Category: Medical Industry

Inaccurate Anaesthesia Start Times Leading to Lost Revenue

Photo by Anna Shvets on Pexels

Inaccurately recording the start of anaesthesia care during a procedure is common and results in significant lost billing time for anaesthesia practices and medical centres, suggests a study being presented at the American Society of Anesthesiologists’ ADVANCE 2023, the Anesthesiology Business Event.

The anaesthesia start time (AST) must be documented from a computer logged into the electronic health record (EHR), and typically occurs once the patient is in the operating room (OR). However, the anaesthesiologist meets with the patient prior to their arrival in the OR and begins tasks that are vital to the procedure, such as administering pre-medication and attaching monitors, time which is is not typically recorded. Depending on the patient and procedure, adding two to five minutes to the AST when logging it would account for the preparation and transit time, researchers say.

“These seemingly minor inaccuracies of recorded AST can cost medical centres and anaesthesia practices hundreds of thousands of dollars in lost revenue,” said Nicholas Volpe Jr, MD, MBA, lead author of the study and an anaesthesiology resident physician at Northwestern University McGaw Medical Center, Chicago. “We suspect most anaesthesiologists are unaware that they aren’t recording AST accurately. It’s not a result of negligence, but rather reflects that workflow hasn’t been optimised for accuracy.”

For the study, the researchers analysed 40 312 procedures with anaesthesia over 12 months at a single academic centre. In 68.74% of cases , AST was recorded as starting once the patient was in the OR, without factoring in the preparation time. Using the national average charge for anesthaesia time, the missing time translated to over $600 000 in lost revenue for the year, the researchers determined.*

“Logging AST is one of the many new tasks that anaesthesiologists learn when starting a new role,” said Dr Volpe. “Transitioning from an internship to clinical anaesthesia practice involves learning a significant amount of new information, and understanding the importance of an accurately recorded AST may seem like a relatively minor issue compared to important patient-care information.”

Several approaches could help address inaccurate AST documentation, including educating anaesthesiologists on how to improve their AST recording practices and providing visual reminders such as signs in the OR, Dr Volpe said. Also, an AST capture function could be built into the EHR mobile application so that AST can be noted by anaesthesiologists on the way to the OR, or the EHR could automatically add two minutes to the AST log time, he said. The researchers plan to roll out some of those initiatives in the spring and determine if they are effective.

*The projected savings are theoretical and not linked to billing at the institution where the study was conducted. 

Source: American Society of Anesthesiologists

A New Wave of Academia Spinouts is Shaking up Drug Development

Photo from Pixabay

In recent times, new drug discoveries by independent large pharmaceutical companies have become increasingly rare, with almost 60% of new drugs discovered through mergers and acquisitions and drug licensing. Fortunately, an emerging trend of spinouts from academia and R&D investments heralds a promising shift in the industry’s interorganisational deal networks to improve research and development in the future. Researchers explore this new trend in Drug Discovery Today.

Launching a new drug in the market is risky, thanks to a low probability of success during the research and development (R&D) phase and the high costs involved. But through an improved understanding of disease biology, decision-making can be more streamlined through the effective use of scientific information.

With this in mind, researchers from Ritsumeikan University, Japan, led by Associate Professor Kota Kodama are uncovering how the trends in interorganisational deals in the pharmaceutical industry are changing to improve R&D productivity and drug discovery. “The network structure of innovation creation in the pharmaceutical industry has changed with the increasing emergence of start-up companies spinning out from academia and research institutions as players in the source of innovation,” explains Dr Kodama.

Their research suggests that the knowledge necessary for breakthrough innovation in drug discovery is more often than not obtained through alliance networks. Over the past decade, large research-based pharmaceutical companies have used research collaborations, innovation incubators, academic centres of excellence, public-private partnerships, mergers and acquisitions (M&As), drug licensing, and corporate venture capital funds as typical methods for external innovation. The researchers now aim to define the changes in the network structure and nature of such alliances that have occurred over the past decade to provide future strategic insights for industry and academic players involved in drug discovery.

Using data from the Cortellis Competitive Intelligence database, the researchers identified nearly 50 000 deals of various kinds related to pharmaceutical R&D across pharmaceutical, digital health software, animal drug, and medical device companies to uncover trends in the creation of new drugs for human use. They also studied the trends of 13 of the largest pharmaceutical companies with annual revenues of more than US$10 billion, who saw an improvement in their CAGR (compound annual growth rate) since 2015. The researchers noticed that the rising CAGR correlated to a significant change in M&A-related deals after 2015, indicating that M&A-related deals drive revenue growth for large pharmaceutical companies.

Furthermore, the number of organisations involved in interorganisational deals has been increasing yearly from 2012 to 2021. Although the number of organisations involved and the number of deals may be increasing, the density of the deal networks is decreasing annually, suggesting that networks are becoming more non-cohesive. The concentration of business relationships between organisations of certain areas in the network changed to dispersion around 2015, and new networks connecting different groups started to form after 2017. These trends are an important illustration of how the industry landscape is gradually evolving away from the traditional network in which large pharmaceutical companies drove drug discovery output. Now, interorganisational deals among more diverse players have become active and are driving R&D productivity for startups in biotechnology and pharmaceuticals.

A clear increase in the number of academia-owned spinouts of advanced technology and expansion of investment in start-ups is a positive sign. The emergence of new chemical modalities, such as biologics, oligonucleotides, and peptides that differ from traditional small molecule drug discovery indicate remarkable changes that have taken place over the past two decades. The trend of increased financing for start-up companies in personalised drug development is beneficial for patent creation and will positively impact innovation creation in the coming years.

“The presence of academia to support the technologies of these start-ups is becoming very important, and government and private support and investment in this area is boosting innovation. Our study shows that such medium- and long-term support may ultimately benefit the health and well-being of humankind,” concludes an optimistic Dr Kodama.

Source: Ritsumeikan University.

Health Care Integration Sees Ballooning Costs for Minor Care Benefit

Photo by Andrea Piacquadio on Unsplash

Over the past few decades, health care integration has absorbed physician practices and hospitals into large health systems, a practice which was heralded as the way to cut health care costs and boosting quality of care.

But integrated health systems appear to be failing on both fronts, according to the results of a new US study published in JAMA. For patients in health systems, care is only marginally improved while costs are significantly higher compared to those at independent practices or hospitals.

In the US, health systems have grown exponentially in size and market share through mergers and acquisitions of physician practices and hospitals and the joining of separate health systems.

Proponents of consolidation have argued over the years that physicians and hospitals working together in integrated, coordinated systems provide better patients care while being more efficient than independent physician practices and hospitals. This would drive quality of care up while keeping spending steady and even driving costs down.

“One of the key arguments for hospital mergers and practice acquisition was that health systems would deliver better-value care for patients. This study provides the most comprehensive evidence yet that this isn’t happening,” said study first author Nancy Beaulieu at Harvard Medical School.

Today, these systems are responsible for a large proportion of the medical care delivered in the US, some employing thousands of physicians. But despite their impact on population health and the economy, little is known about the actual performance of integrated health organisations, the study authors noted.

A lack of detailed data on performance and scale is a key obstacle. The current analysis is believed to be the first comprehensive national study to compare outcomes between patients receiving care within health systems and outside of them, including patients with private insurance as well as traditional Medicare, which is the US health insurance system for those over 65 or which certain disabilities or conditions. 

The analysis included a total of 580 health systems, accounting 40% of physicians and 84% of general acute care hospital beds. Academic and large nonprofit systems accounted for a majority of system physicians (80%) and system hospital beds (64%).

System hospitals were larger than hospitals than nonsystem ones, with 67% of system hospitals having more than 100 beds, while only 23% of nonsystem hospitals having more than 100 beds. System physician practices were also more likely to have more than 100 physicians compared with nonsystem practices (74% vs 12%). Integrated systems delivered primary care to 41% of traditional Medicare beneficiaries.

As for quality and cost of care delivered within systems, patients with primary care physicians in health systems reported slightly better satisfaction and overall care experience than patients of independent physicians.

This is the case even though many patients with nonsystem primary care providers also receive some of their care in hospitals or specialist practices that are part of a health system. However, care in systems came at a much higher price, contributing to higher overall spending on health care, the research showed.

Prices for services from physicians and hospitals within health systems were significantly higher than for independent healthcare, the study found. Physician services delivered within health systems cost between 12% and 26% more, compared with independent practices. System-based hospital services cost an average of 31% more than care delivered by independent hospitals.

Small differences in quality combined with large differences in cost of care suggests that health systems have not, on average, realised their potential for better care at equal or lower cost, the researchers said.

Members of the research team have compiled a database from various sources to help characterise these health systems and to link claims data with information on health care providers in and out of health systems. The database, housed at NEBR, will be made available for free to other researchers in the near future.

“There’s no question that large, sophisticated health systems have benefits over independent systems,” said study author David Cutler, Harvard economic professor. “Big systems tend to be less vulnerable to economic downturns and they can provide specialised care that would be difficult to maintain in smaller systems. But the hoped-for cost savings benefits of integrated health systems have not yet materialised.”

Source: Harvard Medical School

Can Fungi Transform Plastic Waste into Drug Components?

Photo by Louise Reed on Unsplash

Research on fungi has helped transform tough-to-recycle plastic waste from the Pacific Ocean into key components for making pharmaceuticals, using a genetically altered version of an everyday soil fungus, Aspergillus nidulans. The researchers described their chemical-biological approach in Angewandte Chemie, a journal of the German Chemical Society.

“What we’ve done in this paper is to first digest polyethylenes using oxygen and some metal catalysts – things that are not particularly harmful or expensive – and this breaks the plastics into diacids,” said co-author Berl Oakley, professor at the University of Kansas.

Next, long chains of carbon atoms resulting from the decomposed plastics were fed to genetically modified Aspergillus fungi. The fungi, as designed, metabolised them into an array of pharmacologically active compounds, including commercially viable yields of asperbenzaldehyde, citreoviridin and mutilin.

Unlike previous approaches, Oakley said the fungi digested the plastic products quickly, like “fast food.”

“The thing that’s different about this approach is it’s two things – it’s chemical, and it’s fungal,” he said. “But it’s also relatively fast. With a lot of these attempts, the fungus can digest the material, but it takes months because the plastics are so hard to break down. But this breaks the plastics down fast. Within a week you can have the final product.”

The KU researcher added the new approach was “bizarrely” efficient.

“Of the mass of diacids that goes into the culture, 42% comes back as the final compound,” he said. “If our technique was a car, it would be doing 200 miles per hour, getting 60 miles per gallon, and would run on reclaimed cooking oil.”

Previously, Oakley has worked with corresponding author Clay Wang of the University of Southern California to produce about a hundred secondary metabolites of fungi for a variety of purposes.

“It turns out that fungi make a lot of chemical compounds, and they are useful to the fungus in that they inhibit the growth of other organisms – penicillin is the canonical example,” Oakley said. “These compounds aren’t required for the growth of the organism, but they help either protect it from, or compete with, other organisms.”

Oakley’s lab at KU has honed gene-targeting procedures to change the expression of genes in Aspergillus nidulans and other fungi, producing new compounds.

The researchers focused on developing secondary metabolites to digest polyethylene plastics because those plastics are so hard to recycle. For this project, they harvested polyethylenes from the Pacific Ocean that had collected in Catalina Harbor on Santa Catalina Island, California.

“There’ve been a lot of attempts to recycle plastic, and some of it is recycled,” Oakley said. “A lot of it is basically melted and spun into fabric and goes into various other plastic things. Polyethylenes are not recycled so much, even though they’re a major plastic.”

The KU investigator said the long-term goal of the research is to develop procedures to break down all plastics into products that can be used as food by fungi, eliminating the need to sort them during recycling.

“I think everybody knows that plastics are a problem,” Oakley said. “They’re accumulating in our environment. There’s a big area in the North Pacific where they tend to accumulate. But also you see plastic bags blowing around – they’re in the rivers and stuck in the trees. The squirrels around my house have even learned to line their nest with plastic bags. One thing that’s needed is to somehow get rid of the plastic economically, and if one can make something useful from it at a reasonable price, then that makes it more economically viable.”

Source: University of Kansas

AcciCare and Standard Bank Partnership Makes Private Medical Care Accessible to all Commuters

Public transport is used by more than 10 million commuters in South Africa every day. It’s how people get to work, how they get to the grocery store, how they get their children to school. It’s quite simply a way of life.

For many of these commuters, there is no alternative to minibus taxis. They are an indisputably dominant pillar of the informal public transport system, but they are also notoriously unsafe. The constant threat of an accident is a real concern for commuters, especially those who cannot afford private medical aid.

“We live in a country where 73% of the population doesn’t have access to private medical aid. Couple this with the high number of road accidents in South Africa, and what recourse do the vast majority of commuters have if they are involved in a road accident?” asks Rikus Scheepers, managing director at AcciCare Medical Service Providers.

AcciCare is a medical funding company that assists people who do not have medical aid, to get access to private hospital care when they are involved in a motor vehicle accident. Scheepers started AcciCare in 2017, with the intention of making private medical care accessible to all commuters.

“We started AcciCare in a few hospitals and had limited capital to work with but soon realised the extensive need for this type of service. As a start-up without a long trading history, it became impossible to grow the business to meet the demand. We needed a business partner who shared our vision to supply this essential service throughout the country, and so we approached Standard Bank,” says Scheepers.

“AcciCare is a unique concept not offered in South Africa,” says Jocelyn Hamilton at Standard Bank. “When they approached us for finance we had to apply some out-the-box thinking in order to provide a working capital solution that would enable the business to grow and expand into more provinces in the country.”

In the event a person is injured in a motor vehicle accident, AcciCare will assist treating doctors and hospitals to collect and complete the correct documentation in order for medical costs to be claimed back from the Road Accident Fund (RAF). AcciCare provides financial assistance to these service providers, so they don’t carry the costs while waiting for the RAF to settle accounts.

“We firmly believe that all commuters should have access to private medical care when they need it the most. Through our partnership with Standard Bank we are expanding our footprint and we have exciting initiatives in place for 2023, to educate more people about the reliable private care that is available to them,” says Scheepers. “Together with Standard Bank, AcciCare has saved countless lives and has significantly improved the quality of life of those who have unfortunately been involved in a motor vehicle accident.”

“Our business banking model is centred on partnering with clients to grow their businesses in the communities in which they exist. While we came in as a working capital solution that would see AcciCare achieve their vision, in return we indirectly partnered in improving the long-term quality of life for those unfortunate enough to be in need of medical care at critical times. We hope to continue with this partnership, as they take their business to new heights,” says Hamilton.

Theranos Founder Elizabeth Holmes Sentenced to 11 Years for Fraud

Theranos’s Elizabeth Holmes in 2016
Credit: Tali Mackay at English Wikipedia, CC 4.0 license.

After a trial stretching out from before the COVID pandemic, Elizabeth Holmes, the former CEO of diagnostic biotech startup Theranos, has been sentenced to 11 years after being found guilty of fraud.

In 2018, she was indicted along with Ramesh “Sunny” Balwani on four counts of wire fraud and conspiracy to commit wire fraud in connection with the collapse of Theranos, and was found guilty in January this year. She had been seeking a retrial since she had been contacted by a key witness, former Theranos lab director Adam Rosendorff, who she claimed had recanted statements made under oath.

Before Theranos’s collapse, Rosendorff had previously supplied information for an investigative series into the struggling biotech firm’s Previously, the university dropout had been widely lauded as an innovator and an inspiration for women in technology.

In his remarks during the sentencing of Holmes, US District Judge Edward Davila said, “The tragedy of this case is that Ms. Holmes is brilliant. She had creative ideas. She is a big thinker. She was a woman moving into an industry that was dominated by, and let’s face it, male ego. That young women entrepreneurs are regrettably denied access to, but she made that.”

Judge Davila sentenced her to 135 months (11 years and three months) in prison. Holmes will report to serving her sentence on April 27, 2023, at a minimum-security women’s prison less than 160km from her native Houston, Texas.

Another Shortage Created by COVID: Macaques for Research Purposes

The pharmaceutical industry is facing a serious challenge as it struggles to source enough non-human primates (NHPs) such as macaques for research and testing. Alongside demand created by HIV/AIDS research, the pandemic has tightened supplies of the animals further as China, a major supplier, has clamped down on exports.

Since NHPs have great genetic and physiological similarity to humans, scientists use these animals, most commonly rhesus macaques, to study medical conditions and conduct trials which are not yet possible in humans. In 2019, US scientists used 68 257 NHPs in research, according to US government data.

As a result of this shortage, many projects may not be able to be completed, according to industry insiders, with implications for medical research. Pre-pandemic prices of $11 000 per macaque have risen to $35 000.

In July last year, Nature reported that the US government pledged to increase funding to make primates available for clinical research. However, this would not do anything to address the current shortage.

To make room for more NHPs, the US National Institutes of Health (NIH) has invested about US$29 million to refurbish housing, build outdoor enclosures and making other infrastructure improvements at the US National Primate Research Centers (NPRCs), which it funds. 

“A couple of years ago, we were feeling the pinch,” Nancy Haigwood, director of the Oregon NPRC in Beaverton, which houses about 5 000 non-human primates. But because of the pandemic, “we are truly out of animals”, she told Nature. “We’re turning away everyone.”

China had been a cheap source of cynomolgus macaques (Macaca fascicularis) since 1985, but in 2013 began to prioritise local research, restricting exports. Adding to this was soaring demand was sparked by multiple NIH grants awarded in 2016 to study HIV/AIDS, according to a 2018 report. Housing and feeding NHPs is costly, and NPRCs could not expand due to budget caps. The report warned of a coming shortage of various primates in coming years.

The situation has drawn the public’s attention – and opposition. Complaints made to airlines has resulted in many no longer carrying the animals, making transportation a major challenge. Air France was one of the last holdouts, and last year said it would stop carrying NHPs for research purposes.

With the arrival of the pandemic and the need for NHP research and testing, vaccine research was naturally prioritised, while trying to supply other projects as well.

When COVID hit, China completely suspended exports of macaques, hitting pharmaceutical companies hardest, which prefer that species for drug trials. Even if the export ban were to be lifted, the Chinese demand for macaques in research is so high that there would be few available for export: of 30 000 macaques that became suitable for use in research last year, 28 000 were used.

Other restrictions constrain the supply, such as a European Union requirement that all non-human primates for research come from self-sustaining colonies by November this year. The UK also carried through this directive following its exit from the EU.

The Same Medications for Humans are Pricier than for Pets

Photo by Pauline Loroy on Unsplash

In a research letter published in JAMA Internal Medicine, researchers compared the prices of 120 medications commonly used in humans and pets. The authors found human medication prices were typically higher than the price of pet medications – with the same ingredients at common human-equivalent doses.

While some medications are common to both pets and humans, but price differences can be extreme. In 1991, levamisole (introduced in the 1960s as a veterinary antiparasitic) demonstrated efficacy in treating human colon cancer. The introductory human price of Janssen’s Ergamisol (brand-name levamisole; $5 per 50mg tablet) was 100 times the then veterinary price (approximately $0.05 for an equivalent amount). With the COVID pandemic, a misinformation-driven demand for ivermectin as a COVID treatment led to people seeking veterinary formulations of the drug, increasing the price 15-fold over a month ($6 to $92 for 3 tubes). In this cross-sectional study, the researchers sought to compare prices of commonly prescribed medications used to treat both humans and pets.

The researchers from the University of Minnesota found that retail price for human medications was on average 5.5 times higher than pet medications. For more than 60% of medications, even discounted prices for humans were higher than pet prices. On average, discounted prices were 1.5 times higher for human medications than for pet medications.

‘’A 10-day supply of the same medication costs $2 for a pet dog, $10 for a person with a discount coupon, and $100 for a person without a coupon,” said Arjun Gupta, MBBS, assistant professor at the U of M Medical School and oncologist with M Health Fairview. He is also a member of the Masonic Cancer Center. “With many humans and pets uninsured or underinsured, it is important that cash prices for medications are affordable and that pricing is not exploitative.”

Human prices were also higher than pet prices for drugs such as antibiotics. Researchers warn this may promote humans sourcing antibiotics for their own use from pet sources, especially since human antibiotic use is more regulated.

Exactly why there is such a significant price difference is unclear. One possibility may be drug manufacturers engaging in price discrimination by charging consumers different prices in different markets for the same product, the researchers suggest. Additionally, price differences could reflect variations in medication effectiveness, willingness to pay, and manufacturing, storage, and regulatory standards.

Further research is suggested to explore the causes of price differences.

Source: University of Minnesota Medical School

Is the US Failing to Hold Crooked Medical Industry Execs Accountable?

Photo by Tingey Injury Law Firm on Unsplash

When it comes to violations of US federal law by pharmaceutical and medical device manufacturers, the US Department of Justice (DOJ) is not exercising its full authority, according to the findings of a review published in JAMA Internal Medicine.

The conviction of Elizabeth Holmes, CEO of the failed blood-testing company Theranos, has focused attention on the personal liability of corporate officers of medical companies engaging in illegal activity. Holmes was charged with defrauding and conspiring to defraud investors, patients, and physicians, each count carrying a maximum 20-year sentence. Among prosecutors’ allegations was that Theranos’ main blood-testing device failed to work as the company and Holmes had promised. While Holmes was convicted of defrauding investors, she faced no personal liability as a CEO responsible for a company knowingly selling faulty diagnostic tests.

When a drug or medical device company violates US federal law, the government can use the Park doctrine. It holds that a CEO for a health-related company has a “position of authority” in a profitable business selling “services and products [that] affect the health and well-being of the public.” The doctrine’s aim is to protect patients from harm caused by unsafe or fraudulent medical products and services. It does this by targeting the executives who run the companies that make revenues on these products while violating federal law.

This provides an alternative to having that risk borne by patients or impersonal corporate entities; however, it is rare for there to be public reports of drug and device company executives being prosecuted with Park doctrine.

The researchers sought to identify prosecutions using the Park doctrine and characterise their role in DOJ enforcement efforts related to medical product industry misconduct. To this end, they conducted a literature search.

They found 13 cases where executives from six drug and medical device companies prosecuted under the Park doctrine since 2000. These prosecutions resulted in 11 guilty pleas and two jury trials, leading to two convictions. Of the six companies, three were drug manufacturers, two were medical device manufacturers, and one was a compounding pharmacy. All three of the drug manufacturers were opioid manufacturers, of which two executives were charged for unlawful promotion, and one was charged for manufacturing errors. Both device manufacturer executives were charged with unlawful promotion. All but three prosecutions alleged the defendants’ complicity or personal involvement in the misconduct, which Park does not require. By contrast, most large settlements with the DOJ over alleged misconduct in the past two decades did not result in individual liability for executives.

“This review suggests that federal prosecutors have exercised far less than their full capacity under the Park doctrine to sanction problematic corporate behaviour that threatens patients and the public health,” the authors concluded. They suggest that enforcement under a reinvigorated Park doctrine would help to better protect patients.

Private Equity Firms Acquire Medical Practices and Squeeze Them for Profit

Photo by Marek Studzinski on Unsplash

New research has found that private equity firms that acquire physician-owned medical practices seem to be imposing measures to squeeze out more profits. After their acquisition by private equity firms, the clinics saw more patients and billed more for visits among a large, commercially insured population, according to a study published in JAMA Health Forum.

Researchers from Oregon Health & Science University and other institutions examined a total of 578 US physician practices specialising in dermatology, gastroenterology and ophthalmology that were acquired by private equity firms from 2016 to 2020.

“The reason this is of concern to patients and policymakers is that private equity is often driven by profit margins of 20% or more,” said senior author Jane M. Zhu, MD, assistant professor of medicine in the OHSU School of Medicine. “To do that, they have to generate higher revenues or reduce costs. Increasing private equity in these physician practices may be a symptom of the continuing corporatisation of health care.”

While it is unclear whether these practices hurt clinical outcomes for patients, the findings raise concerning parallels with the rapid growth of private equity acquisition of nursing homes and hospital systems.

“Private equity investment in nursing homes has been associated with an increase in short-term mortality and changes to staffing,” the authors wrote, citing previous research.

In the new study, researchers found an increase in the overall number of patients seen in these clinics. The study also reviewed commercial insurance claims data that showed an increased share of visits longer than 30 minutes, even though the complexity of cases remained similar to cases prior to being bought out.

“These billing patterns could mean more efficient documentation of services provided, or it could mean upcoding or up-charging insurance companies to make more money,” Asst Prof Zhu said.

She believes more evidence is needed about how private equity impacts practice patterns.

Recently, the same study team found that ~5% of US physicians are currently employed by private equity-owned practices. Researchers cited quality of care and patient satisfaction as key areas for future research as this trend continues.

“Private equity ownership of physician practices has added a distinctly private and market-driven influence to the broader trends in corporate consolidation of physicians by health systems and insurers,” they concluded. “This study contributes evidence for potential overutilisation and higher spending of care that will be important for policymakers to monitor.”

Source: Oregon Health & Science University