View Original Article
Written by Taryn Tawoda | June 13, 2012
The Centers for Medicare and Medicaid Services last week announced that most uses of transcutaneous electrical nerve stimulation will no longer be reimbursed as treatment for chronic low back pain. In a memo released Friday, CMS officials wrote that reimbursement for TENS will be available only when patients are participating in a randomized, controlled trial to gauge the clinical effectiveness of the treatment.
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, MA, PT, MHSA, 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.
New Jersey residents who register this week to qualify for medical marijuana will be able to visit a Rockland doctor to get a prescription.
The state’s registry opens Thursday for people who meet stringent requirements to qualify for medical marijuana. A total of 150 physicians licensed in New Jersey have met the state’s qualifications to dispense the drug, according to a spokeswoman.
Dr. Scott Gottlieb, an anesthesiologist and pain management physician with an office practice in Montebello, is among them.
View Original Article
Although the term “epidural” is commonly associated with an injection given to women during labor, an ESI (epidural steroid injection) can be used as a relief for many different circumstances of pain in both men and women. An epidural injection is a procedure that is typically used to help alleviate neck and back pain (in addition to arm and leg pain) caused by inflamed nerves.
How it works:
An epidural steroid injection essentially involves bathing an inflamed nerve root in order to decrease the irritation of the nerve root that is causing pain. Despite the simplicity of this common practice, there are many myths and concerns associated with the beneficial procedure.
During the steroid injection, a needle (the size of a thick strand of hair) and syringe are used to enter the epidural space and deposit small amounts of long-lasting steroids around the inflamed spinal nerve. The simple method is performed through fluoroscopic guidance; the viewing instrument is used to visualize the local anatomy during the injection. Afterward, the needle is placed into the epidural space, targeting the inflamed area with a maximal amount of steroids, thereby minimizing exposure of the rest of the body to the steroids.
What to expect:
Although many myths have projected the idea that ESIs are an instant cure for pain, the injections are not an overnight fix to the enduring discomfort of a patient. The epidural, however, generally helps the patient resume his or her normal activities by alleviating the pain so that the patient can proceed to seek physical therapy to slowly strengthen and heal the area that has caused them discomfort.
The effects of ESIs are different with every patient as some injections provide long-term relief of up to a year and others experience short-term relief consisting of a few weeks to a small number of months. It is usually suggested that no more than three ESIs are administered within a 6 month time frame.
Those receiving an ESI for back and nerve pain will have their vital signs examined and pain relief will be assessed frequently throughout the procedure. If there are any possible side effects from the medicine, the anesthesiologist on duty will be involved. Similarly to the symptoms experienced by women during an epidural for labor pain, some possible side effects include drops in blood pressure, itching, and nausea/vomiting depending on the amount of dosage received by the patient.
Keep in mind:
While ESIs are a useful non-surgical treatment for many patients, they are not right for everyone. Those suffering from infection, bleeding problems, or spinal tumors are not recommended candidates. It’s important to note that as with any type of injection, there are some risks associated with ESIs. Some major risks include bowel and bladder incontinence, infections, headaches caused by epidural punctures, nerve damage, and bleeding.
An anesthesiologist will be involved in the management of this procedure to ensure the best possible outcome in providing pain relief, minimizing side effects, and ensuring your overall safety. However, it is important to assess the risks and benefits of an epidural steroid injection with your doctor to help determine if this treatment plan will be right for you. This form of pain management may also not work for everyone. If the injection does not provide relief, a new treatment may be better suited for you.
About Dr. Scott Gottlieb:
Dr. Scott Gottlieb is a pain management expert and the founder of Gramercy Pain Management. He is the director of Pain Management at New York Eye and Ear Infirmary (NYEE) and has treated over 3,000 patients. Dr. Gottlieb is board certified in both pain management and anesthesiology. He has offices in both Manhattan and Montebello, N.Y. in Rockland County.
Because multiple sclerosis is a progressive disease, your pain management plan might need repeated tweaking. Options, include physical therapy and targeted exercises, pharmaceuticals, and surgical procedures. The challenge is finding the right combination of treatment strategies that works for your particular symptoms at a given point in time.
What works well for one person may not work well enough for another, and medication that used to bring symptom relief for problems, such as spastic paralysis and muscle spasms, may suddenly stop being effective. Now, in 17 states and the District of Columbia, there’s a newer option — cannabis sativa, otherwise known as medical marijuana to treat MS symptoms.
“Pain associated with multiple sclerosis can often be very difficult to treat,” says Scott Gottlieb, MD, a pain management specialist at Manhattan’s New York Eye and Ear Infirmary. Licensed to prescribe medical marijuana at his private practice in New Jersey, Dr. Gottlieb says it can be helpful in treating the pain of MS symptoms and can do so without the typical side effects associated with high-dose opioids, a common prescription drug used for managing pain associated with multiple sclerosis. Gottlieb points out that although opioids such as morphine, oxycodone, and methadone are effective pain drugs, many people develop a tolerance to them and require higher doses as time goes on. “As far as I am aware, this is not the case with marijuana,” Gottlieb adds.
California resident Y.W. White agrees. “A few puffs, and I feel relief for the day,” she says, describing the calming effect it has during bouts of spasticity and muscle spasms. “I take pharmaceuticals, too, but they don’t work as well as pot.”
Marijuana Side Effects
“As helpful as marijuana can be, it is not without its own side effects,” cautions Gottlieb. Problems may include:
• Impaired mental functioning
• Decreased inhibitions
• Dry mouth
• Memory problems
• Blurred vision
• Increased anxiety or paranoia
• Respiratory problems
• Dizziness and loss of balance
• Sexual problems
You might encounter some, all, or none of these side effects. When they occur, they’re usually short-lived and go away within 24 hours, Gottlieb says. White’s experiences follow that timetable. She says she’s had temporary memory loss from time to time, but it’s never been long-lasting. She also experienced anxiety from marijuana at one point. That’s when she learned from her doctor that she needed to use the right type of marijuana because different types have different side effects. White was using cannabis indica at the time, and her internist recommended she switch to cannabis sativa. Since she switched, she says, anxiety hasn’t been an issue. And, regardless of the side effects she’s experienced, White says she believes the benefits of cannabis sativa outweigh the risks.
Why Isn’t Marijuana Easier to Get?
White thinks she’s been lucky. “My doctors have been behind me and understand that it is a medicine and is helpful,” she says of her access to cannabis sativa. Two of her main concerns are cost and quality control. She wishes more people understood the benefits of the medication as well as the benefits of having reputable dispensaries so that people who need it can get good quality at a reasonable price.
Outside of being an illegal substance in most states, medical marijuana is not widely available because verifiable data proving its effectiveness has been limited. “There are numerous anecdotal reports of improvements in some of these symptoms with the use of cannabis, yet well-controlled study results demonstrating benefits are scarce,” explains Paul B. Langevin, MD, of the department of anesthesiology and critical care at Hahnemann University Hospital in Philadelphia.
However, researchers have seen the potential and are looking for ways to use derivatives of cannabis as ingredients in pharmaceuticals. Dr. Langevin points to an MS study in the European Journal of Neurology, in which 272 out of 572 participants had at least a 20 percent reduction in spasticity from nabiximols (Sativex), a cannabis derivative. And a British clinical trial called Cannabinoid Use in Progressive Inflammatory Brain Disease (CUPID) found that THC, the main active component of cannabis, taken orally may provide some benefit for people at the lower end of the MS disability scale.
Researchers who’ve seen results from medications derived from extracts of cannabis sativa hope that they’ll be approved for distribution in the United States. This would allow people with MS to decide for themselves if they’re beneficial.