Huron Life Sciences Highlights the Top Issues and Trends in Aggregate Spend for 2012

CHICAGO--(EON: Enhanced Online News)--Huron Consulting Group, a leading provider of business consulting services, today released its Huron Life Sciences practice’s top issues and trends for aggregate spend in 2012. During 2011, Life Sciences companies faced increased complexity in their aggregate spend tracking and reporting due not only to the Sunshine Act but also ongoing changes to state disclosure laws, the addition of new Corporate Integrity and Deferred Prosecution Agreements, and institutional requirements compelling disclosure. In 2012, aggregate spend mandates will continue to evolve.

Manny Tzavlakis, managing director, Huron Life Sciences, highlighted four major issues in aggregate spend for 2012.

1. Implementing Healthcare Professional (HCP) and Healthcare Organization (HCO) Relationship Management:

• It will be imperative to understand how and if HCPs’ and HCOs’ reactions to transparency may impact a manufacturer’s existing business model (e.g. decline in professional program-based activities, reluctance of HCPs to serve as clinical trial investigators, etc.).
• Life Sciences companies will need to establish a call center or response mechanism and potentially increase specific resources to handle HCP and HCO spend inquiries and disputes.
• Preparing a Sunshine awareness campaign to educate HCPs and HCOs as well as all corporate functions that interact with HCPs / HCOs is critical; this will enable a consistent, corporate-wide response to HCP/HCO inquiries.

2. Accurate Capture and Disclosure of Clinical Trial Data

• Manufacturers must engage their contract research organizations (CROs) to ensure that those organizations understand and comply with their reporting obligations; companies must modify their contracts with their CROs, establish appropriate service level agreements, and ensure CROs are capturing key data.
• Companies need to create and implement a process for managing complicated delayed-reporting scenarios (e.g. a multi-drug study with approved and unapproved products; a study for an unapproved indication for an approved product).
• Companies should develop a clear plan and guidelines for determining how to track the value of equipment and quantity of free product/drug provided as part of a clinical or medical study.

3. Continuing Reporting Obligations

• Companies may struggle with interpreting detailed requirements for Sunshine reporting, particularly in light of the delay in the release of these requirements.
• Clear internal guidance must be established regarding facilitating company and employee compliance with U.S. Department of Health and Human Services Conflict of Interest Regulations.
• Systems and processes currently in place to meet state reporting requirements may not be scalable to handle the volume of data associated with federal reporting.

4. Impact on Commercial Operations & Clinical Groups

• The public nature of transparency associated with Sunshine regulations may have a dramatic effect on how Life Sciences companies promote products and conduct clinical trials.
• To remain competitive, companies should consider appropriately and compliantly leveraging transparency data for use in business intelligence and analytics.
• The rich data set created by transparency tracking and reporting can be utilized to help targeting and segmentation techniques within sales and marketing and medical and clinical.

If you are interested in speaking with Tzavlakis or another Huron Life Sciences expert about aggregate spend or other issues and trends in the marketplace please contact:

Jennifer Frost Hennagir
312-880-3260
[e-mail]

Jenna Nichols
312-880-5693
[e-mail]

About Huron Life Sciences

Huron Life Sciences serves healthcare providers, academic medical centers, pharmaceutical, medical device, and biotechnology companies and the law firms that support these organizations to define, measure, and achieve financial, operational, and strategic objectives. Learn more at www.huronconsultinggroup.com/lifesciences or follow us on Twitter: @Huron

About Huron Consulting Group

Huron Consulting Group helps clients in diverse industries improve performance, comply with complex regulations, reduce costs, recover from distress, leverage technology, and stimulate growth. The Company teams with its clients to deliver sustainable and measurable results. Huron provides services to a wide variety of both financially sound and distressed organizations, including healthcare organizations, Fortune 500 companies, leading academic institutions, medium-sized businesses, and the law firms that represent these various organizations. Learn more at www.huronconsultinggroup.com.