![]() ![]() Under the proposed definition, the presence of a genetic variant alone would not constitute the diagnosis of a disease even in cases where it is certain the individual possessing the genetic variant will eventually develop the disease, such as with Huntington’s disease.Ī few commenters expressed support for adopting the proposed definition of “manifestation or manifested” because it would provide clarity to the rule and the scope of the underwriting prohibition. However, an individual may obtain a positive test that shows the genetic variant for Huntington’s disease decades before any clinical symptoms appear. In other cases, the presence of a genetic variant indicates that the individual will eventually develop the disease, such as is the case with Huntington’s disease. In some cases, an individual may have a genetic variant for a disease and yet never develop the disease. This clarification was included due to the fact that variants of genes associated with diseases have varying degrees of predictive power for later development of the disease. The proposed definition also provided that a disease, disorder, or pathological condition is not manifested if the diagnosis is based principally on genetic information. Although GINA does not define the term, it is clear from the statutory definition of “genetic test” that a manifested disease or disorder is one “that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.”Īccordingly, the proposed rule defined the term “manifestation or manifested” to mean, with respect to a disease, disorder, or pathological condition, that an individual has been or could reasonably be diagnosed with the disease, disorder, or pathological condition by a health care professional with appropriate training and expertise in the field of medicine involved. Given the importance of the term “manifested” or “manifestation,” the Department proposed to define the term. ![]() However, under GINA, the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other individuals and to further increase premiums or contribution amounts. Similarly, for the individual health insurance market, GINA clarifies that it does not prohibit a health plan from establishing rules for eligibility for an individual to enroll in coverage or from adjusting premium or contribution amounts for an individual based on the manifestation of a disease or disorder in that individual or in a family member of such individual where such family member is covered under the individual’s policy. However, GINA provides that, 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 plan. Third, GINA uses the term “manifestation” to clarify that nothing in Title I of GINA should be construed to limit the ability of a health plan to adjust premiums or contribution amounts for a group health plan based on the manifestation of a disease or disorder of an individual enrolled in the plan. Second, GINA uses the term “manifested” to exclude from the definition of “genetic test” those tests that analyze a physical malady rather than genetic makeup by excluding from the definition analyses of proteins or metabolites that are directly related to a manifested disease, disorder, or pathological condition. First, GINA uses the term “manifestation” to incorporate “family medical history” into the definition of “genetic information” by stating that “genetic information” includes, with respect to an individual, the manifestation of a disease or disorder in family members of such individual. General Provisions: Definitions - Manifestation or Manifested - § 160.103Īlthough not separately defined by GINA, the terms “manifestation” or “manifested” are used in GINA in three important contexts. ![]() HHS Description and Commentary From the January 2013 Amendments For purposes of this subchapter, a disease, disorder, or pathological condition is not manifested if the diagnosis is based principally on genetic information. Manifestation or manifested means, with respect to a disease, disorder, or pathological condition, that an individual has been or could reasonably be diagnosed with the disease, disorder, or pathological condition by a health care professional with appropriate training and expertise in the field of medicine involved. General Provisions: Definitions - Manifestation or Manifested- § 160.103 HHS Regulations as Added by the January 2013 Amendments HIPAA Regulations: General Provisions: Definitions: Manifestation or Manifested - § 160.103 ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |