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                                                        Calendar No. 97
110th Congress                                                   Report
                                 SENATE
 1st Session                                                     110-48

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



 
           GENETIC INFORMATION NONDISCRIMINATION ACT OF 2007

                                _______
                                

                 April 10, 2007.--Ordered to be printed

                                _______
                                

   Mr. Kennedy, from the Committee on Health, Education, Labor, and 
                   Pensions, submitted the following

                              R E P O R T

                         [To accompany S. 358]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (S. 358) to prohibit discrimination 
on the basis of genetic information with respect to health 
insurance and employment, having considered the same, reports 
favorably thereon with an amendment in the nature of a 
substitute and recommends that the bill (as amended) do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and summary of the legislation...........................1
 II. Background and need for legislation..............................5
III. Legislative history and votes in committee......................12
 IV. Explanation of bill and committee views.........................16
  V. Cost estimate...................................................33
 VI. Application of law to the legislative branch....................35
VII. Regulatory impact statement.....................................35
VIII.Section-by-section analysis.....................................36

 IX. Changes in existing law.........................................46

               I. Purpose and Summary of the Legislation

    The purpose of this legislation is 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. These steps are essential 
to fulfilling the promise of the human genome project.

                       Title I--Health Insurance

    The legislation applies to employer-sponsored group health 
plans, health insurance issuers in the group and individual 
markets, Medigap insurance, and State and local non-Federal 
governmental plans.

                           NONDISCRIMINATION

    Group Health Plan Protections: The Employee Retirement and 
Security Act (ERISA) currently prohibits a group health plan or 
health insurance issuer offering coverage in connection with a 
group health plan from discriminating against an individual in 
the group in setting eligibility or premium or contribution 
amounts based on the individual's genetic information. This 
legislation clarifies that genetic information includes 
``information about a request for or a receipt of genetic 
services by an individual or family member of such 
individual.'' It also prohibits a health insurance issuer 
offering 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.
    Individual Health Insurance Market Protections: This 
legislation prohibits health insurance issuers in the 
individual market from using genetic information about 
enrollees or their family members to adjust premium or 
contribution amounts, using genetic information as a condition 
of eligibility for insurance coverage.
    Medicare Supplemental Protections: This legislation 
prohibits an issuer of a Medicare supplemental policy from 
denying or conditioning the issuance of a policy, or 
discriminating in the price of the policy, based on genetic 
information.

                     LIMITATION ON GENETIC TESTING

    Group health plans, health insurance issuers in the group 
and individual market, and issuers of Medicare supplemental 
policies covered under this title are prohibited from 
requesting or requiring an individual to take a genetic test. 
However, the legislation makes it clear that this provision 
does not interfere with the delivery of health care services. 
For instance, this provision does not limit the authority of 
the treating health care professional to request that an 
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 a health plan or issuer from 
notifying an individual about genetic tests or providing 
information about a genetic test if such actions are carried 
out as part of a wellness program. However, the legislation 
does prohibit a health care professional from requiring that an 
individual undergo a genetic test.

           PRIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION

    The HHS Standards for Privacy of Individually Identifiable 
Health Information (medical privacy regulations) (45 CFR Parts 
160 and 164; final rule) already protect the use and disclosure 
of all individually identifiable health information, including 
genetic information. However, a permitted ``use'' of health 
information under the privacy rules (i.e., a specific item 
under ``health care operations'') is underwriting, a practice 
that is inherently discriminatory. Therefore, this bill 
expressly bans the use or disclosure of genetic information for 
purposes of underwriting. In addition, this bill bans health 
plans and insurance issuers from collecting (i.e., requesting 
or requiring) genetic information in the first place for 
purposes of underwriting.
    In addition, this bill further protects the privacy of 
genetic information by prohibiting plans and insurance issuers 
from collecting (i.e., requesting, requiring, or purchasing) 
genetic information prior to enrollment under the plan.

                              ENFORCEMENT

    By building these protections into existing statutes (e.g., 
ERISA PHSA, and the Social Security Act), this title generally 
uses the same mechanisms to enforce the protections established 
under this legislation as apply to other violations of these 
underlying statutes. In addition, this legislation ensures that 
similarly situated individuals are provided the same protection 
under the law, regardless of whether they are currently sick or 
disabled, or currently healthy. All individuals (healthy and 
sick) have genetic information that could be used to 
discriminate against them.
    With respect to the nondiscrimination requirements, this 
legislation is based on the same penalty and enforcement 
structure as Title I of HIPAA, which addresses insurance 
portability and discrimination based on health status. In 
general, under ERISA, group health plan participants or the 
Department of Labor can sue for relief under ERISA. This 
legislation further clarifies that with respect to a group 
health plan, a participant or beneficiary has the right to seek 
injunctive relief before exhausting administrative remedies if 
taking the time to pursue administrative remedies would cause 
irreparable harm to the participant's health. Where a 
participant or beneficiary obtains relief under ERISA for a 
genetic discrimination violation, the court has the discretion 
to reinstate coverage, retroactive to the date of violation and 
can award a penalty to the participant. The penalty amount 
payable to the individual is the same as the primary penalty 
that may be assessed by the Secretary under current law 
enforcement.
    For group health plans and health insurance issuers in the 
individual and group markets, the appropriate Secretary may 
impose penalties of $100 per day/per person, with a minimum 
penalty of $2,500--up to $15,000 for multiple violations that 
are more than de minimis with an outside cap of up to $500,000 
for a violation of the protections against genetic 
discrimination.
    With regard to the privacy provisions established by this 
legislation, the same enforcement structure and penalties 
created by the Social Security Act for the HHS privacy 
standards apply with regard to the privacy protections 
established for genetic information by this legislation. Under 
this legislation, the genetic privacy provisions are enforced 
by the HHS Office of Civil Rights. The Secretary of HHS may 
impose civil monetary penalties of $100 per violation--up to 
$250,000 and 10 years in prison for violations committed for 
commercial advantage, personal gain, or malicious harm.

                    Title II--Employment Provisions


                     PROHIBITION ON DISCRIMINATION

    The legislation prohibits the use of genetic information in 
employment decisions, such as hiring, firing, job assignments, 
and promotions. This prohibition extends to employers, unions, 
employment agencies, and labor-management training programs.

                       LIMITATION ON ACQUISITION

    Employers, labor organizations, employment agencies, and 
joint labor-management committees are prohibited from 
requesting, requiring, or purchasing genetic information about 
an employee or family member, except for the following 
legitimate reasons: (1) for genetic monitoring of biological 
effects of toxic substances in the workplace, (2) if the 
employer provides genetic services, such as through a wellness 
program, with the employee's prior consent, or (3) for 
compliance with the certification provision of the Family and 
Medical Leave Act or its State equivalent. The purchase of 
commercially and publicly available documents (except medical 
databases or court records) or inadvertently requesting or 
requiring family medical history would not violate this title. 
Under each of these exceptions, however, the genetic 
information still could not be used or disclosed.

                      CONFIDENTIALITY PROTECTIONS

    The legislation safeguards the confidentiality of genetic 
information in the employment setting. If an employer (acting 
as an employer) acquires genetic information, such information 
shall be treated and maintained as part of the employee's 
confidential medical records. Moreover, such information shall 
not be disclosed except in limited situations, such as to the 
individual or in order to comply with the certification 
provisions of Federal or State family and medical leave laws, 
or a court order.

                              ENFORCEMENT

    The legislation protects applicants or employees of 
employers defined under the Civil Rights Act of 1964 (42 U.S.C. 
2000e(f)), State employees, Federal employees, congressional 
employees, and employees as defined in 3 U.S.C. 411(c). 
Claimants are required to file a charge with the appropriate 
enforcement agency within a certain time period, prior to 
filing a suit in court. The bill provides for the same 
compensatory and punitive damages available to prevailing 
plaintiffs under 42 U.S.C. 1981a, which are progressive with 
the size of the employer and limited to cases of disparate 
treatment.

                            DISPARATE IMPACT

    The bill prohibits claims based on disparate impact and 
empanels a commission in 6 years to review the science and law 
of genetics. The purpose of the Commission is to review the 
science of genetics and advise the Congress on the necessity of 
providing for a disparate impact cause of action in the future.

            DEFINITIONS--(GENERALLY APPLY TO TITLE I AND II)

    Genetic information is defined to include 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. Genetic 
information does not include information about the sex or age 
of an individual for purposes of this legislation.
    A genetic test is defined as an analysis of DNA, RNA, 
chromosomes, proteins, or metabolites, that detects genotypes, 
mutations, or chromosomal changes. A genetic test does not mean 
an analysis of (1) proteins or metabolites that does not detect 
genotypes, mutations, or chromosomal changes or; (2) 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. The second exception to genetic test only applies to 
title I of the legislation.
    Genetic Services is defined as a genetic test; genetic 
counseling (such as obtaining, interpreting, or assessing 
genetic information), or genetic education.

                II. Background and Need for Legislation


                      SEQUENCING THE HUMAN GENOME

    Only rarely is a scientific discovery so significant that 
it has the potential to transform both science and society. 
Humanity's newly acquired ability to map and understand its own 
genetic traits may well be one such transforming discovery. 
While recent advances in genetics are the work of thousands of 
scientists in dozens of countries, the most prominent symbol of 
our newfound understanding of genetics was the announcement in 
April 2003 that a vast team of scientists had determined the 
exact sequence of the human genetic code and placed that 
information in public databases.
    The most immediate use of the data from sequencing the 
genome will be to increase our understanding of the links 
between genes and disease. Medicine has already benefited from 
the first trickle of what will eventually become a flood of new 
discoveries about the links between genetic mutations and 
particular diseases. One well-known example of such a link is 
the correlation between mutations in two genes, BRCA1 and 
BRCA2, and an elevated risk of breast and ovarian cancer. When 
used to guide medical decision-making, a test for a mutation in 
one of the two BRCA genes can be of considerable benefit to 
women in evaluating their risk of disease and in taking steps 
to reduce that risk.
    Yet this new understanding of the genetic basis of disease 
holds dangers as well as opportunities. Although the knowledge 
that a person carries a mutation in a disease-related gene may 
be used to inform future medical treatment or as a stimulus to 
seek preventive care, that same knowledge could also be used 
for harmful purposes. A health insurance company might wrongly 
view the presence of the 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. 
An employer might use information about an employee's genetic 
profile to deny employment to an individual who is healthy and 
able to do the job. In several hearings on this issue, the 
committee heard that many non-specialists regard the presence 
of a genetic mutation as an unalterable prediction that a 
person will manifest the disorder associated with that 
mutation, rather than simply one of many factors affecting 
health.\1\
---------------------------------------------------------------------------
    \1\ For example, testimony of Francis Collins (HELP Committee 
hearing, July 25, 2001) and Kathleen Zietz (HELP Committee hearing, 
July 25, 2001).
---------------------------------------------------------------------------
    With these misconceptions so prevalent, employers may come 
to rely on genetic testing to ``weed out'' those employees who 
carry genes associated with diseases. Similarly, genetic traits 
may come to be used by health insurance companies to deny 
coverage to those who are seen as ``bad genetic risks.'' 
Enabling employers, health insurers and others to base 
decisions about individuals on the characteristics that are 
assumed to be their genetic destiny would be an undesirable 
outcome of our national investment in genetic research, and may 
significantly diminish the benefits that this research offers.

              CONCERNS ABOUT MISUSE OF GENETIC INFORMATION

    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. However, 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.\2\ Such fears also extend to clinical 
practice, discouraging both patients and providers from taking 
full advantage of genetic tests and technologies.
---------------------------------------------------------------------------
    \2\ For example, testimony of Ms. Kathleen Zeitz (HELP Committee 
hearing, July 25, 2001) and Mr. Jindal (HELP Committee hearing, 
February 13, 2002).
---------------------------------------------------------------------------
    For instance, a national telephone survey of more than 
1,000 people found that 63 percent of respondents said they 
would not take genetic tests if health insurers or employers 
could get access to the results.\3\ In a study of the use of 
genetic tests in clinical oncology, 68 percent of patients 
responding to a questionnaire reported that they would not bill 
health insurance companies for genetic tests for fear of 
discrimination, while 26 percent would take tests only using an 
alias.\4\ Genetic counselors report that concerns about 
breaches of privacy and improper use of genetic information are 
widespread among their patients. Concealment of the results of 
genetic tests can have sometimes disastrous consequences for 
individuals' health. For example, a woman whose doctor is 
unaware that her genetic profile includes an elevated risk for 
cancer may be less vigilant about possible warning signs of 
that cancer than a doctor who was fully aware of her genetic 
risks.
---------------------------------------------------------------------------
    \3\ ``Genetic Information and the Workplace'', a report issued by 
the Department of Labor, Department of Health and Human Services, Equal 
Employment Opportunity Commission and Department of Justice. Report 
date: January 20, 1998. Displayed at http://www.genome.gov/10001732; 
viewed on February 21, 2007.
    \4\ Matloff, E. et al. ``What Would You Do? Specialists' 
Perspectives on Cancer Genetic Testing, Prophylactic Surgery, and 
Insurance Discrimination.'' Journal of Clinical Oncology, 18: 2484-2492 
(2000).
---------------------------------------------------------------------------
    These surveys are substantiated by evidence documenting 
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.\5\ 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.\6\ Similar results are seen with other disorders. In a 
study of women who may carry the BRCA mutation, only 57 percent 
of women decided to undergo a genetic test to determine whether 
they carried a mutation in this gene.\7\ Although other factors 
contribute to the decision not to get tested, such as the lack 
of an effective treatment, fear of genetic discrimination 
appears to be a primary reason that many people forgo getting 
genetic tests.
---------------------------------------------------------------------------
    \5\ Lerman et al., ``Genetic testing in families with hereditary 
nonpolyposis colon cancer.'' JAMA 281: 1618-1622 (1999).
    \6\ Hadley, D. et al. ``Genetic counseling and testing in families 
with hereditary nonpolyposis colorectal cancer.'' Archives of Internal 
Medicine, 163: 573-582 (2003).
    \7\ Lerman et al. ``BRCA1 testing in families with hereditary 
breast-ovarian cancer. A prospective study of patient decisionmaking 
and outcomes.'' JAMA. 275:1885-1892 (1996).
---------------------------------------------------------------------------
    In addition to concerns about discrimination, polls 
indicate that the public at-large desires to keep genetic 
information private. For instance, in a 1995 Harris poll, 85 
percent of respondents indicated that they were either ``very 
concerned'' or ``somewhat concerned'' that insurers and 
employers might gain improper access to their genetic data.\8\ 
More recently, a 2004 a poll taken by the Genetics and Public 
Policy Center at Johns Hopkins University found that 92 percent 
of those surveyed felt that employers should not have access to 
genetic test results.\9\ Fears about the possible misuse of 
genetic knowledge appear to influence the public's desire to 
protect the privacy of genetic information.
---------------------------------------------------------------------------
    \8\ Statement of Francis S. Collins, M.D., Ph.D. to the 
Congressional Task Force on Health Records and Genetic Privacy 
Preventing Genetic Discrimination in Health Insurance, July 22, 1997.
    \9\ ``Reproductive Genetic Testing: What America Thinks'' Genetics 
and Public Policy Center, Johns Hopkins University, 2004, displayed at 
http://www.dnapolicy.org/pub.reports.php?action=detail&report;_id=6.
---------------------------------------------------------------------------
    Fears that employees may be subjected to unwanted or covert 
genetic testing by their employers, or may face discriminatory 
treatment, on the basis of that testing are not hypothetical. 
In 2000, the American Management Association conducted a 
``Workplace Testing Survey'' and found that a few of its 
members did use what they understood to be genetic information 
in hiring and firing decisions. Of the 2,133 employers 
surveyed, seven (up from three in 1999) indicated that their 
companies performed what they thought was genetic testing of 
employees. Of these seven, four reported performing genetic 
testing of job applicants, and six reported performing genetic 
testing of employees. In 1989, the United States Congress 
Office of Technology Assessment (OTA) surveyed Fortune 500 
companies. Of the 330 companies responding, 12 companies 
admitted to currently conducting genetic tests of employees.
    Although surveys and polls demonstrate a fairly widespread 
fear of discrimination, there is little evidence or 
documentation of actual discrimination in health insurance. For 
instance, the American Academy of Actuaries notes that private 
insurers do not require applicants for insurance to undergo 
genetic testing or use genetic tests to limit coverage for 
preexisting conditions.\10\
---------------------------------------------------------------------------
    \10\ American Academy of Actuaries, Genetic Information and Medical 
Expense Insurance, June 2000.
---------------------------------------------------------------------------
    Another study of insurance practices found there are almost 
no well-documented cases of health insurers either asking for 
or using presymptomatic genetic test results in their 
underwriting decisions. The same study found that ``some 
insurers clearly do use family history information for 
important disease categories such as heart disease, cancer, and 
diabetes, but they do so only to look for or evaluate other 
signs of existing or prior disease, not to predict the onset of 
future health problems.'' \11\
---------------------------------------------------------------------------
    \11\ Mark A. Hall and Stephen S. Rich, ``Laws Restricting Health 
Insurers' Use of Genetic Information: Impact on Genetic 
Discrimination.'' American Journal of Human Genetics, January 2000.
---------------------------------------------------------------------------
    Despite the apparent conflict between actual discrimination 
versus the fear or perception of discrimination, consumers 
remain worried that, once acquired by an insurance company or 
employer, genetic information could be used in a discriminatory 
manner. Such concerns about the misuse of genetics are already 
hindering the potential of the human genome project. Health 
care professionals advise patients to skip tests or pay for 
them out of pocket because they are uncertain if genetic 
information is protected from misuse under the law. Under our 
current patchwork of varying State and Federal laws, many of 
which were crafted for different purposes than genetic 
discrimination, few people truly understand the degree to which 
their genetic information may or may not be protected. Many of 
the problems outlined in this section stem from the lack of a 
comprehensive Federal law prohibiting the use of genetic 
information to deny health insurance coverage or affect 
employment status.
    Fear of discrimination, or even potential discrimination, 
threatens society's ability to use new genetic technologies to 
improve human health and the scientific community's ability to 
conduct research needed to understand, treat, and prevent 
disease. And, although there may not be proof of widespread 
discrimination, it is difficult to ignore the few, albeit 
egregious, cases that have been publicly documented.

                   EXAMPLES OF GENETIC DISCRIMINATION

    Although genes are facially neutral markers, many genetic 
conditions and disorders are associated with particular racial 
and ethnic groups, and gender. Members of those groups may be 
stigmatized or discriminated against as a result of that 
genetic information. This principle 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. The screening programs were designed to 
identify both healthy carriers and carriers with the manifested 
disease, even though neither prenatal diagnosis nor treatment 
was available at the time. Scientists suggested that even 
healthy carriers might be hyper-susceptible to certain 
workplace toxins such as benzene, lead, cadmium, carbon 
monoxide, and cyanide. Based on these opinions, employers began 
testing workers for the gene even though available evidence and 
studies did not support this theory. See Genetic Discrimination 
in the Workplace: An Overview of Existing Protections, 30 
Loyola University of Chicago Law Journal 393, 402-03 (Spring 
1999), citing Katherine Brokaw, Comment, Genetic Screening in 
the Workplace and Employer's Liability, Columbia Journal of Law 
& Social Problems 317, 324, n. 33 (1990).
    State legislatures began to take steps in the area, and in 
the early 1970s began mandating genetic screening of all 
African-Americans for sickle cell anemia, leading to further 
fear and discrimination. Inadequate measures to keep the test 
results confidential led to stigmatization and discrimination 
against sickle cell carriers in employment. Further, lack of 
knowledge and understanding of the disease led to 
discrimination against many carriers of the trait even though 
they would never develop sickle cell disease. 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. See 42 U.S.C. 
Sec. 300b.
    Between 1968 and 1993, Lawrence Berkeley Laboratory, a 
research institution operated jointly by State and Federal 
agencies, gave employees pre-placement medical examinations 
that included, without the employees' knowledge or consent, 
blood and urine tests for syphilis, sickle cell trait, and/or 
pregnancy. In Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 
135 F.3d 1260, 1269 (9th Cir. 1998), the court held that:

          it goes without saying that the most basic violation 
        possible involves the performance of unauthorized 
        tests--that is, the nonconsensual retrieval of 
        previously unrevealed medical information that may be 
        unknown even to plaintiffs. These tests may also be 
        viewed as searches in violation of fourth amendment 
        rights that require fourth amendment scrutiny. The 
        tests at issue in this case thus implicate rights 
        protected under both the fourth amendment and the Due 
        Process Clause of the fifth or fourteenth amendments.

    In 2001, railroad workers at Burlington Northern Santa Fe 
Railroad (BNSF) were subjected to genetic testing without their 
knowledge or informed consent. BNSF conducted genetic tests on 
samples drawn under false pretenses to try to determine whether 
employee's symptoms resembling carpal tunnel syndrome were 
caused by a genetic mutation. Employees of BNSF testified 
before Congress about how they were denied employment benefits 
and were otherwise deprived of equal protection under the law 
due to the misuse of their genetic information. On April 6, 
2001, BNSF settled the suit filed by the Brotherhood of 
Locomotive Engineers with the Equal Employment Opportunity 
Commission under the ADA.\12\
---------------------------------------------------------------------------
    \12\ Testimony of David Escher, HELP Committee Hearing, July 25, 
2001.
---------------------------------------------------------------------------

       FEDERAL LAW ON GENETIC DISCRIMINATION IN HEALTH INSURANCE

    The Health Insurance Portability and Accountability Act 
(HIPAA) affords some protection against discriminatory 
practices in health insurance based on an individual's genetic 
information. In general, HIPAA ensures that individuals who 
change health insurance carriers (usually after switching jobs 
or losing employment) do not have their coverage denied or 
unduly restricted because of pre-existing medical conditions. 
HIPAA also prohibits a health insurance carrier from charging 
one individual within a group higher rates than other 
``similarly situated'' individuals in the same group or 
determining eligibility to enroll in health insurance coverage, 
based on a health status-related factor. HIPAA includes genetic 
information as part of its definition of a ``health status-
related factor'' which cannot be used to deny coverage, and 
excludes genetic information (in the absence of a diagnosis) 
from its definition of a pre-existing medical condition.
    Nonetheless, the Act 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.
    Based on the evidence described above and on testimony 
received at several hearings on genetic discrimination, the 
committee determined that new Federal legislation is required 
to ensure that individuals are not denied health insurance 
coverage or do not have their premium rates raised due to 
genetic information that is not an analysis of metabolites or 
proteins directly related to a manifested disease, disorder, or 
pathological condition.

                           HIPAA AND PRIVACY

    In addition to its provisions on health insurance coverage, 
HIPAA also deals with the privacy of medical records. HIPAA 
stated that if Congress failed to enact a comprehensive law on 
medical privacy by August 21, 1999, then the Secretary of HHS 
would be required to issue privacy regulations. Since Congress 
was unable to enact a privacy law by the required deadline, HHS 
issued regulations on medical records privacy in December 2000 
that went into effect for large businesses in April 2003 and 
will take effect for small businesses 1 year later.
    The 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. Witnesses at several committee 
hearings testified that a statutory framework to protect 
genetic information directly--even when held by a non-covered 
entity such as an employer--would be a clearer and more 
effective system of regulation than relying solely on the 
indirect system of ``business associate'' contracts established 
under the HIPAA regulations.\13\ Based on this and other 
evidence, the Committee determined that further statutory 
provisions were 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.
---------------------------------------------------------------------------
    \13\ Testimony of Joanne L. Hustead (HELP Committee hearing, 
February 13, 2002).
---------------------------------------------------------------------------
    Within the sphere of health insurance, the regulations 
promulgated under HIPAA provide extensive regulatory direction 
on the permitted and impermissible uses of protected health 
information, including genetic information. In its 
deliberations, the committee took note of these regulations and 
determined that it would be advisable to enact genetic 
protections that were consistent with this existing framework.

    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.
    Most employees in the private sector, however, enjoy no 
similar protections. In several hearings, the committee heard 
testimony that existing Federal employment laws, the Americans 
with Disabilities Act (ADA) and title VII of the Civil Rights 
Act of 1964 (Title VII) provide limited or uncertain 
protections against the discriminatory use of genetic 
information in the workplace.\14\
---------------------------------------------------------------------------
    \14\ For example, testimony of Sen. Tom Daschle, Dr. Francis 
Collins, and EEOC Commissioner Paul Steven Miller (HELP Committee 
hearing, July 20, 2000).
---------------------------------------------------------------------------

               TITLE VII OF THE CIVIL RIGHTS ACT OF 1964

    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 
just described, its applicability to genetic discrimination is 
limited. The plain language of the statute provides no obvious 
protection against genetic discrimination. However, 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 example, the genetic mutation associated with Tay-Sachs 
Disease is found most commonly in persons with an Eastern 
European Jewish ethnic background. If an employer were to 
selectively refuse to hire carriers of the Tay-Sachs mutation, 
this action would have a disproportionate effect on people with 
a specific national or ethnic origin. In this limited 
circumstance, the individuals experiencing such discrimination 
might have a claim under title VII.\15\ However, for acts of 
genetic discrimination that do not have a discriminatory effect 
on members of a class of individuals named in the Civil Rights 
Act, title VII would provide no apparent protection against 
genetic discrimination.
---------------------------------------------------------------------------
    \15\ See Norman-Bloodsaw v. Lawrence Berkeley Lab., 135 F.3d 1260, 
1272-72 (9th Cir. 1988). In this case, the Lawrence Berkeley Labs had 
subjected the plaintiffs to testing the disorders that included sickle 
cell disease, a condition that is especially prevalent among African-
Americans. The Court found that in subjecting African-American 
employees to testing for this disorder, Lawrence Berkeley Labs violated 
their protections under title VII.
---------------------------------------------------------------------------

                  STATE LAW ON GENETIC DISCRIMINATION

    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/or employment. To date, 34 States have passed 
laws on genetic discrimination in employment and 48 have passed 
laws on genetic discrimination in health insurance.\16\ 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 
announced intention of detecting genetic mutations.
---------------------------------------------------------------------------
    \16\ Genetic Technologies Project, National Conference of State 
Legislatures; displayed at http://www.ncsl.org/programs/health/
genetics/ndiscrim.htm and http://www.ncsl.org/programs/health/genetics/
ndishlth.htm; viewed on February 21, 2007.
---------------------------------------------------------------------------
    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 this act, 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.
    In view of the need for national comprehensive protections 
against genetic discrimination, the committee has considered 
and by a vote of 19 to 2 approved the Genetic Information 
Nondiscrimination Act to provide the American people with the 
assurances they deserve that their genetic profiles will not be 
used to deny them health insurance or to discriminate against 
them in the workplace.

            III. Legislative History and Votes in Committee

    The committee, whether chaired by a Republican or Democrat, 
has made passage of bipartisan genetic nondiscrimination 
legislation a top priority. Under the chairmanship of Senator 
Kennedy in the 107th Congress, the committee held hearings on 
the issue of genetic discrimination. In the 108th Congress, 
under the leadership of Senator Gregg, the committee took 
executive action on bipartisan legislation to prohibit genetic 
discrimination in health insurance and employment, approving it 
without objection. Senator Enzi, as Chairman of the committee 
in the 109th Congress, maintained the strong commitment to 
enacting this needed legislation, and the committee once more 
took executive action on legislation to prohibit genetic 
discrimination, again without objection. Now, in the 110th 
Congress, the committee has again approved bipartisan 
legislation to prohibit genetic discrimination.

                               BACKGROUND

    Legislation addressing genetic discrimination first 
appeared in the 103d Congress as part of the national health 
reform debate. In the 104th Congress, as government and 
private-sector scientists were getting closer to sequencing the 
human genome, a handful of bills addressing genetic 
discrimination exclusively were introduced. Sponsors of these 
bills included an almost equal number of Republicans and 
Democrats. The various bills focused on different concerns 
about genetic discrimination and privacy. Most of these bills 
addressed discrimination in health insurance, while others also 
addressed genetic privacy and employment discrimination.
    During the 104th, the HELP Committee began to hold hearings 
on the topic. The first hearing examined the public policy 
implications of advances in genetics research. In 1996, the 
Senate passed the first genetic nondiscrimination legislation 
as part of the Health Insurance Portability and Accountability 
Act (HIPAA). HIPAA was signed into law in 1996 (P.L. 104-191; 
August 21, 1996). It prohibits discrimination against an 
individual in a group based on health status, including genetic 
information, and it primarily applies to group health plans and 
health insurance issuers in the group market.
    HIPAA did not directly address medical privacy; however, 
HIPAA required HHS to promulgate comprehensive medical privacy 
regulations if Congress did not pass legislation addressing the 
same by August 21, 1999. Several bills addressing comprehensive 
medical privacy were introduced in the 105th and 106th 
Congress, but the Senate did not act, and HHS proceeded to 
promulgate regulations.
    From 1996 through 2002, the committee explored thoroughly 
issues related to genetic discrimination in health insurance 
and employment. The committee held a total of five hearings on 
genetic discrimination. In addition, the committee has also 
held hearings on medical privacy, which is relevant to 
genetics.

              COMMITTEE HEARINGS ON GENETIC DISCRIMINATION

    July 25, 1996: Advances in Genetics Research and 
Technologies: Challenges for Public Policy--Examining recent 
developments in genetics research, public policy issues with 
regard to access to and use of genetic information, and the 
impact of genetic technologies on certain sectors of industry, 
health care delivery systems, and the public.
    May 21, 1998: Genetic Information and Health Care--
Examining proposals to prohibit health care discrimination 
based on genetic information, including related measures on S. 
89 and S. 422.
    July 20, 2000: Genetic Information in the Workplace--
Examining issues relating to the development of Federal policy 
governing the treatment of an individual's genetic information 
in the workplace in light of the recent Human Genome Project 
breakthroughs.
    July 25, 2001: Fulfilling the Promise of Genetic Research: 
Ensuring Nondiscrimination in Health Insurance and Employment--
Examining S. 318, to prohibit discrimination on the basis of 
genetic information with respect to health insurance, and 
related genetics research issues regarding employment 
discrimination and prevention of disclosure of genetic 
information to third parties.
    Feb. 13, 2002: Protecting Against Genetic Discrimination: 
The Limits of Existing Laws--Examining the existing laws and 
proposed legislation necessary to protect genetic information 
in order to prevent genetic discrimination that may lead to 
loss of health insurance or employment discrimination, 
including S. 318 and S. 382, to prohibit discrimination on the 
basis of genetic information with respect to health insurance.

                     COMMITTEE, FLOOR CONSIDERATION

    Subsequent to HIPAA, both the HELP Committee and the full 
Senate have considered broader genetic discrimination 
legislation. In the 106th Congress, Senator Jeffords introduced 
the Patient's Bill of Rights Act (S. 326), which included 
genetic nondiscrimination and privacy provisions applying to 
health insurance. The genetics provision in this legislation 
was a modified version of the ``Genetic Information 
Nondiscrimination in Health Insurance Act of 1997'' (S. 89), 
introduced by Senator Snowe in the 105th Congress.
    During the committee's consideration of S. 326, Senator 
Dodd offered an amendment that would have limited the 
disclosure of predictive genetic information and prohibited 
employers from discrimination on the basis of genetic 
information. The amendment was not accepted. Senator Jeffords 
agreed to hold a hearing on genetic discrimination in the 
workplace, which he did on July 20, 2000. The Patient's Bill of 
Rights legislation (S. 326), with the modified genetic 
nondiscrimination provision from S. 89, was approved by the 
HELP Committee on March 18, 1999 by a vote of 10 yeas to 8 
nays.
    The full text of S. 326 was incorporated into Senate 
Amendment 1232, to the Patient's Bill of Rights (S. 1344), 
which was approved by the Senate on July 15, 1999. This bill 
was considered during a House/Senate conference, with House 
bill H.R. 2990, which did not produce a Conference Report for 
reasons other than genetic nondiscrimination.
    Also in the 106th Congress, on June 29, 2000, Senator 
Daschle offered Senate Amendment 3688, genetic 
nondiscrimination legislation he had previously introduced (S. 
1322), to the Labor/HHS appropriations legislation (H.R. 4577). 
The amendment was not accepted. To the same legislation, 
Senator Jeffords offered Senate Amendment 3691, genetic 
nondiscrimination legislation (S. 543) introduced by Senator 
Snowe on March 4, 1999, and that amendment was approved. The 
provision was not included in the final Labor/HHS report.
    In the 107th Congress, Senator Daschle reintroduced the 
``Genetic Nondiscrimination in Health Insurance and Employment 
Act'' (S. 318) on February 13, 2001. Senator Snowe reintroduced 
the ``Genetic Information Nondiscrimination in Health Insurance 
Act of 2001'' (S. 382) on February 15, 2001.
    On June 28, 2001, Senator Ensign offered Senate Amendment 
849, to the Patient's Bill of Rights legislation (S. 1052) 
under consideration by the full Senate. The amendment was 
approved without objection. The amendment contained provisions 
relating to discrimination and privacy in health insurance and 
employment. The Senate did not appoint conferees on S. 1052, 
and there was no further action on this amendment.
    On March 6, 2002, Senator Snowe modified her legislation to 
reflect the release of the HHS medical privacy regulations and 
to include a new title II addressing employment discrimination 
(S. 1995). Working from these two bills, the HELP Committee 
began to explore whether and how these bills could be merged 
into a singe bipartisan bill.
    In the 108th Congress, Senator Daschle reintroduced his 
bill as part of a broader civil rights bill ``a Bill to Protect 
the Civil Rights of All Americans'' (S. 16) on January 7, 2003. 
On May 13, 2003, Senator Snowe reintroduced her legislation 
from the 107th Congress (S. 1995) without modification. This 
legislation (S. 1053), was the bill that the committee moved to 
consider. During the May 21, 2003 executive session, Chairman 
Gregg offered compromise language based on the Snowe and 
Daschle legislation as a manager's substitute to S. 1053. 
Senate bill S. 1053, as modified by the manager's substitute, 
was approved without objection by the committee on May 21, 
2003. On October 14, 2003 the Senate approved S. 1053 by a vote 
of 95 to 0. The House did not take up the legislation, and 
there was no further action on it.
    In the 109th Congress, Senator Snowe reintroduced the 
legislation passed in the 108th Congress with modifications 
that made corrections in dates and other technical changes. The 
Genetic Information Nondiscrimination Act of 2005, S. 306, was 
introduced on February 7, 2005. The HELP Committee approved S. 
306 without objection on February 9, 2005. On February 16, 
2005, the full Senate considered S. 306, as amended by Senate 
Amendment 13, a manager's substitute. The Senate approved S. 
306, as amended, by a vote of 98 to 0. The House again took no 
action on the bill.
    In the 110th Congress, Senator Snowe reintroduced the 
legislation approved by the Senate in the 109th Congress with 
modifications that made corrections in dates and other 
technical changes. The Genetic Information Nondiscrimination 
Act of 2007, S. 386, was introduced on January 22, 2007. The 
HELP Committee approved the bill with a Chairman's substitute 
on January 31, 2007 by a vote of 19 yeas and 2 nays. Voting in 
the affirmative were Senators Kennedy, Enzi, Dodd, Gregg, 
Harkin, Alexander, Mikulski, Isakson, Bingaman, Murkowski, 
Murray, Hatch, Reed, Roberts, Clinton, Allard, Obama, Sanders, 
and Brown. Voting in the negative were Senators Burr and 
Coburn.

              IV. Explanation of Bill and Committee Views


         Title I--Genetic Nondiscrimination in Health Insurance


                              DEFINITIONS

    The definitions of ``family member,'' ``genetic 
information,'' ``genetic test,'' and ``genetic services'' 
provide the foundation for this legislation. These terms are 
used in every section of title I and have the same definition 
in each instance. The committee wishes to emphasize that title 
I only applies to health insurance underwriting and eligibility 
practices and is not in any manner intended to regulate the 
delivery of medical care and treatment.
    The legislation includes ``the occurrence of a disease or 
disorder in family members of the individual,'' herein after 
referred to as ``family medical history,'' in the definition of 
genetic information. The committee intends for `'family medical 
history'' to be understood as it is used by medical 
professionals when treating or examining patients. For example, 
the American Medical Association (AMA) has developed an adult 
family history form as a tool to aid the physician and patient 
to rule out a condition that may have developed later in life, 
which may or may not have been inherited. This form requests 
information about the patient's brothers, sisters, and their 
children, biological mother, the mother's brothers, sisters, 
and their children, maternal grandfather, maternal grandmother, 
biological father, the father's brothers, sisters, and their 
children, paternal grandfather and paternal grandmother. The 
committee expects that the use of ``family history'' in this 
bill will evolve with the medical profession and the tools they 
develop in this area.
    The committee realizes that a family medical history could 
be used as a surrogate for a genetic trait by a health plan or 
health insurance issuer. A consistent history of a heritable 
disease in a patient's family may be viewed to indicate that 
the patient himself or herself is at increased risk for that 
disease. For this reason, the committee believes it is 
important to include family medical history in the definition 
of ``genetic information.'' In so doing, the committee followed 
the recommendations of numerous leading experts in genetic 
science.
    A key element in the definition of genetic information is 
the term ``genetic test.'' ``Genetic test'' is defined in the 
legislation to mean ``an analysis of human DNA, RNA, 
chromosomes, proteins, or metabolites, that detects genotypes, 
mutations, chromosomal changes.'' This definition excludes ``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.'' The committee is aware that many tests are used to 
determine existing diseases, disorders, and conditions, and 
does not intend to include in the definition of genetic 
information such tests when they indicate the presence of a 
manifested disease, disorder, or pathological condition.
    The committee recognizes that, as part of the underwriting 
process, an individual may be asked to be examined by a 
physician or take certain lab tests. The committee also 
recognizes that medical underwriting may not involve such an 
exam or new tests and may instead be based on a medical records 
review or a review of previously-taken lab tests. For instance, 
a person applying for health insurance who has had a full 
physical six months prior, may simply supply the results of 
such prior tests to the insurance company rather than submit to 
retaking the same battery of tests. In this case, the committee 
intends that any analysis of proteins and metabolites that 
indicates a manifested disease, disorder, or pathological 
condition would still fall within the exception to ``genetic 
test'' in this section, regardless of the fact that the test 
had been conducted preceding the application for coverage.
    By including the exception to genetic test for a manifested 
disease, disorder, or pathological condition, the committee 
sought to draw a bright line between genetic information and 
information about a manifested disease, disorder, or 
pathological condition. In addition to genetic traits, there 
are other factors that may contribute to the manifestation of a 
disease or disorder. The committee believes there is great 
danger, especially in these early stages of scientific 
discovery, of genetic information being misapplied in the 
context of health insurance underwriting and thus believes it 
should be prohibited. While this distinction is important for 
purposes of this legislation, the committee recognizes that it 
may not be possible or even desirable in health care delivery 
or scientific research to isolate genetic information as it 
pervades health information.
    This legislation intentionally does not include in its 
definition of ``genetic information'' the results of analyses 
of proteins or metabolites that indicate a manifested disease, 
disorder, or pathological condition. The committee recognizes 
that, while it may have been easier to craft a single set of 
Federal rules governing discrimination based on all health 
information, rather than trying to isolate and define genetic 
information, State and Federal law already regulates the use of 
health information in rating and eligibility practices. With 
respect to group health plans, ERISA, the Public Health Service 
Act (PHSA), and the Internal Revenue Code (IRC) currently ban 
discrimination in eligibility or premiums based on the health-
status of an individual in the group. This prohibition was 
enacted as part of the Health Insurance Portability and 
Accountability Act in 1996. In addition, States regulate rating 
and eligibility practices of insurance issuers in the 
individual market, a highly sensitive market with 
characteristics unique to each State. As the primary regulators 
of this market, States can reassess and change their 
regulations of this market to ensure that carriers will 
continue to offer products. The committee saw no rationale for 
supplanting the group market rules or pre-empting State rating 
requirements. Instead, the committee invested substantial time 
and effort circumscribing genetic information.
    The terms ``genetic information'' and ``genetic test'' 
address the substantive results of tests, and the legislation 
prohibits discrimination on the basis of these factors. The 
legislation also protects, in the same manner, against 
discrimination on the basis of an individual having taken a 
test. In addition, the legislation protects the activities 
associated with genetic information, including genetic 
counseling (such as obtaining, interpreting, or assessing 
genetic information) and genetic education. All these functions 
are protected under the definition of ``genetic services.''

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

    The committee recognizes that ERISA Section 702(a)(1)(F) 
and 702(b) currently prohibits 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. With 
this section, the committee intends to clarify and expand these 
protections, and the remedies and enforcement provided for 
these protections, for group health plan participants and 
beneficiaries governed by ERISA.
    Genetic Services: The committee believes that, in addition 
to discrimination based on actual genetic information, there is 
potential for discrimination based on the mere action of 
requesting or receiving a genetic service. For example, a 
health plan could potentially wrongly assume that a participant 
has a genetic disorder, such as Huntington's disease, because 
the participant, or his or her family member, requested or 
received a genetic test for the disease. This assumption could 
also be made if an individual had participated in a clinical 
trial for a disease associated with a particular genotype. 
Thus, the term ``genetic services'' encompasses genetic 
services received as part of a clinical trial. This definition 
clarifies, 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 genetic services by an 
individual or family member of such individual.'' Participation 
in a clinical trial in which genetic services are provided 
would also constitute ``information about a request for or 
receipt of genetic services.''
    The committee's interpretation regarding the inclusion of 
``information about a request for or receipt of genetics 
services by an individual or family member of such individual'' 
applies in each section in which this provision appears, 
including sec. 102(a)(1)(B) with respect to health insurance 
issuers offering coverage in connection with a group health 
plan, sec. 2753(a) with respect to a health insurance issuer in 
the individual market, and section 103 with respect to an 
issuer of a Medicare supplemental policy.
    Discrimination in Premiums Against the Group as a Whole: 
While current law protects individuals in a group from being 
charged premiums or contributions that are higher than the 
premiums or contributions for similarly situated individuals, 
there is no such protection in current law for the group as a 
whole. Thus, this section prohibits a health insurance issuer 
offering 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.
    The committee is aware that health plans and insurers use 
actual claims experience to set initial and renewal premiums 
for groups. And, among the claims experience that a health plan 
may use to set or renew premium rates are the costs, as opposed 
to the results, of genetic tests and services. The committee 
believes that the costs of medical items and services used by 
an individual do not meet the definition of ``genetic 
information'' or ``genetic services'' under this bill, and 
therefore are not banned for use by health plans to set or 
renew premiums rates for the group as a whole.
    The committee also recognizes that claims data used to set 
or renew premiums for the group as a whole are likely to 
include a range of information such as utilization, payment, 
and cost data for family members of individuals enrolled in the 
group. While genetic information is defined broadly in this 
bill to include ``family history,'' the committee does not 
believe, nor does it intend for this provision to prohibit a 
health plan from setting or renewing rates for the group as a 
whole based on the claims data concerning health status of 
members of the group who may also happen to be family members 
of other individuals in the group. The committee believes that 
the inclusion of family history in the definition of genetic 
information should not pose this problem because nothing in 
this legislation prohibits a health plan from taking into 
consideration, when setting or renewing premiums, the health 
information of each person enrolled in the group.
    The interpretation of this section 101(a)(2) applies in 
each section in which this provision appears in the bill, 
including sec. 102(a)(1)(B) with respect to health insurance 
issuers offering coverage in connection with a group health 
plan.
    Limitation on Genetic Testing: Sec. 101(b) places limits on 
a group health plan''s ability to request or require an 
individual, or the family member of the individual, to take a 
genetic test. As the decision to take a genetic test is a 
personal one and could be influenced by many factors, including 
whether or not any treatment exists for a particular disease, 
the committee included this prohibition to ensure that 
individuals would not feel compelled to take a genetic test. 
However, the committee also wishes to ensure that this 
provision does not interfere with health care practices that 
could be beneficial to the individual, so several 
clarifications of this provision are included in the 
legislation. For instance, this provision does not limit in any 
manner the authority of the treating health care professional 
to request that an individual or family member undergo a 
genetic test. However, the treating health care professional 
may not require the individual or family member to undergo a 
genetic test. The committee intends for the term ``health care 
professional who is providing health care services with respect 
to an individual'' to apply to any health care professional who 
is a member of the practice group from which a patient receives 
health care services.
    The committee believes that, given different motivations by 
and perceptions of health plans versus treating health care 
professionals, this distinction is warranted. However, the 
committee is also aware that some health plans go beyond the 
insurance function and engage in wellness and disease 
management programs; and the committee does not wish to 
discourage such efforts. Thus, section 101(b) makes it clear 
that this legislation does not limit the authority of a health 
care professional who is employed by or affiliated with the 
group health plan or health insurance issuer 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.
    The term ``wellness program'' is defined by regulations 
promulgating ERISA's nondiscrimination provisions under section 
702. In summary, these regulations define a ``wellness 
program'' as one that does more than simply charging 
differential premiums based on health risk factors. For 
instance, a wellness program might include a rebate for not 
smoking, but it would also have to offer a smoking cessation 
program. The committee believes that the concept of a wellness 
program is important in the context of genetic discrimination 
to ensure that a health plan does not use a wellness program as 
a subterfuge to discriminate in insurance premiums based on 
genetic information.
    The provision prohibiting a health plan from requesting or 
requiring an individual to undergo a genetic test was included 
to protect health plan participants from actions that would 
allow a health plan to obtain genetic information to be used 
for the purposes of insurance discrimination. It only addresses 
the act of requesting or requiring an individual to undergo a 
test. The committee recognizes that this provision does not 
address the use, disclosure, or collection of existing test 
results and intends for the flow of genetic information to be 
governed by the HHS medical privacy rules and section 104 of 
title I of this legislation.
    A description of activities not covered by section 
702(c)(1) (as added by section 101 of the bill) may be 
important in delineating the scope of this section.
    Subsection (c)(1) covers only the interaction between a 
health plan or a health insurance issuer offering health 
insurance coverage in connection with a group health plan and 
an individual or family member of an individual.
    Increasingly, information from genetic testing will be 
crucial to determining the therapy or preventive health care 
services most effective for a particular patient. For that 
reason, it is important to note that subsection (c)(1) does not 
preclude health care professionals from requesting or 
recommending that their patients undergo genetic tests or 
receive genetic services. The committee took great care to 
ensure that the legislation did not interfere with the ability 
of health professionals to provide care for their patients. 
Indeed, by giving patients greater confidence that they can 
undergo genetic testing without fear that their genetic 
information will be used for discriminatory purposes, the 
legislation will facilitate the appropriate use of genetic 
tests. The Rule of Construction in subsection (c)(2)(A) makes 
explicit that subsection (c)(1) does not apply to interactions 
between health care professionals and the patients they treat.
    Another feature of the exception in subsection (c)(2)(A) is 
that is not limited by the employment status of the health care 
provider. Thus, a physician is not barred from requesting that 
patients under his or her care undergo a genetic test 
regardless of whether, for example, that physician is in 
private practice or employed by an integrated health plan.
    Nor does subsection (c)(1) prohibit a health plan from 
making information about genetic tests available to physicians 
who provide health care services as part of that plan. Finally, 
subsection (c)(1) does not specify or limit the documentary 
evidence that a plan or health insurance issuer may require to 
substantiate payment for a claim.
    Hypothetical examples may be helpful in illustrating the 
scope of subsection (c)(1).
    Hypothetical #1: Dr. Washington is providing health care 
services to Ms. Adams, whose mother and aunt both died of 
breast cancer. Dr. Washington counsels Ms. Adams that her risk 
of breast cancer may be elevated, and recommends that she 
undergo a genetic test for BRCA1, mutations in which are 
associated with an elevated risk of breast and ovarian cancer. 
Subsection (c)(1), as noted above, does not limit 
communications between health care professionals and the 
patients to whom they provide care. Lest there be any ambiguity 
in the scope of the prohibition under subsection (c)(1), the 
Rule of Construction in subsection (c)(2)(A) further clarifies 
that the ability of Dr. Washington to request or recommend that 
Ms. Adams undergo the BRCA1 genetic test is not limited by the 
legislation.
    Hypothetical #2: Ms. Jefferson has been diagnosed with 
breast cancer. Her physician, Dr. Madison, is considering the 
appropriate course of therapy for Ms. Jefferson. He knows that 
if her tumor overexpresses the HER2/neu receptor, then Ms. 
Jefferson would be a good candidate for treatment with 
Herceptin, a humanized monoclonal antibody against the HER2/neu 
receptor. Conversely, if Ms. Jefferson's tumor does not 
overexpress HER2/neu, then Herceptin therapy would be 
contraindicated. Dr. Madison accordingly recommends to Ms. 
Jefferson that she undergo a genetic test for Her2/neu. Again, 
subsection (c)(1) does not apply to the interaction between Dr. 
Madison and Ms. Jefferson, and again, the Rule of Construction 
in subsection (c)(2)(A) further clarifies that the prohibition 
in subsection (c)(1) does not apply to this interaction. Dr. 
Madison is thus free to recommend that Ms. Jefferson undergo a 
genetic test for HER2/neu.
    Hypothetical #3: The Consolidated Mutual Insurance Company 
covers one colonoscopy every 10 years for beneficiaries above 
the age of 50. However, the plan covers the cost of an annual 
colonoscopy for beneficiaries of any age who have a mutation in 
one of several genes associated with elevated risk of 
hereditary nonpolyposis colorectal cancer (HNPCC). Mr. Monroe 
had a colonoscopy when he turned 50, the cost of which 
Consolidated Mutual covered. However, the following year, Mr. 
Monroe had a second colonoscopy for which he also sought 
reimbursement from Consolidated Mutual. Mr. Monroe claimed that 
Consolidated Mutual should cover the second colonoscopy on the 
grounds that a genetic test detected that he carries a mutation 
in one of the genes associated with elevated risk of HNPCC. 
Nothing in subsection (c)(1) prohibits Consolidated Mutual from 
requiring that Mr. Monroe provide evidence to show that he 
indeed did undergo the relevant genetic test, and that the 
results fell within the scope of conditions under which 
Consolidated Mutual's policy rules provide coverage for 
colonoscopies performed more frequently than once per decade.
    Hypothetical #4: Consolidated Mutual also has a program to 
inform health professionals about the value of genetic testing 
in providing appropriate care to their patients. Accordingly, 
Consolidated Mutual provides informational brochures on genetic 
testing to the health care professionals who provide services 
covered under the plan. Again, nothing in subsection (c)(1) 
regulates the flow of information between Consolidated Mutual 
and health professionals, so this communication is not 
prohibited.
    Hypothetical #5: Mr. Jackson holds a family health 
insurance policy with Consolidated Mutual that covers Mr. 
Jackson, his wife and his young son, Steven. Steven suffers 
from severe difficulties in breathing that are symptomatic of 
cystic fibrosis. Steven undergoes a ``sweat test'', a commonly 
performed analysis to detect abnormal levels of sodium and 
chloride ions in sweat. Steven's test reveals significant 
abnormalities in the levels of these ions. The definition of 
``genetic information'' in the legislation includes an 
exception for metabolic tests that are ``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.'' The sweat test is a metabolic test that directly 
relates to a manifested disease, cystic fibrosis. Thus, the 
results of the sweat test are not considered ``genetic 
information'' under section 101. Consolidated Mutual is thus 
not barred by this section from taking the results of the sweat 
test, or the fact of Steven's manifested cystic fibrosis, into 
account in setting premiums for a policy under which Steven is 
covered, even if such policy also includes Steven's parents.
    The interpretation of provisions in section 101 described 
above applies in each section in which identical provisions 
appear in the bill, including section 102 with respect to 
health insurance issuers, and section 103 with respect to an 
issuer of a Medicare supplemental policy.
    Application: This section applies to all non-governmental 
ERISA group health plans, including plans with less than two 
participants that are exempt from ERISA's existing 
nondiscrimination provisions. The committee believes that since 
the requirements of this section do not impose an 
administrative burden and since they are applied to individual 
insurance, there is no rationale for excluding these groups 
from this section. This section also applies to retiree- only 
plans. The interpretation of this section also applies in each 
section in which this provision appears in the bill, including 
section 102 with respect to health insurance issuers offering 
coverage in connection with a group health plan.
    Enforcement and Remedies: The legislation clarifies and 
strengthens remedies and enforcement available to all group 
health plan participants and beneficiaries governed by ERISA 
for violations of genetic discrimination under this section. 
Specifically, enforcement of this section is built on existing 
remedies under section 502(a)(1) of ERISA, which provides ERISA 
plan participants with a private right of action, as well as 
the Secretarial enforcement mechanisms from title I of HIPAA, 
which address insurance portability and discrimination based on 
health-status.
    This legislation clarifies that, with respect to a group 
health plan's violation of this section, a participant or 
beneficiary has the right to seek injunctive relief before 
exhausting administrative remedies if taking the time to pursue 
administrative remedies would cause irreparable harm to the 
participant's health. The committee also recognizes that while 
access to health coverage for a genetic predisposition itself 
would not likely threaten a participant's current health 
status, a health plan's denial of eligibility under the plan 
based on genetic information, could potentially threaten other 
aspects of an individual's, or his or her beneficiary's, 
health. Under current case law, a court may grant a participant 
or beneficiary the right to seek injunctive relief before 
exhausting administrative remedies on grounds other than that 
requiring exhaustion of administrative remedies would cause 
irreparable harm, as provided under this legislation. These 
have included cases where having to exhaust administrative 
remedies would be futile, where meaningful access to plan 
procedures has been denied and where the remedy sought is not 
available through the plan's claims review process.
    S. 358 is not intended to limit the discretion of a court 
to grant a beneficiary the right to seek injunctive relief 
before exhausting administrative remedies on grounds such as 
those cited above, or on such other grounds as the court may 
find appropriate. Rather, the legislation is intended to 
establish that a determination by a court that a health plan's 
violation of this section would cause irreparable harm shall 
always be considered sufficient grounds for the court to grant 
a participant or beneficiary the right to seek injunctive 
relief prior to the exhaustion of administrative remedies.
    In addition to injunctive relief, this legislation also 
clarifies the nature of relief available under section 502(a) 
with respect to a genetic discrimination violation under this 
Act. Where a participant or beneficiary obtains relief under 
ERISA for a genetic discrimination violation, the court has the 
discretion to reinstate coverage, retroactive to the date of 
the violation. The committee recognizes that most disputes over 
plan eligibility or premiums are resolved quickly and do not 
typically require legal action. The committee intends to 
clarify in statute that the court has the discretion to 
reinstate coverage retroactively with regard to violations of 
genetic discrimination.
    Should a participant or beneficiary recover benefits under 
section 502(a)(1)(B) for a violation of the amendments made by 
section 101 of this act, this legislation gives the court 
discretion to levy a penalty against the administrator for 
failure to comply with the requirements of this title. The 
amount of the penalty is not more than $100 for each day in the 
noncompliance period, and it is payable to the participant or 
beneficiary involved. The committee recognizes that, while the 
process is a departure from current law remedies, the level of 
remedy available under this provision for violations of genetic 
discrimination parallels what exists under current law for 
other HIPAA violations. In designing this provision, the 
committee was aware of similar provisions under ERISA where the 
court has the discretion to award penalties for a failure to 
provide plan documents or COBRA violations.
    The committee acknowledges that a private remedy is 
designed to primarily help the individual pursuing the remedy. 
Therefore the legislation applies the existing Secretarial 
enforcement mechanism and penalty structure created by HIPAA to 
the enforcement of genetic discrimination violations. The only 
changes this legislation makes to this model are to give 
enforcement authority to the Secretary of Labor rather than the 
Secretary of Treasury, and to convert the excise taxes to civil 
monetary penalties. Since DOL currently oversees HIPAA 
compliance and enforcement, and conducts plan audits, the 
committee believes that this model will encourage more 
efficient and timely enforcement of the requirements of genetic 
nondiscrimination.
    This legislation does not alter or modify existing remedies 
or enforcement, or any interpretation thereof, for any 
provision of current law other than violations of genetic 
discrimination as defined under this legislation. For example, 
this legislation does not modify the remedies available for 
violations of other health-status related discrimination under 
section 702.

Sec. 102. Amendments to the Public Health Service Act

    Group Insurance Market: The genetic nondiscrimination 
provisions that apply to insurance issuers offering coverage in 
connection with a group health plan are identical to the 
provisions created by section 101 of this act as amendments to 
ERISA. With one exception, there are duplicate provisions in 
the PHSA for each of the requirements in ERISA. Since ERISA 
provides the exclusive remedy for all ERISA group health plan 
participants, including those enrolled by a health insurance 
issuer offering coverage in connection with a group health 
plan, the legislation does not duplicate the remedies and 
enforcement provisions in the PHSA. However, the committee 
emphasizes that all group health plan participants and 
beneficiaries are entitled to the remedies and enforcement 
mechanisms under ERISA.
    Individual Insurance Market: This provision prohibits a 
health insurance issuer in the individual market from 
establishing rules of eligibility (including continued 
eligibility) or setting premium rates for an individual based 
upon genetic information (including information about a request 
for or receipt of genetic services by an individual or family 
member of such individual). The committee recognizes that 
currently there are no nondiscrimination protections in Federal 
law for the individual market and that States have the ability 
to extend genetic nondiscrimination protections to the 
individual insurance. However, the committee has chosen to 
create this Federal floor for several reasons.
    First, the committee had access to the Nation's leading 
experts and scientists in the field of genetics, including 
those from the National Human Genome Research Institute of the 
NIH, to assist in crafting delicate public policy in a field 
that is fairly new and rapidly advancing. Second, due to the 
rapid advancement of the science of genetics, protections vary 
widely from State to State, providing some consumers with 
better protection than others. Third, the committee believes 
that there is a timely need for a national standard to prevent 
genetic discrimination, and consumers across the Nation should 
not have to wait for the actions of dozens of individual State 
legislatures.
    This legislation applies the same enforcement model that 
title I of HIPAA created for the enforcement of group-to-
individual portability and other requirements for genetic 
discrimination violations, by an issuer in the individual 
market. Under that model, States are free to adopt the Federal 
standard or create a more protective standard. If a State fails 
to substantially enforce the Federal standard, the Secretary of 
HHS shall enforce the requirements against the insurance 
issuers in that State. To enforce their rights under this 
legislation, individuals may use whatever means, such as 
grievances and appeals, assistance from the State insurance 
commissioner's office, or any other remedies that may be 
available under State law, such as taking legal action, if the 
State's law provides such a remedy.
    The committee believes that employees and dependents 
covered under State and local governmental group health plans 
should also be covered by the protections of this legislation. 
Under HIPAA, State and local governmental plans may opt out of 
the protections that would otherwise apply to group health 
plans, and some have exercised that option. The committee 
believes that this legislation provides important protections 
without imposing a regulatory or cost burden on the plan, and 
thus believes that an opt-out is both inappropriate and 
unnecessary. This legislation thus ensures its protections are 
applicable and enforceable on State and local governmental 
group health plans.

Sec. 104. Privacy and Confidentiality

            Sec. 104(b). Compliance with certain confidentiality 
                    standards with respect to genetic information
    At a February 13, 2002 hearing before the HELP committee, 
the HHS Assistant Secretary of Planning and Evaluation 
testified about the interaction between genetic 
nondiscrimination legislation and the medical privacy rules. 
The Assistant Secretary testified that the HHS medical privacy 
rules cover all health information, including genetic 
information, in the same manner, and urged the committee not to 
craft legislation that creates a different set of privacy rules 
for genetic information.
    In general, the committee believes that treating all health 
information in a consistent or similar matter will encourage 
third-party payers to cover genetics tests, technologies, and 
services. After hearing much testimony and working with a wide 
range of stakeholders and consumer organizations, the committee 
was convinced that consistent treatment of all medical 
information is important in enabling genetics to become part of 
main-stream medicine. Finally, the committee concluded, 
especially with respect to the ``use and disclosure'' of 
information, that it is inherently difficult to separate 
genetic information from other medical information in the 
delivery of health care and medical research, and therefore 
inconsistent rules for the ``use and disclosure'' of different 
categories of health information would likely be burdensome and 
potentially harmful to patient care.
    In general, the legislation recognizes that the HHS medical 
privacy regulations apply to the ``use and disclosure'' of 
genetic information, provided that such regulations are not in 
conflict with this title.
    However, a provision in the medical privacy regulations 
pertaining to underwriting and insurance rating is inherently 
discriminatory, and thus inconsistent with the purpose of this 
legislation. Specifically, there is a provision in the privacy 
regulations, under the heading of ``health care operations,'' 
that allows, without prior consent, a covered entity to ``use 
or disclose'' genetic information for purposes of premium 
rating, underwriting, or establishing or renewing a contract 
for coverage or insurance. Since one of the purposes of this 
legislation is to prevent discrimination in premium rates, this 
provision prohibits a plan or issuer from using or disclosing 
genetic information 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.
    In addition, the legislation states that a covered entity 
shall not request, require, or purchase genetic information 
concerning a participant, beneficiary, or enrollee prior to the 
enrollment and in connection with such enrollment under the 
plan, coverage, or policy. This language was included because 
the HHS medical privacy regulations presume that covered health 
care entities possess health care information and thus the 
regulations focus on the ``use and disclosure'' of protected 
health information. Since health insurance issuers typically 
treat underwriting as a separate business function and process 
from coverage decisions and medical management, the committee 
believes that this important layer of protection will not 
adversely impact the delivery of patient care and health care 
improvement activities.
    The committee believes that if a covered entity is barred 
from using or disclosing genetic information for purposes of 
underwriting, they should not be able to collect such 
information in the first place as part of the underwriting, 
application, or some other pre-enrollment process or 
interaction. However, the committee also recognizes that there 
may be situations in which a health plan or insurance issuer 
obtains genetic information prior to enrollment, but not in 
connection with that particular enrollment. For instance, an 
individual seeking coverage under a plan currently may have 
been enrolled in the plan previously, and therefore the plan 
has likely, in making coverage determinations or conducting 
disease management activities, collected genetic information 
prior to the individual's current enrollment. Or, if a family 
member of an individual enrolling for coverage under a plan is 
already a member of the plan, such plan would likely have 
collected genetic information ``prior to enrollment.'' The 
committee did not intend to prohibit this type of collection 
and thus includes in the legislation the phrase ``and in 
connection with such enrollment'' to clarify. However, the 
committee emphasizes that, regardless of the means by which 
genetic information is collected, whether in connection with 
enrollment or not, sections 101-104 of the legislation 
prohibits health plans and health insurance issuers from using 
genetic information to adjust premiums or determine 
eligibility.
    The committee understands that genetic information 
permeates health information and that covered entities may 
inadvertently or unintentionally acquire genetic information. 
For instance, a health insurance issuer may purchase another 
health plan and all of its medical records, or request medical 
records or previously taken lab tests for purposes of 
underwriting. Or, in filling out an application for insurance 
that includes a medical questionnaire, an individual may 
voluntarily offer additional health information, such as family 
medical information which is considered genetic information 
under this bill. Thus, a provision addressing ``incidental 
collection'' is included in the legislation that makes it clear 
that if a plan, or an 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 and any genetic 
information obtained incidentally is not used or disclosed in 
violation of the HHS medical privacy regulations.
    The legislation applies to all group health plans and 
issuers that are otherwise covered by the HHS medical privacy 
rules. Therefore, there are a very limited number of plans and 
issuers, such as a group health plan with less than 50 
participants that self-administers, that are covered by the 
nondiscrimination provisions of this bill but not under this 
section. The committee believes that since the privacy 
provisions contained in this legislation are inextricably 
linked to and coordinated with the HHS privacy regulations, it 
would be difficult for an entity to comply with the 
requirements of this section without also complying with all of 
the medical privacy regulations. The committee did not wish to 
introduce for the first time such a substantial burden on very 
small plans.
    Covered entities under the genetic privacy and 
confidentiality standards of this legislation are subject to 
the same penalties and enforcement structure that exist for the 
HHS privacy regulations under sections 1176 and 1177 of the 
Social Security Act.
    The Secretary of HHS has the exclusive authority to enforce 
the privacy requirements of this section. As a result, 
enforcement of this legislation, with respect to a specific 
entity, may be split. For instance, for a group health plan, 
the Department of Labor will enforce the insurance 
discrimination provision under section 101 of this bill, but 
HHS will enforce the requirements of this section. The 
committee believes that, given that this provision is 
inextricably linked to the medical privacy rules, HHS is 
ideally situated to enforce these provisions against all 
covered entities. Moreover, HHS's ability to enforce this 
section is further bolstered by its expertise in the medical 
privacy regulations, the fact that the agency is already 
enforcing in this area, and the fact that the agency has 
assigned the HHS Office of Civil Rights to focus on privacy 
enforcement.
    Long-term care insurance is not intended to be subject to 
section 104. Since benefits for long-term care are ``excepted 
benefits'' under section 733(c)(2)(B) of ERISA, section 
2791(c)(2)(B) of the PHSA, and section 9832(c)(2)(B) of the 
IRC, it has never been the intent of the bill to subject long-
term care insurance to any of the bill's prohibitions with 
respect to health insurance discrimination on the basis of 
genetic information or genetic services. ``Excepted benefits,'' 
including benefits for long-term care, are not subject to the 
provisions of sections 101 or 102 which track the HIPAA 
framework that exempts ``excepted benefits'' from its 
substantive provisions. Accordingly, long-term care insurance 
is not subject to section 104.

                          Title II--Employment


Sec. 201. Definitions

    As a guiding principle, the Genetic Information 
Nondiscrimination Act of 2003 is designed to extend to 
individuals in the area of genetic discrimination the same 
procedures and remedies as are provided under Title VII of the 
Civil Rights Act of 1964, as amended. These individuals include 
employees and applicants working in the private sector, in 
Federal and State governments (including presidential and 
gubernatorial appointees), as well as congressional employees. 
The corresponding employers of these individuals, as well as 
employment agencies, labor organizations, and joint labor-
management committees are covered by the legislation in the 
same manner as current law.
    As in title I of the legislation, ``genetic information'' 
is defined as information about an individual's or family 
member's genetic tests, or information about the occurrence of 
a disease or disorder in family members of the individual. 
Likewise, ``genetic test'' is defined in the same way under 
titles I and II, except that the Employment title does not 
include an exception for an analysis that is directly related 
to a manifested disease, disorder, or pathological condition. 
In making this distinction, the committee recognizes there are 
important and necessary uses for non-genetic health information 
in the health insurance setting that are not applicable in the 
employment context.
    Section 210 specifically provides that the parties ``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.''
    As stated in the discussion of title I, the committee 
realizes that a family medical history could be used as a 
surrogate for genetic traits by a health plan or health 
insurance issuer. A consistent history of a heritable disease 
in a patient's family may be viewed to indicate that the 
patient himself or herself is at increased risk for that 
disease. For this reason, the Committee believes it is 
important to include family medical history in the definition 
of ``genetic information.'' In so doing, the committee followed 
the recommendations of numerous leading experts in genetic 
science. Further, the bill applies to spouses and adopted 
children of an individual because of the potential 
discrimination an employee or member could face because of an 
employer's or other entities' concern over potential medical or 
other costs and their effect on insurance rates.

Secs. 202-205. Prohibited practices

    Generally, employers, labor organizations, employment 
agencies, and joint labor-management committees are prohibited 
from using, acquiring or disclosing the genetic information of 
an individual or his/her family members.
    Use of Genetic Information: ``Use'' of genetic information, 
as drafted in the legislation, utilizes the language of Section 
703 of the Civil Rights Act of 1964, as amended, and the same 
forms of discriminatory acts are outlawed. These acts include 
refusing to hire or discharging a person based on the genetic 
information including family history of disease. For example, 
it would be unlawful for an employer to refuse to hire an 
otherwise healthy applicant because of a fear that he may 
develop Parkinson's disease because of a family history of such 
disease. The prohibition also extends to limiting, segregating, 
or classifying an individual in a way that would deprive him or 
her of employment opportunities.
    Acquisition of Genetic Information: Banning the use of 
genetic information alone would not reach the full range of 
serious concerns that the Genetic Information Nondiscrimination 
Act is seeking to address. The committee recognizes that the 
fear of misuse of genetic information and privacy concerns 
deter individuals from being tested for genetic disorders, 
seeking genetic services, or participating in important genetic 
research. Scientific advances in the field of genetics hold 
great promise for medical prevention and new treatments and 
therapies. As a matter of sound public policy, the committee is 
concerned that this promise will go unfulfilled if individuals 
are afraid to get genetic tests or seek genetic counseling out 
of fear that they will face discrimination in their employment.
    To this end, the legislation makes it unlawful for an 
employer, labor organization, employment agency, or joint 
labor-management committee to request, require, or purchase 
genetic information, except under limited circumstances. Most 
notably, this prohibition addresses the concerns raised in the 
case against Burlington Northern Santa Fe Railroad. The 
company, allegedly without employees' consent or knowledge, 
conducted genetic tests on blood samples it had previously 
received from some workers. The U.S. Equal Employment 
Opportunity Commission filed suit against the company under the 
Americans with Disabilities Act, relying on the third prong of 
the definition of ``disability'' as ``being regarded as having 
such an impairment.'' The case was ultimately settled so the 
courts have not had the opportunity to interpret the full 
application of the ``regarded as'' prong to genetics 
discrimination.
    The committee's decision to include a prohibition against 
acquiring genetic information was informed by witnesses who 
appeared before us, and existing law and regulations. Witnesses 
at the committee hearing on February 13, 2002, stressed the 
need to avoid unintended consequences and to anticipate the 
requirements of existing employment statutes in order to avoid 
conflicts. The committee has carefully considered the existing 
laws and regulations that touch on the flow of information in 
the workplace and incorporated five exceptions.
    The first exception addresses the so-called ``water cooler 
problem,'' in which an employer unwittingly receives otherwise 
protected genetic information in the form of family medical 
history through casual conversations with a worker. The 
committee recognizes that conversations among co-workers about 
the health of a family member are common and intends to prevent 
such normal interaction from becoming the basis of litigation 
under this Act. Without the exception, the committee is 
concerned that discussion in the workplace of a family member's 
health condition that is genetically based could be interpreted 
as an employer requesting or requiring genetic information from 
an individual. Under the legislation, an employer, labor 
organization, employment agency, or joint labor-management 
committee will not violate the ban on acquiring genetic 
information where it ``inadvertently requests or requires 
family medical history'' of the individual or family member of 
the individual.
    The second exception--which preserves employer-sponsored 
wellness programs--is necessary to achieve the bill's stated 
goal of encouraging employees to take advantage of genetic 
technologies and opportunities to improve human health without 
fear of discrimination by their employer. To qualify for the 
exception, this program must be a wellness program as defined 
under section 702 of ERISA. Participation in the program must 
be voluntary and confidential, and safeguards must be in place 
to ensure that the sponsoring employer, labor organization, 
employment agency, or joint labor-management committee does not 
have access to individually identifiable health information, as 
defined under the HHS medical privacy regulations.
    The committee is concerned that restrictions on information 
about the health condition of a family member would conflict 
with the certification procedures under Federal and State 
family and medical leave laws. For example, an employee seeking 
time off to care for a sick family member may be required to 
certify the request with a note from the treating physician. 
The doctor's note may contain genetic information, which is 
defined for the purposes of this legislation to include family 
medical history. The third exception eliminates the potential 
for conflict with existing laws by exempting requests or 
requirements for family medical history when sought ``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.''
    The committee recognizes that family medical history can 
easily and inadvertently be obtained. The fourth exception, 
like the first, relates to the inadvertent acquisition of 
family medical history. The committee is concerned that the 
proscriptions of the legislation would be violated, for 
example, through the purchase of a local newspaper containing 
the obituary of an employee's parent who died of breast cancer. 
This exception was included to satisfy the principle in the 
bill that the rules be clear and that the bill not provide a 
basis for frivolous claims. Specifically, the fourth exception 
provides an exemption where an employer, labor organization, 
employment agency, 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.'' In referring to 
``documents,'' the committee is mindful of Rule 34 of the 
Federal Rules of Civil Procedure that includes the same 
materials that are electronically available.
    The final exception to the rule against requesting, 
requiring, or purchasing genetic information protects genetic 
monitoring of biological effects of toxic substances in the 
workplace, but only in limited circumstances. The employer, 
labor organization, employment agency, or joint labor-
management committee must give written notice. Unless the 
monitoring is required by Federal or State law, the individual 
must provide prior, knowing, voluntary and written 
authorization. The individual must be provided the results of 
the monitoring. The monitoring must be conducted in compliance 
with any genetic monitoring regulations, whether promulgated 
under the Occupational Safety and Health Act (or its state 
equivalent), the Federal Mine Safety and Health Act, or the 
Atomic Energy Act. Finally, the monitoring results may only be 
disclosed to the employer, labor organization, employment 
agency, or joint labor-management committee in the aggregate 
and where no individually identifiable information is included.
    Regardless of whether an exception applies, the bill makes 
clear that genetic information, once acquired, may not be used 
or disclosed in violation of the legislation.

Sec. 206. Confidentiality of genetic information

    Faced with concerns about the disclosure of confidential 
genetic information, individuals may not take advantage of 
genetic tests, services or counseling, or participate in 
genetic research. The committee believes that there are very 
few instances when an employer, labor organization, employment 
agency, or joint labor-management committee would have a 
legitimate need to divulge the genetic information that may be 
in its possession. The legislation adopts the general rule that 
such information shall be maintained on separate forms and in 
separate medical files and be treated as a confidential medical 
record. This is consistent with the ADA's requirements 
regarding the maintenance and treatment of medical information.
    Also as a general rule, an employer, labor organization, 
employment agency, or joint labor-management committee is 
prohibited under this legislation from disclosing genetic 
information. Both for practical reasons and in order not to 
subject these entities to conflicting legal obligations, five 
exceptions have been included in the legislation. The genetic 
information may be provided directly to an individual who 
receives genetic services. The information may also be 
disclosed to an occupational or health researcher for research 
in compliance with 45 CFR Part 46, in response to a court order 
(with certain limitations), to government officials 
investigating compliance with this title, and in connection 
with Federal or State family and medical leave certification 
provisions. The committee does not intend for this section to 
bar law enforcement authorities from conducting forensic 
analysis of DNA samples in their lawful possession for law 
enforcement purposes, nor to interfere with legitimate law 
enforcement functions, such as searches conducted pursuant to a 
warrant, acquisition of DNA samples pursuant to a legitimate 
court order (subject to the limitations in section 206(b)(3)), 
or analyses of DNA samples stored in repositories maintained by 
law enforcement authorities.

Sec. 207. Remedies and enforcement

    The committee recognizes that an effective remedial scheme 
and proper enforcement are a necessary element in ensuring that 
the protections in this legislation are realized in the 
workplace.\17\
---------------------------------------------------------------------------
    \17\ The advisability of applying existing administrative 
procedures to genetic discrimination claims was best described by Cari 
M. Dominguez, Chair of the U.S. Equal Employment Opportunity Commission 
in testimony before the committee: ``We at the EEOC feel that the EEOC 
has an established and familiar administrative procedure, including a 
well-received mediation program, which has proven successful in 
resolving discrimination charges swiftly, to the satisfaction of all 
parties, and without litigation. * * * Where the EEOC finds cause to 
believe that discrimination has occurred, we have a conciliation 
procedure through which many charges are also resolved. Because it 
provides incentives and opportunities for settlement, the 
administrative process is much less costly and burdensome, both to 
those involved and to the judicial system, than a process that would 
permit immediate access to the courts. Moreover, during the past 
several years, the Commission has made changes to charge processing, 
enabling us to keep up with our current caseload as well as reduce our 
charge backlog. EEOC also has expertise in the development of 
employment nondiscrimination enforcement policies that shield workers 
from unlawful discrimination and ensure that legitimate needs are 
met.''

    To this end, the committee has taken advantage of the expertise and 
process of the EEOC. The legislation protects applicants or employees 
of employers defined under the Civil Rights Act of 1964, 42 U.S.C. 
2000e(f), State employees, Federal employees, congressional employees, 
and employees as defined in 3 U.S.C. 411(c). Claimants are required to 
file a charge with the appropriate enforcement agency, within a certain 
time period, prior to filing a suit in court. The bill provides for the 
same compensatory and punitive damages available to prevailing 
plaintiffs under 42 U.S.C. 1981a.

    Because the legislation expressly covers State employees, 
the committee wishes to review the record of State 
discrimination in genetics. Based on early genetic science, 
States enacted laws that provided for the sterilization of 
``undesirable'' 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. 
In the years following, many States enacted legislation that 
either incorporated provisions or drew inspiration from the 
first sterilization law. 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.
    The Supreme Court's earliest decision on the 
constitutionality of State sterilization statutes certainly 
does not reflect contemporary norms, but the case has never 
been officially overruled by the Court. Skinner v. Oklahoma, 
316 U.S. 535 (1942). 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.

Sec. 208. Disparate impact

    Due to the unique nature of genetic information and our 
current understanding of this developing area of science, the 
committee has determined that only disparate treatment cases 
should be permitted under this legislation at this time. The 
bill contemplates that the science could change in the future 
and has called for the creation of a study commission 6 years 
after the date of enactment to review this issue. The 
Commission's purpose is to advise Congress on the advisability 
of providing for a disparate impact cause of action in the 
future.

Sec. 209. Construction

    As stated previously, it is the committee's intent to 
provide clear rules of conduct to all parties in order to 
promote compliance and avoid needless or frivolous lawsuits. In 
most instances, the legislation is designed to work in 
conjunction with existing laws and not to override current 
protections, rights, or defenses. Several rules of construction 
have been included in the legislation to assist courts in 
interpreting congressional intent.
    The committee recognizes that both the ADA and the 
Rehabilitation Act of 1973 regulate the use of genetic 
information in some manner. The first rule of construction 
expressly states that nothing in title II shall be construed to 
limit the rights or protections of an individual under those 
two laws. Individuals remain free to seek redress for 
violations of the ADA, the Rehabilitation Act, and the Genetic 
Information Nondiscrimination Act. The committee emphasizes, 
however, that this legislation in no way alters the current law 
prohibiting double recovery of damages based on the same facts 
or a common occurrence. See, e.g., Anderson v. Group 
Hospitalization, 820 F.2d 465 (D.C. Cir. 1987); Skinner v. 
Total Petroleum, 859 F.2d 1439 (10th Cir. 1988); Kim v. Nash, 
123 F.3d 1046 (8th Cir. 1997); Atkinson v. Anadarko Bank and 
Trust Company, 808 F.2d 438, 441 (5th Cir.) cert. denied 483 US 
1032 (1987); Squires v. Bonser, 54 F.3d 168 (3d Cir. 1995); and 
Mason v. Oklahoma Turnpike Authority, 115 F. 3d 1442 (10th Cir. 
1997).
    The second rule of construction is included to ensure that 
claims against parties are brought in the capacity in which 
they act. The committee recognizes that an employer, labor 
organization, employment agency, or joint labor-management 
committee can act in its capacity as an employer, or in its 
capacity under ERISA as a plan sponsor, fiduciary, or plan 
administrator. The actions of an employer, labor organization, 
employment agency, or joint labor-management committee when 
taken in its capacity as a plan sponsor, fiduciary, or plan 
administrator, would be governed by title I of this 
legislation. Currently, courts must decide whether conduct of 
an employer violates ERISA or title VII of the Civil Rights Act 
of 1964, depending on whether the employer was acting in its 
capacity as a group health plan or as an employer, 
respectively. The committee does not intend to extend liability 
under title II, where broader remedies may be more attractive 
than the remedies under title I, for violations of title I. The 
legislation should not be interpreted to change current law and 
courts will continue to evaluate the facts in light of existing 
precedent.
    The third rule of construction reiterates that the Genetic 
Information Nondiscrimination Act serves as a Federal floor for 
genetics rights and does not pre-empt Federal and State laws 
that provide equal or greater protections to individuals. This 
follows the long line of Federal employment, wage and hour, and 
other laws. The remaining rules of construction make clear that 
this legislation shall not be construed to interfere with the 
normal operation of several existing statutes and programs; 
specifically, these are the Armed Forces Repository of Specimen 
Samples for the Identification of Remains, applicable workers' 
compensation laws, occupational and other health research 
pursuant to 45 C.F.R. Part 46, and regulatory actions by the 
Occupational Safety and Health Administration and the Mine 
Safety and Health Administration.

                            V. Cost Estimate

                                                    March 28, 2007.
Hon. Edward M. Kennedy,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 358, the Genetic 
Information Nondiscrimination Act of 2007.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Shinobu 
Suzuki.
            Sincerely,
                                                   Peter R. Orszag.
    Enclosure.--

S. 358--Genetic Information Nondiscrimination Act of 2007

    S. 358 would amend the Employee Retirement Income Security 
Act of 1974 (ERISA), the Public Health Service Act, and Title 
XVIII of the Social Security Act to prohibit the use of genetic 
information (including results of genetic tests and family 
history of disease) by employers in employment decisions and by 
health insurers and health plans in making enrollment 
determinations and setting insurance premiums.
    CBO estimates that enacting the bill would increase the 
number of individuals who obtain health insurance by about 600 
people per year, nearly all of whom would obtain insurance in 
the individual market. The bill would affect federal revenues 
because the premiums paid by some of those newly insured 
individuals would be tax-deductible.
    CBO estimates that enacting S. 358 would reduce revenues by 
less than $500,000 in each year from 2008 through 2017, by $1 
million over the 2008-2012 period, and by $2 million over the 
2008-2017 period. (These estimates include reductions in off-
budget receipts from Social Security payroll taxes of less than 
$500,000 over the 2008-2012 period, and slightly less than $1 
million over the 2008-2017 period.) The bill's requirements 
would apply to Medicare Supplemental Insurance, which could 
affect direct spending for Medicare. However, we estimate that 
the bill would have no significant effect on direct spending.
    The bill would require the Secretaries of Health and Human 
Services (HHS), Labor, and the Treasury to issue regulations to 
carry out the provisions of this bill, and would require the 
Secretaries of HHS and Labor to enforce those provisions. In 
addition, six years after enactment, the bill would establish a 
commission to review the science of genetics and to make 
recommendations to the Congress on the need to establish a 
disparate impact standard for genetic discrimination. The bill 
would authorize the appropriation of such sums as necessary to 
establish the commission and to carry out the other provisions 
of the bill. Assuming the appropriation of the necessary 
amounts, CBO estimates that implementing S. 358 would increase 
discretionary spending by less than $500,000 in 2008 and by $2 
million over the 2008-2017 period.
    S. 358 would restrict how State and local governments use 
genetic information in employment practices and in the 
provision of health care to employees. That limitation on state 
and local actions would be an intergovernmental mandate as 
defined in the Unfunded Mandates Reform Act (UMRA), but there 
is little indication that state, local, or tribal governments 
currently engage in or are likely to engage in the activities 
that would be prohibited by the bill. Consequently, CBO 
estimates that the costs of the mandates would not be 
significant and would not exceed the threshold established in 
UMRA ($66 million in 2007, adjusted annually for inflation).
    The bill contains private-sector mandates on health 
insurers, health plans, employers, labor unions, and other 
organizations. CBO estimates that the direct cost of those 
requirements would not exceed the annual threshold specified in 
UMRA ($131 million in 2007, adjusted annually for inflation) in 
any of the first five years the mandates would be effective.
    The CBO staff contacts for this estimate are Shinobu Suzuki 
(for federal costs); Leo Lex (for the State and local impact), 
and David Auerbach (for the private-sector impact). This 
estimate was approved by Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

            VI. Application of Law to the Legislative Branch

    Section 102(b)(3) of Public Law 104-1, the Congressional 
Accountability Act (CAA), requires a description of the 
application of this bill to the legislative branch. S. 358 
prohibits discrimination on the basis of genetic information 
with respect to health insurance and employment. With respect 
to health insurance, the provisions of S. 358 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. Through 
the CAA, these laws, and S. 358, would be applicable to the 
legislative branch.

                    VII. Regulatory Impact Statement

    The committee has determined that there will be minimal 
increases in the regulatory burden imposed by this bill.
    Title I of the bill generally builds on existing regulatory 
structures and industry practices. It is composed of several 
sections and applies to group health plans, group health 
insurance, insurers in the individual market, and issuers of 
Medicare supplemental policies. All non-governmental and many 
non-Federal, State and local governmental group health plans 
are subject to existing protections under ERISA, PHSA, and IRC 
that pertain to discrimination based on health-status. These 
plans are also currently subject to the HHS medical privacy 
rules. While the legislation adds to the substance of these 
existing requirements, it does not add any major new concepts 
or requirements, such as a notice requirement. Based on these 
factors, the committee has determined that there will be 
negligible regulatory impact with respect to group health 
plans.
    Although insurance issuers of Medicare supplemental 
policies and individual policies are not subject to Federal law 
banning genetic discrimination, many States have already passed 
laws in this area. In addition, the majority of these issuers 
are currently subject to the HHS medical privacy rules. Thus, 
the committee has determined that there will be minimal 
regulatory burden imposed with respect to insurance issuers 
Medicare supplemental policies and individual policies.

                   VIII. Section-by-Section Analysis


        Title I--Genetic Non-Discrimination in Health Insurance


Sec. 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
    Sec. 101(a)(1)--No Enrollment Restriction for Genetic 
Services. This provision 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.''
    Sec. 101(a)(2)--No Discrimination in Group Premiums Based 
on Genetic Information. This provision 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.
    Sec. 101(b)--Limitations on Genetic Testing. This section 
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 wellness program (as defined under regulations 
promulgating ERISA Section 702 at 29 CFR 2590.702(f)) 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. 
Therefore, 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. This section 
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.
    (1) Injunctive Relief for Irreparable Harm--This provision 
clarifies that an ERISA plan participant or beneficiary can 
seek relief in court under Section 502(a)(1)(B) of ERISA for a 
violation of the amendments made by section 101 of this Act, 
prior to the exhaustion of the plan's administrative remedies 
under Section 503 of ERISA. To qualify for such relief, a 
participant or beneficiary must demonstrate to the court, by a 
preponderance of evidence, that the exhaustion of 
administrative remedies would cause irreparable harm to the 
health of such participant or beneficiary. Any determinations 
made, either previously or while an action under this provision 
is pending, under the plan's administrative remedies shall be 
given due consideration by the court.
    (2) Equitable Relief for Genetic Discrimination--This 
provision clarifies and expands the type of equitable relief 
and penalties available under Section 502 of ERISA for a 
violation of this Section.
    (A) Reinstatement of Benefits Where Equitable Relief Has 
Been Awarded--If a participant or beneficiary recovers benefits 
under Section 502(a)(1)(B) of ERISA for a violation of the 
amendments made by section 101 of this Act, this provision 
allows the court, in its discretion, to reinstate coverage 
retroactively. Specifically, where a participant or beneficiary 
has been wrongfully denied eligibility under the plan due to a 
violation of such section, the court can award reinstatement of 
a participant's or beneficiary's coverage, retroactive to the 
date of the denial of such eligibility.
    (B) Administrative Penalty Where Equitable Relief Has Been 
Awarded--If a participant or beneficiary recovers benefits 
under Section 502(a)(1)(B) for a violation of the amendments 
made by section 101 of this Act, this provision allows the 
court, in its discretion, to levy a penalty on the 
administrator who fails to comply with the requirements of this 
title. Such administrator can be held personally liable for a 
penalty in the amount of not more than $100 for each day in the 
non-compliance period. Such penalty shall be payable to the 
participant or beneficiary involved. The non-compliance period 
is defined as the period beginning on the date that the 
failure, a violation of any of the provision of this Section, 
occurs and ending on the date that such failure is corrected.
    (3) Secretarial Enforcement Authority--Under current law, 
HIPAA's existing nondiscrimination provisions are enforced by 
the personal remedies available under ERISA 502(a)(1) or (3). 
In addition, the Department of the Treasury and Internal 
Revenue Service may levy an excise tax against a group health 
plan for its failure to comply with HIPAA's requirements. The 
Department of Labor is not currently authorized to impose 
penalties for HIPAA violations. This provision maintains the 
size and framework of the HIPAA excise tax, but transfers the 
enforcement authority to the Department of Labor solely for the 
purposes of enforcing this section.
    Amount of Penalty--Specifically, the Secretary of Labor may 
impose a civil penalty against a group health plan for any 
violation of this Section in the amount of $100 for each day in 
the noncompliance with respect to each individual to whom such 
failure relates. A higher penalty of $2,500 for each day of 
noncompliance shall be applied where there is one or more 
failure 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.
    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. A 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.
    Sec. 101(d)--Definitions. This section adds new definitions 
to Section 733(d) of ERISA with respect to genetic 
nondiscrimination.
    Family Member--Means the spouse of the individual, a 
dependent child of the individual, and 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 
(such as obtaining, interpreting, or assessing genetic 
information); or genetic education.
    Sec. 101(e)--Regulations and Effective Date. The Secretary 
of Labor shall issue final regulations not later than 1 year 
after enactment. The amendments made by this act shall apply to 
group health plans for plan years beginning 18 months after 
enactment.

Sec. 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--Section 2702(a)(1)(F) 
and 2702(b) of the Public Health Service Act currently 
prohibits 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.
    (A) No Enrollment Restriction for Genetic Services--This 
provision clarifies 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 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.
    (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 
promulgating 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 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 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. 
Therefore, 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 applies to 
retiree-only group health plans (and group health insurance 
coverage offered in connection with a group health plan).
    (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 nondiscrimination provisions against health 
insurance issuers offering group health insurance coverage in 
connection with a group health plan under section 2702 of the 
PHSA. In general, a State may require health insurance issuers 
to meet the requirements of HIPAA. If a State fails to 
substantially enforce a provision with respect to health 
insurance issuers, the Secretary of HHS shall enforce.
    Secretarial 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--Specifically, 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 in the non-compliance 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 failure 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 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 
nondiscrimination. The definitions are identical to the 
definitions applying to group health plans under section 101.
            Subsection (b). Amendments Relating to the Individual 
                    Market
    (b)(1). Adds a new section 2753 to subpart 2 to title XXVII 
of PHSA relating to genetic nondiscrimination.
    Sec. 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). This 
subsection also incorporates by reference the prohibition that 
currently applies under section 2701(b)(1)(B) of the Public 
Health Service Act to a group health plan and a health 
insurance issuer offering coverage in the group market against 
treating genetic information as a pre-existing condition.
    Sec. 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).
    Sec. 2753(c)--Limitation on 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 
promulgating 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.
    (2) Remedies and Enforcement.--This section amends section 
2761 of 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 
nondiscrimination 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 
nondiscrimination 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 1 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 enactment of this title. The amendments made by this 
section shall apply to insurance in the individual market 18 
months after date of enactment.

Sec. 103. Amendments to Title XVIII of the Social Security Act Relating 
        to Medigap

            Subsection (a). Nondiscrimination
    Sec. 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).
    Sec. 103(a)(2)--Effective Date. Prohibition in (a)(1) 
applies for policy years beginning after the date that is 18 
months after the date of enactment.
    Sec. 103(b)(1)--Limitation on Genetic Testing. This 
provision amends 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 (as defined under regulations promulgating ERISA 
section 702) 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.
    Sec. 103(b)(2)--Conforming Amendment. The legislation 
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.
    Sec. 103(c)--Transition Provisions. The Secretary of HHS 
identifies whether a State needs to change its statute 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.

Sec. 104. Privacy and Confidentiality

    Sec. 104(a)--Applicability. The provisions in this section 
apply to all group health plans, health insurance issuers 
(including issuers offering coverage in connection with group 
health plans or individual health coverage), and issuers of 
Medicare supplemental policies as defined in previous sections 
of this Act and without any exception for small groups or a 
non-Federal governmental opt-out.
    Sec. 104(b). Compliance with Certain Confidentiality 
Standards with Respect to Genetic Information.
    (1) In General--The medical privacy rules promulgated by 
HHS (45 CFR Parts 160 and 164; final rule) shall apply to the 
use and disclosure of genetic information.
    (2) Prohibition on Underwriting and Premium Rating--As an 
exception to (1), a group health plan, health insurance issuer, 
or 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 to enroll, premium 
rating, or the creation, renewal or replacement of a plan, 
contract or coverage for health insurance or benefits.
    Sec. 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.
    Sec. 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.
    Sec. 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.
    Sec. 104(f)--Pre-emption. The pre-emption 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 as State law that is 
more stringent shall be pre-empted 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.
    Sec. 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.
    Sec. 104(h)(1)--Definitions. The definitions of ``family 
member,'' ``genetic information,'' ``genetic services,'' and 
``genetic test'' are identical to the definitions in section 
101 of this bill. However, a new definition of group health 
plan is included.
    (2) Group Health Plan/Health Insurance Issuer--These terms 
include only those plans and issuers that are otherwise covered 
under the HHS medical privacy regulations and under (d)(1) of 
this section.
    (3) Issuer of a Medicare Supplemental Policy--Means an 
issuer described in section 1882 of the Social Security Act.
    (4) Secretary--Means the Secretary of Health and Human 
Services.

Sec. 105. Assuring Coordination

    (a) The Secretary of Health and Human Services, and the 
Secretary of Labor 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.
    (b) The Secretary of Health and Human Services shall have 
sole authority over section 104, the privacy and 
confidentiality standards pertaining to genetic information.

Sec. 106. Regulations and Effective Date

    No later than 1 year after the date of enactment, the 
Secretaries of Labor and Health and Human Services shall issue 
final regulations. Except as provided in section 103 with 
respect to an issuer of a Medicare supplemental policy, the 
requirements of this act shall take effect 18 months after 
enactment.

                          Title II--Employment

    Sec. 201. Definitions. The section defines the parties 
covered by the act--employer, employment agency, labor 
organization--and ensures that State, Federal and congressional 
employees receive the same protections. Family members are 
defined as the spouse or dependent child of an individual, and 
all other individuals related by blood to the individual or 
his/her spouse or dependant child. 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. The section 
defines genetic monitoring, services and tests consistent with 
title I.
    Sec. 202. Employer Practices. An employer is prohibited 
from using genetic information to discriminate against an 
individual in employment. The section also 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.
    Sec. 203. Employment Agency Practices. This section extends 
parallel obligations and exceptions to employment agencies as 
apply to employers under sec. 202.
    Sec. 204. Labor Organization Practices. This section 
extends parallel obligations and exceptions to labor 
organizations as apply to employers under sec. 202.
    Sec. 205. Training Programs. This section extends parallel 
obligations and exceptions to joint labor-management committees 
as apply to employers under Sec. 202.
    Sec. 206. Confidentiality of Genetic Information. This 
section provides that an individual's genetic information shall 
be treated and maintained as part of the individual's 
confidential medical records. 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.
    Sec. 207. Remedies and Enforcement. The bill incorporates 
by reference the powers, remedies, and procedures set forth in 
title VII the Civil Rights Act of 1964, as amended. Similar 
powers, remedies and procedures are specified for State, 
Federal and congressional employees.
    Sec. 208. Disparate Impact. The bill prohibits claims based 
on disparate impact, and empanels a commission in 6 years to 
review the science of genetics and make recommendations to 
Congress regarding whether to provide a disparate impact cause 
of action under this act.
    Sec. 209. Construction. This section 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. 
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. The section clarifies that 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 
of an employee or member that is not genetic information, about 
a manifested disease, disorder or pathological condition that 
has or may have a genetic basis.
    Sec. 211. Regulations. The EEOC is charged with issuing 
final regulations under this title within 1 year of enactment.
    Sec. 212. Authorization of Appropriations. Such sums as may 
be necessary.
    Sec. 213. Effective Date. Eighteen months after enactment.

                   Title III--Miscellaneous Provision

    Sec. 301. Severability. If any provision of this act, or an 
amendment made by this Act, or the application of such 
provision or amendment is held to be unconstitutional, the 
remainder of this act shall not be affected.

                      IX. Changes in Existing Law

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (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

           *       *       *       *       *       *       *


    Sec. 502. (a) A civil action may be brought--
    (l) * * *

           *       *       *       *       *       *       *

    (m) * * *
  (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.

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

    (a) In Eligibility To Enroll.--
          (1) In general.* * *
                  (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) In general.--* * *
          (2) Construciton.--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 of 
        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 subsection 
(a)(1)(F), (b)(3), and (c) shall apply to group health plans 
and health insurance issuers without regard to section 732(a).

           *       *       *       *       *       *       *


SEC. 733. DEFINITIONS.

    (a) Group Health Plan.--
          (1) In general.--* * *

           *       *       *       *       *       *       *

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

           *       *       *       *       *       *       *

          (4) * * *
          (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

           *       *       *       *       *       *       *



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

    (a) In Eligibility To Enroll.--
          (1) In general.--* * *
                  (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) In general.--* * *
          (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 2721(a).

SEC. 2721. EXCLUSION OF CERTAIN PLANS.

    (a) Exception for Certain Small Group Health Plans.--* * *
    (b) Limitation on Application of Provisions Relating to 
Group Health Plans.--
          (1) In general.--* * *

           *       *       *       *       *       *       *

          (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) State Enforcement.--
          (1) State authority.--* * *

           *       *       *       *       *       *       *

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

           *       *       *       *       *       *       *

          (2) * * *

           *       *       *       *       *       *       *

          (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.
                  (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.

           *       *       *       *       *       *       *


                     Subpart 3--General Provisions

SEC. 2761. ENFORCEMENT.

    (a) State Enforcement.--
          (1) State authority.--

           *       *       *       *       *       *       *

  [(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.

           *       *       *       *       *       *       *


SEC. 2791. DEFINITIONS.

    (a) Group Health Plan.--
          (1) Definitions.--* * *

           *       *       *       *       *       *       *

    (d) Other Definitions.--
          (1) Applicable state authority.--* * *

           *       *       *       *       *       *       *

          (14) * * *
          (15) 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).
          (16) 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.
          (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.

           *       *       *       *       *       *       *


    TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE


                      Part A--Group Market Reforms


Subpart 1--Portability, Access, and Renewability Requirements

           *       *       *       *       *       *       *



                    Part B--Individual market Rules


Subpart 1--Portability, Access, and Renewability Requirements

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                   Subpart [3] 2--Other Requirements


SEC. 2751. STANDARDS RELATING TO BENEFITS FOR MOTHERS AND NEWBORNS.

    (a) In General.--* * *

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SEC. 2752. REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING 
                    MASTECTOMIES.

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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) Genetic Testing.--
          (1) Limitation on requesting or requiring genetic 
        testing.--A health insurance issuer offering health 
        insurance coverage in the individual market shall not 
        request or require an individual or a family member of 
        such individual to undergo a genetic test.
          (2) Rule of construction.--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.

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SOCIAL SECURITY ACT

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SEC. 1882.

    (a)(1) * * *

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

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

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    (s)(1) * * *

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    (2)(A) * * *

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    (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).

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    (w) 625 Development of New Standards for 
Medicare Supplemental Policies.--
          (1) In general.--

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    (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.

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