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Minnesota seeks $1.25 million fine against CVS Caremark over pharmacy rules

https://m.startribune.com/minnesota-seeks-1-25-million-fine-against-cvs-caremark-over-pharmacy-rules/600168840/

Minnesota is threatening a $1.25 million fine against CVS Caremark, alleging it wrongly steered patients to CVS pharmacies owned by its parent company.

Caremark is a Rhode Island-based pharmacy benefit manager that structures how and where health plan enrollees can use their coverage to obtain medications.

The Minnesota Department of Commerce’s allegations focus on one of Caremark’s programs, called Maintenance Choice, which managed pharmacy choices for about 72,000 state residents using maintenance medicines last year.

Maintenance medications are those used to treat ongoing health problems, such as high cholesterol, asthma, diabetes and heart disease.

After filling their first three maintenance prescriptions, patients were required to use a CVS retail or mail-order pharmacy in which the pharmaceutical benefit manager (PBM) has an ownership interest, the Commerce Department said Thursday in a news release.

In some cases, patients “have needed to drive 20 to 130 miles,” the department said, to reach a CVS location rather than refilling medicines a much closer pharmacy.

“A PBM cannot require or incentivize a covered member to use a pharmacy it owns unless certain other conditions are met, such as providing the same incentives at non-owned pharmacies,” the news release said, “or imposing the same limits at its owned pharmacies as at its non-owned pharmacies.”

Phil Blando, a CVS Health spokesman, on Friday said the company is committed to complying with all laws and regulations that apply to its business as well as clients’ health benefit plans.

“While we maintain that federal laws governing ERISA plans preempt state laws and that the plan designs chosen by our Minnesota client plans are lawful, we are working cooperatively with the Minnesota Department of Commerce on this matter,” Blando said in a statement.

The Commerce Department has initiated a contested case against the company and is trying to stop practices that the department claims are a violation of the Minnesota Pharmacy Benefit Manager Licensure and Regulation Act. A prehearing conference is scheduled for May 31.

The civil money penalty is the largest the Commerce Department has sought thus far under state regulations for PBMs passed by the Legislature in 2019.

Pharmaceutical benefit managers structure the pharmacy portion of health plan benefits. They create networks of pharmacies where patients can get the best deals on medicines while negotiating prices with manufacturers. They also create “formularies” that specify patient copays for different drugs.

Owned by CVS Health, Caremark is one of the nation’s three largest PBMs alongside UnitedHealth Group’s Optum Rx and Express Scripts, which is owned by Cigna. Independent pharmacies have argued that PBM rules make it difficult for them to stay in business.

“This case demonstrates the importance of regulating PBMs in order to protect Minnesotans’ access to the critically important health care that pharmacies provide,” Commerce Commissioner Grace Arnold said in a statement. “The practices uncovered in this case show a corporation placing priority on its own profits rather than serving people.”

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I see with almost every seizures of illegal drugs – typically illegal Fentanyl – just how many MILLIONS OF PEOPLE THAT THE NUMBER OF TABLETS, KILOGRAMS that was in the seizure could kill.  So should anyone arrested in possession of illegal drugs, be charged with attempted murder of the number of murders that the authorities claim those illegal drugs could have caused.  Maybe these people should just have a “quick trial” … found guilty and quickly executed.  I would bet that the supply of drug mules and street sellers of illegal drugs would quickly DRY UP. As the number of drug mules and street dealers drys up, so would the number of people ODing from illegal Fentanyl and other illegal drugs.

Senators Introduce Bruce’s Law to Help Combat Deadly Fentanyl Epidemic

https://www.feinstein.senate.gov/public/index.cfm/press-releases?ID=AFAA4F65-5BBF-48E7-B4A1-989A3478252C

Washington–Senator Dianne Feinstein (D-Calif.) joined Senators Lisa Murkowski (R-Alaska), Dan Sullivan (R-Alaska) and Maggie Hassan (D-N.H.) today to introduce Bruce’s Law, which aims to bolster federal prevention and education efforts surrounding the dangers of drugs laced with fentanyl, an incredibly powerful and deadly synthetic opioid. 

Bruce’s Law is named after a native of California and Alaska, Robert “Bruce” Snodgrass, who passed away from a fentanyl overdose in 2021. The bill also authorizes new Community-Based Coalition Enhancement grants to help educate young people about the risks of street drugs laced with fentanyl. This would allow Drug-Free Communities Coalitions to access new funding focused on fentanyl to try to curb its use. 

“Fentanyl kills more Americans than any other drug, and it takes only a small amount to cause to a fatal overdose. As more fentanyl is being mixed into illicit drugs, it’s important that all Americans are aware of the prevalence of fentanyl and the danger it poses,” said Senator Feinstein. “This bill will help expand awareness campaigns and create a more coordinated federal interagency effort to reduce overdose deaths.”

“We cannot stand idly by and allow the fentanyl epidemic to wreak havoc on individuals, families, and communities across our state,” Senator Murkowski said. “The passing of Bruce Snodgrass was heartbreaking and all too familiar. I continue to read headline after headline in our local press – and directly from Alaskans who are impacted – about the fentanyl crisis intensifying. We also know that we’re not alone, that this is a national crisis, and that we need to do more. We have an opportunity to help change that through this legislation. I thank advocates like Sandy Snodgrass and all of the individuals who helped us craft this bill, and urge my colleagues to swiftly take up and pass it.”  

“On October 26, 2021, my 22-year-old son, Bruce, died by fentanyl poisoning in Anchorage, Alaska. Since that day, I have learned that the amount of fentanyl that it takes to kill you can sit on the tip of a pencil. Since that day, I have learned that drug overdose, largely due to fentanyl poisoning, is the leading cause of death for Americans aged 18-45. Since that day, I have learned that all illicit drugs in this country need to be suspected of being poisoned by fentanyl. Since that day, I have learned that Bruce was one of nearly 108,000 Americans that died of a drug overdose in 2021, with the majority of deaths due to fentanyl poisoning. Since that day, I have learned that the CDC reports to date in 2022, an American dies every 5 minutes of a drug overdose. Since that day, my sole purpose has been, and will continue to be, to raise awareness and provide education to stem the death toll that fentanyl poisoning is wreaking in our country. Today, I ask all members of Congress to stand with Senator Murkowski, Senator Feinstein, Senator Sullivan and Senator Hassan in support of Bruce’s Law, and to join us in raising awareness and providing education to as many Americans as we can reach, as quickly as we can reach them. Time is not on our side!” said Sandy Snodgrass, Bruce’s Mom. 

“I want to thank Senator Murkowski and Senator Feinstein for their efforts in creating federal legislation regarding the Fentanyl Crisis. This highly lethal synthetic opioid is a scourge plaguing Alaska, as well as nationwide. We know that in a national survey, 59% of youth aged 13-24 hadn’t heard of fentanyl and only 37% believed that fentanyl was dangerous. During 2020-2021, EMS in Alaska responded to 58 suspected overdoses among people aged 0-19 years. Youth need to know opioids ‘hack and whack’ the brain. Opioids ‘rewire’ the circuits in the brain to assign ‘supreme’ value and use of opioids versus health, family, school and work. I believe our youth will make better and healthier choices if they have the necessary information about substances, especially with the acute danger of fentanyl. I strongly urge that ‘upstream primary prevention and drug education’ be an important strategy in Bruce’s Law. This prevention and drug education needs to be current, accurate and honest. Finally, regarding fentanyl, it is not an overdose, which infers too much. But a poisoning, because it only takes 2 mg, which can fit on the end of a pencil! I am in full support of Bruce’s Law to saves lives. We have to cut the flow off into the river of addiction and overdoses. We cannot wait any longer,” said Michael Carson, Vice President & Recovery Specialist at MyHouse of Mat-Su and Chair of Mat-Su Opioid Task Force.

“I’m writing this with a broken heart, an utterly devastated soul, a comment no mother should ever have to write. With tears in my eyes and pleading in my heart I am begging you to do everything within your power to put a stop to this senseless murder of our American children. I fully support the education and resources that Bruce’s Law will bring to our young Americans. You see, I lost my son, Taegge D. Lee on July 15, 2021 to fentanyl poisoning, in other words he was murdered. He was 21 years old, he went to bed and never woke up. We never got to say goodbye, never got a last hug or to tell him just how much we love him and how proud we were of him. Taegge was not a junkie! He was working at an air service in Alaska, had his own home and was saving money for another trip. He was a productive member of society, he was not a thief, he was not lazy, he was a lover of art, poetry, music and nature. He traveled the world with his last adventure taking him to Bali by himself. Sadly, that was his last trip. Please pass Bruce’s Law so no other family has to suffer this extreme loss,” said Julie Bouchard of Palmer, Alaska, Taegge’s Mom. 

Summary of Bruce’s Law: 

• Authorizes the Department of Health and Human Services (HHS) to launch a public education and awareness campaign focused on the dangers of drugs that could be contaminated with fentanyl, drug prevention and detection of early warning signs of addiction among youth. 

• Authorizes the Secretary of HHS to establish a Federal Interagency Working Group on Fentanyl Contamination of illegal drugs, which would:
  • Consult with experts, including family members, youth, and individuals working toward recovery, to help develop opportunities to improve responses to the incidence of drug overdose by fentanyl-contaminated drugs. 
  • Study all federal efforts to prevent and minimize drug overdose by fentanyl-contaminated drugs, and make suggestions to better educate school-aged children and youth on the dangers of drugs contaminated by fentanyl. 

• Authorizes new Community-Based Coalition Enhancement Grants to educate young people on the risks of drugs contaminated with fentanyl. 

Background: 

Last summer, the Drug Enforcement Administration (DEA) issued its first Public Safety Alert in six years, warning Americans about the availability of fake prescription pills containing fentanyl and methamphetamine.  DEA’s alert comes in the wake of a significant rise in overdoses and deaths being caused by counterfeit drugs being mass-produced by criminal drug networks that contain fentanyl.  

DEA also documented a dramatic increase in its seizures of pills containing illicit fentanyl over the past two years. The agency seized more than 9.5 million counterfeit pills in every state during 2021—more counterfeit pills than were seized in 2019 and 2020 combined. According to DEA, “a deadly dose of fentanyl is small enough to fit on the tip of a pencil.” 

Illicit fentanyl is powerful, easily made and easy to transport, making it a popular and profitable narcotic for drug traffickers. Many school-aged children and youth are not aware that the illegal drugs they are using – including heroin, cocaine, methamphetamine, or benzodiazepines – are now statistically likely to contain a deadly dose of fentanyl. 

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Is this another example of one of many middlemen within our healthcare system whereas all involved in providing healthcare are dividing responsibilities as to  what and how much care any particular pt gets and when things GO WRONG.. they can point fingers at each other as to has the ultimate responsibility and until the point that they have all “muddied” the water and the facts so much… it is hard to tell which party/middleman made the real crucial contribution to the final outcome.

Cancer killed Kathleen Valentini, but prior auth shares the blame

https://www.ama-assn.org/practice-management/prior-authorization/cancer-killed-kathleen-valentini-prior-auth-shares-blame

Kathleen Valentini had crucial medical care delayed as she awaited prior authorization from eviCore, a third-party administrator that her health plan contracted with for prior authorization reviews. It was a delay that caused her immense suffering and, ultimately, her life.

Now, physicians tell the court, the company must be held responsible for how its actions affected the patient.

“EviCore asserts that, contrary to its own representations, its duty was only to the insurance companies that contracted with it and not to Mrs. Valentini. EviCore is wrong. Under the New York law of negligence, eviCore had a duty to Mrs. Valentini, and it should be held to its promises. EviCore, not Mrs. Valentini, should bear the consequences of its misrepresentations,” says an amicus brief from the Litigation Center of the American Medical Association and State Medical Societies, the Medical Society of the State of New York, the Vermont Medical Society and the Connecticut State Medical Society to the 2nd U.S. Circuit Court of Appeals.

Physicians at Memorial Sloan Kettering Hospital said eviCore’s delay meant that a less radical, and possibly more successful, chemotherapy treatment was no longer an option for Valentini. By delaying care, her cancer went undetected. She was in pain and her leg, hip and pelvis were amputated. She ultimately died.

“No one can ever know how Mrs. Valentini’s fate would have been different if eviCore had not deceptively designed its website. But eviCore should bear the burden of that uncertainty,” the brief says. “Allowing eviCore to escape liability would be illogical and immoral.”

Fixing prior authorization is a core element of the AMA Recovery Plan for America’s Physicians. You took care of the nation. It’s time for the nation to take care of you. It’s time to rebuild. And the AMA is ready.

Prior authorization is overused and existing processes present significant administrative and clinical concerns. Find out how the AMA is tackling prior authorization with research, practices resources and reform resources.

The promises and misrepresentation the brief refers to come from the claims eviCore made on its website where, among other things, the company’s CEO in a video told visitors that “the patient comes first” and that eviCore is there “really to assure that the patient gets the best care.”

Other areas of eviCore’s website claimed that the company’s approach is:

• “Not to deny care that is needed but rather to redirect providers and patients to more appropriate testing and treatment options.”
• To apply “up-to-date evidence-based guidelines and advanced technologies to ensure that the right evidence-based care is delivered.”
• To “address the full spectrum of potential care and treatment, from holistic and conservative approaches to more advanced and invasive procedures.”

The website further said that the “strong evidence supporting our criteria allows us to make appropriate decisions on patients’ behalf.”

Valentini had every reason to believe the review company would employ sound medical judgment as to what medical tests she should undergo, says the AMA Litigation Center’s brief in the case, Valentini et al. v. Group Health Inc. et al.

But eviCore “did exactly the opposite of what it promised on its website” and delayed an MRI Valentini’s physician ordered, according to the brief, which urges the court to find that the company and other defendants had a legal duty to—in fact—put patients’ needs first, just as it promised on their website. That’s in addition to the duty of care the company owed Valentini because of “the seriousness of her medical condition and the evident need for prompt treatment,” the brief says.

Valentini’s case is an extreme example of how prior authorization harms patients. But the practice commonly harms patient care, physicians tell the court, citing an AMA survey of physicians (PDF) that found prior authorization often negatively affects patients and the practice of medicine. For example, in that survey, 34% of physicians reported that prior authorization has led to a “serious adverse event” for a patient, such as hospitalization, disability or even death.

In late May, the AMA released additional physician survey results (PDF) showing that despite mounting evidence that insurer-imposed authorizations for drugs and medical services can be a hazardous and burdensome administrative obstacle to patient-centered care, the health insurer industry continues to show apathetic or ineffectual follow-through on mutually accepted reforms.

“Although this practice may save money for insurance companies, it is deleterious to patient health and causes substantial inconvenience and frustration to patients and to health care providers, including physicians,” says the physicians’ brief in the Valentini case. “As evident from this case, the prior authorization requirement can endanger health and even lead to loss of life. This case presents an especially egregious case of prior-authorization abuse. Amici seek to ensure that such abuses are minimized and that, when they occur, insurance companies are properly held responsible.”

Find out more about the cases in which the AMA Litigation Center is providing assistance and learn about the Litigation Center’s case-selection criteria.

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PROP Keeps Lying About Opioids – This Time They Got Caught

https://www.acsh.org/news/2022/07/05/prop-keeps-lying-about-opioids-time-they-got-caught-16409

Photo Credit: Piotr Siedlecki , Public Domain Pictures

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New 3-digit phone number offers a lifeline for mental health crisis resources

https://www.verizon.com/about/news/fcc-new-number-mental-health

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Drug distributors win landmark opioid case brought by West Virginia local governments

https://mountainstatespotlight.org/2022/07/04/drug-distributors-win-west-virginia-landmark-opioid-case/

The three largest drug distributors in the United States cannot be held liable for the opioid crisis that has racked Huntington and Cabell County, a federal judge has ruled.

Nearly a year after the landmark trial in Charleston ended, U.S. District Judge David Faber sided with the companies: AmerisourceBergen, Cardinal Health and McKesson. 

“The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington,” the judge wrote in his ruling. “And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law.”

The city and county had argued that the companies created a “public nuisance” because of the sheer numbers of opioid painkillers they shipped to the area over several years.

Lawyers for the drug distributors argued that West Virginia’s public nuisance law was meant to provide communities relief from situations like polluted air or water from a single factory or business. 

Faber agreed with the companies that the city and county shouldn’t be allowed to use the state’s public nuisance law that way.

The judge noted that none of the West Virginia cases involving the state’s public nuisance law was focused on the sale or distribution of a product, such as opioid painkillers. “The extension of the law of nuisance to cover the marketing and sale of opioids is inconsistent with the history and traditional notions of nuisance,” he wrote in the ruling.

He wrote that two lower court rulings, in Marshall and Boone counties, that did allow public nuisance law to be applied to opioid distribution were “not persuasive” and were inconsistent with how the state Supreme Court has interpreted the law.

“To apply the law of public nuisance to the sale, marketing and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product,” the judge wrote.

West Virginia opioid trial: Here are the closing arguments

 

As opioid epidemic raged, drug company executives made fun of West Virginians

The drug distributors also argued that they shouldn’t be held liable for the effects of the opioid epidemic, because all the companies did was supply prescription drugs to licensed pharmacies, as a result of doctors writing prescriptions.

“The volume of prescription opioids in Cabell/Huntington was determined by the good faith prescribing decisions of doctors in accordance with established medical standards,” Faber wrote. “Defendants shipped prescription opioid pills to licensed pharmacies so patients could access the medication they were prescribed.”

Lawyers for Cabell County and Huntington said that the companies shipped 81 million pills to a county with fewer than 100,000 residents over eight years. More than 700 people died of opioid overdoses in Cabell County between 2015 and 2020, according to the state Office of Drug Control Policy.

In their lawsuit, the city and county had asked for $2 billion from the drug distributors for a plan to, among other things, provide more behavioral health services and address the abuse of controlled substances through multiple generations.

On a state level, West Virginia had previously settled its lawsuit with the same three big drug distributors for a total of $73 million. But West Virginia counties, cities and other municipalities weren’t bound by that settlement.

They could have joined the national settlement with the drug distributors, and drug manufacturer Johnson & Johnson, that was proposed last year and finalized this February for $26 billion.

But Huntington and Cabell County officials, as well as dozens more across West Virginia, chose not to be part of the settlement and to pursue lawsuits against the drug companies.

Another trial, with dozens of West Virginia cities, towns and counties suing the same three big drug distributors, is scheduled to begin Tuesday in Charleston. Although this trial is in state court and being handled by Mercer Circuit Judge Derek Swope, many of the other participants, including the lawyers, are the same.

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Looks like some Medical Societies are starting to growing a “back-bone” and finding a “pair”…hopefully there will be more.

ACR Statement on Recent Events: The Patient-Doctor Relationship Must Be Preserved

The American College of Radiology^® (ACR^®) supports the privacy and integrity of the physician-patient relationship. Physicians have a responsibility to recommend appropriate care for all clinical circumstances based on the best available evidence and careful consultation with their patients. The relationship between physicians and their patients is sacred; it must not be jeopardized by non-medical outside interference, including federal, state and local government intrusions beyond public health measures. Instead, physicians, legislators, regulators and patients must work together to ensure access to safe, effective and equitable healthcare for all patients.

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https://youtu.be/zKEhmZe_w9o?t=180

I clipped this video to start at abt 3 minutes in the video… to what is the “meat of the matter’

This is a interesting quote from a “my body my choice” side of the political spectrum… I wonder what this person and others in our population with the same opinion, would say if/when they were asked about those same lawyers, bureaucrats & judges getting between a chronic pain pt and their doctor about if/how their pain is – or is not – treated ?

After all it is claimed that Congress is typically 40% attorneys and back in 1969-1970 that passed the Controlled substance act and it was signed into law by an attorney and the enforcement of this law was handed to the DOJ.  Back then – and some people still believe today – that addiction is a choice and there is no mental health issues involved. The only “tool” that the DOJ had to enforce this law, was jail or prison.

The CSA was passed about 4-5 yrs after the Civil Rights Law was passed and addressed discrimination against those with disabilities. I have seen videos of the Governors of NY & CALF, in particular, claiming that they are going to do whatever possible to not let any law get between a pt and their doctor.. in regards to abortions, but I have not heard these same Governors saying anything about chronic pain pts receiving appropriate care in regards to their pain management.

Unless things have changed in NY, that state several years ago imposed a “Rx opiate tax” on prescriptions. It would appear that the puritanical thread in our societal fabric causes bureaucrats to tax something if they can’t ban or abolish a particular product or activity… just look at tobacco, alcohol, gambling.  Over the last couple of decades, it would seem that the bureaucrats and certain GREEDY LAW FIRMS.. have decided that taxing is just not enough…now they are suing a industry for the perceived “damages” that the selling of a otherwise legal product has caused to individuals in our society , and our society as a whole.  I may be wrong, I have not seen any of the money collected from these law suits being shared with those individuals within our society that have theoretically harmed.  The Tobacco settlement in the late 90’s, where the final agreement… the bureaucracies were to put the money they shared into anti-smoking campaigns, nut many states just threw the $$ that they collected into their GENERAL FUND.

When the CDC 2016 opiate dosing guidelines were published, I did not see any state’s Attorney General going to court, to get those guideline declared unconstitutional. So the denial of care and discriminating against chronic pain pts.. is a bipartisan issue ? 

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