02-031 C.M.R. ch. 275, § 24 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing
This section applies to all policies with policy years beginning on or after the effective date of the 2009 amendments to this Rule.
Drafting Note: The federal Genetic Information Nondiscrimination Act of 2008 (GINA) requires issuers to comply with GINA requirements identical to those set forth in this section by May 21, 2009.
A.
An issuer of a Medicare supplement policy or certificate:
(1) Shall not deny or condition the issuance
or effectiveness of the policy or certificate (including the imposition of any
exclusion of benefits under the policy based on a pre-existing condition) on
the basis of the genetic information with respect to such individual;
and
(2) Shall not discriminate in
the pricing of the policy or certificate (including the adjustment of premium
rates) of an individual on the basis of the genetic information with respect to
such individual.
B.
Nothing in Subsection A shall be construed to limit the ability of an issuer,
to the extent otherwise permitted by law, from:
(1) Denying or conditioning the issuance or
effectiveness of the policy or certificate or increasing the premium for a
group based on the manifestation of a disease or disorder of an insured or
applicant; or
(2) Increasing the
premium for any policy issued to an individual based on the manifestation of a
disease or disorder of an individual who is covered under the policy (in such
case, the manifestation of a disease or disorder in one individual cannot also
be used as genetic information about other group members or to further increase
the premium for the group).
C. An issuer of a Medicare supplement policy
or certificate shall not request or require an individual or a family member of
such individual to undergo a genetic test.
D. Subsection C shall not be construed to
preclude an issuer of a Medicare supplement policy or certificate from
obtaining and using the results of a genetic test in making a determination
regarding payment (as defined for the purposes of applying the regulations
promulgated under part C of title XI and Section 264 of the Health Insurance
Portability and Accountability Act of 1996, as may be revised from time to
time) and consistent with Subsection A.
E. For purposes of carrying out Subsection D,
an issuer of a Medicare supplement policy or certificate may request only the
minimum amount of information necessary to accomplish the intended
purpose.
F. Notwithstanding
Subsection C, an issuer of a Medicare supplement policy may request, but not
require, that an individual or a family member of such individual undergo a
genetic test if each of the following conditions is met:
(1) The request is made pursuant to research
that complies with part 46 of title 45, Code of Federal Regulations, or
equivalent Federal regulations, and any applicable state or local law or
regulations for the protection of human subjects in research.
(2) The issuer clearly indicates to each
individual, or in the case of a minor child, to the legal guardian of such
child, to whom the request is made that:
a.
Compliance with the request is voluntary; and
b. Non-compliance will have no effect on
enrollment status or premium or contribution amounts.
(3) No genetic information collected or
acquired under this subsection shall be used for underwriting, determination of
eligibility to enroll or maintain enrollment status, premium rates, or the
issuance, renewal, or replacement of a policy or certificate.
(4) The issuer notifies the Secretary in
writing that the issuer is conducting activities pursuant to the exception
provided for under this subsection, including a description of the activities
conducted.
(5) The issuer complies
with such other conditions as the Secretary may by regulation require for
activities conducted under this subsection.
G. An issuer of a Medicare supplement policy
or certificate shall not request, require, or purchase genetic information for
underwriting purposes.
H. An issuer
of a Medicare supplement policy or certificate shall not request, require, or
purchase genetic information with respect to any individual prior to such
individual's enrollment under the policy in connection with such
enrollment.
I. If an issuer of a
Medicare supplement policy or certificate obtains genetic information
incidental to the requesting, requiring, or purchasing of other information
concerning any individual, the incidental acquisition of genetic information
shall not be considered a violation of Subsection H if the underlying request,
requirement, or purchase of information is not in violation of Subsection
G.
J. For the purposes of this
section only:
(1) "Issuer of a Medicare
supplement policy or certificate" includes a third-party administrator, or
other person acting for or on behalf of the issuer.
(2) "Family member" means, with respect to an
individual, any other individual who is a first-degree, second-degree,
third-degree, or fourth-degree relative of such individual.
(3) "Genetic information" means, with respect
to any individual, information about such individual's genetic tests, the
genetic tests of family members of such individual, and the manifestation of a
disease or disorder in family members of such individual. Such term includes,
with respect to any individual, any request for, or receipt of, genetic
services, or participation in clinical research which includes genetic
services, by such individual or any family member of such individual. Any
reference to genetic information concerning an individual or family member of
an individual who is a pregnant woman, includes genetic information of any
fetus carried by such pregnant woman, or with respect to an individual or
family member utilizing reproductive technology, includes genetic information
of any embryo legally held by an individual or family member. The term "genetic
information" does not include information about the sex or age of any
individual.
(4) "Genetic services"
means a genetic test, genetic counseling (including obtaining, interpreting, or
assessing genetic information), or genetic education.
(5) "Genetic test" means an analysis of human
DNA, RNA, chromosomes, proteins, or metabolites, that detect genotypes,
mutations, or chromosomal changes. The term "genetic test" does not mean 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 could reasonably be detected by a health care professional with
appropriate training and expertise in the field of medicine involved.
(6) "Underwriting purposes" means,
a. Rules for, or determination of,
eligibility (including enrollment and continued eligibility) for benefits under
the policy;
b. The computation of
premium or contribution amounts under the policy;
c. The application of any pre-existing
condition exclusion under the policy; and
d. Other activities related to the creation,
renewal, or replacement of a contract of health insurance or health
benefits.
Notes
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