Genetic Information Nondiscrimination Act, 31143-31159 [2016-11557]
Download as PDF
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
transgender status, and sexual orientation),
color, religion, national origin, or age.
Additionally, if a wellness program
requirement (such as a particular blood
pressure or glucose level or body mass index)
disproportionately affects individuals on the
basis of some protected characteristic, an
employer may be able to avoid a disparate
impact claim by offering and providing a
reasonable alternative standard.
Section 1630.14(d)(6): Inapplicability of the
ADA’s Safe Harbor Provision
Finally, section 1630.14(d)(6) states that
the ‘‘safe harbor’’ provision, set forth in
section 501(c) of the ADA, 42 U.S.C.
12201(c), that allows insurers and benefit
plans to classify, underwrite, and administer
risks, does not apply to wellness programs,
even if such programs are part of a covered
entity’s health plan. The safe harbor permits
insurers and employers (as sponsors of health
or other insurance benefits) to treat
individuals differently based on disability,
but only where justified according to
accepted principles of risk classification
(some of which became unlawful subsequent
to passage of the ADA). See Senate Report at
85–86; House Education and Labor Report at
137–38. It does not apply simply because a
covered entity asserts that it used
information collected as part of a wellness
program to estimate, or to try to reduce, its
risks or health care costs.
Dated: May 11, 2016.
For the Commission:
Jenny R. Yang,
Chair.
[FR Doc. 2016–11558 Filed 5–16–16; 8:45 am]
BILLING CODE 6570–01–P
EQUAL EMPLOYMENT OPPORTUNITY
COMMISSION
29 CFR Part 1635
RIN 3046–AB02
Genetic Information Nondiscrimination
Act
Equal Employment
Opportunity Commission.
ACTION: Final rule.
AGENCY:
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
mstockstill on DSK3G9T082PROD with RULES2
SUMMARY:
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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. Employersponsored 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
1 42
U.S.C. 2000ff–2000ff–11.
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.
2 42
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
31143
Labor (DOL), Department of the
Treasury (Treasury), and Department of
Health and Human Services (HHS)
(referred to collectively as the triDepartments).4 This final rule relates
specifically to the requirements of Title
II of GINA as they apply to employersponsored wellness programs, though
other applicable laws are discussed in
some detail.
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
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
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.
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).
E:\FR\FM\17MYR2.SGM
17MYR2
31144
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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
There are only six limited
circumstances in which an employer 13
may request, require, or purchase
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.
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.
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 employersponsored 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
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
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
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 employersponsored 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
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).
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.’’
E:\FR\FM\17MYR2.SGM
17MYR2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
information about manifestation of
diseases or disorders in, or genetic
information about, an employee’s
children.
Background on the Notice of Proposed
Rulemaking on GINA and EmployerSponsored Wellness Programs
mstockstill on DSK3G9T082PROD with RULES2
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.
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).
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).
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
• 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 employersponsored 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 employersponsored 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.
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
31145
• 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.
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
23 One of these comments was withdrawn when
the commenter submitted a ‘‘corrected’’ version of
the comment.
E:\FR\FM\17MYR2.SGM
17MYR2
31146
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
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 employersponsored 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.
mstockstill on DSK3G9T082PROD with RULES2
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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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
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 triDepartments’ 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 employersponsored 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),
https://www.dol.gov/ebsa/pdf/faq-aca25.pdf and
https://www.cms.gov/CCIIO/Resources/Fact-Sheetsand-FAQs/Downloads/Tri-agency-Wellness-FAQS4-16-15pdf-AdobeAcrobat-Pro.pdf.
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
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.
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
25 See
E:\FR\FM\17MYR2.SGM
80 FR at 66857, supra note 20.
17MYR2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 § 1635.8(b)(2)(v).
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 § 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
§ 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
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.
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 employersponsored 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
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
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.
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
31147
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
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
29 See
E:\FR\FM\17MYR2.SGM
29 CFR 1635.8(b)(2)(A)(iii).
17MYR2
31148
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 employersponsored 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 employersponsored 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 reidentification 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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
30 See
42 U.S.C. 2000ff–5; 29 CFR 1635.9.
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).
31 See
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
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.
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 § 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
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.
E:\FR\FM\17MYR2.SGM
17MYR2
mstockstill on DSK3G9T082PROD with RULES2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
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.
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.
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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
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 triDepartment wellness regulations
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).
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
31149
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.
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
38 See, e.g., RAND Health, Workplace Wellness
Programs Study Final Report, 101 (2013), https://
www.rand.org/content/dam/rand/pubs/
research_reports/RR200/RR254/RAND_RR254.pdf
[hereinafter RAND Final Report].
E:\FR\FM\17MYR2.SGM
17MYR2
31150
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 employersponsored 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 employerprovided wellness programs). Others
argued that since it is unclear whether
certain kinds of genetic information can
ever be stored in a way that prevents reidentification, 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
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
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
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
39 See
42 U.S.C. 2000ff–5(b); 29 CFR 1635.9.
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.
40 See
E:\FR\FM\17MYR2.SGM
17MYR2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 employersponsored 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 employersponsored 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
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
31151
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 employersponsored 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 employersponsored 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.
E:\FR\FM\17MYR2.SGM
17MYR2
31152
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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,
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
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.
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 employersponsored 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
42 See 29 CFR 1630.14(d)(1); published elsewhere
in this issue of the Federal Register.
E:\FR\FM\17MYR2.SGM
17MYR2
mstockstill on DSK3G9T082PROD with RULES2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
completion of HRAs when the
requirements of § 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 § 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 § 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 EmployerSponsored 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
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,
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
Comments: Prohibition on Inducements
for Information From Children of
Employees.)
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 employerrequiring 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, employersponsored 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.
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
31153
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 triDepartments’ 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
E:\FR\FM\17MYR2.SGM
17MYR2
mstockstill on DSK3G9T082PROD with RULES2
31154
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
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 employersponsored 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 selfonly 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 employersponsored 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
44 There
are four ‘‘metal’’ categories of health
plans in the Exchanges established under the
Affordable Care Act: Bronze, Silver, Gold, and
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 40year-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.
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 selfonly 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 selfonly 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.
Platinum. See How To Pick a Health Insurance
Plan: The ‘‘Metal Categories’’, Healthcare.gov,
https://www.healthcare.gov/choose-a-plan/planscategories (last visited March 29, 2016).
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
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.
Revisions will be made to
§ 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
45 See
26 U.S.C. 36B(b)(2).
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.)
46 See,
E:\FR\FM\17MYR2.SGM
17MYR2
mstockstill on DSK3G9T082PROD with RULES2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
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 § 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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.
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
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).
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
31155
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 § 1635.9. As
explained above, however, the
Commission does not believe that any
further changes are needed because the
confidentiality protections of § 1635.9,
as well as the specific disclosure rules
that apply to health and genetic services
set forth at § 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
E:\FR\FM\17MYR2.SGM
17MYR2
31156
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 § 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 timeoff 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 in49 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), https://www.dol.gov/ebsa/pdf/
faq-aca29.pdf.
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
kind incentives, as long as the method
is reasonable.
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
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 employer50 See General Comments: Burden for our
response to the commenter who expressed
disagreement with our burden calculations.
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
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
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
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).
52 See Firm Size Data, Small Business
Administration, https://www.sba.gov/advocacy/849/
12162 (last visited March 28, 2016).
53 See RAND Final Report, supra note 36, xiv,
https://www.rand.org/content/dam/rand/pubs/
research_reports/RR200/RR254/RAND_RR254.pdf;
see also Employer Health Benefits Survey, 6 (2014),
https://files.kff.org/attachment/2014-employerhealth-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.
E:\FR\FM\17MYR2.SGM
17MYR2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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.)
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
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), https://
kff.org/private-insurance/issue-brief/workplacewellness-programs-characteristics-andrequirements/ (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, https://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.
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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
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 employersponsored 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
57 See Firm Size Data, Small Business
Administration, https://www.sba.gov/advocacy/849/
12162 (last visited March 28, 2016).
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
31157
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.
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]
1. The authority citation for part 1635
is revised to read as follows:
■
Authority: 29 U.S.C. 2000ff.
2. In § 1635.8(b):
a. Redesignate paragraphs (b)(2)(i)(A)
through (D) as paragraphs (b)(2)(i)(B)
through (E);
■ b. Add new paragraph (b)(2)(i)(A);
■
■
58 See Occupational Employment and Wages,
supra note 53.
E:\FR\FM\17MYR2.SGM
17MYR2
31158
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
c. Revise paragraph (b)(2)(ii)
introductory text;
■ d. Redesignate paragraphs (b)(2)(iii)
and (iv) as paragraphs (b)(2)(vi) and
(vii);
■ e. Add new paragraphs (b)(2)(iii)
through (v);
■ f. Revise newly redesignated
paragraph (b)(2)(vii); and
■ g. Revise paragraph (c)(2).
The revisions and additions read as
follows:
■
§ 1635.8 Acquisition of genetic
information.
mstockstill on DSK3G9T082PROD with RULES2
*
*
*
*
*
(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 healthrelated 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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 employersponsored 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
PO 00000
Frm 00034
Fmt 4701
Sfmt 4700
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 selfonly 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
E:\FR\FM\17MYR2.SGM
17MYR2
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Rules and Regulations
mstockstill on DSK3G9T082PROD with RULES2
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 § 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
VerDate Sep<11>2014
18:56 May 16, 2016
Jkt 238001
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
PO 00000
Frm 00035
Fmt 4701
Sfmt 9990
31159
connection with the family member’s
receipt of health or genetic services
(including health or genetic services
provided as part of an employersponsored wellness program) offered by
the employer in compliance with
paragraph (b)(2) of this section.
*
*
*
*
*
■ 3. In § 1635.11, revise paragraphs
(b)(1)(iii) and (iv) to read as follows:
§ 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 statusrelated 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
E:\FR\FM\17MYR2.SGM
17MYR2
Agencies
[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]
-----------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
29 CFR Part 1635
RIN 3046-AB02
Genetic Information Nondiscrimination Act
AGENCY: Equal Employment Opportunity Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
[[Page 31145]]
information about manifestation of diseases or disorders in, or genetic
information about, an employee's children.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\23\ One of these comments was withdrawn when the commenter
submitted a ``corrected'' version of the comment.
---------------------------------------------------------------------------
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
[[Page 31146]]
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.
---------------------------------------------------------------------------
\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), https://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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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), https://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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\42\ See 29 CFR 1630.14(d)(1); published elsewhere in this issue
of the Federal Register.
---------------------------------------------------------------------------
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.)
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.)
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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),
https://www.dol.gov/ebsa/pdf/faq-aca29.pdf.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.)
---------------------------------------------------------------------------
\52\ See Firm Size Data, Small Business Administration, https://www.sba.gov/advocacy/849/12162 (last visited March 28, 2016).
\53\ See RAND Final Report, supra note 36, xiv, https://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf; see also Employer Health Benefits Survey, 6 (2014),
https://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), https://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, https://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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\57\ See Firm Size Data, Small Business Administration, https://www.sba.gov/advocacy/849/12162 (last visited March 28, 2016).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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