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See the new portal at http://portal.painchicago.com
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McGuireWoods’ forthcoming 13th Annual Healthcare and Life Sciences Private Equity & Finance Conference will be held on Tuesday, February 23rd and Wednesday, February 24th, 2016 in Chicago, IL.
The session will be held in the Ritz-Carlton at 160 East Pearson Steet in the Water Tower Place. The session will start at 10:15 and last 45 minutes.
The presentation will be about key issues and opportunities in pain management and anesthesia. Steven Aguiar of Provident Healthcare Partners, LLC will be moderating.
Steroid Injections: Are They Worth the Risk? Amid controversy surrounding the U.S. fungal meningitis outbreak, opinions are split on how effective steroid injections are for treating chronic back pain.
Steve D’Alise, a 40-year-old financial analyst in Chicago heard about the deaths from fungal meningitis related to steroid injections for pain. But his back pain is so severe, he opted to have his steroid injections anyway.
“When it gets really bad it consumes you,” says D’Alise of the sciatica thats plagued him since 2009.
News of the fungal meningitis outbreak that has killed 12 has shone a spotlight on a lesser-known but frequently used fix for one of the most common chronic conditions in the United States: back pain. But medical experts and a large body of research call into question the efficacy of steroid injections, calling them a risky and costly treatment.
What makes this entire tragedy ironic is the poor evidence that these steroid injections would have relieved their back pain in the first place, says Fabrizio Mancini, a certified chiropractor, wellness expert, and the president of Parker University in Dallas.
Mancini points to a large body of research, including an editorial in the 2011 issue of the British Medical Journal. Epidural steroid injections have been used for more than 50 years to treat low back pain and are the most common intervention in pain clinics throughout the world, the article reads. Yet despite their widespread use, their efficacy is unclear. Of around 35 controlled studies evaluating such injections, slightly more than half show some benefit.
Patients like D’Alise have typically tried several interventions include ibuprofen, chiropractic care, physical therapy, and lifestyle changes before resorting to the injections. D’Alise says his condition makes commuting to work, riding a train, and sitting for long periods incredibly difficult. He received his last shot in 2011 but the relief only lasted for six months. He says the pain has returned to a “7” on a scale of one to 10.
D’Alise sought care from Scott Glaser, MD, an interventional pain-management specialist at the Pain Specialists of Greater Chicago. Even in the wake of the meningitis outbreak, Dr. Glaser says hes still administering some 18 steroid injections on a busy day. But now the doctor has found he must take some time to reassure his patients that the treatments are safe and worthwhile.
Most get relief from the local anesthetic which is mixed with the steroid and then the pain returns later that day, and the depot steroid starts to work in a few days, says Glaser. Typically, the maximum benefit will be obtained anywhere between 7 to 14 days.
Back Pain a Growing Epidemic
Eight in 10 people will experience back pain in their lifetime, and steroid injections have become a gold standard treatment for acute and chronic pain because they’re fast acting, non-addictive, and minimally invasive.
“Back pain is a big, big problem,” says David Maine, MD, director of the Center for Interventional Pain Medicine at Mercy Medical Center in Baltimore, Md. “It’s a difficult thing to treat. You sometimes make decisions quickly just to get meaningful relief.”
Dr. Maine says his practice typically uses steroid injections as “an intermediate treatment” when physical therapy, chiropractic therapy, and over-the-counter inflammatory medications, such as ibuprofen, are not effective. The injections are often one of the last intervention therapies before a patient considers surgery. Steroid injections are also a much safer alternative to many pills doctors might prescribe for pain, including highly addictive opioids and narcotics.
The U.S. Centers for Disease Control yesterday reported 137 cases of meningitis in 10 states with 12 deaths from the infection from methylprednisolone acetate injections.
Steroid injections can be costly. Glaser says they can cost $2,000 to $3,000 for each injection. “Our routine treatments are typically covered by insurance but it is getting more difficult in a lot of cases as the insurance companies deny or delay more and more treatment,” he explains. He added some insurance companies may pick up only 20 percent of the cost of such an injection.
Medical expenses for individuals with spine problems average $6,096 compared with $3,516 for patients without them, according to a 2008 analysis by the Journal of the American Medical Association using government data. From 1997 to 2005, the estimated expenditures among patients with spine problems increased 65 percent, the analysis said.
No Hard and Fast Rules for Treating Back Pain With Steroids
Pain specialists say the number of injections needed to stop back pain varies from patient to patient. “Some may have one or two and then they go through the natural healing process,” says Dr. Maine. “Others with chronic back pain or acute pain may get two or three over the course of eight months. There are no hard and fast rules. It just needs to be done for the right indication.”
Methylprednisolone acetate, the medication that was administered to patients who contracted fungal meningitis, is one of four types of corticosteroids for injections. A corticosteroid is an anti-inflammatory hormone that reduces swelling in muscle and soft tissues, and is also naturally produced in the body. The hormone is physiologically essential for stress and immune response, as well as metabolic functions. The steroids work by calming nerves and reducing the release of certain bio-transmitters, such as substance P and bradykinin, which decreases pain.
The relief from injections most typically lasts around six months to one year. However, many patients report they’ve been cured of back pain after receiving just one or two injections.
Scott Glaser, MD, is a director on the national board of the American Society of Interventional Pain Physicians, where he has also served as vice president. He is heavily involved with the group’s lobbying and advocacy efforts for the practice of interventional pain management, and here he discusses the field’s most pressing issues and problems.
Q: What has been the focus of ASIPP’s advocacy efforts this year?
Dr. Scott Glaser: The main focus of our legal efforts this year has been fighting recent actions by the Centers for Medicare & Medicaid that are classic bureaucratic decisions made in a vacuum without knowledge of consequences. CMS is stating that we need to use single dose vial for each patient of all medications we inject, including steroids, contrast, and local anesthesia. They are doing this based on a few anecdotal reports of infections following injections. There is no science behind this. It is an inappropriate, over-reaching governmental response to a problem. In each of the anecdotal cases, there was evidence that appropriate sterile technique was not followed. The complications were terrible, but there is no evidence that using single dose vials would have prevented those cases. Also, there is no supportive scientific evidence that using a single dose vial will prevent infection. It is just not in the literature. In the anecdotal cases that have led to this recommendation, infections are just as likely to have occurred had single dose vials been utilized. Lastly, there is no evidence that single dose vials which are used in multiple patients are a cause of infection, if you use the proper infection control. It is really an insult to physicians and nurses who have been performing these procedures for years using safe technique.
Q: What problems could result from this regulation?
SG: This practice of using only single dose vials for each patient will lead to a shortage of drugs that are already in short supply. It will lead to incredible waste. The contrast is bio hazardous and more of it will be thrown away. The greatest consequence will be a reduction in access to care secondary to the cost of supplies. The estimated cost of implementing this will be each procedure costs $80 more, and that is a huge number. This will lead many practices to stop performing these procedures and many ASCs and hospital outpatient departments to disallow them thereby reducing access to care.
Q: What are you and ASIPP doing to fight the regulation?
SG: We are educating our legislators. Many have already written letters or signed on to letters to CMS stating this is a bureaucratic error where they don’t understand the whole situation. Prior to making this decision CMS consulted an infectious disease group and some other parties but they didn’t consult people actually doing the procedures. Hopefully that decision will be overturned.
Q: What are other pressing issues in the pain management field?
SG: Another significant issue for us right now deals with certified registered nurse anesthetists. CMS in the affordable healthcare act is proposing a policy where CRNAs would be reimbursed and allowed to perform interventional pain management procedures. We strongly oppose this. The practice of interventional pain management is the practice of medicine and should only be practiced by appropriately trained physicians. The training for a CRNA does not include any training in pain management. Their schooling consists of providing anesthesia IV sedation for surgical and other procedures. There is no formal training of any kind regarding the diagnosis and treatment of patients suffering chronic pain. There is also no formal training regarding the provision of interventional procedures for chronic pain using diagnostic and therapeutic image guided interventional techniques, which have significant risks that are materially different than the risks of procedures used to provide anesthesia in the OR. Even in well trained and experienced hands severe complications continue to occur because of the nature of this field.
Q: What do you think is the reason for this ruling?
SG: They are basing the reasoning on two flawed ideas or assumptions. They think it will save money because nurses are treating patients, not doctors, when actually it will have the opposite effect. If CRNAs will be allowed to bill, they will bill the same amount physicians do for consults and procedures. There is no special fee schedule for nurses. With more procedures on more patients that will increase the cost of care. It’s also based on the flawed assumption that there is a lack of access to care for pain management procedures. We have no evidence of that. In Illinois they’ve done studies that show the farthest drive is 75 miles for access to pain management services provided by a physician.
Lastly, the treatment of chronic pain with opioids and other controlled substance by inadequately trained doctors has led to an epidemic of prescription drug abuse and accidental poisoning. The training of CRNAs does not include training in this complex area and will expose chronic pain patients to more providers without the appropriate knowledge and training to treat them with the powerful medications. This will further exacerbate this already tragic problem.
Q: What problems do you see with the practice?
SG: This practice raises several concerns. One is public safety. These procedures are minimally invasive but they are maximally dangerous. The number of people becoming quadriplegic or dying is increasing even when they are performed by doctors who are specifically trained in interventional pain management. In other words, if these complications may occur to a well trained doctor, then one can only imagine the increased incidence with inadequately trained CRNAs. It is truly a frightening concept to those of us practicing and board certified in interventional pain management.
Two, it’s a fraud and abuse issue. Pain management issues are already tainted because they are over utilized by some members of the medical profession. Fraud will only get worse when more providers are reimbursed for these procedures. This is especially true when those providers are untrained and don’t have the knowledge to perform the procedures in the appropriate algorithmic fashion get the maximum benefit. Lastly, the treatment of pain with opioids by physicians not trained appropriately has led to an epidemic of prescription drug abuse and accidental poisoning. This phenomenon will only be exacerbated by allowing another group of providers without appropriate training to provide and be reimbursed for the treatment of chronic pain.
Q: Have you made any progress in contesting the decision?
SG: The provision of these services will be decided on a state-by-state basis. There was a court case in Louisiana in which ASIPP and specifically current president Dr. Frank Falco and CEO Dr. Lax Manchikant was intimately involved and gave direct testimony which set an important precedent. The judge declared after long trial that CRNAs could not practice pain management and that interventional pain management was the practice of medicine. In addition, ASIPP members across the country are actively involved in educating their legislators about this issue.
Q: What other advocacy actions are you currently taking?
SG: The biggest thing was the ASIPP yearly meeting in June. After our scientific meeting, we had visits arranged with legislators from every state represented by interventional pain management physician. This issue was one of the specific issues we discussed with the legislators and their aides. We also have a letter writing campaign for many of our offices. We and our staff send letters to legislators, and we instruct our patients about these issues and have patients send letters as well. We support our leadership at ASIPP who are talking to legislators more often. The fact is, when it comes to some of these issues, we can’t go straight to CMS; we have to inform a legislator who then brings it to CMS’ attention to get it changed. Importantly, more and more legislators are being elected to Congress who have medical backgrounds. The legislators and the aides who are the most helpful, who really get it and understand the gravity of the issues, and who take an interest in pain management, have family members or friends who have required the services of a pain management doctor. They realize being a physician and being in pain management is extremely difficult these days. They understand the importance of training in the provision of these services, and they are grateful for what interventional pain management physicians do.
The American Society of Interventional Pain Physicians (ASIPP) had released its Opioid Guidelines for Responsible Prescribing in Chronic Non-Cancer Pain. As part its professional journal, the Pain Physician, ASIPP has created and revised guidelines for interventional techniques and opioid prescribing since 2002. The latest guidelines released today are comprehensive is a product of a multidisciplinary panel of 55 authors. These guidelines illustrate a 10-step process with comprehensive assessment and documentation, establishing medical necessity and treatment goals, recommendations for responsible opioid therapy with dose limitations, and necessity for a comprehensive and robust agreement. The guidelines include the initial steps for comprehensive assessment, including the risk assessment, steps to appropriate diagnosis, establishing medical necessity, establishing treatment goals, assessing effectiveness of opioid therapy; with informed decision making, initial treatment steps, adherence monitoring, evaluation of side effects and discontinuation or maintenance of opioid therapy on a long-term basis. It also covers the means and ways to initiate opioid therapy, specific guidelines for methadone use, and reduction in prescription drug dose.
These comprehensive two-part guidelines provide guidance on dose limitations with low dose being defined as 40 mg, moderate dose, up to 90 mg of morphine equivalence, and high dose as anything over 90 mg of morphine equivalence.
The following pain management physicians were selected for this list based on the awards they received from major organizations in the field, leadership in those organizations, work on professional publications and positions of service held at hospitals and surgery centers. The surgeons are listed in alphabetical order by last name. All physicians placed on this list have undergone substantial review from our editorial staff. Physicians do not pay and cannot pay to be selected as a great leader to know. The list is not an endorsement of any individual’s or organization’s clinical abilities.
Scott Glaser, MD (Pain Specialists of Greater Chicago, Chicago). Dr. Glaser is a director on the national board of the American Society of Interventional Pain Physicians, where he has also served as vice president. He has been the president of the Illinois Society of Interventional Pain Physicians and is a diplomate with the American Board of Interventional Pain Physicians. In addition to his practice, Dr. Glaser has been one of the first physician instructors of the International Spinal Interventional Society, where he provided training in performing spinal injections. He also instructs other physicians in minimally invasive spinal procedures in national cadaver courses. During his career, Dr. Glaser has been involved in lobbying for the passage of the NASPER bill fighting prescription drug abuse. Dr. Glaser earned his medical degree from Indiana University School of Medicine and completed his residency and fellowship in anesthesiology at Northwestern University Medical School in Chicago.