An interim final rule from the Genetic Information Nondiscrimination Act of 2008 (GINA) could cripple wellness, disease management, and population health management programs, according to DMAA: The Care Continuum Alliance, employer and wellness groups, and health insurers.
The departments of Health and Human Services, Labor, and Treasury offered a joint final regulation of GINA earlier this month that would have unintended consequences, says Tracey Moorhead, president and CEO of DMAA, formerly called the Disease Management Association of America.
President George W. Bush signed GINA into law on May 21, 2008 after the legislation passed Congress with only one opposing vote. The goal behind GINA is to stop discrimination in insurance and employment based on genetic information. Moorhead says the legislation defined "‘underwriting purposes' in a traditional manner," such as computing premium and contribution amounts under a health plan.
However, the joint final regulation goes well beyond that underwriting definition and includes discounts, rebates, payments, and premium differential mechanisms that are paid to people for completing health risk assessments (HRA) or participating in wellness programs, she says.
In announcing the new regulations this month, the three departments trumpeted that GINA will "help ensure that genetic information is not used adversely in determining healthcare coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses."
They added that the interim final rule would not allow group health plans to increase premiums based on a member's genetic information, or deny enrollment, impose pre-existing condition exclusions or conduct "other forms of underwriting based on genetic information," according to the Department of Health and Human Services.
However, Moorhead says the final interim rule goes beyond the intent of the legislation that protected the use of employer wellness programs. It also prohibits collecting family health history prior to enrollment in a group plan and treats family medical history as genetic information.
"We do not believe that Congress intended to have this adverse impact on employer wellness programs. In fact, we believe this is in direct conflict not only with the current administration's goals in terms of prevention and wellness and health promotion that we have heard President Obama repeatedly talk about as a goal for his healthcare reform initiative, but also in direct conflict with the congressional goals for healthcare reform," says Moorhead.
These provisions would not allow health plans, employers, and disease management, wellness, and population health management organizations to use family history data to find at-risk members and could not use incentives to spark them to take part in wellness and disease management programs. The result would be fewer at-risk people involved in prevention programs (more than 70% of employers currently provide incentives to drive employee participation), higher chronic disease rates, and ultimately higher healthcare spending, says Moorhead.
Collecting family history is protected under current HIPAA statutes and the information is used to figure out which members would benefit most from enrolling in a wellness or disease management program. Instead of having that information available, health plans and population health management companies would have to ask members to self-identify, which Moorhead says is not the best way to help members manage their risk factors and chronic conditions.
"Certainly, it is not our intent to utilize health risk assessment-derived information for any purpose other than to promote the health and wellness of these populations. This information is currently protected by HIPAA and we fully support the intent of the GINA legislation and implementing regulation. However, we are very concerned about what we believe are the unintended consequences of this regulatory interpretation," says Moorhead.
If the interim rule remains, John Griffin, chief operating officer at HealthFitness, a Minneapolis-based wellness company, expects companies will remove the family history questions from HRAs. Griffin says HealthFitness' HRA, which is about 80 questions, includes two family medical history questions.
"Almost all HRAs will be intact, but we and everyone I have talked to will remove any family medical history in those HRAs," says Griffin.
Though only two questions, the results allow HealthFitness to reach out to people with family history health problems, such as cancer or heart disease, and target interventions. For instance, HealthFitness may ask women with a family history of breast cancer to get tested earlier than women without breast cancer in their family. Griffin says the interim final rule would have the biggest effect on disease management companies and programs because they deal with chronic disease.
DMAA recently sent a letter to the Senate leaders asking for clarification of the underwriting definition and asked for an immediate moratorium on the GINA regulation implementation.
The interim final rule is scheduled to take effect December 7, but the agencies will accept comments on it until January 5, 2010.