Summary of Federal Laws
|Associate VP for Human Resources|
Equal Employment Opportunity
Genetic Information Nondiscrimination Act of 2008 (GINA)
Title I of the Law amends portions of the Employee Retirement Income Security Act (ERISA), the Public Health Service Act, and the Internal Revenue Code, and addresses the use of genetic information in health insurance. Title II prohibits the use of genetic information in employment, prohibits the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements.
Title II applies to private and state and local government employers with 15 or more employees, employment agencies, labor unions, and joint labor-management training programs. It also covers Congress and federal executive branch agencies.
Genetic information includes, for example, information about an individual's genetic tests, genetic tests of a family member, and family medical history. Genetic information does not include information about the sex or age of an individual or the individual's family members, or information that an individual currently has a disease or disorder. Genetic information also does not include tests for alcohol or drug use.
Title II of GINA prohibits use of genetic information in making decisions related to any terms, conditions, or privileges of employment, prohibits covered entities from intentionally acquiring genetic information, requires confidentiality with respect to genetic information (with limited exceptions), and prohibits retaliation.
Final Rule, 81 Fed. Reg. 31143, May 17, 2016
This final rule amends the regulations relating to employer sponsored wellness programs. The rule the 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.
The provisions of the final rule 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 rule. For example, if the health plan that is used to calculate the permissible inducement limit begins on January 1, 2017, that is the date on which the rules governing inducements apply to the employer-sponsored wellness program. If the plan used to calculate the level of inducements begins on March 1, 2017, then March 1, 2017 is the date on which the wellness program begins.
This rule applies only where a portion of the inducement offered within a wellness program is for an employee's spouse to answer questions about his or her current or past health status or to take a medical examination. GINA does not apply to inducements made available in exchange for an employee's spouse engaging in certain activities that do not require obtaining information about current or past health status, such as attending a weight loss or nutrition program or exercising a certain amount each week. However, inducement limits and a requirement to provide a reasonable alternative standard may apply to some of these programs under HIPAA, as amended by the Affordable Care Act.
The EEOC also issued final interpretive guidance under the ADA to address employee incentives to encourage employees to participate in wellness programs when disability related inquiries are made.
The EEOC provided guidance in connection with issuance fo the rule. See also Littler summary entitled "EEOC issues Final Rules on Wellness Programs" for a summary. For a wellness program to be voluntary, an employer cannot require an employe to participate, nor can the employer deny health coverage for non-participation or limit benefits.
Proposed Rule, 80 Fed. Reg. 66853, Ocotober 30, 2015
Amending the regulations implementing Title II of the Genetic Information
Nondiscrimination Act of 2008 as they relate to employer wellness programs. The proposed regulations address the extent to which an employer may offer an employee inducements for the employee's spouse
who is also a participant in the employer's health plan to provide information about the spouse's current or past health status as part of a health risk assessment administered in connection with the employer's offer of health services as part of an employer-sponsored wellness program.
The objective of the proposed regulations is to clarify that GINA does not prohibit employers from offering limited inducements as long as "the provision of genetic information [is] voluntary and the individual from whom the genetic information is being obtained provides prior, knowing, voluntary and written authorization."
Final Regulations under the Genetic Information Nondiscrimination Act
75 Fed. Reg. 68911(November 9, 2010) Effective January 10, 2011.
The final rule provides specific definitions and clarifies other issues, such as how an employer can avoid *inadvertently* acquiring genetic information and how the rule relates to wellness programs. For more see the Quarles and Brady Labor and Employment Law Alert of November 2010 titled EEOC Releases Final Rule on Genetic Discrimination.
*Genetic information* is defined as information about:
(i) An individual's genetic tests;
(ii) The genetic tests of that individual's family members;
(iii) The manifestation of disease or disorder in family members of the individual (family medical history);
(iv) An individual's request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or a family member of the individual; or
(v) The genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.
Genetic information does not include information about the sex or age of the individual or the sex or age of family members or information about the race or ethnicity of the individual or family members not derived from a genetic test.
The final rule includes definitions of genetic monitoring, genetic services and genetic tests.
(d) Genetic monitoring means the periodic examination of employees to evaluate acquired modifications to their genetic material, such as chromosomal damage or evidence of increased occurrence of mutations,
caused by the toxic substances they use or are exposed to in performing their jobs, in order to identify, evaluate, and respond to the effects of, or to control adverse environmental exposures in the workplace.
(e) Genetic services. Genetic services means a genetic test, genetic counseling (including obtaining, interpreting, or assessing genetic information), or genetic education.
(f) Genetic test--(1) In general. ``Genetic test'' means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.
(2) Genetic tests include, but are not limited to:
(i) A test to determine whether someone has the BRCA1 or BRCA2 variant evidencing a predisposition to breast cancer, a test to determine whether someone has a genetic variant associated with hereditary nonpolyposis colon cancer, and a test for a genetic variant for Huntington's Disease;
(ii) Carrier screening for adults using genetic analysis to determine the risk of conditions such as cystic fibrosis, sickle cell anemia, spinal muscular atrophy, or fragile X syndrome in future offspring;
(iii) Amniocentesis and other evaluations used to determine the presence of genetic abnormalities in a fetus during pregnancy;
(iv) Newborn screening analysis that uses DNA, RNA, protein, or metabolite analysis to detect or indicate genotypes, mutations, or chromosomal changes, such as a test for PKU performed so that treatment can begin before a disease manifests;
(v) Preimplantation genetic diagnosis performed on embryos created using invitro fertilization;
(vi) Pharmacogenetic tests that detect genotypes, mutations, or chromosomal changes that indicate how an individual will react to a drug or a particular dosage of a drug;
(vii) DNA testing to detect genetic markers that are associated with information about ancestry; and
(viii) DNA testing that reveals family relationships, such as paternity.
An important section of the final rule, with a safe harbor for employers, is set forth below:
Sec. 1635.8 Acquisition of genetic information.
(a) General prohibition. A covered entity may not request, require, or purchase genetic information of an individual or family member of the individual, except as specifically provided in paragraph (b) of this section. ``Request'' includes conducting an Internet search on an individual in a way that is likely to result in a covered entity obtaining genetic information; actively listening to third-party conversations or searching an individual's personal effects for the purpose of obtaining genetic information; and making requests for information about an individual's current health status in a way that is likely to result in a covered entity obtaining genetic information.
(b) Exceptions. The general prohibition against requesting, requiring, or purchasing genetic information does not apply:
(1) Where a covered entity inadvertently requests or requires genetic information of the individual or family member of the individual.
(i) Requests for Medical Information:
(A) If a covered entity acquires genetic information in response to a lawful request for medical information, the acquisition of genetic information will not generally be considered inadvertent unless the covered entity directs the individual and/or health care provider from whom it requested medical information (in writing, or verbally, where the covered entity does not typically make requests for medical information in writing) not to provide genetic information.
(B) If a covered entity uses language such as the following, any receipt of genetic information in response to the request for medical information will be deemed inadvertent: ``The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of an individual or family member of the individual, except as specifically allowed by this law. To comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. `Genetic information' as defined by GINA, includes an individual's family medical history, the results of an individual's or family member's genetic tests, the fact that an individual or an individual's family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual's family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.''
updated 9-20-16 to add Final Rule on Wellness Programs