Michael Levin-Epstein

Health plans have much at stake as Congress moves to lay down the do’s and don’ts about use of info gathered via genetic testing.

Michael Levin-Epstein

Managed care governmental affairs and medical directors have been monitoring federal genetic testing legislation for several years, but now, Hill insiders say, with the unanimous passage of the Genetic Information Nondiscrimination Act of 2005 in February by the Senate, their watch-and-see attitude may need to turn into analyze-and-plan mode.

At the very least, observers caution, medical directors should take a hard look immediately at the way their health plans deal with individual and aggregate patient data.

The measure passed by the Senate prohibits discrimination by health insurers and employers against individuals based on genetic information. Health plans could not require genetic information from applicants, or those of family members, as a condition of enrollment. In addition, the bill mandates that insurers not adjust premiums based on genetic information or require individuals to undergo genetic testing.

Congress has unsuccessfully grappled with genetic testing measures in the last several sessions. In 2003, the Senate unanimously passed almost identical legislation (this year’s version deletes one tax-related provision) that would have prohibited the use of genetic information in health insurance coverage decisions, but the measure stalled in the House.

Public concern

This year’s legislation, however, has created much more of a buzz. With incredible genetic breakthroughs in cardiology and other medical areas seemingly occurring daily, lawmakers have developed a renewed interest in trying to determine how health plans should use genetic information. While no one is in favor of unrestrained, unlimited use of genetic information, of course, it’s a little murky what kinds of limits health plans might be willing to accept.

Let’s start, for example, with the stance of America’s Health Insurance Plans. AHIP’s official position is that genetic information, like all private health information, should be protected and, in fact, HIPAA’s privacy rules already strictly regulate the collection, use, and disclosure of this type of information.

The group points out that there are some very positive aspects to this kind of data. "We believe that genetic information can play an important role in quality improvement activities for early detection and intervention through disease management programs," says the AHIP spokesman, Mohit Ghose.

HIP’s position statement, which Ghose describes as being a consensus of what its members and board think on the issue, details another area that could be compromised by genetic nondiscrimination legislation: wellness and disease management programs. The Senate measure specifically states that individuals may not be required to undergo genetic tests and mandates that health care professionals may provide information and notify individuals about genetic tests as long as such actions are carried out as a part of a bona fide wellness program. However, AHIP asserts, health plans, viewing the legislation in its totality, may still be reluctant to provide access to relevant screening and disease management programs. And, of course, there’s no guaranteed that the final legislation will contain the provision relating to wellness programs.

In fact, the measure, as passed by the Senate, specifically mandates that health care professionals may notify individuals about genetic tests and provide information about tests so long as such actions are carried out as part of a bona fide wellness program. But the bill also specifically states that individuals may not be required to undergo genetic tests.

At press time, it was unclear when the House would take up the Genetic Information Nondiscrimination Act. What’s standing in the way of enacting legislation? A couple of key questions underlie the current discussion this time around. First, has there been a problem with discrimination based on genetic information? Second, is legislation really needed to address these alleged abuses?

"I don’t think there’s been much discrimination based on genetic information," says Gregory Piche, a health law lawyer at Holland & Hart. "But I think there’s a huge potential. It makes reasonable underwriting sense for insurers to consider genetic information so as to anticipate problems that could be predicated and planned for."

The purpose of underwriting, Piche points out, is to accurately predict the costs of coverage in the future, and the genetic predisposition of beneficiaries both individually and collectively are useful factors. The problem arises when the focus shifts from aggregate risk to individual risk: Beneficiaries are punished because their personal genetic makeup increases the risk to insurance companies and increases the cost of insurance coverage to employers.

Caution counseled

But while Piche doesn’t think the current legislation will have much of an effect on health plans in the short term, caution should be the watchword in the long term. Plans will want to "be careful about building a firewall between that [genetic] information on the underwriting side from the medical management side," Piche explains. "The trick is to be able to keep that data separate and prove that you keep it separate."

Many states already have enacted legislation that prohibits discrimination based on genetic information. AHIP says that every state but one prohibits genetic discrimination. Thirty-two states have passed laws governing the use of genetic information, according to the U.S. Chamber of Commerce.

In cases where state laws are stricter than the proposed federal legislation, the state statutes will prevail, according to Piche. Because so many states already address genetic discrimination, many health plans may feel little impact from the federal proposal.

For example, in Massachusetts, which enacted legislation five years ago, Fallon Community Health Plan thinks it will be business as usual if the federal law is enacted. Spokeswoman Christina Sciammacco explains that the state law prohibits health insurers from requiring anyone to take a genetic test or from using the results of genetic testing or genetic information to make underwriting and enrollment decisions (e.g., enrollment, renewal, cancelation, or premium decisions).

"There are also provisions of HIPAA that apply to genetic information, essentially duplicating the state provisions, and as AHIP mentions, limiting the collection, use, and disclosure of genetic information for purposes other than treatment, payment, and health care operations without an individual’s written authorization," she adds.

National standard

After conferring with the plan’s government affairs director, Sciammacco notes that, for the most part, the federal bill appears to prohibit practices that are already prohibited under Massachusetts state law. "It appears that the main goal of the bill’s drafters is to create a comprehensive, uniform standard that would apply to all types of health plans everywhere in the country rather than the current system where things are largely done on a state-by-state basis."

Meanwhile, advocacy groups are continuing to monitor the legislation. Michael Eastman, director of labor law policy for the U.S. Chamber of Commerce, worries about the effect on both health plans and employers. "First, what kind of administrative burdens and costs will be placed on employers," he says, "and what kinds of litigation are we opening ourselves up for? [The current legislation] adds a new layer that is, at times, inconsistent with existing law. It’s incumbent on us and appropriate to first ask where current law is failing us that we need additional legislation."

As Eastman points out, the legislation calls for jury trials and punitive or compensatory damages if the law is breached. The health insurance side of the proposed bill sets forth penalties for violations. There’s a lot at stake, he concludes.

Still unclear

It’s still early in the current congressional session, of course, and at this point, it’s unclear how the several House panels with jurisdiction over the legislation — including the Education, Commerce, and Ways and Means committees — will deal with the issue. In the end, House reaction and response will depend on its sometimes unpredictable leadership.

"I believe this legislation is a product of the unease among the public about the use of genetic information," Piche concludes. "People have seen credit card companies make data available that show your buying proclivities and interests. They just want to be able to continue to work and to buy insurance and not be branded because of a genetic tendency."

Michael Levin-Epstein is a freelance health care writer based in Maryland.

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