Frequently Asked Questions 
Regarding the Genetic Information 
 
Nondiscrimination Act
U.S. Department of Labor
 
Employee Benefits Security Administration 
Q1:  What is the Genetic Information Nondiscrimination Act (GINA)? 
The subject of these Frequently Asked Questions is the requirements of Title I of GINA under the 
Employee Retirement Income Security Act (ERISA), prohibiting discrimination in group health plan 
coverage based on genetic information. 
GINA expands the genetic information nondiscrimination protections included in Title I of the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). Under GINA, group health plans cannot 
base premiums for a plan or a group of similarly situated individuals on genetic information. GINA 
generally prohibits plans from requesting or requiring an individual to undergo genetic tests, and 
prohibits a plan from collecting genetic information (including family medical history) prior to or in 
connection with enrollment, or for underwriting purposes. 
GINA applies generally to group health plans. Unlike the provisions under Title I of HIPAA, there is no 
exception for very small health plans with less than two participants who are current employees. 
Q2:  How does GINA expand the genetic information nondiscrimination protections in 
HIPAA? 
Before the Affordable Care Act, HIPAA prevented a plan or issuer from imposing a preexisting 
condition exclusion based solely on genetic information.  Under the Affordable Care Act, plans are 
prohibited from excluding coverage or benefits due to any preexisting condition.  HIPAA continues to 
prohibit discrimination in individual eligibility, benefits, or premiums based on any health factor 
(including genetic information). GINA provides additional underwriting protections, prohibits 
requesting or requiring genetic testing, and restricts the collection of genetic information. Specifically: 
 GINA provides that group health plans cannot adjust premiums or contribution amounts
for a plan, or any group of similarly situated individuals under the plan, based on genetic
information of one or more individuals in the group. (However, premiums may be
increased for the group based upon the manifestation of a disease or disorder of an
individual enrolled in the plan.)
 GINA generally prohibits plans from requesting or requiring an individual to undergo a
genetic test. However, a health care professional providing health care services to an
individual is permitted to request a genetic test. A plan or issuer may request the results of a
genetic test to determine payment of a claim for benefits, but only the minimum amount of
information necessary in order to determine payment. There is also a research exception that
permits a plan or issuer under certain conditions to request (but not require) that a
participant or beneficiary undergo a genetic test. 2 
 GINA prohibits a plan from collecting genetic information (including family medical history)
from an individual prior to or in connection with their enrollment in the plan, or at any time
for underwriting purposes. Under GINA, underwriting purposes includes rules for
determination of eligibility for benefits and the computation of premium and contribution
amounts. Thus, under GINA, plans are generally prohibited from offering rewards in return
for the provision of genetic information, including family medical history information
collected as part of a Health Risk Assessment (HRA). GINA includes an exception for
incidental collection of genetic information, provided the information is not used for
underwriting purposes. However, the regulations make clear that the incidental collection
exception is not available if it is reasonable for the plan or issuer to anticipate that health
information will be received in response to a collection, unless the collection explicitly states
that genetic information should not be provided.
Q3:  What is genetic information? 
Genetic information means information about an individuals genetic tests, the genetic tests of family 
members of the individual, the manifestation of a disease or disorder in family members of the 
individual or any request for or receipt of genetic services, or participation in clinical research that 
includes genetic services by the individual or a family member of the individual. The term genetic 
information includes, with respect to a pregnant woman (or a family member of a pregnant woman) 
genetic information about the fetus and with respect to an individual using assisted reproductive 
technology, genetic information about the embryo. 
Genetic information does not include information about the sex or age of any individual. 
Q4:  Genetic information includes information about an individuals genetic services and 
tests.  What do these include? 
Genetic services mean genetic tests, genetic counseling, or genetic education. Genetic test means an 
analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if the analysis detects genotypes, 
mutations, or chromosomal changes. A genetic test does not include an analysis of proteins or 
metabolites directly related to a manifested disease, disorder, or pathological condition. 
Therefore, some examples of genetic tests are tests to determine whether an individual has a BRCA1, 
BRCA2, or colorectal cancer genetic variant. In contrast, an HIV test, complete blood count, cholesterol 
test, liver function test, or test for the presence of alcohol or drugs is not a genetic test. 
Q5:  Genetic information includes an individuals genetic tests and information about the 
manifestation of a disease or disorder in an individuals family member. A genetic test 
does not include an analysis of proteins or metabolites that is directly related to a 
manifested disease, disorder, or pathological condition.  What is a manifested 
disease? 
A manifested disease is a disease, disorder, or pathological condition for which an individual has been 
or could reasonably be diagnosed by a health care professional (with appropriate training and expertise 
in the field of medicine involved). 
A disease is not manifested if a diagnosis is based principally on genetic information. For example, an 
individual whose genetic tests indicate a genetic variant associated with colorectal cancer and another  3 
that indicates an increased risk of developing cancer, but who has no signs or symptoms of disease and 
has not and could not reasonably be diagnosed with a disease does not have a manifested disease. 
While plans are prohibited from adjusting group premiums or contributions based on genetic 
information, plans can increase the premium or contribution based on the manifested disease or 
disorder of an individual enrolled in the plan. This is because information about an individuals 
manifested disease or disorder is not genetic information with respect to that individual. This is 
discussed further in Q7. 
Q6:  GINA prohibits a plan from collecting genetic information (including family medical 
history) prior to or in connection with enrollment, or at any time for underwriting 
purposes. What does collect include? 
Collect means to request, require, or purchase genetic information. 
Q7:  Can a group health plan adjust the premium that an employer or group of similarly 
situated individuals must pay under the plan based on genetic information of an 
individual or individuals covered under the group? 
No. GINA prohibits a group health plan from adjusting group premium or contribution amounts for a 
group of similarly situated individuals based on the genetic information of members of the group. This 
is a change from HIPAAs prior nondiscrimination requirements, which allowed plans to adjust 
premiums or contributions for  the group health plan or group of similarly situated individuals (but not 
for specific individuals within the group) based on genetic information, as well as other health factors. 
Therefore, even if a plan obtained individual genetic information about group members before GINAs 
effective date, it cannot be used to adjust the group premium. 
Under GINA and HIPAA, a plan can charge a higher overall, blended per-participant amount based on 
the manifestation of a disease or a disorder of an individual enrolled in the plan. However, a plan cannot 
use the manifestation of a disease or disorder in one individual as genetic information about other group 
members to further increase the group premium. 
A plan can take into account the costs associated with providing benefits for covered genetic tests or 
genetic services in determining overall premium or contribution amounts. Note, under HIPAA, a plan 
cannot charge an individual more for coverage than other similarly situated individuals in the group 
based on any health factor, including a manifested disease or disorder. 
For further discussion of what manifested disease means, see Q5. 
Q8:  Can an individuals doctor or other health care provider request that the individual 
undergo a genetic test? 
Generally, yes. GINA prohibits a group health plan from requesting or requiring an individual or a 
family member of an individual to undergo genetic tests. Nonetheless, under GINA, a health care 
professional who is providing health care services to an individual can request that an individual 
undergo a genetic test. A health care professional includes but is not limited to a physician, nurse, 
physicians assistant, or technicians that provide health care services to patients. 
For example, if during the course of a routine physical exam, a physician learns that an individual has 
family medical history indicating a potential risk for Huntingtons disease, the physician can  4 
recommend that the individual undergo a related genetic test. This would not violate GINA. This would 
be true even if the doctor were employed by an HMO, so long as the physician was providing health 
care services to the individual for whom the genetic test was recommended. 
Q9:  Can a health plan obtain the results of a genetic test to make a determination regarding 
payment of a claim for benefits under the plan? 
Generally, yes. If a plan conditions payment for an item or service based on medical appropriateness 
and the medical appropriateness depends on the genetic makeup of the patient, then the plan is 
permitted to condition payment for the item or service on the outcome of a genetic test. The plan 
may also refuse payment in that situation if the patient does not undergo the genetic test. The plan 
may request only the minimum amount of information necessary to make a determination regarding 
payment. 
Q10: If a plan normally covers mammograms for participants and beneficiaries starting at 
age 40, but covers them at age 30 for individuals with a high risk of breast cancer, may 
the plan require that an individual under 40 submit genetic test results or family 
medical history as evidence of high risk of breast cancer, in order to have a claim for a 
mammogram paid? 
Generally, yes. Under GINA, a plan may request and use the results of a genetic test to make a 
determination regarding payment, as long as the plan requests only the minimum amount of 
information necessary. 
Plans may also request genetic information for the purpose of determining the medical appropriateness 
of a treatment or service. Because the medical appropriateness of the mammogram depends on the 
patients genetic makeup, the minimum amount of information necessary for determining payment of 
the claim may include the results of a genetic test or the individuals family medical history. 
Q11: Can a plan request that a participant or beneficiary undergo a genetic test for research 
purposes? 
Under GINA, a plan is permitted to request, but not to require, that a participant or beneficiary 
undergo a genetic test for research purposes if the following four requirements are met: 
 The plan makes the request pursuant to research. (Research is defined in 45 CFR 46.102(d).)  
The research must comply with 45 CFR Part 46 or equivalent Federal regulations and any 
applicable State or local law or regulation for the protection of human subjects in research.
 The plan must make the request for the genetic test in writing and clearly indicate to each 
participant and beneficiary that the request is voluntary and will have no effect on 
eligibility.
 No genetic information collected pursuant to this research exception can be used for 
underwriting purposes.
 The plan must complete a copy of the Notice of Research Exception under the
Genetic Information Nondiscrimination Act and provide the notice to the address 
specified in the instructions. You can access this notice at
www.dol.gov/agencies/ebsa/employers-and-advisers/plan-administration-and-
compliance/health-plans/notice-of-research-exception-under-gina 5 
Q12: GINA prohibits a group health plan from collecting genetic information for underwriting 
purposes. What does underwriting purposes mean? 
Under GINA, the definition of underwriting purposes is broader than merely activities relating to 
rating and pricing a group policy. Under GINA, underwriting purposes means, with respect to a group 
health plan: 
 Rules for or determination of eligibility (including enrollment and continued eligibility) for
benefits under the plan or coverage (including changes in deductibles or other cost-sharing
mechanisms in return for activities such as completing a health risk assessment (HRA) or
participating in a wellness program);
 Computation of premium or contribution amounts under the plan (including discounts,
rebates, payments in kind, or other premium differential mechanisms in return for
activities such as completing an HRA or participating in a wellness program);
 The application of any preexisting condition exclusion under the plan; and
 Other activities related to the creation, renewal, or replacement of a contract of health
insurance or health benefits.
Q13: Can a plan require an individual to complete a health risk assessment (HRA) prior to or 
as part of the enrollment process for the plan? 
GINA prohibits a plan from collecting genetic information (including family medical history) prior to or 
in connection with enrollment. Thus, under GINA, plans must ensure that any HRA conducted prior to 
or in connection with enrollment does not collect genetic information, including family medical history. 
Under GINA, there is an exception for genetic information that is obtained incidental to the collection of 
other information, if 1) the genetic information that is obtained is not used for underwriting purposes 
and 2) if it is reasonable to anticipate that the collection will result in the plan receiving health 
information, the plan explicitly notifies the person providing the information that genetic information 
should not be provided. 
Therefore, a plan conducting an HRA prior to or in connection with enrollment, should ensure that the 
HRA explicitly states that genetic information should not be provided. 
Q14: Can a plan require that an individual complete a health risk assessment (HRA) that 
requests family medical history in order to receive a wellness program reward, such as 
a financial incentive, in return for the completion of the HRA? 
GINA prohibits a plan from collecting genetic information (including family medical history): 
 prior to or in connection with enrollment; or
 at any time for underwriting purposes.
Because completing the HRA results in a reward, the request is for underwriting purposes and is 
prohibited. 
A plan may use an HRA that requests family medical history, if it is requested to be completed after 
and unrelated to enrollment and if there is no premium reduction or any other reward for completing 
the HRA.  6 
 
A plan may offer a premium discount or other reward for completion of an HRA that does not request 
family medical history or other genetic information, such as information about any genetic tests the 
individual has undergone. 
The plan should ensure that the HRA explicitly states that genetic information should not be provided. 
This is because GINA provides an exception for genetic information that is obtained incidental to the 
collection of other information, if 1) the genetic information that is obtained is not used for 
underwriting purposes and 2) if in connection with any collection it is reasonable to anticipate that 
health information will be received, the collection explicitly states that genetic information should not 
be provided. 
Plans may use two separate HRAs; one that collects genetic information, such as family medical history, 
which is conducted after and unrelated to enrollment and is not tied to a reward, and another HRA that 
does not request genetic information, which can be tied to a reward. In addition, under GINA group 
health plans may also reward: 
  Participation in an annual physical examination with a physician (or other health care 
professional) who is providing health care services to the individual, even if the physician 
may ask for family medical history   as part of the examination; 
  More favorable cost-sharing for preventive services, including genetic screening; and 
  Participation in certain disease management or prevention programs. The incentives to 
participate in such programs must also be available to individuals who qualify for the 
program but have not volunteered family medical history information through an HRA.