HHS tightens conflict of interest regulation
While healthcare organizations have been preoccupied with EHR meaningful use, ICD-10 and HIPAA 5010, a lesser-known set of regulations that could have a dramatic effect on research institutions, and which will also require technological solutions, was finalized this year.
On Aug. 23, 2011, the Department of Health and Human Services published its final rule on financial conflicts of interest (FCOI). The regulations are a significant update on initial rules published in 1995, and they demand greater transparency and accountability for research institutions that receive Public Health Service (PHS) funds from the National Institutes of Health (NIH).
High-tech hospitals and practices may be able to leverage their infrastructure to comply with the final rule, but organizations that still collect and track financial disclosure information on paper could have a significant challenge ahead. The compliance deadline is August 24, 2012, so institutions that currently have FCOI compliance on the back burner will need to start developing new disclosure processes immediately.
Below are five steps to help organizations comply with the FCOI final rule and suggestions about how to incorporate technology to make the process easier.
1. Involve senior leadership: Just as with EHR meaningful use and ICD-10, complying with the FCOI final rule should be a top priority for an organization’s senior leadership. Updating or creating a database that tracks physicians’ and other research investigators’ remuneration from pharmaceutical and medical device companies - as well as other financial interests that might affect their decision-making - will require staffing time and money. Leadership awareness and endorsement of the initiative will help secure those resources. Leaders can learn more about the final rule from this NIH Webinar that was held on November 30: http://grants.nih.gov/grants/policy/coi/fcoi_webinar_20111130.htm.
2. Improve data gathering capability: The new regulations define “significant financial interest” (SFI) as any industry compensation that exceeds $5,000 over 12 months, down from the current $10,000 limit, any equity participation in a non-public company, and certain intellectual property rights. Disclosure is required if these payments or interests are "reasonably related" to institutional responsibilities. A significant financial interest can be that of the investigator, his or her spouse or dependent children. Ideally, organizations should be gathering financial disclosures at least annually through an automated on-line questionnaire that feeds into a centralized database. If disclosures are still collected on paper, then that information should be entered into a relational database that can be updated on a transactional basis as physicians and researchers join the organization or receive new industry compensation, and as institutions apply for PHS funding.
3. Create management plan templates: One of the most significant new aspects of the final rule calls for institutions to create management plans for mitigating FCOI among research investigators. Some of those management plan components include: