In general, the proposed regulations are in response to the provisions in GINA requiring HHS to revise the HIPAA privacy regulations to clarify that genetic information is protected health information (“PHI”) and to prohibit group health plans, health insurance issuers and issuers of Medicare supplemental policies from using or disclosing genetic information for underwriting purposes. Health plans must comply with these modifications no later than 180 days after final regulations are published.
The proposed regulations to the HIPAA privacy regulations –
The proposed regulations would extend GINA’s prohibition on using and disclosing genetic information for underwriting purposes to all health plans that are subject to the HIPAA privacy regulations, not solely to those plans GINA explicitly requires be subject to the prohibition. For example, the prohibition would be extended to long-term care policies, certain public benefit programs, such as Medicare and Medicaid, military health care programs, and limited scope dental and vision benefits so that all provisions would apply uniformly to all health plans covered by the HIPAA privacy regulations.
Prohibition with Respect to Underwriting Purposes
The proposed regulations clarify that genetic information cannot be used or disclosed for underwriting purposes, notwithstanding any other provisions in the HIPAA privacy regulations to the contrary (for example, even if an individual has signed an authorization for such use or disclosure). Examples of violations of this requirement provided by HHS are –
Notice of Privacy Practices
HHS has determined that individuals should be specifically notified that health plans may not use or disclose their genetic information for underwriting purposes. Therefore, if a health plan does use or disclose PHI for underwriting, it must revise its notice to include a statement making this prohibition clear. (Note that because of the expansive definition of PHI in the HIPAA privacy regulations, substantially all health plans will use PHI for underwriting, thereby becoming subject to this revised notice rule.) The general rule is that a notice must be distributed within 60 days of a material change. Due to the additional cost of this disclosure, and the fact that additional changes to the notice may be required under the provisions of HITECH in the near future, HHS is considering various options. These options include replacing the 60-day rule with a requirement that notices be distributed in the next annual mailing after a material revision (such as during annual enrollment); extending the 60-day rule solely for notifying individuals of the underwriting rule; retaining the 60-day requirement but allowing the Secretary to waive the timeframe in certain situations; or making no change to the requirement. Because the GINA privacy provisions were effective May 20, 2009, many health plans have already updated their notices on this issue.
Impact on Other Documents
Based on the proposed regulations, other documents should also be updated to reflect the new GINA provisions, including the health plan’s policies and procedures. Depending on the services that are provided by a business associate and the language of existing business associate agreements, applicable business associate agreements may also need to be updated. Last, health plan sponsors should also consider whether adding protective language in their health plan documents is also appropriate.
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