Requirements Related to Surprise Billing; Part II (CMS-10791)

Forms and Documents

Document Name	Status
Form CMS-10791 Good Faith Estimates of Expected Charges Upon Request of Uninsured Individuals for Scheduled Items and Services Form and Instruction	New
Form CMS-10791 Notice of Right to Good Faith Estimate – Individual Physician Practitioners Form and Instruction	New
Form CMS-10791 Notice of Right to Good Faith Estimate – Health Care Facilities Form and Instruction	New
15. 60-day Notice Comments Response Summary_04.15.22_clean.pdf Supplementary Document	2022-04-28
Supporting Statement_clean.docx Supporting Statement A	2022-04-28

IC Document Collections

IC ID	Document Title	Status
253135	Patient-Provider Selected Dispute Resolution Entity Recertification	New
253134	Good Faith Estimates of Expected Charges Upon Request of Uninsured Individuals for Scheduled Items and Services Form and Instruction	New
253132	Notice of Right to Good Faith Estimate – Wholly Physician-Owned Private Practices Instruction	New
253130	Notice of Right to Good Faith Estimate – Individual Physician Practitioners Form and Instruction	New
253129	Notice of Right to Good Faith Estimate – Health Care Facilities Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202204-0938-013
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO - 10791
Title: Requirements Related to Surprise Billing; Part II (CMS-10791)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/29/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	4,010,691	0
Time Burden (Hours)	6,242,228	0
Cost Burden (Dollars)	676,943,115	0

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Abstract: The No Surprises Act adds a new Part E of title XXVII of the PHS Act establishing requirements applicable to health care providers, and facilities. Specifically, the No Surprises Act adds provisions at new PHS Act sections 2799B-6 and 2799B-7, which require providers and facilities to provide a good faith estimate of the total expected charges to uninsured individuals, under certain circumstances, upon their request, for scheduled items and services, and allow uninsured individuals to avail themselves to a patient-provider dispute resolution process if their billed charges after receiving such items or services is substantially in excess of the expected charges listed in the good faith estimate furnished by the provider ot facility. PHS Act section 2799B-6 (2)(A) requires a health care provider or facility to provide a notification of the good faith estimate of expected charges to a plan or issuer in the case the individual is enrolled in such a plan or coverage and is seeking to have a claim for such item or services submitted to such plan or coverage. The good faith estimate of expected charges from the health care provider or facility will inform the advanced explanation of benefits that must be provided by the plan or issuer, as required by PHS Act section 2799A-1(f), in the case the individual is enrolled in such a plan or coverage and is seeking to have a claim for such item or services submitted to such plan or coverage.

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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: US Code: 45 USC 149.610 Name of Law: Requirements for provision of good faith estimates of expected charges for uninsured (or self-pay) i

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 461	01/05/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 25273	04/28/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Good Faith Estimates of Expected Charges Upon Request of Uninsured Individuals for Scheduled Items and Services	CMS-10791	Right to Receive a Good Faith Estimate of Expected Charges Notice
Notice of Right to Good Faith Estimate – Health Care Facilities	CMS-10791	Good Faith Estimates Template and Instructions
Notice of Right to Good Faith Estimate – Individual Physician Practitioners	CMS-10791	Right to Receive a Good Faith Estimate of Expected Charges Notice
Notice of Right to Good Faith Estimate – Wholly Physician-Owned Private Practices
Patient-Provider Selected Dispute Resolution Entity Recertification

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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	4,010,691	0	4,010,691	0	0	0
Annual Time Burden (Hours)	6,242,228	0	6,242,228	0	0	0
Annual Cost Burden (Dollars)	676,943,115	0	676,943,115	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 request for an OMB control number.

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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:  No

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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: 04/29/2022

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