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

Forms and Documents

Document Name	Status
Form CMS-10141 Business Continuity Plans under 422.504(o) and 423.505(p) Form	Modified
Form CMS-10141 Medicare Prescription Drug Benefit Program (Plans) Form and Instruction	Modified
CMS-10141 - Supporting Statement A (CMS-4180-F version 5).docx Supporting Statement A	2020-03-04
4180-F Comment Responses.docx Supplementary Document	2019-07-09

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)) Other-Part C and D Sample Precluded Provider Letter	Modified
231340	Creation of Model Notices (Plans) (section 423.120(c)(6)) Instruction	Modified
231339	System Programming (Plans) (section 423.120(c)(6))	Modified
217122	Business Continuity Plans under 422.504(o) and 423.505(p) Form	Modified
209891	State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))	Modified
187164	Medicare Prescription Drug Benefit Program (Plans) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 201906-0938-001
Status: Active	Previous ICR Reference No: 201803-0938-004
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/05/2020
	Date Received in OIRA: 07/09/2019
Terms of Clearance: With the next revision, we expect CMS to provide a more complete discussion about how the required 3rd party disclosures covered by this ICR will be used by their intended audience. We also expect CMS to provide a more complete discussion about its required use of paper or interest for the ICs covered by this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved	11/30/2021
Responses	625,627,848	0	54,426,919
Time Burden (Hours)	8,683,706	0	8,667,195
Cost Burden (Dollars)	5,733,706	0	0

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

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-AT92	Final or interim final rulemaking	84 FR 23832	05/23/2019

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 62152	11/30/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 23832	05/23/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Business Continuity Plans under 422.504(o) and 423.505(p)	CMS-10141, CMS-10141, CMS-10141, CMS-10141	Compensation Certifications ,   Structure Submission Forms ,   Covered Agent Information Sheet ,   Compensation Structure for Writing Agents by Contract/PBP Number
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	Model Part D Explanation of Benefits ,   Exhibit A: Example Cover Page of the Model Part D EOB ,   Exhibit B: Examples of Section 1 (the List of Prescriptions) ,   Exhibit C: Example of Section 2 (Drug Payment Stages) ,   Exhibit D: Example of Section 3 (Amounts and Definitions for TrOOP and Total Drug Costs) ,   Exhibit E: Example of Section 4 (Changes to the Formulary) ,   Exhibit F: Example of Sections 5 and 6 (Information for Reference) ,   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))
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
Preparation and Issuance of Model Notices (section 423.120(c)(6))

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ICR Summary of Burden

	Total Approved	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	625,627,848	54,426,919	0	571,200,929	0	0
Annual Time Burden (Hours)	8,683,706	8,667,195	0	16,511	0	0
Annual Cost Burden (Dollars)	5,733,706	0	0	5,733,706	0	0

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: In association with RIN 0938-AT92 (CMS-4180-F) which published in the Federal Register on May 23, 2019 (84 FR 23832): Our currently approved burden estimate sets out 8,667,195 total hours. We are revising this figure to include the burden set forth with the addition of the EOB provisions §423.128 and the Part B Step Therapy provision for an additional 16,367 hours or a total of 8,683,562 hours (8,667,195 hr + 16,367 hr) Our currently approved burden estimate also sets out 54,426,919 total responses. We are revising this figure to include the burden set forth with the addition of the EOB provisions §423.128 and the Part B Step Therapy provision for an additional 571,200,929 responses or a total of 625,627,848 responses (54,426,919 + 571,200,929).

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Annual Cost to Federal Government: $744

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? 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: 07/09/2019

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