Emergency Justification

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

OFFICE OF THE ADMINISTRATOR

DATE:

October 5, 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
Information Collection Requirements Related to Surprise Billing; Part II; (CMS9908-IFC), OMB 0938-AU62

Emergency Justification
The Department of Labor (DOL), Department of Health and Human Services (HHS), and the
Department of the Treasury (the Departments) and the Office of Personnel Management (OPM),
seek an emergency review and approval of the Paperwork Reduction Act (PRA) requirements
related to the information collection requests (ICR) regarding implementation of the No
Surprises Act (NSA). As explained in more detail below, we believe this process is warranted for
a variety of reasons under 5 CFR 1320.13(a).
The NSA was enacted on December 27, 2020, as title I of Division BB of the Consolidated
Appropriations Act, 2021.1 The independent dispute resolution (IDR) provisions and protections
for the uninsured in the NSA apply for plan years (in the individual market, policy years)
beginning on or after January 1, 2022. The use of the normal PRA procedures is likely to prevent
the Departments from collecting information that will be essential to meeting the effective dates
of the NSA. For example, in order to meet the statutory requirements, the Departments need to
begin collecting eligibility data from potential IDR or selected dispute resolution (SDR) entities
for certification including level of expertise and staffing, conflicts of interest disclosures,
accreditation, confidentiality practices, list of fees, appropriate fiscal integrity indicators, among
other information. The Departments need to collect this information and begin certifying IDR
and SDR entities in fall of 2021 in order to establish the necessary IDR and SDR entities and
related contracts, and implement the federal IDR process by January 1, 2022.

1

Text - H.R.133 - 116th Congress (2019-2020): Consolidated Appropriations Act, 2021 | Congress.gov | Library of
Congress

Additionally, the information collection in this PRA submission is in the interim final rule,
“Requirements Related to Surprise Billing; Part II.” The Departments waived proposed
rulemaking for that rule, including the ICRs, because it is in the public interest to promulgate
interim final rules and it would be impracticable and contrary to the public interest to engage in
full notice and comment rulemaking before the interim final rules become effective. The same
justification for waiving proposed rulemaking applies to emergency review and approval of the
PRA submission. Emergency approval of the PRA package ICRs is a vital step in implementing
the consumer protections intended by passage of the NSA.
Background
The provisions under Code sections 9816(c) and 9817(b), ERISA sections 716(c) and 717(b),
and PHS Act sections 2799A-1(c) and 2799A-2(b), as added by sections 103 and 105 of the
NSA, establish a federal IDR process that nonparticipating providers or facilities,
nonparticipating providers of air ambulance services, 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. The federal IDR process 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, as well as for air ambulance services furnished
by nonparticipating providers of air ambulance services.
Under the NSA, upon receiving an initial payment or notice of denial of payment from a plan or
issuer, the health care provider or plan or issuer may initiate an open negotiation period. If the
parties cannot agree on an out-of-network rate, either party may initiate the federal IDR process
and may jointly select a certified IDR entity, or, if the parties do not select a certified IDR entity,
the Departments will do so. The NSA specifies that the certified IDR entity selected cannot be a
party to the determination or their employee or agent, have a material familial, financial, or
professional relationship with such party, or otherwise have a conflict of interest.
In resolving the disputes through the federal IDR process, the NSA provides that each party must
submit to the certified IDR entity an offer for a payment amount for the item or service in dispute
and other information as requested by the certified IDR entity. The IDRE must determine the
amount of payment under the plan or coverage for such item or service as furnished by such
provider or facility, in accordance with factors set out by the NSA and subsequent regulations.
The NSA also sets out requirements for certification of IDR entities by the Departments. To be
certified, IDR entities must provide written documentation demonstrating that they meet the
eligibility criteria. The interim final rules require certified IDR entities submit information
related to the federal IDR process, in order to allow the Departments to quarterly publish
information on IDR determinations.
Additionally, the NSA includes provisions that require health care providers and health care
facilities to furnish good faith estimates upon request or upon scheduling items or services to
uninsured (or self-pay) individuals. In order to implement these good faith estimate provisions
under PHS Act section 2799B-6(1) and 2799B-6(2)(B), as added by section 112 of the NSA,
HHS is adding 45 CFR 149.610 to establish requirements for providers and facilities to

specifically inquire about an individual’s health coverage status, notify individuals of the ability
to receive a good faith estimate and establish requirements for providing a good faith estimate.
PHS Act section 2799B-6(2) and these interim final rules specify that a provider or facility must
provide a notification (in clear and understandable language) of the good faith estimate of the
expected charges for furnishing such items or services (including any items or services that are
reasonably expected to be provided in conjunction with such scheduled items or services and
such items or services reasonably expected to be so provided by another health care provider or
health care facility), with the expected billing and diagnostic codes (i.e., ICD, CPT, HCPCS,
and/or DRG codes) for any such items or services. The definitions related to good faith
estimates of expected charges for uninsured (or self-pay) individuals for scheduled items and
services and upon request, requirements for the providers and facilities, timing, and good faith
estimate content requirements are set forth in PHS Act section 2799B-6 and implementing
regulation at 45 CFR 149.610, established under these interim final rules.
PHS Act section 2799B-7, as added by section 112 of the NSA, provides further protections for
uninsured (or self-pay) individuals by requiring the Secretary of HHS to establish a process (in
this section referred to as patient-provider dispute resolution) under which an uninsured (or selfpay) individual who received from a provider or facility, a good faith estimate of the expected
charges, and who, after being furnished the item or service, is billed for charges that are
substantially in excess of the estimate, may seek a determination from a SDR entity of the
amount of charges to be paid. HHS is adding new 45 CFR 149.611 to implement this patientprovider dispute resolution process including specific definitions related to the patient-provider
dispute resolution process. HHS is also codifying provisions related to: eligibility for the federal
patient-provider dispute resolution process; selection of a SDR entity; fees associated with this
section; certification of SDR entities; and deferral to state patient-provider dispute resolution
processes.
The PRA submission focuses on ICRs related to the Departments requirements under the
September 2021 interim final rules. Based on the legislative and regulatory authority outlined
above, the ICRs advance the legislative goals of the NSA. Emergency approval of the PRA
submission will enable the Departments to implement, without delay, a federal IDR process for
providers (including air-ambulance providers), a federal patient-provider dispute resolution
process, and requirements for a good faith estimate.
We intend to publish the interim final regulation on September 30, 2021. This Emergency
processing request under the PRA is being requested on the same basis that good cause was
found by the Departments and the OPM Director to issue these interim final rules. The
Departments and OPM have determined that it would be impracticable and contrary to the public
interest to delay putting the provisions in these interim final rules in place until after a full public
notice and comment process has been completed. Although this effective date may have allowed
for the regulations, if promulgated with the full notice and comment rulemaking process, to be
applicable in time for the applicability date of the provisions in the NSA, this timeframe would
not provide sufficient time for the regulated entities to implement the requirements. We do not
anticipate significant concerns from the vast majority of stakeholders as the public will welcome
the consumer protections established through the implementation of these provisions. The

interim final rules establish a federal independent dispute resolution process for health plans,
providers, and facilities in addition to a patient-provider dispute resolution process for uninsured
(or self-pay) individuals. The NSA requires that these dispute resolution processes are effective
on the same day as the NSA provisions implemented in the interim final rule with request for
comments, “Requirements Related to Surprise Billing; Part I”. While health care providers,
facilities, and plan issuers may react negatively to some of the additional requirements, there is
general support for the provisions and implementation of the NSA.