Up Next: The Genetic Information Nondiscrimination Act
By Anita K. Chancey

In May 2008, Congress overwhelming passed the Genetic Information Nondiscrimination Act (GINA) that was then signed into law by President George W. Bush on May 21, 2008.[1]  As the name suggests, this law seeks to protect an individual from discrimination based on the individual’s genetic information. A simple definition of genetic information is any information obtained from genetic testing (for screening, health care or any other reasons) or is based on family history of disease. GINA prevents health plans and health insurance issuers (health insurers) from using genetic information when determining coverage, premiums or benefits received by an individual.  GINA also protects employees from the improper use of such information by an employer in hiring, firing, job placement or promotion among other items.  This article explores a brief history of genetics leading up to the passage of GINA and the resulting impact GINA will have on health plans and insurers and employers.

History of Genetics

Genetics had their beginning in the mid 1800s with Gregor Mendel’s discovery that traits found in peas could be used to produce specific traits in successive crops.  Since his discovery, this technique has been used to modify both plants and animals alike. For instance, the tomato you eat has probably been modified by Mendel’s theories.  The milk cow has been bred to produce more milk.  It is because of Mendel, we learned in science class why one person had blue eyes and another brown.   

This quiet beginning in genetics by Mendel, led to the 1930s and 1940s, when scientists began to learn that genes were part of other structures, specifically DNA and RNA.  Continued study ultimately led to the discovery of the structure of DNA by James D. Watson and Francis Crick (the famous double helix).  This breakthrough led to study of the properties of specific genes, the complete sequencing (makeup) of DNA found in various bacteria, the ability to link a specific gene on human DNA to cystic fibrosis, to discovering the possible connection between genes and other disorders.  

Then, in 2003, through the Human Genome Project, the sequencing of the entire genetic makeup of human DNA was completed.[2]  At this time, scientists believe that over 15,000 human diseases and disorders have a genetic component.  Already more than 1,000 genetic tests have been developed for human conditions allowing an individual to determine his or her susceptibility.  The ability to obtain this information has caused concern that discrimination will occur.

In fact, the concerns that led to the passage of GINA (that genetic information will be misused) started with the passage in 1907 by Indiana requiring the forced sterilization on people suffering from “genetic disorders” such as mental illnesses, mental retardation, blindness, hearing loss, as well as other handicaps.  By 1981, the majority of states had passed similar laws.  Additionally, in 1927, the Supreme Court approved such sterilizations in Buck v. Bell,[3] a decision that has never been overturned.  While most states have overturned these laws, a few states continue to retain them by simply adding provisions of due process and equal protection for the individual. [4]

In the United States, Sickle Cell Anemia most commonly affects African Americans and Hispanics. In the 1970s, both states and the federal government began mandatory testing.  While other ethnic groups could develop the disease, the testing focused on African Americans.  At first it appeared that the testing arose from a desire to diagnose and treat the disease.  However, records were not kept confidential and led to discrimination against African Americans based on the results of the tests.  In some states, such testing was mandatory.  Results of such tests were not kept confidential, leading to discrimination both in employment and in health insurance.  This also appeared to be an indirect method of racial discrimination.  To end this discrimination, Congress passed the National Sickle Cell Anemia Control Act in 1972 allowing such testing if it was done only on a voluntary basis.  States that continued to do mandatory testing were subject to loss of federal funding. 

Then in 1998, Lawrence Livermore Laboratories in Berkeley was found to have been performing tests for syphilis, pregnancy and sickle cell on employees without their knowledge or consent for years.[5]  Burlington Northern Santa Fe Railroad also began genetic testing on employees to determine those who were susceptible to carpal tunnel syndrome, again without their knowledge or consent.  Though it did not appear that there had been any actual discrimination resulting from this testing, the Equal Employment Opportunity Commission in 2001 filed a civil lawsuit against the Railroad stating that such testing violated the Americans with Disability Act (ADA).[6]  While not admitting it violated the ADA, the Railroad settled the case in 2002 for $2.2 million.[7]

These incidents of the misuse of genetic information have led to the fear that more discrimination will occur especially given the advancing knowledge in the field of genetics.  There are a variety of state and federal laws in place that provide some protection against discrimination based on genetic information.[8]  However, with this quilt-work of laws, Congress passed GINA to ensure that health plans, health insurers and employers do not discriminate against individuals based on genetic information.

General Information Relating to GINA

There are two types of genetic information:  that which is obtained from genetic testing and that based on family history.  Genetic testing is being done at all levels, including prenatal testing, diagnostic testing, pre-symptomatic testing and carrier testing.  Of course, the infamous use of DNA testing cannot be overlooked.   There are frequent advertisements on both TV and the Internet that offer tests for specific disorders or provide an individual a complete sequence of his or her DNA sequence.  From that, the individual may gain information of risks that currently may be tested for or retain the tests so as to determine in the future what risks may be present.  Doctors also order genetic screening to acquire information based on a patient’s symptoms or family history, or even to ensure that a patient does not have a reaction to a particular drug.[9]  There are many reasons that genetic testing might be done.  All lead to the acquisition of genetic information.

Additionally, a person or entity may also acquire genetic information based on an individual's family history. If a person has a family history of a particular disorder or disease and it has been shown that the disorder or disease may have a genetic basis, then there is a likelihood that the person will have the same disorder or disease.  For instance, if a woman has many relatives in her family that have had breast cancer, then it is more likely the woman will also develop breast cancer.[10]  Science has shown that certain breast cancers are tied to specific genetic anomalies.  Family history includes any information that is obtained from the collection of genetic information of a fetus.  A family member includes a dependent and any individual who has a relation with the individual within four degrees (for instance, a lineal descendant that is a great, great grandfather is related to the individual within four degrees).

On the other hand, a person is not discriminated against under GINA if a disease or disorder manifests itself that has a genetic cause (other laws such as the ADA may still provide protection).  Taking the previous example, the woman who had many family members with breast cancer may suffer discrimination that is banned by GINA, but if she develops breast cancer herself, she is no longer protected by GINA.  Other commonly recognized diseases that are genetically linked include ALS, Crohn’s disease and multiple sclerosis.  Once the disease manifests itself, the insurer may raise premiums or contributions or reject an individual’s application for health insurance.

Title I – Health Plans and Insurers

Title I focuses on discrimination by health plans and insurers because of genetic information.  The first four sections cover specific health plans (Sec. 101 through Sec. 103), health insurance obtained by an individual on the private market (Sec. 102) and Medicare Supplemental Insurance (Sec. 104).[11]  Many provisions in these sections are identical.  However, each section amends a different part of the U.S. Code.  Section 101 amends the Employee Retirement Income and Security Act of 1974 (ERISA), Section 102 amends the Public Health Service Act, Section 103 amends the Internal Revenue Code of 1986 and Section 104 the Social Security Act.

As noted, there are many similar provisions in the first four sections of Title I.  These include that an individual’s premium or contribution amounts may not be adjusted because any genetic information of the individual or the individual’s family.  While genetic information may be used in determining payment of a health claim, that use must be minimal.[12]

As would be expected, a health plan or insurer may not request or require a person to undergo genetic testing.[13]  However, if the request was made as part of a research project, an individual may be asked to undergo genetic testing (but not required) if:

·                     A request is made in writing.  The research must comply with various regulations of the Secretary of Health and Human Services (HHS), the Social Security Act, and the Health Insurance Portability and Accountability Act (HIPAA). 

·                     The individual must understand that compliance is voluntary and that there will be no action against the individual who does not volunteer for the research (for instance, there may not be any mistreatment on the job).

·                     Any genetic information collected in the research cannot be used to adjust premium or contributions.

·                     Health and Human Services has to be notified of the research.

Another requirement in the first four provisions is that genetic information may not be asked for, required of or purchased on an individual for purposes of coverage or benefits.  However, if there is an incidental collection of information, then GINA is not violated.

Genetic information of a fetus or embryo of the individual or his or her family members may not be used.  This would include information gained when a woman is pregnant or obtained because of reproductive technology.

An additional requirement found in Section 102 is that the health insurer may not determine eligibility or continued eligibility of an individual based on genetic information.  An insurer may not use genetic information to set insurance rates or deny coverage to a person because of a pre-existing condition that is based on genetic information. Similarly, genetic information may not be used to deny an individual health coverage.

Penalties

The penalties in Title I vary depending on the section.  For instance, in Section 101, penalties are used to enforce the section and may be assessed against the sponsor of a group health plan or the insurer’s such plan, if one.  The amount of civil penalty that may be assessed is $100 a day for each day the plan or insurer is not in compliance with GINA.  If there is more than one penalty with respect to an individual, the minimum penalty increases $2,500 a day.  If the violation is more than de minimus, the penalty increases to $15,000 per day.  The maximum penalty that may be assessed is $500,000.

However, if the violation occurred when the entity exercised reasonable diligence but did not discover the violation, no penalty will be assessed.  Penalties are also not assessed if the failure was due to reasonable cause and not willful neglect or the failure was corrected within 30 days of when the failure should have been discovered. 
Additionally, the Secretary of the Department of Labor may waive any penalty.[14]  Section 102 has the same penalties available as found under Section 101.[15]

Under Section 103, the penalties are governed by the Internal Revenue Service (IRS).  The amount of the penalty is not set forth in GINA but instead is an excise tax that is assessed under § 4890D of the Internal Revenue Code.  GINA directs the IRS to make any conforming changes to the code necessary to enforce this provision in GINA.[16]  As with Section 103, no enforcement provisions are provided for Section 104.  However, the Secretary of Health Human Services may set forth regulations governing enforcement of GINA.

Section 105 applies the privacy rules of HIPAA.  The genetic information protected by the first four sections of Title I are also protected by HIPAA.  HIPAA covers any genetic information gathered, either inadvertently or through means such as research as well.  Similar to Section 103, Section 105 does not set forth any specific enforcement provisions or penalties.  The Secretary of Health and Human Services oversees HIPAA privacy rules and may provide that the existing enforcement provisions of HIPAA will be applied or may promulgate new or additional rules through the regulatory process.[17] 

The effective date of Sections 101-105 of Title 1 is 12 months after GINA became law on May 21, 2008.  All agencies governing these sections are to issue regulations by the effective date.  The Medicare supplement insurance coverage of GINA will also determine which states need to come into compliance with this new law.  However, if states have not issued guidance with the changes by May 21, 2009, they will not be in violation of GINA.

The various agencies overseeing Title I have been directed to coordinate both regulations and policies as they apply to the above sections.  A first step in issuing the regulations was recently completed by the Department of Labor, Internal Revenue Service and Health and Human Services.  These departments issued a request for comments On GINA.  The deadline for submitting comments were due on Dec. 9, 2008, regarding Sections 101 through 104.  This is a normal step in the regulatory process, but does not indicate when proposed or final regulations may be issued.

Title II of GINA

The focus of Title II focuses on employers and their employment practices.  As with Title I, genetic information is defined as the information from the genetic test of an individual or the genetic tests of the individual’s family members, as well as the manifestation of a disease or disorder of the individual’s family.[18]  Along with employers, employment agencies, labor organizations and training programs are covered by Title II.  The employees that are protected by GINA include:

·                     an employee (including an applicant) or a former employee,[19]

·                     a state employee except elected officials and their appointees,[20]

·                     a federal congressional employee,[21]

·                     a federal executive branch employee,[22] or

·                     a federal employee of the U.S. military, executive agencies, U.S. Postal Service employees, the judicial branch units of the government of the District of Columbia, and certain other employees of specific federal governmental entities.[23]

As with Title I, many of the provisions in Title II apply to several sections.[24]  It is unlawful for an employee to be discriminated against by failing or refusing to hire, discharging any employee, or to discriminating with respect to an employee’s compensation, terms, conditions, or privileges of employment based on genetic information.[25]  There also may not be any limitation of an individual seeking referral for any job because of the individual’s genetic information.[26]  A person’s genetic information may not be used to deny or expel labor organization membership, interfere in a training, retraining program, apprenticeship or interfere with any employment opportunities.

Additionally, an employee may not have his or her work limited, segregated or classified based on genetic information in a manner that adversely affects the status of the employee.[27]  The genetic information may not be used to limit, segregate or classify information that would deprive an individual the opportunity to obtain employment.

Genetic information may not be requested, required or purchased about an employee or the employee’s family.[28]  Exceptions to this rule include:

·                     Inadvertent request or requirement of genetic information.

·                     Genetic services provided to the employee, including those through a wellness program.

·                     The employee provides prior, written, knowing and voluntary authorization.

·                     Only the employee and a licensed health professional have access to the information.

·                     Genetic information is collected and known only in the aggregate with no personal, identifiable information.[29]

·                     Obtain genetic information of an employee or the employee’s family to comply with certification requirements of the Family and Medical Leave Act and any similar state laws.[30]

·                     Purchase genetic information that is commercially and publicly available.[31]

Information may also be collected in the workplace for genetic monitoring of the biological effects of toxic substances in the workplace.[32]  For instance, an employee may work in a scientific lab that studies a substance that may have not only a toxic effect on the employee, but also impact the employee’s genes.  The employee must receive a written notification of the testing, the employee has to provide a voluntary written authorization prior to the testing, the employee must receive the results of the tests, and the testing must comply with the Occupational Safety and Health Act of 1970 and state monitoring requirements, the Federal Mine and Health Safety Act of 1977, and the Atomic Energy Act of 1954.[33]

Section 202 and 205 provide that law enforcement may also obtain genetic information for certain purposes, such as identifying human remains, but only if no other means may achieve the purpose.[34]

Section 206 of Title II focuses on the confidentiality of genetic information.  If any entity, from an employer to a labor organization obtains genetic information, information must be treated as confidential medical information and kept on separate forms and in separate medical files consistent with the requirements of American Disability Act (42 U.S.C. 12112(d)(3)(B)).  The information may be disclosed to the employee upon written request with the informed consent of the employee in accordance with 45 C.F.R. 46.116.

Disclosure may also be made in connection with the employer’s compliance with the certification provisions of section 103 of the Family and Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements under state family and medical leave laws.  Additionally, genetic information obtained by an employer may be disclosed to a health agency if the information is related to an imminent hazard and the employee is informed of the disclosure.  Finally, under regulations promulgated by Health and Human Service regarding HIPAA privacy and under the Social Security Act, genetic information may be released as allowed under those regulations.

Damages

In general, employees are entitled to the damages, costs and fees provided by an applicable federal discrimination statute.  The applicable statutes are Title VII of the Civil Rights Act of 1964, the Government Employee Rights Act of 1991, the Congressional Accountability Act of 1995, the Extension of Certain Rights and Protections to Presidential Offices, and Section 717 of the Civil Rights Act of 1964.  All of these statutes provide for compensatory and punitive damages pursuant to Title VII, 42 U.S.C. § 1981(a).

Disparate Impact

A cause of action may not be brought based on alleged disparate impact.  However, six years after the enactment of GINA, a Genetic Nondiscrimination Study Commission will be formed consisting of:

·                     A member appointed by the majority leader of the Senate

·                     A member appointed by the minority leader of the Senate

·                     A member appointed by the chairman of the committee on health, education, labor, and pensions of the Senate

·                     A member appointed by the ranking minority member of the committee on health, education, labor, and pensions of the Senate

·                     A member appointed by the speaker of the House of Representatives;

·                     A member appointed by the minority leader of the House of Representatives;

·                     A member appointed by the chairman of the committee on education and labor of the House of Representatives

·                     A member appointed by the ranking minority member of the committee on education and labor of the House of Representatives

This committee will issue a report within one year that summarizes the findings and makes any recommendations relating to GINA.

Finally, the EEOC is to issue recommendation within one year of the effective date of GINA, May 21, 2009.  The employment provisions take effect on Nov. 21, 2009.  

The nuts and bolts of GINA may appear straightforward.  But is not necessarily straight-forward when putting GINA to work.  Regulations that will be published on all segments of GINA may either simplify or complicate GINA.  Obvious guidance is needed - for instance, how will the exception involving FMLA actually work?  While regulations often provide guidance that assists in implementing a new statute, often additional requirements are added within the regulations that are unexpected. An example of that which may be foreseen is in the area of HIPAA.  GINA applies to health plans, health insurers and employers, yet a section on HIPAA is included in those provisions.  On its face, none of the parties are HIPAA covered entities, therefore would not seem to be directly covered by GINA.  The regulations will hopefully flesh out these details.  One possibility is that every doctor and hospital will have to add some information on protection of genetic information to their HIPAA notice of privacy practices.  While not trying to bring all gloom and doom to GINA, it is very important to realize that GINA is still in its infancy and, as time passes, putting Gina to practice will become more clear.

About the Author

Anita Chancey is of counsel at Doerner, Saunders, Daniel and Anderson LLP. She graduated in 1999 from the University of Missouri. She focuses her practice on plans governed by ERISA and the IRC, including retirement plans, executive compensation and health plans, working with clients on all issues that arise with their plans. If needed, she represents employers in proceedings before the Department of Labor, the Internal Revenue Service and the Pension Benefit Guaranty Corporation.