An effective healthcare compliance program is an essential component to any medical device company. Compliance and ethics programs support an organization’s business objectives, identifies the boundaries of legal and ethical behavior, and establishes a system to alert management when the organization is getting close to (or crossing) a boundary or approaching an obstacle that prevents the achievement of a business objective.
Lacking an efficient healthcare compliance program puts your organization at risk. Some of the risks involved are: Qui Tam law suits, litigation costs, Congressional scrutiny, increased prosecution, public perception, corporate integrity, proper industry relationships with physicians, and conflicts of interest. Additionally, in Fiscal year 2013, the federal government recovered $4.3 billion in fraudulent healthcare payments, the largest amount ever collected in a single year. But with an effective healthcare compliance program in place, internal policies and procedures can prevent issues from arising.
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has the expertise and resources to assist your organization in everything from development and implementation of new healthcare compliance programs, to evaluation, adaptation and alteration of existing healthcare compliance programs, and everything in between. Our extensive service offerings, objective perspectives, and industry insight allows us to provide a variety of services divided into the following categories:
To speak with a regulatory consultant, please call 202.552.5800