CMS-10286 GINA Research Execption Notice

OMB Control No. 0938-1077
Expiration Date: XX/XX/XX

Instructions to the
Notice of Research Exception under the
Genetic Information Nondiscrimination Act
I. Introduction.
This notice is required to be provided if a group health plan or health insurance issuer intends to
claim the research exception permitted under Title I of the Genetic Information
Nondiscrimination Act of 2008 (GINA). Under GINA, a plan or issuer generally may not
request or require an individual or family member to undergo a genetic test. However, a plan or
issuer may request (but not require) a genetic test in connection with certain research activities so
long as such activities comply with specific requirements, including (i) the research complies
with 45 CFR part 46 or equivalent federal regulations and applicable State or local law or
regulations for the protection of human subjects in research, (ii) the request for the participant or
beneficiary (or in the case of a minor child, the legal guardian of such beneficiary) is made in
writing and clearly indicates that compliance with the request is voluntary and that noncompliance will have no effect on eligibility for benefits or premium or contribution amounts;
and (iii) no genetic information collected or acquired will be used for underwriting purposes.
If there is no group health plan or health insurance issuer involved in the research, this form is
not required to be filed.
II. Definitions
“Church Plan”
In general, a church plan is a plan established or maintained for its employees or their
beneficiaries by a church or by a convention or association of churches that is exempt from tax
under section 501 of the Internal Revenue Code (Code).
“Employer Identification Number” or “EIN”
An EIN is a nine-digit employer identification number (for example, 00-1234567) that has been
assigned by the Internal Revenue Service (IRS). Entities that do not have an EIN should apply
for one on Form SS-4, Application for Employer Identification Number as soon as possible.
You can obtain Form SS-4 by calling 1-800-829-4933 or at the IRS Web site at www.irs.gov.
“Group Health Insurance Coverage”
Group health insurance coverage means health insurance coverage offered in connection with a
group health plan.
“Group Health Plan”
In general, a group health plan means an employee welfare benefit plan to the extent that the plan
provides benefits for medical care to employees (including both current and former employees)
or their dependents (as defined under the terms of the plan) directly or through insurance,
reimbursement, or otherwise. See section 733(a) of the Employee Retirement Income Security
Act (ERISA) and 29 CFR 2590.732(a). See also section 5000(b)(1) of the Code.

“Health Insurance Coverage”
Health insurance coverage means benefits consisting of medical care (provided directly, through
insurance or reimbursement, or otherwise) under any hospital or medical service policy or
certificate, hospital or medical service plan contract, or HMO contract offered by a health
insurance issuer. Health insurance coverage includes group health insurance coverage and
individual health insurance coverage.
“Health Insurance Issuer” or “Issuer”
The term “health insurance issuer” or “issuer” is defined, in pertinent part, in 29 CFR 2590.701-2
as “an insurance company, insurance service, or insurance organization (including an HMO) that
is required to be licensed to engage in the business of insurance in a State and that is subject to
State law which regulates insurance….Such term does not include a group health plan.”
“Individual Health Insurance Coverage”
Individual health insurance coverage means health insurance coverage offered to individuals in
the individual market, but does not include short-term, limited duration insurance. Individual
health insurance coverage can include dependent coverage.
“Nonfederal Governmental Plan”
Nonfederal governmental plan means a governmental plan that is not a Federal governmental
plan.
“Medigap Coverage”
Medigap coverage means Medicare supplemental insurance coverage offered to individuals
enrolled in Original Medicare.
“Plan Number” or “PN”
A PN is a three-digit number assigned to a plan or other entity by an employer or plan
administrator. For plans or other entities providing welfare benefits, the first plan number should
be number 501 and additional plans should be numbered consecutively.
“Underwriting Purposes”
Underwriting purposes, with respect to any group health plan, or health insurance coverage
offered in connection with a group health plan—
• Rules for, or determination of eligibility (including enrollment and continued eligibility)
for benefits under the plan or coverage;
• The computation of premium or contribution amounts under the plan or coverage;
• The application of any preexisting condition exclusion under the plan or coverage; and
• Other activities related to the creation, renewal, or replacement of a contract of health
insurance or health benefits.

III. Where to File.

A. Church Plans. A church plan (as defined in section 414(e) of the Code) claiming the
research exception must provide this notice to the IRS at:
Internal Revenue Service
Cincinnati Compliance Services (CEO)
Attn: MS 8100G
201 West Rivercenter Blvd
Covington, KY 41011
B. Group Health Plans and Issuers Subject to ERISA. A group health plan, or a health
insurance issuer offering health insurance coverage in connection with a group health
plan, subject to Part 7 of Subtitle B of Title I of ERISA claiming the research exception
for any genetic testing request must provide notice to the Department of Labor at:
Public Disclosure Office, EBSA
Room N-1513, U.S. Department of Labor
200 Constitution Avenue, N.W.
Washington, DC 20210
C. Nonfederal Governmental Plans. A group health plan that is a nonfederal governmental
plan claiming the research exception, or a health insurance issuer claiming this exception
in connection with the provision of group health insurance coverage provided only to
nonfederal governmental plans, must provide notice to the Department of Health and
Human Services at:
Centers for Medicare & Medicaid Services
Center for Consumer Information & Insurance Oversight
Room 739H
200 Independence Avenue, SW
Washington, DC 20201
D. Health Insurance Issuers Claiming the Exception Only for Individual Insurance Coverage
or Only for Medigap coverage or for Both Individual Insurance Coverage and Medigap
Coverage. A health insurance issuer claiming the research exception in connection with
the provision of health insurance coverage provided only in the individual insurance
market or the Medigap market or both, must provide notice to the Department of Health
and Human Services at:
Centers for Medicare & Medicaid Services
Center for Consumer Information & Insurance Oversight
Room 739H
200 Independence Avenue, SW
Washington, DC 20201
E. Health Insurance Issuers Claiming the Exception for Only Group Insurance Coverage or
for Group and Individual Insurance Coverage and/or Medigap Coverage. A health
insurance issuer claiming the research exception in connection with the provision of
health insurance coverage provided only in the group market, or health insurance

coverage provided in the group as well as individual and/or Medigap markets, must
provide notice to the Department of Labor at:
Public Disclosure Office, EBSA
Room N-1513, U.S. Department of Labor
200 Constitution Avenue, N.W.
Washington, DC 20210
IV. When to File.
A plan or issuer claiming the research exception must file at least 60 days prior to the date the
first request is made to a participant or beneficiary to undergo a genetic test.
V. Attaching Additional Pages
For paper filings, if more space is needed to complete any item on the Notice of Research
Exception, additional pages may be attached. Additional pages must be the same size as this
form (8 ½” x 11”) and should include the name of the entity claiming exception, the title of the
research project, the item number, and the word “Attachment” in the upper right corner. In
addition, the attachment for any item should be in a format similar to that item on the form.
If filing online, these additional pages may be uploaded online at the Web filing site.
VI. Line-by-Line Instructions
Part I: Entity Classification and Identification
Item 1: Enter the date this filing is being submitted.
Item 2: Check either box 2(A) or box 2(B).
Box 2(A): Check this box if the entity claiming the research exception is a group health
plan. (See Section II for the definition of a group health plan.)
Box 2(B): Check this box if the entity claiming the research exception is a health
insurance issuer. (See Section II for the definition of a health insurance issuer.)
If you checked box 2(A), complete item 3 and skip item 4. If you checked box 2(B), skip
item 3 and complete item 4.
Item 3: If you checked box 2(A), check one of the following: box 3(A), box 3(B), or box 3(C).
Box 3(A): Check this box if the entity is a group health plan subject to Part 7 of Title I of
ERISA. (See Section II for a discussion of plans subject to Part 7 of Title I of ERISA.)
Box 3(B): Check this box if the entity is a group health plan that is a church plan (See
Section II for the definition of a church plan.)
Box 3(C): Check this box if the entity is a group health plan that is a nonfederal
governmental plan. (See Section II for the definition of a nonfederal governmental plan.)
Item 4: If you checked box 2(B), check one of the following: box 4(A), box 4(B), or box 4(C).
Box 4(A): Check this box if the entity is a health insurance issuer claiming the exception
in connection with the provision of group health insurance coverage only.

Box 4(B): Check this box if the entity is a health insurance issuer claiming the exception
in connection with the provision of individual health insurance coverage only.
Box 4(C): Check this box if the entity is a health insurance issuer claiming the exception
in connection with the provision of Medigap coverage only.
Box 4(D): Check this box if the entity is a health insurance issuer claiming the exception
in connection with the provision of both individual health insurance and Medigap coverages.
Box 4(E): Check this box if the entity is a health insurance issuer claiming the exception
in connection with group as well as individual health insurance coverage and/or Medigap
coverage.
Items 5a through 5d: Enter the name, address, and telephone number of the entity claiming the
research exception, and any EIN or PN used by the entity in reporting to the Department of
Labor or the Internal Revenue Service. If the entity does not have any EINs associated with it,
leave item 5c blank. If the entity does not have any PNs associated with it, leave item 5d blank.
For more information on EINs or PBs, see Section II on Definitions.
Part II: Research Project Information
Item 6: Provide the title of the research project.
Item 7: Provide the name of the principal investigator for the research project.
Item 8: Provide the research project number, if available.
Part III: Attestation of Compliance with the Requirements of the Research Exception
Sign the attestation, certifying compliance with the requirements of the research exception and
declaring the contents of the filing true and correct. Type or print the relevant contact
information.

Paperwork Reduction Act Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless such collection displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-1077. The time required to complete this collection of information is estimated to
average 15 minutes per response, including time for reviewing instructions, gathering the data needed, and
completing and reviewing the collection of information. The obligation to respond to this collection is required to
obtain or retain a benefit (see sections 102(a)(2) and (b)(1)(B) of the Genetic Information Nondiscrimination Act,
P.L. 110-233). Please send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the U.S. Department of Health and Human Services,
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850 and reference the OMB Control Number. Note: Please do not
return the completed application to this address.

OMB Control No. 0938-1077
Expiration Date: 09/30/2019

Notice of Research Exception
Under
The Genetic Information Nondiscrimination Act

PART I: Entity Classification and Identification
1. Date of submission: __________________________
2. Specify whether the entity claiming the research exception is:
(A)  A group health plan (plan); or
(B)  A health insurance issuer (issuer).
3. If the entity is a plan (as designated in Box 2A), is the plan:
(A)  A plan subject to Part 7 of Title I of ERISA;
(B)  A church plan; or
(C)  A nonfederal governmental plan.
4. If the entity is an issuer (as designated in Box 2B), is the issuer claiming the exception in
connection with the provision of:
(A)  Group health insurance coverage only;
(B)  Individual health insurance coverage only;
(C)  Medigap coverage only;
(D)  Both individual health insurance coverage and Medigap coverage; or
(E) Group as well as individual health insurance coverage and/or Medigap
coverage.
5a. Name and address of the entity claiming the exception:
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________

5b. Telephone number of the entity claiming the exception:
________________________________________________________
5c. Employer Identification Number (EIN) of the entity claiming the exception:
________________________________________________________
5d. If the entity is a plan (as designated in Box 2A), specify plan number:
________________________________________________________
PART II: Research Project Information
6. Title of the research project:
________________________________________________________
7. Name of the principal investigator:
________________________________________________________
8. Research project number (if available):
________________________________________________________
Part III: Attestation of Compliance with the Requirements of the Research Exception
With respect to the research project described in Part II, I attest that the following is true:
(i) The research complies with 45 CFR part 46 or equivalent federal regulations and
applicable State or local law or regulations for the protection of human subjects in research;
(ii) each request of a participant or beneficiary (or in the case of a minor child, the legal
guardian of such beneficiary) to undergo genetic testing as part of the research will be made
in writing and clearly indicate that compliance with the request is voluntary and that noncompliance will have no effect on eligibility for benefits or premium or contribution
amounts; and (iii) no genetic information collected or acquired through this research will be
used for underwriting purposes.
Under penalty of perjury, I declare that I have examined this notice, including any
accompanying attachments, and to the best of my knowledge and belief, it is true and
correct. Under penalty of perjury, I also declare that this notice is complete.
Signature: _______________________________

Date: _________________

Type or print name, address, and telephone number:
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________

Paperwork Reduction Act Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless such collection displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-1077. The time required to complete this collection of information is estimated to
average 15 minutes per response, including time for reviewing instructions, gathering the data needed, and
completing and reviewing the collection of information. The obligation to respond to this collection is required to
obtain or retain a benefit (see sections 102(a)(2) and (b)(1)(B) of the Genetic Information Nondiscrimination Act,
P.L. 110-233). Please send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the U.S. Department of Health and Human Services,
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850 and reference the OMB Control Number. Note: Please do not
return the completed application to this address.