Request for Information Regarding Sections 101 Through 104 of the Genetic Information Nondiscrimination Act of 2008, 60208-60211 [E8-24194]
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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Proposed Rules
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
3. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this proposed AD and placed it in the
AD docket.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new AD:
Bombardier, Inc. (Formerly de Havilland,
Inc.): Docket No. FAA–2008–1083;
Directorate Identifier 2008–NM–130–AD.
Comments Due Date
(a) We must receive comments by
November 10, 2008.
Affected ADs
(b) None.
Applicability
(c) This AD applies to Bombardier Model
DHC–8–400, DHC–8–401, and DHC–8–402
airplanes, certificated in any category, Serial
numbers 4003, 4004, 4006, and 4008 through
4184 inclusive.
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Subject
(d) Air Transport Association (ATA) of
America Code 32: Landing Gear.
Reason
(e) The mandatory continuing
airworthiness information (MCAI) states:
‘‘There have been several cases reported
where the landing gear did not retract after
take-off. Subsequent investigation revealed
this was caused by fatigue failure of the nose
landing gear electrical harness. In
conjunction with one engine being
inoperable, this could, in certain operating
conditions, affect continued safe flight and
landing.’’
‘‘This directive mandates incorporation of
new weight-on-wheels (WOW) and steering
harnesses that have a new conduit
construction.’’
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Actions and Compliance
DEPARTMENT OF THE TREASURY
(f) Unless already done, do the following
actions.
(1) Within 2,500 flight hours after the
effective date of this AD, replace the WOW
and steering harnesses by incorporating
Modsum 4–126401, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin 84–32–51, Revision ‘B,’
dated December 17, 2007.
(2) Actions done before the effective date
of this AD in accordance with Bombardier
Service Bulletin 84–32–51, dated August 16,
2007, or Revision ‘A,’ dated August 22, 2007,
are acceptable for compliance with the
corresponding requirements of this AD.
Note: This AD differs from the MCAI and/
or service information as follows: No
differences.
Other FAA AD Provisions
(g) The following provisions also apply to
this AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, Systems and Flight
Test Branch, ANE–172, FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. Send information to ATTN: Wing
Chan, Aerospace Engineer, Systems and
Flight Test Branch, ANE–172, FAA, New
York Aircraft Certification Office, 1600
Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone (516) 228–7311; fax
(516) 794–5531. Before using any approved
AMOC on any airplane to which the AMOC
applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your
local FSDO.
(2) Airworthy Product: For any
requirement in this AD to obtain corrective
actions from a manufacturer or other source,
use these actions if they are FAA-approved.
Corrective actions are considered FAAapproved if they are approved by the State
of Design Authority (or their delegated
agent). You are required to assure the product
is airworthy before it is returned to service.
(3) Reporting Requirements: For any
reporting requirement in this AD, under the
provisions of the Paperwork Reduction Act,
the Office of Management and Budget (OMB)
has approved the information collection
requirements and has assigned OMB Control
Number 2120–0056.
Related Information
(h) Refer to MCAI Canadian Airworthiness
Directive CF–2008–22, dated June 24, 2008,
and Bombardier Service Bulletin 84–32–51,
Revision ‘B,’ dated December 17, 2007, for
related information.
Issued in Renton, Washington, on October
2, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E8–24161 Filed 10–9–08; 8:45 am]
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Employee Benefits Security
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29 CFR Part 2590
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FAA AD Differences
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CMS–4137–NC]
45 CFR Parts 144, 146, and 148
RIN 0938–AP37
Request for Information Regarding
Sections 101 Through 104 of the
Genetic Information Nondiscrimination
Act of 2008
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: Request for Information.
AGENCIES:
SUMMARY: This document is a request for
comments regarding issues under
sections 101 through 104 of the Genetic
Information Nondiscrimination Act of
2008 (GINA). The Departments of Labor,
Health and Human Services (HHS), and
the Treasury (collectively, the
Departments) have received inquiries
from the public on a number of issues
under these provisions and are
welcoming public comments in advance
of future rulemaking.
DATES: Comments must be submitted on
or before December 9, 2008.
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 by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: E–OHPSCA.EBSA@dol.gov.
• Mail or Hand Delivery: Office of
Health Plan Standards and Compliance
Assistance, Employee Benefits Security
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Administration, Room N–5653, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210,
Attention: GINA Comments.
Comments received by the
Department of Labor will be posted
without change to https://
www.regulations.gov and https://
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 HHS. Comments to the
Department of HHS, identified by CMS–
4137–NC, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–4137–NC, 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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: CC:PA:LPD:PR (REG–123829–
08), Room 5205, Internal Revenue
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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 (https://
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)
was enacted on May 21, 2008 (Pub. L.
110–233). Title I of GINA amends 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. Sections 101
through 104 of GINA apply to
employment-based health coverage,
individual market health insurance, and
Medicare supplemental (MedSupp or
Medigap) coverage. The new
requirements were added to Part 7 of
Subtitle B of Title I of ERISA, Title
XXVII of the PHS Act, Subtitle K of the
Code, and section 1882 of the SSA.
GINA prohibits group health plans
and health insurance issuers (that is,
insurance companies or health
maintenance organizations (HMOs)) in
the group market from using genetic
information to adjust premium or
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contribution amounts for the group
covered under the plan. Plans and
issuers in the group market are still
allowed to increase the premium rate for
an employer based on the manifestation
of a disease or disorder of an individual
enrolled in the plan, but they are
prohibited from using the manifested
disease or disorder of one individual as
genetic information about other group
members to further increase the
premium.
In the individual market, health
insurance issuers are prohibited from
using genetic information to determine
individual eligibility or premium rates,
although they are allowed (to the extent
consistent with other provisions of law)
to use information about a manifestation
of a disease or disorder to determine
eligibility or premium rates for an
individual who is covered or would be
covered by a policy. Individual market
health insurance issuers are also
prohibited from using genetic
information in imposing a preexisting
condition exclusion, although a
manifestation of a disease or disorder in
an individual can be the basis for an
exclusion. In the MedSupp market,
GINA prohibits issuers from denying or
conditioning the issuance or
effectiveness of a policy (including the
imposition of any exclusion of benefits
based on a preexisting condition) or
discriminating in the pricing of the
policy based on an individual’s genetic
condition. However, if otherwise
permitted under section 1882 of the
Social Security Act, the issuer can still
impose such limitations based on a
manifested disease of an individual who
is covered or would be covered under
the policy.
GINA also prohibits group health
plans and health insurance issuers in
the group, individual, and MedSupp
markets from requesting or requiring an
individual or family member of an
individual to undergo a genetic test.
Plans and issuers are not precluded
from obtaining and using the results of
a genetic test to make a determination
regarding payment, but they may only
use the minimum amount of
information necessary.
GINA includes a research exception
under which a group health plan or a
health insurance issuer in the group,
individual, or MedSupp market may
request (but not require) a participant or
beneficiary to undergo a genetic test if
the following five conditions are met:
• The request is made in writing
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
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protection of human subjects in
research.
• The plan or issuer clearly indicates
to each participant or beneficiary to
whom the request is made that
compliance is voluntary and noncompliance will have no effect on
enrollment status or premium
contribution amounts.
• None of the genetic information
collected can be used for underwriting
purposes.
• The plan or issuer notifies the
appropriate Secretary in writing that it
is conducting such research activities,
including a description of the activities
conducted.
• The plan or issuer complies with
such other conditions as may be
required by regulations for such
activities.
Group health plans and health
insurance issuers in the group,
individual, and MedSupp markets are
prohibited from requesting, requiring, or
purchasing genetic information for
underwriting purposes or prior to an
individual’s enrollment under a plan or
policy. Plans and issuers are still
allowed to collect (that is, to request,
require, or purchase) health information
that relates to the manifestation of a
disease or disorder of an individual
enrolled in a plan or who is covered by
or would be covered by a policy issued
in the individual or MedSupp market,
and use it for permitted underwriting
purposes with respect to that
individual. Furthermore, an exception
to the prohibition on requesting,
requiring, or purchasing genetic
information is included for collection of
genetic information which is incidental
to the request, requirement, or purchase
of other information concerning an
individual, provided it is not used for
underwriting purposes.
GINA defines genetic information
with respect to any individual as
information about that individual’s
genetic tests, the genetic tests of family
members of the individual, and the
manifestation of a disease or disorder in
family members of the individual. The
term genetic information also includes
an individual’s request for, or receipt of,
genetic services, but does not include
information about the sex or age of any
individual. Genetic services are further
defined as a genetic test, genetic
counseling (which includes obtaining,
interpreting, or assessing genetic
information), or genetic education. A
genetic test is defined for purposes of
Title I of GINA as an analysis of human
DNA, RNA, chromosomes, proteins, or
metabolites that detects genotypes,
mutations, or chromosomal changes.
The term is not meant to include an
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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
a health care professional with
appropriate training and expertise could
reasonably detect. Definitions of family
member and underwriting purposes are
also included, as well as provisions
clarifying that references to genetic
information concerning an individual
include the genetic information of a
fetus carried by a pregnant woman and
of an embryo legally held by an
individual utilizing an assisted
reproductive technology.
The provisions of GINA are effective
with respect to group health plans and
health insurance issuers in the group
market for plan years beginning after
May 21, 2009. For health insurance
issuers in the individual market, the
provisions are effective with respect to
health insurance coverage sold, issued,
renewed, in effect, or operated in the
individual market after May 21, 2009.
For MedSupp coverage, States must
incorporate the GINA provisions into
their regulatory programs no later than
July 1, 2009.
II. Solicitation of Comments
A. Comments Regarding Economic
Analysis, Paperwork Reduction Act, and
Regulatory Flexibility Act
Executive Order 12866 requires an
assessment of the costs and benefits of
a significant rulemaking action and the
alternatives considered, using the
guidance provided by the Office of
Management and Budget. These costs
and benefits are not limited to the
Federal government, but pertain to the
affected public as a whole. Under
Executive Order 12866, a determination
must be made whether implementation
of GINA sections 101 through 104 will
be economically significant. A rule that
has an annual effect on the economy of
$100 million or more is considered
economically significant.
In addition, the Regulatory Flexibility
Act may require the preparation of an
analysis of the economic impact on
small entities of proposed rules and
regulatory alternatives. An analysis
under the Regulatory Flexibility Act
must generally include, among other
things, an estimate of the number of
small entities subject to the regulations
(for this purpose, plans, employers, and
issuers and, in some contexts small
governmental entities), the expense of
the reporting and other compliance
requirements (including the expense of
using professional expertise), and a
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description of any significant regulatory
alternatives considered that would
accomplish the stated objectives of the
statute and minimize the impact on
small entities. The Departments seek
additional information from small
entities regarding any special problems
they might encounter in implementing
the requirements of sections 101
through 104 of GINA and any regulatory
guidance that might minimize those
problems.
The Paperwork Reduction Act
requires an estimate of how many
‘‘respondents’’ will be required to
comply with any ‘‘collection of
information’’ aspects of the regulations
and how much time and cost will be
incurred as a result. A collection of
information includes record-keeping,
reporting to governmental agencies, and
third-party disclosures.
The Departments are requesting
comments that may contribute to the
analyses that will be performed under
these requirements, both generally and
with respect to the following specific
areas:
(i) What policies, procedures, or
practices of group health plans and
health insurance issuers may be
impacted by regulations under GINA?
What direct or indirect costs would
result? What direct or indirect benefits
would result? Which stakeholders will
be impacted by such benefits and costs?
(ii) Are there unique costs and
benefits for small employers or small
plans? What special consideration, if
any, is needed for small employers or
small plans?
B. Comments Regarding Regulatory
Guidance
The Departments are seeking
comments to aid in the development of
regulations regarding sections 101
through 104 of GINA. To assist
interested parties in responding, this
request for information describes
specific areas in which the Departments
are particularly interested; however, the
Departments also request comments and
suggestions concerning any area or issue
pertinent to the development of
regulations.
Specific Areas in Which the
Departments Are Interested Include the
Following
1. To what extent do group health
plans and health insurance issuers
currently use genetic information, such
as family medical history, and for what
purposes? For example, is genetic
information currently used for group
rating purposes, or for purposes of a
wellness program that otherwise
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complies with HIPAA’s
nondiscrimination requirements?
2. How do plans and issuers currently
obtain genetic information (for example,
through health risk assessments, the
Medical Information Bureau, or other
entities under common control)?
3. Under what circumstances do plans
or issuers currently request or require an
individual to take a genetic test?
4. Under what circumstances do plans
or issuers currently ask for the results of
a genetic test in order to make a
determination regarding payment of
benefits? What is the minimum amount
of information necessary for a plan or
issuer to make a determination under
such circumstances?
5. What types of research do plans or
issuers currently conduct or support
using genetic tests?
6. Would a model notice be helpful to
facilitate disclosure to plan participants
and beneficiaries regarding a plan’s or
issuer’s use of the research exception?
In this regard, what information would
be most helpful to participants and
beneficiaries?
7. Similarly, would a model form be
helpful for reporting to the Departments
by a plan or issuer claiming the research
exception? In this regard, what
information should plans and issuers
report?
8. When might genetic information be
collected incidentally?
9. What terms or provisions (such as
genetic information, genetic test, genetic
services, or underwriting) would require
additional clarification to facilitate
compliance? What specific clarifications
would be helpful?
Signed at Washington, DC this 4th day of
June, 2008.
Alan Tawshunsky,
Deputy Division Counsel/Deputy Associate
Chief Counsel, Tax Exempt and Government
Entities, Internal Revenue Service,
Department of the Treasury.
Signed at Washington, DC this 5th day of
June, 2008.
W. Thomas Reeder,
Benefits Tax Counsel, Department of the
Treasury.
Signed at Washington, DC this 2nd day of
October, 2008.
Bradford P. Campbell,
Assistant Secretary, Employee Benefits
Security Administration, U.S. Department of
Labor.
Dated: June 30, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 158 and 161
[EPA–HQ–OPP–2008–0110; FRL–8383–6]
Data Requirements for Antimicrobial
Pesticides; Notice of Public Workshop
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; notice of public
workshop.
AGENCY:
SUMMARY: EPA is convening a public
workshop to explain the provisions of
its recently proposed rule to update and
revise the data requirements for
registration of antimicrobial pesticides.
The workshop is intended to provide an
opportunity for members of the public
to ask questions about the proposed rule
and seek any clarification they believe
may assist them in submitting
comments to the docket for the
proposed rule. Any person wishing to
comment on the proposed rule must
submit any comments to the docket
within the timeframe set forth in the
Notice of Proposed Rulemaking.
DATES: The meeting will be held on
November 6, 2008, from 8:30 a.m. to
4:00 p.m.
To request accommodation of a
disability, please contact the person
listed under FOR FURTHER INFORMATON
CONTACT, preferably at least 10 days
prior to the meeting, to give EPA as
much time as possible to process your
request.
ADDRESSES: The meeting will be held at
the Office of Pesticide Programs (OPP),
First Floor Conference Center, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA 22202.
To facilitate the Agency’s planning,
your intention to participate in the
Antimicrobials Workshop, may be
submitted to the person listed under FOR
FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Kathryn Boyle, Field and External
Affairs Division (7506P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: 703.305.6304;
fax number: 703.305.5884; e-mail
address: boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if
you are a producer of pesticide products
(NAICS code 32532), antifoulants
(NAICS code 32551), antimicrobial
pesticides (NAICS code 32561) or wood
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preservatives (NAICS code 32519),
importers of such products, or any
person or company who seeks to register
an antimicrobial, antifoulant coating,
ballast water treatment, or wood
preservative pesticide or to obtain a
tolerance for such a pesticide. This
listing is not intended to be exhaustive,
but rather provides a guide for readers
regarding entities likely to be affected by
this action. Other types of entities not
listed above could also be affected. The
North American Industrial
Classification System (NAICS) codes
have been provided to assist you and
others in determining whether this
action might apply to certain entities. If
you have any questions regarding the
applicability of this action to a
particular entity, please contact Norm
Cook, Chief of the Risk Assessment and
Science Support Branch in the
Antimicrobials Division of the Office of
Pesticide Programs at 703–308–8253 or
via email, cook.norm@epa.gov.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under docket ID
number EPA–HQ–OPP–2008–0110.
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA 22202. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr.
II. Background
EPA is convening a public workshop
to explain the proposed revisions to the
data requirements for the registration of
antimicrobial pesticides. Under the
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and the
Federal Food, Drug and Cosmetic Act
(FFDCA), anyone seeking to register a
pesticide product is required to provide
information to EPA to demonstrate that
their products can be used without
posing ‘‘unreasonable adverse effects on
the environment’’ as defined by FIFRA
section 2(bb).
The public workshop will include
presentations by staff from the
Antimicrobial, and the Field and
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]]>Agencies
[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Proposed Rules]
[Pages 60208-60211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24194]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG-123829-08]
RIN 1545-BI02
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AB27
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[CMS-4137-NC]
45 CFR Parts 144, 146, and 148
RIN 0938-AP37
Request for Information Regarding Sections 101 Through 104 of the
Genetic Information Nondiscrimination Act of 2008
AGENCIES: 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: Request for Information.
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SUMMARY: This document is a request for comments regarding issues under
sections 101 through 104 of the Genetic Information Nondiscrimination
Act of 2008 (GINA). The Departments of Labor, Health and Human Services
(HHS), and the Treasury (collectively, the Departments) have received
inquiries from the public on a number of issues under these provisions
and are welcoming public comments in advance of future rulemaking.
DATES: Comments must be submitted on or before December 9, 2008.
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 by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: E-OHPSCA.EBSA@dol.gov.
Mail or Hand Delivery: Office of Health Plan Standards and
Compliance Assistance, Employee Benefits Security
[[Page 60209]]
Administration, Room N-5653, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210, Attention: GINA Comments.
Comments received by the Department of Labor will be posted without
change to https://www.regulations.gov and https://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 HHS. Comments to the Department of HHS, identified by
CMS-4137-NC, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Centers for Medicare & Medicaid Services, Department
of Health and Human Services, Attention: CMS-4137-NC, 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: https://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 (https://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) was
enacted on May 21, 2008 (Pub. L. 110-233). Title I of GINA amends 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. Sections 101 through 104 of GINA
apply to employment-based health coverage, individual market health
insurance, and Medicare supplemental (MedSupp or Medigap) coverage. The
new requirements were added to Part 7 of Subtitle B of Title I of
ERISA, Title XXVII of the PHS Act, Subtitle K of the Code, and section
1882 of the SSA.
GINA prohibits group health plans and health insurance issuers
(that is, insurance companies or health maintenance organizations
(HMOs)) in the group market from using genetic information to adjust
premium or contribution amounts for the group covered under the plan.
Plans and issuers in the group market are still allowed to increase the
premium rate for an employer based on the manifestation of a disease or
disorder of an individual enrolled in the plan, but they are prohibited
from using the manifested disease or disorder of one individual as
genetic information about other group members to further increase the
premium.
In the individual market, health insurance issuers are prohibited
from using genetic information to determine individual eligibility or
premium rates, although they are allowed (to the extent consistent with
other provisions of law) to use information about a manifestation of a
disease or disorder to determine eligibility or premium rates for an
individual who is covered or would be covered by a policy. Individual
market health insurance issuers are also prohibited from using genetic
information in imposing a preexisting condition exclusion, although a
manifestation of a disease or disorder in an individual can be the
basis for an exclusion. In the MedSupp market, GINA prohibits issuers
from denying or conditioning the issuance or effectiveness of a policy
(including the imposition of any exclusion of benefits based on a
preexisting condition) or discriminating in the pricing of the policy
based on an individual's genetic condition. However, if otherwise
permitted under section 1882 of the Social Security Act, the issuer can
still impose such limitations based on a manifested disease of an
individual who is covered or would be covered under the policy.
GINA also prohibits group health plans and health insurance issuers
in the group, individual, and MedSupp markets from requesting or
requiring an individual or family member of an individual to undergo a
genetic test. Plans and issuers are not precluded from obtaining and
using the results of a genetic test to make a determination regarding
payment, but they may only use the minimum amount of information
necessary.
GINA includes a research exception under which a group health plan
or a health insurance issuer in the group, individual, or MedSupp
market may request (but not require) a participant or beneficiary to
undergo a genetic test if the following five conditions are met:
The request is made in writing 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
[[Page 60210]]
protection of human subjects in research.
The plan or issuer clearly indicates to each participant
or beneficiary to whom the request is made that compliance is voluntary
and non-compliance will have no effect on enrollment status or premium
contribution amounts.
None of the genetic information collected can be used for
underwriting purposes.
The plan or issuer notifies the appropriate Secretary in
writing that it is conducting such research activities, including a
description of the activities conducted.
The plan or issuer complies with such other conditions as
may be required by regulations for such activities.
Group health plans and health insurance issuers in the group,
individual, and MedSupp markets are prohibited from requesting,
requiring, or purchasing genetic information for underwriting purposes
or prior to an individual's enrollment under a plan or policy. Plans
and issuers are still allowed to collect (that is, to request, require,
or purchase) health information that relates to the manifestation of a
disease or disorder of an individual enrolled in a plan or who is
covered by or would be covered by a policy issued in the individual or
MedSupp market, and use it for permitted underwriting purposes with
respect to that individual. Furthermore, an exception to the
prohibition on requesting, requiring, or purchasing genetic information
is included for collection of genetic information which is incidental
to the request, requirement, or purchase of other information
concerning an individual, provided it is not used for underwriting
purposes.
GINA defines genetic information with respect to any individual as
information about that individual's genetic tests, the genetic tests of
family members of the individual, and the manifestation of a disease or
disorder in family members of the individual. The term genetic
information also includes an individual's request for, or receipt of,
genetic services, but does not include information about the sex or age
of any individual. Genetic services are further defined as a genetic
test, genetic counseling (which includes obtaining, interpreting, or
assessing genetic information), or genetic education. A genetic test is
defined for purposes of Title I of GINA as an analysis of human DNA,
RNA, chromosomes, proteins, or metabolites that detects genotypes,
mutations, or chromosomal changes. The term is not meant to 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 a health care professional with
appropriate training and expertise could reasonably detect. Definitions
of family member and underwriting purposes are also included, as well
as provisions clarifying that references to genetic information
concerning an individual include the genetic information of a fetus
carried by a pregnant woman and of an embryo legally held by an
individual utilizing an assisted reproductive technology.
The provisions of GINA are effective with respect to group health
plans and health insurance issuers in the group market for plan years
beginning after May 21, 2009. For health insurance issuers in the
individual market, the provisions are effective with respect to health
insurance coverage sold, issued, renewed, in effect, or operated in the
individual market after May 21, 2009. For MedSupp coverage, States must
incorporate the GINA provisions into their regulatory programs no later
than July 1, 2009.
II. Solicitation of Comments
A. Comments Regarding Economic Analysis, Paperwork Reduction Act, and
Regulatory Flexibility Act
Executive Order 12866 requires an assessment of the costs and
benefits of a significant rulemaking action and the alternatives
considered, using the guidance provided by the Office of Management and
Budget. These costs and benefits are not limited to the Federal
government, but pertain to the affected public as a whole. Under
Executive Order 12866, a determination must be made whether
implementation of GINA sections 101 through 104 will be economically
significant. A rule that has an annual effect on the economy of $100
million or more is considered economically significant.
In addition, the Regulatory Flexibility Act may require the
preparation of an analysis of the economic impact on small entities of
proposed rules and regulatory alternatives. An analysis under the
Regulatory Flexibility Act must generally include, among other things,
an estimate of the number of small entities subject to the regulations
(for this purpose, plans, employers, and issuers and, in some contexts
small governmental entities), the expense of the reporting and other
compliance requirements (including the expense of using professional
expertise), and a description of any significant regulatory
alternatives considered that would accomplish the stated objectives of
the statute and minimize the impact on small entities. The Departments
seek additional information from small entities regarding any special
problems they might encounter in implementing the requirements of
sections 101 through 104 of GINA and any regulatory guidance that might
minimize those problems.
The Paperwork Reduction Act requires an estimate of how many
``respondents'' will be required to comply with any ``collection of
information'' aspects of the regulations and how much time and cost
will be incurred as a result. A collection of information includes
record-keeping, reporting to governmental agencies, and third-party
disclosures.
The Departments are requesting comments that may contribute to the
analyses that will be performed under these requirements, both
generally and with respect to the following specific areas:
(i) What policies, procedures, or practices of group health plans
and health insurance issuers may be impacted by regulations under GINA?
What direct or indirect costs would result? What direct or indirect
benefits would result? Which stakeholders will be impacted by such
benefits and costs?
(ii) Are there unique costs and benefits for small employers or
small plans? What special consideration, if any, is needed for small
employers or small plans?
B. Comments Regarding Regulatory Guidance
The Departments are seeking comments to aid in the development of
regulations regarding sections 101 through 104 of GINA. To assist
interested parties in responding, this request for information
describes specific areas in which the Departments are particularly
interested; however, the Departments also request comments and
suggestions concerning any area or issue pertinent to the development
of regulations.
Specific Areas in Which the Departments Are Interested Include the
Following
1. To what extent do group health plans and health insurance
issuers currently use genetic information, such as family medical
history, and for what purposes? For example, is genetic information
currently used for group rating purposes, or for purposes of a wellness
program that otherwise
[[Page 60211]]
complies with HIPAA's nondiscrimination requirements?
2. How do plans and issuers currently obtain genetic information
(for example, through health risk assessments, the Medical Information
Bureau, or other entities under common control)?
3. Under what circumstances do plans or issuers currently request
or require an individual to take a genetic test?
4. Under what circumstances do plans or issuers currently ask for
the results of a genetic test in order to make a determination
regarding payment of benefits? What is the minimum amount of
information necessary for a plan or issuer to make a determination
under such circumstances?
5. What types of research do plans or issuers currently conduct or
support using genetic tests?
6. Would a model notice be helpful to facilitate disclosure to plan
participants and beneficiaries regarding a plan's or issuer's use of
the research exception? In this regard, what information would be most
helpful to participants and beneficiaries?
7. Similarly, would a model form be helpful for reporting to the
Departments by a plan or issuer claiming the research exception? In
this regard, what information should plans and issuers report?
8. When might genetic information be collected incidentally?
9. What terms or provisions (such as genetic information, genetic
test, genetic services, or underwriting) would require additional
clarification to facilitate compliance? What specific clarifications
would be helpful?
Signed at Washington, DC this 4th day of June, 2008.
Alan Tawshunsky,
Deputy Division Counsel/Deputy Associate Chief Counsel, Tax Exempt and
Government Entities, Internal Revenue Service, Department of the
Treasury.
Signed at Washington, DC this 5th day of June, 2008.
W. Thomas Reeder,
Benefits Tax Counsel, Department of the Treasury.
Signed at Washington, DC this 2nd day of October, 2008.
Bradford P. Campbell,
Assistant Secretary, Employee Benefits Security Administration, U.S.
Department of Labor.
Dated: June 30, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-24194 Filed 10-9-08; 8:45 am]
BILLING CODES 4830-01-P; 4510-29-P; 4120-01-P
