Originally Published MDDI April 2004

EDITOR'S PAGE

 

New mandates could mean quicker CMS acceptance. While waiting for them to kick in, though, consider some practical tips from a CMS and industry insider.

As industry veterans know all too well, the Centers for Medicare & Medicaid Services (CMS), like FDA, has a great deal of control over which products succeed in the marketplace. But the two agencies are unlike in many other ways. Understanding how CMS differs is a key to dealing effectively with that agency.

As the former director of the Center for Medicare Management at CMS, Thomas Grissom knows Medicare inside out. A CMS director until recently, Grissom was responsible for developing reimbursement policies and regulations for the fee-for-service Medicare program. Now with Boston Scientific, he shared some practical advice with executives at the AdvaMed annual meeting in Phoenix last March. 

“CMS buys services,” he said. “It looks at what is reasonable and necessary, whereas FDA looks at safety and efficacy.” The CMS process, he said, involves the decidedly arduous “prospect of benefit determination, coding, payment, and system change.”

He emphasized that CMS is intrinsically slow to change. The structure of CMS was reorganized in 1997 into what he called a “matrixed” organization. By and large, he said, it “still works in ‘silos,' using uncodified processes.” Its management practices are legislated rather than logical, and it “is seriously underinvested in systems.”

To deal with this complicated and unfamiliar bureaucracy, Grissom offered several strategies that can help device makers overcome the system's inherent drawbacks.

• Do not separate R&D from reimbursement.
• Focus on substantial clinical improvements.
• Don't assume FDA and CMS communicate.
• Give CMS options to choose from.
• Follow the process—you will “never win just based on facts.”
• If CMS asks for information, provide it.

In addition, some good news may be on the horizon. Grissom pointed to three sections of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that are specifically designed to enable CMS to expedite the acceptance of new technology: 

• Section 731, Improvements in national and local coverage determination process to respond to changes in technology. 
• Section 940A, Mediation process for local coverage determinations. 
• Section 942, Improvement in oversight of technology and coverage. 

Grissom stressed, however, that it is critical that manufacturers learn about these rules and use them to their advantage. 

“I assume we all know why we're regulated,” he said. “There is a public interest and a political interest in the safety of medical devices.” More steps, he continued, are needed to help doctors and patients get access to these innovations. As one example, he cited postapproval studies to develop protocols.

Grissom pointed out that it will take a lot of external pressure for CMS to implement new procedures. That pressure, he said, must come from manufacturers, among others.

“If left to its own devices, CMS won't make it work,” he said. For manufacturers, however, it must work. Timely acceptance by CMS is often key to a product's success in the marketplace.

The Editors

Copyright ©2004 Medical Device & Diagnostic Industry