Sonnenschein Client Alerts

Summary of the Impact of the GINA Interim Final Regulations on Health Risk Assessments

• Applicability and Effective Date--The interim final regulations implement GINA, and prohibit discrimination based on genetic information in health insurance coverage and group health plans, and apply generally for plan years beginning on or after December 7, 2009.
  
  
• GINA Prohibitions--GINA generally prohibits a group health plan or a health insurance issuer in the group market from:
  • increasing the group premium or contribution amounts based on genetic information;
    
  • requesting or requiring a person to undergo a genetic test; and
    
  • requesting, requiring or purchasing genetic information prior to or in connection with enrollment, or at any time for underwriting purposes.
    
    
• GINA's Expansion of HIPAA--GINA and the interim final regulations expand the prohibitions under the Health Insurance Portability and Accountability Act (HIPAA) against discrimination based on health factors, by prohibiting plans and issuers from adjusting premium or contribution amounts for plans or a group of similarly situated individuals based on genetic information.  This prohibition is distinct from the prohibition on requesting or requiring an individual to undergo a genetic test and the prohibition on collecting genetic information.  Thus, even when a plan or issuer has lawfully obtained results of genetic tests or other genetic information, the plan or issuer is still prohibited from using the information to discriminate.

• Wellness Programs--Wellness programs that provide rewards for completing HRAs that request genetic information, including family medical history, violate the prohibition against requesting genetic information for underwriting purposes.  The regulations do not provide an exception from underwriting for rewards provided by wellness programs, regardless of the amount of the reward.
  
  
• Manifestation of a Disease--The regulations provide that the prohibition on adjusting premiums or contributions based on genetic information does not limit the ability of a plan or issuer to increase the premium or contribution amount for a group health plan based on the manifestation of a disease of an individual enrolled in the plan.  However, a plan or issuer may not use the manifested disease of one individual as genetic information about other group members to further increase the premium or contribution amount.  A plan or issuer is not prohibited from including costs associated with providing benefits for covered genetic tests or genetic services within the costs of providing other benefits in determining premiums or contributions.
  
  
• Limits on Collecting Information for Underwriting or Enrollment--The regulations describe the statutory prohibitions against plans or issuers collecting genetic information, either for underwriting purposes or prior to or in connection with enrollment.  The regulations also clarify that, if an individual seeks a benefit under a plan or coverage, the plan or coverage may limit or exclude the benefit based on whether the benefit is medically appropriate.  Where a person seeks a benefit under a plan requesting genetic information to determine whether the benefit is medically appropriate for purposes of payment is neither for underwriting purposes nor prior to or in connection with enrollment.  If in connection with collecting information, it is reasonable to anticipate that health information will be received and the document explicitly states that genetic information should not be provided, any genetic information provided will be considered within the incidental exception so long as it is not used for underwriting purposes.
  
  
• Meaning of Underwriting Purposes--Underwriting purposes is defined under GINA and the regulations as including, with respect to group health plan coverage, rules for and determinations of eligibility, computation of premium or contribution amounts, and application of preexisting condition exclusions.  Underwriting purposes includes changing deductibles or other cost-sharing mechanisms, or providing discounts, rebates, payments in kind, or other premium differential mechanisms in return for completing an HRA or participating in a wellness program.
  
  
• Requesting Genetic Information Prior to Enrollment--Group health plans are prohibited from requesting genetic information in an HRA prior to the employee's enrollment in the plan.  A plan or issuer can collect genetic information through an HRA as long as no rewards are provided, and if the request is not made prior to or in connection with enrollment.  A plan or issuer can also provide rewards for completing an HRA as long as the HRA does not collect genetic information.
  
  
• Bifurcating HRAs--The regulations permit group health plans to offer two different HRAs - one that offers a reward and does not solicit genetic information (and notes if there is an "open" question that the employee should not provide information relating to family history) and one that asks about family history and genetic information.

What to do now?  These regulations may affect each plan differently, depending on its provisions and coverage.  As employers start to put in order their plan documents, summary plan descriptions, summaries of material modification and enrollment forms for the 2010 plan year, this is the time to:

• Review plans to make sure they are consistent with these plan rules.  Many group health plans request family medical history information to be provided in response to questions on HRAs that are completed by new employees before enrollment in the plan and as part of open enrollment for current employees. Some group health plans provide rewards and incentives to employees who complete HRAs, such as premium reductions, lower deductibles and cash bonus payments.  Compliance review should be conducted for these plans to ensure that the HRAs and any associated policies and procedures comply with GINA's prohibition on using genetic information prior to or in connection with enrollment or for underwriting purposes and to make any necessary changes.  Group health plans that continue to offer a "reward" for participation should consider offering two HRAs to avoid violating these rules.
  
  
• Update training materials and supplement training for Human Resource officers and other key employees with access to protected information and employee data.  It is important for employers to have a record that they offer updated training as the laws change.

For questions, call your regular Sonnenschein contact or any of the following attorneys:

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