Today's News and Commentary

About Covid-19

Covid-19 public health emergency extended in the US “The Biden administration on Friday extended the Covid-19 public health emergency for another three months.
US Department of Health and Human Services Secretary Xavier Becerra officially renewed the declaration, extending it through October 13, 2022.”

 White House COVID-19 coordinator says virus ‘still evolving rapidly’ “As variants continue to circulate and develop, White House COVID-19 response coordinator Ashish Jha says the U.S. has “got to stay on top of this virus” as it quickly evolves.
‘We’re still in the middle of this pandemic,’ Jha said Sunday on ABC’s ‘This Week.’
The latest COVID-19 subvariant, BA.5, is the most highly transmissible to date, Jha said. It’s also ‘immune-evasive,’ leading to high levels of reinfection and breakthrough infections. 
Vaccines are still effective at staving off severe illness, he added, but they’re not as protective against BA.5 compared to other iterations of the virus.”

WHO Advises Against Using Fluvoxamine and Colchicine for COVID-19 “The World Health Organization (WHO) has advised against the use of the antidepressant drug fluvoxamine and the gout drug colchicine for patients with mild-to-moderate COVID-19…
The panel based its advice on data from three clinical fluvoxamine trials and seven colchicine trials. Citing the lack of adequate data, the WHO did not make any recommendation on the use of the two drugs for patients with severe and critical cases of COVID-19.”

About health insurance

 CMS pitches outpatient payment rule: 5 things to know “Five takeaways from the 886-page proposed rule
1. Payment update. CMS proposed increasing OPPS rates for hospitals that meet quality reporting requirements by 2.7 percent in 2023 compared to this year. The department estimates that total payments to providers would be $86.2 billion in 2023, up $6.2 billion from 2022.
2. Inpatient only list. CMS proposed removing 10 services from the inpatient only list next year. The procedures were removed from the list in 2021 as part of the first phase of eliminating the IPO list, but they were added back to the list when the elimination process was halted last year. CMS said the codes for the maxillofacial procedures "meet the current criteria to remove services from the IPO list." 
3. 340B program. CMS said it anticipates applying a payment rate of average sales price plus 6 percent to certain drugs purchased through the 340B Drug Pricing Program. "We are still evaluating how to apply the Supreme Court's recent decision to prior calendar years," CMS said in a fact sheet.
4. Rural emergency hospitals. The proposed rule includes a payment model for rural emergency hospitals, including a monthly facility payment. "To improve access to all types of care in rural settings, CMS is broadly proposing to consider all covered outpatient department services … as REH services," CMS said. Rural emergency hospitals would be paid for providing services at a rate that is equal to the OPPS rate plus an additional 5 percent payment. 
5. Comment period. Public comments on the proposed rule are due by Sept. 13.”
See, also this CMS Fact Sheet.

Health insurance illiteracy costs employees, study finds “According to the latest Health Insurance Literacy Survey from HealthCare.com:

  • 1 in 4 Americans say lack of health insurance understanding caused them to receive a higher-than-expected medical bill.

  • Half believe that copays count toward deductibles, when they generally do not.

  • Half of respondents say they can’t afford health insurance without employer coverage.

  • 3 in 10 stay in jobs they don’t like or take jobs they don’t want so they can receive health insurance.”

About hospitals and healthcare systems

 Biden’s FTC Has Blocked 4 Hospital Mergers and Is Poised to Thwart More Consolidation Attempts “Under the FTC’s traditional economic theory, high prices in a region should attract new competitors and that competition will bring down prices. But regulatory hurdles and massive costs involved in setting up a health care network — which includes hospitals and doctors, as well other aspects like testing facilities — make such movement unlikely, if not impossible.
So Biden appointees at the FTC and Department of Justice have announced that they want to adopt some legal theories of antitrust enforcement that have been less frequently deployed…
Last December, FTC Chair Lina Khan said the agency would scrutinize how proposed mergers might affect not only prices but also workers in the labor market…
Excessive market power, she added, can allow companies to impose onerous, take-it-or-leave-it contract terms, including noncompete clauses…
The Democratic commissioners also want to take a tougher line in challenging so-called vertical mergers. In these deals, hospitals, insurers, or other types of health care companies seek to merge with or acquire companies that provide needed products, services, or staffing. One example is when hospitals or insurers acquire large physician practices, which studies have found leads to higher prices. Patients will visit a longtime physician only to find prices doubled or more, simply because the practice has been purchased by a hospital, which now sets the rates.”

About pharma

 The top 10 generic drug makers by 2021 revenue FYI

About healthcare IT

 iPad stolen from Kaiser Permanente hospital had info of 75,000 patients “The iPad included patient names, birth dates, medical record numbers and date of service information.There was no financial information or Social Security numbers in the iPad.”

About health technology

 GE Healthcare to retain its household corporate name in 2023 spinoff “General Electric took another step forward in its plan to split up its businesses among a trio of independent, publicly traded companies. It has set out a road map into early 2024 and announced the brand names of its new scions focused on medical products, aviation and energy.
In a decision that almost assuredly involved the transfer of large sums of money to market research professionals, GE Healthcare will be rechristened GE HealthCare…”

Today's News and Commentary

About Covid-19

 More than 1 in 2 Americans now live in an area where CDC urges indoor masking to curb COVID-19 surges “Fifty-five percent of the country's population now live in areas of "high" COVID-19 Community Levels, up from 32% last week, according to the CDC's weekly update. Another 30% are living in counties deemed to be ‘medium’risk.”

About health insurance

Some Medicare Part D Beneficiaries Pay Full Price for Generic Drugs “In this new assessment, Avalere finds that the share of patients paying the full cost of a generic medication placed on a preferred brand tier has increased over time. In 2020, 63% of beneficiaries across all Part D plans paid the full cost of a generic at least once, an increase of 18 percentage points from 2017 to 2020…”

 UnitedHealth Group's 13% revenue growth in Q2: 11 things to know “UnitedHealth Group saw double-digit revenue growth over the last three months driven by continued member growth under UnitedHealthcare and value-based arrangements at Optum Health, according to the company's second quarter 2022 earnings report released July 15.
UnitedHealthcare also said it would be getting rid out-of-pocket costs for some prescription drugs under fully insured group plans. Medications that will have a $0 cost-share include insulin, epinephrine, glucagon, naloxone and albuterol. Pending regulatory approvals, the policy could be in place by Jan. 1.”

Feds approve 'reinsurance' plan extension to control premiums on MNsure policies “The federal government has approved a five-year extension to Minnesota's "reinsurance" program to control premiums on health plans sold through the MNsure exchange.
In its approval application, the state Commerce Department said the program between 2018 and 2022 met its goal of a 15 to 20% average statewide reduction in premiums from what they would have been without reinsurance.
The Minnesota Premium Security Plan works by giving health insurers state-funded reimbursement for claims ranging from $50,000 to $250,000, which can stem from high-cost cases such as cancer treatments, intensive care, premature babies and severe cases of COVID-19.”

About hospitals and healthcare systems

 How Geisinger's refund program is faring amid patient experience crisis “In late 2015, the Danville, Pa.-based system rolled out the ProvenExperience program, which gives every patient the option to claim a full refund, no questions asked. The program works on a sliding scale, allowing patients to determine how much of their copay they'd like back if their service or experience expectations weren't met…
 ProvenExperience refunded $320,141 in financial year 2016. In 2020, Dr. Burke said Geisinger refunded about $84,000, and the program refunded $40,000 in 2021 — a surprising trend, given a national drop in patient experience satisfaction measures throughout the pandemic. Findings from a Press Ganey survey in November 2021 found patients' overall rating of hospital care fell 4 percentage points, and the likelihood of recommending their hospital fell 4.5 percentage points.”

HCA shares hit 1-year low “Shares of Nashville, Tenn.-based HCA Healthcare fell to a 52-week low of $164.47 in trading on July 14, according to a report from Seeking Alpha. Shares are down 24 percent over the last year and 34 percent year to date.”

About pharma

 Novo Nordisk, Eli Lilly poised to divvy up obesity market that could be worth $50B in 2030: analysts “While reimbursement and education challenges persist, drugmakers like Eli Lilly and Novo Nordisk are poised to unlock a global obesity market that could be worth more than $50 billion by the end of the decade, analysts at Morgan Stanley Research wrote in a note to clients Friday.
Novo’s latest semaglutide med, Wegovy, scored its landmark obesity nod last summer. And Eli Lilly’s tirzepatide, recently approved as Mounjaro, has big weight loss ambitions beyond its initial diabetes green light.”

About the public’s health

 The national suicide hotline is changing to 988 starting Saturday “The nationwide hotline for mental health emergencies switches to a simple 988 number on Saturday, a transition that is expected to bring millions more calls, chats and texts into a system where readiness to handle the surge varies from place to place.” 

Associations Between Prenatal Urinary Biomarkers of Phthalate Exposure and Preterm Birth “In this pooled analysis of 16 studies in the US including 6045 pregnant individuals, phthalate metabolites were quantified in urine samples collected during pregnancy. Higher urinary metabolite concentrations for several prevalent phthalates were associated with greater odds of delivering preterm, and hypothetical interventions to reduce phthalate exposure levels were associated with fewer preterm births…
Phthalates are synthetic chemicals used in everyday consumer products such as personal care items and food processing or packaging. Exposure can occur through many sources, including household dust, diet, and personal care products like cosmetics.”

Texas sues Biden over new abortion guidance as conservative groups mull more challenges “The Texas attorney general filed a lawsuit Thursday challenging new abortion guidance the Biden administration released this week — arguing that it violates the rights of doctors not to participate in terminating a pregnancy and steps on the state’s right to regulate the procedure within its borders.
The suit against the Biden administration’s top health officials only targets one of the two main actions the federal government has taken in response to the fall of Roe v. Wadea memo to hospitals and doctors across the country on Monday arguing that federal law requires them to provide abortions in emergency circumstances regardless of whatever bans their state imposes…
The Texas case will go before Judge James Hendrix, an appointee of President Donald Trump, and if appealed would go to the right-leaning 5th Circuit Court of Appeals and then up to the Supreme Court.”

Monkeypox patients should not be left to suffer when an FDA-approved drug could help More than one million doses of tecovirimat are currently sitting in the National Strategic Stockpile, with only a few doses having been released to health departments for use, even as monkeypox cases continue to rise.”
Read the article for a fascinating story about this medication.
Meanwhile: US government orders 2.5M more monkeypox vaccine doses from Bavarian Nordic via CMO

About health technology

 DOJ files False Claims Act case against dialysis giant Fresenius alleging unnecessary vascular procedures “The whistleblower complaint alleges that from about January 1, 2012 through June 30, 2018, Fresenius routinely performed certain procedures on patients with end stage renal disease (ESRD) who were receiving dialysis, without sufficient clinical indication that the patients needed the procedures. Fresenius knowingly subjected ESRD patients—who included elderly, disadvantaged minority, and low-income individuals—to these procedures to increase its revenues, the DOJ complaint states.”

Today's News and Commentary

About Covid-19

Newly Published Phase 3 Study in People with COVID-19 Shows SaNOtize Nitric Oxide Nasal Spray Reduced Viral Load by 99% within Two Days “Phase 3 trial demonstrated a reduction in SARS-CoV-2 viral load in high-risk COVID-19 patients by 94% and 99% within 24 and 48 hours of treatment, respectively
Median time to a negative PCR test was three days after beginning treatment in the nitric oxide group vs. seven days in the placebo group (P < 0.05)
Participants recruited during delta and omicron surges, suggesting antiviral properties of nitric oxide effective against evolving variants of concern”
Here is the research article.

Long-term Immune Response to SARS-CoV-2 Infection Among Children and Adults After Mild Infection “ In this cohort study of 252 family clusters with COVID-19, anti–SARS-CoV-2 spike receptor-binding domain IgG persisted until 12 months after infection in all age groups, showing significant higher antibody peaks for younger individuals at every follow-up time point. Children younger than 3 years were found to develop higher levels of binding antibodies compared with adults older than 18 years.”

About health insurance

 Are Financial Barriers Affecting the Health Care Habits of American Men? From the Commonwealth Fund: “Highlights:

  • Looking across the 11 high-income countries in our study, rates of avoidable deaths, chronic conditions, and mental health needs for U.S. men are among the highest in our analysis.

  • Men in the U.S. have the lowest rate of prostate cancer–related deaths.

  • Men in Canada, the United States, and Sweden are the least likely to have a regular doctor and have among the highest rates of emergency department use for conditions that could have been treated in a doctor’s office.

  • Men in the U.S. and Switzerland skip needed care because of costs and incur medical bills at the highest rates.

  • In the U.S., men with lower income or frequent financial stress are less likely to get preventive care, more likely to have problems affording their care, and more likely to have physical and mental health conditions.”

Profits, medical loss ratios, and the ownership structure of Medicare Advantage [MA] plans “In 2021, about 67% of enrollment in MA was accounted for by 5 large insurers: United, Humana, CVS/Aetna, Kaiser, and Anthem. These firms typically have a few related businesses that provide at least some services to their MA plans. For example, Humana owns part of “Kindred at Home,” a home health and hospice provider. Likewise, Kaiser owns Kaiser Foundation Hospitals and the Permanente Medical Groups that all contract with Kaiser MA plans. CVS/Aetna, United, and Cigna all own PBMs that contract with their MA plans. Other businesses include physician practices, pharmacies, ambulances, and dental, vision, and hearing services providers.”
The average gross margin for the top 10 companies in 2019 was 4.35%. But the article has many caveats about how difficult it is to calculate this figure, especially because of the interrelated businesses of the parent company.

Jury Convicts Man of $600 Million Health Care Fraud, Wire Fraud, and ID Theft Scheme “According to court documents and evidence presented at trial, Mathew James, 54, of East Northport, operated a medical billing company that billed for procedures that were either more serious or entirely different than those James’ doctor-clients performed. James directed his doctor-clients to schedule elective surgeries through the emergency room so that insurance companies would reimburse at substantially higher rates. When insurance companies denied the inflated claims, James impersonated patients to demand that the insurance companies pay the outstanding balances of tens or hundreds of thousands of dollars.”

Payers' underwriting earnings dropped 65% in 2021 “Six things to know:

  1. Among all payers, underwriting profits declined 65 percent to $23.9 billion.

  2. Commercial payers saw underwriting profits decrease 90 percent to $1.2 billion. This was driven by COVID-19 variant waves in the summer of 2021.

  3. Medicare Advantage plans reported a profit increase of $7.4 billion.

  4. Premiums grew in 2021 industrywide, but there was a slight decrease among group plans. That dip was offset by a major increase in individual ACA enrollment, which grew from 2.5 million to 14.5 million.

  5. Payers with diversified product portfolios weathered the decline better than those whose portfolios lacked diversity.

  6. Despite the pandemic impact, U.S. payers recorded record capital and a surplus of $273 billion for 2021, a 13.5 percent increase year over year.”

Health insurance status and cancer stage at diagnosis and survival in the United States “Compared with privately insured patients, Medicaid-insured and uninsured patients were significantly more likely to be diagnosed with late-stage (III/IV) cancer for all stageable cancers combined and separately. For all stageable cancers combined and for six cancer sites—prostate, colorectal, non-Hodgkin lymphoma, oral cavity, liver, and esophagus—uninsured patients with Stage I disease had worse survival than privately insured patients with Stage II disease. Patients without private insurance coverage had worse short-term and long-term survival at each stage for all cancers combined; patients who were uninsured had worse stage-specific survival for 12 of 17 stageable cancers and had worse survival for leukemia and brain tumors. Expanding access to comprehensive health insurance coverage is crucial for improving access to cancer care and outcomes, including stage at diagnosis and survival.”

About pharma

 Theravance cashes in Trelegy Ellipta royalty rights for $1.1 billion upfront “Theravance Biopharma announced that it entered into a definitive agreement to sell its royalty rights on global net sales of GSK's asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to Royalty Pharma for over $1.5 billion, including an upfront cash payment of around $1.1 billion. The transaction is expected to close in the next 10 business days.”

Bayer offloads Nebido as part of pharma unit transformation “Bayer agreed to sell its male hypogonadism treatment Nebido (testosterone undecanoate) to Grünenthal for up to €500 million as the German drugmaker continues to focus on its key areas of innovation. Last year, the long-acting injectable generated sales of €117 million.”

Judge Approves $264 million Mylan/Viatris Settlement Over High EpiPen Prices “Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions.”

Alnylam Sues Pfizer, BioNTech and Moderna Again Over Alleged Patent Infringement “Alnylam Pharmaceuticals has filed new complaints against Pfizer-BioNTech and Moderna over alleged patent infringement of its biodegradable lipids, which the company claims are essential to the safety and efficacy of the companies’ messenger RNA-based COVID-19 vaccines.
Alnylam previously filed suit against the companies in March for alleged infringement of its patented lipid nanoparticle technology. In the new complaint, which cites a different patent, Alnylam said the lipid technology is used to help prevent the rapid degradation of the vaccines upon administration.”

Few biopharma risers stand out at the half year “Only a fifth of the 660 global drug developers tracked by Evaluate Vantage ended June in positive territory. Among the winners Lantheus stands out as the only stock to produce a triple-digit gain, excluding takeover targets, while Covid fatigue caused valuations at the big pandemic plays to continue ebbing away.
Pfizer, Moderna, Biontech, Novavax and Curevac registered some of the biggest declines in their respective market cap brackets. Covid is far from over, but questions about the durability of revenues from vaccines and other treatments is causing investors to look for new growth stories.”
Read the article for details by company.

About the public’s health

 Studies Probe Adenovirus Link to Childhood Hepatitis Cases “Two new studies, published in the New England Journal of Medicine on Wednesday, report that two medical centers — one in Birmingham, Ala., and another in Birmingham, England — have seen increases in the number of children with acute, unexplained hepatitis in recent months.
The research also presents more circumstantial evidence that adenovirus 41, which often causes gastrointestinal symptoms, may be a contributing factor. In both studies, adenovirus infections were detected in about 90 percent of children tested, and children who developed acute liver failure or required transplants had higher average levels of the virus in their blood than those with milder cases.”

About health technology

 Illumina loses challenge to block EU antitrust probe into $8B Grail buyout “Fighting to push its $8 billion acquisition of Grail past European regulators, Illumina suffered a key setback Wednesday when an EU court ruled an antitrust probe into the buyout can proceed.Illumina was challenging the inquiry after the EU objected to the acquisition over concerns it would concentrate most available genetic sequencing tests under one roof. The company has said it would appeal the ruling to Europe’s highest court…, but the bloc’s antitrust group may not wait for that process — which could take years — to wrap up before deciding whether to block the deal.” 

Today's News and Commentary

About Covid-19

 Biden Administration to Again Extend the Covid Public-Health Emergency “The Department of Health and Human Services has repeatedly renewed the emergency since it was originally declared in January 2020, with the most recent extension set to expire July 15. The next extension is expected to take effect Friday, according to a person familiar with the matter who asked not to be identified because the details aren’t public.” 

Moderna to advance two Omicron vaccine candidates against newer variants “Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5.”

About health insurance

Optum, Red Ventures partner on consumer healthcare platform “UnitedHealth Group's provider arm, Optum Health, has teamed up with Red Ventures on a new consumer health-focused joint venture, RVO Health, which among other things includes doctor ratings through Healthgrades.
Red Ventures is a portfolio of bands that includes Healthgrades, Healthline Media, Optum Perks and Optum Store, as well as virtual coaching programs. Those will all be folded into the RVO Health venture.
According to a report from Moody's Investors Service, RVO Health will combine 120 million UHG customers and 50 million-plus members with Red Ventures' 95 million unique monthly visitors.”

About hospitals and healthcare systems

 HHS clarifies: All US hospitals must provide abortions in emergency cases “HHS issued guidance to hospitals July 11 to clarify that abortion is covered under the federal law requiring Medicare hospitals to provide all patients appropriate emergency care — including abortion care — regardless of state law…
The Emergency Medical Treatment and Labor Act was enacted in 1986 by Congress to require that Medicare hospitals provide all patients an appropriate emergency care — including medical screening, examination, stabilizing treatment and transfer, if necessary — irrespective of any state laws or mandates that apply to specific procedures. If a hospital is in a state that prohibits abortion by law and does not make exceptions for the health or life of a pregnant person, EMTALA preempts that state law.
HHS enforces EMTALA through CMS and a complaint-driven process.”

About pharma

 FDA to review first ever over-the-counter birth control pill “Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception…
The contraceptive is currently a prescription drug sold under brand Opill.
HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023…”
And in a related article: Oral Contraceptives, Hormone Replacement Therapy, and Stroke Risk “Millions of women worldwide use exogenous hormones as oral contraceptives or hormone replacement therapy. Still, time-dependent and long-term consequences of exogenous hormones on stroke risk remains unclear…
Oral contraceptive use and hormone replacement therapy were associated with an increased risk of stroke, especially during the first year of use, possibly due to immediate changes in hemostatic balance. This study provides new insights on the effects of hormone exposure on stroke risk and provide evidence of not only an overall risk but also a pronounced effects seen in the beginning of treatment.”

Robert Califf Sounds Alarm if User Fees Aren’t Reauthorized Quickly ”Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee reauthorization package by August.”

Merck sues HHS to avoid fine over 340B contract pharmacy restrictions “The pharmaceutical giant argues in a federal lawsuit filed Friday in the U.S. District Court for the District of Columbia that favorable rulings in similar cases make a warning letter from the federal government moot. The lawsuit is the latest in a feud between the federal government and drugmakers over the 340B program.”

Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials “Conventionally, clinical trials have a defined end and only compare pre-specified intervention(s), meaning that therapeutic discoveries made during the trial are evaluated in a new trial. This results in multiple independent trials, requiring new infrastructure for each shorter-term evaluation and more patients randomized to placebo or standard-of-care compared with platform trials.
Platform trials are randomized clinical trials that allow for multiple interventions to be simultaneously compared and new interventions to be added after the trial is initiated. They typically aim to continue for an extended period or in perpetuity with interventions entering and leaving the platform at different times. Many published reviews on platform trials describe the statistical efficiencies of platform trials over conventional trial approaches. There is little guidance, however, on substantive resources to establish and maintain platform trials…
The findings of this study suggest that despite having larger initial setup requirements, consolidating clinical evaluation of multiple interventions into a single platform trial can drastically reduce cost and efforts.”
Also, see: An Economic Perspective on Platform Trials—The Gift and the Curse

About the public’s health

 Superbug infections spiked in pandemic's first wave “The first wave of the Covid pandemic created the perfect storm for superbugs in the U.S., with cases and deaths from dangerous drug-resistant bacterial and fungal infections spiking in hospitals in 2020, a report published Tuesday finds. 
The spike, the Centers for Disease Control and Prevention report said, wiped out the progress made against the deadly pathogens before the pandemic.”

About healthcare IT

 Machine Learning Analysis of Handgun Transactions to Predict Firearm Suicide Risk “In this prognostic study of nearly 2 million individuals with handgun transaction records, among transactions classified in the riskiest 5%, close to 40% were associated with a purchaser who died by firearm suicide within 1 year. Among the small number of transactions with a random forest score of 0.95 and above, more than two-thirds were affiliated with a purchaser who died by firearm suicide within 1 year (24 of 35).”
Fascinating, but the gun lobby will never let this technology achieve widespread acceptance. 

Epic's revenue up 13% in 2021, hit $3.8B “Epic reported a 15 percent annual growth rate for the decade leading up to last year and then saw 13 percent revenue growth to $3.8 billion.”

About health technology

 Medtronic begins Class I recall of 1 million dialysis catheters at risk of leaking “Medtronic has asked healthcare providers to immediately stop using more than 1 million catheters distributed across the U.S. and around the world after discovering a potential safety risk within the devices.
The alert marks the latest Class I recall for a company that has racked up half a dozen such safety events since the start of the year. The FDA dished out its most serious classification to the catheter recall last week, about a month after Medtronic initiated it in early June.”

Philips scores FDA clearance for faster MRI scanning powered by AI “Philips has secured an FDA clearance for artificial-intelligence-powered software designed to speed up the MRI scanning process while still delivering high-resolution images. 
Dubbed SmartScan, Philips said the program can help complete scans up to three times faster with ‘virtually no loss in image quality,’ allowing radiology departments to see more patients with the same hardware in about 97% of cases.
That covers a wide range of clinical protocols including the use of injected contrast agents as well as diffusion weighted imaging and quantitative scans of the brain, liver, heart and musculoskeletal system. It is also compatible with implants and can capture organs in motion or even a restless patient.”

Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression “Abbott said Tuesday that it has earned the agency’s acknowledgement for an ongoing project to apply its deep brain stimulation system to treatment-resistant depression. The label gives the technology a more expedited pathway toward potential FDA clearance.”

CEO of Dozens of Companies and Entities Charged in Scheme to Traffic an Estimated $1 Billion in Fraudulent and Counterfeit Cisco Networking Equipment “According to the indictment, Onur Aksoy, aka Ron Aksoy, aka Dave Durden, 38, of Miami, allegedly ran at least 19 companies formed in New Jersey and Florida as well as at least 15 Amazon storefronts, at least 10 eBay storefronts, and multiple other entities (collectively, the ‘Pro Network Entities’) that imported tens of thousands of fraudulent and counterfeit Cisco networking devices from China and Hong Kong and resold them to customers in the United States and overseas, falsely representing the products as new and genuine. The operation allegedly generated over $100 million in revenue, and Aksoy received millions of dollars for his personal gain.”

Today's News and Commentary

About Covid-19

 Biden-Harris Administration secures 3.2 million doses of Novavax COVID-19 Vaccine “The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD)…announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC)…
The Novavax COVID-19 Vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune system response to vaccine.”

Boston researchers may have found biomarker for long COVID

  1. “Researchers have found the SARS-CoV-2 spike protein circulating in the blood of long COVID-19 patients up to 12 months after they were diagnosed, The Boston Globe reported.

  2. The scientists said the findings suggested the spike protein was a potential biomarker that could be helpful in diagnosing and treating long COVID patients.

  3. ‘Strikingly, we detect SARS-CoV-2 spike antigen in a majority of [long COVID] patients up to 12 months post-diagnosis, suggesting the presence of an active persistent SARSCoV-2 viral reservoir,’ the study said.

  4. Meanwhile, the spike antigen was not detected in patients who recovered from COVID-19 but did not get long COVID.

  5. Senior author David Walt said the results suggest that ‘if someone could somehow get to that viral load and eliminate it, it might lead to resolution of symptoms.’”

About hospitals and healthcare systems

 Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019 “In this serial cross-sectional study of 244 542 adult patients hospitalized in 3156 US hospitals from 2010 to 2019, there were statistically significant decreases in the annual rates of in-hospital adverse events for admissions for acute myocardial infarction (annual adjusted relative risk [RR], 0.94), heart failure (RR, 0.95), pneumonia (RR, 0.94), major surgical procedures (RR, 0.93), and all other conditions (RR, 0.97).” 
Despite these improvements, as the accompanying editorial (Improvements in Hospital Adverse Event Rates) notes: “the report by Eldridge and colleagues on a decade of hospital trends is an unfortunate reminder that adverse events remain unacceptably frequent.”

About pharma

FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs “After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in late June that would make it easier for pharmaceutical companies to switch products from prescription-only to over-the-counter status while still retaining a prescription version.
Under the rule, patients would enjoy access to medications that previously required an office visit and a prescription, while payers would reap the financial benefits of fewer medical and prescription claims. Whether the change would be a challenge or an opportunity for pharmacies depends entirely on how the rule is implemented. [Comment: And relative charges.]
Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart.
What the rule does not do is create a third class of drugs that would not require a prescription yet, instead of being available over the counter, would be ‘behind-the-counter’ and could be purchased only after consulting with a pharmacist. The possibility of this third class has been in play since 2012.”

 Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder [MMD] “In this randomized clinical trial that included 1944 patients with MDD, provision of pharmacogenomic tests for drug interactions compared with usual care resulted in prescriptions with no predicted drug-gene interactions in 45% vs 18%, respectively, a difference that was statistically significant. Remission of symptoms reached a maximum difference of 16.5% vs 11.2% at 12 weeks but was not significantly different at 24 weeks.”
Is genome sequencing valuable for preventing drug-drug interactions or improving targeted treatments? The answer varies with different drugs and illnesses. 
See the accompanying editorial: Pharmacogenomic Testing for Next-Step Antidepressant Selection

About the public’s health

 Spirituality in Serious Illness and Health Question  How can considerations of spirituality guide health care and health outcomes?…
The serious illness Delphi expert panel review identified 8 findings, as enumerated: (1) spirituality is important to most patients with serious illness (eg, literature estimates ranged from 71%-99%); (2) spiritual needs are common in that setting (eg, estimates ranged from 23%-98%); (3) spiritual care is frequently desired by patients with serious illness (eg, estimates ranged from 50%-96%); and (4) spirituality can influence medical decision-making in serious illness. Despite these findings, (5) spiritual needs of patients with serious illness are frequently unaddressed within medical care, especially since (6) spiritual care is infrequent in the care of such patients (eg, estimates of patients not receiving spiritual care ranged from 49%-91%). Findings noted that (7) the provision of spiritual care in the medical care of patients with serious illness was associated with better end-of-life outcomes, while (8) unaddressed spiritual needs can be associated with poorer patient quality of life.”
Look at the definitions and Tables 4 and 5.

Apgar scores are less predictive of infant mortality for Black babies than white ones, study finds ”The study, published Tuesday in PLOS Medicine, found that more Black infants were assigned low Apgar scores than white infants and that the scores were better at predicting death in the first year of life in white infants compared with Black babies.”

Today's News and Commentary

About Covid-19

 About 300,000 children under 5 have received at least one Covid-19 shot, White House says The headline should probably start with the word “Only.”

COVID-19 hospitalizations hit highest national average since March “COVID-19 hospitalizations have steadily increased to reach the highest national average since early March, with more than 33,000 people in U.S. hospitals with coronavirus on a given day.
Hospitalizations are up 18 percent nationwide over the past 14 days, with a daily average of 37,472 people hospitalized with COVID-19 as of July 11, according to HHS data…”

Covid-19 reinfections may increase the likelihood of new health problems “Repeatedly catching Covid-19 appears to increase the chances that a person will face new and sometimes lasting health problems after their infection, according to the first study on the health risks of reinfection.
The study, which is based on the health records of more than 5.6 million people treated in the VA Health System, found that, compared with those with just one Covid-19 infection, those with two or more documented infections had more than twice the risk of dying and three times the risk of being hospitalized within six months of their last infection. They also had higher risks for lung and heart problems, fatigue, digestive and kidney disorders, diabetes and neurologic problems.”

Repeat Dosing of Evusheld Recommended for Ongoing COVID-19 Protection “The Food and Drug Administration (FDA) has revised the fact sheet for Evusheld™(tixagevimab co-packaged with cilgavimab) to include a recommendation for repeat dosing every 6 months for the preexposure prophylaxis of COVID-19.
Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein. The product is authorized for emergency use for individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, and:

  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or

  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).”

About health insurance

 2023 employer health and benefit strategies focused on affordability and access, Mercer survey “The survey found that 70% of all large employers are planning benefit enhancements for 2023.
While small employers are somewhat less likely to be planning enhancements, still, more than half (53%) say that they are…
When asked whether benefits enhancements would be targeted to specific employee groups, about a fifth of large employers say they are focusing on their hourly and low- wage workers…
While hourly workers are the group most likely to be singled out for special attention across all industries, highly skilled workers are the priority for large health care employers (24%).”
This short report is well worth at least a quick look.

Association Between Self-reported Health-Related Social Needs and Acute Care Utilization Among Older Adults Enrolled in Medicare Advantage “To what extent are self-reported health-related social needs (HRSNs) associated with acute care utilization among older adults enrolled in Medicare Advantage, and are there specific HRSNs that seem to matter more?
Findings  In this cross-sectional study of 56 155 older adults enrolled in Medicare Advantage, HRSNs were associated with statistically significantly higher rates of acute care utilization, with the largest association observed for avoidable hospital stays (53.3% increase). Unreliable transportation had the largest association with hospital stays and emergency department visits (marginal effects of 51.2 and 95.5 events per 1000 beneficiaries, respectively).”

UnitedHealth accused of underpaying for telehealth “The lawsuit, filed in federal court in Connecticut on Thursday by a Chicago woman using the pseudonym CP, seeks to represent a class of "at least hundreds and likely thousands" of beneficiaries of UnitedHealth insurance plans covered by the federal Employee Retirement Income Security Act (ERISA).”
The claim is that United paid at a rate based on an old Medicare rate instead of the updated telehealth rate based on parity with in-person visits.

Surprise Medical Bills Have Been Banned Since January. 1 in 5 Americans Say They or Their Family Have Gotten an Unexpected Charge Anyway

  • “20% of adults said they or their family have received an unexpected medical bill this year, and 22% of them were charged over $1,000.

  • 45% of adults said they are confident they would know their emergency room bill up front.

  • 63% of adults said they’re confident they would be able to address a surprise bill that they believed to be illegal with a provider or insurer.”

CMS proposes slight doc pay cut in 2023 and several reforms to ACOs, dental service coverage “CMS proposed a 2023 fee schedule conversion factor of $33.08 for each relative unit, which determines how Medicare payments to doctors are calculated. That factor is a slight decline of the 2022 factor of $34.61. 
The factor considers a statutory requirement that the conversion factor for 2023 remains flat and the expiration of a 3% bump in fee schedule payments that went away in 2022. The slight bump was installed to help physicians weather the revenue impact from the COVID-19 pandemic. 
The fee schedule must also be budget neutral under federal law.
In addition to the payment changes, CMS is proposing to expand the dental services that would get coverage from Medicare. Currently, Medicare only pays for certain treatments such as reconstruction of a jaw after an injury or tooth extraction following cancer care. 
Now, CMS proposed to also pay for a dental exam and treatment preceding an organ transplant as well as several other services. The agency also wants comments on what else Medicare should reimburse for dental services…
CMS also proposed several major changes to the Medicare Shared Savings Program (MSSP) that oversees ACOs. Chief among them is a proposal to install a health equity adjustment of up to 10 bonus points to the ACO’s Merit-based Incentive Payment System (MIPS) quality performance score. The equity adjustment would only positively impact an ACO but not penalize them, CMS said in a release…
CMS is proposing that an organization new to MSSP which is not renewing or reentering as an ACO and qualifies as low revenue can get a one-time payment of $250,000 and quarterly payments for the first two years of a five-year period.”

About pharma

Amid drug pricing debate, feds reveal plan to crack down on 'incremental' patents “Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office (PTO) are teaming up to take a close look at patenting procedures… [T]he PTO said it plans to crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify" for new protections.”

Certain discarded drugs will soon cost pharma companies “According to an infrastructure bill passed last year, drug manufacturers must refund Medicare for unused drugs in single-dose vials beginning in 2023. Medicare also included the update in its latest proposed rule…
Back in 2020, Medicare paid nearly $720 million for discarded drugs paid under Part B, the agency said in its proposal. That’s on par with prior years dating back to 2017, when Medicare shelled out between $700 million and $750 million per year for discarded drugs.
A large portion of those unused drugs were ones dosed based on a patient’s body weight or surface area. When a patient’s dose is drawn from more than one vial, any remaining drug must be discarded.
The mandate applies only to single-dose vials or single-use packaged drugs — not to radiopharmaceutical or imaging agents, certain drugs that require filtration, or ‘certain new drugs,’ according to Medicare. And the amount of discarded drugs must be higher than 10% to get a refund.”

 Newsom announces California will produce its own ‘low cost’ insulin “Newsom said that the state budget he recently signed includes $100 million for California to ‘contract and make [its] own insulin at a cheaper price, close to at cost, and to make it available to all.’
He said $50 million of that budget will go to the development of the low cost insulin, while the additional $50 million will go toward a California-based manufacturing facility for the drug, which Newsom claims ‘will provide new, high-paying jobs and a stronger supply chain.’
Newsom also noted in his announcement that he had signed an executive order his first day in office to put California on the path to creating its own prescription drugs, touting that ‘now it’s happening.’” 

About the public’s health

Childhood Obesity Rate in the U.S. Higher Now Than 12 Years Prior “The researchers noted a 4.5 percent relative increase in the cumulative incidence of new obesity cases by the end of fifth grade across cohorts among children who did not have obesity at kindergarten entry (15.5 versus 16.2 percent), although no substantial change was seen in annual incidence. For children who had a normal body mass index at kindergarten entry, the risk for incident obesity stayed the same, while the risk for incident obesity increased slightly among overweight kindergarteners. There was an expansion of social disparities in obesity incidence: A 29 percent increase was seen in the incidence of new cases during primary school among non-Hispanic Black children, while the risk stayed stable or decreased for other race-ethnic groups. A 15 percent higher cumulative incidence was seen across primary schools in 2010 versus 1998 for children from the most socioeconomically disadvantaged households.”

Monkeypox cases rise 77% in UN agency's latest weekly count

  • The World Health Organization (WHO) on Thursday reported a 77% weekly increase in the number of lab-confirmed monkeypox cases, to more than 6000 worldwide, as well as two more deaths in parts of Africa…

  • Most of the cases were reported in Europe and Africa. The agency said the outbreak continues to mainly affect men who have had sex with men, and that other population groups showed no signs of sustained transmission.

  • The WHO said it counted 6027 laboratory-confirmed cases of monkeypox from 59 countries as of Monday, an increase of 2614 cases since its last count for the week that ended June 27. It added that three people have now died in connection with the outbreak, all in Africa.

  • It noted that nine additional nations had reported cases, while 10 countries had not reported any new cases for more than three weeks, which is the maximum incubation period.

  • WHO Director-General Tedros Adhanom Ghebreyesus said he remained ‘concerned by the scale and spread of the virus,’ noting that more than 80% of the cases turned up in Europe. He said he plans to convene the next meeting of a WHO expert panel that is monitoring the outbreak for no later than the week of July 18.”

Biden signs order on abortion access after Supreme Court ruling “Biden formalized instructions to the Departments of Justice and Health and Human Services to push back on efforts to limit the ability of women to access federally approved abortion medication or to travel across state lines to access clinical abortion services.”

About healthcare IT

 Teladoc adds medication delivery, in-home phlebotomy to primary care service Primary360 “Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.”

Today's News and Commentary

About Covid-19

FDA allows licensed pharmacists to prescribe Pfizer's Paxlovid under certain conditions “The US Food and Drug Administration revised the emergency use authorization for Pfizer's Covid-19 antiviral treatment, Paxlovid, on Wednesday to allow state-licensed pharmacists to prescribe the treatment to people who are eligible.” So far, so good. However: “Those who want to get Paxlovid from a pharmacist need to have with them electronic or printed health records that are less than 12 months old and that include blood work to review for kidney or liver problems, as well as a list of all medications being taken, both over-the-counter and prescription, to screen for drug interactions. The health records could also be obtained through a consult between the pharmacist and a person's health care provider.”

About health insurance

 Health Care Fraud and Abuse Control [HCFAC] Program Annual Report for Fiscal Year 2021 “During the fiscal year, the Federal Government won or negotiated more than $5.0 billion in judgments and settlements and attained additional administrative impositions in health care fraud casesandproceedings.9 Becauseoftheseefforts,aswellasthoseofprecedingyears,almost $1.9 billion was returned to the Federal Government or private persons. Of this $1.9 billion, the Medicare Trust Funds received transfers of approximately $1.2 billion during this period; approximately $98.7 million in federal Medicaid money was transferred to the Centers for Medicare & Medicaid Services separately due to these efforts.
In addition to these enforcement actions, numerous audits, evaluations, and other coordinated efforts yielded recoveries of overpaid funds and prompted changes in federal health care programs that reduce vulnerability to fraud.
The return on investment (ROI) for the HCFAC program over the last three years (2019–2021) is $4.00 returned for every $1.00 expended. Because the annual ROI can vary from year to year depending on the number and type of cases that are settled or adjudicated during that year, DOJ and HHS use a three-year rolling average ROI for results contained in the report.”

Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries “Enrollees were offered 12 months of social needs case management, which provided more intensive services to patients with higher demonstrated needs…
Participants in the intervention group visited the ED at ratios of 0.96 (95% CI, 0.91 to 1.00) for all visits and 0.97 (CI, 0.92 to 1.03) for avoidable visits relative to the control group. The intervention group was hospitalized at ratios of 0.89 (CI, 0.81 to 0.98) for all admissions and 0.72 (CI, 0.55 to 0.88) for avoidable admissions…
Although social needs case management programs may reduce health care use, these savings may not cover full program costs. More work is needed to identify ways to increase patient uptake and define characteristics of successful programs.”

About hospitals and healthcare systems

 Risk of Closure Among Independent and Multihospital-Affiliated Rural Hospitals “In this 13-year cohort study from 2007 to 2019 among rural US hospitals that faced financial distress in 2007, affiliation was associated with a lower risk of closure compared with being independent. Conversely, among hospitals with financial stability in 2007, affiliation was associated with a higher risk of closure compared with being independent.” 

About pharma

 Hospitals and for-profit PBMs are diverting billions in 340B savings from patients in need An excellent review of this program.

About the public’s health

 Disposable Hospital Gowns Could Expose Health Workers to Infection “Disposable gowns designed to deflect the splatter of bodily fluids, used in thousands of U.S. hospitals, have underperformed in recent and ongoing laboratory tests and may fall short of safety standards, leaving health care workers with a greater risk of infection than advertised.
A peer-reviewed academic study, published to little notice amid the coronavirus pandemic, found that isolation gowns commonly worn in medical units or intensive care units ripped too easily and allowed about four to 14 times the expected amount of liquid to seep through when sprayed or splashed.”

CMS Innovation Center Tackles Implicit Bias “The assessment focused on three established models: the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model, and Million Hearts® Cardiovascular Risk Reduction Model
The assessment examined three models to identify potential sources of bias and found that use of certain risk-assessment and screening tools, provider tools, and payment design and risk-adjustment algorithms has led to the exclusion of some beneficiaries from these models. These findings are troubling not only because of the limited access to the benefits of Innovation Center models but also because diverse model participation is critical for robust evaluation and confidence in generalizing results to all of the populations served through CMS programs.
As described above, the Innovation Center has taken initial actions to address these sources of bias for ongoing models; however, the findings underscore the need for a more systematic evaluation of implicit bias in current and new models.

About healthcare IT

 Major payment vendor data breach, North Korean threat raise ransomware concerns for hospitals “A recently disclosed ransomware attack at a payment vendor [Northern Colorado-based debt collections firm Professional Finance Company] could have exposed patient data from more than 650 healthcare providers, including those at Arizona-based nonprofit Banner Health and Nevada physician network Renown Health.
While the exact number of patients affected is unclear, it could be one of the biggest healthcare data breaches this year given the extensive network of providers involved.
In addition, the federal government issued an advisory Wednesday warning healthcare and public health organizations that North Korea government-sponsored hackers have been targeting the industry using a particular form of ransomware for the past year.”

Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials “In this cross-sectional survey study of 1183 patients with cancer and survivors of cancer, self-reported patient disposition toward enrollment in cancer clinical trials increased for modifications using remote technology and other decentralization tools. The majority of respondents (60%-85%) reported being more likely to enroll if the participation-related time and travel burden decreased as a result of these practices.”

About healthcare personnel

 Job Cuts Surge in June 2022, Up 57% From May, 59% From June 2021; Highest Quarterly Total Since Q1 2021  “Health Care/Products manufacturers and providers announced the most job cuts this year with 19,390, up 54% from the 12,620 announced through June 2021.” 

About health technology

Former Theranos executive Sunny Balwani convicted on 12 fraud counts “Former Theranos executive Ramesh “Sunny” Balwani, who long served as the second-in-command to founder Elizabeth Holmes, was convicted of all 12 counts in federal court in San Jose for defrauding investors and patients connected to the biotech company, according to the Associated Press.”

Groundbreaking Alzheimer's Treatment Study Fascinating science! Read the entire article.

How A Shortage of Plastic Is Impacting Health Care “It’s been a years-long challenge. Prior to the pandemic, prices for raw material plastics were relatively stable... Then Covid led to an increase in demand for manufactured goods. And intense storms in 2021 damaged some of the American oil refineries that are at the beginning of the plastic supply chain, decreasing production and increasing prices…
 Baxter International Inc. makes machines that hospitals and pharmacies use to mix different sterile liquids together. But one plastic component of the machines was in short supply, the company said in an April letter to health care providers…
[Also] the resin shortage was affecting multiple product lines at the end of June, including blood collection, laboratory and respiratory products.”

Today's News and Commentary

About Covid-19

 Nanoparticle Vaccine Protects Against a Spectrum of COVID-19-causing variants and Related Viruses “Betacoronaviruses, including those that caused the SARS, MERS, and COVID-19 pandemics, are a subset of coronaviruses that infect humans and animals. The vaccine works by presenting the immune system with pieces of the spike proteins from SARS-CoV-2 and seven other SARS-like betacoronaviruses, attached to a protein nanoparticle structure, to induce the production of a broad spectrum of cross-reactive antibodies. Notably, when vaccinated with this so-called mosaic nanoparticle, animal models were protected from an additional coronavirus, SARS-CoV, that was not one of the eight represented on the nanoparticle vaccine.”

COVID-19 Vaccination Activates Antibodies Targeting Parts of Virus Spike Protein Shared Between Coronaviruses “Could the SARS-CoV-2 vaccine reawaken previous antibody responses and point the way to a universal coronavirus vaccine? A new analysis of the antibody response to a COVID-19 vaccine suggests the immune system’s history with other coronaviruses, including those behind the common cold, shapes the patient’s response, according to a study published today in Cell Reports
Led by scientists at the Translational Genomics Research Institute (TGen), part of City of Hope, and Northern Arizona University (NAU), a research team found that the vaccine generates antibodies that target regions of the SARS-CoV-2 spike protein that are unique to the new virus, while also targeting regions of the protein that are shared or conserved among many coronaviruses. 
What’s more, the antibody response to these different coronaviruses appears to follow different paths. Over the course of 140 days following vaccination, the response to common cold coronaviruses started early but diminished over time. The response to SARS-CoV-2 continued to get stronger and stronger over time.”

About health insurance

Claims Denials and Appeals in ACA Marketplace Plans in 2020 “We find that, across HealthCare.gov insurers with complete data, about 18% of in-network claims were denied in 2020. Insurer denial rates varied widely around this average, ranging from less than 1% to more than 80%.
CMS requires insurers to report the reasons for claims denials at the plan level. Of denials with a reason other than being out-of-network, about 16% were denied because the claim was for an excluded service, 10% due to lack of preauthorization or referral, and only about 2% based on medical necessity. Among 2% of claims identified as medical necessity denials, 1 in 5 were for behavioral health services. Most plan-reported denials (72%) were classified as ‘all other reasons’, without a specific reason.
As in our previous analysis of claims denials, we find that consumers rarely appeal denied claims and when they do, insurers usually uphold their original decision. In 2020, HealthCare.gov consumers appealed just over one-tenth of 1% of denied in-network claims, and insurers upheld most (63%) of denials on appeal.”


Children's Uninsurance Fell between 2019 and 2021, but Progress Could Stall When Pandemic Protections Expire From The Urban Institute: “We find the following:

  • Children’s uninsurance rates were relatively stable between early 2019 and early 2021, according to both the NHIS and the CPS [National Health Interview Survey and the Current Population Survey]. Recent NHIS data suggest a decline in uninsurance among children between early and late 2021; no data are yet available for this period from the CPS.

  • Overall, the NHIS indicates a decline in the annual uninsurance rate among children from 5.1 percent in 2019 to 4.1 percent in 2021, which translates to about 700,000 fewer uninsured children.

  • Both survey and administrative data sources suggest public coverage increased among children between early 2019 and early 2021.

    • The NHIS indicates a significant 4.9 percentage-point increase in public coverage and a roughly corresponding decline in private coverage over the period.

    • Changes in coverage on the CPS are much smaller in magnitude and not statistically significant but suggest offsetting public coverage gains and private coverage losses between March 2019 and March 2021.

    • Administrative data show that approximately 4 million more children were enrolled in Medicaid/CHIP in March 2021 than in March 2019.

  • Administrative data indicate further gains in Medicaid/CHIP and Marketplace enrollment among children between early 2021 and early 2022.”

Drivers of 2023 Health Insurance Premium Changes From the American Academy of Actuaries: “Key Points

  • Although COVID-19-related costs may be more predictable and
    the worst days of the pandemic appear to be over, there is still uncertainty regarding whether new variants will evade immunity and cause a resumption in more serious health problems.

  • The expiration of the ARPA enhanced premium subsidies will likely cause a decline in enrollment and a worsening of the risk pool, leading to higher premiums.

  • Medicaid redeterminations could cause an influx of people into the individual market, potentially improving the risk pool and lowering the premiums somewhat. Any effects would

    be less than those caused by the expiration of ARPA subsidies.

  • Inflation may have some effect on provider costs, but because provider payments lag inflation, real effects might not occur until later plan years. Nevertheless, workforce shortages could put upward pressure on provider payment rates.”

About hospitals and healthcare systems

 The Best Hospitals in America Yet another ranking. This one from Money magazine and the Leapfrog Group.

About pharma

 AstraZeneca to shell out $1.27B for biotech company TeneoTwo “Pharmaceutical company AstraZeneca has offered up to $1.265 billion to acquire TeneoTwo and the biotech company's lymphoma research currently in a phase 1 trial. 
In a July 5 press release, AstraZeneca said TeneoTwo's ‘promising" T-cell engager is designed to redirect the immune system to "recognize and kill cancer cells.’”

After its own vaccine flop, CureVac sues Pfizer partner BioNTech for patent infringement “A year after a high-profile flop with its COVID-19 vaccine candidate, CureVac is still trying to get a piece of the action.
On Monday, the company revealed that it is suing fellow German mRNA pioneer BioNTech for infringement of its intellectual property by developing the Pfizer-partnered COVID shot Comirnaty.
CureVac said it has no intention of disrupting the production, sale or distribution of BioNTech's megablockbuster vaccine with an injunction. Instead, the Tubingen-based company wants recognition and compensation for the technology it developed—beginning with work more than two decades ago—which it says was essential in BioNTech’s creation of its successful shot.”

About the public’s health

Labcorp launches monkeypox PCR tests through CDC initiative “…Labcorp announced Wednesday that it will begin testing for the viral disease using the CDC’s orthopoxvirus test, which Labcorp helped validate for the agency. The PCR test is designed to detect all non-smallpox-related orthopoxviruses, a group that includes cowpox, horsepox and camelpox, along with monkeypox.”

FDA temporarily suspends order banning Juul cigarettes “The Food and Drug Administration issued an administrative stay Tuesday on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market.
The agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.”

Trends and Disparities in Cardiometabolic Health Among U.S. Adults, 1999-2018 Between 1999 and 2000 and 2017 and 2018, U.S. cardiometabolic health has been poor and worsening, with only 6.8% of adults having optimal cardiometabolic health, and disparities by age, sex, education, and race/ethnicity. These novel findings inform the need for nationwide clinical and public health interventions to improve cardiometabolic health and health equity.”

About healthcare IT

  Watson Health, under new investment firm ownership, is reborn as Merative “Investment firm Francisco Partners celebrated the close of its IBM Watson Health assets acquisition by announcing the launch of a new standalone data analytics company.
Called Merative, the Ann Arbor, Michigan-based business aims to offer its health data services to clients ranging from providers, health plans and employers to life sciences firms, imaging companies and government entities, according to the announcement.” 

 Machine Learning–Based Models Incorporating Social Determinants of Health vs Traditional Models for Predicting In-Hospital Mortality in Patients With Heart Failure “In this cohort study, ML models developed in the Get With The Guidelines–Heart Failure (GWTG-HF) registry using race-specific and race-agnostic approaches were associated with an improvement in the prediction of in-hospital mortality after hospitalization for HF compared with the existing and rederived logistic regression models. The addition of SDOH was associated with an improvement in the performance and prognostic utility of the ML models in Black patients but not in non-Black patients.”

About healthcare personnel

 HHS awards more than $155M for primary care training expansion “The HHS announced more than $155 million in awards for primary care and dental residency programs through the Health Resources and Services Administration, or HRSA.”

Today's News and Commentary

About Covid-19

 NYC to skirt pharmacies, hand out Paxlovid prescriptions at mobile test-to-treat sites The headline is the story.

About health insurance

Use and Cost of Low-Value Health Services Delivered or Paid for by the Veterans Health Administration “In this cross-sectional study of 5.2 million enrolled veterans, 19.6 low-value services per 100 veterans were delivered by VA facilities or VACC programs in fiscal year 2018, involving 13.6% of veterans at a cost of $205.8 million.” 

Return on Investment for Offering Employer- Sponsored Insurance[ESI] “According to Avalere’s analysis, ESI will provide an estimated 47% ROI to employers with 100 or more employees in 2022 and a 52% return in 2026. Key drivers of ROI include $275.6B from improved productivity in 2022 and $346.6B in 2026, $101B from a reduction in direct medical costs in 2022 and $108B in 2026, and $119.2B from tax benefits in 2022 and $139.7B in 2026.”

About hospitals and healthcare systems

 CMS proposal details how to become new rural hospital designation “The Biden administration released a proposed rule that grants more regulatory flexibility for small, rural hospitals in a bid to curb a worrying trend of facility closures. 
The Centers for Medicare and Medicaid Services’ proposed rule released Thursday outlines the conditions of participation for a facility to become a Rural Emergency Hospital, which enables a facility to offer emergency care, observation and other outpatient services.”

Local Supply Of Postdischarge Care Options Tied To Hospital Readmission Rates “The extent to which patients’ risk for readmission after a hospitalization is influenced by local availability of postdischarge care options is not currently known…Overall, readmission rates were negatively associated with per capita supply of primary care physicians (−0.16 percentage points per standard deviation) and licensed nursing home beds (−0.09 percentage points per standard deviation). In contrast, readmission rates were positively associated with per capita supply of nurse practitioners (0.09 percentage points per standard deviation). Our results suggest potential modifications to the Hospital Readmissions Reduction Program to account for local health system characteristics when assigning penalties to hospitals.”

About pharma

US Judge Finds for 3 Drug Distributors in WVa Opioid Lawsuit "‘The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law,’ U.S. District Judge David Faber wrote in the 184-page ruling. ‘In view of the court’s findings and conclusions, the court finds that judgment should be entered in defendants’ [AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson Corp.] favor.’”

Pharma industry spent a record $389M on US lobbying in 2021, but more is likely coming this year — report “The health sector was the biggest industry spender amongst all lobbyists, according to OpenSecrets, spending a combined $830 million between both the federal level and the states. And the pharma industry takes the trophy within the health sector over hospitals, nursing homes and health professionals after spending more than $350 million on just the federal level.”

About the public’s health

 Texas Supreme Court blocks order that allowed abortions to resume “The Texas Supreme Court in Austin granted an ‘emergency motion for temporary relief’ requested by the state’s attorney general, Republican Ken Paxton, on Wednesday that prevents a lower court order from taking effect.”

Will There Be Enough Monkeypox Vaccine? “A factory making Jynneos, the safest vaccine, has been closed since August, threatening global supplies as the virus spreads…
Jynneos, the only vaccine developed for monkeypox, is made by a small Danish company, Bavarian Nordic. The company is expected to send about two million doses to the United States by the end of the year, but can produce less than five million more for the rest of the world.”

About healthcare IT

 Google says it will delete location history for visits to abortion clinics, medical sites “Google said late Friday that it would work to quickly delete location history for people going to abortion sites and other medical sites following the Supreme Court’s overturning of Roe v. Wade last week.” 
Lest you think this risk of disclosure is hypothetical, read: Texts, web searches about abortion have been used to prosecute women

Today's News and Commentary

About Covid-19

 U.S. Supreme Court nixes religious challenge to New York vaccine mandate “The U.S. Supreme Court on Thursday declined to hear a challenge to New York's mandate that healthcare sector workers be vaccinated against COVID-19 brought by a group of doctors, nurses and others who objected on religious grounds.” 

About health insurance

 Aetna to roll back controversial prior authorization policy for cataract surgery “Under the program, Aetna required prior authorization for all cataract surgeries beginning on July 1, 2021. The policy was later modified amid outcry from ophthalmologists and other eye care experts, who urged the insurer to fully remove the requirements.
In a statement to Fierce, Aetna said that the program will be discontinued as of July 1, and that it chose to do so after gathering real-time data on cataract surgeries.”
Another instance of spending more than the resultant savings would realize.

Some medical debt is being removed from US credit reports “Starting Friday, the three major U.S. credit reporting companies will stop counting paid medical debt on the reports that banks, potential landlords and others use to judge creditworthiness. The companies also will start giving people a year to resolve delinquent medical debt that has been sent to collections before reporting it — up from six months previously.
Next year, the companies also will stop counting unpaid medical debt under at least $500.
The companies say these moves will wipe out nearly 70% of the medical debt listed on consumer credit reports.”

California first to cover health care for all immigrants “California on Thursday became the first state to guarantee free health care for all low-income immigrants living in the country illegally, a move that will provide coverage for an additional 764,000 people at an eventual cost of about $2.7 billion a year.”

Payers must post negotiated prices starting today: 8 things to know “CMS' Transparency in Coverage final rule took effect July 1, requiring payers nationwide to publish the cost of nearly every healthcare service they've negotiated with providers.”
Worth a read,

About hospitals and healthcare systems

 Fortune/Merative [Formerly IBMWatson Health]100 Top Hospitals 2022: Health Systems The top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. 

About pharma

 Novartis to eliminate up to 8000 jobs under cost-cutting plan “Novartis disclosed Tuesday that it expects to cut as many as 8000 jobs, or roughly 7% of its global workforce, including some 1400 positions in its home base of Switzerland, as it looks to knock off at least $1 billion in expenses by 2024. The company had confirmed in April that there would be layoffs as part of a broader effort to merge its pharmaceuticals and oncology businesses into a single innovative medicines unit with separate US and international commercial organisations, and to boost sales by at least 4% through 2026.”

Novartis buys FDA priority review voucher from bankrupt Mallinckrodt for $100M FYI: The latest market value for such vouchers.

About the public’s health

Kentucky Court Blocks Abortion Bans “A Kentucky state court today granted a request from the American Civil Liberties Union (ACLU), ACLU of Kentucky, and Planned Parenthood Great Northwest, Hawai‘i, Alaska, Indiana, Kentucky for a restraining order (RO). The RO blocks two laws passed in 2019 that stopped abortion services in the state last Friday: a complete abortion ban that the Kentucky Attorney General threatened to enforce following the U.S. Supreme Court’s overruling of Roe v. Wade, and a six-week ban that has been blocked by a federal court.”

This Planned Parenthood Is Now Demanding Proof of Residency for Some Abortions Planned Parenthood of Montana will no longer provide medication abortions for patients from South Dakota, Arkansas, Missouri, and Oklahoma, and will now require proof of residency for the treatment, according to an internal email obtained by The Daily Beast.
In a Thursday morning email to the state’s staff, Montana Planned Parenthood President and CEO Martha Fuller attributed the new rules for non-surgical abortions to the ‘rapidly changing’ legal landscape around the right to choose.”

HHS, AMA dismayed by Supreme Court's controversial EPA power plant ruling “The Department of Health and Human Services (HHS) and the American Medical Association (AMA) chided the 6-3 ruling on Wednesday that restricts the Environmental Protection Agency’s (EPA's) ability to regulate carbon emissions via the Clean Air Act…
Many justices agreed with coal companies and several red states that Congress didn’t give EPA the authority to devise the emission caps outlined in the Obama-era rule, which has never gone into effect.”
Another assault on the public’s health.

74 nonprofit payers launch SDOH center aimed at reducing health disparities “The Association for Community Affiliated Plans has launched a new center aimed at offering resources to payers and policymakers that will support initiatives around social determinants of health and reductions in health disparities.
The ACAP Center for Social Determinants of Health Innovation will provide policy reports, market research and roundtable educational events that will help key stakeholders address social determinants that impact an individual's health…
The new center will draw on the knowledge and resources of the association's 74 nonprofit members that collectively serve 22 million beneficiaries nationwide. Lexington, Mass.-based consulting firm Spring Street Exchange will administer the center.”

White patients’ physical responses to healthcare treatments are influenced by provider race and gender “…we found that White patients were less physiologically responsive to the expectations set by Black as compared to Asian providers. For a variety of reasons, a Black provider may be less consistent with the image of a doctor than an Asian provider. What we did not anticipate, however, is that White patients would respond to the expectations set by the Asian providers in the same manner as the expectations set by the White providers. White patients responded to White and Asian providers similarly…”

About healthcare finance

 Blueprint rounds up $1.25B to grow cancer portfolio through internal R&D and dealmaking “The Massachusetts biotech is selling certain royalties to its targeted cancer drugs Ayvakit and Roche-partnered Gavreto and securing additional money for future business development in separate deals with Sixth Street and Royalty Pharma. The two agreements give Blueprint $575 million immediately in cash, and the total financing could reach $1.25 billion.
The transactions allow Blueprint to benefit now from its marketed meds and pipeline prospects, particularly when it comes to Ayvakit’s potential expansion into non-advanced systemic mastocytosis…”

Today's News and Commentary

About Covid-19

 Government nearly exhausts monoclonal COVID treatment funding with new purchase “Eli Lilly has announced the U.S. government is buying an additional 150,000 courses of the only monoclonal antibody therapy left that still holds up against all COVID-19 variants of concern, including BA.2.
The new purchase of the therapy, called bebtelovimab, is costing the government roughly $275 million…
This new purchase was paid for out of the $10 billion in COVID funding, which the White House diverted earlier this month to pay for more vaccines and treatments.
Officials said at the time they were left with ‘no choice’ but to shift those dollars, since Congress has not yet approved additional funding.”

Omicron-based coronavirus booster shots will roll out this fall “This fall, vaccine makers will begin rolling out coronavirus booster vaccines better tailored to fight the current phase of the pandemic.
Two days after outside experts voted in favor of a new vaccine adapted to protect against omicron, the Food and Drug Administration announced that the fall shots would include a component from BA.4 and BA.5, the omicron subvariants gaining ground in the United States.”

About health insurance

 Hospitals have to post their prices. Now, health insurers and employers have to publish what they pay “The federal government’s latest push for more health care price transparency starts July 1, and it is focused on those who are writing the checks: Health insurance companies and employers that directly pay for their workers’ medical care will have to start posting data on what they pay hospitals, doctors, and other providers.”

Medicaid:State Directed Payments in Managed Care From the GAO: “As of February 2022, Medicaid approved 79 proposals just for payments starting on or after July 1, 2021—totaling $20 billion in estimated payments.
Medicaid is trying to improve oversight, but there are still unknowns. For example, states only have to report estimated payments, so Medicaid won't know how much of that $20 billion is paid out.”
The GAO recommends that states report actual payment amounts.

Brookings: Zero-dollar premiums could improve coverage on ACA exchanges compared to those paying small amount “Completely eliminating premiums for low-income Affordable Care Act exchange customers that pay a very small amount a month could boost coverage by 48,000 this year, a new analysis finds.”
However, no mention is made of the zero premium’s effect on out of pocket expenses, which, in many cases, is the real affordability issue.

About hospitals and healthcare systems

 Senators quietly kill plan to overhaul VA healthcare system “A bipartisan group of 12 senators is rejecting the Department of Veterans Affairs' plan to close or overhaul hospitals that no longer meet the healthcare needs of U.S. veterans, according to a June 29 report by The Washington Post.
The senators, led by Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said they would not approve the nine nominees up for confirmation to establish the Asset and Infrastructure Review Commission.”
for obvious political reasons, members of Congress are always reluctant to vote to shut down underused facilities in their districts- no matter the monetary cost.

Updated Guidance for Nursing Home Resident Health and Safety From CMS, FYI.

About pharma

 Democrats forge ahead on drug pricing, eyeing wider deal with Manchin “Democratic leaders have finalized a revised proposal to lower prescription drug prices for seniors, part of a broader scramble to satisfy Sen. Joe Manchin (D-W.Va.) and resurrect a long-stalled economic package that they hope to advance as soon as this summer…
Under the proposal, the drug negotiations are set to begin in 2023, according to details obtained by The Washington Post. Democrats also have preserved plans to cap seniors’ drug costs under Medicare at $2,000 each year, while penalizing companies that raise prescription prices faster than inflation.”

Sanofi caps out-of-pocket insulin cost at $35 for uninsured U.S. patients “French drugmaker Sanofi said on Wednesday uninsured diabetes patients in the United States will pay no more than $35 for 30-day supply of insulin, in the wake of heightened public scrutiny over soaring prices of the life-saving drug.
Sanofi said the new price, down from the prior out-of-pocket cost of $99, will be effective from July 1.”

About the public’s health

 Judge says Florida's 15-week abortion law is unconstitutional “In a setback for Florida Gov. Ron DeSantis and Republican lawmakers, a Florida judge has ruled that a new state law banning abortions at 15 weeks is unconstitutional and he intends to block it from taking effect on Friday.
In a verbal ruling on Thursday, Second Judicial Circuit Court Judge John Cooper said he would be issuing a temporary statewide injunction that will go into effect once he signs the written order in the challenge brought by some Florida abortion providers…
In his ruling from the bench, Cooper said the ban ‘violates the privacy provision of the Florida Constitution.’”

Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association From the American Heart Association: “The components of Life’s Essential 8 include diet (updated), physical activity, nicotine exposure (updated), sleep health (new), body mass index, blood lipids (updated), blood glucose (updated), and blood pressure. Each metric has a new scoring algorithm ranging from 0 to 100 points, allowing generation of a new composite cardiovascular health score (the unweighted average of all components) that also varies from 0 to 100 points. Methods for implementing cardiovascular health assessment and longitudinal monitoring are discussed, as are potential data sources and tools to promote widespread adoption in policy, public health, clinical, institutional, and community settings.”

About healthcare IT

HHS Issues Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe “Specifically, the guidance:

  • Reminds HIPAA covered entities and business associates that they can use and disclose PHI, without an individual’s signed authorization, only as expressly permitted or required by the Privacy Rule.

  • Explains the Privacy Rule’s restrictions on disclosures of PHI when required by law, for law enforcement purposes, and to avert a serious threat to health or safety…

  • Explains how to turn off the location services on Apple and Android devices.

  • Identifies best practices for selecting apps, browsers, and search engines that are recognized as supporting increased privacy and security.

In a related article: You scheduled an abortion. Planned Parenthood’s website could tell Facebook.”An investigation by Lockdown Privacy, the maker of an app that blocks online tracking, found that Planned Parenthood’s web scheduler can share information with a variety of third parties, including Google, Facebook, TikTok and Hotjar, a tracking tool that says it helps companies understand how customers behave. These outside companies receive data including IP addresses, approximate Zip codes and service selections, which privacy experts worry could be valuable to state governments looking to prosecute abortions…
Planned Parenthood spokeswoman Lauren Kokum said the organization uses trackers for its marketing efforts…
Facebook, Google and TikTok declined to comment on how precisely they would respond to governments’ requests for data surrounding abortion. Hotjar did not respond to a request for comment.”

 Providers, payers need to move beyond compliance with FHIR interoperability, experts say. Here's why “By year-end 2022, most electronic health record (EHR) systems are required to update their software to support the Bulk FHIR API standard, which allows data to flow in batches at a population level.
 But, experts caution, steps need to be taken to ensure the standard is not solely treated as a compliance requirement. To have a positive effect on outcomes, organizations should go further, committing to not only share health data but also contextualize them to drive better health outcomes.”

EHR Vendor athenahealth Launches Voice-Driven Tech to Cut Clinician Burnout “EHR vendor athenahealth has announced the release of athenaOne Voice Assistant Powered by Nuance, a voice-driven application that aims to alleviate clinician burnout and enhance the patient experience.
Voice Assistant is a natural command-based virtual assistant developed and built by athenahealth and powered by Nuance's Dragon Medical technology. Using the technology, providers can document exams, create draft orders, retrieve clinical data, and review their schedules.”
I wonder why it took so long for an EHR to integrate voice technology.

About healthcare finance

 ARCH Venture Partners to invest nearly $3 billion in early-stage biotech firms “ARCH Venture Partners announced Wednesday that it raised nearly $3 billion to invest in early-stage biotechnology companies via its new ARCH Venture Fund XII. Early last year, the firm closed its ARCH Venture Fund XI with around $1.9 billion to support the creation and funding of biotech start-ups.
’Science doesn't care what markets are doing, and science moves forward,’ remarked Robert Nelsen, ARCH co-founder, adding ‘all the fundamental innovations in biotechnology are accelerating, with huge promise for new preventive, disease-modifying, and even curative treatments.’”

Today's News and Commentary

About Covid-19

 Paxlovid Cuts Odds for Hospitalization After Omicron Infection by 45% “The protection was lower than the 90% reduction in hospitalization found in Paxlovid's clinical trials, which took place during the Delta wave of COVID, said lead researcher Dr. Scott Dryden-Peterson, an infectious disease specialist with Brigham and Women's Hospital in Boston.
But even when facing the more infectious Omicron variant, Paxlovid still matches the effectiveness found when using Tamiflu to prevent influenza hospitalizations, Dryden-Peterson said.”

About health insurance

Which states see most of their wages spent on health insurance? And how does this compare to other costs of living factors? At the top is West Virginia- 20.85% of wages spent on health insurance. The actual cost was also the highest among the top 10. The article is worth a quick read.

Frequently Asked Questions (FAQs) about Consolidated Appropriations Act, 2021 Implementation This document, just published by CMS, explains “Requirements Related to Surprise Billing; Part I” and “Requirements Related to Surprise Billing; Part II,”

About pharma

Walgreens stock falls after decision to keep Boots, No7 Beauty businesses after lack of adequate buyout interest “Shares of Walgreens Boots Alliance Inc. fell 1.7% ion premarket trading Tuesday, after the drugstore chain said it decided to keep its U.K.-based health and beauty retailer Boots and No7 Beauty Company businesses... Walgreens said that while the decision followed discussions with a range of prospective buyers expressing ‘significant interest’ in the businesses, the financial markets suffered ‘unexpected and dramatic change’ since the review process began. ‘As a result of market instability severely impacting financing availability, no third party has been able to make an offer that adequately reflects the high potential value of Boots and No7 Beauty Company,’ Walgreens stated.”

Oklahoma Settles With Three Opioid Distributors at Over $250 Million The latest in the ongoing litigation saga: “Opioid distributors McKesson, Cardinal and AmerisourceBergen have agreed to pay a $250 million settlement to the state of Oklahoma over their alleged roles in the opioid epidemic.” 

About the public’s health

Tens of thousands of monkeypox vaccines rushed to clinics A good update on his disease.

About health technology

Judge rules Apple Watch infringed AliveCor's ECG patent, setting up potential U.S. import ban “An administrative judge at the International Trade Commission (ITC) sided with AliveCor in its case against Apple, ruling that the tech giant has infringed the company's patented electrocardiogram technology.
If affirmed by the full ITC, the administrative law judge's finding of a violation could lead to the issuance of a limited exclusion order barring the import of infringing Apple Watches.
The commission is expected to issue a final decision by Oct. 26.” 

Today's News and Commentary

About Covid-19

F.D.A. advisers recommend updated boosters that target forms of Omicron. “An expert committee recommended Tuesday that the Food and Drug Administration plan on an updated booster shot of the coronavirus vaccines that targets some form of the Omicron variant that has dominated for months.
The panel’s vote paves the way for F.D.A. regulators to push for a new formulation for shots that the Biden administration hopes to offer later this year, before an expected winter resurgence of the virus.
The committee debated but did not specify which formulation might work best. The F.D.A. appeared to be leaning strongly toward a combination of the existing vaccine and two subvariants of Omicron, known as BA.4 and BA.5.”
If you are interested in the process that went into the decision, see: https://www.youtube.com/watch?v=BFdzNUus_CE

Pfizer CEO to Israeli TV: Omicron shots ready for use as soon as FDA approves “Revamped vaccines that protect against COVID-19 variants are ready to be shipped as soon as they are approved by US health authorities, Pfizer CEO Albert Bourla said on Israeli television on Sunday, as he visited Israel to receive the prestigious Genesis Prize.
The company’s original vaccine, the first shot to be made available against COVID-19, has been updated to fight the now-dominant Omicron variant and is set to be discussed by the US Food and Drug Administration (FDA) on Tuesday.”

 Vaccine mandate for federal workers won’t go into effect until at least fall “The Biden administration’s coronavirus vaccination mandate for federal workers will not take effect at least until the fall.
The U.S. Court of Appeals for the 5th Circuit said Monday that it would reconsider a ruling by a three-judge panel that would have allowed the mandate to go into effect. The court, meanwhile, scheduled oral arguments for the week of Sept. 12.”

US government to invest up to $75mn in new Croda factory “The US government is investing up to $75mn in London-listed Croda’s new factory to shore up domestic production of a crucial component of mRNA vaccines, after the company provided the lipid nanoparticles for the BioNTech/Pfizer Covid-19 shot. 
Croda, a speciality chemical manufacturer, is also investing up to $58mn in the new site in Pennsylvania as it seeks to expand its US manufacturing capacity. 
The US Biomedical Advanced Research and Development Authority, which is charged with preparing the country for health crises, and an arm of the US department of defence are teaming up to invest in the site, which will support initiatives to prepare for any future pandemic.”

About health insurance

Anthem is now Elevance Health “The company formerly known as Anthem commemorated its official rebranding to Elevance Health on June 28 by ringing the opening bell at the New York Stock Exchange and beginning to trade under the new ticker symbol ‘ELV.’
The former Anthem website now reflects the name change, which is a combination of the words elevate and advance to represent the company's commitment to ‘elevating the importance of whole health and advancing health beyond healthcare for consumers.’"

 Supreme Court won't take up lawsuit over PBM liability under ERISA  “The Supreme Court declined to take up a lawsuit debating whether a pharmacy benefit manager has a fiduciary duty to lower drug prices, handing the industry a major win.
The court announced Monday it will not take up the class-action lawsuit John Doe vs. Express Scripts. The decision comes amid increased scrutiny from the federal government and Congress on the PBM industry’s role in the drug supply chain.
The lawsuit focuses on whether a PBM has a fiduciary duty under the Employee Retirement Income Security Act (ERISA) to lower drug prices if it has the ability to do so.”

Biden admin puts insurers on notice for compliance with ACA contraceptive mandate “Department of Health and Human Services (HHS) Secretary Xavier Becerra, Department of Labor Secretary Marty Walsh and Department of the Treasury Secretary Janet Yellen issued a joint letter to plan sponsors "reminding" them of their obligations.
The ACA mandates coverage for preventive women's health services, including contraceptive counseling and free birth control, for individuals and dependents. However, the secretaries say "recent reports" suggest insurers may not be holding up their end of the bargain.”

Two Individuals Convicted in $1.4 Billion Health Care Fraud Scheme Involving Rural Hospitals in Florida, Georgia, and Missouri “According to court documents and evidence presented at trial, Jorge Perez, 62, and Ricardo Perez, 59, both of Miami, Florida, conspired with each other and others to unlawfully bill for approximately $1.4 billion of laboratory testing services which were medically unnecessary, and that fraudulently used rural hospitals as billing shells to submit claims for services that mostly were performed at outside laboratories. Jorge Perez and Ricardo Perez also committed health care fraud on five specific occasions, and conspired to launder the proceeds of this fraudulent scheme…
The evidence showed that the defendants targeted and obtained control of financially distressed rural hospitals through management agreements and purchases. The defendants sought to obtain control of these rural hospitals because of private insurance contracts that provided for higher reimbursement rates for laboratory testing — a common feature of rural hospital contracts designed to ensure that the hospitals can survive and provide rural communities with much needed care. The defendants promised to save these rural hospitals from closure by turning them into laboratory testing sites, but instead billed for fraudulent laboratory testing worth hundreds of millions of dollars in a sophisticated and years-long ‘pass-though’ billing scheme. The scheme made it appear that the rural hospitals themselves did the laboratory testing when, in most cases, it was done by testing laboratories controlled by certain defendants.”

Biden Administration Announces New Model to Improve Cancer Care for Medicare Patients “Building on the lessons learned from the Innovation Center’s Oncology Care Model (tested from July 1, 2016 – June 30, 2022), EOM [Enhancing Oncology Model] is a voluntary model that will run for five years, from July 2023 through June 2028. Model participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer…
In addition to requiring participants to screen for health-related social needs, EOM includes other design elements that help drive CMS’ commitment to advancing health equity, including:

  • Offering an additional payment to participating oncology practices that provide Enhanced Services to patients who qualify for both Medicare and Medicaid,

  • Requiring participating providers to report patient demographic data (e.g., race, ethnicity, language, gender identity), and

  • Requiring participating providers to develop plans showing how they will address health equity gaps in their patient population.

    A fact sheet on EOM is available at: https://www.cms.gov/newsroom/fact-sheets/enhancing-oncology-model

About hospitals and healthcare systems

 AMERICA’S MOST SOCIALLY RESPONSIBLE HOSPITALS FYI: From the Lown Institute.

 National Hospital Flash Report: June 2022 “Takeaways at a Glance:

1.Nearly halfway through 2022, margins are cumulatively negative.

2. While some metrics have normalized, hospitals continue to perform below pre-pandemic levels, and there is an uncertain outlook for the rest of the year.

3.Elevated labor costs remain a significant challenge. Hospitals are still seeing higher labor costs and fewer hours worked, a sign of inflation and an indicator that long-standing labor shortages are likely worsened by increased turnover.

4.Warmer temperatures and ED visits drove up volumes and revenues. Patients often schedule elective procedures during the summer months, which may have contributed to growing volumes. Emergency department visits also spiked this past month as people spent more time outdoors.

5.Pent-up demand for hospital services also contributed to an increase in patients. Sicker patients continued to schedule procedures they had previously postponed, suggesting a return to normalcy as COVID-19 hospitalizations remained relatively low.

About the public’s health

 The Supreme Court's abortion ruling shifts legal battles to state courts “Judges temporarily blocked abortion bans Monday in Louisiana and Utah, while a federal court in South Carolina said a law restricting the procedure after six weeks of pregnancy would take effect there immediately as the battle over the fall of Roe v. Wade shifted from the nation's highest court to courthouses around the country.”

Federal Workers Get Sick Leave for Health Travel With Roe Voided “Federal Workers Get Sick Leave for Health Travel With Roe Voided. Federal employees can use sick leave to travel for medical care, the Office of Personnel Management said Monday, days after the Supreme Court overturned Roe v. Wade and allowed states to ban abortion.”

About healthcare IT

HIPAA won’t protect you if prosecutors want your reproductive health records With Roe v. Wade now overturned, patients are wondering whether federal laws will shield their reproductive health data from state law enforcement, or legal action more broadly. The answer, currently, is no.
If there’s a warrant, court order, or subpoena for the release of those medical records, then a clinic is required to hand them over. And patients and providers may be made legally vulnerable by the enormous trail of health-related data we all generate through their devices every day.
As far as health records go, the most salient law is HIPAA — the Health Insurance Portability and Accountability Act. It’s possible that federal officials could try to tweak it, so records of reproductive care or abortion receive extra protection, but legal experts say that’s unlikely to stand up in the courts in a time when many judges tend to be unfriendly to executive action.”

 Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis “Several studies have highlighted the need for greater clinical validation and found that many solutions were not supported by robust clinical evidence and demonstrated mixed results on cost savings and cost-effectiveness. In addition, there is evidence that some claims made by digital health companies have been misleading…”
”A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r2=0.02), clinical robustness and total funding (r2=0.08), or clinical robustness and company age (r2=0.18).”

About health technology

 CRISPR debuted 10 years ago, in a paper hardly anyone noticed. Jennifer Doudna reflects on the DNA scissors’ first decade FYI

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW  “As of June 22, 2022, the current 7-day moving average of daily new cases (97,430) decreased 5.6% compared with the previous 7-day moving average (103,175). A total of 86,512,787 COVID-19 cases have been reported in the United States as of June 22, 2022.”
Check the site for stats in your county.

Pfizer, BioNTech's Omicron-adapted COVID-19 candidate vaccines show promise “Pfizer and BioNTech announced that booster doses of two different Omicron-adapted COVID-19 vaccine candidates elicited a substantially higher immune response against Omicron BA.1 than the companies' current mRNA-based shot Comirnaty. Pfizer CEO Albert Bourla said ‘based on these data, we believe we have two very strong Omicron-adapted candidates.’
The vaccine candidates tested in the Phase II/III trial include an Omicron-adapted monovalent immunisation and a bivalent shot, which combines Comirnaty with a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern.” 

About pharma

U.S. Supreme Court sides with doctors challenging opioid convictions “The justices ruled 9-0 in favor of Xiulu Ruan and Shakeel Kahn, who had argued in appealing their convictions that their trials were unfair because jurors were not required to consider whether the two physicians had "good faith" reasons to believe their numerous opioid prescriptions were medically valid.
Liberal Justice Stephen Breyer, writing for the court, said that once defendants produce evidence that they were authorized to dispense controlled substances like opioids, prosecutors must prove they knew they were acting in an unauthorized manner.
The justices sent the two cases back to federal appeals courts that had previously upheld their convictions for further proceedings, where prosecutors may argue that any mistakes in their jury instructions amounted to harmless errors.”

Walgreens settles for $105M in generic drug case “Walgreens agreed to shell out $105 million in cash to its shareholders June 23 after a seven-year class-action lawsuit about the spike in generic drug prices and reimbursement rates, according to court documents. 
In the initial complaint on April 10, 2015, investors accused Walgreens of concealing the impact of higher drug costs on its pharmacy business before the company's stock price fell.”

 Bristol Myers loses bid to toss $6.4B CVR lawsuit tied to Celgene takeover, Breyanzi approval “A U.S. federal court on Friday shot down Bristol Myers Squibb’s motion to dismiss an investor lawsuit connected to its $74 billion Celgene buyout.
Filed by former Celgene shareholders last June, the suit hinges on a $6.4 billion Contingent Value Rights (CVR) agreement that evaporated when one of three drugs at the center of the megadeal—the CAR-T non-Hodgkin lymphoma treatment Breyanzi—failed to snag FDA approval by a Dec. 31, 2020, deadline.
BMS has sought to dismiss the case, which accuses the drugmaker of “blatant misconduct" for failing to apply ‘diligent efforts’ to secure a timely approval for Breyanzi.”

About the public’s health

Three excellent articles in the wake of the SCOTUS’ “Roe” decision on Friday:
Seeking an abortion? Here’s how to avoid leaving a digital trail.

What a post-Roe America looks like A great review of the national landscape

No, Justice Alito, Reproductive Justice Is in the Constitution An op-ed piece in The New York Times views the issue from a racial justice standpoint.

Federal court blocks FDA ban on Juul e-cigarette sales in U.S. “A federal court on Friday granted a request by Juul Labs to temporarily block an order by the Food and Drug Administration to stop selling its electronic cigarettes in the U.S.
The e-cigarette maker had asked the U.S. Court of Appeals for the D.C. Circuit to stay what it calls an ‘extraordinary and unlawful action’ by the FDA that would require it to immediately halt its business. The company, which is partly owned by tobacco giant Altria, filed an emergency motion with the appeals court as it prepares to appeal the FDA's decision. “

 Biden signs gun-control legislation into law As expected, on Saturday the President signed this bipartisan legislation.

Life Expectancy for White, Black, and Hispanic Race/Ethnicity in U.S. States: Trends and Disparities, 1990 to 2019 “Disparities in LE [life expectancy] across states were 8.0 years for females and 12.2 years for males in 1990 and 7.9 years for females and 7.8 years for males in 2019. When race/ethnicity groups were accounted for, disparities across states were 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019. Disparities across states increased within each race/ethnicity group between 1990 and 2019, with the largest increase for non-Hispanic White males and the smallest for Hispanic females. The disparity between race/ethnicity groups within states decreased for most of the 23 states with estimates for all 3 groups but increased for females in 7 states and males in 5 states.”

About healthcare IT

Trends in telehealth use by Medicare fee-for-service beneficiaries and its impact on overall volume of healthcare services “From April 2020 through December 2021, the monthly volume of telehealth services slowly declined and has plateaued between 8.5-9.5% of all outpatient E&M services received by Medicare fee-for-service beneficiaries. Importantly, the total volume of outpatient E&M services was lower in 2020 and 2021, suggesting that the COVID-19 telehealth flexibilities have not increased the overall volume of outpatient E&M services received by Medicare beneficiaries. These findings should mitigate some concerns about the impact of telehealth on overall healthcare utilization.”
This research (preprint) confirms that telemedicine is a replacement, not extension, for in-person care.

Today's News and Commentary

Supreme Court overturns Roe v. Wade 6-3, ending constitutional protections for abortion “The Supreme Court ruled 6-3 Friday morning to remove constitutional protections for abortion in a much-anticipated opinion overruling landmark abortion cases Roe v. Wade and Planned Parenthood v. Casey.
‘The Constitution does not confer a right to abortion; Roe and Casey must be overruled, and the authority to regulate abortion must be returned to the people and their elected representatives,’ Justice Samuel Alito wrote in the majority opinion for Dobbs v. Jackson Women’s Health Organization.”
Most responses to this ruling are predictable and non-actionable. The following one, however, is noteworthy: Merrick Garland, U.S. Attorney General

“‘The Justice Department strongly disagrees with the Court’s decision. ... We stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care. In particular, the FDA has approved the use of the medication Mifepristone. States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy. 
Furthermore, federal agencies may continue to provide reproductive health services to the extent authorized by federal law. And federal employees who carry out their duties by providing such services must be allowed to do so free from the threat of liability. ... The Justice Department will use every tool at our disposal to protect reproductive freedom.’”

Congress passes most significant gun reform bill in decades, sends it to Biden Following Senate passage late Thursday, the House passed the bipartisan bill that takes steps to restrict gun access for the youngest buyers, domestic violence offenders and others who could pose a risk to their communities. The Bipartisan Safer Communities Act also would fund school safety and mental health programs.
The House approved it by a 234-193 margin, as 14 Republicans joined all Democrats. The legislation heads to President Joe Biden, who is expected to quickly sign it into law.”

About Covid-19

 Advisers to the C.D.C. recommend Moderna’s vaccine for children and teens aged 6 through 17. “Advisers to the Centers for Disease Control and Prevention on Thursday voted unanimously to recommend Moderna’s coronavirus vaccine for children and adolescents aged 6 through 17 years.
Their endorsement was neither a surprise, nor urgently anticipated. The Food and Drug Administration authorized the Moderna vaccine for that age group late last week, and the decisions of the two agencies have rarely been at odds.”

About health insurance

 CMS approves first-ever public option plan for Colorado's ACA exchange “Colorado can now create its own state-specific public option Affordable Care Act plan starting next year after getting key approval from the Biden administration. 
The Department of Health and Human Services (HHS) granted a Section 1332 state innovation waiver to create the state-specific health plan. It is the first state to get approval for a public option plan…
The plan will be sold on the ACA’s exchanges and is expected to lower premiums by an average of 22%, or approximately $132 per person a month.
Colorado’s plan must cover all essential health benefits required by the ACA and establish premium reduction targets. Any county that has an ACA insurer offering a plan on the individual or small group market must also offer the Colorado Option plan.” 

About hospitals and healthcare systems

 Supreme Court backs HHS approach to Medicare payments for hospitals serving low-income patients “The Supreme Court on Friday upheld the approach taken by the Department of Health and Human Services in calculating certain Medicare payments for hospitals that serve a large number of low-income patients.
The legal challenge targeted HHS’ interpretation of the formula used to calculate Medicare’s disproportionate share hospital adjustments, known as DSH payments.
The high court said that the agency did not misinterpret the law with a policy it rolled out in the mid-2000s that dictated the payments hospitals received for treating a disproportionate share of low-income patients.
‘Today, we approve HHS’s understanding of the Medicare fraction,’ Justice Elena Kagan wrote for the 5-4 majority, adding that ‘HHS’s regulation correctly construes the statutory language at issue.’”

About pharma

FDA Stopped Record Number of Drug Shortages Last Year “The FDA claims it prevented a total of 317 drug shortages in 2021 — marking the highest number of potential shortages avoided since the agency began reporting them to Congress in 2012.”

About healthcare finance

 Pharmaceutical & life sciences: Deals 2022 midyear outlook From PWC: “Increased scrutiny from the US Federal Trade Commission (FTC) around larger deals could mean that 2022 will be a year of bolt-on transactions in the $5 to $15 billion range as pharma companies take multiple shots on goal in order to make up for revenues lost to generic competition in the remainder of the decade…
Expect to see big pharma picking up earlier stage companies to try and fill the pipeline gaps that are likely to start in 2024. While market conditions suggest bargain prices for biotech are possible, recent transactions indicate that pharma companies are still paying significantly above current trading prices (ranging from approximately 50 to 100% of current trading), but below the peak valuations of recent memory.
In the first few months of the year, semi-annualized deal value was down 58% from the same period last year, with companies investing just $61.7 billion so far. Only 137 deals were announced during that time, compared to 204 in the year-prior period.”

Today's News and Commentary

About Covid-19

New coronavirus subvariants escape antibodies from vaccination and prior Omicron infection, studies suggest “Omicron subvariants BA.4 and BA.5 appear to escape antibody responses among both people who had previous Covid-19 infection and those who have been fully vaccinated and boosted, according to new data from researchers at Beth Israel Deaconess Medical Center, of Harvard Medical School.
However, Covid-19 vaccination is still expected to provide substantial protection against severe disease, and vaccine makers are working on updated shots that might elicit a stronger immune response against the variants.”

U.S. delivers 2.7 mln COVID vaccine doses for kids under five to administration sites “The United States has delivered about 2.7 million doses of COVID vaccines for children below five years to administration centres while another one million shots will reach the sites soon, the Department of Health and Human Services said on Wednesday.”

Moderna bivalent COVID-19 booster shows promise against Omicron subvariantsModerna announced Wednesday that its Omicron-targeting coronavirus booster shot significantly increased antibodies against the strain's newest subvariants, though the immune response was less potent than seen with the Omicron ‘parent’ strain that emerged late last year. According to Moderna, its mRNA-1273.214 candidate exhibited a ≥5-fold boost in neutralising antibodies against the BA.4 and BA.5 subvariants in a Phase II/III study.”

About hospitals and healthcare systems

HCA, McKesson to form oncology research joint venture “The joint venture between McKesson's U.S. Oncology Research and HCA Healthcare's Sarah Cannon Research Institute plans to offer an expanded clinical research network, a broader portfolio of clinical trials, and enhanced data and analytics capabilities to better match patients to trials.
The transaction is expected to close in 2022. McKesson will own 51 percent of the joint venture and have operating control.”

About pharma

 Industry sponsorship bias in cost effectiveness analysis [CEA]: registry based analysis “Among 5877 CEAs that reported positive incremental costs and quality adjusted life years, ICERs [incremental cost effectiveness ratios] from industry sponsored studies were 33% lower (95% confidence interval −40 to −26) than those from non-industry sponsored studies.”
Comment: This article was quoted by many news outlets, but the need for independent studies is not new. See, for example, Industry sponsorship and research outcome from 2017.

Novartis, GSK commit $1.25B to R&D spending plan for tropical diseases and beyond “Novartis and GSK have both pledged serious amounts of money towards R&D for neglected tropical diseases. Swiss pharma Novartis announced its commitment of $250 million, which covers a five-year period, will support work on malaria, Chagas disease, leishmaniasis, dengue fever and cryptosporidiosis.
Meanwhile, GSK promised $1 billion over a decade to accelerate R&D dedicated to infectious diseases that disproportionately impact lower-income countries. The research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV—through GSK's ViiV unit—neglected tropical diseases and anti-microbial resistance.”

About the public’s health

 Human Papillomavirus Vaccination Trends Among Adolescents: 2015 to 2020 “Overall, HPV vaccination coverage (≥1 dose) among adolescents significantly increased from 56.1% in 2015 to 75.4% in 2020.” 

CDC touts vaccine for gay men for Florida meningitis surge “Health officials on Wednesday recommended that men in Florida who have sex with other men get a meningococcal vaccine following one of the worst outbreaks among gay and bisexual men in U.S. history of a bacteria that causes meningitis.
The Centers for Disease Control and Prevention said in a statement that there have been at least 24 cases and seven deaths among gay and bisexual men caused by the bacteria in Florida recently.”

FDA orders Juul e-cigarettes off the market, citing insufficient and conflicting data “Juul, the once-booming Silicon Valley start-up widely blamed for igniting the youth vaping epidemic, was grounded Thursday by federal regulators who ordered its e-cigarette products off the market, a move so sweeping that it surprised even some anti-tobacco advocates.
The Food and Drug Administration denied Juul’s applications to continue selling e-cigarette devices and pre-filled cartridges in menthol and tobacco flavors. It was the most dramatic action in the agency’s years of effort to crack down on youth vaping.”

FDA approves 15-valent pneumococcal vaccine for children “Merck announced Wednesday that the FDA approved an expanded indication for Vaxneuvance, the company’s 15-valent pneumococcal conjugate vaccine, to include its use in infants and children aged 6 weeks to 17 years.
The vaccine, formerly known as V114, was approved by the FDA last July for adults.”

U.S. to expand monkeypox testing at commercial labs as outbreak grows “The Biden administration announced Wednesday it is authorizing commercial laboratories to conduct monkeypox tests in an attempt to dramatically expand testing as the United States confronts a record outbreak that experts fear is far larger than the official count of 156 cases.
The Centers for Disease Control and Prevention started shipping test kits to five commercial laboratory companies this week, allowing health providers to order tests from the labs directly by early July. The companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories and Aegis Sciences.”

US health care can’t afford health inequitiesInequities in the US health system cost approximately $320 billion today and could eclipse $1 trillion in annual spending by 2040 if left unaddressed…
Deloitte’s model looked at several high-cost diseases such as breast cancer, diabetes, colorectal cancer, asthma, and cardiovascular disease. For these diseases, our actuaries determined the proportion of spending that could be attributed to health inequities. For instance, Black adults are 60% more likely than white adults to be diagnosed with diabetes and two to three times more likely to have complications, according to research. Racial inequity often contributes to a late diagnosis and comorbidities. Our analysis determined that 4.8% of spending on diabetes is associated with health care disparities, which results in $15 billion in unnecessary spending. Similarly, health care spending on asthma is about $56 billion a year.About 4.3% of those costs are related to income disparities, which can result in late diagnoses and challenges in accessing appropriate care and medications.” 

Today's News and Commentary

About Covid-19

 WHO-Backed Advisory Group Supports Omicron COVID-19 Booster “A World Health Organization (WHO) advisory panel has recommended an Omicron-adapted COVID-19 booster dose for those who have already received primary COVID-19 vaccine doses…
The group also advised that an Omicron-specific monovalent vaccine for a primary series is not recommended due to insufficient information regarding its efficacy against other variants of concern.”

About health insurance

MEDICARE AND BENEFICIARIES PAIDSUBSTANTIALLY MORE TO PROVIDER- BASED FACILITIES IN EIGHT SELECTED STATES IN CALENDAR YEARS 2010 THROUGH 2017 THAN THEY PAID TO FREESTANDING FACILITIES IN THE SAME STATES FOR THE SAME TYPE OF SERVICES From the HHS OIG. The headline is the message. The recommendation is: “… that CMS pursue legislative or regulatory changes to lower costs for both the Medicare program and beneficiaries, by equalizing payments as appropriate between provider- based facilities and freestanding facilities for E&M services.”

 UnitedHealth Rejected by High Court on Medicare Overpayments “The US Supreme Court rejected an appeal by UnitedHealth Group Inc., leaving in place a federal rule designed to allow the government to recoup billions of dollars in overpayments from insurers that participate in the Medicare Advantage program.UnitedHealth and its allies argued unsuccessfully that the 2014 Centers for Medicare & Medicaid Services rule will gut the popular program, forcing insurers to reduce coverage and benefits or raise premiums for many of the 26 million seniors who are enrolled.”

Molina settles claims of MassHealth fraud, improper licensure of healthcare staff for $4.6M “The Justice Department said Molina Healthcare and former subsidiary Pathways of Massachusetts have agreed to pay a settlement of $4.625 million over allegations of False Claims Act violations and improper licensure and supervision of healthcare employees.
Between November 2015 and March 2018, Molina owned and operated Pathways, a group of mental health centers, in Springfield and Worcester, Mass. Federal and state officials allege that the two entities improperly submitted reimbursement claims to the state's Medicaid program, MassHealth, and associated organizations…
Additionally, the government claims that the payer failed to properly license and supervise Pathways employees, including social workers and psychological associates…”

Optum launches new solution aimed at driving down unnecessary testing “The laboratory benefit management tool will assist insurers in aligning lab tests with clinical guidance and will automate large parts of lab benefit administration, Optum said in an announcement provided first to Fierce Healthcare.
The company estimates that insurers could save between $12 to $36 per member per year, or about $3 billion.”

About hospitals and healthcare systems

 The unintended consequences of the $178 billion bailout to keep hospitals and doctors afloat “…data show that the money indeed served as a lifeline for many hospitals that might not have withstood the onslaught of the coronavirus — but the funds also exacerbated the gap between the industry’s haves and have-nots, disproportionately rewarding wealthy hospitals that did not need the money as urgently. Many institutions reported strong profits and pursued growth strategies without pause.” 

About pharma

 Estimates of Probabilities of Successful Development of Pain Medications: An Analysis of Pharmaceutical Clinical Development Programs from 2000 to 2020 “The overall probability of successful development of all pain medications from phase 1 to approval is 10.4% (standard error, 1.5%). Medications to treat nociceptive and neuropathic pain have a probability of successful development of 13.3% (standard error, 2.3%) and 7.1% (standard error, 1.9%), respectively. The probability of successful development of medications with high abuse potential and low abuse potential are 27.8% (standard error, 4.6%) and 4.7% (standard error, 1.2%), respectively.” 

Express Scripts’ ‘refill pill mill’ bilked government, suit alleges “Express Scripts delivered unnecessary prescription drugs to military personnel, bilking the federal government and vendors out of billions of dollars, a whistleblower alleges in a False Claims Act lawsuit. 
The St. Louis-based pharmacy benefit manager allegedly enrolled as many Tricare beneficiaries as possible in automatic delivery, which was set up to provide an extra nine-month supply of drugs over the course of a year, according to a qui tam lawsuit filed in a California federal court in mid-2019 and unsealed Friday. Express Scripts inflated drug costs for payers and patients through its ‘refill pill mill’ that systematically overcharged the military’s health insurance program for unnecessary medication from October 2009 to March 2018, the suit alleges.”

Purdue Pharma launches no-profit treatment to reverse opioid overdose effects “Five months after the FDA approved Purdue Pharma's opioid antagonist injection, nalmefene hydrochloride, the no-profit treatment is now available for use, according to a June 21 press release.”

Novartis plots Precision attack on sickle cell, paying $75M and putting up $1.4B in biobucks to form in vivo gene editing pact “One year after Intellia’s landmark data, Novartis is making a play for the in vivo gene editing market. The move sees the Swiss pharma pay Precision BioSciences $75 million upfront in a combination of cash and equity investment along with up to $1.4 billion in milestones to secure rights to a potential treatment for sickle cell disease and beta thalassemia.”

About the public’s health

Healthiest Communities Rankings 2022 From U.S.News

 The Senate’s newly released gun deal  A great review of the terms of the deal.

 UK signs £1bn deal with Moderna for new vaccine centre “The UK government is collaborating with Boston-based Moderna to build the country’s first manufacturing centre for messenger RNA vaccines in a deal worth £1bn as it seeks to be a leader in responding to pandemics. The government is aiming to secure homegrown supplies of the mRNA technology that has proved a crucial weapon in the fight against Covid-19 and offers the prospect of transforming treatment for other conditions such as cancer.”

About healthcare IT

 New class action lawsuit claims Meta's discreet patient data tracker was active across 664 provider websites “The case was filed on Friday in the Northern District of California by an anonymous patient of Baltimore’s Medstar Health System on the behalf of “millions of other Americans whose medical privacy has been violated by Facebook’s Pixel tracking tool.”
The filing came just days after the publication of an investigation by The Markup detailing how the tech company’s analytics tool was found on roughly a third of the country’s top hospitals’ websites.
Both the report and the lawsuit detailed the tracker’s collection of identifiable information such as IP addresses alongside other potentially sensitive information including doctor names and recent web activity related to their health conditions.”

State by state, some patients are losing telehealth access to doctors “A year ago, 26 states still had pandemic-era waivers that allowed residents to have virtual visits with doctors who were based in other states, according to the Federation of State Medical Boards, which represents the licensing boards in U.S. states and territories.
Now, only 12 states still have their pandemic-era waivers, according to the federation. California, New Jersey and some of the other remaining states are scheduled to let their emergency waivers expire soon, the federation said. Nineteen more states have some long-term rules for interstate telemedicine, although they vary.”

VA hits pause on future rollouts of EHR until 2023 while lawmakers raise fresh concerns about patient safety risks “The VA acknowledged in a statement that there have been ‘unanticipated outages and system degradations’ from the onset of the new Oracle Cerner electronic medical record system rollout. The EHR system has been rolled out to three VA facilities to date.”

Today's News and Commentary

Dr. Paul M. Ellwood Jr., Architect of the H.M.O., Is Dead at 95Pioneer” is an oft overused term; but it certainly fit Dr. Ellwood.

About Covid-19

 Ventilation is crucial, but until recently it took a backseat to other covid measures A great review of this subject.

About health insurance

 UnitedHealth unit to pick up UK health tech company EMIS for $1.5B EMIS provides healthcare software, information technology and other services in the U.K., with a focus on primary care and pharmacy systems.  
Optum's U.K. business has worked in the country for 20 years supporting the state-run National Health Service (NHS), according to an announcement.”

Texas Supreme Court denies $3M premium tax refund to BCBS “The Texas Supreme Court ruled 5-4 on June 17 that Blue Cross Blue Shield of Texas cannot receive a $3 million tax refund from its stop-loss policies that reimburse self-insured employers because they are a form of health insurance, according to Law360.
In previous court rulings in favor of BCBS, the payer had argued that its stop-loss policies only covered employers and not individuals or groups, so therefore, the premiums were not taxable.
Texas' highest court, however, ruled that because the policies do cover more than individual and aggregate claims, the reimbursements are linked to care claims.”

3 in 10 U.S. workers struggling financially, WTW survey finds “Three in 10 U.S. workers (30%) are struggling financially, and more than two in five workers (43%) are having difficulty meeting basic needs, according to research from the 2022 Global Benefits Attitudes Survey by WTW…
Employee financial wellbeing has been deteriorating since the start of the pandemic. According to the survey, more employees are living paycheck to paycheck — 41% this year versus 38% in 2019. Among workers earning $100,000 or more, the number of employees living paycheck to paycheck doubled from 18% in 2019 to 36% this year. Over half of workers earning less than $50,000 (52%), single parents (53%), and those in poor or fair health (57%) are also living paycheck to paycheck. Additionally, employees living paycheck to paycheck are almost twice as likely to leave their employer for a 5% raise (48%) compared with those not living paycheck to paycheck (29%). The survey of more than 9,600 U.S. workers was conducted during December 2021 and January 2022.”

Justices validate denial of insurance coverage for outpatient dialysis “The case involved a coordination-of-benefits statute, which allocates the costs of medical care between private health plans and Medicare. In this particular case, the statute obligates private insurers to cover the costs of dialysis for the first 30 months after a patient is diagnosed with end-stage renal disease. Recognizing that insurers might try to force those (expensive) customers off their private plan and into the publicly funded Medicare system, Congress prohibited insurers from discriminating against patients with end-stage renal disease. Specifically, the statute provides that a plan ‘may not differentiate in the benefits it provides between individuals having end stage renal disease and other individuals covered by such plan.’
Marietta had the bright idea that it could solve this problem by providing unusually low reimbursement rates for outpatient dialysis. This is an effective way to lower the costs of customers with end-stage renal disease because about 99.5% of the patients that receive outpatient dialysis have end-stage renal disease. DaVita (one of the two largest dialysis providers in the United States) objected, arguing that discriminating against patients who receive outpatient dialysis is the same thing as discriminating against patients with end-stage renal disease. The lower courts agreed, but the Supreme Court rejected that argument by a 7-2 vote.”

Potential Medicare Part D Savings on Generic Drugs From the Mark Cuban Cost Plus Drug Company “In January 2022, the Mark Cuban Cost Plus Drug Company (MCCPDC) launched an online pharmacy selling more than 100 generic prescription drugs at the cost of ingredients and manufacturing plus 15% margin, $3 pharmacy dispensing fee, and $5 shipping fee. In some cases, these prices are lower than those paid by insurers, including Medicare…
In this cross-sectional study, Medicare could have conservatively saved up to $3.6 billion in 2020 by purchasing 77 generic drugs at MCCPDC prices… Our study was limited to the generic drugs sold by MCCPDC, which represent 25% of the approximately $38 billion in Medicare Part D generic drug spending in 2020.”

About hospitals and healthcare systems

 Outstanding Patient Experience Award  Just-released data by state from Healthgrades.

About the public’s health

 Biden administration is expected to move to cut nicotine in cigarettes “The Biden administration is expected as soon as Tuesday to announce it intends to issue a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to minimally or nonaddictive levels, according to an individual familiar with the situation…
 The decision to pursue a policy to lower nicotine levels marks the first step in a lengthy process, and success is not assured. It could take at least a year for the Food and Drug Administration, which regulates cigarettes, to issue a proposed rule, experts say. After that, the FDA would have to sift through comments from the public before issuing a final rule.”

Vitamin, Mineral, and Multivitamin Supplementation to Prevent Cardiovascular Disease and CancerUS Preventive Services Task Force Recommendation Statement Recommendation The USPSTF recommends against the use of beta carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements for the prevention of cardiovascular disease or cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of single- or paired-nutrient supplements (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. (I statement)”
Also of interest is an accompanying editorial: Multivitamins and Supplements—Benign Prevention or Potentially Harmful Distraction? One conclusion: “For multivitamins, proving the absence of a benefit is challenging and an I statement (ie, “insufficient” evidence) is not a recommendation for or against use. However, at best, current evidence suggests that any potential benefits of a multivitamin on reducing mortality are likely to be small. For example, for a healthy 65-year-old woman, who has a 9-year estimated mortality risk of about 8.0%, taking a multivitamin for 5 to 10 years might reduce estimated mortality risk to 7.5% (based on an odds ratio of 0.94).”

About healthcare IT

 Mayo Clinic, K Health team up to use AI for personalized hypertension treatment “…K Health developed a personalized hypertension treatment algorithm that uses de-identified data from the Mayo Clinic to help reduce the time between diagnosis and treatment. The data points include demographics, medical history, lab results, medications prescribed and outcomes.
The company worked with the Mayo Clinic’s digital healthcare initiative, Mayo Clinic Platform. The two organizations began working on the project in November 2020.”

A reimbursement framework for artificial intelligence in healthcare A really good review of the issues that determine payment for AI services.

Texas Tech Health Science Center's vendor breach affects 1.2 million patients “In December 2021, Eye Care Leaders learned that an unauthorized user had access to its myCare Integrity system, which contained patient files. 
On April 22, Eye Care Leaders informed Texas Tech University Health Science Center that some of the information obtained from their breach contained their patients' protected health information such as names, addresses, phone numbers, driver's license numbers, email, dates of birth, medical record numbers, health insurance information, Social Security numbers.”

Wearable Medical Device Market to Hit USD 132.5 billion by 2031| AI and 5G to Bolster Growth Potentials, Growth Plus Reports “Based on device type, the wearable medical device market has been segmented into: Monitoring & Diagnostic Devices and Therapeutic Devices…
Some of the prominent players operating in the global wearable medical device market includes:-

  • Koninklijke Philips N.V

  • Apple Inc

  • Fitbit, Inc

  • Omron Healthcare, Inc

  • Medtronic

  • Garmin Ltd

  • GE Healthcare

  • Sotera Wireless, Inc

  • BioTelemetry, Inc

  • Dexcom, Inc.”

About health technology

 FDA Designates Anumana’s Pulmonary Hypertension Software a Breakthrough Device “The Pulmonary Hypertension (PH) Early Detection Algorithm is a screening tool that offers early diagnosis of patients with pulmonary hypertension, which can often go unnoticed until the disease has advanced. The company developed the algorithm in collaboration with Johnson & Johnson subsidiary Janssen and the Mayo Clinic.
The software analyses data from 12-lead ECGs in primary care, urgent care and emergency room settings. It uses an AI software platform developed by Anumana’s parent company, nference, which contains more than 6 million de-identified patient records.”

Today's News and Commentary

About Covid-19

 CDC endorses coronavirus vaccines for children under 5 “CDC Director Rochelle Walensky endorsed the agency’s advisory panel’s unanimous recommendation to vaccinate all children as young as 6 months old with one of two vaccines — one by Moderna and the other by Pfizer and its German partner, BioNTech…
Doses began shipping Friday following the authorization by the Food and Drug Administration, which found both vaccines to be safe and effective.”
And in a related article: Comparing the Pfizer and Moderna Covid vaccines for young children

Florida providers now able to order COVID-19 vaccines for young kids “After Florida Gov. Ron DeSantis said the state would not employ any resources to support the rollout of COVID-19 vaccines for children under 5, the White House announced pediatricians, children's hospitals and other healthcare providers in Florida will be able to order the shots directly from the federal government…”

About health insurance

 CMS proposes payment decrease of $810M for home health in 2023 “The Centers for Medicare & Medicaid Services is proposing a 2.9% home health payment update ($560 million) for calendar year 2023. This update is expected to lead to a 4.2% decrease ($810 million) in Medicare payments…
The update equates to an estimated 6.9% decrease that reflects the ‘effects of the proposed prospective, permanent behavioral assumption adjustment of -7.69% ($1.33 billion decrease), and an estimated 0.2% decrease that reflects the effects of a proposed update to the fixed-dollar loss ratio (FDL) used in determining outlier payments ($40 million decrease),’ CMS said.
CMS also is proposing a 5% cap on negative wage index changes, regardless of the underlying reason for the decrease, for home health agencies.”

About pharma

 Pfizer to buy 8.1 percent stake in French vaccines company Valneva “U.S. healthcare giant Pfizer has agreed to invest 90.5 million euros ($95.24 million) to buy an 8.1% percent stake in French vaccines company, as the companies announced developments in their partnership to tackle the Lyme disease.”

FTC to Ramp Up Enforcement Against Any Illegal Rebate Schemes, Bribes to Prescription Drug Middleman That Block Cheaper Drugs “The Federal Trade Commission announced that it will ramp up enforcement against any illegal bribes and rebate schemes that block patients’ access to competing lower-cost drugs. The enforcement policy statement issued today puts drug companies and prescription drug middlemen on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws. The agency will use its full range of legal authorities to combat illegal prescription drug practices that foreclose competition and harm patients.”

About the public’s health

Political environment and mortality rates in the United States, 2001-19: population based cross sectional analysis “What this study adds

  • Between 2001 and 2019, mortality rates decreased by 22% in Democratic counties but by only 11% in Republican counties

  • Male and female residents of Democratic counties experienced both lower mortality rates and twice the relative decrease in mortality rates than did those in Republican counties. Black Americans experienced largely similar improvement in age adjusted mortality rates in both Democratic and Republican counties. However, the mortality gap between white residents in Democratic versus Republican counties increased fourfold

  • Rural Republican counties experienced the highest mortality rates and the least improvement. All trends were similar when comparing counties that did not switch political environment throughout the period, and when governor election results were used

  • The greatest contributors to the rising mortality gap between Republican and Democratic counties were heart disease, cancer, chronic lower respiratory tract diseases, unintentional injuries, and suicide” 

Today's News and Commentary

100 Million People in America Are Saddled With Health Care Debt “In the past five years, more than half of U.S. adults report they’ve gone into debt because of medical or dental bills, the KFF poll found.
A quarter of adults with health care debt owe more than $5,000. And about 1 in 5 with any amount of debt said they don’t expect to ever pay it off.”

About Covid-19

FDA authorizes coronavirus vaccine for young kids with shots likely next week “More than a year and a half after the oldest Americans gained access to coronavirus vaccines, the nation’s youngest citizens are poised to start getting shots next week, a move made possible when federal regulators Friday authorized vaccines for children as young as 6 months.”

Congressional covid funding deal appears ‘dead’ after GOP criticism “A congressional deal for billions of dollars in additional coronavirus funding appeared all but dead Thursday after Senate Republicans accused the White House of being dishonest about the nation’s pandemic funding needs.
Sen. Mitt Romney (R-Utah), who brought the Senate close to a bipartisan $10 billion covid funding deal in March, said the Biden administration had provided “patently false” information about its inability to buy additional vaccines, treatments and supplies. He cited a newly announced White House plan to repurpose some existing funds to cover the country’s most pressing vaccine and treatment needs.”

WHO set to back use of Covid variant-specific vaccines as third shot “The interim advice could be published as early as Friday, according to the people. The WHO did not respond to specific questions and said it was ‘aware’ that a statement from the technical group was ‘forthcoming’. The WHO would only make a real-world policy recommendation once safety and other data had become available for variant-specific vaccines, the people said. No variant-specific vaccine is on the market.”

Surveys for compliance with Omnibus COVID-19 Health Care Staff Vaccination Requirements CMS is changing the frequency of reporting Covid-19 vaccinations. “Survey oversight of the staff vaccination requirement for Medicare and Medicaid- certified providers and suppliers will continue to be performed during initial and recertification surveys, but will now only be performed in response to complaints alleging non-compliance with this requirement, not all surveys. Under prior guidance, all surveys included oversight of the staff vaccination requirement.”

 DeSantis says Florida is ‘affirmatively against’ Covid-19 vaccines for young kids “Florida GOP Gov. Ron DeSantis on Thursday railed against providing Covid-19 vaccines to young children, saying Florida will not provide state programs to administer vaccinations for toddlers or infants.
DeSantis, speaking at a press conference in Miami, said that Covid-19 vaccines have not gone through enough testing and clinical trials to determine that they are effective and added that kids are least likely to suffer serious health consequences from Covid.” 

Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections “The effectiveness of previous infection alone against symptomatic BA.2 infection was 46.1%…The effectiveness of three doses of BNT162b2 and no previous infection was 52.2%... The effectiveness of previous infection and two doses of BNT162b2 was 55.1%…, and the effectiveness of previous infection and three doses of BNT162b2 was 77.3%... Previous infection alone, BNT162b2 vaccination alone, and hybrid immunity all showed strong effectiveness (>70%) against severe, critical, or fatal Covid-19 due to BA.2 infection. Similar results were observed in analyses of effectiveness against BA.1 infection and of vaccination with mRNA-1273.”

Risk of long COVID associated with delta versus omicron variants of SARS-CoV-2 “Overall, we found a reduction in odds of long COVID with the omicron variant versus the delta variant of 0·24–0·50 depending on age and time since vaccination. However, the absolute number of people experiencing long COVID at a given time depends on the shape and amplitude of the pandemic curve.”

 WTO ministers reach deals on fisheries, food, COVID vaccines “More controversial was an agreement on a watered-down plan to waive intellectual property protections for COVID-19 vaccines, which ran afoul of advocacy groups that say it did not go far enough — and could even do more harm than good.”

About health insurance

MedPAC’s June Report to Congress This version summarizes the extensive research and commentary that is in the full version of this annual report.

Cigna Announces $3.5 Billion Accelerated Stock Repurchase Agreements The headline is the story. 

About pharma

 Whistleblower suit: CVS prevented Part D members from accessing generics “A newly unsealed whistleblower suit claims that multiple CVS Health subsidiaries coordinated to prevent members from accessing generic drugs in a bid to boost the bottom line.
The suit, first obtained by Stat, was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. Miller says that when she reported the behavior to a superior, she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught.
Miller claims that CVS' SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.”

About healthcare IT

 Epic Announces Plan to Join TEFCA, Champion Next Step in Evolution Toward Universal Interoperability “Epic is announcing its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.
Epic collaborated with ONC, The Sequoia Project, and the broader healthcare community to build consensus around the principles and procedures of TEFCA. When the application process opens later this year, Epic will apply to join TEFCA as an inaugural Qualified Health Information Network.”