Medicare previously paid for FDA-approved TENS equipment and supplies when prescribed by a physician for chronic pain and reimbursed physicians and physical therapists for evaluating patients' suitability for the treatment.
Five pain management experts weigh in on the CMS decision.
Pamela D'Amato, MD, Pain Management Specialist, Advanced Interventional Pain Management (Clifton, N.J.): I feel that the CMS ceasing reimbursement for TENS treatment is surprising. In the climate of pain management, with the over prescription of opioid medications, it is always nice to have a non-medication and non-interventional alternative, in my arsenal of treatment options. Unfortunately, we now run the risk of the private insurance companies following the CMS's stance. It limits the concept of a multi-modal approach to patients with chronic low back pain. A TENS unit can be beneficial for a patient, they can utilize it on their own and often with little adverse side effects.
Dale Hammer, SVP Global Compliance and Government Relations, DJO Global (Vista, Calif.): We are very disappointed in the CMS decision. For over 30 years, the medical community has used TENS as a safe and effective alternative or adjunct to a pharmacological approach to pain control. It is going to be very difficult for us to tell our Medicare patients that they no longer have covered access to a technology that has helped many thousands of Medicare patients effectively and safely manage their chronic low back pain. Restricting access to this technology could necessitate greater use of potentially addictive narcotics and in some cases result in the need for surgical intervention.
An online petition collected over 10,000 patient and provider signatures asking CMS not to eliminate coverage. Nevertheless, CMS stated in their Decision Memo that "evidence from formal clinical studies is more persuasive [than patient experience] to draw confident conclusions about the impact of medical technologies." Their approach essentially discounts many years of clinician professional judgment and patient experience. Unfortunately, we do not believe that CMS has taken into consideration the impact that this decision will have on the segment of the Medicare population with chronic low back pain.
CMS has stated that they may reconsider their decision based on favorable results from randomized clinical trials, however, aside from the fact that such studies cost millions of dollars and take years to complete, we do not believe such studies are necessary or appropriate for TENS technology. While additional evidence can help refine treatment practices for virtually any medical technology, there are very few circumstances that justify essentially revoking patient access to a technology that has been long accepted in the medical community and has no safety concerns. Given this is the approach the CMS has decided to take, however, we feel that CMS should delay any coverage restrictions for at least two years so that the Medicare population is not denied longstanding Medicare coverage during this evidence-gathering process.
Moshe Lewis MD, Chief of Department of Physical Medicine and Rehabilitation, California Pacific Medical Center (San Francisco): In a time where CMS is looking critically at treatments that can be cut due to limited benefit, TENS units will have to be covered by patients. The literature shows that while they are of benefit in a small number of patients, the majority of patients do not benefit from this intervention. Now, given modern technology TENS unit costs have decreased to the point that most people can afford to buy these independently.
Charles Chabal, MD, President of the Washington Academy of Pain Management, Pain Management Specialist, Evergreen Pain Management (Kirkland, WA): As a board certified pain management specialist who offers both interventional and pain management treatment, I believe the CMS decision to revoke coverage for TENS goes against a long history of many pain physicians' clinical experience.
I believe there are many problems with the Cochrane review studies that influenced CMS' decision unfortunate — and I believe misguided — decision about TENS treatments. For example, I and many of my peers and colleagues believe that the global outcomes measures used in those studies may not have targeted the appropriate intervention. In addition, I don't believe the Cochran review studies controlled for comorbid psychosocial factor such as undiagnosed depression, poorly treated depression, sleep disorders, quality of life or anxiety. Also, as we've seen in my home state of Washington, the sponsoring agency of a study often picks statistical consultants who clearly have a bias towards these review methodologies. There is a growing body of literature to support the bias and limitations of these review analyses.
I would also add that many pain specialists use TENS to treat exacerbations of low back pain. The mainstay long-term treatment of LBP often includes physical exercise and medication management. However, in the real world, most patients will suffer from acute flare-ups and exacerbations within the context of their chronic condition. For these flare-ups, TENS is very useful non-drug option. Unfortunately, most Cochrane review articles make little or no mention of this common and effective use. As professional societies and government health organizations highlight the limitations and complications of pain medications such as opioids (overdose, death, falls and fractures, constipation, etc.), NSAIDS (bleeding and kidney failure) and acetaminophen (hepatic toxicity), I find it ironic that our ability to offer an effective non-drug intervention will be limited. This has the effect of limiting very safe options for both the treating physician and patient and forcing treatments that clearly have potential serious side effects and complications.
Scott Gottlieb, MD, Director of Pain Management, New York Eye and Ear Infirmary (New York City): If TENS units are not covered, it would be a huge setback for pain patients because there is not a sufficient amount of safe, effective, non-invasive treatments for pain. There is a lot of risk when prescribing pain medications (narcotics) and a TENS unit has none of the issues that narcotics are associated with. If a TENS unit has provided relief to millions of low back pain sufferers, why eliminate it?
Jeremy Scarlett, MD, Pain Management Specialist, Advanced Pain Management (Milwaukee, Wisc.): I see the recent CMS decision to halt reimbursement for TENS treatment for chronic back pain as yet another setback in the field of pain management. Any depletion in the treatment arsenal is a setback for a difficult to treat condition. Opioids, antidepressants and muscle relaxants provide some nonnarcotic benefit, but they often have side effects. Many of my patients, particularly the elderly, want a fast-acting solution for their pain that provides minimal sedation and does not affect their mental clarity or bowel function. The TENS unit is an excellent option for these patients and others who will suffer if TENS treatments are no longer covered by CMS.
In the face of the national crisis of opioid dependence, addiction and abuse, CMS is making a decision that takes away a viable alternative to the prescription of narcotics. Patients who receive TENS treatments do not run the risk of addiction or face dangerous interactions from mixing alcohol or benzodiazepines with treatments. I wish CMS would consider the direct and indirect costs both to the patient and to society of the alternatives to the therapies they no longer cover.
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