“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Feds to Stop #Pharma ‘Rebates’ to #PBMS, But President Biden Delays.
The Department of Health and Human Services #Removed the ‘Safe Harbor’ Protection from the #AntiKickback Statute for Drug Rebate Payments to PBMs.
**Note Trump Initially Put New Regulation in Place and Biden Has Delayed it Until 2023.
In Other Words, Drug Companies Must Stop Giving Their Rebate Payments to PBMs and Give them Directly to #Seniors on #Medicare Instead.
A Study Estimates that These Rebate Payments to Seniors Would #Save Them $381 – $1,522 Per Person Per Year.
To Potentially Circumvent This Regulatory Change, the PBM Express Scripts (Now Part of Cigna) Started a Group Purchasing Organization (#GPO) Called Ascent Health Services that is Based in Switzerland.
Why?
Reason: Pharma Companies Can Still Pay ‘Administrative Fees’ (in place of Rebates) to the PBM’s GPO Because GPOs Are Still Protected Under #SafeHarbor from the Anti-Kickback Statute.
@CVS Has Started Their Own GPO Called Zinc as Well.
#InsuranceCarriers and PBMs DO NOT Need to Follow These New Regulations When It Comes to Their Employer Clients and their Employee Health Plans–the Rebate Payments to PBMs Can Remain.
I can see when there is a “postmortem ” of this mutation of the COVID-19 virus, it will be concluded that – as has already been stated – with this mutation many infected people are asymptomatic and thus continue with their normal day to day life and thus this mutation is being more easily spread.
Omicron Cases Soar, but Deaths on the Decline, White House Says
Cases of the highly transmissible Omicron variant continue to skyrocket, but hospitalizations and deaths remain much lower by comparison ― another sign that Omicron is less deadly than previous strains, White House officials said on Wednesday.
“The rapid increase of cases we’re seeing across the country is, in large part, a reflection of the exceptionally transmissible Omicron variant,” CDC Director Rochelle Walensky, MD, said at a White House briefing. “While our cases have substantially increased from last week, hospitalizations and deaths remain comparatively low right now.”
“This could be due to the fact that hospitalizations tend to lag behind cases by about 2 weeks, but may also be due to early indications we’ve seen from other countries like South Africa and the United Kingdom of milder disease from Omicron, especially among the vaccinated and boosted,” she continued.
The 7-day daily average of COVID-19 infections is 240,400 ― an increase of 60% since last week. But hospital admissions have only increased by 14%, at 9,000 per day. Deaths are averaging 1,100 per day, a decrease of about 7%.
Early data from other countries aligns with this trend, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease and medical adviser to President Joe Biden. According to a study from one South African hospital published Tuesday, patient deaths from Omicron averaged 4.5%, compared to 21.3% from previous waves. About 45% of patients with Omicron required supplemental oxygen, while 99% of patients from previous COVID-19 waves needed breathing assistance. The average length of stay for Omicron patients was 4 days ― less than half the average for other strains.
Fauci noted that while the Omicron variant seems to replicate faster in the bronchial tubes, this occurs much more slowly in the lungs, which could account for the milder disease.
Both Walensky and Fauci stressed that those with vaccine protection are far less likely to become infected with Omicron and are less likely to be hospitalized and die should they be infected.
“The risk of severe disease from any circulating variant, including Omicron, is much, much higher for the unvaccinated,” Fauci said.
Walensky also addressed the controversial updated guidance reducing isolation time for infected health care workers, along with looser guidelines for people exposed to COVID-19 and those infected without symptoms.
“Let me make clear that we are standing on the shoulders of 2 years of science, 2 years of understanding transmissibility, and a lot of information that we have gleaned from the wild type virus, as well as the Alpha and Delta variants, and more that we continue to learn every single day about Omicron,” she said. “Studies have demonstrated that when people are infected with SARS-CoV-2, people are most infectious the 1 to 2 days before symptoms develop, and the 2 to 3 days after. After 5 days, the risk of ongoing transmission substantially decreases.”
Sobering numbers as this troubled year draws to a close:
505,013,980 coronavirus shots injected in the U.S. and territories[1] 983,756 reports of injury to VAERS 20,622 reports of death 34,615 reports of permanent disability 3,365 reports of miscarriage following coronavirus vaccinations.
And yet, All-cause mortality is higher in 2021 than in 2020. COVID-19 deaths are higher in 2021 than in 2020. New coronavirus cases in the U.S. just reached a record high.
The data is the data and by every objective measure the coronavirus vaccine campaign has failed.
Thank you to everyone who shares OpenVAERS with others. This information is getting through to policy makers and the wider public. We appreciate your encouragement and moral support for this work.
Dr. Xiulu Ruan practiced medicine as a board‐certified pain specialist in Mobile, Alabama. His practice served almost 8,000 patients and employed 57 people. In 2016, he was indicted for unlawfully distributing controlled substances (opioids) and many related criminal charges. At his trial, the government argued that some of Dr. Ruan’s prescriptions fell “outside the usual course of treatment” and called numerous experts to testify to that claim. Dr. Ruan countered with his own experts who testified that his prescriptions were medically valid.
A jury convicted Dr. Ruan based on jury instructions that did not include a “good‐faith” defense for doctors who truly believe they are practicing good medicine.
The Eleventh Circuit, unique among all the circuits, does not allow a good‐faith defense, meaning doctors can be convicted of serious crimes—Dr. Ruan was sentenced to 21 years in prison—for merely being negligent in how they write prescriptions. And doctors of course disagree in good faith on the proper standard of care all the time, but malpractice claims adjudicated by civil courts are the proper venues to punish doctors who are merely negligent in their medical practice.
The Eleventh Circuit upheld Dr. Ruan’s conviction and he appealed to the Supreme Court, which agreed to hear his case. Cato has filed an amicus brief in support, arguing that the Controlled Substances Act (CSA) requires a good‐faith defense to differentiate between doctors who are earnestly practicing medicine and those who distribute controlled substances without a medical purpose—i.e. “pill pushers” or “pill mills.”
Over 100 years ago, the Harrison Narcotics Act became the first major federal drug law. It ended the practice of over‐the‐counter opioids and cocaine while allowing various medical professionals to distribute the drugs “in the course of his professional practice only.” The Harrison Act was a tax law, and it was enforced by the Treasury Department. Within a few years, treasury agents were prosecuting doctors who were alleged to have prescribed opioids to patients in order to maintain their addictions.
The Supreme Court heard many challenges to the Harrison Act from various doctors who were charged under it. In 1919, the Court ruled that prescribing “maintenance doses” to people who were addicted to opioids did not qualify as a legitimate medical purpose. At no point, however, did the Court assume that a good‐faith defense was not available to doctors who legitimately believed they were practicing good medicine.
That interpretation carried over to the CSA, which became the main federal drug law in 1970. We argue that allowing doctors to use a good‐faith defense is not only historically justified, but it is essential to keeping the CSA within proper constitutional boundaries. States retain the power to regulate the medical profession under their traditional police powers. Without a good‐faith defense, the CSA comes close to unconstitutionally regulating the medical profession. Disagreements over standards of care are properly adjudicated in state courts, and federal jurisdiction should only kick in when a doctor has abandoned the subjective intent to practice medicine and become a drug dealer.
Moreover, prosecuting doctors for “misprescribing” has become so common that many doctors are afraid to prescribe opioids. Yet there is no agreed‐upon standard for “misprescribing,” especially when it comes to chronic pain patients, of which there are about 20 million in the country. The standards are so vague that doctors don’t know when they have crossed a legal line, which undermines the Constitution’s guarantee of due process of law.
The Supreme Court should overturn Dr. Ruan’s conviction and correct the Eleventh Circuit’s erroneous interpretation of the Controlled Substances Act. Doctors who sincerely believe they are practicing good medicine should not be treated like drug dealers.
Pushed to the breaking point, pharmacy technicians are quitting in waves and stores are struggling to hire, leading to shorter hours, delayed prescriptions and risky mistakes.
Heidi Strehl worked as a pharmacy technician at a Rite Aid in the Pittsburgh suburbs for more than 16 years. She loved her customers, enjoyed her job and thought of her co-workers as family. But this fall, Strehl abruptly quit, walking out in the middle of a shift — one of many in a wave of pharmacy technicians who are doing the same.
Most of the people behind pharmacy counters who count pills and fill medication bottles are pharmacy technicians, not pharmacists — low-wage workers in positions that don’t require college degrees. Working in a pharmacy was always fast-paced, Strehl said, but in recent years the workload and stress had increased to unsustainable levels, while staffing and pay failed to keep up. During the coronavirus pandemic, the pace quickened further, especially once pharmacies began giving Covid-19 vaccine shots. Her store regularly ran behind on prescriptions, often with several hundred waiting to be filled each morning.
“It got to the point that it was just such an unsafe working environment, where you are being pulled a thousand different directions at any given time,” she said. “You’re far more likely to make a mistake and far less likely to catch it.”
The last straws for her came in October. Strehl said she got an “insulting” 25-cent raise, bringing her to $15.08 an hour. A few days later, after yet another customer yelled at her over a delayed prescription, she had a panic attack in a corner of the pharmacy, crying and struggling to breathe while work continued around her. Then she grabbed her things, hugged her co-workers and walked out for the last time.
Heidi Strehl with her husband and children in 2020.Ashley Costanzo
“I always thought I would retire from that place,” Strehl said. “But all of the parts of my job that I truly enjoyed over the years had slowly just gone away.”
Strehl is one of about 420,000 pharmacy technicians in the U.S. Even though they aren’t highly paid — the median pay is $16.87 per hour — and often have no pre-employment medical training, they are vital to the health care system. They help pharmacists fill and check prescriptions and make sure patients get the right medication in the right amounts at the right time. Some even give vaccinations.
In recent months, many technicians have quit, saying they’re being asked to do too much for too little pay, increasing the possibility that they will fill prescriptions improperly.
Employers, from major drugstore chains like Rite Aid, CVS and Walgreens to mom-and-pop pharmacies and even hospitals, are struggling to replace them. It’s yet another of the labor shortages that have gripped the country this year. At many drugstores, the pharmacy staff members who remain are stretched thin. The shortage has led to dayslong waits for medication, shortened pharmacy hours and some prescription errors and vaccination mix-ups — like children receiving an adult Covid-19 vaccine shot instead of a flu shot — in a business sector in which delays and mistakes can have serious health consequences.
“Over the last five to six months, we’ve seen a spike in these conditions,” said Al Carter, the executive director of the National Association of Boards of Pharmacy, a nonprofit organization that represents state pharmacy regulators. “In some states you have 60 or 70 pharmacies that are closing for days on end, because they don’t have the appropriate staff.”
A sign outside a CVS pharmacy Dec. 2 in Indianapolis. Staff shortages and a rush of vaccination-seeking customers are squeezing drugstores around the country. That has led to frazzled workers and even temporary pharmacy closures.Tom Murphy / AP file
While the shortage of technicians is being felt throughout the pharmacy industry, Carter said retail pharmacies, which have some of the lowest-paying positions in the industry, have been hit the hardest.
NBC News spoke to 22 retail pharmacy technicians in 16 states who recently quit or were considering quitting their jobs at major retail chains. Their experiences echoed Strehl’s. Workload rose dramatically during the pandemic, but staffing levels didn’t, with many stores instead losing workers and struggling to fill positions, compounding stress and burnout. All of the technicians said patient safety was their biggest concern.
“Being consistently overworked, underpaid, stressed out and behind, there’s room for way too many mistakes,” said Bella Brandon, who left her technician position at a CVS in Ohio in July without having another job lined up because she was so concerned about the potential for a deadly medication error.
“I had to get out of there as soon as possible,” said Brandon, who now works in a hospital pharmacy with higher pay and more staff members. “It’s not my job to play God.”
Rite Aid, CVS and Walgreens all said they are proud of their staff members’ work during the pandemic and are taking steps to support them, including major hiring efforts, often with signing bonuses. Rite Aid said it was temporarily closing most pharmacies an hour early to alleviate stress and help staff members catch up on work. Walgreens said that when staffing shortages affect stores, it may temporarily adjust store hours. CVS said its teams “remain flexible in meeting patients’ needs” during the national workforce shortage.
Both Walgreens and CVS recently announced that they would increase technicians’ starting salaries to $15 an hour or more. In a statement, the National Association of Chain Drug Stores lauded the work technicians do and encouraged consumers to make vaccination appointments ahead of time to help manage workflow in busy pharmacies.
‘Not a cheeseburger’
Pharmacies can’t run without technicians, who do the lion’s share of work behind the counter, from counting pills to taking phone calls and ringing patients up. While anyone can become a technician, filling prescriptions is a complex process, more than two dozen technicians and pharmacists said. It takes months of training about drug interactions, insurance claims and more to become skilled and efficient. Many states and employers require technicians to earn certifications after a certain number of months of work, as well.
Pharmacists, who have doctorates and make six-figure salaries, check technicians’ work, consult with doctors, counsel patients and give vaccination shots. During the pandemic, many states began allowing technicians to give vaccination shots, as well, but everywhere, pharmacists and technicians said, the expectations for both jobs have been increasing.
“In an unsafe environment — because of the shortage of staff and increased workload that is being presented to that staff — your chance for error is going to increase,” Carter said. “When you’re dealing with medications, any prescription error could be life or death.”
As the pressure has mounted, mistakes have increased, technicians said. They, their pharmacists or their patients are catching more miscounts of pills, mislabeled doses, even medications packaged in the wrong person’s bag. Regulators are getting more complaints about prescription errors, as well, Carter said.
In statements, CVS, Rite Aid and Walgreens all said that patient safety is their top priority and that they have systems to ensure that prescriptions are filled safely and accurately.
NAPERVILLE, IL — The daughter of a Hong Kong man who was treated for coronavirus at Edward Hospital asserts that his recovery is due to a DuPage County judge ordering the hospital to permit him to receive ivermectin treatments.
Sun Ng, 71, was released from the hospital Nov. 27, according to a news release from Mauck & Baker, LLC, the law firm that represented the family’s case. Ng was hospitalized with coronavirus on Oct. 14 and placed on a ventilator four days later.
Ng’s daughter, Dr. Man Kwan Ng, sued Edward-Elmhurst Health after the hospital denied her request to allow her father to receive ivermectin, according to a previous news release from Dr. Ng’s lawyers.
In early November, Judge Paul Fullerton ordered the hospital to allow Dr. Alan Bain, who is not vaccinated against coronavirus, to come to the hospital to provide ivermectin treatments.
Dr. Ng said her father’s recovery “is beyond our expectations,” per a Nov. 29 news release. She said, “Our family especially thanks Judge Paul Fullerton. Without him, we couldn’t bring my father home and couldn’t see him smile at us again.”
Ng added, “We also sincerely thank Dr. Alan Bain for walking along with us and his administration of ivermectin to my father.”
Joseph Monahan, a lawyer who represents Edward Hospital, previously contended Ng had shown improvement prior to being given ivermectin. “Monahan also said the hospital was unable to confirm the contents of the drug given because the doctor obtained it online from India,” Daily Herald reported.
Ivermectin is not FDA-approved to treat coronavirus in humans. On the FDA’s website, the organization outlines potential dangers of using ivermectin.
A representative for Edward-Elmhurst Health declined to comment Tuesday, citing patient privacy regulations.
I have read of other stories, like this one… where hospital refused to give a pt Ivermectin .. .because the practitioner prescribing the med was not on staff at the particular hospital and there has been some judges that have supported a hospital right to refuse to given COVID-19 pts Ivermectin – over some hospital policy… Should we expect to see some legal action against those hospitals and/or judges if the pt died – after not being permitted to take the Ivermectin ?
Or maybe, there will be a settlement with a confidentiality agreement attached that will get buried – just like the pt that died was ?:
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
From the Prophets Hosea and Norm we learn:
“My people are destroyed
from the lack of knowledge
Because you have rejected knowledge,
I will also reject your”
“ignorance which can support irresponsibility and irresponsibility is not forgiven”
Mr. Ron Chapman II began his career as an officer in the U.S. Marine Corps and was deployed to combat in Afghanistan. He achieved the rank of Captain before transitioning to law.
He graduated from Loyola School of Law, where he received his Master of Laws (LL.M.) with a concentration in health care compliance.
BY RON CHAPMAN ESQ
SINCE WHEN DOES LAW ENFORCEMENT DICTATE MEDICAL PROCEDURES AND ESTABLISH MEDICAL PROTOCOLS?
He quickly established himself as a premier healthcare defense counsel and is among the few attorneys to have achieved trial acquittals on behalf of clients charged with healthcare financial fraud or improper opioid prescribing.
He now shares his wisdom and learned experiences in the book – Fight the Feds: Unraveling Federal Criminal Investigations. To purchase his book, please select the link below:
A PODCAST
WAR AGAINST PATIENTS IN PAIN
From Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner, Ruan v. the United States, Befoe the United States of America Supreme Court Case No. 20-1410 (May 7, 2021):
EXCERPTS
“Prosecutorial and judicial statutory reconstruction to more easily convict practitioners is not the cure for drug-related morbidity and mortality. See Centers for Disease Control and Prevention, National Center for Health Statistics, Drug Overdose Deaths in the U.S. Top 100,000 Annually (Nov. 17, 2021), https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm (reporting an almost 30% increase in and a record-high number of overdose deaths between April 2020 and 2021).
As we previously explained, and as the petitioners have described in the consolidated cases here, the Tenth and Eleventh Circuits have effectively eliminated Section 841(a)(1)’s mens rea requirements as applied to prescribers.
While the government must prove intentional or knowing distribution of controlled substances for Non-prescribers under Tenth and Eleventh Circuit precedent, the government may convict an authorized prescriber of felony distribution without proof that they had any knowledge of “all the facts that make”
FOR NOW, YOU ARE WITHIN
BENJAMIN CLEMENTINE “THE NEMESIS” 2015 LONDON ENGLAND
THE NORMS
Thank You, I ask you to donate to the Pharmacist For Healthcare Legal Defense Fund, fight the DEA attack on me & Pronto Pharmacy now Gulf Med Pharmacy our goal 100k, Appeal Court 1st Dist Wash DC. Click to Donate: http://gf.me/u/2qffp4 #GoFundMe or cash app: $docnorm or to Zelle: 3135103378
I am a middle-aged educator from the east coast. I first would like to say that I appreciate the advocacy and work you do. For quite some time, I have followed your posts and have learned a lot about how crazy (to say the least) the world of medicine, specifically pain/controlled medication has become. Sadly, as you pointed out on numerous occasions, it shouldn’t be this way.
I can guarantee that you have heard almost every scenario know to man, so this one may not be any different but I will give it a shot:
During an appointment with my psychiatrist, we discussed my ADHD, anxiety, Sleep Apnea, and Narcolepsy. The Psychiatrist knows I am prescribed a controlled med by my Pulmonologist for the Sleep Apnea/Narcolepsy and my Pulmonologist knows I am prescribed controlled med for my ADHD. Out of nowhere, my Psychiatrist berated the hell out of me for being on two low dosage controlled medications that both medical professionals know about. The Psychiatrist went on to say that I have been red-flagged by the DEA. Where the encounter gets interesting is that the Psychiatrist, is that right after this verbal onslaught, he sent my prescription to the pharmacy and said “Happy New Year, see you in 4-weeks”.
Why would he go-off on me, stating the DEA has flagged me and then submit the prescription for the controlled med to the pharmacy?
I did ask him if I could have documentation and the reasoning I was flagged by the DEA, and he said, “Because its two controlled meds that’s your documentation”. I insisted that he provide me with a law and the documentation showing that I am flagged and the reasoning, which his response was, “I will get back to you with that”. Pretty much, he thought I was unknowledgeable of the law and other such things that he has no answer because this was over a week ago now and I haven’t been given any documentation as to what I requested.
I am no expert of the law, but I have seen what I will call a “real Psychiatrist” before (unfortunately he retired a few years ago) and know that the “legal limits” these doctors say when it comes to ADHD/ADD meds are not written into law. Hell, I was prescribed a much better regerminate by the real Psychiatrist that worked but sadly no one is willing to follow what worked for me.
Anyway, if you have time to dissect this and/or have any insight, I would greatly appreciate it.
This pt seems to be yet another pt snagged in the NARXCARE OVERDOSE RISK SCORE that I made a post about earlier today.
I would guess that a pt being prescribed a controlled med(s) from two different prescribers could be a AUTOMATIC RED FLAG… According to those arbitrary rules that the DEA have developed from their observations of what substance abusers and diverters do… and it would seem that – from the DEA’s logic/perspective – if abusers do this… then anyone doing the same/similar things – must be a substance abuser or diverter.
Narxcare states that they use (AI) artificial intelligence to come to these Overdose Risk Scores.. it is too bad that they don’t use some REAL INTELLIGENCE to derive these SCORES not not one just based on some numbers and PRESUMPTIONS
