The Genetic Information Nondiscrimination Act (GINA): Public Policy and Medical Practice in the Age of Personalized Medicine

Zurück zum Zitat Regulations Under the Genetic Information Nondiscrimination Act of 2008, 75 Fed. Reg. 68912 (2010). Regulations Under the Genetic Information Nondiscrimination Act of 2008, 75 Fed. Reg. 68912 (2010).

Zurück zum Zitat Haga SB, Carrig MM, O'Daniel JM, et al. Genomic risk profiling: attitudes and use in personal and clinical care of primary care physicians who offer risk profiling. J Gen Intern Med. 2011;26:834–40.PubMedCrossRef Haga SB, Carrig MM, O'Daniel JM, et al. Genomic risk profiling: attitudes and use in personal and clinical care of primary care physicians who offer risk profiling. J Gen Intern Med. 2011;26:834–40.PubMedCrossRef

Zurück zum Zitat Hudson KL, Holohan MK, Collins FS. Keeping pace with the times — The Genetic Information Nondiscrimination Act of 2008. N Engl J Med. 2008;358:2661–63.PubMedCrossRef Hudson KL, Holohan MK, Collins FS. Keeping pace with the times — The Genetic Information Nondiscrimination Act of 2008. N Engl J Med. 2008;358:2661–63.PubMedCrossRef

Zurück zum Zitat Protecting Workers from Genetic Discrimination: Hearing Before the Subcommittee on Health, Employment, Labor, and Pensions, Committee on Education and Labor, U.S. House of Representatives, 110th Cong., 1st Sess. 33–35 (2007) (prepared statement of Dean Karen Rothenberg). Protecting Workers from Genetic Discrimination: Hearing Before the Subcommittee on Health, Employment, Labor, and Pensions, Committee on Education and Labor, U.S. House of Representatives, 110^th Cong., 1^st Sess. 33–35 (2007) (prepared statement of Dean Karen Rothenberg).

Zurück zum Zitat S.Rep.No.110-48, 110th Cong., 1st Sess. 6 (2007). S.Rep.No.110-48, 110th Cong., 1st Sess. 6 (2007).

Zurück zum Zitat They appear to have had significant public support. “Besides the more than 200 health advocacy and business organizations that support this bill, recent surveys show 93 percent of Americans believe that employers and insurers should not be able to use genetic information to discriminate.” 153 Cong. Rec. 10310, 10323 (permanent ed. Apr. 25 2007) (statement of Rep. Biggert). They appear to have had significant public support. “Besides the more than 200 health advocacy and business organizations that support this bill, recent surveys show 93 percent of Americans believe that employers and insurers should not be able to use genetic information to discriminate.” 153 Cong. Rec. 10310, 10323 (permanent ed. Apr. 25 2007) (statement of Rep. Biggert).

Zurück zum Zitat Genetic Information Nondiscrimination Act of 2008 , Pub.L. 110–233, 122 Stat. 881 (2008). Genetic Information Nondiscrimination Act of 2008 , Pub.L. 110–233, 122 Stat. 881 (2008).

Zurück zum Zitat Korobkin R, Rajkumar R. The Genetic Information Nondiscrimination Act — A half-step toward risk sharing. N Engl J Med. 2008;359:335–37.PubMedCrossRef Korobkin R, Rajkumar R. The Genetic Information Nondiscrimination Act — A half-step toward risk sharing. N Engl J Med. 2008;359:335–37.PubMedCrossRef

Zurück zum Zitat For a European example, see Hoyweghen IV, Horstman K. European practices of genetic information and insurance: Lessons for the Genetic Information Nondiscrimination Act. JAMA. 2008; 300:326–27. For a European example, see Hoyweghen IV, Horstman K. European practices of genetic information and insurance: Lessons for the Genetic Information Nondiscrimination Act. JAMA. 2008; 300:326–27.

Zurück zum Zitat Patient Protection and Affordable Care Act, Pub.L. 111–148, 124 Stat. 119 (2010). Patient Protection and Affordable Care Act, Pub.L. 111–148, 124 Stat. 119 (2010).

Zurück zum Zitat 42 U.S.C.A. §300gg-3(b)(1)(B) (2010) (“Genetic information shall not be treated as a condition described in subsection (a)(1) of this section in the absence of a diagnosis of the condition related to such information”). Like many parts of PPACA, the preexisting condition exclusion is undergoing legal review. 42 U.S.C.A. §300gg-3(b)(1)(B) (2010) (“Genetic information shall not be treated as a condition described in subsection (a)(1) of this section in the absence of a diagnosis of the condition related to such information”). Like many parts of PPACA, the preexisting condition exclusion is undergoing legal review.

Zurück zum Zitat Roberts JL. Preempting discrimination: lessons from the Genetic Information Nondiscrimination Act. Vanderbilt Law Rev. 2010;63:439–90. Roberts JL. Preempting discrimination: lessons from the Genetic Information Nondiscrimination Act. Vanderbilt Law Rev. 2010;63:439–90.

Zurück zum Zitat This view is strongly stated by Senator Kennedy in S.Rep.No.110-48, 110th Cong., 1st Sess. 7 (2007): “Although surveys and polls demonstrate a fairly widespread fear of discrimination, there is little evidence or documentation of actual discrimination in health insurance.” This view is strongly stated by Senator Kennedy in S.Rep.No.110-48, 110th Cong., 1st Sess. 7 (2007): “Although surveys and polls demonstrate a fairly widespread fear of discrimination, there is little evidence or documentation of actual discrimination in health insurance.”

Zurück zum Zitat Kaufmann MB. Genetic discrimination in the workplace: an overview of existing protections. Loyola Univ Chicago Law J. 1999;30(393–438):402–03. Kaufmann MB. Genetic discrimination in the workplace: an overview of existing protections. Loyola Univ Chicago Law J. 1999;30(393–438):402–03.

Zurück zum Zitat Ibid. Ibid.

Zurück zum Zitat The Genetic Information Nondiscriminiation Act: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, U.S. House of Representatives, 110th Cong., 1st Sess. 33 (2007) (prepared statement of Sharon Terry, Chair, Coalition for Genetic Fairness, and President, Chief Executive Officer, Genetic Alliance, Washington, DC). Id. at 4095. The Genetic Information Nondiscriminiation Act: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, U.S. House of Representatives, 110th Cong., 1st Sess. 33 (2007) (prepared statement of Sharon Terry, Chair, Coalition for Genetic Fairness, and President, Chief Executive Officer, Genetic Alliance, Washington, DC). Id. at 4095.

Zurück zum Zitat S.Rep.No.110-48, 110th Cong., 1st Sess. 6 (2007). S.Rep.No.110-48, 110th Cong., 1st Sess. 6 (2007).

Zurück zum Zitat S.Rep.No.110-48, 110th Cong., 1st Sess. 7 (2007). S.Rep.No.110-48, 110th Cong., 1st Sess. 7 (2007).

Zurück zum Zitat S.Rep.No.110-48, 110th Cong., 1st Sess. 6–8 (2007). According to the report, 63% of respondents to a national telephone survey indicated that they would refuse genetic tests if health insurers or employers could gain access to the results, and 68% of patients answering a questionnaire said that fear of discrimination would keep them from billing their health insurance companies for genetic tests. For similar reasons, the AMA welcomed the passage of GINA, stating that “This new law will allow patients to take advantage of scientific advances in genetics, such as screenings and therapies, without worrying that their personal health information could be used against them by insurers or employers” (statement by Edward Langston, AMA Board Chair: AMA applauds passage of new law to protect patients from genetic discrimination [Internet]. Sussex: UK: Medical News Today; c2011 [posted 2008 May 23; cited 2011 Sep 16]. Available from: 2008 http://www.medicalnewstoday.com/releases/108633.php). It also appears that many people are unaware of the existence of genetic testing (Baer HJ, Brawarsky P, Murray MF, Haas JS. Familial risk of cancer and knowledge and use of genetic testing. J Gen Intern Med. 2010; 25:717–24). S.Rep.No.110-48, 110th Cong., 1st Sess. 6–8 (2007). According to the report, 63% of respondents to a national telephone survey indicated that they would refuse genetic tests if health insurers or employers could gain access to the results, and 68% of patients answering a questionnaire said that fear of discrimination would keep them from billing their health insurance companies for genetic tests. For similar reasons, the AMA welcomed the passage of GINA, stating that “This new law will allow patients to take advantage of scientific advances in genetics, such as screenings and therapies, without worrying that their personal health information could be used against them by insurers or employers” (statement by Edward Langston, AMA Board Chair: AMA applauds passage of new law to protect patients from genetic discrimination [Internet]. Sussex: UK: Medical News Today; c2011 [posted 2008 May 23; cited 2011 Sep 16]. Available from: 2008 http://​www.​medicalnewstoday​.​com/​releases/​108633.​php). It also appears that many people are unaware of the existence of genetic testing (Baer HJ, Brawarsky P, Murray MF, Haas JS. Familial risk of cancer and knowledge and use of genetic testing. J Gen Intern Med. 2010; 25:717–24).

Zurück zum Zitat Genetics and health insurance state anti-discrimination laws [Internet]. Washington: Denver (CO): National Conference of State Legislatures; c2011 [updated 2008 Jan; cited 2011 Sep 16 ]. Available from: http://www.ncsl.org/default.aspx?tabid=14374. Genetic employment laws [Internet]. Washington: Denver (CO): National Conference of State Legislatures; c2011 [updated 2008 Jan; cited 2011 Sep 16]. Available from: http://www.ncsl.org/default.aspx?tabid=14280. Genetics and health insurance state anti-discrimination laws [Internet]. Washington: Denver (CO): National Conference of State Legislatures; c2011 [updated 2008 Jan; cited 2011 Sep 16 ]. Available from: http://​www.​ncsl.​org/​default.​aspx?​tabid=​14374. Genetic employment laws [Internet]. Washington: Denver (CO): National Conference of State Legislatures; c2011 [updated 2008 Jan; cited 2011 Sep 16]. Available from: http://​www.​ncsl.​org/​default.​aspx?​tabid=​14280.

Zurück zum Zitat See Bullock v. Spherion, No. 3:10-cv-465, 2011 WL 1869933 (W.D.N.C. May 16, 2011); Robinson v. Starplex/CMS Event Security, No. CV-10-723-HU, 2011 WL 1541290 (D. Or. Mar. 15, 2011); Citron v. Niche Media/Ocean Drive Magazine, No. 10-24014-CIV, 2011 WL 381939 (S.D. Fla. Feb. 2, 2011); Benoit v. Pennsylvania Board of Probation and Parole-West Division, No. 094047, 2010 WL 481021 (E.D. Pa. Feb. 9, 2010); Capulong v. Dep’t of Education of Guam, No. 10–00005, 2011 WL 1134986 (D. Guam Mar. 24, 2011); Armes v. CSX Transportation, Inc., No. CCB-11-112, 2011 WL 2471476 (D. Md. June 20, 2011). See Bullock v. Spherion, No. 3:10-cv-465, 2011 WL 1869933 (W.D.N.C. May 16, 2011); Robinson v. Starplex/CMS Event Security, No. CV-10-723-HU, 2011 WL 1541290 (D. Or. Mar. 15, 2011); Citron v. Niche Media/Ocean Drive Magazine, No. 10-24014-CIV, 2011 WL 381939 (S.D. Fla. Feb. 2, 2011); Benoit v. Pennsylvania Board of Probation and Parole-West Division, No. 094047, 2010 WL 481021 (E.D. Pa. Feb. 9, 2010); Capulong v. Dep’t of Education of Guam, No. 10–00005, 2011 WL 1134986 (D. Guam Mar. 24, 2011); Armes v. CSX Transportation, Inc., No. CCB-11-112, 2011 WL 2471476 (D. Md. June 20, 2011).

Zurück zum Zitat Klitzman R. Exclusion of genetic information from the medical record. JAMA. 2010;304:1120–21.PubMedCrossRef Klitzman R. Exclusion of genetic information from the medical record. JAMA. 2010;304:1120–21.PubMedCrossRef

Zurück zum Zitat AMA code of ethics: Opinion 2.135 - insurance companies and genetic information [Internet]. Chicago (IL): American Medical Association; c2011 [updated 1996 June; cited 2011 Sep 16]. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2135.page. AMA code of ethics: Opinion 2.135 - insurance companies and genetic information [Internet]. Chicago (IL): American Medical Association; c2011 [updated 1996 June; cited 2011 Sep 16]. Available at: http://​www.​ama-assn.​org/​ama/​pub/​physician-resources/​medical-ethics/​code-medical-ethics/​opinion2135.​page.

Zurück zum Zitat Ibid. Ibid.

Zurück zum Zitat See, for example: Regulations Under the Genetic Information Nondiscrimination Act of 2008, 75 Fed. Reg. 68912 (2010). See, for example: Regulations Under the Genetic Information Nondiscrimination Act of 2008, 75 Fed. Reg. 68912 (2010).