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Policy Groups Plan to Urge Government to Clarify GINA’s Definition of 'Genetic Test'

Before it implements the Genetic Information Nondiscrimination Act in May next year, the US government needs to clarify several definitions in the law and ensure that privacy rules it codifies do not conflict with existing federal regulations, according to policy groups submitting suggestions to a request for information from the Departments of Treasury, Labor, and Health and Human Services.
The health and treasury departments, along with the Equal Employment Opportunity Commission, issued an RFI in October seeking input on issues related to implementing Title I, or the health insurance portion, of GINA. 
Johns Hopkins University’s Genetics and Public Policy Center, the Georgetown Health Policy Institute, and the National Workrights Institute have analyzed the new law and created a model document in response to the RFI. A fourth center, the Genetic Alliance, also plans to submit its own comments based on the document. The Coalition for Genetic Fairness has also announced plans to submit comments.
According to the GPPC document, the government should provide examples of the types of genetic information protected under the new law, clarify what type of genetic data related to a person’s existing condition is off limits for insurance underwriting, and create procedures outlining how the HHS and the Department of Labor will enforce the new law.
“We believe that GINA will affect few policies, procedures, or practices of group health plans and health insurance issuers,” the three groups plan to state in their comments. “The primary change will be the prohibition on use of family history in the individual health insurance market. Procedurally, for entities that are already compliant with [the Employee Retirement Income Security Act] and HIPAA, GINA imposes minimal additional requirements.” 
GINA, which became law in May, is designed to ensure that an individual’s genetic information will not be misused by insurers and employers [see PGx Reporter 05-07-2008].
However, the law doesn’t prevent genetic discrimination if such information is part of “manifest” diseases, or a person’s pre-existing conditions.
The bill also includes a “firewall” separating the potential liabilities insurers and employers could face, exempts employers from liabilities if the employer “inadvertently” garners genetic information through a company-sponsored wellness program, and requires employers to request such information in order to monitor biological effects of toxic substances in the workplace.
The Genetic Information Non-Discrimination in Employment Coalition, a group that is concerned that GINA might encourage “unmeritorious litigation,” told Pharmacogenomics Reporter that it has no plan to submit comments to the RFI for Title I.
However, if the government seeks comment for Title II, the employment discrimination portion of the law, then the group will issue comments suggesting, among other things, a more specific definition of what constitutes “inadvertent” gathering of genetic data.
GINA’s provisions will be in effect on May 21, 2009. Public comments to the RFI must be submitted by Dec. 9.
Additional Clarifications
GINA defines a “genetic test” as the “analysis of human DNA, RNA, chromosomes, proteins, or metabolites, to detect genotypes, mutations, or chromosomal changes.” Under Title I, however, insurers can make coverage decisions based on analyses of proteins and metabolites that are directly related to a pre-existing disease.
The GPPC, Genetic Alliance, and others intend to suggest the government give examples of what types of genetic information are protected by the law. For instance, protected under the law’s definition of a “genetic test” are assays that detect genetic mutations for Huntington’s disease; the BRCA1/BRCA2 genes associated with breast and ovarian cancers; HNPCC mutations for colon cancer; pharmacogenetic tests to detect genotypes or mutations associated with drug response; and in utero screens for genetic and chromosomal disorders.
However, complete blood counts that do not detect genotypes, mutations, or chromosomal changes; cholesterol tests; and HIV tests do not meet the definition of protected genetic analyses.

GINA “should specify that a genetic test result is not, by itself, enough to diagnose a manifest [existing] disease.”

In its comments, the Genetic Alliance and other groups plan to point out that GINA “should specify that a genetic test result is not, by itself, enough to diagnose a manifest [existing] disease. If it were, any genetic test result could be declared a ‘diagnosis’ of future disease that has not actually manifested itself in a detectable way — gutting the protections afforded by GINA and undermining Congressional intent.”
Furthermore, the groups plan to say that since GINA does not prevent discrimination based on an existing disease, the law should include mechanisms to ensure that health insurers do not base their coverage decisions on genetic information. Rather, they should base their decisions on information such as existing diseases or claims history, which are not prohibited under the law.
In its comments, Genetic Alliance points out that while an individual with existing breast cancer can be denied health insurance, a family history of breast cancer, which may constitute genetic information about a person, must not be used for underwriting purposes.
Furthermore, the policy groups plan to argue that a payor cannot alter a covered individual’s insurance based on genetic predisposition data. For instance, while a payor may increase a woman’s insurance premiums if she develops breast cancer, it cannot raise her rates if results of a BRCA test suggest she is at increased risk of ovarian cancer.  
Another issue the policy centers plan to raise is the potential for GINA to conflict with predecessor health-privacy regulations. For instance, an exemption in the Health Insurance Portability and Accountability Act allows insurers to base underwriting decisions on medical information.
“In drafting regulations to implement the prohibition on collection of genetic information for underwriting purposes, the [Departments of Treasury, Labor, and Health and Human Services] should … ensure that GINA and HIPAA privacy rules governing underwriting are consistent,” the Genetic Alliance and other groups plan to note. “Although the use of protected healthcare information for underwriting purposes may be permitted under HIPAA privacy rules, the use of genetic information for underwriting is prohibited under GINA.”
Implementation Plans
GINA empowers HHS and the labor department to ensure that states enforce health insurance companies to follow its requirements. For instance, GINA authorizes the labor department to enforce the law as it pertains to group health plans and health insurance issuers, and can refer group health plan violations to the Internal Revenue Service. The IRS can then levy an excise tax on group health plans that violate GINA.
“No state health insurance laws today are fully in compliance with GINA requirements,” the GPPC, GHPI, and NWI plan to state in their comments. “In particular, no state law definitions of genetic information completely conform to the federal law definition.
“No states currently have adopted GINA’s definition of genetic test,” the groups plan to argue. “Many do not include family history in the definition of genetic information. No state definitions specifically reference genetic services. In addition, not all states provide for as comprehensive protection against health insurance discrimination based on genetic information.”
In order to conform to GINA, all 50 states will need to revise their definition of “genetic test” and explicitly prohibit insurers from requiring individuals to take genetic tests. In addition, several states will need to add language to laws restricting how and for what purposes genetic information may be collected.
Another issue that will be raised in public comments is the need for mechanisms enabling individuals to file complaints about health insurers violating Title I and the failure of state governments to enforce the alleged violators. GPPC suggests HHS facilitate ways for people to file telephone complaints through a toll-free number, written complaints, and complaints filed via an Internet site; outline plans to maintain regular communication with state officials; describe plans for periodic review of state health-insurance laws and regulations; and develop guidance for states on what constitutes “substantial” enforcement. 
The law requires HHS to “substantially” enforce requirements under GINA in states with regard to health insurance company practices. However, defining what constitutes “substantial” enforcement will be necessary.
“For example, substantial enforcement of GINA rules on collection of genetic information should include forms reviews by state regulators to ensure that insurance policy applications do not ask overly broad questions that would regularly lead to the incidental collection of genetic information,” the GPPC, GHPI, and NWI intends to state in their comments. “In addition, State market conduct examinations should include review of medical underwriting manuals and rating policies and procedures to ensure that insurers are not using genetic information inappropriately.”
The federal government should also outline the circumstances under which the labor department can penalize health insurers that violate GINA, the groups will say. And like HHS, the labor department must describe how it plans to receive complaints; periodically review state health plans; and cooperate with state insurance regulators to gather the necessary data.

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