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

Forms and Documents

Document Name	Status
Form CMS-10141 Medicare Prescription Drug Benefit Program (PLAN) Form	Modified
Crosswalk for Attachments 1 - 5.xlsx Supplementary Document	2017-12-22
CMS-10141 - Supporting Statement A [rev 12-19-2017 by OSORA PRA].docx Supporting Statement A	2017-12-22

IC Document Collections

IC ID	Document Title	Status
8823	Medicare Prescription Drug Benefit Program (Benes)	Modified
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))	Modified
187164	Medicare Prescription Drug Benefit Program (PLAN) Form	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 201712-0938-003
Status: Historical Inactive	Previous ICR Reference No: 201506-0938-007
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: Comment filed on proposed rule and continue	Conclusion Date: 01/29/2018
	Date Received in OIRA: 12/26/2017
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2018	36 Months From Approved	11/30/2018
Responses	46,099,944	0	46,099,944
Time Burden (Hours)	7,588,143	0	7,588,143
Cost Burden (Dollars)	0	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-AT08	Proposed rulemaking	82 FR 56336	11/28/2017

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 56336	11/28/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Business Continuity Plans under 422.504(o) and 423.505(p)
Medicare Prescription Drug Benefit Program (Benes)
Medicare Prescription Drug Benefit Program (PLAN)	CMS-10141, CMS-10141, CMS-10141, CMS-10141	Compensation Certification ,   Description of Compensation Structure ,   Covered Agent Information Sheets Workbook ,   Compensation Structure for Writing Agents by Contract/PBP Number
State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))

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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: The currently approved ROCIS table incorrectly sets out 7,588,143 hours of burden. This was mistakenly carried over from the 06/19/2015 Supporting Statement. The 10/27/2015 Supporting Statement correctly sets out 8,581,027 hours of burden, a difference of 992,884 hours. We are not proposing any changes to Supporting Statement sections 12.1. (Business Continuity Plans) for the private sector, 12.2. (Medicare Prescription Drug Benefit Program) for individuals/households, and 12.4. (State Eligibility Determinations) for states. However, in section 12.3. (Medicare Prescription Drug Benefit Program) we propose a number of private sector burden adjustments. We also propose to add requirements/burden in line with the proposed rule’s (CMS-4182-P, RIN 0938-AT08) CARA provisions in addition to new burden associated with the NPRM’s Access to Covered Part D Drugs; Preclusion List.”

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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: 12/26/2017

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