Patient Access Through Application Programming Interfaces (API) (CMS-10767)

Forms and Documents

Document Name	Status
CMS-10767. Justfication of Non-Sub Change Request.docx Justification for No Material/Nonsubstantive Change	2022-10-18
CMS-10767.Supporting_Statement_Appendix (Response to comments).docx Supplementary Document	2020-12-02
CMS-10767.Supporting Statement Part A (10-5-22).docx Supporting Statement A	2022-10-18

IC Document Collections

IC ID	Document Title	Status
244741	On-going Burden	Unchanged
244740	One-Time Burden	Unchanged

ICR Details

OMB Control No: 0938-1412	ICR Reference No: 202210-0938-006
Status: Received in OIRA	Previous ICR Reference No: 202012-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: OBRHI
Title: Patient Access Through Application Programming Interfaces (API) (CMS-10767)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/18/2022

	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023
Responses	690	690
Time Burden (Hours)	6,385,950	6,385,950
Cost Burden (Dollars)	0	0

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Abstract: This final rule is the first phase of policies centrally focused on advancing interoperability and patient access to health information using the authority available to the Centers for Medicare & Medicaid Services (CMS). We believe this is an important step in advancing interoperability, putting patients at the center of their health care, and ensuring they have electronic access to their health information. We are committed to working with stakeholders to solve the issue of interoperability and getting patients access to information about their health care, and we are taking an active approach to move participants in the health care market toward interoperability and the secure and timely exchange of electronic health information by adopting policies for the Medicare and Medicaid programs, the Children’s Health Insurance Program (CHIP), and qualified health plan (QHP) issuers on the individual market Federally-facilitated Exchanges (FFEs). For purposes of this rule, references to QHP issuers on the FFEs excludes issuers offering only stand-alone dental plans (SADPs). Likewise, we are also excluding QHP issuers only offering QHPs in the Federally-facilitated Small Business Health Options Program Exchanges (FF-SHOPs) from the provisions of this rule. This rule requires these impacted payers to maintain and use standards-based APIs to make certain information available to enrollees.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 1311(e) Name of Law: PPACA
   PL: Pub.L. 144 - 255 4003 Name of Law: 21st Century Cures Act
   EO: EO 13813 Name/Subject of EO: Promoting Healthcare Choice and Competition
  

Citations for New Statutory Requirements: PL: Pub.L. 144 - 255 4003 Name of Law: 21st Century Cures Act
PL: Pub.L. 111 - 148 1311(e) Name of Law: PPACA
EO: EO 13813 Name/Subject of EO: Promoting Healthcare Choice and Competition

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT79	Final or interim final rulemaking	85 FR 25510	05/01/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 7610	03/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 25510	05/01/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
On-going Burden
One-Time Burden

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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	690	690	0	0	0	0
Annual Time Burden (Hours)	6,385,950	6,385,950	0	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 information collection request.

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Annual Cost to Federal Government: $130,400,000

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

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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: 10/18/2022

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