Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, section 423.514 (CMS-10185)

Forms and Documents

Document Name	Status
CY2017 to CY2019 Crosswalk_020618.xlsx Supplementary Document	2018-12-07
60-Day Comment Response Document.xlsx Supplementary Document	2018-06-14
CY2017 to CY2019 Crosswalk_051518.xlsx Supplementary Document	2018-06-14
CMS-10185 - Supporting Statement A_06142018 - Passback2_MDBG Edits CLEAN.docx Supporting Statement A	2018-12-07

IC Document Collections

IC ID	Document Title	Status
8853	Medicare Part D Reporting Requirements Instruction	Modified

ICR Details

OMB Control No: 0938-0992	ICR Reference No: 201806-0938-006
Status: Historical Active	Previous ICR Reference No: 201609-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, section 423.514 (CMS-10185)
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: 12/07/2018
	Date Received in OIRA: 06/15/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	01/31/2020
Responses	13,603	0	11,438
Time Burden (Hours)	17,365	0	14,750
Cost Burden (Dollars)	0	0	818,775

---

Abstract: MMA provides CMS the statutory authority to require all Part D Sponsors (MA-PDs and PDPs) to report data related to their operational costs and services. These data will be analyzed for oversight and monitoring purposes, as well as potentially initiating other groups within the agency to perform functions such as fraud/waste/abuse investigations, audit activities, and compliance. Title I, Part 423, ?423.514 describes CMS' regulatory authority to establish reporting requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics in the following areas: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation. (5) Other matters that CMS may require. Subsection 423.505 of the MMA regulation establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS.

---

Authorizing Statute(s): Statute at Large: 1 Stat. 423 Name of Statute: null
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 8679	02/28/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 26691	06/08/2018
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Medicare Part D Reporting Requirements

---

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	13,603	11,438	0	2,726	-561	0
Annual Time Burden (Hours)	17,365	14,750	0	3,176	-561	0
Annual Cost Burden (Dollars)	0	818,775	0	0	-818,775	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: No

Burden Reduction Due to:

Short Statement: For the CY2019 Reporting Requirements, we removed the Retail, Home Infusion and Long-Term Care Pharmacy Access section since the data are no longer necessary for monitoring through these reporting requirements. There was an overall increase in contract respondents (from 561 to 627) and plan respondents (from 4,036 to 5,234) due to an increase in the total number of Part D contracts. Overall, there was an increase in responses (from 11,438 to 13,603) and total time (from 14,750 hr to 17,365 hr).

---

Annual Cost to Federal Government: $300,000

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

---

Common Form ICR:  No

---

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: 06/15/2018

---