BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.
“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.
The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.
Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.
Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years, mean follow-up was 55 weeks, and the average hospital stay was 1.1 days.
The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”
Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we have not been able to get various factions to decide on how to do the study or whether to participate,” he said.
There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.
But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.
Kevin McGraw, M.D., a Columbus, Ohio radiologist, testified that conservative treatment of vertebral factures—usually bed rest—is not without its risks.
“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”
Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”
Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.
First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”
Journal editors should require disclosure of anterior, middle, and posterior heights, “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”
He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is 4 months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”