Shorin Nemeth, DO FACOI, Medical Director Comprehensive Pain Service, Providence Health and Services
The field of Pain Management has always suffered from an identity crisis. Toward the latter end of the last century, multidisciplinary pain centers seemed to be the standard of care. For clarification, a multidisciplinary center is a practice that involves specialists from different fields. For instance, there may be a pain physician, pain psychologist or social worker, pain physical therapist or occupational therapist, and Complementary and Alternative practitioner all working together. Then, with a push toward pharmaceuticals, particularly opioids, the reimbursement for multidisciplinary centers dwindled and the focus shifted to the interventional pain provider who treated pain with medications and interventions (epidural injections and similar).
When the opioid crisis struck, pain providers found opioid prescribing challenging due to the numerous regulatory burdens imposed after the widespread overprescribing of opioids and resulting morbidity and mortality. Even before this, some pain centers had transitioned over to purely interventionally focused, only offering recommendations for prescribing, but not actually prescribing any medications. The development and refinement of intrathecal pumps, spinal cord stimulators, and radiofrequency ablation furthered the interventional model. This provided a large gap in care whereby a patient could receive interventional treatment or try and find a prescriber who would treat their pain pharmacologically. This binary model of either injections or medications left many patients without the relief for which they hoped. Physical therapists such as Professor Lorimer Mosely and others from the behavioral health realm seemed to show promise with their treatment models, seeming to bring the practice full circle back to a multidisciplinary practice, at least in theory.
"As technology evolved, pain providers were able to take advantage of a wider variety of tools"
As the technology evolved, pain providers were able to take advantage of a wider variety of tools. For instance, with refinement in ultrasound technology, the prices of ultrasound machines came to a point where many office-based practices could not only afford them but rather considered them the standard of care for various procedures. With the increased use of ultrasound came improvements in imaging resolution, refinement in needle technology, and computer algorithms to allow better visualization of the needle tip, etc. Similarly, for radiofrequency, spinal cord stimulators, and other technologies, the advancement of the technology made the tools safer, arguably more effective, less cumbersome, less costly, and easier for the physician provider to use.
From the perspective of non-interventional tools addressing the behavioral aspect of pain, pain education, and treatment of traumatic life events, advances continue to be made in the realm of computer-based education, but the technology has not yet reached the point where it can be implemented into practice without significant hurdles. The one exception to this may be the increase in virtual/telehealth usage which has allowed group education and behavior change-focused groups to come together virtually, arguably decreasing barriers to attendance.
The single biggest problem remains getting reimbursed for appropriate care for patients suffering from pain. I think the reason for this is a simple fact that the patient population is not homogenous. Some patients have uncomplicated pain from a pinched nerve in their low back who will respond very well to physical therapy and an epidural injection. In these patients, the pain is still predominantly maintained by peripheral nerves. However, others may present with similar symptoms, but, upon closer examination, also have depression, anxiety, sleeplessness, a history of horrible childhood trauma, food, and housing instability, and other challenges. In these patients, the pain is not going to respond to treatments targeting the peripheral nervous system because their pain is at the level of the central nervous system.
Reimbursement models do not take this into account. For instance, the latter patient described above is placed in the same category as the former “simple” patient when one reviews the outcome data on epidural injections and other interventions. Because it is well known that an injection will not help with pain from the central nervous system, some of the data would appear to imply that injections are not helpful as a whole. As a result, some insurers have concluded that injections are not helpful for anyone in pain and have stopped paying for them largely because the studies evaluating their efficacy do not consider the psychological and psychosocial variety within the pain population. Instead, they largely focus on anatomical variations. Conversely, some providers have taken advantage of the fact that higher reimbursement is realized by focusing predominantly on patients who can receive injections. I do not pretend that this relationship is novel to Pain Management, but rather is the tug of war that plagues all of medicine.
Perhaps a more tangible challenge would be the training of pain specialists. Many of the fellowships for pain specialists tend to focus on the safe administration of injections and only provide minimal teaching about the treatment of more complex, what we call centralized pain. The multidisciplinary model is mentioned, but little training is given in how to work in a carefully integrated team. Mitigating this challenge would simply require the majority of pain providers, professional pain societies, and pain training programs to restructure the entirety of post-medical school training and develop an entirely new way of training any who treat pain. Another swing and a miss, I’m afraid.
At the end of the day, medicine is still a business. If a physician or other medical provider is not adequately reimbursed for the work they are doing, they will stop doing that work simply because they cannot keep their doors open solely with good intentions—regardless of efficacy. So, I would say if we know that multidisciplinary pain treatment is the most effective way to approach the problem, providing adequate reimbursement for that solution would help. Since the change curve in medicine tends to be about 15-20 years in length, that solution will hopefully come at some point before I stop practicing medicine, but I won’t hold my breath. Thus, effectively mitigating this challenge means looking for solutions to help the medical community become more effective or have a broader reach. An example might be leveraging the virtual learning environments to help patients learn about pain or help patients get better at exercise. If we could have a patient work with a computer instead of one on one with a medical professional, we have become more effective and allowed that medical professional to dedicate their time to those outside the bell curve of the target audience for these interventions. The parting caveat to this is that this technology cannot increase the cost of doing business.
The chronic pain market is huge, impacting an estimated 20 percent of the US population. Because of this, there are many devices and emerging technologies trying to enter this space. If a business wants to be effective in this space, there are a few basic tenants.
First, decide how you want to be compensated for your technology. The options would be reimbursement directly from insurance companies, direct-to-patient pricing, or a hybrid model. If an insurance company is involved, one will need numerous clinical studies to back up the efficacy of the product. Then, since there are regional variations in insurance coverage, one will need to know the insurers needed to target each region in order to gain reimbursement. There are plenty of great products with reasonable to high efficacy which is not utilized due to lack of insurance coverage. This is fine as long as one realizes your market share may be limited only to the small percentage of patients experiencing chronic pain who can pay out of pocket. So, the compensation model and price point, as in any business venture, may limit growth potential. The upside of insurance reimbursement is a broader market for your product. The downsides are the numerous regulatory hurdles, clinical studies needed, and reimbursed pricing may not net a large revenue stream.
Secondly, ensure your product does not negatively influence the workflow of the targeted area.
Whether targeting a hospital environment or an ambulatory setting, medicine has evolved to be as efficient as possible given the ridiculous documentation are regulatory constraints. Thus, any product that introduces more work or an additional layer of complexity will not be adapted. A product should improve outcomes, improve efficiency, and decrease the workload of the medical community. As an example, if an app has great content but someone from the medical community needs to spend 20 minutes educating the patient on how to use the content or the app itself, complexity has been introduced and the efficiency of the office or hospital has been decreased. This product will not be adopted. If one is targeting a certain setting, make sure that the existing work-flows are well understood.
Thirdly, ensure your product has the appropriate clearances. The medical space is filled with regulations. If the product will be used exclusively or largely for medical purposes, an FDA clearance may be required. If this is the case, ensure you have projected the cost and timeline for this process in the proforma. Clearance also applies to data handling. Make sure your company fully understands the security measures and federal privacy laws to which one must adhere to protect any data collected. If your device has Wi-Fi capability, what means of encryption are employed? Although this is a smaller paragraph, a novel could likely be written about the complexities of this subject.
Lastly, provide accessible product support. As mentioned above, no medical setting has the capacity to absorb additional burdens. If a product stops functioning and needs troubleshooting, ensure that the end-user has easy access to support. This may seem intuitive, but products will fail because nobody in the medical community has the time nor expertise to troubleshoot technology.
Concerning the development of new technological solutions, I would offer the following. The most important premise is, and this may seem basic, but, know what specific problem in the Pain Management space your technology is designed to address. The corollary to that is to make sure that the perceived specific problem is actually a problem that needs a solution.
The problem with technology today is that, as alluded to above, it evolves at a pace that far exceeds the change curve of medicine. Because of this, I have seen many companies start with a technological solution and then try and convince the Pain Management field that their solution is necessary. Please don’t do that. We don’t need sales and marketing. We need help caring for patients. Start with the patient experience, insurance companies, or the medical practitioners and understand where workflows are impeded or the delivery of care is challenged. Medical care is full of inefficiencies that would welcome technological solutions. The last thing we need is someone who doesn’t understand our processes trying to create a solution for some new piece of technology they designed that costs too much money, doesn’t improve our efficiency, and doesn’t solve any problem known to us.
I could easily write a whole article on the opportunities for improvement and the myriad of inefficiencies in our medical system but will spare the reader that narrative today.
Any one of us can fall ill. I had the good fortune of meeting a gentleman who was a software developer (if you are reading this please forgive my ignorance of your exact technological background) who had the misfortune of being diagnosed with lung cancer. He has published an article about his journey through the cancer experience that provided myself, someone with many years of treating cancer-related symptoms, an eye-opening perspective. As he was going through the treatments, he realized that the patient experience for someone living with cancer was an overwhelming and painful burden. Through interactions with other patients, he learned that his experience was very common but just dismissed it as a part of the cancer experience that must just be endured. When he was on the other side of his treatments, he set his sights on using his software development talents to improve the quality of life for those going through cancer treatments. This is an example of a very real problem in medicine starting the process for the development of a technological solution. Let the dog wag the tail, not the tail of the dog. The key points are that he started with a problem and that problem was confirmed to be prevalent enough in the medical community to warrant the development of a solution.
A second premise is that the medical industry is not the cash cow many think it is. Very few to no hospitals nor medical providers are making huge or even modest margins on anything they do. Working for a large healthcare organization, I am often approached by vendors who feel if they can just get their foot in the door with me, they will be able to distribute their product throughout the entirety of our operations. It doesn’t work that way because, well, math. Reimbursement for anything is negotiated with insurance companies or fixed by Medicare or Medicaid. If we cannot get reimbursed for something, chances are we cannot afford to integrate it into our practice.
For instance, virtual reality has been around and available in the medical community for over 20 years. However, despite evidence suggesting its usefulness in many aspects of pain management, the cost of the hardware and lack of reimbursement by insurers has prohibited its adaptation. Aside from philanthropy, medical practices have had no means by which they are able to access this technology. This is on the precipice of changing with a recent FDA Breakthrough Device Designation thanks to the herculean efforts, vision, and tenacity of an innovative company out of Van Nuys, CA, but, recall that over 20 years have gone by in order to find this technology a suitable home in the medical industry. FDA designation along with clinical studies will help get this company a seat at the table with the insurance companies who may decide to reimburse for this tool, which would then allow more widespread adaptation. It is at this point the technology becomes clinically meaningful to someone such as myself.