HIPAA Final Rule: Genetic Information Nondiscrimination Act: Manifestation or Manifested

February 19, 2013.  Today, we finish examination of modifications of HIPAA Privacy under the Genetic Information Nondiscrimination Act (GINA), by focusing on the definition: manifestation or manifested. The modifications of HIPAA Privacy are in the Final Rule:  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules, which was published in the Federal Register on January 25, 2013.  The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013.

We presented in the posting of February 15 manifestation or manifested as one of the new definitions related to GINA cited in the Final Rule, and repeat it here:

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. For purposes of this subchapter, a disease, disorder, or pathological condition is not manifested if the diagnosis is based principally on genetic information.  [78 Federal Register 5689]

GINA did not define manifestation or manifested, but the Department did in the Final Rule “given the importance of the term.”  [78 Federal Register 5663]

The Final Rule discusses the concept of manifestation or manifested:

“Although not separately defined by GINA, the terms manifestation or manifested are used in GINA in three important contexts:

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.

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.

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 disorders of an individual enrolled in the plan. [Final Rule Footnote:  ‘We note that the Affordable Care Act, enacted on March 23, 2010, includes a provision effective for plan years beginning on or after January 1, 2014, that prohibits insurers from discriminating against individuals or charging individuals higher rates based on pre-existing conditions.  See Public Law 111-148’] 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.  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, 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.”  [78 Federal Register 5663]

In contrast to health plans, “[a] health care provider may use or disclose genetic information as it sees fit for treatment of an individual.  If a covered entity, such as an HMO, acts as both a health plan and health care provider, it may use genetic information for purposes of treatment, to determine the medical appropriateness of a benefit, and as otherwise permitted by the Privacy Rule, but may not use such genetic information for underwriting purposes.  Such covered entities, in particular, should ensure that appropriate staff members are trained on the permissible and impermissible uses of genetic information.”  [78 Federal Register 5667]

We recommend that any covered entity that creates, receives, or maintains genetic information, as defined at 45 CFR 60.103, 78 Federal Register 5688-5689, and effective March 26, 2013, carefully read Section VI of the Preamble in the Final Rule:  Modifications to the HIPAA Privacy Rule (pages 5658-5669).

Tomorrow, we begin to examine Final Rule modifications related to enforcement.

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