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
05/31/2017
36 Months From Approved
11/30/2017
230
0
239
2,109
0
2,193
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).
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. 108 - 173 1860D Name of Law: Medicare Prescription Drug
Benefit Program
PL:
Pub.L. 111 - 148 6005 Name of Law: Pharmacy benefit managers
transparency requirements
We have adjusted our cost
estimates by using the most recent BLS wage estimates. Overall, the
estimated hour burden for completion of the prescription drug
applications is 2,109 hours. This is an 84 hour decrease from the
2016 prescription drug application. Based on prior years'
experience CMS has determined that the estimated the number of 2017
applicants should be adjusted by -9 to properly reflect the
decrease in MAPD organizations seeking to apply to contract with
CMS. Specifically, CMS estimates that for 2017 there will be as
many applications as were actually received for 2016, and the
majority of those received will be expansions of existing
contracts, which require 60% fewer hours to complete. The overall
paperwork burden is decreased for PDP, MA-PD, Cost Plan, PACE, EGWP
Plan, and SAE applicants because of the decrease in the estimated
number of applicants. The burden per applicant has increased
slightly for initial applicants because of the addition of one to
three attestations, depending on application type.
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.