NEW INTERIM FINAL GINA REGULATIONS AFFECT WELLNESS PROGRAMS

Introduction

On October 1, 2009, the Internal Revenue Service, Department of Labor and Department of Health and Human Services jointly released an advanced copy of interim final regulations on the Genetic Information Nondiscrimination Act (“GINA”).  GINA’s group health plan provisions are effective for plan years beginning on or after May 21, 2009.  For calendar year plans the effective date will be January 1, 2010.

These regulations will be effective for group health plans beginning on or after 60 days after the regulations are formally published in the federal register.

The following questions and answers describe what GINA is, what GINA requires or prohibits, what genetic information or testing is and how GINA affects wellness programs.

What is “GINA?”

In regard to group health plans, GINA amended §702 of the Employee Retirement Income Security Act of 1974 (“ERISA”) to:

• Prohibit enrollment restriction and premium adjustment on the basis of genetic information or genetic services;

• Prevent group health plans and insurance companies from requesting or requiring that an individual take a genetic test; and

• Cover all health plans, including those under ERISA, state-regulated plans, and the individual market.

GINA also prohibits:

• Group health plans and health insurers from setting premiums or employee contribution levels based on genetic information;

• Mandatory genetic testing by group health plans or health insurers; and

• Group health plans and health insurers from requesting, requiring, or purchasing genetic information for underwriting purposes; or from seeking such information from individuals who have not yet enrolled.

The group health plan provisions also require amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) privacy regulations to ensure that genetic information is treated as health information, and to prohibit group health plans and health insurers from using or disclosing protected health information (“PHI”) for underwriting purposes.

GINA provides that the prohibition does not: (1) limit the authority of a health care professional to request an individual to undergo a genetic test; or (2) preclude a group health plan from obtaining or using the results of a genetic test in making a determination regarding payment.  GINA requires plans to request only the minimum amount of information necessary to accomplish the intended purpose.

What is Genetic Information?

Genetic information is defined as information about an individual’s genetic tests, information about the genetic tests of an individual’s family members, or information about the manifestation of a disease or disorder in an individual’s family members.  Genetic information includes any request for, or receipt of, genetic services (including genetic testing, counseling, or education), or participation in clinical research which includes such services, by the individual or family member.

Genetic information also includes genetic information of any fetus carried by an individual or family member who is a pregnant woman, as well as genetic information of any embryo legally held by an individual or family member who is utilizing assisted reproductive technology.  Genetic information does not, however, include information about the sex or age of any individual.

What is genetic testing or monitoring?

A genetic test is defined as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.”  This does not include “an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes.”

Genetic monitoring refers to the periodic examination of employees to evaluate acquired modifications to their genetic material, such as chromosomal damage or evidence of increased occurrence of mutations that may have developed during employment due to exposure to toxic substances in the workplace.  In order to qualify as an exception to the prohibitions on genetic monitoring, the purpose of the monitoring must be to identify and control adverse environmental exposures in the workplace.

How does GINA affect wellness programs?

The regulations provide that GINA prohibits group health plans and insurance companies from collecting genetic information, either for underwriting purposes or prior to or in connection with enrollment.  If an individual seeks a benefit under a group health plan, the plan may limit or exclude the benefit based on whether the benefit is medically appropriate (and a determination of whether the benefit is medically appropriate is not within the meaning of underwriting purposes).

The regulations further provide that genetic information is considered collected prior to enrollment if it is collected before the individual’s effective date of coverage under the plan.  If any genetic information is collected after initial enrollment (and not for underwriting purposes) and the individual later drops coverage, but then later reenrolled in the plan, the collection of genetic information after the initial enrollment would not be considered collected prior to reenrollment.  In addition, incidental collections of genetic information that could not be reasonably anticipated do not violate GINA.  But this exception does not apply if it is reasonable to anticipate that genetic information would be provided unless there is an explicit statement that genetic information should not be provided.

The regulations clarify that underwriting purposes include changing deductibles or other cost-sharing mechanisms or providing discounts, rebates, payments in kind or other premium differential mechanisms in return for activities such as completing a health risk assessment (“HRA”) or participating in a wellness program.

Family history or other genetic information can be collected if the purpose of such collection is neither for underwriting purposes nor prior to or in connection with enrollment.  An example of when genetic information can be collected is that genetic information may be collected when making a determination whether a benefit is medically appropriate for the purpose of payment.  The determination of whether the benefit is medically appropriate is not within the meaning of underwriting purposes either.

The regulations also provide that genetic information includes the collection of family medical history.  Any wellness program that provides rewards for completing HRAs that request genetic information, including family medical history, violates the prohibition against requesting genetic information for underwriting purposes.  This is the result even if rewards are not based on the outcome of the assessment.

Genetic information can be collected as long as no rewards are provided (and if the request is not made prior to or in connection with enrollment).  A group health plan or health insurer can provide rewards for completing a HRA as long as the HRA does not collect genetic information.

Conclusion

GINA impacts HRAs in two areas:

• HRAs cannot request genetic information prior to enrollment in the Plan, and

• No rewards or penalties may be offered in conjunction with a HRA that requests genetic information, even if the request is made after the enrollment.

As a result of the regulations, employers and administrators:

• Should review all wellness and disease management plans to determine how a HRA is used and what information is requested;

• Remove any financial incentives or penalties if genetic information is collected in the HRA; and

• Remove any genetic information from the HRA if financial incentives or penalties want to be offered.