The Plan Benefit Package (PBP) and Formulary Submission for Advantage (MA) Plans and Prescription Drug Plans (PDPs) (CMS-R-262)

Forms and Documents

Document Name	Status
Form R-262 CY2019 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262) Form	Modified
CMS-R-262 - Supporting Statement A (NPRM version 2019-6).docx Supporting Statement A	2019-04-24

IC Document Collections

IC ID	Document Title	Status
43667	CY2019 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262) Form	Modified

ICR Details

OMB Control No: 0938-0763	ICR Reference No: 201904-0938-014
Status: Historical Inactive	Previous ICR Reference No: 201901-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: The Plan Benefit Package (PBP) and Formulary Submission for Advantage (MA) Plans and Prescription Drug Plans (PDPs) (CMS-R-262)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 05/06/2019
	Date Received in OIRA: 04/24/2019
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved	04/30/2022
Responses	6,763	0	6,763
Time Burden (Hours)	65,354	0	65,354
Cost Burden (Dollars)	0	0	0

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Abstract: CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 101 Name of Law: Prescription Drug, Improvement, and Modernization Act of2003 (MMA)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT92	Proposed rulemaking	83 FR 62152	11/30/2018

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 62152	11/30/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
CY2019 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262)	R-262, R-262, R-262, R-262, R-262, R-262, R-262, R-262	Plan Deductible LPPO/RPPO Base 1 ,   Medicare Rx General 1 ,   VBID – General ,   MTMP CY2020 Enhancement Mockups ,   Section A-1 ,   #1a Inpatient Hospital-Acute – Base 1 ,   #19 VBID/MA Uniformity Flexibility/SSBCI ,   OON – General – Base 1

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: For the exceptions related to § 423.120(b)(2)(vi)(D), for protected class drugs for which a Part D sponsor chooses to exclude from their formulary due to a price increase beyond a certain threshold, Part D sponsors would be required to submit an additional justification to CMS during the annual formulary submission process. The justification must explain why the Part D sponsor is excluding such drug from their formulary. The burden associated with this exception would consist of the time and effort put forth by Part D sponsors to prepare and submit their formularies to CMS along with the justification. While the annual formulary preparation and submission process and burden are currently approved by OMB without the need for change, we estimate that it would take an average of 10 minutes (0.167 hours) at $117.04/hr for a pharmacist to prepare and submit each justification. Because Part D sponsors already research list prices to inform the existing formulary negotiation process, we only consider the time necessary to prepare and submit the justification to CMS. We estimate that all 218 Part D plan sponsors (32 PDP parent organizations and 186 MA-PD parent organizations, based on plan year 2018 plan participation) would be subject to this requirement. In aggregate, we estimate an annual burden of 36 hours (0.167 hr x 218 sponsors) at a cost of $4,213 (36 hr x $117.04/hr). The proposed rule would make no changes to our currently approved (active) PBP Software Screenshots and Formulary File Record Layouts.

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Annual Cost to Federal Government: $1,207,520

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? Uncollected

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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: 04/24/2019

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