This title prohibits health plans and issuers from using genetic information to make eligibility, coverage, underwriting[i] or premium-setting decisions about covered individuals,[ii] even if the plan obtained the information prior to the enactment of GINA.[iii] Health plans and issuers generally may not request or require that covered individuals undergo genetic testing or provide genetic information, subject to three primary exceptions.[iv]
The first exception is for purposes of determining the medical appropriateness of covered items and services.[v] Plans may only use the minimum amount of genetic information necessary to make such a determination. The second exception allows plans to request, in writing, that an individual voluntarily provide genetic information for research purposes, if the request explicitly states that non-compliance will not impact the individual’s enrollment, premium or contribution amounts and that no information will be used for underwriting purposes.[vi] The third and final exception is an “incidental collection” exception that applies when the plan obtains genetic information ancillary to the requesting, requiring or purchasing of other information and does not use the genetic information for underwriting purposes.[vii]
This title expands the protections provided by HIPAA by including genetic information within the definition of health information.[viii] Further, the regulation specifies that use or disclosure of genetic information for underwriting purposes is not a permitted use or disclosure,[ix] and any covered entity that makes such a disclosure shall be subject to the standard HIPAA penalty provisions.[x] These penalties include fines up to $250,000 and/or jail time up to 10 years, depending on the circumstances of the violation.[xi]
Penalties are also available for health plans and issuers that commit violations of the provisions of Title I.[xii] These penalties include a fine of $100 per day of the violation with respect to every affected individual. If the plan or issuer is or should have been aware of the violation and does not correct it within 30 days of discovery, the penalty increases to $2,500 per individual and to $15,000 per individual for violations that are not “de minimis.” Medicare supplemental providers that violate this title will be subject to penalties imposed by their respective State programs.[xiii]
[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)).
[xiii] GINA Title I, § 104(d)