Pharmacies Face Extra Audit Burdens That Threaten Their Existence

Pharmacies Face Extra Audit Burdens That Threaten Their Existence

https://khn.org/news/article/rural-pharmacies-audit-burdens-threaten-their-existence-the-last-drugstore/

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.

 

https://www.freedomwatchusa.org/citizens-grand-jury—-prosecutor-larry-klayman-presents-th

 

What did Shakespeare say ? The first thing we do, let’s kill all the lawyers

When bottom line $$$ determine therapy decisions … expect cheap/poor pt outcomes

JAMA Study: Forced Opioid Tapering Harms People. Gee, What a Surprise.

https://www.acsh.org/news/2021/08/03/jama-study-forced-opioid-tapering-harms-people-gee-what-surprise-15712

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.

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. 

IF you patronize such businesses… it is only your life that you are screwing with

https://i.redd.it/1xpdmpbp5ue71.jpg

I guess that it doesn’t take much to be a war on opiates crisis expert

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

https://www.forbes.com/sites/jessicagold/2021/07/30/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.”

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.

 

 

 

 

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.

 

Could self insured employers become a chronic pain pt’s ally ?

Many employees that work for large companies may or may not be aware that their health insurance is provided by their employer on a self-insured basis, this is referred to as a ERISA prgm. It is claimed that about 50% of large employers are self-insured.  The employee is presented with a “health insurance card” and or a “Prescription drug card”  What the employee may or may not understand is that the well recognized name on their health insurance card is NOT AN INSURANCE but acting as an administrator for the employee to pay the medical expenses that is incurred by the employees and their families.  The “insurance company” has no real financial liability… they could be working on an administrative fee of so many $$$/employee/family and/or some percent of what is paid out as a administrative fee.

The insurance company will generally win the business from the employer with some “dog and pony show” … promising to help the employer lower overall health expenditures for the company. What the employer may not realize that saving money will mean coercing employees to use their mail order pharmacy, step therapy where the pt has to fail on the least costly med before they can “try” the next high cost med and sometimes any improvement is where the next step in the therapy is allowed to be tried… any improvement in QOL … is sufficient.

Also,what many employees don’t understand that there is someone within the company that has the authority to call the insurance/PBM company and tell them to pay for any med or procedure, because it is the employer’s money that is being spent.

Hypothetical,  an employee’s spouse is a chronic pain pt.  The insurance/PBM approached the employer to implement a opiate dosage reduction program… help prevent addiction among employees and/or family members.  So the insurance/PBM implements the CDC opiate dosing guidelines and puts a max MME/day at 90 MME’s. One or more of the employees or their spouses are fast/ultra fast metabolizers and dealing with CRPS… meaning that they are going to need high single doses and very frequent dosing per 24 hrs to help maintain their QOL.  These pts have been stable on very high doses for several years or a couple of decades… and their dose is slowly – or very quickly – reduced  and the pt starts becoming chair/bed/house confined..

Using the chart belong the employee goes to the person that oversees ERISA program.  Need to point out to this insurance/pbm point person… the number of very possible compromising the existing comorbidity issues and/or creates new comorbidity issues… One example is that under/untreated pain… will cause the pt’s system to keep pumping out adrenaline … which will mean that the pt’s adrenal glands will eventually fail and the pt will end up with Addison’s disease.

Here is a post on how liver damage can be for a pt who is taking Tylenol/Acetaminophen  https://www.pharmaciststeve.com/liver-injury-from-acetaminophen-at-low-doses-linked-to-fasting-heavy-drinking/   I can hear the first comment … my spouse doesn’t drink… great… but what happens when the pt goes into a flair and ends up in bed or on the living room couch for a few days..  DOESN’T EAT MUCH – like FASTING ?… they continue to take their Tylenol/Acetaminophen and ends up with liver damage.

Point out to the insurance/pbm contact person… things like their spouse could end up hypertension, resulting in eye and/or kidney damage. Could suffer a hypertensive crisis and end up with a paralyzing stroke and/or death…

The pt being forced to take NSAID and/or Tylenol/Acetaminophen… 15,000 people die every year from gastro bleeds from use/abuse of NSAID

The pt could end up with increased anxiety and/or depression

All of these issues – except death – is going to cost the employer money… paying for increase medical/hospital expenses because the insurance/PBM got the employer to let them introduce a opiate reduction program to help to keep employees and their family members from becoming addicted to opiates.

The number of possible complicated health issues for the chronic pain pt that has their opiate therapy reduced/eliminated.

Give the insurance/pbm contact person this chart and let them assign a $$$ figure to each of the possible health complications for their spouse and/or how many other spouses of employees could be impact in a equal or similar manner…  I suspect that the potential costs to the employer is MUCH … MUCH greater that the cost of paying for rehab for anyone who might become addicted and seeks treatment.

There is very seldom a situation when a MIDDLEMAN comes into a process that can cut overall costs of a program. Middlemen have a cost overhead and a desire to show a profit. It is more likely that middlemen will increase overall costs of a process.

 

“BODY COUNT” from COVID-19 is pretty fungible

Cannabis/drug interaction database

https://www.drugs.com/interactions-check.php?drug_list=2758-0,531-0

 

Untied Nations: Genocide is a CRIME under International Law – which they undertake to prevent and punish