All care, no responsibility

Lexology has a great article today, written by and courtesy of lawyers from Arent Fox LLP. The article is, "Headlines that Matter for Companies and Executives in Regulated Industries".

Now, what is so great about that? It pinpoints some of the underpinnings of the outrageously expensive health care in the USA. Or, perhaps more to the point, the sabotage of them by "the system".

And, its a catalogue.

Item One: Florida Health Care Facility Owner Convicted in $1.3 Billion Fraud Scheme

After an eight-week trial, a federal jury in Florida convicted a health care facility owner for orchestrating one of the largest health care fraud schemes in US history. The case involved over $1.3 billion in fraudulent claims to Medicare and Medicaid for services that the jury found were not provided, were not medically necessary or were procured through the payment of kickbacks.

Helpfully, it links to the Department of Justice press release.

After an eight-week trial, Philip Esformes, 50, of Miami Beach, Florida, was convicted of one count of conspiracy to defraud the United States, two counts of receipt of kickbacks in connection with a federal health care program, four counts of payment of kickbacks in connection with a federal health care program, one count of conspiracy to commit money laundering, nine counts of money laundering, two counts of conspiracy to commit federal program bribery, and one count of obstruction of justice before U.S. District Judge Robert N. Scola Jr. of the Southern District of Florida.

Philip Esformes’ criminal scheme defrauded America’s health care system out of millions of dollars, that would have otherwise provided quality care to patients in need,” said U.S. Attorney Fajardo Orshan. This massive fraud scheme, perpetuated in nursing and assisted living facilities in our South Florida communities, compromised the integrity of our local health care system. Philip Esformes is a man driven by almost unbounded greed,” said Assistant Special Agent in Charge Denise M. Stemen of FBI Miami. “The illicit road Esformes took to satisfy his greediness led to over $800 million in fraudulent health care claims, the largest amount ever charged by the Department of Justice. Along that road, Esformes cycled patients through his facilities in poor condition where they received inadequate or unnecessary treatment, then improperly billed Medicare and Medicaid. Taking his despicable conduct further, he bribed doctors and regulators to advance his criminal conduct and even bribed a college official in exchange for gaining admission for his son to that university.

The FBI and its partners are constantly investigating health care fraudsters, big and small, who steal money from taxpayers at the expense of patients in need of quality medical care.

Say what!? Constantly investigating US health car fraudsters?

More juicy still is the link of this story to another outrage: the buying of seats at US colleges, which is a poke in the eye of the democratically minded merit testing system.

The evidence further showed that Esformes used his criminal proceeds to make a series of extravagant purchases, including luxury automobiles and a $360,000 watch. Esformes also used criminal proceeds to bribe the basketball coach at the University of Pennsylvania in exchange for his assistance in gaining admission for his son into the university.

Item Two: British Drug Maker Indivior Indicted For Opioid Marketing Fraud

On Tuesday, a federal grand jury indicted Indivior Inc., formerly known as Reckitt Benckiser Pharmaceuticals Inc., and Indivior PLC (collectively, Indivior) on charges that the companies orchestrated a “nationwide scheme” in the US to falsely market their under-the-tongue Suboxone Film. The criminal charges against the publicly traded British pharmaceutical giant include conspiracy, health care fraud, mail fraud and wire fraud. Federal prosecutors allege that Indivior exaggerated the benefits of its Suboxone Film, a new version of Indivior’s older opioid dependence pill, as a more child-proof and less addictive version of the drug’s tablet form. Notwithstanding the fact that the primary ingredient in both Suboxone Film and tablets is buprenorphine, a highly potent opioid.

The government further alleges that Indivior set up an internet and telephone “Here to Help” program to connect opioid-addicted patients to doctors that the companies “knew were prescribing Suboxone and/or other opioids in a careless and clinically unwarranted manner.” The 50-page, 28-count indictment seeks forfeiture of at least $3 billion.

And, another DOJ press release:

The deadly opioid epidemic continues to devastate communities and families across our nation,” said Principal Deputy Associate Attorney General Jesse Panuccio of the Department of Justice. “The Department of Justice intends to hold accountable those who are in position to know the harm opioid abuse inflicts, but instead choose to profit illegally from the pain of others. Manufacturers, distributors, pharmacies, and doctors should all be on notice that they must follow the law and act responsibly.” Assistant Attorney General Jody Hunt said, “Opioid addiction is a national epidemic. The indictment alleges that, rather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse.”

Touted as a resource for opioid-addicted patients, Indivior used the program in part to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in suspect circumstances. The indictment alleges that Indivior executives and employees knew from statistical and numerous firsthand reports that some doctors in the Here to Help referral system were issuing prescriptions in a careless and clinically unwarranted manner.

Indivior’s scheme, as asserted in the indictment, was highly successful, converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government. Until earlier this year, when Suboxone Film became subject to generic competition, Indivior retained a high portion of the opioid-addiction treatment market.

“Our indictment alleges a wide-ranging and truly shameful scheme to put profits over the health and well-being of patients trying to manage substance use disorder and opioid dependence,” said Attorney General Mark R. Herring. “It’s incredibly frustrating that while we have been working to remove the stigma around medication-assisted treatment and make it more widely available, Indivior was allegedly conspiring to exploit patients, taxpayers, and the expansion of MAT.

This investigation revealed that Indivior tried to mislead FDA and game the system by attempting to bar competition for Suboxone from the market,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs.

Item Three: Oklahoma Doctors Settle Allegations of Pain Cream Prescription Kickbacks, and yet another DOJ press release:

Two more Tulsa doctors have entered into settlement agreements with the U.S. Attorney’s Office for allegedly accepting illegal kickback payments from OK Compounding, LLC, announced U.S. Attorney Trent Shores. Lam Nguyen, 47, a licensed doctor of osteopathic medicine, agreed to pay the government $124,139.98 for allegedly accepting illegal kickback payments from OK Compounding. In a separate settlement, Hugo Salguero, 44, a licensed medical doctor specializing in pain medicine, agreed to pay the government $228,301.76 for allegedly accepting illegal kickback payments from OK Compounding. Since January 2019, seven medical professionals have settled for allegedly receiving kickback payments from the company.

Beginning in 2013, Dr. Nguyen and Dr. Salguero prescribed pain creams for their patients, facilitating the sale and distribution of the creams. As compensation for their services, OK Compounding paid the doctors based upon an hourly rate. However, the payments the two physicians received from the company were, in actuality, kickbacks. Because some of the patients were insured by Medicare, Tricare, and the Veterans Health Administration, the kickbacks were in violation of the False Claims Act.

"These settlements highlight the Defense Criminal Investigative Service (DCIS) and its law enforcement partners' commitment to aggressively investigate health care providers who defraud the Department of Defense (DoD) health care program known as TRICARE, to preserve American taxpayer dollars intended to care for our warfighters, their family members and military retirees," said DCIS Special Agent in Charge Michael C. Mentavlos.

Item Four: ‘Closed Door’ Michigan Pharmacy Owner and Pharmacist Charged with Health care Fraud, and yet another press release:

According to the indictment, between January 2010 and January 2018, Wansa Makki owned and oversaw the operations of two local pharmacies, LifeCare Pharmacy in Livonia and LifeCare of Michigan in Farmington Hills. Mohamad Makki was the pharmacist-in-charge at both pharmacies. Both pharmacies were “closed door” pharmacies, meaning that they were not open to the public and only filled prescriptions for individuals associated with various care facilities. The indictment alleges that during the course of the conspiracy, Wansa Makki and Mohamad Makki billed Medicare, Medicaid and Blue Cross Blue Shield of Michigan for approximately $9.2 million dollars for medications that were never dispensed. The fraud scheme was detected by Medicare, in part, because of a huge deficit between each pharmacy’s recorded inventories and the claims that each submitted for insurance reimbursement. As part of the scheme to defraud, the defendants billed insurance companies for allegedly submitting claims for delivering over 500 medications to people who had died prior to the claimed date of delivery.

According to the indictment and related criminal complaints, proceeds of the fraud scheme were laundered by overpaying consulting and delivery companies operated by close relatives of Wansa and Mohamad Makki. For instance, according to the complaints, Hossam Tanana was previously convicted for diverting controlled substances such as oxycodone, hydrocodone (Vicodin) and alprazolam (Xanax) while being licensed as a pharmacist. Two days after being released from federal custody in April of 2012, Tanana incorporated a pharmacy consulting company. Between the date of incorporation and December of 2013, Tanana’s consulting company received over $400,000 from the LifeCare Pharmacy. LifeCare Pharmacy also paid over one million dollars to a delivery service opened by Wansa Makki’s brother, Mahmoud Makki, in a 14-month period beginning in December of 2013.

An indictment is only a charge and is not evidence of guilt. Each defendant is entitled to a fair trial in which it will be the government's burden to prove guilt beyond a reasonable doubt.

Doctors, heal thy selves.

Of course, there's also Big Pharma.... 

Drug Distributor And Former Execs Face First Criminal Charges In Opioid Crisis

Rochester Drug Co-Operative Inc., one of the nation's 10 largest pharmaceutical distributors in the U.S., its former CEO Laurence Doud III and former chief of compliance William Pietruszewski were charged with conspiracy to distribute controlled narcotics — oxycodone and fentanyl — for non-medical reasons and conspiracy to defraud the United States. RDC and Pietruszewski are also charged with willfully failing to file suspicious order reports to the Drug Enforcement Administration. Both executives face maximum sentences of life in prison and a mandatory minimum prison term of 10 years on the drug trafficking charges. They face a maximum five years in prison on the charge of defrauding the government.

The Rochester, N.Y.,-based company is a middleman between drug manufacturers and local independent pharmacies. It supplied more than 1,300 pharmacies and earned $1 billion per year during the relevant time period."This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country," U.S. Attorney for the Southern District of New York Geoffrey Berman said in a statement. "Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms."

According to the U.S. Attorney's statement:

"From 2012 to 2016, RDC's sales of oxycodone tablets grew from 4.7 million to 42.2 million – an increase of approximately 800 percent – and during the same period RDC's fentanyl sales grew from approximately 63,000 dosages in 2012 to over 1.3 million in 2016 – an increase of approximately 2,000 percent. During that same time period, Doud's compensation increased by over 125 percent, growing to over $1.5 million in 2016."

The company has agreed to pay a $20 million fine and submitted to three years of independent compliance monitoring. "We made mistakes," company spokesman Jeff Eller said in a statement.

Truth in Advertising

Toxic Waste Bars Have Hazardous Levels Of Lead, Recalled

The recall refers to all flavors of "Toxic Waste® brand Nuclear Sludge® Chew Bars", net weight 0.7oz (20g) package.

These candy products are made in Pakistan.

According to the California Department of Public Health (CDPH), lot number 8288A (cherry flavor) had levels of lead which have the potential to cause health problems, especially among small children, infants and pregnant mothers.

The company says it is recalling all lots and flavors distributed since 2007 "out of an abundance of caution".

The following products are included in this recall:

* Toxic Waste® Nuclear Sludge® Cherry Chew Bar - UPC 0 89894 81430 6
* Toxic Waste® Nuclear Sludge® Sour Apple Chew Bar - UPC 0 10684 81410 7
* Toxic Waste® Nuclear Sludge® Blue Raspberry Chew Bar - UPC 0 89894 81420 7.

Guambat did not make this up.

Couldn't possibly.

Latest wrinkle in Allergan case

600 million Botox settlement

Allergan Inc., maker of the wrinkle smoother Botox, said it agreed to pay $600 million and plead guilty to a single misdemeanor charge in settling a U.S. investigation of its marketing practices.

Allergan will pay $375 million to the government as part of a “misbranding” charge that the marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy, which were not approved by the Food and Drug Administration during that time.

Allergan will also pay $225 million to resolve civil claims from the Justice Department, the company said Wednesday in a statement.


Read more: http://www.kansascity.com/2010/09/01/2194022/consumer-memo-botox-settlement.html#ixzz0yLceJuM4

Health care reform with a grain of salt

The Tea Party Democrats and Republicans did their dead level best to derail health care reform, in one aspect, but ...

Lawmakers urge FDA to move swiftly to limit amount of salt in foods

Two members of Congress urged the Food and Drug Administration on Tuesday to move quickly to limit the amount of salt in processed foods, calling the matter a "public health crisis" that demanded a swift response from government.

The analogy is chuckle-able in Guambat's delinked mind.

Resist magnetic attraction

Magnets 'can modify our morality'

Scientists have shown they can change people's moral judgements by disrupting a specific area of the brain with magnetic pulses.

And by using magnetic pulses to block cell activity they impaired volunteers' notion of right and wrong.

The small Massachusetts Institute of Technology study appears in Proceedings of the National Academy of Sciences.

the researchers found that when the RTPJ was disrupted volunteers were more likely to judge actions solely on the basis of whether they caused harm - not whether they were morally wrong in themselves.

Morally dubious acts with a "happy" ending were often deemed acceptable.

OK, so does the ubiquitous telephone, and now cell/mobile phone, have any part to play in this loose morals phenomenon?

They identified a region of the brain just above and behind the right ear which appears to control morality.

Keep your hands outa my genes

Judge Invalidates Human Gene Patent

A federal judge on Monday struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property.

In fact, many in the patent field had predicted the courts would throw out the suit.

Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.

“If a decision like this were upheld, it would have a pretty significant impact on the future of medicine,” said Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief on the side of Myriad. He said that medicine was becoming more personalized, with genetic tests used not only to diagnose diseases but to determine which medicine was best for which patient.

Mr. Chahine, who once ran a biotechnology company, said the decision could also make it harder for young companies to raise money from investors. “The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection,” he said.

Edward Reines, a patent lawyer who represents biotechnology firms but was not involved in the case, said loss of patent protection could diminish the incentives for genetic research.

Chris Hansen, an A.C.L.U. staff lawyer, said: “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”

So, is US health care a sop or soporific?

There has been a nagging feeling deep in the back of Guambat head, way back in the thickest part where light don't shine, that Obama's heart was never really in the health care reform debate. Sure, it's something that, on principle, seems worthy, and many consider necessary. But, was it his fight, or Hilary's?

Guambat just can't help but feel the whole political row was just a bone tossed to Hilary to get her at least not off side, if not on.

Adding fuel to the wild speculation is the Chicago homeboy's Chicago Tribune, now tossing in the towel, hospital gown and tissues (to mop up the crocodile tears).

Time to Pull the Plug on Health-Care 'Reform'

Health-care reform is on life support now, and it's time to consider pulling the plug and letting it die peacefully.

It was a great idea, and there was and will remain a great need for the kind of radical reform that will pry the cold hands of Wall Street and the corporate boards from around the neck of medical care in our country.

There was some of that kind of reform in the first bills that began the long journey through the minefields of the U.S. Senate, but a cabal of blue dog Democrats and Republican know-nothings has pulled every tooth.

Our new president who arrived promising that he'd do everything to pass health-care reform did very little in the face of a big-money onslaught by an army of lobbyists for the big pharmaceutical corporations, the health insurance industry and other parts of the for-profit health-care industry.

His biggest mistake of all, however, was leaving it to Congress to negotiate the whole reform package in closed-door meetings of six senators here, 10 senators there, in committees controlled by senators whose votes already had been bought and paid for by the health-care corporations.

Where was the bold and courageous leadership so necessary for this badly needed initiative?

Whatever; hopefully Obama has an agenda item that he believes enough in to implement, and bring some change for the candidate who believed in it, or at least campaigned for it.

Why do you suppose Roche didn't mention this?

"As health authorities around the world try to work out how to deal with a possible flu pandemic, an American doctor has come up with a potential solution to any drug shortage, and it's a solution that goes back more than six decades. The Oregon-based Dr Joseph Howton from the Adventist Medical Centre says using the antiviral treatment Tamiflu, together with a drug called Probenecid, makes the flu treatment last twice as long. It's a technique similar to that used during World War II to preserve supplies of penicillin."

Dr. Howton said, "Recently, I was reviewing the studies and also Tamiflu, and I found that they talk about being careful when you use Probenecid with also Tamiflu, because it raises the drug level. And I thought about it from the opposite perspective – well this is great, this a wonderful side effect, why don't we consider using Probenecid to, exactly for that reason, we have this tremendous shortage of the drug.

"And there was one study in 2002 that documented the profound effect of Probenecid on Tamiflu, it, actually it increased the level by two and a half times, and at that time it wasn't really being looked at as an issue of, you know, something to use during a shortage. But if you look at Tamiflu the same way we looked at penicillin during World War II, and penicillin was in very short supply, and as a result we gave Probenecid with penicillin to enhance the effect and extend the supplies, why not use that same idea for Tamiflu."

http://www.abc.net.au/worldtoday/content/2005/s1496227.htm

This Nobel Prize took guts

"Conventional wisdom" in the medical community has had it that most tummy ulcers are the result of stress and acidity. A whole pharmaceutical product range of anti-acid pills depended on treating the symptom, not to mention all those idiotic "executive stress" contraptions. Proving them all wrong resulted in a Nobel Prize.

The story is told well in the SMH editorial today ( http://www.smh.com.au/editorial/index.html):

"It is the archetypal science story. Researchers discover an explanation for a common ailment. They publish their findings, but so unexpected are they and so contrary to the received scientific view that they are dismissed or ignored by the medical establishment. It takes years of struggle before the findings are accepted and become medical orthodoxy. But once recognised, they open other researchers' minds to fruitful lines of investigation of similar conditions. Now the two Australian researchers have won the Nobel Prize for Physiology or Medicine.
"Doctors had believed for 50 years that the stomach was an environment so acidic that nothing could live in it. Stomach ulcers were believed to be caused by a combination of stress and acidity. Colleagues scoffed at first, and so did drug companies. The latter had built a lucrative market for expensive compounds which reduced acidity. They did not cure ulcers, but relieved their symptoms. Many sufferers would have to take them all their lives. If the doctors were right, on the other hand, the painful condition could be cured quickly with cheap antibiotics. There was thus a vested interest in maintaining the status quo. The message got through in large part due to the tenacious salesmanship of Dr Marshall, who, to prove his point, at one stage swallowed some of the bacteria and duly contracted gastritis...."

Read about this in more detail at http://www.smh.com.au/news/national/of-guts-and-glory/2005/10/04/1128191720223.html, from which came the imagery for this post.