Requirements Related to No Surprise Billing Act, Part II (CMS-10791)

Forms and Documents

Document Name	Status
Form CMS-10791 Patient-Provider Selected Dispute Resolution Entity Certification – First-Time/Initial Form and Instruction	New
HHS PRA Supporting Statement 09.28.2021 clean.docx Supporting Statement A	2021-10-05
CMS-10791. Emergency Justification (signed).pdf Supplementary Document	2021-10-05

IC Document Collections

IC ID	Document Title	Status
249569	Notice of Right to Good Faith Estimate – Individual Physician Practitioners Other-Notice	New
249568	Notice of Right to Good Faith Estimate – Wholly Physician-Owned Private Practices Other-Data Elements	New
249567	Requirements for Provisions of Good Faith Estimates of Expected Charges Upon Request of Uninsured Individuals for Scheduled Items and Services Other-Notice	New
249566	Patient-Provider Dispute Resolution Process Other-Data Templates	New
249565	Patient-Provider Selected Dispute Resolution Entity Certification – First-Time/Initial Form and Instruction	New
249564	Health Care Facilities on Behalf of Health Care Providers and Health Care Facilities Other-Notice	New
249552	Patient-Provider Selected Dispute Resolution Entity Recertification Other-Data Elements	New

ICR Details

OMB Control No:	ICR Reference No: 202109-0938-015
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Requirements Related to No Surprise Billing Act, 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: Emergency	Approval Requested By: 10/11/2021
OIRA Conclusion Action: Withdrawn	Conclusion Date: 10/07/2021
	Date Received in OIRA: 10/07/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

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 or 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.

Emergency Justfication: Before January 1, 2022, the HHS needs to certify the independent dispute resolution (IDR) entities, therefore, the regulated community needs to prepare for the January 1, 2022 applicability date. If normal clearance procedures are followed, this statutory deadline may be missed and the IDR process and other regulatory provisions will not be available with its accompany protections.

---

Authorizing Statute(s): PL: Pub.L. 116 - 260 103 Name of Law: Consolidated Appropriations Act - 2021
   PL: Pub.L. 116 - 260 105 Name of Law: Consolidated Appropriations Act - 2021
  

Citations for New Statutory Requirements: PL: Pub.L. 105 - 105 No Surprises Act Name of Law: Consolidated Appropriations Act - 2021

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU62	Final or interim final rulemaking	86 FR 55980	10/07/2021

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Health Care Facilities on Behalf of Health Care Providers and Health Care Facilities	CMS-10791	Good Faith Estimate for Health Care Items and Services
Notice of Right to Good Faith Estimate – Individual Physician Practitioners	CMS-10791	Good Faith Estimate for Health Care Items and Services
Notice of Right to Good Faith Estimate – Wholly Physician-Owned Private Practices
Patient-Provider Dispute Resolution Process
Patient-Provider Selected Dispute Resolution Entity Certification – First-Time/Initial	CMS-10791	Dispute Initiation Form
Patient-Provider Selected Dispute Resolution Entity Recertification
Requirements for Provisions of Good Faith Estimates of Expected Charges Upon Request of Uninsured Individuals for Scheduled Items and Services

---

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.

---

Annual Cost to Federal Government: $12,000,000

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

---

Common Form ICR:  No

---

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: 10/07/2021

---