Pharmacy Benefit Manager Transparency (CMS-10725)

Forms and Documents

Document Name	Status
Form CMS-10725 PBM - Annual Submission of Prescription Benefit Information Form and Instruction	New
CMS-10725 - Supporting Statement 30-dayx.docx Supporting Statement A	2020-09-14
CMS-10725 - Attachment 3 Crosswalk.pdf Supplementary Document	2020-09-14
CMS-10725 - Attachment 2 External Response to Public Comments_8-10-2020.pdf Supplementary Document	2020-09-14

IC Document Collections

IC ID	Document Title	Status
243638	Identification of QHPs	New
243637	PBM - Annual Submission of Prescription Benefit Information Form and Instruction	New
243636	One-Time Technical Build	New

ICR Details

OMB Control No:	ICR Reference No: 202009-0938-009
Status: Received in OIRA	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	Date Submitted to OIRA: 09/15/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	355	0
Time Burden (Hours)	5,255	0
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 1526 Name of Law: Patient Protection and Affordable Care Act
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

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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:
	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

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

IC Title	Form No.	Form Name
One-Time Technical Build
PBM - Annual Submission of Prescription Benefit Information	CMS-10725, CMS-10725, CMs-10725, CMS-10725	Transparency Attestation ,   Transparency Summary Web Form ,   Transparency Detailed Template ,   QHP Issuer Transparency Attestation
Identification of QHPs

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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	355	0	355	0	0	0
Annual Time Burden (Hours)	5,255	0	5,255	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: There are no changes to the burden as this is a new data collection.

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Annual Cost to Federal Government: $17,494

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

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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: 09/15/2020

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