[House Report 110-28]
[From the U.S. Government Publishing Office]



110th Congress                                             Rept. 110-28
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     Part 3

======================================================================



 
           GENETIC INFORMATION NONDISCRIMINATION ACT OF 2007

                                _______
                                

 March 29, 2007.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 493]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 493) to prohibit discrimination on the basis of 
genetic information with respect to health insurance and 
employment, having considered the same, report favorably 
thereon with an amendment and recommend that the bill as 
amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................    26
Background and Need for Legislation..............................    26
Hearings.........................................................    30
Committee Consideration..........................................    31
Committee Votes..................................................    31
Committee Oversight Findings.....................................    31
Statement of General Performance Goals and Objectives............    31
New Budget Authority, Entitlement Authority, and Tax Expenditures    31
Earmarks and Tax and Tariff Benefits.............................    31
Committee Cost Estimate..........................................    31
Congressional Budget Office Estimate.............................    32
Federal Mandates Statement.......................................    32
Advisory Committee Statement.....................................    32
Constitutional Authority Statement...............................    32
Applicability to Legislative Branch..............................    32
Section-by-Section Analysis of the Legislation...................    32
Changes in Existing Law Made by the Bill, as Reported............    47
Additional Views.................................................    64

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Genetic Information 
Nondiscrimination Act of 2007''.
  (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 title XVIII of the Social Security Act relating 
to medigap.
Sec. 104. Privacy and confidentiality.
Sec. 104A.  Privacy and confidentiality.
Sec. 105. Assuring coordination.
Sec. 106. Relationship to title II with respect to enforcement.
Sec. 107. Regulations; effective date.

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 PROVISION

Sec. 301. Severability.

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 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

SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 
                    1974.

  (a) Prohibition of Health Discrimination on the Basis of Genetic 
Information or Genetic Services.--
          (1) No enrollment restriction for genetic services.--Section 
        702(a)(1)(F) of the Employee Retirement Income Security Act of 
        1974 (29 U.S.C. 1182(a)(1)(F)) is amended by inserting before 
        the period the following: ``(including information about a 
        request for or receipt of genetic services by an individual or 
        family member of such individual)''.
          (2) No discrimination in group premiums based on genetic 
        information.--Section 702(b) of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1182(b)) is amended--
                  (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 discrimination in group premiums based on genetic 
        information.--For purposes of this section, a group health 
        plan, or a health insurance issuer offering group health 
        insurance coverage in connection with a group health plan, 
        shall not adjust premium or contribution amounts for a group on 
        the basis of genetic information concerning an individual in 
        the group or a family member of the individual (including 
        information about a request for or receipt of genetic services 
        by an individual or family member of such individual).''.
  (b) Limitations on Genetic Testing.--Section 702 of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1182) is amended by 
adding at the end the following:
  ``(c) Genetic Testing.--
          ``(1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, or 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.--Nothing in this part shall be 
        construed to--
                  ``(A) limit the authority of a health care 
                professional who is providing health care services with 
                respect to an individual to request that such 
                individual or a family member of such individual 
                undergo a genetic test;
                  ``(B) limit the authority of a health care 
                professional who is employed by or affiliated with a 
                group health plan or a health insurance issuer and who 
                is providing health care services to an individual as 
                part of a bona fide wellness program to notify such 
                individual of the availability of a genetic test or to 
                provide information to such individual regarding such 
                genetic test; or
                  ``(C) authorize or permit a health care professional 
                to require that an individual undergo a genetic test.
  ``(d) Application to All Plans.--The provisions of subsections 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans and health 
insurance issuers without regard to section 732(a).''.
  (c) Remedies and Enforcement.--Section 502 of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1132) is amended by adding at 
the end the following:
  ``(n) Enforcement of Genetic Nondiscrimination Requirements.--
          ``(1) Injunctive relief for irreparable harm.--With respect 
        to any violation of subsection (a)(1)(F), (b)(3), or (c) of 
        section 702, a participant or beneficiary may seek relief under 
        subsection 502(a)(1)(B) prior to the exhaustion of available 
        administrative remedies under section 503 if it is demonstrated 
        to the court, by a preponderance of the evidence, that the 
        exhaustion of such remedies would cause irreparable harm to the 
        health of the participant or beneficiary. Any determinations 
        that already have been made under section 503 in such case, or 
        that are made in such case while an action under this paragraph 
        is pending, shall be given due consideration by the court in 
        any action under this subsection in such case.
          ``(2) Equitable relief for genetic nondiscrimination.--
                  ``(A) Reinstatement of benefits where equitable 
                relief has been awarded.--The recovery of benefits by a 
                participant or beneficiary under a civil action under 
                this section may include an administrative penalty 
                under subparagraph (B) and the retroactive 
                reinstatement of coverage under the plan involved to 
                the date on which the participant or beneficiary was 
                denied eligibility for coverage if--
                          ``(i) the civil action was commenced under 
                        subsection (a)(1)(B); and
                          ``(ii) the denial of coverage on which such 
                        civil action was based constitutes a violation 
                        of subsection (a)(1)(F), (b)(3), or (c) of 
                        section 702.
                  ``(B) Administrative penalty.--
                          ``(i) In general.--An administrator who fails 
                        to comply with the requirements of subsection 
                        (a)(1)(F), (b)(3), or (c) of section 702 with 
                        respect to a participant or beneficiary may, in 
                        an action commenced under subsection (a)(1)(B), 
                        be personally liable in the discretion of the 
                        court, for a penalty in the amount not more 
                        than $100 for each day in the noncompliance 
                        period.
                          ``(ii) Noncompliance period.--For purposes of 
                        clause (i), the term `noncompliance period' 
                        means the period--
                                  ``(I) beginning on the date that a 
                                failure described in clause (i) occurs; 
                                and
                                  ``(II) ending on the date that such 
                                failure is corrected.
                          ``(iii) Payment to participant or 
                        beneficiary.--A penalty collected under this 
                        subparagraph shall be paid to the participant 
                        or beneficiary involved.
          ``(3) Secretarial enforcement authority.--
                  ``(A) General rule.--The Secretary has the authority 
                to impose a penalty on any failure of a group health 
                plan to meet the requirements of subsection (a)(1)(F), 
                (b)(3), or (c) of section 702.
                  ``(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 individual 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 such 
                                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.''.
  (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) the spouse of the individual;
                  ``(B) a dependent child of the individual, including 
                a child who is born to or placed for adoption with the 
                individual; and
                  ``(C) all other individuals related by blood to the 
                individual or the spouse or child described in 
                subparagraph (A) or (B).
          ``(6) Genetic information.--
                  ``(A) In general.--Except as provided in subparagraph 
                (B), the term `genetic information' means information 
                about--
                          ``(i) an individual's genetic tests;
                          ``(ii) the genetic tests of family members of 
                        the individual; or
                          ``(iii) the occurrence of a disease or 
                        disorder in family members of the individual.
                  ``(B) Exclusions.--The term `genetic information' 
                shall not include information about the sex or age of 
                an 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 (such as obtaining, 
                interpreting, or assessing genetic information); or
                  ``(C) genetic education.''.
  (e) Regulations and Effective Date.--
          (1) Regulations.--Not later than 1 year after the date of 
        enactment of this title, the Secretary of Labor shall issue 
        final regulations in an accessible format 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 18 months after the date of 
        enactment of this title.

SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

  (a) Amendments Relating to the Group Market.--
          (1) Prohibition of health discrimination on the basis of 
        genetic information or genetic services.--
                  (A) No enrollment restriction for genetic services.--
                Section 2702(a)(1)(F) of the Public Health Service Act 
                (42 U.S.C. 300gg-1(a)(1)(F)) is amended by inserting 
                before the period the following: ``(including 
                information about a request for or receipt of genetic 
                services by an individual or family member of such 
                individual)''.
                  (B) 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--
                          (i) in paragraph (2)(A), by inserting before 
                        the semicolon the following: ``, except as 
                        provided in paragraph (3)''; and
                          (ii) by adding at the end the following:
          ``(3) No discrimination in group premiums based on genetic 
        information.--For purposes of this section, a group health 
        plan, or a health insurance issuer offering group health 
        insurance coverage in connection with a group health plan, 
        shall not adjust premium or contribution amounts for a group on 
        the basis of genetic information concerning an individual in 
        the group or a family member of the individual (including 
        information about a request for or receipt of genetic services 
        by an individual or family member of such individual).''.
          (2) Limitations on genetic testing.--Section 2702 of the 
        Public Health Service Act (42 U.S.C. 300gg-1) is amended by 
        adding at the end the following:
  ``(c) Genetic Testing.--
          ``(1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, or 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) Certain rules of construction.--Nothing in this part 
        shall be construed to--
                  ``(A) limit the authority of a health care 
                professional who is providing health care services with 
                respect to an individual to request that such 
                individual or a family member of such individual 
                undergo a genetic test;
                  ``(B) limit the authority of a health care 
                professional who is employed by or affiliated with a 
                group health plan or a health insurance issuer and who 
                is providing health care services to an individual as 
                part of a bona fide wellness program to notify such 
                individual of the availability of a genetic test or to 
                provide information to such individual regarding such 
                genetic test; or
                  ``(C) authorize or permit a health care professional 
                to require that an individual undergo a genetic test.
          ``(3) Rule of construction regarding payment.--
                  ``(A) In general.--Subject to subparagraph (B), 
                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 conditioning payment on 
                obtaining the results of a genetic test or informing 
                members of such policies. For purpose of the preceding 
                sentence, the term `payment' includes reimbursement, 
                billing, claims management, claims adjudication, review 
                of health care services with respect to medical 
                necessity, coverage under a health plan, 
                appropriateness of care, or justification of charges, 
                and utilization review (including precertification, 
                prior authorization, concurrent and retrospective 
                review).
                  ``(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.
  ``(d) Application to All Plans.--The provisions of subsections 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans and health 
insurance issuers without regard to section 2721(a).
  ``(e) 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--
          ``(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.''.
          (3) Remedies and enforcement.--Section 2722(b) of the Public 
        Health Service Act (42 U.S.C. 300gg-22(b)) is amended by adding 
        at the end the following:
          ``(3) Enforcement authority relating to genetic 
        discrimination.--
                  ``(A) General rule.--In the cases described in 
                paragraph (1), notwithstanding the provisions of 
                paragraph (2)(C), the following provisions 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), or (c) of section 2702 or section 2701 or 
                2702(b)(1) with respect to genetic information.
                  ``(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 individual 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 such 
                                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.''.
          (4) Definitions.--Section 2791(d) of the Public Health 
        Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at the 
        end the following:
          ``(15) Family member.--The term `family member' means, with 
        respect to any individual--
                  ``(A) a dependent (as such term is used for purposes 
                of section 2701(f)(2)) of such individual; and
                  ``(B) any other individual who is a first-degree, 
                second-degree, third-degree, or fourth-degree relative 
                of such individual or of an individual described in 
                subparagraph (A).
          ``(16) Genetic information.--
                  ``(A) In general.--The term `genetic information' 
                means information about--
                          ``(i) an individual's genetic tests;
                          ``(ii) the genetic tests of family members of 
                        the individual; or
                          ``(iii) the occurrence of a disease or 
                        disorder in family members of the individual.
                  ``(B) Inclusion of genetic services and participation 
                in genetic research.--Such term includes, with respect 
                to any individual, any request for genetic services, 
                receipt of genetic services, or participation in any 
                clinical research, or any other program, 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 
                an 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 (such as obtaining, 
                interpreting, or assessing genetic information); or
                  ``(C) genetic education.''.
  (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 (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.--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 (including information about a request for or receipt of 
genetic services by an individual or family member of such individual).
  ``(b) Prohibition on Genetic Information in Setting Premium Rates.--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 (including information 
about a request for or receipt of genetic services by an individual or 
family member of such individual).
  ``(c) Prohibition on Genetic Information as Preexisting Condition.--A 
health insurance issuer offering health insurance coverage in the 
individual market may not, on the basis of genetic information 
(including information about a request for or receipt of genetic 
services by an individual or family member of such individual), impose 
any preexisting condition exclusion (as defined in section 
2701(b)(1)(A)) with respect to such coverage.
  ``(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) Certain rules of construction.--Nothing in this part 
        shall be construed to--
                  ``(A) limit the authority of a health care 
                professional who is providing health care services with 
                respect to an individual to request that such 
                individual or a family member of such individual 
                undergo a genetic test;
                  ``(B) limit the authority of a health care 
                professional who is employed by or affiliated with a 
                health insurance issuer and who is providing health 
                care services to an individual as part of a bona fide 
                wellness program to notify such individual of the 
                availability of a genetic test or to provide 
                information to such individual regarding such genetic 
                test; or
                  ``(C) authorize or permit a health care professional 
                to require that an individual undergo a genetic test.
          ``(3) Rule of construction regarding payment.--
                  ``(A) In general.--Subject to subparagraph (B), 
                nothing in paragraph (1) shall be construed to preclude 
                a health insurance issuer offering health insurance 
                coverage in the individual market from conditioning 
                payment on obtaining the results of a genetic test or 
                informing members of such policies. For purpose of the 
                preceding sentence, the term `payment' includes 
                reimbursement, billing, claims management, claims 
                adjudication, review of health care services with 
                respect to medical necessity, coverage under a health 
                plan, appropriateness of care, or justification of 
                charges, and utilization review (including 
                precertification, prior authorization, concurrent and 
                retrospective review).
                  ``(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.
  ``(e) 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--
          ``(1) with respect to such an individual or family member of 
        an individual who is a pregnant woman, include genetic 
        information of any fetus carried by such pregnant woman; and
          ``(2) with respect to an individual or family member 
        utilizing an assisted reproductive technology, include genetic 
        information of any embryo legally held by the individual or 
        family member.''.
          (2) Remedies and enforcement.--Section 2761(b) of the Public 
        Health Service Act (42 U.S.C. 300gg-61(b)) is amended to read 
        as follows:
  ``(b) Secretarial Enforcement Authority.--The Secretary shall have 
the same authority in relation to enforcement of the provisions of this 
part with respect to issuers of health insurance coverage in the 
individual market in a State as the Secretary has under section 
2722(b)(2), and section 2722(b)(3) with respect to violations of 
genetic nondiscrimination provisions, in relation to the enforcement of 
the provisions of part A with respect to issuers of health insurance 
coverage in the small group market in the State.''.
  (c) Elimination of Option of Non-Federal Governmental Plans To Be 
Excepted From Requirements Concerning Genetic Information.--Section 
2721(b)(2) of the Public Health Service Act (42 U.S.C. 300gg-21(b)(2)) 
is amended--
          (1) in subparagraph (A), by striking ``If the plan sponsor'' 
        and inserting ``Except as provided in subparagraph (D), if the 
        plan sponsor''; and
          (2) by adding at the end the following:
                  ``(D) Election not applicable to requirements 
                concerning genetic information.--The election described 
                in subparagraph (A) shall not be available with respect 
                to the provisions of subsections (a)(1)(F) and (c) of 
                section 2702 and the provisions of section 2702(b) to 
                the extent that such provisions apply to genetic 
                information (or information about a request for or the 
                receipt of genetic services by an individual or a 
                family member of such individual).''.
  (d) Regulations and Effective Date.--
          (1) Regulations.--Not later than 1 year after the date of 
        enactment of this title, the Secretary of Labor and the 
        Secretary of Health and Human Services (as the case may be) 
        shall issue final regulations in an accessible format 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 18 months after the date of enactment of this 
                title; 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 18 
                months after the date of enactment of this title.

SEC. 103. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING 
                    TO MEDIGAP.

  (a) Nondiscrimination.--
          (1) In general.--Section 1882(s)(2) of the Social Security 
        Act (42 U.S.C. 1395ss(s)(2)) is amended by adding at the end 
        the following:
                  ``(E)(i) An issuer of a medicare supplemental policy 
                shall not deny or condition the issuance or 
                effectiveness of the policy, and shall not discriminate 
                in the pricing of the policy (including the adjustment 
                of premium rates) of an eligible individual on the 
                basis of genetic information concerning the individual 
                (or information about a request for, or the receipt of, 
                genetic services by such individual or family member of 
                such individual).
                  ``(ii) For purposes of clause (i), the terms `family 
                member', `genetic services', and `genetic information' 
                shall have the meanings given such terms in subsection 
                (x).''.
          (2) Effective date.--The amendment made by paragraph (1) 
        shall apply with respect to a policy for policy years beginning 
        after the date that is 18 months after the date of enactment of 
        this Act.
  (b) Limitations on Genetic Testing.--
          (1) In general.--Section 1882 of the Social Security Act (42 
        U.S.C. 1395ss) is amended by adding at the end the following:
  ``(x) Limitations on Genetic Testing.--
          ``(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.--Nothing in this title 
                shall be construed to--
                          ``(i) limit the authority of a health care 
                        professional who is providing health care 
                        services with respect to an individual to 
                        request that such individual or a family member 
                        of such individual undergo a genetic test;
                          ``(ii) limit the authority of a health care 
                        professional who is employed by or affiliated 
                        with an issuer of a medicare supplemental 
                        policy and who is providing health care 
                        services to an individual as part of a bona 
                        fide wellness program to notify such individual 
                        of the availability of a genetic test or to 
                        provide information to such individual 
                        regarding such genetic test; or
                          ``(iii) authorize or permit a health care 
                        professional to require that an individual 
                        undergo a genetic test.
          ``(2) Definitions.--In this subsection:
                  ``(A) Family member.--The term `family member' means 
                with respect to an individual--
                          ``(i) the spouse of the individual;
                          ``(ii) a dependent child of the individual, 
                        including a child who is born to or placed for 
                        adoption with the individual; or
                          ``(iii) any other individuals related by 
                        blood to the individual or to the spouse or 
                        child described in clause (i) or (ii).
                  ``(B) Genetic information.--
                          ``(i) In general.--Except as provided in 
                        clause (ii), the term `genetic information' 
                        means information about--
                                  ``(I) an individual's genetic tests;
                                  ``(II) the genetic tests of family 
                                members of the individual; or
                                  ``(III) the occurrence of a disease 
                                or disorder in family members of the 
                                individual.
                          ``(ii) Exclusions.--The term `genetic 
                        information' shall not include information 
                        about the sex or age of an 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 (such as obtaining, 
                        interpreting, or assessing genetic 
                        information); or
                          ``(iii) genetic education.
                  ``(E) 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) Conforming amendment.--Section 1882(o) of the Social 
        Security Act (42 U.S.C. 1395ss(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).''.
          (3) Effective date.--The amendments made by this subsection 
        shall apply with respect to an issuer of a medicare 
        supplemental policy for policy years beginning on or after the 
        date that is 18 months after the date of enactment of this Act.
  (c) 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 June 30, 2008, the 
        National Association of Insurance Commissioners (in this 
        subsection referred to as the ``NAIC'') modifies its NAIC Model 
        Regulation relating to section 1882 of the Social Security Act 
        (referred to in such section as the 1991 NAIC Model Regulation, 
        as subsequently modified) to conform to the amendments made by 
        this section, such revised regulation incorporating the 
        modifications shall be considered to be the applicable NAIC 
        model regulation (including the revised NAIC model regulation 
        and the 1991 NAIC Model Regulation) for the purposes of such 
        section.
          (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 October 1, 2008, make the 
        modifications described in such paragraph and such revised 
        regulation incorporating the modifications shall be considered 
        to be the appropriate regulation for the purposes of such 
        section.
          (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) October 1, 2008.
                  (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 2008 in a legislative 
                        session in which such legislation may be 
                        considered, the date specified in this 
                        paragraph is the first day of the first 
                        calendar quarter beginning after the close of 
                        the first legislative session of the State 
                        legislature that begins on or after July 1, 
                        2008. For purposes of the previous sentence, in 
                        the case of a State that has a 2-year 
                        legislative session, each year of such session 
                        shall be deemed to be a separate regular 
                        session of the State legislature.

SEC. 104. PRIVACY AND CONFIDENTIALITY.

  (a) Applicability.--Except as provided in subsection (d), the 
provisions of this section shall apply to group health plans and health 
insurance issuers that offers group health insurance coverage in 
connection with a group health plan, without regard to--
          (1) section 732(a) of the Employee Retirement Income Security 
        Act of 1974 (29 U.S.C. 1191a(a));
          (2) section 9831(a)(2) of the Internal Revenue Code of 1986.
  (b) Compliance With Certain Confidentiality Standards With Respect to 
Genetic Information.--
          (1) In general.--The regulations promulgated by the Secretary 
        of Health and Human Services under part C of title XI of the 
        Social Security Act (42 U.S.C. 1320d et seq.) and section 264 
        of the Health Insurance Portability and Accountability Act of 
        1996 (42 U.S.C. 1320d-2 note) shall apply to the use or 
        disclosure of genetic information by a group health plan or by 
        a health insurance issuer that offers group health insurance 
        coverage in connection with a group health plan.
          (2) Prohibition on underwriting and premium rating.--
        Notwithstanding paragraph (1), a group health plan or a health 
        insurance issuer that offers group health insurance coverage in 
        connection with a group health plan shall not use or disclose 
        genetic information (including information about a request for 
        or a receipt of genetic services by an individual or family 
        member of such individual) for purposes of underwriting, 
        determinations of eligibility to enroll, premium rating, or the 
        creation, renewal or replacement of a plan, contract or 
        coverage for health insurance or health benefits.
  (c) Prohibition on Collection of Genetic Information.--
          (1) In general.--A group health plan or a health insurance 
        issuer that offers group health insurance coverage in 
        connection with a group health plan shall not request, require, 
        or purchase genetic information (including information about a 
        request for or a receipt of genetic services by an individual 
        or family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a plan, 
        contract or coverage for health insurance or health benefits.
          (2) Limitation relating to the collection of genetic 
        information prior to enrollment.--A group health plan or a 
        health insurance issuer that offers group health insurance 
        coverage in connection with a group health plan shall not 
        request, require, or purchase genetic information (including 
        information about a request for or a receipt of genetic 
        services by an individual or family member of such individual) 
        concerning a participant, beneficiary, or enrollee prior to the 
        enrollment, and in connection with such enrollment, of such 
        individual under the plan or coverage.
          (3) Incidental collection.--Where a group health plan obtains 
        or a health insurance issuer that offers group health insurance 
        coverage in connection with a group health plan genetic 
        information incidental to the requesting, requiring, or 
        purchasing of other information concerning a participant, 
        beneficiary, or enrollee, such request, requirement, or 
        purchase shall not be considered a violation of this subsection 
        if--
                  (A) such request, requirement, or purchase is not in 
                violation of paragraph (1); and
                  (B) any genetic information (including information 
                about a request for or receipt of genetic services) 
                requested, required, or purchased is not used or 
                disclosed in violation of subsection (b).
  (d) Application of Confidentiality Standards.--The provisions of 
subsections (b) and (c) shall not apply--
          (1) to group health plans or health insurance issuers that 
        are not otherwise covered under the regulations promulgated by 
        the Secretary of Health and Human Services under part C of 
        title XI of the Social Security Act (42 U.S.C. 1320d et seq.) 
        and section 264 of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note); and
          (2) to genetic information that is not considered to be 
        individually-identifiable health information under the 
        regulations promulgated by the Secretary of Health and Human 
        Services under part C of title XI of the Social Security Act 
        (42 U.S.C. 1320d et seq.) and section 264 of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note).
  (e) Enforcement.--A group health plan or a health insurance issuer 
that offers group health insurance coverage in connection with a group 
health plan that violates a provision of this section shall be subject 
to the penalties described in sections 1176 and 1177 of the Social 
Security Act (42 U.S.C. 1320d-5 and 1320d-6) in the same manner and to 
the same extent that such penalties apply to violations of part C of 
title XI of such Act.
  (f) Preemption.--
          (1) In general.--A provision or requirement under this 
        section or a regulation promulgated under this section shall 
        supersede any contrary provision of State law unless such 
        provision of State law imposes requirements, standards, or 
        implementation specifications that are more stringent than the 
        requirements, standards, or implementation specifications 
        imposed under this section or such regulations. No penalty, 
        remedy, or cause of action to enforce such a State law that is 
        more stringent shall be preempted by this section.
          (2) Rule of construction.--Nothing in paragraph (1) shall be 
        construed to establish a penalty, remedy, or cause of action 
        under State law if such penalty, remedy, or cause of action is 
        not otherwise available under such State law.
  (g) Coordination With Privacy Regulations.--The Secretary shall 
implement and administer this section in a manner that is consistent 
with the implementation and administration by the Secretary of the 
regulations promulgated by the Secretary of Health and Human Services 
under part C of title XI of the Social Security Act (42 U.S.C. 1320d et 
seq.) and section 264 of the Health Insurance Portability and 
Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
  (h) Definitions.--In this section:
          (1) Genetic information; genetic services.--The terms 
        ``family member'', ``genetic information'', ``genetic 
        services'', and ``genetic test'' have the meanings given such 
        terms in section 2791 of the Public Health Service Act (42 
        U.S.C. 300gg-91), as amended by this Act.
          (2) Group health plan; health insurance issuer.--The terms 
        ``group health plan'' and ``health insurance issuer'' include 
        only those plans and issuers that are covered under the 
        regulations described in subsection (d)(1).
          (3) Secretary.--The term ``Secretary'' means the Secretary of 
        Health and Human Services.

SEC. 104A. PRIVACY AND CONFIDENTIALITY.

  (a) PHSA Provisions.--
          (1) Group health plans.--
                  (A) In general.--Title XXVII of the Public Health 
                Service Act is amended by inserting after section 2702 
                the following new section:

``SEC. 2703. PRIVACY AND CONFIDENTIAL OF GENETIC INFORMATION.

  ``(a) Compliance With Certain Confidentiality Standards With Respect 
to Genetic Information.--
          ``(1) In general.--The regulations promulgated by the 
        Secretary under part C of title XI of the Social Security Act 
        (42 U.S.C. 1320d et seq.) and section 264 of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note) shall apply to the use or disclosure of genetic 
        information by a group health plan or by an health insurance 
        issuer in connection with health insurance coverage offered in 
        connection with a group health plan.
          ``(2) Prohibition on underwriting and premium rating.--
        Notwithstanding paragraph (1), a group health plan or a health 
        insurance issuer (in connection with health insurance coverage 
        offered in connection with a group health plan) shall not use 
        or disclose genetic information (including information about a 
        request for or a receipt of genetic services by an individual 
        or family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a plan, 
        contract or coverage for health insurance or health benefits.
  ``(b) Prohibition on Collection of Genetic Information.--
          ``(1) In general.--A group health plan or health insurance 
        issuer (in connection with health insurance coverage offered in 
        connection with a group health plan) shall not request, 
        require, or purchase genetic information (including information 
        about a request for or a receipt of genetic services by an 
        individual or family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a plan, 
        contract or coverage for health insurance or health benefits.
          ``(2) Limitation relating to the collection of genetic 
        information prior to enrollment.--A group health plan or health 
        insurance issuer (in connection with health insurance coverage 
        offered in connection with a group health plan) shall not 
        request, require, or purchase genetic information (including 
        information about a request for or a receipt of genetic 
        services by an individual or family member of such individual) 
        concerning a participant, beneficiary, or enrollee prior to the 
        enrollment, and in connection with such enrollment, of such 
        individual under the plan or coverage.
          ``(3) Incidental collection.--Where a group health plan or 
        health insurance issuer (in connection with health insurance 
        coverage offered in connection with a group health plan) 
        obtains genetic information incidental to the requesting, 
        requiring, or purchasing of other information concerning a 
        participant or beneficiary, such request, requirement, or 
        purchase shall not be considered a violation of this subsection 
        if--
                  ``(A) such request, requirement, or purchase is not 
                in violation of paragraph (1); and
                  ``(B) any genetic information (including information 
                about a request for or receipt of genetic services) 
                requested, required, or purchased is not used or 
                disclosed in violation of subsection (a).
  ``(c) Application of Confidentiality Standards.--The provisions of 
subsections (a) and (b) shall not apply--
          ``(1) to group health plans or health insurance issuers that 
        are not otherwise covered under the regulations promulgated by 
        the Secretary under part C of title XI of the Social Security 
        Act (42 U.S.C. 1320d et seq.) and section 264 of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note); and
          ``(2) to genetic information that is not considered to be 
        individually-identifiable health information under the 
        regulations promulgated by the Secretary under part C of title 
        XI of the Social Security Act (42 U.S.C. 1320d et seq.) and 
        section 264 of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
  ``(d) Coordination With Privacy Regulations.--The Secretary shall 
implement and administer this section in a manner that is consistent 
with the implementation and administration by the Secretary of the 
regulations promulgated by the Secretary under part C of title XI of 
the Social Security Act (42 U.S.C. 1320d et seq.) and section 264 of 
the Health Insurance Portability and Accountability Act of 1996 (42 
U.S.C. 1320d-2 note).''.
                  (B) Application to small group health plans.--Section 
                2721(a) of such Act (42 U.S.C. 300gg-21(a)) is amended 
                by inserting ``(other than section 2703)'' after 
                ``subparts 1 and 3''.
          (2) Individual health insurance.--Such title is further 
        amended by inserting after section 2744 the following new 
        section:

``SEC. 2744A. PRIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION.

  ``(a) Compliance With Certain Confidentiality Standards With Respect 
to Genetic Information.--
          ``(1) In general.--The regulations promulgated by the 
        Secretary under part C of title XI of the Social Security Act 
        (42 U.S.C. 1320d et seq.) and section 264 of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note) shall apply to the use or disclosure of genetic 
        information by an health insurance issuer in connection with 
        individual health insurance coverage.
          ``(2) Prohibition on underwriting and premium rating.--
        Notwithstanding paragraph (1), a health insurance issuer shall 
        not use or disclose genetic information (including information 
        about a request for or a receipt of genetic services by an 
        individual or family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a plan, 
        contract or coverage for health insurance or health benefits in 
        the individual market.
  ``(b) Prohibition on Collection of Genetic Information.--
          ``(1) In general.--A health insurance issuer shall not 
        request, require, or purchase genetic information (including 
        information about a request for or a receipt of genetic 
        services by an individual or family member of such individual) 
        for purposes of underwriting, determinations of eligibility to 
        enroll, premium rating, or the creation, renewal or replacement 
        of a plan, contract or coverage for health insurance or health 
        benefits in the individual market.
          ``(2) Limitation relating to the 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 
        (including information about a request for or a receipt of 
        genetic services by an individual or family member of such 
        individual) concerning an enrollee prior to the enrollment, and 
        in connection with such enrollment, of such individual under 
        the coverage.
          ``(3) Incidental collection.--Where a health insurance issuer 
        obtains genetic information incidental to the requesting, 
        requiring, or purchasing of other information concerning an 
        enrollee in the individual market, such request, requirement, 
        or purchase shall not be considered a violation of this 
        subsection if--
                  ``(A) such request, requirement, or purchase is not 
                in violation of paragraph (1); and
                  ``(B) any genetic information (including information 
                about a request for or receipt of genetic services) 
                requested, required, or purchased is not used or 
                disclosed in violation of subsection (a).
  ``(c) Application of Confidentiality Standards.--The provisions of 
subsections (a) and (b) shall not apply--
          ``(1) to health insurance issuers that are not otherwise 
        covered under the regulations promulgated by the Secretary 
        under part C of title XI of the Social Security Act (42 U.S.C. 
        1320d et seq.) and section 264 of the Health Insurance 
        Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
        note); and
          ``(2) to genetic information that is not considered to be 
        individually-identifiable health information under the 
        regulations promulgated by the Secretary under part C of title 
        XI of the Social Security Act (42 U.S.C. 1320d et seq.) and 
        section 264 of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
  ``(d) Coordination With Privacy Regulations.--The Secretary shall 
implement and administer this section in a manner that is consistent 
with the implementation and administration by the Secretary of the 
regulations promulgated by the Secretary under part C of title XI of 
the Social Security Act (42 U.S.C. 1320d et seq.) and section 264 of 
the Health Insurance Portability and Accountability Act of 1996 (42 
U.S.C. 1320d-2 note).''.
  (b) Application to Medicare Supplemental Policies.--Section 1882 of 
the Social Security Act (42 U.S.C. 1395ss), as amended by section 
103(b)(1), is amended by adding at the end the following new 
subsection:
  ``(y) Privacy and Confidentiality of Genetic Information.--
          ``(1) Compliance with certain confidentiality standards with 
        respect to genetic information.--
                  ``(A) In general.--The regulations promulgated by the 
                Secretary under part C of title XI of the Social 
                Security Act (42 U.S.C. 1320d et seq.) and section 264 
                of the Health Insurance Portability and Accountability 
                Act of 1996 (42 U.S.C. 1320d-2 note) shall apply to the 
                use or disclosure of genetic information by an issuer 
                of a medicare supplemental policy.
                  ``(B) Prohibition on underwriting and premium 
                rating.--Notwithstanding subparagraph (A), an issuer of 
                a medicare supplemental policy shall not use or 
                disclose genetic information (including information 
                about a request for or a receipt of genetic services by 
                an individual or family member of such individual) for 
                purposes of underwriting, determinations of eligibility 
                to enroll, premium rating, or the creation, renewal or 
                replacement of a plan, contract or coverage for health 
                insurance or health benefits in connection with such 
                policy.
          ``(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 (including information 
                about a request for or a receipt of genetic services by 
                an individual or family member of such individual) for 
                purposes of underwriting, determinations of eligibility 
                to enroll, premium rating, or the creation, renewal or 
                replacement of a plan, contract or coverage for health 
                insurance or health benefits in connection with such 
                policy.
                  ``(B) Limitation relating to the collection of 
                genetic information prior to enrollment.--An issuer of 
                a medicare supplemental policy shall not request, 
                require, or purchase genetic information (including 
                information about a request for or a receipt of genetic 
                services by an individual or family member of such 
                individual) concerning an enrollee prior to the 
                enrollment, and in connection with such enrollment, of 
                such individual under the policy.
                  ``(C) Incidental collection.--Where the issuer of a 
                medicare supplemental policy obtains genetic 
                information incidental to the requesting, requiring, or 
                purchasing of other information concerning an enrollee 
                in connection with such a policy, such request, 
                requirement, or purchase shall not be considered a 
                violation of this paragraph if--
                          ``(i) such request, requirement, or purchase 
                        is not in violation of subparagraph (A); and
                          ``(ii) any genetic information (including 
                        information about a request for or receipt of 
                        genetic services) requested, required, or 
                        purchased is not used or disclosed in violation 
                        of paragraph (1).
          ``(3) Application of confidentiality standards.--The 
        provisions of paragraphs (1) and (2) shall not apply--
                  ``(A) to health insurance issuers that are not 
                otherwise covered under the regulations promulgated by 
                the Secretary under part C of title XI of the Social 
                Security Act (42 U.S.C. 1320d et seq.) and section 264 
                of the Health Insurance Portability and Accountability 
                Act of 1996 (42 U.S.C. 1320d-2 note); and
                  ``(B) to genetic information that is not considered 
                to be individually-identifiable health information 
                under the regulations promulgated by the Secretary 
                under part C of title XI of the Social Security Act (42 
                U.S.C. 1320d et seq.) and section 264 of the Health 
                Insurance Portability and Accountability Act of 1996 
                (42 U.S.C. 1320d-2 note).
          ``(4) Coordination with privacy regulations.--The Secretary 
        shall implement and administer this subsection in a manner that 
        is consistent with the implementation and administration by the 
        Secretary of the regulations promulgated by the Secretary under 
        part C of title XI of the Social Security Act (42 U.S.C. 1320d 
        et seq.) and section 264 of the Health Insurance Portability 
        and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).''.

SEC. 105. ASSURING COORDINATION.

  (a) In General.--Except as provided in subsection (b), the Secretary 
of the Treasury, the Secretary of Health and Human Services, and the 
Secretary of Labor 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.
  (b) Authority of the Secretary.--The Secretary of Health and Human 
Services has the sole authority to promulgate regulations to implement 
section 104.

SEC. 106. RELATIONSHIP TO TITLE II WITH RESPECT TO ENFORCEMENT.

  With respect to the relationship between title II and this title (and 
the amendments made by this title):
          (1) The genetic nondiscrimination requirements and remedies 
        of this title (and such amendments) are exclusive for--
                  (A) group health plans;
                  (B) health or other insurance coverage issued in 
                connection with group heath plans;
                  (C) individual health insurance coverage; and
                  (D) and medicare supplemental policies.
          (2) Nothing in title II shall be construed to establish a 
        requirement or remedy under such title with respect to group 
        health plans, health or other insurance coverage issued in 
        connection with group heath plans, individual health insurance 
        coverage, or medicare supplemental policies, notwithstanding 
        any provision of such title.

SEC. 107. REGULATIONS; EFFECTIVE DATE.

  (a) Regulations.--Not later than 1 year after the date of enactment 
of this title, the Secretary of Labor, the Secretary of Health and 
Human Services, and the Secretary of the Treasury shall issue final 
regulations in an accessible format to carry out this title.
  (b) Effective Date.--Except as provided in section 103, the 
amendments made by this title shall take effect on the date that is 18 
months after the date of enactment of this Act.

TITLE II--PROHIBITING EMPLOYMENT DISCRIMINATION ON THE BASIS OF GENETIC 
                              INFORMATION

SEC. 201. DEFINITIONS.

  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 (42 U.S.C. 2000e-4).
          (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 (42 U.S.C. 2000e(f));
                          (ii) a State employee (including an 
                        applicant) described in section 304(a) of the 
                        Government Employee Rights Act of 1991 (42 
                        U.S.C. 2000e-16c(a));
                          (iii) a covered employee (including an 
                        applicant), as defined in section 101 of the 
                        Congressional Accountability Act of 1995 (2 
                        U.S.C. 1301);
                          (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 (42 
                        U.S.C. 2000e-16(a)) applies.
                  (B) Employer.--The term ``employer'' means--
                          (i) an employer (as defined in section 701(b) 
                        of the Civil Rights Act of 1964 (42 U.S.C. 
                        2000e(b));
                          (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 (42 U.S.C. 2000e).
                  (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) the spouse of the individual;
                  (B) a dependent child of the individual, including a 
                child who is born to or placed for adoption with the 
                individual; and
                  (C) all other individuals related by blood to the 
                individual or the spouse or child described in 
                subparagraph (A) or (B).
          (4) Genetic information.--
                  (A) In general.--Except as provided in subparagraph 
                (B), the term ``genetic information'' means information 
                about--
                          (i) an individual's genetic tests;
                          (ii) the genetic tests of family members of 
                        the individual; or
                          (iii) the occurrence of a disease or disorder 
                        in family members of the individual.
                  (B) Exceptions.--The term ``genetic information'' 
                shall not include information about the sex or age of 
                an 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 (such as obtaining, 
                interpreting or assessing genetic information); or
                  (C) genetic education.
          (7) Genetic test.--
                  (A) In general.--The term ``genetic test'' means the 
                analysis of human DNA, RNA, chromosomes, proteins, or 
                metabolites, that detects genotypes, mutations, or 
                chromosomal changes.
                  (B) Exception.--The term ``genetic test'' does not 
                mean an analysis of proteins or metabolites that does 
                not detect genotypes, mutations, or chromosomal 
                changes.

SEC. 202. EMPLOYER PRACTICES.

  (a) Use of 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 information about a request for or 
        the receipt of genetic services by such employee or family 
        member of such 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 (or 
        information about a request for or the receipt of genetic 
        services by such employee or family member of such 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 (or information about a request for the receipt of genetic 
services by such employee or a family member of such 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 
                bona fide wellness program;
                  (B) the employee provides prior, knowing, voluntary, 
                and written authorization;
                  (C) only the employee (or family member if the family 
                member is receiving genetic services) and the licensed 
                health care professional or board certified genetic 
                counselor involved in providing such services receive 
                individually identifiable information concerning the 
                results of such services; and
                  (D) any individually identifiable genetic information 
                provided under subparagraph (C) in connection with the 
                services provided under subparagraph (A) is only 
                available for purposes of such services and shall not 
                be disclosed to the employer except in aggregate terms 
                that do not disclose the identity of specific 
                employees;
          (3) where an employer requests or requires family medical 
        history from the employee to comply with the certification 
        provisions of section 103 of the Family and Medical Leave Act 
        of 1993 (29 U.S.C. 2613) or such requirements under State 
        family and medical leave laws;
          (4) where an employer purchases documents that are 
        commercially and publicly available (including newspapers, 
        magazines, periodicals, and books, but not including medical 
        databases or court records) that include family medical 
        history; or
          (5) where the information involved is to be used for genetic 
        monitoring of the biological effects of toxic substances in the 
        workplace, but only if--
                  (A) the employer provides written notice of the 
                genetic monitoring to the employee;
                  (B)(i) the employee provides prior, knowing, 
                voluntary, and written authorization; or
                  (ii) the genetic monitoring is required by Federal or 
                State law;
                  (C) the employee is informed of individual monitoring 
                results;
                  (D) the monitoring is in compliance with--
                          (i) any Federal genetic monitoring 
                        regulations, including any such regulations 
                        that may be promulgated by the Secretary of 
                        Labor pursuant to the Occupational Safety and 
                        Health Act of 1970 (29 U.S.C. 651 et seq.), the 
                        Federal Mine Safety and Health Act of 1977 (30 
                        U.S.C. 801 et seq.), or the Atomic Energy Act 
                        of 1954 (42 U.S.C. 2011 et seq.); or
                          (ii) State genetic monitoring regulations, in 
                        the case of a State that is implementing 
                        genetic monitoring regulations under the 
                        authority of the Occupational Safety and Health 
                        Act of 1970 (29 U.S.C. 651 et seq.); and
                  (E) the employer, excluding any licensed health care 
                professional or board certified genetic counselor that 
                is involved in the genetic monitoring program, receives 
                the results of the monitoring only in aggregate terms 
                that do not disclose the identity of specific 
                employees;
  (c) Preservation of Protections.--In the case of information to which 
any of paragraphs (1) through (5) of subsection (b) applies, such 
information may not be used in violation of paragraph (1) or (2) of 
subsection (a) or treated or disclosed in a manner that violates 
section 206.

SEC. 203. EMPLOYMENT AGENCY PRACTICES.

  (a) Use of Genetic Information.--It shall be an unlawful employment 
practice for an employment agency--
          (1) to fail or refuse to refer for employment, or otherwise 
        to discriminate against, any individual because of genetic 
        information with respect to the individual (or information 
        about a request for or the receipt of genetic services by such 
        individual or family member of such individual);
          (2) to limit, segregate, or classify individuals or fail or 
        refuse to refer for employment any individual in any way that 
        would deprive or tend to deprive any individual of employment 
        opportunities, or otherwise adversely affect the status of the 
        individual as an employee, because of genetic information with 
        respect to the individual (or information about a request for 
        or the receipt of genetic services by such individual or family 
        member of such individual); or
          (3) to cause or attempt to cause an employer to discriminate 
        against an individual in violation of this title.
  (b) Acquisition of Genetic Information.--It shall be an unlawful 
employment practice for an employment agency to request, require, or 
purchase genetic information with respect to an individual or a family 
member of the individual (or information about a request for the 
receipt of genetic services by such individual or a family member of 
such individual) except--
          (1) where an employment agency inadvertently requests or 
        requires family medical history of the individual or family 
        member of the individual;
          (2) where--
                  (A) health or genetic services are offered by the 
                employment agency, including such services offered as 
                part of a bona fide wellness program;
                  (B) the individual provides prior, knowing, 
                voluntary, and written authorization;
                  (C) only the individual (or family member if the 
                family member is receiving genetic services) and the 
                licensed health care professional or board certified 
                genetic counselor involved in providing such services 
                receive individually identifiable information 
                concerning the results of such services; and
                  (D) any individually identifiable genetic information 
                provided under subparagraph (C) in connection with the 
                services provided under subparagraph (A) is only 
                available for purposes of such services and shall not 
                be disclosed to the employment agency except in 
                aggregate terms that do not disclose the identity of 
                specific individuals;
          (3) where an employment agency requests or requires family 
        medical history from the individual to comply with the 
        certification provisions of section 103 of the Family and 
        Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements 
        under State family and medical leave laws;
          (4) where an employment agency purchases documents that are 
        commercially and publicly available (including newspapers, 
        magazines, periodicals, and books, but not including medical 
        databases or court records) that include family medical 
        history; or
          (5) where the information involved is to be used for genetic 
        monitoring of the biological effects of toxic substances in the 
        workplace, but only if--
                  (A) the employment agency provides written notice of 
                the genetic monitoring to the individual;
                  (B)(i) the individual provides prior, knowing, 
                voluntary, and written authorization; or
                  (ii) the genetic monitoring is required by Federal or 
                State law;
                  (C) the individual is informed of individual 
                monitoring results;
                  (D) the monitoring is in compliance with--
                          (i) any Federal genetic monitoring 
                        regulations, including any such regulations 
                        that may be promulgated by the Secretary of 
                        Labor pursuant to the Occupational Safety and 
                        Health Act of 1970 (29 U.S.C. 651 et seq.), the 
                        Federal Mine Safety and Health Act of 1977 (30 
                        U.S.C. 801 et seq.), or the Atomic Energy Act 
                        of 1954 (42 U.S.C. 2011 et seq.); or
                          (ii) State genetic monitoring regulations, in 
                        the case of a State that is implementing 
                        genetic monitoring regulations under the 
                        authority of the Occupational Safety and Health 
                        Act of 1970 (29 U.S.C. 651 et seq.); and
                  (E) the employment agency, excluding any licensed 
                health care professional or board certified genetic 
                counselor that is involved in the genetic monitoring 
                program, receives the results of the monitoring only in 
                aggregate terms that do not disclose the identity of 
                specific individuals;
  (c) Preservation of Protections.--In the case of information to which 
any of paragraphs (1) through (5) of subsection (b) applies, such 
information may not be used in violation of paragraph (1) or (2) of 
subsection (a) or treated or disclosed in a manner that violates 
section 206.

SEC. 204. LABOR ORGANIZATION PRACTICES.

  (a) Use of Genetic Information.--It shall be an unlawful employment 
practice for a labor organization--
          (1) to exclude or to expel from the membership of the 
        organization, or otherwise to discriminate against, any member 
        because of genetic information with respect to the member (or 
        information about a request for or the receipt of genetic 
        services by such member or family member of such member);
          (2) to limit, segregate, or classify the members of the 
        organization, or fail or refuse to refer for employment any 
        member, in any way that would deprive or tend to deprive any 
        member of employment opportunities, or otherwise adversely 
        affect the status of the member as an employee, because of 
        genetic information with respect to the member (or information 
        about a request for or the receipt of genetic services by such 
        member or family member of such member); or
          (3) to cause or attempt to cause an employer to discriminate 
        against a member in violation of this title.
  (b) Acquisition of Genetic Information.--It shall be an unlawful 
employment practice for a labor organization to request, require, or 
purchase genetic information with respect to a member or a family 
member of the member (or information about a request for the receipt of 
genetic services by such member or a family member of such member) 
except--
          (1) where a labor organization inadvertently requests or 
        requires family medical history of the member or family member 
        of the member;
          (2) where--
                  (A) health or genetic services are offered by the 
                labor organization, including such services offered as 
                part of a bona fide wellness program;
                  (B) the member provides prior, knowing, voluntary, 
                and written authorization;
                  (C) only the member (or family member if the family 
                member is receiving genetic services) and the licensed 
                health care professional or board certified genetic 
                counselor involved in providing such services receive 
                individually identifiable information concerning the 
                results of such services; and
                  (D) any individually identifiable genetic information 
                provided under subparagraph (C) in connection with the 
                services provided under subparagraph (A) is only 
                available for purposes of such services and shall not 
                be disclosed to the labor organization except in 
                aggregate terms that do not disclose the identity of 
                specific members;
          (3) where a labor organization requests or requires family 
        medical history from the members to comply with the 
        certification provisions of section 103 of the Family and 
        Medical Leave Act of 1993 (29 U.S.C. 2613) or such requirements 
        under State family and medical leave laws;
          (4) where a labor organization purchases documents that are 
        commercially and publicly available (including newspapers, 
        magazines, periodicals, and books, but not including medical 
        databases or court records) that include family medical 
        history; or
          (5) where the information involved is to be used for genetic 
        monitoring of the biological effects of toxic substances in the 
        workplace, but only if--
                  (A) the labor organization provides written notice of 
                the genetic monitoring to the member;
                  (B)(i) the member provides prior, knowing, voluntary, 
                and written authorization; or
                  (ii) the genetic monitoring is required by Federal or 
                State law;
                  (C) the member is informed of individual monitoring 
                results;
                  (D) the monitoring is in compliance with--
                          (i) any Federal genetic monitoring 
                        regulations, including any such regulations 
                        that may be promulgated by the Secretary of 
                        Labor pursuant to the Occupational Safety and 
                        Health Act of 1970 (29 U.S.C. 651 et seq.), the 
                        Federal Mine Safety and Health Act of 1977 (30 
                        U.S.C. 801 et seq.), or the Atomic Energy Act 
                        of 1954 (42 U.S.C. 2011 et seq.); or
                          (ii) State genetic monitoring regulations, in 
                        the case of a State that is implementing 
                        genetic monitoring regulations under the 
                        authority of the Occupational Safety and Health 
                        Act of 1970 (29 U.S.C. 651 et seq.); and
                  (E) the labor organization, excluding any licensed 
                health care professional or board certified genetic 
                counselor that is involved in the genetic monitoring 
                program, receives the results of the monitoring only in 
                aggregate terms that do not disclose the identity of 
                specific members;
  (c) Preservation of Protections.--In the case of information to which 
any of paragraphs (1) through (5) of subsection (b) applies, such 
information may not be used in violation of paragraph (1) or (2) of 
subsection (a) or treated or disclosed in a manner that violates 
section 206.

SEC. 205. TRAINING PROGRAMS.

  (a) Use of Genetic Information.--It shall be an unlawful employment 
practice for any employer, labor organization, or joint labor-
management committee controlling apprenticeship or other training or 
retraining, including on-the-job training programs--
          (1) to discriminate against any individual because of genetic 
        information with respect to the individual (or information 
        about a request for or the receipt of genetic services by such 
        individual or a family member of such individual) in admission 
        to, or employment in, any program established to provide 
        apprenticeship or other training or retraining;
          (2) to limit, segregate, or classify the applicants for or 
        participants in such apprenticeship or other training or 
        retraining, or fail or refuse to refer for employment any 
        individual, in any way that would deprive or tend to deprive 
        any individual of employment opportunities, or otherwise 
        adversely affect the status of the individual as an employee, 
        because of genetic information with respect to the individual 
        (or information about a request for or receipt of genetic 
        services by such individual or family member of such 
        individual); or
          (3) to cause or attempt to cause an employer to discriminate 
        against an applicant for or a participant in such 
        apprenticeship or other training or retraining in violation of 
        this title.
  (b) Acquisition of Genetic Information.--It shall be an unlawful 
employment practice for an employer, labor organization, or joint 
labor-management committee described in subsection (a) to request, 
require, or purchase genetic information with respect to an individual 
or a family member of the individual (or information about a request 
for the receipt of genetic services by such individual or a family 
member of such individual) except--
          (1) where the employer, labor organization, or joint labor-
        management committee inadvertently requests or requires family 
        medical history of the individual or family member of the 
        individual;
          (2) where--
                  (A) health or genetic services are offered by the 
                employer, labor organization, or joint labor-management 
                committee, including such services offered as part of a 
                bona fide wellness program;
                  (B) the individual provides prior, knowing, 
                voluntary, and written authorization;
                  (C) only the individual (or family member if the 
                family member is receiving genetic services) and the 
                licensed health care professional or board certified 
                genetic counselor involved in providing such services 
                receive individually identifiable information 
                concerning the results of such services;
                  (D) any individually identifiable genetic information 
                provided under subparagraph (C) in connection with the 
                services provided under subparagraph (A) is only 
                available for purposes of such services and shall not 
                be disclosed to the employer, labor organization, or 
                joint labor-management committee except in aggregate 
                terms that do not disclose the identity of specific 
                individuals;
          (3) where the employer, labor organization, or joint labor-
        management committee requests or requires family medical 
        history from the individual to comply with the certification 
        provisions of section 103 of the Family and Medical Leave Act 
        of 1993 (29 U.S.C. 2613) or such requirements under State 
        family and medical leave laws;
          (4) where the employer, labor organization, or joint labor-
        management committee purchases documents that are commercially 
        and publicly available (including newspapers, magazines, 
        periodicals, and books, but not including medical databases or 
        court records) that include family medical history; or
          (5) where the information involved is to be used for genetic 
        monitoring of the biological effects of toxic substances in the 
        workplace, but only if--
                  (A) the employer, labor organization, or joint labor-
                management committee provides written notice of the 
                genetic monitoring to the individual;
                  (B)(i) the individual provides prior, knowing, 
                voluntary, and written authorization; or
                  (ii) the genetic monitoring is required by Federal or 
                State law;
                  (C) the individual is informed of individual 
                monitoring results;
                  (D) the monitoring is in compliance with--
                          (i) any Federal genetic monitoring 
                        regulations, including any such regulations 
                        that may be promulgated by the Secretary of 
                        Labor pursuant to the Occupational Safety and 
                        Health Act of 1970 (29 U.S.C. 651 et seq.), the 
                        Federal Mine Safety and Health Act of 1977 (30 
                        U.S.C. 801 et seq.), or the Atomic Energy Act 
                        of 1954 (42 U.S.C. 2011 et seq.); or
                          (ii) State genetic monitoring regulations, in 
                        the case of a State that is implementing 
                        genetic monitoring regulations under the 
                        authority of the Occupational Safety and Health 
                        Act of 1970 (29 U.S.C. 651 et seq.); and
                  (E) the employer, labor organization, or joint labor-
                management committee, excluding any licensed health 
                care professional or board certified genetic counselor 
                that is involved in the genetic monitoring program, 
                receives the results of the monitoring only in 
                aggregate terms that do not disclose the identity of 
                specific individuals;
  (c) Preservation of Protections.--In the case of information to which 
any of paragraphs (1) through (5) of subsection (b) applies, such 
information may not be used in violation of paragraph (1) or (2) of 
subsection (a) or treated or disclosed in a manner that violates 
section 206.

SEC. 206. CONFIDENTIALITY OF GENETIC INFORMATION.

  (a) Treatment of Information as Part of Confidential Medical 
Record.--If an employer, employment agency, labor organization, or 
joint labor-management committee possesses genetic information about an 
employee or member (or information about a request for or receipt of 
genetic services by such employee or member or family member of such 
employee or member), such information shall be maintained on separate 
forms and in separate medical files and be treated as a confidential 
medical record of the employee or member.
  (b) Limitation on Disclosure.--An employer, employment agency, labor 
organization, or joint labor-management committee shall not disclose 
genetic information concerning an employee or member (or information 
about a request for or receipt of genetic services by such employee or 
member or family member of such employee or member) except--
          (1) to the employee (or family member if the family member is 
        receiving the genetic services) or member of a labor 
        organization at the request of the employee or member of such 
        organization;
          (2) to an occupational or other health researcher if the 
        research is conducted in compliance with the regulations and 
        protections provided for under part 46 of title 45, Code of 
        Federal Regulations;
          (3) in response to an order of a court, except that--
                  (A) the employer, employment agency, labor 
                organization, or joint labor-management committee may 
                disclose only the genetic information expressly 
                authorized by such order; and
                  (B) if the court order was secured without the 
                knowledge of the employee or member to whom the 
                information refers, the employer, employment agency, 
                labor organization, or joint labor-management committee 
                shall provide the employee or member with adequate 
                notice to challenge the court order;
          (4) to government officials who are investigating compliance 
        with this title if the information is relevant to the 
        investigation; or
          (5) to the extent that such disclosure is made in connection 
        with the employee's compliance with the certification 
        provisions of section 103 of the Family and Medical Leave Act 
        of 1993 (29 U.S.C. 2613) or such requirements under State 
        family and medical leave laws.
  (c) Relationship to HIPAA Regulation.--
          (1) In general.--In the case of an entity that is subject to 
        the regulations promulgated by the Secretary of Health and 
        Human Services under part C of title XI of the Social Security 
        Act (42 U.S.C. 1320d et seq.) and section 264 of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note), the entity is not subject to the provisions of 
        this title that regulate the use and disclosure of information 
        to which such regulation applies.
          (2) Rule of construction.--Nothing in paragraph (1) shall 
        affect the application of protections under this title against 
        discrimination in hiring, firing, promotion, or job placement 
        and other unlawful employment practices that do not relate to 
        the matters to which the regulations referred to in paragraph 
        (1) apply.

SEC. 207. REMEDIES AND ENFORCEMENT.

  (a) Employees Covered by Title VII of the Civil Rights Act of 1964.--
          (1) In general.--The powers, remedies, and procedures 
        provided in sections 705, 706, 707, 709, 710, and 711 of the 
        Civil Rights Act of 1964 (42 U.S.C. 2000e-4 et seq.) to the 
        Commission, the Attorney General, or any person, alleging a 
        violation of title VII of that Act (42 U.S.C. 2000e et seq.) 
        shall be the powers, remedies, and procedures this title 
        provides to the Commission, the Attorney General, or any 
        person, respectively, alleging an unlawful employment practice 
        in violation of this title against an employee described in 
        section 201(2)(A)(i), except as provided in paragraphs (2) and 
        (3).
          (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes (42 U.S.C. 1988), shall be powers, remedies, 
        and procedures this title provides to the Commission, the 
        Attorney General, or any person, alleging such a practice.
          (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes (42 U.S.C. 1981a), 
        including the limitations contained in subsection (b)(3) of 
        such section 1977A, shall be powers, remedies, and procedures 
        this title provides to the Commission, the Attorney General, or 
        any person, alleging such a practice (not an employment 
        practice specifically excluded from coverage under section 
        1977A(a)(1) of the Revised Statutes).
  (b) Employees Covered by Government Employee Rights Act of 1991.--
          (1) In general.--The powers, remedies, and procedures 
        provided in sections 302 and 304 of the Government Employee 
        Rights Act of 1991 (42 U.S.C. 2000e-16b, 2000e-16c) to the 
        Commission, or any person, alleging a violation of section 
        302(a)(1) of that Act (42 U.S.C. 2000e-16b(a)(1)) shall be the 
        powers, remedies, and procedures this title provides to the 
        Commission, or any person, respectively, alleging an unlawful 
        employment practice in violation of this title against an 
        employee described in section 201(2)(A)(ii), except as provided 
        in paragraphs (2) and (3).
          (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes (42 U.S.C. 1988), shall be powers, remedies, 
        and procedures this title provides to the Commission, or any 
        person, alleging such a practice.
          (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes (42 U.S.C. 1981a), 
        including the limitations contained in subsection (b)(3) of 
        such section 1977A, shall be powers, remedies, and procedures 
        this title provides to the Commission, or any person, alleging 
        such a practice (not an employment practice specifically 
        excluded from coverage under section 1977A(a)(1) of the Revised 
        Statutes).
  (c) Employees Covered by Congressional Accountability Act of 1995.--
          (1) In general.--The powers, remedies, and procedures 
        provided in the Congressional Accountability Act of 1995 (2 
        U.S.C. 1301 et seq.) to the Board (as defined in section 101 of 
        that Act (2 U.S.C. 1301)), or any person, alleging a violation 
        of section 201(a)(1) of that Act (42 U.S.C. 1311(a)(1)) shall 
        be the powers, remedies, and procedures this title provides to 
        that Board, or any person, alleging an unlawful employment 
        practice in violation of this title against an employee 
        described in section 201(2)(A)(iii), except as provided in 
        paragraphs (2) and (3).
          (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes (42 U.S.C. 1988), shall be powers, remedies, 
        and procedures this title provides to that Board, or any 
        person, alleging such a practice.
          (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes (42 U.S.C. 1981a), 
        including the limitations contained in subsection (b)(3) of 
        such section 1977A, shall be powers, remedies, and procedures 
        this title provides to that Board, or any person, alleging such 
        a practice (not an employment practice specifically excluded 
        from coverage under section 1977A(a)(1) of the Revised 
        Statutes).
          (4) Other applicable provisions.--With respect to a claim 
        alleging a practice described in paragraph (1), title III of 
        the Congressional Accountability Act of 1995 (2 U.S.C. 1381 et 
        seq.) shall apply in the same manner as such title applies with 
        respect to a claim alleging a violation of section 201(a)(1) of 
        such Act (2 U.S.C. 1311(a)(1)).
  (d) Employees Covered by Chapter 5 of Title 3, United States Code.--
          (1) In general.--The powers, remedies, and procedures 
        provided in chapter 5 of title 3, United States Code, to the 
        President, the Commission, the Merit Systems Protection Board, 
        or any person, alleging a violation of section 411(a)(1) of 
        that title, shall be the powers, remedies, and procedures this 
        title provides to the President, the Commission, such Board, or 
        any person, respectively, alleging an unlawful employment 
        practice in violation of this title against an employee 
        described in section 201(2)(A)(iv), except as provided in 
        paragraphs (2) and (3).
          (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes (42 U.S.C. 1988), shall be powers, remedies, 
        and procedures this title provides to the President, the 
        Commission, such Board, or any person, alleging such a 
        practice.
          (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes (42 U.S.C. 1981a), 
        including the limitations contained in subsection (b)(3) of 
        such section 1977A, shall be powers, remedies, and procedures 
        this title provides to the President, the Commission, such 
        Board, or any person, alleging such a practice (not an 
        employment practice specifically excluded from coverage under 
        section 1977A(a)(1) of the Revised Statutes).
  (e) Employees Covered by Section 717 of the Civil Rights Act of 
1964.--
          (1) In general.--The powers, remedies, and procedures 
        provided in section 717 of the Civil Rights Act of 1964 (42 
        U.S.C. 2000e-16) to the Commission, the Attorney General, the 
        Librarian of Congress, or any person, alleging a violation of 
        that section shall be the powers, remedies, and procedures this 
        title provides to the Commission, the Attorney General, the 
        Librarian of Congress, or any person, respectively, alleging an 
        unlawful employment practice in violation of this title against 
        an employee or applicant described in section 201(2)(A)(v), 
        except as provided in paragraphs (2) and (3).
          (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes (42 U.S.C. 1988), shall be powers, remedies, 
        and procedures this title provides to the Commission, the 
        Attorney General, the Librarian of Congress, or any person, 
        alleging such a practice.
          (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes (42 U.S.C. 1981a), 
        including the limitations contained in subsection (b)(3) of 
        such section 1977A, shall be powers, remedies, and procedures 
        this title provides to the Commission, the Attorney General, 
        the Librarian of Congress, or any person, alleging such a 
        practice (not an employment practice specifically excluded from 
        coverage under section 1977A(a)(1) of the Revised Statutes).
  (f) Definition.--In this section, the term ``Commission'' means the 
Equal Employment Opportunity Commission.

SEC. 208. DISPARATE IMPACT.

  (a) General Rule.--Notwithstanding any other provision of this Act, 
``disparate impact'', as that term is used in section 703(k) of the 
Civil Rights Act of 1964 (42 U.S.C. 2000e-2(k)), on the basis of 
genetic information does not establish a cause of action under this 
Act.
  (b) Commission.--On the date that is 6 years after the date of 
enactment of this Act, there shall be established a commission, to be 
known as the Genetic Nondiscrimination Study Commission (referred to in 
this section as the ``Commission'') to review the developing science of 
genetics and to make recommendations to Congress regarding whether to 
provide a disparate impact cause of action under this Act.
  (c) Membership.--
          (1) In general.--The Commission shall be composed of 8 
        members, of which--
                  (A) 1 member shall be appointed by the Majority 
                Leader of the Senate;
                  (B) 1 member shall be appointed by the Minority 
                Leader of the Senate;
                  (C) 1 member shall be appointed by the Chairman of 
                the Committee on Health, Education, Labor, and Pensions 
                of the Senate;
                  (D) 1 member shall be appointed by the ranking 
                minority member of the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (E) 1 member shall be appointed by the Speaker of the 
                House of Representatives;
                  (F) 1 member shall be appointed by the Minority 
                Leader of the House of Representatives;
                  (G) 1 member shall be appointed by the Chairman of 
                the Committee on Education and the Workforce of the 
                House of Representatives; and
                  (H) 1 member shall be appointed by the ranking 
                minority member of the Committee on Education and the 
                Workforce of the House of Representatives.
          (2) Compensation and expenses.--The members of the Commission 
        shall not receive compensation for the performance of services 
        for the Commission, but shall be allowed travel expenses, 
        including per diem in lieu of subsistence, at rates authorized 
        for employees of agencies under subchapter I of chapter 57 of 
        title 5, United States Code, while away from their homes or 
        regular places of business in the performance of services for 
        the Commission.
  (d) Administrative Provisions.--
          (1) Location.--The Commission shall be located in a facility 
        maintained by the Equal Employment Opportunity Commission.
          (2) Detail of government employees.--Any Federal Government 
        employee may be detailed to the Commission without 
        reimbursement, and such detail shall be without interruption or 
        loss of civil service status or privilege.
          (3) Information from federal agencies.--The Commission may 
        secure directly from any Federal department or agency such 
        information as the Commission considers necessary to carry out 
        the provisions of this section. Upon request of the Commission, 
        the head of such department or agency shall furnish such 
        information to the Commission.
          (4) Hearings.--The Commission may hold such hearings, sit and 
        act at such times and places, take such testimony, and receive 
        such evidence as the Commission considers advisable to carry 
        out the objectives of this section, except that, to the extent 
        possible, the Commission shall use existing data and research.
          (5) Postal services.--The Commission may use the United 
        States mails in the same manner and under the same conditions 
        as other departments and agencies of the Federal Government.
  (e) Report.--Not later than 1 year after all of the members are 
appointed to the Commission under subsection (c)(1), the Commission 
shall submit to Congress a report that summarizes the findings of the 
Commission and makes such recommendations for legislation as are 
consistent with this Act.
  (f) Authorization of Appropriations.--There are authorized to be 
appropriated to the Equal Employment Opportunity Commission such sums 
as may be necessary to carry out this section.

SEC. 209. CONSTRUCTION.

  Nothing in this title shall be construed to--
          (1) limit the rights or protections of an individual under 
        the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 et 
        seq.), including coverage afforded to individuals under section 
        102 of such Act (42 U.S.C. 12112), or under the Rehabilitation 
        Act of 1973 (29 U.S.C. 701 et seq.);
          (2)(A) limit the rights or protections of an individual to 
        bring an action under this title against an employer, 
        employment agency, labor organization, or joint labor-
        management committee for a violation of this title; or
          (B) establish a violation under this title for an employer, 
        employment agency, labor organization, or joint labor-
        management committee of a provision of the amendments made by 
        title I;
          (3) limit the rights or protections of an individual under 
        any other Federal or State statute that provides equal or 
        greater protection to an individual than the rights or 
        protections provided for under this title;
          (4) apply to the Armed Forces Repository of Specimen Samples 
        for the Identification of Remains;
          (5) limit or expand the protections, rights, or obligations 
        of employees or employers under applicable workers' 
        compensation laws;
          (6) limit the authority of a Federal department or agency to 
        conduct or sponsor occupational or other health research that 
        is conducted in compliance with the regulations contained in 
        part 46 of title 45, Code of Federal Regulations (or any 
        corresponding or similar regulation or rule); and
          (7) limit the statutory or regulatory authority of the 
        Occupational Safety and Health Administration or the Mine 
        Safety and Health Administration to promulgate or enforce 
        workplace safety and health laws and regulations.

SEC. 210. MEDICAL INFORMATION THAT IS NOT GENETIC INFORMATION.

  An employer, employment agency, labor organization, or joint labor-
management committee shall not be considered to be in violation of this 
title based on the use, acquisition, or disclosure of medical 
information that is not genetic information about a manifested disease, 
disorder, or pathological condition of an employee or member, including 
a manifested disease, disorder, or pathological condition that has or 
may have a genetic basis.

SEC. 211. REGULATIONS.

  Not later than 1 year after the date of enactment of this title, the 
Commission shall issue final regulations in an accessible format to 
carry out this title.

SEC. 212. AUTHORIZATION OF APPROPRIATIONS.

  There are authorized to be appropriated such sums as may be necessary 
to carry out this title (except for section 208).

SEC. 213. EFFECTIVE DATE.

  This title takes effect on the date that is 18 months after the date 
of enactment of this Act.

                   TITLE III--MISCELLANEOUS PROVISION

SEC. 301. SEVERABILITY.

  If any provision of this Act, an amendment made by this Act, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this Act, 
the amendments made by this Act, and the application of such provisions 
to any person or circumstance shall not be affected thereby.

                          Purpose and Summary

    H.R. 493, the Genetic Information Nondiscrimination Act of 
2007, amends the Employee Retirement Income Security Act of 
1974 (ERISA) and the Public Health Service Act (PHSA) to expand 
the prohibition against discrimination by group health plans 
and health insurance issuers in the group and individual 
markets on the basis of genetic information or services to 
prohibit: (1) enrollment and premium discrimination based on 
information about a request for or receipt of genetic services; 
and (2) requiring genetic testing. The bill also sets forth 
penalties for violations of its requirements.
    H.R. 493 amends title XVIII of the Social Security Act 
(Medicare) to prohibit issuers of Medicare supplemental 
policies from discriminating on the basis of genetic 
information. H.R. 493 also extends medical privacy and 
confidentiality rules to the disclosure of genetic information; 
makes it an unlawful employment practice for an employer, 
employment agency, labor organization, or training program to 
discriminate against an individual or deprive such individual 
of employment opportunities because of genetic information; 
prohibits the collection and disclosure of genetic information, 
with certain exceptions; and establishes a Genetic 
Nondiscrimination Study Commission to review the developing 
science of genetics and advise Congress on the advisability of 
providing for a disparate impact cause of action under the 
Civil Rights Act of 1964.

                  Background and Need for Legislation

    Deciphering the sequence of the human genome and other 
advances in genetics have opened major new opportunities for 
medical progress. Science is only beginning to unlock the 
complex nature of the interaction between genes and the 
environment in common diseases and their respective 
contributions to the disease process. The information gleaned 
from the Human Genome Project will help, and is currently 
helping, scientists and clinicians to identify common genetic 
variations that contribute to disease. Knowledge of the 
potential relevance of genetic information to the clinical 
management of nearly all patients, coupled with the lack of 
complete information about the genetic and environmental 
factors underlying diseases, creates a challenging climate for 
public policymaking.
    In many cases, the results of genetic testing may be used 
to guide clinical management of patients. For example, more 
frequent screening may be recommended for individuals at 
increased risk of certain diseases by virtue of their genetic 
make-up, such as colorectal and breast cancer. Decisions about 
course of treatment and dosing may also be guided by genetic 
testing. Many diseases, however, do not have any treatments 
available (for example, Huntington's Disease). In these cases, 
the benefits of genetic testing lie largely in the information 
they provide an individual about his or her risk of future 
disease or current disease status. The value of genetic 
information in these cases is personal to individuals, who may 
choose to utilize this information to help guide medical and 
other life decisions for themselves and their families. This 
information can affect decisions about reproduction, the types 
or amount of health, life, or disability insurance to purchase, 
or career and education choices.
    These advances give rise to the potential misuse of genetic 
information to discriminate in health insurance and employment. 
Concerns about privacy and the use and misuse of genetic 
information need to be balanced with the potential of genetics 
and genetic technology to change how care is delivered and to 
personalize medical care and treatment of disease.
    A January 20, 1998 joint report put forth by the Department 
of Labor, the Department of Health and Human Services (HHS), 
the Equal Employment Opportunity Commission (EEOC), and the 
Department of Justice (DoJ), entitled, ``Genetic Information 
and the Workplace,'' summarized the various studies on 
discrimination based on genetic information and argued for the 
enactment of Federal legislation. The joint report stated that, 
``genetic predisposition or conditions can lead to workplace 
discrimination, even in cases where workers are healthy and 
unlikely to develop disease or where the genetic condition has 
no effect on the ability to perform work.'' With these 
misconceptions so prevalent, employers may come to rely on 
genetic testing to `weed out' those employees who carry genes 
associated with diseases. The joint report concluded that 
existing protections are minimal and called for the enactment 
of legislation which states that: 1) employers should not 
require or request that employees or potential employees take a 
genetic test or provide genetic information as a condition of 
employment or benefits; 2) employers should not use genetic 
information to discriminate against, limit, segregate, or 
classify employees; and 3) employers should not obtain or 
disclose genetic information about employees or potential 
employees under most circumstances.
    The joint report acknowledged that genetic testing has the 
unique ability to detect and prevent health disorders, but 
pointed out that this information can be misused to 
discriminate against or stigmatize individuals seeking health 
insurance. It is feared that a health insurance company might 
wrongly view the presence of a gene mutation to mean that the 
person would definitely contract the disease with which that 
gene is associated and improperly deny that person insurance 
coverage. The report cited a 1996 survey of individuals at risk 
of developing a genetic condition and parents of children with 
specific genetic conditions. This report identified more than 
200 cases of genetic discrimination among the 917 people who 
responded. The cases involved discrimination by insurance 
companies, employers, and other organizations that use genetic 
information. Another survey of genetic counselors, primary care 
physicians, and patients, identified 550 people who had been 
denied employment or insurance based on their genetic 
predisposition to an illness. In addition, because an 
individual's genetic information has implications for his or 
her family members and future generations, misuse of genetic 
information could have inter-generational effects that are far 
broader than any individual incident of misuse. Furthermore, 
the joint report warned that many Americans are reluctant to 
take advantage of new breakthroughs in genetic testing for fear 
that the results will not be used to improve their health, but 
rather to deny them jobs or health insurance.
    The appropriate use of genetic information offers enormous 
opportunities to save lives and prevent the onset of disease. 
However, the medical progress made possible by genetic research 
is dependent on the willingness of study volunteers and 
patients to undergo genetic testing. Such consent may be 
difficult to obtain today. Fears about the possible misuse or 
unauthorized disclosure of genetic information appear to 
adversely impact the desire of individuals to participate in 
genetic research. Such fears also extend to clinical practice, 
discouraging both patients and providers from taking full 
advantage of genetic tests and technologies. There is 
substantial reluctance among at-risk populations to undergo 
genetic testing--even when that testing may allow patients to 
take steps to lower their risks of contracting a disease. For 
example, only 43 percent of those at risk for hereditary colon 
cancer participated in a genetic testing program. Later studies 
found that 39 percent of those who declined testing cited fears 
about the potential effect of test results on their health 
insurance coverage as the primary reason for their refusal. 
Although other factors contribute to the decision not to get 
tested, such asthe lack of an effective treatment, fear of 
genetic discrimination appears to be a primary reason that many people 
forgo getting genetic tests.
    To fill the void created by the absence of clear 
protections at the Federal level, many States have enacted laws 
that seek to prohibit genetic discrimination in health 
insurance and employment. To date, 34 States, and the District 
of Columbia, have passed laws on genetic discrimination in 
employment and 48 have passed laws on genetic discrimination in 
health insurance. Among the States that prohibit discrimination 
in the issuing of health insurance, many cover only the group 
health insurance market and exclude individual health insurance 
policies, while others do the reverse. Many States exclude 
family medical histories from their definition of genetic 
information or include only the results of tests that are 
performed with the announced intention of detecting genetic 
mutations.
    Regardless of the technical aspects of any particular State 
law, there is necessarily a significant gap in any State's 
ability to deter genetic discrimination in health insurance. 
Congress delegated to the States the authority to regulate most 
aspects of insurance through enacting the McCarran-Ferguson Act 
of 1945. However, employer-purchased plans were exempted from 
State regulation by the Employee Retirement Income Security Act 
of 1974. Under ERISA, no State may regulate the type of health 
insurance plans typically provided to employees as part of 
their employment benefits. Only the Congress can therefore 
enact a truly comprehensive law prohibiting genetic 
discrimination in all areas of health insurance.
    Federal genetic nondiscrimination legislation addresses the 
need for national comprehensive protections. The legislation is 
supported by President Bush, whose Administration has issued 
two Statement of Administration Policies (SAPs) supporting 
Senate-passed genetic nondiscrimination legislation. The most 
recent SAP, issued on February 16, 2005, stated, ``The 
Administration supports Senate passage of S. 306, as reported, 
which would prohibit group health plans and health insurers 
from denying coverage to a healthy individual or charging that 
person higher premiums based solely on a genetic predisposition 
to developing a disease in the future. The legislation would 
also bar employers from using individuals' genetic information 
when making hiring, firing, job placement, or promotion 
decisions.''
    The Committee believes the Secretary of HHS should consider 
periodically publishing non-binding guidance on whether a given 
type of analysis ``detects a genotype, mutation, or chromosomal 
change'' as those terms are used in GINA's definition of 
``genetic test''. In so doing, the Secretary should utilize an 
open and inclusive process that affords an opportunity for 
experts and stakeholders to provide the Secretary with their 
advice and input. Further, the Committee intends that at no 
point in this process should any personally identifiable 
information, including any person's genetic information or 
family history, be utilized or disclosed.

   CURRENT FEDERAL LAW ON GENETIC DISCRIMINATION IN HEALTH INSURANCE

    The Health Insurance Portability and Accountability Act 
(HIPAA) has several important limitations in protecting 
Americans against genetic discrimination in health insurance. 
First, its protections against denying coverage on the basis of 
factors related to health status apply only to the group 
insurance market. HIPAA does not address discrimination in the 
individual market, and State laws vary considerably with regard 
to restrictions on using genetic information to set premiums or 
determine eligibility. In addition, HIPAA does not prohibit an 
insurance company from raising the premiums for the group 
health plan as a whole, based on the genetic information of an 
individual in that group.

                           HIPAA AND PRIVACY

    HHS medical privacy regulations are of obvious relevance to 
the debate on genetic discrimination. While people fear 
discriminatory action based on their genes, they also fear the 
unauthorized disclosure or collection of genetic information. 
The need to protect the privacy of genetic information is 
important. Knowledge that a person has a particular medical 
condition or genetic trait may be embarrassing or damaging to 
that individual, or his or her family members. Although the HHS 
privacy regulations are extensive in many respects, they are 
limited by the underlying statutory framework of HIPAA, which 
authorized them to apply only to three named categories of 
entities: providers, payers and information clearinghouses. 
However, medical information may be widely dispersed beyond 
these `covered entities'. Due to the underlying statutory 
constraints of HIPAA, the HHS privacy regulations cannot 
directly affect employers or other non-covered entities. 
Instead, the regulations require any non-covered entity (a 
`business associate') to enter into a contract with a covered 
entity promising that it will respect the privacy of 
information transmitted from the covered entity to the non-
covered entity. Further statutory provisions are needed to 
regulate directly the collection and disclosure of genetic 
information by employers and other workforce organizations not 
covered directly within the framework of the HIPAA regulations.

    FEDERAL PROTECTIONS AGAINST GENETIC DISCRIMINATION IN EMPLOYMENT

    Federal employees have considerable protection against 
genetic discrimination under the terms of Executive Order 13145 
issued on February 10, 2000, 65 CFR 6877. Under this order, 
Federal employees may not be discharged or otherwise subjected 
to restrictions in their employment, or their employment-
related benefits, on the basis of protected genetic 
information. The Executive Order also provides protections 
against improper collection of employees' genetic information 
and against unauthorized disclosure of that information. 
Despite these protections, the Executive Order has no 
enforcement provisions.

                   TITLE VII OF THE CIVIL RIGHTS ACT

    Title VII of the Civil Rights Act of 1964 makes it illegal 
for an employer, labor organization, employment agency, or 
training program to `discriminate against any individual . . . 
because of such individual's race, color, religion, sex, or 
national origin.' While this law provides robust guarantees 
against discrimination on the basis of these characteristics, 
its applicability to genetic discrimination is limited. The 
plain language of the statute provides no explicit protection 
against genetic discrimination. Title VII may indirectly offer 
some protections against discrimination on the basis of a 
person's genetic makeup when that discrimination 
disproportionately affects individuals on the basis of one of 
the characteristics named in the Act. For acts of genetic 
discrimination that do not have a discriminatory effect on 
members of class of individuals named in the Civil Rights Act, 
Title VII would provide no apparent protection against genetic 
discrimination.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 493 on 
Thursday, March 8, 2007. The hearing was divided into two 
panels. Panel I consisted of testimony from the following: 
Francis S. Collins, M.D., Ph.D., Director, National Human 
Genome Research Institute, National Institutes of Health, 
Department of Health and Human Services; Christopher J. 
Kuczynski, J.D., Assistant Legal Counsel and Director, 
Americans with Disabilities Act Policy Division, Equal 
Employment Opportunity Commission; and Susan McAndrew, J.D., 
Deputy Director for Health Information Privacy, Office for 
Civil Rights, Department of Health and Human Services.
    Panel II consisted of testimony from the following: Sharon 
F. Terry, M.A., L.H.D., Chair, Coalition for Genetic Fairness, 
President and CEO, Genetic Alliance; William Corwin, M.D., 
Medical Director, Clinical Policy, Harvard Pilgrim Health Care, 
on behalf of the America's Health Insurance Plans (AHIP); 
Burton J. Fishman, J.D., Esq., Fortney & Scott, LLC, on behalf 
of the Genetic Information Nondiscrimination in Employment 
Coalition (GINE); Karen Pollitz, M.P.P., Research Professor, 
Georgetown University Health Policy Institute; Frank Swain, 
J.D., Senior Vice President, B&D Consulting; Janet Trautwein, 
Executive Vice President and CEO, National Association of 
Health Underwriters; Kathy Hudson, Ph.D., Director, Genetics 
and Public Policy Center, Associate Professor, Berman Institute 
of Bioethics, Johns Hopkins University.

                        Committee Consideration

    On Tuesday, March 13, 2007, the Subcommittee on Health met 
in open markup session and approved H.R. 493 for full Committee 
consideration, amended, by voice vote.
    On Friday, March 23, 2007, the full Committee met in open 
markup session and ordered H.R. 493 favorably reported to the 
House, amended, by voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken on amendments or in connection 
with ordering H.R. 493 reported. A motion by Mr. Dingell to 
order H.R. 493 favorably reported to the House, amended, was 
agreed to by voice vote.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goals and objectives of H.R. 493 are to protect 
individuals from discrimination in health insurance and 
employment on the basis of genetic information. Establishing 
these protections will allay concerns about the potential for 
discrimination and encourage individuals to participate in 
genetic research and to take advantage of genetic testing, new 
technologies, and new therapies. The legislation will provide 
substantive protections to those individuals who may suffer 
from actual genetic discrimination now and in the future.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
493 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

                  Earmarks and Tax and Tariff Benefits

    In compliance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 493 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee will adopt as its own the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

                  Congressional Budget Office Estimate

    Regarding clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, a cost estimate by the Congressional 
Budget Office pursuant to section 402 of the Congressional 
Budget Act of 1974 was not available as of the time of the 
filing of this report by the Committee.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
the provisions of Article I, section 8, clause 3, which grants 
Congress the power to regulate commerce with foreign nations, 
among the several States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does relate to the 
terms and conditions of employment or access to public services 
or accommodations within the meaning of section 102(b)(3) of 
the Congressional Accountability Act. H.R. 493 prohibits 
discrimination on the basis of genetic information with respect 
to health insurance and employment for Congressional and 
Executive Branch employees. With respect to health insurance, 
the provisions of H.R. 493 would indirectly apply to the 
Federal Employees Health Benefits Program (FEHBP), which 
contracts with insurance issuers and provides coverage to 
Members and employees of the legislative branch. The impact of 
this legislation on the FEHBP may not be relevant, however, 
given that the FEHBP already has broad non-discrimination rules 
in place, and given the fact that, pursuant to existing laws 
and regulations, eligibility for enrollment in the FEHBP is 
based solely on employment with the Federal Government, not 
medical conditions. With respect to employment, Executive Order 
13145, issued February 10, 2000, prohibits discrimination in 
Federal employment based on genetic information, and current 
laws and regulations ensure that disqualification for Federal 
employment can only be based on job-related criteria.

             Section-by-Section Analysis of the Legislation


Section 1. Short title; table of contents

    Section 1 establishes the short title as the ``Genetic 
Information Nondiscrimination Act of 2007''. This section also 
provides a table of contents.

Section 2. Findings

    Section 2 provides findings that support the overall goals 
and objectives of the bill.

        Title I--Genetic Non-Discrimination in Health Insurance


Section 101. Amendments to Employee Retirement Income Security Act of 
        1974

Subsection (a). Prohibition of health discrimination on the basis of 
        genetic information or genetic services

            Section 101(a)(1). No enrollment restriction for genetic 
                    services
    Section 101(a)(1) amends ERISA 702(a)(1)(F) to include 
``information about a request for or receipt of genetics 
services by an individual or family member of such 
individual.''
            Section 101(a)(2). No discrimination in group premiums 
                    based on genetic information
    Section 101(a)(2) amends ERISA 702(b) to prohibit a health 
insurance issuer offering group health coverage in connection 
with a group health plan from adjusting premium or contribution 
amounts for a group on the basis of genetic information 
concerning an individual in the group or a family member of the 
individual.

Section 101(b). Limitations on genetic testing

    Section 101(b) amends section 702 of ERISA to include a 
prohibition on genetic testing. Specifically, this provision 
prohibits a group health plan or a health insurance issuer 
offering group health insurance coverage in connection with a 
group health plan from requesting or requiring an individual or 
a family member of such individual to undergo a genetic test. 
This section does not limit the authority of the treating 
health care professional to request that such individual or 
family member undergo a genetic test. Nor does it limit the 
authority of a health care professional who is employed by or 
affiliated with the group health plan or health insurance 
issuer and who is providing health care services to the 
enrolled individual as part of a bona fide wellness program 
from notifying such individual about the availability of a 
genetic test or providing information about the genetic test. 
Finally, this section does not authorize or permit a health 
care professional to require that an individual undergo a 
genetic test.
    Application to All Plans--This provision applies the 
requirements of the amendments made by section 101 of the 
Genetic Information Nondiscrimination Act to small group health 
plans (and group health insurance coverage offered in 
connection with a group health plan) that are otherwise exempt, 
under section 732(a) of ERISA, from the other non-
discrimination prohibitions under section 702 of ERISA. The 
requirements of such amendments apply to a group health plan 
(and group health insurance coverage offered in connection with 
a group health plan) that, on the first day of the plan year, 
has less than two participants who are current employees for 
any plan year. Such amendments also apply to retiree only group 
health plans (and group health insurance coverage offered in 
connection with a group health plan).

Section 101(c). Remedies and enforcement

    Section 101(c) amends section 502 of ERISA to clarify and 
strengthen remedies available to group health plan participants 
for violations of the genetic nondiscrimination provisions 
added by title I.
    Secretarial Enforcement Authority--The Secretary is 
provided specific authority to issue administrative penalties 
for violation of sections 101 and 104(b).
    Amount of Penalty--The Secretary of Labor may impose a 
civil penalty against a group health plan sponsor or issuer for 
any violation of this section in the amount of $100 for each 
day of noncompliance with respect to each individual to whom 
such failure relates. A higher penalty of $2,500 for each day 
of non-compliance shall be applied where there is one or more 
failures with respect to an individual involved and where the 
plan did not correct the failure within the specified time. A 
penalty of $15,000 shall be applied if the violation under this 
title in any year is more than de minimis.

Section 101(d). Definitions

    Section 101(d) adds new definitions to section 733(d) of 
ERISA with respect to genetic non-discrimination.
    Family Member--Means the spouse of the individual, a 
dependent child, including adopted children; and all other 
individuals related by blood to the individual or the spouse or 
child.
    Genetic Information--Means information about an 
individual's genetic tests, the genetic tests of family members 
of the individual, or the occurrence of a disease or disorder 
in family members of the individual. It does not include 
information about the sex or age of an individual.
    Genetic Test--Means an analysis of human DNA, RNA, 
chromosomes, proteins, or metabolites, that detects genotypes, 
mutations, or chromosomal changes. It does not mean an analysis 
of proteins or metabolites that does not detect genotypes, 
mutations, or chromosomal changes or 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.
    Genetic Services--Means a genetic test; genetic counseling 
(including obtaining, interpreting, or assessing genetic 
information or providing genetic advice); or genetic education.

Section 101(e). Regulations and effective date

    Section 101(e) states that the Secretary of Labor shall 
issue final regulations not later than one year after 
enactment. The amendments made by this act shall apply to group 
health plans for plan years beginning 18 months after 
enactment.

Section 102. Amendments to the Public Health Service Act

Subsection (a). Amendments relating to the group market

    (1) Prohibition of Health Discrimination on the Basis of 
Genetic Information or Genetic Services--Sections 2702(a)(1)(F) 
and 2702(b) of the Public Health Service Act currently prohibit 
a group health plan and a health insurance issuer offering 
group health insurance coverage in connection with a group 
health plan from discriminating--in eligibility for enrollment 
or premium contributions--against an individual in the group 
based on the individual's health status related factors, 
including genetic information. In general, this section 
clarifies and expands this provision by prohibiting 
discrimination based on genetic information, including 
information about a request for or receipt of genetic services 
by an individual or family member of the individual.
    (A) No Enrollment Restriction for Genetic Services--This 
provision clarifies that within the existing prohibition 
banning discrimination in enrollment against an individual in 
the group that the term genetic information includes 
``information about a request for or receipt of genetics 
services by an individual or family member of such 
individual.''
    (B) No Discrimination in Group Premiums Based on Genetic 
Information--This provision prohibits a health insurance issuer 
offering group health coverage in connection with a group 
health plan from adjusting premiums or contribution amounts for 
a group on the basis of genetic information concerning an 
individual in the group or a family member of the individual.
    (2) Limitations on Genetic Testing--This section amends 
section 2702 of the Public Health Service Act to include a 
prohibition on genetic testing. Specifically, this provision 
prohibits a group health plan or a health insurance issuer 
offering group health insurance coverage in connection with a 
group health plan from requesting or requiring an individual or 
a family member of such individual to undergo a genetic test. 
Section 102 does not limit the authority of the treating health 
care professional to request that such individual or family 
member undergo a genetic test. Nor does it limit the authority 
of a health care professional who is employed by or affiliated 
with the group health plan or health insurance issuer and who 
is providing health care services to the enrolled individual as 
part of a wellness program (as defined under regulations 
implementing PHSA section 2702 at 45 CFR 146.121(f)) from 
notifying such individual about the availability of a genetic 
test or providing information about the genetic test. This 
section does not authorize or permit a health care professional 
to require that an individual undergo a genetic test. Finally, 
this section clarifies that a health insurance company can 
condition payment of an insurance claim on obtaining the 
results of a genetic test or informing members of such 
policies. However, the insurance company can only request the 
minimum amount of information necessary to accomplish their 
intended purpose. An exampleof why this would be necessary 
could include a situation where someone was getting colonoscopies every 
6 months and asking their health insurance provider to pay for these 
services. A health insurance company should have the ability to ask why 
these tests are occurring so frequently and should be able to require 
evidence as to why this is medically necessary.
    Application to All Plans--This provision applies the 
requirements of the amendments made by section 102(a) of the 
Genetic Information Nondiscrimination Act to small group health 
plans (and group health insurance coverage offered in 
connection with a group health plan) that are otherwise exempt, 
under section 2721(a) of the Public Health Service Act, from 
the nondiscrimination prohibitions under section 2702.
    Genetic Information of a Fetus or Embryo--This section 
amends title I to state that any reference to genetic 
information concerning an individual or family member shall 
also include the genetic information of any fetus carried by a 
pregnant woman and shall include the genetic information of an 
embryo legally held by an individual or family member (i.e., 
with respect to assisted reproductive technology, such as in-
vitro fertilization).
    (3) Remedies and Enforcement--This section amends section 
2722(b) of the Public Health Service Act to allow for 
enforcement of the requirements the amendments made by section 
102(a) against health insurance issuers offering group health 
insurance coverage in connection with a group health plan. The 
enforcement mechanism is the same as that created by HIPAA to 
enforce existing non-discrimination provisions against health 
insurance issuers offering group health insurance coverage in 
connection with a group health plan under section 2702 of the 
PHSA.
    Enforcement Authority Relating to Genetic Discrimination--
In cases where the Secretary of HHS determines that a State has 
failed to substantially enforce the requirements of the 
amendments made by section 102(a) against a health insurance 
issuer offering group health insurance coverage, the Secretary 
has the authority to impose a civil monetary penalty on the 
issuer.
    Amount of Penalty--The Secretary of HHS may impose a civil 
penalty against a group health plan for any violation of the 
amendments made by section 102(a) in the amount of $100 for 
each day of noncompliance with respect to each individual to 
whom such failure relates. A higher penalty of $2,500 for each 
day of non-compliance shall be applied where there are one or 
more failures with respect to an individual and where the plan 
did not correct the failure within the specified time. A 
penalty of $15,000 shall be applied where the violation under 
the amendments made by section 102(a) in any year is more than 
de minimis.
    Limitations--No penalty applies under this paragraph if the 
Secretary determines that the person did not know, or through 
reasonable diligence would not have known, that such failure 
existed. No penalty shall be imposed on any failures due to 
reasonable cause and not willful neglect; and if such failure 
is corrected within 30 days of discovery. The overall 
limitation for unintentional failures due to reasonable cause 
shall not exceed the lesser of 10 percent of the amount paid or 
incurred by the employer during the preceding taxable year for 
group health plans or $500,000. The Secretary may waive all or 
part of any penalty imposed by this section if the penalty 
would be excessive relative to the failure involved.
    (4) Definitions--This section adds new definitions to 
section 2791(d) of the PHSA with respect to genetic non-
discrimination. A `Family Member' means, with respect to an 
individual, a dependent of such individual as outlined in 
section 2701(f)(2) and any other individual up to the fourth-
degree relative of such individual or dependent. `Genetic 
Information' is defined as information about an individual's 
genetic test; the genetic tests of family members; or the 
occurrence of a disease or disorder in family members of the 
individual. This section clarifies that genetic information 
with respect to participation in clinical trials is included 
within the scope of GINA's definition of genetic information. 
Information about the sex or age of an individual is not 
included. The definitions for `Genetic Test' and `Genetic 
Services' are identical to the definitions applicable to group 
health plans under section 101.

Subsection (b). Amendment relating to the individual market

    (b)(1). This section adds a new section 2753 to subpart 2 
to title XXVII of the PHSA relating to genetic 
nondiscrimination.
            Section 2753(a)--Prohibition on genetic information as a 
                    condition of eligibility
    A health insurance issuer in the individual market may not 
establish rules for eligibility (including continued 
eligibility) for an individual to enroll for coverage based on 
genetic information (including information about a request for 
or receipt of genetic services by an individual or family 
member of such individual).
            Section 2753(b)--Prohibition on genetic information in 
                    setting premium rates
    A health insurance issuer in the individual market shall 
not adjust the premium or contribution amounts for an 
individual on the basis of such individual's genetic 
information (including information about a request for or 
receipt of genetic services).
            Section 2753(c).--Prohibition on genetic information as 
                    preexisting condition
    A health insurance issuer in the individual market shall 
not impose any preexisting condition exclusion for an 
individual on the basis of such individual's genetic 
information (including information about a request for or 
receipt of genetic services).
            Section 2753(d).--Genetic testing
    This provision prohibits a health insurance issuer in the 
individual market from requesting or requiring an individual or 
a family member of such individual to undergo a genetic test. 
This provision does not limit the authority of the treating 
health care professional to request that such individual or 
family member undergo a genetic test. Nor does it limit the 
authority of a health care professional who is employed by or 
affiliated with the group health plan or health insurance 
issuer and who is providing health care services to the 
enrolled individual as part of a wellness program (as defined 
under regulations implementing PHSA section 2702 at 45 CFR 
146.121(f)) from notifying such individual about the 
availability of a genetic test or providing information about 
the genetic test. Finally, this provision does not authorize or 
permit a health care professional to require that an individual 
undergo a genetic test.
    Genetic Information of a Fetus or Embryo--This section 
states that any reference to genetic information concerning an 
individual or family member shall also include the genetic 
information of any fetus carried by a pregnant woman and shall 
include the genetic information of an embryo legally held by an 
individual or family member (i.e., with respect to assisted 
reproductive technology, such as in-vitro fertilization).
    (2) Remedies and Enforcement--This section amends section 
2761 of the PHSA to establish the same enforcement mechanism 
and Secretarial authority against health insurance issuers in 
the individual market as is provided for enforcing the genetic 
non-discrimination provisions against health insurance issuers 
in the group market.

Subsection (c). Elimination of option of non-federal governmental plans 
        to be excepted from requirements concerning genetic information

    This subtitle creates an exception to the existing opt-out 
provision under section 2721(a)(1)(2) of the PHSA that provides 
non-Federal governmental plans the ability to opt out of 
certain requirements created by HIPAA. Therefore, all non-
Federal governmental health plans must comply with the genetic 
non-discrimination requirements created by this Act in the same 
manner as other non-governmental group health plans.

Subsection (d).--Regulations and effective date

    Not later than one year after the date of enactment of this 
title, the Secretary of Labor and the Secretary of HHS (as the 
case may be) shall issue final regulations to carry out the 
amendments made by this section. The amendments made by this 
section shall apply to group health plans and insurance for 
plan years beginning after the date that is 18 months after the 
date of the enactment of this title. The amendments made by 
this section shall apply to insurance in the individual market 
18 months after the date of enactment.

Section 103. Amendments to Title XVIII of the Social Security Act 
        relating to Medigap

Subsection (a). Nondiscrimination

            Section 103(a)(1). In general
    Section 103(a)(1) amends section 1882(s)(2) of the Social 
Security Act by adding the following:
    An issuer of a Medicare supplemental policy shall not deny 
or condition the issuance or effectiveness of the policy, and 
shall not discriminate in the pricing of the policy (including 
premium rate adjustments) of an individual on the basis of 
genetic information (or information about a request for, or 
receipt of, genetic services by such individual or family 
member of such individual).
            Section 103(a)(2). Effective date
    Section 103(a)(2) states that the amendment made in section 
103(a)(1) applies to a policy for policy years beginning after 
the date that is 18 months after the date of enactment.
            Section 103(b)(1). Limitation on genetic testing
    Section 103(b)(1) amends section of 1882 of the Social 
Security Act to prohibit an issuer of a Medicare supplemental 
policy from requesting or requiring an individual or a family 
member of such individual to undergo a genetic test. This 
provision does not limit the authority of the treating health 
care professional to request that such individual or family 
member undergo a genetic test. Nor does it limit the authority 
of a health care professional who is employed by or affiliated 
with the issuer of the Medicare supplemental policy and who is 
providing health care services to the enrolled individual as 
part of a wellness program from notifying such individual about 
the availability of a genetic test or providing information 
about the genetic test. Finally, this provision does not 
authorize or permit a health care professional to require that 
an individual undergo a genetic test.
    Definitions--The definitions of `family member,' `genetic 
information,' and `genetic test,' and `genetic services' are 
identical to the definitions applying to group health plans 
under section 101. This subsection includes the following 
additional definition:
    Issuer of a Medicare Supplemental Policy--includes a third-
party administrator or other person acting for or on behalf of 
such issuer.
            Section 103(b)(2). Conforming amendment
    Section 103(b)(2) requires an issuer to conform to and 
abide by the protections against genetic discrimination 
described in this section in order to be certified by the 
Secretary as an issuer of a Medigap policy.

Section 103(c). Transition provisions

    Section 103(c) requires the Secretary of HHS to identify 
whether a State needs to change its statutes or regulations to 
comply with this section. A State has until the earlier of the 
date the State changes its statute or regulations to conform to 
this section, or October 1, 2008 to make the necessary changes 
and will not be considered out of compliance until such date. 
The National Association of Insurance Commissioners (NAIC) 
regulations shall be considered to be the applicable NAIC model 
regulation if such regulations are updated in a timely manner 
to be consistent with the Genetic Information Nondiscrimination 
Act. If the NAIC does not modify its model regulations in the 
timeframe established, the Secretary of HHS shall, not later 
than October 1, 2008, promulgate the regulation. If a State 
requires conforming legislation but its legislature is not 
scheduled to meet in 2008, the date of required compliance 
specified by this paragraph is the first day of the first 
calendar quarter beginning after the close of the first 
legislative session of the State legislature that begins on or 
after July 1, 2008. For a State that has a 2-year legislative 
session, each year of such sessions shall be deemed to be a 
separate regular session of the State legislature.

Section 104. Privacy and confidentiality

Section 104(a). Applicability

    The provisions in this section apply to all group health 
plans and health insurance issuers that offer group health 
insurance coverage in connection with a group health plan 
without regard to section 732(a) of ERISA and section 
9831(a)(2) of the Internal Revenue Code of 1986.

Section 104(b). Compliance with certain confidentiality standards with 
        respect to genetic information

    In General--Part C of title XI of the Social Security Act 
and section 264 of HIPAA shall apply to the use and disclosure 
of genetic information by a group health plan or by a health 
insurance issuer that offers group health insurance coverage in 
connection with a group health plan.
    Prohibition on Underwriting and Premium Rating--A group 
health plan or health insurance issuer of a group health plan 
shall not use or disclose genetic information (including 
information about a request for or a receipt of genetic 
services by an individual or family member of such individual) 
for purposes of underwriting, determining eligibility to 
enroll, premium rating, or the creation, renewal or replacement 
of a plan, contract or coverage for health insurance or 
benefits.

Section 104(c). Prohibition on collection of genetic information

    (1) In General--A group health plan, health insurance 
issuer, or issuer of a Medicare supplemental policy shall not 
request, require, or purchase genetic information for purposes 
of underwriting, determining eligibility to enroll, premium 
rating, or the creation, renewal or replacement of a plan, 
contract or coverage under the plan or for health insurance or 
benefits.
    (2) Limitation Relating to the Collection of Genetic 
Information Prior to Enrollment--A group health plan, health 
insurance issuer, or issuer of Medicare supplemental policy 
shall not request, require, or purchase genetic information 
concerning a participant, beneficiary, or enrollee prior to the 
enrollment, and in connection with such enrollment, of such 
individual under the plan, coverage, or policy.
    (3) Incidental Collection--Where a group health plan, 
health insurance issuer, or issuer of a Medicare supplemental 
policy obtains genetic information incidental to the 
requesting, requiring, or purchasing of other information 
concerning an individual, such request, requirement, or 
purchase shall not be considered a violation if it is not 
obtained for purposes of underwriting as defined under 
paragraph (1) and any genetic information obtained incidentally 
is not used or disclosed in violation of the HHS medical 
privacy regulations.

Section 104(d). Application of confidentiality standards

    The requirements of this section apply only to group health 
plans, health insurance issuers, and issuers of Medicare 
supplemental policies that are otherwise covered under the HHS 
medical privacy regulations. Therefore, the health plan 
exceptions contained in the medical privacy regulations also 
apply with respect to the requirements under this section. The 
requirements of this section do not apply to genetic 
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.

Section 104(e). Enforcement

    Covered entities under this section are subject to the same 
penalties that exist for medical privacy regulations under 
sections 1176 and 1177 of the Social Security Act for privacy 
and confidentiality violations of genetic information under 
section 104.

Section 104(f). Preemption

    The preemption provision for this section is the same 
standard that exists for the medical privacy regulations. 
Specifically, a requirement under this section shall supersede 
any contrary provision of State law unless such provision of 
State law imposes requirements, standards, or implementation 
specifications that are more stringent than those imposed under 
this section. No penalty, remedy, or cause of action to enforce 
such State law that is more stringent shall be preempted by 
this section. This provision shall not be construed to 
establish a penalty, remedy, or cause of action under State law 
if it is not otherwise available under State law.

Section 104(g). Coordination with privacy regulations

    The Secretary of HHS shall implement and administer this 
section in a manner that is consistent with the medical privacy 
regulations.
            Section 104(h)(1). Definitions
    The definitions of `family member,' `genetic information,' 
`genetic services,' and `genetic test' are identical to the 
definitions in section 2791 of the PHSA, as amended by the 
bill.
    (2) Group Health Plan/Health Insurance Issuer--These terms 
include only those plans and issuers that are otherwise covered 
under subsection (d)(1).
    (3) Secretary--This term means the Secretary of Health and 
Human Services.

Section 104A. Privacy and confidentiality

Section 104A(a). PHSA provisions

            Section 104A(a)(1). Group health plans
    This section amends title XXVII of the PHSA by adding a new 
section 2703:

Section 2703. Privacy and confidentiality of genetic information

    (a) Compliance with Certain Confidentiality Standards with 
Respect to Genetic Information--The regulations established by 
the Secretary in part C of title XI of the Social Security Act 
and section 264 of HIPAA shall apply to the use or disclosure 
of genetic information in the group health market. A group 
health plan or health insurance insurer (in connection with 
health insurance coverage offered in connection with a group 
health plan) shall not use or disclose genetic information 
(including information about a request for or a receipt of 
genetic services by an individual or family member of such 
individual) for purposes of underwriting, determining 
eligibility, setting premiums, or creating, renewing or 
replacing a health plan.
    (b) Prohibition on Collection of Genetic Information--
    (1) In General--A group health plan or health insurance 
issuer (in connection with health insurance coverage offered in 
connection with a group health plan) shall not request, 
require, or purchase genetic information (including information 
about a request for or a receipt of genetic services by an 
individual or family member of such individual) for purposes of 
underwriting, determining eligibility to enroll, premium 
rating, or the creation, renewal or replacement of a plan, 
contract or coverage under the plan or for health insurance or 
benefits.
    (2) Limitation Relating to the Collection of Genetic 
Information Prior to Enrollment--A group health plan or health 
insurance issuer (in connection with health insurance coverage 
offered in connection with a group health plan) shall not 
request, require, or purchase genetic information (including 
information about a request for or a receipt of genetic 
services by an individual or family member of such individual) 
concerning a participant, beneficiary, or enrollee prior to the 
enrollment, and in connection with such enrollment, of such 
individual under the plan or coverage.
    (3) Incidental Collection--Where a group health plan or 
health insurance issuer (in connection with health insurance 
coverage offered in connection with a group health plan) 
obtains genetic information incidental to the requesting, 
requiring, or purchasing of other information concerning an 
individual, such request, requirement, or purchase shall not be 
considered a violation if it is not obtained for purposes of 
underwriting as defined under paragraph (1) and any genetic 
information obtained incidentally is not used or disclosed in 
violation of the HHS medical privacy regulations.
    (c) Application of Confidentiality Standards--The 
requirements of this section apply only to group health plans 
and health insurance issuers that are otherwise covered under 
the HHS medical privacy regulations. Therefore, the health plan 
exceptions contained in the medical privacy regulations also 
apply with respect to the requirements under this section. The 
requirements of this section do not apply to genetic 
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
    (d) Coordination with Privacy Regulations--The Secretary of 
HHS shall implement and administer this section in a manner 
that is consistent with the medical privacy regulations.
    (B) Application to Small Group Health Plans
    This section amends section 2721(a) of the PHSA. Certain 
small group health plans are currently exempt from the 
requirements of subparts 1 and 3 of title XXVII of the PHSA. 
These groups will continue to receive this exemption, but will 
not be exempt from section 2703 of the PHSA.
            Section 104A(a)(2). Individual health insurance
    This section amends title XXVII of the PHSA by adding a new 
section 2745:

Section 2745. Privacy and confidentiality of genetic information

    (a) Compliance with Certain Confidentiality Standards with 
Respect to Genetic Information--The regulations established by 
the Secretary in part C of title XI of the Social Security Act 
and section 264 of HIPAA shall apply to the use or disclosure 
of genetic information in the individual health insurance 
market. A health insurance insurer shall not use or disclose 
genetic information (including information about a request for 
or a receipt of genetic services by an individual or family 
member of such individual) for purposes of underwriting, 
determining eligibility, setting premiums, or creating, 
renewing or replacing a health plan.
    (b) Prohibition on Collection of Genetic Information--
    (1) In General--A health insurance issuer shall not 
request, require, or purchase genetic information (including 
information about a request for or a receipt of genetic 
services by an individual or family member of such individual) 
for purposes of underwriting, determining eligibility to 
enroll, premium rating, or the creation, renewal or replacement 
of a plan, contract or coverage under the plan or for health 
insurance or benefits.
    (2) Limitation Relating to the Collection of Genetic 
Information Prior to Enrollment--A health insurance issuer 
shall not request, require, or purchase genetic information 
(including information about a request for or a receipt of 
genetic services by an individual or family member of such 
individual) concerning a participant, beneficiary, or enrollee 
prior to the enrollment, and in connection with such 
enrollment, of such individual under the coverage.
    (3) Incidental Collection--Where a health insurance issuer 
obtains genetic information incidental to the requesting, 
requiring, or purchasing of other information concerning an 
individual, such request, requirement, or purchase shall not be 
considered a violation if it is not obtained for purposes of 
underwriting as defined under paragraph (1) and any genetic 
information obtained incidentally is not used or disclosed in 
violation of the HHS medical privacy regulations.
    (c) Application of Confidentiality Standards--The 
requirements of this section apply only to health insurance 
issuers that are otherwise coveredunder the HHS medical privacy 
regulations. Therefore, the health plan exceptions contained in the 
medical privacy regulations also apply with respect to the requirements 
under this section. The requirements of this section do not apply to 
genetic information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
    (d) Coordination with Privacy Regulations--The Secretary of 
HHS shall implement and administer this section in a manner 
that is consistent with the medical privacy regulations.

Section 104A(b). Application to Medicare supplemental policies

    This section amends section 1882 of the Social Security Act 
by adding a new section (x):
    (x) Privacy and Confidentiality of Genetic Information.
    (1) Compliance with Certain Confidentiality Standards with 
Respect to Genetic Information--The regulations established by 
the Secretary in part C of title XI of the Social Security Act 
and section 264 of HIPAA shall apply to the use or disclosure 
of genetic information in by an issuer of a medicare 
supplemental policy. An issuer of a medicare supplemental 
policy shall not use or disclose genetic information (including 
information about a request for or a receipt of genetic 
services by an individual or family member of such individual) 
for purposes of underwriting, determining eligibility, setting 
premiums, or creating, renewing or replacing a plan, contract 
or coverage.
    (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 
(including information about a request for or a receipt of 
genetic services by an individual or family member of such 
individual) for purposes of underwriting, determining 
eligibility to enroll, premium rating, or the creation, renewal 
or replacement of a plan, contract or coverage.
    (B) Limitation Relating to the Collection of Genetic 
Information Prior to Enrollment--An issuer of a medicare 
supplemental policy shall not request, require, or purchase 
genetic information (including information about a request for 
or a receipt of genetic services by an individual or family 
member of such individual) concerning an enrollee prior to the 
enrollment, and in connection with such enrollment, of such 
individual under the policy.
    (C) Incidental Collection--Where the issuer of a medicare 
supplemental policy obtains genetic information incidental to 
the requesting, requiring, or purchasing of other information 
concerning an enrollee, such request, requirement, or purchase 
shall not be considered a violation if it is not obtained for 
purposes of underwriting as defined under paragraph (1) and any 
genetic information obtained incidentally is not used or 
disclosed in violation of the HHS medical privacy regulations.
    (3) Application of Confidentiality Standards--The 
requirements of this section apply only to health insurance 
issuers that are otherwise covered under the HHS medical 
privacy regulations. Therefore, the health plan exceptions 
contained in the medical privacy regulations also apply with 
respect to the requirements under this section. The 
requirements of this section do not apply to genetic 
information that is not considered to be individually-
identifiable under HHS medical privacy regulations.
    (d) Coordination with Privacy Regulations--The Secretary of 
HHS shall implement and administer this section in a manner 
that is consistent with the medical privacy regulations.

Section 105. Assuring coordination

    Section 105 states that the Secretaries of Health and Human 
Services, Labor and Treasury shall ensure, through the 
execution of an interagency memorandum of understanding, that 
regulations, rulings, and interpretations are administered to 
have the same effect when there are two or more agencies of 
jurisdiction. Such Secretaries shall pursue coordinated 
enforcement strategies and assign priorities in enforcement.

Section 106. Relationship to title II with respect to enforcement

    Section 106 states that the requirements of title I apply 
to group health plans; health or other insurance coverage 
issued in connection with group health plans, individual health 
insurance coverage, and medicare supplemental policies. Nothing 
in title II shall affect these entities.

Section 107. Regulations; effective date

    Section 107 states that no later than one year after the 
date of enactment, the Secretaries of HHS, Labor and Treasury 
shall issue final regulations. The amendments made by this 
title shall take effect 18 months after enactment, except as 
provided in section 103.

Title II--Prohibiting Employment Discrimination on the Basis of Genetic 
                              Information


Section 201. Definitions

    Section 201 defines the term Commission and the parties 
covered by the act--employee, employer, employment agency, 
labor organization, member--and ensures that State, Federal and 
congressional employees receive the same protections as other 
employees who are covered by this act. Family members are 
defined as the spouse or dependent child of an individual, 
including a child who is born to or placed for adoption with 
the individual, and all other individuals related by blood to 
the individual or his/her spouse. Genetic information is 
defined as information about genetic tests of an individual or 
his/her family member. Genetic information also means 
information about the occurrence of disease or disorder in 
family members of the individual. It does not, however, include 
information about the sex or age of an individual. Genetic 
monitoring is defined as the periodic examination of employees 
to evaluate acquired modifications to their genetic material 
that may have occurred during employment. Genetic test is 
defined as the analysis of human DNA, RNA, chromosomes, 
proteins, or metabolites for certain reasons. It does not, 
however, include analysis that does not detect genotypes, 
mutations, or chromosomal changes. The section defines genetic 
services consistent with title I.

Section 202. Employer practices

    Section 202 makes it unlawful for an employer to request, 
require or purchase genetic information. Several specific 
exceptions are included: where an employer inadvertently 
requests or requires family medical history information; 
pursuant to an employer-sponsored wellness program; where the 
information relating to a family member is requested or 
required to comply with the certification provisions of Federal 
or State family and medical leave laws; where an employer 
purchases family medical history information that is publicly 
available through such items as newspapers, periodicals and 
books; or where the information is used for genetic monitoring 
of the biological effects of toxic substances in the workplace. 
Despite lawful acquisition of the information through these 
exceptions, the section makes clear that the employer still may 
not use or disclose the information in violation of the title.

Section 203. Employment agency practices

    Section 203 extends parallel obligations and exceptions to 
employment agencies as apply to employers under section 202.

Section 204. Labor organization practices

    Section 204 extends parallel obligations and exceptions to 
labor organizations as apply to employers under section 202.

Section 205. Training programs

    Section 205 extends parallel obligations and exceptions to 
joint labor-management committees as apply to employers under 
section 202.

Section 206. Confidentiality of genetic information

    Section 206 provides that an individual's genetic 
information shall be treated and maintained as part of the 
individual's confidential medical records. The information 
shall be maintained on separate forms and in separate medical 
files.
    Disclosure is prohibited, except to: the individual; an 
occupational or health researcher; in response to an order of a 
court; to government officials investigating compliance with 
this title; or to the extent that disclosure is made in 
connection with the employee's compliance with the 
certification provisions of section 103 of the Family and 
Medical Leave Act, or such requirements under State family and 
medical leave laws.
    This section also states that HIPAA-covered entities will 
remain covered by HIPAA. Non-HIPAA covered entities will be 
covered by this Act.

Section 207. Remedies and enforcement

    Section 207 incorporates by reference the powers, remedies, 
and procedures set forth in title VII of the Civil Rights Act 
of 1964, as amended. Similar powers, remedies and procedures 
are specified for State, Federal and congressional employees.

Section 208. Disparate impact

    Section 208 prohibits claims based on disparate impact, and 
establishes a commission to review the science of genetics and 
make recommendations to Congress regarding whether to provide a 
disparate impact cause of action under the Civil Rights Act of 
1964.

Section 209. Construction

    Section 209 provides several rules of construction to 
clarify the intent of the Committee and to assist courts in 
interpreting the title. The section makes clear that this title 
shall not be construed to limit the rights or protections of 
individuals under the Americans with Disabilities Act or the 
Rehabilitation Act of 1973. Similarly, the section clarifies 
that title II does not create violations for employers, 
employment agencies, labor organizations, or joint labor-
management committees of provisions under title I; section 106 
also relates to this issue. The section clarifies that the Act 
sets the floor for individual rights and protections and does 
not limit the rights and protections under other Federal or 
State laws. Workers compensation laws are neither expanded nor 
restricted by the bill. Finally, the section provides rules of 
construction to ensure the proper operation of Federal programs 
and laws, including the Armed Services Repository of Specimen 
Samples, occupational health and safety research, and workplace 
safety and health laws and regulations.

Section 210. Medical information that is not genetic information

    Section 210 makes clear that the Act does not extend to 
manifested diseases and illnesses.

Section 211. Regulations

    Section 211 states that not later than one year after the 
date of enactment of this title, the Genetic Nondiscrimination 
Study Commission shall issue final regulations to carry out 
this title.

Section 212. Authorization of appropriations

    Section 212 authorizes the appropriation of such sums as 
may be necessary to carry out this title, except for section 
208.

Section 213. Effective date

    Section 213 states that this title takes effect 18 months 
after the date of enactment.

                        Title III--Miscellaneous


Section 301. Severability

    Section 301 states that if any provision of this Act is 
held to be unconstitutional, the remainder of the Act shall not 
be affected thereby.

         Changes in Existing Law Made by the Bill, as Reported

    In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974

           *       *       *       *       *       *       *



TITLE I--PROTECTION OF EMPLOYEE BENEFIT RIGHTS

           *       *       *       *       *       *       *



Subtitle B--Regulatory Provisions 

           *       *       *       *       *       *       *



Part 5--Administration and Enforcement

           *       *       *       *       *       *       *



                           CIVIL ENFORCEMENT

  Sec. 502. (a)  * * *

           *       *       *       *       *       *       *

  (c) Genetic Testing.--
          (1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, or 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.--Nothing in this part shall 
        be construed to--
                  (A) limit the authority of a health care 
                professional who is providing health care 
                services with respect to an individual to 
                request that such individual or a family member 
                of such individual undergo a genetic test;
                  (B) limit the authority of a health care 
                professional who is employed by or affiliated 
                with a group health plan or a health insurance 
                issuer and who is providing health care 
                services to an individual as part of a bona 
                fide wellness program to notify such individual 
                of the availability of a genetic test or to 
                provide information to such individual 
                regarding such genetic test; or
                  (C) authorize or permit a health care 
                professional to require that an individual 
                undergo a genetic test.
  (d) Application to All Plans.--The provisions of subsections 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans 
and health insurance issuers without regard to section 732(a).

           *       *       *       *       *       *       *


                 Part 7--Group Health Plan Requirements

     Subpart A--Requirements Relating to Portability, Access, and 
Renewability

           *       *       *       *       *       *       *


SEC. 702. PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL PARTICIPANTS 
                    AND BENEFICIARIES BASED ON HEALTH STATUS.

  (a) In Eligibility To Enroll.--
          (1) In general.--Subject to paragraph (2), a group 
        health plan, and a health insurance issuer offering 
        group health insurance coverage in connection with a 
        group health plan, may not establish rules for 
        eligibility (including continued eligibility) of any 
        individual to enroll under the terms of the plan based 
        on any of the following health status-related factors 
        in relation to the individual or a dependent of the 
        individual:
                  (A)  * * *

           *       *       *       *       *       *       *

                  (F) Genetic information (including 
                information about a request for or receipt of 
                genetic services by an individual or family 
                member of such individual).

           *       *       *       *       *       *       *

  (b) In Premium Contributions.--
          (1)  * * *
          (2) Construction.--Nothing in paragraph (1) shall be 
        construed--
                  (A) to restrict the amount that an employer 
                may be charged for coverage under a group 
                health plan except as provided in paragraph 
                (3); or

           *       *       *       *       *       *       *

          (3) No discrimination in group premiums based on 
        genetic information.--For purposes of this section, a 
        group health plan, or a health insurance issuer 
        offering group health insurance coverage in connection 
        with a group health plan, shall not adjust premium or 
        contribution amounts for a group on the basis of 
        genetic information concerning an individual in the 
        group or a family member of the individual (including 
        information about a request for or receipt of genetic 
        services by an individual or family member of such 
        individual).
  (c) Genetic Testing.--
          (1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, or 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.--Nothing in this part shall 
        be construed to--
                  (A) limit the authority of a health care 
                professional who is providing health care 
                services with respect to an individual to 
                request that such individual or a family member 
                of such individual undergo a genetic test;
                  (B) limit the authority of a health care 
                professional who is employed by or affiliated 
                with a group health plan or a health insurance 
                issuer and who is providing health care 
                services to an individual as part of a bona 
                fide wellness program to notify such individual 
                of the availability of a genetic test or to 
                provide information to such individual 
                regarding such genetic test; or
                  (C) authorize or permit a health care 
                professional to require that an individual 
                undergo a genetic test.
  (d) Application to All Plans.--The provisions of subsections 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans 
and health insurance issuers without regard to section 732(a).

           *       *       *       *       *       *       *


Subpart C--General Provisions

           *       *       *       *       *       *       *


SEC. 733. DEFINITIONS.

  (a)  * * *

           *       *       *       *       *       *       *

  (d) Other Definitions.--For purposes of this part--
          (1)  * * *

           *       *       *       *       *       *       *

          (5) Family member.--The term ``family member'' means 
        with respect to an individual--
                  (A) the spouse of the individual;
                  (B) a dependent child of the individual, 
                including a child who is born to or placed for 
                adoption with the individual; and
                  (C) all other individuals related by blood to 
                the individual or the spouse or child described 
                in subparagraph (A) or (B).
          (6) Genetic information.--
                  (A) In general.--Except as provided in 
                subparagraph (B), the term ``genetic 
                information'' means information about--
                          (i) an individual's genetic tests;
                          (ii) the genetic tests of family 
                        members of the individual; or
                          (iii) the occurrence of a disease or 
                        disorder in family members of the 
                        individual.
                  (B) Exclusions.--The term ``genetic 
                information'' shall not include information 
                about the sex or age of an 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 (such as obtaining, 
                interpreting, or assessing genetic 
                information); or
                  (C) genetic education.

           *       *       *       *       *       *       *

                              ----------                              


PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *


    TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE

                      Part A--Group Market Reforms

Subpart 1--Portability, Access, and Renewability Requirements

           *       *       *       *       *       *       *


SEC. 2702. PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL PARTICIPANTS 
                    AND BENEFICIARIES BASED ON HEALTH STATUS.

  (a) In Eligibility To Enroll.--
          (1) In general.--Subject to paragraph (2), a group 
        health plan, and a health insurance issuer offering 
        group health insurance coverage in connection with a 
        group health plan, may not establish rules for 
        eligibility (including continued eligibility) of any 
        individual to enroll under the terms of the plan based 
        on any of the following health status-related factors 
        in relation to the individual or a dependent of the 
        individual:
                  (A)  * * *
          * * * * * * *
                  (F) Genetic information (including 
                information about a request for or receipt of 
                genetic services by an individual or family 
                member of such individual).
          * * * * * * *
  (b) In Premium Contributions.--
          (1)  * * *
          (2) Construction.--Nothing in paragraph (1) shall be 
        construed--
                  (A) to restrict the amount that an employer 
                may be charged for coverage under a group 
                health plan, except as provided in paragraph 
                (3); or
          * * * * * * *
          (3) No discrimination in group premiums based on 
        genetic information.--For purposes of this section, a 
        group health plan, or a health insurance issuer 
        offering group health insurance coverage in connection 
        with a group health plan, shall not adjust premium or 
        contribution amounts for a group on the basis of 
        genetic information concerning an individual in the 
        group or a family member of the individual (including 
        information about a request for or receipt of genetic 
        services by an individual or family member of such 
        individual).''.
  (c) Genetic Testing.--
          (1) Limitation on requesting or requiring genetic 
        testing.--A group health plan, or 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) Certain rules of construction.--Nothing in this 
        part shall be construed to--
                  (A) limit the authority of a health care 
                professional who is providing health care 
                services with respect to an individual to 
                request that such individual or a family member 
                of such individual undergo a genetic test;
                  (B) limit the authority of a health care 
                professional who is employed by or affiliated 
                with a group health plan or a health insurance 
                issuer and who is providing health care 
                services to an individual as part of a bona 
                fide wellness program to notify such individual 
                of the availability of a genetic test or to 
                provide information to such individual 
                regarding such genetic test; or
                  (C) authorize or permit a health care 
                professional to require that an individual 
                undergo a genetic test.
          (3) Rule of construction regarding payment.--
                  (A) In general.--Subject to subparagraph (B), 
                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 conditioning payment on obtaining 
                the results of a genetic test or informing 
                members of such policies. For purpose of the 
                preceding sentence, the term ``payment'' 
                includes reimbursement, billing, claims 
                management, claims adjudication, review of 
                health care services with respect to medical 
                necessity, coverage under a health plan, 
                appropriateness of care, or justification of 
                charges, and utilization review (including 
                precertification, prior authorization, 
                concurrent and retrospective review).
                  (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.
  (d) Application to All Plans.--The provisions of subsections 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans 
and health insurance issuers without regard to section 2721(a).
  (e) 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--
          (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.

SEC. 2703. PRIVACY AND CONFIDENTIAL OF GENETIC INFORMATION.

  (a) Compliance With Certain Confidentiality Standards With 
Respect to Genetic Information.--
          (1) In general.--The regulations promulgated by the 
        Secretary under part C of title XI of the Social 
        Security Act (42 U.S.C. 1320d et seq.) and section 264 
        of the Health Insurance Portability and Accountability 
        Act of 1996 (42 U.S.C. 1320d-2 note) shall apply to the 
        use or disclosure of genetic information by a group 
        health plan or by an health insurance issuer in 
        connection with health insurance coverage offered in 
        connection with a group health plan.
          (2) Prohibition on underwriting and premium rating.--
        Notwithstanding paragraph (1), a group health plan or a 
        health insurance issuer (in connection with health 
        insurance coverage offered in connection with a group 
        health plan) shall not use or disclose genetic 
        information (including information about a request for 
        or a receipt of genetic services by an individual or 
        family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, 
        premium rating, or the creation, renewal or replacement 
        of a plan, contract or coverage for health insurance or 
        health benefits.
  (b) Prohibition on Collection of Genetic Information.--
          (1) In general.--A group health plan or health 
        insurance issuer (in connection with health insurance 
        coverage offered in connection with a group health 
        plan) shall not request, require, or purchase genetic 
        information (including information about a request for 
        or a receipt of genetic services by an individual or 
        family member of such individual) for purposes of 
        underwriting, determinations of eligibility to enroll, 
        premium rating, or the creation, renewal or replacement 
        of a plan, contract or coverage for health insurance or 
        health benefits.
          (2) Limitation relating to the collection of genetic 
        information prior to enrollment.--A group health plan 
        or health insurance issuer (in connection with health 
        insurance coverage offered in connection with a group 
        health plan) shall not request, require, or purchase 
        genetic information (including information about a 
        request for or a receipt of genetic services by an 
        individual or family member of such individual) 
        concerning a participant, beneficiary, or enrollee 
        prior to the enrollment, and in connection with such 
        enrollment, of such individual under the plan or 
        coverage.
          (3) Incidental collection.--Where a group health plan 
        or health insurance issuer (in connection with health 
        insurance coverage offered in connection with a group 
        health plan) obtains genetic information incidental to 
        the requesting, requiring, or purchasing of other 
        information concerning a participant or beneficiary, 
        such request, requirement, or purchase shall not be 
        considered a violation of this subsection if--
                  (A) such request, requirement, or purchase is 
                not in violation of paragraph (1); and
                  (B) any genetic information (including 
                information about a request for or receipt of 
                genetic services) requested, required, or 
                purchased is not used or disclosed in violation 
                of subsection (a).
  (c) Application of Confidentiality Standards.--The provisions 
of subsections (a) and (b) shall not apply--
          (1) to group health plans or health insurance issuers 
        that are not otherwise covered under the regulations 
        promulgated by the Secretary under part C of title XI 
        of the Social Security Act (42 U.S.C. 1320d et seq.) 
        and section 264 of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note); 
        and
          (2) to genetic information that is not considered to 
        be individually-identifiable health information under 
        the regulations promulgated by the Secretary under part 
        C of title XI of the Social Security Act (42 U.S.C. 
        1320d et seq.) and section 264 of the Health Insurance 
        Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note).
  (d) Coordination With Privacy Regulations.--The Secretary 
shall implement and administer this section in a manner that is 
consistent with the implementation and administration by the 
Secretary of the regulations promulgated by the Secretary under 
part C of title XI of the Social Security Act (42 U.S.C. 1320d 
et seq.) and section 264 of the Health Insurance Portability 
and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).

           *       *       *       *       *       *       *


         Subpart 4--Exclusion of Plans; Enforcement; Preemption

SEC. 2721. EXCLUSION OF CERTAIN PLANS.

  (a) Exception for Certain Small Group Health Plans.--The 
requirements of subparts 1 and 3 (other than section 2703) 
shall not apply to any group health plan (and health insurance 
coverage offered in connection with a group health plan) for 
any plan year if, on the first day of such plan year, such plan 
has less than 2 participants who are current employees.
  (b) Limitation on Application of Provisions Relating to Group 
Health Plans.--
          (1)  * * *
          (2) Treatment of nonfederal governmental plans.--
                  (A) Election to be excluded.--[If the plan 
                sponsor] Except as provided in subparagraph 
                (D), if the plan sponsor of a nonfederal 
                governmental plan which is a group health plan 
                to which the provisions of subparts 1 through 3 
                otherwise apply makes an election under this 
                subparagraph (in such form and manner as the 
                Secretary may by regulations prescribe), then 
                the requirements of such subparts insofar as 
                they apply directly to group health plans (and 
                not merely to group health insurance coverage) 
                shall not apply to such governmental plans for 
                such period except as provided in this 
                paragraph.

           *       *       *       *       *       *       *

                  (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) and (c) of section 2702 
                and the provisions of section 2702(b) to the 
                extent that such provisions apply to genetic 
                information (or information about a request for 
                or the receipt of genetic services by an 
                individual or a family member of such 
                individual).

SEC. 2722. ENFORCEMENT.

  (a)  * * *
  (b) Secretarial Enforcement Authority.--
          (1)  * * *

           *       *       *       *       *       *       *

          (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 following provisions 
                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), or (c) of section 2702 or section 2701 
                or 2702(b)(1) with respect to genetic 
                information.
                  (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 individual 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 such 
                                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.

           *       *       *       *       *       *       *


SEC. 2744A. PRIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION.

  (a) Compliance With Certain Confidentiality Standards With 
Respect to Genetic Information.--
          (1) In general.--The regulations promulgated by the 
        Secretary under part C of title XI of the Social 
        Security Act (42 U.S.C. 1320d et seq.) and section 264 
        of the Health Insurance Portability and Accountability 
        Act of 1996 (42 U.S.C. 1320d-2 note) shall apply to the 
        use or disclosure of genetic information by an health 
        insurance issuer in connection with individual health 
        insurance coverage.
          (2) Prohibition on underwriting and premium rating.--
        Notwithstanding paragraph (1), a health insurance 
        issuer shall not use or disclose genetic information 
        (including information about a request for or a receipt 
        of genetic services by an individual or family member 
        of such individual) for purposes of underwriting, 
        determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a 
        plan, contract or coverage for health insurance or 
        health benefits in the individual market.
  (b) Prohibition on Collection of Genetic Information.--
          (1) In general.--A health insurance issuer shall not 
        request, require, or purchase genetic information 
        (including information about a request for or a receipt 
        of genetic services by an individual or family member 
        of such individual) for purposes of underwriting, 
        determinations of eligibility to enroll, premium 
        rating, or the creation, renewal or replacement of a 
        plan, contract or coverage for health insurance or 
        health benefits in the individual market.
          (2) Limitation relating to the 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 (including information 
        about a request for or a receipt of genetic services by 
        an individual or family member of such individual) 
        concerning an enrollee prior to the enrollment, and in 
        connection with such enrollment, of such individual 
        under the coverage.
          (3) Incidental collection.--Where a health insurance 
        issuer obtains genetic information incidental to the 
        requesting, requiring, or purchasing of other 
        information concerning an enrollee in the individual 
        market, such request, requirement, or purchase shall 
        not be considered a violation of this subsection if--
                  (A) such request, requirement, or purchase is 
                not in violation of paragraph (1); and
                  (B) any genetic information (including 
                information about a request for or receipt of 
                genetic services) requested, required, or 
                purchased is not used or disclosed in violation 
                of subsection (a).
  (c) Application of Confidentiality Standards.--The provisions 
of subsections (a) and (b) shall not apply--
          (1) to health insurance issuers that are not 
        otherwise covered under the regulations promulgated by 
        the Secretary under part C of title XI of the Social 
        Security Act (42 U.S.C. 1320d et seq.) and section 264 
        of the Health Insurance Portability and Accountability 
        Act of 1996 (42 U.S.C. 1320d-2 note); and
          (2) to genetic information that is not considered to 
        be individually-identifiable health information under 
        the regulations promulgated by the Secretary under part 
        C of title XI of the Social Security Act (42 U.S.C. 
        1320d et seq.) and section 264 of the Health Insurance 
        Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note).
  (d) Coordination With Privacy Regulations.--The Secretary 
shall implement and administer this section in a manner that is 
consistent with the implementation and administration by the 
Secretary of the regulations promulgated by the Secretary under 
part C of title XI of the Social Security Act (42 U.S.C. 1320d 
et seq.) and section 264 of the Health Insurance Portability 
and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).

           *       *       *       *       *       *       *


Part B--Individual Market Rules

           *       *       *       *       *       *       *


Subpart [3] 2--Other Requirements

           *       *       *       *       *       *       *


SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF GENETIC 
                    INFORMATION.

  (a) Prohibition on Genetic Information as a Condition of 
Eligibility.--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 (including information 
about a request for or receipt of genetic services by an 
individual or family member of such individual).
  (b) Prohibition on Genetic Information in Setting Premium 
Rates.--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 (including information about a request for or 
receipt of genetic services by an individual or family member 
of such individual).
  (c) Prohibition on Genetic Information as Preexisting 
Condition.--A health insurance issuer offering health insurance 
coverage in the individual market may not, on the basis of 
genetic information (including information about a request for 
or receipt of genetic services by an individual or family 
member of such individual), impose any preexisting condition 
exclusion (as defined in section 2701(b)(1)(A)) with respect to 
such coverage.
  (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) Certain rules of construction.--Nothing in this 
        part shall be construed to--
                  (A) limit the authority of a health care 
                professional who is providing health care 
                services with respect to an individual to 
                request that such individual or a family member 
                of such individual undergo a genetic test;
                  (B) limit the authority of a health care 
                professional who is employed by or affiliated 
                with a health insurance issuer and who is 
                providing health care services to an individual 
                as part of a bona fide wellness program to 
                notify such individual of the availability of a 
                genetic test or to provide information to such 
                individual regarding such genetic test; or
                  (C) authorize or permit a health care 
                professional to require that an individual 
                undergo a genetic test.
          (3) Rule of construction regarding payment.--
                  (A) In general.--Subject to subparagraph (B), 
                nothing in paragraph (1) shall be construed to 
                preclude a health insurance issuer offering 
                health insurance coverage in the individual 
                market from conditioning payment on obtaining 
                the results of a genetic test or informing 
                members of such policies. For purpose of the 
                preceding sentence, the term ``payment'' 
                includes reimbursement, billing, claims 
                management, claims adjudication, review of 
                health care services with respect to medical 
                necessity, coverage under a health plan, 
                appropriateness of care, or justification of 
                charges, and utilization review (including 
                precertification, prior authorization, 
                concurrent and retrospective review).
                  (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.
  (e) 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--
          (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.

                     Subpart 3--General Provisions

SEC. 2761. ENFORCEMENT.

  (a)  * * *
  [(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) 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.]
  (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.

           *       *       *       *       *       *       *


             Part C--Definitions; Miscellaneous Provisions

SEC. 2791. DEFINITIONS.

  (a)  * * *

           *       *       *       *       *       *       *

  (d) Other Definitions.--
          (1)  * * *

           *       *       *       *       *       *       *

          (15) Family member.--The term ``family member'' 
        means, with respect to any individual--
                  (A) a dependent (as such term is used for 
                purposes of section 2701(f)(2)) of such 
                individual; and
                  (B) any other individual who is a first-
                degree, second-degree, third-degree, or fourth-
                degree relative of such individual or of an 
                individual described in subparagraph (A).
          (16) Genetic information.--
                  (A) In general.--The term ``genetic 
                information'' means information about--
                          (i) an individual's genetic tests;
                          (ii) the genetic tests of family 
                        members of the individual; or
                          (iii) the occurrence of a disease or 
                        disorder in family members of the 
                        individual.
                  (B) Inclusion of genetic services and 
                participation in genetic research.--Such term 
                includes, with respect to any individual, any 
                request for genetic services, receipt of 
                genetic services, or participation in any 
                clinical research, or any other program, 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 an 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 (such as obtaining, 
                interpreting, or assessing genetic 
                information); or
                  (C) genetic education.
                              ----------                              


SOCIAL SECURITY ACT

           *       *       *       *       *       *       *


     TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
SIMPLIFICATION

           *       *       *       *       *       *       *


                 TITLE XVIII OF THE SOCIAL SECURITY ACT

Part E--Miscellaneous Provisions

           *       *       *       *       *       *       *


    CERTIFICATION OF MEDICARE SUPPLEMENTAL HEALTH INSURANCE POLICIES

  Sec. 1882. (a)  * * *

           *       *       *       *       *       *       *

  (o) The requirements of this subsection are as follows:
          (1)  * * *

           *       *       *       *       *       *       *

          (4) The issuer of the medicare supplemental policy 
        complies with subsection (s)(2)(E) and subsection (x).

           *       *       *       *       *       *       *

  (s)(1)  * * *
  (2)(A)  * * *

           *       *       *       *       *       *       *

  (E)(i) An issuer of a medicare supplemental policy shall not 
deny or condition the issuance or effectiveness of the policy, 
and shall not discriminate in the pricing of the policy 
(including the adjustment of premium rates) of an eligible 
individual on the basis of genetic information concerning the 
individual (or information about a request for, or the receipt 
of, genetic services by such individual or family member of 
such individual).
  (ii) For purposes of clause (i), the terms ``family member'', 
``genetic services'', and ``genetic information'' shall have 
the meanings given such terms in subsection (x).

           *       *       *       *       *       *       *

  (x) Limitations on Genetic Testing.--
          (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.--Nothing in this 
                title shall be construed to--
                          (i) limit the authority of a health 
                        care professional who is providing 
                        health care services with respect to an 
                        individual to request that such 
                        individual or a family member of such 
                        individual undergo a genetic test;
                          (ii) limit the authority of a health 
                        care professional who is employed by or 
                        affiliated with an issuer of a medicare 
                        supplemental policy and who is 
                        providing health care services to an 
                        individual as part of a bona fide 
                        wellness program to notify such 
                        individual of the availability of a 
                        genetic test or to provide information 
                        to such individual regarding such 
                        genetic test; or
                          (iii) authorize or permit a health 
                        care professional to require that an 
                        individual undergo a genetic test.
          (2) Definitions.--In this subsection:
                  (A) Family member.--The term ``family 
                member'' means with respect to an individual--
                          (i) the spouse of the individual;
                          (ii) a dependent child of the 
                        individual, including a child who is 
                        born to or placed for adoption with the 
                        individual; or
                          (iii) any other individuals related 
                        by blood to the individual or to the 
                        spouse or child described in clause (i) 
                        or (ii).
                  (B) Genetic information.--
                          (i) In general.--Except as provided 
                        in clause (ii), the term ``genetic 
                        information'' means information about--
                                  (I) an individual's genetic 
                                tests;
                                  (II) the genetic tests of 
                                family members of the 
                                individual; or
                                  (III) the occurrence of a 
                                disease or disorder in family 
                                members of the individual.
                          (ii) Exclusions.--The term ``genetic 
                        information'' shall not include 
                        information about the sex or age of an 
                        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 (such as 
                        obtaining, interpreting, or assessing 
                        genetic information); or
                          (iii) genetic education.
                  (E) 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.
  (y) Privacy and Confidentiality of Genetic Information.--
          (1) Compliance with certain confidentiality standards 
        with respect to genetic information.--
                  (A) In general.--The regulations promulgated 
                by the Secretary under part C of title XI of 
                the Social Security Act (42 U.S.C. 1320d et 
                seq.) and section 264 of the Health Insurance 
                Portability and Accountability Act of 1996 (42 
                U.S.C. 1320d-2 note) shall apply to the use or 
                disclosure of genetic information by an issuer 
                of a medicare supplemental policy.
                  (B) Prohibition on underwriting and premium 
                rating.--Notwithstanding subparagraph (A), an 
                issuer of a medicare supplemental policy shall 
                not use or disclose genetic information 
                (including information about a request for or a 
                receipt of genetic services by an individual or 
                family member of such individual) for purposes 
                of underwriting, determinations of eligibility 
                to enroll, premium rating, or the creation, 
                renewal or replacement of a plan, contract or 
                coverage for health insurance or health 
                benefits in connection with such policy.
          (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 (including 
                information about a request for or a receipt of 
                genetic services by an individual or family 
                member of such individual) for purposes of 
                underwriting, determinations of eligibility to 
                enroll, premium rating, or the creation, 
                renewal or replacement of a plan, contract or 
                coverage for health insurance or health 
                benefits in connection with such policy.
                  (B) Limitation relating to the collection of 
                genetic information prior to enrollment.--An 
                issuer of a medicare supplemental policy shall 
                not request, require, or purchase genetic 
                information (including information about a 
                request for or a receipt of genetic services by 
                an individual or family member of such 
                individual) concerning an enrollee prior to the 
                enrollment, and in connection with such 
                enrollment, of such individual under the 
                policy.
                  (C) Incidental collection.--Where the issuer 
                of a medicare supplemental policy obtains 
                genetic information incidental to the 
                requesting, requiring, or purchasing of other 
                information concerning an enrollee in 
                connection with such a policy, such request, 
                requirement, or purchase shall not be 
                considered a violation of this paragraph if--
                          (i) such request, requirement, or 
                        purchase is not in violation of 
                        subparagraph (A); and
                          (ii) any genetic information 
                        (including information about a request 
                        for or receipt of genetic services) 
                        requested, required, or purchased is 
                        not used or disclosed in violation of 
                        paragraph (1).
          (3) Application of confidentiality standards.--The 
        provisions of paragraphs (1) and (2) shall not apply--
                  (A) to health insurance issuers that are not 
                otherwise covered under the regulations 
                promulgated by the Secretary under part C of 
                title XI of the Social Security Act (42 U.S.C. 
                1320d et seq.) and section 264 of the Health 
                Insurance Portability and Accountability Act of 
                1996 (42 U.S.C. 1320d-2 note); and
                  (B) to genetic information that is not 
                considered to be individually-identifiable 
                health information under the regulations 
                promulgated by the Secretary under part C of 
                title XI of the Social Security Act (42 U.S.C. 
                1320d et seq.) and section 264 of the Health 
                Insurance Portability and Accountability Act of 
                1996 (42 U.S.C. 1320d-2 note).
          (4) Coordination with privacy regulations.--The 
        Secretary shall implement and administer this 
        subsection in a manner that is consistent with the 
        implementation and administration by the Secretary of 
        the regulations promulgated by the Secretary under part 
        C of title XI of the Social Security Act (42 U.S.C. 
        1320d et seq.) and section 264 of the Health Insurance 
        Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note).

           *       *       *       *       *       *       *


                            ADDITIONAL VIEWS

    Although the Committee has made important improvements to 
H.R. 493, the ``Genetic Information Non-Discrimination Act'' 
(GINA), we believe it is imperative that all parties continue 
to work to improve this legislation and address the issues we 
raise in these additional views. We believe there are 
significant technical problems with the legislation in its 
current form. We respect the changes and the work of the 
Committee in the short period of time from the hearing to full 
committee markup. We note the inclusion of information on 
embryos, fetuses, and adopted children; a clear statement that 
Title II does not apply to group health plans and insurers; a 
clear statement that nothing affects claims processing and 
related items; and, an exemption from the unworkable Title II 
mandates for entities already subject to regulations governing 
personally identifiable health information. Among other things 
we believe these changes should be consistent with group health 
plans and health insurance issuers providing information to 
providers or individuals about genetic tests for coverage and 
benefits, treatment alternatives, disease management, case 
management, patient care management, care coordination and 
prevention programs. These programs are today improving the 
quality of health care and nothing in this bill should 
undermine such efforts. These are solid steps in the right 
direction,
    The primary author of the House bill, Ms. Slaughter, has 
stated:

          GINA prohibits group health plans and health insurers 
        from denying coverage to a healthy individual or 
        charging that person higher premiums based solely on a 
        genetic predisposition to develop a disease in the 
        future. Furthermore, it bars employers from using an 
        individual's genetic information when making hiring, 
        firing, job placement or promotion decisions.

    We want to focus the legislation on these objectives and 
not go beyond them. The drafting simply does not match, or at 
least is not tailored to, the statement of the primary sponsor. 
The legislation, in its current form, will needlessly disrupt 
and hinder positive activities and policies for employers, 
insurers and health care. These are not easy issues. The 
protagonists of GINA have delved into some sweeping and 
difficult arenas: the ability to define and segregate ``genetic 
information'' from other medical information, new permutations 
of civil rights laws, new restrictions on health information, 
occupational safety issues, and Federal-State relations are 
among them. We think the suggestions we make below could be 
very helpful.

 The New Regulatory Regime in Title II for the Delivery of Health Care 
 and Related Services That May Be Offered by or Sponsored by Employers 
                            is Inappropriate

               CONCERNS REGARDING DELIVERY OF HEALTH CARE

    Title III of GINA would launch a new health information 
regulatory scheme that would be administered out of the Equal 
Employment Opportunities Commission. Our understanding is this 
scheme would cover, in part, the communications of certain 
health care providers or companies providing electronic health 
record services. Specifically, if an employer is providing a 
health service or electronic record service, the provisions of 
Title II of GINA attach. Providing a service includes both in-
house employees and contracts with other entities.
    We fail to see why covering the delivery of health care and 
health services in Title II has anything to do with hiring, 
firing, job placement or promotion decisions. People delivering 
health care and health services are not hiring or firing 
people. Health information, including genetic information is 
critical to the delivery of care. If a company is providing a 
personal health record service it is technically problematic 
and detrimental to the patient to sanitize information like 
family medical history or other genetic information.
    Here are the potential problems:
    1. GINA provides that the medical decisions of certain 
health care providers in using genetic information can be a 
basis for a civil rights violation. That means the practice of 
medicine may be subject to claims of discrimination, even 
though they have nothing to do with hiring, firing, job 
placement or promotion.
    2. Under section 202(b), 202(c) and 206(b) the 
communications in the process of health services are restricted 
well above what is appropriate under the extensive privacy 
regulations governed by the Department of Health and Human 
Services.
    3. These restrictions will inhibit the coordination of care 
among health providers, slow down processing and care because 
of the need to evaluate each document to sanitize or specially 
handle information, and increase medical errors.
    4. These restrictions will essentially make employer 
participation in electronic health record services and personal 
health record services extremely burdensome. Indeed, 
contracting with a company to provide such services for 
employees is covered under the information restrictions of 
Title II.
    5. This health information regulatory regime would be 
inconsistent with the regime run by the Department of Health 
and Human Services.
    We should not penalize the good that employers can do for 
their employees by providing health care services or electronic 
health record services. Sponsorship of the delivery of health 
care by an employer is not hiring, firing, job placement or 
promotion. And genetic information is important to the delivery 
of health care. We believe nothing in Title II should apply to 
the actions or communication respecting the delivery, 
administration, or operation of health care including any 
health services, pharmacies, health records services, health 
counseling, or health education. We also believe that nothing 
in either title should regulate actions or communications 
respecting the practice of medicine including but not limited 
to diagnosis, treatment, counseling and education. These 
activities clearly fall outside the scope of the author of 
GINA's stated intent. We would like to work with all parties 
and craft language that makes these points clear.
    We are pleased at the amendments in Full Committee that 
would exempt covered entities within the meaning of the Health 
Insurance Portability and Accountability Act (HIPAA) Privacy 
Rule from the unworkable mandates of Title II. This helps with 
respect to the concerns we raise in a number of instances, but 
not in others.
    We have heard specific concerns regarding the application 
of sections 202(b) and 206(b) and the broad definitions and 
prohibitions as they might restrict or delay further adoption 
of electronic health records and personal health records.
    We note that the exclusion for HIPAA covered entities is 
helpful but will not fully address the issues. We fear these 
points are just the tip of the iceberg. We see no reason that 
the delivery of health care should be regulated or restricted 
by Title II. These issues have nothing to do with Ms. 
Slaughter's stated purpose concerning making hiring, firing, 
job placement or promotion decisions. However, the current bill 
could drastically impede a much shared goal to transform our 
health care system through utilization of electronic health 
records.

The Information Regulations in Title II Are Overly Broad and Unworkable

                    A SWEEPING NEW REGULATORY SCHEME

    Title II has sweeping breadth. It covers employers from the 
FBI to NASA to laboratories, to State and local governments, to 
nuclear power plants, to hospitals, and many more. Title II 
restricts information flow in numerous settings from employers 
involved in responses to pandemic flu outbreaks, to employers 
involved in judicial proceedings, to health and safety 
monitoring, and to employers administering or sponsoring 
benefits. We cannot today easily imagine all of the 
circumstances. The HIPAA Privacy Rule gives us a clue to this 
complexity. It is a complex series of extensively debated 
exceptions to prohibited uses and disclosures of information. 
The proposed rule received over 50,000 comments and the next 
proposed set of modifications received over 11,000 comments. 
Among other things, this draft document will point out below 
how section 202(b) and 206 and other provisions of GINA fail to 
include the numerous exclusions for use and disclosure that HHS 
had to address in the Privacy Rule. The Americans with 
Disabilities Act also has information regulations with respect 
to disability related inquiries and medical examinations. 
Rather than use the knowledge from either of these two models, 
GINA strikes out on a third, unworkable scheme. The biggest 
problem is that subsections like 202(b), 203(b), 204(b) and 
206(b) start with sweeping prohibitions on either acquisition 
or disclosure of information. These subsections then follow 
with exactly five specific exemptions. Note that these 
exemptions are not even coextensive between subsections 202(b) 
and 206(b).
    Based on this statutory structure, it may be impossible for 
the Equal Employment Opportunities Commission to argue that it 
could add to the list of statutory exemptions. Accordingly, the 
authors of GINA must assume Congress has contemplated all 
reasonable circumstances for acquisition and disclosure by 
employers or sponsored activities and set them out in the 
exemptions. Although the Privacy Rule starts out withbans on 
use and disclosure, there are dozens of important exceptions. For 
example, if you were to work with a contract organization to manage 
records, that would fall under the business associate provisions of the 
rule. Even disclosures for civil and criminal litigation, law 
enforcement, to heirs of decedents, for serious threats to health and 
safety, essential government functions, incidental uses, workers 
compensation, treatment, payment, health care operations all have 
specific exceptions. These exceptions are not in GINA. We are not 
saying all of the Privacy Rule map perfectly to the employer context. 
(We are saying that for delivery of health care). However, many of the 
Privacy Rule's permitted uses and disclosures include normal and 
routine uses and disclosures, including those important for the public 
good. These would seem to make sense and be necessary within the 
context of GINA.

         EXAMPLES IN THE LAW ENFORCEMENT AND JUDICIAL SETTINGS

    Moreover, even where GINA has exemptions they are not 
always logical. Consider this concern voiced in technical 
assistance from the FBI:

          Section 206, subpart (b)(3), permits an employer to 
        provide genetic information concerning an employee or a 
        request by the employee for genetic services in 
        response to a court order ONLY after providing notice 
        to the employee of the court order and permitting the 
        employee to challenge the order. It doesn't distinguish 
        between civil cases and criminal cases, or those 
        situations in which the court order may require that 
        the recipient not disclose the order. The section also 
        does not describe how the recipient employer is 
        supposed to handle notice if the employee no longer 
        works for their company, or has moved from their last 
        address known to the employer, or has died.

    These are valid considerations. In fact, we are wondering 
why GINA would in any way suggest anything other than full 
compliance with a court order. And why would GINA impose a duty 
of notice concerning such an order to an employer. Notice to 
the employee to challenge any order should come through the 
court.
    In fact, when compared with GINA, the HIPAA Privacy Rule 
permits disclosures pursuant to warrants, subpoenas and 
administrative orders. GINA does not. Is GINA forbidding 
response to such orders? The Privacy Rule would allow a covered 
entity to respond to the request of law enforcement officials 
for blood type information. As discussed below, blood typing 
seems to ``detect a genotype'' within the meaning of the GINA 
definitions. Why should GINA be more restrictive with respect 
to law enforcement and judicial proceedings that the current 
HIPAA regulations?
    Some employers use DNA identification tests, which appear 
to be covered by the GINA definitions. For example, labs and 
some policy enforcement organizations may take DNA samples to 
help unravel contamination issues at labs or crime scenes. Some 
employers provide for medical monitoring programs to protect 
against injuries to employees. We received the following 
technical assistance from FBI:

          Section 201. Recommend narrowing the definition of 
        ``genetic test'' to the following, and to strike the 
        subsection on Exceptions:
          The term ``genetic test'' means--the analysis of 
        human DNA, RNA, chromosomes, proteins, or certain 
        metabolites in order to detect disease-related 
        genotypes or related phenotypes. The term does not 
        apply to any such testing which is conducted for the 
        exclusive purposes of identification, where no 
        information regarding the sample is to be provided to 
        any entity for the purposes of determining any health 
        related information regarding either the individual or 
        members of the individual's family.

    We received this point as technical assistance from staff 
in the Bureau of Alcohol, Tobacco, and Firearms (ATF):

          ``. . . . Please let me know if there is anything we 
        in the forensic DNA community can do to aid in the 
        modification of this bill so it will not have the 
        unintentional effects that it may have as written. I 
        have outlined my concerns below. . . .

          Forensic DNA technology has progressed to the point 
        that it is possible to obtain a DNA profile from 
        handled objects or even a fingerprint. Because of this, 
        most forensic DNA labs have created a staff DNA index. 
        Any DNA profiles developed from evidence are then 
        compared to the staff index. This accomplishes two 
        things. First, if the DNA profile developed from the 
        evidence is actually from an investigator or laboratory 
        person and not the true perpetrator, a false exclusion 
        might be made. Second, unknown profiles developed from 
        evidence are typically uploaded to the Combined DNA 
        Index System (CODIS). If the investigator's profile or 
        laboratory scientist's profile is not caught through 
        the use of a staff index, the profile would be uploaded 
        to CODIS. If it happens again, two unrelated crimes 
        could subsequently linked that are not truly linked.''

    We received this point as technical assistance from the 
staff of the Veterans Administration:

          This section does not authorize disclosure in 
        administrative or court proceedings in which the 
        employee has either placed the genetic condition at 
        issue or raised a claim for which the information is 
        clearly relevant. It would appear that VA, as an 
        employer, could not provide the records to an 
        administrative entity upon its request or order without 
        first obtaining a Federal court order to produce the 
        information.

            EXAMPLES FOR HEALTH AND SAFETY MONITORING ISSUES

    Beyond these judicial and law enforcement issues are safety 
issues:
    Mr. Deal asked the witness from the EEOC the following 
question:

          We want your interpretation of section 202(b)(5)(B). 
        Assume that genetic monitoring is not required by 
        Federal or state law. The business nonetheless feels 
        that safety requires such monitoring. If the employee 
        says he does not want to be subject to such monitoring, 
        does the employer still have the right to reassign him 
        away from the position that needed the monitoring? Or 
        must the employer allow the employee to continue 
        without the monitoring?

    Our understanding is the EEOC witness stated that 
reassigning an employee who refuses to provide information for 
monitoring described above would be subject to a claim of an 
illegal employer practice under GINA. This is a problem. Why 
would we take away from employers the ability to demand 
monitoring for worker safety?
    We further note that the definition of acceptable genetic 
monitoring is only in the context of exposure at the work 
place. If an employer is monitoring for infectious diseases to 
protect public safety, such monitoring does not seem to have an 
exception to allow consideration of genetic information in that 
context.

                      WAYS TO REDUCE THE PROBLEMS

    All of the above pieces of technical assistance, letters, 
or testimony identify unexpected problems with the prohibitions 
on acquisition and disclosure. We believe these are just the 
tip of the iceberg. The EEOC has provided some technical 
assistance that might provide for regulatory authority to 
create additional exemptions. In addition, employer 
stakeholders have been asking Congress to not use language like 
that in subsections 202(b) or 206(b). Employers note the model 
under the Americans with Disabilities Act is familiar to them 
and more workable. It seems entirely possible to use language 
similar to that under the ADA provisions to make this law 
consistent. Until there are changes to these sections, GINA 
poses many counterproductive results. We would like to work 
with all parties to eliminate these counterproductive results.

GINA Contains Inconsistent, Overly Broad and Unworkable Definitions of 
                  Genetic Test and Genetic Information

    The terms genetic test and genetic information are overly 
broad in GINA. The definitions are inconsistent between titles 
and not matched to the policy purpose. Forty-three states have 
definitions. None of the state definitions are as broad or as 
unworkable as the definitions in GINA. GINA simply includes 
information well beyond tests intended to find a predictive 
genetic marker for a genetic disease. Title II of GINA covers 
blood typing, tissue typing, cancer tumor typing, DNA forensic 
information, genotypic information useful to reduce adverse 
reactions to treatments and therapies, and more. The definition 
of genetic information includes ``the occurrence of a disease 
in a family member''--even when not used for predictive 
purposes.
    Apparently, if we were to ask one of our staff how one of 
their children were doing with the flu or other disease, we 
would be requesting genetic information within the meaning of 
GINA. Apparently, if an employer is testing for drugs but that 
test also detects the blood type AB in an employee, that test 
detected a genotype and would besubject to the sanctions of 
this bill.
    It is not alright to subject employers to vague and 
unworkable standards and levy the threat of sanctions for civil 
rights violations against them. The current language of this 
bill could have serious negative consequences to both the 
individual and public health by saddling health and safety 
monitoring, electronic health information systems, health care 
providers, emergency preparedness efforts, claims processing 
for workers compensation and many other items with the burden 
of separating legitimate medical information into two file 
folders.
    As Dr. Francis Collins testified, genetic information is 
basically medical information. To treat it under a separate 
regulatory regime for items such as medical monitoring for 
employee safety or employee sponsored health services will 
remove vital information for vital purposes. This will create 
medical errors and needless bureaucracy.

  PROBLEMS WITH THE SWEEP OF INCLUDING THE OCCURRENCE OF A DISEASE OR 
 DISORDER IN FAMILY MEMBERS WITHOUT FURTHER LIMITATION OR CLARIFICATION

    On the point concerning ``the occurrence of a disease or 
disorder in a family member'', under subsection 202(b) an 
employer may not request or require such information, unless 
pursuant to a specific exception. We realize that the 
occurrence of a disease or disorder could be part of a scheme 
to forecast a genetic disease in an employee. It is also useful 
information for many other purposes. We believe that the basic 
intent of the authors is to regulate a predictive assessment 
concerning an individual's propensity to get an inheritable 
genetic disease or disorder based on the occurrence of an 
inheritable genetic disease or disorder in the family member. 
After all, if an employer or insurer is not trying to make such 
a predictive assessment, they really are not within the scope 
of the policy purpose of the bill. By using the broader 
universe of information concerning ``a disease or disorder in a 
family member'' GINA opens up an incredible range of 
workability problems. Note that ``a disease or disorder'' does 
not have to be a genetic disease or disorder. It could just be 
a cold or a disease that came from poisoning.
    If an employer sponsors a benefit for an employee to raise 
money for the employee's child's illness that employer seems to 
have violated both subsection 202(b) and 206(b). What if an 
employer wants information from an employee as back up for a 
worker absence that is not pursuant to the Family Medical Leave 
Act? What happens if an employer employs several family 
members. Does the ``occurrence of a disease or disorder'' 
language apply to each employee? If so, would record keeping on 
employee absences not be acceptable.
    What if there are issues about infectious diseases? Under 
the National Pandemic Flu Preparedness Plan, employers would 
play a key role in information dissemination and assessment of 
the spread of the disease. There are no exceptions for such 
emergencies under GINA.
    All of these problems would be unnecessary if the language 
were restricted to a predictive assessment concerning an 
individual's propensity to get an inheritable genetic disease 
or disorder based on the occurrence of an inheritable genetic 
disease or disorder in the family member.

                NUMEROUS INCONSISTENCIES WITHIN THE BILL

    On the definition of genetic test, we point out that the 
definitions are, for no apparent reason, different in Title I 
and Title II. In conjunction with this we note the treatment of 
manifested diseases and how they affect regulation are also 
different in Title I and Title II for no apparent reason. We 
further note that the treatment of tests which identify 
genotype, mutation, or chromosomal changes, based on protein or 
metabolite analysis in the context of manifested diseases are 
excluded under Title I. Yet a test which identifies the same 
things based on DNA or chromosome analyses are not excluded for 
purposes of Title I. There is no manifested disease exclusion 
in the definitions in Title II. This means some tests that can 
type a cancer tumor fall into one regulatory category and 
others do not. And this is all just in one bill. Please 
understand this bill will partially override 43 State 
definitions of genetic tests and genetic information creating 
maximum confusion.

  FAILURE TO LIMIT DEFINITION TO GENETIC MARKERS FOR GENETIC DISEASES

    Under GINA, the term `genetic test' means an analysis of 
human DNA, RNA, chromosomes, proteins, or metabolites that 
detects genotypes, mutations, or chromosomal changes. Francis 
Collins, head of the National Human Genome Research Institute 
said the GINA reference to detecting a genotype covered, among 
other things, tests to look at genetic profiles to select safer 
drugs, forensic DNA identification tests, tissue typing for 
organ donation; and paternity tests. He stated that the fact 
that someone has an O or AB blood type also detects that person 
has the O or AB genotype. He also made clear that certain DNA 
tests for tumor typing of cancer are covered by the definition. 
He further stated that the phrase ``occurrence of a disease or 
disorder in family members of the individual'' was not limited 
to inheritable genetic disease and that this might include 
infectious or contagious diseases of family members. We have 
tried to review definitions of genetic information or test 
under state laws. None of them have the breadth of the GINA 
definitions.
    As confirmed by Committee Counsel during the markup we do 
not read any requirement that the detection of ``genotypes'' 
within this paragraph is limited to genotypes related to 
genetic diseases, disorders or pathological conditions. Our 
further concern is that more and more clinical diagnostics will 
``detect a genotype'' in at least one part of the analysis. 
This may be true even if it is not the purpose of the test to 
look for genetic markers for disease. It may also be true if 
the basic purpose of the test is not to look for a blood type. 
Yet if the test detects a blood type, it would appear to be 
covered by the GINA definitions. This means a tremendous level 
of basic information is not defined as a genetic test or 
genetic information well beyond the core purposes of the bill.
    We remain unclear on how tests for the effects of viruses 
or pathogens might fit in to GINA. Some types of viruses 
actually physically insert their genes into the host's genome 
(it is the defining feature of retroviruses, the family of 
viruses that includes HIV, the virus that causes AIDS). This 
incorporates the genes of that virus among the genes of the 
host cell for the life span of that cell. Beyond this some 
viruses, such as the Hepatitis C virus, also add material to 
human chromosomes or DNA.
    We believe there may be analyses of human DNA, RNA, 
chromosomes, proteins, or metabolites that provide direct 
evidence of retroviruses or other viruses. These analyses may 
be construed to detect a human chromosomal change or mutation. 
We recognize the insertion into the human chromosome or 
mutation to DNA is, in part, an insertion of viral DNA. There 
nonetheless appears to be a change in the sequence of the human 
DNA, genotype or chromosome. We want to know whether the phrase 
``detects a genotype, mutation, chromosomal change'' could 
refer to such mutations and chromosomal changes in humans 
caused by such viruses. If it can we have further concerns 
about the effect of this legislation with respect to health and 
safety monitoring and employer precautions.
    Again, Ms. Slaughter's stated concern was discrimination 
``based solely on a genetic predisposition to develop a disease 
in the future.'' This would be consistent with the language in 
Executive Order 13145 which was limited to tests done ``in 
order to detect disease-related genotypes or mutations.'' In 
the 108th Congress, Ms. Slaughter's bill exempted from the 
definition of protected genetic information any ``information 
about physical exams of the individual and other information 
that indicates the current health status of the individual.'' 
This is a very useful exception. It's just not in GINA. We keep 
asking, what do DNA forensic evidence, blood typing, tissue 
typing, cancer tumor typing, or pharmacogenomics have to do 
with predicting a genetic disease?
    The downsides of the inconsistent and overly broad 
definitions are many. Employers and employer sponsored benefit 
programs will have several information regimes for medical 
information. GINA force separation of such information which 
will be a bureaucratic nightmare, lead to medical errors, 
create inconsistencies in communications with providers, limit 
medical monitoring, create confusion in law enforcement and 
judicial functions. If important information related to viruses 
or contagious diseases are also covered, we may be compromising 
the ability of an employer to help in public safety efforts or 
to protect the public's health and safety. We would not want to 
see medical monitoring for infectious diseases precluded from 
an employers tool box for instances where public health and 
safety is at stake.
    The discouraging part of this is that the 43 states that 
have definitions do not have these problems. They all limit 
regulations to genetic markers that predispose toward a future 
disease. Many specifically refer to inherited genetic material. 
Many have specific exceptions for items like HIV testing or 
drug and alcohol tests. Despite these problems we have been met 
with a seeming unwillingness from the protagonists to address 
any of these issues. We hope that is not the case.

 GINA Will Create Confusion for the 43 States That Currently Have Laws 
        Prohibiting Discrimination Based on Genetic Information

    We have not done a complete survey but understand that 43 
States already have programs and definitions. We would then 
want to ask Members if they find the programs in their state 
inadequate. If you were to superimpose the GINA requirements on 
those states it will involve a lot of confusion. Many 
exemptions and clear statements regarding HIV testing, drug 
testing, and other issues would appear to be wiped out. Even 
more frustrating for the regulatory community the operative 
Federal-state relationship rule is whatever part of a state law 
is more stringent survives. This means pieces of state law will 
apply while other pieces will be preempted. This would all have 
to be sorted out by the courts. We think there are better 
approaches. The worst approach is this partial preemption 
approach. For some programs there is across the board 
preemption. In other cases, a state is allowed to submit its 
program for evaluation as a whole. If such programs are 
adequate or substantially promoting the policy, they would stay 
intact. We believe our States are substantially meeting the 
policy and do not see the need for disruption. In any event, 
some Federal agency should at least sort out what law applies 
in advance so that the regulated community is not held hostage 
to more lawyers and uncertainty.

                                   Joe Barton.
                                   Nathan Deal.
                                   Michael Burgess.
                                   Steve Buyer.
                                   Barbara Cubin.
                                   Mike Rogers.
                                   John Shadegg.
                                   Cliff Stearns.
                                   Lee Terry.
                                   Heather Wilson.
                                   Tim Murphy.

                                  
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