Medical Device Daily Washington Editor

WASHINGTON – Barry Straube, MD, the recently named acting chief medical officer of the Centers for Medicare & Medicaid Services (CMS; Baltimore), says he is bringing his “West Coast, open-minded approach” to his work at the agency.

Participating in a panel discussion at this week’s annual meeting of the Medical Device Manufacturers Association (MDMA; Washington), Straube told the audience that he planned to “stir things up a little bit” at the agency, regardless of whether his position is a short- or long-term appointment.

In his new role, he also serves as acting director of the Office of Clinical Standards and Quality. He most recently served as chief medical officer of the CMS region in the western U.S., based in San Francisco.

Straube replaces Sean Tunis, MD, who was placed on administrative leave last month following allegations that he falsified continuing medical education documentation. Tunis will remain on leave until the charges are resolved, CMS said at the time.

“I think that given my background in critical care neph-rology and transplantation, I have a perspective in the world that you all live in, one that perhaps many of the folks at CMS perhaps don’t have,” Straube told the device audience. “I have instructed the folks in my office to be more open than ever and to work as collaborators with industry.”

He said that when he first started with CMS four years ago, he was “na ve” about the complexities of the agency, especially in the area of coverage decisions.

With more than 76 million beneficiaries, and more than $500 billion spent on all agency programs last year, the agency’s actions often can seem enigmatic, Straube acknowledged to meeting attendees.

One of the more notable changes in the agency’s philosophy is a culture shift from one of only a payer to that of a public health agency, driven by CMS administrator Mark McClellan, MD, he said.

“We can use the power and authority of the agency to try and effect change in the U.S. healthcare system across all systems and payers,” Straube said.

The agency’s move toward a more “transparent and predictable” process in releasing its national coverage decisions (NCDs), is another area of transformation he identified.

Another is health information technology promotion and adoption.

“We cannot do quality improvement in the country at the level that we need to unless we have implementation of health information technology systems throughout the healthcare industry,” Straube said.

Other ongoing demonstration projects include CMS pay-for-performance initiatives and coverage with evidence development (CED), which has generated some controversy for the agency.

One of the most recent CED decisions from CMS – the move to expand coverage of implantable cardioverter defibrillators – directly impacted the device sector.

CMS says this approach allows it to provide beneficiaries with “faster and broader access to an item or service,” while at the same time enabling access to new technologies while gathering data on the beneficiary population at the same time. The data can then be used to support a wide range of initiatives inside and outside of CMS.

Straube said direct input from the device sector would be required, going forward, to help the agency “get up to speed” with rapidly changing technology.

“One of our biggest faults has been the predictability of our decisions. We’ve done a lot of work on transparency, now we have to work on predictability,” he said. “Come to us. Ask some questions, make presentations to tell us what is coming up the pipeline so we know what we may need to consider going forward.”

Coverage with evidence development will allow CMS to make earlier coverage decisions, Straube said, “while allowing safety and overall benefits and better definition of target populations, especially for device services.”