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Monday, October 24, 2022

Medtronic to spin off two businesses to streamline portfolio

 Medtronic Plc said on Monday it would spin off its patient monitoring and respiratory interventions businesses into a new company, as it seeks to have a more streamlined portfolio and faster revenue growth.

The separation, expected to be completed in the next 12 to 18 months, will also help the company to unlock value from the two divested businesses, Medtronic said.

The patient monitoring technology portfolio includes Nellcor pulse oximetry and BIS brain monitoring, while the respiratory interventions business comprises ventilators and breathing systems.

The two businesses generated about $2.2 billion in the fiscal year ended April 29 and has more than 8,000 employees globally.

Medtronic, the world's largest standalone medical device maker, has been restructuring its business over the last few years. In 2018, the company announced a restructuring plan expected to help them save $500 million to $700 million annually over five years.

U.S. companies such as Johnson & Johnson, General Electric and 3M Co have been breaking up their businesses amid a growing consensus they perform best with streamlined focus, along with increasing pressure from activist investors to boost shareholder returns.

Medtronic, like many medical device makers, has been facing supply chain shortages and rising costs, exacerbated by the Ukraine conflict and strict COVID-19 lockdowns in China.

https://finance.yahoo.com/news/2-medtronic-spin-off-two-120351914.html

Sunday, October 23, 2022

Behind the scenes during a hospital ransomware attack

 The healthcare industry is under attack. One of the nation's largest health systems, Chicago-based CommonSpirit Health, has been dealing with a ransomware incident that has led to EHR outages and canceled appointments at its hospitals around the nation. Some facilities are just now starting to get their systems back online.

While the hospital chain has released few specifics about the attack that began in early October, cybersecurity experts told Becker's what goes on behind the scenes at one of these events.

Hackers may have access to a company's systems weeks or months before it knows it's been breached, these experts say. The organizations either discover the attack themselves via suspicious activity, or are notified in not-so-subtle ways.

"You receive that deadly scary warning slide that comes up and says you're under a ransomware attack and your data is now held hostage and access to that data is not possible," said Vikki Kolbe, a cybersecurity advisor based in the Boston area. "Or you don't even get a message but one day come in as a privileged user and try to go about your business and can't pull up your data."

But that doesn't mean your entire system will be affected. At CommonSpirit, which operates more than 140 hospitals, some facilities went unscathed from the incident. That's likely because of "the nature of their network architecture and how they share the use of systems across their organization," said Jon Moore, chief risk officer and senior vice president of consulting services for cybersecurity firm Clearwater.

Hackers often get in through relatively simple ways, like phishing emails. These breaches used to be called malware, but are now referred to as ransomware because money is demanded, in the form of untraceable cryptocurrency. Healthcare organizations are now stocking up on the digital currency just in case, said Patrick Angel, a cybersecurity consultant based in Dallas.

The hackers might also "ping" a public-facing or visible server to find out whether it's using an outdated operating system or has unpatched vulnerabilities, Mr. Angel said.

"The older the physical server, the older their operating system and therefore the more likely it has very few if any security features available," he said. "Healthcare is one of the industries notorious for having some of the oldest technology around."

The hackers may sit quietly on the network for months, seeing how many systems or how much data they can access, a technique referred to as "mining," Mr. Angel said.

The cyberattackers often encrypt the data so organizations can't access it, and regularly lock up the companies' backup databases as well. The hackers also sometimes steal the data then threaten to release it publicly unless the ransom is paid.

While the FBI has advised organizations not to pay the cyber ransoms — and it's technically illegal if it involves a sanctioned individual or country — anywhere from 30 percent to 80 percent of companies end up forking over the money, estimates show. The businesses might conclude it's the quickest — and cheapest — way to get the data back and prevent any further breaches.

The average payment is $228,125, according to cybersecurity researcher Coveware's analysis of 2022 second quarter data. Last year, insurer CNA Financial Corp. reportedly paid $40 million to stop an attack, according to Bloomberg.

Organizations typically have cybersecurity insurance, but the quality depends on whether they can withstand "white hat" hackers hired by the insurers, Ms. Kolbe said. There are also now companies and experts that act as go-betweens between ransomware groups and the hacked businesses.

The average downtime caused by the attacks is 24 days, according to Coveware. CommonSpirit's IT issues, which are still ongoing, started being reported Oct. 3.

Some of these events never become public. One health system chief information security officer declined to comment to Becker's because doing so would be an acknowledgement that one admits to a ransomware attack.

However, more than 90 percent of ransomware events are avoidable, a 2019 Gartner report found. "Following the simple basics of IT hygiene is very valuable," Mr. Angel said. That includes "hardening," patching, deleting inactive or unused accounts, regularly backing up data, inventorying devices and data, and having data classification standards. 

The acronym for incident response is PICERL — or preparation, identification, containment, eradication, recovery, lessons learned — Mr. Moore of Clearwater said.

"Preparation comes before the incident," he said. "Once the organization identifies that they have an incident, they will move to try to contain the attack. This might include taking services offline to prevent further spread. Next, they will try to eradicate any malicious software or alterations that the attacker may have made. Finally, they will try to recover their systems and collect lessons learned."

Poland Nears Picking Westinghouse for First Nuclear Power Plant

 Poland is close to choosing Westinghouse Electric Co. to help it build its first nuclear power plant as the European Union’s largest eastern economy rushes to replace its aging coal-fired units.

Polish Deputy Prime Minister Jacek Sasin and Climate Minister Anna Moskwa announcement their preferred option after meeting with US Energy Secretary Jennifer Granholm over the weekend. Westinghouse is competing with Korea Hydro & Nuclear Power Co. and Electricite de France SA for the deal.

https://www.bloomberg.com/news/articles/2022-10-23/poland-nears-picking-westinghouse-for-first-nuclear-power-plant

NY Judge Declares 'Vote By Mail' Law Unconstitutional

The way New York counts ballots was thrown into chaos on Friday after a judge ruled that several of the state's recent voting reforms are unconstitutional.

 State Supreme Court Justice Dianne Freestone sided with Republicans in a lawsuit brought in late September, which argued against a law which allows people to vote absentee if they fear contracting a disease like Covid-19. Freestone also ruled that the new process for "canvassing," or ensuring that absentee ballots are inspected and prepared for counting - violates candidates' rights in several ways, including by making it more difficult to raise a legal challenge when there are questions over a ballot's validity.

"The framers of the Constitution did not intend to grant (and did not grant) the Legislature carte blanche to enact legislation over absentee voting," she wrote.

That said, Friday's 28-page ruling fell just short of invalidating hundreds of thousands of absentee ballots already issued to New York voters, which the Republicans asked the judge to do.

For now, the ruling means local election officials will have to soon pause the inspection of absentee ballots, which were being processed on a rolling basis prior to Election Day for the first time this year. The Democrat-led state Legislature approved the new process in a 2021 law meant to expedite the state’s notoriously slow procedures for counting mail-in ballots.

It also means the more than 427,000 New York voters — including more than 187,000 in New York City — who have already requested and received their absentee ballots will still be able to cast their ballots for the Nov. 8 election, regardless of whether they elected to receive mail-in ballots due to fears of spreading illness. Currently, 108,000 New Yorkers have completed and returned their absentee ballots. -Gothamist

Democratic official immediately responded with a notice that they would appeal the decision.

According to Freestone, the Democrat-controlled Legislature "appears poised to continue the expanded absentee voting provisions of New York State Election Law … in an Orwellian perpetual state of health emergency and cloaked in the veneer of ‘voter enfranchisement.'"

The ruling was a blow to the State Board of Elections, with Freestone arguing that there are "uncounted reasons for this Court to second-guess the wisdom of the Legislature."

The decision could hurt Gov. Kathy Huchul (D) who has been losing ground to GOP challenger Lee Zeldin in recent polls.

"The (state) constitution has been on our side and we will continue to fight to uphold the will of the voters and to ensure honest elections in New York," said plaintiff Nick Langworthy, the state GOP Chairman.

"Just like their illegal Hochulmander and their non-citizen voting scheme, Democrats’ attempt to rig our elections was slapped down by the courts," he continued, adding "When I took over as chairman of the New York GOP, I promised to usher in a new, fighting era that took on Democrats’ brazen lawlessness and this victory is another win for election integrity."

Another plaintiff, Conservative Party Chairman Gerald Kassar, said, “This decision helps uphold the integrity of the electoral process, a major victory for New York voters and the rule of law.”

“Absentee-ballot voters have had the right to amend their votes on Election Day for decades, and cynical attempts by Gov. Hochul and the Democrat Party to strip them of those rights were wrong,” he added.

Last year, state voters rejected a proposed constitutional amendment that would have allowed no-excuse absentee voting in New York.

But lawmakers subsequently enacted a measure that allowed people to vote by mail if they feared catching COVID-19 by voting in person. That expansion of absentee voting is set to expire at the end of this year. -NY Post

On Friday, a BOE spokesperson said "Our office is still reviewing the ruling and its impact on the upcoming election."

https://www.zerohedge.com/political/ny-judge-rules-vote-mail-law-unconstitutional

2 Dead With Monkeypox In NYC As Officials Rename 'Stigmatizing' Disease

 New York City announced two monkeypox-linked deaths on Friday, the first fatalities connected to the disease in the five boroughs, NBC New York reports. Aside from reporting that the individuals were " immunocompromised" and had "underlying health conditions," few details were made public, as officials instead offered condolences in a brief statement.

"We are deeply saddened by the two reported deaths and our hearts go out to the individuals' loved ones and community. Every effort will be made to prevent additional suffering from this virus through continued community engagement, information-sharing, and vaccination," officials said in the statement.

In total, there have now been four monkeypox-linked deaths in the US since the outbreak began, with the first fatality reported in California in September.

As of Oct. 17, the city has recorded at least 3,695 known cases of the virus. Since reaching its peak at the end of July, the outbreak of cases in New York City has dropped significantly, down to single-digit daily numbers by the beginning of this month.

To date, more than 143,000 first and second doses of the monkeypox vaccine have been administered. -NBC NY

Name change

NYC Health Department officials also debuted a new name for monkeypox this week, claiming that the term was 'stigmatizing' - though we would note that it only seems to be left-leaning politicians making this claim.

The new name? MPV

"The previous name is an inaccurate and stigmatizing label for a virus that is primarily affecting a community that has already suffered a long history of bigotry," said the health department, providing no examples. "Stigma is a shadow affliction that can follow viruses and drive people away from care, even when the illness itself is treatable," the city continued.

"The Department requested the World Health Organization change the name, and continues to urge global health authorities to make this modification universal."

"However, the equity considerations are too great to wait any longer," the health department added, Just the News reports.

https://www.zerohedge.com/medical/2-dead-monkeypox-nyc-city-renames-stigmatizing-disease

Gene mutations in tumors impact radiation sensitivity

 A new Northwestern Medicine study identifies common and rare gene mutations that impact radiation resistance and sensitivity, an important step toward providing more individualized and effective radiotherapy for patients with cancer.

Radiotherapy continues to be delivered using generic schedules and doses, unlike newer targeted drug therapy that are guided by the genomics of an individual's cancer.

"The lack of incorporation of genetic data into radiation treatment is a significant unmet clinical need," said corresponding author Dr. Mohamed Abazeed, associate professor of Radiation Oncology at Northwestern University Feinberg School of Medicine and a Northwestern Medicine radiation oncologist.

"This information ultimately will allow us to better calibrate the dose of radiation for patients in the clinic," Abazeed said. "We can give higher doses to more resistant tumors based on their genetic mutations and a lower dose to the more sensitive cancers, allowing us to both improve treatment efficacy and reduce toxicity. The findings hasten a new paradigm in the field of radiation therapy."

The study was published recently in Clinical Cancer Research.

Studying tumors from 27 different types of cancer, investigators profiled 92 genes with 400 unique mutations and determined the impact of these genes on radiation response.

They developed a computational algorithm that nominated mutations in genes that were likely to affect sensitivity to radiation. Scientists tested these mutations by placing them in several human cells and assessed their impact using high-volume arrayed phenotypic profiling.

Cancer genomics spurred 'silver bullet' drugs; radiotherapy is more complex

"Cancer genomics over the last decade has revolutionized how we treat cancer patients from a drug perspective," said Abazeed, also co-leader of the lung cancer program at Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "If you find the right mutation in a patient's tumor, there are now a host of drugs that can selectively target that mutation and, therefore, that tumor."

"But radiation therapy hasn't been able to take advantage of this now readily available genetic information, because the relationship between the cancer genome and our therapy is more complex. There are many genes that regulate the response to radiation in human tumors. It requires large-scale projects like ours to begin to tease out this complexity and identify gene targets that are clinically actionable."

Approaching the clinic

Abazeed and colleagues have tested different dosing of radiation therapy based on the mutation in "patient avatars," human tumors grown directly in mice.

"Our strategies appear to work in a subset of the targets we identified," Abazeed said. The next step will be a clinical trial testing different radiation doses or combinations of radiation with other drugs based on the genetic alterations of individual tumors.

Can we use this information to protect humans from environmental radiation?

The findings also reveal important insights into the interactions between the human genome and radiation as it relates to environmental radiation exposures.

"We are all exposed to relatively low background radiation levels via the ground, air, some building materials and our food," Abazeed said. "Astronauts and future space travelers can be exposed to considerable cosmic radiation. There is also the possibility of incidental radiation exposures via a major nuclear accident or war.

"Understanding the interactions between our genes and radiation exposure is fundamental to both our evolution and survival as a species."

Abazeed and his team are investigating how to alter gene activity to provide greater resistance to radiation as a person is exposed to environmental radiation and reverse these interventions later to prevent unforeseen impacts on human health, including the concern for the development of cancer.

"There are potentially ways you can give someone a drug for a short period of time to activate a gene that confers resistance to radiation and then remove the drug and return gene activity back to baseline," he said.

Other Northwestern authors include Priyanka Gopal, Titas Bera, Trung Hoang and Alexandru Buhimschi.

The research was supported by grants R37CA222294 and P30CA060553 from the National Cancer Institute of the National Institutes of Health.


Story Source:

Materials provided by Northwestern UniversityNote: Content may be edited for style and length.


Journal Reference:

  1. Priyanka Gopal, Brian D. Yard, Aaron Petty, Jessica C. Lal, Titas K. Bera, Trung Q. Hoang, Alexandru B. Buhimschi, Mohamed E. Abazeed. The mutational landscape of cancer’s vulnerability to ionizing radiationClinical Cancer Research, 2022; DOI: 10.1158/1078-0432.CCR-22-1914

Medicare may cap patients’ spending on drugs. But there’s no such limit for hospital or doctor bills

 By 2025, people on Medicare who take expensive medications will feel significant financial relief: They will not have to pay more than $2,000 in a year for all of their drugs.

But the 35 million people who are enrolled in the traditional Medicare program still won’t have that same relief anytime soon for their hospital, outpatient, home health, and nursing home care, leaving them exposed to potentially unlimited costs if they become seriously ill and don’t have supplemental coverage.

“Many people don’t know that traditional Medicare does not have a cap on catastrophic out-of-pocket expenses, because most insurance does,” said Cristina Boccuti, director of health policy at research firm West Health. “People don’t realize it until they enroll in Medicare.”

The issue is especially relevant as Medicare’s annual enrollment is underway, ending Dec. 7. At least 1 in 5 people who choose Medicare Advantage — the alternative to traditional Medicare that is operated by health insurance companies — say they choose it because of the out-of-pocket limits that insurers offer, according to a new survey from the Commonwealth Fund.

Adding an out-of-pocket maximum to the main Medicare program would cost taxpayers money, like it will for drug costs. A vast majority of Medicare patients also wouldn’t hit that cap — roughly 88% don’t spend $5,000 out of their pockets in a year, according to recent estimates from the Urban Institute. But Medicare policy experts say there’s momentum to establish that kind of cap for all services, in part to level the playing field with Medicare Advantage, and most importantly, to give millions of seniors and people with disabilities peace of mind if their health takes a turn.

“There’s the really intangible feeling of financial security that people get from having an out-of-pocket cap even if they’re not going to reach the cap, and that’s an important thing to not overlook,” said Gretchen Jacobson, vice president of Medicare at the Commonwealth Fund.

Nearly all commercial health plans have an annual out-of-pocket maximum, meaning the insurance company or employer covers the entire tab for medical care after someone pays the designated maximum amount. Medicare used to have a cap more than 30 years ago, but it was short-lived. Congress passed a law in 1988 to cap Medicare’s deductibles and copays for hospital and physician care. Lawmakers repealed the law less than a year later after facing backlash from the public.

Many seniors did not understand what was included in the new law, polling at the time showed. However, they knew it meant higher taxes for them. There was a maximum tax liability, so no adult would pay more than $800 in extra annual taxes — but for the wealthy and well-insured, it was a step too far, even if it meant some financial protection for the poorest and sickest patients.

“Many elderly resented the idea of paying additional taxes to finance the new coverage,” researchers wrote in Health Affairs in 1990. “Resentment appeared to be highest among people who already had comprehensive health insurance coverage from a former employer. Not only did they bear the brunt of the financing, but the benefits of the new legislation added little to their existing coverage.”

Congress hasn’t substantively touched the issue since then, so the gap in coverage still exists. Many people in traditional Medicare bridge that gap through a few primary options: retiree coverage if it’s offered by their employer, simultaneously qualifying for Medicaid, or by buying Medigap plans, which limit copays and deductibles but can come with expensive monthly premiums.

It’s worth noting people who first choose a Medicare Advantage plan but later decide to go to traditional Medicare could get locked out of the Medigap market, depending on where they live, because Medigap plans can deny coverage based on pre-existing conditions.

But as the Commonwealth Fund survey and federal enrollment data show, millions of people who don’t have feasible or affordable options for extra coverage have gravitated toward Medicare Advantage, which by law has to limit out-of-pocket costs. Patients who choose those plans are foregoing traditional Medicare’s national network of doctors, hospitals, and other providers in exchange for that security blanket. For this year, the average maximum out-of-pocket in Medicare Advantage plans is around $5,000, and it cannot exceed $7,550 for in-network care, according to the Kaiser Family Foundation.

“For better or for worse, Medicare Advantage has been a vehicle for the government to increase benefits to Medicare beneficiaries without needing legislative changes by Congress,” said Susan Dentzer, CEO of America’s Physicians Groups, an industry-funded group that supports Medicare Advantage.

Creating an out-of-pocket cap for all services in Medicare that is similar to the one in Medicare Advantage would cost billions of dollars because taxpayers would be covering the lion’s share of those catastrophic events instead of patients. A calculator created by West Health estimates a $5,000 limit would increase Medicare spending by $10 billion in 2023.

However, some proposals suggest adding an out-of-pocket max to Medicare could save the government and taxpayers money — when paired with other changes that shift spending away from Medicare. A $7,000 max combined with a policy that bars Medigap plans from covering certain amounts of a person’s deductible and coinsurance could save the government more than $14 billion per year by 2028, according to a Congressional Budget Office report from 2020.

Health insurers aren’t enthusiastic about adding a maximum out-of-pocket to traditional Medicare, which would make the program more appealing and as a result could lead to people dropping their Medicare Advantage and Medigap plans. STAT reached out to the largest insurance lobbying groups — America’s Health Insurance Plans, Better Medicare Alliance, Alliance of Community Health Plans, and AARP — and none offered a full-throated endorsement of capping costs in traditional Medicare.

AHIP released a report last month that said federal spending would be higher in traditional Medicare if it had out-of-pocket limits like Medicare Advantage — a hypothetical the group used to justify the higher payments that Medicare Advantage insurers receive. So would the group support adding a cap to traditional Medicare to compete with Medicare Advantage? Maybe, but only if the government raised payments to insurers even more.

“Should Congress consider enhancing original Medicare’s basic benefits, the existing structure to costs must be included in MA benchmarks to be consistent with the payment structure under the MA program and to be fair to Americans who choose MA,” AHIP said in a statement.

The Better Medicare Alliance did not explicitly support a maximum out-of-pocket for traditional Medicare beneficiaries, saying in a statement that it wants seniors to have financial protection, but “an out-of-pocket cap will not itself replicate the coordinated, whole-person care found in Medicare Advantage.”

The Alliance of Community Health Plans did not offer an official stance on a maximum out-of-pocket in traditional Medicare, and said it believes “the best path forward is Medicare Advantage and [we] are advocating for a next generation of the program, not the volume-based care in traditional Medicare.”

AARP, which generates revenue from the sale of Medigap plans and has a financial relationship with UnitedHealth Group, the largest Medicare Advantage insurer in the country, did not comment.

Congress isn’t any closer to addressing this gap, but that doesn’t make it any less of a concern for the 17% of patients in the traditional Medicare program — roughly 5 million to 6 million people — who have no extra coverage whatsoever.

“There are many Americans who can’t afford supplemental coverage or don’t want to be in a [Medicare Advantage] health plan, and want to stay in traditional Medicare,” Boccuti of West Health said. “They’re really exposed to a year of high out-of-pocket costs if they have a serious health event.”

https://www.statnews.com/2022/10/21/medicare-will-cap-patients-drug-spending-no-limit-for-hospital-doctor-bills/