Infectious Disease Groups Urge CMS to Retire Sepsis Treatment Guidelines

 The Centers for Medicare & Medicaid Services' (CMS) current guidelines for treating sepsis should be retired and replaced with more performance-based measures, according to a coalition of medical groups.

The measure, known as the Severe Sepsis and Septic Shock: Management Bundleopens in a new tab or window, or SEP-1, was first implemented by CMS in October 2015. In addition to being several dozen pages long, the measure has another unusual feature -- rather than being stewarded by the American Medical Association, CMS, or an infectious diseases association, its steward is Henry Ford Hospital in Detroit.

"The SEP-1 measure requires clinicians to provide a bundle of care to all patients with possible sepsis within 3 hours of recognition," the groups -- which include the Infectious Diseases Society of America (IDSA), the American College of Emergency Physicians, and the Society of Hospital Medicine -- said in a statementopens in a new tab or window. "The bundle includes drawing blood cultures, administering broad-spectrum antibiotics, and other measures. However, the SEP-1 measure does not take into account that many serious conditions present in a similar fashion to sepsis."

"Pushing clinicians to treat all these patients as if they have sepsis leads to overuse of broad-spectrum antibiotics, which can be harmful to patients who are not infected, those who are infected with viruses rather than bacteria, and those who could safely be treated with narrower-spectrum antibiotics," the statement continued. "Moreover, a series of studies published since the SEP-1 measure went into effect show that in practice SEP-1 has not lowered mortality rates."

"I don't think any of us who work in sepsis will deny it's a big problem, that hospitals should focus on it, and that there's room for improvement," Chanu Rhee, MD, MPH, an infectious disease physician at Brigham and Women's Hospital in Boston and lead author of the recommendations, said in a phone call. "But is SEP-1 the best way to do it, and are we causing unintended consequences by trying to treat everyone with possible sepsis immediately?"

"We think it's time to move beyond SEP-1 and move to metrics that focus on patient outcomes, so that will encourage hospitals to pay more attention to the full breadth of sepsis care," said Rhee, who is also an associate professor of population medicine at Harvard Medical School. "There are many things hospitals could do to improve [sepsis care] such as implementing processes to have timely source control, optimizing antibiotic dosing, de-escalation of antibiotics, minimizing sedation for patients who are mechanically ventilated, and preventing hospital-acquired infections. There are a lot of things that go into affecting outcomes for these patients that are getting neglected."

The recommendations, which were published Oct. 13 in Clinical Infectious Diseasesopens in a new tab or window, come just as CMS is increasing its importance in reimbursement. Hospitals have been required to report on their compliance with the sepsis guidelines, but in a final rule published in Augustopens in a new tab or window, CMS said that starting in fiscal year 2026, hospitals will be measured on how well they comply with the sepsis guidelines as part of the Hospital Value-Based Purchasing Program, and will risk losing money if their compliance isn't good enough.

This is not the first time the sepsis measure has come under fire. In May 2022, the National Quality Forum rejected an appealopens in a new tab or window of its endorsement of the SEP-1 measure. The forum, an affiliate of the Joint Commission, defines its role as helping to achieve consensus "on quality measurement and improvement standards and practices that achieve measurable health improvements for all."

The appeal, which was filed by several of the same groups that authored the new recommendations, came after the NQF had endorsed the measure in 2021 for the third time. The appellants expressed concern about the way the re-endorsement process had been handled.

At a virtual appeals board hearingopens in a new tab or window on April 29, Michael Klompas, MD, MPH, of Harvard Medical School, who spoke for the appellants, focused on the fact that two members of the appeals board were recused from participating due to conflicts of interest. "The apparent conflicts of interest, however, were nothing more than a deep interest in sepsis and having a record of having published technical critiques of SEP-1, including recommendations for possible modifications," he said. "These are not conflicts in our opinion, but rather bona fides that demonstrate these members' high-level interest and expertise in sepsis in SEP-1."

But measure co-developer Sean Townsend, MD, of California Pacific Medical Center, in San Francisco, had a different view. The recused board members "published articles critical of the sufficiency of the evidence supporting [the measure]," he said. "One of the measure evaluation criteria is the sufficiency of the evidence. These opinions conflicted with their duties to serve as impartial judges." In addition, said Townsend, "both committee members engaged in work with the measure developers. The NQF policy requires that if committee members have done so, that they must be recused."

CMS Administrator Chiquita Brooks-LaSure was asked about the sepsis issue during a video interviewopens in a new tab or window with MedPage Today Medical Editor-in-Chief Jeremy Faust, MD. "Will CMS heed the call of the nation's leading infectious disease experts and retire SEP-1 and replace it with something better?" Faust said.

"I can't speak to our future actions, but I do know how much we take what the scientific community says and what the clinical community says seriously," Brooks-LaSure replied. "We continue to review sepsis and other conditions."

The agency was more specific in response to an emailed query from MedPage Today. "CMS is reviewing the proposed recommendations in more detail," a spokesperson said. "However, at this time CMS believes the existing measure is most directly impactful to early evidence-based treatment of sepsis. CMS also notes that some of the recommendations appear to be challenging to implement on a national level because they are looking at interventions that are very dependent upon individual patient needs as opposed to a population of patients, such as optimizing antibiotic dosing."

https://www.medpagetoday.com/criticalcare/sepsis/107129

Siemens Healthineers Weighs Options for Diagnostics Arm

• German medical equipment group seeks to streamline operations
• In-vitro diagnostics business could fetch up to $8 billion

 

Siemens Healthineers AG is reviewing its diagnostics segment as the German company seeks to streamline its operations, people with knowledge of the matter said.

Frankfurt-listed Siemens Healthineers is working with advisers to study options for the division, according to the people. The review could lead to a sale or carveout of its in-vitro diagnostics operations, which test samples of blood and tissue to identify diseases and infections, they said.

https://www.bloomberg.com/news/articles/2023-11-02/siemens-healthineers-is-said-to-mull-options-for-diagnostics-arm

California healthcare provider's move shows pitfalls of Medicare Advantage

  Many people on Medicare look the other way when the program's annual enrollment period rolls around, preferring simply to ignore the hassle. But for thousands of seniors in San Diego, California, Medicare enrollment this year has become a confusing scramble to find new insurance - or new health providers.

Scripps Health, a major Southern California healthcare provider, announced in September that beginning next year, its popular clinic and coastal medical groups will no longer accept patients enrolled in Medicare Advantage, the managed-care alternative to traditional Medicare offered by commercial insurance companies. That has left 32,000 San Diego seniors rushing to find either new healthcare options or new insurance for 2024.

Disabled people who qualify for Medicare before they turn 65 also are affected. And Scripps is not alone - at least a half-dozen other health systems around the U.S. are terminating Advantage contracts.

Medicare's annual enrollment period is under way, and it ends on Dec. 7. If you are enrolled in traditional Medicare (Parts A and B) paired with a Medigap there is no need to review that coverage. But Part D prescription drug or Medicare Advantage coverage should be reviewed. This also is the time when you can move between Advantage and traditional Medicare. 

Medicare Advantage enrollment has grown quickly over the past decade, partly due to its all-in-one features and lower upfront costs. Most Advantage plans include prescription drug benefits, and they are not used alongside supplemental Medigap policies, which cover out-of-pocket costs and can be expensive. Like all Medicare beneficiaries, Advantage enrollees pay their Part B premium, and they are on the hook for out-of-pocket costs up to a pre-set annual ceiling. 

But the Scripps Health decision underscores an important downside to Medicare Advantage plans: there is no guarantee that you will be able to stick with your preferred doctors and hospitals. Medicare Advantage plans can drop healthcare providers from their networks - and that happens when providers and insurers cannot agree on contract terms.

The Scripps decision marks a new twist: healthcare systems deciding to drop out of Medicare Advantage. This inherent provider instability means that the choice between traditional Medicare and Advantage is not just financial - it is also a critical consideration for your health and quality of life.

When I spoke last week with Scripps Health CEO and President Chris Van Gorder, he noted that his institution is on track to lose $75 million or more on care it provides to Medicare Advantage patients this year. The two key issues that led to the decision to stop working with Advantage plans, he said, were the rates insurance companies were willing to pay, and the tendency of sicker patients to seek treatment at top-notch medical centers such as those run by Scripps.

He said that Scripps also has struggled with the administrative burden of dealing with Medicare Advantage "prior authorization" procedures - essentially, a process where an insurance company determines if it will cover a prescribed procedure, service or drug.

"This is probably the most difficult decision I have made in my role here," he said. "I'm in the patient care business, certainly not the insurance business and not the cancellation business."

The Scripps move has thousands of seniors scrambling, said Sophie Exdell, program manager of the San Diego area HICAP, which is California's State Health Insurance Assistance Program (SHIP). The SHIP program is funded by the federal and state governments, and it provides free, unbiased expert help with Medicare in all 50 states. 

"We're getting lots and lots of calls from people who are trying to figure out what to do," she said. "The most common concern is people who are in the middle of treatment and want to keep seeing their doctors." 

WEIGHING THE OPTIONS

But Scripps patients really have just two options: switch healthcare providers or insurance coverage.

During the annual enrollment period, it is possible to drop Medicare Advantage in favor of traditional, fee-for-service Medicare. But traditional Medicare has no built-in annual out-of-pocket limit. That means patients can be exposed to thousands of dollars in co-pays and deductibles. Many close these coverage gaps by purchasing a Medigap supplemental policy - but that can be a problem when you are moving to traditional Medicare from an Advantage plan.

The best time to buy a Medigap policy is when you first sign up for Medicare Part B. At that time, you have a "guaranteed issue" window, which forbids Medigap plans from rejecting you because of a pre-existing condition.  (Connecticut, Maine, Massachusetts and New York provide some level of guarantee to enroll at a later time with pre-existing condition protection, and there are some other exceptions under federal law).

In California, one insurer is offering two of its plans to all comers, declaring a limited "underwriting holiday" that will not take your health into account. 

Still, switching to Medigap will mean higher upfront premium costs. Medigap policies are priced according to your age; for those switching into a Medigap G plan in San Diego, the annual cost will range from roughly $2,500 at age 70 to $4,200 at age 80, according to the SHIP.

Some patients are open to switching healthcare providers, Exdell said. But even then, she notes, they face the challenge of navigating a crowded Advantage market with more than 90 plan offerings next year.

"It's a very confusing landscape of options."

https://www.marketscreener.com/business-leaders/MARK-MILLER-19618/news/Column-California-healthcare-provider-s-move-shows-pitfalls-of-Medicare-Advantage-45223312/

Omnicell: Results; Updates Fiscal Year 2023 Guidance; Reduction in Force

 Randall Lipps, chairman, president, chief executive officer, and founder of Omnicell, said, “The team delivered strong cost management and operational discipline this quarter. However, I am disappointed with the weakness in demand that we are seeing and accordingly, we have updated our near-term outlook. We are taking actions to manage the business that are intended to reduce our cost structure and to better align with our anticipated top line performance heading into 2024, while also positioning the Company to continue investing in our innovation agenda. We have taken steps to strengthen our leadership team and we have already begun to reduce discretionary expenses. We remain encouraged that hospitals, health systems, and retail pharmacies continue to rely on Omnicell to help them improve patient and health system outcomes — especially during this dynamic time in the industry. The need for the healthcare industry to automate, optimize, and modernize is more important than ever and we believe Omnicell is well positioned to deliver value to all of our stakeholders over the long-term.”

https://www.businesswire.com/news/home/20231102376671/en/

Hunter Biden says his addiction used as 'disinformation' against father

 Hunter Biden on Thursday said his history of substance abuse has become fodder for a disinformation campaign against President Joe Biden ahead of his father's re-election bid.

Hunter Biden made the statement in an op-ed article for USA Today, rare public remarks on a political and legal controversy expected to feature prominently in the 2024 election.

"My struggles and my mistakes have been fodder for a vile and sustained disinformation campaign against him, and an all-out annihilation of my reputation through high-pitched but fruitless congressional investigations and, more recently, criminal charges for possessing an unloaded gun for 11 days five years ago - charges that appear to be the first-ever of their kind brought in the history of Delaware," he wrote.

Hunter Biden, 53, was charged in September with three counts related to lying on a federal form to acquire a handgun in 2018 and for being an illegal drug user in possession of the gun. He pleaded not guilty.

Republicans have accused Hunter Biden, who has worked as a lobbyist, lawyer, investment banker and artist, of wrongdoing relating to his business activities in Ukraine and China and have made him a focus of a congressional impeachment inquiry of Joe Biden. Republicans allege Biden and his family profited from policies he pursued as vice president during former President Barack Obama's administration between 2009 and 2017. Separately, they also allege the Justice Department interfered with the criminal investigation of Hunter Biden.

They have not found any evidence of misconduct by the senior Biden. Congressional hearings so far have included personal emails and photos of Hunter's personal life and addiction history, much of them allegedly culled from a laptop owned by the president's son.

"I am not a victim," Hunter wrote, citing the privilege and opportunities he has had in life. "What troubles me is the demonization of addiction, of human frailty, using me as its avatar and the devastating consequences it has for the millions struggling with addiction."

The gun case marks the first-ever criminal prosecution of a sitting U.S. president's child, an unwanted backdrop for the president's re-election campaign.

U.S. Special Counsel David Weiss, who is prosecuting the gun case, has been conducting a wide-ranging investigation of Hunter Biden to review whether he violated federal tax and gun laws.

The Biden campaign did not immediately respond to a request for comment. Campaign aides have previously said that Hunter Biden's statements are not coordinated with the president's political aides.

Biden's likely 2024 Republican rival, Donald Trump, faces four upcoming criminal trials of his own, two of which are tied to his attempts to overturn his 2020 election loss to Biden, which he continues to falsely claim is the result of fraud.

Hunter Biden has never held a position in the White House or on his father's campaign. The president has said he has not discussed foreign business dealings with his son and has said his Justice Department would have independence in any investigation of a member of his family.

https://www.marketscreener.com/news/latest/Hunter-Biden-says-his-addiction-used-as-disinformation-against-father-45230307/

Alabama Supreme Court allows first US execution by nitrogen gas to proceed

 The Supreme Court of Alabama has authorized state officials to proceed with what would be the first execution of a prisoner in the U.S. using asphyxiation by nitrogen gas.

In August, Alabama Attorney General Steve Marshall, a Republican, asked the court to allow the state to proceed with gassing Kenneth Smith, who was convicted of murder in 1996, using a face mask connected to a cylinder of nitrogen intended to deprive him of oxygen.

Smith, 58, is one of only two people alive in the U.S. to have survived an execution attempt after Alabama botched his previously scheduled execution by lethal injection in November when multiple attempts to insert an intravenous line into a vein failed.

Smith's lawyers have said the untested gassing protocol may violate the U.S. Constitution's ban on "cruel and unusual punishments," and have argued a second attempt to execute him by any method is unconstitutional. They also told the court that Smith had not yet exhausted his appeals.

In a brief order issued on Wednesday, the court, whose justices are all Republicans, said Alabama Governor Kay Ivey, a Republican, must set a date for the state's Department of Corrections to execute Smith. Two justices dissented from the order and one recused.

A spokesperson for Ivey said her office had not yet determined a date. A spokesperson for the Department of Corrections said the department is "prepared to carry out the orders of the court."

Smith was one of two men convicted in the 1988 murder-for-hire slaying of Elizabeth Sennett in Alabama's Colbert County.

"Elizabeth Sennett's family has waited an unconscionable 35 years to see justice served," Alabama Attorney General Steve Marshall, a Republican, said in a statement. "Though the wait has been far too long, I am grateful that our talented capital litigators have nearly gotten this case to the finish line."

Most U.S. executions are carried out using lethal doses of a barbiturate, but some states have struggled to obtain the drugs because of a European Union law banning pharmaceutical companies from selling drugs that can be used in executions to prisons, forcing them to contemplate other methods.

Oklahoma and Mississippi have also approved nitrogen asphyxiation executions, but have yet to try the method.

The state earlier released a heavily redacted version of the new gassing protocol, which was first authorized by state lawmakers in 2018.

Death penalty experts say it does not make clear how executioners will ensure no oxygen seeps into the mask they intend to put on Smith's face for at least 15 minutes, nor enough information about how the state will mitigate the danger to execution officials and others of using an invisible, odorless gas inside the death chamber.

Robert Grass, a lawyer for Smith, said in a statement that "we remain hopeful that those who review this case will see that a second attempt to execute Mr. Smith - this time with an experimental, never-before-used method and with a protocol that has never been fully disclosed to him or his counsel - is unwarranted and unjust."

https://www.marketscreener.com/news/latest/Alabama-Supreme-Court-allows-first-US-execution-by-nitrogen-gas-to-proceed-45230298/

Hezbollah Escalates Rocket Attacks Amid Reports Russia Could Supply Anti-Air System

 Since the start of the Gaza war in the wake of the Oct.7 Hamas terror raids, Israel's northern border has suffered almost daily rocket attacks, mainly from Hezbollah out of south Lebanon. However, the conflict there has been by and large "contained" thus far, despite limited daily exchanges of fire. 

There has yet to be the kind of all-out Hezbollah assault that many feared. But Thursday did see one of the biggest rocket volleys yet, with Hezbollah's Al-Manar TV station confirming that 25 rockets and mortars were fired in a simultaneous attack on northern Israel. This reportedly included attacks on some 19 separate Israeli positions.

Israel's military subsequently confirmed there were a "number of launches" out of Lebanon, and said in response it struck "a series of Hezbollah terrorist targets in Lebanon." According to to AFP, Israeli forces have hit Lebanon's Hezbollah with a "broad assault".

Al Jazeera correspondent Ali Hashem has noted that "the border fighting appeared to be heating up before the head of Hezbollah, Hassan Nasrallah, is meant to give his first address since the fighting began." Nasrallah's highly anticipated speech is set for Friday.

Hamas units also appear to be operating out of Lebanon, with its Al-Qassam brigades at the same time announcing it has shelled Israel's Kiryat Shmona with a dozen rockets.

Some of the Hezbollah and Hamas missiles have made direct impacts on Israeli communities...

As for Nasrallah's upcoming major speech, he's certainly expected to voice support for Gaza's struggle - but the true wild card remains whether or not he'll declare a major escalation in Hezbollah's attacks. The West sees Hezbollah as a puppet controlled from Tehran.

Regional war correspondent Elijah Magnier has said dozens of drones were also used in Hezbollah's Thursday attack:

Meanwhile, also on Thursday The Wall Street Journal published an alarming new report highlighting potential Russia-Hezbollah military cooperation. The two sides have already for years been in some degree of coordination in Syria while assisting the Assad government against foreign-backed jihadists. 

But now Hezbollah could receive an advanced Russian anti-air system:

The U.S. has intelligence that the Wagner Group, the Russian paramilitary group, may provide an air defense system to Hezbollah, the Lebanese militia, U.S. officials say.

The system in question is the SA-22, which uses antiaircraft missiles and air defense guns, to intercept aircraft.

One U.S. official said that Washington hasn’t confirmed that the system has been sent. But it is monitoring discussions involving Wagner and Hezbollah and that the potential delivery is a major concern.

Russian anti-air system, file image

US officials have been floating evidence-free claims of late that Russia has been behind the scenes stoking the Gaza conflict, and is sowing regional instability. This new WSJ report has been issued within that context. Over the last months, Wagner Group has come under the direct control of Russian state authorities, following the death of the mercenary firm's founder and leader Yevgeny Prigozhin.

https://www.zerohedge.com/geopolitical/hezbollah-escalates-rocket-attacks-amid-reports-russia-could-supply-anti-air-system