AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING TO MEDIGAP.

SEC. 104. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SECURITY ACT RELATING TO MEDIGAP.(a) Nondiscrimination.—Section 1882(s)(2) of the Social Security Act (42 U.S.C. 1395ss(s)(2)) is amended by adding at the end the following:“(E) An issuer of a medicare supplemental policy shall not deny or condition the issuance or effectiveness of the policy (including the imposition of any exclusion of benefits under the policy based on a pre-existing condition) and shall not discriminate in the pricing of the policy (including the adjustment of premium rates) of an individual on the basis of the genetic information with respect to such individual.“(F) Rule of construction.—Nothing in subparagraph (E) or in subparagraphs (A) or (B) of subsection (x)(2) shall be construed to limit the ability of an issuer of a medicare supplemental policy from, to the extent otherwise permitted under this title—“(i) denying or conditioning the issuance or effectiveness of the policy or increasing the premium for an employer based on the manifestation of a disease or disorder of an individual who is covered under the policy; or“(ii) increasing the premium for any policy issued to an individual based on the manifestation of a disease 122 STAT. 900 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 and to further increase the premium for the employer).”.(b) Limitations on Genetic Testing and Genetic Information.—(1) In general.—Section 1882 of the Social Security Act (42 U.S.C. 1395ss) is amended by adding at the end the following:“(x) Limitations on Genetic Testing and Information.—“(1) Genetic testing.—“(A) Limitation on requesting or requiring genetic testing.—An issuer of a medicare supplemental policy shall not request or require an individual or a family member of such individual to undergo a genetic test.“(B) Rule of construction.—Subparagraph (A) shall not be construed to limit the authority of a health care professional who is providing health care services to an individual to request that such individual undergo a genetic test.“(C) Rule of construction regarding payment.—“(i) In general.—Nothing in subparagraph (A) shall be construed to preclude an issuer of a medicare supplemental policy from obtaining and using the results of a genetic test in making a determination regarding payment (as such term is defined for the purposes of applying the regulations promulgated by the Secretary 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) consistent with subsection (s)(2)(E).“(ii) Limitation.—For purposes of clause (i), an issuer of a medicare supplemental policy may request only the minimum amount of information necessary to accomplish the intended purpose.“(D) Research exception.—Notwithstanding subparagraph (A), an issuer of a medicare supplemental 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:“(i) 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.“(ii) 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—“(I) compliance with the request is voluntary; and“(II) non-compliance will have no effect on enrollment status or premium or contribution amounts.122 STAT. 901“(iii) No genetic information collected or acquired under this subparagraph shall be used for underwriting, determination of eligibility to enroll or maintain enrollment status, premium rating, or the creation, renewal, or replacement of a plan, contract, or coverage for health insurance or health benefits.“(iv) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to the exception provided for under this subparagraph, including a description of the activities conducted.“(v) The issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this subparagraph.“(2) Prohibition on collection of genetic information.—“(A) In general.—An issuer of a medicare supplemental policy shall not request, require, or purchase genetic information for underwriting purposes (as defined in paragraph (3)).“(B) Prohibition on collection of genetic information prior to enrollment.—An issuer of a medicare supplemental policy 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.“(C) Incidental collection.—If an issuer of a medicare supplemental policy obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation of subparagraph (B) if such request, requirement, or purchase is not in violation of subparagraph (A).“(3) Definitions.—In this subsection:“(A) Family member.—The term ‘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.“(B) Genetic information.—“(i) In general.—The term ‘genetic information’ means, with respect to any individual, information about—“(I) such individual’s genetic tests,“(II) the genetic tests of family members of such individual, and“(III) subject to clause (iv), the manifestation of a disease or disorder in family members of such individual.“(ii) Inclusion of genetic services and participation in genetic research.—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.“(iii) Exclusions.—The term ‘genetic information’ shall not include information about the sex or age of any individual.“(C) Genetic test.—122 STAT. 902“(i) In general.—The term ‘genetic test’ means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.“(ii) Exceptions.—The term ‘genetic test’ does not mean—“(I) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or“(II) 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.“(D) Genetic services.—The term ‘genetic services’ means—“(i) a genetic test;“(ii) genetic counseling (including obtaining, interpreting, or assessing genetic information); or“(iii) genetic education.“(E) Underwriting purposes.—The term ‘underwriting purposes’ means, with respect to a medicare supplemental policy—“(i) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the policy;“(ii) the computation of premium or contribution amounts under the policy;“(iii) the application of any pre-existing condition exclusion under the policy; and“(iv) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.“(F) Issuer of a medicare supplemental policy.—The term ‘issuer of a medicare supplemental policy’ includes a third-party administrator or other person acting for or on behalf of such issuer.”.(2) Application to genetic information of a fetus or embryo.—Section 1882(x) of such Act, as added by paragraph (1), is further amended by adding at the end the following:“(4) Genetic information of a fetus or embryo.—Any reference in this section to genetic information concerning an individual or family member of an individual shall—“(A) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic information of any fetus carried by such pregnant woman; and“(B) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.”.(3) Conforming amendment.—Section 1882(o) of the Social Security Act (42 U.S.C. 1395ss(o)) is amended by adding at the end the following:“(4) The issuer of the medicare supplemental policy complies with subsection (s)(2)(E) and subsection (x).”.122 STAT. 903(c) Effective Date.—The amendments made by this section shall apply with respect to an issuer of a medicare supplemental policy for policy years beginning on or after the date that is 1 year after the date of enactment of this Act.(d) Transition Provisions.—(1) In general.—If the Secretary of Health and Human Services identifies a State as requiring a change to its statutes or regulations to conform its regulatory program to the changes made by this section, the State regulatory program shall not be considered to be out of compliance with the requirements of section 1882 of the Social Security Act due solely to failure to make such change until the date specified in paragraph (4).(2) NAIC standards.—If, not later than October 31, 2008, the National Association of Insurance Commissioners (in this subsection referred to as the “NAIC”) modifies its NAIC Model Regulation relating to section 1882 of the Social Security Act (referred to in such section as the 1991 NAIC Model Regulation, as subsequently modified) to conform to the amendments made by this section, such revised regulation incorporating the modifications shall be considered to be the applicable NAIC model regulation (including the revised NAIC model regulation and the 1991 NAIC Model Regulation) for the purposes of such section.(3) Secretary standards.—If the NAIC does not make the modifications described in paragraph (2) within the period specified in such paragraph, the Secretary of Health and Human Services shall, not later than July 1, 2009, make the modifications described in such paragraph and such revised regulation incorporating the modifications shall be considered to be the appropriate regulation for the purposes of such section.(4) Date specified.—(A) In general.—Subject to subparagraph (B), the date specified in this paragraph for a State is the earlier of—(i) the date the State changes its statutes or regulations to conform its regulatory program to the changes made by this section, or(ii) July 1, 2009.(B) Additional legislative action required.—In the case of a State which the Secretary identifies as—(i) requiring State legislation (other than legislation appropriating funds) to conform its regulatory program to the changes made in this section, but(ii) having a legislature which is not scheduled to meet in 2009 in a legislative session in which such legislation may be considered, the date specified in this paragraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after July 1, 2009. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.