Medical Device Daily Washington Editor

As is typically the case with most government agencies, the Centers for Medicare & Medicaid Services plays a close hand when discussing its future finances, but iffy coverage decisions and the problems experienced by Depuy Spine (Raynham, Massachusetts) with its Charit lumbar replacement disc has done nothing to blunt industry enthusiasm for this sector.

All this comes at a time when the Medicare Coverage Advisory Committee (MCAC) will take another look at spinal fusion. CMS announced in August that the MCAC would convene Nov. 30 to discuss fusion for degenerative disc disease in the lumbar spine as a treatment for pain and “to identify areas where current data is deficient and additional research is necessary.”

The committee will also inquire as to the measures that are the “most informative . . . of clinical outcomes,” as well as indications, complications, adverse events and the “persistence of benefits and harm over time.” The subject of outcomes for the different surgical techniques is also on the agenda.

While the announcement at the CMS web site does not specifically mention procedures other than fusion, it does make note of the fact that “CMS has a significant interest in discussing the evidence for surgical interventions for lumbar degenerative disc disease, with a specific focus on spinal fusion.”

The CMS decision memo on reimbursement for the Charit stated that Medicare administrators are “aware that there are several other disc technologies in FDA investigational device exemption clinical trials.” The memo also states that “when other lumbar spinal disc implants receive approval from the FDA . . . CMS will, by external request or internal direction, open this NCD for reconsideration with a thorough review of the evidence for each new disc implant.”

The memo also says that CMS sees “a tremendous need for additional research on the treatment of degenerative disc disease to include the technology addressed in the NCD — the lumbar artificial disc — and other surgical procedures to include spinal fusion. Therefore, CMS will also convene a Medicare Coverage Advisory Committee at the earliest possible time to address the issue of spinal surgery for degenerative disc disease.”

Firms getting into the spinal disc replacement business may want to double-check the underpinnings of their business plans, however.

The CMS memo found that the “spine surgery rate in the U.S. is the highest in the world, and is approximately five times greater than the rate in England and Scotland.”

Still, Medtronic (Minneapolis) and a host of others are pushing ahead with their plans. Bert Kelly, public relations manager for Medtronic's spinal division, told Medical Device Daily that the company has been interested in this area of device development for a couple of decades.

“Probably the late 90s is when they got serious about it,” Kelly said.

The Prestige had its origins in a British cervical replacement called the Bristol, which was introduced to patients on the other side of the Atlantic in 1991 or so. Kelly said that despite the reputation that the lumbar spine has for being a tougher area to operate in, he is not aware of any conscious decision to try to get a cervical disk out to the market before a lumbar disk.

Medtronic is employing several types of metals to construct their disc replacements. Designs for cervical discs might use any of stainless steel, cobalt chrome and titanium, but none of Medtronic's models for lumbar discs are based on stainless steel. “The weight load is a lot different” for lumbar discs, Kelly pointed out.

Despite the seeming durability of titanium, however, he said, “[w]e don't believe artificial discs will do away with fusion altogether.”

On the subject of the wear of stainless steel components in animal trials that resulted in particulate matter, Kelly said that “[w]e will be going back and looking at this as a condition of approval. There's obviously some wear even in metals, but researchers could not find” the resulting particulate matter.

Kelly said that he was unaware of any evidence of toxicity due to accumulation of the stainless steel particles.

“The only thing that came up [in the human trials] was the incidence of cancer. There were five cases in the investigational arm, but the panel was satisfied that there was no repetitive link” with the device, he said, adding that the occurrence was in line with general rates of cancer.

Just how well the Prestige will do in the senior market remains to be seen, but Kelly did not say that Medtronic was specifically worried about losing prospective implantations due to the aging of the Baby Boom generation.

“When you get to the retirement years, fusion is the standard,” he acknowledged, but insisted that “age in and of itself is not an exclusion factor.” Co-morbidities, such as diabetes and impaired renal function, however, are exclusionary factors and the girth of Baby Boomers at age 65 (and the association between being overweight and diabetes) may have much to say about how well spinal disc replacements sell in the next 30 years.

“We see CMS's decision with the Charit as completely different, but we're not [utterly] depending on CMS for payment,” Kelly insisted “We feel we will get private insurer reimbursement as well as CMS reimbursement.”

One comment in the decision memo likely to ring all too true to firms in the implantable cardioverter defibrillator (ICD) business is that CMS is now keeping a close eye on signs that payers are growing less enamored of their products due to perceptions that ICDs are overused in the U.S. (MDD, May 23, 2006).

Firms getting into the spinal disc replacement business may want to double-check the underpinnings of their business plans, however. One comment in the decision memo will ring all too true to firms in the implantable cardioverter defibrillator (ICD) business, who are now keeping a close eye on signs that payers are growing less enamored of their products due to perceptions that ICDs are overused in the U.S. The CMS memo found that the “spine surgery rate in the U.S. is the highest in the world, and is approximately five times greater than the rate in England and Scotland.”

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