Legal Causation

Posted on July 8, 2020 by Pharmaciststeve

Storyline  – TV show BULL  Season 4 Episode 1

As Bull prepares for fatherhood, his work at TAC suffers without his top attorney, Benny, who quit in reaction to Bull’s romantic reconnection to his ex-wife and Benny’s sister, Isabella (Yara Martinez). In addition, the team faces a difficult time in court as they mount a defense for a young bartender on trial for involuntary manslaughter.

https://legal-dictionary.thefreedictionary.com/causation

High blood pressure dangers: Hypertension’s effects on your body

Harmful effects of UNTREATED PAIN

The basic story line of this episode is that on new year’s eve a bartender sold a patron too much alcohol, left the bar, drove to his ex-wife’s house and killed his ex-wife and 3 friends at the house and he either committed suicide or was kill by the police.  In the interim the bar closed/went out of  business and the relatives of those that died was suing the bartender for serving the person too much alcohol before he killed everyone.

The Bull legal team defended the bartender with the concept that there was no causation between being served “too much alcohol” and him killing four people… of course Bull’s law firm WON…

As I heard the legal term “causation” … my mind started connecting the dots… as causation would apply to the chronic pain community.

I have listed above the link to the bad health consequences to a pt with elevated blood pressure and a table that lists all the complications to comorbidity issues for under/untreated pain.

I can’t count the number of times that pts have told me that when their pain meds were cut/eliminated… their blood pressure goes up dramatically and into unsafe levels.

If a pt’s blood pressure had been at normal/safe levels and starts going up when their meds are cut back/discontinued… and the prescriber doesn’t attempt to treat the pain nor unable to get it back to acceptable/safe levels… You can refer to the above link as to the potential consequences to the pt for under/untreated elevated blood pressure.

It is typically considered “bad medicine” to add medications to a pt’s therapy to deal with side effects of their other medications…  IMO, putting a pt on up to 5 different anti-hypertensive medications to treat their high blood pressure because their pain medication has been reduced/eliminated… should also be considered “bad medicine”

The medical records that a prescriber keeps on a pt should document this cause/effect of the pt’s pain management meds being lowered/discontinued.  Likewise, those same records should document what the prescriber did – if anything – to try to lower the pt’s blood pressure.

Once again, if the prescriber’s prescribing policies and procedures are being dictated by the prescriber’s employer… then the causation could be directed at the “deep pockets” of that employer.

Could those same records be used as documentation when “going after” those people who served on the CDC opiate dosing guidelines and created those same guidelines knew or should have known that they were going to cause pt harm and a path to legal actions against those individuals and/or legal case to get those guidelines revoked ?

 

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Does this explain why medical errors are the third highest reason of deaths?

Posted on July 8, 2020 by Pharmaciststeve

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Pharmacies Wanted for Lawsuit Against Optumrx

Posted on July 7, 2020 by Pharmaciststeve

Pharmacies Wanted for Lawsuit Against Optumrx

Over 500 independent pharmacies have already sued OptumRx for violating the law by:

  • setting MAC prices below a pharmacy’s acquisition cost;
  • paying higher MAC prices to large chains and mail order than to independent pharmacies;
  • collecting brand prices from health plans while paying generic MAC prices to independent pharmacies. 

The firm bringing this case—Jacobs Law Group– is willing to represent pharmacies in new lawsuits against OptumRx on a fully contingent basis. This means pharmacies would not have to advance any money to participate in the case.

Make a call and find out what you can do to fight back against PBM abuse.

Please contact:

Mark Cuker or Conor McCabe at Jacobs Law Group

mcuker@jacobslawpc.com

cmcabe@jacobslawpc.com

(215)-531-8512(office)

215-266-5717 (cell)

www. https://www.jacobslawpc.com/practice-areas/independent-pharmacy-legal-actions

MARK R. CUKER

Cuker Law Firm

mark@cukerlaw.com

215.531.8512 – Direct Dial

215.531.8522 – Main Dial

www.cukerlaw.com

Please note new address

130 N. 18TH ST

One Logan Square, Suite 1200

Philadelphia, PA 19103

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attorneys who have expressed an interest in possibly taking legal action against pharmacies

Posted on July 7, 2020 by Pharmaciststeve

I have spoken with attorneys who have expressed an interest in possibly taking legal action against pharmacies that are refusing to fill, as written, legitimate prescriptions for opiate medication for patients suffering from chronic pain lasting 3 or more months, or suffering from pain associated with a cancer diagnosis, sickle cell disease, or palliative or nursing home care, or which are adding additional requirements in order to get those prescriptions filled. 

 

If you are interested or just want to share your story with them, you can contact them at www.justice4painpatients.com.  

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Independent Pharmacies Sue Major Pbm Over Illegal Price Discrimination And Below Cost Reimbursements

Posted on July 6, 2020 by Pharmaciststeve

Independent Pharmacies Sue Major Pbm Over Illegal Price Discrimination And Below Cost Reimbursements

https://www.cukerlaw.com/independent-pharmacies-sue-major-pbm-over-illegal-price-discrimination-and-below-cost-reimbursements/

Pharmacies Allege OptumRx Knowingly Paid Them Less Than Large Retail Chain Pharmacies

PHILADELPHIA, PA (May 1, 2020) – — The newest litigation against a major pharmacy benefit manager comes from a most likely source: their small business victims. Unwilling to tolerate the low reimbursements which threaten to drive them out of business, more than 50 independent pharmacies have  sued pharmacy benefit manager (PBM) OptumRx, a division of UnitedHealth Group,  charging  the company  violated state laws governing pharmacy claims reimbursement.

The lawsuit alleges that OptumRx ignored state legal requirements, unlawfully paid local pharmacies substantially less than it paid large chain retail pharmacies like CVS or Walgreens and far below what the company paid its own mail order pharmacy for the same prescriptions. The lawsuit further alleges that in many cases OptumRx knowingly reimbursed local pharmacies below their wholesale cost to acquire generic prescription drugs necessary for their patients.

PBMs administer the prescription drug portion of health insurance and self-insured plans, acting as a middleman between the insurance plan and the pharmacist. Over the last 20 years these companies have accumulated immense, unregulated power – the three largest PBMs controlling up to 80% of the healthcare market – and have utilized that power to increase prescription drug costs, decrease competition and restrict patient choice.

The PBM practice of below cost reimbursements to  independent pharmacies is likely one reason why OptumRx is the most profitable component of UnitedHealth Group; the world’s largest health insurance company, with over $225 billion in annual revenues.

Plaintiffs involved in the lawsuit allege that:

  • PBMs dictate reimbursements without notice or negotiation, and the dictated rates are often grossly unrelated to the pharmacies’ actual wholesale costs to acquire the drugs for their patients.
  • Optum charges health care plans brand prices while paying pharmacies the lower generic price for each prescription.  Thus, the pharmacies allege the company is arbitraging prescriptions merely by changing their classification.
  • Optum built a wall of secrecy around its conduct by forcing network pharmacies into confidentiality agreements that conceal the truth about Optum’s business practices – specifically how much Optum is paid by insurance plans for prescriptions, how much Optum receives in rebates from drug manufacturers, and how little Optum pays to pharmacies who actually deal with patients and dispense the drugs.

The survival of independent pharmacies in America’s healthcare system is seriously threatened by the unethical, predatory business practices of PBMs. The lawsuit brought forth by this group of small-business pharmacies seeks to break this wall of secrecy and hold Optum accountable.

The pharmacies are represented by Mark Cuker and Neal Jacobs of the Jacobs Law Group, which represents over 400 pharmacies in lawsuits pending in Federal Court in Pennsylvania. For more information about the lawsuit, contact Mark Cuker at (215) 531-8512.

 

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Needle jockey: Doctor refused to up my dad’s pain meds even tho he told them he was suffering

Posted on July 6, 2020 by Pharmaciststeve

RIP Gravestone

My dad was a chronically I’ll patient. He was 75 and underwent multiple back surgery’s and nerve decompression along w recently broken hip and spine. He fought like hell to live but his family doctor told him due to the FDA guidelines his pain meds had to be controlled by a pain doctor. After months of waiting to get into a pain doctor he was able to get his medicine but the following visit his doctor cut him down to a 1/4 of his dosage, he was not cut down slowly. My dad suffered, he went back to see doctor the following week and doctor was only interested in giving pain shots which don’t work for my dad due to scar tissue. Doctor refused to up my dad’s pain meds even tho he told them he was suffering. Here rothwelldouglas is another interesting article  for you people.


5 days after that visit my dad committed suicide.

I blame the doctor as well as whoever decided to play God and not allow proper dosages of pain meds to chronically sick people.

ANONYMOUS
** They need to hear from people WITH intractable pain and WHO are not getting the medicine they need.
We are are own best spokes person. Write your governor and legislators Personally as others have done.
Also, the articles you see in the magazines at doctors offices are full of misinformation and lies. Few people like you and me know what real protracted pain is and can do to a person or the family of the one suffering.

 

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Temple U must be so proud of this pharmacy student ?

Posted on July 5, 2020 by Pharmaciststeve

 

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Citing declining reimbursements, longtime Indiana, Pa., pharmacy closes

Posted on July 5, 2020 by Pharmaciststeve

Sign outside a closed pharmacy on Route 422 in Indiana County blames pharmacy business managers for running it out of business.Citing declining reimbursements, longtime Indiana, Pa., pharmacy closes

Independent pharmacists and PBMs clash over the impact on the industry

On the day before her Indiana, Pa., pharmacy closed its doors for good, Stephanie Smith Cooney filled a customer’s prescription for life-saving insulin — and lost $30 on the transaction.

It had become an all-too-familiar pattern, she said Monday as she and her staff of 11 at Gatti Pharmacy filled prescriptions and said goodbye to longtime patients one last time. In the past year, she said, fully 80% of the prescriptions they filled had generated a reimbursement payment less than the pharmacy’s cost of dispensing them.

This spring, Ms. Smith Cooney — who took over the pharmacy 10 years ago from William Gatti, son of founder Louis, and Ms. Smith Cooney’s father, David Smith — came to a crushing conclusion:

“We can’t afford to stay in business anymore.”

Like most pharmacists, Ms. Smith Cooney contracts with pharmacy benefit managers, or PBMs, who act as a middleman between a consumer’s insurance company and the pharmacy. Both UPMC Health Plan and Highmark, for example, use the Express Scripts PBM to administer their drug plans.

In January, Auditor General Eugene DePasquale echoed his earlier calls for greater transparency in how PBMs operate, asking the Pennsylvania Senate to pass legislation that would help rein in costs associated with the managers. Mr. DePasquale had previously reported that Pennsylvania taxpayers paid $2.86 billion to pharmacy benefit managers for Medicaid enrollees in 2017, a 100% increase in four years.

“Because PBMs operate as subcontractors,” his office said in a release, “they can shield important information, such as how they select which drugs are covered and whether community pharmacists are reimbursed the same amount as their affiliated chain pharmacies for the same drugs.”

For independent pharmacies like Gatti, a PBM can wield tremendous power in negotiating contracts, dictating reimbursement rates and prices the pharmacy can charge for medications.

But refusing to contract with a pharmacy benefit manager is not a practical option, as that typically means losing access to many, if not most, of their customers.

Without those contracts, “I would be selling used cars somewhere,” said pharmacist Dave Cipple, who owns seven independent pharmacies in Clarion and Armstrong counties.

Until last December, Mr. Cipple owned an eighth pharmacy in Shelocta, Indiana County, which he closed after seeing a sharp decline in reimbursement payments.

“We don’t have the clout to negotiate any reimbursements that are favorable with these folks, so that’s what happens,” he said.

He did get the final word, though: Today, a giant sign outside his vacated storefront on Route 422 shouts, “PBMs WRECKED THIS PHARMACY!”

Greg Lopes, spokesman for the PBM trade group Pharmaceutical Care Management Association in Washington, D.C., disagrees that pharmacy benefit managers are forcing independent pharmacies to close.

“Now more than ever, pharmacy benefit managers are the advocates for Pennsylvania’s consumers and health plan sponsors in the fight to keep prescription drugs accessible and affordable, and are not responsible for independent pharmacy closures,” he said.

“The fact is that there has been an increase in the number of independently owned pharmacies in Pennsylvania over the last 10 years.”

Mr. Lopes cited a March 2020 report done by two Penn State political science professors that said from 2010 to 2019, Pennsylvania saw a 14% increase in the number of independent pharmacies, to a total of 1,058 pharmacies statewide.

Not only are there more independent pharmacies nationally, the report concluded, but also as a group, their prescription profit margins had “increased slightly” between 2017 and 2018.

Patricia Epple, CEO of the Pennsylvania Pharmacists Association in Harrisburg, isn’t buying it.

“We have seen closure after closure.”

She noted the March report used data from the National Council for Prescription Drug Programs, an Arizona-based nonprofit that develops standards for pharmacy services.

The council routinely attributes a greater number of pharmacies in the state than are listed with the state board, she said. “So I am not sure if NCPDP is not removing old ones or exactly what, but something seems to be off.”

An annual digest put out by the National Community Pharmacists Association last year said Pennsylvania had 963 independent pharmacies in 2018, 95 fewer than the Penn State report had.

Ms. Smith Cooney believes she knows what’s behind the discrepancy, at least in part.

“In my experience just today, I was instructed to leave my NCPDP status active even though my status with the state board and DEA are now inactive,” she said Wednesday. “If my case is similar to others, NCPDP status would be a poor way to measure pharmacy numbers.”

Closing the pharmacy has been much more than a numbers issue for Ms. Smith Cooney.

As a young girl, she would do odd tasks at the store where her father was a pharmacist. She did her training there as a pharmacy student, then became a partner after earning her pharmacy degree and bought the business — which was founded in 1936 — in 2010.

The pharmacy offered services such as Gatti’s AutoSync RX program that allowed patients to get all of their prescriptions at one time with a phone reminder when it was time to pick them up. It also tracked late and missed refills.

“They deliver a personal service that you don’t always see in this day and age,” said Linda Mitchell, executive director of the nonprofit Downtown Indiana Inc., which works to keep the corridor of shops and restaurants vital and appealing.

Ms. Smith Cooney said they’d kept costs under control, and annual revenue had grown 10% the past year. “For all intents and purposes, we should be thriving.” But the increased revenue was not enough to offset the reduced reimbursements and still cover the pharmacy’s staffing and overhead costs.

Instead, the 2,000-square-foot storefront at the west end of Indiana’s core business district has gone dark, with the Gatti store inventory and patient files now transferred to the local Rite Aid.

“It’s definitely the end of an era for Indiana,” said Ms. Mitchell.

Steve Twedt: stwedt@post-gazette.com or 412-263-1963.

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At Walgreens: the bottom line is the ONLY LINE THEY CARE ABOUT ?

Posted on July 5, 2020 by Pharmaciststeve

https://youtu.be/JCn48O9Q48E

I am sure that a lot of pharmacists are glad they are working in a “right to work state” … there are some 25 states with this law on the books..  Businesses can fire you for any reason – or no reason – without consequences.

Pharmacists have not been paid $35 – $40/hr since the late 90’s or early 2000’s. There was a period of time 2000- 2010 when there was a severe shortage of pharmacists.. at its peak they claimed that there was 6,000 empty job slots that there was no pharmacists to fill them.

At about the same time the profession went from a 5 yr degree to a 6 yr degree program so on top of everything else we had almost NO GRADUATES ONE YEAR.

New Pharmacy schools started opening and they were getting 5-6 applicants for every available pharmacy school slot. we went from 80 odd schools till today we have abt 140 schools…. and they are now graduating 3 pharmacists for what maybe 2 available job slots..

During this time, the feds increased the limit on what students could borrow for college and in turn the colleges raised their tuition.. so students were coming out of college with larger and large student loan balances… not unusual for pharmacy grads to have $100,000 + student loan balances…  of course when they started pharmacy school they were expecting to make 100,000 – 120,000/yr when they become licensed.

So now we have pharmacists – that all but the Pharmacy manager are lucky to get 30 hrs/week … so now they have a student loan more than many people have loans on their houses and going to be grossing MAYBE $60,000/yr.

So many of the pts dealing with subjective diseases and trying to get controlled substance Rxs filled and run into many of these newly graduated pharmacists with a whole lot of “book smarts” and little/no real clinical experience.. I would not be surprised for a lot of these pts to get “I’m not comfortable” filling your controlled Rxs..

But there are always independent pharmacists … where the pt will typically be dealing with the Pharmacist/owner and won’t be someone fresh out of school with the ink still wet on their license here is a link to help you find one by zip code.   https://ncpa.org/pharmacy-locator

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A Proposed Lottery System to Allocate Scarce COVID-19 MedicationsPromoting Fairness and Generating Knowledge

Posted on July 4, 2020 by Pharmaciststeve

A Proposed Lottery System to Allocate Scarce COVID-19 MedicationsPromoting Fairness and Generating Knowledge

https://jamanetwork.com/journals/jama/fullarticle/2767751

 

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the unapproved drug remdesivir to treat hospitalized patients with severe coronavirus disease 2019 (COVID-19). The authorization was based on a preliminary report from a randomized clinical trial in 1063 patients that found that remdesivir shortened the median time to recovery from 15 days to 11 days.1 Anticipating immediate worldwide demand, the maker of remdesivir, Gilead Sciences, donated 1.5 million doses of remdesivir to countries affected by the pandemic, including the US, which received 607 000 doses (enough to treat approximately 100 000 patients). However, the US and other countries have 2 major problems related to this drug. First, the supply of remdesivir is insufficient to treat all eligible patients, which has required hospitals to ration the drug.2 Second, there remain major gaps in knowledge about the efficacy of remdesivir, including whether it reduces mortality and what subgroups of patients may benefit the most.

These problems are not specific to remdesivir or to the current pandemic: governments and health systems will predictably encounter situations during pandemics in which novel therapeutics are in short supply and knowledge about their harms and benefits is limited. Promising results from clinical trials of convalescent plasma,3 monoclonal antibodies, or other experimental drugs will put pressure on the FDA to emergently authorize use in the face of incomplete knowledge about efficacy and insufficient supply. Without careful planning, the rollout of such emergency authorizations risks unfair drug allocation and missed opportunities to learn more fully about the effects of these medications.

When there is an insufficient supply of newly approved antiviral agents (including remdesivir), the drug should be allocated to patients using a lottery system overseen by state health departments. In this model, states would create a central registry into which hospitals report the demographics and clinical outcomes of all patients entered into the lottery, including those who are not allocated the drug. This approach could simultaneously accomplish fair allocation (via the lottery) and rapid learning, because the lottery creates a natural experiment4 that achieves random allocation in which some patients receive the drug while others do not; researchers can use the lottery’s registry to assess the effectiveness of the scarce drug.

Critique of the US Response to the Remdesivir Shortage

The initial federal and state allocation of remdesivir has 2 major problems: unfair allocation of the drug to patients and missed opportunities to generate new knowledge that could reduce morbidity and mortality. After a largely unsuccessful attempt by the US Department of Health and Human Services (DHHS) to distribute remdesivir to hospitals across the country, the DHHS delegated this responsibility to state health departments.5 Some states provided no guidance to hospitals about how to select among eligible patients when the supply was insufficient for all patients, whereas others provided guidance that is ethically problematic.

For example, the New Jersey Remdesivir Advisory Committee advised that “remdesivir [should] be used in eligible patients on a first-come, first-served basis.” Similarly, the Minnesota Department of Health created 2 tiers of priority based on the severity of patients’ respiratory failure, then instructed hospitals that “no courses…should be held in reserve for future use. All courses should be immediately allocated.” First-come, first-served approaches disadvantage patients with poor health care access, such as individuals with disabilities who require special travel arrangements to reach the hospital. These approaches also render states unable to accomplish important ethical goals of public health, such as prioritizing patients most likely to benefit, or mitigating the disproportionate effects of COVID-19 on disadvantaged groups and essential workers.

The second major problem with the US government’s response is the absence of a plan to use the government’s supply of remdesivir to gain additional knowledge about its effectiveness. The FDA’s Emergency Use Authorization for remdesivir requires hospitals to report only serious adverse events that are potentially attributable to remdesivir. This minimal reporting requirement misses an opportunity to collect outcome data that would shed light on several pressing questions, such as whether remdesivir has an overall mortality benefit and whether certain clinical subgroups are more likely to benefit than others (eg, patients with mild vs severe hypoxemia).

A Centralized Lottery System

The allocation of scarce COVID-19 drugs should occur via a lottery system overseen by individual state health departments. Oversight by states, rather than the federal government, is appropriate because medical practice is regulated by states and because states have local health officers who could coordinate such activities. As part of participating in the lottery, health systems would report information on all patients entered into the lottery, not just those who ultimately receive the drug.

In practical terms, implementing a central lottery system would be relatively straightforward. States would determine the lottery’s baseline treatment probability for individual patients based on the number of available courses of remdesivir and epidemiological projections of the number of cases expected in the state over the period the supply of drug is supposed to last. When treating clinicians in a hospital identify a patient who is eligible to receive remdesivir, rather than appealing to a hospital-based committee for allocation of the drug, they would instead make the request to the state health department via telephone or an online portal. The clinicians would provide demographic and clinical information about the patient, which would be entered into a registry covering the entire state. A state health officer or designee would verify that a patient meets eligibility requirements for remdesivir, conduct the lottery using a random number generator, and inform the treating clinicians whether the patient can receive remdesivir. If so, the state would authorize the release of the drug to the patient. To achieve rapid distribution, the drug could be held in numerous regional locations across the state. Hospitals would report patients’ clinical outcomes at death or hospital discharge to the registry, which could be made available to researchers for analysis after enough patients are included.

Although the purpose of the lottery is to fairly distribute a scarce public resource, a secondary benefit is that the lottery creates randomization, which balances known and unknown confounders across patients who receive or do not receive remdesivir. In essence, the lottery creates a natural experiment that could be leveraged by researchers to make causal inferences about the effect of a factor outside their control (eg, the medication lottery) on patient outcomes in a situation resembling an actual experiment.4 Research leveraging previous lotteries in society has yielded important scientific insights, such as the Vietnam Draft Lottery and the effect of military service on lifetime income.6

Conducting the lottery at the state level, rather than having many individual hospitals conduct hospital-level lotteries, could allow rapid accrual of a large number of patients, providing greater statistical power to assess the effectiveness of remdesivir among clinical subgroups. If needed, researchers could pool data from multiple states to enhance statistical power.

There is precedent for using the occurrence of drug scarcity to advance scientific knowledge. The first published randomized clinical trial occurred in similar circumstances in the late 1940s. Small nonrandomized studies of streptomycin for pulmonary tuberculosis had yielded encouraging but inconclusive results; manufacturing challenges limited the amount of streptomycin that the British government could procure such that not all patients in need could receive it.7 Therefore, a team led by Bradford Hill used randomization to fairly allocate the scarce streptomycin and to rigorously evaluate its efficacy, which ultimately proved effective in reducing mortality from pulmonary tuberculosis.8

A major advantage of lottery systems is that even though they introduce randomness, they need not provide the same chances to all patients. Instead, to achieve public health goals, states can use a weighted lottery to give increased priority to certain groups, such as those most likely to benefit and those who have been disproportionately harmed by the pandemic. For example, the Commonwealth of Pennsylvania recently endorsed a weighted lottery system developed at the University of Pittsburgh that gives increased chances to receive the scarce treatment to essential workers and individuals from economically disadvantaged areas.9 A strength of a central lottery, compared with hospital-level lotteries, is efficiency. State-level lotteries could significantly decrease the administrative burden for the thousands of hospitals in the US that would otherwise need to develop and administer a scarce drug allocation protocol.

Response to Potential Criticisms

Administering the centralized lottery would require additional effort by state agencies. However, the time and expense to do so is relatively small compared with the magnitude of potential benefit derived from a program that ensures fair allocation and allows greater knowledge about the drug’s effectiveness. The data obtained from the lottery are not immune to the weaknesses of natural experiments, such as lack of blinding, but there are accepted strategies to mitigate the weaknesses, such as relying on outcomes that are unlikely to be influenced by knowledge of treatment (eg, mortality).4 Some may assert that the proposed lottery would require patient-level consent for research. However, the lottery is not a research maneuver; it is a public health intervention to fairly allocate a scarce resource that creates a type of natural experiment.

Conclusions

If state health departments had instituted lotteries with registries to allocate the first shipments of remdesivir in May 2020, substantially more information about the effectiveness of remdesivir would likely be available now. Implementing central lotteries paired with registries of clinical outcomes could simultaneously allow fair allocation of scarce COVID-19 medications and facilitate knowledge generation that could reduce morbidity and mortality during the pandemic.

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