Little Device That Made UnitedHealth Billions

 A STAT

opens in a new tab or window investigation revealed how, from 2018 to 2021, UnitedHealth ramped up screening for peripheral artery disease (PAD) with the widespread use of a device called QuantaFlo. The practice, according to STAT, allowed the company to earn billions in reimbursement from taxpayer-funded Medicare Advantage for both "valid and questionable PAD diagnoses."

Doctors and experts told STAT the device was not accurate enough, and that false positives had worried their patients and likely led to unnecessary treatment. QuantaFlo was approved through an accelerated FDA pathway and was quickly incorporated into UnitedHealth's primary care clinics and a UnitedHealth home visit program in nearly every state that screened for the disease, even without symptoms, according to the report.

Several doctors described either ignoring the mandate from their employer to use QuantaFlo, or using more accurate tests to verify the diagnoses.

UnitedHealth's guidance for its home visit program supported screening with no symptoms of PAD, but its own guidance for its insurance plan medical reviewers advised against this.

In an email between UnitedHealth leadership, one executive wrote to another, "You mentioned vasculatory disease opportunities, screening opportunities, etc with huge $ opportunities. ... Lets [sic] turn on the gas!"

This year, CMS eliminated the diagnostic code for peripheral artery disease without complications, and UnitedHealth's screenings for PAD plummeted. The company that makes QuantaFlo, however, is now seeking approval from the FDA to use its devices to diagnose "heart dysfunction."

https://www.medpagetoday.com/special-reports/features/111511

Prior Authorizations on the Rise in Medicare Advantage, Report Finds

 Use of prior authorization in the Medicare Advantage (MA) program continues to increase, according to a report from KFF

opens in a new tab or window.

More than 46 million prior authorization requests were submitted to Medicare Advantage insurers on behalf of Medicare Advantage enrollees in 2022, up from 37 million in 2019, the report found. However, the average number of requests per enrollee was 1.7, the same as in 2019. "The rise in the total number of prior authorization requests corresponded to increasing enrollment in Medicare Advantage and so translated into a similar number of requests per enrollee," wrote report authors Jeannie Fuglesten Biniek, Nolan Sroczynski, and Tricia Neuman, all of KFF's Center on Medicare Policy.

Of the requests submitted, 90.4% were approved in full, while 7.4% were denied -- an increase from 5.7% in 2019, according to the report. And of those that were denied, about 10% were appealed, and of those, 83% resulted in the denial being overturned.

"While all Medicare Advantage insurers require prior authorizationopens in a new tab or window for at least some services, there is variation across insurers and plans in the specific services subject to these requirements," the researchers wrote. "In addition, insurers have the option of waiving prior authorization requirements for certain providers, for example, as part of risk-based contracts or through 'gold carding' programs that exempt providers with a history of complying with the insurer's prior authorization policies."

Not a Surprise

Healthcare groups said the report didn't surprise them. "Repeated investigations by [KFF] strongly suggest that the overuse of prior authorization controls by Medicare Advantage plans results in the denial of medically necessary healthcare," Bruce Scott, MD, president of the American Medical Association (AMA), said in an email to MedPage Today. "The KFF findings mirror physician experiences illustrated in the AMA's latest surveyopens in a new tab or window, which found that excessive authorization controls required by health insurers are responsible for serious harm when necessary medical care is delayed, denied, or disrupted."

Steven Furr, MD, president of the American Academy of Family Physicians (AAFP), noted that "prior authorizations and clinician burnout often go hand in hand." "As many practices struggle to balance the administrative burdens and responsibilities of running a practice amid considerable rising costs, closures, and staffing shortages, coupled with a lack of congressional action to address prior authorization, it's not surprising that burnout has increased and that the number of prior authorization requests are higher," he said in an email.

"We know that if 90% of prior authorization requests are approved, then these programs are not targeted efforts to ensure appropriate utilization," Furr continued. "Instead, they are arbitrary, unnecessary paperwork burdens that, at best, slow down access to care and increase burnout, and at worst completely deny access to care. Prior authorizations are harming patient care!"

Congressional Action On the Horizon

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association (MGMA), said that when it comes to Medicare Advantage, reducing the number of prior authorizations is "our top priority." (Disclosure: Gilberg is a member of the MedPage Today editorial board).

"The vast majority of prior authorizations are ultimately approved, and this report is yet another strong piece of evidence as to their frivolous nature," he said in an email. "Prior authorization continuously ranks as the most burdensome regulatory issue facing medical groups, with prior authorization requirements in the MA program rankingopens in a new tab or window as more burdensome than those in both commercial insurance and Medicaid."

Like the AMA and AAFP, MGMA is supporting a bill now in Congress known as the Improving Seniors' Timely Access to Care Actopens in a new tab or window, which has broad bipartisan support in both the House and Senate. That measure would:

• Establish an electronic prior authorization process
• Require HHS to establish a process for "real-time decisions" for items and services that are routinely approved
• Improve transparency by requiring Medicare Advantage (MA) plans to report to CMS on the extent of their use of prior authorization and the rate of approvals or denials
• Encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians

On the other side of the issue, Better Medicare Alliance, which represents MA plans, also supports the bill. "The cost of healthcare is a top concern for seniors, and prior authorization helps keep costs low for Medicare Advantage beneficiaries. But it shouldn't be a burden on patients," said Susan Reilly, vice president of communications at Better Medicare Alliance, in an email to MedPage Today. "We support common-sense efforts to streamline prior authorization for seniors, including the Improving Seniors' Timely Access to Care Act currently before Congress."

Addressing the CBO's Concerns

A previous versionopens in a new tab or window of the bill passed the House on a voice vote in 2022, but it hit a roadblock in the Senateopens in a new tab or window in the form of a cost estimateopens in a new tab or window from the Congressional Budget Office (CBO).

"By placing additional requirements on plans that use prior authorization, we expect [the bill] would result in a greater use of services," the CBO report said. "We expect Medicare Advantage plans would increase their bids to include the cost of these additional services, which would result in higher payments to plans." The CBO estimated that the bill would cost the federal government $16.2 billion over a 10-year period.

As a result, congressional supporters of the bill have now introduced a new version. "The bill sponsors have made several changes to lower the costs based on the input they received from the Congressional Budget Office," Katie Orrico, JD, CEO of the American Association of Neurological Surgeons, said in an email to MedPage Today. "While there are no guarantees, we anticipate that the changes should bring the cost down closer to zero. CBO will discount the costs to the extent that the bill mirrors the final rule CMS published earlier this year, thus paving the way for passage."

"The timing is uncertain at this time, but now that the bill has been introduced, we hope the CBO will swiftly analyze it, and Congress will advance it on a fast-track pathway," she added. "The alternative option is to incorporate this into any must-pass legislation this year." The current bill has 182 House cosponsors and 51 Senate cosponsors.

https://www.medpagetoday.com/practicemanagement/reimbursement/111500

Prevalence of problematic pharmaceutical opioid use in patients with chronic non-cancer pain

 Kyla H. Thomas, Michael N. Dalili, Hung-Yuan Cheng, Sarah Dawson, Nick Donnelly, Julian P. T. Higgins, Matthew Hickman

https://doi.org/10.1111/add.16616

Abstract

Background and aims

Chronic non-cancer pain (CNCP) is one of the most common causes of disability globally. Opioid prescribing to treat CNCP remains widespread, despite limited evidence of long-term clinical benefit and evidence of harm such as problematic pharmaceutical opioid use (POU) and overdose. The study aimed to measure the prevalence of POU in CNCP patients treated with opioid analgesics.

Method

A comprehensive systematic literature review and meta-analysis was undertaken using MEDLINE, Embase and PsycINFO databases from inception to 27 January 2021. We included studies from all settings with participants aged ≥ 12 with non-cancer pain of ≥ 3 months duration, treated with opioid analgesics. We excluded case–control studies, as they cannot be used to generate prevalence estimates. POU was defined using four categories: dependence and opioid use disorder (D&OUD), signs and symptoms of D&OUD (S&S), aberrant behaviour (AB) and at risk of D&OUD. We used a random-effects multi-level meta-analytical model. We evaluated inconsistency using the I2 statistic and explored heterogeneity using subgroup analyses and meta-regressions.

Results

A total of 148 studies were included with > 4.3 million participants; 1% of studies were classified as high risk of bias. The pooled prevalence was 9.3% [95% confidence interval (CI) = 5.7–14.8%; I2 = 99.9%] for D&OUD, 29.6% (95% CI = 22.1–38.3%, I2 = 99.3%) for S&S and 22% (95% CI = 17.4–27.3%, I2 = 99.8%) for AB. The prevalence of those at risk of D&OUD was 12.4% (95% CI = 4.3–30.7%, I2 = 99.6%). Prevalence was affected by study setting, study design and diagnostic tool. Due to the high heterogeneity, the findings should be interpreted with caution.

Conclusions

Problematic pharmaceutical opioid use appears to be common in chronic pain patients treated with opioid analgesics, with nearly one in 10 experiencing dependence and opioid use disorder, one in three showing signs and symptoms of dependence and opioid use disorder and one in five showing aberrant behaviour.

https://onlinelibrary.wiley.com/doi/10.1111/add.16616

Serve Robotics, Shake Shack Roll Out Autonomous Robot Delivery Via Uber Eats

 

• Select Shake Shack customers in the Los Angeles area may receive their next order via a Serve robot
• Serve continues to make progress towards its commitment to deploy up to 2,000 AI-powered sidewalk delivery robots on the Uber platform

https://www.prnewswire.com/news-releases/serve-robotics-and-shake-shack-roll-out-autonomous-robot-delivery-via-uber-eats-302222102.html

'Massive Cyberattack Cripples Central Bank Of Iran: Report'

 The opposition and Saudi-affiliated Iran International is reporting that the Central Bank of Iran has been hit with a large-scale cyber attack which is caused major disruption to the banking system across the Islamic Republic.

The outlet says the impact of the attack if far-reaching, suggesting it could be one of the largest cyberattacks on Iran's state infrastructure to date, coming amid soaring regional tensions with Israel

Earlier Wednesday, Iran's Supreme leader, Ayatollah Ali Khamenei, warned the country about threats of irregular warfare, stating, "The exaggeration of our enemies' capabilities is intended to spread fear among our people by the US, Britain, and the Zionists. The enemies' hand is not as strong as it is publicized. We must rely on ourselves."

He continued, "The enemy's goal is to spread psychological warfare to push us into political and economic retreat and achieve its objectives."

Could this reported major cyber attack be the work of Israeli intelligence? Likely many in Iran believe so.

Ironically it comes on the heels of claims by US officials and in Western media that Iranian state hackers are actively working to influence and interfere in the upcoming US elections.

However, there has been no proof of these allegations, but only references to poorly made spoof websites which seek to influence either conservative or liberal voters.

As for these Wednesday reports of a major cyber attack targeting Iranian banking, a story picked up in Israeli media as well, Iranian officials have not given official confirmation and state media sources remain silent thus far.

Last December, a major cyber attack took out a significant part of the country's gas stations, as it targeted widely used payment software, and Tehran attributed the disruption to Israel and the US.

Israel has long been known to target Iran's nuclear program with cyber attacks, some of which have reportedly been successful in crippling the operations of key sites in the past.

Two weeks have passed since Haniyeh's killing and Israeli leaders are still bracing for some kind of potential big retaliation from Iran. If it is accurate that Iran's central bank has been crippled in the attack, and if Israel is behind it, this could convince Tehran to finally pull the trigger on its long awaited retaliation.

https://www.zerohedge.com/geopolitical/massive-cyberattack-cripples-central-bank-iran-report

Acelyrin cut to Neutral from Buy by Wainwright

 Target to $6 from $18

https://finviz.com/quote.ashx?t=SLRN&p=d

Science journal buries high myocarditis risk in COVID vax, claims shot cuts heart attacks

A science journal published studies last month that alternately claimed COVID-19 vaccines vastly increase the risk of myocarditis, and lower the "incidence of common cardiovascular events" more than raising "known rare cardiovascular complications" such as myocarditis.

The July 23 study of 9.2 million South Koreans in Nature Communications, sibling to the better-known Nature, did not lead with the myocarditis results. The July 31 study of 45.7 million Britons emphasized how much greater the purported vaccine benefit was.

The differing emphases in two COVID vaccine studies published eight days apart in the same Springer Nature journal comes a year after Stanford medical professor and Great Barrington Declaration coauthor Jay Bhattacharya warned about the "concoction of pseudo-consensus in science and its ramifications for our society."

Nearly two years ago, Stanford Med's Robert Kaplan, UCLA medical and public health professors Patrick Whelan and Sander Greenland, and British Medical Journal senior editor Peter Doshi estimated a 1-in-800 rate of serious adverse events in adults following mRNA vaccination based on Pfizer and Moderna trials, staggeringly high relative to previous vaccines.

The South Korean paper's corresponding author Solam Lee told Just the News that "any reviewers, editors, or Nature Communications did not exert any influence on our research or its findings."

Nature Communications did not respond to Just the News queries Monday on its editorial choices regarding the portrayal of myocarditis in the two studies. The corresponding author of the British paper didn't respond either.

The South Korean study's findings got noticed and publicized by Robert F. Kennedy Jr.'s vaccine-skeptical Children's Health Defense days before the British study was published.

The study’s purpose was nailing down the association between mRNA vaccination and "autoimmune connective tissue diseases," finding that jabs did not increase the risk for developing "most" AI-CTDs except for a 1.16-fold risk for the most common form of lupus relative to the "historical control cohort," composed of people two years before their vaccination.

The study did find that boosting — a third dose — was "associated with an increased risk of some AI-CTDs including alopecia areata, psoriasis, and rheumatoid arthritis." The data came from National Health Insurance Service and Korea Disease Control and Prevention Agency databases, which cover 99% of the population and its COVID vaccination profiles.

The authors, all from Yonsei University's Department of Dermatology, didn't use unvaccinated people as controls for fear of "inappropriate cohort selection and potential selection bias." (South Korea's two-dose vaccination rate was already nearly 97% in October 2022.)

CHD Chief Scientific Officer Brian Hooker said he was perplexed the authors took it as "ho hum" that myocarditis, pericarditis and Guillain-Barré syndrome were associated with vaccination, as if those serious adverse events weren't worth reconsidering the value proposition.

The authors said they used those serious adverse events as "positive control outcomes" to validate their findings on the AI-CTDs. 

The adjusted hazard ratio for myocarditis was 7.20 at the 99% confidence interval, meaning a 620% greater risk following vaccination, though the CI was wide (4.37-11.86). The CIs were far narrower for pericarditis and GBS, with aHRs of 2.75 (175% increased risk) and 1.62 (62%).

Only mentioned in a figure: Females had twice the aHRs of males for myocarditis and pericarditis, though the CIs were also wide.

The increased risk for bullous pemphigoid, a blister condition that primarily affects elderly people, was 53% overall but three times higher for women specifically. The authors pointed this out in the text, unlike for the sex disparity on heart inflammation.

About 2.2 million people had a third dose in the vaccination cohort, and their increased risks of alopecia areata, psoriasis and rheumatoid arthritis compared to non-boosted people were 12%, 16% and 14% respectively.

The authors warned that the booster finding "should be interpreted cautiously" because a third jab can restore waning efficacy and reduce COVID severity. They also referred to "healthy vaccine effect," which refers to an overestimation of vaccine efficacy by virtue of healthy people being more likely to get jabbed, to caution on the booster finding.

Lee, the corresponding author, told Just the News the study was "primarily and specifically designed to examine the incidence" of AI-CTDs.

"Consequently, the analysis regarding myocarditis in our study was not finely tuned, and our research does not aim to assert an increased risk of myocarditis," Lee said. 

Regarding the British study, Lee said "I believe it may not be appropriate to directly compare the results of these studies on a one-to-one basis."

The British study got far more attention by virtue of NBC News analyst Vin Gupta of the University of Washington's Institute for Health Metrics and Evaluation, known for its early alarmist COVID models and claim that cloth masks could save 30,000 lives in three months.

Echoing Gupta's faith in modeling studies, the paper claims COVID vaccination saved 14.4 million lives in the pandemic's first year based on a mathematical model. 

It also asserts that the first vaccine dose "led to an overall reduction in cardiovascular events" and purports to study the effect of the second and third doses, using the National Health Service England Secure Data Environment and Office of National Statistics death registrations.

"The incidence of common arterial thrombotic events (mainly acute myocardial infarction and ischaemic stroke) was generally lower after each vaccine dose, brand and combination," as was "common venous thrombotic events, (mainly pulmonary embolism and lower limb deep venous thrombosis)," the authors wrote.

They used the word "rare" 10 times in the study's body, always referring to cardiovascular adverse events following vaccination — myocarditis for mRNA vaccines and "vaccine-induced thrombotic thrombocytopenia" for adenovirus-based vaccines.

The study "offers reassurance regarding the cardiovascular safety of COVID-19 vaccines," the authors conclude. "We hope this evidence addresses public concerns, supporting continued trust and participation in vaccination programs and adherence to public health guidelines."

NBC's Gupta argued that this "result isn’t what the legions of white coats who continue to spread misinformation were hoping for," in a post on X Aug. 1.

University of California San Francisco epidemiologist Vinay Prasad, an expert in trial design, wrote in his newsletter Aug. 3 that those who accept the paper's "conclusions at face value are not good at reading medical science."

The first problem is the paper glides over its own data by assuming "the people who get 0 doses [are] similar to those who get 1,2, and 3 doses," Prasad wrote. He also made an accompanying video.

It uses a geography-based poverty measurement that shows those who are most deprived and current smokers are far more likely to be unvaccinated or not boosted than those least deprived and who formerly or never smoked. Prasad doesn't care for the variable because it doesn't compare "individual household wealth and income among vaccine recipients."

The authors didn't try to measure the "residual confounding" of healthier people having fewer heart attacks in general — not because they are "obedient" and keep getting jabbed — and those who plan to get boosted but have cardiac events first, Prasad said.

He suggested he was most baffled by the journal's failure to demand "falsification testing" from the authors — "the rate of things that boosters could not possible lower, like car accidents or non-covid mortality" — and their atypical finding that subsequent doses have even greater effects than the first dose.

https://justthenews.com/politics-policy/coronavirus/science-journal-buries-high-myocarditis-risk-covid-vax-claims-it