Today's News and Commentary

About health insurance

Trump administration calls for Supreme Court to strike down ObamaCare: “The Trump administration on Thursday night argued in a legal brief filed to the Supreme Court that the entire Affordable Care Act (ACA) should be invalidated. 
The legal filing, while expected, makes official the Trump administration's position in the Supreme Court against the health care law months ahead of the election, at a time when Democrats are hammering President trump over his position on health care.  
Overturning the ACA would take away health insurance coverage for about 20 million people, and the stakes are even higher given the effects of the current pandemic.”

Humana, University of Houston started a pop-health-focused med school 2 years ago. Then COVID-19 hit: While not strictly about insurance, this venture is an interesting example of cross-sector cooperation. “Since December 2018, the Humana Integrated Health Systems Science Institute at UH has kick-started more than 15 programs and provided 10,000 hours of interdisciplinary medical education to 6,000 people including UH students, faculty, staff and Humana associates.”

About the public’s health

U.S. sets another single-day record for new coronavirus cases, surpassing 40,000 for first time: The headline speaks for itself.

The Trump administration is eyeing a new testing strategy for coronavirus, Anthony Fauci says: He advocated for “pool testing.” “The approach works this way: Samples from, say, 20 people are combined into a single pool. One coronavirus test is used on the entire pool. If the test comes back negative, researchers know they can move on to another pool of samples. If it comes back positive, only then would each individual be tested.”

Flu Vaccine Only 39% Effective This Past Season, CDC Panel Says: “The influenza vaccine was 39% effective against medically attended influenza for the 2019-2020 flu season; it offered lower protection against A/H1N1pmd09 virus 31%) compared with previous seasons but was 44% effective against B/Victoria virus, according to information presented June 24 at a meeting of the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC).
The committee voted unanimously (14 yes, 0 no) to accept changes to the influenza vaccine for the 2020-2021 season.”

LabCorp Launches COVID-19 Antibody Test: What is different about this test is that it “assesses the ability of antibodies to inhibit the SARS-CoV-2 virus.” That ability could make it particularly valuable to assess vaccine effectiveness.

New guidelines support probiotics for C. difficile prevention, but few other uses:”The American Gastroenterological Association recently issued clinical practice guidelines on the role of probiotics in the management of gastrointestinal disorders.” The “guidelines found little evidence to support probiotics in a number of the conditions assessed and recommended their use for treatment only in the context of a clinical trial for patients with Clostridioides difficile infection, Crohn's disease, ulcerative colitis, or irritable bowel syndrome.
The guidelines suggested specific probiotics (over others or none) for prevention of C. difficile in patients on antibiotic treatment…”

Push to Expand Doctors’ Legal Immunity for Virus Draws Ire (1): “As physicians start to greenlight the joint replacements, heart procedures, and non-emergency surgeries that were postponed months earlier, the nation’s largest association of medical providers is pushing to make sure doctors aren’t held liable for any ill effects from the delayed care.” This article is a really good discussion of this issue.

About pharma

Gilead’s Virus Drug Donation Runs Out While Outbreak Deepens:”The federal government’s supply of Covid-19 treatment remdesivir will run out by June 29, leaving hospitals worried about their supplies for the summer and fall.”

No presents anymore': Inside Novartis' scheme to boost Lucentis sales in Greece: “Novartis has faced years of investigations into bribes paid to doctors in Greece, and this week, the company inked a $347 million deal with U.S. authorities to put the issue and others to rest. In a new deferred prosecution agreement, the DOJ lays out details behind the scheme and the company's efforts to conceal its illicit payments.
From 2012 to 2015, Novartis paid doctors to attend medical congresses in Greece and internationally, with per-doctor expenses sometimes exceeding $6,000 per trip…
In reality, the trips were designed to ‘improperly influence’ the Greek doctors to prescribe wet age-related macular degeneration drug Lucentis…”

About health technology

Medtronic's brain-reading stimulator nets FDA approval: Fascinating! “The FDA has approved Medtronic’s latest deep-brain stimulation implant, featuring the ability to read, capture and transmit a patient’s brain signals during therapy.
This would allow for more personalized treatments for patients with Parkinson’s disease, tremors, epilepsy, dystonia or obsessive-compulsive disorder by correlating readings with patient-recorded actions and symptoms, as well as medication intake, and then tailoring their neurostimulation accordingly, the company said. A customized Samsung mobile device also allows patients to manage their own therapy.”

Today's News and Commentary

About the public’s health

Update on yesterday’s story about Japan’s response to disease tracking: My friend and colleague, Professor Naoki Igagami, MD in Tokyo, wrote to me that the health centers have been “ held responsible for their slow response. All wanting to have PCR must be authorized by them. Only those who had severe symptoms or who had contact were tested.” His comments highlight the importance of first hand reporting from unbiased sources.

Two articles on allocation of scarce resources:
A Proposed Lottery System to Allocate Scarce COVID-19 Medications: A proposal to deal with scarcity of medications in a crisis.
A Global Framework to Ensure Equitable and Fair Allocation of COVID-19 Products:This position paper from the WHO outlines “the major elements of WHO’s proposal for a Global Allocation Framework for COVID-19 products” and illustrates “the potential use of this framework to allocate vaccines.”

A mathematical model reveals the influence of population heterogeneity on herd immunity to SARS-CoV-2: “We show that population heterogeneity can significantly impact disease-induced immunity as the proportion infected in groups with the highest contact rates is greater than in groups with low contact rates. We estimate that if R0 = 2.5 [the number infected by each affected person] in an age-structured community with mixing rates fitted to social activity then the disease-induced herd immunity level can be around 43%, which is substantially less than the classical herd immunity level of 60% obtained through homogeneous immunization of the population.”

CDC and drugmakers boost flu vaccine doses amid fears of an unprecedented respiratory illness season: “Even though flu season doesn’t begin until the fall, major flu vaccine manufacturers say they plan to boost production by about 10 percent, to about 189 million doses, up from 170 million doses last year, to ensure enough doses exist for an anticipated surge in people seeking flu shots.”

Brazilian President Bolsonaro ordered to wear face covering or pay fine: The headline and implications for our country speak for themselves.

Morehouse School of Medicine gets $40 million grant to fight COVID-19: “The medical school will work with the HHS Office of Minority Health on a three-year project with community-based organizations across the nation to deliver education and information on resources to help fight the pandemic, such as testing and vaccinations once one is developed and federally-approved.”

About pharma

C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate Identification of New Uses of Existing Drugs to Treat Infectious Diseases, Including COVID-19: “Critical Path Institute (C-Path)… announced the launch of the CURE Drug Repurposing Collaboratory (CDRC) funded by the U.S. Food and Drug Administration (FDA), in collaboration with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). A public-private partnership, CDRC will provide a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. The Collaboratory will also create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world.”

US sues Regeneron over alleged kickbacks for Eylea: “The US Attorney for the District of Massachusetts announced on Wednesday that the government filed a civil complaint against Regeneron Pharmaceuticals, alleging that the drugmaker paid $35 million in kickbacks for Eylea (aflibercept), using a foundation as a conduit to cover co-pays…” This strategy is common and known to be prosecutable.

U.S. group raises pricing recommendation for Gilead's remdesivir in COVID-19: “Gilead Sciences Inc’s antiviral remdesivir could be priced up to $5,080 per course based on benefits shown in COVID-19 patients, a U.S. drug pricing research group suggested on Wednesday, above its prior recommendation of around $4,500.
The Institute for Clinical and Economic Review (ICER) said its recommendation change stemmed from recent clinical data, updated cost estimates, public comments and interactions with Gilead. 
However, Boston-based ICER suggested a lower price range of around $2,520 to $2,800, if steroid dexamethasone were to be cleared for use in COVID-19. The cheap and widely used steroid was found to reduce death rates in severely ill patients in a study earlier this month.”

About healthcare quality

National Quality Forum Releases Task Force Roadmap to Normalize High Quality Care for Every Person by 2030: The National Quality Forum (NQF) released “The Care We Need: Driving Better Health Outcomes for People and Communities, a National Quality Task Force report that provides a roadmap to consistent and predictable high quality care for every person by 2030. Underscored by the current COVID-19 pandemic, the report specifies opportunities to improve the health outcomes of people and communities with recommendations that focus on the importance of a seamless system of comprehensive, accessible care designed to keep people healthy and well.”
Included in these recommendations are five “Foundational opportunities to address structural change:

Implement a single-person identifier to match people to health records across all care settings 
Standardize quality data to enable improvement and outcomes analysis 
Adopt population health-based payment as the primary payment model 
Standardize data and interventions to reduce disparities and achieve health equity
Create actionable intelligence to better educate and engage healthcare consumers”

About health insurance

Shortchanged: How the Trump Administration’s Expansion of Junk Short-Term Health Insurance Plans is Putting Americans at Risk: This report is from the House Committee on Energy and Commerce. About 3 million Americans had short-term health plans last year, an increase of 600,000 or 27 percent from 2018. “The Committee’s investigation finds that on average, less than half of the premium dollars collected from consumers are spent on medical care, unlike ACA-compliant individual market plans, which are required to spend at least 80 percent of all premium dollars on health care.” Despite the partisan title it is a really good analysis of these types of plans.

Today's News and Commentary

About hospitals

U.S. hospitals lose legal challenge to Trump price transparency rule: “A federal judge on Tuesday dismissed a challenge by hospital groups to a federal rule requiring them to disclose prices they quietly negotiate with insurers, in a victory for White House efforts to make healthcare pricing more transparent to patients.
U.S. District Judge Carl Nichols in Washington, D.C. said the rule was reasonably related to the government’s interest in lowering healthcare costs and giving consumers more pricing data to help them decide on treatment. 
He rejected a claim by the American Hospital Association and other hospital groups that the rule would force them to disclose private negotiations with insurers, undermining competition and violating their First Amendment free speech rights.”
Recall several pharma companies won their price transparency suits because the court decided the rule overstepped CMS’s authority. Expect this decision to be appealed.

How the 3 largest nonprofit health systems fared in Q3: No surprise that all three suffered significant operating losses.

About the public’s health

Live updates: New coronavirus cases in the U.S. soar to highest single-day total: “…more than 36,000 new infections were reported by state health departments on Wednesday — surpassing the previous single-day record of 34,203 set on April 25. Texas, Florida and California led the way, with all three states reporting more than 5,000 new cases apiece.”

Feds About To Bail On Supporting COVID Testing Sites In Texas And Other States: “The Trump administration is ending funding and support for local COVID-19 testing sites around the country this month, as cases and hospitalizations are skyrocketing in many states.
The federal government will stop providing money and support for 13 sites across five states which were originally set up in the first months of the pandemic to speed up testing at the local level.”

Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association: “The addition of self-measured BP monitoring to office BP monitoring is cost-effective compared with office BP monitoring alone or usual care among individuals with high office BP…Therefore, self-measured BP monitoring has high potential for improving the diagnosis and management of hypertension in the United States. Randomized controlled trials examining the impact of self-measured BP monitoring on cardiovascular outcomes are needed. To adequately address barriers to the implementation of self-measured BP monitoring, financial investment is needed in the following areas: improving education and training of individuals and providers, building health information technology capacity, incorporating self-measured BP readings into clinical performance measures, supporting cointerventions, and enhancing reimbursement.”

When the Virus Hit, Japan Already Had an Army of Contact Tracers: Another model we should be emulating? “Experts contend that the existence of these [public health] centers, which implement and execute central public health policy from giving elderly diet advice to investigating child abuse, are one of the key reasons Japan was able to avoid an explosion in coronavirus cases.”

CVS to sell employers, universities COVID-19 testing program:”CVS Health is selling a program to employers and universities called Return Ready, which offers diagnostic testing to help them return to work and school safely. 
CVS said the program allows employers and universities to design a customized testing strategy and to choose how, where and when to test employees or students.”

Fauci gives Congress COVID-19 warning: “Fauci said time is running out to address the spikes in cases.
’Right now, the next couple of weeks are going to be critical in our ability to address those surgings that we’re seeing in Florida, in Texas, in Arizona and in other states,’ Fauci told the House Energy and Commerce Committee Tuesday.” Read the article for more on his testimony yesterday.

More Young Americans Developing Unhealthy Predictors of Heart Disease: Another reminder that COVID-19 isn’t the only pandemic. “A new study finds that 1 in 5 people under age 40 now have metabolic syndrome, a group of risk factors that together increase the odds for many serious conditions, including diabetes, heart disease and stroke. 
The rate of metabolic syndrome is rising in all age groups -- as many as half of adults over 60 have it. But among 20- to 39-year-olds, the rate rose 5 percentage points over five years, the study reported.”

U.S. and EU Officials Discuss Closer Cooperation During Pandemic

Officials discussed sharing “their common experiences and challenges in the development of COVID-19 vaccine;… extending an existing mutual recognition agreement for good manufacturing practice (GMP) inspections”…and collaborating “on COVID-19 postmarket surveillance of COVID-19 vaccines and the use of medicines in pregnant women with COVID-19.”

About health insurance

The Value of Medicaid Managed Care: States Transition to Managed Care: This study, commissioned by AHIP, is a current snapshot of the Medicaid managed care landscape. One notable statistic: 76.7% of people are enrolled in capitated arrangements. See Figure 1 for data on the rapid growth of these plans.

Insurers Not On The Hook For Diagnostic COVID Tests Mandated By Employers, Administration Rules: “Insurance companies have been anxious for guidance from the Trump administration on whether there would be patient cost-sharing responsibility for tests required by workplaces as employees return. Under the new guidance, such testing would not be covered under the Families First Coronavirus Response Act.”

CMS Unveils Major Organizational Change to Reduce Provider and Clinician Burden and Improve Patient Outcomes: CMS announced “the creation of the Office of Burden Reduction and Health Informatics to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first. The new office is an outgrowth of the agency’s Patients over Paperwork (PoP) Initiative, which is the cornerstone of CMS’s ongoing efforts to implement President Trump’s 2017 executive order to “Cut the Red Tape” and eliminate duplicative, unnecessary, and excessively costly requirements and regulations. This announcement permanently embeds a culture of burden reduction across all platforms of CMS agency operations…
Additionally, the Office of Burden Reduction and Health Informatics will focus on the important work of health informatics, which uses and applies health data and clinical information to provide better healthcare to patients.”

2019 AMA prior authorization (PA) physician survey: The graphic provides a summary of this study of 1000 physicians. Among the results: 24% say that the prior authorization (PA) process has led to a serious adverse event and 16% report that PA has led to the hospitalization of a patient.

Medical cost trend: Behind the numbers 2021: “Employer healthcare spending could fall in calendar year 2020 compared with 2019, and then rebound in 2021. How much it falls in 2020 and rebounds in 2021 is subject to many variables, complicated by the pandemic. For 2021, PwC’s Health Research Institute (HRI) has formulated three scenarios to help guide employers and health plans as they determine medical cost trend. “ Two factors that will increase spending are increases in mental health services and introduction of specialty pharmaceuticals. Cost mitigators are increases in telehealth and adoption of more narrow networks.

About healthcare IT

Anthem launching enhanced version of its Alexa Skill in 13 commercial markets: “Anthem is launching an enhanced version of its Amazon Alexa voice assistant skill across 13 of its commercial insurance markets. 
The Anthem Skill allows members to ask Alexa for assistance with several common requests, such as scheduling a call with an Anthem customer service agent or ordering prescription refills.  
Members can also seek further information about their health plans, including how close they are to meeting their deductible or the balance in their health savings account or health reimbursement account.”

About pharma

Bayer inks largest settlement in pharma history with $10B Roundup deal: “Bayer will dole out between $10.1 billion and $10.9 billion—the single largest settlement in pharma history—to put an end to thousands of lawsuits tied to its acquisition of Monsanto and glyphosate-based Roundup.”

Today's News and Commentary

About the public’s health

Activists halt street protests in South Carolina as some demonstrators become infected:”South Carolina racial justice activists said they would postpone future demonstrations or move them online after at least 13 people who took part in previous protests tested positive for the coronavirus.” Still waiting on the incubation period for other protests.

No, more testing doesn’t explain the rise of covid-19 cases in the U.S.: The headline is self-explanatory. The article goes into a deeper explanation and summary of cases across the country.

COVID-19 Hospitalizations Projected to Cost up to $17B in US in 2020: Recent calculations from Avalere.

Moody's: Patient volume recovered a bit in May, but providers face long road to recovery:”In all, the ratings agency estimated total surgeries at rated for-profit hospitals declined by 55% to 70% in April compared with the same period in 2019. States required hospitals to cancel or delay elective procedures, which are vital to hospitals' bottom lines.
Those declines narrowed to 20% to 40% in May when compared to 2019.
Emergency room and urgent care volumes were still down 35% to 50% in May.”

Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers: Most recent guidance from the FDA on which tests should and should not be used.

Judges slam J&J's 'reprehensible' talc defense, cut massive 2018 verdict to $2.11B: “For years, Johnson & Johnson has vowed to appeal each talc verdict it lost, and the company cited a ‘fundamentally unfair process’ and ‘multiple errors’ when jurors in St. Louis ordered the company to pay $4.69 billion to 22 women with ovarian cancer. 
Now, an appeals court has reduced that award—but only to $2.11 billion, thanks to J&J's "outrageous" and “reprehensible” defense of the product.
J&J brought 10 arguments in appeals, but the court found that plaintiffs ‘proved with convincing clarity that defendants engaged in outrageous conduct because of an evil motive or reckless indifference.’”

Two related stories about sugary drinks.

Health Impact and Cost-Effectiveness of Volume, Tiered, and Absolute Sugar Content SugarSweetened Beverage Tax Policies in the United States: A Microsimulation Study: “All sugar-sweetened beverage tax designs would generate substantial health gains and savings. Tiered and absolute sugar content taxes should be considered and evaluated for maximal potential gains.” Findings are not new; politics and lobbying have prevented taxes in many places where that measure has been tried.

Billions spent on ads encouraging minority youth to drink sugar-laden beverages despite health consequences: The headline speaks for itself. Time for warnings or regulation of this type of advertising?

About healthcare IT

Patients on board with health trackers but don't trust consumer wearables, survey finds: “Nearly 90% of those surveyed believe they could better manage chronic conditions with a health monitoring device. More than half of patients said they would potentially switch doctors if another doctor prescribed a specialized device, according to the survey of 2,000 people conducted by Sony.
However, while consumer-facing companies like Apple and Fitbit offer wearables with health tracking capabilities, only 28% of patients would trust a consumer device to help manage their chronic condition and 45% said they were unsure, according to the survey.”

Today's News and Commentary

About the public’s health

Coronavirus Attacks the Lungs. A Federal Agency Just Halted Funding for New Lung Treatments.:”…earlier this month, the Biomedical Advanced Research and Development Authority, or BARDA, a federal health agency, abruptly notified companies and researchers that it was halting funding for treatments for this severe form of Covid-19, the disease caused by the virus.
The new policy highlights how staunchly the Trump administration has placed its bet on vaccines as the way to return American society and the economy to normal in a presidential election year. BARDA has pledged more than $2.2 billion in deals with five vaccine manufacturers for the coronavirus, compared with about $359 million toward potential Covid-19 treatments.”
Apparently the government believes we can’t do both.

Could an Unrelated Live Attenuated Vaccine Serve as a Preventive Measure To Dampen Septic Inflammation Associated with COVID-19 Infection?: Note, this suggestion is still speculative: “There is mounting evidence that live attenuated vaccines provide nonspecific protection against lethal infections unrelated to the target pathogen of the vaccine by inducing “trained” nonspecific innate immune cells for improved host responses against subsequent infections. “

Amid threats and political pushback, public health officials are leaving their posts: “Public health workers, already underfunded and understaffed, are confronting waves of protest at their homes and offices in addition to pressure from politicians who favor a faster reopening.” This article highlights some examples.

Association of Recreational Cannabis Laws in Colorado and Washington State With Changes in Traffic Fatalities, 2005-2017: The message is…it depends. “This study found evidence of an increase in traffic fatalities after the implementation of RCLs in Colorado but not in Washington State. Differences in how RCLs were implemented (eg, density of recreational cannabis stores), out-of-state cannabis tourism, and local factors may explain the different results. These findings highlight the importance of RCLs as a factor that may increase traffic fatalities and call for the identification of policies and enforcement strategies that can help prevent unintended consequences of cannabis legalization.”

About pharma

Generic remdesivir to cost up to $79 per dose:”Two generic drugmakers, Cipla and Hetero, were given the green light from Indian regulators to market their generic versions of remdesivir, a drug that has been authorized by the FDA for emergency use in treating patients with COVID-19. 
Hetero Labs generic will be sold under the name Covifor and will cost between $66 and $79 for a 100 milligram dose, the drugmaker said.
The Cipla generic will be sold under the name Cipremi.”

Kaiser Permanente joins Civica Rx to supply generic drugs: This addition will add further strength to the consortium.

Toady's News and Commentary

About pharma

Finch Therapeutics' microbiome med quells stubborn C. difficile: This new “drug” is a therapeutic example of altering the microbiome to treat a disease. “The study pitted the drug, CP101, against placebo in 206 patients who had undergone the standard-of-care antibiotics for C. difficile infection. One dose of CP101 staved off recurrent C. difficile infections for eight weeks in nearly three-quarters of patients, compared to 62% of patients who received placebo. “ The treatment is designed to restore the gut microbes patients have lost due to antibiotics.

About the public’s health

Healthy lifestyle and the risk of Alzheimer dementia: Five risk factors/health behaviors were assessed: “non-smoking,≥150 min/wk moderate/vigorous-intensity physical activity, light to moderate alcohol consumption, high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet…, and engagement in late-life cognitive activities…
Compared to participants with 0 to 1 healthy lifestyle factor, the risk of Alzheimer dementia was 37% lower… in those with 2 to 3 healthy lifestyle factors and 60% lower… in those with 4 to 5 healthy lifestyle factors.”

AstraZeneca CEO Soriot says fast-tracked COVID-19 shot will protect for just one year: The article raises the question of how long a vaccine will be protective.

Insurers May Only Pay For Coronavirus Tests When They're 'Medically Necessary':”The Families First Coronavirus Response Act passed by Congress requires health plans to fully pay for testing deemed "medically necessary." But as testing expands enough to allow people without symptoms to be tested, a gray area is beginning to appear. 
The coverage mandate can be up to interpretation.”

CDC reports novel resistant meningococcus strain: A reminder that public health problems other than COVID-19 continue to appear.
“An analysis of meningococcus isolates from US health departments has identified a novel strain of ciprofloxacin-resistant and beta-lactamase–producing Neisseria meningitidis, scientists with the Centers for Disease Control and Prevention (CDC) and the Maryland Department of Health reported today in Morbidity and Mortality Weekly Report.
The findings prompted the CDC to issue a health advisory with recommendations for healthcare providers and public health officials.”

Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients: From the Mayo Clinic ahead of publication: “These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.”

The quest for a COVID-19 digital warning system taps smartwatches, rings and more: This article is a nice summary of the devices that are being marketed for early detection of COVID-19. I previously reported on the ring.

Guidance on Returning to Work: This monograph is from the U.S. Department of Labor Occupational Safety and Health Administration and is intended “to assist employers and workers in safely returning to work and reopening businesses deemed by local authorities as ‘non-essential businesses’ during the evolving Coronavirus Disease 2019 (COVID-19) pandemic. Employers can use this guidance to develop policies and procedures to ensure the safety and health of their employees.”

About health insurance

Medicare Advantage Plans Struggle to Communicate Effectively with Members, J.D. Power Finds: “Clear, helpful, proactive communication provided by Medicare Advantage plans to members is a key driver of overall customer satisfaction and consumer perception of trust. Overall member satisfaction increases 209 points (on a 1,000- point scale) when plans meet three key performance indicators related to information and communication: making sure members fully understand their out-of-pocket costs; providing health education; and delivering useful reminders for preventive services (emphasis added).
Missing the mark on communication: Despite the significant positive effect on member satisfaction, just 15% of Medicare Advantage plans deliver all three information and communication performance indicators.”
Read the study for more details.

5 Common & Costly Gaps in Coordination of Benefits: The short article provides a good summary of the problems that need to be addressed in order to enhance COB activity.

Effects of Medicaid Health Plan Dominance in Health Insurance Marketplaces: “In this brief [from the Urban Institute], we spoke with stakeholders in six states to assess the impact of Medicaid insurers increasing dominance in the ACA marketplaces. Overall, stakeholders said there are no longer major distinctions between Medicaid and traditional commercial insurers in the marketplace. Commercial insurers have adopted cost-containment strategies employed by Medicaid insurers including narrowing networks for more favorable provider payment rates. Medicaid insurers have started adopting commercial insurers’ practices, such as paying broker commissions, engaging in more marketing and advertising, and slowly increasing payments to providers. In doing so, stakeholders credit Medicaid insurers for increasing choice and affordability in the individual health insurance market.”

Today's News and Commentary

About pharma

CMS proposed rule aims to foster more Medicaid value-based drug agreements: CMS recognized that the Medicaid requirement for lowest supplier prices has hampered value-based pricing by other payers. This final rule gives states more flexibility for those plans to enter into value-based purchasing agreements with drugmakers based on their product’s performance. “The rule also creates minimum standards for Medicaid drug utilization programs intended to combat opioid fraud and misuse.
CMS also revised how a drugmaker must calculate the average manufacturer price of a brand-name drug that has an authorized generic.”

.WHO cuts hydroxychloroquine from COVID-19 trial again, citing lack of efficacy: “The World Health Organization (WHO) said Wednesday that the ongoing Solidarity Trial, which compares potential treatments for COVID-19, is no longer including the malaria drug hydroxychloroquine. According to Ana Maria Henao Restrepo, medical officer at the WHO's department of immunisation vaccines and biologicals, evidence from both internal and external studies ‘suggest that hydroxychloroquine, when compared with the standard of care in treatment of hospitalised COVID-19 patients, does not result in the reduction of mortality of those patients.’”

WHO: New treatment only meant for severe COVID-19 cases: “The World Health Organization (WHO) on Wednesday said a common drug shown to be effective in treating COVID-19 is meant for use only among those who are suffering the most severe symptoms of the disease, not those who have milder cases.
Scientists at the University of Oxford said Tuesday that their studies had showed dexamethasone was effective in reducing the mortality rate of severely ill patients. The study is the first to show that an already available drug is effective in reducing death rates among COVID-19 patients.”

About the public’s health

Supreme Court stops Trump from canceling DACA program: The relevant issue is the large number of DACA professionals working in healthcare. “The justices, voting 5-4 on the central issues, said the Trump administration didn’t give an adequate justification for rescinding the Deferred Action for Childhood Arrivals program. DACA, as it’s known, protects people who were brought into the country illegally as children.
Chief Justice John Roberts wrote the court’s opinion, joining the liberal justices in saying the rescission of DACA was ‘arbitrary and capricious’ in violation of a federal law that governs administrative agencies.”

Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms: “Our understanding of race has advanced considerably in the past two decades. The clinical tools we use daily should reflect these new insights to remain scientifically rigorous. Equally important is the project of making medicine a more antiracist field. This involves revisiting how clinicians conceptualize race to begin with. One step in this process is reconsidering race correction in order to ensure that our clinical practices do not perpetuate the very inequities we aim to repair.” The article is an excellent review of specific algorithm adjustments that consider race (look at the Table).

Humana: 'Healthy days' up across all Medicare Advantage markets for first time: Finally some good news (although, a bit dated in view of the past few months). “Humana saw the number of “healthy days” increase across all its Medicare Advantage (MA) markets last year, according to new data released by the insurer.
This marks the first time Humana’s seen such a result since it began tracking the metric as part of its Bold Goal initiative in 2015. Overall, Humana’s MA members saw 816,000 more healthy days than they would have without the program, according to the report.
’Healthy days’ is a population health metric developed by the Centers for Disease Control and Prevention that measures quality of life. Members are surveyed on their physical and behavioral health to track their quality of life long-term.”

Chicago has a unique COVID strain: research: “In addition to the strain from China, researchers found what appears to be the most the predominant version of the virus in the New York area and globally, the statement says. That version generates more of the virus in the upper airways than the one that’s unique to Chicago.” Differences will help clinicians understand the different ways the disease manifests itself and how to target a vaccine that covers different forms.

About health insurance

Direct Contracting Model Options: CMS announced it is accepting letters of intent for its direct contracting model, which will start in April, 2021. This CMS page provides a description of the three types of direct contracting and other program details.

Today's News and Commentary

About healthcare IT

CHIME survey shows huge increases in telehealth use: “Most healthcare executives were doing less than 25 virtual visits a day prior to the COVID-19 pandemic. The majority are now doing 50 telehealth visits a day and a full one-third of executives are doing more than 250 visits a day, according to a survey from the College of Healthcare Information Management Executives (CHIME).
Perhaps not surprising the survey of nearly 200 digital healthcare executives revealed huge increases for virtual visits and appointments.”

NIH launches platform for nationwide coronavirus patient data: “The new platform is funded by the National Center for Advancing Translational Sciences (NCATS), which is part of the NIH. It will systematically collect clinical, laboratory and diagnostic data from health care provider organizations across the country. The NIH will aggregate and harmonize the information into a standard format readily available for use by researchers and health care providers.”

HCSC partners with Epic: 3 things to know:”Health Care Service Corp., the Chicago-based parent of five Blue Cross and Blue Shield health plans, tapped Epic to launch a new health information exchange platform between insurers, providers and patients.”

About pharma

US appeals court strikes down HHS rule requiring drug prices in TV ads: “A U.S. appeals court upheld a ruling June 16 that struck down a rule from HHS requiring drugmakers to put the wholesale prices of their drugs in TV ads…
The U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the drugmakers, saying that HHS lacked the authority to establish the rule and that it acted "unreasonably" in making it.”

Common cholesterol drugs could slow spread of breast cancer to brain: “A new study from the University of Notre Dame shows drugs used to treat high cholesterol could interfere with the way breast cancer cells adapt to the microenvironment in the brain, preventing the cancer from taking hold. Patients with breast cancer who experience this type of metastasis typically survive for only months after diagnosis.

Statins, a group of drugs commonly prescribed for those with high cholesterol, were shown to interfere with a pathway that allows a cancer cell to recycle cell surface proteins and therefore make it easier for cancer cells to live within the brain.”

PBMs and Drug Spending in 2019: CVS Health and Express Scripts Outperform Prime Therapeutics: This report is a great annual analysis of drug spending. The entire article is worth reading but here is a summary: “Once again, we find that commercial drug spending did not race higher—contrary to what you keep hearing from journalists and politicians. Spending rose by less than 3% in 2019, continuing a multiyear trend of slow growth. At some plan sponsors, total drug spending even declined. For specialty drugs, higher utilization—not drug costs—was again the biggest factor driving specialty spending growth.”

About health systems

Beaumont, Advocate Aurora explore merger: “Southfield, Mich.-based Beaumont and Advocate Aurora, which has dual headquarters in Downers Grove, Ill., and Milwaukee, said they began partnership discussions in late 2019 but paused talks to allow both organizations to focus on the COVID-19 pandemic. On June 17, the health systems signed a nonbinding letter of intent to create a health system that would span across Michigan, Wisconsin and Illinois. “

7 health systems report $1B+ losses in Q1: With respect to the above article, Advocate Aurora had a net loss of $1.3B in Q1. Six other large systems’ results are listed.

About the public’s health

Two-Thirds of Patients With TNBC Do Not Receive Recommended Care: “Almost 70% of women diagnosed with triple-negative breast cancer  (TNBC) do not receive care for their disease that is in accordance with guideline recommendations from the National Comprehensive Cancer Center (NCCN), reported study results out of ASCO20 Virtual, this year’s annual meeting of the American Society of Clinical Oncology.
This despite breast cancer being the most common cancer diagnosed in women and up to 20% of all cases accounted for by the TNBC subtype, which itself is usually diagnosed between age 40 to 50 years…”

Trump health officials pledge COVID-19 vaccine will be free to the 'vulnerable': “Any potential vaccine for COVID-19 will be free for any ‘vulnerable’ American who can't afford it, Trump administration officials pledged Tuesday.”

Trump praises scientists for developing AIDS vaccine that doesn’t exist: “President Donald Trump falsely suggested that scientists have developed a vaccine for AIDS, the late stage of HIV infection in which the virus badly damages the immune system.
‘They’ve come up with the AIDS vaccine,’Trump said during a press conference on police reform, referring to scientists.” In context with other comments he was probably referring to antiretroviral drugs.

White House Left States On Their Own To Buy Ventilators. Inside Their Mad Scramble: As lack of central coordination caused states to compete for resources (like ventilators), prices increased significantly. The article provides examples.

Pandemic spurs massive declines in health spending: This Altarum study found that national health spending was 24.8% lower in April compared to April 2019. Prescription drugs increased to 13% of the total, hospital care was 26%, and physician and clinical services were 15%. Annual figures are usually 9-10%, 30% and 20%, respectively.

About health insurance

Medicaid's legislative agency reports to Congress: 5 takeaways: “The Medicaid and CHIP Payment and Access Commission released its June 2020 Report to Congress, which included recommendations on dually eligible beneficiaries, the Medicare Savings Programs and coordination between Medicaid and Tricare.”

MedPAC urges MA, ACO tweaks to speed up value-based payment reform: “Medicare Advantage and accountable care organizations could be vehicles for much needed value-based payment reform in Medicare, but not without better aligned incentives and improved quality assessment, according to the Medicare Payment Advisory Commission's June report to Congressreleased Monday.
For ACOs in the Medicare Shared Savings Program, the commission suggests HHS use national provider identifiers instead of taxpayer identification numbers. Using TINs could grant some ACOs unwarranted shared savings through favorable patient selection, MedPAC concluded.”

Today's News and Commentary

About hospitals

Best Children's Hospitals 2020-21: Honor Roll and Overview: The latest rankings from US News.

About the public’s health

Parental Hesitancy About Routine Childhood and Influenza Vaccinations: A National Survey: The need for social marketing is still great: “Almost 1 in 15 US parents are hesitant about routine childhood vaccines, whereas >1 in 4 are hesitant about influenza vaccine. Furthermore, 1 in 8 parents are concerned about vaccine safety for both routine childhood and influenza vaccines, and only 1 in 4 believe influenza vaccine is effective.”

U.S. airlines threaten to ban passengers who refuse to wear masks: “U.S. airline passengers who refuse to wear face coverings during the novel coronavirus pandemic could have their flying privileges revoked under tougher enforcement policies, the industry’s main lobby group said on Monday.”

Internal CDC memo forbids staff from speaking with Voice of America: “The April 30 internal email, which was made public in response to a Freedom of Information Act request by the Knight First Amendment Institute, stated that the CDC would not respond to interview requests from ‘anyone affiliated with Voice of America.’The email specifically cited the White House’s disapproval with the network as a reason for the decision. In April, the White House issued a statement condemning the broadcaster and accusing it of spreading Chinese propaganda…” Voice of America Director Amanda Bennett resigned today.

Individualizing Risk Prediction for Positive COVID-19 Testing: Results From 11,672 Patients: “Prediction of a COVID-19 (+) test is possible and could help direct healthcare resources. We [Cleveland Clinic researchers] demonstrate relevance of age, race, gender, and socioeconomic characteristics in COVID-19-susceptibility and suggest a potential modifying role of certain common vaccinations and drugs identified in drug-repurposing studies.”

About pharma

FDA warns hydroxychloroquine may weaken effectiveness of coronavirus drug remdesivir: Another reason to stay away from hydroxychloroquine, especially for prevention.

Potentially lifesaving coronavirus treatment dexamethasone could have ‘immediate impact,’ former FDA chief says:

• “In one study, the drug cut the risk of death by a third for Covid-19 patients on ventilators and by a fifth for those on supplemental oxygen.

• The underlying data from the study has yet to be published, but the U.K. researchers who led the trial described the results as a ‘ground-breaking.’”

3 charged in $180M scheme to fraudulently bill federal, private payers for compounded drugs: “According to the indictment, the three defendants conspired to submit the fraudulent bills between September 2011 and January 2016. Of the $180 million, $50 million was defrauded from government payers, namely Medicare and TRICARE, the DOJ said.” Note the fraud involved federal programs. It is rare that such actions involve private insurance.

Today's News and Commentary

Resource recommendation

The Managed Care Digests have been around for 34 years and provide a good source of data about providers, payers and diseases.

About pharma

FDA pulls emergency authorization for hydroxychloroquine as covid-19 treatment: “The Food and Drug Administration has withdrawn its emergency use authorization for hydroxychloroquine to treat coronavirus patients. President Trump had repeatedly promoted the antimalarial drug as a way to prevent or treat covid-19.
The agency said Monday in a statement that ‘it is no longer reasonable to believe’ the drug may be effective against covid-19 or that its benefits outweigh ‘known and potential risks.’”

Promising path found for COVID-19 therapeutics: As the biology of SARS-CoV-2 becomes clearer, a number of new therapies can be investigated. This article explains one of them.

Physicians, nurses and pharmacists among 19 indicted in multimillion-dollar opioid distribution ring: The opioid epidemic is not over as long as theses schemes persist. “The indictment alleges clinic owner John Henry Rankin gave money and illegal benefits to physicians and nurse practitioners who wrote faulty prescriptions for oxycodone, hydrocodone, promethazine with codeine cough syrup and other highly addictive drugs. The court document also accuses Mr. Rankin of recruiting patients into the conspiracy and paying an unlicensed medical worker to issue fraudulent prescriptions while posing as a physician.
The court has accused the distributors of prescribing nearly 2 million illegal doses of Schedule II controlled substances, with the oxycodone and oxymorphone alone holding a conservative street price of more than $41 million.”

About the public’s health

Trump administration revokes transgender health protection:”The Department of Health and Human Services said it will enforce sex discrimination protections ‘according to the plain meaning of the word ‘sex’ as male or female and as determined by biology.’This rewrites an Obama-era regulation that sought a broader understanding shaped by a person’s internal sense of being male, female, neither or a combination.” This announcement preceded today’s ruling by the Supreme Court that sexual orientation could not be the basis of discrimination in the workplace.

Record spikes in new coronavirus cases, hospitalizations sweep parts of U.S.:”New coronavirus cases and hospitalizations in record numbers swept through more U.S. states, including Florida and Texas, as most push ahead with reopening and President Donald Trump plans an indoor rally in Tulsa, Oklahoma…
Nationally, there were over 25,000 new cases reported on Saturday, the highest tally for a Saturday since May 2, in part due to a significant increase in testing over the past six weeks.”

Beijing imposes curbs as coronavirus returns to Chinese capital:”Several districts of the Chinese capital put up security checkpoints, closed schools and ordered people to be tested for the coronavirus on Monday after an unexpected spike of cases linked to the biggest wholesale food market in Asia.
After nearly two months with no new infections, Beijing officials have reported 79 cases over the past four days, the city’s biggest cluster of infections since February.”

How to Use Masks during the Coronavirus Pandemic: A good reminder from Scientific American about how to use a mask effectively.

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers: The new version protects against an additional 5 strains of HPV. Those previously immunized will probably receive a course of this vaccine as well.

The $7,000 Covid test: Why states are stepping in to shield consumers: “Insurance regulators from Tennessee to Washington state have stepped up efforts to protect patients from unexpected bills for coronavirus tests, concerned the federal government has failed to shield people from thousands of dollars in out-of-pocket expenses…
The state-by-state guidance and rules come after Congress and the Trump administration this spring assured Americans that coronavirus testing and any necessary trips to doctors and hospitals would be free. But lawmakers didn't limit charges if the testing is done out of network — or prohibit labs or hospitals from billing patients if insurers refuse to pay their posted charges.
Employers and health plans have complained this could lead to staggering costs. One national insurer was billed $6,946 for a coronavirus test in Texas, according to claims data reviewed by POLITICO.”

Coronavirus survival comes with a $1.1 million, 181-page price tag: “The bill is technically an explanation of charges, and because Flor [the patient] has insurance including Medicare, he won’t have to pay the vast majority of it. In fact because he had COVID-19, and not a different disease, he might not have to pay anything…” Recall many insurers have waived out of pocket expenses for COVID-19 related conditions, including testing (see article above).

About healthcare IT

The bipartisan HEALTH Act would make permanent Medicare payments for telehealth services at federally qualified health centers and rural health clinics: The temporary reimbursement changes for telehealth may become more permanent. “U.S. Reps. G.K. Butterfield, D-North Carolina, and Glenn Thompson, R-Pa., introduced new legislation this week that would provide for permanent Medicare payments for telehealth services at federally qualified health centers and rural health clinics. 
The Helping Ensure Access to Local TeleHealth, or HEALTH Act, would require the Secretary of Health and Human Services to revise the Code of Federal Regulations to consider telehealth services from an eligible facility to be a ‘visit.’”

FCC Funds 67 More COVID-19 Telehealth Projects, Program Surpasses $100M in Funding: ”The FCC Wireline Competition Bureau has announced the next tranche of approved projects in the COVID-19 telehealth program. The new funding of $20.18 million is for 67 projects. This brings total funding to $104.98 million for 305 providers in 42 states and the District of Columbia. The $200 million COVID-19 telehealth program was created in the CARES Act, which was approved in March.”

10 common reasons for HIPAA violations: “In the past 12 months, there were 393 protected health information breach incidents reported to HHS.” This article is a good summary of the types of infractions with many examples.

Health systems can use PHI to contact former COVID-19 patients on blood, plasma donation without violating HIPAA: 3 details: And here is guidance about what you can do and not violate HIPAA.

Beyond Convenience: Patients’ Perceptions of Physician Interactional Skills and Compassion via Telemedicine:”This [research] supports the notion that clinician-patient relationships can be established in a video-first model, without a previous in-person encounter, and that positive ratings do not seem to be focused solely on prescription receipt.”

About healthcare professionals

Accountable Care Organizations’ Increase In Nonphysician Practitioners May Signal Shift For Health Care Workforce: For the period 2013-2018: “The average proportion of nonphysician practitioners in ACOs grew from 18.1 percent to 38.7 percent, with a commensurate decline in the average share of primary care physicians from 60.0 percent to 42.2 percent. As value-based care models grow in prevalence, their evolving clinician composition may affect workforce patterns in the broader health care delivery system.”

Healthcare Professionals and the Impact of COVID-19: ”Nationally, from March 2019 to March 2020, utilization of professional services decreased 65 percent and professional revenue based on total estimated allowed amounts decreased 45 percent. From April 2019 to April 2020, utilization fell 68 percent and revenue 48 percent.” This article goes into more details and especially highlights specialties that were particularly affected. For example, oral surgery and gastroenterology were the most impacted.

Today's News and Commentary

About the public’s health

Two policy pieces worth reading by leaders in the healthcare field:

Health Care Policy After the COVID-19 Pandemic by Victor Fuchs

The Moral Determinants of Health by Donald Berwick

Prevalence of Gastrointestinal Symptoms and Fecal Viral Shedding in Patients With Coronavirus Disease 2019: “These findings suggest that that 12% of patients with COVID-19 will manifest GI symptoms; however, SAR-CoV-2 shedding was observed in 40.5% of patients with confirmed SARS-CoV-2 infection. This highlights the need to better understand what measures are needed to prevent further spread of this highly contagious pathogen.”

Lack of Health Literacy a Barrier to Grasping COVID-19: The headline speaks for itself. The article is a good explanation of the problem and possible solutions.

Models show rising US COVID-19 cases, deaths in months ahead: “The model produced by the Institute for Health Metrics and Evaluation, influential among members of the White House coronavirus task force, updated its projection of fatalities due to the novel coronavirus, showing the US death toll could reach 169,890 by Oct 1. That model shows a second wave of fatal infections, with deaths from the virus dropping off in July and August before rising sharply at the end of September and worsening through October and November.”

As Coronavirus Infections Climb, Washington Moves On to Other Business: Despite the above prediction for a second wave, “there seems to be a tacit agreement between the parties: Democrats have largely stopped harping on social distancing, while Mr. Trump plans to resume his political rallies  — first in Oklahoma, Florida, Arizona and North Carolina — and Republicans refrain from shaming protesters over shedding pandemic precautions.” Of note is that the tickets for Trump’s Tulsa rally have a disclaimer about COVID-19 that is meant to shield organizers from liability.

Trends in Frequency of Sexual Activity and Number of Sexual Partners Among Adults Aged 18 to 44 Years in the US, 2000-2018: “This survey study found that from 2000 to 2018, sexual inactivity increased among US men such that approximately 1 in 3 men aged 18 to 24 years reported no sexual activity in the past year. Sexual inactivity also increased among men and women aged 25 to 34 years. These findings may have implications for public health.”

Association Between Breastfeeding and Ovarian Cancer Risk: Encouragement for breastfeeding is often framed as benefits to the baby. Here is another good reason. “Breastfeeding is associated with a significant decrease in risk of ovarian cancer overall and for the high-grade serous subtype, the most lethal type of ovarian cancer. The findings suggest that breastfeeding is a potentially modifiable factor that may lower risk of ovarian cancer independent of pregnancy alone.”

Antibody testing suggests immune response post-COVID is very variable: “A bunch of recent draft papers have looked at the sort of immune response we're seeing in patients who have cleared the virus after testing positive for it. And the results suggest that it's very variable—as is the quality of the tests that detect it.”

Rwandan researchers discover new rare tuberculosis strain: Let’s see what we do with this information in light of what we have learned about early detection of possible pandemic-related pathogens.

'Surprisingly rapid' rebound in carbon emissions post-lockdown: Because of COVID-19-related reduced travel and other activities, carbon emissions declined significantly. Now that restrictions are relaxing, the rebound in these emissions is occurring more rapidly than expected.

About pharma

FDA approves Nyvepria, biosimilar to pegfilgrastim, to reduce infections:”Pegfilgrastim-apgf (Nyvepria, Pfizer) — a biosimilar to pegfilgrastim(Neulasta, Amgen) — is indicated to reduce infections manifested by febrile neutropenia among patients who receive nonmyelosuppressive anticancer drugs such as chemotherapy that can cause fever and low white blood cell count.” Its introduction could significantly lower treatment costs.

Free samples of prescription drugs cannot be given to pharmacists, EU court rules: “The European Union's Court of Justice on Thursday ruled that free samples of prescription medicines cannot be given to pharmacists, following a request for clarification on the matter by Novartis. The court determined that European directives only allow those entitled to prescribe drugs, namely doctors, to receive free samples, citing the risks associated with their use or the uncertainty of their effects without proper medical supervision.”

Hedge fund manager stands to profit on ‘flip’ of taxpayer-funded coronavirus drug: “The perception that companies are profiteering during a global medical crisis — especially in cases where inventions were funded by taxpayers — poses political dangers to the pharmaceutical industry.” This article is a case study about how this problem is playing out.

Gilead should be allowed 'real pricing' for remdesivir—and a sizable profit, analyst says: “‘If you are going to war, or preparing for war in a capitalist country, you have to let business make money out of the process or business won’t work,’ SVB Leerink’s Geoffrey Porges wrote in a Wednesday note to investors, quoting former U.S. Secretary of War Henry Stimson during World War II…
What kind of a sticker price for remdesivir is acceptable? Around $5,000 per course, in Porges’ view. That was roughly the same as the $4,460 that drug cost watchdog the Institute for Clinical and Economic Review (ICER) came up with recently for the drug to be deemed cost-effective.”

Today's News and Commentary

About pharma

U.S. states accuse 26 drugmakers of generic drug price fixing in sweeping lawsuit: “The lawsuit accused Novartis’ Sandoz unit, Teva Pharmaceuticals’ Actavis unit, Mylan, Pfizer Inc and other drugmakers of conspiring to rig the market between 2009 and 2016 for more than 80 drugs. 
Attorneys general from 46 states, the District of Columbia and four U.S. territories said the defendants prioritized profit over the public interest, depriving millions of consumers of lower prices for needed medication. 
Ten executives, including many sales and marketing directors, are also defendants in the 543-page complaint filed in a federal court in Connecticut.”

Cigna sues dozens of drugmakers in alleged price-fixing scheme: On a similar note: “The lawsuit, filed June 9 in a Pennsylvania district court, alleges the drugmakers conspired to fix, increase, stabilize or maintain prices of generic drugs, allocate customers and markets and rig bids for generic drugs in violation of federal and state antitrust and competition laws.”

What's the ROI on a COVID-19 vaccine? We have no idea, says Pfizer: The development cost and price of the vaccine are not yet known, so the projected ROI cannot be calculated. The interesting story here is how the vaccine is being developed and how it will be rolled out.

340B Program Reached $29.9 Billion in 2019; Now Over 8% of Drug Sales:”According to data provided to Drug Channels by the Health Resources and Services Administration (HRSA), discounted 340B purchases were at least $29.9 billion in 2019. That figure is an astonishing 23% higher than its 2018 counterpart. Since 2014, purchases under the 340B program have tripled.”

Pharmacist-Recommended Product Rankings: “Thousands of pharmacists nationwide were surveyed to pinpoint their recommendations on a range of over-the-counter products. U.S. News, in collaboration with Pharmacy Times, has compiled their responses to show how different brands stack up in more than 130 over-the-counter product categories.”

Personalized Mapping of Drug Metabolism by the Human Gut Microbiome: “The human gut microbiome harbors hundreds of bacterial species with diverse biochemical capabilities. Dozens of drugs have been shown to be metabolized by single isolates from the gut microbiome, but the extent of this phenomenon is rarely explored in the context of microbial communities. Here, we develop a quantitative experimental framework for mapping the ability of the human gut microbiome to metabolize small molecule drugs: Microbiome-Derived Metabolism (MDM)-Screen.”

About healthcare IT

Frequency and Types of Patient-Reported Errors in Electronic Health Record Ambulatory Care Notes: “In this survey study of 136 815 patients, 29 656 provided a response, and 1 in 5 patients who read a note reported finding a mistake and 40% perceived the mistake as serious. Among patient-reported very serious errors, the most common characterizations were mistakes in diagnoses, medical history, medications, physical examination, test results, notes on the wrong patient, and sidedness…
Older and sicker patients were twice as likely to report a serious error compared with younger and healthier patients, indicating important safety and quality implications. Sharing notes with patients may help engage them to improve record accuracy and health care safety together with practitioners.”

FCC Proposes $225M Fine for Spoofed Robocalls and State AGs Follow Suit: “Continuing its campaign against illegal robocalls, particularly the spoofed variety, the Federal Communications Commission (FCC) on June 9, 2020, proposed a $225 million fine – the “largest in the FCC’s 86-year history” – against Texas-based health insurance telemarketers for apparently making approximately 1 billion illegally spoofed robocalls.”

QR codes could provide patients way to keep them out of emergency rooms: Putting a QR code on a child’s cast so parents could scan it for instructions was found to reduce ER visits.

About the public’s health

Annual costs for diagnostic tests up to $25B, antibody tests up to $19B: “The estimated annual cost for diagnostic testing of COVID-19 will range from $6 billion to $25.1 billion, and the cost for antibody testing could vary from $5.2 billion to $19.1 billion, a new study found…
The estimates include both the costs for providing the test itself and any other affiliated healthcare costs like a trip to urgent care.”

Virologists vigorously debunk new study on origins of the novel coronavirus: “Despite overwhelming scientific consensus that the novel coronavirus came from nature, various scientific and pseudo-scientific claims have continued to fan the flames of a conspiracy theory that the virus was engineered in a Chinese lab.”

Coronavirus vaccine developers have a ‘bizarre’ problem. There’s not enough sick people:”The top teams rushing to develop coronavirus vaccines are alerting governments, health officials and shareholders that they may have a big problem: The outbreaks in their countries may be getting too small to quickly determine whether vaccines work..”

J&J moves up COVID-19 vaccine trial to second half of July: The successful trials are going so well that the company is moving up its timetable by two months.

Coronavirus Vaccine Candidates’ Pivotal U.S. Testing to Start This Summer: Other companies are also progressing rapidly on vaccine development.

Moderna, Merck execs see possible speed bumps in COVID-19 vaccine manufacturing:”…behind the scenes, execs at some of the leading players are intensely focused on the details needed to produce the candidates on a massive scale.
For instance? Sourcing raw materials and assembling the labor force needed to produce hundreds of millions of shots in record time, execs for Moderna and Merck said at BIO’s digital conference this week.”

Third of Americans Say They Won't Get a COVID-19 Vaccine, with Black Americans the Most Skeptical: Vaccine development and manufacturing are only the first parts to the solution. “Of the 1,003 U.S. adults who took part in the nationally representative telephone survey, 29 percent said they definitely would get a vaccine if and when one becomes available, while 35 percent said they are unlikely to or definitely would not.”

Association Between Adult Acne and Dietary Behaviors: “In this study, consumption of milk, sugary beverages, and fatty and sugary products appeared to be associated with current acne in adults. Further large-scale studies are warranted to investigate more closely the associations between diet and adult acne.”

Association of Low-Value Testing With Subsequent Health Care Use and Clinical Outcomes Among Low-risk Primary Care Outpatients Undergoing an Annual Health Examination: “Low-value care, or health care services that do not improve patient outcomes or for which harms appear to outweigh the benefits, is estimated to cost the US health care system between $75.7 and $101.2 billion annually.”
This study only looked at overuse of three tests: chest x-rays, an electrocardiogram (ECG) and Papanicolaou (PAP) test done as part of an “annual health exam.” The point of this study was to show that when these tests are done on low risk patients, a large number of unnecessary tests and consultations result.

About health insurance

18 Million Americans Lack Adequate Health Insurance While Facing Greater Risk of Severe Coronavirus, Study Finds: “More than 18 million Americans, most of whom are minorities and low-income individuals, are uninsured or underinsured while also being at increased risk of developing severe cases of COVID-19, a new study by researchers at Harvard Medical School and CUNY's Hunter College has shown.”

Certain Medical Care Arrangements: “This document contains proposed regulations relating to section 213 of the Internal Revenue Code (Code) regarding the treatment of amounts paid for certain medical care arrangements, including direct primary care arrangements, health care sharing ministries, and certain government-sponsored health care programs. The proposed regulations affect individuals who pay for these arrangements or programs and want to deduct the amounts paid as medical expenses under section 213.”
For a summary and analysis of the regulations, see: New Proposed Rule On Health Care Sharing Ministries And Direct Primary Care.

Today's News and Commentary

About hospitals

COVID-19 shouldn't lead to 'opportunistic' health mergers, biz groups say: “Now that healthcare providers have received billions in federal aid to offset their COVID-19 losses, some business groups, regulators and lawmakers want to ensure the money doesn’t fuel a wave of predatory consolidation.” 
For example: “The Pacific Business Group on Health, a consortium of 41 private employers and public purchasers that together spend $100 billion annually providing healthcare to 15 million people, has asked Congress to make healthcare providers pledge not to engage in M&A for 12 months as a condition of receiving aid from the Coronavirus Aid, Relief, and Economic Security Act.”

Henry Ford, Michigan State sign affiliation letter of intent: “Henry Ford Health System in Detroit and Michigan State University in East Lansing have signed a nonbinding letter of intent to create a primary affiliation to share research and clinical care, increase health student education and develop a long-term plan to build a joint research institute in Detroit.”

About healthcare IT

UnitedHealth execs: Patients are using telehealth for convenience, not as a necessity: “According to data from UnitedHealth Group and consumer research company CivicScience, 29% of consumers said they used telehealth in May up from 8% in December. The percentage of consumers who don't plan to use telehealth dropped from 72% in December to 47% in May, according to a consumer poll.
While COVID-19 visits accounted for nearly 1 in 5 virtual visits in March, that dropped to only 4% of visits in May.
In March, less than half (45%) of consumers cited convenience and speed as their primary reasons for using the technology, and that grew to 66% in May.”

About the public’s health

Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: “…if States or regions have determined with their public health officials that they passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I, and subsequently to Phase II of re-opening.” This site has CMS guidelines for the re-openings.

Does Speaking Japanese Lower The Risk of Spreading Coronavirus? This article is really interesting.

Price Limits Will Scare Off Covid Vaccine Makers, Fauci Warns: “Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the US government should not force drugmakers to lower the costs of COVID-19 vaccines and treatments, but should encourage fair pricing…”

COVID-19–linked syndrome in kids new, distinct, studies suggest: “Two new studies involving a total of 75 children published yesterday in JAMA showed that the pediatric multisystem inflammatory syndrome linked to COVID-19 is novel and different from Kawasaki disease (KD) and toxic shock syndrome (TSS).” The links to the studies are in the article.

This past week, the WHO was not at its best. Here are two articles that explain the issues very well:

WHO Creates 'Confusion' About Asymptomatic Spread. Here's What We Know: The WHO has backtracked on its statement that coronavirus transmission by asymptomatic people is rare.

Who’s to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal: With respect to the previously-reported withdrawn studies about hydroxychloroquine, this article provides an in-depth profile of the principals behind the scandal.

International Health Care System Profiles: The Commonwealth Fund just published its latest update on 20 international healthcare systems. It is a great resource for this topic.

About health insurance

The Implications of Medicaid Expansion in the Remaining States: 2020 Update: “Even absent the current COVID-19-related economic crisis, if the 15 holdout states had expanded Medicaid eligibility as envisioned under the ACA, 3.9 million fewer people would have been uninsured.”

Today's News and Commentary

About the public’s health

WHO says asymptomatic people usually don't spread coronavirus. Experts doubt that.: This story is all over the media because of its implications on containing the outbreak. Here is the essence of the debate: “ key experts in the United States say the WHO's conclusion presents some big problems. 
It's not that asymptomatic people don’t spread the virus — but that contact tracing is simply bad at detecting it, they argue. The studies cited by WHO relied on only a small number of people in China who claimed to have gotten sick from someone who had symptoms – which is not exactly a rigorous scientific experiment.
They also worry that their findings will lead to confusion.There's a difference between people who truly never showed symptoms of coronavirus and people who were ‘pre-symptomatic,’ who had not yet developed symptoms but eventually would. Then, of course, there are ‘low-symptomatic’ people who are experiencing effects of coronavirus so mild they might not be noticed.”

When 511 Epidemiologists Expect to Fly, Hug and Do 18 Other Everyday Activities Again: The NY Times asked 511 epidemiologist when they expected to re-engage in a number of activities. The answers make interesting reading.

Negative thinking linked to dementia in later life, but you can learn to be more positive: Really, don’t worry, be happy. “A new study found that repetitive negative thinking in later life was linked to cognitive decline and greater deposits of two harmful proteins responsible for Alzheimer's disease.”

FDA authorizes COVID-19 saliva test by Phosphorus Diagnostics: “The U.S. Food and Drug Administration on Monday allowed emergency use of a COVID-19 saliva test made by privately held Phosphorus Diagnostics LLC that allows people to send in their saliva samples to the company’s laboratory for testing. 
The company’s sample collection kit, priced at around $140, would be delivered to customers if they are found eligible after completing an online questionnaire.”

Poll: Pandemic does little to alter US views on health care: This AP-NORC poll “found that people are more likely to trust private entities over government at driving innovation in health care (70% to 28%), improving quality (62% to 36%) and providing insurance coverage (53% to 44%). Americans had more confidence in government’s ability to reduce costs, preferring it over the private sector 54% to 44%. All of those preferences are unchanged since before COVID-19 arrived…
While about 3 in 5 said they were very or extremely concerned about Americans in general having access to high quality care, people were less likely than in February to say they were greatly concerned about having access to quality care for themselves (46% to 58%) and about their own health care spending (35% to 44%).”

Social distancing across vulnerability, race, politics, and employment: How different Americans changed behaviors before and after major COVID-19 policy announcements: When it comes to motivating people to social distance practices, one size does not fit all. This research found that the “variation in behavioral drivers including vulnerability, race, political affiliation, and employment industry demonstrates the need for targeted policy messaging and interventions tailored to address specific barriers for improved social distancing and mitigation.”

CMS testing guidelines for uninsured: 5 things to know: “CMS issued a document that outlines state requirements for covering the cost of COVID-19 testing for uninsured Americans, and lists flexibilities that states can use to meet the requirements. “

CDC wants states to count ‘probable’ coronavirus cases and deaths, but most aren’t doing it: “Fewer than half the states are following federal recommendations to report probable novel coronavirus  cases and deaths, marking what experts say is an unusual break with public health practices that leads to inconsistent data collection and undercounts of the disease’s impact.
A Washington Post review found that the states not disclosing probable cases and deaths include some of the largest: California, Florida, North Carolina and New York.”

About pharma

AbbVie's Humira defense may keep prices high, but it's still legal, judge rules: “While AbbVie’s deals with biosimilar companies preserve high prices in the U.S. for several years, the company's strategy doesn't amount to an antitrust violation, U.S. District Judge Manish Shah wrote in an order Monday. “ The strategy the company is using is called a patent thicket. “With that thicket, the company sued companies seeking to market biosimilars and then inked deals to keep competing products off the U.S. market until 2023. As part of those deals, AbbVie gave biosim companies permission to launch in Europe despite existing patents there…”

Stanford team deploys CRISPR gene editing to fight COVID-19: “Bioengineers at Stanford University were working on a system to fight the flu with the gene-editing technology CRISPR when the COVID-19 pandemic emerged in January. So they quickly pivoted to address the new disease—and now they’re reporting they’ve developed a way to inhibit 90% of coronaviruses, including SARS-CoV-2, the cause of COVID-19.”

As COVID-19 social media fatigue sets in, pharma begins to restart other health conversations: “COVID-19 fatigue is setting in with many people, and for pharma companies, that means an opportunity to return to social media messages on other health topics.
Evoke Kyne and its new social media chief Kate Callan have been tracking social media conversations throughout the crisis, and the latest numbers show a 65% drop in global conversations around COVID-19, from 204 million weekly mentions in mid-March to just 71 million in late May. The mood around those conversations is also shifting away from disgust, which is still the top feeling at 34%, toward feelings such as anticipation, now at trending at 15% of the conversation mood.”

About hospitals

World’s best hospitals 2020: In this Newsweek list, five of the top six hospitals are in the US.

About health insurance

N.Y. insurers request nearly 12% increase in premiums: “New York insurers selling plans to individuals asked the state to raise rates by a weighted average of 11.7% with some citing COVID-19 as necessitating higher premiums in 2021.
Oscar sought the largest premium increase on average in the individual market at 19.1%…”

Today's News and Commentary

About healthcare IT

GAO: Mar-a-Lago members acted as advisers on VA initiatives, including $16B Cerner EHR contract: “Three members of President Donald Trump's inner circle acted as advisers by making recommendations on a number of key Department of Veterans Affairs (VA) initiatives, including the Cerner contract, a government watchdog said.
A Government Accountability Office (GAO) report publicly released this week said a review of email exchanges between Florida physician Bruce Moskowitz, Marvel Entertainment Chairman Isaac Perlmutter and financial consultant Marc Sherman indicated the three interacted with VA and other federal officials frequently—at times daily, according to former VA officials—through email and telephone, the GAO wrote.
’The three private citizens acted as advisors by making recommendations regarding, for example, the Cerner contract negotiation, mobile application development, and potential candidates for senior-level VA positions,’ according to the report.”

About healthcare personnel

Hospitals continue to struggle with job losses as other areas of healthcare rebound in May:”Healthcare employment increased by 312,000 in May, but hospitals still lost 27,000 jobs, according to a report issued today from the U.S. Bureau of Labor Statistics.
Job losses continued for hospitals and also for nursing and residential care facilities, which lost 37,000 jobs.
Physicians saw an increase of 51,000 jobs, and dentists and other health practitioners saw increases of 245,000 and 73,000, respectively.”

About the public’s health

Gargling with bleach? Americans misusing disinfectants to prevent coronavirus, survey finds: “More than a third of Americans misused cleaners and disinfectants to try to prevent infection by the coronavirus, according to a survey taken shortly after President Donald Trump publicly asked whether injecting such products could treat COVID-19. 
Washing food with bleach, using household cleaning or disinfectant products on bare skin, and intentionally inhaling or ingesting these products were some of the most commonly reported ‘high-risk’ practices in a May 4 online survey of 502 U.S. adults, the Centers for Disease Control and Prevention (CDC) reported.”

And on a related note: Bleach baths and drinking hand sanitiser: poison centre cases rise under Covid-19: The headline speaks for itself. The article has more of an international scope than the one above.

Associations of Flavored e-Cigarette Uptake With Subsequent Smoking Initiation and Cessation: “Vaping uptake was positively associated with smoking initiation in youth…and in emerging adults... Vaping uptake was associated with cessation in adults…
adults who vaped flavored e-cigarettes were more likely to subsequently quit smoking than those who used unflavored e-cigarettes.”

The effect of large-scale anti-contagion policies on the COVID-19 pandemic: The researchers estimate that these well-known measures employed “across these six countries… prevented or delayed on the order of 62 million confirmed cases, corresponding to averting roughly 530 million total infections.” Of those prevented infections, an estimated 62 million were in the US.

Cuba sets example with successful programme to contain coronavirus: “While the WHO has signaled that Latin America is the new centre of the pandemic, cases in the Communist-ruled island have fallen for two months.” Cuba’s primary care system is a model for public health initiatives.

Coronavirus: WHO advises to wear masks in public areas: The important recommendation that is really new is: Fabric masks should consist of "at least three layers of different material" in order to be effective.

With No Current Cases, New Zealand Lifts Remaining COVID-19 Restrictions: A further reminder what a successful program looks like: “New Zealand Prime Minister Jacinda Ardern says the country has officially eradicated COVID-19 and will return to normal after the last known infected person recovered.
Isolation and quarantine for those arriving from abroad will continue.”

BARDA taps Evidation Health to digitally monitor healthcare workers for early COVID-19 symptoms:”The project will receive funding support from the Biomedical Advanced Research and Development Authority (BARDA) as well as the Bill & Melinda Gates Foundation.
Evidation plans to gather behavior and symptom data—including sleep and activity patterns from wearable devices, plus self-reported health issues—from 300 people with a high risk of being exposed to and possibly contracting the disease, such as healthcare workers and first responders.”

Repositioning of the global epicentre of non-optimal cholesterol:”…countries with the highest level of non-HDL cholesterol—which is a marker of cardiovascular risk—changed from those in western Europe such as Belgium, Finland, Greenland, Iceland, Norway, Sweden, Switzerland and Malta in 1980 to those in Asia and the Pacific, such as Tokelau, Malaysia, The Philippines and Thailand. In 2017, high non-HDL cholesterol was responsible for an estimated 3.9 million (95% credible interval 3.7 million–4.2 million) worldwide deaths, half of which occurred in east, southeast and south Asia.”

California and Some Other States See Coronavirus Cases Rise:”Nearly three months since the U.S. declared a national emergency over the new coronavirus, some states are reporting a rise in new cases as they lift restrictions meant to slow the virus’s spread.
California, Utah, Arizona, North Carolina, Florida, Arkansas and Texas, among others, have all logged rises in confirmed cases, according to a Johns Hopkins tabulation of a five-day moving average. Meantime, New York City, the U.S. area hit hardest by the pandemic, has seen a drop in cases and deaths and plans to begin reopening its economy Monday.”

About pharma

The US government's supply of the only proven Covid-19 drug runs out at the end of the month: “The US government's current supply of remdesivir, the only drug known to work against Covid-19, will run out at the end of the month, Dr. Robert Kadlec, a US Department of Health and Human Services official, told CNN. 
The government's last shipment of the drug will go out the week of June 29. Gilead Sciences, the company that makes the drug, is ramping up to make more, but it's unclear how much will be available this summer.”

The top 10 pharma R&D budgets in 2019: A good summary of who is working on what and how much they are spending. Roche heads the list.

Optum says payers should keep a close eye on these 3 drugs. Here's why: All three are orphan drugs.

About health insurance

COVID-19 Cost Scenario Modeling: Treatment: Wakely prepared this latest update for AHIP, estimating costs of COVID-19 to the insurance industry. “Our previous report estimated the direct impact of COVID treatment costs to be between $56 and $556 billion, while the updated analysis estimates costs of $30 to $547 billion. Incorporating deferred care with the treatment costs generally decreases the overall impact to insurers, resulting in a total impact of between -$76 and $216 billion for 2020 and 2021 combined.”

Today's News and Commentary

About healthcare professionals

Where Is the ID in COVID-19?: “Among the 785 counties with the highest quartile of COVID-19 disease burden… 521 (66.4%) have no ID [Infectious Disease] physician coverage.” This finding highlights shortages must not only be measured in sheer numbers but in geographic distribution, especially in areas of need.

About the public’s health

For your amusement:
Isaac Newton proposed curing plague with toad vomit, unseen papers show: The headline speaks for itself but the story is interesting.

HHS updates COVID-19 lab test data reporting requirements: 6 details:”HHS updated its guidance on the data that should be reported by laboratories as part of the COVID-19 test results…’The requirement to include demographic data like race, ethnicity, age, and sex will enable us to ensure that all groups have equitable access to testing, and allow us to accurately determine the burden of infection on vulnerable groups,’ said ADM Brett P. Giroir, MD, Assistant Secretary for Health..’” The requirements start August 1.

Singapore plans wearable virus-tracing device for all: “Singapore plans to give a wearable device that will identify people who had interacted with carriers of coronavirus to each of its 5.7 million residents, in what could become one of the most comprehensive contact-tracing efforts globally. 
Testing of the small devices, which can be worn on the end of a lanyard or carried in a handbag, follows limited take-up of an earlier smartphone-based system and has further fuelled privacy concerns about contact tracing technology.”

Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study: The FDA updated its approved test list. The list started last month; now two have been voluntarily removed.

Is Cardiovascular Disease Slowing Improvements in Life Expectancy?: From the King’s Fund and the OECD:

“Improvements in life expectancy at birth observed before the COVID-19 epidemic had slowed considerably in most OECD countries in recent years. Longevity gains fell on average 25%, when comparing the period between 2012 and 2017 to a decade earlier. One reason behind this is that cardiovascular disease (CVD) mortality improvements are now substantially lower than what they used to be in some countries. CVD is a major killer in OECD societies, causing many preventable deaths and large social inequalities…
Several reasons underpin this trend. For a start, the prevalence of underlying lifestyle risk factors that cause CVD is rising. Rising trends in obesity and diabetes are estimated to offset the mortality reductions attributed to favourable changes in smoking. OECD estimates that overweight-related diseases will reduce life expectancy by nearly three years by 2050, without further policy action. Furthermore, newly emerging risk factors are contributing to higher CVD mortality, like drug overdose and air pollution. Severe influenza outbreaks in some recent winters, as in 2014-15, could also have impacted on CVD mortality, as influenza and pneumonia can trigger cardiovascular events like heart attacks, and in turn, individuals with CVD may be more susceptible to dying from influenza or pneumonia.”

About health insurers

Anthem offering $2.5B in financial assistance to members, providers impacted by COVID-19: “Anthem will make premium credits of between 10% and 15% available to select individual market plans and fully insured commercial plans. Members enrolled in standalone and group dental plans will receive a 50% credit, Anthem announced Thursday. 
The credits will be provided in July, Anthem said.”

UnitedHealth invests $100M in building affordable housing: “UnitedHealth Group is investing $100 million in building affordable housing units that will also include on-site health services. 
The funding will build 1,000 homes for families and seniors in partnership with Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. The initial batch of units will include 100 apartments in Washington, D.C., 40 apartments in Wharton, Texas, and 30 apartments in Choctaw, Oklahoma. 
UnitedHealth will also put $1 million toward on-site health and wellness services and tracking how access is impacting residents’ health.”

About pharma

Mylan and Lupin Receive European Clearance for Etanercept Biosimilar: “The approval was based on a biosimilarity assessment that demonstrated bioequivalence to Enbrel. In addition, a phase 3 trial in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel for safety, efficacy and immunogenicity.” A continued trend toward biosimilars will bring costs down.

Today's News and Commentary

About pharma

WHO to restart hydroxychloroquine trial after Chicago company’s data questioned: “An international trial using hydroxychloroquine to treat COVID-19 patients will be restarted after questions arose about a study linking the antimalarial drug to increased death and heart risks….
The move adds to the confusion that’s erupted since more than 200 scientists began questioning the study published May 22 [in The Lancet]. Scrutiny has focused on Surgisphere Corp., the Chicago-based firm that provided data for the investigation, with demands for more transparency about its sources and methods of analysis.”
This afternoon, the authors of The Lancet study withdrew their article.

About the public’s health

The C.D.C. Waited ‘Its Entire Existence for this Moment.’ What Went Wrong?: This article from The NY Times has been widely cited in other media outlets and is a great review of the headline topic.

Impact of the COVID-19 Pandemic on Emergency Department Visits — United States, January 1, 2019–May 30, 2020: From the CDC:
The National Syndromic Surveillance Program (NSSP) collects electronic health data in real time…
NSSP found that emergency department (ED) visits declined 42% during the early COVID-19 pandemic, from a mean of 2.1 million per week (March 31–April 27, 2019) to 1.2 million (March 29–April 25, 2020), with the steepest decreases in persons aged ≤14 years, females, and the Northeast. The proportion of infectious disease–related visits was four times higher during the early pandemic period.”

About health insurance

CMS Innovation Center Models COVID-19 Related Adjustments: In response to the COVID-19 pandemic, CMS is making changes to payment models, including bundled payments and ACOs. This chart is a great summary of the payment and quality assessment changes.

Today's News and Commentary

About healthcare devices

Lumendi reports its first 'incisionless appendectomy' procedure: “Lumendi’s disposable DiLumen system attaches to a traditional, standard endoscope and helps stabilize the device’s movements and the surrounding organ, allowing the procedure to be performed completely within the intestine.”

About pharma

Hydroxychloroquine, a drug promoted by Trump, failed to prevent healthy people from getting covid-19 in trial:”The study is the first randomized clinical trial that tested the antimalarial drug as a preventive measure, according to researchers at the University of Minnesota Medical School who conducted the trial. It showed that hydroxychloroquine, which has been touted by President Trump, was no more effective than a placebo — in this case, a vitamin — in protecting people exposed to covid-19.”

Effect of low‐dose aspirin on health outcomes: An umbrella review of systematic reviews and meta‐analyses: Here is the latest on the controversy of using low dose aspirin as primary prevention for cardiovascular disease (CVD). The benefit is a balance between preventing CVD events (like heart attack and stroke) and causing serious bleeding: “…the benefits and risks of low‐dose aspirin for the primary prevention of CVD events in the modern era of preventive management in middle‐aged people (i.e., involving statins, anti‐hypertension medications, smoking cessation, obesity management and other similar interventions) are closely balanced, calling into question the use of aspirin in those without a prior cardiovascular disease event.”

About the public’s health

Ultra-high-throughput clinical proteomics reveals classifiers of COVID-19 infection: This diagnostic process could help focus on patients who might require the most care.
“We use our platform on samples collected from a cohort of early hospitalized cases of the SARS-CoV-2 pandemic and identify 27 potential biomarkers that are differentially expressed depending on the WHO severity grade of COVID-19. They include complement factors, the coagulation system, inflammation modulators, and pro-inflammatory upstream and downstream of interleukin 6. All protocols and software for implementing our approach are freely available. In total, our platform supports the development of routine proteomic assays to aid clinical decision making and generate hypotheses about potential COVID-19 therapeutic targets.”

Fauci says he's 'cautiously optimistic' about Moderna COVID-19 vaccine: “Infectious disease expert Anthony Fauci, M.D., says he's "cautiously optimistic" about biotech company Moderna's COVID-19 vaccine candidate.
But he believes a successful COVID-19 vaccine will not be a ‘one and done’ and will require a booster dose to provide immunity.”

China delayed releasing coronavirus info, frustrating WHO: “Chinese government labs only released the genome after another lab published it ahead of authorities on a virologist website on Jan. 11. Even then, China stalled for at least two weeks more on providing WHO with detailed data on patients and cases, according to recordings of internal meetings held by the U.N. health agency through January — all at a time when the outbreak arguably might have been dramatically slowed.
WHO officials were lauding China in public because they wanted to coax more information out of the government, the recordings obtained by the AP suggest. Privately, they complained in meetings the week of Jan. 6 that China was not sharing enough data to assess how effectively the virus spread between people or what risk it posed to the rest of the world, costing valuable time.”

Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis:“Our search identified 172 observational studies across 16 countries and six continents, with no randomised controlled trials and 44 relevant comparative studies in health-care and non-health-care settings… Transmission of viruses was lower with physical distancing of 1 m or more, compared with a distance of less than 1 m… ; protection was increased as distance was lengthened…Face mask use could result in a large reduction in risk of infection… with stronger associations with N95 or similar respirators compared with disposable surgical masks or similar (eg, reusable 12–16-layer cotton masks…)”

Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions: These draft recommendations from the USPTF are now open for comment. One industry-influencing recommendation: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (e-cigarettes) for tobacco cessation in adults, including pregnant persons.”

Coronavirus fact check: Does the ‘recycled’ air on planes really put you at a high risk of infection?: This article is a really good summary of air quality issues on planes- better than you thought but not as good as you would like it to be.

About health insurance

Which Types of Insurance are Marketplace Enrollees Choosing?: Key findings from this Urban Institute study:
“Health plans issued by Blue Cross Blue Shield companies accounted for nearly half (47%) of the Affordable Care Act marketplace enrollment in 2018, but Medicaid health plans are emerging as competition.

• Blue Cross Blue Shield-affiliated insurers hold all or close to all of the enrollment in 11 states’ marketplaces (Alaska, Alabama, Delaware, Illinois, Louisiana, North Carolina, North Dakota, New Hampshire, Oklahoma, South Carolina, Wyoming).

• In another nine states (Arkansas, Florida, Hawaii, Kansas, Michigan, New Jersey, Pennsylvania, Tennessee, West Virginia), Blue Cross Blue Shield plans have the majority of enrollment, though they face increasing competition from other insurer types, typically Medicaid insurers.”

DHHS Office of the Inspector General Semiannual Report to Congress October 1, 2019-March 31, 2020: “During this semiannual reporting period (October 1, 2019, through March 31, 2020), we issued 81 audit reports and 14 evaluation reports. Our audit work identified $605.2 million in expected recoveries, as well as $288.4 million in questioned costs (costs questioned by OIG because of an alleged violation, costs not supported by adequate documentation, or the expenditure of funds where the intended purpose is unnecessary or unreasonable). Our audit work also identified $911.3 million in potential savings for HHS— funds that could be saved if HHS implemented all of OIG’s audit recommendations. “

Why COVID-19 is spurring 'buzz' among employers about reference-based pricing: The interesting facts from this article are that: “…employers spent an average of 241% of Medicare for care in 2017, paying 204% higher than Medicare rates for inpatient care and 293% higher for outpatient care.” In my experience, these rates are much higher than PPO rates, which are often no higher than 150% of Medicare rates. Why have Third Party Administrators for these plans allowed providers to get away with charging so much when they pay far less for their own insured products? 

About the business of healthcare

5 of healthcare's next billion-dollar startups from 2020 Forbes list: Here is a list of these 5 healthcare companies from the Forbes list. It is a real mix of products and services.

About hospitals/health facilities

Physicians acquire 35-hospital health system from private equity firm: “Dallas-based Steward Health Care is now the largest physician-owned healthcare system in the U.S.

Humana Launches Medicare Clinic Expansion In Three Cities: “Humana’s Partners in Primary Care unit will open 20 new senior-focused primary care centers over the next year in the new markets of Las Vegas and Louisiana plus a major expansion in Houston.
It’s the first wave of a three-year expansion of the geographic footprint for Humana’s Partners in Primary Care since the health insurer and private equity giant Welsh, Carson, Anderson & Stowe earlier this year announced a $600 million joint venture to develop primary care centers to treat seniors insured by Medicare Advantage plans.The 35-hospital system announced June 2 that a management group of Steward physicians led by the company's CEO and founder acquired a controlling interest of Steward from Cerberus Capital Management, a private equity firm. The physicians will control 90 percent of the company and Medical Properties Trust will maintain its 10 percent stake.”

Today's news and Commentary

About health insurance

Medicare Advantage, Part D plans face uncertain healthcare world under COVID-19 as they develop bids: Part D plan bids are due today and the media is focusing on the uncertainty of costs due to COVID-19. However, I have not seen any evidence that outpatient prescription drug use is increased or costs are higher during the pandemic. The real incremental costs seem to be for inpatient care, paid by
Part A under the DRG scheme.

Insurers Continue to Waive Customer Costs for Virus Tests, Care: “Health insurance companies are extending practices that ensure beneficiaries can receive free Covid-19 testing and treatment during the pandemic.
At least five insurers, including Aetna and Cigna, have decided to lengthen the period for which they would waive out-of-pocket costs related to the coronavirus past the initial June 1 end date, according to America’s Health Insurance Plans, an industry trade group.”

Trends in Insulin Out-of-Pocket Costs and Reimbursement Price Among US Patients With Private Health Insurance, 2006-2017: Health policy makers have said insulin costs are becoming unaffordable for most diabetics taking the medication. In response, CMS has placed a limit on out of pocket payments for Part D plans. But according to this study: “Although the findings in this study contradict the view that insulin cost-sharing is excessive for many privately insured patients, monthly out-of-pocket payments may be burdensome for low-income individuals. Nevertheless, the data suggest that privately insured patients have been relatively shielded from insulin price increases and that commercial health insurers have accommodated higher insulin prices by increasing premiums or deductibles for all members.”

More states moving to operate their own health exchanges: Uninsured rising: “Among the states transitioning to or considering creating their own marketplaces are Maine, New Jersey, New Mexico, Oregon and Pennsylvania.”

Out-Of-Network Spending Mostly Declined In Privately Insured Populations With A Few Notable Exceptions From 2008 To 2016: The bottom line of this research is that patients are increasingly using in-network physicians when they have a choice. The real problem is “surprise” billing for emergencies or when patients go to contracted facilities but employed physicians are not contracted.

The Potential Health Care Costs And Resource Use Associated With COVID-19 In The United States: “A single symptomatic COVID-19 case could incur a median direct medical cost of $3,045 during the course of the infection alone… If 20 percent of the US population were to get infected, there could be a median of 11.2 million hospitalizations, 2.7 million ICU admissions, 1.6 million patients requiring a ventilator, 62.3 million hospital bed days, and $163.4 billion in direct medical costs over the course of the pandemic.”

About the public’s health

Quest Diagnostics' self-collection COVID-19 test kit gets FDA nod for emergency use: “Quest Diagnostics received emergency use authorization for its self-collection COVID-19 test kit from the FDA.
The company intends more than a half-million test kits to be available by end of June, with plans to make additional kits available on an ongoing basis…The test kit was designed for self-collection by individuals, at home, with a consumer-friendly nasal swab approach, the company said.” But how good is the self-collection process?

Coronavirus may never go away, even with a vaccine: As COVID-19 becomes “endemic,” this article discusses what we should be doing to be able to live with it. As Tom Frieden, former director of the Centers for Disease Control and Prevention said: .”The one thing we have to do is to understand that there is not one thing. We need a comprehensive battle strategy, meticulously implemented.”

Concern About COVID-19 at Medical Facilities Drops: From Gallup: “As the national COVID-19 curve has flattened in the U.S., fewer Americans are concerned about being exposed to the virus while receiving necessary medical treatment. Although 64% of Americans are very (22%) or moderately (42%) concerned, this marks a 20-percentage-point drop from late March/early April.”

Despite widespread economic toll, most Americans still favor controlling outbreak over restarting economy, Post-ABC poll finds: This latest poll has many opinions about Trump v. Biden. Question 18 asks: “What do you think is more important – (trying to control the spread of the coronavirus, even if it hurts the economy), or (trying to restart the economy, even if it hurts efforts to control the spread of the virus)? Do you feel that way strongly or somewhat?” 57% said they felt strongly or somewhat that they preferred to control the spread of COVID-19; 37% preferred to restart the economy.

About healthcare quality

Some Regular Surveys and Review Activities Resuming With Extra Safety Considerations in June: This link explains what The Joint Commission will be doing as it resumes accreditation activities this month.

About hospitals

Covenant breaches to rise amid coronavirus but for most, credit quality likely unaffected: From Moody’s: “Covenant violations will likely rise because hospitals' revenues have declined dramatically, by an average of 30%-40%, because of the suspension of elective procedures amid the coronavirus outbreak…A covenant violation, or technical default, means that a borrower has not met required financial covenants, including debt service coverage and days cash on hand, found in borrowing agreements such as Master Trust Indentures (MTIs) and bank agreements, often called Continuing Covenant Agreements. A technical default, which is not a payment default, would pose a risk to bondholders if investors or lenders elect to accelerate debt in the face of the default. “

About pharma

Lilly Begins World's First Study of a Potential COVID-19 Antibody Treatment in Humans:”This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19…
The first patients in the study were dosed at major medical centers in the U.S., including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.”

Hydroxychloroquine or Chloroquine for Treatment or Prophylaxis of COVID-19: A Living Systematic Review: “There were few controlled studies, and control for confounding was inadequate in observational studies…Evidence on the benefits and harms of using hydroxychloroquine or chloroquine to treat COVID-19 is very weak and conflicting.”

Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19: Gilead announced: “We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.”

About healthcare IT

Telehealth: A quarter-trillion-dollar post-COVID-19 reality?: “Pre-COVID-19, the total annual revenues of US telehealth players were an estimated $3 billion, with the largest vendors focused in the ‘virtual urgent care’ segment: helping consumers get on-demand instant telehealth visits with physicians (most likely, with a physician they have no relationship with). With the acceleration of consumer and provider adoption of telehealth and extension of telehealth beyond virtual urgent care, up to $250 billion of current US healthcare spend could potentially be virtualized.”

Today's News and Commentary

About the public’s health

The effect of state-level stay-at-home orders on COVID-19 infection rates: Yes, stay-at-home procedures work. New cases of COVID-19 decreased by 58 percent in states that implemented the recommendation.

How risky is it to…? An interesting read from Politico that “provides a snapshot of where Americans see the most danger — and where they’re most out of sync with experts.” Differences are also apparent between Democrats and Republicans.  

Some Countries Have Brought New Cases Down To Nearly Zero. How Did They Do It?: A good international survey of what successful countries did to curb COVID-19. Common elements were early identification of the problem, politically unified responses using prepared plans, and isolation procedures.

US cuts World Health Organization ties over virus response:”President Donald Trump said Friday that the U.S. will be terminating its relationship with the World Health Organization, saying it had failed to adequately respond to the coronavirus because China has “total control” over the global organization.
He said Chinese officials “‘gnored’ their reporting obligations to the WHO and pressured the WHO to mislead the world when the virus was first discovered.
He noted that the U.S. contributes about $450 million to the world body while China provides about $40 million.”

The Trump campaign is creating an alternate reality online about coronavirus | The Fact Checker: This youtube video (produced by the Washington Post fact checkers) details how the administration’s narrative changed the sequence of events in response to COVID-19.

Some Coronavirus Patients Test Positive For Weeks. Interpret Those Results With Caution: “RNA can… be present, and therefore, detected by PCR after a virus has broken down (i.e., become non-infectious) and released its genome into host cells or body fluids. From prior experience with other infectious diseases, we know that PCR tests can be positive for days or weeks after a patient has recovered from the illness and is no longer infectious.
As more testing is being performed for Covid-19, we are learning that some patients can test positive for weeks following their initial diagnosis.”

About health insurance

IRS sets 2021 limits for HSAs: The content is self-explanatory.

Pandemic upends state plans to expand health insurance: The high costs of COVID-19 responses have caused a number of states to halt or reconsider insurance expansion ,such as Medicaid eligibility/benefits/funding.

Association of State Medicaid Expansion With Hospital Community Benefit Spending:” In this study, Medicaid expansion was associated with a decrease in nonprofit hospitals’ burden of providing uncompensated care, but this financial relief was not redirected toward spending on other community benefits.”

About pharma

An open letter to Mehra et al and The Lancet: The letter was sent by a long list of international scientists who criticized the methodology of the hydroxychloroquine study that The Lancet recently published.

About healthcare IT

Where Microsoft is headed in healthcare: A brief discussion of MIcrosoft’s healthcare plans. For example: “The company reported 34 million healthcare interactions on Microsoft Teams during the pandemic and has co-developed healthcare-specific solutions with partners including the CDC, Allscripts, Humana, Renton, Wash.-based Providence, Walgreens Boots Alliance and Nuance.”

National Trends in the Safety Performance of Electronic Health Record Systems From 2009 to 2018: “These findings suggest that despite broad adoption and optimization of EHR systems in hospitals, wide variation in the safety performance of operational EHR systems remains across a large sample of hospitals and EHR vendors. Hospitals using some EHR vendors had significantly higher test scores. Overall, substantial safety risk persists in current hospital EHR systems.”

About diagnostics

FDA approves Eli Lilly’s Tauvid dye, its first for mapping Alzheimer’s tau tangles: “The FDA approved its first radioactive diagnostic dye designed to map out the characteristic tau protein tangles found in the brains of people with Alzheimer’s disease—information that previously required an autopsy.” The dye is used with PET scans. This technology could be a major breakthrough in diagnosis if patterns are shown to be unique to this disease.

FDA greenlights ICU AI for predicting fatal COVID-19 complications:”The FDA granted an emergency authorization to CLEW Medical’s remote data monitoring system to help predict and identify COVID-19 patients under intensive care who are most at risk for respiratory failure or insufficient blood flow.
The company’s CLEWICU artificial intelligence software ingests a large range of patient data by linking to electronic medical records, connected medical devices and vital sign monitors, with no need for additional data entry by ICU staff. 
In addition to alerting providers to a patient’s potentially deteriorating condition as a diagnostic aid, the system’s real-time risk classification model also predicts which patients may not require any interventions within an eight-hour period. “
Obviously this technology can be used for other diseases as well.