LawyersUSA

Employers, health insurers and their attorneys must start planning now for a new federal law that will force them to protect genetic privacy and prevent discrimination based on genetic information.

While the law – officially dubbed the Genetic Information Non-Discrimination Act – is not expected to unleash a torrent of genetic discrimination suits, it imposes privacy and record-keeping restrictions on employers and insurers, who are accustomed to exchanging health care information freely.

The law is scheduled to go into effect in November 2009, 18 months after it was enacted.

Boston attorney David S. Resnick, who leads the biotech and chemistry practice group at Nixon Peabody, said the law is expected to facilitate:

• 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.

The Act removes "legal hurdles to genetic testing and decoding of the personal genome, paving the way for personalized medicine," said Resnick.

The privacy requirements in the law "appear 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. He noted that Congress only cited one recorded case of alleged genetic discrimination.

The measure restricts who can access genetic information.

"When it comes to genetic information, you should not have it and cannot ask for it under [the new law]," said Michael Rosen, a management lawyer and partner at Foley Hoag in Boston. "There are also firm non-disclosure provisions [for] those who get [genetic information] inadvertently."

Big penalties

Violators will be exposed to penalties of up to $300,000 per offense, as well as punitive damages, attorney fees and administrative remedies, said Gary M. Feldman, a shareholder in Davis, Malm & D'Agostine in Boston.

"The penalties for tripping up are big," said Feldman, who represents employers.

The law also bars health insurers from seeking genetic information, as well as using it to set rates, make coverage decisions or determine eligibility.

A benefit for plaintiffs' lawyers is that they will be able to look through patient files to determine if there was preventive medicine that doctors arguably should have performed based on genetic clues that were overlooked.

"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, a management lawyer who practices with Miller Canfield in Lansing, Mich.

As a result, health care providers might have to utilize available genetic data sooner rather than later to avoid liability for failure to diagnose conditions, provide treatments or avoid prescriptions that harm specific genotypes.

While the law 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."

Training needed

Employers will need to train employees on how to deal with genetic information issues.

"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 recommends that employers consider adding disclaimers to general document requests, particularly for health care records, stating: "Please don't provide any genetic information in response to this request."

Connors suggested that employers "give a letter to all [their] investigators telling them not to seek or provide genetic information."

One of the biggest questions raised by the new law, according to Connors, 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 litigation risks will likely come from §206, a provision of the new law that relates 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 [the law]."

Exemptions and questions

Employers may want to participate in future notice and comment procedures for EEOC rulemaking to clarify the exemptions from liability under the law.

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.

The new law specifically protects employers that receive genetic information while strictly following guidelines under the Family and Medical Leave Act, he said, providing some assurance that 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 covered by a liability exception under the new law.

However, it's unclear whether a program run by an employer is protected by the exception, Belo said, while such a program run by a third party vendor is clearly covered.

To be safe, 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. He also noted that "what happens in the wellness program must stay in the wellness program, or you'll be in trouble."

The Act permits genetic monitoring for those who are testing the effects of toxic substances in the workplace.

It also permits 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.

Questions or comments can be directed to the news editor at: reni.gertner@lawyersusaonline.com