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 subvariants “Moderna 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 inequities “Inequities 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 95 “Pioneer” 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.”

Today's News and Commentary

About Covid-19

 Labcorp COVID-19 Test That Can Identify Viral Strains Gets EUA “The FDA has granted Emergency Use Authorization (EUA) to Laboratory Corporation of America’s Labcorp VirSeq SARS-CoV-2 next-generation sequencing test, which can differentiate between different strains of the virus that causes COVID-19.
The test analyzes positive samples identified using the company’s COVID-19 real-time polymerase chain reaction test, or its SARS-CoV-2 & Influenza A/B assay.”

About health insurance

 Anthem launches Carelon, Wellpoint ahead of Elevance Health rebrand “Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it's also launching new brands for two of its subsidiaries.
The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word "care" with the suffix "lon," which means full or complete, representing the company's ambition to offer an end-to-end care experience.
Carelon will include Anthem's in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.”

Inaccuracies in Medicare’s Race and Ethnicity Data Hinder the Ability To Assess Health Disparities Form the HHS OIG: “Medicare’s enrollment race and ethnicity data are less accurate for some groups, particularly for beneficiaries identified as American Indian/Alaska Native, Asian/Pacific Islander, or Hispanic. Data that are not accurate limit the ability to assess health disparities. Limited race and ethnicity categories and missing information contribute to inaccuracies in the enrollment data. Although the use of an algorithm improves the existing data to some extent, it falls short of self-reported data. Finally, Medicare’s enrollment data on race and ethnicity are inconsistent with Federal data collection standards; these inconsistencies inhibit the work of identifying and improving health disparities within the Medicare population…
Accordingly, we recommend that CMS:
(1) develop its own source of race and ethnicity data, (2) use self-reported race and ethnicity information to improve data for current beneficiaries, (3) develop a process to ensure that the data are as standardized as possible, and (4) educate beneficiaries about CMS’s efforts to improve the race and ethnicity information. CMS did not explicitly concur with the first recommendation and concurred with the other three recommendations.”

About pharma

 Pharmacy retail giant Walgreens looks to disrupt the clinical trials business Interesting read about how Walgreens will accomplish this goal.

About the public’s health

Biden launches plan to protect transgender youths’ health care “President Joe Biden on Wednesday will order his health agency to begin efforts to ban conversion therapy and expand access to gender-affirming treatment after a slew of state attempts to limit transgender health care, particularly for children.
The president’s executive order will call on the Department of Health and Human Services to clarify that federally funded programs cannot offer conversion therapy, a widely discredited practice that attempts to change a person’s sexual orientation or gender identity, and work on a public information campaign about the practice. Biden is also directing HHS to take “steps to address the barriers and exclusionary policies” to different types of health care and treatment.”

About healthcare IT

 Facebook Is Receiving Sensitive Medical Information from Hospital Websites “The Markup tested the websites of Newsweek’s top 100 hospitals in America. On 33 of them we found the tracker, called the Meta Pixel, sending Facebook a packet of data whenever a person clicked a button to schedule a doctor’s appointment. The data is connected to an IP address—an identifier that’s like a computer’s mailing address and can generally be linked to a specific individual or household—creating an intimate receipt of the appointment request for Facebook…
 The Markup also found the Meta Pixel installed inside the password-protected patient portals of seven health systems.”
Read the entire article. Researchers solicited comments from hospitals found to have this tracker. Many said they would remove it. The “lamest” response was from Northwestern Memorial: “The use of this type of code was vetted and is referenced in NM.org’s Terms and Conditions.” —Christopher King, chief media relations executive. I have a MyChart account at this hospital and was not given the opportunity to “opt out.”

Today's News and Commentary

Universal healthcare as pandemic preparedness: The lives and costs that could have been saved during the COVID-19 pandemic “Universal healthcare could have alleviated the mortality caused by a confluence of negative COVID-related factors. Incorporating the demography of the uninsured with age-specific COVID-19 and nonpandemic mortality, we estimated that a single-payer universal healthcare system would have saved 212,000 lives in 2020 alone. We also calculated that US$105.6 billion of medical expenses associated with COVID-19 hospitalization could have been averted by a Medicare for All system.”

About Covid-19

FDA advisers recommend greenlighting coronavirus vaccines for young kids “Independent advisers to the Food and Drug Administration on Wednesday recommended the use of the Moderna and Pfizer-BioNTech coronavirus vaccines for babies and young children, a milestone in the nation’s efforts to combat a wily pathogen that continues to infect tens of thousands of people a day and upend the lives of countless families across the country.”

 FDA advisers vote in favor of authorizing Moderna Covid-19 vaccine for ages 6-17 “Vaccine advisers to the US Food and Drug Administration decided unanimously Tuesday in favor of expanding the emergency use authorization of Moderna's Covid-19 vaccine to include older children and teens, ages 6 to 17, saying it would offer more benefits than risks.”

Pfizer halts Paxlovid trial for standard-risk patients “Pfizer-BioNTech will stop adding patients to its Paxlovid phase 2/3 trial after failing to prove the antiviral treatment reduced the relative risk of contracting COVID-19. 
The drugmaker could not produce statistically significant data on whether the nation's most prescribed COVID-19 treatment was effective in reducing the risk of hospitalizations and deaths, according to a June 14 news release…
The company said in the release that it plans to continue testing Paxlovid's efficacy in high-risk populations.”

About hospitals and healthcare systems

US Supreme Court overturns $1.6B 340B payment cut “The case centered [on] whether CMS has the authority to make cuts to the program under its  Medicare Outpatient Prospective Payment System. Under the payment rule, HHS cut the reimbursement rate for covered drugs by 28.5 percent in 2018, but it later lowered the reimbursement rate cut to 22.5 percent. 
Under the 340B program, eligible hospitals can buy outpatient drugs at a discount. A hospital typically pays 20 percent to 50 percent below the average sales price for the drugs through the program.”

 Financial updates from 20 health systems FYI

About pharma

 Mental-Health Startup Cerebral Investigated by FTC  The “FTC said it was investigating whether Cerebral engaged in deceptive or unfair practices related to advertising or marketing of mental-health services. The letter also directed the company to preserve documents.” See previous posts for the back story that led to this action.

Did J&J and BMS conspire on blood thinner price hikes? Congressional leaders want DOJ, FTC to look into it: report “When Johnson & Johnson’s Xarelto entered the market in 2011 and Bristol Myers Squibb’s Eliquis did the same in 2013, list prices for the popular blood thinners were $218 and $250, respectively, for a monthly supply.  
But by January of this year, those prices had mushroomed to $516 for Xarelto and $529 for Eliquis. As a result, Medicare Part D has spent more than $46 billion on the drugs since 2015, according to a report (PDF) from Patients for Affordable Drugs.”

About the public’s health

 Air pollution cuts life expectancy by more than two years, study says Highlights:
—97% of world lives in areas where pollution exceeds safe levels
—South Asians lose 5 years of life due to smog
—No country met WHO's air-quality standard in 2021 
For a more detailed analysis of the problem, see: AIR QUALITY LIFE INDEX® | JUNE 2022 [Annual Update]

EPA warns toxic ‘forever chemicals’ more dangerous than once thought “The Environmental Protection Agency warned Wednesday that a group of human-made chemicals found in the drinking water, cosmetics and food packaging used by millions of Americans pose a greater danger to human health than regulators previously thought.
The new health advisories for a ubiquitous class of compounds known as polyfluoroalkyl and perfluoroalkyl substances, or PFAS, underscore the risk facing dozens of communities across the country. Linked to infertility, thyroid problems and several types of cancer, these “forever chemicals” can persist in the environment for years without breaking down.”

Trends in Health Care Use Among Black and White Persons in the US, 1963-2019 “This study’s findings indicate that racial inequities in care have persisted for 6 decades and widened in recent years, suggesting the persistence and even fortification of structural racism in health care access. Reform efforts should include training more Black health care professionals, investments in Black-serving health facilities, and implementing universal health coverage that eliminates cost barriers.”

Today's News and Commentary

About Covid-19

 Covid is making flu and other common viruses act in unfamiliar ways Common viruses appear more virulent than before Covid-19 and are occurring at times of the year they were not usually seen.

About health insurance

 Orlando Health alleges healthcare sharing ministry told patients to hide membership for cheaper care “Florida-based nonprofit health system Orlando Health has sued faith-based healthcare-sharing ministry Liberty HealthShare, alleging that the organization instructed patients to hide their memberships in order to secure reduced rates for their care.”
This article is a great case study of a typical “ healthcare-sharing ministry.”

Spotlight on Medicare Advantage: An eHealth Survey June 2022 Some highlights:
—88% of enrollees express satisfaction with their Medicare Advantage plan, and 86% would recommend Medicare Advantage to family or friends; only 6% express dissatisfaction with their plan.
—Two thirds (67%) of those who chose Medicare Advantage over Medigap did so because Medigap was too expensive. If forced to look for similar coverage elsewhere, 73% of Medicare Advantage enrollees say they could afford monthly premiums of no more than $50.”
The latter finding might explain the first one.

Humana launches rebranded pharmacy businesses “Humana's pharmacy and specialty pharmacy businesses are now under its CenterWell brand. 
Humana Pharmacy and Humana Speciality Pharmacy will now be known as CenterWell Pharmacy and CenterWell Specialty Pharmacy, according to a June 13 Humana news release. 
The insurer's pharmacy benefit manager, Humana Pharmacy Solution, is keeping its name, according to the news release. Enclara Pharmacia, which provides pharmacy management services for the hospice industry, is also keeping its name.”

About hospitals and healthcare systems

 Best Children's Hospitals 2022-2023 Honor Roll and Overview FYI- from US News.

About pharma

 The top 10 most profitable pharma companies in 2021 Ranked by earnings not sales. “With $24 billion in net income, Novartis was unexpectedly the most profitable pharma company in 2021, beating Pfizer and J&J, which recorded $22 billion and $21 billion, respectively. While Novartis did improve its profit margins as a percentage of sales, it was one special item that helped nearly triple the Swiss pharma’s net profit.”

Basaglar 'Copycat' Insulin for Diabetes Has Advantages Over Lantus “The follow-on or copycat insulin glargine product Basaglar (Lilly) is similar to brand-name Lantus (Sanofi) in terms of efficacy and safety for the treatment of type 2 diabetes, but Basaglar cost less and had better adherence, new real-world data show.”
The article did not give the price of new medication.

Lilly, Incyte win FDA okay for first systemic alopecia areata treatment in US “The FDA announced Monday that it cleared Eli Lilly and Incyte's oral JAK1/JAK2 inhibitor Olumiant (baricitinib) for adults with severe alopecia areata, making it the first approval in the US of a systemic treatment for the condition. Kendall Marcus, director of the dermatology division at the FDA's Center for Drug Evaluation and Research, said the decision "will help fulfill a significant unmet need."
The priority review filing was backed by results from the placebo-controlled Phase III BRAVE-AA1 and BRAVE-AA2 trials of patients who had ≥50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months. Participants were randomised to receive Olumiant, at doses of 2mg or 4mg, or placebo every day.”

About the public’s health

Tobacco companies will be forced to reduce nicotine in U.S. cigarettes until they’re non-addictive, if the Biden administration has its way: report “Tobacco companies will be forced to reduce nicotine in cigarettes sold in the U.S. to nonaddictive, or minimally addictive, levels, if the Biden administration has its way.
The policy could be announced as early as this coming week, The Wall Street Journal reported Friday. But it likely won't take effect for several years. The U.S. Food and Drug administration would have to draft a proposed rule and open it for public comment. After it published the rule, tobacco companies could sue, delaying implementation.
Meanwhile, the U.K. government is considering raising the legal age for smoking each year until smoking is effectively outlawed, Bloomberg reported this week, adding that New Zealand plans a similar move that will eventually prohibit smoking.”

Brain lesions disrupting addiction map to a common human brain circuit  “We analyzed two cohorts of patients addicted to smoking at the time of focal brain damage (cohort 1 n = 67; cohort 2 n = 62)…
 Lesions disrupting smoking addiction occurred in many different brain locations but were characterized by a specific pattern of brain connectivity…
 We conclude that brain lesions disrupting addiction map to a specific human brain circuit and that hubs in this circuit provide testable targets for therapeutic neuromodulation.”

About healthcare IT

The harm of class imbalance corrections for risk prediction models: illustration and simulation using logistic regression “Methods to correct class imbalance (imbalance between the frequency of outcome events and nonevents) are receiving increasing interest for developing prediction models. We examined the effect of imbalance correction on the performance of logistic regression models…
Imbalance correction led to models with strong miscalibration without better ability to distinguish between patients with and without the outcome event. The inaccurate probability estimates reduce the clinical utility of the model, because decisions about treatment are ill-informed… imbalance correction may even worsen model performance.”

Guidance on How the HIPAA Rules Permit Covered Health Care Providers and Health Plans to Use Remote Communication Technologies for Audio-Only Telehealth “The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) developed this guidance to help covered entities understand how they can use remote communication technologies for audio-only telehealth in compliance with the HIPAA Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth Remote Communications (Telehealth Notification) is no longer in effect.”
I find it amusing that landline calls are exempt because they do not involve electronic communication as defined by HIPAA.

Arizona hospital says SSNs of 700,000 people leaked during April ransomware attack “In letters to victims recently made public, Yuma Regional Medical Center (YRMC) said it discovered a ransomware attack on April 25 and immediately took systems offline before contacting cybersecurity experts and law enforcement.”

Kaiser Permanente notifies nearly 70,000 patients of email data breach “Kaiser Permanente is notifying 69,589 patients of a data breach that occurred when someone accessed an employee's emails.
The emails contained protected health information, including first and last names and lab test results, but the health plan said it had no indication that the data was accessed or misused.”

Top 10 medical marketing agencies by revenue FYI
Comment from my co-author (Strategic Marketing for Health Care Organizations), Robert Stevens: “Many of these companies are in actuality pharma and medtech ad agencies.  Marketing is a stretch. 
An exception is nearby [he lives in N.C.] Syneos Health.  It’s been a CRO [contract research organization] since 1999.  Today Syneos does not want to be positioned as a CRO.  It’s current positioning is as a ‘Biopharmaceutical Acceleration Model’ or BAM organization.  That may be a good differentiator.  The value prop, however, seems muddy.”

About healthcare finance

 Where investment dollars are flowing in biotech startups “Biotech startups that utilize platform-based therapeutics received a large proportion of investment dollars from 2019 to 2021, according to a June 10 McKinsey article…
Here are five platform-based startup types to watch, as they received the most VC investment:

1. Cell therapy represented $7.7 billion of total funding.

2. Next-generation gene therapies brought in $7.6 billion in funding.

3. Precision medicine companies got $4.5 billion in funding.

4. Machine-learning-enabled drug discovery brought in $4.4 billion.

5. Startups focusing on hard-to-hit targets, or "undruggable" targets, got $4 billion in funding.”

Today's News and Commentary

The Role Of Clinical Waste In Excess US Health Spending “Top Findings From The Literature

• Clinical waste is caused by failures of care delivery, failures of care coordination, and overtreatment, accounting for 5.4–15.7 percent of all health spending in the US.

• Failures of care delivery account for 2.7–5.7 percent of total US health spending.

• Failures of care coordination account for 0.7–2.1 percent of total US health spending.

• Overtreatment accounts for 2.0–8.4 percent of total US health spending.”

About Covid-19

Pfizer-BioNTech shot for children under 5 safe and effective, FDA staff says “The analysis by FDA scientists was released ahead of a meeting Wednesday of the agency’s independent experts, who will consider a request for emergency use authorization for the Pfizer-BioNTech vaccine in the youngest children. It will also review a request from Moderna to use its vaccine in children younger than 6. FDA staff Friday said Moderna’s shot for infants and young children was safe and effective.”

 COVID DATA TRACKER WEEKLY REVIEW “As of June 8, 2022, the current 7-day moving average of daily new cases (109,032) increased 8.0% compared with the previous 7-day moving average (100,916). A total of 85,084,715 COVID-19 cases have been reported in the United States as of June 8, 2022.” 

About hospitals and healthcare systems

 How did 7 gallons of fentanyl go missing from a hospital? Regulators launch investigation “State regulators have suspended the licenses of several leaders at Cheshire Medical Center in Keene, N.H., as they investigate how more than seven gallons of fentanyl went missing from the hospital across a four-month period. On June 29, the hospital will find out whether the state's pharmacy board is suspending or revoking its pharmacy permit.” 

About pharma

 U.S. Supreme Court Rebuffs Opioid Maker Insys Founder's Conviction Appeal “The U.S. Supreme Court on Monday rejected bids by Insys Therapeutics Inc founder John Kapoor and another former executive of the drugmaker to overturn their convictions for conspiring to bribe doctors to prescribe addictive opioids and defraud insurers into paying for them” 

CBER Aims to Resume Normal Operations in 2023 “The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023…”

About the public’s health

 Inhaled vaccines offer better protection than nasal sprays, study shows “For the study, published online in the journal Frontiers in Immunology, the researchers used a tuberculosis vaccine to compare delivery methods by measuring the distribution of droplets, immune responses and potency in animals.When the vaccine was delivered directly into the lungs it stimulated stronger immune responses, providing much better protection from TB.” 

Three articles illustrate the complexity of addressing dietary issues for the public’s health

Calorie counts on menus: Have they helped?“‘Labeling did not have any impact that we could observe on people’s food purchasing behaviors,’ said study author Brian Elbel, a professor of population health and health policy at New York University.”

 Diet quality, energy intake do not mediate link between food insecurity and obesity “In findings from the 2015-2016 National Health and Nutrition Examination Survey, adults experiencing food insecurity had a higher BMI and waist circumference than food-secure individuals. However, energy intake did not explain the associations with BMI or waist circumference, and diet quality only partially mediated the association between food insecurity and waist circumference.”

Association of Socioeconomic and Geographic Factors With Diet Quality in US Adults “In this cross-sectional analysis of 155 331 adults participating in a nationwide US cohort study, Black individuals, White individuals with limited income, participants with low educational attainment, and people living in rural areas or food deserts were more likely to have overall poor diet quality. All dietary components, but especially sugar-sweetened beverages and processed meats, contributed to the disparities observed.”

About healthcare IT

 Startup gets green light to use Apple Watch to track Parkinson’s symptoms “The StrivePD system uses Apple’s Movement Disorder API to track tremors and dyskinetic symptoms of Parkinson’s from the Apple Watch. The data is all collected in an iPhone application, which allows patients to record their symptoms and keep tabs on medication.” 

About healthcare personnel

 ‘The New Nurse’ Is the New Normal “Key Findings

• Between March 2021 and March 2022, median nursing tenure fell by 19.5%.

• Shifts covered by nurses new to the organization in the last 30 days increased in all regions.

• The number of 12-hour shifts filled by nurses new to the organization within the last year also rose by 55.5%.” 

Today's News and Commentary

About Covid-19

 U.S. to lift coronavirus testing requirement for flyers returning to the country “International travelers flying to the United States will no longer need to show proof of a negative coronavirus test before boarding their flights to the U.S., a senior Biden administration official said Friday, ending one of the nation’s last pandemic-related travel requirements.
The requirement will end at 12:01 a.m. Sunday.”

About health insurance

 Disparities in Health Care Spending and Utilization Among Black and White Medicaid Enrollees “In this cross-sectional study of 1 966 689 Black and White Medicaid enrollees in 3 states, Black enrollees used fewer services, including primary care, and generated lower spending than White enrollees, but were more likely to utilize the emergency department for avoidable reasons. Differences persisted among enrollees residing in the same zip codes who were treated by the same health care professionals.”

About pharma

 New Drug Prices Soar to $180,000 a Year on 20% Annual Inflation “The median launch price of a new drug in the US soared from $2,115 in 2008 to $180,007 in 2021, a 20% annual inflation rate over the period, researchers at Harvard-affiliated Brigham and Women’s Hospital in Boston found. Even after adjusting for factors such as drugmakers’ focus on expensive disease categories like cancer and estimated discounts that manufacturers give some purchasers, the annual inflation rate in launch prices over the period was still almost 11%…
 Over 47% of new drugs introduced in 2020 and 2021 cost more than $150,000 per year, compared to just 9% of new drugs from 2008 to 2013, the researchers found.”

 CVS study: Using evidence-based guidelines may decrease total cost of cancer care “Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients…
The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.
In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.”

The Facts About Medicare Spending A great overview of current Medicare stats from the KFF.

Bluebird bio's gene therapy for blood disorder gets FDA panel backing ”The panel of 13 outside experts on Friday voted unanimously for beti-cel as a one-time gene therapy to treat Beta-thalassemia patients dependent on blood transfusions.
The FDA is expected to decide on beti-cel's fate by Aug. 19 and eli-cel's by Sept. 16.”

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 “This cross-sectional study found that of 89 new oncology therapies approved by both the FDA and EMA from 2010 to 2019, the FDA approved 95% of therapies first, with a median delay to market authorization in Europe of 241 days…
The FDA received licensing applications sooner and had shorter review times. However, more therapies were approved prior to licensing study publication, leaving uncertainty for practitioners regarding clinical utility and safety of newly approved therapies.”
An accompanying editorial (The Timing of Cancer Drug Approvals in the United States and Europe) notes, among other things: “Although the speed of FDA review times and subsequent number of approvals have increased over time, the proportion of cancer drugs that improve survival has declined. Furthermore, although other countries approve fewer medicines than the US, available therapies tend to offer more benefit to patients.” In other words, quality not quantity or speed.

How to Retain Employees by Offering the Right Health Benefits “To prevent employees from becoming another statistic in the Great Resignation, companies may want to revisit the health benefits they offer. Some small business owners are embracing a perk once rarely found outside of the U.S. military--no-cost health insurance…
Nearly half of the 475 companies on Inc.'s 2022 Best Workplaces list now offer entirely employer-paid health insurance. And 90 percent of employers rank health as the benefit their workforce values the most, according to the Society for Human Resource Management Benefits Survey.”
Read the article for examples.

About the public’s health

GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults Key findings:

• “First RSV vaccine candidate to show statistically significant and clinically meaningful efficacy in adults aged 60 years and above

• The magnitude of effect observed was consistent across RSV A and B strains, key secondary endpoints and in those aged 70 years and above”

European Commission and United States sign cooperation arrangement on preparedness and response to public health threats “Following the statement by President Ursula von der Leyen and U.S. President Joe Biden marking the second Global COVID-19 Summit, the European Commission and the U.S. Department of Health and Human Services have signed an arrangement to strengthen cooperation on preparedness and response to public health threats. This will enable the Commission and the U.S. to work together on a broad range of topics to jointly tackle health emergencies, contributing to establishing a strong global health architecture.”

 Takeda's dengue vaccine shows continued efficacy through 4.5 years “Takeda on Thursday reported results from a long-term exploratory analysis indicating that its dengue vaccine TAK-003 continued to protect against illness and hospitalisations from the mosquito-borne infection 4.5 years after immunisation in the Phase III TIDES study, with no important safety risks emerging. The tetravalent vaccine candidate, which is based on a live-attenuated dengue serotype 2 virus, is currently undergoing regulatory review for the prevention of dengue disease in children and adults in the EU and select dengue-endemic countries.”

About healthcare personnel

 Trends and Disparities in the Distribution of Outpatient Physicians’ Annual Face Time with Patients, 1979–2018 “Our sample included n = 1,108,835 patient visits. From 1979 to 2018, annual outpatient physician face time per capita rose from 40.0 to 60.4 min, an increase driven by a rise in mean visit length and not in the number of visits. However, since 2005, mean annual face time with a primary care physician has fallen, a decline offset by rising time with specialists. Face time provided per physician changed little given growth in the physician workforce. A racial/ethnic gap in physician visit time present at the beginning of the study period widened over time. In 2014–2018, White individuals received 70.0 min of physician face time per year, vs. 52.4 among Black and 53.0 among Hispanic individuals. This disparity was driven by differences in visit rates, not mean visit length, and in the provision of specialist but not primary care.”

Today's News and Commentary

About Covid-19

 Biden Administration Announces Operational Plan for COVID-⁠19 Vaccinations for Children Under 5 “The Biden Administration’s plan includes: 
—Securing vaccine supply for our nation’s children. The Administration has procured a significant supply of vaccines for this age group, with 10 million doses available initially and millions more available in the coming weeks…
—Making vaccinations available in convenient places parents and families know and trust. Working with states, localities, Tribes and territories, the Administration will make vaccinations for our nation’s youngest children widely available at thousands of trusted, accessible sites across the country—with 85 percent of children under the age of five living within five miles of a potential vaccination site…
—Leveraging federal programs to reach parents and families with information and advance equity. As with prior vaccination efforts, the Administration will leverage existing federal programs and capabilities to ensure that we are reaching parents and families with the information they need…
—Supporting education and engagement efforts to build trust among parents and families…To ensure that parents and families have answers to their questions and information from sources that they trust, HHS will work with a broad range of national organizations to launch a national public education campaign that reaches parents, guardians, and families with facts and information that they need to make informed choices for both their youngest and their older children…”

Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 “Molnupiravir-treated participants had a decreased need for respiratory interventions versus placebo-treated participants (relative risk reduction [RRR], 34.3%…), with similar findings in participants who were hospitalized after randomization (RRR, 21.3%…). Hospitalized participants who received molnupiravir were discharged a median of 3 days before those who received placebo. Acute care visits (7.2% vs. 10.6%; RRR, 32.1%…) and COVID-19–related acute care visits (6.6% vs. 10.0%; RRR, 33.8%…) were less frequent in molnupiravir- versus placebo-treated participants.”

About health insurance

 CMS: Payers that cut or reduce agent commissions are violating the ACA “Payers that reduce or eliminate compensation for insurance agents and brokers who help enroll people in ACA plans during a special enrollment period are in violation of the ACA, according to a FAQ published by CMS on June 7.
The move comes after reports of Bright Healthcare, Oscar Health, Molina Healthcare and some Blue Cross companies cutting or limiting agents' commissions after record ACA enrollment earlier this year.”

Medicare FFS Claims: 2% Payment Adjustment (Sequestration) Changes A reminder that at the end of the month, the sequester goes back up to 2%. Here is a recent history:
The Protecting Medicare and American Farmers from Sequester Cuts Act impacts payments for all Medicare Fee-for-Service (FFS) claims:

• No payment adjustment through March 31, 2022

• 1% payment adjustment April 1 – June 30, 2022

• 2% payment adjustment beginning July 1, 2022

Pharmaceutical company to pay $12.9M to settle Texas Medicaid fraud claim Dr. Reddy's Laboratories, an “India-based multinational pharmaceutical manufacturer has agreed to pay $12.9 million to settle claims it reported inflated prices to the Texas Medicaid program, the Texas attorney general said June 8.”
The “alleged inflated price-reporting began in October 2003, according to the settlement agreement.”

About hospitals and healthcare systems

 Two hospitals are being fined for disobeying price transparency rules  After a grace period, CMS is finally enforcing this requirement. “The agency sent letters, dated Tuesday, to both hospitals detailing the alleged violations and the fines. (Hospital officials didn’t respond to a request for comment as of publication time.) Here's what CMS wrote in letters quietly posted online Wednesday: 

• Neither hospital posted a comprehensive list of standard charges.

• For Northside Hospital Cherokee, agency officials couldn’t find a consumer-friendly list of 300 shoppable services.

• Northside Atlanta Hospital told CMS that patients should call or email for price estimates.”

Reimagining Primary Health Care after COVID-19 (A monograph from the World Bank Group)
Most countries (with the notable exception of the U.S.) build their healthcare systems around the provision of primary care. But even those countries have not lived up to the promises of such a design. Here is a summary of this extensive document:
”In this report, we argue that a robust and reimagined primary health care (PHC) agenda, as part of a broader reinvigoration of UHC [universal health coverage], must be part of the post-COVID-19 story—both to dig the world out of the COVID-19 ditch and to prevent similar catastrophes in the future. To be clear, we do not claim that the COVID-19 crisis was entirely or mostly the result of weak or nonfunctional PHC services. Yet PHC was often the weakest link in the national and community responses, despite its critical importance as a backstop to ‘flatten the curve’ and prevent hospital saturation. Core PHC functions such as surveillance, testing, and contact tracing first fell through the cracks and then were ultimately assumed by newly created teams or by hospitals. Now we will again need PHC to close the COVID-19 chapter and make up for lost time—by administering vaccines against COVID-19; recouping losses to reproductive health, preventive care, and mental health; and building back better to meet the evolving needs of the global population.
[The report] builds on the vast literature on PHC, revisiting the concept, its underpinnings, country experiences, and lessons learned. The report also is fully aligned with the 2018 Declaration of Astana on PHC as the main pillar of universal health coverage and the health-related Sustainable Development Goals… its emphasis is on the ‘how’—what it takes to build a fit-for-purpose primary health care service delivery platform—and it spells out how countries could reimagine it…”

About pharma

 Generic drugmakers win one, lose one in sweeping price-fixing case involving 49 states, 20 companies “On Tuesday, a federal district court judge in Pennsylvania ruled (PDF) that states were not entitled to a cut of the profits generics manufacturers allegedly made from their scheme.
Judge Cynthia Rufe said that disgorgement was not an available avenue for the states to pursue under federal antitrust laws.
But it wasn’t a complete victory for the drugmakers. Rufe also rejected the companies’ attempt to dismiss the states’ effort to score injunctive relief, which would allow the court to intervene in their operations…
Most of the world’s prolific makers of generics are named in the case including Teva, Sandoz, Par Pharmaceuticals and Mylan (now Viatris).”

About the public’s health

STATNEWS reviewed highlights from the just-concluded American Society of Clinical Oncology (ASCO) annual meeting.

 More than 1,000 monkeypox cases reported to WHO - briefing “WHO Director-General Tedros Adhanom Ghebreyesus said the risk of monkeypox becoming established in these non-endemic countries was real but preventable at this point.
Twenty-nine countries have reported cases in the current outbreak, which began in May. None have reported deaths. 
At a media briefing in Geneva, Tedros also said there had been more than 1,400 suspected cases of monkeypox this year in Africa and 66 deaths…
Rosamund Lewis, WHO technical lead on monkeypox, said that "interpersonal close contact" was the main way monkeypox spreads, although she added that the risk of aerosol transmission was not yet fully known. Health workers caring for monkeypox patients should wear a mask, she said.”

About healthcare personnel

 Use of a Real-Time Locating System [RTLS] to Assess Internal Medicine Resident Location and Movement in the Hospital “In this cross-sectional study, 43 internal medicine interns wore an RTLS badge during the 2018-2019 academic year with usable data. Interns spent only 13.4% of their time in patient rooms; there was significant interindividual variation in bedside time and significant interservice differences in time spent in patient rooms during rounds, with most time spent in the hallway or the workroom…
By some estimates, time at the bedside has decreased by almost half since the 1990s. A number of factors contribute to less time at the bedside, including operational constraints, duty hour requirements, a focus on patient throughput, and electronic health record workflows. This shift away from time with patients coincides with a decline in clinical skills and an increase in burnout, particularly among trainees.”
The next step is to minimize non-productive work.

UnitedHealth to invest $100M in diversifying healthcare workforce “The United Health Foundation, the philanthropic arm of UnitedHealth Group, will invest $100 million over the next decade to drive a more diverse healthcare workforce…
The investment is the single largest contribution ever made by United Health Foundation and will provide scholarships and support to 10,000 clinicians from underrepresented communities. The program will back 5,000 new students, with a focus on primary care, as well as support 5,000 clinics that want to progress careers in medicine, nursing, midwifery, mental health and other specialties.”

About health technology

 Wearables Market Sees First Decline at Beginning of 2022 as Demand Normalizes, According to IDC A good summary of the latest updates on the industry’s leading companies.

Today's News and Commentary

About Covid-19

MODERNA ANNOUNCES OMICRON-CONTAINING BIVALENT BOOSTER CANDIDATE MRNA-1273.214 DEMONSTRATES SUPERIOR ANTIBODY RESPONSE AGAINST OMICRON The headline is the story. Read the article for specifics of the vaccine’s performance. “Moderna is planning to submit the interim analysis and data to regulators for review in the coming weeks.”

 The Association Between COVID-19 Mortality And The County-Level Partisan Divide In The United States “Majority Republican counties experienced 72.9 additional deaths per 100,000 people relative to majority Democratic counties during the study period, and COVID-19 vaccine uptake explains approximately 10 percent of the difference. Our findings suggest that county-level voting behavior may act as a proxy for compliance with and support of public health measures that would protect residents from COVID-19.” 

White House shifts pandemic money to vaccines, cutting other programs “The Biden administration is shifting dwindling federal coronavirus funds toward securing another round of vaccines and treatments — rationing money and cutting back on other critical public health programs as Congress remains at odds over whether to spend more to battle the pandemic.
The U.S. government plans to redirect about $5 billion in existing funds so it can purchase any new, updated versions of the vaccines if they become available, according to an administration official, who spoke on the condition of anonymity to describe the deliberations. The government also intends to repurpose another $5 billion in previously authorized aid so it can secure access to therapeutics, including the pill Paxlovid, the aide said.”

About health insurance

 An Out-Of-Pocket Spending Cap Would Make Medicare More Affordable For Millions “More than 4.5 million Medicare enrollees (12 percent) will incur over $5,000 in cost-sharing expenditures next year. A $5,000 out-of-pocket spending cap for traditional Medicare would:

• Save beneficiaries an average of $5,500 a year, for those individuals whose annual out-of-pockets exceed $5,000.

• Decrease out-of-pocket costs for high spending enrollees by 51 percent; reduce supplementary plan spending by about 51 percent; and lower Medicaid spending by about 58 percent.

• Increase Medicare spending by $38.8 billion in 2023 relative to current law.”

About hospitals and healthcare systems

About pharma

 FTC Launches Inquiry Into Prescription Drug Middlemen Industry “The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.” 

Trends in Prescription Drug Launch Prices, 2008-2021 “From 2008 to 2021, launch prices for new drugs increased exponentially by 20% per year. In 2020-2021, 47% of new drugs were initially priced above $150 000 per year. Prices increased by 11% per year even after adjusting for estimated manufacturer discounts and changes in certain drug characteristics, such as more oncology and specialty drugs (eg, injectables, biologics) introduced in recent years. The study was limited to drugs sold by public companies…
The trend in prices for new drugs outpaces growth in prices for other health care services. Even after drugs are marketed, manufacturers routinely increase prices over time; in another analysis, net prices increased by 4.5% per year from 2007 to 2018. In response to the current trends, the US could stop allowing drug manufacturers to freely set prices and follow the example of other industrialized countries that negotiate drug prices at launch.”

About the public’s health

 Coffee Consumption May Mitigate the Risk for Acute Kidney Injury [AKI]: Results From the Atherosclerosis Risk in Communities Study “Higher coffee intake was associated with a lower risk of incident AKI and could present an opportunity for cardiorenal protection through diet. Further evaluation of the physiological mechanisms underlying the cardiorenal protective effects of coffee consumption is necessary.” 

About healthcare IT

 Oracle closes $28B deal to buy EHR giant Cerner “Software maker Oracle has closed its deal to acquire health IT company Cerner, effective Wednesday.
Austin-based Oracle finalized a stock tender offer on Monday with 69.2% of all Cerner shares being tendered to the acquiring company.
The all-cash deal values Cerner at $95 a share.”

Apple Watch's 'AFib History' feature ripens with new FDA clearance “The AFib History feature will be able to estimate how frequently an Apple Watch wearer shows signs of the irregular and often extremely rapid heartbeat. The software received 510(k) clearance from the FDA at the beginning of this month, allowing it to be used by people aged 22 and older who have already been diagnosed with afib…
Previous versions of the Apple Watch’s operating system have been able to track how many hours of sleep a wearer gets each night and their respiratory rate throughout. The OS 9 update builds on that, using the device’s accelerometer, heart rate sensor and built-in machine learning algorithms to detect when a user is in REM, core or deep sleep…
Another new addition to the software offers a module to Apple Watch and iPhone users to help track their medications.”

Interstate telehealth visits in jeopardy as pandemic licensure waivers expire “In March 2020, the Centers for Medicare and Medicaid Services (CMS) allowed individual states to waive within-state licensure requirements for Medicare beneficiaries obtaining telehealth services. Around this time, all 50 U.S. states and Washington, D.C., passed licensure waivers, which permitted patients to access telehealth visits with out-of-state providers. Now, the authors noted, this provision remains active in only 15 states.”

About healthcare personnel

 Why PAs aren't using the term 'physician associate' yet “The American Academy of Physician Assistants has officially changed its name to the American Academy of Physician Associates as part of a larger rebranding effort for the profession, but the association is not advising PAs to use the new term in a professional capacity yet…
News of the rebranding was met with opposition from several medical groups, including the American Medical Association and American Osteopathic Association. The groups argued that the new term would confuse patients, undermine the physician-led care team model and violate state laws regarding truth in advertising. 
While AAPA has officially rebranded, the organization is not recommending PAs use the term in clinical practice yet, per guidance from its legal counsel.”

About health technology

About healthcare finance

Today's News and Commentary

About Covid-19

 Advisers to the FDA back Novavax COVID vaccine “An FDA summary found the Novavax COVID vaccine had 90% efficacy in protecting people against mild, moderate and severe disease. The main study that the agency used to evaluate the Novavax vaccine's efficacy included about 30,000 patients in the U.S and Mexico. But data collection ended in late September 2021, months before omicron was detected in the U.S.
The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct the body's cells to make the protein that prompts an immune response. Both approaches have proved succesful against COVID-19.”

China offers Covid vaccine insurance to win over jab sceptics Fascinating idea: “Dozens of cities across the country have begun offering people aged 60 and older free insurance that pays out up to Rmb500,000 ($75,000) if they fall ill — or worse — because of Covid-19 vaccines. The packages also promise payouts to families if it can be proven that a loved one’s death was related to receiving a jab. In Beijing alone, about 60,000 seniors have signed up for the coverage since April.”

AB-2098 Physicians and surgeons: unprofessional conduct.(2021-2022) A Bill passed by the California legislature: “This bill would designate the dissemination or promotion of misinformation or disinformation related to the SARS-CoV-2 coronavirus, or “COVID-19,” as unprofessional conduct. The bill would require the board to consider specified factors prior to bringing a disciplinary action against a physician and surgeon.”

About health insurance

 Study: 87% of Medicare Advantage plans could lose one or more stars in 2023 ratings “More than 80% of Medicare Advantage plans are in danger of losing at least one star in one or more of their ratings for 2023, potentially imperiling millions in quality bonuses for plans, a new analysis finds…
The analysis from Press Ganey, which can conduct experience surveys from plan members, is based on preliminary 2022 data from 446 MA plans. It showed that 48% of MA plans are at risk of losing a star on the measure of getting needed prescription drugs, while 44% are at risk of losing one due to customer service and for care coordination…
Due to a final rule released in 2020, there are several CAHPS measures that have a greater emphasis on star ratings for 2023. 
Some of the measures that were weighted a two in 2022 will be a four next year, including:

• Customer service

• Getting needed prescription drugs

• Rating of drug plan

• Care coordination

• Rating of healthcare quality”

About hospitals and healthcare systems

 The top 10 nonprofit health systems by 2021 operating revenue  FYI

 HCA Healthcare Hit With More Price Inflation Allegations “The city of Brevard, North Carolina sued HCA Healthcare for allegedly inflating healthcare costs after it acquired Mission Health.
Nashville, Tennessee-based hospital giant HCA controls more than an 85% of the acute care market in the Asheville, North Carolina area and at least 70% of that market in the surrounding region, city officials claim in a complaint filed Friday in a North Carolina federal court. That leverage allegedly allowed HCA to force insurers and employers into anticompetitive contracts that included all-or-nothing provisions that required them to include all of their facilities in the health plan networks and steered patients away from competitors.”

About pharma

 California aims to slash insulin prices and challenge Big Pharma. Can it succeed? “[Governor] Newsom is asking state lawmakers to pump $100 million into an ambitious initiative to launch California’s generic drug label, CalRx, and begin producing insulin in the next few years, said Alex Stack, a Newsom spokesperson. The state is also working to identify other generic drugs it could bring to market, targeting those that are expensive or in short supply.” 

About the public’s health

 Menthol-flavored cigarettes may lead to increased smoking among teens, study finds “Researchers found that teen consumption of menthol cigarettes was associated with nearly three additional days of smoking over a 30-day period, a 38 percent higher risk of becoming a frequent smoker and an 8 percent higher nicotine dependency.
The Food and Drug Administration (FDA) in April proposed a ban on menthol cigarettes and flavored cigars and the agency is taking public comments on the matter through July 5 before making a final decision.” 

About healthcare IT

 Teladoc lawsuit claims company 'misled' investors “Teladoc is facing a lawsuit alleging the company misled investors regarding its business, operations and future prospects that will result in "significant losses and damages" for stakeholders.  
The lawsuit, filed June 6 on the behalf of parties that purchased Teladoc shares between October and April, accuses the company, along with CEO Jason Gorevic and CFO Mala Murthy, of downplaying competition in the mental health and chronic care business sectors, along with issuing "unrealistic" financial expectations for 2022.” 

About healthcare personnel

 Healthcare access looms as doctors' top concern, followed by substance abuse, racial disparities and gun control  “A strong majority, 85%, cited healthcare access as their most important concern, followed by substance/opioid abuse (66%), racial disparities (54%), gun control (53%) and climate change (51%), according to a new Medscape survey.
Nearly all the doctors surveyed say they support gun background checks, and a majority are in favor of abortion access with some restrictions by trimester.”

About health technology

 GE's contrast dye plant nears 100% capacity “Production of an X-ray imaging dye at a Shanghai plant will resume at normal speed this week after COVID-19-related shutdowns halted supply in May.
As hospitals postpone operations and ration the dye used for about 50 million annual CT scans and other imaging procedures, GE Healthcare expects the global supply of iodinated contrast media to progressively recover in the coming weeks, according to a June 2 press release from the company.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “As of June 1, 2022, the current 7-day moving average of daily new cases (100,684) decreased 8.5% compared with the previous 7-day moving average (110,081). A total of 84,315,762 COVID-19 cases have been reported in the United States as of June 1, 2022.”
To put the numbers in perspective, new COVID-19 cases have decreased for the first time since late March.

About health insurance

 DOJ joins whistleblower suit accusing Fresenius Medical Care of performing thousands of unnecessary vascular procedures “Two doctors allege in a lawsuit that the country's largest dialysis provider performed potentially thousands of unnecessary, invasive vascular procedures on late-stage kidney disease patients and fraudulently charged Medicare and Medicaid for these procedures.  
The Department of Justice has now joined the False Claims Act whistleblower lawsuit filed against dialysis giant Fresenius Medical Care, according to court documents filed in U.S. District Court in Brooklyn…
Nineteen states also are included in the lawsuit and potentially could join the case.”

HHS, CMS Extend American Rescue Plan Funding For HCBS Another Year “The US Department of Health and Human Services (HHS) and CMS announced that states will have another year to invest American Rescue Plan funds in home- and community-based services (HCBS).”

Justices side with Florida’s Medicaid program in payment dispute with accident victim “The Supreme Court on Monday ruled that state Medicaid programs can seek reimbursement from tort-settlement payments that are allocated for accident victims’ future medical care.
Justice Clarence Thomas wrote the opinion in Gallardo v. Marstiller. Justice Sonia Sotomayor (joined by Justice Stephen Breyer) dissented.
The issue in Gallardo was what to do when a state Medicaid program pays for injuries if the injured person later recovers a tort settlement from a third party. The case involved a Florida girl who suffered catastrophic injuries when she was hit by a pickup truck in 2008. By a 7-2 vote, the court upheld Florida’s effort to recover the portion of her tort settlement that reflects future medical expenses.”
This repayment is standard in commercial insurance.

Did the Comprehensive Care for Joint Replacement Program Make a Difference? “There is a paucity of literature on racial differences across a full total joint arthroplasty (TJA) “episode of care” and beyond. Given various incentives, the Comprehensive Care for Joint Replacement (CJR) program in the U.S. may have impacted preexisting racial differences across this care continuum. The purposes of the present study were (1) to assess trends in racial differences in care/outcome characteristics before, during, and after TJA surgery and (2) to assess if the CJR program coincided with reductions in these racial differences…
Racial differences persist among patients managed with TJA. The CJR program coincided with reductions in some racial differences, thus identifying bundle design as a potential novel strategy to target racial disparities.”
Read the detailed results for the affected metrics. It is clear that the findings are associations rather than proved causalities. 

About pharma

 Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer Numerous news outlets have cited this study as a major breakthrough in breast cancer treatment. “Among breast cancers without human epidermal growth factor receptor 2 (HER2) amplification, overexpression, or both, a large proportion express low levels of HER2 that may be targetable. Currently available HER2-directed therapies have been ineffective in patients with these ‘HER2-low’ cancers…”
While success markers such as disease progression, death and overall survival are impressive in terms of percentages, the actual improvements are in months not years. The medication comes from  AstraZeneca and Daiichi Sankyo.

Washington State Supreme Court Sides With Lilly Regarding Drug Warnings This ruling, if applied nationally, is a landmark in defining drug liability. “The ruling concluded a case against Lilly by an individual who alleged that he suffered a hemorrhage leading to a stroke less than two hours after taking the company’s erectile dysfunction drug Cialis (tadalafil), arguing that the company was negligent in not warning about the risk.
Lilly successfully argued that it had provided adequate warnings to the prescribing physician under the ‘learned intermediary doctrine,’ whereby the manufacturer of a prescription medical product must warn doctors, not patients, of a product’s risks and doctors must then convey the warnings to patients. The doctrine has been adopted in most states.”

BD to enter pharmacy automation market with $1.5B Parata purchase “BD is looking to dive into the growing market of automated hardware for dispensing medications in hospitals and retail pharmacies, and it’s paying $1.525 billion for the privilege.
The medtech company has signed up to buy Parata Systems from its corporate owner, the private equity firm Frazier Healthcare Partners, through an all-cash deal expected to close before next March…”

Tirzepatide Once Weekly for the Treatment of Obesity The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation.”

About the public’s health

 What Overturning Roe v Wade May Mean for Assisted Reproductive Technologies in the US An excellent review of this topic.

About healthcare IT

 The State of Ransomware in Healthcare 2022 Some highlights regarding healthcare organizations:
”66% hit by ransomware in the last year

61% attacks resulted in data encryption [industry-wide figure was 65%]

69%  increase in volume of cyber attacks, highest across all sectors

67% increase in complexity of cyber attacks, highest across all sectors

59% increase in impact of cyber attacks, second-highest across all sectors”
These figures highlight the profitability of these attack compared to “hacks” in other sectors.

 About health technology

 Caris Life Sciences to launch cancer blood test that spans a whopping 22,000 genes “The company has only presented early validation data on the Assure liquid biopsy assay, which made its debut at the annual meeting of the American Society of Clinical Oncology. But Caris says it scans for as many as 22,000 genes—using a combination of whole-exome and whole-transcriptome sequencing that sifts through the pieces of DNA and RNA found floating in the bloodstream.”

Today's News and Commentary

The 2022 Axios Harris Poll 100 reputation rankings The only pure-play healthcare organization in the top 25 is The Blue Cross Blue Shield Association (#13).

About Covid-19

Worldwide coronavirus cases cross 527.28 million, death toll at 6,703,868 “Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.”
For Reuter’s interactive global tracker, click: tmsnrt.rs/2FThSv7.

 Risk factors for SARS-CoV-2 infection and transmission in households with asthmatic and allergic children. A prospective surveillance study [Preprint] “In a multi-center SARS-CoV-2 surveillance study, conducted among asthmatic/allergic disease cohorts, participants with self-reported asthma were not at increased
risk for infection. However, self-reported food allergy and increasing BMI were associated with  decreased and increased risk for infection, respectively.”

Cross-reactive immunity against the SARS-CoV-2 Omicron variant is low in pediatric patients with prior COVID-19 or MIS-C “Overall, children and adolescents show some loss of cross-neutralization against all variants, with the most pronounced loss against Omicron. In contrast to SARS-CoV-2 infection, children vaccinated twice demonstrated higher titers against Alpha, Beta, Gamma, Delta and Omicron. These findings can influence transmission, re-infection and the clinical disease outcome from emerging SARS-CoV-2 variants and supports the need for vaccination in children.”

Pfizer says COVID-19 vaccine lawsuit is based on bogus patent “Pfizer and BioNTech told a Delaware federal court that Alnylam filed the lawsuit despite knowing that their vaccine did not infringe its patent on lipid nanoparticle (LNP) technology for transporting genetic material.
They argued the patent was invalid and unenforceable…
Cambridge, Massachusetts-based Alnylam separately sued Moderna Inc and Pfizer Inc in Delaware over their vaccines in March, seeking royalties for the LNP technology the shots use to deliver genetic material known as mRNA.”

J&J, BMS arthritis drugs lowered death risk among hospitalized COVID patients in federal study “The National Institutes of Health (NIH) led a large clinical trial on rheumatoid arthritis drugs in hospitalized COVID-19 patients. While researchers found that the treatments did not significantly shorten recovery time, they did improve clinical status and reduce deaths.”
Read the article for examples. The absolute percentage advantages were small.

Pfizer's Paxlovid reduces COVID risk in seniors regardless of vaccine status -study “Pfizer Inc's antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus.
The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel's largest healthcare provider.”

About health insurance

 Traditional Medicare Spending Fell Almost 6% in 2020 as Service Use Declined Early in the COVID-19 Pandemic From the KFF:
Highlights:

1. Total spending on Part A and Part B services for traditional Medicare beneficiaries was $348.0 billion in 2020, a decrease of 5.8% ($21.4 billion) from 2019.

2. Spending per traditional Medicare beneficiary for Part A and Part B services fell 3.6%, or $402, to $10,739 per person in 2020, compared to $11,142 per person in 2019.

3. The decline in traditional Medicare spending reflects decreases in spending for most types of services, ranging from 0.1% less for durable medical equipment to 13.1% less for procedures, compared to 2019. Only spending on skilled nursing facilities, Part B drugs, and hospice increased in 2020

4. Use of nearly all types of services by traditional Medicare beneficiaries was lower in 2020 compared to 2019. Only three types of services had increases across all measures of utilization: hospice, dialysis, and Part B drugs. Skilled nursing facilities had lower use but higher spending”

A SUMMARY OF THE 2022 ANNUAL REPORTS from the Social Security and Medicare Boards of Trustees
Based on our best estimates, the 2022 reports determine:

• The Old-Age and Survivors Insurance (OASI) Trust Fund, which pays retirement and survivors benefits, will be able to pay scheduled benefits on a timely basis until 2034, one year later than reported last year. At that time, the fund's reserves will become depleted and continuing tax income will be sufficient to pay 77 percent of scheduled benefits. 

• The Disability Insurance (DI) Trust Fund, which pays disability benefits, is no longer projected to be depleted within the 75-year projection period. By comparison, last year's report projected that it would be able to pay scheduled benefits only until 2057. 

• The OASI and DI funds are separate entities under law. The report also presents information that combines the reserves of these two funds in order to illustrate the actuarial status of the Social Security program as a whole. The hypothetical combined OASI and DI funds would be able to pay scheduled benefits on a timely basis until 2035, one year later than reported last year. At that time, the combined funds' reserves will become depleted and continuing tax income will be sufficient to pay 80 percent of scheduled benefits.

• The Hospital Insurance (HI) Trust Fund, or Medicare Part A, which helps pay for services such as inpatient hospital care, will be able to pay scheduled benefits until 2028, two years later than reported last year. At that time, the fund's reserves will become depleted and continuing total program income will be sufficient to pay 90 percent of total scheduled benefits.

• The Supplemental Medical Insurance (SMI) Trust Fund is adequately financed into the indefinite future because current law provides financing from general revenues and beneficiary premiums each year to meet the next year's expected costs. Due to these funding provisions and the rapid growth of its costs, SMI will place steadily increasing demands on both taxpayers and beneficiaries. 

• For the sixth consecutive year, the Trustees are issuing a determination of projected excess general revenue Medicare funding, as is required by law whenever annual tax and premium revenues of the combined Medicare funds will be below 55 percent of projected combined annual outlays within the next 7 fiscal years. Under the law, two such consecutive determinations of projected excess general revenue consitute a ‘Medicare funding warning.’ Under current law and the Trustees' projections, such determinations and warnings will recur every year through the 75-year projection period.”
Look at Table 6 for some interesting financial dates.

About pharma

 Bristol Myers strikes up Roche rivalry with $4.1B Turning Point buy “Eyeing a rivalry with Roche and a new cancer asset slated to hit the markets next year, Bristol Myers Squibb is picking up Turning Point Therapeutics in a $4.1 billion acquisition.
BMS will gain access to repotrectinib, a midstage candidate in testing for first-line lung cancer as a potential competitor to Roche’s Rozlytrek. The Big Pharma landed Turning Point for $76 per share, with both companies’ boards approving the transaction that is slated to close in the third quarter. 

About the public’s health

 Trends in Annual Sales and Pack Price of Cigarettes in the US, 2015-2021 “From February 1, 2015, to December 26, 2021, the annual number of cigarette packs sold decreased by 27.2%, from 12.5 billion packs to 9.1 billion packs... During this period, dollar sales decreased overall by 6.0%, from $69.8 billion to $65.6 billion…, while prices increased by 29.5%, from $5.57 to $7.22 per pack (AAPC, 4.3%; 95% CI, 4.1% to 4.6%). Menthol cigarettes accounted for 33.0% of total sales in 2021; there was no significant change in this percentage from 2015 to 2021.
From January 26, 2020, to December 26, 2021, annual cigarette pack sales decreased by 7.6% (9.8 billion to 9.1 billion packs); dollar sales decreased by 1.4% ($66.5 billion to $65.6 billion), while prices increased by 6.8% ($6.76 to $7.22 per pack). Menthol share remained stable at 33.0%.”

Bariatric Surgery and Cancer Risk [Editorial] “In summary, bariatric surgery appears to be associated with a decreased risk of incident cancer and cancer mortality. More work needs to be done through large, well-designed studies that would include data on cancer screening, data from tumor registries, more detailed individual patient data, and investigations of the basic mechanisms of effect. If this association is further validated, it would extend the benefits of bariatric surgery to another important area of long-term health and prevention. This additional information could then further guide for whom bariatric surgery is most beneficial.” 

Gen Z wants health providers to ask about food, housing, safety and more “More than 1,000 youth aged 14 to 24 answered five open-ended questions via text message in March 2021. Nearly 39% of respondents came from families whose income levels qualified them for free or reduced-price school lunch under national criteria.
The poll asked about housing, food, education, safety and discrimination – all factors that can affect a person’s health in the short and long term, and their ability to seek care and keep up with treatments. 
In all, 81% of youth said providers should ask about such factors. Nearly a third said that embarrassment might keep them from seeking help for such issues if they were experiencing them. 
In addition, a quarter said they would want providers to offer resources for people with social needs, and a nearly equal percentage said providers should offer information about resources that could assist people with such needs.”

Genetic data indicate at least two separate monkeypox outbreaks underway, suggesting wider spread “The Centers for Disease Control and Prevention said Friday that new genetic sequencing data indicate there are at least two distinct monkeypox outbreaks underway outside Africa — a surprise finding that one official said suggests international spread is wider, and has been occurring for longer than has been previously realized.
Three of 10 viruses the CDC has sequenced from recent U.S. monkeypox cases — two from 2021 and eight from 2022 — are different from the viruses that have been sequenced by several countries involved in the large outbreak that is spreading in and from Europe. That outbreak is currently being driven by infections in gay, bisexual, and other men who have sex with men.” 

About health technology

 Abbott plans new wearable sensor for catching diabetic ketoacidosis “Abbott’s proposed new biowearable would continuously track both glucose and ketone levels in a single sensor, helping users catch rising ketones as early as possible, well before it develops into diabetic ketoacidosis.
The sensor—still in development—will be the same size as the FreeStyle Libre 3 device, which boasts a small and thin form factor measuring in with a width of just two stacked pennies.”