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10 October 2008


[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.

-----------------------------------------------------------------------

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]