Update on CMS's National Coverage Decision on Charite
BY DAVID KRESSEL, SEPTEMBER 22, 2005
As discussed in Barb Peterson's guest blog, the Centers for Medicare and Medicaid Studies (CMS) received a letter from an internist and Professor of Medicine at Washington University, Dr. Richard Deyo, requesting a National Coverage Determination (NCD) of the Charite artificial disc replacement. CMS accepted public comments to decide whether or not to undertake a National Coverage Analysis (NCA) from 8/16/05 - 9/16/05.
We decided to analyze the comments that were published on the web (the letters received by mail were not readily available).
Our observations:
-138 Commenters: 80% were physicians, 10% were patients or their caregivers, 6% were physicians writing as leaders of medical societies, and 4% were device companies.
-Only 3% of respondents said an NCA should be undertaken, all of whom were physicians.
-Physicians usually argued that a) there was not enough data to analyze at this time; and/or b) proper patient selection would rule out the vast majority of Medicare recipients anyway, so there was no reason for CMS to undertake an expensive and time consuming process to make a decision that would have little impact on CMS.
-In addition, many physicians stressed that while an NCD would have little impact on CMS's costs, it would have a hugely negative impact on all disc replacement candidates because private insurers will use CMS's precedent to deny coverage of any disc replacement technology to all patients, regardless of the specific device or patient demographics. This could lead to the demise of the entire spine motion preservation segment.
-Every patient and caregiver who responded had positive things to say about the implant and strongly urged CMS to cover Charite and similar devices. Many mentioned the expense of flying to Europe, and self-paying to receive their implants.
-Device companies had the most interesting response. Of the four who commented, two (including J&J) did not want CMS to undergo an NCD. The other two suggested that CMS make a NCD for Charite, but to exclude newer devices and cervical devices from the decision. Although in the short term, that sounds like a clever ploy to sink Charite until competitors can catch up, in truth, this would almost certainly backfire on the competition and cause payors to refuse to reimburse any disc replacement for any patient.
We think CMS will recognize the paucity of data, will see that more clinical trials are going to finish soon, and will be aware that an NCD would be unfair for the many thousands of patients who should be eligible for total disc arthroplasty. Given the lopsided aggregate opinion of the commenters, we expect CMS to delay the undertaking of a NCA.
