ERISA-This act was passed in 1974 in order to regulate voluntary pensions and health plans provided by employers. This concerns the PKU community because it altered the laws concerning coverage of formula and medical foods under “self-insured” health plans. Ordinarily, regulation of health plans is a right of the state. When group health insurance is sold to an employer by a health insurance company, the insurance company (and     policy) is subject to the laws of that state. However, ERISA reserved for the federal government the power to regulate any health plans provided directly to employees by employers without going through a separate insurance company (so-called “self-insured” plans). This creates the “ERISA pre-emption”: by claiming this right, the federal government removed it from the states’ rights. Since that time, the federal government has passed COBRA and HIPAA, in part to protect insured employees from losing insurability when they lose or change jobs. However, federal laws have done little to regulate the content of employer-provided health care plans.

Efforts within any state to require the coverage of treatment, formula or medical foods apply only to plans under the regulation of that state. As a result of the ERISA pre-emption, this does not include self-insured plans. States have no power over those plans: the federal government has reserved this power, but has not exercised it. Any resolution of this problem would have to be at a federal level.


This act was passed in May 2008 in order to prevent discrimination by health plan providers or employers based on genetic information. Specifically, it prevents these parties from requiring genetic testing, and prohibits determining premiums, eligibility for insurance, or employment based on genetic information. This is good news for PKU advocates. It helps allay public fears of routine testing (fear that “Big Brother” will have, and use, the information against them). It may be a boon to research as well, since such public fears could have dampened enthusiasm for research.

There remain two reservations about GINA. First, we lack assurance that the measure will apply to information obtained before GINA, rather than only to that information obtained from that point onward. Second, the definition of “genetic information” is not very specific. We presume that it will include not only specific gene sequences, but also their manifestations. Otherwise it is easy to imagine an employer saying “We didn’t discriminate based on your gene sequence. We were only acting based on you amino acid levels.” Neither of these issues with GINA appears to have been specifically tested yet, and they may in the future present an opportunity for advocacy.