Medical Device Daily Executive Editor

SAN FRANCISCO – Those involved with med-tech on the manufacturer side, or the side of those who invest in the space, know that healthcare providers and payers evaluate new technology before making their decisions on whether to use it.

What they may not know is how those evaluations are made.

Andrew Robertson, MD, former chief medical officer for Community Regional Medical Center in California, shed some light on that process during a session at last week's Frost & Sullivan Medical Technologies Executive MindXchange at the Grand Hyatt hotel.

Robertson, who now operates as a consultant in the healthcare sector, serves as a co-sponsor representative of the California Hospital Association (Sacramento) at the California Technology Assessment Forum for Medical Technologies (CTAF; San Francisco).

Terming the overall question of technology assessment “a hornet's nest,“ he cited the value of the CTAF – an effort spurred by the Blue Shield of California Foundation – in “helping support the 'evidence' part of evidence-based medicine.“

Robertson said that in his previous role, he found that new medical technology being promoted to hospital buyers was accepted only 27% of the time.

“That's a lousy percentage,“ he said, noting that the goal of the CTAF is to change the whole process of getting new technology into the hands of those providing care from one dominated by marketing and sales efforts to one where objective, unbiased assessment of those technologies can take place.

“The marketing and sales processes are largely dysfunctional,“ Robertson said. “The issue now is, 'What is the assessment process?'“

He said CTAF has five technology criteria that largely follow the Cooke criteria, which he characterized as “the most blunt assessment criteria“ used today.

Robertson said that as a result of such “blunt assessment“ criteria being used, “I predict that more good, effective technology will be sold and fewer less-effective technologies will be sold.“

He noted that CTAF meets at least three times a year, sometimes more, and uses the review criteria to assess the safety and efficacy of emerging devices therapies and diagnostic tests.

Robertson said the group's agenda includes both assessment of emerging trends and actual requests of use of new technologies as put forward by practicing physicians.

Physician experts assess all relevant peer-reviewed literature on the topic, supplemented by expert opinion from specialty physicians, medical societies and other organizations that review technology, such as the Centers for Medicare & Medicaid Services (CMS).

He cited the growing emphasis by providers and payers on evidence-based medicine (EBM), saying, for example, that CMS “is getting involved with conditional approvals“ for reimbursement, the permanence of those approvals being dependent on postmarket findings as to efficacy of treatment.

Robertson said EBM “is more effectively impacting capital spending by providers.“

He added that the changing nature of technology assessment in the U.S. in many ways reflects successes such as that realized under the National Institute for Clinical Excellence (NICE) structure in the UK. “The NICE process is being evaluated here,“ he said.

Robertson said the increasing emphasis by the FDA on postmarket trials and registries means that outcomes reached via use of new technologies “are being held to higher standards of statistical rigor.“

To the med-tech companies in the audience, he said, “Your involvement is going to be key. If you have rigorous postmarket trials, there will be a clearer path to acceptance of your technology.“ Such studies “raise the bar,“ he said.

He said CTAF “currently has about 110 devices in the hopper, awaiting evidence.“

Robertson hailed the CTAF effort as “a forum that is going to continue to evolve.“

He said that while CTAF “does not set reimbursement,“ it “may become a standard against which payers measure [reimbursement levels].“

Noting that the assessment program is little known beyond the provider and manufacturer communities, Robertson said “the press has not bothered to come around much of late.“

Well, doctor, here's a start.