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PUBLIC LAW 110–233—MAY 21, 2008 122 STAT. 881
Public Law 110– 110th Congress An Act
To prohibit discrimination on the basis of genetic information with respect to health insurance and employment.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) SHORT TITLE.—This Act may be cited as the ‘‘Genetic Information Nondiscrimination Act of 2008’’. (b) TABLE OF CONTENTS.—The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents. Sec. 2. Findings. TITLE I—GENETIC NONDISCRIMINATION IN HEALTH INSURANCE Sec. 101. Amendments to Employee Retirement Income Security Act of 1974. Sec. 102. Amendments to the Public Health Service Act. Sec. 103. Amendments to the Internal Revenue Code of 1986. Sec. 104. Amendments to title XVIII of the Social Security Act relating to medigap. Sec. 105. Privacy and confidentiality. Sec. 106. Assuring coordination. TITLE II—PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION Sec. 201. Definitions. Sec. 202. Employer practices. Sec. 203. Employment agency practices. Sec. 204. Labor organization practices. Sec. 205. Training programs. Sec. 206. Confidentiality of genetic information. Sec. 207. Remedies and enforcement. Sec. 208. Disparate impact. Sec. 209. Construction. Sec. 210. Medical information that is not genetic information. Sec. 211. Regulations. Sec. 212. Authorization of appropriations. Sec. 213. Effective date. TITLE III—MISCELLANEOUS PROVISIONS Sec. 301. Severability. Sec. 302. Child labor protections. SEC. 2. FINDINGS. Congress makes the following findings: (1) Deciphering the sequence of the human genome and other advances in genetics open major new opportunities for medical progress. New knowledge about the genetic basis of illness will allow for earlier detection of illnesses, often before symptoms have begun. Genetic testing can allow individuals to take steps to reduce the likelihood that they will contract
42 USC 2000ff note.
Genetic Information Non- discrimination Act of 2008. 42 USC 2000ff note.
May 21, 2008 [H.R. 493]
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122 STAT. 882 PUBLIC LAW 110–233—MAY 21, 2008
a particular disorder. New knowledge about genetics may allow for the development of better therapies that are more effective against disease or have fewer side effects than current treat- ments. These advances give rise to the potential misuse of genetic information to discriminate in health insurance and employment. (2) The early science of genetics became the basis of State laws that provided for the sterilization of persons having pre- sumed genetic ‘‘defects’’ such as mental retardation, mental disease, epilepsy, blindness, and hearing loss, among other conditions. The first sterilization law was enacted in the State of Indiana in 1907. By 1981, a majority of States adopted sterilization laws to ‘‘correct’’ apparent genetic traits or ten- dencies. Many of these State laws have since been repealed, and many have been modified to include essential constitutional requirements of due process and equal protection. However, the current explosion in the science of genetics, and the history of sterilization laws by the States based on early genetic science, compels Congressional action in this area. (3) Although genes are facially neutral markers, many genetic conditions and disorders are associated with particular racial and ethnic groups and gender. Because some genetic traits are most prevalent in particular groups, members of a particular group may be stigmatized or discriminated against as a result of that genetic information. This form of discrimina- tion was evident in the 1970s, which saw the advent of pro- grams to screen and identify carriers of sickle cell anemia, a disease which afflicts African-Americans. Once again, State legislatures began to enact discriminatory laws in the area, and in the early 1970s began mandating genetic screening of all African Americans for sickle cell anemia, leading to discrimination and unnecessary fear. To alleviate some of this stigma, Congress in 1972 passed the National Sickle Cell Anemia Control Act, which withholds Federal funding from States unless sickle cell testing is voluntary. (4) Congress has been informed of examples of genetic discrimination in the workplace. These include the use of pre- employment genetic screening at Lawrence Berkeley Labora- tory, which led to a court decision in favor of the employees in that case Norman-Bloodsaw v. Lawrence Berkeley Labora- tory (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling public interest in relieving the fear of discrimi- nation and in prohibiting its actual practice in employment and health insurance. (5) Federal law addressing genetic discrimination in health insurance and employment is incomplete in both the scope and depth of its protections. Moreover, while many States have enacted some type of genetic non-discrimination law, these laws vary widely with respect to their approach, application, and level of protection. Congress has collected substantial evi- dence that the American public and the medical community find the existing patchwork of State and Federal laws to be confusing and inadequate to protect them from discrimination. Therefore Federal legislation establishing a national and uni- form basic standard is necessary to fully protect the public from discrimination and allay their concerns about the potential
122 STAT. 884 PUBLIC LAW 110–233—MAY 21, 2008
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 bene- ficiary 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 partici- pant 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 enroll- ment 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 condi- tions as the Secretary may by regulation require for activi- ties conducted under this paragraph. ‘‘(d) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.— ‘‘(1) IN GENERAL.—A group health plan, and a health insur- ance 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 connec- tion 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 informa- tion incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation
Notification.
PUBLIC LAW 110–233—MAY 21, 2008 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 ref- erence 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 uti- lizing 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 indi- vidual 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 PARTICIPA- TION 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 indi- vidual. ‘‘(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 chromo- somal changes. ‘‘(B) EXCEPTIONS.—The term ‘genetic test’ does not mean—
PUBLIC LAW 110–233—MAY 21, 2008 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 DISCOV- ERED.—Notwithstanding clauses (i) and (ii) of subpara- graph (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 Sec- retary 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 partici- pant 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 COR- RECTED 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 exer- cising 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 PUBLIC LAW 110–233—MAY 21, 2008
‘‘(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 enact- ment of this Act to carry out the amendments made by this section. (2) EFFECTIVE DATE.—The amendments made by this sec- tion 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.
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 semi- colon 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 subpara- graph (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 dis- order 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 ( 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.—
Applicability.
29 USC 1132 note.
122 STAT. 890 PUBLIC LAW 110–233—MAY 21, 2008
‘‘(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 informa- tion 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 ref- erence 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 uti- lizing 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 indi- vidual 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 PARTICIPA- TION 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 indi- vidual. ‘‘(17) GENETIC TEST.— ‘‘(A) IN GENERAL.—The term ‘genetic test’ means an analysis of human DNA, RNA, chromosomes, proteins, or
PUBLIC LAW 110–233—MAY 21, 2008 122 STAT. 891
metabolites, that detects genotypes, mutations, or chromo- somal 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, inter- preting, 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 exclu- sion 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 para- graph (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; and
Penalties.
PUBLIC LAW 110–233—MAY 21, 2008 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 PRE- MIUM 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 indi- vidual 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 pre- existing 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.—
42 USC 300gg–53.
122 STAT. 894 PUBLIC LAW 110–233—MAY 21, 2008
‘‘(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 Port- ability 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 cov- erage in the individual market may request only the min- imum 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 Regula- tions, 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 enroll- ment 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 pur- poses (as defined in section 2791). ‘‘(2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer offering
Notification.
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(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 indi- vidual market after the date that is 1 year after the date of enactment of this Act.
SEC. 103. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986. (a) NO DISCRIMINATION IN GROUP PREMIUMS BASED ON GENETIC INFORMATION.—Subsection (b) of section 9802 of the Internal Rev- enue Code of 1986 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 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 subpara- graph (A) or in paragraphs (1) and (2) of subsection (d) shall be construed to limit the ability of 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 COLLEC- TION OF GENETIC INFORMATION; APPLICATION TO ALL PLANS.—Sec- tion 9802 of such Code is amended by redesignating subsection (c) as subsection (f) and by inserting after subsection (b) the fol- lowing new subsections: ‘‘(c) GENETIC TESTING.— ‘‘(1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A group health plan may 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 from obtaining and using the results of a genetic test in making a deter- mination regarding payment (as such term is defined for the purposes of applying the regulations promulgated by the 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).
26 USC 9802.
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‘‘(B) LIMITATION.—For purposes of subparagraph (A), a group health plan may request only the minimum amount of information necessary to accomplish the intended pur- pose. ‘‘(4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), 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 Regula- tions, or equivalent Federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research. ‘‘(B) The plan 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 enroll- ment 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 notifies the Secretary in writing that the plan is conducting activities pursuant to the exception provided for under this paragraph, including a description of the activities conducted. ‘‘(E) The plan complies with such other conditions as the Secretary may by regulation require for activities con- ducted under this paragraph. ‘‘(d) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.— ‘‘(1) IN GENERAL.—A group health plan shall not request, require, or purchase genetic information for underwriting pur- poses (as defined in section 9832). ‘‘(2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—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 in connection with such enrollment. ‘‘(3) INCIDENTAL COLLECTION.—If 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 9801 with respect to genetic information, shall apply to group health plans without regard to section 9831(a)(2).’’. (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 ref- erence in this chapter to genetic information concerning an indi- vidual 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
Notification.
PUBLIC LAW 110–233—MAY 21, 2008 122 STAT. 899
‘‘(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 exclu- sion 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) ENFORCEMENT.— (1) IN GENERAL.—Subchapter C of chapter 100 of the Internal Revenue Code of 1986 (relating to general provisions) is amended by adding at the end the following new section:
‘‘SEC. 9834. ENFORCEMENT.
‘‘For the imposition of tax on any failure of a group health plan to meet the requirements of this chapter, see section 4980D.’’. (2) CONFORMING AMENDMENT.—The table of sections for subchapter C of chapter 100 of such Code is amended by adding at the end the following new item:
‘‘Sec. 9834. Enforcement.’’.
(f) REGULATIONS AND EFFECTIVE DATE.— (1) REGULATIONS.—The Secretary of the Treasury shall issue final regulations or other guidance not later than 12 months after the date of the enactment of this Act to carry out the amendments made by this section. (2) EFFECTIVE DATE.—The amendments made by this sec- tion shall apply with respect to group health plans for plan years beginning after the date that is 1 year after the date of the enactment of this Act.
SEC. 104. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING TO MEDIGAP. (a) NONDISCRIMINATION.—Section 1882(s)(2) of the Social Secu- rity Act (42 U.S.C. 1395ss(s)(2)) is amended by adding at the end the following: ‘‘(E) An issuer of a medicare supplemental policy shall not deny or condition the issuance or effectiveness of the policy (including the imposition of any exclusion of benefits under the policy based on a pre-existing condition) and shall not discriminate in the pricing of the policy (including the adjustment of premium rates) of an individual on the basis of the genetic information with respect to such indi- vidual. ‘‘(F) RULE OF CONSTRUCTION.—Nothing in subpara- graph (E) or in subparagraphs (A) or (B) of subsection (x)(2) shall be construed to limit the ability of an issuer of a medicare supplemental policy from, to the extent other- wise permitted under this title— ‘‘(i) denying or conditioning the issuance or effectiveness of the policy or increasing the premium for an employer based on the manifestation of a disease or disorder of an individual who is covered under the policy; or ‘‘(ii) increasing the premium for any policy issued to an individual based on the manifestation of a disease
Applicability.
26 USC 9802 note.
122 STAT. 900 PUBLIC LAW 110–233—MAY 21, 2008
or disorder of an individual who is covered under the policy (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 AND GENETIC INFORMA- TION.— (1) IN GENERAL.—Section 1882 of the Social Security Act (42 U.S.C. 1395ss) is amended by adding at the end the fol- lowing: ‘‘(x) LIMITATIONS ON GENETIC TESTING AND INFORMATION.— ‘‘(1) GENETIC TESTING.— ‘‘(A) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—An issuer of a medicare supplemental policy shall not request or require an individual or a family member of such individual to undergo a genetic test. ‘‘(B) RULE OF CONSTRUCTION.—Subparagraph (A) 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. ‘‘(C) RULE OF CONSTRUCTION REGARDING PAYMENT.— ‘‘(i) IN GENERAL.—Nothing in subparagraph (A) shall be construed to preclude an issuer of a medicare supplemental policy 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 and section 264 of the Health Insurance Portability and Account- ability Act of 1996, as may be revised from time to time) consistent with subsection (s)(2)(E). ‘‘(ii) LIMITATION.—For purposes of clause (i), an issuer of a medicare supplemental policy may request only the minimum amount of information necessary to accomplish the intended purpose. ‘‘(D) RESEARCH EXCEPTION.—Notwithstanding subpara- graph (A), an issuer of a medicare supplemental policy 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: ‘‘(i) 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. ‘‘(ii) 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.
