Dr. Thomas Kline, MD, PhD: Medical Myths Revealed Myth 15: Many people die from respiratory depression taking their opioid medicines

Based on our research, it maybe almost no-one. Officially the figures from the six citations in the CDC guidelines indicate the rate is 0.02%, which is a tiny number. which is about 500 to 1000 a year taking prescription drugs in the US. this number is so small, that it makes it very rare. Probably as rare as a fatal reaction to aspirin. In order to prevent an overdose from prescribed opioids, You would have to reduce or eliminate pain prescriptions, and the other 5,000 people who will not be listed as opioid overdose. almost all overdoses CDC listed were Heroin addicts not getting treatment.

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: 3-15-20 FILL MY PRESCRIPTION PLEASE.

It is your job. No more excuses. More than half of us are ADA disabled, We are a protected class. Sounds like the days of WE RESERVE THE RIGHT TO REFUSE SERVICE remember that? Ok you take your valid pain prescription in “we are uncomfortable” or “out of state” or more than 40 miles, a discriminating pharmacy in Raleigh. Raw ADA discrimination. File with ACLU, Civil rights, ADA right to have pain treated. A fill law is needed nationally Fill all , if not file report as to why not.

non profit spends 3+ million per year in PENN on opiate crisis.. while chronic painers write, phone call politicians – who do you think is winning ?

AllOne Foundation Combats the Opioid Crisis

https://www.news-line.com/PH_news30200_enews

In 2018 alone, more than 4,400 people died from drug overdoses in Pennsylvania. While this number represents an 18 percent decrease from 2017, the number of drug-related deaths that occur each year is an issue we are still facing in our communities.

AllOne Foundation is working to save lives and reduce the economic, social, and criminal justice costs of the opioid epidemic. After extensive research and countless town hall meetings, AllOne Foundation developed and is executing a successful, scalable, and sustainable philanthropic strategy on this issue.

“AllOne Foundation is providing leadership on a strategy that includes the distribution of over $6,000,000 in funding to various organizations that service our community members in targeted areas that include education from elementary through college, addicted moms and infant recovery, alternative enforcement, prevention and improved access to treatment.” Stated Atty. John P. Moses, Chairman, AllOne Foundation.

On October 2, 2019, AllOne Foundation held the Opioid Crisis Solutions Symposium unveiling strategic plans with keynote speaker Attorney General Josh Shapiro:

“The opioid epidemic is the number-one killer in Pennsylvania. Every day, 15 Pennsylvanians die from an opioid overdose, and this health crisis doesn’t discriminate. We have to recognize the path between the pills doctors prescribe and the cheap bag of fentanyl found in the streets. And we have to be vigilant as we act to tackle this problem. I am grateful for the partnership with the AllOne Foundation to help stop this serious problem,” Attorney General Josh Shapiro delivering the keynote address at AllOne Foundation’s Opioid Crisis Solutions Symposium

The Opioid Solutions Symposium addressed key strategic target areas including: Addicted Women & Infant Recovery; Alternative Enforcement; Education & Prevention; and Improved Access to Treatment. The businesses and organizations within Northeastern Pennsylvania that have taken a lead in fighting the opioid crisis and coming together in a unified effort are The Wright Center, Treatment Court Advocacy Center (TCAC), Luzerne County Community College (LCCC), and the Children’s Service Center (CSC). A unified collaboration between so many organizations involved in this effort is uncommon, but necessary. “We have all come together to develop solutions to this horrible crisis that we are all facing.” States John W. Cosgrove, the Executive Director at AllOne Foundation.

The Wright Center developed the Healthy Moms program providing intensive intervention for addicted mothers. Judge Michael Barrasse is the immediate past Chairman of National Association of Drug Court Professionals and spearheads Treatment Court throughout the region and in particular rural areas. LCCC launched the first Institute for students in recovery because data evidences that students maintaining an educational tract have the greatest sustained recovery rates. CSC places drug specialists into elementary schools identifying high risk students and implementing wrap around services for the child and their families.

AllOne Foundation is a private foundation whose mission is to enhance the present healthcare delivery in Northeastern and North Central Pennsylvania. The Foundation crafts new ways of improving the health and welfare of people. Over $16,000,000 has been distributed since the inception of the Foundation five years ago. Each year, an impact area is identified with a goal to unite organizations in a collaborative effort to create measurable, innovative and highly effective programs. The impact areas have been Behavioral Health, Women & Children, Autism, and Opioid Solutions. The impact area identified for 2020 will be Food Security as well as providing new funding and resources to the other impact areas.

For more information, contact Mary Carroll Donahoe, AllOne Foundation & Charities, at 570-208-1203, or via email at mcdonahoe@allonefoundations.org

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed

https://youtu.be/c_8dnCiztcY

We have uncovered a serious problem explaining why disabled rare disease patients are being denied their pain medicines, Fear of addiction phobia strikes again – now drug distributors are not allowing pharmacies to go over their averages or more deaths more addicts – nope flawed policy by the US government trying to cure the problem of opiate crisis by sacrificing voters with just terrible terrible disease. Call your federal senators and reps the distributors are strangling my patients! and all you out there – ask you pharmacists if wholesalers are choking their business and your necks!

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.