CMS-10825 - Supporting Statement_A (CMS-4208-P version 7)

Supporting Statement Part A

List of Screening Instruments for Housing Stability, Food Security, and Transportation Questions on Health Risk Assessments (HRAs) and Requirements for Integrated HRAs

(CMS-10825, OMB 0938-1446)

Background

Our Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs final rule (May 9, 2022; 87 FR 27704) (CMS-4192-F, RIN 0938-AU30) (hereinafter referred to as the May 2022 final rule) finalized regulations related to Medicare Advantage (MA) dual eligible special needs plans (D-SNPs) and other special needs plans (SNPs). The rule notes that we will update to the CMS SNP Care Coordination audit protocols¹ to ensure the completed HRAs include the assessment of housing stability, food security, and access to transportation based on the list of screening instruments specified by CMS in sub-regulatory guidance. The changes to SNP audit protocols will be submitted to OMB for approval under control number 0938-1395 (CMS-10717). The HRA requirement is part of the Model of Care Submissions information collection, control number OMB 0938-1296 (CMS- 10565).

This information collection request is related to the regulation at 42 CFR 422.101(f)(1)(i) requiring that all MA SNP HRAs include questions on housing stability, food security, and access to transportation. This information collection request provides the list of CMS specified screening instruments available for SNPs to meet that requirement. Outside of updating the PRA Disclosure Statement, we have not made any changes to the list.

This information collection request is also related to our December 10, 2024 (89 FR 99340) Contract Year 2026 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs proposed rule (CMS-4208-P, RIN 0938-AV40) (hereinafter referred to as the “December 2024 proposed rule”) proposes regulations to require D-SNPs that are AIPs to conduct a comprehensive HRA that meets all Medicare and Medicaid requirements, rather than two separate HRAs.

This request also removes outdated one-time burden estimates for requirements that have been met.

This iteration would add 26 responses and 546 hours and remove 174 responses and 167 hours. Overall, the final burden is 26 responses and 546 hours.

1. Justification

1. Need and Legal Basis

Section 1859(f)(5)(A)(ii)(I) of the Social Security Act (hereinafter referred to as the Act) requires each SNP to conduct an initial assessment and an annual reassessment of the individual’s physical, psychosocial, and functional needs. We previously codified this requirement at § 422.101(f)(1)(i) as a required component of the SNP’s model of care. In current practice, we allow each SNP to develop its own HRA, as long as it meets the statutory and regulatory requirements. In the May 2022 final rule, we amended § 422.101(f)(1)(i) to require that all SNPs (chronic condition special needs plans, D-SNPs, and institutional special needs plans) include one or more questions on the topics of housing stability, food security, and access to transportation as part of their HRAs.

Separate from the Medicare requirements at § 422.101(f)(1), Medicaid managed care regulations at § 438.208(b)(3) require Medicaid managed care plan to make a best effort to conduct an initial screening of enrollee needs within 90 days of their effective date, and State requirements may include additional assessments such as long-term services and supports (LTSS) and home and community-based services eligibility screening. While some states have implemented their own requirements, through state Medicaid agency contracts, to reduce burden and duplication, not all states have done so. In the December 2024 proposed rule, we propose to require D-SNPs that are applicable integrated plans (AIPs) to conduct a comprehensive HRA that meets all Medicare and Medicaid requirements, rather than two separate HRAs.

2. Information Users

MA organizations with SNPs would use the information collected from an enrollee’s answers to questions in the HRA to help identify risk factors that may inhibit the enrollee from accessing care and achieving optimal health outcomes. At this time, CMS will not collect or analyze the information gathered from enrollees by MA organizations under this information collection request.

3. Improved Information Technology

MA organizations can use automated, electronic, mechanical, or other technological collection techniques or other forms of information technology to collect data related to this information collection as long as the use of such techniques adheres to the regulations at § 422.101(f).

4. Duplication of Similar Information

This information collection does not duplicate any other effort and the information cannot be obtained from any other source.

5. Small Businesses

There is no significant impact on small businesses.

6. Less Frequent Collection

Section 1859(f)(5)(A)(ii)(I) of the Act requires SNPs to conduct an initial assessment and reassessment annually. We estimate that half of the contracts that would be affected by our proposal currently conduct two HRAs. Under our proposals to require integrated HRAs, these 13 contracts would have less frequent collection because they would only administer one HRA rather than two.

7. Special Circumstances

There are no special circumstances to report, and no statistical methods will be employed. More specifically this collection:

• Does not require respondents to report information to the agency more often than quarterly;

• Does not require respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• Does not require respondents to submit more than an original and two copies of any document;

• Does not require respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• Is not connected with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• Does not require the use of a statistical data classification that has not been reviewed and approved by OMB;

• Does not include a pledge of confidentiality that is not supported by authority established in statue or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• Does not require respondents to submit proprietary trade secret, or other confidential information, unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

8. Federal Register Notice/Outside Consultation

Serving as the 60-day notice, our proposed rule (CMS-4208-P, RIN 0938-AV40) filed for public inspection on November 26, 2024, and published in the Federal Register on December 10, 2024 (89 FR 99340). Comments must be received no later than 5 p.m. Eastern Time on January 27, 2025.

9. Payments/Gifts to Respondents

This collection provides zero payments or gifts to Medicare Advantage organizations.

10. Confidentiality

CMS will not collect data from the HRAs administered by MA organizations. Personally identifiable information contained in the HRAs is protected by the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA) standards for MA plans and their providers. Thus, CMS assurance of confidentiality is not applicable to this collection.

11. Sensitive Questions

The questions on housing, food insecurity, and transportation in the HRAs could be considered sensitive. However, we do not believe these questions are any more sensitive than other HRA questions on the enrollee’s physical, psychosocial, and functional needs. We believe requiring SNPs to include questions about social risk factors is appropriate in light of the impact these factors may have on health care and outcomes for the enrollee. Access to this information will better enable SNPs to design and implement effective care plans for their enrollees.

12. Collection of Information Requirements and Associated Burden Estimates

Wage Estimates

To derive mean costs, we are using data from the most current U.S. Bureau of Labor Statistics’ (BLS’s) National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/oes/2023/may/oes_nat.htm), which, at the time of drafting of this rule, provides May 2023 wages. In this regard, the following table presents BLS’ mean hourly wage along with our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage.

Table 1: National Occupational Employment and Wage Estimates

Occupation Title	Occupation Code	Mean Hourly Wage ($/hr)	Fringe Benefits and Other Indirect Costs ($/hr)	Adjusted Hourly Wage ($/hr)
Business Operations Specialists	13-1000	42.85	42.85	85.70

As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent to account for fringe benefits and other indirect costs that vary from employer to employer and because methods of estimating these costs vary widely from study to study. We believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

Collection of Information Requirements and Associated Burden Estimates

As described in CMS-4208-P, we are proposing to require D-SNPs that are AIPs to conduct a comprehensive HRA that meets all Medicare and Medicaid requirements, rather than two separate HRAs.

If this provision is finalized, AIPs in seven states (DC, FL, ID, NJ, PR, VA, and WI) that do not currently combine their HRAs would be required to adhere to this new provision. We believe that in plan year 2026, a business operation specialist associated with each contract that has an AIP in these seven states would spend an average of 2 hours to determine whether the HRA tool currently in use meets State requirements (or the Medicaid HRA tool in use meets Medicare requirements) and make any necessary system updates in preparation for implementation in plan year 2027. With 26 unique contracts in the seven states that would be required to meet this provision, we estimate that half of the contracts or 13 contracts (26 contracts * ½) will only need to make minor administrative changes to comply with this provision. This would be a one-time burden of 26 hours (13 contracts* 2 hr) at a cost of $2,228 (26 hr * $85.70/hr).

We estimate that the other half of the contracts (13 contracts) would require more extensive updating and merging of two separate HRA tools (at 40 hr/response) to comply with this provision. We estimate such MA organizations would need to merge two separate HRA tools and implement systems updates to operationalize the integrated HRA. We estimate that these activities would take 40 hours per contract. This would be a one-time burden of 520 hours (13 contracts * 40 hr) at a cost of $ 44,564 (520 hr * $85.70/hr).

After initial implementation, this proposed requirement would reduce burden for AIPs in the seven states listed above with HRAs that are not already integrated, as plans would be conducting one integrated HRA instead of two. As discussed in the prior paragraph, we estimate that half of the contracts that would be affected by our proposal currently administer some form of a consolidated HRA. Conversely, we estimate that the other half of the contracts are currently conducting two HRAs. Based on this assumption, we are estimating that half of the contracts that would be required to adhere to this provision if it is finalized would see a reduction of burden by half. We expect some long-term burden reduction from the 13 contracts that currently administer two HRAs for their enrollees but would only administer one HRA under this proposal.

Burden Summary

Table 2: Burden Summary

Section in Title 42 of the CFR	Item	Number of respondents	Total Responses	Time per Response (hours)	Total Time (hours)	Hourly Labor Cost($/hr)	Total Cost First Year ($)	Total Cost Subsequent years ($)
422.101	Integrated HRAs (minimal work)	13 (D-SNP Parent Organizations)	13	2	26	87.50	2,228	0
422.101	Integrated HRAs (Work to integrate HRAs)	13 (D-SNP Parent Organizations)	13	40	520	87.50	44,564	0
TOTAL		13	26	varies	546	87.50	46,792	0

Collection of Information Instruments and Instruction/Guidance Documents

See Appendix A: List of screening instruments for CY 2024 requirement to include one or more questions on housing stability, food security, and access to transportation in health risk assessments.

Appendix A is related to the requirement for MA SNPs at § 422.101(f)(1)(i). Outside of revising the PRA Disclosure Statement, we have not made any changes to the list.

13. Capital Costs

There are no capital costs.

14. Cost to the Federal Government

We estimate that the costs associated with this information collection to the Federal Government include time and cost for one GS-13, Step 1 position for drafting any future guidance related to the requirement for integrated HRAs. We estimate this to be a one-time cost of $9,074 in the first year and an annual cost of $2,269 in subsequent years, as summarized in table below.

The calculations for Federal employees’ hourly salary are obtained from the OPM website reflecting the 2024 salary table, with an additional 100% to account for fringe benefits and other indirect costs.

Task	Estimated Costs
Initial research, review, and drafting of guidance	One-time cost
1 GS-13, Step 1: $113.43 x 80 hr	$9,074
Review and potential updates to guidance	Annual cost
1 GS-13, Step 1: $113.43 x 20 hr	$2,269

The average annual cost to the Federal Government is $5,294 ($9,074/3 years + $2,269).

15. Program/Burden Changes

Screening Instruments

We estimated a one-time burden for CY 2024 for the parent organizations offering SNPs to update their HRA tools in their care management systems and adopt questions on housing stability, food security, and access to transportation, in cases where the SNPs are not already asking questions on the required topics. We propose to remove such burden since it was a one-time burden that has been met.

Section in Title 42 of the CFR	Item	Number of respondents	Total Responses	Time per Response (hours)	Total Time (hours)	Hourly Labor Cost ($/hr)	Total Cost First Year ($)	Total Cost Subsequent Years ($)
422.101	Update HRA System	45 (SNP Parent Organizations)	45	3	135	116.34	15,706	0
422.101	Register for VSAC username	129 (SNP Parent Organizations)	129	0.25	32	77.28	2,492	0
TOTAL		174 (SNP Parent Organizations)	174	varies	167	varies	18,198	0

Proposed Changes Under Contract Year 2026 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

The subject information collection requirements (ICRs) are related to our December 10, 2024 (89 FR 99340) NPRM (CMS-4208-P, RIN 0938-AV40). See section 12, above, for details.

Section in Title 42 of the CFR	Item	Number of respondents	Total Responses	Time per Response (hours)	Total Time (hours)	Hourly Labor Cost($/hr)	Total Cost First Year ($)	Total Cost Subsequent Years ($)
422.101	Integrated HRAs (minimal work)	13 (D-SNP Parent Organizations)	13	2	26	87.50	2,228	0
422.101	Integrated HRAs (Work to integrate HRAs)	13 (D-SNP Parent Organizations)	13	40	520	87.50	44,564	0
TOTAL		13	26	varies	546	87.50	46,792	0

Summary of Burden Changes

	Regulation Section in Part 42 of the CFR	Item	Number of respondents	Responses per respondent	Total Responses	Total Time (hours)	Labor Cost ($/hr)	Total Cost ($)
Currently Approved Burden	422.101(f)	Update HRA System	45 (SNP Parent Organizations)	(1)	(45)	(135)	123.80	(16,713)
Currently Approved Burden	422.101(f)	Register for VSAC username	129 (SNP Parent Organizations)	(1)	(129)	(32)	42.85	(1,382)
CMS-4208-P Burden	422.101(f)	Integrated HRAs (minimal work)	13 (D-SNP Parent Organizations)	1	13	26	85.70	2,228
CMS-4208-P Burden	422.101(f)	Integrated HRAs (Work to integrate HRAs)	13 (D-SNP Parent Organizations)	1	13	520	85.70	44,564
TOTAL			13	varies	148	379	n/a	28,697

Overall, this iteration would add 148 responses (174 - 26 responses) and 379 hours (546 hr - 167 hr).

16. Publication/Tabulation Dates

CMS does not intend to publish data related this collection of information.

17. Expiration Date

CMS will display the expiration date and OMB approval number on information collection materials.

18. Certification Statement

There are no exceptions to the certification statement.

2. Collections of Information Employing Statistical Methods

This collection does not employ statistical methods.

1 See https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and- Audits/ProgramAudits

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