A recently enacted federal law will force employers and health carriers to protect genetic privacy and prevent discrimination based on genetic information.
And while the law – officially dubbed the Genetic Information Non-Discrimination Act (GINA) – is not expected to unleash a torrent of genetic discrimination suits, it does impose privacy and record-keeping restrictions on employers and insurers accustomed to exchanging health care information freely.
GINA removes “legal hurdles to genetic testing and decoding of the personal genome, paving the way for personalized medicine,” according to Boston attorney David S. Resnick, whose own doctor had previously advised him not to do genetic testing because of health insurance and employment risk
Resnick, who leads a biotech and chemistry practice group at Nixon Peabody in Boston, highlighted what GINA is expected to facilitate, including:

Diagnostic forecasting and risk assessment based on individual genotypes;

The tailoring of drug development and therapy based on genotypes; and

Enhanced understanding of environmental impacts by genotype.

More than 100 diseases have already been linked to genetic glitches, and researchers expect to identify hundreds more as genetic databases explode due to rapidly sinking costs of decoding personal genomes.
“Some people said this was a law in search of a problem, but it appears to be an attempt to get in front of the curve on discrimination,” said employment lawyer Vladimir P. Belo of Bricker & Eckler in Columbus, Ohio. Belo pointed out that Congress could only cite one recorded case of alleged genetic discrimination.
“When it comes to genetic information, you should not have it and cannot ask for it under [GINA],” said Michael Rosen of Boston’s Foley Hoag. “There are also firm non-disclosure provisions on those who get it inadvertently.”
“The penalties for tripping up are big,” according to Gary M. Feldman of Boston’s Davis, Malm & D’Agostine. Violators are exposed to penalties up to $300,000 per offense, as well as punitive damages, attorneys’ fees and administrative remedies, he noted.
The biggest consequences, however, may come from plaintiffs’ lawyers who are likely to comb through patient files looking for preventive medicine that doctors should have performed based on genetic clues that were overlooked.
“This could be like arguing the government could have connected the dots to prevent the 9/11 catastrophe. When there’s more information out there, it’s just easier for someone to look back and say ‘you should have known,’” said Jim Thelen of Miller Canfield in Lansing, Mich.
While GINA does not take effect until 2009, employers should gear up for compliance now.
“Employers and health insurers will have to work hand-in-glove together, particularly on record requests and privacy issues,” said Gene Connors of Reed Smith in Pittsburgh. “This looks like a nationwide Linus blanket to get people comfortable with genetic testing, [but] it is full of details and there will be questions surrounding the exemptions.”

Discrimination and privacy

Employers will need to train employees on how to deal with genetic information issues based on the forecasts for rapidly growing demands spurred by new legal protections, experts said.
“The law not only prohibits employers, unions and employment agencies from using genetic information to make employment-related decisions, it prohibits them from requesting, requiring or purchasing that information,” said Belo.
For that reason, he recommended that in-house lawyers consider adding disclaimers to general document requests, particularly for health care records, which would state: “Please don’t provide any genetic information in response to this request.”
Connors similarly recommended that “you might want to give a letter to all your investigators telling them not to seek or provide genetic information.”
He added that one of the biggest questions raised by GINA relates to what should be done with genetic information that’s procured either inadvertently or knowingly pursuant to a statutory exception.
“Under this law,” Connors said, “employers are generally well-advised to keep genetic information hermetically sealed in a separate place from all other employment-related information.”
Because employers are almost certain to get inadvertent disclosures, most of the initial GINA litigation risks will likely come from Section 206 relating to confidentiality and genetic privacy, according to Feldman.
“If you don’t take extra steps to keep this information confidential, then the penalties of the statute can be triggered,” he warned.
Thelen added: “A manager visiting a sick employee in the hospital could easily result in an inadvertent disclosure. Employees could benefit from training segments that deal with foreseeable privacy issues related to GINA.”

Exemptions and questions

Companies may want to participate in future notice and comment procedures for EEOC rulemaking to clarify the exemptions from liability under GINA, according to experts.
The exemption for inadvertent disclosures is “very important but very ambiguous,” according to Thelen. He said many casual disclosures about an employee’s family history could constitute genetic information under the law.
GINA specifically protects companies that receive genetic information when strictly following guidelines under the Family Medical Leave Act, he said, providing some assurance liability will not be triggered when an employee requests leave to care for a parent with a hereditary disease. “But there is no such explicit exemption for requests under the [Americans with Disabilities Act],” Thelen warned.
Belo noted that “there is an ADA obligation to engage in an interactive process [of medical dialogue] to learn what a reasonable accommodation might be for a disabled employee.”
Genetic information acquired for a wellness program designed to improve employee health care is also exempt from liability under GINA. However, it’s unclear whether a program run by an employer fits the exception, Belo said, although such a program run by a third party vendor clearly fits the exception.
Possession of any genetic information procured for a beneficial use, such as a personalized wellness program, should be justified by “a prior, knowing and totally voluntary written consent,” recommended Connors, who also emphasized that “what happens in the wellness program must stay in the wellness program, or you’ll be in trouble.”
GINA also exempts genetic monitoring for those who are testing the effects of toxic substances in the workplace.
It also exempts possession of publicly available information, although “you should not purchase it or seek it if you want to play it safe,” Connors said.
A majority of states have passed their own genetic information statutes in recent years, and others are in the process of doing so.
“Some states say you just can’t access genetic information at all, and the federal law does not supersede them,” said Belo.
He added that Congress did draw a bright line for one area of liability: “They specifically disclaimed disparate impact claims for genetic discrimination.”

Health care and insurance

The non-discrimination and privacy provisions of the new law will directly impact health care providers and insurers.
The genetic testing and diagnostic industry is primed for growth because of pent-up demand that was corked by legal concerns, Resnick said.
Noting that many biomarkers have already been linked to adult onset diseases and deadly side effects for drugs administered to certain patients, he predicted GINA “will facilitate the gathering of more beneficial data and better drug therapies tailored to individuals.”
Customer growth for some companies specializing in genetic analysis is likely to explode, he said. Some, such as Navigenics, can already take an individual’s saliva and find biomarkers linked to dozens of genetic predispositions, he added.
Armed with this information, an individual who knows he carries a biomarker for a progressive disease, such as multiple sclerosis, can begin preventive drug therapies to forestall or even block the harmful progression of the disease.
But drug companies and health care providers, who were major proponents of the law, could also be victims of its side effects.
“At some point, patients will be gathering huge amounts of data and taking it to their doctors, but a personal physician can’t possibly know what to do with all of it,” Resnick said. “It could potentially overwhelm the health care system.”
That is why some have predicted that plaintiffs’ lawyers will ultimately push the envelope of personalized medicine by forcing health care providers and drug companies into early adoption of genetic analysis. Doctors will have to use available genetic data to avoid liabilities for failure to diagnose conditions, provide treatments, or avoid prescriptions that harm specific genotypes.
Feldman said, however, that doctors who have long feared the adverse consequences of obtaining genetic information will be pleased with GINA’s privacy protections, noting that many physicians are currently under obligations to provide all patient information to health insurers. “The really big fear behind this law is about what insurers would do with this information,” he said.
GINA prevents health care insurers not only from seeking genetic information, but using it to set rates, make coverage decisions or determine eligibility. As of now, the law is silent as to life or disability insurers, but experts warned state laws and future federal regulations could change that.
“The insurers will definitely be on the front lines of risk with genetic privacy issues,” said Thelen. “There will probably be significant infighting among health care providers, employers and insurers over who is to blame for any inadvertent disclosures.”
Even though such disclosures should not legally result in adverse employment or health insurance decisions, they might affect qualifications for long-term loans, mortgages or other kinds of insurance, according to experts. Moreover, wrongful disclosures will definitely send some plaintiffs scurrying for recoveries under the painful penalty provisions of the statute.