[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Proposed Rules]
[Page 60208-60211]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc08-24]
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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: http://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 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 HHS. Comments to the Department of HHS, identified by
CMS-4137-NC, 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-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: 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) 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]