Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts (CMS-10137)

Forms and Documents

Document Name	Status
Form CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts Form and Instruction	Modified
Attachment 3.docx Supplementary Document	2017-11-15
Attachment 2.docx Supplementary Document	2017-11-15
Attachment 1.docx Supplementary Document	2017-11-15
Part_D_Summ_2019_Application_Revisions_technical__substantive_v30_day CMS 10137 OMB 938 936.docx Supplementary Document	2017-11-15
Response to 60 Day Comments CMS 10137 OMB 938 936.doc Supplementary Document	2017-11-15
CMS-10137 - Supporting Statement A - Passback_CMS Responses 12212017 (rev OSORA PRA) CLEAN.docx Supporting Statement A	2017-12-21

IC Document Collections

IC ID	Document Title	Status
43672	Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0936	ICR Reference No: 201711-0938-001
Status: Historical Active	Previous ICR Reference No: 201610-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts (CMS-10137)
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: 12/22/2017
	Date Received in OIRA: 11/15/2017
Terms of Clearance: Previous Terms of Clearance/Comments: Previous terms continue: This ICR is approved for 12 months as it is associated with CMS's annual "Call Letter." Since the Call Letter discusses the information to be contained in the applications and the method by which they shall be submitted to CMS, in the Call Letter CMS shall (a) provide a reference to this OMB control number whenever the Part D application requirements are discussed, (b) provide an estimate of the burden entailed, and (c) indicate that CMS has issued a 60 day Federal Register notice for this ICR inviting public comments on the burden estimates and utility associated with this collection. CMS shall ensure that enough time is provided to the public to allow for both the 60 day and 30 day public comment periods. Per the PRA, OMB approval must be secured prior to the date by which Medicare Part D plans will need to submit these applications. The timing of the Call Letter and the 60 day and 30 day Federal Register notices should therefore be carefully considered and coordinated. Consistent with the PRA, this ICR should be re-submitted along with the publication of the draft "forthcoming guidance" documents to the extent the guidance document will result in new information collection, recordkeeping, or disclosure requirements or result in changes to burden or capital costs from existing requirements.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	01/31/2018
Responses	243	0	160
Time Burden (Hours)	2,240	0	1,565
Cost Burden (Dollars)	0	0	0

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Abstract: The Applications for Part D sponsors to offer qualified prescription drug coverage are completed by entities seeking approval to offer Part D benefits under the Medicare Prescription Drug Benefit program established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D of the Social Security Act (the Act).

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Authorizing Statute(s): PL: Pub.L. 111 - 148 3310 Name of Law: Reducing Wasteful dispensing of outpatient drugs in LTC facilities
   PL: Pub.L. 111 - 148 3314 Name of Law: Including cost incurred by AIDS drug assistance programs and Indian Health services
   PL: Pub.L. 108 - 173 1860D Name of Law: Medicare Prescription Drug Benefit Program
   Statute at Large: 18 Stat. 1860 Name of Statute: null
   PL: Pub.L. 111 - 148 6005 Name of Law: Pharmacy benefit managers transparency requirements
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 35782	08/01/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 48719	10/19/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts	CMS-10137, CMS-10137	Medicare Part D Application for New PACE Organizations (2018 Contract Year) ,   Solicitation for Applications for Medicare Prescription Drug Plan 2019 Contracts

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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	243	160	0	0	83	0
Annual Time Burden (Hours)	2,240	1,565	0	0	675	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: During the 60-day comment period, one comment was received which suggested adding “computers and other electronic records” to the list of examples of records that HHS and the Comptroller General are entitled to. We made the requested change. Neither the burden nor the substantive meaning of the attestation changed as a result. The burden per applicant has not changed since the 2018 application cycle. On average, we continue to anticipate that it will take each applicant 11.5 hours to complete their application (this represents an average of the number of hours spent on the application by each type of applicant). There were no substantive changes to the application for 2019. The only changes were changes in dates and minor language edits. Overall, the estimated time for completing the prescription drug applications is 2,239.71 hours. This is a 674.71 hour increase from the estimate of 1,565 hours for the 2018 prescription drug application. However, the actual number of 2018 applicants was much higher than anticipated, so the burden for the number of applications received for 2018 was 2,338 hours, 98.29 hours more than the estimated burden for 2019. We also anticipate that 7 more organizations will apply for PACE contracts in 2018 because the program has been opened to for-profit organizations. The 2019 estimates are based on an average of the number of applications received annually between the 2014 and 2018 application cycles and are therefore higher than estimated for 2018. The overall estimated paperwork burden is increased for PDP, MA-PD, Cost Plan, EGWP Plan, PACE, and SAE applicants because of the increase in the estimated number of applicants. The hourly burden per applicant has remained the same for all types of applicants. Based on more recent BLS wage data, we have also increased our wage estimate by $1.02/hr (from $66.52/hr to $67.54/hr).

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Annual Cost to Federal Government: $140,000

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]? Yes

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: 11/15/2017

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