Prescription Drug and Health Care Spending (CMS-10788)

Forms and Documents

Document Name	Status
CMS-10788 Prescription Drug and Health Care Spending Supporting Statement - Emergency.docx Supporting Statement A	2021-11-23

IC Document Collections

IC ID	Document Title	Status
250526	PBMs Instruction	New
250524	TPAs Instruction	New
250521	Issuers and FEHB Carriers Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202111-0938-012
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Prescription Drug and Health Care Spending (CMS-10788)
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: 12/23/2021
Date Submitted to OIRA: 11/23/2021

	Requested	Previously Approved
Expiration Date	6 Months From Approved
Responses	356	0
Time Burden (Hours)	1,684,080	0
Cost Burden (Dollars)	0	0

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Abstract: On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed into law. Section 204 of Title II of Division BB of the CAA added parallel provisions at section 9825 of the Internal Revenue Code (the Code), section 725 of the Employee Retirement Income Security Act (ERISA), and section 2799A-10 of the Public Health Service Act (PHS Act) that require group health plans and health insurance issuers offering group or individual health insurance coverage to annually report to the Department of Treasury, the Department of Labor (DOL), and the Department of Health and Human Services (HHS) (collectively, “the Departments”) certain information about prescription drug and health care spending, premiums, and enrollment under the plan or coverage. This information will support the development of public reports that will be published by the Departments on prescription drug reimbursements for plans and coverage, prescription drug pricing trends, and the role of prescription drug costs in contributing to premium increases or decreases under the plans or coverage. The 2021 interim final rules, “Prescription Drug and Health Care Spending” (2021 interim final rules), issued by the Departments and the Office of Personnel Management (OPM) implement the provisions of section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act, as enacted by section 204 of Title II of Division BB of the CAA. OPM joined the Departments in issuing the 2021 interim final rules, requiring Federal Employees Health Benefits (FEHB) carriers to report information about prescription drug and health care spending, premiums, and plan enrollment in the same manner as a group health plan or health insurance issuer offering group or individual health insurance coverage.

Emergency Justfication: See attached.

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Authorizing Statute(s): PL: Pub.L. 116 - 260 204 Name of Law: Consolidated Appropriations Act, 2021
   PL: Pub.L. 93 - 406 725 Name of Law: ERISA
  

Citations for New Statutory Requirements: PL: Pub.L. 93 - 406 725 Name of Law: ERISA
PL: Pub.L. 116 - 260 204 Name of Law: Consolidated Appropriations Act, 2021

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU66	Final or interim final rulemaking	86 FR 66662	11/23/2021

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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: 3

IC Title	Form No.	Form Name
Issuers and FEHB Carriers
PBMs
TPAs

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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	356	0	356	0	0	0
Annual Time Burden (Hours)	1,684,080	0	1,684,080	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: $4,700,000

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: 11/23/2021

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