New restrictions on the collection, use and disclosure of genetic information applicable to employer and union-sponsored group health plans enacted under Title I of the Genetic Information Nondiscrimination Act of 2008, Public Law No. 110-233 (GINA) for group health plan years that begin on or after today (May 21, 2009). For non-calendar year plans with plan years beginning between June 1 and December 1, the effective date occurs on first day of their 2009 plan year. For example, the effective date will be June 1, 2009 for a plan with a 2009 plan year that begins June 1.  For calendar year plans, the compliance deadline is January 1, 2010.   All employer-sponsored group health plans are required to comply with GINA.  There are no small group exceptions.

GINA In A Nutshell

GINA amended federal law to include specific prohibitions against certain discrimination based on genetic information by group health plans and health insurers (Title I) and to prohibit discrimination based on genetic information by employers of 15 or more employees (Title II).

Effective for all group health plan years beginning on or after May 21, 2009, GINA’s new restrictions on the collection and use of genetic information by group health plans added under Title I of GINA are accomplished through the expansion of a series of already existing group health plan nondiscrimination and privacy rules.  GINA’s group health plan provisions amend and expand the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Employee Retirement Income Security Act of 1974 (ERISA), Title VII of the Civil Rights Act, the Public Health Service Act, the Internal Revenue Code of 1986, and Title XVIII (Medicare) of the Social Security Act to implement sweeping new federal restrictions on the collection, use, and disclosure of information that falls within its broad definition of “genetic information” by  group health plans.  For individual health insurers, GINA’s restrictions take effect May 22, 2009.  The broad definition of the term “genetic information” in GINA will require group health plan sponsors and insurers to carefully review and update their group health plan documents, communications, policies and practices to comply with forthcoming implementing regulations to avoid liability under new GINA’s rules governing genetic information collection, use, protection and disclosure in a series of areas. 

Meanwhile, employers, unions and others face their own new prohibitions against genetic information based employment discrimination added by Title II of GINA, which take effect November 21, 2009. The Equal Employment Opportunity Commission (EEOC) published proposed regulations interpreting Title II of GINA in March, 2009.

Broad Definition of “Genetic Information”

The broad range of information included within GINA’s broad definition of “genetic information” means its new restrictions have a sweeping reach when applied to most group health plans.  GINA defines “genetic information to include with respect to any individual, information about:

• Such individual’s genetic tests;
• The genetic tests of family members of such individual; and
• The manifestation of a disease or disorder in family members of such individual.

GINA also specifies that any reference to genetic information concerning an individual or family member includes genetic information of a fetus carried by a pregnant woman and an embryo legally held by an individual or family member utilizing an assisted reproductive technology.

Pending issuance of regulatory guidance, GINA’s inclusion of information about the “manifestation of a disease or disorder in family members” raises potential challenges for a broad range of group health plan health assessment and other wellness and disease management programs which provide financial incentives or condition eligibility on the provision of family health histories or other information that could be construed as genetic information. 

Group Health Plan Genetic Testing Collection and Nondiscrimination Rules

Under GINA’s nondiscrimination rules, group health plans and health insurers may not:

• Request, require or purchase genetic information for underwriting purposes or in advance of an individual’s enrollment;
• Adjust premiums or contribution amounts of the group based on genetic information;
• Request or require an individual or family member to undergo a genetic test except in limited situations specifically allowed by GINA;
• Impose a preexisting condition exclusion based solely on genetic information, in the absence of a diagnosis of a condition;
• Discriminate against individuals in eligibility and continued eligibility for benefits based on genetic information; or
• Discriminate against individuals in premium or contribution rates under the plan or coverage based on genetic information, although such a plan or issuer may adjust premium rates for an employer based on the manifestation of a disease or disorder of an individual enrolled in the plan.

GINA also prohibits insurers providing individual health insurance from establishing rules for eligibility, adjusting premiums or contribution amounts for an individual, imposing preexisting condition exclusions based on, requesting or requiring individuals or family members to undergo genetic testing.

Of particular concern to many plan sponsors and fiduciaries are the potential implications of these new rules on existing wellness and disease management features group health plans. Of particular concern is how regulators will treat the collection of family medical history and certain other information as part of health risk assessments used in connection with these programs. Although official guidance is still pending, many are concerned that regulators will construe certain commonly used practices of requiring covered persons to provide family medical histories or other genetic information through health risk assessments (HRAs) to qualify for certain financial incentives as a prohibited underwriting practice under GINA.  Even where health risk assessments are not used, however, most group health plan sponsors should anticipate that GINA will require specific amendments to their plan documents, communications and processes.

Taking timely action to comply with these nondiscrimination and collection prohibitions is important.  Under amendments to ERISA made by GINA, group health plan noncompliance can create significant liability for both the plan and its sponsor.  Participants or beneficiaries will be able to sue noncompliant group health plans for damages and equitable relief.  If the participant or beneficiary can show an alleged violation would result in irreparable harm to the individual’s health, the participant or beneficiary may not have to exhaust certain otherwise applicable Department of Labor administrative remedies before bringing suit.  In addition to these private remedies, GINA also authorizes the imposition of penalties against employers and other sponsors of group health plans that violate applicable requirements of GINA of up to $500,000. The minimum penalties generally are set at the greater of $100 per day or a minimum penalty amount ranging from $2,500 for de minimus violations corrected before the health plan received notice of noncompliance to $15,000 in cases in which the violations are more than de minimus.  GINA also includes language allowing the Secretary of Labor to reduce otherwise applicable penalties for violations that could not have been identified through the exercise of due diligence or when the plan corrects the violation quickly.

GINA Amendments To Health Plan Privacy Rules Under HIPAA

In addition to its nondiscrimination rules, GINA also amends HIPAA to make clear that “genetic information” as defined by HIPAA is protected health information protected by HIPAA’s Privacy & Security Standards of HIPAA. This means that it will require that all genetic information be treated as protected health information subject to the Privacy and Security Standards applicable to group health plans covered by HIPAA. Although the statutory provisions that accomplish these changes are deceptively simple, compliance with these requirements likely will require group health plans and their business associates to amend existing privacy policies, notices and practices to appropriately restrict disclosures for underwriting, operations and certain other uses to withstand scrutiny under the GINA privacy rule amendments. 

The HITECH Act amended and increased civil penalties for HIPAA privacy violations in many circumstances effective February 17, 2009.   

Regulatory Guidance Status

 As the the deadline for compliance for post May 20, 2009 plan years is rapidly approaching, however, many group health plans and their sponsors will need forward with their compliance arrangements in the absence of regulatory guidance interpreting these requirements. 

GINA’s fractured assignment of responsibility and authority to develop, implement and enforce regulatory guidance of its genetic information rules can create confusion for parties involved in compliance efforts. Because the group health plan requirements of Title I of GINA are refinements to the group health plan privacy and nondiscrimination rules previously enacted as part of HIPAA, GINA specifically assigned authority to construe and enforce its group health plan requirements to the agencies responsible for the interpretation and enforcement of those original rules:

• The Department of Labor Employee Benefit Security Administration (EBSA);
• The Internal Revenue Services (IRS), and
• The Department of Health & Human Services. 

While these three agencies previously published a request for public comments about issues under Title I’s provisions, see http://edocket.access.gpo.gov/2008/pdf/E8-24194.pdf, none of these three agencies as of May 20, 2009 has published interim or other regulations interpreting the GINA provisions within their scope of responsibility since the formal comments period ended December 9, 2009.  Although the EBSA Spring 2009 regulatory agenda reflected it intended to publish interim regulations by today and agency officials continue to indicate they intend to publish guidance “soon,” no guidance had been published as of May 20, 2009.

Even if the agencies issue guidance by the end of May plan sponsors and administrators of group health plans with new plan years beginning in the next 60 to 90 days are expressing concern that they will have inadequate time to complete compliance arrangements.  As a result, in addition to guidance about GINA’s requirements generally, some are hopeful that the guidance with include transition rules or other relief to allow more time to comply with the regulations when finally issued.  Regulators as of May 20, 2009 had not given any indication that they plan or perceive that they are authorized to provide such relief.

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting employers with these and other labor and employment, employee benefit, compensation, and internal controls matters. If your organization needs assistance with assessing, managing or defending its wage and hour or other labor and employment, compensation or benefit practices, please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402; or your favorite Curran Tomko Tarski, LLP attorney.  For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi, LLP team, see the http://www.cttlegal.com.

Other Information & Resources

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting employers with these and other labor and employment, employee benefit, compensation, and internal controls matters. If your organization needs assistance with assessing, managing or defending its wage and hour or other labor and employment, compensation or benefit practices, please contact Ms. Stamer at e-mail, (214) 270-2402; or your favorite Curran Tomko Tarski, LLP attorney.  For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi, LLP team, see the Curran Tomko Tarski Website or Cynthia Marcotte Stamer, P.C. Website.

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