“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
I have often heard that those involved in our legal system have stated that a GRAND JURY is so RIGGED that they could indict a HAM SANDWICH !
according to https://en.wikipedia.org/wiki/Hippocratic_Oath It is often said that the exact phrase “First do no harm” (Latin: Primum non nocere) is a part of the original Hippocratic oath. Although the phrase does not appear in the AD 245 version of the oath, similar intentions are vowed by, “I will abstain from all intentional wrong-doing and harm”. The phrase primum non nocere is believed to date from the 17th century.
In a 1989 survey of 126 US medical schools, only three of them reported use of the original oath, while thirty-three used the Declaration of Geneva, sixty-seven used a modified Hippocratic Oath, four used the Oath of Maimonides, one used a covenant, eight used another oath, one used an unknown oath, and two did not use any kind of oath. Seven medical schools did not reply to the survey.[33]
As of 1993, only 14% of medical oaths prohibited euthanasia, and only 8% prohibited abortion.[34]
In a 2000 survey of US medical schools, all of the then extant medical schools administered some type of profession oath. Among schools of modern medicine, sixty-two of 122 used the Hippocratic Oath, or a modified version of it. The other sixty schools used the original or modified Declaration of Geneva, Oath of Maimonides, or an oath authored by students and or faculty. All nineteen osteopathic schools used the Osteopathic Oath.
Apparently this prosecutor stated to the grand jury that this prescriber violated “the law” of “to do no harm”.. which seems there is no documentation of such an exact statement in any known copy of the Hippocratic Oath.
also according to the prosecutor in this case was quoted as saying: The prosecutor argued that prescribing any opioid medication was illegal. So it is ILLEGAL to prescribe – per federal law – any opioid medication that has been proven by the FDA as safe for use in humans.
FDA is part of the Executive Branch of the Federal Government as is the federal prosecutors under the Presidential Cabinet Attorney General Position. So we have two parts of the Executive branch of our federal government in TOTAL DISAGREEMENT over the legality of the use of FDA approved opioids.
Since there is no clear cut laboratory tests that will provide the prescriber any measurable intensity of pain for any pt, the prosecutor in this case seems to suggest that prescribing any opioids for a pt without such testing – that does not exist – is irresponsible and thus providing opioids without a valid medical necessity.
This is what the SCOTUS June 2022 (9-0) vote ruling that the DEA/DOJ could not use OBJECTIVE CRITERIA when evaluating a prescribing in treating pts with subjective disease issues. As of making this comment, it does not seem like the DEA has let to change it SOP in evaluating prescribers when they are prescribing opioids for pts suffering from acute & chronic pain.
My decision to enter a plea bargain never felt like a real decision, but instead a foregone conclusion. Though hardly ever stated explicitly, the understanding was that if I were indicted by a grand jury, then it was presumed I did something wrong. Under that perception, the indictment was not an opportunity to explain and defend myself, but a tragedy to accept and mourn. Any attempt to fight the inevitable was considered merely a stage in the grieving process.
I felt trapped and manipulated, my ability to defend myself weakened as my legal options dwindled to nothing but inaction. I felt defiance and disgust that my identity, as a physician, as a person, could so quickly give way to extremism engulfed and defined me. Soon enough, any attempt to justify or rationalize was met with tacit silence, pressed lips, and expressive eyes balancing sorrow and condemnation. Perception became my harsh new reality, defined by the prosecutor, who selectively created the impressions needed to obtain his desired outcome.
The prosecutor obtained a grand jury indictment by focusing publicly and overtly on the undercover agent’s visits as well as the actions and perjured statements of my medical assistant. To coerce a plea agreement, he impressed upon me directly and covertly the regulatory violations of the collaborative agreements I had used in the patient transitions. He claimed the regulatory policies could be considered criminal, and that he would superimpose additional charges if I were not to plead guilty.
Two separate legal strategies, one public, the other private, one to indict, the other to convict through plea—this was the prosecutor’s desired intent from the outset. The pressure to enter into a plea bargain grew heavier with every article, every motion, every misrepresentation gone unchecked, and every legal interpretation twisted and perpetuated, until I stagnated into a state of helplessness, weighing whatever limited options I had left.
After my indictment, I thought, naively, that I could resolve the matter like I had resolved other issues in my clinic, through open and honest communication. I called the police station, where I had been detained, to schedule a meeting to speak with the Munster police officer leading their opioid awareness initiatives. Surprisingly, he invited me to meet later that day.
We discussed the clinic, the quality model, strategies for patient care, and opportunities for physicians and police officers to work together in managing high-risk patients. We spent a significant amount of time discussing how trust in the clinical setting is essential for high-quality, cost-effective medicine. The meeting went well, and the officer invited me to future community events. I left the meeting, feeling content, decidedly confident that the officer had the right impression of me.
Then my phone rang.
My attorney blasted me for doing something apparently so reckless, so foolhardy, that to the interpretive eyes of the prosecutor must have been an attempt to manipulate the police to my advantage. I quickly realized there were no upcoming events or collaborations; there was only the legal case and its interpretations. From then on, I knew the die had been cast. The stain of criminality had left an indelible impression that could never be removed as long as the legal proceedings went on.
At that point, defiance became delusion, and I was left with no legal recourse and no ability to speak the truth. I stopped fighting. Anger became arrogance, so I stopped getting angry. Sadness gave way to acceptance, and I agreed to accept the plea agreement.
My eyes grew heavy under a lingering shame that overtook my face whenever I looked at my wife and now six-month-old son, feeling the sorrow of unconditional support in every broken smile.
My mind never agreed to what my hand eventually signed. I never believed I’d committed a crime over the course of patient care, and to be honest, I believe I was entrapped. Entrapment consists of two parts: inducement and predisposition. Inducement is when law enforcement directly forces a person to commit a crime, and predisposition is when the government influences a person to behave out of character, thereby committing a crime. How is this anything but an attempt to induce me into a crime? When no crime could be induced, law enforcement imposed intense pressure that led to administrative oversights in the collaborative agreements.
I provided good care to a patient who claimed to have a history of leg pain and behaved as if he were a compliant patient. He was agreeable to lowering his pain medication and to imaging studies once his insurance coverage was activated. This led me to believe he was a patient with legitimate medical issues.
The prosecutor argued that prescribing any opioid medication was illegal, and that by trusting the patient, I violated the law by violating my duty as a physician. He cited the phrase that represents a physician’s civic duty: “Do no harm.” Prosecutors and DEA agents take this phrase and interpret it to mean any prescription they believe is medically unnecessary is immediately illegal, regardless of context. In my case, they used the phrase to imply that I blindly trusted an undercover agent by prescribing medication based on his presenting symptoms rather than requiring verification before prescribing any medication. They turned my trust of a patient into a criminal act.
Blind trust is irresponsible and simply bad medicine. However, so is immediately distrusting and requiring the patient to verify medical conditions before treatment is administered. In finding a balance in trusting and verifying, I performed my duty to someone I had every reason to believe had legitimate medical conditions.
I believe I chose the right balance of verification and trust. I believe I was induced. But what I believe matters less than what they interpreted. And that made all the difference.
The CDC’s revised prescribing guidelines retain an anti-opioid bias and do nothing to reverse the harmful policies inspired by the 2016 version.
“I hope I will remain alive for 2023 to see changes in pain control,” a woman I’ll call Nancy H. says in a recent email. “I have been treated with opioids for over 25 years at the pain management center of a world-renowned hospital in Boston. I now am suffering daily because I was force tapered down from 150 milligrams of oxycontin and 60 milligrams of oxycodone per day…to just 60 milligrams of oxycodone.”
As a health care writer and advocate for people living with chronic pain, I get a lot of messages like this one. They reflect the experiences of patients suffering the consequences of opioid prescribing guidelines that the Centers for Disease Control and Prevention (CDC) published in 2016. Those consequences include sharp reductions in medication, undertreatment of pain, reduced access to care, and outright abandonment of patients, resulting in needless suffering and sometimes suicide.
The horrifying fallout from the CDC’s 2016 recommendations, which inspired laws, regulations, policies, and practices aimed at reducing the medical use of opioids, was obvious to patients, pain experts, and the American Medical Association. It attracted attention from the Food and Drug Administration and ultimately prompted the CDC to issue new, supposedly improved guidelines in 2022.
The revised version implicitly acknowledges the damage done by what the CDC describes as “misapplication” of its advice. But the agency’s updated recommendations retain a bias against treating pain with opioids and a preoccupation with arbitrary dose limits. They do little to address doctors’ fears of regulatory or criminal sanctions, and they do nothing to reverse the misguided rules that legislators, regulators, insurers, pharmacists, and health care organizations adopted in response to the 2016 guidelines. A real course correction will require new legislation, which starts with recognizing how those rules have harmed patients like Nancy H.
“Utter Madness”
“The pain and other withdrawal symptoms from this forced taper are horrifying, and the pain I suffer is unrelenting,” Nancy H. writes. “My pain management physician did NOT want to taper me and other patients off of the amounts we were being prescribed. The hospital board mandated that all patients being treated for noncancer pain were to be tapered down to 60 milligrams. My physician and other physicians at the pain clinic were told that they would be fired if they did not taper every patient to 60 milligrams.”
According to the scientifically dubious conversion system used by the CDC, that daily dose of oxycodone corresponds to 90 “morphine milligram equivalents” (MME), a threshold that the 2016 guidelines warned doctors against crossing. The 2022 guidelines omit that recommendation but include a warning that is potentially even more damaging.
“Before increasing total opioid dosage to ≥50 MME/day,” the CDC says, “clinicians should pause, considering that dosage increases to >50 MME/day are unlikely to provide substantially improved pain control for most patients while overdose risk increases with dosage, and carefully reassess evidence of benefits and risks.” Although this daunting advice implies that daily doses exceeding 50 MME are rarely appropriate, millions of patients have been well served by opioid therapy at much higher doses, often for years without negative outcomes.
The 2016 guidelines did not say patients who already exceeded the 90-MME threshold should be forced to get by with less. But that is how the guidelines have been widely interpreted, as illustrated by Nancy H.’s account, which is similar to numerous reports on social media. “Along with so many chronic pain patients,” she says, “I have given up any hope that I will ever receive the pain management treatment that is necessary to have some quality of life.”
The 2016 guidelines, like the revised version published last year, were not supposed to affect cancer patients or end-of-life care. But they contributed to an anti-opioid culture that resulted in shocking maltreatment of patients on their deathbeds.
“My husband, who just died of brain cancer, spent many of his last days in agony,” Rhonda F. reports in a January 2023 email. “I had to fight for him to receive any pain relief. Yes, a wonderful man with terminal brain cancer was forced to suffer. I asked the doctor why nobody was giving Larry pain relief, and he replied, ‘They are all afraid for their licenses.’ My poor, dying husband would moan, lifting his hand to his head, and cry. This is complete and utter madness.”
One Size Does Not Fit All
The madness began with the conviction that pain relievers prescribed by doctors—even for bona fide patients—caused and sustained the “opioid crisis.” But the correlation between opioid prescribing and drug-related deaths that the CDC cited in its 2016 guidelines was no longer apparent after 2010. The 2022 revisions nevertheless falsely assert the same connection, relying on outdated numbers to support the belief that curtailing prescriptions will somehow reduce opioid-related deaths, which nowadays overwhelmingly involve illicit fentanyl.
Meanwhile, at least 40 percent of all U.S. community clinics are refusing to accept new patients for pain management. Many pain patients dropped by their doctors cannot find anyone to continue their care.
The 2022 guidelines say nonopioid therapies are “preferable” for most patients. But medical literature does not support that recommendation, especially for severe pain. No published trials directly compare opioid therapy with nonpharmacological treatments on an either-or basis. When used to supplement pain relievers, alternative treatments such as acupuncture, physical therapy, and counseling offer only marginal and temporary improvements in pain or quality of life. While prescription opioid therapy is not a default first option for all patients, it is indispensable for both acute and chronic severe pain when the alternatives are less effective.
Like the 2016 guidelines, the new version completely ignores genetic variations in drug sensitivity between individuals. Because of those differences, which have been recognized for at least 20 years, the minimum effective dose is estimated to be as much as 15 times higher for some patients than for others with similar conditions. But published medical trials do not address this wide variability, and neither do the CDC’s one-size-fits-all practice standards.
The CDC says its guidelines “should not be applied as inflexible standards of care across patient populations.” But the CDC’s bias against opioid therapy in general and against high-dose therapy in particular, which is based on an exaggerated depiction of the risks it entails, belies that stance.
It seems clear that we cannot rely on the CDC to correct its errors. But state and federal policy makers can take steps to ameliorate the harm caused by ham-handed efforts to reduce the medical use of opioids.
What Legislators Can Do
Clinicians need an evidence-based standard of practice for prescribing opioid analgesics, and they need to be confident that following that standard will protect them from criminal prosecution, regulatory sanctions, and institutional penalties. Such guidance would necessarily replace the CDC’s recommendations, and federal legislation may be necessary to stop the agency from presuming to tell doctors how to practice medicine.
Six U.S. medical organizations have urged an end to “political interference in the delivery of evidence based medicine.” These organizations represent more than 500,000 frontline clinicians and medical students spanning family practice, internal medicine, obstetrics/gynecology, osteopathic medicine, pediatrics, and psychiatry. Additional specialties are represented in the American Medical Association’s Substance Use and Pain Care Task Force, which aims to “promote evidence-based policy to end the epidemic of deaths related to drug overdose.”
A truly balanced practice guideline could be developed by a committee of clinicians who actually practice pain management in communities or hospitals, with representation from clinical specialty academies and organizations. Like the Inter-Agency Task Force on Best Practices in Pain Management that the U.S. Department of Health and Human Services established in 2019, such a committee should also include chronic pain patients and their advocates as voting members.
The committee’s work should start with a few basic principles. Treatment begins with a cooperative, face-to-face relationship between patient and physician. It includes documenting therapy plans, monitoring progress, tailoring treatment to the individual, and educating patients and family caregivers. Doctors and patients should understand the difference between addiction—a compulsive attachment that persists despite identifiable harms—and physical dependence, which involves withdrawal symptoms following abrupt cessation. Clinicians also must recognize that forced tapering of stable patients is never ethically appropriate and may risk patients’ lives.
Pending completion of that project, Congress should require the CDC to withdraw its pain treatment recommendations and notify state medical boards that they should not rely on those guidelines in regulations or practice standards. Congress also should repeal Sections 131 and 133 of the 2018 Veterans Affairs Mission Act, which aim to reduce opioid prescribing throughout the V.A. system, based on the same mistaken premises as the 2016 CDC guidelines. It should direct the V.A. to withdraw its Opioid Safety Initiative and the clinical practice guidelines associated with it, which have been used to justify blanket denial of opioid therapy to veterans.
The Controlled Substances Act, which the Drug Enforcement Administration (DEA) has long deployed against physicians whose prescriptions it deemed medically inappropriate, is another barrier to pain treatment. Last year in Ruan v. United States, the Supreme Court may have reduced that threat by ruling that doctors can be convicted of drug trafficking only if they “knowingly or intentionally” violate accepted standards for medical use of controlled substances.
Amending the Controlled Substances Act could provide further protection for physicians who worry that their good-faith prescribing decisions might jeopardize their liberty, licenses, and livelihoods. Clinical staffs should no longer be subject to coercion by DEA agents who threaten prosecution to obtain testimony against clinicians. Congress should also curtail pretrial asset forfeiture, which often denies clinicians the resources they need to defend themselves effectively in court.
Several states, including New Hampshire, Rhode Island, Oklahoma, Arizona, and Minnesota, have already enacted reforms aimed at protecting clinicians from inappropriate sanctions. These laws are designed to prevent medical boards and law enforcement agencies from penalizing or prosecuting clinicians for “appropriately” prescribing opioids within a “current standard of care.” No one should look to the CDC for that standard.
That 110,000 OD’s in a single year is about TWICE the number of our young soldiers were killed in our 12-14 yrs involvement in the Vietnam war , and we build monuments to honor those deaths. Our country has been at this “war on drugs” for over FIVE DECADES. Probably the only people who would continue to believe that we have made progress is those whose paycheck depends on the war on drugs continuing.
Maybe it is time that we change our laws. It should not be hard to figure out that someone was caught with > one Kilogram of illegal fentanyl powder or > 10,000 illegal fentanyl tablets …their intention is 99%+ for distribution. How many deaths will result from this person(s) transporting these illegal poisonous substances ? Here is an example from July 2022Alleged drug traffickers released from California jail days after caught with 150K illegal fentanyl pills who believes that these two “bad boys” are not going to go back and get more illegal fentanyl tabs and try to get them back on to our streets and cause some of our innocent citizens to OD/poisoned by what/how they making a living ?
What if our federL laws were changed, and well advertised, if you are caught being a “drug mule ” you will be executed on the spot. How much of a difference is there between a drug mule and some guy that goes into some public place and starts shooting up the place. People die, and if the shooter doesn’t commit suicide, the cops will most likely take them out.
If we implemented such a program, I wonder how easy it will be for the cartels to find someone to transport illegal drugs into our country ? The amount of illegal drugs coming into our country and getting to our streets and killing our citizens, might dry up considerably. It will never be zero, but cutting it in half, could save 40,000 lives a year, maybe more.
I asked CHATGPT: how many people are kill with guns every year in USA:
According to data from the Centers for Disease Control and Prevention (CDC), there were 43,559 firearm-related deaths in the United States in 2020. This includes both intentional and unintentional deaths, as well as deaths from legal intervention. Of those deaths, 24,090 were classified as suicides and 19,383 were classified as homicides. The remaining deaths were due to accidental or undetermined causes.
It’s worth noting that the number of firearm-related deaths in the United States can vary from year to year and can be influenced by a variety of factors, such as changes in gun laws, rates of firearm ownership, and levels of violence in society.
There are some bureaucrats/politicians who would like to repeal our 2nd Amendment – the rights to bear arms. Yet, OD/poisoning of all drugs is approaching THREE TIMES the number of people killed with guns. If count just HOMICIDES … it is nearly SIX TIMES.
I heard – several times – on the TV today, a 3 college kids got shot/killed at a university in Michigan… but did anyone hear about the 200 – on average – who died today from using illegal Fentanyl ? I am sure before the day is over, I will hear from some/many politicians/bureaucrats about our need for more GUN CONTROL.
Boards of Pharmacy across the United States risk it all to protect patients as they move forward to regulate mail order pharmacies. The fear we feel as advocating to ensure that patients have safe access to medications may be similar to the fear that they may feel.
Many board members get paid by the companies they regulate as insurance companies have merged with mail order pharmacies and pharmacy benefit managers (PBMs). Optum Rx, CVS Caremark, and Express Scripts are the three largest.
Doing what’s right for the patients could mean that Board members could lose their jobs if employed by one of these large corporations, and independent pharmacists on Boards could get audited out of business by these companies. Some may also fear retaliation in the form of physical harm. Regulators on these Boards that are regulating properly are more heroic today than ever.
I’ve spoken to pharmacists that have received threats, faced audits from these companies that resulted in financial penalties, had private investigators hired to follow them, and received warning letters. The letters stated that sharing negative patient stories that highlighted poor treatment received by these companies went against their contract. Pharmacists have stated that losing one of the contracts with the insurance companies’ pharmacy benefit managers, such as Optum RX, CVS Caremark, or Express Scripts, could mean closing their doors. These three companies oversee their reimbursements, which is an obvious conflict of interest.
As Boards work to put patients ahead of corporate profits, they need our support and protection from these companies. It’s why it’s so important that legislators and Media follow this story and provide an opportunity for regulators to report if regulators, patients, or pharmacists are retaliated against for speaking about the issues or for acting to protect patients. We appreciate that Adiel Kaplan from NBC is committed to reporting on the Boards and updating the public.
Last week, public comment showed that Express Scripts threatened the Oklahoma Board of Pharmacy with a lawsuit if they moved forward with regulation. The board still bravely moved forward. We are beyond thankful for each one of the members, but many of us worry about them at the same time as they are setting a strong stance for other Boards to follow.
Some boards may not believe they have the power to stand against these three giants and regulate such an issue as temperature regulation or delays, but they can. They must start somewhere to leave the future of pharmacy in a better state for patients like my son.
It’s difficult for some to envision a world where medications are handled quickly and safely throughout the supply chain.
If we can envision it, we can help them envision it too.
The lack of regulation has slowed innovation for safe and timely delivery of medications from mail order pharmacies. The regulation should have been in place 20-30 years ago as many patients were beginning to be steered or forced to mail order as the only coverage option. The time is now.
In summary, I’ll always advocate first for patient choice of pharmacy, but today, America desperately needs the Boards of Pharmacy to hear us clearly. We need them to take the first step and truly envision a nation where medications are delivered timely and safely. Then, we must empower and support them as they begin to regulate these issues and, for the first time in our nation’s history, truly protect patients from harm by mail order pharmacies that many are forced to use. In return, we must also ensure Board members are protected.
If you are willing to become more involved in your state to ensure the protection of patients, please let me know. My email is loretta@uniteforsafemeds.com
After a college student finally found a treatment that worked, the insurance giant decided it wouldn’t pay for the costly drugs. His fight to get coverage exposed the insurer’s hidden procedures for rejecting claims.
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In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.
United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.
But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis — an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue and life-threatening blood clots. His medical bills were running nearly $2 million a year.
United had flagged McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought McNaughton’s disease under control after he’d been through years of misery.
On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.
“I knew that was coming,” said Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Kavanaugh replied.
UnitedHealthcare Employees Discuss the Denial of Chris McNaughton’s Claim
David Opperman is an insurance broker who works for UnitedHealthcare. Victoria Kavanaugh is a nurse for United. In this recorded phone call from 2021, the two express relief that a doctor has turned down Penn State student Chris McNaughton’s claim as “not medically necessary.”
Opperman then complained about McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.
The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.
“We’re still gonna say no,” Opperman said.
More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.
Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”
When United refused to pay for McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.
As United reviewed McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering McNaughton’s drug plan.
At one point, court records show, United inaccurately reported to Penn State and the family that McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.
United declined to answer specific questions about the case, even after McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was McNaughton’s well-being.
“Mr. McNaughton’s treatment involves medication dosages that far exceed FDA guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”
But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with McNaughton. In emails, officials calculated what McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.
“This is just unbelievable,” Kavanaugh said of McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
The Same Meal Every Day
McNaughton on the Penn State campus, where he first enrolled in 2020Credit: Nate Smallwood, special to ProPublica
Now 31, McNaughton grew up in State College, Pennsylvania, just blocks from the Penn State campus. Both of his parents are faculty members at the university.
In the winter of 2014, McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.
When McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.
A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. McNaughton’s case was severe.
Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.
McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.
For two years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch and a similar meal for dinner, occasionally swapping in tilapia.
McNaughton at his home in State College, Pennsylvania. When he fell ill with ulcerative colitis he was forced to stop playing college basketball.Credit: Nate Smallwood, special to ProPublica
His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring McNaughton to Dr. Edward Loftus Jr. at the Mayo Clinic in Minnesota, which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.
For his first visit with Loftus in May 2015, McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.
Mornings were the hardest. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the five-minute walk from the hotel to the clinic. When they met, Loftus looked at McNaughton and told him that he appeared incapacitated. It was, he told the student, as if McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.
McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Loftus treated him.
In addition to trying to find a treatment that would bring McNaughton’s colitis into remission, Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection and fatigue. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.
In 2018, Loftus and McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases like colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.
McNaughton receives an infusion of medication to treat his ulcerative colitis at a medical facility in State College. After initially paying for his treatment, UnitedHealthcare began rejecting his insurance claims.Credit: Nate Smallwood, special to ProPublica.
McNaughton had tried individual biologics, and then two in combination, without much success. He and Loftus then agreed to try two biologic drugs together at doses well above those recommended by the U.S. Food and Drug Administration. Prescribing drugs for purposes other than what they are approved for or at higher doses than those approved by the FDA is a common practice in medicine referred to as off-label prescribing. The federal Agency for Healthcare Research and Quality estimates 1 in 5 prescriptions written today are for off-label uses.
There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Loftus has been paid to do consulting related to the biologic drugs taken by McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.
In cases of off-label prescribing, patients are depending upon their doctor’s expertise and experience with the drug.“In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Loftus said.
There was evidence that the treatment plan for McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose — to reduce inflammation in the large intestine — but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.
As for any suggestion by United doctors that his treatment plan for McNaughton was out of bounds or dangerous, Loftus said “my treatment of Chris was not clinically inappropriate — as was shown by Chris’ positive outcome.”
The unusual high-dose combination of two biologic drugs produced a remarkable change in McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to three or four. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.
“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” McNaughton said of the change he experienced with the new drug regimen.
When he first started the new treatment, McNaughton was covered under his family’s plan, and all his bills were paid. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by McNaughton would be covered by United.
McNaughton receiving infusions of medicine used to treat his ulcerative colitisCredit: Nate Smallwood, special to ProPublica
McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.
McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.
In January 2021, McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.
When McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.
Misrepresentations
McNaughton, center, at his home in State College with parents David McNaughton, left, and Janice Light, right.Credit: Nate Smallwood, special to ProPublica
With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive McNaugton of treatment that they considered miraculous.
They turned to Penn State for help. Light and McNaughton’s father, David, hoped their position as faculty members would make the school more willing to intervene on their behalf.
“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Light wrote to a school official in February 2021.
In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”
The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”
During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”
Behind the scenes, McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Kavanaugh, the nurse, said in a recorded conversation.
Victoria Kavanaugh Complains to a United Contractor That McNaughton’s Coverage Request Is “Insane”
McNaughton had been on the treatment for three years and it had put his disease in remission with no side effects.
The family’s relief was short-lived. A month later, United started another review of McNaughton’s care, overseen by Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.
The nurse sent the McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.
Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.
“This school apparently is a big client of ours,” she said. She then shared her opinion of McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”
Victoria Kavanaugh Describes Penn State as a “Big Account for Us”
On a call with an outside contractor, the United nurse claimed McNaughton was on a higher dose of medication than the FDA approved, which is a common practice known as “off-label prescribing.”
MRIoA sent the case to Dr. Vikas Pabby, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of McNaughton’s case was just one of more than 300 Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.
In a May 4, 2021 report, Pabby concluded McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by McNaughton did not support using them in combination.
Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”
Behind the scenes at United, Opperman and Kavanaugh agreed that if McNaughton were to appeal Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Opperman said, according to a recording in court files. At Opperman’s urging, United decided to skip the usual appeals process and arrange for Pabby to have a so-called “peer-to-peer” discussion with Loftus, the Mayo physician treating McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually only occurs after a customer has appealed a denial and the appeal has been rejected.
When Kavanaugh called Loftus’ office to set up a conversation with Pabby, she explained it was an urgent matter and had been requested by McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”
McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.
In the peer-to-peer conversation, Loftus told Pabby that McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.
Following his conversation with Loftus, Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”
When Kavanaugh shared the May 12 decision from Pabby with others at United, her boss responded with an email calling it “great news.”
Then Opperman sent an email that puzzled the McNaughtons.
In it, Opperman claimed that Loftus and Pabby had agreed that McNaughton should be on significantly lower doses of both drugs. He said Loftus “will work with the patient to start titrating them down” — or reducing the dosage — “to a normal dose range.” Opperman wrote that United would cover McNaughton’s treatment in the coming year, but only at the reduced doses. Opperman did not respond to emails and phone messages seeking comment.
McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Loftus who had upped the doses, leading to his remission from severe colitis.
The only thing that made sense to McNaughton was that the treatment United said it would now pay for was dramatically cheaper — saving the company at least hundreds of thousands of dollars a year — than his prescribed treatment because it sliced the size of the doses by more than half.
When the family contacted Loftus for an explanation, they were outraged by what they heard. Loftus told them that he had never recommended lowering the dosage. In a letter, Loftus wrote that changing McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”
It would not be until the lawsuit that it would become clear how Loftus’ conversations had been so seriously misrepresented.
Under questioning by McNaughton’s lawyers, Kavanaugh acknowledged that she was the source of the incorrect claim that McNaughton’s doctor had agreed to a change in treatment.
“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”
Kavanaugh did not respond to emails and telephone messages seeking comment.
When the McNaughtons first learned of Opperman’s inaccurate report of the phone call with Loftus, it unnerved them. They started to question if their case would be fairly reviewed.
“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”
A Buried Report
While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.
On May 21, 2021, United sent the case to one of its own doctors, Dr. Nady Cates, for an additional review. The review was marked “escalated issue.” Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.
Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”
When he had practiced, Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.
He said his review of McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of McNaughton’s case.
Dr. Nady Cates, a United Medical Director, Explains That He Copied and Pasted the Text of His Decision to Deny McNaughton’s Care
In the deposition, Cates tells McNaughton’s lawyer that he copied the recommendation of Pamela Banister, a nurse for United, rather than writing his own decision.
Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that McNaughton had failed other treatments or that Loftus was a leading expert in his field.
“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Cates in his deposition. He responded, “Yeah.”
Attempts to contact Cates for comment were unsuccessful.
At the same time Cates was looking at McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Loftus warning of the life-threatening complications that might occur if the dosages were reduced.
On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.
Dr. Nitin Kumar, a gastroenterologist in Illinois, concluded that McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”
Unlike other doctors who produced reports for United, Kumar discussed the harm that McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”
When Kavanaugh learned of Kumar’s report, she quickly moved to quash it and get the case returned to Pabby, according to her deposition.
In a recorded telephone call, Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Pabby. “I appreciate that,” Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”
MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Pabby again rejected McNaughton’s treatment plan. While noting it was “difficult to control” McNaughton’s ulcerative colitis, Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”
In a deposition, Kavanaugh said that after she opened the Kumar report and read that he was supporting McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Pabby for review.
Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”
When asked if the Kumar report caused her any concerns given his warning that McNaughton risked cancer or hospitalization if his regimen were changed, Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”
In a court filing, United said Kavanaugh was correct in insisting that Pabby conduct the review and that MRIoA confirmed that Pabby should have been the one doing the review.
The Kumar report was not provided to McNaughton when his lawyer, Jonathan Gesk, first asked United and MRIoA for any reviews of the case. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Kavanaugh mentioned a report number Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.
Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
A Sense of Hopelessness
McNaughton on the Penn State campusCredit: Nate Smallwood, special to ProPublica
When McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.
It was a striking contrast to the previous six years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.
United, in correspondence with McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.
The idea of changing his treatment or stopping it altogether caused constant worry for McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”
McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.
McNaughton and his parents talked about him possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.
Loftus connected McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.
The psychologist, Tiffany Taft, said McNaughton was not an unusual case. About 1 in 3 patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.
“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”
In the case of McNaughton, Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Taft said. The physical and mental symptoms McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.
In early June 2021, United informed McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would only pay for a treatment plan that called for a significant reduction in the doses of the drugs he took.
United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”
In August 2021, McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported McNaughton’s claim for treatment rather than looking for ways to deny coverage.
United, in a court filing, said it did not breach any duty it owed to McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Loftus, according to an email sent by United’s lawyer.
The Cost of Treatment
An order form for medications given to McNaughtonCredit: Nate Smallwood, special to ProPublica
It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the U.S. is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.
A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.
United officials did not make the cost of treatment an issue when discussing McNaughton’s care with Penn State administrators or the family.
Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.
Behind the scenes, however, the price of McNaughton’s care was front and center at United.
In one email, Opperman asked about the cost difference if the insurer insisted on only paying for greatly reduced doses of the biologic drugs. Kavanaugh responded that the insurer had paid $1.1 million in claims for McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.
United was keeping close tabs on McNaughton at the highest levels of the company. On Aug. 2, 2021, Opperman notified Truxal and a United lawyer that McNaughton “has just purchased the plan again for the 21-22 school year.”
A month later, Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on McNaughton in the prior plan year.
United officials strategized about how to best explain why it was reviewing McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Kavanaugh offered as a potential talking point in an April 23, 2021, email.
Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than two decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.
The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.
When discussing the case with Penn State, Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
“Betrayed”
McNaughton looks out a window at his home in State College.Credit: Nate Smallwood, special to ProPublica
McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting McNaughton’s claims into pending status.
McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.
In June 2021, just a week after United told McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.
In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for McNaughton to “the appropriate health care professionals.”
In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give — with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”
Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.
When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”
In April 2022, United began paying Klinger’s salary, an arrangement which is not noted on the university website. Klinger appears in the online staff directory on the Penn State University Health Services webpage, and has a university phone number, a university address and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.
The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.
The family was dismayed to learn that Klinger was now a full-time employee of United.
“We did feel betrayed,” Light said. Klinger did not respond to an email seeking comment.
McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.
McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.
He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.
He plans to reenroll in the United health care plan when he starts school next fall.
Do You Have Insights Into Health Insurance Denials? Help Us Report on the System.
Insurers deny tens of millions of claims every year. ProPublica is investigating why claims are denied, what the consequences are for patients and how the appeal process really works.
Update, Feb. 10, 2023: On Feb. 9, lawyers representing UnitedHealthcare and Christopher McNaughton filed a joint stipulation of dismissal in federal court as part of an agreement to settle the lawsuit brought by McNaughton. United did not respond to a request for comment. A lawyer for McNaughton said he could not discuss the terms of the settlement.
A Yale professor suggested Japan’s elderly population should participate in a “mass suicide” for the sake of the younger generations in the country.
Yusuke Narita, who teaches economics, advocated for euthanizing Japan’s elderly in an interview with the New York Times.
“A Yale economics professor has some ideas for how to deal with the burdens of Japan’s rapidly aging society. The ‘only solution,’ he said, is mass suicide of the elderly, including ritual disembowelment,” the Times wrote in a Twitter post promoting the story.
A Yale economics professor has some ideas for how to deal with the burdens of Japan’s rapidly aging society. The “only solution,” he said, is mass suicide of the elderly, including ritual disembowelment. https://t.co/krlL3Ytd2e
Times’ reporters Hikari Hida and Mokoto Rich defended the professor, saying his words were “taken out of context.”
The journalists said Narita was referring to “a growing effort to push the most senior people out of leadership positions in business and politics — to make room for younger generations,” per a Fox report.
Narita also walked back his radical comments.
The New York Times added that the professor informed the publication that he does not use the words “mass suicide” or “seppuku” anymore when discussing the topic. Narita called his usage of these words “an abstract metaphor.”
President Biden, in his state of the union messages, stated that he was going to improve SS/Medicare financial viability by 20 yrs. Economics 101 would suggest that this can only be accomplished primarily in two ways… increase revenue (taxes) and/or reduce expenses. Since Medicare/Medicaid/SS is the bulk of the Fed annual budget, There are a large number of our citizens that are high acuity (expensive) pts… Receiving all sorts of monetary and many other low cost/free products/services from the FEDS. Historically, Congress has continued to “kick the can down the road’ when it comes to properly funding all of these social entitlement programs, it seems that Congress may be finally running out of road to kick the can down.
this graphic I dug out of my graphic library on my computer and it has a date of 2014 on it. Last year it is claimed that 110,000 OD’s from ALL DRUGS, which included some 70K-80K OD’s involved illegal fentanyl. That number of “dead bodies” from drug OD’s is abt TWICE the number of our soldiers that died during the 12 -14 yrs that the USA was involved in the Vietnam war. and we have built monuments to honor all of those young men that lost their lives in that war. Is it just me, or dose it seem strange that the number of reported drug OD’s is up SIX – SEVEN times in about EIGHT YEARS, while the number of Rx opiates has been reduced by abt 60%. I guess that is what everyone gets when there is no previous experience nor educational requirements to be elected to Congress.
Over 88 percent of opioid overdose deaths now involve either heroin or fentanyl. Targeting prescriptions is not an efficient way to address mortality.
As Americans continue to die from drug overdoses at an increasing rate, policy makers are seeking interventions to reduce reckless medical practices that put patients in danger of addiction. Many of these proposedlawsseek to limit the extent to which patients can access prescription opioids from their physicians. But as our new study, published this week in the Yale Law & Policy Review Inter Alia, argues, prescription opioids are not to blame for today’s crisis.
Laws that arbitrarily set duration or quantity restrictions for opioid treatment regimens are premised on the belief that increased access to prescription opioids has led to an increase in addiction and, ultimately, overdose deaths.
However, while opioid deaths continue to soar, opioid prescribing rates have decreased every year since 2012. Further, nonmedical use of prescription opioids has remained relatively stable over the past two decades. As we point out in our study, the popularized spike in reported nonmedical opioid use rates between 1998 and 2002 was most likely caused by major changes in survey methodology. And if there was a true increase in nonmedical opioid use, it would have been due to codeine, not the overprescribing of common pain relievers like OxyContin. The claim that the introduction of OxyContin in 1996 “fueled” prescription opioid use is simply not supported by the data.
Such claims about Purdue Pharma, however, were echoed during last week’s House Energy and Commerce hearing on combatting fentanyl overdoses. Rep. Tony Cárdenas (D–Calif.) prefaced his questioning with “Purdue, the Sackler family, and crime pays—still one of the richest families in the world…who was a big part of where we are today.” Rep. Mariannette Miller-Meeks (R–Iowa) shared a similar sentiment: “As we know, a lot of opioid addiction has started through post-operative care and pain management, pain relief.”
But it is illicit opioids like heroin and fentanyl, not prescription pain relievers, that are primarily to blame for today’s opioid crisis. By decreasing access to legal channels of prescribing, laws restricting the use of prescription opioids only increase the likelihood that a pain patient will need to turn to the black market to meet his demand for opioids with dangerous illicit drugs.
And yet, academics and policymakers continue to pursue reforms that would only exacerbate this issue. For example, Loyola Marymount University law professor Rebecca Delfino proposed that Congress adopt the Prescription Abuse and Prevention Act (PAPA), a law that would make it easier to prosecute physicians for violating the Controlled Substances Act (CSA). No legislation has yet to be introduced that cites PAPA, but policy makers have shown an appetite to criminalize doctors for prescribing opioids in the past.
Under the CSA and regulations pursuant to it, it is illegal for a physician to “knowingly or intentionally” prescribe a controlled substance unless the prescription is “for a legitimate medical purpose…in the usual course of his professional practice.” Like the CSA, PAPA offers an intent or knowledge mens rea standard, but also allows a “presumption of knowledge” to be established by a “doctor’s expert knowledge, practice experience, and specialized medical training.”
Simply put, if a patient overdoses on a medication that was prescribed by a physician, the event itself might be sufficient to convict the prescriber of second-degree murder. This is because the doctor’s expertise should have prevented the patient from being in such a vulnerable situation in the first place.
Although it shouldn’t be expected that prosecutors would go after every physician whose patient overdoses under PAPA, the fact that such an event would likely lead to an automatic conviction after a charge would worry many physicians. Moreover, PAPA could grant prosecutors the arbitrary authority to incarcerate any physician whose patient overdoses while under his care. Such potential liability would lead to further reductions in prescribing across the country, which would only increase illicit opioid deaths.
Last term, the Supreme Court clarified in Ruan v. United States that in order to be liable under the CSA, a physician must have “knowingly or intentionally acted in an unauthorized manner,” rather than merely intended to or known that he was prescribing some controlled substance. While the CSA regime is not perfect, the ruling in Ruan provided much-needed clarity to the standard of liability under the CSA and shielded physicians from facing prosecution for simply doing their job as authorized.
Criminalizing doctors is not the path to ending the opioid crisis. As much of the literature indicates, opioid prescriptions rarely lead to addiction when treating either acute or chronic pain. Given that over 88 percent of opioid overdose deaths now involve either heroin or fentanyl, targeting prescriptions is not an efficient way to address mortality. The way forward is to expand access to both addiction and pain patients, so that those who are in most need of a safe environment to consume opioids can do so legally.
Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.
There is no doubt that people will talk about the case of Shanti De Corte not only because of the reason stated in her euthanasia request but also because someone so young was able to meet the strict conditions required for the law to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.
On May 7, surrounded by her family, Shanti was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Shanti had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Shanti was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
Eleven Antidepressants Daily
A few weeks after that March day, Shanti was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Shanti was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”
It was a brief respite. In 2020, Shanti attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Shanti submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
A Small Proportion
Last March, the Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering — which is constant, unbearable, and cannot be alleviated — results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.
I have often heard that those involved in our legal system have stated that a GRAND JURY is so RIGGED that they could indict a HAM SANDWICH !
