PAYBACK: tracking the opioid settlement cash

Payback: Tracking the Opioid Settlement Cash

 

The Tobacco Money Settlement is running out soon. Just about EVERYONE has their HAND OUT for some of the Opioid Settlement Money. From bureaucraties that had employees who are/were dealing with addiction and wants to recoup the money paid out for treating those employees, to Grandparents raising their Grandkids because their parents OD’d and they want financial assistance in raising their Grandkids.  Doesn’t Social Security pay kids $$ when a parent dies?

Not to mention the bureaucracies that the bureaucrats are creating to manage the distribution of those funds.

The total money that is to be paid out over the next 18 yrs, is but a drop in the bucket as to what the Tobacco Settlement amounted to. What industry is next?

Maybe they will go after the Tobacco wholesalers & retailers that didn’t get “taken to the cleaners” with the original settlement? There is always the Liquor industry, but will they sue those states that only sell liquor thru state-owned stores?

I am sure that they will find some other industry that is selling some legal product that they can fabricate some harm to people or with the current “green mindset”, products that “they” believe is harming our environment.

Maybe these law firms and bureaucrats have created a qazi  Rube Goldberg machine https://en.wikipedia.org/wiki/Rube_Goldberg_machine or a qazi “ATM machine” that never runs out of money!

One thing that no one wants to talk about is all this money that is being paid out or has been paid out from the Tobacco Settlement, These tobacco companies are still around and the price of their products are substantially higher than they were back in 1999, way above what the CPI/COLA increases would suggest.

Same thing with all these Opioid fines and settlements that started in the early 2010 decade and now will continue into the 2040 decade. While the DOJ/DEA & state AG’s are attempting to reduce the number of controlled meds produced and sold.

 

Driving down health care costs: Independent pharmacies, patients and lawmakers take steps to rein in PBMs

Driving down health care costs: Independent pharmacies, patients and lawmakers take steps to rein in PBMs

https://spectrumnews1.com/oh/columbus/news/2024/04/03/pbm-ohio-independent-pharmacy

WASHINGTON, D.C. — Even as prescription drug costs have skyrocketed in recent years, Hart Pharmacy in Cincinnati is getting less money per prescription, costing the pharmacy tens of thousands of dollars each year. Third-generation pharmacist and owner Sarah Priestly said costs associated with PBMs forced her to cut back hours for her staff of 16.

“For now, we’re OK, but we’re making harder decisions than we’ve ever had to,” Priestly said.

Pharmacy benefit managers, or PBMs, are companies that control access to prescription drugs by negotiating drug prices with drugmakers and deciding how much insurers pay pharmacies for medicines and services.

PBMs have become an integral but poorly understood component of the American health care system.

 


What You Need To Know 

    • Pharmacy benefit managers, or PBMs, play a large role in the American health care system
    • A growing chorus of pharmacists, patients and lawmakers claim PBMs seek to maximize their own profits rather than drive down health care costs
  • Congress and the Ohio Attorney General are taking measures to enact stricter PBM regulations

They were designed to bring down health care costs. Drugmakers want their drugs listed on PBMs’ formularies, which determine which drugs are covered by insurance. Pharmacies want to be listed in-network, which gives them access to more patients. In exchange, both agree to offer discount on drug prices.

A growing chorus of pharmacists, patients and lawmakers claim PBMs instead seek to maximize their own profits.

Ohio Attorney General Dave Yost said he gets several calls a week from patients and independent pharmacists struggling due to PBM policies.

The heart of the issue, Yost said, was the market dominance of three major PBMs: CVS Caremark, Express Scripts and Optum. Together, the three hold 79% of market share.

All three companies are linked to their own respective insurance company and retail  or online pharmacy.

This concentrated influence has allowed PBMs to increase their profits at the expense of patients and independent pharmacies, Yost alleged.

“It’s like an old river in an industrial city. Every year after year after decade after decade there’s more sediment, there’s gunk that went into the river that sinks down on the bottom. Pretty soon all you’ve got left is gunk and hardly any water. The only way to fix it is to dredge it out and start over. That’s where we are with our healthcare system when it comes to PBMs,” Yost said. “They are adding complications and burdens to the system that are adding no value and driving prices up.”

Yost filed a lawsuit in 2023 against seven PBMs, included Express Scripts, for allegedly price fixing prescription drugs via a Swiss company.

“In our lawsuit, we accuse them of sharing information overseas amongst themselves that is actually having an anti-competitive impact here in America,” Yost said.

The case is currently in legal limbo after the PBMs sought to move the case from state court to federal court, then get it dismissed. In January a U.S. District Court judge denied the motion to dismiss and moved the case back to state court. The defendants appealed the ruling to the U.S. Circuit Court of Appeals, where no hearing has yet been scheduled.

Yost soon tried another tactic to rein in what he calls the “nefarious tactics” of PBMs. On Feb. 20 he led a coalition of 39 attorneys general calling for stricter federal PBM regulations.

The letter urged Congress to act on several pieces of legislation that would require more transparency in PBM transactions, delink PBM fees from drug prices and ban PMBs from compensating certain pharmacies differently for the same drugs, among other measures.

Several of those measures cleared two Senate committees to be included in the 2024 federal budget appropriations bills, but disagreement between House and Senate Republicans on the scope of the measures led to them getting sidelined, likely until a lame duck session after the November elections.

Rep. Greg Landsman, D-Ohio, is working on a more modest bill that he believes can pass more quickly with bipartisan support. The Medicare PBM Accountability Act targets spread pricing, in which PBMs charge insurers a higher amount for a drug than is reimbursed to the pharmacy. The bill would require PBMs to disclose the profit they make on prescription drugs for seniors.

“It requires the kind of transparency that anyone would expect,” Landsman said. “So that when you are buying and selling prescription drugs and you’re putting it on the market, are you getting kickbacks? Are you seeing savings and are you passing those on to shareholders as opposed to seniors? And if you are, we’ve got to put an end to it.”

PBMs are pushing back against stricter regulations. The industry group Pharmaceutical Care Management Association (PCMA) spent $15.4 million on lobbying last year.

Landsman said he was not deterred by industry pressure.

“The TV commercials get me even more determined to get this done because if you have that kind of money—millions and millions of dollars to spend on TV commercials—that means you could be passing on those savings,” Landsman said.

Express Scripts and Optum did not respond to a request for comment on allegations made in this story. CVS Caremark referred the request for comment to PCMA, which did not respond.

Court Rules Against Pharmacist Who Refused Emergency Contraception Prescription

Could a chronic pain pt, who lives in Minnesota, could they sue for being denied controlled Rxs to treat their pain, because they are disabled? After all, maintaining and optimizing a pt’s QOL is time-sensitive!

Court Rules Against Pharmacist Who Refused Emergency Contraception Prescription

https://www.medpagetoday.com/pharmacy/pharmacy/10942

Case will be appealed to state Supreme Court or returned to district court

The Minnesota Court of Appeals has ruled that a pharmacist who refused to provide emergency contraceptives to a customer because of his personal beliefs engaged in discrimination.

The three-judge panel ruled Monday that pharmacist George Badeaux engaged in business discrimination in 2019 when he wouldn’t fill a prescription for an emergency contraception that is used to stop a pregnancy before it starts. The customer seeking the prescription said she then traveled about 100 miles (160 kilometers) round trip from the pharmacy in McGregor to another pharmacy in Brainerd, where she filled the prescription.

The customer, Andrea Anderson, later filed a lawsuit claiming discrimination under Minnesota’s Human Rights Act.

“Badeaux’s refusal to dispense emergency contraception because it may interfere with a pregnancy is sex discrimination,” Judge Jeanne Cochran wrote in the ruling.

The appeals court decision means the case will either be appealed to the Minnesota Supreme Court or returned to district court, where a jury in 2022 found the pharmacist had not discriminated but that Anderson was owed $25,000 because of emotional harm. However, Anderson couldn’t collect that money because there was no finding of discrimination.

Jess Braverman — an attorney for Anderson and the legal director of Gender Justice, an advocacy organization for gender equity — said this may be the first ruling in the country to find that a refusal to dispense emergency contraception is a form of sex discrimination. Alison Tanner, senior litigation counsel for reproductive rights and health at the National Women’s Law Center, agreed.

Braverman said the ruling made clear to Minnesota businesses “that you can’t just turn away patients in need of reproductive healthcare.”

Rory Gray, senior counsel at Alliance Defending Freedom, a Christian advocacy group, represented Badeaux and criticized the decision.

“As a devout Christian, George believes every human life has value. As such, George cannot provide or facilitate the use of any potential abortion-causing drugs,” Gray said in a statement. “The court failed to uphold George’s constitutionally protected freedom to act consistent with his beliefs while at work.”

Anderson tried unsuccessfully to buy the emergency contraception, called Ella, at the drug store. The store previously was owned by Aitkin Pharmacy Services, and an attorney for the business did not immediately respond to requests for comment by phone and email.

Gender Justice appealed the jury’s ruling last year, arguing that Badeaux discriminated against Anderson on the basis of her sex when he refused to fill her prescription for a drug that is only prescribed to women.

In 2015, Badeaux refused to dispense Plan B, a different type of emergency contraception, to a woman, resulting in a complaint to the pharmacy’s owner, the judges wrote. The owner and Badeaux then developed a plan for dispensing emergency contraception, which involved getting another pharmacist to come in to fill the prescription the same day or the next day, or transferring the prescription elsewhere.

Tanner, at the National Women’s Law Center, said the Monday ruling “is important because there should be no reason that folks who are in need of emergency contraception are delayed access to that care. It is a time-sensitive medication.”

Since the U.S. Supreme Court ended constitutional protections for abortion in 2022, some states have expanded access to emergency contraceptives and birth control while other states have restricted access and enacted abortion bans.

Dozens of universities across the country now carry emergency contraceptives in vending machines according to the American Society for Emergency Contraception. Some, such as the University of Tulsa in Oklahoma, are in states where abortion is largely banned

Although Minnesota has protected abortion access neighboring states have banned or severely restricted the procedure.

Bill that would allow medical professionals to deny care based on conscience clears hurdle in House

Bill that would allow medical professionals to deny care based on conscience clears hurdle in House

https://www.newsfromthestates.com/article/bill-would-allow-medical-professionals-deny-care-based-conscience-clears-hurdle-house

House Bill 303, which would allow medical professionals to refuse medical service based on conscience, passed second reading 65-35 in the House on Monday.

“I’d like my health care provider to have a conscience,” said Rep. Steve Gunderson, R-Libby, in support of the bill.

Sponsor Rep. Amy Regier, R-Kalispell, said on the floor that the bill, which will need to pass third reading before heading to the Senate, was aimed not at particular persons, but at procedures, as she had in committee. She listed objections “concerning lifestyle, elective procedures and treatments,” like assisted suicide, gene editing, dispensing marijuana or opioids and abortion.

However, several Democrats spoke in opposition to the bill, the first being Rep. Zooey Zephyr, D- Missoula, the first trans woman elected to the statehouse who serves on the House Judiciary Committee where the bill was heard last week. Medical professionals and organizations had opposed it in committee.

Zephyr said Regier’s characterization the bill was focused on procedures and not people doesn’t accurately reflect its broad language, including definitions for health care service that span from research to any service performed or provided by a medical practitioner.

Zephyr spoke to the impact the bill could have on the trans community, as she and advocates did in committee. She said that the likely consequence would be denial will be based on diagnosis.

“That is inherently discriminatory, because you cannot parse my diagnoses from who I am,” she said. “To deny me based on my diagnosis of gender dysphoria is to deny me based on my being a trans woman.”

Proponents said the bill allows medical professionals to live their values, with Regier citing it as a way to help retain healthcare workers in the state.

Rep. Jerry Schillinger, R-Circle, said in an “oftentimes profit driven world,” healthcare providers who hold traditional values need protection.

Rep. Laura Smith, D-Helena, said she was rising in opposition to the bill due to the impact on parental rights. She said parents would have less ability to advocate for family members in the hospital, giving the example of a family advocating for an unconscious patient where medical staff initially denied a procedure to help her breathe due to concerns over suffering. In Smith’s telling, the young girl made a full recovery after the family pushed for care.

“I think we all have to be honest with ourselves that this is not something that couldn’t fall upon any of us in our lives, our kids or our grandkids,” Smith said.

Rising as a proponent, Rep. Kerri Seekins-Crowe, R-Billings, said her healthcare provider stopped providing service to her after a vote she had taken during the 2021 session on wolves.

“And even though it was a blow to me, because I really did like the healthcare I was getting from her, I really do believe …that she has the right to not to give me care if she believes that strongly,” she said. “Her oath of ‘do no harm,’ she can no longer uphold that if that’s what she believed in.”

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

This test could be a very slippery slope for this company and any practitioner who uses it and its results. Addiction has substantial underlying mental health issues. Mental health issues are all pretty much subjective health issues and can be various subsets of the total mental health spectrum.

What happens when a pt shows a “positive” test result and is not given or taken off their opioid pain meds, and the pt suffers health consequences for under/untreated pain?

On the other side, the pt shows a “negative” test result and is given opioids for their pain, and they end up becoming an addict because the negative ended up being a false negative.

I suspect that some entity is going to be sued for damages, will it be the pharma or the prescriber who ordered the test?

I hope that the FDA takes the recommendation of its committee of experts and withdraws this test from the marketplace. Of course, FDA is protected by sovereign immunity from being sued for any damages.

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

https://www.medpagetoday.com/neurology/opioids/109508

Methodology behind AvertD DNA test questioned

A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD).

In a letter to FDA Commissioner Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device regulation asked the agency to revoke its recent approval of AvertD, based on research that doesn’t support the methodology used by the test’s sponsor.

The group also sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking CMS to deny coverage of AvertD.

The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon.

AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The major risks associated with AvertD are false-negative and false-positive results, the FDA said. Before the agency approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

“The FDA seems to believe the test isn’t a very good test but that it’s better than nothing. They’ve got it wrong,” said Andrew Kolodny, MD, an opioid policy expert at Brandeis University in Massachusetts, who signed the letters to the FDA and CMS.

“The problem isn’t that the test has weak specificity and sensitivity,” Kolodny told MedPage Today. “The problem is that it doesn’t work at all. It’s 100% bogus.”

The AvertD test will harm people, Kolodny emphasized. “Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction,” he said.

“Patients who test positive will be falsely branded as prone to a highly stigmatized condition,” he continued. “And they may become fearful of taking opioids, even in situations where use is beneficial.”

Genetic tests for opioid addiction have a checkered history. The FDA approval of AvertD last year was an industry first.

Like many genetic tests, confounding is part of the problem, Kolodny and colleagues said. An independent evaluation using methodology like the one used to test AvertD found that the algorithm gave the appearance of predicting genetic risk but was not a true measure of genetic risk, they noted.

“With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance,” they said in their letters to the FDA and CMS.

SOLVD Health said it was aware of the letters to FDA and CMS and is reviewing them.

“We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid-sparing techniques or alternative pain management options, if medically appropriate,” the company said in an email to MedPage Today.

“Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multicenter study evaluating participants at least 1 year after their initial exposure to prescription oral opioids,” SOLVD noted. “In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder.”

The company also said it is conducting prospective post-market studies to further evaluate the test’s performance in real-world settings.

Death because of GREED? Wisconsin family speaks out against PBMs after the loss of their son

I remember reading a story- many years ago – about a young man who was a brittle type-1 diabetic. He had called his refill into his pharmacy- mid-week- to get refilled and while the Rx had indicated two refills remaining, it was over 1 yr old and the refills had expired. The pharmacist requested for more additional refills for this guy’s insulin from the prescriber.  This young man came in on a Saturday or Sunday to pick up his refill, but the prescriber’s office had never followed thru on authorizing more refills.  The Pharmacist informed the guy this and the Pharmacist declined to refill the guy’s insulin Rx. A day or so later this fellow DIED, just because no one did their job.

The last contract that I worked under was to help turn around a large company that provided nursing homes with respiratory and other needs. The owner had suffered a serious brain clot/stroke and was incapacitated and eventually died. One of the older employees was a type-1 diabetic and was having trouble affording his Insulin. He was “rationing” his insulin. I printed out this website https://www.rxassist.org/ and gave it to him. He came back to my office a few days later, telling me that he had contacted this website and they were going to send him THREE BOTTLES OF HIS INSULIN, and they were going to continue providing him his insulin going forward. I don’t remember if it was going to be sent to him free of charge or for a very inexpensive cost, that he could afford. Needless to say, he was very happy.

 

Wisconsin family speaks out against PBMs after the loss of their son

https://www.wjfw.com/news/wisconsin-family-speaks-out-against-pbms-after-the-loss-of-thier-son/article_489e5590-e003-11ee-ae20-fb51d5ece985.html

Cole Schmidtknecht was a 22-year-old young man living in Appleton, Wisconsin who loved video games and sports. His parents Bil and Shanon described him as an inspirational free spirit with a love for being heard.

“He was definitely one of a kind,” said Shanon.

Cole was diagnosed with severe asthma at only a year old. He had just recently moved out on his own with opportunities to chase his dreams, until his life was cut short earlier this year.

“January 10th,, he went to the pharmacy to get his prescription and was told it was no longer covered by his insurance,” said Shanon.

He was told there was no alternative option and no generic drug would be covered. Cole didn’t know how to respond and couldn’t cover the extreme out-of-pocket cost of his Advair inhaler on a $19/hour income. An inhaler-dependent patient left the Walgreens Pharmacy with no medication. Five days later he suffered an extreme asthma attack and was taken to the hospital. He arrived at the Emergency Room lifeless and spent the next six days in the ICU on a ventilator.  

“We were told he’s never going to wake up again,” said Bil.   

A generic version of Advair only costs $15-$20. What happened to Cole is happening all over the country, according to Hometown Pharmacy co-founder Dan Strause.

“Unfortunately, we see even the state plan now no longer will allow for the generic, they force people into the brand. Why? It’s not hard to figure out it must be about the profit margin. Unfortunately, they’re making people decide between life-saving medicine [and paying bills, even though] the cost of the actual item is so low,” said Strause.

“We find this absolutely wrong, its infuriating we should all be angry, and we hope you tell your legislators this needs to be addressed sooner than later,” said Strause.

Hometown Pharmacy had to close a location in St. Germain partially due to the influence of PBMs. A pharmacy benefit manager acts as a middleman between drug manufacturers and pharmacies.

In the last state legislative session, the pharmacy benefit manager regulation bill wasn’t brought to a vote. The bill was designed to create transparency in the system and prohibit the PBMs’ control over the pharmaceutical industry as a whole.

“We’re very frustrated that it never got a chance to be voted upon,” said Strause.

Strause said there is a lot of speculation as to why the bill didn’t make it to the floor.

“In politics, there’s a lot of moving parts and we believe that the recent vote for Wisconsin mapping is part of it, because there’s a lot of energy and focus with what the next election is going to be and of course elections are very expensive, and you have to fund those elections.

Strause believes that money from lobbying groups associated with PBMs have a strong influence on lawmakers.

“Unfortunately, it means that money and influence is a significant factor in us passing bills especially ones that affect all of our lively hoods and our health,” said Strause.

Bil and Shanon said after learning of PBMs and the tactics that cost them their son they were angry and decided it was time to speak up.

“I don’t want you to ever have to imagine, I don’t want anyone to ever have to experience this,” said Shanon.

Their goal is to share Cole’s story and raise awareness.  

“We just kind of feel like this is now our fight to fight for him. If we can prevent it for one other person just that alone would be a little solace or a little something I know we can never have our son back, he’s gone,” said Bil.

Cole’s situation is not the only one, and this could happen anyone. Everyday life saving medications are becoming inaccessible to patients who need them.

“We need our senators and our congressmen to help this process that’s why they’re there in office for our complaints, our concerns our needs and the games that are played are just costing lives,” said Bil.    

HHS Cracks Down on Care Facilities for Failure to Turn Over Medical Records

HHS Cracks Down on Care Facilities for Failure to Turn Over Medical Records

https://www.medpagetoday.com/special-reports/features/109455

Office for Civil Rights fines two facilities that stalled on giving access for more than 100 days

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has settled two cases involving healthcare facilities that failed to provide timely access to medical records.

OCR announced settlements with Essex Residential Careopens in a new tab or window in New Jersey (doing business as Hackensack Meridian Health, West Caldwell Care Center) and Phoenix Healthcareopens in a new tab or window in Oklahoma (doing business as Green County Care Center).

Both care facilities failed to provide medical records to a patient’s personal representative within 30 days as mandated by the Health Insurance Portability and Accountability Act (HIPAA), OCR stated.

“It is unacceptable for a healthcare provider to delay or deny requests to release medical records for months, and we are calling on providers everywhere to be compliant to help empower patients,” OCR director Melanie Fontes Rainer, JD, said in a statement.

On Monday, OCR announcedopens in a new tab or window that West Caldwell Care Center (WCCC) — a skilled nursing facility that provides long-term care and rehabilitation services — would have to pay a $100,000 penalty for not providing timely access to patient records.

According to the agency’s notice of final determination, Peter Lindsay requested a copy of his mother’s medical records from WCCC via email. His request was denied on April 22, 2020, and an administrator asked for a copy of his power of attorney, medical proxy, or similar document signed by his mother, Lois Lindsay, establishing him as her representative.

Peter Lindsay sent the power of attorney via email on April 23, 2020, but still didn’t receive any records. He filed a complaint with OCR on May 19, 2020, alleging WCCC and its parent company failed to give him access to his mother’s medical records, even after providing proof of his status as her representative.

Peter Lindsay finally received a copy of the records on Dec. 1, 2020, as a result of an OCR investigation — 161 days after his initial request, the determination stated.

Late last week, OCR announced that Phoenix Healthcare in Oklahoma will pay $35,000 to settle claims that it didn’t provide access to patient medical records in a timely fashion.

In this case, a daughter who was not named filed a complaint with OCR alleging that Phoenix Healthcare wouldn’t give her access to medical records for her mother as her representative.

After attempts at “technical assistance” and “attempts to get the records by OCR,” the facility provided the records on Jan. 30, 2020 — 323 days after the initial request, according to an OCR press releaseopens in a new tab or window.

“The Office for Civil Rights continues to receive complaints from individuals and personal representatives on behalf of individuals who do not receive timely access to their health records,” Fontes Rainer said in a statement. “OCR will continue to vigorously enforce this essential right to ensure compliance by healthcare facilities across the country.”

Is your family in a financial death spiral?

Recently on one of the Financial TV shows, one of their “talking heads” stated that the USA is not using the same basket of goods to calculate our COLA/CPI as was used during the Jimmy Carter presidency. He stated that if we currently use the same basket  of goods as during the Carter Admin the peak increase in the CPI to 8.5% in March of 2022, would have been ~ 17%.https://www.newsweek.com/fact-check-has-inflation-gone-every-month-joe-bidens-presidency-1712159  

If you wish to use this comparison chart, you will have to go to this hyperlink to get it to make it function.  https://www.biden-mart.com/  The data is based on USDA data.

It is claimed that 60%+ of households are living paycheck to paycheck and the typical family cannot afford an unexpected $500 bill, and the total consumer debt on credit cards has passed ONE TRILLION DOLLARS for the first time. Some credit card companies are charging interest rates upwards of 30%. It seems that all too many families are in a financial death spiral.


Killing Them Quietly

Killing Them Quietly

https://www.daily-remedy.com/killing-them-quietly/

Government versus Medicine

A war is raging in America today, between physicians treating pain and addiction, and the United States federal government (mostly the DEA) on the proper practice of medicine. While the federal government is forbidden by law from trying to influence the practice of medicine, according to Lambert v. Yellowly, 1926, where the Supreme Court ruled that “direct control of medical practice in the States is beyond the power of the Federal Government.” Based on Linder v. United States, 268 U.S. 5, 18, where it was ruled that “Congress, therefore, cannot directly restrict the professional judgment of the physician or interfere with its free exercise in the treatment of disease. Whatever power exists in that respect belongs to the states exclusively.”

This was followed by a Medicare statute, 42 USC 1395, that expressly forbade the federal government from interfering with the practice of medicine, stating: “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.”

These precepts were further affirmed by the US Supreme Court in Gonzales v. Oregon, where the US Supreme Court forbade the US Attorney General from enforcing the Controlled Substances Act against physicians who were prescribing medications in accordance with state law. In this case, the state of Oregon had passed legislation allowing physicians, in very narrow circumstances, to prescribe a medication for the express purpose of ending someone’s suffering by ending their lives. As of that lawsuit, 935 people had exercised their right under Oregon law, to end their suffering under their own terms, and the physicians had been protected from prosecution. The AG threatened to prosecute the doctors, and the physicians sued, eventually ending up in front of the Supreme Court and winning.

Then we had Xiulu Ruan v. United States. Where two physicians had been prosecuted for being “outside the usual practice of medicine” and prescribing controlled substances “without a legitimate medical purpose.” These ill-defined concepts heretofore being left to the government’s creation out of whole cloth. In this case the trial court b had instructed the jury that the doctors’ subjective belief that they were acting in good faith didn’t matter if the government was able to persuade the jury that the doctor’s practice deviated from “the norm.” According to one government expert in sworn testimony the norm exists only in the minds of government experts and cannot be found in any book or database. After the physicians were convicted their appeal ended up in front of the US Supreme Court.

The Court immediately saw the injustice in the government’s argument, stating that the law was ““ambiguous,” written in “generalit[ies], susceptible to more precise definition and open to varying constructions.” Further ruling that, without mens rea, a “vicious mind”, and clear knowledge of wrongdoing, a physician should not be declared criminal. This comports with a long held precept of American law that a serious crime requires proof the person knew what they were doing was wrong and did it anyway. The Court also ruled that the doctor should not have to prove that their mental state was that of a “hypothetical ‘reasonable’ doctor.” Finding that “…for purposes of a criminal conviction under §841, this requires proving that a defendant knew or intended that his or her conduct was unauthorized.”

That should have settled matters, but it did not. It is not common for the executive branch of the United States of America to refuse to follow the judicial branch’s interpretation of the law. In fact, I can find only two examples of this happening. The first of these was in 1832, in the case of Worcester v. Georgia. This case involved the Cherokee Nation, which had adapted better than most Native American tribes to life in the new American nation. They had developed a written language, and newspapers, and many had sent their children to universities and even law school. When the state of Georgia tried to control lands guaranteed to the Cherokee by treaty, they met fierce and eloquent opposition, and the US Supreme Court rule that the states did not have the right to impose regulations on Native American land. But the current president, Andrew Jackson, refused to enforce that ruling, saying of Chief Justice Marshall, “Now let him enforce it.” and refusing to protect the rights elucidated by the Supreme Court The states eventually seized most of the land set aside for Native Americans by treaty, leading eventually to the Trail of Tears.

The first Trail of Tears in 1838 had a 27% mortality rate, resulting in the deaths of 4,000 Native Peoples on that first death march. The states were so pleased with that result that they did it repeatedly over the next decade and a half. Eventually killing more than fifteen thousand and displacing over one hundred thousand. Today, there is a new Trail of Tears being created, by the DEA’s refusal to honor the ruling of the US Supreme Court in Ruan. Doctors are being prosecuted for the non-crimes of prescribing “dangerous medications in dangerous combinations,” (which is the very definition of what distinguishes a physician from every other profession…) to patients who “travel long distances for treatment.” Of the twelve listed “pill mill” descriptors pried from government records. None are crimes. In many cases, the government does not try to prove or even allege that the doctor had criminal intent, arguing only that he was “willfully blind” to the nebulous standard espoused by a medical expert witness of doubtful qualification, who has been paid to advance their opinion and convince the jury.

The government is pursuing a theory that the prescribing of opiate medications led to the current opioid epidemic. Nothing could be further from the truth. In the early 1990s it was recognized that untreated chronic pain reduced the quality and shortened the lives of those suffering from it. While pain itself is sometimes argued to not be fatal, this argument would instantly be recognized by any Civil War physician as inconsistent with evidence based medical practice. Without adequate analgesia, the simple amputation of a limb was found to cause death by shock if it took longer than fifteen minutes. Not from blood loss mind you. This was controlled by a tourniquet. But instead from the severe pain causing the heart to fail. It has been proven that even the psychological pain of a broken heart can have this effect. The proof that pain was causing death can be found in modern operating rooms, where, with the use of modern anesthetics, patients can survive hours of surgery without cardiac failure.

Severe chronic pain damages the heart by increasing sympathetic nervous system activation, increasing cardiac contractility and blood pressure, causing the heart to be overworked, predisposing it to arrhythmia and dysregulation of cardiac function. Chronic pain also increases stress hormone levels which increase the inflammatory response. Over time this leads to cardiac stress and arterial endothelial dysfunction and plaque formation, leading to coronary and arterial occlusion that causes heart attacks and strokes. A study in published by Harvard Health showed that people with chronic pain are 20% more likely to have a heart attack and 30% more likely to have a stroke, adjusting for factors like diabetes etc. These facts have long been well understood by the medical community, and treating chronic pain to make it tolerable was considered a basic function of primary care medicine.

By the early 2000s several states had passed pain treatment acts protecting physicians who treated pain from prosecution, recognizing that family and law enforcement may not understand the practice of medicine well enough not to blame a physician for any bad outcome. Leaving it to the state medical boards to police the practice of medicine, suspending or revoking a physician’s license under their state appointed authority. Opiate medication prescriptions peaked around 2012, as physicians sought to balance the need to control pain with the need to prevent overuse, addiction, and diversion. Then came the Fentanyl epidemic, where uncontrolled border checkpoints allowed a nonstop flow of this extremely potent opiate into the country. Since the early 1900s, heroin, invented as a “nonaddictive” treatment for morphine addiction, was the major opiate of abuse in America.

Heroin is bulky and hard to smuggle, but fentanyl, being much more potent, could have the same effect in milligrams that took kilograms of heroin. Hiding thirty pounds of something can be tough. Hiding three ounces is a lot easier. But fentanyl wasn’t well known on the black market, so the drug dealers used it to make fake heroin. If they had carefully calibrated the fake heroin to have the same potency as real heroin, the overdose rate would not have changed, but that’s asking too much of people who smuggle and deal drugs. Invariably they would put in too much, and people who thought they were taking there usual dose would die. This led to a sharp spike in fentanyl related deaths starting in 2013. Since fentanyl CAN be prescribed, every one of these deaths was initially reported as a prescription opiate related death. Even though comparing the rates of prescribed fentanyl to the death rate proves there is no correlation whatsoever. In 2018, the US Bureau of Vital Statistics was forced to correct its methods, reducing the number of deaths involving prescription drugs by at least half.

Fentanyl is very rarely prescribed to persons without cancer except in a patch form that is hard to abuse and not related to any significant overdose risk. As the deaths related to Fentanyl continued to climb, reaching 9,580 in 2015, the federal government saw an opportunity to intervene, and the CDC wrote the now somewhat infamous guidelines on prescription of opioids to adults with chronic pain. What started as a simple caution to primary care providers to be careful at certain levels of pain medication treatment, became a mandate to limit pain management, and finally, even a weapon to use against board certified pain specialists. With this cudgel in hand the DEA rapidly began prosecuting any physician who was perceived to be outside the limits of prescribing as defined by the CDC. States got in on the act, suing pharmaceutical companies for excessively promoting pain medications and creating laws in line with the CDCs guidelines.

As acknowledged publicly by the CDC in 2018, the problem was that these guidelines were never meant to become mandated limits on physicians. They were supposed to be just a reminder to be cautious. It is not that the guidelines were completely without merit, it’s that they were concocted without any real evidence and deeply influenced by anti-opioid bias. As some have acknowledged on video, there was not time for evidence, opinion would have to suffice. Opinion is fine when the professional is free to make exceptions. However, it becomes a government enforced ideology when they are not-which is precisely what the DEA has done. Physicians’ offices were raided, and the doctors paraded to the public as if they were Pablo Escobar. This witch hunt turned out to be a windfall for the federal government, as they seized physicians’ assets and made headlines, all the while avoiding the real drug dealers who might shoot back. For every doctor prosecuted, over a thousand patients were left stranded.

Following its unjustified persecutions of particular doctors, the DEA would then monitor these patients to see where they went, targeting doctors who accepted these medical refugees as patients. One needs only look at the tragic suicides of Daniel and Gretchen Elliot in 2022, when their doctor, Dr. Sachy, was targeted and shut down. Fleeing to Dr. Bockoff just set that doctor up for targeting. When Bockoff was shut down no one would treat them. Gretchen and Daniel took their lives together when his pain became intolerable, and his loss was more than she could bear. Now the formula for a perfect storm was complete. Heroin addicts overdosing on fentanyl which was then reported as a prescription medication death led to the targeting of doctors which in turn led to chronic pain patients having nowhere to go, sending them to the streets searching for medications. Which created the perfect opportunity for true “pill mills”.

A real pill mill is where fake pills made to look exactly like hydrocodone or oxycodone are made using pill presses that can be purchased online. These pills fooled the abandoned patients, who rapidly died of an overdose when the fentanyl level was too high. These were also reported as prescription related deaths. The DEA tried to shut these down with limited success, but this was hard and they were under pressure. So they started calling any practice that treated a lot of pain patients a “pill mill” something that judges routinely allowed them to repeat in court.

Let’s put some things in perspective. There were 336,997,624 people in the United States in 2021. During that same year 3,458,697 people died. That’s almost exactly 1%, 1.03% in fact. Of those deaths, 107,622 involved drug overdose. That’s 3.1% of all deaths. Stimulants like methamphetamine and cocaine accounted for another 26,806 deaths, sometimes overlapping deaths where opioids were involved. 88% of opioid involved deaths were due to illegal fentanyl-about 75% of all deaths involving a drug of any type. Almost NONE of this fentanyl comes from prescriptions. Fentanyl is used almost exclusively in the hospital, surgical, and emergency environments. It is extremely rare to get an outpatient fentanyl prescription, and these are usually reserved for cancer patients. Most remaining opiate related deaths are associated with heroin.

In that same year, from the DEA press release website, I can immediately find eighteen cases of doctors being shut down or sent to prison. Many of these were for prescriptions written years earlier, identified by data mining algorithms that target doctors based on the how busy their practice is, how much insurance companies have to pay for testing etc., how far their patients drive, and whether or not they own lake front or beach front property. In 2021 alone, just from these numbers, we’ll have at least eighteen healthcare providers shut down. That leaves about 36,000 people searching for a physician to help them. The DEA is actively tracking patients from a prosecuted doctor and targeting any physician who treats those patients for their pain. A study completed in 2021 found that about 36% of patients could not find any doctor willing to treat their pain, and that study was on patients whose doctor had NOT been targeted. Add all of these to the to that original more than one third of severe chronic pain sufferers that could already NOT find treatment before this madness started.

And what is the result? The DEA acts like cutting people off their treatment or not treating them at all with any effective medication is some kind of solution. It is not. Untreated and undertreated chronic pain sufferers are 20% more likely to have a heart attack and 30% more likely to have a stroke than the general population. They are also more likely to commit suicide. Ten percent of all suicides are linked to severe chronic pain. From my estimates we now have at least 6,156,000 people with severe life-limiting chronic pain that cannot find treatment. What is also not pointed out by the federal authorities, is how many of those patients suffering from untreated chronic pain in a world where it is no longer safe for doctors to treat them, will go to the streets. Finding fentanyl laced fake pills rather than their expected medication. The evidence is clear. In their misguided attempts to stop prescription opiate overdose, which accounts for less than five hundred deaths per year, the US federal government is killing tens of thousands. They may be killing them quietly and indirectly, but those patients are dead just the same.

Encourage patients to submit complaints to Medicare

Encourage patients to submit complaints to Medicare

https://ncpa.org/newsroom/qam/2024/03/27/encourage-patients-submit-complaints-medicare

Patients across the country are facing issues filling prescriptions due to patient steering and PBM network issues. Encourage your patients to reach out to Medicare directly through their online complaint form or call Medicare directly. We’ve added that contact information into a printer-friendly document that you can hand your patient at the pharmacy counter when they experience pharmacy access issues.