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Sunday, October 2, 2022

Calls to Team Heart Failure Specialists With Cardiac Critical Care

 With the needs of advanced heart failure (HF) dwarfing the supply of skilled physicians, HF specialists and others are well-positioned to prove their value in the contemporary cardiac ICU (CICU) -- and the clock is ticking for training and accreditation to keep up.

The problem for the workforce is that CICU patients are increasingly complex and affected by HF. More and more people are entering CICUs with congestive HF and cardiogenic shock, accompanied by comorbid sepsis and liver failure and an increasing need for non-cardiac procedures such as bronchoscopy, mechanical ventilation, and renal replacement therapy.

"CICUs are becoming the HF unit whether people want to acknowledge it or not," said Jason Katz, MD, MHS, co-director of the CICU and MCS program at Duke University in Durham, North Carolina, during a discussion at the Heart Failure Society of America (HFSA) annual meeting.

Problems meeting the uniquely resource-intensive care needs of patients with advanced HF and mechanical circulatory support are exacerbated lately by pandemic-related staffing issues, according to Ann Gage, MD, director of the CICU at Centennial Medical Center in Nashville.

As there just aren't enough dual-boarded critical care cardiologists -- or critical care doctors in general, for that matter -- the hope is that advanced HF-trained cardiologists might help fill the talent gap in the CICU if they learn to manage critically ill patients during training.

Katz noted that he is dual boarded-certified in advanced HF and critical care. He contrast the fewer than 50 training spots each year for critical care cardiologists with the over 80 programs training one to five HF cardiologists ever year.

There are incentives for HF specialists to make the jump: during this period of dwindling appeal and job uncertainty in advanced HF as a career -- the "elephant in the room" -- HF doctors should strengthen their niche in critical care, suggested Rachna Kataria, MD, of Rhode Island Hospital and Brown University in Providence. Kataria is a recent advanced HF transplant cardiology (AHFTC) fellowship graduate.

"We need to rebrand ourselves...We're not just [ventricular assist device] and transplant physicians," said Kataria. "Critical care training should be a core competency at this point."

She said that HF fellows should get more clinical training in areas such as post-cardiac surgery management, mixed shock and neurologic emergencies, and palliative care. They should also enrich skills in intubation, bronchoscopy, airway and ventilator management, and anesthesia during their training, she added.

Ultimately, it will take leadership to implement safety initiatives and quality improvement studies to show that HF cardiologists are not a liability in critical care, but that they bring value to patients, according to Kataria.

Katz noted that the specific components in each program will need to be tailored to fit the institution's needs and demands.

He cited a proposed pathway in which interested trainees pass through internal medicine residency and general cardiology fellowship before reaching AHFTC fellowship embedding cardiac critical care. At the end, they can be board-certified in cardiology and AHFTC with a distinction in cardiac critical care, he said.

He acknowledged the barriers to getting doctors interested in the AHFTC-cardiac care fellowship -- training fatigue, relocation, and having fellows waiting another year before they can start paying off their student loans.

As such, some believe there is room for more nurse practitioners and physician assistants to step into the CICU team. These providers currently have few options for advanced HF-specific training, yet structures are being put in place to encourage them down this path.

The Mayo Clinic Arizona in Scottsdale has a 1-year physician assistant fellowship for advanced HF, which could serve as a model for future efforts, for instance. And the HFSA is also launching a HF certification specifically for advanced practice providers in the next few months, according to Shannon Cornell, A-NP, of Medical University of South Carolina in Charleston.

For now, Katz urged stakeholders to engage professional societies like the American College of Cardiology to develop new training pathways and determine what is necessary for the future of cardiac critical care.

"Until that time, it's the Wild Wild West," he said. "We're flying by the seat of our pants."


Disclosures

Katz, Gage, Kataria, and Cornell disclosed no relationships with industry.

Cholera kills at least seven in Haiti as disease returns

 

Haiti on Sunday said at least seven people have died of cholera in a surprise return of the disease that comes as the nation is paralyzed by a gang blockade that has triggered shortages of fuel and clean drinking water.

The disease killed some 10,000 people through a 2010 outbreak that has been blamed on a United Nations peacekeeping force. The Pan American Health Organization in 2020 said Haiti had gone a year with no confirmed cholera cases.

"According to the information we have, the number of deaths is about 7 to 8," he said, adding that officials were struggling to get information from hospitals. "There was one death during the day today."

The Health Ministry earlier confirmed one case in the Port-au-Prince area and that there were suspect cases in the town of Cite Soleil outside the capital, which was the site of vicious gang turf wars in July.

Gangs have since last month been blocking the country's main fuel port in protest over last month's announcement of a fuel price hike. Many hospitals have shut down or scaled back operations for lack of fuel to power generators.

Basic transit is now impossible for most citizens.

Caribbean Bottling Company, a key supplier of bottled water, said on Sunday that it could no longer continue producing and distributing water because it had run out of diesel fuel, which is critical to its supply chain.

Cholera causes uncontrollable diarrhea.

The disease is typically spread by water contaminated with the feces of a sick person, meaning that clean drinking water is critical for preventing its spread.

Troops from Nepal, where cholera is endemic, were in Haiti as part of a U.N. peacekeeping force established in 2004 after the overthrow of President Jean-Bertrand Aristide. The force size was increased after Haiti's 2010 earthquake.

The United Nations in 2016 apologized for the outbreak, without taking responsibility.

An independent panel appointed by then-U.N. Secretary General Ban Ki Moon issued a 2011 report that did not determine conclusively how cholera was introduced to Haiti.

    The panel members in 2013 independently published an article that concluded personnel associated with the U.N. peacekeeping mission were "the most likely source."

https://www.marketscreener.com/news/latest/Cholera-kills-at-least-seven-in-Haiti-as-disease-returns--41910230/

Court orders HHS to vacate 340B payment discounts through 2022

 340B hospitals picked up a win Wednesday when a federal judge ordered that “defective” payment cuts for the drug discount program be tossed for the remainder of 2022.

U.S. District Judge Rudolph Contreras’ ruling addresses the first of two remedy questions stemming from June’s Supreme Court decision, in which the top court overturned a nearly 30% rate cut adjustment the Department of Health and Human Services (HHS) first introduced in 2018.

The Supreme Court unanimously rejected HHS’ argument that it did not need to survey hospitals’ acquisition costs before introducing the adjustment. The case was returned to lower courts to address potential remedies.

Hospital industry plaintiffs including the American Hospital Association (AHA), the Association of American Medical Colleges and America’s Essential Hospitals filed motions seeking to remedy years of unlawful underpayments to 340B hospitals and to vacate the 340B reimbursement rate of the Outpatient Prospective Payment System (OPPS) rule still in effect through the end of the year.

Addressing the latter, Contreras granted hospitals’ motion to vacate the 2022 reimbursement rate without injunction.  

The judge said HHS’ claims that vacatur of the 2022 rate would be disruptive were persuasive. HHS itself admitted that the remainder of 2022 accounts for “only … a small sliver of the overall time periods challenged in this action,” Contreras wrote, and the department has already begun taking steps to address a potential budgetary shortfall resulting from the Supreme Court’s ruling.

“In short, the Court finds that any disruption that will be caused by vacating the prospective portion of the 2022 OPPS Rule's 340B reimbursement rate does not rise to the level of justifying remand without vacatur,” the judge wrote.

Hospital industry stakeholders applauded the court’s decision.

“This is an important victory for 340B hospitals that have been fighting these unlawful Medicare cuts for nearly six years,” Maureen Testoni, president and CEO of 340B Health, which counts 1,400 hospitals as members. “The Centers for Medicare & Medicaid Services (CMS) has the clear responsibility to restore the appropriate payments for 340B drugs immediately, and now a federal court has ordered it to do so without delay.”

The immediate halt will help hospitals continue to provide services to their communities, AHA General Counsel and Secretary Melinda Hatton said in a statement already looking ahead to the court’s next decision.

“We continue to urge the administration to promptly reimburse all the hospitals that were affected by these unlawful cuts in previous years and to ensure the remainder of the hospital field is not penalized for their prior unlawful policy, especially as hospitals and health systems continue to deal with rising costs for supplies, equipment, drugs and labor,” she said.

AHA submitted several court filings in August warning against a budget-neutral recoupment plan that would require hospitals unaffected by the cuts to foot the bill.

https://www.fiercehealthcare.com/providers/court-orders-hhs-vacate-340b-payment-discounts-through-2022-recoupment-prior-years-yet-be

Lexicon: New Data on Sotagliflozin's Effect on Reducing Recurrent Heart Failure

  • Data presented at the Heart Failure Society of America annual scientific meeting
  • New analysis adds to growing body of evidence in support of the use of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, in the treatment of heart failure


MeiraGTx: Phase 1/2 Data Show Safety, Vision Improvement in Retinitis Pigmentosa Gene Therapy

 MeiraGTx Holdings plc (Nasdaq:MGTX), a vertically integrated, clinical-stage gene therapy company, announced today the primary results from the Phase 1/2 study evaluating the investigational gene therapy botaretigene sparoparvovec (formerly AAV-RPGR) in patients with the inherited retinal disease X-linked retinitis pigmentosa (XLRP) associated with the retinitis pigmentosa GTPase regulator (RPGR) gene.

Treatment with botaretigene sparoparvovec was found to have an acceptable safety profile and efficacy assessments in this proof-of-concept study demonstrated improvements in retinal sensitivity, visual function and functional vision.1 These findings were presented in a late-breaking oral presentation today at the Retina Subspecialty Day program of the American Academy of Ophthalmology (AAO) 2022 Annual Meeting (Abstract #30071754) by Professor Michel Michaelides.

https://www.marketscreener.com/quote/stock/MEIRAGTX-HOLDINGS-PLC-44154954/news/Late-Breaking-Phase-1-2-Data-Demonstrates-Safety-Profile-of-Investigational-Gene-Therapy-Botaretigen-41905060/

Legend Biotech to Host 2022 R&D Day on Monday, October 3

 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced it will host its in-person and virtual Research & Development Day on Monday, October 3, 2022 at 10:00 a.m. ET at Andaz 5th Avenue in New York City. Please click here to register for the event.

The event will feature a comprehensive overview of our platforms and the latest developments in our pipeline through presentations from members of Legend’s senior leadership team:

  • Ying Huang, Ph.D., Chief Executive Officer

  • Guowei Fang, Ph.D., Senior Vice President, Global Head of Research and Early Development

  • Lida Pacaud, M.D., Vice President, Clinical Development

  • Steve Gavel, Vice President, Commercial Development, US & Europe

A live webcast and presentation will be available to investors and other interested parties on the Legend Biotech website under "Events and Presentations". A replay of the webcast can be viewed as early as 24 hours after the event.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide.

https://finance.yahoo.com/news/legend-biotech-host-2022-r-123000880.html

Universal Health Services : Patriot Support Programs Expands Military Advisory Board

 The Universal Health Services Patriot Support Programs provide treatment for active duty military, veterans and their families. Programs and services are specifically designed to address the effects of combat stress, post-traumatic stress, depression, substance use disorder and other behavioral health issues.

We announce the expansion of the Patriot Support Programs Advisory Board, welcoming new member Major General (Ret) Jerry L. Fenwick, U.S. Air Force, and Air National Guard. General Fenwick retired in 2021 after 35 years of service in both the U.S. Army and Air Force. His final assignment was as Director, Office of the Joint Surgeon and Surgeon General of the National Guard, Washington, D.C. His career as an Emergency Medicine Physician has included multiple deployments with a focus on austere medicine and patient movement. Following retirement, Dr. Fenwick became the Chief Medical Officer for Disaster and International Medicine for Longview Technology, Herndon, VA. He is also CEO of Marshall Creek Medical Consulting and Medical Director of 417 Healthcare, Springfield, MO.

"During 2021, we served more than 18,000 active-duty military personnel, veterans and family members across the Behavioral Health division, including through our designated Patriot Support Programs," said Matt Peterson, Executive Vice President and President, Behavioral Health Division. "With a focused and dedicated Advisory Board, further expanded to include the wisdom and talents of Major General (Ret) Fenwick, we will continue to enhance our offerings to ensure military personnel receive the support and care they need to succeed. I have personally served with General Fenwick and can speak to his relentless commitment to saving lives."

The Advisory Board is comprised of:

  • Master Chief Petty Officer of the Navy (Ret) Joe Campa, U.S. Navy
  • David Frost, Vice Admiral (Ret), U.S. Navy
  • The Honorable Michael Kussman, MC, Under Secretary for VA Health (Ret), Brigadier General, U.S. Army
  • Rear Admiral (Ret) William McDaniel, MC, U.S. Navy
  • James Roudebush, MC, Lieutenant General (Ret), U.S. Air Force