Terms of the
previous clearance remain in effect. OMB files this comment in
accordance with 5 CFR 1320.11( c ). This OMB action is not an
approval to conduct or sponsor an information collection under the
Paperwork Reduction Act of 1995. This action has no effect on any
current approvals. If OMB has assigned this ICR a new OMB Control
Number, the OMB Control Number will not appear in the active
inventory. For future submissions of this information collection,
reference the OMB Control Number provided. OMB is withholding
approval at this time. Prior to publication of the final rule, the
agency should provide a summary of any comments related to the
information collection and their response, including any changes
made to the ICR as a result of comments. In addition, the agency
must enter the correct burden estimates.
Inventory as of this Action
Requested
Previously Approved
11/30/2021
36 Months From Approved
11/30/2021
625,627,848
0
625,627,848
8,683,706
0
8,683,706
5,733,706
0
5,733,706
Part D plans and, to the extent
applicable, MA organizations will use the information discussed
below to comply with the eligibility and other requirements
associated with their participation in Part D. CMS will use this
information from plan sponsors and States to approve contract
applications, monitor compliance with contract requirements, make
proper payment to plans, and ensure that correct information is
disclosed to potential and current enrollees. The new information
collection will allow CMS to ensure sponsors have plans in place to
restore business operations following a disruption of regular
operations. Medicare beneficiaries will use the information
provided by the Part D sponsors to make decisions regarding Part D
enrollment as well as grievance and appeal requests. Under
CMS-4182-P (RIN 0938-AT08), CMS will make the Preclusion List
available to Part D sponsors. The Part D sponsors will perform
system programming to maintain the Preclusion List in order to
reject a pharmacy claim (or deny a beneficiary request for
reimbursement) for a Part D drug that is prescribed by an
individual on the Preclusion List. CMS will create and disseminate
model notices to the prescribers to notify them of their existence
on the Preclusion List, while the Part D sponsors will create and
disseminate model notices to the Medicare beneficiaries to notify
them that the pharmacy claim is being rejected or denied due to the
prescriber’s existence on the Preclusion List.
Statute at
Large: 18
Stat. 1860 Name of Statute: null
PL:
Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA)
PL: Pub.L. 108 - 173 101 Name of Law:
Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA)
This 2020 iteration proposes
non-rule changes along with changes associated with a proposed rule
(CMS-4190-P; RIN 0938-AT97) that published in the Federal Register
on February 18, 2020 (85 FR 9002). See section 15 of the Supporting
Statement for details.
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.