Today's News and Commentary

About Covid-19

Why Do COVID-19 Death Rates Differ Wildly from Place to Place?: “…a country’s level of pre-COVID income inequality was by far the best predictor of the COVID death rate. The same finding emerged when the researchers studied variations in COVID death rates across U.S. states: higher death rates tend to occur is U.S. states with higher pre-COVID income inequality…”
The “death rate among low-income Americans would have been a staggering 30 percent lower if this group had the same COVID case-fatality rate as high-income people. The researchers surmise that lower-income people presumably came into the pandemic with more preexisting health conditions that made them much more predisposed to succumb to the virus than those with more money.”

Trump’s vaccine tsar launches European biotech roll-up: “Moncef Slaoui, the former GlaxoSmithKline research boss who became the Trump administration’s vaccine tsar, is returning to the private sector at a new venture that is rolling up smaller biotech companies in an attempt to take on Big Pharma…
Slaoui is also a partner at Medixci, which will roll its stakes in the merged companies into a shareholding in Centessa. The new umbrella company includes drug development programmes ranging from cancer to blood pressure. It has four products in clinical trials, including a drug for kidney disease in a phase 3 study and a cancer drug in phase 2/3.”

White House says it will send 13.5 million vaccine doses a week to U.S. states: “The White House said on Tuesday it is increasing the supply of coronavirus vaccines sent each week to states to 13.5 million doses, and is also doubling the amount shipped to pharmacies to 2 million doses this week.”

Thousands of the world’s most trusted brands—including Pepsi, Starbucks, Comcast, Verizon, Marriott, and even the CDC—have funded COVID-19 misinformation, including Chinese and Russian propaganda websites: The headline speaks for itself. How can companies screen their outlets to avoid these problems?

Saliva Test May Predict Severity of COVID-19: “‘We discovered that the saliva viral load is a much better correlate of disease outcome than the nasopharyngeal viral load,’ says Akiko Iwasaki, PhD, lead author of the study, and an immunologist at Yale School of Medicine…
’The saliva viral load correlates not only with the disease severity, but also with the immune response to COVID-19, and older age, [male] sex, and co-morbidities that have been found to put people at higher risk—essentially every parameter that we've examined,’ Iwasaki says.”

North Korea accused of hacking Pfizer for Covid-19 vaccine data: “North Korea attempted to steal Covid-19 vaccine technology from US pharmaceutical company Pfizer, according to South Korean intelligence officials. 
It is currently unclear as to what, if any, data was stolen.”

Moderna Provides U.S. COVID-19 Vaccine Supply Update: “Moderna expects to deliver 100 million doses to the U.S. Government by end of March 2021.
Moderna expects to deliver 100 million additional doses by end of May 2021 followed by another 100 million additional doses by end of July 2021.”

Fauci more cautious on COVID-19 vaccine rollout, pushing ‘open season’ to late May or June: “‘We were expecting a greater number of doses from Johnson & Johnson, and it looks like, even though it’s a good vaccine, that we’re not going to have a substantial amount of doses until we get into April and May,’ he said…”

FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls:analyst: “It was bad enough when a study released last week concluded that AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive B.1.351 variant that recently emerged in South Africa. Now, analysts are wondering whether inconsistent manufacturing of the vaccine for the clinical trials may have muddied the results—concerns that could give the FDA pause when considering the vaccine for emergency use.
That was the conclusion of a note SVB Leerink analysts sent to clients Wednesday, in which they laid out both the bear and bull cases for FDA authorization of AstraZeneca’s COVID vaccine. The bottom line? The bear case is worrisome, they said.”

Key things to know about Biden's agenda to battle Covid-19: A good summary of this issue, including last night’s CNN town hall meeting.

About healthcare IT

Humana to pilot new tech-enabled chronic care management platform: “Humana is launching a pilot for a new, tech-enabled chronic care management platform.
Humana Care Support will harness enhanced data analytics to create an integrated, personalized experience for members, the company said in an announcement provided first to Fierce Healthcare.
The program will also offer members with chronic illnesses access to a multidisciplinary care team to address their individual needs. The team includes a nurse, a pharmacist, a social worker and a behavioral health expert, Humana said.
The model is designed to integrate the social determinants of health and value-based care into its personalized approach, according to the announcement.”

FDA Selects First Head of Medical Device Cybersecurity:”The FDA’s Center for Devices and Radiological Health has appointed Kevin Fu as acting director of its newly created medical device cybersecurity division.
A prominent medical device security researcher at the University of Michigan, Fu has trained hundreds of engineers at medical device companies in cybersecurity engineering.”

About pharma

AbbVie, Novo Nordisk lead pharma TV advertisers into big-spending January: “Pharma marketers are continuing their TV ad push into 2021. January pharma TV spending picked up where December ended—matching branded ad spending among the top 10 almost dollar for dollar.
The highest spenders racked up $216 million for the month after a robust $217 million December, according to data from real-time TV ad tracker iSpot.tv.”
How does all that spending really translate into sales?

McKinsey's Opioid Woes Far From Over Despite $600M Deals: “Plaintiffs lawyers who spearheaded opioid litigation against pharmaceutical companies are opening a new front against McKinsey & Co. on behalf of local governments, indicating that the consulting giant's settlements worth $600 million with nearly every state won't end its legal troubles. One sign of the emerging onslaught played out during a Tuesday court hearing over New York Attorney General Letitia James' requested approval of a $32 million settlement for the Empire State. The tentative settlement is among more than 50 deals with states and territories that McKinsey announced earlier this month…”

Bristol Myers, Sanofi To Appeal $834M Hawaii Order On Plavix: The headline speaks for itself. See previous blog for the story.

An mRNA vaccine delivered in hydrogel shows promise as a durable cancer immunotherapy: “…scientists at China’s National Center for Nanoscience and Technology (NCNST) have designed a hydrogel to deliver an mRNA vaccine with an immune-stimulating adjuvant. When injected into mice with melanoma, the vaccine stayed active for at least 30 days, inhibiting tumor growth and preventing metastasis, according to results published in the American Chemical Society journal Nano Letters.
The results showed that the hydrogel delivery system holds potential for helping mRNA vaccines achieve long-lasting anti-tumor effects as cancer immunotherapy, the researchers said.”

As Drug Prices Keep Rising, State Lawmakers Propose Tough New Bills to Curb Them: A good summary of some state efforts to lower pharma costs.

About the public’s health

Recommended Childhood and Adolescent Immunization Schedule: United States, 2021: Open access statement from the American Academy of Pediatrics.

A comparative analysis of premature heart disease- and cancer-related mortality in women in the USA, 1999–2018: “The mortality gap between cancer and heart disease is decreasing among women <65 years. Intensive cardiovascular health interventions are required focusing on vulnerable young demographic subgroups and underserved regional areas to meet the American Heart Association’s Impact Goal and Million Hearts Initiative.”

Today's News and Commentary

Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic: “America's top infectious disease official Dr. Anthony Fauci received a prestigious $1 million Israeli prize Monday, along with six other researchers who shared two additional $1 million prizes for their contributions to health and medicine.
The Dan David Prize, affiliated with Tel Aviv University, said it honored Fauci for his career in public health and ‘speaking truth to power’ during the politicized COVID-19 crisis.”

About COVID-19

AstraZeneca's COVID-19 vaccine to be trialed in young people for first time: “AstraZeneca's COVID-19 vaccine development partner has announced that it will launch the first study to evaluate safety and immune responses of the AZD1222 candidate in children and adolescents aged six to 17 years. According to the University of Oxford, the new study would build on previous trials of the vaccine that have shown it produces ‘strong immune system responses and has high efficacy in all adults’…
The Phase II trial will recruit 300 paediatric volunteers, with up to 240 receiving AZD1222, while the remainder will be administered a control meningitis vaccine.”

Covid vaccine: Elderly show fewer post-vaccine symptoms than young: Study: “Elderly people in India have reacted with fewer symptoms after receiving the COVID-19 vaccine, compared to people in the age group from 20 to 40, reported The Economic Times…
The news source said women are also more likely than men to develop symptoms.”

Israeli study finds 94% drop in symptomatic COVID-19 cases with Pfizer vaccine: “Israel's Clalit health maintenance organization says it has seen a 94% decrease in symptomatic COVID-19 infections among 600,000 people who received two doses of Pfizer's vaccine, as reported in the Financial Post…
The Clalit healthcare provider, which covers more than half of all Israelis, also said the same group was also 92% less likely to develop severe COVID-19.”

Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: They don’t work.

Hospitals face severe shortages as pandemic grinds forward: “Hospitals around the country say their supplies of crucial medical supplies including personal protective equipment (PPE) are lower than ever as demand for different items has soared to an all-time high.
Data detailing usage rates of PPE and other supplies analyzed by Premier, a company that consults for health care systems, revealed that usage of supplies for COVID-19 testing and treatment has reached the highest rate seen since the pandemic began last year."

Novavax to complete US vaccine trial enrolment in record time:”Novavax, one of the unexpected success stories of the Covid-19 vaccine race, is about to finish enrolling its US trial in record time, bringing it another step closer to fulfilling orders to inoculate 50m Americans.
The 30-year-old biotech — which has never before successfully brought a drug to market — has almost enrolled the 30,000 participants in its US trial, which began in late December, according to its chief executive, Stanley Erck.”

U.S. Enrolls in WHO’s ACT Accelerator Program for Pandemic Relief: “The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and tests, and to help lower-income nations obtain them.
The WHO claims that the program is still in need of at least $26 billion to achieve its goals of delivering COVID-19 drugs and diagnostics to low- and middle-income countries.”

Covid-Linked Syndrome in Children Is Growing and Cases Are More Severe: “Doctors across the country have been seeing a striking increase in the number of young people with the condition Braden had, which is called Multisystem Inflammatory Syndrome in Children or MIS-C. Even more worrisome, they say, is that more patients are now very sick than during the first wave of cases, which alarmed doctors and parents around the world last spring…
The reasons are unclear. The surge follows the overall spike of Covid cases in the United States after the winter holiday season, and more cases may simply increase chances for severe disease to emerge. So far, there’s no evidence that recent coronavirus variants are responsible, and experts say it is too early to speculate about any impact of variants on the syndrome.”

Keeping schools open without masks or quarantines doubled Swedish teachers’ COVID-19 risk: “A careful analysis of health data from Sweden suggests keeping schools open with only minimal precautions in the spring roughly doubled teachers’ risk of being diagnosed with the pandemic coronavirus. Their partners faced a 29% higher risk of becoming infected than partners of teachers who shifted to teaching online. Parents of children in school were 17% more likely to be diagnosed with COVID-19 than those whose children were in remote learning.”

WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out: “WHO listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.”

Seven coronavirus variants potentially similar to UK type have been detected in US: study: “Seven variants of the COVID-19 virus have been detected in the U.S., and all or some of them may contain mutations similar to the qualities exhibited by a strain of extra-contagious COVID-19 spreading in the United Kingdom, a new study found.
The study, published Sunday on MedRxiv.org, found seven previously undiscovered variants of COVID-19 in U.S. patients, all of which are thought to have originated domestically…”

About pharma

2021 Medication Access Report: “CoverMyMeds conducted surveys of patients, providers and pharmacists over a two-month period during September and October 2020. We surveyed 1,000 patients, 400 providers and 328 pharmacists to achieve a 95 percent confidence interval and achieved a ±5 percent margin of error…
Over 40 percent of all patients said to stretch out their prescription, they skipped or reduced doses, potentially putting their health and adherence at risk.8 The proportion was even higher for uninsured patients, at 58 percent, and those on Affordable Care Act (ACA) plans, at 60 percent.”
Forty-three percent of patients said they checked a pharmacy comparison app to find cheaper medications prices, up from 28 percent the previous year.
Read the study for more details.

The top 10 biotech IPOs of 2020: FYI, with details on each.

Plavix partners Sanofi, Bristol Myers vow to appeal Hawaii's $834M marketing verdict: “Sanofi and Bristol Myers Squibb have spent years battling Plavix litigation—including state-level claims that the drugmakers didn’t adequately warn about the blood thinner's risks to certain patients.
Now, a judge in Hawaii has ordered each company to pay the state $417 million for failing to fully disclose its risks in non-white patients.”

Gilead lets local HIV community groups take the lead with $3 million grant: Gilead “is pledging $3.2 million over two years to the Human Rights Campaign, the largest lesbian, gay, bisexual, transgender and queer (LGBTQ+) civil rights organization in the U.S. The money will be distributed through the campaign's educational arm to support communities disproportionately affected by HIV, particularly communities of color.”

About healthcare IT

Mobile Health Apps Systematically Expose PII and PHI Through APIs, New Findings from Knight Ink and Approov Show: A recently released study showed that “fully 100 percent of the 30 popular mHealth apps analyzed by Alissa Knight, partner at Knight Ink, are vulnerable to API attacks that can allow unauthorized access to full patient records including protected health information (PHI) and personally identifiable information (PII).” usage of the APIs put at least 23 million people at risk.

Third party breach exposed data on 35-million, Florida insurer says: “Hackers attacked Florida Healthy Kids Corp.'s web hosting vendor and inappropriately accessed and tampered with the addresses of some of the 3.5 million people affected.”

About health insurance

New enrollment window opens for health insurance shoppers: “A sign-up window opened Monday for government insurance markets and runs through May 15 in most states. It’s available for people who don’t have coverage through work, and it is expected to make finding a plan less of a hassle for those who lost a job.”

CVS' Lynch: Aetna planning to re-enter ACA exchanges in 2022: The insurer had pulled out of such markets in 2018 after sustaining losses. These markets are more stable now and easier for plans to analyze.

About hospitals and health systems

Association of Medicaid Expansion With Quality in Safety-Net Hospitals: “This difference-in-differences cohort study found that despite reductions in uncompensated care and improvements in operating margins, there appears to be little evidence of quality improvement among SNHs in states that expanded Medicaid compared with those in states that did not.” The question of what they do need to improve results is not clear- is it more money, expertise, or a combination?

About the public’s health

Recommended Adult Immunization Schedule, United States, 2021: Click on the chart to enlarge it.

About diagnostics

Guardant Health launches surveillance blood test for detecting colorectal cancer recurrence: “Guardant Health has launched a simple blood test to monitor patients after undergoing surgery for colorectal cancer to spot any early signs that tumor cells remain or to catch the disease before it returns.
The Guardant Reveal test, expected to turn around results in one week, is the company’s first liquid biopsy to help manage the treatment of early-stage cancer, and the company plans to make it available for other cancer types in the future.”

Today's News and Commentary

About COVID-19

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platform trial (Preprint, not yet peer reviewed): “Patients allocated to tocilizumab were more likely to be discharged from hospital alive within 28 days (54% vs. 47%; rate ratio 1.23; 95% CI 1.12-1.34; p<0.0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (33% vs. 38%; risk ratio 0.85; 95% CI 0.78-0.93; p=0.0005). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes regardless of the level of respiratory support received and in addition to the use of systemic corticosteroids.”

Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study: “Early initiation of prophylactic anticoagulation compared with no anticoagulation among patients admitted to hospital with covid-19 was associated with a decreased risk of 30 day mortality and no increased risk of serious bleeding events. These findings provide strong real world evidence to support guidelines recommending the use of prophylactic anticoagulation as initial treatment for patients with covid-19 on hospital admission.”

Next coronavirus vaccines may be sprays, pills or printed on demand: The headline speaks for itself.

As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running: ”More than 34 million Americans have received Covid vaccines, but the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.
For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems.”

CDC gives road map for safely reopening schools: Masking and hand washing are musts.
”When infection rates in the community are higher, the agency recommends shifting to a combination of in-person and remote learning to minimize the number of people in school buildings at any given time. Fully remote learning is recommended only in certain cases when virus rates are very high.
And while the CDC reiterated that states should prioritize teachers for vaccination, the agency said it is not a prerequisite for reopening.”

About health insurance

Voya finds employees still don’t understand their benefits: “35% of employed individuals do not fully understand any of the employee benefits they’ve selected, according to a new survey by Voya Financial. Millennials in particular have a hard time navigating their benefits, with 54% saying they don't understand their offerings.” 66% say they want employers to help them understand the benefits.

How Much Does a C-Section Cost? At One Hospital, Anywhere From $6,241 to $60,584: The availability of hospital charge data has given the media the opportunity to get “actual” numbers on the spread of these figures. In a related article: How Hospitals Are Faring in Meeting Price Transparency Requirements: The hospitals charge data must be in both consumer-friendly and machine-readable formats. 40% of hospitals are not compliant with the former and 52% are not compliant with the latter. “Overall, most providers were compliant with at least one of the file types, though approximately 30% of providers were not compliant for either. Hospitals that are not compliant have expressed they either have significant resource constraints (COVID-19 or otherwise), a lack of understanding of the ruling, and/or are waiting to see what their competitors are doing.”

The Health Cost of Cost Sharing: The cost-quality tradeoff due to cost sharing has been debated for decades. Cost sharing reduces utilization; but it can cause reductions in necessary as well as unnecessary care. The research from the NBER sheds more light on this issue. You should read the entire abstract below:
”We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in coinsurance, or $10.40 per drug) causes a 22.6% drop in total drug consumption ($61.20), and a 32.7% increase in monthly mortality (0.048 p.p.). Second, we trace this mortality effect to cutbacks in life-saving medicines like statins and antihypertensives, for which clinical trials show large mortality benefits. We find no indication that these reductions in demand affect only ‘low-value’ drugs; on the contrary, those at the highest risk of heart attack and stroke, who would benefit the most from statins and antihypertensives, cut back more on these drugs than lower risk patients. Similar patterns exist for other drug–disease pairs, and irrespective of socioeconomic circumstance. Finally, we document that when faced with complex, high-dimensional choice problems, patients respond in simple, perverse ways. Specifically, price increases cause 18.0% more patients (2.8 p.p.) to fill no drugs, regardless of how many drugs they had been on previously, or their health risks. This decision mechanically results in larger absolute reductions in utilization for those on many drugs. We conclude that cost-sharing schemes should be evaluated based on their overall impact on welfare, which can be very different from the price elasticity of demand.”

Edited Transcript of MOH.N [Molina Health] earnings conference call or presentation 11-Feb-21: Despite increased revenue and membership growth, such factors as COVID-19 and acquisition expenses led to a $100M dip in year over year profits.

Biden moving to withdraw Trump-approved Medicaid work rules: “The Biden administration on Friday will notify states it plans to revoke Medicaid work requirements, starting the process of dismantling one of the Trump administration's signature health policies.” However, a related article, HHS Faces Hurdles Revising Medicare Interpretive Rules, points out that some of Biden’s changes require a 90 day comment period before they can take effect.

About pharma

Bristol Myers Squibb pens $1.3B biobucks pact with Molecular Templates, axes Celgene CAR-T asset: ”Bristol Myers Squibb is putting down up to $1.3 billion on a next-gen engineered toxin body (ETB) cancer platform from Molecular Templates as it cuts an unwanted cell therapy from its Celgene buyout.”
The deal is “worth just $70 million upfront with the rest in milestones…
ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms of action, including the ability to force receptor internalization, deliver therapeutic payloads and directly kill targeted cells through the enzymatic inactivation of ribosomes.”

Gilead's $5B Galapagos black hole widens as pair tosses out phase 3 asset after flop: “Gilead has sunk billions into Galapagos over the past few years, but this is quickly turning into one of the most disastrous biotech deals in recent history [as]… an independent body checked out its phase 3 data for the experimental autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).
The outcome was not good. Following a regular review of unblinded data, an independent monitoring board “concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies.”

Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod: “After regulatory delays and manufacturing issues caused Bristol Myers Squibb investors to miss out on Celgene contingent value rights, the closely watched CAR-T drug liso-cel has scored an FDA nod. 
Friday, the agency endorsed the drug, to be called Breyanzi, to treat patients with certain types of large B-cell lymphoma who haven’t responded to two other systemic treatments or who have relapsed after receiving those treatments.”

US Pays Pfizer, Moderna $3.7B For 200M More Vaccine Doses: “The Biden administration on Thursday ordered a total of 200 million additional doses of the COVID-19 vaccines from Pfizer Inc. and Moderna Inc., purchases that mean all Americans could be vaccinated by the end of the summer, according to President Joe Biden.
The federal government shelled out about $2 billion to Pfizer and its German partner BioNTech, and $1.65 billion to Moderna for the additional doses, according to a joint statement from the U.S. Department of Health and Human Services and the U.S. Department of Defense.”

Regeneron's Evkeeza, carrying big price tag, wins FDA approval in ultra-rare cholesterol disease: “Regeneron has been battling against rival Amgen with their mass-market PCSK9 cholesterol drugs, and now the company is underway with a new launch to match its rival in the ultra-rare disease homozygous familial hypercholesterolemia (HoFH).
Regeneron’s Evkeeza scored approval on Thursday as an add-on to other lipid-lowering therapies in patients 12 and older with HoFH, which affects approximately 1,300 patients in the U.S. The company has a "dedicated and experienced team in place" to support the rollout, a spokesman said. The drug is given once per month through an intravenous infusion…
The new drug is dosed by weight and will carry a list price of about $450,000 per year on average, Regeneron said.”
Hospitals Ask Supreme Court to Take Up 340B, Site-Neutral Payments: “The American Hospital Association (AHA), joined by member hospitals and other national organizations, have filed petitions asking the Supreme Court to reverse two appeals court decisions impacting hospital payments.
The first case involves a lawsuit brought on by the AHA and other organizations challenging the nearly 30 percent cut to Medicare outpatient prospective payment system drug payments for hospitals participating in the federal 340B Drug Pricing Program.
A district court had sided with the hospital groups, ruling that the payment reduction was unlawful. However, an appeals court overturned the decision in July 2020, finding HHS to be within its statutory boundaries with the rate reductions.
The second case hospitals are asking the Supreme Court to consider again involves reductions to Medicare outpatient prospective system payments. This time, AHA and others are challenging a 2019 site-neutral payment policy that reduced rates for clinic visits delivered at off-campus provider-based departments.”

About healthcare IT

Signify Health raises $564M in its IPO driven by investor interest in home care, value-based models: Signify Health launched in December 2017 as the result of a merger between CenseoHealth and Advance Health. The company provides a value-based care platform that uses advanced analytics and other technology to shift health services toward the home.”

This startup is using telehealth to provide eating disorder therapy, and it just got backing from Optum: “A startup providing online eating disorder therapy has raised $13 million as investors ramp up funding for virtual care providers that target specific behavioral health conditions. 
San Diego-based Equip virtually delivers evidence-based eating disorder treatment to families at home and has raised $17 million to date. The series A round was led by Optum Ventures with participation from new investor .406 Ventures and existing investor F-Prime Capital, which led the company’s prior seed round.”

Today's News and Commentary

About COVID-19

Single dose of Pfizer vaccine shows signs of success in UK: “Public Health England found that a single dose reduced symptomatic infection by 65 per cent in younger adults and 64 per cent in the over-80s, while two jabs conferred 79 and 84 per cent protection respectively.”

WHO recommends use of Oxford/AstraZeneca vaccine for all adults: “The WHO’s Strategic Advisory Group of Experts on Immunization (Sage) said the vaccine could be used by all people over the age of 18 in all countries, including places such as South Africa where the circulation of new variants had raised some concerns over its efficacy.”

Infographic: COVID-19 patients with high-risk conditions 3x more likely to need the ICU: This Blue Cross Blue Shield Association analysis of 90,900 COVID-19 cases across 4.5 million Americans found the average cost per admission for high-risk COVID-19 patients (26%) was 30 percent higher than for patients without underlying chronic conditions (74%). Of the 95% of the total who did not require hospitalization, the average cost of treatment was between $500 and $1,000. But for the 5% who were hospitalized treatment costs were 45 times higher than in an outpatient setting.

Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States: This updated CDC guidance includes the following change:
”…vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:

  • Are fully vaccinated (i.e., ≥2 weeks following receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine)

  • Are within 3 months following receipt of the last dose in the series

  • Have remained asymptomatic since the current COVID-19 exposure

Persons who do not meet all 3 of the above criteria should continue to follow current quarantine guidance after exposure to someone with suspected or confirmed COVID-19.”

Biden to announce his administration has secured 200 million additional vaccine doses promised last month: “President Biden is expected to announce Thursday afternoon that his administration has secured deals for another 200 million doses of coronavirus vaccine as promised last month, according to three people familiar with the matter who were not authorized to discuss it.” 100M each from Pfizer and Moderna.

FDA Says COVID-19 Treatment Remdesivir Shouldn’t Be Compounded: “Gilead Sciences’ FDA-approved antiviral treatment for COVID-19, Veklury (remdesivir), should not be compounded, the FDA has warned.
The agency said it has recently learned that ‘various entities’ are offering to sell the active pharmaceutical ingredient in remdesivir to compounders and that the products could be ‘substandard or counterfeit.’”

Can’t Find an N95 Mask? This Company Has 30 Million That It Can’t Sell.: “A year into the pandemic, the disposable, virus-filtering N95 mask remains a coveted piece of protective gear. Continuing shortages have forced doctors and nurses to reuse their N95s, and ordinary Americans have scoured the internet — mostly in vain — to get them.
But Luis Arguello Jr. has plenty of N95s for sale — 30 million of them, in fact, which his family-run business, DemeTech, manufactured in its factories in Miami. He simply can’t find buyers…
In one of the more confounding disconnects between the laws of supply and demand, many of the nearly two dozen small American companies that recently jumped into the business of making N95s are facing the abyss — unable to crack the market, despite vows from both former President Donald Trump and President Biden to ‘Buy American’ and buoy domestic production of essential medical gear.”

About healthcare IT

Cerner's net earnings up $250M in 2020: 4 things to know: “Cerner reported $780.1 million in net earnings in 2020, a 47 percent increase from $529.5 million in 2019…
For the full year, Cerner posted $5.5 billion in revenue, down 3 percent from $5.6 billion in 2019.”

20 medical apps most downloaded by iPhone users: FYI

14 health systems team up on 'ethical innovation' with launch of provider-led data platform:
“Fourteen health systems, including Trinity Health, Northwell Health and Tenet Health, are partnering to create a comprehensive, de-identified data platform that will glean more robust insights on medical conditions such as rare diseases and COVID-19.
The new platform, dubbed Truveta, will serve as a universal database of patient population information pooled from the participating health systems, according to a Feb. 11 announcement.
The de-identified clinical data will span across all diagnoses, geographies and demographics to provide physicians and researchers with stronger analyses of medical conditions, treatment therapies and prognoses.”

About pharma

AstraZeneca drops breast, prostate cancer programs in Q4 pipeline cull: “AstraZeneca has dropped two oncology programs from its clinical-phase pipeline. The Big Pharma has stopped work on AZD9496 in breast cancer and imaradenant in prostate cancer on safety or efficacy grounds.”

About health insurance

Humana Begins Coverage of Hospice Services as Part of Medicare Demonstration: “As part of a four-year demonstration created by the U.S. Centers for Medicare & Medicaid Services (CMS), Humana’s program is intended to help the company and CMS learn whether hospice services provided within the Part A benefits package of Medicare results in additional innovation, enables a more seamless care continuum and improves quality and timely access to palliative and hospice care. Humana started offering the new benefit on select plans on January 1, 2021, in order to ease care transitions and ensure hospice-eligible patients who need it can receive the full benefits of hospice care.”
Hospice has been a stand-alone program, so this initiative’s innovation is integrating hospice into Medicare A and Medicare Advantage plans.

Medicare FFS Utilization Decreased During the COVID-19 Pandemic: “Avalere found healthcare utilization decreased in the first 3 months of the pandemic (March, April, and May of 2020) compared to these same months in 2019. This decrease was largest in April when there was a 51% reduction in outpatient claims and a 42% reduction in professional claims in 2020 compared to 2019. valere also examined healthcare utilization changes between the first half of 2019 and 2020 by race and found that utilization among the White Medicare population decreased more than among the Black or Hispanic populations. However, the largest utilization decreases were observed among the Asian beneficiaries, who account for 2% of the overall Medicare FFS population (White Medicare beneficiaries constitute 81%; Black Medicare beneficiaries, 9%; and Hispanic Medicare beneficiaries, 2%…).”

About hospitals and health systems

Crises Collide:The COVID-19 Pandemic and the Stability of the Rural Health Safety Net: The Chartis Center for Rural Health found that: “Today the stability of the rural health safety net is even more tenuous. Rural hospital closures now stand at 135,1 and our research indicates that another 453 are vulnerable…
For the average rural hospital, 77 percent of total revenue is associated with outpatient services. As the pandemic has progressed, many rural providers have suspended or limited outpatient procedures, further compounding financial instability. In addition, our analysis has shown that the average rural hospital has 33 days cash on hand.to closure.”

Today's News and Commentary

About COVID-19

Seasonal human coronavirus antibodies are boosted upon SARS-CoV-2 infection but not associated with protection: “Our studies indicate that most individuals possessed hCoV [human coronavirus]-reactive antibodies before the COVID-19 pandemic. We determined that ∼20% of these individuals possessed non-neutralizing antibodies that cross-reacted with SARS-CoV-2 spike and nucleocapsid proteins. These antibodies were not associated with protection against SARS-CoV-2 infections or hospitalizations, but they were boosted upon SARS-CoV-2 infection.”

U.S. to start sending COVID-19 vaccines directly to community health centers: “The government will send doses to 250 centers nationwide selected based on their proximity to vulnerable groups, such as homeless people and those with limited proficiency in English, they said. Typically, vaccine doses would go to state governments for distribution to health centers.
Eventually the effort will expand to more than 1,300 community health centers.”

Verily links with Janssen for at-home COVID-19 immune system study: “Verily is teaming up with Johnson & Johnson’s Janssen division to observe the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their own homes. 
The study will be launched through Verily’s Project Baseline testing program and aims to collect biological information and real-world data in the weeks immediately after a person tests positive for COVID-19.”
Verily is “Google’s life-science-focused sibling company…”

About hospitals and health systems

Tenet Healthcare posts $414M profit in 4th quarter: “Tenet Healthcare beat Wall Street expectations Tuesday as it posted a profit of $414 million, or $3.86 per share, in the final quarter of a year of historic challenges.
The fourth-quarter earnings are a jump from a loss of $3 million, or three cents per share, in the same quarter of 2019. The Dallas-based health system reported revenue was up 2.2% at $4.9 billion for the quarter from fourth-quarter revenue in 2019.”

Kaiser Permanente income narrowed to $2.2B last year amid COVID-19 squeeze: “Kaiser Permanente generated $2.2 billion in operating income last year as the hospital system weathered financial challenges from the pandemic.
Kaiser announced late Friday that it generated $88.7 billion in total operating revenue in 2020, up about 5% compared with $84.5 billion the year before. The system’s operating income dropped to $2.2 billion, down about 19% from the income of $2.7 billion generated in 2019.
The system touted membership gains in its health plan and its ‘integrated model’ in handling the financial fallout from COVID-19 that forced patient volumes to plummet.”
An example of payer-provider integration that shields such a system from losses when “volumes plummet.”

Negligent Credentialing Suit in Iowa Could Affect Hospitals Everywhere: This case is perhaps the most-talked-about action in healthcare because of far-reaching implications. “Should the Iowa Supreme Court recognize that there is a tort claim for negligent credentialing, it could spell increased accountability and liability for hospitals.” Read the article for more details.

Hospitals’ Covid-19 heroics have them poised for power in the new Washington: “The hospital business is booming on Capitol Hill like never before. Lawmakers showered the industry with more than $275 billion last year, and handed hospitals wins even on seemingly unrelated issues. And Democrats’ agenda will almost certainly be better for their bottom lines.
The Covid-19 pandemic has transformed the industry’s image in Washington, where large health care systems have long been vilified as corporate profit mongers instead of community caregivers. Now, more than two dozen lobbyists and consultants told STAT that they are keenly aware of just how much power the industry has accrued — and are prepared to seize the moment.”

7 hospital construction projects costing $500M or more: FYI

About healthcare IT

50-State Survey of Telehealth Commercial Insurance Laws: A really good summary as of January, 2021 by law firm Foley & Lardner.

Nuance Announces Acquisition of Saykara: “ Nuance Communications, Inc…. announced the acquisition of Saykara, Inc., a like-minded startup focused on developing a mobile AI assistant to automate clinical documentation for physicians. The acquisition underscores Nuance's ongoing expansion of market and technical leadership in conversational artificial intelligence (AI) and ambient clinical intelligence (ACI) solutions that reduce clinician burnout, enhance patient experiences, and improve overall health system financial integrity.”

Stolen Chatham county data posted online after cyber incident, includes personnel files, other sensitive documents: Cyber criminals are serious about the consequences of not cooperating with them. “Sensitive data files stolen following Chatham County’s Oct. 28 governmental 'cyber incident’ have been posted online by the criminal enterprise responsible, the News + Record has learned.
The files include such things as personnel records of some county employees, medical evaluations of children who are the subjects of neglect cases, eviction notices and documents related to ongoing investigations within the Chatham County Sheriff’s office.”

Physiological Data from a Wearable Device Identifies SARS-CoV-2 Infection and Symptoms and Predicts COVID-19 Diagnosis: Observational Study: “Longitudinally collected HRV [heart rate variability] metrics from a commonly worn commercial wearable device (Apple Watch) can identify the diagnosis of COVID-19 and COVID-19 related symptoms. Prior to the diagnosis of COVID-19 by nasal PCR, significant changes in HRV were observed demonstrating its predictive ability to identify COVID-19 infection.”

Deep-learning-assisted analysis of echocardiographic videos improves predictions of all-cause mortality: Published research from Geisinger Clinic: “Here we show that a convolutional neural network trained on raw pixel data in 812,278 echocardiographic videos from 34,362 individuals provides superior predictions of one-year all-cause mortality. The model’s predictions outperformed the widely used pooled cohort equations, the Seattle Heart Failure score (measured in an independent dataset of 2,404 patients with heart failure who underwent 3,384 echocardiograms), and a machine learning model involving 58 human-derived variables from echocardiograms and 100 clinical variables derived from electronic health records. We also show that cardiologists assisted by the model substantially improved the sensitivity of their predictions of one-year all-cause mortality by 13% while maintaining prediction specificity. Large unstructured datasets may enable deep learning to improve a wide range of clinical prediction models.”

About pharma

Fresenius To Pay $50M For Impeding FDA Investigation: “Indian drug manufacturer Fresenius Kabi Oncology Ltd. will plead guilty and pay $50 million to end claims that it destroyed and hid records related to the production of cancer drugs before a 2013 investigation by the U. S. Food and Drug Administration, the U. S. Department of Justice announced Tuesday. The DOJ charged FKOL in Nevada federal court with violating the Federal Food, Drug and Cosmetic Act for failing to turn over certain documents requested by the FDA, prosecutors said in a release.”

PacBio nets $900M from SoftBank to support its long-read sequencing goals: “Just over a year after Illumina’s $1.2 billion bid for its fellow sequencer manufacturer fell apart under federal scrutiny, Pacific Biosciences has secured a new benefactor with a $900 million commitment from SoftBank.
The Japanese conglomerate has signed up to purchase convertible senior notes due in 2028 at $43.50 apiece, or a 30% premium above PacBio’s 30-day closing average, through its SB Management subsidiary.”

About healthcare professionals

Apollo To Make An Up To $470M Investment In Health Care Biz: “Apollo Global Management said Tuesday it will make an up to $470 million investment in emergency medicine and hospitalist services business US Acute Care Solutions as the physician-owned group buys out the minority stake of a separate private equity firm. Apollo's preferred equity stake in the Canton, Ohio-based business facilitates a full recapitalization of the company, as well as an exit of Welsh Carson Anderson & Stowe, the asset manager said. As a result of the deal, USACS will be 90% owned by its physicians and continue to be controlled by its doctors..”

About health insurance

Biden Administration Backs ACA at Top Court, Flipping Trump’s Stance: “President Joe Biden’s administration told the U.S. Supreme Court the Affordable Care Act is constitutional, filing an unusual letter that flips the government’s position three months after the justices heard arguments on the law.
The Trump administration had argued against the health-care law, also known as Obamacare, when the justices heard the case Nov. 10.
Opponents are trying to invalidate the entire law by pointing to a Republican-backed 2017 tax change that eliminated a penalty for not having insurance. The penalty was central to the 2012 Supreme Court decision that upheld the so-called individual mandate to have insurance as a legitimate use of Congress’ constitutional taxing power.”


Amid Pandemic, 53% of California Employers Prefer Health Plans with High-quality Providers Over Low-cost Plans; 86% Will Pay More for Top-quality Networks: “When researchers asked California health benefit managers to rank priorities, the study found that:

·       Fifty-three percent (53%) of businesses preferred offering health plans that featured high-quality care providers

·       Less than half of employers (42%) prioritized low-cost plans with smaller provider networks

·       Eighty-six percent (86%) of employers would pay more for plans with the best-rated health care providers

The survey’s results reflect other impacts of the pandemic, as well. For example:

·       Seventy-one percent (71%) of health benefit decision-makers surveyed reported their employees having to switch doctors because of the pandemic; of this group, 93% said they expect employees to pick health plans with in-network doctors close to them.

·       Forty-two percent (42%) of employers preferred health plans with telehealth and virtual-care options; these allow employees to engage providers and use resources while practicing social distancing.”

 

Today's News and Commentary

About the public’s health

As alcohol abuse rises amid pandemic, hospitals see a wave of deadly liver disease: “Although national figures are not available, admissions for alcoholic liver disease at Keck Hospital of USC were up 30% in 2020 compared with 2019, said Dr. Brian Lee, a transplant hepatologist who treats the condition in alcoholics. 
Specialists at hospitals affiliated with the University of Michigan, Northwestern University, Harvard University and Mount Sinai Health System in New York City said rates of admissions for alcoholic liver disease have leapt by up to 50% since March.”

Anthropogenic climate change is worsening North American pollen seasons: ”Our results indicate that human-caused climate change has already worsened North American pollen seasons, and climate-driven pollen trends are likely to further exacerbate respiratory health impacts in coming decades.”

Incorporating Baseline Breast Density When Screening Women at Average Risk for Breast Cancer: “Baseline screening at age 40 years followed by annual screening at age 40 to 75 years for women with dense breasts and biennial screening at age 50 to 75 years for women without dense breasts was effective and cost-effective, yielding an incremental cost-effectiveness ratio of $36 200 per QALY versus the biennial strategy at age 50 to 75 years.”
An accompanying editorial provides an important critique. Among the comments:

“Several aspects of Shih and colleagues' results are surprising and inconsistent with prior studies… Generally, annual screening results in a higher ratio of harms to benefits because few added deaths are averted—compared with biennial screening—whereas the added cost of annual screening is large. The screening strategy proposed by Shih and colleagues would do annual screening on 60% of women, which raises questions about how it could be cost-effective.
Breast density is an important risk factor to include in risk-based screening strategies because it is both a strong and prevalent risk factor accounting for a large proportion of breast cancers. However, we argue that breast density should be combined with age and other risk factors when developing risk-based screening strategies that optimize benefits and minimize harms. We believe that until a more robust risk-based strategy is identified, the frontier curves presented in Shih and colleagues' analyses support screening biennially from ages 50 to 74 years.”

Segregation, Poverty Tied to Worse Outcomes for Black Lung Cancer Patients: “For years, U.S. studies have documented racial disparities in lung cancer. Black Americans are less likely to receive surgery for early-stage lung cancer -- the standard of care -- and they typically die sooner.
The reasons, however, are not fully clear.
Researchers said the new study implicates residential segregation -- a manifestation of structural racism -- in the disparities.
It found that Black lung cancer patients living in the most segregated U.S. counties were 49% more likely to be diagnosed at an advanced stage, compared to those living in the least segregated counties.
And among those with early-stage lung cancer, Black patients in highly segregated areas were 47% less likely to receive surgery.”

About COVID-19

WHO team: Coronavirus unlikely to have leaked from China lab: “The coronavirus most likely first appeared in humans after jumping from an animal, a team of international and Chinese scientists looking for the origins of COVID-19 said Tuesday, saying an alternate theory that the virus leaked from a Chinese lab was unlikely. 
A closely watched visit by World Health Organization experts to Wuhan — the Chinese city where the first coronavirus cases were discovered — did not dramatically change the current understanding of the early days of the pandemic, said Peter Ben Embarek, the leader of the WHO mission.”

U.S. COVID-19 cases and hospitalizations log biggest weekly drops since pandemic started: “The United States reported a 25% drop in new cases of COVID-19 to about 825,000 last week, the biggest fall since the pandemic started, although health officials said they were worried new variants of the virus could slow or reverse this progress.
New cases of the virus have now fallen for four weeks in a row to the lowest level since early November, according to a Reuters analysis of state and county reports. The steepest drop was in California, where cases in the week ended Feb. 7 fell 48%. Only Oregon, Puerto Rico, Arkansas and Vermont saw cases rise.“

Most Americans say they will continue preventive measures after COVID-19 pandemic ends: “[Iahn Gonsenhauser, MD, chief quality and patient safety officer at The Ohio State University Wexner Medical Center] and colleagues surveyed more than 2,000 adults. Results showed that after the pandemic ends:

  • 72% plan to continue to wear masks in public;

  • 80% intend to still avoid crowds; and

  • 90% plan to frequently wash their hands and use sanitizer.”

The Big Number: During pandemic, heart surgeries plummeted by 53 percent: “The number comes from an analysis of national data through the end of 2020 and included information on 717,103 heart surgery patients and more than 20 million covid-19 patients. The finding was presented at a January meeting of the Society of Thoracic Surgeons.
The analysis found that adult cardiac surgery volume fell by more than half nationwide, to roughly 12,000 surgeries a month on average. The decline included 65 percent fewer elective surgeries and 40 percent fewer nonelective surgeries, with all types of heart operations experiencing a decline, including coronary artery bypass grafting, aortic or mitral valve replacement, a combination or something else.”
Understandable why elective surgeries were postponed, but a drop of 40% for non-elective procedures?

NHS Covid app prevented 600,000 infections, claim researchers: “The NHS contact-tracing app has prevented the transmission of hundreds of thousands of Covid-19 cases in England and Wales, researchers have estimated, in one of the world’s first studies of efficacy of the smartphone-based system developed in conjunction with Apple and Google. Researchers at the Alan Turing Institute and Oxford university have estimated that every 1 per cent increase in app users can reduce coronavirus cases by as much as 2.3 per cent. The app has sent 1.7m notifications to its more than 21m users telling people to isolate so far. Of those, the Turing/Oxford researchers estimate that about 600,000 cases were averted by the end of December.”

Pfizer Withdraws Emergency Use Application of COVID-19 Vaccine in India: “Pfizer has withdrawn its application for emergency use approval of its COVID-19 vaccine in India after the country’s drug regulator requested a domestic trial.
India’s vaccine regulatory authority called for a study on safety and immune responses in its population, while Pfizer sought to have the trial requirements waived based on its currently available global phase 3 data.”
This story is a small item but raises large questions. Usually it is the US that requires domestic studies when a drug or device is approved elsewhere in the world. I suspect this turnabout has more to do with India protecting its domestic vaccine industry (the world largest) than the quality of the Pfizer vaccine.

Coronavirus Vaccine Tracker: Excellent update on the history and status of coronovirus vaccines, as well as how they work. In The New York Times, but appears to have open access. See, also: Coronavirus Variants and Mutations.

About hospitals and health systems

7 hospitals buying land for expansions: Many hospitals went ahead with scheduled building plans this past year, but buying land now for expansion is a real committment.

Rochester's Destination Medical Center forges ahead, despite COVID-19: “Steps away from the Mayo Clinic in Rochester, the steel framework of a new $45 million structure bearing big ambitions has taken shape in recent months — rising in determined fashion despite the spread of the deadly COVID-19 virus.
Once completed, Discovery Square 2 is expected to welcome innovative health care firms just like its glassy sister structure known as One Discovery Square, the cornerstone of the $5.6 billion Destination Medical Center (DMC) project.
Now in its sixth year, DMC is a public-private economic development effort unlike any other in Minnesota history. With the world-renowned Mayo Clinic leading the charge — along with the city, Olmsted County and the state — the ambitious project is intent on dramatically retooling Minnesota's third-largest city into a ‘premier destination for health and wellness.’”

About health insurance

Centene Corporation Reports 2020 Results:

“Total revenues of $28.3 billion for the fourth quarter of 2020, representing 50% growth compared to the fourth quarter of 2019, and $111.1 billion for the full year 2020, representing 49% growth year-over-year…
—Diluted loss per share for the fourth quarter of 2020 of $(0.02), compared to diluted EPS of $0.49 for the fourth quarter of 2019. Diluted EPS for the full year 2020 of $3.12, compared to $3.14 for the full year 2019.
—Adjusted diluted EPS for the fourth quarter of 2020 of $0.46, compared to $0.73 for the fourth quarter of 2019. Adjusted diluted EPS for the full year 2020 of $5.00, compared to $4.42 for the full year 2019.”
In a related story: Centene launching organizational restructuring effort, will cull 3K employees, [and eliminate] 1.5K open jobs

Oscar Health, Inc. Announces Filing of Registration Statement for Proposed Initial Public Offering: “The number of shares of Class A common stock to be offered and the price range for the proposed offering have not yet been determined. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.”

About health IT

Effect of Wearing a Novel Electronic Wearable Device on Hand Hygiene[HH] Compliance Among Health Care Workers: “The use of this device did not change HH compliance, but increased the duration of hand rubbing and volume of ABHR [alcohol-based hand rubbing] used by HCWs [healthcare workers].”

About healthcare quality

America's Best Hospitals2021 America's 250 Best Hospitals: Healthgrade’s annual ratings. Note the conspicuous absence of academic medical centers in the top lists.

Who is Responsible for Discharge Education of Patients? A Multi-Institutional Survey of Internal Medicine Residents: “Of the 613 resident responses (63% response rate), 35% reported they were unsure which member of the multidisciplinary team is primarily responsible for discharge education. Residents who believed it was either the intern’s or the resident’s primary responsibility had 4.28 (95% CI, 2.51–7.30) and 3.01 (95% CI, 1.66–5.71) times the odds, respectively, of reporting doing discharge communication practices frequently compared to those who were not sure who was primarily responsible. To improve multidisciplinary discharge communication, residents called for the following among team members: (1) clarifying roles and responsibilities for communication with patients, (2) setting expectations for communication among multidisciplinary team members, and (3) redefining culture around discharges.”

2020 CAQH [Council for Affordable Quality Healthcare] INDEX®- Closing the Gap: The Industry Continues to Improve, But Opportunities for Automation Remain: “Data from the 2020 CAQH Index found that, of the $372 billion spent on administrative complexity in the United States healthcare system, $39 billion, or 10 percent, is spent conducting administrative transactions tracked by the CAQH Index . Of the $39 billion, the industry can save $16 .3 billion, or 42 percent of existing annual spend, by transitioning to fully electronic transactions . While the industry has already avoided $122 billion annually by automating administrative transactions, meaningful opportunities for additional savings remain for both the medical and dental industries.”

About healthcare spending

Breaking the cost curve—Deloitte predicts health spending as a percentage of GDP will decelerate over the next 20 years: Consultants at Deloitte think healthcare spending, as a percent of GDP, will slow over the next 20 years and cost less than current government projections. Reasons include “a well-being dividend—the return on investment for tools, systems, or protocols that help consumers to take an active role in their health and well-being…”
They also predict that: “three major changes will likely impact incumbent health care stakeholders, driving more revenue. These include:

  • The end of the general hospital as we know it

  • The slowdown of mass-produced biopharma

  • A seismic shift in the way health care is financed”

Today's News and Commentary

About COVID-19

Andy Slavitt wants to see most vaccines get administered within a week of shipping: An informative Washington Post interview about what we can expect in the near future from the Biden administration with respect to COVID-19.

Oxford/AstraZeneca jab fails to prevent mild and moderate Covid from S African strain, study shows: “In both the human trials and tests on the blood of those vaccinated, the jab showed significantly reduced efficacy against the 501Y.V2 viral variant, which is dominant in South Africa, according to the randomised, double-blind study seen by the Financial Times.
’A two-dose regimen of [the vaccine] did not show protection against mild-moderate Covid-19 due to [the South African variant]’, the study says, adding that efficacy against severe Covid-19, hospitalisations and deaths was not yet determined.”

New COVID-19 deaths in U.S. top 5,000 to set new single-day record: “According to the data, there were almost 5,100 coronavirus-related deaths on Thursday -- by far the most of any day since the pandemic began a year ago. The previous one-day record was about 4,500 deaths.”

Where Did Covid Come From? Investigator Foreshadows Fresh Clues: “Scientists probing the origins of the coronavirus are wrapping up a lengthy investigation in China and have found ‘important clues’ about a Wuhan seafood market’s role in the outbreak.
Peter Daszak, a New York-based zoologist assisting the World Health Organization-sponsored mission, said he anticipates the main findings will be released before his planned Feb. 10 departure. Speaking from the central city of Wuhan, where Covid-19 mushroomed in December 2019, Daszak said the 14-member group worked with experts in China and visited key hot spots and research centers to uncover ‘some real clues about what happened.’”

Biden health team hatches new vaccine strategy as variant threat builds: “The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks — all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots.
The agency confirmed Thursday that it plans to release draft guidance. It could come in two to three weeks, according to four people familiar with the discussion. In the meantime, federal and state officials are scrambling to track how widely the coronavirus variants first found in South Africa, Brazil and the United Kingdom are spreading in the United States.”

NHS plans for annual coronavirus vaccinations: “Nadhim Zahawi, the vaccines minister, told the BBC’s Andrew Marr Show that the government was expecting annual inoculations to take place every autumn in much the same way as flu prevention, adding: ‘Where you look at what variant of virus is spreading around the world, you rapidly produce a variant of vaccine, and then begin to vaccinate and protect the nation.’”

Biden to use Defense Production Act to increase supply of Covid-19 vaccines and tests: ”The Biden administration announced new initiatives Friday to speed up Covid-19 vaccinations and increase the availability of tests and protective gear — even as top health officials pleaded with Americans to double down on basic public health measures like wearing masks.
The White House will use the Defense Production Act to make at least 61 million at-home or point-of-care coronavirus tests available by summer. And the Defense Department will deploy more than 1,000 active military personnel to support state vaccination sites, beginning in California on Feb. 15.”

Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase: “Pfizer expects to nearly cut in half the amount of time it takes to produce a batch of COVID-19 vaccine from 110 days to an average of 60 as it makes the process more efficient and production is built out, the company told USA TODAY.”

Amazon Alexa can now tell you the nearest spot to get a Covid-19 test — here’s how to use it: “It works on phones and through the Amazon Echo smart speaker… it’s best on a phone or on an Echo with a screen since it shows you a list of the nearby locations and how far each place is. Here’s what you do.

  • Open the Alexa app on your phone.

  • Touch the “Tap to talk to Alexa” button at the top.

  • Say: “Where can I get tested for Covid-19?”

Alexa will return a list of nearby places using data pulled from GISCorps and other sources, such as Yelp…If you tap a location, you’ll see a phone number you can call to confirm that there are appointments available, if one is needed.”

About pharma

Drug used to treat arthritis may cause serious heart problems, cancer, FDA warns: “The FDA said Xeljanz, also known as tofacitinib, can increase a patient’s risk of developing serious heart-related problems and cancer, specifically in those being treated for rheumatoid arthritis.
The FDA said Thursday preliminary results from a safety clinical trial of Xeljanz, which compared it to a similar type of medication, revealed the potential risks.
The safety clinical trial was requested by the FDA, which also investigated other potential health risks including blood clots in the lungs and death, though the final results are not yet available.
In 2019, the FDA warned that interim trial results found there was an increased risk of blood clots and death in patients prescribed the higher 10 mg twice daily dosage.”

OIG: Part D opioid prescriptions dipped during onset of COVID-19 pandemic: “The report [from the Department of Health and Human Services’ Office of Inspector General (OIG)] looked at opioid prescriptions from January through August of 2020. It found that for most months, about 1.1 million Medicare Part D beneficiaries are getting a short-term opioid prescription, which is roughly the same rate as in 2019.
But there was a significant decline in the spring of 2020. In April, the number fell to 727,505 beneficiaries, a major one-third decline.”

Jazz Pharmaceuticals to Buy GW Pharmaceuticals for $7.2 Billion: “Jazz Pharmaceuticals is set to acquire GW Pharmaceuticals, a UK drugmaker known for its cannabidiol (CBD) products Epidiolex (cannabidiol) and Sativex (nabiximols), for a whopping $7.2 billion.
Sativex, a cannabis extract administered orally as a spray, received UK approval in 2010 for treatment of multiple sclerosis symptoms. The product is currently going through phase 3 trials to support FDA approval for treating spasticity associated with multiple sclerosis and spinal cord injury.”

COVAX Releases Distribution Plan for COVID-19 Vaccines: “The COVAX vaccine program aims to distribute almost 340 million vaccine doses during the first half of the year, according to its latest distribution plan.
COVAX — which is administered by GAVI, the Vaccine Alliance, with backing from the World Health Organization — aims to inoculate 3.3. percent of the populations of 145 participating nations during the first half of this year, including essential healthcare workers and groups deemed to be most vulnerable.”

20 most expensive prescription drugs in 2021: FYI

Novel immunotherapy approach to treat cat allergy: “Researchers from the Department of Infection and Immunity of the Luxembourg Institute of Health (LIH) brought forward the potential of high doses of a specific adjuvant molecule, namely CpG oligonucleotide, in successfully modulating the immune system's allergic response to the main cat allergen Fel d 1, thereby inducing a tolerance-promoting reaction and reverting the main hallmarks of cat allergy. The researchers analysed the molecular mechanisms underlying this tolerance and proposed a pre-clinical allergen-specific immunotherapy approach to improve the treatment and control of this common type of allergy. The full study results were published recently in the journal Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).”

About health insurance

MA Enrollment in Plans With Extra Benefits for Chronically Ill Tripled in 2021: “New analysis of 2021 benefits and enrollment from Avalere finds that 787 MA [Medicare Advantage] plans offered by 44 parent organizations are providing special supplemental benefits for the chronically ill (SSBCI) in 2021. Those plans represent 16% of all analyzed MA plans. A majority (86%) of the total Medicare beneficiary population live in counties where at least 1 MA plan that offers at least 1 type of SSBCI is available. Overall, in 2021, 15% of enrollees in non-employer MA plans are enrolled in plans offering SSBCI, as compared to 6% in 2020.”

Fla. Biz Owner Pleads Out Of $400M Health Fraud Case: “A Florida businesswoman settled out of criminal and civil charges stemming from what prosecutors say was a health care scheme involving the submission of $400 million worth of false medical equipment claims to Medicare and other federal health care programs, the U. S. Department of Justice said. Kelly Wolfe copped to conspiracy to commit health care fraud and filing a false tax return in 2017, charges that carry an up to 13-year prison sentence, in a plea deal…”

New UnitedHealthcare policies change coverage for lab tests, specialty drugs. Hospitals want CMS to review them: “The American Hospital Association urged CMS to review new policy changes from UnitedHealthcare for diagnostic and specialty pharmacy services that the insurer says are needed to lower medical costs.
In a Feb. 4 letter to acting CMS Administrator Elizabeth Richter, the AHA argued two new UnitedHealthcare policies ‘create significant barriers to access to necessary diagnostic and specialty pharmacy services for tens of millions of health plan enrollees.’
One policy is UnitedHealthcare's designated diagnostic provider program. Beginning July 1, diagnostic tests completed at a facility that isn't a "designated diagnostic provider" won't be covered for UnitedHealthcare's commercial health plan members. Labs that are designated diagnostic providers will be reimbursed at a fixed rate. 
Under the policy, coverage will be denied for patients who receive testing at a non-designated laboratory even if the provider is considered "in-network." UnitedHealthcare is providing members a one-time exemption if they use a non-designated lab, but otherwise, members will need to pay out of pocket for testing that is completed at a non-designated lab. The requirement doesn't include inpatient or emergency room tests.”

Today's News and Commentary

About COVID-19

Britain explores mixed COVID vaccine shots as variants threaten: “British researchers are to explore mixing doses of the Pfizer and AstraZeneca COVID-19 vaccines in a world first trial aimed at finding new ways to swiftly reduce coronavirus infections as new mutated variants emerge.”

U.S. FDA gearing up for rapid review of potential COVID-19 booster shots: “The U.S. Food and Drug Administration is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official said on Thursday.
Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval.”

About healthcare systems

Catholic health giants join 'equity pledge,' commit to fighting systemic racism: “Catholic health systems around the U.S.—including giants like CommonSpirit​​​​​​​ and Ascension—committed to address systemic racism by taking concrete steps to reduce health disparities, it was announced Thursday.
More than 20 health system members of the Catholic Health Association (CHA) joined the Confronting Racism by Achieving Health Equity commitment so far, officials said.”

About diagnostics

23andMe going public at $3.5B via merger with Branson's blank check company: “23andMe is merging with VG Acquisition Corp., a special purpose acquisition company founded by billionaire Richard Branson, to go public.
The deal values the consumer genetic testing company at $3.5 billion, including debt.
The deal is expected to close in the second calendar quarter of 2021.”

Roche's COVID-19 diagnostics boosted 2020 sales despite other testing losses: “Roche’s diagnostics division saw its sales grow 14% over the full year of 2020—totaling over 13.8 billion Swiss francs, or about $15.3 billion—with demand for COVID-19 testing more than outweighing its losses due to clinic lockdowns and deferred health screenings.
The company launched 15 different tests for COVID-19 over the past year, including both rapid, point-of-care solutions and high-throughput, centralized laboratory diagnostics across each type of test, including antigen-, antibody- and molecular-based methods. Other tests worked to gauge the potential severity of a person’s immune response to the virus.”

About healthcare IT

Letter to the Editor: New phones, old problem? Interference with cardiovascular implantable electronic devices by phones containing magnets: “In a patient with a Medtronic Inc. Cobalt Cardiac Resynchronisation Therapy-Defibrillator (CRT-D) device (Minneapolis, MN, USA), therapies were suspended when the iPhone 12 was brought within close proximity of the generator, which was a consistent observation throughout the testing procedure. These findings raise possible safety concerns around MagSafe technology and cardiovascular implantable electronic devices (CIED). It is unknown whether this interference is a consistent observation across device types and manufacturers of CIED, or whether this is unique to the iPhone 12.”
Watch for further media stories about this finding.

Google expands into health tracking using smartphone cameras to monitor heart, respiratory rates: “Google Health, the tech giant’s health and wellness division, has added new features to its Google Fit app that enables users to take their pulse just by using their smart phone's camera…
The new features will be available in the Google Fit app for Pixel phones in the next month, with plans to expand to more Android devices, the company said…”
Read the article to understand how the technology works.

About pharma

Pfizer, Johnson & Johnson balk at shareholders' push for COVID-19 vaccine pricing info: “Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission (SEC) to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines.
Several not-for-profit groups are pushing the two companies—along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three.”

Coronavirus latest: Gilead’s Covid drug [Remdesivir] delivers $2bn boost to quarterly revenue – as it happened: The headline speaks for itself.

BioNTech fund pays €600m dividend on back of vaccine success: “One of the early backers of Germany’s BioNTech will pay a dividend of €600m to its own investors after selling most of its stake in the developer of the Covid-19 vaccine for a 4,500 per cent net return. Munich-based venture capital fund MIG is making the payout after initially investing just over €13m in BioNTech, the start-up founded by Ugur Sahin and Ozlem Tureci in 2008.”

Bristol Myers Secures COVID-19 Antibody Through Rockefeller University Pact: “The antibody is a combination of two drugs that together block the SARS-CoV-2 spike protein to neutralize the virus, and preclinical data indicate it could be an effective treatment against the virus’ multiple variants…
Financial details of the agreement were not disclosed but Rockefeller will receive royalty payments on any future sales.”

Walmart Loses Bid To Short-Circuit Feds' Opioid Suit: “A Texas federal judge on Thursday axed Walmart Inc. 's lawsuit seeking a declaration that its prescription opioid sales are lawful, ruling that the retail giant hadn't identified a Justice Department action that has adversely affected it and therefore can't preemptively sue the government.”
Walmart’s move was to preempt federal lawsuits for its role in the opioid crisis.

About health insurance

Cigna execs say COVID-19 costs outstripped savings from lower utilization at end of 2020: “Chief Financial Officer Brian Evanko told investors on the company's earnings call Thursday that the ratio between COVID costs and decreases in care utilization evolved over the course of the year. In the second quarter, for instance, savings from care deferrals significantly offset costs related to the pandemic.
In Q3, by contrast, COVID costs were largely on par with savings related to lower utilization, Evanko said. By the end of the fourth quarter, however, costs related to COVID-19 were higher than money saved in care deferrals, he said.”

About the public’s health

Vaccines Saved 37 Million Lives, Mostly Children, Over Past Two Decades: “Vaccinations are also projected to prevent a total of 69 million deaths between 2000 and 2030, researchers say.
Their modeling study also shows that vaccination against the 10 diseases -- including measles, rotavirus, HPV and hepatitis B -- means that people born in 2019 will have a 72% lower risk of death from those diseases over their lifetime.”

High levels of toxic heavy metals found in some baby food: U.S. report: “The [House Oversight subcommittee] panel examined products made by Nurture Inc, Hain Celestial Group Inc, Beech-Nut Nutrition and Gerber, a unit of Nestle, it said, adding that it was ‘greatly concerned’ that Walmart Inc, Campbell Soup Co and Sprout Organic Foods refused to cooperate with the investigation. The U.S. baby food market was worth an estimated $8 billion in 2020, according to Euromonitor.
The report said internal company standards ‘permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.’
The report urged U.S. regulators to set maximum levels of toxic heavy metals permitted in baby foods and require manufacturers to test finished products for heavy metals, not just ingredients, while baby food companies said they were working to reducing levels of metals that occur naturally in food products.”

28 Black medical pioneers to know: In honor of Black History Month, this list is a great historical read, in addition to celebrating individual accomplishments.



Today's News and Commentary

Several articles of general interest by key thought leaders:

Addressing Consolidation in Health Care Markets

Vital Directions For Health And Health Care: Priorities For 2021

Health Costs And Financing: Challenges And Strategies For A New Administration: The article focuses on affordability, access and equity. Quality per se is not discussed, except a small section on value-based compensation.

About COVID-19

Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine: “Pharmaceutical giant Johnson & Johnson submitted its single-shot coronavirus vaccine to U.S. regulators Thursday afternoon for emergency use authorization after the vaccine was shown to be robustly effective against illness in a global trial — and especially at preventing severe disease and death.”

Burned by Low Reimbursements, Some Doctors Stop Testing for Covid: “Across the country, some doctors are seeing reimbursement rates so low that they do not cover the cost of the test supplies, jeopardizing access to a tool experts see as crucial to stopping the virus’s spread.”

Swiss medical regulator rejects Oxford/AstraZeneca Covid vaccine: “Switzerland’s medical regulator has said it cannot authorise use of the Oxford/AstraZeneca Covid-19 vaccine based on the available trial data…”

Data privacy startup Skyflow jumps into digital health passport market to help public spaces reopen: “Data privacy startup Skyflow is entering the health care space to provide a way for people to go back to public spaces amid the COVID-19 pandemic with a digital passport.
The company launched Skyflow for Healthcare, which consists of digital passports for COVID-19 and vaccination. Airlines, theme parks and government agencies can use the digital diagnostics and vaccination solution to verify if a person is safe from COVID-19 and ready to enter a public space.”

About pharma

McKinsey Settles for $573 Million Over Role in Opioid Crisis: “McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay $573 million to settle investigations into its role in helping ‘turbocharge’ opioid sales, a rare instance of it being held publicly accountable for its work with clients.
The firm has reached the agreement with attorneys general in 47 states, the District of Columbia and five territories, according to a court filing in Massachusetts on Thursday. The settlement comes after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller amid an opioid crisis in the United States that has contributed to the deaths of more than 450,000 people over the past two decades.”

Roche hit by worst-case biosim assault—to the tune of $5.6B—as COVID-19 hurts new king Ocrevus: “Biosimilars to the three cancer megablockbusters in the U.S., EU and Japan put a CHF 5.05 billion ($5.62 billion) dent in Roche’s top line in 2020, the company said Thursday. The worldwide loss was about CHF 5.7 billion.”

Ken Frazier to retire as Merck CEO after 10-year run, handing the baton to CFO Robert Davis: “The only Black CEO of a Big Pharma company—and one who's spoken out about racial injustice and pandemic promises—is now retiring.
Ken Frazier, who has been Merck & Co.’s chief executive since 2011, will retire June 30, the New Jersey pharma said Thursday. He will continue to serve as executive chairman for a transition period that’s yet to be determined.
Robert Davis, currently Merck’s chief financial officer, will take the reins.”

About health insurance

A number of healthcare organizations issued a joint letter to Congress asking for an extension on the Medicare sequestration moratorium.

UnitedHealth Group CEO Wichmann to retire, Optum chief Witty named successor: “Wichmann has served as CEO of UnitedHealth since 2017 after first joining the company in 1998; he also was previously its chief financial officer.
Witty will take the title immediately and will join the company's board.”
Recall that before joining United, Witty headed up GSK pharmaceuticals fro a number of years.

About hospitals and health systems

Proposed Community Benefit Minimum Spending Floor Notification: Many states have a community benefits standard for purposes of hospital tax-free status. This announcement from the Oregon Health Authority sets a specific dollar minimum for five Legacy System’s hospitals: $252,951,639 for fiscal year 2022. This announcement is a call for comments before implementation.

Today's News and Commentary

About COVID-19

Age groups that sustain resurging COVID-19 epidemics in the United States: “We estimate that as of October 2020, individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one, and that at least 65 of 100 COVID-19 infections originate from individuals aged 20-49 in the US. Targeting interventions – including transmission-blocking vaccines – to adults aged 20-49 is an important consideration in halting resurgent epidemics and preventing COVID-19-attributable deaths.”

White House plans to send millions of vaccine doses to retail pharmacies: “The White House next week will start shipping coronavirus vaccines directly to retail pharmacies alongside ongoing deliveries to states, increasing weekly supplies of shots nationwide to 11.5 million, a top aide said on Tuesday.
U.S. President Joe Biden’s COVID-19 response coordinator, Jeff Zients, said the program will launch on Feb. 11 and will make 1 million doses available to 6,500 stores. As supply grows, the program could expand to as many as 40,000 stores, he said.”

Amazon spreads vaccine misinformation, iSchool researchers find: “Amazon's search algorithm gives preferential treatment to books that promote false claims about vaccines, according to research by UW Information School Ph.D. student Prerna Juneja and Assistant Professor Tanu Mitra.
Meanwhile, books that debunk health misinformation appear lower in Amazon's search results, where they are less likely to be seen, the researchers wrote in a paper that was recently accepted to CHI, the top annual conference on human-computer interaction.”

City of Chicago turns to Zocdoc to help get COVID-19 vaccines into arms: “The city of Chicago is teaming up with Zocdoc to help get COVID-19 vaccines into the arms of its 2.7 million residents.
The online medical appointment booking company will aggregate real-time appointment availability from select Chicago point-of-dispensing sites as well as from local care organizations such as Amita Health and Rush University Medical Center to serve as Chicago's central site for eligible residents to find and book vaccinations, officials from Zocdoc said.
Chicago is the first city to implement Zocdoc's vaccine scheduler tool, a new service care organizations or public health agencies can use, free of charge, to support streamlined vaccine scheduling.”

Oxford coronavirus vaccine shows sustained protection of 76% during the 3-month interval until the second dose: This vaccine is unique in that the booster provides better coverage if delivered three months after the first dose, rather than the 3 weeks with the Moderna and Pfizer vaccines. This finding highlights the need to assess each vaccine separately.

GSK and CureVac to develop vaccines to tackle Covid variants: “The UK’s GlaxoSmithKline and Germany’s CureVac will work together on a new generation of Covid-19 vaccines to tackle emerging variants of the virus that have shown some resistance to existing ones. The two companies have agreed a €150m deal to develop jointly a product using mRNA technology that would work on multiple variants of the Sars-Cov-2 virus and could be ready for use in 2022, subject to approval. GSK will also help manufacture up to 100m doses of CureVac’s mRNA vaccine candidate at its plant in Belgium. The CureVac vaccine, the only mRNA shot that is stable at conventional fridge temperatures, is in the final phases of testing.”

About health insurance

More Americans Choosing Medicare Advantage Plans Amid Pandemic: “Based on preliminary open enrollment data collected from October 15 to December 7, 2020, 36% of the 67.7 million Medicare beneficiaries in the United States are enrolled in a Medicare Advantage (MA) plan this year, marking a 9% year-over-year increase…
While 29% chose the plan for its prescription drug coverage, and 16% for its affordability, 9% of MA enrolled Americans chose it for its supplemental benefits. 
Of those 9%, more than one-third (35%) cited COVID-19 supplemental benefits specifically and 27% referenced its telehealth benefits.”

When will Biden ask the Supreme Court to uphold Obamacare?: “The challenge for Biden's Justice Department is not only telling the justices it manifestly opposes the position taken by the Trump administration in the case, but how to pull off the task. Changing its position on the Affordable Care Act wouldn't end the lawsuit, which was brought by Texas and other Republican-led states, but could inform how the justices look at the case.”

Annual Out-Of-Pocket Spending Clusters Within Short Time Intervals: Implications For Health Care Affordability: The study, based on 2017, data “found that although most commercially insured people had several health care encounters throughout the year, their out-of-pocket spending was mostly concentrated within short time intervals. Nearly one-third of people with above-the-median total annual health care spending (plan plus out-of-pocket spending) incurred half of their annual out-of-pocket spending in just one day.” The purpose of insurance is to protect against catastrophic loss. Perhaps in addition to annual out-of-pocket limits there ought to be a month maximum, or totals spread over months.

Humana Reports Fourth Quarter 2020 Financial Results; Provides Full Year 2021 Financial Guidance: Highlights:
—”Reports 4Q20 loss per common share of $2.07 on a GAAP basis, $2.30 on an Adjusted basis; reports full year (FY) 2020 earnings per diluted common share (EPS) of $25.31 on a GAAP basis, $18.75 on an Adjusted basis (in-line with the company's initial FY 2020 Adjusted EPS guidance as communicated throughout the year)
—Announces FY 2021 EPS guidance in a range of $20.82 to $21.32on a GAAP basis, $21.25 to $21.75 on Adjusted basis; while acknowledging the heightened uncertainty surrounding the ongoing pandemic
—Reaffirms FY 2021 expected individual Medicare Advantage membership growth range of approximately 425,000 to 475,000 members, representing expected year-over-year growth of approximately 11 to 12 percent”

Anthem's pharmacy revenues ballooned in 2020: “While Anthem's fourth-quarter financial results may have disappointed investors, the insurer's in-house pharmacy benefit manager — IngenioRx — saw significant growth in the final quarter of 2020, according to recent financial filings
In the fourth quarter of 2020, IngenioRx recorded revenues of $5.9 billion, up 81.4 percent year over year. Its operating gain for the fourth quarter of 2020 was $363 million, higher than Anthem's combined operating gain for its commercial/specialty and government insurance businesses. For the year ended Dec. 31, 2020, IngenioRx brought in $21.9 billion in revenue, up 305.6 percent from $5.4 billion in 2019.”

About healthcare IT

HIMSS21 still a 'go' for Vegas in August with 400 exhibitors signed up, organizers say: The news is that the planned conference will be in person, not virtual.

FDA names its first medical device cybersecurity director: “The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.
Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall.”

AT&T And U.S. Department of Veterans Affairs Will Pilot Healthcare Innovations With AT&T 5G And Multi-Access Edge Computing: From the AT&T press release of this first-of-kind program:
“AT&T has delivered AT&T 5G capabilities across the entirety of the U.S. Department of Veterans Affairs (VA) Puget Sound Health Care System in Seattle in a public-private partnership with the VA. VA expects to pilot a variety of healthcare use cases with our 5G and multi-access edge computing (MEC ) technologies to explore how they can improve healthcare delivery to the approximately 9 million Veterans who use VA healthcare services each year.
Multi-access edge computing is essentially a computer and cellular network architecture that brings real-time, high-bandwidth, low-latency access to latency dependent mobile applications... Among the healthcare-focused use cases that could be piloted are:

  • Mobile-to-mobile connectivity across/between medical devices, allowing the tracking of people and assets within the facility.

  • Improved medical procedures and training through the use of emerging technologies such as augmented reality (AR) and virtual reality (VR).

  • Remote and virtual pain management using AR and VR.

  • Remote and/or near real-time surgical assistance via the ability to layer multiple surgical techniques using AR.”

 Epic named top overall software suite: 6 insights from 2021 'Best in KLAS' rankings: Not a promotion for Epic. Look at the list in this article and notice a variety of “bests” for different uses.

Today's News and Commentary

About COVID-19

At current supply rate, it would take Kaiser 4+ years to get enough vaccines for all CA patients: The article highlights the vaccine shortage. “Kaiser's CEO says Kaiser cares for 9.3 million Californians and has so far received only 300,000 COVID-19 vaccine doses.”

One-dose COVID-19 vaccine candidate that can be stored at room temperature prompts immunity in animals:”Two vaccine candidates built from gene-therapy technology and developed by Mass General Brigham scientists elicited strong immune responses in mouse and nonhuman primate models, the researchers reported on the journal preprint site bioRxiv. The team received a grant of up to $2.1 million from the Bill & Melinda Gates Foundation to further develop the vaccine technology, called AAVCOVID.
The vaccines, which remain stable when stored at room temperature, use an adeno-associated virus (AAV) vector to deliver genetic sequences of SARS-CoV-2, the virus that causes COVID-19. That generates antigens of the virus’s signature spike protein, in turn prompting an immune response.”

Demographic Characteristics of Persons Vaccinated During the First Month of the COVID-19 Vaccination Program — United States, December 14, 2020–January 14, 2021: “During the first month of the U.S. COVID-19 vaccination program, approximately 13,000,000 persons received ≥1 dose of vaccine. Among persons with demographic data, 63.0% were women, 55.0% were aged ≥50 years, and 60.4% were non-Hispanic White.”

Google Cloud launches vaccine management tools as tech giants jump into distribution efforts: “The company launched artificial intelligence and machine learning tools Monday to help organizations forecast and model COVID-19 cases to better inform vaccine allocation. The cloud-based tools also are designed to assist with vaccine distribution, appointment scheduling, eligibility screening and communications.
The technology, called the Intelligent Vaccine Impact solution, also analyzes consumer sentiment around the COVID-19 vaccine. Understanding how local communities feel about the risks and benefits of the vaccine is critical to being able to increase confidence in vaccination, Google Cloud executives said. The sentiment analysis tool, which was developed in partnership with behavioral intelligence data company Syntasa, will help public health agencies develop a more tailored and informed vaccination campaign.”

A fast, at-home coronavirus test will be available to Americans this year: “The White House announced Monday it is buying 8.5 million rapid coronavirus tests that can be taken at home without a prescription and that yield immediate results.
The $231.8 million contract will allow the Australian company Ellume, which manufacturers the tests, to quickly scale up its production and create a manufacturing facility in the United States. Once running, that factory will be able to produce 19 million tests per month.”

GSK, Clover end COVID-19 vaccine tie-up as Chinese firm advances with Dynavax: “GlaxoSmithKline and Clover Biopharmaceuticals decided to discontinue their COVID-19 vaccine partnership, which was exploring the UK drugmaker's pandemic adjuvant system with Clover's trimeric SARS-CoV-2 spike (S-Trimer) protein-based candidate. On Monday, Clover said it now plans to initiate a global Phase II/III trial of its vaccine adjuvanted with Dynavax's CpG 1018 plus alum in the first half of 2021, with an interim analysis potentially available by mid-year. Shares in Dynavax were up as much as 40% on the news.”

First-to-market Pfizer expects a whopping $15B from its COVID-19 shot in 2021: “More and more COVID-19 vaccines are nearing the market, but mRNA shots from Pfizer and Moderna are still working off a head start in the global rollout. Now, Pfizer has revealed just what that head start could be worth this year.
Short answer: $15 billion. And it could be more.
The company said Tuesday that it's expecting that much in sales from its BioNTech-partnered mRNA shot this year. In last year’s fourth quarter, the vaccine chipped in $154 million.”

About health insurance

Two Youngstown-area physicians indicted for health care fraud and kickback schemes; third charged by bill of information: “At the time of the allegations, Wahib was a Doctor of Osteopathic Medicine and an obstetrics and gynecological (“OBGYN”) specialist; Canby was a Doctor of Osteopathic Medicine and an OBGYN specialist and Kapon was a Doctor of Medicine.  All three physicians were licensed in the State of Ohio and practiced medicine in the Youngstown area.    
According to the indictment, Wahib is accused of conspiring, from March of 2014 through January of 2017, to pay kickbacks to Canby and Kapon to induce them to order gonorrhea and chlamydia testing to be performed by Wahib on specimens of Canby’s and Kapon’s patients. Wahib allegedly then billed and was paid by the federal government for this testing.  Wahib and Canby are also accused of conspiring, through this scheme, to test Canby’s and Wahib’s patients when it was medically unnecessary to do so.”

Higher Medicare Advantage Star Ratings Are Associated With Improvements In Patient Outcomes: The study’s authors “found that enrollees experiencing a one-star MA rating increase were 20.8 percent less likely to voluntarily leave their plan to enroll in another plan or traditional Medicare. When hospitalized, they were 3.4 percent more likely to use a higher-quality hospital and 2.6 percent less likely to be readmitted within ninety days. Our findings suggest that MA star ratings may capture key domains of an MA plan’s quality; however, the differences in outcomes that they capture might not all be clinically meaningful.”

Many Uninsured Adults Have Not Tried to Enroll in Medicaid or Marketplace Coverage: Findings from the September 2020 Coronavirus Tracking Survey: Key findings from this RWJ Foundation study:
—”Just 29.3 percent of uninsured adults tried to obtain Medicaid or CHIP coverage. Most commonly, those who did not try did not think they would qualify.
—Nearly half of all uninsured adults (47.0%) did not look for information on marketplace coverage, nor tried to obtain Medicaid or CHIP coverage.
—About half of uninsured adults (53.9%) heard a lot or some about the marketplaces; just under two-thirds (64.9%) heard nothing or only a little about financial assistance for marketplace coverage.
—Almost half of uninsured adults familiar with marketplace plans did not look for information on them, most commonly because of cost concerns.”

About pharma

Controlling Pain After Surgery Doesn’t Have to Mean Opioids, Study Shows: “Comparison of opioid-sparing approach with standard care shows no difference in patient satisfaction, but less pain among those counseled to use opioids only as backup.”

Judge Rules Against HHS Attempt to Stop Gilead Sciences’ Counterclaims for HIV Patents: “A federal judge in Delaware has ruled that the U.S. government can’t block a lawsuit by Gilead Sciences, which asserts that four HHS patents for HIV drugs are invalid.
In an initial lawsuit, HHS alleged that HIV drugs developed by Gilead infringe on its patents, including for Truvada (emtricitabine/ tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide). But Gilead argues in a counter-lawsuit that data used to develop the drugs came from a collaboration with HHS and that the federal government had not disclosed that it was seeking the patents.”

About healthcare personnel

100 Best Jobs: Skim this list…it is remarkable how many jobs are in the healthcare sector.

About health systems

HCA Healthcare Reports Fourth Quarter 2020 Results and Provides 2021 Guidance: “Key fourth quarter metrics (all percentage changes compare 4Q 2020 to 4Q 2019 unless otherwise noted):

  • Revenues totaled $14.293 billion

  • Net income attributable to HCA Healthcare, Inc. totaled $1.426 billion, or $4.13 per diluted share

  • Adjusted EBITDA totaled $3.118 billion

  • Cash flows used in operating activities totaled $3.583 billion (includes the return, or early repayment, of over $6 billion in CARES Act funds)

  • Same facility admissions and same facility equivalent admissions declined 3.4 percent and 7.5 percent, respectively”

About healthcare IT

Health tech funding snapshot—Paige nets $100M; TimelyMD banks $60M to expand teletherapy for college students: A good update about recent tech funding.

Nebraska Health Information Exchange Joins SDOH Data Group: “CyncHealth (formerly NEHII, or the Nebraska Health Information Initiative), the state’s health information exchange, has joined the Gravity Project, a community-led HL7 Fast Healthcare Interoperability Resources (FHIR) Accelerator, to enhance social determinants of health (SDOH) data interoperability across its platform.
The Gravity Project is a new community-led effort to develop national standards for SDOH data exchange. It aims to grow a diverse community of healthcare professionals to identify and review terminologies, conduct a gap analysis, and advance recommendations to address the disparities using nationally recognized data standards…
The Gravity Project initially focused on basic SDOH data, such as food insecurity, housing insecurity, and transportation insecurity. However, through its partnership with CyncHealth, the Gravity Project is expanding its coverage to financial strain, material hardship, stress, social isolation, and demographic attributes.
Founded by the University of California San Francisco (UCSF) Social Interventions Research and Evaluation Network (SIREN) in 2018, the Gravity Project consists of over 1,000 healthcare stakeholders.”

Today's News and Commentary

About COVID-19

An antibody that clamps onto the COVID virus’s ‘Achilles heel’: “Laura Walker at the biopharmaceutical company Adimab in Lebanon, New Hampshire, and her colleagues isolated antibodies from the immune cells of a person who had recovered from a 2003 infection with the virus SARS-CoV, which is related to SARS-CoV-2 (C. G. Rappazzo et alScience https://doi.org/fsbc; 2021). By tinkering with the structure of the antibodies, the researchers created one, called ADG-2, that was particularly effective at disabling SARS-CoV-2 in a lab dish.
The engineered antibody also disabled a variety of related coronaviruses.When given to mice, it stopped SARS-CoV-2 from reproducing in the rodents’ lungs and protected the animals from respiratory disease.”

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC: “Moderna has asked the U.S. Food and Drug Administration for permission to fill its Covid-19 vaccine vials with up to five additional doses to ease a bottleneck in manufacturing, according to a person familiar with the matter.
The change would allow Moderna to put 15 doses in the same size vials now cleared to hold 10, alleviating pressure on the part of the manufacturing process known as fill/finish, said the person, who declined to be named because the application isn’t yet public.”

Eli Lilly antibody treatment ineffective against South Africa coronavirus variant, study says: “Eli Lilly's COVID-19 monoclonal antibody treatment, bamlanivimab, is ineffective in treating patients infected with B.1.351, the novel coronavirus variant first identified in South Africa, according to a study published Jan. 28 in the medical preprint server bioRxiv.
The drugmaker also tested its antibody treatment against, B.1.1.7, the variant first identified in the U.K., finding it to be just as effective as it had been against earlier versions of the novel coronavirus.CDC issues sweeping mask mandate for planes, public transportation in U.S.: “Masks must be worn at train and subway stations, bus terminals and airports nationwide, as well as on planes, trains and other types of public transportation in the United States, according to a far-reaching federal public health order issued late Friday.
The order, which will take effect at 11:59 p.m. Monday, adds details to the mandate President Biden signed on his first full day in office.”

Daily Covid Toll in U.S. Remains Enormous, but Cases Are Falling: “The past few weeks in the United States have been the deadliest of the coronavirus pandemic, and residents in a majority of counties remain at an extremely high risk of contracting the virus. At the same time, transmission seems to be slowing throughout the country, with the number of new average cases 40 percent lower on Jan. 29 than at the U.S. peak three weeks earlier.” The article has useful, updated graphics.

Vaccine Monitor: Nearly Half of the Public Wants to Get a COVID-19 Vaccine as Soon as They Can or Has Already Been Vaccinated, Up across Racial and Ethnic Groups Since December: From the Kaiser Family Foundation. Interesting updates, including breakdown of who is most likely to want the COVID-19 vaccine and what messages are more effective in motivating people to get vaccinated. The top two: The vaccines are highly effective in preventing illness: 57 percent and The vaccine will protect you from getting sick: 56 percent.


About pharma

Magellan Rx Medical Pharmacy Solution Impact: 90% of New Authorizations for Oncology Biosimilars: “Magellan Rx Management, a division of Magellan Health, Inc., today released preliminary results from its oncology biosimilar medical pharmacy solution that targets new-to-market oncology therapeutic biosimilars….As of May 2020, health plan customers who…partner with Magellan Rx have achieved a 90% rate for authorization for the first two therapies with biosimilar availability.”

About hospitals and health systems

6 health systems opening hospitals: Despite COVID-19 challenges, this trend continues.

About health financing

Lyra Health now worth $2.3B on heels of massive funding round:Spurred by the demand for mental health services during the pandemic,[emphasis added] Lyra Health is now worth more than $2 billion.
The startup scored $187 million in new financing as it looks to expand its services and bring more technology to its platform.
The Burlingame, California-based company, which provides mental health benefits for large employers, has more than doubled its customer base in 2020 and extended its services to support more than 2 million members..”

About the public’s health

Americans can’t cut back on salt. One likely reason: Packaged and prepared foods are filled with it.: As more people are eating at home, and have more control over what they eat, this article is a good reminder about another health hazard—this one is easy to address. “Even though the vast majority of public health experts regard too much salt as a killer and urge you to do whatever you can to cut back, Americans find that difficult. One reason is that more than 70 percent of salt in the American diet comes from packaged and prepared foods, according to the Food and Drug Administration, not from the salt shaker at home.”

About health insurance

Cigna Master Precertification list: The news media picked up on the change that some cardiac imaging tests (like CT angiography) no longer require precertification; however, this list is a good reminder of the interventions that still require review.

MACPAC wants Congress to automatically boost FMAP during recessions:  ”Medicaid and CHIP Payment and Access Commission on Friday voted to recommend that Congress automatically increase the federal share of Medicaid spending during recessions.
Under the policy, the federal government would temporarily raise the Federal Medical Assistance Percentage based on increases in state unemployment and reductions in total wages and salaries, rather than requiring Congress to approve each increase as it does now.”
MACPAC can only recommend policies to Congress.

Health insurer helps fund Bronzeville [Chicago neighborhood] affordable housing: “UnitedHealth Group is providing $15.4 million—more than half the total cost—for the construction of a 53-unit building of affordable apartments in the Bronzeville neighborhood. The project, 508 Pershing at Oakwood Shores, is being developed the Community Builders, a nonprofit…”

About healthcare IT

More than 900K health records breached in January: As long as these frequent and large breaches occur, the public is not likely to support true interoperability.

Today's News and Commentary

BHI [Blue Health Intelligence] 2020 Year-end data Digest: Worth a look for some year-end trends. Among the findings:

  • “Men faced several health challenges in 2019, and, in many cases, had significantly higher rates of disease than women. Higher rates of alcohol abuse, opioid abuse, and nicotine dependence were observed in all age groups of men 19 and older.

  • Obesity increased in both adults and children from 2016-2019. Children ages 2-4 showed the highest annual increase (20.6%). “Childhood obesity puts children at increased risk of cardiac disease, diabetes, breathing difficulties, joint and musculoskeletal discomfort, and gastrointestinal issues,” the report notes. “Being overweight also can result in social and psychological problems such as low self-esteem, anxiety, and depression.”

  • Skin cancer and melanoma rates differ widely from state to state, and not always in the expected ways. Typically, warmer and sunnier states have higher rates of skin cancer, but in 2019, rates for Maine, Massachusetts, and Pennsylvania were higher than the southern states of Texas and Louisiana. Of note, Hawaii and Alaska – two states at opposite ends of the weather spectrum – shared the lowest rate of melanoma.

  • HPV played a significant role in the higher rates of certain cancers in men, which are linked to men’s higher use of nicotine and alcohol. On a positive note, BHI found the rate of HPV vaccination rose 7.8 percentage points for males from 2016 through 2019, compared with 5.9 percentage points for females.

  • Telehealth skyrocketed in the first nine months of 2020. BHI specifically noted a 50-fold increase in the utilization of virtual healthcare services by commercially insured individuals from March 2019 to March 2020 and a 100-fold increase from April 2019 to April 2020.”

About health insurance

Hospitals get ‘raw deal as CMS rejects site-neutral pay cut exemptions: “CMS may claw back millions of dollars in payments after the agency denied reimbursement rate cut exemptions for hospitals' off-campus outpatient facilities. CMS rejected more than 60% of the mid-build exceptions, which would preserve hospitals' higher reimbursement rates if they had the documentation to prove their off-campus outpatient departments were being constructed when the Bipartisan Budget Act was passed in 2015.”

About Covid-19

U.S. handling of American evacuees from Wuhan increased coronavirus risks, watchdog finds: “As the first American evacuees from Wuhan, China, touched down at a California military base a year ago, fleeing the epicenter of the coronavirus outbreak, they were met by U.S. health officials with no virus prevention plan or infection-control training — and who had not even been told to wear masks, according to a federal investigation.
Later, those officials were told to remove protective gear when meeting with the evacuees to avoid ‘bad optics,’ and days after those initial encounters, departed California aboard commercial airline flights to other destinations.”

J&J Vaccine Provides Strong Shield Against Severe Covid: “In a study of more than 43,000 people, the vaccine prevented 66% of moderate to severe cases of Covid-19, according to a company statement Friday. And it was particularly effective at stopping severe disease, preventing 85% of severe infections and 100% of hospitalizations and deaths.” While not as high a prevention rate as Moderna and Pfizer products, it can be produced in very large quantities, only requires a single dose and does not have the same handling (refrigeration) limitations as do the other two vaccines.

Novavax vaccine almost 90 percent effective in trial, but not against South Africa variant: “Efficacy was strong in the U.K. trial, at 89.3 percent, the company said. But in a separate, smaller trial in South Africa, where a more contagious variant of the virus has taken hold, efficacy fell sharply to 49.4 percent, though it was somewhat higher, at 60 percent, among participants who did not have HIV.”

German authorities recommend against use of AstraZeneca's COVID-19 vaccine in over-65s: “The recommendation, which supports use in adults between 18 and 64 years, follows reports earlier in the week from German media outlets that the efficacy of AstraZeneca's vaccine was only 8% effective in people over 65. AstraZeneca called the reports ‘completely incorrect,’ while the German health ministry has also since refuted the claims.”

AstraZeneca's COVID-19 shot scores European authorization as production holdups linger: “The vaccine, the result of AZ's collaboration with Oxford University, is conditionally approved across Europe in people ages 18 and older. A broad rollout in EU member countries will follow, but in recent days, a reduction in first-quarter supply has dominated headlines.”

About pharma

In a win for PBMs, Biden administration delays rebate rule: “The Department of Health and Human Services has pushed back the start date for the rule, which was set to take effect on Friday, to March 22. The regulation, revived by President Donald Trump's HHS late last year, would replace protections for drug rebates in Medicare Part D with protections for discounts provided directly to consumers.”

Merck’s Keytruda Nabs EU Approval for Colorectal Cancers: “The approval is for first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.”

McKinsey in advanced talks with US states to settle opioid claims: “McKinsey is in advanced discussions with several US states’ attorneys-general to pay hundreds of millions of dollars to settle civil claims about its role in advising drug companies held responsible for the country’s opioid epidemic…
The consultancy firm has previously apologised for its role in trying to boost sales of OxyContin. Last year, it said its work with Purdue was designed to support legal prescription of opioids for patients with ‘legitimate medical needs.’”

About healthcare quality

Patient Safety Watchdog The Leapfrog Group Funded for National Initiative on Preventing Harm from Diagnostic Error: “The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on patient safety and quality, today announced Recognizing Excellence in Diagnosis, a new national initiative to publicly report and recognize hospitals for preventing patient harm due to diagnostic errors. Developed in collaboration with The Society to Improve Diagnosis in Medicine (SIDM) and key experts, the project is funded with a two-year grant of $1.2 million by the Gordon and Betty Moore Foundation.” Disclosure: I am on SIDM’s finance committee.

Hospitals agree to follow higher quality standards to get more money from Medicaid, which covers 1/3 of state's population: “With up to 28 rural Kentucky hospitals vulnerable to closure if their finance don't improve, Tuesday's announcement of a new payment model to increase the amount Kentucky's hospitals are paid for Medicaid patients is cause for their celebration…
In order to receive these funds, hospitals will have to abide by higher quality standards that are still being decided by KHA [Kentucky Hospital Association] and the Cabinet for Health and Family Services. Quality standards include things like hospital-acquired infections, medication errors and readmission rates.”

Association of Graduate Medical Education [GME] With Hospital Performance and Patient Outcomes: “This study found a negative linear correlation between GME funding and patient mortality and a positive correlation between GME funding and resident BCE [Board Certification Examination] pass rates in adjusted regression models. The findings also suggest that hospitals that receive more GME funding are not more financially stable.”

Allocation of National Institutes of Health Funding by Disease Category in 2008 and 2019: “In this study, NIH spending for most diseases seemed to be based primarily on the level of NIH spending more than 10 years earlier, despite changes in burden of disease. Congress and the NIH should examine the allocation process to ensure NIH investments are responsive to changes in the health of the population.”

About healthcare IT

Florida Medicaid website hacked for 7 years, hundreds of thousands affected: “Tallahassee-based children Medicaid health plan Florida Healthy Kids Corp. began notifying members Jan. 27 of a 7-year data breach that exposed the personal information of hundreds of thousands of  health plan applicants. 
The health plan was notified Dec. 9 of the security breach  and launched an investigation, which found there had been "significant vulnerabilities" since 2013 on its website and databases that support the online children health insurance application. The vulnerabilities lasted from November 2013 to December 2020, when the health plan temporarily shut down its website. 
The health plan said it discovered that several thousand applicants' information was inappropriately accessed and tampered with as a result of the breach. Information of applicants and enrollees that was exposed included Social Security numbers, dates of birth, names, addresses and financial information.”

22 Million U.S. Seniors Lack Broadband Internet Access; First Time Study Quantifies Digital Isolation of Older Americans as Pandemic Continues to Ravage Nation: The headline speaks for itself. More details, including the full report are in the article.

Today's News and Commentary

About COVID-19

Coronavirus variant first seen in South Africa identified in South Carolina: “The highly transmissible variant of the coronavirus first identified in South Africa has infected two people in South Carolina with no travel history, state officials announced Thursday. These are the first cases in the United States involving the B. 1.351 variant, and the patients’ lack of travel suggests the variant is already spreading in the community following an undetected introduction.”

Novartis says it's ready to pitch in on manufacturing rivals' COVID-19 vaccines, diagnostics: “Right after Sanofi stepped in to help produce Pfizer/BioNTech coronavirus vaccines in Europe, Novartis is exploring whether it can deploy its own manufacturing network to boost COVID-19 supplies. Separately, the U.S. is weighing the Defense Production Act to compel drugmakers to produce Pfizer or Moderna mRNA vaccines.”

How Covid-19 mutations are changing the pandemic: A good summary about what the mutations are and how they will affect control efforts.

China rolls out anal swab coronavirus test, saying it’s more accurate than throat method: “Chinese state media outlets introduced the new protocol in recent days, prompting widespread discussion and some outrage. Some Chinese doctors say the science is there. Recovering patients, they say, have continued to test positive through samples from the lower digestive tract days after nasal and throat swabs came back negative.”

Time to double or upgrade masks as coronavirus variants emerge, experts say: “The discovery of highly transmissible coronavirus variants in the United States has public health experts urging Americans to upgrade the simple cloth masks that have become a staple shield during the pandemic.
The change can be as simple as slapping a second mask over the one you already wear, or better yet, donning a fabric mask on top of a surgical mask. Some experts say it is time to buy the highest-quality KN95 or N95 masks that officials hoping to reserve supplies for health-care workers have long discouraged Americans from purchasing.”

About healthcare quality

Measuring Patient Experience of Medicare Advantage Beneficiaries: From a study conducted by NORC at the University of Chicago that was commissioned by Better Medicare Alliance/Center for Innovation in Medicare Advantage Policy
”Recommendations:
—Modernize patient experience measurement in MA by updating the survey language to reflect the diversity of today’s beneficiaries, along with the evolution of MA benefit offerings and how care is delivered today.

—Provide more granular CAHPS results to health plans while protecting beneficiary confidentiality to empower better health plan quality improvement.

—Remove MA-PD CAHPS questions from the patient experience MA Star Ratings that health plans cannot directly impact, and increase the patient experience MA Star Ratings weights from two to four, only after changes are made to modernize MA patient experience measurement.

—Explore ways to reduce burden on the beneficiary survey respondent to improve response rates. Tactics to achieve this goal include:

  • Reduce the length of the survey by removing provider-focused questions that sit outside the control of the health plan

  • Help respondents orient to the patient experiences the survey seeks to measure

  • Use appropriate financial incentives to encourage participation

  • Pilot a web-mode option

  • TestnovelCAHPSscoringapproachesthatleverageproviderCAHPS data, which, if successful, can facilitate a reduction in survey length”

Primary care docs make up minority of spending on low-value care, study finds: “Low-value spending—that is, costs incurred for services that experts in the field agree aren't very valuable—is less likely to occur due to primary care docs compared to other physicians, a new research report concluded…
[T]he research report found, for the majority of primary care docs, services performed or ordered accounted for less than 9% of their patients’ low-value spending. That amounted to less than 0.3% of their total Medicare Part B spending.
Most primary care physician referrals accounted for less than 16% of their patient's low-value spending or less than 0.5% of their total Medicare Part B spending.”

The Joint Commission and Joint Commission Resources launch new data transparency initiative for health care organizations: “The Joint Commission and Joint Commission Resources (JCR), Inc. today announced a new data transparency initiative – DASH™ (Data Analytics for Safe Healthcare). The initiative offers three business intelligence tools in the form of dashboards and performance improvement resources to power customers’ performance improvement efforts on their journey to zero harm.  
The three business intelligence tools include:  

  • Accelerate PI (The Joint Commission): Provides data on quality measures selected because of their validity, importance and known evidence-based improvement strategies. Compares an organization to national, state and Joint Commission accredited organization averages.

  • SAFER™ Dashboard (The Joint Commission): Presents the findings from accreditation survey reports in a dashboard to empower timely, data-driven decisions that drive the delivery of safe, high-quality care.

  • Illuminate Analytics (JCR): Offers greater visibility on the collective performance of a JCR customer to help draw meaningful, actionable conclusions from disparate data sources (i.e. Tracers with AMP® and consulting data).”

Top 10 health technology hazards for 2021, ranked by ECRI Institute:

“1. Emergency use authorization device management: Complexity of managing medical devices with COVID-19 EUAs.  

2. Drug name auto-display: Drug entry fields that populate after only a few letters can cause fatal medication errors. 

3. Telehealth adoption: Rapid roll-outs of virtual care technologies may leave patients' data at risk. 

4. Imported N95-style masks: May fail to protect healthcare workers from infectious respiratory diseases. 

5. Consumer-grade devices: Relying on these products can lead to inappropriate healthcare decisions. 

6. UV disinfection: Quick deployments of UV disinfection devices can reduce effectiveness and increase exposure risks. 

7. Software vulnerabilities: Weaknesses in third-party software components present cybersecurity challenges. 

8. Artificial intelligence in diagnostic imaging: These technologies may misrepresent certain patient populations. 

9. Remote operation risks: Remotely operating medical devices designed for bedside use introduces new risks. 

10. 3D printing quality: Lack of quality assurance of 3D-printed patient medical devices may harm patients. 
Click here to view the full report.”

About health insurance

Medicaid Expansion Would Have a Larger Impact Than Ever during the COVID-19 Pandemic: From the Urban Institute: “As of December 2020, 36 states and the District of Columbia had expanded Medicaid eligibility under the Affordable Care Act (ACA). We find that if the remaining 14 states had expanded eligibility in 2020, 4.4 million fewer people would have been uninsured that year. Absent the COVID-19 pandemic, the difference would have been 3.8 million. Thus, Medicaid expansion in the remaining states would increase health coverage even more under the pandemic. We also find young adults have the highest uninsurance rates under current law and would gain more coverage from Medicaid expansion than any other age group. And though further expansion would not increase the already high Medicaid eligibility thresholds for children, more children would be enrolled as their parents seek such coverage.”

17 States Back Trump's Medicaid Work Requirements Revival: “A coalition of 17 state attorneys general urged the U. S. Supreme Court to reject a lower court's decisions barring the Trump administration's revival of a pilot project that would allow Arkansas and New Hampshire to impose work requirements in Medicaid programs. In a 42-page amicus brief filed Tuesday, the attorneys general argue that although the suit's current focus is on imposing work requirements on Medicaid recipients, allowing the D. C. Circuit's decision to stand could jeopardize the validity of other waiver programs that millions of Americans rely on.”

About healthcare IT

Artificial Intelligence (AI) Strategy: From HHS, this document outlines an approach to managing AI:
Together with its partners in academia, industry and government, HHS will leverage AI to solve previously unsolvable problems by continuing to lead advances in the health and wellbeing of the American people, responding to the use of AI across the health and human services ecosystem, and scaling trustworthy AI adoption across the Department.”
Check Fig 3.2 on page 7.

About pharma

International Prescription Drug Price Comparisons: Here is the summary findings from this RAND report:

“Prices in the United States are higher than those in all comparison countries

  • U.S. prices were 256 percent of those in the 32 comparison countries combined.

  • In comparisons with individual countries, U.S. prices ranged from 170 percent of prices in Mexico to 779 percent of prices in Turkey.

  • The gap between U.S. prices and prices in other countries was larger for brand-name originator drugs.

  • U.S. prices were 84 percent of prices in all non-U.S. countries for unbranded generics.

  • U.S. prices were 190 percent of prices in other countries after adjusting U.S. prices downward to account for rebates and other discounts.”

Biden kills Trump plan on opioid-treatment prescriptions: “The Biden administration said Wednesday that it is canceling a last-minute plan by the Trump administration to let more physicians prescribe an opioid-treatment drug, despite exhortations from lawmakers and physician groups to keep it….
The Trump administration’s plan was plagued by legal and operational problems, including a failure to get necessary clearance from the White House budget office, said two officials who spoke on the condition of anonymity because they were not authorized to discuss it.
’The Biden-Harris administration absolutely supports broader access to medication-based treatment for opioid use disorder, and is working to find ways to lift burdensome restrictions on medications for opioid use disorder treatment,’ said a spokesperson for the White House’s drug policy office.”

Today's News and Commentary

About COVID-19

Sanofi, after R&D setback, lends a hand to vaccine rival Pfizer for coronavirus shot production “Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing.”

Biden administration aims to have enough vaccine for most Americans by summertime: “Biden’s administration will purchase 100 million doses each of the vaccines made by Pfizer Inc and BioNTech, and Moderna Inc, increasing the overall total doses to 600 million, with delivery expected by summer.
The previous purchase target was 400 million doses.”

Google Maps will soon display Covid-19 vaccination sites: ”The feature is rolling out in the coming weeks, beginning in four states: Arizona, Louisiana, Mississippi and Texas…
The results, which will also be shown in search results in designated information panels, include details about whether an appointment is required, if the vaccine is only available to certain groups and if there's a drive-thru. Google said it's working with ‘authoritative sources’ for the information, including local governments and retail pharmacies. Information about vaccine sites will roll out to other states and countries later.”

Eli Lilly says antibody combo significantly cuts COVID-19 death risk: “The results from a final-stage clinical trial of more than 1,000 patients testing the combination of bamlanivimab and etesevimab found just 11 hospitalizations in patients taking the therapy, compared to 36 events in patients taking a placebo, a 70 percent reduction compared to a placebo.
There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.
Lilly said the trial also demonstrated ‘strong evidence that the therapy reduced viral load and accelerated symptom resolution.’
…The announcement comes just days after Lilly reported that treatment with bamlanivimab alone cut nursing home staff and residents’ risk of developing symptomatic COVID-19 infections by 57 percent against placebo. 
With the new data, Lilly could ask the Food and Drug Administration to authorize the treatment as a preventive measure. Currently, bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in high-risk patients.”

Biden says he’s ‘bringing back the pros’ for virus briefings: “Beginning Wednesday, administration experts will host briefings three times a week on the state of the outbreak, efforts to control it and the race to deliver vaccines and therapeutics to end it…
Wednesday’s briefing will be conducted virtually, rather than in person at the White House, to allow for questions from health journalists and to maintain a set timing no matter the schedule in the West Wing. It will feature Jeff Zients, the Biden administration’s coordinator for pandemic response; his deputy, Andy Slavitt; Fauci; Dr. Marcella Nunez-Smith, the chair of Biden’s COVID-19 equality task force; and Dr. Rochelle Walensky, the director of the CDC.” Here is a link to today’s briefing from a hour ago..

FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers: “As part of the U.S. Food and Drug Administration… has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.”

COVID-19 Clinical management: living guidance: The latest update from WHO has 5 new conditional recommendations, including: “A conditional recommendation for use of pulse oximetry monitoring at home as part of a package of care…”

UI researchers develop quicker method of antibody testing: “Researchers at the University of Illinois have developed a new way to test for antibodies. This can give people results in just 15 minutes. This one only needs a drop of blood. The other ones require more than that.
This blood sample also doesn’t have to be sent away to another lab for testing and can be processed on-site. Each tests only costs $2 to perform. One of the reasons this new method is important is because it will allow people who’ve had the COVID-19 vaccine to see how well it worked.”

Data and Policy to Guide Opening Schools Safely to Limit the Spread of SARS-CoV-2 Infection: The CDC says that preventive measures in K-12 are largely working and should be continued: “…the preponderance of available evidence from the fall school semester has been reassuring insofar as the type of rapid spread that was frequently observed in congregate living facilities or high-density worksites has not been reported in education settings in schools.”
However, “…some school-related activities have increased the risk of SARS-CoV-2 transmission among students and staff. Numerous media reports of COVID-19 outbreaks among US high school athletic teams suggest that contact during both practices and competition, and at social gatherings associated with team sports, increase risk.”

Large majorities of the region’s nursing home workers have declined the coronavirus vaccine: “A large percentage of nursing home workers in D.C., Maryland and Virginia have declined to take the coronavirus vaccine, officials say, presenting a major challenge in the region’s plans to protect its most vulnerable residents…
In an internal document obtained by The Washington Post, Maryland health officials said that as of Tuesday, only about 58 percent of the doses allocated to nursing home staff and residents had been administered — even though vaccination clinics have been conducted at every facility. Tredonna Kum, an administrative organizer for 1199 SEIU, which represents nursing home workers in Maryland and D.C., estimated that up to 80 percent of members chose not to be vaccinated during the first wave of clinics…
In North Carolina, the top public health official said in early January that most nursing home workers had declined the vaccine. In Ohio, more than 60 percent of nursing home workers opted out during the first wave of vaccination clinics, said Gov. Mike DeWine (R). Officials in Connecticut have reported similar numbers. 
David Grabowski, a Harvard University health policy professor, said the numbers shouldn’t surprise anyone familiar with long-term care facilities, where low wages and poor labor conditions — and earlier missteps fighting the coronavirus pandemic — have created a well of mistrust, especially among the Black and Latino workers who dominate the industry.”

Make the air in your home safer during COVID-19 by increasing ventilation and filtration: A useful infographic on ventilation and filtration procedures for the home..

HCA Healthcare forms consortium with AHRQ and research institutions to accelerate COVID-19 research: “HCA Healthcare is proud to announce that we’ve formed a consortium of prominent public and private research institutions to use HCA Healthcare’s vast data on COVID-19 hospital care to improve patient outcomes and public knowledge. The institutions – including the federal Agency for Health Research and Quality (AHRQ), Johns Hopkins University, Duke University, Meharry Medical College, Harvard Pilgrim Health Care Institute, and others – will gain access to the data in a research program directed by the HCA Healthcare Research Institute (HRI).”

About health insurance

Anthem Reports Fourth Quarter and Full Year 2020 Results: The company report starts with a long list of initiatives before financial performance is presented. In short, 2020 4th Q profit was $551 million, a 41% decrease compared to the same period in 2019. Earnings for the full year were $4.6 billion compared to $4.8 billion in 2019.

Federal action on surprise medical bills: What doctors should know: This article from the AMA is a good summary of the surprise billing provisions (not just for physicians).
”Patient protections included in the No Surprises Act include:

  • A provision that patients may not be billed beyond the recognized in-network cost-sharing amount.

  • If a patient relies on erroneous network directory information to choose a physician, the plan cannot impose a cost-sharing amount greater than in-network rates and it must count toward the patient’s in-network out-of-pocket-maximum and in-network deductible.

  • Unless notice and consent requirements are met in non-emergency situations, if a provider submits a bill to a patient in excess of in-network cost sharing and the patient pays, the provider must refund with interest.

  • If a provider contract is terminated without cause, a “continuing patient” can continue for either 90 days or the date when no longer a continuing patient, whichever is earlier.”

Partners in Primary Care Announces 2021 Growth Plans for Its Senior-Focused Care Facilities: “ Partners in Primary Care announced… the details of its 2021 expansion. Having opened 15 new centers in 2020, plans for 2021 include up to 20 more centers, including entering the Atlanta market, additional centers in the Houston area and five more in Louisiana, including Lafayette and the North Shore outside of New Orleans as well as two new centers in Nevada.
The planned center openings will bring the total number of centers Partners in Primary Care operates (including its Orlando, Florida-based Family Physicians Group facilities) to nearly 80 centers. By 2023, Partners in Primary Care expects to operate approximately 100 centers.”
Partners in Primary Care is a payer-agnostic subsidiary of Humana Inc. focused on primary care for seniors. About healthcare IT

Ransomware Activity Targeting the Healthcare and Public Health Sector: “This joint cybersecurity advisory was coauthored by the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS). This advisory describes the tactics, techniques, and procedures (TTPs) used by cybercriminals against targets in the Healthcare and Public Health (HPH) Sector to infect systems with ransomware, notably Ryuk and Conti, for financial gain.”
One non-technical finding is that stealing medical chart information for fraudulent billing is far more profitable than stealing credit card and other similar personal data.
And in a related article: 13 healthcare provider malware, ransomware and phishing incidents for January.

Trends in EMR Interoperability: From The College of Healthcare Information Management Executives (CHIME) and KLAS Research, this report is an up-to-date survey of the state of EMR interoperability. While rates have doubled over the last 3 years, there is still a long way to go to make sure systems achieve their full potential. Included in this study is use of FHIR.
About health professionals

January 2021 Physician Flash Report: From KaufmanHall: “Although physician practices saw some gains in the third quarter of 2020, most performance measures remained well below 2019 levels. Many practices saw an uptick in productivity and revenues in the late summer and early fall with the easing of social distancing policies and limits on non-urgent care .
As a result, health systems experienced a 9 .5% decrease in the level of investment needed to subsidize inadequate physician revenues between July and October 2020, with the median Subsidy per Physician Full-Time Equivalent (FTE) dropping to $194,632 across all specialties. Year-over-year, Subsidy per Physician FTE was up just 0.5% in October, after climbing 14.1% year-over-year from January to July—reflecting the effects of sizable volume and revenue swings brought about by the COVID-19 crisis .
After suffering significant declines early in the pandemic, many organizations saw volumes rebound somewhat by October. This enabled an increase in physician productivity.”

About the public’s health

Millions earmarked for public health emergencies were used to pay for unrelated projects, inspector general says: “Federal officials repeatedly raided a fund earmarked for biomedical research in the years leading up to the covid-19 pandemic, spending millions of dollars on unrelated salaries, administrative expenses and even the cost of removing office furniture, according to the findings of an investigation into a whistleblower complaint shared with The Washington Post.
The investigation, conducted by the inspector general of the Department of Health and Human Services and overseen by the Office of Special Counsel, centered on hundreds of millions of dollars intended for the development of vaccines, drugs and therapies by the Biomedical Advanced Research and Development Authority or BARDA, an arm of the federal health department.
The unidentified whistleblower alleged that officials in the office of the assistant secretary for preparedness and response at HHS, which oversaw the biomedical agency, wrongly dipped into the money set aside by Congress for development of lifesaving medicines, beginning in fiscal 2010 and continuing through at least fiscal 2019, spanning both the Obama and Trump administrations.”

National Obesity Monitor: The Adult Obesity Rate (ages 20+) for 2017-2018 was 42.4% and the Youth Obesity Rate (ages 2-19) for 2017-2018 was 19.3%, a record high.

Today's News and Commentary

About COVID-19

U.S. new COVID cases down 21% in past week, deaths fall from peak: “The United States reported a 21% drop in new cases of COVID-19 last week, as all but one state reported declines in new infections, and the number of coronavirus patients in hospitals also fell.
The country reported 1.2 million new cases in the week ended Jan. 24, down from 1.5 million new cases in the previous week. It was the biggest decline on both a percentage and absolute basis in the past year, according to a Reuters analysis of state and county reports.”

Disgraced COVID-19 studies are still routinely cited: “In June 2020, in the biggest research scandal of the pandemic so far, two of the most important medical journals each retracted a high-profile study of COVID-19 patients. Thousands of news articles, tweets, and scholarly commentaries highlighted the scandal, yet many researchers apparently failed to notice. In an examination of the most recent 200 academic articles published in 2020 that cite those papers, Science found that more than half—including many in leading journals—used the disgraced papers to support scientific findings and failed to note the retractions…
Both of the retracted COVID-19 papers, one in The New England Journal of Medicine (NEJM) and the other in The Lancet, were based on what appeared to be a huge database of patient records compiled from hospitals worldwide by Surgisphere, a small company operated by vascular surgeon Sapan Desai, who was a co-author on each article. The 22 May 2020 Lancet paper ostensibly showed that hydroxychloroquine, an antimalarial drug promoted by former President Donald Trump and others, could harm rather than help COVID-19 patients. Its publication led to a temporary halt in a major clinical trial and inflamed an already-divisive debate over the drug, which has proved to be useless against COVID-19. The 1 May NEJM article corroborated other evidence that people already taking certain blood pressure medicines did not face a greater risk of death if they developed COVID-19.”

White House expected to tell governors they will get more coronavirus vaccine starting next week: “The weekly allocation is forecast to go from about 8.6 million doses to about 10 million doses. The vaccine is distributed on a population basis among 64 jurisdictions, including 50 states, eight territories and six major cities.” And in a related story: Biden says 100-day goal on vaccinations may rise to 150 million instead of 100 million

Johnson & Johnson is 'comfortable' meeting coronavirus vaccine delivery promises, CFO says: “J&J expects to report phase 3 data for its one-dose vaccine by early next week, execs said Tuesday.”

Amid Covid Health Worker Shortage, Foreign-Trained Professionals Sit on Sidelines:”Yet a large, highly skilled workforce of foreign-educated doctors, nurses and other health practitioners is going largely untapped due to licensing and credentialing barriers. According to the Migration Policy Institute think tank in Washington, D.C., some 165,000 foreign-trained immigrants in the U.S. hold degrees in health-related fields but are unemployed or underemployed in the midst of the health crisis.”

Study shows vaccine nationalism could cost rich countries US$4.5 trillion: “A new study commissioned by the ICC [International Chamber of Commerce] Foundation has found that the global economy stands to lose as much as $9.2 trillion if governments fail to ensure developing economy access to COVID-19 vaccines, as much as half of which would fall on advanced economies.
The study clearly demonstrates the economic case to invest in the Access to COVID-19 Tools (ACT) Accelerator, the global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
While other analyses have highlighted the economic costs of vaccine nationalism, this new study is the first to incorporate both supply and demand shocks, domestic and foreign, at the sector level, for an open economy operating within global supply chains.”

About the public’s health

Supreme Court wipes out lower court rulings in Texas abortion battle: “The Supreme Court handed a victory to advocates of abortion rights Monday, wiping off the books lower court rulings that had upheld a Texas order banning nearly all abortions in the state during the coronavirus pandemic.
Gov. Greg Abbott ordered a halt to nonessential medical procedures in late March to conserve hospital resources and personal protective equipment. Attorney General Ken Paxton then said the order applied to ‘any type of abortions,’ including medication abortions that do not involve surgery.”

About health insurance

Five New Guilty Pleas In Nationwide Telemedicine Pharmacy Health Care Fraud Conspiracy: “[Yesterday,] Larry Everett Smith, 50, of Tampa, Florida, pleaded guilty before Senior District Judge Ronnie Greer to one count of conspiracy to commit health care fraud… Smith faces a term of up to 10 years in prison. 
The First Superseding Indictment, returned December 1, 2020, charged Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers out of $174,202,105 by submitting $931,356,936 in bills to the pharmacy benefit managers for fraudulent prescriptions purchased from a telemarketing company. The indictment alleges the conspiracy began in mid-2015 and lasted through the first months of 2018.” 

Blues plans' high-performance network [HPN] saving 11% on care compared to PPO: ”BCBSA said 45 companies have signed on to offer the Blue HPN plan to employees, reaching 55 markets and 340,000 potential members.
The plan is the only HPN available in the 10 largest U.S. cities, BCBSA said.”

Biden admin has more than $1B in unspent funds to help bolster ACA exchanges: “The Trump administration may have accumulated more than $1 billion in unspent user fee funds that can be used to bolster the Affordable Care Act (ACA) if President Joe Biden starts a special enrollment period, a new analysis finds.
The analysis, released Monday by the Kaiser Family Foundation, outlined ways the Biden administration could improve sign-ups for the ACA’s insurance exchanges, especially as job losses from the COVID-19 pandemic have spurred interest in the exchanges.
Biden is reportedly going to sign an executive order Thursday that will initiate a new open enrollment for the ACA…”

About hospitals and health systems

Most Hospitals Expanding ASC [Ambulatory Surgery Center] Investments: “In two years, the number of hospitals owning or affiliating with more than one ASC jumped 17 percentage points. In 2020, 75% of hospitals with 200-plus beds have more than one ASC. Payer pressures and other market forces have softened hospitals’ historically defensive posture toward ASCs, paving the way for overall growth, lower operating costs and heightened patient satisfaction.”

The Cost of Quarantine: Projecting the Financial Impact of Canceled Elective Surgery on the Nation's Hospitals: The latest study of COVID-19 related hospital losses:
“National revenue loss due to major elective surgery cessation was estimated to be $22.3 billion (B). Recovery to market equilibrium was conserved across strata and influenced by pre- and post-COVID capacity utilization. Median recovery time was 12-22 months across all strata. Lower pre-COVID utilization was associated with fewer months to recovery.”

Through a $500 Million Partnership with the State of Ohio, JobsOhio and Ohio Development Services Agency, Cleveland Clinic Forms Global Center for Pathogen Research & Human Health: “Headquartered in Cleveland and spanning Cleveland Clinic’s international footprint in Florida, London and Abu Dhabi, the Global Center for Pathogen Research & Human Health will bring together a research team focused on broadening understanding of viral pathogens, virus-induced cancers, genomics, immunology and immunotherapies. It will expand upon Cleveland Clinic’s existing programs and expertise, with newly recruited world leaders in immunology, cancer biology, immune-oncology and pathogen research as well as technology development and education. Researchers will expand critical work on studying, preparing and protecting against public health threats such as HIV/AIDS, Dengue fever, Zika and COVID-19.”

Today's News and Commentary

About hospitals and health systems

'Tumultuous' year for hospitals results in 55% drop in median operating margin, Kaufman Hall finds: “Hospitals across the U.S. saw their median 2020 operating margin drop 55.6 percent throughout 2020, without taking into account federal relief aid, according to a new report from healthcare consulting firm Kaufman Hall. When factoring in Coronavirus, Aid, Relief and Economic Security Act cash, hospitals saw their median operating margins dip 16.6 percent…
Overall, hosptials saw their median operating margin at 0.3 percent in 2020, without funding from the CARES Act. With funding, the median operating margin was 2.7 percent.”

About COVID-19

Transcript: Dr. Deborah Birx on "Face the Nation," January 24, 2021: The entire interview is interesting but this remark was especially revealing: “I saw the president presenting graphs that I never made. So, I know that someone- or someone out there or someone inside was creating a parallel set of data and graphics that were shown to the president. I know what I sent up and I know that what was in his hands was different from that. You can't do that. You have to use the entire database--”

Low Patient Portal Adoption Could Stymie COVID-19 Vaccine Rollout:”Up to 45 percent of patients ages 50 and older don’t have a patient portal, the very tool most providers across the country are using to communicate with patients about the COVID-19 vaccine, according to new data out of the University of Michigan’s Institute for Healthcare Policy and Innovation.
This could seriously hamper provider efforts to notify patients as they become eligible for the COVID-19 vaccine and, at some organizations, take the next steps to schedule a vaccination.”

U.S. CDC says 21.8 million doses of COVID-19 vaccines administered: “U.S. Centers for Disease Control and Prevention said it had administered 21,848,655 doses of COVID-19 vaccines in the country as of Sunday morning.
The tally of vaccine doses is for both Moderna Inc’s vaccine and one by Pfizer Inc and BioNTech as of 6 a.m. EST (1100 GMT) on Sunday, the agency said.
It said 18,502,131 people had received one or more doses, while 3,216,836 people got the second dose as of Sunday.”

FDA rolls back N95 mask reuse to 4 decontamination cycles: “The FDA has rolled back its emergency authorizations for N95 respirator decontamination systems, cutting down the number of times the agency said each mask could be safely reused.
During the early stages of the pandemic, when supplies of personal protective equipment and N95 filters were at a minimum, the FDA allowed masks to be reprocessed up to 20 times with certain hardware.“

Fauci: Vaccinations will help coronavirus variants from emerging: Another good reason to vaccinate the population quickly.
”Covid-19 vaccinations will not only help stop the virus from spreading, they will also hamper the coronavirus' ability to mutate into new variants, Dr. Anthony Fauci said on Thursday. 
’Viruses don't mutate unless they replicate,’ Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a news briefing at the White House, his first under the administration of President Joe Biden.
’And if you can suppress that by a very good vaccine campaign, then you could actually avoid this deleterious effect that you might get from the mutations,"‘Fauci said.”

Merck cans both its COVID-19 vaccines due to weak clinical data: “Merck has stopped development of its two COVID-19 vaccine candidates after getting a look at phase 1 data. The vaccine powerhouse said neither candidate triggered immune responses comparable to those achieved by rival jabs, leading Merck to cut its losses and focus on COVID-19 therapeutics.”

2 in 5 Americans live where COVID-19 strains hospital ICUs: “Straining to handle record numbers of COVID-19 patients, hundreds of the nation’s intensive care units are running out of space and supplies and competing to hire temporary traveling nurses at soaring rates. Many of the facilities are clustered in the South and West.
An Associated Press analysis of federal hospital data shows that since November, the share of U.S. hospitals nearing the breaking point has doubled. More than 40% of Americans now live in areas running out of ICU space, with only 15% of beds still available.”

Israel sees 60% drop in hospitalizations for age 60-plus 3 weeks after 1st shot: “Full effects of Pfizer’s shots only kick in around a month after inoculation, but data from Israel shows there is a stark drop in infections even before that point.”

Moderna vaccine protects against British and South African variants, company says: “The coronavirus vaccine developed by Moderna triggers an immune response that protected in laboratory tests against two variants of the virus first detected in Britain and South Africa, the company said Monday.
The finding was largely encouraging but contained a clear warning sign: Even though the vaccine generated disease-fighting antibodies that worked against the South African variant, that efficacy was diminished. Moderna said there was a reduction in response, prompting the company to design a new potential vaccine that could be added to the current two-dose regimen.”

Pfizer ships fewer Covid vaccine vials to U.S. after Trump FDA label change: “Pfizer is counting extra coronavirus vaccine it uses to top off each of its vials toward its commitment to deliver 200 million shots for the U.S. pandemic response — even though there aren't enough syringes capable of squeezing out the extra fluid.”

Civica Rx lays out $124M sterile injectables plant, pegged to supply COVID-19 drugs and more: “Construction has already started on the 120,000-square-foot plant, pegged to come online within the next three years, Civica said. The facility will ultimately crank out 90 million vials and 50 million prefilled syringes per year, focusing on drugs for COVID-19 patients as well as meds used in emergency rooms, intensive care units and surgeries.”

Researchers are developing color-changing stickers for masks to detect COVID-19: “The sticker is a test strip and blister pack that can be placed on N95, surgical or cloth masks and detect SARS-CoV-2 in the user's breath or saliva…
As the person wearing the mask breathes, the test strip aims to detect protein-cleaving molecules produced from a COVID-19 infection. Once the user removes the mask and test materials, they squeeze out the contents of the blister pack onto the test strip. If the test strip turns a specific color, it means infection molecules are present.”

Davos Agenda: What you need to know about the future of global health: These health goals are COVID-19 driven. Read the article for the World Economic Forum Agenda.

Today's News and Commentary

About COVID-19

High‐Resolution Agent‐Based Modeling of COVID‐19 Spreading in a Small Town: This simulation looks at effectiveness of targeted interventions versus generalized measures in controlling COVID-19. The model was based on New Rochelle, NY. The authors concluded:
“To illustrate the model's value in analyzing prospective ‘what‐if’ questions, we performed an immunization study in which we evaluated several vaccination strategies of future importance. In particular, we compared the impact of vaccination of select group of vulnerable individuals, including school employees, retirement home employees and residents, and the totality of the two thousand hospital employees in the town, a randomly selected group of 2000 individuals, and 20 000 randomly selected individuals out of the 80 000 people living in New Rochelle. Our results suggest that prioritizing vaccination of high‐risk individuals has a marginal effect on the count of COVID‐19 deaths. Predictably, a much more significant improvement is registered when a quarter of the town is vaccinated. Importantly, the benefits of the restrictive measures in place during the first wave greatly surpass those from any of these selective vaccination scenarios.[Emphasis added]

Lilly's bamlanivimab cuts risk of COVID-19 by up to 80% at nursing homes: “Eli Lilly announced Thursday that in a Phase III study, bamlanivimab was shown to significantly reduce the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The findings from the BLAZE-2 COVID-19 prevention trial suggest the risk was decreased by up to 80% in people administered the antibody therapy versus those in the same facility given placebo.”

Single Covid vaccine dose in Israel 'less effective than we thought': “Israel's coronavirus tsar Nachman Ash warned that a single dose of the Pfizer/BioNTech coronavirus vaccine may be providing less protection than originally hoped…
By contrast, those who had received their second dose of the Pfizer vaccine had a six- to 12-fold increase in antibodies, according to data released earlier this week by Sheba Medical Center in Tel Hashomer.
Pfizer itself says a single dose of its vaccine is about 52% effective, although some countries, including the UK, have delayed administering second doses in a bid to maximise the number of people given a first dose.”

Some states want to buy their own COVID vaccines. The Biden administration says no.: “The Biden administration is rejecting calls from some states to buy COVID-19 vaccine doses directly from Pfizer, as governors hunt for ways to supplement their limited supply of shots.
The divide on that question counts among the early pandemic challenges facing the 46th president, as his team tackles a nationwide vaccine effort that has progressed unevenly in the face of overwhelming demand.
‘We need to have a national approach to vaccinations, and must ensure states aren't competing against each other like they did with PPE, ventilators, and tests,’ spokesperson T.J. Ducklo said in a statement.”

Timing of second Covid vaccine doesn't need to be exact. Just get it, experts say.: “‘The second dose should be administered as close to the recommended interval as possible,’ the CDC said in an update to its website Thursday. ‘However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna Covid-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose.’”

New CDC director says Covid vaccine won't be in every pharmacy by late February: “The new director of the Centers for Disease Control and Prevention said Thursday that the Covid-19 vaccine would not be widely available by late February as the Trump administration previously said.”

Executive Order on Protecting Worker Health and Safety: No specific actions are in this order; it directs government agencies to study and come up with policies to protect workers from COVID-19. Particularly, it invokes OSHA protections.

About health insurance

ACO participation reaches new low as advocates press Biden for major changes: “The number of ACOs for 2021 is below the ACOs that started with the Trump administration in 2017 (480), according to new data from the Centers for Medicare & Medicaid Services, which oversees the program. ACO participation reached a record high of 561 in 2018 but has declined down to 518 in 2019 and 517 last year, federal data shows.
While participation in the program has shifted and declined over the years, ACOs still continue to generate savings for Medicare. The program generated $2.4 billion in gross savings for Medicare in 2019 compared with 1.7 billion in 2018…”

CMS Clarifies 2021 PFS [Physician Fee Schedule] Reimbursements for Remote Patient Monitoring: “In the final rule, to qualify for reimbursement under CPT codes 99457 and 99458, CMS mandated at least 20 minutes of interactive communication time between provider and patient over a calendar month, but that interactive communication couldn’t be part of the 20 minutes of RPM care. The agency has now clarified that “interactive communication” can include both in-person and connected health channels.”

MA Plans See 99% Member Satisfaction Among Non-White Members: “The results indicated that 98 percent of seniors on Medicare Advantage were satisfied with their health plan. Non-white Medicare Advantage beneficiaries expressed even higher satisfaction, with 99 percent reporting that they were satisfied with their coverage.
Similar percentages of members were satisfied with how their health plan managed the pandemic (98 percent) and the network of providers and healthcare systems available to them (97 percent).
The survey also asked which common supplemental health benefits the participants utilized. Vision care was most commonly used with 64 percent of Medicare Advantage members having used this supplemental benefit.”
Caveat: Medicare beneficiaries who choose MA plans are a self-selected group who seek such cost and benefit advantages compared to traditional Medicare with its enhanced freedom of choice.

UnitedHealthcare, Humana & more: 7 payers expanding telehealth strategies: The article is a good brief summary of where these companies stand on telehealth benefits, and hence, where the industry is going. One major trend coming out of the COVID-19 experience is making telehealth a permanent benefit.

9th Circ. Delays Public Charge Ruling As Justices Mull Case: “The Ninth Circuit permitted the U. S. Department of Homeland Security to implement the so-called public charge rule on Wednesday, saying it will delay the effective date of its ruling barring the policy while the U. S. Supreme Court considers the rule's legality. In a one-page order, the appeals court granted DHS' request that it stay its mandate halting enforcement of the Trump administration's public charge rule, which makes it more difficult for immigrants on or deemed likely to use certain public benefits to obtain green cards.”

Orange County insurance brokers help pay off more than $2.1M in medical debt for those in need: “More than 80 employees across the company have donated their own money to help erase more than $2.1 million worth of medical debt. It's for people who live at or below 200% of the poverty line in Orange County…
Through a partnership with the non-profit RIP Medical Debt, every $100 donated forgives $10,000 in medical debt.”
One of many such examples of RIP Medical Debt helping pay off medical bills.

About pharma

FDA approves 1st long-acting HIV drug combo, monthly shots: “U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.
Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals..
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.”

HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts: “The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021…
Pursuant to the regulatory rule freeze, the Department of Health and Human Services (HHS) has frozen a final rule that would have blocked community health centers (i.e., federally qualified health centers) from receiving future grant funding unless the health centers provided a complete pass-through of 340B discounts on insulin and epi-pens to low-income patients (the 340B Insulin Pass-Through Rule).  Community health centers staunchly opposed the 340B Insulin Pass-Through Rule, arguing that it would have added significant bureaucratic obligations to centers’ operations while making a relatively minimal impact on the costs of drugs provided to center patients. The 340B Insulin Pass-Through Rule was slated to go into effect today, Jan. 22, 2021.
As a result of HHS’ freeze, the effective date of the 340B Insulin Pass-Through Rule has now been delayed until at least March 22, 2021. While there is currently no indication whether the Biden administration will ultimately rescind or revise the 340B Insulin Pass-Through Rule, the delay offers community health centers additional time to develop plans to comply with the 340B Insulin Pass-Through Rule.”

Insys Founder To Pay NJ $5M In Opioid Bribery Settlement: “Convicted Insys Therapeutics founder John N. Kapoor has agreed to pay New Jersey $5 million to resolve allegations that he orchestrated bribes to doctors in the state as part of a nationwide kickback scheme to boost sales of Insys' powerful opioid Subsys, the state's attorney general said Thursday. New Jersey Attorney General Gurbir S. Grewal said Thursday that the deal with Insys' 77-year-old founder Kapoor marks the first settlement the state has made in any civil lawsuit against people and corporations accused of fraudulently peddling opioids and that it does not resolve the claims against bankrupt Insys.”

 About healthcare systems

Implementation of Newly Enacted Hospital Price Transparency: “ADVI Analytics explored the top 20 largest hospitals in the county (as determined by number of beds from Becker’s Hospital Review). We found the results varied greatly amongst the hospitals as some made the required information obvious on their websites while other seemingly buried the links. All of the top 20 hospitals published some type of pricing information but not all appeared to completely comply with the mandate and show information for 300 shoppable procedures. Other issues that we identified with the data included: data was not able to download in a useable format, hospitals did not provide HCPCS codes for services, and variability in hospitals’ terms for the pricing information. Among the data we analyzed, we found the price of code 99203 (Level 3 Evaluation and Management code), one of the most commonly billed services in Medicare, ranged from $200 to $1534. Another high-volume radiology code, 70450 (CT, head or brain, without contrast) ranged from $90 to $2,033.”

Hospitals mark up drug prices by 250% on average, analysis finds: “Hospitals mark up drug prices by 250 percent on average, according to an analysis from Ronny Gal, a senior research analyst at Bernstein. 
Mr. Gal analyzed prices hospitals charge for drugs, with data disclosed as of Jan. 1. He found that hospitals mark up some drugs, such as Epogen, an anemia treatment, by as much as 533 percent compared to the average sales price. This incentivizes hospitals to use expensive branded products instead of biosimilars, he said…
Hospitals also charge a range of prices for the same drug, Mr. Gal said. The average variation is about 36 percent.”
Price gouging and cost shifting…

Today's News and Commentary

President-elect Biden Announces American Rescue Plan (Emergency Legislative Package to Fund Vaccinations, Provide Immediate, Direct Relief to Families Bearing the Brunt of the COVID-19 Crisis, and Support Struggling Communities) This statement is a clear and well-written short text of the Rescue Plan. It is not that long and is worth reading. The full (198 page) version is here. For updates, check this link.

About health insurance

Biden Administration Plans to Expand COBRA, ACA Premium Subsidies: The Rescue Plan will extend and increase premium subsidies for COBRA and Affordable Care Act enrollees, with an estimated cost of approximately $57.0 billion over the next three years.

Independent Evaluation of Comprehensive Primary Care Plus (CPC+): This third annual report from Mathematica found that: “There were a few small favorable impacts of CPC+ on some measures of service use, quality of care, and patient experience for Medicare fee- for-service (FFS) beneficiaries during the first three years, but with CMS’s enhanced payments, CPC+ increased total Medicare expenditures. It is still too early to draw conclusions about the likely longer- term effects of CPC+.”

Proposed Decision Memo for Screening for Colorectal Cancer - Blood-Based Biomarker Tests (CAG-00454N): This page has the latest coverage criteria for Medicare patients to have a blood biomarker screen for colon cancer.

Optum expects to add 10,000 physicians this year: “Currently, OptumCare employs or is affiliated with 50,000 physicians and 1,400 clinics. OptumCare expects that its employed and affiliated physicians will grow by at least 10,000 during 2021, according to UnitedHealth CEO David Wichmann.”

Medicare Advantage Star Ratings: 30 measures to know for 2022: “CMS ranks Medicare Advantage on a quality scale of one to five stars, with five representing excellent performance and one reflecting poor performance. To assign stars, Medicare analyzes how health plans perform on certain measures. At the contract level, CMS only includes the measure if numeric value scores are available for both the current year and prior years.
The 30 measures that will be used to calculate the 2022 Star Ratings for Medicare Advantage plans are”listed in the article.
In addition to quality indicators, the stars also determine payments to these plans.

Two Women Plead Guilty In $109M Medicare Fraud Scheme: “Two women pled guilty Wednesday for their roles in a multimillion-dollar Medicare fraud scheme that profited by selling patient data and using that information to submit $109 million worth of false claims, according to the U. S. Department of Justice. Jessica Jones, 30, of Colorado, and Elizabeth Putulin, 30, of Florida, both entered guilty pleas to one count of conspiracy to commit health care fraud. The two women were accused of conspiring with Juan Camilo Perez Buitrago to submit more than $109 million in false claims for durable medical equipment such as back or knee braces by creating shell companies…”

Healthcare execs, physicians pardoned by Trump: In addition to yesterday’s post, here are additional execs who were pardoned (all for insurance fraud crimes).

About COVID-19

New data back ability of Pfizer, BioNTech's COVID-19 vaccine to foil UK strain: “Pfizer and BioNTech on Wednesday reported results from another in-vitro study indicating that their COVID-19 vaccine BNT162b2 is likely capable of neutralising the rapidly spreading UK strain of SARS-CoV-2, also known as B.1.1.7. The findings, which were published on the preprint server bioRxiv, follow the release of a similar laboratory study earlier this month showing that antibodies from vaccinated people were able to efficiently neutralise variants of SARS-CoV-2 with a key mutation, dubbed N501Y, found in the UK variant, as well as another highly transmissible strain that has emerged in South Africa.” However, Emerging Coronavirus Variants May Pose Challenges to Vaccines: “People who had survived mild infections with the coronavirus may still be vulnerable to infection with a new variant; and more worryingly, the vaccines may be less effective against the variants.”

The 10 Biden officials to watch on the Covid-19 response: Read the article for details.

Amazon offers Biden help with Covid-19 vaccine distribution: “Amazon has extended an offer to President Joe Biden to assist with the national distribution of Covid-19 vaccines, a move that could expedite the federal effort to combat the pandemic.”

Biden's just-released coronavirus strategy keeps vaccine goals modest: The article is an update on this fast-moving program. Today, President Biden will “sign 10 more executive orders and directives aimed at mitigating various pandemic-caused crises. They include:

  • Creating a Pandemic Testing Board that can spur a “surge” in the capacity for coronavirus tests.

  • Fostering research into new treatments for covid-19.

  • Strengthening the collection and analysis of data to shape the government’s response to the crisis.

  • Directing the federal occupational safety agency to release and enforce guidelines to protect workers from getting infected.

  • Directing the Departments of Education and Health and Human Services to provide guidance on safe reopening and operating for schools, child care providers, and institutions of higher education.

  • Requiring mask-wearing in airports and other modes of public transportation including trains, airplanes, maritime vessels and intercity buses.”

Europe’s growing mask ask: Ditch the cloth ones for medical-grade coverings: “Germany on Tuesday night made it mandatory for people riding on public transport or in supermarkets to wear medical style masks: either N95s, the Chinese or European equivalent KN95 or FFP2s, or a surgical mask.
It follows a stricter regulation from the German state of Bavaria this week that required N95 equivalents in stores and on public transport. Austria will introduce the same measures from Monday…
Meanwhile in France, the country’s health advisory council on Monday discouraged the wearing of inefficient cloth and homemade masks, also arguing they may not offer sufficient protection against the more highly transmissible coronavirusvariants.”

47% of Americans say vaccinations are moving too slowly: “A plurality of Republicans and Independents, and a majority of Democrats, say the rollout is moving too slowly.
Among those who feel it’s going too slowly, however, there’s a sharp partisan divide over who’s at fault: 60% of Democrats say President Trump is to blame, while a plurality of Republicans (36%) say state governments are the problem…”
But perhaps the most significant finding in this Axios-Harris poll is: “(69%) of Americans say they are likely to take the COVID-19 vaccine, the highest percentage other than the first time we asked in April 2020 (when 73% said they would take the vaccine).”

About healthcare IT

Tripathi tapped as Biden's national coordinator for health IT: “An expert on interoperability, privacy, and technology standards, Tripathi most recently served as chief strategy officer at Arcadia, a population health management solutions company. Before joining Arcadia, [he] had been president and CEO of the Massachusetts eHealth Collaborative (MAeHC), a nonprofit health IT advisory and clinical data analytics company. MAeHC was formed in 2005 and played a significant leadership role in advising and leading various interoperability and standards activities, including HL7 and FHIR.”

ONC investing $20M to boost COVID-19 vaccine data sharing efforts: “ONC will award nearly $20 million in funds from the Coronavirus Aid, Relief, and Economic Security (CARES) Act signed by former President Donald Trump in March to support the nation’s vaccination efforts to fight the COVID-19 pandemic.
The new investments will support opportunities to track vaccination progress, help clinicians pinpoint and contact high-risk patients, and coordinate appointments for patients due to receive the second dose of the vaccine, according to a press release.”

About diagnostics

Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech: “Thermo Fisher Scientific Inc… today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction. 
Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A.”

In vitro test maker Ortho Clinical Diagnostics files $1.5B Nasdaq IPO: “Ortho Clinical Diagnostics is hoping to pay down a large portion of its debts by riding a wave of COVID-19 and broader in vitro lab testing demands to a $1.5 billion IPO. 
The company is offering 70 million shares on the Nasdaq—slated for the ticker OCDX—that are expected to be priced between $20 and $23 apiece in the coming week. Hitting the midpoint of that range would bestow a market value of $4.9 billion…”

Boston Scientific buys wearable heart monitor maker Preventice for $1.2B, as in-hospital sales take hit from pandemic: “Boston Scientific has moved to acquire the remote cardiac monitoring developer Preventice Solutions, a company it has partnered with and invested in since 2015.
On paper, the transaction features a cash payment of $925 million, plus an additional $300 million tied to the achievement of certain commercial milestones. However, Boston Scientific has built up a 22% stake in Preventice, which is expected to lower the net payments to $720 million upfront and about $230 million in milestone money, respectively.”

About pharma

McLaren Health Care Settles with DEA: “The Agreement is the culmination of a multi-year effort with the DEA, which identified prescribing irregularities at the McLaren Port Huron retail pharmacy in 2018, prompting McLaren to terminate a pharmacist who was diverting opioids for his own personal use. A subsequent review included an exhaustive assessment of pharmacy protocols at other McLaren facilities — in some cases stretching over periods of up to 12 years. At the conclusion of its review, the DEA identified irregularities associated with recordkeeping, dispensing and distribution of controlled substances, particularly among retail pharmacies operating under "legacy" pharmacy protocols that had been in place prior to McLaren's acquisition of their operations.”
The penalty is $7.5M, making it the largest settlement ever for alleged drug diversion.

Today's News and Commentary

Expected immediate actions after today’s inauguration:

President Biden will

  • Stop the US withdrawal from the WHO.
    And in a related action: Biden will join WHO-backed vaccine initiative

  • Require masks on federal property.

  • Restore the global health security and biodefense team.

  • Rejoin the Paris climate accord.

About health insurance

CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data To Identify and Focus on Error-Prone Providers: From the HHS OIG: “CMS and its contractors did not use CERT [Comprehensive Error Rate Testing] to identify and focus on error-prone providers for review and corrective action. Using CERT data, we identified 100 error-prone providers from 2014 through 2017. Of the $5.8 million reviewed by CERT, $3.5 million was incorrect, which is an improper payment rate of 60.7 percent. We determined that during the same period, Medicare made $19.1 billion in FFS payments to these 100 error-prone providers…
We recommend that CMS: (1) review the list of 100 error-prone providers identified in this audit and take specific action as appropriate, such as prior authorization, prepayment reviews, and postpayment reviews, and (2) use annual CERT data to identify individual providers that have an increased risk of receiving improper payments and apply additional program integrity tools to these providers.”

Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme: ”A Mississippi businessman was sentenced… for his role in a multimillion-dollar scheme to defraud TRICARE, the health care benefit program serving U.S. military, veterans, and their respective family members, as well as private health care benefit programs.
Wade Ashley Walters, 54, of Hattiesburg, a co-owner of numerous compounding pharmacies and pharmaceutical distributors, was sentenced… on his guilty plea to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering. U.S. District Judge Keith Starrett of the Southern District of Mississippi ordered Walters to serve a total of 18 years in prison and to pay $287,659,569 in restitution. Walters was remanded into custody following the sentencing hearing. Walters was further ordered to forfeit $56,565,963, representing the proceeds he personally derived from the fraud scheme…
Between 2012 and 2016, Walters orchestrated a scheme to defraud TRICARE and other health care benefit programs by distributing compounded medications that were not medically necessary.”

Trump grants clemency to 143 people in late-night pardon blast: Among the actions was commutation of “the sentence of Salomon Melgen, a West Palm Beach, Fla., eye doctor who was sentenced in 2018 to 17 years in prison, accused of stealing $73 million from Medicare by persuading elderly patients to undergo unnecessary procedures.
Separately, Melgen had been accused of bribing Sen. Robert Menendez (D-N.J.) to intercede on his behalf in the Medicare investigation.”

AMA announces update to COVID-19 vaccine CPT codes: The new codes will be used to bill and track administration of J&J’s vaccine when it is available.

UnitedHealth Group Reports Fourth Quarter and Full Year 2020 Financial Results: ”The full year and fourth quarter results reflect continued strong performance, impacted by COVID-19 care costs, continued voluntary consumer and customer assistance initiatives and other pandemic-related factors. As expected, fourth quarter net earnings of $2.30 per share and adjusted earnings of $2.52 per share declined as care patterns normalized, while COVID-19 costs rose, and further rebate effects were recognized.  The 2020 results were consistent with the outlook provided by the Company at its December 1st, 2020 Investor Conference. 
The Company affirmed its recently issued full year earnings outlook for 2021, including net earnings of $16.90 to $17.40 per share and adjusted net earnings of $17.75 to $18.25 per share. As previously discussed, this outlook includes approximately $1.80 per share in potential net unfavorable impact to accommodate continuing COVID-19 effects, such as: testing and treatment costs; the residual impact of people deferring care in 2020; and unemployment and other economy-driven factors.”

Feds Near Win In Mass. ACA Birth Control Coverage Suit: “A Massachusetts federal judge has ruled that the state can't block a pair of Trump administration rules expanding the religious exemption to the Affordable Care Act's contraceptive mandate, finding that the exemptions don't run afoul of the U. S. Constitution or federal statutes in light of the high court's recent Little Sisters ruling. In a 29-page, Jan. 15 opinion, U. S. District Judge Nathaniel M. Gorton said the state has not established that the final rules are statutorily or constitutionally invalid, and therefore he was denying its bid for summary judgment…”

About COVID-19

Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots: Seniors want to know if they were in the placebo group for Novavax’s vaccine. If so, they want to drop out and get a vaccine that is already approved.

Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites — Pima County, Arizona, November 3–17, 2020: Published yesterday from the CDC. “Sensitivity of the BinaxNOW [from Abbott] antigen test, compared with polymerase chain reaction testing, was lower when used to test specimens from asymptomatic (35.8%) than from symptomatic (64.2%) persons, but specificity was high. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus.”

Lab-Developed Virus Tests Get Authorization Without FDA Input: “The HHS on Tuesday authorized three lab-developed Covid-19 tests in an unusual move that skirts the FDA’s traditional role to review products.
The tests from the Ponce Medical School in Puerto Rico, the University of Louisville Infectious Diseases Laboratory in Kentucky, and the Hospital of the University of Pennsylvania are already on the market, Health and Human Services testing leader Brett Giroir said in an interview Tuesday. The authorizations give them liability protections and insurance coverage through federal laws passed earlier in the pandemic.”

Cheap antiparasitic could cut chance of Covid-19 deaths by up to 75%: “The University of Liverpool’s Andrew Hill and others carried out a meta-analytical breakdown of 18 studies that found that ivermectin was associated with reduced inflammation and a faster elimination of Sars-Cov-2, the virus that causes Covid-19. In six of these trials, the risk of death was reduced by 75 per cent in a subset of patients with moderate to severe Covid-19.”
More data needs to be accumulated. Recall we have had many drugs touted as helping prevent/treat COVID-19. Remember hydroxychloroquine?

US scientists develop blood test for high-risk Covid-19 patients: “Scientists at Washington University School of Medicine in St Louis, US, have developed a new simple and rapid test that can measure mitochondrial DNA in the blood of a Covid-19 patient and identify those who are at highest risk of severe disease or death.”

Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine: “Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot” starting in July.
“The study will enroll adults who previously took part in the initial phase 1 study led by the National Institutes of Health [and] aims to assess the safety of an extra shot given a year after the second dose and the additional immune response it elicits.”

Association of Intensive Care Unit Patient Load and Demand With Mortality Rates in US Department of Veterans Affairs Hospitals During the COVID-19 Pandemic: Volume/quality relationships do not always apply.
”In this cohort study of patients with COVID-19 in US VA hospitals, receiving treatment during peak COVID-19 ICU demand, with demand describing the caseload of patients with COVID-19 in the ICU when the patient was treated compared with peak COVID-19 ICU caseload, was consistently and independently associated with COVID-19 ICU mortality. In the extreme case, the adjusted hazard of death was 1.94 for patients with COVID-19 treated in the ICU during periods with greater than 75% to 100% of the peak COVID-19 ICU caseload. The finding that COVID-19 ICU demand was associated with increased mortality for patients with critical COVID-19 early in the pandemic (ie, March-May) and later in the pandemic (ie, June-August) supports the overall study results that suggested that strains on critical care capacity were associated with increased COVID-19 ICU mortality.”
A number of “Limitations” at the end of the article should make the reader interpret these results cautiously.

About pharma

Merck & Co. loses Supreme Court bid to restore $2.5-billion award in Gilead patent dispute: “The US Supreme Court on Tuesday declined to hear arguments by Merck & Co. in its attempt to appeal a lower court ruling that had overturned a $2.5-billion award it won against Gilead Sciences in 2016. The patent infringement case involved the latter's hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir).”

Mylan Can't Escape EpiPen Distributors' Antitrust Claims: “A Minnesota federal judge has refused to throw out a proposed class action that accuses drugmaker Mylan Inc. of paying bribes and kickbacks to a group of pharmacy benefit managers and conspiring to engage in anti-competitive practices that jacked up the price of its anti-allergy injection EpiPen. Mylan and the so-called PBM defendants — Express Scripts, Optum and CVS Caremark — each argued in separate but identical motions to dismiss that they did nothing unlawful outside their normal commercial business practices.”

About healthcare IT

OCR lifts HIPAA penalties for COVID-19 vaccine scheduling apps: 5 details: “HHS' Office for Civil Rights will not impose penalties for potential HIPAA violations of healthcare providers and their business associates who use online or web-based scheduling applications to coordinate COVID-19 vaccine appointments.”

Philips to buy medical device integrator Capsule Technologies for $635M: “Philips has moved to acquire Capsule Technologies—a provider of data platforms that aim to connect all of the medical devices and record systems within a hospital—to help build out its integrated care and vital sign monitoring solutions.
The $635 million cash deal is expected to be completed by the end of March, with Capsule’s 300 employees slated to join Philips’ connected care division. Capsule’s software-as-a-service offerings are currently used by over 2,800 healthcare organizations globally, with development teams based in the U.S. and France, while its platform can connect to over 940 unique devices.”

About healthcare quality

Predicted Cost Savings Achieved by the Radiology Support, Communication and Alignment Network from Reducing Medical Imaging Overutilization in the Medicare Population: “The Radiology Support, Communication and Alignment Network (R-SCAN) is a quality improvement program through which patients, referring clinicians, and radiologists collaborate to improve imaging appropriateness based on Choosing Wisely recommendations and ACR Appropriateness Criteria. R-SCAN was shown previously to increase the odds of obtaining an appropriate, higher patient or diagnostic value, imaging study. In the current study, we aimed to estimate the potential imaging cost savings associated with R-SCAN use for the Medicare population…
We observed a substantial reduction in the costs associated with lesser value imaging in the R-SCAN cohort, totaling $260,000 over 3.5 months. When extrapolated to the Medicare population, the potential cost reductions associated with the decrease in lesser value imaging totaled $433 million yearly.”

About healthcare systems

Community Health Taps Into Junk-Bond Frenzy to Tame Debt: Community Health Systems Inc., the debt-laden hospital chain that’s been staging a comeback, has more than doubled the size of a bond offering as it takes advantage of some of the lowest yields ever for speculative-grade issuers.
After strong recent earnings results, the company is using the momentum to refinance a high coupon and push out maturities.
Community is selling a $1.8 billion high-yield bond maturing in 2029 and announced a related tender offer Tuesday…
Community Health was once known as one of the most distressed companies in the healthcare sector. But the firm has been selling hospitals to raise cash and refinancing debt to improve its balance sheet. In recent months, the bonds have risen after it posted better-than-expected earnings in the second and third quarters.
The company is rated in the riskiest tier of junk debt, CCC+ by S&P Global Ratings and CCC by Fitch Ratings. Moody’s Investors Service upgraded the company by one notch to Caa2 on Tuesday and viewed the new transaction as a credit positive event.”