1. Purpose. The purpose of this section is to provide guidance on health case openings and initial reviews.

  2. Criteria. RO should open a case involving a group health plan or health service provider (other than criminal health fraud) as a Program 50.

    1. Health investigations may include a review of all applicable ERISA provisions including: (1) disclosure provisions under Part 1; (2) the fiduciary provisions under Part 4; (3) the benefit claims procedure regulations under Part 5; and (4) group health plan requirements under ERISA Parts 6 and 7 relating to all applicable health laws including:

      1. Consolidated Omnibus Budget Reconciliation Act (COBRA);

      2. Health Insurance Portability and Accountability Act (HIPAA);

      3. Mental Health Parity Act (MHPA);

      4. Mental Health Parity and Addiction Equity Act (MHPAEA);

      5. Women's Health and Cancer Rights Act (WHCRA);

      6. Newborns' and Mothers' Health Protection Act (Newborns' Act);

      7. Genetic Information Nondiscrimination Act (GINA);

      8. Michelle's Law;

      9. Children's Health Insurance Program Reauthorization Act (CHIPRA);

      10. Patient Protection and Affordable Care Act (Affordable Care Act or ACA).

    2. If an enforcement action raises issues under the shared provisions of Part 7, it must reflect interpretations of the laws cleared by the Departments of Labor, Treasury and Health and Human Services.(1)

    3. ERISA also requires group health plans to:

      1. Provide participants with plan information, including important information about plan features and funding;

      2. Provide fiduciary responsibilities for those who manage and control plan assets;

      3. Plan to establish a grievance and appeals process for participants to get benefits from their plans;

      4. Give participants notice of their right to sue for benefits and breaches of fiduciary duty ; and

      5. Include rules relating to plan eligibility and coverage requirements.

  3. Plan-level Investigations. The ROs conduct plan-level investigations of fully and self-insured group health plans to ensure compliance with ERISA Title I group health plan requirements and to pursue widespread compliance opportunities when appropriate. In addition to Part 7 of Title I, these cases will also examine compliance with other ERISA provisions such as claims administration, failure to provide promised benefits, reasonable administrative fees, potential prohibited transactions, and other issues.

  4. Service Provider Investigations. Generally, any service provider that exercises discretionary authority or discretionary control respecting the management or administration of the plan is a fiduciary. Many self and most fully insured plans frequently include a health insurance issuer that exercises discretion or control over benefit claims decisions.

    Issuers offering health insurance coverage in connection with group health plans are also subject to Part 7 provisions through parallel state and federal laws, and states maintain primary enforcement authority over issuers regarding these rules.

    Service provider investigations typically require an investigation of systemic ERISA violations to ensure service providers, servicing numerous ERISA-covered group health plans, comply with plan documents, and pay health benefit claims according to plan terms and applicable claims processing regulations. These cases focus on procedural, substantive and disclosure violations related to the denial of promised health benefits. Service provider cases may involve the same investigative issues as plan-level cases, although they generally are more complex due to the large number of transactions at issue (e.g., plan-wide patterns of claim processing errors).

  5. Elements of Violations of Part 7. The following are basic elements of Part 7 violations:

    1. The provisions of Part 7 of Title I of ERISA cover the subject plan(s) involved.

    2. The plan provisions or practices did not comply with the requirements under Part 7. Collect sufficient evidence to establish the plan’s non-compliance with one or more statutory and regulatory provisions of Part 7.

  6. Widespread Compliance. In the health insurance industry, it is common for issuers or other service providers to issue standardized plan documents and other material to ERISA plan clients. To leverage its resources, EBSA identifies service providers who provide non-compliant health insurance policies or standardized plan documents and pursues global corrections, affecting all plans governed by the faulty policies or plan documents.

  7. Case Development. Enforcement strategies, annual operating plans, and National Office policy statements provide direction to identify areas of potential non-compliance and may emphasize the review and investigation of certain types of plan-level cases, service providers, MEWAs, or other specific matters. All identification of areas for potential non-compliance reflects, and is consistent with, such direction. Additionally, ROs should consider implementing supplemental efforts to national enforcement strategies, annual operating plans, and policy guidance. Supplemental efforts may reflect factors such as local economic conditions, geographical coverage within an RO jurisdiction, and specialized plan types.

    Sources for potential health plan investigations include:

    1. Computer generated compilations of selected employee health benefit plans or service providers derived from reports filed with EBSA;

    2. Information derived from detailed review and analysis of annual reports, supporting financial statements, schedules, exemption application files, ERISA Section 502 complaints, and other internal EBSA sources;

    3. Information concerning employee health benefit plans or service providers derived from other governmental agencies such as HHS and state insurance agencies;

    4. Information concerning employee health benefit plans or service providers derived from non-governmental sources such as newspapers, industry journals and magazines, or leads from knowledgeable parties such as patient advocacy groups, or private litigation;

    5. Complaints from participants, fiduciaries, informants, or other sources in the community. Allegations of acts against a participant or beneficiary for exercising any right to which he/she is entitled under the provisions of an employee benefit plan, or interfering with the attainment of any right to which the participant may become entitled, should be handled as described in the Participants' Rights section;

    6. Compilations of selected employee health benefit plans or service providers derived by using combinations of the sources.

    For additional methods of case identification, please refer to the Fiduciary Investigations section.

  8. Case Opening. Please refer to the Fiduciary Investigations section.

  9. Investigative Activity, Full Review. Health investigations should include a review for compliance with all applicable ERISA provisions. This includes review for compliance with the fiduciary provisions, claims procedure rules, and Parts 6 and 7. Generally, the Investigator/Auditor should evaluate every health plan/benefit package option offered for Part 7 compliance. This review will typically include an operational review of claims data, claims listings and/or claims.

  10. Document Request Letters and Subpoenas. After case opening, the Investigator/Auditor may use a document request letter to request information beyond what is necessary to support information filed with the Secretary under Title I of ERISA. Such letters may not request creation of documents, but may request production of existing documents. The Investigator/Auditor may send letters to the Plan, Plan Sponsor, and Plan service providers (including but not limited to health insurance issuers and third party administrators).

    Figure 1 and Figure 2 is an example of a health request letter. The information requested for any particular investigation may vary from these examples depending on the facts and circumstances of the investigation. Depending on the circumstances, the Investigator/Auditor may send a subpoena pursuant to Subpoena section in conjunction with or in lieu of a Document Request Letter. Subsequent document requests or subpoenas for information may be necessary. The HIPAA privacy regulations, collectively known as the "Privacy Rule," set forth several "permitted uses or disclosures" or "standards" that allow covered entities to disclose protected health information without patient authorization.

    In consultation with its SOL and before issuance of a subpoena, EBSA reviews its investigatory objectives in a specific investigation to ensure that the information requested is the minimum necessary to accomplish its investigative objectives. Special procedures are necessary when a RO receives such information.

    For additional techniques relating to investigative activity, please refer to the Fiduciary Investigations Manual section.

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(Figure 1)
Model Health Plan Document Request Letter

Certified Mail No.
Return Receipt Requested

xx
Plan Administrator
xx Health Plan
xx
xx

RE: xx Health Plan

Case No.

Dear Plan Administrator:

The Department of Labor has responsibility for the administration and enforcement of Title I of the Employee Retirement Income Security Act of 1974 (ERISA). Title I establishes standards governing the operation of employee benefit plans such as the xx Health Plan (the Plan).

The Plan is scheduled for investigation by this office. Investigative authority is vested in the Secretary of Labor by Section 504 of ERISA, 29 U.S.C. 1134, which states in part:

  1. The Secretary [of Labor] shall have the power, in order to determine whether any person has violated or is about to violate any provision of this title or any regulation or order thereunder...to make an investigation, and in connection therewith to require the submission of reports, books, and records, and the filing of data in support of any information required to be filed with the Secretary under this title ....

Additionally, the Plan will be examined for the purpose of determining whether it is complying with the laws contained in Part 7 of ERISA, including the Health Insurance Portability and Accountability Act of 1996, the Newborns' and Mothers' Health Protection Act, the Women's Health and Cancer Rights Act (WHCRA), the Mental Health Parity and Addiction Equity Act, the Genetic Information Nondiscrimination Act, and the Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act (collectively, the Affordable Care Act). These laws amended Part 7 of ERISA and provide requirements for group health plans.

We have found in the past that submission of relevant documents to our office prior to the inception of an on-site field investigation can lessen the time subsequently spent with, and the administrative burden placed on, plan and corporate officials and may eliminate the need for an on-site visit entirely. To that end, we ask that you submit to this office, within ten business days of your receipt of this letter, the documentation listed on the enclosed Attachment A. If any items are not applicable, please so indicate and provide an explanation.

Thank you in advance for your cooperation. Should you have any questions, please contact the undersigned at XXX-XXX-XXXX.

Sincerely,

Attachment

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(Figure 2)
Copies of Items Identified Below Should Be Submitted as Indicated in the Cover Letter

  1. Plan document(s), including the following:

    1. Summary Plan Description (SPD);

    2. Wrap document;

    3. Benefits booklets;

    4. Employee handbooks which discuss employee benefits;

    5. Evidences of coverage (EOCs) and Certificates of Coverage for each medical option;

    6. Enrollment package provided to participants at open enrollment and new hire, including front and back of all enrollment forms; and

    7. Documents describing plan coverages, rules, costs, or changes to any of the above documents, including any Notices of Material Modifications.

  2. Summary of Benefits and Coverage (SBC) and Uniform Glossary.

  3. All contracts with service providers, including brokers, consultants, third party administrators, record-keepers, claims processors. Contracts should include any performance agreements and fee schedules reflecting compensation.

    1. If self-insured/self-funded, all contracts for claims processing, administrative services, and reinsurance; and

    2. If fully-insured, all contracts with insurance companies for the provision of health benefits.

  4. Documents describing the cost of coverage for each option (e.g., HMO, PPO) under the Plan, including premiums by type of coverage (e.g., single, family), employee vs. employer share of cost of coverage, and the cost of COBRA coverage.

  5. Current fidelity bond policy, including all endorsements and riders, if applicable.

  6. Current fiduciary insurance policy, including all endorsements and riders, if applicable.

  7. Latest Form 5500 Annual Report filing and any associated financial statements/schedules and accountant’s opinion, if applicable.

  8. The most recent Collective Bargaining Agreement(s);

  9. Listing of all individuals (name, position, contact information) directly or indirectly responsible for the operation, administration, and/or oversight of the Plan. This includes trustees, administrative or oversight committee members, and accounting or human resources personnel who process plan paperwork, such as enrollment, claims, participant inquiries, and premium payments.

  10. If the Plan has any assets and/or trust:

    1. Signed copy of the Trust Agreement and any other governing documents; and

    2. Documents sufficient to show the Plan’s income, expenses, assets, and liabilities on a quarterly basis for the period under review.

  11. Samples of all COBRA notices, including general notice, election notice, qualifying event notice, notice of unavailability of continuation coverage, and notice of early termination of coverage.

  12. Sample Explanation of Benefits for a denied claim (EOB);

  13. In accordance with the Health Insurance Portability and Accountability Act of 1996, please provide the following records:

    1. The Plan’s rules for eligibility to enroll under the terms of the Plan (including continued eligibility);

    2. Written procedures providing special enrollment rights (e.g. to individuals who lose other coverage or acquire a new dependent);

    3. If any employees reside in a state with a Children’s Health Insurance Program (CHIP) offering premium assistance, provide the CHIP notice informing participants of possible eligibility for premium assistance; and

    4. Written claims and appeal procedures established by the Plan.

  14. The Plan’s rules regarding coverage of medical/surgical and mental health benefits, including information as to any aggregate lifetime dollar limits and annual dollar limits, if not included in response to Request #1 above.

  15. Notice to participants regarding rights under the Newborns’ and Mothers’ Health Protection Act (should appear in the Plan’s SPD), if not included in response to Request #1 above.

  16. Rules regarding pre-authorization or pre-service review for a hospital length of stay in connection with childbirth, if not included in response to Request #1 above.

  17. Written description of benefits mandated by Women’s Health and Cancer Rights Act (should be provided at enrollment and annually thereafter), if not included in response to Request #1 above.

  18. Documents describing any wellness programs (such as smoking cessation, weight loss, or disease management programs) offered by the Plan, including a description of any reward offered as part of the program and any alternative means of participating in such a program, if not included in response to Request #1 above.

  19. If the Plan is claiming or has claimed grandfathered health plan status within the meaning of Section 1251 of the Affordable Care Act, please provide the following:

    1. Grandfathered health plan status disclosure statement included in plan materials provided to participants;

    2. Records necessary to verify, explain, or clarify grandfathered status, including plan terms in effect as of March 23, 2010, any changes to cost-sharing provisions, changes to employer or employee contributions towards the cost of coverage, changes to annual or lifetime limits, and change in health insurance issuers; and

    3. Any applicable testing completed by the Plan to ensure the Plan’s grandfathered health plan status.

  20. Regardless of whether the Plan is claiming grandfathered status, please provide the following records in accordance with section 715 of ERISA as added by the Affordable Care Act, if not already provided in response to Request #1:

    1. Written notice describing enrollment opportunities relating to dependent coverage of children to age 26, if the Plan provides dependent coverage;

    2. A list of participants or beneficiaries whose coverage has been rescinded, the reason for the rescission, and a copy of the written notice of rescission that was provided 30 days in advance of any rescission of coverage; and

    3. Documents indicating any lifetime or annual limits imposed, if applicable.

    4. Documents indicating any waiting periods imposed, if applicable, before coverage is effective.

  21. If the Plan is NOT claiming grandfathered health plan status under section 1251 of the Affordable Care Act, please also provide the following records:

    1. Notice to participants of their right to designate a participating primary care provider, pediatrician, or obstetrician/gynecologist;

    2. Documents describing coverage of any emergency services;

    3. Documents describing coverage of preventive services;

    4. Documents describing the Plan’s Internal Claim and Appeals and External Review Processes;

    5. Samples of an initial adverse benefit determination (denial), notice of adverse benefit determination on internal/administrative appeal (denial upheld on appeal), and final notice of adverse benefit determination on external review decision (denial upheld on external review); and

    6. If applicable, any contract or agreement with any independent review organization or third party administrator providing external review.

  22. For all rebates (including medical loss ratio rebates, experience-rated contract rebates, and any other rebate from an insurer) received by the Plan or plan sponsor in relation to plan coverage:

    1. Documents detailing the amount, receipt date, source, and handling of each rebate;

    2. Sample of notice to participants about rebates, if applicable;

    3. Documents demonstrating the allocation of rebated amounts to employer and/or employees; and

    4. Correspondence regarding how rebates are to be used or allocated.

  23. All Plan materials related to the Plan’s compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA), including any applicable parity testing completed by the Plan to ensure the Plan’s mental health and substance abuse benefits are provided in accordance with MHPAEA.

  24. Listing or report identifying all Plan’s claims, claims grievances or appeals, and all requests for prior or pre-authorization as indicated on additional attachment [if applicable].

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Footnotes

  1. The Memorandum of Understanding (MOU) between the Departments of Labor, Treasury and Health and Human Services formally establishes an interagency agreement to ensure consistent and uniform administration of regulations, rulings, and interpretations relating to HIPAA and other laws among the Departments.