AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.

SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.(a) No Discrimination in Group Premiums Based on Genetic Information.—Section 702(b) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182(b)) is amended—(1) in paragraph (2)(A), by inserting before the semicolon the following: “except as provided in paragraph (3)”; and(2) by adding at the end the following:“(3) No group-based discrimination on basis of genetic information.—“(A) In general.—For purposes of this section, a group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, may not adjust premium or contribution amounts for the group covered under such plan on the basis of genetic information.“(B) Rule of construction.—Nothing in subparagraph (A) or in paragraphs (1) and (2) of subsection (d) shall be construed to limit the ability of a health insurance issuer offering health insurance coverage in connection with a group health plan to increase the premium for an employer based on the manifestation of a disease or disorder of an individual who is enrolled in the plan. In such case, the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other group members and to further increase the premium for the employer.”.(b) Limitations on Genetic Testing; Prohibition on Collection of Genetic Information; Application to All Plans.—Section 702 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182) is amended by adding at the end the following:“(c) Genetic Testing.—“(1) Limitation on requesting or requiring genetic testing.—A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, shall not request or require an individual or a family member of such individual to undergo a genetic test.“(2) Rule of construction.—Paragraph (1) shall not be construed to limit the authority of a health care professional who is providing health care services to an individual to request that such individual undergo a genetic test.“(3) Rule of construction regarding payment.—“(A) In general.—Nothing in paragraph (1) shall be construed to preclude a group health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, from obtaining and using the results of a genetic test in making a determination regarding payment (as such term is defined for the purposes of applying the regulations promulgated by the 122 STAT. 884 Secretary of Health and Human Services under part C of title XI of the Social Security Act and section 264 of the Health Insurance Portability and Accountability Act of 1996, as may be revised from time to time) consistent with subsection (a).“(B) Limitation.—For purposes of subparagraph (A), a group health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, may request only the minimum amount of information necessary to accomplish the intended purpose.“(4) Research exception.—Notwithstanding paragraph (1), a group health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, may request, but not require, that a participant or beneficiary undergo a genetic test if each of the following conditions is met:“(A) The request is made, in writing, pursuant to research that complies with part 46 of title 45, Code of Federal Regulations, or equivalent Federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research.“(B) The plan or issuer clearly indicates to each participant or beneficiary, or in the case of a minor child, to the legal guardian of such beneficiary, to whom the request is made that—“(i) compliance with the request is voluntary; and“(ii) non-compliance will have no effect on enrollment status or premium or contribution amounts.“(C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.“(D) The plan or issuer notifies the Secretary in writing that the plan or issuer is conducting activities pursuant to the exception provided for under this paragraph, including a description of the activities conducted.“(E) The plan or issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this paragraph.“(d) Prohibition on Collection of Genetic Information.—“(1) In general.—A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, shall not request, require, or purchase genetic information for underwriting purposes (as defined in section 733).“(2) Prohibition on collection of genetic information prior to enrollment.—A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, shall not request, require, or purchase genetic information with respect to any individual prior to such individual’s enrollment under the plan or coverage in connection with such enrollment.“(3) Incidental collection.—If a group health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation 122 STAT. 885 of paragraph (2) if such request, requirement, or purchase is not in violation of paragraph (1).“(e) Application to All Plans.—The provisions of subsections (a)(1)(F), (b)(3), (c), and (d), and subsection (b)(1) and section 701 with respect to genetic information, shall apply to group health plans and health insurance issuers without regard to section 732(a).”.(c) Application to Genetic Information of a Fetus or Embryo.—Such section is further amended by adding at the end the following:“(f) Genetic Information of a Fetus or Embryo.—Any reference in this part to genetic information concerning an individual or family member of an individual shall—“(1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic information of any fetus carried by such pregnant woman; and“(2) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.”.(d) Definitions.—Section 733(d) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended by adding at the end the following:“(5) Family member.—The term ‘family member’ means, with respect to an individual—“(A) a dependent (as such term is used for purposes of section 701(f)(2)) of such individual, and“(B) any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of such individual or of an individual described in subparagraph (A).“(6) Genetic information.—“(A) In general.—The term ‘genetic information’ means, with respect to any individual, information about—“(i) such individual’s genetic tests,“(ii) the genetic tests of family members of such individual, and“(iii) the manifestation of a disease or disorder in family members of such individual.“(B) Inclusion of genetic services and participation in genetic research.—Such term includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual.“(C) Exclusions.—The term ‘genetic information’ shall not include information about the sex or age of any individual.“(7) Genetic test.—“(A) In general.—The term ‘genetic test’ means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.“(B) Exceptions.—The term ‘genetic test’ does not mean—122 STAT. 886“(i) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or“(ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.“(8) Genetic services.—The term ‘genetic services’ means—“(A) a genetic test;“(B) genetic counseling (including obtaining, interpreting, or assessing genetic information); or“(C) genetic education.“(9) Underwriting purposes.—The term ‘underwriting purposes’ means, with respect to any group health plan, or health insurance coverage offered in connection with a group health plan—“(A) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the plan or coverage;“(B) the computation of premium or contribution amounts under the plan or coverage;“(C) the application of any pre-existing condition exclusion under the plan or coverage; and“(D) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.”.(e) ERISA Enforcement.—Section 502 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1132) is amended—(1) in subsection (a)(6), by striking “(7), or (8)” and inserting “(7), (8), or (9)”;(2) in subsection (b)(3), by striking “The Secretary” and inserting “Except as provided in subsections (c)(9) and (a)(6) (with respect to collecting civil penalties under subsection (c)(9)), the Secretary”; and(3) in subsection (c), by redesignating paragraph (9) as paragraph (10), and by inserting after paragraph (8) the following new paragraph:“(9) Secretarial enforcement authority relating to use of genetic information.—“(A) General rule.—The Secretary may impose a penalty against any plan sponsor of a group health plan, or any health insurance issuer offering health insurance coverage in connection with the plan, for any failure by such sponsor or issuer to meet the requirements of subsection (a)(1)(F), (b)(3), (c), or (d) of section 702 or section 701 or 702(b)(1) with respect to genetic information, in connection with the plan.“(B) Amount.—“(i) In general.—The amount of the penalty imposed by subparagraph (A) shall be $100 for each day in the noncompliance period with respect to each participant or beneficiary to whom such failure relates.“(ii) Noncompliance period.—For purposes of this paragraph, the term ‘noncompliance period’ means, with respect to any failure, the period—122 STAT. 887“(I) beginning on the date such failure first occurs; and“(II) ending on the date the failure is corrected.“(C) Minimum penalties where failure discovered.—Notwithstanding clauses (i) and (ii) of subparagraph (D):“(i) In general.—In the case of 1 or more failures with respect to a participant or beneficiary—“(I) which are not corrected before the date on which the plan receives a notice from the Secretary of such violation; and“(II) which occurred or continued during the period involved;the amount of penalty imposed by subparagraph (A) by reason of such failures with respect to such participant or beneficiary shall not be less than $2,500.“(ii) Higher minimum penalty where violations are more than de minimis.—To the extent violations for which any person is liable under this paragraph for any year are more than de minimis, clause (i) shall be applied by substituting ‘$15,000’ for ‘$2,500’ with respect to such person.“(D) Limitations.—“(i) Penalty not to apply where failure not discovered exercising reasonable diligence.—No penalty shall be imposed by subparagraph (A) on any failure during any period for which it is established to the satisfaction of the Secretary that the person otherwise liable for such penalty did not know, and exercising reasonable diligence would not have known, that such failure existed.“(ii) Penalty not to apply to failures corrected within certain periods.—No penalty shall be imposed by subparagraph (A) on any failure if—“(I) such failure was due to reasonable cause and not to willful neglect; and“(II) such failure is corrected during the 30-day period beginning on the first date the person otherwise liable for such penalty knew, or exercising reasonable diligence would have known, that such failure existed.“(iii) Overall limitation for unintentional failures.—In the case of failures which are due to reasonable cause and not to willful neglect, the penalty imposed by subparagraph (A) for failures shall not exceed the amount equal to the lesser of—“(I) 10 percent of the aggregate amount paid or incurred by the plan sponsor (or predecessor plan sponsor) during the preceding taxable year for group health plans; or“(II) $500,000.“(E) Waiver by secretary.—In the case of a failure which is due to reasonable cause and not to willful neglect, the Secretary may waive part or all of the penalty imposed by subparagraph (A) to the extent that the payment of such penalty would be excessive relative to the failure involved.122 STAT. 888“(F) Definitions.—Terms used in this paragraph which are defined in section 733 shall have the meanings provided such terms in such section.”.(f) Regulations and Effective Date.—(1) Regulations.—The Secretary of Labor shall issue final regulations not later than 12 months after the date of enactment of this Act to carry out the amendments made by this section.(2) Effective date.—The amendments made by this section shall apply with respect to group health plans for plan years beginning after the date that is 1 year after the date of enactment of this Act.