Emergency Justification

CMS-10880 - Emergency Justification signed.pdf

Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice and Consent, Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in (CMS-10780)

Emergency Justification

OMB: 0938-1401

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

OFFICE OF THE ADMINISTRATOR

DATE:

August 31, 2021

TO:

Sharon Block
Acting Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget

FROM:

Chiquita Brooks-LaSure
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services

SUBJECT:

Request for Emergency Clearance of the Paperwork Reduction Act Package for
Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice
and Consent, Disclosure on Patient Protections Against Balance Billing, and State
Law Opt-in

Emergency Justification
The Centers for Medicare & Medicaid Services (CMS) is requesting that an information
collection request for some provisions in the Consolidated Appropriations Act of 2021
(Appropriations Act) enacted on December 27, 2020, related to the No Surprises Act be
processed in accordance with the implementing regulations of the Paperwork Reduction Act of
1995 (PRA) at 5 CFR 1320.13(a)(2)(i). We believe that public harm will result if the standard,
non-emergency clearance procedures are followed. CMS is also requesting waiver of the notice
requirement set forth in 5 CFR 1320.13(d).
Specifically, we are requesting emergency approval for the following information collection
requirements (ICRs): (i) information to be shared about the qualifying payment amount (45 CFR
149.140(d)); (ii) audits of the qualifying payment amount (45 CFR 149.140(f)); (iii) disclosure
for self-insured plans opting in to state law (45 CFR 149.30); (iv) notice and consent to waive
balance billing protections, retention of certain documents, and notice to plan or issuer (45 CFR
149.410(b)-(e), 45 CFR 149.420(c) - (i)); (v) provider disclosure on patient protections against
balance billing (45 CFR 149.430); and (vi) plan and issuer disclosure on patient protections
against balance billing (section 2799A-5(c) of the Public Health Service Act).
The cost-sharing and balance billing requirements on plans, issuers, health care providers,
facilities, and providers of air ambulance services in the No Surprises Act apply for plan years
(in the individual market, policy years) beginning on or after January 1, 2022. These ICRs
contain critical protections for participants, beneficiaries, and enrollees against balance billing. It

is in the public interest that individuals receive the protections under the No Surprises Act on the
date on which those protections go into effect. Following the standard PRA process will not
provide plans, health insurance issuers, facilities, health care providers, and providers of air
ambulance services sufficient time to implement these new requirements.
Background
The No Surprises Act provides federal protections against surprise billing and limits out-ofnetwork cost sharing under many of the circumstances in which surprise medical bills arise most
frequently. The 2021 interim final regulations “Requirements Related to Surprise Billing; Part I”
(86 FR 36872, 2021 interim final regulations) issued by the Departments of Health and Human
Services, the Department of Labor, the Department of Treasury, and the Office of Personnel
Management, implement provisions of the No Surprises Act that apply to group health plans,
health insurance issuers offering group or individual health insurance coverage, and carriers in
the Federal Employees Health Benefits Program that provide protections against balance billing
and out-of-network cost sharing with respect to emergency services, non-emergency services
furnished by nonparticipating providers at certain participating health care facilities, and air
ambulance services furnished by nonparticipating providers of air ambulance services. The 2021
interim final regulations prohibit nonparticipating providers, emergency facilities, and providers
of air ambulance services from balance billing participants, beneficiaries, and enrollees in certain
situations unless they satisfy certain notice and consent requirements. The No Surprises Act and
the 2021 interim final regulations require group health plans and issuers of health insurance
coverage to provide information about qualifying payment amounts to nonparticipating providers
and facilities and to provide disclosures on patient protections against balance billing to
participants, beneficiaries and enrollees. Self-insured plans opting in to state law are required to
provide a disclosure to participants. Certain nonparticipating providers and nonparticipating
emergency facilities may provide participants, beneficiaries, and enrollees with notice and obtain
their consent to waive balance billing protections, provided certain requirements are met. In
addition, certain providers and facilities are required to provide disclosures on patient protections
against balance billing to participants, beneficiaries and enrollees.


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File TitleCMS-Letterhead-Template-Color
AuthorCMS
File Modified2021-08-31
File Created2021-08-31

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