Washington D.C. Employment Law Update : Washington D.C. Employment Lawyer & Attorney : Littler Mendelson Law Firm : Virginia, Tyson's Corner

In general, Title I of GINA prohibits group health plans and health insurance issuers from adjusting contribution amounts or premiums for the group based on the genetic information of any plan participant, prohibits plans from requesting or requiring individuals or their family members to undergo a genetic test and from requesting, requiring or purchasing genetic information for underwriting purposes or prior to an individual's enrollment.

The interim rules, among other things, define a number of terms in GINA. The new rules explain that “genetic information,” with respect to an individual, is defined as information about the individual’s genetic tests or the genetic tests of family members, the manifestation of a disease or disorder in family members of such individual (i.e. family medical history), or any request of or receipt by the individual or family members of genetic services. The definition further clarifies that genetic information does not include information about the sex or age of any individual. In addition, the regulations explain how GINA applies to genetic information about a fetus or embryo.

The prohibitions described above, when read in conjunction with the Act’s broad definition of genetic information, impose significant limitations on employers’ requests that employees complete a health risk assessment. Under the new rules, employers may not ask an employee to complete a health risk assessment that contains questions about family history until after the effective date of coverage. After coverage goes into effect, employers cannot request completion of such an assessment if they offer any premium differential, such as a reduction in the employee’s contribution.

For purposes of Title I only, the regulations adopt the definition of “genetic test” from the statute, which defines such a test as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if it detects genotypes, mutations, or chromosomal changes.” The regulations point out that this definition of “genetic test” differs from that contained in Title II of GINA, which governs genetic discrimination in employment. 

In regard to GINA’s impact on HIPPA, the Department of Health and Human Services (HHS) has also published in the Federal Register a proposed rule (pdf) interpreting Section 105 of GINA, which requires HHS to revise the HIPPA privacy regulations to clarify that genetic information is health information under the rule and prohibits the use or disclosure of genetic information for underwriting purposes. According to HHS’ proposal, the rules modify the HIPAA Privacy Rule to: (1) explicitly provide that genetic information is health information for purposes of the Rule; (2) prohibit health plans from using or disclosing protected health information that is genetic information for underwriting purposes; (3) revise the provisions relating to the Notice of Privacy Practices for health plans that perform underwriting; (4) make a number of conforming modifications to definitions and other provisions of the Rule; and (5) make technical corrections to update the definition of “health plan.”

In its commentary to the regulations, HHS pointed out that the change to the Privacy Notice would be material and, therefore, would require notification of the change to the named insured or the named plan participant. HHS requested further comment on how this notification could be accomplished in a manner that would be less burdensome and expensive than distributing a revised Privacy Notice. Employers should watch for additional guidance on this issue.

The IRS’ proposed rule (pdf) cross-references the interim rules, which prohibit using an individual’s genetic information to adjust group premium or contribution rates.

Comments on the interim final rules must be made by January 5, 2010, and can be submitted electronically through the federal eRulemaking Portal:http://www.regulations.gov, to any of the agencies involved in this rulemaking. Comments to the DOL can also be make via email: E-OHPSCA.EBSA@dol.gov. Written comments to the DOL may also be sent or hand-delivered to: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention: RIN 1210-AB27. All comments to the DOL must include the identification number: RIN 1210-AB27.

Comments submitted to the CMS must be identified with CMS-4137-IFC, and can be sent to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4137-IFC, P.O. Box 8017, Baltimore, MD 21244-8010. Hand-delivered comments may be brought to either 7500 Security Boulevard, Baltimore, MD 21244-1850 or Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC 20201.

Comments to the IRS are to be sent to: CC:PA:LPD:PR (REG-123829-08), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Hand-delivery may be made to: CC:PA:LPD:PR (REG-123829-08), Courier’s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW, Washington DC 20224. Comments to the IRS must be identified with: REG-123829-08.

Written comments (one original and two copies) on the HHS proposed rule must be received by December 7, 2009 at the following address: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: GINA NPRM (RIN 0991-AB54), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, S.W., Washington, D.C. 20201. 

Philip L. Gordon contributed to this entry.
 

The EEOC will also move forward with regulations regarding the equal employment provisions of the Americans With Disabilities Act Amendments Act (ADAAA).  The ADAAA, enacted in 2008, expanded the definition of “disability” under the Americans with Disabilities Act (ADA) in light of a number of Supreme Court decisions. In December 2008, the EEOC commissioners deadlocked along party lines on whether to approve former Chair Naomi Earp’s proposed regulations.  According to the EEOC’s agenda, a notice of proposed rulemaking will be issued by August of this year.

The Age Discrimination in Employment Act (ADEA) will be subject to two rules as a result of the Supreme Court’s decisions in Smith v. City of Jackson and Meacham v. Atomic Knolls Laboratory. In Smith, the Court held that an employer could defend against a disparate impact claim under the ADEA by showing that its alleged adverse employment decision was due to reasonable factors other than age. In Meacham, the Court ruled that employers bear the burden of providing this defense. The proposed regulations, therefore, address this disparate impact burden of proof under the ADEA.  Final regulations on this issue are expected by March of 2010.  In addition, the EEOC intends to publish a notice of proposed rulemaking to amend its current regulations on what constitutes “reasonable factors other than age” by August of this year.

In a more procedural vein, the EEOC intends to issue a notice of proposed rulemaking by the end of next month to make changes and corrections to the federal sector equal employment opportunity complaint process. The agency also plans to revise its race and ethnicity data collection method to make employee self-identification the preferred method for collecting such data to conform with current reporting instructions for the EEO-1 Report.

GINA was enacted on May 21, 2008 as Pub. L. 110-233, and codified at 42 U.S.C. 2000ff et. seq. Title I of GINA applies to group health plans sponsored by private employers, unions, and state and local government employers, among other entities. Title II prohibits genetic discrimination in the employment context, prohibiting the deliberate acquisition and disclosure of genetic information by employers. Title II also prevents employers from making adverse employment decisions based on an employee’s or applicant’s genetic information. In drafting implementing regulations for GINA, the EEOC borrowed many terms and concepts it has used for other employment anti-discrimination laws, such as the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act.

The GINA proposed regulations are divided into 12 sections that will ultimately be codified at 29 C.F.R. § 1635. Although all areas are eligible for comment, the EEOC is seeking input in a few specific areas; particularly those the EEOC acknowledges certain terms and concepts that are unique to GINA which are outside the EEOC’s scope. In addition to consulting with the National Human Genome Research Institute, the EEOC is inviting comments regarding certain definitions particular to GINA. Of note, the definition of “genetic test” – an “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes” – contains terms that are not common in employment discrimination law. Other terms and phrases specific to GINA over which the EEOC welcomes comment include “family member,” “family medical history,” “genetic monitoring,” “genetic services,” and “manifestation” of a genetic condition or disease.

The regulations also clarify that a test to detect the presence of a virus that is not composed of DNA, RNA, chromosomes, proteins, or metabolites does not render it a “genetic test” under the Act, nor are drug and alcohol tests. The EEOC is seeking comment on whether other types of tests should be included/excluded from the “genetic test” umbrella.

Under GINA, an employer may not “request, require, or purchase genetic information” about an applicant or employee. One of the six exceptions to this rule under the Act includes any voluntary disclosure. The EEOC therefore seeks comment about how this voluntary exception would apply to a voluntary employer-provided wellness program.

GINA also makes an exception for the purchase of commercially and publicly available material that may include a family medical history. The regulations explain, for example, that an employer would not violate GINA if it discovered an employee had the breast cancer gene by reading an article profiling individuals who knew they had that gene. The statute provides a list of media sources that may make an individual’s genetic information publicly available, such as newspapers, magazines, periodicals, and books. The regulations add to that list information obtained through electronic media, such as the Internet, television, and movies. The EEOC seeks input as to whether other types of sources should be added to this list.

The statute also includes a narrow exception for employers that engage in DNA testing for law enforcement purposes as a forensics lab or for purposes of human remains identification. Under GINA, these employers may request or require “genetic information of such employer’s employees, apprentices, or trainees, but only to the extent that such genetic information is used for analysis of DNA identification markers for quality control to detect sample contamination and maintained in a manner consistent with such use.” The EEOC thus seeks public comment on how this exception would impact law enforcement.

With respect to the protections offered under Title I of GINA, the regulations explain that if Title I offers a remedy for a special insurance-related practice or act, then that practice or act cannot be challenged and no remedy may be sought under Title II.

The regulations also emphasize that some of the employer inquiries that are deemed permissible under the ADA are now unlawful under GINA. For example, the ADA had permitted employers under certain circumstances to obtain medical information – including genetic information – from post-offer applicants. GINA, however, proscribes the solicitation of any genetic information, including family medical history, from such applicants or employees, except under very limited circumstances.

Finally, the regulations explain the interplay between GINA and other employment laws, including the ADA and the Family and Medical Leave Act (FMLA)

Comments on these proposed regulations may be sent by mail to Stephen Llewellyn, Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, 131 M Street, NE., Suite 6NE03F, Washington, DC  20507, or by facsimile (six or fewer pages only) to (202) 663-4114. Alternatively, comments may be submitted online at http://www.regulations.gov. All comment submissions must include the agency name (EEOC) and docket number or the Regulatory Information Number (RIN): 3046-AA84.

According to the EEOC, the typical human resources professional will need to dedicate, at most, three hours to gain a satisfactory understanding of the new requirements imposed under GINA. For more information on GINA, see Littler’s ASAP: Genetic Antidiscrimination Law Creates New Compliance Challenges for Employers by: Philip L. Gordon and Jennifer L. Mora.