Today's News and Commentary

About health insurance

Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage: This proposed rule from the Departments of Labor, HHS and Treasury (IRS) will be issued for comment on Wednesday. If finalized, it would “amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of cost-sharing requirements without causing a loss of grandfather status.” Recall that when the ACA was passed, certain group health plans were grandfathered so they could keep the terms of coverage. If anything subsequently changed, plans would lose that exemption. These changes would allow the plans to retain their grandfathered status.

MultiPlan and Churchill Capital Corp III Reach Agreement to Combine: “Churchill Capital Corp III, a public investment vehicle, and MultiPlan, Inc., a market-leading, technology-enabled provider of end-to-end healthcare cost management solutions, announced today that they have entered into a definitive agreement to merge. The combined company will operate as MultiPlan and will be listed on the NYSE. The transaction implies an initial enterprise value for MultiPlan of approximately $11 billion or approximately 12.9x estimated 2021 Adjusted EBITDA. The transaction will bring to MultiPlan up to $3.7 billion of new equity or equity linked capital to substantially reduce its debt and fund new value-added services.”

Oak Street Health files to go public: “Oak Street is a tech-enabled, value-based care primary care company that specifically targets Medicare-eligible patients, particularly those in underserved communities..”

Judge vacates CMS rule forcing ACA insurers to bill separately for abortions: “A federal judge in Maryland has vacated the Trump administration's 2019 rule that would require Affordable Care Act (ACA) marketplace insurers to bill separately for abortions.
Judge Catherine Blake for the District Court for the District of Maryland ruled Friday that the restrictions were "arbitrary and capricious" and violates the ACA. The case was brought by Planned Parenthood and the American Civil Liberties Union.”

State of Medicare Advantage: Report July 2020: An excellent review of the current state of the Medicare Advantage program looking at cost, quality and access issues. The reason these plans are important is because:
”In June 2020, there were 24.2 million Medicare Advantage beneficiaries, and over 68 million people eligible for Medicare. While the total number of enrolled beneficiaries in Medicare in 2020 has not been released, based on CMS’s projections Medicare Advantage penetration will reach 40% of overall enrollment in 2020…
In 2020, 99% of Medicare beneficiaries have access to at least one Medicare Advantage plan, with on average, 39 plan choices per county.”

About the public’s health

White House takes aim at Fauci as he disagrees with Trump on virus: A good summary of the rift. The part that caught my eye was:
“In an interview on NBC's ‘Meet the Press’ Sunday, Adm. Brett Giroir, a member of the White House coronavirus task force, said there is ‘open discourse’ within the team.
‘I respect Dr. Fauci a lot, but Dr. Fauci is not 100% right and he also doesn't necessarily -- and he admits that -- have the whole national interest in mind. He looks at it from a very narrow public health point of view,[emphasis added]’ Giroir said.”
In the end, what other view matters?

Long delays in getting test results hobble coronavirus response: “The long testing turnaround times are making it impossible for the United States to replicate the central strategy used by other countries to effectively contain the virus — test, trace and isolate. Like catching any killer, speed is of the essence when it comes to the coronavirus.” The article is a current update on the problem we have had from the beginning of the pandemic.

New U.S. dietary guideline recommendations take aim at sugar for children and adults: “The committee, a group of 20 doctors, registered dietitians and public health experts, recommends reducing added sugars to 6 percent of daily calories, from 10 percent….
And for the first time, the committee made recommendations for children up to 2 years old, suggesting a ban on sugar-sweetened beverages. The experts argued that calories from sugar-sweetened beverages may displace those from nutritious foods and increase the risk of the child becoming overweight.”

About hospitals and health systems

UHS settles false claims allegations for $122M:”As part of the settlement, announced July 10, UHS and UHS of Delaware Inc. agreed to pay $117 million to resolve allegations that the hospitals and facilities knowingly submitted false claims to government insurers, including Medicaid, Medicare and Tricare. 
Prosecutors alleged that the company billed for inpatient behavioral health services that were not medically necessary or failed to provide adequate services for patients admitted to its facilities. The alleged billing scheme occurred between January 2006 and December 2018, prosecutors said.“

About pharma

Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system: From the FDA: “At this time, we are working toward the goal of restarting on-site inspections during the week of July 20. However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area. Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation. The availability of these services will be an important factor in how we determine resuming domestic inspections.”

About healthcare IT

Doximity Telehealth App Becomes One of the Most Used Telemedicine Tools in the U.S.:After you get through some self-promotion, there are a couple interesting findings of their research:

• “Physician adoption by age: Physicians in their 40’s and 50’s are using telemedicine more often than younger colleagues in their 30’s.

• Physician adoption by gender: A gender disparity was identified among physician users, showing female doctors adopting telemedicine at a much higher rate (25%) than their male colleagues.”

4 AI systems outperforming medical experts: Interesting summary of four AI technologies.

Today's News and Commentary

About health insurance

Comparing Private Payer and Medicare Payment Rates for Select Inpatient Hospital Services: Among the findings of this Kaiser Family Foundation study: “Private insurance payment rates were between 1.6 and 2.5 times higher than Medicare rates, with some variation among the ten DRGs included in our analysis…Private insurance paid at least $10,000 more than Medicare rates on average for four of the seven other diagnoses we analyzed.” A perfect example of cost-shifting.

Exchanges May Add More than 1 Million New Enrollees due to COVID-19:The latest projections from Avalere.

Accountable Care Organizations and Patient-Centered Medical Homes: Health Expenditures and Health Services: Researchers compared “total health expenditures and health services utilization of patients receiving care in stand-alone accountable care organization (ACO only), stand-alone patient-centered medical home (PCMH only), hybrid (ACO + PCMH), and standard (neither ACO nor PCMH) facilities.” The study concluded that care “received in ACO and PCMH facilities is associated with lower total health care costs compared with standard care. However, hybrid models are associated with slightly higher total health care costs compared with stand-alone models. Integrating innovations in health care delivery and health care reimbursement warrants further evaluation.” The last sentence is noteworthy- higher costs are perhaps due to lack of coordination in the hybrid model.

About the public’s health

The next two articles have a common theme- making healthcare information understandable

How to Read Covid-19 Research (and Actually Understand It): A really good explanation of this topic with examples like hydroxychloroquine effectiveness evaluations. When you finished with this article, read: U.K. megatrial outshines other drug studies.

Americans Are Bewildered by Patchwork of Social-Distancing Rules: “A growing number of public health experts agree that there needs to be more nuanced guidelines for Americans that allow some liberties. Public-health non-profit Vital Strategies has suggested color-coded alerts that communicate to the public how severe the virus is in a given region so that people can adjust their activities appropriately on any given day. (Vital Strategies has received funding from Bloomberg Philanthropies, the charitable foundation of Michael Bloomberg, the founder and majority owner of Bloomberg News’s parent company.) The Texas Medical Association has an activity guide citing camping, tennis and take-out as low-risk, while movie theaters and gyms are high.”

Preschooler's Month of Birth Influences Odds of Becoming Ill With the Flu: “Preschoolers have a higher risk of being diagnosed with the flu if they are born before September, an analysis of insurance claims from more than 1.1 million children has concluded.
The reason: children with birthdays in July and August are less likely to receive the annual influenza vaccine when they are 2 to 5 years old because they often have their annual checkup close to their birthday, before the seasonal vaccine is available.”

Want to defeat COVID-19? Deliver a 70% effective vaccine—and get 70% of people to take it, FDA official says: “To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.
That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.”

Oxford researchers develop portable COVID-19 test costing less than $25:”The University of Oxford and its research center in China are launching a new company to develop a rapid COVID-19 test that could cost no more than £20, or about $25 U.S.”

Independent evaluation of global COVID-19 response announced: Amid criticisms over its slow response, the WHO Director-General “announced the initiation of the Independent Panel for Pandemic Preparedness and Response (IPPR) to evaluate the world’s response to the COVID-19 pandemic.”

New WHO guidance calls for more evidence on airborne transmission: “The World Health Organization on Thursday released new guidelines on the transmission of the novel coronavirus that acknowledge some reports of airborne transmission of the virus that causes COVID-19, but stopped short of confirming that the virus spreads through the air…
The report follows an open letter from scientists who specialize in the spread of disease in the air - so-called aerobiologists - that urged the global body to update its guidance on how the respiratory disease spreads to include aerosol transmission.”

About healthcare IT

Telemedicine is booming during the pandemic. But it’s leaving people behind.:”Unless health-care systems commit to deploying video technology that is explicitly designed to provide care for our most vulnerable patients, telehealth will further entrench health disparities.” The article provides examples of care disparities created by usual telehealth systems.

Most physicians predict fewer than 10% of their visits will be virtual by next year :The article provides some details of projected telemedicine use by specialty.

Doctor on Demand lands $75M to invest in virtual primary care, behavioral health: “Doctor On Demand wasn't planning to raise capital this year, but the company has seen demand for virtual visits surge during the COVID-19 pandemic.
The venture-backed telemedicine company raised $75 million in series D financing led by General Atlantic, a global growth equity firm, with participation from existing investors.”
See the above story about projected lower use of telemedicine.

Teladoc sued due to robocalls: “April Hale and Len Cline filed suit on July 8 in the Southern District of New York after receiving multiple unsolicited robocalls, attempting to sell its $29.99 membership package. Teladoc contracted with Health Insurance Innovations to place the calls, which the defendants claim violates the Telephone Consumer Protection Act. Both companies would share in the profit from sales, according to the lawsuit.”

The tradeoffs between safety and alert fatigue: Data from a national evaluation of hospital medication-related clinical decision support: “Although hospitals improved overall from 2017 to 2018, there is still important room for improvement for both fatal and nuisance orders. Hospitals that incorrectly alerted on one or more nuisance orders had slightly higher overall performance, suggesting that some hospitals may be achieving higher scores at the cost of overalerting, which has the potential to cause clinician burnout and even worsen safety.”

A new AI tool to fight the coronavirus: “Members of the newly formed Collective and Augmented Intelligence Against COVID-19 (CAIAC) announced today include the Future Society, a non-profit think tank from the Harvard Kennedy School of Government, as well as the Stanford Institute for Human-Centered Artificial Intelligence and representatives from UN agencies. 
Within six to eight weeks, CAIAC's platform will produce a decision-making tool that will initially focus on digital contact tracing of coronavirus infections, ferreting out misinformation about the pandemic and identifying second and third-order effects of COVID-19 that go beyond illness and death.”

About pharma

Drug Giants Create Fund to Bolster Struggling Antibiotic Start-Ups: “Twenty of the world’s largest pharmaceutical companies on Thursday announced the creation of a $1 billion fund to buoy financially strapped biotech start-ups that are developing new antibiotics to treat the mounting number of drug-resistant infections responsible for hundreds of thousands of deaths each year.
The fund, created in partnership with the World Health Organization and financed by drug behemoths that include Roche, Merck, and Johnson & Johnson, will offer a short-term but desperately needed lifeline for some of the three dozen small antibiotic companies, many of them based in the United States, that have been struggling to draw investment amid a collapsing antibiotics industry.”

Trump will sign three executive orders on lowering drug prices: chief of staff: “President Donald Trump will sign three executive orders on lowering prescription drug prices, White House Chief of Staff Mark Meadows said on Thursday.” No details were given.

FDA Approves Mylan and Fujifilm’s Humira Biosimilar: Further competition will lower prices for this often-used specialty medication.

About hospitals

Tenet hospital agrees to $72.3M settlement with DOJ over kickback suit: “The Department of Justice (DOJ) announced this week that the Oklahoma Center for Orthopaedic and Multi-Specialty Surgery (OCOM)—as well as its part-owner management company, which includes USP OKC and USP OKC Manager (USPI), Southwest Orthopaedic Specialists (SOS) and two SOS physicians—agreed to the settlement to resolve of false claims. Tenet owns 95% of USPI.
The DOJ alleged improper relationships between OCOM and SOS resulted in the submission of false claims to the Medicare, Medicaid and TRICARE programs.”

Today's News and Commentary

About pharma

A flawed Covid-19 study gets the White House’s attention — and the FDA may pay the price: This article explains critiques of the recently reported Henry Ford system study that claimed benefit for hydroxychloroquine use earlier in hospitalized patients. “Not only was it not randomized, outside experts noted, but patients who received hydroxychloroquine were also more likely to get steroids, which appear to help very sick patients with Covid-19. That is likely to have influenced the central finding of the Henry Ford study: that death rates were 50% lower among patients in hospitals treated with hydroxychloroquine.” Experts fear that the President will mandate retesting of the drug even though all other major studies have failed to prove a benefit.

Walgreens swings to a quarterly loss as coronavirus drives up costs, lowers doctor visits; shares fall: “Walgreens said its profits were squeezed by a shift in sales to low-margin items, increased supply-chain costs and higher expenses for labor and store cleaning.”

Live Updates: July 2020 Drug Price Increases: The 42 drugs that have price increases in July “add to the 857 brand and generic drugs that already increased in price by an average of 6.8% from January 1 to June 30, 2020.”  The article has a list of the medications.

CVS Pharmacy introduces new app feature for reading “talking” prescription labels: “By the end of 2020, 1,500 CVS Pharmacy locations will be equipped to affix special RFID labels to prescription vials. When the RFID labels are scanned by Spoken Rx in the CVS Pharmacy app, which can be accessed by users using Siri or Google Assistant on their phones, prescription label information will be spoken out loud.”

Becton Dickinson Gets $42 Million HHS Contract for Injection Device: “HHS’ Biomedical Advanced Research and Development Authority (BARDA) has granted Becton Dickinson a $42 million contract to manufacture hundreds of millions of syringes and needles for delivery of COVID-19 vaccines.”

About the public’s health

Best Hospital Cities Ranking 2019: This study ranks cities by the infrastructure, quality and accessibility of their hospitals. Included is an international list…#1 is Tokyo. The only US city in the international top 20 is Boston.

ACS Updates HPV Vaccination Recommendations to Start at Age 9: The latest American Cancer Society recommendation for HPV vaccination.

About health insurance

Walmart launching insurance agency in Dallas with focus on Medicare: Another case of cross functional diversification: “Job listings show the company has quietly formed Walmart Insurance Service, LLC., focusing initially in the Dallas-Fort Worth market. The listings indicate that the initial focus will be on selling Medicare plans, though it's unclear if that means Medicare Advantage plans, Medicare supplemental plans or both.”

Medicare Beneficiaries’ Race and Ethnicity Data Inaccurate: “Significant inaccuracies exist in Medicare beneficiaries’ race and ethnicity data, which could exacerbate disparities in healthcare access and quality, according to a study published in Medical Care.
Administrative data, including insurance plan enrollment and demographic information, are contained in the Medicare Beneficiary Summary File (MBSF), the team stated. In contrast to administrative data sources, national surveys of Medicare beneficiaries include self-reported race and ethnicity…
 ‘The inaccuracy of state-level data on Medicare beneficiaries’ race and ethnicity is staggering,’ said Irina Grafova, assistant professor at Rutgers School of Public Health.
‘We found that, in 19 states, about 20 percent of Hispanic Medicare beneficiaries were misclassified as belonging to another ethnic group. In 24 states, more than 80 percent of American and Alaskan Native beneficiaries of Medicare were misclassified. And in the majority of states, at least one-fourth of Asian American and Pacific Islander beneficiaries were misclassified.’”
Authors suggest self-reporting is far more accurate than assigned race; the latter was done in the Medicare home-care setting.

About healthcare IT

VA inks 10-year, $100M deal with Philips for remote critical care services:”The Department of Veterans Affairs (VA) has inked a $100 million contract with Philips to extend its remote intensive care capabilities.
As part of the 10-year contract, the VA will work with Philips to enhance telehealth technology and services including tele-ICU, diagnostic imaging, sleep solutions and patient monitoring to improve care for veterans.”

About healthcare quality

COVID19 Impact & Mitigation Strategies for Payer Quality Improvement 2021: This AHIP-commissioned study found that because of delayed preventive care and reduced ambulatory visits, COVID19 will have a negative impact on 74 percent of the NCQA HEDIS quality measures. By far, the highest impact is on behavioral health.

Today's News and Commentary

About health insurance

Supreme Court sides with Trump administration on rules to create more exemptions to ACA birth control mandate: “The Supreme Court ruled Wednesday that the U.S. Department of Health and Human Services has the ability to create a religious and moral exemption to the Affordable Care Act’s birth control mandate.”

98% of physicians avoid MIPS penalties: 5 things to know: CMS released results of the 2018 MIPS performance, which determines 2020 payments. Among the results:
” Most clinicians in MIPS — 98 percent — avoided a negative payment adjustment in 2018. A year earlier, 5 percent of clinicians received a negative payment adjustment.
Most clinicians — 84 percent — earned an "exceptional performance" designation, resulting in positive payment adjustments ranging from 0.2 percent to 1.68 percent.”

California surgeon charged in $600M billing fraud scheme: “Randy Rosen, MD, his girlfriend and four others were allegedly involved in a fraud scheme that involved hiring body brokers to pay patients at sober living homes to undergo medically unnecessary surgeries. He is also accused of requiring patients to undergo unnecessary drug tests which he sent to a laboratory owned by his girlfriend.”

 About pharma

Startup PBM Capital Rx, Walmart partner to shed light on specialty, mail-order drug prices: Walmart is teaming up with a pharmacy benefits manager (PBM) . The alleged reason is increased transparency but it is obvious Walmart wants to get into the pharmacy benefits business to service payers or corporations that are self-insured.

Walgreens Boots Alliance invests $1B in VillageMD to open 500+ medical clinics, expand telehealth: 6 details: “Clinics will accept several health insurance options and offer telehealth 24/7 as well as at-home visits. VillageMD and Walgreens already made telehealth available to providers on Walgreens Find Care, an online platform that connects patients with virtual services.”

Sandoz to supply Civica Rx with 6 injectable drugs: Civica Rx is expanding its source for pharmaceuticals.

About healthcare IT

Digital behavioral health startups scored $588M in funding amid COVID-19 pandemic: “Digital health is on pace to have its largest funding year ever thanks to the rising demand for virtual care and disease monitoring.
U.S. digital health companies raised $5.4 billion in venture funding across the first six months of 2020. The first half of 2020 saw more funding than any previous first half of the year from 2011 to 2019 and beat the prior record of $4.2 billion set in the first half of 2019…”

VA panel proposes $1.1B more for $16B Cerner EHR upgrade: “The House Military Construction, Veterans Affairs and Related Agencies Appropriations Subcommittee proposed a $104.8 billion discretionary budget for the VA, according to the July 6 report. The budget proposal is $12.3 billion more than the fiscal year 2020 budget and would approve $4.9 billion for IT modernization, up 12 percent from last year's budget.”

About the public’s health

Fauci favors mandatory mask orders:”Fauci, director of the National Institute of Allergy and Diseases, says the United States is in a resurgence of new coronavirus cases, with daily cases nearly double the country’s previously high baseline. Infection rates have been rising in the South and West…’What is alarming is the slope of the curve,’ Fauci said of cases in Alabama. He added, ‘the signal should be wear a mask, period.’”

Health panel may open lung cancer screening to more smokers: In a draft statement, the US Preventive Task Force said “it’s time to expand screening to those who’ve smoked less -- 20 pack-years -- and to start a little sooner, at age 50. The proposed change comes after a newer study found those people are about as likely to benefit as the heavier, older smokers.
If finalized, the new recommendations would make about 15 million Americans eligible for screening, nearly double today’s number…
Importantly, more women and African Americans would qualify…”

.Trump to launch short-term 'surge' COVID-19 testing in hot spot cities:”The Trump administration is launching new "surge" coronavirus testing sites in some of the hardest-hit communities in Florida, Texas and Louisiana.
The Department of Health and Human Services (HHS) said the free COVID-19 testing sites will be located in Jacksonville, Fla., Baton Rouge, La., and Edinburg, Texas, beginning Tuesday. 
The surge will last between five and 12 days, and the sites will be able to conduct 5,000 tests per day in each city. It should take between three and five days for someone who is tested to get their results.”

Study: ‘Silent’ Transmission the Top Driver of COVID Outbreaks:”Just over half of new coronavirus infections are tied to people who don't have symptoms, according to a new study from infectious disease modelers.
People sick with COVID-19 can be infectious before they start to show symptoms, while some don't show symptoms at all. The study, published this week in the scientific journal Proceedings of the National Academy of Sciences, estimates that these presymptomatic and asymptomatic cases account for 48% and 3.4% of virus transmissions, respectively – meaning ‘silent disease transmission’ can fuel outbreaks even if everyone who has symptoms is immediately isolated.”

UN chief reviewing whether US has met conditions for WHO withdrawal: “The official withdrawal would take effect on July 6, 2021, due to a one-year notification period required by WHO’s constitution.” However, will will have to see if the President ignores this requirement.

Protective gear for medical workers begins to run low again:The headline speaks for itself.

Volunteers can now sign up for large coronavirus vaccine studies: “The Covid-19 Prevention Trials Network, which knits together the existing federal clinical trial infrastructure developed largely to test HIV vaccines and treatments, launched with a website for volunteers to sign up to be considered when the first trials begin later this month.”

Association of Exposure to Court-Ordered Tobacco Industry Antismoking Advertisements With Intentions and Attempts to Quit Smoking Among US Adults: “Industry-sponsored antismoking advertisements were associated with increased intentions to quit smoking; however, they have not been effective in stimulating attempts to quit among current smokers.”

Association of a Public Health Campaign About Coronavirus Disease 2019 Promoted by News Media and a Social Influencer With Self-reported Personal Hygiene and Physical Distancing in the Netherlands: The researchers “leveraged the power of social norms by having an influencer and a newspaper model appropriate behavior to their audiences. By exposing individuals from the target group to our public health campaign through personalized messaging about their gaps in behavior, we aimed to bridge their intention-behavior gap, which usually results in greater behavioral change.” They found that this campaign “was associated with an approximately 2-fold increase in the odds of washing of all required hand areas and longer duration of handwashing.” Applicability to the US needs to be determined, but it is still an interesting approach.

About hospitals

Introducing the Best Hospitals for America: Here is a different ranking methodology and list hospitals, based on “institutions that save lives, save money, and serve social justice.” In a related article: US News updates hospital ranking methodology: 5 things to know.

Industry Voices—Hospitals will face a new labor shortage after the pandemic: Before the COVID-19 pandemic, there were shortages of many professionals staffing hospitals. With an anticipated rebound in service volume caused by pent-up demand, the shortages may look even worse.

Hospital Merger and Acquisition Activity Withstands COVID-19 Slum: The headline speaks for itself.

Hospital Concentration Index: Interesting analysis by the Healthcare Cost Institute that looked for concentration as a causet of healthcare cost increases. “While metro areas varied in their levels of concentration, by 2017, the majority of metros would be categorized as highly concentrated markets. This reflects the fact that most metros became increasingly concentrated over time.”

Today's News and Commentary

About the public’s health

Trump administration begins formal withdrawal from World Health Organization: “The Trump administration has notified Congress and the United Nations that the United States is formally withdrawing  from the World Health Organization, multiple officials tell CNN, a move that comes amid a rising number of coronavirus cases throughout the Americas in the last week alone.” See, also: Letter to Congress on WHO Withdrawal from Public Health, Law and International Relations Leaders.

BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing: “BD clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity…” A related article: A New Generation of Fast Coronavirus Tests Is Coming.

Comparing SARS-CoV-2 with SARS-CoV and influenza pandemics: An excellent, comprehensive article that should be required epidemiology course reading. “The objective of this Personal View is to compare transmissibility, hospitalisation, and mortality rates for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with those of other epidemic coronaviruses, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), and pandemic influenza viruses.”

FDA warns about 5 additional toxic hand sanitizers: “Consumers should avoid five additional brands of hand sanitizer that tested positive for methanol, a substance that can be toxic when absorbed through the skin or ingested, the Food and Drug Administration said. The warning comes after the agency last month cautioned against any of nine brands of possibly toxic hand sanitizer that may contain methanol.”

More Mask Use, Worry About Lack of Social Distancing in U.S.: Some people are finally “getting it.'‘ This latest Gallup poll found:

• “54% worried about lack of social distancing in local area, up from May

• 86% of U.S. adults have used a mask in public in past week [This and the above finding are new highs]

• Democrats [98%] much more likely than Republicans [66%] to worry and wear masks”

Life-saving HIV drugs risk running out as COVID-19 hits supplies: WHO: “More than a third of the world’s countries say they are at risk of running out of life-saving AIDS drugs because of disruptions to supply lines and other problems caused by the COVID-19 pandemic, the World Health Organization said on Monday.
Twenty-four out of those 73 nations have already reported critically low supplies of the vital antiretroviral drugs, the agency said.”

About health insurance

CMS proposes Medicare payment updates to increase use of home dialysis: “The Centers for Medicare & Medicaid Services (CMS) issued an add-on payment last year to offer higher reimbursement for eligible home dialysis machines. In a rule proposed Monday, the agency said it would enhance that payment further, allowing for coverage for additional new and innovative home dialysis machines.”

Today's News and Commentary

About health insurance

What COVID means for voluntary benefits might surprise you: The leader of Willis Towers Watson’s voluntary benefits practice, Mark Hebert, “has seen ‘tremendous'‘ growth in voluntary benefits in the last several years.” Such benefits include hospital indemnity, critical illness and accident/injury insurance, pet insurance, identity theft insurance, and legal insurance. “Research from Willis Towers Watson shows that 12% of employers surveyed by the consulting firm have enhanced voluntary benefits in the wake of COVID. Just 1% say they’ve reduced voluntary plans, although the vast majority haven’t made any changes.”

About the public’s health

239 Experts With One Big Claim: The Coronavirus Is Airborne: “…in an open letter to the W.H.O., 239 scientists in 32 countries have outlined the evidence showing that smaller particles can infect people, and are calling for the agency to revise its recommendations. The researchers plan to publish their letter in a scientific journal next week.”

Zoonoses: beyond the human–animal–environment interface: “World Zoonoses Day on July 6 marks the day, in 1885, when a young boy received the first vaccine against rabies—a zoonosis, a disease caused by a pathogen transmitted from animals to humans.”

6 COVID-19 Social Determinants of Health Payers Pivoted to Meet: Interesting article that outlines how payers are addressing issues ranging from housing to food to employment.

To prep for a complicated flu season, FDA greenlights CDC’s combined influenza & COVID-19 test: “The FDA issued a new emergency authorization to the Centers for Disease Control and Prevention for a combination influenza and COVID-19 diagnostic test—as the U.S. prepares to enter its annual flu season later this year in the midst of a global pandemic.
The test is designed to help tell the difference between patients with one of the two diseases, who may present with similar respiratory symptoms. It’s the third diagnostic authorized by the FDA for this purpose, following panels from Qiagen and BioFire Diagnostics, which also cover additional viruses.”

Trial of Moderna Covid-19 vaccine delayed, investigators say, but July start still possible: “Moderna did not respond to multiple emails asking about how long the delay will last, the nature of the protocol changes, or whether they have anything to do with the vaccine’s safety or manufacturing.” This vaccine was supposed to be the soonest to market.

Rush to reopen led to spikes in cases that threaten to overwhelm hospitals in some states, officials say: “‘We’re right back where we were at the peak of the epidemic during the New York outbreak,’ former Food and Drug Administration commissioner Scott Gottlieb said on ‘Face the Nation’ on CBS. ‘The difference now is that we really had one epicenter of spread when New York was going through its hardship, now we really have four major epicenters of spread: Los Angeles, cities in Texas, cities in Florida, and Arizona. And Florida looks to be in the worst shape.’”

About healthcare IT

Telehealth can be life-saving amid COVID-19, yet as virus rages, insurance companies look to scale back: The headline tells the story. The article has many examples of this cutback.

About healthcare quality

Hospital ratings often depend more on nice rooms than on health care: Nice summary of the fact that patients’ assessment of the technical quality of care and appreciation for the amenities do not jibe.

About pharma

Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19: This study from Henry Ford Health System showed that “use of hydroxychloroquine alone and in combination with azithromycin was associated with a significant reduction in-hospital mortality compared to not receiving hydroxychloroquine.” The result is contrasted with the lack of benefit in a large NY study because that latter “study included patients who were initiated on hydroxychloroquine therapy at any time during their hospitalization. In contrast, in [the Henry Ford] patient population, 82% received hydroxychloroquine within the first 24 hours of admission, and 91% within 48 hours of admission. Because treatment regimens [in the NY study] likely varied substantially (including delayed initiation) across the 25 hospitals that contributed patients to the study, it is not surprising that the case-fatality rate among the New York patients was significantly higher than in our study.” It was a bit unusual that none of this study’s patients had a common hearth rhythm disturbance common in other studies. The authors caution that their “results should be interpreted with some caution and should not be applied to patients treated outside of hospital settings. Our results also require further confirmation in prospective, randomized controlled trials that rigorously evaluate the safety, and efficacy of hydroxychloroquine therapy for COVID-19 in hospitalized patients.”

About healthcare technology

StartUp Health’s 2020 Midyear Funding Report Shows a Robust, Diversified Health Innovation Market: Despite (or perhaps because of) the COVID-19 pandemic, “total health innovation funding for the first half of 2020 hit $9.1B, up nearly 19% compared to the same period in 2019…
At 377 deals, 2020’s midyear deal totals exceeded 2019…” The article also lists the top deals so far this year; a diversified list from different health sectors.

Today's News and Commentary

About the public’s health

Fever checks are a flawed way to flag Covid-19 cases. Experts say smell tests might help: “‘My impression is that anosmia is an earlier symptom of Covid-19 relative to fever, and some infected people can have anosmia and nothing else,’ said physician Andrew Badley, who heads a virus lab at the Mayo Clinic. ‘So it’s potentially a more sensitive screen for asymptomatic patients.’
In a recent study, Badley and colleagues found that Covid-19 patients were 27 times more likely than others to have lost their sense of smell. But they were only 2.6 times more likely to have fever or chills, suggesting that anosmia produces a clearer signal and may therefore be a better Covid-catching net than fever.”

Characteristics of Adult Outpatients and Inpatients with COVID-19 — 11 Academic Medical Centers, United States, March–May 2020: “In a multistate telephone survey of 350 adult inpatients and outpatients who tested positive for SARS-CoV-2 infection, only 46% reported recent contact with a COVID-19 patient. Most participants’ contacts were a family member (45%) or a work colleague (34%). Two thirds of participants were employed; only 17% were able to telework.” In other words, 54% of infected persons did not know where they got the disease.

Healthcare added 358K jobs in June with hospitals adding jobs after dip in May: “Healthcare employment continued to recover from the COVID-19 pandemic in June with 358,000 jobs added to the industry and hospital jobs started to increase, according to the latest federal jobs report. The report released Thursday represents a slight increase from the 315,000 jobs the industry added in May. It showed that hiring in physician and dentist offices continues to recover, and hospitals added 6,000 jobs after declining by 26,000 in May.”

Discrimination and Hypertension Risk Among African Americans in the Jackson Heart Study: An interesting and timely study on the Social Determinants of Disease: “Higher stress from lifetime discrimination was associated with higher hypertension risk after adjustment for demographics (hazard ratio for high versus low, 1.19 [95% CI, 1.01–1.40]), but the association was attenuated after adjustment for hypertension risk factors (hazard ratio, 1.14 [95% CI, 0.97–1.35]). Lifetime discrimination may increase the risk of hypertension in African Americans.”

Trump says he's 'all for masks' despite reluctance to wear one: “‘I’m all for masks. I think masks are good,’ Trump told Fox Business in an interview, adding that he would wear a face covering if he were in a ‘tight situation’ with other people.
Trump noted that he hasn’t had to wear a mask because people who come in contact with him are tested for the coronavirus. Asked whether he would wear a mask publicly, Trump said he would have ‘no problem’ with doing so.”

Estimation of Excess Deaths Associated With the COVID-19 Pandemic in the United States, March to May 2020:”In this cohort study, the number of deaths due to any cause increased by approximately 122 000 from March 1 to May 30, 2020, which is 28% higher than the reported number of COVID-19 deaths…
Official tallies of deaths due to COVID-19 underestimate the full increase in deaths associated with the pandemic in many states.”

COVID-19 strain in Beijing outbreak may have come from Southeast Asia: Harvard study:”The outbreak in Beijing has raised concerns about China’s vulnerability to a ‘second wave’ of infections. The virus found in Beijing cases is an imported strain of COVID-19, according to the China Centre for Disease Control and Prevention.” The three genome samples “showed the greatest resemblance to cases in Europe from February to May, and to cases in South and Southeast Asia from May to June.”

About health insurance

The COVID-19 Pandemic: Insurer Insights into Challenges, Implications, and Lessons Learned: Among the findings from these Urban Institute interviews of insurance executives:

• “Insurers appear well-positioned financially to navigate the COVID-19 crisis, at least for now.

• While insurers expect the economic downturn to have a significant impact on their employer business, to date, most insurers report that their employer block of business remains surprising stable. Still, there are concerns that small employers, in particular, will begin to drop coverage in the coming months.

• Medicaid enrollment is on the rise, but expected increases in individual market enrollment have yet to materialize in a significant way.

• Most insurers are concerned that the financial impact of COVID-19 on some medical practices will lead to further consolidation among providers.

• Though insurers face a significant degree of uncertainty, they believe the crisis will have less of an impact on 2021 premiums than initially feared.

• Most insurers feel that the COVID-19 crisis has not prompted a need to change benefit designs to any great degree, though they believe telehealth benefits are here to stay.

• Insurers acknowledge that further changes to the health care system are needed to address health disparities, especially racial and ethnic disparities.”

Today's News and Commentary

About the public’s health

Humana to offer home COVID-19 testing, drive-thru testing at Walmart: “Humana will now offer LabCorp’s home COVID-19 tests to its members and is teaming up with Walmart and Quest Diagnostics to provide access to drive-thru tests.
Members enrolled in the insurer’s Medicare Advantage, Medicare supplement, Medicaid and employer group plans are eligible for either type of test, and out-of-pocket costs will continue to be waived.”

Labs warn of test result delays amid coronavirus surges:”Commercial and clinical labs are warning that there may be extended turnaround times for COVID-19 test results amid an uptick in demand for testing as cases rise across the U.S.
Quest Diagnostics said June 29 that the average turnaround time for nonpriority patients' test results will be three to five days due to the increase in demand. It used to be a one-day turnaround. 
The commercial lab said it will still be a one-day turnaround for priority patients.”

Just 50% of Americans plan to get a COVID-19 vaccine. Here’s how to win over the rest: A must-read article that has an update of different market segments’ opinions on their likelihood of getting a COVID-19 vaccine. It also analyzes the objections. The main obstacle is concern over safety. In this case the fear of loss (or harm) is more powerful than the allure of upside gain (in this case prevention of serious illness). So the campaign for vaccination needs to address that main concern. For example, expert opinion may not be as persuasive as celebrity endorsements.

A Dire Warning From COVID-19 Test Providers:”The American testing supply chain is stretched to the limit, and the ongoing outbreak in the South and West could overwhelm it, according to epidemiologists and testing-company executives. While the country’s laboratories have added tremendous capacity in the past few months—the U.S. now tests about 550,000 people each day, a fivefold increase from early April—demand for viral tests is again outpacing supply.”

Suppression of a SARS-CoV-2 outbreak in the Italian municipality of Vo’: The important take-away: “Notably, 42.5% (95% CI 31.5-54.6%) of the confirmed SARS-CoV-2 infections detected across the two surveys were asymptomatic (i.e. did not have symptoms at the time of swab testing and did not develop symptoms afterwards).”

Hollowed-Out Public Health System Faces More Cuts Amid Virus: At a time when public health is crucial, we face a neglected and shrinking resource. “Since 2010, spending for state public health departments has dropped by 16% per capita and spending for local health departments has fallen by 18%, according to a KHN and Associated Press analysis of government spending on public health. At least 38,000 state and local public health jobs have disappeared since the 2008 recession, leaving a skeletal workforce for what was once viewed as one of the world’s top public health systems.”

HHS extends partnership with retailers to boost COVID-19 testing:”The U.S. Department of Health and Human Services said on Tuesday it would extend its partnership with private pharmacies and grocery chains to provide better access to COVID-19 testing. 
The partnership with CVS Health Corp, Rite Aid Corp, Walgreens boots Alliance Inc, Kroger and Walmart Inc has been scaled up to more than 600 COVID-19 testing sites across the country. 
About 70% of the testing sites under the program are located in areas that have moderate-to-high vulnerability to the virus.”

As Coronavirus Surges, How Much Testing Does Your State Need To Subdue The Virus?: While the testing volume is very different across the country, we need to be doing 4.3 million tests per day for COVID-19 suppression and 1.2 million tests per day for “mitigation.” We are only doing close to 600,000 per day.

The radical technologies to keep offices clear of coronavirus: Interesting technology explanations ranging from self-cleaning surfaces to ventilation changes.

About health insurance

Oklahoma voters approve Medicaid expansion as coronavirus cases climb: The significance of the story is this Red State’s decision at the same time the Republicans are pushing for the ACA’s repeal and the prospect that Oklahoma was to be the first state to try a block grant system for Medicaid.

10 indicted in $1.4B rural hospital fraudulent billing scheme: DOJ: “The Department of Justice (DOJ) has indicted 10 people, including a Miami-based hospital executive, in connection with a pass-through billing scheme that used rural hospitals as shells to submit fraudulent bills for lab tests.
Between November 2015 and February 2018, private plans were billed for $1.4 billion in tests and paid out $400 million, according to the DOJ. The indictment was unsealed Monday.”

Society of Actuaries tool allows payers to model COVID costs: “For example, researchers at SOA estimate that for each month that there is a high level of social distancing, annual insured healthcare costs decrease by 4%.”

About emerging science

Malaria's secret to surviving in the blood uncovered: This discovery provides a new method to attack malaria.
“When the malaria parasite enters a red blood cell it digests haemoglobin, leading to the release of a compound called haem, which is toxic to the parasite if it is left loose inside the cell. 
The researchers found that to overcome this, the parasite uses a protein, called PV5, to control a process where free haem molecules are joined together into insoluble crystals which are not harmful. This is vital to the survival of the malaria parasite.
When the researchers blocked this protein in the lab, they found that the human-infecting malaria parasite  made fewer and highly misshapen crystals. When the protein was blocked in mice that had been infected with a rodent strain of malaria, the parasite became more sensitive to several antimalarial drugs.”

Re­search­ers have found a prom­ising ther­apy for car­diac re­gen­er­a­tion:”The tissue-engineered approach relies on a local transplantation of minute pieces of autologous atrial appendage tissue, termed atrial appendage micrografts (AAMs), to the surface of the ischaemically stressed myocardium…
’We demonstrated not only preservation of heart's pumping function following critical ischemic insult but also improved functional recovery following AAMs transplantation during follow-up,’ says Docent Maciej Lalowski from University of Helsinki.”

About hospitals and health systems

Hospitals and Health Systems Continue to Face Unprecedented Financial Challenges due to COVID-19: The AHA updates projected losses from COVID-19 (emphases in the original):
“Hospitals and health systems currently report average declines of 19.5% in inpatient volume and 34.5% in outpatient volume relative to baseline levels.
The AHA estimates an additional $120.5 billion in total financial losses from July 2020 through December 2020 should hospitals and health systems reach baseline patient volumes by July 2021, or an average of $20.1 billion per month. These estimates are in addition to the $202.6 billion in losses the AHA estimated between March 2020 and June 2020 bringing the total projected losses to hospitals and health systems in 2020 to at least $323.1 billion.”

Mayo Clinic And Tech Firm Launch ‘Hospital Care At Home’ Venture: This article is in this section because of the substitution of inpatient services at home. “The Mayo Clinic and the technology company Medically Home are partnering to launch a new healthcare delivery model that will deliver ‘advanced care’ typically available inside a hospital into patient homes.”

About healthcare IT

UCSF pays hackers $1.1M to regain access to medical school servers: These problem are still very much with us.

Where Telemedicine Falls Short: An HBR article by Dr. David Blumenthal, president of the Commonwealth Fund and former National Coordinator for Health IT.  The essence of his message: “I also know that well-trained clinicians use all their senses — not just hearing and vision. They appraise the whole patient: Is there a new limp, a shift in posture, a new pallor? Often, it’s what patients don’t notice or complain about that is essential. And there is no diagnostic test more cost-effective than the laying on of hands. I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?”

About pharma

US buys up world stock of key Covid-19 drug remdesivir: This article is the “other side” of the previous report on our federal government buying up the remdesivir supply for the next few months.
”The US has bought up virtually all the stocks for the next three months of one of the two drugs proven to work against Covid-19, leaving none for the UK, Europe or most of the rest of the world.
Experts and campaigners are alarmed both by the US unilateral action on remdesivir and the wider implications, for instance in the event of a vaccine becoming available. The Trump administration has already shown that it is prepared to outbid and outmanoeuvre all other countries to secure the medical supplies it needs for the US.”

Walgreens testing smaller store format: 8 things to know:The headline is the story. For example: “In the small stores, there are fewer items for sale in the front of the store and fewer over-the-counter medications. They are about a quarter of the size of a typical Walgreens store, which sits at 13,500 square feet.”

Today's News and Commentary

About pharma

FDA Outlines Its Conditions for Approving a Covid-19 Vaccine: “The Food and Drug Administration released guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.
The FDA said that no vaccine would be approved unless a vaccine company had ‘clearly demonstrated’ proof of a vaccine’s safety and effectiveness through a clinical study, according to the guidance.
The FDA also said a vaccine wouldn’t be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.” The 50% seems low but is in line with acceptable effectiveness of flu vaccines.

Big Pharma Hikes Drug Prices in the Midst of COVID-19 Crisis: “ According to a new analysis by Patients For Affordable Drugs, drug companies raised the list prices of 245 drugs by an average of 23.8 percent since the first case of the novel coronavirus in the U.S. was reported in January. The research found that 75 percent of those price hikes were drugs directly linked to COVID-19 treatment or conditions that place people at higher risk of the virus.”

CVS Health reportedly launching a GPO called Zinc: “While very few details about the plan were revealed, Zinc is expected to be similar to Ascent Health Services, a Switzerland-based GPO that Express Scripts launched in 2019, according to the report.
Ascent helps conduct rebate negotiations for Express Scripts. Prime Therapeutics also has relied on Ascent for rebate negotiations, according to the report.”

Houston pharmacist dubbed 'Compound King' gets 10-year prison sentence in $21M fraud case: “According to court documents, Tompkins and his co-conspirators billed the Department of Labor for about $21.8 million in compounded gels and creams that were not medically necessary and were predicated on kickbacks. The scheme specifically targeted injured state and federal employees, according to the DOJ.” Again, note that it was governmental units that were defrauded not private entities.

Biopharma tackles COVID-19, HIV and other viruses with gene and cell therapies: Interesting summary of how these therapies are being developed to treat COVID-19.

Pharma giants to unveil major $1 billion venture to push novel antibiotics:”Amid escalating concerns over antibiotic resistance, several big drug makers are creating a new $1 billion for-profit venture to acquire or invest in small antibiotic companies and their nascent products, according to two people familiar with the plans.
The effort will be announced on July 9 by the chief executive officers at Pfizer, Merck, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Bayer Pharmaceuticals, and Merck KGaA, among others. Also on hand will be government officials from Germany, Sweden, the U.K., and France, as well as representatives from Wellcome Trust and Pew Charitable Trusts.”

About hospitals and health systems

IBM Watson Health Recognizes Top-Performing U.S. Hospitals and Health Systems: “IBM Watson Health® today announced its 2020 Fortune/IBM Watson Health 100 Top Hospitals list and 15 Top Health Systems award winners, naming the top-performing hospitals and health systems in the U.S. Extrapolating the results of this year's studies, if all Medicare hospitalized patients received the same level of care as those treated in the award-winning facilities, more than 100,000 additional lives and billions of dollars in inpatient costs could be saved. The lists of the top hospitals and health systems were published by Fortune.”

About health insurance

House fires back at Trump by passing ObamaCare expansion: “The legislation, which passed in a largely party-line vote of 234 to 179, would increase the 2010 health law’s subsidies that help people afford their premiums and add more federal funding for Medicaid expansion.
Democrats timed the vote to contrast with the Trump administration’s legal brief filed with the Supreme Court last week calling for the ACA to be struck down, a move Democrats said would be even more harmful during the coronavirus pandemic.” Obviously no chance for passage in the Republican-controlled Senate.

About the public’s health

Flu virus with 'pandemic potential' found in China: “The new flu strain that has been identified in China is similar to 2009 swine flu, but with some new changes…Current flu vaccines do not appear to protect against it, although they could be adapted to do so if needed.”

CDC says U.S. has ‘way too much virus’ to control pandemic as cases surge across country: “The coronavirus is spreading too rapidly and too broadly for the U.S. to bring it under control, Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, said Monday.
The U.S. has set records for daily new infections in recent days as outbreaks surge mostly across the South and West. The recent spike in new cases has outpaced daily infections in April when the virus rocked Washington state and the northeast, and when public officials thought the outbreak was hitting its peak in the U.S.”

Fauci testifies new coronavirus cases could 'go up to 100,000 a day if this does not turn around’: “‘“We are now having 40-plus thousand new cases a day. I would not be surprised if we go up to 100,000 a day if this does not turn around. And so I am very concerned,’ Fauci said in response to questioning from Sen. Elizabeth Warren (D-Mass.) on what the overall U.S. death toll is likely to be.” The article also has a summary of updates on the pandemic, including the growing Republican acknowledgement of the need to wear masks.

HHS will renew public health emergency: “HHS spokesperson Michael Caputo on Monday tweeted that HHS intends to extend the COVID-19 public health emergency that is set to expire on July 25.
The extension would prolong the emergency designation by 90 days. Several payment policies and regulatory adjustments are attached to the public health emergency, so the extension is welcome news for healthcare providers.”

Today's News and Commentary

About healthcare professionals

The Complexities of Physician Supply and Demand: Projections From 2018 to 2033: This pre-COVID-19 survey is the latest estimates of the title’s topic and worth a read. The bottom line is:

• A primary care physician shortage of between 21,400 and 55,200 is projected by 2033.

• A shortage of non-primary care specialty physicians of between 33,700 and 86,700 is projected by 2033.

About the public’s health

Supreme Court Hands Abortion-Rights A Victory In Louisiana Case:”A sharply divided U.S. Supreme Court on Monday stood by its most recent abortion precedent. Chief Justice John Roberts joined the court's four liberals, citing the Supreme Court's adherence to precedent, to invalidate a Louisiana law that required doctors at clinics that perform abortions to have admitting privileges at a nearby hospital. 
Louisiana's law is virtually identical to one struck down by the court in 2016, which found that the admitting privileges law in Texas was medically unnecessary and that it significantly limited access to abortion.”

How the World Missed COVID-19’s Silent Spread:Excellent article in the NY Times with many examples : “The two-month delay was a product of faulty scientific assumptions, academic rivalries and, perhaps most important, a reluctance to accept that containing the virus would take drastic measures. The resistance to emerging evidence was one part of the world’s sluggish response to the virus.”

Some US states return to previous restrictions to slow surges of coronavirus cases: A good summary of the headline’s topic.

How the Coronavirus Short-Circuits the Immune System: This well-written article explains the current knowledge of what happens to the immune system in COVID-19 infection.

This coronavirus mutation has taken over the world. Scientists are trying to understand why.: In January, SARS-CoV-2 infections “bore the same genetic signatures as a germ that emerged in China weeks before.” But as the virus spread, it has mutated “in the part of the genome that codes for the all-important ‘spike protein’ — the protruding structure that gives the coronavirus its crownlike profile and allows it to enter human cells the way a burglar picks a lock.”

 America’s Shifting Covid-19 Epidemic in Five Charts: A really good graphic representation of current pandemic trends. National trend are being driven by a few states where rates are rising. Overall cases are in an upward trend that should surpass the previous peak.

Japanese startup creates 'connected' face mask for coronavirus new normal: For your interest, or amusement. Wonder how good it is at containing infection.

About health insurance

CPT code approved for SARS-CoV-2 antigen testing: This AMA article is a good example of how codes are added with emerging diseases and technology.

About pharma

Gilead's long-awaited remdesivir price is $3,120, in line with watchdog estimates: “For private insurance plans, Gilead set a list price of $520 per vial, Gilead CEO Daniel O’Day revealed Monday. The cost for a five-day treatment course using six vials, which most patients are expected to receive, would add up to $3,120. For governments of developed countries, including the U.S., the price will be lower, at $390 per vial or $2,340 per course.”

HHS secures 500K courses of remdesivir for distribution to hospitals: “The amount secured represents 100% of drugmaker Gilead's projected production for July (94,200 courses), 90% of production projected for August (174,900 courses) and 90% of production projected for September (232,800 course).”

Pfizer sues for U.S. permission to assist patients needing expensive heart drugs: “The drugmaker said the U.S. Department of Health and Human Services’ Office of Inspector General is blocking it from offering financial aid to patients unable to afford copayments for its Vyndaqel and Vyndamax drugs, because it views such aid as an illegal kickback.” The drugs can cost $225,000 per year.
The issue is that drug company payments for out of pocket expenses have allowed them to raise prices to payers for the remainder of the bill.

Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries: ““Among 61 238 US adults taking prescription medications… the estimated prevalence of purchasing of medication outside the US was 1.5%... Those who purchased medications outside the US were more likely to be older (age >64 years…), to be from Hispanic…or immigrant populations, and to have higher educational attainment (bachelor's degree…), lower family income…, and lack of insurance…  Data analyses indicated that online health information–seeking behavior… or use of an online pharmacy… was associated with a greater likelihood of medication purchases outside the US. Individuals who skipped medications…or delayed filling a prescription… (also had higher odds of purchasing medication outside the US.” It is estimated that more than 2 million Americans buy their drugs from sources abroad.

AstraZeneca, Moderna ahead in COVID-19 vaccine race: WHO: The headline speaks for itself and provides an update on vaccine progress against SARS-CoV-2.

About healthcare IT

CMS issues its first proposal to continue telehealth flexibilities, in home health proposed rule: “CMS has issued a proposed rule to make permanent regulatory changes to telecommunications technologies in providing care under the Medicare home health benefit beyond the expiration of the public health emergency for the COVID-19 pandemic.”

About emerging technology

Using laser-welded sugar, Rice bioengineers build 3D vessel networks for lab-grown tissues: The headline speaks for itself. Fascinating!

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.