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/

Covid Gamma Variant Rises in Washington State

 On top of a historic heat wave, the Pacific Northwest has been hit with a rise in COVID-19 cases caused by the Alpha, Delta, and Gamma variants. And while much of the world is focused on Delta, or B.1.617.2, government officials in Washington state are particularly wary of Gamma (P.1).

Washington state's leading COVID-19 strain remains Alpha (B.1.1.7), first detected in the U.K. But according to recent data released by the state's Department of Health (DOH), cases caused by Gamma reached 16.3% in mid-June -- a decrease from a high of 20.6% in May. Delta cases increased by more than 10% from May to June, now making up 17.6% of infections in the state -- all while Alpha cases continue to slowly dwindle.

Although the Delta variant has eclipsed Gamma cases in Washington in recent weeks, state epidemiologist Scott Lindquist, MD, MPH, has continued to express his worries about Gamma's detrimental impact.

"Our Delta variant is not as aggressive, it's not causing as many hospitalizations or deaths as would be predicted, but the P.1 tends to be causing more hospitalizations and deaths," Lindquist said in a DOH briefing about the state's June 30 reopening.

The Gamma variant was, in fact, associated with the highest number of hospitalizations and deaths in comparison to any other strains of COVID-19, including Alpha and Delta, according to the DOH report.

Notably, Gamma was detected in 17% of breakthrough infections after vaccination, making it second overall -- after Alpha -- in vaccine breakthroughs.

Despite these data, Lindquist assured that "all the vaccines we have in Washington state still show effectiveness for these variants," as Washington's DOH continues its vaccination campaign. "It's much more of a risk to be unvaccinated in this state right now than it is any concern for the vaccine not working against these variants," he said.

Gamma was first identified among travelers from Brazil at the beginning of January during a routine screening at an airport in Japan. When Gamma became the dominant strain of SARS-CoV-2 in Brazil not long after, both the World Health Organization and the CDC designated Gamma as a variant of concern. Now, it has been identified in at least 37 countries and 31 U.S states.

After Manaus, the capital of Brazil's Amazonas region, was struck with a wave of COVID cases in the spring of 2020, certain studies suggested that the city may have reached herd immunity. However, the Gamma variant caused a resurgence of SARS-CoV-2 infections in Manaus in January of this year.

A study of Manaus's COVID resurgence found that Gamma could be nearly twofold more transmissible than other variants from the same lineage. Data from Manaus indicated that "P.1-infected adult individuals are more infectious than those harboring non-P.1 viruses," wrote Felipe Gomes Naveca, of the Leonidas and Maria Deane Institute's Laboratory of Ecology of Communicable Diseases, and colleagues.

Gamma closely resembles the lineage of Beta (B.1.351), which was first detected in South Africa and is now a variant of concern. Because Beta and Gamma share some of the same mutations on the coronavirus spike protein, they're both capable of overcoming the immunity that individuals may have developed after being infected by other strains.

Like Beta, Gamma contains the N501Y and K417T mutations, both of which give the virus a tighter grasp on human cells. It also carries E484K, a mutation known to help the virus evade certain types of antibodies. Vaccines, therefore, may offer less protection against the Gamma variant than others.

https://www.medpagetoday.com/special-reports/exclusives/93415

Catalyst, Zogenix, Rigel and Pfizer kick off pharma's July price hikes

 Pharma companies haven’t shied away from raising prices even in the midst of a global pandemic. And now that the world is slowly beginning to creep out of the crisis, this July doesn’t appear to be any different. 

To kick off the month, a slate of drugmakers have already raised prices on 32 medicines by an average of 3.6%, GoodRx reports. It’s still early in the counting, and it’s likely that pharma is just getting started if previous trends are any indication.

The early start has consisted mostly of smaller drugmakers, in many cases dealing with rare disorders, such as Zogenix, Rigel Pharmaceuticals, Recordati Rare Diseases, Catalyst Pharmaceuticals, Azurity Pharmaceuticals and others. 

Zogenix’s 9.5% increase for its rare childhood epilepsy drug Fintepla marks the largest hike so far. Fintepla became Zogenix’s first commercialized product nearly a year ago when it scored an FDA nod to treat seizures associated with Dravet syndrome, entering the market with a $1,278 list price for a 30 mL bottle. 

Then there’s Catalyst’s controversial drug Firdapse for patients with a rare neuromuscular disorder called LEMS. The company faced fierce backlash after launching the treatment at $375,000 per year, even though another company had been giving it away under the FDA's compassionate use. 

Catalyst will increase Firdapse’s list price by 4.5%, GoodRx reports. Meanwhile, Rigel’s first and only FDA-approved drug Tavalisse, used to treat chronic immune thrombocytopenia, will see a 5% increase. 

Some drugs on the list already grew in price earlier this year. For instance, Recordati had raised the price of Isturisa, approved to treat Cushing’s disease, by 9% in January. The company kicked off July with another 5% hike, GoodRx reports. Specialty pharma company TerSera Therapeutics upped its chronic pain drug Prialt another 4% after doing so in January. 

In January, pharma hiked prices by an average of 4.5% on more than 800 drugs, according to GoodRx's tally. Pfizer accounted for a significant portion of them and has already kicked off this round with 1.5% bumps for acute myeloid leukemia drug Mylotarg and acute lymphoblastic leukemia treatment Besponsa. 

The increases come as the industry faces looming uncertainty over drug pricing reform in the U.S. While President Joe Biden has supported changes that would allow Medicare to negotiate prices for high-cost drugs, among other measures, the president left drug pricing provisions out of his American Families Plan. That effectively moved the discussion over to a divided Congress, where pricing reforms have languished for years.

But reform chatter has recently resurfaced after the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm. Some lawmakers are concerned that the treatment, priced at roughly $56,000 per year, could severely inflate Medicare’s spending by billions. 

https://www.fiercepharma.com/pharma/pfizer-zogenix-catalyst-rigel-kick-off-pharma-s-july-price-hikes-report