(a) This section
applies to all Medicare supplement policies with policy years beginning on or
after May 21, 2009.
(b) For
purposes of this section, the following words and terms have the following
meanings, unless the context clearly indicates otherwise:
Issuer-The issuer of a Medicare
supplement policy or certificate as defined in §
89.772. This term includes a third
party administrator, or other person acting for or on behalf of the
issuer.
Family member-A first-degree,
second-degree, third-degree or fourth-degree relative of an individual.
Genetic counseling-Obtaining,
interpreting, or assessing genetic information.
Genetic information-Except for the sex or
age of an individual, information regarding:
(i) Genetic tests of an individual or
individual's family member.
(ii)
The manifestation of a disease or disorder in an individual's family
member.
(iii) An individual's
request for, or receipt of, genetic services.
(iv) Participation in clinical research
involving genetic services by an individual or an individual's family
member.
(v) When an individual or
family member is a pregnant woman, any reference to information of any fetus
carried by the woman.
(vi)
Information of any embryo legally held by an individual or family member
utilizing reproductive technology.
Genetic
services-A genetic test, genetic counseling or genetic
education.
Genetic test-An analysis of
human DNA, RNA, chromosomes, proteins or metabolites, that detect genotypes,
mutations or chromosomal changes. The term does not include an analysis of
proteins or metabolites that does not detect genotypes, mutations or
chromosomal changes or an analysis of proteins or metabolites directly related
to a manifested disease, disorder, or pathological condition that may
reasonably be detected by a health care professional with appropriate training
and expertise in the field of medicine involved.
(c) An issuer of a Medicare supplement policy
or certificate may not:
(1) Use an
individual's genetic information to deny or condition the issuance or
effectiveness of a policy or certificate to that individual, including the
imposition of an exclusion of benefits based on a preexisting
condition.
(2) Use an individual's
genetic information to discriminate in the pricing of the policy or
certificate, including the adjustment of premium rates.
(3) Request or require an individual or an
individual's family member to undergo a genetic test, except the issuer may:
(i) Obtain and use the results of a genetic
test in making a determination regarding payment, as defined for the purposes
of applying regulations promulgated under Title XI Part C of the Social
Security Act (42 U.S.C.A.
§§
1320d-1320d-9) and section 264
of the Health Insurance Portability and Accountability Act of 1996
(42 U.S.C.A. §
1320d-2 note 2), consistent with paragraphs
(1) and (2) if the issuer requests only the minimum amount of information
necessary to accomplish the intended purpose.
(ii) Request, but not require, an individual
or individual's family member to undergo a genetic test if the following
conditions are met:
(A) The request is made
under research that complies with 45 CFR Part
46 (relating to protection of
human subjects), or equivalent Federal regulations, and any applicable State or
local law or regulations for the protection of human subjects in
research.
(B) The issuer clearly
indicates to the individual, or the legal guardian of a minor child, to whom
the request is made, that compliance with the request is voluntary and that
noncompliance will have no effect on enrollment status or premium or
contribution amounts.
(C) The
issuer does not use genetic information collected or acquired under this clause
for underwriting, determination of eligibility to enroll or maintain enrollment
status, premium rates, or the issuance, renewal, or replacement of a policy or
certificate.
(D) The issuer
notifies the HHS Secretary in writing that the issuer is conducting activities
under the exception provided for under this subsection, including a description
of the activities conducted.
(E)
The issuer complies with other conditions as the HHS Secretary may, by
regulation, require for activities conducted under this subparagraph.
(4) Request, require, or
purchase genetic information for underwriting purposes to:
(i) Determine enrollment, eligibility or
continued eligibility for benefits under a policy.
(ii) Compute premium contribution amounts
under a policy.
(iii) Apply any
preexisting condition exclusion under a policy.
(iv) Conduct any activity related to the
creation, renewal or replacement of a contract of health insurance or health
benefits.
(5) Request,
require or purchase an individual's genetic information prior to that
individual's enrollment under the policy in connection with enrollment. If an
issuer obtains genetic information incidental to the requesting, requiring, or
purchasing of other information concerning an individual, the request,
requirement, or purchase is not a violation of this paragraph if the request,
requirement or purpose does not violate paragraph (4).
(d) Nothing in subsection (c)(1) or (2) 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.
(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 a group policy; provided that the
manifestation of a disease or disorder in one individual may not also be used
as genetic information about other group members and to further increase the
premium for the group.