Recent regulations under the Genetic Information
Nondiscrimination Act ("GINA") contain broad restrictions
on the collection of family medical history through health risk
assessments and similar arrangements. Although certain narrow
exceptions apply, most employers will have little choice but to
eliminate any questions on family medical history that may appear
in health risk assessments and wellness programs, and to contact
vendors of such arrangements to ensure that such information is not
solicited in any health or wellness material. The regulations are
effective as of the first plan year beginning on and after December
7, 2009 for group health plans that adjust premiums, co-pays, or
deductibles based on completion of health risk assessments that
include questions on family medical history. Penalties for
violation of Title I of GINA include civil penalties under ERISA
and excise taxes under the Internal Revenue Code.
Background
GINA contains two parts. Title I provides that health plans and
health insurers may not use genetic information for underwriting
purposes, request or require genetic information prior to
enrollment, or require an employee or the employee's family
members to take a genetic test. For health plans, Title I is
effective for plan years beginning on and after May 21, 2009
(January 1, 2010, for calendar year health plans – the
regulations are effective for plan years beginning on and after
December 7, 2009 and, thus, are also effective January 1, 2010 for
calendar year plans). The Internal Revenue Service
("IRS"), Department of Labor ("DOL") and
Centers for Medicare & Medicaid Services have regulatory
authority over Title I and they jointly issued the recent interim
regulations.
Title II prohibits employment discrimination based on genetic
information. The Equal Employment Opportunity Commission
("EEOC") has regulatory authority under Title II and has
issued proposed regulations discussed below.
How the Prohibitions Affect Enrollment and Eligibility
The Title I regulations prohibit the collection of genetic
information prior to or in connection with enrollment. Because many
employers ask employees to provide health information in connection
with annual enrollment, employers may need to act now to comply
with the regulations. The regulations under Title I not only
prohibit the collection of family medical history prior to
enrollment, but prohibit the use of such information to determine
eligibility for enrollment in a disease management program. See 26
C.F.R. § 54.9802-3T; 29 C.F.R. § 2590.702-1. The Title I
regulations provide an exception for the "incidental
collection of genetic information." Open-ended questions pose
a problem. If a health risk assessment or similar arrangement
includes an open-ended question that may prompt an individual to
offer family medical history, the information will not be treated
as the incidental collection of genetic information (and may result
in a violation of GINA) unless there is an explicit statement that
genetic information should not be provided.
How the Prohibitions Affect Incentives Offered Through
Health Plans
The Title I regulations view health plans that offer an
incentive (i.e., a reduction in premiums) in connection with the
collection of family medical history in a health risk assessment as
using genetic information for "underwriting purposes."
This is the case even though the incentive is not connected to an
employee's genetic information but rather based on whether the
employee completes a health risk assessment.
Title II and the EEOC Proposed Regulations
Title II of GINA allows employers to request family medical
history in health risk assessments, as long as those arrangements
are not linked to a group health plan through incentives or
otherwise. Such arrangements may only include questions on family
medical history if employees are provided certain written
disclosures and agree in writing to make the information available.
Title II is effective November 21, 2009. The EEOC has regulatory
authority over Title II and has issued proposed regulations.
The EEOC completed final regulations under Title II of GINA several
months ago, but they are being reviewed by the Office of Management
and Budget and have not yet been released. Among the items being
considered by the EEOC is whether an employee's decision to
provide genetic information is "voluntary" if an employer
offers an incentive. Another concern is how they will address the
relationship between Titles I and II of GINA. The Title II proposed
regulations suggest that there is a "firewall" between
Title I and II, and that employers cannot be liable for the
separate penalties under each section for the same act or omission.
See 29 C.F.R. § 1635. This is based on Section 209(a) of GINA.
Hopefully, the EEOC's final regulations will clarify the scope
of the firewall. Employers should review their practices in light
of the proposed regulations to determine if action is
necessary.
GINA and HIPAA Privacy and Security
GINA also provides that genetic information is to be treated as
protected health information under HIPAA. Section 105 of GINA
amends the Social Security Act to apply HIPAA privacy rules to
genetic information. The Department of Health and Human Services
("HHS") has issued proposed regulations that amend the
HIPAA privacy regulations. Employers should consider reviewing
their HIPAA privacy policies with respect to genetic
information.
Conclusion
Many employers are discovering they need to revise their enrollment practices and wellness programs based on the restrictions under Title I regulations. If you have questions about the regulations and the impact on your health plan, please contact the attorney in the Benefits and Compensation practice group with whom you work.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.