1210-0144 DOL IFR 2 external review SS 3.20.25

Affordable Care Act Internal Claims and Appeals and External Review Procedures for ERISA Plans

OMB Control Number: 1210-0144

Expiration Date: 05/30/2025

SUPPORTING STATEMENT FOR PAPERWORK REDUCTION ACT 1995: AFFORDABLE CARE ACT INTERNAL CLAIMS AND APPEALS AND

EXTERNAL REVIEW PROCEDURES FOR ERISA PLANS

This ICR seeks approval for an extension of an existing control number.

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.

The Patient Protection and Affordable Care Act, Public Law 111-148, (the Affordable Care Act) was enacted on March 23, 2010. The Affordable Care Act reorganized, amended, and added to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. This ICR focuses on the addition of section 2719 to the PHS act, which provides rules relating to internal claims and appeals and external review processes. The Department of the Treasury, Department of Labor (DOL), and the Department of Health and Human Services (the Departments) issued final regulations (80 FR 72192) implementing section 2719 of the PHS Act.

PHS Act section 2719 and 29 CFR 2590.715-2719(b)(2)(i) of the final regulations provide that group health plans and health insurance issuers offering group health insurance coverage must comply with the internal claims and appeals processes set forth in 29 CFR 2560.503-1 (the DOL claims procedure regulation) and update such processes in accordance with standards established by the Secretary of Labor in paragraph (b)(2)(ii) of the final regulations.

The DOL claims procedure regulation requires plans to provide every claimant who is denied a claim with a written or electronic notice that contains the specific reasons for denial, a reference to the relevant plan provisions on which the denial is based, a description of any additional information necessary to perfect the claim, and a description of steps to be taken if the participant or beneficiary wishes to appeal the denial. The regulation also requires that any adverse benefit determination upon review be in writing (including electronic means) and include specific reasons for the decision, as well as references to relevant plan provisions.

Additionally, 29 CFR 2590.715-2719(b)(2)(ii)(C) of the final regulations adds a requirement that non-grandfathered ERISA-covered group health plans provide to the claimant, free of charge, any new or additional evidence considered, relied upon, or generated by the plan or issuer in connection with the claim.¹

Also, PHS Act section 2719 and the final regulations require group health plans and issuers offering group health insurance coverage to comply either with a State external review process or a Federal review process. The regulations provide a basis for determining when plans and issuers must comply with an applicable State external review process and when they must comply with the Federal external review process.

The No Surprises Act extends the balance billing protection related to external reviews to grandfathered plans. The definitions of group health plan and health insurance issuer that are cited in section 110 of the No Surprises Act include both grandfathered and non-grandfathered plans and coverage. Accordingly, the practical effect of section 110 of the No Surprises Act is that grandfathered health plans must provide external review for adverse benefit determinations involving benefits subject to these surprise billing protections.

The claims procedure regulation imposes information collection requirements as part of the reasonable procedures that an employee benefit plan must establish regarding the handling of a benefit claim. These requirements include third-party notice and disclosure requirements that the plan must satisfy by providing information to participants and beneficiaries of the plan.

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 ICRs included in the claims procedure regulation ensure that participants and beneficiaries (claimants) receive adequate information regarding the plan’s claims procedures and the plan’s handling of specific benefit claims. Participants and beneficiaries need to understand plan procedures and plan decisions in order to appropriately request benefits and/or appeal benefit denials.

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 claims regulation does not restrict plans’ use of electronic technology to process and pay claims, to maintain information as to the basis for claim determination, and to generate correspondence related to claims processing decisions. This DOL claims procedure regulation also incorporates, by reference, pertinent provisions of DOL’s separate regulation, 29 CFR 2520.104b‑1, facilitating and encouraging the use of electronic information technology.

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.

No duplication with other Federal statutes exists. In some circumstances, states may require substantially similar information to be provided to insured persons. However, no duplication occurs because the same information disclosure may be used to satisfy duplicative or overlapping requirements.

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

The regulation applies to all employee benefit plans and therefore is likely to affect small entities (small businesses and small plans) that provide benefits. The Departments considered the potential burden on small entities in structuring the regulations by permitting plan sponsors the maximum possible flexibility in designing their plans.

For instance, plan sponsors are allowed to hire third-party service providers to carry out these administration responsibilities, letting them use the lowest cost method of compliance available. A majority of small plans purchase claims administration services from insurers, health maintenance organizations (HMOs), and other service providers. The Departments have taken this fact into account in deriving burden estimates. These service providers typically develop a single claims processing system to service a large number of customers, including small entities. Thus, the infrastructure cost for this information collection is spread thinly over a large number of small plans. Moreover, small plans and their respective enrollees benefit equally from the service provider’s expertise and ability to provide improved accuracy and timeliness in claims and appeals determinations.

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.

The ICRs arise when individual claims for benefits occur and consist of third-party notices and disclosures. No information is reported to the Federal government. Every claim event is normally of importance to the specific participant who relies on an employee benefit plan to provide the promised benefit. The information collection provisions of the regulation ensure that sufficient information is provided to:

1. participants and beneficiaries so that they may fully exercise their rights under their employee benefit plans, and

2. fiduciaries responsible for operating plans in accordance with their terms.

If this collection is not conducted or is conducted less frequently, participants and beneficiaries will not have the information necessary to fully exercise their rights and plan fiduciaries will not be able to responsibly operate their plans.

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 DOL claims procedure regulation imposes special timing requirements for the handling of claims under group health plans. Depending on circumstances indicating the urgency of the need for a claims decision, group health plans may be required to notify claimants about health benefit claim determinations in fewer than 30 days.

First, for claims involving “urgent care,” the regulation requires, in general, that claimants be notified of health benefit determinations “as soon as possible, taking into account the medical exigencies, but not later than 72 hours after receipt of the claim by the plan [...]”.² In cases involving urgent care where the health claim is a request to extend the time period or number of treatments of ongoing medical care (referred to as “concurrent care decisions”), this period is 24 hours.³

Second, for “pre-service” claims, the regulation requires that claimants be notified of health benefit determinations “within a reasonable period of time appropriate to the medical circumstances, but not later than 15 days after receipt of the claim by the plan.”⁴ Pre-service claims involve plan requirements that a claimant obtain approval from the plan prior to receiving health care services or products in order to maintain eligibility for benefits.

Third, for “post-service” health benefit claims, the regulation requires notification of an adverse benefit determination “within a reasonable period of time, but not later than 30 days after receipt of the claim.”⁵ Even though 30 days is the maximum response time for these claims, a plan must provide a determination sooner if it is reasonable to do so. Disability benefit claims are subject to a similar construct, except that the maximum response time is 45 days.⁶

Appeals of denied claims must be decided within similar, short time limits.

These timing requirements are reasonably related to important policy objectives in an area of important public concern. For example, the shortest time frame for “urgent care” claims applies only under circumstances in which delay could seriously jeopardize the life or health of the claimant or the ability of the claimant to regain maximum function, or where delay would subject the claimant to severe pain. The next shortest time frame applies under circumstances in which medical care, while not urgent, has not been provided to a claimant who needs treatment for a medical problem and where the plan itself requires pre-approval of the medical care before providing coverage. Post-service health claims and disability claims also involve important concerns relating to the sick and disabled, but under these circumstances plans may take at least 30 days to respond if it is reasonably necessary to do so.

Another reason why these time frames are important is that these notices relate to the payment of money by a plan to claimants to whom fiduciary responsibilities are owed. Without enforcement of reasonable deadlines, payors could be given a financial incentive to delay the payments, and this would likely be inconsistent with appropriate fiduciary standards.

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 recordkeeping, 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 notice required by 5 CFR 1320.8(d), which provided the public with 60 days to comment on the information collection, was published in the Federal Register on July 9, 2024 (89 FR 56416). No comments were provided on this ICR.

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

DOL makes no payments to respondents.

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

ICR involves disclosures of information by plan administrators to plan participants. Issues of confidentiality between third parties do not fall within the scope of this information collection request.

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.

A plan provides information directly to the claimant. Sensitive issues, such as health information, would relate to the claim for which payment is sought, and the initial filing would have been initiated by the claimant or with the claimant’s authorization.

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.

Because ERISA-covered plans already are required to comply with the DOL claims procedure regulation (OMB Control number 1210-0053), the Departments did not attribute any cost for these plans to comply with that information collection. As stated above, paragraph (b)(2)(ii) provides additional standards non-grandfathered ERISA-covered plans must meet. The requirement to provide claimants, free of charge, any new or additional evidence considered relied upon, or generated by the plan or issuer in connection with the claim,⁷ and the requirement to comply either with a State external review process or a Federal review process increases the hour and cost burden imposed on plans and issuers to prepare and deliver the additional information to the claimant.

The burden associated with the additional standards that non-grandfathered and grandfathered ERISA-covered plans must meet is shared equally between DOL and the Department of the Treasury. The burden discussion below encompasses the combined burden of both agencies. A summary at the end describes the share of the burden allocated to DOL.

Ongoing burdens are a function of the number of external appeals filed as well as those requiring a fair and full review, which are in turn a function of health claims volume, as well as the denial and appeal rates.

Wage Rate Determinations

The Departments estimate that several types of personnel will perform the tasks associated with information collection requests at an hourly wage rate of $69.41 for clerical personnel, $208.88 for a physician, $177.97 for a legal professional, $100.21 for a human resource specialist, and $64.46 for a medical secretary.⁸

Claims and Appeals

Table 1 below describes the affected participants and relevant data necessary to estimate the burden associated with claims and appeals.

Table. 1—Annual Estimated Claims and Appeals in Private Sector ESI

(A)	Total Enrollees			135,600,000
(B)	Non-Grandfathered Enrollees			116,616,000
(C)	Affected Participants			90,100,000
(D)	Self-Insured Plan Participants			78,900,000
(E)	Fully-Insured Grandfathered Plan Participants			11,200,000
(F)	Out-of-Network Claims Increase			2%
(G)	Appeal-to-Member Ratio			0.00013
(H)	Eligibility Rate for External Appeal			0.75
(I)	Medical Appeals			120,316
(J)	Administrative Appeals			296,003
(K)	Claims w/ Additional Evidence			70%
((I) + (J)) x (K)	Fair and Full Reviews			291,423
(C x F x G)	External Appeals			11,956
(C x F x G) ÷ (H)	External Appeals Submitted			15,941

Note: Data on participants and enrollees originates from U.S. Department of Labor, EBSA Abstract of Auxiliary Data for the March 2023 Annual Social and Economic Supplement to the Current Population Survey.

The transaction burden will vary widely with the type and complexity of claim in question, but the mix of claims and associated burdens generally are expected to be similar across plans of the same type. The average time required for this information collection associated with any particular type of health benefit claim transaction will range from five minutes for a medical secretary to produce a notice for a fair and full review to as many as 20 minutes for a physician to draft a response to an appeal brought before an external, independent review organization. Detailed calculations of the hour burden are provided in Table 2 below.

Table 2. -- Hour Burden and Equivalent Cost for Claims and Appeals
Description	Entities	Hours per Entity	Wage Rate	Hour Burden	Cost Equivalent
	(A)	(B)	(C)	(A x B)	(A x B x C)
Medical Secretary Produces Fair and Full Review Notice	291,423	5/60	$64.46	24,285.3	$1,565,427.22
Physician Drafts Appeal Response	11,956	20/60	$208.88	3985.3	$832,456.43
Three-Year Total…..........................	910,137	-	-	84,812	$7,193,651
Annual Average…….......................	303,379	-	-	28,271	$2,397,884
*The annual average cost is calculated as the total cost averaged across three years of the rule

The three-year average burden hours for claims and appeals are estimated at 28,271 hours annually at an equivalent cost of $2,397,884.

Federal External Review

The disclosure requirements of the Federal external review process require:

1. a preliminary review by plans of requests for external appeals;

2. Independent Review Organizations (IROs) to notify claimants of eligibility and acceptance for external review;

3. the plan or issuer to provide IROs with documentation and other information considered in making the adverse benefit determination;

4. the IRO to forward to the plan or issuer any information submitted by the claimant;

5. the plan to notify the claimant and IRO if it reverses its decision;

6. the IRO to notify the claimant and plan of the result of the final external appeal (burden previously accounted for);

7. the IRO to maintain records for six years.

The Departments estimate that there are approximately 78.9 million participants in self-insured ERISA-covered plans.⁹ In the States which currently have no external review laws or whose laws do not meet the federal minimum requirements,¹⁰ the Departments estimate that there are approximately 17.2 million participants in ERISA-covered plans. Additionally, 11.2 million participants in grandfathered plans will be required to be covered by the external review requirement. Accordingly, these estimates lead to a total of 90.1 million participants that would be affected by the external review requirements.

The Departments estimate that there are 1.3 external appeals for every 10,000 participants.¹¹ Additionally, as stated in Table 1, the Departments estimate that there will be approximately 11,956 external appeals annually. Experience from North Carolina indicates that about 75 percent of requests for external appeals are actually eligible to proceed to an external review,¹² therefore it is expected that there will be about 15,941 (11,956 ÷ 0.75) requests for appeals.

The Departments estimate that a human resource specialist will spend approximately 15 minutes for each preliminary external request.¹³ Plans will already have conducted internal reviews for eligible claimants; therefore, the required information for plans to make this determination should be readily available. Detailed calculations of the hour burden are provided in Table 3 below.

IROs must also send each eligible claimant a notice of eligibility and acceptance. The Departments assume that a clerical professional at the IRO will spend on average five minutes per claimant preparing the notice.

IROs are required to send to plans all documents that claimants submit. The Departments do not know what fraction of claimants will submit additional documentation, but for purposes of this burden analysis assume that half of claimants (5,978) do. The Departments assume that a clerical professional for the IRO will spend on average five minutes per claimant preparing and forwarding the required documents. Detailed calculations of the hour burden are provided in Table 3 below.

Once an eligibility determination is made, plans must provide the IRO with all documentation and other information considered in making an adverse benefit determination. The Departments assume that a clerical professional for plans will spend an average of five minutes in order to send documentation to the IRO for each request. Detailed calculations of the hour burden and cost are provided in Table 3 below.

IROs are required to notify the claimant and plan of the result of the final external appeal. The Departments estimate that preparing and sending the notices for each of the external reviews will take a clerical professional at the IRO on average five minutes per claimant. Detailed calculations of the hour burden are provided in Table 3 below.

IROs also are required to maintain records of all claims and notices associated with the external review process for six years. The Departments believe that these documents will be retained as a customary part of business but estimate that a clerical professional will spend an additional five minutes per claimant ensuring all files are complete. Detailed calculations of the hour burden are provided in Table 3 below.

Table 3. -- Hour Burden and Equivalent Cost for External Appeals Requests
Description	Entities	Hours per Entity	Wage Rate	Hour Burden	Cost Equivalent
	(A)	(B)	(C)	(A x B)	(A x B x C)
Human Resource Specialist Reviews Appeal Requests	15,941	15/60	$100.21	3,985.3	$399,361.90
Clerical Professional Notifies Claimant of Appeal Acceptance	11,956	5/60	$69.41	996.3	$69,155.50
Clerical Professional Sends Plan Claimant Documentation from IRO	5,978	5/60	$69.41	498.2	$34,577.75
Clerical Professional Sends IRO Adverse Determination Info from Plan	11,956	5/60	$69.41	996.3	$69,155.50
Clerical Professional Notify Claimant and Plan of Final External Appeal Result	11,956	5/60	$69.41	996.3	$69,155.50
Clerical Professional Provides Records for Claims and Appeals	11,956	5/60	$69.41	996.3	$69,155.50
Three-Year Total…..........................................	209,229	-	-	25,406	$2,131,685
Annual Average…….......................................	69,743	-	-	8,469	$710,562
*The annual average cost is calculated as the total cost averaged across three years of the rule

This leads to an annual burden of 8,469 hours with an equivalent cost of $710,562 related to external reviews.

Summary

In total, the annual burden associated with claims, appeals, and external review is approximately 36,739 hours at an equivalent cost of $3,108,445 annually.

Because the burden is shared equally between DOL and the Department of the Treasury, the DOL’s annual share is 18,370 hours at an equivalent cost of $1,554,223 annually.

Table 4. -- Estimated Annualized Respondent Equivalent Cost and Hour Burden
Activity	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden (Hours)	Total Burden (Hours)	Hourly  Wage Rate	Equivalent Cost of Hour Burden
Medical Secretary Produces Fair and Full Review Notice	14,442	1	14,442	5/60	1,203.5	$64.46	$77,577.61
Physician Drafts Appeal Response	592	1	592	20/60	197.3	$208.88	$41,218.99
Medical Secretary Produces Fair and Full Review Notice	276,981	1	276,981	5/60	23,081.8	$64.46	$1,487,849.61
Physician Drafts Appeal Response	11,364	1	11,364	20/60	3,788.0	$208.88	$791,237.44
Human Resource Specialist Reviews Appeal Requests	15,941	1	15,941	15/60	3,985.3	$100.21	$399,361.90
Clerical Professional Notifies Claimant of Appeal Acceptance	11,956	1	11,956	5/60	996.3	$69.41	$69,155.50
Clerical Professional Sends Plan Claimant Documentation from IRO	5,978	1	5,978	5/60	498.2	$69.41	$34,577.75
Clerical Professional Sends IRO Adverse Determination Info from Plan	11,956	1	11,956	5/60	996.3	$69.41	$69,155.50
Clerical Professional Notify Claimant and Plan of Final External Appeal Result	11,956	1	11,956	5/60	996.3	$69.41	$69,155.50
Clerical Professional Provides Records for Claims and Appeals	11,956	1	11,956	5/60	996.3	$69.41	$69,155.50
Annual Total……..	2,588,299	0.1450	375,202**	-	36,739	-	$3,108,445
DOL’s Total***….	1,294,150	0.1450	187,601	-	18,370	-	$1,554,223

*The total number of respondents is the total number of ERISA-covered group health plans.

** The number of responses was calculated in the following manner: 15,942 (Preliminary Review) + 11,956 (Notice of Eligibility) + 11,956 (Plan provides IRO with documentation and other information considered in making adverse benefit determination) + 5,978 (IRO send documentation regarding adverse benefit determination to Plan) + 11,956 (IRO sends notice to plan regarding final results of the review) + 11,956 (Record Retention) + 291,423 (Full and Fair Review) + 11,956 (External Review) + 2,079 (Linguistically Appropriate Notices) = 375,202. It should be noted that the hour burden for Linguistically Appropriate Notices is de minimis.

*** The burden is shared equally between DOL and the Department of the Treasury.

****Please note that the numbers in the table are rounded.

13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 or 14).

• 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.

Claims and Appeals

The Departments estimate that approximately 42 percent of these notices will be mailed and approximately 58 percent will be delivered electronically. The Departments assume that each of these notices will be five pages and, for mailed notices, have a cost burden of $0.98. ¹⁴ See Table 5 below for more detailed calculations of the cost burdens.

Table 5. -- Cost Burden for Claims and Appeals
	Responses	Mailing Rate	Notices Mailed	Unit Cost	Annual Cost
	(A)	(B)	(A x B)	(C)	(A x B x C)
Full and Fair Review Notice	291,423	42%	121,523	$0.98	$119,092.54
External Review Notice	11,956	42%	4,986	$0.98	$4,886.28
Three-Year Total…..............	910,137	-	379,527	-	$371,936
Annual Average……...........	303,379	-	126,509	-	$123,979
*The annual average cost is calculated as the total cost averaged across three years of the rule

Non-English Language Assistance

As a result of the May 2011 amendment to the interim final regulations, plans and issuers must provide participants and beneficiaries who reside in a county where ten percent or more of the population residing in the county is literate only in the same non-English language with a one-sentence statement in all notices written in the applicable non-English language about the availability of language services. In addition to including the statement, plans and issuers are required to provide a customer assistance process (such as a telephone hotline) with oral language services in the non-English language and provide written notices in the non-English language upon request.

The Departments understand that oral translation services are already provided for nearly all covered participants and beneficiaries. Therefore, no additional burden is associated with this requirement of the amendment.

The Departments expect that the largest cost associated with the rules for culturally and linguistically appropriate notices will be for plans and issuers to provide notices in the applicable non-English language upon request. Based on the American Community Survey (ACS),¹⁵ the Departments estimate that there are about 8.5 million individuals living in counties that are literate in a non-English Language. The ACS does not have insurance coverage information. Therefore, to estimate the percentage of the 8.5 million affected individuals that were insured, the Departments used the percent of the population in the state that reported being insured by private employer insurance from the 2023 Current Population Survey (CPS).¹⁶ This results in an estimate of approximately 3.3 million individuals who are eligible to request translation services.

In discussions with the regulated community, the Departments found that experience in California, which has a state law requirement for providing translation services, indicates that requests for translations of written documents averages 0.098 requests per 1,000 members. While the California law is not identical, and the demographics for California do not match other counties, for purposes of this analysis, the Departments used this percentage to estimate of the number of translation service requests that plan and issuers can expect to receive. Industry experts also told the Departments that while the cost of translation services varies, $500 per document is a reasonable approximation of translation cost.

Using the ACS and the CPS, the Departments estimates that there are 21.2 million individuals insured through private employer sponsored insurance living in the affected counties. See Table 6 below for a detailed estimate of the cost to provide translation services for this population.

Table 6. -- Cost Burden for Linguistically Appropriate Notices
Description	Responses	Request Rate	Translation Requests	Translation Cost	Annual Cost
	(A)	(B)	(C)	(D)	(A x B x C x D)
Notice Translation Expenses	21,204,723	0.0098%	2,078	$500.00	$1,039,000.00
Three-Year Total…..............	63,614,168	-	6,234	-	$3,117,000
Annual Average……...........	21,204,723	-	2,078	-	$1,039,000
*The annual average cost is calculated as the total cost averaged across three years of the rule

Federal External Review

The preliminary review by grandfathered and non-grandfathered ERISA plans of the request for external review is estimated to be a single page. Once an eligibility determination is made, plans must provide the IRO with all documentation and other information considered in making an adverse benefit determination. The Departments assume that each set of documentation will be 20 pages. IROs must also send each eligible claimant a notice of eligibility and acceptance, which the Departments assumes will be a single page.

Additionally, IROs are required to send to plans all documents that claimants submit. The Departments do not know what fraction of claimants will submit additional documentation, but for purposes of this burden analysis assume that half of claimants (5,978) do. Finally, IROs are required to notify the claimant and plan of the result of the final external appeal. The Departments assume that such documentation, as well as the final external appeal result, will be 10 pages. The Departments are not able to estimate the number of reversals and the associated notices to claimants and IROs that plans would send due to reversing its prior decision but believes the number would be small.

The Departments assume that 100 percent of notices related to the external review will be mailed to participants and that each page of a physical notice will incur a cost of $0.05 while each individual notice will incur a cost of $0.73 for postage. For detailed calculations of the cost burden related to the Federal External Review, see the Table 7 below.

Table 7. -- Cost Burden for Federal External Review
Description	Responses	Mailing Rate	Notices Mailed	Unit Cost	Annual Cost
	(A)	(B)	(C)	(A x B)	(A x B x C)
Request for External Review	15,941	100%	15,941	$0.78	$12,433.98
Plans Send IRO Documentation	11,956	100%	11,956	$1.73	$20,683.88
IROs Send Claimants Eligibility Notice	11,956	100%	11,956	$0.78	$9,325.68
IROs Send Plans Documentation from Claimants	5,978	100%	5,978	$1.23	$7,352.94
IROs Notify Claimant and Plan of Final External Appeal Outcome	11,956	100%	11,956	$1.23	$14,705.88
Three-Year Total…................................	53,802	-	53,802	-	$193,507
Annual Average……........................	17,934	-	17,934	-	$64,502

*The annual average cost is calculated as the total cost averaged across three years of the rule

Summary

In total, the estimated material and postage costs associated with distributing claims and appeals, language translation, and external review is $1,227,481 annually.

Because the burden is shared equally between the DOL and the Department of the Treasury, the DOL’s share approximately $613,741 annually.

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.

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

Adjustments to the burden estimates result from updated estimates on the number of ERISA-covered plans and policyholders and increases in wage rates and postage rates, as well as a change to how the number of plans is calculated. These changes result in 713,149 fewer respondents, a decrease of 202,973 responses, a decline of the hour burden by 677 hours, and increase of the cost burden by $11,715 compared with the prior submission.

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.

Not applicable.

18. Explain each exception to the certification statement.

There are no exceptions to the certification statement.

B. COLLECTIONS OF INFORMATON EMPLOYING STATISTICAL METHODS. 

There are no statistical methods used in this information collection.

1 Such evidence must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date. Additionally, before the plan or issuer can issue an adverse benefit determination on review based on a new or additional rationale, the claimant must be provided, free of charge, with the rationale. The rationale must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date.

2 29 CFR 2560.503‑1(f)(2)(i).

3 29 CFR 2560.503‑1(f)(2)(ii)(B).

4 29 CFR 2560.503‑1(f)(2)(iii)(A)

5 29 CFR 2560.503‑1(f)(2)(iii)(B)

6 29 CFR 2560.503‑1(f)(3)

7 Such evidence must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date. Additionally, before the plan or issuer can issue an adverse benefit determination on review based on a new or additional rationale, the claimant must be provided, free of charge, with the rationale. The rationale must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date.

8 Internal DOL calculation based on 2024 labor cost data. For a description of the Department’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.

9 U.S. Department of Labor, EBSA Abstract of Auxiliary Data for the March 2023 Annual Social and Economic Supplement to the Current Population Survey.

10 These states are Alabama, Texas, Florida, Georgia, and Wisconsin. See Affordable Care Act: Working with States to Protect Consumers, available at https://www.cms.gov/CCIIO/Resources/Files/external_appeals.html

11 AHIP Center for Policy and Research, An Update on State External Review Programs, 2006, July 2008.

12 North Carolina Department of Insurance, Health Insurance Smart NC: Annual Report on External Review Activity 2013.

13 Internal DOL calculation based on 2020 labor cost data. For a description of the Department’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.

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15 Data are from the 2022 American Community Survey 5-Year estimates (2018-2022) and available at www.census.gov/acs. Individuals counted reside in counties where at least 10 percent of the county speak a particular non-English language and speak English less than “very well” are counted.

16 Please note that using state estimates of insurance coverage could lead to an over estimate if those reporting in the ACS survey that they speak English less than “very well” are less likely to be insured than the state average.

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