Today’s healthcare executive faces the most increasingly complex regulatory environment seen since the enactment of Medicare in 1965. In addition to federal standards, they must comply with state regulations and the regulations for each country in which their company conducts business. Considering the scope and range of the fast changing healthcare regulatory environment – is it any wonder healthcare executives lose sleep over regulatory compliance?
In the past year much of the healthcare industry’s discussion of regulation has focused on the enactment of the Patient Protection & Affordable Care Act (ACA), which contains ninety-one distinct provisions. But that’s only one of numerous changing regulatory mandates.
To operate in the United States alone, industry professionals must address policies and requirements from a multitude of state regulatory agencies as well as federal agencies such as:
- Centers for Disease Control and Prevention (CDC),
- Drug Enforcement Administration (DEA),
- Environmental Protection Agency (EPA),
- Food & Drug Administration (FDA), and
- Department of Human Health and Services (HHS).
Between 1990 and 2011, the FDA alone issued 852 Guidance Documents – each carrying the same impact as a general statute.
Overwhelmed yet? Here’s one place to start.
On average a company’s supply chain influences seventy-five percent of financial performance. A best in class supply chain can facilitate regulatory compliance across information systems, distribution, and transportation; and facilitate expansion into new markets with minimal capital investment. An inefficient supply chain can negate millions of dollars of investment in R&D for a new product introduction and create openings for a competitor to claim market space with alternative products.
Given the complexity of today’s regulatory environment, it becomes vitally important for healthcare executives to be able to leverage partnerships with experts across a range of functions who can help with the heavy lifting required to navigate the maze of regulatory compliance in a fast changing environment.
What keeps you up at night? Let us know in the comments.
|Tags:||healthcare, regulation, supply chain|