Congress Inadvertently Legalizes Sharing of Genetic Information Without Patient Consent

Blevins points out, "HIPAA regulations permit data sharing without patient consent in connection with treatment, payment, and oversight of the health-care system ('health-care operations'). Thus, by passing a bill that says HIPAA regulations apply to genetic information, Congress unintentionally legalized the sharing of information among many health-care 'covered entities' without patient permission."

The bill passed the Senate late last month, a year after the House approved its own version. Differences between the two were resolved May 1, and the final bill has been sent to President Bush.

In a letter published in theBaltimore Sun regarding the Senate's vote on the anti-discrimination bill, Janis G. Chester, M.D., president of the American Association of Practicing Psychiatrists, stressed: "...A person's genetic test results, and all of his or her medical data, should not be available to anyone without the patient's consent. One's employer should not even know he or she has had testing done, let alone know the results. The sad fact is that the regulations under the Health Insurance Portability and Accountability Act [HIPAA], which were intended to extend patient privacy as we moved from a paper-based system of medical records to a digital system, are a sham. HIPAA allows the routine release of personal health information without patient consent or knowledge, and even over a patient's objection...."

Amending HIPAA Privacy Regulations Without Public Input

H.R. 493 forbids the "use or disclosure" of genetic information for underwriting purposes by insurers under HIPAA regulations. But the bill fails to give individuals the final say on whether their genetic data can be shared for many other purposes permitted under the HIPAA rule. In fact, it requires the [HHS] Secretary to amend the HIPAA regulations to cover genetic information, so that genetic information "shall" be treated as health information. And the bill says that the revised HIPAA rule "shall be effective upon publication [in the Federal Register], without opportunity for any prior public comment, but may be revised, consistent with this section, after opportunity for public comment." (Emphasis added.) In effect, this means:

    --  HHS must publish a notice in the Federal Register to amend the HIPAA
        regulations without an opportunity for public comment.
    --  Once the amended HIPAA regulations take effect, then the public may
        comment on the revised rule.
    --  At that point, the rule may (or may not) be revised again.
    --  In the meantime, genetic information will be defined legally as
        "health information" under HIPAA regulations, which permit the
        sharing of health information for many purposes without patient consent.

Health Plans Permitted to Obtain Genetic Data for Making Payment Determinations

The bill amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code to "prohibit a group health plan from adjusting premium or contribution amounts for a group on the basis of genetic information." Also, group health plans are prohibited from requesting or requiring individuals or their family members from undergoing genetic testing. However, the legislation says that such prohibition may not "limit the authority of a health care professional to request an individual to undergo a genetic test" or "preclude a group health plan from obtaining and using the results of a genetic test in making a determination regarding payment." In other words, insurers cannot establish insurance rates on the basis of genetics, but they can determine payment amounts on that basis.

Do Exceptions Nullify Genetic Privacy Guarantees?

H.R. 493 also makes it illegal for employers to discriminate based on employees' genetic information. And it supposedly makes it unlawful for employers to acquire employees' genetic information. The bill states, "It shall be an unlawful employment practice for an employer to request, require, or purchase genetic information with respect to an employee or a family member of the employee except..." It then goes on to list six exceptions. For example, an exception to the employer nondiscrimination clause includes: "Where an employer inadvertently requests or requires family medical history of the employee or family member of the employee." (Emphasis added.)

History of Genetic Data Abuse

The legislation includes these findings (among others) regarding abuse of genetic information:

    --  "The early science of genetics became the basis of State laws that
        provided for the sterilization of persons having presumed genetic
        'defects' such as mental retardation, mental disease,
        epilepsy, blindness, and hearing loss, among other conditions. The first
        sterilization law was enacted in the State of Indiana in 1907. By 1981,
        a majority of States adopted sterilization laws to 'correct'
        apparent genetic traits or tendencies. Many of these State laws have
        since been repealed, and many have been modified to include essential
        constitutional requirements of due process and equal protection.
        However, the current explosion in the science of genetics, and the
        history of sterilization laws by the States based on early genetic
        science, compels Congressional action in this area."

    --  "Although genes are facially neutral markers, many genetic
        conditions and disorders are associated with particular racial and
        ethnic groups and gender. Because some genetic traits are most prevalent
        in particular groups, members of a particular group may be stigmatized
        or discriminated against as a result of that genetic information. This
        form of discrimination was evident in the 1970s, which saw the advent of
        programs to screen and identify carriers of sickle cell anemia, a
        disease which afflicts African-Americans. Once again, State legislatures
        began to enact discriminatory laws in [this] area, and in the early
        1970s began mandating genetic screening of all African Americans for
        sickle cell anemia, leading to discrimination and unnecessary fear. To
        alleviate some of this stigma, Congress in 1972 passed the National
        Sickle Cell Anemia Control Act, which withholds Federal funding from
        States unless sickle cell testing is voluntary." (Emphasis added.)

    --  "Congress has been informed of examples of genetic discrimination
        in the workplace. These include the use of pre-employment genetic
        screening at Lawrence Berkeley Laboratory, which led to a court decision
        in favor of the employees in [the] case Norman-Bloodsaw v. Lawrence
        Berkeley Laboratory (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress
        clearly has a compelling public interest in relieving the fear of
        discrimination and in prohibiting its actual practice in employment and
        health insurance."

Consent, Ownership and Genetic-Privacy Rights Still Needed

If Congress and President Bush want to ensure that unethical uses of genetic information are not repeated in years to come, they should pass a law that states clearly:

    --  Genetic testing is voluntary.
    --  Individuals own their genetic information.
    --  Genetic information may not be shared without the individual's
        consent.

"Unfortunately, the recently passed Genetic Information Nondiscrimination Act of 2008 falls short of upholding the ethics of consent, ownership and genetic privacy," Blevins said.

The Institute for Health Freedom (IHF) is aWashington, D.C.-based nonprofit think tank whose mission is to bring the issues of personal health freedom to the forefront of the American health-policy debate. IHF monitors and reports on national policies that affect citizens' freedom to choose their health-care treatments and providers, and to maintain their health privacy--including genetic privacy.

Sources:

    --  "Genetic Information Nondiscrimination Act of 2008." To read
        the complete bill, visit the congressional legislative database and
        search for bill number H.R. 493: http://thomas.loc.gov
    --  "Medical Privacy Still Isn't Protected," Baltimore Sun,
        letter to the editor by Janis G. Chester, president of the American
        Association of Practicing Psychiatrists, May 1, 2008: 
        www.baltimoresun.com/news/opinion/letters/bal-ed.le.letters01m0may01,0,6
        346945.story
    --  "The Final Federal Medical Privacy Rule: The Definitive
        Guide," Institute for Health Freedom, March 6, 2003:
        www.forhealthfreedom.org/Publications/Privacy/Rule.html

SOURCE Institute for Health Freedom

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