Centres of excellence for neuromodulation: A critical proposal

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While recognising that excellence derives from experience, Robert M Levy suggests that the neuromodulation community can better protect the field’s “desire to ensure excellence for patients and healthcare economies”. Here, he makes a case for establishing centres of excellence for neuromodulation therapies. Although acknowledging the benefits that this will bring, for both patients and healthcare providers, Levy writes, “I expect that not everyone will support this proposal due to self-interest or economic concerns”.

Robert Levy
Robert Levy

As a field, neuromodulation has struggled with methods to increase the efficacy of our procedures, decrease the associated risks, and improve patient outcomes. By achieving the latter, we further legitimise our field, improve patient satisfaction and demonstrate the cost-effectiveness that is necessary to drive reimbursement, in turn improving patient access to neuromodulation procedures. One important way to improve results in our specialty is to ensure that neuromodulation practitioners have, indeed, practiced. And practiced quite a lot.

In his book, Outliers, Malcolm Gladwell points to the correlation between the level of practice and excellence. “The idea that excellence at performing a complex task requires a critical minimum level of practice surfaces again and again in studies of expertise. In fact, researchers have settled on what they believe is the magic number for true expertise: 10,000 hours.”1 While Gladwell discusses excellence in sports, music and computer science, this correlation appears to hold for virtually any discipline. He quotes Daniel Levitin, a neuroscientist whose research focuses on the development of excellence: “The emerging pictures from such studies is that 10,000 hours of practice is required to achieve the level of mastery associated with being a world-class expert—in anything.”2 Gladwell goes on to state that “practice is not the thing you do once you are good. It is the thing you do that makes you good”. He suggests that it takes about 10 years to develop such excellence.

Though the actual amount of practice required may be debated, the recognition that excellence derives, at least in part, from experience, cannot. Unfortunately, there appears to be a conflict between the way in which neuromodulation is practiced and our desire to ensure excellence for our patients and our healthcare economies. That is to say that less than 20% of spinal cord stimulator (SCS) implanters, for example, perform 80% of these procedures, leaving 80% of implanters to do no more than 20% of SCS implants. The vast majority of implanters perform less than 12 such procedures a year; possibly too few to ensure quality, much less excellence.3

Centres of excellence in neuromodulation

In the field of neuromodulation, the correlation between high practice volumes and high quality outcomes has not yet been definitively established, even though it has for other procedural fields, including vascular surgery, cardiothoracic surgery, cancer surgery and bariatric surgery.4-18 Yet, it is unlikely that neuromodulation is unique. There are approximately 4,000 implanters of SCS devices in the USA; it is almost a certainty that the outcomes of implanters performing 100 or more procedures per year would be better than those performing 10 or fewer procedures per year. However, 80% of implanters perform one procedure per month or less. In light of these statistics, it is not surprising that the adverse event rates in neuromodulation—although improving in recent years—continue to occur at too high a rate compared to other similar surgical procedures.19

A not dissimilar situation exists for deep brain stimulation (DBS) procedures. Approximately 500 surgeons perform 13,000 DBS procedures each year. Only 11% of surgeons perform 50% of these cases (averaging about 120 cases per year), with the remaining majority performing on the average of 15 cases per year.

There is now developing data that suggests that the correlation between surgeon volume and outcomes applies to the field of neuromodulation as well. Sharan and co-workers recently examined adverse events and patient response rate as a function of surgeon experience as part of a 52-week prospective, randomised, controlled multicentre study of peripheral nerve stimulation (PNS).20 Surgeon experience with PNS played a major role in reducing all device-and procedure-related adverse events, including biological, stimulation-, and hardware-related adverse events (p<0.005). Frequently observed device-related adverse events, such as lead migration, infection, pain at the internal pulse generator pocket and/ or the lead implant site, decreased as a function of the experience (p<0.005) by approximately 80%, 60%, and 50%, respectively, when surgeons had performed greater than 10 prior procedures. Treatment response rate improved significantly as a function of experience (p=0.001), with the response rate increased by approximately 20%, 10%, and 13% at the 4-, 12- and 52-week follow-up visits, respectively.

Benefits of neuromodulation centres of excellence

By establishing centres of excellence (COE) for neuromodulation therapies, we can provide significant benefits to our patients and healthcare providers as well. First, the COE would house groups of busy, highly-skilled implanters whose outcomes are likely to be better than local providers performing these procedures only rarely.

Next, the improved quality of the neuromodulation training environment promises to be a second important benefit of the COE concept. In a recent fellowship training programme, I was surprised to find that at least half of the pain fellows had not participated in a single neuromodulation surgery and had seen less than a handful performed by their faculty. Undertaking a neuromodulation fellowship in a practice that perform hundreds of these procedures each year would provide a significantly enriched environment for hands on education and training.

A COE model, where hundreds of similar procedures are performed each year would further provide an economy of scale. Many of the costs of a neuromodulation practice are fixed costs that are largely unrelated to volume. These practices require nurses and other mid-level providers, such as medical and surgical assistants, to refill and reprogramme intrathecal drug administration systems or to oversee device trials; perform programming of DBS, SCS and PNS neurostimulation systems; assist with the care of the patient’s non-surgical needs, or with record keeping, data input and outcomes data development as well as many others.

A high volume neuromodulation practice can spread the cost of these critical personnel across a large number of patients and procedures to make them cost effective. One particularly important need for a high quality neuromodulation practice is access to a psychologist for pre-surgical assessment, patient education and ongoing therapy. The cost of these services is frequently minimally or not reimbursed; a high volume COE model can incorporate the cost of psychological support as part of the cost of doing business without putting the practice at risk. In short, the neuromodulation multidisciplinary team model can be much more easily accomplished within a high volume COE.

There are operational issues that are more easily addressed in such high volume practices as well. It is frequently the case that in smaller neuromodulation practices, there are long delays between patient medical evaluation, psychological evaluation, the therapeutic trial and the permanent implant. As a result, only 21% of patients evaluated by neuromodulation physicians as being good candidates for these procedures ultimately undergo the procedure.3 Practices often lose track of patients as they navigate these systems; they are lost to follow-up or they may lose their vigour to pursue therapy and simply suffer in silence.21

In a high volume COE model, case managers who can shepherd patients through the process become potentially cost-effective, and help to ensure that patients reach their goal of receiving potentially effective therapy. Those office personnel involved with obtaining insurance approval, appropriate reimbursement, hospital scheduling, and outcomes data collection can only become more proficient and efficient as a result of a higher volume, ongoing experience. This not only improves patient throughput and office efficiency but also avoids uncomfortable delays, which can result in patient dropout or poor patient satisfaction.

A most important collateral benefit of a high volume COE model is the improved ability to collect and process outcomes data. As health care systems evolve around the world, the ability to provide meaningful outcomes data is becoming the key to obtaining and maintaining appropriate reimbursement, as well as increasing understanding of our therapies and their outcomes. The adoption of and rigorous adherence to a common outcomes database across neuromodulation COEs would allow for pooling of data and large scale validated research programmes.

Of equal importance, I would hope that the resulting reliable outcomes data should demonstrate greatly improved and cost effective outcomes when compared to the large number of small, less experienced and lower volume practices.

The high volume COE model would make it easier for industry to identify important sites for educational and research support. Both industry and consumers would benefit; the industry can well expect more “bang for the buck” from their support due to the large volume and great influence of these centres, while patient and health care provider consumers can expect higher quality educational programmes and more expert implanters and teachers. Further, by consolidating volume into fewer sites, COEs could decrease the service burden of the vendors that supply neuromodulation devices.

I would propose a national health system of neuromodulation CEOs. About 60,000 permanent SCS procedures are performed each year in the USA alone. With an overall estimated trial to permanent implant ratio of 65%, this adds 92,000 spinal cord stimulation trial procedures per year.3

Finally, there are approximately 13,000 permanent deep brain stimulator implants in the USA each year. Without including peripheral nerve stimulation or peripheral nerve field stimulation procedures, this accounts for at least 165,000 neurostimulation procedures in the USA annually. With 200 centres of excellence throughout the country, each centre would perform over 800 procedures per year not including peripheral nerve or nerve field stimulation procedures. It is hard to imagine that the quality of patient outcomes would not be better than they are now, where the overwhelming majority of implanters perform less than 10 procedures per year.

Defining neuromodulation centres of excellence

We are left with the challenges of defining what makes a neuromodulation COE and who should be responsible for defining and monitoring such centres of excellence. While industry is often called on to make these determinations, I believe that this is improper.

First, industry cannot refuse to sell product to a licensed physician. Second, the requirement to satisfy the needs of industry stakeholders creates a potential conflict between the objectivity needed for establishing and monitoring centres of excellence and the need to maximise profits. Third, the medical device industry is not in the business of providing healthcare; doctors can best dictate the requirements for optimal medical care programmes.

Unfortunately, the medical profession in general, and the field of neuromodulation in particular, has been remarkably slow to own up to their responsibilities. Already, governmental agencies or their agents have stepped forward to begin to regulate the practice of neuromodulation.22 I believe that professional regulation by knowledgeable medical societies is preferable than that by governmental agents.

So again, what are the components of a neuromodulation centre of excellence? I would propose that they include, but are not limited to:

  1. Physicians performing more than some critical number of neurostimulation procedures per year.
  2. Institutions that provide comprehensive access to US FDA approved neurostimulation procedures (DBS, SCS, PNS, IT DAS).
  3. Institutions whose complication rates fall below a critical level.
  4. Institutions whose outcomes and patient satisfaction rates are above a critical level.
  5. Institutions that collect data using appropriate instruments so that they can produce reliable outcomes and complication data.
  6. Institutions that have available all necessary ancillary services (i.e., psychology, physical therapy, etc.).
  7. Institutions that demonstrate certain levels of efficiency and proficiency in patient evaluation, screening, trialling and performing surgery.
  8. Institutions that provide acceptable long term therapy maintenance.
  9. Institutions that consent to regular monitoring of these variables.

As is often the case, however, the devil is in the details. How we define and quantitate each of these variables, and how we choose to measure and monitor them, is the difference between success and failure for a COE programme.

I charge our professional neuromodulation societies to act quickly and decisively to enact these programmes for the sake of our field and our patients.

Conclusion

I expect that not everyone will support this proposal due to self-interest or economic concerns. I expect that most objections will come from medical societies and practitioners bent upon maintaining the status quo and focused on the desires of individual practitioners. Unfortunately, the time for this type of protectionism has long passed.

In fact, insurance companies are already leading the way in this regard; they have already initiated programmes to increase scrutiny and limit or withdraw reimbursement to practitioners with poor outcomes.22 In this day and age, we must first consider the wellbeing of our patients, second the cost effectiveness of our therapies and finally, the survival of our field.

On the other hand, especially during the current evolution of the healthcare system in the USA and the economic challenges to healthcare around the world, it seems that the field of neuromodulation has something significant to offer both our patients and healthcare payers. By improving outcomes through better patient selection, a higher level of surgical skills and improved post-procedural care and therapy maintenance, we can offer a better level of care to our patients at a significantly lower cost. In the equations used by healthcare systems to determine willingness to pay for a given therapy, we can help by both increasing patient outcomes while also decreasing costs. The resulting drop in cost per quality-adjusted life year may ensure continued acceptance of neuromodulation therapies and access for our patients.

Robert M Levy currently serves as president of the International Neuro­modulation Society and Editor-in-Chief of Neuromodulation: Technology at the Neural Interface.

References

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  2. Levitin, DJ. This is Your brain on Music: The Science of a Human Obsession (New York: Dutton) 2006. P. 197
  3. St. Jude Medical, 2013, personal communication.
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  14. Cowan, JA JR, Dimick, JB, Henke, PK, Huber, TS, Stanley, JC, Upchurch, GR Jr. Surgical treatment of intact thoracoabdominal aortic aneurysms in the United States: Hospital and surgeon volume-related outcomes. Presented at the Twenty-ninth Annual Meeting of the New England Society for Vascular Surgery, Rockport, Me, Oct 4-6, 2002.
  15. Justin B Dimick, John A Cowan Jr, James C Stanley,Peter K Henke, MD, Peter J Pronovost, Gilbert R Upchurch Jr Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the united states. Presented at the Thirty-sixth Annual Meeting of the Association for Academic Surgery, Boston, Mass, Nov 7-9, 2002
  16. Harmon JW, Tang TG, Gordon TA, Bowman HM, Choti MA, Kaufman HS, Bender JS, Duncan MD, Magnuson TH, Lillemoe KD, Cameron JL. Hospital Volume Can Serve as a Surrogate for Surgeon Volume for Achieving Excellent Outcomes in Colorectal Resection. Annals of Surgery. 1999 Sept;230(3):404-11; discussion 411-3
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  18. Dimick, JB, Osborne, NH, Nicholas, L, Birkmeyer, JD. Identifying High-Quality Bariatric Surgery Centers: Hospital Volume or Risk-Adjusted Outcomes. J Am Coll Surg. 2009 Dec;209(6):702-6. doi: 10.1016/j. jamcollsurg.2009.09.009.
  19. DeBakey, M. Medical Centers of Excellence and Health Reform. Science. 1993 Oct 22;262(5133):523-5.
  20. Sharan, A, Huh, B, Narouze, S, et al. Impact of surgeon experience performing peripheral nerve stimulation surgeries on treatment efficacy and safety. North American Neuromodulation Society Annual Meeting, December, 2013, Las Vegas, NV
  21. Levy, RM. Patient Targeted Therapy. Presented at the North American Neuromodulation Society Meeting, Las Vegas, NV, December, 2012.
  22. Local Coverage Determination (LCD): Spinal Cord Stimulators for Chronic Pain (L32549).(2013)

 


1 COMMENT

  1. COE’s will need to include safety net hospitals and each ACO hospital group to assure patient access to care. There already exists limits to patient access based on Medicaid coverage and providers who do not accept and ACO rules. It is also interesting that you do not mention targeted drug delivery as a therapy that warrants COE. Pediatric centers have developed programs that have some of the best practices and have valuable information to share.

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