These are several audio presentations about Narxcare
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https://www.medpagetoday.com/surgery/orthopedics/117856
The Lown Institute called out dozens of hospitals for performing unnecessary surgeries on Medicare beneficiaries with low back pain, putting patients at risk of serious complications with no evidence of clinical benefit.
Its analysis focused on high-volume hospitals that performed at least 500 spinal fusion/laminectomy or vertebroplasty procedures over a 3-year period — finding more than 200,000 unnecessary procedures amounting to about $1.9 billion in wasted Medicare spending during that time.
“We’re not doing this just to draw attention to the fact that there is unnecessary surgery,” Lown president Vikas Saini, MD, told MedPage Today. “We’re doing it to track how much, so people who want to do something about it have a guideline.”
As for the doctors who are performing these unnecessary procedures, Saini said there are “true believer” surgeons who insist that the procedure can benefit their patients despite a lack of evidence, “and there are those who are more skeptical. … But let’s be magnanimous and say that all of this comes from a place of wanting to help, and hope that it will help.”
“But if we’re really going to have a reliable, effective, and affordable healthcare system, we can’t just base it all on hope and a prayer,” he said. “It has to be based on evidence. Hope is easy to have, but in the end, it doesn’t solve the problem.”
The report also noted the high rate of complications from these procedures. Some 18% of spinal fusion procedures result in infection, blood clots, stroke, pneumonia, heart and lung problems, and in some cases, death.
The Lown Institute’s list was taken from Medicare data. The hospitals with the highest rates of spinal fusion/laminectomy overuse are Mount Nittany Medical Center in Pennsylvania (57.2% of 505 procedures), Concord Hospital in New Hampshire (39.5% of 517 procedures), and Lutheran Hospital of Indiana (38.6% of 1,232 procedures).
The hospitals with the highest rates of vertebroplasty overuse included Kettering Health Miamisburg in Ohio (56.1% of 578 procedures), Shannon Medical Center in Texas (54.6% of 694 procedures), and St. Elizabeth Florence Hospital in Kentucky (50.1% of 668 procedures).
The report also applauded hospitals with the lowest rates of these procedures. Avala Hospital in Louisiana, Northwest Specialty Hospital in Idaho, and Baylor Surgical Hospital at Las Colinas in Texas all had spinal fusion/laminectomy overuse rates of 1.2% or lower. Metrohealth Medical Center in Ohio, Harborview Medical Center in Washington, and the Mayo Clinic Health System-La Crosse were among 11 hospitals with no vertebroplasty overuse.
The hospitals with high rates of overuse have not returned a request for comment from MedPage Today.
The report also highlighted enormous state variation in rates of overuse of these procedures. California, Florida, Texas, and Pennsylvania had the highest amount of overuse of spinal fusion procedures, with at least 5,000 unnecessary procedures in each state. Texas, Florida, and Ohio had the highest volume of vertebroplasty overuse with at least 6,000 unnecessary procedures in each of those states.
Spinal fusion/laminectomy procedures were considered overused when performed for low back pain, but excluded patients with radicular symptoms, trauma, herniated disc, discitis, spondylosis, myelopathy, radiculopathy, radicular pain, or scoliosis.
Spinal fusion-only procedures were not considered overused when performed for stenosis with neural claudication and spondylolisthesis. Laminectomy-only interventions were not considered overused when performed in patients with stenosis who had neural claudication.
Vertebroplasty procedures were considered overused when performed in patients with spinal fractures caused by osteoporosis, but the list excluded patients with bone cancer, myeloma, or hemangioma.
The Medicare data included fee-for-service patients’ procedures from 2021 to 2023 and Medicare Advantage patients’ procedures from 2020 to 2022. Procedures performed on Medicare beneficiaries under age 65 were not included.
Saini said the report concentrated just on those hospitals that performed at least 500 of these procedures. For the spinal fusion/laminectomy analysis, 466 hospitals were evaluated, and for vertebroplasty, 625 hospitals were included.
He said these procedures are extremely expensive, costing $14,500 for spinal fusion and $4,200 for vertebroplasty.
Asked what efforts he thinks will reduce the number of these unnecessary back pain procedures, Saini suggested federal oversight, such as the WISeR (Wasteful and Inappropriate Service Reduction) model, could have a larger role, perhaps with more targeted prior authorization requirements or guidelines. Yet he acknowledged that pathway is extremely controversial.
“There’s no way we can replace clinical judgment of the physician in the exam room,” Saini said. “We can’t have the federal government practicing medicine.”
But a lot of clinicians “just aren’t with the program and some of them will argue with you until they’re blue in the face that the data just doesn’t refute the way they practice,” he said, noting the saying, “It’s hard to get somebody to understand something when their salary depends on them not understanding.”
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https://www.medpagetoday.com/neurology/painmanagement/117842
The opioid analgesic tramadol reduced chronic pain levels compared with placebo, but appeared to double the risk of harm, a review of 19 clinical trials suggested.
In a meta-analysis and trial sequential analysis, tramadol improved chronic pain on the numerical rating scale (NRS) with low certainty of evidence (mean NRS difference -0.93 points, 97.5% CI -1.26 to -0.60, P<0.0001), said Jehad Ahmad Barakji, MD, of the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, and co-authors.
The effect size was below the predefined minimal important difference of 1.0 point, Barakji and colleagues wrote in BMJ Evidence-Based Medicine. The NRS evaluates pain on a scale of 0 (no pain) to 10 (worst pain imaginable).
Tramadol also raised the risk of serious adverse events (OR 2.13, 97.5% CI 1.29-3.51, P=0.001) with moderate-certainty evidence, driven mainly by a higher proportion of cardiac events and neoplasms, the researchers reported. Non-serious adverse events like nausea, dizziness, constipation, and somnolence were higher with tramadol.
“Approximately 60 million individuals worldwide experience the addictive effects of opioids,” observed co-author Janus Christian Jakobsen, MD, PhD, also of the Centre for Clinical Intervention Research.
“Tramadol continues to be widely prescribed for the management of chronic pain and is often perceived as safer than other opioids, although this perception lacks supporting evidence,” Jakobsen told MedPage Today.
“The use of tramadol and other opioids should be minimized as much as possible,” he added. “Our study provides evidence in support of this recommendation.”
Tramadol selectively binds to various opiate receptors in the central nervous system, similar to other opioids. It was first approved as a non-controlled analgesic in 1995 under the brand name Ultram.
In 2014, the Drug Enforcement Administration classified tramadol as a schedule IV controlled substance, indicating it had a lower risk of abuse and dependence than schedule II opioids like oxycodone and hydrocodone.
Tramadol is approved to treat pain severe enough to require an opioid analgesic and carries a boxed warning for addiction and abuse, life-threatening respiratory depression, and other potential harms. Total prescriptions for tramadol-containing products in the U.S. totaled 27.1 million in 2024.
“Tramadol is an interesting drug because there is a sense among many clinicians that it isn’t really an opioid,” noted Molly Jeffery, PhD, of the Mayo Clinic in Rochester, Minnesota, who wasn’t involved with the analysis.
In 2019, Jeffery led a large U.S. insurance claims study that showed patients who used tramadol alone after surgery had a higher risk of prolonged opioid use than expected.
“If tramadol really is very different from other opioids we give people for acute pain, we might expect to see differences in long-term use of opioids in people who are prescribed tramadol versus other opioids after surgery,” Jeffery pointed out.
“We found the opposite was true; people who got tramadol rather than oxycodone or hydrocodone after their surgery were actually more likely to continue using opioids long-term,” she told MedPage Today.
Barakji and colleagues assessed data from 19 clinical trials involving 6,506 participants with chronic pain in their systematic review with meta-analysis and trial sequential analysis. Five trials evaluated tramadol for neuropathic pain, nine focused on osteoarthritis, four assessed chronic low back pain, and one involved fibromyalgia.
Participants were ages 47 to 69; their mean age was 58. All trials involved oral tramadol except one osteoarthritis trial that used topical administration.
Treatment duration ranged from 2 to 16 weeks, and follow-up spanned from 3 to 15 weeks. Eight trials assessed serious adverse events after follow-up periods that ranged from 7 to 16 weeks.
Serious adverse events in the tramadol groups included chest pain, coronary artery disease, congestive heart failure, prostate cancer, breast cancer, and thyroid neoplasm. The follow-up period for neoplasms was short, making a causal link between tramadol and new cancer disease “questionable at this point,” the researchers noted.
Five trials that evaluated tramadol’s effect on quality of life had mixed results; two found improvements, and three reported no significant differences between tramadol and placebo.
The study had several limitations, Barakji and co-authors acknowledged. “All included trials were at high risk of bias except two, which increases the likelihood that our findings overestimate the beneficial effects and underestimate the harmful effects of tramadol,” they wrote.
Several trials did not report the specific types of serious adverse events, and follow-up length varied across trials.
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can you elaborate why the MME system has no valid clinical basis for being used in treating chronic pain pts – especially intractable chronic pain pts. And elaborate on how observational studies cannot replace the reliability of a double blind clinical study with a control group
Let’s break down your two important points:
The MME system is a way to compare doses of various opioids by converting them to a “morphine equivalent” value. This system was intended to help with opioid prescribing and safety policies, but using it as a rigid clinical tool—particularly for patients with chronic or intractable pain—has major problems:
MME Ratios Are Estimates: Conversions between different opioids are based on population averages and not on robust, head-to-head clinical trials. They ignore big differences in individual metabolism and response.
Lack of Accounting for Tolerance & Variability: Two patients on the same MME dose may have very different pain relief or risk of side effects.
No Validation for Chronic Use: MME tables were derived mainly from studies on acute pain or end-of-life care, not from well-controlled trials in treating chronic, stable pain patients.
Intractable Pain Complexity: Patients with intractable pain often require long-term, stable dosing, and conversion tables don’t reflect the clinical nuances or needs of this population.
Key point: There is no strong clinical evidence—no large, well-designed, double-blind, controlled trials—showing that fixed MME thresholds reduce overdoses or improve outcomes in chronic pain management.
Observational studies look at correlations or trends in real-world data. They can suggest possible risks or associations but cannot prove causation. For example, they might show that higher MME doses are associated with overdose, but they can’t control for all factors (like patient frailty, disease severity, or other medications).
In contrast, a double-blind, randomized controlled trial (RCT) assigns patients to treatments randomly and hides the assignment from both providers and patients. This design is considered the gold standard for minimizing bias and isolating the actual effect of the intervention.
Summary:
Observational studies can generate hypotheses, but they can be heavily confounded by outside variables. They CANNOT establish a reliable cause-and-effect relationship.
Policy decisions about pain management—like rigid MME limits—should be based on evidence from controlled trials, not observational trends alone.
Quick check: Can you restate, in your own words, the difference between what an observational study can tell us, and what a double-blind randomized controlled trial (RCT) is designed to show?
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The lawsuit against the three major drug wholesalers—McKesson, Cardinal Health, and AmerisourceBergen (now Cencora)—centered on their alleged role in fueling the opioid crisis by oversupplying opioids while failing to adequately monitor and report suspicious orders. Here is a breakdown addressing your questions in detail:drugtopics+2
The largest actions against the distributors resulted in multibillion-dollar settlements rather than full trials for most states and local governments. Notably, the national settlements required the distributors to pay up to $21 billion over 18 years, with related settlements from manufacturers and pharmacies as well. However, some cases did advance to trial, such as the recent suit by the City of Baltimore, which went to trial in September 2024 against McKesson and Cencora, after the city opted out of the national settlements. Jury selection began, and Johnson & Johnson settled just before trial.nationalopioidsettlement+2
A landmark jury verdict in Ohio, tried by Mark Lanier and others, found three major pharmacy chains liable for public nuisance, but the largest wholesaler cases were generally resolved by negotiation rather than completed trials.lanierlawfirm
High-profile prosecution firms for city and county cases included Susman Godfrey (Bill Carmody for Baltimore), Mark Lanier (The Lanier Law Firm) for Ohio counties, in coordination with public prosecutors and the U.S. Department of Justice in certain criminal or civil cases. DOJ trial attorneys, such as Drew Pennebaker and Devon Helfmeyer, also played key roles in prosecuting some distributor executives directly.reuters+2
State Attorneys General pursued these cases to address the opioid crisis via financial penalties and injunctive relief. There is no public indication that they specifically considered or analyzed the indirect economic impact on individuals owning stock in these companies via 401(k), Roth IRA, or other investments as a central argument; their focus was primarily on public health and restitution for state and local damages caused by the opioid epidemic.texasattorneygeneral+2
The settlement agreements required significant changes in how the wholesalers and pharmacies handle, track, and report opioid shipments. These include clearinghouses for order data, stricter suspicious order reporting, and independent oversight. The agreements did not directly mandate a reduction in overall controlled medication availability for patients with legitimate medical need, but experts and patient advocacy groups raised concerns about possible unintended consequences for access, as increased regulatory scrutiny can sometimes lead to overcorrection and restricted legitimate access.nationalopioidsettlement
There is no clear evidence in public settlement documents that formal consultation with medical specialists determined whether the settlement terms would cause a substantial reduction in access for patients with medical necessity. This lack of clinical input and concern about patient harm was highlighted by various chronic pain advocacy organizations, but these perspectives were not central to the Attorney Generals’ negotiation teams.nationalopioidsettlement
If you want further detail on a particular trial, the clinical oversight issue, or the mechanics of the abatement funds, more specific documents or court records would be needed.
Since the expiration of the Decade of Pain Control and Research Law around 2010, thousands of lawsuits—over 3,000 legal actions—have been filed against pharmaceutical companies, chain pharmacies, drug wholesalers, and other parties over their alleged roles in the opioid epidemic. Major defendants include Purdue Pharma, Endo, Mallinckrodt, Teva, Janssen, Cardinal, McKesson, AmerisourceBergen, CVS, Walgreens, and Walmart, among others.naag+3
Collectively, opioid-related settlements in the United States have reached more than $57 billion as of mid-2025, including state and local government agreements with all major industry entities. This figure encompasses the sums from landmark cases, multistate settlements, and agreements with manufacturers, distributors, pharmacy chains, and ancillary companies.opioidsettlementtracker+4
Despite these massive lawsuits and settlements, opioid overdose and poisoning deaths have not significantly declined and have actually increased, representing the so-called “opioid paradox.” While prescription opioid availability has been reduced by over 50% since the 2010-2012 peak (Indiana, for example, peaked at 112 prescriptions per 100 residents in 2012), overdose deaths have continued to rise, particularly those involving illicit fentanyl, heroin, and synthetic opioids. Studies show that reductions in opioid prescriptions and improved monitoring have led to fewer deaths from prescription opioids (“natural opioids”), but also forced many dependent individuals toward street drugs with higher overdose risk.ncbi.nlm.nih+3
Policy interventions reduced deaths from prescribed opioids, but overdose mortality overall increased as illicit opioid deaths surged.jamanetwork+1
Prescription opioid volume dropped ~50% since their peak, but overall opioid overdose/poisoning deaths increased dramatically.naco+2
Expansion of naloxone distribution funded by settlements helped reduce deaths modestly, but not enough to offset rising deaths from illicit opioids.jamanetwork+2
Examining the years since prescription opioid prescribing peaked (2010-2012), overdose deaths increased, mainly due to the transition to illicit fentanyl and heroin.sciencedirect+1
Some supply-side interventions against prescription opioids in states like Florida “sharply reduced oxycodone-related mortality and hospitalizations,” but nationwide trends show a rise in synthetic opioid deaths after prescription controls.ncbi.nlm.nih+1
Naloxone expansion has a positive effect by reducing fatal overdoses by up to 9%-37% locally, but it does not reverse the overall upward trajectory of deaths driven by fentanyl.jamanetwork+2
Lawsuits Filed (2010-2025) | Amount Awarded | Change in Opioid ODs Since 2012 | Effect of Rx Opioid Reduction |
---|---|---|---|
Over 3,000motleyrice+2 | >$57 billionopioidsettlementtracker+2 | OD/poisonings increasedsciencedirect+2 | Natural opioid ODs down, illicit ODs upjamanetwork+1 |
Overall, while lawsuits delivered billions for public health, they have not meaningfully reduced total opioid overdoses or poisonings. The crackdown on prescription opioids led to a shift in risk, not a net reduction in deaths, highlighting complex unintended consequences in opioid policy since 2010.jamanetwork+2
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I find myself typing the same answers to pt’s inability to get their pain meds and numerous other things that untold number of pain pts are experiencing in trying to get their pain properly managed.
I have added a new tab on the front page of my blog ACTIONS. I will be adding to the information under this tab going forward.
This tab will take pts to a new blog page that will basically be a index to numerous informational posts.
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can you define in detail what is pt abandonment when a intractable chronic pain pt is the pt and it is well known that it is unlikely that the pt will be able to find a new practitioner and the pt has been a pt of the practitioners for a minimum of several years
When an intractable chronic pain patient is abandoned by a healthcare practitioner, especially after a long-term relationship and with the knowledge that the patient will struggle to find a new provider, the concept and severity of abandonment are heightened under both ethical and legal standards.pmc.ncbi.nlm.nih+2
Patient abandonment occurs when a provider unilaterally terminates a longstanding relationship with a chronic pain patient—often dependent on complex therapies like opioids—without providing adequate notice, transition support, or referrals, and in cases where there are substantial barriers to the patient obtaining ongoing care.norcal-group+3
For chronic pain patients, “adequate notice and support” must acknowledge the real-world difficulty of finding a replacement provider, especially given widespread reluctance among clinicians to assume care for opioid-treated pain patients.usatoday+2
Terminating care for these patients places them at acute risk of unmanaged pain, opioid withdrawal, and serious physical or psychological harm, including possible hospitalization or suicide.academic.oup+2
Disproportionate Barrier to Alternative Care: It is recognized that chronic pain patients, especially those on long-term opioids, face “near-impossible” odds finding a willing new practitioner, making the duty to provide proper transition support more critical.jamanetwork+1
Severity and Duration of Relationship: A multi-year clinical relationship increases the provider’s duty of care and legal liability; the patient’s trust and dependency built over years amplifies harm if care is abruptly discontinued.pmc.ncbi.nlm.nih
Consequences of Lack of Care: The abrupt cutoff of essential pain treatment can result in significant suffering, potential life-threatening complications, emergency department visits, and increased risk of death.academic.oup+2
Legal frameworks increasingly view abandonment of chronic pain patients—where continuity is essential and alternatives are scarce—as a form of medical malpractice and unprofessional conduct, with both civil liability and possible board disciplinary action.spigalaw+1
Practitioners are expected to provide extended notice, clear written referrals, active assistance in securing new care, and, if necessary, interim prescriptions or emergency care access during the search for a new provider.clinician+2
In summary, for intractable chronic pain patients, abandonment by a longtime practitioner with knowledge of their vulnerability is regarded as a particularly egregious breach, potentially resulting in medical, legal, and ethical consequences far exceeding those in more typical cases of care termination.consumershield+3
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Hypothetical – pt has been seen in a practice for several decades by one particular practitioner. The pt is a intractable/high impact chronic pain pt being on opioids and other controlled substances for several decades. The practitioner that as taken care of this pt and a couple of other thousands with individualized therapies. This practitioner is retiring and the 10-12 practitioners in the group have decided to create a “cook book formula ” for treating chronic pain pts. this one particular pt is facing having her stable opioid therapy cut by 33% if the pt wishes to remain as a pt in the practice. Apparently, there is going to be no appeal to dosing decision. Most all of these pts are disabled/handicapped. Isn’t there some Medicare/Medicaid, HHS, CMS or ADA rules about such discrimination against disabled people
Yes, there are protections under federal law—including the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, and Centers for Medicare & Medicaid Services (CMS)/HHS rules—against arbitrary, discriminatory policies that target disabled patients, including those with chronic pain who are stable on opioid or controlled substance therapy.
ADA Prohibitions: The ADA prohibits discrimination against individuals with disabilities—including chronic pain patients—in places of public accommodation, including medical offices. Blanket policies refusing care or medication adjustments for all disabled/chronic pain patients, without individualized assessment, can constitute prohibited discrimination.
Reasonable Accommodation: Medical providers must engage in an interactive process and provide reasonable accommodations for disabled individuals, unless doing so poses a direct threat or undue burden. This includes considering continued individualized pain management rather than enforcing a rigid “cookbook” protocol.
Federal Examples: The ADA guidance explicitly states that, if a doctor’s office has a blanket policy of denying care or altering medication for patients with specific disabilities—such as opioid use disorder (OUD) or chronic pain—that blanket refusal may be illegal discrimination.
Patient Rights: CMS and Medicare rules require that care be individualized based on medical necessity, and blanket downward adjustments in dosing with no appeal process may violate coverage and patient rights provisions.
Appeals and Documentation: While Medicare Part D does allow safety edits and restrictions on opioid prescriptions, it also supports appeals, exceptions, and mandates careful documentation for patients requiring ongoing higher-dose opioid therapy for legitimate disabling pain.
Chronic Pain Patient Focus: CMS encourages careful, documented, and medically necessary opioid use for chronic pain, and continued therapy for functionally impaired/disabled individuals is recognized when justified clinically.
Discriminatory Impact: HHS and the Interagency Pain Task Force have warned that non-individualized, “formulaic” protocols for opioid therapy risk patient harm and can be seen as discriminatory towards disabled populations, particularly when patients do not have recourse to individualized review or appeal.
Blanket policies that cut opioid dosing for all chronic pain or disabled patients—especially with no pathway for individualized assessment or appeal—may violate the ADA and other federal regulations. Such practices could expose the practice or health system to legal action, enforcement by the Office for Civil Rights, complaints to Medicare/HHS, and even civil litigation.
If a patient or advocate feels discriminated against, filing an ADA complaint with the Department of Justice (DOJ), Office for Civil Rights (OCR), or CMS may be warranted—documentation of individualized medical need and the impact of the rigid policy will be essential.There are indeed federal rules that prohibit medical discrimination against people with disabilities, including those with high-impact chronic pain and functional impairment:
ADA (Americans with Disabilities Act): It is illegal for medical practices to use blanket “cookbook” policies that deny access to individualized pain treatment for patients with disabilities, such as intractable chronic pain. The ADA requires reasonable accommodation and individualized assessment, particularly if a policy disproportionately impacts the care of a protected group and there is no medical justification based on individualized care.
CMS/Medicare and Medicaid Rules: These programs mandate individualized medical necessity and allow for appeals or exceptions for beneficiaries needing long-term opioid therapy for legitimate disabling pain. While safety edits and monitoring exist, abrupt policy-driven cuts without clinical justification (and appeal rights) may violate patient protections under CMS regulations.
OCR/HHS Guidance: HHS, through the Office for Civil Rights and the Interagency Pain Task Force, has specifically warned that policies which do not allow for individualized review of opioid and pain care can risk being discriminatory if they disproportionately harm disabled populations; complaints about such discrimination can be made to the federal government.
Blanket, non-individualized dosing policies—especially when targeted only at those with chronic disabling pain—are vulnerable to ADA and CMS complaints and could trigger civil rights investigations or legal action. Practices must provide a pathway to individualized assessment and appeal, or risk violating federal anti-discrimination law.
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