This is the fourth in our series on provisions of the Department of Health and Human Services (HHS) proposed rule implementing the HITECH Act that, if included in the final rule, are likely to have the greatest impact on the business operations of pharmaceutical and other life sciences companies.  We previously covered HHS’s proposed treatment of communications about currently prescribed drugs, remunerated treatment communications, and authorizations for future research.

Today we will address how HHS may relax the current restrictions on “compound authorizations” for research purposes.

Compound Authorizations

HHS is proposing to amend the compound authorization requirements under the HIPAA Privacy Rule, which currently prohibit combining an authorization that conditions treatment, payment, enrollment in a health plan, or eligibility for benefits with an authorization for another purpose for which treatment, payment, enrollment, or eligibility may not be condition.  HHS recognized that the excess paperwork that results from this restriction has been found to be burdensome and potentially confusing to patients, as well as administratively burdensome for clinical researchers.

The proposed rule would permit a covered entity to combine conditioned and unconditioned authorizations for research, so long as the authorization:

  • clearly differentiates between the conditioned and unconditioned components; and
  • provides the individual with an opportunity to opt in to the research activities described in the unconditioned authorization.

Pharmaceutical companies will want to pay close attention to whether this change is included in the final rule.  Like the potential modification to the rules on authorization for future research, this amendment could have a significant impact on the conduct of clinical trials.  Adoption of the proposal holds the potential to alleviate administrative burdens on both clinical trial subjects and researchers and to facilitate more uniformity in the documentation of global trials (since the compound authorization prohibition is unique to the United States).

Tags: Health Privacy, HIPAA, HITECH Act, research
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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

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