[Federal Register Volume 74, Number 193 (Wednesday, October 7, 2009)]
[Rules and Regulations]
[Pages 51664-51697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22504]
[[Page 51663]]
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Part II
Department of the Treasury
Internal Revenue Service
26 CFR Part 54
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Department of Labor
Employee Benefits Security Administration
29 CFR Part 2590
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Department of Health and Human Services
Centers for Medicare & Medicaid Services
45 CFR Parts 144, 146, and 148
Office of the Secretary
45 CFR Parts 160 and 164
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Prohibiting Discrimination Based on Genetic Information; Interim Final
Rules; HIPAA Administrative Simplification; Genetic Information
Nondiscrimination Act; Proposed Rules
Federal Register / Vol. 74 , No. 193 / Wednesday, October 7, 2009 /
Rules and Regulations
[[Page 51664]]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD 9464]
RIN 1545-BI03
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AB27
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
45 CFR Parts 144, 146, and 148
RIN 0938-AP37
Interim Final Rules Prohibiting Discrimination Based on Genetic
Information in Health Insurance Coverage and Group Health Plans
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Interim final rules with request for comments.
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SUMMARY: This document contains interim final rules implementing
sections 101 through 103 of the Genetic Information Nondiscrimination
Act of 2008. These provisions prohibit discrimination based on genetic
information in health insurance coverage and group health plans.
DATES: Effective Date: These interim final regulations are effective on
December 7, 2009.
Comment Date. Comments are due on or before January 5, 2010.
Applicability Dates: Group market rules. These interim final
regulations for the group market apply to group health plans and group
health insurance issuers for plan years beginning on or after December
7, 2009.
Individual market rules. These interim final regulations for the
individual market apply with respect to health insurance coverage
offered, sold, issued, renewed, in effect, or operated in the
individual market on or after December 7, 2009.
ADDRESSES: Written comments may be submitted to any of the addresses
specified below. Any comment that is submitted to any Department will
be shared with the other Departments. Please do not submit duplicates.
Department of Labor. Comments to the Department of Labor,
identified by RIN 1210-AB27, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected].
Mail or Hand Delivery: Office of Health Plan Standards and
Compliance Assistance, Employee Benefits Security Administration, Room
N-5653, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210, Attention: RIN 1210-AB27.
Comments received by the Department of Labor will be posted without
change to http://www.regulations.gov and http://www.dol.gov/ebsa, and
available for public inspection at the Public Disclosure Room, N-1513,
Employee Benefits Security Administration, 200 Constitution Avenue,
NW., Washington, DC 20210, including any personal information provided.
Department of Health and Human Services (HHS). Comments to HHS,
identified by CMS-4137-IFC, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Centers for Medicare & Medicaid Services, Department
of Health and Human Services, Attention: CMS-4137-IFC, P.O. Box 8017,
Baltimore, MD 21244-8010.
Hand or courier delivery. Comments may be delivered to
either 7500 Security Boulevard, Baltimore, MD 21244-1850 or Room 445-G,
Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington,
DC 20201. For delivery to Baltimore, please call telephone number (410)
786-7195 in advance to schedule your arrival with one of our staff
members. For delivery to Washington, because access to the interior of
the HHH Building is not readily available to persons without Federal
Government identification, commenters are encouraged to leave their
comments in the CMS drop slots located in the main lobby of the
building. A stamp-in clock is available for persons wishing to retain
proof of filing by stamping in and retaining an extra copy of the
comments being filed.
All submissions submitted to HHS will be available for public
inspection as they are received, generally beginning approximately
three weeks after publication of a document, at the headquarters for
the Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, MD 21244, Monday through Friday of each week from 8:30 a.m.
to 4 p.m. To schedule an appointment to view public comments, phone
(410) 786-7195.
Internal Revenue Service. Comments to the IRS, identified by REG-
123829-08, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: CC:PA:LPD:PR (REG-123829-08), Room 5205, Internal
Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC
20044.
Hand or courier delivery: Monday through Friday between
the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-123829-08),
Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue,
NW., Washington DC 20224.
All submissions to the IRS will be open to public inspection and
copying in room 1621, 1111 Constitution Avenue, NW., Washington, DC
from 9 a.m. to 4 p.m.
FOR FURTHER INFORMATION CONTACT: Amy Turner, Employee Benefits Security
Administration, Department of Labor, at (202) 693-8335. Russ
Weinheimer, Internal Revenue Service, Department of the Treasury, at
(202) 622-6080. Adam Shaw, Centers for Medicare & Medicaid Services,
Department of Health and Human Services, at (877) 267-2323, extension
61091.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor concerning employment-based
health coverage laws, including the nondiscrimination protections, may
call the EBSA Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the
Department of Labor's Web site (http://www.dol.gov/ebsa). In addition,
individuals may request a copy of CMS's publication entitled
``Protecting Your Health Insurance Coverage'' by calling 1-800-633-
4227.
SUPPLEMENTARY INFORMATION:
I. Background
The Genetic Information Nondiscrimination Act of 2008 (GINA),
Public Law 110-233, was enacted on May 21, 2008. Title I of GINA
amended the Employee Retirement Income Security Act of 1974 (ERISA),
the Public Health Service Act (PHS Act), the Internal Revenue Code of
1986 (Code), and the Social Security Act (SSA) to prohibit
discrimination in health coverage based on genetic information. GINA
builds on existing protections
[[Page 51665]]
added by titles I and IV of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA).\1\ Specifically, the HIPAA
portability provisions already prohibit a group health plan or group
health insurance issuer from imposing a preexisting condition exclusion
based solely on genetic information. See the 2004 final HIPAA
portability regulations, published in the Federal Register on December
30, 2004 (69 FR 78720). In addition, the HIPAA nondiscrimination
provisions already prohibit a group health plan or group health
insurance issuer from discriminating against an individual in
eligibility, benefits, or premiums based on genetic information (and
other health factors) of the individual or a dependent of the
individual. See the 2006 final HIPAA nondiscrimination regulations,
published in the Federal Register on December 13, 2006 (71 FR 75014).
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\1\ These HIPAA provisions generally apply to group health plans
and health insurance coverage in the group and individual markets.
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Sections 101 through 104 of Title I of GINA prohibit group health
plans, health insurance issuers in the group and individual markets,\2\
and issuers of Medicare supplemental (Medigap) policies from
discriminating based on genetic information, and from collecting such
information.\3\ Section 105 of Title I adds section 1180 of the SSA to
require HHS to revise the HIPAA privacy regulations to clarify that
genetic information is health information under the rule and to
prohibit the use or disclosure of genetic information for underwriting
purposes.\4\ Title II of GINA prohibits discrimination in employment
based on genetic information, and limits the acquisition and disclosure
by employers and other entities covered by GINA Title II of such
information.\5\ These interim final regulations only interpret Sections
101 through 103 of Title I of GINA, which added provisions to Subtitle
K of the Code, Part 7 of Subtitle B of Title I of ERISA, and Title
XXVII of the PHS Act.\6\ References to GINA in the remainder of this
preamble refer to the group market provisions of sections 101 through
103 of GINA, unless the context clearly indicates otherwise.
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\2\ Rules on GINA's application in the individual market are
solely within the jurisdiction of the Centers for Medicare &
Medicaid Services at the Department of Health and Human Services and
are discussed later in this preamble.
\3\ This regulation does not address the application of GINA to
Medigap issuers, which are subject to provisions in section 1882 of
the SSA that are implemented by the Centers for Medicare & Medicaid
Services (CMS), and incorporate by reference certain provisions in a
model regulation of the National Association of Insurance
Commissioners (NAIC). The model regulation adopted by the NAIC on
September 24, 2008 was published by CMS in the Federal Register on
April 24, 2009 at 74 FR 18808. This regulation also does not address
the additional enforcement authority given to the Secretaries of
Labor and HHS, relating to the use of genetic information, which
will be addressed in future regulatory guidance.
\4\ The HIPAA privacy provisions are administered by the Office
for Civil Rights within HHS, and will be the subject of a separate
rulemaking.
\5\ Title II of GINA is under the jurisdiction of the Equal
Employment Opportunity Commission, which issued a notice of proposed
rulemaking on March 2, 2009, 74 FR 9056.
\6\ Compliance with GINA sections 101 through 103 is not
determinative of compliance with any other provision of GINA or any
other State or Federal law, including the Americans with
Disabilities Act.
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On October 10, 2008, the Departments published in the Federal
Register (73 FR 60208) a request for information (RFI) soliciting
comments on the requirements of sections 101 through 104 of GINA. In
addition, the Departments consulted with and obtained technical
guidance from the scientific community, including the National Human
Genome Research Institute within the National Institutes of Health and
the Office for Human Research Protections, both within HHS. The
Departments also coordinated with the Equal Employment Opportunity
Commission (EEOC), which has responsibility for Title II of GINA, and
the Office for Civil Rights within HHS, which has responsibility for
section 105 of GINA.
After consideration of the comments received in response to the RFI
and based on the consultations with other government agencies, the
Departments are publishing these interim final regulations. For the
group market, these regulations become applicable to plans and issuers
on the first day of the plan year beginning on or after December 7,
2009. For the individual market, these regulations become applicable
with respect to health insurance coverage offered, sold, issued,
renewed, in effect, or operated in the individual market on or after
December 7, 2009.
II. Overview of the Regulations
A. Group Market
While GINA does not mandate any specific benefits for health care
services related to genetic tests, diseases, conditions, or genetic
services, GINA establishes rules that generally prohibit a group health
plan and a health insurance issuer in the group market from:
Increasing the group premium or contribution amounts based
on genetic information;
Requesting or requiring an individual or family member to
undergo a genetic test; and
Requesting, requiring or purchasing genetic information
prior to or in connection with enrollment, or at any time for
underwriting purposes.
These three general prohibitions are subject to rules of
construction or exceptions included in the statute which are discussed
in further detail later in this preamble.
1. Conforming Changes to Existing Regulations
Sections 9801 and 9802 of the Code, 701 and 702 of ERISA, and 2701
and 2702 of the PHS Act, as originally added by HIPAA, included
requirements pertaining to genetic information but did not define the
term. The 2004 final HIPAA portability regulations included a
definition of genetic information.
GINA contains a statutory definition of genetic information that
differs from the definition in the 2004 final HIPAA portability
regulations. These interim final regulations revise the existing
regulations' definition of genetic information at 26 CFR 54.9801-2, 29
CFR 2590.701-2, and 45 CFR 144.103, to conform to the new statutory
definition.
Sections 9802 of the Code, 702 of ERISA, and 2702 of the PHS Act,
and the 2006 final HIPAA nondiscrimination regulations prohibit
discrimination based on a health factor. GINA retained the prohibition
against increasing an individual's premium or contribution amounts
based on genetic information, and added a new provision to prevent
plans and issuers from adjusting premium or contribution rates at the
group level based on genetic information of one or more individuals in
the group. Therefore, these interim final regulations amend the 2006
regulations to add clarifying cross-references. See 26 CFR 54.9802-
1(c)(2)(i) and (iii), 29 CFR 2590.702(c)(2)(i) and (iii), and 45 CFR
146.121(c)(2)(i) and (iii).
2. Definitions
Paragraph (a) of these interim final regulations \7\ provides most
of the definitions used in GINA.\8\ Some of these definitions repeat
the statutory language, while others include regulatory clarifications.
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\7\ Because substantively similar regulation text is published
separately by the three Departments, and the section numbers will
all be different, the preamble refers only to the paragraph
designations within those sections.
\8\ The same definitions apply to the individual market
regulations under GINA, which are discussed later in this preamble,
to the extent that they are not inconsistent with respect to health
insurance coverage offered, sold, issued, renewed, in effect, or
operated in the individual market.
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[[Page 51666]]
a. Collect
The interim final regulations add the defined term ``collect.''
While ``collect'' was not defined in the statute, this term was added
to paraphrase the longer phrase ``request, require or purchase.'' Thus,
under the interim final regulations, ``collect'' means, with respect to
information, to request, require, or purchase such information.
b. Family Member
GINA adds a definition of family member to sections 9832 of the
Code, 733 of ERISA, and 2791 of the PHS Act. The definition of family
member determines the application of GINA in two ways. First, the
definition of genetic information for an individual includes
information about the manifestation of a disease or disorder in family
members of the individual. Also, a plan or issuer generally may not
request or require an individual or family member of the individual to
undergo a genetic test.
The statute defines a family member with respect to any individual
as a dependent of such individual (as such term is used for purposes of
sections 9801(f)(2) of the Code, 701(f)(2) of ERISA, and 2701(f)(2) of
the PHS Act (the dependent special enrollment rules)),\9\ and any other
individual that is a first-, second-, third-, or fourth-degree relative
of the individual or of the dependent of the individual. The
legislative history suggests that the term ``family member'' be broadly
construed: ``In general, it is intended that the term `family member'
be interpreted broadly so as to provide the maximum protection against
discrimination.'' House Report 110-28, Part 2 at 27.
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\9\ This definition of the term ``dependent'' is solely for
purposes of interpreting sections 101 through 103 of GINA, and is
not relevant to interpreting the term under Title II of GINA, which
is under the jurisdiction of the EEOC.
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Sections 9801(f)(2) of the Code, 701(f)(2) of ERISA, and 2701(f)(2)
of the PHS Act provide special enrollment rights to certain dependents
that are eligible for coverage under a group health plan due to such
family events as birth, adoption, or marriage. The statutory provisions
of neither HIPAA nor GINA define dependent, but the term is defined in
the 2004 final HIPAA portability regulations as any individual who is
or may become eligible for coverage under the terms of a group health
plan because of a relationship to a participant. This makes clear that
it is necessary to consult the plan document and other applicable law
to determine dependent status for purposes of GINA.
In determining who is a first-, second-, third-, or fourth-degree
relation of an individual, the interim final regulations treat
relatives by affinity (such as by marriage or adoption) the same as
relatives by consanguinity (relatives who share a common biological
ancestor, or blood relatives). The definition also treats relatives who
are not full blood relatives (such as half siblings) the same as full
blood relatives. In addition, the interim final regulations provide
non-exhaustive lists of individuals who are first-, second-, third-, or
fourth-degree relatives. The Departments invite public comments on this
definition.
c. Genetic Information
The interim final regulations contain a definition of genetic
information that restates and reorganizes the statutory provisions.
Genetic information is defined, with respect to an individual, as
information about the individual's genetic tests or the genetic tests
of family members, the manifestation of a disease or disorder in family
members of such individual (that is, family medical history), or any
request of or receipt by the individual or family members of genetic
services. The definition further clarifies that genetic information
does not include information about the sex or age of any individual. It
also clarifies how GINA applies to genetic information about a fetus or
embryo. As previously noted, this definition is a change from the
definition of genetic information that applied under the 2004 final
HIPAA portability regulations.
d. Genetic Services
An individual's genetic information includes any request for or
receipt of genetic services by such individual, or a family member.
These interim final regulations follow the statutory definition.
``Genetic services'' means a genetic test, genetic counseling, or
genetic education.
e. Genetic Test
GINA adds a definition of genetic test to sections 9832 of the
Code, 733 of ERISA, and 2791 of the PHS Act.\10\ These interim final
regulations repeat the statutory language, which provides that a
genetic test means an analysis of human DNA, RNA, chromosomes,
proteins, or metabolites, if it detects genotypes, mutations, or
chromosomal changes.
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\10\ This definition of the term ``genetic test'' is solely for
purposes of interpreting Title I of GINA, and is not relevant to
interpreting the term under Title II of GINA, which has a different
statutory definition.
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The interim final regulations also follow the statutory language
providing that a genetic test does not include 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 be reasonably detected by a health care
professional with appropriate training and expertise in the field of
medicine involved.
The interim final regulations include examples of certain tests
that currently are regarded as genetic or non-genetic tests, as the
case may be, based on research including consultations with
representatives from the scientific community. However, due to rapidly
evolving scientific knowledge, it is not an exhaustive list.
f. Manifestation or Manifested
The concept of manifestation of a disease arises in three contexts.
First, a plan or issuer may increase the premium or contribution amount
for a group health plan based on the manifestation of a disease or
disorder of an individual who is enrolled in the plan. Second, the
definition of genetic information for an individual includes
information about the manifestation of a disease or disorder in family
members of such individual. Finally, the definition of genetic test
excludes an analysis of proteins or metabolites that is directly
related to a manifested disease, disorder, or pathological condition
that could be reasonably detected by a health care professional with
appropriate training and expertise in the field of medicine involved.
The interim final regulations add a definition of manifestation or
manifested. A disease, disorder, or pathological condition is
manifested when an individual has been or could reasonably be diagnosed
by a health care professional with appropriate training and expertise
in the field of medicine involved. However, the definition further
provides that a disease, disorder, or pathological condition is not
manifested if a diagnosis is based principally on genetic information.
g. Underwriting Purposes
GINA includes a definition of underwriting purposes. This term is
discussed later in this preamble, in connection with the discussion of
the prohibition on collecting genetic information.
3. Prohibition on Adjusting Group Rates
GINA and these interim final regulations expand the HIPAA
prohibitions against discrimination
[[Page 51667]]
based on health factors, by prohibiting group health plans and health
insurance issuers offering health coverage in connection with a group
health plan from adjusting premium or contribution amounts for a group
health plan or group of similarly situated individuals on the basis of
genetic information. This is a change from prior law, which allowed
plans and issuers to adjust premium or contribution amounts for the
group health plan or a group of similarly situated individuals (but not
for individuals within the group) based on genetic information, as well
as other health factors. This prohibition against discrimination is
distinct from the prohibition on requesting or requiring an individual
to undergo a genetic test and the prohibition on collecting genetic
information. Therefore, even when a plan or issuer has lawfully
obtained genetic test results or other genetic information (for
example, an acquisition that took place prior to GINA's effective
date), the plan or issuer is still prohibited--under GINA and paragraph
(b) of these interim final regulations--from using that information to
discriminate.
GINA and these interim final regulations also provide that the
prohibition on adjusting premiums or contributions based on genetic
information does not limit the ability of a plan or issuer to increase
the premium or contribution amount for a group health plan based on the
manifestation of a disease or disorder of an individual enrolled in the
plan. However, a plan or issuer may not use the manifested disease or
disorder of one individual as genetic information about other group
members to further increase the premium or contribution amount.
Moreover, the prohibitions on adjusting premium or contribution amounts
based on genetic information do not prohibit a plan or issuer from
including costs associated with providing benefits for covered genetic
tests or genetic services within the costs of providing other benefits
in determining premiums or contribution amounts. In particular, a plan
or issuer is not required to reduce the aggregate costs of providing
health benefits for the year by those costs relating to benefits for
genetic tests and services when adjusting group rates. These interim
final regulations also make conforming changes to the existing HIPAA
nondiscrimination regulations regarding the ability to adjust premium
or contribution amounts based on a health factor.
4. Limitation on Requesting or Requiring Genetic Testing
GINA generally prohibits plans and issuers from requesting or
requiring individuals or their family members to undergo a genetic
test. There are three exceptions to this prohibition, for certain
health care professionals, for determinations regarding payment, and
for research.
The first exception allows a health care professional who is
providing health care services to an individual to request that the
individual undergo a genetic test. The health care professional must
actually be providing health care services to the individual for the
exception to apply. Thus, for example, the performance of claims review
by a health care professional would never be considered providing
health care services to an individual. The term ``health care
professional'' is not limited to physicians.
The second exception allows a plan or issuer to obtain and use the
results of a genetic test to make a determination regarding payment.
For this purpose, payment is defined by reference to 45 CFR 164.501 of
the HIPAA privacy regulations. However, plans and issuers are only
permitted to request the minimum amount of information necessary to
make this determination. These interim final regulations incorporate
the standard set forth at 45 CFR 164.502(b) of the HIPAA privacy
regulations to determine the minimum amount of information necessary.
In some cases, the appropriateness of certain courses of treatment
for a patient depends on the patient's genetic makeup. A plan or issuer
is permitted to condition payment for an item or service based on
medical appropriateness that depends on an individual's genetic makeup.
Under these narrow circumstances, a plan or issuer may condition
payment on the outcome of a genetic test, and may refuse payment for
the item or service if the individual does not undergo the genetic
test. Any information received by the plan to make a determination
regarding payment, including the results of a genetic test, must be
used in accordance with these interim final regulations and the 2006
final HIPAA nondiscrimination regulations.
Under the third exception relating to the limitation on requesting
or requiring genetic testing, a group health plan or group health
insurance issuer is permitted to request, but not require, that a
participant or beneficiary undergo a genetic test \11\ if all of the
following conditions of the research exception are satisfied:
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\11\ Comments indicated that at least one issuer is engaging in
a long-term research study involving genetic testing. Others may be
planning similar research.
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The request must be made pursuant to research that
complies with 45 CFR Part 46 (or equivalent Federal regulations) and
any applicable State or local law or regulations for the protection of
human subjects in research. Moreover, to comply with the informed
consent requirements of 45 CFR 46.116(a)(8), an investigator seeking
the informed consent of a human subject must provide the subject with a
statement that participation in the research is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is entitled, except in limited circumstances in which an
institutional review board has approved a waiver or alteration of this
requirement under the requirements of 45 CFR 46.116(c) or (d). For
research in which the investigator provides subjects with the statement
required under 45 CFR 46.116(a)(8) when seeking their informed consent,
no additional disclosures are required for purposes of the GINA
research exception.
The plan or issuer must make the request in writing and
must clearly indicate to each participant or beneficiary (or in the
case of a minor child, to the legal guardian of such beneficiary) to
whom the request is made that compliance with the request is voluntary
and noncompliance will have no effect on eligibility for benefits or
premium or contribution amounts.
None of the genetic information collected or acquired as a
result of the research may be used for underwriting purposes.
The plan or issuer must complete a copy of the ``Notice of
Research Exception under the Genetic Information Nondiscrimination
Act'' (the Notice) and provide it to the address specified in its
instructions. The Notice and instructions are available on the
Department of Labor's Web site (http://www.dol.gov/ebsa).
5. Prohibition on Collection of Genetic Information
Paragraph (d) of these interim final regulations describes the
statutory prohibitions against plans or issuers collecting genetic
information, either for underwriting purposes or prior to or in
connection with enrollment; sets forth the statutory definition of
underwriting purposes; and clarifies that, if an
[[Page 51668]]
individual seeks a benefit under a plan or coverage, the plan or
coverage may limit or exclude the benefit based on whether the benefit
is medically appropriate (and a determination of whether the benefit is
medically appropriate is not within the meaning of underwriting
purposes).
Underwriting purposes is defined under GINA and in these interim
final regulations as including, with respect to group health plan
coverage, rules for and determinations of eligibility (including
enrollment and continued eligibility), computation of premium or
contribution amounts, and application of preexisting condition
exclusions. Under GINA, the definition of underwriting is broader than
merely activities relating to rating and pricing a group policy. These
interim final regulations clarify that underwriting purposes includes
changing deductibles or other cost-sharing mechanisms, or providing
discounts, rebates, payments in kind, or other premium differential
mechanisms in return for activities such as completing a health risk
assessment (HRA) or participating in a wellness program.
GINA and paragraph (d) of the interim final regulations provide
that plans and issuers are only prohibited from collecting genetic
information for underwriting purposes or prior to or in connection with
enrollment. Where an individual seeks a benefit under the plan,
requesting family medical history or other genetic information to make
a determination whether the benefit is medically appropriate for
purposes of payment is neither for underwriting purposes nor prior to
or in connection with enrollment. Therefore, although the statutory
payment exception only applies to requests for individuals to undergo
genetic tests, these interim final regulations provide it is
permissible for a plan or issuer to request the minimum amount of
genetic information necessary to make determinations regarding payment.
Specifically, these interim final regulations provide that, if an
individual seeks a benefit under a plan or coverage, the plan or
coverage may limit or exclude the benefit based on whether the benefit
is medically appropriate, and the determination of whether the benefit
is medically appropriate is not within the meaning of underwriting
purposes. However, a plan or issuer is permitted to request only the
minimum amount of information necessary to determine medical
appropriateness.
These interim final regulations provide clarifications of the
statutory prohibition against a plan or issuer collecting genetic
information prior to or in connection with enrollment. Under the
interim final regulations, a collection of genetic information with
respect to an individual is considered prior to enrollment if it is
before the individual's effective date of coverage under the plan or
health insurance coverage. The determination of whether a plan or
issuer is collecting information before the individual's effective date
of coverage is made at the time of collection. Providing that the
determination is made at the time of collection means that if a plan or
issuer collects genetic information with respect to an individual in
circumstances that otherwise would not render the collection
impermissible and at that time it is not being collected in connection
with a future enrollment, the fact that a future enrollment may occur
does not mean, for purposes of this rule, that the genetic information
was collected before the enrollment. Thus, for example, if a plan
collected genetic information with respect to an individual after
initial enrollment (and not for underwriting purposes), and the
individual later dropped coverage but then still later reenrolled in
the plan, the collection of genetic information after the initial
enrollment would not be considered prior to the reenrollment.
Similarly, if a plan affirmatively requires individuals to reenroll
on an annual basis or allows individuals to change their enrollment, a
collection of genetic information made after a current enrollment will
not be considered made prior to a subsequent enrollment unless the
collection of information is or will be used to affect that subsequent
enrollment. Moreover, if genetic information is collected permissibly
under one plan, the information is transferred to a second plan in
connection with a merger or acquisition after this collection, and
individuals covered under the first plan are enrolling for the first
time in the second plan, the transfer of information to the second plan
will not be considered a collection prior to the effective date of
coverage under the second plan if the collection of information does
not affect the enrollment status of individuals enrolling in the second
plan.
These interim final regulations include the statutory exception (to
the prohibition against collections of genetic information prior to or
in connection with enrollment) for genetic information that is
collected incidental to the collection of other information and is not
used for underwriting purposes. Some commenters suggested that some
questions that are typically included in some HRAs and similar
documents could easily result in an individual providing genetic
information, even if the question does not mention genetic tests or
family medical history explicitly. An example given was, ``Have you had
any laboratory tests in the past 2 years?'' These commenters suggested
plans and issuers should be required to inform individuals that they
should not reveal genetic information.
The interim final regulations clarify that if it is reasonable to
anticipate that health information will be received as part of the
collection of information, the incidental collection exception does not
apply unless the collection explicitly states that genetic information
should not be provided. If, in connection with a collection of
information, it is reasonable to anticipate that health information
will be received and the collection explicitly states that genetic
information should not be provided, any genetic information provided
will be considered within the incidental exception, as long as it is
not used for underwriting purposes.
In response to the RFI, a number of comments were received
concerning the application of the prohibition on requesting genetic
information for underwriting purposes to plans and issuers that reward
individuals for completing HRAs. Of particular concern are wellness
programs including HRAs that request information about an individual's
family medical history. Another concern is the application of the
prohibition on requesting genetic information for underwriting purposes
to screening processes for disease management programs that use genetic
tests or family medical histories to identify individuals that can
benefit from the program.
GINA prohibits collecting genetic information for underwriting
purposes. As described earlier, underwriting purposes is defined
broadly to include rules for eligibility for benefits and the
computation of premium or contributions amounts, and not merely
activities relating to rating and pricing a group policy. Moreover,
GINA defines genetic information as including family medical history.
Consequently, wellness programs that provide rewards for completing
HRAs that request genetic information, including family medical
history, violate the prohibition against requesting genetic information
for underwriting purposes. This is the result even if rewards are not
based on the outcome of the assessment, which otherwise would not
violate the 2006 final HIPAA nondiscrimination rules regarding wellness
programs.
Some comments received in response to the RFI urged strongly that a
[[Page 51669]]
regulatory exception should allow wellness programs to provide rewards
for completing HRAs that request such information, notwithstanding the
statutory prohibition on collecting genetic information.\12\ Other
comments suggested equally strongly that the regulations clarify that
wellness programs may not collect such information as a condition for
rewards. These interim final regulations do not provide an exception
from underwriting for rewards provided by wellness programs, regardless
of the amount of the reward. Examples generally illustrate that any
reward given for the completion of an HRA that solicits information
about the individual's family medical history violates the requirements
of paragraph (d).
---------------------------------------------------------------------------
\12\ Earlier bills (for example, S.358, 110th Cong. (as reported
by S. Comm. on Health, Education, Labor, and Pensions) March 29,
2007; H.R. 493, 110th Cong. (as reported by H. Comm. on Energy and
Commerce) March 29, 2007) included exceptions for wellness programs
in both the Title I health coverage provisions and the Title II
employment provisions. As enacted, GINA only includes an exception
for wellness programs in the Title II employment provisions.
---------------------------------------------------------------------------
However, plans and issuers can collect genetic information through
HRAs under GINA in certain circumstances. A plan or issuer can collect
genetic information through an HRA as long as no rewards are provided
(and if the request is not made prior to or in connection with
enrollment). A plan or issuer can also provide rewards for completing
an HRA as long as the HRA does not collect genetic information. Several
examples are provided in these interim final regulations to illustrate
these points. In one example, a plan administers two distinct HRAs, one
that does not request genetic information and one that does. A reward
is provided for completing the HRA that does not solicit genetic
information; the instructions for the other HRA make clear that
completion of the HRA is wholly voluntary and will not affect the
reward given for completion of the first HRA. The example concludes
that neither HRA violates the rules against collecting information for
underwriting purposes or prior to or in connection with enrollment.
Finally, another example illustrates the application of the exception
for information obtained incidentally in the context of the acquisition
of one issuer by another. The Departments invite comment on ways in
which participation in HRAs can be encouraged while complying with the
statutory prohibition on using genetic information for underwriting
purposes.
6. Medical Appropriateness
Paragraph (e) of these interim final regulations provides examples
illustrating how medical appropriateness is determined, in connection
with both the payment exception under paragraph (c) and the prohibition
against collecting genetic information for underwriting purposes under
paragraph (d). Examples illustrate the minimum amount of genetic
information necessary to determine payment, the restriction of benefits
to medically appropriate treatment, and the application of the medical
appropriateness rules to the use of genetic information to determine
eligibility for a disease management program.
7. Special Rules Related to Very Small Group Health Plans
Generally, the provisions of HIPAA titles I and IV, as amended, do
not apply to a group health plan for a plan year if the plan is a very
small group health plan; that is, on the first day of the plan year,
the group health plan has fewer than 2 participants who are current
employees. GINA and these interim final regulations provide that this
exception for very small group health plans is not available for the
genetic information provisions in Subtitle K of the Code, Part 7 of
Subtitle B of Title I of ERISA, and Title XXVII of the PHS Act.
8. Treatment of Non-Federal Governmental Plans
Section 2721(b)(2) of the PHS Act permits the sponsor of a self-
funded non-Federal governmental plan as defined in 45 CFR 144.103 to
elect to exempt the plan from most of the requirements of Title XXVII
of the PHS Act. This is referred to herein as the ``opt-out election.''
However, section 2721(b)(2)(C)(ii) states that no opt-out election is
available with respect to the requirements for certification and
disclosure of creditable coverage. The PHS Act regulations at 45 CFR
146.180 implement the foregoing opt-out rules under section 2721.
Section 102(c) of GINA added a second limitation on the opt-out
rights of a self-funded non-Federal governmental plan sponsor. Section
2721(b)(2)(D) of the PHS Act precludes any exemption election by a
self-funded non-Federal governmental plan sponsor from GINA's
requirements. The Centers for Medicare & Medicaid Services (CMS)
amended 45 CFR 146.180(h) accordingly.
CMS made certain additional conforming changes to other provisions
of 45 CFR 146.180. In particular, CMS deleted the reference in 45 CFR
146.180(h) to CMS enforcement under 45 CFR 146.180(k) because paragraph
(k) makes clear that CMS enforces all requirements of part 146 that
apply to non-Federal governmental plans. CMS also revised the last
sentence of 45 CFR 146.180(k), which refers to the imposition of a
civil money penalty, by replacing ``under Sec. 150.305'' with ``under
subpart C of part 150'' because subpart C includes multiple sections
that govern imposition of a civil money penalty, while 45 CFR 150.305
only applies to a determination of which entity is liable for a civil
money penalty.
B. Individual Market
The regulations at 45 CFR Part 148 implement the individual market
requirements of Title XXVII of the PHS Act. Section 102(b) of GINA
added a new section 2753 (42 U.S.C. 300gg-53) to Title XXVII to
prohibit discrimination on the basis of genetic information in the
individual health insurance market. Section 2753 of the PHS Act
generally parallels the group market genetic nondiscrimination
provisions GINA added to the Code, ERISA and the PHS Act. Section 2753
and the interim final regulations prohibit issuers in the individual
market from collecting genetic information prior to or in connection
with such enrollment, and at any time for underwriting purposes.
Section 2753 and the interim final regulations also prohibit issuers
from requesting or requiring genetic tests. The exceptions and rules of
construction that apply to the foregoing requirements in the group
market (for example, the rule for incidental collections of genetic
information and the research exception to the rule against requiring
genetic tests) also apply in the individual market.
Since individual market issuers were not subject to the Federal
HIPAA nondiscrimination requirements applicable to issuers in the group
market, it was necessary for GINA to amend the PHS Act in order to have
similar protections against genetic discrimination applicable in both
markets. Thus, new section 2753 of the PHS Act prohibits issuers of
individual health insurance policies from using genetic information as
a basis for making eligibility or premium determinations, or for
imposing preexisting condition exclusions. Issuers in the individual
market may continue to establish rules for eligibility, increase
premiums, and impose preexisting condition exclusions based on the
manifestation of a disease or disorder in an individual, or in a family
[[Page 51670]]
member covered under the policy that covers the individual. However,
they cannot use a manifestation of a disease or disorder in one
individual as genetic information about family members covered under
the same policy or another policy in order to further increase
premiums.
These interim final regulations add a new Sec. 148.180 to subpart
C of part 148 to implement section 2753 of the PHS Act. To the extent
that the provisions of section 2753 parallel the GINA amendments to
section 2702 of the PHS Act which govern the group market, Sec.
148.180 restates the corresponding group market provisions (with
conforming changes and technical corrections appropriate to the
individual market) rather than incorporating the group market
provisions by reference.
As discussed above, GINA amended the Social Security Act to include
genetic nondiscrimination provisions that apply to issuers of Medigap
policies. The PHS Act regulations at 45 CFR 148.220 state that Medigap
policies are excepted benefits. Nevertheless, because Medigap policies
are subject to GINA under the Social Security Act and NAIC model
regulation, CMS made clarifying changes to Sec. 148.220 to emphasize
the foregoing.
III. Interim Final Regulations and Request for Comments
Section 9833 of the Code, section 734 of ERISA, and section 2792 of
the PHS Act authorize the Secretaries of the Treasury, Labor, and HHS
to promulgate any interim final rules that they determine are
appropriate to carry out the provisions of Chapter 100 of Subtitle K of
the Code, Part 7 of Subtitle B of Title I of ERISA, and Part A of Title
XXVII of the PHS Act, which include the provisions of GINA.
Under Section 553(b) of the Administrative Procedure Act (5 U.S.C.
551 et seq.) a general notice of proposed rulemaking is not required
when an agency, for good cause, finds that notice and public comment
thereon are impracticable, unnecessary, or contrary to the public
interest.
These rules are being adopted on an interim final basis because the
Secretaries have determined that without prompt guidance some members
of the regulated community may not know what steps to take to comply
with the requirements of GINA, which may result in an adverse impact on
participants and beneficiaries with regard to their health benefits
under group health plans and the protections provided under GINA.
Moreover, GINA's requirements will affect the regulated community in
the immediate future.
The requirements of sections 101 through 103 of GINA are effective
for all group health plans and for health insurance issuers offering
coverage in connection with such plans for plan years beginning after
May 21, 2009. Plan administrators and sponsors, issuers, and
participants and beneficiaries will need guidance on how to comply with
the new statutory provisions. As noted earlier, these interim rules
take into account comments received by the Departments in response to
the request for information on GINA published in the Federal Register
on October 10, 2008 (73 FR 60208). For the foregoing reasons, the
Departments find that the publication of a proposed regulation, for the
purpose of notice and public comment thereon, would be impracticable,
unnecessary, and contrary to the public interest.
IV. Economic Impact and Paperwork Burden
A. Summary--Department of Labor and Department of Health and Human
Services
As discussed above, Title I of GINA generally prohibits group
health plans and health insurance issuers in both the group and
individual markets from discriminating based on genetic information,
requesting or requiring an individual to undergo a genetic test, and
collecting genetic information prior to or in connection with
enrollment or for underwriting purposes. The Departments have crafted
these interim final regulations to secure the protections from
discrimination intended by Congress in as economically efficient a
manner as possible. Although the Departments are unable to quantify the
regulations' economic benefits, they have quantified their costs and
have provided a qualitative discussion of some of the benefits that may
stem from this rule.
One potential benefit associated with GINA and these interim final
regulations is that genetic testing and research may expand when
discrimination based on genetic information and the collection of such
information is prohibited, if these protections allay individuals'
fears of adverse health coverage-related consequences from undergoing
genetic testing and participating in research studies examining genetic
information. An increase in genetic testing and research, in turn,
could provide greater knowledge regarding the genetic basis of disease,
which could facilitate the early diagnosis and treatment of individuals
with a genetic predisposition toward developing certain diseases and
disorders and may allow scientists to develop new medicines,
treatments, and therapies that could enhance the health and welfare of
Americans.
B. Statement of Need for Regulatory Action
Congress directed the Departments to issue regulations implementing
the GINA provisions not later than 12 months after the date of
enactment. In response to this Congressional directive, these interim
final regulations clarify and interpret the GINA nondiscrimination
provisions under section 702 of ERISA, sections 2702 and 2753 of the
PHS Act, and section 9802 of the Code. These regulations are needed to
secure and implement GINA's nondiscrimination provisions and ensure
that the rights provided to participants, beneficiaries, and other
individuals under GINA are fully realized. The Departments' assessment
of the expected economic effects of these interim final regulations is
discussed in detail below.
C. Executive Order 12866--Department of Labor and Department of Health
and Human Services
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the
Departments must determine whether a regulatory action is
``significant'' and therefore subject to the requirements of the
Executive Order and review by the Office of Management and Budget
(OMB). Under section 3(f), the order defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or Tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raising novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in the Executive Order.
Pursuant to the terms of the Executive Order, the Departments have
determined that this action raises novel policy issues arising out of
legal mandates. Therefore, the interim final regulations are
``significant'' and subject
[[Page 51671]]
to OMB review under Section 3(f)(4) of the Executive Order.
Accordingly, the Departments have undertaken, as described below, an
assessment of the costs and benefits of the regulation. Over the 10-
year period of 2010 to 2019, the present value of the costs, using a
discount rate of 7 percent, is estimated to be $294.8 million in 2009
Dollars, as is shown in Table 1.
All other numbers included in the text are not discounted.
Table 1--Total Discounted Costs of Rule
[In millions of 2009 dollars]
----------------------------------------------------------------------------------------------------------------
Total costs--
Year Wellness plan Individual Medical record Research discounted at
review market review review disclosure 7%
----------------------------------------------------------------------------------------------------------------
(B) (C) (D) (E) B + C + D + E
----------------------------------------------------------------------------------------------------------------
2010............................ $2.0 $5.3 $38.3 $0 $45.5
2011............................ .............. .............. 35.8 .............. 35.8
2012............................ .............. .............. 33.4 .............. 33.4
2013............................ .............. .............. 31.2 .............. 31.2
2014............................ .............. .............. 29.2 .............. 29.2
2015............................ .............. .............. 27.3 .............. 27.3
2016............................ .............. .............. 25.5 .............. 25.5
2017............................ .............. .............. 23.8 .............. 23.8
2018............................ .............. .............. 22.3 .............. 22.3
2019............................ .............. .............. 20.8 .............. 20.8
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Total with 7% Discounting... .............. .............. .............. .............. 294.8
Total with 3% Discounting... .............. .............. .............. .............. 356.8
----------------------------------------------------------------------------------------------------------------
Note: The displayed numbers are rounded and therefore may not add up to the totals. They are discounted using a
7 percent discount rate unless otherwise noted.
The Departments performed a comprehensive, unified analysis to
estimate the costs and, to the extent feasible, provide a qualitative
assessment of benefits attributable to the statute and regulations for
purposes of compliance with Executive Order 12866, the Regulatory
Flexibility Act, and the Paperwork Reduction Act. The Departments'
assessment and underlying analysis is set forth below.
1. Affected Entities and Other Assumptions
The Departments estimate that 137.1 million participants and
beneficiaries \13\ are covered by nearly 2.5 million private sector
group health plans and 31.7 million individuals are covered by
individual health insurance policies.\14\ The Departments also estimate
that approximately 630 insurers will be are affected by GINA,
consisting of approximately 460 insurers offering coverage in
connection with insured group health plans and approximately 490 health
insurance issuers offering policies in the individual health insurance
market.\15\
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\13\ Departments' estimates based on the March 2007 Current
Population Survey.
\14\ Departments' estimates based on the March 2008 Current
Population Survey.
\15\ Estimates are from 2007 NAIC financial statements data and
the California Department of Managed Healthcare (http://wpso.dmhc.ca.gov/hpsearch/viewall.aspx).
---------------------------------------------------------------------------
2. Benefits
One potential benefit associated with GINA and these interim final
regulations is that genetic testing and research may increase if the
protections provided under GINA allay the public's concerns that health
plans and insurers will use genetic information to discriminate based
on the collection and disclosure of such information. Comments received
in response to the RFI indicate that genetic testing and research
currently are being underutilized. A major reason cited for the lack of
genetic testing is the public's fear of adverse employment-related or
health coverage-related consequences associated with having genetic
testing or participating in research studies that examine genetic
information. Removing barriers that impede the growth of genetic
testing and research has the potential to improve health and save lives
by providing patients and physicians with critical knowledge to
facilitate early intervention often before disease symptoms are
manifested. It also could expand the development of scientific
research, which could result in the development of new medicines,
therapies, and treatments for diseases and disorders.
Additional economic benefits may derive directly from the improved
clarity provided by the interim final regulations, which will reduce
uncertainty and help group health plan sponsors and health insurers
comply with GINA's requirements in a cost effective manner. Moreover,
the prohibitions enacted in GINA and these interim final regulations
should provide a benefit to individuals with genetic predispositions
for diseases by decreasing the number of individuals that are denied
coverage under a group health plan or priced out of the individual
health insurance market.\16\
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\16\ When scoring the GINA bill the Congressional Budget Office
estimated that the bill would increase health insurance coverage by
about 600 people a year with most being in the individual market.
Congressional Budget Office Cost Estimate, H.R. 493 Genetic
Information Nondiscrimination Act of 2007, April 12, 2007.
---------------------------------------------------------------------------
Currently, the Departments are unable to quantify these benefits,
because relatively few genetic tests and research studies are performed
in the private sector \17\ and a limited number of genetic tests are
available. As stated above, the Departments expect the number of
genetic tests and research studies to increase in the near future. The
Departments, however, lack sufficient information to project the
trajectory of this increase.
---------------------------------------------------------------------------
\17\ Pollitz, Karen, et. al. ``Genetic Discrimination in Health
Insurance: Current Legal Protections and Industry Practices.''
Inquiry 44:350-368 (Fall 2007).
---------------------------------------------------------------------------
3. Costs
a. Health Risk Assessments
As discussed above, GINA and these interim final regulations
prohibit group health plans and health insurance issuers offering
coverage in the group and individual health insurance markets from
collecting genetic information in
[[Page 51672]]
connection with or prior to enrollment and for underwriting purposes.
Comments received in response to the RFI indicate that the immediate
impact of GINA and these interim final regulations on group health
plans and health insurance issuers providing group health coverage
should be minimal. Plans and issuers commented that they do not collect
or use genetic information for underwriting purposes because pre-GINA
laws and regulations prohibit them from discriminating against
individuals based on any health status-related factors, including
genetic information.\18\
---------------------------------------------------------------------------
\18\ See e.g., Comments from BlueCross BlueShield Association,
pg. 3 (http://www.dol.gov/ebsa/pdf/cmt-12190808.pdf) and Society for
Human Resource Management, pg. 2 (http://www.dol.gov/ebsa/pdf/cmt-12190813.pdf).
---------------------------------------------------------------------------
Currently, many group health plans request family medical history
information to be provided in response to questions on HRAs that are
completed by new employees before enrollment in the plan and as part of
open enrollment for current employees. HRAs are used in connection with
wellness and disease management programs to identify individuals at
risk for certain conditions and provide an opportunity for preventive
treatment service referrals, disease management, and other behavioral
change initiatives that are focused on creating higher quality medical
outcomes. Some group health plans provide rewards and incentives to
employees who complete HRAs, such as premium reductions, lower
deductibles, and cash bonus payments.
The Departments expect that most of the cost of complying with GINA
and these interim final regulations will be concentrated among the
approximately 30,000 group health plans \19\ that are associated with
wellness and disease management programs that provide rewards and
incentives to employees that complete HRAs. These plans will have to
conduct a compliance review to ensure that their HRAs and any
associated policies and procedures comply with GINA's prohibition on
using genetic information prior to or in connection with enrollment or
for underwriting purposes and to make any necessary changes to their
HRAs and policies and procedures.
---------------------------------------------------------------------------
\19\ This estimate is based on the Kaiser Family Foundation
Survey, Employer Health Benefits 2008 Annual Survey: Wellness
Programs and Employer Opinions, section 12, which estimates that 10%
of plans have health risk assessment and 12% of those offer a
financial incentive to employees that complete HRAs (2.5 million
group health plans x 10% of plans have health risk assessments x 12%
of those plans that offer financial rewards and incentives = 30,000
plans).
---------------------------------------------------------------------------
The Departments assume that insured plans will rely on the health
insurance issuer providing coverage to ensure compliance and that self-
insured plans will rely on wellness vendors and other service providers
to ensure compliance. These interim final regulations provide several
examples illustrating the application of the regulations to HRAs, which
are intended to reduce the compliance burden. Moreover, the per plan
compliance cost is expected to be low, because vendors and insurers
will be able to spread these costs across multiple client plans.\20\
---------------------------------------------------------------------------
\20\ There are about 30,000 plans with health risk assessments
and about 460 insurers in the group market; this is an average of 65
plans per insurer.
---------------------------------------------------------------------------
The Departments assume that the average burden per plan will be
one-half hour of a legal professional's time at an hourly labor rate of
$116,\21\ and one-half hour of a clerical staff's time at an hourly
labor rate of $26 to conduct the compliance review and make the needed
changes to the HRAs. This results in a total cost of $2.1 million ($1.7
for legal services, and $0.4 million for clerical services) in the
first year. The Departments invite public comments on this estimate.
---------------------------------------------------------------------------
\21\ EBSA estimates based on the National Occupational
Employment Survey (May 2007, Bureau of Labor Statistics) and the
Employment Cost Index June 2008, Bureau of Labor Statistics).
---------------------------------------------------------------------------
To the extent that GINA and these interim final regulations
prohibit group health plans and issuers from incentivizing employees to
complete HRAs requesting genetic information, including family medical
history, and response rates for HRAs drop as a consequence, a cost may
be incurred that is associated with the forgone benefits of identifying
disease risks early and preventing their onset. The Departments do not
have adequate data to determine whether these forgone benefits would
materialize, and, if so, what their extent may be. However, the
Departments invite public comments on this issue, including evidence-
based estimates of what the extent of these forgone benefits may be, if
any, and ways in which these public health benefits may be realized
while complying with the statutory prohibition on using genetic
information for underwriting purposes.
b. GINA's Impact on the Individual Health Insurance Market
The Department of Health and Human Services expects that the
individual health insurance market will incur higher costs of complying
with these interim final regulations than group health plans. The
Departments assume that health insurance issuers in the individual
market will have to review their applications and underwriting policies
and procedures to ensure that genetic information is not collected or
used for underwriting purposes. Issuers also will need to train
underwriters to avoid using genetic information in underwriting. The
Departments estimate that the approximately 490 issuers in the
individual health insurance market will spend approximately 100 hours
in-house each conducting a compliance review, modifying their
applications and policies and procedures, and drafting training
materials and providing training sessions for underwriters to ensure
compliance with GINA and these interim final regulations at a labor
rate of $116. This results in a total cost of about $5.6 million. The
Departments invite public comments on this estimate.
One comment received in response to the RFI indicated that
underwriters in the individual health insurance market request medical
records from medical service providers for approximately 20 percent of
applicants.\22\ It is likely that most of these medical records contain
information relating to family medical history. In a survey, 16 of 23
senior medical underwriters reported that while investigating an
applicant's medical history, they had encountered genetic information
about an applicant at least once in the applicant's history.\23\ As
explained earlier, these interim final regulations would require health
insurance issuers in the individual market to explicitly state that
genetic information--including family medical history--should not be
provided when an issuer requests medical records from medical services
providers for underwriting purposes. In turn, issuers may request that
medical services providers redact any family medical history
information regarding an applicant that is contained in medical records
requested by an issuer to ensure that the provisions of GINA and these
interim final regulations are not violated. However, as explained
earlier under the discussion of the incidental collection exception, if
medical services providers do not comply with the issuers' requests to
redact such information, the collection of genetic information would
count as an ``incidental collection'' of genetic information on the
part of issuers, and these interim final regulations would
[[Page 51673]]
not be violated so long as the issuers do not use the genetic
information for underwriting purposes.
---------------------------------------------------------------------------
\22\ This comment may be accessed at the following URL: http://www.dol.gov/ebsa/regs/cmt-geneticinfoND.html.
\23\ Pollitz, Karen, et al., ``Genetic Discrimination in Health
Insurance: Current Legal Protections and Industry Practices.''
Inquiry, 44: 350-368 (Fall 2007).
---------------------------------------------------------------------------
The Departments assume that medical service providers will be
responsible for redacting genetic information from medical records
before submitting the records to insurers, and that trained medical
staff will be used for this purpose. The Departments estimate that, on
average, health insurance issuers will request 3 million medical
records per year, and that medical records staff will spend one-half
hour per request redacting genetic information from requested medical
records, at a labor rate of $26 per hour. This results in a total
annual cost of nearly $41 million. The Departments invite public
comments on this estimate.
c. Research Exception
As discussed above, GINA and these interim final regulations
provide an exception to the limitations on requesting or requiring
genetic testing, which allows a group health plan or group health
insurance issuer to request, but not require, a participant or
beneficiary to undergo a genetic test \24\ if all of the following
conditions of the research exception are satisfied:
---------------------------------------------------------------------------
\24\ Comments indicated that at least one issuer is engaging in
a long-term research study involving genetic testing. Others may be
planning similar research.
---------------------------------------------------------------------------
The request must be made pursuant to research that
complies with 45 CFR Part 46 (or equivalent Federal regulations) and
any applicable State or local law or regulations for the protection of
human subjects in research. To comply with the informed consent
requirements of 45 CFR 46.116(a)(8), participants in the research must
receive a disclosure that participation in the research is voluntary,
refusal to participate cannot involve any penalty or loss of benefits
to which the subject is otherwise entitled, and participation may be
discontinued at any time without penalty or loss of benefits to which
the subject is entitled when the participant's informed consent is
sought (the participant disclosure).\25\ These interim final
regulations provide that when participants receive the participant
disclosure required under 45 CFR 46.116(a)(8) when their informed
consent is sought, no additional disclosures are required for purposes
of the GINA research exception.
---------------------------------------------------------------------------
\25\ The regulations at 45 CFR 46.116(c) and (d) provide for the
waiver or alteration of the requirements for obtaining informed
consent in certain cases. However, given the second condition
established for this research exception under GINA, it is unlikely
that a waiver of informed consent could be granted under 45 CFR
46.116(c) or (d). According to 45 CFR 46.116(c) and (d), one of the
conditions that must be met in order for a waiver to be granted is
that the research could not practicably be carried out without the
waiver. The second condition of this research exception under GINA
states that a plan or issuer may request, but not require, that a
participant or beneficiary undergo genetic testing for research
purposes only if the plan or issuer makes the request in writing and
clearly indicates that compliance with the request is voluntary.
Since it is difficult to envision a circumstance where it would be
the case that research could not be practicably carried out without
a waiver of informed consent under 45 CFR 46.116(c) or (d), and yet
be able to satisfy the second condition of this research exception
under GINA, we expect that for research studies conducted under the
research exception under GINA, it is unlikely that informed consent
could be waived under 45 CFR 46.116(c) or (d).
---------------------------------------------------------------------------
The plan or issuer must make the request in writing and
must clearly indicate to each participant or beneficiary (or in the
case of a minor child, to the legal guardian of such beneficiary) to
whom the request is made that compliance with the request is voluntary
and noncompliance will have no effect on eligibility for benefits or
premium or contribution amounts.
None of the genetic information collected or acquired as a
result of the research may be used for underwriting purposes.
The plan or issuer must complete a copy of the ``Notice of
Research Exception under the Genetic Information Nondiscrimination
Act'' (the Notice) and provide it to the address specified in its
instructions. The Notice and instructions are available on the
Department of Labor's Web site (http://www.dol.gov/ebsa).
The Departments estimate that up to five entities (consisting of
group health plans and health insurance issuers in the group and
individual markets) will use the genetic research exception and assume
that the requirements of 45 CFR Part 46 will be satisfied. Based on the
foregoing, the Departments assume that all group health plans and group
health insurance issuers using the exemption will not have to send a
disclosure to participants in the genetic research, because they will
comply with the requirements of 45 CFR Part 46.116(a)(8). Therefore,
the only incremental cost imposed by these interim final regulations
will be for the group health plans and group health issuers to send the
Notice to the appropriate Department.\26\ Because this cost is de
minimis, it has not been included in this Regulatory Impact Analysis.
---------------------------------------------------------------------------
\26\ The instructions to the Notice will specify the appropriate
Department to which the Notice should be submitted.
---------------------------------------------------------------------------
4. Uncertainty
a. Adverse Selection
GINA's prohibition on the use and collection of genetic information
could increase the potential for adverse selection in the individual
health insurance market. Adverse selection arises when individuals
seeking coverage have information about their health risks that issuers
do not know.\27\
---------------------------------------------------------------------------
\27\ For example, individuals who obtain results from genetic
tests indicating the risk of contracting a serious medical condition
could benefit financially by ``choosing the timing of purchases, and
the type and level of benefits purchased. This biased selection
would have a direct impact on premium rates, ultimately raising the
cost of insurance to everyone.'' American Academy of Actuaries,
``Genetic Information and Medical Expense Insurance,'' June 2000.
---------------------------------------------------------------------------
Such information asymmetry can prevent the insurer from assessing
the individual's risk accurately enough to determine the appropriate
premium to charge. On average, if issuers do not accurately assess the
risks they assume, they will pay more in claims than they receive in
premiums. To eliminate this shortfall, issuers may be forced to raise
premiums for all insureds. If issuers raise premiums for all insureds,
those with a perceived low risk of needing medical care might drop
their coverage. This outcome in serious cases may lead to a continued
cycle of across-the-board premium increases.
The Departments are not able to measure the extent to which GINA
might lead to adverse selection and thereby raise premiums in the
individual health insurance market, or whether GINA protections of
genetic information will increase the total number of persons insured
under individual health insurance policies relative to the number that
might leave the market due to increased premiums. Currently, with few
tests being performed, the Departments expect the impact to be minimal;
however, as the number of tests increases, the effects of adverse
selection on the individual health insurance market also could increase
and the impact of adverse selection could grow.
b. Impact of GINA on Health Care Expenditures
Another uncertainty associated with GINA and these interim final
regulations is whether total health care expenditures will increase or
decrease. Whether expenditures will increase or decrease is dependent
on a number of factors such as the following: The cost and predictive
power of tests, how widely the tests are performed among the
population, whether detected gene abnormalities are based on a single
gene
[[Page 51674]]
or also involve environmental and other confounding factors which lower
the predictive value of the test and treatment, and whether treatments
for detected gene abnormalities are less costly than treatments for the
manifested disease.
Genetic testing typically is not covered under individual health
insurance policies; group health plans are far more likely to cover
both the tests and associated treatments.\28\ As the number of genetic
tests performed increases, the Departments expect group health care
premiums will rise to offset the increased costs to insurers, and any
increase or decrease in overall expenditures is expected to result in
increased or decreased premiums for the group market.
---------------------------------------------------------------------------
\28\ American Academy of Actuaries, Genetic Information and
Medical Expense Insurance. June 2000.
---------------------------------------------------------------------------
D. Regulatory Flexibility Act--Department of Labor and Department of
Health and Human Services
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes
certain requirements with respect to Federal rules that are subject to
the notice and comment requirements of section 553(b) of the
Administrative Procedure Act (5 U.S.C. 551 et seq.) and that are likely
to have a significant economic impact on a substantial number of small
entities. Because these rules are being issued as interim final
regulations, the RFA does not apply and the Departments are not
required to either certify that the rule would not have a significant
economic impact on a substantial number of small entities or conduct a
regulatory flexibility analysis.
Nevertheless, the Departments carefully considered the likely
impact of the rule on small entities in connection with their
assessment under Executive Order 12866. The Departments expect the
rules to reduce the compliance burden imposed on plans and insurers by
clarifying definitions and terms contained in the statute and providing
examples of acceptable methods to comply with specific provisions.
Based on the foregoing, and as further discussed below, the Departments
hereby certify that the rule will not have a significant economic
impact on a substantial number of small entities.\29\
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\29\ For purposes of this certification, the Departments
continue to consider a small entity to be an employee benefit plan
with fewer than 100 participants. The basis of this definition is
found in section 104(a)(2) of ERISA, which permits the Secretary of
Labor to prescribe simplified annual reports for pension plans which
cover fewer than 100 participants. The Departments consulted with
the Small Business Administration in making this determination as
required by 5 U.S.C. 601(3) and 13 CFR 121.903(c).
---------------------------------------------------------------------------
The Departments expect most of the cost of complying with GINA and
the rules to be concentrated among group health plans associated with
wellness and disease management programs providing rewards and
incentives to employees who complete Health Risk Assessments (HRAs).
The Departments estimate that approximately 15,000 (out of 2.4 million)
small plans (or 0.00625 of all group health plans) will need to review
their HRAs to ensure that genetic information is not used prior to or
in connection with enrollment or for underwriting purposes and to make
any necessary changes to forms and policies and procedures. This
process is estimated to require one-half hour of a legal professional's
time at an hourly labor rate of $116 and one-half hour of a clerical
staff member's time at an hourly labor rate of $26 resulting in an
average cost to the plans of $71 ($58 + $13).
Health insurers in both the group and individual health insurance
markets will have to ensure compliance with the GINA and the rules. For
this purpose, using the Small Business Administration's definition of a
small business as a business with less than $7 million in revenues,
premiums earned as a measure of revenue, and data obtained from the
National Association of Insurance Commissioners, the Departments
estimate that approximately 75 out of 630 insurers had revenues of less
that $7 million, and, of these, about 25 had revenues of less than $1
million.
The Departments estimate that each insurer on average would spend
100 hours of professional time at an hourly labor rate of $116 to
revise policies and procedures and train underwriters about GINA. This
would result in an estimated one time average cost of $11,600 per
insurer. For the approximately 25 insurers with revenues of less than
$1 million, this burden could be more than one percent of premiums.
However, the estimated costs are an average cost for plans of all
sizes, and the Departments expect small insurers to have lower
implementation costs, because they have fewer underwriters and other
staff members to train.
The Departments invite public comments on this certification.
E. Special Analyses--Department of the Treasury
Notwithstanding the determinations of the Department of Labor and
Department of Health and Human Services, for purposes of the Department
of the Treasury, it has been determined that this Treasury decision is
not a significant regulatory action for purposes of Executive Order
12866. Therefore, a regulatory assessment is not required. It has also
been determined that section 553(b) of the Administrative Procedure Act
(5 U.S.C. chapter 5) does not apply to these regulations. For the
applicability of the RFA, refer to the Special Analyses section in the
preamble to the cross-referencing notice of proposed rulemaking
published elsewhere in this issue of the Federal Register. Pursuant to
section 7805(f) of the Code, these interim final regulations will be
submitted to the Chief Counsel for Advocacy of the Small Business
Administration for comment on their impact on small businesses.
F. Paperwork Reduction Act
1. Department of Labor and Department of the Treasury
As part of their continuing efforts to reduce paperwork and
respondent burden, the Departments conduct a preclearance consultation
program to provide the general public and Federal agencies with an
opportunity to comment on proposed and continuing collections of
information in accordance with the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3506(c)(2)(A)). This helps to ensure that requested
data can be provided in the desired format, reporting burden (time and
financial resources) is minimized, collection instruments are clearly
understood, and the impact of collection requirements on respondents
can be properly assessed.
As discussed above, GINA and these interim final regulations
provide an exception to the limitations on requesting or requiring
genetic testing that allow a group health plan or group health
insurance issuer to request, but not require, a participant or
beneficiary to undergo a genetic test \30\ if all of the following
conditions of the research exception set forth in 29 CFR 2590.702-
1(c)(5) are satisfied:
---------------------------------------------------------------------------
\30\ Comments indicated that at least one issuer is engaging in
a long-term research study involving genetic testing. Others may be
planning similar research.
---------------------------------------------------------------------------
The request must be made pursuant to research that
complies with 45 CFR Part 46 (or equivalent Federal regulations) and
any applicable State or local law or regulations for the protection of
human subjects in research. To comply with the informed consent
requirements of 45 CFR 46.116(a)(8), a participant must receive a
disclosure that participation in the research is voluntary, refusal to
participate cannot involve any penalty
[[Page 51675]]
or loss of benefits to which the subject is otherwise entitled, and the
subject may discontinue participation at any time without penalty or
loss of benefits to which the subject is entitled (the participant
disclosure).\31\ These interim final regulations provide that when the
participant disclosure is received by participants when their informed
consent is sought, no additional disclosures are required for purposes
of the GINA research exception.
---------------------------------------------------------------------------
\31\ While 45 CFR 46.116(c) and (d) permit a waiver of the
disclosure otherwise required under 45 CFR 46.116(a)(8), it is
unlikely that such a waiver could be granted for research studies
conducted under the research exception under GINA. See footnote 25.
---------------------------------------------------------------------------
The plan or issuer must make the request in writing and
must clearly indicate to each participant or beneficiary (or in the
case of a minor child, to the legal guardian of such beneficiary) to
whom the request is made that compliance with the request is voluntary
and noncompliance will have no effect on eligibility for benefits or
premium or contribution amounts.
None of the genetic information collected or acquired as a
result of the research may be used for underwriting purposes.
The plan or issuer must complete a copy of the ``Notice of
Research Exception under the Genetic Information Nondiscrimination
Act'' (the Notice) and provide it to the address specified in its
instructions. The Notice and instructions are available on the
Department of Labor's Web site (http://www.dol.gov/ebsa).
Two information collection requests (ICRs) are associated with the
genetic research exception--the participant disclosure and the Notice.
The Departments estimate that up to three entities will take advantage
of the research exception, and that all of the entities will comply
with the requirements of 45 CFR Part 46, including providing the
participant disclosure.
The Departments are not soliciting comments concerning an ICR
pertaining to the participant disclosure, because these interim final
regulations provide that group health plans and group health insurance
issuers meeting the requirements of 45 CFR Part 46 are not required to
provide additional disclosures, and the Departments have assumed that
all entities using the research exemption will meet these requirements.
The costs and burdens associated with complying with the participant
disclosure requirement already are accounted for in the information
collection request for the informed consent requirements contained in
45 CFR Part 46 approved under the Department of Health and Human
Services' OMB Control Number (0990-0260).
Currently, the Departments are soliciting comments concerning the
Notice. The Departments have submitted a copy of these interim final
regulations to OMB in accordance with 44 U.S.C. 3507(d) for review of
its information collections. The Departments and OMB are particularly
interested in comments that:
Evaluate whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
Evaluate the accuracy of the agency's estimate of the
burden of the collection of information, including the validity of the
methodology and assumptions used;
Enhance the quality, utility, and clarity of the
information to be collected; and
Minimize the burden of the collection of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, for example, by
permitting electronic submission of responses.
Comments should be sent to the Office of Information and Regulatory
Affairs, Attention: Desk Officer for the Employee Benefits Security
Administration either by fax to (202) 395-7285 or by e-mail to [email protected]. Although comments may be submitted through
December 7, 2009, OMB requests that comments be received within 30 days
of publication of these interim final regulations to ensure their
consideration. A copy of the ICR may be obtained by contacting the PRA
addressee: G. Christopher Cosby, Office of Policy and Research, U.S.
Department of Labor, Employee Benefits Security Administration, 200
Constitution Avenue, NW., Room N-5718, Washington, DC 20210. Telephone:
(202) 693-8410; Fax: (202) 219-4745. These are not toll-free numbers.
E-mail: [email protected]. ICRs submitted to OMB also are available at
reginfo.gov (http://www.reginfo.gov/public/do/PRAMain).
The Departments estimate that completing and mailing the Notice
will require 15 minutes of clerical time at an hourly rate of $26 per
hour. Therefore, the total hour burden associated with completing the
Notice is estimated to be 0.75 hours of clerical time. The cost burden
consists of material and mailing cost to mail the two-page Notice and
is estimated to total $20. Although the Departments share the burden
for this ICR, the Departments have agreed to allocate the hour and cost
burden associated with the rule entirely to the Department of Labor,
because it is so minimal. The Departments note that persons are not
required to respond to, and generally are not subject to any penalty
for failing to comply with, an ICR unless the ICR has a valid OMB
control number.\32\
---------------------------------------------------------------------------
\32\ 5 CFR 1320.1 through 1320.18.
---------------------------------------------------------------------------
These paperwork burden estimates are summarized as follows:
Type of Review: New collection.
Agencies: Employee Benefits Security Administration, Department of
Labor; Internal Revenue Service, Department of the Treasury.
Title: Notice of Research Exception under the Genetic Information
Nondiscrimination Act.
OMB Number: 1210-NEW.
Affected Public: Business or other for-profit; not-for-profit
institutions.
Respondents: 3.
Responses: 3.
Frequency of Response: Occasionally.
Estimated Total Annual Burden Hours: 0.75 hours.
Estimated Total Annual Burden Cost: $20.
2. Department of Health and Human Services
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
[[Page 51676]]
a. ICRs Regarding Additional Requirements Prohibiting Discrimination
Based on Genetic Information (Sec. 146.122)
As stated in the interim final regulations at 45 CFR 146.122(c),
there are limitations on requesting or requiring genetic testing. The
interim final regulations at 45 CFR 146.122(c)(1) state that a group
health plan, and a health insurance issuer offering health insurance
coverage in connection with a group health plan, must not request or
require an individual or a family member of the individual to undergo a
genetic test. Section 146.122(c)(5) explains the research exception
with respect to the limitations on requesting or requiring genetic
testing as defined in 45 CFR 146.122(c)(1). Specifically, 45 CFR
146.122(c)(5) states that a plan or issuer may request, but not
require, that a participant or beneficiary undergo a genetic test if
all of the following conditions are met:
The request must be made pursuant to research that
complies with 45 CFR Part 46 (or equivalent Federal regulations) and
any applicable State or local law or regulations for the protection of
human subjects in research. To comply with the informed consent
requirements of 45 CFR 46.116(a)(8), a participant must receive a
disclosure that participation in the research is voluntary, refusal to
participate cannot involve any penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is entitled (the participant disclosure).\33\ These interim
final regulations provide that when the participant disclosure is
received by participants when their informed consent is sought, no
additional disclosures are required for purposes of the GINA research
exception.
---------------------------------------------------------------------------
\33\ While 45 CFR 46.116(c) and (d) permit a waiver of the
disclosure otherwise required under 45 CFR 46.116(a)(8), it is
unlikely that such a waiver could be granted for research studies
conducted under the research exception under GINA. See footnote 25.
---------------------------------------------------------------------------
The plan or issuer must make the request in writing and
must clearly indicate to each participant or beneficiary (or in the
case of a minor child, to the legal guardian of such beneficiary) to
whom the request is made that compliance with the request is voluntary
and noncompliance will have no effect on eligibility for benefits or
premium or contribution amounts.
None of the genetic information collected or acquired as a
result of the research may be used for underwriting purposes.
The plan or issuer must complete a copy of the ``Notice of
Research Exception under the Genetic Information Nondiscrimination
Act'' (the Notice) and provide it to the address specified in its
instructions. The Notice and instructions are available on the
Department of Labor's Web site (http://www.dol.gov/ebsa).
There are two information collection requirements associated with
obtaining a GINA research exception. The first is the informed consent
requirement as described above. To comply with the informed consent
requirements of 45 CFR 46.116(a)(8), a participant must receive a
disclosure that participation in the research is voluntary, refusal to
participate cannot involve any penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is entitled (the participant disclosure).\34\ These interim
final regulations provide that when the participant disclosure is
received by participants when their informed consent is sought, no
additional disclosures are required for purposes of the GINA research
exception.
---------------------------------------------------------------------------
\34\ While 45 CFR 46.116(c) and (d) permit a waiver of the
disclosure otherwise required under 45 CFR 46.116(a)(8), it is
unlikely that such a waiver could be granted for research studies
conducted under the research exception under GINA. See footnote 25.
---------------------------------------------------------------------------
The burden associated with this requirement is the time and effort
necessary to develop, draft, and disseminate the information consent
notice to patients. While this requirement is subject to the PRA, the
associated burden is already approved under OMB control number 0990-
0260. We are not soliciting comments on this requirement at this time.
The second information collection requirement associated with
obtaining a GINA research exception is the Notice of Research Exception
under the Genetic Information Nondiscrimination Act (the Notice). The
burden associated with this requirement is the time and effort
necessary for a plan or issuer to complete a copy of the Notice and
submit it to CMS. CMS also estimates that completing and mailing the
Notice will require 15 minutes of clerical time at an hourly rate of
$26 per hour. Therefore, the total hour burden associated with
completing the Notice is estimated to be 0.5 hours of clerical time.
The cost burden consists of material and mailing cost to mail the two-
page Notice and is estimated to total $13.
b. ICRs Regarding Prohibition of Discrimination Based on Genetic
Information (Sec. 148.180)
The information collection requirements affecting the individual
health insurance market as stated in 45 CFR 148.180 mirror the
information collection requirements affecting the group health
insurance market as stated in 45 CFR 146.122. The burden is discussed
in detail in section IV.F.2.A. of this preamble. As stated in section
IV.F.2.A., we expect no more than a combined total of 2 entities
between the group health insurance market and the individual health
insurance market to be subject to the information collection
requirements contained in this interim final rule.
Estimated Annual Reporting and Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per
OMB control No. Regulation section(s) Respondents Responses response Total annual
(hours) burden (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-New........................................ 45 CFR 146.122.................... 2 2 .25 .50
45 CFR 148.180.................... ............... ............... ............... ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have submitted a copy of this interim final rule to OMB for its
review and approval of the aforementioned information collection
requirements. These requirements are not effective until approved by
OMB. Although comments may be submitted through December 7, 2009, OMB
requests that comments be received within 30 days of publication of
these interim final regulations to ensure their consideration.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
[[Page 51677]]
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget,
Attention: CMS Desk Officer, CMS-4137-IFC;
Fax: (202) 395-7285; or
E-mail: [email protected].
Please reference ``ICRs Regarding Prohibition of Discrimination
Based on Genetic Information (Sec. 148.180)'' when submitting your
comments.
G. Congressional Review Act
These interim final regulations are subject to the Congressional
Review Act provisions of the Small Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et seq.) and have been transmitted
to Congress and the Comptroller General for review.
H. Unfunded Mandates Reform Act
For purposes of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4), as well as Executive Order 12875, these interim final
regulations do not include any Federal mandate that may result in
expenditures by State, local, or Tribal governments, nor do they
include mandates which may impose an annual burden of $100 million or
more (as adjusted for inflation) on the private sector.
I. Federalism Statement--Department of Labor and Department of Health
and Human Services
Executive Order 13132 outlines fundamental principles of
federalism, and requires the adherence to specific criteria by Federal
agencies in the process of their formulation and implementation of
policies that have ``substantial direct effects'' on the States, the
relationship between the national government and States, or on the
distribution of power and responsibilities among the various levels of
government. Federal agencies promulgating regulations that have these
federalism implications must consult with State and local officials,
and describe the extent of their consultation and the nature of the
concerns of State and local officials in the preamble to the
regulation.
In the Departments' view, these interim final regulations have
federalism implications, because they have direct effects on the
States, the relationship between the national government and States, or
on the distribution of power and responsibilities among various levels
of government. However, in the Departments' view, the federalism
implications of these regulations are substantially mitigated because,
with respect to health insurance issuers, the Departments expect that
the majority of States will enact laws or take other appropriate action
resulting in their meeting or exceeding the Federal GINA standards
prohibiting discrimination based on genetic information.
In general, through section 514, ERISA supersedes State laws to the
extent that they relate to any covered employee benefit plan, and
preserves State laws that regulate insurance, banking, or securities.
While ERISA prohibits States from regulating a plan as an insurance or
investment company or bank, HIPAA added a new preemption provision to
ERISA (as well as to the PHS Act) narrowly preempting State
requirements for group health insurance coverage. This amendment
applies to the GINA nondiscrimination provisions. With respect to these
provisions, States may continue to apply State law requirements except
to the extent that such requirements prevent the application of the
portability, access, and renewability requirements of HIPAA, which
include GINA's nondiscrimination requirements that are the subject of
this rulemaking. State insurance laws that are more stringent than the
Federal requirements are unlikely to ``prevent the application of''
GINA, and be preempted. Accordingly, States have significant latitude
to impose requirements on health insurance issuers that are more
restrictive than the Federal law.
GINA provides the Secretary of Labor with the express authority to
impose a penalty against any health insurance issuer offering health
insurance to a group health plan covered by ERISA for any failure by
the issuer to meet the GINA requirements. The States may enforce the
provisions of GINA as they pertain to issuers, but the Secretary of HHS
is required to enforce any provisions that a State fails to
substantially enforce. This relates to HHS' responsibility to enforce
the HIPAA nondiscrimination provisions. In exercising its
responsibility, HHS works cooperatively with the State for the purpose
of addressing the State's concerns and avoiding conflicts with the
exercise of State authority. HHS has developed procedures to implement
its enforcement responsibilities, and to afford the States the maximum
opportunity to enforce HIPAA's requirements in the first instance. HHS'
procedures address the handling of reports that States may not be
enforcing HIPAA's requirements, and the mechanism for allocating
enforcement responsibility between the States and HHS. In compliance
with the requirement of Executive Order 13132 that agencies examine
closely any policies that may have federalism implications or limit the
policy making discretion of the States, the Department of Labor and HHS
have engaged in numerous efforts to consult with and work cooperatively
with affected State and local officials. It is expected that the
Departments will act in a similar fashion in enforcing the GINA
requirements.
In addition, the Departments specifically consulted with the
National Association of Insurance Commissioners (NAIC) in developing
these interim final regulations. Through the NAIC, the Departments
sought and received the input of State insurance departments regarding
certain insurance rating practices. The Departments have also
cooperated with the States in several ongoing outreach initiatives,
through which information on GINA is shared among Federal regulators,
State regulators, and the regulated community.
Throughout the process of developing these interim final
regulations, to the extent feasible within the specific preemption
provisions of HIPAA as it applies to GINA, the Departments have
attempted to balance the States' interests in regulating health
insurance issuers, and Congress's intent to provide uniform minimum
protections to consumers in every State. By doing so, it is the
Departments' view that they have complied with the requirements of
Executive Order 13132.
Pursuant to the requirements set forth in section 8(a) of Executive
Order 13132, and by the signatures affixed to these regulations, the
Departments certify that the Employee Benefits Security Administration
and the Centers for Medicare & Medicaid Services have complied with the
requirements of Executive Order 13132 for the attached interim final
regulations in a meaningful and timely manner.
V. Statutory Authority
The Department of the Treasury temporary and final regulations are
adopted pursuant to the authority contained in sections 7805 and 9833
of the Code.
The Department of Labor interim final regulations are adopted
pursuant to the authority contained in 29 U.S.C. 1027, 1059, 1135,
1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a,
1191b, and 1191c; sec.101(g), Public Law 104-191, 110 Stat. 1936; sec.
401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note);
[[Page 51678]]
sec. 101(f), Public Law 110-233, 122 Stat. 881; Secretary of Labor's
Order 1-2003, 68 FR 5374 (Feb. 3, 2003).
The Department of Health and Human Services interim final
regulations are adopted pursuant to the authority contained in sections
2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg
through 300gg-63, 300gg-91, and 300gg-92), as added by Public Law 104-
191, and amended by Public Law 104-204, Public Law 105-277, and Public
Law 110-233.
List of Subjects
26 CFR Part 54
Excise taxes, Health care, Health insurance, Pensions, Reporting
and recordkeeping requirements.
29 CFR Part 2590
Continuation coverage, Disclosure, Employee benefit plans, Group
health plans, Health care, Health insurance, Medical child support,
Reporting and recordkeeping requirements.
45 CFR Parts 144, 146, and 148
Health care, Health insurance, Reporting and recordkeeping
requirements, and State regulation of health insurance.
Amendments to the Regulations
Internal Revenue Service
26 CFR Chapter 1
0
Accordingly, 26 CFR Part 54 is amended as follows:
PART 54--PENSION EXCISE TAXES
0
Paragraph 1. The authority citation for part 54 is amended by adding an
entry for Sec. 54.9802-3T in numerical order to read in part as
follows:
Authority: 26 U.S.C. 7805. * * *
Section 54.9802-3T also issued under 26 U.S.C. 9833. * * *
0
Par. 2. Section 54.9801-1 is amended by revising paragraph (a) and
adding paragraph (b)(6) to read as follows:
Sec. 54.9801-1 Basis and scope.
(a) Statutory basis. This section and sections 54.9801-2 through
54.9801-6, 54.9802-1, 54.9802-2, 54.9802-3T, 54.9811-1, 54.9812-1T,
54.9831-1, and 54.9833-1 (portability sections) implement Chapter 100
of Subtitle K of the Internal Revenue Code of 1986.
(b) * * *
(6) Additional requirements prohibiting discrimination based on
genetic information.
* * * * *
0
Par 3. Section 54.9801-2 is amended by revising the introductory text
and revising the definition of Genetic information to read as follows:
Sec. 54.9801-2 Definitions.
Unless otherwise provided, the definitions in this section govern
in applying the provisions of Sec. 54.9801-1, this section, Sec. Sec.
54.9801-3 through 54.9801-6, 54.9802-1, 54.9802-2, 54.9802-3T, 54.9811-
1, 54.9812-1T, 54.9831-1, and 54.9833-1.
* * * * *
Genetic information has the meaning given the term in Sec.
54.9802-3T(a)(3).
* * * * *
0
Par 4. Section 54.9802-1 is amended by revising paragraphs (a)(1)(vi),
(c)(2)(i), the introductory text of paragraph (c)(2)(iii), and
paragraph (c)(2)(iii) Example 1 to read as follows:
Sec. 54.9802-1 Prohibiting discrimination against participants and
beneficiaries based on a health factor.
(a) * * * (1) * * *
(vi) Genetic information, as defined in Sec. 54.9802-3T.
* * * * *
(c) * * *
(2) Rules relating to premium rates--(i) Group rating based on
health factors not restricted under this section. Nothing in this
section restricts the aggregate amount that an employer may be charged
for coverage under a group health plan. But see Sec. 54.9802-3T(b),
which prohibits adjustments in group premium or contribution rates
based on genetic information.
* * * * *
(iii) Examples. The rules of this paragraph (c)(2) are illustrated
by the following examples:
Example 1. (i) Facts. An employer sponsors a group health plan
and purchases coverage from a health insurance issuer. In order to
determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan.
The issuer finds that Individual F had significantly higher claims
experience than similarly situated individuals in the plan. The
issuer quotes the plan a higher per-participant rate because of F's
claims experience.
(ii) Conclusion. See Example 1 in 29 CFR 2590.702(c)(2) and 45
CFR 146.121(c)(2) for a conclusion that the issuer does not violate
the provisions of 29 CFR 2590.702(c)(2) and 45 CFR 146.121(c)(2)
similar to the provisions of this paragraph (c)(2) because the
issuer blends the rate so that the employer is not quoted a higher
rate for F than for a similarly situated individual based on F's
claims experience. (However, those examples conclude that if the
issuer used genetic information in computing the group rate, it
would violate 29 CFR 2590.702-1(b) or 45 CFR 146.122(b).)
* * * * *
0
Par. 5. Section 54.9831-1 is amended by revising paragraph (b) to read
as follows:
Sec. 54.9831-1 Special rules relating to group health plans.
* * * * *
(b) General exception for certain small group health plans. (1)
Subject to paragraph (b)(2) of this section, the requirements of
Sec. Sec. 54.9801-1 through 54.9801-6, 54.9802-1, 54.9802-2, 54.9811-
1, 54.9812-1T, and 54.9833-1 do not apply to any group health plan for
any plan year if, on the first day of the plan year, the plan has fewer
than two participants who are current employees.
(2) The exception of paragraph (b)(1) of this section does not
apply with respect to the following requirements:
(i) Section 54.9801-3(b)(6).
(ii) Section 54.9802-1(b), as such paragraph applies with respect
to genetic information as a health factor.
(iii) Section 54.9802-1(c), as such paragraph applies with respect
to genetic information as a health factor.
(iv) Section 54.9802-1(e), as such paragraph applies with respect
to genetic information as a health factor.
(v) Section 54.9802-3T(b).
(vi) Section 54.9802-3T(c).
(vii) Section 54.9802-3T(d).
(viii) Section 54.9802-3T(e).
* * * * *
0
Par. 6. Section 54.9802-3T is added to read as follows:
Sec. 54.9802-3T Additional requirements prohibiting discrimination
based on genetic information (temporary).
(a) Definitions. Unless otherwise provided, the definitions in this
paragraph (a) govern in applying the provisions of this section.
(1) Collect means, with respect to information, to request,
require, or purchase such information.
(2) Family member means, with respect to an individual --
(i) A dependent (as defined for purposes of Sec. 54.9801-2) of the
individual; or
(ii) Any other person who is a first-degree, second-degree, third-
degree, or fourth-degree relative of the individual or of a dependent
of the individual. Relatives by affinity (such as by marriage or
adoption) are treated the same as relatives by consanguinity (that is,
relatives who share a common biological ancestor). In determining the
degree of the relationship, relatives by less than full consanguinity
(such as half-siblings, who share only one parent) are treated the same
as relatives by full consanguinity (such as siblings who share both
parents).
[[Page 51679]]
(A) First-degree relatives include parents, spouses, siblings, and
children.
(B) Second-degree relatives include grandparents, grandchildren,
aunts, uncles, nephews, and nieces.
(C) Third-degree relatives include great-grandparents, great-
grandchildren, great aunts, great uncles, and first cousins.
(D) Fourth-degree relatives include great-great grandparents,
great-great grandchildren, and children of first cousins.
(3) Genetic information means--
(i) Subject to paragraphs (a)(3)(ii) and (a)(3)(iii) of this
section, with respect to an individual, information about--
(A) The individual's genetic tests (as defined in paragraph (a)(5)
of this section);
(B) The genetic tests of family members of the individual;
(C) The manifestation (as defined in paragraph (a)(6) of this
section) of a disease or disorder in family members of the individual;
or
(D) Any request for, or receipt of, genetic services (as defined in
paragraph (a)(4) of this section), or participation in clinical
research which includes genetic services, by the individual or any
family member of the individual.
(ii) The term genetic information does not include information
about the sex or age of any individual.
(iii) The term genetic information includes--
(A) With respect to a pregnant woman (or a family member of the
pregnant woman), genetic information of any fetus carried by the
pregnant woman; and
(B) With respect to an individual (or a family member of the
individual) who is utilizing an assisted reproductive technology,
genetic information of any embryo legally held by the individual or
family member.
(4) Genetic services means--
(i) A genetic test, as defined in paragraph (a)(5) of this section;
(ii) Genetic counseling (including obtaining, interpreting, or
assessing genetic information); or
(iii) Genetic education.
(5)(i) Genetic test means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, if the analysis detects
genotypes, mutations, or chromosomal changes. However, a genetic test
does not include an analysis of proteins or metabolites that is
directly related to a manifested disease, disorder, or pathological
condition. Accordingly, a test to determine whether an individual has a
BRCA1 or BRCA2 variant is a genetic test. Similarly, a test to
determine whether an individual has a genetic variant associated with
hereditary nonpolyposis colorectal cancer is a genetic test. However,
an HIV test, complete blood count, cholesterol test, liver function
test, or test for the presence of alcohol or drugs is not a genetic
test.
(ii) The rules of this paragraph (a)(5) are illustrated by the
following example:
Example. (i) Facts. Individual A is a newborn covered under a
group health plan. A undergoes a phenylketonuria (PKU) screening,
which measures the concentration of a metabolite, phenylalanine, in
A's blood. In PKU, a mutation occurs in the phenylalanine
hydroxylase (PAH) gene which contains instructions for making the
enzyme needed to break down the amino acid phenylalanine.
Individuals with the mutation, who have a deficiency in the enzyme
to break down phenylalanine, have high concentrations of
phenylalanine.
(ii) Conclusion. In this Example, the PKU screening is a genetic
test with respect to A because the screening is an analysis of
metabolites that detects a genetic mutation.
(6)(i) Manifestation or manifested means, with respect to a
disease, disorder, or pathological condition, that an individual has
been or could reasonably be diagnosed with the disease, disorder, or
pathological condition by a health care professional with appropriate
training and expertise in the field of medicine involved. For purposes
of this section, a disease, disorder, or pathological condition is not
manifested if a diagnosis is based principally on genetic information.
(ii) The rules of this paragraph (a)(6) are illustrated by the
following examples:
Example 1. (i) Facts. Individual A has a family medical history
of diabetes. A begins to experience excessive sweating, thirst, and
fatigue. A's physician examines A and orders blood glucose testing
(which is not a genetic test). Based on the physician's examination,
A's symptoms, and test results that show elevated levels of blood
glucose, A's physician diagnoses A as having adult onset diabetes
mellitus (Type 2 diabetes).
(ii) Conclusion. In this Example 1, A has been diagnosed by a
health care professional with appropriate training and expertise in
the field of medicine involved. The diagnosis is not based
principally on genetic information. Thus, Type 2 diabetes is
manifested with respect to A.
Example 2. (i) Facts. Individual B has several family members
with colon cancer. One of them underwent genetic testing which
detected a mutation in the MSH2 gene associated with hereditary
nonpolyposis colorectal cancer (HNPCC). B's physician, a health care
professional with appropriate training and expertise in the field of
medicine involved, recommends that B undergo a targeted genetic test
to look for the specific mutation found in B's relative to determine
if B has an elevated risk for cancer. The genetic test with respect
to B showed that B also carries the mutation and is at increased
risk to develop colorectal and other cancers associated with HNPCC.
B has a colonoscopy which indicates no signs of disease, and B has
no symptoms.
(ii) Conclusion. In this Example 2, because B has no signs or
symptoms of colorectal cancer, B has not been and could not
reasonably be diagnosed with HNPCC. Thus, HNPCC is not manifested
with respect to B.
Example 3. (i) Facts. Same facts as Example 2, except that B's
colonoscopy and subsequent tests indicate the presence of HNPCC.
Based on the colonoscopy and subsequent test results, B's physician
makes a diagnosis of HNPCC.
(ii) Conclusion. In this Example 3, HNPCC is manifested with
respect to B because a health care professional with appropriate
training and expertise in the field of medicine involved has made a
diagnosis that is not based principally on genetic information.
Example 4. (i) Facts. Individual C has a family member that has
been diagnosed with Huntington's Disease. A genetic test indicates
that C has the Huntington's Disease gene variant. At age 42, C
begins suffering from occasional moodiness and disorientation,
symptoms which are associated with Huntington's Disease. C is
examined by a neurologist (a physician with appropriate training and
expertise for diagnosing Huntington's Disease). The examination
includes a clinical neurological exam. The results of the
examination do not support a diagnosis of Huntington's Disease.
(ii) Conclusion. In this Example 4, C is not and could not
reasonably be diagnosed with Huntington's Disease by a health care
professional with appropriate training and expertise. Therefore,
Huntington's Disease is not manifested with respect to C.
Example 5. (i) Facts. Same facts as Example 4, except that C
exhibits additional neurological and behavioral symptoms, and the
results of the examination support a diagnosis of Huntington's
Disease with respect to C.
(ii) Conclusion. In this Example 5, C could reasonably be
diagnosed with Huntington's Disease by a health care professional
with appropriate training and expertise. Therefore, Huntington's
Disease is manifested with respect to C.
(7) Underwriting purposes has the meaning given in paragraph (d)(1)
of this section.
(b) No group-based discrimination based on genetic information--(1)
In general. For purposes of this section, a group health plan must not
adjust premium or contribution amounts for any employer, or any group
of similarly situated individuals under the plan, on the basis of
genetic information. For this purpose, ``similarly situated
individuals'' are those described in Sec. 54.9802-1(d).
(2) Rule of construction. Nothing in paragraph (b)(1) of this
section (or in paragraph (d)(1) or (d)(2) of this section) limits the
ability of a group health plan to increase the premium for an
[[Page 51680]]
employer or for a group of similarly situated individuals under the
plan based on the manifestation of a disease or disorder of an
individual who is enrolled in the plan. In such a case, however, the
manifestation of a disease or disorder in one individual cannot also be
used as genetic information about other group members to further
increase the premium for an employer or a group of similarly situated
individuals under the plan.
(3) Examples. The rules of this paragraph (b) are illustrated by
the following examples:
Example 1. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that three individuals covered
under the plan had unusually high claims experience. In addition,
the issuer finds that the genetic information of two other
individuals indicates the individuals have a higher probability of
developing certain illnesses although the illnesses are not
manifested at this time. The issuer quotes the plan a higher per-
participant rate because of both the genetic information and the
higher claims experience.
(ii) Conclusion. See Example 1 in 29 CFR 2590.702-1(b)(3) or 45
CFR 146.122(b)(3) for a conclusion that the issuer violates the
provisions of 29 CFR 2590.702-1(b) or 45 CFR 146.122(b) similar to
the requirements of this paragraph (b) because the issuer adjusts
the premium based on genetic information. However, if the adjustment
related solely to claims experience, the adjustment would not
violate the requirements of 29 CFR 2590.702-1 or 45 CFR 146.122
similar to the requirements of this section (nor would it violate
the requirements of paragraph (c) of 29 CFR 2590.702 or 45 CFR
146.121 similar to the requirements of paragraph (c) of Sec.
54.9802-1, which prohibits discrimination in individual premiums or
contributions based on a health factor but permits increases in the
group rate based on a health factor).
Example 2. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that Employee A has made
claims for treatment of polycystic kidney disease. A also has two
dependent children covered under the plan. The issuer quotes the
plan a higher per-participant rate because of both A's claims
experience and the family medical history of A's children (that is,
the fact that A has the disease).
(ii) Conclusion. See Example 2 in 29 CFR 2590.702-1(b)(3) or 45
CFR 146.122(b)(3) for a conclusion that the issuer violates the
provisions of 29 CFR 2590.702-1(b) or 45 CFR 146.122(b) similar to
the requirements of this paragraph (b) because, by taking the
likelihood that A's children may develop polycystic kidney disease
into account in computing the rate for the plan, the issuer adjusts
the premium based on genetic information relating to a condition
that has not been manifested in A's children. However, the issuer
does not violate the requirements of 29 CFR 2590.702-1(b) or 45 CFR
146.122(b) similar to the requirements of this paragraph (b) by
increasing the premium based on A's claims experience.
(c) Limitation on requesting or requiring genetic testing--(1)
General rule. Except as otherwise provided in this paragraph (c), a
group health plan must not request or require an individual or a family
member of the individual to undergo a genetic test.
(2) Health care professional may recommend a genetic test. Nothing
in paragraph (c)(1) of this section limits the authority of a health
care professional who is providing health care services to an
individual to request that the individual undergo a genetic test.
(3) Examples. The rules of paragraphs (c)(1) and (c)(2) of this
section are illustrated by the following examples:
Example 1. (i) Facts. Individual A goes to a physician for a
routine physical examination. The physician reviews A's family
medical history and A informs the physician that A's mother has been
diagnosed with Huntington's Disease. The physician advises A that
Huntington's Disease is hereditary and recommends that A undergo a
genetic test.
(ii) Conclusion. In this Example 1, the physician is a health
care professional who is providing health care services to A.
Therefore, the physician's recommendation that A undergo the genetic
test does not violate this paragraph (c).
Example 2. (i) Facts. Individual B is covered by a health
maintenance organization (HMO). B is a child being treated for
leukemia. B's physician, who is employed by the HMO, is considering
a treatment plan that includes six-mercaptopurine, a drug for
treating leukemia in most children. However, the drug could be fatal
if taken by a small percentage of children with a particular gene
variant. B's physician recommends that B undergo a genetic test to
detect this variant before proceeding with this course of treatment.
(ii) Conclusion. In this Example 2, even though the physician is
employed by the HMO, the physician is nonetheless a health care
professional who is providing health care services to B. Therefore,
the physician's recommendation that B undergo the genetic test does
not violate this paragraph (c).
(4) Determination regarding payment--(i) In general. As provided in
this paragraph (c)(4), nothing in paragraph (c)(1) of this section
precludes a plan from obtaining and using the results of a genetic test
in making a determination regarding payment. For this purpose,
``payment'' has the meaning given such term in 45 CFR 164.501 of the
privacy regulations issued under the Health Insurance Portability and
Accountability Act. Thus, if a plan conditions payment for an item or
service based on its medical appropriateness and the medical
appropriateness of the item or service depends on the genetic makeup of
a patient, then the plan is permitted to condition payment for the item
or service on the outcome of a genetic test. The plan may also refuse
payment if the patient does not undergo the genetic test.
(ii) Limitation. A plan is permitted to request only the minimum
amount of information necessary to make a determination regarding
payment. The minimum amount of information necessary is determined in
accordance with the minimum necessary standard in 45 CFR 164.502(b) of
the privacy regulations issued under the Health Insurance Portability
and Accountability Act.
(iii) Examples. See paragraph (e) of this section for examples
illustrating the rules of this paragraph (c)(4), as well as other
provisions of this section.
(5) Research exception. Notwithstanding paragraph (c)(1) of this
section, a plan may request, but not require, that a participant or
beneficiary undergo a genetic test if all of the conditions of this
paragraph (c)(5) are met:
(i) Research in accordance with Federal regulations and applicable
State or local law or regulations. The plan makes the request pursuant
to research, as defined in 45 CFR 46.102(d), that complies with 45 CFR
Part 46 or equivalent Federal regulations, and any applicable State or
local law or regulations for the protection of human subjects in
research.
(ii) Written request for participation in research. The plan makes
the request in writing, and the request clearly indicates to each
participant or beneficiary (or, in the case of a minor child, to the
legal guardian of the beneficiary) that--
(A) Compliance with the request is voluntary; and
(B) Noncompliance will have no effect on eligibility for benefits
(as described in Sec. 54.9802-1(b)(1)) or premium or contribution
amounts.
(iii) Prohibition on underwriting. No genetic information collected
or acquired under this paragraph (c)(5) can be used for underwriting
purposes (as described in paragraph (d)(1) of this section).
[[Page 51681]]
(iv) Notice to Federal agencies. The plan completes a copy of the
``Notice of Research Exception under the Genetic Information
Nondiscrimination Act'' authorized by the Secretary and provides the
notice to the address specified in the instructions thereto.
(d) Prohibitions on collection of genetic information--(1) For
underwriting purposes--(i) General rule. A group health plan must not
collect (as defined in paragraph (a)(1) of this section) genetic
information for underwriting purposes. See paragraph (e) of this
section for examples illustrating the rules of this paragraph (d)(1),
as well as other provisions of this section.
(ii) Underwriting purposes defined. Subject to paragraph
(d)(1)(iii) of this section, underwriting purposes means, with respect
to any group health plan, or health insurance coverage offered in
connection with a group health plan--
(A) Rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the plan or
coverage as described in Sec. 54.9802-1(b)(1)(ii) (including changes
in deductibles or other cost-sharing mechanisms in return for
activities such as completing a health risk assessment or participating
in a wellness program);
(B) The computation of premium or contribution amounts under the
plan or coverage (including discounts, rebates, payments in kind, or
other premium differential mechanisms in return for activities such as
completing a health risk assessment or participating in a wellness
program);
(C) The application of any preexisting condition exclusion under
the plan or coverage; and
(D) Other activities related to the creation, renewal, or
replacement of a contract of health insurance or health benefits.
(iii) Medical appropriateness. If an individual seeks a benefit
under a group health plan, the plan may limit or exclude the benefit
based on whether the benefit is medically appropriate, and the
determination of whether the benefit is medically appropriate is not
within the meaning of underwriting purposes. Accordingly, if an
individual seeks a benefit under the plan and the plan conditions the
benefit based on its medical appropriateness and the medical
appropriateness of the benefit depends on genetic information of the
individual, then the plan is permitted to condition the benefit on the
genetic information. A plan is permitted to request only the minimum
amount of genetic information necessary to determine medical
appropriateness. The plan may deny the benefit if the patient does not
provide the genetic information required to determine medical
appropriateness. If an individual is not seeking a benefit, the medical
appropriateness exception of this paragraph (d)(1)(iii) to the
definition of underwriting purposes does not apply. See paragraph (e)
of this section for examples illustrating the medical appropriateness
provisions of this paragraph (d)(1)(iii), as well as other provisions
of this section.
(2) Prior to or in connection with enrollment--(i) In general. A
group health plan must not collect genetic information with respect to
any individual prior to that individual's effective date of coverage
under that plan, nor in connection with the rules for eligibility (as
defined in Sec. 54.9802-1(b)(1)(ii)) that apply to that individual.
Whether or not an individual's information is collected prior to that
individual's effective date of coverage is determined at the time of
collection.
(ii) Incidental collection exception--(A) In general. If a group
health plan obtains genetic information incidental to the collection of
other information concerning any individual, the collection is not a
violation of this paragraph (d)(2), as long as the collection is not
for underwriting purposes in violation of paragraph (d)(1) of this
section.
(B) Limitation. The incidental collection exception of this
paragraph (d)(2)(ii) does not apply in connection with any collection
where it is reasonable to anticipate that health information will be
received, unless the collection explicitly states that genetic
information should not be provided.
(3) Examples. The rules of this paragraph (d) are illustrated by
the following examples:
Example 1. (i) Facts. A group health plan provides a premium
reduction to enrollees who complete a health risk assessment. The
health risk assessment is requested to be completed after
enrollment. Whether or not it is completed or what responses are
given on it has no effect on an individual's enrollment status, or
on the enrollment status of members of the individual's family. The
health risk assessment includes questions about the individual's
family medical history.
(ii) Conclusion. In this Example 1, the health risk assessment
includes a request for genetic information (that is, the
individual's family medical history). Because completing the health
risk assessment results in a premium reduction, the request for
genetic information is for underwriting purposes. Consequently, the
request violates the prohibition on the collection of genetic
information in paragraph (d)(1) of this section.
Example 2. (i) Facts. The same facts as Example 1, except there
is no premium reduction or any other reward for completing the
health risk assessment.
(ii) Conclusion. In this Example 2, the request is not for
underwriting purposes, nor is it prior to or in connection with
enrollment. Therefore, it does not violate the prohibition on the
collection of genetic information in this paragraph (d).
Example 3. (i) Facts. A group health plan requests that
enrollees complete a health risk assessment prior to enrollment, and
includes questions about the individual's family medical history.
There is no reward or penalty for completing the health risk
assessment.
(ii) Conclusion. In this Example 3, because the health risk
assessment includes a request for genetic information (that is, the
individual's family medical history), and requests the information
prior to enrollment, the request violates the prohibition on the
collection of genetic information in paragraph (d)(2) of this
section. Moreover, because it is a request for genetic information,
it is not an incidental collection under paragraph (d)(2)(ii) of
this section.
Example 4. (i) Facts. The facts are the same as in Example 1,
except there is no premium reduction or any other reward given for
completion of the health risk assessment. However, certain people
completing the health risk assessment may become eligible for
additional benefits under the plan by being enrolled in a disease
management program based on their answers to questions about family
medical history. Other people may become eligible for the disease
management program based solely on their answers to questions about
their individual medical history.
(ii) Conclusion. In this Example 4, the request for information
about an individual's family medical history could result in the
individual being eligible for benefits for which the individual
would not otherwise be eligible. Therefore, the questions about
family medical history on the health risk assessment are a request
for genetic information for underwriting purposes and are prohibited
under this paragraph (d). Although the plan conditions eligibility
for the disease management program based on determinations of
medical appropriateness, the exception for determinations of medical
appropriateness does not apply because the individual is not seeking
benefits.
Example 5. (i) Facts. A group health plan requests enrollees to
complete two distinct health risk assessments (HRAs) after and
unrelated to enrollment. The first HRA instructs the individual to
answer only for the individual and not for the individual's family.
The first HRA does not ask about any genetic tests the individual
has undergone or any genetic services the individual has received.
The plan offers a reward for completing the first HRA. The second
HRA asks about family medical history and the results of genetic
tests the individual has undergone. The plan offers no reward for
completing the second HRA and the instructions make clear that
completion of the second HRA is wholly voluntary and will not affect
the reward given for completion of the first HRA.
(ii) Conclusion. In this Example 5, no genetic information is
collected in
[[Page 51682]]
connection with the first HRA, which offers a reward, and no
benefits or other rewards are conditioned on the request for genetic
information in the second HRA. Consequently, the request for genetic
information in the second HRA is not for underwriting purposes, and
the two HRAs do not violate the prohibition on the collection of
genetic information in this paragraph (d).
Example 6. (i) Facts. A group health plan waives its annual
deductible for enrollees who complete an HRA. The HRA is requested
to be completed after enrollment. Whether or not the HRA is
completed or what responses are given on it has no effect on an
individual's enrollment status, or on the enrollment status of
members of the individual's family. The HRA does not include any
direct questions about the individual's genetic information
(including family medical history). However, the last question
reads, ``Is there anything else relevant to your health that you
would like us to know or discuss with you?''
(ii) Conclusion. In this Example 6, the plan's request for
medical information does not explicitly state that genetic
information should not be provided. Therefore, any genetic
information collected in response to the question is not within the
incidental collection exception and is prohibited under this
paragraph (d).
Example 7. (i) Facts. Same facts as Example 6, except that the
last question goes on to state, ``In answering this question, you
should not include any genetic information. That is, please do not
include any family medical history or any information related to
genetic testing, genetic services, genetic counseling, or genetic
diseases for which you believe you may be at risk.''
(ii) Conclusion. In this Example 7, the plan's request for
medical information explicitly states that genetic information
should not be provided. Therefore, any genetic information collected
in response to the question is within the incidental collection
exception. However, the plan may not use any genetic information it
obtains incidentally for underwriting purposes.
Example 8. (i) Facts. Issuer M acquires Issuer N. M requests N's
records, stating that N should not provide genetic information and
should review the records to excise any genetic information. N
assembles the data requested by M and, although N reviews it to
delete genetic information, the data from a specific region included
some individuals' family medical history. Consequently, M receives
genetic information about some of N's covered individuals.
(ii) Conclusion. In this Example 8, M's request for health
information explicitly stated that genetic information should not be
provided. See Example 8 in 29 CFR 2590.702-1(d)(3) or 45 CFR
146.122(d)(3) for a conclusion that the collection of genetic
information was within the incidental collection exception of 29 CFR
2590.702-1(d)(2)(ii) or 45 CFR 146.122(d)(ii) similar to the
incidental exception of paragraph (d)(2)(ii) of this section. See
Example 8 in 29 CFR 2590.702-1(d)(3) or 45 CFR 146.122(d)(3) also
for a caveat that M may not use the genetic information it obtained
incidentally for underwriting purposes.
(e) Examples regarding determinations of medical appropriateness.
The application of the rules of paragraphs (c) and (d) of this section
to plan determinations of medical appropriateness is illustrated by the
following examples:
Example 1. (i) Facts. Individual A's group health plan covers
genetic testing for celiac disease for individuals who have family
members with this condition. After A's son is diagnosed with celiac
disease, A undergoes a genetic test and promptly submits a claim for
the test to A's issuer for reimbursement. The issuer asks A to
provide the results of the genetic test before the claim is paid.
(ii) Conclusion. See Example 1 in 29 CFR 2590.702-1(e) or 45 CFR
146.122(e) for a conclusion under the rules of paragraph (c)(4) of
29 CFR 2590.702-1 or 45 CFR 146.122 similar to the rules of
paragraph (c)(4) of this section that the issuer is permitted to
request only the minimum amount of information necessary to make a
decision regarding payment. Because the results of the test are not
necessary for the issuer to make a decision regarding the payment of
A's claim, the conclusion in Example 1 in 29 CFR 2590.702-1(e) or 45
CFR 146.122(e) concludes that the issuer's request for the results
of the genetic test violates paragraph (c) of 29 CFR 2590.702-1 or
45 CFR 146.122 similar to paragraph (c) of this section.
Example 2. (i) Facts. Individual B's group health plan covers a
yearly mammogram for participants and beneficiaries starting at age
40, or at age 30 for those with increased risk for breast cancer,
including individuals with BRCA1 or BRCA2 gene mutations. B is 33
years old and has the BRCA2 mutation. B undergoes a mammogram and
promptly submits a claim to B's plan for reimbursement. Following an
established policy, the plan asks B for evidence of increased risk
of breast cancer, such as the results of a genetic test or a family
history of breast cancer, before the claim for the mammogram is
paid. This policy is applied uniformly to all similarly situated
individuals and is not directed at individuals based on any genetic
information.
(ii) Conclusion. In this Example 2, the plan does not violate
paragraphs (c) or (d) of this section. Under paragraph (c), the plan
is permitted to request and use the results of a genetic test to
make a determination regarding payment, provided the plan requests
only the minimum amount of information necessary. Because the
medical appropriateness of the mammogram depends on the genetic
makeup of the patient, the minimum amount of information necessary
includes the results of the genetic test. Similarly, the plan does
not violate paragraph (d) of this section because the plan is
permitted to request genetic information in making a determination
regarding the medical appropriateness of a claim if the genetic
information is necessary to make the determination (and if the
genetic information is not used for underwriting purposes).
Example 3. (i) Facts. Individual C was previously diagnosed with
and treated for breast cancer, which is currently in remission. In
accordance with the recommendation of C's physician, C has been
taking a regular dose of tamoxifen to help prevent a recurrence. C's
group health plan adopts a new policy requiring patients taking
tamoxifen to undergo a genetic test to ensure that tamoxifen is
medically appropriate for their genetic makeup. In accordance with,
at the time, the latest scientific research, tamoxifen is not
helpful in up to 7 percent of breast cancer patients, those with
certain variations of the gene for making the CYP2D6
enzyme. If a patient has a gene variant making tamoxifen not
medically appropriate, the plan does not pay for the tamoxifen
prescription.
(ii) Conclusion. In this Example 3, the plan does not violate
paragraph (c) of this section if it conditions future payments for
the tamoxifen prescription on C's undergoing a genetic test to
determine what genetic markers C has for making the
CYP2D6 enzyme. Nor does the plan violate paragraph (c) of
this section if the plan refuses future payment if the results of
the genetic test indicate that tamoxifen is not medically
appropriate for C.
Example 4. (i) Facts. A group health plan offers a diabetes
disease management program to all similarly situated individuals for
whom it is medically appropriate based on whether the individuals
have or are at risk for diabetes. The program provides enhanced
benefits related only to diabetes for individuals who qualify for
the program. The plan sends out a notice to all participants that
describes the diabetes disease management program and explains the
terms for eligibility. Individuals interested in enrolling in the
program are advised to contact the plan to demonstrate that they
have diabetes or that they are at risk for diabetes. For individuals
who do not currently have diabetes, genetic information may be used
to demonstrate that an individual is at risk.
(ii) Conclusion. In this Example 4, the plan may condition
benefits under the disease management program upon a showing by an
individual that the individual is at risk for diabetes, even if such
showing may involve genetic information, provided that the plan
requests genetic information only when necessary to make a
determination regarding whether the disease management program is
medically appropriate for the individual and only requests the
minimum amount of information necessary to make that determination.
Example 5. (i) Facts. Same facts as Example 4, except that the
plan includes a questionnaire that asks about the occurrence of
diabetes in members of the individual's family as part of the notice
describing the disease management program.
(ii) Conclusion. In this Example 5, the plan violates the
requirements of paragraph (d)(1) of this section because the
requests for genetic information are not limited to those situations
in which it is necessary to make a determination regarding whether
the disease management program is medically appropriate for the
individuals.
Example 6. (i) Facts. Same facts as Example 4, except the
disease management program provides an enhanced benefit in the
[[Page 51683]]
form of a lower annual deductible to individuals under the program;
the lower deductible applies with respect to all medical expenses
incurred by the individual. Thus, whether or not a claim relates to
diabetes, the individual is provided with a lower deductible based
on the individual providing the plan with genetic information.
(ii) Conclusion. In this Example 6, because the enhanced
benefits include benefits not related to the determination of
medical appropriateness, making available the enhanced benefits is
within the meaning of underwriting purposes. Accordingly, the plan
may not request or require genetic information (including family
history information) in determining eligibility for enhanced
benefits under the program because such a request would be for
underwriting purposes and would violate paragraph (d)(1) of this
section.
(f) Effective/applicability date. This section applies for plan
years beginning on or after December 7, 2009.
(g) Expiration date. This section expires on or before October 1,
2012.
Linda E. Stiff,
Deputy Commissioner for Services and Enforcement, Internal Revenue
Service.
Approved: September 11, 2009.
Michael Mundaca,
Acting Assistant Secretary of the Treasury (Tax Policy).
Employee Benefits Security Administration
29 CFR Chapter XXV
0
For the reasons stated in the preamble, 29 CFR Part 2590 is amended as
follows:
PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS
0
1. The authority citation for Part 2590 is amended to read as follows:
Authority: 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-
1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c;
sec. 101(g), Public Law 104-191, 110 Stat. 1936; sec. 401(b), Public
Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 101(f), Public
Law 110-233, 122 Stat. 881; Secretary of Labor's Order 1-2003, 68 FR
5374 (Feb. 3, 2003).
0
2. Section 2590.701-1 is amended by revising paragraph (b)(6) and
adding paragraph (b)(7) to read as follows:
Sec. 2590.701-1 Basis and scope.
* * * * *
(b) * * *
(6) Additional requirements prohibiting discrimination based on
genetic information.
(7) Use of an affiliation period by an HMO as an alternative to a
preexisting condition exclusion.
* * * * *
0
3. Section 2590.701-2 is amended by revising the definition of genetic
information to read as follows:
Sec. 2590.701-2 Definitions.
* * * * *
Genetic information has the meaning given the term in Sec.
2590.702-1(a)(3) of this Part.
* * * * *
0
4. Section 2590.702 is amended by revising paragraphs (a)(1)(vi),
(c)(2)(i), and (c)(2)(iii) to read as follows:
Sec. 2590.702 Prohibiting discrimination against participants and
beneficiaries based on a health factor.
(a) * * *
(1) * * *
(vi) Genetic information, as defined in Sec. 2590.702-1(a)(3) of
this Part.
* * * * *
(c) * * *
(2) * * * (i) Group rating based on health factors not restricted
under this section. Nothing in this section restricts the aggregate
amount that an employer may be charged for coverage under a group
health plan. But see Sec. 2590.702-1(b) of this Part, which prohibits
adjustments in group premium or contribution rates based on genetic
information.
* * * * *
(iii) Examples. The rules of this paragraph (c)(2) are illustrated
by the following examples:
Example 1. (i) Facts. An employer sponsors a group health plan
and purchases coverage from a health insurance issuer. In order to
determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan.
The issuer finds that Individual F had significantly higher claims
experience than similarly situated individuals in the plan. The
issuer quotes the plan a higher per-participant rate because of F's
claims experience.
(ii) Conclusion. In this Example 1, the issuer does not violate
the provisions of this paragraph (c)(2) because the issuer blends
the rate so that the employer is not quoted a higher rate for F than
for a similarly situated individual based on F's claims experience.
(However, if the issuer used genetic information in computing the
group rate, it would violate Sec. 2590.702-1(b) of this Part.)
* * * * *
0
5. Add Sec. 2590.702-1 to read as follows:
Sec. 2590.702-1 Additional requirements prohibiting discrimination
based on genetic information.
(a) Definitions. Unless otherwise provided, the definitions in this
paragraph (a) govern in applying the provisions of this section.
(1) Collect means, with respect to information, to request,
require, or purchase such information.
(2) Family member means, with respect to an individual--
(i) A dependent (as defined for purposes of Sec. 2590.701-2 of
this Part) of the individual; or
(ii) Any other person who is a first-degree, second-degree, third-
degree, or fourth-degree relative of the individual or of a dependent
of the individual. Relatives by affinity (such as by marriage or
adoption) are treated the same as relatives by consanguinity (that is,
relatives who share a common biological ancestor). In determining the
degree of the relationship, relatives by less than full consanguinity
(such as half-siblings, who share only one parent) are treated the same
as relatives by full consanguinity (such as siblings who share both
parents).
(A) First-degree relatives include parents, spouses, siblings, and
children.
(B) Second-degree relatives include grandparents, grandchildren,
aunts, uncles, nephews, and nieces.
(C) Third-degree relatives include great-grandparents, great-
grandchildren, great aunts, great uncles, and first cousins.
(D) Fourth-degree relatives include great-great grandparents,
great-great grandchildren, and children of first cousins.
(3) Genetic information means--(i) Subject to paragraphs (a)(3)(ii)
and (a)(3)(iii) of this section, with respect to an individual,
information about--
(A) The individual's genetic tests (as defined in paragraph (a)(5)
of this section);
(B) The genetic tests of family members of the individual;
(C) The manifestation (as defined in paragraph (a)(6) of this
section) of a disease or disorder in family members of the individual;
or
(D) Any request for, or receipt of, genetic services (as defined in
paragraph (a)(4) of this section), or participation in clinical
research which includes genetic services, by the individual or any
family member of the individual.
(ii) The term genetic information does not include information
about the sex or age of any individual.
(iii) The term genetic information includes--
(A) With respect to a pregnant woman (or a family member of the
pregnant woman), genetic information of any fetus carried by the
pregnant woman; and
(B) With respect to an individual (or a family member of the
individual) who is utilizing an assisted reproductive technology,
genetic information of any
[[Page 51684]]
embryo legally held by the individual or family member.
(4) Genetic services means--
(i) A genetic test, as defined in paragraph (a)(5) of this section;
(ii) Genetic counseling (including obtaining, interpreting, or
assessing genetic information); or
(iii) Genetic education.
(5)(i) Genetic test means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, if the analysis detects
genotypes, mutations, or chromosomal changes. However, a genetic test
does not include an analysis of proteins or metabolites that is
directly related to a manifested disease, disorder, or pathological
condition. Accordingly, a test to determine whether an individual has a
BRCA1 or BRCA2 variant is a genetic test. Similarly, a test to
determine whether an individual has a genetic variant associated with
hereditary nonpolyposis colorectal cancer is a genetic test. However,
an HIV test, complete blood count, cholesterol test, liver function
test, or test for the presence of alcohol or drugs is not a genetic
test.
(ii) The rules of this paragraph (a)(5) are illustrated by the
following example:
Example. (i) Facts. Individual A is a newborn covered under a
group health plan. A undergoes a phenylketonuria (PKU) screening,
which measures the concentration of a metabolite, phenylalanine, in
A's blood. In PKU, a mutation occurs in the phenylalanine
hydroxylase (PAH) gene which contains instructions for making the
enzyme needed to break down the amino acid phenylalanine.
Individuals with the mutation, who have a deficiency in the enzyme
to break down phenylalanine, have high concentrations of
phenylalanine.
(ii) Conclusion. In this Example, the PKU screening is a genetic
test with respect to A because the screening is an analysis of
metabolites that detects a genetic mutation.
(6)(i) Manifestation or manifested means, with respect to a
disease, disorder, or pathological condition, that an individual has
been or could reasonably be diagnosed with the disease, disorder, or
pathological condition by a health care professional with appropriate
training and expertise in the field of medicine involved. For purposes
of this section, a disease, disorder, or pathological condition is not
manifested if a diagnosis is based principally on genetic information.
(ii) The rules of this paragraph (a)(6) are illustrated by the
following examples:
Example 1. (i) Facts. Individual A has a family medical history
of diabetes. A begins to experience excessive sweating, thirst, and
fatigue. A's physician examines A and orders blood glucose testing
(which is not a genetic test). Based on the physician's examination,
A's symptoms, and test results that show elevated levels of blood
glucose, A's physician diagnoses A as having adult onset diabetes
mellitus (Type 2 diabetes).
(ii) Conclusion. In this Example 1, A has been diagnosed by a
health care professional with appropriate training and expertise in
the field of medicine involved. The diagnosis is not based
principally on genetic information. Thus, Type 2 diabetes is
manifested with respect to A.
Example 2. (i) Facts. Individual B has several family members
with colon cancer. One of them underwent genetic testing which
detected a mutation in the MSH2 gene associated with hereditary
nonpolyposis colorectal cancer (HNPCC). B's physician, a health care
professional with appropriate training and expertise in the field of
medicine involved, recommends that B undergo a targeted genetic test
to look for the specific mutation found in B's relative to determine
if B has an elevated risk for cancer. The genetic test with respect
to B showed that B also carries the mutation and is at increased
risk to develop colorectal and other cancers associated with HNPCC.
B has a colonoscopy which indicates no signs of disease, and B has
no symptoms.
(ii) Conclusion. In this Example 2, because B has no signs or
symptoms of colorectal cancer, B has not been and could not
reasonably be diagnosed with HNPCC. Thus, HNPCC is not manifested
with respect to B.
Example 3. (i) Facts. Same facts as Example 2, except that B's
colonoscopy and subsequent tests indicate the presence of HNPCC.
Based on the colonoscopy and subsequent test results, B's physician
makes a diagnosis of HNPCC.
(ii) Conclusion. In this Example 3, HNPCC is manifested with
respect to B because a health care professional with appropriate
training and expertise in the field of medicine involved has made a
diagnosis that is not based principally on genetic information.
Example 4. (i) Facts. Individual C has a family member that has
been diagnosed with Huntington's Disease. A genetic test indicates
that C has the Huntington's Disease gene variant. At age 42, C
begins suffering from occasional moodiness and disorientation,
symptoms which are associated with Huntington's Disease. C is
examined by a neurologist (a physician with appropriate training and
expertise for diagnosing Huntington's Disease). The examination
includes a clinical neurological exam. The results of the
examination do not support a diagnosis of Huntington's Disease.
(ii) Conclusion. In this Example 4, C is not and could not
reasonably be diagnosed with Huntington's Disease by a health care
professional with appropriate training and expertise. Therefore,
Huntington's Disease is not manifested with respect to C.
Example 5. (i) Facts. Same facts as Example 4, except that C
exhibits additional neurological and behavioral symptoms, and the
results of the examination support a diagnosis of Huntington's
Disease with respect to C.
(ii) Conclusion. In this Example 5, C could reasonably be
diagnosed with Huntington's Disease by a health care professional
with appropriate training and expertise. Therefore, Huntington's
Disease is manifested with respect to C.
(7) Underwriting purposes has the meaning given in paragraph (d)(1)
of this section.
(b) No group-based discrimination based on genetic information--(1)
In general. For purposes of this section, a group health plan, and a
health insurance issuer offering health insurance coverage in
connection with a group health plan, must not adjust premium or
contribution amounts for the plan, or any group of similarly situated
individuals under the plan, on the basis of genetic information. For
this purpose, ``similarly situated individuals'' are those described in
Sec. 2590.702(d) of this Part.
(2) Rule of construction. Nothing in paragraph (b)(1) of this
section (or in paragraph (d)(1) or (d)(2) of this section) limits the
ability of a health insurance issuer offering health insurance coverage
in connection with a group health plan to increase the premium for a
group health plan or a group of similarly situated individuals under
the plan based on the manifestation of a disease or disorder of an
individual who is enrolled in the plan. In such a case, however, the
manifestation of a disease or disorder in one individual cannot also be
used as genetic information about other group members to further
increase the premium for a group health plan or a group of similarly
situated individuals under the plan.
(3) Examples. The rules of this paragraph (b) are illustrated by
the following examples:
Example 1. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that three individuals covered
under the plan had unusually high claims experience. In addition,
the issuer finds that the genetic information of two other
individuals indicates the individuals have a higher probability of
developing certain illnesses although the illnesses are not
manifested at this time. The issuer quotes the plan a higher per-
participant rate because of both the genetic information and the
higher claims experience.
(ii) Conclusion. In this Example 1, the issuer violates the
provisions of this paragraph (b) because the issuer adjusts the
premium based on genetic information. However, if the adjustment
related solely to claims experience, the adjustment would not
violate the requirements of this section (nor would it violate the
requirements of paragraph (c) of Sec. 2590.702 of this Part,
[[Page 51685]]
which prohibits discrimination in individual premiums or
contributions based on a health factor but permits increases in the
group rate based on a health factor).
Example 2. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that Employee A has made
claims for treatment of polycystic kidney disease. A also has two
dependent children covered under the plan. The issuer quotes the
plan a higher per-participant rate because of both A's claims
experience and the family medical history of A's children (that is,
the fact that A has the disease).
(ii) Conclusion. In this Example 2, the issuer violates the
provisions of this paragraph (b) because, by taking the likelihood
that A's children may develop polycystic kidney disease into account
in computing the rate for the plan, the issuer adjusts the premium
based on genetic information relating to a condition that has not
been manifested in A's children. However, it is permissible for the
issuer to increase the premium based on A's claims experience.
(c) Limitation on requesting or requiring genetic testing--(1)
General rule. Except as otherwise provided in this paragraph (c), a
group health plan, and a health insurance issuer offering health
insurance coverage in connection with a group health plan, must not
request or require an individual or a family member of the individual
to undergo a genetic test.
(2) Health care professional may recommend a genetic test. Nothing
in paragraph (c)(1) of this section limits the authority of a health
care professional who is providing health care services to an
individual to request that the individual undergo a genetic test.
(3) Examples. The rules of paragraphs (c)(1) and (2) of this
section are illustrated by the following examples:
Example 1. (i) Facts. Individual A goes to a physician for a
routine physical examination. The physician reviews A's family
medical history and A informs the physician that A's mother has been
diagnosed with Huntington's Disease. The physician advises A that
Huntington's Disease is hereditary and recommends that A undergo a
genetic test.
(ii) Conclusion. In this Example 1, the physician is a health
care professional who is providing health care services to A.
Therefore, the physician's recommendation that A undergo the genetic
test does not violate this paragraph (c).
Example 2. (i) Facts. Individual B is covered by a health
maintenance organization (HMO). B is a child being treated for
leukemia. B's physician, who is employed by the HMO, is considering
a treatment plan that includes six-mercaptopurine, a drug for
treating leukemia in most children. However, the drug could be fatal
if taken by a small percentage of children with a particular gene
variant. B's physician recommends that B undergo a genetic test to
detect this variant before proceeding with this course of treatment.
(ii) Conclusion. In this Example 2, even though the physician is
employed by the HMO, the physician is nonetheless a health care
professional who is providing health care services to B. Therefore,
the physician's recommendation that B undergo the genetic test does
not violate this paragraph (c).
(4) Determination regarding payment. (i) In general. As provided in
this paragraph (c)(4), nothing in paragraph (c)(1) of this section
precludes a plan or issuer from obtaining and using the results of a
genetic test in making a determination regarding payment. For this
purpose, ``payment'' has the meaning given such term in 45 CFR 164.501
of the privacy regulations issued under the Health Insurance
Portability and Accountability Act. Thus, if a plan or issuer
conditions payment for an item or service based on its medical
appropriateness and the medical appropriateness of the item or service
depends on the genetic makeup of a patient, then the plan or issuer is
permitted to condition payment for the item or service on the outcome
of a genetic test. The plan or issuer may also refuse payment if the
patient does not undergo the genetic test.
(ii) Limitation. A plan or issuer is permitted to request only the
minimum amount of information necessary to make a determination
regarding payment. The minimum amount of information necessary is
determined in accordance with the minimum necessary standard in 45 CFR
164.502(b) of the privacy regulations issued under the Health Insurance
Portability and Accountability Act.
(iii) Examples. See paragraph (e) of this section for examples
illustrating the rules of this paragraph (c)(4), as well as other
provisions of this section.
(5) Research exception. Notwithstanding paragraph (c)(1) of this
section, a plan or issuer may request, but not require, that a
participant or beneficiary undergo a genetic test if all of the
conditions of this paragraph (c)(5) are met:
(i) Research in accordance with Federal regulations and applicable
State or local law or regulations. The plan or issuer makes the request
pursuant to research, as defined in 45 CFR 46.102(d), that complies
with 45 CFR Part 46 or equivalent Federal regulations, and any
applicable State or local law or regulations for the protection of
human subjects in research.
(ii) Written request for participation in research. The plan or
issuer makes the request in writing, and the request clearly indicates
to each participant or beneficiary (or, in the case of a minor child,
to the legal guardian of the beneficiary) that--
(A) Compliance with the request is voluntary; and
(B) Noncompliance will have no effect on eligibility for benefits
(as described in Sec. 2590.702(b)(1) of this Part) or premium or
contribution amounts.
(iii) Prohibition on underwriting. No genetic information collected
or acquired under this paragraph (c)(5) can be used for underwriting
purposes (as described in paragraph (d)(1) of this section).
(iv) Notice to Federal agencies. The plan or issuer completes a
copy of the ``Notice of Research Exception under the Genetic
Information Nondiscrimination Act'' authorized by the Secretary and
provides the notice to the address specified in the instructions
thereto.
(d) Prohibitions on collection of genetic information--(1) For
underwriting purposes--(i) General rule. A group health plan, and a
health insurance issuer offering health insurance coverage in
connection with a group health plan, must not collect (as defined in
paragraph (a)(1) of this section) genetic information for underwriting
purposes. See paragraph (e) of this section for examples illustrating
the rules of this paragraph (d)(1), as well as other provisions of this
section.
(ii) Underwriting purposes defined. Subject to paragraph
(d)(1)(iii) of this section, underwriting purposes means, with respect
to any group health plan, or health insurance coverage offered in
connection with a group health plan--
(A) Rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the plan or
coverage as described in Sec. 2590.702(b)(1)(ii) of this Part
(including changes in deductibles or other cost-sharing mechanisms in
return for activities such as completing a health risk assessment or
participating in a wellness program);
(B) The computation of premium or contribution amounts under the
plan or coverage (including discounts, rebates, payments in kind, or
other premium differential mechanisms in return for activities such as
completing a health risk assessment or participating in a wellness
program);
[[Page 51686]]
(C) The application of any preexisting condition exclusion under
the plan or coverage; and
(D) Other activities related to the creation, renewal, or
replacement of a contract of health insurance or health benefits.
(iii) Medical appropriateness. If an individual seeks a benefit
under a group health plan or health insurance coverage, the plan or
coverage may limit or exclude the benefit based on whether the benefit
is medically appropriate, and the determination of whether the benefit
is medically appropriate is not within the meaning of underwriting
purposes. Accordingly, if an individual seeks a benefit under the plan
and the plan or issuer conditions the benefit based on its medical
appropriateness and the medical appropriateness of the benefit depends
on genetic information of the individual, then the plan or issuer is
permitted to condition the benefit on the genetic information. A plan
or issuer is permitted to request only the minimum amount of genetic
information necessary to determine medical appropriateness. The plan or
issuer may deny the benefit if the patient does not provide the genetic
information required to determine medical appropriateness. If an
individual is not seeking a benefit, the medical appropriateness
exception of this paragraph (d)(1)(iii) to the definition of
underwriting purposes does not apply. See paragraph (e) of this section
for examples illustrating the medical appropriateness provisions of
this paragraph (d)(1)(iii), as well as other provisions of this
section.
(2) Prior to or in connection with enrollment. (i) In general. A
group health plan, and a health insurance issuer offering health
insurance coverage in connection with a group health plan, must not
collect genetic information with respect to any individual prior to
that individual's effective date of coverage under that plan or
coverage, nor in connection with the rules for eligibility (as defined
in Sec. 2590.702(b)(1)(ii) of this Part) that apply to that
individual. Whether or not an individual's information is collected
prior to that individual's effective date of coverage is determined at
the time of collection.
(ii) Incidental collection exception.--(A) In general. If a group
health plan, or a health insurance issuer offering health insurance
coverage in connection with a group health plan, obtains genetic
information incidental to the collection of other information
concerning any individual, the collection is not a violation of this
paragraph (d)(2), as long as the collection is not for underwriting
purposes in violation of paragraph (d)(1) of this section.
(B) Limitation. The incidental collection exception of this
paragraph (d)(2)(ii) does not apply in connection with any collection
where it is reasonable to anticipate that health information will be
received, unless the collection explicitly states that genetic
information should not be provided.
(3) Examples. The rules of this paragraph (d) are illustrated by
the following examples:
Example 1. (i) Facts. A group health plan provides a premium
reduction to enrollees who complete a health risk assessment. The
health risk assessment is requested to be completed after
enrollment. Whether or not it is completed or what responses are
given on it has no effect on an individual's enrollment status, or
on the enrollment status of members of the individual's family. The
health risk assessment includes questions about the individual's
family medical history.
(ii) Conclusion. In this Example 1, the health risk assessment
includes a request for genetic information (that is, the
individual's family medical history). Because completing the health
risk assessment results in a premium reduction, the request for
genetic information is for underwriting purposes. Consequently, the
request violates the prohibition on the collection of genetic
information in paragraph (d)(1) of this section.
Example 2. (i) Facts. The same facts as Example 1, except there
is no premium reduction or any other reward for completing the
health risk assessment.
(ii) Conclusion. In this Example 2, the request is not for
underwriting purposes, nor is it prior to or in connection with
enrollment. Therefore, it does not violate the prohibition on the
collection of genetic information in this paragraph (d).
Example 3. (i) Facts. A group health plan requests that
enrollees complete a health risk assessment prior to enrollment, and
includes questions about the individual's family medical history.
There is no reward or penalty for completing the health risk
assessment.
(ii) Conclusion. In this Example 3, because the health risk
assessment includes a request for genetic information (that is, the
individual's family medical history), and requests the information
prior to enrollment, the request violates the prohibition on the
collection of genetic information in paragraph (d)(2) of this
section. Moreover, because it is a request for genetic information,
it is not an incidental collection under paragraph (d)(2)(ii) of
this section.
Example 4. (i) Facts. The facts are the same as in Example 1,
except there is no premium reduction or any other reward given for
completion of the health risk assessment. However, certain people
completing the health risk assessment may become eligible for
additional benefits under the plan by being enrolled in a disease
management program based on their answers to questions about family
medical history. Other people may become eligible for the disease
management program based solely on their answers to questions about
their individual medical history.
(ii) Conclusion. In this Example 4, the request for information
about an individual's family medical history could result in the
individual being eligible for benefits for which the individual
would not otherwise be eligible. Therefore, the questions about
family medical history on the health risk assessment are a request
for genetic information for underwriting purposes and are prohibited
under this paragraph (d). Although the plan conditions eligibility
for the disease management program based on determinations of
medical appropriateness, the exception for determinations of medical
appropriateness does not apply because the individual is not seeking
benefits.
Example 5. (i) Facts. A group health plan requests enrollees to
complete two distinct health risk assessments (HRAs) after and
unrelated to enrollment. The first HRA instructs the individual to
answer only for the individual and not for the individual's family.
The first HRA does not ask about any genetic tests the individual
has undergone or any genetic services the individual has received.
The plan offers a reward for completing the first HRA. The second
HRA asks about family medical history and the results of genetic
tests the individual has undergone. The plan offers no reward for
completing the second HRA and the instructions make clear that
completion of the second HRA is wholly voluntary and will not affect
the reward given for completion of the first HRA.
(ii) Conclusion. In this Example 5, no genetic information is
collected in connection with the first HRA, which offers a reward,
and no benefits or other rewards are conditioned on the request for
genetic information in the second HRA. Consequently, the request for
genetic information in the second HRA is not for underwriting
purposes, and the two HRAs do not violate the prohibition on the
collection of genetic information in this paragraph (d).
Example 6. (i) Facts. A group health plan waives its annual
deductible for enrollees who complete an HRA. The HRA is requested
to be completed after enrollment. Whether or not the HRA is
completed or what responses are given on it has no effect on an
individual's enrollment status, or on the enrollment status of
members of the individual's family. The HRA does not include any
direct questions about the individual's genetic information
(including family medical history). However, the last question
reads, ``Is there anything else relevant to your health that you
would like us to know or discuss with you?''
(ii) Conclusion. In this Example 6, the plan's request for
medical information does not explicitly state that genetic
information should not be provided. Therefore, any genetic
information collected in response to the question is not within the
incidental collection exception and is prohibited under this
paragraph (d).
Example 7. (i) Facts. Same facts as Example 6, except that the
last question goes on to state, ``In answering this question, you
[[Page 51687]]
should not include any genetic information. That is, please do not
include any family medical history or any information related to
genetic testing, genetic services, genetic counseling, or genetic
diseases for which you believe you may be at risk.''
(ii) Conclusion. In this Example 7, the plan's request for
medical information explicitly states that genetic information
should not be provided. Therefore, any genetic information collected
in response to the question is within the incidental collection
exception. However, the plan may not use any genetic information it
obtains incidentally for underwriting purposes.
Example 8. (i) Facts. Issuer M acquires Issuer N. M requests N's
records, stating that N should not provide genetic information and
should review the records to excise any genetic information. N
assembles the data requested by M and, although N reviews it to
delete genetic information, the data from a specific region included
some individuals' family medical history. Consequently, M receives
genetic information about some of N's covered individuals.
(ii) Conclusion. In this Example 8, M's request for health
information explicitly stated that genetic information should not be
provided. Therefore, the collection of genetic information was
within the incidental collection exception. However, M may not use
the genetic information it obtained incidentally for underwriting
purposes.
(e) Examples regarding determinations of medical appropriateness.
The application of the rules of paragraphs (c) and (d) of this section
to plan or issuer determinations of medical appropriateness is
illustrated by the following examples:
Example 1. (i) Facts. Individual A's group health plan covers
genetic testing for celiac disease for individuals who have family
members with this condition. After A's son is diagnosed with celiac
disease, A undergoes a genetic test and promptly submits a claim for
the test to A's issuer for reimbursement. The issuer asks A to
provide the results of the genetic test before the claim is paid.
(ii) Conclusion. In this Example 1, under the rules of paragraph
(c)(4) of this section the issuer is permitted to request only the
minimum amount of information necessary to make a decision regarding
payment. Because the results of the test are not necessary for the
issuer to make a decision regarding the payment of A's claim, the
issuer's request for the results of the genetic test violates
paragraph (c) of this section.
Example 2. (i) Facts. Individual B's group health plan covers a
yearly mammogram for participants and beneficiaries starting at age
40, or at age 30 for those with increased risk for breast cancer,
including individuals with BRCA1 or BRCA2 gene mutations. B is 33
years old and has the BRCA2 mutation. B undergoes a mammogram and
promptly submits a claim to B's plan for reimbursement. Following an
established policy, the plan asks B for evidence of increased risk
of breast cancer, such as the results of a genetic test or a family
history of breast cancer, before the claim for the mammogram is
paid. This policy is applied uniformly to all similarly situated
individuals and is not directed at individuals based on any genetic
information.
(ii) Conclusion. In this Example 2, the plan does not violate
paragraphs (c) or (d) of this section. Under paragraph (c), the plan
is permitted to request and use the results of a genetic test to
make a determination regarding payment, provided the plan requests
only the minimum amount of information necessary. Because the
medical appropriateness of the mammogram depends on the genetic
makeup of the patient, the minimum amount of information necessary
includes the results of the genetic test. Similarly, the plan does
not violate paragraph (d) of this section because the plan is
permitted to request genetic information in making a determination
regarding the medical appropriateness of a claim if the genetic
information is necessary to make the determination (and if the
genetic information is not used for underwriting purposes).
Example 3. (i) Facts. Individual C was previously diagnosed with
and treated for breast cancer, which is currently in remission. In
accordance with the recommendation of C's physician, C has been
taking a regular dose of tamoxifen to help prevent a recurrence. C's
group health plan adopts a new policy requiring patients taking
tamoxifen to undergo a genetic test to ensure that tamoxifen is
medically appropriate for their genetic makeup. In accordance with,
at the time, the latest scientific research, tamoxifen is not
helpful in up to 7 percent of breast cancer patients, those with
certain variations of the gene for making the CYP2D6
enzyme. If a patient has a gene variant making tamoxifen not
medically appropriate, the plan does not pay for the tamoxifen
prescription.
(ii) Conclusion. In this Example 3, the plan does not violate
paragraph (c) of this section if it conditions future payments for
the tamoxifen prescription on C's undergoing a genetic test to
determine what genetic markers C has for making the
CYP2D6 enzyme. Nor does the plan violate paragraph (c) of
this section if the plan refuses future payment if the results of
the genetic test indicate that tamoxifen is not medically
appropriate for C.
Example 4. (i) Facts. A group health plan offers a diabetes
disease management program to all similarly situated individuals for
whom it is medically appropriate based on whether the individuals
have or are at risk for diabetes. The program provides enhanced
benefits related only to diabetes for individuals who qualify for
the program. The plan sends out a notice to all participants that
describes the diabetes disease management program and explains the
terms for eligibility. Individuals interested in enrolling in the
program are advised to contact the plan to demonstrate that they
have diabetes or that they are at risk for diabetes. For individuals
who do not currently have diabetes, genetic information may be used
to demonstrate that an individual is at risk.
(ii) Conclusion. In this Example 4, the plan may condition
benefits under the disease management program upon a showing by an
individual that the individual is at risk for diabetes, even if such
showing may involve genetic information, provided that the plan
requests genetic information only when necessary to make a
determination regarding whether the disease management program is
medically appropriate for the individual and only requests the
minimum amount of information necessary to make that determination.
Example 5. (i) Facts. Same facts as Example 4, except that the
plan includes a questionnaire that asks about the occurrence of
diabetes in members of the individual's family as part of the notice
describing the disease management program.
(ii) Conclusion. In this Example 5, the plan violates the
requirements of paragraph (d)(1) of this section because the
requests for genetic information are not limited to those situations
in which it is necessary to make a determination regarding whether
the disease management program is medically appropriate for the
individuals.
Example 6. (i) Facts. Same facts as Example 4, except the
disease management program provides an enhanced benefit in the form
of a lower annual deductible to individuals under the program; the
lower deductible applies with respect to all medical expenses
incurred by the individual. Thus, whether or not a claim relates to
diabetes, the individual is provided with a lower deductible based
on the individual providing the plan with genetic information.
(ii) Conclusion. In this Example 6, because the enhanced
benefits include benefits not related to the determination of
medical appropriateness, making available the enhanced benefits is
within the meaning of underwriting purposes. Accordingly, the plan
may not request or require genetic information (including family
history information) in determining eligibility for enhanced
benefits under the program because such a request would be for
underwriting purposes and would violate paragraph (d)(1) of this
section.
(f) Applicability date. This section applies for plan years
beginning on or after December 7, 2009.
0
6. Section 2590.732 is amended to revise paragraph (b) as follows:
Sec. 2590.732 Special rules relating to group health plans.
* * * * *
(b) General exception for certain small group health plans--(1)
Subject to paragraph (b)(2) of this section, the requirements of this
part do not apply to any group health plan (and group health insurance
coverage) for any plan year, if on the first day of the plan year, the
plan has fewer than two participants who are current employees.
(2) The following requirements apply without regard to paragraph
(b)(1) of this section:
(i) Section 2590.701-3(b)(6) of this Part.
(ii) Section 2590.702(b) of this Part, as such section applies with
respect to genetic information as a health factor.
[[Page 51688]]
(iii) Section 2590.702(c) of this Part, as such section applies
with respect to genetic information as a health factor.
(iv) Section 2590.702(e) of this Part, as such section applies with
respect to genetic information as a health factor.
(v) Section 2590.702-1(b) of this Part.
(vi) Section 2590.702-1(c) of this Part.
(vii) Section 2590.702-1(d) of this Part.
(viii) Section 2590.702-1(e) of this Part.
(ix) Section 2590.711 of this Part.
* * * * *
Signed at Washington, DC, this 21st day of August 2009.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits Security Administration, U.S.
Department of Labor.
Department of Health and Human Services
45 CFR Subtitle A
0
For the reasons set forth in the preamble, the Department of Health and
Human Services is amending 45 CFR Subtitle A, Subchapter B as set forth
below:
PART 144--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
0
1. The authority citation for part 144 is revised to read as follows:
Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public
Health Service Act, 42 U.S.C. 300gg through 300gg-63, 300gg-91, and
300gg-92.
Sec. 144.101 Basis and purpose.
0
2. Section 144.101 is amended by revising paragraph (a) to read as
follows:
(a) Part 146 of this subchapter implements sections 2701 through
2723, 2791 and 2792 of the Public Health Service Act (PHS Act, 42
U.S.C. 300gg through 42 U.S.C. 300gg-23, 300gg-91, and 300gg-92.).
* * * * *
0
3. Section 144.103 is amended by revising the definition of ``genetic
information'' to read as follows:
Sec. 144.103 Definitions.
* * * * *
Genetic information has the meaning specified in Sec. 146.122(a)
of this subchapter.
* * * * *
PART 146--REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET
0
4. The authority citation for part 146 is revised to read as follows:
Authority: Secs. 2702 through 2705, 2711 through 2723, 2791, and
2792 of the PHS Act (42 U.S.C. 300gg-1 through 300gg-5, 300gg-11
through 300gg-23, 300gg-91, and 300gg-92).
0
5. Section 146.101 is amended by--
0
A. Revising the first sentence of paragraph (a).
0
B. Adding a new paragraph (b)(1)(vii).
The revision and addition read as follows:
Sec. 146.101 Basis and scope.
(a) * * *. This part implements sections 2701 through 2723, 2791,
and 2792 of the PHS Act. * * *
(b) * * *
(1) * * *
(vii) Additional requirements prohibiting discrimination against
participants and beneficiaries based on genetic information.
* * * * *
0
6. Section 146.121 is amended by--
0
A. Revising paragraph (a)(1)(vii).
0
B. Revising paragraph (c)(2)(i).
0
C. Republishing paragraph (c)(2)(iii) (Example 1) (i).
0
D. Revising paragraph (c)(2)(iii) (Example 1) (ii).
The revisions and republication read as follows:
Sec. 146.121 Prohibiting discrimination against participants and
beneficiaries based on a health factor.
(a) * * *
(1) * * *
(vi) Genetic information, as defined in Sec. 146.122(a) of this
subchapter;
* * * * *
(c) * * *
(2) * * *
(i) Group rating based on health factors not restricted under this
section. Nothing in this section restricts the aggregate amount that an
employer may be charged for coverage under a group health plan. But see
Sec. 146.122(b) of this part, which prohibits adjustments in group
premium or contribution rates based on genetic information.
* * * * *
(iii) * * *
Example 1. (i) Facts. An employer sponsors a group health plan
and purchases coverage from a health insurance issuer. In order to
determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan.
The issuer finds that Individual F had significantly higher claims
experience than similarly situated individuals in the plan. The
issuer quotes the plan a higher per-participant rate because of F's
claims experience.
(ii) Conclusion. In this Example 1, the issuer does not violate
the provisions of this paragraph (c)(2) because the issuer blends
the rate so that the employer is not quoted a higher rate for F than
for a similarly situated individual based on F's claims experience.
(However, if the issuer used genetic information in computing the
group rate, it would violate Sec. 146.122(b) of this part.)
* * * * *
0
7. Add a new Sec. 146.122 to read as follows:
Sec. 146.122 Additional requirements prohibiting discrimination based
on genetic information.
(a) Definitions. Unless otherwise provided, the definitions in this
paragraph (a) govern in applying the provisions of this section.
(1) Collect means, with respect to information, to request,
require, or purchase such information.
(2) Family member means, with respect to an individual--
(i) A dependent (as defined in Sec. 144.103 of this part) of the
individual; or
(ii) Any other person who is a first-degree, second-degree, third-
degree, or fourth-degree relative of the individual or of a dependent
of the individual. Relatives by affinity (such as by marriage or
adoption) are treated the same as relatives by consanguinity (that is,
relatives who share a common biological ancestor). In determining the
degree of the relationship, relatives by less than full consanguinity
(such as half-siblings, who share only one parent) are treated the same
as relatives by full consanguinity (such as siblings who share both
parents).
(A) First-degree relatives include parents, spouses, siblings, and
children.
(B) Second-degree relatives include grandparents, grandchildren,
aunts, uncles, nephews, and nieces.
(C) Third-degree relatives include great-grandparents, great-
grandchildren, great aunts, great uncles, and first cousins.
(D) Fourth-degree relatives include great-great grandparents,
great-great grandchildren, and children of first cousins.
(3) Genetic information means--
(i) Subject to paragraphs (a)(3)(ii) and (iii) of this section,
with respect to an individual, information about--
(A) The individual's genetic tests (as defined in paragraph (a)(5)
of this section);
(B) The genetic tests of family members of the individual;
(C) The manifestation (as defined in paragraph (a)(6) of this
section) of a disease or disorder in family members of the individual;
or
(D) Any request for, or receipt of, genetic services (as defined in
paragraph (a)(4) of this section), or participation in clinical
research which includes genetic
[[Page 51689]]
services, by the individual or any family member of the individual.
(ii) The term genetic information does not include information
about the sex or age of any individual.
(iii) The term genetic information includes--
(A) With respect to a pregnant woman (or a family member of the
pregnant woman), genetic information of any fetus carried by the
pregnant woman; and
(B) With respect to an individual (or a family member of the
individual) who is utilizing an assisted reproductive technology,
genetic information of any embryo legally held by the individual or
family member.
(4) Genetic services means --
(i) A genetic test, as defined in paragraph (a)(5) of this section;
(ii) Genetic counseling (including obtaining, interpreting, or
assessing genetic information); or
(iii) Genetic education.
(5)(i) Genetic test means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, if the analysis detects
genotypes, mutations, or chromosomal changes. However, a genetic test
does not include an analysis of proteins or metabolites that is
directly related to a manifested disease, disorder, or pathological
condition. Accordingly, a test to determine whether an individual has a
BRCA1 or BRCA2 variant is a genetic test. Similarly, a test to
determine whether an individual has a genetic variant associated with
hereditary nonpolyposis colorectal cancer is a genetic test. However,
an HIV test, complete blood count, cholesterol test, liver function
test, or test for the presence of alcohol or drugs is not a genetic
test.
(ii) The rules of this paragraph (a)(5) are illustrated by the
following example:
Example. (i) Facts. Individual A is a newborn covered under a
group health plan. A undergoes a phenylketonuria (PKU) screening,
which measures the concentration of a metabolite, phenylalanine, in
A's blood. In PKU, a mutation occurs in the phenylalanine
hydroxylase (PAH) gene which contains instructions for making the
enzyme needed to break down the amino acid phenylalanine.
Individuals with the mutation, who have a deficiency in the enzyme
to break down phenylalanine, have high concentrations of
phenylalanine.
(ii) Conclusion. In this Example, the PKU screening is a genetic
test with respect to A because the screening is an analysis of
metabolites that detects a genetic mutation.
(6)(i) Manifestation or manifested means, with respect to a
disease, disorder, or pathological condition, that an individual has
been or could reasonably be diagnosed with the disease, disorder, or
pathological condition by a health care professional with appropriate
training and expertise in the field of medicine involved. For purposes
of this section, a disease, disorder, or pathological condition is not
manifested if a diagnosis is based principally on genetic information.
(ii) The rules of this paragraph (a)(6) are illustrated by the
following examples:
Example 1. (i) Facts. Individual A has a family medical history
of diabetes. A begins to experience excessive sweating, thirst, and
fatigue. A's physician examines A and orders blood glucose testing
(which is not a genetic test). Based on the physician's examination,
A's symptoms, and test results that show elevated levels of blood
glucose, A's physician diagnoses A as having adult onset diabetes
mellitus (Type 2 diabetes).
(ii) Conclusion. In this Example 1, A has been diagnosed by a
health care professional with appropriate training and expertise in
the field of medicine involved. The diagnosis is not based
principally on genetic information. Thus, Type 2 diabetes is
manifested with respect to A.
Example 2. (i) Facts. Individual B has several family members
with colon cancer. One of them underwent genetic testing which
detected a mutation in the MSH2 gene associated with hereditary
nonpolyposis colorectal cancer (HNPCC). B's physician, a health care
professional with appropriate training and expertise in the field of
medicine involved, recommends that B undergo a targeted genetic test
to look for the specific mutation found in B 's relative to
determine if B has an elevated risk for cancer. The genetic test
with respect to B showed that B also carries the mutation and is at
increased risk to develop colorectal and other cancers associated
with HNPCC. B has a colonoscopy which indicates no signs of disease,
and B has no symptoms.
(ii) Conclusion. In this Example 2, because B has no signs or
symptoms of colorectal cancer, B has not been and could not
reasonably be diagnosed with HNPCC. Thus, HNPCC is not manifested
with respect to B.
Example 3. (i) Facts. Same facts as Example 2, except that B's
colonoscopy and subsequent tests indicate the presence of HNPCC.
Based on the colonoscopy and subsequent test results, B's physician
makes a diagnosis of HNPCC.
(ii) Conclusion. In this Example 3, HNPCC is manifested with
respect to B because a health care professional with appropriate
training and expertise in the field of medicine involved has made a
diagnosis that is not based principally on genetic information.
Example 4. (i) Facts. Individual C has a family member that has
been diagnosed with Huntington's Disease. A genetic test indicates
that C has the Huntington's Disease gene variant. At age 42, C
begins suffering from occasional moodiness and disorientation,
symptoms which are associated with Huntington's Disease. C is
examined by a neurologist (a physician with appropriate training and
expertise for diagnosing Huntington's Disease). The examination
includes a clinical neurological exam. The results of the
examination do not support a diagnosis of Huntington's Disease.
(ii) Conclusion. In this Example 4, C is not and could not
reasonably be diagnosed with Huntington's Disease by a health care
professional with appropriate training and expertise. Therefore,
Huntington's Disease is not manifested with respect to C.
Example 5. (i) Facts. Same facts as Example 4, except that C
exhibits additional neurological and behavioral symptoms, and the
results of the examination support a diagnosis of Huntington's
Disease with respect to C.
(ii) Conclusion. In this Example 5, C could reasonably be
diagnosed with Huntington's Disease by a health care professional
with appropriate training and expertise. Therefore, Huntington's
Disease is manifested with respect to C.
(7) Underwriting purposes has the meaning given in paragraph (d)(1)
of this section.
(b) No group-based discrimination based on genetic information--(1)
In general. For purposes of this section, a group health plan, and a
health insurance issuer offering health insurance coverage in
connection with a group health plan, must not adjust premium or
contribution amounts for the plan, or any group of similarly situated
individuals under the plan, on the basis of genetic information. For
this purpose, ``similarly situated individuals'' are those described in
Sec. 146.121(d) of this part.
(2) Rule of construction. Nothing in paragraph (b)(1) of this
section (or in paragraph (d)(1) or (d)(2) of this section) limits the
ability of a health insurance issuer offering health insurance coverage
in connection with a group health plan to increase the premium for a
group health plan or a group of similarly situated individuals under
the plan based on the manifestation of a disease or disorder of an
individual who is enrolled in the plan. In such a case, however, the
manifestation of a disease or disorder in one individual cannot also be
used as genetic information about other group members to further
increase the premium for a group health plan or a group of similarly
situated individuals under the plan.
(3) Examples. The rules of this paragraph (b) are illustrated by
the following examples:
Example 1. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that three individuals covered
under the plan had unusually high claims experience. In addition,
the issuer finds that the genetic
[[Page 51690]]
information of two other individuals indicates the individuals have
a higher probability of developing certain illnesses although the
illnesses are not manifested at this time. The issuer quotes the
plan a higher per-participant rate because of both the genetic
information and the higher claims experience.
(ii) Conclusion. In this Example 1, the issuer violates the
provisions of this paragraph (b) because the issuer adjusts the
premium based on genetic information. However, if the adjustment
related solely to claims experience, the adjustment would not
violate the requirements of this section (nor would it violate the
requirements of paragraph (c) of Sec. 146.121 of this part, which
prohibits discrimination in individual premiums or contributions
based on a health factor but permits increases in the group rate
based on a health factor).
Example 2. (i) Facts. An employer sponsors a group health plan
that provides coverage through a health insurance issuer. In order
to determine the premium rate for the upcoming plan year, the issuer
reviews the claims experience of individuals covered under the plan
and other health status information of the individuals, including
genetic information. The issuer finds that Employee A has made
claims for treatment of polycystic kidney disease. A also has two
dependent children covered under the plan. The issuer quotes the
plan a higher per-participant rate because of both A's claims
experience and the family medical history of A's children (that is,
the fact that A has the disease).
(ii) Conclusion. In this Example 2, the issuer violates the
provisions of this paragraph (b) because, by taking the likelihood
that A's children may develop polycystic kidney disease into account
in computing the rate for the plan, the issuer adjusts the premium
based on genetic information relating to a condition that has not
been manifested in A's children. However, it is permissible for the
issuer to increase the premium based on A's claims experience.
(c) Limitation on requesting or requiring genetic testing--(1)
General rule. Except as otherwise provided in this paragraph (c), a
group health plan, and a health insurance issuer offering health
insurance coverage in connection with a group health plan, must not
request or require an individual or a family member of the individual
to undergo a genetic test.
(2) Health care professional may recommend a genetic test. Nothing
in paragraph (c)(1) of this section limits the authority of a health
care professional who is providing health care services to an
individual to request that the individual undergo a genetic test.
(3) Examples. The rules of paragraphs (c)(1) and (2) of this
section are illustrated by the following examples:
Example 1. (i) Facts. Individual A goes to a physician for a
routine physical examination. The physician reviews A's family
medical history and A informs the physician that A's mother has been
diagnosed with Huntington's Disease. The physician advises A that
Huntington's Disease is hereditary and recommends that A undergo a
genetic test.
(ii) Conclusion. In this Example 1, the physician is a health
care professional who is providing health care services to A.
Therefore, the physician's recommendation that A undergo the genetic
test does not violate this paragraph (c).
Example 2. (i) Facts. Individual B is covered by a health
maintenance organization (HMO). B is a child being treated for
leukemia. B's physician, who is employed by the HMO, is considering
a treatment plan that includes six-mercaptopurine, a drug for
treating leukemia in most children. However, the drug could be fatal
if taken by a small percentage of children with a particular gene
variant. B's physician recommends that B undergo a genetic test to
detect this variant before proceeding with this course of treatment.
(ii) Conclusion. In this Example 2, even though the physician is
employed by the HMO, the physician is nonetheless a health care
professional who is providing health care services to B. Therefore,
the physician's recommendation that B undergo the genetic test does
not violate this paragraph (c).
(4) Determination regarding payment.
(i) In general. As provided in this paragraph (c)(4), nothing in
paragraph (c)(1) of this section precludes a plan or issuer from
obtaining and using the results of a genetic test in making a
determination regarding payment. For this purpose, ``payment'' has the
meaning given such term in Sec. 164.501 of the privacy regulations
issued under the Health Insurance Portability and Accountability Act.
Thus, if a plan or issuer conditions payment for an item or service
based on its medical appropriateness and the medical appropriateness of
the item or service depends on the genetic makeup of a patient, then
the plan or issuer is permitted to condition payment for the item or
service on the outcome of a genetic test. The plan or issuer may also
refuse payment if the patient does not undergo the genetic test.
(ii) Limitation. A plan or issuer is permitted to request only the
minimum amount of information necessary to make a determination
regarding payment. The minimum amount of information necessary is
determined in accordance with the minimum necessary standard in Sec.
164.502(b) of the privacy regulations issued under the Health Insurance
Portability and Accountability Act.
(iii) Examples. See paragraph (e) of this section for examples
illustrating the rules of this paragraph (c)(4), as well as other
provisions of this section.
(5) Research exception. Notwithstanding paragraph (c)(1) of this
section, a plan or issuer may request, but not require, that a
participant or beneficiary undergo a genetic test if all of the
conditions of this paragraph (c)(5) are met:
(i) Research in accordance with Federal regulations and applicable
State or local law or regulations. The plan or issuer makes the request
pursuant to research, as defined in Sec. 46.102(d) of this subtitle,
that complies with part 46 of this subtitle or equivalent Federal
regulations, and any applicable State or local law or regulations for
the protection of human subjects in research.
(ii) Written request for participation in research. The plan or
issuer makes the request in writing, and the request clearly indicates
to each participant or beneficiary (or, in the case of a minor child,
to the legal guardian of the beneficiary) that -
(A) Compliance with the request is voluntary; and
(B) Noncompliance will have no effect on eligibility for benefits
(as described in Sec. 146.121(b)(1) of this part) or premium or
contribution amounts.
(iii) Prohibition on underwriting. No genetic information collected
or acquired under this paragraph (c)(5) can be used for underwriting
purposes (as described in paragraph (d)(1) of this section).
(iv) Notice to Federal agencies. The plan or issuer completes a
copy of the ``Notice of Research Exception under the Genetic
Information Nondiscrimination Act'' authorized by the Secretary and
provides the notice to the address specified in the instructions
thereto.
(d) Prohibitions on collection of genetic information.
(1) For underwriting purposes.
(i) General rule. A group health plan, and a health insurance
issuer offering health insurance coverage in connection with a group
health plan, must not collect (as defined in paragraph (a)(1) of this
section) genetic information for underwriting purposes. See paragraph
(e) of this section for examples illustrating the rules of this
paragraph (d)(1), as well as other provisions of this section.
(ii) Underwriting purposes defined. Subject to paragraph
(d)(1)(iii) of this section, underwriting purposes means, with respect
to any group health plan, or health insurance coverage offered in
connection with a group health plan--
(A) Rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the plan or
coverage as described in Sec. 146.121(b)(1)(ii) of this part
(including changes in deductibles or other cost-
[[Page 51691]]
sharing mechanisms in return for activities such as completing a health
risk assessment or participating in a wellness program);
(B) The computation of premium or contribution amounts under the
plan or coverage (including discounts, rebates, payments in kind, or
other premium differential mechanisms in return for activities such as
completing a health risk assessment or participating in a wellness
program);
(C) The application of any preexisting condition exclusion under
the plan or coverage; and
(D) Other activities related to the creation, renewal, or
replacement of a contract of health insurance or health benefits.
(iii) Medical appropriateness. If an individual seeks a benefit
under a group health plan or health insurance coverage, the plan or
coverage may limit or exclude the benefit based on whether the benefit
is medically appropriate, and the determination of whether the benefit
is medically appropriate is not within the meaning of underwriting
purposes. Accordingly, if an individual seeks a benefit under the plan
and the plan or issuer conditions the benefit based on its medical
appropriateness and the medical appropriateness of the benefit depends
on genetic information of the individual, then the plan or issuer is
permitted to condition the benefit on the genetic information. A plan
or issuer is permitted to request only the minimum amount of genetic
information necessary to determine medical appropriateness. The plan or
issuer may deny the benefit if the patient does not provide the genetic
information required to determine medical appropriateness. If an
individual is not seeking a benefit, the medical appropriateness
exception of this paragraph (d)(1)(iii) to the definition of
underwriting purposes does not apply. See paragraph (e) of this section
for examples illustrating the medical appropriateness provisions of
this paragraph (d)(1)(iii), as well as other provisions of this
section.
(2) Prior to or in connection with enrollment. (i) In general. A
group health plan, and a health insurance issuer offering health
insurance coverage in connection with a group health plan, must not
collect genetic information with respect to any individual prior to
that individual's effective date of coverage under that plan or
coverage, nor in connection with the rules for eligibility (as defined
in Sec. 146.121(b)(1)(ii) of this part) that apply to that individual.
Whether or not an individual's information is collected prior to that
individual's effective date of coverage is determined at the time of
collection.
(ii) Incidental collection exception.
(A) In general. If a group health plan, or a health insurance
issuer offering health insurance coverage in connection with a group
health plan, obtains genetic information incidental to the collection
of other information concerning any individual, the collection is not a
violation of this paragraph (d)(2), as long as the collection is not
for underwriting purposes in violation of paragraph (d)(1) of this
section.
(B) Limitation. The incidental collection exception of this
paragraph (d)(2)(ii) does not apply in connection with any collection
where it is reasonable to anticipate that health information will be
received, unless the collection explicitly states that genetic
information should not be provided.
(3) Examples. The rules of this paragraph (d) are illustrated by
the following examples:
Example 1. (i) Facts. A group health plan provides a premium
reduction to enrollees who complete a health risk assessment. The
health risk assessment is requested to be completed after
enrollment. Whether or not it is completed or what responses are
given on it has no effect on an individual's enrollment status, or
on the enrollment status of members of the individual's family. The
health risk assessment includes questions about the individual's
family medical history.
(ii) Conclusion. In this Example 1, the health risk assessment
includes a request for genetic information (that is, the
individual's family medical history). Because completing the health
risk assessment results in a premium reduction, the request for
genetic information is for underwriting purposes. Consequently, the
request violates the prohibition on the collection of genetic
information in paragraph (d)(1) of this section.
Example 2. (i) Facts. The same facts as Example 1, except there
is no premium reduction or any other reward for completing the
health risk assessment.
(ii) Conclusion. In this Example 2, the request is not for
underwriting purposes, nor is it prior to or in connection with
enrollment. Therefore, it does not violate the prohibition on the
collection of genetic information in this paragraph (d).
Example 3. (i) Facts. A group health plan requests that
enrollees complete a health risk assessment prior to enrollment, and
includes questions about the individual's family medical history.
There is no reward or penalty for completing the health risk
assessment.
(ii) Conclusion. In this Example 3, because the health risk
assessment includes a request for genetic information (that is, the
individual's family medical history), and requests the information
prior to enrollment, the request violates the prohibition on the
collection of genetic information in paragraph (d)(2) of this
section. Moreover, because it is a request for genetic information,
it is not an incidental collection under paragraph (d)(2)(ii) of
this section.
Example 4. (i) Facts. The facts are the same as in Example 1,
except there is no premium reduction or any other reward given for
completion of the health risk assessment. However, certain people
completing the health risk assessment may become eligible for
additional benefits under the plan by being enrolled in a disease
management program based on their answers to questions about family
medical history. Other people may become eligible for the disease
management program based solely on their answers to questions about
their individual medical history.
(ii) Conclusion. In this Example 4, the request for information
about an individual's family medical history could result in the
individual being eligible for benefits for which the individual
would not otherwise be eligible. Therefore, the questions about
family medical history on the health risk assessment are a request
for genetic information for underwriting purposes and are prohibited
under this paragraph (d). Although the plan conditions eligibility
for the disease management program based on determinations of
medical appropriateness, the exception for determinations of medical
appropriateness does not apply because the individual is not seeking
benefits.
Example 5. (i) Facts. A group health plan requests enrollees to
complete two distinct health risk assessments (HRAs) after and
unrelated to enrollment. The first HRA instructs the individual to
answer only for the individual and not for the individual's family.
The first HRA does not ask about any genetic tests the individual
has undergone or any genetic services the individual has received.
The plan offers a reward for completing the first HRA. The second
HRA asks about family medical history and the results of genetic
tests the individual has undergone. The plan offers no reward for
completing the second HRA and the instructions make clear that
completion of the second HRA is wholly voluntary and will not affect
the reward given for completion of the first HRA.
(ii) Conclusion. In this Example 5, no genetic information is
collected in connection with the first HRA, which offers a reward,
and no benefits or other rewards are conditioned on the request for
genetic information in the second HRA. Consequently, the request for
genetic information in the second HRA is not for underwriting
purposes, and the two HRAs do not violate the prohibition on the
collection of genetic information in this paragraph (d).
Example 6. (i) Facts. A group health plan waives its annual
deductible for enrollees who complete an HRA. The HRA is requested
to be completed after enrollment. Whether or not the HRA is
completed or what responses are given on it has no effect on an
individual's enrollment status, or on the enrollment status of
members of the individual's family. The HRA does not include any
direct questions about the individual's genetic information
(including family medical history). However, the last
[[Page 51692]]
question reads, ``Is there anything else relevant to your health
that you would like us to know or discuss with you?''
(ii) Conclusion. In this Example 6, the plan's request for
medical information does not explicitly state that genetic
information should not be provided. Therefore, any genetic
information collected in response to the question is not within the
incidental collection exception and is prohibited under this
paragraph (d).
Example 7. (i) Facts. Same facts as Example 6, except that the
last question goes on to state, ``In answering this question, you
should not include any genetic information. That is, please do not
include any family medical history or any information related to
genetic testing, genetic services, genetic counseling, or genetic
diseases for which you believe you may be at risk.''
(ii) Conclusion. In this Example 7, the plan's request for
medical information explicitly states that genetic information
should not be provided. Therefore, any genetic information collected
in response to the question is within the incidental collection
exception. However, the plan may not use any genetic information it
obtains incidentally for underwriting purposes.
Example 8. (i) Facts. Issuer M acquires Issuer N. M requests N's
records, stating that N should not provide genetic information and
should review the records to excise any genetic information. N
assembles the data requested by M and, although N reviews it to
delete genetic information, the data from a specific region included
some individuals' family medical history. Consequently, M receives
genetic information about some of N's covered individuals.
(ii) Conclusion. In this Example 8, M's request for health
information explicitly stated that genetic information should not be
provided. Therefore, the collection of genetic information was
within the incidental collection exception. However, M may not use
the genetic information it obtained incidentally for underwriting
purposes.
(e) Examples regarding determinations of medical appropriateness.
The application of the rules of paragraphs (c) and (d) of this section
to plan or issuer determinations of medical appropriateness is
illustrated by the following examples:
Example 1. (i) Facts. Individual A group health plan covers
genetic testing for celiac disease for individuals who have family
members with this condition. After A's son is diagnosed with celiac
disease, A undergoes a genetic test and promptly submits a claim for
the test to A's issuer for reimbursement. The issuer asks A to
provide the results of the genetic test before the claim is paid.
(ii) Conclusion. In this Example 1, under the rules of paragraph
(c)(4) of this section the issuer is permitted to request only the
minimum amount of information necessary to make a decision regarding
payment. Because the results of the test are not necessary for the
issuer to make a decision regarding the payment of A's claim, the
issuer's request for the results of the genetic test violates
paragraph (c) of this section.
Example 2. (i) Facts. Individual B's group health plan covers a
yearly mammogram for participants and beneficiaries starting at age
40, or at age 30 for those with increased risk for breast cancer,
including individuals with BRCA1 or BRCA2 gene mutations. B is 33
years old and has the BRCA2 mutation. B undergoes a mammogram and
promptly submits a claim to B's plan for reimbursement. Following an
established policy, the plan asks B for evidence of increased risk
of breast cancer, such as the results of a genetic test or a family
history of breast cancer, before the claim for the mammogram is
paid. This policy is applied uniformly to all similarly situated
individuals and is not directed at individuals based on any genetic
information.
(ii) Conclusion. In this Example 2, the plan does not violate
paragraphs (c) or (d) of this section. Under paragraph (c), the plan
is permitted to request and use the results of a genetic test to
make a determination regarding payment, provided the plan requests
only the minimum amount of information necessary. Because the
medical appropriateness of the mammogram depends on the genetic
makeup of the patient, the minimum amount of information necessary
includes the results of the genetic test. Similarly, the plan does
not violate paragraph (d) of this section because the plan is
permitted to request genetic information in making a determination
regarding the medical appropriateness of a claim if the genetic
information is necessary to make the determination (and if the
genetic information is not used for underwriting purposes).
Example 3. (i) Facts. Individual C was previously diagnosed with
and treated for breast cancer, which is currently in remission. In
accordance with the recommendation of C's physician, C has been
taking a regular dose of tamoxifen to help prevent a recurrence. C's
group health plan adopts a new policy requiring patients taking
tamoxifen to undergo a genetic test to ensure that tamoxifen is
medically appropriate for their genetic makeup. In accordance with,
at the time, the latest scientific research, tamoxifen is not
helpful in up to 7 percent of breast cancer patients, those with
certain variations of the gene for making the CYP2D6
enzyme. If a patient has a gene variant making tamoxifen not
medically appropriate, the plan does not pay for the tamoxifen
prescription.
(ii) Conclusion. In this Example 3, the plan does not violate
paragraph (c) of this section if it conditions future payments for
the tamoxifen prescription on C's undergoing a genetic test to
determine what genetic markers C has for making the
CYP2D6 enzyme. Nor does the plan violate paragraph (c) of
this section if the plan refuses future payment if the results of
the genetic test indicate that tamoxifen is not medically
appropriate for C.
Example 4. (i) Facts. A group health plan offers a diabetes
disease management program to all similarly situated individuals for
whom it is medically appropriate based on whether the individuals
have or are at risk for diabetes. The program provides enhanced
benefits related only to diabetes for individuals who qualify for
the program. The plan sends out a notice to all participants that
describes the diabetes disease management program and explains the
terms for eligibility. Individuals interested in enrolling in the
program are advised to contact the plan to demonstrate that they
have diabetes or that they are at risk for diabetes. For individuals
who do not currently have diabetes, genetic information may be used
to demonstrate that an individual is at risk.
(ii) Conclusion. In this Example 4, the plan may condition
benefits under the disease management program upon a showing by an
individual that the individual is at risk for diabetes, even if such
showing may involve genetic information, provided that the plan
requests genetic information only when necessary to make a
determination regarding whether the disease management program is
medically appropriate for the individual and only requests the
minimum amount of information necessary to make that determination.
Example 5. (i) Facts. Same facts as Example 4, except that the
plan includes a questionnaire that asks about the occurrence of
diabetes in members of the individual's family as part of the notice
describing the disease management program.
(ii) Conclusion. In this Example 5, the plan violates the
requirements of paragraph (d)(1) of this section because the
requests for genetic information are not limited to those situations
in which it is necessary to make a determination regarding whether
the disease management program is medically appropriate for the
individuals.
Example 6. (i) Facts. Same facts as Example 4, except the
disease management program provides an enhanced benefit in the form
of a lower annual deductible to individuals under the program; the
lower deductible applies with respect to all medical expenses
incurred by the individual. Thus, whether or not a claim relates to
diabetes, the individual is provided with a lower deductible based
on the individual providing the plan with genetic information.
(ii) Conclusion. In this Example 6, because the enhanced
benefits include benefits not related to the determination of
medical appropriateness, making available the enhanced benefits is
within the meaning of underwriting purposes. Accordingly, the plan
may not request or require genetic information (including family
history information) in determining eligibility for enhanced
benefits under the program because such a request would be for
underwriting purposes and would violate paragraph (d)(1) of this
section.
(f) Applicability date. This section applies for plan years
beginning on or after December 7, 2009.
0
8. Section 146.145 is amended by revising paragraph (b) as follows:
Sec. 146.145 Special rules relating to group health plans.
* * * * *
(b) General exception for certain small group health plans. The
requirements of this part, other than Sec. 146.130 and the provisions
with respect to genetic
[[Page 51693]]
nondiscrimination (found in Sec. 146.111(b)(6), Sec. 146.121(b),
Sec. 146.121(c), Sec. 146.121(e), Sec. 146.122(b), Sec. 146.122(c),
Sec. 146.122(d), and Sec. 146.122(e)) do not apply to any group
health plan (and group health insurance coverage) for any plan year, if
on the first day of the plan year, the plan has fewer than two
participants who are current employees.
* * * * *
0
9. Section 146.180 is amended by--
0
A. Revising paragraph (a)(1)(iii).
0
B. Revising paragraph (h).
0
C. In paragraph (i), removing the reference ``(h)'' and added the
reference ``(h)(1)'' in its place each time it appears.
0
D. Revising the last sentence of paragraph (k).
The revisions read as follows:
Sec. 146.180 Treatment of non-Federal governmental plans.
(a) * * *
(1) * * *
(iii) Prohibitions against discriminating against individual
participants and beneficiaries based on health status described in
Sec. 146.121, except that the sponsor of a self-funded non-Federal
governmental plan cannot elect to exempt its plan from the requirements
in Sec. 146.121(a)(1)(vi) and Sec. 146.122 that prohibit
discrimination with respect to genetic information.
* * * * *
(h) Requirements not subject to exemption.
(1) Certification and disclosure of creditable coverage. Without
regard to an election under this section, a non-Federal governmental
plan must provide for certification and disclosure of creditable
coverage under the plan with respect to participants and their
dependents as specified under Sec. 146.115 of this part.
(2) Genetic information. Without regard to an election under this
section that exempts a non-Federal governmental plan from any or all of
the provisions of Sec. 146.111 and Sec. 146.121 of this part, the
exemption election must not be construed to exempt the plan from any
provisions of this part 146 that pertain to genetic information.
(3) Enforcement. CMS enforces these requirements as provided under
paragraph (k) of this section.
(4) Examples.
(i)
Example 1. (A) Individual A is hired by a county that has
elected to exempt its self-funded group health plan from certain
requirements of paragraph (a)(1) of this section, including
prohibitions against enrollment discrimination based on health
status-related factors. Individual A applies for enrollment in the
county's group health plan. Applicants must pass medical
underwriting before being allowed to enroll in the plan. The plan
requires an applicant to complete a medical history form and to
authorize the plan to contact physicians regarding any medical
treatments the applicant has received in the past 5 years.
Individual A has Type 2 diabetes. He submits the required form,
which reflects that condition. The plan also receives information
from Individual A's physicians. While the plan's request to
Individual A's physicians did not include a request for genetic
information, the plan received information from a physician in
response to its request for health information about Individual A,
that one of Individual A's parents has Huntington's Disease. The
Plan denies enrollment to Individual A.
(B) Individual A files a complaint with CMS that he has been
denied enrollment in the plan because of genetic information the
plan received. CMS investigates the complaint and determines that
the plan uniformly denies enrollment to anyone who has Type II
diabetes. CMS resolves the complaint in favor of the plan on the
basis that the plan permissibly denied enrollment to Individual A
under its exemption election because of the existence of a medical
condition that uniformly disqualifies individuals from participating
in the plan.
(ii)
Example 2. (A) Same facts as in Example 1, except Individual A
does not have diabetes or any other preexisting medical condition;
that is, there is no manifestation of a disease or disorder with
respect to Individual A at the time of his application for
enrollment in the county's group health plan.
(B) In these circumstances, CMS resolves the complaint in favor
of Individual A because CMS determines that the plan impermissibly
denied enrollment to Individual A on the basis of genetic
information. CMS instructs the plan to permit Individual A to enroll
in the plan retroactive to the earliest date coverage would be
effective under the terms of the plan based on the date of
Individual A's enrollment application or hire, as applicable. CMS
may impose a civil money penalty, as determined under subpart C of
part 150.
* * * * *
(k) * * *. This may include imposing a civil money penalty against
the plan or plan sponsor, as determined under subpart C of part 150.
* * * * *
PART 148--REQUIREMENTS FOR THE INDIVIDUAL HEALTH INSURANCE MARKET
0
10. The authority citation for part 148 continues to read as follows:
Authority: Secs. 2741 through 2763, 2791, and 2792 of the Public
Health Service Act, 42 U.S.C. 300gg-41 through 300gg-63, 300gg-91,
and 300gg-92.
0
11. Section 148.101 is amended by revising the last sentence to read as
follows:
Sec. 148.101 Basis and purpose.
* * *. It also provides certain protections for mothers and
newborns with respect to coverage for hospital stays in connection with
childbirth and protects all individuals and family members who have, or
seek, individual health insurance coverage from discrimination based on
genetic information.
0
12. Section 148.102 is amended by revising the last sentence of
paragraph (a)(2) and paragraph (b) to read as follows:
Sec. 148.102 Scope, applicability, and effective dates.
(a) * * *
(2) * * *. The requirements that pertain to guaranteed renewability
for all individuals, to protections for mothers and newborns with
respect to hospital stays in connection with childbirth, and to
protections against discrimination based on genetic information apply
to all issuers of individual health insurance coverage in the State,
regardless of whether a State implements an alternative mechanism under
Sec. 148.128 of this part.
(b) Effective date. Except as provided in Sec. 148.124
(certificate of creditable coverage), Sec. 148.128 (alternative State
mechanisms), Sec. 148.170 (standards relating to benefits for mothers
and newborns), and Sec. 148.180 (prohibition of health discrimination
based on genetic information) of this part, the requirements of this
part apply to health insurance coverage offered, sold, issued, renewed,
in effect, or operated in the individual market after June 30, 1997,
regardless of when a period of creditable coverage occurs.
Sec. 148.120 [Amended]
0
13. Section 148.120 is amended by--
0
A. In paragraphs (c)(5)(ii), (d)(2), and (e)(2) removing the cross-
reference ``Sec. 148.200'' and adding in its place the cross-reference
``part 150'' each time it appears.
0
B. In paragraph (f)(1) removing the term ``If'' and adding in its place
the phrase ``Except as prohibited by Sec. 148.180, if''.
0
C. In paragraph (g)(4) removing the term ``This'' and adding in its
place the phrase ``Except as prohibited by Sec. 148.180, this''.
0
14. A new Sec. 148.180 is added to subpart C to read as follows:
[[Page 51694]]
Sec. 148.180 Prohibition of discrimination based on genetic
information.
(a) Definitions. For purposes of this section, the following
definitions as set forth in Sec. 146.122 of this subchapter pertain to
health insurance issuers in the individual market to the extent that
those definitions are not inconsistent with respect to health insurance
coverage offered, sold, issued, renewed, in effect or operated in the
individual market:
Collect has the meaning set forth at Sec. 146.122(a).
Family member has the meaning set forth at Sec. 146.122(a).
Genetic information has the meaning set forth at Sec. 146.122(a).
Genetic services has the meaning set forth at Sec. 146.122(a).
Genetic test has the meaning set forth at Sec. 146.122(a).
Manifestation or manifested has the meaning set forth at Sec.
146.122(a).
Preexisting condition exclusion has the meaning set forth at Sec.
144.103.
Underwriting purposes has the meaning set forth at Sec.
148.180(f)(1).
(b) Prohibition on genetic information as a condition of
eligibility.
(1) In general. An issuer offering health insurance coverage in the
individual market may not establish rules for the eligibility
(including continued eligibility) of any individual to enroll in
individual health insurance coverage based on genetic information.
(2) Rule of construction. Nothing in paragraph (b)(1) of this
section precludes an issuer from establishing rules for eligibility for
an individual to enroll in individual health insurance coverage based
on the manifestation of a disease or disorder in that individual, or in
a family member of that individual when the family member is covered
under the policy that covers the individual.
(3) Examples. The rules of this paragraph (b) are illustrated by
the following examples:
Example 1. (i) Facts. A State implements the HIPAA guaranteed
availability requirement in the individual health insurance market
in accordance with Sec. 148.120. Individual A and his spouse S are
not ``eligible individuals'' as that term is defined at Sec.
148.103 and, therefore, they are not entitled to obtain individual
health insurance coverage on a guaranteed available basis. They
apply for individual coverage with Issuer M. As part of the
application for coverage, M receives health information about A and
S. Although A has no known medical conditions, S has high blood
pressure. M declines to offer coverage to S.
(ii) Conclusion. In this Example 1, M permissibly may decline to
offer coverage to S because S has a manifested disorder (high blood
pressure) that makes her ineligible for coverage under the policy's
rules for eligibility.
Example 2. (i) Facts. Same facts as Example 1, except that S
does not have high blood pressure or any other known medical
condition. The only health information relevant to S that M receives
in the application indicates that both of S's parents are overweight
and have high blood pressure. M declines to offer coverage to S.
(ii) Conclusion. In this Example 2, M cannot decline to offer
coverage to S because S does not have a manifested disease or
disorder. The only health information M has that relates to her
pertains to a manifested disease or disorder of family members,
which as family medical history constitutes genetic information with
respect to S. If M denies eligibility to S based on genetic
information, the denial will violate this paragraph (b).
(c) Prohibition on genetic information in setting premium rates.
(1) In general. An issuer offering health insurance coverage in the
individual market must not adjust premium amounts for an individual on
the basis of genetic information regarding the individual or a family
member of the individual.
(2) Rule of construction. (i) Nothing in paragraph (c)(1) of this
section precludes an issuer from adjusting premium amounts for an
individual on the basis of a manifestation of a disease or disorder in
that individual, or on the basis of a manifestation of a disease or
disorder in a family member of that individual when the family member
is covered under the policy that covers the individual.
(ii) The manifestation of a disease or disorder in one individual
cannot also be used as genetic information about other individuals
covered under the policy issued to that individual and to further
increase premium amounts.
(3) Examples. The rules of this paragraph (c) are illustrated by
the following examples:
Example 1. (i) Facts. Individual B is covered under an
individual health insurance policy through Issuer N. Every other
policy year, before renewal, N requires policyholders to submit
updated health information before the policy renewal date for
purposes of determining an appropriate premium, in excess of any
increases due to inflation, based on the policyholders' health
status. B complies with that requirement. During the past year, B's
blood glucose levels have increased significantly. N increases its
premium for renewing B's policy to account for N's increased risk
associated with B's elevated blood glucose levels.
(ii) Conclusion. In this Example 1, N is permitted to increase
the premium for B's policy on the basis of a manifested disorder
(elevated blood glucose) in B.
Example 2. (i) Facts. Same facts as Example 1, except that B's
blood glucose levels have not increased and are well within the
normal range. In providing updated health information to N, B
indicates that both his mother and sister are being treated for
adult onset diabetes mellitus (Type 2 diabetes). B provides this
information voluntarily and not in response to a specific request
for family medical history or other genetic information. N increases
B's premium to account for B's genetic predisposition to develop
Type 2 diabetes in the future.
(ii) Conclusion. In this Example 2, N cannot increase B's
premium on the basis of B's family medical history of Type 2
diabetes, which is genetic information with respect to B. Since
there is no manifestation of the disease in B at this point in time,
N cannot increase B's premium.
(d) Prohibition on genetic information as preexisting condition.
(1) In general. An issuer offering health insurance coverage in the
individual market may not, on the basis of genetic information, impose
any preexisting condition exclusion with respect to that coverage.
(2) Rule of construction. Nothing in paragraph (d)(1) of this
section precludes an issuer from imposing any preexisting condition
exclusion for an individual with respect to health insurance coverage
on the basis of a manifestation of a disease or disorder in that
individual.
(3) Examples: The rules of this paragraph (d) are illustrated by
the following examples:
Example 1. (i) Facts. Individual C has encountered delays in
receiving payment from the issuer of his individual health insurance
policy for covered services. He decides to switch carriers and
applies for an individual health insurance policy through Issuer O.
C is generally in good health, but has arthritis for which he has
received medical treatment. O offers C an individual policy that
excludes coverage for a 12-month period for any services related to
C's arthritis.
(ii) Conclusion. In this Example 1, O is permitted to impose a
preexisting condition exclusion with respect to C because C has a
manifested disease (arthritis).
Example 2. (i) Facts. Individual D applies for individual health
insurance coverage through Issuer P. D has no known medical
conditions. However, in response to P's request for medical
information about D, P receives information from D's physician that
indicates that both of D's parents have adult onset diabetes
mellitus (Type 2 diabetes). P offers D an individual policy with a
rider that permanently excludes coverage for any treatment related
to diabetes that D may receive while covered by the policy, based on
the fact that both of D's parents have the disease.
(ii) Conclusion. In this Example 2, the rider violates this
paragraph (d) because the preexisting condition exclusion is based
on genetic information with respect to D (family medical history of
Type 2 diabetes).
(e) Limitation on requesting or requiring genetic testing.
(1) General rule. Except as otherwise provided in this paragraph
(e), an issuer
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offering health insurance coverage in the individual market must not
request or require an individual or a family member of the individual
to undergo a genetic test.
(2) Health care professional may recommend a genetic test. Nothing
in paragraph (e)(1) of this section limits the authority of a health
care professional who is providing health care services to an
individual to request that the individual undergo a genetic test.
(3) Examples. The rules of paragraphs (e)(1) and (e)(2) of this
section are illustrated by the following examples:
Example 1. (i) Facts. Individual E goes to a physician for a
routine physical examination. The physician reviews E's family
medical history, and E informs the physician that E's mother has
been diagnosed with Huntington's Disease. The physician advises E
that Huntington's Disease is hereditary, and recommends that E
undergo a genetic test.
(ii) Conclusion. In this Example 1, the physician is a health
care professional who is providing health care services to E.
Therefore, the physician's recommendation that E undergo the genetic
test does not violate this paragraph (e).
Example 2. (i) Facts. Individual F is covered by a health
maintenance organization (HMO). F is a child being treated for
leukemia. F's physician, who is employed by the HMO, is considering
a treatment plan that includes six-mercaptopurine, a drug for
treating leukemia in most children. However, the drug could be fatal
if taken by a small percentage of children with a particular gene
variant. F's physician recommends that F undergo a genetic test to
detect this variant before proceeding with this course of treatment.
(ii) Conclusion. In this Example 2, even though the physician is
employed by the HMO, the physician is nonetheless a health care
professional who is providing health care services to F. Therefore,
the physician's recommendation that F undergo the genetic test does
not violate this paragraph (e).
(4) Determination regarding payment. (i) In general. As provided in
this paragraph (e)(4), nothing in paragraph (e)(1) of this section
precludes an issuer offering health insurance in the individual market
from obtaining and using the results of a genetic test in making a
determination regarding payment. For this purpose, ``payment'' has the
meaning given such term in Sec. 164.501 of this subtitle of the
privacy regulations issued under the Health Insurance Portability and
Accountability Act. Thus, if an issuer conditions payment for an item
or service based on its medical appropriateness and the medical
appropriateness of the item or service depends on a covered
individual's genetic makeup, the issuer is permitted to condition
payment on the outcome of a genetic test, and may refuse payment if the
covered individual does not undergo the genetic test.
(ii) Limitation. An issuer in the individual market is permitted to
request only the minimum amount of information necessary to make a
determination regarding payment. The minimum amount of information
necessary is determined in accordance with the minimum necessary
standard in Sec. 164.502(b) of this subtitle of the privacy
regulations issued under the Health Insurance Portability and
Accountability Act.
(iii) Examples. See paragraph (g) of this section for examples
illustrating the rules of this paragraph (e)(4), as well as other
provisions of this section.
(5) Research exception. Notwithstanding paragraph (e)(1) of this
section, an issuer may request, but not require, that an individual or
family member covered under the same policy undergo a genetic test if
all of the conditions of this paragraph (e)(5) are met:
(i) Research in accordance with Federal regulations and applicable
State or local law or regulations. The issuer makes the request
pursuant to research, as defined in Sec. 46.102(d) of this subtitle,
that complies with Part 46 of this subtitle or equivalent Federal
regulations, and any applicable State or local law or regulations for
the protection of human subjects in research.
(ii) Written request for participation in research. The issuer
makes the request in writing, and the request clearly indicates to each
individual (or, in the case of a minor child, to the child's legal
guardian) that--
(A) Compliance with the request is voluntary; and
(B) Noncompliance will have no effect on eligibility for benefits
(as described in paragraph (b) of this section) or premium amounts (as
described in paragraph (c) of this section).
(iii) Prohibition on underwriting. No genetic information collected
or acquired under this paragraph (e)(5) can be used for underwriting
purposes (as described in paragraph (f)(1) of this section).
(iv) Notice to Federal agencies. The issuer completes a copy of the
``Notice of Research Exception under the Genetic Information
Nondiscrimination Act'' authorized by the Secretary and provides the
notice to the address specified in the instructions thereto.
(f) Prohibitions on collection of genetic information.
(1) For underwriting purposes.
(i) General rule. An issuer offering health insurance coverage in
the individual market must not collect (as defined in paragraph (a) of
this section) genetic information for underwriting purposes. See
paragraph (g) of this section for examples illustrating the rules of
this paragraph (f)(1), as well as other provisions of this section.
(ii) Underwriting purposes defined. Subject to paragraph
(f)(1)(iii) of this section, underwriting purposes means, with respect
to any issuer offering health insurance coverage in the individual
market--
(A) Rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the coverage;
(B) The computation of premium amounts under the coverage;
(C) The application of any preexisting condition exclusion under
the coverage; and
(D) Other activities related to the creation, renewal, or
replacement of a contract of health insurance.
(iii) Medical appropriateness. An issuer in the individual market
may limit or exclude a benefit based on whether the benefit is
medically appropriate, and the determination of whether the benefit is
medically appropriate is not within the meaning of underwriting
purposes. Accordingly, if an issuer conditions a benefit based on its
medical appropriateness and the medical appropriateness of the benefit
depends on a covered individual's genetic information, the issuer is
permitted to condition the benefit on the genetic information. An
issuer is permitted to request only the minimum amount of genetic
information necessary to determine medical appropriateness, and may
deny the benefit if the covered individual does not provide the genetic
information required to determine medical appropriateness. See
paragraph (g) of this section for examples illustrating the
applicability of this paragraph (f)(1)(iii), as well as other
provisions of this section.
(2) Prior to or in connection with enrollment.
(i) In general. An issuer offering health insurance coverage in the
individual market must not collect genetic information with respect to
any individual prior to that individual's enrollment under the coverage
or in connection with that individual's enrollment. Whether or not an
individual's information is collected prior to that individual's
enrollment is determined at the time of collection.
(ii) Incidental collection exception.
(A) In general. If an issuer offering health insurance coverage in
the individual market obtains genetic information incidental to the
collection
[[Page 51696]]
of other information concerning any individual, the collection is not a
violation of this paragraph (f)(2), as long as the collection is not
for underwriting purposes in violation of paragraph (f)(1) of this
section.
(B) Limitation. The incidental collection exception of this
paragraph (f)(2)(ii) does not apply in connection with any collection
where it is reasonable to anticipate that health information will be
received, unless the collection explicitly provides that genetic
information should not be provided.
(iii) Examples. The rules of this paragraph (f)(2) are illustrated
by the following examples:
Example 1. (i) Facts. Individual G applies for a health
insurance policy through Issuer Q. Q's application materials ask for
the applicant's medical history, but not for family medical history.
The application's instructions state that no genetic information,
including family medical history, should be provided. G answers the
questions in the application completely and truthfully, but
volunteers certain health information about diseases his parents
had, believing that Q also needs this information.
(ii) Conclusion. In this Example 1, G's family medical history
is genetic information with respect to G. However, since Q did not
request this genetic information, and Q's instructions stated that
no genetic information should be provided, Q's collection is an
incidental collection under paragraph (f)(2)(ii). However, Q may not
use the genetic information it obtained incidentally for
underwriting purposes.
Example 2. (i) Facts. Individual H applies for a health
insurance policy through Issuer R. R's application materials request
that an applicant provide information on his or her individual
medical history, including the names and contact information of
physicians from whom the applicant sought treatment. The application
includes a release which authorizes the physicians to furnish
information to R. R forwards a request for health information about
H, including the signed release, to his primary care physician.
Although the request for information does not ask for genetic
information, including family medical history, it does not state
that no genetic information should be provided. The physician's
office administrator includes part of H's family medical history in
the package to R.
(ii) Conclusion. In this Example 2, R's request was for health
information solely about its applicant, H, which is not genetic
information with respect to H. However, R's materials did not state
that genetic information should not be provided. Therefore, R's
collection of H's family medical history (which is genetic
information with respect to H), violates the rule against collection
of genetic information and does not qualify for the incidental
collection exception under paragraph (f)(2)(ii).
Example 3. (i) Facts. Issuer S acquires Issuer T. S requests T's
records, stating that S should not provide genetic information and
should review the records to excise any genetic information. T
assembles the data requested by S and, although T reviews it to
delete genetic information, the data from a specific region included
some individuals' family medical history. Consequently, S receives
genetic information about some of T's covered individuals.
(ii) Conclusion. In this Example 3, S's request for health
information explicitly stated that genetic information should not be
provided. Therefore, its collection of genetic information was
within the incidental collection exception. However, S may not use
the genetic information it obtained incidentally for underwriting
purposes.
(g) Examples regarding determinations of medical appropriateness.
The application of the rules of paragraphs (e) and (f) of this section
to issuer determinations of medical appropriateness is illustrated by
the following examples:
Example 1. (i) Facts. Individual I has an individual health
insurance policy through Issuer U that covers genetic testing for
celiac disease for individuals who have family members with this
condition. I's policy includes dependent coverage. After I's son is
diagnosed with celiac disease, I undergoes a genetic test and
promptly submits a claim for the test to U for reimbursement. U asks
I to provide the results of the genetic test before the claim is
paid.
(ii) Conclusion. In this Example 1, under the rules of paragraph
(e)(4) of this section, U is permitted to request only the minimum
amount of information necessary to make a decision regarding
payment. Because the results of the test are not necessary for U to
make a decision regarding the payment of I's claim, U's request for
the results of the genetic test violates paragraph (e) of this
section.
Example 2. (i) Facts. Individual J has an individual health
insurance policy through Issuer V that covers a yearly mammogram for
participants starting at age 40, or at age 30 for those with
increased risk for breast cancer, including individuals with BRCA1
or BRCA2 gene mutations. J is 33 years old and has the BRCA2
mutation. J undergoes a mammogram and promptly submits a claim to V
for reimbursement. V asks J for evidence of increased risk of breast
cancer, such as the results of a genetic test, before the claim for
the mammogram is paid.
(ii) Conclusion. In this Example 2, V does not violate
paragraphs (e) or (f) of this section. Under paragraph (e), an
issuer is permitted to request and use the results of a genetic test
to make a determination regarding payment, provided the issuer
requests only the minimum amount of information necessary. Because
the medical appropriateness of the mammogram depends on the covered
individual's genetic makeup, the minimum amount of information
necessary includes the results of the genetic test. Similarly, V
does not violate paragraph (f) of this section because an issuer is
permitted to request genetic information in making a determination
regarding the medical appropriateness of a claim if the genetic
information is necessary to make the determination (and the genetic
information is not used for underwriting purposes).
Example 3. (i) Facts. Individual K was previously diagnosed with
and treated for breast cancer, which is currently in remission. In
accordance with the recommendation of K's physician, K has been
taking a regular dose of tamoxifen to help prevent a recurrence. K
has an individual health insurance policy through Issuer W which
adopts a new policy requiring patients taking tamoxifen to undergo a
genetic test to ensure that tamoxifen is medically appropriate for
their genetic makeup. In accordance with, at the time, the latest
scientific research, tamoxifen is not helpful in up to 7 percent of
breast cancer patients with certain variations of the gene for
making the CYP2D6 enzyme. If a patient has a gene variant
making tamoxifen not medically appropriate, W does not pay for the
tamoxifen prescription.
(ii) Conclusion. In this Example 3, W does not violate paragraph
(e) of this section if it conditions future payments for the
tamoxifen prescription on K's undergoing a genetic test to determine
the genetic markers K has for making the CYP2D6 enzyme. W
also does not violate paragraph (e) of this section if it refuses
future payment if the results of the genetic test indicate that
tamoxifen is not medically appropriate for K.
(h) Applicability date. The provisions of this section are
effective with respect to health insurance coverage offered, sold,
issued, renewed, in effect, or operated in the individual market on or
after December 7, 2009.
0
15. The heading for subpart D is revised to read as follows:
Subpart D--Preemption; Excepted Benefits
0
16. Section 148.220 is amended by adding two new sentences at the end
of paragraph (b)(4) to read as follows:
Sec. 148.220 Excepted benefits.
* * * * *
(b) * * *
(4) * * *. The requirements of this part 148 (including genetic
nondiscrimination requirements), do not apply to Medicare supplemental
health insurance policies. However, Medicare supplemental health
insurance policies are subject to similar genetic nondiscrimination
requirements under section 104 of the Genetic Information
Nondiscrimination Act of 2008 (Pub. L. 110-233), as incorporated into
the NAIC Model Regulation relating to sections 1882(s)(2)(e) and (x) of
the Act (The NAIC Model Regulation can be accessed at http://www.naic.org.).
* * * * *
[[Page 51697]]
Approved: May 7, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: May 15, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-22504 Filed 10-1-09; 11:15 am]
BILLING CODE 4830-01-P; 4510-29-P; 4120-01-P