Many employers with wellness program that use health risk assessments will have to modify their assessments to avoid running afoul of the Genetic Information Nondiscrimination Act of 2008 (GINA), under final interim regulations set to appear in the Federal Register on October 7, 2009.

Just in time for open enrollment, the Internal Revenue Service (IRS), the Department of Labor (DOL) and the Department of Health and Human Services (HHS) have issued their much-anticipated regulations – effective for plan years starting on and after December 7, 2009 – applying GINA to group health plans and health insurers.

Overview

Title I of GINA generally prohibits plans and insurers from increasing group premiums and contributions based upon genetic information, requesting or requiring genetic testing, and, importantly to employers, collecting “genetic information” either “prior to or in connection with enrollment” or for “underwriting” purposes. These regulations define the scope of these prohibitions, providing many useful examples of health plan provisions that will help employers design their group health plans to avoid violating GINA. The new regulations, which implement Title I of GINA, amend the Health Insurance Portability and Accountability Act (HIPAA) nondiscrimination rules found in the Employee Retirement Income Security Act (ERISA) and the Internal Revenue Code, as well as the HIPAA privacy regulations.

The DOL/IRS/HHS regulations are limited to health plans and health insurers; they do not address employment practices covered under Title II of GINA. Wellness programs that are neither ERISA plans nor group health plans under HIPAA (e.g., because they provide only referral services and no medical care) would not be subject to these regulations, but would have to comply with Title II of GINA and separate Equal Employment Opportunity Commission regulations.

Broad definitions of key terms in the statute and the new regulations make GINA’s prohibitions far-reaching. For example, “genetic information” is defined to include an individual’s genetic tests, requests for – or receipt of – genetic services, and family medical history. As a result, an employee’s genetic information also includes any manifestation of a disease or disorder in the employee’s family members. For this purpose, “family members” include dependents, plus all relatives to the fourth degree, without regard to whether they are related by blood, marriage, or adoption.

Prohibitions on Collecting Genetic Information

GINA prohibits group health plans and insurers from collecting genetic information for underwriting purposes or prior to or in connection with enrollment.

For this purpose, “underwriting” includes any rules for determining eligibility, computing premiums or contributions, and applying preexisting conditions. As a result, the prohibition on collecting genetic information for underwriting is not limited to insurance rating and pricing activities, but would include any changes to deductibles or other cost-sharing and any discounts, rebates, in-kind payments or other methods of altering premiums as a reward (or punishment) for completing a health risk assessment or participating in a wellness program. The new regulations clarify that offering reduced premiums or other rewards for providing genetic information (in this case, the family medical history that often is a routine part of health risk assessments) would be impermissible “underwriting.”

The regulations clarify that the prohibition on collecting genetic information prior to or in connection with enrollment would apply if the plan or insurer collects the information before the individual’s effective date of coverage under the relevant plan. Any renewal of coverage or reenrollment would be treated the same as initial enrollment for this purpose. As a result, while a plan or insurer could collect genetic information after initial enrollment, it could not do so in connection with any annual renewal process where the collection of information affects subsequent enrollment.

If a plan or insurer collects genetic information incidentally along with other information but does not use the information for underwriting, GINA will not be violated so long as the collection of the information was unforeseeable. Employers using enrollment forms or health risk assessments that might be anticipated to elicit family health histories should include special language on the forms warning individuals not to reveal genetic information. This approach will allow the plan to avoid violating GINA when someone incidentally reveals genetic information that was not sought.

Impact on Wellness Programs

The new regulations clarify that wellness programs providing a reward for completing a health risk assessment that collects family medical history generally will violate GINA unless the forms are modified. Even though prior regulations under the HIPAA nondiscrimination rules would have permitted such programs in many cases, particularly where the reward was based upon participation in the wellness program rather than results, under GINA such a program would be an impermissible collection of genetic information for underwriting purposes.

Through a range of examples, though, the new regulations do offer employers options for redesigning their wellness plans to avoid violating GINA. For example, a wellness program that does not collect family medical history will be permissible under GINA, even if it includes participation or results-based rewards (although employers will still need to consider whether it satisfies HIPAA’s requirements). In addition, collecting family medical history but not offering any reward would be allowed, so long as the information is not collected prior to or in connection with enrollment in the wellness program.

Another option the regulations highlight is to request two distinct health risk assessments from employees after (and unrelated to) enrollment in the health plan: one providing a reward for completing a health risk assessment that does not elicit any family medical history or other genetic information, and another purely voluntary and separate health risk assessment that seeks information as to family medical history and genetic testing, to which no reward is tied.

Prohibition on Adjusting Group Rates

While HIPAA’s nondiscrimination provisions already precluded group health plans from discrimination based upon health factors, GINA expands that prohibition. Under GINA, a group health plan cannot adjust premiums or contributions for similarly situated employees based upon genetic information. Previously, plans and insurers could adjust group premiums based upon genetic information (or other health factors), so long as individual premiums were not affected. Under GINA, even if the plan or insurance company has lawfully collected genetic information from an employee or other covered dependents, that information may not be used to set rates.

The new regulations clarify that GINA will not prevent a group health plan or insurer from using claims information or health information from individuals other than genetic information when setting premium and contribution rates. In addition, plans may consider the cost of any covered genetic testing and services when determining pricing for plan coverage.

Limits on Requesting or Requiring Genetic Testing

Although GINA prohibits group health plans and insurance companies from requesting or requiring that an employee or family member undergo genetic testing, the regulations include three exceptions to this rule:  

  • GINA will not prohibit a health care provider who is treating an individual from requesting that the patient undergo genetic testing.
  • The rules permit a plan to obtain genetic test results and use them to make claims payment determinations when it is necessary to do so to determine whether the treatment provided to the patient was medically advisable.
  • Plans can request, but not require, genetic testing in certain very limited circumstances involving research, so long as the results are not used for underwriting, and then only with written notice to the individual that participation is voluntary and will not affect eligibility for benefits, premiums or contributions.

Changes to Privacy Rules

The new GINA regulations also affect the application of HIPAA’s privacy rules to health information held by group health plans and insurers by clarifying that health information includes genetic information. As a result, group health plans and insurers may need to consider further modifications to their Notice of Privacy Practices, as well as their HIPAA privacy policies and procedures to reflect this clarification. Other changes will be needed to these documents under the Health Information Technology for Economic and Clinical Health, or HITECH, Act (for more information, see our August 24, 2009 Benefits eAuthority).

Impact on Employers

Employers that sponsor any group health or wellness plan will need to review their plan documents and administration for compliance with these new rules prior to January 1, 2010 for calendar year plans. Employers will want to work with their administrators and insurers to confirm that they have not impermissibly set rates based upon genetic information and do not use genetic information for any underwriting purposes, including the application of any pre-existing condition exclusion period. In addition, plan sponsors will want to avoid requesting or requiring any genetic testing or genetic information from their employees. Particularly for those employers that are offering wellness programs in connection with upcoming open enrollment seasons, special attention should be given to any health risk assessments or other enrollment forms that collect genetic information, medical history, or any other information that might fall within GINA’s scope.