By NBPAS, August 10, 2021.

A recent article in the American Journal of Managed Care shed light on copay maximizer strategies among generics manufacturers. But not many patients understand how drug manufacturers are incorporating copay maximizers and accumulators in their reimbursement strategies.

As a widespread challenge for patient access, copay accumulators and maximizers eliminate the altruistic nature of the patient assistance programs. Companies implement these programs to spread out cost-savings for patients over a longer period of time. This leads to the drug manufacturers mitigating cost-sharing burden. Now, the patient is responsible for their deductibles and copays. With an estimated rise in copay maximizers, patients experiencing accumulators may see higher copays.

During the next decade, the industry is expected to expand copay accumulators and maximizer programs. As a result, patients may opt to abandon their therapy when their medication becomes too costly. However, even though copay maximizers distribute the financial responsibility over each month of the year, one potential outcome is that patients may find their health care costs too expensive to continue their treatment.

Recently, the American Society of Clinical Oncology (ASCO) issued a statement opposing copay accumulator and maximizer programs to safeguard patients’ access to care.

Yet, despite this opposition, the Centers for Medicare and Medicaid Services (CMS) announced in their Notice of Benefit and Payment Parameters for 2021 that insurance plans may use these programs starting in 2023. Currently, patients enrolled in federal health programs cannot participate in copay assistance plans. So, while this ruling increases the patient access to copay assistance, implementation of the accumulators and maximizers may not offer enough of a benefit for most patients.

Ed. – From Truveris.com:

Recently, several states have passed legislation that prohibits the use of copay accumulator adjustment programs (CAAP), or accumulator adjustment programs. These programs seek to reverse the impact of manufacturer cost-sharing assistance for prescription drugs (primarily specialty drugs) by not counting the manufacturer assistance amount towards a patient’s deductible and out-of-pocket (OOP) maximum obligations. Copay accumulator programs in effect extend the amount of time it takes for a patient to reach his/her deductible and OOP limit, thereby reducing the plan sponsor’s coverage until such cost-sharing is met. The annual cost impact to the payer with such programs (self-funded plan, insurer) varies depending on the plan size and mix of medications eligible for copay assistance.

As of July 2021, Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, West Virginia, and Puerto Rico have enacted legislation prohibiting copay accumulator programs. Similar legislation is currently pending in several other states. These regulations generally apply to fully-insured plans as well as self-funded plans that are NOT subject to ERISA. Effective dates for compliance with these new laws varies, ranging from July 1, 2021 (Tennessee), to January 1, 2022.

> Double-dipping: Read More from the Aids Institute (pdf)

> Buy drugs at the lowest cost at Mark Cuban’s online drug store

A patch containing the active ingredient fentanyl is shown by a pharmacist. The painkiller fentanyl, which can be up to 100 times stronger than heroin, is a growing cause of overdose deaths in the U.S., according to the DEA.

In its first public safety alert in six years, the Drug Enforcement Administration is warning about a dramatic increase in fake prescription drugs being sold on the black market containing a potentially lethal dose of fentanyl.

The DEA said the counterfeit pills — made to look like real opioid medications such as oxycodone, Percocet or Adderall — are sold on the street by dealers or online, including through social media platforms.

“If you have a smartphone and you’re sitting on the sofa at home … your drug dealer is right there in your hands,” DEA spokesperson Anne Edgecomb said in an interview with NPR.

The agency said it has seized more than 9.5 million fake pills so far this year, more than the last two years combined. It said its lab has found that two out of every five fake pills with fentanyl contain a potentially lethal dose of the drug.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said. “Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before.”

The last time the agency issued such a public safety alert was in 2015 when it warned of a sharp increase on the street of fentanyl-laced heroin.

The latest warning comes amid an ongoing epidemic of drug overdoses in the United States. The Centers for Disease Control and Prevention estimates that more than 93,000 Americans died from a drug overdose last year — more than ever before.

“Fentanyl, the synthetic opioid most commonly found in counterfeit pills, is the primary driver of this alarming increase in overdose deaths,” the DEA said.

This alert doesn’t only apply to fake opioid medications. DEA officials said a knockoff version of the stimulant Adderall is being sold on the black market laced with methamphetamines.

The alert issued Monday doesn’t apply to legally prescribed and dispensed legitimate pharmaceutical medications, the DEA said.

By Laura Sydell, The Washington Post, June 05, 2021.

Patricia Limbaugh was desperate to find care for her husband, whose drinking had spiraled out of control after the death of one brother by suicide, another from a heart attack, and a lot of stress at work. They had tried a rehabilitation program recommended by a hospital near their home just outside Nashville, but neither of them was happy because the facility refused to let them communicate. “That’s when I started Googling alcohol treatment centers,” said Limbaugh, “cause I thought I’ve got to get him out of this place and get him somewhere else.”

Limbaugh’s search in the early spring of 2019 brought her to an addiction treatment facility called The Center, A Place of Hope in Edmonds, Wash. The facility had glowing reviews on Google like this one from a Jeremy Maria: “I don’t know if I have words enough to truly express my gratitude to each and every member of my team.” Another review by Devin Lindsey cited specific staff members: “I’ve had lightbulb moments with Justin Hartfield, Lisa Chinn, and Lynsey Isaacs and all have been helpful in my improvement of self-worth, skills and tools to take with me.”

Limbaugh and her husband flew to Washington state, and he checked in on April 11, 2019. But after he got home from the 30-day treatment regime, her husband confessed he drank while he was there. “The housing was off-site from the facility,” Limbaugh said. At the end of each day, she said, “he would go and have a nice meal, a couple of glasses of wine and, or he’d get a bottle. And so, he drank the whole time he was there.”

The Washington Post asked The Center about each of Limbaugh’s claims. In an email, Tom Lether, an attorney for The Center, would not respond specifically to her charges, saying only: “The Center strongly disagrees with these allegations.”

Limbaugh said she felt taken in by the reviews. “I felt deceived,” she said.

It turns out that the reviews she relied on from Maria and Lindsey — and dozens of others on The Center’s site — were fake, according to separate analyses conducted by Google and the review site Trustpilot after they were approached by The Post.

Fake Review Watch, a consumer watchdog site founded by former fraud investigator Kay Dean, had initially discovered the fake reviews and shared them with The Post. The Post then shared the reviews with Google and Trustpilot.

Although Limbaugh thought she could trust the reviews on a health-care provider’s site, she had stumbled upon a problem created by a convergence of forces: a public that has come to rely on consumer reviews for almost everything including medical care; a robust industry of global review fraud; competition among physicians; large Internet companies with minimal incentive to weed out that fraud; scattershot disciplinary actions by professional medical bodies; and lax enforcement by government agencies.

When asked about potentially fraudulent activity on The Center, a Place of Hope’s Google page, Google took down 93 reviews, including the ones by Maria and Lindsey.

Google’s algorithms and staff use indicators such as the location of the reviewer to assess whether a posting is from a real patient. Ben Jose, a Google spokesman, said the company “removed reviews that were found to be in violation of our policies.” The Center still has a 4.5-star rating, and Google did not put up a notice that it had taken down suspicious postings.

The Post also contacted the review sites Yelp and Trustpilot about potentially fake reviews of The Center. Yelp said its automated processes had previously “unrecommended” 40 reviews, which makes them less visible and prevents them from counting toward The Center’s overall rating. Trustpilot took down 73 posts it determined were fraudulent — about half of The Center’s reviews at the time.

Wahid Lodin, a spokesman for Trustpilot, said the company weeds out fraud through “tracing IP addresses, researching a user’s post cadence, analyzing the word usage in their review.” Trustpilot put an alert on The Center’s page, saying that it had detected “a number of fake reviews for this company.”

Fake Review Watch’s Dean said she has found dozens of Facebook groups where businesses including medical practices buy and sell fake reviews. Inside one of these groups, the watchdog said it found a Bangladeshi review broker who recruited people to write fake positive reviews for The Center.

In a video, Fake Review Watch documented what it said was an exchange in which the broker gave the paid recruits the exact text that would later appear as reviews written by Maria and Lindsey. At least two of the employees mentioned in Lindsey’s review appeared to have a connection with The Center. One listed The Center on a LinkedIn page; another used the center’s telephone number and address on a health site.

The Post cannot confirm who paid to put the fake positive reviews on The Center’s site.

Lether said The Center and the facility’s founder, Gregory Jantz, never paid anyone to write fake reviews and took measures to ensure that reviews were accurate.

“Dr. Jantz indicates the Center has been investigating malicious online attacks through spamming, bot attacks, obvious fake reviews and social media manipulation,” Leather wrote in an email.

“The Center receives numerous testimonials and postings. The Center exercises due diligence to make sure that postings or online information is correct and accurate. To the extent The Center identifies any inaccurate postings or information, the Center will remove The Post immediately.”

Google did not respond when asked if The Center has tried to get fake reviews taken down. Trustpilot says it never heard from anyone at the facility that there might be fraud on its page. “We never heard from them regarding that,” Lodin said.

Dean said she has identified fake reviews for dozens of other medical practices including two separate practices in California, a rheumatologist and a pain clinic, both involving the same review broker as The Center.

Posting fraudulent reviews may be illegal under federal and state laws if there is financial gain involved. But enforcement is scattershot, and it is hard to find cases of disciplinary action from professional bodies for review fraud. Records from the Medical Board of California, the state with the largest number of practicing physicians, show no actions taken against doctors over the past four years for fake reviews.

“When the board receives a complaint against a physician or allied health-care professional it oversees, the complaint is investigated,” board spokesman Carlos Villatoro said. The board does not discuss ongoing investigations.

New York state has the second-highest number of practicing physicians, and neither the Office of the New York State Attorney General nor the Office of Professional Medical Conduct could cite a case that had been brought against an individual medical doctor for manufacturing fraudulent reviews.

The New York attorney general’s office did point to a case against an urgent care center that purchased fake reviews, but there was no indication that individual doctors were involved. Medrite Urgent Care faced a $100,000 fine and agreed to measures to increase the honesty and transparency of its reviews.

Michael Atleson, an attorney at the Federal Trade Commission, could not recall an instance over the past two decades where the agency filed an action against an individual physician for fake online reviews. But he cautioned that “the FTC does not confirm nor deny the existence of investigations or comment on investigations, even if they have been publicly disclosed.”

Although there is no easy way to quantify how many physicians and health-care providers are faking reviews, Curtis Boyd, the CEO and founder of Objection Co., which specializes in identifying fake local business reviews for business owners, estimated that as many as 20 percent of businesses in the health-care industry including doctors have suspicious review activity on Google and Yelp.

Boyd said he based his estimate on work he did for sites like Upwork, Fiverr and Amazon’s Mechanical Turk, where freelancers look for work. There, he said, he found a shady marketplace of brokers looking to hire people to write positive reviews for their customers — including medical doctors. Boyd said he persuaded 35 of those brokers to sell him their client list, which he used to train his algorithms to identify fake reviews.

Using artificial intelligence, Boyd was able to detect details that were likely to signify that a review was fake. “Exclamation points was one of the most obvious ones, like excessive use of exclamation points,” he said. “We also saw a lot of sentiment, over-the-top sentiment like the word ‘love.’ And it was kind of interesting to see over-the-top sentiment. We think that it has to do with, like, a compensation of a lack of actual experience.”

He said certain types of physicians were more likely to have fake reviews. “Physicians with their own personal private practices tend to have more suspicious reviews,” he said, “versus physicians who might be an employee of a large medical center or a hospital.”

Marni Jameson Carey, executive director of the Association of Independent Doctors (AID), a national nonprofit trade group for physicians in private practice, condemns physicians who post fake reviews. However, Carey said that she can imagine how some independent medical doctors might feel desperate to boost their online reputation to compete against large hospitals that are buying up independent medical practices.

“Employed physicians have entire marketing departments behind them,” she said. “It is certainly hard to survive as an independent. There’s a sense of guerrilla warfare out there.” Carey said the association has not caught any physicians posting fake reviews. “If we ever do encounter this issue, we will have to decide how to confront it and the physician at that time,” she said.

In a statement, American Medical Association President Susan R. Bailey said that “the credibility of some rating sites is questionable.” Bailey suggests “online opinions and reviews of physicians should be taken with a grain of salt and should certainly not be a patient’s sole or primary source of information when looking for a physician.”

However, patients are increasingly using review sites to find doctors, according to a study by Software Advice, a consulting firm. According to a 2020 survey, over 70 percent of patients use online reviews as the first step to finding a new doctor. That’s up from a similar survey in 2013 that found that only 25 percent of patients used online reviews to find a physician.

In our review-crazed age, patients appear more likely to trust user review sites such as Yelp and Google over government sites about physicians, according to a 2018 study by the Brookings Institution, which looked at how patients choose health-care providers. The study’s participants repeatedly favored a physician’s five-star rating on Yelp over a one- or two-star rating from the government.

“The reason that physicians are paying for these fake reviews is that they know the importance of how it will drive patients to their office,” said Niam Yaraghi, an assistant professor of business technology at Miami Herbert School of Business at the University of Miami who conducted the study.

Sites like Zocdoc, which charge physicians for appointment bookings, allow only patients who have booked appointments with a doctor to leave reviews. However, Laura C. Mikulski, vice president of business development and physician relations at Physician Referral Marketing, said patients may be reluctant to leave bad reviews for fear of exposing themselves to a lawsuit from their provider. “If I am a patient,” Mikulski said, “and I have a negative experience with my physician, I don’t want my physician to try to sue me or to try to terminate services.”

Jessica Aptman, a spokeswoman for Zocdoc, said that “although providers are our paying customers, our company’s number one core value is Patients First, and our mission is to give power to the patients.” Zocdoc also allows anonymous reviews, though the company does have records of who the reviewers are.

Many physicians would prefer to be taken off all of these review sites. Physicians Working Together organized a Change.org petition to remove medical doctors from Yelp. Founder Kimberly Jackson, who practices family medicine in Phenix City, Ala., said that medical doctors find themselves in a bind. If a patient writes a negative review, a doctor can’t give a full-throated defense because of HIPAA privacy regulations. “You’re not supposed to be sharing patients’ confidential health information,” Jackson said. “In a lot of cases, we don’t even want to acknowledge that you’re a patient.”

In addition, Jackson argues that patients aren’t always the best judge of quality medical care. “Sometimes people have their own agendas,” she said. “I’ve experienced that myself, there was a Google review, or a person said that, you know, the office is horrible. The receptionist was so rude, and I never made an appointment with this doctor. But they still went ahead and reviewed, like, my bedside manner and my medical knowledge and whatever.”

A study late last year in the peer-reviewed quarterly journal Information Systems Research underscores her point. It tracked 10 years of data from Northern Texas hospital patients struggling with chronic diseases. They compared outcomes for these patients with the reviews given to the doctors they saw. The study measured factors such as readmission risk and other broadly accepted measures of clinical outcomes. It found star ratings and written reviews equally bad at judging the quality of medical care.

Another study, in the Journal of the American Board of Family Medicine in 2018, found that patients gave doctors who overprescribed opioids higher ratings.

Some people may think they can tell which reviews are real and which are fake. But “humans are notoriously terrible at determining whether a review is fake,” said Zachary Pardes, director of brand advertising and communications for North America at Trustpilot. He said many people wrongly think they can spot a fake review by looking for grammatical errors and poor syntax or through a profile picture. But the algorithms used by his company to find fakes are also imperfect, he admits.

“I think it is a volume, it’s a scale problem,” he said. “We are in this constant game of cat and mouse.”

Google, which is quickly becoming the biggest player when it comes to consumer reviews, said it is getting millions of new postings a day. Although Google might not catch all the fakery, Jose, the Google spokesman, says, “We continually invest to improve our automated systems to better detect fake reviews while also deploying analysts who investigate suspicious content around-the-clock.”

But when dealing with hundreds of millions of reviews, even a fraction of missed fraud can have a significant effect, said Mike Blumenthal, co-founder of Nearmedia, a research company that focuses on local businesses and the Internet. “The problem with artificial intelligence, machine learning, is that it’s a statistical approach,” he said.

Blumenthal argues that the companies don’t have sufficient incentive to catch it all. “To capture the rest would require human curation,” he said. “They’re not willing to spend the money it would take to more effectively manage that part of the fake reviews they miss with their algorithms.”

Blumenthal also points out that platforms face no penalties when they do miss fraud. Federal law protects these companies from liability. Under Section 230 of the Communications Decency Act, Google, Yelp, Trustpilot and other platforms are generally insulated from legal liability for fraudulent content posted by third parties on their sites.

When asked about Blumenthal’s criticism, Google directed The Post to prepared remarks by its CEO, Sundar Pichai, at a congressional committee hearing in March about misinformation and extremism on tech platforms, defending Section 230. “Without Section 230, platforms would either over-filter content or not be able to filter content at all.”

Blumenthal finds the fake reviews on medical websites especially troubling. “When it comes to a restaurant, the worst that can happen is you will get a bad meal,” he said. “But with a physician, the stakes of bad medical care can be higher.”

And in the absence of reliable and easily accessible information about doctor performance, most patients are going to continue to resort to online reviews, Yaraghi, the Miami professor, said.

“Patients are not well-informed about this, and they are unfortunately taking these reviews more seriously than they should,” he said. “The reason these online reviews are becoming more important is because there is a vacuum.”

Article link: https://www.washingtonpost.com/business/2021/06/04/fake-medical-reviews-google-zocdoc-trustpilot/

By Steve Cohen, STAT, Mar 11, 2021.

The news Jennifer G. and her husband got from her medical team was devastating.

If you had come to us a month sooner, they said, we would have used chemotherapy to treat your cancer. But because of the delay, we have to amputate your leg, your hip, and your pelvis.

The delay they referred to wasn’t due to any negligence on the part of the 46-year-old mother or the doctor treating her. Instead, the 38-day delay was caused by her insurance company, which had denied her orthopedist’s request for an MRI of Jennifer’s hip, deeming it “not medically necessary.”

Jennifer (not her real name) had initially sought care for pain in her leg and hip some three months before, and had completed a doctor-prescribed course of six weeks of physical therapy. But the pain continued. Her insurance company — and its utilization review contractor, the company it relied on to assess medical necessity — deemed the MRI “not medically necessary” until Jennifer had completed six weeks of physical therapy and over-the-counter painkillers.

In the process of trying to secure authorization for the MRI, the orthopedist pointed out that not only had Jennifer already completed the required course of physical therapy, but that the insurance company had even paid for it.

The insurance company’s response to Jennifer’s doctor was “You need to appeal the denial.”

Although the doctor immediately filed an appeal, trivial demands and bureaucratic delays ate up 38 days before the insurer reversed its denial. And in those 38 days, according to both Jennifer’s treating doctors and a consulting expert witness, a fast-growing cancer had spread, making those massive amputations necessary. (I know these details because my law firm represents Jennifer’s estate in a lawsuit against the insurer and its utilization review company.)

Two years after that 38-day delay in her diagnosis and treatment, Jennifer, maimed and in pain, died.

Just months before Jennifer’s ordeal, the same utilization review company denied a New Hampshire woman an MRI. While she thankfully did not die, her delay resulted in her having to use a wheelchair for the rest of her life.

Rather than being the exception, denials and delays by insurance companies are often the norm. The American Medical Association has been surveying doctors about prior authorization reviews for several years. Their impact is not good: 83% of doctors report that prior authorization requirements harm the continuity of care and 86% report that the problem has gotten worse over the last five years.

The rationale for insurers requiring prior authorization and engaging in utilization reviews seems legitimate — at least at first glance — because there is waste and fraud in the health care system. With some $3.8 trillion dollars, almost 18% of the nation’s gross domestic product, being spent on health care each year, the temptation for wrong-doers is substantial. Insurance industry and law enforcement estimates of health care fraud range between 3% and 10% of that $3.5 trillion — at the high end, that’s about $350 billion annually.

The administrative cost of rooting out this waste and fraud is even higher than the fraud itself. The Center for American Progress estimates that billing and insurance-related costs to be $496 billion annually, and the National Academy of Medicine estimated that these costs are twice as high as they need to be. Doctors estimate that they and staff members spend two full business days a week dealing with prior authorization bureaucracy.

For insurers, the administrative hoops they demand doctors jump through make perfect sense — at least economically. Doctors report that 20% of patients always or often abandon the treatment their doctors have recommended while awaiting authorization, and another 55% sometimes do. When patients don’t get the prescribed test or treatment, that saves the insurer money.

Sometimes there is no real harm: conditions resolve themselves, pain abates, and patients recover. But all too often there are serious complications: 24% of doctors report that delays in prior authorization have led to serious adverse events for patients in their care, and fully 16% report that such delays have led to a patient’s hospitalization.

Tellingly, insurance companies have provided scant evidence that their utilization reviews and demands for prior authorization have actually helped root out fraud or waste. The industry’s trade group, brilliantly named the National Health Care Anti-Fraud Association, does a capable job of recounting the hypothetical estimates of fraud and citing appalling stories of crooked providers illegally reaping millions from scams.

Insurers’ rationale for prior authorization is simple: It bolsters the bottom line. Tellingly, it is a reversal of their longtime practice of “pay-and-chase.” Once upon a time, insurers would pay medical claims upfront and then use their investigators to attempt to recover payments believed made in error or as the result of fraud. By shifting the burden to doctors and patients, payments to providers are reduced and delayed.

Yet the old pay-and-chase is precisely the procedure that should be followed — with a well-proven twist. Insurers should not have carte blanche to require prior authorization for routine procedures or medications, but they should be able to reap substantial awards when they do uncover fraud. The nearly 160-year-old False Claims Act (also known as Lincoln’s Law) assesses treble damages against fraudsters and gives incentives to whistleblowers to share in such recoveries. Significantly, this arrangement results in the federal government recovering more than $2.6 billion annually just from health care scams. Congress should extend the formula to all health care fraud, not just federally-funded procedures.

The current system of prior authorization harms too many patients, erodes the doctor-patient relationship, and uncovers too little fraud while bolstering an insurer’s bottom line. It is time to flip the model in favor of patients such as Jennifer G.

Link to the Original Article

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By Ellen Gabler, The New York Times, Jul 16, 2020.

In a rare public rebuke of the nation’s largest retail pharmacy chain, state regulators in Oklahoma cited and fined CVS for conditions found at four of its pharmacies, including inadequate staffing and errors made in filling prescriptions.

While the fine of $125,000 on Wednesday was small for CVS Health — it paid its chief executive $36.5 million in total compensation last year and is the country’s fifth-largest company — the move validated concerns raised at multiple drugstore chains across the country by pharmacists and technicians who say understaffed workplaces are putting the public at risk.

CVS also agreed to distribute a memo to its pharmacists in the state, highlighting a law that requires them to take action if working conditions in their pharmacies could lead to problems safely filling prescriptions. The memo is to make clear that they are not to face retaliation for documenting and reporting such issues.

In a statement, a CVS spokesman said the company agreed to the terms to “avoid the time and expense of a protracted hearing process and to foster a positive working relationship” with the Oklahoma State Board of Pharmacy. The spokesman said the action did not constitute an admission of guilt by the company on all counts.

The state board inspected the four pharmacies from mid-2019 to early this year after receiving multiple complaints about errors and overwhelmed staff members.

One of those errors occurred last year when a developmentally disabled teenager received one-fourth of his prescribed dose of anticonvulsant medication from a CVS in Owasso, a suburb north of Tulsa, according to a complaint filed by the board. The boy took the incorrect dosage for 18 days, during which his seizures became uncontrollable, causing him to fall and hit his head, said his father, Aron Brown.

The convulsions were “nonstop” and “violent,” Mr. Brown said. “You have no idea what kind of shame we feel about this — that we couldn’t figure out what was going on.”

As part of its agreement on Wednesday, CVS will pay a $75,000 fine for that incident — the highest amount allowed under state law for this case — and its Owasso pharmacy will remain on probation for two years. While pleased the board had addressed the matter, the boy’s parents said they were worried that the action was not strong enough, and that it could allow other patients to be harmed in the future unless CVS made substantial changes to its business.

“A $75,000 fine? That is nothing to them,” said the teenager’s mother, Rachel Banning. “These things are going to keep happening if they don’t fix their staffing issues.”

Pharmacists in dozens of states have accused CVS, Walgreens and other major pharmacy chains of putting the public at risk of medication errors because of poorly staffed and chaotic workplaces, The New York Times reported in January.

In letters to state pharmacy boards and in interviews with The Times, pharmacists said they struggled to keep up with an increasing number of tasks — filling prescriptions, giving flu shots, tending the drive-through, answering phones and calling patients — while racing to meet corporate performance metrics they characterized as excessive and unsafe.

The pharmacy chains, including CVS, have pushed back on employees’ complaints, saying staffing is sufficient and errors are rare.

Most state investigations focus on pharmacists, not conditions in their workplaces. In Oklahoma, the state board has begun investigating broader workplace issues when responding to complaints and doing routine inspections.

In mid-January, two board compliance officers went to a CVS in Bartlesville, Okla., to investigate a complaint of a mislabeled prescription. There, they “witnessed a chaotic scene including the phones ringing almost all of the time, along with constant foot traffic and drive thru traffic,” according to a complaint filed against CVS.

The officers discussed the error with the head pharmacist, noting that she said “she had lost a considerable amount of her support staff, and that the pharmacy was operating with little help, so she was not terribly surprised that an error could have occurred.”

In an audit, the officers found an error rate of nearly 22 percent, or 66 errors out of 305 prescriptions. Some of the mistakes were minor and would not affect a patient — such as the incorrect name of a prescribing physician — but others were more significant, like instructions for medications that were unclear or substantially different from what they should have been.

Days later, a prescriber complained of insufficient staffing at a pharmacy in Moore, about 10 miles south of Oklahoma City, saying calls were placed on hold for up to 60 minutes. Compliance officers reported finding one pharmacist and one technician who had fallen behind on work.

The officers recorded a 6 percent error rate, according to the complaint. Some of the errors were substantial, including the wrong dose of an antibiotic for a 1-year-old, the incorrect frequency for an antiviral drug (every two hours instead of 12) and multiple errors involving the frequency of a narcotic.

There were several reported errors involving testosterone; in one case, the dose was doubled for a female patient. The compliance officers also noted mistakes related to blood pressure, gastric disorder and steroid medications that had been dispensed to or entered for the wrong patients.

Errors were also flagged in a complaint about a pharmacy in Choctaw, east of Oklahoma City, in February. Inspectors said a computer screen showed more than 99 prescriptions waiting to be filled and more than 99 calls needing to be made.

When asked about the backlog, the pharmacist said that employees were several days to weeks behind, according to the complaint, adding that they had been given an extra 17 hours of technician help but could not find anyone who would work only 17 hours.

Similar staffing concerns were detailed in the case involving the disabled teenager. The pharmacist on duty that day, according to the complaint, was responsible for checking 194 prescriptions in a six-hour shift, about one every two minutes.

The store’s lead pharmacist told the board that he had no control over staffing, and that while he complained about the issue to his district leader, she also had no power to make changes.

That district leader, Amanda Dixon, who is a pharmacist, told The Times in an interview this week that “district leaders were repeatedly voicing their concerns about the budgets” for staffing at CVS pharmacies last year.

Dr. Dixon said that many pharmacies in her 19 stores were short-staffed, that customer complaints were on the rise and that she was worried about patient safety. She had worked for CVS for almost six years until November, when, she said, she was terminated for a policy violation involving another employee, although she believes she may have been retaliated against by the company because of the board’s investigation.

In its statement on Wednesday, Michael DeAngelis, the CVS spokesman, said that “if a pharmacist has a legitimate concern about working conditions, we make every effort to address that concern in good faith.” He added that any suggestion the company retaliated against a district leader was false.

In addition to the fines, the state board said it “strongly recommended” that the company follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined.

The board also advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. Phone calls pharmacists often must make, it said, could be outsourced to a corporate call center.

Mr. DeAngelis said the company would review the board’s recommendations, noting that CVS had reduced its overall metrics this year and was planning to increase staffing in the fall to help handle vaccines for flu season.

Article link: https://www.nytimes.com/2020/07/16/business/cvs-pharmacies-oklahoma.html

Unbeknown to most patients, their race is incorporated into numerous medical decision-making tools and formulas that doctors consult to decide treatment for a range of conditions and services, including heart disease, cancer and maternity care, according to a new paper published Wednesday in the New England Journal of Medicine.

The unintended result, the paper concludes, has been to direct medical resources away from black patients and to deny some black patients treatment options available to white patients.

The tools are often digital calculators on websites of medical organizations or — in the case of assessing kidney function — actually built into the tools commercial labs use to calculate normal values of blood tests. They assess risk and potential outcomes based on formulas derived from population studies and modeling that looked for variables associated with different outcomes.

“These tests are woven into the fabric of medicine,” said Dr. David Jones, the paper’s senior author, a Harvard historian who also teaches ethics to medical students.

“Despite mounting evidence that race is not a reliable proxy for genetic difference, the belief that it is has become embedded, sometimes insidiously, within medical practice,” he wrote.

The paper is being published at a tense moment in American society as black communities, disproportionately affected by the coronavirus, protest unequal treatment in other areas of their lives.

Dr. Jones said he believed the developers of the tools, who often are academic researchers, are motivated by empiricism, not racism. But the results, his analysis found, have often led to black patients being steered away from treatments or procedures that white patients received.

The paper included a chart listing nine areas of medicine where there are race-based tests, and it analyzed the consequences. For example, it reported, labs routinely use a kidney function calculator that adjusts filtration rates for black patients. With the adjustment, black patients end up with slightly better rates than whites, which can be enough to make those with borderline rates ineligible to be on a kidney transplant list.

An online osteoporosis risk calculator endorsed by the National Osteoporosis Foundation, among others, calculates chances of a fracture differently for black and white women. Black women end up having a score that makes them less likely to be prescribed osteoporosis medication than white women who are similar in other respects.

An obstetric calculator based on observational data concludes that black women who had a previous cesarean birth are less likely to have a successful vaginal birth in a subsequent pregnancy.

Dr. Jones added that it is time to stop what amounts to racial profiling in medicine. “We need to get off this train,” he said.

The New England Journal paper built on a collection of recent findings and assessments, including those in a recent paper about kidney function by Dr. Nwamaka Denise Eneanya and her colleagues at the University of Pennsylvania.

To determine how well kidneys are working, doctors use a blood test that measures a protein called creatinine to estimate kidney filtration rate. Low filtration rates indicate a kidney problem.

Dr. Eneanya’s team noted that patients with a filtration rate of less than 30 were referred to kidney specialists. They gave an example of a white patient whose level was 28, according to the calculator. A black patient with the same creatinine level would get a race correction under the formula that raises the level to 33. Consequently, the black patient would not get a referral to a specialist.

The same effect could make some black patients ineligible to be put on a list for a kidney transplant — those with filtration rates of 20 or above are ineligible.

The formula originated with data from a federal study more than two decades ago that asked if a low-protein diet reduced the risk of kidney disease (it did not, the study showed). The study included precise measures of kidney function and creatinine levels, which let researchers use creatinine to estimate kidney function. The formula fit the data best when they included an adjustment for black patients.

In a more recent paper, in 2009, the researchers combined data from a number of studies to devise an improved formula, asking which variables made the formula best fit the data. Race popped up again.

“The formula was widely adopted,” said Dr. Melanie Hoenig, a kidney specialist at Harvard Medical School.

One of its principal authors, Dr. Lesley Inker, a kidney specialist at Tufts Medical Center, said she hears the critics.

“What we say is, ‘You’re right. I understand the difficulty in assigning race,’” Dr. Inker said.

She is working on developing a more accurate formula that does not include race. She added that black patients should be told that their race alters the calculation and should be given an option to have their race excluded.

But, she says, the current formula also can be an advantage for black patients. Those with filtration rates below 30 are ineligible to be prescribed metformin, the first line drug for diabetes, and SGLT2 inhibitors, a more recent class of diabetes drugs.

One problem is that it is not clear how race is determined. It shows up in medical records but, said Dr. Peter Reese, a kidney transplant specialist and epidemiologist at the University of Pennsylvania, “I worry that in some situations they look at you and assume.”

With the formulas, there is no accounting for people of mixed race, as the authors of the New England Journal paper and other doctors have noted.

Even if race does have a real affect on lab values for creatinine, why assume it is because of the genetics that determine skin color, some experts asked.

“It could be diet or any of a number of things,” Dr. Hoenig said, noting that a large protein-heavy meal can temporarily raise creatinine levels.

One often cited explanation is the belief that black people are more muscular than white people, and muscles can release creatinine into the blood. In a recent paper, Dr. Vanessa Grubbs, a kidney specialist at the University of California, San Francisco, tried to trace the origins of that belief and found only a few decades-old studies that did not even measure muscle mass directly, including one saying black children are thinner than white children.

A group of medical students at Harvard has been trying to change the approach to assessing kidney function, with some success.

The group, including Leo Eisenstein, Danika Barry and Cameron Nutt, had heard Dr. Jones in lectures saying race was a social construct and then went into the clinic, where they were told to use a formula that corrects for race in assessing kidney function.

Instead of complaining, Dr. Hoenig told the students, why not go to the leadership and suggest a change? Labs could simply not list race when sending in blood tests for creatinine — in that case the formula’s default would be the level for whites. Or they could give results as a range and explain to patients that the numbers are an estimate.

A few years ago, Dr. Hoenig and the students made the rounds to executives at Beth Israel Medical Center.

“We went to the chief of medicine, we went to the head of clinical labs, we went to the head of the kidney division, we went to a lot of people and spun our story,” she said. “They were open to it.”

In 2017, Beth Israel dropped the race factor in calculating kidney function. But despite pleas for a change, no other hospitals have followed suit.

Recently though, San Francisco General has replaced race as a factor with a choice of values for kidney function depending on the doctor’s assessment of whether the patient was muscular or not.

Advocates of change like Dr. Hoenig say they think part of the problem is resistance to changing a system that has become part of medicine.

Dr. Darshali A. Vyas of Massachusetts General Hospital, who is first author of the New England Journal paper, said the ultimate goal is for doctors and researchers to rethink the assumption that they can use a patient’s race in making medical decisions.

“This is a challenge to the field about how we think about race and what our default assumptions are about race,” she said.

Updated June 18, 2020