In response to trends observed with the regulatory climate affecting pharmaceutical manufacturers, Alliance Life Sciences Consulting Group (ALSCG) recently published two White Papers entitled Healthcare Reform, Compliance, and Organizational Optimization, and Outsourcing Your Compliance Headache-BPO. These documents define best practices for ensuring compliance while leveraging the associated infrastructure to optimize government programs participation – resulting in curtailed revenue leakage, mitigation of compliance risk, and maximization of profits.

Authored by ALSCG leaders Tony Chen, Associate Director of Government Pricing, and Rob Fellman, Senior Consultant for Government Pricing, the documents outline strategies that help pharmaceutical manufacturers meet the challenges presented by
new Healthcare Reform laws. Additionally, the papers describe how the fundamentals necessary for compliance can be further expanded to optimize their organizations’ strategies, operations, and market intelligence.

"While the Federal government has not issued regulatory or sub-regulatory guidance on all legislative changes, drug manufacturers will need to make and document assumptions regarding government program policy issues — and build out their compliance infrastructures to intelligently and efficiently manage both the risk and the opportunities presented," says Chen. "These proactive steps will decrease the cost and enhance the quality of compliance, with the added potential to gain a competitive
advantage in response to additional efficiencies."

In the Healthcare Reform white paper, ALSCG identifies three core requirements for life sciences manufacturers to develop a robust compliance infrastructure: (1) documentation, (2) validation, and (3) communication of all activities with government programs. ALSCG additionally recommended using the same compliance infrastructure to realize organizational optimization, which is achieved through pricing, contracting, and product positioning.

Using government pricing data requirements to inform business decisions allows for "a clear understanding of business data," allowing drug manufacturers "to improve market intelligence and decision-making capabilities," says Chen, and one option available to
manufacturers to achieve this outcome is through the adoption of an outsourced government compliance model. Due to increased administrative costs in the life sciences industry, manufacturers increasingly are turning to outsourcing their government price calculations and regulatory burden. The ability to outsource the administrative hassle while maintaining an appropriate level of control allows manufacturers to "further realize cost savings, minimize compliance risk, and reduce the burdens on internal systems."