Surgeons Billed $2 Billion for Unnecessary Spine Surgeries: Report

 More than 200,000 Medicare patients with back pain underwent $2 billion worth of unnecessary surgeries, including spinal fusion and/or laminectomy or vertebroplasty, over a recent 3-year period, according to an analysis

opens in a new tab or window of Medicare claims data from the Lown Institute.

If unnecessary, such procedures put patients at risk of blood clots, pneumonia, heart and lung issues, infections, paralysis, and death. After surgery, 10% to 40% of patients experience "failed back surgery syndrome," in which the vertebrae do not fuse back together, the report said.

"The times in which spinal fusion and laminectomy work for spinal stenosis is when the stenosis is causing neurogenic claudication, or radicular symptoms, meaning you're getting pain shooting down the leg; the nerve is pinched," Vikas Saini, MD, president of the Lown Institute, told MedPage Today. "But if you don't have that ... and you just have spinal stenosis without that pain, then those surgeries have not been shown to be effective."

Spinal fusion is recommended for patients with low back pain caused by traumatic injury, sciatica, slipped spinal bone, or spinal deformity. The report excluded spinal fusion/laminectomy surgeries from those considered unnecessary if the claim documented radicular symptoms, trauma, herniated disc, discitis, spondylosis, myelopathy, radiculopathy, radicular pain, scoliosis, neural claudication, or spondylolisthesis.

"For patients who have low back pain caused by aging, there is not sufficient evidence of a benefit from these procedures compared to non-surgical alternatives," the report noted.

Vertebroplasty procedures were defined as overused for patients with spinal fracture caused by osteoporosis. Patients with bone cancer, myeloma, or hemangioma were excluded from those considered to have undergone unnecessary procedures.

When the Lown Institute removed claims for which there was good reason for the surgery, "we are still left with a lot of cases that were unnecessary," Saini said.

When Saini was asked if surgeons or the people who submitted claims on their behalf could have made mistakes, were lazy, or didn't check the right ICD-10 diagnosis codes, he noted that there could be some of that, but not nearly in the numbers that the institute found.

Saini was also asked why Medicare would pay for procedures without diagnostic justification.

"The answer about why Medicare pays is because Medicare doesn't really use appropriateness criteria to decide whether to pay," he replied. "Maybe that's the real big story here. Why does the Lown have to do this? Because nobody else does."

The Lown report does not name the surgeons performing these potentially unnecessary procedures, but it does draw an association between large sums of money paid by the spine surgery industry to surgeons "with measurable spinal fusion/laminectomy or vertebroplasty overuse." For example, NuVasive and Medtronic paid physicians $8 million and $7.5 million, respectively, from 2020 through 2022.

Charles Rosen, MD, of the University of California Irvine and a specialist in spine surgery who was not involved in producing the report, found its conclusions credible.

It captures "the practice of operating on low back pain without any of the qualifiers that indicate a legitimate need for surgery -- neurogenic compression or compression of the nerve, scoliosis, spondylolisthesis, tumor, [or] fracture," he told MedPage Today.

"It's really not terribly accepted in academic circles to operate on just back pain or discogenic disease when you have no real etiology for the pain," he said.

Rosen also echoed Saini's comment that Medicare just pays for everything. "It's called pay and chase. They approve everything and that's where the huge amount of abuse for Medicare comes in."

He noted that there's been a number of studies that showed that losing weight, stopping smoking, and engaging in healthier activities is a better treatment for back pain when you don't have a specific diagnosis, like nerve compression or deformity.

Rosen also pointed to the heavy influence that the spine surgery equipment industry has on hospitals and surgeons. "I mean, spinal hardware is $1,000 a screw and you put in three or four levels, you can get $20,000, $30,000 of equipment put in."

In the report, the hospitals with the highest rates of unnecessary spinal fusions/laminectomies included:

• Mount Nittany Medical Center in State College, Pennsylvania: 62.8%
• Medical Center of Aurora in Colorado: 42.1%
• Jefferson Abington Hospital in Abington, Pennsylvania: 40.6%
• Concord Hospital in New Hampshire: 40.6%
• Heritage Valley Sewickley in Pennsylvania: 40.1%

Hospitals with high rates of unnecessary vertebroplasty included:

• Shannon Medical Center in San Angelo, Texas: 55.5%
• Chi St. Vincent Infirmary in Little Rock, Arkansas: 50.5%
• St. Elizabeth Florence Hospital in Florence, Kentucky: 48.7%
• Lutheran Hospital in Fort Wayne, Indiana: 44.6%
• Ascension Providence Hospital in Southfield, Michigan: 42.3%

The report also named hospitals with low rates of unnecessary spinal fusion/laminectomy procedures, which included Avala Hospital in Covington, Louisiana (0.1%); Northwest Specialty Hospital in Post Falls, Idaho (1.2%); Fresno Surgical Hospital in California (1.2%); Baylor Surgical Hospital at Las Colinas in Irving, Texas (1.3%); and Christus Mother Frances Hospital in Tyler, Texas (1.7%).

Several hospitals had no claims for unnecessary vertebroplasty procedures, including MetroHealth Medical Center in Cleveland; Essentia Health - St. Joseph's Medical Center in Brainerd, Minnesota; Marshall Hospital in Placerville, California; and Denver Health Main Campus in Colorado.

There was also wide variation in unnecessary procedures from state to state. For example, hospitals in New Hampshire, Iowa, Massachusetts, Pennsylvania, Alabama, and Hawaii had the highest average rates of unnecessary spinal fusion/laminectomy procedures, while Arkansas, Kansas, Oklahoma, Nevada, Nebraska, and Indiana had the highest average rates of unnecessary vertebroplasty procedures.

For the report, overuse was measured using Medicare fee-for-service claims data from 2020 to 2022 and Medicare Advantage claims data from 2019 to 2021. The cost of unnecessary back surgeries was calculated using Medicare's procedure price lookup tool for outpatient procedures, using the most frequent Current Procedural Terminology code for the procedure. The cost of inpatient procedures was calculated using the average Medicare cost of the most frequent Diagnosis Related Group code for the procedure, using Medicare fee-for-service claims data.

None of the hospitals contacted for comment responded as of press time.

https://www.medpagetoday.com/special-reports/features/112902

'Surge in Alcohol-Related Liver Transplants in Younger Adults'

 Rates of alcohol-induced liver disease (AILD)-related hospitalizations and liver transplants surged over the past two decades, with particularly steep increases among younger adults in recent years, an analysis of U.S. data showed.

From 2005 to 2021, hospitalizations for AILD doubled from 63 to 129 per 100,000 women, while increasing from 187 to 302 per 100,000 men, reported Michele Molinari, MD, MSc, of UPMC Montefiore in Pittsburgh, and colleagues.

And over that time, rates of liver transplant related to AILD rose from 1.9 to 8.4 per million women and from 10.4 to 20.1 per million men (P<0.001 for all trends). Significant increases for hospitalizations and transplants were seen across sex and age groups, the team detailed in JAMAopens in a new tab or window.

"Although older males had the highest absolute increases, the greatest relative increases occurred in younger individuals, particularly females," wrote Molinari and co-authors. Hospitalizations among younger women increased by a relative 283% during the study period as liver transplants increased by 2,284%. Younger men had increases of 169% and 684%, respectively.

"These findings highlight an important need to elucidate the biopsychosocial factors driving alcohol use and formulate preventive strategies targeted to younger individuals, especially females," the authors concluded.

Excessive alcohol use was responsible for 20% of the deathsopens in a new tab or window in adults ages 20 to 49 in the years leading up to the pandemic, noted Molinari and colleagues. And by all accountsopens in a new tab or window, the COVID pandemic has only made things worseopens in a new tab or window. One study, for example, showed a 22% increase in deaths related to alcohol use disorderopens in a new tab or window in 2021 compared with projected numbers.

Decompensated AILD is the top indication for liver transplant, but a lack of data exist on demographic factors associated with AILD and AILD-related transplant, according to the researchers, who sought to evaluate trends in recent years.

For their study, Molinari's team used the National Inpatient Sample (NIS) to look at AILD-related hospitalizations and the Scientific Registry of Transplant Recipients for AILD-related liver transplants from 2005 to 2021. NIS data were weighted to calculate national estimates.

They found 6.5 million AILD-related hospitalizations during that time, 71% of which were in men; 13% were in younger adults (ages 20 to under 40), while 87% were in older adults (ages 40 and older).

Among the younger patients in the study, hospitalizations related to AILD tripled from 34 per 100,000 in 2005 to 102 per 100,000 in 2021 (increasing from 19.5 to 74.8 in younger women and from 47.9 to 128.9 in younger men). For the older patients, AILD-related hospitalizations increased from 178 to 273 per 100,000 (from 88.6 to 157.1 in women and from 278.9 to 403.41 in men).

Of the 27,447 AILD-related liver transplants, 75% were in men and 90% involved the older group of adults.

Among the younger patients, liver transplants increased tenfold, from 0.7 per million in 2005 to 7.3 per million in 2021 (increasing from 0.2 to 5.3 in younger women and from 1.8 to 9.2 in younger men). Transplants in older patients nearly doubled, from 9.2 to 17.8 per million (from 2.8 to 10 in women and from 16.5 to 26.5 in men).

As a limitation of the study, Molinari and colleagues pointed out that the NIS tracks hospitalizations rather than individual patients. They also could not account for the potential influence of obesity or viral hepatitis.

Disclosures

Molinari had no disclosures. A co-author reported fees from Gilead, AbbVie, GSK, Novo Nordisk, and Boehringer Ingelheim.

Primary Source

JAMA

Source Reference: opens in a new tab or windowSethi V, et al "Trends in hospitalizations and liver transplants associated with alcohol-induced liver disease" JAMA 2024; DOI: 10.1001/jama.2024.21503.

https://www.medpagetoday.com/gastroenterology/livertransplantation/112900

'New FDA Rules for TV Drug Ads: Simpler Language and No Distractions'

 The ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look, as new rules require drugmakers to be clearer and more direct when explaining their medications' risks and side effects.

The FDA spent more than 15 yearsopens in a new tab or window crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information.

Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms.

"Some people become very attached to social media influencers and ascribe to them credibility that, in some cases, they don't deserve," said Tony Cox, MBA, professor emeritus of marketing at Indiana University.

Still, TV remains the industry's primary advertising format, with over $4 billion spent in the past year, led by blockbuster drugs like the diabetes and weight-loss treatment semaglutide (Ozempic, Wegovy), according to ispot.tv, which tracks ads.

Simpler Language and No Distractions

The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when describing their drugs, without medical jargon, distracting visuals, or audio effects. A 2007 law directed the FDA to ensure that drug risk information appears "in a clear, conspicuous, and neutral manner."

FDA has always required that ads give a balanced pictureopens in a new tab or window of both benefits and risks, a requirement that gave rise to those long, rapid-fire lists of side effects parodied on shows like "Saturday Night Live."

But in the early 2000s, researchers began showing how companies could manipulate images and audio to de-emphasize safety information. In one example, a Duke University professor found that ads for the allergy drug mometasone (Nasonex), which featured a buzzing bee voiced by Antonio Banderas, distracted viewers from listening to side effect information, making it harder to remember.

Such overt tactics have largely disappeared from drug ads.

"In general, I would say the ads have gotten more complete and transparent," says Ruth Day, PhD, director of the medical cognition lab at Duke University and author of the Nasonex ad study.

The new rules are "significant steps forward," Day said, but certain requirements could also open the door to new ways of downplaying risks.

Information Overload?

One requirement instructs companies to show on-screen text about side effects while the audio information plays. A 2011 FDA study found that combining text with audio increased recall and understanding.

But the agency leaves it to companies to decide whether to display a few keywords or a full transcript.

"You often cannot put all that on the screen and expect people to read and understand it," Day said. "If you wanted to hide or decrease the likelihood of people remembering risk information, that could be the way to do it."

Viewers tend to tune out long lists of warnings and other information. But experts who work with drug companies don't expect those lists to disappear. While the guidelines describe how the information should be presented, companies still decide the content.

"If you're a company and you're worried about possible FDA enforcement or product liability and other litigation, all your incentives are to say more, not less," said Torrey Cope, a food and drug lawyer who advises companies.

Experts also say the new rules will have little effect on the overall tone and appearance of ads.

"The most salient element of these ads are the visuals, and they are uniformly positive," said Cox. "Even if the risk message is about, for instance, sudden heart failure, they're still showing someone diving into a swimming pool."

Patient Influencers

The new rules come as Donald Trump's advisers begin floating plans for the FDA and the pharmaceutical industry.

Robert F. Kennedy Jr.opens in a new tab or window, an anti-vaccine activist who has advised the president-elect, wants to eliminate TV drug ads. He and other industry critics point out that the U.S. and New Zealand are the only countries where prescription drugs can be promoted on TV.

Even so, many companies are looking beyond TV and expanding into social media. They often partner with patient influencers who post about managing their conditions, new treatments, or navigating the health system.

"They're teaching people to live a good life with their disease, but then some of them are also paid to advertise and persuade," said Erin Willis, PhD, who studies advertising and media at the University of Colorado Boulder.

Advertising executives say companies like the format because it's cheaper than TV and consumers generally feel influencers are more trustworthy than companies.

FDA's requirement for truthful, balanced risk and benefit information applies to drugmakers, leaving a loophole for both influencers and telehealth companies like Hims, Ro, and Teladoc, who may not have a direct financial connection to makers of the drugs they're promoting.

The issue has attracted attention from members of Congress.

"The power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their healthcare professional," Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) wrote the FDA in a February letter.

A recently introduced billopens in a new tab or window from the senators would bring influencers and telehealth companies clearly under FDA's jurisdiction, requiring them to disclose risk and side effect information. The bill also would require drugmakers to publicly disclose payments to influencers.

"It's asking the FDA to take a more serious stance with this kind of marketing," said Willis. "They know it's happening, but they could be doing more and their regulations haven't been updated since 2014."

https://www.medpagetoday.com/publichealthpolicy/fdageneral/112903

Gabapentinoids Tied to Hip Fractures in Older Adults

 

• Gabapentinoids -- pregabalin and gabapentin -- were tied to increased hip fracture risk in older adults.
• Risks were high for people with chronic kidney disease or significant frailty.
• Odds of hip fracture remained high after adjusting for other central nervous system medications.

Gabapentinoids -- gabapentin (Neurontin) and pregabalin (Lyrica) -- were tied to an increased risk of hip fracture in older adults.

In a population-based analysis of more than 28,000 adults over age 50 who were hospitalized for their first hip fracture, the use of gabapentinoids was associated with increased odds of hip fracture (OR 1.96, 95% CI 1.66-2.32), reported J. Simon Bell, PhD, of Monash University in Melbourne, Australia, and co-authors.

Odds of hip fracture remained high after adjusting for exposure time and concomitant use of other central nervous system (CNS) medications (OR 1.30, 95% CI 1.07-1.57), the researchers wrote in JAMA Network Openopens in a new tab or window.

Subgroup analyses showed the association between gabapentinoid dispensing and hip fracture was high in people with Hospital Frailty Risk Scoresopens in a new tab or window of 5 or higher (OR 1.75, 95% CI 1.31-2.33) and in people with chronic kidney disease (OR 2.41, 95% CI 1.65-3.52).

"These findings suggest that in addition to the known risk associated with kidney impairment, gabapentinoids should be used with caution among patients at risk of hip fractures, especially those who are frail," Bell and colleagues wrote.

Despite limited indications, gabapentin and pregabalin are widely prescribed off-labelopens in a new tab or window for various syndromes, including chronic painopens in a new tab or window.

Gabapentinopens in a new tab or window is approved for seizures and nerve pain associated with shingles; gabapentin enacarbil is approved for restless leg syndrome. Pregabalinopens in a new tab or window is indicated for fibromyalgia and pain associated with diabetic peripheral neuropathy or spinal cord injury, in addition to seizures and post-herpetic neuralgia.

Common side effects of both drugs include drowsiness, dizziness, blurry or double vision, or difficulty with coordination and concentration.

"Gabapentinoids are actively transported across the blood-brain barrier and inhibit neurotransmitter release via multiple pathways," Bell and colleagues noted.

"This explains why gabapentinoids have efficacy for various central nervous system disorders, including seizures and neuropathic pain," they observed. "It is also why gabapentinoids have CNS adverse drug events including somnolence, dizziness, gait disturbance, and balance disorder. These adverse events may increase the risk of falls and fractures in older people."

Bell and co-authors used a case case-crossover analysis and a future case-control case-crossover analysis in their study to help minimize confounding.

In the case case-crossover analysis, the odds of dispensing gabapentinoids during an index period (1 to 60 days before the index date) were compared with the odds of dispensing in a reference period (121 to 180 days before the index date). To adjust for underlying trends in gabapentinoid use and to minimize persistent user confounding, each index case was matched with up to five controls, selected from future cases of the same age and sex.

The researchers assessed 28,293 patients ages 50 or older who were hospitalized for a first hip fracture in Australia from March 2013 through June 2018. The main analysis included 2,644 patients who had been dispensed gabapentinoids before being admitted; about 71% were women and more than half were ages 80 or older. Most were dispensed pregabalin.

The findings suggested that gabapentinoids were associated with a similar risk of hip fracture as other fall risk-increasing medications, Bell and co-authors noted.

"In addition to previous studies on antiseizure medications and fragility fractures, our study quantifies the specific risk associated with gabapentinoids. Such specificity is useful as fragility fractures vary widely in terms of treatment and prognosis, wherein hip fractures entail the largest morbidity and mortality burden," they wrote.

"In light of increasing gabapentinoid prescribing, our results have important implications for clinicians and policymakers," they added.

The study had several limitations, the researchers acknowledged. It measured medication dispensing, not whether the drugs actually were used. While most adverse effects related to falls -- like dizziness or somnolence -- were reported soon after gabapentinoids, the drugs also have long-term adverse effects on bone health due to interference with calcium homeostasis, they pointed out.

"Our results may, therefore, underestimate the overall effect of gabapentinoids on hip fractures," they stated.

Disclosures

This study was supported by a Dementia Australia Research Foundation-Yulgilbar Innovation Grant.

Bell reported relationships with the Dementia Australia Research Foundation, GlaxoSmithKline Supported Studies Programme, Amgen, Dementia Centre for Research Collaboration, National Health and Medical Research Council, Medical Research Future Fund, Victorian Government Department of Health and Human Services, Australian Government Department of Health and Aged Care, Yulgilbar Foundation, Aged Care Quality and Safety Commission, Pharmaceutical Society of Australia, and Society of Hospital Pharmacists of Australia.

Co-authors reported relationships with pharmaceutical companies and nonprofit groups.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowLeung MTY, et al "Gabapentinoids and risk of hip fracture" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.44488.

https://www.medpagetoday.com/neurology/painmanagement/112894

Halozyme interested in acquiring Evotec

 Evotec (EVO) is attracting potential takeover interest from Halozyme Therapeutics (HALO), Eyk Henning of Bloomberg reports, citing people familiar with the matter. Halozyme has recently expressed interest in acquiring Evotec at about EUR 11 per share, which would represent a 27% premium to Evotec’s closing price on Thursday and value the company at nearly $2.1B, sources told Bloomberg. Considerations are at an early stage and there’s no certainty they will lead to a deal, they added. Shares of Evotec jumped 10% to $5.02 following the report while Halozyme dropped 3% to $56.60.

https://www.tipranks.com/news/the-fly/halozyme-interested-in-acquiring-evotec-for-2-1b-bloomberg-says

Vertex started at Buy by Citi

 Target $575

https://finviz.com/quote.ashx?t=VRTX&ty=c&ta=1&p=d

Gilead started at Buy by Citi

 Target $125

https://finviz.com/quote.ashx?t=GILD&p=d