Cleveland Clinic-owned hospital system pays $21M to settle False Claims allegations

Dive Brief:

  • A Cleveland Clinic-owned hospital system in Akron, Ohio, is paying the federal government $21.3 million to settle claims it illegally billed the Medicare program.
  • Akron General Health System allegedly overpaid physicians well above market value for referring physicians to the system, violating the Anti-Kickback Statute and Physician Self-Referral Law, and then billed Medicare for the improperly referred business, violating the False Claims Act, between August 2010 and March 2016.
  • Along with an AGHS whistleblower, the Cleveland Clinic Foundation, which acquired the system at the end of 2015, voluntarily disclosed to the federal government its concerns with the compensation arrangements, which were enacted by AGHS’ prior leadership, the Department of Justice said Friday.

Dive Insight:

The Anti-Kickback Statute forbids providers from paying for or otherwise soliciting other parties to get them to refer patients covered by federal programs like Medicare, while the Physician Self-Referral Law, otherwise known as the Stark Law, prohibits a hospital from billing for those services. Despite the laws and a bevy of other regulations resulting in a barrage of DOJ lawsuits and been a thorn in the side of providers for decades, fraud is still rampant in healthcare.

Of the more than $3 billion recovered by the government in 2019 from fraud and false claims, almost 90% involved the healthcare industry, according to DOJ data.

“Physicians must make referrals and other medical decisions based on what is best for patients, not to serve profit-boosting business arrangements,” HHS Office of Inspector General Special Agent in Charge Lamont Pugh said in a statement on the AGHS settlement.

Cleveland Clinic struck a deal with AGHS in 2014, agreeing to pay $100 million for minority ownership in the system. The agreement gave the clinic the option to fully acquire AGHS after a year, which it exercised as soon as that period expired in August 2015.

The settlement stems from a whistleblower suit brought by AGHS’s former Director of Internal Audit Beverly Brouse, who will receive a portion of the settlement, the DOJ said. The False Claims Act allows whistleblowers to share in the proceeds of a suit.

As fraud has increased in healthcare over the past decade — the DOJ reported 247 new matters for potential investigation in 2000, 427 in 2010 and 505 in 2019 — the federal government has renewed its efforts to crack down on illegal schemes. That’s resulted in the formation of groups like the Medicare Fraud Strike Force in 2007 and the Opioid Fraud and Abuse Detection Unit in 2017, which has in turn resulted in the DOJ recovering huge sums in stings, settlements and guilty verdicts.

Some of the biggest settlements reach into the hundreds of millions, and involve billions in false claims.

In 2018, DOJ charged more than 600 people for falsely billing federal programs more than $2 billion; last year federal agencies charged almost 350 people for submitting more than $6 billion in false claims. That last case led to creation of a rapid response strike force to investigate fraud involving major providers in multiple geographies.

Other large settlements include Walgreens’ $270 million fine in 2019 to settle lawsuits accusing the pharmacy giant of improperly billing Medicare and Medicaid for drug reimbursements; hospital operator UHS’ $122 million settlement last summer finalizing a fraudulent billing case with the DOJ after being accused of fraudulently billing Medicare and Medicaid for services at its behavioral healthcare facilities; and West Virginia’s oldest hospital, nonprofit Wheeling Hospital, agreeing in September to pay $50 million to settle allegations it systematically violated the laws against physician kickbacks, improper referrals and false billing.

EHR vendor eClinicalWorks paid $155 million to settle False Claims Act allegations around misrepresentation of software capabilities in 2017, while Florida-based EHR vendor Greenway Health was hit with a $57.3 million fine in 2019 to to settle allegations the vendor caused users to submit false claims to the EHR Incentives Program.

Benjamin Franklin’s fight against a deadly virus: Colonial America was divided over smallpox inoculation, but he championed science to skeptics

Benjamin Franklin's fight against a deadly virus: Colonial America was divided  over smallpox inoculation, but he championed science to skeptics

Exactly 300 years ago, in 1721, Benjamin Franklin and his fellow American colonists faced a deadly smallpox outbreak. Their varying responses constitute an eerily prescient object lesson for today’s world, similarly devastated by a virus and divided over vaccination three centuries later.

As a microbiologist and a Franklin scholar, we see some parallels between then and now that could help governments, journalists and the rest of us cope with the coronavirus pandemic and future threats.

Smallpox strikes Boston

Smallpox was nothing new in 1721. Known to have affected people for at least 3,000 years, it ran rampant in Boston, eventually striking more than half the city’s population. The virus killed about 1 in 13 residents – but the death toll was probably more, since the lack of sophisticated epidemiology made it impossible to identify the cause of all deaths.

What was new, at least to Boston, was a simple procedure that could protect people from the disease. It was known as “variolation” or “inoculation,” and involved deliberately exposing someone to the smallpox “matter” from a victim’s scabs or pus, injecting the material into the skin using a needle. This approach typically caused a mild disease and induced a state of “immunity” against smallpox.

Even today, the exact mechanism is poorly understood and not much research on variolation has been done. Inoculation through the skin seems to activate an immune response that leads to milder symptoms and less transmission, possibly because of the route of infection and the lower dose. Since it relies on activating the immune response with live smallpox variola virus, inoculation is different from the modern vaccination that eradicated smallpox using the much less harmful but related vaccinia virus.

The inoculation treatment, which originated in Asia and Africa, came to be known in Boston thanks to a man named Onesimus. By 1721, Onesimus was enslaved, owned by the most influential man in all of Boston, the Rev. Cotton Mather.

etching of an 18th century man in white wig
Cotton Mather heard about variolation from an enslaved West African man in his household named Onesimus. Bettman via Getty Images

Known primarily as a Congregational minister, Mather was also a scientist with a special interest in biology. He paid attention when Onesimus told him “he had undergone an operation, which had given him something of the smallpox and would forever preserve him from it; adding that it was often used” in West Africa, where he was from.

Inspired by this information from Onesimus, Mather teamed up with a Boston physician, Zabdiel Boylston, to conduct a scientific study of inoculation’s effectiveness worthy of 21st-century praise. They found that of the approximately 300 people Boylston had inoculated, 2% had died, compared with almost 15% of those who contracted smallpox from nature.

The findings seemed clear: Inoculation could help in the fight against smallpox. Science won out in this clergyman’s mind. But others were not convinced.

Stirring up controversy

A local newspaper editor named James Franklin had his own affliction – namely an insatiable hunger for controversy. Franklin, who was no fan of Mather, set about attacking inoculation in his newspaper, The New-England Courant.

frontpage of a 1721 newspaper
From its first edition, The New-England Courant covered inoculation. Wikimedia Commons

One article from August 1721 tried to guilt readers into resisting inoculation. If someone gets inoculated and then spreads the disease to someone else, who in turn dies of it, the article asked, “at whose hands shall their Blood be required?” The same article went on to say that “Epidemeal Distempers” such as smallpox come “as Judgments from an angry and displeased God.”

In contrast to Mather and Boylston’s research, the Courant’s articles were designed not to discover, but to sow doubt and distrust. The argument that inoculation might help to spread the disease posits something that was theoretically possible – at least if simple precautions were not taken – but it seems beside the point. If inoculation worked, wouldn’t it be worth this small risk, especially since widespread inoculations would dramatically decrease the likelihood that one person would infect another?

Franklin, the Courant’s editor, had a kid brother apprenticed to him at the time – a teenager by the name of Benjamin.

Historians don’t know which side the younger Franklin took in 1721 – or whether he took a side at all – but his subsequent approach to inoculation years later has lessons for the world’s current encounter with a deadly virus and a divided response to a vaccine.

Independent thought

You might expect that James’ little brother would have been inclined to oppose inoculation as well. After all, thinking like family members and others you identify with is a common human tendency.

That he was capable of overcoming this inclination shows Benjamin Franklin’s capacity for independent thought, an asset that would serve him well throughout his life as a writer, scientist and statesman. While sticking with social expectations confers certain advantages in certain settings, being able to shake off these norms when they are dangerous is also valuable. We believe the most successful people are the ones who, like Franklin, have the intellectual flexibility to choose between adherence and independence.

Truth, not victory

etching of Franklin standing at a table in a lab
Franklin matured into a well-known scientist and statesman, with many successes aided by his open mind. Universal History Archive/Universal Images Group via Getty Images

What happened next shows that Franklin, unlike his brother – and plenty of pundits and politicians in the 21st century – was more interested in discovering the truth than in proving he was right.

Perhaps the inoculation controversy of 1721 had helped him to understand an unfortunate phenomenon that continues to plague the U.S. in 2021: When people take sides, progress suffersTribes, whether long-standing or newly formed around an issue, can devote their energies to demonizing the other side and rallying their own. Instead of attacking the problem, they attack each other.

Franklin, in fact, became convinced that inoculation was a sound approach to preventing smallpox. Years later he intended to have his son Francis inoculated after recovering from a case of diarrhea. But before inoculation took place, the 4-year-old boy contracted smallpox and died in 1736. Citing a rumor that Francis had died because of inoculation and noting that such a rumor might deter parents from exposing their children to this procedure, Franklin made a point of setting the record straight, explaining that the child had “receiv’d the Distemper in the common Way of Infection.”

Writing his autobiography in 1771, Franklin reflected on the tragedy and used it to advocate for inoculation. He explained that he “regretted bitterly and still regret” not inoculating the boy, adding, “This I mention for the sake of parents who omit that operation, on the supposition that they should never forgive themselves if a child died under it; my example showing that the regret may be the same either way, and that, therefore, the safer should be chosen.”

A scientific perspective

A final lesson from 1721 has to do with the importance of a truly scientific perspective, one that embraces science, facts and objectivity.

19th-century photo of a smallpox patient
Smallpox was characterized by fever and aches and pustules all over the body. Before eradication, the virus killed about 30% of those it infected, according to the U.S. Centers for Disease Control and Prevention. Sepia Times/Universal Images Group via Getty Images

Inoculation was a relatively new procedure for Bostonians in 1721, and this lifesaving method was not without deadly risks. To address this paradox, several physicians meticulously collected data and compared the number of those who died because of natural smallpox with deaths after smallpox inoculation. Boylston essentially carried out what today’s researchers would call a clinical study on the efficacy of inoculation. Knowing he needed to demonstrate the usefulness of inoculation in a diverse population, he reported in a short book how he inoculated nearly 300 individuals and carefully noted their symptoms and conditions over days and weeks.

The recent emergency-use authorization of mRNA-based and viral-vector vaccines for COVID-19 has produced a vast array of hoaxes, false claims and conspiracy theories, especially in various social media. Like 18th-century inoculations, these vaccines represent new scientific approaches to vaccination, but ones that are based on decades of scientific research and clinical studies.

We suspect that if he were alive today, Benjamin Franklin would want his example to guide modern scientists, politicians, journalists and everyone else making personal health decisions. Like Mather and Boylston, Franklin was a scientist with a respect for evidence and ultimately for truth.

When it comes to a deadly virus and a divided response to a preventive treatment, Franklin was clear what he would do. It doesn’t take a visionary like Franklin to accept the evidence of medical science today.

More hospitals poised to require COVID-19 vaccines

It’s “a trickle that will become a torrent,” Ashish Jha, dean at Brown University’s School of Public Health, tweeted.

More hospitals are likely to require employees receive a COVID-19 vaccine, experts said, to further protect the sick and vulnerable patients who rely on them for care.

A Houston-area hospital captured headlines after taking a firm stance on requiring vaccines that prevent severe illness of the coronavirus, which has killed more than 600,000 in the U.S. and ravaged the economy.

Houston Methodist employees who refused the vaccine were either terminated or resigned. A judge earlier this month sided with the hospital and tossed out an employee lawsuit that was seeking to block the mandated inoculation. The ruling may give other hospitals the green light to require the jab, and as more facilities put a similar policy in place, others are likely to follow, experts said.

It’s “a trickle that will become a torrent,” Ashish Jha, professor and dean at Brown University’s School of Public Health, posted Thursday on Twitter.

3 large health systems in Massachusetts to require all workers to be vaccinated.

Given the critical need to protect vulnerable patients, its critical all hospitals do this.

Leading systems will do it soon.

Laggards will get there eventually.

Joining the growing tide of vaccine mandates are a variety of systems and hospitals, including Mass General Brigham in Boston, BJC Healthcare in St. Louis and Inova Health System in Virginia.

Some of the nation’s largest health systems have yet to mandate the shot, including Kaiser Permanente and CommonSpirit Health.

“Vaccination will only be required for Kaiser Permanente employees if a state or county where we operate mandates the vaccine for health care workers,” the company said in an email.

The American Hospital Association continues to hear that a growing number of its members are requiring the vaccine, with some exemptions. However, many member hospitals are waiting until the FDA grants full approval, a time when more safety and efficacy data will be made available.

“Getting vaccinated is especially critical for health care professionals because they work with patients with underlying health conditions whose immune systems may be compromised,” AHA, which has not taken on stance on the requirement, said in a statement.

The mandates raise ethical questions, some say, pointing to the profession’s promise to “do no harm.”

Arthur Caplan, head of medical ethics at New York University School of Medicine, said the codes of ethics that doctors and nurses says to put patients first, do no harm and protect the vulnerable.

“Of course they should be vaccinated,” he said. “If they don’t want to get vaccinated, I think they’re in the wrong profession.”

The Equal Employment Opportunity Commission said employment law does not prohibit employers from requiring the jab, essentially giving the green light to employers to put incentives and requirements in place for their workers. The EEOC is the federal agency tasked with ensuring that workplaces do not discriminate.

Some states are going against the tide and signing legislation that bars vaccine mandates, including Florida. The city of San Francisco will require hospital employees and workers in high-risk settings to get the vaccine. San Francisco, like other employers and universities, will require all city workers get inoculated.

The differing policy stances across the country creates additional hurdles for corporations with a large footprint.

The Worst-Case COVID-19 Predictions Turned Out To Be Wrong. So Did the Best-Case Predictions.

http://www.reason.com/2021/06/22/

CrystalBallDoctorDreamstime

An argument for humility in the face of pandemic forecasting unknown unknowns.

“Are we battling an unprecedented pandemic or panicking at a computer generated mirage?” I asked at the beginning of the COVID-19 pandemic on March 18, 2020. Back then the Imperial College London epidemiological model’s baseline scenario projected that with no changes in individual behaviors and no public health interventions, more than 80 percent of Americans would eventually be infected with novel coronavirus and about 2.2 million would die of the disease. This implies that 0.8 percent of those infected would die of the disease. This is about 8-times worse than the mortality rate from seasonal flu outbreaks.

Spooked by these dire projections, President Donald Trump issued on March 16 his Coronavirus Guidelines for America that urged Americans to “listen to and follow the directions of STATE AND LOCAL AUTHORITIES.” Among other things, Trump’s guidelines pressed people to “work or engage in schooling FROM HOME whenever possible” and “AVOID SOCIAL GATHERINGS in groups of more than 10 people.” The guidelines exhorted Americans to “AVOID DISCRETIONARY TRAVEL, shopping trips and social visits,” and that “in states with evidence of community transmission, bars, restaurants, food courts, gyms, and other indoor and outdoor venues where people congregate should be closed.”

Let’s take a moment to recognize just how blindly through the early stages of the pandemic we—definitely including our public health officials—were all flying at the time. The guidelines advised people to frequently wash their hands, disinfect surfaces, and avoid touching their faces. Basically, these were the sort of precautions typically recommended for influenza outbreaks. On July 9, 2020, an open letter from 239 researchers begged the World Health Organization and other public health authorities to recognize that COVID-19 was chiefly spread by airborne transmission rather than via droplets deposited on surfaces. The U.S. Centers for Disease Control and Prevention (CDC) didn’t update its guidance on COVID-19 airborne transmission until May 2021. And it turns out that touching surfaces is not a major mode of transmission for COVID-19.

The president’s guidelines also advised, “IF YOU FEEL SICK, stay home. Do not go to work.” This sensible advice, however, missed the fact that a huge proportion of COVID-19 viral transmission occurred from people without symptoms. That is, people who feel fine can still be infected and, unsuspectingly, pass along their virus to others. For example, one January 2021 study estimated that “59% of all transmission came from asymptomatic transmission, comprising 35% from presymptomatic individuals and 24% from individuals who never develop symptoms.”

The Imperial College London’s alarming projections did not go uncontested. A group of researchers led by Stanford University medical professor Jay Bhattacharya believed that COVID-19 infections were much more widespread than the reported cases indicated. If the Imperial College London’s hypothesis were true, Bhattacharya and his fellow researchers argued, that would mean that the mortality rate and projected deaths from the coronavirus would be much lower, making the pandemic much less menacing.

The researchers’ strategy was to blood test people in Santa Clara and Los Angeles Counties in California to see how many had already developed antibodies in response to coronavirus infections. Using those data, they then extrapolated what proportion of county residents had already been exposed to and recovered from the virus.

Bhattacharya and his colleagues preliminarily estimated that between 48,000 and 81,000 people had already been infected in Santa Clara County by early April, which would mean that COVID-19 infections were “50-85-fold more than the number of confirmed cases.” Based on these data the researchers calculated that toward the end of April “a hundred deaths out of 48,000-81,000 infections corresponds to an infection fatality rate of 0.12-0.2%.” As I optimistically reported at the time, that would imply that COVID-19’s lethality was not much different than for seasonal influenza.

Bhattacharya and his colleagues conducted a similar antibody survey in Los Angeles County. That study similarly asserted that COVID-19 infections were much more widespread than reported cases. The study estimated 2.8 to 5.6 percent of the residents of Los Angeles County had been infected by early April. That translates to approximately 221,000 to 442,000 adults in the county who have had the infection. “That estimate is 28 to 55 times higher than the 7,994 confirmed cases of COVID-19 reported to the county by the time of the study in early April,” noted the accompanying press release. “The number of COVID-related deaths in the county has now surpassed 600.” These estimates would imply a relatively low infection fatality rate of between 0.14 and 0.27 percent. 

Unfortunately, from the vantage of 14 months, those hopeful results have not been borne out. Santa Clara County public health officials report that there have been 119,712 diagnosed cases of COVID-19 so far. If infections were really being underreported by 50-fold, that would suggest that roughly 6 million Santa Clara residents would by now have been infected by the coronavirus. The population of the county is just under 2 million. Alternatively, extrapolating a 50-fold undercount would imply that when 40,000 diagnosed cases were reported on July 11, 2020, all 2 million people living in Santa Clara County had been infected by that date.

Los Angeles County reports 1,247,742 diagnosed COVID-19 cases cumulatively. Again, if infections were really being underreported 28-fold, that would imply that roughly 35 million Angelenos out of a population of just over 10 million would have been infected with the virus by now. Again turning the 28-fold estimate on its head, that would imply that all 10 million Angelenos would have been infected when 360,000 cases had been diagnosed on November 21, 2020.

COVID-19 cases are, of course, being undercounted. Data scientist Youyang Gu has been consistently more accurate than many of the other researchers parsing COVID-19 pandemic trends. Gu estimates that over the course of the pandemic, U.S. COVID-19 infections have roughly been 4-fold greater than diagnosed cases. Applying that factor to the number of reported COVID-19 cases would yield an estimate of 480,000 and 5,000,000 total infections in Santa Clara and Los Angeles respectively. If those are ballpark accurate, that would mean that the COVID-19 infection fatality rate in Santa Clara is 0.46 percent and is 0.49 percent in Los Angeles. Again, applying a 4-fold multiplier to take account of undercounted infections, those are both just about where the U.S. infection fatality rate of 0.45 percent is now.

The upshot is that, so far, we have ended up about half-way between the best case and worst case scenarios sketched out at the beginning of the pandemic.

Kansas Heart Hospital accuses former CFO, COO of stealing funds

Binghamton Embezzlement Lawyer | Embezzlement Charges in NY

The Kansas Heart Hospital in Wichita filed a lawsuit against two former executives, claiming they stole money from the facility and improperly used CARES Act funds, according to ABC affiliate KAKE and court documents.  

The lawsuit, filed April 29 in the U.S. District Court in Kansas, accuses the hospital’s former COO Joyce Heismeyer and former CFO Steve Smith of stealing funds between 2015 and 2020. During that time, Kansas Heart Hospital lost more than $31 million, according to the lawsuit.

Ms. Heismeyer and Mr. Smith abruptly stepped down from their roles in fall 2020. The hospital claims the former executives set up large severance payments for themselves before their departures, which prompted an internal investigation.

In its complaint, Kansas Heart Hospital alleges that Ms. Heismeyer and Mr. Smith conspired with the hospital’s former president, Gregory Duick, MD, to divert more than $6 million in hospital funds for undisclosed bonuses and benefits during the five-year period. Additionally, the hospital claims all three sent millions in hospital dollars to an investment account that Dr. Duick owned. 

Kansas Heart Hospital also claims the three caused it to lose out on $4.4 million in CARES Act payments. The funds were returned to avoid a federal audit, the lawsuit alleges, but the former executives said the funds were returned because the hospital hadn’t treated any COVID-19 patients.

Dr. Duick also retired from his role in fall 2020. He is named in the lawsuit but is not a defendant, and did not immediately return KAKE‘s request for comment.

In a statement to KAKE, an attorney for Ms. Heismeyer and Mr. Smith said, “Joyce and Steve vehemently deny the allegations and will aggressively defend themselves and expect to clear their names in court.” Additionally, the statement said, “We are disappointed by the Kansas Heart Hospital’s plan to sue and tarnish the reputations of two long time employees.”

Deborah Birx says Trump received a “parallel set of data” on the coronavirus

https://www.washingtonpost.com/politics/2021/01/25/health-202-hospitals-drag-feet-new-regulations-disclose-costs-medical-services/

The former White House coronavirus response coordinator told CBS News’s “Face The Nation” that she saw Trump presenting graphs about the coronavirus that she did not help make. Someone inside or outside of the administration, she said, “was creating a parallel set of data and graphics that were shown to the president.”

Birx also said that there were people in the White House who believed the coronavirus was a hoax and that she was one of only two people in the White House who routinely wore masks.

Birx was often caught between criticism from Trump, who at one point called her “pathetic” on Twitter when she contradicted his more optimistic predictions for the virus, and critics in the scientific community who thought she did not do enough to combat false information about the virus from TrumpThe Post’s Meryl Kornfield reports.

“Colleagues of mine that I’d known for decades — decades — in that one experience, because I was in the White House, decided that I had become this political person, even though they had known me forever,” she told CBS. “I had to ask myself every morning, ‘Is there something that I think I can do that would be helpful in responding to this pandemic?’ And it’s something I asked myself every night.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the New York Times that Trump repeatedly tried to minimize the severity of the virus and would often chide him for not being positive enough in his statements about the virus. 

Fauci also described facing death threats as he was increasingly vilified by the president’s supporters. “One day I got a letter in the mail, I opened it up and a puff of powder came all over my face and my chest,” he said. The powder turned out to be benign.

Cartoon – History Repeating Itself (Covid-19)

Editorial Cartoon: COVID-19 returns | Opinion | dailyastorian.com