Comment 20 JHU, Georgetown, and NWI Response to Comments 2.20.09

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Response to comments submitted to the Request for Information on the Genetic Information Nondiscrimination Act issued October 10, 2008 by the Departments of Treasury, Labor, and Health and Human Services As part of an ongoing collaboration funded by The Pew Charitable Trusts, the Genetics and Public Policy Center at Johns Hopkins University, the Georgetown Health Policy Institute, and the National Workrights Institute have analyzed the comments submitted to the recent Genetic Information Nondiscrimination Act (GINA) Request for Information (RFI). We submit this additional analysis to address a number of issues raised in others responses to the RFI. 1. Health Risk Assessments, Wellness Programs, and Disease Management Programs Summary: GINA prohibits health insurers from requesting or requiring genetic information, including family history. There is no exception in Title I for wellness programs, health risk assessments (HRAs) used as part of wellness programs, or disease management programs implemented by health insurance issuers for their enrollees. Thus, genetic information including family history may not be collected through HRAs and wellness programs that are part of the employer ‐ sponsored health plan, nor collected by health insurance issuers prior to enrollment. Regulations implementing Title I must specify that programs that are part of or related to the health insurance offered by an employer must comply with Title Is prohibition on the collection or use of genetic information, including family history. HRAs are questionnaires designed to identify preventable health risks on an individual and group level. Typically they cover areas of behavior such as seatbelt use, tobacco use, alcohol use, and frequency of exercise. They also ask about family history of disease and illness. Eighty ‐ three percent of employer ‐ based wellness programs use HRAs; sometimes the program consists exclusively of such an assessment. 1 They have also been used by a health plan prior to enrollment to determine whether an individual should participate in a disease management program targeting behaviors that trigger or worsen a particular condition such as diabetes or heart disease. Regulations should clarify that programs covered by Title I because they are part of or related to the health plan offered by an employer may not include questions about family history on their initial risk assessment questionnaires and may not use family history to make decisions about what benefits or rewards to offer enrollees. Regulators should interpret broadly when determining whether a program is part of or related to an employers health benefit plan. For example, wellness programs that relate directly to the premium contribution required of group

1 Forrester Research, What Consumers do with Health Risk Assessments. Oct. 2007. 1

health plan participants and beneficiaries, or to the benefits or cost sharing available to group health plan participants and beneficiaries, should be considered part of a group health plan. If HRAs are administered by the same health insurance issuers that administer an employers group health plan, the wellness program should be considered part of the group health plan or related to the group health plan and thus clearly reached by Title I of GINA. Regulators should also consider factors such as whether the employees health plan premiums vary based on either participation or health status achievements in the program. In such cases, the wellness program should also be considered part of the group health plan and subject to Title I requirements. Regulations also should specify a process for finding that a wellness program is not related to or part of a group health plan. A wellness program would be considered separate from the group health plan if it is administered separately from that plan and if no information from the wellness program can be shared with the group health plan or its administrators. Many insurers and plans appear to be opposed to making changes to their HRAs and other forms based on the prohibitions of GINA. We urge federal regulators to state clearly that HRAs used in conjunction with a group health plan or related wellness, disease management, or other programs may not include questions about family history or other genetic information once GINA is in effect. We recommend heightened oversight on this topic, including outreach and education to issuers and group plan administrators as well as compliance audits. Regulators should develop  and HRA forms should include  a notice to individuals that they need not and should not provide genetic information in answering any questions on the form. We recommend that if and only if no genetic information is requested on the form and such notice is provided, information that an individual volunteers may be considered incidental information and treated as such. Some comments summarized concerns that will arise under Title II of GINA. Department of Labor (DOL), Internal Revenue Service (IRS), and Department of Health and Human Services (HHS) regulators will need to provide guidance. In particular, these agencies should work closely with the Equal Employment Opportunity Commission (EEOC) to provide guidance on the issues overlapping between Title I and Title II, as these issues relate to wellness programs that impose substantial financial penalties (e.g., higher deductibles) on participants based on results of HRAs. We believe the HIPAA nondiscrimination rules currently permit a great deal of discrimination based on health status and should be revisited by DOL, HHS, and the Department of Treasury. The EEOC should also consider whether wellness programs currently authorized under HIPAA qualify as voluntary wellness programs under federal employment law. However, should current HIPAA nondiscrimination rules stand, GINA regulations should emphasize that GINAs new prohibition on collection and use of genetic information for underwriting purposes supersedes HIPAA nondiscrimination rules. That is, regardless of whether a group health plan may provide different benefits or charge different premiums based on participation in or health status outcomes of wellness programs under current HIPAA nondiscrimination rules, GINA 2

prohibits the collection or use of genetic information for all underwriting activities defined in GINA, including determination of eligibility for benefits; computation of premiums; or other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. Several responses suggested that wellness programs and/or disease management programs fall under the Rule of Construction 102(a)(2), that allows a health care professional providing health care services to an individual to request that the individual take a genetic test (or ask if the individual has a family history of a condition or for other relevant genetic information). Regulations should clarify what constitutes a treatment setting. It is clear that Congress did not intend for a doctor or nurses mere involvement in a wellness program or disease management program to exempt a program under this rule of construction. 2 Thus, a plan representative who happens to be a health care provider and plays a role in a wellness program or disease management program, but has no or a very limited treatment relationship with the individual, does not qualify. However, regulations should clarify that all plans and all plan representatives may inform and educate patients and providers alike about the availability of genetic testing and plan policies for covering such care, so long as no request or requirement is conveyed. We believe the following examples, based on those offered in the RFI responses, are not prohibited by GINA: • A health care provider who is providing health care to an individual may make a recommendation about BRCA testing to a patient. • A health care provider in a staff model HMO where the doctor works for the insurer similarly may request that a patient take a genetic test. He or she is providing health care to the individual. • A health care provider may request that a patient take a pharmacogenetic test before beginning a particular course of treatment. The health care plan may not directly request that the individual take that test, but the plan may inform the individual of a plan policy that they will not pay for the treatment unless the pharmacogenetic test shows that it will be effective. Pharmacogenetic tests usually refer to diagnostic tools designed to help patients avoid therapies with little chance of success, reduce the number of adverse events, and/or determine what drug or what dose will be most effective for a patient. • A health care plan may send all enrollees information about carrier screening. • A health care plan may send targeted enrollees information about genetic testing based on their age, ethnicity, or other indicators that the genetic test is appropriate for them. • A health care plan may identify people with a manifested specific genetic disease and provide information about a Center for Excellence for that disease. 2 See also the RFI response of Congresswoman Louise Slaughter and Judy Biggert, specifying that GINA was intended to prevent insurers and plans and their representatives from contacting patients to request or require them to take a test.