COVID-19 Pandemic Reduced Utilization Of Interventional Techniques 18.7% In Managing Chronic Pain In The Medicare Population In 2020: Analysis Of Utilization Data From 2000 To 2020.

BACKGROUND: Multiple publications have shown the significant impact of the COVID-19 pandemic on US healthcare and increasing costs over the recent years in managing low back and neck pain as well as other musculoskeletal disorders. The COVID-19 pandemic has affected many modalities of treatments, including those related to chronic pain management, including both interventional techniques and opioids. While there have not been assessments of utilization of interventional techniques specific to the ongoing COVID-19 pandemic, previous analysis published with data from 2000 to 2018 demonstrated a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 fee-for-service (FFS) in the Medicare population. During that same time, the Medicare population has grown by 3% annually. OBJECTIVES: The objectives of this analysis include an evaluation of the impact of the COVID-19 pandemic, as well as an updated assessment of the utilization of interventional techniques in managing chronic pain in the Medicare population from 2010 to 2019, 2010 to 2020, and 2019 to 2020 in the FFS Medicare population of the United States. STUDY DESIGN: Utilization patterns and variables of interventional techniques with the impact of the COVID-19 pandemic in managing chronic pain were assessed from 2000 to 2020 in the FFS Medicare population of the United States. METHODS: The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2020. RESULTS: The results of the present investigation revealed an 18.7% decrease in utilization of all interventional techniques per 100,000 Medicare beneficiaries from 2019 to 2020, with a 19% decrease for epidural and adhesiolysis procedures, a 17.5% decrease for facet joint interventions and sacroiliac joint blocks, and a 25.4% decrease for disc procedures and other types of nerve blocks. The results differed from 2000 to 2010 with an annualized increase of 10.2% per 100,000 Medicare population compared to an annualized decrease of 0.4% from 2010 to 2019, and a 2.5% decrease from 2010 to 2020 for all interventional techniques. For epidural and adhesiolysis procedures decreases were more significant and annualized at 3.1% from 2010 to 2019, increasing the decline to 4.8% from 2010 to 2020. For facet joint interventions and sacroiliac joint blocks, the reversal of growth patterns was observed but maintained at an annualized rate increase of 2.1% from 2010 to 2019, which changed to a decrease of 0.01% from 2010 to 2020. Disc procedures and other types of nerve blocks showed similar patterns as epidurals with an 0.8% annualized reduction from 2010 to 2019, which was further reduced to 3.6% from 2010 to 2020 due to COVID-19. LIMITATIONS: Data for the COVID-19 pandemic impact were available only for 2019 and 2020 and only the FFS Medicare population was utilized; utilization patterns in Medicare Advantage Plans, which constitutes almost 40% of the Medicare enrollment in 2020 were not available. Moreover, this analysis shares the limitations present in all retrospective reviews of claims based datasets. CONCLUSION: The decline driven by the COVID-19 pandemic was 18.7% from 2019 to 2020. Overall decline in utilization in interventional techniques from 2010 to 2020 was 22.0% per 100,000 Medicare population, with an annual diminution of 2.5%, despite an increase in the population rate of 3.3% annualized (38.9% overall) and Medicare enrollees of 33.4% and 2.9% annually.

Update on Reversal and Decline of Growth of Utilization of Interventional Techniques In Managing Chronic Pain in the Medicare Population from 2000 to 2018.

BACKGROUND: The cost of US health care continues to increase, with treatments related to low back and neck pain and other musculoskeletal disorders accounting for the third highest amount of various disease categories. Interventional techniques for managing pain apart from conservative modalities and surgical interventions, have generally been thought to be growing rapidly. However, a recent analysis of utilization of interventional techniques from 2000 to 2016 has shown a modest decline from 2009 to 2016, compared to 2000 to 2009. OBJECTIVES: The objectives of this analysis include providing an update on utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 in the fee-for-service (FFS) Medicare population of the United States. STUDY DESIGN: Utilization patterns and variables of interventional techniques in managing chronic pain were assessed from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population of the United States. METHODS: The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. The analysis of data showed that there was a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 FFS Medicare population, despite an increase of 0.7% per year of population growth (3.2% of those 65 years or older) and a 3% annual increase in Medicare participation from 2009 to 2018. Medicare data from 2000 to 2009 showed an increase of 11.8% per year per 100,000 individuals of the Medicare population. The 2009 to 2018 data also showed a 2.6% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 population of FFS Medicare, and a 1% decrease for disc procedures and other types of nerve blocks, while there was an increase of 0.9% annually for facet joint interventions and sacroiliac joint blocks. LIMITATIONS: Limitations of this analysis include: only the Medicare population was utilized, and among the Medicare population, only the FFS population was evaluated; utilization patterns in Medicare Advantage Plans, which constitutes almost 30% of the population were not considered. Further, the utilization data for individual states was sparse and may not be accurate. CONCLUSION: The decline in utilization of interventional techniques continued from 2009 to 2018 with 6.7% per 100,000 Medicare population, with an annual decline of 0.8%, despite an increase in the population rate and Medicare enrollees of 0.7% and 3% annually. KEY WORDS: Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks.

Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use. OBJECTIVES: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique. METHODS: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Utilization of Facet Joint and Sacroiliac Joint Interventions in Medicare Population from 2000 to 2014: Explosive Growth Continues!

Increasing utilization of interventional techniques in managing chronic spinal pain, specifically facet joint interventions and sacroiliac joint injections, is a major concern of healthcare policy makers. We analyzed the patterns of utilization of facet and sacroiliac joint interventions in managing chronic spinal pain. The results showed significant increase of facet joint interventions and sacroiliac joint injections from 2000 to 2014 in Medicare FFS service beneficiaries. Overall, the Medicare population increased 35 %, whereas facet joint and sacroiliac joint interventions increased 313.3 % per 100,000 Medicare population with an annual increase of 10.7 %. While the increases were uniform from 2000 to 2014, there were some decreases noted for facet joint interventions in 2007, 2010, and 2013, whereas for sacroiliac joint injections, the decreases were noted in 2007 and 2013. The increases were for cervical and thoracic facet neurolysis at 911.5 % compared to lumbosacral facet neurolysis of 567.8 %, 362.9 % of cervical and thoracic facet joint blocks, 316.9 % of sacroiliac joints injections, and finally 227.3 % of lumbosacral facet joint blocks.

Epidural Injections for Lumbar Radiculopathy and Spinal Stenosis: A Comparative Systematic Review and Meta-Analysis.

BACKGROUND: The prevalence of chronic low back pain and related disability is rapidly increasing as are the myriad treatments, including epidural injections. Even though epidural injections are one of the most commonly performed procedures in managing low back and lower extremity pain, starting in 1901 with local anesthetic alone, conflicting recommendations have been provided, despite the extensive literature. Recently Chou et al performed a technology assessment review for Agency for Healthcare Research and Quality (AHRQ) part of which was published in Annals of Internal Medicine showing lack of effectiveness of epidural steroid injections in managing lumbar radiculopathy and spinal stenosis. In contrast, multiple other publications have supported the efficacy and use of epidural injections. PURPOSE: To assess the efficacy of 3 categories of epidural injections for lumbar and spinal stenosis: performed with saline with steroids, local anesthetic alone, or steroids with local anesthetic and separate facts from opinions. DATA SOURCES: PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed through August 2015. STUDY SELECTION: Randomized trials, either placebo or active control, of epidural injections for lumbar radiculopathy and spinal stenosis. DATA EXTRACTION: Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing principles of best evidence synthesis. DATA SYNTHESIS: Thirty-nine randomized controlled trials met inclusion criteria. There were 9 placebo-controlled trials evaluating epidural corticosteroid injections, either with sodium chloride solution or bupivacaine, compared to placebo injections. There were 12 studies comparing local anesthetic alone to local anesthetic with steroid. RESULTS: A meta-analysis of 5 studies utilizing sodium chloride or bupivacaine with steroid showed a lack of efficacy.A comparison of lidocaine to lidocaine with steroids in 7 studies showed significant effectiveness from baseline to long-term follow-up periods. Meta-analysis showed a similar effectiveness for pain and function without non-inferiority of lidocaine compared to lidocaine with steroid at 3 months and 12 months. LIMITATIONS: The review was restricted to the data available with at least 3 months of follow-up, which excluded some studies. The inclusion criteria were restricted to English language studies. CONCLUSION: Epidural corticosteroid injections for radiculopathy or spinal stenosis with sodium chloride solution or bupivacaine were shown to be ineffective. Lidocaine alone or lidocaine in conjunction with steroids were significantly effective.

The Tragedy of the Implementation of ICD-10-CM as ICD-10: Is the Cart Before the Horse or Is There a Tragic Paradox of Misinformation and Ignorance?

The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health Information Management Association (AHIMA). The AHIMA has taken the lead with the AHA just behind, both with escalating profits and influence, essentially creating a statutory monopoly for their own benefit. Further, the ICD-10-CM coalition includes 3M which will boost its revenues and profits substantially with its implementation and Blue Cross Blue Shield which has its own agenda. Physician groups are not a party to these cooperating parties or coalitions, having only a peripheral involvement. ICD-10-CM creates numerous deficiencies with 500 codes that are more specific in ICD-9-CM than ICD-10-CM. The costs of an implementation are enormous, along with maintenance costs, productivity, and cash disruptions.

Analysis of the carrot and stick policy of repeal of the sustainable growth rate formula: the good, the bad, and the ugly.

The Balanced Budget Act which became law in 1997 was designed to help stem the increasing in costs of healthcare. The Sustainable Growth Rate (SGR) formula was incorporated into that law as a method of helping balance the budget through a complex formula tying reimbursement to the growth in the economy. Soon after its inception, the flawed nature of the formula, linking the balancing of the federal budget to physician professional fees was realized. Congress has provided multiple short-term fixes known as SGR patches over the years so as to avoid generally progressively larger negative corrections to professional reimbursement. The near annual SGR correction requirement has been compared to Groundhog Day in the legislative arena. Over the years, physician and other providers faced numerous looming, large cuts. Most recently, on April 1, 2015 physicians faced a 21.2% cut in provider payments. To the surprise of many, in April 2015 a bipartisan bicameral effort permanently repealed the Medicare SGR formula for controlling provider payment. The repeal of SGR means the temporary measures to override the growth rate formula will no longer dominate Medicare policy discussions and now the focus turns to continue payment reforms. The MACRA provides physicians and other health care professionals with stable fee update for 5 years and it follows with a new incentive program, termed the Merit-based Incentive Payment System (MIPS) replacing and consolidating pre-existing incentive payment programs: meaningful use of electronic health records (EHR), physician quality reporting system, and the value-based payment modified. Thus, payments to clinicians will be subjected to adjustments based on participation in MIPS or other approved alternative payment mechanisms. This legislation also creates numerous other regulations. The MACRA has been criticized for providing insufficient statutory updates, enacting a flawed quality and performance improvement program associated with MIPS and inappropriate use of utilization and payment data. Thus, the MACRA offers physicians a predictable schedule for Medicare rates - a carrot, and controls the physician behaviors with payment reforms analogous to a stick. Thus, it could be said that this legislation embodies some good, bad, and ugly aspects.

Zohydro approval by food and drug administration: controversial or frightening?

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain - the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future.

Epidural steroid warning controversy still dogging FDA.

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence.

Assessment of methodologic quality of randomized trials of interventional techniques: development of an interventional pain management specific instrument.

BACKGROUND: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. OBJECTIVES: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques. METHODS: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques. RESULTS: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques.

Development of an interventional pain management specific instrument for methodologic quality assessment of nonrandomized studies of interventional techniques.

BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.

Lessons learned in the abuse of pain-relief medication: a focus on healthcare costs.

The increasing prevalence of chronic pain with its major societal impact and the escalating use of opioids in managing it, along with their misuse, abuse, associated fatalities and costs, are epidemics in modern medicine. Over the past two decades, multiple lessons have been learned addressing various issues of abuse. Multiple measures have already been incorporated and more are expected to be incorporated in the future, which in turn may curtail the abuse of drugs and reduce healthcare costs, but these measures may also jeopardize access to appropriate pain treatment. This manuscript describes the lessons learned from the misuse, abuse and diversion of opioids, escalating healthcare costs and the means to control this epidemic.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment. OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids. RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping. DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Pain assessment: subjectivity, objectivity, and the use of neurotechnology.

The pain clinician is confronted with the formidable task of objectifying the subjective phenomenon of pain so as to determine the right treatments for both the pain syndrome and the patient in whom the pathology is expressed. However, the experience of pain - and its expression - remains enigmatic. Can currently available evaluative tools, questionnaires, and scales actually provide adequately objective information about the experiential dimensions of pain? Can, or will, current and future iterations of biotechnology - whether used singularly or in combination (with other technologies as well as observational-behavioral methods) - afford objective validation of pain? And what of the clinical, ethical, legal and social issues that arise in and from the use - and potential misuse - of these approaches? Subsequent trajectories of clinical care depend upon the findings gained through the use of these techniques and their inappropriate employment - or misinterpretation of the results they provide - can lead to misdiagnoses and incorrect treatment. This essay is the first of a two-part series that explicates how the intellectual tasks of knowing about pain and the assessment of its experience and expression in the pain patient are constituent to the moral responsibility of pain medicine. Herein, we discuss the problem of pain and its expression, and those methods, techniques, and technologies available to bridge the gap between subjective experience and objective evaluation. We address how these assessment approaches are fundamental to apprehend both pain as an objective, neurological event, and its impact upon the subjective experience, existence, and expectations of the person in pain. In this way, we argue that the right use of technology - together with inter-subjectivity, compassion, and insight - can sustain the good of pain care as both a therapeutic and moral enterprise.

Analysis of the growth of epidural injections and costs in the Medicare population: a comparative evaluation of 1997, 2002, and 2006 data.

BACKGROUND: Interventional techniques for the treatment of spinal techniques are commonly used and are increasing exponentially. Epidural injections and facet joint interventions are the 2 most commonly utilized procedures in interventional pain management. The current literature regarding the effectiveness of epidural injections is sparse with highly variable outcomes based on the technique, outcome measures, patient selection, and methodology. Multiple reports have illustrated the exponential growth of lumbosacral injections with significant geographic variations in the administration of epidural injections in Medicare patients. However, an analysis of the growth of epidural injections and costs in the Medicare population has not been performed with recent data and has not been looked at from an interventional pain management perspective. STUDY DESIGN: Analysis of epidural injection growth and costs in Medicare's population 1997, 2002, and 2006. OBJECTIVES: The primary purpose of this study was to evaluate the use of all types of epidural injections (i.e. caudal, interlaminar, and transforaminal in lumbar, cervical and thoracic regions), and other epidural procedures, including epidural adhesiolysis. In addition, the purpose was to identify trends in the number of procedures, reimbursement, specialty involvement, fluoroscopy use, and indications from 1997 to 2006. METHODS: The Centers for Medicare and Medicaid Services (CMS) 5% national sample carrier claim record data from 1997, 2002, and 2006 was utilized. OUTCOMES ASSESSMENT: Outcome measures included Medicare beneficiaries' characteristics receiving epidural injections, epidural injections by place of service, type of specialty, reimbursement characteristics, and other variables. RESULTS: Epidural injections increased significantly in Medicare beneficiaries from 1997 to 2006. Patients receiving epidurals increased by 106.3%; visits per 100,000 population increased 102.7%. Hospital outpatient department (HOPD) payments increased significantly; ASC average payments decreased; overall payments increased. The increase in procedures performed by general physicians outpaced that of interventional pain management (IPM) physicians. LIMITATIONS: Study limitations include no Medicare Advantage patients; potential documentation, coding, and billing errors. CONCLUSIONS: Epidural injections grew significantly. This growth appears to coincide with chronic low back pain growth and other treatments for low back pain. Since many procedures are performed without fluoroscopy, continued growth and inappropriate provision of services might reduce access.

Explosive growth of facet joint interventions in the Medicare population in the United States: a comparative evaluation of 1997, 2002, and 2006 data.

BACKGROUND: The Office of Inspector General of the Department of Health and Human Services (OIG-DHHS) issued a report which showed explosive growth and also raised questions of lack of medical necessity and/or indications for facet joint injection services in 2006.The purpose of the study was to determine trends of frequency and cost of facet joint interventions in managing spinal pain. METHODS: This analysis was performed to determine trends of frequency and cost of facet jointInterventions in managing spinal pain, utilizing the annual 5% national sample of the Centers forMedicare and Medicaid Services (CMS) for 1997, 2002, and 2006.Outcome measures included overall characteristics of Medicare beneficiaries receiving facet joint interventions, utilization of facet joint interventions by place of service, by specialty, reimbursement characteristics, and other variables. RESULTS: From 1997 to 2006, the number of patients receiving facet joint interventions per 100,000Medicare population increased 386%, facet joint visits increased 446%, and facet joint interventions increased 543%. The increases were higher in patients aged less than 65 years compared to those 65 or older with patients increasing 504% vs. 355%, visits increasing 587% vs. 404%, and services increasing 683% vs. 498%.Total expenditures for facet joint interventions in the Medicare population increased from over $229 million in 2002 to over $511 million in 2006, with an overall increase of 123%. In 2006, there was a 26.8-fold difference in utilization of facet joint intervention services in Florida compared to the state with the lowest utilization - Hawaii.There was an annual increase of 277.3% in the utilization of facet joint interventions by general physicians, whereas a 99.5% annual increase was seen for nurse practitioners (NPs) and certified registered nurse anesthetists (CRNAs) from 2002 to 2006. Further, in Florida, 47% of facet joint interventions were performed by general physicians. CONCLUSIONS: The reported explosive growth of facet joint interventions in managing spinal pain in certain regions and by certain specialties may result in increased regulations and scrutiny with reduced access.

Interventional pain management at crossroads: the perfect storm brewing for a new decade of challenges.

The health care industry in general and care of chronic pain in particular are described as recession-proof. However, a perfect storm with a confluence of many factors and events -none of which alone is particularly devastating - is brewing and may create a catastrophic force, even in a small specialty such as interventional pain management. Multiple challenges related to interventional pain management in the current decade will include individual and group physicians, office practices, ambulatory surgery centers (ASCs), and hospital outpatient departments (HOPD). Rising health care costs are discussed on a daily basis in the United States. The critics have claimed that health outcomes are the same as or worse than those in other countries, but others have presented the evidence that the United States has the best health care system. All agree it is essential to reduce costs. Numerous factors contribute to increasing health care costs. They include administrative costs, waste, abuse, and fraud. It has been claimed the U.S. health care system wastes up to $800 billion a year. Of this, fraud accounts for approximately $200 billion a year, involving fraudulent Medicare claims, kickbacks for referrals for unnecessary services, and other scams. Administrative inefficiency and redundant paperwork accounts for 18% of health care waste, whereas medical mistakes account for $50 billion to $100 billion in unnecessary spending each year, or 11% of the total. Further, American physicians spend nearly 8 hours per week on paperwork and employ 1.66 clerical workers per doctor, more than any other country. It has been illustrated that it takes $60,000 to $88,000 per physician per year, equal to one-third of a family practitioner's gross income, and $23 to $31 billion each year in total to interact with health insurance plans. The studies have illustrated that an average physician spends $68,274 per year communicating with insurance companies and performing other non-medical functions. For an office-based practice, the overall total in the United States is $38.7 billion, or $85,276 per physician. In the United States there are 2 types of physician payment systems: private health care and Medicare. Medicare has moved away from the Medicare Economic Index (MEI) and introduced the sustainable growth rate (SGR) formula which has led to cuts in physician payments on a yearly basis. In 2010 and beyond into the new decade, interventional pain management will see significant changes in how we practice medicine. There is focus on avoiding waste, abuse, fraud, and also cutting costs. Evidence-based medicine (EBM) and comparative effectiveness research (CER) have been introduced as cost-cutting and rationing measures, however, with biased approaches. This manuscript will analyze various issues related to interventional pain management with a critical analysis of physician payments, office facility payments, and ASC payments by various payor groups.

Facts, fallacies, and politics of comparative effectiveness research: Part I. Basic considerations.

While the United States leads the world in many measures of health care innovation, it has been suggested that it lags behind many developed nations in a variety of health outcomes. It has also been stated that the United States continues to outspend all other Organisation for Economic Co-operation and Development (OECD) countries by a wide margin. Spending on health goods and services per person in the United States, in 2007, increased to $7,290 - almost 2(1/2) times the average of all OECD countries. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. The increases are illustrated in both public and private sectors. Higher health care costs in the United States are implied from the variations in the medical care from area to area around the country, with almost 50% of medical care being not evidence-based, and finally as much as 30% of spending reflecting medical care of uncertain or questionable value. Thus, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States and provide high quality, less expensive, universal health care. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The efforts of CER in the United States date back to the late 1970's even though it was officially born with the Medicare Modernization Act (MMA) and has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis for health care decision-making in many other countries. According to the International Network of Agencies for Health Technology Assessments (INAHTA), many industrialized countries have bodies that are charged with health technology assessments (HTAs) or comparative effectiveness studies. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is making a rapid surge in the United States, supporters and opponents are expressing their views. Part I of this comprehensive review will describe facts, fallacies, and politics of CER with discussions to understand basic concepts of CER.

Facts, fallacies, and politics of comparative effectiveness research: Part 2 - implications for interventional pain management.

The United States leads the world in many measures of health care innovation. However, it has been criticized to lag behind many developed nations in important health outcomes including mortality rates and higher health care costs. The surveys have shown the United States to outspend all other Organisation for Economic Co-operation and Development (OECD) countries with spending on health goods and services per person of $7,290 - almost 2(1/2) times the average of all OECD countries in 2007. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States providing high quality, less expensive, universal health care. The efforts of CER in the United States date back to the late 1970s and it was officially inaugurated with the enactment of the Medicare Modernization Act (MMA). It has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis of decision for health care in many other countries. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is taking a rapid surge in the United States, supporters and opponents are emerging expressing their views. Since interventional pain management is a new and evolving specialty, with ownership claimed by numerous organizations, at times it is felt as if it has many fathers and other times it becomes an orphan. Part 2 of this comprehensive review will provide facts, fallacies, and politics of CER along with discussion of potential outcomes, impact of CER on health care delivery, and implications for interventional pain management in the United States.