Increasing deaths from opioid analgesics in the United States: An evaluation in an interventional pain management practice

2018 ◽  
Vol 4 (5) ◽  
pp. 271 ◽  
Author(s):  
Kavita N. Manchikanti, BA ◽  
Laxmaiah Manchikanti, MD ◽  
Kimberly S. Damron, RN ◽  
Vidyasagar Pampati, MSc ◽  
Bert Fellows, MA

Objective: To assess the prevalence of opioid-related deaths in patients in an interventional pain management tertiary referral center.Methods: Patient deaths from March 2003 to February 2007 were evaluated.Results: From March 2003 to February 2007, 2,179 patients were receiving opioids in 2003, 2,445 in 2004, 2,804 in 2005, and 2,965 in 2006, respectively. Overall, 86 percent of the patients were referred by a physician and 90 percent of patients received interventional techniques. There were a total of 91 deaths, of which 60 were categorized as natural deaths, 25 were characterized as accidental deaths, and 6 were characterized as suicidal. Of the 18 drug poisoning deaths, 5 deaths were positively related to prescription drugs, 7 deaths were probably related to prescription drugs, and 6 deaths had no relation to the prescription drugs provided. Total opioidrelated deaths were 12 over this 4-year period with 0.46 in 2003, 2.04 in 2004, 2.85 in 2005, and 1.35 in 2006 per 1,000 population. In contrast, deaths definitely related to prescription opioids were 5 (0.92 per 1,000) over a period of 4 years. In the suicidal group, there were a significantly higher proportion of patients with generalized anxiety disorder.Conclusions: In an interventional pain management practice (a tertiary referral center), the total prevalence of opioid-related deaths varied from 0.46 to 1.78 per 1,000 from 2003 to 2006 with a total of 12 deaths over a period of 4 years. The deaths definitely related to opioid prescriptions were 5 with a rate of 0 to 1.43 per 1,000 over a period of 4 years.

2011 ◽  
Vol 5;14 (5;9) ◽  
pp. 459-467
Author(s):  
Laxmaiah Manchikanti

Background: Interventional pain management is an evolving specialty. Multiple issues including preoperative fasting, sedation, and infection control have not been well investigated and addressed. Based on the necessity for sedation and also the adverse events related to interventional techniques, preoperative fasting is considered practical to avoid postoperative nausea and vomiting. However, there are no guidelines for interventional techniques for sedation or fasting. Most interventional techniques are performed under intravenous or conscious sedation. Objective: To assess the need for preoperative fasting and risks without fasting in patients undergoing interventional techniques. Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Methods: All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including nausea and vomiting. Results: From May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures, with patients receiving sedation during 11,856 encounters. Only 189, or 1.6% of the patients complained of nausea and 3 of them, or 0.02%, experienced vomiting. There were no aspirations. Of the 189 patients with nausea, 80 of them improved significantly prior to discharge without further complaints. Overall, 109 patients, or 0.9% were minimally nauseated prior to discharge. The postoperative complaints of continued nausea were reported in only 26 patients for 6 to 72 hours. There were only 2 events of respiratory depression, which were managed with brief oxygenation with mask without any adverse consequence of nausea, vomiting, aspiration, or other adverse effects. Limitations: Limitations include the nonrandomized observational nature of the study. Conclusion: This study illustrates that postoperative nausea, vomiting, and respiratory depression are extremely rare and aspiration is almost nonexistent, despite almost all of the patients receiving sedation and without preoperative fasting prior to provision of the interventional techniques. Key words: Interventional pain management, interventional techniques, complications, relative risk, evidence-based medicine, preoperative fasting, nausea, vomiting, aspiration


2003 ◽  
Vol 31 (1) ◽  
pp. 75-100 ◽  
Author(s):  
Stephen J. Ziegler ◽  
Nicholas P. Lovrich

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.Although several researchers have examined the regulatory environment and the threat of sanction or harm it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain.


2018 ◽  
Vol 1 (21;1) ◽  
pp. E493-E499 ◽  
Author(s):  
Lisa Doan

Background: Previous surveys have identified variations in practice patterns related to epidural steroid injections. Since then, the United States Food and Drug Administration (FDA) has required the addition of drug warning labels for injectable corticosteroids. Updated evidence, as well as scrutiny from regulatory agencies, may affect practice patterns. Objective: To provide an update on interlaminar epidural steroid injection (ILESI) practice patterns, we surveyed interventional pain management (IPM) physicians in the United States. Study Design and Setting: This was a cross-sectional survey of IPM physicians in the United States. Methods: A web-based survey was distributed to IPM physicians in the United States selected from the Accreditation Council for Graduate Medical Education accredited pain medicine fellowship program list as well as the American Society of Interventional Pain Physicians membership database. Physicians were queried about ILESI practices, including needle size, use of image guidance, level of injection, identification of the epidural space, and preference for injectate. Results: A total of 249 responses were analyzed. All respondents used image guidance for ILESI. There were variations in needle size, use of contrast, number of fluoroscopic views utilized, technique for identifying the epidural space, and choice of injectate. Limitations: The response rate is a limitation, thus the results may not be representative of all United States IPM physicians. Conclusions: Though all respondents used image guidance for ILESI, variations in other ILESI practices still exist. Since the closure of this survey, a multi-society pain workgroup published recommendations regarding ESI practices. Our survey findings support the need for more evidencebased guidelines regarding ESI. Key words: Epidural injection, epidural steroids, survey, low back pain, neck pain, technique


2007 ◽  
Vol 6;10 (6;11) ◽  
pp. 725-741
Author(s):  
Laxmaiah Manchikanti

The United States spends more of its wealth on healthcare than any other developed country, and that share is rising. Supporters of the free market system point to the regulatory burden on the healthcare industry. Estimates of the regulatory costs of US healthcare range from $58 billion to $339 billion. A recent report indicates that approximately $8 billion of the US healthcare budget of $1.9 trillion is spent on physicians’ extra income derived from their ownership in outpatient facilities, such as ambulatory surgery centers, diagnostic imaging centers, and diagnostic testing and procedure laboratories. It is essential for an interventionalist to understand fraud and abuse, self-referrals, and the implications of the Stark law and anti-kickback statutes, among a maze of other regulations. It is important for interventionalists to understand and also be able to invest in protected and approved investments and also be involved in business dealings which are within the law. Various reasons include: decreasing reimbursements by Medicare, Medicaid, managed care, and all other third-party payors; increased competition in providing interventional pain management; increasing costs of overhead and doing business; the popularity of interventional pain management, leading each and every pain physician to want to provide the service; concerns in multiple settings, including offices, ambulatory surgery centers (ASCs), hospitals, private practices, and academic settings; and finally, the failure to develop strategies to remove oneself from questionable investments and business associations. Self-referrals occur when physicians refer to medical facilities in which they have financial interest. Multiple concerns related to self-referral, including conflict of interest and increased costs to the Medicare program, resulted in a ban on self-referral arrangements for clinical laboratory services under the Medicare program in 1989 known as Stark I. In 1993, the Stark I prohibition on self-referrals by physicians expanded to include 10 additional healthcare services known as designated health services or DHS. The 1993 expansion of Stark I was enacted in 1995 as Stark II. In 2007, CMS adopted Phase III of the regulations interpreting Stark II. Phase III made multiple changes and clarified many previous issues, and it becomes effective December 4, 2007. While it is mandatory to obtain expert legal advice and this manuscript in no way provides the extensive navigation required through the maze of Stark laws and other anti-kickback statutes, it is incumbent on interventionalists in all settings of practice to have appropriate knowledge of the Stark laws and exceptions and of the anti-kickback statute and safe harbors. Penalties for violating the Stark laws are severe, including fines of up to $15,000 per service and the economic threat of exclusion from participation in federal healthcare programs, which may result in exclusion of any type of healthcare program and loss of privileges at hospitals and surgery centers. This manuscript reviews physician practices in general, physician payments, and self-referral patterns in particular, the evolution of the Stark law and regulations and its implications for physician practices. This article is not, and should not be, construed as legal advice or an opinion on specific situations. Key words: Self-referral, Stark I, Stark II, Phase I, Phase II, Phase III, regulations and laws, imaging services, ambulatory surgery centers, incident-to services, in-office ancillary services, antikickback statute


2011 ◽  
Vol 3;14 (2;3) ◽  
pp. E177-E212 ◽  
Author(s):  
Laxmaiah Manchikanti

With health care expenditures skyrocketing, coupled with pervasive quality deficits, pressures to provide better and more proficient care continue to shape the landscape of the U.S. health care system. Payers, both federal and private, have laid out several initiatives designed to curtail costs, including value-based reimbursement programs, cost-shifting expenses to the consumer, reducing reimbursements for physicians, steering health care to more efficient settings, and finally affordable health care reform. Consequently, one of the major aspects in the expansion of health care for improving quality and reducing costs is surgical services. Nearly 57 million outpatient procedures are performed annually in the United States, 14 million of which occur in elderly patients. Increasing use of these minor, yet common, procedures contributes to rising health care expenditures. Once exclusive within hospitals, more and more outpatient procedures are being performed in freestanding ambulatory surgery centers (ASCs), physician offices, visits to which have increased over 300% during the past decade. Concurrent with this growing demand, the number of ASCs has more than doubled since the 1990s, with more than 5,000 facilities currently in operation nationwide. Further, total surgical center ASC payments have increased from $1.2 billion in 1999 to $3.2 billion in 2009, a 167% increase. On the same lines, growth and expenditures for hospital outpatient department (HOPD) services and office procedures also have been evident at similar levels. Recent surveys have illustrated on overall annual growth per capita in Medicare allowed ASC services of pain management of 23%, with 27% growth seen in ASCs and 16% of the growth seen in HOPD. Further, the proportion of interventional pain management which was 4% of Medicare ASC spending in 2000 has increased to 10% in 2007. Thus, interventional pain management as an evolving specialty is one of the most commonly performed procedures in ASC settings apart from HOPDs and well-equipped offices. In June 1998, the Health Care Financing Administration (HCFA) proposed an ASC rule in which at least 60% of interventional procedures were eliminated from ASCs, and the remaining 40% faced substantial cuts in payments. Following the publication of this rule, based on public comments and demand, Congress intervened and delayed implementation of the rule for several years. The Centers for Medicare and Medicaid Services (CMS) published its proposed outpatient prospective system for ASCs in 2006, setting ASC payments at 62% of HOPD payments. Following multiple changes, the rule was incorporated with a 4-year transition formula which ended in 2010, with full effect occurring in 2011 with ASCs reimbursed at 57% of HOPD payments. Thus, the landscape of interventional pain management in ambulatory surgery centers has been constantly changing with declining reimbursements, issues of fraud and abuse, and ever-increasing regulations. Key words: Outpatient prospective payment system, ambulatory surgery center payment system, Government Accountability Office, Medicare Modernization and Improvement Act, interventional techniques


2013 ◽  
Vol 6;16 (6;11) ◽  
pp. E635-E670
Author(s):  
Laxmaiah Manchikanti

The prevalence, costs, and disability associated with chronic pain continue to escalate. So too, the numerous modalities of treatments applied in managing these patients continue to increase as well. In the period from 2000 to 2011 interventional techniques increased 228%. In addition, analysis of utilization trends and expenditures for spinal interventional techniques alone from 2000 to 2008 illustrated an increase in Medicare fee-for-service expenditures of 240% in terms of dollars spent in the United States. The Office of Inspector General (OIG) of the Department of Health and Human Services showed an increase in facet joint and transforaminal epidural injections, with a significant proportion of these services did not meet the medical necessity criteria. The increasing utilization of interventional techniques is also associated with significant variations among specialty groups and regional variations among states. Overall procedures have increased by 173%, with rate of 130% per 100,000 Medicare beneficiaries for epidural injections; 383%, with a rate of 308% for facet joint interventions; and overall 410%, or a rate of 331% for sacroiliac joint interventions. Certain high volume interventions such as lumbar transforaminal epidural injections and lumbar facet joint neurolysis have actually increased a staggering 806% and 662%. Coverage policies across ambulatory settings and by multiple payers are highly variable. Apart from variability in the development of coverage policies, payments also substantially vary by site of service. In general, amongst the various ambulatory settings the highest payments are made to hospital outpatient departments (HOPDs) the lowest to in-office procedures, and payment to ambulatory surgery centers (ASCs) falling somewhere in the middle. This manuscript describes the many differences that exist between the various settings, and includes suggestions for accountable interventional pain management with coverage for techniques with evidence, addressing excessive use of specific techniques, and equalizing payments across multiple ambulatory settings. Key words: Accountable interventional pain management, Medicare, Medicare Evidence Development & Coverage Advisory Committee, epidural injections, facet joint interventions, sacroiliac joint injections, payment policies


2015 ◽  
Vol 5;18 (5;9) ◽  
pp. E685-E712
Author(s):  
Laxmaiah Manchikanti

The unfunded mandate for the implementation of International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) is scheduled October 1, 2015. The development of ICD-10-CM has been a complicated process. We have endeavored to keep Interventional Pain Management doctors apprised via a variety of related topical manuscripts. The major issues relate to the lack of formal physician participation in its preparation. While the American Health Information Management Association (AHIMA) and American Hospital Association (AHA) as active partners in its preparation. Centers for Medicare and Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) are major players; 3M and Blue Cross Blue Shield Association are also involved. The cost of ICD-10-CM implementation is high, similar to the implementation of electronic health records (EHRs), likely consuming substantial resources. While ICD-10, utilized worldwide, includes 14,400 different codes, ICD-10-CM, specific for the United States, has expanded to 144,000 codes, which also includes procedural coding system. It is imperative for physicians to prepare for the mandatory implementation. Conversion from ICD-9-CM to ICD-10-CM coding in interventional pain management is not a conversion of one to one that can be easily obtained from software packages. It is a both a difficult and time-consuming task with each physician, early on, expected to spend on estimation at least 10 minutes per visit on extra coding for established and new patients. For interventional pain physicians, there have been a multitude of changes, including creation of new codes and confusing conversion of existing codes. This manuscript describes a variety of codes that are relevant to interventional pain physicians and often utilized in daily practices. It is our objective that this manuscript will provide coding assistance to interventional pain physicians. Key words: ICD-9-CM (International Classification of Diseases, Ninth revision, Clinical Modification), ICD-10, ICD-10-CM (International Classification of Diseases, 10th Revision), Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology (HIT)


2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E27-E52
Author(s):  
Laxmaiah Manchikanti

Physician spending is complex related to national health care spending, government regulations, health care reform, private insurers, physician practice, and patient utilization patterns. In determining payment rates for each service on the fee schedule, the Centers for Medicare and Medicaid Services (CMS) considers the amount of work required to provide a service, expenses related to maintaining a practice, and liability insurance costs. The value of 3 types of resources are adjusted on a yearly basis of the combined total multiplied by a standard dollar amount, called the fee schedules conversion factor, which was $33.98 in 2011, to arrive at the payment amount. This factor will stay almost the same ($34.03) unless a 27.4% cut in the sustainable growth rate (SGR) takes place or CMS enacts further reductions. With a 27.4% cut, the conversion factor will be $24.67 in 2012 after the first 2 months if Congress fails to act. Since the inception of Medicare programs in 1965, several methods have been used to determine the amounts paid to physicians for each covered service. The SGR was enacted in 1997 to determine physician payment updates under Medicare Part B with intent to reduce Medicare physician payment updates to offset the growth and utilization of physician services that exceed gross domestic product (GDP) growth. This is achieved by setting an overall target amount of spending for physicians’ services and adjusting payment rates annually to reflect differences between actual spending and the spending target. Since 2002, the SGR has annually recommended reductions in Medicare reimbursements. Payments were cut in 2002 by 4.8%. Since then, Congress has intervened on 13 separate occasions to prevent additional cuts from being imposed. The Medicare physician payment rule of 2012, which is still undergoing revisions -- but considered as the final rule-- is a 1,235 page document, released in November 2011. In this manuscript, we will describe important aspects of the 2012 physician fee schedule which include potentially disvalued services under the physician fee schedule, expansion of the multiple procedure payment reduction (MPPR) policy, establishment of the valuebased payment modifier, changes to direct practice expenses (PEs), electronic prescribing, the Physician Quality Reporting System (PQRS), and lab testing signatures, along with their implications. Additionally, the impact of multiple changes on interventional pain management will be described. In conclusion, interventional pain management is facing widespread challenges in the U.S. health care system. A historic reform, which has been passed by Congress and signed into law, whose survivability is not quite known yet, is affecting medicine drastically in the United States. Interventional pain management, like other evolving specialties, will probably most likely suffer under the new affordable health care law and regulatory burden. Key words: Health policy, physician payment policy, physician fee schedule, Medicare, sustained growth rate formula, interventional pain management, regulatory reform


2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 161-186
Author(s):  
Laxmaiah Manchikanti

Evidence-based medicine, systematic reviews, and guidelines are part of modern interventional pain management. As in other specialties in the United States, evidence-based medicine appears to motivate the search for answers to numerous questions related to costs and quality of health care as well as access to care. Scientific, relevant evidence is essential in clinical care, policy-making, dispute resolution, and law. Consequently, evidence based practice brings together pertinent, trustworthy information by systematically acquiring, analyzing, and transferring research findings into clinical, management, and policy arenas. In the United States, researchers, clinicians, professional organizations, and government are looking for a sensible approach to health care with practical evidence-based medicine. All modes of evidence-based practice, either in the form of evidence-based medicine, systematic reviews, meta-analysis, or guidelines, evolve through a methodological, rational accumulation, analysis, and understanding of the evidentiary knowledge that can be applied in clinical settings. Historically, evidence-based medicine is traceable to the 1700s, even though it was not explicitly defined and advanced until the late 1970s and early 1980s. Evidence-based medicine was initially called “critical appraisal” to describe the application of basic rules of evidence as they evolve into application in daily practices. Evidence-based medicine is defined as a conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based practice is defined based on 4 basic and important contingencies, which include recognition of the patient’s problem and construction of a structured clinical question, thorough search of medical literature to retrieve the best available evidence to answer the question, critical appraisal of all available evidence, and integration of the evidence with all aspects and contexts of the clinical circumstances. Systematic reviews provide the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. While systematic reviews are close to meta-analysis, they are vastly different from narrative reviews and health technology assessments. Clinical practice guidelines are systematically developed statements that aim to help physicians and patients reach the best health care decisions. Appropriately developed guidelines incorporate validity, reliability, reproducibility, clinical applicability and flexibility, clarity, development through a multidisciplinary process, scheduled reviews, and documentation. Thus, evidence-based clinical practice guidelines represent statements developed to improve the quality of care, patient access, treatment outcomes, appropriateness of care, efficiency and effectiveness and achieve cost containment by improving the cost benefit ratio. Part 1 of this series in evidence-based medicine, systematic reviews, and guidelines in interventional pain management provides an introduction and general considerations of these 3 aspects in interventional pain management. Key words: Evidence-based medicine, systematic reviews, clinical guidelines, narrative reviews, health technology assessments, grading of evidence, recommendations, grading systems, strength of evidence.


2019 ◽  
Vol 13 (3) ◽  
pp. 242-248
Author(s):  
Robert G. Smith

The foot and ankle physician is no stranger to the difficulties in achieving optimal pain therapy. There remains much confusion and conflicting information available to nonspecialist prescribers regarding opioid therapy as well as great deal of fear or opiophobia during the prescribing and monitoring of opioids worldwide. The role of the lower extremity specialist provider is to responsibly provide pain management to their patients in an error-free environment. The purpose of this article is to explore the central theme of responsible opioid pain management worldwide. This review focuses on the prescribing strategies of opioid analgesics to treat lower-extremity pain. Pharmacology of opioid agents and opioid prescribing strategies will be presented. Then, the concept of multimodal pain relief criteria for selecting appropriate opioid analgesics and use of adjunctive therapies to prevent opioid misuse as presented in the current medical literature is reported. Finally, a commentary and discussion centered on the actions of pharmaceutical companies of promoting their opioid products and the negative outcomes of their actions in the United States that may go worldwide if behaviors of these companies are not recognized by the foot and ankle specialist.


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