On Oct. 1, 2009, the U.S. Departments of Health and Human Services, Labor and the Treasury jointly released an advance copy of the interim final regulations on the Genetic Information Nondiscrimination Act of 2008. The interim final regulations, published in the Federal Register on Oct. 7, clarify several key aspects of GINA as it relates to health risk assessments.
The rules will become effective on Dec. 7, 2009. GINA’s provisions for group health plan are effective for plan years beginning on or after May 21, 2009. Thus, the effective date for calendar year plans is Jan. 1, 2010.
DM programs
GINA prohibits group health plans from (with some very limited exceptions) requesting genetic tests, obtaining genetic information prior to enrollment, and requesting genetic information for underwriting purposes.
Although disease management programs do not typically require genetic testing (although some may require other types of diagnostic testing), some group health plans that include a DM program are designed to require that participants complete an HRA prior to enrollment in the plan.
Without these HRAs, a DM program may not be able to effectively target a particular health problem or health risk for an individual. Even if the HRA is limited to family medical history and includes no specific questions about the individual’s health, requiring such an assessment prior to enrollment would still likely violate GINA, given the Act’s broad definition of “genetic information.”
Under GINA, “genetic information” means information about (i) an individual's “genetic tests”; (ii) the “genetic tests” of “family members” of such individual; and (iii) the “manifestation” of a disease or disorder in the individual’s family members. The regulations explain that a disease or disorder is “manifested” if it has been diagnosed or could reasonably be diagnosed by a health care professional with appropriate training and experience.
Family lineage
“Family members” means the individual’s dependents under the group health plan, as well as any first-, second-, third- or fourth-degree relative of the dependent or the individual. When GINA refers to “family members,” it is not just referring to a family member covered under the plan. The term “family members” encompasses a wide range of lineal and ascending descendants who may or may not be covered under the plan.
The rules explain that for purposes of determining degrees, relatives by affinity (marriage or adoption) are treated the same as relatives by consanguinity (blood relatives) and individuals who are not full-blood relatives (e.g. half sister) is the same as a blood relative. It does not, however, violate GINA to request information regarding the sex or age of an individual.
Plan enrollment and underwriting
GINA prohibits requesting genetic information prior to or in connection with enrollment in the plan for any reason or for “underwriting” purposes at any time. The guidance clarifies that a request is considered “prior to enrollment” if it is made prior to the effective date of coverage in the plan.
Thus, HRAs that are offered prior to or as part of the enrollment process would not be permitted to request genetic information such as family medical history. The regulations further clarify that genetic information requested after enrollment does not violate the rules as long as genetic information obtained after an enrollment does not impact a future enrollment.
Moreover, incidental collections of genetic information that could not be reasonably anticipated do not violate GINA. However, if it is reasonable to anticipate that genetic information will be provided, the incidental collection exception does not apply, unless there is an explicit statement that genetic information should not be provided.
Assuming the HRA is not required prior to enrollment, requesting or requiring a participant to divulge genetic information for “underwriting” purposes is strictly prohibited. The rules clarify that “underwriting” is broadly defined. Generally, underwriting is defined to include rules for or determination of eligibility for benefits or for the computation of premium or contribution amounts under the plan.
Incentives for HRAs
The regulations make clear that “rules for or determination of eligibility” include changes in deductibles or cost sharing mechanisms for completing an HRA and that “computation of premium or contribution amounts” include discounts, rebates, payments and other premium differential mechanisms used for completing the HRA.
In essence, it appears that the regulators intend that HRAs may not provide any “reward, including taxable cash payments” in exchange for completing an HRA that asks for genetic information. Thus, GINA significantly impacts HRAs. Plan sponsors and administrators should review their wellness and disease management practices related to HRAs. Under no circumstances may HRAs request genetic information prior to enrollment in the plan and no rewards (or penalties) may be offered with an HRA that asks for genetic information—even if the request is made after enrollment has occurred.
HRAs that request genetic information may still be used, but there apparently cannot be any financial incentive or penalty related to completing the HRA due to the regulators’ broad definition of underwriting.
Alternatively, HRAs that include a financial incentive or penalty should be “scrubbed” to remove any questions related to genetic information including any questions that could reasonably be anticipated to lead to genetic information (unless the employer instructs the individual not to provide genetic information).
John Hickman can be reached at john.hickman@alston.com and Ashley Gillihan can be reached at ashley.gillihan@alston.com.
Legal Alert: Group health plans will face challenges with GINA
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