29 best-managed healthcare companies: “Healthcare companies hold 29 spots in the top 250 best-managed companies in 2020, according to a ranking by the Drucker Institute published in The Wall Street Journal.
Customer satisfaction, employee engagement and development, innovation, social responsibility, and financial strength are five areas used to measure the organizations' performance. Companies received a score from zero to 100.”
Overall 9th and highest rated healthcare company is Johnson & Johnson.
Lawsuit claims HHS sunset rule is a 'ticking timebomb' for agency: “A new lawsuit led by several health groups seeks to strike down a last-minute rule approved under the Trump administration that will create ‘incalculable costs and chaos’ for the Department of Health and Human Services (HHS).
The lawsuit, filed… in the U.S. District Court for the Northern District of California, concerns a controversial rule that requires HHS to review and approve any regulations 10 years or older to ensure they are up to date. Any rule that does not get approved or reviewed will expire in 2026.”
About Covid-19
Seven European countries clamp down on AstraZeneca COVID-19 vaccine as safety worries threaten rollout: “AstraZeneca’s COVID-19 vaccine rollout has gotten off to a rocky start in Europe—to put it mildly. First, a supply shortfall triggered a public back-and-forth between executives and government officials. Then several countries expressed doubts about how well the vaccine works in people over 65. Now seven countries are raising safety concerns.
Denmark, Norway, Austria, Estonia, Latvia, Lithuania and Luxembourg have halted some or all of their AstraZeneca COVID-19 vaccinations over fears of blood clots, France24 reports.”
In related articles: Thailand suspends AstraZeneca vaccine because of ‘adverse symptoms’ and
Britons told to keep getting vaccines after some countries suspend AstraZeneca shots
The U.S. bought enough coronavirus vaccines for three times its adult population: “They include:
100 million doses from Johnson & Johnson
300 million doses from Pfizer
300 million doses from Moderna
300 million doses from AstraZeneca
100 million doses from Novovax
100 million doses from Sanofi”
Only the first three have been approved in the US.
Former President Trump ordered doses in advance of approval from all these companies.
Will we export excess vaccines or hold them in a stockpile if we find we need to administer booster shots?
Vaccine efficacy probable against COVID-19 variants: “…studies show that what appears to be magnitudes of difference in NAb [neutralization antibody] activity may not necessarily correlate with clinical immunity. As variant strains emerge, we will need to reevaluate vaccine efficacy by testing the inhibition of viral infection in vivo rather than by quantifying the antibodies produced after in vitro exposure. Reliable proof of immunity through vaccination may only come through reinfection challenge experiments or through longitudinal studies of postvaccination subjects.”
Study Says Naturally-Produced COVID-19 Antibodies and Single Dose of Pfizer/BioNTech Vaccine May Be Sufficient: “A single dose of Pfizer/BioNTech’s vaccine after prior COVID-19 infection may generate the same or higher levels of antibodies as having had two doses of the vaccine, according to a small study led by researchers from NYU Grossman School of Medicine’s Vaccine Center.
The study also suggests that the immune responses in most patients previously infected with the virus did not improve further after a second dose of vaccine.”
‘An accelerated cauldron of evolution’: Covid-19 patients with cancer, HIV, may play a role in emergence of variants: “Some hospitalized patients with weakened immune systems were shown to have mutating viruses months before the variants were discovered in the outside world.”
Novavax coronavirus vaccine completely prevents severe illness, but was less effective at preventing infections by variants: “In its final analysis, which has not yet been peer-reviewed or published, the company said that its vaccine was 96 percent effective against mild, moderate and severe cases of covid-19 caused by the original strain. That dropped, modestly, to 86 percent against the B.1.1.7 variant first detected in the United Kingdom. In South Africa, where a variant called B.1.351 has become dominant, the vaccine was 55 percent effective against any cases of covid-19 among participants who were not infected with HIV.
But it was 100 percent effective against severe disease, including against the variants.”
Activists, drug groups in waiver war over COVID-19 shot patents: “A World Trade Organization (WTO) council is discussing a proposal by India and South Africa that COVID-19 vaccine and other medical patents be suspended to speed up technology transfers to manufacturers with spare production capacity.”
It is unclear why debate would need to take place when the compulsory license procedure applies to vaccine manufacture. (See the Technology chapter in the book.)
Eli Lilly COVID-19 antibody combo aces study, cutting hospitalizations and deaths by a whopping 87%: “Eli Lilly’s COVID-19 antibody combo already boasts an FDA authorization for patients at a high risk of developing severe disease, but now the company has even stronger data backing the duo.
In trial data released Wednesday, the company said its bamlanivimab-etesevimab duo slashed the risk of hospitalization and death by a whopping 87% versus placebo. Investigators tested a combination of 700 mg of bamlanivimab and 1400 mg of etesevimab in a trial comprising 769 patients total…
Patients over 65, or those under 65 but who are overweight or have multiple health problems, qualify as high-risk for treatment with the drug.”
What claims from 150,000 Cigna members reveal about common diagnoses post-COVID-19:
”Here are the five most common long-term, post-COVID-19 complications Cigna found:
1. Nervous system (headache/migraine, stroke and seizures)
2. Chronic respiratory conditions
3. Heart disease
4. Mental health disorders
5. Renal/urinary conditions”
Majority Approves Of Biden's Handling Of Pandemic, NPR/PBS NewsHour/Marist Poll Finds: “Sixty-two percent of Americans approve of how Biden is handling the pandemic.”
About the public’s health
Biden directing $2.5B to address mental health and addiction crisis: “The funds will be broken down into two components by the Substance Abuse and Mental Health Services Administration.
$1.65 billion will go toward the Substance Abuse Prevention and Treatment Block Grant, which gives the receiving states and territories money to improve already-existing treatment infrastructure and create or better prevention and treatment programs.
$825 million will be allocated through a Community Mental Health Services Block Grant program, which will be used by the states to deal specifically with mental health treatment services.”
Life expectancy in adulthood is falling for those without a BA degree, but as educational gaps have widened, racial gaps have narrowed: “Our main aim here is to document the patterns… that the fall in period life expectancy between 25 and 75 in the US population is confined to those without a 4-y college degree, and that this is true for men and women and for Black and White people. The widening educational differences have meant that education is now a sharper differentiator of expected years of life between 25 and 75 than is race [emphasis added], a reversal of the situation in 1990.”
Coalition eyes 100-day target for new vaccines against disease epidemics: “An international coalition set up to prepare for future infectious disease threats set out what it called its ‘moonshot’ plan on Wednesday to ensure new vaccines against emerging disease epidemics are developed within 100 days.
Launching a $3.5 billion five-year strategy to tackle future pandemic risks, the Coalition for Epidemic Preparedness Innovations (CEPI) said more needs to be done urgently to mitigate the threat posed by new COVID-19 variants, and to prepare for new infectious diseases…
CEPI, which was created in 2017 with initial donor funding from Germany, Japan and Norway and from the Bill & Melinda Gates Foundation and the Wellcome Trust global health charity, has played a key role in funding early development of a range of candidate vaccines against COVID-19.”
About pharma
Senate OKs Drug Exclusivity Change To Boost Generics: “The Senate has easily approved two bipartisan bills meant to lower prescription drug prices by boosting generics and biosimilars, including one proposal to tighten eligibility for the new drug exclusivity period during which innovators can avoid competition. The Ensuring Innovation Act would codify the U. S. Food and Drug Administration's efforts to award exclusivity based on the ‘active moiety’ rather than the ‘active ingredient,’ limiting when drug companies can get new exclusivity periods related to existing drugs and avoid competition from generic versions. It passed the Senate on Wednesday by unanimous consent, meaning no senator objected to its approval…”
If this bill becomes law it could be a huge “game changer” for pharma.
FDA's pandemic-related drug inspection backlog could drag on, GAO warns: “According to the US Government Accountability Office (GAO), the COVID-19 pandemic has forced the FDA to postpone more than 1000 of its planned fiscal year 2020 surveillance inspections, and the agency will ‘likely face a backlog of inspections in future years.’ The GAO report, which was recently submitted to a US House subcommittee, indicates that in addition to affecting inspections on the domestic front, pandemic-related travel restrictions and safety concerns have also hampered the FDA's ability to ensure the safety of imported medicines.”
Dr. Reddy's pulls hundreds of thousands of bottles of Lipitor generic over impurity fears: “Dr. Reddy’s Princeton, New Jersey, outfit is pulling hundreds of thousands of bottles of the cholesterol drug atorvastatin calcium in the U.S. due to impurities that turned up in the product. The company is also recalling one batch of the hormone progesterone after stability testing revealed subpar dissolution.”
Antibiotic/Antimicrobial Resistance: “Each year in the U.S., at least 2.8 million people get an antibiotic-resistant infection, and more than 35,000 people die.” This CDC update lays out the agency’s approach to addressing this problem.
Drug Price Spotlight: WOUND DRESSING PRODUCTS: From Optum: “In the U.S., chronic wounds affect an estimated 6.5 million people, resulting in annual treatment costs of up to $25 billion…
Notably, high-cost prescription wound dressings have not demonstrated consistent clinical benefit compared to those with similar active ingredients available in low-cost prescription or over-the-counter (OTC) form.
Recently, manufacturers have launched new brand-name prescription wound dressings that include similar combinations of ingredients as OTC and lower-cost generic products. Yet, they are priced far higher than the alternatives — up to 125 times more [SIL-K PAD® Silicone pads].” [All emphases in original].
FDA grants fast track designation to stem cell therapy for type 1 diabetes: “The FDA granted fast track designation to VX-880, a human stem cell-derived therapy for patients with type 1 diabetes, according to the agent’s manufacturer.
VX-880 (Vertex Pharmaceuticals) is a first-in-class, allogeneic, fully differentiated islet cell therapy designed to regulate glucose levels by restoring a patient’s pancreatic islet cell function, including insulin production.”
Takeda to Purchase Maverick for $525 Million to Boost T-Cell Therapy Pipeline: “Takeda Pharmaceutical is expanding its immune-oncology portfolio by acquiring Brisbane, Calif.-based Maverick Therapeutics for $525 million.
The Japanese drugmaker will gain access to Maverick’s COBRA T-cell engaging platform and development pipeline. T‐cell engager technology is designed to treat cancers by connecting patients’ T-cells to cancer cells.”
5 dated drugs that are getting new indications: Interesting look at these “old” medications. The article highlights the fact that technology assessment is a continuing process of reevaluation.
About healthcare IT
Mahana Therapeutics Earns CE Mark for Digital Irritable Bowel Syndrome Therapeutic:What is interesting about this article (other than the app itself) is the FDA approval of a digital treatment.
Incremental Benefits of Machine Learning—When Do We Need a Better Mousetrap?: A thoughtful review of machine learning, how it can help with analysis and where it falls short of promises. For example, for “typical clinical prediction tasks, wherein predictions are based on a modest number of clinical variables, ML algorithms are on par with logistic regression.”
However, “in medical image processing, prediction models have reached levels of performance unimaginable only a decade ago, largely because of the success and popularization of deep convolutional neural networks.”
In a related article: Association of Clinician Diagnostic Performance With Machine Learning[ML]–Based Decision Support Systems: A Systematic Review: “This systematic review found only sparse evidence that the use of ML-based CDSSs [Clinical Decision Support Systems] is associated with improved clinician diagnostic performance. Most studies had a low number of participants, were at high or unclear risk of bias, and showed little or no consideration for human factors. Caution should be exercised when estimating the current potential of ML to improve human diagnostic performance, and more comprehensive evaluation should be conducted before deploying ML-based CDSSs in clinical settings. The results highlight the importance of considering supported human decisions as end points rather than merely the stand-alone CDSSs outputs.”
Utah COVID-19 testing company stored data on public server, exposing 52,000 patients' info: “Premier Diagnostics, a Lehi, Utah-based diagnostic testing company, left about 52,000 patients' data exposed last month after storing the information on a publicly accessible server…”
American Medical Collection Agency reaches 40-state settlement for data breach that exposed 21 million patients' info: “American Medical Collection Agency on March 11 reached a settlement with 40 states and Washington D.C., to settle a complaint following a 2019 cyberattack that exposed 21 million Americans' personal information, including Social Security numbers, diagnoses and credit card information.
The Elmsford, N.Y.-based company specializes in small-balance medical-debt collection and offers services mostly for laboratories and medical testing facilities.”
Hackers Breach Thousands of Security Cameras, Exposing Tesla, Jails, Hospitals: “A group of hackers say they breached a massive trove of security-camera data collected by Silicon Valley startup Verkada Inc., gaining access to live feeds of 150,000 surveillance cameras inside hospitals, companies, police departments, prisons and schools.”
About health technology
FDA Clears Promaxo’s Magnetic Resonance Imaging Platform for Office Settings: “The FDA has granted Promaxo 510(k) marketing clearance for its office-based magnetic resonance imaging (MRI) system, the Promaxo MRI.
The system is now cleared for use in hospitals and physicians’ offices for guiding prostate interventions using its scanner. It is intended for use by urologists and interventional/urologic radiologists for surgical localization of prostatic lesions in the office or outpatient surgical settings.
The device is easy to install in an office because it does not need special shielding or facility upgrades, and it does not require the use of endorectal coils in patients during MRI scans.”
While only approved for limited indications, this device has huge potential for other in-office uses.
About health insurance
Biden Administration Pauses Key Value-Based Reimbursement Models: “The Biden administration has paused several prominent value-based reimbursement models run by the CMS Innovation Center (CMMI) to review model details, according to several updates provided on model webpages.
Among the value-based reimbursement models impacted are the Geographic Direct Contracting Model, Primary Care First Model’s Seriously Ill Population option, and the Kidney Care Choices Model—three models approved by the Trump administration…
A separate update was also recently provided for the CMS' largest value-based reimbursement model, the Medicare Shared Savings Program, pushing back the application process timeline for accountable care organizations (ACOs) applying to participate starting Jan. 1, 2022.”
Ohio sues Centene, claims misrepresented pharmacy expenses cost Medicaid millions: “Ohio Attorney General Dave Yost filed a lawsuit against Centene March 11, claiming the company's subsidiary, Buckeye Health Plan, used a web of subcontractors to misrepresent pharmacy costs, which led to millions of dollars in overpayments by the state's Medicaid department.”
CMS Announces Final participants in Emergency Triage, Treat, and Transport (ET3) Model, Furthers Commitment to Ensure Beneficiaries Have Access to Quality Care and Treatment: This model extends the opportunity for payment to certain ambulance services treating patients on site, not just when they are transported to a hospital.
Supreme Court cancels arguments in Medicaid work requirement case: “The Supreme Court on Thursday called off upcoming arguments over a Trump-era plan to impose work requirements on Medicaid recipients after the Biden administration said it was considering scrapping the policy.
Arguments had been slated for March 29, but were removed from the court calendar after the Biden administration asked the justices last month to put the case on hold while it undertook a policy review.”
In a related article: HHS data highlights negative effects of work requirements
Providers Blast Medicare Spending Cuts in COVID Relief Package: “Implementation of the American Rescue Plan will trigger automatic spending cuts as a deficit control measure, resulting in $36 billion in Medicare spending cuts in fiscal year 2020 alone…
The American Hospital Association (AHA) is predicting hospitals alone to be down by up to $122 billion in 2021. That is on top of the estimated $323 billion in losses the previous year.”
In a related story: House to advance bill preventing automatic Medicare cuts: “House Democrats are planning to advance a bill that would stop automatic spending cuts to programs such as Medicare next week, a necessary step after President Biden signed the $1.9 trillion COVID-19 relief package into law Thursday.”
Government will fully cover laid-off workers’ COBRA premiums through September: “The government will pay for laid-off workers to maintain their employer-sponsored health insurance through September, thanks to a provision in the $1.9 trillion stimulus package signed into law on Thursday by President Joe Biden.
As part of the relief bill, the government will subsidize COBRA premiums for former workers of a company until the fall.”
Pharmacy owner and accountant indicted in $134M health care fraud scheme: “4M Pharmaceuticals allegedly functioned as an outbound telemarketing call center that solicited Medicare, Medicaid and commercial insurance patients nationwide… The indictment alleges call center employees offered patients medically unnecessary diabetic supplies and topical creams although many refused the solicitations. However, 4M Pharmaceuticals and pharmacies allegedly billed the patient’s insurance plan anyway. In some cases, 4M pharmacies billed for prescriptions dispensed after a patient’s death, according to the allegations.
The scheme also allegedly targeted doctors. The charges allege 4M Pharmaceuticals sent fax requests for prescriptions that patients often did not authorize. In several cases, the company billed patients for prescription drugs without a valid prescription, according to the allegations. 4M pharmacies also allegedly sent prescription requests to doctors for dead patients.”
2 Texas Doctors Agree To Plead Guilty In Tricare Fraud Case: “Two doctors charged in an alleged $100 million Tricare fraud scheme agreed to plead guilty to charges of misusing a health identifier to write prescriptions and agreed to pay a total of $851,000 in restitution to the Defense Health Agency…”
According to another article: “The alleged fraud occurred between 2014 and 2016, and involved kickbacks and a conspiracy to sell soldiers pricey pain and scar creams that were unnecessary, while the military health plan paid for the ruse. The government said pharmacies paid marketers for attracting fraudulent prescriptions to their business while defendants paid kickbacks to doctors in order to refer more prescriptions.”
About hospitals and health systems
Trinity Health posts $2.7B in net income for 2nd half of its fiscal year: “Trinity Health reported earnings of $2.7 billion for the second half of its fiscal year that ended Dec. 31, 2020, a major jump over the $805 million it generated in the same period the year before.
Trinity posted its earnings Friday for the second half of its 2021 fiscal year that started in July 2020. The earnings come amid declines in patient service revenue due to the COVID-19 pandemic. Trinity Health is the latest hospital system to post positive earnings despite patient revenue declines.”
4 recent health system credit rating downgrades: FYI. However, in a related article: Debt default risk for hospitals drops from 2020 high: “In 2020, the median default odds jumped to 8.1 percent. However, as of March 8, the probability of default rate fell to 0.9 percent.”