Today's News and Commentary

Biden to issue executive order to curtail noncompete clauses: This action will have a huge impact on healthcare, affecting both the product and service sectors. In the latter category, it is typical for physician contracts to have a restrictive covenant for a reasonable geographic area and time period. Without such a clause, a practice could help new physicians build their practices. When the practices are built, those physicians could leave with their patients. Stay tuned for legal challenges.
”The president’s order would encourage the Federal Trade Commission (FTC) to ban or limit noncompete agreements.
’Roughly half of private sector businesses require at least some employees to enter noncompete agreements, affecting over 30 million people. This affects construction workers, hotel workers, many blue-collar jobs, not just high-level executives. He believes that if someone offers you a better job, you should be able to take it. It makes sense,’ White House press secretary Jen Psaki said during a press briefing.”

About Covid-19

New study on delta variant reveals importance of receiving both vaccine shots, highlights challenges posed by mutations: “A peer-reviewed report from scientists in France, published Thursday in the journal Nature, found that the delta variant has mutations that allow it to evade some of the neutralizing antibodies produced by vaccines or by a natural infection. A single shot of a two-dose vaccine ‘barely’ offers any protection.
But the experiments found that fully vaccinated people — with the recommended regimen of two shots of the Pfizer-BioNTech or AstraZeneca vaccine — should retain significant protection against the delta variant. That echoes another report authored by a collaboration of scientists in the United States and published Wednesday in the New England Journal of Medicine.”
And in related articles:
Delta variant already dominant in U.S., CDC estimates show: “According to the [CDC]'s estimates the Delta variant became dominant in the country over the two weeks ended July 3, with 51.7% cases linked to the variant that was first identified in India.”
Vaccine Stocks Skid As Delta Variant Becomes More Prevalent U.S. Covid Strain: “Moderna stock toppled 4.9% and BioNTech's slipped 3.6%, while Novavax, which does not yet have an authorized vaccine, slumped 13.7%, the news source said.” Given the data on vaccine effectiveness and the companies’ research to develop new vaccines, this drop in stocks is puzzling.

Quidel recalls Lyra Covid test due to high risk of false negative results: “Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use.”

Kynurenic acid may underlie sex-specific immune responses to COVID-19: “Males and females have different immune responses to SARS-CoV-2 infection, with male sex being a risk factor for mortality, particularly among older individuals. Cai et al. performed metabolomics analysis of serum from COVID-19 patients and uninfected health care workers and identified 17 metabolites that were associated with the disease. However, in male COVID-19 patients only, the amount of the tryptophan metabolite kynurenic acid (KA) correlated with age, inflammation, and disease outcome. KA inhibits glutamate release, and glutamate abundance was reduced in patients who deteriorated. Together, these findings indicate that KA is associated with sex-specific differences in immune responses to COVID-19, suggesting that it might be targeted in male patients.”

SEC claims Parallax Health Sciences, execs misled about COVID-19 tests, PPE: “Without admitting or denying the allegations, Parallax, its CEO Paul Arena, and CTO Nathaniel Bradley consented to judgments permanently enjoining them from future violations of the charged provisions and requiring them to pay penalties of $100,000, $45,000, and $40,000, respectively, according to the SEC…
In the SEC’s complaint filed in the U.S. District Court for the Southern District of New York, the commission says that Parallax issued several press releases over March and April 2020, falsely claiming that the company’s purported COVID-19 test would be ‘available soon.’ The company also said it had medical and personal protective equipment (PPE) — which was in particularly high demand at that early stage of the pandemic — for ‘immediate sale.’
The SEC’s complaint alleges that Parallax’s insolvency prevented it from developing the COVID-19 test. At the same time, company projections demonstrated that even with the funds, it would take more than one year to develop the test. Additionally, the SEC alleges that Parallax never had the medical equipment or PPE that it offered.”

About pharma

Biogen, FDA walk back controversial Aduhelm label after weeks of fierce criticism: “Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowing the recommended window of patients to only those with milder forms of the memory-robbing disease. 
Biogen on Thursday said the FDA approved an updated label for Aduhelm, also known as aducanumab, that recommends the amyloid-beta targeting antibody for people with mild cognitive impairment or mild dementia, aligned with those included in Biogen’s late-stage trials. 
The FDA warns that there is ‘no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.’”

OxyContin maker Purdue wins 15 states' support in controversial $4B bankruptcy plan: “Fifteen states, including Massachusetts and New York, have blessed OxyContin maker Purdue Pharma's controversial bankruptcy reorganization plan, a court filing in the U.S. Bankruptcy Court in White Plains, New York, shows.
Under the deal, Purdue would morph into a nonprofit and secure protection from future opioid litigation. The company's owners, the Sackler family, would pay more than $4 billion in a settlement covering thousands of cases linked to Purdue's role in the opioid crisis.“

Humira's reign as TV ad king is over as AbbVie shifts spending to Rinvoq and Skyrizi: “AbbVie had been ratcheting back the brand’s TV budget over the past few months, but, in May, it stopped spending in arthritis and psoriasis altogether. That left $13 million in ads for Crohn’s disease and ulcerative colitis, only big enough for fourth place, according to data from real-time TV ad tracker iSpot.tv.
Of course, that doesn’t mean parent drugmaker Abbvie is giving up on TV advertising. Quite the opposite: Its next-generation treatments Rinvoq, for rheumatoid arthritis, and Skyrizi for psoriasis are on the list at Nos. 2 and 8, respectively.”

Ex-Genentech staffers plead guilty to trade secrets theft as DOJ targets biotech partners for $101M Sanofi deal: “The two Genentech veterans stole confidential intellectual property related to the company’s top-selling cancer drugs Rituxan, Herceptin and Avastin, plus cystic fibrosis inhalation Pulmozyme, the government said. They then passed that info to Taiwanese firm JHL Biotech, now called Eden Biologics, to help it develop cheap copycats, according to the suit.”

About the public’s health

Dietary recommendations for prevention of atherosclerosis: The latest recommendations on healthy eating. See the Graphical Abstract for a summary.

Mortality Among Persons Entering HIV Care Compared With the General U.S. Population: “Overall 5-year mortality among persons entering HIV care was 10.6%, and mortality among the matched U.S. population was 2.9%, for a difference of 7.7 (95% CI, 7.4 to 7.9) percentage points. This difference decreased over time, from 11.1 percentage points among those entering care between 1999 and 2004 to 2.7 percentage points among those entering care between 2011 and 2017.”
We have certainly come a long way in HIV treatment. Now we can work more on prevention/cure.

Projecting the risk of mosquito-borne diseases in a warmer and more populated world: a multi-model, multi-scenario intercomparison modelling study: Yet another deleterious consequence of global warming: “Rising global mean temperature will increase the climatic suitability of both diseases [malaria and dengue] particularly in already endemic areas. The predicted expansion towards higher altitudes and temperate regions suggests that outbreaks can occur in areas where people might be immunologically naive and public health systems unprepared. The population at risk of malaria and dengue will be higher in densely populated urban areas in the WHO African region, South-East Asia region, and the region of the Americas, although we did not account for urban-heat island effects, which can further alter the risk of disease transmission.”

About hospitals and health systems

UVA Health acquires full ownership of 3-hospital joint venture from Novant Health: “Novant Health UVA Health System’s 260 inpatient beds will push UVA Health’s tally over the 1,000-bed threshold.
The academic health system is led by its 600-bed flagship hospital, UVA Medical Center. It also runs the 106-bed UVA Children’s Hospital, UVA School of Medicine, UVA School of Nursing and UVA Physicians Group.”

Hospital M&A activity shifts to regional partnerships: Kaufman Hall: “Total M&A revenue in the first and second quarter totaled $17.2 billion on 27 transactions. This is the second highest in recent years, according to the report. In 2020, revenue for the same period was $17 billion with 43 transactions. 
In the second quarter, M&A volume was below historic volume with 14 transactions. However the quarter saw a high number of transactions with revenues above $500 million.”

About healthcare IT

Monthly Telehealth Regional Tracker: The site provides monthly telehealth utilization data by region.

Ransomware attack on revenue cycle vendor exposes 1.2 million patients, employees: “A ransomware attack on Practicefirst Medical Management Solutions and PBS Medcode has left more than 1 million people exposed after hackers stole patient files…
An investigation discovered that hackers copied protected health information, exposing 1,210,688 people. Stolen data includes names, Social Security numbers, bank account information, treatment-related information and more.”

Sonde Health Vocal Biomarker Technology Optimized on Qualcomm Snapdragon Mobile Platforms: “Sonde Health announced that it will work with leading chipmaker Qualcomm Technologies, Inc. to optimize Sonde’s vocal biomarker technology for use with the flagship and high-tier Qualcomm® Snapdragon™ 888 and 778G 5G Mobile Platforms to help bring native, machine learning-driven vocal biomarker capabilities to mobile and IoT devices globally. The optimization has the potential to unlock several native health screening and monitoring applications on hundreds of millions of mobile devices that use these Snapdragon mobile platforms.”

About health insurance

Physicians push back against new Aetna cataract surgery policy: “Two professional organizations issued a joint statement voicing their opposition to Aetna's new policy that requires preapproval for all cataract surgeries.
The American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery critiqued the policy change, which makes Aetna the first major health insurer to make such a move. The policy was made effective July 1.
According to the statement, Aetna would deem less than 5 percent of cataract surgeries unnecessary.” 

Aetna, Optum call for rehearing after losing "dummy code" appellate trial: “Aetna and Optum issued a petition for a rehearing July 6 after a federal appellate court sided with a lawsuit that claimed the insurers used "dummy code" to make administrative fees appear to be billable medical charges.
In the petition, the insurers claim judges' decision to allow plaintiff Sandra Peters to sue would open the floodgates for litigation that wasn't proven to harm members. In June, judges ruled Ms. Peters did not need to provide evidence she suffered a loss to sue.”

About healthcare policy

MGMA 2021 mid-year policy update for medical groups: While focusing on medical groups, this article is a good summary of some major policy issues on the table.