May 20, 2013

Vice-President for Healthcare and CMO
Blue Cross and Blue Shield of North Carolina
P.O. Box 2291
Durham, NC 27702

Dear Dr. Bradley:

I am writing you on behalf of International Advocates for Spine Patients (IASP) as well as the patient population of North Carolina. IASP is an organization supported by physicians and patients dedicated to advocacy for high quality, widely accessible and cost effective spine care for patients around the world. I am on the Board of IASP (a sister organization to the International Society for the Advancement of Spine Surgery-ISASS) which was formed in 2011 to complement ISASS’ educational and scientific mission through direct advocacy efforts on the behalf of spine patients. I have spent the last 30 years in NC, generally working in healthcare or related fields. I have been in Charlotte for the last 15 years at Carolina Neurosurgery and Spine Associates and Carolinas Medical Center. I am a past-President of the NC Spine Society, President-elect of the Southern Neurosurgical Society and currently Chief of Neurosurgery at Carolinas Medical Center. I have also been the Principal Investigator on eight FDA Investigational Device Exemption (IDE) trials utilizing artificial discs and have been an author on eight peer-reviewed publications on cervical and lumbar arthroplasty.

I am writing to express serious concerns about numerous factual inaccuracies and omissions on the Blue Cross Blue Shield of North Carolina “Let’s Talk Cost” web site. (http://connect.bcbsnc.com/lets-talk-cost-2013/the-cost-problem/).

This site is troubling for several reasons:

First, although the website touches upon the very real problem of unsustainable increases in the overall cost of healthcare and enumerates several important cost drivers in our system- including unnecessary care, medical errors and inefficient delivery- the content conspicuously avoids describing the substantive value created by many novel devices and procedures. Furthermore, the website seems designed to perpetuate a simplistic and misleading viewpoint that the resources used to routinely improve the lives of patients do nothing other than add burden to an already overtaxed healthcare system. Relatively little attention is focused on industry-related cost drivers including lack of price transparency, excessive administrative costs and premium increases beyond the average annual inflation rate.

Second – and of prime importance to the patients of North Carolina– is the inclusion of frank misinformation about medical technologies specific to spine care. I refer, specifically, to information contained at – http://connect.bcbsnc.com/lets-talk-cost-2013/the-cost-problem/drugs-technology/posts/cause-costly-technology/ – stating that, “in some cases, new technology has proven to be less effective. Cases in point: expensive but ineffective artificial spinal disks.” The only reference provided by the BCBSNC website for this erroneous statement cites a 2008 article from the New York Times (hardly a primary source of credible medical literature).

Perhaps it would be of greater value to cite some of the latest scientific, peer-reviewed literature, including the following:

• There have been exactly 6 US FDA IDE studies of artificial discs (4 cervical and 2 lumbar) whose results have been published in peer-reviewed literature (1, 6, 11, 13, 14, 20). These studies represent Level I scientific data from multi-center, prospective, randomized trials. Not a single study end point has shown artificial discs, or total disc replacement (TDR), to be ‘ineffective’. In fact, the exact opposite was demonstrated. The statistical design of these studies was ‘non-inferiority’ comparing artificial discs to fusion. But, on numerous individual clinical and radiographic end-points, artificial discs were found to be statistically superior. For instance, Mummaneni et al (2007) showed statistically higher neurological success for artificial disc (93%) compared to anterior cervical discectomy and fusion (ACDF) (84%) (13). Heller and associates (2008) showed statistically greater improvement in disability and greater overall success (83% versus 73%) (11). Murrey et al (2009) demonstrated statistically significant fewer secondary surgeries in artificial disc patients (1.8%) compared to ACDF patients (8.5%) (14). Coric et al (2011) showed statistically significant superior overall success rate (85%) compared to ACDF (71%) (6). Interestingly, both Murrey and Coric were the highest enrollers in their respective studies and both included patients exclusively from NC.
• Numerous biomechanical and clinical studies have firmly established that artificial discs maintain motion (4, 5, 16) and place decreased stresses on adjacent levels (3, 15).
• A common early criticism of the artificial disc scientific literature is a relative lack of data with long-term follow-up. Yet, that data is now available. Burkus et al (2010) reported 5 year results which showed statistically higher rate of disability improvement and lower rate of reoperation for artificial discs at 5-year follow-up (2). Delamarter and associates (2010) demonstrated statistically higher rate of pain satisfaction scores at all time points as well as statistically lower rate of index level surgery for TDR at 4 year follow-up (9). Zigler et al (2012), also at 5 year follow-up, showed TDR patients with significantly less neck pain intensity and frequency as well as a lower probability of secondary surgery (19). Garrido (also a NC surgeon) and co-authors (2010) demonstrated continued efficacy of cervical artificial disc at 4-year follow-up (10). Recently, our group at CNSA (2013) published our long-term experience of NC patients which showed, in both TDR and ACDF patients, statistically significant improvement in disability and pain scores by 6 week follow-up which was maintained from 4 to 8 year follow-up (7).
• Recently, Delamarter and Zigler (2012) specifically addressed re-operation rates for cervical artificial disc patients and concluded, “5-year follow-up of a prospective RCT revealed 5-fold difference in re-operation rates when comparing ACDF treated patients (14.5%) to TDR (2.9%). These findings suggest the durability of TDR, as well its potential to slow the rate of adjacent level disease.” (9) Additionally, Upadhyaya and associates (2012) completed a meta-analysis of over 1200 patients, which showed statistically lower adjacent level re-operation rates for artificial discs (17).

Also interesting to note, the reimbursement for surgeons performing disc arthroplasty is lower than that for fusion surgery (at least based on Medicare’s RBRVS system, which is replicated by nearly all commercial payers). In fact, several national insurers (including Aetna, Cigna, United Healthcare and Humana) cover cervical artificial discs and NC surgeons, such as myself, continue to implant them despite surgeon reimbursement rates ~30-70% less than comparative ACDF. This certainly begs the question, if artificial discs are ‘ineffective’ as described by the BCBSNC website, why are there multiple FDA approvals (eight overall, three in the last year alone), why are several other large insurers providing coverage for them and why are surgeons implanting them despite a significant pay cut to do so?

BCBSNC is certainly entitled to hold its own opinion of artificial discs, despite a preponderance of scientific evidence to the contrary, but it is simply inaccurate and misleading to represent that opinion as fact on a public website. Furthermore, while it is BCBSNC’s prerogative to deny their patients access to new technology, it is inappropriate to mask that choice by incorrectly labeling artificial discs as ineffective. We request that BCBSNC immediately delete this misleading and outright inaccurate information from your website. Since this is a patient care related issue, Wayne Goodwin, Commissioner of NC State Department of Insurance, has also been copied. We welcome any open and constructive dialogue concerning this specific topic and coverage determinations for artificial discs in general.

Please contact me if I can provide any further information or clarification.

Sincerely,

Domagoj Coric, MD
IASP Board Member
President-elect, Southern Neurosurgical Society
Chief of Neurosurgery, Carolinas Medical Center
Carolina Neurosurgery & Spine Associates
Charlotte, NC

cc: Mr. Wayne Goodwin
Commissioner
North Carolina Department of Insurance
430 N. Salisbury Street
Raleigh, North Carolina 27603-5926

References

1 Blumenthal SL, McAfee PC, Guyer RD, Hochschuler S, Geisler RD, Holt RT: A prospective, randomized, multi-center FDA IDE study of lumbar total disc replacement with the CHARITE artificial disc vs. lumbar fusion: Part 1-evaluation of clinical outcomes. Spine 30:1565-1575,2005

2 Burkus JK, Haid RW, Traynelis VC, and Mummaneni PV: Long-clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg-Spine 13:308-318, 2010

3 Chang U-K, Kim DH, Lee MC, Willenberg R, Kim S-H, Lim J: Changes in adjacent-level disc pressure and facet joint force after cervical arthroplasty compared with cervical discectomy and fusion. J Neurosurg-Spine 7:33–39, 2007

4 Coric D, Finger F, Boltes P: The Bryan Cervical Disc prospective, randomized, controlled study: Early clinical results from a single investigational site. J Neurosurg-Spine 41:31-35, 2006

5 Coric D, Cassis J, Carew J, Boltes MO. Prospective Study of Cervical Arthroplasty: 98 Patients from Three Separate IDE Studies from a Single Investigational Site with Minimum Two Year Follow-up. J Neurosurg-Spine 13:715-721, 2010

6 Coric D, Nunley P, Guyer RD, Musante D, Carmody C, Gordon C, Lauryssen C, Ohnmeiss D, Boltes MO: Prospective, Randomized, Multicenter Study of Cervical Arthroplasty: 269 Patients from the Kineflex®|C Artificial Disc IDE Study with Minimum Two Year Follow-up. J Neurosurg-Spine 15:348-358, 2011

7 Coric D, Kim PK, Clemente J, Boltes MO, Nussbaum M, James, S: Prospective, Randomized Study of Cervical Arthroplasty and ACDF with Long-Term Follow-up: 74 Patients from a Single Site with Four- to Eight-year Follow-up. J Neurosurg-Spine 18:85-95, 2011

8 Delamarter RB , Murrey D , Janssen ME, Goldstein JA, Zigler J, Tay BKB: Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS J 4: 122-128, 2010

9 Delamarter RB, Zigler J: Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion, Results of a Prospective Randomized Clinical Trial. Spine Nov 2012 (Epub ahead of print)

10 Garrido BJ, Taha TA, Sasso RC: Clinical outcomes of Bryan cervical disc arthroplasty a prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal Disord Tech 23:367-371, 2010

11 Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK. Comparison of BRYAN Cervical Disc Arthroplasty With Anterior Cervical Decompression and Fusion. Spine 34:101-107, 2008

12 Kowalczyk I, Lazaro B, Fink M, Rabin D, Duggal N: Analysis of in vivo kinematics of 3 different cervical devices: Bryan disc, Prodisc-C, and Prestige LP disc. J Neurosurg-Spine 15:630-635, 2011

13 Mummaneni P, Burkus J, Haid R, Traynelis V, Zdeblick T: Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg-Spine 6:198-200, 2007

14 Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, et al: Results of the prospective, randomized controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 9:275-286, 2009

15 Puttlitz CM, Rousseau MA, Xu Z, Hu S, Tay BK, Lotz JC: Intervertebral disc replacement maintains cervical spine kinetics. Spine 29:2809-14, 2004

16 Robertson JT, Papadopoulos SM, Traynelis VC: Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg-Spine 3:417-423, 2005

17 Upadhyaya CD, Wu JC, Trost G, Haid RW, Traynelis VC, Tay B, Coric D, Mummaneni PV: Analysis of the three US FDA-IDE Cervical Arthroplasty Trials. J Neurosurg-Spine 16:216-228, 2012

18 Zigler JE, Delamarter RB: Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine 17: 493-501, 2012

19 Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M: ProDisc-C and ACDF as Surgical Treatment for Single Level Cervical Symptomatic Degenerative Disc Disease: Five-Year Results of an FDA Study. Spine 38:203-9, 2013

20 Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO, Haider TT, Cammisa F, et al: Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 32:1155-1162,2007

21 Zigler JE, Glenn J, Delamarter RB: Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine 17:504-11, 2012