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 3rd 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.

Do Not Be Deceived! Medicare For All is Socialized Medicine, and the Democrats’ Socialist Bill has 123 Cosponsors- Americans must identify and vote against Medicare For All supporters.

Deceptively, pollsters report that “Medicare For All” is popular with Americans, as the media proclaims healthcare a top concern on voters’ minds a mere two weeks before the midterm election.  While many candidates are indeed running on a “Medicare For All” platform, few Americans realize that a Medicare for All bill actually exists and that it already has 123 Democrat cosponsors to boot. H.R.676, “The Expanded and Improved Medicare For All Act,” was introduced January 24, 2017, by former Representative John Conyers, Jr. (D-MI). Representative Keith Ellison (D-MN) assumed sponsorship when Conyers resigned after 52 years in Congress, amidst multiple allegations of sexual harassment. If Americans actually knew what was in this bill, pollsters would find rare few supporting it.

The following is a dissection of H.R.676, The Expanded & Improved Medicare For All Act, including much of the exact language as written, because it is so Orwellian socialist, that it sounds fake. But, I don’t write it; I just read it. So, here we go.

Who is eligible to be registered in the Medicare For All program?

 

  • 3   101. ELIGIBILITY AND REGISTRATION.
  • 4  (a) IN GENERAL.—All individuals residing in the
  • 5  United States (including any territory of the United
  • 6  States) are covered under the Medicare For All Program
  • 7  entitling them to a universal, best quality standard of care.
  • 8  Each such individual shall receive a card with a unique
  • 9  number in the mail. An individual’s Social Security num-
  • 10  ber shall not be used for purposes of registration under
  • 11  this section.

All individuals residing in the US, including any territory of the US, are covered under the Medicare For All program. Notice, the bill covers residents, not just citizens. The HHS Secretary is given the power to define what constitutes residency. Clearly, the political ideology of the party in the White House will impact this definition. Do you become a resident when your caravan crosses the bridge at the U.S. border? Or will there be something more to show, like a water or electricity bill?  And, each individual shall receive a card with a unique number in the mail. Just what we need, a new identifying number in addition to our Social Security number. Who knows what other uses government will devise for this new healthcare number. If the federal government handles our medical data like they do texts and emails of our politicians, the potential for malfeasance is infinite.

What entitlements will Medicare For All provide to all residents of the US and US territories (potentially everyone in the world)? The answer is seen below directly from the text of the bill. Everyone will be entitled to everything from inpatient care, outpatient care, and prescription drugs to nutritional therapy, long term care, and, of course, palliative care. Again, the presiding political philosophy will play a huge role in determining what care will be provided and for which patients (remember Ezekiel Emanuel’s Complete Lives System). The prevailing political ideology will effect the right of conscience for physicians and other clinicians.  Various levels of tolerance for various levels of procedures, as extreme as abortion and euthanasia, will swing in and out of vogue as the pendulum of societal mores, political correctness, and Godliness or Godlessness permeates the halls of Congress, White House, and Supreme Courthouse. See for yourself.

SEC. 102. BENEFITS AND PORTABILITY.
(a) In General.—The health care benefits under this Act cover all medically necessary services, including at least the following:

 

  • (1) Primary care and prevention
  • (2) Approved dietary and nutritional therapies.
  • (3) Inpatient care.
  • (4) Outpatient care.
  • (5) Emergency care.
  • (6) Prescription drugs.
  • (7) Durable medical equipment.
  • (8) Long-term care.
  • (9) Palliative care.
  • (10) Mental health services.
  • 11) The full scope of dental services, services, including periodontics, oral surgery, and endodontics, but not including cosmetic dentistry.
  • (12) Substance abuse treatment services.
  • (13) Chiropractic services, not including electrical stimulation.
  • (14) Basic vision care and vision correction (other than laser vision correction for cosmetic purposes).
  • (15) Hearing services, including coverage of hearing aids.
  • (16) Podiatric care.

 

Who will provide all the care? The defintition of “legally qualified” is unspecified and remains of concern. The government regulatory strings attached to legal qualification and licensure could be long, expensive, coercive, and destructive to physician and patient autonomy.

 

  • (b) Portability.—Such benefits are available through any licensed health care clinician anywhere in the United States that is legally qualified to provide the benefits.

 

What will each beneficiary pay? Reportedly nothing; however I could find no specific mention of premiums in the 18 pages of the bill. Currently, Medicare beneficiaries pay premiums, which are means tested. I suspect means tested premiums will eventually become part of this as socialists implement additional layers of compounded redistribution when they have to reckon with the reality that this Utopian scheme must be paid for.

 

 

  • (c) No Cost-Sharing.—No deductibles, copayments, coinsurance, or other cost-sharing shall be imposed with respect to covered benefits.

 

 

Section 104 is huge and astounding. This section makes it illegal for health insurers to sell insurance that duplicates benefits of Medicare For All. That’s it! Government completes the takeover of the entire health insurance industry in one small paragraph. Government becomes the single payer, and the transformation from free-market, patient-centered medicine to socialized medicine that serves the common good of the state is complete.

 

SEC. 104. PROHIBITION AGAINST DUPLICATING COVERAGE.

  • (a) In General.—It is unlawful for a private health insurer to sell health insurance coverage that duplicates the benefits provided under this Act.
  • (b) Construction.—Nothing in this Act shall be construed as prohibiting the sale of health insurance coverage for any additional benefits not covered by this Act, such as for cosmetic surgery or other services and items that are not medically necessary.

 

How on earth will all the elements of this monstrosity be funded? The federal government will dole out monthly lump sums to regions to cover all operating expenses. This is capitation on an unprecedented, mammoth, untested scale. Most of the government’s experience with capitation thus far has been a huge fail.

 

  • 202. PAYMENT OF PROVIDERS AND HEALTH CARE CLINICIANS.
  • (a) Establishing Global Budgets; Monthly Lump Sum.—
  • (1) IN GENERAL.—The Medicare For All Program, through its regional offices, shall pay each institutional provider of care, including hospitals, nursing homes, community or migrant health centers, home care agencies, or other institutional providers or pre-paid group practices, a monthly lump sum to cover all operating expenses under a global budget.

 

Who will be conscripted to provide all the free care to all “residents” of the U.S. and U.S. territories? Medicare For All commandeers all “Healthcare” Professionals.

 

  • (1) IN GENERAL.—The Program shall pay physicians, dentists, doctors of osteopathy, pharmacists, psychologists, chiropractors, doctors of optometry, nurse practitioners, nurse midwives, physicians’ assistants, and other advanced practice clinicians as licensed and regulated by the States by the following payment methods:
  • (A) Fee for service payment under paragraph (2).
  • (B) Salaried positions in institutions receiving global budgets under paragraph (3).
  • (C) Salaried positions within group practices or non-profit health maintenance organizations receiving capitation payments under paragraph (4).

Remember the MACRA/MIPS scoring system. This perverse system will apply here.

 

Who will decide what medications are available to you? The government will establish the drug formulary. In other words, the government will decide the list of medications from which clinicians will be able to prescribe. These may not be the best, most effective, most innovative, safest, or even cost-effective drugs, but they will no doubt be the drugs that special interests have paid-off politicians or other players in order to gain favored status. Hundreds of billions of dollars will be squandered and laundered here annually, just like is happening now with the Pharmaceutical Benefits Managers (PBMs) and Group Purchasing Organizations (GPOs) via their racketeering scheme that siphons over $200 billion annually from patients and taxpayers, inflates drug prices by 30-50%, and creates drug shortages. The government negotiations will continue to be influenced by countless special interest groups that pay to play. Conversely, if politicians refuse to play, the special interests may fund opposition candidates. The level of corruption in the swamp will skyrocket. What is best for patients will be nothing but an annoying afterthought.

 

  • 205. PAYMENT FOR PRESCRIPTION MEDICATIONS, MEDICAL SUPPLIES, AND MEDICALLY NECESSARY ASSISTIVE EQUIPMENT.
  • (a) Negotiated Prices.—The prices to be paid each year under this Act for covered pharmaceuticals, medical supplies, and medically necessary assistive equipment shall be negotiated annually by the Program.
  • (b) Prescription Drug Formulary.—
  • (1) IN GENERAL.—The Program shall establish a prescription drug formulary system, which shall encourage best-practices in prescribing and discourage the use of ineffective, dangerous, or excessively costly medications when better alternatives are available.

 

Where will the money to pay for this impracticable behemoth come from? There is not enough money for Medicare to cover its 60 million beneficiaries now. How will over 300 million more U.S. residents be covered? This part is shocking and maddening. The money does not exist, so the Medicare For All bill magically creates a new Medicare For All Trust Fund. It confiscates all money that previously went to Medicare, Medicaid, CHIP, and any other healthcare allocation and transfers it into the Trust Fund. It creates a multitude of new taxes on the American taxpayers and increases existing taxes. It then grants itself a blank check and empowers the HHS Secretary to estimate what might have been spent on all healthcare, take that amount from the US treasury, and deposit it in the Medicare For All Trust Fund.

 

 

Subtitle B—Funding

  • 211. OVERVIEW: FUNDING THE MEDICARE FOR ALL PROGRAM.
  • (a) In General.—The Medicare For All Program is to be funded as provided in subsection (c)(1).
  • (b) Medicare For All Trust Fund.—There shall be established a Medicare For All Trust Fund in which funds provided under this section are deposited and from which expenditures under this Act are made.
  • (1) IN GENERAL.—There are appropriated to the Medicare For All Trust Fund amounts sufficient to carry out this Act from the following sources:
  • (A) Existing sources of Federal Government revenues for health care.
  • (B) Increasing personal income taxes on the top 5 percent income earners.
  • (C) Instituting a modest and progressive excise tax on payroll and self-employment income.
  • (D) Instituting a modest tax on unearned income.
  • (E) Instituting a small tax on stock and bond transactions.

We must especially beware of this government blank check included in the bill. The HHS Secretary can literally estimate how much he or she thinks would have been spent on healthcare and can transfer that amount (such sums as may be necessary) directly out of the Treasury into the Medicare For All Trust Fund. No limit on this money is established. This is flagrant theft from US taxpayers.

 

  • (3) ADDITIONAL ANNUAL APPROPRIATIONS TO MEDICARE FOR ALL PROGRAM.—Additional sums are authorized to be appropriated annually as needed to maintain maximum quality, efficiency, and access under the Program.
  • 212. APPROPRIATIONS FOR EXISTING PROGRAMS.
  • Notwithstanding any other provision of law, there are hereby transferred and appropriated to carry out this Act, amounts from the Treasury equivalent to the amounts the Secretary estimates would have been appropriated and expended for Federal public health care programs, including funds that would have been appropriated under the Medicare program under title XVIII of the Social Security Act, under the Medicaid program under title XIX of such Act, and under the Children’s Health Insurance Program under title XXI of such Act.

 

If that doesn’t seem frightening enough, the scariest part is this: the Medicare For All Bill establishes the National Board of Universal Quality and Access, and not even one actual physician is guaranteed to be on it.

 

  • 305. NATIONAL BOARD OF UNIVERSAL QUALITY AND ACCESS.
  • (a) Establishment.—
  • (1) IN GENERAL.—There is established a National Board of Universal Quality and Access (in this section referred to as the “Board”) consisting of 15 members appointed by the President, by and with the advice and consent of the Senate.
  • (2) QUALIFICATIONS.—The appointed members of the Board shall include at least one of each of the following:
  • (A) Health care professionals.
  • (B) Representatives of institutional providers of health care.
  • (C) Representatives of health care advocacy groups.
  • (D) Representatives of labor unions.
  • (E) Citizen patient advocates.
  • (3) TERMS.—Each member shall be appointed for a term of 6 years, except that the President shall stagger the terms of members initially appointed so that the term of no more than 3 members expires in any year.

 

Imagine, the Board- consisting of a dietician, a long term care facility administrator, the head of Planned Parenthood, a labor union representative, and a patient advocate, plus a few others as picked by the President- making all our healthcare decisions for us. The party of Pelosi, Warren, and Waters could potentially appoint an ANTIFA member to fill the citizen patient advocate requirement. These 15 appointees will function as the arbiters of our very lives.

These unelected, government appointees, like politicized Senators and Judges wrapped into one, will decide everything from what equipment can be bought to how much a nurse will be paid and how many hours everyone can work. We just saw how well the “advice and consent of the Senate” part of the appointment process went with Judge Kavanaugh. Imagine when we are picking members of the “Life Panel.” Six year terms, with no mention of term limits, might as well be life terms. The potential for foul play and the weaponization of medicine is breathtaking.

 

  • (b) Duties.—
  • (1) IN GENERAL.—The Board shall meet at least twice per year and shall advise the Secretary and the Director on a regular basis to ensure quality, access, and affordability.
  • (2) SPECIFIC ISSUES.—The Board shall specifically address the following issues:
  • (A) Access to care.
  • (B) Quality improvement.
  • (C) Efficiency of administration.
  • (D) Adequacy of budget and funding.
  • (E) Appropriateness of reimbursement levels of physicians and other providers.
  • (F) Capital expenditure needs.
  • (G) Long-term care.
  • (H) Mental health and substance abuse services.
  • (I) Staffing levels and working conditions in health care delivery facilities.

The scope of power of these 15 government Appointed Arbiters of Americans’ lives is astounding. They literally have the power to make every single healthcare decision for every us. And when there is no money left in the US Treasury to do anything but offer “healthcare,” these 15 will allocate the scarce medical resources as they see fit. In ultimate irony, our seniors, the very Americans Medicare was created to help, will likely be the first group to de denied care- other than palliative that is.

(3) ESTABLISHMENT OF UNIVERSAL, BEST QUALITY STANDARD OF CARE.—The Board shall specifically establish a universal, best quality of standard of care with respect to—

  • (A) appropriate staffing levels;
  • (B) appropriate medical technology;
  • (C) design and scope of work in the health workplace;
  • (D) best practices; and
  • (E) salary level and working conditions of physicians, clinicians, nurses, other medical professionals, and appropriate support staff.

 

Take a moment to regroup and reckon with the possibility that Medicare For All is coming for all soon with a pricetag that will destroy the U.S. economy. In 10 years, the VA will be taken in, and the Indian Health Service Program will be taken over in just five.

 

  • TITLE IV—ADDITIONAL PROVISIONS
  • 401. TREATMENT OF VA AND IHS HEALTH PROGRAMS.
  • (a) VA Health Programs.—This Act provides for health programs of the Department of Veterans’ Affairs to initially remain independent for the 10-year period that begins on the date of the establishment of the Medicare For All Program. After such 10-year period, the Congress shall reevaluate whether such programs shall remain independent or be integrated into the Medicare For All Program.
  • (b) Indian Health Service Programs.—This Act provides for health programs of the Indian Health Service to initially remain independent for the 5-year period that begins on the date of the establishment of the Medicare For All Program, after which such programs shall be integrated into the Medicare For All Program.

 

The estimated cost of Medicare For All is $40 TRILLION over 10 years but can be reduced to $32.6 trillion if all providers’ pay is cut 40%. We will lose our highly trained medical workforce. This financial undertaking more than doubles current annual healthcare costs from inception, and we know from history that this will become exponentially more expensive as time goes on.

When will this insanity take effect? If Democrats win the House and Senate in 2 weeks, this bill could theoretically become law and take effect one year thereafter. With the Democrats’ fixation on impeachment and overt hatred of our duly elected President of the United States, the possibility is not all that far-fetched.

 

  • TITLE V—EFFECTIVE DATE
  • 501. EFFECTIVE DATE.
  • Except as otherwise specifically provided, this Act shall take effect on the first day of the first year that begins more than 1 year after the date of the enactment of this Act, and shall apply to items and services furnished on or after such date.

 

American voters must not be deceived. Medicare for All is not compassionate or good in any rational, sustainable way. Medicare For All will not solve all the problems that Medicare For Some created; it will make things tremendously worse. This Bill is an affront to the American people. No one can in good conscience cast a vote for a candidate that is running on such incompetency. Anyone running on this bill either has not read it or is a devout socialist intent on completing the fundamental transformation of the United States of America, destroying the U.S. economy, and shredding our Constitution once and for all. If we are to secure our blessings of liberty, we must identify and vote against any candidate that supports this Medicare For All bill.

 

Incompetent or Immoral- Which is it, United Healthcare?

The obstacle courses that patients and physicians must successfully navigate for physicians’ prescriptions to result in patients’ actually obtaining needed medications are becoming increasingly aggravating and dangerous. While obstacle courses are well established as part of military training for soldiers to prepare for combat and part of pop culture for contestants to compete for prizes on reality television series, the obstacle courses set up by health insurance companies serve no good purpose other than to enrich those very multi-billion dollar companies themselves and increasingly rich and powerful middlemen known as Group Purchasing Organizations (GPOs) on the inpatient side and Pharmaceutical Benefits Managers (PBMs) on the out-patient side. A misguided law with serious unintended consequences (a 1987 Medicare Anti-Kickback Safe Harbor statute that exempts these middlemen from criminal penalties for taking rebates/kickbacks from suppliers that went into effect in 1991 for GPOs) gave rise to an unimaginably corrupt pay-to-play system to let a given medication or medical device gain access to the healthcare marketplace. Translation, a medication is available at a hospital or on an insurance company’s formulary not because it is the best drug chosen by our nation’s expert physicians as having the best results and least side effects for most patients, but because the supplier of that drug has paid the most administrative fees, marketing fees, advances, conversion fees, prebates, rebates, and “sharebacks” to the GPO or PBM to pay-to-play. The drug manufacturer must then raise prices to offset the costs of the “pay-to-play.” Repeal of this flawed law would reduce cost of drugs by 30%, if not 50%, and save Medicare and Medicaid $75 billion annually. We cannot fix the healthcare mess until we shed light on the $200 billion that these middlemen take for themselves and repeal this law of unintended consequences.

 

The PBM industry is highly concentrated with just three huge companies controlling over 80% of the PBM market and more than 70% of all prescriptions dispensed in the United States. These three, UnitedHealthGroup, CVS Caremark, and Express Scripts reported aggregate net revenue of $303.7 billion in 2016 alone. The Pharmaceutical Benefits Manager for the United Healthcare, United Optum, is the largest. In 2003, PBMs petitioned the HHS OIG to extend the 1987 law covering GPOs, to cover the PBM industry. According to the Bipartisan Policy Center, from 2003 to 2013, Andy Slavitt worked at United Health Group, eventually serving as the Executive Vice President for Optum, United’s PBM middleman, which he grew to a $40 billion health services enterprise. In 2013, President Obama tapped him to repair healthcare.gov, and he then served as Acting Administrator for the Center for Medicare and Medicaid Services (CMS) from 2015-2017, executing many new programs including the significant shift to “pay-for-value” models, MACRA, and the ACA. This illustrates the incestuous nature of the PBM industry’s relationship with the federal government and explains why the middlemen are left alone with their booty as lawmakers, who rely on lobbyists’ money to get themselves reelected, turn a blind eye to anticompetitive, self-dealing business practices such as secret, sole source contracts that manipulate pricing and cause drug shortages. If just 10% of the $200 billion these middlemen bilk from our healthcare dollars through this loophole is spent lobbying, that’s a cool $20 billion they use to influence and buy favor. While politicians get re-elected and middlemen get rich, patients get gouged financially, get sicker, and needlessly die- as reported in the recent case of a young diabetic who died because he could not afford his insulin. The PBMs are to blame for a recent 300% increase in the cost of insulin. The enormous frustration I experience as a physician, is exceeded only by that I experience as a patient.

 

One month ago, a young physician mom in the last month of her residency was admitted to deliver her first baby boy. Suddenly, she sustained a complete placental abruption requiring emergency C-section and blood transfusion. Thanks to the quick, brilliant actions of the OB/Gyn, general surgeon, anesthesiologist, and labor and delivery team, both mother and baby survived this potentially fatal event. During the baby’s 16 day stay in the Neonatal Intensive Care Unit (NICU) , the astute neonatologist consulted a pediatric cardiologist, who fortunately happened to be one of 150 pediatric electrophysiologists in the country. He clinically diagnosed Congenital Long Q-T syndrome, a diagnosis that can only be confirmed by genetic testing. The hospital and insurance company balked at the physician’s order for genetic testing, which was delayed until sufficient administrative third party hurdles had been jumped. You see, physicians’ orders, including prescriptions for medications and medical devices, are now largely regarded as requests by the all-powerful hospital and insurance industries. The insurance company would not approve anything until the newborn had been entered into their system and informed the parents (who had already notified their employer, through which they got their insurance, of the birth) this could take 5-7 working days or longer. Until then, (even though in reality the baby was living in the NICU surrounded by the best doctors and nurses in Texas), the baby did not exist to the insurer, and they could make no determinations as to whether they would cover anything. The delay in diagnosis could prove fatal for the baby, who is at increased risk for sudden cardiac arrest if treated with inappropriate medications or denied protective drugs and devices. The decision was made to presumptively start the baby on protective medications and send him home with breathing monitors and an AED in case his heart stopped, pending the results of his genetic testing. The insurance company refused to cover the $1400.00 defibrillator, but fortunately, the baby’s mom was able to charge it to her credit card- knowing full well that she most likely would never be reimbursed (in spite of her onerous, monthly premiums, high copays, and huge $8500.00 family deductible.) She had spent a significant portion of medical school, internship, and residency working on prior authorizations and other obstacles to patient care thrown up by insurance companies and their PBMs. The fact that our physicians in training are used as pawns of PBMs, insurance companies and hospitals as glorified billing agents in this deadly game of delay and deny care for profit is pathetic in and of itself.

 

The mother was blessed that she and her husband could afford the defibrillator, which the insurance company refused to cover, because following hospital discharge, the results of the genetic test confirmed the diagnosis of Long QT Syndrome. Fortunately, the physicians had fought those “insurers,” who claim they must follow “process,” even if flawed. The insurance company’s business “process” includes delay and denial of care and even the ridiculous notion that the baby, who was in the NICU, did not exist for the arbitrary 5-7 day insurance company window needed to enter the baby’s data into their system. Imagine the expense of keeping the baby in the NICU even longer waiting on insurance nonsense. Imagine if a parent could not afford the defibrillator, and the baby was sent home from the NICU only to die, because the parents couldn’t afford what the doctor ordered but the insurer denied. The parents are less likely to be able to afford the $1400.00 defibrillator, because they have already handed over an exorbitant amount of money to the insurance company in the form of exorbitant monthly premiums (in addition to what the employer pays), co-pays, deductibles, and cost-sharing. We have not even factored in lost productivity for the parents and wasted resources of a neonatologist and pediatric cardiac electrophysiologist groveling for authorization for medical devices and genetic testing that determines appropriate diagnosis and treatment of the patient.

 

Once home the baby thrived but developed a tear duct infection common in infants. This condition responds beautifully to early treatment with antibiotic eye ointment but can require I.V. antibiotics and readmission to the hospital if it progresses. A person with long QT syndrome can be thrown in to sudden cardiac arrest if given improper medications that further prolong the long QT interval. The baby was accordingly prescribed Bacitracin ophthalmic ointment instead of erythromycin ophthalmic ointment, which can prolong the QT causing the heart to speed up and then stop beating. A baby’s skin is very thin and even topical medications can be absorbed into the body.

 

Bacitracin ophthalmic ointment is a drug that has been around for over 20 years and used to be very inexpensive; however, as a result of the medication middlemen and their secretive business dealings, it is now very expensive. It also did not make the cut to be listed on the United Healthcare formulary. The patient’s neighborhood pharmacy told the baby’s mother would cost $101.00 for a tiny 3.5 gram tube, and United Healthcare refused to cover it. Further insanity ensued. The United Healthcare Representative said the baby’s birthday was wrong- which it wasn’t- and that he had not met his deductible- which after 16 days in the NICU for him and 3 hospital admissions and emergency surgery for his mom, he most certainly had. The representative said he could have the erythromycin only, in spite of the pleas from the baby’s mom, a physician, who informed her the erythromycin could put the baby at risk for sudden death. This all required hours of waiting, recording, script reading, template following, transferring, holding, and discussing on the phone. The physician’s staff was simultaneously spending hours on this, as was the pharmacy. (United Optum teams up with CVS and Walgreens to the detriment of other pharmacies, and that’s another story that warrants discussion too.) So, the baby went without treatment for another 24 hours.

 

The baby’s mom tried to get access to the United formulary to see what was listed and would be covered at what tier. The representative told the mom the only way was to enter each potential drug into their website to see if it was covered, and said sending a hard copy or online copy of the formulary was not possible. The insurance was purchased through the baby’s parent’s employer who then became involved as well, as access to a formulary was pursued. The parent’s employer referred them to a MyUHC website. Not easily, the physician’s staff was able to access an online United Healthcare formulary that listed gentamicin ophthalmic ointment as tier 1, so this was then called in to the patient’s chosen pharmacy- only to be called back by the pharmacy that said there is a drug shortage and the gentamicin ophthalmic ointment is back ordered for months. Finally, another UnitedOptum formulary was found that said tobramycin drops were covered, so this was then ordered, even though it is a drop with more toxicity to the eye and not as good as an ointment for an infant in this scenario. The mom therefore decided they had worn her down, broken her, and her baby needed the medication the doctor had ordered- she would just have to go ahead and pay the $101.00 to get the best medication for the baby- and she felt blessed to once again be able to charge it on her credit card. She also grievd for all the other mom’s who could not afford to detour around the insurance obstacle course. Ironically, she could buy the Bacitracin ophthalmic ointment cheaper by not going through her insurance and using a Good Rx coupon, but this would once again require calling the physician’s office to call another prescription in to another pharmacy, and time was ticking by and serious manpower had already been squandered on patient, physician, and pharmacy ends. She could have also gotten it for less at CVS or Walgreens who have deals with United Healthcare and their PBM, OptumRx, as well- but again, more calls and delays. Finally, if point of service dispensing was legal in Texas, as it is in 44 other states, she could buy the exact medication the doctor prescribes in the doctor’s office at cost plus a couple dollars as she checks out at the front desk, administer it to the baby immediately, and forgo the run around altogether. But, is this the intent of the insurance obstacle course in the first place? Make things so difficult, that patients just give up and pay for themselves or doctors supply samples.

 

The United representative informed the baby’s mom, the case is now open, and a team is looking into covering the bacitracin since the erythromycin is contraindicated and the gentamicin is backordered, but that they have 48-72 hours to respond (and of course July 4th is in the window). The mom asked, “Do you not agree that an infection can significantly progress in a baby in 48-72 hour?” (This is a one-month-old baby, mind you.) So, she was placed on hold again, waiting to talk to an “escalation team.” The United representative returned to tell her it will take 5-7 days to get the issue resolved per the “escalation team.” So, the baby’s distraught mother asked “Does a human life matter?” Their solution was for her to pay the $100.00 then submit a claim form to try to get reimbursed retroactively. (LOL-which they will deny-and it is the mom’s responsibility to find the appropriate form and submit it to the appropriate entity.) The exhausted mother, who had just nearly died giving birth to a son she had nearly lost and now was sick in need of meds, inhaled and stated, “ So, you’re asking me to charge $101.00 on my credit card, which is an amount a lot of people can’t afford, because it takes y’all 5-7 days to resolve an issue that we know the solution for.” The representative replied, “Yes,” but you can fill out a medical claim form to try to get reimbursed.” The exasperated mom replied, “I’m a physician, so I know that you’ll deny the claim, because no one will take the time to review our case.” I ask, are you incompetent or immoral, United Healthcare?

 

I contend, the business model employed by the insurance company, its PBM, and favored pharmacies is perverse and immoral-and intentional. I contend the business model is designed to increase profit by delaying and denying care to patients. Prior authorizations, step edits, quantity limits, tiers, restricted formularies, and so on are all perverse business inventions intended to wear us out, physicians and patients, to the point we won’t finish their obstacle course. This is by design. Think about it, while small town physicians like me, my father before me, and two of my four daughters after me, endured 4 years of college, 4 years of medical school, and 4 or more years of internship and residency, sacrificing much to endure a rite of passage required of us in our pursuit of the ability to care for others as their physicians and surgeons, those in big insurance and big government like Andy Slavitt of United Optum and CMS went to Wharton Business School, got MBAs at Harvard, and worked on Wall Street in their pursuit of making money and amassing power through money. And what better commodity for them than patients’ lives?

 

Physicians work to serve our patients; insurers work to serve their stockholders. The government takes patients’ money in the form of taxes and transfers it to the insurance companies in the form of subsidies, premium support, managed are contracts, tax benefits and so on and on top of what patients and employers pay to the insurance companies as well. The insurance companies receive hundreds of billions of dollars from patients directly, from their employers, and from the government; they keep the money by delaying and denying our care. They are the de facto rationers. We are their commodity, an annoying but necessary inconvenience. All they need to do is run their numbers just right to make it look like not too many of us are dying too soon or too uncomfortably. And they must keep us quiet. Their definition of success is to best serve their stockholders. This requires least serving their patients. Keeping our money in their bank accounts even a day longer results in hundreds of millions of dollars in profit from interest alone in the long run. Each extra obstacle, each hour we linger on the phone, each day we wait for their “escalation team” to decide our fate… escalates their bottom line and our blood pressure. Think about it, when we buy our own meds, they win. When we can’t afford to buy our meds and go without, they win. When physicians tide patients over with samples and provide pro bono care, insurers win- but so do we, because that is our definition of success, serving our patients. That’s why the buck stops with us, the patients and physicians of America. The enormous frustration I experience as a physician and patient, is exceeded only by that I experience as a mother and grandmother.

 

I thank God for my amazing physician colleagues who saved the lives of my precious physician daughter and her precious baby boy, my first grandson, and I praise God for my amazing community of faith, replete with the incredible prayer warriors who prayed with us and for us without ceasing as we walked that valley. I thank God, the ultimate healer, that this community includes the most incredible, life loving, patient serving physicians, pastors, and healthcare professionals across the country who are willing to take on this scam.

 

We must shine the light on these perverse insurance business practices and processes. We must shine the light on the corrupt, racketeering PBMs. As physicians we must not be oppressed and live in fear of being fired as employees or kicked off insurance networks. We must do what’s right in our lives of service to our patients. We must become doctors again. Our patients’ lives depend on us. This will take patients and physicians refusing to run the insurance/PBM obstacle course, exposing the insurance tricks and traps, and demanding our elected representatives close the middlemen loophole that allows PBMs and GPOs to bilk us for over $200 billion per year while we experience inflated drug costs, drug shortages, poor access to drugs, and stifled innovation. While we don’t have $20 billion to lobby on Capitol Hill, we have the vote. This is not a partisan issue. This affects every single American. We must unite on this, America, all of us. Will we unite or will we continue on this never-ending immoral obstacle course- which is it America?