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Monday, February 13, 2023

Doctors Are Disappearing From Emergency Rooms as Hospitals Look to Cut Costs

 Pregnant and scared, Natasha Valle went to a Tennova Healthcare hospital in Clarksville, Tennessee, in January 2021 because she was bleeding. She didn't know much about miscarriage, but this seemed like one.

In the emergency room, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ER on three consecutive days, generating three separate bills, before she saw a doctor who looked at her bloodwork and confirmed her fears.

"At the time I wasn't thinking, 'Oh, I need to see a doctor,' " Valle recalled. "But when you think about it, it's like, 'Well — dang — why didn't I see a doctor?' " It's unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she's still paying the bills.

The hospital declined to discuss Valle's care, citing patient privacy. But 17 months before her three-day ordeal, Tennova had outsourced its emergency rooms to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its ERs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.

This staffing strategy has permeated hospitals, and particularly emergency rooms, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as "midlevel practitioners," who can perform many of the same duties and generate much of the same revenue for less than half of the pay.

"APP has numerous cost saving initiatives underway as part of the Company's continual focus on cost optimization," the document says, including a "shift of staffing" between doctors and midlevel practitioners.

In a lab at Lipscomb University, nurse practitioners join doctors in practicing how to place a chest tube to fix a collapsed lung by snaking a rubber hose through a rack of pork ribs. The NPs will have to perform the procedure under a doctor’s supervision before being allowed to do it on their own.

In a statement to KHN, American Physician Partners said this strategy is a way to ensure all ERs remain fully staffed, calling it a "blended model" that allows doctors, nurse practitioners and physician assistants "to provide care to their fullest potential."

Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from ERs may not be good for patients.

working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 ERs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.

Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients' time in the ER by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.

The study also found that ER patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.

Yiqun Chen, who is an assistant professor of economics at the University of Illinois-Chicago and co-authored the study, said these findings are not an indictment of nurse practitioners in the ER. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.

"It's not just a simple question of if we can substitute physicians with nurse practitioners or not," Chen said. "It depends on how we use them. If we just use them as independent providers, especially…for relatively complicated patients, it doesn't seem to be a very good use."

Chen's research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in ERs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care — not in the emergency department — increased the out-of-pocket costs to patients while also leading to worse performance on nine of 10 quality-of-care metrics, including cancer screenings and vaccination rates.

But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Dr. Cameron Gettel, an assistant professor of emergency medicine at Yale. Private equity investment and the use of midlevel practitioners rose in lockstep in the ER, Gettel said, and in the absence of game-changing research, the pattern will likely continue.

"Worse patient outcomes haven't really been shown across the board," he said. "And I think until that is shown, then they will continue to play an increasing role."

For Private Equity, Dropping ER Docs Is a "Simple Equation"

Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in three to seven years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.

Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.

At a two-day company training put on by American Physician Partners, chief medical officer Dr Tony Briningstool teaches doctors and nurse practitioners how to safely use sedation in the emergency department. As a money-saving strategy, emergency rooms are employing fewer doctors and relying instead on midlevel practitioners.

Two firms dominate the ER staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs ERs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.

These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Dr. Robert McNamara, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University.

"It's a relatively simple equation," McNamara said. "Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible."

Not everyone sees the trend of private equity in ER staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change — to use more nonphysician providers — is driven by the staffing firms' desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.

"Though I see that shift, it's not about profits at the end of the day," Orozco said. "It's about the patient."

The "shift" is nearly invisible to patients because hospitals rarely promote branding from their ER staffing firms and there is little public documentation of private equity investments.

Dr. Arthur Smolensky, a Tennessee emergency medicine specialist attempting to measure private equity's intrusion into ERs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ER patients were seen in ERs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.

Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ER has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ER on their own, he said.

"Most of us didn't go into medicine to supervise an army of people that are not as well trained as we are," Smolensky said. "We want to take care of patients."

"I Guess We're the First Guinea Pigs for Our ER"

Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.

It was 2020, and American Physician Partners was restructuring the ER where Allen worked, reducing shifts from two doctors to one. Once Allen had placed 10 tubes under a doctor's supervision, he would be allowed to do it on his own.

"I guess we're the first guinea pigs for our ER," he said. "If we do have a major trauma and multiple victims come in, there's only one doctor there. … We need to be prepared."

Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.

Generally, they have master's degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.

The Neiman Institute found that the share of ER visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in ERs by 2030.

There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.

Private equity can make millions in the gap.

For example, Envision once encouraged ERs to employ "the least expensive resource" and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision's website.

Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a "concept guide" that does not represent current views.

American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company's profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.

https://www.medscape.com/viewarticle/988196

Drug Combo Promising in Vascular Cognitive Impairment: LACI-2

 A combination of two drugs has shown promising results, including a reduction in cognitive impairment in patients who have had a lacunar stroke, and is seen as a new therapeutic approach for patients with cerebral small vessel disease.

The drugs — isosorbide mononitrate and cilostazol — stabilize endothelial function, which is a new therapeutic target for patients with small-vessel disease stroke.

The phase 2 LACI-2 study, evaluating these drugs individually and in combination in patients with lacunar stroke, showed promising trends toward reductions in recurrent stroke, cognitive impairment, and dependency, some of which became significant when the drugs were given together. There was also some suggestion of positive impacts on mood and quality of life.

"Isosorbide mononitrate was associated with a reduction in recurrent stroke, a tendency toward a reduction in dependency and a reduction in cognitive impairment, and cilostazol also seemed to reduce dependency," study investigator Joanna M. Wardlaw, MD, professor of applied neuroimaging at Edinburgh University, Edinburgh, UK reported.

"When used together, they seemed to have more benefits than either drug on its own. So this is good preliminary evidence that the drugs are working together in a positive way," she commented to theheart.org | Medscape Cardiology.

But she cautioned that these potential benefits will need to be confirmed in a larger phase 3 trial.

The LACI-2 study was presented February 9 at the International Stroke Conference (ISC) 2023 in Dallas by Wardlaw and co-investigator Philip Bath, DSc, professor of medicine at the University of Nottingham, Nottingham, UK.

They both highlighted the effect seen on cognitive impairment.

"We saw a significant reduction in the number of patients with cognitive impairment with the two drugs together in this phase 2 study," Wardlaw said. "This is very encouraging since no study has previously found any medications that positively affect cognitive impairment in small-vessel disease strokes. We cautiously hope that these medications may have wider implications for other types of small vessel disease as well."

Bath added: "The results on cognitive impairment are particularly important. Many patients rate cognitive impairment as one of the most dreaded outcomes of a stroke even if they also have quite significant physical disability. People simply don't want to lose their memory and thinking ability."

"The results of LACI-2 also raise interesting questions about whether these drugs would be beneficial for other types of small vessel disease which do not present as stroke, but maybe may manifest as headaches or memory impairment," he noted.

"Very Intriguing Results"

Outside experts were enthusiastic about these preliminary results.

In an ISC highlights presentation, program chair Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, New Jersey, said: "It is refreshing to finally see some positive signals in studies in small vessel stroke. This is an area where we haven't had answers for a long time."

He described the reduction in cognitive impairment seen in the study as "very intriguing and very important."

"I think we have underestimated the burden that cognitive impairment has in stroke, and the burden in general in society of vascular cognitive impairment. This is a very promising approach that definitely deserves to be investigated more thoroughly in a larger trial."

Commenting for theheart.org | Medscape Cardiology, Mitchell Elkind, MD, professor of neurology and epidemiology at Columbia University Irving Medical Center, New York City, said this study "provides evidence that points us in at least two important directions."

"First, it suggests that endothelial dysfunction, or problems with the lining of the blood vessels, may be an important contributor to small vessel disease and the cognitive decline that often accompanies it. This is a new mechanism of action and different from blood clotting, blood pressure, and other conventional targets of treatment," Elkind said.

"Second, and more generally, it suggests that stroke trials, particularly in the subtype of small vessel disease, can and should explore not only the incidence of recurrent acute events but also the steady decline that occurs after stroke. Post-stroke cognitive decline is a relatively new area of stroke research."

Wardlaw noted that lacunar stroke is a common type of ischemic stroke, but it has been rather neglected in terms of research. It is assumed to be caused by atherosclerosis of the small vessel but there is now mounting evidence suggesting that it is a result of problems in the endothelium of the small vessels.  

"We looked for potential available drugs that targeted endothelial dysfunction. Both the drugs we tested are already widely used — isosorbide mononitrate for the treatment of coronary artery disease and angina, and cilostazol mainly in Asia for stroke prevention," she said.  

LACI-2 was primarily a feasibility study looking at whether it was possible to recruit enough patients who had had a lacunar stroke and would take the drugs, individually or in combination, for up to a year. Outcomes were investigated on an exploratory basis.

The study enrolled 363 patients who had experienced lacunar stroke from 26 stroke centers throughout the UK. They were randomly assigned to one of four treatment groups for 1 year:

  • 40 to 60 mg/day of oral isosorbide mononitrate alone

  • 200 mg/day of oral cilostazol alone

  • both medications

  • neither medication

Patients completed phone surveys at 6 and 12 months to assess health status, including recurrent stroke, myocardial infarction (MI), cognitive tests, symptoms, quality-of-life surveys, and they also had brain imaging at 12 months.

Results showed 98% of patients were still taking their study medication at 1 year and the drugs appeared to be safe on top of usual care with few deaths or hemorrhages in the study.

The composite outcome including recurrent stroke, MI, cognitive impairment, dependency (mRS >2) and death was reduced by 20% in the isosorbide mononitrate alone group (adjusted hazard ratio [HR] 0.80; 95% CI, 0.59 - 1.09).

The composite endpoint was reduced by 23% in the cilostazol group (HR 0.77; 95% CI 0.57 - 1.05) and by 42% in the combination group (HR 0.58, 95% CI, 0.36 - 0.92) compared with those taking neither drug.

Isosorbide mononitrate alone showed trends toward a reduction in recurrent stroke, cognitive impairment and dependency, whereas cilostazol alone reduced dependency with a trend toward a reduction in cognitive impairment. When used together, the drugs showed large reductions in cognitive impairment (HR 0.44; 95% CI, 0.19 - 0.99) and dependency (HR 0.14; 95% CI, 0.03 - 0.59).

During the highlights session, Jovin commented: "It is obvious that the investigators have put a lot of thought into the design of this trial. Presumably because of the composite score they were able to increase the power. We are used to trials which require thousands of patients but here we are able to see significant results, although exploratory, with just a few hundred patients."

Bath stressed that this was only a phase 2 study. "We now need to see if we can confirm these results in a larger phase 3 study." That study, LACI-3, is planned to start later this year.

Bath also suggested that it would be interesting to investigate whether these drugs would work in other types of ischemic stroke such as those caused by large artery disease or cardioembolic strokes, as well as other forms of small vessel disease such as patients with vascular cognitive impairment.

"There are many areas to investigate in future. It might be that in a few years' time these drugs may be standard of care across many different forms of small vessel disease," he said.

Wardlaw noted that lacunar strokes are generally quite mild strokes, which could be one of the reasons why they have not been the target of much research to date.

But Bath added: "While they may be labeled as a mild stroke on the NIHSS scale, patients can still be quite badly affected. About half of patients with a lacunar stroke develop cognitive impairment and eventually dementia — that is certainly not mild."

The study was funded primarily by the British Heart Foundation, with support from the UK Alzheimer's Society, the UK Dementia Research Institute, the Stroke Association, the Fondation Leducq, NHS Research Scotland, and the UK National Institutes of Health Research Clinical Research Networks. Bath is an advisor to CoMind, DiaMedica, Phagenesis, and Roche. Wardlaw reports no relevant financial relationships.

International Stroke Conference (ISC) 2023: Presentation LB4 and LB12. Presented February 9, 2023.

https://www.medscape.com/viewarticle/988201

US Conducts Aircraft Carrier Drills In South China Sea Amid Balloon Tensions

 by Dave DeCamp via AntiWar.com,

The US Navy and Marines Corps are conducting drills in the South China Sea amid heightened tensions between Washington and Beijing over the Chinese balloon incident.

The US Navy’s Seventh Fleet said in a statement that the aircraft carrier USS Nimitz and its strike group conducted the drills on February 11 with the 13th Marine Expeditionary Unit. The Seventh Fleet did not say when the drills started or when they would end.

The US has stepped up its military activity in the South China Sea in recent years and has formally rejected most of Beijing’s claims to the waters. China, the Philippines, and several other Southeast Asian nations all have overlapping claims to the South China Sea.

The US has involved itself in the dispute, and starting under the Obama administration, the US began sailing warships near Chinese-controlled islands in the South China Sea.

The Biden administration is looking to expand the US presence in the region and recently signed a deal with the Philippines that will give the US access to four more military sites in the country.

The current exercises come after China declined a call from Secretary of Defense Lloyd Austin following the US downing of the Chinese balloon. Washington claimed the balloon was a spy device, while Beijing insisted it was a weather balloon only used for civilian purposes.

Secretary of State Antony Blinken canceled a planned trip to China when the balloon was first announced by the Pentagon. Since the incident, the US military has shot down at least two unidentified objects, but the White House says they didn’t look like Chinese balloons.


DeSantis Announces Legislation To Ban Social Credit Scores, 'Woke ESG Financial Scam'

 Florida Governor Ron DeSantis (R) on Monday announced a proposal to eliminate ESG banking and prohibit the financial sector from implementing social credit scores that would otherwise prevent Floridians from obtaining loans, lines of credit and opening bank accounts.

"Today’s announcement builds on my commitment to protect consumers’ investments and their ability to access financial services in the Free State of Florida," said DeSantis in a statement. "By applying arbitrary ESG financial metrics that serve no one except the companies that created them, elites are circumventing the ballot box to implement a radical ideological agenda. Through this legislation, we will protect the investments of Floridians and the ability of Floridians to participate in the economy."


The proposal "seeks to protect Floridians from the woke ESG financial scam" by:

  • Prohibiting big banks, trusts, and other financial institutions from discriminating against customers for their religious, political, or social beliefs — including their support for securing the border, owning a firearm, and increasing our energy independence.
  • Prohibiting the financial sector from considering so called “Social Credit Scores” in banking and lending practices that aim to prevent Floridians from obtaining loans, lines of credit, and bank accounts.
  • Prohibiting banks that engage in corporate activism from holding government funds as a Qualified Public Depository (QPD).
  • Prohibiting the use of ESG in all investment decisions at the state and local level, ensuring that fund managers only consider financial factors that maximize the highest rate of return.
  • Prohibiting all state and local entities, including direct support organizations, from considering, giving preference to, or requesting information about ESG as part of the procurement and contracting process.
  • Prohibiting the use of ESG factors by state and local governments when issuing bonds, including a contract prohibition on rating agencies whose ESG ratings negatively impact the issuer’s bond ratings.
  • Directing the Attorney General and Commissioner of Financial Regulation to enforce these provisions to the fullest extent of the law.

"That is a way to try to change people’s behavior. It’s a way to try to impose politics on what should just be economic decisions," said DeSantis, of ESG. "We are also not going to house in either the state or local government level deposits. And we have a lot of deposit, we got a massive budget surplus in Florida, you have deposits all over the place that go in where state and local government use financial institutions, none of those deposits will be permitted to be done in institutions that are pursuing this woke ESG agenda."

As Florida's Voice notes,

The proposal would also aim to make sure ESG will not “infect decisions” at both the state and local governments, such as investment decisions, procurement and contracting, or bonds.

House Speaker Paul Renner said Bob Rommel, R-Naples, will introduce the bill in the House.

“The biggest thing that I think ESG represents is a total hijacking of democracy,” said Renner.

We’re lucky here in the state of Florida, that we’ve got a governor who will stand up to things like ESG, when others will not."

https://www.zerohedge.com/political/desantis-announces-legislation-ban-social-credit-scores-woke-esg-financial-scam

Vir Amends Collaboration Agreement with GSK

  Vir to continue advancing next-generation COVID-19 solutions independently or with other partners –

– The Companies will continue working together to ensure ongoing access to sotrovimab for patients around the world, where authorized, and to advance new therapies for influenza and other respiratory diseases –

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the research collaboration agreement established with GSK in 2020 has been amended to reflect that Vir will continue its ongoing efforts to discover, develop and advance next-generation solutions for COVID-19 and other potential coronavirus outbreaks, independently or with other partners. Together, the Companies will continue working to ensure ongoing access to sotrovimab for patients around the world, where authorized, and to develop new therapies for influenza and other respiratory diseases.

https://finance.yahoo.com/news/vir-biotechnology-announces-amended-collaboration-214500824.html

MacroGenics: Positive Presentation on Prostate Cancer Therapy Trial

 

  • Twelve of 42 patients (28.6%) in metastatic castration-resistant prostate cancer (mCRPC) cohort achieved ≥ 50% prostate-specific antigen (PSA) reduction (PSA50), including 9 (21.4%) who achieved ≥ 90% PSA reduction (PSA90)

  • Nine of 35 patients (25.7%) with measurable mCRPC achieved confirmed partial responses

  • Manageable overall safety profile observed across multiple expansion cohorts

  • Company plans to initiate Phase 2 study in mCRPC in 2023

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the dose expansion phase of the Company’s ongoing Phase 1 clinical trial of lorigerlimab, a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. This investigational molecule was designed to block PD-1 with enhanced CTLA-4 blockade on dual PD-1/CTLA-4-expressing cells, such as tumor-infiltrating lymphocytes (TILs), while maintaining maximal PD-1 blockade on all PD-1-expressing cells. The preliminary data is being presented in a poster titled “Lorigerlimab, a Bispecific PD-1 × CTLA-4 DART Molecule in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase 1 Expansion Cohort” (Poster #155) at the American Society of Clinical Oncology Genitourinary (ASCO-GU) Cancers Symposium taking place February 16-18, 2023, in San Francisco, CA.

Cohort Expansion Results Update

The ASCO-GU abstract included data as of September 10, 2022; updated data as of a December 12, 2022 cut-off are included below and will be presented at ASCO-GU.

As of the December 12, 2022 data cut-off, 118 patients with mCRPC, melanoma, non-small cell lung cancer or microsatellite-stable colorectal cancer were enrolled in the cohort expansion phase of the lorigerlimab Phase 1 study at the dose of 6.0 mg/kg, administered intravenously every three weeks (Q3W). Confirmed objective responses were observed across the histology-specific cohorts; preliminary efficacy results for mCRPC are presented in the poster and below.

Shortages Persist for Parenteral Nutrition

 Patients scrambling for the at-home parenteral nutrition they rely on for survival have made the news

opens in a new tab or window in recent days, but it's just another salvo in a decades-long struggle with supply.

"Shortages for parenteral nutrition are not new for clinicians," Phil Ayers, PharmD, chief of clinical pharmacy services at Baptist Medical Center in Jackson, Mississippi, told MedPage Today.

In the mid-1980s, clinicians started to see a a shortage of multivitamin products, he noted. And since about 2010, there have been shortages of essentially every single ingredient

Intravenous administration of nutrition is needed by a wide variety of patients -- young and old, hospitalized and ambulatory -- and for the gamut of nutrients

opens in a new tab or window from protein, carbohydrate, fat, minerals, and electrolytes to vitamins and other trace elements.

However, though life-saving for tens of thousands of patients who otherwise cannot eat or absorb enough food through tube feeding formula or by mouth to maintain good nutrition status long term as well as many more who may need it short-term, there continue to be shortages in parenteral nutrition.

"It's something that we've been dealing with in the nutrition world for a number of years," said Ayers, who is president-elect of the American Society for Parenteral and Enteral Nutrition (ASPEN). "It's oftentimes hit or miss, and you have to be very nimble."

That organization's website details what's currently in shortageopens in a new tab or window and provides recommendations to help clinicians manage those shortages, including how to dose appropriatelyopens in a new tab or window.

"Providing this therapy is particularly challenging for clinicians because PN [parenteral nutrition] is a complex medication and may contain 20 or more ingredients, of which multiple components may simultaneously be in limited supply," the website notes. "The availability of PN components must be considered during every step of the PN use process from ordering the PN prescription to administering this therapy to a patient. Unlike antibiotics, there are no therapeutic alternatives for missing PN components."

As of October 2022, parenteral components noted as in shortage by the FDA include amino acids and multivitamin infusion for adult and pediatric use as well as potassium chloride concentrate injection and sterile water.

The cause of these shortages range just as widely.

There can be regulatory issues or natural disasters that affect manufacturing plants, Ayers noted. Additionally, there have been voluntary recalls, issues with raw materials, the discontinuation of products by companies, and business decisions in favor of higher-profit manufacturing.

"We're one supply line, one hurricane, or one other company decision not to make this [away from] life-threatening shortages," agreed Paul Wischmeyer, MD, of Duke University School of Medicine and a member of the Society of Critical Care Medicine.

In 2017, for example, Hurricane Mariaopens in a new tab or window shut down key IV supply manufacturers in Puerto Rico. The pandemic caused system-wide shortagesopens in a new tab or window in parenteral nutrition primary ingredients. And last year, one of the largest providers, CVS Health, shuttered half of its Coram home infusion branchesopens in a new tab or window for home parenteral nutrition and "acute care" drugs such as IV antibiotics, refocusing on the more lucrative specialty IV medication market for autoimmune and other conditions. Another big supplier, Optum Rx, also consolidatedopens in a new tab or window its parenteral nutrition services in 2022.

Aside from the direct challenges that shortages lead to, Wischmeyer and others also noted that, whether it be a lack of availability of certain products, or lack of access to a local provider or supplier of parenteral nutrition where some may have left the market, hospitals can be left with patients who are ready to go home but cannot be discharged without at-home parenteral nutrition therapy arrangements.

"It's a huge problem," Wischmeyer said, calling for increasing medical education or subsequent training on clinical nutrition for physicians. Ayers also pointed to the importance of ongoing patient advocacy.

Amid ongoing shortages, the National Home Infusion Association (NHIA), which represents companies that provide therapies to patients as well as companies that manufacture and supply infusion related products and services, released a white paper outlining their findings on the issue.

"Shortages of PN [parenteral nutrition] ingredients and infusion-related disposable supplies resulted in substantial cost increases to infusion providers," the report states in part. "This was the case during the peak pandemic years, and despite some relief within the supply chain, persistent inflationary pressures have extended cost increases to the present day."

Connie Sullivan, CEO of the NHIA, pointed to one particular finding that the cumulative 5-year increase per bag of parenteral nutrition was about 50% over 2016 costs.

Sullivan told MedPage Today that there have been some companies that have reached a "tipping point," having not been "paid enough to stay in business and serve patients the way they need to be served."

Among the solutions put forward in the NHIA report is that payers consider the increased cost of items and services as they negotiate with providers to ensure payment reflects the complexity of care that is being provided.

"We need many providers offering services ... if we don't maintain that, we will have access issues," Sullivan said.

https://www.medpagetoday.com/special-reports/features/103085