The Medicare Advantage and
Prescription Drug Program: Part C Explanation of Benefits and
Supporting Regulations (CMS-10453) - IRA
Reinstatement with change of a previously approved collection
No
Regular
12/21/2023
Requested
Previously Approved
36 Months From Approved
1,065
0
10,650
0
0
0
Section 11201 of the IRA makes
significant changes to the Part D benefit design which require CMS
to make corresponding revisions to the Part D EOB model. Beginning
in 2024, the IRA revises section 1860D-2(b)(4)(A)(i)(II) of the Act
to eliminate enrollee cost sharing after the enrollee has incurred
costs equal to the annual out-of-pocket threshold specified in
section 1860D-2(b)(4)(B)(i) of the Act. Beginning in 2025, the IRA
eliminates the coverage gap benefit phase, sunsets the Coverage Gap
Discount Program, and introduces new manufacturer discounts in the
initial and catastrophic coverage phases. Medicare Advantage
organizations (MAOs) and Medicare Prescription Drug Program (Part
D) plan sponsors are required to provide their enrollees with a
written explanation of benefits (EOB) when benefits are provided
under the plan. Section 1860D-4(a)(4) of the Social Security Act,
requires that Part D sponsors distribute to enrollees a notice of
benefits used in relation to the Part D initial coverage limit and
annual out-of-pocket threshold. CMS codified Part D EOB
requirements at 42 CFR § 423.128(e). Section 1852(k)(2)(C)(i) of
the Act requires MAOs that offer a private fee-for-service (PFFS)
plan to provide enrollees with a written EOB, including a clear
statement about the enrollee’s liability, when payment is sought
under the plan. CMS regulations specifying that all MAOs provide an
EOB when Part C benefits are used are codified at 42 CFR §
422.111(k). Information in this collection is needed to ensure that
MA and Part D enrollees receive consistent and timely information
about costs associated with their medical claims. Part C and Part D
EOBs allow enrollees to track their out-of-pocket expenses and
benefit utilization in relation to their plan’s deductible and
out-of-pocket threshold.
PL:
Pub.L. 110 - 275 103 Name of Law: The Medicare Improvements for
Patients and Providers Act of 2008.
PL:
Pub.L. 108 - 117 201 Name of Law: The Medicare Prescription
Drug Improvement, and Modernization Act of 2003
PL:
Pub.L. 117 - 169 11201 Name of Law: The Inflation Reduction Act
of 2022
PL: Pub.L. 117 - 169 11201 Name of Law: the
Inflation Reduction Act of 2022
CMS revised the burden
associated with programming Part C and Part D EOBs, and, for Part D
(one-time burden) to implement the redesign, corrections, and
IRA-related changes. CMS removed the annual hourly burden
associated with preparing individual EOBs because after changes to
the EOBs are programmed, the production is automated. Thus, the
previously approved annualized hourly burden estimate for preparing
Part C EOBs has been removed because there are no changes to the
Part C EOB templates and we assume the production is automated once
EOB templates are programmed.
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-10453 EOB
CMS-10453 - Supporting Statement A.docx
Comments Received 2025 EOB PRA Package 60 day.pdf
EOB