Source: http://www.healthinfolaw.org/federal-law/GINA
Timestamp: 2019-04-25 12:06:40+00:00

Document:
Title I covers health insurance discrimination and makes amendments to the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), the Internal Revenue Code (IRC), the Health Insurance Portability and Accountability Act of 1996 (HIPPA), and the Social Security Act, to keep health insurers from engaging in genetic discrimination. Title I is enforced by the Department of Labor, the Department of Treasury, and the Department of Health and Human Services (HHS).
Title II covers employment protections and is enforced by the Equal Employment Opportunity Commission (EEOC). It keeps companies from using genetic information to make decisions about hiring, firing, promotions etc. It also blocks businesses from requiring genetic testing as a condition of employment.
With regards to health information law, Title I is the most important part of GINA. The update made the HIPPA (specifically the Privacy Rule) clarifies that genetic information is included under the term health information. The final rule was put into effect on March 26, 2013. GINA provides the minimum standards for genetic information protection. If states have laws that require higher levels of protection, the state laws take precedence.
[i] Definition of “underwriting” includes rules for, or determination of, benefits eligibility, the computation of premium or contribution amounts, the application of any preexisting condition exclusion and, other activities related to the creation, renewal or replacement of a health insurance contract. GINA Title I, § 101(d) (amending ERISA, 29 U.S.C. 1191b(d)(9); GINA Title I, § 102(a)(4) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-91(d)(19)); GINA Title I, § 103(d) (amending IRS Code, 26 U.S.C. 9832(d)(10)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(x)(3)(E)); GINA Title I, § 105(a) (amending HIPAA, 42 U.S.C. 1320d-9(b)(1)).
[ii] GINA Title I, § 101(a)(2) (amending ERISA, 29 U.S.C. 1182(b)(3)(A)); GINA Title I, § 102(a)(1) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(b)(3)(A)) (prohibiting group-based discrimination by group health plans). GINA Title I, § 101(b) (amending ERISA, 29 U.S.C. 1182(d)(1), (2)); GINA Title I, § 102(a)(2) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(d)(1), (2)); GINA Title I, § 103(b) (amending IRS Code, 26 U.S.C. 9802(d)(1), (2)); GINA Title I, § 104(b)(1) (amending Social Security Act with respect to medigap, 42 U.S.C.4395(ss)(x)(2)(A), (B)) (prohibiting use of genetic information by group plans for underwriting purposes and prior to enrollment). GINA Title I, § 103(a)(2) (amending IRS Code, 26 U.S.C. 9802(b)(3)(A)) (prohibiting the use of genetic information by group plans in determining premium and contribution amounts). GINA Title I, § 102(b)(1) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300gg-53(a)(1), (b)(1), (c)(1), (e)(1), (2)) (prohibiting use of genetic information by insurers in the individual market in making determinations for eligibility, coverage, preexisting conditions, premium and contribution rates, for underwriting purposes and prior to enrollment). GINA Title I, § 104(a) (amending Social Security Act with respect to medigap, 42 U.S.C. 1395ss(s)(2)(E)) (prohibiting use of genetic information by Medicare Supplemental Policies in making determinations for eligibility, coverage, preexisting condition, premium or contribution rates).
[iii] Department of Labor website, “FAQs on the Genetic Nondiscrimination Information Act”, Question 7 (available at: www.dol.gov/ebsa/faqs/faq-GINA.html).
[iv] GINA Title I, § 101(b) (amending ERISA, 29 U.S.C. 1182(c)(1), (d)(1), (2)); GINA Title I, § 102(a)(2) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(c)(1), (d)(1), (2)); GINA Title I, § 102(b)(1) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300gg-53(d)(1), (e)(1), (2)); GINA Title I, § 103(b) (amending IRS Code, 26 U.S.C. 9802(c)(1), (d)(1), (2)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(x)(1)(A), (2)(A), (B)).
[v] GINA Title I, § 101(b) (amending ERISA, 29 U.S.C. 1182(c)(3)); GINA Title I, § 102(a)(2) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(c)(3)); GINA Title I, § 102(b)(1) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300gg-53(d)(3)); GINA Title I, § 103(b) (amending IRS Code, 26 U.S.C. 9802(c)(3)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(s)(2)(F)).
[vi] GINA Title I, § 101(b) (amending ERISA, 29 U.S.C. 1182(c)(4)); GINA Title I, § 102(a)(2) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(c)(3)); GINA Title I, § 102(b)(1) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300gg-53(d)(4)); GINA Title I, § 103(b) (amending IRS Code, 26 U.S.C. 9802(c)(4)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(x)(1)(D)).
[vii] GINA Title I, § 101(b) (amending ERISA, 29 U.S.C. 1182(d)(3)); GINA Title I, § 102(a)(2) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-1(d)(3)); GINA Title I, § 102(b)(1) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300gg-53(e)(3)); GINA Title I, § 103(b) (amending IRS Code, 26 U.S.C. 9802(d)(3)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(x)(2)(C)).
[viii] GINA Title I, § 105(a) (amending HIPAA, 42 U.S.C. 1320d-9(a)(1)).
[ix] GINA Title I, § 105(a) (amending HIPAA, 42 U.S.C. 1320d-9(a)(2)).
[x] GINA Title I, § 105(a) (amending HIPAA, 42 U.S.C. 1320d-9(d)).
[xi] HIPAA, 42 U.S.C. 1320d-6.
[xii] GINA Title 1, § 101(e) (amending ERISA, 29 U.S.C. 1132(c)(9); GINA Title I, § 102(a)(5) (amending the PHS Act with respect to group markets, 42 U.S.C. 300gg-22(b)(3); GINA Title I, § 102(b)(2) (amending the PHS Act with respect to individual markets, 42 U.S.C. 300GG-61(b)); GINA Title I, § 103(e)(1) (amending the IRS Code, Chapter 100, Subchapter C, Section 9834)).
This title prohibits employers, labor unions, employment agencies, joint labor-management training and apprenticeship programs (“employers”) from discriminating against employees or applicants based on genetic information and from using genetic information in employment decisions. It is generally illegal to acquire genetic information about an employee or applicant, subject to six primary exceptions.
The first exception, similar to the incidental exception available to health plans and issuers is an “inadvertent collection” exception that applies in situations where an employer unintentionally acquires an employee’s genetic information. The second exception covers the acquisition of genetic information in conjunction with the provision of voluntary employer-sponsored health or genetic services. The employer may acquire genetic information in aggregate terms that do not disclose the identity of any individual from such services if participating employees provide prior written authorization. The third exception allows employers to certify an employee’s family medical leave. The fourth exception permits acquisition of genetic information through commercially and publicly available documents, if the employer does not purchase the documents intending to acquire genetic information. The fifth exception applies to monitoring the biological effects of toxic substances in the workplace, where such monitoring is either required by law or is voluntary and consented to by the employee in a prior written authorization. In this circumstance, the employer may acquire genetic information in aggregate terms if the employer provides the employee with written notice of the monitoring, informs the employee of the results and complies with applicable Federal and State genetic monitoring regulations. The sixth and final exception applies to employers that analyze DNA for law enforcement purposes. These employers may acquire genetic information to analyze DNA markers of employees in order to detect sample contamination.
This title also governs the confidentiality of acquired genetic information. This information must be kept confidential and in a medical record separate from the employee’s personnel file. Genetic information may be disclosed to the employee at his written request; to an occupational or health researcher; to comply with the FMLA or equivalent State law; to a government entity investigating compliance with title II; to a public health organization, if the information concerns a contagious disease that presents an imminent threat of serious harm or death and the employee is informed of the disclosure, and pursuant to a court order expressly authorizing disclosure of the information.
The provisions of Title II apply to public and private employers, and the remedies available for violations of this title will be those remedies outlined within the regulations governing each type of employer group. For example, employers in the private sector subject to the enforcement provisions of Title VII of the Civil Rights Act of 1964 who discriminate against employees on the basis of genetic information would face the penalties listed within Title VII, which could include back pay, reinstatement and compensatory damages as high as $300,000 for the largest employers.
 Scope of application found in GINA Title II, § 201(2)(A), 42 U.S.C. 2000ff(2)(A).
 GINA Title II, § 202(a), 42 U.S.C. 2000ff-1(a) (with respect to employers); GINA Title II, § 203(a), 42 U.S.C. 2000ff-2(a) (with respect to employment agencies); GINA Title II, § 204(a), 42 U.S.C. 2000ff-3(a) (with respect to labor organizations); GINA Title II, § 205(a), 42 U.S.C. 2000ff-4(a) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 202(b), 42 U.S.C. 2000ff-1(b) (with respect to employers); GINA Title II, § 203(b), 42 U.S.C. 2000ff-2(b) (with respect to employment agencies); GINA Title II, § 204(b), 42 U.S.C. 2000ff-3(b) (with respect to labor organizations); GINA Title II, § 205(b), 42 U.S.C. 2000ff-4(b) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 202(b)(1), 42 U.S.C. 2000ff-1(b)(1) (with respect to employers); GINA Title II, § 203(b)(1), 42 U.S.C. 2000ff-2(b)(1) (with respect to employment agencies); GINA Title II, § 204(b)(1), 42 U.S.C. 2000ff-3(b)(1) (with respect to labor organizations); GINA Title II, § 205(b)(1), 42 U.S.C. 2000ff-4(b)(1) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 202(b)(2), 42 U.S.C. 2000ff-1(b)(2) (with respect to employers); GINA Title II, § 203(b)(2), 42 U.S.C. 2000ff-2(b)(2) (with respect to employment agencies); GINA Title II, § 204(b)(2), 42 U.S.C. 2000ff-3(b)(2) (with respect to labor organizations); GINA Title II, § 205(b)(2), 42 U.S.C. 2000ff-4(b)(2) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 202(b)(3), 42 U.S.C. 2000ff-1(b)(3) (with respect to employers); GINA Title II, § 203(b)(3), 42 U.S.C. 2000ff-2(b)(3) (with respect to employment agencies); GINA Title II, § 204(b)(3), 42 U.S.C. 2000ff-3(b)(3) (with respect to labor organizations); GINA Title II, § 205(b)(3), 42 U.S.C. 2000ff-4(b)(3) (with respect to joint labor-management training and apprenticeship programs).
 Commercially and publicly available documents include newspapers, magazines, periodicals and books, but does not include medical databases or court records. GINA Title II, § 202(b)(4), 42 U.S.C. 2000ff-1(b)(4) (with respect to employers); GINA Title II, § 203(b)(4), 42 U.S.C. 2000ff-2(b)(4) (with respect to employment agencies); GINA Title II, § 204(b)(4), 42 U.S.C. 2000ff-3(b)(4) (with respect to labor organizations); GINA Title II, § 205(b)(4), 42 U.S.C. 2000ff-4(b)(4) (with respect to joint labor-management training and apprenticeship programs).
 Equal Opportunity Employment Commission website, “Rules Against Acquiring Genetic Information” (available at: www.eeoc.gov/laws/types/genetic.cfm).
 GINA Title II, § 202(b)(5), 42 U.S.C. 2000ff-1(b)(5) (with respect to employers); GINA Title II, § 203(b)(5), 42 U.S.C.2000ff-2(b)(5) (with respect to employment agencies); GINA Title II, § 204(b)(5), 42 U.S.C. 2000ff-3(b)(5) (with respect to labor organizations); GINA Title II, § 205(b)(5), 42 U.S.C. 2000ff-4(b)(5) (with respect to joint labor-management training and apprenticeship programs).
 These employers are forensic laboratories and businesses that analyze DNA for purpose of human remains identification. GINA Title II, § 202(b)(6), 42 U.S.C. 2000ff-1(b)(6) (with respect to employers); GINA Title II, § 205(b)(6), 42 U.S.C. 2000ff-4(b)(6) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 202(b)(6), 42 U.S.C. 2000ff-1(b)(6) (with respect to employers); GINA Title II, § 205(b)(6), 42 U.S.C. 2000ff-4(b)(6) (with respect to joint labor-management training and apprenticeship programs).
 GINA Title II, § 206(a), 42 U.S.C. 2000ff-5(a).
 GINA Title II, § 206(b)(1), 42 U.S.C. 2000ff-5(b)(1).
 GINA Title II, § 206(b)(2), 42 U.S.C. 2000ff-5(b)(2).
 GINA Title II, § 206(b)(5), 42 U.S.C. 2000ff-5(b)(5).
 GINA Title II, § 206(b)(4), 42 U.S.C. 2000ff-5(b)(4).
 GINA Title II, § 206(b)(6), 42 U.S.C. 2000ff-5(b)(6).
 If the employee is unaware of the court order, the employer must inform him of the court order and what information it disclosed. GINA Title II, § 206(b)(3)(B), 42 U.S.C. 2000ff-5(b)(3)(B).
 GINA Title II, § 206(b)(3), 42 U.S.C. 2000ff-5(b)(3).
 GINA Title II, § 207.
 GINA Title II, § 207(a).
 Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e-4 et seq.
1. Genetic Information Nondiscrimination Act of 2008, Pub. L. 110-223, 122 Stat. 881, Title II codified at 42 U.S.C. 2000ff et seq. (2008) (available at http://www.gpo.gov/fdsys/pkg/PLAW-110publ233/pdf/PLAW-110publ233.pdf).
2. Definition of “genetic information” includes family medical history, information from genetic tests and services, requests for/ receipt of genetic services and participation in clinical research that includes genetic services. GINA Title I, § 101(d) (amending ERISA, 29 U.S.C. 1191b(d)(6)-(8)); GINA Title I, § 102(a)(4) (amending PHS Act with respect to group markets, 42 U.S.C. 300gg-91(D)(16) – (18)); GINA Title I, § 103(d) (amending the IRS Code, 26 U.S.C. 9832(d)(7)-(9)); GINA Title I, § 104(b)(1) (amending the Social Security Act with respect to medigap, 42 U.S.C. 1395ss(x)(3)(B)-(D)); GINA Title I, § 105(a) (amending HIPAA, 42 U.S.C. 1320d-9(b)(1)). Genetic information also includes genetic information of a fetus or an embryo used in reproductive technology. GINA Title I, § 101(c) (amending ERISA, 29 U.S.C. 1182(f)); GINA Title I, § 102(a)(3) (amending PHS Act with respect to group markets, 42 U.S.C. 300gg-1(f)); GINA Title I, § 102(b)(1) (amending PHS Act with respect to individual markets, 42 U.S.C. 300gg-s3(f)); GINA Title I, § 103(c) (amending IRS Code, 26 U.S.C. 9802(f)); GINA Title I, § 104(b)(2) (amending Social Security Act with respect to medigap, 42 U.S.C. 1882(x)(4)). It does not include information directly related to a manifested disease, disorder or pathological condition.

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