Florida Cancer Center to Pay $100 Million for Criminal Conspiracy

Florida Cancer Specialists (FCS) & Research Institute, one of the largest oncology and hematology service providers in the state, has been charged with criminal antitrust conspiracy and will pay a penalty of $100 million.
For nearly 20 years, FCS, headquartered in Fort Myers, had an anticompetitive, “illegal agreement” to divide up cancer treatment services with another provider in Collier, Lee, and Charlotte counties in southwest Florida, says the US Department of Justice (DoJ). The deal allocated chemotherapy treatments to FCS, and radiotherapy to the other, unnamed oncology group.
FCS revenues totaled nearly $1 billion for treatments delivered by way of the illegal deal, said the DoJ.
The arrangement “allowed FCS to operate with minimal competition in Southwest Florida,” from as early as 1999 until at least 2016, according to the DoJ.

“For almost two decades, FCS and its co-conspirators agreed to cheat by limiting treatment options available to cancer patients in order to line their pockets,” said Makan Delrahim, assistant attorney general of the DoJ’s Antitrust Division, in a press statement.
FCS has also agreed to pay the state $20 million to settle a related civil antitrust investigation, the state attorney general announced last week. Notably, the state cited four oncology practices as co-conspirators in its complaint, not just one as in the federal case.
However, FCS will not be barred from participating in (and being reimbursed by) federal healthcare programs, such as clinical trials, which would otherwise be a possibility with a crime of this type.
FCS has approximately 100 offices and more than 200 doctors statewide, and is among the largest oncology and hematology medical practices in Florida, according to the Florida Attorney General’s office.
This is not FCS’s first legal dispute regarding anticompetitive business practice in Florida.
Last year, the company settled with Mid Florida Cancer Centers for an undisclosed amount (but did not admit any wrongdoing) about another market dispute in Florida, according to the Orlando Sentinel.
In that case, Mid Florida Cancer Centers alleged that AdventHealth, an oncology provider and hospital owner, struck an exclusive agreement with Florida Cancer Specialists to “not compete with each other in Volusia and Flagler counties; to create a referral loop that excluded Mid Florida; and to stop giving hospital privileges to new doctors hired by Mid Florida.”

FCS Avoids Paying Another Price

The DoJ ultimately handled the resolution of the case against FCS via a “deferred prosecution agreement.” That avoids a criminal conviction and allows FCS to continue to participate in federal healthcare programs. It also allows patients to continue participating in ongoing, federally funded clinical trials at FCS.

FCS can also continue its involvement with, for example, the Oncology Care Model (OCM), an experimental Medicare payment and services arrangement that financially rewards efficient care. The model is limited to about 200 clinical practices in the United States, including FCS.
Lucio Gordan, MD, president of FCS, said in a reported statement that change has occurred at the organization: “Shortly after learning about this issue, FCS brought on new leaders, materially enhanced its employee training, and bolstered its compliance program.”
FCS has ties to prestigious oncology organizations. It is a recipient of the American Society of Clinical Oncology’s national Clinical Trials Participation Award. “CTPA recipients have shown the dedication and committed the resources to develop high-quality clinical research programs in the community setting,” ASCO President Richard Schilsky has said.
FCS is also one of five “strategic sites” of the Sarah Cannon Research Institute, based in Nashville, Tennessee, which enrolls patients in hundreds of oncology trials, including many immunotherapy studies. FCS states on its website that, in the past 4 years, “the majority of new cancer drugs approved for use in the US were studied in clinical trials with Florida Cancer Specialists participation.”
FCS claims that it delivers “quality and value through patient-centered, coordinated care” and is the only community oncology practice in Florida that is a Blue Distinction Center for Cancer Care, a designation from Florida Blue, a Blue Cross and Blue Shield Association member.
The federal charge against FCS is part of an ongoing investigation into anticompetitive conduct in the oncology industry in Florida, being undertaken by the DoJ’s Antitrust Division and the FBI’s Tampa Field Office.
https://www.medscape.com/viewarticle/929900

Genprex new license agreement expands oncology franchise

Licensed technologies include use of Genprex’s TUSC2 gene therapy combined with immunotherapy drugs, including:

• Pembrolizumab (Merck’s largest selling drug Keytruda®)
• Nivolumab (Bristol-Myers Squibb’s Opdivo®)
• Ipilimumab (Bristol-Myers Squibb’s Yervoy®)

Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that it has entered into a Patent and Technology License Agreement (“License Agreement”) with The University of Texas MD Anderson Cancer Center (“MD Anderson”) in which MD Anderson granted to Genprex an exclusive worldwide license to a portfolio of 16 patent applications and related technology (“Licensed IP”) for the treatment of cancer using Genprex’s lead drug candidate and TUSC2 gene therapy, known as “Oncoprex” or “GEN-001,” in combination with immunotherapies. This is a distinct therapeutic approach from that of combining Oncoprex with targeted therapies such as osimertinib (marketed as Tagrisso® by AstraZeneca).
Genprex was recently awarded U.S. FDA Fast Track designation for use of Oncoprex combined with Tagrisso for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company is now preparing to file an Investigational New Drug application to initiate a clinical trial of Oncoprex in combination with pembrolizumab (marketed as Keytruda® by Merck) in NSCLC.
https://www.businesswire.com/news/home/20200505005133/en/Genprex-Enters-Exclusive-Worldwide-Patent-Technology-License

CohBar Agent Targets Covid-19 Linked Acute Respiratory Distress Syndrome

CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, announced today that it has initiated testing of its CB5064 analogs in preclinical models of ARDS, to assess their potential as therapeutics for coronavirus disease 2019 (COVID-19) associated ARDS. In preclinical studies to date, these peptides have demonstrated the ability to activate the apelin receptor, a cell signaling pathway that published preclinical studies have shown can reduce the severity of acute lung injury by reducing lung fluid accumulation, hypoxemia, and cytokine secretion, which occur in COVID-19 associated ARDS, and lead to downstream injury to the kidney, heart, and other organs.

“CohBar’s novel CB5064 analogs are agonists of the apelin receptor in vitro and also improve metabolic dysfunction in vivo in obese mice, a known apelin effect,” said Kenneth C. Cundy, PhD, CohBar’s Chief Scientific Officer. “In published preclinical studies, apelin signaling demonstrates a key role in protecting animals from acute lung injury and restoring metabolic homeostasis. Our peptides could potentially block many of the acute effects of COVID-19 associated ARDS, and their beneficial effects could extend to protecting other organs from the cytokine storm and reducing mortality in COVID-19 and other forms of acute lung injury.”
COVID-19 associated ARDS is a new target for the company’s ongoing program of CB5064 analogs. These analogs previously demonstrated efficacy in diet induced obese or DIO mice, a widely used model of type 2 diabetes, leading to significant reduction in body weight, adiposity, and improvement in insulin sensitivity, as presented by CohBar at the American Diabetes Association national meeting in 2019.ⁱ Published clinical reports show that obesity and diabetes are major underlying risk factors in severe COVID-19, and are associated with significantly increased mortality.
“Preventing ARDS in COVID-19 patients, including the damaging effects of fluid accumulation in the lungs, hypoxemia, and cytokine storm, is critical to reducing mortality,” stated Professor Toby Maher, British Lung Foundation Chair in Respiratory Research, Professor of Interstitial Lung Disease and head of the Fibrosis Research Group at the National Heart and Lung Institute, Imperial College, London, and Director of Respiratory Research at Royal Brompton Hospital, London. “Obesity and metabolic dysfunction are also major risk factors for development of severe COVID-19.  Targeting the apelin receptor to reduce lung injury while improving metabolic homeostasis is a promising strategy for treating both ARDS associated with COVID-19 and other forms of ARDS.”

https://www.globenewswire.com/news-release/2020/05/05/2027587/0/en/CohBar-To-Target-COVID-19-Associated-Acute-Respiratory-Distress-Syndrome-ARDS-with-its-Apelin-Receptor-Agonist-Peptides.html

Another 1,700 Virus Deaths Reported in New York Nursing Homes

New York state is reporting more than 1,700 previously undisclosed deaths at nursing homes and adult care facilities as the state faces scrutiny over how it has protected vulnerable residents during the coronavirus pandemic.
At least 4,813 people have died from COVID-19 in the state’s nursing homes since March 1, according to a tally released by Governor Andrew Cuomo’s administration late Monday that, for the first time, includes people believed to have been killed by the coronavirus before their diagnoses could be confirmed by a lab test.

Exactly how many nursing home residents have died remains uncertain despite the state’s latest disclosure, as the list doesn’t include nursing home residents who were transferred to hospitals before dying.
The revised list shows that 22 nursing homes, largely in New York City and Long Island, have reported at least 40 deaths.
Parker Jewish Institute in Queens and Isabella Geriatric Center — one of New York City’s largest nursing homes with 705 beds — have reported the highest number of deaths: 71 and 64, respectively.
In many cases, the state’s new figures reveal many more deaths than previously reported at nursing homes: Isabella Geriatric Center had 13 COVID-19 deaths reported as of May 1, and now reports the deaths of 21 patients who were confirmed to have COVID-19 along with 43 deaths of residents presumed to have COVID-19. And Ozanam Hall of Queens now is reporting a total of 53 deaths, up from just 10.

Several veterans homes have been especially hard-hit by the virus: The Long Island State Veterans Home has reported 53 deaths; including 48 confirmed and five presumed COVID-19 deaths. The New York State Veterans Home at St. Albans in Queens has reported 33 deaths, while New York State Veterans Home at Montrose in Westchester says 22 residents have died.
Cuomo promised on March 2, when only a handful of coronavirus cases had been reported in New York, to make a “special effort” for nursing homes and congregate homes housing senior citizens. The state directed nursing homes to screen visitors and consider modifying visiting hours on March 6, and later suspended visits to nursing homes statewide March 12.
But the governor is facing criticism over his administration’s role in overseeing and supporting New York’s overwhelmed, state-regulated nursing homes, as many have struggled to treat COVID-19 patients, amass enough personal protective gear, or ensure adequate staffing.
Advocacy groups for the elderly and family members of nursing home residents have called for greater transparency over COVID-19 cases at each state-regulated nursing home and criticized an April 1 state law granting some immunity to hospitals and nursing homes from civil and criminal liability. They also questioned the state’s March 25 policy that says “no resident shall be denied re-admission or admission to a nursing home solely based on a confirmed or suspected diagnosis of COVID-19.”
The governor and his administration have defended that policy as ensuring nursing home residents aren’t left lingering in hospitals or without anywhere else to go. Cuomo’s spokesman tweeted Monday that the policy follows federal Centers for Medicare and Medicaid Services guidance. But the federal guidance says only that a nursing home “can accept a resident diagnosed with COVID-19” so long as the nursing home can follow federal guidance on transmission precautions.
Cuomo has also said the state has facilities that can house transferred COVID-19 nursing home patients, and he recently said that nursing homes that tell the state up-front that they can’t care for a COVID-19 patient wouldn’t face regulatory scrutiny. His administration hasn’t responded to a request for questions on the state’s current capacity to care for COVID-19 nursing home residents, and whether nursing homes were informed.
https://spectrumlocalnews.com/nys/capital-region/coronavirus/2020/05/05/another-1-700-virus-deaths-reported-in-new-york-nursing-homes

Most Walgreens back to regular hours

In another sign of the return of retail normalcy, Walgreens (NASDAQ:WBA) says it will resume normal operating stores at most stores in the U.S.

Certain stores located in tourist regions, downtown city centers or markets with government-mandated curfews will continue to operate with adjusted hours.

Source: Press Release

https://seekingalpha.com/news/3569189-walgreens-back-to-regular-hours

New mutation indicates that coronavirus might be weakening – study

A mutation in the novel coronavirus mirrors a change that occurred in the genetically similar SARS virus in 2003 — indicating that the bug might be weakening, researchers announced in a newly published study.
Lead study author Dr. Efren Lim, an assistant professor at Arizona State University’s Biodesign Institute, and his team use a new technology called next-generation sequencing to rapidly read the genetic code of the coronavirus, referred to scientists as SARS-CoV-2.
That technology helps researchers to determine how the virus is spreading, mutating and adapting over time.

Out of the 382 nasal swab samples the researchers examined from coronavirus patients in the state, a single sample was missing a significant chunk of its genome. Eighty-one of the letters were permanently deleted, according to the new study published in the Journal of Virology.
“One of the reasons why this mutation is of interest is because it mirrors a large deletion that arose in the 2003 SARS outbreak,” Lim said in a statement.
During the middle and late phases of the 2003 SARS epidemic, the virus accumulated mutations that lessened its strength, according to the researchers.
“Where the deletion occurs in the genome is pretty meaningful because it’s a known immune protein which means it counteracts the host’s antiviral response,” Lim told the Daily Mail.
A weakened virus that causes less severe symptoms may get a leg up if it is able to spread efficiently through populations by people who don’t know they are infected, the scientists say.
However, it’s too soon to say whether the novel coronavirus is beginning to lose its potency, according to the researchers.
All of the patients whose samples the Arizona scientists analyzed had some clinical coronavirus symptoms — meaning that even the version with 81 deletions was still strong enough to make the patient at least somewhat sick, the Mail reported.
This is the first time such a deletion has been seen in the 16,000 coronavirus genomes that have been sequenced to date, according to the researchers.
That’s less than half a percent of the strains circulating, according to the scientists. There are about 3.6 million confirmed COVID-19 cases worldwide.
“This is a drop in the bucket,” Lim told the Mail.
“One sample is the convincing thing we need to say “look at this,”‘ meaning that if more coronavirus genomes are sequenced, scientists might find far more instances of this attenuated genome,” he said.
https://nypost.com/2020/05/05/new-mutation-indicates-that-coronavirus-might-be-weakening-study/

How Best to Help Patients Stay Insured During COVID-19?

As the COVID-19 lockdowns continue to drag on, more Americans are losing their jobs and, along with them, their health insurance. While everyone agrees this is a problem, ideas for solutions diverge.
“The pandemic has increased and will increase the number of uninsured patients,” Rick Pollack, president and CEO of the American Hospital Association (AHA), told reporters last week. “We all need to take action and stop coverage losses. This is particularly important during a public health emergency where the failure to seek care affects everyone…. To beat this virus we can have no weak links, and that means no barriers to testing or treatment. Coverage helps ensure that individuals and families have a regular provider they can turn to for screening and preventive services,” he said.

The AHA, along with the U.S. Chamber of Commerce, and America’s Health Insurance Plans (AHIP), sent a letter to congressional leaders last week with their suggestions for helping people maintain their health insurance, which included:

• Provide employers with temporary subsidies to preserve health benefits. “Many employers experiencing loss of revenue as a result of the economic downturn are compelled reluctantly to reduce benefits as one way to manage expenses. Congress could help employers by providing subsidies to offset the cost of preserving health coverage during this crisis,” the letter said.
• Cover the cost of coverage through the Consolidated Omnibus Budget Reconciliation Act (COBRA). “Many individuals may have the option to maintain their job-based health coverage through COBRA but find the costs to be prohibitive…. Congress could offset the full cost of coverage through COBRA to former employees through a direct subsidy,” the letter noted.
• Expand use of health savings accounts (HSAs). “Currently, HSAs may only be used for certain qualifying expenses, which do not include premiums. Congress could temporarily lift this limit to provide individuals and families with access to additional resources to cover the cost of coverage,” the groups said.
• Open a special enrollment period for the Affordable Care Act’s health insurance marketplaces. “While individuals who have recently lost employer-based coverage are eligible to enroll in the Marketplaces as a result of an existing Special Enrollment Period (SEP), Congress could create a new, one-time SEP for enrollment in the Marketplaces specifically for those individuals who are uninsured and not otherwise eligible for an existing SEP,” the letter said.
• Increase eligibility for federal subsidies for the health insurance marketplaces. “Some individuals and families earned too much money to qualify for Health Insurance Marketplace subsidies but too little to afford premiums. Congress could increase access to individual market coverage by increasing eligibility for federal subsidies.”

Some members of Congress are suggesting a different alternative. On Friday, representatives Pramila Jayapal (D-Wash.) and Joe Kennedy (D-Mass.) introduced the Medicare Crisis Program Act, which would expand Medicare to include anyone who lost their health insurance due to COVID-19. “Our nation’s for-profit, employment-based health care system did not make sense before COVID-19 struck, and it is proving dangerous and deadly during the crisis,” Jayapal said in a statement.
“Millions of Americans are losing their job and their health insurance at precisely the moment when we need everyone to be able to access care and treatment for illness. The Medicare Crisis Program Act would guarantee health care for millions of people struggling with the health and economic realities of the COVID-19 pandemic and protect Americans from outrageous out-of-pocket costs.”
In addition to expanding Medicare to this population, the bill would:

• Make Medicare coverage retroactive to the date of unemployment.
• Eliminate premiums and limit out-of-pocket costs at 5% of monthly income – not counting unemployment benefits – for all new and existing Medicare enrollees.
• Expand Medicaid eligibility. The legislation would enhance federal funding to states for existing Medicaid enrollees, increase the federal income eligibility threshold for Medicaid to 300% of the federal poverty level, and pay 100% of the cost for newly eligible enrollees.
• Limit out-of-pocket costs for everyone. The legislation would require Medicare, Medicaid and all other public and private health insurers to cover all costs of COVID-19-related care, including if a patient seeks cares due to COVID-19 symptoms but ultimately tests negative. It would also prohibit health care providers from billing any of these services to those who remain uninsured.

Provisions would expire when the federal and state unemployment rate returns to within 2% of the unemployment rate in the last quarter of 2019 or they are employed and enrolled in sufficient health insurance, whichever occurs first, according to the release.
In addition to the Jayapal/Kennedy bill, Jayapal and Sen. Bernie Sanders (I-Vt.) a few weeks ago introduced the Health Care Emergency Guarantee Act, which would mandate that Medicare pay all COVID-19-related healthcare expenses for uninsured patients, as well as copays, coinsurance, and deductibles related to COVID-19 care for patients with insurance.
https://www.medpagetoday.com/infectiousdisease/covid19/86298