Today's News and Commentary

About Covid-19

Johnson & Johnson vaccine use should resume with a warning about risk of rare blood clots, CDC advisers recommend

CDC recommends pregnant women get coronavirus vaccine: “At a White House briefing on the coronavirus Friday, CDC Director Rochelle Walensky said that vaccination surveillance systems showed ‘no safety concerns’ for more than 35,000 women in their third trimester or for their babies.”
The recommendation is also important because of evidence of increased infection severity during pregnancy.

Pfizer COVID-19 shot effective for people with chronic diseases- Israel study: “The vaccine was 80% effective against symptomatic infection for people with heart or chronic kidney diseases, 86% for people with type 2 diabetes, 75% for cerebrovascular disease, and 84% for people suffering from immunodeficiency, according to the Clalit Research Institue study.”

B.1.526 SARS-CoV-2 variants identified in New York City are neutralized by vaccine-elicited and therapeutic monoclonal antibodies: “The findings suggest that current vaccines and therapeutic monoclonal antibodies will remain protective against the B.1.526 variants. The findings further support the value of wide-spread vaccination.”

COVID-19 hospitalizations tumble among U.S. senior citizens: “COVID-19 hospitalizations among older Americans have plunged 80 percent since the start of the year, dramatic proof the vaccination campaign is working. Now the trick is to get more of the nation’s younger people to roll up their sleeves.
The drop-off in severe cases among people 65 and older is so dramatic that the hospitalization rate among this highly vaccinated group is now down to around the level of the next-youngest category, Americans 50 to 64.”

How long does protection from COVID-19 vaccines last?: Nothing new, but it is a good summary. The short answers:
”Experts don’t know yet because they’re still studying vaccinated people to see when protection might wear off. How well the vaccines work against emerging variants will also determine if, when and how often additional shots might be needed…
So far, Pfizer’s ongoing trial indicates the company’s two-dose vaccine remains highly effective for at least six months, and likely longer. People who got Moderna’s vaccine also still had notable levels of virus-fighting antibodies six months after the second required shot. 
Antibodies also don’t tell the whole story. To fight off intruders like viruses, our immune systems also have another line of defense called B and T cells, some of which can hang around long after antibody levels dwindle. If they encounter the same virus in the future, those battle-tested cells could potentially spring into action more quickly.”

Shift to virtual care during COVID-19 saved 1.7M gallons of fuel, 15K tons of CO2 emissions: CommonSpirit Health: One consistent benefit of the pandemic is the positive environmental effect of business slowdowns. This article is the first one I have seen that was specific to a healthcare system.

Low-dose Administration of MERS DNA Vaccine Candidate Induces Potent Immunity and Protects From Virus Challenge in Preclinical Models: Recall that MERS is a coronavirus illness. This new technique uses low dose, intradermal (in the skin) injections to confer immunity. If the animal model success is duplicated in humans, it could be used for prevention of other coronavirus infections (like SARS-CoV-2).

Johnson & Johnson said blood clots have been reported with all Covid-19 vaccines. The author of the study they cited says they're wrong: “When news broke that Johnson & Johnson's COVID-19 vaccine might be linked to rare, potentially fatal blood clots, the company responded by pointing to a study it said had shown there were reports of clots with Pfizer and Moderna's vaccines as well, reported CNN.
However, the study's leader author Eun-Ju Lee disputes the claim, saying ‘we didn't find anyone with blood clots’ with Moderna and Pfizer's vaccines, ‘we didn't find any of those scary things that are happening with Johnson & Johnson.’”

About pharma

Pelosi pushes for drug pricing measure amid uncertainty from White House: “House Democrats on Thursday reintroduced their signature legislation to lower drug prices, known as H.R. 3, and Pelosi pointedly noted in a statement that including it in Biden's proposal is important for Democratic lawmakers. The measure would allow the secretary of Health and Human Services to negotiate lower drug prices, a long-held Democratic goal.”

Biogen's sales fall 24% in Q1 as aducanumab decision looms large: As biosimilars have eaten into Biogen’s profit, the company is looking to FDA approval for its Alzheimer’s drug.

About health insurance

CMS gives massive $80M increase to navigators for 2022 coverage plan year: “The Biden administration will give Affordable Care Act (ACA) navigators $80 million for the 2022 plan year, reversing slides in funding that occurred during the Trump administration.” And in a related article:
How Agents Influence Medicare Beneficiaries’ Plan Choices: This Commonwealth Fund research found that: “Nearly all (96%) Medicare Advantage and Part D plans contract with agents, who are not required to represent all available plans. An analysis across five markets of three large, online broker plan selection tools found that, on average, each tool includes less than half (43.3%) of Medicare Advantage plans and less than two-thirds (64.7%) of Part D plans. In the analysis of online searches, more than one-third (36%) of results from the first page led to agents’ or health insurers’ websites.
Conclusion: Agents play an important role for beneficiaries; however, the existing approach affects information about coverage options and may not optimally serve beneficiaries’ needs by limiting their choice.”

How UnitedHealth plans to make Optum a $100B business: “UnitedHealth Group bought its first medical practice 15 years ago and now aims to make providing healthcare its next $100 billion business, according to Insider
UnitedHealth Group's OptumCare business comprises 56,000 physicians and 1,600 clinics, and it's on track to add at least 4,000 affiliated, contracted and employed physicians this year. OptumCare is the bulk of a business unit called OptumHealth, and executives are aiming to grow it from a $40 billion business to a $100 billion one by 2028, according to the report. 
OptumHealth CEO Wyatt Decker, MD, told Insider that moving physicians into ‘value-based’ arrangements and away from fee-for-service care is one way the business will grow revenue. He said physicians will be paid to keep patients healthy rather than billing health plans for every patient visit or test.”

Ill. Physician Gets 1 Year For Faking $1M Worth Of Tests - “A physician was sentenced to a year and a day in prison in Illinois federal court Thursday for defrauding Blue Cross Blue Shield of Illinois and Medicare of nearly $1 million by submitting thousands of claims for tests his patients never received. U. S. District Judge Ronald Guzman handed down the sentence to Pranav Patel about four months after the physician, who owned Palos Medical Care SC, admitted he submitted more than 10,000 false claims to BCBS and the federal government between 2008 and 2013 for diagnostic tests he never actually provided to patients.”

About the public’s health

Oxford Malaria vaccine proves highly effective in Burkina Faso trial: “The vaccine, developed by scientists at the Jenner Institute of Oxford University, showed up to 77% efficacy in a trial of 450 children in Burkina Faso over 12 months.
The hunt for a malaria vaccine has been going on the best part of a century. One, the Mosquirix vaccine developed by GlaxoSmithKline, has been through lengthy clinical trials but is only partially effective, preventing 39% of malaria cases and 29% of severe malaria cases among small children in Africa over four years. It is being piloted by the World Health Organization in parts of Kenya, Ghana and Malawi.
The Oxford vaccine is the first to meet the WHO goal of 75% efficacy against the mosquito-borne parasite disease. Larger trials are now beginning, involving 4,800 children in four countries.”

Texting option weighed for upcoming ’988′ suicide hotline: “Recognizing that many Americans rely on texting, U.S. regulators are weighing whether to require that phone companies allow people to text a suicide hotline. 
The Federal Communications Commission last summer voted to require a new “988” number for people to call to reach a suicide-prevention hotline. Phone companies have until July 2022 to implement it.
Once it’s in place, people will be able to dial 988 to seek help, similar to how 911 is used for emergencies. Currently, the National Suicide Prevention Lifeline uses a 10-digit number, 800-273-TALK (8255), which routes calls to about 170 crisis centers.”
Are texts going to be answered quicker than calls? Are responses also by text? Has texting been more effective? The only clear advantage is for “those who are deaf, hard of hearing or have speech disabilities.” Is texting more convenient when you need a phone anyway to text?

About healthcare systems

Kaiser Reaches $11.5M Settlement To Wrap Up Race Bias Suit: “Kaiser Permanente will pay $11. 5 million to resolve a lawsuit accusing the health care giant of underpromoting and underpaying a class of more than 2,000 Black workers, according to Thursday filings in California state court. The settlement, filed alongside a same-day complaint in San Francisco Superior Court, would cover claims from approximately 2,225 California-based African American or Black employees who worked in administrative support or consulting services at Kaiser or its related entities between January 2015 and March 2021.”



Today's News and Commentary

About Covid-19

Scientists warn of challenges to find antiviral pill to treat Covid: A good review of this issue.

Johnson & Johnson trial shows vaccine effective, even against variants: “Johnson & Johnson's single-shot coronavirus vaccine protected against symptomatic and asymptomatic infection, and prevented hospitalization and death in all participants 28 days after vaccination, according to new clinical trial results published Wednesday.
The vaccine was 67 percent effective on average against moderate to severe–critical COVID-19 at least 14 days after administration, and 66 percent effective at 28 days after vaccination, according to data published in the New England Journal of Medicine
The vaccine was about 77 percent effective against severe/critical COVID-19 at 14 days after administration, and 85 percent after 28 days.”

European countries to resume J&J COVID vaccine deliveries: “European countries prepared on Wednesday to resume deliveries of Johnson & Johnson’s COVID-19 vaccine and speed up the rollout after Europe’s drug regulator backed the shot.”

COVID vaccines and kids: five questions as trials begin: A good review of this topic from Nature.

Biden presses employers to provide paid time off for vaccine shots, recovery: “‘I’m calling on every employer large and small in every state to give employees the time off they need, with pay, to get vaccinated,’ Biden said. ‘No working American should lose a single dollar from their paycheck because they chose to fulfill their patriotic duty of getting vaccinated.’”

U.S. sees significant drop in vaccinations over past week: “About 3 million Americans are getting vaccinated daily, an 11 percent decrease in the seven-day average of daily shots administered over the past week. The unprecedented drop is rivaled only by a brief falloff that occurred in February, when winter storms forced the closure of vaccination sites and delayed shipments nationwide.”

Burned out by the pandemic, 3 in 10 health-care workers consider leaving the profession: The headline is the story.

About hospitals and healthcare systems

HCA reports $1.4B in profit in Q1 thanks to higher patient acuity, stable payer mix: “HCA Healthcare posted nearly $14 billion in revenue and $1.4 billion in profit for the first quarter of the year as the hospital chain continues to face lingering volume declines from the pandemic.
HCA’s earnings report, released Thursday, shows revenues are up in the first quarter, generating $13.9 billion compared to the $12.8 billion in the first quarter of 2020. The system’s $1.4 billion in profit was up compared to the $581 million it generated in the same period in 2020.”

Hospital adjusted expenses per inpatient day across 50 states: FYI

Forbes' top 27 hospitals for diversity: FYICincinnati's Children Hospital is at the top of the list.

About pharma

House votes to extend ban on fentanyl-like substances: “The House easily passed legislation on Wednesday to extend a ban on copycats of fentanyl, a highly addictive synthetic opioid, that is set to expire on May 6 without congressional action.
Lawmakers passed the bill by voice vote to extend through Oct. 22 the federal government's ability to regulate fentanyl analogues as one of the most strictly controlled drugs with no accepted medical use and a high potential for abuse.”

Roche confirms outlook despite drug sales falling 14% in Q1:
Pharmaceuticals division sales: CHF 10.6 billion ($11.5 billion), down 14%
—Overall revenue: CHF 14.9 billion ($16.2 billion; forecasts of CHF 15 billion), down 1%

Combining AstraZeneca's 'good' cholesterol booster with PCSK9 inhibition shows promise in heart disease: “…the company has early data showing an experimental antibody drug increases HDL-C in monkeys and people. Combining the drug with a PCSK9 inhibitor appears to have a synergistic effect.”

Drug spending is climbing amid the pandemic, but not at hospitals: “The country's total drug spending rose by nearly 5 percent in 2020, but drug spending at hospitals declined by the same percentage, according to a report published April 21 by the American Society of Health-System Pharmacists.
Total U.S. drug spending was $535.3 billion in 2020. The drug spending categories that experienced the biggest increases were home healthcare (13 percent), mail-order prescriptions (9 percent) and clinics (8 percent). 
Drug spending at hospitals decreased by 5 percent, as patients delaying care amid the pandemic correlated with decreased drug utilization in hospitals.”

Eli Lilly retakes innovation crown, while Bristol Myers rates most inventive pharma in annual study: “If you gave a pharma a molecule, which one would make the most of it? Eli Lilly, according to IDEA Pharma’s most recent evaluation.
It ranks innovation as a measure of a pharma company’s ability to deliver a ‘return on invention’ over the past five years.”

Biotech Stocks Fall Out of Favor After Disappointing Trial Results, Big Rally: “Biotech shares have slumped in recent months, stung by setbacks in clinical trials and a rotation away from growth stocks after a steep rally in 2020.
The Nasdaq Biotechnology Index has fallen 10% from its Feb. 8 record, lagging behind the S&P 500, which has gained 6.6%, and the technology-laden Nasdaq Composite, which has slipped 0.3%, over that period. The decline has left the biotech index up 2.2% for the year, compared with respective gains of 11% and 8.2% for the other two indexes.”
The article offers several reasons for this poor performance.

About healthcare IT

Cerner inks 2nd life insurance industry partnership: “Cerner is teaming up with the MIB Group, which provides data-driven underwriting services to life insurance companies, as the EHR vendor looks to build on its life insurance industry initiatives.
In March, Cerner partnered with New York Life Insurance Co., giving the New York City-based mutual life insurer access to – with patient consent – Cerner's hospital clients' EHRs in near real time.
MIB provides data-driven risk management and digital services; through the new agreement, MIB will manage access to 54 million patient medical records from Cerner, as well as 5,400 distinct patient portals.”

Google cracks down on insurance advertisements posted on search engine: “Starting next month, Google will require health insurers to apply for certification for their ads to run on the search engine.
The tech giant announced Tuesday that it will only allow insurance ads from certified government exchanges, first-party providers and licensed third-party brokers.”

About health insurance

New health plans that track internet activity face federal litigation: “The U.S. Department of Labor is fighting a federal judge's decision that allows two companies to sell health plans to people who agree to internet tracking…
The employee health plans are offered to people who agree to become ‘limited partners’ of a firm called Data Marketing Partnership. Under the agreement, individuals' internet activity is tracked and sold…
The new plans wouldn't be required to offer the ACA's 10 essential health benefits or insure people with preexisting conditions. However, proponents of the plans argue they don't violate federal or state laws.”

Today's News and Commentary

About Covid-19

Most Americans say they should be vaccinated before the U.S. donates Covid-19 shots elsewhere: “Three-quarters of Americans believe the U.S. government should start donating Covid-19 vaccines to other countries, but only after every person in the U.S. who wants a vaccine has received one, according to a new survey from STAT and The Harris Poll.
At the same time, just over half of Americans said they agree with the idea that the Biden administration should immediately start donating vaccines to other countries in order to achieve global herd immunity, which reflects growing concern that the coronavirus cannot be contained until most of the world is vaccinated…
Not surprisingly, there are diverging views among different slices of those polled. More members of Gen Z and millennials — 59% and 65%, respectively — than middle-aged or older Americans believe the U.S. government should start to immediately donate Covid-19 vaccines to other countries. And 63% of Democrats support immediate donations, compared with just 43% of Republicans.”

The US is vaccinating millions of Americans daily. But here's why Covid-19 cases and hospitalizations are up: “In the past seven days, the US reported an average of more than 67,100 new Covid-19 infections daily, according to Johns Hopkins University data. That's slightly below where the average was a week prior, but it's still 25% above where it was nearly a month ago.
And about 44,000 Covid-19 patients were in US hospitals as of Sunday, the most recent day that data was available, according to the US Department of Health and Human Services. That number has generally been inching up since late March, when it dipped to around 37,900.
Experts say there are several reasons for the rise in these numbers, including dangerous coronavirus variants -- such as the more contagious B.1.1.7 strain that has helped fuel another surge in Michigan. Pandemic fatigue and more Americans moving around have also likely contributed to the rise.”

FDA unlocks pooled COVID-19 screening for previously authorized tests: “The FDA is making it easier for the makers of authorized COVID-19 tests to have multiple samples tested at once—allowing more people to be screened more regularly while using fewer resources.
This pooled testing approach has been previously green-lit by the agency for individual companies since last summer; the strategy only checks single samples when the larger batch returns a positive result.
Now, the FDA will begin issuing amendments to a potentially broad number of its past authorizations for certain molecular diagnostics—including those for people who are showing no symptoms, and only require a simple swab of the front of the nose, compared to the deeper nasopharyngeal swabs common during the early phases of the pandemic.”

The US spat over the vaccine IP waiver: A really good summary of the issue of sharing IP for the
Covid-19 vaccines.

GOP Reps Introduce Bill To Get Vaccines To Citizens First: “The same day that adults in all 50 states became eligible for the COVID-19 vaccine, Republican legislators introduced a bill on Monday to prioritize U.S. citizens and green card holders for the shot over everyone else in the country.
U.S. Reps. Fred Keller and Mike Kelly, R-Pa., and Rep. Nancy Mace, R-S.C., said that the Saving Hypodermic injections and Offering vaccines to Taxpayers Swiftly, or SHOTS, Act would instruct the U.S. Department of Homeland Security to ‘ensure that American citizens and lawful permanent residents are given priority to receive the COVID-19 vaccine over those visiting or who have entered the United States illegally.’”
The legislators obviously missed the memo that everyone needs to be immunized if “American citizens and lawful permanent residents” are to be safe.

House Democrats launch investigation into J&J contractor Emergent: “House Democrats have launched an investigation into Emergent BioSolutions, the embattled contract manufacturer of Johnson & Johnson's coronavirus vaccines, to find out if the company used its relationship with a key Trump administration official to secure federal contracts.
In a letter sent to the company's CEO and its executive chairman, Democrats on the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis said they were concerned Emergent won contracts ‘despite a track record of increasing prices without justification and failing to meet contract requirements.’”

About health insurance

Anthem raises outlook as it posts $1.7B in Q1 profit:”Profits were up 9.3% from the first quarter of 2020, according to the insurer's financial release, when the company brought in $1.5 billion.
Revenues were $32.4 billion for the quarter, which fell short of expectations from Zacks Investment Research. Revenue was also up 9.3% year over year, Anthem said, from $29.6 billion in the first quarter of 2020.”
The expectations in this sector were for profits to decline as Covid-19-postponed care surged back.

Aetna bringing CVS-centric plan to new markets with eye on further expansion: “Aetna first unveiled its Connected Plan last year, and now it's bringing the design to new markets with its sights on even further expansion.
The Aetna Connected Plan with CVS Health centers the capabilities of the insurer's parent company, including its retail pharmacies, MinuteClinics and HealthHUB stores. After launching in the Kansas City market, the plan is now coming to Southern California and St. Louis.
Aetna is aiming to offer the plan in 15 markets by the end of the year…”

Texas’ Obamacare Medicaid Provider Fee Case Headed to SCOTUS: “Texas and five other states will be asking the U.S. Supreme Court to hear their objections to an Obamacare program that cost them nearly $500 million in ‘health insurer premium’ fees imposed on Medicaid managed care companies.
The U.S. Court of Appeals for the Fifth Circuit agreed to halt the issuance of a mandate confirming the states’ liability for the tax until Sept. 6 or the states’ filing of a petition for review by the nation’s top court, whichever occurs first.
The Affordable Care Act’s Section 9010 taxes health insurers on the premiums they charge states for Medicaid managed care...”

2019 Medicare Current Beneficiary Survey Early Look: This report was just released (despite the date on the headline): Highlights:
77% of Medicare beneficiaries report good, very good, or excellent health.
48% of Medicare beneficiaries report having one or more disabiities.
The vast majority of Medicare beneficiaries are satisfied with health care quality, ease of access, and cost (see Table 4)

Mass. Eye And Ear Agrees To Pay $2.7M To Resolve Fraud Complaint: “A Boston hospital that specializes in eye, ear, nose and throat ailments has agreed to pay $2.7 million to resolve federal fraud allegations, Acting U.S. Attorney for Massachusetts Nathaniel Mendell announced Tuesday.
Prosecutors say Massachusetts Eye and Ear improperly billed government health care programs for certain office visits, defrauding the country of more than a million dollars.”

Oscar Health launches tech platform business +Oscar: “Oscar's health plans are built on the technology infrastructure, and it has entered into a number of partnerships with others in the industry, including Cigna and Cleveland Clinic, that harness that tech stack to enhance the member experience and simplify administrative tasks.
Through +Oscar, provider-sponsored health plans and regional insurers can operate at a similar level of efficiency to larger payers despite the smaller scale, Oscar Health said.”

Cigna accuses Connecticut physician practice of price gouging: “A Connecticut physician practice suing Cigna over COVID-19 payments exploited a national health emergency and overcharged insurers for diagnostic tests, Cigna claimed in recent court filings.
The price gouging claims come amid a legal battle between Cigna and Murphy Medical Associates, an internal and preventive medical practice in Southwestern Connecticut. In an amended complaint filed March 24, Murphy Medical accused Cigna of failing to provide coverage for COVID-19 testing and related services.”

Assessment of Potentially Preventable Hospital Readmissions After Major Surgery and Association With Public vs Private Health Insurance and Comorbidities: “This cohort study using a weighted sample of 1 937 354 patients found that 18% of readmissions within 90 days of hospital discharge were for a potentially preventable cause. Public insurance, compared with private insurance, was associated with an increased risk of potentially preventable readmission….
This study suggests that improved access to ambulatory care in the postoperative period, particularly for high-risk patients, may be associated with a substantial reduction in postoperative readmissions after major surgery.”

About healthcare IT

Global investment in telehealth, artificial intelligence hits a new high in Q1 2021: “Telehealth investment hit an all-time high of $4.2 billion in just 139 deals in the first quarter, almost doubling the $2.2 billion raised in the same quarter a year ago, according to CB Insights.
That's the highest global funding for telehealth during one quarter on record, according to the company's first-quarter 2021 report. Funding also was up 18% from the $3.6 billion raised in the fourth quarter of 2020.”

The telehealth services Blue Cross Blue Shield is making permanent: “While Blue Cross Blue Shield has not made a companywide announcement on where telehealth stands after the pandemic, its subsidiaries have been individually sharing where they are in their plans.”
The article has brief statements on what 7 Blues Plans are doing.

The association between perceived electronic health record usability and professional burnout among US nurses: “The mean nurse-rated EHR SUS [System Usability Scale: 0-100] score was 57.6 (SD 16.3). A score of 57.6 is in the bottom 24% of scores across previous studies and categorized with a grade of ‘F.’ On multivariable analysis adjusting for age, gender, race, ethnicity, relationship status, children, highest nursing-related degree, mean hours worked per week, years of nursing experience, advanced certification, and practice setting, nurse-rated EHR usability was associated with burnout with each 1 point more favorable SUS score and associated with a 2% lower odds of burnout (OR 0.98; 95% CI, 0.97–0.99; P < .001)…[In other words,] EHR usability and the odds of burnout were strongly associated with a dose-response relationship.”
See hospitals and health systems below for a nursing shortage article.

About pharma

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics: “This study found that older adults and Black patients were underrepresented in postmarketing studies of novel cancer therapeutics to a similar degree that they were underrepresented in premarketing studies. These findings suggest that postmarketing studies are not associated with improvements to gaps in demographic representation present at the time of FDA approval.”

J&J's sales of prescription drugs up 9.6% in Q1, topping forecasts:
—Prescription drug sales: $12.2 billion (forecasts of $12.1 billion), up 9.6%
—Overall revenue: $22.3 billion (forecasts of $22 billion), up 7.9%
—Profit: $6.2 billion, up 6.9%
”The company noted that sales growth of prescription drugs was driven by Darzalex, Erleada, Imbruvica, Invega Sustenna/Xeplion/Invega Trinza/Trevicta, Stelara and Tremfya, partially offset by declines for Remicade and Zytiga due to biosimilar and generic competition.
Johnson & Johnson noted that its COVID-19 vaccine Ad26.COV2.S generated sales of $100 million in the first quarter, despite its use being paused in the US and rollout delayed in Europe due to concerns over blood clots.”

FDA loses ‘drug or device’ argument again: “A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.
Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does…
Genus estimated the cost of seeking clearance to market its product as a device at $60,000, whereas seeking approval to market it as a drug could exceed $500,000, plus a continuing annual cost of more than $186,000, according to the court order dismissing the FDA’s motion for summary judgment…
[T]he appeals court agreed with a lower court in ruling that the FDCA [Food Drug and Cosmetic Act] ‘unambiguously forecloses the FDA’s interpretation,’ granting summary judgment in Genus’s favor and vacating the FDA decision to classify Genus’s products as drugs. ‘We agree with the district court that the text, statutory structure and legislative history of the Act make plain that the Congress did not grant the FDA such sweeping discretion,’ circuit judge Karen L. Henderson wrote for the court.”
Since some products can be classified as a device or drug at the FDA’s discretion, this decision is significant in the boundaries it puts on such discretion.

About hospitals and health systems

Hospital executives report high nursing vacancies, greater reliance on costly travel nurses: “Thirty-six percent of hospital executives say they anticipate more than 25 openings this year compared to 17% in 2020, while 21% anticipated more than 50 opens and 11% predicted more than 100 open positions, according to a survey conducted by Avant Healthcare Professionals
Seventy percent of the respondents reported losing anywhere from 5% to 30% of their staff as a direct result of COVID-19.New graduates and internal recruitment are the primary strategies these organizations will employ to address those vacancies, although many fewer respondents said they were focusing on that second option in 2021 compared to the year prior (45% versus 70%).”

Tenet posts $97M in profit in Q1 due to higher acuity patients: “Hospital chain Tenet Healthcare posted $97 million in profit in the first quarter of the year, up slightly from the $94 million it earned the same period in 2020 before the COVID-19 pandemic took hold.
Overall, Tenet Wednesday reported $3.9 billion in revenue for the hospital segment, up by nearly 3% from the $3.8 billion in the first quarter of 2020. Patient service revenue was also $3.6 billion in the first quarter compared with $3.5 billion in the first quarter of 2020.
‘The increase in revenues was primarily due to higher patient acuity and commercial payer mix, which more than offset lower patient volumes as a result of COVID,’ Tenet said…”

Today's News and Commentary

About Covid-19

All U.S. adults now eligible for COVID-19 vaccine: how to find a shot: “American adults in all 50 states as well as the District of Columbia and Puerto Rico are now eligible for the coronavirus vaccine as of Monday, meeting President Biden's goal of April 19 eligibility…
Perhaps the easiest resource to use to find a vaccine — and one the Centers for Disease Control points people toward — is VaccineFinder.org.”

New U.S. COVID cases fall 0.4% last week, after rising for four weeks: “Health experts say new cases have plateaued at a high level as more infectious variants of the virus offset progress made in vaccinations. The country logged nearly 70,000 new cases per day in the week ended April 18, compared with 55,000 new cases a day in March and about 30,000 new cases this time last year.”

J&J vaccine should be administered with warning label, EU regulator says: “The European Medicines Agency, the European Union's equivalent to the FDA, said April 20 that the bloc should not ban Johnson and Johnson's COVID-19 vaccine, but a label should be added to warn about the rare possibility of blood clots.”

‘I’m still a zero’: Vaccine-resistant Republicans warn that their skepticism is worsening: “Although more than half of U.S. adults have received at least one dose of coronavirus vaccine, more than 40 percent of Republicans have consistently told pollsters they’re not planning to be vaccinated.” The article offers why participants in a small focus group were not swayed by certain information.

Statement on the seventh meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic: One recommendation from the WHO in this long list Is: “Do not [emphasis in original] require proof of vaccination as a condition of entry, given the limited (although growing) evidence about the performance of vaccines in reducing transmission and the persistent inequity in the global vaccine distribution. States Parties are strongly encouraged to acknowledge the potential for requirements of proof of vaccination to deepen inequities and promote differential freedom of movement.”

COVID-19 neuropathology at Columbia University Irving Medical Center/New York Presbyterian Hospital: The brain abnormalities in COVID-19 patients are thought to be the result of systemic inflammation rather that direct viral infection of the central nervous system.

About health insurance

AHA counters site-neutral Medicare payments with study highlighting hospitals' more complex outpatients: ”The American Hospital Association (AHA) is reinforcing its longstanding position against the Department of Health and Human Services’ (HHS') site-neutral payments with new research suggesting hospital outpatient departments are treating poorer, more complex Medicare patients than independent physicians' offices are.
The study, which was conducted for the AHA by KNG Health Consulting and published on its website, reviewed claims from a 5% sample of Medicare beneficiaries who had at least one visit to an outpatient setting between Jan. 1, 2012, and June 3, 2019…
The linchpin of AHA’s interest in the two settings is a legal back and forth regarding the 2019 Outpatient Prospective Payment System rule (PDF), which brings reimbursement to each setting in line with the end goal of reducing payment disparity.”

Insurers are integrating telehealth companies:
Evernorth Completes Acquisition of MDLIVE to Expand Access to Virtual Care: “Evernorth, the health services portfolio of Cigna Corporation, today announced that it has completed its acquisition of MDLIVE, a privately held, leading 24/7 virtual care delivery platform. The transaction, first announced on February 26, expands Evernorth’s capabilities to lower the cost of care – while increasing access to health care providers – through virtual visits that can be accessed from the home or anywhere.” And:
Optum launches virtual care offering nationwide: 5 things to know: “The new virtual care product, dubbed Optum Virtual Care, is now live in all 50 states, said OptumHealth CEO Wyatt Decker during UnitedHealth Group's Q1 2021 earnings call transcript…”

Humana overcharged Medicare nearly $200M, inspector general finds: “Health insurer Humana failed to comply with some federal coding requirements, resulting in overpayments of $197.7 million, according to an inspector general's report released April 20.
Under the Medicare Advantage program, CMS makes monthly payments to organizations according to a system of risk adjustment determined by the health status of each enrollee. According to the federal audit, Humana failed to submit some diagnosis codes to CMS for use in the risk adjustment program.”

Health insurance execs push back against tax in Connecticut: “In a letter to Connecticut Gov. Ned Lamont, payer executives argued against a bill that would impose a $50 million tax on insurance companies, potentially driving businesses out of the state, according to the Hartford Courant.
The April 13 letter was signed by Anthem CEO Gail Boudreaux, Harvard Pilgrim Health Care and Tufts Health Plan CEO Thomas Croswell, Cigna CEO David Cordani, UnitedHealth Group President and COO Dirk McMahon and CVS Health CEO Karen Lynch.”

About the public’s health

Biden Administration Considering Rule to Cut Nicotine in Cigarettes: “The Biden administration is considering requiring tobacco companies to lower the nicotine in all cigarettes sold in the U.S. to levels at which they are no longer addictive, according to people familiar with the matter.
Administration officials are considering the policy as they approach a deadline for declaring the administration’s intentions on another tobacco question: whether or not to ban menthol cigarettes.”

Toward a fine-scale population health monitoring system: “Epidemiology research often relies on definitions of race and ethnicity, but these population labels may not adequately capture disease burdens and environmental factors impacting specific sub-populations. Here, we propose a framework for repurposing data from electronic health records (EHRs) in concert with genomic data to explore the demographic ties that can impact disease burdens…This work reinforces the utility of linking genomic data to EHRs and provides a framework toward fine-scale monitoring of population health.”

About healthcare personnel

Healthcare loses 44,000 jobs during Q1 2021, while spending, prices continue to grow: “Employment in the U.S. healthcare industry has dropped by 44,000 jobs over the course of the first quarter of 2021…
These job losses came alongside continued spending growth recovery and increases in overall healthcare prices.
Modest employment gains in February and March were unable to offset January’s substantial decline of 80,000 healthcare jobs.
Many of these losses were felt among hospitals, which lost 37,000 jobs in the first quarter, and nursing and residential care, which dropped 38,000 jobs. On the other hand, ambulatory care settings picked up 37,000 new jobs in the first three months of the year.
Overall, the healthcare industry has lost a total of 557,000 jobs since February 2020’s pre-COVID-19 peak, a 3.1% decline.”

About pharma

Relatively Few Drugs Account for a Large Share of Medicare Prescription Drug Spending: Among the study’s findings:
—”The 10 Top-Selling Part D Drugs - Less than 1% of Covered Drugs - Accounted for 16% of Net Total Part D Spending in 2019” and
—”The Top 50 Part B Drugs - Less Than 10% of Covered Drugs - Accounted for 80% of Total Part B Drug Spending in 2019”
Cost-control efforts will not be affected by such concentrated spending.

California counties seek billions of dollars from drugmakers in opioid trial: “Johnson & Johnson, Teva, Endo and AbbVie’s Allergan are accused of falsely marketing painkillers and knowingly underplaying the risk of addiction in order to increase sales, in litigation brought by three California counties and the city of Oakland, which are seeking billions of dollars in damages.”

Six Individuals Sentenced for Nearly $8 Million Health Care Fraud Involving Northern Virginia Pharmacies: “According to court documents, Mohamed Abdalla, 48, of Allendale, New Jersey, owned multiple pharmacies in northern Virginia, including Medex Health Pharmacy in Falls Church and Royal Care Pharmacy in Fairfax. As the owner of these pharmacies, Abdalla oversaw and executed two related schemes to defraud health care benefit programs. One scheme involved the payment or receipt of unlawful kickbacks for expensive drugs and devices in violation of the federal Anti-Kickback Statute. Another scheme involved billing federal, state, and private health care benefit programs for numerous expensive drugs and devices that were not medically necessary, not prescribed by a physician, or were not received by a beneficiary.”

About healthcare IT

2021 White Paper: Setting Healthcare on FHIR [Fast Healthcare Interoperability Resources]: A good monograph updating the status of FHIR and IT interoperability, in general.

Promise and peril: How artificial intelligence is transforming health care: A good, in-depth (221 pages) look at this topic from STAT and the Commonwealth Fund.

Today's News and Commentary

About Covid-19

CVS, Walgreens begin rolling out over-the-counter COVID tests from Abbott, Ellume and more: The tests are available without a prescription.

Worldwide COVID-19 death toll tops a staggering 3 million: “The global death toll from the coronavirus topped a staggering 3 million people Saturday amid repeated setbacks in the worldwide vaccination campaign and a deepening crisis in places such as Brazil, India and France.
The number of lives lost, as compiled by Johns Hopkins University, is about equal to the population of Kyiv, Ukraine; Caracas, Venezuela; or metropolitan Lisbon, Portugal. It is bigger than Chicago (2.7 million) and equivalent to Philadelphia and Dallas combined.
And the true number is believed to be significantly higher because of possible government concealment and the many cases overlooked in the early stages of the outbreak that began in Wuhan, China, at the end of 2019.”

Study of More Than 3,000 Members of the US Marine Corps. Reveals Past COVID-19 Infection Does Not Fully Protect Young People Against Reinfection: “Although antibodies induced by SARS-CoV-2 infection are largely protective, they do not completely protect against reinfection in young people, as evidenced through a longitudinal, prospective study of more than 3,000 young, healthy members of the US Marines Corps…”

Pfizer, Moderna turned down J&J request to probe COVID-19 vaccine clotting risks: report: Interesting marketing ploy by J&J to involve its competitors in looking for clotting complications. Pfizer and Moderna are required to look for complications, so there is no public health advantage to this joint effort.

About pharma

Facebook unveils AI model to mix up cancer-curing cocktails with existing drugs: “The social media giant’s AI research department and the Helmholtz Zentrum München, a research center in Germany focused on environmental health, unveiled an open-source AI model designed to determine the viability of repurposing existing drugs into new pharmaceutical cocktails.
Researchers and biologists now have free access to the Compositional Perturbation Autoencoder, or CPA, which evaluates the effects of drug combinations in varying dosages—a complicated task, as the number of possibilities can accelerate exponentially into the billions as more medicines are thrown into the mix.
The model predicts not only how the drugs interact with one another, but also how they might work together to attack specific cell types and interrupt diseases.”

Surprise: AstraZeneca's $39B Alexion buy clears a newly vigilant FTC without a hitch: “In an anticlimactic announcement Friday, AZ said the U.S. Federal Trade Commission has cleared the $39 billion deal first unveiled in December. 
None of the extra antitrust hurdles that analysts had feared for the marriage actually happened. The FTC didn’t attach any extra conditions to the deal. In fact, the go-ahead simply followed the 30-day waiting period triggered when the companies refiled their transaction for review on March 16.”

Merck Halts Development of MK-7110 for COVID-1: “Merck announced that it will end research and development on MK-7110, an experimental oral drug for treatment of hospitalized coronavirus patients that had shown promise in a late-stage trial.
The pharma titan said last week that it would drop its efforts on the drug — which it obtained through a $425 million acquisition of OncoImmune in November 2020 — after the FDA said it would need to see additional data beyond OncoImmune’s study to potentially grant Emergency Use Authorization.”

The top 10 ad spenders in Big Pharma for 2020: “Total pharma advertising spending topped $6.58 billion in 2020, according to Kantar measured media. That’s just a notch above the 2019 total of $6.56 billion, but still noteworthy in a year that saw U.S. advertising spend drop by 13% overall…
Pharma spending on digital video—desktop and mobile—increased 43%, while print and out-of-home channels dropped by 16% and 81%, respectively, according to Kantar.
Pharma TV advertising remained the cornerstone of spending with $4.58 billion, a whopping 75% of the total spend. That’s up just slightly from 2019 when national TV was 73% of pharma’s investment.”
#1 on the list of top spenders is Humira.

About health insurance

Trump tried to shrink Medicaid. Here's how Biden will try to expand it.: A really good overview of the Biden Administration’s Medicaid expansion initiatives. And in a related article: Biden officials rescind Trump’s okay for Texas’s $100 billion-plus Medicaid plan: “‘[W]e are rescinding the approval issued on January 15, 2021,’ because it did not go through the full federal rulemaking process, Liz Richter, the acting administrator of the Centers for Medicare and Medicaid Services, wrote in a letter to Texas officials obtained by The Washington Post.”

Nonprofit Health Plans Launch Telehealth-First Options to Increase Access and Affordability: ”When Covid-19 drove an increased need for telehealth in care delivery and coverage, nonprofit health plans Harvard Pilgrim, Kaiser Permanente, and Priority Health adapted their reimbursement models for members across the United States and accelerated their time lines for bringing cost-effective virtual care insurance products to market.”

Voya research shows employees are biased toward HDHPs [High Deductible Health Plans]: The headline should say “against” HDHPs. “New research from Voya shows employees have a bias against HDHPs and the reason for that is as simple as marketing…’When we replaced the high deductible health plan name and called it something more generic, the share of people choosing high deductible health plans doubled. So just the name itself can have a really significant impact on how people think about what plan they should choose.’
Sixty-three percent of the people surveyed by Voya said they would choose the plan with the lowest deductible. As part of the study Voya designed an experiment asking participants to choose between a PPO and an HDHP. The experiment was set up in a way that the HDHP was always the optimal financial choice, despite this, 65% of those surveyed still chose the PPO plan.”



Today's News and Commentary

About Covid-19

U.S. preparing for 1-year COVID-19 booster shots; Pfizer chief sees need: “The United States is preparing for the possibility that a booster shot will be needed between nine to 12 months after people are initially vaccinated against COVID-19, a White House official said on Thursday.
While the duration of immunity after vaccination is being studied, booster vaccines could be needed, David Kessler, chief science officer for President Joe Biden's COVID-19 response task force told a congressional committee meeting.”

Up to 10% of young adults who recover from COVID-19 at risk for reinfection: “About 10% of 18- to 20-year-olds included in the analysis developed a case of the virus despite being infected earlier in the pandemic, the data showed.”

CureVac preps its COVID-19 shot for deployment as J&J, AZ holdups slow Europe's rollout: “CureVac, which has started a rolling review process for its two-dose vaccine with the European Medicines Agency, plans to release late-stage trial results in the coming weeks, CEO Franz-Werner Haas said on a call with analysts Thursday. Depending on the results, the company expects that EU authorization for its shot, CVnCoV, could come in the beginning of June…”

The dogtor is in: Study finds dogs can sniff out COVID-19 with 96% accuracy: The headline is the story.

Web-based calculator for individual Covid-19 mortality risk: Enter your info to get an estimate.

U.S. to spend $1.7 billion on fighting variants: ”The Biden administration announced Friday it is allocating $1.7 billion to fight coronavirus variants, as the virus continues to mutate into more deadly and infectious forms.
The spending is aimed at improving the detection, monitoring and mitigation of the variants, as the original strain of the novel coronavirus now makes up only about half of all cases in the country. The White House said a central goal of the effort will be increasing the country’s capabilities for genomic sequencing to better understand and track mutations.”

About the public’s health

The Impact of Social Determinants of Health on Health Equity and Their Root Causes: A nice overview of the issue and insurance recommendations from AHIP.

About health insurance

A Public Option for Health Insurance in the Nongroup Marketplaces: Key Design Considerations and Implications: A good overview of questions and possible answers by the CBO.

3 takeaways from Brooks-LaSure's confirmation hearing to become administrator of CMS: The three categories were: Making telehealth flexibility permanent; Improving dual-eligible care coordination; and Flexibility and certainty for states applying for waivers.
No opposition is expected to her confirmation.

Employers Must Find, Tell Laid-Off Workers of Health Subsidies: “Employers have little time to waste in identifying and notifying laid-off employees who qualify for free health-care coverage under the American Rescue Plan signed into law last month by President Joe Biden.
The law provides fully subsidized coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) from April 1 through Sept. 30 for employees who were involuntarily laid off or lost their job-based health plans due to reduced hours during the Covid-19 pandemic.”

About pharma

FDA Approves Genentech’s Xolair for Self-Injection Across Indications: “The agency approved the company’s supplemental Biologics License Application (sBLA), allowing the self-injected product to be used for treating moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps. The drug works by targeting and blocking the antibody immunoglobulin E.
Patients must have ‘no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity,’ Genentech said.”
Because of its cost, this drug has been on many prior-authorization lists. With a change to self-administration, it will probably move from the medical to the pharmacy benefit and be subject to new reviews.

Biden administration poised to change Trump restrictions on fetal tissue research: The announcement is expected today, but details are not yet out.

Global shortage of innovative antibiotics fuels emergence and spread of drug-resistance: “The world is still failing to develop desperately needed antibacterial treatments, despite growing awareness of the urgent threat of antibiotic resistance, according to report by the World Health Organization. WHO reveals that none of the 43 antibiotics that are currently in clinical development sufficiently address the problem of drug resistance in the world’s most dangerous bacteria.”

About healthcare IT

Roche, Biocorp begin French rollout of add-on device connecting insulin pens to smartphone apps: “The French device maker’s smart sensor connects to most disposable insulin injection pens to collect data about each injection. Mallya automatically transmits that data to Roche’s Gluci-Chek smartphone app over Bluetooth. The dosage, insulin type, date and time information can then be logged and shared with healthcare providers via the Roche Diabetes Care Platform.
The sensor collects data with at least 99% accuracy, according to Biocorp, and it has received a CE mark for distribution in Europe. It lasts about two years and can be recharged through a USB port.”

TELEHEALTH IMPACT: PATIENT SURVEY ANALYSIS: “The patient survey was drafted by the COVID-19 Telehealth Impact Study Work Group” to answer these questions:

  1. “How well did telehealth serve the clinical needs of patients during the COVID-19 pandemic?

  2. For what reasons did patients seek care through telehealth?

  3. What were the strengths and weaknesses of telehealth related to quality of care?

  4. What are patients’ expectations for the use of telehealth after the pandemic?”

The report has helpful graphics to answer those questions by age, insurance, rurality and “all.”

In a sharp rebuke, health officials toss Trump-era proposal to exempt medical AI tools from review: “In a searing rebuke, the Biden administration is formally withdrawing a last-minute proposal by the Trump administration to exempt a wide swath of medical devices and artificial intelligence tools from regulatory review.
Officials with Biden’s Health and Human Services Department and the federal Food and Drug Administration posted a document on the federal register indicating that they will not proceed with the proposed exemptions.”

FCC will begin accepting applications for its $250M COVID-19 telehealth program starting April 29: “The Federal Communications Commission has set a date for healthcare providers to submit applications for the second round of the COVID-19 Telehealth Program, which will distribute nearly $250 million to support telehealth services.
The window opens at noon on April 29 and will last one week until May 6, 2021, according to the FCC. Interested providers will be able to submit their applications through a dedicated portal to be made available on the agency’s COVID-19 Telehealth Program webpage.”

RCM vendor data breach affects 136,000: 5 hospitals, health systems involved: “An investigation concluded that a former employee saved PHI to personal folders and uploaded the files to a public website.
There are at least five health systems and hospitals affected by the breach. HHS' data breach portal reported 135,908 individuals have been affected.”

About healthcare professionals

Medscape Physician Compensation Report 2021: The Recovery Begins: Read the report for a full analysis. At the top is plastic surgery. At the bottom is pediatrics.

Optum on track to exceed physician hiring goal, CEO says: “The company announced plans to add 10,000 physicians in 2021 earlier this year, and Wyatt Decker, CEO of OptumHealth, said Optum is on track to exceed that number. Optum now has 56,000 affiliated, contracted and employed physicians.”

Today's News and Commentary

About Covid-19

J&J's COVID-19 vaccine remains paused in US as advisory panel seeks more data: “Advisers to the US Centers for Disease Control and Prevention (CDC) said Wednesday that they need further data in order to make recommendations on how to respond to reports of cerebral venous sinus thrombosis (CVST) in some people administered Johnson & Johnson's COVID-19 vaccine Ad26.COV2.S. The Advisory Committee on Immunization Practices (ACIP) is expected to meet again within a week to 10 days.”

Novavax Admits Supply Shortages Will Delay Vaccine Production: “Novavax said it does not expect to hit its target of manufacturing 150 million COVID-19 vaccine doses per month until the third quarter of this year.
The production delay is caused in part by problems with the bioreactors used to grow cells needed for manufacturing the vaccine.”

Former world leaders call on Biden to suspend Covid-19 vaccine patents: “A group of 175 former world leaders and Nobel laureates is urging the US to take “urgent action” to suspend intellectual property rights for Covid-19 vaccines to help boost global inoculation rates. A measure to allow countries to temporarily override patent rights for Covid-related medical products was proposed at the World Trade Organization by India and South Africa in October, and has since been backed by nearly 60 countries. Doing so would allow developing countries to make their own copies of the vaccines that have been developed by pharmaceutical companies without fear of being sued for intellectual property infringements.”

AstraZeneca vaccine elicits stronger T-cell response in elderly than Pfizer jab: “The Oxford/AstraZeneca vaccine induced a stronger cellular immune response in elderly adults than the BioNTech/Pfizer shot, potentially providing more protection against severe Covid-19 and new virus variants. In the first head-to-head comparison of the two vaccines, scientists discovered that both shots elicited an antibody response in the group of over-80s, tested five to six weeks after the first shot. However, participants who received the AstraZeneca jab were more likely to also have a T-cell response.”

Many millions have been vaccinated against the coronavirus; 396 were later hospitalized with Covid-19: “About 5,800 people who have been vaccinated against coronavirus have become infected anyway, the US Centers for Disease Control and Prevention tells CNN. 
Some became seriously ill and 74 people died, the CDC said. It said 396 -- 7% -- of those who got infected after they were vaccinated required hospitalization.
This is the CDC's first public accounting of breakthrough cases, and the agency is searching for patterns based on patient age and gender, location, type of vaccine, variants and other factors.”

About healthcare IT

Coding to Hide Health Prices from Web Searches Is Barred by Regulators: “Federal regulators said healthcare pricing data that health insurers must post under a new requirement shouldn’t be blocked from web searches, issuing new guidance after The Wall Street Journal reported that hospitals used special coding that shielded such information from Google and other search engines.
Under new federal requirements, both hospitals and insurers must reveal long-confidential pricing data, including the rates that insurers pay for services. Hospitals were supposed to post data at the start of this year, while insurers must comply beginning in 2022. The hospital industry had fought the requirement in court but lost.”

IBM finds more cyberattacks against COVID-19 vaccine supply chain: “A hacking campaign detected by IBM tried to attack the organizations involved in manufacturing, transporting and storing COVID-19 vaccines last year. Now it has been found to be a much bigger operation than was originally thought.”

VA pauses $16B Cerner EHR rollout for 3rd time: 6 details: The long saga continues: “The Department of Veterans Affairs is pausing deployment activities for its new $16 billion Cerner EHR system at a second site until it has completed a strategic review of the project and shared the results with Congress, according to an April 14 Federal News Network report.”

About the public’s health

Explore the Management Top 250: How does your company rank in the 2020 analysis of well-run companies for customers, employees and investors?: By far the #1 company is Microsoft. The highest ranked healthcare company is Merck (#11).

About health insurance

What if the American Rescue Plan’s [ARPA]Enhanced Marketplace Subsidies Were Made Permanent? Estimates for 2022: “We find the number of people uninsured would drop by 4.2 million, or almost 14 percent, in 2022 if the ARPA’s enhanced marketplace subsidies were permanent and consumers, employers, and insurers responded to the new subsidy schedule as if it were fully phased in. We estimate subsidized marketplace enrollment would increase by 5.1 million people, an increase of 60 percent in 2022. Because of our different assumptions and models, our estimates differ from those by the Congressional Budget Office (CBO).”

Change Healthcare shareholders approve $13B UnitedHealth deal: ”Shareholders of Change Healthcare approved a $13 billion deal to become part of UnitedHealth Group's OptumInsight…
The approval comes as the deal is facing scrutiny from the Department of Justice. The American Hospital Association had urged the department to investigate the deal, which the association claims is anticompetitive.“

Patient Recruiter Sentenced to Prison for $3.3 Million Cancer Genetic Testing Fraud Scheme: “According to court documents, [Andre] Scott was the owner of Scott Global, a telemarketing call center located in Orlando. The evidence showed that Scott targeted Medicare beneficiaries with telemarketing phone calls falsely stating that Medicare covered expensive cancer screening genetic testing, or ‘CGx’ tests. Each test cost as much as $6,000. After beneficiaries agreed to take the test, the evidence showed Scott paid unlawful bribes and kickbacks to telemedicine companies to obtain doctor’s orders authorizing the tests.”

About pharma

Biologics Legislation Is Headed to Biden's Desk for Signature: “The Advancing Education on Biosimilars Act would require more robust federal efforts to educate the public about biosimilars, and the Ensuring Innovation Act would impose more restrictions on what biologics and generics drugs qualify for product exclusivity protections.” The latter Act cuts the ability of pharma companies to maintain exclusivity by using patents on all chemical entities in the product. For non-biologics, the Act strikes ‘‘‘active ingredient (including any ester or salt of the active ingredient)’ each place it appears” and inserts ‘‘‘active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations)…’” The Acts await Presidential signatures.

Thermo Fisher Scientific to Acquire PPD, Inc., a Leading Clinical Research Organization: “Thermo Fisher Scientific Inc….and PPD, Inc….,a leading global provider of clinical research services to the pharma and biotech industry, today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt…
Upon close of the transaction, PPD will become part of Thermo Fisher's Laboratory Products and Services Segment.”

 

Today's News and Commentary

About Covid-19

Inhaled steroid speeds recovery in Covid patients at home, study finds: “A widely available asthma drug has been found to reduce the recovery time for Covid-19 patients treated at home by an average of three days, according to a large clinical study in the UK led by Oxford university. The interim results for the inhaled steroid, known as budesonide, provide the first statistically powerful evidence for a drug speeding recovery in people who are not hospitalised.”

Moderna study finds COVID-19 vaccine 90 percent effective six months after dose: “Moderna announced on Tuesday that their coronavirus vaccine was 90 percent effective six months after a person receives their second dose.
’Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates, including greater than 90% against all cases of COVID-19, and greater than 95% against severe cases of COVID-19,’ the company announced.
Moderna is working for its vaccine to be fully approved by the U.S. as it is only under emergency authorizations from the Food and Drug Administration.”

Pfizer expects to meet US supply target ahead of schedule as authorities halt use of J&J shot: ”Pfizer can meet its supply target with the US government two weeks early as it boosts production, the company's chief executive said on Tuesday.”

Regeneron Says Its COVID-19 Antibody Combination Cuts Symptomatic Infections:”Regeneron Pharmaceuticals said its COVID-19 antibody cocktail, REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81 percent in a late-stage trial…
Those treated with the antibody combination who suffered from symptomatic infection generally saw their symptoms end in one week vs. three weeks for the placebo arm in the study conducted with the NIH’s National Institute of Allergy and Infectious Diseases.” Here are the latest NIH treatment recommendations, including use of monoclonal antibodies.

A Guide To The 1st Appellate Clash Over COVID-19 Coverage: “On Wednesday, the Eighth Circuit will become the first appellate court to consider whether COVID-19 closures trigger business interruption insurance when it hears an Iowa dental clinic's appeal of an order that Cincinnati Insurance doesn't have to cover its pandemic-related losses.” The article provides an overview of this important, contentious issue.

Europe won't renew AstraZeneca, Johnson & Johnson COVID-19 vaccine contracts next year: report: “The European Commission has opted against renewing its vaccine contracts with AstraZeneca and J&J once they expire at the end of the year, Italian newspaper La Stampa reported Wednesday, citing an unnamed source from the Italian health ministry…
Both shots have come under scrutiny over rare but serious cases of blood clots in people who had received the vaccines, prompting several countries to halt use of the AZ shot while the European Medicines Agency completed a follow-up safety review. Meanwhile, AstraZeneca has struggled to meet the delivery targets it originally laid out, while J&J just this week said it would delay its vaccine rollout in the bloc over safety concerns.”

About healthcare IT

Biden outlines health IT funding priorities: “The extensive list includes billions in funding for public health data modernization, broadband and 5G expansion, social determinants of health, cybersecurity and more.” See the article for spending details.

Anthem, K Health, Blackstone launching joint digital health venture: “Hydrogen Health is backed by investment from Blackstone and Anthem, and K Health CEO Allon Bloch will serve as the new company's chief executive. Financial terms were not disclosed.
The new venture will harness K Health's artificial intelligence tools to bring new digital health offerings to the consumer and employer markets, according to an announcement from the companies. Hydrogen Health will develop new platforms targeting the direct-to-consumer, direct-to-employer and direct-to-insurer markets.”

CMS bans coding hospitals use to hide prices from web searches: The update is that: “Leaders of the House Energy and Commerce Committee sent a letter April 13 to HHS calling for strict enforcement of the price transparency requirements. The letter cited evidence of hospitals' lack of compliance, including the Journal's analysis of more than 3,100 sites that use the search-blocking code, according to the report.”

100 Million More IoT Devices Are Exposed—and They Won’t Be the Last: Not strictly healthcare-related, but this Wired e-zine article explains details of why the systems are vulnerable.

About the public’s health

Syphilis Cases in California Drive a Record-Setting Year for STDs Nationwide: “In California and the U.S., about half of syphilis cases are in men who have sex with men. More than a third of women in the West who have syphilis also use meth, which has surged in recent years. These are just some of the trends causing overall national cases of sexually transmitted diseases to hit an all-time high for the last six years in a row, reaching 2.5 million. And the consequences are now trickling down to babies, who are contracting syphilis from their mothers: Congenital syphilis rates nearly quadrupled between 2012 and 2019.”

6th Circ. OKs Ohio Down Syndrome Abortion Law: “The majority of the Sixth Circuit has undone a block on an Ohio law that criminalizes abortion based on a Down syndrome diagnosis, ruling that ‘the right to an abortion before viability is not absolute.’ In a divided Tuesday decision, the appellate court reversed a lower court's preliminary injunction blocking H. B. 124, with the majority saying that the state is allowed to regulate previability abortions so long as those regulations don't put too much of a burden on women who want an abortion.”

2021’s Best & Worst States for Children’s Health Care: FYI. The best is DC. The worst is Texas.

High number of meals consumed in U.S. have low nutritional value: “About 65% of adult meals and 80% of children's meals from restaurants had low nutritional value In 2018, the most recent year for which information is available…” Anyone surprised?

About pharma

US agency says women can get abortion pill via mail: “Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication.
The Food and Drug Administration announced the policy change a day earlier in a letter to the American College of Obstetricians and Gynecologists, one of several medical groups that has sued over the restriction put in place under the Trump administration.”

Rethink specialty pharma benefits: A good, current review of specialty drugs and the methods companies are using to hold down costs.

About health insurance

House passes bill to avert Medicare cuts: “The House on Tuesday approved a bill that would put off automatic cuts to Medicare provider payments until the end of the year.
The bill passed with a strong bipartisan majority of 384-38…
The automatic cuts were originally put into place by the 2011 Budget Control Act, which set up an annual 2 percent reduction in Medicare payments as one of its mechanisms for reducing the debt. Congress has never allowed the cuts to take place, however, voting to overturn them regularly over the past decade.”

Medicaid, CHIP Enrollment Increased After 2 Years of Decline: “Actual data, as opposed to projected data, showed the Medicaid and CHIP combined enrollment from February 2020 to October 2020 reached 7.2 million. Using preliminary data, experts anticipate that in November 2020 that number rose half a million to hit 7.7 million enrollees.”

Today's News and Commentary

About Covid-19

Today’s top story:

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine: “CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. [Emphasis added] This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Studies Confirm Racial, Ethnic Disparities In COVID-19 Hospitalizations And Visits: “Days after declaring racism a serious public health threat, the Centers for Disease Control and Prevention released a pair of studies further quantifying the disproportionate impact of COVID-19 on communities of color. 
The studies, published Monday in Morbidity and Mortality Weekly Report, examine trends in racial and ethnic disparities in hospitalizations and emergency room visits associated with COVID-19 in 2020.”

B.1.1.7 variant more transmissible but does not increase disease severity, two new studies suggest: “Two new studies suggest that the B.1.1.7 coronavirus variant, which was first identified in the United Kingdom, is more transmissible, but the variant does not appear to impact disease severity…
One of the studies, published on Monday in The Lancet Infectious Diseases, found no evidence in a sample of hospitalized patients that the B.1.1.7 variant is associated with severe Covid-19. However, the variant was associated with increased viral load, which supports the growing evidence that it is more easily transmitted.
The other study, also published Monday in The Lancet Public Health, found no statistically significant association between the B.1.1.7 variant and the types or duration of Covid-19 symptoms people said that they experienced.”

Recent Rise in U.S. Covid-19 Cases Driven by Younger People: “In addition to school sports, large outbreaks have been tied to the recent Easter holiday and spring breaks.” Also, this group is the last to be immunized.

About health insurance

HHS approves waiver for Illinois to expand Medicaid postpartum coverage to one year: “The Department of Health and Human Services (HHS) announced it approved a waiver for Illinois to ensure Medicaid eligibility for pregnant and postpartum women for 12 months [from 60 days], the first state to get such a waiver.
HHS Secretary Xavier Becerra said during a press conference Monday that the wavier approval is part of a series of measures the agency is taking to address maternal health outcomes. Becerra also said HHS has made $12 million in funding available for improving rural health maternal outcomes.”

Beneficiaries in Medicare Advantage Receive Better Value and Spend 40% Less than Beneficiaries in Medicare FFS: The study was done by UnitedHealth, but the numbers ring true: “The annual health care spending—on individual premiums and out-of-pocket (OOP) cost sharing for medical, pharmacy, and ancillary services—by a 73 year-old beneficiary of average health in MA ($3,558) is as much as 41% less than for a comparable beneficiary in FFS.”

Fifth Circuit Court Will Not Reconsider Decision Reversing Ruling That Would Have Awarded Nearly $500 Million To States In A Lawsuit Over ACA’s Insurance Provider Fees: Modern Healthcare reports the US Court of Appeals for the Fifth Circuit voted 11-5 to ‘not reconsider its decision to reverse a ruling that would have awarded nearly $500 million to states in a lawsuit over the ACA’s insurance provider fees.’ Modern Healthcare adds, ‘The provision required that states--on behalf of their Medicaid Managed Care Organizations--pay the fee to the federal government,’ but ‘the fee was repealed by Congress in 2021.’”

Rectifying the ACA Family Glitch Could Drive ACA Premiums Down: Approximately 5.1 million individuals are caught in the Affordable Care Act’s ‘family glitch,’ according to a recent Kaiser Family Foundation (KFF) analysis.
Under the Affordable Care Act, an employee may qualify for subsidized marketplace coverage if their employer-sponsored health plan’s premium costs more than 9.83 percent of their household income.
However, only the cost of the individual employee’s coverage is taken into account. Dependents are excluded from the calculation.
Thus, if an employee’s premium falls below 9.83 percent of their household income but the cost of adding their dependents puts them above that threshold, the employee nevertheless would not be eligible for lower-cost Affordable Care Act coverage.”

Data Note: 2021 Medical Loss Ratio Rebates: “The ACA requires health insurers to publicly report the portion of their premium dollars spent on health care costs, quality improvement, and other activities in each state they operate in. MLR rebates are based on a 3-year average, meaning that 2021 rebates will be calculated using insurers’ financial data in 2018, 2019, and 2020. Rebates issued in 2021 will go to consumers who were enrolled in rebate-eligible plans in 2020.
Using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, we find that insurers estimate they will be issuing a total of about $2.1 billion across all markets – the second-largest amount since rebates were first issued in 2012 under the ACA. This year’s rebates are roughly $400 million lower than last year’s record high of $2.5 billion, but more than 50% higher than the amount in 2019 ($1.4 billion, which, at the time, was a record high). These amounts are preliminary estimates, and final rebate data will be available later this year. Some insurers have not yet filed their 2021 rebate estimates.”

About healthcare IT

Supreme Court Ruling May Help Providers With mHealth Messaging Strategies: “The court earlier this month sided with Facebook in a case involving the Telephone Consumer Protection Act (TCPA), ruling that the company didn’t have to adhere to TCPA guidelines because it doesn’t use a messaging system that randomly or sequentially stores or generates a telephone number. In doing so, the court essentially redefined an automatic telephone dialing system, or autodialer.
Writing in the Health Care Law Today blog, attorneys for the Foley & Lardner law firm said the court’s ruling will allow healthcare providers to send out ‘health care messages’ by text without needing prior written consent from patients.”

Optum's 8 biggest health IT acquisitions, investments in the past year: FYI.

31 numbers that show how big Epic, Cerner, Allscripts & Meditech are in healthcare: FYI.
One impressive statistic is that more than 250 million patients have an electronic record in Epic.

Direct-To-Consumer Telemedicine Visits For Acute Respiratory Infections Linked To More Downstream Visits: “Use of direct-to-consumer telemedicine—on-demand virtual care for minor medical issues—is growing rapidly. Although it may yield immediate savings by diverting health care from higher-cost settings, these savings could be countered if direct-to-consumer telemedicine increases follow-up care and, therefore, episode costs. Comparing downstream care utilization data from a large, commercial payer for the period 2016–19, we found that patients with initial visits for acute respiratory infection were more likely to obtain follow-up care within seven days after direct-to-consumer telemedicine visits (10.3 percent) than after in-person visits (5.9 percent)…The telemedicine cohort had fewer (0.5 percent versus 0.6 percent) emergency department visits—a small but statistically significant difference—but more subsequent office, urgent care, and telemedicine visits.”

Use of Online Physician Ratings and Reviews by Older U.S. Adults: Results of a National Survey: “In this nationally representative survey, we found that more than 4 in 10 U.S. adults aged 50 to 80 years have now used online physician rating sites. These sources of information are more likely to be used by women, persons with higher levels of education, and those with a chronic medical condition. Numerous other factors seem to be much more influential among older adults when they select a physician, as suggested by previous research. Yet, online ratings and reviews were perceived to be very important nearly as often as word-of-mouth recommendations from family and friends and more often than where a physician trained or attended medical school.”

About pharma

FDA Revokes Five ANDAs for Generic Opioids: “The companies repeatedly failed to file required annual reports for the ANDAs and to ‘satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS), the agency said.
The drugmakers whose ANDAs were revoked are Lavipharm Laboratories of East Windsor, N.J., Scherer Laboratories, based in Plano, Tex., and Everylife of Seattle, Wash.”

FDA names Patrizia Cavazzoni as permanent director of CDER: “The FDA disclosed Monday that Patrizia Cavazzoni was appointed the permanent director of the agency's Center for Drug Evaluation and Research (CDER). She had been heading the division on an interim basis since last year when Janet Woodcock, currently the FDA's acting commissioner, relinquished the role to help lead an effort to accelerate COVID-19 therapies under Operation Warp Speed.”
The Biden administration has been slow to appoint permanent personnel at the FDA, so this action is an important step.

Biden picks former New Jersey attorney general to lead DEA: “President Biden has selected Anne Milgram, a former state attorney general, prosecutor and longtime advocate for reform of the criminal justice system, to lead the Drug Enforcement Administration, the White House announced on Monday.”

MIT and UCSF researchers create CRISPR 'on-off switch' that controls gene expression without changing DNA: Fascinating technology that could, in some cases, bypass some of the “cutting errors” of CRISPR procedures.
”The gene editing system CRISPR-Cas9 makes breaks in DNA strands that are repaired by cells—a process that can be hard to control, resulting in unwanted genetic changes. Researchers at the Massachusetts Institute of Technology and the University of California, San Francisco (UCSF) designed an alternative technology that changes gene expression without damaging DNA, and they believe it could be useful for both research and drug development.
The researchers used their system, dubbed CRISPRoff and CRISPRon, to induce pluripotent stem cells to transform into neurons. They also used it to silence the gene that makes the protein Tau, which has been implicated in Alzheimer’s disease. They described their research in the journal Cell.”

2021 Global RepTrak 100: Pharma, biotech and life sciences rank 8th among 13 industries. This reputation survey is fascinating. The overall #1 company is LEGO.

Today's News and Commentary

About Covid-19

As vaccinations keep rising, so do Covid-19 hospitalizations among those who aren't vaccinated: “First, the good news: The United States reported a record-high 4.6 million doses of vaccines administered in one day, according to data published Saturday by the Centers for Disease Control and Prevention…
Now the bad news: For the third straight week, new Covid-19 cases and hospitalizations are increasing, according to CDC Director Dr. Rochelle Walenky.”

Nearly half of new US virus infections are in just 5 states: “New York, Michigan, Florida, Pennsylvania and New Jersey together reported 44% of the nation’s new COVID-19 infections, or nearly 197,500 new cases, in the latest available seven-day period, according to state health agency data compiled by Johns Hopkins University. Total U.S. infections during the same week numbered more than 452,000.”
Those states account for 22% of the total US population.

States have been slow to order allotted vaccine doses, spurring calls for new approach: “States have delayed ordering hundreds of thousands of vaccine doses available to them even as coronavirus outbreaks escalate — a sign the nation is moving past its supply pinch and now faces more acute challenges related to demand, staffing and inoculation of hard-to-reach populations…
State and county officials offered different explanations for not ordering their full allocations each week. Many cited the difficulty of matching first and second doses. Others pointed to reduced demand, staffing challenges and inadequate communication between state and local officials.”

AWS [Amazon Web Services] to distribute $12 million in 2021 and expand scope of its initiative to fight COVID-19.: “In the first phase of the initiative, AWS helped 87 organizations in 17 countries ranging from nonprofits and research institutions to startups and large businesses. We have awarded $8 million supporting a range of diagnostic projects, including molecular tests for antibodies, antigens, and nucleic acids; diagnostic imaging; wearables; and data analytics tools that use artificial intelligence and machine learning to detect the virus.
As we launch the next phase, we are excited to broaden the AWS Diagnostic Development Initiative’s scope and distribute the remaining $12 million this year. Starting April 12, we are expanding the scope to three new areas: 1) early disease detection to identify outbreaks at the individual and at the community level; 2) prognosis to better understand disease trajectory; and 3) public health genomics to bolster viral genome sequencing worldwide.”

Japanese drug regulator to fast track any modified vaccines to fight variants: “The Japan Times reported that modified vaccines against new variants of COVID-19 will not require clinical trials in Japan if the production process and handling are similar to those of the original authorised vaccine.
The Pharmaceuticals and Medical Devices Agency (PMDA) said companies will still need to submit data from clinical trials overseas that shows immune response to the variants when they apply for Japanese approval.”
This move is unusual for the VERY cautious PMDA.

Here's how the U.S. compares to other countries on the coronavirus pandemic: A really good review and analysis of the current status of this topic.

South African variant may evade protection from Pfizer vaccine, Israeli study says: “The South African variant, B.1.351, was found to make up about 1% of all the COVID-19 cases across all the people studied, according to the study by Tel Aviv University and Israel’s largest healthcare provider, Clalit.
But among patients who had received two doses of the vaccine, the variant’s prevalence rate was eight times higher than those unvaccinated - 5.4% versus 0.7%.”
The study had very small numbers and the results make no sense. Why would vaccination increase infection almost 8 times more than in those unvaccinated?

Regeneron says antibody cocktail prevented Covid when given as simple injection, not an IV: “The study enrolled 1,500 healthy volunteers, each of whom shared a home with someone who tested positive for SARS-CoV-2, and randomized them to receive a single dose of its antibody treatment, given subcutaneously as four shots, or placebo. After 29 days, 11 patients in the treatment group developed Covid-19 compared to 59 on placebo. And for the subjects who got Covid-19 despite treatment, their symptoms resolved after one week, compared to three weeks for those on placebo. In 204 patients who had already tested positive for the SARS-CoV-2 virus at the study’s outset, the injection reduced their chances of progressing to symptomatic Covid-19 by 31%.”

More Black Americans open to vaccines after outreach efforts: “A poll by The Associated Press-NORC Center for Public Affairs Research in late March found that about 24% of Black American adults said they will probably or definitely not get vaccinated. That’s down from 41% in January. The latest number shows Black Americans leaning against getting shots in almost the same proportion as white Americans at 26% and Hispanic Americans at 22%.
Dr. Georges Benjamin, executive director of the American Public Health Association, said attitudes toward the vaccine among Black Americans have taken “almost a 180-degree turnaround” as outreach campaigns have worked to combat misinformation.
He credited Black physicians, faith leaders and other community organizers for being trusted messengers during the pandemic, which has killed more than 550,000 Americans.”

About healthcare IT

How Americans Feel About Telehealth: One Year Later: A quick-read survey that highlights how much has changed in one year.

In a change, patients can now read the clinical notes written by their physicians: This “spring, new federal rules went into effect that will allow patients to see the clinic notes physicians write, which advocates say will improve patients’ knowledge of their own health….
But not all doctors are as enthusiastic, concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.”

Microsoft accelerates industry cloud strategy for healthcare with the acquisition of Nuance: “Microsoft Corp and Nuance Communications, Inc. today announced they have entered into a definitive agreement under which Microsoft will acquire Nuance for $56.00 per share, implying a 23% premium to the closing price of Nuance on Friday, April 9, in an all-cash transaction valued at $19.7 billion, inclusive of Nuance’s net debt… Mark Benjamin will remain CEO of Nuance, reporting to Scott Guthrie, executive vice president of Cloud & AI at Microsoft. The transaction is intended to close this calendar year….
Nuance’s products include the Dragon Ambient eXperience, Dragon Medical One and PowerScribe One for radiology reporting, all leading clinical speech recognition SaaS offerings built on Microsoft Azure.”

Google is exploring a health record tool for patients: ”After 13 years, Google is coming back for patient health records. The tech giant has launched an early user feedback program aimed at exploring how patients might want to see, organize, and share their own medical record data.
The work could inform the creation of a consumer-facing medical records tool along the lines of Apple’s Health Records app.”
Stand-alone apps are way behind current trends for interoperable systems and data exchange (see recent postings on anti-blocking laws). From the provider standpoint, any system that does not also have a financial (billing/collections) component is worthless.

FDA clears its first plug-in AI video system for spotting polyps during colonoscopy: “The GI Genius, developed by Cosmo Pharmaceuticals and distributed internationally by Medtronic, is designed to be compatible with all agency-approved endoscopy video systems. On the physician’s feed, the add-on system highlights areas of interest, allowing for closer visual inspections, tissue biopsies or ablation, with the goal of finding cancers when they may be easier to treat.”

About healthcare tech

Medline Industries Explores Sale:”Medline Industries Inc. is exploring a sale that could value the big medical-supply company at as much as $30 billion and mark the latest in a recent string of large leveraged-buyout bids.
The family-owned company has hired Goldman Sachs Group Inc. to run the process, according to people familiar with the matter. There is no guarantee the company will ultimately be sold. The process is at an early stage, the people said, with some adding that an IPO or minority investment is also a possibility.”

The top 10 medtech M&A deals of 2020: FYI

About pharma

Ohio Expects To Save $240 Million In Medicaid Drug Costs By Running Its Own PBM: “Ohio officials expect that consolidating the seven private pharmacy benefit managers that run its Medicaid managed-care system into a single, state-regulated PBM will save more than $240 million every year. The change will go in effect starting in early 2022.
Officials will administer PBM services through Gainwell Technologies, a state-regulated PBM that will replace the seven PBMs currently operating in the managed-care system.”

Today's News and Commentary

About Covid-19

In addition to production problems, J&J’s vaccine now has other issues that will decrease its use:

2 health systems pause J&J vaccinations after adverse patient reactions: “Centura Health in Centennial, Colo., said April 7 it temporarily closed a mass vaccination site in Commerce City, Colo., that it runs with the state after 11 people had adverse reactions to Johnson & Johnson's vaccine.
Colorado's public health department said that the 11 people who had adverse reactions at Centura Health's vaccine site experienced symptoms including nausea and dizziness…
UNC Health in Chapel Hill, N.C. said April 8 it paused administering Johnson & Johnson's vaccine after a small number of patients experienced adverse reactions…
According to a statement emailed to Becker's from UNC Health, less than 1 percent of people who have received Johnson & Johnson's vaccine at the health system's clinics have reported lightheadedness or fainting.”
Johnson & Johnson's COVID-19 vaccine under scrutiny at EMA after 4 'serious cases' of unusual blood clots: “So far in the J&J vaccine’s U.S. rollout, EU officials have tracked three cases of unusual blood clots with low blood platelets following vaccination, the European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee said Friday. Another case came in a clinical trial. One of the cases was fatal.”

Blood clot warning added to AstraZeneca's COVID-19 vaccine by EMA: The lead article in this link has a really good graphic showing risks and benefits for the AZ vaccine by age groups. It is clear from this display why many countries are only using this vaccine in those > 60 yrs old.

Hologic inks its largest COVID-powered acquisition yet with $795M for test maker Mobidiag: “After reaping a windfall from COVID-19 diagnostic demand, Hologic’s spending spree continues with its largest acquisition yet: It’s claimed Mobidiag, the Finnish-French molecular test maker, with a $795 million deal.
Hologic saw its diagnostic sales jump 450% over the last quarter alone, built on the back of its high-throughput Panther and Panther Fusion laboratory hardware and coronavirus kits. Now, adding Mobidiag promises to bring in molecular tests for various infectious diseases used at the point of care.”

About health insurance

April 2021 MACPAC Public Meeting: MACPAC met yesterday and today and issued the following reviews and recommendations [click on the pdf tab when you access each site]:

  1. High-Cost Specialty Drugs Review of Draft Chapter and Recommendations

  2. Strategies for State Contracts with Dual Eligible Special Needs Plans

  3. Access to Mental Health Services for Adults: Draft Chapter and Recommendations

  4. Access to Behavioral Health Services for Children and Adolescents: Draft Chapter and Recommendations

  5. Electronic Health Records as a Tool for Integration of Behavioral Health Services

  6. Mandated Report: Non-Emergency Medical Transportation Benefit

  7. Progress on Rebalancing: Lessons from States

  8. Ensuring Medicaid and CHIP Quality

  9. Update on Transformed Medicaid Statistical Information System (T-MSIS)

  10. Panel Discussion: What States are Learning from Expanded Use of Telehealth

CMS selects applicants for opioid use disorder treatment model: Centers for Medicare & Medicaid Services has selected 61 applicants for the Value in Opioid Use Disorder Treatment Demonstration, a four-year Medicare payment model beginning this month for selected health care providers who agree to participate.
Participants will test whether a new care management fee and performance-based incentive payment for OUD treatment services reduces hospitalizations and improves health outcomes for Medicare fee-for-service patients with OUDs, including those dually eligible for Medicaid. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 authorizes $10 million annually in fiscal years 2021-2024 to pay for the treatment services.”

Global and Professional Direct Contracting (GPDC) Model: “The Center for Medicare and Medicaid Innovation (Innovation Center) is excited to announce that 53 Direct Contracting Entities (DCEs) are participating in the first Performance Year (PY2021) of the GPDC Model, which runs from April 1, 2021 through December 31, 2021. A list of all PY2021 participating DCEs (including DCEs continuing participation from the Implementation Period and DCEs beginning participation in PY2021) is available here. The Innovation Center no longer intends to solicit applications from new organizations interested in participating in the GPDC Model beginning on January 1, 2022…
The GPDC Model was previously called the Direct Contracting Model for Global and Professional Options. As part of the Direct Contracting initiative, CMS has also announced the Geographic Direct Contracting Model, which is currently under review.”

 About healthcare IT

Cyberattack exposes 1.2 million California health plan members' data: The California insurer, whose parent company is Centene, is part of a nationwide attack on data transfer file service provider Accellion… 
Breached information may include birthdates, insurance numbers, addresses and more.”

New information-blocking rules: What doctors should know: A good, clear source of information about this topic.

About hospitals and health systems

Healthcare Merger & Acquisition Activity Report: Q1 2021: From KaufmanHall: “One year ago, Q1 2020 was closing with an emerging awareness of the pandemic that was about to occur. The quarter ended with a relatively high number of announced transactions, but with very few large transactions, leaving average seller size by revenue at just $172 million for the quarter. This year, however, as the pandemic seems closer to being contained, the reverse is true. The number of transactions is down in Q1 2021, but the average size of those transactions is significantly larger. Average seller size by revenue is $676 million, which is the third highest quarterly figure for average seller size we have recorded in the past 10 years…”

Today's News and Commentary

About Covid-19

States with the Fewest Coronavirus Restrictions: Iowa continues its top spot on the least restrictive list. The most restrictive is Vermont.

J&J vaccine shortage to hit states next week: This shortage is the result of the manufacturing contamination last week.

About health insurance

More than a half million Americans gain coverage under Biden: “More than a half million Americans have taken advantage of the Biden administration’s special health insurance sign-up window keyed to the COVID-19 pandemic, the government announced Wednesday in anticipation that even more consumers will gain coverage in the coming months.
The reason officials expect sign-ups to keep growing is that millions of people became eligible effective Apr. 1 for pumped-up subsidies toward their premiums under President Joe Biden’s coronavirus relief legislation. The special sign-up opportunity for Affordable Care Act plans will be available until Aug. 15.”

CMS Resumes All Hospital Surveys As COVID-19 Cases Lessen: “The Centers for Medicare & Medicaid Services has announced the immediate resumption of all hospital survey activities, including those related to Medicare compliance and patient safety.
This comes after the agency hit pause on the surveys while hospitals worked to mitigate the COVID-19 crisis.”

CMS proposes boost in pay rates to psychiatric, rehab facilities: 5 details:
“ Inpatient psychiatric facility [IPF] payment rate. CMS is proposing to increase IPF payment rates 2.3 percent over this year in fiscal year 2022.  This would increase total payments to the facilities by about $90 million, the agency said. 

—Inpatient rehabilitation facility [IRF] payment rate. CMS is proposing to increase IRF payment rates by 2.2 percent in fiscal year 2022. CMS estimates this rate increase would increase total payments to the rehab facilities by $160 million.”

About the public’s health

Overdose deaths may have topped 90,000 in 2020: “Commonwealth researchers estimated the year’s total overdose deaths could have exceeded 90,000 — up from 70,630 in 2019. That would be the largest single-year percentage increase in the past two decades.”

About pharma

J&J Commits Up to $780 Million for Flu Drugs, Readies Itself for Next Pandemic: “Johnson & Johnson subsidiary Janssen has agreed to pay up to $780 million for the global rights to Cidara Therapeutics’ Cloudbreak antiviral conjugate (AVC) candidates being developed for preventing and treating seasonal and pandemic influenza.
The collaborative agreement will see Cidara, a San Diego, Calif., biotech, handle the initial development and manufacturing of CD388, its long-acting antiviral immunotherapy candidate, while Janssen will be responsible for late-stage development, manufacturing, regulatory submissions and international commercialization. Janssen will also provide all future funding for the candidate.”

Did pharma overshoot digital sales rep calls? Study charts decline in effectiveness: “Last month, 44% of healthcare professionals said face-to-face sales visits are their preferred option for pharma promotions, according to the latest study from healthcare consultancy ZoomRx.
Even more encouraging for reps is that the face-to-face visits are garnering positive prescription intent—17% higher than before the pandemic began.
However, the bad news is that the opposite is true for digital interactions. Only 24% of doctors now prefer a virtual sales detail. Effectiveness, measured by Zoom Rx as physician likelihood to prescribe after a sales rep encounter, is also waning. It dipped to 50% in March, which is even lower than the pre-pandemic level, when six in 10 HCPs said sales rep meetings had a positive impact on prescribing the detailed product.”

Today's News and Commentary

About Covid-19

Several articles have been published in the past couple days about vaccine passports:
White House rules out involvement in 'vaccine passports': “‘The government is not now, nor will we be supporting a system that requires Americans to carry a credential. There will be no federal vaccinations database and no federal mandate requiring everyone to obtain a single vaccination credential,’ [Press Secretary] Psaki told reporters at a briefing.”
Likely Legal, ‘Vaccine Passports’ Emerge as the Next Coronavirus Divide: “Can businesses require employees or customers to provide proof — digital or otherwise — that they have been vaccinated when the coronavirus vaccine is ostensibly voluntary?
Can schools require that students prove they have been injected with what is still officially an experimental prophylaxis the same way they require long-approved vaccines for measles and polio? And finally, can governments mandate vaccinations — or stand in the way of businesses or educational institutions that demand proof?
Legal experts say the answer to all of these questions is generally yes, though in a society so divided, politicians are already girding for a fight. Government entities like school boards and the Army can require vaccinations for entry, service and travel — practices that flow from a 1905 Supreme Court ruling that said states could require residents to be vaccinated against smallpox or pay a fine.”
Texas governor bans state, some businesses from requiring vaccine passports and
Digital Health Passes in the Age of COVID-19: This article explores the legal, ethical and equity issues of such passes.

CDC distributes $3 billion for vaccine preparedness: “The Centers for Disease Control and Prevention (CDC) is doling out more than $3.1 billion in federal funding under the last round of coronavirus relief legislation to help states and major cities administer vaccinations to their populations.
In press releases to local media, the CDC said it would distribute tens or hundreds of millions of dollars, based on a state’s population, to prepare for mass vaccination campaigns set to begin this month.”

Army-Developed Vaccine Begins Testing: “The U.S. Army will start testing among adult volunteers an Army-developed Covid-19 vaccine that researchers say may protect against a variety of coronavirus variants.
Army doctors planned to start testing on Tuesday the protein-based shot in as many as 72 adults ages 18 to 55 at the Walter Reed Army Institute of Research in Silver Spring, Md., the institute said. The team will test whether the vaccine safely induces the desired immune response in study subjects.
Initial results of the study could become available by midsummer. If the data are positive, the Army likely would try to join with a drug company to further test and develop the vaccine, said Kayvon Modjarrad, director of the institute's emerging infectious-disease branch.”
If the federal government has the capability to produce a vaccine, what took it so long to start?

FDA grants first COVID-19 antibody green light for at-home, fingerprick blood test: “The COVID-19 Self-Collected Antibody Test System, developed by Symbiotica, Inc., is the first home-collected antibody test to receive the FDA’s emergency use authorization, though 75 other antibody tests have been approved for use on samples collected in point-of-care settings. 
Once the test is prescribed, fingerstick blood samples can be taken from individuals as young as 5 years old (with help from an adult for anyone under the age of 18). The sample will be processed for evidence of COVID-19 antibodies at one of Symbiotica’s labs.”

Are youth sports an engine of B.1.1.7 outbreaks?: “Officials say they believe transmission may be happening through athletic activities, rather than in the classroom, because some sports such as wrestling, basketball and volleyball involve close indoor contact. They have also wondered whether outbreaks may be triggered by related interactions such as carpooling, sleepovers and team celebrations, when people let their guard down, rather than from the practices and games themselves.”

Why you can’t compare Covid-19 vaccines: The article provides a YouTube video link to explain what is important in evaluating the vaccines.

6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records: “Among 236 379 patients diagnosed with COVID-19, the estimated incidence of a neurological or psychiatric diagnosis in the following 6 months was 33·62% (95% CI 33·17–34·07), with 12·84% (12·36–13·33) receiving their first such diagnosis.”
The incidences were higher for more severe disease.

Oxford Stops Test Of Vaccine On Youths: “The University of Oxford said it has paused administering doses of the Covid-19 vaccine it developed with Astra-Zeneca PLC in a small U.K. study to test the shot in children and teenagers, pending further information about rare blood-clotting issues in adults who have received it.”

About pharma

MIT team uses machine learning to find nanoparticles with high drug-loading capacities: “Efforts to develop nanoparticle formulations have been held back by the inability to predict which mix of ingredients will have high loading capacities. To address that limitation, MIT researchers used machine learning and high-throughput experimentation to identify effective nanoformulations.”
These formulations can carry therapeutic concentrations of drugs to target sites (like tumors) and may even be able to bypass allergic mechanisms if the patient is allergic to one of the active drug components.

About health insurance

CVS Health affordable housing investments in California surpass $200 million: Just a reminder that insurers are making significant investments into addressing Social Determinants of Disease.

Biden rescinds Medicaid work rules in 2 more states: “CMS sent letters to health officials in Michigan and Wisconsin April 6 withdrawing their approval to implement work requirements for Medicaid beneficiaries. In both letters, CMS noted that combined with the COVID-19 pandemic, the work rules risk ‘significant coverage losses and harm to beneficiaries.’”

2020 AMA prior authorization (PA) physician survey: Keeping in mind that physicians do not like the PA process, below are some of the findings of this just-published survey:

“94% report care delays

79% report that PA can at least sometimes lead to treatment abandonment

While 98% of health plans report they use peer- reviewed evidence-based studies when designing their PA programs, 32% of physicians report that PA criteria are rarely or never evidence-based”
Read the short article for the rest of the opinions.

Today's News and Commentary

About Covid-19

SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments: The latest on this topic from the CDC: “People can be infected with SARS-CoV-2 through contact with surfaces. However, based on available epidemiological data and studies of environmental transmission factors, surface transmission is not the main route by which SARS-CoV-2 spreads, and the risk is considered to be low. The principal mode by which people are infected with SARS-CoV-2 is through exposure to respiratory droplets carrying infectious virus. In most situations, cleaning surfaces using soap or detergent, and not disinfecting, is enough to reduce risk. Disinfection is recommended in indoor community settings where there has been a suspected or confirmed case of COVID-19 within the last 24 hours. The risk of fomite transmission can be reduced by wearing masks consistently and correctly, practicing hand hygiene, cleaning, and taking other measures to maintain healthy facilities.”

Secretary Antony J. Blinken Remarks to the Press on the COVID Response: The only new information in the announcement was the appointment of Gayle Smith to head this country’s global
Covid-19 response. She was the administrator of USAID for President Obama, and served on the National Security Council for both President Obama and President Clinton.

Researchers Are Hatching a Low-Cost Coronavirus Vaccine: A fascinating explanation of the technique for providing a low cost and highly effective Covid-19 vaccine. The article is from The NY Times, so if you cannot access it, try this site for a briefer overview.

About pharma

The top 10 pharma R&D budgets in 2020: “The roughly $70 billion total from the top 10’s budgets combined over the past five years swelled to $96 billion, with almost all seeing boosts in their research budgets (bar Novartis and Sanofi). Back in 2018, for the first time, the top 15 largest pharma companies (by sales) funneled more than $100 billion into research. Three years down the line, and our top 10 have nearly met that number on their own.”
Roche leads the pack with $13.9 billion.

Appropriate Use of Short-Course Antibiotics in Common Infections: Best Practice Advice From the American College of Physicians: Extended use of antibiotics can cause drug resistance. These gildelines for some common bacterial infections generally recommend a 5 day course of therapy with extensions if clinically warranted.

AbbVie drops Humira TV spend; Sanofi and Regeneron, Novo Nordisk step up on March pharma list: “AbbVie’s Humira dropped out of the top spot on the pharma TV ad spenders list in March for the first time in years. Sanofi and Regeneron’s Dupixent took over the No. 1 position, followed by Novo Nordisk’s Rybelsus, leaving Humira in third place, according to data from real-time TV ad tracker iSpot.tv.
Humira’s downward move has been in the works; spending has been declining over the past few months as AbbVie re-directed some of Humira’s advertising budget from the longtime blockbuster to its new generation of immunology products in rheumatoid arthritis Rinvoq and psoriasis med Skyrizi.”

FDA OKs first new ADHD drug in over a decade for children: “The Food and Drug Administration late Friday OK’d Qelbree (KELL’-bree) for treating attention deficit hyperactivity disorder in children ages 6 to 17. It comes as a capsule that’s taken daily. 
Unlike nearly all other ADHD medicines, Qelbree is not a stimulant or a controlled substance, making it harder to abuse than older drugs. That’s been a problem with earlier ADHD treatments like Ritalin, nearly all of which contain the stimulants amphetamine or methylphenidate. 
Qelbree, developed by Supernus Pharmaceuticals of Rockville, Maryland, carries a warning of potential for suicidal thoughts and behavior, which occurred in fewer than 1% of volunteers in studies of the drug.
Supernus wouldn’t disclose the drug’s list price, but it’s sure to be higher than the many cheap generic ADHD pills.”
This drug is one to watch. A great case for appropriate pricing. What if it were the same price as the stimulants on the market? Would it grab a huge share?

Drug prices: the lucrative world of not-so-cheap imitations: Many good examples in this article that highlights the fact that biosimilars only sell for a 10-35% discount from the branded drug, so savings are not as pronounced as with traditional chemical compounds.

Drug companies keep merging. Why that’s bad for consumers and innovation.: “In 1987, the combined market share of the eight largest drug companies stood at a relatively low 36 percent. By the conclusion of the first merger wave, it had grown to 42 percent; by 2012, in the wake of the second merger wave, the ratio had climbed to 53 percent. All told, between 1995 and 2015, the 60 leading pharmaceutical companies merged to only 10.
As a result, now only a handful of manufacturers are responsible for sourcing the vast majority of prescription drugs: Just four companies, for example, produced more than 50 percent of all generic drugs in 2017…
But the newly consolidated pharmaceutical industry actually stifled innovation. In the period following merger waves…, the industry generated fewer new molecular entities each year compared to pre-merger levels. Merged drug companies also spent proportionally less on research than their non-merged competitors.”

The Biden-Harris Administration’s Statement of Drug Policy Priorities for Year One: “The priorities are:

  • Expanding access to evidence-based treatment;

  • Advancing racial equity issues in our approach to drug policy;

  • Enhancing evidence-based harm reduction efforts;

  • Supporting evidence-based prevention efforts to reduce youth substance use;

  • Reducing the supply of illicit substances;

  • Advancing recovery-ready workplaces and expanding the addiction workforce; and

  • Expanding access to recovery support services.”

Cigna's $500 gift to psoriasis patients who switch to Eli Lilly's Taltz is 'rehearsal' for Humira biosimilars: analyst: “Last summer, pharmacy benefits giant Express Scripts tossed Novartis’ psoriasis drug Cosentyx out of its 2021 formulary in favor of Eli Lilly’s lower-cost Taltz. Now Cigna, which owns Express Scripts, is offering $500 to some patients who make the switch—an offer that could set a precedent as the anti-inflammatory market approaches a major biosimilar shakeup, one analyst suggested.
In a letter to doctors in March, some plans run by Cigna Pharmacy said patients could receive a $500 debit card if they switch from Cosentyx to Taltz or an older biologic before Aug. 31 and then refill the prescription before the end of this year. The letter was obtained by the American Journal of Managed Care.
The move comes as biosimilar developers prepare to launch low-cost rivals to another psoriasis remedy that happens to be the world’s best-selling drug—AbbVie’s Humira—in 2023. Bernstein analyst Ronny Gal called Express Scripts' offer to Taltz switchers a ‘general rehearsal for Humira’…”

Startup Raises Cash For Genome System: ““Startup Inscripta Inc. raised $150 million in new venture capital to roll out a genome-editing instrument that could help researchers in healthcare and other industries biologically engineer new products…
Scientists use new gene-editing techniques to make precise changes in the genetic code of organisms to study how genes function, and to genetically program cells or microbes to produce specific proteins, enzymes and other molecules…
Today, Crispr-based genome editing is a manual, labor-intensive process... It frequently requires large numbers of 96-well plates, along with gene-editing reagents, to make changes to the genetic code. Inscripta's system includes an instrument that sits on a lab bench and automates genome editing. Scientists load microbes to be edited and gene-editing reagents into the machine, and edits are made over the next two to four days… 
In addition to the instrument, Inscripta's system includes reagents and software used to make the genome edits and to analyze the results.

About healthcare IT

Verizon jumps into virtual care market with BlueJeans Telehealth: “BlueJeans Telehealth, which launched Monday, was designed from the ground up for healthcare organizations to simplify the virtual experience and offer greater access to care, Verizon executives said in a press release…
The telecommunications giant says its telehealth solution address two key challenges for providers and patients: tech literacy and efficiency.
The BlueJeans platform offers one-click, download-free access to a video telehealth experience via mobile device or desktop to minimize technology complications. The platform also expedites information sharing through a customizable landing experience that includes patient onboarding and education materials, according to the company.”

Characterizing physician EHR use with vendor derived data: a feasibility study and cross-sectional analysis: “For every 8 hours of scheduled patient time, ambulatory physicians spend more than 5 hours on the EHR. Physician gender, specialty, and number of clinical hours practicing are associated with differences in EHR time.”

Is Telehealth The Next Frontier For Net Neutrality Action?: “A recent controversy over whether California's net neutrality law will block a free telehealth app for veterans is calling attention to consumer access problems that still plague the broadband industry, but advocates of the new statute say the law shouldn't pose a threat to the health care app. News reports surfaced in late March suggesting that some
U. S. Department of Veterans Affairs officials were concerned that internet service providers may stop supporting VA Video Connect, an app that provides free telehealth services to veterans and doesn't count against subscribers' mobile data caps.”

About hospitals and health systems

Analysis Suggests Government And Nonprofit Hospitals’ Charity Care Is Not Aligned With Their Favorable Tax Treatment: “Using 2018 Medicare Hospital Cost Reports, we compared charity care provision across 1,024 government, 2,709 nonprofit, and 930 for-profit hospitals. In aggregate, nonprofit hospitals spent $2.3 of every $100 in total expenses incurred on charity care, which was less than government ($4.1) or for-profit ($3.8) hospitals…Using different kinds of analyses, we also found wide variation in charity care provision within ownership types and a lack of a consistent pattern across ownership types. These results suggest that many government and nonprofit hospitals’ charity care provision was not aligned with their charity care obligations arising from their favorable tax treatment.”

Emergency Physicians Recover A Higher Share Of Charges From Out-Of-Network Care Than From In-Network Care: “Physicians collected 65 percent of the charged amount for likely surprise bills compared with 52 percent for other cases. Patients who likely received a surprise out-of-network bill for emergency care paid physicians more than ten times as much as other emergency patients paid, on average.”
The authors focus on high charges for out-of-network bills; however, that practice is only half the story of the difference. In-network contracts require providers not only to adhere to a fee schedule, but prohibit them from balance billing patients beyond agreed-upon copays and coinsurance; no such limits exit with out-of-network care.

About health insurance

Reinventing the Center for Medicare and Medicaid Innovation: An excellent review of the first 10 years of the CMMI and recommendations for its “reinvention” to make it more effective.



Today's News and Commentary

About Covid-19

England pitches free, nationwide COVID-19 testing twice per week: “The plan includes two tests per week starting April 9, with results expected at home within 30 minutes, regardless of whether a person is showing symptoms. The plan is part of the country’s road map to lift wider lockdowns by the end of June, depending on the continuing rollout of vaccines and lower rates of infections and hospitalizations.”

EDVA Seizes Seven Websites Used to Collect Personal Information and Illegally Profit from the COVID-19 Pandemic: “The U.S. Attorney's Office for the Eastern District of Virginia announced today the seizure of seven websites as part of ongoing efforts by Homeland Security Investigations (HSI) to combat online fraud schemes that seek to exploit the increased interest in vaccines, treatments, and employment opportunities associated with the COVID-19 pandemic.
According to court records, the United States obtained court authorization to seize four domains that purported to be the legitimate websites of Pfizer, Inc. (‘Pfizer’)—specifically, ‘pfizermx.com,’ ‘pfizer-vaccines.com,’ ‘pfizerstockrate.com,’ and ‘pfizerksa.com.’ In addition, the government seized three websites claiming to be associated with the United Nations International Children’s Emergency Fund (UNICEF)—specifically, ‘unicefcovid19relief.com,’ ‘unicefeverychild.com,’ and ‘unicefinternship.com.’”

Walgreens Not Following U.S. Guidance on Pfizer Vaccine Spacing: “People are supposed to get two doses, three weeks apart. Walgreens, however, separated them by four weeks because that made it faster and simpler for the company to schedule appointments.”

About healthcare IT

Accelerated antimicrobial discovery via deep generative models and molecular dynamics simulations: “The de novo design of antimicrobial therapeutics involves the exploration of a vast chemical repertoire to find compounds with broad-spectrum potency and low toxicity. Here, we report an efficient computational method for the generation of antimicrobials with desired attributes…Within 48 days, we identified, synthesized and experimentally tested 20 candidate antimicrobial peptides, of which two displayed high potency against diverse Gram-positive and Gram-negative pathogens (including multidrug-resistant Klebsiella pneumoniae) and a low propensity to induce drug resistance in Escherichia coli.”

Mastercard makes healthcare move with digital ID solution patients can use on their smartphones: “In its first major move into healthcare, Mastercard is teaming up with b.well Connected Health to launch a digital solution that enables patients to verify their identity using their mobile phones.
The ID verification service gives patients a simpler and more secure way to prove their identity online and in person when accessing healthcare services. Rather than relying on username and password credentials, the service employs a password-less authentication process through the use of smart biometrics, the companies said in a press release.”

Digital health's red-hot quarter: $6.7B raised in 147 deals: “In the first quarter of 2021, investors doubled down on digital health, pouring $6.7 billion into the sector and making it the most-funded quarter to date, according to investment firm Rock Health.
This year is clearly on track to pass the record-breaking amount of capital raised in 2020 as first-quarter funding approached nearly half of the $14 billion raised through all of last year.”

About diagnostics

Accuracy of Practitioner Estimates of Probability of Diagnosis Before and After Testing: “This survey study suggests that for common diseases and tests, practitioners overestimate the probability of disease before and after testing. Pretest probability was overestimated in all scenarios, whereas adjustment in probability after a positive or negative result varied by test. Widespread overestimates of the probability of disease likely contribute to overdiagnosis and overuse.”
See also, the accompanying editorial.

Global Media Coverage of the Benefits and Harms of Early Detection Tests: “In this study, we examined how innovative early detection tests are covered in the media. The findings are important because of the potential of such tests to harm healthy people, in contrast to tests promoted for investigation of symptoms. Yet coverage emphasized benefits far more than harms, and the risk of overdiagnosis received little coverage. Our findings align with other medical media coverage studies.”
Social media comments were not included in the study.

About hospitals and health systems

The Insanity of U.S. Health Care Pricing: An Early Look at Hospital Price Transparency Data: A good look at how large systems are (not) complying with price transparency regulations. The article also provides examples of how payments for the same service not only vary widely among insurers, but also with the same insurer across different facilities in the same system.

Rep. Miller-Meeks Pushes for Hospital Transparency but Warns of 'Adverse Effects': The point of the article is to emphasize the different ways to report and analyze revealed data. One example of the ‘adverse effects’ in the title is that rural hospitals may not appear to perform as well as other groups and could face shut-down as a result.



Today's News and Commentary

About Covid-19

Fully vaccinated people may travel, CDC says: “But the Centers for Disease Control and Prevention said that even though fully vaccinated individuals are at lower risk of infection, travel is still not recommended due to the rising number of cases in the United States and globally.”

Emergent plant that ruined Johnson & Johnson vaccine doses had prior FDA violations: “In April last year, an investigator from the Food and Drug Administration reported problems he had discovered at a Baltimore plant operated by Emergent BioSolutions, a major supplier of vaccines to the federal government.
Some employees had not been properly trained. Records were not adequately secured. Established testing procedures were not being followed. And a measure intended to “prevent contamination or mix-ups” was found to be deficient.
Soon after the inspection, Emergent’s Baltimore plant was given an important role in Operation Warp Speed, the government’s program to rapidly produce vaccines to fight the coronavirus pandemic. Emergent was awarded $628 million by the government and also secured deals totaling more than $740 million with Johnson & Johnson and AstraZeneca to produce coronavirus vaccines for both companies at the Baltimore site.”

Updated data show 91% efficacy for Pfizer, BioNTech COVID-19 vaccine at six months: “Pfizer and BioNTech on Thursday said updated topline results from a pivotal Phase III study of their COVID-19 vaccine BNT162b2 show it was 91.3% effective at preventing the disease up to six months after the second dose. The new analysis of 46,307 participants in the trial is based on 927 confirmed symptomatic cases of COVID-19 observed through March 13…”
The effectiveness percentage just confirms previous data, but the 6 month duration is great news.

COVID-19 tracker: U.S. may not need AZ vaccine, Fauci says; FDA tweaks Moderna shot authorization: “NIAID Director Dr. Anthony Fauci said the United States may not need the AstraZeneca COVID-19 vaccine because contracts with other suppliers are sufficient to vaccinate the entire population and perhaps provide booster shots in the fall…
The FDA has tweaked its emergency use authorization for Moderna’s COVID-19 vaccine, allowing it to sit longer at room temperatures and for it to be delivered in larger vials.”

State of COVID-19: What you should know about the CDC's 5 variants of concern: A good, concise review of what we know about the variants.

‘Where the magic happens’ — inside BioNTech’s innovative vaccine plant: Why does an mRNA vaccine take so long to produce? “It takes up to 13 days to formulate a batch. The more time-consuming part is testing: each batch needs a few weeks of analysis and quality control.”

About health insurance

Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021: CMS explains how it will recoup the advanced payments it made to providers to keep them fiscally sound.

Billing errors resulted in $23.6M in overpayments to HCA hospital, inspector general finds: “Las Vegas-based Sunrise Hospital and Medical Center, owned by Nashville, Tenn.-based HCA Healthcare, failed to comply with Medicare billing requirements for 54 of 100 inpatient and outpatient claims reviewed by the HHS Office of Inspector General, according to an inspector general's report released March 31.
The billing errors, 50 of which were in inpatient claims and four of which were in outpatient claims, resulted in overpayments of $999,950 for the audit period of January 2017 to December 2018, according to the report.
Based on review of the 100-claim sample, the report estimates that the Las Vegas hospital received overpayments of at least $23.6 million.”

Doctors Accuse UnitedHealthcare of Stifling Competition: “A multistate group of anesthesiologists filed cases in Texas and Colorado, accusing the insurance giant of squeezing them like a ‘boa constrictor.’”
United responded that the group was trying to demand unreasonable rates.
This conflict is very typical of payer-provider reimbursement issues.

New ACA subsidies go into effect as HHS announces $50M boost to outreach funding: “The Department of Health and Human Services (HHS) announced the availability of the lower subsidies, which were passed as part of the American Rescue Plan Act, on Thursday. HHS also announced an additional $50 million for outreach for the latest special enrollment period that ends Aug. 15.”
As previously mentioned, premium support and open re-enrollment just provide access. Out-of-pocket expense help is needed to guarantee affordability.

New Data Show the Highest Prevalence of Medical Liability Premium Increases in 15 Years: From the AMA: “The main and most significant finding in this year's PRP is that more premiums increased than in any year since 2005. The proportion of premiums that went up in 2018 almost doubled in 2019— from 13.7% to 26.5%. Then in 2020, this share grew again, as 31.1% of premiums increased from the previous year. This appears to be the beginning of an upward trend in increases in premiums—a trend not seen in over 20 years.”
Tort reform will not be addressed by Democrats at any level of government because of the significant lawyer-lobby contributions.

MedPAC’s Public Meeting April 1-2, 2021: Check here for its agenda and briefs about what it will recommend to CMS. Among these recommendations are:
1. Streamlining the (too) many alternative payments methods (see the book starting on page 614) and
2. Changing the Medicare Advantage benchmark process (see the book starting on page 299 for an explanation of the MA competitive bidding process).

About pharma

Prescriptions to cost more than £10 in just four years: Obviously a British article, complains about the rising cost of pharmaceuticals. The pound closed today at $1.38.
I hope one day we can make a similar complaint.

Bristol Myers Squibb Settles Medicaid Rebate Suit For $75M: “Bristol Myers Squibb has agreed to pay $75 million to settle a whistleblower's False Claims Act suit over claims it shorted its payments to government insurance programs, Deputy U. S. Attorney Louis Lappen announced from Philadelphia Thursday. The settlement ends claims that Bristol Myers paid less than it owed for dozens of drugs under the Medicaid Drug Rebate Program, where a drugmaker pays states incentives for their Medicaid programs to cover its products, by reducing what it told the state and federal governments the average prices were for the covered drugs.”

About diagnostics

Illumina Agrees To Delay $8B Grail Deal During FTC Challenge: “ Illumina Inc. has agreed to delay closing its planned $8 billion acquisition of cancer detection firm Grail Inc. until as late as September while the Federal Trade Commission challenges the deal in D. C. federal court.”

Today's News and Commentary

About Covid-19

CDC: COVID-19 was third-leading cause of death in U.S. in 2020: From the CDC: “The virus caused nearly 378,000 deaths, or 11%, of the estimated 3.36 million deaths nationally in 2020, the data showed.”

The C.D.C. and N.I.H. launch a rapid, at-home testing initiative in Tennessee and North Carolina: “The program will make rapid at-home antigen tests freely available to every resident of two communities, Pitt County, N.C., and Hamilton County, Tenn., enough for a total of 160,000 people to test themselves for the coronavirus three times a week for a month.”

Large employers are eyeing on-site COVID-19 vaccines, survey shows: “The National Alliance of Healthcare Purchaser Coalitions surveyed 151 employers and other purchasers and found that 80% of very large firms, or those with more than 10,000 employees, anticipate offering vaccines to employees on-site.
While larger companies are considering on-site vaccine clinics, just 8% of those surveyed said they anticipate making COVID-19 vaccines mandatory for workers…”
While getting immunizations into people as quickly as possible is critical, we should think about the tracking and documentation problems with distribution at so many different types of venues.

'More confidence about the results': FDA authorizes two rapid COVID-19 tests for home screening: “Consumers will soon be able to buy rapid COVID-19 tests at chain pharmacies and grocers without a prescription after the Food and Drug Administration on Wednesday authorized two home tests. 
The BinaxNOW COVID-19 self-test will include two tests per kit for serial screening, with the no-prescription test delivering results in 15 minutes which does not require a lab. The FDA also authorized the Quidel QuickVue COVID test that delivers results in 10 minutes and can be used without a prescription.”

‘We can do this’: Biden unveils pro-vaccine TV ads, network of grass-roots leaders to push shots: “The Biden administration on Thursday will unveil its first television advertisements to encourage Americans to get vaccinated against the coronavirus, part of a series of pro-vaccine messages as the White House pushes to achieve the president’s goal of returning the country to some normalcy by July Fourth.
The ‘We Can Do This’ campaign will air across cable and broadcast stations nationwide and include targeted multimillion-dollar ad buys for Black and Spanish-language media.”
Two YouTube videos (English and Spanish with different messages) are in the article.
Think about whether the messages are effective for social marketing. Bob Stevens (my friend and co-author of the text Strategic Marketing for Health Care Organizations) offers the following questions about effectiveness:

“Ad effectiveness can be measured by answering the following questions with primary marketing research data.  

  • What are the specifice ad campaign objectives?

  • What is the competition - not getting a vaccine?

  • Who exactly is the target?

  • What are their levels of vaccine awareness and intent-to-obtain pre and post seeing the ad?

  • The ad and media spending are $10 miilion. We need a positive ROI. How is this measured (e.g, lives saved, health care costs saved, etc.).

Unfortunately, the federal government doesn’t usually take this approach.”

 About pharma 

An Accidental Disclosure Exposes a $1 Billion Tax Fight With Bristol Myers: The full story defies summary…it is a good read that illustrates complex tax laws that affect pharma patents.

AHA [American Hospital Association], ASHP [American Society of Health-System Pharmacists] seek meeting with FDA to address insurer 'white bagging' policies: “Payers use white bagging to dispense drugs to hospitals, requiring these medications come from select network specialty pharmacies. AHA and ASHP said in the letter that doing so circumvents hospital supply chain protocols aimed at patient safety.
The practice also ‘challenges’ the supply chain security issues that are addressed in the 2013 Drug Supply Chain Security Act (DSCSA).”
The corollary, where health plans send these drugs to physician offices is called “brown bagging.”

CVS wants to facilitate 65B healthcare interactions by 2030. Here's how: “CVS Health has set a goal to facilitate 65 billion healthcare interactions over the next decade…
The key strategies? Continuing to grow the reach of its HealthHUB concept stores, taking lessons learned from the pandemic to rethink care delivery and investing in social needs and community health…
Over the course of 2020, CVS became the largest private provider of COVID-19 testing, administering 15 million tests at 4,800 drive-thru sites. The pandemic also drove the healthcare giant to launch E-Clinic, a new telehealth solution for its Minute Clinics, which conducted nearly 20,000 visits.”

About hospitals and health systems

Mayo Clinic raises $500M as it looks to growth: “Mayo Clinic has not designated the bond sale for a specific project, but the system noted it is planning large capital expenditures. Over the next five years, the system expects capital spending of $6.5 billion…”

Some of America’s wealthiest hospital systems ended up even richer, thanks to federal bailouts: The article provides a helpful chart of the grant’s impacts on many large systems.

About healthcare IT

FCC ADOPTS REPORT AND ORDER TO IMPLEMENT ROUND 2 OF COVID-19 TELEHEALTH PROGRAM: The program’s support comes with expense reimbursement, rather than grant funding. The first round was not as successful as expected, so it has been modified for a second round. For example, applicants will be rated focusing on those in hardest-hit and low-income areas, those with provider shortages and Tribal communities.

Scalpel, tongs . . . WiFi? The rise of virtual surgery: Fascinating look at remote surgery.

About health insurance

Millions Could Lose Out on Mammograms, Cancer Screenings Because of ‘Incredibly Concerning’ Lawsuit: “With a challenge to the Affordable Care Act still pending at the Supreme Court, conservatives are continuing to launch legal attacks on the law, including a case in which a Texas federal judge seems open to ending the requirement that most Americans must receive preventive services like mammograms free of charge.
Businesses and individuals challenging the ACA’s first-dollar coverage mandate for preventive services have legal standing and legitimate constitutional and statutory grounds to proceed with their lawsuit to overturn it, U.S. District Judge Reed O’Connor ruled late last month in Fort Worth. O’Connor, who previously found the entire ACA to be unconstitutional, denied most of the federal government’s motion to dismiss the case, Kelley v. Azar.
The plaintiffs cite religious and free-market objections to the ACA requirement in their class action suit against the government seeking to halt enforcement of the requirement.”
This change would be a huge blow to public health, particularly in light of this Gallup Poll published yesterday: In U.S., An Estimated 46 Million Cannot Afford Needed Care

Biden infrastructure package includes $400B to expand Medicaid home services: “President Joe Biden is expected to include $400 billion for expanding Medicaid beneficiaries' access to home- and community-based care for seniors and the disabled as part of a larger infrastructure package.”

Today's News and Commentary

About Covid-19

Pfizer says its COVID-19 vaccine is 100% effective in children ages 12-15: “In a placebo-controlled trial of 2,260 adolescents, none of the participants who received the real vaccine developed COVID-19, the companies said.
Eighteen adolescents who received placebo, or fake, doses became infected with the virus, they said.”
The numbers are still small but consistent with the robust immune responses in younger persons.

Coronavirus: Nations call for independent probe into virus origin: “A group of 14 countries including the US, UK, Japan, Canada and Australia issued a joint statement on Tuesday that expressed “shared concerns” over the World Health Organization’s study on the origins of the coronavirus outbreak and called for an independent probe
The countries voiced concerns that the ‘international expert study on the source of the Sars-Cov-2 virus was significantly delayed and lacked access to complete, original data and samples.’”
WHO site visitors insist their Chinese hosts were transparent and forthcoming, but other nations are not convinced.

Johnson & Johnson COVID- 19 Vaccine Manufacturing Error Affects 15 Million Doses:”Amanufacturing error at a plant involved in COVID-19 vaccine production affected 15 million doses worth of an ingredient for Johnson & Johnson’s vaccine, according to two sources familiar with the matter, but the company downplayed the situation and said it met its most recent vaccine delivery target…
“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process, J&J said.”

CDC director says data 'suggests that vaccinated people do not carry the virus': “CDC director Rochelle Walensky said data suggests fully vaccinated people don't carry COVID-19.” However, Two-thirds of epidemiologists warn mutations could render current COVID vaccines ineffective in a year or less

Justice Department Takes Action Against COVID-19 Fraud-Historic level of enforcement action during national health emergency continues: “As of [Friday], the Department of Justice has publicly charged 474 defendants with criminal offenses based on fraud schemes connected to the COVID-19 pandemic. These cases involve attempts to obtain over $569 million from the U.S. government and unsuspecting individuals through fraud and have been brought in 56 federal districts around the country. These cases reflect a degree of reach, coordination, and expertise that is critical for enforcement efforts against COVID-19 related fraud to have a meaningful impact and is also emblematic of the Justice Department’s response to criminal wrongdoing.”
Each new crisis creates new opportunities to commit fraud.

Humanigen's COVID-19 phase 3 hits goal, sending stock soaring: “A phase 3 clinical trial of Humanigen’s lenzilumab in hospitalized COVID-19 patients has met its primary endpoint. Humanigen plans to use the data to seek emergency use authorization from the FDA. 
Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline have predicted that they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.”

COVID-19's fourth wave is hitting the US hard: “The United States has reported an average of 65,000 new cases in the last seven days, according to data from the Centers for Disease Control and Prevention (CDC), up about 10,000 cases per day since the most recent nadir two weeks ago.
Those figures are well below the January apex of the third wave of infections, when a quarter-million people a day were testing positive for the virus.”

Covid Vaccine Hesitancy Drops Among All Americans, New Survey Shows: “A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.
About 55% of Black adults said they had been vaccinated or plan to be soon, up 14 percentage points from February, according to a poll released Tuesday by KFF. The rate now approaches that of Hispanics, at 61%, and whites at 64%. (Asian Americans were not polled in sufficient numbers to compare their responses with other racial and ethnic groups.)
But the poll found that 13% of respondents overall said they will ‘definitely not’ be vaccinated, signaling that significant hurdles remain in the nation’s vaccination campaign. (KHN is the editorially independent newsroom of KFF, an endowed nonprofit organization providing national information on health issues.)
Among all groups, Republicans and white evangelical Christians were the most likely to say they will not get vaccinated, with almost 30% of each group saying they will ‘definitely not’ get a shot.”

T cells induced by COVID-19 infection respond to new virus variants -U.S. study: “‘Our data, as well as the results from other groups, shows that the T cell response to COVID-19 in individuals infected with the initial viral variants appears to fully recognize the major new variants identified in the UK, South Africa and Brazil,” said Andrew Redd of the NIAID and Johns Hopkins University School of Medicine who led the study.”

Germany suspends use of AstraZeneca’s Covid shot for the under-60s, dealing another blow to drugmaker: “Germany has suspended use of the coronavirus vaccine created by AstraZeneca and the University of Oxford in the under-60s, due to renewed concerns over reports of blood clots.” And in a related story: Amid rollout imbroglio, AstraZeneca's COVID vaccine has at least one fresh start: A new brand name: “AstraZeneca’s COVID-19 vaccine has an official name, Vaxzevria, now approved in Europe. But is a new name enough to hurdle its rollout communication glitches and now wavering vaccine confidence?”

Digital papers, please? New York becomes first state to roll out IBM's digital COVID-19 vaccine passport: IBM and New York state launched the Excelsior Pass. “Built on the tech giant’s Digital Health Pass platform, it combines a smartphone wallet app for individual use and a scanner app for businesses. The official launch comes after two pilot programs and a beta test proved its efficacy.”
Debates about HIPAA compliance fall on the side of this types of proof card does not violates theses laws.

White House weighs temporarily lifting intellectual property shield on Covid-19 vaccines: “The White House is weighing whether to suspend intellectual property protections for Covid-19 vaccines and treatments, in response to pressure from developing nations and subsequent support from progressive lawmakers, according to three sources familiar with the matter.
A temporary suspension of intellectual property protections would apply to all medical technologies to treat or prevent Covid-19. South Africa and India made a formal request to the World Trade Organization to waive the protections until the pandemic is over, but the issue was tabled without a resolution.”
Mentioned in previous blogs, the concept is called a “compulsory license” or “walk in” rights.

About health insurance

CMS to pause Medicare payments until Congress passes sequester fix next month: “The Biden administration is temporarily holding Medicare claims with service dates on or after April 1 to ensure providers aren't impacted by a 2% cut to payments set to go back into effect on that date…
The agency also notified Medicare Advantage and Part D plans that ‘CMS will resume standard sequestration reductions beginning with April 2021 payment for Medicare Advantage organizations and Prat D sponsors.’”

Epic, Humana ramp up partnership to focus on streamlining prior authorizations: “In this next phase of the collaboration, EHR vendor Epic and Humana will connect their software to manage prior authorizations electronically and make Humana member information available to providers at the point of care, the companies said.”
It is amazing that something so needed took so long to be recognized and developed.

As Medicare Advantage Enrollment Booms, Healthcare Entities Need to Plan Around Key Trends: Chartis’ 2021 Medicare Advantage Competitive Enrollment Report. Among the findings:

  • “Medicare Advantage grew 9.6 percent this year, while enrollment in Original Medicare fell 2.6 percent, pushing Medicare Advantage penetration to 42 percent[up from 32% five years ago],

  • For-profit plan growth continues to outpace Blue and non-profit plans. For-profit plans now account for 71 percent of all enrollees, up from 69 percent last year.

  • Among for-profit plans, UnitedHealthcare and Centene saw the greatest gains, adding 1.6 million lives between the two, and pushing their combined share up 4 points.”

  • The article also ranks top MA plans based on enrollment (United is #1)

Medicare Advantage beneficiaries save more money on out-of-pocket costs than Medicare fee-for-service: This research shows why the popularity of these plans continues to grow. “Beneficiaries in MA reported out-of-pocket and premium spending of $3,354 a year in 2018, compared with $4,994 in fee-for-service, the analysis added. That was a $42 increase since 2017.”

Here are the payment models the Biden administration has pulled for review or delayed: A good review of this topic.

DOJ taking a closer look at Optum-Change deal amid antitrust concerns: “The Department of Justice (DOJ) is digging further into UnitedHealth Group's planned $13 billion acquisition of Change Healthcare…The deal was first announced in January, with UnitedHealth saying it would purchase the revenue management company for $7.84 billion in cash and $5 billion in debt. The healthcare giant intends to fold it into its Optum subsidiary.”

About healthcare IT

Digital health's top 10 money raisers in 2021—so far: FYI

Why experts say the information blocking ban will be game changing for patients: “Starting next week, a new regulation goes into effect that will give patients easier access to their digital health records through their smartphones.”

Assessment of Diagnosis and Triage in Validated Case Vignettes Among Nonphysicians Before and After Internet Search
: “Results of this study suggest that, contrary to concerns of its harmfulness, an internet search was associated with modest improvements in diagnosis but had no association with triage.”

About pharma

Pumped by a big year for its flu shots, Sanofi lays out €600M for new vaccine manufacturing plant: “The French drugmaker plans to splash out €600 million to build a new flu vaccine factory in Toronto to increase supply of its Fluzone High-Dose vaccine. The plant will turn out the vaccine, which contains four times more antigen than standard-dose vaccines, for Canada, the U.S. and Europe.”
In the current and post-Covid-19 eras, vaccines are recognized as valuable (and profitable) products.

Characteristics of Copayment Offsets for Prescription Drugs in the United States: Offsets are “coupons, vouchers, and other types of copayment… that reduce patients’ out-of-pocket drug spending...
In this analysis of patient-level pharmacy claims from 2017 to 2019, approximately half of all offsets involved pharmacy-PBM contractual arrangements, and half were offered by manufacturers. All offsets were associated with a significant reduction in patients’ out-of-pocket costs, were highly concentrated among a few drugs, and were generally not more generous among individuals in counties with lower income or larger Black or uninsured populations.”

The top 20 pharma companies by 2020 revenue: FYI

Novartis Can Provide CAR-T Therapy for Free, OIG Says: “HHS’ Office of Inspector General (OIG) said Novartis is free to pay for low-income patients to receive its pricey CAR-T therapy Kymriah (tisagenlecleucel), and those payments will not be considered illegal.
OIG told Novartis that while payments for the $475,000 one-time gene therapy could in theory compel doctors or treatment centers to use the treatment or influence patients to choose it, patients are able to get the drug at many different healthcare centers so they would be unlikely to accept the payment simply to get the drug at one specific place or from one specific doctor.”
The issue here is illegal inducement.

About the public’s health

Births: Final Data for 2019: Yes, this data is the latest published and has a wealth of information.
”A total of 3,747,540 births were registered in the United States in 2019, down 1% from 2018. The general fertility rate declined from 2018 to 58.3 births per 1,000 women aged 15–44 in 2019. The birth rate for females aged 15–19 fell 4% between 2018 and 2019. Birth rates declined for women aged 20–34 and increased for women aged 35–44 for 2018–2019. The total fertility rate declined to 1,706.0 births per 1,000 women in 2019. Birth rates declined for both married and unmarried women from 2018 to 2019.”

Declines in Prevalence of Human Papillomavirus Vaccine-Type Infection Among Females after Introduction of Vaccine — United States, 2003–2018: Latest report on this subject form the CDC. “Nationally representative data through 2018 indicate that HPV vaccine-type prevalence continues to decline among females aged 14–19 (88%) and 20–24 (81%) years compared with before vaccination. The findings also show evidence of indirect protection of unvaccinated females through herd effects in these age groups.”

2021's Most & Least Stressed States: Topping the list of most stressed is Nevada. Least stressed is South Dakota. Check the rankings for further states.

Secondhand Smoke Is Sending Kids to the ER: “Compared to other kids, those exposed to secondhand smoke were more likely to have had an urgent care visit over a one-year period, and to incur higher costs for such visits. They also were nearly twice as likely to be admitted to the hospital.”
Do we need yet another reason to ban smoking?

Black Patients Are More Likely Than White Patients to Be in Hospitals with Worse Patient Safety Conditions: “Black patients experienced higher rates of adverse patient safety events on 6 of 11 patient safety measures, including 5 of 7 surgery-related patient safety measures. For 9 of 11 patient safety indicators, including 6 of 7 surgery-related patient safety indicators, Black patients were significantly less likely to be admitted into hospitals classified as “high quality” (i.e., hospitals best at minimizing patient safety risks based on the median value of each patient safety indicator). These findings suggest that current policies aimed at reducing adverse patient safety events have been ineffective in addressing inequities in the quality of inpatient care. “
The question now is why black patients need to go to those hospitals. Obviously, proximity is a major factor. This research would make a great discussion topic to root out the “why’s” and offer solutions.

About healthcare professionals

US News published its latest grad school report, including medicine, nursing, pharmacy, public health and health administration: FYI


Today's News and Commentary

About Covid-19

More than 40 states say they will meet or beat Biden’s May 1 deadline for vaccine eligibility for all adults: The headline is the story.

AZD1222 US Phase III primary analysis confirms safety and efficacy: After the past couple days’ criticisms about data problems, Astra Zeneca reported its vaccine’s corrected stats:
“76% vaccine efficacy against symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

85% efficacy against symptomatic COVID-19 in participants aged 65 years and over”

India detects several variants including a new double mutant strain: The headline is the story. But the good news may be:
The Coronavirus Variants Don't Seem to Be Highly Variable So Far: “SARS-CoV-2 may be settling into a limited set of mutations.” The article discusses the concept of convergent evolution to explain this phenomenon.

Global COVID-19 cases rise for 4th straight week:”In its latest weekly snapshot of global COVID-19 activity, the World Health Organization (WHO) said yesterday that cases rose for the fourth week in a row, led by cases in the Americas and Europe, with deaths now leveling off after a 6-week drop.
Though much of the rise was spread across four of the WHO's regions, rises were especially steep in certain countries, such as India, where cases were up by 35% over the previous week.”

Carcinogen Found in Hand Sanitizers That Plugged Covid Gap: “An assortment of hand cleaners that flooded into the market after mainstays disappeared from retail outlets contain high levels of benzene, according to Valisure, a New Haven, Connecticut-based online pharmacy that tests products for quality and consistency.” See the article for a list of these products.

'I don’t want to be the one who gives it to people': Many Americans won't eat out, fly until COVID-19 herd immunity arrives: “A growing share of Americans would feel safe resuming activities like  dining out or flying within a few weeks of their second dose of COVID-19 vaccine, but 25% to 30% would wait until the nation reaches herd immunity, according to a Harris Poll survey for USA TODAY.
Their attitudes bode well for what’s expected to be a historically robust recovery from the coronavirus recession. But the sizeable share of people who prefer to wait until at least 70% of the population is immune could mean a less roaring launch to the rebound as some activity shifts to late summer and fall from midyear.”

Krispy Kreme’s ‘sweet’ vaccine promotion leads to bitter Twitter war: I won’t give away the details of the story…but this article is a great social/cause marketing case study.

Thermo Fisher deploys sensors for detecting airborne COVID-19: “The company said its AerosolSense Sampler is designed to help hospitals, nursing homes, schools, offices and other locations surveil high-traffic areas for elevated levels of the pathogen, providing an early-warning layer of screening that can be combined with individual diagnostic tests after the pandemic begins to subside.
The toaster oven-sized machine collects aerosol samples and traps any pathogens on a removable cartridge—with the ability to completely filter the air of a 1,000-square-foot room in under 20 hours—which is then analyzed in a laboratory using Thermo Fisher’s established TaqPath COVID-19 molecular test kit.”

About pharma

Opioid Industry Documents Archive: Just placed online from UCSF and Johns Hopkins University: “The archive contains emails, memos, presentations, sales reports, budgets, audit reports, Drug Enforcement Administration briefings, meeting agendas and minutes, expert witness reports, and depositions of drug company executives. The archive serves as a living repository of information that can be used to learn from the opioid epidemic so as to improve and safeguard public policy and public health, and to ensure that the opioid-related harms that have taken place never occur again.”

The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research: “The broad goal of the Tuskegee Legacy Project (TLP) study was to address, and understand, a range of issues related to the recruitment and retention of Blacks and other minorities in biomedical research studies. The specific aim of this analysis was to compare the self-reported willingness of Blacks, Hispanics, and Whites to participate as research subjects in biomedical studies, as measured by the Likelihood of Participation (LOP) Scale and the Guinea Pig Fear Factor (GPFF) Scale….The findings revealed no difference in self-reported willingness to participate in biomedical research, as measured by the LOP Scale, between Blacks, Hispanics, and Whites, despite Blacks being 1.8 times as likely as Whites to have a higher fear of participation in biomedical research on the GPFF Scale.”

CVS launches new mental health initiative: “In an effort to simultaneously alleviate the strain on providers and expand access to mental health resources, CVS is adding virtual and in-person behavioral healthcare offerings in select HealthHUB locations.”
This step is not only an expansion of services, it is a departure from “quick care” models in retail outlets.

FDA slaps new warning on GlaxoSmithKline's Shingrix based on post-marketing findings: “Wednesday, the FDA alerted the public that it has added to the ‘warnings and precautions’ section of the shingles vaccine’s label language about an increased risk for a rare neuro autoimmune disorder called Guillain-Barré Syndrome (GBS). [Antibodies attack peripheral nerves.]
The update came after a post-marketing observational study by federal health agencies noted the risk during the 42 days following vaccination with Shingrix. The FDA stressed that ‘available evidence is insufficient to establish a causal relationship,’ and that the ‘benefits of vaccination with Shingrix continue to outweigh its risks.’”

About hospitals and health systems

National Hospital Flash Report Summary: March 2021: From Kaufman Hall and the AHA: “Operating Margin fell 30.8% (3 percentage points) from February 2020 to February 2021 without the federal aid, while Operating EBITDA Margin was down 22.6% (3.2 percentage points). With CARES, Operating Margin fell 23.4% (2.6 percentage points) and Operating EBITDA Margin fell 18.3% (2.4 percentage points) year-over-year (YOY). Looking at year-to-date (YTD) results, Operating Margin declined 48.0% (4.2 percentage points) without CARES and 36.0% (3.3 percentage points) with CARES.”
But not all facilities and systems are losing money: Advocate Aurora posts $558M in earnings in 2020, down from $1.4B in 2019: The not-for-profit, 26-hospital system said in its latest earnings report, posted Monday, that it generated $13.1 billion in total revenue for 2020, up 2.6% from 2019. Advocate Aurora is the latest hospital system to end 2020 in the black.”

About healthcare IT

Most pediatricians believe telehealth is here to stay: “An independent study commissioned by a pediatric virtual care company found that 92% of pediatricians and clinicians believe that telemedicine will remain part of health practices in the future.  
Virtually all of the 787 pediatricians and clinicians who responded to an online survey reported currently using a telemedicine platform, with 96% saying they offered telemedicine during regular business hours.”

About the public’s health 

Dr. Rachel Levine makes transgender history in confirmation as assistant secretary of HHS: The headline is the story.

About health insurance

Avoid these 8 types of health insurance, 30 patient organizations say: Great advice!
”Here are the eight health plans the coalition highlighted and asked lawmakers to review:

  • Short-term, limited-duration insurance

  • Healthcare sharing ministries

  • Farm bureau plans

  • Grandfathered plans

  • Multiple employer welfare arrangements and association health plans

  • Spurious single-employer self-insured group health plans

  • Minimum essential coverage-only plans

  • Excepted benefit plans

Read more here.”



Today's News and Commentary

About health care providers

DaVita, Fresenius team up to bring dialysis care out of their clinics and into the home: “DaVita Kidney Care will expand its use of home hemodialysis machines supplied by Fresenius Medical Care—including the smaller, portable and digitally connected devices Fresenius picked up in early 2019 through its long-awaited $1.9 billion acquisition deal for NxStage Medical.
The agreement will also grant DaVita patients access to Nx2me Connected Health, a platform that collects and shares individual treatment information with clinics and care teams—while the entire system will allow some to perform hemodialysis solo, or even while the patient and their care partner are asleep.”
What is interesting about this story is competitors are teaming up to accelerate a trend taking patients out of their facilities and into home treatment.

About the public’s health

Newly confirmed surgeon general to focus on COVID, opioids: “The Senate confirmed a soft-spoken physician as President Joe Biden’s surgeon general Tuesday. While Dr. Vivek Murthy says ending the coronavirus pandemic is his top priority, he’s also raised concerns over a relapsing opioid overdose crisis.”

About health insurance

CMS withdraws 3 proposed health rules: “The withdrawn rules include a revision to Medicare Part A enrollment requirements, altered dialysis coverage requirements for third party-payment programs and increased oversight of accrediting organizations.” For a full list and description of the executive orders under review, go to: Office of Information and Regulatory Affairs (OIRA) Executive Order Submissions Under Review.

Anthem to buy home nursing management company: The management company “MyNexus currently provides clinical support services to 1.7 million Medicare Advantage members across 20 states.”
Such diversification by an insurance company is very unusual.

Evaluation of Hospital Cesarean Delivery–Related Profits and Rates in the United States: “In this cross-sectional study of US nationally representative hospital discharge data, hospitals with higher profits per cesarean procedure were associated with an increased probability of delivering newborns through cesarean birth.”
Do we still need studies showing that how you pay will influence the type and volume of services provided? This fact has been known for decades in healthcare.

Obamacare enrollment period extended beyond May as new insurance subsidies kick in: ”The Biden administration is extending for three more months a special opportunity for people to sign up for government-subsidized health insurance through the federally run marketplace.
Instead of ending May 15, the special enrollment period will run through Aug. 15 to give people more time to take advantage of the expanded subsidies included in the recently passed $1.9 trillion stimulus package.”

About Covid-19

Association of Age With SARS-CoV-2 Antibody Response: “The results of this study suggest that SARS-CoV-2 viral specific antibody response profiles are distinct in different age groups. Age-targeted strategies for disease screening and management as well as vaccine development may be warranted.”
Particularly, as expected, children had much higher antibody responses than adults.