On Jan. 10, 2011, the final regulations under Title II of the Genetic Information Nondiscrimination Act (GINA II), which were issued by the Equal Employment Opportunity Commission, went into effect.

While Title I of the GINA left wellness proponents puzzled, GINA II spells out the rules and provides a specific exception for employers who incentivize employee participation in their wellness programs. The requirements are strict, but provide better guidance on how to handle sensitive health information.

GINA II applies to private and state and local government employers with 15 or more employees, employment agencies, labor unions, and joint labor-management training programs. It also covers Congress and federal executive branch agencies. The term "covered entity" is used in this article to refer collectively to all those subject to Title II of GINA.

GINA then and now

On May 21, 2008, President George W. Bush signed the Genetic Information Nondiscrimination Act of 2008.  In large part the legislation was originally enacted to address concerns around the decoding of the human genome, advances in the field of genomic medicine and the increasing number of genetic tests that could now reveal a person’s propensity for developing a specific disease or disorder.

Lawmakers recognized that the revelation of such sensitive genetic information could cause individuals to be denied health coverage. With this issue in mind, GINA provided regulations to govern the gathering and use of genetic information, and was aimed primarily at insurance underwriting guidelines.

GINA I sparks confusion

Despite GINA’s initial intent, the act caused great concern among employers who used health risk assessments (HRAs) as part of their wellness programs because GINA applied a blanket prohibition against using incentives to induce worker participation in HRAs that ask family history questions.

Given that nearly two-thirds of employers offer wellness programs incenting HRA completion, the ruling (if made permanent as written) would impact a very large number of companies and possibly undermine the effectiveness of their health and wellness initiatives.

Fortunately, Congress made it clear that GINA I was not the final ruling, and stakeholders anxiously awaited clarification.

GINA II clarifies compliance  

On Nov, 9, 2010, EEOC issued its final regulations under Title II of GINA. The final ruling takes into account input received by the EEOC from numerous groups and organizations representing individuals, employers and industry professionals.

Specifically, GINA (1) bars the use of genetic information in employment decision-making; (2) restricts deliberate acquisition of genetic information; (3) requires that genetic information be maintained as a confidential medical record; and (4) places strict limits on disclosure of genetic information.

The newly issued final ruling is generally consistent with, but not identical to, the previously issued regulations under Title I. But key for those who offer or are considering offering health and wellness programs to their workforce is that GINA II provides clearer and more specific guidelines for compliance.

Incentives and rewards

The important clarification GINA II brings to health and wellness program administration is that, while employers may not offer an inducement for individuals to provide genetic information, they may offer financial incentives to encourage participation in health or genetic services and request family health history information — if certain requirements are met:

• First, the program must be voluntary. The employee must provide prior, knowing, voluntary and written authorization. The authorization can be in electronic form, but must be recorded prior to asking for the genetic information, and the authorization must describe the information being sought and the safeguards in place to protect its privacy.

• "Bifurcated" HRAs must be offered, clearly stating that completing the section of the questionnaire seeking genetic information is purely optional and that any reward offered will be provided whether that portion is completed or not.

• Any wellness or disease management program offered to address a particular disease or condition must be offered to all qualifying workers, not just those who answered the genetic questions indicating risk for that disease.

• Any incentives to participate in a wellness or disease management program must be available to all workers who qualify for the program — those who volunteered genetic information and those who did not.

• If a covered entity contracts with a third party to operate a wellness program or to provide other health or genetic services, it must ensure that individually identifiable genetic information is accessible only to the individual and the health care provider involved in providing such services and not accessible to managers, supervisors, or others who make employment decisions, or to anyone else in the workplace.

Redefining terms to avoid misunderstandings

One of the major contributions of GINA II is clarification and, in some cases, redefinition of numerous terms deemed too vague, misleading or difficult to understand without scientific knowledge. The following are examples of how GINA II clarified some of the legislation’s most confusing or misconstrued terms.

Deliberate Acquisition: The act cleared up a mischaracterization of this phrase, which was taken to mean an employer had to have specific intent to acquire genetic information to violate the law. In GINA II, no specific intent is required to be in violation.

Request (genetic information): The final statute also broadens the definition of "request," detailing that the term applies to not only personal and family requests, but also internet searches and private effect searches that are likely to result in a covered entity obtaining genetic information by actively listening to third-party conversations.

Inadvertent Discovery: GINA II exempts from liability inadvertent or unintentionally gained knowledge of an individual’s or family’s medical history. The law essentially creates a "safe harbor" if, for example, a manager violates the law because he or she accidentally overhears a conversation about an employee’s health status.

The ruling expands on this and other unintended, "water cooler" disclosures. For example, if an individual gives detailed information in response to a common question about his or her health, such as “how are you?” it is considered "inadvertent discovery."

Family Medical History: In GINA II, Congress notes that a "family medical history" could be used as a surrogate for a genetic trait, and that the definition of “genetic information” has to include "family medical history" to prevent a covered entity from making decisions based on the existence of an inheritable disease of a family member.

Family Member: Interestingly, the statute mandates a very broad definition of family members — broader than the term is understood in the practice of medicine. First, blood relations extend to fourth-degree relatives.  This includes: 

•    children, siblings, parents (first degree);
•    grandparents, grandchildren, uncles, aunts, nephews, nieces and half-siblings (second degree);
•    great grandparents, great grandchildren, great uncles, great aunts and first cousins (third degree); and
•    great-great grandparents and first cousins once removed, or children of a first cousin (fourth degree).

A typical family medical history used for diagnosis and treatment includes information about first-, second- and third-degree relatives.

Then, GINA II adds reference to the ERISA definition of family members as "dependents," which can include persons who are or become related to an individual through marriage, birth, adoption or placement for adoption.

In other words, GINA II firmly upholds ERISA protection, ensuring that covered entities may not discriminate against an employee because of concerns about potential health care costs, including increased health insurance rates, associated with the medical condition of a spouse or adopted child.

Genetic Information: GINA II redefines "genetic information" to include data from genetic tests, the genetic tests of family members and family medical history.

The term also applies to information for or in receipt of a request for genetic services for an individual, their family member, a fetus or a lawfully held embryo. The statute also states that information about age, gender, race and ethnicity does not constitute genetic information.

Genetic Services: The term "genetic services" is now defined to include genetic tests, genetic counseling, and genetic education (whether before or after testing).

Navigating other important regulations

Practically speaking, employers will need to take affirmative steps to avoid running afoul of the law, considering there are other longstanding regulations that also impact wellness programs. Even unintentional violations can result in costly fines.

Here are a few key regulations that mandate compliance:

American with Disabilities Act permits employers to ask employees disability-related questions or give them a medical exam only if the information is job-related.

EEOC notes employees can fill out a questionnaire before participating in a voluntary wellness program, but companies cannot make eligibility for health insurance contingent on completing the questionnaire.

Under HIPAA, employers offering incentives to promote program participation can violate HIPAA rules unless they are offered to all "similarly situated individuals" and the reward isn’t predicated on meeting a particular health standard.

HIPAA’s current rule regarding rewards based on health factors sets the value of incentives at a not-to-exceed 20% of the total premium paid by the employer and the employee combined.  The 20% threshold will increase to 30% in 2014 under changes made in the Patient Protection and Affordable Care Act.

As general counsel and secretary for The Vitality Group, Robert Mrizek is responsible for the legal affairs of the company, including compliance with applicable laws. He serves as the company’s privacy officer and chairs the HIPAA compliance committee.

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