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)

Forms and Documents

Document Name	Status
Form CMS-10780 Information Related to Qualifying Payment Amount to be Shared with Nonparticipating Providers or Nonparticipating Emergency Facilities Form and Instruction	New
Form CMS-10780 Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer – Consumer Burden Form and Instruction	New
Form CMS-10780 Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer - Facilities and Providers Form and Instruction	New
CMS-10880 - Emergency Justification signed.pdf Supplementary Document	2021-08-31
CMS-10780 - Supporting Statement Emergency .docx Supporting Statement A	2021-08-31

IC Document Collections

IC ID	Document Title	Status
249150	Disclosure for Self-Insured Plans Opting-in to State Law Other-Model Notice	New
249149	Information Related to Qualifying Payment Amount to be Shared with Nonparticipating Providers or Nonparticipating Emergency Facilities Form and Instruction	New
249148	Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer – Consumer Burden Form and Instruction	New
249147	Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer - Facilities and Providers Form and Instruction	New
249146	Plan and Issuer Disclosure on Patient Protections Against Balance Billing Other-Model Notice	New
249145	Title: Provider Disclosure on Patient Protections Against Balance Billing – Facility and Provider Agreements Other-Model Notice	New
249129	Provider Disclosure on Patient Protections Against Balance Billing - Facilities and Providers Other-Model Notice	New
249127	Provider Disclosure on Patient Protections Against Balance Billing - States Other-Model Notice	New

ICR Details

OMB Control No:	ICR Reference No: 202108-0938-017
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO -10780
Title: 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)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  Yes
Type of Review Request: Emergency	Approval Requested By: 09/10/2021
Date Submitted to OIRA: 09/09/2021

	Requested	Previously Approved
Expiration Date	6 Months From Approved
Responses	58,676,716	0
Time Burden (Hours)	4,886,380	0
Cost Burden (Dollars)	0	0

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Abstract: On December 27, 2020, the Consolidated Appropriations Act, 2021 (Pub. L. 116-260), which included 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 medical bills arise most frequently. The 2021 interim final regulations “Requirements Related to Surprise Billing; Part I” (2021 interim final regulations) issued by the Departments of Health and Humans 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 (FEHB) 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 are 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.

Emergency Justfication: 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. 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).

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Authorizing Statute(s): PL: Pub.L. 116 - 260 Title I of Division BB Name of Law: Consolidated Appropriations Act, 2021
  

Citations for New Statutory Requirements: PL: Pub.L. 116 - 260 Title I of Division BB Name of Law: Consolidated Appropriations Act, 2021

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU63	Final or interim final rulemaking	86 FR 36872	07/13/2021

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Disclosure for Self-Insured Plans Opting-in to State Law
Information Related to Qualifying Payment Amount to be Shared with Nonparticipating Providers or Nonparticipating Emergency Facilities	CMS-10780	Standard Notice and Consent
Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer - Facilities and Providers	CMS-10780	Standard Notice and Consent
Notice and Consent to be Treated by a Nonparticipating Provider or Nonparticipating Emergency Facility, Retention of Certain Documents, and Notice to Plan or Issuer – Consumer Burden	CMS-10780	Standard Notice and Consent
Plan and Issuer Disclosure on Patient Protections Against Balance Billing
Provider Disclosure on Patient Protections Against Balance Billing - Facilities and Providers
Provider Disclosure on Patient Protections Against Balance Billing - States
Title: Provider Disclosure on Patient Protections Against Balance Billing – Facility and Provider Agreements

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	58,676,716	0	58,676,716	0	0	0
Annual Time Burden (Hours)	4,886,380	0	4,886,380	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  Yes

Description/Changes for Common Form Usage:  The notice and consent documents and disclosures on balance billing protections provided by plans and issuers and nonparticipating providers and facilities will provide information to participants, beneficiaries, or enrollees regarding the protections against surprise medical bills. The requirements related to the notice and consent documents will help ensure that individuals are not pressured to waive their rights and that individuals will only waive their rights if they wish to obtain the services of a nonparticipating provider for a specific reason. Plans and issuers will be provided the information they need in order to determine if balance billing protections apply to specific items and services provided by a nonparticipating provider or nonparticipating emergency facility or if the enrollee provided consent to waive those protections.

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/09/2021

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