There is DEA “truth” and then there is REALITY

Posted on December 18, 2022 by Pharmaciststeve

What is the *Real* Shelf Life of Prescription Opioids?

https://www.acsh.org/news/2022/11/25/what-real-shelf-life-prescription-opioids-16692

What’s the deal with the “discard after one year” label on pill bottles? Is it based on real science? Or, is the FDA just trying to get you to send in “outdated” medicines, especially prescription opioids?

If you’re waiting for Drug Giveback Day have a comfortable chair. Image: DEA

Here’s a message from the FDA. [Emphasis mine]:

Don’t Be Tempted to Use Expired Medicines…Out with the old! Be it the fresh start of a new year or a spring cleaning, consumers are encouraged to take stock of what has surpassed its usefulness. Medicines are no exception.

This is a size-48 waist pant load of crap. It is that wrong. More on this later. 

The agency has zero credibility here, especially since it has created a monumentally dumb program where people with “excess” opioids (1) can put them in an envelope and mail them back to the FDA. What a splendid idea!  I wrote about this in 2022 and 2020:

If you want to dispose of or return your unused opioids feel free to do so, but doesn’t that seem a bit like returning the unused portion of your paycheck to your employer? “Well boss, I didn’t use all the money this month, so here’s what I didn’t need.”

Yours truly, Do We Really Need To Study How To Dispose Of Unused Opioids? Seriously? 12/20

And here’s what I envision what the return envelope might look like:

Speaking of the drugs being stolen, I got the following comment after that story from a reader who calls himself Victor Frankenstein (presumably a pseudonym, but considering all the nutlogs that follow me, I can’t be certain) after the 2022 article: Image: licensed from Shutterstock

I had mentioned this to a good friend over a couple of beers, who is also a U S Postal Service Employee. After his beer shot out of his nose, we were able to clear his airways and get a proper response. He noted that the U S Postal Workers will ensure that any of these envelopes “clearly marked” will be properly and expeditiously delivered to the proper receiving entity.
On another note: Years ago, he also informed me that a good U S Postal Service Worker can smell money in an envelope and also showed me how to remove it from the envelope without opening it. Using only a “Hair Pin”… I  have a question. Is it not illegal to send narcotics through the mail? Unless of course, it’s from China.

Victor Frankenstein in rare form, 6/22. Comment after this article

Way to go, Vic! (Notice: The monster pseudonym program is now over. I don’t want to hear from any Dick Draculas or George Godzillas.)

Time for the science

Note: I’m not encouraging anyone to take any medicine after the expiration date on the bottle. This article is merely a look at the data on drug efficacy and safety of drugs over time. You can decide for yourself what, if anything, to do with this information.

Medscape thoroughly trashes the FDA’s Mr. Rogers-like advice. [Emphasis mine]

Are Drug Expiration Dates a Myth?? Note that the FDA requirement is a date at which potency is still guaranteed. In most cases, the drug in question has not been tested for efficacy or toxicity past that date. There is also no incentive in the regulations for a pharmaceutical manufacturer to look for ways to lengthen that date of expiration.

This is a blatant case of “absence of evidence vs. evidence of absence.” The FDA checks drugs after one year and finds that they are OK. This does not mean that the agency tested them after five years and determined whether they were not OK. This is where the one-year warning comes from. It means almost nothing. We can conclude from the FDA’s limited study that the real number could be one year or 1,000 years. There is no way to tell.

Except there is

  • The Harvard Medical School reported that the military, sick and tired of regularly throwing away expensive drugs, conducted its own study:

“[T]hey found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.

  • Likewise, a 2012 study reported in JAMA Internal Medicine revealed:

Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers. All had expired 28 to 40 years prior to analysis…Twelve of the 14 drug compounds tested (86%) were present in concentrations at least 90% of the labeled amounts, the generally recognized minimum acceptable potency. Three of these compounds were present at greater than 110% of the labeled content

More specifically:

Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates

Well, would you look at that! Vicodin (hydrocodone plus acetaminophen) pills that have been sitting around in a bottle for about 30 years are just fine, yet the FDA wants you to return them. Based on zero evidence that the drug was no longer useable.

EMC Pharma makes, among other things,  OxyContin. From its product sheet:

Likewise, the shelf-life of Dilaudid (hydromorphone) is given as three years but is probably longer, maybe by a lot. 

In a more extensive study, the drug giant Sandoz analyzed 122 drugs and found that 88% of them were safe to use more than 5.5 years after the expiration date. Some of these included:

  • Morphine sulfate (solution): 89 months (> 7 years)
  • Fentanyl citrate (solution): 84 months
  • Diphenhydramine (Benadryl): 76 months
  • Naltrexone hydrochloride (solution): 77 months
  • Ketamine: 64 months

Some Generalities

  • Almost all solid (tablet or capsule) drugs are stable past their expiration dates.
  • Solutions are less stable than solids but may still be OK if stored properly.
  • This does not hold true for most antibiotics, especially tetracycline, which forms a toxic isomer even when inside a capsule. Don’t use expired antibiotics. Bad idea.
  • Storage conditions matter. The enemies of drugs are light, heat, oxygen, and moisture. If you keep them sealed, in the dark (maybe even cold), the opioids I showed above will be useable for many years. 
  • But keep in mind that the FDA tells you the opposite.

What to do? 

My personal opinion is based on the chemical structures of a given drug and is reinforced by the studies above. I think you have to be absolutely out of your mind to return expired opioid pills because there’s an excellent chance you won’t get them back when you really need them. Don’t just take my word for it. 

Should you be unfortunate enough to walk into the ER at Maimonides Medical Center in Brooklyn with a kidney stone, you’ll run into this mentality: [Emphasis mine]

Relying on opioids as the primary analgesics for moderate to severe pain is inadequate, unsafe, and costly…I am just trying to come up with a feasible, practical solution or alternative to opioid analgesia in the emergency department… For now, it is an alternative, but who knows what may happen later on. Perhaps we will be able to eliminate opioids altogether, which would be fantastic. 

– Sergey Motov, MD, Maimonides Medical Center

All of you can make up your minds, but I think I’ll hang on to my small stash of 5-year-old Percocet. Ya never know when you might run into trouble, let’s say, in Brooklyn.

NOTE:

(1) The term “excess opioids” is right up there with a Model-T Ford. You are unlikely to own either of them.

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If you think health care is dysfunctional now, just wait until after January 1

Posted on December 17, 2022 by Pharmaciststeve

If you think health care is dysfunctional now, just wait until after January 1

https://www.statnews.com/2022/12/08/health-care-even-more-dysfunctional-after-medicare-cuts/

Doctors across the country, especially those in primary care, have been up in arms about Medicare’s proposed cuts in reimbursement that are scheduled to go into effect on January 1. They are concerned — rightfully so — that these cuts will be ruinous to their practices and compromise the care they can provide to their patients.

As an emergency physician, I worry about the cuts for a different reason: emergency departments might soon be filled with more and more people who can’t access primary care.

In a recent commentary in the Washington Post, Shirlene Obuobi, a physician in Chicago, wrote about why patients no longer feel cared for by their physicians. Among other things, she described how Medicare and private insurers “reward procedures, imaging, tests and other diagnostics that generate revenue and have high reimbursement rates.”

Falling payments to primary care doctors and generalists have forced them to increase the number of patients they see in a day, sometimes having to schedule patients every 10 minutes to justify staying open. The inevitable burnout caused by such pressures will likely drive some away from primary care, making that kind of essential care even harder to come by.

Related: Physicians rally to avert Medicare payment cuts

I see the consequences of this system nearly every time I work in the emergency department: the patient with headaches who has had to wait six months for a neurology appointment, the uninsured patient with newly diagnosed diabetes, or even the patient who delayed a routine mammogram and now has cancer.

The U.S. health care system is broken and Obuobi is right to call attention to it. But as bad as things are now, they’re going to get worse if the proposed Medicare reimbursement cuts go into effect, because even more people will find themselves unable to access primary care.

As an emergency medicine doctor, I’m trained to take care of people with heart attacks, strokes, gunshot wounds, appendicitis, broken limbs, and other time-sensitive emergencies that need prompt recognition and treatment. Yet I find myself increasingly having to address problems that would better be served by a primary care physician, things like routine management of diabetes and high blood pressure.

I like to think I’m a good doctor, but I’m not the one you want adjusting your blood pressure medicine or instructing you how to dose your insulin at home, especially not after you’ve waited six hours while I was treating people with more acute and life-threatening issues. I can’t bring you back for an appointment in two weeks to see how things are going, and I can’t be available by phone if you’re not getting better. I can’t follow your progress over time and make the adjustments that keep you healthy. It’s not what I’m trained to do, and any attempt I would make would fall woefully short of what a primary care physician can do.

It’s a shame that primary care physicians are so undervalued by the U.S. health care system’s reimbursement structure, because the work they do is so important. More than any other physicians, they are tasked with keeping us healthy. I focus on treating decompensated disease; primary care doctors spend a lot of their time working to ensure their patients never get the disease in the first place and, if they do, it is well controlled. In addition to being important for patients, this work is also incredibly cost-effective. Ensuring that a patient with diabetes is controlling their blood sugar is far less expensive than having that patient be rushed to an emergency department in a diabetic coma.

Related: Empower primary care with adequate payments and technology

I realize that physicians complaining about pay might not generate much sympathy from the public. But please hear me out. Many primary care physicians are in private practice, meaning they’re responsible for their own overhead. Medicare physician reimbursements are set to be cut by approximately 4% on January 1. When factored in with other projected Medicare cuts, the total cuts physicians can expect to see are closer to 8.5%. And that’s not even accounting for inflation. If reimbursements fall that dramatically, these physicians may have no choice but to stop accepting Medicare patients in order to keep their lights on. And given that most insurance companies set their reimbursement rates based on Medicare’s, it’s reasonable to expect that reimbursement will fall across the board, meaning that primary care doctors may be forced to accept only patients who can pay out-of-pocket.

The downstream effects of Medicare’s cuts would be devastating. People who are shut out of primary care will increasingly turn to emergency departments to meet their needs, needs these departments and their practitioners were never designed to meet. This January and beyond, in the middle of Covid-19 and flu season and the rise in RSV infections, the last thing hospitals need is more people crowding emergency departments. Yet that is exactly what will happen if the reimbursement cuts go into effect.

There is still time to act. Congress has the power to avert these pay cuts and there is currently a bill in the U.S. House of Representatives, the Supporting Medicare Providers Act of 2022 (H.R. 8800), aimed at doing just that. Yet the clock is ticking and, with under a month before the new year, I am rapidly losing hope that these cuts can be avoided.

Even if Americans don’t like to admit it, health care is a business and businesses need to be adequately paid so they can continue to offer their services. Ringing in the new year by slashing Medicare payments will hit primary care physicians the hardest, but it will be disastrous for the entire health care system. My colleagues and I in emergency departments across the country will be forced to try and fill the void, and we will do our absolute best to do that. But people would be much better served by readily available primary care, a business that should be rewarded for the important work it does to keep people healthy and out of emergency departments and hospitals.

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Is the curtain being pulled back on our federal judicial shenanigans ?

Posted on December 17, 2022 by Pharmaciststeve
2022 may go down in history as many of the shenanigans of those within our judicial/politicians at the federal level  comes out of the shadows and into the daylight and perhaps even under a microscope.  As outlined in this article the federal prosecutor had gathered a number of Dr Pompy’s current & former employees and a number of pts that the prosecutor believed would testify on how poorly Dr. Pompy practiced medicine. 
Apparently prosecuting witness after witness testified how Dr Pompy was doing everything “by the book”.  What did the prosecuting attorney promise all these witnesses ?  Immunity from being prosecuted themselves for being “active participants” in the alleged “pill mill” that Dr. Pompy was running.
Over the years, I have read where the DEA would find pts within a practitioner’s office that doesn’t have a “clean rap sheet” and would convince these people that if they testified that the targeted practitioner was doing exactly what the DEA wants them to testify to, in exchange for a “get out of jail card”
Obviously, these prosecutor’s witnesses if they tell the truth and Dr. Pompy is found NOT GUILTY… they have not risk of being charged or jailed for helping Dr. :Pompy prescribing controlled substances “too loosely” and without “valid medical necessity “
It may only be a matter of time that state and federal bureaucrats step up and pay attention to how far off the rails some parts of the various agencies have strayed.  People in under/untreated pain can be ignored, because there is no real lab test that will determine the intensity of the pt’s pain.  Suicides from under/untreated pain should not be ignored.  I don’t encourage or condone suicide, BUT… should pts leave behind suicide videos and/or suicides notes and should the pt’s family or friends share this with the local prosecutor to press charges against practitioners that have ignored the pt’s routine sharing what the intensity of their pain really is.  Should pts who have extremely high blood pressure due to their under/untreated pain continue to ask the practitioner why they are allowing their BP to stay in a hypertensive crisis level of the physical damage (eye & kidneys) or stroke or heart attack the pt is at risk of.
Likewise, should pts continue to remind their practitioner of the liver & kidney & GI bleeds from routinely taking Acetaminophen ( Tylenol ) & NSAIDS ( Motrin/Aleve)… they claim that 15,000/yr deaths associated with the use/abuse of NSAIDS.  The number of liver failures caused by the use/abuse apparently is not really track or the numbers are not disclosed

 

THIS WEEK’S ASSESSMENT IN THE FEDERAL TRIAL OF LESLY POMPY, MD.: ” DR. POMPY IS THE TRUTH,” WITNESS FLIP ON AUSA PRATT AS HE APPEARS DESHUFFLED

You’re Within The Norms

“Doctor Pompy is the Truth“

THE TESTIMONY OF PROSECUTION WITNESS DIANA KNIGHT

Throughout this week, Prosecution witness after witness flipped in their testimony on the stand in support of Lesly Pompy MD as AUSA Wayne Pratt grew angry and outright attempted to manipulate the testimony of his own witnesses.

This came after Diana Knight, a witness for the prosecution, stated, “proper billing occurred and that nothing was fraudulent.” Ms. Diana Knight was Dr. Pompy’s medical office biller and her testimony was strongly in Pompy’s favor. She further addressed the EMR-coded visits.

“Blue Cross acknowledged that time is not of the Essence for billing unless more than 50% of the visit Time was spent on counseling or coordination of care.” 

The Prosecution grew visibly angry and lashed out as Ms. Knight was asked (by the prosecutor), “whose side are you on, the truth or Pompy’s?” Stoically, holding her composer, and with resolve in her voice, she said:

“I am on the side of Dr. Pompy because Dr. Pompy is the truth.”

As reported earlier Diana Knight maintained her composure during intense, relentless attacks by prosecutors She won the jury’s heart literally. Ms. Knight writes:

“I am beyond proud of Dr. Lesly Pompy’s legal team. They are doing an amazing job for all of us, .standing up for our rights.I have smiled, I have cried, and I have felt overwhelmed during this trial, but most importantly, I have felt grateful. They are truly a blessing right now. I could never thank them enough for all they are doing.”

Prosecution ARRAY OF fumbling Witnesses

One former employee Abby Higgins turned against Dr. Pompy. She had worked for Pompy years earlier while in high school. After graduation, she went on to nursing school (never worked for Pompy in a nursing capacity) but hadn’t worked for Dr. Pompy since leaving high school nearly 12 years ago.

Ms. Higgins claimed that the visits, when she had worked for Pompy as a high school student, were, “too fast.” Abby Higgins’s testimony was impeached thoroughly after it was revealed that her aunt worked at the  Detroit US Attorney’s Office. 

PROSECUTION DROPS FIVE CHARGES

The lack of evidence was so severe that even the prosecution medical expert (smcs), Dr. Christensen, stated that these counts should be dropped. * 

Dropped were Counts 26, 30, and 31,34,39. Pompey’s medical expert witness Dr. Murphy testified that :

1) our patients had real problems;

2) our patients were billed appropriately;

3) Dr. Pompy acted like a doctor; 4) no drug dealing occurred;   5) our patients received medications most likely to help them. 

Prosecutor Wayne Pratt’s cross-examination of Dr. Murphy and Pompy’s Medicare Expert appeared reshuffled and confusing.

 

https://www.facebook.com/groups/DontPunishPainRally/permalink/2410176615802566/?mibextid=W9rl1R

 

SUPPORT FOR DR LESLY POMPY

Diane Greer:

“It’s horrible what they did to this good man!! May the ones who participated in his persecution get the same in return for their evil behavior!!”

Diana Knight:

“I really miss Dr. Pompy. Not for my pain management but as a physician in general. He always found my problem and helped to correct it, or at least an answer to it.

I miss the days when he’d sit down and discuss your labs and such while the entire time critically thinking of what to do about it. Then dig deeper if needed. He always saw me as a whole picture, not just arm pain. Just wanted it put out there.”

Pamela Hoard:

To: Michael Ney, MD.

“On and on it goes. There is an assembly line of fake patients and another of unlawfully arrested doctors, in my opinion. I worked for four years with the detectives of a police dept in a large county. I pick up a few things and don’t know it all. Then there’s an assembly line coming with bedridden patients in sheer agony.

These assembly lines come out of the DEA factory with judges overseeing everything. Thank you, Michael, for keeping us alert and educated about these trials. When I was a Federal Court expert witness for six judges for three years on drug-related cases I also got an education on judicial practices.

Michael, you are a valuable person in the Chronic pain community. Your work is appreciated.”

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Law Enforcement’s Achilles heel : House Passes New Bill To Abolish Qualified Immunity for all local, state, and federal law enforcement officers

Posted on December 16, 2022 by Pharmaciststeve

Law Enforcement’s Achilles heel : House Passes New Bill To Abolish Qualified Immunity for all local, state, and federal law enforcement officers

On a largely party-line vote, the U.S. House of Representatives on Wednesday night approved the George Floyd Justice in Policing Act (H.R. 1280), a massive overhaul of American policing that would make it much easier to sue rogue officers. Among its many provisions, the bill would eliminate “qualified immunity” for all local, state, and federal law enforcement officers. Under qualified immunity, government officials escape any legal liability for civil rights violations unless the victim can show that their rights were “clearly established” at the time.

Thanks to this loophole, federal courts have upheld qualified immunity to Fresno officers accused of stealing more than $225,000 in cash and rare coins, an Idaho SWAT team that bombarded an innocent mom’s home with tear gas grenades, and a Georgia sheriff’s deputy who accidentally shot a 10-year-old boy while aiming for the family’s dog. 

“We as a country have a choice: We can either choose police accountability, or choose qualified immunity, but we cannot choose both,” one of the act’s original cosponsors, Congressman Ritchie Torres (D-NY), said on the House floor. “The purpose of the George Floyd Justice in Policing Act is not to second guess officers who act in good faith, the objective is to hold liable officers who repeatedly abuse their power and who rarely, if ever, face consequences for their repeat abuses.”

A nearly identical version of the bill passed the House last summer but never got a floor vote in the Senate. Though the Justice in Policing Act still faces an uphill battle this session, prospects are brighter. Ending qualified immunity is backed by around two-thirds of Americans, including many prominent celebrities like Tom Brady and the co-founders of Ben & Jerry’s.

While this only passed the House during the current Congressional session …BUT… a new Congressional session starts in a few weeks.  It was just reported today that another patient ( Jessica Fujimaki ) died from losing their pain management resulting from the DEA’s raiding Dr. Bockoff office last month. Not from suicide because their pain meds were eliminated… BUT… from WITHDRAWAL and fatal complication of her existing diseases.
More police – especially locally – are being taken to trial and found guilty for harming/killing people that were otherwise innocent. George Floyd’s death was seemingly the trigger of a lot of social/civil unrest, followed by Breonna Taylor death in Louisville, KY over a no-knock warrant – at the wrong house.
We all know that the vast majority of cops – especially at the state level –  are pretty good/honest people.
Unfortunately, we cannot say the same for those who are part of our Federal Judicial system.  Just read in the blog link below, towards the end of the text. How much – or little – the DEA did to help all those pts of Dr. Bickoff when they raided/closed his office and threw all those pt to the curb.

This Couple Died by Suicide After the DEA Shut Down Their Pain Doctor

There is already THREE DEATHS directly/indirectly related to the DEA’s raid of Dr. Bickoff’s office… most likely, there will be more.

It seems really hard to tell who is sleeping with who

U.S. opioid crackdown hampers some patients’ access to all controlled substance Rxs

I always thought that it would take some sort of legal activity to protect the community. I never considered revoking law enforcement’s “qualified immunity”  but The House Representative Rep Karen Bass (D) is now mayor of Los Angles to replace the mayor that got recalled.

However, the community has a bill already written to try and get passed by both Houses of Congress in the next 2 yr session that starts in Jan.

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IN THE TRIAL OF LESLY POMPY MD: PROSECUTION REST!!! “TESTIMONY OF DETECTIVE MARC MOORE “MICHIGAN BLUE CROSS FABRICATED CASE AND TARGETED DR. POMPY”

Posted on December 15, 2022 by Pharmaciststeve

Http://www.youarewithinthenorms.com
IN THE TRIAL OF LESLY POMPY MD: PROSECUTION REST!!! “TESTIMONY OF DETECTIVE MARC MOORE “MICHIGAN BLUE CROSS FABRICATED CASE AND TARGETED DR. POMPY”

You’re Within The Norms

Dec 15

REPORTED BY

youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., 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

LESLY POMPY MD

NOTES FROM TRIAL IN FEDERAL COURT DETROIT MICHIGAN

(notes may not reflect the actual date of testimony, only the date received)

December 14

Marc Moore Testified:

Marc Moore conceded that he had no medical training, and no billing and coding knowledge. Marc Moore lacks the education, training, or experience to issue a legal opinion as to the illegal distribution of controlled substances, or insurance fraud.

My attorney played the tape of Marc Moore mocking my education. Marc Moore testified that he was keeping his cell phone on 9/26/16 so that he would see all of the drug addicts texting him to buy drugs.

The government seized my cell phone, text messages, and emails. The prosecutor can not show that any person or animal, texted/called/emailed me asking to buy drugs. The government case now rests.

My medical expert witness, Dr. Murphy ( no relationship to Judge Murphy, of the case), began to testify. He showed how the undercover from the Blue Cross Blue Shield, fabricated medical records obtained from Dr. Robertson. Marc Moore denied he participated in the fabrication of medical records for Blue Cross Blue Shield of Michigan Mutual Insurance Company, James Stewart, aka James Howell.

December 12

Brian Bishop was the DEA agent who was actually present at the raid on 9/26/16. Bishop will not testify. Michelle Cooper of the Diversion Department of the DEA testified that the DEA helped doctors but did not do that for “Dr. Pompy.”

1)They could have helped with record-keeping ideas, but the DEA did not.

2)The DEA performed no investigation prior to the 9/26/16 raid. I was not on their radar.

3)The DEA did not check whether the number of Suboxone patients was correct, above, or below. She agreed that going over the limit of the Suboxone patients was not a criminal offense.

4)After the raid, the DEA reduced my Suboxone patients from 275 back down to 100.

5)Diversion investigator Michelle Cooper had no idea why my Suboxone limit was dropped, after the raid.

6)Chapman found it strange that the drop occurred after the raid.

7) The jury was fascinated by prosecution witness Diana Knight’s testimony: proper billing occurred and nothing was fraudulent. Diana was Dr. Pompy’s medical office biller. She maintained composure during intense, relentless attacks by AUSA Wayne F. Pratt. She won the jury’s heart.

December 8

Good day

Brent Cathey of Monroe City Police, now Police Captain after the 9/26/16 raid, saw what appeared to be medication bottles, with an expired date, at the house. Brent Cathey did not know what was in the bottles. The bottles were not chemically tested.

Tracey Lapalme, a former addiction patient testified that Dr. Pompy made her an addict. She was surprised to find out that Dr. Pompy had her on Suboxone, from the first visit, to treat any medication misuse she may have had. Suboxone can treat pain and substance misuse.

Stephanie Stine testified that her boyfriend, Scott Jones, would beat her up, and take half of her medications. She did not report either the abuse or the taking of her medications by Scott Jones to Dr. Pompy. She testified that she had interstitial cystitis ( an incurable, painful disease of the bladder that causes pelvic and abdominal pain ), and endometriosis since she was 15. She is still on medications.
The New DEA Standard

According to Michael Dowel Esq:

“After Ruan, for the DEA to criminally convict physicians for improper prescribing under the CSA, the DEA must

(1) prove beyond a reasonable doubt that a physician knowingly or intentionally dispensed or distributed a controlled substance and that the dispensing or distributing was not authorized and

(2) prove beyond a reasonable doubt that the physician-dispensed or distributed controlled substances and knew that in dispensing or distributing the controlled substance in question, they were not authorized to do so.

DEA prosecutors may continue to utilize circumstantial evidence to prove a medical professional’s subjective intent in controlled substances cases, such as quantities prescribed, patient characteristics, examination time, medical records (or lack thereof), medical necessity, adherence to distributor agreements, the disregard of patient “red flags,” and the prescriber’s financial practices; however, Ruan places the burden of proof on the DEA to establish that the defendant’s prescribing practices fell short of professional standards and the defendant intended to prescribe without any legitimate medical purpose.”

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Biden administration proposes crackdown on scam Medicare Advantage ads

Posted on December 15, 2022 by Pharmaciststeve

Biden administration proposes crackdown on scam Medicare ads

https://apnews.com/article/health-medicare-government-and-politics-19ce28f3a5919d27cbff3dcb6d19c6e7

WASHINGTON (AP) — The Biden administration on Wednesday proposed a ban on misleading ads for Medicare Advantage plans that have targeted older Americans and, in some cases, convinced them to sign up for plans that don’t cover their doctors or prescriptions.

The rule, proposed by the Centers for Medicare and Medicaid Services, would ban ads that market Medicare Advantage plans with confusing words, imagery or logos. The new regulation would also prohibit ads that don’t specifically mention a health insurance plan by name.

It’s an aggressive step to tackle a growing problem in the Medicare Advantage marketplace, a booming business that offers privately run versions of the government’s Medicare program for people who are 65 and older or have disabilities. Nearly half of all Medicare enrollees — about 28 million — are now turning to Medicare Advantage plans.

And some have been deceived by television commercials, online ads and mailers put out by the marketing agencies and brokers that some insurers have hired to win over customers.

The proposed rule “takes important steps to hold Medicare Advantage plans accountable for providing high quality coverage and care to enrollees,” said agency Administrator Chiquita Brooks-LaSure in a statement.

The problem has become so pervasive that CMS agents have been secretly shopping for plans by calling the phone numbers in advertisements, finding in some cases that brokers have overstated the benefits that enrollees would get and the money they would save in the new plans. Democrats on the Senate Finance Committee released an investigative report last month showing that several states also reported an increase in complaints about deceptive marketing schemes in 2021.

The committee’s investigation found that older adults in Ohio, for example, were sent mailers resembling federal government tax forms promising bigger Social Security checks if they enrolled in a new Medicare Advantage plan. Nationwide TV commercials featuring celebrities have also misled some customers by telling viewers they’ll get “money back to your Social Security check” but fail to mention that the plans they’re selling vary by ZIP code or don’t cover all providers.

“These proposals are an important step towards protecting seniors in Medicare from scammers and unscrupulous insurance companies and brokers,” the committee chairman, Sen. Ron Wyden, D-Ore., said in a statement on Wednesday.

The federal agency on Wednesday also proposed regulations that would establish new wait-time standards for mental health providers that are in-network for Medicare Advantage plans. The standards would recommend that enrollees be able to access mental health care appointments within 10 days.

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If don’t like waiting in line for your Rxs… if you are a CVS pt… have they got a surprise for you starting next year

Posted on December 14, 2022 by Pharmaciststeve

I saw your post with the remote CVS work job…. here’s what I have to say. I didn’t want to post it publicly:
You know how they prepared? They launched the “Access Store” function with absolutely no standards (no one required to help anyone in particular) and THEN a week later (this past Monday) we got calls at ALL the high volume stores that all RPh overlap is being diminished/removed come 2023. So it really doesn’t matter. QP still rises, there’s no extra bodies to answer the phone. We have no idea how to navigate this. I cried when I had to make my new schedule because the loss of hours squashed my work/life balance even more. Less days off or work more 14 hour shifts to have a day of freedom. And the quality of life at work still seems to get worse😔😭

See the source image

If your are looking for a new pharmacy…. try a independent pharmacy where you will be dealing with the Pharmacist/owner  here is a link to find one by zip code

https://ncpa.org/pharmacy-locator

 

 

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It seems really hard to tell who is sleeping with who

Posted on December 14, 2022 by Pharmaciststeve

Perhaps Congress is part of this long game. In 2000, Congress passed the Decade of Pain Law… where practitioners were ENCOURAGED to treat pain. The Joint Commission came up with the “Fifth Vital Sign” and made it a MAJOR STANDARD for hospitals and others credentialed by the JC to meet. When the bill expired, it was not renewed and the Party that was in the majority when it was  initially passed was not in the majority when it could have been renewed.  I think that there was a fair amount of careless prescribing C-III opiates and probably a large amount of careless refilling of those same Rxs.

If the insurance companies helped the DEA, I have always thought it was strange that Congress has been claiming that they want to get prescription prices down and Congress has been going after the Pharmaceutical industry when it is common knowledge that the PBM industry gets untold number of tens or hundreds of millions of dollars from kickback/discount/rebates for meds the PBM pays for from individual pharmas.  Currently the top 5 PBM’s are owned by INSURANCE COMPANIES.  A lot of bilateral “back scratching” between DEA/Congress/insurance companies ?

How many of the Federal judges are in lock-step with the DEA ?  The J&J lawsuit being sued by numerous cities/counties/states, etc for being a public nuisance for being the wholesaler of raw opiate powder to the pharma industry.  The Federal Judge determined that the case was going to be a BENCH TRIAL… the Judge was going to be Judge, jury and executioner. Totally unexpectedly J&J was found guilty and fined 572 million dollars.

Recently Walgreen, CVS, Walmart settled a lawsuit over them being guilty of contributing to the opiate crisis for just 13 billion dollars

A federal judge in August ruled CVS, Walgreens and Walmart must pay a combined $650.6 million to two Ohio counties for damages related to the opioid crisis.

Teva Pharmaceutical Industries in July announced a $4.35 billion proposed nationwide settlement

Purdue Pharma and the Sackler families in March announced a settlement with a group of states that would require the Sacklers to pay out as much as $6 billion

Kroger $85 million settlement of all opioid litigation claims with the State of New Mexico.  Kroger has two active matters pending in West Virginia and Texas scheduled for trial in 2023 and 2024, respectively.

Judicial system: When the facts don’t support the charges… you just fabricate the facts ?

Pieces of the puzzle on how the DEA really functions

There was a recent prescriber being in federal court and the federal judge rejected the defendant’s 12 experts lined up to testify for him… and the defense was not told until a day or two before the trial. The only “expert” that was allowed to testify in this trial was hired by the prosecutor and was known as a frequently used – well paid – expert for the government and reportedly has no real expertise in pain management.

MARC MOORE: THE DIRTY COP OF MANTIS, IN THE TRIAL OF LESLY POMPY, MD. (MICHIGAN)  this trial is, which currently going on…it has been reported that the Judge will  not consider the recent SCOTUS Ruan/Kahn (9-0 vote) which basically told the DEA that they could not objective criteria in judging a prescriber in treating a pt for subjective diseases.

I have heard numerous attorneys state that when someone is taken to federal court … 90%+ are found guilty. maybe this is why all these corporations just PAY UP.  Odds are they are going to be found guilty and by agreeing to PAY UP while stating that the company while not admitting to any wrong doing.

Does this suggest that all three branches of our Federal Gov and many states and their various bureaucracies are all in lock-step with the DEA’S 50 y/o agenda ?  Where else, but American, can companies and entities be sued/fined for selling a LEGAL PRODUCT ?

The DEA’s Long Game

https://www.daily-remedy.com/the-deas-long-game/

The canary in the coal mine is a metaphor alluding to the initial sign of an impending calamity.

An apt metaphor for what just transpired. Recently, the Drug Enforcement Agency (DEA) issued a public safety alert informing the public about a, “sharp increase in fake prescription pills containing Fentanyl and Meth[amphetamines]”.

The alert was the canary in the coal mine, but the impending calamity is not what we are led to believe. We knew of a rise in counterfeit prescription pills for many years. It was a rise induced directly by DEA policies inflicted upon patients.

The impending calamity is not the risks counterfeit pills pose to the public, but the legal liability the DEA faces for its failed policies.

For years, federal agencies and physician advocacy groups remained in lockstep on the causes of the opioid epidemic. Lax prescription guidelines, over prescribing by willing physicians, and the addictive nature of opioids – we heard it all.

Unfortunately, these purported causes proved erroneous at best or deliberately misrepresented at worst. And implementation of policies based on these purported causes led to a rise in suicide and clinical stigmatization among chronic pain patients and patients with substance use dependencies.

This is an atrocity the DEA bears direct responsibility for.

The DEA orchestrated a culture of fear that can be described as medical McCarthyism, in which the fear of prosecution defined the quality of care for stigmatized patients. Accusations formed the basis of convictions as we saw physicians imprisoned for providing care and patients abruptly abandoned without legal recourse.

That is until now.

The American Medical Association (AMA) recently issued a report through its newly formed Substance Use and Pain Care Task Force recommending significant policy changes it believes would more effectively address the nation’s opioid epidemic. Stopping short of outright criticizing the DEA, the report proposes policy recommendations that diametrically oppose the DEA’s approach to the epidemic.

The report is simply the latest in a long line of published studies casting doubt on long held assumptions about the opioid epidemic. We know there is no correlation between opioid-related mortality and the number of opioid prescriptions. We know abruptly discontinuing opioids leads to adverse patient outcomes. And we know forcing physicians to reduce the number of opioid prescriptions leads to a rise in counterfeit prescription opioids.

All of which makes the public health alert by the DEA even more curious.

It is absurd to believe the DEA is not aware of the clinical consequences of its failed policies. And to issue a public health alert without acknowledging the basis for such an alert is deliberately deceptive – disrespecting the lives of patients lost through these policies and conveying a lack of accountability on the part of the DEA.

But lacking accountability is different from lacking awareness. The DEA is clearly aware that its aggressive approach to criminalizing the patient encounter has led to a rise in counterfeit prescription medications and adverse patient outcomes.

In Kentucky, a federal judge deemed a pain management practice liable for the suicide of a patient unable to receive adequate pain relief, who then committed suicide as a result of the untreated pain. The judge ruled that the physicians were liable for the suicide because they inappropriately reduced the patient’s opioid prescription dosage.

A ruling that implies patients have a right to be treated for pain, which when applied broadly to all chronic pain patients would hold the DEA liable for undue harms caused to patients based on its aggressive stance on opioid prescriptions.

Something the DEA is well aware of, but seems bent on assuming no accountability for, hoping the failed policies are seen as well-intentioned errors.

But in recently uncovered reports obtained through multiple FOIA (Freedom of Information Act) requests, it appears the DEA’s aggressive stance extends beyond erroneous policies and the unintended specter of clinical fear – to something far more nefarious, far more deliberate.

For years the DEA colluded with major insurance companies to obtain data on prescribing practices for physicians who treated patients in pain with prescription opioids, contracting covert, third-party data-mining companies to troll medical records without the consent of patients or the knowledge of physicians.

In 2016, these data-mining companies modified the data analysis, changing the definition of a high risk opioid prescriber to encompass a majority of physicians who prescribed opioids. The adjustment was a blatant attempt to coordinate and expedite the indictment of physicians, and to strengthen the likelihood of convictions.

It should come as no surprise that this is when we began to see a rise in physician imprisonments and a rise in counterfeit opioids. Both of which are a direct consequence of deliberately misrepresenting the trolled medical data.

Now, years later, lacking the support of physician advocacy groups, or the protection of public perception, the DEA finds itself confronting the ugly reality of its failed policies – and the ensuing liability.

But liability comes in different forms. Liability can be characterized as a harmless mistake or as a deliberate misrepresentation. The behavior of the DEA elucidated through the FOIA documents would suggest the latter.

Yet the public health alert provides a convenient rebuttal. A plausible excuse for the DEA to claim its failed policies were an honest mistake. The DEA can now say that when it realized its policies were leading to a rise in counterfeit opioid prescriptions, it issued a public health alert, suggesting the adverse clinical outcomes – the suicides and stigmatizations – were nothing more than an unintended consequence, an honest mistake.

For the DEA to issue a public health alert for a crisis that began years ago through its own policies is certainly a curious course of action – something we rarely see from federal agencies.

But a broader analysis reveals that the timing of the alert is less curious and more strategic. A canary in the coal mine – for the impending liability the DEA will soon face.

 

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Kroger: announced that we are terminating our Express Scripts agreement for commercial customers as of December 31

Posted on December 13, 2022 by Pharmaciststeve

Apparently Express Scripts new business model is to reimburse pharmacy for filling prescriptions less than the cost of buying the medication from the wholesaler.  Express Scripts just signed a contract with DOD for Tricare and it has been reported that abt 15,000 pharmacies – mostly independents – decided not to sign the contract they were offered because offered reimbursement was less than the cost of purchasing the medication from the wholesaler. Express Scripts is owned by the insurance company Cigna

Kroger operates under 22 different names and 3242 total stores and 2,200 pharmacy depts.  It would appear that of the 15,000 pharmacies not signing the new Express Scripts/Tricare contract may or may not include the 2,200 Kroger pharmacies.  Tricare is the health insurance for our military and veterans.

Previously, Express Scripts has been the labeled as largest PBM in the USA

https://www.fool.com/earnings/call-transcripts/2022/12/01/kroger-kr-q3-2022-earnings-call-transcript/

Kroger Health had another successful quarter, delivering higher-than-expected sales and profitability despite cycling the impact of higher COVID vaccine revenue from a year ago. We continue to see significant growth opportunities in healthcare, and our Kroger Health team remains committed to ensuring our customers obtain medically necessary prescriptions. Recently, we announced that we are terminating our Express Scripts agreement for commercial customers as of December 31. The Express Scripts contract would have required Kroger to fill our customers’ prescriptions below our cost of operation, something we could not accept as we aim to keep our prices low for customers during this inflationary period.

We expect this contract termination will reduce sales by about $100 million in Kroger’s fiscal fourth quarter, impacting identical sales without fuel for the quarter by approximately 35 basis points. This decision is not expected to have an impact on operating profit or EPS. Included in our results for the quarter is an $85 million pre-tax charge related to the settlement of all opioid litigation claims with the State of New Mexico. This amount was excluded from our adjusted FIFO operating profit and adjusted EPS results to reflect the unique and nonrecurring nature of the charge.

This settlement is not an admission of wrongdoing or liability by Kroger, and we will continue to vigorously defend against other claims and lawsuits related to opioids. This settlement is based on a unique set of circumstances and facts related to New Mexico, and Kroger does not believe that the settlement amount or any other terms of our agreement with New Mexico can or should be extrapolated to any other opioid-related cases pending against Kroger. It is our view that this settlement is not a reliable proxy for the outcome of any other cases or the overall level of Kroger’s exposure. Currently, Kroger has two active matters pending in West Virginia and Texas scheduled for trial in 2023 and 2024, respectively.

Kroger continues to believe that the claims are without merit, and that it has strong defenses to these claims. Kroger is also differently situated from many of the other defendants in these cases. Our pharmacy operations have a much smaller footprint, both in terms of the size of the business, and market share with respect to opioids, and we are proud of the outstanding work performed by our associates in delivering critical care and services to our pharmacy customers. Turning now to alternative profit businesses, which are a fast-growing and key part of our value creation model.

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Physical and Occupational Therapy Are on the Medicare Chopping Block

Posted on December 12, 2022 by Pharmaciststeve

Physical and Occupational Therapy Are on the Medicare Chopping Block

https://www.medpagetoday.com/opinion/second-opinions/102198

Cuts could be devastating to patient care if Congress doesn’t take action

Americans expect the best care from their doctors. Decades of experience, thoughtful interdisciplinary planning, and evidence-based research mean providers are treating them based on widely accepted standards of care.

For example, someone who has experienced a heart attack would never be discharged from a hospital without being prescribed medications to mitigate future cardiac events. A patient with acute pulmonary issues would receive medications and resources for oxygen therapy, if appropriate. Stroke patients receive the acute hospital-based care they need to save their lives, as well as a constellation of other types of care and services to decrease complications and enhance recovery — pharmacological, dietary, and rehabilitative.

Physical therapy and occupational therapy are among the critical standards of care that would be included for all of these patients. These services help form the bedrock of ensuring good outcomes, decreasing secondary injury and complications, and reducing rehospitalizations.

In addition to serving as an important part of post-acute care, physical and occupational therapy provided by licensed therapists can help improve balance and mobility, improve cardiovascular function, reduce pain, and decrease falls. In fact, healthcare associated with falls costs the healthcare system tens of billions of dollars each year — and exercise interventions by physical therapists have helped to lower the risk of falls by 31%.

Eliminating or reducing access to physical and occupational therapy due to Medicare cuts would be devastating to patients’ health outcomes. Not only would it undermine the standards of care for many conditions, it would also complicate the lives and tenuous health situations of the millions of Americans who depend upon it.

Seniors nationwide, therefore, are extremely concerned about the 4.5% cut to their therapy providers in 2023 under the Medicare Physician Fee Schedule. If this cut is implemented, the physical and occupational therapy community will experience cuts totaling approximately 9% by 2024. The continued practice of annual Medicare cuts threatens the sustainability of the country’s physical and occupational providers, especially in rural and underserved areas where they are needed most.

Our nation’s Medicare beneficiaries understand how integral physical and occupational therapy are to standards of care — and they value it deeply. According to a recent survey, 9 out of 10 Americans over the age of 65 have favorable views of physical therapists, and the majority see considerable value in the services they provide. Nearly the same number (88%) expressed concerns that proposed Medicare payment cuts may eliminate alternatives for therapy outside of nursing homes and eliminate seniors’ ability to age in place. More than three in four respondents (76%) say it is important for them to be able to access their physical therapist when they cannot come into the office for an in-person appointment.

Care professionals across the healthcare continuum — from skilled therapists to physicians to nurse practitioners and physicians’ assistants — recognize the negative impact these cuts would have on their patients, and support efforts in Congress to address these cuts in the year ahead.

Bipartisan lawmakers in Congress have introduced legislation to block these harmful cuts from taking effect in 2023, an essential step toward ensuring all Americans can access quality physical therapy and other specialty services. The Supporting Medicare Providers Act of 2022 (H.R. 8800) would block Medicare’s Physician Fee Schedule cuts by providing an additional 4.42% to the conversion factor for 2023.

It’s inconceivable to think we can continue to provide thorough care without one of the most essential elements — therapy. We hope that Congress will act — and quickly before the end of the year — so that our critically important healthcare standards for patients suffering from a multitude of diseases, injuries, and conditions are not irrevocably undermined.

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