CMS-10472 - Supporting Statement Part A Revised Nav non-Nav clean

Supporting Statement – Part A

Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel

A. Background

On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act. On March 30, 2010, the Health Care and Education Reconciliation Act of 2010 was also signed into law. The two laws collectively are referred to as the Affordable Care Act.

The Affordable Care Act creates Health Insurance Exchanges (Exchanges), new competitive marketplaces where consumers and small businesses can purchase private health insurance. Consumers who access health insurance coverage through Exchanges will be able to receive direct assistance from Navigators authorized to help consumers through the registration, eligibility determination, and plan selection process as they enroll in the Exchanges. Some Exchanges will also provide additional consumer assistance as well as education and outreach.

Section 1311(i)(4) of the Affordable Care Act requires the Secretary to establish standards for Navigators, including provisions to ensure that any entity selected as a Navigator is qualified, and licensed if appropriate, to engage in the Navigator activities required by the law and to avoid conflicts of interest. Final Exchange regulations at 45 CFR 155.205(d) and (e) also require that each Exchange must have a consumer assistance function, and must conduct outreach and education activities to educate consumers about the Exchange and insurance affordability programs to encourage participation. Individuals and entities fulfilling the duties under 45 CFR 155.205(d) and (e) are referred to as non-Navigator assistance personnel.

In order to ensure that any entity selected as a Navigator is qualified to engage in the Navigator activities required by the law and to avoid conflicts of interest, certain disclosures will be necessary. These disclosures were specified in a notice of proposed rulemaking published on April 5, 2013 at 78 FR 20581, codified at 45 CFR 155.210 and 155.215. These disclosures were finalized as part of a final rulemaking published on May 27, 2014 at 79 FR 30240. The disclosures relate to eligibility requirements for Navigators, the mitigation of conflicts of interest, the methods of disclosure of any non-prohibited conflicts of interest, registration prior to training, optional user questionnaire to assess the quality of the training as part of the certification and recertification training, the maintenance of proof of certification or recertification, and the dissemination to consumers of the full range of QHP options and insurance affordability programs for which they may be eligible. These requirements also apply to non-Navigator assistance personnel. These standards are only applicable in Federally-facilitated Exchanges and for federally-funded non-Navigator assistance personnel in State-based Exchanges.

B. Justification

1. Need and Legal Basis

The establishment of Navigator Programs to provide education and outreach to consumers about health insurance exchanges and to provide culturally and linguistically appropriate information in a fair, accurate, and impartial manner among consumers is authorized by Sections 1311(d)(4)(K) and 1311(i) of the Affordable Care Act.

Section 1321(c)(1) of the Affordable Care Act authorizes the Secretary of HHS to “establish and operate” a federal Exchange within any State that does not elect or is not prepared to establish a State-based Exchange, as well as to “take such actions as are necessary to implement” the requirements for establishing an Exchange, including the awarding of Navigator grants.

Section 1311(i)(4) of the Affordable Care Act requires the Secretary to establish standards for Navigators, including provisions to ensure that any entity selected as a Navigator is qualified, and licensed if appropriate, to engage in the Navigator activities required by the law and to avoid conflicts of interest. In addition, Exchanges must provide various forms of consumer assistance in order to fulfill the requirements of 45 CFR 155.205(d) and (e).

2. Information Users

Navigators as well as non-Navigator assistance personnel fulfilling the requirements of 45 CFR 155.205(d) and (e) in Federally-facilitated Exchanges have to provide an attestation to the Exchange that they are not ineligible to serve as a Navigator or non-Navigator assistance personnel. In addition, Navigators and non-Navigator assistance project leads have to prepare and submit a plan for mitigating conflicts of interest during their term as a Navigator grantee or non-Navigator assistance personnel. This mitigation plan is only required on a per entity basis, not a per individual basis. Navigators will include attestation information within their grant application through previously approved OMB covered forms, and as such, the burden for Navigators providing this information is not calculated in this PRA.

Navigators and non-Navigator assistance personnel are required to provide information to eligible consumers about the full range of QHP options and insurance affordability programs for which they may be eligible. A disclosure to the Exchange and each consumer receiving assistance, about certain non-prohibited conflicts of interest, are required by Navigators and non-Navigator assistance personnel.

Prior to performing any Navigator or non-Navigator assistance personnel duties, individuals are required to register for training as a prerequisite to becoming certified. The certification and recertification training will include an optional user questionnaire to assess the quality of the training and any necessary improvements. After their first year performing their required duties, they will be required to be recertified. Navigators and non-Navigator assistance personnel are required to maintain proof of their certification or recertification.

3. Use of Information Technology

All Navigators and non-Navigator assistance personnel will provide conflict of interest disclosures to the Exchange electronically. Disclosures to consumers will be able to be provided orally. Registration, optional user questionnaire, and maintenance of proof of certification or recertification will also be through electronic means. Details on the specific electronic format for submission will be made available to Navigators and non-Navigator assistance personnel as soon as systems are developed.

Government Paperwork Elimination Act (GPEA)

Is this collection currently available for completion electronically?

• No, this will be a new electronic data collection.

Does this collection require a signature from the respondent(s)?

• Navigators and non-Navigator assistance personnel will submit disclosures using the format prescribed by HHS. While they have to identify themselves, there is no requirement for an electronic signature.

If CMS had the capability of accepting electronic signature(s), could this collection be made available electronically?

• Not applicable. The collection will be made electronically. An e-signature will not be required.

If this collection isn’t currently electronic but will be made electronic in the future, please give a date (month & year) as to when this will be available electronically and explain why it can’t be done sooner.

• Not applicable. The collection will be made electronically.

If this collection cannot be made electronic, or if it isn’t cost beneficial to make it electronic, please explain.

• Not applicable. The collection will be made electronically.

4. Duplication of Efforts

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

5. Small Businesses

There are no unique impacts to small businesses involved.

6. Less Frequent Collection

Non-Navigator assistance personnel are only required to provide the required attestation, mitigation plan, and disclosure of certain non-prohibited conflicts of interest to the Exchange one time, unless there is a change which would require the submission of an updated disclosure. Navigators are only required to provide the mitigation plan, disclosure of certain non-prohibited conflicts of interest to the Exchange one time, unless there is a change which would require the submission of an updated disclosure.

Navigators and non-Navigator assistance personnel are required to disclose to consumers receiving assistance information about the full range of QHP options and insurance affordability programs for which they are eligible, as well as certain non-prohibited conflicts of interest. These disclosures are required on a per consumer basis to ensure that each consumer is provided all information as required by statute and regulation.

Navigators and non-Navigator assistance personnel are required to register one time for initial training and certification. Navigators and non-Navigator assistance personnel have the option to complete the training quality questionnaire included in the training; this option will occur on an annual basis. Navigators and non-Navigator assistance personnel are required to maintain proof of their initial certification, and, in subsequent years, proof of their recertification. This recordkeeping requirement is annual in frequency.

7. Special Circumstances

A disclosure of non-prohibited conflicts of interest may need to be reported to the agency more often than quarterly if a Navigator or non-Navigator assistance personnel has a change in the nature of the conflict of interest initially reported, necessitating an updated disclosure.

Navigators and non-Navigator assistance personnel would maintain the proposed disclosures as described for the duration of their term as a Navigator or non-Navigator assistance personnel which may exceed three years.

8. Federal Register/Outside Consultation

A 60-day notice in the Federal Register was published on January 30, 2015 seeking public comments in response to the information collection request described below.¹ No public comments were submitted.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

We do not foresee circumstances that would preclude CMS from consulting with Navigators or non-Navigator assistance personnel.

9. Payments/Gifts to Respondents

Payments and gifts will not be provided.

10. Confidentiality

CCIIO may collect some personally identifiable information related to disclosures of non-prohibited conflicts of interest as well as registration prior to training. To the extent provided by law, we will maintain respondent privacy with respect to the information being collected.

11. Sensitive Questions

In order to perform their required duties, Navigators and non-Navigator assistance personnel may need to communicate with clients about sensitive topics, such as their health status and needs, in order to assist with eligibility determinations and enrollment. As such, requests for some information such as individual or family income, employment status, citizenship, and other characteristics that people might commonly consider private may be communicated.

12. Burden Estimates (Hours & Wages)

Wage per hour data² for Navigator grantee personnel, project leads, and senior level executives; and non-Navigator assistance project leads, personnel, and senior level executives are as follows:

Navigator Personnel – GS-9 equivalent $20

Mid-Level Project Lead – GS-12 equivalent $29

Senior Level Executive – GS-15 equivalent $48

Non-Navigator Assistance Personnel – GS-9 equivalent $20

Non-Navigator Assistance Mid-Level Project Lead- GS 12 equivalent $29

Non-Navigator Senior Level Executive – GS-15 equivalent $48

At this time there are 105 Navigator grantees. We estimate that there are 3,000 individuals working as Navigators. In addition, each grantee organization has one Project Lead and one Senior Level executive. We estimate the number of non-Navigator assistance project leads to be 300 and 1800 for personnel.

Previous estimates have indicated that we expect 4,336,646 applications to be submitted for coverage through the Exchange during the 2013-2014 open enrollment period.³ We estimate about 25 percent of consumers submitting applications for Marketplace coverage will seek assistance from Navigator personnel. In total we estimate that Navigators will assist 1,084,161 individuals during 2014.

Preparing an attestation that an individual or entity is not ineligible to serve as non-Navigator assistance personnel is estimated to have a burden of 0.25 hours (15 minutes) per respondent.

Preparing a conflict of interest mitigation plan is estimated to have a burden of 5 hours per Navigator grantee. The Senior Level Executive is expected to prepare the mitigation plan at a cost of $240 (5 X 48). For 105 grantees the total time burden associated with preparing the mitigation plan is estimated to be 525 hours (5 X 105) at a total cost of $126,000 (240 X 525).

For non-Navigator assistance personnel, preparing a conflict of interest mitigation plan is estimated to have a burden of 5 hours per respondent.

Preparing disclosure to consumers receiving assistance information about the full range of QHP options and insurance affordability programs for which they are eligible, including completion of any necessary forms, is estimated to have a burden of 1 hour per consumer at a cost of $20 (1 X 20). For 1,084,161 consumers the total time burden for this disclosure is estimated to be 1,084,161 hours at a total cost of $21,683,220 (20 X 1,084,161).

Preparing disclosure of non-prohibited conflicts of interest is estimated to have a burden of 0.16 hours (10 minutes) per Navigator personnel at a cost of $3.20 (.16 X 20) For 3,000 Navigator personnel the total time burden associated with preparing this disclosure is estimated to be 480 hours (0.16 X 3,000) at a total cost of $9,600 (20 X 480).

For non-Navigator assistance personnel disclosure of non-prohibited conflicts of interest is estimated to have a burden of 0.16 hours (10 minutes) per respondent.

Registering prior to training is estimated to have a burden of 0.25 hours (15 minutes) per respondent. For a Navigator Senior Level Executive the estimated cost for registration is $12 (0.25 X 48), for Navigator Project Leads the estimated cost is $7.25 (0.25 X 29) and for Navigator personnel the estimated cost is $5 (0.25 X 20). For 105 Senior Level Executives the total time burden associated with registration prior to training is estimated to be 26.25 hours (0.25 X 105) at a total cost of $1,260 (48 X 26.25). For 105 Project Leads the total time burden associated with registration is estimated to be 26.25 hours (0.25 X 105) at a total cost of $761.25 (29 X 26.25). For 3,000 Navigator personnel the total time burden associated with registration is estimated to be 750 hours (0.25 X 3,000) at a total cost of $15,000 (20 X 750).

For non-Navigator assistance personnel, registration prior to training is estimated to have a burden of 0.25 hours (15 minutes) per respondent.

Completion of the optional training quality questionnaire is estimated to have a burden of 0.25 hours (15 minutes) per respondent⁴. While completion of the questionnaire is optional, for the purposes of estimating total time and cost burdens we are assuming all Navigator and non-Navigator assistant personnel staff, Senior Level Executives, and Project Leads will complete the optional questionnaire. For a Navigator Senior Level Executive the cost for the questionnaire completion is $12 (0.25 X 48), for Navigator Project Leads the estimated cost is $7.25 (0.25 X 29) and for Navigator personnel the estimated cost is $5 (0.25 X 20). For 105 Senior Level Executives the total time burden associated with completion of the optional training quality questionnaire is 26.25 hours (0.25 X 105) at a total cost of $1,260 (48 X 26.25). For 105 Project Leads the total time burden associated with completion of the optional training quality questionnaire is estimated to be 26.25 hours (0.25 X 105) at a total cost of $761.25 (29 X 26.25). For 3,000 Navigator personnel the total time burden associated with completion of the training quality questionnaire is estimated to be 750 hours (0.25 X 3,000) at a total cost of $15,000 (20 X 750).

For non-Navigator assistance personnel, completion of the optional training quality questionnaire is estimated to have a burden of 0.25 hours (15 minutes) per respondent.

Maintenance of proof of certification or recertification is estimated to have a burden of 0.016 hours (1 minute) per respondent.⁵ For a Navigator Senior Level Executive the estimated cost for maintenance of proof of certification or recertification is estimated to be $0.77 (0.016 X 48), for Navigator Project Leads the estimated cost is $0.46 (0.016 X 29) and for Navigator personnel the estimated cost is $0.32 (0.016 X 20). For 105 Senior Level Executives total time burden associated with maintenance of proof of certification or recertification is estimated to be 1.68 hours (0.016 X 105) at a total cost of $80.64 (48 X 1.68). For 105 Project Leads the total time burden associated with maintenance of proof is estimated to be 1.68 hours (0.016 X 105) at a total cost of $48.72 (29 X 1.68). For 3,000 Navigator personnel the total time burden associated with maintenance of proof is estimated to be 48 hours (0.016 X 3,000) at a total cost of $960 (20 X 48).

For non-Navigator assistance personnel, maintenance of proof of certification or recertification is estimated to have a burden of 0.016 hours (1 minute) per respondent.⁶

In accordance with 45 CFR 155.210(e)(6) and 45 CFR 155.215(g), Navigators, as well as those non-Navigator personnel to whom 45 CFR 155.215 applies, are required to maintain procedures to inform consumers of the functions and responsibilities of Navigators and non-Navigator assistance personnel (as applicable), and to obtain authorization for the disclosure of consumer information to the Navigator or non-Navigator assistance personnel (as applicable). This is a one-time requirement for the organization.

We estimate that it would take a Navigator or non-Navigator assistance personnel project lead up to 2 hours to create the form for providing authorization to applicants, and a Navigator or non-Navigator senior executive up to 1 hour to review the procedure, for a total time burden of up to 3 hours. We estimate the cost burden associated with creating this procedure would be $106 per organization. The total cost for all 105 Navigator grantee organizations is estimated to be $11,130. The total cost for all 300 non-Navigator assistance personnel organizations is estimated to be $31,800.

There are also recordkeeping requirements associated with developing and maintaining a model agreement and authorization form. Each organization is expected to maintain a copy of the executed forms. We estimate that the time burden associated with maintaining a copy of executed agreement and authorization forms for each consumer would be 0.016 hours (1 minute); we assume these would be maintained through electronic copies with minimal cost.

In addition, there are burdens on individual Navigators, as well as those non-Navigator assistance personnel to whom 45 CFR 155.215 applies. Under 45 CFR 155.210(e)(6) and 155.215(g), respectively, Navigators and non-Navigator assistance personnel are required to inform consumers of the functions and responsibilities of Navigators and non-Navigator assistance personnel and obtain authorization for the disclosure of consumer information to a Navigator or non-Navigator assistance personnel prior to obtaining the consumer’s personally identifiable information⁷.

In the final rule on certified application counselors (78 FR 42824, 42854-42855), we estimated that it would take a certified application counselor 0.25 hours (15 minutes) to provide consumers with information about the functions and responsibilities of a certified application counselor, obtain their authorizations, and provide any applicable conflict of interest disclosures. Because here we are only estimating the time required to provide consumers with information about the functions and responsibilities of a Navigator or non-Navigator assistance personnel and obtain their authorization, we estimate that it would take a Navigator or non-Navigator assistance personnel 0.1667 hours (10 minutes) to perform this task.

The total cost estimate for the consumer authorization process for Navigators and non-Navigator assistance personnel therefore would be $3.33. The total time burden on all 3,000 Navigators is estimated to be approximately 500 hours, and the total cost burden on all 3,000 Navigators is estimated to be $9,990. The total time burden on all 1,800 non-Navigator assistance personnel is estimated to be 300 hours, and the total cost burden on all 1,800 non-Navigator assistance personnel is estimated to be $5,994.

Table 1 - Annual Recordkeeping and Reporting Requirements, By Respondent

Proposed Regulation Section(s)	Number of Respondents	Number of Responses	Burden per Response (hours)	Total Annual Burden (hours)	Hourly Labor Cost of Reporting ($)	Labor Cost of Reporting per Response ($)	Capital/ Maintenance Costs ($)	Total Cost ($)
Conflict of Interest Attestation §155.215(a)(2)(ii) Non-Navigator Assistance Program	-	-	0.25	-	29.20	7.30	0	-
Conflict of Interest Mitigation Plan§155.215(a)(1)(ii) & (a)(2)(iii) Navigator Senior Executive Non-Navigator Assistance Project Lead	105 -	1 -	5 5	525 -	48 29	240 145	0 0	126,000 -
Conflict of Interest Disclosure of Coverage Options § 155.215(a)(1)(iii) & (a)(2)(iv)	3000	361	1	1,084,161	20	20	0	21,683,220
Conflict of Interest Disclosure to Exchange and Consumers § 155.215(a)(1)(iv) & (a)(2)(v) Navigator Personnel Non-Navigator Assistance Personnel	3,000 -	1 -	.16 .16	480 -	20 20	3.20 3.20	0 0	9,600 -
Training Registration §155.215(b)(1)(ii) Navigator Senior Level Executives Navigator Project Leads Navigator Personnel Non-Navigator Assistance Project Lead Non-Navigator Assistance Personnel	105 105 3,000 300 1800	1 1 1 1 1	0.25 0.25 0.25 0.25 0.25	26.25 26.25 750 75 450	48 29 20 29 20	12 7.25 5 7.25 5	0 0 0 0 0	1260 761.25 15,000 2175 9000
Certification and Recertification §155.215(b)(1) –Training Quality Optional User Questionnaire Navigator Senior Level Executives Navigator Project Leads Navigator Personnel Non-Navigator Assistance Project Lead Non-Navigator Assistance Personnel	105 105 3,000 300 1800	1 1 1 1 1	0.25 0.25 0.25 0.25 0.25	26.25 26.25 750 75 450	48 29 20 29 20	12 7.25 5 7.25 5	0 0 0 0 0	1260 761.25 15,000 2175 9000
Certification and Recertification §155.215(b)(1) – Record Maintenance Navigator Senior Level Executives Navigator Project Leads Navigator Personnel Non-Navigator Assistance Project Lead Non-Navigator Assistance Personnel	105 105 3,000 - -	1 1 1 - -	0.016 0.016 0.016 0.016 0.016	1.68 1.68 48 - -	48 29 20 29 20	0.77 0.46 0.32 0.46 0.32	0 0 0 0 0	80.64 48.72 960 - -
Consumer authorization forms (§155.210(e)(6) and §155.215(g) Navigator Senior Level Executives Navigator Project Leads Navigator Personnel Non-Navigator Assistance Senior Level Executives Non-Navigator Assistance Project Lead Non-Navigator Assistance Personnel	105 105 3,000 300 300 1800	1 1 1 1 1 1	1 2 0.1827 1 2 0.1827	1 2 0.1827 1 2 0.1827	48 29 20 48 29 20	48 58 3.654 48 58 3.654	0 0 0 0 0 0	5,040 6,090 10,962 14,400 17,400 6,577.20
Total Navigator Program Non-Navigator Assistance Program	3,210 2400	375 -	19.29	2,664.54 -	827	974.808	0	21,876,043.86 -

13. Capital Costs

There are no capital costs needed for this collection requirement.

14. Cost to Federal Government

I. REVIEW OF DOCUMENTATION SUBMITTED BY NAVIGATOR AWARDEES

It is expected that Navigators will submit a conflict of interest attestation through the grant application process, which is covered under another PRA burden estimate. In addition, Navigators will have to submit a risk mitigation plan and a conflict of interest disclosure to the Federally-facilitated Exchange. In contrast, non-Navigator assistance personnel that are covered by this burden estimate will be operating in Consumer Partnership Marketplaces and as such, will submit any required attestations, risk mitigation plans, and conflict of interest disclosures directly to a state operating in a consumer partnership with CMS.

1. Risk Mitigation Plan and Conflict of Interest Disclosure to Exchange

The risk mitigation plans and non-prohibited conflicts of interest disclosures that a Navigator may have to provide during the course of a grant period will be reviewed and approved by CMS grant project officers, with an estimated wage of $29 per hour.⁸ The time to review each risk mitigation plan and conflict of interest disclosure submission is estimated to be 0.5hours (30 minutes) total.

Hours: 0.5 hours (30 minutes) per submission

Cost: $29 mid-level range x .5 hours (30 minutes) per submission = $14.50 per submission

II. REVIEW OF OPTIONAL TRAINING QUALITY QUESTIONNAIRE RESPONSES SUBMITTED BY NAVIGATOR AND NON-NAVIGATOR ASSISTANCE PERSONNEL

Responses to the optional training quality questionnaire will be reviewed by CMS staff responsible for developing and updating the certification and recertification training, with an estimated wage of $29 per hour. ⁹ The time to review each completed questionnaire is estimated to be 0.25 hours (15 minutes total).

Hours: 0.25 hours (15 minutes) per submission

Cost: $29 mid-level range x .25 hours (15 minutes) per submission = $7.25 per submission

15. Changes to Burden

These collection requirements are associated with 45 CFR 155.210 and 155.215. These requirements were finalized as part of a final rulemaking published on May 27, 2014 at 79 FR 30240. No changes are being made to currently approved collection requirements. The revision to this collection is due to the addition of an optional training quality questionnaire at the end of the required initial certification, and annual recertification, trainings.

16. Publication/Tabulation Dates

At this time, HHS does not expect that the data collected in the quarterly and annual reports will be published or shared with other agencies.

17. Expiration Date

This collection does not lend itself to the displaying of an expiration date.

1 See 80 FR 5118.

2 Wage data from OPM GS Wage Tables at http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2013/general-schedule/gs_h.pdf.

3 See Supporting Statement for Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Affordable Insurance Exchanges, Medicaid and Children’s Health Insurance Program Agencies, available at http://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-10440.html.

4 See Appendix F, “Training Quality Questionnaire,” for screen shots of the optional training quality questionnaire.

5 See Appendix A for screen shots of the registration portal; see Appendices B and C for a sample training completion and certification certificate..

6 See Appendix A for screen shots of the registration portal; see Appendices B and C for a sample training completion and certification certificate.

7 See Appendices D and E for a model authorization, in English and Spanish, which Navigators and non-Navigator assistance personnel may use to fulfill this requirement..

8 Wage data from OPM GS Wage Tables at http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2012/general-schedule/gs_h.pdf.

9 Wage data from OPM GS Wage Tables at http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2012/general-schedule/gs_h.pdf.

9