and “National Provider Identifier (NPI):” to the health care provider/health care facility/provider of air ambulance services information required to be included on the form.

    • Added language to indicate if there was a denial of payment for the item(s) and/or service(s).

    • Added language for undersigned individual to indicate whether they were a TPA or service provider.

• Notice of Certified IDR Entity Selection:

  • In the data elements:

    • Clarified that the written information on lack of applicability should include an attestation.

  • Added language to clarify that notice requirements will be satisfied by submitting information through the Federal IDR portal.

• Notice of Offer:

  • Added “Dispute reference number, organization name, primary and secondary points of contact (including mailing address, phone numbers and emails) and plan types.” to the Additional Required Information data element.

  • Revised the Additional Optional Information data element information so that it is consistent with the TMA v. HHS district court memorandum opinion and order and new regulatory language; and added clarification that such information cannot include information on the prohibited factors.

  • Separated out the Additional Optional Information for air ambulance services.

  • Added a separate bullet for additional credible information.

• Certified IDR Entity Written Determination:

  • Eliminated language regarding a written decision’s explanation of credible information that the certified IDR entity determined demonstrated that the QPA was materially different from the appropriate out-of-network rate consistent with the TMA v. HHS district court memorandum opinion and order.

  • Clarified that the parties should be identified by name and IDR reference number to the Payment Determination and Batched Payment Determinations data elements.

  • Clarified that each claim should be identified by the claim number to the Batched Payment Determinations data element and clarified that the certified IDR entity should indicate which party prevails in the overall payment determination when each party receives at least one favorable determination.

16. For collections of information whose results will be published, outline plans for tabulation, and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

For each calendar quarter, starting in 2022, the Departments will publish information regarding the Federal IDR process on a public website.

The information will include aggregate statistics, such as the number of notifications submitted; the size of the provider practices and facilities submitting notifications; the number of notifications for which a determination was made; the information basis for such a determination; the number of times the payment amount determined under this subsection exceeds the qualifying payment amount, by items and services; the amount of expenditures made by the Departments during such calendar quarter to carry out the Federal IDR process; the total amount of fees paid; and the total amount of compensation paid to certified IDR entities.

Additionally, for each “Notice of IDR Initiation”, the Departments will publish a

a description of the items and services included with respect to the notification, including the relevant billing and service codes; the relevant geographic region for purposes of the QPA; the amount of the offer submitted by the plan or issuer (as applicable) and by the provider or facility (as applicable) expressed as a percentage of the QPA; whether the offer selected by the certified IDR entity was the offer submitted by the plan or issuer (as applicable) or by the provider or facility (as applicable); the amount of the selected offer expressed as a percentage of the QPA; the rationale for the certified IDR entity’s decision the practice specialty or type of each provider or facility, respectively, involved in furnishing each item or service; the identity for each plan or issuer, and provider or facility, with respect to the notification; and for each determination, the number of business days elapsed between selection of the certified IDR entity and the selection of the out-of-network rate by the certified IDR entity.

The Departments will also publish the number of Notices of IDR Initiation submitted under the Federal IDR process that pertain to air ambulance services during the month submitted to the certified IDR entity; the number of such notifications with respect to which a final determination was made; the number of times the payment amount exceeded the QPA; and the total amount of certified IDR fees paid to the certified IDR entity during the month that data was collected with regard to air ambulance services. With respect to each “Notice of IDR Initiation” involving air ambulance claims, the Departments will publish a description of each air ambulance service, the point of pick-up (as defined in 42 CFR 414.605) for which the services were provided; the amount of the offer submitted by the group health plan, health insurance issuer, or FEHB carrier and by the nonparticipating provider of air ambulance services expressed as a percentage of the QPA; whether the offer selected by the certified IDR entity was the offer submitted by such plan, issuer or carrier or by the provider or facility; the amount of the offer so selected expressed as a percentage of the QPA; the rationale for the certified IDR entity’s decision; the air ambulance vehicle type; the identity of the plan, issuer, FEHB carrier, or provider of air ambulance services with respect to such notification; and the number of business days elapsed between selection of the certified IDR entity and the selection of the payment amount by the certified IDR entity. The calculation of these statistics will be a tabulation of the monthly reports submitted by IDR entities.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

The OMB expiration date will be published in the Federal Register following OMB approval. The OMB Control Number will be on the homepage of the portal.

18. Explain each exception to the certification statement identified in Item 19.

There are no exceptions to the certification statement.

B. COLLECTIONS OF INFORMATON EMPLOYING STATISTICAL METHODS. 

Not applicable.

1 To satisfy the requirement to provide information about the QPA, the parties should attach the information on the QPA provided under 26 CFR 54.9816-6T(f)(1)(v)(C), 29 CFR 2590.716-6(f)(1)(v)(C), and 45 CFR 149.140(f)(1)(v)(C).

2 This is calculated 17,435/ (1 - 0.25) = 23,247.

3 The burden is estimated as follows: 23,247 claims x 2 hours + 23,247 claims x 0.25 hour = 52,305 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 23,247 claims x 2 hours x $105.01 + 23,247 claims x 0.5 hours x $55.23 = $5,203,243. Labor rates are EBSA estimates.

4 The burden is estimated as follows: 17,435 claims x 2 hours + 17,435 claims x 0.25 hours = 39,229 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 17,435 claims x 0.25 hours x $105.01 + 17,435 claims x 2 hours x $55.23 = $3,902,432. Labor rates are EBSA estimates.

5 The burden is estimated as follows: 17,435 claims x 1 percent x 0.5 hours + 17,435 claims x 1 percent x 0.25 hours = 132 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 17,435 claims x 1 percent x 0.5 hours x $105.01 + 17,435 claims x 1 percent x 0.25 hours x $55.23 = $11,538. Labor rates are EBSA estimates.

6 The burden is estimated as follows: (17,435 claims x 25 percent x 1 hour) + (17,435 claims x 25 percent x 0.25 hours) = 5,449 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (17,435 claims x 25 percent x 0.25 hours x $105.01) + (17,435 claims x 25 percent x 1 hour x $55.23) = $517,925. Labor rates are EBSA estimates.

7 The burden is estimated as follows: (17,435 claims x 75 percent x 1 hour) + (17,435 claims x 75 percent x 0.25 hours) = 16,345 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (17,435 claims x 75 percent x 0.25 hours x $105.01) + (17,435 claims x 75 percent x 1 hour x $55.23) = $1,553,658. Labor rates are EBSA estimates.

8 The burden is estimated as follows: (17,435 claims x 2.5 hours + 17,333 claims x 0.5 hours) + (17,435 claims x 2.5 hours + 17,435 claims x 0.5 hours) = 104,610 hours for providers and issuers. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (17,435 claims x 2.5 hours x $105.01 + 17,435 claims x 0.5 hours x $55.23) + (17,435 claims x 2.5 hours x $105.01 + 17,435 claims x 0.5 hours x $55.23) = $10,117,182. Labor rates are EBSA estimates.

9 Employee Benefits Security Administration. “Health Insurance Coverage Bulletin.” (March 2020). https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2020.pdf.

10 Hargraves, John and Aaron Bloschichak. “Air Ambulances-10-Year Trends in Costs and Use.” Health Care Cost Institute. (2019). https://healthcostinstitute.org/emergency-room/air-ambulances-10-year-trends-in-costs-and-use.

11 Government Accountability Office. “Air Ambulance: Available Data Show Privately-Insured Patients are at Financial Risk.” (2019). https://www.gao.gov/assets/gao-19-292.pdf.

12 The Departments estimate that of the 216.2 million individuals with employer-sponsored health insurance, there are 33.2 air transports per 100,000 individuals, of which 69 percent result in an out-of-network bill. The Departments assume that 10 percent of the out-of-network bills will end up in IDR. (216,200,000 x 0.000333 x 0.69 x 0.1= 4,968).

13 This is calculated as 4,968 / (1 - 0.25) = 6,624.

14 The burden is estimated as follows: 6,624 claims x 2 hours + 6,624 claims x 0.25 hours = 14,903 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 6,624 claims x 0.25 hours x $105.01 + 6,624 claims x 2 hours x $55.23 = $1,482,522. Labor rates are EBSA estimates.

15 The burden is estimated as follows: 4,968 claims x 2 hours + 4,968 claims x 0.25 hours = 11,177 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 4,968 claims x 0.25 hours x $105.01 + 4,968 claims x 2 hours x $55.23 = $1,111,892. Labor rates are EBSA estimates.

16 The burden is estimated as follows: 4,968 claims x 1 percent x 0.5 hours + 4,968 claims x 1 percent x 0.25 hours = 38 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 4,968 claims x 1 percent x 0.5 hours x $105.01 + 4,968 claims x 1 percent x 0.25 hours x $55.23 = $3,316. Labor rates are EBSA estimates.

17 The burden is estimated as follows: (4,968 claims x 75 percent x 1 hour) + (4,968 claims x 75 percent x 0.25 hours) = 4,658 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (4,968 claims x 75 percent x 0.25 hours x $105.01) + (4,968 claims x 75 percent x 1 hour x $55.23) = $442,714. Labor rates are EBSA estimates.

18 The burden is estimated as follows: (4,968 claims x 25 percent x 1 hour) + (4,968 claims x 25 percent x 0.25 hours) = 1,553 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (4,968 claims x 25 percent x 0.25 hours x $105.01) + (4,968 claims x 25 percent x 1 hour x $55.23) = $147,571. Labor rates are EBSA estimates.

19 The burden is estimated as follows: (4,968 claims x 2 hours + 4,968 claims x 0.25 hours) + (4,968 claims x 2 hours + 4,968 claims x 0.25 hours) = 22,354 hours for providers and issuers. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (4,968 claims x 2 hours x $105.01 + 4,968 claims x 0.25 hours x $55.23) + (4,968 claims x 2 hours x $105.01 + 4,968 claims x 0.25 hours x $105.01) = $2,223,783. Labor rates are EBSA estimates.

20 The burden is estimated as follows: 100 requests x 0.25 hour = 25 hours. A labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: 100 requests x 0.25 hours x $55.23 = $1,381. Labor rates are EBSA estimates.

21 This is calculated 17,435/ (1 - 0.25) = 23,247.

22 This is calculated 23,247 x 0.05 x ($0.05 + $0.58) = $732.

23 This is calculated 17,435 x 0.05 x ($0.05 + $0.58) = $549.

24 This is calculated 13,076 x 0.05 x ($0.05 + $0.58) = $412.

25 This is calculated 4,359 x 0.05 x ($0.05 + $0.58) = $137.

26 This is calculated (17,435x 0.05 x ($0.05 + $0.58) + (17,435 x 0.05 x ($0.05 + $0.58) = $1,098.

27 IDR Payment Determination Notification (ERISA 716(c)(5)(A))

28 The Department of Labor uses a composite wage rate because different professionals will review different types of claims and groups of individuals. The wage rate of a physician is $172.33 and the wage rate of a medical billing specialist is $105.01. (Internal DOL calculation based on 2020 labor cost data. For a description of the Department’s methodology for calculating wage rates, see https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf.) The composite wage rate is estimated in the following manner: ($172.33 x (1/3) + $105.01 (2/3) = $127.45)

29 17,435 claims x 0.5 hours x $127.45 as the composite wage rate for a physician and medical billing specialist = $1,111,045

30 The burden is estimated as follows: (17,435 claims x 30 minutes) = 8,667 hours for providers and issuers. A labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (17,435 claims x 30 minutes x $55.23) = $481,468 Labor rates are EBSA estimates.

31 This is calculated as 4,968 / (1 - 0.25) = 6,624.

32 This is calculated 6,624 x 0.05 x ($0.05 + $0.58) = $209.

33 This is calculated 4,968 x 0.05 x ($0.05 + $0.58) = $157.

34 This is calculated 3,726 x 0.05 x ($0.05 + $0.58) = $117.

35 This is calculated 1,242 x 0.05 x ($0.05 + $0.58) = $39.

36 This is calculated (4,968 x 0.05 x ($0.05 + $0.58)) + (4,968 x 0.05 x ($0.05 + $0.58)) = $313.

37 IDR Payment Determination Notification (ERISA 716(c)(5)(A)).

38 The Department of Labor uses a composite wage rate because different professionals will review different types of claims and groups of individuals. The wage rate of a physician is $172.33 and the wage rate of a medical billing specialist is $105.01. (Internal DOL calculation based on 2020 labor cost data. For a description of the Department’s methodology for calculating wage rates, see https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf.) The composite wage rate is estimated in the following manner: ($172.33 x (1/3) + $105.01 (2/3) = $127.45)

39 4,968 claims x 0.5 hours x $127.45 as the composite wage rate for a physician and medical billing specialist = $316,586

40 The burden is estimated as follows: (4,968 claims x 30 minutes) = 2,484 hours for providers and issuers. A labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (4,968 claims x 30 minutes x $55.23) = $137,181. Labor rates are EBSA estimates.

41 The burden is estimated as follows: (50 IDR entities x 5.10 hours) + (50 IDR entities x 0.25 hours) = 268 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (50 IDR entities x 5.10 hours x $105.01) + (50 IDR entities x 0.25 hours x $55.23) = $27,468.

42 The burden is estimated as follows: (18 hours x $55.23) = $994.14 each IDR entity. A labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (50 x 18 hours x $55.23) = $49,707. Labor rates are EBSA estimates.

43 The burden is estimated as follows: (50 IDR entities x 1/5 x 2.1 hours) + (50 IDR entities x 1/5 x 0.25 hours) = 24 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (50 IDR entities x 1/5 x 2.1 hours x $105.01) + (50 IDR entities x 1/5 x 0.25 hours x $55.23) = $2,343.

44 The burden is estimated as follows: (3 petitions x 2 hours) + (3 petitions x 0.25 hours) = 6 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (3 petitions x 2 hours x $105.01) + (3 petitions x 0.25 hours x $55.23) = $560.

45 The burden is estimated as follows: (50 IDR entities x 1 hour x 12 reports annually) + (50 IDR entities x 0.25 hours x 12 reports annually) = 750 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (200 IDR entities x 1 hour x 12 reports x $105.01) + (200 IDR entities x 0.25 hours x 12 reports x $55.23) = $71,291.

46 The burden is estimated as follows: (3 certified IDR entities x 1 hour) + (3 certified IDR entities x 0.75 hour) = 5 hours. A labor rate of $105.01 is used for a medical and health services manager and a labor rate of $55.23 is used for a clerical worker. The labor rates are applied in the following calculation: (3 certified IDR entities x 1 hour x $105.01) + (3 certified IDR entities x 0.75 hours x $122.55) = $591.

47 This is calculated 3 x 0.05 x ($0.05 + $0.58) = $0.09

19