CMS-10286 Supporting Statement - Part A_30d

Supporting Statement – Part A
Notice of Research Exception under the Genetic Information Nondiscrimination Act
(OMB Control No. 0938-1077)
A. Background
The Genetic Information Nondiscrimination Act of 2008 (GINA), Public Law 110-233, was
enacted on May 21, 2008. Title I of GINA amended the Employee Retirement Income
Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), the Internal Revenue
Code of 1986 (Code), and the Social Security Act (SSA) to prohibit discrimination in health
coverage based on genetic information. Sections 101 through 104 of Title I of GINA prevent
employment-based group health plans, health insurance issuers in the group and individual
markets, and issuers of Medicare supplemental (Medigap) policies from discriminating based
on genetic information.
Under GINA, group health plans and health insurance issuers in the group, individual and
Medigap markets (i.e., insurance companies or health maintenance organizations (HMOs))
cannot collect (defined in the regulations to mean “request, require, or purchase”) genetic
information for underwriting purposes or prior to or in connection with an individual’s
enrollment under the plan or coverage. With a few limited exceptions, plans and issuers are
also prohibited from requesting or requiring an individual or family member to undergo a
genetic test.
One of the exceptions to the prohibition from requesting or requiring an individual (or family
member) to undergo a genetic test is the research exception. 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 non-compliance 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.
The Secretary of Labor or the Secretary of Health and Human Services is required to be
notified if a group health plan or health insurance issuer intends to claim the research
exception permitted under Title I of GINA. Group health plans of private employers, issuers
in group health insurance market, and issuers in the group as well as individual and/or
Medigap markets will be required to notify the Department of Labor. Nonfederal
governmental group health plans and issuers solely in the individual health insurance or
Medigap market will be required to file with the Centers for Medicare & Medicaid Services
(CMS).

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The Notice of Research Exception under the Genetic Information Nondiscrimination Act (the
Notice) is a model notice that can be completed by group health plans and health insurance
issuers and filed with either the Department of Labor or CMS to comply with the notification
requirement.
B. Justification
1 . Need and Legal Basis
The Notice must be used by nonfederal governmental group health plans and by issuers solely
in the individual health insurance market and/or Medigap market to file the required
information with CMS as mandated by sections 2702(c)(4)(D) and 2753(d)(4)(D) of the
Public Health Service Act. This information collection will permit CMS to track those health
insurance issuers that are conducting genetic research and must comply with the genetic
research requirements of GINA.
2.

Information Users
The Notice must be submitted by mail to CMS by nonfederal group health plans and issuers
solely in the individual health insurance market and /or Medigap market who are conducting
genetic research and are requesting individual beneficiaries to participate in genetic testing.

3.

Use of Information Technology
Information will not be collected electronically. The hard copy forms submitted by mail and
are required to be signed.

4.

Duplication of Efforts
There is no duplication of effort regarding the Notice. Staff from CMS has coordinated with
staff from the Departments of the Treasury and Labor in developing the Notice. Group health
plans of private employers, issuers in group health insurance market, and issuers in the group
market as well as the individual and/or Medigap markets will be required to file the Notice
with the Department of Labor. Nonfederal governmental group health plans and issuers solely
in the individual health insurance market and/or Medigap market will be required to file with
CMS.

5.

Small Businesses
The information collection does not impose any burden on small businesses or entities.

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6.

Less Frequent Collection
This is a one-time collection. If the information collection is not conducted, CMS will not be
notified as to which nonfederal governmental plans and issuers in the individual or Medigap
market are conducting genetic research in a manner that is in compliance with GINA.

7.

Special Circumstances
There are no special circumstances.

8.

Federal Register/Outside Consultation
A Federal Register notice was published on May 3, 2013 (78 FR 26035), providing the public
with a 60-day period to submit written comments on the information collection requirement
(ICR). No comments were received.

9.

Payments/Gifts to Respondents
No payments or gifts are associated with this ICR.

10. Confidentiality
No personal identifiable information is being collected. CMS will protect privacy of the
information provided to the extent provided by law.
11. Sensitive Questions
This ICR involves no sensitive questions.
12. Burden Estimates (Hours & Wages)
The burden estimates have been updated based on recent data on labor and mailing costs. We
generally used data from the Bureau of Labor Statistics to derive average labor costs
(including fringe benefits) for estimating the burden associated with the ICR.
CMS estimates that up to two such entities will take advantage of the research exception
annually, and that all of the entities will comply with the requirements of 45 CFR Part 46,
including providing the participant disclosure.
CMS also estimates that completing and mailing the Notice will require 15 minutes of clerical
time at an hourly rate of approximately $31 per hour. Therefore, the total hour burden
associated with completing the Notice is estimated to be 0.5 hours of clerical time. The cost
of materials (paper and ink) for each two page Notice is estimated to be $0.10 and mailing
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cost is $0.46 for each Notice. The total cost burden including material and mailing costs is
estimated to be approximately $16.
13. Capital Costs
There is no capital cost associated with this collection.
14. Cost to Federal Government
There is no cost to the federal government.
15. Changes to Burden
There are no changes to burden.
16. Publication/Tabulation Dates
There are no publication or tabulation dates associated with these ICRs
17. Expiration Date
There is no expiration date for this collection requirement.
18. Certification Statement
There are no exceptions to the certification.

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