HHS

On October 7, 2009 HHS announced proposed rulemaking to modify the HIPAA privacy rule to comply with Section 105, Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA)  regarding the privacy and confidentiality of genetic information.  The prosed rule is found here HIPAAPRIVACYRULE13343.0.E9-22492. The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically.  Similarly Congress by enacting GINA seeks to protect the genetic privacy of individuals — GINA creates ‘‘a national and uniform basic standard [that] is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.’’ (GINA section 2(5).)

The HIPAA Privacy Rule requires a covered entity (and beginning next year Business Associates) to implement reasonable and appropriate administrative, technical and physical safeguards to protect the privacy of personal health information (PHI).  The HIPAA privacy rule more generally sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.  The Department of Health and Human Services (HHS) proposed to modify provisions of the ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (Privacy Rule), issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The purpose of these proposed modifications is to implement Section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) regarding the privacy and confidentiality of genetic information, as well as to make other less technical changes to the HIPAA Privacy Rule.

GINA specifically prohibits discrimination based on an individual’s genetic information with respect to both health coverage and employment.  It is improper to use an individuals genetic information as basis for determining –

1. health coverage,
2. group premiums,
3. eligibility for insurance,
4. eligibility for employment, and/or
5. premiums for individuals and Medicare insurance policy markets.

HHS proposes to modify the HIPAA Privacy Rule to:

(1)    Explicitly provide that genetic information is health information for purposes of the Rule;
(2)    prohibit health plans from using or disclosing protected health information that is genetic information for underwriting purposes;
(3)    revise the provisions relating to the Notice of Privacy Practices for health plans that perform underwriting;;
(4)    make a number of conforming modifications to definitions and other provisions of the Rule; and
(5)    make technical corrections to update the definition of ‘‘health plan.’

In addition Section 105 of the Genetic Information Nondiscrimination Act of 2008 (“GINA”) provides that a group health plan or health insurer may not use or disclose genetic information for purposes of underwriting. These provisions became effective on May 20, 2009.   On October 7, 2009, the Department of Health and Human Services (“HHS”) issued proposed regulations on how Section 105 will impact the HIPAA privacy regulations and HIPAA covered entities.  Additional regulations issued on October 7, 2009 interpreting other health plan aspects of will be discussed in a subsequent client Alert. ’

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 regulation. T he prohibition would extended 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 regulation.

Comments on the proposed rule will be considered if receive no later than December 7, 2009.  We recommend that a company 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. Finally health plan sponsors may also consider whether adding protective language in their health plan documents is also appropriate.

          

HHS Announces Proposed Rulemaking to modify the HIPAA privacy Rule to Comply with Section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) originally appeared on Law Blog 2.0 on October 15, 2009.