CMS-10209 - Supporting Statement A [rev 11-28-2017 by OSORA PRA]

Supporting Statement Part A

Medicare Advantage Chronic Care Improvement Program (CCIP) and

Quality Improvement Project (QIP) Attestations

CMS-10209, OMB 0938-1023

Background

Section 1852(e) of the Social Security Act requires that MA organizations (MAOs) have an ongoing quality improvement program. CMS regulations at 42 CFR 422.152 outline the quality improvement program (QI Program) requirements for MA plans, which includes a number of activities including the development and implementation of both a Quality Improvement Project (QIP) and a Chronic Care Improvement Program (CCIP).

A CCIP is a clinically focused initiative designed to improve the health of a specific group of enrollees with chronic conditions. Each MAO is required to conduct, over a 3-year period, a CCIP that focuses on the effective management of chronic disease for a chronically ill population.

QIPs are initiatives focused on one or more clinical and/or non-clinical areas with the aim of improving health outcomes and beneficiary satisfaction. Each MAO is required to conduct, over a 3-year period, a QIP that addresses one or more of the CMS Quality Strategy Goals.

MAOs must conduct the same CCIP and QIP for all their non-SNP coordinated care plans offered under a specified contract, including employer group plans and Medical Savings Account plans (MSA) and Private Fee for Service (PFFS) plans that have contracted networks. MAOs must also implement a CCIP and QIP for each SNP type/subtype offered under a specified contract.

Non Rule-Related Changes

In this information collection request, MAOs would no longer be required to submit CCIP and QIP progress reports to CMS annually. In its place, we have transitioned to an annual attestation requirement. By December 31, 2017, MAOs will be required to attest that they have ongoing CCIPs and QIPs electronically via the Health Plan Management System (HPMS).

The attestation involves no reporting of information or data. Consequently, the attestation requirements and burden are not subject to OMB approval under the PRA.

Proposed Rule-Related Changes

Over time, CMS found its implementation of both QIP and CCIP requirements had become burdensome and duplicative of other quality initiatives. Therefore, the proposed rule (CMS-4182-P; RIN 0938-AT08) would remove the QIP attestation requirement and allow MA organizations to focus on a single quality project, the CCIP.

Unlike the non-rule related attestation which is exempt from the PRA, the rule-related attestation will require that MA organizations identify what conditions their CCIP projects are focusing on thereby making it subject to the requirements under the PRA.

We believe it is important for CMS to be aware of the clinical focus of the CCIP projects for monitoring purposes. The revised CCIP attestation requirement will be added through sub regulatory guidance upon the effective date of the final rule and upon OMB approval under the PRA process.

Justification

1. Need and Legal Basis

MAOs are required by CMS regulations at §422.152(a)(1), (2), and (3) to have an ongoing QI program that meets CMS requirements and includes at least one CCIP and one QIP. Every MAO must have a QI program that monitors and identifies areas where implementing appropriate interventions would improve patient outcomes and patient safety. The goal of the QI Program is to demonstrate a favorable effect on health outcomes, enrollee satisfaction, and encourage providers to participate in CMS QI initiatives that result in high quality healthcare being delivered to beneficiaries at all times.

2. Information Users

The collected attestation information will be used by CMS Central to monitor ongoing CCIP activities. Note that there is currently no contractor involvement in this project.

3. Use of Information Technology

Technology is used in the collection, processing and storage of the data. Specifically, MAOs must attest that they have an ongoing CCIP and QIP and identify the conditions on which these projects focus via CMS’ Health Plan Management System (HPMS) annually. The submission is 100% electronic.

4. Duplication of Efforts

This collection does not contain duplication of similar information.

5. Small Business

This collection does not impose a significant impact on small businesses and other entities.

6. Less Frequent Collection

Removal of QIP and CCIP annual reporting and transition to an annual attestation process reduces reporting burden to plans.

7. Special Circumstances

There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:

• Report information to the agency more often than quarterly;

• Prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• Submit more than an original and two copies of any document;

• Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,

• Use a statistical data classification that has not been reviewed and approved by OMB;

• Include a pledge of confidentiality that is not supported by authority established in statute 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

• 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/Outside Consultation

The November 28, 2017 (82 FR 56336), proposed rule (CMS-4182-P, RIN 0938-AT08) serves as the 60-day Federal Register notice.

9. Payments/Gifts to Respondents

There are no payments/gifts to respondents associated with this information collection request.

10. Confidentiality

Consistent with federal government and CMS policies, CMS will protect the confidentiality of the requested proprietary information. Specifically, only information within this collection (or attachments thereto) that constitutes a trade secret, privileged or confidential information, (as such terms are interpreted under the Freedom of Information Act and applicable case law), and is clearly labeled as such by the respondent, and which includes an explanation of how it meets one of the expectations specified n 45 CFR Part 5, will be protected from release by CMS under 5 U.S.C. 552(b)(4). Information not labeled as trades secret, privileged, or confidential or not including an explanation of why it meets one or more of the FOIA exceptions in 45 CFR Part 5 will not be withheld from release under section 552(b)(4).

11. Sensitive Questions

There are no sensitive questions associated with this collection. Specifically, the collection does not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

12. Burden Estimates (Hours and Wages)

Wages

To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2016 National Occupational Employment and Wage Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage.

Occupation Title	Occupation Code	Mean Hourly Wage ($/hr)	Fringe Benefits and Overhead ($/hr)	Adjusted Hourly Wage ($/hr)
Compliance Officer	13-1041	33.77	33.77	67.54

As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

Burden Estimates

As explained below in Section 15, the currently approved information collection request sets out burden for CCIP and QIP reports. This 2017 package iteration removes the CCIP and QIP reporting requirements/burden and proposes the following rule- and non rule-related changes.

Non Rule-Related Changes

In this information collection request, MAOs would no longer be required to submit CCIP and QIP progress reports to CMS annually. In its place, we have transitioned to an annual attestation requirement. By December 31, 2017, MAOs will be required to attest that they have ongoing CCIPs and QIPs electronically via the Health Plan Management System (HPMS).

The attestation involves no reporting of information or data. Consequently, the attestation requirements and burden are not subject to OMB approval under the PRA.

Additionally, §§422.152(a)(2) and 422.152(c)(2) state that MA plans must report the status and results of each program. CMS will require a few MAOs (no more than 5 annually) to upload information about the results and status of each program (QIP and CCIP) electronically each year. CMS will provide a template that MA plans may use as a reference for their electronic uploads. However, strict adherence to these templates will not be required. Since we estimate fewer than ten respondents, the information collection requirements are exempt from the requirements of the PRA (5 CFR 1320.3(c)).

Likewise, any follow up questions would be subject to the same number of respondents such that they would also be exempt under the same provision of the PRA’s implementing regulations.

Proposed Rule-Related Changes

Our proposed rule (CMS-4182-P; RIN 0938-AT08) would remove the QIP attestation requirement (see above for our discussion of non rule-related changes) such that MAOs will only be required to attest that they have an ongoing CCIP.

We believe it is important for CMS to be aware of the clinical focus of the CCIP projects for monitoring purposes. Therefore, the CCIP attestation will require that MA organizations identify what conditions their CCIP projects are focusing on. The requirement that MA organizations identify the clinical focus of their CCIP projects will not be effective until the requirement and burden is approved by OMB under the PRA and the final rule becomes effective.

By adding the revised CCIP attestation requirement, we estimate that it would take 0.25 hours at $67.54/hr for a compliance officer to complete their CCIP attestation electronically. In aggregate we estimate an annual burden of 187.5 hours (750 MA contracts x 0.25 hr) at a cost of $12,663.75 (187.5 hr x $67.54/hr) or $ 16.89 per MA contract ($12,663.75 / 750 MA contracts).

Information Collection/Reporting Instruments and Instruction/Guidance Documents

• CCIP Screen Shot – Attestation Form

MAOs are currently required to submit two electronic attestation forms annually: one for the CCIP and one for the QIP. The current attestation process involves no reporting of information or data. Therefore, the requirement/burden and OMB approval are not applicable to these attestations.

When the final rule becomes effective and when this information collection request is approved by OMB under the PRA, the current form - which is exempt from the PRA - will be replaced by the attached attestation form such that MAOs would be required to: (1) check a box certifying that they have an ongoing QIP or CCIP project in progress that meets the requirements laid out in regulation and sub regulatory guidance and (2) briefly identify (in 500 characters or less) what conditions the projects are focusing on.

13. Capital Costs

We do not anticipate additional capital costs. CMS requirements do not require the acquisition of new systems or the development of new technology to complete these reports.

14. Cost to Federal Government

By December 31, 2017, MAOs will be required to attest that they have ongoing CCIPs and QIPs electronically via the Health Plan Management System (HPMS). The attestation process involves no reporting of information or data. Therefore, the requirement/burden and OMB approval are not applicable to these attestations.

When the final rule becomes effective and when this information collection request is approved by OMB under the PRA, the current form - which is exempt from the PRA - will be replaced by the attached attestation form such that MAOs would be required to: (1) check a box certifying that they have an ongoing QIP or CCIP project in progress that meets the requirements laid out in regulation and sub regulatory guidance and (2) briefly identify (in 500 characters or less) what conditions the projects are focusing on.

Based on the budgeted amount per review and estimated wages of reviewers and support staff, we estimate it will take a single CMS reviewer no more than 15 minutes (0.25 hours) to review each submission. We assume a GS grade 13, step 5, with a mean wage of $51.48/hr, which with an allowance of 100% for overhead and fringe benefits becomes $102.96/hr. These estimates are based on a the salary of a single CMS reviewer at a GS 13, step 5 salary level in Washington, Baltimore, Arlington locality.¹

In aggregate, we estimate it would take 187.5 hours (750 MA contracts x 0.25 hr) at a cost of $19,305 (187.5 hr x $102.96/hr).

15. Changes to Burden

CCIP and QIP Reporting Tools (Removed Requirements/Burden)

We are removing the reporting requirement and burden (-28,560 hours). Consistent with this action, we are also removing the following forms that were associated with the 2014 package:

CCIP Screen Shots -- Do Study Act Sections Annual Update

CCIP Screen Shots - Act Section Annual Update.jpg

CCIP Screen Shots - Study Section Annual Update

CCIP Screen Shots - Contract Selection Screen Annual Update

CCIP Screen Shots -- Do Section Annual Update

CCIP Screen Shots - Submission Selection Screen Annual Update

QIP Screen Shots - Act Section Annual Update

QIP Screen Shots - Contract Selection Screen Annual Update

QIP Screen Shots - Do Section Annual Update

QIP Screen Shots - Do Study Act Sections Annual Update

QIP Screen Shots - Study Section Annual Update

QIP Screen Shots - Submission Screen Annual Update

MAOs are no longer required to submit CCIP and QIP progress reports to CMS annually. Previously MAOs were required to report project statuses for both the CCIP and QIP. The annual reports required plans to identify problems, analyze results, and document plans on how to fix those problems in the coming years. CMS no longer collects this information. We have transitioned to an annual attestation

Non Rule-Related Changes (New Requirements)

In this information collection request, MAOs would no longer be required to submit CCIP and QIP progress reports to CMS annually. In its place, we have transitioned to an annual attestation requirement. By December 31, 2017, MAOs will be required to attest that they have ongoing CCIPs and QIPs electronically via the Health Plan Management System (HPMS).

The attestation involves no reporting of information or data. Consequently, the attestation requirements and burden are not subject to OMB approval under the PRA.

Additionally, §§422.152(a)(2) and 422.152(c)(2) state that MA plans must report the status and results of each program. CMS will require a few MAOs (no more than 5 annually) to upload information about the results and status of each program (QIP and CCIP) electronically each year. CMS will provide a template that MA plans may use as a reference for their electronic uploads. However, strict adherence to these templates will not be required. Since we estimate fewer than ten respondents, the information collection requirements are exempt from the requirements of the PRA (5 CFR 1320.3(c)).

Likewise, any follow up questions would be subject to the same number of respondents such that they would also be exempt under the same provision of the PRA’s implementing regulations.

Proposed Rule-Related Changes (New Requirement and Burden)

Our proposed rule (CMS-4182-P; RIN 0938-AT08) would remove the QIP attestation requirement (see above for our discussion of non rule-related changes) such that MAOs will only be required to attest that they have an ongoing CCIP.

We believe it is important for CMS to be aware of the clinical focus of the CCIP projects for monitoring purposes. Therefore, the CCIP attestation will require that MA organizations identify what conditions their CCIP projects are focusing on. The requirement that MA organizations identify the clinical focus of their CCIP projects will not be effective until the requirement and burden is approved by OMB under the PRA and the final rule becomes effective.

By adding the revised CCIP attestation requirement, we estimate that it would take 0.25 hours at $67.54/hr for a compliance officer to complete their CCIP attestation electronically. In aggregate, we estimate an annual burden of 187.5 hours (750 MA contracts x 0.25 hr) at a cost of $12,663.75 (187.5 hr x $67.54/hr) or $ 16.89 per MA contract ($12,663.75 / 750 MA contracts).

Attestation Instruments (New)

• CCIP Screen Shot – Attestation Form

Summary of Burden Changes

Time

CY 2014 (Reporting) CY 2017 (Attestation)

	No. Respondents	Time (hours per response)	Annual Burden Hours		No. Respondents	Time (hours per response)	Annual Burden Hours
CCIP	952	15	14,280		750	0.25	187.5
Q1P	952	15	14,280		0	0	0
Total	1,904		28,560		750	0.25	187.5

While the number of respondents has decreased by 1,154 (1,904 – 750), our time estimate has decreased by 28,372.5 hours (28,560 hr - 187.5 hr).

Cost

CY 2014 (Reporting) CY 2017 (Attestation)

	Annual Burden Hours	Wage ($/hr)	Cost ($)		Annual Burden Hours	Wage ($/hr)	Cost ($)
CCIP	14,280	$55	785,400		187.5	67.54	12,663.75
Q1P	14,280	$55	785,400		0	0	0
Total	28,560		1,570,800		187.5		12,663.75

Along with our decreased time estimate (-28,372.5 hr), our wage estimate is now based on BLS data which has been adjusted to account for fringe benefits and overhead. In this regard, our wage figure has increased by $12.54/hr (from $55/hr to $67.54/hr). Overall, our cost estimate has decreased by $1,558,136.25 ($1,570,800 - $12,663.75).

16. Publication/Tabulation Dates

CMS anticipates that there will be no public reports on CCIP and QIP findings.

17. Expiration Date

CMS is not requesting an exemption from displaying the expiration date.

18. Certification Statement

There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

This information collection does not employ any statistical analyses.

1 https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2017/DCB_h.pdf

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