Contraceptive SS 1210-0150 9-4-24 (clean)

Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector

OMB Control Number 1210-0150

Expiration Date: 11/30/2024

SUPPORTING STATEMENT FOR PAPERWORK REDUCTION ACT OF 1995 SUBMISSIONS FOR COVERAGE OF CERTAIN PREVENTIVE SERVICES UNDER THE AFFORDABLE CARE ACT—PRIVATE SECTOR

This information collection request (ICR) seeks approval for an extension without change of an existing control number.

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

An entity seeking to be treated as an eligible organization¹ may self-certify (by using EBSA Form 700), prior to the beginning of the first plan year to which an optional accommodation is to apply, that it meets the definition of an eligible organization.² The self-certification must be executed by an authorized representative of the organization. The self-certification will not be submitted to any of the Departments. The organization must maintain the self-certification in its records in a manner consistent with ERISA section 107 and make it available for examination upon request. The eligible organization must provide a copy of its self-certification to each health insurance issuer that would otherwise provide such coverage in connection with the health plan (for insured group health plans or student health insurance coverage). The issuer that receives the self-certification must provide for separate payments for contraceptive services for plan participants and beneficiaries (or students and dependents). For a self-insured group health plan, the self-certification must be provided to the plan’s third-party administrator.

A health insurance issuer or third-party administrator providing or arranging payments for contraceptive services for participants and beneficiaries in plans (or for student enrollees and covered dependents in student health insurance coverage) of eligible organizations must provide a written notice to such plan participants and beneficiaries (or such student enrollees and covered dependents) informing them of the availability of such payments. The notice must be provided contemporaneous with (to the extent possible) but separate from any application materials distributed in connection with enrollment (or re-enrollment) in group or student health coverage that is effective on the first day of each applicable plan year, and must specify that contraceptive coverage will not be funded or administered by the eligible organization but that the issuer or third party administrator, as applicable, will separately arrange or provide payments for contraceptive services. The notice must also provide contact information for the issuer or third-party administrator for questions and complaints. To satisfy the notice requirement, issuers and third-party administrators may use the model language set forth in the 2013 final regulations or substantially similar language.

To the extent provided under the applicable regulations governing the optional accommodation, eligible organizations can revoke at any time the accommodation if participants and beneficiaries are provided written notice of such revocation by the issuer or third party administrator in accordance with guidance issued by the Secretary, and such revocation will be effective on the first day of the first plan year that begins on or after thirty days after the date of revocation.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The requirement to provide a self-certification or notice to HHS, insurer, or a third-party administrator is an optional third-party reporting disclosure. These disclosures are optional to exempt eligible organizations from contracting, arranging, paying, or referring for contraceptive coverage, but do make it possible for participants in plans to receive coverage for services from which employers sought the exemption. Eligible organizations using the accommodation must maintain the self-certification or notice to HHS in a manner consistent with the record retention requirements under section 107 of the Employee Retirement Income Security Act of 1974, which generally requires records to be maintained for six years. The notices sent by issuers and third-party administrators will inform plan participants and beneficiaries (or student enrollees and covered dependents) of the availability of such payments.

Employers that under the previous rules had used the accommodation process, but can now be exempt may now choose to revoke their use of the accommodation process, but in order to do so they must provide participants and beneficiaries written notice of such revocation as soon as possible, so participants and beneficiaries will know their benefit coverage.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration for using information technology to reduce burden.

The regulations do not limit the ability of affected eligible organizations to furnish the self-certification or notice to HHS via electronic media.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

The information collection does not require duplicative information.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The eligible organization only has to complete the self-certification or notice to HHS one time, unless there is a change in its qualifications as an eligible organization, religious objection, health insurance issuer, or third-party administrator.

If completing the EBSA Form 700, the eligible organization may maintain the self-certification in its own records after it is provided to issuers or third-party administrators (as outlined in the final regulations), and is not required to submit it to the government. If providing notice to HHS, the eligible organization may maintain the notice in its own records after it is provided to the government. The eligible organization may provide the self-certification electronically to further reduce burden.

For eligible organizations that provide notice to HHS, the Departments are providing model language that can be used to satisfy the notice requirement to minimize burden.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

While the notice is optional, if eligible organizations do not provide the self-certification to issuers and third-party administrators or notice to HHS, issuers and third-party administrators will not be able to make or arrange for separate payments for contraceptive services. If issuers and third-party administrators do not send notices to enrollees, plan participants and beneficiaries (or student enrollees and covered dependents) will not have access to separate payments for contraceptive services without cost sharing.

If the accommodation is revoked, participants need to receive the notice of revocation to know their coverage options.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

• requiring respondents to report information to the agency more often than quarterly;

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

• requiring respondents to submit more than an original and two copies of any document;

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

• 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;

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

• that includes 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

• requiring 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.

The regulations require the self-certification or notice to HHS to be maintained in a manner consistent with the record retention requirements under section 107 of the Employee Retirement Income Security Act of 1974, which generally requires records to be kept for six years.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and record keeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

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.

The Department’s Federal Register notice required by 5 CFR 1320.8(d) providing the public with 60 days to comment was published in the Federal Register on February 5, 2024 (89 FR 7732). The public was provided with 60 days to comment on the submission, and no comments were received.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

There are no payments or gifts in this information collection.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

There are no questions of sensitive nature in this information collection, and thus there is no assurance of confidentiality provided to respondents.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

There is no assurance of confidentiality attached to this information collection.

12. Provide estimates of the hour burden of the collection of information. The statement should:

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

• If this request for approval covers more than one form, provide separate hour burden estimates for each form.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item 14.

• The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item 14.

The Department is not able to estimate how many organizations would utilize this optional accommodation process or take advantage of exempt status. It was observed in the August 2014 interim final rules that there were 122 eligible entities that had filed litigation against the accommodation process, and in the July 2015 final regulations it was estimated that there were 87 closely held for-profit entities that would seek the accommodation for a total of 209 entities (79 FR 51096; 80 FR 41336). Under the exemptions and optional accommodation process in these interim final rules, the Department anticipates that all of the entities that have brought litigation against the accommodation process will not opt into it, but will make use of their exempt status, and that most for-profit entities (which had brought a similar round of lawsuits against the Department before the accommodation process was expanded to include them) will also not make use of the optional accommodation process. But, because the exemption is expanded, it is anticipated that some newly exempt entities might make use of the accommodation process. The Department estimates that in total far fewer entities will opt into the accommodation process than have brought litigation against it or have used it while litigation over the accommodation was pending. For the purposes of this calculation, therefore, it is estimated that no more than 100 entities will opt into the accommodation process and 109 entities will revoke their use of the process as exempt entities. It is assumed that an additional nine entities will use the expanded accommodation process for a total of 109 entities using the accommodation process and 109 entities that will revoke their use of the accommodation process. It is also estimated that there will be no morally objecting firms that will elect to use the accommodation process; instead they will use claim exempt status. Therefore, no burden is attributed to these entities.

The Department estimates that 2,376,000 plan participants and beneficiaries will be covered in the plans of the 100 entities that previously used the accommodation and will continue doing so, and that an additional nine entities will newly opt into the accommodation. We estimated that the 100 entities that previously used the accommodation and will continue doing so will cover approximately 75 percent of the persons in all accommodated plans, based on HHS data concerning accommodated self-insured plans that indicates plans sponsored by religious hospitals and health systems encompass more than 80 percent of the persons covered in such plans. In other words, plans sponsored by such entities have a proportionately larger number of covered persons than do plans sponsored by other accommodated entities, which have smaller numbers of covered persons. As noted above, many religious hospitals and health systems have indicated that they do not object to the accommodation, and some of those entities might also qualify as self-insured church plans. The Department does not have specific data on which plans of which employer sizes will actually continue to opt into the accommodation, nor how many will make use of self-insured church plan status. The Department assumes that the proportions of covered persons in self-insured plans using contraceptive user fees adjustments also apply in fully insured plans, for which we lack representative data.

For the purpose of this analysis, the Department will use the following wage rates of $180.68 for compensation and benefit manager, $177.97 for legal counsel, $69.41 for clerical staff, $141.63 for general and operations manager, and $147.07 for senior executive.³

A. ICRs Regarding Self-Certification or Notices to HHS (§147.131(c)(3))

Each organization seeking to be treated as an eligible organization to use the optional accommodation process offered under these interim final regulations must either use the EBSA Form 700 method of self-certification or provide notice to HHS of its religious or moral objection to coverage of all or a subset of contraceptive services. Specifically, these final regulations continue to allow eligible organizations to notify an issuer or third-party administrator using EBSA Form 700, or to notify HHS of its religious or moral objection to coverage of all or a subset of contraceptive services, as set forth in the July 2015 final regulations.

In order to estimate the cost for an entity that chooses to opt into the accommodation process, it is assumed, as it was in its August 2014 interim final rules, that clerical staff for each eligible organization will gather and enter the necessary information and send the self-certification to the issuer or third-party administrator as appropriate, or send the notice to HHS.⁴ It is assumed that a compensation and benefits manager and inside legal counsel will review the self-certification or notice to HHS and a senior executive would execute it. It is estimated that an eligible organization would spend approximately 50 minutes (30 minutes of clerical staff, 10 minutes for a compensation and benefits manager, 5 minutes for legal counsel, and 5 minutes by a senior executive) in preparing and sending the self-certification or notice to HHS and filing it to meet the recordkeeping requirement. See Table 1 for calculation and burden totals.

Table 1. Burden for Self-Certification or Notice to HHS

	Number of Entities	Number of Hours per Entity	Total Hour Burden	Wage Rate	Equivalent Cost of Hour Burden
	(A)	(B)	(A × B)	(C)	(A × B × C)
Benefit manager prepares self-certification or notice to HHS	9	0.17	1.5	$180.68	$271
Legal counsel prepares self-certification or Notice to HHS	9	0.08	0.75	$177.97	$133
Clerical staff prepares self- certification or notice to HHS	9	0.50	4.5	$69.41	$312
Senior Executive prepares self-certification or Notice to HHS	9	0.08	0.75	$147.07	$110
Total	4.5	-	7.5	-	$827

B. ICRs Regarding Notice of Availability of Separate Payments for Contraceptive Services (§147.131(e))

As required by the July 2015 final regulations, a health insurance issuer or third-party administrator providing or arranging separate payments for contraceptive services for participants and beneficiaries in insured plans (or student enrollees and covered dependents in student health insurance coverage) of eligible organizations is required to provide a written notice to plan participants and beneficiaries (or student enrollees and covered dependents) informing them of the availability of such payments. The notice must be separate from but contemporaneous with (to the extent possible) any application materials distributed in connection with enrollment (or re-enrollment) in group or student coverage of the eligible organization in any plan year to which the accommodation is to apply and will be provided annually. To satisfy the notice requirement, issuers may, but are not required to, use the model language set forth previously or substantially similar language.

It is anticipated that approximately 109 entities will seek the optional accommodation (100 that used it previously, and 9 that will newly opt into it). It is unknown how many issuers or third-party administrators provide health insurance coverage or services in connection with health plans of eligible organizations, but it is assumed at least 109. It is estimated that each issuer or third-party administrator will need approximately 1 hour of clerical staff and 15 minutes of general and operations manager to prepare the notices. See Table 2 for calculations and burden totals.

Table 2. Burden for Notice of Availability of Separate Payments for Contraceptive Services

	Number of Entities	Number of Hours per Entity	Total Hour Burden	Wage Rate	Equivalent Cost of Hour Burden
	(A)	(B)	(A × B)	(C)	(A × B × C)
Clerical staff prepares Notice of Availability of Separate Payments for Contraceptive Services	109	1	109	$69.41	$7,566
General and operations manager prepares Notice of Availability of Separate Payments for Contraceptive Services	109	0.25	27.25	$141.63	$3,859
Total	109	-	136	-	$11,425

C. ICRs Regarding Notice of Revocation of Accommodation (§147.131(c)(4))

If the accommodation rules in effect so provide, an eligible organization may revoke its use of the accommodation process and its issuer or third-party administrator must provide written notice of such revocation to participants and beneficiaries as specified in guidance issued by the Secretary. The Departments expect that entities that wished to do so have already sent the notice, and that no additional entities will avail themselves of, and subsequently revoke, use of the accommodation process. Therefore, no new entities are expected to incur this cost in the future.

D. Summary

In summary, the total hour burden for this information collection is 144 hours with an equivalent cost of $12,252. As the Department of Labor and the Department of Health and Human Services share jurisdiction, they are splitting the hour burden. Therefore, for DOL, the total hour burden for this information collection is 72 hours with an equivalent cost of $6,127.

Table 3. Estimated Annualized Respondent Cost and Hour Burden

	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden (Hours)	Total Burden (Hours)	Wage Rates	Equivalent Cost
Benefit manager prepares self-certification or notice to HHS	9	1	9	0.17	1.5	$180.68	$271
Legal counsel prepares self-certification or Notice to HHS	9	1	9	0.08	0.75	$177.97	$133
Clerical staff prepares self- certification or notice to HHS	9	1	9	0.50	4.5	$69.41	$312
Senior Executive prepares self-certification or Notice to HHS	9	1	9	0.08	0.75	$147.07	$110
Clerical staff prepares Notice of Availability of Separate Payments for Contraceptive Services	109	1	109	1	109	$69.41	$7,566
General and operations manager prepares Notice of Availability of Separate Payments for Contraceptive Services	109	1	109	0.25	27	$141.63	$3,859
Total	118	-	1,190,622	-	144	-	$12,252
Total (DOL)*	60*	-	595,312**	-	72	-	$6,127

Note:

* As the Department of Labor and the Department of Health and Human Services share jurisdiction, they are splitting the hour burden.

**The total number of respondents is calculated in the following manner: 5 (Self-Certification or Notice to HHS) + 55 (Notice of Availability of Separate Payments for Contraceptive Services) = 60

***The total number of responses is calculated in the following manner: 5 (Self-Certification or Notice to HHS) + 595,307 (Notice of Availability of Separate Payments for Contraceptive Services) = 595,312.

12. Provide an estimate of the total annual cost burden to respondents or record-keepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12.)

• The cost estimate should be split into two components: (a) a total capital and start up cost component (annualized over its expected useful life); and (b) a total operation and maintenance and purchase of service component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities. 

• If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate. 

• Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices. 

A. ICRs Regarding Self-Certification or Notices to HHS (§147.131(c)(3))

DOL estimates that each self-certification or notice to HHS will require $0.68 in postage⁵ and $0.05 in materials cost (paper and ink) and the total postage and materials cost for each self-certification or notice sent via mail will be $0.73. For purposes of this analysis, DOL assumes that 58.3 percent of self-certifications or notices to HHS will be sent electronically, and remaining 41.7 percent notices will be mailed.⁶ See Table 4 for calculation and burden totals.

Table 4. Materials and Mailing Cost Burden

	Number of Entities	Mailing Cost per Entity	Cost Burden
	(A)	(B)	(A × B)
Self-certification or Notice to HHS	9	$0.73	$7
Notice of Availability of Separate Payments for Contraceptive Services	496,486	$0.73	$362,435
Total	496,495	-	$362,442

B. ICRs Regarding Notice of Availability of Separate Payments for Contraceptive

As discussed at the start of question 12 for the 109 entities, the total number of persons needing notices will be 1,190,613. For purposes of this analysis, the Departments also assume that 58.3 percent of notices will be sent electronically, and remaining notices will be mailed. DOL estimates that each notice will require $0.68 in postage and $0.05 in materials cost (paper and ink) and the total postage and materials cost for each notice sent via mail will be $0.73. See Table 4 for the calculation of material, printing, and mailing cost burdens.

C. ICRs Regarding Notice of Revocation of Accommodation (§147.131(c)(4))

If the accommodation rules in effect so provide, an eligible organization may revoke its use of the accommodation process and its issuer or third-party administrator must provide written notice of such revocation to participants and beneficiaries as specified in guidance issued by the Secretary. The Departments expect that entities that wished to do so have already sent the notice, and that no additional entities will avail themselves of, and subsequently revoke, use of the accommodation process. Therefore, no new entities are expected to incur this cost in the future.

D. Summary

In summary, the total cost burden for this information collection is $362,442. As the Department of Labor and the Department of Health and Human Services share jurisdiction, they are splitting the cost burden so each will account for half of the materials and postage cost burden. For DOL, the total cost burden for this information collection is $181,222.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13, and 14 in a single table.

There are no costs to the Federal government associated with this information collection. There is no information provided to DOL.

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14.

This ICR has updated data on the labor costs, mailing costs, and the number of plan participants and beneficiaries. The Department has also updated the percent of notices that will be delivered electronically. Finally, this ICR has not included burden for the Notice of Revocation of Accommodation in the burden estimation as the Departments expect that entities that wished to do so have already sent the notice. As a result, the number of total responses has decreased by 182,051 responses, and the hour burden has decreased by 109 hours, and the cost burden has decreased by $13,741.

16. For collections of information whose results will be published, outline plans for tabulation, and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

There are no plans to publish the results of this collection of information.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

This information collection will display the expiration date for OMB approval.

18. Explain each exception to the certification statement identified in Item 19.

There are no exceptions to the certification statement identified in Item 19.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

This information collection does not employ statistical methods.

1 For the definition of “eligible organization” with respect to the optional accommodation, see 26 CFR 54.9815-2713A(a), 29 CFR 2590.715-2713A(a), and 45 CFR 147.131(c).

2 An eligible organization may submit a notification to HHS as an alternative to submitting the EBSA Form 700 to the eligible organization’s health insurance issuer or third-party administrator. In addition, pursuant to the Departments’ 2017 interim final rules and the 2018 final rules, the accommodation compliance process for eligible organizations is optional (instead of mandatory).

3 Internal DOL calculation based on 2024 labor cost data. For a description of DOL’s methodology for calculating wage rates, see https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf.

4 For purposes of this analysis, the Department assumes that the same amount of time will be required to prepare the self-certification and the notice to HHS.

5 https://www.usps.com/business/prices.htm

6 According to data from the National Telecommunications and Information Agency (NTIA), 37.4 percent of individuals age 25 and over have access to the internet at work. According to a Greenwald & Associates survey, 84 percent of plan participants find it acceptable to make electronic delivery the default option, which is used as the proxy for the number of participants who will not opt out of electronic disclosure that are automatically enrolled (for a total of 31.4 percent receiving electronic disclosure at work). Additionally, the NTIA reports that 44.1 percent of individuals age 25 and over have access to the internet outside of work. According to a Pew Research Center survey, 61.0 percent of internet users use online banking, which is used as the proxy for the number of internet users who will affirmatively consent to receiving electronic disclosures (for a total of 26.9 percent receiving electronic disclosure outside of work). Combining the 31.4 percent who will receive electronic disclosure at work with the 26.9 percent who will receive electronic disclosure outside of work produces a total of 58.3 percent who will receive electronic disclosure overall.

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