Applications for Medicare Part D plans: PDP Plans, MA-PD Plans, Cost Plans, PACE organizations, SAE and EGWP

ICR 201211-0938-006

OMB: 0938-0936

Federal Form Document

ICR Details
0938-0936 201211-0938-006
Historical Active 201111-0938-002
HHS/CMS
Applications for Medicare Part D plans: PDP Plans, MA-PD Plans, Cost Plans, PACE organizations, SAE and EGWP
Revision of a currently approved collection   No
Regular
Approved with change 12/20/2012
Retrieve Notice of Action (NOA) 11/21/2012
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
12/31/2015 36 Months From Approved 02/28/2013
241 0 178
2,132 0 2,322
0 0 0

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).

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 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. 111 - 148 6005 Name of Law: Pharmacy benefit managers transparency requirements
  
None

Not associated with rulemaking

  77 FR 40064 07/06/2012
77 FR 62241 10/12/2012
Yes

1
IC Title Form No. Form Name
CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP CMS-10137, CMS-10137 Part D Application ,   2013 PACE Application

  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 241 178 0 0 63 0
Annual Time Burden (Hours) 2,132 2,322 0 -221 31 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
The 49% (12.5 hours) decrease to the burden hour for each Part D application reflects CMS' efforts to streamline the application instructions by combining four application instruction documents into one, leaving a single document for the PDP, MA-PD, Cost, and Service Area Expansion applications, and a unique PACE application. Additionally, CMS reviewed all attestations across all five applications, and eliminate 221 unique attestations by removing attestations for highly technical elements and replacing with broad language asking applicants to affirm that they have read, understand, and complies with regulatory and sub-regulatory guidance. CMS maintained the structure of the Service Area Expansion application, and it continues to be comprised of approximately 30% of the full applications' attestations, the same pharmacy network upload requirements, and does not collect contracting, management and operations, compliance plan, or financial solvency documentation from applicants. The burden hours represent the time it takes for an applicant to complete the Part D solicitation and not the time that applicants spend drafting and negotiating contracts with downstream and related entities to perform key Part D functions on their behalf.

$140,000
No
No
Yes
No
No
Uncollected
William Parham 4107864669

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/21/2012


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