Almost all physicians write prescriptions, and each prescription requires a physician to assess the risks and benefits of the drug for their patient. If an adverse drug reaction occurs, physicians may be called on to defend their risk-benefit assessment in court.
The assessment of risk is complicated when there is a black box warning that describes potentially serious and life-threatening adverse reactions associated with a drug. Some of our most commonly prescribed drugs have black box warnings, and drugs that were initially approved by the FDA without black box warnings may have them added years later.
One serious problem with black box warnings is that there are no reliable mechanisms for making sure that physicians are aware of them. The warnings are typically not seen by physicians as printed product labels, just as physicians often don't see the pills and capsules that they prescribe. Pharmacists who receive packaged drugs from manufacturers may be the only ones to see an actual printed black box warning, but even those pharmacists have little reason to read each label and note changes when handling many bulk packages.
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CGS has released its final policy for epidural injections for pain management.
This will be effective December 5, 2021. Please check your individual MACs.
While this is a nationwide policy, we are seeing some discrepancies with the various policies. Some have a limit of four (4) epidurals per region and others are stating a limit of four (4) for all regions. We will clarify this soon, but it appears to be four (4) per region.
However, it also says that after the first treatment, a patient must have 3 months of ≥ 50% relief. If that is not achieved, a second procedure may be performed after 14 days using a different approach after appropriate documentation, which is very difficult.
Diagnostic codes do not include disc displacement and disc degeneration. All in all, the policy is extremely difficult to live with, not only for diagnostic coding, but for limitation of procedures limited to 4 per year for all regions combined.
Other issues also include in reference to documentation of at least 2 fluoroscopic views, pre and post pain levels each time.
There are some changes as per the request of ASIPP and other societies in reference to the definition of inclusion criteria:
- This now includes radicular pain, severe degenerative disc disease, and post laminectomy syndrome.
- An objective pain scale or functional assessment must be performed at baseline and repeated at each follow-up for assessment of response.
- Pain duration of at least four (4) weeks, and the inability to tolerate noninvasive conservative care or medical documentation of failure to respond to four (4) weeks of noninvasive conservative care.
- Only one spinal region may be treated per session.
ASIPP is hosting a webinar, New LCDs for Epidural and Facet Joint Interventions: An Algorithmic Approach to Documentation of Medical Necessity and Indications, to provide an in-depth explanation of the changes within these LCDs. Dr. Laxmaiah Manchikanti will give the 90-minute presentation, which will be followed by a 30-minute Q&A with panelist, Amol Soin, MD; Sairam Atluri, MD; Annu Navani, MD; and Chris Gharibo, MD. The cost of the webinar is $175 and will provide you with 2 AMA PRA Category 1 CreditsTM
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The NYU Grossman School of Medicine is surveying pain medicine fellowship graduates' perception of their training and level of preparedness for entering the practice of pain medicine. The survey committee is comprised of Christopher Gharibo, MD; Krupali Chokshi, MD; Gopal Desai, MD; and Lisa Doan, MD. Their goal is to publish information on which areas fellowship graduates feel most prepared and where needs are unmet that can provide constructive feedback to fellowship programs and ACGME. IRB approval has been obtained for the survey and all responses will be completely anonymous.
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Infections, hospitalizations and deaths decline in most states; ‘We may be at a turning point’
The Delta wave of the COVID-19 pandemic is past its peak, with new cases, hospitalizations and deaths declining in most states. The approaching holidays and winter months will test whether the U.S. can sustain that momentum.
New COVID-19 case numbers in the U.S. are close to levels recorded near this time last year, with a seven-day average at about 72,000 a day, Johns Hopkins University data show. But the trajectory is opposite. Last fall, cases were rising while hospitalizations and deaths, trailing indicators, were starting...
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A review of the evidence to date offers context for FDA's review of e-cigarettes
While most agree that quitting cigarette smoking is important, there is disagreement on the best approach to achieve this. After a landmark Surgeon General report came out in 1964 warning of the dangers of smoking, the search for alternatives began. For some, this included working with the tobacco industry to develop a "safer" nicotine product. The first attempt to get a "safer" cigarette led to the debacle that was "light" cigarettes (proven to be no more safe than traditional cigarettes), and today, the harm reduction focus is now on switching to "safer" e-cigarettes, also known as vaping products.
Following a court mandate for a public health review of vaping products, the agency recently granted marketing approval for RJ Reynolds Vapor Company's Vuse Solo e-cigarette -- the only e-cigarette approved so far. The agency concluded that the manufacturer's data suggested this product may benefit adult cigarette smokers who switch to these e-cigarettes by reducing their exposure to the harmful chemicals in traditional cigarettes.
But aside from the manufacturer's data, what does the scientific evidence say about e-cigarettes and cessation? Since 2007, e-cigarettes have been marketed in the U.S., where we have excellent surveillance systems to identify trends in smoking. Perhaps the best of these systems is the FDA-funded Population Assessment of Smoking and Health (PATH) Cohort Study (launched in 2013). Below, I answer a few relevant questions based on an evaluation of the data and trends in the PATH studies in order to contextualize FDA's current review of e-cigarettes.
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Nurses at Saint Vincent Hospital in Massachusetts say they won't leave "one nurse behind"
In a record-long strike approaching 8 months, nurses at Tenet Healthcare's Saint Vincent Hospital in Worcester, Massachusetts said a return-to-work agreement is now the sole issue standing in the way of its end.
The strike started in March, after nurses at the hospital alleged unsafe staffing practices. In August, the Massachusetts Nurses Association (MNA) said that the nurses agreed to staffing improvements negotiated during the strike and were ready to return to work to provide care. However, an end to the strike was scuttled over a return-to-work agreement put forth by the hospital.
According to the agreement, more than 100 of the nurses on strike may not be able to return to the exact same positions they left, a move the MNA called retaliatory in nature.
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Despite impending regulations, surprise billing still happens
One day in March 2020, during the height of the pandemic, Melinda Wenner Moyer's daughter, Jojo, fell off her bike in the driveway and cut her forehead on a rock.
After a quick consult with their primary care doctor, who said the 5-year-old needed stitches, and a trip to a nearby urgent care, which didn't think they could do the procedure without scarring, the mother and daughter set out for the emergency department. It was a 40-minute drive away, in Westchester, New York.
They went to the Maria Fareri Children's Hospital's emergency room. Moyer requested an on-call plastic surgeon, because someone had advised her to do so in a situation that called for stitches.
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The FDA granted orphan drug status to Soin Therapeutics for an investigational formulation of low-dose naltrexone as a treatment for complex regional pain system (CRPS).
Naltrexone is primarily used to manage alcohol or opioid use disorder [OUD] by reducing cravings or feelings of euphoria associated with substance use disorder. “It has also been shown in anecdotal reports to alleviate symptoms stemming from CRPS at very low doses (approximately one-tenth the dose for OUD) of currently approved indications,” according to Soin Therapeutics, in a press release. “When the dose of the drug is substantially lowered, the pharmacological effects change favorably to treat CRPS.”
Currently, Soin Therapeutics is developing its own novel formulation of low-dose naltrexone, and is in the process of preparing an Investigational New Drug Application meeting with the FDA as a needed step to commence a large, multicenter, national clinical trial.
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Pain Medicine Case Reports (PMCR) and Editor-in-Chief Alaa Abd-Elsayed, MD, PhD would like to invite you to submit case reports and case series to the PMCR journal. Your article will be published free of charge.
Open access journals are freely available online for immediate worldwide open access to the full text of published articles. There is no subscription fee for open access journals. Open access journals are no different from traditional subscription-based journals: they undergo the same peer-review and quality control as any other scholarly journal.
Interested in becoming a member of the PMCR Editorial Board?
Editorial board members are asked to review 2-6 manuscripts per year. Please submit your most up-to-date CV to sgold@asipp.org for consideration.
For more information or to submit your articles, click here.
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| CASE REPORT |
Ashley C. Wetzig, MD, and Krishna B. Shah, MD
Abstract
Background: Ankylosing spondylitis (AS) affects men more than women and commonly results in chronic back pain with spine and sacroiliac joint involvement.
Case Report: The patient is a 53-year-old man with a 25-year history of worsening AS. After not responding to available conservative therapies and not qualifying for back surgery, the patient underwent a 10-kHz high-frequency spinal cord stimulation (HF10 SCS) trial. After a successful trial without complications, permanent implantation was pursued with subsequent one-week postoperative outcomes demonstrating Visual Analog Scale score reductions of 87.5% in back pain and 50% in leg pain, an Oswestry Disability Index score decrease of 83%, and overall improvement in previously problematic health concepts on the EuroQol-5 Dimensions-3 Levels and 36-Item Short Form version 2 surveys.
Conclusions: This report highlights the successful use of Senza’s SCS system applying Nevro’s HF10 therapy in a patient with refractory symptoms of AS, highlighting potential applications of this technique which have yet to be studied.
Key words: Ankylosing spondylitis, high-frequency spinal cord stimulation, chronic pain, back pain, case report
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| SYSTEMATIC REVIEW |
Lan Wu, MD, Shouming Chen, MD, Xiaoqin Jiang, PhD, Yan Cheng, BD,
and Wensheng Zhang, PhD
Abstract
Background: Post-dural puncture headache (PDPH), or spinal headache, is the most common serious complication resulting from iatrogenic puncture of the dura during epidural or spinal anesthesia and cerebrospinal fluid (CSF) leak in pregnant women.
Objective: To analyze the effectiveness and safety of opioids as a prophylaxis approach in treating obstetric patients who underwent unintentional dural puncture during the initiation of neuraxial anesthesia.
Study design: A systematic review and meta-analysis.
Setting: No restriction regarding study type.
Methods: PubMed, Embase, and the Cochrane library were searched for available papers published up to September 2020.
Results: According to the eligibility criteria, 10 studies were included with post-dural puncture headache (PDPH) incidence as the primary outcome and the number of epidural blood patch (EBP) required as the second outcome. The risk estimates of each study were reported as odds ratios (ORs). The results showed morphine does not decrease the incidence of PDPH (OR = 0.45, 95% CI: 0.15 - 1.34, P = 0.153, I2 = 74.4%, Pheterogeneity = 0.004) and the use of EBP (OR = 0.40, 95% CI: 0.08 - 1.95, P = 0.259, I2=73.7%, Pheterogeneity = 0.004). Fentanyl does not decrease the incidence of PDPH (OR = 0.35, 95% CI: 0.01-13.77, P = 0.576, I2 = 81.0%, Pheterogeneity = 0.022).
Limitations: The small number of included studies, high heterogeneity, and variety in study designs.
Conclusions: Exposure to opioids for any reason after the diagnosis of unintentional dural puncture is not associated with a reduced risk of PDPH and does not decrease the need for therapeutic EBP.
Key words: headache; heterogeneity; iatrogenic injury; meta-analysis; opioids; patch; post-dural puncture; prophylaxis; Epidural blood.
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| SYSTEMATIC REVIEW |
Vwaire Orhurhu, MD, Lisa Huang, MD, Rodrigo C. Quispe, MD,
Faizan Khan, MD, Jay Karri, MD, Ivan Urits, MD, Jamal Hasoon, MD,
Omar Viswanath, MD, Alan D. Kaye, MD, PhD, and Alaa Abd-Elsayed, MD
Abstract
Background: Headache is a very common condition that affects 5-9% of men and 12-25% of women in North America and Europe. Globally, the prevalence of active headaches among adults is 47%. The most common type of headache is tension headaches (38% of adults), followed by migraines (10%), and chronic headaches (3%). While the majority of headaches are benign, the disorder can severely negatively influence a patients’ quality of life, which is directly reflected in societal costs.
Objective: The objective of this review was to summarize available evidence behind radiofrequency ablation (RFA) for headache, including pain outcome measures, secondary outcomes, and complications.
Study Design: Systematic review.
Setting: This systematic review examined studies that applied the use of RFA for management of headache.
Methods: This systematic review was reported following the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Two reviewers independently scored the methodological quality of the selected studies. Due to heterogeneity of studies, a best-evidence synthesis of the available prognostic factors was provided.
Results: In the present investigation, we evaluated 18 studies composed of 6 randomized controlled trials (RCTs), 6 prospective studies, and 6 retrospective studies. All the studies assessed pain improvement with RFA in patients with headache. Most studies targeted the occipital nerve for treatment. Complications were mostly mild and self-limiting, including eyelid swelling, rash, superficial infection of the procedural site, and worsening of headache.
Limitations: A large variability in definitions of trigeminal neuralgia, radiofrequency technique, and patient selection bias was observed in our selected cohort of studies. In addition, there is a paucity of strong longitudinal RCTs and prospective studies.
Conclusion: Our review discusses several studies that suggest the efficacy of RFA in the treatment of headaches. Outcomes varied based on the difference in approaches regarding continuous radiofrequency versus pulsed radiofrequency, temperature, and duration of administration. The majority of the studies discussed in this review indicate a therapeutic benefit of RFA for headaches over a short-term period. Pain outcomes beyond one year are understudied and further studies are needed to determine the long-term effects of RFA for headaches.
Key words: Headache, radiofrequency ablation
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Since this malpractice insurance program officially launched in November 2018, ASIPP has signed up hundreds of providers with an average savings of 30%. This is professional liability insurance tailored to our specialty and will stand up for us and defend our practices.
Norcal Mutual is 'A' Rated by AM best and is license in all 50 states. To read a few important points to keep in mind about the program, including discounts, administrative defense, cyber coverage, aggressive claims handling, and complimentary award-winning risk management CME activities, click here.
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ASIPP® is now offering our members the benefit of a unique revenue cycle management/ billing service. We have received a tremendous amount of interest in the ASIPP® billing and coding program.
Click here to learn more about the negotiated rate for practices and more!
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ASIPP® has formed a partnership with Henry Schein and PedsPal, a national GPO that has a successful history of negotiating better prices on medical supplies and creating value-added services for the independent physician. Working with MedAssets, PedsPal provides excellent pricing on products like contrast media that alleviate some of the financial pressures you experience today.
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up-to-date news related to you, your practice, and your patients!
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