• Increasing the group premium or contribution
• Requesting or requiring an individual or family member 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.

Prohibition on Adjusting Group Rates
GINA expands the HIPAA prohibitions against discrimination based on health factors by prohibiting group health plans and health insurance issuers from adjusting premium or contribution amounts for a group health plan or group of similarly situated individuals on the basis of genetic information.

Limitation on Requesting or Requiring Genetic Testing
GINA prohibits plans and issuers from requesting or requiring individuals or their family members to undergo a genetic test. There are two exceptions to this prohibition:

• A health care professional who is providing health care services to an individual may request that the individual undergo a genetic test. 
• A group health plan or group health insurance issuer is permitted to request, but not require, that a participant or beneficiary undergo a genetic test related to certain long-term research studies.

Also, a plan or issuer may obtain and use the results of a genetic test to make a determination regarding payment.

Prohibition on Collection of Genetic Information
GINA prohibits plans or issuers from collecting genetic information, either for underwriting purposes or prior to or in connection with enrollment. Underwriting purposes is defined as including, rules for and determinations of eligibility (including enrollment and continued eligibility), computation of premium or contribution amounts, and application of preexisting condition exclusions.

Under GINA, the definition of underwriting is broader than merely activities relating to rating and pricing a group policy. Underwriting purposes includes changing deductibles or other cost-sharing mechanisms, or providing discounts, rebates, or other premium differential mechanisms in return for activities such as completing a health assessment (HA) or participating in a wellness program.

A wellness program violates GINA when it provides rewards for completing HAs that request genetic information, including family medical history. However, plans and issuers can collect genetic information through HAs in certain circumstances, such as:

• A plan or issuer can collect genetic information through an HA as long as no rewards are provided. The request can not be made prior to or in connection with enrollment. 
• A plan or issuer can also provide rewards for completing an HA as long as the HA does not collect genetic information.

Example: A plan administers two distinct HAs, one that does not request genetic information and one that does. A reward is provided for completing the HA that does not solicit genetic information; the instructions for the other HA make clear that completion of the HA is wholly voluntary and will not affect the reward given for completion of the first HA. The example concludes that neither HA violates the rules against collecting information for underwriting purposes or prior to or in connection with enrollment.

GINA’s Impact on HIPAA Privacy
As mentioned earlier, GINA amends HIPAA to include genetic information in the definition of PHI. The Department of Health and Human Service’s Office of Civil Rights (OCR) has issued proposed regulations which would modify HIPAA’s privacy rules.

One important consequence of GINA’s restrictions on underwriting is that most HIPAA privacy notices will need to be amended to reflect these new limitations. OCR is taking comments on the proposed regulations until Dec. 7, 2009, and is expected to issue final regulations in early 2010. The changes to HIPAA included in the proposed regulations are not effective until after final regulations are released. Watch for another update as soon as OCR releases final rules.

The DOL Final Regulations become applicable to plans and issuers on the first day of the plan year beginning on or after Dec. 7, 2009.