GENETIC INFORMATION NONDISCRIMINATION ACT Health Insurance Title I Employment Title II Why GINA?

What is Genetic Information? Information about: A person’s genetic tests Genetic tests of a person’s family members Disease or disorder in a family member ( family history)

What is NOT Genetic Information? Information about: Sex or Age Routine tests such as cholesterol tests Analysis of infectious agents such as bacteria, viruses, or HIV.

Prohibitions on Health Insurers Discrimination: 1) Prohibits group and individual health insurers from using a person’s genetic information in setting eligibility or premium or contribution amounts. 2) Prohibits group and individual health insurers from considering genetic information as a pre-existing condition.

Prohibitions on Health Insurers Privacy: 1) Prohibits health insurers from requesting or requiring that a person undergo a genetic test 2) Prohibits health insurers from asking about genetic information as part of the application process. 3) Once a person is covered, prohibits health insurers from requesting or requiring a person's genetic information for "underwriting purposes" -- for example, to determine whether to raise premiums when an individual renews his or her coverage.

GINA prohibits employment discrimination based on the genetic information of the employee Applies equally to employers, employment agencies, labor organizations and joint labor-management committees controlling job training Discrimination includes: “ fail or refuse to hire…discharge.. or otherwise discriminate…with respect to the compensations, terms, conditions, or privileges of employment.”

GINA makes it an unlawful employment practice for an employer to: “Request, require or purchase genetic information with respect to an employee or family member of an employee”

Exceptions to the prohibition on acquisition of genetic information: 1. Inadvertently request 2. Health or genetic services 3. Genetic monitoring of the biological effects of toxic substances 4. Federal or state FMLA compliance 5. Commercially and publicly available records 6. Law enforcement

GINA prohibits the disclosure of genetic information Genetic information must be kept as part of the employee confidential medical record

Exceptions to prohibitions on disclosure 1. Written request of the employee 2. Health research 3. In response to a court order 4. FMLA compliance 5. Information of a manifested disease or disorder that poses imminent hazard of death or life threatening illness

GINA Enforcement and Remedies Title II (Employment) Consistent with Federal Civil Rights Legislation EEOC Complaint Civil Action (After Exhaustion) Penalties Under 15 Employees- Not Covered Employees- $50, Employees- $100, Employees- $200,000 Over 500 Employees-$300,000 All Penalties are Maximum Attorneys fees are recoverable

GINA Enforcement and Remedies Title I (Health Insurance) Authorizes the Secretaries of Labor and HHS to impose a penalty for any failure to meet requirements of this Act. Federal fallback authority is granted for states failing to enforce provisions of this law.

EEOC Final Rule Implementing GINA Offers an Expansive View of GINA Definitions: 1)Employee: Clarified to include applicants and former employees 2) Family member: Clarified to include relationships through marriage, birth, adoption or placement for adoption. 3) Genetic Test: Expanded and clarified to ensure carrier screening for adults, newborn screening, ancestry and paternity testing etc. were formally acknowledged. 4) Manifested disease: Clarified the definition so that individuals whose diagnosis was principally based on genetic information would remain protected by the law and that individuals who had manifested a genetically based disease continued to have their genetic information protected.

EEOC Final Rule Implementing GINA Privacy Specific or deliberate intent is not required to trigger protections under GINA. Actions that are “likely to result” in the acquisition of genetic information are protected. Exceptions: 1) Wellness Programs: Provision of genetic information must be completely voluntary and no financial incentives can be offered to induce such. Furthermore, individuals who do not wish to provide their genetic information must be allowed alternative ways to qualify for participation in tailored programs. 2) Commercially and Publicly Available: Exception does not apply to materials made available to the public, or to some portion of the public, on a restricted basis (i.e., when more than simple registration is required for access). Exception does not apply to publicly available materials accessed with the intent of obtaining genetic information such as the conducting of Internet searches on an individual in a manner likely to result in the obtaining of genetic information.

EEOC Final Rule Implementing GINA Exceptions: 3) Inadvertent Disclosure and Safe-Harbor Language: The Regulations impose an affirmative duty on employers and other covered entities to prevent acquiring genetic information. Employers are required under GINA to affirmatively inform healthcare providers not to collect genetic information as part of a medical examination intended to determine an individual's ability or fitness for work. The final regulations include specific safe-harbor provision language to include on forms or questionnaires in which a lawful request for medical information is made. Acquisition of genetic information subsequent to proper use of safe harbor language will trigger the exception

GINA and State Law GINA does NOT pre-empt state law 48 states have genetic discrimination in health insurance laws 34 states have genetic discrimination in employment laws

State laws are generally more limited in scope than GINA For example 1)employer-sponsored health benefit plans are not covered ( Federal) 2) Many state laws have limited definitions of genetic information and do not cover family history. They may, though, offer a larger potential recovery

State laws covering other forms of genetic discrimination Life Insurance: 16 states Disability Ins: 16 states Long Term Care Ins: 10 states Several states, such as MA and CA inc protections in all 3 categories CalGINA has the broadest coverage of any state law, protecting against misuse of genetic information in housing, education, mortgage lending, elections and a variety of other contexts.

GINA Enforcement and Litigation EEOC Enforcement Statistics: 201 complaints filed in 2010, 245 in Case Example: EEOC v. Nestle Employee alleged that Nestle required him to complete a “fitness-for-duty” medical examination, that the medical examination included collection of his family medical history, and that his employer terminated his employment within one month of the medical examination. EEOC issued a subpoena directing Nestle to disclose company documents showing employment decisions involving any employee or other person who, at Nestle’s request, was subjected to a medical examination including hiring and firing decisions with respect to such individuals. Nestle refused and the EEOC petitioned to enforce the subpoena. Court rejected the petition, holding that the information the EEOC sought to obtain was “irrelevant to the charge being investigated.”

Americans’ Concern about the Privacy of Their Genetic Information Reaches New High Americans who are concerned about how their genetic information would be stored and who would have access to that information, has climbed from 65% in 2006 to an all-time high of 71% in When asked about specific entities individuals cited concerns with health insurance companies, life insurance companies, the government, and employers. Fewer than one in five Americans (16%) are aware of any laws that protect the privacy of their genetic information. Three out of four Americans (77%) say they are unsure whether they are protected. An additional 8% assert that no such protections exist. Similarly, 81% of physicians said they were not familiar with GINA. SOURCE: COGENT RESEARCH JANUARY 2011

The Genetic Information Nondiscrimination Act “The first civil rights bill of the new century” -Senator Edward Kennedy