By Michelle Andrews, KHN, May 17, 2022.

Andrew Bade, who was diagnosed with Type 1 diabetes nearly two decades ago, is accustomed to all the medical gear he needs to keep his blood sugar under control. His insulin pump contains a disposable insulin cartridge, and a plastic tubing system with an adhesive patch keeps in place the cannula that delivers insulin under his skin. He wears a continuous glucose monitor on his arm.

Bade, 24, has used the same equipment for years, but every three months when he needs new supplies, his health insurance plan requires him to go through an approval process called prior authorization.

Getting that approval can take as many as three weeks, and Bade sometimes runs out of insulin before it comes through. When that happens, the resident of Fenton, Michigan, makes do with leftover preloaded insulin pens. They’re less precise than the pump, and he feels tired when he uses them. But they get him through.

“I don’t understand why they’re taking all this time to make these decisions and then they always say ‘yes’ anyway,” Bade said.

Michigan legislators in April sought to help patients like Bade by approving a law that sets standards meant to hasten that process. Beginning in June 2023, health plans will have to act on non-urgent prior authorization requests in nine calendar days and on urgent requests in 72 hours. In 2024, the time frame for non-urgent requests will shrink to seven days.

“We are ecstatic that it passed,” said Dr. Nita Kulkarni, an obstetrician-gynecologist in Flint and a member of the board of directors for the Michigan State Medical Society, which has pushed for the law for years. “It’s a step in the right direction in decreasing the wait time for therapy.”

Michigan’s law is the most recent example of efforts by states, insurers, and doctors to un-gum a process that is notoriously sticky. Yet most of the initiatives have had limited success.

At least a dozen states have passed broad reforms, according to tracking by the American Medical Association. Others have passed narrower laws that target the process or certain types of medical care or drugs. However, state laws don’t protect most patients because they are in so-called self-funded plans, in which the employer pays claims directly rather than buying insurance for that purpose. Self-funded plans are generally regulated by the federal government, not states. There’s no broad protection at the federal level for people with commercial coverage.

A 2018 consensus statement issued by key health plan and medical provider groups to improve the process has been slow to make inroads.

Prior authorization requirements are intended to reduce wasteful and inappropriate health care spending. Few would disagree with that goal. Studies have found that about a quarter of health care spending is wasteful, whether because of overtreatment, overpricing, fraud and abuse, or problems with health care coordination and delivery.

Health plans say that prior authorization requirements help them protect patients’ safety and improve the quality of care, in addition to rooting out waste and error. Doctors disagree. They say that the process too often leads to delays in patient care and that those delays can sometimes cause consumers to abandon treatment.

The complaints aren’t confined to regular commercial coverage. A report released in April by the U.S. Department of Health and Human Services’ inspector general examined a random sample of 250 prior authorization denials at 15 large Medicare Advantage plans in June 2019. It found that 13% of prior authorization denials by Medicare Advantage plans were for services that met Medicare coverage rules.

Health plans’ use of such requirements continues to rise, according to medical groups. In a March poll, 79% of medical practices said that prior authorization requirements had increased in the previous year, according to the Medical Group Management Association.

Even though insurers and providers may fundamentally disagree on the usefulness of prior authorization, many agree that the process needs to be improved. The consensus statement listed several areas that the groups agreed need fixing. For example, they said doctors and other health care providers who follow evidence-based treatment guidelines and have historically had high prior authorization approval rates may sidestep the process.

The groups also agreed that regular review of these requirements is a good idea, with an eye toward eliminating therapies from the list that no longer warrant it. Improved transparency and automation also made the list.

But doctors say that insurers have made little progress in the four years since the document was released.

“It’s been abysmal,” said Dr. Jack Resneck Jr., a dermatologist who is president-elect of the American Medical Association. “We see the problem getting worse, and we don’t see health plans taking any action to honor the commitments they made.”

Insurers say they’re working through the items on the list.

“We believe that a number of the concerns can be solved by innovations in technology,” said Kris Haltmeyer, vice president of policy analysis at the Blue Cross Blue Shield Association, one of the six organizations that partnered on the statement. He pointed to an electronic prior authorization pilot project undertaken by the insurers’ trade group, AHIP, that resulted in a 69% reduction in the decision time on requests, to just under six hours.

That sort of speedy turnaround would have made a big difference to Jodi Burk, 63, who has rheumatoid arthritis. Burk, who lives in Bellaire, Michigan, takes pricey biologic medications to control her pain and other symptoms. A few years ago, her medication stopped working, and the pain became so bad that she could no longer even take her dog for walks.

Her doctor prescribed a different biologic that she thought would treat her symptoms. But the insurer wouldn’t approve the prescribed drug until she had tried — and failed — four other medications, a prior authorization process called step therapy.

It was five months before Burk was approved and began taking a drug that effectively treated her symptoms. “With these time frames, you’re not getting any better,” Burk said. “You hurt more, and your life is put on hold. There were lots of things that I used to be able to do and couldn’t during those times.”

In addition to establishing time frames for acting on prior authorization requests, the new Michigan law sets standards for notifying doctors and other health care providers about changes or additions to existing requirements. And it requires insurers to implement standardized electronic transaction processes for prior authorization requests.

That standard web-based process was a key element of the law for insurers, said Dominick Pallone, executive director of the Michigan Association of Health Plans.

“Many times [providers] submit incomplete or incorrect information,” Pallone said. “We’re trying to make it easier for the provider to go through and complete it quickly.”

“At the end of the day, we do feel we reached a good compromise,” he said.

Article link: https://khn.org/news/article/prior-authorization-treatment-insurers-doctors-faster/

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 Rae Ellen Bichell and Cara Anthony, The Washington Post, Jun 06, 2021.

Alphonso Harried recently came across a newspaper clipping about his grandfather receiving his 1,000th dialysis treatment. His grandfather later died — at a dialysis center — as did his uncle, both from kidney disease.

“And that comes in my mind, on my weak days: ‘Are you going to pass away just like they did?’ ” said Harried, 46, who also has the disease.

He doesn’t like to dwell on that. He has gigs to play as a musician, a ministry to run with his wife, and kids to protect as a school security guard.

Yet he must juggle all that around three trips each week to a dialysis center in Alton, Ill., about 20 miles from his home in St. Louis, to clean his blood of the impurities his kidneys can no longer flush out. He is waiting for a transplant, just as his uncle did before him.

“It’s just frustrating,” Harried said. “I’m stuck in the same pattern.”

Thousands of other Americans with failing kidneys are also stuck, going to dialysis as they await new kidneys that may never come. That is especially true of Black patients, like Harried, who are about four times as likely to have kidney failure as White Americans, and who make up more than 35 percent of people on dialysis but just 13 percent of the U.S. population. They’re also less likely to get on the wait list for a kidney transplant, and less likely to receive a transplant once on the list.

An algorithm doctors use may help perpetuate such disparities. It uses race as a factor in evaluating all stages of kidney disease care: diagnosis, dialysis and transplantation.

It’s a simple metric that uses a blood test, plus the patient’s age and sex and whether they’re Black. It makes Black patients appear to have healthier kidneys than non-Black patients, even when their blood measurements are identical.

“It is as close to stereotyping a particular group of people as it can be,” said Rajnish Mehrotra, a nephrologist with the University of Washington School of Medicine.

This race coefficient has recently come under fire for being imprecise, leading to potentially worse outcomes for Black patients and less chance of receiving a new kidney. A national task force of kidney experts and patients is studying how to replace it. Some institutions have already stopped using it.

But how best to assess a patient’s kidney function remains uncertain, and some medical experts say fixing this equation is only one step in creating more equitable care, a process complicated by factors far deeper than a math problem.

“There are so many inequities in kidney disease that stem from broader structural racism,” said Deidra Crews, a nephrologist and the associate director for research development at the Johns Hopkins Center for Health Equity. “It is just a sliver of what the broader set of issues are when it comes to both disparities and inequities in who gets kidney disease in the first place, and then in the care processes.”

The racial part of the equation

Kidneys filter about 40 gallons of blood a day, like a Brita filter for the body. They keep in the good stuff and send out the bad through urine. But unlike other organs, kidneys don’t easily repair themselves. “There’s a point of no return,” said Cynthia Delgado, a nephrologist at the University of California at San Francisco who is leading the task force working on the national recommendation to ditch the racial part of the equation.

Furthermore, it’s hard to gauge whether kidneys are working properly. Gold-standard tests involve a chemical infusion and hours of collecting blood and urine to see how quickly the kidneys flush the chemical out. An algorithm is much more efficient.

Buoyed by activism around structural racism, those seeking equity in health care have recently been calling out the algorithm as an example of the racism baked into American medicine. Researchers writing in the New England Journal of Medicine last year included kidney equations in a laundry list of race-adjusted algorithms used to evaluate parts of the body — from heart and lungs to bones and breasts. Such equations, they wrote, can “perpetuate or even amplify race-based health inequities.”

In March, ahead of the national task force’s upcoming formal recommendation, leaders in kidney care said race modifiers should be removed. And Fresenius Medical Care, one of the two largest U.S. dialysis companies, said the race component is “problematic.”

Until the late 1990s, doctors primarily used the Cockcroft-Gault equation. It didn’t ask for race, but used age, weight and the blood level of creatinine — a chemical that’s basically the trash left after muscles move. A high level of creatinine in the blood signals that kidneys are not doing their job of disposing of it. But the equation was based on a study of just 249 White men.

Then, researchers wrapping up a study on how to slow down kidney disease realized they were sitting on a mother lode of data that could rewrite that equation: gold-standard kidney function measurements from about 1,600 patients, 12 percent of whom were Black. They evaluated 16 variables, including age, sex, diabetes diagnosis and blood pressure.

They landed on something that accurately predicted the kidney function of patients better than the old equation. Except it made the kidneys of Black participants appear to be sicker than the gold-standard test showed they were.

The authors reasoned it might be caused by muscle mass. Participants with more muscle mass would probably have more creatinine in their blood, not because their kidneys were failing to remove it, but because they just had more muscles producing more waste. So, they “corrected” Black patients’ results for that difference.

Andrew S. Levey, a professor at Tufts University School of Medicine who led the study, said it doesn’t make intuitive sense to include race — now widely considered a social construct — in an equation about biology.

Still, in 1999, he and others published the race equation, then updated it a decade later. Though other equations exist that don’t involve race, Levey’s latest version, often referred to as the “CKD-EPI” equation, is recommended for clinical use. It shows a Black patient’s kidneys functioning 16 percent better than those of a non-Black patient with the same bloodwork.

Removing the race number

Many patients don’t know about this equation and how their race has factored into their care.

“I really wish someone would have mentioned it,” Harried said.

He said it burned him up “knowing that this one little test that I didn’t know anything about could keep me from — or prolong me — getting a kidney.”

Glenda V. Roberts curbed her kidney disease with a vegan diet and by conducting meetings as an information technology executive while walking. But after more than 40 years of slow decline, her kidney function finally reached the cutoff required to get on the transplant wait list. When it did, the decline was swift — a pattern researchers have noted in Black patients.

“It really makes you wonder what the benefit is of having an equation that will cause people who look like me — Black people — to get referrals later, to have to wait longer before you can get on the transplant list, but then have your disease progress more rapidly,” she said.

Roberts, who is now the director of external relations at the University of Washington’s Kidney Research Institute in Seattle and on the national task force, said a genetic test added to her feeling that a “Black/non-Black” option in an equation was a charade.

“In fact, I am not predominantly of African ancestry. I’m 25 percent Native American. I’m Swedish and English and French,” Roberts said. “But I am also 48 percent from countries that are on the continent of Africa.”

The Black/non-Black question also doesn’t make sense to Delgado. “I would probably for some people qualify as being non-Black,” said Delgado, who is Puerto Rican. “But for others, I would qualify as Black.”

So, theoretically, if Delgado were to visit two doctors on the same day, and they guessed her race instead of asking, she could come away with two different readings of how well her kidneys are working.

Researchers found that the race factor doesn’t work for Black Europeans or patients in West Africa. Australian researchers found using the race coefficient led them to overestimate the kidney function of Indigenous Australians.

But in the United States, Levey and other researchers seeking to replace the race option with physical measurements, such as height and weight, hit a dead end.

To Crews, who is also on the national task force, the focus on one equation is myopic. The algorithm suggests that something about Black people’s bodies affects their kidneys. Crews thinks that’s the wrong approach to addressing disparities: The issue is not what’s unique about the inner workings of Black bodies, but instead what’s going on around them.

“I really wish we could measure that instead of using race as a variable in the estimating equations,” she said on the “Freely Filtered” podcast. “I don’t think it’s ancestry. I don’t think it’s muscle mass.”

It might not be that Black bodies are more likely to have more creatinine in the blood, but that Americans who experience housing insecurity and barriers to healthy food, quality medical care and timely referrals are more likely to have creatinine in their blood — and that many of them happen to be Black.

Systemic health disparities help explain why Black patients have unusually high rates of kidney failure, since communities of color have less access to regular primary care. One of the most serious consequences of poorly controlled diabetes and hypertension is failure of the organ.

Direct discrimination — intentional or not — from providers may also affect outcomes, Roberts said. She recalled a social worker categorizing her as unable to afford the post-transplant drugs required to keep a transplanted organ healthy, which could have delayed her getting a new organ. Roberts has held executive roles at several multimillion-dollar companies.

Delgado and Levey agree that removing race from the formula might feel better on the surface, but it isn’t clear the move would actually help people.

Studies recently published in the Journal of the American Medical Association and the Journal of the American Society of Nephrology noted that removing the race factor could lead to some Black patients being disqualified from using beneficial medications because their kidneys might appear unable to handle them. It could also disqualify some Black people from donating a kidney.

“Fiddling with the algorithms is an imperfect way to achieve equity,” Levey said.

As researchers debate the math problem and broader societal ones, patients such as Harried, the St. Louis minister and security guard, are still stuck navigating dialysis.

“One of things that keeps me going is knowing that soon they may call me for a kidney,” Harried said.

He doesn’t know how long his name will be on the transplant wait list — or whether the race coefficient has prolonged the wait — but he keeps a hospital bag under his bed to be ready.

Article link

By Katie Adams, Backer’s Hospital Review, Apr 06, 2021.

The Baltimore Emergent BioSolutions plant, where 15 million Johnson & Johnson COVID-19 vaccine doses were ruined, has a history of quality control failures, some of which have gone unaddressed, The New York Times reported April 6.

The 15 million doses were ruined after employees mixed up ingredients for Johnson & Johnson’s and AstraZeneca’s COVID-19 vaccines. AstraZeneca had also contracted with Emergent to make its vaccines there, but HHS has ordered Emergent to stop making the AstraZeneca vaccine at that plant to avoid further mistakes. 

HHS directed Johnson & Johnson to oversee COVID-19 vaccine manufacturing and said it would help AstraZeneca look for an alternate site. The error has delayed future shipments of Johnson & Johnson’s vaccine in the U.S. while the FDA investigates how the error occurred. 

Documents reviewed by the Times revealed that an AstraZeneca audit of the site uncovered a high probability of cross contamination. Current and former federal officials as well as former Emergent employees told the newspaper little was done to address these concerns, despite Emergent receiving a $163 million federal contract to prepare the site for high-volume manufacturing.

Mold contamination, inadequate employee training, failure to properly clean equipment and failure to test raw materials were among other concerns revealed by other audits, according to the Times.

Matt Hartwig, Emergent’s media relations director, told the Times, “Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false.”

Article link: https://www.beckershospitalreview.com/pharmacy/emergent-plant-where-15m-j-j-vaccine-doses-ruined-has-history-of-failed-quality-audits.html

Hospitals and doctors’ offices nationwide might have avoided nearly 2,000 patient deaths — and $1.7 billion in malpractice costs — if medical staff and patients communicated better, a report released Monday has found.

Communication failures were a factor in 30 percent of the malpractice cases examined by CRICO Strategies, a research and analysis offshoot of the company that insures Harvard-affiliated hospitals. The cases — including 1,744 deaths — involve some horror stories that no family, and no medical professional, wants to experience.

In one instance, a nurse failed to tell a surgeon that a patient experienced abdominal pain and a drop in the level of red blood cells after the operation — alarming signs of possible internal bleeding. The patient later died of a hemorrhage.

Related: Small share of doctors account for bulk of malpractice payouts

In another, medical office staff received calls from a diabetic patient, but did not relay the messages to the patient’s primary care provider, so the patient never got a call back. The patient later collapsed and died from diabetic ketoacidosis, which arises when the body doesn’t have enough insulin.

In a third case, a woman asked to have her tubes tied after delivering a baby through a C-section, but her instructions were not shared with the obstetrician on duty. The patient filed a malpractice claim when she got pregnant again.

Frank Federico, vice president for patient safety at the Institute for Healthcare Improvement in Cambridge, Mass., called the findings disappointing because they suggest two decades of work has achieved too little progress. He said advocates have been pushing to improve communication ever since Boston Globe health reporter Betsy Lehman died in 1994 from a chemotherapy overdose at Dana-Farber Cancer Institute, which helped to incite the national patient safety movement.

“We’ve been working on this for a long time, and it still continues to be a big problem,” said Federico, who previously worked at CRICO as a patient safety specialist.

The report cites many challenges, such as heavy workload, hierarchical workplace culture, cumbersome electronic health records, and constant interruptions. And it highlights solutions, including a program called I-PASS born at Boston Children’s Hospital.

The data in the report aren’t comprehensive — they represent about a third of all paid malpractice claims nationwide — but come from a representative slice of hospitals and doctors’ offices across the country, said report co-author Gretchen Ruoff, senior program director for patient safety at CRICO.

Analysts examined clinical and legal records in 23,658 malpractice cases from 2009 to 2013. They identified over 7,000 cases where communication failures, either among medical staff or between medical staff and patients, harmed patients.

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The report found that, while electronic medical records have emerged partly to improve communications, in some cases they have the opposite effect.

For instance, one woman’s cancer diagnosis was delayed for an entire year because her lab result was plugged into the electronic health record but was not flagged to her primary care provider.

In another case, a primary care provider referred a patient to a lung doctor but didn’t mention lab results signaling possible early congestive heart failure, assuming that doctor would see the results in the electronic medical record. About nine days later, the patient was rushed to the emergency room and died after his lungs filled with fluid.

The impact of miscommunication on medical errors is likely even greater than the report indicates, because it looked just at malpractice cases, said Dr. Christopher Landrigan, a patient safety researcher and pediatrician who directs the inpatient program at Boston Children’s.

Miscommunication among medical staff while transferring patients contributed to 80 percent of serious medical errors, according to one estimate by the Joint Commission, a group that sets safety standards and accredits health care organizations.

Landrigan is part of a team that is trying to improve communication through I-PASS, a methodical way to relay information during patient “handoffs” when doctors and nurses change shifts.

The program began at Children’s in 2008, in a pilot study sponsored by CRICO. Landrigan and his colleague Dr. Amy Starmer then showed in a New England Journal of Medicine study that medical errors dropped by 23 percent when nine other pediatric hospitals implemented I-PASS.

Now the method is spreading to 32 other hospitals in the United States, including those that treat adults, such as Brigham and Women’s Hospital in Boston’s Longwood Medical Area.

“We were doing our own work at the Brigham on how to improve handoffs, and we sort of realized that I-PASS is better,” said Dr. Jeffrey Schnipper, director of clinical research for the Brigham’s hospitalist service.

One recent evening, Schnipper took notes as five residents and interns handed off patients using I-PASS, which was introduced at the hospital last fall. I-PASS is a mnemonic device standing for: illness severity, patient summary, action list, situation awareness and contingency planning, and synthesis by receiver.

As intern Julia Beamesderfer heard a rundown of the 17 patients she would be caring for on the twilight shift, the doctor-in-training practiced the final “s,” synthesizing the information and reading it back to her colleagues.

One patient came with special instructions: The elderly woman had just been diagnosed with metastatic cancer, but she didn’t know that yet. The question came up: Who’s going to break the news? The doctors decided who would do it, and how.

That’s one piece of information that could easily get lost in the shuffle as doctors head home after an exhausting shift. The doctors also ran through action plans, such as how much pain medication to give.

“When we’re rushed, we definitely don’t do every part of it,” Beamesderfer said of the I-PASS protocol. But she said she has found it helpful to take a more active role when receiving her caseload, rather than passively listening to instructions.

IHI’s Federico said that for patient safety programs like I-PASS to take off, hospitals have to create a culture of psychological safety, where all medical staff feel free to speak up without fear of being punished or ridiculed. And medical staff need to “speak with patients in a way they can understand,” in a way that addresses their concerns.

While some hospitals are making improvements, Federico said, those efforts are not spreading quickly enough throughout the health care system.

“We don’t have a lot of time,” he said. “We should be making care as safe as possible as soon as possible.”

FEBRUARY 1, 2016