[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Rules and Regulations]
[Pages 31143-31159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11557]
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EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
29 CFR Part 1635
RIN 3046-AB02
Genetic Information Nondiscrimination Act
AGENCY: Equal Employment Opportunity Commission.
ACTION: Final rule.
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SUMMARY: The Equal Employment Opportunity Commission (EEOC or
Commission) is issuing a final rule to amend the regulations
implementing Title II of the Genetic Information Nondiscrimination Act
of 2008 as they relate to employer-sponsored wellness programs. This
rule addresses the extent to which an employer may offer an inducement
to an employee for the employee's spouse to provide information about
the spouse's manifestation of disease or disorder as part of a health
risk assessment (HRA) administered in connection with an employer-
sponsored wellness program. Several technical changes to the existing
regulations are included. Published elsewhere in this issue of the
Federal Register, the EEOC also issued a final rule to amend the
regulations and interpretive guidance implementing Title I of the
Americans with Disabilities Act (ADA) that addresses the extent to
which employers may use incentives to encourage employees to
participate in wellness programs that ask them to respond to
disability-related inquiries and/or undergo medical examinations.
DATES: Effective date: This rule is effective July 18, 2016.
Applicability date: This rule is applicable beginning on January 1,
2017.
FOR FURTHER INFORMATION CONTACT: Christopher J. Kuczynski, Assistant
Legal Counsel, at (202) 663-4665 (voice), or Kerry E. Leibig, Senior
Attorney Advisor, at (202) 663-4516 (voice), or (202) 663-7026 (TTY).
(These are not toll free numbers.) Requests for this rule in an
alternative format should be made to the Office of Communications and
Legislative Affairs, at (202) 663-4191 (voice) or (202) 663-4494 (TTY).
(These are not toll free numbers.)
SUPPLEMENTARY INFORMATION: The Commission issued a proposed rule in the
Federal Register on October 30, 2015, for a 60-day notice and comment
period, which was extended for an additional 30 days and ended on
January 28, 2016. After consideration of the public comments, the
Commission has revised portions of both the final rule and the
preamble.
Introduction
Several federal laws govern wellness programs offered by employers.
Employer-sponsored wellness programs must comply with Title II of the
Genetic Information Nondiscrimination Act of 2008 (GINA),\1\ Title I of
the ADA,\2\ and other employment discrimination laws enforced by the
EEOC. Employer-sponsored wellness programs that are part of, or
provided by, a group health plan \3\, or that are provided by a health
insurance issuer offering group health insurance in connection with a
group health plan, must also comply with the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) nondiscrimination
provisions, as amended by the Affordable Care Act, which is enforced by
the Department of Labor (DOL), Department of the Treasury (Treasury),
and Department of Health and Human Services (HHS) (referred to
collectively as the tri-Departments).\4\ This final rule relates
specifically to the requirements of Title II of GINA as they apply to
employer-sponsored wellness programs, though other applicable laws are
discussed in some detail.
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\1\ 42 U.S.C. 2000ff-2000ff-11.
\2\ 42 U.S.C. 12101-12117.
\3\ The term ``group health plan'' includes both insured and
self-insured group health plans, and is used interchangeably with
the terms ``health plan'' and ``the plan'' in this Final Rule.
\4\ The Patient Protection and Affordable Care Act, Public Law
111-148, and the Health Care and Education Reconciliation Act,
Public Law 111-152, are known collectively as the Affordable Care
Act. Section 1201 of the Affordable Care Act amended and moved the
nondiscrimination and wellness provisions of the Public Health
Service (PHS) Act from section 2702 to section 2705 and extended the
nondiscrimination provisions to the individual health insurance
market. The Affordable Care Act also added section 715(a)(1) to the
Employee Retirement Income Security Act (ERISA) and section
9815(a)(1) to the Internal Revenue Code (Code) to incorporate the
provisions of part A of title XXVII of the PHS Act, including PHS
Act section 2705, into ERISA and the Code.
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Congress enacted Title II of GINA to protect job applicants,
current and former employees, labor union members, and apprentices and
trainees from employment discrimination based on their genetic
information.\5\ GINA generally restricts the acquisition and disclosure
of genetic information and prohibits the use of genetic information in
making employment decisions.\6\ The EEOC issued implementing
regulations on November 9, 2010, to provide all persons subject to
Title II of GINA additional guidance with regard to the law's
requirements.\7\
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\5\ Title I of GINA applies to genetic information
discrimination in health coverage (not employment), is applicable to
group health plans and health insurance issuers, and is administered
by the tri-Departments. Under Title I, group health plans may
include, as part of a HRA, questions regarding the manifestation of
a disease or disorder of individuals covered under the plan, but not
genetic information (defined to include genetic test information
about the individual or of family members of the individual or the
manifestation of disease or disorder in family members of the
individual not covered under the plan). See 42 U.S.C. 300gg-
91(d)(16); see also 26 CFR 54.9802-3T(b)(2); 29 CFR 2590.702-
1(b)(2); 45 CFR 146.122(a)(3). This final rule, however, which is
specific to Title II, provides that all health information provided
by a spouse to an employer as part of a HRA is genetic information
with respect to the employee, even where both the employee and
spouse are covered by the plan.
\6\ S. Rep. No. 110-48, at 10 (2007); H.R. Rep. No. 110-28, pt.
3, at 29 (2007).
\7\ See Regulations Under the Genetic Information
Nondiscrimination Act of 2007, 75 FR 68,912 (Nov. 9, 2010) (codified
at 29 CFR pt. 1635).
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Discussion
Title II of GINA prohibits the use of genetic information in making
employment decisions in all circumstances, with no exceptions. It also
restricts employers and other
[[Page 31144]]
entities covered by GINA \8\ from requesting, requiring, or purchasing
genetic information, unless one or more of six narrow exceptions
applies, and strictly limits the disclosure of genetic information by
GINA-covered entities.\9\ The statute and the 2010 Title II final rule
define ``genetic information'' to include: Information about an
individual's genetic tests; information about the genetic tests of a
family member; information about the manifestation of a disease or
disorder in family members of an individual (i.e., family medical
history); \10\ requests for and receipt of genetic services by an
individual or a family member; and genetic information about a fetus
carried by an individual or family member or of an embryo legally held
by the individual or family member using assisted reproductive
technology.\11\ Family members of an individual include someone who is
a dependent of an individual through marriage, birth, adoption, or
placement for adoption and any other individual who is a first-,
second-, third-, or fourth-degree relative of the individual.\12\
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\8\ Unless otherwise noted, the term ``GINA'' refers to Title II
of GINA.
\9\ See 42 U.S.C. 2000ff-2000ff-11; see also 29 CFR 1635.4-
1635.9.
\10\ Congress recognized ``that a family medical history could
be used as a surrogate for genetic traits by a health plan or health
insurance issuer. A consistent history of a heritable disease in a
patient's family may be viewed to indicate that the patient himself
or herself is at increased risk for that disease.'' For that reason,
Congress believed it was important to include family medical history
in the definition of ``genetic information.'' S. Rep. No. 110-48, at
28.
\11\ See 42 U.S.C. 2000ff(4), 2000ff-8(b); see also 29 CFR
1635.3.
\12\ See 42 U.S.C. 2000ff(3)(A) (defining family member for
purposes of GINA to include a dependent within the meaning of
section 701(f)(2) of ERISA); see also 29 CFR 1635.3(a). The
Commission's definition of ``dependent'' is solely for purposes of
interpreting Title II of GINA, and is not relevant to interpreting
the term ``dependent'' under Title I of GINA or under section
701(f)(2) of ERISA and the parallel provisions of the PHS Act and
the Code. See the preamble to the EEOC's regulations implementing
Title II of GINA at 75 FR 68,914, note 5 (and the preamble to the
regulations implementing Title I of GINA at 74 FR 51,664, 51,666)
for additional information.
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There are only six limited circumstances in which an employer \13\
may request, require, or purchase genetic information about an
applicant or employee. One exception permits employers that offer
health or genetic services, including such services offered as part of
voluntary wellness programs,\14\ to request genetic information as part
of these programs, as long as certain specific requirements are
met.\15\ The regulations implementing Title II currently make clear
that one of the requirements is that the employer-sponsored wellness
program cannot condition inducements to employees on the provision of
genetic information.\16\ This requirement is derived from a prohibition
in Title I of GINA (which applies to health plans and health insurance
issuers) against adjusting premium or contribution amounts on the basis
of genetic information.\17\
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\13\ GINA applies to individuals and covered entities in
addition to employees and employers, including employment agencies,
unions and their members, and joint-labor management training and
apprenticeship programs. See 42 U.S.C. 2000ff-1, 2000ff-2, 2000ff-3,
2000ff-4 (describing the prohibited practices of each of these
entities); see also 29 CFR 1635.2(b) (defining ``covered entity''),
1635.4 (describing prohibited practices). For the sake of
readability, and recognizing that employers will be the covered
entity most likely to offer employer-sponsored wellness programs,
the preamble will refer to employers and employees throughout.
\14\ A wellness program, defined as a ``program offered by an
employer that is designed to promote health or prevent disease,'' is
one type of health or genetic service that an employer might offer.
See Section 2705(j)(1)(A) of the PHS Act, as amended by the
Affordable Care Act. A wellness program that provides medical care
(including genetic counseling) may constitute a group health plan
required to comply with section 9802 of the Code, 26 U.S.C. 9802,
section 702 of the ERISA, 29 U.S.C. 1182, or section 2705 of the PHS
Act (i.e., Title I of GINA). Regulations issued under these statutes
address employer-sponsored wellness programs that collect genetic
information. Moreover, employer-sponsored wellness programs that
condition rewards on an individual satisfying a standard related to
a health factor must meet additional requirements. See 26 CFR
54.9802-1(f); 29 CFR 2590.702(f); 45 CFR 146.121(f). As noted above,
the EEOC has also issued a final rule amending the regulations and
interpretive guidance implementing Title I of the ADA as they relate
to employer-sponsored wellness programs. See 29 CFR 1630.14,
published elsewhere in this issue of the Federal Register.
\15\ See 42 U.S.C. 2000ff-1(b)(2), 2000ff-2(b)(2), 2000ff-
3(b)(2), 2000ff-4(b)(2); see also 29 CFR 1635.8(b)(2). Other health
or genetic services include services such as an Employee Assistance
Program or a health clinic that provides flu shots. Under GINA,
employers may request genetic information as part of such health or
genetic services, as long as the requirements of 29 CFR 1635.8(b)(2)
are met.
\16\ See 29 CFR 1635.8(b)(2)(ii). Consistent with the
requirements of paragraph (b)(2)(i) of this section, a covered
entity may not offer an inducement for individuals to provide
genetic information, but may offer inducements for completion of
HRAs that include questions about family medical history or other
genetic information, provided the covered entity makes clear, in
language reasonably likely to be understood by those completing the
HRA, that the inducement will be made available whether or not the
participant answers questions regarding genetic information.
\17\ Title I of GINA applies to genetic information
discrimination in health coverage and not employment. The
Departments responsible for enforcing Title I determined that
permitting employers to condition wellness program inducements on
the provision of genetic information would undermine Title I's
prohibition on adjusting premium or contribution amounts on the
basis of genetic information. For more on the protections provided
by Title I of GINA, see DOL--Employee Benefits Security
Administration, FAQs on the Genetic Information Nondiscrimination
Act (2010), www.dol.gov/ebsa/pdf/faq-GINA.pdf. For a discussion of
how Titles I and II of GINA allow employers and plans to use
financial inducements to promote employee wellness and healthy
lifestyles, see the preamble to the 2010 Title II final rule at 75
FR 68,923 (Nov. 9, 2010).
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Although the EEOC received no comments prior to the publication of
the Title II final rule in 2010 regarding how GINA's restriction on
employers' acquiring genetic information interacts with the practice of
offering employees inducements where a spouse participates in an
employer-sponsored wellness program, this question arose after
publication of the Title II final rule in 2010. Read one way, such a
practice could be interpreted to violate the 29 CFR 1635.8(b)(2)(ii)
prohibition on providing financial inducements in return for an
employee's protected genetic information. This is because information
an employer seeks from a spouse (who is a ``family member'' under GINA
as set forth at 42 U.S.C. 2000ff(4)(a)(ii) and 29 CFR 1635.3(a)(1))
about his or her manifestation of disease or disorder is treated under
GINA as requesting genetic information about the employee. Although the
EEOC's original regulations specifically permitted employers to seek
information about manifestation of diseases or disorders in employees'
family members who are receiving health or genetic services from the
employer, including such services offered as part of a voluntary
employer-sponsored wellness program,\18\ the regulations did not say
whether inducements could be provided in exchange for such information.
The Commission now finalizes the clarification that an employer may, in
certain circumstances, offer an employee limited inducements for the
employee's spouse to provide information about the spouse's
manifestation of disease or disorder as part of a HRA administered in
connection with an employer-sponsored wellness program, provided that
GINA's confidentiality requirements are observed and any information
obtained is not used to discriminate against an employee.\19\ However,
this narrow exception to the general rule that inducements may not be
offered in exchange for an employee's genetic information does not
extend to genetic information about a spouse or to
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information about manifestation of diseases or disorders in, or genetic
information about, an employee's children.
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\18\ See 29 CFR 1635.8(c)(2).
\19\ One industry group argued that using the phrase ``current
or past health status'' to describe the types of questions to
spouses that could include inducements was confusing because not all
information about a spouse's current or past health status meets the
definition of genetic information. In order to clarify that the rule
only applies to questions asked of the spouse that meet the
definition of genetic information, the final rule will replace the
phrase ``current or past health status'' with ``manifestation of
disease or disorder.''
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Background on the Notice of Proposed Rulemaking on GINA and Employer-
Sponsored Wellness Programs
The Commission drafted a Notice of Proposed Rulemaking (NPRM) that
was circulated to the Office of Management and Budget for review
(pursuant to Executive Order 12866) and to federal executive branch
agencies for comment (pursuant to Executive Order 12067).\20\ The NPRM
was then published in the Federal Register on October 30, 2015 for a
60-day public comment period,\21\ which was extended for an additional
30 days \22\ and ended on January 28, 2016.
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\20\ While there are differences between the definitions and
requirements for wellness programs set forth in the Affordable Care
Act, PHS Act, ERISA, the Code, and Title II of GINA, this final rule
is being issued after review by and consultation with the tri-
Departments.
\21\ Genetic Information Nondiscrimination Act, 80 FR 66853
(proposed October 30, 2015) (to be codified at 29 CFR part 1635).
\22\ Genetic Information Nondiscrimination Act, 80 FR 75956
(proposed December, 7, 2015) (to be codified at 29 CFR part 1635).
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The NPRM sought comment on the proposed revisions to the GINA
regulation which:
Clarified that an employer may offer, as part of its
health plan, a limited inducement (in the form of a reward or penalty)
to an employee whose spouse (1) is covered under the employee's health
plan; (2) receives health or genetic services offered by the employer,
including as part of a wellness program; and (3) provides information
about his or her current or past health status.
Explained that the total inducement for an employee and
spouse to participate in an employer-sponsored wellness program that is
part of a group health plan and collects information about the spouse's
current or past health status may not exceed 30 percent of the total
cost of the plan in which the employee and any dependents are enrolled.
Described how inducements must be apportioned between the
employee and spouse.
Explained that inducements may be financial or in kind,
consistent with regulations issued by DOL, HHS, and Treasury to
implement the wellness program provisions in the Affordable Care Act.
For that reason, the proposed rule deleted the term ``financial'' where
it appeared as a modifier for the term ``inducement'' in 29 CFR
1635.8(b)(2).
Explained that any request for current or past health
status information from an employee's spouse must comply in all other
respects with 29 CFR 1635.8(b)(2) concerning requests for genetic
information that are part of voluntary health or genetic services
offered by an employer.
Explained that an employer may not require employees (or
employees' spouses or dependents covered by the employees' health plan)
to agree to the sale, or waive the confidentiality, of their genetic
information as a condition for receiving an inducement or participating
in an employer-sponsored wellness program.
Added an example making it clear that a request for
current or past health status information from an employee's spouse who
is participating in a wellness program does not constitute an unlawful
request for genetic information about the employee.
Made several technical changes to correct a previous
drafting error and to add references, where needed, to HIPAA and the
Affordable Care Act.
Additionally, the Commission specifically sought comments on
several other issues, including:
Whether employers that offer inducements to encourage the
spouses of employees to disclose information about current or past
health status must also offer similar inducements to persons who choose
not to disclose such information but, who instead, provide
certification from a medical professional stating that the spouse is
under the care of a physician and that any medical risks identified by
that physician are under active treatment.
Whether the proposed authorization requirements apply only
to employer-sponsored wellness programs that offer more than de minimis
rewards or penalties to employees whose spouses provide information
about current or past health status as part of a HRA.
Which best practices or procedural safeguards ensure that
employer-sponsored wellness programs are designed to promote health or
prevent disease and do not operate to shift costs to employees with
spouses who have health impairments or stigmatized conditions.
Whether the rule should include more specific guidance to
employers regarding how to implement the requirements of 29 CFR
1635.9(a) for electronically stored records. If so, what procedures are
needed to achieve GINA's goal of ensuring the confidentiality of
genetic information with respect to electronic records stored by
employers.
Whether there are best practices or procedural safeguards
to ensure that information about spouses' current health status is
protected from disclosure.
Whether the regulation should restrict the collection of
any genetic information by an employer-sponsored wellness program to
only the minimum necessary to directly support the specific wellness
activities, interventions, and advice provided through the program--
namely information collected through the program's HRA and biometric
screening. Should programs be prohibited from accessing genetic
information from other sources, such as patient claims data and medical
records data.
Whether employers offer (or are likely to offer in the
future) wellness programs outside of a group health plan or group
health insurance coverage that use inducements to encourage employees'
spouses to provide information about current or past health status as
part of a HRA, and the extent to which the GINA regulations should
allow inducements provided as part of such programs.
Summary of Revisions and Response to Comments
During the 60-day comment period, which was extended by 30 days,
the Commission received 3,003 \23\ comments on the NPRM from a wide
spectrum of stakeholders, including, among others: Individuals,
including individuals with disabilities; disability rights and other
advocacy organizations and their members; members of Congress; employer
associations and industry groups; and health insurance issuers, third
party administrators, and wellness vendors. The comments from
individuals included 2,911 similar, but not uniform, letters--almost
all of which were submitted by a national organization that supports
women and families. Most of the comments (3,000) were submitted through
the United States Government's electronic docket system,
Regulations.gov, under EEOC-2015-0009. The remaining three comments
were mailed or faxed to the Executive Secretariat.
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\23\ One of these comments was withdrawn when the commenter
submitted a ``corrected'' version of the comment.
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The Commission has reviewed and considered each of the comments in
preparing this final rule. The first section of this preamble begins by
clarifying the purpose of this rule. It goes on to address general
comments about the interaction between GINA and the wellness program
provisions of
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HIPAA, as amended by the Affordable Care Act; interaction between GINA
and the ADA; the final rule's applicability date; the rule's treatment
of inducements for information from the children of employees; the
confidentiality protections of the rule; tobacco cessation programs;
and the Commission's burden calculations.
The second section discusses comments submitted in response to
questions the NPRM asked about several issues, as noted above.
The third section addresses comments regarding specific provisions
of the rule.
General Comments
Purpose of the Rule
Many comments submitted by individuals objected to a rule that
would allow employers to charge employees more for benefits based on
the illness of family members, impose stiff penalties on people that do
not measure up to certain health guidelines, allow employers to fire or
otherwise adversely treat employees based on medical information
collected through employer-sponsored wellness programs, and/or allow
``metrics'' that would harm millions of people with disabilities. This
rule, however, is more limited in scope. Instead, it addresses the very
limited question of the extent to which an employer may offer
inducements to an employee for the employee's spouse to provide
information about the spouse's manifestation of disease or disorder as
part of a HRA administered in connection with an employer-sponsored
wellness program. The absolute prohibition on the use of genetic
information to make employment decisions enshrined in Title II of GINA
remains intact, as do the existing protections of Title I of the ADA,
which prohibits discrimination on the basis of disability.
Interaction Between GINA and HIPAA's Wellness Program Provisions
The Commission received comments expressing support for and/or
concerns about employer-sponsored wellness programs. For example, many
commenters stated that although properly designed employer-sponsored
wellness programs have the potential to help employees become healthier
and bring down health care costs, they believe that these programs also
carry serious potential for discrimination in ways already prohibited
by GINA and other civil rights laws, by allowing employers to coerce
employees into providing genetic information (as well as other health
information). Disability rights and health advocacy groups expressed
concern that the EEOC was abandoning its prior position that GINA
prohibits financial inducements in return for all genetic information,
while employer and industry groups commented that the proposed rule's
limitation on inducements was inconsistent with the wellness program
rules under section 2705(j) of the PHS Act. Disability rights groups
further noted that there was no need to alter Title II of GINA's
prohibition on financial incentives in order to conform to laws that
regulate insurance discrimination, given that Title II of GINA is about
employment discrimination, and pointed out that the tri-Department
wellness regulations explicitly state that GINA imposes separate and
additional restrictions.
Although the Commission recognizes that compliance with the
standards in HIPAA, as amended by the Affordable Care Act, is not
determinative of compliance with Title II of GINA,\24\ we believe that
the final rule interprets GINA in a manner that reflects both GINA's
goal of providing strong protections against employment discrimination
based on the possibility that an employee or the employee's family
member may develop a disease or disorder in the future and HIPAA's
provisions promoting wellness programs. Additionally, as we pointed out
in the preamble to the proposed rule, allowing limited inducements for
spouses to provide information about manifested diseases or disorders
(but not their own genetic information) as part of a HRA administered
in connection with an employer-sponsored wellness program is consistent
with HIPAA, as amended by the Affordable Care Act, and Title I of
GINA.\25\ Accordingly, after consideration of all of the comments, the
Commission reaffirms its conclusion that allowing inducements in return
for a spouse providing information about his or her manifestation of
disease and disorder, while limiting inducements to prevent economic
coercion, is the best way to effectuate the purposes of the wellness
provisions of GINA and HIPAA.
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\24\ As the tri-Department wellness regulations acknowledge, the
Affordable Care Act did not amend or overturn GINA, and compliance
with the Affordable Care Act and its implementing regulations is not
determinative of compliance with GINA. See Incentives for
Nondiscriminatory Wellness Programs in Group Health Plans, 78 FR
33158, 33168 (June 3, 2013). A publication issued jointly by the
tri-Departments further explains that a wellness program that
complies with the tri-Departments' wellness program regulations does
not necessarily comply with any other provision of the PHS Act, the
Code, ERISA, (including the Consolidated Omnibus Budget
Reconciliation Act (COBRA) continuation provisions), or any other
state or federal law, such as the ADA, or the privacy and security
obligations of HIPAA, where applicable. Similarly, the fact that an
employer-sponsored wellness program meets the requirements of the
ADA is not determinative of compliance with the PHS Act, ERISA, or
the Code. See DOL--Employee Benefits Security Administration, FAQs
about the Affordable Care Act Implementation (part XXV), Question 2
(2015), http://www.dol.gov/ebsa/pdf/faq-aca25.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/Tri-agency-Wellness-FAQS-4-16-15pdf-AdobeAcrobat-Pro.pdf.
\25\ See 80 FR at 66857, supra note 20.
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Interaction With the ADA and Other Equal Employment Opportunity (EEO)
Laws
The Commission received a number of comments requesting that the
final rule be issued jointly with the final ADA wellness rule, a
suggestion that has been adopted.
Comments raising more substantive concerns about the interaction
between the ADA and GINA focused on the desire for alignment of the
inducement limits available under the statutes, suggesting that the
incentive limit under the ADA, which is based on the total cost of
self-only coverage, be revised to correspond with the inducement limit
proposed in the GINA NPRM, which is based on the total cost of coverage
for the plan in which the employee and any dependents are enrolled. The
Commission declines to adopt this recommendation, however, because the
ADA does not apply to the inducements employer-sponsored wellness
programs offer in connection with spousal participation. As discussed
in more detail below, this final GINA rule will, consistent with the
ADA final rule, limit the maximum share of the inducement attributable
to the employee's participation in an employer-sponsored wellness
program (or multiple employer-sponsored wellness programs that request
such information) to up to 30 percent of the cost of self-only
coverage. Furthermore, the maximum total inducement for a spouse to
provide information about his or her manifestation of disease or
disorder will also be 30 percent of the total cost of (employee) self-
only coverage, so that the combined total inducement will be no more
than twice the cost of 30 percent of self-only coverage.
An advocacy group representing older individuals commented that
protections similar to those proposed in the ADA wellness NPRM against
conditioning access to employer-provided health insurance on the
provision of medical information to an employer-sponsored wellness
program and on retaliation against those who do not participate should
be included in the GINA final
[[Page 31147]]
rule. Protections in the statute and the existing GINA regulations make
clear that an employer may not use genetic information to make
employment decisions, including decisions about benefits.\26\ Both the
statute and the existing regulations also provide that it is unlawful
for an employer to discriminate against any individual because that
individual has opposed any act or practice made unlawful by Title II of
GINA.\27\ We agree, however, that it would improve the final rule
specifically to provide that it is a violation of Title II of GINA for
an employer to deny access to health insurance or any package of health
insurance benefits to an employee and/or his or her family members, or
to retaliate against an employee, based on a spouse's refusal to
provide information about his or her manifestation of disease or
disorder to an employer-sponsored wellness program. We have added
clarification to the final rule at Sec. 1635.8(b)(2)(v).
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\26\ See 42 U.S.C. 2000ff-1(a), 2000ff-2(a), 2000ff-3(a),
2000ff-4(a); 29 CFR 1635.4.
\27\ See 42 U.S.C. 2000ff-8(c); 29 CFR 1635.7.
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Another advocacy group whose mission is to protect the rights of
women and girls asked that the final rule include language making clear
that in addition to complying with the requirements of the final rule,
employers must abide by other nondiscrimination provisions, including,
for example, Title VII of the Civil Rights Act of 1964. We have not
added any language to the final rule on this topic because the existing
regulations already state that nothing contained in Sec. 1635.8(b)(2)
limits the rights or protections of an individual under the ADA, or
other applicable civil rights laws, or under HIPAA, as amended by GINA.
We have made technical revisions to this provision due to the changes
made to the renumbering of other provisions.
Applicability Date
Employer associations and industry groups submitted comments
regarding the effective date of the final rule, recommending that it
allow enough time for employers to bring their wellness programs into
compliance, that it be issued jointly with the ADA wellness rule, and
that it not be applied retroactively. The Commission agrees and
concludes that the provisions of Sec. 1635.8(b)(2)(iii) related to
wellness program inducements will apply only prospectively to employer-
sponsored wellness programs as of the first day of the first plan year
that begins on or after January 1, 2017, for the health plan used to
determine the level of inducement permitted under this regulation. So,
for example, if the plan year for the health plan used to calculate the
permissible inducement limit begins on January 1, 2017, that is the
date on which the provisions of this rule governing inducements apply
to the employer-sponsored wellness program. If the plan year of the
plan used to calculate the level of inducements begins on March 1,
2017, the provisions on inducements will apply to the employer-
sponsored wellness program as of that date. For this purpose, the
second lowest cost Silver Plan is treated as having a calendar year
plan year.
All other provisions of this final rule are clarifications of
existing obligations that apply at, and prior to, issuance of this
final rule.\28\
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\28\ Prior EEOC interpretations set forth in the 2010 final rule
implementing Title II of GINA, Regulations Under the Genetic
Information Nondiscrimination Act of 2007, 75 FR 68912 (Nov. 9,
2010) (codified at 29 CFR part 1635), and the proposed rule on GINA
and employer-sponsored wellness programs, Genetic Information
Nondiscrimination Act, 80 FR 66853 (proposed Oct. 30, 2015) (to be
codified at 29 CFR part 1635), may be considered in determining
whether inducements provided prior to this applicability date for an
employee's spouse or other dependents to provide information about
their manifested diseases or disorders as part of an employer-
sponsored wellness program comply with GINA.
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Prohibition on Inducements for Information From Children of Employees
A number of advocacy groups, employer groups, and industry groups,
in addition to members of Congress, submitted comments concerning the
Commission's proposal that no inducement be permitted in return for the
current or past health status information or the genetic information of
employees' children. Two commenters, pointing to the fact that Title II
of GINA defines ``family members'' to include both spouses and
children, argued that there was no basis for making a distinction
between spouses and children and that, therefore, no inducements should
be permitted in return for current or past health information of
either. Others argued that prohibiting inducements in return for past
or current health information of children conflicts with the Affordable
Care Act's requirement that employers who offer health insurance
coverage to dependents of employees must offer coverage to dependents
up to age 26 and that, therefore, inducements should be permitted in
return for current or past health information from both spouses and
children. Although some commenters agreed with the Commission's
argument that health information about a child is more likely to reveal
genetic information about an employee, one commenter noted that this
does not support the distinction made in the proposed rule because the
same cannot be said of health information about a spouse and adopted
children. Commenters also asked for clarification of whether the
prohibition applied to the current or past health status information of
all children, including children up to the age of 26 who are permitted
to remain on their parents' health plans, or just minor children, with
some urging the Commission to extend the prohibition and others arguing
that children between the ages of 18 and 26 were not in need of this
additional protection and would benefit from participation in an
employer-sponsored wellness program.
The Commission maintains its conclusion that the information about
the manifestation of a disease or disorder in an employee's child can
more easily lead to genetic discrimination against an employee than
information about an employee's spouse. Even where the information
provided concerns an adopted child, it is unlikely that a wellness
program will know whether the child is biological or adopted, and the
information may therefore be used to make predictions about an
employee's health. Consequently, the final rule provides that no
inducements are permitted in return for information about the
manifestation of disease or disorder of an employee's children and
makes no distinction between adult and minor children or between
biological and adopted children.
The fact that the final rule treats health information about
spouses and children differently with respect to wellness program
inducements, however, does not alter the statutory definition of family
member, which includes both spouses and children. Nor does the
distinction, as suggested by some commenters, mean that employers are
prohibited from offering health or genetic services (including
participation in an employer-sponsored wellness program) to an
employee's children on a voluntary basis. They may do so, but may not
offer any inducement in exchange for information about the
manifestation of any disease or disorder in the child.\29\
---------------------------------------------------------------------------
\29\ See 29 CFR 1635.8(b)(2)(A)(iii).
---------------------------------------------------------------------------
The Commission agrees with commenters who suggested that the final
rule should clarify that the prohibition on inducements applies to
adult children. The possibility that
[[Page 31148]]
information about a child could be used to discriminate against an
employee on the basis of genetic information is not diminished by the
age of the child whose information is provided. Therefore, the rule
does not distinguish between minor children and those 18 years of age
and older, and makes explicit that the prohibition extends to adult
children. This clarification is being made to 29 CFR
1635.8(b)(2)(A)(iii).
Confidentiality Protections
The Commission received numerous comments from individuals and
advocacy groups asking that we strengthen the confidentiality
protections of the rule, especially given that the availability of
inducements in return for certain genetic information would likely mean
that more genetic information will end up in the hands of employer-
sponsored wellness programs. Commenters questioned how employer-
sponsored wellness programs would use the information, to whom they
would disclose and/or sell it, and how they would ensure that it
remained confidential. One commenter further noted that many people
erroneously assume that the privacy protections of HIPAA apply to all
employer-sponsored wellness programs and therefore ``may let their
privacy guard down.'' Some of these commenters provided specific
examples of ways in which employer-sponsored wellness programs were not
maintaining, or might not maintain in the future, the confidentiality
of genetic information in their possession--pointing to, for example,
advances in technology that allow for the re-identification and de-
aggregation of unidentifiable and aggregate data that some employer-
sponsored wellness programs are taking or might take advantage of--and/
or made specific suggestions on how GINA's confidentiality protections
could be improved. These suggestions included, among other ideas:
Adding a requirement that individuals have the right to receive copies
of all personal information collected about them as part of an
employer-sponsored wellness program, to challenge the accuracy and
completeness of that information, and to obtain a list of parties with
whom that information was shared and a description of the compensation
or consideration received for that disclosure; providing that covered
entities are strictly liable for any confidentiality breaches and are
not permitted to disclaim liability for harms that result from sharing
data; requiring wellness programs to delete all genetic information
obtained about an individual participating in the employer-sponsored
wellness program if that individual stops participating and requests
that his or her genetic information be deleted; and prohibiting the
storage of individually identifiable information obtained by the
wellness program on work computers, servers, or paper files. Another
commenter noted that the rule should include confidentiality
protections for health information provided by spouses who do not want
that information to fall into the hands of the employee, due, for
example, to domestic violence.
In response, the Commission notes that Title II of GINA and the
existing regulations implementing it include specific confidentiality
provisions which require employers and other covered entities that
possess genetic information to maintain it in medical files (including
where the information exists in electronic forms or files) that are
separate from personnel files and treat such information as a
confidential medical record. These provisions prohibit the disclosure
of genetic information except in six very limited circumstances.\30\
The provision which allows employers to acquire genetic information as
part of health or genetic services such as employer-sponsored wellness
programs further requires that the authorization an individual must
sign explain the restrictions on the disclosure of that information;
that individually identifiable genetic information is provided only to
the individual receiving the services and the licensed health care
professionals or board certified genetic counselors involved in
providing those services; and that any individually identifiable
genetic information is only available for purposes of the health or
genetic services and is not disclosed to the employer except in
aggregate terms.\31\ The Commission intends to continue its vigorous
enforcement of these requirements and believes that they already
provide strong protections against unlawful disclosure of genetic
information provided as part of employer-sponsored wellness
programs.\32\ Some of the ideas offered by advocacy groups as best
practices, such as giving individuals the right to receive copies of
genetic information collected about them, are already requirements of
the regulation.\33\ Although others may make sense as best practices,
such as allowing an individual to challenge the accuracy of genetic
information within the employer's possession, the Commission does not
believe it is necessary to add to the already stringent confidentiality
requirements that exist in the regulations.
---------------------------------------------------------------------------
\30\ See 42 U.S.C. 2000ff-5; 29 CFR 1635.9.
\31\ See 42 U.S.C. 2000ff-1(b)(2), 2000ff-2(b)(2), 2000ff-
3(b)(2), 2000ff-4(b)(2); 29 CFR 1635.8(b)(2)(i).
\32\ Nothing in this rule is intended to affect the ability of a
health oversight agency to receive data under HIPAA. See 45 CFR
164.501 and 164.512(d).
\33\ See 29 CFR 1635.9(b)(1).
---------------------------------------------------------------------------
Tobacco Cessation
Several commenters asked that the Commission clarify its position
on GINA's application to tobacco-related employer-sponsored wellness
programs, such as smoking cessation programs. In response, we reaffirm
that the inducement rules in Sec. 1635.8(b)(2) apply only to health
and genetic services that request genetic information. An employer-
sponsored wellness program does not request genetic information when it
asks the spouse of an employee whether he or she uses tobacco or ceased
using tobacco upon completion of a wellness program or when it requires
a spouse to take a blood test to determine nicotine levels, as these
are not requests for information about the spouse's manifestation of
disease or disorder.
Burden
One commenter asserted that the EEOC underestimated the burden the
proposed rule would impose on employers, arguing that the rule was an
economically significant one that would have an annual effect on the
economy of $100 million or more. Among other things, the commenter
argued that the EEOC underestimated training, compliance review, and
program revision costs; failed to include ``familiarization'' costs;
and failed to provide necessary empirical support for various
conclusions. We disagree.
The proposed rule appropriately estimated the training cost by
using wage data from the Bureau of Labor Statistics indicating a median
$49.41 per hour wage for human resource management professionals.\34\
Although the commenter argues that this rate should be tripled to
reflect ``fully loaded'' hourly rates paid by the government to private
contractors for professional labor, actual hourly wages of human
resource professionals better estimate the economic costs of training.
The fully loaded hourly rate inappropriately includes coverage of the
private contractor's fixed costs and, as a result, will erroneously
bias the estimated economic impact. Costs such
[[Page 31149]]
as a private contractor's office rent and marketing budget are not an
economic impact of the regulation. As such, the estimate of the
marginal economic impact of the regulation excludes firms' fixed costs
because those costs are incurred whether or not the GINA regulation is
revised. Moreover, in most cases, a covered entity's compliance effort
will be conducted by its own human resource management professionals.
The median wage of human resource management professionals therefore
reasonably estimates the economic impact of up to three person-hours of
staff time. The EEOC's estimates of three human resource professionals
per covered entity and one hour per person are cautious and reflect
agency experience and expertise.
---------------------------------------------------------------------------
\34\ The EEOC estimated that a covered entity will train three
human resource management professionals, for one hour each. The
estimated cost was $49.41 per person and $148.23 per covered entity.
---------------------------------------------------------------------------
In response to the commenter's argument that the projected costs
should have included the hiring of a private contractor to provide
training, we reiterate that human resource professionals will be able
to learn what is necessary for compliance with the rule by reading the
EEOC's freely provided technical assistance documents, or participating
in our general or GINA-specific outreach programs, many of which are
free.
Although the commenter asserts that ``great effort'' will be
expended by entities that are not covered by Title II of GINA in
reading the rule to ensure that they are not covered and that these
costs should be included, the proposed regulation does not alter long
established coverage requirements of Title II of GINA, and it is
unlikely that entities that have never before concerned themselves with
compliance with this and other workplace nondiscrimination laws will
now undergo ``great effort'' to ensure that the changes in this rule do
not apply to them.
Finally, we note that the final rule does not require any changes
to employer-sponsored wellness programs that are already in compliance
with Title II of GINA and its existing implementing regulations.
Instead, this rule merely clarifies that offering limited inducements
to spouses is permitted in certain circumstances.
We, therefore, reiterate our conclusion that the rule will not have
an annual effect on the economy of $100 million or more, or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities.
Comments Responding to Questions in the NPRM
One commenter argued that the Commission could not take any action
on issues described only in the portion of the NPRM that asked
questions because the mere posing of a question does not provide the
regulated community with sufficient information to adequately assess
the impact of any eventual proposal as required by the Administrative
Procedure Act (APA). We note, however, that notice is sufficient under
the APA when the final rule ``follow[s] logically'' from the notice so
that ``interested parties [are allowed] a fair opportunity to comment''
upon what becomes the final rule.\35\ The NPRM described the ``subjects
and issues involved'' as required by the APA.\36\ The fact that the
EEOC did receive comments on all seven of the ``subjects and issues''
raised in the questions demonstrates that the notice was adequate.\37\
---------------------------------------------------------------------------
\35\ See Conn. Light & Power v. Nuclear Regulatory Comm'n., 673
F.2d 525, 533 (D.C. Cir. 1982).
\36\ ``The Administrative Procedure Act requires an agency
engaged in informal rule-making to publish a notice of proposed
rule-making in the Federal Register that includes `either the terms
or substance of the proposed rule or a description of the subjects
and issues involved.' '' See id. at 530 (quoting the APA, 5 U.S.C.
553(b)(3)).
\37\ ``The purpose of the comment period is to allow interested
members of the public to communicate information, concerns, and
criticisms to the agency during the rule-making process.'' Id.; see
also City of Stoughton v. EPA, 858 F.2d 747, 753 (D.C. Cir. 1988)
(holding that petitioner could not challenge sufficiency of notice
when petitioner had submitted comments on the issue that petitioner
claimed was inadequately noticed).
---------------------------------------------------------------------------
Certification in Lieu of Spouse Providing Information About
Manifestation of Disease or Disorder
Individuals, including individuals with disabilities and their
advocates, as well as one insurance company and one industry group,
commented that spouses should be allowed to provide a certification
from a medical professional stating that the spouse is under the care
of a physician and that any medical risks identified by that physician
are under active treatment, instead of being required to answer
questions about manifested diseases or disorders. By contrast, most of
the health insurance issuers, industry groups, and employer groups that
commented argued that allowing a spouse to receive the same inducement
for completing such a certification would circumvent the ability of an
employer-sponsored wellness program to assess and mitigate health
risks. Several industry groups also pointed out that this alternative
was not necessary because the tri-Department wellness regulations
already provide a waiver standard that is sufficient to ensure
individuals can earn full inducements even if an impairment makes it
difficult to meet the requirements of a health-contingent wellness
program.
The Commission has decided that although some spouses may already
be aware of their particular risk factors, a general certification or
attestation that they are receiving medical care for those risks would
limit the effectiveness of employer-sponsored wellness programs that
the Affordable Care Act intended to promote. For example, employers may
use aggregate information from HRAs to determine the prevalence of
certain conditions in their workforce and in the families of their
workforce for the purpose of designing specific programs aimed at
improving the health of employees and spouses with those
conditions.\38\ The Commission concludes that protections in the final
rule--such as the requirement that employer-sponsored wellness programs
that collect genetic information be reasonably designed to promote
health and prevent disease and the existing confidentiality
requirements--provide spouses with significant protections without
adopting a medical certification as an alternative to providing
information about the manifestation of disease or disorder.
---------------------------------------------------------------------------
\38\ See, e.g., RAND Health, Workplace Wellness Programs Study
Final Report, 101 (2013), http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf [hereinafter RAND Final
Report].
---------------------------------------------------------------------------
Applying Authorization Requirements Only to Employer-Sponsored Wellness
Programs That Offer More Than De Minimis Inducements for Information
About Spouses' Manifestation of Disease or Disorder
Most of the individuals and advocacy groups who commented on this
issue argued that the authorization requirements should apply to all
employer-sponsored wellness programs, regardless of the level of
inducement offered, in order to provide appropriate protections for
genetic information. Some of these commenters noted that employers have
ways to pressure employees to participate in wellness programs that
have nothing to do with inducements, and others noted that any
ambiguity in the definition of ``de minimis'' could lead to failure to
obtain authorization even when significant inducements are offered.
Although one health insurance company asserted that the authorization
rule should apply to all employer-sponsored wellness programs due to
the administrative complications that different standards
[[Page 31150]]
would cause, most health insurance companies, as well as the employer
associations and industry groups that commented on this issue, went
beyond asserting that there should be a de minimis exception to the
authorization rules and argued for more significant revisions to the
proposed rule. For example, some argued that the EEOC has no statutory
authority to impose a requirement that employers obtain authorization
from spouses, others argued that asking a spouse about his or her own
health was not genetic information and, therefore, not subject to GINA
at all, others argued that a de minimis exception should apply to all
of the requirements of the proposed rule, and still others argued that
the EEOC should consider whether the authorization requirement in
general serves any purpose, given that a family's decision to
participate in an employer-sponsored wellness program should be
sufficient confirmation of voluntariness.
We decline to exclude programs that offer de minimis inducements
from the authorization requirement of the rule. Although commenters
gave examples of some inducements that might be considered de minimis,
no commenters offered a workable principle that could be used as the
basis for defining which inducements are de minimis and which are not.
We suspect that employers' interpretation of the term would vary, and
there is no clear basis on which to establish a threshold for the de
minimis value. We have responded to arguments that the authorization
requirement of the rule be eliminated for various reasons in the in-
depth discussion of the authorization provision, below. (See Comments
Regarding Specific Provisions: Authorization for Collection of Genetic
Information).
Best Practices or Procedural Safeguards To Ensure Employer-Sponsored
Wellness Programs Are Designed To Promote Health or Prevent Disease and
Do Not Operate To Shift Costs
Individuals and advocacy groups responded to this question with the
same suggestions they made for strengthening the definition of
employer-sponsored wellness programs that are ``reasonably designed to
promote health or prevent disease,'' discussed below, raising ideas
such as requiring that employer-sponsored wellness programs be based on
scientifically valid evidence or that they include due process
protections for individuals who claim rules are unfairly applied to
them. Health insurance issuers, employer associations, and industry
groups similarly reasserted the objections they raised in response to
the proposed rule's suggestion that a ``reasonably designed'' standard
be adopted, arguing that existing HIPAA, Affordable Care Act, and GINA
protections are sufficient to protect against discrimination and
unlawful disclosures of genetic information. Some also expressed
frustration with the very idea that employer-sponsored wellness
programs might operate to shift costs in a discriminatory way. The
final rule will not adopt additional protections to safeguard spousal
information or prevent cost-shifting, because existing protections are
sufficient. We will, however, discuss these issues in more detail
below, given that they essentially reiterate comments received in
response to the proposal to adopt a ``reasonably designed'' standard.
(See Comments Regarding Specific Provisions: Health or Genetic Services
Must Be Reasonably Designed).
More Specific Guidance and Procedures on Confidentiality Requirements
for Electronically Stored Records
Several commenters urged the EEOC to convene expert stakeholder
groups or hold public meetings to determine what guidance should be
offered to employers on how to protect electronically stored data. Some
commented that the EEOC should require specific protocols to maximize
the safety of electronically stored genetic information without
providing specifics; others provided suggested restrictions or referred
to security standards such as those being developed by the Precision
Medicine Initiative or those that already exist under the HIPAA Privacy
and Security Rules (some arguing that HIPAA's existing standard already
sufficiently restricts employer-provided wellness programs and others
arguing that rules identical to those under HIPAA should be
specifically applied to all employer-provided wellness programs).
Others argued that since it is unclear whether certain kinds of genetic
information can ever be stored in a way that prevents re-
identification, employers should not be permitted to store such data
(e.g., molecular genetic data).
The goal of the confidentiality and disclosure rules of GINA is to
protect genetic information as required by the statute whether that
information is in paper or electronic format. As noted above, the
regulations already have specific confidentiality provisions that
require employers and other covered entities that possess genetic
information to maintain it in medical files (including where the
information exists in electronic forms or files) that are separate from
personnel files, and treat such information as a confidential medical
record. These provisions prohibit the disclosure of genetic information
except in six very limited circumstances.\39\ The provision that allows
employers to acquire genetic information as part of health or genetic
services such as wellness programs further requires that the
authorization form the employer must provide to an individual to sign
before providing genetic information as part of health or genetic
services must explain the restrictions on the disclosure of that
information. Specifically, the authorization must explain that
individually identifiable genetic information is provided only to the
individual receiving the services and the licensed health care
professionals or board certified genetic counselors involved in
providing those services; and that any individually identifiable
genetic information is only available for purposes of the health or
genetic services and is not disclosed to the employer except in
aggregate terms.\40\ Although we do not believe that it is necessary to
adopt additional protections for electronically stored data, we believe
there are certain best practices that employers may want to consider in
terms of safeguarding all genetic information in their possession.\41\
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\39\ See 42 U.S.C. 2000ff-5(b); 29 CFR 1635.9.
\40\ See 29 CFR 1635.8(b)(2)(i).
\41\ See, e.g., 29 CFR part 1630 app. 1630.14(d)(4)(i) through
(iv): Confidentiality, which describes best practices such as
ensuring that individuals who handle medical information (in this
case, genetic information) that is part of an employee health
program are not responsible for making decisions related to
employment, and that breaches of confidentiality are reported to
affected employees immediately and thoroughly investigated.
---------------------------------------------------------------------------
Best Practices or Procedural Safeguards To Ensure That Information
About Spouses' Manifested Diseases or Disorders Is Protected From
Disclosure
Those who commented on this question raised points quite similar to
those raised about ensuring the confidentiality of electronically
stored data, which are discussed above. Health insurance issuers,
employer associations, and industry groups asserted that existing HIPAA
privacy and security requirements, along with GINA's existing rules,
were sufficient, while advocacy groups provided ideas for strengthening
applicable confidentiality requirements. We reiterate that we do not
believe that additional protections are needed, given GINA's
requirements that genetic information be kept confidential and
disclosed in only six limited circumstances, but urge employers to
consider adopting best practices such as
[[Page 31151]]
those set forth in the appendix accompanying the ADA Final Rule, issued
today. Such practices include adoption and communication of strong
privacy policies, training for individuals who handle confidential
medical information, encryption of electronic files, and policies that
require prompt notification of employees whose information is
compromised if data breaches occur.
Restriction on the Collection of Genetic Information to Only the
Minimum Necessary to Directly Support the Specific Wellness Activities
and Prohibition on Accessing Genetic Information From Other Sources
Individuals and advocacy groups argued that the collection of
genetic information by employer-sponsored wellness programs should be
restricted to the minimum necessary to directly support specific
wellness activities and interventions. Many of these commenters also
urged the EEOC to prohibit employer-sponsored wellness programs from
obtaining genetic information from sources other than voluntarily
submitted health risk assessments and biometric screenings, such as
patient claims data or medical records data. Taking the opposite view,
health insurance issuers, employer associations, and industry groups
argued against adopting any further restrictions on employer-sponsored
wellness programs. Some asserted that information from sources such as
claims data and medical records assists in the development of effective
employer-sponsored wellness programs and that restricting access to it
would impede the design and success of the programs. These commenters
also pointed out that when an employer-sponsored wellness program is
offered as part of a health plan, it may work more optimally to allow
that program to quickly identify people in need of services by using
claims data already being received by the administrator of the health
plan. These and other commenters noted that no additional restrictions
were needed because the existing frameworks of the ADA and GINA
adequately limit the information that may be collected as part of an
employer-sponsored wellness program, while others said that existing
tri-Department wellness rules requiring ``reasonable design'' ensure
that programs are nondiscriminatory. Several of these commenters also
noted that any additional restrictions would unnecessarily stifle
innovation in the design and implementation of employer-sponsored
wellness programs.
The final rule will not include a specific restriction on the
collection of genetic information to only the minimum necessary to
directly support specific employer-sponsored wellness program
activities or a limitation on accessing genetic information from other
sources. The Commission believes that the protections in the final
rule--such as the requirement that employer-sponsored wellness programs
that collect genetic information be reasonably designed to promote
health and prevent disease and the existing confidentiality
requirements--provide significant protections for employees and spouses
without adopting further restrictions or limitations. (See Comments
Regarding Specific Provisions: Health or Genetic Services Must Be
Reasonably Designed).
Employer-Sponsored Wellness Programs Offered Outside of Employer-
Sponsored Group Health Plans
Numerous comments offering a broad range of opinions were submitted
in response to the question in the NPRM asking whether employers offer
or are likely to offer wellness programs outside of a group health plan
or group health insurance coverage that use inducements to encourage
employees' spouses to provide information about current or past health
status as part of a HRA, and the extent to which the GINA regulations
should allow inducements provided as part of such programs. Some
commenters stated many employers already offer wellness programs that
are outside group health plans, while others pointed out that employer-
sponsored wellness programs that offer medical care are group health
programs in themselves. Some argued that the final rule should apply
both to wellness programs that are part of an employer-sponsored health
plan and to wellness programs offered by employers outside such plans,
while others asked the EEOC to clarify what it means for a wellness
program ``to be part of, or provided by, a group health plan.'' Others
argued against applying the final rule to programs offered by employers
that operate outside group health plans (thereby either allowing these
programs to impose higher inducements in return for genetic information
or, in the opinion of one advocacy group, meaning that these programs
would be prohibited from offering inducements for genetic information
at all). One employer association asserted that many of its members
offer inducements for HRAs only under employer-sponsored wellness
programs that are part of a larger group health plan, but that the
breadth of the tri-Department's wellness program rules has the effect
of applying at least some nondiscrimination requirements to nearly all
wellness programs. That commenter concluded that it would be a better
use of the EEOC's time to work on the alignment of Title II of GINA
with the Affordable Care Act, rather than focusing on this issue. One
industry group indicated that the proposed rule failed to provide
guidance for stand-alone wellness programs and argued that anything
less than the 30 percent maximum incentive standard would conflict with
the Affordable Care Act.
Rather than listing factors for determining whether an employer-
sponsored wellness program is part of, or outside of, an employer-
sponsored group health plan, the Commission has decided that all of the
provisions in this rule apply to all employer-sponsored wellness
programs that request genetic information. This means that this rule
applies to employer-sponsored wellness programs that are: Offered only
to spouses of employees enrolled in an employer-sponsored group health
plan; offered to spouses of all employees regardless of whether the
employee or spouse is enrolled in such a plan; or offered as a benefit
of employment to spouses of employees of employers who do not sponsor a
group health plan or group health insurance.
We considered taking the position that employer-sponsored wellness
programs that are not offered through a group health plan and that
request information about the manifestation of disease or disorder from
spouses could not offer any inducements. However, having concluded that
some level of inducement is consistent with other requirements of 29
CFR 1635.8(b)(2), including the requirement that the employer-sponsored
wellness program be ``voluntary,'' where the wellness program is part
of a group health plan, there seemed to be no basis for reaching a
contrary conclusion with respect to employer-sponsored wellness
programs that are outside of a group health plan. At the same time,
allowing unlimited inducements where an employer-sponsored wellness
program is not offered through a group health plan would be
inconsistent with our position that limitations on spousal inducements
are necessary to promote GINA's interest in limiting access to genetic
information and ensuring that inducements are not so high as to be
coercive. Accordingly, as noted below, this rule explains how to
calculate the permissible inducement level for employer-sponsored
wellness programs regardless of whether they are related to a group
health plan.
[[Page 31152]]
Comments Regarding Specific Provisions
Section 1635.8(b)(2)(i)(A) Health or Genetic Services Must Be
Reasonably Designed
The NPRM proposed that employers may request, require, or purchase
genetic information as part of health or genetic services only when
those services, including any acquisition of genetic information that
is part of those services, are reasonably designed to promote health or
prevent disease. Many commenters, including health insurance issuers,
employer associations, industry groups, and a Congressional committee,
urged the EEOC to strike this requirement, noting that it was beyond
the EEOC's authority under GINA to impose a reasonable design
requirement on health and genetic services and that the EEOC should
leave it to the tri-Departments to determine what constitutes a
reasonably designed employer-sponsored wellness program. Some of these
commenters further noted that the proposed requirement was confusing
because even though it sounded very similar, or even identical, to the
corresponding requirement in the Affordable Care Act, it seemed to mean
something different. They urged the Commission to delete the examples
in the preamble and instead make clear that, as with the Affordable
Care Act, satisfaction of the reasonable design standard is based on
all facts and circumstances. Several of these commenters made specific
mention of the preamble's example of a HRA that would not meet the
``reasonably designed'' standard--one that collected information
without providing follow-up information or advice--arguing that this
conclusion did not conform to the Affordable Care Act's definition and
that it is not always appropriate to provide follow-up information.
Some further argued that if the Commission was going to rely on
examples to explain the standard, it should put the examples in the
regulation itself and make them more detailed.
Individuals and advocacy groups, on the other hand, argued that the
new standard was not sufficiently rigorous and that it should be based
on clinical guidelines or national standards, or that there should be a
stronger connection between the content of a HRA and the development of
specific disease management programs. Some argued, for example, for a
requirement that employer-sponsored wellness programs collect no more
than the minimum necessary information from spouses directly linked to
specific program services in order to meet the ``reasonably designed''
standard and/or that employer-sponsored wellness programs be required
to provide scientific evidence that demonstrates that the program
improves health or prevents disease. Others noted that the standard as
described has virtually no meaning and will allow employers to decide
for themselves what is ``reasonable.''
The final rule acknowledges that satisfaction of the ``reasonably
designed'' standard must be determined by examining all of the relevant
facts and circumstances and otherwise retains the requirement in the
NPRM that employers may request, require, or purchase genetic
information as part of health or genetic services only when those
services, including any acquisition of genetic information that is part
of those services, are reasonably designed to promote health or prevent
disease. As noted in the NPRM, in order to meet this standard, the
program must have a reasonable chance of improving the health of, or
preventing disease in, participating individuals, and must not be
overly burdensome, a subterfuge for violating Title II of GINA or other
laws prohibiting employment discrimination, or highly suspect in the
method chosen to promote health or prevent disease. The examples in the
preamble to the proposed rule were intended simply to illustrate how
this standard works. We now clarify, in agreement with several comments
about one of these examples, that programs consisting of a measurement,
test, screening, or collection of health-related information without
providing results, follow-up information, or advice designed to improve
the participant's health would not be reasonably designed to promote
health or prevent disease, unless the collected information actually is
used to design a program that addresses at least a subset of conditions
identified. Additionally, we would consider a program to not be
reasonably designed to promote health or prevent disease if it imposes,
as a condition of obtaining a reward, an overly burdensome amount of
time for participation, requires unreasonably intrusive procedures, or
places significant costs related to medical examinations on employees.
We also would not consider a program to be reasonably designed to
promote health or prevent disease if it exists merely to shift costs
from the covered entity to targeted employees based on their health or
if the employer is only using the program for data collection or to try
to determine its future health costs. Additionally, under these rules,
an employer-sponsored wellness program is not reasonably designed if it
penalizes an employee because a spouse's manifestation of disease or
disorder prevents or inhibits the spouse from participating or from
achieving a certain health outcome. For example, an employer may not
deny an employee an inducement for participation of either the employee
or the spouse in an employer-sponsored wellness program because the
employee's spouse has blood pressure, a cholesterol level, or a blood
glucose level that the employer considers too high.
The Commission believes that because the requirement that an
employer-sponsored wellness program be ``reasonably designed to promote
health or prevent disease'' is a standard with which health plans are
now sufficiently familiar, it is reasonable to apply that standard
under GINA to employers that sponsor wellness programs. For
consistency, this same requirement, with the same examples, has
recently been adopted under the ADA.\42\ Although the standard is less
stringent than some commenters would prefer, the Commission believes it
provides a sufficient level of protection against the misuse of
employee genetic information while providing a degree of flexibility in
designing wellness programs.
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\42\ See 29 CFR 1630.14(d)(1); published elsewhere in this issue
of the Federal Register.
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Section 1635.8(b)(2)(iii)
When an Inducement May Be Offered
As noted in the general comments section, above, numerous
individuals and advocacy groups urged the Commission to abandon the
position set forth in the proposed rule that employers may offer
limited inducements when a spouse who receives genetic services offered
by an employer provides information about his or her current or past
health status information as part of a HRA. These commenters, as well
as some members of Congress, argued that the absolute prohibition on
financial inducements set forth in the existing GINA regulations should
be reaffirmed, arguing that allowing employer-sponsored wellness
programs to offer inducements in exchange for spouses to provide
information about their current or past health status would be coercive
and would substantially weaken GINA's protections. Several industry and
employer groups, on the other hand, expressed support for the proposed
rule's clarification that GINA does not preclude inducements for
spouses for
[[Page 31153]]
completion of HRAs when the requirements of Sec. 1635.8(b)(2)(i) were
met, while expressing deep dissatisfaction with the limitations on
those inducements. As noted above, one industry group argued that use
of the phrase ``current or past health status'' in describing the types
of questions to spouses that could include inducements was confusing
because not all information about a spouse's current or past health
status meets the definition of genetic information. For example, some
might consider questions about height, weight, and exercise regimes to
be questions about ``current health status,'' although such questions
asked of an employee's spouse are not requests for genetic information
under GINA.
The Commission retains the NPRM's requirements that, consistent
with the requirements of Sec. 1635.8(b)(2)(i) and (ii), a covered
entity may offer an inducement to an employee whose spouse provides
information about the spouse's own current or past health status as
part of a HRA. In order to clarify that the rule only applies to
questions asked of the spouse that meet the definition of genetic
information, the final rule will replace the phrase ``current or past
health status'' with ``manifestation of disease or disorder.''
Moreover, as discussed in detail above, because the final rule will
apply not only to employer-sponsored wellness programs that are part of
group health plans, but to all wellness programs offered by employers,
the language of the final rule at Sec. 1635.8(b)(2)(iii) will be
revised to eliminate references to the employer's health plan. (See
Comments Responding to Questions: Wellness Programs Offered Outside of
Employer-Sponsored Group Health Plans.) The final rule will also
explain how inducement limits are to be calculated in situations where
participation in an employer-sponsored wellness program does not depend
on enrollment in a particular group health plan, and in situations
where an employer does not offer a group health plan but still wants to
offer inducements for employees and their spouses to participate in
wellness programs. Finally, the final rule retains the requirement that
no inducement may be offered in return for the spouse providing his or
her own genetic information, including results of his or her genetic
tests, as well as the prohibition on providing inducements in return
for health information about an employee's children.\43\ (See General
Comments: Prohibition on Inducements for Information From Children of
Employees.)
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\43\ 29 CFR 1635.8(b)(2)(i)(B). Title I of GINA specifically
prohibits a group health plan and a health insurance issuer in the
group or individual market from collecting (including requesting,
requiring or purchasing) genetic information prior to or in
connection with enrollment in health coverage or for underwriting
purposes. See 26 CFR 54.9802-3T(b), (d); 29 CFR 2590.702-1(b), (d);
45 CFR 146.122(b), (d); 45 CFR 147.110; 45 CFR 148.180(b), (d).
``Underwriting purposes'' includes rules for eligibility for
benefits and the computation of premium or contribution amounts
under the plan or coverage including any discounts, rebates,
payments in kind, or other premium differential mechanisms in return
for activities such as completing a HRA or participating in a
wellness program. See 26 CFR 54.9802-3T(d)(1)(ii); 29 CFR 2590.702-
1(d)(1)(ii); 45 CFR 146.122(d)(1)(ii); 45 CFR 148.180(f)(1)(ii).
Consequently, employer-sponsored wellness programs that provide
rewards for completing HRAs that request a plan participant's
genetic information, including family medical history, violate the
prohibition against requesting genetic information for underwriting
purposes, regardless of whether the plan participant provides
authorization. Under Title I of GINA, a group health plan and a
health insurance issuer in the group or individual market may
request genetic information through a HRA as long as the request is
not in connection with enrollment and no rewards are provided.
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Level of Inducement That May Be Offered
The Commission received numerous comments on this provision of the
proposed rule. As stated in the general comments section of this
preamble, individuals and health advocacy groups said that the proposed
rule was based on the erroneous assumption that the GINA rule must be
``conformed'' to provisions of the Affordable Care Act concerning
employer-sponsored wellness programs. These and other commenters,
including some members of Congress, commented that allowing employer-
sponsored wellness programs to offer inducements up to 30 percent in
exchange for spouses to provide information about their current or past
health status would be coercive and would substantially weaken GINA's
protection and urged the Commission to strike this proposal and
reaffirm that inducements are not permitted in return for genetic
information. Other advocacy groups argued that allowing inducements for
spousal information would lead to conflict within families, worsening
the mental and physical health of family members when, for example, an
employee and spouse disagree about whether the spouse will provide the
information needed to obtain a reward or avoid a penalty. One commenter
noted that a rule that permits employers to increase the amount an
employee pays for health insurance by as much as 30 percent of the
total cost of coverage if the employee or the employee's spouse fails
to provide certain health information would lead some to forego
employer-provided health insurance and thus increase the pool of
families without ``good'' health insurance coverage. Employer and
industry groups, however, commented that the EEOC should align the
inducement limits for employer-sponsored wellness programs with the
inducement limits established in the tri-Department wellness
regulations. One industry group asserted that requests to an individual
for information about his or her own past or current health status is
not genetic information (except for genetic test results) and that the
EEOC therefore did not have authority under GINA to adopt requirements
with respect to inducements for this information. Another industry
group, after expressing strong disapproval of the proposed rule's
inducement limitation, went on to provide suggestions for improving the
description of that limitation if the Commission were to adopt it,
suggesting, for example, that certain provisions in the regulatory
language be moved. Although some of these commenters appreciated that
the proposed rule based the inducement limit on the total cost of
coverage for the plan in which the employee and any dependents are
enrolled, employer associations and industry groups generally asserted
that the inducement limits should conform to those established by the
tri-Department wellness regulations, particularly the lack of incentive
limits on participatory programs.
Most individuals and advocacy groups that submitted comments did
not comment on the proposed rule's discussion of how inducements should
be apportioned. Two groups that did comment indicated their support for
the idea, assuming that the EEOC was going to move forward with the
proposal to allow inducements. In contrast, numerous health insurance
issuers, employer associations, industry groups, as well as a
Congressional committee and various United States Senators, commented
that the apportionment rule should be eliminated, arguing that it was
administratively complicated and/or that it conflicts with the tri-
Departments' wellness regulations, which does not require
apportionment. Many of these commenters also pointed out that the
apportionment rule conflicts with the general practice of providing an
equal inducement to an employee and a spouse when both participate in
an employer-sponsored wellness program and that encouraging a larger
inducement for spouses was arbitrary, implied that the spouse's
achievement of a health goal is more
[[Page 31154]]
valuable than the employee's equal accomplishment, and/or conflicted
with the idea of a reasonably designed wellness program. One group
requested that, if the EEOC were to move forward with apportionment
rules, the rule clarify that the amount of the inducement attributable
to the spouse does not have to be paid directly to the spouse but,
instead, could be paid as part of a premium reduction or in any other
way that the other portion of the inducement was being paid.
The Commission agrees that the proposed rule's apportionment
standards, which would have permitted a larger inducement to the spouse
for providing similar information to that which the employee provided,
is overly complicated and sends the wrong message about the value of
employer-sponsored wellness programs for each participating individual.
Moreover, we determined, in developing the final ADA rule on employer-
sponsored wellness programs, that incentives in excess of 30 percent of
the cost of self-only coverage offered in exchange for an employee
answering disability-related questions or taking medical examinations
as part of a wellness program would be coercive. We see no reason for
adopting a different threshold where the employee's spouse is the
individual whose health information is being sought. Consequently, this
final rule states that when an employee and the employee's spouse are
given the opportunity to enroll in an employer-sponsored wellness
program, the inducement to each may not exceed 30 percent of the total
cost of (1) self-only coverage under the group health plan in which the
employee is enrolled (including both employee and employer cost), if
enrollment in the plan is a condition for participation in the wellness
program; (2) self-only coverage under the group health plan offered by
the employer (including both employee and employer cost), where the
employer offers a single group health plan, but participation in a
wellness program does not depend on the employee's or spouse's
enrollment in that plan; (3) the lowest cost self-only coverage under a
major medical group health plan offered by the employer (including both
employee and employer cost), where the employer has more than one group
health plan, but enrollment in a particular plan is not a condition for
participating in the wellness program; or (4) the second lowest cost
Silver Plan \44\ available on the Exchange in the location that the
employer identifies as its principal place of business if the employer
offers no group health plan. In this last instance, the maximum
inducement to the employee and the spouse is equal to 30 percent of the
cost of covering an individual who is a 40-year-old non-smoker. Thus,
the amount of the inducement available to the spouse cannot exceed the
amount an employer may offer to an employee, under the ADA, to
participate in a wellness program that includes disability-related
questions or a medical examination.
---------------------------------------------------------------------------
\44\ There are four ``metal'' categories of health plans in the
Exchanges established under the Affordable Care Act: Bronze, Silver,
Gold, and Platinum. See How To Pick a Health Insurance Plan: The
``Metal Categories'', Healthcare.gov, https://www.healthcare.gov/choose-a-plan/plans-categories (last visited March 29, 2016).
---------------------------------------------------------------------------
The final rule includes examples explaining how the inducement
limits are to be calculated. For example, if an employee is enrolled in
a group health plan through the employer at a total cost (taking into
account both employer and employee contributions towards the cost of
coverage) of $14,000 for family coverage, that plan has a self-only
option for a total cost of $6,000, and the employer provides the option
of participating in a wellness program to the employee and spouse if
they participate in the plan, the employer may not offer more than
$1,800 to the employee and $1,800 to the spouse. If participation in a
particular group health plan is not required for the employee and
spouse to earn an inducement and the employer has only one group health
plan under which self-only coverage costs $7,000, the employee and the
spouse can each get an inducement of up to $2,100. If participation in
a particular group health plan is not required for the employee and the
spouse to earn an inducement and the employer has more than one group
health plan and self-only coverage under the major medical group health
plans range in cost from $5,000 to $8,000, the employee and spouse can
each get an inducement of up to $1,500. Finally, if the employer offers
no group health plan at all and the second lowest-cost Silver Plan
available through the state or federal health care Exchange established
under the Affordable Care Act in the location that the employer
identifies as its principal place of business would cost a 40-year-old
non-smoker $4,000, the maximum inducement the employer could offer the
employee and the spouse would be no more than $1,200 each to answer
questions about their current health or to take a medical examination
as part of a wellness program.
As noted in the ADA final rule, the Commission has concluded that
the employer's lowest total cost self-only coverage under a major
medical group health plan is an appropriate benchmark for establishing
the inducement limit where an employer has more than one group health
plan and participation in an employer-sponsored wellness program does
not depend on enrollment in any particular plan for two reasons. First,
it offers employers predictability and administrative efficiency in
complying with the rule. Second, the rule is consistent with the
Commission's objective of ensuring that inducements in return for a
spouse providing information about his or her manifestation of disease
or disorder are not coercive.
The second lowest cost Silver Plan available on the Exchange in the
location that the employer identifies as its principal place of
business is used as a benchmark for determining the amount of an
eligible individual's premium tax credit for purchasing health
insurance on the Exchange.\45\ This is the most popular plan on the
Exchanges, and information about its costs for individuals who are 40
years old and non-smokers is available to the public.\46\ Additionally,
because the Silver Plan typically is neither the least nor the most
expensive plan available on the Exchanges, inducement limits that are
tied to its costs may promote participation in wellness programs while
not being so high as to be coercive.
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\45\ See 26 U.S.C. 36B(b)(2).
\46\ See, e.g., HHS, Health Insurance Marketplaces 2015 Open
Enrollment Period: March Enrollment Report (2015), https://aspe.hhs.gov/sites/default/files/pdf/83656/ib_2015mar_enrollment.pdf
(HHS report covering marketplace enrollment from November 15, 2014
through February 15, 2015, indicating that, based on enrollment
through all marketplaces, 67 percent of people who selected a
marketplace plan selected Silver.)
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Revisions will be made to Sec. 1635.8(b)(2)(iii) to correspond to
these changes. We also clarify that the portion of the inducement
attributable to the spouse's provision of information about his or her
manifestation of disease or disorder need not be paid directly to the
spouse, but may be paid in whatever way the remaining portion of the
inducement is made such as, for example, as part of a reduction in
premium.
Authorization for Collection of Genetic Information
Although numerous health and other advocacy groups agreed that
authorization is a much needed component of employer-sponsored wellness
programs that collect genetic
[[Page 31155]]
information, they went on to argue that the authorization requirements
of GINA should be strengthened. Some noted that the authorization forms
currently in use by wellness vendors tend to use arcane language, are
insufficiently understood, and/or on occasion are hidden in obscure
links that few people read. Others suggested that in order to truly
ensure that participation in an employer-sponsored wellness program
that collects genetic information is voluntary, authorization
requirements should allow a participant who indicates that his or her
participation is not voluntary to obtain the reward or avoid the
penalty even if his or her spouse does not provide the requested
information. Several advocacy groups suggested that the Commission
provide model authorization forms and notices. While some health
insurance issuers and industry groups agreed that the Commission should
provide model language that would satisfy the authorization
requirements, these commenters, as well as employer groups, generally
urged the Commission to strike or limit the authorization requirement.
Some argued that the Commission did not have the authority to require
spouses to provide authorization because the statutory language
requires that prior, knowing, written, and voluntary authorization be
provided by the employee, not by other individuals. Others noted that
requiring multiple authorization forms would unduly complicate the
operation of employer-sponsored wellness programs and that a single
authorization completed by the employee should be sufficient.
This final rule adds no new notice or authorization requirements.
It reaffirms that when an employer offers an employee an inducement in
return for his or her spouse's providing information about the spouse's
manifestation of disease or disorder as part of a HRA, the HRA (which
may include a medical questionnaire, a medical examination, or both),
must otherwise comply with Sec. 1635.8(b)(2)(i) in the same manner as
if completed by the employee, including the requirement that the spouse
provide prior knowing, voluntary, and written authorization when the
spouse is providing his or her own genetic information, and the
requirement that the authorization form describe the confidentiality
protections and restrictions on the disclosure of genetic information.
The employer also must obtain authorization from the spouse when
collecting information about the spouse's manifestation of disease or
disorder, although a separate authorization for the acquisition of this
information from the employee is not necessary.
The Commission believes that GINA's existing authorization
requirements prohibit many of the practices about which advocacy groups
expressed concern. For example, these requirements already prohibit an
employer-sponsored wellness program that collects genetic information
from using an authorization notice that uses arcane legal language or
is otherwise difficult to understand.\47\ Moreover, although it is true
that GINA's statutory language, at 42 U.S.C. 2000ff-1(b)(2)(B), states
that the ``employee'' must provide prior, knowing, voluntary, and
written authorization, the EEOC's original implementing regulations use
the broader term ``individual'' when describing the prior, knowing,
voluntary, and written authorization requirement.\48\ As noted in the
preamble to the proposed rule, the Commission believes that
``individual'' best reflects the intent of Congress, especially when
considering the provisions in 42 U.S.C. 2000ff-1(b), which prohibit
employers from requesting, requiring, or purchasing genetic information
about both employees and their family members with limited exceptions,
and the general purpose of the statute.
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\47\ The GINA notice and authorization requirement, which was
included in the EEOC's regulations pursuant to a specific statutory
requirement, see 42 U.S.C. 2000ff-1(b)(2)(B), is only met if the
covered entity uses an authorization form that (1) is written so
that the individual from whom the genetic information is being
obtained is reasonably likely to understand it; (2) describes the
type of genetic information that will be obtained and the general
purpose for which it will be used; and (3) describes the
restrictions on disclosure of genetic information. The GINA notice
and authorization rule also requires that individually identifiable
genetic information is provided only to the individual (or family
member if the family member is receiving genetic services) and the
licensed health care professionals or board certified genetic
counselors involved in providing such services, and is not
accessible to managers, supervisors, or others who make employment
decisions, or to anyone else in the workplace; and, finally, that
any individually identifiable genetic information provided under 29
CFR 1635.8(b)(2) is only available for purposes of such services and
is not disclosed to the covered entity except in aggregate terms
that do not disclose the identity of specific individuals. See 29
CFR 1635.8(b)(2)(i).
\48\ See 29 CFR 1635.8(b)(2)(i)(B).
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Section 1635.8(b)(2)(vi) Prohibition on Conditioning Participation in
an Employer-Sponsored Wellness Program on Agreeing To Sale of Genetic
Information or Waiving Confidentiality
Individuals and advocacy groups that commented on this portion of
the proposed rule supported it but requested that it be strengthened.
They argued, for example, that the provision should be expanded to not
only prohibit conditioning participation in an employer-sponsored
wellness program on agreeing to the sale of genetic information, but
also other forms of sharing genetic information such as exchanges and
transfers. Others argued that the provision should state that harm will
be presumed from unauthorized disclosure of genetic information and
that, if sharing does occur, employers should be required to reveal the
identity of those with whom they shared the genetic information. One
industry group expressed support for the notion that genetic
information, as one type of protected health information, should not be
sold, but noted that this did not necessarily apply to de-identified or
aggregate data.
The Commission agrees that this prohibition should be expanded. The
final rule therefore prohibits a covered entity from conditioning
participation in an employer-sponsored wellness program or an
inducement on an employee, an employee's spouse, or other covered
dependent agreeing to the sale, exchange, sharing, transfer, or other
disclosure of genetic information (except to the extent permitted by
paragraph 1635.8(b)(2)(i)(D)), or waiving protections provided under
Sec. 1635.9. As explained above, however, the Commission does not
believe that any further changes are needed because the confidentiality
protections of Sec. 1635.9, as well as the specific disclosure rules
that apply to health and genetic services set forth at Sec.
1635.8(b)(2), provide strong protections against disclosure of genetic
information. (See General Comments: Confidentiality Provisions.)
Section 1635.8(c)(2) Employer Permitted To Seek Medical Information
Few people commented on the new example the EEOC added to this
section of the rule. Two industry groups that did comment supported the
EEOC's acknowledgement that employers may ask for information about the
manifestation of disease, disorder, or pathological condition of a
family member if that individual is receiving genetic services on a
voluntary basis. However, comments indicated that clarification is
needed for this example to be understood. As noted in the preamble to
the proposed rule, this provision cross-references 29 CFR 1635.8(b)(2)
to make clear that an employer may request information about the
manifestation of disease, disorder, or pathological condition of a
family member who is participating in voluntary genetic services only
when all of the requirements for seeking genetic
[[Page 31156]]
information as part of a voluntary health or genetic service, including
the rules on authorization and inducements, are met. In other words,
this example does not create an exception to the general rule that
inducements in return for genetic information are only permitted in one
specific circumstance--when an employee's spouse is asked to provide
information about his or her manifestation of disease, disorder, or
pathological condition as part of a HRA. We have revised the regulatory
language so that it emphasizes the requirements of Sec. 1635.8(b)(2),
including the rules on authorization and inducements.
Removal of Term ``Financial'' From Definition of ``Inducement''
Industry groups, employer associations, and several United States
Senators urged the Commission to alter this proposal so that the final
rule applies only to financial incentives. These groups argued that an
expansion of the definition of inducement would be inconsistent with
the Affordable Care Act and Congressional intent and would increase
administrative burden by requiring employers to calculate the value of
in-kind inducements, such as gift cards, raffle tickets, and key
chains. Many argued that applying the inducement rule to in-kind
inducements would cause employers to eliminate them altogether.
The final rule reaffirms the Commission's proposal to remove the
term ``financial'' as a modifier of the type of inducements discussed
in the regulations and make clear that the term ``inducements''
includes both financial and in-kind inducements, such as time-off
awards, prizes, or other items of value, in the form of either rewards
or penalties. Contrary to several comments received, this clarification
is consistent with the tri-Department wellness program provisions,
which generally define a reward as ``a discount or rebate of a premium
or contribution, a waiver of all or part of a cost-sharing mechanism,
an additional benefit, or any financial or other incentive.'' \49\
Thus, because the incentive limits in the Affordable Care Act apply to
in-kind incentives when they are offered within health-contingent
programs, Congress and the tri-Departments clearly considered that
these amounts would have to be calculated. Employers have flexibility
to determine the value of in-kind incentives, as long as the method is
reasonable.
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\49\ See 26 CFR 54.9802-1(f)(1)(i); 29 CFR 2590.702(f)(1)(i); 45
CFR 146.121(f)(1)(i); see also DOL--Employee Benefits Security
Administration, FAQs on Affordable Care Act Implementation (Part
XXIX) and Mental Health Parity Implementation, Question 11 (2015),
http://www.dol.gov/ebsa/pdf/faq-aca29.pdf.
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Technical Amendments
We received no comments concerning the proposed technical
amendments to the rule and they are therefore adopted without change.
Regulatory Procedures
Executive Order 12866
Pursuant to Executive Order 12866, the EEOC has coordinated this
final rule with the Office of Management and Budget. Under section
3(f)(1) of Executive Order 12866, the EEOC has determined that the
regulation will not have an annual effect on the economy of $100
million or more, or adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or state, local or tribal
governments or communities.\50\
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\50\ See General Comments: Burden for our response to the
commenter who expressed disagreement with our burden calculations.
---------------------------------------------------------------------------
Although a detailed cost-benefit assessment of the regulation is
not required, the Commission notes that the rule will aid compliance
with Title II of GINA by employers. Currently, employers face
uncertainty as to whether providing an employee with an inducement if
his or her spouse provides information about the spouse's manifestation
of disease or disorder on a HRA will subject them to liability under
Title II of GINA. This rule will clarify that offering limited
inducements in these circumstances is permitted by Title II of GINA if
the requirements of section 202(b)(2)(A) of GINA otherwise have been
met. We believe that a potential benefit of this rule is that it will
provide employers that adopt wellness programs that include spousal
inducements with clarity about their obligations under GINA.
The Commission does not believe the costs to employers associated
with the rule are significant. Under HIPAA, as amended by the
Affordable Care Act, inducements of up to 30 percent of the total cost
of coverage in which an employee is enrolled are permitted where the
employee and the employee's dependents are given the opportunity to
fully participate in a health-contingent wellness program. This final
rule simply clarifies that a similar inducement is permissible under
Title II of GINA where an employer offers inducements for an employee's
spouse enrolled in the group health plan to provide information about
his or her manifestation of disease or disorder. Where participation in
the employer-sponsored wellness program does not depend on enrollment
in a particular group health plan, employers will be able to calculate
the amount of the permissible inducement by reference to easily
verifiable sources, such as the cost of the group health plans they
provide or by reference to the second lowest cost Silver Plan available
on the Exchange in the location that the Employer identifies as its
principal place of business.
The Commission further believes that employers will face initial
start-up costs to train human resources staff and others on the revised
rule. The EEOC conducts extensive outreach and technical assistance
programs, many of them at no cost to employers, to assist in the
training of relevant personnel on EEO-related issues. For example, in
FY 2014, the agency's outreach programs reached more than 236,000
persons through participation in more than 3,500 no-cost educational,
training and outreach events. Now that the rule has become final, we
will include information about the revisions to the GINA regulations in
our outreach programs in general and continue to offer GINA-specific
outreach programs which will, of course, include information about the
revisions. As is our practice when issuing new regulations and policy
guidances, we have posted two technical assistance documents on our Web
site explaining the revisions to the GINA regulations.\51\
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\51\ See Qs and As: The Equal Employment Opportunity
Commission's Final Rule on the Genetic Information Nondiscrimination
Act and Employer Wellness Programs, EEOC, https://www.eeoc.gov/laws/types/genetic.cfm (last visited April 14, 2016); Small Business Fact
Sheet: Final Rule on Title II of the Genetic Information
Nondiscrimination Act and Employer Wellness Programs, EEOC, https://www.eeoc.gov/laws/types/genetic.cfm (last visited April 14, 2016).
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We estimate that there are approximately 782,000 employers with 15
or more employees subject to Title II of GINA \52\ and, of that number,
one half to two thirds (391,000 to 521,333) offer some type of
employer-sponsored wellness program.\53\ In the proposed rule, we
assumed that nearly half of employer-sponsored wellness programs
[[Page 31157]]
are open for participation by the spouses or dependents of workers, and
used the highest estimates, to conclude that approximately 260,667
employers will be covered by this requirement.\54\ Because the final
rule now applies to a broader set of wellness programs offered by
employers, we will increase these estimates and assume that 347,556
employers (two thirds of those who offer some type of wellness program)
offer spouses an opportunity to participate in, at the very least, an
employer-sponsored wellness program that is outside or not part of a
group health plan. We further estimate that the typical human resource
professional will need to dedicate, at most, 60 minutes to gain a
satisfactory understanding of the revised regulations and that the
median hourly pay rate of a human resource professional is
approximately $49.41.\55\ Assuming that an employer will train up to
three human resource professionals/managers on the requirements of this
rule, we estimate that initial training costs will be approximately
$51,518,230.\56\ The Commission sought comments on these cost estimates
and responded to the one comment received above. (See the discussion in
General Comments: Burden.)
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\52\ See Firm Size Data, Small Business Administration, http://www.sba.gov/advocacy/849/12162 (last visited March 28, 2016).
\53\ See RAND Final Report, supra note 36, xiv, http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf; see also Employer Health Benefits Survey, 6 (2014),
http://files.kff.org/attachment/2014-employer-health-benefits-survey-full-report [hereinafter the Kaiser Survey]. According to the
RAND Final Report, ``approximately half of U.S. employers offer
wellness promotion initiatives.'' By contrast, the Kaiser Survey
found that ``[s]eventy-four percent of employers offering health
benefits'' offer at least one wellness program.
\54\ Although the Kaiser Survey reports that 51 percent of large
employers versus 32 percent of small employers ask employees to
complete a HRA, see Kaiser Survey, supra note 50, we are not aware
of any data indicating what percentage of those employers provide
spouses with the opportunity to participate in the HRA. We therefore
have substituted a more general statistic to allow an estimate of
the number of employers who will be covered by the requirements of
this proposed rule. See Karen Pollitz & Matthew Roe, Kaiser Family
Foundation, Workplace Wellness Programs Characteristics and
Requirements 5 (2016), http://kff.org/private-insurance/issue-brief/workplace-wellness-programs-characteristics-and-requirements/
(noting that nearly half (48 percent) of employer wellness programs
are open for participation by the spouses or dependents of workers,
as well as workers).
\55\ See Occupational Employment and Wages, Bureau of Labor
Statistics, http://www.bls.gov/oes/current/oes113121.htm (last
visited March 28, 2016).
\56\ A study published in 2009 by the Society for Human Resource
Management (SHRM) found that the median number of full-time
equivalents for a HR department was three. See SHRM, Human Capital
Benchmarking Study 2009 Executive Summary, 6 (2009), https://www.shrm.org/Research/SurveyFindings/Articles/Documents/090620_Human_Cap_Benchmark_FULL_FNL.pdf. Because we are not aware of
any more specific data on the average number of human resources
professionals per covered employer, we have based our estimates on
this figure.
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Finally, GINA's plain language (at 42 U.S.C. 2000ff-(1)(b)(2)) and
the EEOC's regulations (at 29 CFR 1635.8(b)(2) and (c)(2)) make clear
that an employer must obtain authorization for the collection of
genetic information as part of providing health or genetic services to
employees and their family members on a voluntary basis. Consequently,
this rule imposes no new obligations with respect to authorization for
the collection of genetic information.
Paperwork Reduction Act
This rule contains no new information collection requirements
subject to review by the Office of Management and Budget under the
Paperwork Reduction Act (44 U.S.C. chapter 35).
Regulatory Flexibility Act
Title II of GINA applies to all employers with 15 or more
employees, approximately 764,233 of which are small firms (entities
with 15-500 employees) according to data provided by the Small Business
Administration Office of Advocacy.\57\
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\57\ See Firm Size Data, Small Business Administration, http://www.sba.gov/advocacy/849/12162 (last visited March 28, 2016).
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The Commission certifies under 5 U.S.C. 605(b) that this final rule
will not have a significant economic impact on a substantial number of
small entities because it imposes no reporting burdens and only minimal
costs on such firms. The rule simply clarifies that employers that
offer wellness programs are free to adopt a certain type of inducement
without violating GINA. It also corrects an internal citation and
provides citations to the Affordable Care Act. It does not require any
action on the part of covered entities, except to the extent that those
entities created documentation or forms which cite to GINA for the
proposition that the entity is unable to offer inducements to employees
in return for a spouse's completion of HRAs that request information
about the spouse's manifestation of disease or disorder. We do not have
data on the number or size of businesses that may need to alter
documents relating to their employer-sponsored wellness programs.
However, our experience with enforcing the ADA, which required all
employers with 15 or more employees to remove medical inquiries from
application forms, suggests that revising questionnaires to eliminate
or alter an instruction would not impose significant costs.
To the extent that employers will expend resources to train human
resources staff and others on the revised rule, we reiterate that the
EEOC conducts extensive outreach and technical assistance programs,
many of them at no cost to employers, to assist in the training of
relevant personnel on EEO-related issues. For example, in fiscal year
2014, the agency's outreach programs reached more than 236,000 persons
through participation in more than 3,500 no-cost educational, training
and outreach events. We will put information about the revisions to the
GINA regulations in our outreach programs in general and continue to
offer GINA-specific outreach programs which will, of course, include
information about the revisions now that the rule is final. We will
also post technical assistance documents on our Web site explaining the
revisions to the GINA regulations, as we do with all of our new
regulations and policy documents.
We estimate that the typical human resources professional will need
to dedicate, at most, 60 minutes to gain a satisfactory understanding
of the revised regulations. We further estimate that the median hourly
pay rate of a human resource professional is approximately $49.41.\58\
Assuming that small entities have between one and five human resource
professionals/managers, we estimate that the cost per entity of
providing appropriate training will be between approximately $49.41 and
$247.05. The EEOC does not believe that this cost will be significant
for the impacted small entities.
---------------------------------------------------------------------------
\58\ See Occupational Employment and Wages, supra note 53.
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Unfunded Mandates Reform Act of 1995
This final rule will not result in the expenditure by state, local,
or tribal governments, in the aggregate, or by the private sector, of
$100 million or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
List of Subjects in 29 CFR Part 1635
Administrative practice and procedure, Equal employment
opportunity.
For the reasons set forth in the preamble, the EEOC amends chapter
XIV of title 29 of the Code of Federal Regulations as follows:
PART 1635--[AMENDED]
0
1. The authority citation for part 1635 is revised to read as follows:
Authority: 29 U.S.C. 2000ff.
0
2. In Sec. 1635.8(b):
0
a. Redesignate paragraphs (b)(2)(i)(A) through (D) as paragraphs
(b)(2)(i)(B) through (E);
0
b. Add new paragraph (b)(2)(i)(A);
[[Page 31158]]
0
c. Revise paragraph (b)(2)(ii) introductory text;
0
d. Redesignate paragraphs (b)(2)(iii) and (iv) as paragraphs (b)(2)(vi)
and (vii);
0
e. Add new paragraphs (b)(2)(iii) through (v);
0
f. Revise newly redesignated paragraph (b)(2)(vii); and
0
g. Revise paragraph (c)(2).
The revisions and additions read as follows:
Sec. 1635.8 Acquisition of genetic information.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(A) The health or genetic services, including any acquisition of
genetic information that is part of those services, are reasonably
designed to promote health or prevent disease. A program satisfies this
standard if it has a reasonable chance of improving the health of, or
preventing disease in, participating individuals, and it is not overly
burdensome, is not a subterfuge for violating Title II of GINA or other
laws prohibiting employment discrimination, and is not highly suspect
in the method chosen to promote health or prevent disease. A program is
not reasonably designed to promote health or prevent disease if it
imposes a penalty or disadvantage on an individual because a spouse's
manifestation of disease or disorder prevents or inhibits the spouse
from participating or from achieving a certain health outcome. For
example, an employer may not deny an employee an inducement for
participation of either the employee or the spouse in an employer-
sponsored wellness program because the employee's spouse has blood
pressure, a cholesterol level, or a blood glucose level that the
employer considers too high. In addition, a program consisting of a
measurement, test, screening, or collection of health-related
information without providing participants with results, follow-up
information, or advice designed to improve the participant's health is
not reasonably designed to promote health or prevent disease, unless
the collected information actually is used to design a program that
addresses at least a subset of conditions identified. Whether health or
genetic services are reasonably designed to promote health or prevent
disease is evaluated in light of all the relevant facts and
circumstances.
* * * * *
(ii) Consistent with, and in addition to, the requirements of
paragraph (b)(2)(i) of this section, a covered entity may not offer an
inducement (financial or in-kind), whether in the form of a reward or
penalty, for individuals to provide genetic information, except as
described in paragraphs (b)(2)(iii) and (iv) of this section, but may
offer inducements for completion of health risk assessments that
include questions about family medical history or other genetic
information, provided the covered entity makes clear, in language
reasonably likely to be understood by those completing the health risk
assessment, that the inducement will be made available whether or not
the participant answers questions regarding genetic information.
* * * * *
(iii) Consistent with, and in addition to, the requirements of
paragraphs (b)(2)(i) and (ii) of this section, a covered entity may
offer an inducement to an employee whose spouse provides information
about the spouse's manifestation of disease or disorder as part of a
health risk assessment. No inducement may be offered, however, in
return for the spouse's providing his or her own genetic information,
including results of his or her genetic tests, or for information about
the manifestation of disease or disorder in an employee's children or
for genetic information about an employee's children, including adult
children. The health risk assessment, which may include a medical
questionnaire, a medical examination (e.g., to detect high blood
pressure or high cholesterol), or both, must otherwise comply with
paragraph (b)(2)(i) of this section in the same manner as if completed
by the employee, including the requirement that the spouse provide
prior, knowing, voluntary, and written authorization, and the
requirement that the authorization form describe the confidentiality
protections and restrictions on the disclosure of genetic information.
The health risk assessment must also be administered in connection with
the spouse's receipt of health or genetic services offered by the
employer, including such services offered as part of an employer-
sponsored wellness program. When an employee and spouse are given the
opportunity to participate in an employer-sponsored wellness program,
the inducement to each may not exceed:
(A) Thirty percent of the total cost of self-only coverage under
the group health plan in which the employee is enrolled, if enrollment
in the plan is a condition for participation in the employer-sponsored
wellness program. For example, if an employee is enrolled in health
insurance through the employer at a total cost (taking into account
both employer and employee contributions toward the cost of coverage)
of $14,000 for family coverage, that plan has a self-only option for
$6,000, and the employer provides the option of participating in a
wellness program to the employee and spouse because they are enrolled
in the plan, the employer may not offer more than $1,800 to the
employee and $1,800 to the spouse.
(B) Thirty percent of the total cost of self-only coverage under
the group health plan offered by the employer where the employer offers
a single group health plan, but participation in a wellness program
does not depend on the employee's or spouse's enrollment in that plan.
For example, if the employer offers one group health plan and self-only
coverage under that plan costs $7,000, and the employer provides the
option of participation in a wellness program to the employee and the
spouse, the employer may not offer more than $2,100 to the employee and
$2,100 to the spouse.
(C) Thirty percent of the total cost of the lowest cost self-only
coverage under a major medical group health plan offered by the
employer, if the employer offers more than one group health plan but
enrollment in a particular plan is not a condition for participation in
the wellness program. For example, if the employer has more than one
major medical group health plan under which self-only coverage ranges
in cost from $5,000 to $8,000, and the employer provides the option of
participation in a wellness program to the employee and the spouse, the
employer may not offer more than $1,500 to the employee and $1,500 to
the spouse.
(D) Thirty percent of the cost of self-only coverage available to
an individual who is 40 years old and a non-smoker under the second
lowest cost Silver Plan available through the Exchange in the location
that the employer identifies as its principal place of business is
located, where the employer has no group health plan. For example, if
the cost of insuring a 40-year-old non-smoker is $4,000 annually, the
maximum inducement the employer could offer the employee and the spouse
would be no more than $1,200 each.
(iv) A covered entity may not, however, condition participation in
an employer-sponsored wellness program or provide any inducement to an
employee, or the spouse or other covered dependent of the employee, in
exchange for an agreement permitting the sale, exchange, sharing,
transfer, or other disclosure of genetic information, including
information about the
[[Page 31159]]
manifestation of disease or disorder of an employee's family member
(except to the extent permitted by paragraph (b)(2)(i)(D)) of this
section, or otherwise waiving the protections of Sec. 1635.9.
(v) A covered entity may not deny access to health insurance or any
package of health insurance benefits to an employee, or the spouse or
other covered dependent of the employee, or retaliate against an
employee, due to a spouse's refusal to provide information about his or
her manifestation of disease or disorder to an employer-sponsored
wellness program.
* * * * *
(vii) Nothing contained in paragraphs (b)(2)(ii) through (v) of
this section limits the rights or protections of an individual under
the Americans with Disabilities Act (ADA), as amended, or other
applicable civil rights laws, or under the Health Insurance Portability
and Accountability Act (HIPAA), as amended by GINA. For example, if an
employer offers an inducement for participation in disease management
programs or other programs that promote healthy lifestyles and/or
require individuals to meet particular health goals, the employer must
make reasonable accommodations to the extent required by the ADA; that
is, the employer must make modifications or adjustments that enable a
covered entity's employee with a disability to enjoy equal benefits and
privileges of employment as are enjoyed by its other similarly situated
employees without disabilities unless such covered entity can
demonstrate that the accommodation would impose an undue hardship on
the operation of its business. See 29 CFR 1630.2(o)(1)(iii) and 29 CFR
1630.9(a). In addition, if the employer's wellness program provides
(directly, through reimbursement, or otherwise) medical care (including
genetic counseling), the program may constitute a group health plan and
must comply with the special requirements for employer-sponsored
wellness programs that condition rewards on an individual satisfying a
standard related to a health factor, including the requirement to
provide an individual with a reasonable alternative (or waiver of the
otherwise applicable standard) under HIPAA, when it is unreasonably
difficult due to a medical condition to satisfy or medically
inadvisable to attempt to satisfy the otherwise applicable standard.
See section 9802 of the Internal Revenue Code (26 U.S.C. 9802, 26 CFR
54.9802-1 and 54.9802-3T), section 702 of the Employee Retirement
Income Security Act of 1974 (ERISA) (29 U.S.C. 1182, 29 CFR 2590.702
and 2590.702-1), and section 2705 of the Public Health Service (PHS)
Act (45 CFR 146.121, 146.122, and 147.110), as amended by section 1201
of the Affordable Care Act.
* * * * *
(c) * * *
(2) A covered entity does not violate this section when it
requests, requires, or purchases genetic information or information
about the manifestation of a disease, disorder, or pathological
condition of an individual's family member who is receiving health or
genetic services on a voluntary basis, as long as the requirements of
paragraph (b)(2) of this section, including those concerning
authorization and inducements, are met. For example, an employer does
not unlawfully acquire genetic information about an employee when it
asks the employee's family member who is receiving health services from
the employer if her diabetes is under control. Nor does an employer
unlawfully acquire genetic information about an employee when it seeks
information--through a medical questionnaire, a medical examination, or
both--about the manifestation of disease, disorder, or pathological
condition of the employee's family member who is completing a health
risk assessment on a voluntary basis in connection with the family
member's receipt of health or genetic services (including health or
genetic services provided as part of an employer-sponsored wellness
program) offered by the employer in compliance with paragraph (b)(2) of
this section.
* * * * *
0
3. In Sec. 1635.11, revise paragraphs (b)(1)(iii) and (iv) to read as
follows:
Sec. 1635.11 Construction.
* * * * *
(b) * * *
(1) * * *
(iii) Section 702(a)(1)(F) of ERISA (29 U.S.C. 1182(a)(1)(F)),
section 2705(a)(6) of the PHS Act, as amended by section 1201 of the
Affordable Care Act and section 9802(a)(1)(F) of the Internal Revenue
Code (26 U.S.C. 9802(a)(1)(F)), which prohibit a group health plan or a
health insurance issuer in the group or individual market from
discriminating against individuals in eligibility and continued
eligibility for benefits based on genetic information; or
(iv) Section 702(b)(1) of ERISA (29 U.S.C. 1182(b)(1)), section
2705(b)(1) of the PHS Act, as amended by section 1201 of the Affordable
Care Act and section 9802(b)(1) of the Internal Revenue Code (26 U.S.C.
9802(b)(1)), as such sections apply with respect to genetic information
as a health status-related factor, which prohibit a group health plan
or a health insurance issuer in the group or individual market from
discriminating against individuals in premium or contribution rates
under the plan or coverage based on genetic information.
* * * * *
Dated: May 11, 2016.
For the Commission:
Jenny R. Yang,
Chair.
[FR Doc. 2016-11557 Filed 5-16-16; 8:45 am]
BILLING CODE 6570-01-P