Medical Device Daily Washington Editor

WASHINGTON — Just as the Centers for Medicare & Medicaid Services is reshaping its reimbursement mechanisms, so too are private payers. And three of the participants at this week’s Medical Device Manufacturers Association (MDMA; Washington) reimbursement conference gave an overview of how that terrain is changing and the potentially controversial role of specialty societies in recommending changes in reimbursement policy.

Judy Rosenbloom, founder and president of JR Associates (Reseda, California), a consultant firm, said of the device industry that it “has formalized a process of reimbursement” but that new trends are shaping reimbursement policy in the private sector.

“We keep going to CMS and getting more accurate payment systems,” with more clarity and transparency, she said, but private payers “are taking control,” and imaging “is a hot button” for them. Private insurers want to see the kind of performance differences seen in pay-for-performance programs, as well as more information on provider qualifications, the latter of which amounts to a form of accreditation. Private payers also want information on medical necessity, “especially in the imaging and cardiology world,” Rosenbloom said.

In an effort to constrain cost increases, health plans are “hiring benefit management companies” to “either establish clinical guidelines or turning to the experts” for help in establishing those guidelines, she said, adding that the experts “are the ones who decide whether a beneficiary gets the device.”

According to Rosenbloom, more stringent coverage policies are becoming more prevalent, “and they’re partnering more with the specialty societies,” such as the American College of Cardiology (Philadelphia). The effort by insurers to develop appropriateness criteria for device reimbursement “is all based on evidence-based guidelines,” and specialty societies are playing an increasingly central role in this field.

Jo Ellen Slurzberg, VP for reimbursement and health policy at holding company Almyra (Boxborough, Massachusetts) and the chair of the MDMA reimbursement task force, said, “we are at a fork in the road in many respects” with regard to relationships with specialty societies.

Slurzberg said, “as payers have moved away from the idea that they are practicing medicine, a lot of the quality standards [developed by specialty societies] and standards of care ... have moved not only from managing things from a quality perspective, [but also] are now linked to coverage.”

And coverage is, in turn, determined in part by the use of current procedural terminology (CPT) codes, which are descriptive terms and identifying codes used to report medical services and procedures. They provide standard terminology to describe medical, surgical, and diagnostic services.

“When we think about those who influence [CPT codes], specialty societies” have a huge role, Slurzberg said, and because “the issue of budget neutrality always creeps in” device makers have to decide how they will ensure that the process of crafting the language in CPT codes is transparent.

Slurzberg recommended that small device makers “should be aware of what your competitors are doing” because “codes could be made at the expense of your product.” In an ideal world, she said, “reimbursement should level the playing field, but sometimes it doesn’t.”

This can be because smaller companies “may not realize the importance” of courting the specialty societies. She said that society web sites will usually list their sponsors, which “will give an idea of” the urgency of engaging a society.

Part of the problem, Slurzberg said, is that medical societies “don’t have transparent processes,” and “there is a lot of money changing hands,” partly in the form of payment for the conduct of clinical trials.

Large companies have the advantage in this game, and because CMS relies on specialty societies, “they need to operate with a lot of sunshine” in order to avoid running afoul of ethical principles.

She said that there may be some momentum in this direction, but offered no specifics.

John McInnes, MD, a partner at the law firm of Arnold & Porter (Washington), said that when talking with clients about getting a device to market, “the strategy will always include communication with specialty societies” to gauge their attitude. Doctors should “always be involved from the beginning as clinical investigators and adopters of technology,” but “there are certain key opinion leaders” to consider as well, he said.

McInnes also noted that while opinion leaders usually lead opinion, that is not always the case. The relationship between leaders and the rank-and-file goes both ways.

So when it comes to specialty societies, McInnes said, “ignore them at your own peril,” noting “their attitudes can make or break a technology’s adoption.” One barrier of interest is that some doctors have “this attitude of a zero-sum game” in that they may believe that more money for devices equals less for doctors. Regardless, “evidence-based medicine is your best argument” when trying to persuade doctors to look at your technology.

“Be very, very aware of competing procedures” that are vying for the same reimbursement niche, which often parallels turf battles within or between societies, McInnes advised. “A lot of times, they’ll avoid taking a position that will make them appear to advocate for a specific device,” he said, but that will not completely halt their willingness to take a public stand.

McInnes recommended that device makers carefully consider the perspectives of all societies.

“Engage them early and often,” he said. “Respect their roles” and device makers will find that “good patient care and strong evidence are always the best arguments.”