• Church Plan - In general, a church plan is a plan established or maintained for its employees or their beneficiaries by a church or by a convention or association of churches that is exempt from tax under section 501 of the Internal Revenue Code (Code).
• Employer Identification Number (EIN) - An EIN is a nine-digit employer identification number (for example, 00-1234567) that has been assigned by the Internal Revenue Service (IRS). Entities that do not have an EIN should apply for one on Form SS-4, Application for Employer Identification Number as soon as possible. You can obtain Form SS-4 by calling 1.800.829.4933 or at the IRS Website at www.irs.gov.
• Group Health Insurance Coverage - Group health insurance coverage means health insurance coverage offered in connection with a group health plan.
• Group Health Plan - In general, a group health plan means an employee welfare benefit plan to the extent that the plan provides benefits for medical care to employees (including both current and former employees) or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise. See section 733(a) of the Employee Retirement Income Security Act (ERISA) and 29 CFR 2590.732(a). See also section 5000(b)(1) of the Code.
• Health Insurance Coverage - Health insurance coverage means benefits consisting of medical care (provided directly, through insurance or reimbursement, or otherwise) under any hospital or medical service policy or certificate, hospital or medical service plan contract, or HMO contract offered by a health insurance issuer. Health insurance coverage includes group health insurance coverage and individual health insurance coverage.
• Health Insurance Issuer or Issuer - The term "health insurance issuer" or "issuer" is defined, in pertinent part, in 29 CFR 2590.701-2 as "an insurance company, insurance service, or insurance organization (including an HMO) that is required to be licensed to engage in the business of insurance in a State and that is subject to State law which regulates insurance….Such term does not include a group health plan."
• Individual Health Insurance Coverage - Individual health insurance coverage means health insurance coverage offered to individuals in the individual market, but does not include short-term, limited duration insurance. Individual health insurance coverage can include dependent coverage.
• Nonfederal Governmental Plan - Nonfederal governmental plan means a governmental plan that is not a Federal governmental plan.
• Plan Number (PN) - A PN is a three-digit number assigned to a plan or other entity by an employer or plan administrator. For plans or other entities providing welfare benefits, the first plan number should be number 501 and additional plans should be numbered consecutively.
• Underwriting Purposes - With respect to any group health plan, or health insurance coverage offered in connection with a group health plan:
  • Rules for, or determination of eligibility (including enrollment and continued eligibility) for benefits under the plan or coverage;
  • The computation of premium or contribution amounts under the plan or coverage;
  • The application of any preexisting condition exclusion under the plan or coverage; and
  • Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.

A plan or issuer claiming the research exception must file at least 60 days prior to the date the first request is made to a participant or beneficiary to undergo a genetic test.

Part I: Entity Classification and Identification

Item 1

• Enter the date this filing is being submitted.

Item 2

• Check either box 2(A) or box 2(B).
• Box 2(A): Check this box if the entity claiming the research exception is a group health plan. (See Section II for the definition of a group health plan.)
• Box 2(B): Check this box if the entity claiming the research exception is a health insurance issuer. (See Section II for the definition of a health insurance issuer.)

If you checked box 2(A), complete item 3 and skip item 4. If you checked box 2(B), skip item 3 and complete item 4.

Item 3

• If you checked box 2(A), check one of the following: box 3(A), box 3(B), or box 3(C).
• Box 3(A): Check this box if the entity is a group health plan subject to Part 7 of Title I of ERISA. (See Section II for a discussion of plans subject to Part 7 of Title I of ERISA.)
• Box 3(B): Check this box if the entity is a group health plan that is a church plan (See Section II for the definition of a church plan.)
• Box 3(C): Check this box if the entity is a group health plan that is a nonfederal governmental plan. (See Section II for the definition of a nonfederal governmental plan.)

Item 4

• If you checked box 2(B), check one of the following: box 4(A), box 4(B), or box 4(C).
• Box 4(A): Check this box if the entity is a health insurance issuer claiming the exception in connection with the provision of group health insurance coverage only.
• Box 4(B): Check this box if the entity is a health insurance issuer claiming the exception in connection with the provision of individual health insurance coverage only.
• Box 4(C): Check this box if the entity is a health insurance issuer claiming the exception in connection with both group and individual health insurance coverage.

Items 5a through 5d

• Enter the name, address, and telephone number of the entity claiming the research exception, and any EIN or PN used by the entity in reporting to the Department of Labor or the Internal Revenue Service. If the entity does not have any EINs associated with it, leave item 5c blank. If the entity does not have any PNs associated with it, leave item 5d blank. For more information on EINs or PBs, see Section II on Definitions.

Part II: Research Project Information

Item 6

• Provide the title of the research project.

Item 7

• Provide the name of the principal investigator for the research project.

Item 8

• Provide the research project number, if available.

Part III: Attestation of Compliance with the Requirements of the Research Exception

• Sign the attestation, certifying compliance with the requirements of the research exception and declaring the contents of the filing true and correct. Type or print the relevant contact information.