More than 1/3 of health organizations hit by ransomware last year

 

• More than a third of healthcare organizations were hit by a ransomware attack in 2020 and of those, 65% said the cybercriminals were successful in encrypting their data, a report from cybersecurity company Sophos found.
• The report also found that roughly a third of organizations that had data stolen paid the ransom to recover their information, but on average only 69% of the encrypted data was restored after the ransom was paid.
• The average bill to recover after a ransomware attack was almost $1.3 million, which is among the lowest sum of all industries surveyed in the report.

Ransomware is a type of malware that encrypts a victim's files, rendering them inaccessible to their owner, unless a ransom is paid to decrypt them.

Sophos commissioned independent research company Vanson Bourne to survey 5,400 IT decisionmakers across a range of industries worldwide, including more than 300 small and mid-size organizations from healthcare, early this year.

The report found ransomware was relatively prevalent in the healthcare sector, with 34% of organizations hit by such an attack in the past year. Of those not hit, 41% said they expected an attack in the future, while just 24% said they felt safe from future attacks.

Healthcare actually fared relatively well compared to other sectors. The global average for organizations attacked was 37%, with the retail and education industries experiencing the highest number of ransomware attacks at 44%.

"With healthcare often making headlines for ransomware attacks, it's perhaps a welcome surprise that this sector experiences below average numbers of attacks," the report said. "Their over-representation in the news reports is likely due to healthcare organizations' obligations to make public an attack, where many commercial organizations are able to keep the bad news private."

But despite the lower prevalence of attacks, healthcare is less able to stop ransomware than other sectors, Sophos found. Attackers' success rate in encrypting healthcare data was 65%, compared to the global average of 54%, likely due to the financial and resource challenges in health IT. The teams are commonly understaffed, and have been especially stressed during the coronavirus pandemic.

Additionally, healthcare organizations are among the most likely to pay a ransom to recover their data, likely worried about continuity of care for their patients and a lack of back-ups. Some 34% of respondents whose data was encrypted said they paid to get it back, compared to a cross-sector average of 32%.

However, paying a ransom is no certainty that data will be recovered — one reason why giving into demands for ransom is highly discouraged by the federal government and cybersecurity experts. Organizations that shelled out the ransom on average received just 65% of their data, while another third was left unaccessible.

The average healthcare ransom payment was roughly $131,000, lower than the global average. Healthcare also had the lowest overall cost to recover from a ransomware attack than any other industry, at $1.27 million for issues like downtime, hours lost, device and network cost, ransom and so on. By comparison, the cross-sector average is $1.85 million.

Though healthcare seems to be doing relatively well compared to other industries when it comes to ransomware attacks specifically, the industry faces a number of unique challenges stemming from its outdated infrastructure, including underfunded IT departments and legacy medical devices with little-to-no cybersecurity features. Fewer than half of healthcare organizations met national cybersecurity standards in 2019, even as cyberattacks grow in complexity.

The percentage of organizations across all sectors hit by ransomware in 2020 dropped from 2019, Sophos found. That's a good sign, but may indicate attacker behavior is evolving to smaller-scale, more targeted attacks, which have higher potential for damage.

As a result, the report called on healthcare companies to invest more heavily in cybersecurity moving forward.

https://www.healthcaredive.com/news/more-than-13-of-health-organizations-hit-by-ransomware-last-year-report-f/602329/

Half of ambulance rides could still result in surprise bill: KFF

 

• Slightly more than half of emergency ground ambulance rides resulted in an out-of-network bill, according to a new analysis from the Kaiser Family Foundation.
• In seven states — Washington, California, Florida, Colorado, Texas, Illinois and Wisconsin — more than two-thirds of emergency ambulance rides resulted in out-of-network billing.
• Congress' ban on surprise bills kicks into effect next year, but ambulances are exempt from the legislation, meaning patients will still be on the hook for those pricey, unexpected bills.
• Tamping down on surprise bills, which occur when a patient unknowingly receives care from an out-of-network provider or facility, was one of the hottest health policy discussions in Washington before the coronavirus slammed onto the scene. It's a pervasive issue: Previous research from KFF found that among large group health plan enrollees, one in five emergency room visits and one in six admissions to an in-network hospital led to a surprise medical bill.

In December last year, Congress passed the No Surprises Act, which prohibits surprise out-of-network billing beginning in 2022. The legislation requires plans to apply in-network cost sharing to surprise medical bills and prohibits out-of-network providers from balance billing patients for the unexpected costs.

However, the law doesn't apply to ground ambulances, though it did call for an advisory committee to review options for restricting surprise ambulance bills. Critics said at the time it was a notable oversight, as a large proportion of emergency rides result in surprise bills.

The new KFF analysis adds credence to that perspective. Researchers found ambulances bring on average 3 million privately insured people to an ER each year, and just over half of those rides posed a risk of a surprise bill. Using data from 2018, KFF found 51% of emergency ground ambulance rides and 39% of non-emergency ground ambulance rides included an out-of-network charge.

In the absence of sweeping federal protections, a number of states and local governments have stepped up to try to regulate patient billing, though they can't touch the self-funded employer plans that cover roughly two-thirds of U.S. workers. Many states protect patients from getting a ground ambulance surprise bill if they're covered by fully-insured plans, though many regulations only apply to a subset of ambulance companies, KFF said.

Researchers stressed additional protections are needed, given as many as 1.5 million privately insured patients brought to an ER by an ambulance could be at risk for a surprise bill.

"The regulation and delivery of ground ambulance services could present complexities beyond those involved in preventing other surprise medical bills," the report reads. "Yet, from the perspective of patients, ambulance rides are exactly the kinds of situations where they feel powerless to avoid surprise bills."

https://www.healthcaredive.com/news/half-of-ambulance-rides-could-result-in-surprise-bill-kff-finds/602435/

Nearly half of physician practices owned by hospitals, corporate entities

 

• Nearly 70% of U.S. physicians are now employed by a hospital or a corporate entity, according to the latest report by Avalere for the Physicians Advocacy Institute, a coalition of state doctors' groups. This is the first time the report included ownership by corporate entities outside of just hospitals.
• Hospitals and corporate entities, which include insurers or private equity groups, own nearly half of the physician practices in this country, according to the report released Tuesday that examines the two-year period from 2019 through 2020.  
• This longtime trend was exacerbated during the COVID-19 pandemic, according to the report, which shows 48,400 physicians left private practice during the study period across all regions of the country.   

Independent physicians are becoming increasingly rare in the U.S., which should raise some alarms, according to the Physicians Advocacy Institute.

This latest analysis shows that just three in 10 of the nation's physicians remain independent. More physicians left independent practice after the onset of the pandemic, according to the report. Of the 48,400 that became employed by either a hospital or corporate entity over the two-year period, 22,700, or about 47%, left after the pandemic started.

The advocacy group penned a letter to Congress, urging greater federal scrutiny with a plea for policies "to help protect the physician-patient relationship from undue corporate interference," the Monday letter stated.

"This report shows a startling shift towards the corporatization of healthcare across the U.S., which if left unchecked, may result in an inappropriate incursion into the practice of medicine," the group wrote.

Hospitals have increased their ownership stake in medical practices over the years. In 2018, 44% of physicians were employed by hospitals. By 2021, that figure increased to 49.3%, according to the report.

But it's not just hospitals that are interested in medical groups. Private equity groups and insurers have become increasingly interested in the space.

A recent JAMA report measured how many medical groups, and what kinds of practices, were acquired by private equity over a four-year period from 2013 to 2016. While many questions still need to be answered on private equity's influence on quality and care, researchers said the report was important to assess the scope of the trend.

Insurers are also interested in gobbling up physician groups as they seek to greater control through vertical integration. Recently, Humana acquired the remaining stake of Kindred at Home, the biggest home health provider in the U.S.

https://www.healthcaredive.com/news/nearly-half-of-physician-practices-owned-by-hospitals-corporate-entities/602540/

Rural hospital CEO urges providers 'get ready now' as delta variant outstrips nursing resources

 The delta variant of the novel coronavirus is gaining a frightening foothold in areas of the country with low vaccination rates, spurring the White House to mobilize "surge response teams" to combat the variant that threatens to undo the nation's progress in beating back the pandemic.

About 1,000 counties in the U.S. have vaccination rates below 30%, primarily in the Southeast and Midwest, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Thursday. Walensky warned that communities with low vaccination rates remain vulnerable to the "hyper-transmissible" variant.

In Southwest Missouri, CoxHealth CEO Steve Edwards has been sounding the alarm on Twitter as he sees the variant take hold in his community, causing hospitalizations and cases to rise. The vaccination rates in some of the counties surrounding Springfield are below 30%, according to data from the CDC.

For the first time throughout the entire pandemic, Springfield, Missouri-based CoxHealth has had to divert patients to hospitals in larger metropolitan areas such as Kansas City and St. Louis.

"It's grown so rapidly that it's outstripped our ability to meet the need," Edwards said in an interview on Thursday ahead of the holiday weekend.

The main problem is the six-hospital system does not have enough nurses to respond to the latest spike in hospitalizations and is struggling to find traveling nurses to fill the demand. Right now, CoxHealth has 100 traveling nurses. It needs double that amount, Edwards said.

"We can't find them," he said. "We think that might be because of the seasonality of [traveling nurses], a lot of people worked very hard in the winter months, they put in extra hours, made extra money and now maybe they're home with their kids in the summer."

Many hospitals have been reporting a nursing shortage since late last year, and some have taken to offering steep sign-on bonuses and other measures.

CoxHealth was well prepared for the first surge of COVID-19. It built an entirely new unit of 33 beds in response to the pandemic.

Edwards wants other hospital operators to know that this latest variant seems to take hold much more quickly, even with some level of protection from vaccines.

"It'll turn faster than it did in the fall in terms of case count, so you won't have much time to get ready, so get ready now," Edwards said.

CoxHealth is currently treating more than 100 COVID-19 positive patients. Just a few weeks ago, that number hovered around 14 patients. At its highest point, the system reached 170 COVID-19 patients.

At this time, Edwards said the system is not shutting down electives due to the demands of COVID-19 patients. His hospitals are also full because they're treating more routine patients who put off care last year.

As the holiday weekend approaches, some are fearful that more gatherings could ignite more outbreaks, particularly in areas of low vaccinations rates. Some local governments, including Los Angeles and St. Louis, are urging people to mask up indoors, even if they're already vaccinated, to slow the spread of the variant, coming on top of renewed advice on masking by the World Health Organization.

Also, some parts of the country are experiencing record-high temperatures, putting further strain on hospitals resources.

https://www.healthcaredive.com/news/rural-hospital-ceo-urges-providers-to-get-ready-now-as-delta-variant-outs/602750/

Deaths Drop, but COVID-19 Cases Rise 10% Over Last Week

 After a steady period of decline, the daily average of new COVID-19 cases has started ticking upward, CDC Director Rochelle Walensky, MD, said Thursday at a White House news briefing.

She said the CDC reported 14,875 new COVID cases on Wednesday and that the 7-day average is around 12,600 cases per day. That's a 95% decrease in daily cases from the US peak in early January, she said, but it's a 10% increase over a week ago.

"We continue to see overall low numbers of cases, hospitalizations, and deaths," she said. "However, looking state by state and county by county, communities where people remain unvaccinated are communities that remain vulnerable. This is all true as we monitor the continued spread of the hyper-transmissible Delta variant."

She said about a quarter of sequenced US cases are the Delta variant. It may well become the dominant variant in coming weeks, and more Delta cases are expected to turn up in areas with low vaccination rates, such as the 1000 counties that have a vaccination rate of below 30%.

"As we prepare to celebrate Independence Day, I want to remind those who remain unvaccinated to protect themselves by wearing a mask and avoiding crowds to prevent transmission and illness," Walensky said. "If you have symptoms of COVID-19, please get tested. And, of course, please get vaccinated in one of the many places near you as soon as you can."

Walensky cited encouraging statistics: The 7-day average of hospital admissions related to COVID is about 1822 per day, a drop of 1% from the previous 7-day period. The daily average of COVID deaths is 257 over the last 7 days.

Vaccine hesitancy is still a problem for health officials, despite programs encouraging people to get shots. The United States has not reached President Joe Biden's goal of having 70% of adults partially vaccinated by July 4.

The CDC said that 66.7% of people 18 and over have at least one shot, with 57.7% fully vaccinated. Of all ages in the US, 54.6% have at least one shot and 47% are fully vaccinated.

More than 328 million vaccine doses have been given since the vaccination program started in mid-December, the CDC said.

The United States still has the most COVID-related cases and deaths among all nations — 33.6 million and 605,000, respectively.

https://www.medscape.com/viewarticle/954186

What Drove Gene Editing Stocks Higher This Week

 This has been a monumental week for gene editing pioneer Intellia Therapeutics (NASDAQ:NTLA). This was the last of the three original CRISPR companies to start a clinical trial, but it was well worth the wait. Clear signs that Intellia's revolutionary new way to treat inherited diseases actually works have already pushed the stock 93% higher since markets closed last Friday.

The remarkable news pushed shares of Beam Therapeutics (NASDAQ:BEAM), Editas Medicine (NASDAQ:EDIT), and CRISPR Therapeutics (NASDAQ:CRSP), 42%, 35%, and 10% higher, respectively, before the U.S. markets opened this morning.

Intellia's first new drug candidate to begin clinical trials, NTLA-2001, permanently edits a problematic gene inside the body. The first clinical-stage therapy candidate from CRISPR Therapeutics, called CTX001, alters genes in stem cells after they've been removed from the patient. Editas Medicine's first clinical-stage candidate, EDIT-101, is injected into patients' eyeballs and it's supposed to stay there. Beam Therapeutics still hasn't advanced a new drug candidate in clinical-stage testing.

Intellia's lead candidate is a pair of messenger RNA strands surrounded by a specialized fat bubble or lipid nanoparticle (LNP). Unlike Editas Medicine's candidate, NTLA-2001 can safely travel through the bloodstream to reach the liver.

Going into 2020, safely sending RNA strands through the bloodstream so they can instruct cells to produce therapeutic proteins seemed like a far-off dream. Last year, Moderna and BioNTech showed us that LNP technology had finally advanced to a stage that makes RNA-based drugs a real possibility.

The RNA-based vaccines from BioNTech and Moderna instruct human cells to make a spike protein that helps our immune systems immediately recognize the real virus. Intellia's gene therapy for the treatment of transthyretin amyloidosis with polyneuropathy (ATTR-PN) employs RNA, too, but there's a lot more.

The genetic instructions in NTLA-2001 get liver cells to produce a CRISPR-Cas9 complex that specifically disables the transthyretin gene. This prevents transthyretin from entering the bloodstream where it can fall apart and get jammed up in places it doesn't belong. 

Intellia's revolutionary gene therapy candidate appears to work even better than hoped. A single dosage of just 0.1 milligrams per kilogram of body weight reduced circulating transthyretin by 52% among three ATTR-PN patients in this group. Among patients given 0.3 milligrams, investigators measured an 87% average reduction. 

Alnylam already markets successful therapies for a very limited population of ATTR-PN patients. Intellia's investors are more excited about the successful use of LNP encapsulated mRNA strands to coax cells into producing gene-editing machinery. That's because creating more therapies by swapping transthyretin for different troublesome genes should be relatively simple. 

It was nice to see several gene-editing stocks bound higher in response to Intellia's good news, but they probably shouldn't have. That's because Intellia's miles ahead of its peers.

Beam Therapeutics is working on LNP encapsulated RNA strands to treat glycogen storage disorder and alpha-1 antitrypsin deficiency. Beam's unique approach doesn't create double-stranded breaks in DNA the way NTL-2001 does. This should lead to more precise editing and better outcomes down the road. It's going to be a while before we know for certain. The company hasn't even nominated a candidate that uses LNPs and RNA for advancement into human-stage testing yet.

Editas Medicine's lead candidate is in clinical-stage testing. Instead of mRNA encased in an LNP, EDIT-101 uses a viral vector to deliver DNA that instructs cells in the eye to make gene-editing machinery. At the moment it doesn't look like Editas Medicine or CRISPR Therapeutics have any plans to create gene-editing therapies similar to Intellia.

https://www.fool.com/investing/2021/07/02/heres-what-drove-gene-editing-stocks-higher-this-w/

5 FDA decisions to watch in the third quarter

 The Food and Drug Administration made one of the most controversial decisions in its history early last month, when the agency decided to clear Biogen's Alzheimer's drug despite contradictory evidence from clinical trials.

Few forthcoming actions can match that approval's impact, but the FDA still faces a slate of critical decisions in the months ahead. Looming largest are expected full approvals for Pfizer's and Moderna's coronavirus vaccines, which remain only cleared for emergency use more than six months after their initial authorizations. While the outcome is not in doubt, calls have grown for the FDA to speed its review as news of a standard approval may help convince vaccine hold-outs and skeptics. 

The FDA will also need to decide whether the bar it set with Aduhelm's approval holds for other drugs like it, as Eli Lilly has said it will apply for an accelerated OK of a treatment called donanemab later this year. An approval decision likely wouldn't come until well into 2023, but the FDA first has to agree Lilly's study data are enough to merit a review. 

Important questions on the safety of several new arthritis drugs, a closely watched anemia drug and an unusual diabetes treatment are also set to be decided. Read on for details on all five: 

Full approval of Pfizer's and Moderna's coronavirus vaccines

The two coronavirus vaccines from Pfizer and BioNTech, and Moderna, are the most widely used and powerful tools in the COVID-19 response in the U.S. Since their initial clearances in December, the two shots have accounted for about 96% of the roughly 328 million doses administered to date to Americans. Real-world use has affirmed both to be safe and strongly effective, helping drive down infections, hospitalizations and deaths. 

But six months after their initial clearances, both vaccines are still distributed under emergency use authorization, a regulatory pathway meant to speed critical treatments during a public health crisis, rather than a standard drug approval. 

Transitioning each to full approvals could be important to re-energizing a U.S. vaccination campaign that has slowed considerably since April. Full approvals could help counter persistent vaccine hesitancy and would give employers backing to mandate vaccinations. The urgency to grant them is growing, as the Delta variant is fast becoming the dominant strain in the U.S. Research has shown Delta to be more transmissible and potentially more resistant to immune responses, although full vaccination with Pfizer's and Moderna's shots still appears protective .

Pfizer and BioNTech filed an approval application in May, and Moderna followed in early June. Though the FDA typically takes up to six months to review an application, both developers submitted "rolling" submissions, enabling the agency to review paperwork as it is filed and streamline the process. 

Acceptance of Eli Lilly's Alzheimer's drug application

Any doubts about whether the FDA set a precedent with approval of Biogen's Aduhelm were quickly dispelled by Eli Lilly, which two weeks after the agency's decision declared it would seek approval for its similarly acting drug donanemab. 

The announcement was a reversal from just two months earlier, when a top Lilly R&D executive said the company did not think it had enough evidence to ask for an OK. 

That assessment apparently changed when the FDA surprisingly decided to base its approval of Aduhelm not on the drug's purported clinical benefit, but rather its ability to clear the brain of toxic plaques. Donanemab does that job, too, and data from a small Phase 2 study released earlier this year showed it does so quite well. 

It's unclear whether the FDA confirmed that Lilly's results were sufficient to move forward. But the company was confident enough to announce it would file an approval application later this year. The agency has two months after Lilly submits to decide whether it will accept and start a review. 

Other Alzhiemer's drugs could soon follow donanemab. A report from analysts at Jefferies said Roche will take a similar approach with its drug gantenerumab, although the company would not confirm its plans. 

Warning for arthritis drugs from Pfizer, AbbVie and Lilly

Pfizer's Xeljanz is one of the company's top-selling medicines, widely used for rheumatoid arthritis and three other inflammatory conditions. 

So it was notable news when, in late January, Pfizer said a large safety study found patients taking the drug were more commonly affected by major heart complications and cancer than those who received another type of drug.

The results raised alarm bells, including at the FDA, which has since pushed back decisions to expand approvals for drugs from AbbVie and Eli Lilly that work the same way as Xeljanz. In its announcement of the latest delay, AbbVie said the regulator had cited an ongoing review of data from Pfizer's safety study. 

The concern over side effects linked to the drugs, known collectively as JAK inhibitors, isn't the first safety red flag. All carry the FDA's strictest warning for the risk of serious infection, malignancy and blood clots. 

Analysts expect a new warning label as the most likely outcome of the FDA's review, but other options, including limiting certain drugs to lower doses, could be possible, albeit less likely. 

Several other JAK approval decisions are expected in July and September, meaning more delays might be forthcoming.

The advisory committee meeting on Fibrogen's anemia drug

Much has changed since last year when FibroGen first sought FDA approval of roxadustat, an anemia pill for people with chronic kidney disease that could become the first drug of its kind in the U.S. 

First, the FDA's review of FibroGen's application was delayed from December to March. Then, company executives expressed surprise after the agency revealed plans to consult an advisory committee, pushing a decision back even further and seeding doubt about the drug's prospects.

But the most significant twist came in April, when FibroGen made the stunning disclosure that cardiovascular safety data it had touted in press releases and medical conferences since 2019 — numbers used to claim roxadustat was as good or better than injectable drugs or placebo at reducing heart risk — were misleading. 

FibroGen updated the results, and executives argued there was "no change" in the drug's efficacy data and stressed confidence in its safety. Since then, FibroGen won a key endorsement as Europe's drug regulator recommended approval. But the FDA advisory committee meeting represents the company's stiffest test yet, as FibroGen's data are set to be publicly scrutinized by FDA scientists and outside experts. 

Geoffrey Porges, an analyst at SVB Leerink, wrote recently he expects votes supporting the drug's use in both potential indications — chronic kidney disease patients who are or aren't on dialysis — along with "cautionary language" in the drug's label.

The meeting is set for July 15. The FDA hasn't yet announced a target decision date for FibroGen's drug, though it has set a March 22 deadline to complete a review of a rival treatment from Akebia Therapeutics. 

Approval of Provention Bio's diabetes drug

Friday is a critical date for the future of Provention Bio, a small biotech that took a chance on a diabetes drug with a checkered past. 

Three years ago, Proventin bought rights to a drug called teplizumab that had been shelved by Macrogenics and partner Eli Lilly in 2010 after a trial setback in Type 1 diabetes. Academic studies continued, however, and eventually showed signs teplizumab might delay the disease's onset. 

Provention went public with a pitch to prove that benefit, and sought an approval after results from a Phase 2 study showed a 14-day course delayed insulin-dependent, clinical-stage disease in patients who hadn't yet developed symptoms. If approved, the drug would be the first therapy cleared to prevent the disease, at least temporarily.  

But Provention has had a bumpy ride since then. The FDA found "deficiencies" in its approval application and asked for more data, dimming the drug's approval prospects. And while an advisory committee in May recommended approval of teplizumab, the vote was close. Several panel members were concerned about the severe side effects seen with treatment, and recommended a narrower group of patients be eligible for the drug. 

All of which has injected considerable uncertainty into the FDA's imminent decision, which could result in a delay, rejection, or "unexpected approval," SVB Leerink analyst Thomas Smith recently wrote.  

https://www.biopharmadive.com/news/5-fda-decisions-third-quarter-2021/602786/