Title I of the Genetic Information Nondiscrimination Act of 2008 (“GINA”) prohibits group health plans, health insurance issuers, and issuers of Medicare supplemental policies from discriminating against an individual based on his or her genetic information. On October 7, 2009, interim final regulations under Title I of GINA (“interim regulations”) were published jointly by the Departments of Labor, Health and Human Services, and the Treasury, providing much needed clarification regarding GINA’s restrictions on collecting genetic information. The interim regulations are effective for plan years beginning on or after December 7, 2009 (i.e., a group health plan with a calendar year will need to comply with these interim regulations beginning January 1, 2010). Employers will need to quickly evaluate how these new interim regulations will impact their wellness programs—particularly the design and use of health risk assessments (“HRAs”).

Overview of Title I of GINA

Title I of GINA limits the collection and use of “genetic information” by group health plans and health insurance issuers. The new interim regulations define “genetic information” broadly. The following all qualify as genetic information:

• Information about an individual’s genetic tests. GINA defines a “genetic test” to include an analysis of human DNA, RNA, chromosomes, proteins or metabolites if it detects genotypes, mutations, or chromosomal changes. For example, a test to determine whether an individual has a gene that predisposes them to breast cancer (i.e., BRAC1 or BRAC2) is a genetic test. However, an HIV test, complete blood count, cholesterol test, liver function test, or a test for the presence of alcohol or drugs is not a genetic test.
• Information about the genetic tests of family members of the individual. It should be noted that the interim regulations define “family member” broadly in order to provide the maximum amount of protection against discrimination. Family members include:
  • dependents of the individual; and
  • any other individuals that are the first, second, third, or fourth degree relatives of the individual or his her dependent (i.e., mother through great, great grandmother).

  The interim regulations also clarify that relatives by affinity (such as by marriage or adoption) are treated the same as blood relatives. Also, relatives who are not full blood relatives (i.e., half siblings) are treated the same as full blood relatives.

• The manifestation of a disease or disorder in family members of the individual (i.e., family medical history).
• Any request for, or receipt of genetic services (i.e., genetic testing, genetic counseling, or genetic education) by the individual or a family member.

Prohibitions under GINA

Title I of GINA specifically prohibits group health plans and health insurance issuers from:

• increasing group premiums or contribution amounts based on genetic information;
• requesting or requiring that an individual or his or her family member undergo genetic testing (subject to certain exceptions); and
• requesting, requiring or purchasing genetic information prior to or in connection with enrollment, or at any time for underwriting purposes.

The interim regulations expand and clarify upon these prohibitions under GINA, as explained below.

Prohibition against Adjusting Group Premiums

In a reversal of prior law, GINA and the interim regulations prohibit group health plans and health insurance issuers from adjusting premiums or contribution rates for a group health plan on the basis of genetic information. Under GINA, even if a group health plan or insurer has lawfully obtained genetic test results (e.g., the group health plan collected the genetic information prior to GINA’s effective date), the group health plan or insurer is still prohibited from using this genetic information to discriminate on and after GINA’s effective date.

However, the interim regulations clarify that GINA does not limit the ability of a group health plan or insurer to increase premiums or contribution rates based on the actual manifestation of a disease or disorder in an individual.

Limitations on Requesting Genetic Information for Testing

Generally, group health plans and health insurance issuers may not request or require that individuals or their family members undergo genetic testing. However, the interim regulations provide three exceptions to this prohibition:

• A healthcare professional who is providing healthcare services to an individual may request the individual undergo genetic testing.
• A group health plan or insurer is permitted to request that an individual or his or her covered dependent undergo genetic testing for research purposes, as long as certain conditions and requirements are met (e.g., the request is made in writing, the group health plan or insurer completes a copy of the Notice of Research Exception available on the Department of Labor’s website, etc.).
• A group health plan or insurer may obtain and use the results of a genetic test to make a determination regarding payment. The group health plan or insurer may only request the minimum amount of information necessary to make the determination regarding payment. For example, if a group health plan generally covers a yearly mammogram for participants who are over age 40 but will cover a yearly mammogram for participants who are younger and who have an increased risk of breast cancer, then the group health plan is permitted to require proof of this increased risk of breast cancer (such as the results of a genetic test or a family medical history of breast cancer) before a mammogram claim for a participant younger than 40 is paid.

Prohibition on Collection of Genetic Information

GINA prohibits group health plans and health insurance issuers from collecting genetic information prior to or in connection with enrollment. The interim regulations explain that genetic information is considered collected “prior to or in connection with enrollment” if the employer collects this information before the individual’s effective date of coverage under the group health plan.

GINA also prohibits group health plans and health insurance issuers from collecting genetic information for “underwriting purposes.” The preamble to the interim regulations clarifies that underwriting is not limited to activities relating to rating and pricing of a group policy, and the interim regulations broadly define underwriting to include the following:

• Rules for determining eligibility (including enrollment and continued eligibility) for benefits under the plan, (including changes in deductibles or other cost-sharing mechanisms in return for activities such as completing an HRA or participating in a wellness program)
• Computation of premium or contribution amounts under the plan (including discounts, rebates, payments in kind, or other premium differentials in return for completing an HRA or participating in a wellness program)
• The application of any preexisting condition exclusion under the plan
• Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits

GINA’s Impact on HRAs and Wellness Programs

The rules prohibiting group health plans and health insurance issuers from collecting genetic information prior to enrollment or in connection with underwriting purposes will significantly impact the design and administration of HRAs and wellness programs.

Providing Rewards in Exchange for Completing HRAs

A wellness program that provides rewards (e.g., discounts on premiums or deductibles, waivers of annual deductibles, cash bonus payments, etc.) in exchange for completing an HRA that requests genetic information (e.g., family medical history) will violate GINA’s prohibition against collecting genetic information for underwriting purposes. There are no exceptions to this rule, regardless of the amount of the reward or incentive.

Requesting Completion of an HRA Prior to Enrollment

If a group health plan requests that enrollees complete an HRA with questions regarding genetic information (e.g., family medically history) prior to enrollment, this violates GINA’s prohibition against collecting genetic information prior to or in connection with enrollment — even if there is no reward provided in exchange for completing the HRA.

Eligibility for Additional Benefits after Completing an HRA

A wellness program that provides eligibility for additional benefits under the group health plan (e.g., eligibility for enrollment in a disease management program) upon an individual’s completion of an HRA that contains questions regarding genetic information violates GINA’s prohibition against collecting genetic information for underwriting purposes.

Broadly Worded HRAs

Even if an HRA does not directly request genetic information, care should be taken to avoid broadly worded questions. For example, if an HRA asks, “Is there anything else relevant to your health that you would like us to know or discuss with you?” and this results in the collection of genetic information, the group health plan risks violating GINA. To avoid this result, the HRA should also explicitly state: “In answering this question, you should not include any genetic information (i.e., do not include any family medical history, or any information related to genetic testing, genetic services, genetic counseling, or genetic diseases for which you believe you may be at risk).”

Although GINA will limit the way HRAs and wellness programs may be designed, a group health plan may choose to use the following strategies for complying with the interim regulations:

• Remove Genetic Information QuestionsIf the group health plan wants to offer rewards or incentives in exchange for completing an HRA, the group health plan must remove all questions relating to genetic information.
• No Rewards OfferedAlternatively, the group health plan could remove any rewards or incentives for completing HRAs that ask questions relating to genetic information (provided these HRAs are not requested to be completed until after the employee has enrolled in the group health plan).
• Two Part HRAThe group health plan could offer an HRA with two parts—one that does not request genetic information (for which a reward may be provided upon completion), and one that does not ask questions relating to genetic information (for which no reward is offered). The second part of the HRA (the part asking questions relating to genetic information) must make it clear that its completion is entirely voluntary and will not affect any rewards given for completing the first part of the HRA (the part that does not ask questions relating to genetic information).

We note that these interim regulations are in line with the Equal Employment Opportunity Commission’s (the “EEOC”) stance on HRAs. The EEOC has issued informal opinion letters stating that disability related inquiries may be permissible only as part of a “voluntary wellness program” (i.e., a program where employees are not required to participate, and are not penalized for non-participation). In an informal opinion letter dated March 6, 2009, the EEOC found that an employer who required the completion of an HRA as a condition for participating in a self-funded health plan violated the Americans with Disabilities Act (the “ADA”). Further, on August 10, 2009, the EEOC issued an informal opinion letter where it explained that an employer may only ask disability related questions if the questions are “job related and consistent with business necessity.” In this informal opinion letter, the EEOC stated that asking questions about various medical conditions (e.g., heart disease, cancer, asthma, etc.) as a prerequisite for obtaining reimbursement of health expenses “does not appear to be job related and consistent with business necessity.” Accordingly, an employer risks violating the ADA if it requires answers to these types of health related questions before reimbursing the employee for his or her health expenses. Although these informal opinion letters are not binding, these letters do provide insight into the EEOC’s viewpoint on HRAs.

Proposed HIPAA Privacy Regulations

GINA also required the Department of Health and Human Services (“HHS”) to revise the HIPAA privacy rules to prohibit the use or disclosure of genetic information for underwriting purposes. In response, on October 7, 2009, HHS issued proposed HIPAA privacy regulations that coordinate with the GINA Title I interim regulations. These proposed regulations specifically state that genetic information is health information. Further, the proposed regulations explicitly prohibit the use or disclosure of genetic information for underwriting purposes by a health plan. Lastly, these proposed regulations will require health plans to revise their Notices of Privacy Practices to include a statement that genetic information cannot be used or disclosed for underwriting purposes. Typically, if there is a material change to a Notice of Privacy Practices, health plans are required to issue an updated notice within 60 days of the material change. In the preamble to the proposed HIPAA privacy regulations, HHS recognized that revising and redistributing a Notice of Privacy Practices may be costly for health plans that perform underwriting, and has solicited comments on how to deal with this issue (e.g., distributing the Notice of Privacy Practices with annual open enrollment materials, etc.). These amendments to the HIPAA privacy rule are proposed to be effective 180 days after final regulations are issued.

Action Items

As stated above, these interim regulations are effective for plan years beginning on or after December 7, 2009. Employers that offer financial incentives to employees for completing HRAs during annual open enrollment periods will need to immediately review and, if necessary, revise these programs to ensure that they do not violate GINA. To the extent that an HRA requesting genetic information (e.g., family medical history) was completed prior to GINA’s effective date it appears that this HRA cannot be used to provide financial incentives on and after GINA’s effective date. Please contact us if you need assistance with reviewing your group health plans, HRAs and/or wellness programs to ensure that they are in compliance with GINA.