[Medicaid] Medicaid Managed Care and Supporting Regulations (CMS-10855)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-10855 - Response to 60-Day NPRM Comments (2024 version 3).docx	Supplementary Document	Uploaded 2024-10-24	Missing upstream
CMS-10855 - Supporting Statement A (CMS-2434-F version 8).docx	Supporting Statement A	Uploaded 2024-10-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
260421	Managed Care Plans' and their Subcontractors: Identify Costs and Report		Modified
260419	States: Require plans to Structure their Subcontracts		Modified

ICR Details

OMB Control No: 0938-1445	ICR Reference No: 202408-0938-004
Status: Received in OIRA	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	Date Submitted to OIRA: 10/24/2024

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	604	0
Time Burden (Hours)	8,614	0
Cost Burden (Dollars)	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

table that charts list of burden

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

table that charts list of burden

	Total Request	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

---

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

---