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OMB Control No: 0938-1394	ICR Reference No: 202009-0938-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Pharmacy Benefit Manager Transparency (CMS-10725)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/30/2021
	Date Received in OIRA: 09/15/2020
Terms of Clearance: Approved consistent with the understanding that CMS will add language wherever this data is reported or summarized that clearly caveats the limitations due to changes in the number or characteristics of respondents. CMS will continue to analyze and consider methods of submission that reduce or eliminate manual entry. CMS will consider ways in the future to streamline or align with other related collections.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2024	36 Months From Approved
Responses	355	0	0
Time Burden (Hours)	5,255	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Reconciliation Act of 2010 (P.L.111-152) (collectively, the Patient Protection and Affordable Care Act (PPACA)) were signed into law in 2010. The PPACA established competitive private health insurance markets, called Marketplaces or Exchanges, which give millions of Americans and small businesses access to qualified health plans (QHPs), including stand-alone dental plans (SADPs) — private health and dental insurance plans that are certified as meeting certain standards. The PPACA added section 1150A of the Social Security Act, which requires pharmacy benefit managers (PBMs) to report prescription benefit information to the Department of Health and Human Services (HHS). PBMs are third-party administrators of prescription programs for a variety of types of health plans, including QHPs. The Centers for Medicare and Medicaid Services (CMS) files this information collection request (ICR) in connection with the prescription benefit information that PBMs must provide to HHS under section 1150A. The burden estimate for this ICR reflects 1) the time and effort for PBMs to submit the information regarding PBMs and prescription drugs, and 2) the time and effort for QHP issuers to identify which plans are QHPs for the PBMs.

Authorizing Statute(s): None

Citations for New Statutory Requirements: PL: Pub.L. 111 - 152 1553 Name of Law: Health Care and Education Reconciliation Act of 2010
US Code: 42 USC 1320b–23 Name of Law: Social Security Act
PL: Pub.L. 111 - 148 1526 Name of Law: Patient Protection and Affordable Care Act

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

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 4993	01/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 56227	09/11/2020
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Identification of QHPs
One-Time Technical Build
PBM - Annual Submission of Prescription Benefit Information	CMS-10725, CMS-10725, CMs-10725, CMS-10725	, , ,

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	355	355
Annual Time Burden (Hours)	5,255	5,255
Annual Cost Burden (Dollars)	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: There are no changes to the burden as this is a new data collection.

Annual Cost to Federal Government: $167,494

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

Agency Contact: Jamaa Hill 301 492-4190

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