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House Passes GINA as Part of Broader Mental-Health Bill, But New Risks Emerge

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The US House of Representatives last week attempted to resuscitate the Genetic Information Nondiscrimination Act after passing the stalled legislation by a 116-vote margin.
 
The bill, which was bundled as an amendment to the Paul Wellstone Mental Health and Addiction Equity Act of 2007 (H.R. 1424), has not changed materially from when it was introduced in the House as a standalone bill, H.R. 493. Still, it is not a guaranteed shoe-in in the Senate, where it heads next, or with President Bush, who had been prepared to sign GINA into law as a standalone bill, if passed by the House and the Senate.
 
Criticisms associated with the mental health bill—that it would increase health coverage costs, distort the prescription drug market, and discourage innovation in drug development—could compel the Bush Administration to veto the mental health bill, scuttling GINA in the process.
 
In a 264–148 vote, the House passed GINA last Wednesday by attaching it to the mental health bill introduced by Rep. Patrick Kennedy (D – RI), which would require health insurance companies to offer benefits for mental health and substance-related disorders under group health plans.
 
Congresswoman Louise Slaughter (D – NY), who sponsored GINA in the House, said in a statement on Wednesday that because “most mental health diseases are genetically linked, GINA is a natural addition” to the Kennedy bill.
 
“Essentially, the House put GINA back in play,” Edward Abrahams, the Personalized Medicine Coalition's executive director, told Pharmacogenomics Reporter last week. But he cautioned that “there are more important differences within the Senate about the mental health parity bill than there are with GINA.”
 
He said this means the senators will likely have to resolve their differences regarding the mental health parity bill and GINA in conference.
 
The move can also be seen as a strategic maneuver on the part of GINA's supporters in the House to circumvent the “hold” placed on the bill by Senator Tom Coburn (R-Okla.), who maintains the bill could permit people to misuse their insurer’s decision to dispute their employer’s job determinations.
 
However, with the passage of the mental health bill in the House last week, a group of 11 senators sent a letter to Democratic leaders in Congress last week raising “important concerns” about the need to reconcile the House and Senate versions of the bill. Additionally, the senators worried about GINA’s ability to “maintain current law distinctions between employee benefit disputes … and disputes about civil rights in the employment context.”
 
However, at this stage, GINA backers are hoping that linking GINA to a larger bill will make it harder for Coburn to muster enough votes to block it. “Coburn has some support, but not enough in the full Senate if the thing ever gets to the floor,” Genetic Alliance CEO Sharon Terry told Pharmacogenomics Reporter this week.
 
Emboldening Blockers?
 
At its core, GINA would prohibit group health plans and health insurers from denying coverage or raising premiums for healthy individuals based solely on a genetic predisposition to developing a disease in the future. The bill would also bar employers from using genetic information to make hiring, firing, job-placement, or promotion decisions.
 
The legislation has languished in Congress since 1995, when it was first introduced. Last year, for the first time, the House passed the bill after 12 years of blocking it from coming to a vote, only to be held up in the Senate by Coburn. [see PGx Reporter 02-21-2007]
 
The “hold” could have been lifted if the Senator dropped his objections to the bill or if the Senate agreed to debate it for 30 hours and pass it with 60 percent of the vote.
 
In the past, HHS Secretary Michael Leavitt has expressed confidence that despite Coburn’s political opposition, the bill would be passed by the current Congress and signed into law by President Bush.
 
However, after the mental health bill passed in the House, it appears now that getting the President’s signature may require some tweaking with regard to GINA.
 

“Coburn has some support, but not enough in the full Senate if the thing ever gets to the floor.”

Following the passage of H.R. 1424, the Bush administration issued a statement stating that while it “strongly supports passage of legislation to prevent the misuse of an individual’s personal genetic information and believes such legislation is critical to realizing the full potential of genomic medicine, the Administration has both substantive and process objections to the rule.”
 
According to the Administration’s statement, the President is “strongly opposed” to the absence of a clear “firewall” separating the two legislative aims of GINA: preventing genetic discrimination by health insurers and by employers.
 
“The bill fails to ensure that health benefits disputes are properly brought under the appropriate remedies in [Employment Retirement Income Security Act], the Public Health Service Act, or the Internal Revenue Code, and that it could unintentionally permit ‘forum shopping,’” the Administration said in its statement.
 
Additionally, “unless the legislation is clarified, the bill could be construed to have the unintended effect of prohibiting health plans and issuers from using information about the manifested disease of a dependent covered under an individual’s plan for appropriate and routine insurance purposes.”
 
The 11 senators who sent a letter to Democratic leaders in Congress last Tuesday expressed concern that the bill would hold employers liable for inadvertently learning of their employers' genetic information.
 
They added: “We believe the final draft of GINA should provide clarity to the health insurance industry, maintain the integrity of the underwriting process, and ensure accurate premium assessments.”
 
Some of GINA's detractors, including the US Chamber of Commerce, the National Association of Manufacturers, and the National Retail Federation, among others, have formed the Genetic Information Non-Discrimination in Employment Coalition.
 
Michael Eastman, executive director of labor policy at the US Chamber of Commerce, told Pharmacogenomics Reporter sister publication GenomeWeb Daily News last week that his group has concerns similar to those expressed by the 11 senators. He remained optimistic, however, that the group may be appeased with “minor technical fixes” to GINA.
 
The US Chamber of Commerce advocates the need for a narrow exception to genetic discrimination, similar to the American Disabilities Act. “If science progresses to the point where it is possible to determine that an individual is virtually certain to have a health condition posing significant risk to others, then employers should be able to make employment decisions based on this information,” the Chamber of Commerce states on its website.
 
Appeasing Coburn
 
Ultimately, in order to appease GINA's detractors, some compromises may have to be made, either to the amendment or to the standalone bill.
 
“It is the same as the House-passed bill,” Terry said. “There are no plans to change it. But there may have to be more negotiations to deal with Coburn’s issues.”
 
Coburn opposes GINA on a number of grounds. Mainly, the senators, in line with the Bush Administration, wants the bill to include a “firewall” separating people’s ability to challenge insurance decisions from their ability to legally dispute their employer’s determinations.
 
Susannah Baruch, a senior policy analyst at the Genetics and Public Policy Center at the Johns Hopkins University Medical Center, told Pharmacogenomics Reporter sister publication GenomeWeb Daily News this week that a compromise is still possible on the stand-alone version of GINA.
 
Baruch said there may have been “an agreement behind the scenes on many of these issues,” and that compromise language may have been agreed upon.
 
“There has been a good faith effort on all parts to work the language out,” Baruch said. “We’re so close to seeing it happen that I’d be surprised if the ‘hold’ held.”
 
The 11 senators who object to GINA also noted in their letter that “a few language changes—fully consistent with the longstanding intent of GINA—will secure its swift Senate passage.”

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