COVID-19 rapid test recalled for ‘high number’ of false positive reports

COVID-19 rapid test recalled for ‘high number’ of false positive reports

https://www.foxbusiness.com/healthcare/covid-19-rapid-test-recalled-for-high-number-of-false-positive-reports

The Food and Drug Administration announced Wednesday that a healthcare company has recalled 45,500 COVID-19 rapid tests due to a “high number of false positive reports.”

Pharmaceutical company Celltrion USA announced on Feb. 28 it is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to the high number of false-positive reports, an FDA recall webpage read on Wednesday.

The FDA says that a false-positive test result can lead to a delay in “the correct diagnosis and treatment for the actual cause of a person’s illness.”

The COVID-19 rapid tests also displayed a shelf life of 18 months, but the FDA’s emergency use authorization states that the tests can only be used for 12 months.

Individuals and customers who received the effected COVID-19 rapid tests are being told to discontinue use and return the unused products.

“The use of the affected product could cause serious adverse health consequences and death,” the FDA webpage states.

On Wednesday, the FDA also announced the recall of the SD Biosensor STANDARD Q COVID-19 Ag Home Test, stating the test is not approved by the FDA for marketing or distribution in the United States.

Since the test was not authorized by the FDA, the government agency said “there is not sufficient data demonstrating that the test’s performance is accurate,” which could lead to inaccurate results.

“This means there is a risk of both false-negative and false-positive test results. False negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected. False-positive results occur when the test says the person has SARS-CoV-2 virus present, but they are not infected,” the website states.

Should the DEA pay attention to what is going on in FL with STING OPERATIONS ?

Case Against Florida Cannabis Doc Goes Up in Smoke

Judge clears Joseph Dorn, MD, who was the target of an undercover sting operation

https://www.medpagetoday.com/special-reports/exclusives/97760

An administrative law judge in Florida issued a decision in favor of Joseph Dorn, MD, whose medical cannabis clinic was targeted by the state’s Department of Health in an undercover sting.

The department sent two investigators posing as patients to Dorn’s clinic in Tallahassee in November 2017 and April 2018. The first investigator said he was a 30-year-old delivery driver with anxiety, PTSD, and chronic pain, while the second claimed to be a 37-year-old construction worker and former Marine with PTSD.

In 2019, the Department of Health filed a license-threatening administrative complaint against Dorn, claiming its sting operation had found that he failed to conduct a full assessment of patient medical histories before prescribing medical cannabis, and that he acted in a manner to defraud or trick patients.

Though the COVID-19 pandemic delayed a hearing in the case until late last year, a decision by Judge W. David Watkins on March 16 stated that the Department of Health failed to prove any of its claims against Dorn.

“The evidence of record undermines DOH’s argument that Dr. Dorn’s practice is nothing more than an ‘open gate’ to medical marijuana,” Watkins wrote in his decision. “In the case of both [investigators] (and presumably the other 28 patients examined), Dr. Dorn conducted a detailed and thorough assessment of the patient’s condition prior to prescribing medical marijuana.”

Watkins further wrote that the evidence in the case demonstrates that Dorn performed a meaningful review of the investigators’ medical histories and symptoms, identified and discussed their qualifying stressors, and noted the PTSD symptoms they said they experienced. The judge added that Dorn documented the severity of the PTSD symptoms through two rating scales, and discussed the benefits and risks of medical marijuana with each of the investigators.

The decision also addressed the Department of Health’s argument that Dorn defrauded or tricked patients by including false representations in the investigators’ medical records, failed to create or complete their records until subpoenaed, operated without the necessary medical equipment to conduct adequate physical examinations, charged $299 per new patient appointment for the sole purpose of adding patients to the medical marijuana user registry, and ordered marijuana for more than 3,000 new patients in a 12-month timeframe.

“DOH failed to present competent substantial evidence in this case establishing, particularly under a clear and convincing evidence standard, that Dr. Dorn acted, or failed to act, in any manner to defraud or trick any patient, or that any patient was actually defrauded or tricked,” Watkins wrote.

Ultimately, Watkins recommended that the Department of Health issue a final order dismissing the administrative complaint against Dorn. The department had sought to strip Dorn of his medical license for 5 years, ban him from ordering medical marijuana for patients, and impose a $10,000 fine, the News Service of Florida reported.

“We feel great about the result, and frankly are not surprised. Dr. Dorn is an incredible physician with an even stronger reputation. Hopefully this ruling will now help the DOH finally understand the statutes they are charged to enforce,” wrote Ryan Andrews, of the Andrews Law Firm in Tallahassee, who represents Dorn, in an email to MedPage Today.

“Nonetheless, this saga is not over,” Andrews added. “Now it’s our turn to pursue in circuit court DOH and every individual that was involved in this investigation.”

The Department of Health did not immediately respond to a request for comment.

Corporate policies is more important to a Vanderbilt prescriber that a pediatric cancer pt’s quality of life ?


I was involved in on this “remotely” via phone with Bob & Johanna who were there in person.  Any time that Bob runs into a medication question when he is advocating… my phone rings.  I am more than happy to provide Bob with the “factual ammunition” in advocating for a pt. Apparently this practitioner is JUST AN EMPLOYEE OF VANDERBILT HOSPITAL… and if he was concerned about liabilities – he shouldn’t have become a physician…  I suspect that VANDERBILT is another large hospital corporation that has adopted a “little/no opiate” policy.  The medication that this kid was on previously was not doing a very good job on reducing their pain and there is NO RECOMMENDATION FOR DOSES FOR KIDS… and this physician wanted to take the kid off of a opiate – that I had previously recommended – that was reducing their pain and improving their QOL and giving the FAMILY more quality time together, with what time that the kid has left.

I know that if a parent INTENTIONALLY inflicted as much pain on one of their kids , as this kid was going to experience if he was put back on the medication that was not working well for them…  Child Protective Services would be knocking at their door. Isn’t it amazing in our society that health care practitioners can INTENTIONALLY inflict pain on a pt – by taking away or lowering their pain meds – and NO ONE IS IN TROUBLE….  EXCEPT THE PT HAVING TO EXIST IN PAIN.

Maybe it is time that the chronic pain community start using LAW FIRMS to advocate for us

APDF learned yesterday if you spank your kid the government will punish you! But It’s entirely ok for the government to torture your child (Guantanamo Bay style) if they are suffering from rare diseases or end of life issues! Then the idea was to change the child from a schedule 2 that has reported to be working to a schedule 4 when the child only has 3 to 6 months left to live. Then he proceeded to tell us his liabilities and hospital policies! Then he spread his God like knowledge upon us like we were in kindergarten! Well that backfired when he met the KING OF ARGUMENTS! I may let Amanda win from time to time but he ain’t Amanda! At the end of the day we let it known that child services and an attorney will be contacted and paid for by American Pain And Disability Foundation and not to mention having several picketing signs outside his beautiful home and hospital establishment.. they decided to leave the child on the current medication that was previously agreed to from a previous appointment as long as I wasn’t allowed back to Advocate for said child any longer 🤣 I told the mom make the deal and if they go back on it…. we will be back. Deals a deal right? Oh and he also said,” something about F###ing a##hole before leaving abruptly! 😬 🤣After all we aren’t looking for credit but I’ll be damned if we were gonna let that impede my other 14 children and start a new ”policy” especially at Vanderbilt Children’s Hospital where we have worked so hard and it would spread like wildfire! Anyways we also went to Methodist Hospital were we were successful in helping the last of the 15 children get end of life care and a special thank you to Methodist Hospital for stepping up for these kids! A special thank you goes out to Methodist Hospital & Johnna Magers and Steve Ariens and the rest of the APDF team for taking up your whole day! You are truly Amazing people! I was home about 3 minutes before I passed out from 6pm to 5 am and thank God because obviously my old beat up ass body was ready for that! 🤣 OH and 14-1 is not a bad Advocating record for a bunch of pain patients with bad attitudes but with alot of knowledge 🤣 more thank yous go out to all the folks who helped along the way Andrew Hohenthaner Carol Adams Dr Anthony Mimms Shirley Buck Stacy Siano Ashley Michel Karlyn Beavers Karen Wilkinson & Cheri Mendes for awesome articles…. Thank You!

WAGS: corporate greed: overcharging insurance and pts – profits at any cost ?

Walgreens sued by BCBS payers, health systems for alleged drug overcharging fraud scheme

https://www.beckerspayer.com/payer/walgreens-sued-by-bcbs-payers-health-systems-for-alleged-drug-overcharging-fraud-scheme.html

Blue Cross Blue Shield affiliates and other payers are suing Walgreens for allegedly overcharging payers and customers for prescription drugs.

Court documents filed March 15 in the U.S. District Court for the Northern District of Illinois Eastern Division claim that Walgreens “knowingly and intentionally engaged in an ongoing fraudulent scheme” to overcharge payers by submitting claims with artificially inflated drug prices.

The lawsuit alleges that Walgreens concealed the fraud scheme by making false statements and leaving out facts related to its true usual and customary prices for prescriptions given to the individuals enrolled in the plaintiff’s health plans. The suit alleges that Walgreens overcharged payers and health systems by hundreds of millions of dollars for more than a decade by submitting falsely inflated usual and customary prices on millions of reimbursed claims.

The plaintiffs named in the suit are CareFirst of Maryland, Group Hospitalization and Medical Services, CareFirst BlueChoice, Blue Cross Blue Shield of South Carolina, BlueChoice HealthPlan of South Carolina, Louisiana Health Service and Indemnity Co., Blue Cross and Blue Shield of Louisiana, and HMO Louisiana.

The court documents say that plaintiffs are owed at least the amount of money they were overcharged on reimbursement claims.

The suit also says that Walgreens’ alleged scheme affected consumers directly. By purchasing prescription drugs from Walgreens’ pharmacies with falsely inflated prices, payers increased copays, coinsurance, deductibles and premiums.

The lawsuit claims that Walgreens’ alleged fraudulent actions are still happening and that the company continues to report falsely inflated prices for payer claims. Because of this, the plaintiffs believe they are still threatened with future harm from Walgreens.

Walgreens declined to provide a comment to Becker’s Hospital Review.

Here is another blog post from today… https://www.pharmaciststeve.com/colorado-wags-pharmacy-techs-shine-light-on-shortages-delays-mistakes/

suggests that WAGS is under paying their Rx dept employees, while at the same time under staffing and over working the same employees. It is almost like WAGS is “pocket-picking” just about everyone’s pockets that deals with them – at least in the Rx dept.

Colorado WAGS pharmacy techs shine light on shortages, delays, MISTAKES

Colorado pharmacy techs shine light on shortages, delays

https://www.thedenverchannel.com/news/contact-denver7/colorado-pharmacy-techs-shine-light-on-shortages-delays

After almost seven years as a pharmacy technician at a Centennial Walgreens, Melanie- who asked Denver7 to not use her last name to protect her privacy- quit right before her shift last summer.

“I just sent a message to my store manager, and I said, ‘I’m really sorry. I know that multiple people have done this now, but I am to the point where I can’t do it anymore,'” said Melanie. “I couldn’t even get out of bed that day. I physically couldn’t handle the stress anymore.”

She still has a copy of her six-day-a-week Walgreens work schedule from last year, as well as text after text begging her for help.

“I told my managers, ‘We need help. We need to find people. We need bodies that can count by five,'” Melanie said, recalling how pharmacy workers had to juggle prescriptions, COVID-19 shots, vaccinations and even stocking the store, all with no breaks.

“Mistakes happened all the time,” she said. “It was a matter of if we were able to get the patient to come back and correct it, make sure that they left happy so their report didn’t have to get filed. My pharmacists on a daily basis were scared they were going to be losing their license. To get all of that stuff done on top of vaccines on top of testing, it’s not possible. It’s physically not possible.”

Ali DiLorenzo has been a pharmacy tech at Wheat Ridge Professional Pharmacy for more than a decade and says Walgreens has a reputation in the industry.

“They are overworked, underpaid, and understaffed. They’re closing. You can’t get a hold of anybody. I mean, it’s just a nightmare,” said DiLorenzo. “You’re in a field where you make a mistake, you could kill somebody.”

The Colorado Pharmacists Society tells Contact Denver7 that the issue is much larger than Walgreens, stemming back to insurance companies not reimbursing pharmacies for the full cost of drugs.

“The margins have continued to be less and less and less and less. Sometimes we’re getting paid 10 cents to dispense a prescription. That used to be $10,” said Emily Zadvorny, executive director of the Colorado Pharmacists Society. “So when you have a situation where, whether that’s a chain or an independent, where they can barely scrape by to make enough money to keep the doors open, they’re certainly not going to be able to hire four more pharmacists.”

Zadvorny says pharmacies have no choice but to sign contracts with the three big health plans, which then reimburse pharmacies for less than the cost of the drug.

“I see it as them forcing you basically to go to mail order where they don’t have to staff in-house pharmacy,” said DiLorenzo. “Obviously, the insurance companies and the drug companies are making a ton of money. But the pharmacies themselves are not most of them are operating at a loss.”

While Wheat Ridge Professional Pharmacy has been taking on more patients, they say they can only take on so many if they are not being reimbursed.

Contact Denver7 reached out to Walgreens, and a spokesman released this statement:

While we are grateful for the hard work and dedication of our pharmacy staff, we also recognize some of the challenges facing our team members — and healthcare workers in general – in the current environment.   We continue to take steps to help mitigate current staffing pressures, including hiring thousands of new pharmacy team members, adjusting vaccine appointment availability and store hours as needed and expanding remote pharmacy capabilities to help reduce workload. 

Melanie says she is now much happier working for a different company in a more clinical setting and is making twice as much. She wants patients who are waiting in long lines for delayed prescriptions to understand that there is more to the story.

“I feel like a lot of patients would come through and be so upset because they’re like, ‘You don’t care. You don’t even care.’ We do! I mean, I had techs leaving in tears on a daily basis because they just couldn’t handle the stress,” she said. “It’s not a matter of Walgreens not being able to find people to work. It’s that people don’t want to work for minimum wage in unworkable conditions.”

Editor’s note: Denver7 seeks out audience tips and feedback to help people in need, resolve problems and hold the powerful accountable. If you know of a community need our call center could address, or have a story idea for our investigative team to pursue, please email us at contact7@thedenverchannel.com or call (720) 462-7777. Find more Contact Denver7 stories here.

You only have ONE LIFE…. ONE HEALTH…. don’t let corporate greed cause you to loose either one

Clock is ticking on making a comment on the proposed 2022 CDC opiate dosing guidelines

Did anyone notice that seemingly innocuous link to the left top of on this page  https://www.regulations.gov/commenton/CDC-2022-0024-0001  When you click on it… the rest of this post is what shows up …

  • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters  
  • this line could be the most important line in the entire text…  “well supported comment” could very well me a comment with references to clinical studies to support the statement… the 211 page 2022 proposed dosing guidelines contained 20 pages of footnotes and references.  And in looking at those 20 pages… one whole page had references with one of the author of each reference being one of the 5 who wrote/supervised the creation of this proposed guidelines.
  • Historically, pt’s personal observation of health/pain issues are discounted as being anecdotal and of no clinical value, since they are considered as potentially biases and did not follow some sort of approved protocol and thus your submission may not be considered “well supported”
  • There is about three weeks left to make comments. Right now there is abt 2600 comments have been accepted and posted. Just how many of comments from pts will have any influence on the final 2022 guidelines when they are published. We may never know, you can use the link above to go to the page to make a comment.

Write a Comment

Commenter’s Checklist

https://www.regulations.gov/commenton/CDC-2022-0024-0001

Independent Pharmacy: if there is a problem, make sure you are talking to THE BOSS/OWNER

A intractable chronic pain reached out to me … concerning a new pharmacist at a pharmacy she had been patronizing for years, and this pharmacist decided that the medication that this pt had been taking for years – by the book – had some potential interactions that the pharmacist “had concerns about”.  Was hassling the pt about filling them. The next day the pt talk to the pharmacist at the pharmacy who had filled her Rxs before and that pharmacist declined to fill her Rxs.  Maybe the first pharmacist was more of a “bully” and the second pharmacist was more of a “wimp”.
If this had been the first time that the pt was coming to have these medications filled, I could understand the pharmacist’s concern and may there would have been a need to have a conversation with the prescriber over the pharmacist’s concerns of POTENTIAL INTERACTIONS… but because the pt had been taking these meds for several years. The concerns of POTENTIAL INTERACTIONS should have been quickly viewed as a non-concern.

I was surprised of this sort of attitude from a independent pharmacy, I had own my own pharmacy for 20 yrs and pretty familiar with the typical mindset of a independent pharmacy owner.  This independent pharmacy was one of  a “multi-store” independent and the owner of the stores did not work in this store. The pt was ready to discontinue the use of one or more of her medications.  I suggest to the pt that she reach out to the OWNER of this store, that he/she may not be aware of  how this new employee was dealing with the store’s pts’ medication needs.

The pt took my recommendation, and reached out to the owner… but had to leave a message… HOWEVER.. the owner did contacted the pt by the end of the that same day.  Apologized PROFUSELY for how she was treated…. and the pharmacy DELIVERED her medications the very next day at NO CHARGE.

This is excellent example why I suggest that pts that are having trouble/issues with chain pharmacies filling their Rxs, that they find a local independent pharmacy and I regularly share this link to find a independent pharmacy by zip code https://ncpa.org/pharmacy-locator

The typical chain pharmacist and the Rx dept is GROSSLY UNDERSTAFFED and GROSSLY OVERWORKED.  I have seen some chain pharmacist making statements on some private/closed pharmacist FB pages that they are upwards of TEN DAYS BEHIND IN FILLING PRESCRIPTIONS.   Here is a PUBLIC FACE BOOK PAGE https://www.facebook.com/PizzaIsNotWorking that one particular pharmacist has started creating a rebellion of chain pharmacists … I believe that the “final straw” genesis of that revolt was triggered by what I shared on this blog post https://www.pharmaciststeve.com/cvs-pharmacist-dies-on-the-job-from-cardiac-mi-forced-to-wait-for-relief-pharmacist-to-show-up/

Why are independent pharmacies better staffed ?  Most independents are normally not sitting on “high price real estate”…  they don’t have to financially support layers of upper management and a large corporate headquarter bldg, their stores are much smaller and few-if any – have 24 hr operations and they depend more on word of mouth advertisement than large multi media advertising campaigns.  They commit all those financial resources to better staffing and better pt services.

 

 

 

What’s your story: pt leaving our country to find better pain management


Hi I’m Sam I’ve have RSD, chronic migraines pcos, TD, neuralgia.
After everything I’ve tried in my 21 years of chronic pain I decided to leave my country because of the cdc guidelines. My pharmacy of 16 years got raided for doing the right thing and continued to help us chronic pain patients out. My PM doctor was forced tapering me to nothing as I was withdrawaling with my toddler near me, they didn’t care that I had a little one to take care of.
So I made the toughest decision to move out of the country for better pain care and for my husband’s family’s help to watch our child. Unfortunately my husband couldn’t come with me and I probably won’t see him for a very long time because he needs to make the money to keep care of me in Guatemala because let’s face it, I’ll never get better but atleast I’ll have the quality of life since before the opioid crisis began. And I was able to get my anxiety medication back over here after 7 years because it was a benzodiazepine and im taking a pain medication on top of it and I’m not dying or in danger like the cdc states. I took that combination for years before the cdc stuck their noses where it didn’t belong.
This is the craziness we must face now, chronic pain patients moving out of our country for better pain care and leaving your loved ones behind?

what’s your story ?

A chronic pain pt asked if I would share their story…

So I am not only going to share this pt’ story,  I have created a NEW TAB on the first page of my blog and will put links to pt’s stories who share in the future

If you have a story you want shared sent it to steve@steveariens.com

Dr WALMART will be with you shortly… feel free to walk around the store.. we will text you.. we are a little behind

Spine group launches franchise following Walmart pilot

https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/53851-spine-group-launches-franchise-following-walmart-pilot.html

Brentwood, Tenn.-based IMAC Holdings plans to launch a franchise of spinal health and wellness centers called The Back Company on April 1.

The franchise follows the July launch of The Back Space, a chain of retail spine clinics piloted in Walmart stores. 

The Back Company will provide chiropractic adjustments, corrective instrument adjusting and percussion therapies for soft tissue recovery, muscle relaxation and spinal wellness, the company said in a March 15 news release. Services are priced at $25 per treatment, with memberships available for $65 per month, in addition to family and wellness plans.

The franchises will be positioned in retail centers, large retail stores and medical facilities.

“We have the ability to leverage a competitive advantage in a $20 billion industry that will efficiently utilize capital to increase storefronts quickly through franchising,” said Jeff Ervin, CEO of IMAC. “Our pilot allowed us to develop our technical infrastructure, refine the services and messaging and implement the infrastructure needed to launch the franchise program. With the majority of the pilot program expenses behind us, this initiative will reverse the course from cash outlay into cash receipts for the intellectual property we have developed.”