AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.(a) Amendments Relating to the Group Market.—(1) No discrimination in group premiums based on genetic information.—Section 2702(b) of the Public Health Service Act (42 U.S.C. 300gg–1(b)) is amended—(A) in paragraph (2)(A), by inserting before the semicolon the following: “except as provided in paragraph (3)”; and(B) 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 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.”.(2) Limitations on genetic testing; prohibition on collection of genetic information; application to all plans.—Section 2702 of the Public Health Service Act (42 U.S.C. 300gg–1) 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.—122 STAT. 889 “(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 Secretary 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 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 2791).“(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.122 STAT. 890“(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 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 2701 with respect to genetic information, shall apply to group health plans and health insurance issuers without regard to section 2721(a).”.(3) 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.”.(4) Definitions.—Section 2791(d) of the Public Health Service Act (42 U.S.C. 300gg–91(d)) is amended by adding at the end the following:“(15) Family member.—The term ‘family member’ means, with respect to any individual—“(A) a dependent (as such term is used for purposes of section 2701(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).“(16) 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.“(17) Genetic test.—“(A) In general.—The term ‘genetic test’ means an analysis of human DNA, RNA, chromosomes, proteins, or 122 STAT. 891 metabolites, that detects genotypes, mutations, or chromosomal changes.“(B) Exceptions.—The term ‘genetic test’ does not mean—“(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.“(18) 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.“(19) 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.”.(5) Remedies and enforcement.—Section 2722(b) of the Public Health Service Act (42 U.S.C. 300gg–22(b)) is amended by adding at the end the following:“(3) Enforcement authority relating to genetic discrimination.—“(A) General rule.—In the cases described in paragraph (1), notwithstanding the provisions of paragraph (2)(C), the succeeding subparagraphs of this paragraph shall apply with respect to an action under this subsection by the Secretary with respect to any failure of a health insurance issuer in connection with a group health plan, to meet the requirements of subsection (a)(1)(F), (b)(3), (c), or (d) of section 2702 or section 2701 or 2702(b)(1) with respect to genetic information in connection with the plan.“(B) Amount.—“(i) In general.—The amount of the penalty imposed under this paragraph 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—“(I) beginning on the date such failure first occurs; and122 STAT. 892“(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 an individual—“(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 individual 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 employer (or predecessor employer) 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.”.(b) Amendment Relating to the Individual Market.—122 STAT. 893 (1) In general.—The first subpart 3 of part B of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–51 et seq.) (relating to other requirements) is amended—(A) by redesignating such subpart as subpart 2; and(B) by adding at the end the following:“SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION.“(a) Prohibition on Genetic Information as a Condition of Eligibility.—“(1) In general.—A health insurance issuer offering health insurance coverage in the individual market may not establish rules for the eligibility (including continued eligibility) of any individual to enroll in individual health insurance coverage based on genetic information.“(2) Rule of construction.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e) shall be construed to preclude a health insurance issuer from establishing rules for eligibility for an individual to enroll in individual health insurance coverage based on the manifestation of a disease or disorder in that individual, or in a family member of such individual where such family member is covered under the policy that covers such individual.“(b) Prohibition on Genetic Information in Setting Premium Rates.—“(1) In general.—A health insurance issuer offering health insurance coverage in the individual market shall not adjust premium or contribution amounts for an individual on the basis of genetic information concerning the individual or a family member of the individual.“(2) Rule of construction.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e) shall be construed to preclude a health insurance issuer from adjusting premium or contribution amounts for an individual on the basis of a manifestation of a disease or disorder in that individual, or in a family member of such individual where such family member is covered under the policy that covers such individual. In such case, the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other individuals covered under the policy issued to such individual and to further increase premiums or contribution amounts.“(c) Prohibition on Genetic Information as Preexisting Condition.—“(1) In general.—A health insurance issuer offering health insurance coverage in the individual market may not, on the basis of genetic information, impose any preexisting condition exclusion (as defined in section 2701(b)(1)(A)) with respect to such coverage.“(2) Rule of construction.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e) shall be construed to preclude a health insurance issuer from imposing any preexisting condition exclusion for an individual with respect to health insurance coverage on the basis of a manifestation of a disease or disorder in that individual.“(d) Genetic Testing.—122 STAT. 894 “(1) Limitation on requesting or requiring genetic testing.—A health insurance issuer offering health insurance coverage in the individual market 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 health insurance issuer offering health insurance coverage in the individual market 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 Secretary 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) and (c).“(B) Limitation.—For purposes of subparagraph (A), a health insurance issuer offering health insurance coverage in the individual market may request only the minimum amount of information necessary to accomplish the intended purpose.“(4) Research exception.—Notwithstanding paragraph (1), a health insurance issuer offering health insurance coverage in the individual market may request, but not require, that an individual or a family member of such individual undergo a genetic test if each of the following conditions is met:“(A) The request is made 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 issuer clearly indicates to each individual, or in the case of a minor child, to the legal guardian of such child, 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 issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to the exception provided for under this paragraph, including a description of the activities conducted.“(E) The issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this paragraph.“(e) Prohibition on Collection of Genetic Information.—“(1) In general.—A health insurance issuer offering health insurance coverage in the individual market shall not request, require, or purchase genetic information for underwriting purposes (as defined in section 2791).“(2) Prohibition on collection of genetic information prior to enrollment.—A health insurance issuer offering 122 STAT. 895 health insurance coverage in the individual market shall not request, require, or purchase genetic information with respect to any individual prior to such individual’s enrollment under the plan in connection with such enrollment.“(3) Incidental collection.—If a health insurance issuer offering health insurance coverage in the individual market 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 of paragraph (2) if such request, requirement, or purchase is not in violation of paragraph (1).“(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.” .(2) Remedies and enforcement.—Section 2761(b) of the Public Health Service Act (42 U.S.C. 300gg–61(b)) is amended to read as follows:“(b) Secretarial Enforcement Authority.—The Secretary shall have the same authority in relation to enforcement of the provisions of this part with respect to issuers of health insurance coverage in the individual market in a State as the Secretary has under section 2722(b)(2), and section 2722(b)(3) with respect to violations of genetic nondiscrimination provisions, in relation to the enforcement of the provisions of part A with respect to issuers of health insurance coverage in the small group market in the State.”.(c) Elimination of Option of Non-Federal Governmental Plans To Be Excepted From Requirements Concerning Genetic Information.—Section 2721(b)(2) of the Public Health Service Act (42 U.S.C. 300gg–21(b)(2)) is amended—(1) in subparagraph (A), by striking “If the plan sponsor” and inserting “Except as provided in subparagraph (D), if the plan sponsor”; and(2) by adding at the end the following:“(D) Election not applicable to requirements concerning genetic information.—The election described in subparagraph (A) shall not be available with respect to the provisions of subsections (a)(1)(F), (b)(3), (c), and (d) of section 2702 and the provisions of sections 2701 and 2702(b) to the extent that such provisions apply to genetic information.”.(d) Regulations and Effective Date.—(1) Regulations.—Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to carry out the amendments made by this section.(2) Effective date.—The amendments made by this section shall apply—122 STAT. 896 (A) with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after the date that is 1 year after the date of enactment of this Act; and(B) with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after the date that is 1 year after the date of enactment of this Act.