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PO Box 3249
Oak Park, IL 60303
January 3, 2017
Honorable Judge Gershwin A. Drain
United States Federal Court Eastern District of Michigan
Theodore Levin U.S. Courthouse
231 W. Lafayette Blvd., Room 123
Detroit, MI 48226
RE: Slim Chance: 2:14-cv-13185 (E.D. Michigan 11-cv-10090)
Dear Honorable Judge Gershwin A. Drain:
You decided it was a “Slim Chance.” You own this. “Slim Chance” is the title of both the book and the movie to come. The first chapter is entitled “Gershwin A. Drain.” Because after all “silence in the face of evil is itself evil.” You envisioned too little chance for a pro se plaintiff who lost everything for speaking out and who you have never met to stand up against a seasoned firm of University of Michigan attorneys familiar to you who brazenly lied to the court. You decided that facts and evidence in this scenario were of little consequence. You denied access. You even freely and publicly planted the seed in your ruling that I may essentially be mad, “implausible,” and/or unstable. Of what purpose do facts and evidence serve, sir?
The law is dangerously weak and highly untrustworthy. And either you proved weak in its weakness, or you actually decisively protected these attorneys who you know by swiftly eliminating the possibility for facts and evidence to become a matter of public record. My attorneys lied, and by “lied” I mean they fully and deliberately intended to mislead. The human cost associated with their lies has not only been personal for me as a whistleblower, but for millions of Americans the impact remains horrific, life-altering, deadly, comprehensive, unnecessary, and criminally concealed. The price the public continues to pay is absolutely staggering, and now you own this, sir. It is on you. The domino effect of your “Slim Chance” decision has adversely altered millions of lives, giving victims virtually no chance of gaining the facts and knowledge they need to reject undergoing a very harmful and unnecessary medical procedure. Because you chose simply not to listen, you have allowed a serious human rights crime to continue and remain concealed. You denied millions of Americans protection under the U.S. Constitution. You own this profound injustice.
The tens of billions of dollars pilfered and laundered in their cloak-and-dagger conspiratorial crime spree together with hundreds of billions of healthcare dollars spent on the epidemic of entirely preventable and unnecessary deadly life-altering adverse effects intentionally caused by urologist qui tam defendants is money we have not spent on legitimate human needs for healthcare, education, infrastructure, and critical needs we have for justice in our society. Think Flint; on steroids. For the money and with the money they pilfered these defendants purchased Safe Harbor legislation within federal Anti-Kickback statutes in order to continue concealing inconceivable and intentional unnecessary harm inflicted on their patients, emblematic of those deadly human experiments performed by Josef Mengele himself.
Fortunately for me here in the United States I still have First Amendment Constitutional protection. As long as I tell the truth with the facts and evidence, I have a voice. Mine is the story of deeply corrupted U.S. legislative and (in)justice systems; I failed in my naiveté by believing that facts and evidence matter. I have now learned just how much facts and evidence do not matter to legislators and to the courts – obviously, unjustly, only money matters here. Always, without fail, follow the money. Thank you; you taught me an important lesson and now that I know better I will do better. I have learned that Constitutional protections of “life, liberty, and property,” can easily be subverted with a heedless and swift “Slim Chance” slam of the gavel. “Implausible!” “Off with her head!” Regardless of the despotic failure of our U.S. justice system, my story will be told in its entirety with your distinctly symbolic “Slim Chance” decision at its absolute center.
It is possible to kill people outright, sir, or it is entirely possible to kill them slowly, for example, by causing organ failure. Actually, one of our laws considers intentionally causing unnecessary organ failure as an act of torture. Slow long-suffering progression to organ failure is miserable and extremely costly. It is torture. It is even more horrific when it is intentionally caused by trusted doctors for no medical reason. Regardless how profoundly macabre and unscrupulous, our laws apparently support that if the money is expansive enough a physician can simply disavow deliberately causing unnecessary, slow, costly, and miserable decline in patients by concealing the secret clinical code of time and distance between cause and the effect. No one is watching. Doctors have unjustly been granted dubious rights of professional privilege to whatever it is they can claim for just about any reason to be debatable, suspicious, disputable, suspect, arguable, unclear, or “undecided.” And so these urologists have cleverly figured that rather than being truthful, forthright, and factual it overtly behooves them to deliberately conceal honest clinical information and statistics in order to make more money. No one is overseeing this; no one. They can merely agree not to formally “decide,” and not to “disclose” harmful facts and evidence for decades on end if the money is good enough. The Chairman of the University Of Michigan Department Of Urology stated his primary position was to “protect the evidence.” Always, without fail, follow the money. Their uninformed prey have a very “Slim Chance,” indeed, sir.
It was my intention as Relator in the whistleblower action to expose with facts and evidence that millions of people are unwitting pawns in easily hidden, intentional, and completely unnecessary crimes against them for the sole purpose of their urologists making tens of billions of dollars in additional “passive” income schemes. There is nothing remotely passive about these schemes, sir. They are very carefully and deliberately calculated. Frankly, many patients treated do not have kidney stones at all and their urologists are “treating” them regardless with this very dangerous life-altering “per-click” procedure simply for the money. Always, without fail, follow the money. Urologists refer their patients in droves, more often than not without any accountability or adherence to reasonable principles of safety and efficacy, to be “treated” in their own “non-provider-urologist-owned” “per click” “Fair Market Value” “side” “businesses.” It was my intent to have spelled out in specific detail how the massive malicious scheme works, and how it is spreading like wildfire. I was on the inside of it, sir, for seven years. It requires agreement and conspiracy amongst an entire class of physicians through comprehensive intentional concealment of the facts and medical evidence of harm. They understand the “law.” They know everything and are coached how to conceal their efforts. They merely claim “standard of care” as a substitute for “standard of money.” Were it not for the money, the fraudulent medical “standard of care” in this case would have been exposed and summarily rejected due to its harmful effects thirty years ago. It also requires that no one, no one oversees them with a critical eye or is held to reasonable account for their secret and totally gratuitous barbarism.
The entire medical community understands the meaning of unnecessary and intentional harm - yes, intentional, unnecessary harm; harming far more than helping. Yet, the medical community also fully comprehends how easily they are shielded from prosecution for “adverse outcomes” with virtually no legal liability for “errors” in clinical “judgement” as long as they adhere to their own phony “standards” of care. They intentionally built a sham standard, and believe in so doing they have no liability. What they have done, with facts and evidence as proof, is outrageous and horrifying. Patients trust their doctors when they are at their most vulnerable. Furthermore, they have used their patients’ money against them by purchasing legislation to conceal the disturbing scheme. They have done what the banks did to cause the crisis in 2008, only they applied the same fraudulent no-one’s-watching-so-we-can-rob-them-blind principles on a medical scale of life and death. This is not about proper medicine, sir; it is about deadly fraud.
The chances of urologists being caught in this horrific crime are reduced exponentially by having purchased legislation that permits concealment, and by building the conspiratorial cooperation of their greedy and improperly incented peers. They are harboring a grisly, macabre, powerful and threatening intent to kill people slowly by concealing the abundant fact-based knowledge of the likelihood they are causing mass unnecessary organ failure. At staggering cost in both life and treasure they are destroying kidneys and other vital organs even though there are alternative procedures that are more effective and do not cause organ failure or any of the additional horrific adverse effects. They have full awareness of far safer and more effective available treatments. Fast or slow, killing people no matter how it is done is still killing people. It is a crime whether done by deploying highly dishonest and deceptive half-truth disclaimers via patient consent, or even if it were by explicit consent of the people they are harming and killing.
They are killing people, sir, and they don’t want to get caught; it is entirely unwarranted, unnecessary, and by means of criminally fraudulent deceit because they know what they are doing and are simply concealing the truth of what they know. These urologists are placing their personal financial interests so far in front of their professional responsibilities it is beyond profoundly intentionally criminal. They are concealing material professional knowledge and outrageous corrupt intent to line their pockets. Were it not for the billions of dollars they conspired to steal joyfully and successfully from their patients and our healthcare system, this procedure would have been thoroughly abandoned thirty years ago as a harmful and dangerous, unsafe and ineffective medical “standard” of care. It is a money standard alone, sir. They are killing people, sir, and by your “Slim Chance” judgment you have condoned it. The human cost is staggering, amoral, and indefensible. It is no different than if doctors were to continue pouring mercury into wounds as antiseptic while knowing the neurotoxic adverse effects of the mercury would ultimately kill the patients, even while having full capacity to provide safe and effective antiseptics.
My attorneys lied to kill the complaint on purpose, knowing full well how much harm this would cause me. They did not care that the practices and procedures I was intending to expose are unsafe and ineffective. They had self-serving reason to lie:
1. They didn’t have time for my Complaint and they developed an obvious conflict. There are so many less challenging cases out there and it is a simply a breeze to cherry pick amidst the abundance. They were overloaded and Ms. Navarro’s professional and personal priorities were in direct conflict with the reasonable attention my Complaint required. They decided to just blow me off while knowing how dangerous this would be for me.
a. When I was contracted with them Frank, Haron, Weiner, & Navarro, PLC, the firm, was in the midst of dissolution – they provided me no information about this and I had no awareness of it.
b. I was originally guided by the Washington, D.C.-based 501c3 “Taxpayers Against Fraud” to hire Ms. Navarro and her firm.
c. Though I had no awareness of it at that time, Ms. Navarro was in the throes of becoming married to another qui tam-specialist attorney, Marc Vezina. At that time, Mr. Vezina was working on behalf of the “Taxpayers Against Fraud,” writing an amicus brief together with U.S. Attorney General Eric Holder for them when my Complaint was being investigated by the U.S. DOJ and while his wife, Navarro, was representing me.
d. At that same time, counsel for the “Taxpayers Against Fraud” included two principal attorneys; Tom Mills and John McMickle. Funny, at that time both Mills and McMickle also represented Defendants in my Complaint – “The Council for Urological Interests.”
e. The Council for Urological Interests, organized and financially supported by the Defendants in my Complaint, was responsible for legal strategy that through thinly-veiled multimillion dollar political support of Republican legislators lobbied, defended, and upheld the purchase of money-centered “business” legislation to issue a “Fair Market Value” Safe Harbor exception within the Federal Anti-Kickback laws against patient self-referral. This Safe Harbor was masterfully designed and executed by Mills and McMickle and for the sole purpose legislated to give urologists specific “per click” hefty business opportunities to defraud their patients while concealing the unsafe, ineffective, dangerous medical procedure: Urinary Extracorporeal Shockwave Lithotripsy.
f. Just prior to John McMickle representing the Council for Urological Interests he had been employed as Chief of Staff to Senator Charles Grassley, R-IA, who was then Chairman of the powerful Senate Finance Committee Subcommittee on Healthcare, overseeing the largest portion of our government’s budget. Connect the dots, sir. Connect the dollars, sir. Always, without fail, follow the money.
2. My attorneys learned about Thomas E. Zeno (and kept this from me). They read the “writing on the wall,” and clearly decided to give up on my Complaint. Thomas Zeno, U.S. Attorney in the Department of Justice suddenly-turned Defense Counsel in my Complaint was material to my Complaint but my attorneys did not tell me what was going on. So, feeling thwarted and obviously conflicted, they then lied to the court and lied to me in order to back off my complaint.
a. In February 2011 with the integral work of U.S. Attorney David Finkelstein working for the U.S. Department of Justice in Washington D.C. under direction of the Head of the Healthcare Fraud Division, Thomas E. Zeno, my Complaint and allegations began to be investigated by the FBI and OIG in Michigan.
b. The FBI was there on February 16, 2011 in Detroit when the U.S. DOJ briefly questioned me (and rather than complete the questioning left abruptly to catch their planes). They never again spoke with me during their investigation. I found that deeply troubling.
c. When Henry A. Wise III MD, a defendant in my qui tam Complaint and owner/ring leader of a band of defendants under “American Kidney Stone Management (AKSM)” from Columbus, Ohio realized that he was being investigated (all while understanding what had recently happened with the DOJ and “United Shockwave Therapies,” a so-called “competitor” of his AKSM operation), he knew there may have been a formal federal complaint filed against him “under seal.” He also had full awareness of me “the trouble maker,” explicitly: “she knows too much.” Wise was right to be fearful – I do know too much. So, he called in his favors for all the massive contributions (generated from excessive wealth he had gained over thirty years by defrauding kidney stone patients of their health and wealth) he makes to the Republican Party and “The Freedom Project.” He called in his friend fellow Ohioan, the Speaker of the United States House of Representatives: John A. Boehner. And abruptly then the next fellow Ohioan: Thomas E. Zeno – who working for the U.S. Department of Justice as Head of the Healthcare Fraud Division easily knew there had been a federal complaint filed against Wise.
d. Just for a little background here, Henry A. Wise III MD is the direct descendant of his namesake: Henry A. Wise. Yes, that Henry A. Wise. (General in the Confederate States Army, Governor of Virginia, and Delegate to the Secessionist Convention of 1861, side by side with Robert E. Lee; a zealous defender of enslaving other human beings.) So, the apple does not fall too far from the tree, as they say, sir, like a legacy for feeling fit and entitled to overtly and criminally exploit others for one’s own personal benefit. Always, without fail, follow the money.
e. Suddenly, Thomas E. Zeno retired his post at the U.S. Department of Justice (while my case was still being investigated there) and immediately went to work at Squire Sanders (now Squire Patton Boggs) as Defense Attorney for Wise and American Kidney Stone Management when the DOJ had issued them a Civil Investigative Demand. Not surprisingly by the way, after leaving his post as Speaker of the House, John Boehner also joined Zeno at Squire Patton Boggs. Cozy.
f. Zeno, who was “one of their own” from the U.S. Department of Justice, simply “made the Complaint go away” for Wise. The complaint simply vaporized. He did this nearly silently with the exception of one joyful outburst. After nearly 30 years not prosecuting heinous crimes on behalf of the American people like the one I allege, Zeno simply jumped over to corporate law graced with all the offensive advantages given him and loaded a document up with deceitful half-truths, published it on the internet proclaiming “Yes, Virginia, the Government Listens (attachment).” Hallelujah.
g. In other words, Zeno shut my complaint down and shut the government up because he knew very well how these things work. And, seriously, who then amongst them at the DOJ would want to harm one of their own and stand up against a senior U.S. attorney when he’d finally ventured out to make some real money in corporate law? The good ‘ol boys, sir; this is how the good ‘ol boys work. Just imagine how much they paid Zeno to do this.
h. My attorneys obviously knew the personal/professional consequences they would face in terms of bringing future cases to the U.S. Department of Justice if they continued to stand up for me against the DOJ and their 30-year veteran hero now suddenly in the private sector. They surely envisioned a “slim chance.” They proceeded to lie to me and to the court in order to walk away intact while preserving favor for any future cases they may bring to the U.S. DOJ. This is abundantly clear. This is how the sausage gets made, sir. This is how innocent victims are ground up in the meat-grinder to feed the abhorrent, self-serving hunger of all whose primary objective is financial exploitation. And in this case to harm and kill.
3. They have absolutely no evidence in support of their lie to the court about a “statute of limitations.” There are no supporting facts or supporting evidence to prove their lie to the court in order to damage me. They lied to walk away. They lied knowing you would never see fit to hear prosecution against them and knowing I could never find any attorney to argue malpractice against any other attorney. They saw far too many powerful players with their outstretched hands in the kidney-stone pie. They lied to protect their important relationships within the legal community and with the DOJ. They lied for the money. It did not matter that people are brutally unnecessarily harmed and dying painful costly deaths. It did not matter what duty they had to me. Even though my attorneys could have sought out building a team with other attorneys from outside their own practice in support of the Complaint, they did not. Alone, my attorneys could not bother with any perceived “slim chance.” So they threw me under the bus. And simply moved on to the next case. Easy breezy, no muss, no fuss.
The question is and always was, sir: Does the “law” support killing the innocent to shower money on the powerful? Certainly it must; your decision is the evidence! While millions of Americans have had no access to necessary medical care at all, and with no one watching, hundreds of billions of dollars have been shifted through a deadly and well-orchestrated scheme for urologists to line their pockets. And, now we have a federal administration that will support this death and fraud, because they are the ones who have been paid off.
You, sir, will ultimately have to apologize to the American people for your cardinal role in this grave injustice; this abominable and unconstitutional human rights crime.
December 22, 2018
Thomas E. Zeno
Squire Patton Boggs
2550 M St NW
Washington, DC 20037
Dear Thomas E. Zeno:
Behold the Merchants of Organ Failure: www.opensecrets.org/.../lookup2.php
Have you ever known a person willing to risk everything for the benefit of millions of other people? Believe it or not, these people actually exist. Aside from our military heroes, they are simply good people making selfless and difficult choices between right and wrong in attempt to uphold ethical and legal standards of behavior amidst the debauched desiccation of moral glue that once held society together. They actually believe in the rule of law. They actually believe in decency. They are patriots.
It is abundantly obvious that as a country we struggle in what appears to be very partisan efforts with reconciling the differences between unenforceable self-regulation of simple morality and honest behavior, and enforceable legal regulation. This infection of indecency is now a writhing spiraling battle between what some believe is an assault on “free will” by oppressive legalism, and the mitigation of monstrous selfishness and toxic greed that comes of that freedom. I discovered the irresponsible assault on common bare decency when urologists’ blood-thirsty avarice, nauseating abuse of power, and hot-headed retaliation for “paltry” Medicare reimbursements crossed the line into wholesale human rights crimes. As evidenced by your own maneuver, Dude, the decent honorable people of good will are clearly losing the war on ethics and law in our country.
Yes, Virginia. www.squirepattonboggs.com/.../yesvirginiathegovernmentlistens.pdf
As a high-ranking nearly 30-year veteran Assistant U.S. Attorney and Head of the Healthcare Fraud Division of the United States Department of Justice, you had a golden opportunity in 2010 to alleviate the suffering and death of hundreds of thousands if not millions of U.S. citizens from needless and torturous kidney failure. As a federal employee you signed up to serve the American people. So what did you and your collaborators do? Where were your dedication, accountability, and moral courage? Where was your sworn commitment to uphold our U.S. Constitution? What on earth is the point of “the law?”
Humanity has a very long history of many universal core moral values that permit us to exist at all. Two of the world’s best known moral commands against killing and stealing take but four words each to describe. They raise a standard that clearly defined leaves little room for equivocation. A Universal Declaration of Human Rights promulgated by the United Nations in 1948 was upheld again in 1975 by the Helsinki Final Act of the Conference to recognize “…the existence, in some sense, of common moral standards for judging nations and governments…” If there is in fact a moral code for contemporary life, you’d think there’d be some basic rules, such as:
1. Don’t kill.
2. Don’t cause pain.
3. Don’t disable.
4. Don’t deprive of freedom or opportunity.
5. Don’t deprive of pleasure or happiness.
As taxpayers and citizens of what once appeared to be an exemplary democracy we have trusted our Department of Justice has existed in non-partisan fashion for our protection against crime and to uphold our Constitutional rights to life, liberty, and property above all. We expect that the Department of Justice will not cower away from those criminals whose intent is to ruthlessly harm citizens and taxpayers, and whose immoral surreptitious motive to cause us harm is unmitigated greed.
With an invasive, entrenched, and ill-reputed lithotripsy scheme already long known to federal law enforcement in the U.S., on the surface it appears you approached mine as an illegitimate complaint or one that merely posed a minor ethical dilemma rather than a very serious legal matter. You simply pooh-poohed the conspiring indignant urologists’ intentional ubiquitous assault on Constitutional rights of millions of Americans. Their cagey heist from our personal and federal healthcare coffers, regardless of full awareness of the life-threatening damage they have always known they were unnecessarily inflicting on their victims, was their unwavering motive. Amassing power in both numbers and dollars, they fully engaged Republican legislators including Senator Chuck Grassley in their deliberately hidden-in-plain-sight effort. Did you really not see this? What was YOUR intent? What was YOUR motive? Did you find it easier to just join in and drink the Kool-Aid? What planet are you living on? Who are you trying to fool, dude? Was it a “mistake…”- just a “mistake” resulting in a colossal nauseating heap of unnecessary suffering, injury, and death to innumerable Americans? What burns me most is how audaciously you spiked the ball the first moment after abusing your own power to get my complaint dismissed: Yes, Virginia. The moment my attorneys discovered your “Defector” maneuver, they just gave up. I will never give up; no matter what.
The facts demonstrate that in the couple of months following your big winning touchdown for Wise, et al, I began methodically revealing what you people at the US DOJ refused to reveal in public. In short order, Rubenstein and Norris, Wheelock, Wise, Madsen, and all the others began immediate efforts to unload their sociopathic fraud-laden enterprises like hot potatoes to vampire hedge funds and disgraceful drunken private equity groups. They suddenly feared their crime jig was up. For decades they’d counted on the “law” (the “FMV” Safe Harbor they’d purchased in the Anti-kickback Statute) to reward their duplicity (rather than honest and sound medical judgment) and open up a freeway to their greed. They grabbed as much moolah as fast as they could, hundreds of millions, and then scurried off into their rat holes. The Council for Urological Interests also then just sort of seemed to vaporize after what had once been a whole lot of high-profile bullshit legal hullaballoo. Dude, you bestowed a highly extravagant and deeply suspicious endowment on them for their dirty dealings; for having knowledge of a serious and deadly problem and concealing it rather than warning the public. You did this.
The following was published in 2017 by Swiss urologists:
EXTRACORPOREAL SHOCK-WAVE LITHOTRIPSY (ESWL)
FOR RENAL STONES IS ASSOCIATED WITH DECREASED
KIDNEY FUNCTION AFTER LONG TERM FOLLOW-UP
Christian Fankhauser*, Josias Grogg, Alexander Holenstein,
Qing Zhong, Johann Steurer, Thomas Hermanns, Tullio Sulser,
Cedric Poyet, Zurich, Switzerland
INTRODUCTION AND OBJECTIVES: Beside well character-
ized short term adverse effects of extracorporeal shock wave lithotripsy
(ESWL) for the treatment of renal stones, concerns regarding long term
adverse effects to the kidneys or adjacent organs (e.g. pancreas) were
raised. We aimed to analyze whether ESWL applied to the kidneys is
associated with decreased kidney function, hypertension or diabetes
during long term follow-up.
METHODS: All patients with urolithiasis treated by ESWL at our
tertiary care center between 1992 and 2013 were retrospectively
identified. Cases consisted of patients treated by ESWL because of
kidney stones (kidney group). Patients with distal ureter stones treated
by ESWL served as a control group. Patients treated by ESWL for
upper or middle ureter stones or patients treated for both, kidney and
distal ureter stones were excluded. In 2016, a questionnaire was sent to
all patients to assess the prevalence of decreased kidney function,
hypertension and diabetes. The Swiss Health Survey data set
(n¼ 21,597) providing population data for hypertension and diabetes but
not decreased kidney function was used as an additional comparison
RESULTS: Of 7108 identified patients, 2,776 (39%) met the
inclusion criteria. Follow-up questionnaires were returned by 764 (28%)
patients of which 585 (77%) questionnaires belonged to the kidney
group, and 179 (23%) to the distal ureter group. Median time between
first ESWL and returned questionnaire was 12 years (8-18 years) for the
kidney group and 16 years (IQR 11-20 years) for the control group.
There was no significant difference between the kidney group and the
control group regarding age (mean 62+-14 vs. 64+-14, p¼ 0.252),
gender (female 34% vs. 28%, p¼ 0.123) and BMI (mean 26+-4 vs.
26+-4, p¼ 0.687). However, in the kidney group more number of ESWL
sessions were observed compared to the control group (1 [IQR 1-2] vs.
1 [IQR 1-1], p<0.001). Furthermore the prevalence of decreased kidney
function in the kidney group was significantly higher compared to the
control group (8.3% vs. 2.9%, p¼ 0.015). The kidney group, control
group and general population showed significant differences regarding
prevalence of hypertension (47.5% vs. 49.4% vs. 27.5%, p< 0.001) and
diabetes (14.1% vs. 11.9% vs. 4.9%, p<0.001). In multivariable
regression analyses controlling for age, gender and BMI, number of
applied ESWL sessions to the kidneys was an independent predictor for
decreased kidney function (OR 1.28, 95% CI 1.010 to 1.623, p¼ 0.041)
but not for hypertension or diabetes.
CONCLUSIONS: ESWL for renal stones may lead to
decreased kidney function during long term follow-up. The association
between increasing number of applied ESWL sessions and decreased
kidney function at long-term follow-up supports a causal relationship.
Source of Funding: none.
Then there’s this:
A comprehensive new report on chronic kidney disease from the University of Virginia's Department of Public Health Sciences in Charlottesville found the condition affects nearly 14 percent of the U.S. population and costs billions in Medicare spending each year. The research which fills two massive volumes was led by Rajesh Balkrishnan, PhD, of UVA. Data in the report were provided by the United States Renal Data System.
Highlighted below are five findings from the report:
1. In 2013, Medicare spending for end-stage renal disease, or kidney failure, rose to $31 billion, not including $50 billion spent on chronic kidney disease among those 65 and older.
2. Medicare Part D patients with chronic kidney disease spent roughly $3,675 in 2013 on prescription drugs, which is 46 percent higher than prescription spending for general Medicare patients ($2,509).
3. Prescription spending for Part D patients with kidney failure was considerably higher still: At $6,673 per patient per year, spending was 2.6 times higher than general Medicare patients. Dialysis patients spent the most, at $7,142 a year.
4. Spending for Part D-covered medications for chronic kidney disease patients who received Medicare's low-income subsidy, at $6,088, was more than twice as high as those who didn't receive the subsidy, at $2,873. Patients who received the subsidy paid 1 to 20 percent in out-of-pocket costs, compared to patients who didn't receive the subsidy and paid 28 percent to 32 percent.
5. More than two-thirds (69.4 percent) of Medicare patients with chronic kidney disease and 74.2 percent of those with kidney failure were enrolled in Medicare Part D.
Urologists around the world have voiced alarm about the dangers of UESWL for decades, but have mistakenly looked to American urologists to affirm their legitimate findings. They received only silence, blank stares, and shrugged shoulders in return. Little did they know, understand, or even imagine any possible reason why American urologists would conceal their knowledge from the public: They could not know the extent to which a carefully shrouded and massive UESWL kickback scheme operated within the USA via unthinkable conspiracy. Any such scheme is completely illegal in other western countries, so it would naturally not even be a consideration. Yet, the others have remained deeply troubled and left in the dark for thirty years; until they recently began speaking out of sheer exhaustion from worry.
Subversion of a simple basic moral code of behavior has allowed American urologists to focus on anything but truth-telling about UESWL. Greed is a monster. Moral integrity requires standards of behavior to be upheld even when personal and financial ties are at stake. We license doctors to practice medicine based on this straightforward standard here in the USA. It is required that physicians make all diligent efforts to uncover and communicate all aspects of any given therapy relevant to the welfare of their patients so as to develop free and trusted communications with all parties involved. Decisions about life and death require these faithful and trusted efforts. Likewise, it is reasonable to believe that the United States Department of Justice as well will make all diligent efforts to uncover all aspects of a complaint so as to ensure free and trusted communications with all parties involved. Again, life and death require these faithful and trusted efforts.
With the American UESWL conspiracy, however, urologists would lead us, steer the conversation in fact to believe that the single most crucial aspect of this treatment is the success rate of “stone breakage.” They tout the “benefits” of that which is “non-invasive.” They do not openly discuss the measurable differences between forms of injury that could be caused by a catheter and injury that could be caused by a veritable sledge hammer. They never report on treatment success rates in general, because the effectiveness of UESWL leaves far, far too much to be desired: UESWL is mostly a failure. They instead have cultivated carefully scripted “salesmanship” of UESWL. They have nothing but a “voluntary” reporting responsibility to the FDA. They know health insurance carriers are not monitoring and could not care less how many times they repeat the procedure per patient.
Year after endless year they dishonestly fiddle around with the “stone-free rate” based on the strength and number of shocks they recommend per treatment in the medical literature – as if it even matters compared to destroying renal function in the process. They don’t reveal the number of treatments needed for “successful” stone-free rates. They rely on a faulty perception that because “all things are relative” in general they have “cover” for their calculated scheme if only they disguise it in endless “debate” and “discussion.” They have contrived this self-serving handiwork to a diabolical extent. They fully intend and firmly commit to never revealing the dramatic degree to which they are causing kidney damage to millions. They never report their many serious adverse patient events to the FDA. They are cold, calculated, have cultivated “protection,” and feel altogether and wholly entitled. Entirely unconcerned they’d never consider submitting to boring, pedestrian “Middle Class Values” like truthfulness where instead there is money to be made. They siphon our hard-earned dollars into the hands of a few at the expense of the many. With their unconscionable heist of billions of dollars they have seen the wisdom in purchasing allot of influence. Yes, Virginia, there is that.
Let’s run this down once again: In good faith I laid it all out there and came to your Justice Department with this information in 2010 after I figured it out. The years between then and now have mattered immeasurably to millions of people, Dude. The Defendants I identified are banding together, killing people, they know what they are doing, and they are concealing life-altering, harmful, and dangerous information from the patients they treat: For the money. Their crime is ongoing. Their cover-up is wildly successful. There are alternative treatments that do not cause permanent organ damage and failure. They refuse to disclose this critically relevant honest information to their patients when they are at their most vulnerable and defenseless.
Their carefully and masterfully planned conspiracy has been going on now for over thirty years. Their intentional acts against their patients’ best medical interest represent a profound breakdown and departure from what we must trust to expect in society from professional medical behavior both under standards of unenforceable self-regulation according to Hippocratic Oath and license and under defined legal standards. If it were as expected, because we seek the truth in medicine we are obliged to tell the truth. Since 2010 because of you millions of Americans have been subjected to an unnecessary threat and degree of damaged kidneys that leads to hundreds of billions of public dollars unnecessarily spent on CKD and ESRD. American urologists’ conspiracy to defraud requires they intentionally conceal life-threatening information from their patients, the general public, and from other medical professionals. Were Justice to have acted on my complaint in a reasonable manner you could have saved millions of people from death and untold suffering, and saved American taxpayers from being grievously defrauded.
Again: The Defendants deliberately conspired. The slippery slope they’ve created is horrifying. They established a code of silence with a premeditated method and process to conceal the very serious harm they knew they were doing and continue to do to their patients. They agreed together not to publish their most relevant medical findings. For thirty years they have had knowledge of the grave danger of UESWL and have failed to warn the public. They instead disguise language in patient consent forms that fosters the false belief that what in truth they know is instead unknowable. They bald-face lie. With each passing year of their continued and unchallenged deceit they become more and more confident, emboldened, and drunk with their power and success to press the boundaries of medicine beyond anything remotely reasonable for the welfare of their patients. For far too many years I was witness to all of their degenerate duplicity, and when I’d finally seen and heard enough to prove their crimes, I came forward.
I find it absolutely insane that with all your USDOJ exposure especially to Mark Rubenstein, MD (Parkside Urology, United Therapies, Council for Urological Interests, etc.) together with that of the FTC and OIG you all could not plainly see the breadth of his hostile and sociopathic madness. It took me only five minutes in Rubenstein’s presence to know there was something far more sinister going on than a “per click” “Fair Market Value” sense of financial entitlement. That guy is evil beyond anything I could ever have imagined… and then came your oh-so-self-assured buddy Sandy Wise, the bastion of Ohio Republican Corruption.
The pervasive cost of all this is obscene and extremely destructive. Those of you we trust to act according to the rule of law instead do nothing or go to the dark side. You yourself in fact actually chose to join their little death-for-money game. You became party to their barbarous scheme: Dumbfounding. How do you sleep?
You and your manly compatriots at the U.S. DOJ summarily gas-lighted me. It is so natural and easy breezy to fall into shameful and unjust institutional structural discrimination against what women bring to the table. #TimesUp, Dude. It was the easy way out; just condescend - be glibly and decisively dismissive of a woman. “What the hell would she know, anyway?” Or even worse: “She’s just in it for the money.”
That this army of conspiring urologists and Defendants is safe and unaccountable from intentional fraud, abuse, harm, and death against their patients and from defrauding our healthcare system by simply amassing political power with the money they steal is illegal. It is abhorrent and UNCONSTITUTIONAL. We expect our Justice Department to honor and uphold our laws. “The Law” stuffed a huge bale of barbed wire right up my ***. You walked off without a single thought and bee-lined it to the dark side right when my complaint was being investigated in your Department of Justice office; you now continue to swallow the ugly truth yourself. You abused your power. What the hell is wrong with you? Millions of Americans have suffered because of it. You think you could instead have done your job to uphold the Constitution?
Yes, Virginia: Your negligence and failure to act in good faith on behalf of the American public will be exposed. I will repeat myself over and over and over again in writing and will continue ad nauseum until justice is done.
Cc: lots of people
The global legal practice of Squire Sanders announced today that its legal investigations team, which included lawyers from the white collar, healthcare and litigation groups, secured a qui tam victory for client American Kidney Stone Management, Ltd. (AKSM), a leading provider of lithotripsy services throughout the US. On August 23, the Department of Justice (DOJ) and the Office of Inspector General (OIG) of the Department of Health and Human Services dismissed a complaint filed by a "whistleblower" against AKSM that alleged violations of the False Claims Act.
Prior to this dismissal, the Squire Sanders team persuasively argued that AKSM was abiding by federal healthcare and False Claims Act laws and employing industry best practices in the operation of its business.
"The dismissal of this qui tam is truly a testament to the strategy and skill of our team-work, in methodically managing this matter while embracing state-of-the-art document search technology to best present our client’s case," said Thomas E. Zeno, lead counsel of the investigations team and former federal prosecutor of nearly 30 years with DOJ in Washington, DC. "We appreciate the government's willingness to allow us to fully explain and present the facts about AKSM’s business structure, procedures and services and thus demonstrate the company's full compliance with the law."
This dismissal occurs less than one year after the government informed AKSM of its investigation. The full complaint was under seal until its dismissal to allow the government time to complete its investigation.
"We have been steadfast in our belief that our business model, operations and procedures are all in full compliance with the law," said Dr. Henry A. Wise, II, chairman and CEO of AKSM. "Although no company wants to be the subject of a government investigation, and while it was challenging to provide the government the extensive amount of documentation required, we support the government's efforts to eliminate fraud in the healthcare system. We are grateful to Squire Sanders' team that provided the guidance, strategy and expert legal counsel that secured this dismissal."
The Squire Sanders legal team included Thomas E. Zeno (white collar) from the Washington DC office, and John M. Kirsner (healthcare), Aneca E. Lasley (litigation) and Elizabeth E. Trende (healthcare) from the Columbus office.
Squire Sanders cross-practice team, with lawyers from the healthcare, white collar and litigation practices, works with clients, including boards of directors of publicly listed and privately held companies and their audit committees, across the globe and across all industries to aggressively address the complex legal and regulatory challenges, investigations and derivative claims brought by government regulators and enforcement agencies, such as the DOJ and OIG of the Department of Health and Human Services, Food and Drug Administration, among others.
Among its other businesses, AKSM is a management company that oversees the day-to-day operations of physician-owned lithotripsy companies. Lithotripsy is a medical procedure that eliminates kidney stones by smashing them with non-invasive shock waves instead of removing them through surgery. Founded in 1984 in Columbus, AKSM currently manages companies throughout the U.S.
In October 2011, the DOJ served a Civil Investigative Demand (CID) on a physician-owned lithotripsy service provider managed by AKSM. Subsequent to this CID, the government partially unsealed a complaint that revealed that AKSM and hundreds of other defendants were under investigation and alleged, among others things, that AKSM's business model was flawed and beyond the bounds of the law.
This complaint resembled other OIG investigations, one recently completed in 2010 against another provider of lithotripsy services. The result of that investigation required that company to pay US$7.3 million in Civil Monetary Penalties and enter into a five-year Corporate Integrity Agreement. That agreement settled OIG allegations that that company violated the federal Anti-Kickback laws and the Physician Self-Referral Law, known as the Stark law.
Unlike the 2010 case, the August 23 dismissal involves no payments by or Corporate Integrity Agreement with AKSM. The full complaint had been under seal until it moved to dismiss the action against AKSM and all defendants in its entirety on August 23.
The Squire Sanders investigations team responded to the complaint by distinguishing AKSM’s business management model. The team extolled AKSM’s superior, technologically advanced equipment and stringent medical quality standards, which are overseen by a corporate Medical Director. AKSM also has substantial compliance measures in place including a corporate compliance officer who establishes and maintains a Code of Conduct and develops compliance programs for the managed companies. The compliance officer also monitors, identifies and implements plans to correct problems related to these standards.
The case is United States of America ex rel. Anne E. Mitchell v. United Medical Systems, No. 2:11-cv-10090-VAR-MKM (E.D. MICH.).
Private Citizen - Whistleblower
June 3, 2019
Michigan Certificate of Need Commission and Department
C/o Michigan Department of Community Health
Certificate of Need Policy Section
South Grand Building
333 South Grand Avenue
Lansing, MI 48933
RE: UESWL Standards Review Public Comment
Dear Michigan Certificate of Need Commission and Department:
Thank you for the opportunity to provide public comment for your 2019 Review of CON Standards for Urinary Extracorporeal Shockwave Lithotripsy.
First, let’s do a little arithmetic and extrapolation:
Based on today’s published research and USRDS reporting, at your current reported performance rate, UESWL will conservatively cause Chronic Kidney Disease (CKD) needlessly in 1,600 Michigan patients per year. Because conspiring “non-provider-physician-owned” lithotripsy service providers’ carefully engineered business plans are being shielded by slick lobbying organizations like the “Council for Urological Interests (CUI)” (urologicalinterests.org ), kidney stone patients are neither clearly nor honestly made aware of medically obvious, outlandish, and deliberately concealed risks. Moreover, CKD is hardly the only known risk of UESWL – consider End Stage Renal Disease (ESRD), hemodialysis, or the exploding of a spleen, a pancreas, or renal artery. The average annual cost for treating CKD alone in an individual patient is $23,000.00.
Notwithstanding considerable suffering and premature death caused by these unchallenged UESWL “business” schemes, the cost is mind-blowing. In this light, please take stock of your own CON responsibilities to regulate quality- and cost-based access to UESWL services.
The following table represents aggregate direct costs should all patients survive and suffer for ten, twenty, and thirty years from the preconceived and otherwise needless CKD “collateral damage” in your Michigan population. No consideration is given below to those patients progressing to ESRD caused by CKD for whom cost would otherwise triple. No cost consideration is given in the following for cardiovascular damage and subsequent risks or death due to the unjustifiable CKD. Therefore, this is a very conservative estimate:
Surviving with CKD (1600 patients/year) Cost
First 10 years $8,022,400,000.00
At 20 years $56,598,400,000.00
At 30 years $174,432,000,000.00
This seems a bit predacious, don’t you think? Can we really afford to bestow the urologists’ “non-provider-physician-owned’ businesses with such a lurid little luxury? Hmmm…at year thirty we might otherwise have spent these same Michigan healthcare dollars on 872,160,000 primary care visits with emphasis on preventive medicine. Just try to render these figures on a national scale: Monstrous. It can easily be proven that UESWL is an extremely high-cost and dangerously low-value therapy.
Spending these hundreds of billions of dollars on UESWL adverse effects is entirely indefensible, because alternative methods for kidney stone removal spare the kidney. Somehow we choose to tolerate this disgraceful scandal, which is irresponsible, uncaring, and completely unacceptable.
Via their cooperative moneyed interests, urologists conspire to duplicitously distort crucial facts from their patients’ grasp. The half-truth whopper, the myth, that UESWL is advantageously “non-invasive” does not represent the whole truth that it is also precipitously harmful and manifestly lethal. Indispensable and highly consequential information is not indulged; deliberate neglect of their patients’ essential humanity and rightful, reasonable decision-making capacity to choose treatment options by taking known life-threatening facts into consideration is “standardized.” Were it not for decades-long performance of UESWL based on prioritizing personal financial interests over patient care, these hundreds of billions of dollars would be nearly ZERO. Substantial indirect costs (work-related absence, time/travel-related costs, pain and suffering, etc.) in this population are also not represented in these figures.
Intentionally neglecting to provide the necessary clinical information to make patient informed consent even possible for mitigating life-threatening risks of UESWL allows urologists to capitalize on their “non-provider-physician-owned” businesses in the cleverest way. Their victims do not even rate as “guinea pigs” in the schemes; there are deliberately no reasonable efforts undertaken to document and relate the most relevant findings about them following treatment with UESWL. Contrived patient consent forms are the insidious and evasive means of concealing known risk from patients; the truth of what has actually been observed (and yet purposely entirely absent, or inaccurately represented in the medical literature) is not discussed openly, honestly, and responsibly.
Moral integrity requires standards of behavior to be upheld even when personal and financial ties are at stake. Urologists owe their patients a duty of care: Period. We license doctors to practice medicine based on this straightforward standard here in the USA. If it were as expected, it is required that physicians make all diligent efforts to uncover and communicate all aspects of any given therapy relevant to the welfare of their patients so as to develop free and trusted communications with all parties involved. In medicine, because we seek the truth, we are obliged to tell the truth. Decisions about life and death require these faithful and trusted efforts. Urologists’ have subjugated the best medical interests of their patients now for decades in favor of their personal UESWL “business” goals. This is a consummate and sickening injustice, not borne of wasteful indulgence, but entirely of fraud and abuse.
Rather than being sold a bill-of-goods laundry list of disinformation, were all patients given crucial requisite statistical information in clear terms about the very serious risks posed them prior to deciding to undergo UESWL, they would likely think twice whether or not to choose suffering with CKD and its costly, deadly effects for the rest of their lives just so their urologist can cop an extra $1500.00 or so.
The question is this: How do you imagine that reducing by half the required number of UESWL procedures in CON provider standards from 1000 to 500/annum will affect cost, quality, and access? It would seem that access to such exorbitant danger should be more limited and surely not more widespread. How will it affect Michigan patients? Michigan employers? Michigan taxpayers? Does it even matter to MDDHS? Well, the facts do matter. It is time to go to your legislature with the facts.
I propose that your CON Standards take the distressing clinical UESWL facts into account by formulating a regulatory standard requiring explicit and extensive performance reporting related to harm and cost in a mandated registry. The cost of such a mandate in both life and treasure would be a miniscule pittance by comparison to what is now the unjustifiable standard. It is not remotely an unreasonable requirement. It would be even better if lithotripsy “business” providers were required to pay for the registry.
I also propose you create reasonable provisions that will by far more strictly limit access to UESWL in your CON Standards.
Something has got to be done, and soon. Because the FDA has abdicated reporting responsibilities for UESWL to “voluntary” status, the nauseating injustices and dangers of mendacious UESWL “business” schemes disguised as medical “standard-of-care” are far too easily swept under the rug. We simply cannot become so numb as to tolerate such an absurd paradox. It is most likely that many lives and great cost will be spared by enacting State-by-State programs where public employees and agencies of good conscience make clear and purposeful efforts to do what is right and just both clinically and financially to mitigate grave harm, injustice, and needless deadly outcomes for their residents. In the long term, this will certainly become a measure of best practice. This is one circumstance in which careful oversight is surely warranted. We are at a crossroads: I recommend you start now.
Thank you for your consideration.
July 22, 2019
MDHHS CON Commission and Department
Dear MDHHS CON Commission and Department:
Thank you for the opportunity to provide public comment for your 2019 Review of CON Standards for Urinary Extracorporeal Shockwave Lithotripsy. This public comment is intended for inclusion in your Public Hearing for Immune Effector Cell Therapy (IECT) Services, Psychiatric Beds and Services and Urinary Extracorporeal Shock Wave Lithotripsy (UEWSL) Services/Units to be held on July 25, 2019.
It is disingenuous, intellectually dishonest, and disgraceful to construe UESWL cost, quality, and access in simplistic terms of capital expense. By ignoring its true costs, your decisions about access to UESWL result in grave and deliberate harm to Michigan residents.
I have attached my public comment to you of June 3, 2019 as reference. Since 1989, UESWL has caused Chronic Kidney Disease (CKD) in more than 55,000 individuals in each year of these last thirty in the United States; 1,600 each year in Michigan. Notwithstanding the associated suffering, misery, and torment, this singular UESWL adverse effect has generated unnecessary healthcare costs nationwide topping $1.6 Trillion since then. In Michigan, this cost has neared $175 Billion. We are far smarter than this. We are far better than this. Now is the time for action; if not now, when?
It is relevant to discuss the dire importance of how these $175 Billion and $1.6 Trillion might otherwise have been spent. Rather than misusing these healthcare dollars to support dark, subversive, fraudulent and life-threatening business practices, you might otherwise have cured kidney disease. You might have prevented kidney disease with this money. Instead, the path chosen was one to grant and protect the private rights of urologists to fraudulently cast UESWL as merely a “commonly used” “industry standard.” The corruption of medical science was made possible through “Urological Interests’” conspiratorial concealment of the truth of serious harm caused by use of UESWL in order to protect kickbacks urologists and their “business partners” receive for performing the procedure.
Their carefully hatched and very secretive “non-provider-physician-owned” extortionist racketeering/patient referral schemes developed through substantial financial influence of government officials have polluted and effectively destroyed the intent of our clear anti-kickback laws against physician self-referral. These lucrative schemes have permitted urologists to create the completely false front of proper patient care while dissembling their true financial motives and destroying America’s kidney function. Extreme and entirely unnecessary cost borne of this nauseating fraud should be a sobering wake-up call for all Americans. Its example illustrates how profoundly the scourge of deceit and duplicity on our badly broken U.S. healthcare system harms us.
There are factual clear-cut reasons why we do not dependably enjoy proper healthcare in the United States. One reason is that half-truths are lies. Lies of omission are lies. Another reason is that duplicitous fraud should never be deemed “industry standard.” It is not rocket science; UESWL is obviously a public health disaster in both life and treasure. But the stakes are far too high now for offending urologists to honor the truth after all they’ve done to corrupt medicine and all they’ve neglected to do to protect their patients’ welfare over the past thirty years.
I recommend you fully utilize this characteristic UESWL debacle as an opportunity to go back to the CON drawing board. You have a dutiful obligation to act. Correctly calculating access to high-cost/ low-value medical services like UESWL requires you see through the fresh eyes of objective scientific and financial experts. Use your MDHHS epidemiologists. Invite the FDA. You may even invite physicians from outside the United States. Formulate an objective SAC that excludes the compromised, untrustworthy, unethical, unscrupulous, extortionate profiteers from the mix. Nothing about this is simple or “easy,” but it is absolutely necessary for a reliable and accountable standard to be reformulated. Please fix this. It will be well worth it.