When the FEDS tries to control prices – shortages appear and services deteriorates.

The Red Wedding for Rural Pharmacies

https://mattstoller.substack.com/p/the-red-wedding-for-rural-pharmacies

Biden just tried to regulate CVS, United Health, and Cigna. Cigna struck back, and is now trying to wipe out independent pharmacies and harm patients. Plus, antitrust enforcers are getting real.

Welcome to BIG, a newsletter about the politics of monopoly. If you’d like to sign up, you can do so here. Or just read on…

First some good news. Last week, I reported on how a bad judge dismissed an important antitrust suit against Amazon. Well the state Attorney General involved, Karl Racine, just said he will be filing a motion for reconsideration, which is basically an appeal. Yay!

Ok, onward. Today I’m writing about what happens when a monopolist gets mad. In this case, it’s health giant Cigna taking revenge on rural pharmacies and patients after the Biden administration tried to slightly reduce the firm’s profits from Medicare prescription drug benefits.

I’ll also show how antitrust enforcers have stopped being polite and are starting to get real. The FTC’s Lina Khan is going after TurboTax maker Intuit for false and deceptive practices, and the Antitrust Division’s Jonathan Kanter blocked a big but obscure merger of port crane producers.

And now…

Express Scripts CEO Tim Wentworth discusses his new strategy with independent pharmacist representative Robb Stark.

The most famous episode of the HBO hit series Game of Thrones was The Rains of Castamere, otherwise known as the ‘Red Wedding.’ The Red Wedding is perhaps the ugliest and most disproportionate sense of revenge ever aired on TV. In it, a regional warlord named Robb Stark attends a wedding of one of his vassals that is supposed to help patch up a minor dispute with a fellow warlord, Walder Frey. The wedding is at Frey’s castle, and Frey invites Stark, his family, and his soldiers to feast. For a time, everyone makes merry, but towards the end of the evening, Frey has his troops ambush Stark and his now-drunk band. Frey has everyone massacred, and even has one of his soldiers stab Stark’s pregnant wife in the belly to ensure he kills the unborn child.

The message from Frey to all future rivals was crystal clear. Don’t mess with me. Though fictional, Game of Thrones draws from medieval history, and such tales of vengeance are not unusual. English history, French history, and many empires of conquest pursued such a strategy of brutalizing subjects so viciously they wouldn’t consider fighting back in the future. These strategies are common because they work. For instance, Mongol empire had many cities surrender without a fight, due to fear that the Mongols would massacre everyone inside should they put up an inch of resistance.

The point of these stories isn’t just about geopolitics, but what happens when humans have too much power over other humans. Which brings me to the problem of monopolies, and what some of them do when they are even slightly challenged. A few months ago, the Biden administration put out a rule to regulate the pharmacy benefits management business, an opaque but massive part in the pharmaceutical drug supply chain. PBMs handle the drug benefit piece of insurance plans. They maintain a list of drugs for insurance companies, they negotiate drug prices, and they manage reimbursements to pharmacies.

The original idea behind PBMs is they would be able to get enough bargaining power by representing multiple insurance companies that they could negotiate to bring down drug prices. And accumulate bargaining power they did, merging until three PBMs control 80% of the insurance market. They are also vertically integrated with insurance companies and drug store chains. The top three PBMs are owned by CVS, United Health, and Cigna.

Unfortunately, because of an exemption from anti-kickback laws, PBMs don’t use their bargaining power to reduce consumer prices. Instead, they force pharmaceutical firms to compete over who will give the PBM the biggest kickback, which in the industry is known as a rebate. Take insulin. In 2013, Sanofi gave a 2-4% kickback to PBMs to prefer their product to customers. In 2018, that number went up to 56%. In other words, more than half of the price of insulin is going to a middleman who does nothing more than push around paper.

The many bad practices of PBMs are legendary. PBMs often force customers to buy more expensive drugs over their generic counterparts, likely because they get kickbacks when customers do so. This ends up making this obscure group of firms a lot money. The combined revenue of the top three firms, who comprise just a small part of the U.S. health system, is larger than the entire amount France spends on all medical care for its entire population.

It gets worse. PBMs all own mail-order pharmacies, and they are increasingly mandating that patients use those mail-order pharmacies instead of the local pharmacy around the corner. Moreover, PBMs now have so much power they are able to claw back money randomly from pharmacies months after a drug was dispensed, using something called a Direct and Indirect Remuneration fee. (DIR fees are only used for Medicare plans, but that is still 37% of the market.) For independent pharmacies, DIR fees are impossible to plan for, they are opaque, and they end up raising prices for consumers.

PBMs are particularly bad for independent pharmacies, who are a critical lifeline in many underserved parts of America. 77% of independent pharmacies serve communities with fewer than 50,000 people. In these places, the independent pharmacist often is the health care infrastructure. Seven in ten do free home delivery, a service which is virtually non-existent with chains. The amount that PBMs have been reimbursing these pharmacists has been going down for years, to the point that many are losing money depending on the medicine they are filling for customers. To put it differently, it’s the equivalent of Amazon raising fees on third party sellers, or Tyson cutting the amount they pay to cattle ranchers.

A few months ago, the Biden administration proposed eliminating most DIR fees, which would get rid of a good, but not critical, profit center for giant PBMs. It looked like a nice win for the anti-monopolists, patients, and independent pharmacies. Last week, however, a contact passed me a new contract from Express Scripts, the giant PBM owned by Cigna.


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Cigna has about a quarter of the PBM market, which means that one out of every four people who goes to a pharmacy to get drugs is using Cigna insurance. There’s regional variation, so in some places Cigna won’t have much market share, while in states like Georgia, something like 50% of the Medicare drug plans are Cigna plans. As one pharmacist put it to me, “If you don’t sign these contracts, then a third of patients won’t come to me because they won’t be able to get their services through their insurance benefits.” In other words, pharmacists can’t turn away a third of the people who come into the store, so they tend accept whatever terms Cigna offers.

And as it turns out, Cigna’s offer to pharmacists just got a lot worse. PBM pricing is insanely weird and complex, so I’ll try to explain it to you. The short story is Express Scripts is cutting revenue to partners so significantly that any independent pharmacist who accepts Express Scripts customers – which can be up to half of all customers depending on the region – will now lose money going forward on Express Scripts customers.

Here’s the contract. First, take a look at the intro page.

Express Scripts is very clear that this new contract is done entirely because of the new regulation, and the new terms are “intended to offer participating Providers the same financial value” as the old one with DIR fees. So that’s clear enough. But that’s not all. In the last paragraph, Express Scripts writes, “No action is needed to accept participation in this Network. Should you wish to decline participation, you may so so within the time allotted under your Pharmacy Provider Agreement.” For most contracts under Express Scripts, that time allotted is ten days. In other words, Cigna is sending an important new contract to its partners, and if they don’t say no in ten days, they have said yes. Contracts usually are two way agreements by both parties, so this strikes me as an abusive way of conducting business.

And the reason why is that the pricing has changed.

Pricing in this industry is weird and insane, but I’ll try to make it as simple as possible. (If you want to understand it for real, here’s an hour and a half-long podcast teaching you the language of pharma pricing.) Pharmacists buy branded drugs at a rate based on something called the Average Wholesale Price (AWP), minus roughly 20%. To make a profit selling a branded drug, a pharmacist needs to be reimbursed at a higher rate than that amount. Under the new contract, for a prescription of less than 30 days, pharmacists will now get the average wholesale price minus 26.3%, and for filling one of more than 30 days, they will get the average wholesale price minus 31.30%. In other words, every branded drug through Express Scripts means that the independent pharmacist loses money. (In case you’re wondering why pharmacists don’t just raise prices to cover the extra cost, they can’t. They have no power over prices, everything works through reimbursement amounts set by contracts with PBMs.)

As a specific example, filling one prescription of Trelegy Ellipta, which is an asthma medication, using the 2023 rates would result in one pharmacist losing $248. And that’s just on one drug. In other words, these contracts are designed to make it so that independent pharmacists can no longer accept Express Scripts customers without losing money.

Such an action is quite ugly for a monopolist, to take umbrage at a slight harm to their profit and decide to salt the earth in response. It may also be illegal, as Medicare part D plan offers must actually have a network of pharmacies that is convenient for 90% of their Medicare customers, and kicking most rural pharmacies out of a network will likely do that. But that’s not the Red Wedding part of this situation, because there is also real physical harm, not just economic damage, occurring as a result. What CVS, Cigna, and United Health are all doing is pushing customers to order medicine from their mail-order pharmacies, which brings them higher profit margins. These mail-order pharmacies, in order to generate high margins, are often poorly run, with little customer service and frequent mistakes.

What happens to the patients? Well back in February, the Federal Trade Commission opened up a docket for public comments on this topic, and here are a few of them.

My insurance companies uses Express script. As a cancer patient my meds never arrived on time, overheated from improper packing which caused them to be not viable. Also I would get the runaround multiple times for trying to get the medication‘s. This was a life-saving drug and I’ve never had anything but problems. Because of a lot of express scripts in competency, my medication failed to work and my disease mutated which resulted in me having to take a different course of action in order to save my life. I think you need to look into the corporate greed of this company and all that they do in regards to providing people with life-saving medication’s.

And another.

Large pharmacy benefits managers like have become a nightmare to deal with. My daughter suffers from epilepsy and has been on several medications over the years, generally with 2-3 at the same time. First, it starts with pushing you to generic medications, which they source from the lowest cost providers with no consistency. One month the pills are tiny, the next they are large for the same medications. Then they drop coverage for certain medications mid year. Then, they punish you with ridiculous fees if you don’t use a preferred provider for monthly maintenance medications. What do you know, they are the only preferred provider. Generally I get to use our local pharmacy for 2-3 months before the crazy fees start. With constant medication adjustments to my daughters meds, I am unable to make quick adjustments with these 3 month scripts. Then, I hold my breath to make sure nothing is messed up with shipping.

And another.

I am forced by my insurance company to get my prescription through Optum Rx; if I go through them, it’s covered, and if I go to the pharmacy (which I’d prefer), it’s not. Why? The prescription is supposed to be covered, and I should get to choose my pharmacy. Instead, I’m forced to refill well ahead of time, to allow for unpredictable shipping times, and then I have to worry about the effectiveness of the pills because the packaging doesn’t protect against the weather. I live in Texas, where many months out of the year, my mailbox (not to mention the mail truck) is like an oven. It’s hard to believe the medication isn’t damaged by that. It should be illegal for companies to risk people’s health this way just for a profit.

And a cancer center specialist.

I work in a cancer center. I am trying to help my patient access Ibrance for her breast cancer. Her copay is ~$2000. I have found a pharmacy who has an internal grant fund that she qualified for and they will cover her copay. However, she cannot use this pharmacy because her insurance / PBM mandates she use CVS Specialty pharmacy. Therefore, she will not be able to afford her life-saving/prolonging medication. We are attempting to get her signed up for free drug through the manufacturer; however, in the meantime, until she is approved, she is going without. All because her insurance/PBM mandates she fill with CVS Specialty.

There are hundreds of comments on the docket, and these are a drop in the bucket. You can check out the awful reviews for Accredo, a mail-order specialty pharmacy owned by Express Scripts, if you want more. People are being hurt, badly, and probably dying, because PBMs are directing more people to their mail order pharmacy business. (In case you’re interested in why this is legal, it’s because economists at the Federal Trade Commission argued since the 1980s that this practice is efficient.)

What Express Scripts is doing wouldn’t matter if large PBMs didn’t have market power or engage in practices to get kickbacks, because then pharmacists could negotiate on a more equal level and reject contracts that forced them to lose money, and PBMs wouldn’t have the incentive to play administrative and financial games with people’s lives. Everything would be a lot more straightforward, and pharmacists would get paid for dispensing the medication people need at a reasonable price. But Express Scripts does have market power, and pharmacists have a really tough time saying no and losing access to their customers.

For now, it seems like Express Scripts is the only large PBM taking this approach. But if the other two dominant PBMs follow along, and I expect they will, then independent pharmacies will basically no longer be able to accept Medicare prescription drug plans. And that’s a large chunk of their business. A lot of people will then be forced to get their medicine through the mail, and be on hold when those poorly run specialty pharmacists get their orders wrong. That’s not fun when you are ordering clothing. It can be deadly when it’s the medicine you need to stay alive.

This could get interesting, especially for those people who live in a rural area.  Medicare part D and Medicare Advantage prgms are both provided by FOR PROFIT INSURANCE COMPANIES… where the FEDS pay them so many $$$ per pt per month.  The PBM’s “negotiate” discount/rebates/kickbacks from the Pharmas… on some meds that can be has high as 75% of the Average Wholesale price and basically that means that the particular med is on the PBM’s approved med list and no prior authorization required. Currently, those “negotiated” med prices discount … typically goes into the coffers of the PBM, not shared with the pt.

I think that if you go up to the top 5 PBM Part D & Advantage prgms… it would include abt 90% of all Rxs would be controlled by those 5 and “controlled” means what meds they will pay for and how much the pharmacy gets paid and how much copay the pt pays.

All of these PBM’s have highly automated/computerized mail order pharmacy , that will fill more Rxs in ONE HOURS that a retail community pharmacy will fill in a week or two.  I am sure that the PBM’s will try and convince Congress that they have met the convenient for 90% of their Medicare customers with the claim that their mail order pharmacy is as close as the pt’s mailbox.

Unfortunately, if you look at your OTC medications, most say state to store at room temp, some Rx meds I have the storage requirements is 68-77F… others have 36F – 77F …. Few/none of the mail order pharmacies ship a pt’s Rxs in containers that will maintain the required storage temp as required by the FDA, USP, NF.  Unfortunately, no federal oversight entity worries about mail order firms not meeting those storage requirements nor attempts to enforce them meeting those temperature storage requirements.

Also, the first of this year the USPS announced that they were extending the expected time for a package to move from shipper to final destination.

I can just imagine, a mail order pharmacy refusing or requiring that they will not accept a C-II to be filled until the pt is down to 2 days supply on hand and the shipping could take 3-4+  days. They may even refuse to ship a C-II by USPS and require the pt to find a local pharmacy that is in the PBM network.

For those pts who are patronizing a chain pharmacy and not happy with the service level that they get, just wait until they have to deal with a pharmacy that is 100’s or 1000’s of miles away and your only way to contact them is via phone call or email .

 

CVS Health: A totally abuse of power! A mental and emotional abuse of pharmacists who are trying to keep their head above water

Dear CVS Health , you are the epitome of bullying:

Today, I attended Oklahoma Board of Pharmacy meeting. I would say that our board has been particularly very involved in the discussion of working conditions and was one of the very states to put together a short staffing form which will be updated soon. It is amazing and encouraging.

And the board is asking pharmacists to fill that form and so am I. But I have known for a while that Pharmacists were struggling with the fear of being retaliated against and rightfully so.

And today, I stand here, with a much public disappointment and even disdain of what CVS Health is doing . A totally abuse of power! A mental and emotional abuse of pharmacists who are trying to keep their head above water!

CVS is asking their pharmacists to notify them before they fill the short staffing form. And because they are who they are, they will come back with reasons and excuses to validate this. Or deny it! Don’t worry, it has been very much confirmed!

But please don’t tell me this not a display of bullying and abuse!!!

How do we expect pharmacists to report short staffing, abusive working conditions?

And I know you think that pharmacists don’t have to follow this demand from CVS Health . But just the simple ask from them is enough to kill any hope pharmacists have.

I don’t know what the board plans to do once they get this information ( which has been confirmed).

But let it all be known that this company and its culture is killing our profession and the very essence of freedom we have as practitioners and I hope every pharmacy entity , association , board of pharmacy is putting something in place to protect our voices!!! And we pharmacists who are not affected by this, should all bind together and stand up for our fellow pharmacists, technicians, students and get involved and support our associations and board of pharmacy and be the voices for others!

Let’s get this message out!

Petition to grant RaDonda Vaught clemency garners 120K signatures

Petition to grant RaDonda Vaught clemency garners 120K signatures

https://www.beckershospitalreview.com/nursing/petition-to-grant-radonda-vaught-clemency-garners-120k-signatures.html

More than 100,000 people have signed a national petition calling for clemency in former nurse RaDonda Vaught’s criminal case.

Ms. Vaught was convicted March 25 of criminally negligent homicide and abuse of an impaired adult for a fatal medication error she made in December 2017 while working as a nurse at Vanderbilt University Medical Center in Nashville, Tenn. 

As of March 29 at 9 a.m. CT, more than 123,000 people had signed the petition hosted on change.org. The petition comes as nurses nationwide have spoken out against the conviction, saying it sets a dangerous precedent for the profession. 

“We are deeply distressed by this verdict and the harmful ramifications of criminalizing the honest reporting of mistakes,” the American Nurses Association and Tennessee Nurses Association said March 25.

The Nashville District Attorney’s Office has stood behind the conviction, saying it is not an indictment against the nursing profession or medical community but a response to Ms. Vaught’s “gross neglect.” 

Ms. Vaught’s sentencing is scheduled for May 13. She faces up to eight years in prison.

Another ADA civil rights violation – discriminating against people with OUD treatment

Indiana board ordered to end bias against nurses with opioid use disorder

https://www.beckershospitalreview.com/nursing/indiana-board-ordered-to-end-bias-against-nurses-with-opioid-use-disorder.html

The Indiana State Nursing Board discriminates against nurses with opioid use disorder and must work with the Justice Department to end the civil rights violations, the U.S. Justice Department concluded in a recently released investigation.

The investigation, published March 25, was prompted by a complaint from a nurse alleging that she was denied participation in the Indiana State Nursing Assistance Program because she takes medication to treat opioid use disorder.

Investigators found the board violated the Americans with Disabilities Act by prohibiting nurses taking this medication to participate in the program, which rehabilitates and monitors nurses with substance use disorders, and is often required to maintain an active license or have one reinstated. 

A letter detailing the findings asked the board to work with the Justice Department to resolve the identified civil rights violations. 

To all Oklahoma patients and perhaps others across the nation:

To all Oklahoma patients and perhaps others across the nation:

If your doctor or nurse sees any type of unsafe practices, you would want them to report it for your safety. Right?
Now, last year, in order to address concerns about safety in the chain pharmacies and the lack of staff which caused delays in prescriptions and errors,
Oklahoma board of pharmacy put together a form which Pharmacists could fill to report lack of personnel.

Today, we have discovered and confirmed that CVS Pharmacy is requiring their pharmacists to let them know before they fill that particular form and report unsafe conditions to Oklahoma board of pharmacy.

Now to put that into perspective. Chain Pharmacists have already been afraid to speak up for their patients and themselves because their employers have found tactics to retaliate and intimidate them.
By CVS Health asking this of their pharmacists, the company is indirectly pushing their pharmacists to remain silent on the detrimental working conditions in the pharmacy.
As a patient and for the sake of your family, you should be concerned about this.
This is a tactic to intimidate pharmacists who are trying to be your advocate. This is a tactic to burry their voices.
Please know that Pharmacists are trying to be out there and to protect you! Please spread the word around the issues you are experiencing. Let your lawmakers know! Get in touch with our board of pharmacy.
Those companies are abusing their power with no fear of being held accountable for the harm they are causing!
Start to advocate for yourself and your loved ones.

 

FED LAW: those who are violating it – is the same who are suppose to enforce it ?

42 U.S. Code § 1395 – Prohibition against any Federal interference

https://www.law.cornell.edu/uscode/text/42/1395

Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, § 1801, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 291.)

federal mask mandate on public transportation: exceeds the authority of President Biden’s Centers for Disease Control and Prevention

More than 20 states sue CDC over federal mask mandate on public transportation

https://www.abc15.com/news/national/coronavirus/more-than-20-states-sue-cdc-over-federal-mask-mandate-on-public-transportation

TALLAHASSEE, Fla. — 20 states are joining the state of Florida in a lawsuit against the federal mask mandate on public transportation.

Attorney General Ashley Moody and Governor Ron DeSantis announced the lawsuit on Tuesday.

In a press release, Moody’s office called the mandate “unlawful” and said it “exceeds the authority of President Biden’s Centers for Disease Control and Prevention.”

The other states included in the suit are Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, Ohio, Oklahoma, South Carolina, Utah, Virginia and West Virginia.

In several instances, the lawsuit calls the mask mandate “arbitrary and capricious.”

Florida leaders claim there is no “high-quality data to support the efficacy of mask mandates, case numbers and hospitalizations experiencing a large downward trend, and 81.7% of the population having received at least one dose of the COVID-19 vaccine.”

The lawsuit doesn’t just call for an end to the mandate and a permanent injunction against enforcement, it also calls for the defendants to pay for attorney fees and other costs.

 

 

ACLU PA : sues over state courts prohibited/limited meds for OUD – VIOLATION OF ADA

How many pts have contacted the ACLU in their state about chronic pain pts being civil rights discriminated by the CDC prohibiting/limiting being prescribed medication to treat their chronic pain  and be told that the ACLU did not have the resources to deal with that issue ?

Department of Justice Finds PA Court System Violated Federal Law By Banning Medication for Opioid Use Disorder

https://www.aclupa.org/en/press-releases/department-justice-finds-pa-court-system-violated-federal-law-banning-medication

Philadelphia, PA – The U.S. Department of Justice has found that Pennsylvania’s state courts violated the Americans with Disabilities Act when its courts prohibited or limited access to medications for opioid use disorder – specifically methadone, buprenorphine, and naltrexone. The letter of findings, which was published on Wednesday, detailed discriminatory practices in a wide array of court-supervised settings in the Unified Judicial System of Pennsylvania, including drug courts, mental health courts, DUI courts, probation, and parole.

The DOJ’s investigation was initiated after a complainant represented by the Legal Action Center was forced to taper off of buprenorphine under the Jefferson County Court of Common Pleas policy prohibiting “any opiate based treatment medication.” The American Civil Liberties Union of Pennsylvania had fielded a similar complaint from another individual in Jefferson County. The two advocacy groups urged the court to rescind its policy, which it did in 2018.

The federal investigation and its subsequent findings show that several courts in Pennsylvania have engaged in similar practices, in violation of the ADA. Specifically, the DOJ determined that these policies and practices were “rooted in stereotypes and myths, rather than science,” were “not justified by any individualized medical or security assessments,” and “directly conflicted with medical guidance on (opioid use disorder) medication.”

“I feel vindicated,” said LAC’s complainant. “Where I’m from, there’s unfortunately a lot of people who have been affected by the drug epidemic, and, when the court put that order in place, it affected a lot of people. I knew that I had to stand up for what was right, and I’m super grateful that the DOJ stepped in and for everything that LAC did to help me. When I first heard this news, I got choked up because I would have been dead. Suboxone saved my life – there’s no doubt in my mind. There are so many people that need the same help and would benefit from medication for opioid use disorder. We don’t need to bury anyone else.”

“With a record 100,000 overdose deaths in the last year, it is crucial that courts facilitate, rather than hinder, access to life-saving medications for people with opioid use disorder. This letter of findings, when joined with the DOJ’s December 2021 settlement of similar claims against the Massachusetts Parole Board, shows that courts and community supervision entities around the country that engage in such discriminatory practices need to stop now, ” explains Sally Friedman, LAC’s senior vice president of legal advocacy.

“Evidence overwhelmingly shows that medication for opioid use disorder helps people avoid illicit drug use and overdose death and reduces involvement in the criminal legal system,” states Rebekah Joab, a staff attorney for LAC. “Rather than leaving treatment decision-making to individuals and their clinicians, some courts prohibit addiction medication based on their own biases and stigma. These findings put courts on notice that such practices not only violate federal anti-discrimination law, but put individuals at great risk of multiple harmful outcomes.”

“Pennsylvania recorded the fourth highest number of drug overdose deaths in the nation from May 2020 to April 2021,” said Sara Rose, deputy legal director for the ACLU of Pennsylvania. “We hope that Pennsylvania courts will work with the DOJ to ensure that people with opiate use disorder receive the treatment they need and are entitled to receive.”

The DOJ has given the Pennsylvania court administrators seven days to respond.

Will Prosecuting Medical Errors Lead to a Culture of Silence?

This is not the first time that a member of a hospital system that has been convicted for the death of a pt because of a med error. The med error was made by a technician in preparing a IV.. and the pharmacist did not catch the fact that the tech used 26.3% NACl instead of 0.9% NACl in the IV.  This was a decade ago, and back then, many states did not require technicians to be registered or certified.  Because of that the technicality … the tech had no authority by the board of pharmacy… since they only have authority over those who are registered/certified and licensed by the Board of Pharmacy.  There are several related stories and hyperlinks in the hyperlink below.  Just like the issue with the nurse and a pt death, there was a number of “system issues” that contributed to the death of the little girl in Ohio.

Pharmacist Jailed for Fatal Medication Error

https://www.pharmacyerrorinjurylawyer.com/pharmacist_jailed_for_fatal_me_1/

An Ohio pharmacist spent six months in jail for a medication error that led to the death of a two year-old child. Emily Jerry’s parents took her to a Cleveland hospital in February 2006 for the last of a series of cancer treatments. Her doctors ordered an intravenous chemotherapy solution. A pharmacy technician prepared her medication with the incorrect dosage of saline, 23 percent instead of 1 percent, and supervisor Eric Cropp signed off on the technician’s work. The saline amount proved to be lethal. Emily slipped into a coma shortly after the solution was administered, and she died several days later.

Will Prosecuting Medical Errors Lead to a Culture of Silence?

— Healthcare workers fearful of repercussions from former nurse RaDonda Vaught’s conviction

https://www.medpagetoday.com/special-reports/exclusives/97911

Healthcare workers are alarmed by the conviction of former Nashville nurse RaDonda Vaught, who now faces prison time over a medical error.

“We could all and probably have been close to this situation because we’re continuously stretched too thin,” Kelsey Fassold, RN, an ICU nurse, said in a LinkedIn post. “We try so hard to do the best by our patients while the odds are stacked against us.”

Jeremy Faust, MD, MedPage Today’s editor-in-chief, said in an Inside Medicine post that the verdict “may contribute to a culture of silence around medical errors.”

“Such silence may make systemic problems less readily identified and rectified. This is the opposite of what we need,” Faust wrote. “We need to destigmatize human errors, acknowledge them, and learn from them.”

On Friday, Vaught was convicted of negligent homicide and gross neglect of an impaired adult, after she allegedly gave 75-year-old Charlene Murphey the paralytic vecuronium when she was meant to give her the anti-anxiety drug Versed. Vaught had been acquitted of a reckless homicide charge.

Vaught faces 1 to 2 years in prison for the negligent homicide charge, and 3 to 6 years on the gross neglect charge, according to Kaiser Health News. Her sentencing is scheduled for May 13.

Typically, serious medical errors are handled by licensing boards or civil courts — not prosecutors.

The American Nurses Association said in a statement that the “criminalization of medical errors could have a chilling effect on reporting and process improvement.”

“ANA supports a full and confidential peer review process in which errors can be examined and system improvements and corrective action plans can be established,” the statement said. “Transparent, just, and timely reporting mechanisms of medical errors without the fear of criminalization preserve safe patient care environments.”

Faust said that during his career, he witnessed a very similar error. Instead of confusing vecuronium with Versed, Faust said a nurse gave the paralytic rocuronium when she was meant to give the antibiotic Rocephin.

“Fortunately, the mistake was immediately recognized, and the patient suffered no immediate or long-term consequences,” Faust wrote. “In fact, the patient was informed as to what was happening in real time, given a play-by-play narration of what had just happened and what would happen next,” which included giving Sugammadex to reverse the effects of rocuronium.

“The nurse who made the mistake was experienced, respected, and every bit as caring as the very best healthcare colleagues I have worked with over the years,” Faust wrote. “In other words, this was not some green, distracted, or emotionally detached bad apple. In my mind, all of that added up to one thing: this could have happened to anyone.”

“If honest errors lead to criminal convictions, every incentive will be to sweep things under the rug,” Faust added. “If we don’t learn from both our successes and our failures, things will get worse, not better.”

Fassold noted in her LinkedIn post that she considered Vaught’s mistake a “systemic error” and that “when something bad happened, the nurse took the heat.”

“Nurses are constantly put in unsafe and harmful conditions that can and will hurt patients. Not because they’re not trying, but because they’re working themselves to death trying to keep up with what the system demands from them,” she wrote — a sentiment that has echoed throughout the nursing world as it struggled to provide care through the COVID-19 pandemic.

“Nursing ratios are far worse now than they ever have been,” she continued. “How many more situations will occur just like this? It’s time nurses stand up for themselves, their license, and their life. It’s time nurses say no to unsafe assignments. It’s time nurses tell administration that what [they’re] demanding is unsafe and harmful. It’s time we all stand together and demand change.”

Vanderbilt University Medical Center, Vaught’s former employer when the error occurred, said via an email from a spokesperson that it did not have a comment on the verdict.

Can You Be Held Liable for Prescribing Opioids in Good Faith?

Can You Be Held Liable for Prescribing Opioids in Good Faith?

https://www.medpagetoday.com/opinion/second-opinions/97904

The Supreme Court is considering this question in Ruan v. United States

Earlier this month, the Supreme Court heard oral arguments in a case that will impact how doctors can treat patients where opioids are involved. The threshold question in Ruan v. United States, which came to the Supreme Court from the U.S. Court of Appeals for the Eleventh Circuit, is when the care a doctor provides patients crosses the line into a criminal act where the doctor is prescribing opioids.

Xiulu Ruan, MD, practiced medicine as a board‐certified pain specialist in Alabama, and was indicted in 2016 for unlawful distribution of opioids. The jury in the trial court convicted Ruan and other physicians in his practice based on a ruling that did not allow doctors to claim a defense of “good‐faith” where they honestly prescribed opioids under the belief that it was the right thing to do medically. Once the case reached the Eleventh Circuit on appeal, Ruan was essentially doomed, as that federal appellate circuit does not recognize a good-faith defense in cases such as this. He lost and appealed to the Supreme Court on a writ of certiorari, a court process to seek judicial review of a decision from a lower court.

John Brennan, JD, a New Jersey criminal defense lawyer, explains that the heart of the question presented to the Court in this case is what is and isn’t reasonable medical judgment:

“The argument of the doctors involved in the case was that the Supreme Court should look at the good faith of the doctors prescribing opioids. In a situation where a doctor genuinely believes that writing an opioid prescription falls within their normal course of practice, that this should not be viewed as a criminal act and they shouldn’t be convicted of unlawful distribution under the Controlled Substances Act.”

In the recent oral arguments, the Supreme Court Justices seemed to be leaning towards overturning the Eleventh Circuit and siding with the convicted doctors. However, the notion of reasonable belief and subjective intention are going to be difficult to agree upon because they can be a little slippery.

Three Justices — Brett Kavanaugh, Neil Gorsuch, and Chief Justice John Roberts — each expressed concerns for doctors who would be on the wrong side of a close professional judgment call, pointing out that doing so could result in decades in prison. When Justice Clarence Thomas asked whether the standards regulators set forth on this issue were insufficiently clear, counsel for Ruan replied that the elements of knowingly and intentionally misprescribing are left to states and administrative boards, as there is no clear federal guidance on this issue.

For the Justices, this will essentially come down to a question of reasonable professional practice, which can be difficult to pin down in medicine. At least from the nature and tone of the questioning at the oral argument, the Justices seem unwilling to look at the Controlled Substances Act in as restrictive a manner as the Eleventh Circuit did. While pinning down a reasonable good-faith defense is going to be a real challenge for the Court, the outcome here relies upon it, as does intelligent and balanced enforcement of the Controlled Substances Act.

The importance of this case and the underlying issue — the opioid crisis — cannot be overstated. A recent position paper by the American Medical Association made it clear that the nation’s opioid and drug overdose epidemic continues to worsen with metrics far beyond earlier projections. The ruling in this case could impact its trajectory.

While both the Alabama Federal Court jury and the Eleventh Circuit convicted Ruan for violating provisions of the Controlled Substances Act, among other laws, the larger question goes far beyond the wrongdoing of any doctor who may have been motivated to prescribe opioids for financial gain.

Simply put, a doctor’s ability to practice medicine properly would be limited by an inability to make judgment calls. If doctors fear huge penalties for honest mistakes, they will err on the side of not treating. So, if the Court’s ruling sets forth an overly restrictive policy aimed at the small number of physicians motivated by their own self-interest, it may be patients in pain who suffer in the long run.

Will the Supreme Court overturn the Eleventh Circuit here? In my opinion, they absolutely need to. While ensuring the availability of opioids may seem counterintuitive in a national opioid crisis, this is neither the legal nor medical issue presented in this case. Having the Controlled Substances Act without a good‐faith defense makes no sense from a legal or practical perspective. If the Supreme Court doesn’t overturn the Eleventh Circuit, they are essentially saying the binary between good doctors and those who run illegal pill mills is always crystal clear.

We can still be against pill mill doctors but agree that, in all jurisdictions, doctors need the legal ability to follow their best medical judgment to prescribe or not to prescribe as they see fit. If doctors are overly fearful of the legal consequences of perceived misprescribing — which may be the result of the current ruling in the Eleventh Circuit — patients in chronic pain will suffer unnecessarily. Beyond being fundamentally unfair, it is also a specious medical argument for any court to hold that physicians should still be convicted for unlawful distribution of controlled substances if they sincerely believe they were prescribing the drugs under acceptable standards of practice.