Medicare to Cover Acupuncture in Pilot Program

By Pat Anson, PNN Editor

A week after a federal report documented a significant decline in opioid prescriptions among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has taken a tentative step to cover acupuncture as an alternative treatment for chronic low back pain.

Under a CMS proposal, patients enrolled in clinical trials of acupuncture sponsored by the National Institutes of Health (NIH) or in studies approved by CMS would be covered under Medicare’s Part D program. CMS has been collaborating with the NIH in studying acupuncture as a treatment of chronic low back pain in adults 65 years of age and older.

In a statement, CMS acknowledged that while “questions remain” about acupuncture’s effectiveness, interest in the therapy had grown in recent years as a non-drug alternative to opioids.  

Acupuncture is an ancient Chinese form of treatment that involves the insertion of fine needles into various points on the body to alleviate pain and other symptoms.

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“Chronic low back pain impacts many Medicare patients and is a leading reason for opioid prescribing,” said CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt. “Today’s proposed decision would provide Medicare patients who suffer from chronic low back pain with access to a nonpharmacologic treatment option and could help reduce reliance on prescription opioids.”

Currently, acupuncture is not covered by Medicare. CMS is inviting public comment on the proposal to gather evidence and help determine if acupuncture is appropriate for low back pain. Comments will be accepted through August 14.

“Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.” said Health and Human Services Secretary Alex Azar.

Spending on Opioids Peaked in 2015

Medicare Part D spending on opioid prescriptions has been falling for years. It peaked in 2015 at $4.2 billion and now stands at its lowest level since 2012, according to a report released last week by the HHS Office of Inspector General.

The decline in opioid prescriptions appears to be accelerating. Last year, 13.4 million Medicare beneficiaries received an opioid prescription, down from 14.1 million in 2017.

SOURCE: HHS OFFICE OF INSPECTOR GENERAL

SOURCE: HHS OFFICE OF INSPECTOR GENERAL

The Inspector General identified over 350,000 Medicare patients as receiving high amounts of opioids, with an average daily dose great than 120 MME (morphine milligram equivalent) for at least three months. The CDC opioid guideline recommends that daily doses not exceed 90 MME.  

The report highlighted the case of an unnamed Pennsylvania woman who received 10,728 oxycodone tablets and 570 fentanyl patches in 2018. Her average daily dose was 2,900 MME. She received all of her opioid prescriptions from a single physician.

The report said there were 198 prescribers who “warrant further scrutiny” because they ordered high doses of opioids for multiple patients.

“Although these opioids may be necessary for some patients, prescribing to an unusually high number of beneficiaries at serious risk raises concerns. It may indicate that beneficiaries are receiving poorly coordinated care and could be in danger of overdose or dependence,” the report found.  “Prescribing to an unusually high number of beneficiaries at serious risk could also indicate that the prescriber is ordering medically unnecessary drugs, which could be diverted for resale or recreational use.”

Under a new federal law, CMS is required to identify and warn “outlier prescribers of opioids” on an annual basis about their prescribing patterns. Medicare insurers could also require high-risk patients to use selected pharmacies or prescribers for their opioid prescriptions.

Do You Really Need Spine Surgery?

By David Hanscom, MD, PNN Columnist

In today’s medical environment, big business is taking over in almost every realm. The focus is on productivity, instead of ensuring the highest quality of care. For spine surgeons like myself, the revenue generators are procedures and “interventions” – even though most of them have been shown to be ineffective.

New technology has made the situation worse instead of better. The interventions are larger, more expensive and much riskier. You, the patients, have become targets and opportunities.

The last five years of my practice became increasingly intolerable. I would see several patients a week who had surgery performed or recommended on spines that didn’t have a surgical problem. I hit a tipping point when I saw an athletic older gentleman who had his spine fused from his neck to his pelvis for muscular thoracic pain after lifting weights. He went from playing tennis and golf to being housebound, on high-dose opioids and had a psychotic break.

He was fused in a crooked position and could no longer see his feet.  He had to undergo a second 12-hour surgery just to stand him up straight again.

His case was a significant factor in my decision to retire from my practice as a complex spine surgeon in December of 2018 to pursue educating the public as to the nature and extent of the problem, as well as present viable solutions.

Fusions Have Low Success Rate

Spine surgery works wonderfully well when there is a distinct identifiable anatomical abnormality and pain is in the expected region of the body. However, surgery works poorly if the source of pain is unclear.

There is a widespread belief among patients and many physicians that when everything else has been tried and failed, then surgery is the next logical step. Nothing could be further from the truth.

Defining the correct anatomical problem to surgically treat is problematic. One of the most glaring examples of blindly proceeding with surgery in spite of the evidence is performing a fusion for low back pain (LBP).

It is well-documented that disc degeneration, bone spurs, arthritis, bulging discs, etc. are rarely the cause of LBP. Often, we really don’t know where the pain might be arising.

The success rate of fusions for LBP is less than 30%.  Most people expect a much better outcome and the resulting disappointment is problematic.

Another major problem is that when a surgical procedure is performed in a person with chronic pain in any part of the body, he or she may experience chronic pain at the new surgical site between 40 and 60% of the time. Five to ten percent of the time, the pain is permanent.

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Many patients have told me undergoing spine surgery was one of the worst decisions of their life: “If I just knew how bad this could be, I never would have done it.”

Consider what happens when you go to the dentist with a painful cavity that may require a root canal, crown or extraction. There is a defined problem, and the pain will usually disappear once the problem is solved.

But what if you had gum disease or jaw pain, and a tooth doesn’t appear to be the source? Would you let your dentist randomly work on different teeth to see if it might help?

Making an accurate diagnosis of the problem is always the first step in solving it. 

Understanding the Whole Picture

Chronic pain is a complex problem that requires time and a multi-pronged approach to treatment. Current neuroscience research has unlocked the puzzle of chronic pain and it’s a solvable problem using the correct paradigm. But in the current medical climate, surgeons are being asked (and pushed) to move too quickly, and not factor in all of the variables that affect pain and surgical outcomes.

One 2014 research paper reported that only 10% of orthopedic spine surgeons and neurosurgeons are addressing and treating the well-documented variables in patients that predict poor outcomes. For example, one common problem for patients is lack of sleep. A large four-year study out of Israel demonstrated that insomnia induces low back pain. If a patient is sleep-deprived for just one night, his or her pain tolerance drops dramatically.

There are two sets of variables to consider when deciding whether to undergo spine surgery.

1) Your anatomy:  Has your doctor used an MRI or diagnostic test to identify the anatomical problem? If there isn’t a clearly identifiable source of pain, then surgery isn’t an option, regardless of how much pain you are experiencing.

2) Your nervous system and body chemistry:  Are you calm? Or are you stressed and hyper-vigilant? If your nervous system is on “high alert” for any reason, the outcomes of surgery are predictably poor, especially if you can’t identify the anatomical problem.  

If you are stressed, there are simple, consistently effective measures that can calm your nervous system and help you become pain free, often without surgery.

We already have the knowledge and technology to offer superb care and much of the data is being ignored. Whatever you decide to do or what resources you might use, don’t jump into spine surgery until you understand the whole picture. It may be the biggest decision of your life. 

David+Hanscom.jpg

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

New Safety Concerns for Osteoarthritis Drug

By Pat Anson, PNN Editor

Disappointing results from a Phase 3 clinical study are raising new safety concerns about an experimental class of pain-relieving drugs once considered a promising alternative to opioids.

Pfizer and Eli Lilly say 6.3% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive osteoarthritis in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis.

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“We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” Ken Verburg, Pfizer Global Product Development, said in a statement. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the brain.

Tanezumab was considered so promising a therapy that it was given fast track designation from the FDA in 2017, a process that speeds up the development of new therapies to treat serious conditions.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of concerns that tanezumab made osteoarthritis worse in some patients. Most clinical studies of tanezumab did not resume until 2015.

The reappearance of the same safety issue and the marginal pain relief provided by tanezumab could be the last straw for the drug, according to one analyst.

“It is hard for us to imagine how these results could have been much worse. Pfizer indicated that they ‘plan to review the totality of data’ with regulatory authorities, which suggests to us that the co-sponsors will try to find a way to resurrect the program for some subset or sub-population of patients, but recognizes that this result puts the drug’s entire future in doubt,” SVB Leerink research analyst Geoffrey Porges said in a note to clients.

A clinical study of fasinumab, another NGF inhibitor being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA in 2016 after a patient showed signs of severe joint disease. Regeneron and Teva are continuing to study fasinumab in patients with chronic low back pain.

Pfizer and Eli Lilly are also studying tanezumab as a treatment for low back pain, and reported promising results from a Phase 3 trial in February. Rapidly progressive osteoarthritis was also reported in a small number of patients involved in that study.

Epidural Steroid Injections Won’t Solve Your Back Pain

By David Hanscom, MD, PNN Columnist

A lawsuit was in the news recently about a Kentucky doctor who refused to give his patients pain medication unless they had epidural steroid injections.

Really? I have run across this scenario many times throughout my 32 years of performing complex spine surgery. It is a huge problem from several perspectives.

First of all, epidural steroid injections don’t provide lasting relief for any indication. This is particularly true when they are recommended for neck or back pain. There is not any research paper indicating a significant benefit. Yet they continue to be administered at a high rate.

I prescribed them sparingly for acute ruptured discs, where the natural history is for them to resolve without surgery most of the time. The steroids do knock down the inflammatory response that occurs around the disc material, so it buys some time and sanity while the body heals.

I also used them occasionally for spinal stenosis (constriction of the nerves). Pain in the arms and legs would usually improve for a short period of time.

What was unexpected was that many patients that I had on the schedule for surgery would cancel because their pain would disappear when they utilized other tools to calm down the body’s stress hormones. The more favorable hormone levels changed their pain threshold.

Epidural steroid injections as a stand-alone treatment might be of some benefit, but they aren’t going to definitively solve your chronic pain. Whatever benefit that a patient may feel probably comes from the systemic effects of the drug. Steroids make everything feel better, but it’s unfortunate that there are so many severe side effects.

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Let me share what happened to one patient.

Ralph was one of my favorite patients. I worked with him for over 20 years. I haven’t met a more well-intentioned human being. By the time I first met him, he had undergone over ten surgeries and was fused from his neck to his pelvis. He never had relief from his chronic back pain. I had to perform a couple of major surgeries just to get him standing up straight.

I worked hard with Ralph on a structured rehab approach with some modest success. I lost track of the number of phone calls. He had a lot of stress at home and was helping to raise a grandchild. In spite of his pain, he kept moving forward.

Then he broke through and had a dramatic decrease in his pain and better function. Ralph wasn’t pain free and his function was permanently limited because his spine was fused. But he was stable on a relatively low dose of opioids. We were both pleased.

I didn’t hear from Ralph for many years until he called me from his local hospital. He was quite ill. His entire spine was severely infected. His primary care physician, who took care of his meds, had retired. No one else would take care of his needs and he was referred to a local pain clinic, which performed a high volume of spinal injections. They would only prescribe opioids if Ralph agreed to the injections.

Not only are injections ineffective for back pain, they really don’t work in the presence of 12 prior surgeries. Ralph’s back was a mass of scar tissue, rods and bone without much of a nerve supply. There is also less blood supply in scar tissue and a much higher chance of infection. Where would you even place a needle if the whole back is fused?

We admitted Ralph and had to open up his whole spine, which was infected with several hundred milliliters of gross pus. It took another two operations to wash him out and get the wound closed. He eventually did well, and we continue to stay in touch.

Ralph had to undergo a proven ineffective procedure in a high-risk setting in order to obtain pain medications that were effective. He became seriously ill, underwent three additional surgeries with the attendant pain and misery, and the cost to society was over a hundred thousand dollars. I rest my case. 

David+Hanscom.jpg

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Are Sit-Stand Desks Overrated?

By Pat Anson, PNN Editor

You’ve probably seen commercials touting the health benefits of sit-stand desks. Experts say being able to stand occasionally – instead of sitting at an office desk all day -- helps prevent back pain, diabetes, high blood pressure, obesity and other chronic health conditions.

There may be some truth to that, but some of the health claims range from silly to the absurd.

“Sitting is more dangerous than smoking. We are sitting ourselves to death,” James Levine, MD, an endocrinologist at the Mayo Clinic, told the Los Angeles Times. “The chair is out to kill us.”

Is sitting really that dangerous? It is if you believe Australian researchers, who came to the eye-opening conclusion that sitting for one hour reduces life expectancy by 22 minutes. Their study was about people who watch a lot of television, but it is often cited by sit-stand desk manufacturers.

One desk manufacturer funded a study — which is mysteriously being promoted by the CDC — that looked into the psychological benefits of sit-stand desks. The study found that standing more often at work will not only relieve back pain, but make you feel healthier, happier and improve your self-esteem.

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Minimal Health Benefits

Just how reliable is this industry-promoted research?

“There has been a great deal of scientific research about sit-stand desks in the past few years, but we have only scratched the surface of this topic,” says April Chambers, PhD, an assistant professor of bioengineering at the University of Pittsburgh’s Swanson School of Engineering. “I wanted to gather what we know so far and figure out the next steps for how can we use these desks to better benefit people in the workplace.”

Chambers and her colleagues reviewed 53 studies on sit-stand desks and published their findings in the journal Applied Ergonomics. Their research focused on the impact of the desks on behavior, physiology, psychology, work performance, discomfort and posture.

“The study found only minimal impacts on any of those areas, the strongest being changes in behavior and discomfort,” said co-author Nancy Baker, ScD, an associate professor of occupational therapy at Tufts University.

“There are health benefits to using sit-stand desks, such as a small decrease in blood pressure or low back pain relief, but people simply are not yet burning enough calories to lose weight with these devices,” added Chambers.

One of the biggest flaws in current studies is that most were done with young and healthy subjects who were asked to use the desk for a week or month at most. Researchers say it would be beneficial to perform longer studies with middle-aged or overweight workers to get a more accurate measure of the desks’ impact on cardiovascular health and weight loss.

Further study is also needed on desk height, monitor height, the amount of time standing, and the use of anti-fatigue floor mats to soften the blow of so much standing. 

“There are basic ergonomic concepts that seem to be overlooked,” said Chambers. “Many workers receive sit-stand desks and start using them without direction. I think proper usage will differ from person to person, and as we gather more research, we will be better able to suggest dosage for a variety of workers.”

Sit-stand desks range in price from inexpensive models for $179 to nearly $1,000 for motorized adjustable desks that come with settings for different users.

If you’re thinking of buying a sit-stand desk, a good place to start your research is online. In the YouTube video below, David Zhang rates some of desks he’s tried over the past year. David likes having a standing desk, but has doubts about their health benefits and says the desks do not replace the need for a good old-fashioned office chair.

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

Opioid medication significantly reduces low back pain, but opioids should not be used in combination with gabapentin (Neurontin) because of their limited effectiveness and potential for abuse, according to the authors of a small new study presented at the annual meeting of the American Academy of Pain Medicine.

"In these days, when we are focusing on reduction of opioids due to opioid crisis in the U.S., gabapentin could be an important part of multimodal non-opioid pain management," N. Nick Knezevic, MD, of the University of Illinois in Chicago told MedPage Today. "However, it should not be given to all patients since the effectiveness in chronic pain patients, particularly in those with low back pain, is limited."

KAISER HEALTH NEWS

KAISER HEALTH NEWS

In a retrospective study, Knezevic and his colleagues looked at 156 patients with low back pain; half of whom were treated with opioids alone and the other half with a combination of opioids and gabapentin.

“According to our study, the combination of gabapentin with opioids was not statistically superior in providing pain relief, in contrast to opioids alone, in patients with chronic pain. Our results are in line with recent guidelines for low back pain treatment that reflect the need to assess the recommendation of gabapentinoids for chronic pain in patients already taking opiods to mitigate risk factors of abuse and overdose,” researchers found.

Gabapentin is an anticonvulsant that was originally developed as a treatment for epilepsy, but is now widely prescribed for a variety of chronic pain conditions. Its use in primary care as a treatment for chronic back and neck pain has risen by 535% in the last decade, despite little evidence of its effectiveness.

"The fact that anticonvulsants are often advertised to be effective for 'nerve pain' may mislead the prescriber to assume efficacy for low back pain or sciatica," Oliver Enke, MD, of the University of Sydney, told MedPage.

A 2018 study by Australian researchers found that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea. Another recent study found that combining gabapentin with opioid medication significantly raises the risk of dying from an overdose than opioid use alone.

There have been increasing reports of gabapentin being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

The CDC’s opioid prescribing guideline recommends gabapentin as a safer alternative to opioids, without saying a word about its potential for abuse or side effects.

A 2017 commentary in the The New England Journal of Medicine warned that gabapentinoids -- a class of nerve medication that includes both gabapentin and pregabalin (Lyrica) -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."

New Non-Opioid Drug Effective in Treating Low Back Pain

By Pat Anson, PNN Editor

Pfizer and Eli Lilly have announced positive results from a large Phase 3 study evaluating an experimental non-opioid pain reliever as a treatment for chronic low back pain.

Patients receiving 10 mg injections of tanezumab showed statistically significant improvement in back pain at 16 weeks compared to placebo. A lower dose of tanezumab 5 mg was not as effective. Over 1,800 people with chronic low back pain in North America, Europe and Asia participated in the study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines," said Ken Verburg, Pfizer’s tanezumab development team leader.

“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

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Pizer and Eli Lilly have also reported positive findings in evaluating tanezumab for the treatment of osteoarthritis. The Food and Drug Administration granted “fast track” designation to tanezumab in 2017 to help speed its development.

Tanezumab has a history of safety concerns. Clinical studies were halted in 2010 after Pfizer reported some osteoarthritis patients receiving the drug had worse symptoms and needed joint replacement surgery. Another safety issue arose in 2012 when tanezumab caused adverse changes in the nervous system of animals.  Most clinical studies of tanezumab did not resume until 2015.

In the current study, rapidly progressive osteoarthritis (RPOA) was observed in 1.4 percent of patients receiving tanezumab and 0.1 percent of patients in the other treatment groups. Joint fractures and total joint replacements were experienced in 0.4 percent and 0.7 percent of tanezumab-treated patients, respectively, while none were observed in the other treatment groups.

In addition to back pain, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis pain and cancer pain due to bone metastases.