[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62206-62208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24497]


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DEPARTMENT OF LABOR

Employee Benefits Security Administration


Agency Information Collection Activities; Request for Public 
Comment

AGENCY: Employee Benefits Security Administration (EBSA), Department of 
Labor.

ACTION: Notice.

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SUMMARY: The Department of Labor (the Department), in accordance with 
the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), 
provides the general public and Federal agencies with an opportunity to 
comment on proposed and continuing collections of information. This 
helps the Department assess the impact of its information collection 
requirements and minimize the reporting burden on the public and helps 
the public understand the Department's information collection 
requirements and provide the requested data in the desired format. 
Currently, the Employee Benefits Security Administration (EBSA) is 
soliciting comments on No Surprises Act: IDR Process, Affordable Care 
Act Internal Claims and Appeals and External Review Procedures for 
ERISA Plans, and Opt-in State Balance Bill Process. A copy of the 
information collection request (ICR) may be obtained by contacting the 
office listed in the ADDRESSES section of this notice.

DATES: Written comments must be submitted to the office shown in the 
ADDRESSES section on or before January 10, 2022.

ADDRESSES: James Butikofer, Department of Labor, Employee Benefits 
Security Administration, 200 Constitution Avenue NW, Room N- 5718, 
Washington, DC 20210, or [email protected].

SUPPLEMENTARY INFORMATION:

I. Current Actions

    This notice requests public comment pertaining to the Department's 
request for extension of OMB's approval of the Application. After 
considering comments received in response to this notice, the 
Department intends to submit an ICR to OMB for continuing approval. No 
change to the existing ICR is proposed or made at this time. The 
Department notes that an agency may not conduct or sponsor, and a 
person is not required to respond to, an information collection unless 
it displays a valid OMB control number. A summary of the ICR and the 
current burden estimates follows:
    Agency: Employee Benefits Security Administration, Department of 
Labor.
    Title: No Surprises Act: IDR Process.
    Type of Review: Extension of a currently approved collection of 
information.
    OMB Number: 1210-0169.
    Affected Public: Business or other for-profit; Not-for-profit 
institutions.
    Respondents: 22,257.
    Frequency of Responses: On occasion.
    Responses: 36,675.
    Estimated Total Burden Hours: 65,948.
    Estimated Total Burden Cost (Operating and Maintenance): $187,546.
    Description: 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. In addition, 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 services. More 
specifically, the Federal IDR provisions may be used to determine the 
out-of-network rate for certain emergency services, 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. Finally, 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.
    The Federal IDR process requires a number of disclosures from 
plans, issuers, FEHB carriers, and nonparticipating providers or 
nonparticipating emergency facilities.
    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 initial payment or notice of denial of payment for the 
qualified item or service. 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 of the party sending the open negotiation notice.
    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. 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

[[Page 62207]]

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.
    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. 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 has received 
approval from the Departments to charge a fee outside of the allowed 
range) through a random selection method.
    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 provider or 
facility and the plan or issuer must submit to the certified IDR entity 
an offer for a payment amount for the qualified IDR item or service 
furnished by such provider or facility though the Federal IDR portal. 
After the selected certified IDR entity has reviewed the offer, the 
certified IDR entity must notify the provider or facility and the plan, 
issuer, or FEHB carrier of the payment determination and the reason for 
such determination, in a form and manner specified by the Departments.
    If the certified IDR entity does not choose the offer closest to 
the QPA, the certified IDR entity's written decision must include an 
explanation of the credible information that the certified IDR entity 
determined demonstrated that the QPA was materially different from the 
appropriate out-of-network rate, based on the permitted considerations, 
with respect to the qualified IDR item or service.
    On October 7, 2021, the Office of Management and Budget (OMB) 
approved the information collection request (OMB Control Number 1210-
0169) under the emergency procedures for review and clearance in 
accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 
U.S.C. Chapter 35) and 5 CFR 1320.13. The approval is scheduled to 
expire on April 30, 2022.
    Agency: Employee Benefits Security Administration, Department of 
Labor.
    Title: Affordable Care Act Internal Claims and Appeals and External 
Review Procedures for ERISA Plans.
    Type of Review: Extension of a currently approved collection of 
information.
    OMB Number: 1210-0144.
    Affected Public: Business or other for-profit; Not-for-profit 
institutions.
    Respondents: 2,524,241.
    Frequency of Responses: On occasion.
    Responses: 381,826.
    Estimated Total Burden Hours: 3,241.
    Estimated Total Burden Cost (Operating and Maintenance): 
$1,627,679.
    Description: The Patient Protection and Affordable Care Act, Public 
Law 111-148, (the Affordable Care Act or the Act) was enacted on March 
23, 2010. As part of the Act, Congress added Public Health Service Act 
(the PHS Act) section 2719, which provides rules relating to internal 
claims and appeals and external review processes. The Departments 
issued final regulations (80 FR 72191) that set forth rules 
implementing PHS Act section 2719 for internal claims and appeals and 
external review processes. With respect to internal claims and appeals 
processes for group health coverage, PHS Act section 2719 and paragraph 
(b)(2)(i) of the interim final regulations provide that group health 
plans and health insurance issuers offering group health insurance 
coverage must comply with the internal claims and appeals processes set 
forth in 29 CFR 2560.503-1 (the DOL claims procedure regulation) and 
update such processes in accordance with standards established by the 
Secretary of Labor in paragraph (b)(2)(ii) of the regulations.
    The DOL claims procedure regulation requires plans to provide every 
claimant who is denied a claim with a written or electronic notice that 
contains the specific reasons for denial, a reference to the relevant 
plan provisions on which the denial is based, a description of any 
additional information necessary to perfect the claim, and a 
description of steps to be taken if the participant or beneficiary 
wishes to appeal the denial. The regulation also requires that any 
adverse decision upon review be in writing (including electronic means) 
and include specific reasons for the decision, as well as references to 
relevant plan provisions. Paragraph (b)(2)(ii)(C) of the final 
regulations adds a requirement that non-grandfathered ERISA-covered 
group health plans provide to the claimant, free of charge, any new or 
additional evidence considered relied upon, or generated by the plan or 
issuer in connection with the claim. Also, PHS Act section 2719 and the 
final regulations provide that group health plans and issuers offering 
group health insurance coverage must comply either with a State 
external review process or a Federal review process. The regulations 
provide a basis for determining when plans and issuers must comply with 
an applicable State external review process and when they must comply 
with the Federal external review process.
    The No Surprises Act of 2020 extends the balance billing protection 
related to external reviews to grandfathered plans. The definitions of 
group health plan and health insurance issuer that are cited in section 
110 of the No Surprises Act include both grandfathered and non-
grandfathered plans and coverage. Accordingly, the practical effect of 
section 110 of the No Surprises Act is that grandfathered health plans 
must provide external review for adverse benefit determinations 
involving benefits subject to these surprise billing protections.
    On October 7, 2021, the Office of Management and Budget (OMB) 
approved the information collection request (OMB Control Number 1210-
0144 under the emergency procedures for review and clearance in 
accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 
U.S.C. Chapter 35) and 5 CFR 1320.13. The approval is scheduled to 
expire on April 30, 2022.
    Agency: Employee Benefits Security Administration, Department of 
Labor.
    Title: Opt-in State Balance Bill Process.
    Type of Review: Extension of a currently approved collection of 
information.
    OMB Number: 1210-0168.
    Affected Public: Business or other for-profit; Not-for-profit 
institutions.
    Respondents: 103.
    Frequency of Responses: On occasion.
    Responses: 103.
    Estimated Total Burden Hours: 155.
    Estimated Total Burden Cost (Operating and Maintenance): $54.
    Description: The No Surprises Act was enacted as part of the 
Consolidated Appropriations Act, 2021 (Pub. L. 116-260). The interim 
final rules allow plans to voluntarily opt in to state law that 
provides for a method for determining the cost-sharing amount or total 
amount payable under such a plan, where a state

[[Page 62208]]

has chosen to expand access to such plans, to satisfy their obligations 
under section 9816(a)-(d) of the Code, section 716(a)-(d) of ERISA, and 
section 2799A-1(a)-(d) of the PHS Act. A plan that has chosen to opt 
into a state law must prominently display in its plan materials 
describing the coverage of out-of-network services a statement that the 
plan has opted into a specified state law, identify the state (or 
states), and include a general description of the items and services 
provided by nonparticipating facilities and providers that are covered 
by the specified state law.
    On September 22, 2021, the Office of Management and Budget (OMB) 
approved the information collection request (OMB Control Number 1210-
0168 under the emergency procedures for review and clearance in 
accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 
U.S.C. Chapter 35) and 5 CFR 1320.13. The approval is scheduled to 
expire on March 31, 2022.

II. Focus of Comments

    The Department is particularly interested in comments that:
     Evaluate whether the collections of information are 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
     Evaluate the accuracy of the agency's estimate of the 
collections of information, including the validity of the methodology 
and assumptions used;
     Enhance the quality, utility, and clarity of the 
information to be collected; and
     Minimize the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., by 
permitting electronic submissions of responses.
     Evaluate the effectiveness of the additional demographic 
questions.
    Comments submitted in response to this notice will be summarized 
and/or included in the ICR for OMB approval of the information 
collection; they will also become a matter of public record.
    Comments submitted in response to this notice will be summarized 
and/or included in the ICR for OMB approval of the information 
collection; they will also become a matter of public record.

    Signed at Washington, DC, this 29th day of October, 2021.
Ali Khawar,
Acting Assistant Secretary, Employee Benefits Security Administration, 
U.S. Department of Labor.
[FR Doc. 2021-24497 Filed 11-8-21; 8:45 am]
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