Today's News and Commentary

About healthcare quality

Apology Law Is Constitutional, Ariz. Appeals Court Finds: “An Arizona appeals court has ruled that a state law that a health care worker's apology can't be used as evidence of malpractice is constitutional in an appeal by a couple who said their obstetrician's conduct led to one of their twins suffering brain damage.” One of the basic tenets of “modern” quality processes is an apology for errors. But lawyers are often reluctant to allow their clients to make such statements. The affirmation of the constitutionality of this law can provide an impetus for other states to enact similar legislation.

About hospitals and health systems

Providence posts $94M loss in first half as higher staff expenses offset increases in volume: This article highlights two important points: Personnel-related costs are the single biggest institutional expense (in fact, the majority) and relying to a great degree on temp staff is not a financially stable policy.

About health insurance

Humana completes acquisition of Kindred at Home: “With the deal finished, Humana is now the country's largest provider of home healthcare services. Kindred at Home provides home health, hospice and personal care to more than 550,000 patients each year, Humana said.” This deal continues the trend of insurers buying provider organizations.

About Covid-19

Biden says US will require nursing homes get staff vaccinated or lose federal funds: “Biden said he is directing the Department of Health and Human Services to draw up new regulations making employee vaccination a condition for nursing homes to participate in Medicare and Medicaid.”
Many healthcare employers have been reluctant to require vaccines because, facing a tight labor market, they are afraid workers will quit. This action may force their hands. The question is what other leverage does the federal government have? Certainly, hospitals and other health facilities can be likewise compelled to vaccinate employees; but what about other institutions that receive federal monies- like public schools and universities that get research funding?

Third dose of Pfizer, BioNTech's COVID-19 vaccine 86% effective in over-60s: study: “According to initial results released by a large Israeli health maintenance organisation (HMO), a third dose of Pfizer and BioNTech's COVID-19 vaccine BNT162b2 was 86% effective in people aged over 60.”

Early Convalescent Plasma for High-Risk Outpatients with Covid-19: “Outcomes regarding worst illness severity and hospital-free days were similar in the two groups [antibody and placebo]…
The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression.”

Vaccines still effective against Delta variant of concern, says Oxford-led study of the COVID-19 Infections Survey: “Obtaining two vaccine doses remains the most effective way to ensure protection against the COVID-19 Delta variant of concern dominant in the UK today, according to a study from the University of Oxford…
Two doses of either vaccine still provided at least the same level of protection as having had COVID-19 before through natural infection; people who had been vaccinated after already being infected with COVID-19 had even more protection than vaccinated individuals who had not had COVID-19 before.
However, Delta infections after two vaccine doses had similar peak levels of virus to those in unvaccinated people; with the Alpha variant, peak virus levels in those infected post-vaccination were much lower.”

About healthcare IT

CDC Stands Up New Disease Forecasting Center: “The center, with initial funding from the American Rescue Plan, will focus on three key functions:

• Predict: Undertake modeling and forecasting; enhance the ability to determine the foundational data sources needed; support research and innovation in outbreak analytics and science for real-time action; and establish appropriate forecasting horizons.

• Connect: Expand broad capability for data sharing and integration; maximize interoperability with data standards and utilize open-source software and application programming interface capabilities, with existing and new data streams from the public health ecosystem and beyond.

• Inform: Translate and communicate forecasts; connect with key decision-makers across sectors including government, businesses, and non-profits, along with individuals with strong intergovernmental affairs and communication capacity for action.”

Biden-Harris Administration Invests over $19 Million to Expand Telehealth Nationwide and Improve Health in Rural, Other Underserved Communities: The “Biden-Harris Administration is announcing key investments that will strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. These investments—totaling over $19 million—are being distributed to 36 award recipients through the Health Resources and Services Administration (HRSA) at the U.S. Department of Health and Human Services (HHS).”

HCA Healthcare to Sell PatientKeeper to Venture Firm General Catalyst’s Commure and Enter Into a New Strategic Collaboration: “HCA Healthcare…and General Catalyst, a global venture capital firm, today announced the sale of HCA Healthcare’s PatientKeeper to General Catalyst’s portfolio company Commure along with an investment in Commure and the formation of a new strategic collaboration to accelerate digital transformation.
PatientKeeper is a leading provider of intuitive software and mobile applications that help physicians and care teams access and work with patient information….
HCA Healthcare will continue to deploy PatientKeeper technology at its more than 180 hospitals across the country. For more than a decade, physicians at HCA Healthcare-affiliated hospitals have been using PatientKeeper to access a single view of their patients’ information across a variety of hospital systems, to streamline workflow, and to help improve patient care.”

About pharma

NICE changes to provide faster, fairer access to new drugs and devices: England’s National Institute for Health and Care Excellence (NICE) announced changes in its evaluation process to authorize new therapies. Since the organization is a model for rational technology evaluation, the announcement is worth reading.

Verily makes its first major acquisition as it looks to transform clinical trials: “On the heels of a series of prominent recent hires, Verily announced plans on Tuesday to make its first major acquisition by buying SignalPath, a North Carolina company which developed a clinical trial management platform. Verily, an Alphabet spinout founded in 2015, plans to use the acquisition to increase its appeal to clinical trial sites and to speed its efforts on decentralized research…”

About the public’s health

U.S. appeals court upholds Texas ban on second-trimester abortion procedure: “The 5th U.S. Circuit Court of Appeals upheld on Wednesday a Texas law effectively banning the most common abortion procedure for terminating second-trimester pregnancies, reversing a ruling last year by a three-judge panel of the same court.
Wednesday's decision marks the first time a U.S. federal court has upheld a prohibition on the standard abortion method used after 15 weeks of pregnancy - dilation and evacuation, or D&E - though some other states have acted to outlaw it…
Physicians found to have violated the measure would face a prison term of up to two years.
Nine judges on the New Orleans-based appeals court joined in ruling in favor of the Texas statute, with five judges dissenting and three recused from the case.
The newly re-instated law forbids D&E abortions unless the physician first performs a separate, additional procedure in the woman's body to bring about the demise of the fetus.”

About health technology

Microengineered perfusable 3D-bioprinted glioblastoma model for in vivo mimicry of tumor microenvironment: This 3-D printed tumor has the supporting structures and blood vessels if in-situ cancers. The authors conclude: “Our 3D-bioprinted model could be the basis for potentially replacing cell cultures and animal models as a powerful platform for rapid, reproducible, and robust target discovery; personalized therapy screening; and drug development.”

Today's News and Commentary

About Covid-19

U.S. reports more than 1,000 COVID deaths in single day: ”The United States reported more than 1,000 COVID-19 deaths on Tuesday, equating to around 42 fatalities an hour, according to a Reuters tally, as the Delta variant continues to ravage parts of the country with low vaccination rates.
Coronavirus-related deaths have spiked in the United States over the past month and are averaging 769 per day, the highest since mid-April, according to the Reuters tally.”

Biden administration to start offering vaccine booster shots to all Americans Sept. 20: “The plan, which applies only to the Pfizer and Moderna vaccines, calls for all Americans to get a booster shot eight months after receiving their second doses. The officials said they expect a booster shot will be needed for people who received the Johnson & Johnson vaccine, but they are still reviewing data and will announce plans at a later date.”

Most Americans support requiring masks in public places, yet few report experiencing actual employer or government mandates: “Two-thirds (64%) support their state or local government requiring masks to be worn in all public places.
However, there are significant partisan differences, with the vast majority of Democrats (88%) and less than half of Republicans (40%) in favor of state or local mask mandates.
Support for state and local mask requirements also varies based on where people live, with those living in urban areas (71%) being more supportive than those who live in rural areas (49%).
Despite this strong support for mask requirements, only a third (33%) say that their state or local government has required masks to be worn in all public places in the last few weeks.”

Texas Gov. Greg Abbott, who has sought to ban mask mandates in schools, tests positive for the coronavirus: He was vaccinated and is apparently asymptomatic. The positive test was part of regular screening. The problem is he does not wear a mask when in large groups.

What’s safe to do during summer’s Covid surge? STAT asked public health experts about their own plans: Interesting responses about their own preferences. The one unanimous reply was that: “None of 27 people who answered this question expressed a willingness to send an unvaccinated child to school without a mask.” The bar graph is a quick look at responses.

Vaccines show declining effectiveness against infection overall but strong protection against hospitalization amid delta variant: “Three studies published Wednesday by the Centers for Disease Control and Prevention show that protection against the coronavirus from vaccines declined in the midsummer months when the more contagious delta variant rose to dominance in the United States.
At the same time, protection against hospitalization was strong for weeks after vaccination, indicating the shots will generate immune fighters that stave off the worst effects of the virus and its current variations.”

UK authorises Moderna's COVID-19 vaccine Spikevax for adolescents: “The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday extended the conditional authorisation for Moderna's mRNA COVID-19 vaccine Spikevax, allowing it to be given to 12- to 17-year-olds in Great Britain.”

About pharma

Walgreens Launches Industry-First myWalgreens Credit Card Program – The Credit Card That Pays Well to Stay Well®: The card offers customers discounts and cash rewards on purchases at Walgreens stores. Wonder why the company did not take this action sooner.

FDA new drug applications to cost more than $3M in 2022: “Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.
The FDA's fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.
The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.”

About health insurance

Association of Race and Ethnicity and Medicare Program Type With Ambulatory Care Access and Quality Measures: “Medicare Advantage, compared with traditional Medicare, was significantly associated with better outcomes for ambulatory care access and quality among minority beneficiaries, but minority beneficiaries nonetheless experienced worse outcomes for most of these measures compared with other beneficiaries within both Medicare programs.”

Higher and Faster Growing Spending Per Medicare Advantage Enrollee Adds to Medicare's Solvency and Affordability Challenges: “Medicare spending for Medicare Advantage enrollees was $321 higher per person in 2019 than if enrollees had instead been covered by traditional Medicare. The Medicare Advantage spending amount includes the cost of extra benefits, funded by rebates, not available to traditional Medicare beneficiaries.
The higher Medicare spending per Medicare Advantage enrollee, compared to spending for similar beneficiaries under traditional Medicare, contributed an estimated $7 billion in additional spending in 2019.
Growth in Medicare Advantage enrollment explains half of the projected increase in total Medicare Advantage spending between 2021 and 2029 and half is attributable to growth in Medicare payments per Medicare Advantage enrollee, after accounting for inflation.”

Evaluation of Clinical and Economic Outcomes Following Implementation of a Medicare Pay-for-Performance Program for Surgical Procedures: “The findings of this study suggest that the pay-for-performance program was associated with improvement on several dimensions of surgical care, including small reductions in surgical site infection and length of stay, and moderate reductions in hospital costs.”

Today's News and Commentary

About Covid-19

Biden administration to announce most Americans will need coronavirus booster shots: “Administration officials believe people should get additional shots eight months after being fully vaccinated…
Administration of boosters would not occur until mid- or late September, after an application from Pfizer-BioNTech for the additional shots is cleared by the Food and Drug Administration, the individuals said.” In a related article: COVID-19 CPT coding and guidance, the AMA reviews coding for the vaccines, including Pfizer and Moderna third shots. Further: Pfizer, BioNTech submit early data to FDA to support COVID-19 vaccine booster: “Pfizer and partner BioNTech announced Monday that they have submitted Phase I data to the FDA supporting the use of a third dose of their COVID-19 vaccine BNT162b2. The companies stated that these findings will also be submitted to the European Medicines Agency and other regulatory bodies in the coming weeks.” And finally: A million Israelis get third dose, with early data showing heightened protection: “According to health ministry figures, the results are very promising. Third-dose recipients appear to be 2.5 times more protected from infection than those who received two doses of the Pfizer vaccine. The added protection appears to reach its peak about a week after the third dose is given.
Amid rising cases, last month Israel became the first nation in the world to begin administering booster shots to those 60 and over. On Friday, Israel began giving third doses to people ages 50 and up.”

UPDATE ON ACTEMRA®(TOCILIZUMAB) SUPPLY IN THE U.S.: From Roche: “The dramatic emergence of the COVID-19 Delta variant, as well as the unexpected slowing of vaccination rates in the U.S., has led to an overwhelmingly high incidence of COVID-19 hospitalizations in certain areas of the country. This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase…
[Despite efforts to increase the supply,] we are experiencing a temporary stockout of Actemra IV in the U.S. for 200mg and 400mg SKUs, as of Monday, August 16th, and have notified our customers. We currently have a short supply of the 80mg SKU, and we anticipate stockout by the end of the week. 
We expect the next scheduled replenishments to arrive by the end of August. However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

Man shot 6 times waits more than a week for surgery after hospital is overwhelmed by covid:
A great ethics case. The shooting victim was an innocent bystander. The Covid patients at Ben Taub Hospital in Houston (where the ICU is at 103 % of capacity) could have prevented their disease if they were vaccinated. Who “deserves” the beds more?

Association of Vaccine Type and Prior SARS-CoV-2 Infection With Symptoms and Antibody Measurements Following Vaccination Among Health Care Workers: “Clinically significant symptoms following dose 1 were associated with prior SARS-CoV-2 infection, confirming prior reports. Clinically significant symptoms following vaccination were more frequent following dose 2 and receipt of the Moderna vaccine.”

GSK and CureVac’s second Covid vaccine yields stronger response: “The second-generation Covid-19 vaccine from GlaxoSmithKline and its partner CureVac induces a stronger immune response than the German biotech’s first vaccine, according to a new study. In an animal study, which has yet to be peer reviewed, the companies said the mRNA vaccine could induce antibodies capable of tackling several variants of concern, including Beta, Delta and Lambda. The new vaccine elicited a response more quickly and created a higher level of antibodies than CureVac’s first-generation vaccine. It was also better at activating B and T cells, other important elements of the immune system’s response. In a phase 3 trial, CureVac’s first vaccine had an average efficacy of 48 per cent. The partners plan to start a phase 1 clinical trial on humans of the second-generation vaccine in the fourth quarter.”

Association of Age and Pediatric Household Transmission of SARS-CoV-2 Infection: “This study suggests that younger children may be more likely to transmit SARS-CoV-2 infection compared with older children, and the highest odds of transmission was observed for children aged 0 to 3 years.”

Covid Vaccines Produced in Africa Are Being Exported to Europe: “South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.
At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.”

About pharma

Merck joins other drugmakers in cutting off sales to 340B contract pharmacies: “Merck became the latest drugmaker to cut off sales of 340B-discounted products to contract pharmacies, despite warnings from the federal government that similar moves by other companies violate the program’s statute.
The drug giant wrote to 340B entities last week that if they do not join the company’s program integrity initiative then it will cut off sales to most contract pharmacies starting on Sept. 1.”

Blues plans pass on including aducanumab on formulary: A short summary of which plans are not going to cover the drug.

FDA Requests Feedback on Older Approved Generic Drugs: “The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics.
Dubbed PANDAs (Pre-Hatch-Waxman ANDAs) by the agency, the drugs were first approved even earlier, between 1938 and 1962, when the agency only required drugs to be proven safe rather than both safe and effective.”

About healthcare IT

Bias and fairness assessment of a natural language processing opioid misuse classifier: detection and mitigation of electronic health record data disadvantages across racial subgroups: “We identified bias in the false negative rate (FNR = 0.32) of the Black subgroup compared to the FNR (0.17) of the White subgroup. Top features included “heroin” and “substance abuse” across subgroups. Post-hoc recalibrations eliminated bias in FNR with minimal changes in other subgroup error metrics. The Black FNR subgroup had higher risk scores for readmission and mortality than the White FNR subgroup, and a higher mortality risk score than the Black true positive subgroup (P < .05).”
AI can lead to both under- and over diagnosis of conditions due to model biases. The authors caution that: “From model design through deployment, bias and data disadvantages should be systematically addressed.”

TELEHEALTH RESEARCH INCUBATOR: Research Snapshots: A really good analysis of the costs and efficiency of telehealth visits. The report lays out a series of questions and then answers them.
For example, telehealth visits, on average, are several minutes longer and cost slightly more than in-person visits. But throughput is higher with telemedicine (no surprise). Telehealth also leads to more followup visits than in-person care.

About the public’s health

Biden administration approves largest increase to food assistance benefits in SNAP program history: “Benefits will rise by 25 percent on average, an infusion of cash that advocates say better reflects the modern cost of a basic diet.”

First Tick-Borne Encephalitis Vax Approved in the U.S.— TicoVac has been available abroad for 45 years: “It has been a long road to U.S. approval for TicoVac, which the manufacturer noted has been approved outside the country since 1976 -- over 170 million doses have been administered since that time. TicoVac, also marketed in Europe under the name FSME-Immun, is an inactivated whole virus vaccine that mimics the tick-borne encephalitis found in nature, and induces neutralizing antibodies against the virus, Pfizer said.”

‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors: “‘We are definitely aware of patients who have refused blood products from vaccinated donors,’ said Dr. Julie Katz Karp, who directs the blood bank and transfusion medicine program at Thomas Jefferson University Hospitals in Philadelphia.
In practical terms, blood centers have only limited access to donated blood that has not in some way been affected by covid. Based on samples, Katz estimated that as much as 60% to 70% of the blood currently being donated is coming from vaccinated donors. Overall, more than 90% of current donors have either been infected with covid or vaccinated against it, said Dr. Michael Busch, director of the Vitalant Research Institute, who is monitoring antibody levels in samples from the U.S. blood supply.
’Less than 10% of the blood we collect does not have antibodies,’ Busch noted.”

About healthcare professionals

ASA Position Statement on AANA Name Change: The American Society of Anesthesiologists (ASA) is gravely concerned with the American Association of Nurse Anesthetists’ (AANA) adoption of the new name ‘American Association of Nurse Anesthesiology.’ Medical title misappropriation, including AANA’s name change and their blatant encouragement of their members to use the term ‘nurse anesthesiologist,’confuses patients and creates discord in the care setting, ultimately risking patient safety. 
The term ‘anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from non-physicians, including nurse anesthetists.”

About health insurance

More than half of medical practices report being forced to pay to receive electronic payments from insurers: From an MGMA poll:
”Of those who responded “yes” (57%) to being charged fees for EFT payments in the poll:

• 10% stated they were charged a fee of 1% of their total reimbursement

• 43% responded they were charged 2%

• 43% stated they were charged 3%

• 4% indicated they were charged 4% or more per EFT transaction…

The Association has called on CMS to repost prior industry guidance that was removed in 2017, or for CMS to clearly restate this guidance in a definitive manner. Additionally, MGMA believes if CMS will not provide clear guidance, the agency should clearly state why it is not using its authority to prohibit these abuses.”

Medicare Paid New Hospitals Three Times More for Their Capital Costs Than They Would Have Been Paid Under the Inpatient Prospective Payment System: From the HHS OIG: Medicare regulations require that established hospitals be paid for capital costs through the Inpatient Prospective Payment System (IPPS). These regulations also allow new hospitals to be exempt from the IPPS payment methodology for capital costs and, instead, to be paid for these costs on a cost reimbursement basis for their first 2 years of operation. The stated rationale for this IPPS exemption is that new hospitals may not have adequate Medicare utilization in those initial 2 years and may have incurred significant startup costs.
Our objective was to determine the potential cost savings to Medicare if the IPPS exemption were removed such that capital payments to new hospitals would be paid under the IPPS…
We identified significant potential cost savings to Medicare if the IPPS exemption were removed and capital payments to new hospitals were made through the IPPS. For the 112 new hospitals that we reviewed, Medicare paid a total of $283 million more for capital costs than it would have paid if these hospitals had been paid through the IPPS. The IPPS exemption resulted in new hospitals being paid three times more-or an average of almost $1.3 million more per cost report-under the reasonable cost methodology than if they had been paid for their capital costs under the IPPS…
We recommend that CMS review the findings in this report and, if it determines that a separate payment methodology for capital costs at new hospitals is no longer warranted, change its regulations to require new hospitals to have their Medicare capital costs paid through the IPPS with an option for payment adjustments or supplemental payments if necessary.”

Waste in the Medicare Program: a National Cross-Sectional Analysis of 2017 Low-Value Service Use and Spending: “We used Medicare claims and enrollment data for 100% of fee-for-service beneficiaries aged 65 and older continuously enrolled in parts A, B, and D for two years in 2017: 15,168,134 beneficiaries, requiring at least one and up to three years of claims history preceding the 2017 measurement year…
Among the included beneficiaries, 5,389,619 (35.5%) had at least one low-value service, accounting for 10 million distinct services... The three most frequent services were as follows: opioids for acute low back pain (2.8 million, 28.5%), preoperative baseline laboratory studies (2.6 million, 25.6%), and oral antibiotics for acute upper respiratory or external ear infections (1.4 million, 13.9%)—comprising over two-thirds of low-value services measured (68%).
Cumulative low-value service spending varied from $723 million ($48 per capita) at the claim-line-level to $2.1 billion ($140 per capita) at the claim-level... Spending per service varied from $6.32 for bleeding time testing at the claim-line-level to $7344.39 for renal artery revascularization at the claim-level..”
The total cost of all these unnecessary tests is ~$212.6 billion.

Health Disparities: This link is for an excellent special JAMA issue on this topic.

Today's News and Commentary

Here are 3 major policy areas that health industry groups are closely watching in $3.5T infrastructure bill: A good, concise review.

About Covid-19

Texas Supreme Court sides with governor and temporarily blocks mask mandates: The latest on a previously reported story:
”The Texas Supreme Court sided with Gov. Greg Abbott on Sunday in a ruling that temporarily blocks mask mandates recently issued in San Antonio and Dallas, though local officials said they will continue to enforce at least a portion of the mask mandates.
The Texas high court granted stay orders Sunday, but previously scheduled hearings on local mask mandates in lower courts in Bexar and Dallas counties will proceed as scheduled.”

Israel expands COVID vaccine booster campaign to over 50s, health workers: “Those eligible will be ‘people over 50, health care workers, people with severe risk factors for the coronavirus, prisoners and wardens,’ the health ministry said.
Israelis aged 60 and over started receiving the booster two weeks ago, ahead of any third-dose approval by the FDA. The US agency on Thursday authorised booster doses for people with compromised immune systems.” And in a related article: Biden administration plans for vaccine boosters, perhaps by fall

Does COVID cause babies to develop differently? - prelim data: “Children born during the coronavirus pandemic have significantly reduced verbal, motor and overall cognitive performance compared to children born before the pandemic, and this discrepancy is particularly pronounced in males, as well as in children in lower socioeconomic families, according to preliminary data presented in a preprint study. Researchers believe that this highlights that even in the absence of infection and illness, the pandemic has had a significant, negative impact on infant and child development.
In the study, not yet-peer reviewed and uploaded as preprint in medRxiv on Wednesday, researchers from Brown University examined data from an ongoing longitudinal study of child neurodevelopment, comparing scores in 2020 and 2021 to scores from 2011 to 2019.”

About health insurance

Updated Guidance Related to Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency [PHE]: “Specifically, CMS is revising the guidance in the December 2020 SHO in two key areas, as follows.
Extending the timeframe for states to complete pending eligibility and enrollment actions to up to 12 months after the month in which the PHE ends…
Completing an additional redetermination for individuals determined ineligible for Medicaid during the PHE” [Emphasis in the original]

Medicaid Programs Call for Medicare Coverage of Alzheimer’s Drug: “The National Association of Medicaid Directors (NAMD) is recommending that CMS approve Medicare coverage for Alzheimer’s disease therapies.
’The outcome of Medicare’s coverage decision for this therapy will have enormous ramifications for the Medicaid program,’ the Medicaid directors stressed. ‘Should Medicare not cover the drug, then Medicaid would become the primary source of coverage for duals and dramatically increase Medicaid spending.’
If Medicare does not cover aducanumab—an Alzheimer’s drug that has received FDA approval—then Medicaid spending could increase by approximately 250 percent nationwide, NAMD experts estimated. Some states could see spending increases of up to 500 percent.” And in a related article: Excellus BlueCross BlueShield Says It Won’t Cover Aduhelm

About diagnostics

New DNA Blood Test Could Pinpoint Cancer’s Source in the Body: Much has been written recently about so-called liquid biopsies- detecting tumors in the blood from DNA fragments. This “new test (called GETMap, for genetic-epigenetic tissue mapping) also measures a phenomenon called DNA methylation. Cells add molecular groups to certain DNA sequences to turn genes on and off; this so-called methylation fingerprint can reveal the original tissue source for the DNA.” Gene mapping most often does not pick up these crucial epigenetic changes.

About hospitals and health systems

Medicare Holds Off on Hospital Price Disclosure Fines for Now: CMS ”is giving hospitals time to adjust to its price transparency rule, so far refraining from penalizing providers despite recently proposing to increase sanctions for those that don’t comply…
The vast majority of hospitals—94.4%—haven’t met one or more of the requirements since the rule took effect Jan. 1, 2021, according to a recent sample of 500 hospital websites conducted by Patient Rights Advocate. Right now many hospitals are getting warning letters if they don’t comply.
Rather than rescinding or modifying the Trump-era rule, the Biden administration has also proposed tougher sanctions. The Centers for Medicare & Medicaid Services suggested increasing the penalty for noncompliant hospitals in a July proposed rule (RIN 0938-AU43) regulating outpatient payment rates for acute care hospitals. 
Hospitals can currently be fined up to $300 a day. If the proposal is finalized, the penalty would increase to at least $300 a day for smaller hospitals and $10 a bed a day for larger hospitals, but no more than $5,500 a day.”

About pharma

Optum quietly revamps online pharmacy, sells virtual care for cash: “UnitedHealth subsidiary Optum is offering virtual care and discounted drugs to patients who pay with cash, presenting new competition to digital health startups and telehealth providers..

Today's News and Commentary

About Covid-19

FDA authorizes third vaccine dose for immunocompromised people: “The Food and Drug Administration (FDA) on Thursday authorized a third dose of COVID-19 for certain people with compromised immune systems, a narrow move into the realm of booster doses amid a growing debate over their use.
The move will allow a third dose of both the Pfizer-BioNTech and Moderna vaccines, and applies to certain immunocompromised people, including those with organ transplants and those ‘diagnosed with conditions that are considered to have an equivalent level of immunocompromise,’ the FDA said.
The agency emphasized that the general public does not need a third dose at the moment.”

Change in Saliva RT-PCR Sensitivity Over the Course of SARS-CoV-2 Infection: “Saliva was sensitive for detecting SARS-CoV-2 in symptomatic individuals during initial weeks of infection, but sensitivity in asymptomatic SARS-CoV-2 carriers was less than 60% at all time points. As COVID-19 testing strategies in workplaces, schools, and other shared spaces are optimized, low saliva sensitivity in asymptomatic infections must be considered. This study suggests saliva-based RT-PCR should not be used for asymptomatic COVID-19 screening.[Emphasis added]”

Gov. Abbott argues San Antonio’s mask mandate will ‘shatter’ Texas’ ability to respond to pandemic: “Texas Gov. Greg Abbott and Attorney General Ken Paxton filed an appeal Thursday seeking to reverse a Bexar County judge’s temporary restraining order that allowed the county to mandate masks in school…
The temporary restraining order against Abbott’s executive order is only in effect until Monday, when a local district judge will determine whether the local governments can continue mandating masks…
Lawyers for the statewide officials argued that the restraining order ‘will have shattered’ the state’s ability to ‘carry out an orderly, cohesive, and uniform response to the COVID-19 pandemic.’”
As far as I can tell, the only response the ruling has “shattered” is the ability to implement a science-based initiative.

Herd immunity is 'mythical' with the Covid delta variant, experts say: “Achieving herd immunity with COVID-19 vaccines when the delta variant is spreading is "not a possibility," said Andrew Pollard, head of the Oxford Vaccine Group..
Pollard said that while COVID-19 vaccines may slow the spread of the virus — because in studies fully vaccinated but infected people appeared to shed less virus, giving the virus less opportunity to spread — new variants were likely to emerge that would also spread.”
Speaks to the need to both vaccinate and wear masks.

WHO Broadens COVID-19 Study to Feature Three Licensed Drugs: “Expanding its existing Solidarity trial, the World Health Organization (WHO) will test three additional anti-inflammatory drugs as potential treatments for COVID-19.
Solidarity PLUS will determine whether artesunate, imatinib and infliximab — all of which are already approved for other indications — might reduce the risk of death or hospitalization in patients with the disease, WHO reported. An independent expert panel selected the candidate medications, which will be donated by the manufacturers.”

Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents: “The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19.”

Despite obstacles, Native Americans have the nation’s highest COVID-19 vaccination rate: Despite poverty and remote living conditions, “data — collected by the U.S. Centers for Disease Control and Prevention — suggest that Native Americans are 24% more likely than whites to be fully vaccinated, 31% more likely than Latinos, 64% more likely than African Americans and 11% more likely than Asian Americans.”
The reason is the strong efforts by tribal leaders to promote the vaccine in the face of many deaths early in the pandemic.

About pharma

AHIP Letter Concerning National Coverage Determination Analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease: While the entire letter is a good summary of the issue, the insurance trade organization hedges its opposition with the following statement:
”While we do not believe CMS can conclude that aducanumab meets the Medicare coverage standard based on the risk of serious beneficiary harm and the lack of clinical benefit, we recognize that even if CMS agrees, CMS may still consider other statutory approaches that permit some degree of coverage under the Medicare program. In that context, an available approach under the Medicare statute would be for CMS to approve coverage only in connection with a CED [Coverage with Evidence Development]. As CMS has previously noted, an NCD involving CED is appropriate when CMS decides after a formal review of the medical literature that it will cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary.”

Despite pharma's pandemic push, consumer trust in the industry still comes down to costs: study: “A new study from Accenture shows a boomerang back to a familiar topic—drug costs…
The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more. Accenture surveyed 1,800 people in May and June about their healthcare experiences.”

About health insurance

Innovation At The Centers For Medicare And Medicaid Services: A Vision For The Next 10 Years: Chiquita Brooks-LaSure (Administrator, Centers for Medicare and Medicaid Services) is the lead author of this Health Affairs article. The beginning is a good review of recent CMMI initiatives and a call for simplification of its programs. It continues by offering areas for improvement for the future. Notably missing are implementation of evidence-based guidelines and reforms that would allow cost-benefit analyses to be used in care decisions.

Physician assistants will benefit with direct pay under CMS proposed rule: “In its proposed rule for the 2022 Physician Fee Schedule, CMS includes a section on billing for physician assistant services. It has people talking, but few know what it does – and does not – mean. 
If approved as a final rule, physician assistants (PAs) may choose to bill Medicare and be paid directly for their services, reassign their payment and incorporate as a solo or group practice comprised solely of PAs…
Section 403 of the Consolidated Appropriations Act of 2021 amends section 1842(b)(6)(C)(i) of the Social Security Act and removes the requirement that payment for services performed by PAs be made to their employer.”
The final rule is pending and awaits comment period closing on September 13.
If this provision is retained it could be one of the biggest changes in professional practice since physician licensure laws.

Oscar Health, Inc. Announces 2022 Market Expansion Plans, Culturally Competent Care Focus: “During the upcoming Open Enrollment period, the company plans to offer health insurance to individuals and families in 3 new states and 146 new counties.1 With this expansion, Oscar will have a footprint in a total of 22 states and 607 counties across its Individual & Family, Medicare Advantage, and Small Group (including Cigna+Oscar) plans.”

UnitedHealthcare loses Medicare overpayment appeal: 5 things to know: “In a 49-page opinion, the U.S. Court of Appeals for the District of Columbia Circuit reversed a 2018 decision that vacated Medicare's overpayment rule, which requires insurers to refund payment to CMS within 60 days if it learns a diagnosis lacks medical record support.
UnitedHealthcare had argued the overpayment rule was subject to "actuarial equivalence." However, the court ruled actuarial equivalence doesn't apply to the overpayment rule, and there's no legal basis for UnitedHealthcare's claim.”

UnitedHealth, Change Healthcare strike timing agreement with DOJ: 5 things to know: “UnitedHealth Group and Change Healthcare entered an agreement with the Department of Justice that dictates when the organizations can consummate their $13 billion proposed deal…
UnitedHealth and Change agreed to wait at least 120 days after certifying compliance with the request for information to consummate the deal, according to an Aug. 7 filing with the Securities and Exchange Commission. Both organizations agreed to not certify compliance with the request before Sept. 15. 
The organizations could complete the acquisition before the 120-day period ends if they get a written notice saying the DOJ has closed its investigation into their deal.”

UnitedHealthcare to pay $15.6M in mental health parity settlement: “UnitedHealthcare will pay $15.6 million to settle federal and state investigations into mental health parity, the Department of Labor announced Thursday.
The settlement includes $13.6 million in payments to members for wrongfully denied claims as well as just over $2 million in penalties and lawyers fees, DOL said.
An investigation by DOL's Employee Benefits Security Administration found that UnitedHealth would reduce reimbursement rates for out-of-network behavioral health services and would flag members who were undergoing mental health treatment for utilization reviews.
UnitedHealthcare also failed to sufficiently disclose information about its practices to plan sponsors and members, according to DOL.”

Anthem partners with CareMax to open 50 medical centers: “Miami-based CareMax, a senior healthcare provider with an emphasis on value-based care, penned a partnership with Anthem that will lead to the duo opening 50 medical centers around the country.
The medical centers will primarily be created in areas where Anthem is focusing value-based care efforts, according to the Aug. 13 announcement. Some of the identified states include Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut and Virginia.”

How Would Drug Price Negotiation Affect Medicare Part D Premiums?: “Under drug price negotiation, premium savings for Medicare beneficiaries are projected to increase from an estimated 9% of the Part D base beneficiary premium in 2023 to 15% in 2029. Medicare’s actuaries have estimated that the Part D base beneficiary premium, which covers the cost of basic Part D coverage, will increase from around $440 per year in 2023 to around $560 in 2029. The $14 billion in aggregate Part D premium savings from drug price negotiation over a decade translates into estimated per capita savings for Part D enrollees who pay premiums of $39 annually in 2023, increasing to $85 annually in 2029. This translates to savings of 9% of the base beneficiary premium in 2023 and 15% in 2029.”
See Figure 1 for a quick view of the impact.

About healthcare IT

Amwell expects fewer telehealth visits in fall, winter as delta variant creates uncertainty: “The company is projecting an $8 million impact on its 2021 revenue as a result of the drop in projected virtual care visits. Amwell adjusted its 2021 revenue guidance to between $252 million and $262 million from the previous range of $260 million to $270 million, executives said during the company's second-quarter 2021 earnings call Wednesday.
’The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,’ said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.”

Another big company hit by a ransomware attack: You know you are in trouble when your IT consultant is a ransomware victim: “Accenture, the global consulting firm, has been hit by the LockBit ransomware gang, according to the cybercriminal group's website. Accenture's encrypted files will be published by the group on the dark web on Wednesday unless the company pays the ransom, LockBit claimed, according to screenshots of the website reviewed by CNN Business and Emsisoft, a cybersecurity firm.”

About hospitals and health systems

Mississippi braces for ‘failure’ of hospital system due to covid-19 surge and lack of ICU beds: “A surge in coronavirus patients and a shortage of health-care workers and intensive care unit beds have pushed Mississippi’s hospital system to the brink of “failure,” state health officials warned Wednesday, saying drastic federal intervention was needed to help the state grapple with the thousands of new daily infections that have overwhelmed doctors and nurses.
Mississippi is averaging nearly 2,700 new covid-19 infections a day in the past week — a 54 percent spike in the past seven days…”

Former Broward Health director gets more than 3 years in prison for taking kickbacks: “In his role as procurement director, Mr. Bravo was responsible for deciding which vendors would provide Broward Health with products and services, including healthcare products, linens, compression sleeves and printer repair.
According to prosecutors, Mr. Bravo used his role to orchestrate a bribery and kickback scheme between 2008 and 2015 that involved four vendors.”

FTC’s Merger Review Process Change Muddies Deal-Closing Outlook: This article is in this section because most of the FTC’s scrutiny in healthcare has centered on hospital/health system mergers. “A shift in the Federal Trade Commission’s merger review process will add more risk management work for companies hoping to quickly wrap up mergers.
The FTC said this month it will tell some companies that it lacks resources to complete an initial review of their mergers and acquisitions within 30 days, as generally laid out in the Hart-Scott-Rodino (HSR) Act. 
The FTC will now send a letter to companies doing deals that can’t be fully reviewed within 30 days that its investigation remains open and their deal may be subsequently declared unlawful.”

Today's News and Commentary

About health insurance

Alignment Healthcare plans expansion into 16 new markets for 2022: “Startup Medicare Advantage insurer Alignment Healthcare is expanding into 16 new markets for the 2022 plan year, nearly doubling its footprint.
Alignment's plans will be available in 38 markets across Arizona, California, Nevada and North Carolina next year, reaching 6.9 million potential beneficiaries. The expansion is pending regulatory approvals.”

HHS sued over insurance price transparency rule: “The U.S. Chamber of Commerce and an affiliate are suing HHS to block the enforcement of a regulation that aims to increase insurance plan price transparency, according to court documents.
The U.S. Chamber of Commerce and Tyler Area Chamber of Commerce allege that HHS exceeded its authority by adopting provisions that they claim will reduce competition, raise costs to consumers and cost millions to implement.”

Kansas paid $1.3M to Medicaid contractors to care for dead people: “In the same release, the state inspector general said an audit also discovered over $1.6 million had been used to pay for claims for beneficiaries who exceeded the 12-month lifetime eligibility limit. These payments occurred between 2018 and 2021.”

About Covid-19

Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients: “We conclude that a third-dose booster Covid-19 vaccine should be considered, in conjunction with regulatory approval, for transplant recipients who have received two doses of mRNA-1273.”

A majority of Americans in highly vaccinated counties now live in covid hot spots, Post analysis finds: “Two-thirds of Americans in highly vaccinated counties now live in coronavirus hot spots, according to an analysis by The Washington Post, as outbreaks of the highly transmissible delta variant — once concentrated in poorly vaccinated pockets — ignite in more populated and immunized areas still short of herd immunity…
Living in a hot spot while vaccinated today is much safer than living in a hot spot while unvaccinated last summer. High-vaccination states have one-third the number of new cases per capita as low-vaccination states.
Hospitalization rates in states with less than 40 percent of their population fully vaccinated are four times higher than states that are at least 54 percent vaccinated, The Post found.”
The graphic maps are highly explanatory.

Breakthrough COVID-19 infection risk may differ with vaccine type, early Mayo Clinic research suggests: “People who received the Moderna COVID-19 vaccine may be less likely to experience a breakthrough infection compared to Pfizer vaccine recipients, findings published Aug. 8 in preprint server medRxiv suggest.”

Supreme Court won’t block Indiana University vaccine mandate as Justice Barrett rejects student plea: “Justice Amy Coney Barrett on Thursday rejected a plea from a group of Indiana University students to stop the university’s requirement that all students be vaccinated against the coronavirus.
Barrett, who received the request because she is the Supreme Court justice tasked with appeals from that region of the country, did not give a reason.”

About pharma

U.S. Veterans Health Administration turns down Biogen Alzheimer's drug: “The U.S. Veterans Health Administration (VHA) will not include Aduhelm, the $56,000-a-year Alzheimer's drug made by Biogen Inc and Eisai Co Ltd, on its list of approved drugs due to a lack of evidence that it is effective as well as safety concerns, the agency said on Wednesday.”

Affordable naloxone is running out, creating a perfect storm for more overdose deaths, activists say: “After a manufacturing issue halted Pfizer’s production of the single-dose injectable naloxone in April, groups that distribute a significant amount of the lifesaving medicine say they are facing an unprecedented obstacle to reverse drug overdoses as they reach an all-time high. Organizers say the insufficient supply has been felt unequally across the country.”

Pfizer halted Chantix distribution then recalled a dozen batches. Now, a generic's here to help fill the shortage: “Trying to fill a recent shortage for Pfizer’s smoking med caused by safety concerns, the FDA has approved Par Pharmaceuticals’ copycat version, also known as varenicline, “well ahead” of its expected review date, the agency said a statementon Wednesday.
Though Pfizer’s generic rival Par Pharmaceuticals received the FDA’s special expedited treatment, impending copycat competition wasn’t unexpected given Chantix lost its main patent in November last year.”

About healthcare IT

HIMSS21 Roundup—Epic rolls out customer story-sharing site; Young inventor's advice for health tech innovators

Today's News and Commentary

About health insurance

More than 2.5 Million Americans Gain Health Coverage During Special Enrollment Period: “New data released [yesterday] by the Centers for Medicare and Medicaid Services (CMS) shows more than 2.5 million people enrolled in health coverage on HealthCare.gov and state Marketplaces during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which will close in five days on August 15th. Additional data released by CMS today shows that a record high of nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance Program (CHIP) as of March 2021.”

Senate passes infrastructure bill that restarts sequester cuts, delays rebate rule: “The package would reinstall starting in 2022 a 2% payment cut to all Medicare payments to providers. The cut was installed as part of sequestration, but Congress paused it last year at the onset of the pandemic.”

A Post-Merger Integration Agenda for Health Care Payers: From BCG: A good summary of the payer M&A activity over the past few years.

CMS pulls Medicaid work rules in 3 more states: “Health officials in Ohio, South Carolina and Utah received word from CMS on Aug. 10 that Medicaid work requirements would be revoked in their states…”

About Covid-19

Texas sees most COVID-19 hospitalizations in 6 months: “The third wave of COVID-19 in Texas continues to tax the state’s health care systems as 10,000 COVID-19 sufferers have been hospitalized for the first time since early February, state health officials reported.
Meantime, local governments and courts continue to chip away at Gov. Greg Abbott’s ban on mask and social distancing mandates as a state district judge in San Antonio granted a temporary restraining order to allow San Antonio and Bexar County to require public school students to mask up and quarantine unvaccinated students exposed to COVID-19.”

Novavax Says U.S. Will Pause Funding for Production of Its Vaccine: “Novavax, the Maryland firm that won a $1.75 billion federal contract to develop and produce a coronavirus vaccine, said on Thursday that the federal government would not fund further production of its vaccine until the company resolves concerns of federal regulators about its work.
The firm’s disclosure came in a quarterly filing with the Securities and Exchange Commission.”

KFF COVID-19 Vaccine Monitor: Parents and the Pandemic: Among the highlights:
— “As children around the country head back to school, nearly half of parents of children ages 12-17, the age group currently eligible to receive a COVID-19 vaccine, say their child has already been vaccinated (41%) or they will get the vaccine right away (6%)…
— A majority (58%) of parents of 12-17 year-olds say their child’s school should not require students to be vaccinated for COVID-19, and a similar share (54%) of parents of all school-age children say schools should not require vaccination even once the FDA has fully approved the use of a COVID-19 vaccine in children.
— More than six in ten (63%) of all parents of children who attend school think their child’s school should require unvaccinated students and staff to wear masks at school, although most Republican parents (69%) oppose such a requirement and parents of unvaccinated children are evenly divided.”

3rd COVID shot highly potent in Israel's immunocompromised, early study shows: “According to early results from research carried out at Beilinson Medical Center in Petah Tikva, the COVID-19 vaccine booster shot is highly effective among immunocompromised people, doubling the number of people who developed antibodies among patients who have received heart, lung or kidney transplants…” In a related article: Israel’s Covid infections surge as government rolls out booster shots: “Almost 80 per cent of the adult population has been fully vaccinated, one of the highest rates in the world, but more than 6,000 people tested positive for Covid-19 on Monday, according to the health ministry. Nearly 650 people were in hospital and 400 of them were in serious condition, it said, without indicating how many had already been vaccinated. Just under 5 per cent of coronavirus tests were coming back positive, in a sign that the nation was in the midst of a major Covid increase…”

How to reach the unvaccinated: the risks of bribery and coercion: A good overview of what countries are doing and the pros and cons of the approaches. A couple comments: “ ‘As vaccine supplies increase in the developed world, governments are rushing to introduce incentives and mandates to increase uptake — without always thinking through the consequences that it might harden the views of those who are hesitant,’ says Professor Heidi Larson, founding director of the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine.
[Stephen Reicher, a professor of psychology at the University of St Andrews] notes that incentives also come with risks. ‘Some scientific literature suggests that they can decrease what is called your intrinsic motivation,” he says. “In other words, you get vaccinated because you get a reward for it, not because you believe it is the right thing to do.’”

BD and CerTest Biotec Gain CE Mark for Test for COVID-19 Variants: “The test, which runs on the BD MAX real-time PCR platform, can distinguish between the original COVID-19 virus and three variants, Alpha, Beta and Gamma, the companies said.
The test kit also includes three options for specimen collection: nasopharyngeal, oropharyngeal and saliva.”

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021: Published yesterday from the CDC:
“Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination…
[However], continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected.”

COVID-19 vaccine safety update: The European Medicines Agency (EMA) has requested more data from BioNTech about possible certain possible vaccine-related conditions: erythema multiforme, glomerulonephritis, nephrotic syndrome, and “menstrual disorders.” All are rare and not a reason to avoid the vaccine.

At least 1 million people got unauthorized third booster shot: “The Centers for Disease Control and Prevention estimates that more than 1 million people who have received the Moderna or Pfizer vaccine have gone back for an unauthorized third booster shot.
Florida is among the states reporting the highest number of people opting for a booster shot, followed by Ohio, California, Illinois and Tennessee.”

CDC guidance now official: Pregnant women should get coronavirus vaccine: “The Centers for Disease Control and Prevention recommended Wednesday that pregnant women be vaccinated against the coronavirus, updating its advice after it found no increased risk of miscarriage among those who have been immunized.”

Alabama Just Tossed 65,000 Vaccines. Turns Out It's Not Easy To Donate Unused Doses: While Alabama is in the headline, the article discussed how many states need to dispose of outdated vaccines and why donating them is not easy.

About healthcare professionals

High trust in doctors, nurses in US, AP-NORC poll finds: “At least 7 in 10 Americans trust doctors, nurses and pharmacists to do what’s right for them and their families either most or all of the time, according to the poll from the University of Chicago Harris School of Public Policy and The Associated Press-NORC Center for Public Affairs Research.
The poll shows high levels of trust among both Democrats and Republicans; men and women; and white, Black and Hispanic Americans…
Polling from the nonprofit Kaiser Family Foundation in June also showed people trusted doctors for information about the vaccine more than other sources like the Centers for Disease Control and Prevention and Dr. Anthony Fauci, the U.S. government’s top infectious disease expert.”

About the public’s health

Screening for Gestational DiabetesUS Preventive Services Task Force Recommendation Statement: “The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes in asymptomatic pregnant persons before 24 weeks of gestation. (I statement)”

Perceptions on Barriers and Facilitators to Colonoscopy Completion After Abnormal Fecal Immunochemical Test Results in a Safety Net System: “In this qualitative study of 21 primary care physicians (PCPs) and staff members, barriers to follow-up colonoscopy completion included environmental factors (ie, social determinants of health and organizational factors) and patient cognitive factors. Resources that addressed these barriers (eg, insurance assistance, appointment reminders, and bowel preparation education) were associated with improved colonoscopy completion.”

Trends in Consumption of Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018: “In this serial cross-sectional study of nationally representative data from 33 795 US youths aged 2-19 years, the estimated percentage of total energy consumed from ultraprocessed foods increased from 61.4% to 67.0%, whereas the percentage of total energy consumed from unprocessed or minimally processed foods decreased from 28.8% to 23.5%.”

Religious Groups Win Pass On Abortions, Transgender Care: “A Texas federal judge has ruled that several religious medical providers can't be punished by the federal government for refusing to provide abortions or gender transition-related care, despite an anti-bias provision in the Affordable Care Act.”

About pharma

Groups make own drugs to fight high drug prices, shortages: A good overview of how non-pharma companies are producing drugs to fight shortages and high costs.

Judge Limits Attorney Contingency Fees to 15 Percent in $26 Billion Opioid Settlement: “A federal judge has capped contingency fees at 15 percent for lawyers representing plaintiffs poised to earn large amounts from the pending $26 billion opioid lawsuit settlement by the three largest U.S. drug distributors and Johnson & Johnson (J&J).”

Ex-Roche Employee Sentenced to Prison for Cheating the Drugmaker Out of Nearly $10 Million: “The defendant and an accomplice pleaded guilty to commercial fraud, document forgery and commercial money laundering, after being charged with embezzling the funds from January through August 2017.”

Big Pharma’s Q2 growth, ranked: Regeneron, Pfizer lead the way as sales rebound from pandemic depths: “More than half of Big Pharma companies reported revenue increases greater than 15% over the same quarter in 2020, which was marred by lockdowns and the shock to the economic system that ensued at the start of the pandemic…
Companies that registered the most dramatic revenue growth were the ones that have developed COVID-19 treatments. In fact, this was the case for all six of the firms that exceeded a 20% increase, including Regeneron (up 163%) with $2.59 billion in sales for its antibody drug REGEN-COV and Pfizer (92%) with $7.8 billion in COVID-19 vaccine sales.”
Check the graphic for data on specific companies.

Perfect packaging? J&J's latest innovation challenge crowdsources single dose ideas:
“…Johnson & Johnson Innovation looks to crowdsource the best ideas in single-dose packaging for its latest JLABS Quickfire challenge.
The contest focuses on single-dose packages but also aims for ideas that incorporate child safety measures, environmentally friendly materials and adherence helpers…
The new unit-dosing challenge follows up on a Pill Protect safer medicine storage challenge that ended in July. Gatekeeper Innovation won with its solution for a child-resistant prescription pill minder. J&J kicked off that challenge with an eye toward making over the popular multiday pill boxes that people fill weekly with their meds…”
A great example of “listening to the voice of the customer.”

About healthcare IT

Telemedicine company owner indicted in $784M fraud scheme: Another Medicare, multi-year scam:
”According to prosecutors, Mr. Harry and his co-conspirators solicited kickbacks and bribes from durable medical equipment suppliers and marketers in exchange for orders. His telemedicine companies also allegedly paid physicians to write orders for braces and other equipment regardless of medical necessity. The scheme resulted in the durable medical equipment suppliers fraudulently billing Medicare more than $784 million, of which Medicare ended up paying about $247 million. 
Prosecutors also say Mr. Harry directed suppliers not to pay his telemedicine companies but instead to pay shell companies opened in straw owners' names in the U.S. and foreign countries in an effort to conceal the scheme. Mr. Harry committed income tax evasion between 2015 and 2018 by receiving the proceeds in the accounts of shell companies, according to the indictment.”

TytoCare Launches New Integration with Epic for Seamless Asynchronous Telehealth Exams: “TytoCare, the global health care industry's first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, has expanded its integration within MyChart enabling frictionless asynchronous workflow. The integrated workflow enables health systems to easily access TytoCare-generated data in a patient's EHR (Electronic Health Record), clinicians to access TytoCare exam data directly within Epic, and seamless remote patient monitoring.
The new integration was developed as a result of a collaboration between TytoCare and University of Miami Health System in June 2020.”

Fitbit moves deeper into healthcare with LifeScan deal to combine diabetes devices, consumer wearables: “Smartwatch maker Fitbit inked a deal with LifeScan to integrate its health tracking apps with the company's glucose monitoring devices to help patients with diabetes management.”

HIMSS21 Update

About healthcare quality

NCQA launches program to streamline quality reporting: “The National Committee for Quality Assurance announced a program this week geared toward ensuring the validity of clinical data used for quality reporting and other initiatives.  
The Data Aggregator Validation program is aimed at giving health plans, government entities and care delivery organizations confidence in the validity of their clinical data. It does so, says the NCQA, by evaluating how organizations ingest, transform and output that data. “

Today's News and Commentary

About the public’s health

Association of State Opioid Prescription Duration Limits With Changes in Opioid Prescribing for Medicare Beneficiaries: “This cohort study found that in the Medicare population, total days of opioid prescribed per enrollee decreased from 2013 to 2018, with a slightly greater reduction in states with laws restricting initial opioid prescriptions to 7 days or less, suggesting a significant but limited outcome for such legislation.”

About hospitals and health systems

Mass General Brigham posts $2.9B gain over 9 months: “Looking at the first nine months of 2021, revenues were up nearly 18 percent year over year. Mass General Brigham ended the first three quarters of this year with operating income of $507.9 million, including $232 million in Coronavirus Aid, Relief and Economic Security Act funds to reimburse the system for lost revenue and higher expenses tied to the pandemic as well as $30 million in ACA risk corridor program subsidies for insurance coverage provided from 2014-16. In the first nine months of 2020, the system reported an operating loss of $506 million. 
Mass General Brigham reported a nonoperating gain of $2.39 billion in the first nine months of 2021 and an overall gain of $2.9 billion. In the same period last year, the system reported a nonoperating loss of $192.2 million and an overall loss of $698 million.”
The results do show attention to efficiencies, but also highlight the importance of government funds as well as non-operating income, like investments. (The S&P was up 19% the first three quarters of this calendar year.)

About pharma

Pharmacies Face Extra Audit Burdens That Threaten Their Existence: “According to data from PAAS National, a pharmacy audit assistance service, while the number of pharmacy audits in 2020 declined nearly 14% from the year before, the overall number of prescriptions reviewed went up 40%. That meant pharmacies had to provide more documentation and stood to lose much more money if auditors could find any reason — even minor clerical errors — to deny payments.
The average audit in 2020 cost pharmacies $23,978, 35% more than the annual average over the previous five years, the PAAS data shows. And the number of prescriptions reviewed in September and October was fourfold over what PAAS members had seen in previous years.”

Performance evaluation of a prescription medication image classification model: an observational cohort: A fascinating look at the use of AI in making sure the medication filling process is accurate. One finding, however, was that a major source of mistakes was “system error”… “medications that share similar color, shape, and imprints with at least one common character accounted for almost 50% of the errors.” If the FDA reviewed such features before allowing manufacture, it would cut down on errors by both machines and humans.

About health insurance

CVS Health launches first nationwide virtual primary care solution: “Aetna Virtual Primary Care is available for self-funded employers and provides eligible members access to health services remotely and in person…”
Among its features are $0 co-pay for virtual primary care visits and select in-person services at MinuteClinic® and CVS® HealthHUB™ locations (which starts after the deductible is met) and in-person visits with in-network health care providers with no referral requirements.
”This new care experience is powered by Teladoc Health's longitudinal, physician-led care team model…”

Insurers came back down to Earth in Q2 following sky-high profits a year ago: A good, short overview of the top six companies in this sector.

Health Care Service Corporation Launches Biggest Expansion of Medicare Advantage Plans in Company's History: “Health Care Service Corporation (HCSC), which operates health plans in Illinois, Montana, New Mexico, Oklahoma and Texas, announced the company is increasing its footprint in the Medicare Advantage market to serve more than 90 new counties, increasing access to new coverage options for more than 1.1M additional Medicare-eligible individuals. The expansion is the company's largest service area and product expansion in its history, particularly in rural and underserved areas.”

About healthcare IT

This week is the HIMSS annual conference. People are attending in person, though in reduced numbers. For free updates subscribe to STAT. Here is another update.

Cigna Launches World's First Voice-Activated Stress Test: Test your stress level through the links provided in this article.

New Salesforce Care from Anywhere Innovations Improve Patient Access and Deepen Relationships: Interesting to read what this company is doing in the healthcare space.

Today's News and Commentary

About Covid-19

Myocarditis and Pericarditis After Vaccination for COVID-19: “Two distinct self-limited syndromes, myocarditis and pericarditis, were observed after COVID-19 vaccination. Myocarditis developed rapidly in younger patients, mostly after the second vaccination. Pericarditis affected older patients later, after either the first or second dose.”
The purpose of the article is to define two groups for these rare complications.

CDC: Reinfection more likely for unvaccinated who had COVID-19 than for vaccinated: “People who were infected with COVID-19 earlier in the pandemic, but who opt to not get vaccinated against the virus, are more than twice as likely to get sickened again compared with those who receive the shot, according to data released Friday by the Centers for Disease Control and Prevention.”

Coronavirus booster shots for the immunocompromised expected to be authorized soon: “The extra shots are expected to be authorized within days or weeks, according to federal officials who spoke on the condition of anonymity because the plan has not been announced.”

U.S. Military Will Mandate Vaccine for Troops: “The Pentagon will seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than next month, the Biden administration announced Monday.”

The social network for doctors is full of vaccine disinformation: “Doctors on the industry networking site Doximity are finding their news feed inundated with anti-vaccine comments from fellow physicians.”

About the public’s health

Bronchitis the Leader at Putting Children in the Hospital: ”More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.” It was the #1 diagnosis for males and #2 for females (after depression).

Prevalence of bacterial contamination of touchscreens and posterior surfaces of smartphones owned by healthcare workers [HCWs]: a cross-sectional study: “Eighty-four HCWs participated in this study. The touchscreen and posterior surface were contaminated in 27 (32.1%) and 39 (46.4%) smartphones, respectively, indicating that the posterior surface was more frequently contaminated (p = 0.041). Bacillus species and coagulase-negative staphylococci were isolated from each surface of the smartphones.”

Humans have pushed the climate into ‘unprecedented’ territory, landmark U.N. report finds: Today, the Intergovernmental Panel on Climate Change “issued its latest and most dire assessment about the state of the planet, detailing how humans have altered the environment at an ‘unprecedented’ pace and cautioning that the world risks increasingly catastrophic impacts in the absence of rapid greenhouse gas reductions.
The landmark report, compiled by 234 authors relying on more than 14,000 studies from around the globe, bluntly lays out for policymakers and the public the most up-to-date understanding of the physical science on climate change. Released amid a summer of deadly fires, floods and heat waves, it arrives less than three months before a critical summit this November in Scotland, where world leaders face mounting pressure to move more urgently to slow the Earth’s warming.”

About health insurance

The Impact of the COVID-19 Pandemic and Recent Federal Policies on Small Business Health Insurance:

• “Small businesses’ health coverage offerings remained relatively stable amid the COVID-19 pandemic, contrary to some early predictions.

• The share of small employers offering comprehensive health benefits has steadily declined over the last two decades, but employers that continue to offer benefits recognize its importance in attracting and retaining skilled employees.

• Many small employers are shifting to coverage exempt from Affordable Care Act rules in response to rising costs, resulting in an unsettled market.”

Democrats reintroduce legislation to create Medicaid-based public option: “Nearly 20 Senate Democrats reintroduced legislation Friday to create a new Medicaid-based public option, reinforcing their commitment to a key priority.
But the legislation isn't certain to become law, as it has not been added to a $3.5 trillion infrastructure package that includes other reforms on drug pricing and expanding Medicare benefits.”

About healthcare IT

Digital Health Trends 2021: From Iqvia, this report is well-worth reading, especially if you are involved or interested in this sector.
Here are some overall highlights:
”Health-related mobile applications available to consumers on top app stores worldwide now surpass 350,000, with more than 90,000 digital health apps added in 2020 — an average of more than 250 apps per day.... Mental health, diabetes and cardiovascular disease-related apps now account for almost half of disease-specific apps. 
Digital therapeutics (DTx) and digital care (DC) products and tools — which incorporate software as a means to treat, prevent or manage specific diseases or conditions — have been proliferating, and more than 250 such products are now identified, including about 150 products that are commercially available… 
At least 25 DTx products have been granted market authorization through regulatory processes and another 23 are commercially available, with indications predominantly in the mental health and behavior modification areas, and an additional 89 are in earlier stages of development and evidence generation.”

GE Healthcare moves imaging, clinical analytics platforms to Amazon Web Services cloud: “GE Healthcare will begin moving several of its software platforms to the AWS cloud, making it easier for healthcare providers and artificial intelligence developers alike to access clinical data to improve patient care.
First to make the jump to the cloud are GE’s Edison Health Services platform and its newest AI-powered imaging tool, the Edison True PACS picture archive and communication system, which was specifically designed to be hosted on the cloud in order to reduce data storage costs and speed up the process of integrating AI into under-resourced clinics.”

App-Based Feedback for Rehabilitation Exercise Correction in Patients With Knee or Hip Osteoarthritis: Prospective Cohort Study: “Motion Coach (Kaia Health GmbH) provides audiovisual feedback on exercise execution in real time on conventional smartphones…
There was no detectable difference in levels of interrater agreement between Motion Coach vs physiotherapists and between physiotherapists in any of the 6 exercises…
The results demonstrated that Motion Coach is noninferior to physiotherapist evaluations…These results confirm the ability of Motion Coach to detect user form during exercise and provide valid feedback to users with musculoskeletal disorders.”

Altoida's Alzheimer's-predicting smartphone app snags FDA breakthrough status: “Altoida’s technology uses artificial intelligence to analyze cognitive test results to determine whether a case of mild cognitive impairment will escalate into Alzheimer’s within a year…
The system is the product of more than 20 years of cognitive research, Tarnanas said. It comprises a slate of neurological tests for users aged 55 and up and AI software to analyze the results of those tests.
The assessment portion of the system takes 10 minutes to complete and can be accessed on a user’s own smartphone or tablet. It focuses on measuring 11 specific areas of the brain research has suggested are linked to the onset of Alzheimer’s.”

These Algorithms Look at X-Rays—and Somehow Detect Your Race: “The study authors and other medical AI experts say the results make it more crucial than ever to check that health algorithms perform fairly on people with different racial identities. Complicating that task: The authors themselves aren’t sure what cues the algorithms they created use to predict a person’s race.”

Allscripts reports double-digit growth in its Veradigm analytics business as it eyes potential M&A: “Allscripts reported a particularly strong quarter in its life sciences data business within the Veradigm segment, both for in-quarter revenue as well as new partnership development, Poulton said.
The company's Veradigm business has the largest linked electronic health records claims patient database available for research, sourced from and directly connected to clinical platforms.
Allscripts expects those double-digit gains to continue for the rest of 2021.”

About pharma

CMS proposes pulling model that ties Part B drug prices to those paid overseas: “The Biden administration has pulled a Trump-era regulation that ties Medicare Part B prices for certain products to prices paid overseas.
The proposed rule, released Friday by the Centers for Medicare & Medicaid Services, comes in response to a series of legal defeats that the Biden administration faced over the controversial model.
The model would tie the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries.”

GoodRx inks deal with Surescripts to provide information on cash prices for drugs: “The partnership with GoodRx will enable Surescripts to deliver drug discount price information to prescribers when they are prescribing medications for uninsured patients and patients whose price information isn’t already available from their pharmacy benefit manager (PBM) or health plan, according to the companies.
Surescripts' real-time prescription benefit technology delivers cost information in the electronic workflow so prescribers can make more informed decisions and address patient prescription cost concerns at the point of care.”

About healthcare quality

CMS maintains patient safety measure after pushback from Leapfrog: “The ‘Death Among Surgical Inpatients with Serious Treatable Complications’ safety measure, also known as Patient Safety Indicator 4, or PSI-4, will remain in place for now, per CMS Inpatient Prospective Payment System final rule for 2022.”

About healthcare professionals

2021 REVIEW OF PHYSICIAN AND ADVANCED PRACTITIONER RECRUITING INCENTIVES: From Merritt Hawkins, their 28th annual report. Note it also includes PAs and NPs.

Today's News and Commentary

About Covid-19

California to mandate COVID-19 vaccines for health workers: “California will require all of its roughly 2.2 million health care workers and long term care workers to be fully vaccinated by Sept. 30 as the nation’s most populous state is losing ground in the battle against new infections of a more dangerous coronavirus variant.
The order, issued Thursday by the California Department of Public Health, is different than what Democratic Gov. Gavin Newsom said last month when he announced health care workers would have the choice of either getting vaccinated or submitting to weekly testing.”
Many healthcare facility managers are concerned that if they require employee vaccination, they will lose employees in a tight job market. If the state requires all such businesses to vaccinated employees, it substantively removes that threat.

South African study shows high COVID protection from J&J shot: “…the single-shot J&J vaccine offered 91% to 96.2% protection against death, while offering 67% protection against hospitalisation when the Beta coronavirus variant dominates and about 71% protection against hospitalisation when the Delta variant dominates.”

Vaccine Mandates Are Lawful, Effective and Based on Rock-Solid Science: This is an excellent summary and a “must read.”
“The DOJ and EEOC specifically stated that employer mandates may occur even under an EUA…
States have long had the constitutional authority to mandate vaccinations, which the Supreme Court has upheld twice, first in 1905 and then in 1922. The federal government, however, has limited power to mandate vaccines. It can only require them to prevent transmission of a dangerous infectious disease across state lines or international borders. The federal government has never sought to require nationwide vaccinations, and the courts probably would not allow it. To date, all state government mandates have been for fully approved vaccines. Thus, it is likely cities and states would wait to mandate COVID-19 vaccines until they are fully licensed.”

A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on: “After months in the doldrums, one of the world’s largest trials of COVID-19 treatments is finally restarting. Solidarity, a global study led by the World Health Organization (WHO), will test three new drugs in hospitalized COVID-19 patients: the cancer drug imatinib, an antibody named infliximab that is used to treat autoimmune diseases, and artesunate, an antimalarial.
The medicines have been shipped to Finland, the first country to have all approvals in place, says John-Arne Røttingen of the Norwegian Institute of Public Health, who chairs the study’s executive group. ‘I expect that the first patients will probably be recruited there any day,’ he says. Other countries could soon join SolidarityPlus, as the new phase has been dubbed; more than 40 are in the process of getting ethical and regulatory approvals.”

FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks: “The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
The Biden administration is pushing for the swift release of a booster strategy because some populations—people age 65 or older and people who are immunocompromised, as well as those who got the shots in December or January shortly after they were rolled out—could need boosters as soon as this month, two of the people said.”

Moderna's COVID-19 vaccine sales surge to $4.2 billion during Q2: “Moderna said Thursday that it generated sales of $4.2 billion for its COVID-19 vaccine mRNA-1273 during the second quarter, delivering 199 million doses in the period, for a total of 302 million doses so far this year. The vaccine comprised the bulk of Moderna's quarterly sales, which totalled $4.4 billion in all when grant revenues were taken into account, coming in slightly ahead of analyst expectations and towering over the $67 million it made in the prior-year period.
Company profit surged to $2.8 billion in the second quarter, beating estimates of $2.5 billion, whereas it had recorded a loss of $117 million the same time last year.”

Novavax's latest COVID-19 vaccine delay sends shares tumbling nearly 20%: “The latest roadblock—which will advance the timeline by just a couple weeks—spurred a 17.25% drop in Novavax's shares to about $195 apiece as of 10:41 a.m. ET Friday morning. It seems investors are fed up with delay after delay.”

About pharma

Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbochar”ge work: “In data dropped rather quietly during second-quarter earnings this week and to little fanfare, Pfizer said a challenge study, where vaccines were given to 62 adults under 50 who were then intentionally infected with RSV to see if the shot worked, showed ‘100% observed efficacy against mild to moderate symptomatic infection resulting from RSV.’
This is only a peek from the phase 2a test, which is set up to assess the immunogenicity and efficacy of the bivalent protein-based vaccine candidate, RSVpreF.”

Express Scripts Awarded 7-Year TRICARE Pharmacy Program Contract: “The U.S. Department of Defense today awarded Express Scripts, an Evernorth company, a contract for the administration of the TRICARE Pharmacy Program, Fifth Generation. Under the new contract, Express Scripts will serve 9.6 million active-duty service members, their family members, and retirees through 2029.”

Class-action lawsuit alleges 4 drugmakers colluded to restrict insulin sales to 340B contract pharmacies: “The class-action lawsuit alleges that Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca colluded in the summer of 2020 to restrict offering discounted products to 340B contract pharmacies.”

Gilead cracks down on fake versions of popular HIV drugs Biktarvy, Descovy being sold at US pharmacies: “Counterfeit versions of two of Gilead Sciences’ most popular HIV drugs are circulating in the U.S., threatening the health of people taking them.
Gilead’s original Biktarvy and Descovy have been replaced by fake versions at some pharmacies, Gilead warned Thursday. Unauthorized distributors were able to sell fake drugs to retailers; and then, ‘genuine Gilead bottles’ were filled with fake tablets, the company said.”

GSK again scores $235M in 'skinny label' case, but court admits it's 'unclear what Teva even did wrong': Read the whole story. It is a crazy, confusing exposition of the application of drug patent regulations.

About health insurance

Innovative Approaches to Addressing Social Determinants of Health for Medicare Advantage Beneficiaries: “On behalf of the Better Medicare Alliance's Center for Innovation in Medicare Advantage, NORC at the University of Chicago (NORC) assessed the current landscape of SDOH services within Medicare Advantage…
The new supplemental benefit authorities have been well received by health plans, with an explosion of participation in SSBCI’s [Special Supplemental Benefits for the Chronically Ill]-primarily health-related benefits to 845 separate plans in 2021, up from 245 in 2020 (the first year of SSBCI benefit availability).xxiv The top benefits offered in 2021 included Meals, Food and Produce, Social Needs Benefit, Pest Control, and Non- Medical Transportation. All health plans interviewed for this report described participating in SSBCI, with many enthusiastic about the results.”

Ascension Michigan to Pay $2.8 Million to Resolve False Claims Act Allegations: “Ascension Michigan and related hospitals… have agreed to pay $2.8 million to resolve claims that they violated the False Claims Act by submitting or causing the submission of false claims for payment to federal health care programs related to alleged medically unnecessary procedures performed by a gynecologic oncologist (‘the Doctor’)…
Ascension Michigan knowingly submitted false claims for payment to federal health care programs and improperly retained payment for professional and facility fees related to medically unnecessary radical hysterectomies that the Doctor performed, chemotherapy services that the Doctor administered or ordered that were not medically necessary, and evaluation and management services by the Doctor that were not performed or not rendered as represented.”

About the public’s health

Tennessee can enforce abortion waiting-period law, 6th Circuit rules: “The full 6th U.S. Circuit Court of Appeals, split largely along partisan lines, on Thursday revived a 2015 Tennessee law requiring a 48-hour waiting period for abortions, reversing a lower court decision blocking the law.
Circuit Judge Amul Thapar wrote in the 9-7 majority opinion that the law was constitutional because it did not place a ‘substantial obstacle’ in the way of a ‘large fraction’ of women seeking abortions before fetal viability.”

About healthcare IT

Allscripts Announces Second Quarter 2021 Results: “On a GAAP basis in the second quarter of 2021, income from operations was $10 million compared with a GAAP loss from operations in the second quarter of 2020 of $25 million. Non-GAAP income from operations in the second quarter of 2021 was $33 million compared with $25 million in the second quarter of 2020.”

About medical devices

llumina posts 78% revenue growth as cancer, DNA testing ramp back up: “Illumina’s sales (PDF) of consumables alone were up 82% year-over-year, totaling $704 million, with oncology testing showing three consecutive quarters of growth and the National Institute of Health’s All of Us program moving forward at full scale toward its goal of sequencing the genomes of at least one million people in the U.S.
About $189 million in Instrument sales set a new record, up 7% compared to the first quarter of this year, including about $20 million from COVID-19 tracking initiatives.”

Medtronic boosts ear, nose and throat portfolio with $1.1B bid for sinus implant maker Intersect ENT: “The medtech giant has set its sights on Intersect ENT, which has developed two types of steroid-eluting implants to treat cases of chronic rhinosinusitis, where symptoms like facial pain, pressure and nasal drainage or obstruction last for more than 12 weeks at a time, often requiring years of costly surgeries and other treatments.
Both companies’ boards of directors have approved the buyout, which will see Medtronic putting up $28.25 in cash for each of Intersect’s outstanding shares, pricing the transaction at about $1.1 billion.”

Today's News and Commentary

About Covid-19

Global COVID-19 cases surpass 200 mln as Delta variant spreads: “Coronavirus cases worldwide surpassed 200 million on Wednesday, according to a Reuters tally, as the more-infectious Delta variant threatens areas with low vaccination rates and strains healthcare systems.
The global surge in cases is highlighting the widening gap in inoculation rates between wealthy and poor nations. Cases are rising in about one-third of the world's countries, many of which have not even given half their population a first dose.”

Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19: “Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.”

Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19: “In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis.”

CDC: Delta variant accounts for 93 percent of all infections: “For the two-week period ending July 31, all the different lineages of the delta variant made up about 93 percent of cases that were sequenced.
In some parts of the country with low vaccination rates, especially the Midwest, the percentages are even higher.”

Moderna says its COVID-19 vaccine is 93% effective after 6 months, weaker against delta: “The new trial data was released just before an Aug. 5 earnings call. In the slides prepared for the call, Moderna said booster shots will most likely become necessary before winter to combat the rapid spread of the delta variant, which became widespread in the U.S. after the trial results were recorded.”

U.S. COVID-19 cases hit six-month high, Florida grapples with surge: “The United States hit a six-month high for new COVID cases with over 100,000 infections reported on Wednesday, according to a Reuters tally, as the Delta variant ravages areas where people did not get vaccinated.
The country is reporting over 94,819 cases on a seven-day average, a five-fold increase in less than a month, Reuters data through Wednesday showed. The seven-day average provides the most accurate picture of how fast cases are rising since some states only report infections once a week or only on weekdays.”

About health insurance

Biden Stimulus Increase Cut Obamacare Plan Premiums by 40%: “Average premiums for returning customers in the 36 states using the federal marketplace dropped from $104 a month to $62 a month, according to data from the Department of Health and Human Services.
The $1.9 trillion American Rescue Plan expanded the number of people eligible for subsidies for ACA marketplace coverage. It also bolstered the tax credits for those already purchasing coverage to make the plans more affordable.
For the first time it extended subsidies to people making more than 400% of the federal poverty level -- $106,000 for a family of four -- a group that had faced steep costs for insurance coverage. Their costs are now capped at 8.5% of income.
The expanded premium assistance is set to expire after 2022, but Democrats are seeking to extend it. The provision is projected to cost $34 billion, according to the Congressional Budget Office.”
The problem is not always premiums but the rapidly rising out-of-pocket expenses.

OIG audit targets Aetna's Medicare Advantage plans as government cracks down on fraud: “Federal regulators are auditing Medicare Advantage plans sold by CVS Health's payer arm Aetna as the government continues to crack down on inaccurate or fraudulent risk-adjustment scores in the program.
In a financial filing with the Securities and Exchange Commission on Wednesday, CVS disclosed HHS' Office of the Inspector General was looking at its MA business, amid a slew of recent whistleblower lawsuits and audits finding improper practices in the program.”

Cigna anticipates elevated claims costs for rest of 2021, execs say: “Cigna is bracing for elevated claims costs through the remainder of 2021, executives told investors Thursday morning.
Brian Evanko, Cigna's chief financial officer, said on the company's earnings call that costs associated with COVID-19 were higher than anticipated, and non-COVID utilization grew at a more rapid clip than was expected.”

Morgan Health Makes $50 Million Investment in Vera Whole Health: “Morgan Health, the JPMorgan Chase & Co. business focused on improving the quality, cost, and equity of employee healthcare, is investing in an innovative healthcare company that offers patients coordinated care and an enhanced primary care experience. Morgan Health announced today a $50 million investment in Vera Whole Health, its first investment in a coordinated care model.”

About hospitals and health systems

Public Payment Rates For Hospitals And The Potential For Consolidation-Induced Cost Shifting: “After controlling for many confounders, we found that hospitals with a higher share of Medicare patients had lower and more rapidly declining profits and an increased likelihood of closure or acquisition compared with hospitals that were less reliant on Medicare. This is consistent with the existence of consolidation-induced cost shifting and implies that reductions in public prices must be undertaken cautiously.”

About the public’s health

NRC Health 2021 Mid-Year Healthcare Consumer Trends Report: A few highlights:
”The good news is that the rate at which consumers are resuming services has risen by 5% from Q3 2020 to the first half of 2021. Not only is delayed healthcare decreasing…, many service lines and specialties are returning to normal levels, and… telemedicine and urgent-care visits are remaining the same. What’s interesting to note is that months before the pandemic, deferment rates were approaching a five-year low.
3 out of 4 consumers would choose a provider who shares prices over one who doesn't.

Moderna Gains Fast-Track Designation for mRNA-Based RSV Vaccine: “The FDA has granted Moderna Fast-Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than age 60.
Moderna’s RSV vaccine candidate uses the same lipid nanoparticle as the company’s authorized COVID-19 vaccine and contains optimized protein and nucleotide sequences.”

About healthcare IT

25 hospitals completing the most telehealth visits during the pandemic + what they charge: “Among all the hospitals offering telehealth, hospital outpatient clinic visits (CPT G0463) occurred the most, accounting for more than 47 percent of total telehealth claims.”
Interesting variation on charges across the country.
Note the CPT code is a temporary (G) code.

About pharma

Review of the FDA's Accelerated Approval Pathway: Form the HHS Office of the OIG: “The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway. In response to these concerns, we will assess how the FDA implements the accelerated approval pathway.”
The report is expected in 2023.

Bayer bets $1.5B that Vividion will help it target the 'undruggable' and make 1+1=3: Instead of a public offering, Vividion is partnering with Bayer and will retain R&D independence.

Today's News and Commentary

About Covid-19

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month: “President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had ‘taken an all-hands-on-deck approach’ to the work.”

Covid Live Updates: W.H.O. Calls for Moratorium on Covid Vaccine Boosters: “The World Health Organization called on Wednesday for a moratorium on coronavirus vaccine booster shots until the end of September to help all countries vaccinate at least 10 percent of their populations, appealing to the world’s wealthiest nations to address dramatic disparities in global vaccination rates.”

Who Can Make You Get a Covid Vaccine?: A really good review of the topic and what is currently being done.

Biden tells Florida, Texas leaders: Help on COVID-19 or 'get out of the way': Further information from the White House press conference reported here yesterday: “U.S. President Joe Biden on Tuesday urged Republican leaders in Florida and Texas - home to roughly a third of all new U.S. COVID-19 cases - to follow public health guidelines on the pandemic or ‘get out of the way’ as the country struggles to contain the rapid spread of the disease's Delta variant…
Florida Governor Ron DeSantis has opposed strict COVID-19 restrictions. On Friday, he issued an order blocking mask mandates in the state's schools. Texas Governor Greg Abbott issued an order last spring that would impose fines for mask mandates.”

Korea confirms first two cases of delta plus: “Delta plus is a sub-lineage of delta with an extra mutation in the spike protein called K417N -- the same mutation found in beta and gamma, variants of concern first spotted in South Africa and Brazil, respectively. South Africa stopped using AstraZeneca’s vaccine in February after a study showed it did not work well against the beta variant.”

After Nearly 9 Million Pfizer Shots for U.S. Teens, Serious Side Effects Rare: CDC: “As of July 16, close to 9 million teens, aged 12 to 17, had received the Pfizer-BioNTech vaccine — the only one okayed for that age group. Among roughly 9,240 reported side effects, 91% were minor, such as soreness near the vaccination site. 
But 9% were serious, with 4% developing a heart problem known as myocarditis…”

About healthcare quality

Mirror, Mirror 2021: Reflecting Poorly: Health Care in the U.S. Compared to Other High-Income Countries: From the Commonwealth Fund:

• “Key Findings: The top-performing countries overall are Norway, the Netherlands, and Australia. The United States ranks last overall, despite spending far more of its gross domestic product on health care. The U.S. ranks last on access to care, administrative efficiency, equity, and health care outcomes, but second on measures of care process.

• Conclusion: Four features distinguish top performing countries from the United States: 1) they provide for universal coverage and remove cost barriers; 2) they invest in primary care systems to ensure that high-value services are equitably available in all communities to all people; 3) they reduce administrative burdens that divert time, efforts, and spending from health improvement efforts; and 4) they invest in social services, especially for children and working-age adults.”

Differences in Cancer Care Expenditures and Utilization for Surgery by Hospital Type Among Patients With Private Insurance: A good example of the need to analyze methodology before assessing usefulness of a study’s findings.
“In this cross-sectional study, surgery at NCI centers vs community hospitals was associated with higher insurer spending for a surgical episode without differences in care utilization [length of stay, ED use, or hospital readmission within 90 days of discharge] patients with private insurance undergoing cancer surgery.” However…
”while every attempt was made to adjust for differences in case mix, our claims-based analysis did not allow for complete adjustment of clinical factors such as stage at diagnosis, surgical complexity, and pathologic status, which limited our ability to judge surgical quality.”
Further, longterm outcomes were not assessed.

Association Between the Physician Quality Score in the Merit-Based Incentive Payment System and Hospital Performance in Hospital Compare in the First Year of the Program: “Are higher scores on the Merit-Based Incentive Payment System (MIPS) for physicians associated with hospital-level patient outcomes?…
The MIPS quality score was not associated with the hospital composite rate of postoperative complications.”
Read the article for more information, the results for all surgical specialties are not straightforwardly uniform.

Majority of nursing homes missing broad safety, quality inspections due to the pandemic: “While the standard surveys, which check for quality and federal compliance, are required at least every 15 months, 71% of Centers for Medicare & Medicaid Services-certified nursing homes nationally had gone at least 16 months without one as of May 2021, according to a report from the Office of Inspector General.
Though it kept in place more narrow surveys such as infection control and targeted complaint investigations, CMS had suspended standard surveys due to the COVID-19 pandemic in March 2020. However, despite announcing in August 2020 that states should resume the surveys, resources allowing, the backlog grew from 8% in June of 2020 to 71%, the OIG’s latest examination of CMS administrative data found.”

About healthcare IT

FDA clears Abbott’s iPhone app for FreeStyle Libre 2: A reminder that such devices need FDA approval.

Envisioning a world of big, AI-ready—and free—healthcare data, a top medical school leads by example: “The academic medical institution that maintains the world’s best-stocked library of curated, patient-deidentified and AI-ready data is going 100% open source with its digital riches. 
Stanford Health announced…it already has nine available datasets containing more than 1 million useable assets—specifically annotated medical images—and is likely to hit 2 million within the next year.
As part of the expansion, the Center for Artificial Intelligence in Medicine and Imaging (AIMI) at Stanford University School of Medicine is partnering with Microsoft’s AI for Health program.”

About the public’s health

Effect of Graphic Warning Labels [GWL] on Cigarette Packs on US Smokers’ Cognitions and Smoking Behavior After 3 Months: “Although there was a significant increase in cognitions about quitting in the GWL group, there was no evidence of increased quitting or reduced consumption, and this was biochemically validated at the postintervention visit.”

About pharma

Amgen vows to fight after IRS demands $3.6B in back taxes—and a bigger bill could be on the way: “Amgen’s tax revelation came amid a mixed quarter for the drugmaker, which raked in $6.5 billion during the period. While that was a 5% increase compared with last year, the COVID-19 recovery has been gradual and will likely hit sales for the rest of the year, Amgen forecasted.”

About healthcare devices

Philips faces 2nd Class I recall in a month, this time for high-flow therapy ventilators: “At the core of the issue is a safety mechanism in the ventilators that caps the oxygen flow delivered to a patient and issues a low-priority alarm when the system reaches a default maximum pressure limit. A blockage to the flow of oxygen could raise the pressure, therefore triggering the safety cutoff and preventing the device from reaching the necessary level of oxygen flow.”

About health insurance

Aetna, CVS to enter ACA marketplace in 8 states: “The first Aetna CVS Health hybrid-branded product will be available in Arizona, Florida, Georgia, Missouri, Nevada, North Carolina, Virginia and Texas, according to a series of Aug. 4 news releases, and confirmed by a CVS spokesperson.”

CVS Health sees profit dip to $2.8B in Q2: “While profits are down slightly compared to the second quarter of 2020, the company is still on par for the first half of the year, bringing in $5 billion in profit. It also reported $5 billion in profit for the first half of 2020.”

Nationwide out-of-pocket spending jumped 10% in 2021. Expect that growth to continue through 2026: “Consumer out-of-pocket spending on healthcare is set to hit an estimated $491.6 billion, or about $1,650 per person, in the U.S., according to a recent report.
The number is a roughly 10% increase over last year’s total and is expected to maintain a continual annual growth rate of 9.9% for the next five years…”

About hospitals and health systems

Hospitals with higher credit ratings weathered greater margin deterioration, Fitch says: “In contrast, hospitals with ‘BBB’ ratings below investment grade categories saw incremental improvements in operating margins. 
Fitch said hospitals with lower ratings likely saw some improvement for several reasons, including that many took immediate expense reduction efforts and recognized stimulus funding quickly. Fitch also said the smaller sample size may have contributed.”

CMS' final inpatient payment rule for 2022: 7 things to know: A good summary of the rule.

MUSC wraps up purchase of 3 South Carolina hospitals from LifePoint Health: The headline is the story.

Today's News and Commentary

3 key health policies in the Senate's $1T infrastructure package:

• “Providers got a win in the package when lawmakers agreed to not raid unallocated COVID-19 Provider Relief Fund monies. However, the legislation does deal a blow to the industry’s efforts to halt a 2% cut to Medicare payments from resuming.

• Requiring drugmakers to refund Medicare for any discarded drugs
  The requirement applies to drugs dispensed under Medicare Part B, which reimburses for drugs administered in a doctor’s office such as chemotherapy. The requirement applies to single-dose containers or single-use package drugs.

• The legislation demands that any federal contract to buy PPE must be for two years and go to a domestic manufacturer. The two-year time frame will give the domestic PPE maker enough financial security to stay in the market.”

2021's Best & Worst States for Health Care: WalletHub’s annual ranking based on Cost, Access and Outcomes. [The classic triad of cost/quality/access]. Massachusetts, RI and Minnesota are the top 3; Arkansas, Louisiana and Alabama [lowest] are at the bottom. The various measures are worth a look.

About devices

FDA Regulation and Approval of Medical Devices: 1976-2020: A good review of the topic, highlighted by a concise timeline of regulatory actions.

About Covid-19

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials: Transcript of yesterday’s press conference. A great summary of what is happening with Covid-19.

Don’t Want a Vaccine? Be Prepared to Pay More for Insurance.: The Federal government requires waiver of out of pocket expenses for Covid-19 testing and vaccination, but not treatment. This policy raises the question of who pays for treatment if the vast majority (97%) of hospitalizations are non-vaccinated persons. Will/should health plans charge higher premiums and fees to those who refuse the vaccine? Can it apply to anyone who is unvaccinated for other diseases- like influenza, pertussis, and pneumococcal vaccines?

US hits 70% vaccination rate -- a month late, amid a surge: “The U.S. on Monday finally reached President Joe Biden’s goal of getting at least one COVID-19 shot into 70% of American adults -- a month late and amid a fierce surge by the delta variant that is swamping hospitals and leading to new mask rules and mandatory vaccinations around the country.”

NYC Becomes Largest U.S. City To Require Proof Of Vaccination For Indoor Activities: “New York City will require workers and patrons at indoor businesses to show proof of vaccination starting on Sept. 13, becoming the first major U.S. city to take such action amid a surge of new cases nationwide driven by the highly transmissible delta variant.
The new mandate announced Tuesday, dubbed the ‘Key to NYC Pass,’ will apply to indoor dining, gyms and entertainment venues.”

Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains: The conclusion of this simulation was that masking must be done with aggressive vaccination. The reason is that viral transmission from vaccinated persons gives the virus a chance to mutate.

11 bans on vaccine mandates — What states have them & which might soon: A good summary.

Germany Will Offer Vaccine Booster Shots Starting in September: “As concerns grow over the highly contagious Delta variant of the coronavirus, Germany on Monday became the biggest Western country yet to announce that it will offer vaccine booster shots to a wide range of people considered potentially vulnerable, adding to growing momentum in rich nations to give additional shots to fully vaccinated people.
The move by Germany came even as a top European Union official criticized the bloc as falling far short of its promises to donate vaccine doses to Africa and Latin America. And with a limited global vaccine supply, health experts say the top priorities should be distributing doses to poor countries that lag far behind in inoculations, and persuading vaccine-resistant people in wealthy countries to get their first shots.”

Insurer filings suggest COVID-19 pandemic will not drive health spending in 2022: “Of the 75 insurer filings submitted in these states [13 states and DC], only 13 say the COVID-19 pandemic will have an upward effect on their costs, with most of those stating that the impact would be less than 1%. This includes seven plans in New York, three plans in Connecticut, one plan in Tennessee, one plan in Michigan, and one plan in Vermont. Three insurer filings said the pandemic would have a downward impact on their costs. About half (37 insurers) say the pandemic will have no net impact on their 2022 costs. The remaining insurers either did not specify a COVID-19 cost impact or redacted it.  
Among the 13 plans that specified cost increases due to COVID, reasons included costs related to ongoing COVID-19 testing, treatment, and vaccinations (8 insurer filings), and anticipated vaccination boosters (7 insurer filings).”

Eli Lilly's COVID-19 antibody sales crater as variants, vaccines take a toll: “Lilly’s COVID-19 antibodies raked in $148.9 million during the quarter, an 82% drop from the $810.1 million the drugs generated during the first quarter this year. That includes sales of bamlanivimab, plus Lilly’s combo treatment that pairs that drug with etesevimab. 
Neither of Lilly’s treatments, however, are being deployed in the U.S. amid the rapid rise of variants. In early April, the FDA revoked its authorization for bamlanivimab alone after the mutations proved resistant to the solo treatment.”

About healthcare IT

4.5 million affected by data breaches in July: 10 hospitals hit: Why people don’t trust the healthcare system to keep records safe: “In July, 4,584,411 patients and employees across 39 healthcare organizations were hit by data breaches.”

A COVID-19 Telehealth Impact Study—Exploring One Year of Telehealth Experimentation: A good of telehealth utilization, reasons for use and satisfaction through December 2020. The standout is use of behavioral health.

Modernizing Public Health Data SystemsLessons From the Health Information Technology for Economic and Clinical Health (HITECH) Act: Some recommendations from Google- worth a quick read.

About hospitals and health systems

CMS finalizes $2.3B pay bump for hospitals in federal fiscal 2022: “The Biden administration has finalized a rule that gives hospitals an overall $2.3 billion for the 2022 fiscal year that begins in October and scraps a proposal for hospitals to disclose Medicare Advantage rates. 
The final Hospital Inpatient Prospective Payment Services rule, released Monday by the Centers for Medicare & Medicaid Services (CMS), also includes a 1.1% hike for long-term care hospitals. The regulation also extends an add-on payment for new COVID-19 treatments through the end of the fiscal year where the public health emergency ends and requires hospitals to submit data on several public health measures to identify emerging outbreaks.”

Three notices of system sales:
HCA sells 4 hospitals to Piedmont
Ascension sells 7 Wisconsin hospitals, 21 clinics
Tenet sells 5 Florida hospitals

National Hospital Flash Report: Monthly report from KauffmanHall. Read the repot for details. Overall: “While overall metrics indicate continued recovery for hospitals and health systems nationwide, the uptick in COVID-19 cases could hinder progress in the coming months.”

About pharma

Quantifying The Economic Burden Of Drug Utilization Management On Payers, Manufacturers, Physicians, And Patients: “Based on a compilation and analysis of the existing peer-reviewed and professional literature, this article estimates that payers, manufacturers, physicians, and patients together incur approximately $93.3 billion in costs annually on implementing, contesting, and navigating utilization management. Payers spend approximately $6.0 billion annually administering drug utilization management, and manufacturers spend approximately $24.8 billion supporting patient access in response. Physicians devote approximately $26.7 billion in time spent navigating utilization management, whereas patients spend approximately $35.8 billion annually in drug cost sharing, even after taking advantage of manufacturer and philanthropic sources of financial support.”

Sanofi to buy partner Translate Bio for $3.2bn in mRNA push: “French pharmaceutical group Sanofi will acquire its partner Translate Bio for $3.2bn, as it makes a big bet on the future of messenger RNA as a transformative technology for vaccines and therapeutics.”

Today's News and Commentary

About COVID-19

U.S. CDC chief says there will be no federal mandate on COVID-19 vaccine: “U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said on Friday there will be no nationwide mandate for Americans to get a COVID-19 vaccine, clarifying comments she made earlier during a televised interview.”

FDA vows ‘all hands on deck’ effort to get Pfizer coronavirus vaccine full approval as quickly as possible: “With coronavirus cases surging, the Food and Drug Administration’s top vaccine official said Friday the agency is redeploying staff and adding computer and other technical resources to accelerate an effort to grant the Pfizer coronavirus vaccine full approval as rapidly as possible.
‘We have rolled out an all hands on deck’ strategy to identify ways to expedite approval of the vaccine, which is currently being administered under the FDA’s emergency use authority, said Peter Marks, director of the Center for Biologics Evaluation and Research, in an interview.”

About pharma

FTC drops antitrust case against AbbVie, but still decries the company's 'ill-gotten gains': “Appealing a $448 million judgement in an antitrust case has ultimately paid off for AbbVie.
On Friday, the U.S. Federal Trade Commission withdrew its complaint that AbbVie (then under the umbrella of Abbott Laboratories) used sham litigation in 2011 to illegally block generic competition for its testosterone drug AndroGel. While the agency still thinks AbbVie engaged in ‘anticompetitive conduct,’ an official said current laws don't support the agency's efforts to recoup money for consumers.”

The Top 10 Most Expensive Popular Generic Drugs in the US (and How to Save): From Good Rx. Two of the top 10 are erectile dysfunction drugs.

FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway: “Since the US Food and Drug Administration established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found.
Of these 112 drugs approved in the past 28 years, a fifth (24) have been on the market for more than five years and some for more than two decades—often with a hefty price tag, shows an in-depth analysis of FDA data to 31 December 2020, conducted by The BMJ.
The accelerated pathway allows drugs onto the market before efficacy has been proved. As part of this approval, however, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to ‘verify the anticipated clinical benefit.’ If these trials show no benefit the drug’s approval can be cancelled.
Further analysis of FDA data shows that only 16 drugs approved through the pathway have ever been withdrawn. Most of these were shown to lack efficacy, but in some cases the confirmatory trials were never done. Celecoxib (Celebrex), which was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because the efficacy trials were never done.”

About health insurance

DOJ joins false claims suit against Kaiser Permanente: “According to the lawsuits, Kaiser Permanente pressured its physicians to include addenda on patient records to additional diagnoses. These updates were at times made months or more than a year later, for conditions the patient did not have or that were not considered at the time of their visit, the DOJ said.
The false claims allegations were initially filed in a series of whistleblower suits, the DOJ said.”

NPs get prison time for telemedicine fraud: “Two nurse practitioners have been sentenced to prison and ordered to pay restitution for conspiring to defraud Medicare, the U.S. Justice Department announced July 30. 
Janae Harper, NP, 34, of Kalispell, Mont., was sentenced to 12 months in prison and ordered to pay $4.3 million in restitution. Mark Hill, NP, 54, of Edinburg, N.D., received a nine-month prison sentence and was ordered to pay $5.1 million in restitution. The sentences were handed down after both defendants pleaded guilty to conspiracy to commit healthcare fraud. 
The government alleged Ms. Harper worked with staffing and telemedicine companies to commit healthcare fraud from late 2017 through July 2019. She allegedly received money to sign brace orders that were prepared by telemarketers who had no medical training. She allegedly signed 7,673 brace orders, which resulted in $8.3 million billed to Medicare, according to the Justice Department. 
The government alleged Mr. Hill also worked with telemedicine and staffing companies to commit fraud. He was allegedly paid to sign brace orders for Medicare beneficiaries from October 2017 through April 2019. He allegedly signed 7,097 brace orders, which resulted in $10.1 million billed to Medicare.”

Today's News and Commentary

About Covid-19

Americans are afraid their vaccine passports could be hacked: ”A new Harris Poll reveals that 80% of Americans are worried that getting a COVID-19 digital passport could put their personal data at risk.
Among the majority of Americans who have cybersecurity concerns about the new digital vaccine credentials, the survey found that slightly more than half were uneasy about the potential for identity theft. On top of that, less than half of Americans believe that either businesses or the government are prepared to defend passport apps against a potential cyber attack.”

U.S. FDA allows Lilly's COVID-19 drug to be taken without remdesivir: “The U.S. health regulator expanded the emergency use authorization for Eli Lilly’s COVID-19 drug baricitinib, saying it could now be used without taking Gilead’s drug remdesivir along with it, Lilly said on Thursday.
In November, the U.S. Food and Drug Administration (FDA) approved Lilly and Incyte’s arthritis drug, baricitinib, in combination with remdesivir, to treat COVID-19 patients.”

‘The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe: The Washington Post obtained this internal CDC document. “The data and studies cited in the document played a key role in revamped recommendations that call for everyone — vaccinated or not — to wear masks indoors in public settings in certain circumstances, a federal health official said. That official told The Post that the data will be published in full on Friday. CDC Director Rochelle Walensky privately briefed members of Congress on Thursday, drawing on much of the material in the document.”

CDC study shows three-fourths of people infected in Massachusetts covid-19 outbreak were vaccinated: “Critically, the study found that vaccinated individuals carried as much virus in their noses as unvaccinated individuals, and that vaccinated people could spread the virus to each other. The CDC was criticized this week for changing its mask guidance without citing unpublished data. The report released Friday contains that data.”

Physicians who post COVID-19 vaccine misinformation may lose license, medical panel says: “The Federation of State Medical Boards warned July 29 that physicians and other healthcare professionals could be at risk of losing their medical licenses if they spread COVID-19 vaccine misinformation on social media, online and in the media. 
FSMB, a nonprofit that represents all U.S. state medical boards, said any clinicians who create or spread vaccine misinformation or disinformation risk disciplinary action by state medical boards, including suspension or revocation of their medical license.”

Marshfield Clinic lab plays vital role in CDC’s COVID-19 effort: “History books written about the COVID-19 pandemic won’t be complete unless they mention the pivotal role played by the Marshfield Clinic Research Institute, which is part of Wisconsin’s Marshfield Clinic Health System. The institute’s scientists test and process some 10,000 swabs a week, helping the Centers for Disease Control and Prevention (CDC) both track the progression of the disease and prove the effectiveness of the mRNA vaccines…
The lab has built a national reputation as a leader in respiratory infectious disease research through its participation in the flu vaccine effectiveness network and its collaboration with the CDC during the H1N1 flu pandemic of 2009—which some describe as the ‘dress rehearsal’ for the COVID-19 pandemic…”

About health insurance

Insurers push back on CMS' proposals to extend ACA open enrollment, bring back standardized plans: “Insurers pushed back at the Biden administration’s efforts to extend the Affordable Care Act’s open enrollment period by another month and require them to post standardized plan options.
Several insurers and advocacy groups commented on the proposals outlined in the Centers for Medicare & Medicaid Services’ Notice of Benefit and Payment Parameters, which outlines ACA marketplace exchange regulations for the 2022 coverage year. Insurers worried that extending the open enrollment period could lead to adverse selection and raise premiums for consumers.”

CMS: Part D premiums projected to increase nearly 5% in 2022 to $33: “The average Part D premium is projected to increase by nearly 5% from $31.47 to $33 in 2022.
Thursday’s announcement comes as Congress and the Centers for Medicare & Medicaid Services are making moves to address drug prices on Part D, the program’s prescription drug benefit.”

CMS releases 4 final payment rules: 16 things to know: “CMS on July 29 released its annual final payment rules for hospices, inpatient psychiatric facilities, inpatient rehabilitation facilities and skilled nursing facilities.” This article is a good summary. Here is the CMS statement.

Medicare Advantage:Beneficiary Disenrollments to Fee-for-Service in Last Year of Life Increase Medicare Spending: From the GAO: “We found that Medicare Advantage beneficiaries in the last year of life disproportionately disenrolled to enroll in fee-for-service, indicating possible issues with their care. Shifting end-of-life costs to fee-for-service increased Medicare spending by hundreds of millions of dollars.
We recommended monitoring end-of-life Medicare Advantage disenrollments to identify and address potential quality of care concerns.”

New bill aims to boost Medicare access to chronic care services: ”New legislation aims to eliminate the cost-sharing requirement for Medicare beneficiaries to get chronic care management services and reimburse providers for 100% of the payment.
The legislation, reintroduced Thursday, intends to boost access among seniors to chronic care management services that include creating a care plan and medication reconciliation and adherence.”

About pharma

Kaiser health plan files 'pay for delay' suit against Merck over cholesterol drugs: “Kaiser Foundation Health Plan's suit claims that the insurer paid hundreds of millions more for cholesterol drugs Zetia and Vytorin because the companies agreed to delay the launch of generic competitors…
The lawsuit is the latest challenge to so-call ‘pay for delay’ arrangements, which allow drugmakers to extend the length of their patent monopolies on certain pharmaceuticals. Pharma companies argue these arrangements are critical to allowing them to recoup research and development costs.” And in a related story:
Senate takes aim at pharma's patent schemes, pay-for-delay deals in renewed drug pricing crackdown: On Thursday the Senate Judiciary Committee “voted unanimously to advance four pieces of legislation which would help rein in the cost of prescription drugs.
The new laws take particular aim at the tactics used by drug companies to extend patent protections and stifle competition from cheaper generic and biosimilar drugs. The legislation, which would enhance the Federal Trade Commission's ability to initiate enforcement actions against drug companies, now moves to the Senate floor for a vote.”

AbbVie posts new data on drug that could replace glasses or contacts for age-related far-sightedness: “AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for age-related far-sightedness, which is typically treated with contacts or glasses.
The study of AGN-190584, or pilocarpine formulation, showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing.”
This article provides a great case study for marketing a new therapeutic alternative. What about people who like to make a “fashion statement” with their glasses?

Prothena rolls out preclinical data for anti-amyloid Alzheimer's candidate to rival Biogen's Aduhelm: “In preclinical data presented Monday, Prothena said its fully humanized antibody targeting the N-terminus of amyloid-beta achieved greater avidity, or binding, than Aduhelm. The preclinical data showed the antibody could clear two main types of amyloid-beta plaque in the brain…
With its stronger binding potential, PRX012 may be able to be delivered at a lower dose and be administered subcutaneously [compared to Aduhelm which is given intravenously]…
Pricing information was not supplied.

Creditors Show Support for Purdue Pharma’s Bankruptcy Plan: “If preliminary voting sticks, Purdue Pharma’s controversial bankruptcy plan that settles with thousands of cities and states over the company’s role in the opioid epidemic will be accepted when the final tally is made public Aug. 2.
More than 95 percent of the 120,000-plus votes submitted are in favor of the bankruptcy proposal and nearly 97 percent of almost 5,000 state and local governmental creditors voted to accept the plan, the company said.”

AstraZeneca ups annual forecast following Alexion purchase: Details are in the article.

About healthcare devices

FDA dishes out Class I label to Philips' recall of faulty CPAP machines and other ventilators: “A recall of Philips’ ventilators for at-home and clinical use was given the FDA’s most serious classification after the devices were found to put users at risk of inhaling or swallowing dangerous pieces of debris.
The FDA handed down its Class I label several weeks after Philips initiated the recall in mid-June. Patients and healthcare providers using the company’s continuous and non-continuous ventilators—including CPAP and BiPAP machines to treat sleep apnea—are urged to stop using the devices immediately and contact Philips to replace the component.
At the root of the issue is the polyester-based polyurethane foam built into Philips’ ventilators to help reduce sound and vibrations. Over time the foam can potentially break down, sending specks of black debris and dangerous chemicals into the air pathway.”

Prescient Imaging Gains 510(k) Clearance for Portable PET Scanner: A real point-of-care breakthrough: “Hawthorne, Calif.-based Prescient Imaging has received 510(k) clearance from the FDA for its portable positron emission tomography (PET) scanner BBX-PET.
The device, which can be wheeled to the point of care, is cleared for obtaining PET images of parts of the human body, including the head. Potential uses include scans in neurology, geriatric psychiatry and radiation oncology centers.”

About healthcare IT

447,000 patients exposed after phishing attack on Florida practice: “Orlando (Fla.) Family Physicians began notifying 447,426 patients that it was the victim of a phishing attack on its employee email accounts…
Exposed data may include names, health insurance information, Social Security numbers, passport numbers and medical-related information.”
The attack targeted email accounts of several employees.

IU Health launches 'hack' lab to test medical device security: At Indiana University a “new lab is testing the cybersecurity of about 15 devices, including anesthesia and electrocardiogram machines, infusion pumps and patient monitors. The security team is essentially trying to hack the devices…“

Today's News and Commentary

About Covid-19

The C.D.C. now says fully vaccinated people should get tested after exposure even if they don’t show symptoms.: “‘Our updated guidance recommends vaccinated people get tested upon exposure regardless of symptoms,’ Dr. Rochelle P. Walensky, the agency’s director, said in an email to The New York Times…
Fully vaccinated people should wear a mask in public indoor spaces after exposure, the agency said. Three to five days later, they should be tested for the virus.
If the results come back negative, they can stop wearing masks indoors. If results are positive, the infected should isolate at home for 10 days.”

Bipartisan Senate infrastructure deal will not touch COVID-19 relief funds but delays Part D rebate rule: “A bipartisan group of senators announced an agreement on major pieces of the roughly $1 trillion infrastructure package. The deal will not touch COVID-19 provider relief funds to help pay for the package. However, in a major win for pharmacy benefit managers, it will delay a rule to get rid of the safe harbor for Part D rebates…”

J&J says U.S. FDA agrees to extend shelf life of its COVID-19 vaccine: “The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson's single-shot COVID-19 vaccine to six months from four-and-a-half months, the company said late Wednesday.”

White House tells agencies to mandate masks in federal buildings in hot spots: “Numerous U.S. federal agencies on Wednesday mandated masks at federal buildings in COVID-19 hot spots in line with instructions issued by the White House Office of Management and Budget (OMB), according to an OMB email seen by Reuters.
The move followed guidance issued by the Centers for Disease Control and Prevention (CDC) on Tuesday that vaccinated people should wear masks indoors in areas with substantial or high COVID-19 community transmission.
The White House said masks are required indoors in federal buildings for all employees and visitors, whether or not vaccinated, in those areas.”

Covid-19 Breakthrough Infections in Vaccinated Health Care Workers: “Among 1497 fully vaccinated health care workers for whom RT-PCR data were available, 39 SARS-CoV-2 breakthrough infections were documented. Neutralizing antibody titers in case patients during the peri-infection period were lower than those in matched uninfected controls… Higher peri-infection neutralizing antibody titers were associated with lower infectivity…Most breakthrough cases were mild or asymptomatic, although 19% had persistent symptoms (>6 weeks). The B.1.1.7 (alpha) variant was found in 85% of samples tested…No secondary infections were documented.”

About pharma

FDA Approves First Interchangeable Biosimilar Insulin: “The US Food and Drug Administration (FDA) has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.
The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.”

Children’s Hospital of Philadelphia Researchers Develop “Dimmer Switch” to Help Control Gene Therapy: This discovery could have a huge impact on and create the next generation for gene therapies:
”In a major advancement in the field of gene therapy for rare and devastating diseases, researchers at Children’s Hospital of Philadelphia (CHOP) have developed a ‘dimmer switch’ system that can control levels of proteins expressed from gene therapy vectors. The system is based on alternative RNA splicing using an orally available small molecule and works effectively in tissues throughout the body, including the brain. The first research regarding this innovation was published today in the journal Nature.”

Eli Lilly bets $70M upfront and another $2B in biobucks for Kumquat's immuno-oncology small molecules: “The deal sees Lilly partner with Kumquat—run by a pair of serial entrepreneurs—to develop small molecules that stimulate tumor-specific immune responses, according to a statement. In return for the upfront payment, which consists of a cash payment and an equity investment, Lilly secures an option to a ‘certain number’ of drug candidates.”

July 2021 Pharmacy Market Outlook: Worth a quick read…the “bottom line” on cost is that the total weighted average drug price inflation estimate for 2022 is 3.10%.

About health insurance

Sign-Up Window for Free COBRA Coverage for Many Laid-Off Workers Closes This Week: “Under the American Rescue Plan Act that President Joe Biden signed in March, COBRA premiums for laid-off workers are covered in full by federal funding for six months from April through September…
For people… who lost their jobs before April 1, the window to take advantage of the subsidized coverage is closing. They have 60 days from the date their employer notified them of the COBRA subsidy to sign up for it — that’s July 31 if their employer notified them at the end of May. People notified earlier may have already missed their opportunity.”

About healthcare IT

Most Americans Want to Share and Access More Digital Health Data: One of the biggest impediments to interoperability has been peoples’ reluctance to have a unique identifier. According to this Pew Foundation survey, this sentiment has changed: “By a roughly 2-to-1 margin, respondents were comfortable with their health providers scanning patient fingerprints or assigning individuals a unique number or code to ensure that different EHR systems correctly match records for the same person, a long-standing challenge of data exchange.”

Parent of 1,000-physician network acquires digital health firm: The trend of cross-functional healthcare organizations’ consolidation continues: “The parent company of Catalyst Health Network, a 1,000-physician network based in Plano, Texas, acquired digital health company MediBookr, according to a July 27 news release.”

About hospitals and health systems

14 hospitals, systems sue HHS over graduate medical education payments: A group of 14 hospitals and health systems, including Michigan Medicine in Ann Arbor and Hospital for Special Surgery in New York City, is suing HHS over a calculation used to determine payments for physician training programs, according to court documents.
In the July 26 lawsuit, the hospitals claim they have been underpaid for several years due to a regulation implemented by HHS.
The regulation at the center of the lawsuit changed the weight assigned to full-time equivalent residents and fellows in the calculation to determine direct graduate medical education payments. Under the regulation, if a resident's training time exceeds the number of years designated as the "initial residency period," the resident's time is weighted at 0.5. Additionally, the regulation established a cap on the number of full-time equivalents that a hospital may claim in a given fiscal year.”

Today's News and Commentary

About Covid-19

PPE is designed for men. Some health experts are hoping to change that.: “Research conducted last year in the United Kingdom revealed respiratory equipment “poorly fit” 16.7% of female health workers compared to 7.6% of men. PPE — including gloves, goggles, face masks, visors, or protective suits — that doesn’t fit properly leaves users exposed to harmful substances or chemicals as well as infections.”

COVID vaccines have higher approval in less-affluent countries: “The analysis, reported on 16 July in Nature Medicine, found that 80% of individuals surveyed in ten low- and middle-income countries (LMICs) in Asia, Africa and South America were willing to receive a COVID-19 vaccine, compared with 65% in the United States. Upper-middle-income Russia is an outlier: only 30% of people there were willing to have the jab.”
So…which countries are more “developed”?

Estimating SARS-CoV-2 infections from deaths, confirmed cases, tests, and random surveys: “The extent of the virus’ spread remains uncertain due to biases in test data. We combine multiple data sources to estimate the true number of infections in all US states. These data include representative random testing surveys from Indiana and Ohio, which provide potentially unbiased prevalence estimates. We find that approximately 60% of infections have gone unreported. Even so, only about 20% of the United States had been infected as of early March 2021, suggesting that the country was far from herd immunity at that point.”

3rd Pfizer dose strongly protects against delta variant, data shows: “In slides the drugmaker posted ahead of an earnings call, Pfizer showed data that antibody levels against the delta variant were five times higher in people aged 18 to 55 after a third dose and 11 times higher in 65- to 85-year-olds.”

About the public’s health

The information keeps coming in regarding helpful and deleterious effects of dietary behavior. In the end, we are still left left with the ancient wisdom: παν μέτρον άριστον- everything in moderation.
Moderate drinking linked to lower heart attack risk, study says: “Drinking a bottle or two of wine a week may be associated with decreased risk of heart attack, stroke, angina or death among those with cardiovascular disease, according to a study published Monday in BMC Medicine.
Researchers found that people who drink up to 105 grams of alcohol per week -- roughly six to eight drinks -- had lower risks of heart problems than those who didn't drink.”

New study finds drinking too much coffee can shrink your brain, increase dementia risk significantly: “…participants who consumed more than six cups of coffee each day had a 53-percent increased risk of dementia and smaller total brain volumes.”
However, last month, this article concluded: “New studies show why coffee is so beneficial for your health: “A new study finds that drinking three to five cups of coffee daily is associated with a reduced risk of several chronic diseases.”

Seqirus says it can supply 60 mln doses of influenza vaccines for U.S. flu season: “Vaccine maker Seqirus, a part of Australia-based biotech company CSL Ltd, said on Tuesday it has started shipping its influenza vaccines to the United States and can supply about 60 million doses of its shots for the upcoming flu season.”
Predications about the prevalent strain may be tricky this year since rates of influenza have been very low due to isolation/prevention measures that Covid-19 prompted.

About pharma

Remember when Harvoni and Sovaldi entered the Hepatitis C treatment market at a list price of $84,000 for a single course of treatment? This article explains a 97% efficacious treatment that costs $100:
From US$84,000 to US$100: Malaysia a step closer to eliminating hepatitis C with new, affordable drug: “The development of Ravidasvir was initiated by Malaysia’s Ministry of Health and the Geneva-based Drugs for Neglected Diseases initiative (DNDi). The clinical studies were funded by Malaysian and Thailand health authorities, as well as other agencies, companies and organisations.”
Again, we should ask the question: Which countries are more “developed”?

J.D. Power: Number of patients seeking health, wellness services at pharmacies on the rise: “J.D. Power released its 2021 U.S. Pharmacy Study on Wednesday, where it found that 51% of customers at retail pharmacies used health and wellness services in the past year.
By comparison, 48% said the same in 2020's report and 43% said they used such services in 2019, J.D. Power said.”
This growth has significance for public health (delivery of vaccines, health messages, etc.) but also as an important marketing channel.

These two stories are opposite ends of the same issue- pharma companies covering patients’ out-of-pocket expenses so those firms can charge insurers high prices.
Humana follows federal footsteps, sues Regeneron over Eylea pricing: “Humana is right behind the federal government in suing Regeneron for allegedly inflating its macular degeneration drug, Eylea, and using a ‘sham’ charity to pay out kickbacks to cover cost-sharing obligations, according to the lawsuit. 
Filed July 22, the Humana lawsuit is strikingly similar to accusations coming out of the U.S. Attorney for the District of Massachusetts in 2020, which alleged that Regeneron paid tens of millions of dollars in kickbacks for Eylea. This was largely done through making donations to a third-party foundation that would ensure the money went exclusively toward Eylea copays.
Humana's lawsuit notes the insurer has paid out over $900 million in claims for Eylea, so it is seeking upward of $2.7 billion in damages.”
Pfizer court fight could legalize Medicare copays and unleash ‘gold rush’ in sales: “Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.”

About medical devices

Boston Scientific tops expectations with 53% sales growth over 2020: “The company posted net sales of about $3.08 billion for the second quarter of 2021, or a 53.6% gain over the same three months of the year before, when the first major wave of COVID-19 swept through the U.S.
Each of Boston Scientific’s three main business segments increased their revenues by more than half. Medical and surgical tools, including endoscopy and urology devices, delivered $948 million and 64.6% growth; meanwhile, heart rhythm, electrophysiology and neuromodulation hardware topped $866 million, an increase of 65%. 
Finally, the company’s cardiovascular division brought in $1.26 billion, a 51.4% boost over 2020’s second quarter—which, when adding up all three segments, only amounted to about $2 billion total.”

About health insurance

Humana boosts guidance as it posts $588M in Q2 profit: “Humana brought in $588 million in profit for the second quarter of 2021, down 67.8% from its haul in the prior-year quarter.
This echoes its peers' quarterly performance. Insurers posted sky-high profits in the second quarter of 2020 as healthcare utilization plummeted under the pandemic, raking in so much cash that Congress began a probe of their finances.”

Physician, wife indicted in connection with Medicare billing scam: “According to the indictment, the couple collected genetic samples from Medicare patients and sent them to clinical laboratories in exchange for kickbacks of up to $5,000. The employees collected DNA swabs for these tests, for which they received payment. 
The tests were not conducted by necessity… Medicare was billed over $1.3 million for the tests.”

About healthcare quality

Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction [HFrEF]: Not all good ideas work: “Among patients with HFrEF in hospitals randomized to a hospital and postdischarge quality improvement intervention vs usual care, there was no significant difference in time to first heart failure rehospitalization or death, or in change in a composite heart failure quality-of-care score.”

Using Consistently Low Performance to Identify Low-Quality Physician Groups: “A subset of physician groups that was consistently low performing could be identified by considering performance measures across multiple years. Considering the consistency of group performance could contribute a novel method to identify physician groups most likely to benefit from limited resources.”

Prevalence, Cost, and Variation in Cost in US Children’s Hospitals: “This cohort study found that major depressive disorder, scoliosis, acute appendicitis with peritonitis, asthma, and dehydration were high in prevalence, costs, and variation in cost. These results could help identify where future comparative effectiveness research in hospital pediatrics should be targeted to improve the care and outcomes of hospitalized children.”

About healthcare IT

Teladoc stock tumbles on growing losses as telehealth giant expects deficits to continue: “The wider losses were due to expenses related to the large-scale acquisition of Livongo and InTouch Health. ‘The larger net loss was primarily attributable to increased stock-based compensation,’ Chief Financial Officer Mala Murthy said during the company's second-quarter earnings call Tuesday.
The company saw continued improvement with its adjusted earnings before interest, taxes, depreciation, and amortization, or EBITDA, which came in at $67 million for the quarter compared to $26 million a year ago and ahead of consensus estimates at $62.9 million…”

IBM Report: Cost of a Data Breach Hits Record High During Pandemic: “Industries that faced huge operational changes during the pandemic (healthcare, retail, hospitality, and consumer manufacturing/distribution) also experienced a substantial increase in data breach costs year over year. Healthcare breaches cost the most by far, at $9.23 million per incident – a $2 million increase over the previous year.”

Apple Watch’s data ‘black box’ poses research problems: “A Harvard biostatistician is rethinking plans to use Apple Watches as part of a research study after finding inconsistencies in the heart rate variability data collected by the devices. He found that the data collected during the same time period appeared to change without warning.”

Today's News and Commentary

About Covid-19

CDC urges vaccinated people in high-transmission areas to resume wearing masks indoors as delta variant spreads: “The agency advised that vaccinated people who live in high-transmission places wear masks in indoor public spaces, according to three people familiar with the guidance. It also recommended that vaccinated people with vulnerable household members, including young children and those who are immunocompromised, wear masks indoors in public spaces.
The agency also called for universal masking for all teachers, staff members and students in schools, regardless of their vaccination status.”

Moderna says it plans to expand Covid vaccine trial for kids 5 to 11, will seek FDA OK as early as year-end: “The U.S. drugmaker is expanding the trial, which began in late March, to increase the likelihood of detecting potential rare side effects, the company said, declining to say how many children it ultimately hopes to enroll.”

Safety Evaluation of the Second Dose of Messenger RNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose: “This multisite US study supports the safety of Pfizer-BioNTech or Moderna vaccine second dose administration in patients who report immediate and potentially allergic reactions after the first dose. Although mild symptoms were reported in 20% of patients with second dose administration, all patients who received a second dose safely completed their vaccination series and could use mRNA COVID-19 vaccines in the future when indicated.”

About healthcare IT

Epic pays hospitals that use its EHR algorithms, report finds: ”Verona, Wis.-based EHR giant Epic gives financial incentives to hospitals and health systems that use its artificial intelligence algorithms, which can provide false predictions, according to a July 26 STAT News investigation. 
For its report, STAT interviewed several health systems that use any of Epic's 20 algorithms. Employees of several major systems told the publication they were concerned about Epic's algorithm for predicting sepsis, claiming that the tool routinely fails to identify the condition in advance and frequently triggers false alarms, according to the report. Some hospitals reported benefits for patients after refining the model, but the process took at least a year.”

Anthem and Humana enter into multimillion agreement with SS&C for API cloud platform: “Anthem, Humana and SS&C Technologies have entered into a joint venture named DomaniRx to develop a claims adjudication and pharmacy benefits manager cloud platform, according to documents filed by SS&C Technologies with the Securities and Exchange Commission.
SS&C Technologies holds an 80.2% interest, and Humana and Anthem each hold a minority interest, according to the agreement filed with the SEC on July 15. 
The parties have committed up to an aggregate of approximately $925 million in the form of cash, property and/or services to support the development project, according to the filing.  
This amount includes $138,300,000 in initial cash contributions, certain assets of the parties, including a nonexclusive license to the claims processing platform known as RxNova, an assignment to a services agreement the company has with Humana, and up to approximately $400 million in cash, other property interests, and/or services.”

Poverty and Access to Internet, by County: This AHRQ interactive page makes the point that internet access should be considered a social determinant of health. See Yesterday’s blog for the case that connectivity should also be a vital sign. Here is an article from today’s JAMA Network that references this AHRQ page: Internet Access as a Social Determinant of Health

About health insurance

The future of accountable care organizations and Medicare’s other payment models: This morning, I listened to an excellent presentation by Harvard Professor Michael Chernew, who is also the chair of MedPAC. I highly recommend it! And in a related article: The Little-Known Agency That’s Trying To Boil The Ocean—A Look At CMMI’s Decade Of Trying To Change Medicare & Medicaid: Former Senate majority leader and cardiac surgeon, Bill Frist, discusses the Center for Medicare and Medicaid Innovation, its initiatives, what works and what does not work.

Millions of Medicare Part D Enrollees Have Had Out-of-Pocket Drug Spending Above the Catastrophic Threshold Over Time: “In 2019, nearly 1.5 million Medicare Part D enrollees had out-of-pocket spending above the catastrophic coverage threshold. Looking over a five-year period (2015-2019), the number of Part D enrollees with out-of-pocket spending above the catastrophic threshold in at least one year increases to 2.7 million, and over a 10-year period (2010-2019), the number of enrollees increases to 3.6 million.” As usual with KFF, the article has helpful graphics.

Florida physician sentenced in $20M healthcare fraud scheme: “Richard Davidson, MD, 42, of Delray Beach, was sentenced about 10 months after entering a guilty plea. He admitted that he and his conspirators established a conglomerate of durable medical equipment companies that they used to submit illegal claims to Medicare. Mr. Davidson said they placed the companies in the names of straw owners, which enabled them to submit high volumes of illegal durable medical equipment claims to Medicare, according to the Justice Department.” Note: As usual, this large fraud was committed against a federal, fee-for-service program.

Centene posts $535M loss in second quarter of 2021: “Centene Corporation posted a $535 million loss in the second quarter of 2021, down from its $1.2 billion haul in the prior-year quarter.
Despite the loss, the company is the black for the first half of the year, according to its earnings report released Tuesday morning, with $164 million in profit through the first two quarters. By comparison, Centene boasted $1.3 billion in profit for the first half of 2020.”

About pharma

FDA generic drug approvals falling, analysis finds: “In the first half of 2021, the FDA gave full approval to 343 generic drugs and gave 72 tentative approvals. In the first half of 2020, it gave full approval to 361 generic drugs and gave 92 tentative approvals. 
The agency has seen a steady decline in new generic drug sumbisisons from drugmakers, Politico reported. In the first half of this year, the FDA received an average of  66 generic drug submissions per month, down from a high of 94 per month in 2017.”

Jury Orders Novartis to Pay $178 Million for Patent Violation: “A jury in the U.S. District Court for the Northern District of California has ordered Novartis to pay $177.8 million to Plexxikon, a subsidiary of Daiichi Sankyo, for infringing on two of the Japanese company’s patents.
Novartis’s Tafinlar (dabrafenib) is a kinase inhibitor indicated for treating patients with unresectable or metastatic melanoma with the BRAF V600E gene mutation. It competes with Zelboraf (vemurafenib), another BRAF inhibitor that was discovered by Plexxikon and licensed to Roche.”

About the public’s health

Many articles in the news the past week about health disparities and racism:
What US News' equity analysis reveals about racial gaps in hospital care: 5 takeaways: For example: “Only 29 percent of hospitals treated a proportion of Black patients comparable to or higher than their community's Black population. This figure sat at 18 percent for Hispanic patients and 5 percent for Asian/Pacific Islander patients.”
Changes in Racial and Ethnic Disparities in Access to Care and Health Among US Adults at Age 65 Years: “In this cross-sectional study that uses a regression discontinuity design, eligibility for Medicare at age 65 years was associated with marked reductions in racial and ethnic disparities in insurance coverage, access to care, and self-reported health.”
From the AMA: Defining racism is key to helping doctors advance health equity: The article, along with a video and reference to an action plan, has a useful glossary of terms.
Racial and Ethnic Disparities in Outpatient Visit Rates Across 29 Specialties: “Racial and ethnic minority groups are markedly underrepresented in the outpatient practices of most medical and surgical specialties. Disparities persisted after accounting for several social determinants of access to care.
Several factors may underlie these findings. Racial/ethnic minority groups are more likely to reside in areas with a shortage of physicians and less likely to receive specialty referrals from primary care physicians. The history of racism in health care may lead non-White patients to distrust the health care system, suppressing utilization. Physicians are less likely to grant appointments for patients with Medicaid or without insurance, who are disproportionately members of racial/ethnic minority groups. A higher burden of end-stage kidney disease and nearly universal Medicare coverage for patients with this disease may explain the high nephrology visit rates for individuals of racial/ethnic minority groups.”
I copy most of the Discussion section since the article is available by subscription-only. If you can get the original, the differences by specialty and race displayed in the chart are interesting.

Fauci Wants to Make Vaccines for the Next Pandemic Before It Hits: “The idea is to make ‘prototype’ vaccines to protect against viruses from about 20 families that might spark a new pandemic. Using research tools that proved successful for Covid-19, researchers would uncover the molecular structure of each virus, learn where antibodies must strike it, and how to prod the body into making exactly those antibodies.”

BioNTech says it will create an mRNA-based vaccine to prevent malaria: The headline is the story.

WHO reports progress in the fight against tobacco epidemic: “More than four times as many people are now covered by at least one WHO-recommended  tobacco control measure as compared with 2007. The six MPOWER measures are monitoring tobacco use and preventive measures; protecting people from tobacco smoke; offering help to quit; warning about the dangers of tobacco; enforcing bans on advertising, promotion and sponsorship; and raising taxes on tobacco.
Some 5.3 billion people are now covered by at least one of these measures - more than four times the 1 billion who were covered in 2007.”

About hospitals and health systems

Best Hospitals by Specialty: The annual US News report. “Of the nearly 5,000 hospitals analyzed and 30,000 physicians surveyed, only 175 hospitals ranked in at least one of the specialties.” Here are the top 10 overall:

• 1. Mayo Clinic, Rochester, Minnesota.

• 2. Cleveland Clinic.

• 3. UCLA Medical Center, Los Angeles.

• 4. Johns Hopkins Hospital, Baltimore.

• 5. Massachusetts General Hospital, Boston.

• 6. Cedars-Sinai Medical Center, Los Angeles.

• 7. New York-Presbyterian Hospital-Columbia and Cornell, New York.

• 8. NYU Langone Hospitals, New York.

• 9. UCSF Medical Center, San Francisco.

• 10. Northwestern Memorial Hospital, Chicago.

Despite raising guidance for 2021, UHS still has concerns about COVID's strain on labor markets: “Universal Health Services has followed in the wake of other outperforming for-profit health systems during the second quarter of 2021, reporting $325 million in profits and a 17.1% year-over-year increase in net revenues as patients returned to its hospitals and behavioral health services.
But while the strong performance allowed UHS to increase its forecast for the remainder of 2021—it now predicts net revenues for the year will fall between $12.12 billion and $12.36 billion—executives warned investors that continued acceleration of recent COVID-19 case trends could take a bite out of its sunny forecast.”

Today's News and Commentary

About Covid-19

‘A tipping point’: Government officials, health groups move to require coronavirus vaccines for workers: “The Department of Veterans Affairs, which runs one of the nation’s largest health systems, announced Monday it would mandate coronavirus vaccines for its front-line workers, becoming the first federal agency to do so and signaling what some experts said could be a national pivot to such requirements.
Faced with the explosive growth of a new virus variant, the state of California and the city of New York rolled out similar mandates. And an array of hospitals from coast to coast, including the prestigious Mayo Clinic, declared they would require staff to get vaccinated, following a joint plea from the nation’s major medical groups.”

Single AstraZeneca Vaccine Dose Highly Effective Against Delta Variant, Study Says: “Canadian researchers found that one dose of the AstraZeneca’s COVID-19 vaccine, Vaxzevria, was highly effective at preventing hospitalization or death caused by the Delta variant.
A single dose was found to be 87 percent effective against the Delta variant, 90 percent effective against the Alpha variant and 82 percent effective against the Gamma/Beta variant, said researchers from the Canadian Immunization Research Network.”

UK Researchers Endorse Eight-Week Separation of Pfizer Vaccine Doses: “Although the authorized dose interval for the vaccine is three weeks, a study commissioned by the UK’s Department of Health and Social Care found that a 10-week interval between doses produced more antibodies and T-cells against infection.
However, given concerns about the rapidly spreading Delta variant, an 8-week window was deemed preferable by the researchers from Oxford and Newcastle universities.”

Families of men in notorious syphilis study speak up for vaccination: “A short-form documentary featuring the descendants of the men involved in the U.S. Public Health Service Syphilis Study at Tuskegee sets the record straight on what happened, what has changed and what current generations can learn from the experience to build confidence in public health within Black communities, especially as it relates to the COVID-19 vaccines.”

About health insurance

Healthcare for older immigrants sees momentum among states: “Illinois is among a handful of Democratic-run states extending health insurance coverage to adult immigrants in the country illegally, including seniors. The state, which became the first to offer a Medicaid-like program for older immigrants last year, used a new budget to expand the program. California followed suit, including coverage for those 50 and over in the latest budget. And Oregon’s governor signed a plan this week offering benefits to low-income immigrants over 19. New York advocates are banking on the momentum to do the same.”

Gig Workers Paying 54% Less For Health Insurance, New Data Shows: “According to new data from Stride, a benefits platform for independent workers, health insurance enrollment increased sixfold in April compared to the same time last year. Year to date, nearly as many people have signed up for health insurance as did during the annual open enrollment period at the end of 2020, the company reported.
Of rideshare and delivery drivers who have signed up for health insurance since March, 60% have enrolled in higher-tier Marketplace plans—Silver, Gold, and Platinum—a 33% jump since before the ARP became law. The higher the metallic tier, the more generous the coverage.
At the same time, the costs for coverage have gone down for these workers. The average premium for rideshare and delivery drivers dropped by more than half, from $171 in March to an average of $80 since then.”

A look at SCAN's new medical group for homeless patients: “SCAN Group, which owns SCAN Health Plan, is launching a new medical group that aims to provide specialized care to patients struggling with homelessness.
The new medical group, Healthcare in Action, will serve SCAN's members and is seeking partnerships with other health plans. The group will provide "street medicine" to seniors, which is one of the fastest-growing homeless populations.”

Medicaid Benefits No Barrier to Green Cards, Agency Chief Says: “The CMS is releasing an informational bulletin to the state Medicaid agencies reaffirming that the receiving benefits under the Medicaid program or the Children’s Health Insurance Program will have no bearing on an applicant’s immigration status…”

AHIP, Other Stakeholders Support Medicare Value-Based Care Bill: “In a joint letter to the four representatives who introduced the bill in the House of Representatives, payer and provider organizations have thrown their support behind the Value in Health Care Act of 2021 which seeks to bolster Medicare value-based care.
Signees included AHIP, Premier, and the National Association of Accountable Care Organizations (ACOs).”

About healthcare IT

Connectivity, digital tools becoming the ‘sixth vital sign’ in health care: A fascinating, but obvious concept. People rely so much on the internet (clinical information, appointment booking, insurance information, etc.) that we should make connectivity a standard question.

About the public’s health

Marlboro Maker CEO Says The Company Plans To Stop Selling Smokes In The U.K.: “Tobacco giant Philip Morris International says it will stop selling cigarettes in the United Kingdom within the next decade — including the company's iconic Marlboro brand.
‘It will disappear,’ the company's CEO Jacek Olczak said in an interview… ‘The first choice for consumers is they should quit smoking. But if they don't, the second best choice is to let them switch to the better alternatives.’”

About diagnostics

PerkinElmer inks massive $5.25B deal for reagent producer BioLegend: “PerkinElmer aims to cement itself as a major provider of reagents and consumables for precision medicine and diagnostic test development through a $5.25 billion deal for BioLegend, a global producer of antibodies and other research tools.
In what will become the company’s largest acquisition ever, PerkinElmer will hand over $2.2 billion in stock to BioLegend shareholders, with the remainder made up of cash-on-hand and newly issued debt, as well as bridge financing from Goldman Sachs. The deal is slated to close before the end of this year.”

Today's News and Commentary

About Covid-19

The Delta Variant Will Drive A Steep Rise In U.S. COVID Deaths, A New Model Shows: “The current COVID-19 surge in the U.S. — fueled by the highly contagious delta variant — will steadily accelerate through the summer and fall, peaking in mid-October, with daily deaths more than triple what they are now.
That's according to new projections released Wednesday from the COVID-19 Scenario Modeling Hub, a consortium of researchers working in consultation with the Centers for Disease Control and Prevention to help the agency track the course of the pandemic.”

Biden administration sends more cash to hard-hit areas as Delta variant surges: “The White House is directing $100 million of additional spending and deploying dozens of federal health workers to shore up vaccine outreach and Covid-19 tracking in rural and heartland states as the Delta variant continues to surge.
The new steps come as new cases and hospitalizations continue to spike while vaccination rates have stalled at 68 percent of adults, with uptake far lower in some parts of the South. The more transmissible Delta variant now accounts for 83 percent of cases nationwide.”

US hospitals in scramble to make room amid rising COVID-19 case count, dwindling bed capacity: The article has snapshots from four states where some facilities are facing capacity strains.

Study Claims J&J Vaccine Much Less Effective Against Delta, Lambda Variants: “Johnson & Johnson’s (J&J) single-dose vaccine is far less effective against the Delta and Lambda strains of the SARS‑CoV‑2 virus than against the original coronavirus, researchers at New York University (NYU) reported.”

3 states responsible for 40% of COVID-19 cases: “Florida, Texas and Missouri accounted for 40 percent of new COVID-19 cases reported nationwide this week, Jeff Zients, the White House's COVID-19 response coordinator, said July 22.
’The data is clear: The case increases are concentrated in communities with low vaccination rates,’ Mr. Zients said during a news briefing, pointing to the three states.”

About the public’s health

Mississippi's attorney general asks Supreme Court to overturn Roe v. Wade: “Mississippi’s attorney general urged the Supreme Court in a Thursday brief to overrule Roe v. Wade next term when the justices review Mississippi’s ban on virtually all abortions after 15 weeks of pregnancy.
Calling the court’s precedent on abortion “egregiously wrong,” Attorney General Lynn Fitch (R) explicitly set the dispute over Mississippi’s restrictive law on a collision course with the landmark 1973 decision in Roe that first articulated the constitutional right to abortion.”

Superbug’ fungus spread in two cities, health officials say: “U.S. health officials said Thursday they now have evidence of an untreatable fungus spreading in two hospitals and a nursing home.
The ‘superbug’ outbreaks were reported in a Washington, D.C, nursing home and at two Dallas-area hospitals, the Centers for Disease Control and Prevention reported. A handful of the patients had invasive fungal infections that were impervious to all three major classes of medications…
The fungus, Candida auris, is a harmful form of yeast that is considered dangerous to hospital and nursing home patients with serious medical problems. It is most deadly when it enters the bloodstream, heart or brain. Outbreaks in health care facilities have been spurred when the fungus spread through patient contact or on contaminated surfaces.”

About pharma

Pfizer Drops Lawsuit Against J&J Over Remicade Biosimilar Coverage: “Pfizer withdrew a 2017 lawsuit against Johnson & Johnson (J&J) that alleged the company used anticompetitive practices to stop insurance companies from covering Pfizer’s biosimilar of rheumatoid arthritis drug, Remicade (infliximab).  
Pfizer alleged that J&J violated antitrust laws by telling insurers it would withhold certain rebates on Remicade unless they limited their coverage of Pfizer’s biosimilar, Inflectra, which allowed J&J to corner the market on the drug.”
I wonder if President Biden’s pro-generic stance and fight against anti-competitive actions contributed to this decision.

About diagnostics

European Commission launches months-long antitrust investigation into Illumina’s $8B bid for Grail: “The European Commission has opted for a deeper probe into the DNA sequencing giant’s $8 billion proposal for the cancer blood test maker Grail, citing concerns that the vertical takeover of its former spinout could harm R&D efforts at competing diagnostic companies.”

About health insurance

Humana, Centene opioid recovery drug suits dismissed: “A district judge dismissed a pair of lawsuits from Humana and Centene against Indivior over alleged attempts to suppress competition of Suboxone, its opioid recovery drug. 
The lawsuits were thrown out because both insurers were considered indirect purchasers of Suboxone, voiding their standing to sue via the Racketeering Influenced and Corrupt Organizations Act, according to the court opinion.”

Out-of-pocket [OOP] costs for preventive care persist almost a decade after the Affordable Care Act: “We found that in addition to premium costs meant to cover preventive care, Americans with employer-sponsored insurance were still charged between $75 million and $219 million in total for services that ought to be free to them ($0.50 to $1.40 per ESI-covered individual and $0.75 to $2.17 per ESI-covered individual using preventive care). However, some enrollees still faced OOP costs for eligible preventive services ranging into the hundreds of dollars. OOP costs are most likely to be incurred for women's services (e.g., contraception) and basic screenings (e.g., diabetes and cholesterol screenings), and by patients in the South or in rural areas.”

UnitedHealthcare awarding $11.4M to social determinants programs in 18 states: ”The insurer first launched its Empowering Health program in 2018 and has since then awarded more than $40 million in grants, establishing partnerships with community organizations across 26 states.
UnitedHealthcare said that these investments have reached more than 6 million people.
The insurer will award $1 million to organizations in four states: Indiana, New York, Nevada and Mississippi. $900,000 will be made awarded to groups operating in Virginia, UnitedHealthcare said.”

As the Pandemic Eases, What Is the State of Health Care Coverage and Affordability in the U.S.?: A really good review of this topic from the Commonwealth Fund. For a quick overview of the results, scroll down and check the chart pack links on the left.