Comprehensive Addiction and Recovery Act of 2016 (CARA) / Medicare Prescription Drug Benefit Program (CMS-10141)

Forms and Documents

Document Name	Status
Form CMS-10410 Preparation and Issuance of Model Notices (section 423.120(c)(6)) Form and Instruction	Modified
CMS-10141 - Supporting Statement A (CMS-4190-F1 and F2 version 7).docx Supporting Statement A	2021-11-09
60 Day Comments and Responses.docx Supplementary Document	2021-11-09
Attachment 3. Crosswalk CY 2022 EOB.pdf Supplementary Document	2021-11-09
Attachment 2. Crosswalk for Model Precluded Provider Letter.pdf Supplementary Document	2021-11-09
Attachment 1f. 60-Day Crosswalk for Model Sponsor Information Transfer Memo.pdf Supplementary Document	2021-11-09
Attachment 1e. 60-Day Crosswalk for Model Prescriber Inquiry Letter.pdf Supplementary Document	2021-11-09
Attachment 1d. Crosswalk for Alternate Second Drug Management Program Notice.pdf Supplementary Document	2021-11-09
Attachment 1c. Crosswalk for Second Drug Management Program Notice.pdf Supplementary Document	2021-11-09
Attachment 1b. Crosswalk for Initial Drug Management Program Notice.pdf Supplementary Document	2021-11-09
Attachment 1a. Crosswalk for Instructions for Drug Management Program Notices.pdf Supplementary Document	2021-11-09

IC Document Collections

IC ID	Document Title	Status
8823	Medicare Prescription Drug Benefit Program (Benes)	Modified
231341	Preparation and Issuance of Model Notices (section 423.120(c)(6)) Form and Instruction	Modified
231340	Creation of Model Notices (Plans) (section 423.120(c)(6)) Instruction	Removed
231339	System Programming (Plans) (section 423.120(c)(6))	Removed
217122	Business Continuity Plans under 422.504(o) and 423.505(p)	Modified
209891	State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))	Unchanged
187164	Medicare Prescription Drug Benefit Program (Plans) Instruction	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 202110-0938-012
Status: Received in OIRA	Previous ICR Reference No: 201906-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Comprehensive Addiction and Recovery Act of 2016 (CARA) / Medicare Prescription Drug Benefit Program (CMS-10141)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/09/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2021
Responses	666,813,366	625,627,848
Time Burden (Hours)	6,973,844	8,683,706
Cost Burden (Dollars)	6,252,673	5,733,706

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Abstract: Part D plans and, to the extent applicable, MA organizations will use the information discussed below to comply with the eligibility and other requirements associated with their participation in Part D. CMS will use this information from plan sponsors and States to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. The new information collection will allow CMS to ensure sponsors have plans in place to restore business operations following a disruption of regular operations. Medicare beneficiaries will use the information provided by the Part D sponsors to make decisions regarding Part D enrollment as well as grievance and appeal requests. Under CMS-4182-P (RIN 0938-AT08), CMS will make the Preclusion List available to Part D sponsors. The Part D sponsors will perform system programming to maintain the Preclusion List in order to reject a pharmacy claim (or deny a beneficiary request for reimbursement) for a Part D drug that is prescribed by an individual on the Preclusion List. CMS will create and disseminate model notices to the prescribers to notify them of their existence on the Preclusion List, while the Part D sponsors will create and disseminate model notices to the Medicare beneficiaries to notify them that the pharmacy claim is being rejected or denied due to the prescriber’s existence on the Preclusion List.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
   Statute at Large: 18 Stat. 1860
  

Citations for New Statutory Requirements: PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT97	Final or interim final rulemaking	86 FR 5864	01/19/2021

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 38485	07/21/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 59165	10/26/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Preparation and Issuance of Model Notices (section 423.120(c)(6))	CMS-10410	Model Precluded Provider Letter
Business Continuity Plans under 422.504(o) and 423.505(p)
Creation of Model Notices (Plans) (section 423.120(c)(6))	CMS-10141, CMS-10141, CMS-10141	Initial Notice Sent to Potentially At-Risk Beneficiaries ,   Second Notice Sent to Beneficiary Designating At-Risk Status ,   Alternate Second Notice Sent to Beneficiary Not Considered At-Risk
Medicare Prescription Drug Benefit Program (Benes)
Medicare Prescription Drug Benefit Program (Plans)	CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141, CMS-10141	Initial Notice Sent to Potentially At-Risk Beneficiaries ,   Second Notice Sent to Beneficiary Designating At-Risk Status ,   Alternate Second Notice Sent to Beneficiary Not Considered At-Risk ,   Model Prescriber Inquiry Letter ,   Model Sponsor Information Transfer Memo ,   3a - 2022 Model Part D Explanation of Benefits (All Sections Included) ,   3b - Exhibit A: Example Cover Page of the Model Part D EOB ,   3c - Exhibit B: Examples of Section 1 (the List of Prescriptions) ,   3d - Exhibit C: Example of Section 2 (Drug Payment Stages) ,   3e - Exhibit D: Example of Section 3 (Amounts and Definitions for TrOOP and Total Drug Costs) ,   3f - Exhibit E: Example of Section 4 (Changes to the Formulary) ,   3g - Exhibit F: Example of Sections 5 and 6 (Information for Reference) ,   3h - Exhibit G: Example of a Part D EOB (All Sections Included)
State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))
System Programming (Plans) (section 423.120(c)(6))

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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	666,813,366	625,627,848	0	-4,648,787	45,834,305	0
Annual Time Burden (Hours)	6,973,844	8,683,706	0	-1,761,858	51,996	0
Annual Cost Burden (Dollars)	6,252,673	5,733,706	0	518,967	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The current burden sets out 625,627,848 responses and 8,683,706 hours. We are revising this estimate to 666,813,366 responses and 6,973,844 hours (see Table 15). Total responses increased by 41,185,518 annually, however the annual burden hours decreased by 1,709,862 hours. The net change in burden reflects the addition and removal of ICRs as well as changes in burden associated with existing ICRs updated to reflect the current numbers of Part D contracts. There was a net increase of 32,697,465 responses as a result of the addition and removal of ICRs from this package. The additional 8,488,053 responses (41,185,518 minus 32,697,465) is due to the increased number of Part D contracts in 2021 compared with the number of contracts in the previously approved supporting statement (942 vs 757, respectively). Similarly, because of the increased number of contracts, there was an additional 47,853 hours (1,757,715 minus 1,709,862) of burden which offsets the net of additional and removed ICRs.

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Annual Cost to Federal Government: $778

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]? No

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: 11/09/2021

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