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H
the third day of January, two thousand and eight
An Act
AMENDMENT: 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.
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 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 treatments. 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 presumed 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 tendencies. 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 discrimination was evident in the 1970s, which saw the advent of programs 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 Laboratory, which led to a court decision in favor of the employees in that case Norman-Bloodsaw v. Lawrence Berkeley Laboratory (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling public interest in relieving the fear of discrimination 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 evidence 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 uniform basic standard is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.
TITLE I--GENETIC NONDISCRIMINATION IN HEALTH INSURANCE
(a) No Discrimination in Group Premiums Based on Genetic Information- Section 702(b) of the Employee Retirement Income Security Act of 1974 (
(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 (
`(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 resultsof 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 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 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 (
`(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--
`(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 (
(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--
`(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.
`(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.
(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 (
(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 (
`(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 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 undergoa 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 caseof 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 writingthat the plan orissuer is conducting activities pursuant to the exception provided for under this paragraph, including a description of the activities conducted.
`(E) The planor 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.
`(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 applyto group health plans and health insurance issuers without regardto 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 Informationof a Fetus or Embryo- Any reference in this partto 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 whois 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, includegenetic 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. 300 gg-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 termis used for purposesof section 2701(f)(2)) of such individual; and
`(B) any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relativeof 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 testsof family members of such individual, and
`(iii) the manifestation of a disease or disorderin family membersof 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 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 underthe plan or coverage; and
`(D) other activities relatedto the creation, renewal, or replacement of a contractof health insurance or health benefits.'.
(5) REMEDIES AND ENFORCEMENT- Section 2722(b) of the Public Health Service Act (
42 U.S.C. 300 gg-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; 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 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-
(1) IN GENERAL- The first subpart 3 of part B of title XXVII of the Public Health Service Act (
(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-
`(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 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 respectto 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. 300 gg-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. 300 gg-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--
(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.
(a) No Discrimination in Group Premiums Based on Genetic Information- Subsection (b) of section 9802 of the Internal Revenue 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 subparagraph (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 Collection of Genetic Information; Application to All Plans- Section 9802 of such Code is amended by redesignating subsection (c) as subsection (f) and by inserting after subsection (b) the following 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 determination 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).
`(B) LIMITATION- For purposes of subparagraph (A), 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 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 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 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 conducted 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 purposes (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 reference in this chapter 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- Subsection (d) of section 9832 of such Code is amended by adding at the end the following:
`(6) FAMILY MEMBER- The term `family member' means, with respect to any individual--
`(A) a dependent (as such term is used for purposes of section 9801(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).
`(7) 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.
`(8) 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--
`(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.
`(9) 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.
`(10) 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) 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 section 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.
(a) Nondiscrimination- Section 1882(s)(2) of the Social Security Act (
`(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 individual.
`(F) RULE OF CONSTRUCTION- Nothing in subparagraph (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 otherwise 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 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 Information-
(1) IN GENERAL- Section 1882 of the Social Security Act (
`(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 Accountability 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 subparagraph (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.
`(iii) No genetic information collected or acquired under this subparagraph shall be used for underwriting, determination of eligibility to enroll or maintain enrollment status, premium rating, or the creation, renewal, or replacement of a plan, contract, or coverage for health insurance or health benefits.
`(iv) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to the exception provided for under this subparagraph, including a description of the activities conducted.
`(v) The issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this subparagraph.
`(2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION-
`(A) IN GENERAL- An issuer of a medicare supplemental policy shall not request, require, or purchase genetic information for underwriting purposes (as defined in paragraph (3)).
`(B) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT- An issuer of a medicare supplemental policy shall not request, require, or purchase genetic information with respect to any individual prior to such individual's enrollment under the policy in connection with such enrollment.
`(C) INCIDENTAL COLLECTION- If an issuer of a medicare supplemental policy 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 subparagraph (B) if such request, requirement, or purchase is not in violation of subparagraph (A).
`(3) DEFINITIONS- In this subsection:
`(A) FAMILY MEMBER- The term `family member' means with respect to an individual, any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of such individual.
`(B) GENETIC INFORMATION-
`(i) 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) subject to clause (iv), the manifestation of a disease or disorder in family members of such individual.
`(ii) 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.
`(iii) EXCLUSIONS- The term `genetic information' shall not include information about the sex or age of any individual.
`(C) GENETIC TEST-
`(i) IN GENERAL- The term `genetic test' means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.
`(ii) 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.
`(D) GENETIC SERVICES- The term `genetic services' means--
`(i) a genetic test;
`(ii) genetic counseling (including obtaining, interpreting, or assessing genetic information); or
`(iii) genetic education.
`(E) UNDERWRITING PURPOSES- The term `underwriting purposes' means, with respect to a medicare supplemental policy--
`(i) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the policy;
`(ii) the computation of premium or contribution amounts under the policy;
`(iii) the application of any pre-existing condition exclusion under the policy; and
`(iv) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
`(F) ISSUER OF A MEDICARE SUPPLEMENTAL POLICY- The term `issuer of a medicare supplemental policy' includes a third-party administrator or other person acting for or on behalf of such issuer.'.
(2) APPLICATION TO GENETIC INFORMATION OF A FETUS OR EMBRYO- Section 1882(x) of such Act, as added by paragraph (1), is further amended by adding at the end the following:
`(4) GENETIC INFORMATION OF A FETUS OR EMBRYO- Any reference in this section to genetic information concerning an individual or family member of an individual shall--
`(A) 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
`(B) 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.'.
(3) CONFORMING AMENDMENT- Section 1882(o) of the Social Security Act (
42 U.S.C. 1395 ss(o)) is amended by adding at the end the following:`(4) The issuer of the medicare supplemental policy complies with subsection (s)(2)(E) and subsection (x).'.
(c) Effective Date- The amendments made by this section shall apply with respect to an issuer of a medicare supplemental policy for policy years beginning on or after the date that is 1 year after the date of enactment of this Act.
(d) Transition Provisions-
(1) IN GENERAL- If the Secretary of Health and Human Services identifies a State as requiring a change to its statutes or regulations to conform its regulatory program to the changes made by this section, the State regulatory program shall not be considered to be out of compliance with the requirements of section 1882 of the Social Security Act due solely to failure to make such change until the date specified in paragraph (4).
(2) NAIC STANDARDS- If, not later than
(3) SECRETARY STANDARDS- If the NAIC does not make the modifications described in paragraph (2) within the period specified in such paragraph, the Secretary of Health and Human Services shall, not later than
(4) DATE SPECIFIED-
(A) IN GENERAL- Subject to subparagraph (B), the date specified in this paragraph for a State is the earlier of--
(i) the date the State changes its statutes or regulations to conform its regulatory program to the changes made by this section, or
(ii)
(B) ADDITIONAL LEGISLATIVE ACTION REQUIRED- In the case of a State which the Secretary identifies as--
(i) requiring State legislation (other than legislation appropriating funds) to conform its regulatory program to the changes made in this section, but
(ii) having a legislature which is not scheduled to meet in 200
(a) In General- Part C of title XI of the Social Security Act is amended by adding at the end the following new section:
`APPLICATION OF HIPAA REGULATIONS TO GENETIC INFORMATION
`Sec. 1180. (a) In General- The Secretary shall revise the HIPAA privacy regulation (as defined in subsection (b)) so it is consistent with the following:
`(1) Genetic information shall be treated as health information described in section 1171(4)(B).
`(2) The use or disclosure by a covered entity that is a group health plan, health insurance issuer that issues health insurance coverage, or issuer of a medicare supplemental policy of protected health information that is genetic information about an individual for underwriting purposes under the group health plan, health insurance coverage, or medicare supplemental policy shall not be a permitted use or disclosure.
`(b) Definitions- For purposes of this section:
`(1) GENETIC INFORMATION; GENETIC TEST; FAMILY MEMBER- The terms `genetic information', `genetic test', and `family member' have the meanings given such terms in section 2791 of the Public Health Service Act (
42 U.S.C. 300 gg-91), as amended by the Genetic Information Nondiscrimination Act of 2007.`(2) GROUP HEALTH PLAN; HEALTH INSURANCE COVERAGE; MEDICARE SUPPLEMENTAL POLICY- The terms `group health plan' and `health insurance coverage' have the meanings given such terms under section 2791 of the Public Health Service Act (
42 U.S.C. 300 gg-91), and the term `medicare supplemental policy' has the meaning given such term in section 1882(g).`(3) HIPAA PRIVACY REGULATION- The term `HIPAA privacy regulation' means the regulations promulgated by the Secretary under this part and section 264 of the Health Insurance Portability and Accountability Act of 1996 (
42 U.S.C. 1320 d-2 note).`(4) UNDERWRITING PURPOSES- The term `underwriting purposes' means, with respect to a group health plan, health insurance coverage, or a medicare supplemental policy--
`(A) rules for, or determination of, eligibility (including enrollment and continued eligibility) for, or determination of, benefits under the plan, coverage, or policy;
`(B) the computation of premium or contribution amounts under the plan, coverage, or policy;
`(C) the application of any pre-existing condition exclusion under the plan, coverage, or policy; and
`(D) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
`(c) Procedure- The revisions under subsection (a) shall be made by notice in the Federal Register published not later than 60 days after the date of the enactment of this section and shall be effective upon publication, without opportunity for any prior public comment, but may be revised, consistent with this section, after opportunity for public comment.
`(d) Enforcement- In addition to any other sanctions or remedies that may be available under law, a covered entity that is a group health plan, health insurance issuer, or issuer of a medicare supplemental policy and that violates the HIPAA privacy regulation (as revisedunder subsection (a) or otherwise) with respect to the use or disclosure of genetic information shall be subject to the penalties described in sections 1176 and 1177 in the same manner and to the same extent that such penaltiesapply to violations of this part.'.
(b) Regulations; Effective Date-
(1) REGULATIONS- Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to carry out the revision required by section 1180(a) of the Social Security Act, as added by subsection (a). The Secretary has the sole authority to promulgate such regulations, but shall promulgate such regulations in consultation with the Secretaries of Labor and the Treasury.
(2) EFFECTIVE DATE- The amendment made by subsection (a) shall take effecton the date that is 1 year after the date of the enactment of this Act.
Except as provided in section 105(b)(1), the Secretary of Health and Human Services, the Secretary of Labor,and the Secretary of the Treasury shall ensure, through the execution of an interagency memorandum of understanding among such Secretaries, that--
(1) regulations, rulings, and interpretations issued by such Secretaries relating to the same matter over which two or more such Secretaries have responsibility under this title (and the amendments made by this title) are administered so as to have the same effect at all times; and
(2) coordination of policies relating to enforcing the same requirements through such Secretaries in order to have a coordinated enforcement strategy that avoids duplication of enforcement efforts and assigns priorities in enforcement.
TITLE II--PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION
In this title:
(1) COMMISSION- The term `Commission' means the Equal Employment Opportunity Commission as created by section 705 of the Civil Rights Act of 1964 (
(2) EMPLOYEE; EMPLOYER; EMPLOYMENT AGENCY; LABOR ORGANIZATION; MEMBER-
(A) IN GENERAL- The term `employee' means--
(i) an employee (including an applicant), as defined in section 701(f) of the Civil Rights Act of 1964 (
(ii) a State employee (including an applicant) described in section 304(a) of the Government Employee Rights Act of 1991 (
(iii) a covered employee (including an applicant), as defined in section 101 of the Congressional Accountability Act of 1995 (
(iv) a covered employee (including an applicant), as defined in section 411(c) of title 3, United States Code; or
(v) an employee or applicant to which section 717(a) of the Civil Rights Act of 1964 (
(B) EMPLOYER- The term `employer' means--
(i) an employer (as defined in section 701(b) of the Civil Rights Act of 1964 (
(ii) an entity employing a State employee described in section 304(a) of the Government Employee Rights Act of 1991;
(iii) an employing office, as defined in section 101 of the Congressional Accountability Act of 1995;
(iv) an employing office, as defined in section 411(c) of title 3, United States Code; or
(v) an entity to which section 717(a) of the Civil Rights Act of 1964 applies.
(C) EMPLOYMENT AGENCY; LABOR ORGANIZATION- The terms `employment agency' and `labor organization' have the meanings given the terms in section 701 of the Civil Rights Act of 1964 (
(D) MEMBER- The term `member', with respect to a labor organization, includes an applicant for membership in a labor organization.
(3) 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 the Employee Retirement Income Security Act of 1974) 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).
(4) 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.
(5) GENETIC MONITORING- The term `genetic monitoring' means the periodic examination of employees to evaluate acquired modifications to their genetic material, such as chromosomal damage or evidence of increased occurrence of mutations, that may have developed in the course of employment due to exposure to toxic substances in the workplace, in order to identify, evaluate, and respond to the effects of or control adverse environmental exposures in the workplace.
(6) 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.
(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 an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes.
(a) Discrimination Based on Genetic Information- It shall be an unlawful employment practice for an employer--
(1) to fail or refuse to hire, or to discharge, any employee, or otherwise to discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment of the employee, because of genetic information with respect to the employee; or
(2) to limit, segregate, or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee, because of genetic information with respect to the employee.
(b) Acquisition of Genetic Information- It shall be an unlawful employment practice for an employer to request, require, or purchase genetic information with respect to an employee or a family member of the employee except--
(1) where an employer inadvertently requests or requires family medical history of the employee or family member of the employee;
(2) where--
(A) health or genetic services are offered by the employer, including such services offered as part of a wellness program;
(B) the employee provides prior, kn
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Genetic information is collected during torture, so where is this law on usage of the collected information? Where is the other comment?
It is well known that for about 30 years now that American Citizens have had there DNA taken without there consent. What just took place from our Congress and Senators was a pardon if you will to protect these people responsible for breaking the law for 30 years. This is a violation of our 4th amendment rights. One again this 110th Congress and Senate gives another bunch of crooks a break. Here is one scary thing they could use our DNA for Framing us on a crime we did not do. This bill needs to be gone over and cover all of our rights to privacy so it is not used or abused against us. They can also use our DNA to make specific viruses that can only affect people with a certain trait. This may also be use as a form of genocide as genetic elimination in the future. I can not believe I am the only one that is out raged people get off the fluoride, we are being so dumbed down. Redo this bill. I will be writing my Representatives next.
I'm sorry, but are you people braindead? Genetic information collected during torture??? Use DNA for framing us on crimes??? Where did THIS come from? Read the bill again! It specifically protects workers from having their family's medical history being used against them. This is a civil rights act, not a free pass for genocide, torture, or any other extreme view.
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