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
12/31/2011
36 Months From Approved
01/31/2011
295
0
453
3,576
0
11,919
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
The Part D applications have been revised, and as a result, decreased the burden due to removing redundant sections of the applications and further automation of the application submission process. Further, legislation was enacted and regulations were issued since the last revision of these documents. As a result, new attestation sections were added to the overall applications and many attestations were clarified or corrected to address current CMS policy.
$140,000
No
No
Yes
No
No
Uncollected
Bonnie Harkless 4107865666
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.
Form CMS-10137 Cost CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP
Summ_2012_Application_Revisions_technical and substantive.pdf
2012 Part D 60 Day Comments Final CMS-10137.xls
2012 PDP formatted_rl30day.doc
CY 2012-Applications for Medicare Part D Plans; PDP Plans, MA-PD Plans, Cost Plans, PACE Organizations, SAE and EGWP