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In Comments to GINA Rule, GPPC Tries to Clarify Debate Around 'Underwriting' for Wellness Programs

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By Turna Ray

Amid ongoing debate that the definition of "underwriting" in the Genetic Information Non-discrimination Act is too broad and might jeopardize enrollment in disease management programs, Johns Hopkins University's Genetics & Public Policy Center has issued commentary to help health plans and employers parse the complexities of implementing the law.

President George W. Bush signed GINA into law last year. The interim final rules for GINA were developed by the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury, and published in the Federal Register Oct. 7. The departments are accepting public comments on the interim final rules until Jan. 5, 2010, but the law went into effect on Dec. 7.

Meanwhile, DMAA: The Care Continuum Alliance, representing more than 200 corporations and individual members, has requested the government delay the implementation of GINA until an inter-agency investigation determines how the law's restriction on the use of genetic information for "underwriting" purposes would impact health risk assessments and enrollment in wellness programs. It is the coalition's view that the law's definition of "underwriting" overreaches Congressional intent, and the group has asked members of the Senate to provide further clarification in this regard [see PGx Reporter 12-02-2009].

In an attempt to help guide healthcare stakeholders who wish to issue public comments to the interim final rule, GPPC released two model documents — one titled "Comments on HHS [Office of Civil Rights] Proposed Rule" and the other titled "Comments on [Department of Labor], HHS, Treasury Interim Final Rule" — and "encourage[s] other organizations to use these comments in whole or in part in drafting their own comments."

The latter document includes a section challenging the notion that the underwriting restrictions within GINA would hamper HRAs and wellness programs. The document commenting on the OCR's proposed rule deals with the HHS’ expansion of the new genetic information privacy standard for “any and all health plans that are governed by the [Health Insurance Portability and Accountability Act's] Administrative Simplification provisions.”

'Wellness Programs Can Thrive Under GINA'

"Exempting wellness programs from GINA, as some have suggested, would create an enormous loophole for insurers and employers alike to have access to individual’s genetic information," GPPC states in the DoL document. "There is no need for such a loophole," it adds.

"We believe that wellness programs can continue to grow and thrive under GINA, and that the provisions related to wellness programs should remain unchanged."

Similarly, Amy Miller of the Personalized Medicine Coalition has pointed out that "as long as providing genetic information to employers is voluntary, GINA promotes wellness programs by protecting individuals against discrimination." The PMC does not support any delays in implementing GINA.

According to a Harris Interactive survey, 57 percent of employers with 500 or more employees and 16 percent of small businesses provide wellness programs for their workers, hoping to use disease management and preventative strategies to reduce healthcare costs. In an effort to tailor these programs to the individual, employers and health plans often issue HRAs, which request family health history information. Employers and health plans also offer financial incentives for completing HRAs, such as adjusting employee premiums.

PMC, GPPC and others who do not support a moratorium on GINA implementation believe that providing financial incentives for participating in a wellness program that requests genetic information would unduly influence a person into revealing such data to employers or insurers.

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Underwriting — defined as making coverage and benefits decisions, determining premium amounts, and applying pre-existing condition exclusions under a plan — using personal genetic information or family health history is prohibited under GINA.

"The regulation clearly prohibits insurers from offering discounts, rebates, payments in kind, or the imposition of punitive measures related to an individual completing a HRA or participating in a wellness program," the GPPC notes. "The rule does not provide any exceptions; any reward or benefit given for the completion of an HRA or participation in a wellness program that collects family history violates GINA."

Not only does GINA make it illegal to collect genetic and family information as part of an HRA (with or without financial incentives), but such assessments must include an explicit statement that genetic information should not be provided if one is asked a general question such as, “Is there anything else you wish to share about your health?” the GPPC cautions. These types of explicit statements will limit the chances of "incidental" collection of genetic information, which is not illegal under GINA.

Under the rules’ approach to incidental collection of genetic information, in the absence of such a statement any genetic information collected will violate GINA.

Rick Schatzberg of Generation Health, a genetic testing benefit management firm, has also pointed out that it may be possible to offer wellness programs without violating GINA by separating personal medical questions from genetic and family history questions. Generation Health, a company that is working with employers, insurers, and pharmacy benefit managers to offer genetic testing within their systems, is not opposed to seeing clarifications made to the definition of “underwriting” in GINA, but feels it is not beneficial to delay implementation of the law.

GPPC points out that Title II of GINA requires that "the implementation of wellness programs outside the insurance context — in which the employer directly contracts with a third-party provider for the wellness program — must be done on a voluntary basis." Final rules from the Equal Employment Opportunity Commission are expected to interpret and clarify what is meant by “voluntary."

In its collaboration with CVS Caremark, Generation Health will serve as a third-party provider of genetic testing services. Although Generation Health will discuss individuals' genetic risk data with doctors and genetic counselors, insurers and employers will be blinded to this information in situations mandated by GINA [see PGx Reporter 11-11-2009].

GINA "not only prohibits the discriminatory use of genetic information, but also aims to prevent such use by strictly limiting the collection and acquisition of genetic information by employers and insurers to narrow circumstances where it is needed," GPPC states in its model document. There are gaps in the law, however. For example, GINA doesn't forbid insurers from collecting and using for underwriting purposes genetic information for a pre-existing condition.

"We believe that changes [to underwriting restrictions] would be a tremendous mistake and would be counter to the plain language of GINA," GPPC said.

Extension of Privacy Protections

While GINA requires HHS to change privacy rules to prohibit health plans from using or disclosing genetic information for underwriting purposes, Title I specifies that only certain plans will be subject to this prohibition. OCR extends this prohibition to all health plans, including long-term care policies and employee benefit welfare plans, governed by the Privacy Rule under HIPAA.

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The HIPAA Privacy Rule establishes standards for protecting individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and providers that conduct certain healthcare transactions electronically. According to HHS, OCR's interpretation of GINA's underwriting restrictions is consistent with HHS' authority under the Health Insurance Portability and Accountability Act.

"We expect that the department will receive comments objecting to its approach with regards to other insurance markets," the GPPC states in its comments to the OCR proposed rule.

GPPC estimates that 16 states already regulate the use of genetic information in disability insurance, and 10 states regulate its use in long-term care insurance.

"Although state approaches vary widely, the number of states acting in this area clearly has increased in recent years and the number is likely to continue to climb. As states move forward, we believe it is appropriate for the federal government to move forward as well," GPPC states.

However, GPPC urged all government agencies implementing Title I to ensure that this proposal does not "negatively affect how GINA is implemented in the health insurance markets," and to monitor the impact of this rule on the long-term care and disability income insurance markets.

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