President Trump Was Mopping Up the Healthcare Mess While Draining the Swamp

The convoluted, corrupted healthcare system inherited by the Trump administration resulted from years of flawed healthcare policy and unintended consequences that put layers of bureaucrats and corporate middlemen in between patients and their medical care. The patient–physician relationship was replaced by a government-corporate insurance complex so expensive and cumbersome that patients can’t afford it or access it. Trillions of dollars are spent sustaining a dysfunctional system of bureaucrats, middlemen, and their money games while a fraction is spent on actual patients and their care.

We must understand what blew up the healthcare system, so we won’t repeat mistakes of the past as we rebuild an honest, agile, and unencumbered system. Nothing illustrates where we are and where we must go better than these two diagrams:

Diagram One

Diagram Two

The current healthcare system consists of employer-based commercial insurance (run by corporations with government strings), Medicare (run by federal government with corporate strings), Medicaid (run by the states with federal government and corporate strings), the Veterans Administration and Military healthcare Systems (run by federal government), and the Affordable Care Act (ACA) (federal ropes, corporate cords, and state strings). Diagram one represents the Affordable Care Act (ACA) as designed and implemented by the Democrats. The entire flow chart centers on an all-powerful federal government bureaucrat. A small yellow star at the very bottom in the right corner represents American patients. A small yellow cross at the very bottom in the far left corner represents physicians. This representation says it all. Sadly, the intervening bureaucrats and middlemen are feeding and multiplying unchecked. 

In 2017 alone, U.S. insurers and providers spent more than $800 Billion on administrative costs of the current gluttonous system. That’s more than $2500 per person spent on bureaucracy and administration, not patient care- a far cry from the $2500 savings ACA cheerleaders falsely promised in 2010. On top of the $800 Billion is at least $250 Billion that goes to middlemen, such as pharmaceutical benefits managers (PBMs), who bilk the system via a supply chain corrupted by kickbacks called rebates and a massive pay-to-play scheme, under cover of secret contracts and loopholes created by flawed law. Collateral damage is increased drug costs, drug shortages, and tainted drugs to name a few. The common theme is, the money does not go to patients or their care.

The money goes to bureaucrats and middlemen. Because they have the money, they can make the decisions. If PBMs spend just 10% of their $250B annual bounty on lobbying and influencing elections, that $25 Billion swings a lot of weight influencing politicians and policy makers. They can get politicians elected who are willing play along, or they can bring them down, plugging in someone else willing to play by their rules. Imagine if this trillion dollars plus was actually spent on patients each year instead of entrenched bureaucrats, greedy middlemen, and manipulated politicians.

That brings us to Diagram Two. This is what we must build as we rise up and rebuild a sleek, personalized system 100% centered on the patient who controls the dollars and makes the decisions. No one will be left out, because the money and power flows through the patients. Yes, there will be a compassionate safety net too, funded by rerouting what is currently misused to actual care of those who need it most. Patients and families will control this safety net backstop, and there should be a role for true charity. 

This rebuild starts with a foundation built on patients, the patient-physician relationship, and free market competition. This starts with transparency. Exposing the money games will empower patients and disempower middlemen, who will have to serve patients over themselves in an ethical fashion if they want to stay in business. Because patients control the money and decision making, they will shop around for what they deem the best cost and best care. Unshackled by government and middlemen, insurance companies will create more choices that can be personalized for each patient’s needs instead of big corporate profit.

Competition for patients’ business will bring costs down. You choose your plan, you own your plan, and you get the tax benefits of your plan and healthcare expenses, just like employers do. This way no matter what happens in your life, if you change jobs, move, or suffer a medical catastrophe, you don’t lose your plan. This will decrease administrative costs and the number of patients left in a gap without insurance, exposed to the pitfall of being classified as having a “pre-existing condition.“ Best of all, if you are blessed to have a healthy year with minimal healthcare expenses, you keep your unspent money in a personalized health savings account that can grow throughout your lifetime. 

In the current system, you pay onerous premiums, end up paying out of pocket anyway, because deductibles and copays are so high, and then have nothing to show for it at year’s end. This makes the risk of going without coverage really appealing. In a new personalized system, if you don’t use the money, you keep it. Your savings from year to year will build up to a sizeable pot of money to use even as you enter Medicare age to make personal decisions about your plan, your care, and even long-term care with your dollars. As this new system progresses, if you are blessed to have money left in your account when you pass, potentially you could pass this on to your children and grandchildren for their health savings accounts. Over time, the old system will phase out under the successes of the new. Costs will come down on all aspects of your care from medications to hospitalization and surgery. Politicians will have to answer to patients not middlemen and bureaucrats.

Democrats, led by Presidential candidate former Vice-President Joe Biden and Vice-Presidential candidate Senator Kamala Harris, want to preserve the status quo and build more of the same on top of the collapsing foundation. Sadly, under this system premiums on the individual market have doubled, even tripled since ACA regulations took effect. Seema Verma, head of the Centers for Medicare and Medicaid Services (CMS), points out, “This means for a 60 year old couple living in Grand Island, Nebraska who earns $70,000 a year, the lowest cost silver plan would cost $38,000 a year in premiums with an $11,000 deductible…more than 2/3 of their income.” Americans can’t afford this. People are fleeing the market. Thus, the ACA created a whole new group of uninsured, and thereby, a new group of patients with pre-existing conditions; both groups are growing. The lie of  “If you like your doctor, you can keep your doctor; if you like your plan, you can keep your plan…” has been exposed in real-time. Biden wants to lower Medicare age to 60, adding millions more to the corrupted, imploding system, while Harris wants to add a public option- another elaborate government program like Diagram One- doubling down on the waste and shenanigans of bureaucrats, middlemen, and politicians.

Republicans, led by President Donald Trump and Vice President Mike Pence, want to put American patients first and at the center like Diagram Two- personalized care for you- your money, your plan, your choice. They want patients to have Better Care, More Choice, Lower Costs. They want to get rid of the administrative boondoggle and corrupt supply chains that harm patients. They want to return the trillion dollars spent on bureaucracy each year to patients and their care. They have done all they can through decreasing regulatory burden and issuing Executive orders. 

Your vote for President is critical, and so is your vote for your Senator, Representative, and state and local leaders, who will be charged with codifying each building block of the streamlined legislative structure while cleaning up the legislative rubble. Congressman Chip Roy  (TX-21) understood this healthcare crisis from the beginning and introduced both the Personalized Healthcare Act (Senator Ted Cruz has a companion bill in the Senate) and Healthcare Freedom Act. Both facilitate transition from Diagram One to Diagram Two; both are waiting on terminal hold for Speaker Nancy Pelosi to bring them up for a vote. We must vote for leaders who will fight against bureaucrats, middlemen, and politicians and who will fight for us to have control of our medical decisions and dollars. It’s Medicare for All or Personalized Healthcare for you. Bureaucrats first or America First. President Trump has been doing this all along step by step through regulatory reform and Executive Orders, but he can’t complete the job without our votes, all the way down the ballot. He’s done so much almost single-handedly to drain the healthcare swamp. It’s time for us to help him wring the healthcare mop and finish the clean up.

Kristin S. Held, M.D.

Immediate Past President- Association of American Physicians and Surgeons

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COVID-19 Stats Betray the Facts and the American People.

The COVID-19 case counts, hospitalization numbers, and death counts are meaningless in their current form of fluid morphability. The malleability serves mainly those who seek to manipulate reality. The numbers are reported then manipulated by federal, state, county, city, and hospital authorities and agencies to name a few.  The manipulation is driven by power and money and fueled by fear mongering, panic stoking, and promise of monetary and political gain. All this is bought and paid for under the guise of trying to save the world from the COVID-19 pandemic. We must ask the appropriate questions and demand answers, which must then be verified. We must answer the question, what happened June 14-16, because something did when you look at the stats. (Did redefining what constitutes a COVID-19 case, hospitalization, or death change the numbers? Did federal financial aid to hospitals change admitting thresholds and practices? Did the FDA withdrawing its Emergency Use Authorization (EUA) for Hydroxychloroquine (HCQ) alter outpatient treatment resulting in COVID-surging? Was it the Riots? Or what?

 

Let’s look at the numbers.

 

The Council of State and Territorial Epidemiologists. (CSTE) adopted new definitions of COVID-19 cases and COVID-related deaths in April that were adopted by the Centers for Disease Control and Prevention (CDC) in May. The states were then encouraged to adopt the new definitions. The Texas Department of State Health Services (DSHS) adopted the new definitions on May 11. When were they put into effect? Which states adopted the new definitions? This makes a huge difference in the counting of New COVID-19 Cases and deaths. The May 18, 2020 Collin County Commisioners meeting is one of the best discussions of the definitions of counting I have encountered. Listen from the 15:27 to the 59 minute mark for yourself. Collin County Judge, Chris Hill, and commissioners beautifully analyzed what was about to go down and even discussed the necessity of warning Collin County residents. My city and county, San Antonio in Bexar County, adopted the new definitions and states: “COVID-19 cases include both confirmed and probable cases” on the COVID-19 San Antonio Dashboards and Data of which I screen shot a photo on July 12. The CDC/CSTE New Definition of COVID-19 cases can result in 17 probable cases from just one PCR-positive patient. COVID-related deaths can include anyone who has COVID-19 listed on their death certificate as one of the causes of death- it doesn’t have to be the first or second cause, and no COVID-19 testing is required. In the exact time frame that these new definitions would have been adopted and implemented, the new COVID cases and COVID deaths started going up in Bexar County. What is going on in your state and your county? Someone must check each of the 254 counties in Texas as well as each of the 50 states and our territories to see what definitions each is using and how their case and death counts are looking in response.

 

Why would someone want to inflate case counts, and what are the risks and benefits of doing so? As reported in Modern Healthcare,  July 17, 2020, “HHS to send $10 billion in round two of relief grants to COVID-19 hot spots.” Modern Healthcare reports, “Hospitals that had more than 161 COVID-19 admissions between January 1 and June 10 will  be paid $50,000 for each COVID-19 admission. HHS asked hospitals to start submitting COVID-19 admission data on June 8.”

Hospitals that use the new CDC definition stand to make millions of dollars. The first round of HHS grants was $12 billion and paid $76,975 per admission to hospitals that had more than 100 COVID-19 admissions from January 1 through April 1. Clearly, states hit early got tons of money- Illinois got $740 M, New York got $684 M, and Pennsylvania got $655 M alone. Additionally, Medicaid will pay out $15 billion in relief funds- hospitals must apply by August, so the more cases the better the return. Remember, this is on top of the extra money commercial insurers and the extra 20% Medicare pay the hospitals for patients hospitalized “with COVID-19.” The hospitals reporting the most cases get the most money. In addition to expanding the definition of a New COVID-19 case to include exposure to a COVID-19 positive patient and a self-reported fever, lowering admission thresholds, and requiring testing on every admission, the ability to code a hospital admission as “with-COVID” is easy and becomes a very lucrative business model. My OB-gyn colleague told me about her scheduled C-section patient who was asymptomatic but tested positive on the required admission COVID test, so she too became a hospitalization “with COVID.” The army of hospital billers and coders is no doubt hard at work scouring EMRs and community contact tracing data to find any links that could up their bounty. This may also explain why the average hospital stay for COVID-19 was now around 1.4 days last time I checked- just long enough to go beyond a 24 hour ER observation status to count as an actual hospital admission.

 

 

Now, let me be clear, the doctors, nurses, and healthcare workers do not get this money. In fact, many of my fellow physicians received up to 20% pay cuts while being asked to step up and care for the increasing number of admissions, and many nurses and other members of our healthcare teams were in fact fired or furloughed because of financial devastation resulting from the initial premature and prolonged shut downs. Hospital beds and ORs sat empty as a consequence of Governors’ Executive Orders banning  all nonurgent care. The premise was to reserve bed capacity for the anticipated COVID-19 surge. The result was near financial ruin for hospitals at the very time they were charged with preparing for a pandemic. The state governments’ bans on non-urgent care for –non-urgent cases, backfired and shot us in the foot twice. Rather than increasing capacity, Texas lost staffed hospital beds. Thus, when our COVID-19 wave came (3 months after the Governor’s EO declaring a disaster), we were less prepared, now with less staffed beds, more financial stress.  Now we have less doctors (who are over worked and under paid) and fewer nurses, teams, and staffed beds left to care for more patients. This is compounded by the new public health problem created by the bans and shutdown; all the non-COVID patients who delayed or were denied care during the near 2 month ban on treating them are all now in desperate need of care, and they are sicker. The hospitals now have more COVID patients, more non-COVID patients and less staffed beds.

 

So , yes, thank and pray for our ICU/ critical care doctors, nurses, teams, and especially patients. They are doing more with less under great stress, but they are doing phenomenally. Death rates in Texas, for example, are remarkably low in spite of the new definition of COVID-related death. As discussed earlier, being coded and a COVID-related death does not require a COVID test but does come with a big payout for the hospitals.

 

Clearly, hospitals are financially incentivized to code more COVID cases and deaths. Definitions matter. Another sad consequence is that we are losing freedoms and destroying our state and country based on the inflated numbers. Our reopenings are based on these numbers –we have lost our our ability to congregate in groups of 10 or more, go to church, school, weddings, funerals, sporting events, concerts, or go anywhere without a mask, or hug our parents, grandparents, children, grandchildren, and the lonely. In Texas, there are  Hospital Trauma Service Areas where larger counties with state and county hospitals take transfers from counties and rural hospitals less equipped. Bexar County covers for 22 counties. Our case reports did not separate out who was a Bexar County resident and who was from another county or country (and we are a 2.5 hour drive from Mexico). Ironically, while Bexar County is taking care of all the sickest patients transferred in, we are penalized because of increasing COVID-19 hospitalizations and deaths; simultaneously, the counties that sent the patients to us, record fewer COVID-19 admissions and deaths and remain open with greater freedom and liberty. San Antonio is not allowing us to gather in groups of more than 10. Meetings and events are being cancelled. Some are being rescheduled to other counties that we cover. This inflicts severe economic and psychological damage on our community.

 

This is not just a result of perverse financial incentives, but this is clearly also a political fight. San Antonio has a liberal democrat Mayor and Bexar County has a liberal democrat county judge. Their approach is totalitarian. Their goal is for democrats to win on November 3^rd. Perhaps they are willing to do whatever it takes to draw this siege out to achieve their personal political goals. Already school openings have been delayed based on their manipulated numbers. Other counties punished also have county hospitals and democrat local leaders- think Harris County and Dallas County. Look at their numbers, definitions, and  counting and reporting methods- and their loss of liberty.

 

We have done this all wrong. We must stop repeating our mistakes and instead learn from them. Imagine if the $37 billion dollars HHS is sending to hospitals now, had been spent instead hiring and training doctors, nurses, and healthcare teams, building out COVID hospitals and rehabilitation units for post-COVID care, and preparing out-patient facilities and ORs to care for non-COVID patients. And this money would have been better spent helping urgent care clinics, outpatient clinics, and rural clinics get their patients tuned up on vitamin D3, vitamin C, zinc, exercise, weight loss, control of their blood pressure, diabetes, and asthma and preparing our nursing homes and long term care facilities- including offering residents the choice of participation in outpatient studies of low dose HCQ and zinc that have proven effective when administered early in safe doses around the world,  or small doses of convalescent plasma, or other ingenious available, affordable forms of repurposed treatment and drugs like ivermectin and nebulized budesonide. Frontline healthcare workers and high risk patients could have been offered the same not-risky, potentially life-saving choices. This is inexpensive and safe. Imagine having 84% less hospital admissions to deal with now as a result. Imagine having more doctors and more staffed beds to boot. But shoulda, woulda, coulda doesn’t matter now. Let’s learn from our mistakes. Let’s demand that our numbers be meaningful not means of manipulation.

 

Finally, I haven’t even touched on the pathetic intellectual dishonesty, scientific fraud and falsification of data that has gone on to sabotage outpatient use of hydroxychloroqine and zinc in order to profit large drug and vaccine makers like Gilead that makes Remdesivir and countleothers. The trillions of dollars, billions of lives, and immeasurable conflicts of interest tying the CDC, FDA, NIH, and Fauci’s NIAID into one giant tangled web are beyond the scope of this discussion. You must research this on your own. In answer to the question, what happened June 14-16, does the rise in COVID-19 cases in any way tie back to the FDA removing the EUA for HCQ from the national stockpile for COVID-19 on June 15? False data from fake company, Surgisphere, was exposed by brave, citizen scientists and investigators resulting in retractions of articles sabotaging the use of HCQ for COVID-19. Lancet and the New England Journal of Medicine retracted two articles based on this falsified data, but not before WHO halted major studies of HCQ based on the fake science. Mathematical studies seem to suggest this has indeed contributed to increased COVID cases and death. Who bears responsibility for such evil?  Needless to say, in spite of 35 years at NIAID and over 20 billion dollars in the last 4 years alone, Fauci failed us. We were not prepared, and that was his charge. He can no longer be trusted. Former President Ronald Reagan famously said, “Trust but Verify.” I’m sorry to say, the only thing we can trust is that most of those in charge of this pandemic from Fauci on down cannot be trusted, and the critical questions must be asked by us and their answers must be pursued and verified by us. Definitions, semantics, and statistics matter. There are a few good men and women out there. It is up to We the People to identify them and help them help us. It is we who must save the world or die trying.

 

25 Questions for Texas- and Bexar County

1. Did lockdown and banning elective surgery and routine medical care stop COVID spread?
2. How many COVID cases were in Texas March 22 (when GA-09 was signed) and how many June 25 (when GA-27 was signed)?
3. Did stopping elective surgery and routine care help or hurt hospital bed availability?
4. How many HC workers were furloughed as a result of original ban on elective care?
5. How many HC workers that were furloughed, fired, or reassigned have been replaced?
6. How many licensed hospital beds are available in Texas?
7. How many staffed beds were available in March, how many were available in June?
8. How many ICU beds? How many ventilators?
9. What was hospital bed, ICU, and ventilator occupancy each of the last years over the same period of time?
10. How are cases defined? Positive PCR nasal swab tests? What is the turnaround time for results? Are antibody test results included? Are these duplicative; ie, does a single patient who has PCR positive and IgM count as 2 positive cases?
11. How many are asymptomatic from mandated testing from prisons, nursing homes, and hospital admissions for other reasons such as delivering a baby.
12. How many are symptomatic and quarantining at home?
13. How many are admitted to hospital wards?
14. What is the average length of stay? (I heard 1.4 days now)
15. What does the hospital receive for a COVID diagnosis?
16. Is there financial incentive and thus a lower threshold to admit?
17. Is there greater financial incentive to admit beyond 24 hour observation- thus explaining the 1.4 day admission average.
18. How many non-US residents are hospitalized, and what percentage of the COVID-related hospitalizations does this represent?
19. What percentage of ICU beds and ventilators do non-US residents occupy?
20. Please show a map graph showing daily testing superimposed on daily test results- include separate colored lines for total tests, positive tests, and negative tests over time (use March 1-current date).
21. Show graph showing positive tests vs. hospitalizations vs. deaths over time. (use March 1 – current date).
22. What was monthly hospital income form patient care for each of the 3 months prior to GA-09 and 3 months after?
23. What was total staff number and salary each of the 3 months prior to GA-09 and each of the 3 months after GA-09?
24. What were the staffed bed counts for each of the 3 months prior to GA-09 and each of the 3 months after GA-09.
25. Progression of reopening was going to be based on specific indicators of hospital capacity such as bed, ICU, ventilator availability. Was that based on numbers of peak bed availability before GA-09 or after? Were those numbers adjusted to honestly compare ratio?

 

Dear Texas Patients and Physicians: Here’s one thing we can do to stop the pandemic.

 

June 24, 2020

 

Dear Texas Physicians, especially primary care, urgent care and nursing home doctors,

 

When the COVID 19 pandemic hit the U.S.A., we stopped in our tracks, shut down our O.R.s, closed our clinics, and even gated our hospitals to all but urgent or emergency patients in response to Governor Abbott’s Executive Order GA-09.  At that point in time, we had very few COVID cases, hospitalizations, or deaths in Texas. We took these drastic steps to “flatten the curve.” The situation was assessed, and supplies such a PPE, ventilators, and money were shifted to areas of our county hit hardest, particularly New York City- a city like no other, that was unprepared and about to be overwhelmed.

 

According to my local San Antonio news (KENS 5 Staff (KENS 5) Published: 10:23 PMCDT March 17, 2020 Updated: 10:20 PM CDT March 30, 2020), there had been at least 212 known cases of coronavirus in Texas and five reported deaths from COVID-19 as of March 20. In stark contrast, New York Governor Andrew Cuomo issued an emergency order directing hospitals to increase their capacity by 50% as coronavirus cases across New York surged to 20,875, as of March 23, 2020. As New York’s COVID wave hit like a tsunami, ours was still barely a sprinkle, but we shut down for them and to prepare for our impending surge.

So here we are now, 3 months later, riding the Texas surge of the COVID wave, which has been purportedly “flattened” by varying orders from each of the fifty states’ Governors. We are all familiar with the intervening crises and consequences of our actions of the past 3 months. What have we learned? Will we repeat mistakes of the past, or will we use experience to save Texas lives? How will others respond and help us in return?  A lot will depend on us, and we need to step up and lead. Politicians and media have proven they are not epidemiologists, statisticians, or physicians, and even their best intentions have impeded best possible outcomes.

As physicians, we must constantly do our homework. Most of us started studying COVID 19 in January or earlier. In the interim, we have seen our ability to treat our patients and the patient relationship itself interfered with and restricted in unconstitutional ways that have harmed our patients. We have seen major scientific journals, studies, and organizations engage in intellectual dishonesty resulting in retraction of articles from Lancet and NEJM and studies being stopped and restarted worldwide based on such scientific fraud. We witnessed flawed study designs result in severely ill patients receiving toxic and potentially lethal doses of drugs. We sat by as New York kept medications from the national stockpile from being available to outpatients, hoarding and hiding behind manipulative FDA-generated restrictions, possibly driven by conflicts of interest and political motives. We watched governors send COVID-positive nursing home patients back to their nursing homes only to infect others and then die with no choice to be treated. On the other hand, we saw ingenious, boots on the ground, true physicians use what is immediately accessible to actually save lives. Dr. Robin Armstrong’s treatment of his nursing home patients and staff in Galveston, Texas stands in stark contrast to Governor Cuomo’s treatment of nursing home patients in New York. And Dr. Vladimir Zelenko’s use of hydroxychloroquine to care for his outpatients in New York stands in stark contrast to the way it was misused for inpatients on Governor Cuomo’s watch.

I fear that as more physicians have become employees, many fear retaliation, including firing, from their employer hospitals and healthcare systems, academic institutions, private equity groups, or insurance corporations. Many physicians acquiesce to unquestioningly following bureaucratic algorithms, accepting guidelines as mandates, and not innovating solutions for fear of retaliation by medical boards, threat of loss of licensure, and even threat of jail time and fines. This top down fear and intimidation leaves patients without their best advocates, their physicians- ironically, amidst a pandemic, when one would think it is our nation’s physicians we need the most.

Yet, there is hope. Half of physicians remain in private practice, subservient only to our patients and Hippocratic oath. These are the physicians patients must seek. These, like Drs. Zelenko and Armstrong, are such model physicians.

Please, fellow Texas physicians, consider treating your high risk COVID-19 patients using Dr. Zelenko’s protocol or a thoughtful individualized variation thereof. Do your homework on this. Consider treating symptomatic COVID patients early, within five days of the onset of their first symptoms, with safe, low dose hydroxychloroquine, zinc, and either azithromycin or doxycycline- before the viral load is huge, before the lungs are suffering the ravages of cytokine storm including microemboli, and before the patient deteriorates to a condition requiring hospitalization. At least offer your patients this option. Patients deserve the right to try. This will change the course of the pandemic in Texas. This is our charge, our right, and we must stand and lead.

Dear Texas Patients, as we ride out the surge of our delayed, flattened wave, be smart. If you develop symptoms, ask your urgent care or primary care doctor to prescribe you Dr. Zelenko’s protocol or their individualized variation thereof based on your individual medical status. This is not experimental. This is how doctors have practiced medicine since the beginning of time- using our years of knowledge, training, experience, and wisdom, to the best of our abilities, innovating using what we’ve got, to help you, ingeniously- while first, doing no harm. Realize, in spite of what politicians, bureaucrats, and media types tell you, we routinely write prescriptions for medications for “off-label” uses as standard of care, and as encouraged by and regarded as standard practice by the FDA. This Zelenko treatment protocol is low risk and inexpensive. You can begin it immediately. If the doctor you are seeing will not do this, find a doctor who will. You have a choice, and you must be your own best advocate at this time when many physicians are constrained by employers or other non-physician overseers, who are more interested in protecting their profits and taking no risk than in helping you. To us, your physicians, treating you is not a risk; it’s our calling. We are blessed to serve you, and honored to at least try for you.

Sincerely,

Kristin S. Held, M.D.

#Zelenko Protocol

1. Identify patients with a high risk of dying
2. Treat them within 5 days of first symptoms
3. Use a triple drug therapy

Hydroxychloroquine 200 mg twice daily for 5 days

Zinc sulfate 200 mg once daily for 5 days

Azithromycin 500 mg once a day for 5 days

“We can END the COVID 19 pandemic if we put human lives before profit and politics. Identify patients who are at high risk to die and treat them WITHIN FIVE DAYS of onset symptoms. I had a 99.7% survival rate in my patients and an 84% reduction in hospitalizations.”- Vladimir Zelenko, M.D.

 

Recipe for Disaster: Pandemic, Panic, Politicians, Patents, Patients, Physicians, Police State (Pre-publication copy)

The Association of American Physicians and Surgeons is the antidote for the alliterative poisonous “P” soup in the title.

In my last President’s Message,[1] [1] I posed the question: “Do physicians now exist who are free to serve the sick and advance the field in the tradition of our visionaries, from the perspective of intellect, curiosity, and a deep-seated desire to find a solution for each individual patient and problem? Or will a team of population-focused, algorithm-following, shift-working “mid-levels,” led by businessmen who profit from home death care, and ethics professors who hope to die at 75, command us to shut up, clock out, and send everyone to CVS with prescriptions for secobarbital or DMP2, popular aid-in dying drugs?”

When I wrote that message in January, I had heard little of COVID-19. Today in May, I have learned the answer the hard way. Little did I know that the dreaded team of population-focused, algorithm-following mid-levels, palliative care corporate profiteers, and bioethicists who specialize in rationing systems and death and dying would be upstaged by power-hungry politicians and money-hungry bureaucrats whose orders and models would stop physicians from operating, stop medications from getting to patients, and lock Americans down in our homes, sending the U.S. economy to a screeching halt and hurling our people to their knees.

Because my goal is to write a message that offers hope and a solution, writing this one has been exceedingly difficult. Today I was allowed to return to the operating room for the first time in seven weeks. Through the births of each of my four daughters, a trimalleolar fracture requiring two operations, breast cancer requiring three operations, and nearly losing a daughter after an accident that inflicted multiorgan trauma and then sepsis, I was never out of the OR for more than three weeks in my entire professional career. The blessing and privilege of being back in the clinic and OR always restores my sense of normalcy and purpose. I am thankful for the four patients who mustered up the courage to have their surgery today amid the flames of fear and panic permeating our society during this devastating SARS-CoV-2 pandemic and unprecedented response.

At this moment, when our extraordinary scientific and technological capabilities are the most advanced in human history, why are we even in this situation, what broke, and how can we fix it?

Starting at the top, when faced with the reality that a deadly contagious coronavirus was already on U.S soil, President Trump called on our federal government’s leaders in science, immunology, infectious disease, and epidemiology to direct our course of action and created a COVID-19 task force. Posing as experts on pandemic preparedness, the two dominant physician faces throughout this ordeal have been Anthony Fauci, M.D., and Deborah Birx, M.D. Dr. Fauci is an immunologist, who was appointed Director of the National Institute of Allergy and Infectious Disease (NIAID) in 1984 and has served in that capacity under six presidents. Deborah Birx, M.D., is an immunologist focused on HIV/AIDS, vaccine research, and global health, who has been with the Department of Defense since 1985, the CDC from 2005-2014, and serves as U.S. Global AIDS Coordinator and U.S. Special Representative for Global Health Diplomacy.

NIAID is one of 27 institutes that make up the National Institutes of Health (NIH). NIH and the Centers for Disease Control and Prevention (CDC) are two of the 11 agencies of the Department of Health and Human Services (HHS). Dr. Fauci and Dr. Birx are entrenched government bureaucrats, HHS relics. Each is recognized for expertise in HIV/AIDS and vaccine research. Where is that AIDS vaccine? Fauci and Birx each serve to profit personally when fruits of taxpayer-funded research and patents pay off. When was the last time either one actually examined a patient?

Despite their long tenures and lofty titles, COVID-19 seems to have caught them by surprise. In January 2017 at a conference on pandemic preparedness Fauci himself warned his audience that “there is no question that there will be a challenge to the coming Trump Administration in the arena of infectious diseases.”[2] [2] Fauci’s NIAID annual budget increased significantly from $4.9 billion in 2017 to $5.9 billion for 2020. Despite 36 years directing NIAID, tens of billions of dollars, and his own admonitions, he was not prepared, and he failed to have the U.S. prepared for this.

The Fauci-Birx emergency response has not been much better. Their epidemiological computer models grossly overestimated the projected deaths from COVID-19, particularly on Mar 16, when a report from Neil Ferguson’s team at the Imperial College London produced death estimates of 2.2 million in the U.S.[3] [3] The Washington University Institute for Health Metrics and Evaluation (IHME) model, on the other hand, projects 134,475 deaths by Aug 4, 2020, (94% fewer) and is proving to be closer to the truth, with 71,995 deaths reported by May 4, in close alignment with their prediction of 70,808–74,573.[4] [4]

“In an abundance of caution” CDC, Centers for Medicare and Medicaid Services (CMS), and other HHS agency recommendations and guidelines were generated, and an effort to “flatten the curve” commenced. The curve needed to be flattened because of New York City, one of the most densely populated cities in the world, a city that was unprepared and about to be overwhelmed. Ironically, the pandemic preparedness espoused by Fauci, a New Yorker himself, had fallen on leaders with deaf ears. All other states compassionately sacrificed to help New York through this crisis period, re-allocating and rapidly manufacturing ventilators, personal protective equipment (PPE), hospitals, medications, manpower, and money. Every state is vastly different, but all went to bat for New York as one.

Taking their cue from federal COVID-19 guidelines, individual states took action, with governors firing off executive orders increasingly influenced by partisan politics and special interests. As a Texan, I was hopeful that faced with a pandemic of epic proportion, physicians would be granted greater freedom to make best use of what we’ve got at hand to protect and treat our patients, using our years of scientific pursuit, wisdom, experience, and pattern recognition.

I am currently a plaintiff suing the State of Texas (Texas Medical Board and Texas Board of Pharmacy) to remove the ban on physician dispensing. I sincerely believed this ban would at least be temporarily removed to help patients get the physician-ordered medications they desperately needed during the COVID-19 lockdown.

One would think physicians would be regarded as friends, not foes, when facing a highly contagious lethal virus. Ironically, the Texas Medical Board (TMB) and Texas Board of Pharmacy (TBP), in out-of-control power-grabs, instead completed the conversion of federal recommendations into state edicts by creating and adopting emergency rules based on Gov. Greg Abbott’s Executive Order. The TMB and TBP emergency rules restricted physicians from operating in all but urgent or emergency cases[5] [5] and from writing prescriptions for the potentially prophylactic and therapeutic, time-tested, affordable, and available hydroxychloroquine without significant restrictions. TMB and TBP accused physicians of hoarding medications for themselves, when in fact it is the states who hoard donations of these very medications from our national stockpile.[6] [6]

The TBP gave greater freedoms to all providers associated with dispensing medications except for the physicians who actually determine what the patients need. Violation of the governor’s Executive Order replete with the TMB and TBP rules came with the prospects of 180 days in jail and a $1,000 fine, restriction or suspension of your medical license, reporting to the National Practitioner Data Bank, mandated reporting (snitching), and no due process.

TMB has aggressively pursued, and continues to pursue surgeons and physicians who dared operate on their patients or prescribe hydroxychloroquine, or perform antibody testing for their patients. Two of these are my friends. I wonder how many more there are who struggle silently, ashamed. While their patients are grateful and doing beautifully, these physicians are targeted, guilty until proven innocent, forced to turn over private patient records, and having to pay attorneys hefty fees to defend them for caring for their patients according to the Oath of Hippocrates. Young physicians who took employed positions out of residency are fired, and are now unemployed. Hospitals are going bankrupt and patients are deteriorating, going without care. The unintended consequences far outweigh the consequences of the virus itself. As federal and state restrictions are eased, we still have county, city, workplace, and intimate interpersonal barriers with which to contend.

As for me, I went to the office every day and took two weeks of 24/7 call during a period when the American Academy of Ophthalmology sent out their own set of guidelines, shaming me that I must only see emergency patients and only do emergency surgery, or I would be guilty of spreading the plague like an Anopheles mosquito or flea on a rat. There were days when I saw only two or three patients, but I was there in case my services were needed. Many of my colleagues just closed their offices. I kept all staff on the payroll, paid my overhead, and incurred debt. Like many private practice physicians, I did not take a paycheck for myself. I hope to get a Paycheck Protection Program (PPP) loan for my practice, but despite applying since day one, I have not gotten one yet.

I had paid off all my debt, but suddenly government could send me to jail if I practiced my profession, if I dared to work for a living. Now, I’m praying for a government loan, likening it to eminent domain. Never in my wildest dreams did I fathom the current state of affairs. Instead of being called upon during a pandemic as a physician and surgeon, when I should be needed most, I have been trivialized, marginalized, demonized, politicized, criminalized, weaponized, leveraged, and controlled…well, almost. Were it not for AAPS, a consortium of trusted colleagues, the worldwide access to scientific information and medical literature, my Congressman, my family, my patients, freedom-defending Americans, and the Great Physician Himself.

My hard-learned answer is, yes, we still exist, but we are an endangered species. The threat of socialized and corporate medicine is a clear and present danger, but COVID-19 has revealed that we practice medicine one decision away from bankruptcy, loss of license, and jail.

So finally, the hope and the solution: Becoming a physician requires traversing a rugged rite of passage. Not everyone has the requisites. Not everyone completes the journey. It is hard work, but hard work builds character. What is hard-earned is worth fighting for.

Those of us who made it through share those requisites and speak a shared language. We are the visionaries. We are connecting. We will fight together. We must be courageous and do what is moral and in the best interest of our patients, even if our politicians say no. AAPS has our backs, leads us, stands beside us, and holds our hands when needed. We have the scientific and technological ability to beat this virus, and together with our minds united in morality, apolitical, un-bought, and ungagged, we will find the antidote in short order.

We must fight for our right to use what we have at hand now. We must not allow an “abundance of caution” on behalf of elected leaders to morph into a lack of common sense, or worse, acquiescence to loss of civil liberties and life itself. We must develop an immunity to fear, hysteria, panic, and politics. We must continue to commune, like revolutionaries conspiring in the town tavern, against all odds until liberty or death.

We are what broke. We let them pay for our education; we let us owe them. We let them put us in networks, employ us, control us, threaten us, use us, shut us down. We let them stop us from dispensing, prescribing, operating, innovating, and thinking. We fix all this by putting minds over masks, patients over politics, freedom over fear, and God over government. And he said to them, “Doubtless you will quote to me this proverb, ‘Physician, heal yourself.’ What we have heard you did at Capernaum, do here in your hometown as well.”—Luke 4:23.

Stop selling your soul to third-party payers. They cannot do anything without you, but you can do everything without them. Denounce the AMA and the like, which profit from the implement-and-comply, billing-and-coding, testing-and-certifying industries, while lurching collectively toward single-payer socialized medicine.

Embrace AAPS, which fights “all for the patient” and for you. Finally, the naysayers who say we will never be the same again are right; we will never let this happen again. Next time we will be prepared.

Physicians such as Fauci and Birx must go, and real-life physicians with boots on the ground must replace the bureaucrats with patent-leather shoes.

 

Kristin S. Held, M.D., practices ophthalmology in San Antonio, Texas, and serves as president of AAPS.

 

REFERENCES

[1] Held KS. The cutting edge or the cliff: on which do you stand? J Am Phys Surg 2020;25:7-9.

[2] Georgetown University Medical Center. Global health experts advise planning for inevitable pandemic. GUMC Stories; Jan 12, 2017. Available at: https://gumc.georgetown.edu/gumc-stories/global-health-experts-advise-advance-planning-for-inevitable-pandemic/. Accessed May 12, 2020.

[3] Reynolds A. How one model simulated 2.2 million deaths from COVID-19. Cato at Liberty. Cato Institute; Apr 21, 2020. Available at: https://www.cato.org/blog/how-one-model-simulated-22-million-us-deaths-covid-19. Accessed May 12, 2020.

[4] Institute for Health Metrics and Evaluation. COVID-19 projections. Available at: https://covid19.healthdata.org/united-states-of-america. Accessed May 12, 2020.

[5] AAPS. ‘Don’t jail doctors for healing patients,’ Texas physicians tell Governor Abbott. Press Release; Apr 16, 2020. Available at: https://aapsonline.org/dont-jail-doctors-for-healing-patients-texas-physicians-tell-governor-abbott/. Accessed May 12, 2020.

[6] AAPS. Coronavirus victims die while government hoards medication. Press Release; May 4, 2020. Available at: https://aapsonline.org/coronavirus-victims-die-while-government-hoards-medication/. Accessed May 12, 2020.

Recommendations are Not Edicts. Texas Medical Board out of control- power grab threatens Texas patients and physicians.

April 2, 2020

 

Dear Texas Patients, Physicians, and Governor Abbott,

 

“The nine most terrifying words in the English language are: I’m from the Government, and I’m here to help.”- President Ronald Reagan August 12, 1986, News Conference.

 

Never before in U.S. history have patients and physicians faced greater danger from bad policy generated from good intentions of governments trying to help. The United States of America is a Constitutional Republic, so we must deal with multiple layers of government “help” ranging from local communities- city, district, and county councils and boards- to state and federal governments replete with their branches and respective agencies and boards. Amidst the COVID-19 pandemic and associated economic crisis, the consequences of too much governing and too much “help” are proving to be threatening for individual patients, physicians, and the future of Hippocratic medicine in the United States. One size fits all general federal recommendations are being seized upon by various entities to issue drastic orders at odds with common sense and available evidence. Federal recommendations are being construed by states as a charge to take sweeping action with no regard for differences in each of the individual states and total disregard for the concept of federalism. Idaho is very different than Illinois, and New York City is very different than San Antonio. In Texas, Loving County (population density 0 people per square mile) is very different than Harris County (population 2702 people/ square mile, 2018).

 

On March 19, 2020 I received an email from the hospital system that runs the ambulatory surgery center where I operate on my patients, informing me:

“Methodist Healthcare is committed to implementing a thoughtful approach to elective surgical cases.  On 3/18/20, CMS released new adult elective surgery and procedure recommendations.   In their guidance document, CMS recommends that in order to preserve PPE and other healthcare resources, as well as limit exposure to the COVID-19 virus, that hospitals and health systems limit non-essential surgeries and procedures.

CMS is recommending that physicians make the determination on a case by case basis if the surgery or procedure is needed urgently.”

Centers for Medicare and Medicaid Services  (CMS) is a federal agency within the United States Department of Health and Human Services. CMS released recommendations, not edicts, mandates, orders, or rules.

In response to a federal agency’s recommendations, Texas Governor Abbott issued an Executive Order GA-09 lasting through April 21,2020. The Texas Medical Board then created and adopted emergency rules on the provision of non-urgent surgeries and procedures in all licensed inpatient and outpatient facilities and medical settings. The Texas Medical Board (TMB) published a press release on March 24, 2020, TMB Passes Emergency Rules to Enforce Gov. Abbott’s Executive Order GA-09. The Texas Medical Board’s Executive Committee amended Texas law to amend the definition of “Continuing Threat to the Pubic Welfare,” to include surgeries and procedures that are “not immediately medically necessary to correct a serious medical condition of, or to preserve the life of, a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician.” Read the TMB rules for yourself as well as the Texas Medical Association’s (TMA) White Paper and FAQs pertaining to the TMB rules.

The TMB amended Texas law to facilitate temporary suspension and restriction of physicians’ licenses and require reporting to the National Practitioners Data Bank. Per the TMA’s interpretation, “The Board also amended the rule relating to peer review and hospital reporting in order to require immediate reporting rather than after the peer review process… and allow the Board to more immediately utilize the disciplinary authority granted by Texas Occupations Code, 164.059.” In response to criticism of its actions, the TMB says it cannot put physicians in jail; yet, they have created a rule of law that mandates reporting of physicians, eliminates peer review and due process, takes away physicians’ medical licenses, reports physicians to a national data bank, and can accuse and convict physicians of crimes punishable by 180 days in jail and/ or $1000 fine. Subsequently another entity, like the Attorney General, could then sentence physicians to jail. This is career and in many ways life ending for physicians who simply want to take care of their patients.

Don’t think this couldn’t happen? Here is today’s reality. A highly respected, established orthopedic surgeon, colleague and friend, informed me last night that he had just officially received a letter from the TMB investigating him for operating while the governor’s order is in effect on cases he deemed necessary. (So, this investigation has to be based on something that happened in the week spanning 3/24 and 3/31). He wanted to share with me and our surgical colleagues that the TMB “has been weaponized by this order.” He has never been sued in 16 years of practice and has never had any complaints filed with the TMB or judgments made against him. He has been head of orthopedic sports medicine at a prestigious Texas institution and with a major hospital corporation. He has been the surgeon for professional athletes and their team and has a glowing, untarnished resume. He is calling for Texas physicians to ban together to help our patients. He wrote me, “I feel like I’m in a communist country.”  One patient he operated on had a dislocated fracture and the other was a medically necessary operation in a patient who had been medically maximized for a month in order to be strong enough to undergo the medically-necessary operation, so he felt ethically obligated to proceed.  He continued, “The TMB orders and FAQs say it’s ultimately the doctor’s decision, or if it doesn’t deplete Personal Protective Equipment (PPE) it’s OK. CMS recommendations say most of what we do as orthopedic surgeons is OK and even total joint replacements are listed as category 2a, Consider Rescheduling, not you have to reschedule. This is truly crazy and dangerous.” He emphasized, “My hospitals here have had zero COVID patients and therefore no PPE issue, and as you know, we don’t use the same PPE in the OR as would be needed in the ICU for COVID patients. This rule likely requires me to violate my Hippocratic oath.”

I asked him how the TMB found out about these two cases. Did someone report him, or is the TMB collecting data on surgeons and their activities? For example, is TMB looking at CPT codes submitted by billers or received by insurance companies? He replied, “I have no idea where it started. The TMB won’t say. They don’t list any patients, just general accusations. I bet no patients understand that surgeons are being threatened and now investigated for helping them.” He has had all his patients sign special consents in this precarious time, and he has been compulsive with documentation and rule-following. He dictates and writes in the History and Physical portion of operative notes justification for proceeding with the operation including quoting from the Governor’s Executive Order. He concludes, “Our colleagues should know what TMB is doing to us.” We need to unite and rectify this situation.

Fortunately, this esteemed surgical colleague is not only allegiant to the Hippocratic oath, but he is a man of God. He left me with these words: “I’m not worried. God is in control and Jesus is on the throne. Not sure if these are the last days, but evil is called Good, and Good evil. I do think our colleagues need to know that surgeons have a target on them. Could there be some agenda to destroy doctors’ practices using this COVID crisis as justification? We need to unite and support our colleagues, targeted, as we are just trying to help our patients.”

We will get to the bottom of this, but to do so will take starting at the top. Federal bureaucratic recommendations intended to help us resulted in draconian Texas Medical Board rules that will harm physicians and patients alike. We call on Governor Abbott to call out the TMB for over-reaching on his well-intended executive order and stop these totalitarian actions being taken against Texas surgeons.

Among entities that stand to benefit from such reporting and punishment of physicians for providing care are insurance companies, who during this period of time are continuing to collect premiums and subsidies from employers, government, and individuals alike. While patients shelter in place going without care, insurers’ expenses for surgical care drastically decrease.

It will be very helpful to see where the TMB got its information to pursue investigation of this Texas physician. In the meantime, dear colleagues, stand up for your patients and yourselves. Contact your state legislators and the governor’s office to fight for your rights to practice Hippocratic medicine, and pray.

P.S. Since I started writing this piece, my colleague operated to reattach a patient’s severed limb. He left the O.R. only to find a second letter from TMB, this time more accusatory and aggressive. I bet many other surgeons have too. Time to rise up.

Open Letter to Governor Abbott- Please, let Texas doctors treat our patients. Board of Pharmacy over-reached on you Executive Order.

March 31, 2020

 

Dear Governor Abbott,

 

I wrote you last week regarding a 3^rd generation Texas pharmaceutical company that could make millions of hydroxychloroquine doses for treatment of the COVID-19 infection for Texans in short order, if the active pharmaceutical ingredient can be purchased and red tape cut. We know of a supplier in Mexico, a mere six-hour drive from the plant. I have not yet received a response. You may not have received my letter. I am sure you are aware of the findings from studies in South Korea, France, and now, New York, showing extraordinary results in patients treated with hydroxychloroquine in conjunction with zinc and often azithromycin. I just concluded an hour long discussion with physicians across the country and Vladimir Zelenko, MD, who has treated over 700 patients in his high density community of 35,000 patients in one square mile in New York, with zero deaths and only 4 patients admitted to the hospital. I implore you to instruct the Texas Board of Pharmacy to remove the restrictions on prescribing hydroxychloroquine and azithromycin. From a medical standpoint, as Dr. Zelento says, this is World Ward 3, a race between this virus and humanity, and Texas physicians need the freedom to treat our patients in ingenious, empiric, evidence-based ways. We do not have the luxury of waiting, twiddling our thumbs, rationing ventilators for a year, waiting for randomized prospective studies and a vaccine. We must act now. There is no rationale or excuse for these restrictions.

1. Hydroxychloroquine (HCQ) is safe, inexpensive, and has rare side effects. It has been used for over 60 years and used to be over the counter (OTC). It is FDA approved- just not for the precise indication of COVID-19, because this is a new virus. It is standard practice for physicians to use FDA approved drugs for off-label uses. This happens more than 20% of the time, and the FDA acknowledges this as standard of care and does not discourage off-label use. HCQ costs pennies per dose and can be taken orally, while newer biologics cost tens of thousands of dollars per treatment and must be administered intravenously. Additionally, among other antiviral and anti-inflammatory effects, HCQ inhibits the cytokine effect that causes the lethal lung damage caused by COVID-19. The science and experience exists.
2. Zinc, inexpensive and OTC, is a mineral that inhibits the COVID-19 virus from replicating, but zinc cannot enter the patient’s cells, because it is a positively charged ion. HCQ is an ionophore that opens channels allowing zinc into cells, so it can inhibit virus replication, and thus, stop damage from and spread of COVID-19.
3. Azithromycin is an inexpensive, widely used antibiotic that helps prevent secondary bacterial pneumonia and has other ancillary effects as well.
4. HCQ combined with azithromycin and Zinc, a mineral with antiviral properties, available OTC at low cost, is extremely promising.
5. India has stopped exportation of HCQ, reserving it for its own patients’ treatment, as are other countries. Israel, including Prime Minister Benjamin Netanyahu himself, Belgium, Brazil, France, and Ukraine have been in direct communication with Dr. Zelenko regarding his protocol. Prominent New York physicians and others across the country are using this protocol on out-patients who present with early symptoms with positive results, including a 90% decrease in hospital admission, eliminating the problems with shortages of hospital beds, ICUs, PPE, and ventilators. Today, the FDA approved HCQ for COVID-19, but with caveats- for New York inpatients with positive tests. The US has acquired and donated 30 million doses of HCQ from our National Strategic Stockpile to New York, and 6 million doses were donated to New York by Teva Pharmaceuticals. What about Texas? Is the US stockpile now depleted? Will other drug companies donate HCQ to Texas? We Texans are generous, kind and compassionate, but should we be equally as concerned about securing HCQ for fellow Texans as we are funneling our supplies to New York City, a city with a dangerously high population density and poor supply of hospital beds, ventilators, and personal protective equipment for front line health care workers?
6. We know that by the time the test turns positive the viral load is high. We need to start treatment earlier, to diminish spread and need for hospitalization and intubation in the scare ICU beds. On a positive note, Abbott Laboratories has developed a new rapid test that will give results in minutes instead of days. But Texas patients who fall into high risk categories- age over 60, those with chronic illness, those who are immunosuppressed or on immunosuppressive medications, and those presenting with shortness of breath- deserve the right to try this treatment that costs $20.00 with minimal side effects that decreases the problems and cost of hospitalization, shortage of PPE, ICU, intubation, and death, before the test turns positive, or they are already so sick they must be hospitalized.

This is battlefield medicine, not medicine as usual. We should not have to wait for a test to turn positive when we could begin this treatment out-patient in at-risk patients who present with symptoms. I would love to discuss this with you in detail. The science and evidence exists. I implore you to remove the restrictions you have placed on physicians and patients through the Texas Board of Pharmacy restrictions on hydroxychloroquine and azithromycin dispensing. If you will not, please, at least allow physicians to dispense these medications at cost to appropriate patients before it is too late. Physicians must not be restricted from treating our patients, and patients deserve the right to try time-tested, inexpensive, low-risk medications that empiric, evidence-based medicine is showing to be highly effective. Let Texas lead; let Texans live. The virus is so catching that half of all Americans (160,000,000) may develop the infection- some asymptomatic, some dying. Interestingly, George Washington ordered Cinchona, made from Peruvian bark containing Quinine, the predecessor of HCQ, to protect himself and his troops from malaria. The British did not have this, and many attribute the victory at Yorktown in part to Quinine-containing cinchona. Sir William Osler, MD, wrote in an 1896 edition of Journal of the American Medical Association that the discovery of cinchona is one of he greatest benefits conferred upon mankind in relation to the fevers. I can fathom no ethical reason to withhold the right for patients to try and the right for physicians to provide HCQ to Texas patients. Texas can make its own supply as the US replaces what it preferentially funneled to New York. Let’s take action, not make restrictions. Let’s keep patients out of the hospital, not shut down society and destroy the Texas economy while scrambling to build more hospitals, waiting over a year for a vaccine or expensive meds.

 

Sincerely and Prayerfully,

Kristin S. Held, M.D.

San Antonio, Texas

President, Association of American Physicians and Surgeons (AAPS)

 

P.S. AAPS General Counsel and friend Andy Schlafly sent this email to a top aide of VP Pence, Paul Teller, today, expressing what he thinks needs to be done to help patients obtain effective treatment, such as hydroxychloroquine, in the face of political forces so strongly against freedom (which is not to build new hospital beds or tell people that hundreds of thousands will inevitably die, so just get used to it). I am sharing this with you with Andy’s permission. He believes maybe people wouldn’t be in such a panic if there were not so much interference with their obtaining effective medicine, rather than being warehoused in hospital beds and told that nothing can be done for them.

 

Paul,

 

Really appreciate all your work over the years.

 

Physicians nationwide are being intimidated and prevented from prescribing, or having their prescriptions filled, for hydroxychloroquine to treat coronavirus (COVID-19).  The recent statement by the FDA is inconsequential.

 

I specialize in advising physicians and I’ve been hearing about these problems all day long.  Blue states and red states, from Maine to Virginia to Ohio to Michigan to Texas to Nevada:  physicians are being bullied away from providing effective treatment.  Some even face discipline by their medical boards on this issue, which can be a career-ender.

 

Our mortality per capita from COVID-19 is already higher than China’s, where physicians have been encouraged to prescribe hydroxychloroquine to treat the disease early there.  In India, this treatment is being used effectively as a prophylactic to protect health care workers, unlike here.  At the end of this crisis, everyone is going to bitterly complain if our per-capita numbers are much higher than China’s and India’s.

 

An Executive Order is needed immediately to prohibit interference, even by state officials, with the prescription and dispensing of hydroxychloroquine in connection with COVID-19.  Waiting until patients are hospitalized is often too late, and very costly.  Keeping people out of hospitals with early treatment is essential.

 

Thank you and please let me know if you’d like any proposed language for an Executive Order, or a signed letter about this from the Association of American Physicians & Surgeons and other medical groups.

 

Andy Schlafly

AAPS General Counsel

908-719-8608

 

AAPS Remarks to Pain Management Best Practices Inter-Agency Task Force on Final Recommendations and Dissemination by Kris Held, MD 5/10/19 “All For The Patient!”

May 10, 2019

Thank you, Dr. Singh and Members of the Best Practices Pain Management Task Force, for your work,

An opioid crisis is plaguing the U.S., and heroic measures are in place to end it. Sadly, patients and the physicians caring for them have been unfairly targeted in the war on opioids. The result? Patients in need of treatment for pain too often cannot access the care they require. Physicians striving to care for these patients not only put their careers on the line but also put themselves at some risk of prosecution and even prison.

This is why the Association of American Physicians and Surgeons (AAPS) would like to express appreciation, on behalf of our members caring for patients across the United States in the face of these challenges, for the work the Task Force has undertaken to put forward solutions. Your work is comprehensive, compassionate, and commendable.

Most importantly, we thank the Task Force for its continued emphasis that patients should come first. We are encouraged that the very first word in the final draft of the report is now, in fact, “Patients.”The emphasis on individualized patient-centered care is paramount. The report makes it clear that a complete history and physical examination are essential to best practice pain management, and “Compassionate, empathetic care centered on a patient-clinician relationship is necessary.” The Best Practices of Pain Management include an individualized, multimodal, multidisciplinary team approach.

 

You point out potential flaws of public health initiatives such as patients in the 1990’s reporting pain scores as a “Fifth Vital Sign” and, in response, physicians increasing their opioid prescribing to improve their pain scores. This warning must be heeded today by regulators who establish Merit-based Incentive Payment System (MIPS) quality measures, such as patient reported Quality ID #461: Average Change in Leg Pain Following Lumbar Discectomy and/or Laminotomy. We must learn from our mistakes, not repeat them.

 

You meaningfully recognize the danger in granting too much power to guidelines that brush aside patients’ individual circumstances. Caution is given to rigid application of guidelines such as the 2016 CDC Guidelines for prescribing opioids for chronic pain. Most doctors are so leery of the ramifications of these guidelines that they shun chronic pain patients. Misinterpretation and misapplication of government guidelines can result in patient harm, patient abandonment, and even patients turning to illicit drugs, because they cannot access the drugs they depend on to relieve their pain.

The moving, heart-felt patient testimonials included in this final draft help and presented in person at this meeting drive this point home, as do the troubling statistics revealing the crisis of suicide among pain patients.  Some patients can live a fairly normal life on opioids, but are otherwise completely disabled, even driven to despair.Pain patients lament they have been stigmatized. Sacrificing the needs of individual patients to “population health” is perhaps one of the most under-appreciated factors precipitating the current crisis.

 

In this day of medical education driven by self study and standardized testing that require robotic memorization of guidelines, a tsunami of guideline dysfunction can spiral out of control. Some states have gone so far as to enact policy based on morphed guidelines. Physicians are afraid to prescribe, and those who do have been stigmatized or worse. Pharmacists have taken it upon themselves to refuse to fill patients’ prescriptions beyond a few pills for a few days in some cases. Insurance companies, likewise, have used the guidelines as a reason to deny coverage of patients medications beyond a certain dosage or duration.

 

You shined the light on three waves of the opioid crisis to which physicians and patients are responding. Legal opioid prescriptions are now down, but overdose deaths from opioids are skyrocketing up. Why- because deadly, illicit opioids are entering the US across our borders, through points of entry, around them, and even through the US postal service; this is where resources must be emergently directed.

 

Your recommendations astutely identify third party participants in healthcare as sources of pain management interference. First, many of the drugs, opioid and non-opioid, necessary to best pain management plans are not available on hospital or insurance provider formularies. Doctors and patients should dictate the list of medications to which they need access, not Group Purchasing Organizations (GPO’s), Pharmaceutical Benefits Managers (PBMs), or other third party businesses. Further, patients must have access to each of the many modalities helpful in the best practices of pain treatment. Insurers’ delays, denials, and lack of coverage altogether must be addressed.

 

Finally, you repeatedly maintain that scientific research must be done before policies and guidelines are established. Policies must be evidence-based certainties that help patients not subjective speculations that turn out to be nothing more than failed experiments that harm patients.

 

So, how can the Association of American Physician and Surgeons help disseminate this important report to the American people?

 

AAPS was founded in 1943 to protect the sanctity of the patient-physician relationship, uphold ethical patient-centered medicine, and defend the constitutional rights of patients and physicians. Our motto “Omnia pro aegroto” means “All for the patient.”  Our members come from all states across the nation in all specialties in all forms of practice. Additionally, we have membership categories for free for patients, non-physician medical professionals, and medical students. We have active chapters in states as well. We are active with state and county medical societies and specialty societies too. We work to educate elected representatives and policy makers in DC as well as state legislators about protecting patients’ and physicians’ rights. We read the bills, rules, and laws, and provide comments and testimony. We support real solutions that restore freedom to patients and their physicians. We work to alert patients and physicians about breaking news impacting medical freedom and how they can fight back.

 

We have well-established infrastructure.

 

Our website had almost a million page views in just the last 2 months alone. It is easy to use for patients and physicians alike. A library of videos can be accessed from our YouTube channel and important information is posted daily. We have weekly media releases going to thousands of media outlets across the United States, a monthly newsletter, and a quarterly peer reviewed journal. We will disseminate this report through all these modalities. We will begin writing and publishing on the report today.

 

This year our annual meeting entitled The Heart, Soul, and Survival of American Medicinewill feature a module- “Healing the Heart and Soul of Patients in Pain and the Physicians who Care For Them”- led by Dr. Vanila Singh, Pain Management Task Force Chair, joined by Task Force member Dr. Molly Rutherford, primary care physician and addiction treatment specialist. The task force report will be presented. We will disseminate the report at our interim meetings and workshops as well.

 

We are extremely active on social media with wide reach:

 

We have 126,000 followers on Facebook, which has been a powerful tool for connecting with both doctors and especially patients. We reach many thousands more through Twitter and email.

 

We produce and disseminate pocket guides, fliers, and one-pagers.

 

We are well suited to disseminate this important information to physicians, patients, and policymakers from across the country, all specialties, and all walks of life.

 

Importantly, in addition to getting this information to patients, physicians, and medical students, we must get this information to the academic centers, hospital administrators and staffs at our hospitals, Emergency Departments, and Ambulatory Surgical Centers, Insurers, GPOs, and PBMs. We must take control of our formularies. We must disseminate this report to our pharmacists, our politicians and policy makers, our pastors and our teachers.

 

We will stand behind and defend physicians when they are mistakenly accused of wrongdoing- especially when they are doing what is best for their individual patients or if they fear retaliation from a hospital, employer, insurer, state, or federal agency.

 

AAPS brings to the table a uniquely trusted connection with grassroots advocates for patient-centered medicine that other larger groups are lacking. For instance, our email alerts are received, read, and redistributed by some of the top leaders and influencers in the physician, policy, and patient grassroots advocacy communities. We will strategically grow our pool of influencers.

 

Our media efforts get wide pickup in the heart of America, while others may focus their efforts on DC and other major metro areas and miss reaching those in “fly over states.”

We look forward to sharing this final report with those who can implement its recommendations that put patients first: our members and other medical professionals who are on the front lines of patient care. We are grateful to Dr. Singh and the Task Force for undertaking this challenging work. We look forward to future discussions about improving on and implementing solutions that align with our motto: “All for the Patient.”

Comments delivered by Kristin Story Held, M.D., President-Elect, Association of American Physicians and Surgeons, May 10, 2019, to the Pain Management Best Practices Inter-Agency Task Force in response to its Final Report during the “Roundtable Discussion on Dissemination Activities with External Stakeholders” in The Great Hall, Hubert H. Humphrey Building, 200 Independence Avenue, S. W. Washington, D.C. 20201A

Drain the Pharmaceutical Benefit Managers’ Swamp Before it Drains Us Dry

A recent patient has severe, debilitating dry eyes, but she is perfectly treated using Restasis eye drops (on the market since 2003) two times each day. Her new insurance company denied her prescription refill pending prior authorization. Her pharmacy informed her the average wholesale price for a three-month supply of the drops is $2007.72 ($8,030.88 yearly or $5.50 per drop), and she is a “covered” patient. If that doesn’t make you tear up, nothing will. Imprimus, a California pharmaceutical company, can compound these drops and mail them to her house for less than $50.00 per month (41 cents per drop). It is better for her NOT to use her insurance and pharmacy “benefits.” This nonsense must end.

Recent actions addressing escalating drug costs spark optimism. Senate Finance Committee chair Senator Chuck Grassley (R-IA) held a hearing on drug pricing in America. House Oversight Committee chair Congressman Elijah Cummings (D- MD) held a hearing on drug company price increases. Both committees, from two separate chambers of Congress led by chairmen from two separate political parties simultaneously met to address the same problems: sky-rocketing drug costs and dangerous drug shortages. Senator John Cornyn (R-TX) asked the most significant question of the panel of expert witnesses on drug pricing in America: “Can anybody on the panel explain to me why we have a general prohibition against kickbacks, call them ‘rebates,’ under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What’s the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law?”

That same heartening day, an op-ed by Health and Human Services (HHS) Secretary, “Alex Azar: Why drug prices keep going up- and why they need to come down,” https://t.co/UtoLS3zQtv appeared in STAT News showing he is committed to addressing the root cause of the problem not perpetuating a farce. February 6, the Office of the Inspector General of HHS published a proposed rule in the Federal Register that would amend the Anti-Kickback Statute that currently excludes GPOs and thus PBMs from having to comply with Anti-Kickback law.

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwjLjP7lk77gAhUK64MKHWE2CeoQFjAAegQIBBAB&url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2019%2F02%2F06%2F2019-01026%2Ffraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals&usg=AOvVaw0Hegs-7WfqDGBf0pBbSeHu  

This is encouraging, because both chambers of Congress and Executive Branch appear focused on the issue that adds 30-50% to drug costs, causes drug shortages, and enables PBMs to create drug formularies for insurers based not on what drugs doctors and patients deem best but on a complex, secret pay-to-play system of rebates (kickbacks), administrative fees, sole-source contracts, and perks. Drug makers must play to earn a preferred tier for their medications or to even get on a formulary at all.

In spite of appalling hyper-partisanship, divisiveness, and derangement on Capitol Hill, perhaps one single, one-page, bipartisan bill can be passed in Congress and signed by the President. Anyone who does not support a bill making GPOs and PBMs comply with Anti-Kickback law like everyone else is either a member of the GPO/PBM industry, uninformed, misinformed, confused, bought off, or afraid for their political, financial or physical well-being. Who sponsors the bill will be supremely telling. Who votes for the bill will be illuminating and instructive. We cannot fix healthcare unless we fix this law.

The law is the Medicare Anti-Kickback Statute (Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act) that provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs. A regulation went into effect July 29, 1991 that excluded Group Purchasing Organizations (GPOs) from the anti-kickback statute. Translation: government created an uneven playing field. Government created law then selectively enforced it. This is a license to steal. I read the final rule https://t.co/yJVI3Ift82 including government responses to comments from the proposed rule to understand how this happened. The final rule “implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.” This is a “get out of jail free card” granted to GPOs and then extended to PBMs via another act of rule and regulation shenanigans. Ironically, no financial analysis was done. HHS determined that a regulatory analysis was not required, because they certified the final rule would not have a significant impact. They did not think the rule would result in an annual effect on the economy of $100M or more, or a major increase in costs or prices for consumers, individuals, industries, Federal, State, or local government agencies, or adverse effects on competition, employment, investment, productivity, innovation, and so on. They were wrong. Of significance is a requirement that written agreements exist for HHS Secretary to inspect upon request if GPO/PBM fees exceed 3%, the customary fee in 1991 when the regulation excluding GPOs from anti-kickback law was signed. Ensuing unintended consequences of flawed law result now in nearly a quarter trillion dollars racketeered annually through this faulty, perverse drug supply chain. The Secretary of HHS, DOJ, and OIG must look into these secret contracts. I bet they have.

If the GPO exemption goes, so does the PBM’s. Three major PBMs, UnitedHealth Group, CVS Caremark, and Express Scripts, control over 80% of the PBM market and more than 70% of all prescriptions dispensed in the U.S. These three reported net revenue of $303.7 billion in 2016 alone. CVS Caremark, the largest PBM, is in process of buying Aetna, the nation’s largest health insurer. To protect $250B annual profits, net revenue, GPO/PBM supporters obfuscate and use tricky financial maneuvers in a money laundering operation, disguised as a supply chain. They do deals then change language to disguise what is actually happening. For example, a drug manufacturer offers the PBM a 40% rebate to land a good spot on the formulary of the company represented by the PBM. Don’t let them fool you when they say the rebates go 100% back to employers. What really happens in this version of legalized organized crime goes something like this: the PBM agrees to accept the drug manufacturer’s 40% rebate to put them on a formulary, but half of it (20% overall) shall be renamed “administrative fee.” While they can technically say 100% of the rebate went back to the large employer sponsor, in reality, 100% of 20% went back, while the PBM pocketed 20% that was renamed “administrative fee.” Drug makers must play or go out of business. To afford paying off PBMs, they must in turn raise drug costs in a vicious cycle that increasingly harms patients and taxpayers.

I call on both chambers of Congress and Executive Branch to act now. This is a bipartisan issue of epic proportion. Who can honestly defend this? Sadly, with $250 billion yearly at bay, many stakeholders will not only defend these practices, but they will lie insisting PBMs save money, discredit whistleblowers, work against politicians who want to fix the law, and will fund their political opponents. $250 Billion goes a long way in this regard, especially when those of us fighting them have nothing but our moral compass, knowledge of the law and its effects, and love of our patients and country.

I call on Senate Finance Committee members, Senators Grassley and Cornyn, Wyden and Warner. I call on Senior House Oversight Committee members, Elijah Cummings and Jim Jordan, to come alongside freshman members, Alexandria Octavio Cortez and Chip Roy, expose and end this now. A one-page bill is all it takes. Legislative language exists for both House and Senate.  Introduce legislation now. If you will not, then tell the American people why not.

Congress and HHS must stop pulling weeds and address the root problem. We do not want a partial fix that saves a few billion dollars that looks good on the surface but retains hundreds of billions underground for the continued organized crime spree and its players.

GPOs and PBMs: shame on you for intentionally deceiving and exploiting the American patient and fleecing the US economy.

Big insurance companies that are being acquired by, acquiring, or starting your own PBMs- you are worst of all. You take government subsidies, the people’s money, and money directly from people and their employers. Instead of working for the good of the people by refusing to play the game and exposing the cartel, you join in, taking kickbacks and individual perks.

This must end. Drug costs will plummet and drug shortages will disappear in short order. Wake up America! Save the patients and the people not the PBMs and their dysfunctional “healthcare system” that are draining us dry.

Drain the PBM Swamp Before It Drains Us Dry

A recent patient has severe, debilitating dry eyes, but she is perfectly treated using Restasis eye drops, that have been on the market since 2003, two times each day. Her new insurance company denied her prescription refill pending prior authorization, and her pharmacy informed her the average wholesale price for a three-month supply of the drops is $2007.72 ($8,030.88 yearly or $5.50 per drop), and she is a “covered” patient. If that doesn’t make you cry, I don’t know what will. Imprimus, a California pharmaceutical company, can compound these drops and mail them to her house for less than $50.00 per month (41 cents per drop). It is better for her NOT to use her insurance and pharmacy “benefits.” Something must be done to stop this insanity.

Recent actions addressing escalating drug costs spark optimism. Senate Finance Committee chair Senator Chuck Grassley (R-IA) held a hearing on drug pricing in America. House Oversight Committee chair Congressman Elijah Cummings (D- MD) held a hearing on drug company price increases. Both committees, from two separate chambers of Congress led by chairmen from two separate political parties simultaneously met to address the same problems: sky-rocketing drug costs and dangerous drug shortages. Senator John Cornyn (R-TX) asked the most significant question of the panel of expert witnesses on drug pricing in America: “Can anybody on the panel explain to me why we have a general prohibition against kickbacks, call them ‘rebates,’ under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What’s the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law?”

That same heartening day, an op-ed by Health and Human Services (HHS) Secretary, “Alex Azar: Why drug prices keep going up- and why they need to come down,” https://t.co/UtoLS3zQtv appeared in STAT News showing he is committed to addressing the root cause of the problem not perpetuating a farce. On February 6, 2019, the Office of the Inspector General of HHS published a proposed rule in the Federal Register that would amend the Anti-Kickback Statute that currently excludes GPOs and thus PBMs from having to comply with Anti-Kickback law. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwjLjP7lk77gAhUK64MKHWE2CeoQFjAAegQIBBAB&url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2019%2F02%2F06%2F2019-01026%2Ffraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals&usg=AOvVaw0Hegs-7WfqDGBf0pBbSeHu

This is encouraging, because both chambers of Congress and the Executive Branch appear focused on the issue that adds 30-50% to drug costs, creates drug shortages, and allows PBMs to create drug formularies for insurers and employers based not on what drugs doctors and patients deem best but based on a complex, secret pay-to-play system of rebates (kickbacks), administrative fees, sole-source contracts, and perks drug makers must engage in to buy their medications a preferred tier or to get on a formulary at all.

In spite of appalling hyper-partisanship, divisiveness, and derangement on Capitol Hill, perhaps one single, one-page, bipartisan bill can be passed in Congress and signed by the President. Anyone who does not support a bill making GPOs and PBMs comply with Anti-Kickback law like everyone else is either a member of the GPO/PBM industry, uninformed, misinformed, confused, bought off, or afraid for their political, financial or physical well-being. Who sponsors the bill will be supremely telling. Who votes for the bill will be illuminating and instructive. We cannot fix healthcare unless we fix this law.

The law is the Medicare Anti-Kickback Statute (Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act) that provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs. A regulation went into effect July 29, 1991 that excluded Group Purchasing Organizations (GPOs) from the anti-kickback statute. Translation: government created an uneven playing field. Government created law then selectively enforced it. This is a license to steal. I read the entire final rule https://t.co/yJVI3Ift82 including all comments and government responses from the proposed rule to understand how this came to be. The final rule “implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.” This is a “get out of jail free card” granted to GPOs and then expanded to PBMs via another act of rule and regulation shenanigans. Ironically, no financial analysis was done. HHS determined that a regulatory analysis was not required, because they certified that the final rule would not have a significant impact. They did not think the rule would result in an annual effect on the economy of $100M or more, or a major increase in costs or prices for consumers, individuals, industries, Federal, State, or local government agencies, or adverse effects on competition, employment, investment, productivity, innovation, and so on. The Secretary of HHS, DOJ, and OIG can, however, look into these secret contracts upon request. They must. I bet they have.

If the GPO exemption goes, so does the PBM’s. The three major PBMs, UnitedHealth Group, CVS Caremark, and Express Scripts, alone control over 80% of the PBM market and more than 70% of all prescriptions dispensed in the U.S. These three reported net revenue of $303.7 billion in 2016 alone. CVS Caremark, the largest PBM, is in process of buying Aetna, the nation’s largest health insurer. To protect $250B annual profits, net revenue, GPO/PBM supporters obfuscate and use tricky financial maneuvers in a money laundering operation, disguised as a supply chain. They do deals then change language to disguise what is actually happening. For example, a drug manufacturer offers the PBM a 40% rebate to land a good spot on the formulary of the company represented by the PBM. Don’t let them fool you when they say the rebates go 100% back to employers. What really happens in this version of legalized organized crime goes something like this: the PBM agrees to accept the drug manufacturer’s 40% rebate to put them on a formulary, but half of it (20% overall) shall be renamed “administrative fee.” While they can technically say 100% of the rebate went back to the large employer sponsor, in reality, 100% of 20% went back, while the PBM pocketed 20% that was renamed “administrative fee.” Drug makers must play or go out of business. To afford paying off the PBMs, they must in turn raise drug costs in a vicious cycle that increasingly harms patients and taxpayers.

Of importance is a requirement that written agreements exist for HHS Secretary inspection if GPO/PBM fees exceed 3%, the customary fee in 1991 when the regulation excluding GPOs from anti-kickback law was signed. Ensuing unintended consequences of flawed law result now in nearly a quarter trillion dollars racketeered annually through this faulty, perverse drug supply chain.

I call on both chambers of Congress and the Executive Brach to act now. This is a bipartisan issue of epic proportion. Who can honestly defend this? Sadly, with $250 billion yearly at bay, many stakeholders will not only defend these practices, but they will lie insisting PBMs save money, discredit whistleblowers, work against politicians who want to fix the law, and will fund their political opponents. $250 Billion goes a long way in this regard, especially when those of us fighting them have nothing in our arsenal but our moral compass, knowledge of the law and its effects, and love of our patients and country.

I call on Senate Finance Committee members, Senators Grassley and Cornyn, Wyden and Warner. I call on senior House Oversight Committee members, Elijah Cummings and Jim Jordan, to come alongside freshman members Alexandria Octavio Cortez and Chip Roy, join hands, expose, and end this now. A one-page bill is all it takes. Legislative language exists for both House and Senate.  Introduce legislation now. If you will not, then tell the American people why not.

Congress and HHS must stop pulling weeds and address the root problem. We do not want a partial fix that saves a few billion dollars that looks good on the surface but retains hundreds of billions underground for the continued organized crime spree and its players.

GPOs and PBMs: shame on you, for intentionally deceiving and exploiting the American patient and fleecing the US economy.

Big insurance companies that are being acquired by, acquiring, or starting your own PBMs: you are worst of all. You take government subsidies, the people’s money, and money directly from people and their employers. Instead of working for the good of the people by refusing to play the game and exposing the cartel, you join in, taking kickbacks and individual perks.

This must end. Drug costs will plummet and drug shortages will disappear in short order. Wake up America! Save the patients and the people not the PBMs and their dysfunctional “healthcare system” that are draining us dry.