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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10141 2019 Part C and D Sample Precluded Provider Letter	Form	Modified	Available
Form CMS-10141 Alternate Second Notice	Form	Modified	Available
Form CMS-10141 Second Notice: Your Access to Certain Part D Drugs is Limited	Form	Modified	Available
Form CMS-10141 Initial Notice: Notice of Intent to Limit Your Access to Certain Part D Drugs	Form	Modified	Available
Form CMS-10141 Compensation Structure for Writing Agents by Contract/PBP Number	Form	Modified	Available
Form CMS-10141 Covered Agent Information Sheets Workbook	Form	Modified	Repair queued
Form CMS-10141 Description of Compensation Structure	Form	Modified	Available
Form CMS-10141 Compensation Certification	Form	Modified	Available
CMS-10141 - Supporting Statement A (version 3).docx	Supporting Statement A	Uploaded 2018-12-20	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8823	Medicare Prescription Drug Benefit Program (Benes)		Unchanged
231341	Preparation and Issuance of Model Notices (section 423.120(c)(6))		Unchanged
231340	Creation of Model Notices (Plans) (section 423.120(c)(6))		Unchanged
231339	System Programming (Plans) (section 423.120(c)(6))		Unchanged
217122	Business Continuity Plans under 422.504(o) and 423.505(p)		Unchanged
209891	State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))		Unchanged
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	2019 Part C and D Sample Precluded Provider Letter
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Alternate Second Notice
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Second Notice: Your Access to Certain Part D Drugs is Limited
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Initial Notice: Notice of Intent to Limit Your Access to Certain Part D Drugs
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Compensation Structure for Writing Agents by Contract/PBP Number
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Covered Agent Information Sheets Workbook
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Description of Compensation Structure
187164	Medicare Prescription Drug Benefit Program (Plans)	Form	Modified	Compensation Certification
187164	Medicare Prescription Drug Benefit Program (Plans)	Instruction	Modified

ICR Details

OMB Control No: 0938-0964	ICR Reference No: 201812-0938-017
Status: Historical Inactive	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: Comment filed on proposed rule and continue	Conclusion Date: 01/29/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/21/2018
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. 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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved	11/30/2021
Responses	54,426,919	0	54,426,919
Time Burden (Hours)	8,667,195	0	8,667,195
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
   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	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: 7

table that charts list of burden

IC Title	Form No.	Form Name
Preparation and Issuance of Model Notices (section 423.120(c)(6))
Business Continuity Plans under 422.504(o) and 423.505(p)
Creation of Model Notices (Plans) (section 423.120(c)(6))
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	Compensation Certification ,   Description of Compensation Structure ,   Covered Agent Information Sheets Workbook ,   Compensation Structure for Writing Agents by Contract/PBP Number ,   Initial Notice: Notice of Intent to Limit Your Access to Certain Part D Drugs ,   Second Notice: Your Access to Certain Part D Drugs is Limited ,   Alternate Second Notice ,   2019 Part C and D Sample Precluded Provider Letter
State Eligibility Determinations (423.904(b)) and Reporting (423.910(d))
System Programming (Plans) (section 423.120(c)(6))

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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: We propose to add burden based on the rule’s (CMS 4180-P, RIN 0938 AT08) Part D Explanation of Benefits Drug Pricing Provision. For this provision the burden includes the time and effort needed to link alternative prices to the EOB model. We assume a half day (4 hr) for a software programmer for each contract (757) to link drug prices to the Part D EOB model, for a one time burden of +3,028 hours (757 x 4).

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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: 12/21/2018

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