CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 3

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 3

https://pharmacistactivist.com/2020/March15_2020.shtml

I have come to recognize that the CVS situation is even worse than I thought. CVS pharmacists and technicians respond to my editorials with their own experiences that are so outrageous that none of us could make them up. I am very sympathetic regarding the circumstances these individuals must contend with, but I highly commend them for their willingness to voice their concerns, and I appreciate their trust that I will protect their identity.
CVS creates risk for consumers
Vaccines to protect against influenza are available in “regular”-dose formulations, as well as high-dose formulations that are recommended for individuals such as the elderly who are at greatest risk of serious complications from the flu. Earlier in the current flu season, the high-dose vaccine was in short supply and many pharmacies were out of it.

I have learned that, during that time, some CVS pharmacists were “encouraged” to use regular-dose vaccines for all patients even though they recognized that some of the patients were candidates for the high-dose vaccine. Rather than “losing” the patient to a physician or another pharmacy which had the high-dose vaccine, or jeopardizing not meeting management-imposed immunization quotas, CVS placed some of the most vulnerable patients at greater risk by not using the vaccine with the most protective dosage. It is my understanding that this “encouragement” came from local management (e.g., district leaders), as corporate management would certainly have recognized the risk to CVS if such a request would be discovered to have come from corporate.
CVS causes harm
The situation that I describe below is just one of those for which I personally know the pertinent, specific information.

A 5-year old girl underwent surgery and Roxicet (oxycodone-acetaminophen) 5-325 mg/5 mL was prescribed for management of her pain. The typed directions on the prescription were: 2.5 mL every 4 to 6 hours as needed. The pharmacy technician and pharmacist, in entering and verifying the information, respectively, made errors with the result that the label on the prescription container contained the directions: 2.5 teaspoonfuls every 4 to 6 hours as needed. Following the administration of several 5-fold overdoses, the child lost consciousness. Following hospitalization, the error was recognized, naloxone was administered, and the child survived.

CVS acknowledged that an error had been made. However, it initially claimed that it was not financially liable (beyond the costs of hospitalization) because the child had not been permanently “harmed,” because the overdosage was successfully reversed and the child was presumably healthy again. CVS settled the case with the family. Although the error was made by the pharmacist and technician, management-imposed metrics and the resultant staffing and working conditions were important factors, with the pharmacist acknowledging dispensing about 500 prescriptions in a 10-hour shift.
CVS kills
A middle-age woman died as a consequence of complications from using oxycodone and other opioid-containing formulations that were initially prescribed for pain management prior to and following back surgery. Oxycodone was prescribed over an extended period of time, with the dosage often being increased, presumably because of the extent to which the patient experienced tolerance and dependence. The vast majority of prescriptions were written by the same physician and dispensed in the same CVS pharmacy by the same pharmacist. Following the death of the patient when I was made aware of the situation, the number and potency of oxycodone tablets being provided to the woman were so high that I raised the question as to whether she was actually taking that many tablets herself or whether there was diversion. I was informed that the possibility of diversion had been thoroughly investigated and ruled out, and that she was personally using all of the tablets provided her.

The prescribing physician and dispensing pharmacist were at fault in enabling these circumstances and the tragic outcome. However, it was also clear that CVS management did not have controls, safeguards, or supervision that would have identified and intervened in a situation in which there was such clear evidence of opioid misuse.
CVS lies
Consider the following recent statements of CVS corporate:

“Patient safety is our highest priority.”

“Qualified and trained pharmacy technicians allow pharmacists to have more time to provide patient care, answer questions about medications and serve as true health care counselors…”

“Metrics are meant to provide better patient care, not penalize pharmacists.”

“We have a firm non-retaliation policy in place for any employee, including our pharmacists, who want to voice a concern.”

These statements have absolutely no credibility among most of those who are in the best position to respond – the CVS pharmacists and other employees. By making such statements that can be so quickly and comprehensively challenged with examples, CVS self-inflicts much of the damage to its own credibility.

CVS steals
Primarily through its Caremark PBM and Aetna health insurance, CVS steals patients from other chain pharmacies and independent pharmacies. Many of the affected patients have enjoyed and benefited from the services and friendship of their previous pharmacists for decades.

Through its metrics and “expectations” that its pharmacists complete the prescriptions and other responsibilities occurring on their employment shift, CVS steals from its own pharmacists by not paying them for time worked “off-the-clock.” One CVS pharmacist who maintains very careful records told me that he worked the equivalent of more than 4 weeks “off-the-clock” in 2019. In another situation, a district leader informed the pharmacists in his district that his expectations are that each pharmacist must stay 1 to 2 hours past the end of their shift to finish filling prescriptions, and that it is part of their duty to do so. This “expectation” of the district leader is an acknowledgement that it is not possible to complete all the prescriptions during regular hours with the number of pharmacist and technician hours of staffing provided. CVS pharmacists should specifically document such comments as soon as possible after they are made. They should also maintain detailed records of how many hours they work “off-the-clock.”
CVS cheats
CVS cheats pharmacies other than those it owns by not providing fair compensation for prescriptions and services for patients covered by Caremark and other CVS-owned prescription plans.

On December 17, 2019, the U.S. Department of Justice sued CVS and its Omnicare unit for violating the federal False Claims Act by illegally dispensing drugs to tens of thousands of patients in assisted living facilities, group homes for people with special needs, and other long-term care facilities. The complaint alleges that Omnicare assigned new numbers to prescriptions after the original prescriptions expired or ran out of refills, under what the company internally called “rollover” prescriptions. CVS responded that it did not believe the claims had merit, that it intended to defend itself in court, and “We are confident that Omnicare’s dispensing practices will be found to be consistent with state requirements and industry-accepted practices.”

The January 13, 2020 edition of Bloomberg Businessweek includes an article, “The Big Drug That Couldn’t,” (Riley Griffin with James Paton; pages 12-14) that provides details of how CVS Caremark, Express Scripts, and others manipulate the costs and availability of drugs to the disadvantage of patients, healthcare professionals, government agencies, and society. Amgen’s cholesterol-lowering drug Repatha was approved and marketed in 2015 at an annual cost of $14,100. Half of all patients prescribed Repatha, or a similar drug Praluent, were denied approval for coverage during the first year these drugs were on the market, and many patients who were approved by their prescription plans often couldn’t afford their share of the cost. In late 2018, Amgen cut its list price by 60%, to $5,850 annually. However, the substantial reduction in list price failed to boost sales. The story continues as follows:

“Throughout 2019, many drug middlemen ignored the lower-priced meds in favor of putting the $14,000 versions on their approved lists-which would give heftier rebates.

CVS Health Corp., for example, asked prescribers to provide one of two codes to request access to either the $14,100 product or the $5,850 product. Although it stated ‘the two products are the exact same and made in the same manufacturing facility,’ the company required a ‘documented clinical reason’ to access the cheaper drug. Even with such a reason, CVS said it wouldn’t make the discounted drug available. So doctors filling out forms essentially had only one choice: request the expensive option.”

The chief medical officer of CVS Health “says the $14,100 product initially offered health plans the lowest net cost because the company could pass them the rebate. However, he concedes its demand for a ‘clinical justification’ for the discounted product was inaccurate and unnecessary. ‘It was a business decision that should have been reviewed more deliberately,’ he says. After five months, CVS updated the form to eliminate that question and now covers the $5,850 version of Repatha.”
CVS retaliates
A pharmacist employed by CVS for more than 25 years was so concerned about the inadequate staffing, working conditions, and risk of errors that she convened a small group of CVS pharmacists to meet with their district leader to voice their concerns. The response was that increasing technician hours was out of the question and that they had a responsibility to meet the required metrics. Several months later she was terminated with the reason identified as violation of company policy because she rang up a personal sale for one of her own medications (which she did because of a lack of help and trying not to distract the technician from more important work).

A pharmacist employed by CVS for more than 30 years and who was about a month away from retirement, was terminated the day she returned to work following knee surgery. The explanation for her termination was that she was not filling prescriptions fast enough.

These two terminations are not isolated experiences, and the prevailing rumor is that the underlying reason for termination is age discrimination. Older pharmacists who have been employed by CVS for many years are making higher salaries than CVS would have to pay new pharmacy graduates who have huge college debts and may be desperate to identify any pharmacist position, even if the salary is much lower than previous norms. One individual has characterized pharmacists as quickly replaceable links in the CVS chain gang of pharmacists.

The concerns about situations such as those described above is now extending beyond our profession of pharmacy. If you were a CVS pharmacist and were terminated during the last 3 years for what you consider to be arbitrary, capricious, unjust, and/or retaliatory reasons (including violations of minor policies for which a warning [rather than termination] might typically be anticipated), I encourage you to contact me at danandsue3@verizon.net with a summary of the circumstances. I will not disclose your identity, and your provision of such information will be helpful in determining possible reasons/patterns for terminations, and the potential for pursuing further actions. Many current and former CVS pharmacists do not currently receive this newsletter, so please encourage them to sign up to receive it free-of-charge at The Pharmacist Activist.

The CVS acquisition of Aetna initially required the planning and agreement of the CEO of CVS and the CEO of Aetna, and subsequently the approval of the Boards and shareholders of the two companies. The CEO of CVS was designated as the CEO of the combined corporations, and the former CEO of Aetna was appointed to the Board of Directors. As his first term on the Board was concluding, the former CEO of Aetna learned, contrary to his understanding and expectation, that he was not being considered as a candidate for re-election as CVS was “downsizing” its Board to be better aligned with “best governance practices.” One can imagine the former CEO of Aetna thinking, “with friends like CVS, who needs enemies?” But don’t shed any tears for him. He was extremely well compensated for selling out Aetna, its employees, and the patients covered by its health plans.
CVS places its employees at risk
CVS and some other chain pharmacies have installed time-delay safes in some stores to discourage robberies, and signs are placed in the pharmacy regarding the safes. When a pharmacist needs to open the safe, he initially activates it but the safe remains locked for several minutes. It is my understanding that there is a signal after several minutes when the door of the safe can be opened but, if the signal is missed (as could often occur in a busy pharmacy in which the pharmacist is multi-tasking), the lock is reset for the same number of minutes. This can significantly slow down a pharmacist in an understaffed pharmacy trying to comply with management-imposed metrics and policies. However, that is not the most important concern. I would contend that the use of such safes places pharmacists and other employees at greater risk of being harmed.

A would-be armed robber may already be high on drugs, possibly can’t read or has not taken the time to read the posted signs, and is unlikely to be thinking clearly. If the pharmacist responds to the robber’s request for drugs by saying that the safe can’t be opened right away, I wouldn’t expect that the robber would turn around and run out of the pharmacy, or instruct the employees to lie on the floor while they all wait for the safe to unlock. Rather, I would anticipate that the robber would be angry and irrational, and threaten or harm the employees. I learned from a CVS pharmacist that he was directed to have a bottle of 100 generic Vicodin on top of the time-delay safe that could be provided to a robber if circumstances became threatening. Another pharmacist states that CVS is more concerned in protecting the drugs and its money than in protecting their employees.

In a busy pharmacy in which the time-delay safe must be opened often to prepare prescriptions, I would anticipate that the pressures created by understaffing and metrics will result in pharmacists not locking the safe every time it is opened. I only hope that CVS management would not use such a situation as an excuse to terminate or otherwise discipline a pharmacist for not complying with a policy, assuming one exists. Pharmacists must have the authority to make the workplace decisions that will best protect the safety of the customers and employees, and not be required to rigidly follow policies that have been created by management/executives who are not exposed to such risks themselves.
CVS is unethical/fraudulent
I discussed earlier situations in which the shortage of high-dose flu vaccines resulted in some patients being administered the regular-dose vaccine, even though their risk factors warranted the higher dose. I have learned of situations in which local CVS management has asked its pharmacists to contact these individuals and encourage them to now come in to receive the high-dose vaccine. This may actually be excellent advice for patients at high risk of flu complications. However, this is not the motivation for this action, but rather it is to meet or exceed immunization quotas. But who should pay for the second immunization that has been prompted by CVS initially administering the less appropriate dose? Certainly not CVS! This has been thought through with the possibilities including that insurers may not catch/deny a second immunization during the same flu season, that administration of one immunization in the fall and the second in the spring will be in different plan years and not be flagged, or that some individuals will have changed insurance coverage from one calendar year to the next.
CVS is destroying other pharmacies and the profession of pharmacy
Many independent pharmacies have closed and many more are on the brink of doing so because they can’t financially survive the anticompetitive policies and actions of CVS and other PBMs/health insurance companies. The impact on an independent pharmacy can be even better understood in the context of Target, the very large and successful national retailer, not being able to operate its pharmacies profitably, with the result that it sold them to CVS.

Several days ago it was announced that Ephrata, PA-based Royer Pharmacy will close its 5 pharmacies by March 18. Continuously operated for 141 years, it has more than 90 employees, some of whom may be offered positions at CVS, to which the prescription files have been transferred. P. J. Ortmann, one of Royer’s pharmacists captures the experience with the following comments:

“A very sad week in the pharmacy. Shock, disappointment, disbelief, and even some tears and hugs from patients. Many, many calls from physicians and office staff offering support for the Royer staff and sincere appreciation for all of the personal service offered at Royer Pharmacies which is not seen at the chain pharmacies. Providers are very concerned for their elderly and special needs patients who will now not have a local business who will make exceptions, pay special attention to prescription treatment, and accommodate inability to pay for prescriptions. They expressed how local independent pharmacy care for patients made their job as care providers easier, and more successful.

Congratulations to our “concerned” legislators – hope you enjoy your lobbyist donations which influence your decisions and lack of action to care for your constituents the way we care for those same patients. Sleep well tonight!”

Pharmacists practicing in hospital and long-term care facilities must not consider themselves immune from these experiences. The destruction of independent pharmacies is only the beginning of the destruction of our entire profession if we don’t take strong actions. Some hospital administrators and owners of long-term care facilities have observed what chain pharmacies, PBMs, and health insurance companies have been permitted to get away with, and are already starting to take similar actions.
Actions needed
What Pharmacy Needs Most is a Revolution! (Please see my editorial in the January issue). Many more pharmacists are becoming outraged! Many pharmacists are desperate to find employment! However, they are also encouraged by the increased awareness of the public regarding the chaos in chain pharmacies as a result of articles such as those of Ellen Gabler in the New York Times. They are emboldened to share their experiences even if their identity must be protected. CVS is scrambling to construct excuses and protect its management, but there is reason to believe that all is not well at headquarters in Woonsocket.

BUT PHARMACISTS MUST BE ON GUARD! If CVS management can find ways to blame pharmacists for errors, drug-related problems, and policy violations, they will do it, and even terminate some alleged “wrongdoers” in their local pharmacies as evidence that management is taking the criticisms seriously.

The profession of pharmacy must respond by exploring the potential for class-action lawsuits on behalf of pharmacists who have been terminated for arbitrary, capricious, unjust, and/or retaliatory reasons. Current and closed independent pharmacies should explore the potential for class-action lawsuits against PBMs and health insurance companies to recoup the financial losses resulting from their anticompetitive actions and harm.

In a strong and concerted effort, pharmacists must hold their legislators accountable for the situations that have been so damaging for their constituents, pharmacists, and other healthcare professionals, and must insist that governments not use anticompetitive PBMs for administering the prescription plans for government employees.

Daniel A. Hussar
danandsue3@verizon.net

 

Sometimes the bureaucracy sides with the pt when they feel they have been short-changed with their care

Does a practitioner’s ethnicity effect the care they provide to females ?

I made the above blog post back in Nov 2019. Concerning Barb’s experience on a < 24 hr hospital admission and a hospitalist that our hospital requires pts to be seen by and our PCP is no longer allowed to see his pts while they are pts in the hospital. Since our PCP’s practice is now OWNED by the hospital and our PCP is JUST AN EMPLOYEE OF THE HOSPITAL… they can dictate who can provide us care when in the hospital.

We live in a metro area of about 1.5- 2 million people and there are two other major hospital system in the metro area. If we are being forced to see a hospitalist, does it really matter what hospital you go to..  Our local hospital has – according to their website – 20 hospitalists on staff..  Unless we are both unconscious, this hospitalist will not take care of either of us in the future. They are all on the same electronic medical record system (EPIC).. so our PCP will have access to our hospital medical records when we return to see our PCP.

I have omitted the hospitalist’s name because I have complaints filed with two other bureaucratic entities that has oversight of his actions – or in-actions – and this is the first written response that I have received in response to my complaints, and I may not be finished with him yet.

Livanta is the organization that oversees that Medicare pts receive appropriate care from healthcare providers.  If – and only if – pts file complaints when they feel they have received less than adequate care. This letter/action has taken four months to get to this point and it could be just the first step before we reach the end of the path in regards to this issue.

NC Board of Medicine – must have a bunch of “loose screws”

NORTH CAROLINA HEALTH NEWS

https://www.painnewsnetwork.org/stories/2020/3/10/tweet-led-to-dr-kline-losing-his-dea-license

How can anyone from a medical licensing board that would take a complaint from a person that does not even live in the state where the doc is licensed to practice and has never been a pt of the doctor to take a twitter complaint SERIOUSLY ?

But apparently Julie Roy ( @royjulie33 ) posted the above on twitter about three weeks after Dr Thomas Kline posted the above tweet.

Roy pulled a statement from a unidentified Mayo Clinic Staff member as justification for her complaint and apparently the NC Medical Board took it seriously. She even made this statement in the tweet 

HE WOULD LOVE TO PRESCRIBE EVERY PERSON ON EARTH AN OPIOID…

Such of hyperbolic statement from a totally disconnect person to Dr Kline should have been a discredited from the very start by the medical board !

As if a 76 y/o physician could be licensed to practice everywhere in the world !  Dr Kline only had 34 pts taking opiates, not running a “pill mill” !

The NC Medical Board actually has a website with a specific page to file a complaint   https://www.ncmedboard.org/resources-information/file-a-complaint-report … again a person who does not file a complaint via the acceptable path was not just acknowledged but apparently taken seriously.

Unfortunately this woman’s son died of a Heroin overdose, so it would appear that her family’s gene pool has a defective gene that is the cause of mental health issues of an addictive personality and her son fell into that 1% +/- that can/will become addicted to a opiate.  Did her son every actually have a legal prescription for a opiate ?  If not, where did he get his first dose(s) of a opiate or did he just start with an illegal opiate like Heroin ?

At last report, 3 of Dr Kline’s NC34 pts were on a suicide watch…  Woman Roy feel much better if those three chronic pain pts died from committing suicide ?  If so, maybe she could be charged with contributing/assisting people to commit suicide ?

Could CVS pharmacists become “MORE UNCOMFORTABLE” in filling controlled Rxs ?

 

 

 

 

 

 

 

 

 

 

 

 

 

If you notice in this graphic the Management Team member FAILURE TO REPORT IN A TIMELY FASHION A POTENTIAL VIOLATION OF LAW OR COMPANY POLICY RELATED TO CONTROLLED SUBSTANCES  can result in disciplinary action – including termination on FIRST OFFENSE

We have a SERIOUS and GROWING Pharmacist surplus.. it has been reported that for every 3 new pharmacist grads… they will be chasing MAYBE two available job openings..  We are supposedly graduating 15,000 new pharmacist every year… so we have 5000 pharmacists are looking for jobs that DO NOT EXISTS.  It has also been reported that only the pharmacy manager (PIC Pharmacist in Charge) are the only ones getting FULL TIME POSITIONS. The rest are lucky to get a scheduled 32 hr weeks and may be able to pick up a extra shift now and then. What the new pharmacists are getting paid is substantially below what pharmacists were being paid when they started pharmacy school six years earlier and many have SIX FIGURE STUDENT LOANS.

What sort of COMPANY POLICIES has CVS implemented or going to implement in regards to the filling of controlled substances and if Pharmacist could be fired for the POTENTIAL VIOLATION of some obscure company policy or some obscure interpretation of any law or policy.  Is more and more pharmacists going to find the only “safe harbor” is to JUST SAY NO to filling controlled substance Rxs  ?

Here is a article from some time ago  Chains’ ties run deep on pharmacy boards  that indicated that non practicing corporate pharmacists are controlling most of the state pharmacy boards. Who believes that any of these pharmacy boards will respond to denial of care by pharmacists – particularly chain pharmacists ?  When most of those controlling the boards are employees of the same corporations whose employees are the ones that are denying care and are doing so at the direction of the corporation’s policies and procedures.

Yes, the state boards of pharmacy holds the license every pharmacist, pharmacy and wholesaler in the state, BUT.. the DEA holds the license on every pharmacy, wholesaler and prescriber in a state and the DEA is probably best described as the “BIGGEST/MEANEST BULLY IN THE SCHOOL YARD “

 

 

Could handling USA paper currency cause you to fail a urine testing for opiate/illegal substance ?

The DEA Is Worried Sick About Touching Contaminated Drug Money

https://www.thedailybeast.com/the-dea-is-worried-sick-about-touching-contaminated-drug-money

The U.S. Drug Enforcement Administration (DEA) is so concerned that drug-laced cash seized in narcotics busts could seriously injure—even kill—its agents, it has begun reaching out to potential industry partners about decontaminating confiscated currency, The Daily Beast has learned.

“Some of the substances on the currency may be extremely harmful to human health and potentially result in death,” says a DEA solicitation posted late last week on a U.S. government procurement portal.

“It is expected that most of the substances on the contaminated currency will be controlled substances including, but not limited to, narcotics (fentanyl, fentanyl analogues, heroin), cannabinoids (marijuana, THC, JWH compounds), stimulants (amphetamines, cathinones), hallucinogens (LSD, PCP, NBOMes), depressants (benzodiazepines, barbiturates),” the solicitation continues. “Precursor chemicals used to make these substances and other unknown harmful chemicals may also be present on the currency.”

The nascent currency decontamination initiative has not been previously reported, and DEA is looking for a vendor who can service to all of its 222 domestic offices. The agency has put out an RFI, or Request For Information, from vendors with experience in decontamination; the next step would be an RFP, or Request For Proposals. Shenika Butler, the Department of Justice contracting officer overseeing the RFI, declined to comment. A DEA spokesman said he was unfamiliar with the plan.

If the program becomes operational it would be an apparent first in American policing, and the DEA seems to be spooked enough about the idea of toxic money that it “will not count the contaminated currency (due to inherent safety issues) prior to packaging the contaminated currency, but will have a general indication of the amount that has been packaged for the vendor,” last week’s solicitation reads.

However, longtime law enforcement veterans tell The Daily Beast that “poisonous” drug money is not a concept they’ve ever heard of before.

Special Agent Dennis Franks spent 22-plus years with the FBI, which included a stretch at the helm of a multi-agency drug trafficking task force.

It’s standard for agents to wear latex gloves when they handle drug money, but that’s always been about the extent of it, said Franks. And although it has long been common knowledge that a majority of U.S. currency bears trace levels of cocaine residue, the amounts are far too minute to elicit any sort of biological response. (An esoteric industrial process using heated, pressurized CO2 to clean soiled notes has been marketed to central banks in recent years as a way to remove built-up sebum and grime on the surface of bills, thus keep them looking fresher and circulating for longer.)

The idea of decontaminating drug money is also a brand-new notion to former NYPD Detective Sergeant Joseph Giacalone, now a professor at CUNY’s John Jay College of Criminal Justice.

He points to fentanyl as the primary catalyst for any extra safety precautions cops are taking nowadays.

“There’s some pretty scary stuff going on,” said Giacalone. “There was always some inherent risk to police work but in 2018, with these designer drugs, it’s become even worse.”

Fentanyl and its analogue carfentanil are 50-100 times more powerful than morphine. According to the Centers for Disease Control and Prevention, accidental exposure can be potentially life-threatening in certain instances, which include “inhalation, mucous membrane contact, ingestion, and percutaneous exposure (e.g., needlestick).”

Could someone routinely handling US currency – especially paper currency – absorb enough of these illegal substances from our “paper money” ?

Is it time for all chronic pain pts that have to undergo routine urine testing to determine if they are taking their medications and not taking any illegal substances or medications that they are not being prescribed ?

Is it time for all of those chronic pain pts to STOP USING CASH and move all their purchases over to debit/credit cards for as many of their purchases as they can?  You don’t know what is on the paper currency that you are using.. it could be illegal drugs or it could be CORONAVIRUS (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html  

The next time you read where someone gets a positive urine test for something that should not be in their system and no one can explain why ?

 

 

Combating the Opioid Epidemic with the False Claims Act

Could this same law be used against docs that are “forcing” pts to have ESI… Since the primary category of meds used in the ESI are Corticosteroids and both the FDA and the primary pharma that makes this category of med DISCOURAGES this category of med being used in ESI.  There are many countries that PROHIBIT the use of this category of meds in ESI’s

Likewise, the FDA discourages the use of pharmacy compounded meds in implanted pain pump, but a large majority of pain clinics used these compounded meds.  There was recently a small study that demonstrated that two commonly used compounded opiates used in implanted pumps are losing 40% -50% of their potency by the time they have been in the pump for 90 days.

Meds pump into pumps are billed under a HCPCS codes, and the pain clinic is reimbursed the same amount regardless of what opiate they put in the pump.  It has be reported that these compounded meds can be obtained for 10% to 25% of the cost of the only commercially available opiate that is approved for use in these implanted pumps (Infumorph/Morphine) and a pump manufacturer (Medtronics) has done studies that Infumorph retains up to 90% of its potency in the pump for SIX MONTHS.

If both of these procedures are being discouraged by the FDA … could/should these services being billed to Medicare/Medicaid/Tricare be considered FALSE CLAIMS and likewise no insurance company will pay for EXPERIMENTAL PROCEDURES… so should both of these procedures be classified as EXPERIMENTAL and thus not a covered service ?

Could this FALSE CLAIMS ACT end up being a TWO-WAY STREET ?

Combating the Opioid Epidemic with the False Claims Act

https://www.americanbar.org/groups/litigation/committees/corporate-counsel/articles/2019/fall2019-combating-the-opioid-epidemic-with-the-false-claims-act/

In an effort to combat the opioid epidemic, the Department of Justice is getting more creative with the tools in its toolbox. Case in point, federal prosecutors nationwide recently started using the False Claims Act, 31 U.S.C. §§ 3729–3733, to investigate health systems’ and prescribers’ opioid-prescribing practices.

This litigation update is the first in a multipart series on the False Claims Act in the health-care context. Part 1 provides a general overview of the False Claims Act. Future updates will explore various aspects of a False Claims Act action, including civil investigative demands, the interplay with the Controlled Substances Act and other federal statutes, special considerations for qui tam actions, cooperation credit, and settlement.

General Overview of the False Claims Act

The False Claims Act is a federal civil fraud statute that dates back to the Civil War. The False Claims Act applies to parties that contract with the U.S. government and imposes liability on parties that defraud government programs. In the health-care context, the False Claims Act applies to health systems and providers that submit false or fraudulent claims for payment under Medicare or Medicaid, as well as other federally funded programs such as Tricare.

The penalties for filing false claims are steep. Violators are currently subject to civil monetary penalties of not less than $11,181 and not more than $22,363 per false claim, plus three times the actual damages incurred by the government due to the fraud. 31 U.S.C. § 3729(a)(1); 28 C.F.R. § 85.5 (2018).

The False Claims Act and the Opioid Epidemic

Government agencies, including the Department of Justice, are under intense pressure to aggressively investigate and prosecute individuals and entities that may have contributed to the opioid epidemic. To that end, the Department of Justice is, with increasing frequency, investigating doctors and health systems with a history of prescribing high quantities of opioids to patients on Medicare or Medicaid. In such cases, the Department of Justice typically alleges that the opioids prescribed were “medically unnecessary,” thereby rendering the claim for reimbursement false.

False Claims Explained

The False Claims Act creates liability for any person who knowingly presents, or causes to be presented, a false or fraudulent claim to the U.S. government for payment or approval. To act knowingly requires a person to have actual knowledge, act in deliberate ignorance, or act in reckless disregard of the truth or falsity of the information. Although acting knowingly does not require proof of specific intent to defraud, innocent mistakes and negligence are not actionable.

Notably, the False Claims Act does not define false or fraudulent. Courts, however, have found liability based on two theories: (1) factually false or fraudulent and (2) legally false or fraudulent. Factually false statements create liability for statements that themselves constitute lies. Legally false statements are those that contain falsity or fraudulence in their certifications. False certification liability arises when a health-care provider fails to comply with ancillary requirements, such as contractual provisions, statutes, and regulations.

Implied Versus Express False Certification Liability

A claim for payment to the government has both express representations outlining services or products provided and implied certifications regarding compliance with all governing rules and regulations. As such, liability may arise under either an implied false certification theory or an express certification theory.

Implied false certification liability is based on the theory that a health-care provider implicitly certifies its compliance every time it submits an invoice to the government—even in the absence of any express certifications of compliance. Liability under the implied false certification theory arises when

  1. the health-care provider submits a claim requesting payment;
  2. the claim makes representations about the goods or services provided;
  3. the provider’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes these representations misleading half-truths; and
  4. the provider had actual knowledge that its noncompliance was material.

The Supreme Court expressly adopted the implied false certification theory in 2016 in the case Universal Health Services v. United States ex rel. Escobar. 136 S.Ct. 1989 (2016) (holding that a mental health-care facility was liable for a patient’s death while the patient was undergoing treatment by doctors who lacked qualifications and licenses).

Most cases that allege liability based on medically unnecessary or unreasonable services proceed under an express false certification theory. This is because Medicare and Medicaid reimbursement forms require express certification of adherence to their guidelines. To prove liability under an express false certification theory, the government must show that

  1. the provider submitted a claim;
  2. the claim expressly certified compliance with ancillary legal requirements, such as rules, regulations, standards, or contractual terms;
  3. this claim was false or fraudulent; and
  4. this certification was material to the government’s payment decision.

Medically Unnecessary or Unreasonable Treatment and False Claims

Excluded from Medicare coverage are items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury. The Medicare Program Integrity Manual defines reasonable and necessary as:

(1)               “Safe and effective”;
(2)               “Not experimental or investigational”;
(3)               “Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is: [(i)] [f]urnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member; [(ii)] [f]urnished in a setting appropriate to the patient’s medical needs and condition; [(iii)] [o]rdered and furnished by qualified personnel; [(iv)] [o]ne that meets, but does not exceed, the patient’s medical need; and [(v)] [a]t least as beneficial as an existing and available medically appropriate alternative.

Ctrs. for Medicare & Medicaid Servs., U.S. Dep’t of Health & Human Servs. Medicare Program Integrity Manual, at ch. 13, § 5.4 (rev. 863, Feb. 12, 2019).

The Centers for Medicare and Medicaid Services (CMS) may promulgate national coverage decisions (NCDs) that may grant, limit, or exclude Medicare coverage for a specific medical service. NCDs are binding on all Medicare contractors processing Medicare claims. 64 Fed. Reg. 22619. Because coverage decisions are made at the discretion of local contractors, local contractors may also publish local medical review policies (LMRPs) to provide guidance to the public and medical communities regarding when Medicare considers an item or service “reasonable and necessary.” Id. Additionally, Medicare administrative contractors may issue local coverage determinations (LCDs), which are also binding on medical service providers. United States ex rel. Youn v. Sklar, 273 F. Supp. 3d 889 (N.D. Ill. 2017).

Absent any binding guidelines, courts generally require concrete medical, technical, or scientific context in order to allege that a treatment was medically unreasonable or unnecessary. United States ex rel. Presser v. Acacia Mental Health Clinic, LLC, 836 F.3d 770 (7th Cir. 2016).

The Medicare Program Integrity Manual empowers courts to consider accepted standards of medical practice for the diagnosis or treatment of the patient’s condition in determining medical necessity or appropriateness. Claims that are incompatible with standards of accepted medical practice may be medically unnecessary or unreasonable. E.g., United States v. HCA Holdings Inc., No. 12-20638-CIV, 2015 WL 11198933 (S.D. Fla. July 21, 2015).

Courts are split, however, as to whether poor medical judgment, without more, can create liability under the False Claims Act. Some district courts have held that a reasonable difference of opinion between physicians, without more, is not enough to show falsity. United States v. AseraCare Inc., 938 F.3d 1278, 1281 (11th Cir. 2019). The First, Fifth, and Eleventh Circuits have generally adopted the view that False Claims Act liability requires objectivity in falsity. Urquilla–Diaz v. Kaplan Univ., 780 F.3d 1039, 1052 (11th Cir. 2015); United States ex rel. Jones v. Brigham & Women’s Hosp., 678 F.3d 72, 87 (1st Cir. 2012); United States ex rel. Riley v. St. Luke’s Episcopal Hosp., 355 F.3d 370, 376 (5th Cir. 2004). The Third Circuit joins with its view that “expression of opinion, scientific judgments or statements as to conclusions which reasonable minds may differ cannot be false.” United States ex rel. Hill v. Univ. of Med. & Dentistry of N.J., 448 F. App’x 314, 316 (3d Cir. 2011).

Other courts disagree. The Tenth Circuit, for example, has noted that “it is possible for a medical judgment to be ‘false or fraudulent’ as proscribed by the FCA.” United States ex rel. Polukoff v. St. Mark’s Hosp., 895 F.3d 730, 742 (10th Cir. 2018). The Sixth Circuit has similarly noted that “opinions are not, and have never been, completely insulated from scrutiny. At the very least, opinions may trigger liability for fraud when they are not honestly held by their maker, or when the speaker knows of facts that are fundamentally incompatible with his opinion.” United States v. Paulus, 894 F.3d 267, 275 (6th Cir. 2018).

Conclusion

Health systems and prescribers must be cognizant of the fact that the Department of Justice is using the False Claims Act to combat the opioid crisis. To ensure compliance with the False Claims Act, health systems should monitor the prescribing practices of its providers and implement policies and procedures governing the prescribing of opioids.

Sean Bosack is a shareholder and Nina Beck is an associate at Godfrey & Kahn, S.C. in Milwaukee, Wisconsin.

Losing Faith in My Profession

I can so relate to the situation that a daughter/son/husband/wife can encounter with a loved one in a healthcare facility (hospital, physical rehab, nursing home, etc, etc).  More times that I wish  when Barb has been in a facility and I have had to bring into the conversation that ” I’m am a Pharmacist” to get the attention of the staff that are suppose to be attending to her health needs and they are NOT DOING THEIR JOB !  Unfortunately, not every first contact with the facility’s staff gets results, but those staffers tend to under estimated my tenacity. I really don’t care how many times I have to take my concerns to someone above the person I am talking to.    Generally, at sometime going up the corporate ladder someone is going to get pissed that my concerns have gotten to their level and the person under them did not take care of my concerns about inadequate care being provided my wife.

To get proper care for my mother, did I really have to tell everyone I’m a doctor?

https://www.medpagetoday.com/blogs/kevinmd/85249

I believe in the practice of medicine and enjoy teaching others this amazing art. However, after experiencing nine months of interactions through medicine as the daughter of a sick patient, I struggle with my pride in the profession and fear of the healthcare system.

My mother would proudly tell all her physicians that her daughter was a doctor. I knew she was proud, but I didn’t believe in using my title to change the care she received. That belief changed when she became sick.

The first time I exploited my title, senior specialists at another hospital tried to perform a procedure and weren’t successful. Upon arrival at the new hospital, my mother politely asked the ICU residents not to attempt the procedure without the attending in the room. The residents glibly responded, “we are the A team – and he’ll be out there.” When they didn’t listen, she looked at me with fear. I walked out and spoke with the attending. I said, “I am a doctor, and I train residents. Your residents aren’t listening to their patients.” After my explanation, he stopped what he was doing, unsuccessfully attempted the procedure, and came up with a different plan that prevented my mother from having additional pain.

When discharged from the hospital, the physician team did not know how to help us obtain sufficient home healthcare. I called a friend, a physician leader in the organization, and found she could help us. She knew the keywords to say and who to ask for. This personal, professional connection allowed my mother to immediately have home health.

I took my mother to the emergency room after I showed up to her house and found blood clots in the place of what she thought was diarrhea. I cleaned it up before we got in the car. I saw how much blood she lost. I personally provided the admitting resident her history. I knew her new medications and potential side effects. I knew her lab results from the previous week. I could do the math. Based on her new results, she lost the equivalent of 4 pints of blood in the past 4 hours, and she was still bleeding. The resident told me she didn’t need a transfusion. When the resident was not open to the idea of a blood transfusion, I used my title. I called her cardiologist on his cell phone and told him the situation. He logged into the medical system, and the next thing I knew, the transfusion had been started.

On my birthday, my mother rapidly decompensated. I was renewing my CPR license as a cardiac resuscitation was called. I arrived at the hospital, and the resident gave me basic information. My mother’s cardiologist used my title. He said, “No, she is a doctor. She deserves a more thorough update. You will keep her fully updated.” This resident tried, but I also received personal updates from the cardiologist.

So it continued. During every hospital visit, I mentioned my title to someone to ensure proper care or communication. My title was required to ensure the care my mother deserved as a patient.

In her final week, my mother suffered a massive stroke. I was coming to terms with the biggest decisions I made for my mother. It was time for her to officially change her status to DNR. I even had medical power of attorney forms in hand. I asked to sign papers to this effect and was told that wouldn’t be necessary. Knowing this wasn’t accurate, I used my title with the nurse to ensure I would receive an immediate call if anyone tried resuscitation. I signed paperwork to withdraw all care the next morning. The dialysis technician wheeled in the dialysis machine. I said, “No, she doesn’t need that. I have withdrawn care.” After several minutes of arguments, I finally said, “I am a physician, I know that I have the right to refuse.” Similar conversations occurred with the neurosurgeon, who was recommending aggressive medical management, the nurse who wanted to check her blood sugar, and the resident who tried to talk me out of the decision to transfer to hospice.

The final time I used my title, was when I asked the team to complete FMLA paperwork. I watched the resident quickly flip through the paperwork and called his attending, upset by the amount of work involved. He came back out and said, “Well, the family member has to complete this.” I responded, “Did you read this? The family section is complete. All you have to do is write her diagnosis here and that she was here in the ICU. You indicate unknown time.” He responded that he didn’t have the time to complete this form today. I asked him if he knew I was a physician, and he looked up startled. I said, “As an attending who teaches residents, I hope my residents never treat families how you just treated me. You just told me that you don’t have time to ensure that I can be by my mother’s side during her final days.” Trembling in anger, I walked away to the hospice unit. Although that resident did not help me, after sharing my story in the hospice unit, they ensured my paperwork was done within two hours of our arrival.

My mother had many healthcare interactions in her final nine months. I have no regrets for using my title to ensure the best care. I regret the necessity. I regret that a patient’s wishes weren’t respected and that she needed a physician daughter advocate. I fear for patients without physician daughters who understand the system or have colleagues who know code words. I regret that I carried my title of physician, and was not just a daughter, holding her mother’s hand in the final months of her life.

Santina Wheat, MD, is a family physician.

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed –Pharmacies: It’s Not Their Fault

Pharmacies have started turning away people with opioid prescriptions, or giving them half-doses because the pharmacies are being shorted by distributors . But the Pharmacies are trying but you don’t receive your shipment of automobiles you’re not gonna sell any cars. If distributors decide without your permission or standardization with the help of analytic hired guns invent percentage of narcotics vs store sales this is terrorism. When did distributors get this much power to ration pain medicine your business fails. State pharmacy boards are the real ones you should be contacting about opioid pain prescriptions, or lack there of. The more people who do, the stronger the message will be painful disease pain patients should not have their lives ruined because of the belief if you reduce substance your reduce addiction which we all know is not true

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

https://pharmacistactivist.com/2020/March_2020.shtml

Most of the responses I received to Part 1 of the series of editorials (February issue of The Pharmacist Activist) on this topic are from two groups of individuals. Current and former CVS pharmacists and technicians voice appreciation for the extended awareness and concern about the working conditions imposed by their management that increase the risk of errors. They also express their gratitude to Ellen Gabler, the New York Times (NYT) investigative reporter, for recognizing and exposing the stressful work environment they experience and the resultant risks for consumers. I also hear from many pharmacists at Rite Aid, Walgreens, and Walmart with the request, “Don’t forget us – our working conditions are as bad as those at CVS.” I recognize that and many of the comments that I make about CVS in these editorials apply equally to those chain stores. However, CVS, with its huge network of stores combined with its Caremark and Aetna components, is responsible for the greatest risk for harm for consumers and is the most potent destructive force in pharmacy.

Updates

Much has happened in the short period of time since I published Part 1 of this series. Ellen Gabler has published a follow-up report, “Walgreens Had Consultants Cut Staff Complaints About Errors,” in a page 1 (A1) story in the February 22, 2020 print edition of the NYT. This story also addresses additional concerns involving CVS stores, as well as responses from CVS to the first story in the NYT. Hundreds, if not thousands, of comments have been posted on certain social media sites. And then, there is the editorial commentary in Chain Drug Review, “Retail pharmacies will overcome biased story.” Although this latter commentary is supportive of the role of and trust in pharmacists, it includes the following comments that must be challenged:

Chain Drug Review (CDR): “As The New York Times has been doing of late with astonishing regularity and surprising frequency, the newspaper of record has at last gotten round to demolishing the retail pharmacy business.”

The Pharmacist Activist (TPA): The NYT article pertains to concerns and errors in chain pharmacies, and does not focus on the entire “retail pharmacy business.” The NYT article addresses errors in the context of “chaos” and working conditions in chain pharmacies. It provides readers with information that is important for them to know for their own protection. It is not an attempt to “demolish” chain pharmacies. To the contrary, any “demolishing” is self-inflicted by the chains. If they did that just to themselves, it would be for the betterment and safety of the public. However, unfortunately, the policies and actions of the chains are destructive for the entire profession of pharmacy, as well as for consumers.

CDR: “They (pharmacists) are, at times, overworked and overlooked, unreasonably and unfairly called upon to multitask.”

TPA: “At times?” “Frequently” would be more accurate and some chain pharmacists would respond “all of the time.” CDR: “When they (pharmacists) complain, as they frequently did in this article (NYT), it is often anonymously, at a time when using their name and identifying the retailer for whom they work might have helped curtail or control the mistakes that do occur.”

TPA: Chain pharmacists who use their names and identify their employers will be terminated, but for an alleged violation of some company policy in an attempt to prevent the termination from appearing retaliatory. Even pharmacists who are no longer employed in a chain pharmacy are fearful of criticizing their former employers because of concerns they will find some way to retaliate.

CDR: “Typical of the Times, as it is much of print journalism, this article is long on criticism but woefully short on suggestions for appropriate action. The story leaves the cures for this unacceptable malady to the retailers…”

TPA: I fully agree that the current situation is “unacceptable.” However, it is not the responsibility of the Times to provide suggestions for appropriate action. Chain pharmacies have created the terrible working conditions that increase the risk of errors and harm, and it is chain pharmacies that should take the appropriate actions. However, it is clear that they don’t and won’t, and they have no basis for the complaint that the Times is exposing the errors and other problems the chains want to cover up. It is also noteworthy that the CDR does the same thing for which it is criticizing the Times by not providing suggestions for appropriate action. However, The Pharmacist Activist does have recommendations for appropriate action which are provided later in this editorial.

CDR: “And if one patient passes on by swallowing a drug not prescribed or dispensed to treat the malady the proper drug is generally used to treat, that’s reprehensible.”

TPA: I fully agree, and “passes on” sounds so much better than “died” or “killed.” The terminology is also a factor in identifying the frequency with which errors occur in CVS and other chain pharmacies. CVS contends that errors are “rare.” The CDR commentary initially notes that errors occur “occasionally,” and then “not often.” There is a trend here and many CVS pharmacists would say that the most accurate designation is “frequently.”

Consumers at risk

CVS places millions of consumers at risk of harm from inappropriate or less-than-optimal drug therapy by failing to provide them with the counseling and services its pharmacists are in a position to provide. CVS management denies this assertion or blames its pharmacists, but their denial is contradicted by the inadequate staffing of pharmacists and technicians, the stressful workplace environment, and the lack of adequate time for pharmacists to speak with patients. In the most serious situations, consumers experience adverse events, some of which are fatal, as a consequence of preventable errors and other drug-related problems.

Many errors are not even known or recognized, either because there are not consequences, or consequences occur but an error is not suspected and the resultant problem is attributed to another explanation. When errors are discovered but harm has not occurred or the consequences are considered “minor,” consumers are placated with sufficient coupons for store merchandise or other incentives to “resolve” the experience.

Some errors that result in harm are so clear and indisputable that CVS will compensate the victims in an amount sufficient to avoid lawsuits. Errors that do result in lawsuits rarely become known to the media, the public, or even state Boards of Pharmacy, because they are settled out of court with the settlements being sealed with confidentiality restrictions. In some settlements the terms even permit the defendant chain pharmacy to “acknowledge no wrongdoing,” the accurate translation of which would be “there was wrongdoing.” While claiming that errors are “rare,” CVS stonewalls requests to provide information/data regarding errors, as it did in responding to the reporter for the NYT. However, the outrage is increasing and the stone wall is starting to crumble. A rhyme comes to mind that is ripe for paraphrasing:

CVS sat on a crumbling wall;
CVS had a great fall;
All the CEO’s millions,
And all the CEO’s men and women
Couldn’t put CVS together again!

Can a rhyme become reality?

Recommendations

Much more must be done to expose preventable medication errors and other drug-related problems, as well as irresponsible decisions of the executives of chain pharmacies. Ellen Gabler and the NYT have pulled open the veil of secrecy that has hidden these problems, but the momentum of increasing disclosure must not diminish. There are steps that can be taken now and the following recommendations are provided:

  1. Pharmacies must report to the state Board of Pharmacy medication errors that cause harm and/or require increased patient monitoring. The definition of medication errors and risk assessment index established by the National Coordinating Council on Medical Error Reporting and Prevention (NCC MERP) should be used for the reporting of errors in the following categories to the Board:
    Category D: Errors that result in the need for increased patient monitoring but no patient harm;

    Category E: Errors that result in the need for treatment or intervention and caused temporary patient harm;

    Category F: Errors that result in initial or prolonged hospitalization and caused temporary patient harm;

    Category G: Errors that result in permanent patient harm;

    Category H: Errors that result in a near-death event (e.g., anaphylaxis);

    Category I: Errors that result in patient death.

    Boards of Pharmacy must be accountable in enforcing the reporting of errors, assessing the risk factors, and taking appropriate action.

  2. Standards/guidelines must be established to assure the level of staffing of pharmacists and pharmacy students and technicians that is appropriate for the number of patients served and/or prescriptions dispensed during a specified period of time. There are too many variables to establish specific quantitative requirements of this type, but the appropriateness of the level of staffing must be assessed as a potential contributing factor when errors occur. The number of patients served during a particular period of time, whether or not a prescription is dispensed for every patient, would be the best parameter to assess whether a pharmacist has sufficient time to fulfill her/his responsibilities to patients. However, this parameter is not used in current pharmacy practice, and the number of prescriptions dispensed during a particular period of time should be used initially as a less satisfactory but adequate measure. I propose the following guidelines:
    An average of 15 prescriptions per hour per pharmacist (i.e., one every 4 minutes, 120 in 8 hours, 150 in10 hours, 180 in12 hours) should be identified as the number of prescriptions that can be dispensed by a pharmacist that is consistent with obtaining and reviewing pertinent patient information, accurate preparation and dispensing of the prescription, patient counseling, phone calls, supervision of pharmacy students and technicians, and other responsibilities.

    Some will respond that this number is too high and some will respond that is too low. The number should be applicable whether the pharmacist is working alone, or with any number of pharmacy students and technicians whom the pharmacist must supervise.

    The proposed average of 15 prescriptions per hour per pharmacist can be, but would not be required to be a criterion for an employer to determine the number of hours of staffing of pharmacists and pharmacy students and technicians. However, when a medication error in one of the above categories occurs and is reported to the Board of Pharmacy, the description of the error must be accompanied by documentation regarding the number of prescriptions dispensed on the date the error occurred and the number of hours of staffing of pharmacists. In addition to any disciplinary actions taken by the Board with respect to the nature and severity of the error, additional penalties/actions should be imposed if the average of 15 prescriptions per hour per pharmacist is exceeded by more than 20%

  3. Pharmacists who are employed by for-profit corporations that are not owned by pharmacists should not be eligible to serve on a state Board of Pharmacy. The responsibilities of members of a Board of Pharmacy are to protect the interests and safety of the citizens of the state with respect to the licensure and practices of pharmacists and pharmacies, and conflicts of interest can occur when the priorities of a corporation are not consistent with those responsibilities.
  4. A communications network should be established in which chain pharmacists can participate anonymously (i.e., Chain Pharmacists Anonymous Network [CPAN]), because of their fear of retaliation if they voice concerns. This initiative should start with CVS pharmacists and subsequently be expanded to include pharmacists employed at other chains.
  5. The profession of pharmacy should appeal to the Federal Trade Commission and Department of Justice to require divestment of Aetna and Caremark from CVS, as well as similar actions for other corporations that have acquired anticompetitive and excessively dominant positions in pharmacy and health care.

Part 3 of this series will focus on the experiences of CVS pharmacists and technicians, and the destructive effects that CVS has had on the profession of pharmacy.”

Daniel A. Hussar
danandsue3@verizon.net

PBM: why your prescription COSTS TOO DAMN MUCH !

PBM Express Scripts: PROFITS TRIPLED TO $4.5 BILLION in just 4 years, while REVENUES DECLINED AND PRESCRIPTIONS PLUMMETED? How Possible?

https://drugpricetruth.org/pbm-express-scripts-profits-tripled-to-4-5-billion-in-just-4-years-while-revenues-declined-and-prescriptions-plummeted-how-possible/

There is only one explanation – A massive increase in secret “fees” from their drug company collusion “partners”, directly tied to skyrocketing U.S. brand drug prices/price increases, FOR DOING FAR LESS WORK.

Below are the shocking financial numbers for the top pharmacy benefit manager (PBM), Express Scripts, from their own financial statements on file with the Securities and Exchange Commission (SEC).

Express Scripts is now part of Cigna, after more mergers (including CVS/Aetna)  that only worsen the public harm, while serving to increase the secrecy of the ongoing simple pharma/health insurer/PBM “fee” price collusion scheme.

Remember, pharmacy benefit manager (PBM) is just a long-winded term for the insurance company that is supposed to manage the drug part of our health plans. Their main purpose is supposed to be getting us all lower drug prices (i.e., rebates, another name for discounts) from pharmaceutical companies. Unfortunately, rather than doing their job, they have been secretly colluding with drug companies to massively raise U.S. brand drug prices and profits for themselves, while passing the costs on to us. The simple scheme began long ago with Medicare Part D. Very sad and very harmful, but true.

After recent mergers, all the dominant PBMs are now part of the four dominant broader health insurers (United Health/Optum, Cigna/Express Scripts, CVS/Aetna and Humana) that control 80-90% of  private US drug plans and Medicare Part D. You can now mostly just use the term dominant health insurer and ignore PBM.

And even if these big four health insurers are not listed by name on your health/drug plan, one of them is likely involved as a partner behind the scenes with your prescriptions. Lots of side partnerships as well. Check your insurance card or other fine print.

Express Scripts’ Financial Information
                                            Revenues       Prescriptions           Profits              Employees
2013                                   $104 billion          1.2 billion                 $1.8 billion              29,975
2014                                   $101 billion          1.06 billion                $2.0 billion             29,500
2015                                   $102 billion          1.04 billion                $2.5 billion             25,900
2016                                   $100 billion          1.0 billion                   $3.4 billion             25,600
2017                                   $100 billion          0.99 billion                 $4.5 billion             26,600
Change 2013-17                     -4%                     -18%                               +150%                  -11%

The obvious question:

How could Express Scripts have nearly TRIPLE ITS PROFITS TO $4.5 BILLION in just four years from 2013 to 2017.…

– While its number of prescriptions for patients dropped -18%?

– While its number of employees dropped -11%?

– While its total revenues dropped -4%?

By the way, Express Scripts revenues and prescriptions were falling because it was losing market share to the other dominant health insurer/PBMs, especially CVS and UnitedHealth.

So Express Scripts was losing clients and business in a big way, but still had no problem massively increasing profits? Really?

Common sense would tell you that this would not be possible in a legitimate market.

And you would  be dead right.

So how could this have happened?  – Again, nothing complicated.

All due to the simple, but secretive, pharma/health insurer/PBM “fee” scheme at the center of my false claim (qui tam) whistleblower cases – the two largest healthcare whistleblower cases in history.

Express Scripts is getting paid a lot more money from drug companies, for doing a lot less work – all driven by massive price increases on U.S. brand drugs, which account for 85% of Express Scripts’ sales

By the way, no surprise or mere coincidence that this bizarre surge in Express Scripts’ profits began in 2013, just following its merger with Medco (the prior largest PBM) in 2012. That is when the PBM industry became super-concentrated and the price collusion “fee” scheme with pharma accelerated across the nation.

How does the “fee” scheme work? I already sound like a broke record on this website, even though it is less than two months old.

Pharma “fees” paid as a “percent” of uniformly and massively increasing “sticker” or “list” U.S. brand drug prices, especially for top-selling multiple sclerosis, diabetes, cancer, rheumatoid arthritis drugs.

By law, these pharma “fees” are supposed to be for helping patients. More patients, more support and more “fees”. Right? A very basic concept. Makes sense.

Instead pharma and Express Scripts shockingly decided to structure these secret national “fee” contracts as a “percentage” of massive brand “sticker” prices and price increases.  All began a long time ago with Medicare Part D.

How am I sure? Because I heard it directly from the industry insider’s doing it! A long time ago now and it has gotten a lot worse. Now a national crisis.

In October 2013, I attended an industry “fee” conference (the only one I am aware of) for two days at which 50-60 pharmaceutical/PBM executives, and their close legal and consultant advisers, admitted the whole thing in colorful detail.

I sat in the front row with another colleague and took 80 pages of notes while aghast. I had already been following these drug and health insurer/PBM companies closely for 20 years as a professional analyst at that point and never heard of these secret “fee” payments before. And these company are still hiding it to this day, with a lot of help unfortunately.

Read about this shocking insider conference  in the whistleblower documents at this link: /wp-content/uploads/2020/03/SDNYComplaintFeeConference.pdf

Here are a couple of the definitive firsthand insider comments I heard at the conference which verified the simple scheme:

Secret “pharma fees” (as a percent of brand drug “sticker” prices) were the PBM’s “main source of income”
“When would the government be ‘dangerous enough to understand how industry works”
“I hope the conference was not being recorded”

Just these three firsthand insider quotes sum it up, but there are lots more.

To my shock and dismay, the Justice Department admitted repeatedly to me and my attorney that it never interviewed under oath any insiders from the conference in its 4-year investigation of my whistleblower cases.

As a non-insider at these companies, these firsthand witnesses from the definitive insider conference were the reason I filed the whistleblower cases promptly in the public interest starting in January 2014, with the Justice Department’s support.

Making the simple scheme even more ridiculous and abusive, for many of the old top-selling U.S blockbuster brands, Express Scripts and the others have gotten massive increases in “fees” routinely for drugs that are plummeting in use by physicians and patients.

Biogen’s Avonex (multiple sclerosis): 10-fold “sticker” price increase (to $100,000/patient now) with “fees” to health insurer/PBMs attached, while Rxs are down -60-70% over the past decade. Really?

Hard to imagine Biogen’s and numerous other pharmaceutical companies’ executives doing this with any kind of conscience?

Even harder to imagine these executives deceiving all intentionally for a decade-plus while accelerating the scheme amid wide-ranging patient/public harm and outcry?

And getting away with such a preposterously simple scheme causing massive patient and public harm for 15 years? Perhaps the most shocking of all.

Same ridiculous dynamics for many other old blockbuster U.S. brands, including Amgen’s Enbrel (rheumatoid arthritis), Teva’s Copaxone (MS), Novartis’ Gleevec, Eli Lilly’s Humulin (insulin), Pfizer’s Viagra (impotence) and Premarin (hormone), etc.

So, Biogen and many others paying the PBM/health insurers 5-10 times as much in “fees” for “supporting” half or less as many patients and prescriptions over more than a decade now? Really?

And what other magic did Express Scripts’ management perform to generate massive profits and pump its stock price, while its business was in free fall between 2013 and 2017?

Again, simple. Massively cut spending for “supporting” patients and get rid of employees.

Easy to do when your surging profits are just for passing through pharma’s price increases to your own trusting clients, patients and taxpayers whom you have pledged to protect, while doing far less work.

Express Scripts cut its “support” costs (called S,G&A in the financial world) by 30%, from $4.6 billion to in 2013 to $3.3  billion in 2017.

As Dire Strait famously said: Money for Nothing.

Less than nothing in this case! More Money for far less work!

And to further help its earnings per share (EPS) and the stock price central to massive Express Scripts’ executive compensation packages?

Use a lot of the free money from the pharma “fees” to buyback massive amounts of stock.

Express Scripts’ shares outstanding decreased 30% from 2013 to 2017.

While its corporate profits surged 150% in just four years as its legitimate business was plummeting, Express Scripts’ EPS went up even more!

Express Scripts EPS went up 230% between 2013 and 2017 –  for a business in sharp decline! Really?

In the end, I return to the remarkably simple nature of this secretive financial scheme and national crisis orchestrated by just a handful of misguided executives.

It really is just printing illicit money, profits and huge stock compensation packages for a very few executives, while they guard the secret like King Tut’s tomb.

I remind people that 99% of the hardworking people in the pharmaceutical and health insurance industries know nothing about this highly centralized secretive scheme harming all Americans across the nation.

And based on their own feedback,  very few health insurer/PBM employees are benefiting from the massive profits or like what is going on at these companies.

In July 2015, Express Scripts was ranked as “the worst company to work for in the United States”, according the reviews of its own employees on the Glassdoor career website. CVS was ranked the 12th worst company to work for in the country. See link: https://www.pharmacytimes.com/news/express-scripts-cvs-rank-in-worst-companies-for-workers

Quite an accomplishment for both Express Scripts and CVS, since Glassdoor includes the self-reported employee reviews for 400,000 companies around the world.

The prices of these old MS, cancer, rheumatoid arthritis and insulin drugs are now 5-10-fold or more higher in the U.S. compared to major European and other countries.

There are no PBMs outside the United States.

These brand drugs were the same price in the U.S. and Europe when this simple “fee” scheme began when these dominant PBMs were entrusted by Congress and the American people to manage the vital Medicare Part D program.

Instead, the PBMs chose to secretly partner with pharma to massively raise U.S. brand drug prices for profit rather than protect American citizens.

That about says it all regarding the real “value” that PBMs are providing to U.S. patients and taxpayers, despite their endless self-promotional public rhetoric to the contrary.

Money for Nothing.

No – Money for Far Less than Nothing.

Money for Severe Harm.

I would greatly appreciate your sharing this blog post and the website. Thanks for your interest.  

I remain hopeful that other experienced healthcare professionals will eventually help end this abuse. Unfortunately, that has not happened yet despite my repeatedly contacting many of them.

Regardless, the main goal of my efforts and this website is to inform and engage the broader American public.

Please share this with any and all. We are all being harmed and are in this together.

“PEOPLE OVER PROFITS”

I would be glad to speak with any interested party. I can be easily reached by email at info@drugpricetruth.org.

John R. Borzilleri, M.D.