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Employer Wellness Programs: Health Reform
and the Genetic Information
Nondiscrimination Act
Amanda K. Sarata
Analyst in Health Policy and Genetics
August 31, 2009
Congressional Research Service
7-5700
www.crs.gov
R40791
CRS Report for Congress
P
repared for Members and Committees of Congress
c11173008
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
Summary
Health reform is a major issue on the domestic policy agenda of the 111th Congress. Congress has
been considering a number of policy proposals to reform the health delivery system that aim to
improve health care quality, reduce health care costs, and expand access to care. A range of
proposals have targeted reform of the delivery system through an increased focus on prevention
and wellness in an effort to encourage individuals to adopt healthier lifestyles. One prominent
policy lever being considered in some health delivery reform proposals is employer wellness
programs. Employer wellness programs often focus on improving wellness overall, but may
target a specific disease (e.g., diabetes) or behavior (e.g., smoking), may include the provision of
a range of health or other services, and are offered by employers to employees through the
workplace or other setting.
Most if not all employer wellness programs collect medical information from participants.
Programs may request or require participating employees to answer questions about family
history of certain diseases, conditions, or disorders. This information falls under the definition of
genetic information under the Genetic Information Nondiscrimination Act of 2008 (GINA), and
therefore its acquisition and use by employers is strictly protected and is protected differently
than is acquisition of other medical information. Although GINA generally prohibits the
acquisition of genetic information, it does allow for its collection as part of a wellness program,
subject to certain requirements. As Congress considers the role that employer wellness programs
may or can play in reforming the health care system, the potential interaction between GINA and
any wellness program provisions is likely to be assessed.
This report provides an overview of GINA generally, a description of GINA’s statutory exception
allowing for the collection of genetic information pursuant to a wellness program, and a
discussion of some of the key issues that either have arisen or may arise as lawmakers consider
the role of these programs in health reform.
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
Contents
Introduction ................................................................................................................................ 1
Overview of the Genetic Information Nondiscrimination Act of 2008 (GINA)............................. 1
GINA’s Title II Exception for Employer Acquisition of Genetic Information as Part of a
Wellness Program .................................................................................................................... 2
Issues for Consideration .............................................................................................................. 3
Can an Employer Require an Employee to Participate in a Wellness Program Under
GINA? ............................................................................................................................... 3
Can an Employer Require an Employee to Provide Genetic Information as Part of a
Wellness Program Under GINA?........................................................................................ 4
Does GINA Preclude the Use of Financial Incentives to Encourage Participation in
Wellness Programs? ........................................................................................................... 4
Financial Incentives for Participation in a Wellness Program and Underwriting ..................... 5
Contacts
Author Contact Information ........................................................................................................ 6
Congressional Research Service
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
Introduction
Health reform is a major issue on the domestic policy agenda of the 111th Congress. Congress has
been considering a number of policy proposals to reform the health delivery system that aim to
improve health care quality, reduce health care costs, and expand access to care. A range of
proposals have targeted reform of the delivery system through an increased focus on prevention
and wellness in an effort to encourage individuals to adopt healthier lifestyles. One prominent
policy lever being considered in some health delivery reform proposals is employer wellness
programs. Employer wellness programs often focus on improving wellness overall, but may
target a specific disease (e.g., diabetes) or behavior (e.g., smoking), may include the provision of
a range of health or other services, and are offered by employers to employees through the
workplace or other setting. These programs may include the provision of incentives for
participation, ranging from additional paid time off to reduced insurance premium contributions.
Most if not all employer wellness programs collect medical information from participants.
Programs may request or require participating employees to answer questions about family
history of certain diseases, conditions, or disorders. This information falls under the definition of
genetic information under the Genetic Information Nondiscrimination Act of 2008 (GINA), and
therefore its acquisition and use by employers is strictly protected and is protected differently
than is acquisition of other medical information.1 Although GINA generally prohibits the
acquisition of genetic information, it does allow for its collection as part of a wellness program,
subject to certain requirements.
As Congress considers the role that employer wellness programs may or can play in reforming
the health care system, the potential interaction between GINA and any wellness program
provisions is likely to be assessed. Congress may, of course, enact legislation that may in effect or
directly amend the requirements of GINA. This report provides an overview of GINA generally, a
description of GINA’s statutory exception allowing for the collection of genetic information
pursuant to a wellness program, and a discussion of some of the key issues that either have arisen
or may arise as lawmakers consider the role of these programs in health reform.2
Overview of the Genetic Information
Nondiscrimination Act of 2008 (GINA)
On May 21, 2008, the Genetic Information Nondiscrimination Act of 2008 (GINA), referred to by
its sponsors as the first civil rights act of the 21st century, was enacted. GINA, P.L. 110-233,
prohibits discrimination by health insurers and employers based on genetic information. Genetic
information is considered sensitive because it may be predictive and can affect not only an
individual but also family members.3
1 Title II of GINA defines genetic information as “with respect to any individual, information about such individual’s
genetic tests, the genetic tests of family members of such individual, and the manifestation of a disease or disorder in
family members of such individual.” P.L. 110-233, Section 201(4)(A).
2 For a discussion of the legal issues relating to wellness programs, see CRS Report R40661, Wellness Programs:
Selected Legal Issues, coordinated by Nancy Lee Jones.
3 For more information about GINA, please see CRS Report RL34584, The Genetic Information Nondiscrimination Act
(continued...)
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
GINA is divided into two main parts: Title I, which prohibits discrimination by health insurers
based on genetic information, and Title II, which prohibits discrimination in employment based
on genetic information. Title I of GINA amends the Employee Retirement Income Security Act of
1974 (ERISA), the Public Health Services Act (PHSA), and the Internal Revenue Code (IRC),
through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the
Social Security Act, to prohibit health insurers from engaging in genetic discrimination and to
strengthen and clarify existing HIPAA nondiscrimination and portability provisions. In this way,
group plans under ERISA, group and individual plans under the PHSA, Church Plans under the
IRC, and Medigap plans under the SSA are all brought under the jurisdiction of the law. The
complexity of the health care financing system required this multifaceted approach in order to
ensure protection for all individuals, regardless of their coverage arrangement.
Title II of GINA prohibits discrimination in employment because of genetic information and, with
certain exceptions, prohibits an employer from requesting, requiring, or purchasing genetic
information. The law prohibits the use of genetic information in employment decisions—
including hiring, firing, job assignments, and promotions—by employers, unions, employment
agencies, and labor management training programs. On March 2, 2009, the Equal Employment
Opportunity Commission (EEOC) issued proposed regulations for Title II that generally closely
track the statutory language.
GINA’s Title II Exception for Employer Acquisition
of Genetic Information as Part of a Wellness
Program
Although GINA broadly prohibits both the acquisition of genetic information, as well as the use
of genetic information by employers in employment decisions, it does provide for several
exceptions to the prohibition on employer acquisition of this information. Specifically, Title II of
GINA allows employers, employment agencies, labor organizations, and training programs to
acquire genetic information pursuant to the offering of health or genetic services, including
services offered as part of a wellness program.4 The statute states, in pertinent part, “(i)t shall be
an unlawful employment practice for an employer to request, require, or purchase genetic
information with respect to an employee or a family member of the employee except where
health or genetic services are offered by the employer, including such services offered as part of a
wellness program.”5 The exception provided for by this provision is materially identical for
employment agencies, labor organizations, and training programs.
However, employers may collect genetic information as part of a wellness program, pursuant to
this exception, only if they meet three requirements, as specified in statute. These include
• the employee must provide prior, knowing, voluntary and written authorization;
(...continued)
of 2008 (GINA), by Nancy Lee Jones and Amanda K. Sarata.
4 P.L. 110-233. Section 202(b)(2), Section 203(b)(2), Section 204(b)(2), and Section 205(b)(2).
5 P.L. 110-233. Section 202(b)(2)(A).
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
• only the employee and the licensed health care professional or board-certified
genetic counselor involved in providing such services receive individually
identifiable information concerning the results of such services; and
• any individually identifiable genetic information provided in connection with the
health or genetic services provided under this exception is only available for the
purposes of such services and shall not be disclosed to the employer except in
aggregate terms that do not disclose the identity of specific employees.6
The EEOC’s Notice of Proposed Rulemaking (NPRM), released on March 2, 2009, elaborates on
these requirements. Specifically, it states that written authorization must (1) be written so that the
individual from whom the genetic information is being obtained is reasonably likely to
understand the form, (2) describe the type of genetic information that will be obtained and the
general purposes for which it will be used, and (3) describe the restrictions on disclosure of
genetic information.7
Importantly, regardless of how an employer may acquire genetic information (through these
exceptions), the employer is still absolutely prohibited from using the information to discriminate
in employment decisions, such as hiring, firing, and promotion.
Issues for Consideration
A number of issues arise with respect to the interaction between GINA and employer wellness
programs. These include issues relating to the use of financial incentives for participation in
wellness programs; what an employer may require of an employee in terms of either participation
in wellness programs or provision of medical information pursuant to participation in wellness
programs; and the relationship between GINA, underwriting, and financial incentives for
participating in wellness programs.
Can an Employer Require an Employee to Participate in a Wellness
Program Under GINA?
GINA is silent on the issue of whether an employer may require participation in a wellness
program (or if a wellness program may be mandatory). However, the Equal Employment
Opportunity Commission (EEOC) Notice of Proposed Rulemaking (NPRM) states that “the
proposed regulation reiterates the statutory provision [that a covered entity may offer health or
genetic services], but further notes that a wellness program seeking medical information must be
voluntary, which is a requirement set forth in the ADA.”8 In addition, the regulation refers to
“voluntary wellness programs” when discussing allowed exceptions to the prohibition on
employer acquisition of genetic information.
This is potentially an important issue with respect to the scope of the protections offered under
GINA. If an employer were able to both require participation in a wellness program, and require
6 P.L. 110-233. Section 202(b)(2)(B),(C), and (D).
7 74 Federal Register 9068 (March 2, 2009).
8 74 Federal Register 9062 (March 2, 2009).
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
the provision of certain medical and/or genetic information as part of the wellness program, this
would in essence create a requirement that an employee share his or her genetic information with
an employer. This would have the impact of limiting the scope of GINA’s protections, as it would
create an exception to the prohibition on an employer’s acquisition of genetic information that
would not be able to be mitigated by either employee choice or behavior. In addition, if both
participation and provision of genetic information were able to be required, it would conflict with
the statutory requirement under GINA that an employee provide voluntary written authorization
for health or genetic services. If both were required by the employer, by definition, the employee
could not provide voluntary written authorization for health or genetic services.
Can an Employer Require an Employee to Provide Genetic
Information as Part of a Wellness Program Under GINA?
As discussed above, an employer may not require that an employee participate in a wellness
program (or accept health or genetic services) that requires the provision of medical information.
However, an employer may require that, as a condition of participating in a voluntary wellness
program, an employee provide certain medical and/or genetic information. This would comply
with GINA’s protections because if an employee did not want to divulge this information to his
employer, he could opt to not participate in the wellness program. Of course, any provision of
genetic information on the part of an employee, pursuant to participating in a wellness program,
would still have to comply with the three statutory requirements set forth by GINA. The
employee would have to provide voluntary, prior, and knowing written authorization; only the
employee and the licensed health care professional or board-certified genetic counselor involved
in providing the services could have access to individually identifiable information; any
individually identifiable information can not be disclosed to the employer except in aggregate
terms that do not disclose the identity of specific employees.
It may appear that a requirement to provide genetic information pursuant to participation in a
wellness program conflicts with GINA’s requirement that an employee provide voluntary written
authorization for health or genetic services. However, the written authorization would still be
voluntary in as much as the employee would always have the option of not participating in the
wellness program, and thus could voluntarily opt out of providing any genetic information to the
employer.
Does GINA Preclude the Use of Financial Incentives to Encourage
Participation in Wellness Programs?
Nothing in the statutory language of GINA would preclude the use of financial (or other)
incentives by employers for participation in wellness programs. However, the EEOC NPRM
notes that the definition of the term “voluntary,” specifically with respect to financial incentives
for participation in wellness programs, is not a settled matter. Specifically, it states that a wellness
program is voluntary “as long as an employer neither requires participation not penalizes
employees who do not participate.”9 This suggests that it is possible that the interpretation may be
made that a program could not be defined as voluntary if there are any financial incentives
present at all (i.e., if a financial incentive for participation is interpreted as a penalty for not
9 74 Federal Register 9062 (March 2, 2009).
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Employer Wellness Programs and the Genetic Information Nondiscrimination Act of 2008
participating). However, it goes on to note that this definition has not been further developed and
that comments on this specific point are invited.10
Advocates have expressed concern that the scope of GINA may be adversely affected if
employers are allowed to offer any financial incentives for participation in wellness programs.11
For example, the Council for Responsible Genetics maintains that wellness programs may be
considered truly voluntary only if any incentives for participation are prohibited and if voluntary
wellness programs are prohibited from requiring a health risk assessment.
In addition, it is possible that where an employer wellness program requires the provision of
certain genetic information (e.g., family history of cancer or heart disease) that the literal effect of
this could be to discourage participation by those individuals with certain family histories (i.e.,
genetic information). This may occur because although GINA’s protections are in place and
discrimination based on genetic information is prohibited in employment and health insurance,
individuals may not fully trust these protections and may prefer to keep that information private
from their employer, rather than accrue the benefits of participation in the wellness program.
Although this requirement is facially neutral it may in fact discourage the participation of
individuals with certain family histories. Conversely, it is possible that individuals with a certain
family history would prefer to take advantage of the services offered through a wellness program,
and the potential for prevention, and would be more comfortable that the protections in place
under GINA would protect them adequately.
Financial Incentives for Participation in a Wellness Program and
Underwriting
Advocates have expressed concern that if an employer, who is also acting as an insurer, collects
genetic information through a wellness program, and if employers adjust an employee’s premium
contribution based on participation in a wellness program, this may violate GINA’s prohibition on
the use of genetic information in underwriting under Title I of the Act. Specifically, GINA
prohibits “a group health plan, and a health insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request, require, or purchase genetic information
for underwriting purposes.”12 For purposes of Title I of the Act, the term “underwriting purposes”
is defined as
with respect to any group health plan, or health insurance coverage offered in connection
with a group health plan—‘‘(A) rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the plan or coverage; ‘‘(B) the
computation of premium or contribution amounts under the plan or coverage; ‘‘(C) the
application of any pre-existing condition exclusion under the plan or coverage; and ‘‘(D)
other activities related to the creation, renewal, or replacement of a contract of health
insurance or health benefits.13
10 HIPAA regulations address the issue of financial incentives and employer wellness programs. For more information
about this issue, please see CRS Report R40661, Wellness Programs: Selected Legal Issues, coordinated by Nancy Lee
Jones.
11 Genetic Alliance Webinar, May 15, 2009. “Genetic Information Nondiscrimination Act: Title II (Employment).”
Accessed at http://resourcerepository.org/documents/752/ginaimplementation:titleii/#.
12 P.L. 110-233. Section 101(b).
13 P.L. 110-233. Section 101(d).
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If an employer adjusted a premium contribution amount according to participation in a wellness
program but did not utilize collected genetic information in this decision, it would comply with
GINA’s statutory provisions (promulgating regulations have not yet been issued by the
Department of Labor, Treasury or Health and Human Services for Title I). First, if an employer
does collect genetic information as part of a wellness program, making that information available
in an individually identifiable manner to anyone other than the individual, licensed health care
professional, or board-certified genetic counselor would violate GINA. Therefore, an employer
should not have access to this information to begin with, in a manner that would facilitate
underwriting. Second, by definition, in order to violate GINA’s provisions, an employer would
have to use the collected information to determine premium amounts. Simply using the fact of
participation in a wellness program to determine premium contributions does not appear to meet
the definition of “underwriting purposes” under the Act.
Author Contact Information
Amanda K. Sarata
Analyst in Health Policy and Genetics
asarata@crs.loc.gov, 7-7641
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