View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1445
ICR Reference No:
202408-0938-004
Status:
Active
Previous ICR Reference No:
202305-0938-020
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CMCS
Title:
[Medicaid] Medicaid Managed Care and Supporting Regulations (CMS-10855)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/17/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/24/2024
Terms of Clearance:
OMB is approving this information collection request for a period of one years under this new control number, during which time the agency will request approval to shift this collection under OMB 0938-0920 as appropriate and discontinue this control number.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2026
36 Months From Approved
Responses
604
0
0
Time Burden (Hours)
8,614
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This collection of information request is associated with our September 26, 2024 (89 FR 79020) final rule (CMS-2434-F; RIN 0938-AU28). We intend to fold the following collection of information requirements and burden estimates under CMS-10108 (OMB 0938-0920). However, there are a number of conflicting activities that make this impractical at this time. To address those conflicts, as a stop gap measure we are proposing to submit the collection of information requirements and burden estimates under CMS-10855 (OMB 0938-1445). When ready we will be folding them to their proper place under CMS-10108 (OMB 0938-0920). Most Medicaid beneficiaries receive either all or part of their health care benefits through Medicaid managed care programs, including their prescription drug benefits. Because of the specialized nature of the prescription drug benefit, many of the Medicaid managed care plans (MCOs, PIHPS, or PAHPS) either own, or contract with, PBMs to administer the pharmacy benefit. In § 438.3(s), Medicaid MCOs, PIHPs, and PAHPs that provide coverage of covered outpatient drugs (CODs) would be required to structure any contract that it has with any subcontractor (e.g., PBM) for the delivery or administration of the COD benefit so that the subcontractor is required to report separately the amounts related to the incurred claims described in § 438.8(e)(2) to the managed care plan. The provisions would ensure that medical loss ratios (MLRs) reported by MCOs, PIHPs and PAHPs that use subcontractors in the delivery of COD coverage would be more accurate and transparent. The separate payment requirements would help States and managed care plans better understand whether they are appropriately and efficiently paying for the delivery of CODs, a significant part of which is funded by the Federal Government.
Authorizing Statute(s):
US Code:
42 USC 1396a
Name of Law: Social Security Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AU28
Final or interim final rulemaking
89 FR 79020
09/26/2024
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
88 FR 34238
05/26/2023
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 79020
09/26/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Managed Care Plans' and their Subcontractors: Identify Costs and Report
States: Require plans to Structure their Subcontracts
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
604
0
0
604
0
0
Annual Time Burden (Hours)
8,614
0
0
8,614
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
For States, we estimate a one-time burden of 40 responses/respondents, 1,000 hours, and $91,920. For the private sector (managed care plans and PBMs) we estimate an annual burden of 564 responses/respondents, 7,614 hours, and $699,879. Overall, we estimate a burden of 604 responses/respondents, 8,614 hours, and $791,799. There are no reporting instruments or instructions other that what is set out in CMS-2434-F and what is codified in the CFR.
Annual Cost to Federal Government:
$11,756
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
10/24/2024