DMAA Calls for Moratorium on GINA Regulation Implementation

Group Says Oct. 7 Interim Final Rule Would Have 'Dramatic and Unintended Consequences' on Wellness, Chronic Disease Management Programs

WASHINGTON, D.C.—New federal rules on the use of genetic information will severely hinder the ability of businesses, health plans and others to provide wellness and chronic disease management programs, DMAA: The Care Continuum Alliance said today, calling for an immediate moratorium on the new regulation.

An Oct. 7 interim final rule on the "Genetic Information Nondiscrimination Act of 2008" (GINA) will restrict the ability of employers and health plans to create incentives for participation in wellness and disease management programs and weaken a commonly used tool for identifying people who can benefit from such programs, DMAA said.

DMAA said it supports the intent of GINA to prohibit inappropriate use of genetic information in the provision and pricing of health benefits. "However, DMAA believes the definition of 'underwriting' included in the interim final regulations far exceeds Congressional intent and will have dramatic and unintended consequences on programs designed to support at-risk and chronically ill individuals," the association said in a letter to the secretaries of Health and Human Services, Labor and the Treasury. The three departments jointly issued the interim final rule.

DMAA, which represents a large and diverse membership of stakeholders in chronic disease prevention and care, asked the department heads to impose an "immediate moratorium on the implementation and enforcement of these regulations" and also requested creation of a special joint-agency panel to review and assess the impact of the GINA regulations on the operation and effectiveness of wellness and disease management programs.

The final interim regulation broadly defines "underwriting purposes" to mean the rules for determining enrollment in and continued eligibility for health benefits, computation of premium or contribution amounts and application of pre-existing condition exclusions. Under this umbrella, it includes deductible and cost-sharing adjustments, rebates and other incentives for participation in health risk assessment (HRA) and wellness programs. The regulation goes on to prohibit incentives for completing an HRA that seeks genetic information, such as family medical history. Particularly troubling, DMAA said, is the regulation's prohibition on using an HRA that contains genetic information, including family medical history, for matching participants with appropriate disease management programs.

"As written, the interim final rule leaves health plans, employers and others with two equally unattractive options: end incentives for completing an HRA that elicits genetic information (including family medical history) or remove questions about genetic information from the HRA," DMAA wrote. "In the former case, participation in wellness and disease management programs will decline precipitously, as studies have shown incentives significantly improve wellness program participation; in the latter, the effectiveness of the HRA will be severely diluted, as family history and other genetic information are strong indicators of predisposition to a chronic illness."

DMAA President and CEO Tracey Moorhead said the final interim regulation could reverse the recent strong growth of workplace wellness programs and the widely successful use of program participation incentives.

"We know that more than three-quarters of employers offer formal health and wellness programs and that more than 70 percent of those rely on incentives to drive employee participation," she said. "Although well-intentioned, the GINA regulations would have a chilling effect on these programs and on our ability to reach those who could benefit most from chronic disease prevention and care."

DMAA sent a similar letter to Senate leaders asking for clarification of the underwriting definition. In both letters, DMAA said it believes that the GINA interim final rules, by inhibiting wellness and disease management programs, "directly contradict" the Obama administration's stated health care reform goals of improving care quality and reducing costs. As such, the interim final rule "should not be permitted to move forward to implementation or enforcement without closer examination and adherence to original Congressional intent," DMAA said in its letters.

A copy of the letter is available at http://www.dmaa.org/pdf/GINA_IFR_102009FINAL.pdf

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About DMAA: The Care Continuum Alliance
DMAA: The Care Continuum Alliance convenes all stakeholders providing services along the care continuum toward the goal of population health improvement. These care continuum services include strategies such as health and wellness promotion, disease management, and care coordination. DMAA: The Care Continuum Alliance promotes the role of population health improvement in raising the quality of care, improving health outcomes and reducing preventable health care costs for individuals with chronic conditions and those at risk for developing chronic conditions. DMAA's activities in support of these efforts include advocacy, research and the promotion of best practices in care management.

DMAA: The Care Continuum Alliance represents more than 200 corporate and individual stakeholders—including wellness, disease and care management organizations, pharmaceutical manufacturers and benefit managers, health information technology innovators, biotechnology innovators, employers, physicians, nurses and other health care professionals, and researchers and academicians. Visit DMAA on the Web at www.dmaa.org.