EMPLOYMENT LAW PROVISIONS OF THE GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (GINA) Mark A....
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EMPLOYMENT LAW PROVISIONS OF THE GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (GINA) Mark A. Rothstein, J.D. Herbert F. Boehl Chair of Law and Medicine
EMPLOYMENT LAW PROVISIONS OF THE GENETIC INFORMATION
NONDISCRIMINATION ACT OF 2008 (GINA) Mark A. Rothstein, J.D.
Herbert F. Boehl Chair of Law and Medicine Director, Institute for
Bioethics, Health Policy and Law University of Louisville School of
Medicine 2009
Slide 2
LIFE BEFORE GINA A. State Laws First state laws prohibiting
genetic discrimination in health insurance and employment were
enacted by Florida, Louisiana, and North Carolina in the early
1970s. They applied only to discrimination based on sickle cell
trait. The number of states and conditions expanded through the
1970s and 1980s.
Slide 3
The launch of the Human Genome Project in 1990 provided the
impetus for most states to enact genetic privacy and
nondiscrimination laws.
Slide 4
WHAT IS DISCRIMINATION? It is more than just drawing
distinctions. In common usage and in legal terms it refers to
drawing distinctions based on invidious, unfair, or socially
unacceptable criteria.
Slide 5
CONCERNS ABOUT GENETIC DISCRIMINATION 1.Predictions are
inaccurate 2.Predictions are accurate
Slide 6
Categories of discrimination LEGAL RATIONAL Choosing an
employee based on relative skill or other job-related criteria
Choosing an employee based on medical assessment of ability to
perform the job IRRATIONAL Choosing an employee based on Zodiac
sign Choosing an employee based on a coin toss ILLEGAL Excluding a
person with cancer from consideration for employment based on
concerns about health care costs Excluding a pregnant woman from
consideration for employment because she may soon go on maternity
leave Excluding a person from consideration for employment based on
religion (in a secular enterprise) Excluding a person from
consideration for employment based on national origin
Slide 7
STATE GENETIC NONDISCRIMINATION LAWS 34 states and the District
of Columbia prohibit genetic discrimination in hiring, firing,
and/or terms, conditions, or privileges of employment. 25 states
prohibit employers from requiring genetic information or a genetic
test. 18 states prohibit employers from requesting genetic
information or a genetic test.
Slide 8
16 states prohibit employers from performing a genetic test. 14
states provide specific penalties for genetic discrimination in
employment. 11 states prohibit employers from obtaining information
about a genetic test result.
Slide 9
Federal Law Executive Order 13145 (2000) Prohibits
discrimination in federal government employment based on genetic
information Prohibits federal employers from acquiring genetic
information Prohibits federal employers from disclosing genetic
information (with some exceptions) Federal employers must protect
the confidentiality of the genetic information of employees
Slide 10
A. Need for GINA HIPAA prevents genetic discrimination in
employer-sponsored group health plans (both commercial and
self-insured). Laws in most states prohibit genetic discrimination
in individual health insurance policies and employment. Was there a
need for GINA?
Slide 11
B. Reasons for Enacting GINA 1.GINA was originally introduced
in Congress (1995) before HIPAA was enacted (1996) and before most
states had enacted laws prohibiting genetic discrimination in
health insurance. 2.GINA was intended to improve upon the confusing
and inadequate patchwork of state and federal laws.
Slide 12
3.GINA was intended to add protection in states without genetic
nondiscrimination laws. 4.GINA was intended to allay the concerns
of individuals who (despite a lack of documented instances of
discrimination and existing protections) were afraid to undergo
genetic testing in research and clinical settings because of
possible discrimination.
Slide 13
GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 Public Law
110-233, 122 Stat. 881 42 U.S.C. 2000ff Title I. Genetic
Nondiscrimination in Health Insurance Title II.Prohibiting
Employment Discrimination on the Basis of Genetic Information Title
III.Miscellaneous Provisions.
Slide 14
Slide 15
GINA is intended to fully protect the public from
discrimination and allay their concerns about the potential for
discrimination, thereby allowing individuals to take advantage of
genetic testing, technologies, research, and new therapies. GINA
2(5).
Slide 16
A. Definition of Genetic Information The term genetic
information means, with respect to any individual, information
about i.such individuals genetic tests, ii.the genetic tests of
family members of such individual, and iii.the manifestation of a
disease or disorder in family members of such individual.
Slide 17
Such term includes... any request for, or receipt of, genetic
services, or participation in clinical research which includes
genetic services, by such individual or any family member of such
individual. GINA 101(d).
Slide 18
B. Definition of Genetic Test The term genetic test means an
analysis of human DNA, RNA, chromosomes, proteins, or metabolites,
that detects genotypes, mutations, or chromosomal changes.
Slide 19
It does not include an analysis that is directly related to a
manifested disease, disorder, or pathological condition that could
reasonably be detected by a health care professional with
appropriate training and expertise in the field of medicine
involved. GINA 101(d).
Slide 20
KEY PROVISIONS OF GINA (TITLE II) Coverage and Remedies Similar
to Title VII Applies to employers with 15+ employees, employment
agencies, labor organizations, and training programs EEOC to issue
regulations by May 21, 2009 Proposed regulations issued March 2,
2009 (74 Fed. Reg. 9056)
Slide 21
Remedies the same as Title VII No disparate impact claims State
laws not preempted
Slide 22
Prohibitions under Title II Employment Discrimination Based on
Genetic Information Hiring, firing, job assignments/training,
compensation, terms, conditions, and privileges of employment
Limiting, segregating, classifying in ways that adversely affect
employee status
Slide 23
Requesting, requiring, or purchasing genetic information about
employees (including applicants) Retaliating against employees who
exercise rights under GINA
Slide 24
Some Methods of Acquiring Genetic Information That Are Not
Unlawful Inadvertent requests/ requirements/ voluntary disclosures
Workplace health services (e.g., wellness programs) FMLA
certification
Slide 25
Some Permissible Disclosures of Genetic Information To employee
on written request In response to court order To public health
agencies when it concerns a contagious disease that presents an
imminent threat of death or serious illness
Slide 26
Permissible Genetic Monitoring To assess the effects of toxic
substances in the workplace under the following conditions:
1.written notice is provided to the employee; 2.the employee
provides voluntary, written authorization or the monitoring is
required by law;
Slide 27
3.the employee is informed of individual results; 4.the
monitoring is in compliance with applicable regulations; and 5.the
employer receives results only in aggregate form. Note: GINA makes
no provision for similar preplacement genetic tests of applicants
and employees.
Slide 28
GINAS LIMITATIONS 1.GINA does not apply to life insurance,
disability insurance, long-term care insurance, or other uses of
genetic information. Are the limited protections (health insurance
and employment) enough to allay the concerns of the public?
Slide 29
2.GINA does not apply to non-genetic predictive testing and
information (e.g., epigenetics).
Slide 30
Epigenetic changes are alterations in the chemical makeup of
DNA that do not involve modifying the DNA sequence. Epigenetic
changes influence whether genes are expressed. Q: Is GINA stuck in
todays (or yesterdays) science?
Slide 31
3.GINA adopts the approach known as genetic exceptionalism.
Will enacting genetic-specific federal legislation increase the
stigma associated with genetic conditions, genetic tests, and
genetic services? If so, GINA will have made matters worse.
Slide 32
4.GINAs employment provisions are unlikely to limit the
disclosure of genetic information to employees. GINA 202(b) makes
it an unlawful employment practice for an employer to request,
require, or purchase genetic information with respect to an
employee or a family member of the employee.
Slide 33
But, 102(d)(3) of the ADA permits employers, after a
conditional offer of employment, to require the individual to sign
an authorization for the disclosure of all of the individuals
health records, regardless of the job in question or the
individuals health status.
Slide 34
Each year, there are at least 10.2 million blanket
authorizations signed at the preplacement stage of the employment
process. Even if the custodians of the health records wanted to
release only non-genetic information, there is no practical way to
do so with either paper or electronic health records, and most
custodians are likely to continue the current practice of releasing
everything.
Slide 35
GINA does not address the issue of using "contextual access
criteria" (computer software) to limit the scope of disclosure of
health information.
Slide 36
5.GINAs employment provisions create a gap with the ADAs
protections.
Slide 37
Asymptomatic Biomarkers, mild symptoms "Manifestation of
disease" GINAYes?No ADANo Yes
Slide 38
Genetic Predisposition and the ADA In 1995, the EEOC issued a
non-binding interpretation of the ADA that individuals who are
subject to discrimination on the basis of genetic information
relating to illness, disease, or other disorders are being regarded
as having a disability.
Slide 39
Most observers believed that this interpretation did not
survive Sutton in 1999, but the ADA Amendments Act of 2008
overturned Sutton in major respects, including the effect of
mitigating measures. The issue is largely academic now because such
discrimination violates GINA.
Slide 40
EVALUATING GINA 1.GINA has symbolic value, and that may be
important (e.g., ADA)
Slide 41
2.GINA avoids the underlying societal problem. Genetic
discrimination in health insurance is not about genetics!
Slide 42
It is about health care finance and access to health care.
Slide 43
The key questions: Should individuals who are ill or more
likely to become ill (for any reason) be able to obtain individual
health insurance coverage without medical underwriting? Should
there be a universal right of access to health care coverage?
Slide 44
3.GINA does not resolve the broader issue of the relative
rights of employers vs. employees to control access to health
information, including predictive health information.
Slide 45
4.GINA does not address the issue of genetic privacy.
Electronic health records and networks create comprehensive,
longitudinal, interoperable health files for all individuals.
Slide 46
To what extent, if any, should individuals be able to isolate
or sequester sensitive information in their health records? When
will additional restrictions be placed on access to and use of
sensitive health information by third party requestors?
Slide 47
GOING FORWARD Does GINA represent a foot in the door to more
comprehensive and effective legislation OR...
Slide 48
... is GINA the one bite of the apple in enacting genetic
nondiscrimination law?
Slide 49
Will any attempt to amend GINA be met with legislative fatigue,
as policy makers think they have resolved genetic
discrimination?