Thoughts on CMS canceling reimbursement for TENS treatment

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Written by Taryn Tawoda | June 13, 2012

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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.

Radiofrequency Ablation: Say Goodbye to Chronic Pain

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Chronic pain is not an easy issue to live with. With today’s advanced technology, Radiofrequency Ablation (RFA) has made it possible to eliminate this debilitating ailment.

RFA is a procedure used to reduce pain by utilizing electrical currents produced by radio waves that heat up a small area of nerve tissue and decrease pain signals from the pungent area.

More than 70 percent of patients treated with RFA experience relief. The alleviation can last six to 12 months, sometimes even years.

People who are treated using RFA are often long-time chronic low-back and neck pain sufferers due to the deterioration of joints from arthritis.

During the RFA procedure, an IV is placed into a sufferer’s arm vein along with anesthesia, to ease discomfort. The person will be awake while the doctor inserts a small needle into the chronic area. The doctor then uses an X-ray machine to guide the needle in to the specific region.

A microelectrode (a small electrode with a tip that can be inserted into the wall of a single cell) is then inserted through the needle to begin the stimulation process. A small radiofrequency current is then sent through the electrode into the nearby tissue, heating it.

The side effects of RFA may include:

  • Leg numbness: This may occur because of the anesthesia given during the procedure and should only last a few hours.
  • Mild back discomfort: Patient can develop this when the anesthesia wears off and usually lasts two or three days. Applying ice to the area the day of the procedure and moist heat the day after can help decrease the ache.
  • Discomfort: This can include swelling and bruising at the site of treatment

This procedure has been proven to be a safe and successful way to treat some forms of pain. RFA is not recommended for people who have active infections or the ability to form blood clots.

 

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.

Small Gestures: Simple techniques to manage tension and minor pains on the road

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By Phyllis Hanlon

Some days you feel as if you are stuck in a pressure cooker. Traffic, deadlines, issues at home that you can’t deal with because you’re on the road. It happens to everyone at some point.

So how do you ease the stress and bring on the calm?

A simple technique known as mudras might help. An ancient practice dating back to ninth century India, mudras integrates hand movements with self-awareness and conscious breathing to reframe thinking, according to Emily Fuller Williams, LMT and author of Mudras: Ancient Gestures to Ease Modern Stress.

To release anxiety, Williams recommends the “calmness” mudra. It can be done in your truck, as long as you aren’t moving. Sit straight and bend the elbows so the forearms are upright, hands at ear level. Rotate the hands back and forth at the wrist (like screwing in a light bulb), keeping your fingers extended. While performing this gesture for three minutes is ideal, some people notice a difference in mood within seconds, she says.

When both hands need to be on the steering wheel, mudras can be challenging to perform. But Williams notes that pulling gently on one earlobe can lower stress levels while driving. “When there are too many ideas in your head, this helps to drain some of them out,” she says. “You don’t get the full effect, but it’s better to do with one hand than not at all.”

Williams also suggests a “balance” mudra to re-center the body. With the hands resting on the belly, thumbs touching, place the back of the left hand in the palm of the right and breathe deeply. “This helps send lots of extra energy to the head through the fingers, helping to balance the brain,” she says,

Push and pull

Traffic congestion or other frustrations may lead some drivers to clench their jaw, which can lead to other problems. Donald R. Tanenbaum, DDS, MPH, co-author of Doctor, Why Does My Face Still Ache?, says, “Fatigued jaw muscles will likely lead to headaches in the temples, tightness or pain in the jaw muscles, limited jaw motion, ear pain and pain in the joints of the jaw itself.”

When that happens he advises truckers to place the tongue on the roof of the mouth, position a thumb or fist under the jaw and attempt to open your mouth. The resistance helps ease jaw tension and temple headaches. For neck tightness, he suggests pushing the forehead against the palm and holding. Repeating these exercises several times a day should help reduce accumulated pressure in the neck and head.

Stretches may also help untie knotted muscles. Scott Gottlieb, MD, director of pain management at New York Eye and Ear Infirmary in Manhattan, says, “Flexing your neck slowly side to side, and backwards and forwards, will relieve neck tension.” Do not roll your neck in one continuous circle — that can lead to injury.

For leg and back tightness, he proposes straight-legged ankle rolls to get the blood flowing again.

In the air

Stopping to smell the roses may induce appreciation for life, says Kelly Holland Azzaro, RA, CCAP, LMT, president of the National Association for Holistic Aromatherapy, but citrus scents are particularly helpful in dispelling stress. “Lemons, sweet orange and grapefruit help elevate your mood and relieve stress,” she says. She suggests putting a drop of diluted essential oil on a tissue and inhaling the aroma. “Or you could use a plug-in diffuser. The warmth sends the scent into the cab.”

While there’s no escaping stress, some simple remedies may keep you on course and in good health.

6 Questions Diabetics Should Ask Their Pain Management Doctor

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According to the American Diabetes Association, 8.3 percent of the United Statespopulation is living with diabetes. Dr. Scott Gottlieb of Gramercy Pain Management inNew York City offers his insight as to what diabetic patients should ask their doctor.

1.  How does diabetes cause pain?

The reason patients feel pain is because the diabetes attacks the small blood vessels which ultimately damage the nervous system. The pain that patients are feeling comes from the damaged nerves.

2. What are the symptoms of diabetes?

The symptoms of Type 1 diabetes include but are not limited to: increased thirst and hunger, dry mouth, nausea, abdominal pain, frequent urination, fatigue, heavy breathing and frequent infections of the skin and urinary tract. The symptoms of Type 2 diabetes a patient can experience are similar to Type 1 diabetes with the addition of possible blurred vision, numbness or tingling of the hands and feet and sores that are slow to heal.

3.  What kind of treatment is available to help with diabetic pain?

There is a wide array of medications available to try to help with diabetic pain such as Non-Steroidal Anti-Inflammatory (NSAIDS) pills like Aspirin and Advil. Anti-seizure drugs such as Lyrica or Nerontin are also available to help with pain because it can calm sensitive nerves. Along with NSAIDS and anti-seizure drugs, antidepressant medications can alleviate the pain as well. For patients who do not wish to take pills orally, there are also topical creams available.

4.  If I do not want to take pain medications, what other types of ways can pain doctors alleviate diabetic pain?

If the patient does not wish to take pain medications, the pain management doctor can work with the patient to come up with a diet/exercise regimen and a possible regimen of massage, acupressure, or biofeedback to help with the pain.

5. What non-traditional methods could help with diabetic pain? 

The non-traditional methods to help with diabetic pain include regimens of diet/exercise, massage, acupressure or biofeedback (a technique that trains people to improve their health by controlling certain bodily processes that normally happen involuntarily).

6. How can diet/exercise help with diabetes and diabetic pain?

It is important for a diabetic to always eat a balanced diet. Instead of choosing carbohydrates that consist of only white flour, eat whole-wheat, which are considered “slow-release” and “high-fiber” foods that benefit a diabetics health more than white flour. Also, patients think that when they have diabetes they have to avoid sugar at all cost. Wrong. Diabetic patients can eat sugar, but in moderation and not everyday. Exercise is just as important as maintaining a balanced diet. Any type of physical activity such as hiking, walking, biking and swimming can control diabetes.

About Dr. 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, New York in Rockland County.

Does Cannabis Sativa Help Multiple Sclerosis Patients?

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By Mikel Theobald
Medically reviewed by Pat F. Bass III, MD, MPH

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
• Fatigue
• Dry mouth
• Memory problems
• Blurred vision
• Increased anxiety or paranoia
• Respiratory problems
• Nausea
• Dizziness and loss of balance
• Numbness
• Hallucinations
• Flashbacks
• Depression
• 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.

Avoid the Emotional Pitfalls of Pain

By Wyatt Myers
Medically reviewed by Lindsey Marcellin, MD, MPH
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Coping with chronic pain is never easy. But for some, the day-in, day-out impact of living with pain can lead to a second assault — emotional issues like frustration, anxiety, and eventually depression. And poor emotional health can further exacerbate physical pain, leading to a worsening of physical symptoms.

“What happens in the mind and emotions affects the physical body and vice versa,” says Katherine Puckett, PhD, LCSW, the national director of mind-body medicine for the Cancer Treatment Centers of America.

“Feelings of anger, depression, and anxiety contribute to stress, which in turn has physical effects such as increased muscle tension, increased heart rate, reduced functioning of the digestive system, increased inflammation in the body, and increased activity in the sympathetic nervous system that results in release of stress hormones,” say Puckett. Any or all of these physical effects of stress may in turn increase pain. And increased pain may make a person feel more depressed. It can be a vicious cycle if you don’t interrupt it.

How Pain Impacts Emotional Health

Chronic pain doesn’t necessarily doom you to depression or other emotional problems, but pain does lead to some situations that can make emotional issues more likely, says Scott Gottlieb, MD, of Gramercy Pain Management in New York. “Someone who is in pain stays home, feels frustrated, and can’t do what they used to do,” he says. “This impact of pain on activities of daily living can cycle some patients into a depressive state.”

Anxiety in particular often occurs when there’s uncertainty about what’s causing the chronic pain, adds Dr. Gottlieb. “For example, if someone is having headaches and nothing shows up in any tests or studies, it’s often hard for a patient to accept it’s just nerve pain as a diagnosis,” he says. “They feel pain in their head all day and are anxious that it is something more serious even though other serious causes have been ruled out.”

Managing Chronic Pain Emotions

These strategies can help you break free from the spiral of emotional problems leading to even more pain:

  • Try counseling. Even if you don’t feel like you have full-blown depression or anxiety, a visit with a counselor can help stem the tide of pain-related emotions before they get worse. “A good therapist will listen, get to know the person, gain an understanding of what he or she is going through, and offer helpful reflections and suggestions,” says Puckett.
  • Exercise more. Puckett says regular exercise is one of the best antidotes to both emotional problems and pain. And it doesn’t have to be an intense exercise that might exacerbate your pain either. If your doctor approves, “taking walks, enjoying nature, or playing with pets are all good choices,” Puckett says.
  • Try deep breathing. Philip Wazny, NMD, a naturopathic medical doctor and pain specialist at Integrative Health Care in Scottsdale, Ariz., recommends a simple stress- and anxiety-reducing technique. “For beginners, taking as little as 10 minutes a day to focus on your breathing can be a game changer,” he says. “I recommend that people sit in a quiet space and focus on their breath. It sometimes helps to count to seven while inhaling, hold the breath for two seconds and then exhale for eight seconds. By exhaling for a little longer, patients are forced to use accessory muscles that cause a reflexive inhalation of healing oxygen.”
  • Write it down. “Patients may benefit from keeping a pain log to chart their symptoms,” says Anand Gandhi, MD, a physician at the Laser Spine Institute. “This allows you to monitor pain over time and objectively compare from one day to the next.”

Above all, keep a positive attitude. It may be difficult at times, but Dr. Gandhi says this is critically important to not falling into the depths of anger, depression, or emotional distress. “Chronic pain causes both emotional and physical changes in many patients,” he says. “It is important that patients maintain a positive attitude and avoid allowing the pain to consume their lives.”

Don’t Let Holiday Travel Be a Pain in Your Neck

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The holidays are around the corner and many of us will be travelling far distances to spend time with friends and family.  It is a joyous time of year but it is not without its stresses.  Whether driving or flying, travel pains and stresses can hinder holiday spirit.

Here are some tips to help reduce these troubles and make traveling more tolerable.

Driving:

Driving for long periods of time in the same position can strain the back, legs, and neck.  There are several simple stretches that can relieve the stress on the body and can be done while driving or during a brief stop.  Flex the neck slowly side to side and backwards and forwards to help relieve neck tension.  When stopped and your hands do not have to be on the wheel, raise one arm over your head, bend it, and grab the elbow with your other hand.  Pull the bent arm gently over your head to the side.  Alternate and repeat several times.  Also, when stopped and your foot can take a break from the pedals, stretch your leg straight and roll the ankle for several rotations.  Taking frequent short breaks and staying hydrated while driving will help relieve the physical stress of long-term sitting as well.

Flying:

Adding to the stress of travel may be the fear of flying.  It is possible for emotional pain to exacerbate any physical pain you may be feeling so it is important to address both. The stretches outlined for driving can also be effective in relieving muscle tension stemming from anxiety but paying attention to your breathing can relieve stress also.  Breathe deeply, inhaling through the nose and exhaling through the mouth.  With or without fear of flying, long flights can be restless and uncomfortable so be conscious to sit straight up with your shoulders back to prevent unwanted back aches.

Post-holiday pains?  Be sure to see a medical professional for any lingering pain to determine if this indicates a more serious issue.

About Dr. Scott Gottlieb:

Dr. Scott Gottlieb is 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. He has recently been featured on Yahoo! Health and Everyday Health.