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
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.