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Is the CDC’s recommendations just inaccurate or based on some sort of strange agenda ?
Posted on August 9, 2021 by Pharmaciststeve
Why Would CVS Abruptly Cut Off a Certified Pain Management Specialist — Without a Reason or Investigation?
Posted on August 8, 2021 by Pharmaciststeve
Why Would CVS Abruptly Cut Off a Certified Pain Management Specialist — Without a Reason or Investigation?
Pharmacy’s Data-Driven Method of Fighting the Opioid Epidemic Hurts Physicians and Patients Alike. Our Lawsuit Reveals Why
In the so-called “war on prescription drugs,” the DEA and national pharmacy chains have put up a strong arsenal to root out the rogue physicians who are running pill mills. But all too often, it’s the certified, licensed pain management specialists who have become the figurative casualties in this battle. In turn, their patients, who have serious, debilitating conditions, end up becoming the actual ones.
A federal lawsuit we at Chapman Law Group recently filed against CVS — the second-largest pharmacy chain in the U.S. — is just of the many astonishing examples of why the system is failing.
How Does One Phone Call Lead to a National Pharmacy Chain Making a Terse Decision?
Our physician client runs a Northern Kentucky interventional pain management specialty practice. As part of the rigorous compliance policy for the controlled substances his practice prescribes, he and his staff closely monitor patients to detect any signs of “doctor shopping” and drug diversion, using urine screenings and the state automated prescription reporting system.
In June 2021, a representative from CVS’s corporate office called the physician with questions about his practice and his prescribing procedures. The representative did not give any indication that any of the physician’s prescriptions were suspect. Moreover, none of the physician’s prescriptions had ever been questioned or rejected by CVS or third-party payors as being medically unnecessary.
Nonetheless, on July 28, 2021, CVS sent a letter to the physician stating that its pharmacy locations would no longer continue filling the physician’s prescriptions. This is medication that we know to be supported by medical necessity and serving a legitimate medical purpose. But CVS does not see it this way.
Making things worse, CVS did not provide any reason — valid or otherwise — in its letter for the exclusion. It simply cut him off.
What Does This Pain Management Specialist and His Patients Stand to Lose? Plenty
Because CVS is saying no to filling these legitimate prescriptions, and not giving an explanation for doing so, the physician’s practice and reputation will suffer tremendously:
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- Because CVS wields influence, other large-scale pharmacies and local, independent pharmacies will follow suit and cut off our client’s prescriptions, “for fear of regulatory scrutiny.” His practice, in turn, will have a stigma attached to it.
- “Blanket refusal” of our client’s prescriptions will lead to not just business loss, but also “inadequate treatment to its patient population” — a patient population that, for 25 years, our client swore to serve and to “do no harm.”
For his patients who have chronic pain conditions, being told by CVS that it will no longer fill their prescriptions means:
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- These patients will be under the false impression that their doctor has a history of writing prescriptions that are “illegitimate, improper, illegal or otherwise not keeping with the standards of care …,” and may want to drop him as their physician.
- If they do drop him, these patients will have to start all over again with a new physician. This replacement physician won’t be able to simply continue where their previous physician — who, in his years of treating them, has a direct knowledge of their conditions and needs — left off, and their pain conditions may get worse in the interim period.
- Things won’t be easy for them when searching out other pain management specialists, considering the shortage of physicians who specialize in pain treatment.
- If these patients do stay with our client physician, they will have to seek another pharmacy to fill their prescriptions. In doing so, they could be wrongly labeled as “pharmacy shoppers” by that pharmacy, and perhaps others, for switching.
Why is CVS in the Wrong? Look at Its History — and Its Troublesome Prescription Method
CVS, which has nearly 10,000 locations nationwide, has had a spotty go of it regarding the war on opioids. In 2015 it ponied up $22 million to the DEA for improper opioid distribution, then it paid $8 million the next year for unlawful distribution of controlled substances.
But it’s the “drug monitoring program,” which CVS put in place in 2012, that is the most problematic — and it accounts for our client being in the position he’s in with the pharmacy.
This system “uses algorithms to gather aggregate data on physician prescribing practices to identify physicians who demonstrate extreme patterns of prescribing certain highly regulated drugs.” Any physician who gets “flagged” by CVS is then interviewed and investigated.
Did our client undergo an investigation before CVS took action against him?
No.
CVS did not look at medical records or charts, patient pharmacy profiles, or individual patient data. It did not talk to any patients. It did not conduct inspection of our client’s practice. It did not single out any prescription as illicit.
All it did was go by statistical data and a single phone call.
But CVS is not the only entity to do things this way. The federal government employs the same tactics.
As Ronald W. Chapman II, who chairs Chapman Law Group’s White Collar Defense & Government Investigations practice group and filed this immediate lawsuit, told the Center for Effective Regulatory Policy & Safe Access on its “Pain Politics” podcast:
“[W]e’re seeing in more recent cases, [Department of Justice] prosecutions are data driven. Prosecutions are initiated before an investigator has even looked at a medical record, before an investigator has even interviewed a patient. And in many cases, even though patients are clearly suffering from severe medical issues, the fact that a patient may have exhibited some signs of diversion or may have had a prior history of diversion is enough for federal prosecutors to move forward and indict that doctor.”
At Chapman Law Group, Our Healthcare Attorneys Fight to Secure Pain Management Specialists’ Reputation and Rights
We are aware that, yes, there are physicians who go outside “the bounds of professional practice” by drug trafficking. In fact, we at Chapman Law Group are currently asking the U.S. Supreme Court to apply a definitive standard for prescribing controlled substances; this would remove any ambiguity over whether a practitioner stopped being a physician and instead served as a drug dealer.
But without providing solid proof that our client had done just that, CVS is tarnishing his reputation, torpedoing his career, and adding more pain to his patients.
With this lawsuit, we want CVS — and all other large-scale pharmacies — to get the message: the practice of algorithmically singling out legitimate practitioners, and not providing due process, is flawed. As national healthcare attorneys who are dedicated to preserving the livelihood of pain management specialists and other licensed healthcare professionals, we will not stand for it.
Need an Attorney? Contact us now!
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Covid-19 natural immunity compared to vaccine-induced immunity: The definitive summary
Posted on August 8, 2021 by Pharmaciststeve
Covid-19 natural immunity compared to vaccine-induced immunity: The definitive summary
Updated Aug. 6 with CDC analysis of Kentucky (unvaccinated Kentuckians had “2.34 times the odds of reinfection” compared with fully vaccinated) and national analysis in Israel (vaccinated Israelis were 6.72 times more likely to get infected after the shot than after natural infection). More below.
Sen. Lindsey Graham (R-S.C.) became one of the latest high-profile figures to get sick with Covid-19, even though he’s fully vaccinated. In a statement Monday, Graham said it feels like he has “the flu,” but is “certain” he would be worse if he hadn’t been vaccinated.
While it’s impossible to know whether that’s the case, public health officials are grappling with the reality of an increasing number of fully-vaccinated Americans coming down with Covid-19 infections, getting hospitalized, and even dying of Covid. The Centers for Disease Control (CDC) insists vaccination is still the best course for every eligible American. But many are asking if they have better immunity after they’re infected with the virus and recover, than if they’re vaccinated.
Increasingly, the answer within the data appears to be ”yes.”
Why does CDC seem to be “ignoring” natural immunity?
In fact, some medical experts have said they’re confounded by public health officials’ failure to factor natural and virus-acquired immunity into the Covid equation. Public and media narratives often press the necessity of “vaccination for all,” chiding states where vaccination rates are lowest. And they use vaccination rates and Covid case counts as inverse indicators of how safe it is in a particular state: high vaccination rate = high safety; high case counts = low safety (they claim).
Read: Covid-19 natural immunity vs. vaccine-induced immunity
However, vaccination rates alone tell little about a population’s true immune-status. And where high Covid case counts occur, it ultimately means a larger segment of that community ends up better-protected, vaccines aside. That’s according to virologists who point out that fighting off Covid, even without developing any symptoms, leaves people with what’s thought to be more robust and longer-lasting immunity than the vaccines confer.
The vaccine immunity problem
Hard data counters widespread public misinformation that claimed “virtually all” patients hospitalized and dying of Covid-19 are unvaccinated. Pfizer and Moderna had claimed their vaccines were “100% effective” at preventing serious illness. Many in the media even popularized a propaganda phrase designed to push more people to get vaccinated: “pandemic of the unvaccinated.”
Not so, says CDC and other data.
Recent CDC data found that 74% of those who tested positive for Covid-19 in a Massachusetts analysis had been fully-vaccinated. Equally as troubling for those advocating vaccination-for-all: four out of five people hospitalized with Covid were fully-vaccinated. And CDC said “viral load” — indicating how able the human host is to spread Covid-19 — is about the same among the vaccinated and unvaccinated. Contrary to the infamous misinformation by CDC Director Rochelle Walensky last May, vaccinated people can— and are— spreading Covid. (CDC officials later corrected Walensky’s false claim.)
Below: CDC’s data with light blue showing fully vaccinated. Dark blue is unvaccinated (but may include some fully vaccinated.)
(READ) Covid-19 Vaccine Analysis: the most common adverse events reported so far
CDC’s newest findings on so-called “breakthrough” infections in vaccinated people are mirrored by other data releases.
Illinois health officials recently announced more than 160 fully-vaccinated people have died of Covid-19, and at least 644 been hospitalized; ten deaths and 51 hospitalizations counted in the prior week. Israel’s Health Ministry recently said effectiveness of the Pfizer-BioNTech vaccine has fallen to 40 percent. Last month, 100 vaccinated British sailors isolated on a ship at sea reportedly came down with Covid seven weeks into their deployment. In July, New Jersey reported 49 fully vaccinated residents had died of Covid; 27 in Louisiana; 80 in Massachusetts. In Iceland there is a spike in cases, mostly among the vaccinated, among a highly-vaccinated population that had previously claimed to have defeated Covid-19. Of 116 cases diagnosed in one day, 73 were among the vaccinated; 43 were unvaccinated.
Nationally, as of July 12, CDC said it was aware of more than 4,400 people who got Covid-19 after being fully vaccinated and had to be hospitalized; and 1,063 fully vaccinated people who died of Covid. But health officials still argue that vaccinated people make up only a small fraction of the seriously ill. Critics counter that CDC’s recent Massachusetts data calls that into question.
Update August 6: CDC has released a small analysis in Kentucky and indicated that it’s proof that vaccines are more effective than natural immunity. Read the analysis here. According to CDC, among the reinfected sample, 20% had been fully vaccinated. Among those who had Covid and were not later reinfected, 66% were unvaccinated. “Kentucky residents who were not vaccinated had 2.34 times the odds of reinfection compared with those who were fully vaccinated.”
Updated August 6: In Israel, more than 7,700 new cases of the virus have been detected during the most recent wave starting in May, but just 72 of the confirmed cases were reported in people who were known to have been infected previously – that is, less than 1% of the new cases. Roughly 40% of new cases – or more than 3,000 patients – involved people who had been infected despite being vaccinated. By contrast, Israelis who were vaccinated were 6.72 times more likely to get infected after the shot than after natural infection, with over 3,000 of the 5,193,499, or 0.0578%, of Israelis who were vaccinated getting infected in the latest wave.
The bright side of recovering from Covid-19
But there’s promising news to be found within natural and acquired immunity statistics, according to virologists. As of May 29, CDC estimated more than 120 million Americans— more than one in three— had already battled Covid. While an estimated six-tenths of one-percent died, the other 99.4% of those infected survived with a presumed immune status that appears to be superior to that which comes with vaccination.
If doctors could routinely test to confirm who has fought off and become immune to Covid-19, it would eliminate the practical need or rationale for those protected millions to get vaccinated. It would also allow them to avoid even the slight risk of serious vaccine side effects.
Unfortunately, virologists say no commonly-used test can detect with certainty whether a person is immune. A common misconception is that antibody tests can make that determination. But experts say immunity after infection or exposure often comes without a person producing or maintaining measurable antibodies.
Because of that reality, people who have had asymptomatic infections — infections where they suffered no symptoms — have no easy way to know that they’re immune. However, a growing body of evidence indicates that the millions who know they got Covid can be assured they’re unlikely to suffer reinfection, for at least as long of a time period that scientists have been able to measure. Possibly far beyond.
The immunity-after-Covid-infection studies
The following are some of the data and studies regarding immunity acquired after Covid infection.
This study followed 254 Covid-19 patients for up to 8 months and concluded they had “durable broad-based immune responses.” In fact, even very mild Covid-19 infection also protected the patients from an earlier version of “SARS” coronavirus that first emerged around 2003, and against Covid-19 variants. “Taken together, these results suggest that broad and effective immunity may persist long-term in recovered COVID-19 patients,” concludes the study scientists.
This study of airline passengers in Qatar found that both vaccination and prior infection were “imperfect” when it comes to preventing positive Covid-19 test results, but that the incidence of reinfection is similarly low in both groups.
Necessity of COVID-19 vaccination in previously infected individuals, June 1, 2021
This study followed 52,238 employees of the Cleveland Clinic Health System in Ohio.
For previously-infected people, the cumulative incidence of re-infection “remained almost zero.” According to the study, “Not one of the 1,359 previously infected subjects who remained unvaccinated had a [Covid-19] infection over the duration of the study” and vaccination did not reduce the risk. “Individuals who have had [Covid-19] infection are unlikely to benefit from COVID-19 vaccination,” concludes the study scientists.
SARS-CoV-2 specific memory B-cells from individuals with diverse disease severities recognize SARS-CoV-2 variants of concern, May 29, 2021
This study found strong immune signs in people who had previously been infected with Covid-19, including “those [who] experienced asymptomatic or mild disease.” The study concludes there is “reason for optimism” regarding the capacity of prior infection “to limit disease severity and transmission of variants of concern as they continue to arise and circulate.”
A population-based analysis of the longevity of SARS-CoV-2 antibody seropositivity in the United States, May 24, 2021
This study of real world data extended the timeframe of available data indicating that patients have strong immune indicators for “almost a year post-natural infection of COVID-19.” The study concludes the immune response after natural infection “may persist for longer than previously thought, thereby providing evidence of sustainability that may influence post-pandemic planning.”
SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans, May 24, 2021
This study examined bone marrow of previously-infected patients and found that even mild infection with Covid-19 “induces robust antigen-specific, long-lived humoral immune memory in humans.” The study indicates “People who have had mild illness develop antibody-producing cells that can last lifetime.”
People who have had mild illness develop antibody-producing cells that can last lifetime.
World Health Organization (WHO) scientific brief, May 10, 2021
This scientific brief issued by WHO states that after natural infection with Covid-19, “available scientific data suggests that in most people immune responses remain robust and protective against reinfection for at least 6-8 months.”
Detection of SARS-CoV-2-Specific Humoral and Cellular Immunity in COVID-19 Convalescent Individuals, May 3, 2020
This study found humoral and cellular immunity in recovered Covid patients. “Production of S-RBD-specific antibodies were readily detected in recovered patients. Moreover, we observed virus-neutralization activities in these recovered patients,” wrote the study authors.
The adaptive immune system consists of three major lymphocyte types: B cells (antibody producing cells), CD4+ T cells (helper T cells), and CD8+ T cells (cytotoxic, or killer, T cells
Protection of previous SARS-CoV-2 infection is similar to that of BNT162b2 vaccine protection: A three-month nationwide experience from Israel, April 24, 2021
This study from Israel found a slight advantage to natural infection over vaccination when it comes to preventing a reinfection and severe illness from Covid-19.
The study authors concluded, “Our results question the need to vaccinate previously-infected individuals.”
A 1 to 1000 SARS-CoV-2 reinfection proportion in members of a large healthcare provider in Israel: a preliminary report, March 6, 2021
This study found a rare Covid-19 positive test “reinfection” rate of 1 per 1,000 recoveries.
Lasting immunity found after recovery from COVID-19, Jan. 26, 2021
Research funded by the National Institutes of Health and published in Science early in the Covid-19 vaccine effort found the “immune systems of more than 95% of people who recovered from COVID-19 had durable memories of the virus up to eight months after infection,” and hoped the vaccines would produce similar immunity. (However, experts say they do not appear to be doing so.)
SARS-CoV-2 reinfection in a cohort of 43,000 antibody-positive individuals followed for up to 35 weeks, Jan. 15, 2021
This study found Covid-19 natural infection “appears to elicit strong protection against reinfection” for at least seven months. “Reinfection is “rare,” concludes the scientists.
Immunological memory to SARS-CoV-2 assessed for up to eight months after infection, Nov. 1, 2020
This study confirmed and examined “immune memory” in previously-infected Covid-19 patients.
Negligible impact of SARS-CoV-2 variants on CD4+ and CD8+ T cell reactivity in COVID-19 exposed donors and vaccinees, Nov. 1, 2020
This study concluded “T cell” immune response in former Covid-19 patients likely continues to protect amid Covid-19 variants.
Orthogonal SARS-CoV-2 Serological Assays Enable Surveillance of Low-Prevalence Communities and Reveal Durable Humoral Immunity, Oct. 13, 2020
This study found that “neutralizing antibodies are stably produced for at least 5–7 months” after a patient is infected with Covid-19.
SARS-CoV-2-specific T cell immunity in cases of COVID-19 and SARS, and uninfected controls, July 25, 2020
This study found that all patients who recently recovered from Covid-19 produced immunity-strong T cells that recognize multiple parts of Covid-19.
They also looked at blood samples from 23 people who’d survived a 2003 outbreak of a coronavirus: SARS (Cov-1). These people still had lasting memory T cells 17 years after the outbreak. Those memory T cells, acquired in response to SARS-CoV-1, also recognized parts of Covid-19 (SARS-CoV-2).
Much of the study on the immune response to SARS-CoV-2, the novel coronavirus that causes COVID-19, has focused on the production of antibodies. But, in fact, immune cells known as memory T cells also play an important role in the ability of our immune systems to protect us against many viral infections, including—it now appears—COVID-19.
“Immune T Cells May Offer Lasting Protection Against COVID-19”
Read: scientific commentary by Jay Bhattacharya, Sunetra Gupta, and Martin Kulldorff.
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CDC expanding their scope of legal authority WITHOUT AUTHORIZATION
Posted on August 6, 2021 by Pharmaciststeve
Maybe the pain community can benefit … depending on how this lawsuit shakes out… Our Supreme Court had ruled that ONLY CONGRESS could have the legal right to extend this eviction moratorium…BUT… Pelosi REFUSED to take action….so apparently the CDC decided that they would expand their scope of legal authority and take action…. Just like they did when they issues the CDC opiate dosing guidelines – FIVE YEARS AGO ?
EVICTING BIDEN! Landlord Group Prepares to Sue Over Eviction Moratorium
Landlord groups are suing the Biden administration for extending the pandemic eviction moratorium from the Centers for Disease Control and Prevention, claiming the new order can only be extended by new legislation, as ruled by the U.S. Supreme Court.
The Alabama and Georgia associations of Realtors filed an emergency motion Wednesday night with Judge Dabney Friedrich of the U.S. District Court for the District of Columbia, asking her to enforce the Supreme Court’s recent order stating that the CDC could not extend the moratorium without new legislation.
The Alabama Association of Realtors said the CDC issued the new order “for nakedly political reasons – to ease the political pressure, shift the blame to the courts for ending the moratorium, and use litigation delays to achieve a policy objective.”
“About half of all housing providers are mom-and-pop operators, and without rental income, they cannot pay their own bills or maintain their properties,” NAR President Charlie Oppler, a broker-owner from New Jersey, wrote in a statement. “NAR has always advocated the best solution for all parties was rental assistance paid directly to housing providers to cover the rent and utilities of any vulnerable tenants during the pandemic. No housing provider wants to evict a tenant and considers it only as a last resort.”
Rental assistance is now available in every state to cover up to a year-and-a-half of back and future bills, the NAR noted.
“We should direct our energy toward the swift implementation of rental assistance,” Oppler’s statement continues. “We do not need more uncertainty for tenants or housing providers.”
The Consumer Financial Protection Bureau announced a new online tool where renters and housing providers who continue to face pandemic-related financial hardships can locate and apply for payment assistance for rent, utilities, and other expenses. The new Rental Assistance Finder, at consumerfinance.gov/renthelp, can guide housing providers and renters to aid programs in their area.
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Pharmacies Face Extra Audit Burdens That Threaten Their Existence
Posted on August 6, 2021 by Pharmaciststeve
Pharmacies Face Extra Audit Burdens That Threaten Their Existence
The clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin.
he owner of Newman Family Pharmacy, an independent drugstore in Chesapeake, Virginia, he was responding to an audit ordered by a pharmacy benefit manager, an intermediary company that handles pharmacy payments for health insurance companies. The audit notice had come in January as he was scrambling to become certified to provide covid-19 vaccines, and it had slipped his mind. Then, a month later, a final notice reminded him he needed to get 120 pages of documents supporting some 30 prescription claims scanned and uploaded by the end of the day.
“I was sure I’d be missing pages,” he recalled. “So I was rescanning stuff for the damn file.”
Every page mattered. Pharmacy benefit managers, or PBMs, suspended in-person audits because of covid last year, shifting to virtual audits, much as in-person doctor visits shifted to telehealth. Amid added pandemic pressure, that means pharmacists such as Newman are bearing significantly more workload for the audits. It also has allowed benefit managers to review — and potentially deny — more pharmacy claims than ever before.
According to data from PAAS National, a pharmacy audit assistance service, while the number of pharmacy audits in 2020 declined nearly 14% from the year before, the overall number of prescriptions reviewed went up 40%. That meant pharmacies had to provide more documentation and stood to lose much more money if auditors could find any reason — even minor clerical errors — to deny payments.
The average audit in 2020 cost pharmacies $23,978, 35% more than the annual average over the previous five years, the PAAS data shows. And the number of prescriptions reviewed in September and October was fourfold over what PAAS members had seen in previous years.
Pharmacists have long complained that audits seem to have little to do with rooting out fraud, waste and abuse, but have become a way for these intermediary companies to enrich themselves. According to business analysts at IbisWorld, the pharmacy benefit manager market in the U.S. has grown to nearly $458 billion this year, up from less than $300 billion eight years ago.
Even before the pandemic, independent pharmacies were struggling financially with reimbursement rates they say are too low, the loss of customers to mail-order services or chain pharmacies, and a variety of measures by the benefit managers, including charging pharmacies fees and keeping manufacturer rebates for themselves.
Adding insult to injury: Many independent pharmacies report having received buyout offers from the large drugstore chains that own the PBMs, which pharmacists see as the primary reason for their financial struggles.
At a minimum, pharmacists say, virtual audits increase wait times and drive up costs for customers. At worst, the audits cost pharmacies thousands of dollars in payments for drugs already dispensed to customers, and may ultimately drive them out of business.
“It’s definitely pulling pharmacy staff away from their duties, and it’s become an administrative burden, which does have a direct impact on patient safety,” said Garth Reynolds, executive director of the Illinois Pharmacists Association. “They have to be the de facto audit team for the pharmacy benefit managers.”
Trent Thiede, president of PAAS National, said many of the more than 5,000 pharmacies he works with stepped up to offer covid testing and shots and to become an even bigger resource for customers during this health crisis. “With vaccinations in full swing, priorities should be focused on serving patients and our communities, not responding to audit requests,” Thiede said.
When auditors come in person, they primarily do the review themselves, occasionally asking pharmacists to pull additional documentation.
“In these virtual audits, you have to pull the prescription, put it through a copier of some kind, get everything aggregated, get all the signature logs. They want your license off the wall. They want all the employee licenses faxed,” Thiede said. “It’s a lot more laborious for these pharmacies.”
Express Scripts, one of the nation’s largest benefit managers, moved to virtual audits as a safety measure, said spokesperson Justine Sessions. “The virtual experience is very similar to the in-person audits in both scope and scale, and are conducted with the same frequency,” she wrote in an email. “When it is safe to do so, we intend to resume on-site audits.”
CVS Caremark, a benefit manager affiliated with the CVS pharmacy chain, and OptumRx did not respond to requests for an interview.
Dave Falk, who owns 15 Illinois pharmacies, said the largest audit he had ever seen before the pandemic was for 60 to 70 prescriptions, valued at $30,000 to $40,000. Then, last fall, his pharmacy in Robinson had to defend $200,000 in prescriptions in a virtual audit.
“None of these prescriptions were below $450,” he said. “These audits are not random. It’s a money grab by PBMs.”
He was appalled when the auditor asked his pharmacist to report the temperature of the refrigerator for perishable medications. The information has no bearing on whether prescriptions filled months earlier were appropriate.
“They’re looking for any reason to recoup funds,” Falk said.
After Falk and his pharmacist spent hours providing the documentation, the auditor initially denied $36,000 in drug payments, mostly because of missing patient signatures. Like most pharmacies during the pandemic, Falk’s had stopped collecting patient signatures last year for safety reasons. Major trade associations representing the PBM companies and pharmacies had come to an agreement last year that patients wouldn’t need to sign for medications provided through mail order, delivery or curbside pickup.
Nonetheless, Falk’s staff had to track down dozens of patients to have them sign affidavits that they had received the prescriptions, reducing the auditor’s denial to $12,000.
“That’s $12,000 for ridiculous reasons,” Falk said.
In Newman’s eight years as a pharmacist, he said, he has undergone six audits, all but the most recent done in person. In the virtual one, conducted on behalf of the health insurer Humana, Newman uploaded his documentation before the deadline. But he, too, was flagged for missing signatures.
Dan Strause, president and CEO of Hometown Pharmacy in Madison, Wisconsin, said his pharmacies received more than 1,000 pages of audit requests last year, covering more than $3 million in prescription claims. That represented 1.5% of his company’s total annual revenue. He said pharmacists saw a surge last year of what they call predatory audits, which look for ways to deny legitimate payments for prescriptions.
“What they did in 2020 was reprehensible,” Strause said. “While we were taking care of patients, they’re sitting back in their comfy offices figuring out ‘How can we make money off this? Can we find a loophole? Can we find a missing document? Can we find a reason to take back stuff?’”
Lisa Dimond, a spokesperson for Humana, said the company is required by the government to perform audits to see if pharmacies are adhering to regulations, but conducted fewer audits and reviewed fewer prescriptions in 2020 than in 2019.
“We have worked to reduce as much administrative burden as possible on our network pharmacies, offering extensions, when needed, while still working to ensure pharmacies are filling prescriptions appropriately for the safety of our members,” she said in a statement.
Pharmacists bristle when large pharmacy chains that operate their own benefit managers offer to buy their stores, acknowledging that times are tough. Joe Craft owns the Happy Druggist chain of pharmacies in central Ohio. He said he regularly receives letters seeking to buy his business from the same companies that cause him to lose an average of $6,000 in payments with every audit, about a week’s worth of revenue for a single drugstore.
“When you read that letter, you’re thinking to yourself, ‘Hell, yeah, times are tough,’” he said. “Of all people, they should know.”
And oftentimes, when independents are sold to bigger chains, those drugstores are shut down, and the chain pharmacy directs customers to one of its locations miles away.
Thiede and many pharmacists believe that, while in-person audits may resume after the pandemic, virtual audits may be here to stay as well.
“They can do more because they don’t have to travel and fly across the country and sit in your pharmacy all day long,” Thiede said. “They can just do it from their home and accomplish more.”
PBM’s… demand rebates, discounts, kickbacks from the pharmas to put a particular med on their “approved formulary”… and it all adds up to upwards of 75% of the wholesale price of the medication going to the PBM… which apparently … most goes to their bottom line.
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https://www.freedomwatchusa.org/citizens-grand-jury—-prosecutor-larry-klayman-presents-th
Posted on August 4, 2021 by Pharmaciststeve
What did Shakespeare say ? The first thing we do, let’s kill all the lawyers
Posted on August 4, 2021 by Pharmaciststeve
Filed under: General Problems | Leave a Comment »
When bottom line $$$ determine therapy decisions … expect cheap/poor pt outcomes
Posted on August 4, 2021 by Pharmaciststeve
JAMA Study: Forced Opioid Tapering Harms People. Gee, What a Surprise.
A new study from the Journal of the American Medical Association tells us what anyone with two functioning brain cells already knows: When patients on long-term opioid therapy have their meds tapered, bad things happen. Here are the details.
Just Say No
I personally know a few dozen physicians. Most of them are unaware that the narrative that prescription painkillers are responsible for the so-called “opioid crisis” is false. Perhaps a new article in JAMA will start to change the conversation. It’s long overdue.
In a large, retrospective cohort study, Alicia Agnoli, MD, MPH, MHS, and colleagues from the University of California Davis compared more than 113,000 patients who had been on long-term high-dose opioid therapy and had their dose tapered (1) with patients before or without tapering. The results are both logical and obvious – death and despair.
Subsequent [to CDC 2016] US have advised caution in opioid de-prescribing. Studies suggest risks of suicidal ideation, transition to illicit opioids, and overdose after opioid tapering and discontinuation.
Agnoli et. al., Association of Dose Tapering With Overdose or Mental Health Crisis Among Patients Prescribed Long-term Opioids. JAMA. 2021;326(5):411–419. doi:10.1001/jama.2021.11013.
While a retrospective study cannot determine cause and effect it can still show trends. Based on the large size of the study group and the consistency and magnitude of change in both mental health crises and overdoses these trends are mighty convincing.
Summary of Inclusion/Exclusion Criteria
- An opioid prescription between January 2008 and December 2019
- A mean daily dose of 50 Milligram Morphine Equivalents (MME) for at least 12 months
- At least 14 months of (continuous) medical, pharmacy, and mental coverage
- Patients with cancer or those receiving hospice or palliative care were excluded
The Data
In the absence of tapering, the incidence of overdose was 5.5 events per 100 person-years. With tapering, overdoses were 9.3 “events” per 100 person-years – a 68% higher occurrence. The magnitude of the effect of tapering on patients’ mental health was higher: 7.6 cases of mental health crises per 100 person-years during tapering vs. 3.3 cases in the absence of tapering – an increase of 128%. Mental health crises during tapering were categorized as depression (a 346% increase), anxiety (+79%), and suicide attempts (+430%). (2).
The speed of tapering also impacted overdoses and mental crises, although the absolute magnitude is less. A monthly dose reduction of 10% was associated with an increase in overdoses and mental health issues by 9% and 18%, respectively.
Lessons Not Yet Learned
D]ata provided by the CDC and the National Survey on Drug Use and Health consistently show no association between the number of prescriptions dispensed and the rate of non-medical use of prescription opioids or of opioid use disorder. In other words, opioid deaths are primarily driven by non-medical usage.
ACSH advisor Jeffrey Singer, M.D., Cato Blog, May 24, 2021
Many of my colleagues have been writing for years that the attempt to get a handle on opioid overdose deaths by restricting legitimate medications is a fool’s mission. Yet, the fools are still in charge, at least for now.
And while we’re on the topic of fools, it is the bumbling CDC and the malevolent Physicians for Responsible Opioid Prescribing (PROP) who are the primary culprits in establishing policies that have ultimately forced pain patients to suffer and die. It’s well past time that they get out of the way and let real science and medicine be practiced by competent physicians.
NOTES:
(1) The study does not tell us how many patients tapered voluntarily and how many were forced to do so.
(2) Overdoses and mental health events were determined by emergency department visits or hospital admissions.
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IF you patronize such businesses… it is only your life that you are screwing with
Posted on August 2, 2021 by Pharmaciststeve
I guess that it doesn’t take much to be a war on opiates crisis expert
Posted on July 31, 2021 by Pharmaciststeve
Another person with a platform and visibility that some business trying to make a profit from the fabricated opiate crisis has hitched their wagon to Miss America 2020.
I looked up Virginia Commonwealth University and their PharmD program is a 4 yr program with tuition 32K – 45K/yr (in state, out of state)
Camille Schrier…an incoming second year pharmacy graduate student… meaning that she has finished ONE YEAR toward her 4 yr PharmD degree and she is professing to be a EXPERT on the opiate crisis and medication safety.
According to Wikipedia https://en.wikipedia.org/wiki/Camille_Schrier and As a child, Schrier was diagnosed with a mild form of Ehlers-Danlos Syndrome.[7][8] During the Miss America 2020 competition, Schrier also revealed that she was diagnosed with obsessive-compulsive disorder and recovered from an eating disorder as a teenage
Schrier in public service announcement for National Prescription Drug Take-Back Day, for the Drug Enforcement Administration, 2020
due to the COVID-19 pandemic, the Miss America organization announced that Schrier would serve an additional year after her term as Miss America was due to expire in December 2020
She also apparently has a partnership with Safe Rx
Maybe with those combination of medical issues… she may have had some first hand experience with substance abuse ?
Looks like the DEA and this company Safe Rx… all they need is a pretty woman with high visibility and ONE YEAR towards a PharmD degree to promote her to the public as a EXPERT that they should listen to on our dealing with the fabricate opiate crisis and medication safety
Miss America Is A Pharmacist: How Camille Schrier Advocates For Change In The Opioid Crisis
When you think of Miss America, you probably don’t think of a scientist pursuing her doctorate degree in pharmacy at Virginia Commonwealth University, who speaks about the opioid epidemic and medication safety. Conversely, when you think of a pharmacist, you probably don’t think of a woman in heels and makeup, who enjoys fashion, just as much as science.
But, that is just who you get when you meet Camille Schrier, Miss America 2020 and an incoming second year pharmacy graduate student. In representing the balance of the two, and educating people about both roles, she has been able to break down many different stereotypes. She calls herself a “science princess” and perhaps this is best showcased by her unique talent from competition. She did a science experiment. Though the idea was to display her skills and talents, and the experiment itself came from YouTube, to Camille it really represents, “just being yourself in every situation.”
Perhaps that attitude has allowed her to use her time as Miss America to compliment her education and future career in pharmacy in unexpected ways. Chief among them is using her advocacy platform for her social impact initiative, “Mind Your Meds,” which has a strong focus on combating the opioid epidemic. In other words, she used her newfound megaphone to try to make larger changes in her future field.
She explains, “One of the things that I started to really recognize in my role is how much pharmaceutical products can be misused in a way that leads to overdoses and substance use disorder, and that it’s more than just, you know, someone deciding to pick up an illicit drugs out of the blue, and become addicted to that substance…Once I became a pharmacy student, I started to understand how…substances that people have found to be so beneficial, can also be dangerous for some people.”
Camille on stage speaking about her social impact initiative, “Mind Your Meds,” which has a strong … [+]
Miss America Organization
Miss America also led her to new partnerships, like hers with Safe Rx, a company fighting America’s opioid epidemic with its locking pill bottles, to help with medication safety in the home and safe storage. The locking pill bottles are kind of like safety locks on guns, or seatbelts in cars, and actually help put safety controls on medications via a combination lock.
Camille holds SafeRx prescription bottles that help put safety controls on medication via a … [+]
Camille Schrier
Doing so prevents kids, for example, who are home right now from accessing them, especially unsupervised. Camille feels having a possible solution allows her to take a step beyond educating people about risks, and provides people with actionable steps. She can focus on prevention, which she believes increases her power as an advocate.
Prevention is one key for change, as is actually talking about the epidemic out loud. This is sorely needed particularly right now as deaths in the United States due to drug overdoses are at an all time high. In fact, recent Centers for Disease Control and Prevention (CDC) data, show that more than 93,000 people died from overdose in the last year, an increase of nearly 30% from 2019. Yet, if you turn on the television, the media rarely discusses it.
Camille says, “The thing that really kind of breaks my heart is when I watch T.V. during Covid-19 and I hear about the Covid-19 death numbers, and I hear about the vaccines that are being quickly developed to be able to overcome this pandemic. There’s a silent epidemic of addiction and substance use disorder that happens in our country, and has been continuing to happen for 10, 15, 20 years and has never gotten the type of publicity or action that Covid-19 has because of the stigma associated with it.”
She points out that this remains true even as the numbers have increased and the conversation has become even more critical. However, the media silence has only increased her desire to be an advocate for change and to become a pharmacist.
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