Today's New and Commentary

About Covid-19

Omicron variant identified in U.S.: First case of covid-19 linked to new variant found in California: “The first U.S. case of covid-19 linked to the new omicron variant has been identified in California in a traveler who returned from South Africa on Nov. 22, the Centers for Disease Control and Prevention said Wednesday.
The patient has mild symptoms that are improving and is in self-quarantine.”

Counterfeit Covid Masks Are Still Sold Everywhere, Despite Misleading Claims: “Consumers who try to purchase N95 masks, mainly on Amazon, are often led to vendors selling fake or poorly made KN95s, a Chinese-made mask that is often marketed as an N95 equivalent despite the lack of testing by U.S. regulators to confirm virus-filtering claims.”

Courts block two Biden administration COVID vaccine mandates: “U.S. District Judge Terry Doughty in Monroe, Louisiana, temporarily blocked the Centers for Medicare & Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can resolve legal challenges.
Doughty's ruling applied nationwide, except in 10 states where the CMS was already prevented from enforcing the rule due to a prior order from a federal judge in St. Louis.”

Stricter coronavirus testing being weighed for all travelers to U.S.: “As part of an enhanced winter covid strategy Biden is expected to announce Thursday, U.S. officials would require everyone entering the country to be tested one day before boarding flights, regardless of their vaccination status or country of departure. Administration officials are also considering a requirement that all travelers get retested within three to five days of arrival.”

Early tests show Regeneron drug may be less effective against Omicron: “The findings were the first sign that treatments developed to tackle Covid-19 may have lost effectiveness as the virus evolves. ‘The individual mutations present in the Omicron variant indicate that there may be reduced neutralisation activity of both vaccine-induced and monoclonal antibody conveyed immunity,’ Regeneron said on Tuesday.”

About health insurance

Nevada jury sides with TeamHealth, rules UnitedHealthcare underpaid its providers: “A Nevada jury ruled this week that UnitedHealthcare underpaid physicians at three TeamHealth affiliates in the state, dealing the insurer a blow in its ongoing back-and-forth with the physician staffing company.
The jury awarded TeamHealth $2.65 million in compensatory damages and is weighing how much UnitedHealthcare will owe in punitive damages. The jury reached a decision following two days of deliberation and nearly three weeks of testimony.”

CMMI pulls seriously ill component of Primary Care First after beneficiary uptake concerns: “The Biden administration has pulled the seriously ill population component of the Primary Care First model due to concerns it won't get enough beneficiaries to participate.
The Center for Medicare and Medicaid Innovation (CMMI) announced the withdrawal of the population component on Tuesday. The center had frozen that part of the primary care model in the spring, part of a larger review of all its models.”

Supreme Court weighs whether hospital drug cuts are valid: “The U.S. Supreme Court heard oral arguments Tuesday about whether the federal government had the authority to cut hospitals' payments for outpatient drugs…

  • Hospitals pocket large savings when acquiring certain drugs through a federal program called 340B.

  • Medicare, under the Trump administration, instituted a 28.5% cut to those drug payments starting in 2018. Research indicated some hospitals were profiting excessively from the program.

  • Justices peppered both sides about whether Medicare's rate adjustment abided with the law.
    Zoom in: 
    The crux of the case falls on the so-called Chevron doctrine, which says federal agencies like Medicare have some leeway to interpret ambiguous laws, and courts should defer to them.”

Chicago Woman Sentenced to 56 months for Home Health Care Fraud: “An Illinois woman was sentenced yesterday in the Northern District of Illinois to 56 months in prison and ordered to pay $6.3 million in restitution for her participation in a conspiracy to commit health care and wire fraud.
According to court documents, and the evidence presented at trial, Angelita Newton, 43, of Chicago, worked at Care Specialists, a home health care company owned by Ferdinand Echavia and later his wife, Ma Luisa Echavia. While operating between 2011 and 2017[emphasis added], Care Specialists fraudulently billed Medicare at least $6.3 million. At trial, the government demonstrated that around 90% of the patients were not homebound and did not qualify for the types of care that Care Specialists billed Medicare for. Further, many patients received cash bribes to receive home health “visits,” some of which were performed in the visiting nurse’s car. Newton facilitated the conspiracy by falsifying patient visit records which were used to support claims billed to Medicare and was convicted by a federal jury on Feb. 14, 2020.”

Enrolling Elderly and Disabled Medicaid Beneficiaries in Managed Care Can Achieve Better Outcomes and Save $150 Billion over 10 Years: From United Health Group.

About the public’s health

HIV and Gay and Bisexual Men: Differences in Knowledge of Status, Prevention, Treatment, and Stigma Exist by Race/Ethnicity: An update from the CDC. Here is a summary:
”There are ongoing racial/ethnic differences in knowledge of status and HIV prevention and treatment outcomes among gay and bisexual men.

  • About 20% of Hispanic/Latino, 17% of Black/African American, and 10% of White gay and bisexual men are unaware of their HIV status.

  • Among gay and bisexual men who could benefit from PrEP, only 27% of Black/African American, 31% of Hispanic/Latino, and 42% of White gay and bisexual men reported using PrEP in 2017.

  • Around 38% of Black/African American, 33% of Hispanic/Latino, and 26% of White gay and bisexual men with HIV are not virally suppressed.

  • Black/African American and Hispanic/Latino gay and bisexual men experience higher levels of HIV stigma, with scores more than twice the national goal.”

Nation’s first overdose-prevention centers for street drug users open in New York: “The nation’s first overdose-prevention centers opened in New York City on Tuesday, a major step in the adoption of a harm-reduction approach to the drug epidemic as the number of U.S. overdose deaths continues to soar.
Trained staff at two locations operated by a nonprofit organization in northern Manhattan will monitor drug users as they consume street drugs, prepared to step in if anyone overdoses, according to New York City health officials.
They are equipped with the opioid antidote naloxone and oxygen, the two critical tools in reversing overdoses from narcotics such as fentanyl, by far the most common killer of drug users.”

Today the Supreme Court reconsiders Roe v. Wade: A really good overview of the issues and how the justices may vote.

Higher Coffee Consumption Is Associated With Slower Cognitive Decline and Less Cerebral Aβ-Amyloid Accumulation Over 126 Months: Data From the Australian Imaging, Biomarkers, and Lifestyle Study: “Our results further support the hypothesis that coffee intake may be a protective factor against AD, with increased coffee consumption potentially reducing cognitive decline by slowing cerebral Aβ-amyloid accumulation, and thus attenuating the associated neurotoxicity from Aβ-amyloid-mediated oxidative stress and inflammatory processes. Further investigation is required to evaluate whether coffee intake could be incorporated as a modifiable lifestyle factor aimed at delaying AD onset.”

About pharma

Jury Says BGI Owes Illumina $8M For Infringing DNA Patents: “A California federal jury determined Tuesday that four out of five of Illumina's patents behind its next-generation genome-sequencing technology were valid, finding that Illumina's Chinese rival BGI Genomics and its subsidiaries willfully infringed the patents and must pay Illumina $8 million in damages, according to a person familiar with the case. After about a week of deliberations, the jury determined that BGI — China's largest provider of sequencing services — willfully infringed Illumina's patents, while also determining that Illumina's U. S. Patent 7,541,444 is invalid as obvious, the source said.”

U. of Washington Scientists Invent Wearable Device for Opioid Overdoses: “The wearable injector system measures respiration and apnea associated with an opioid overdose using a pair of on-body sensors and administers naloxone subcutaneously upon detection of a halt in breathing.”

Get ready for M&A: Large biopharma companies will have $1.7T in dealmaking firepower next year, analyst says: “Eighteen large-cap U.S. and European biopharmas will have more than $500 billion in cash on hand by the end of 2022, SVB Leerink analyst Geoffrey Porges and his team wrote in a Wednesday note. The companies could use the money to strike deals, pay down debt or offer returns to shareholders through dividends or share buybacks, the analysts said.
Because the companies can leverage their assets to borrow additional capital, the theoretical firepower of the 18 drugmakers would be enormous at more than $1.7 trillion, the analysts wrote.”

23andMe Earmarks Cash From SPAC Deal for Drug Development: “Sunnyvale, Calif.-based 23andMe went public in June through a merger with VG Acquisition Corp., a special-purpose acquisition company backed by British billionaire Richard Branson. The company, founded in 2006, raised roughly $592 million in gross proceeds through the transaction. It had about $700 million in cash on hand as of Sept. 30.
23andMe plans to deploy the cash from its SPAC deal largely to fund ongoing investments into drug discovery, Chief Financial Officer Steve Schoch said. After years of selling at-home tests, the company created a therapeutics division six years ago, aiming to use its massive database of genetic information to identify new treatments. The database had information from about 11.9 million consumers as of Sept. 30.
By querying its database, 23andMe can find causal links between genetic variations and diseases and use that information to develop new treatments, Mr. Schoch said. Among its findings so far: evidence of genetic variants that bolster the immune system and decrease the risk of cancer….
The company has used its database to identify more than 40 possible drug targets to treat types of diseases.”

About healthcare IT

Planned Parenthood Los Angeles says hack breached 400,000 patients’ information: “A hacker gained access to the personal information of hundreds of thousands of Planned Parenthood patients last month, the reproductive health-care group’s Los Angeles branch said Wednesday.
The breach is limited to the Los Angeles affiliate, and spokesperson John Erickson said there is no indication at this point that the information was ‘used for fraudulent purposes.’”


Today's News and Commentary

About Covid-19

Judge blocks Biden vaccine mandate for healthcare workers in Missouri, 9 other states: “U.S. District Judge Matthew Schelp in the Eastern District of Missouri, who was nominated by then-President Donald Trumpin 2019, wrote in his 32-page ruling that Congress did not grant the Centers for Medicare & Medicaid Services (CMS), a federal agency within the U.S. Department of Health and Human Services, authority to mandate the vaccine.”
And in the past few hours: Judge in Ky. blocks federal contractor vaccine mandate, granting AG Cameron’s request: “‘This is not a case about whether vaccines are effective. They are,’ [Judge]Van Tatenhove wrote. ‘Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can.’ He said that the question before him was a narrow one: whether or not Biden had the authority to impose vaccines on the employees of federal contractors and subcontractors…
The scope of the injunction applies to Kentucky, Ohio and Tennessee, per the order.”

Moderna chief predicts existing vaccines will struggle with Omicron: “Stéphane Bancel foresees ‘material drop’ in current jabs’ effectiveness, sending stocks and oil prices lower.”

Pfizer CEO confident Covid treatment pill will be effective against omicron variant: “‘The good news when it comes to our treatment, it was designed with that in mind, it was designed with the fact that most mutations are coming in the spikes,’ Bourla told CNBC’s ‘Squawk Box.’ ‘So that gives me very high level of confidence that the treatment will not be affected, our oral treatment will not be affected by this virus.’”

Federal agencies won’t seriously discipline vaccine holdouts until next year, White House tells unions: “The American Federation of Government Employees said Monday that administration officials have told the union that agencies for now will continue offering counseling and education to the roughly 3.5 percent of workers who have yet to receive a vaccination or request an exemption.”

FDA advisers narrowly recommend authorization of first antiviral pill to treat covid-19: “The drug, molnupiravir, was developed by Merck and Ridgeback Biotherapeutics as a five-day regimen to be taken at home within five days of the onset of coronavirus symptoms. The FDA is not bound by the 13 to 10 vote but typically follows its external advisers’ recommendations. The drug could have an immediate impact on the pandemic if authorized — just as the ominous new omicron variant has emerged, jolting the world with the prospect of a longer and more complicated pandemic…
When given to people at high risk of developing severe illness, molnupiravir cut the risk of death or hospitalization by 30 percent in patients infected with a range of variants including delta, gamma and mu. Molnupiravir has not yet been tested against the omicron variant, but because it works in a different way than vaccines and monoclonal antibodies that train their firepower on the coronavirus spike protein, it is expected to hold up against a wide range of variants.”

About healthcare IT

Fitch places Athenahealth on rating watch negative amid $17B acquisition: “Fitch Ratings placed Athenahealth on rating watch negative following the Watertown, Mass.-based EHR vendor's recent agreement to be acquired by private equity firms Hellman & Friedman and Bain Capital.
The credit rating agency said it expects a material increase in debt to fund the $17 billion transaction and would look to resolve the rating watch negative after the deal's financing terms close…”

Key use cases for artificial intelligence to reduce the frequency of adverse drug events[ADEs]: a scoping review: “We performed a scoping review, summarised the main insights, and identified several use cases in which AI could contribute to reducing the frequency and consequences of ADEs. Most studies only evaluated technical algorithm performance, and very few studies evaluated the use of AI in clinical settings. Research on predicting allergic reactions was scarce and only a small number of studies incorporated genetic data. Most studies were published in the past 5 years, highlighting an emerging area of study, and we expect many more studies in the next few years. Availability of new types of data and access to unstructured EHR notes might further advance the field.”

Global data and analysis on dealmaking, funding, and exits in private-market AI companies: A comprehensive survey of the topics in the headline. One “overall” statistic: “Global AI funding [reached a] record-high $50B in 2021 YTD, up 55% vs. 2020”

About hospitals and health systems

November 2021 National Hospital Flash Report: From KaufmanHall. “Hospitals and health systems nationwide were hit with another month of margin declines in October as rising labor expenses continue to weigh down overall hospital performance, even as pressures from high levels of high acuity cases showed signs of waning. Actual hospital operating margins held relatively steady for a fourth consecutive month as a result. The median Kaufman Hall Operating Margin Index was 3.2% in October, not including federal CARES Act funding. With the aid, it was 4.1%.”

About health insurance

Justices Skeptical of HHS Changes to Hospitals’ Extra Payments: “A majority of justices on the Supreme Court seemed reluctant Monday to reinstate a 2005 rule that in many cases decreased the amount of additional Medicare payments hospitals get for serving a larger share of poor patients….
At issue are changes the HHS made to how the supplemental payments, known as disproportionate share hospital (DSH) adjustments, are calculated.” Read the article for an explanation of the methodologies that are being challenged.

Temporary Safety-Net Policies and Pandemic-Related Insurance Loss in New York State: Results of this RAND study of NY state can, perhaps, be generalized to other locations:
”Temporary provisions played an outsized role in stabilizing coverage in 2020 and will continue to play a large role in 2021

  • This analysis and emerging evidence from other sources suggest that temporary policies — notably, continuous Medicaid enrollment and furlough coverage — are major contributing factors to the success of the health insurance safety net.

  • The temporary extension and enhancement of APTCs likely contributed to enrollment stability in 2021.

  • Workers' ability to retain job-based coverage after being laid off may have been a substantial factor in holding national insurance rates steady.

  • On their own, the ACA's coverage provisions might not have fully prevented insurance loss during the COVID-19 pandemic.”

About the public’s health

2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association: Read the article for specifics. In general, lots of “common sense” recommendations:
”Evidence-based dietary pattern guidance to promote cardiometabolic health includes the following: (1) adjust energy intake and expenditure to achieve and maintain a healthy body weight; (2) eat plenty and a variety of fruits and vegetables; (3) choose whole grain foods and products; (4) choose healthy sources of protein (mostly plants; regular intake of fish and seafood; low-fat or fat-free dairy products; and if meat or poultry is desired, choose lean cuts and unprocessed forms); (5) use liquid plant oils rather than tropical oils and partially hydrogenated fats; (6) choose minimally processed foods instead of ultra-processed foods; (7) minimize the intake of beverages and foods with added sugars; (8) choose and prepare foods with little or no salt; (9) if you do not drink alcohol, do not start; if you choose to drink alcohol, limit intake; and (10) adhere to this guidance regardless of where food is prepared or consumed.“

About healthcare finance

The top 10 healthcare M&A targets in 2022: A list and companies’ details are provided.

Today's News and Commentary

About Covid-19
What could possibly happen over the Thanksgiving Day holiday? As you have probably read, a new strain, Omicron(B.1.1.529), emerged from South Africa and has already spread worldwide. So far, it has not been identified in the U.S., but that discovery is inevitable. The variant is highly infectious and has 50 new mutations (at least 30 on the spike protein). Below are a few thoughts about “where we are” with respect to Covid-19:
1. The emergence of mutations is inevitable and will continue
2. Mutations are more likely to develop in unvaccinated populations, which is why a global approach to control is needed.
3. The problem with global vaccination is not primarily a cost issue- it is logistics and supplies. For example, as previously reported, a shortage of syringes is a major impediment to adequate vaccination.
4. The key question now is whether current vaccines are effective in preventing infection/severe illness with the omicron strain. The answer is not yet known. Vaccine companies are studying the mutations. If a new or modified vaccine is needed, it could take a few months to produce. That timeframe is very long in a pandemic, but “lightening speed” with respect to historical vaccine development.
5. Likewise, it is not know how well current therapies (like monoclonal antibodies) will work against this variant.
6. Regardless of answers to the above unknowns, masking, vaccination and social distancing are still effective measures, regardless of current and future mutations. Fighting this pandemic is a marathon, not a sprint; a great challenge is avoiding prevention fatigue and letting our guard down.
7. Politics will, unfortunately continue to play an adverse role in control. As today’s Washington Post notes: “Two things are true. Most Republicans are vaccinated against the coronavirus. Also, most of those who aren’t vaccinated against the coronavirus are Republican.”

For a good update, see: What we know about Omicron variant that has sparked global alarm (Financial Times)

Merck says its antiviral pill is less effective than initially reported.: “The pharmaceutical company Merck said on Friday that in a final analysis of a clinical trial, its antiviral pill reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent, down from an earlier estimate of 50 percent.
The lower efficacy is a disappointment for the drug, known as molnupiravir, which health officials around the world are counting on as a critical tool to save lives and reduce the burden on hospitals. It increases the importance of a similar, apparently more effective, offering from Pfizer that is also under review by the Food and Drug Administration.”

Pfizer poised to request authorization for coronavirus booster for 16 and 17 year olds: “Pfizer and its partner BioNTech are expected to ask the Food and Drug Administration in the coming days to authorize its booster shot for that age group, according to two people familiar with the situation. The regulators are expected to sign off quickly, said the individuals, who spoke on the condition of anonymity because they were not authorized to discuss the issue.”

About the public’s health

Warning on tackling HIV as WHO finds rise in resistance to antiretroviral drugs:

  • “A new reported issued by the World Health Organization (WHO) is warning that HIV drug resistance is on the rise, reported The Guardian.

  • Four out of five countries with high rates have seen success in suppressing the virus with antiretroviral treatments, according to the agency's latest HIV drug-resistance report.

  • However, the study found an increase in countries reaching a 10% threshold of resistance to a class of drugs which, underlining the need for a move to an alternative treatment, the WHO said. Resistance exceeding the 10% threshold was reported in 21 of 30 countries surveyed.

  • The report said switching from non-nucleoside reverse transcriptase inhibitors was important for children, with nearly half of infants newly diagnosed carrying drug-resistant HIV, according to surveys in 10 sub-Saharan African countries.”

Diabetes Prevention in a U.S. Healthcare System: A Portrait of Missed Opportunities: “Of the 21,448 patients identified as eligible for prediabetes screening, 13,465 (62.8%) were screened in accordance with the USPSTF recommendations. Of those patients screened, 3,430 met the requirements for a prediabetes diagnosis. Only 185 (5.4%) of patients who screened positive for prediabetes received a formal diagnosis of prediabetes, and no patients who received a diagnosis received appropriate treatment for their prediabetes. Women were more likely than men to be screened (p<0.001), and non-Hispanic Whites were less likely than non-Hispanic Blacks and Hispanics to be formally diagnosed even after screening positive (p<0.001).

CDC warns of rising flu infection rates among young people: “While flu activity is low nationally, the CDC noted that more than 90% of new cases found in the past few weeks have been among children and adults aged 5-24.
Most of the cases are of the H3N2 strain, which was last the dominant strain during the 2017-18 flu season. That season saw 710,000 flu-related hospitalizations and 52,000 flu-related deaths in the United States, the worst since the 2009 H1N1 flu pandemic.
Health experts say the strain is particularly troubling as it has a tendency to mutate more rapidly than other variants.”

About pharma

Trends in Use and Expenditures for Brand-name Statins After Introduction of Generic Statins in the US, 2002-2018: “Using 17 years of the Medical Expenditure Panel Study data, this survey study of generic competition among statins found that the end of market exclusivity was associated with $925.60 of annual savings per individual and $11.9 billion in savings for the US.”

About hospitals and health systems

Association of Rural and Critical Access Hospital Status With Patient Outcomes After Emergency Department Visits Among Medicare Beneficiaries: “In this cohort study of 473 152 matched urban and rural Medicare beneficiaries, risk-adjusted all-cause mortality after rural and urban ED visits was similar, particularly for potentially life-threatening conditions. Critical access hospitals had similar outcomes.
Meaning  These findings underscore the importance of rural and critical access EDs for treatment of life-threatening conditions among Medicare recipients and have important policy implications given the continued increase in rural hospital closures.”

Association of Private Equity Investment in US Nursing Homes With the Quality and Cost of Care for Long-Stay Residents: “In this cohort study with difference-in-differences analysis of 9864 US nursing homes, including 9632 residents in 302 nursing homes acquired by private equity firms and 249 771 residents in 9562 other for-profit nursing homes without private equity ownership, private equity acquisition of nursing homes was associated with higher costs and increases in emergency department visits and hospitalizations for ambulatory sensitive conditions.” [Emphasis added]

Cleveland Clinic posts $422M profit in Q3 as staff expenses rise due to latest surge of COVID-19: “Cleveland Clinic generated $422 million in profits for the third quarter of the year as staffing costs and other expenses increased by nearly 13% compared to the same period in 2020.
The hospital system generated a total of $3 billion in the third quarter of the year compared to $2.7 billion in the third quarter of 2020. This was thanks to $2.7 billion in net patient service revenue and $148 million in operating income.”

About healthcare IT

Zero-Day Attacks: From HHS Office if Information Security, a really good overview with examples and their implications: “Collectively, a zero-day attack is a vulnerability that is exploited by threat actors before a patch is developed and applied.
Because no time exists between when the vulnerability is discovered by developers and when it is exploited by threat actors, these vulnerabilities are called ‘zero-days’”
A couple final notes:
“Mitigating zero-day attacks completely is not possible – by nature, they are novel and unexpected attack vectors

  • Patch early, patch often, patch completely
    o Security resources like HC3 can provide insight

    into active zero-days and available patches

  • Implementing a web-application firewall to review incoming traffic and filter out malicious input can prevent threat actors from reaching security vulnerabilities”

About health insurance

Value-based Care Report: From Humana:
”Of Humana’s individual MA [Medicare Advantage] membership, 67%, or 2.65 million, seek care from primary care physicians in value-based agreements.” Visits to the PCP were higher, and ER and hospitalizations were lower in the MA group- especially compared to Original Medicare. These behaviors resulted in an “estimated medical cost savings of 13.4% compared to Original Medicare. That percentage amounts to a $3.1 billion reduction in medical costs that would have been incurred by value-based members during 2020 had they been enrolled in Original Medicare.”

Today's News and Commentary

About Covid-19

Biden administration asks court to lift stay of vaccine-or-test rule: “The Biden administration is asking a federal court to lift an order halting its vaccine-or-test mandate for private employers, arguing that delaying the standard could have ‘significant’ impacts outside the workplace….
Attorneys for the administration also said that if the court rejects the request to lift the overall stay, it should allow the government to impose a requirement in the broader mandate that unvaccinated workers wear masks and be routinely tested for Covid-19 while the issue makes its way through the courts.”

Covid-19 cases in children are up 32% from two weeks ago, pediatricians' group says: “Covid-19 cases in children are up 32% from two weeks ago, according to new numbers published Monday by the American Academy of Pediatrics.
For the week ending November 18, there were at least 141,905 new cases among children, with children making up a disproportionate share of the cases, representing more than a quarter of all new Covid-19 cases for the past week. Children account for 22% of the US population. When the virus first became a known problem in the US in early 2020, kids accounted for fewer than 3% of confirmed cases. Since the start of the pandemic, more than 6.8 million children have tested positive for Covid-19.”

Covid vaccine that creates T-cells ‘gives better immune response than current jabs’: “Study findings suggest an experimental vaccine, dubbed CoVac-1, that is designed to specifically create T-cells against COVID-19 produces a better immune response than the alternatives already in use, reported The Telegraph.
‘The induction of SARS-CoV-2 T-cell immunity is a central goal for vaccine development and of particular importance for patients with congenital or acquired B-cell deficiencies,’ researchers wrote in a paper published in Nature.
The Phase I trial involving 36 people who received CoVac-1 early this year showed the vaccine to be safe and capable of producing a robust immune response.
The scientists said the vaccine's T-cell response ‘surpassed those detected after SARS-CoV-2 infection as well as after vaccination with approved vaccines.’
Data suggest that CoVac-1, a single shot in the stomach, produces 3.5 times as many T-cells as the Pfizer/BioNTech vaccine and 20 times as many as the AstraZeneca vaccine.”

About health insurance

Companies are telling unvaccinated workers to pay more for health insurance: “In a September survey, the Society for Human Resource Management found less than 1% of organizations had raised health insurance premiums for unvaccinated workers and 13% have considered doing so. 
It was higher among large companies, where nearly 20% were considering the move.”
The higher fees resulted in higher vaccination rates.

Uninsured? You may be among the 10 million who could get help paying for private coverage through the public health marketplace: “In addition to the 10 million who could be eligible financial help with coverage through the public health exchange, 7 million more may qualify for Medicaid or the Children’s Health Insurance Program.
Subsidies for marketplace plans are expanded for 2021 and 2022, due to legislation enacted earlier this year.”
In a related article: Obamacare Open Enrollment Is Here; 1.6 Million Have Already Signed Up: “Open enrollment began on November 1, 2021. Already, more than 1.6 million people in 33 states have newly enrolled or renewed their coverage on the marketplace, according to the Centers for Medicare and Medicaid Services (CMS). Of these, approximately 287,000 were new enrollees, while the majority (more than 1.3 million) renewed their coverage from last year.”

Evidence on Surprise Billing: Protecting Consumers with the No Surprises Act: “Research over the past decade shows that surprise billing is relatively common among privately- insured patients. Studies show that, on average, 18 percent of emergency room visits by people withlargeemployercoverageresultinoneormoreout-of-networkbillsandnearly20percentof patients undergoing in-network elective surgeries or giving birth in a hospital received surprise bills. Surprisebillsinthesestudiesaveragedmorethan$1,200foranesthesia,$2,600forsurgical assistants, and $750 for childbirth. All told, more than half of U.S. consumers report having received an unexpectedly large bill.”

Results from the Institute for Medicaid Innovation’s 2021 Annual Medicaid Health Plan Survey: This monograph is a great overview of Medicaid Health Plans. Among the findings:

“In 2020, 100 percent of health plan respondents provided high-risk care coordination for members, and 95 percent tracked the effectiveness of their efforts by monitoring metrics such as emergency department utilization (HEDIS measure; 95%), inpatient utilization (HEDIS measure; 95%), and patient experience survey results (79%)…
Almost all Medicaid health plan respondents (90%) utilized an alternative payment model (APM) or value-based purchasing (VBP) arrangement in 2020, with 100 percent of medium (i.e., 250,001 to 1 million covered lives) and large (over 1 million covered lives) health plans reporting having an arrangement in place. Other key findings from 2020 included:

  • Most respondents (73%) implemented VBP arrangements with a majority of primary care providers.

  • The majority of respondents did not implement VBP arrangements with dentists (89%), nurse-midwives (84%), or orthopedists (84%).

  • Three-quarters (75%) of respondents were required by the state in which their plan operated to implement a VBP or APM contract with providers.

  • Eighty-four percent (84%) of respondents used or considered Healthcare

    Effectiveness Data and Information Set (HEDIS) measures as part of their

    VBP models.

  • The most frequently used payment strategies were payment incentives

    based on performance measures related to access to care (78%), payment incentives for the availability of same-day or after-hours appointments (56%), and enhanced payment rates for hard-to-recruit provider types (56%).

  • From 2017 to 2020, all external factors impacting the adoption of and innovation in VBP/APMs decreased between 16 (provider readiness and willingness) and 83 (impact of 42 CFR Part 2 on limiting access to behavioral health data) percentage points.”

About hospitals and health systems

Higher penalties for undisclosed prices won't sway all hospitals to comply, consultant says: “While CMS' move to increase the penalty for hospitals that don't publish their prices will make some facilities more likely to comply with that requirement, it may not sway the country's largest health systems, Caroline Znaniec, a managing director at advisory firm CohnReznick…
According to Ms. Znaniec, the new noncompliance fee of up to $2 million per year will likely persuade  mid-sized hospitals and health systems to comply with the regulation, but not the larger facilities and health systems. 
’For the extremely large health systems, that amount is not really that large of a fine," Ms. Znaniec said. "I'm hearing from some systems that $2 million is nothing to them. They may be weighing the risks.’”

About the public’s health

Trends in Obesity Prevalence Among Adults Aged 18 Through 25 Years, 1976-2018: “This analysis found that from 1976 to 2018, the prevalence of obesity among emerging adults in the US increased significantly. Limitations of this study include the population being limited to non-Hispanic Black and non-Hispanic White individuals, patterns among whom may not be generalizable to other races or ethnicities, as well as a decline in the NHANES response rate over time.”

Don’t Screen for COPD in Asymptomatic Adults, Says USPSTF: “Based on the available evidence, the task force recommends against screening for COPD in asymptomatic adults. This is a “D” recommendation and pertains only to adults who do not recognize or report respiratory symptoms. It does not apply to individuals who present with symptoms such as chronic cough, sputum production, wheezing or difficulty breathing.
The task force also noted that its evidence review did not include people with alpha-1 antitrypsin deficiency, a hereditary genetic disorder that may cause lung damage and thereby increase the risk for COPD.”

Antibiotic accountability: how countries and companies perform: An excellent global review of antibiotic resistance. Who is over-prescribing, who has the most drug-resistant organisms, and who is doing the most research to combat the problem (by country and company).

About pharma

Two very interesting emerging technologies that could lead to the development of successful oncology drugs:
New insights into how cancer cripples immune cells could fuel fresh I-O approaches and
By putting cancer cells to sleep, new drug could prevent tumor metastasis

About healthcare professionals

Medscape Malpractice Report 2021: Among the highlights:
—51% of physicians have been sued at least once.
—Fewer lawsuits took place during the Covid-19 pandemic
—Failure to diagnose and treatment complications were the leading reasons for suits (unchanged from past reports
—Surgeons of any specialty are most likely to be sued
—Premium rates are rising but many physicians do not know what they are because of their employed status
—80-85% of verdicts are in favor of the of the physician, but rates vary nationally
—52% of respondents to the survey were over age 60.

Today's News and Commentary

About pharma

GAO Shines Spotlight on Dearth of Antibacterial and Antifungal Treatments: “There aren't enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such candidates, the Government Accountability Office (GAO) reported.
Thus far, economics have been an issue. Since the population who needs these drugs is very limited, drug companies can’t recoup their high drug development costs through sales, which has resulted in few drugmakers willing to fund development of such candidates, GAO found.”

Jury holds pharmacies responsible for role in opioid crisis: “Three retail pharmacy chains recklessly distributed massive amounts of pain pills in two Ohio counties, a federal jury said Tuesday in a verdict that could set the tone for U.S. city and county governments that want to hold pharmacies accountable for their roles in the opioid crisis.
The counties blamed pharmacies operated by CVS, Walgreens and Walmart for not stopping the flood of pills that caused hundreds of overdose deaths and cost each of the two counties about $1 billion, their attorney said.”

Prevalence of Medications That May Raise Blood Pressure Among Adults With Hypertension in the United States: “In total, 14.9% (95% CI, 14.1%-15.6%) of US adults reported using medications that may cause elevated BP, including 18.5% (95% CI, 17.5%-19.5%) of adults with hypertension. The most commonly reported classes were antidepressants (8.7%; 95% CI, 8.0%-9.5%), prescription nonsteroidal anti-inflammatory drugs (NSAIDs) (6.5%; 95% CI, 5.8%-7.2%), steroids (1.9%; 95% CI, 1.6%-2.1%), and estrogens (1.7%; 95% CI, 1.4%-2.0%).”

STATEMENT ON UCB RESTRICTING 340B DISCOUNTS THROUGH COMMUNITY-BASED PHARMACIES: “The global drug company UCB has announced that it will stop providing 340B discounts to hospitals on drugs dispensed at community-based pharmacies starting Dec. 13. This development makes UCB the ninth drug company to impose restrictions on 340B pricing through community pharmacies.”

Novartis may have a buyer for $21B generics unit Sandoz: report: “Swedish-based investment group EQT and the Struengmann family of Germany are considering a joint move to purchase the generics outfit for $21.6 billion, according to German newspaper Handelsblatt.
The price would make it the largest pharma deal of the year. EQT and the Struengmanns, who provided the investment power behind BioNTech, have attracted interest from other private equity investors to join the group, the outlet reported.”

EMA listing shows Biogen previously pulled Aduhelm from PRIME scheme: “According to a listing on the European Medicines Agency's (EMA) website, the PRIME designation for Biogen's Alzheimer's disease drug Aduhelm (aducanumab) was withdrawn at the company's request. The treatment, which is currently under review in the EU, was initially accepted for the PRIME programme in 2016…
Last week, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a "negative trend vote" on the Aduhelm filing, suggesting the drug is unlikely to secure European approval…”
In a related article: Amyloid-Related Imaging Abnormalities [ARIA] in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease: “In an integrated safety data set of 2 phase 3 clinical trials (EMERGE and ENGAGE) including 3285 participants, 425 patients (41.3%) in the combined 10 mg/kg aducanumab group (n = 1029) experienced ARIA; ARIA-edema occurred in 362 patients (35.2%), and 94 of these patients (26.0%) experienced associated symptoms (eg, headache, confusion, dizziness, and nausea). ARIA-microhemorrhage and ARIA–superficial siderosis occurred in 197 patients (19.1%) and 151 patients (14.7%), respectively.
Meaning  Amyloid-related imaging abnormalities occurred in approximately 40% of participants in the phase 3 studies of aducanumab, and approximately one-quarter of these patients experienced symptoms.”

About the public’s health

Smoking Cessation in Stroke Survivors in the United States: A Nationwide Analysis: “Among 4 434 604 Americans with a history of stroke and smoking, the median age was 68 years (interquartile range, 59–76), and 45.4% were women. The overall quit ratio was 60.8% (95% CI, 60.1%–61.6%). Quit ratios varied by age group, sex, race and ethnicity, and several geographic factors. There was marked geographic variation in quit ratios, ranging from 48.3% in Kentucky to 71.5% in California. Furthermore, compared with cancer survivors, stroke survivors were less likely to have quit smoking (odds ratio, 0.72 [95% CI, 0.67–0.79]) after accounting for differences in demographics and smoking-related comorbidities.”

About health insurance

BMA: Plans offering extra Medicare Advantage supplemental benefits grow by 43%: “The number of Medicare Advantage plans offering at least one of five recently expanded supplemental benefits increased by 43% from 2021 to the 2022 coverage year, a new analysis finds.
The findings, released Thursday by the Better Medicare Alliance (BMA), come as supplemental benefits not offered by traditional Medicare have become a popular tool by insurers to market MA plans, an increasingly lucrative space for the industry.
Overall, MA plans that offered at least one of the five expanded benefits increased from 575 in 2021 to 824 for 2022, according to the analysis conducted by consulting firm Milliman.”

CVS Health to Invest $7.7 Million in Affordable Housing in Tampa: “CVS Health announced it will invest $7.7 million with Raymond James Tax Credits Funds to build a 61-unit multifamily apartment home development called Uptown Sky for families in Tampa. This investment is part of the company's commitment to address racial inequity and social determinants of health in underserved communities.”

About Covid-19

Judge declines Florida request to block federal mandate for healthcare workers: “A federal judge has denied Florida's request to block a CMS rule requiring vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs, according to court documents.
In an 11-page order issued Nov. 20, U.S. District Judge M. Casey Rodgers wrote that the court found ‘no showing of irreparable injury’ to support a preliminary injunction or temporary restraining order against the federal rule.”

Biden administration lays out some agency vaccination rates: “More than 90 percent of 3.5 million federal employees covered by the Biden administration’s vaccine mandate have received at least one dose, and a ‘vast majority’ of those have been fully vaccinated, White House coronavirus response coordinator Jeff Zients said at a news conference Monday.
The figure is high compared with the approximately 59 percent of the general population that is fully vaccinated…”

About hospitals and health systems

Ascension's net income dips by more than $1B in Q1: “St. Louis-based Ascension posted net income of $80.4 million in the three months ended Sept. 30, a more than $1 billion decrease from the same period last year, according to its quarterly financial report. The large decrease was largely driven by a drop in nonoperating gains, which totaled $79.7 million in the first quarter of fiscal year 2022 and $1.2 billion in the same quarter one year prior…
Ascension's operating expenses rose to $6.9 billion in the first quarter of fiscal 2022, a 6.4 percent increase from the same period in fiscal 2021. Expenses rose in all categories except interest.”

About healthcare personnel

Harris announces $1.5B investment in health care workforce: “Vice President Kamala Harris announced Monday that the Biden administration is investing $1.5 billion from the coronavirus aid package to address the health care worker shortage in underserved communities.
The funding will go to the National Health Service Corps, Nurse Corps and Substance Use Disorder Treatment and Recovery programs, all federal programs that offer scholarship and loan repayments for health care students and workers if they pledge to work in underserved and high-risk communities.”

Today's News and Commentary

About healthcare IT

Athenahealth to be acquired for $17B: 6 details : “Athenahealth has entered an agreement to be jointly acquired by private equity firms Hellman & Friedman and Bain Capital for $17 billion, the Watertown, Mass.-based EHR company said Nov. 22…
The joint investment includes Hellman & Friedman, Bain Capital Private Equity and Bain Capital Tech Opportunities; Veritas Capital and Evergreen Coast Capital, an Elliott Investment Management affiliate, will each keep a minority investment in Athenahealth. 
Veritas and Elliott acquired Athenahealth in February 2019 for $5.7 billion. Under the purchase, the company went private and removed its common stock from Nasdaq.”

Shorter Hospital Stays Associated with Patient Portal Use: “Patients who were hospitalized for either COVID-19 or heart failure were more likely to have shorter hospital stays if they had an active patient portal account.” The authors use this measure as a proxy for patient engagement. The differences between lengths of stay for use and non-use of the portal were minimal only for those over age 85.

About Covid-19

US COVID-19 deaths in 2021 surpass last year's toll: “385,348 COVID-19 deaths — 15 more than the 2020 total —have so far been recorded in 2021, and that number will only rise in the days and weeks to come.”

Pfizer’s coronavirus vaccine trial data confirms high efficacy, long-term protection in adolescents: “Pfizer and BioNTech announced Monday morning that their vaccine provides long-term protection against the coronavirus in youth ages 12 to 15, according to data from their late-stage vaccine trial.
A two-dose series of the vaccine proved to be 100 percent effective against the coronavirus, measured seven days to over four months after the second dose, the company said in a news release.”

The influence of gender and ethnicity on facemasks and respiratory protective equipment fit: a systematic review and meta-analysis: “The literature reports on largely Caucasian or single ethnic populations, and BAME [Black, Asian and minority ethnic] people remain under-represented, limiting comparisons between ethnic groups. Facial anthropometrics vary between gender and likely between ethnicity, which may contribute to lower PR [Pass Rates] among females and ethnic minorities, particularly Asians. There is a need for studies including a broader spectrum of ethnicities and for consideration of female and BAME users during RPE [Respiratory Protective Equipment] development.”

Plant-derived antiviral drug is effective in blocking highly infectious SARS-CoV-2 Delta variant, say scientists: “In a new study published in Virulencea group of scientists, led by Professor Kin-Chow Chang from the School of Veterinary Medicine and Science at the University [of Nottingham], found that the Delta variant, compared with other recent variants, showed the highest ability to multiply in cells, and was most able to directly spread to neighbouring cells. In co-infections with two different SARS-CoV-2 variants, the Delta variant also boosted the multiplication of its co-infected partners.
The study also showed that a novel natural antiviral drug called thapsigargin (TG), recently discovered by the same group of scientists to block other viruses, including the original SARS-CoV-2, was just as effective at treating all of the newer SARS-CoV-2 variants, including the Delta variant.”

About the public’s health

The cost of gun violence in the US, by the numbers: “Every year, gun violence kills nearly 40,000 people in the U.S. and costs the nation $280 billion, including medical, criminal justice and quality-of-life expenses.”

About health insurance

Providers face 40% hit to Part B reimbursements under Dem drug price reforms: “Providers could face a 40% cut on average to their Medicare Part B drug reimbursements under legislation that gives Medicare the power to negotiate a small amount of drug prices in Parts B and D, a new analysis finds.
The analysis, released Thursday by consulting firm Avalere, examines the effect of a drug pricing negotiation framework that was included in a roughly $2 trillion package that passed the House on Friday.”

About pharma

BioNTech's skin cancer therapy wins FDA's fast track designation: “The U.S. Food and Drug Administration (FDA) granted the fast track status to the BNT111 infusion, which is designed to instruct the body to produce four proteins that are characteristic of melanoma cells and trigger an immune response against those cancer cells in the body.” It is based on mRNA technology.

About hospitals and health systems

AdventHealth's net income slides in Q3: “AdventHealth, a 46-hospital system based in Altamonte Springs, Fla., recorded higher revenue in the third quarter of 2021, but ended the period with lower operating income, according to recently released financial documents…
The boost largely was driven by an increase in net patient service revenue….
The decrease in operating income was attributed to an increase in expenses, which grew from nearly $3 billion in the third quarter of 2020 to $3.5 billion in the third quarter of 2021.
AdventHealth said expenses increased because contract labor costs are still at elevated levels, supply costs are up and it saw higher-acuity patients.”

Advocate Aurora's operating income narrows in Q3: “Despite posting higher revenue in the third quarter of 2021, Advocate Aurora Health saw its operating income shrink when compared to the same quarter last year, according to recently released financial documents.
The health system, which has dual headquarters in Milwaukee and Downers Grove, Ill., recorded revenue of $3.6 billion in the third quarter of 2021. In the same period last year, Advocate Aurora had revenue of $3.5 billion. 
Advocate Aurora Health, which has 24 acute care hospitals, also saw its expenses rise in the quarter ended Sept. 30 to $3.4 billion, up 6.3 percent compared to the same quarter last year.”

Tower Health to temporarily close urgent care centers on Sundays: “West Reading, Pa.-based Tower Health will temporarily close its urgent care centers on Sundays starting Nov. 28 because of staffing shortages…”

Today's News and Commentary

House passes $1.7 trillion spending package: 6 healthcare takeaways: A good summary of the healthcare provisions, including “a provision to allow Medicare parts B and D to negotiate prices directly with manufacturers on certain drugs…”

About Covid-19

CDC advisers back coronavirus boosters for all adults, urge them for people 50 or older: “Advisers to the Centers for Disease Control and Prevention endorsed a coronavirus booster-shot-for-all policy Friday, voting 10-to-1 to allow all adults to get an extra shot of the Pfizer-BioNTech or Moderna vaccines. In a separate vote, they recommended the shots for all people 50 or over.”

Dozens of health groups urge businesses to voluntarily adopt Biden’s vaccine rule: “The American Medical Association and more than 60 other health care associations on Thursday called on employers to voluntarily implement President Biden’s contested vaccine-or-testing mandate, saying businesses had no time to waste ahead of the busy holiday season.”

Lower SARS-CoV-2 viral shedding following COVID-19 vaccination among healthcare workers in Los Angeles, California: “Among 880 healthcare workers with a positive SARS-CoV-2 test, 264 (30.0%) infections were identified following receipt of at least one vaccine dose. Median SARS-CoV-2 cycle threshold values were highest among individuals receiving two vaccine doses, corresponding to lower viral shedding. Vaccination might lead to lower transmissibility of SARS-CoV-2.”

Effectiveness of public health measures in reducing the incidence of covid-19, SARS-CoV-2 transmission, and covid-19 mortality: systematic review and meta-analysis: “Eight of 35 studies were included in the meta-analysis, which indicated a reduction in incidence of covid-19 associated with handwashing (relative risk 0.47, 95% confidence interval 0.19 to 1.12, I2=12%), mask wearing (0.47, 0.29 to 0.75, I2=84%), and physical distancing (0.75, 0.59 to 0.95, I2=87%). Owing to heterogeneity of the studies, meta-analysis was not possible for the outcomes of quarantine and isolation, universal lockdowns, and closures of borders, schools, and workplaces.”

Impact of Hospital Strain on Excess Deaths During the COVID-19 Pandemic — United States, July 2020–July 2021: “The conditions of hospital strain during July 2020–July 2021, which included the presence of SARS-CoV-2 B.1.617.2 (Delta) variant, predicted that intensive care unit bed use at 75% capacity is associated with an estimated additional 12,000 excess deaths 2 weeks later. As hospitals exceed 100% ICU bed capacity, 80,000 excess deaths would be expected 2 weeks later.”

UK study suggests Delta subvariant less likely to cause symptoms: “According to a coronavirus prevalence survey, a subvariant of Delta that is growing in the UK is less likely to lead to symptomatic COVID-19 infection, adding that overall cases had dropped from a peak in October, as reported by Fidelity.
The Imperial College London REACT-1 study found that the subvariant, known as AY.4.2, had grown to be nearly 12% of samples sequenced, but only a third had ‘classic’ COVID-19 symptoms, compared with nearly a half of those with the dominant Delta lineage AY.4.
The survey found that two-thirds of individuals with AY.4.2 had "any" symptom, compared with more than three-quarters with AY.4.”

Texas court says hospital can’t be forced to offer ivermectin to covid patient on ventilator: “A Texas appeals court ruled Thursday that a hospital can’t be forced to treat a covid-19 patient in its care with ivermectin, a drug normally used to eliminate parasitic worms, after the patient’s wife sued the hospital to demand the treatment.”

About pharma

Characteristics of Cost-effectiveness Studies for Oncology Drugs Approved in the United States From 2015-2020: “In this cross-sectional study of 116 drug approvals and 228 cost-effectiveness studies and 254 analyses, a drug was 40 times more likely to be deemed cost-effective when the study was funded by pharmaceutical companies compared with no funding.”

J&J previews $60B-a-year future with plans to go after viruses that have long evaded vaccine makers: “Johnson & Johnson has a lofty goal to become a $60 billion-a-year drugmaker by 2025. To reach that goal, the healthcare giant is going to take a crack at a couple of viruses [RSV and HIV] that have long eluded vaccine makers.”
In a related article: Johnson & Johnson expects 14 new blockbusters by the middle of the decade, execs say: “To get there, the company will rely on a combination of established medicines, investigational drugs, and new, innovative therapeutics such as CAR-T meds and gene therapies, Taubert [Jennifer Taubert, executive vice president, worldwide chairman of pharmaceuticals] said. The company has 14 novel medicines on the way, all of which have more than $1 billion in sales potential. Even sweeter, five of those products have the potential to reap $5 billion or more, Taubert said. 
As for its established brands, J&J expects eight products to deliver double-digit revenue growth through 2025. Fourteen established J&J meds are expected to reel in more than $1 billion each by the middle of the decade, Taubert added.”

About 77% of clinical research execs expect to run decentralized trials in next 12 months: survey: “It appears the virtual or decentralized clinical trial landscape is here to stay as the growth of theses studies could outpace new traditional site-based studies in the coming year, according to Science 37.
That's based on a survey of 127 senior clinical research executives conducted during September and October. About 77% of respondents said they plan to run a hybrid trial in the next 12 months compared to 59% for the previous year. That's slightly higher than the 7 in 10 who said they plan to run traditional, site-based studies in the next 12 months.”

CBO: Democrats' package saves about $160B on drug prices: “Provisions to lower prescription drug prices in President Biden's Build Back Better package would save the government about $160 billion over a decade, according to a Congressional Budget Office (CBO) estimate released Thursday.
That includes about $80 billion in savings from allowing Medicare to negotiate lower drug prices in limited instances, and another roughly $80 billion in limiting drug price increases to the rate of inflation…
The CBO estimated that the measure would result in one fewer drug coming to market in the next decade, followed by four in the following decade and five in the decade after that. That's out of about 1,300 drugs expected to be approved in those 30 years.”

First Interchangeable Biosimilar Launched In US: “Viatris and Biocon have introduced their interchangeable Semglee insulin glargine biosimilar in the US, along with an unbranded interchangeable version, marking the first ever launch of an interchangeable biosimilar. The non-interchangeable version is expected to be phased out rapidly.”

Federal Judge Approves $345 Million EpiPen Settlement by Pfizer: “A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions.”

Insurers Balk at Paying for Biogen’s $56,000-a-Year Alzheimer’s Treatment: “None of the 25 large insurers that responded to a Bloomberg News survey judged the $56,000-a-year drug “medically necessary,” a term used to describe treatments that are needed for specific ailments and meet medical standards. Most have deemed Aduhelm experimental, while some say they’re still evaluating it.”

The Most and Least Expensive Cities for Prescription Medications: “Key takeaways:

  • Large coastal cities top the list for the most expensive cities for prescription medications, with New York and Los Angeles ranking in the top two. However, Little Rock, Arkansas, and Milwaukee, cities toward the middle of the country, stray from this pattern and join the top-five list at positions three and four, respectively. 

  • Denver remains the cheapest city for prescription drugs by far, with cash prices more than 38% below the national average.

  • The cost of living and big-box store discounts account for much of the price variation but don’t tell the whole story.”

Pressure grows for funding to tackle ‘silent pandemic’ of antimicrobial resistance: “To remain effective for as long as possible, antibiotics should be tightly targeted: made affordable for all patients who need them, but with their administration otherwise tightly limited to avoid the excessive and improper use that can drive resistance. That requires ‘delinking’ the reward paid to drug developers from the revenues derived directly from their sales, which has encouraged excessive prescriptions. Instead, attention is turning towards a model akin to insurance, with companies paid lump sums or ‘premiums’ to compensate them for developing and stockpiling drugs in the hope they will be available but rarely used.”

About hospitals and health systems

Mayo Clinic operating income more than doubles: “Rochester, Minn.-based Mayo Clinic's revenue totaled $11.71 billion in the first three quarters of this year, up from $9.98 billion in the same period a year earlier. Net medical service revenue was up nearly 19 percent year over year…
The health system's operating expenses climbed 11.2 percent year over year to $10.7 billion in the first three quarters of 2021. Mayo Clinic saw expenses increase across several categories, including supplies and salaries and benefits.”

About the public’s health

CMS says evidence is sufficient to expand Medicare coverage for low-dose CT lung cancer screening: “Under the proposal, Medicare beneficiaries between the ages of 50 to 77 would be eligible, a drop from the previous starting age at 55. CMS also plans to reduce the threshold from 30 pack-years down to 20—meaning 20 cigarettes smoked per day for the past two decades. The new coverage guidelines align with recently updated recommendations from the U.S. Preventive Services Task force, released in March.”

Achieving Racial and Ethnic Equity in U.S. Health Care, A Scorecard of State Performance : A monograph from The Commonwealth Fund: “In this report, we evaluate health equity across race and ethnicity, both within and between states, to illuminate how state health systems perform for Black, white, Latinx/Hispanic, AIAN, and Asian American, Native Hawaiian, and Pacific Islander (AANHPI) populations. Our hope is that policymakers and health system leaders will use this tool to investigate the impact of past policies on health across racial and ethnic groups, and that they will begin to take steps to ensure an equitable, antiracist health care system for the future.”

Single-dose HPV vaccine highly effective, researchers say: “‘The single-dose vaccine was highly effective at 18 months for HPV vaccination,’ said Ruanne Barnabas, principal investigator of the trial and a professor of global health at the University of Washington School of Medicine. ‘The single-dose efficacy was the same as multiple doses.’”

About health insurance

Final 2022 Medicare Physician Payment and Quality Reporting Changes: From the MGMA.
Highlights:
Key 2022 Medicare physician fee schedule (PFS) policies
The 2022 Medicare PFS conversion factor is 33.5893. The Anesthesia conversion factor is 20.9343. The payment penalty phase of the Appropriate Use Criteria (AUC) program is delayed at least one year. Physician assistants can directly bill and reassign payment for their services under Medicare.
CMS is providing an on-ramp for new split (or shared) E/M policies.

Key 2022 MIPS and APMs policies
The performance threshold to avoid a negative adjustment under MIPS is 75 points, and the exceptional performance threshold increased to 89 points. Under statute, the final year of the exceptional performance adjustment under MIPS is the 2022 performance year / 2024 payment year.
PY 2023 will be the first year for eligible clinicians to voluntarily report under an MVP. CMS finalized seven proposed MVPs beginning in the 2023 performance year.
CMS extended the period during which multispecialty groups can report under an MVP without forming a subgroup. Current policy will require multispecialty groups to form subgroups for voluntary MVP reporting beginning in the 2026 performance year.
Reporting via the CMS Web Interface has been extended as a quality reporting option through the 2024 performance year for Medicare Shared Savings Program participants.”

About medical devices

FDA clears Medtronic’s PillCam system for remote endoscopy procedures: “PillCam SB3 is delivered straight to a patient and, via a telehealth appointment, a provider guides the patient through the remote procedure. Over the course of the eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images securely to the cloud where they can be assessed by a GI physician to make a diagnosis. The patient returns the data recorder and sensor belt to Medtronic once the procedure is complete.
The SB3 @Home platform previously held temporary FDA approval during the National Public Health Emergency, while Medtronic’s PillCam capsule endoscopy has been in use for more than 20 years. PillCam SB is now in its third generation and only holds clearance for remote use in the U.S. and not in other geographies.”

Today's News and Commentary

About health insurance

Prescription Drug and Health Care Spending Interim Final Rule with Request for Comments: “On November 17, 2021, the Department of Health and Human Services (HHS), together with the Department of Labor (DOL) and the Department of the Treasury (collectively, the Departments), as well as the Office of Personnel Management (OPM), released an interim final rule with request for comments (IFC), entitled ‘Prescription Drug and Health Care Spending’…
This IFC requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including:

  • General information regarding the plan or coverage;

  • Enrollment and premium information, including average monthly premiums paid by employees versus employers;

  • Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers;

  • The 50 most frequently dispensed brand prescription drugs;

  • The 50 costliest prescription drugs by total annual spending;

  • The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year;

  • Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and

  • The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs.”

URAC unveils new health plan accreditation programs: “URAC, a leading national health care accreditor, announced… that it has launched its new and improved health plan accreditation suite to serve health plans of all sizes. The new programs give health plans a choice for their accreditation.” This site provides an example of criteria.

Biden’s HHS Delays Drug Rule Allowing Multiple Price Points: “The Department of Health and Human Services delayed by six months provisions of a Medicaid drug contract rule that lets manufacturers offer states different prices for the same products.
Drug companies currently offer the same low price to all state Medicaid plans, which is commonly referred to as a drug’s ‘best price.’ The Trump-era rule could allow companies to offer different discounts to different states without forcing drugmakers to lower the price for everyone. However, lawyers said it would have been an administrative nightmare to enforce because the policy wasn’t clear.”

Medicare AEP[Annual Enrollment Period] :Half-Time Report: Although enrollment is continuing, the document is worth a quick read. Among the findings: “While $0 premium plans account for approximately 59% of all Medicare Advantage plans available for 2022, they account for 88% of all Medicare Advantage plans selected at eHealth during the first half of the current Annual Enrollment Period.”

Medicare funding cuts could limit Texans' physician options by two-thirds: “Should the proposed cut go through, the Texas Medical Association said it expects two-thirds of the state's physicians would be forced to stop accepting Medicare patients.
The move also would make 59 percent of physicians consider opting out of Medicare entirely, 42 percent stop treating current Medicare patients and 43 percent consider retirement.”

 About the public’s health

Majority of Physicians Worry Signs of Addiction Were Missed During Pandemic, Finds New Quest Diagnostics Health Trends® Report: “First-of-its-kind study reveals nearly three in four physicians believe telehealth visits limit the ability to determine if patients are at risk for or are already misusing prescription drugs
Four in five physicians say a lack of drug testing during the pandemic put more people at risk for undetected drug misuse or use disorders
76% expect deaths from drug overdose will continue to rise even as the pandemic subsides”

State of Lung Cancer 2021 Report: “While the disease remains the leading cause of cancer deaths among both women and men, over the past five years, the survival rate has increased by 14.5% nationally to 23.7% yet remains significantly lower among communities of color at 20% and Black Americans at 18%.”

2021’s Most Overweight & Obese States in America: At the “top” are West Virginia and Mississippi. See the article for the several criteria used in the rankings.

About Covid-19

Moderna requests emergency authorization for booster dose for all adults: “Moderna has submitted a request to the Food and Drug Administration (FDA) to authorize booster doses of its coronavirus vaccine for all adults, seeking to expand the number of people eligible for a third shot.”

OSHA suspends enforcement of COVID-19 vaccine mandate for businesses: “The Occupational Safety and Health Administration (OSHA) is suspending enforcement of the Biden administration’s COVID-19 vaccine mandate for large private businesses after a federal appeals court upheld a stay on it last week.”

Mutation Linked to Remdesivir Resistance Found in Covid Patient: “Yale University scientists said resistance to Gilead Sciences' antiviral Veklury (remdesivir) was found in coronavirus samples collected from an immune-compromised patient treated with the drug for a persistent COVID-19 infection, reported Bloomberg.
Similar mutations causing resistance have been generated in lab studies, but had not yet been reported in patients treated with the injectable medicine, the researchers noted.
’While the finding is limited to a single case and requires confirmation of its generalizability in larger patient populations, it suggests that [Veklury] can impart selective pressure,’ they said in a study released on the medRxiv pre-print server.”

Aetna sues COVID-19 testing company, alleging fraud: “Aetna is taking a group of related radiology companies to court and accusing them of charging at least $580,000 for unauthorized COVID-19 testing.”
According to Aetna, in spring of 2020, RP and Vestibular Diagnostics’ Open MRI opened two new companies (Universal and Integrated Wellness) as Covid-19 diagnostic facilities. Among the complaints: Aetna “claimed that the laboratory misrepresented the type of testing performed and charged a sample processing fee that only applies to PCR testing. The complaint alleges that clinicians have also escalated the claims, and some bills predate the establishment of the new company.”

COVID-19 vaccination coverage among hospital-based healthcare personnel [HCP] reported through the Department of Health and Human Services Unified Hospital Data Surveillance System, United States, January 20, 2021-September 15, 2021: “As of September 15, 2021, among 3,357,348 HCP in 2,086 facilities included in this analysis, 70.0% were fully vaccinated…
COVID-19 vaccine coverage was highest in HCP working in children's hospitals.”

About pharma

CVS to close about 900 stores over next three years, as it shifts to digital strategy: “CVS Health said Thursday that it will close about 900 stores over the next three years, as it adjusts to shoppers who are buying more online.
Shares rose 2.81% to close at $95.34. With the day’s gains, CVS shares are up about 40% this year, bringing its market value to $125.81 billion.
The company announced in a news release that it will focus more of its efforts on digital growth and turning its stores into destinations that offer a range of health-care services, from flu shots to diagnostic tests.
Store closures will begin in spring 2022. The company said it plans to close about 300 per year.”

EMA panel signals negative trend vote on Biogen, Eisai's Aduhelm: “Biogen and Eisai said Wednesday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a "negative trend vote" on a filing seeking approval of Aduhelm (aducanumab) for the treatment of Alzheimer's disease. The CHMP is expected to adopt a formal opinion on the application for the anti-amyloid antibody at its meeting next month.”

Cassava slumps on report of SEC probe: “Shares in Cassava Sciences fell as much as 25% on Wednesday after The Wall Street Journal, citing unnamed sources, said the company is facing scrutiny by the US Securities and Exchange Commission (SEC) amid allegations it manipulated data for its experimental Alzheimer's disease drug simufilam….
The allegations surfaced earlier this year when a citizen's petition asked the FDA to suspend two clinical trials of simufilam. The petition was filed by lawyer Jordan Thomas on behalf of two physicians who dispute Cassava's clinical biomarker data as well as the integrity of its western blot analysis.”

Merck & Co.'s oral PCSK9 inhibitor yields 'encouraging' early results: “Two early studies unveiled Monday at the American Heart Association's (AHA) Scientific Sessions indicate that Merck & Co.'s oral PCSK9 inhibitor MK-0616 was safe and effective at reducing high LDL cholesterol levels. The results set up the groundwork for a potential rivalry down the road with other drugs in the class, including Amgen's Repatha (evolocumab), Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab) and Novartis' long-lasting siRNA therapy Leqvio (inclisiran), all of which are currently available only by injection.”
If this drug is eventually proved to be effective, the cost of production and administration will decrease, and (depending on pricing) sales could increase dramatically.

About healthcare systems

CommonSpirit eyes sale of 14 hospitals: “Chicago-based CommonSpirit Health is in discussions to negotiate an affiliation agreement to transfer ownership of 14 Midwest hospitals, according to financial documents released Nov. 16. 
CommonSpirit said it is currently working toward an agreement with an undisclosed third party to transfer ownership of 13 critical access hospitals and one full-service tertiary hospital along with their associated clinics and home health operations. The hospitals are in North Dakota and Minnesota.”

Henry Ford Health operating income drops to $6.5M through Q3: “Henry Ford Health System, a five-hospital system based in Detroit, Mich., saw a net income of $152.5 million in the nine months ended Sept. 30, a 50.6 percent drop from the same period in 2020, according to its quarterly financial report released Nov. 15…
Total expenses in the nine months ended Sept. 30 reached $5.1 billion, a 10.5 percent increase from the same period in 2020. Henry Ford Health System saw expenses increase across several categories, including labor and supplies. Salaries, wages and employee benefits increased by $162 million year over year.”

Today's News and Commentary

About healthcare professionals

HCA to open nursing school in Virginia: “Galen College of Nursing, which is part of the HCA Healthcare network, will open a new nursing school in Richmond, Va., the organizations said Nov. 16.
This is the fourth new campus opening since Louisville, Ky.-based Galen College of Nursing joined Nashville, Tenn.-based HCA in 2020. The other new locations are in Nashville, Miami and Austin, Texas.”

About the public’s health

100,000 Americans died of drug overdoses in 12 months during the pandemic: “The U.S. drug epidemic reached another terrible milestone Wednesday when the government announced that more than 100,000 people had died of overdoses between April 2020 and April 2021. It is the first time that drug-related deaths have reached six figures in any 12-month period…
There are now more overdose deaths from the illegal syntheticopioid fentanyl than there were overdose deaths from all drugs in 2016.”
This excellent article also has international and interstate comparisons.

The Incidence of Breast Cancer Recurrence 10-32 Years after Primary Diagnosis: “Recurrences continued to occur up to 32 years after primary diagnosis. Women with high lymph node burden, large tumor size and ER-positive tumors had increased risk of late recurrence. Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches.”

About hospitals and health systems

Providence posts $311M operating loss in Q3 due to higher expenses amid COVID-19 surge: “Providence Health posted a net operating loss of $311 million for the third quarter of the year as expenses for labor and other costs soared and reimbursement didn’t keep up.
The 52-hospital system announced Monday that it generated $20.2 billion in operating revenue for the first nine months of the year, a 7% bump compared to the same period in 2020. But operating expenses soared to $20.6 billion, an increase of 8%.”

CommonSpirit's quarterly patient, premium revenue up 12.3% year over year: “CommonSpirit Health reported $34 million in operating income during the first quarter of its fiscal year, down from $167 million in the same period the year before, according to financial data (PDF) released Tuesday.
With COVID-19 provider relief stripped out of its operating income, it reported $32 million, compared to an operating loss of $25 million in the prior-year quarter.”

UCI breaks ground on $1.3B medical complex: “University of California, Irvine and UCI Health began construction on their $1.3 billion medical complex, which includes a 350,000-square-foot, 144-bed acute care hospital with an emergency room.”
Despite rising personnel expenses and challenges of decreased elective procedures, hospitals are still investing in expensive new and expanded facilities.

About health insurance

New Report Finds Value-Based Care Agreements Benefited Humana Medicare Advantage Members with Reduced Hospitalizations, More Preventive Care During COVID-19 Pandemic: “The report, comprised of data collected during 2020 and representing the challenges providers and patients experienced during the COVID-19 pandemic, reflects the outcomes and experiences of 2.65 million Humana Medicare Advantage members seeking care from 67,800 primary care physicians who are in value-based agreements.
Key Report Findings:

·       Humana VBC MA members received more care and spent less time in the hospital. Incidents of costly hospital admissions were reduced by 7% and emergency room visits by 12% for members with VBC providers compared to those with Humana non-VBC providers. On average, hospital admission rates were 22% less than Original Medicare in 2020.

·       Rates of telemedicine use for primary care rose faster in 2020 among Humana value-based MA members. During the initial wave of COVID cases, providers in VBC contracts used telehealth at five times the rate compared to practitioners in non-value-based agreements, according to a study of health maintenance organization (HMO) members between March 1-Sept. 30 by Humana Healthcare Research.

·       Humana’s VBC agreements helped reduce total medical costs by 13.4%. More preventive care and lower rates of hospitalization led to an estimated reduction in medical costs of 13.4%, or $3.1 billion that would have been incurred by value-based members had they been enrolled in Original Medicare….

·       Physicians in value-based contracts with Humana received more of the overall healthcare dollar, earning 17.5 cents of every dollar spent compared to 6.7 cents for non-value-based physicians.”

Global employer benefits costs set to rise 8.1% in 2022: Willis Towers Watson: “Employer-sponsored benefit costs are expected to rise by 8.1% on average globally for 2022, though increases vary between parts of the world, according to a new analysis from Willis Towers Watson.
The consulting firm estimates that U.S.-based benefits costs are projected to increase by 7.6%, while the highest increases are projected in Latin America, by 14.2%.”

About healthcare IT

South African company to bring health equity technologies to U.S. market: “Vantage Health Technologies, a South Africa-based company that provides cloud-based solutions for health equity challenges, is launching in the U.S.
Partnering with Microsoft, Vantage uses artificial intelligence to translate health data into actionable insights for payers, providers and government health organizations serving underserved populations.
Vantage’s platform integrates with Microsoft Teams and Outlook and is hosted on Azure, replacing health-equity-focused dashboards that require healthcare workers to run analytics and interpret the appropriate action steps themselves.”

Treatment and Follow-up Care Associated With Patient-Scheduled Primary Care Telemedicine and In-Person Visits in a Large Integrated Health System: “In this cohort study of 1 131 722 patients, adjusted rates of prescribing and nonmedication orders were significantly lower for telemedicine visits than for clinic visits, with slightly higher rates of follow-up office visits after telemedicine visits but no significant difference in rates of 7-day emergency visits or hospitalizations.
 The findings suggest that video or telephone visits may offer a convenient way to address some primary care needs within ongoing patient-physician relationships, without substantially higher rates of follow-up office visits or health events (emergency department visits or hospitalizations).”
However, the population was comprised of Kaiser patients; so extrapolation of the findings to a fee-for-service setting is not a given.

Virtual Reality for Chronic Back Pain Wins FDA Nod: “An immersive virtual reality (VR) system incorporating cognitive behavioral therapy (CBT) and other methods was approved to help treat chronic lower back pain, the FDA announced Tuesday….
The prescription EaseVRx device consists of a VR headset and controller, with a breathing amplifier attached to the headset that directs a patient's breath during deep-breathing exercises. It is intended for home-based use.
The skill-based EaseVRx program incorporates CBT principles to engage patients in pain and symptom self-management, teaching deep relaxation, attention-shifting, awareness, healthy movement, visualization, knowledge of pain and rehabilitation, and other skills. It consists of 56 VR sessions 2 to 16 minutes long, which are part of a daily 8-week treatment plan.”

Today's News and Commentary

About Covid-19

HHS withdraws Trump administration policy that limited FDA review of certain Covid-19 tests: “The Biden administration is withdrawing a policy established under the Trump administration that limited the US Food and Drug Administration's review process of certain lab tests, including some Covid-19 tests. The US Department of Health and Human Services announced the withdrawal on Monday.
Last year, the Trump administration determined that the FDA would no longer require premarket review of laboratory-developed tests, known as LDTs. Prior to that determination, laboratories were required to submit applications to develop and use their own Covid-19 tests. But the move to limit that process meant that makers of Covid-19 tests developed by certain labs -- such as Quest Diagnostics, LabCorp or those at academic medical centers -- could distribute their tests without the need to first submit documentation for review by the FDA before they were marketed.”

Biden administration to announce purchase of 10 million courses of Pfizer anti-covid pill: The Biden administration is expected to announce this week that it is purchasing 10 million courses of treatment Pfizer’s covid pill, a multibillion-dollar investment in a medication that officials hope will help change the trajectory of the pandemic by staving off many hospitalizations and deaths, according to two people with knowledge of the transaction.
U.S. officials see this antiviral pill, and another by Merck and Ridgeback Biotherapeutics, as potential game-changers to help restore a broader sense of normalcy and are eager to add them to a small arsenal of treatments for Americans who contract the coronavirus.”
In a related story: Pfizer seeks emergency authorization for its coronavirus-fighting pill regimen: Pfizer’s submission came shortly after the company announced that the clinical trial testing the drug regimen had been halted early due to overwhelming evidence that it worked. When Paxlovid was given to people at high risk of severe illness within three days of symptom onset, it reduced the rate of death and hospitalization by 89 percent compared with people given a placebo.”

12 more states challenge healthcare worker vaccination mandate: “A coalition of 12 states sued the federal government Nov. 15 to block a CMS mandate requiring COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs. 
The 12 states, led by Montana, are arguing that the mandate is at odds with the Social Security Act's focus on providing access to patient care, according to the lawsuit. They also argue that implementing the mandate exceeds the statutory authority of CMS and that the mandate violates multiple federal laws, the spending clause, the anti-commandeering doctrine, and the 10th Amendment to the U.S. Constitution…”

Disparities in COVID-19 Outcomes by Race, Ethnicity, and Socioeconomic Status: A Systematic-Review and Meta-analysisIn this systematic review and meta-analysis of 4.3 million patients from 68 studies, African American, Hispanic, and Asian American individuals had a higher risk of COVID-19 positivity and ICU admission but lower mortality rates than White individuals. Socioeconomic disparity and clinical care quality were associated with COVID-19 mortality and incidence in racial and ethnic minority groups.”

About health insurance

Automatic MIPS Participation Exemption for Individual Eligible Clinicians: CMS is exempting all individual eligible clinicians from Merit-Based Incentive Payment System (MIPS) participation in the 2021 performance year (PY). The eligible clinicians will receive an automatic neutral payment adjustment for the 2023 MIPS payment year, the agency recently announced via email.
The email sent to the CMS Quality Payment Program listserv said CMS is applying the automatic extreme and uncontrollable circumstances (EUC) policy because of the ongoing COVID-19 pandemic. CMS also applied the EUC policy last year to individually eligible clinicians participating in MIPS during PY 2020. The clinicians will also receive a neutral payment adjustment in the 2022 MIPS payment year.”

Amazon Care has a new customer: Hilton : “Hilton's U.S. employees who are enrolled in a corporate health plan will have access to Amazon Care in 2022, an Amazon…
Hilton employees will have free access to text chats with Amazon Care, while video or home visits with providers will carry a small fee…”

Payers earn Dow Jones sustainability recognition: “In 2021, five payers — Cigna, CVS Health, Anthem, Humana and UnitedHealth Group — made the international yearbook for their sustainability efforts. Cigna earned a top Global Gold Class honor while CVS Health earned both Global Silver Class and Global Industry Movers honors.”

Biden-Harris Administration Announces Medicare Fee-For-Service Estimated Improper Payments Decline by Over $20 Billion Since 2014 “Improper payments are payments that do not meet CMS program requirements. Improper payments can be overpayments or underpayments, or payments where insufficient information was provided to determine whether a payment is proper or not. Most improper payments involve situations where a state or provider missed an administrative step. While fraud and abuse may lead to improper payments, it is important to note that the vast majority of improper payments do not constitute fraud, and improper payment estimates are not fraud rate estimates.”
However, the improper payment rate is still about 7% or about $25B per year!

About hospitals and health systems

Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities (Revised): From CMS:Hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services. 
All co-located hospitals must demonstrate independent compliance with the hospital CoPs. This guidance clarifies how hospitals may organize shared spaces, services, personnel, and emergency services to meet regulatory requirements. When hospitals choose to co-locate, they should consider the risk to compliance through any shared space or shared service arrangements.”

Viewing 312 systems ranked by Cost EfficiencyFrom the Lown Insitute. See this site for a ranked list and search engine.

About healthcare IT

8 reasons patients are resistant to telehealthDuring August and September, GoodRx surveyed 1,042 patients about their telehealth experiences. Among the patients who had never used telehealth, here are…
[the top 3] reasons they cited:

1.    No health issues that have required a telehealth visit: 62 percent

2.    Preference for face-to-face visits: 36 percent

3.    Lack of familiarity with telehealth: 25 percent”

The effectiveness of digital interventions for increasing physical activity in individuals of low socioeconomic status: a systematic review and meta-analysis: “Digital interventions targeting PA [physical activity] do not show equivalent efficacy for people of low and high SES. For people of low SES, there is no evidence that digital PA interventions are effective, irrespective of the behaviour change techniques used. In contrast, the same interventions in high SES participants do indicate effectiveness. To reduce inequalities and improve effectiveness, future development of digital interventions aimed at improving PA must make more effort to meet the needs of low SES people within the target population.”

About healthcare professionals

Surgicalists: Why Aren’t They In Your Hospital? Yet another way to fragment care or more akin to other full-time, hospital-based physicians (like pathology, radiology and anesthesiology)?
”Surgicalists are providers who are dedicated to a single hospital. They do not float between facilities like locum tenens. They serve on committees, engage with the community at large, and work side-by-side with hospital employees as a true team. Surgicalists are assigned regular shifts and are paid on a per diem basis as independent contractors.”

About the public’s health

The 'threat multiplier' healthcare leaders can't afford to ignore: “Research suggests the United States is the highest contributor to the global healthcare climate footprint. The healthcare industry accounts for 8.5 percent of all greenhouse gas emissions in the U.S.. Worldwide, the healthcare industry is responsible for 4.4 percent of net emissions, which is the equivalent of 514 coal-fired power plants, according to a 2019 report from Arup and Health Care Without Harm…
The medical supply chain accounts for 71 percent of healthcare's carbon footprint. Excess waste is created from plastic gloves, surgical supplies, medicine containers and gowns, among other materials. If the American healthcare sector were its own country, it would be the 13th largest source of greenhouse gas emissions in the world…”

Health at a Glance 2021The OECD just published its updated health statistics. It is the single best source for this international data.

Multivitamins, but Not Cocoa, Tied to Slowed Brain Aging: Taking a daily multivitamin for 3 years is associated with a 60% slowing of cognitive aging, with the effects especially pronounced in patients with cardiovascular (CVD) disease, new research suggests.
In addition to testing the effect of a daily multivitamin on cognition the COSMOS-Mind study also examined the effect of cocoa flavanols, but showed no beneficial effect.”

About healthcare devices

TecTraum’s pro2cool Concussion Treatment Designated a Breakthrough Device: “The noninvasive hypothermic therapy device is designed to reduce the severity of concussion symptoms and allow patients to recover more quickly.   
The device provides localized cooling for the head and neck to lower blood temperature before it enters the brain. Research has shown that cooling the brain within days of a concussion significantly improves clinical outcomes, the company said.”

About pharma

AbbVie's 'unsupported' price hikes on Humira drove $1.4B in extra U.S. drug spending, ICER says: Over the years, the Institute for Clinical and Economic Review (ICER) has emerged as a champion in the fight against high U.S. drug costs. In its third report on unsupported price increases (UPI), the Institute is taking aim at seven meds that it argues have gone up in price without justification from new data.
Among the group, AbbVie's prolific rheumatoid arthritis med Humira drove the largest increase in U.S. drug spending, according to a report released Tuesday. Novartis' Promacta and Biogen's Tysabri clinched the no. 2 and no. 3 spots, respectively. Elsewhere, drugs from Bausch Health, Supernus Pharmaceuticals and Horizon Pharmaceuticals made the list. In addition, another AbbVie med ranked near the bottom of the list.

Today's News and Commentary

About health insurance

Oscar Health Announces Results for Third Quarter 2021: Disturbing trends, especially compared to other insurers’ financials reported here last week. Despite increased membership and premiums, the MLR and net loss increased.

  • “Membership as of September 30, 2021 of 594,284, a 41% increase YoY

  • For the quarter ended September 30, 2021:

    • Direct policy premiums of $895.4 million, a 53.1% increase YoY

    • Premiums earned of $441.7 million, a 345.6% increase YoY

    • Medical Loss Ratio of 99.7%, increased 920 bps YoY

    • InsuranceCo Administrative Expense Ratio of 23.1%, increased 70 bps YoY

    • InsuranceCo Combined Ratio of 122.8%, increased 990 bps YoY

    • Net loss of $212.7 million, an increase of $133.6 million YoY; Adjusted EBITDA loss of $188.7 million, an increase of $117.7 million YoY”

2022 Medicare Parts A & B Premiums and Deductibles/2022 Medicare Part D Income-Related Monthly Adjustment Amounts: CMS says Part B increases will be more than offset by the increased Social Security payments (as if healthcare is the only increased expense facing seniors). One unique item in this year’s explanation of why rates are increasing: “Additional contingency reserves due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm™…” At $56k per year, the drug’s sales have been slow, but future unknown costs forced CMS to be prepared for huge future expenses. Some estimate that about half of the 14.5% increase in Part B premiums are due to this cost uncertainty. See, also: Alzheimer’s drug cited as Medicare premium jumps by $21.60

Healthcare Affordability: Majority of Adults Support Significant Changes to the Health System: From the RWJ Foundation:
Some highlights:
- “Put limits on what drug companies can charge for specific drugs that save lives or that millions of people use to treat life-long health conditions like diabetes. (89%)

- Prevent drug companies from blocking cheaper generic drugs from being sold in the US. (86%)

- Put limits on the prices that hospitals can charge for services. (85%)

- Allow the government to negotiate lower drug prices for employers and consumers. (84%)

- Put limits on the prices that doctors can charge for services. (81%)

- Eliminate health insurance deductibles and copayments so that people don't have to pay more to use their health insurance. (80%)” One question not asked was whether respondents would rather higher premiums or narrower networks in exchange for a reduction in out-of-pocket expenses.

Former UnitedHealth exec says company would only pay surprise bills after complaints: “The former head of UnitedHealthcare's Shared Savings Program alleged during testimony that the insurer was willing to pay for its members' surprise medical bills, but only if they filed a complaint to the company. 
The testimony is part of the ongoing legal battles between UnitedHealthcare and TeamHealth. John Haben, the former UnitedHealthcare executive, has been testifying in Nevada over a TeamHealth lawsuit that alleges the insurer's Shared Savings Program resulted in millions of dollars in clinician underpayments.”

About Covid-19

U.S. appeals court affirms hold on Biden COVID-19 vaccine mandate: “A U.S. appeals court on Friday upheld its decision to put on hold an order by President Joe Biden for companies with 100 workers or more to require COVID-19 vaccines, rejecting a challenge by his administration.”

About pharma

CVS withdraws Supreme Court case on disability rights, announces new partnership: “The CVS pharmacy chain has reached an agreement with a coalition of disability rights organizations and dropped a legal case that had made it all the way to the U.S. Supreme Court. The court was scheduled to hear arguments in the dispute next month, and the ruling could have had far-reaching effects on disability rights
The case, CVS Pharmacy, Inc. vs. Doe, stemmed from a lawsuit filed against CVS by multiple people who take prescription drugs for HIV/AIDS. The plaintiffs objected to changes to the company's terms that meant they could not opt out of mail-only delivery or utilize another pharmacy with experience handling their special medication needs. They argued it had a discriminatory impact on them, even if that wasn't the company's intent.”
Since the Supreme Court did not have a chance to rule in this case, the issue of the ability of an insurance company to impose a narrow network is unresolved.

About healthcare devices

FDA flags safety issue in replacement material for recalled Philips ventilators: “Months after Philips received the FDA’s go-ahead to begin repairing and replacing the ventilators affected by the Class I recall the company initiated in mid-June, the regulator identified a potential safety risk with a replacement component, according to a Nov. 12 statement.
The recall was sparked by an issue Philips identified with the polyester-based polyurethane foam used to muffle sound and vibrations in its continuous and non-continuous ventilators. Over time, the company found, that foam could break down, potentially sending specks of black debris and other dangerous toxins into the air pathway.”

Today's News and Commentary

About the public’s health

Lifestyle changes could save $92,000 in medical costs per person: “The study examined four individual patient cases of disease reversal achieved through intensive lifestyle changes and the associated reduction in health care costs. A substantial potential cost savings for both the patients and their insurance providers was identified in each case. For an adult male who lost up to 200 pounds after committing to a lifestyle change for six months, the potential savings in avoided discrete medical costs reached $92,000.”

Cervical Cancer Screening Guideline for Individuals at Average Risk: Cervical Cancer Screening for Individuals at Average Risk: 2020 Guideline Update From the American Cancer Society:
Major recommendations:

  • Begin screening at age 25 years regardless of sexual history or HPV vaccination status (strong recommendation) [Increased from age 21]

  • Primary HPV testing every 5 years through age 65 years (strong recommendation) [Increased testing every five years from 3 years.]

  • If primary HPV testing is not available use cotesting (HPV+ cytology) every 5 years or every 3 years if cytology only (strong recommendation)

  • Discontinue screening at age 65 years if no history of cervical intraepithelial neoplasia grade 2 or more severe diagnosis in last 25 years and adequate negative prior screening in last 10 years (qualified recommendation)”

The High Costs of Maternal Morbidity Show Why We Need Greater Investment in Maternal Health: “We identified evidence to support connections between nine maternal morbidity conditions, such as hypertensive disorders, and 24 maternal and child outcomes, such as cesarean section delivery and preterm birth. We estimated total maternal morbidity costs for all U.S. births in 2019 to be $32.3 billion from conception through the child’s fifth birthday. This amounts to $8,624 in additional costs to society for each maternal–child pair.”

About pharma

Johnson & Johnson will break itself into two companies.: “Johnson & Johnson said on Friday that it would break itself into two publicly traded companies…
The 135-year-old company, which employs more than 136,000 people, announced that it planned to spin off its consumer-products division — home to Tylenol, Band-Aid, Neutrogena beauty products and more — into a separate business.
That would leave J.&J. with its pharmaceutical and medical devices division, which includes its coronavirus vaccine manufacturing and boasts faster-growing sales and higher margins.”

Keeping the 100-year-old promise:making insulin access universal: From the WHO:
”In 1921, researchers at the University of Toronto discovered insulin, which changedthe diabetes narrative forever. In keeping with a promise that insulin ‘belongs to the world’, the patent was sold for just one Canadian dollar.” Prices had been affordable with increased production. But more recently, analogue insulins have replaced human insulin and prices have skyrocketed. The result is that about 30 million people worldwide who need insulin do not have access to it.
This monograph offers an excellent examination of what is wrong and how access can be improved.

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties: “President Biden on Friday is expected to nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, several people familiar with the planning said. The move would end nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.
In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.”

Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements: “Through an ongoing Freedom of Information Act–based investigation, all 58 Pre-Notices that the FDA issued from 2013 through April 29, 2021, were obtained. Of these, 57 described potential missing trial results information and 1 described missing registration information.”
The authors recommend several measures that the FDA can use to make sure companies comply with reporting requirements.

About Covid-19

Booster shots are most popular in poorly vaccinated states where coronavirus rages: “The rate at which fully vaccinated residents are getting the shots is highest in the states that also have high rates of new coronavirus cases, including Alaska, North Dakota and Montana, according to a review of state data by The Washington Post. In swaths of the country where health officials will not impose mask and vaccine mandates to curb the virus’s spread, or have had their powers stripped away by Republican state lawmakers or governors, boosters are one of the few shields left for those worried about contracting and spreading the virus.”

AstraZeneca to take profits from Covid vaccine sales: “AstraZeneca has signed its first for-profit deals for its Covid-19 vaccine, moving away from the completely non-profit model that it used during the pandemic. The Anglo-Swedish drugmaker is now expecting the vaccine will move to ‘modest profitability’ as new orders are received. The shot, developed with the University of Oxford, will remain non-profit for developing countries. AstraZeneca committed to selling the vaccine ‘at cost’ for the duration of the pandemic, as part of its agreement with Oxford.”

About health insurance

6 national payers ranked by Q3 profits: A good summary with links to each company for further information.
All were profitable.

New Spending from Filling the Medicaid Coverage Gap Outweighs Cuts in Disproportionate Share Payments: From the Urban Institute: “This paper provides estimates of the increase in federal subsidies under two provisions of the Build Back Better Act (BBBA) that would flow to people below the federal poverty limit in the 12 states that have not expanded Medicaid (people in the “Medicaid gap”). These subsidies are compared to the cuts in federal DSH payments also proposed in the bill. We estimate that in a year when Medicaid gap subsidies are provided, hospitals in the 12 nonexpansion states would see more than $6.8 billion in new spending for people in the Medicaid gap as a result of the coverage expansions, about 15 times larger than the expected DSH cuts of $444 million. Overall new federal health subsidies for people in the Medicaid gap going to nonexpansion states would be more than $19 billion.”
Two related papers: How would filling the Medicaid “coverage gap” affect hospital finances? from Brookings/USC Schaeffer Center which reaches similar conclusions and an opposing critiques from the AHA: Brookings paper misses the point on Medicaid DSH cuts included in BBBA

CMS nixes Medicare coverage of breakthrough medical devices: 4 things to know: “CMS said Nov. 12 it will rescind a rule introduced by former President Donald Trump's administration that allows Medicare to quickly cover medical devices deemed ‘breakthrough' technologies by the FDA…
CMS said it will rescind the rule because of concerns over Medicare patient safety.
’Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,’ CMS Administrator Chiquita Brooks-LaSure said…”

About healthcare IT

FCC grants $709M to improve rural broadband access: “The Federal Communications Commission on Nov. 10 announced the fourth round of funding for its Rural Digital Opportunity Fund, awarding $709 million to support the development of high-speed broadband networks for more than 10 million Americans who live in rural areas.”

About healthcare financing

US doctors fear patients at risk as cost cuts follow private equity deals: A concerning expose from The Financial Times concerning cuts in clinical care due to private equity firms reducing expenses in their new healthcare investments.
”Private equity groups have poured money into US healthcare in recent years, as they see opportunity in an ageing society that spends more than ever on staying healthy. According to a report by Richard Scheffler at the University of California, Berkeley, and Laura Alexander at the American Antitrust Institute, annual private equity healthcare deals soared from an estimated $42bn in 2010 to $120bn in 2019, before dipping to $96bn in 2020.”

Today's News and Commentary

About Covid-19

Federal judge overrules Texas ban on mask mandates in schools: “A federal judge ruled Wednesday that Texas Gov. Greg Abbott’s (R) ban on mask mandates in schools violates the Americans With Disabilities Act, a decision that could have national implications as several other states are embroiled in legal battles over face covering requirements for children…
Disability Rights Texas, an advocacy group, challenged the Republican governor’s ban in August, arguing that it discriminates against students with disabilities — many of whom have health conditions that put them at greater risk for severe illness or death — by forcing them to risk exposure to the coronavirus or stay home from school.”
While Texas state officials are trying to prevent disease-controlling measures: Unvaccinated 20 times more likely to die from COVID-19: Texas study: “A Texas government study found that unvaccinated people were 20 times more likely to die of COVID-19 than the fully vaccinated throughout most of September, providing further evidence backing the vaccines. 
The research, published by the Texas Department of State Health Services on Monday, determined that 81.3 percent of COVID-19-related deaths between Sept. 4 and Oct. 1 occurred among unvaccinated people. In comparison, 5 percent of these fatalities occurred among the partially vaccinated, and 13.7 percent involved fully vaccinated patients. 
In that time period, unvaccinated individuals in their 40s were 55 times more likely to die from COVID-19 than others who were the same age and fully vaccinated. Among those aged 75 and older, the unvaccinated were 12 times more likely to die.”

States challenge Biden’s vaccine mandate for health workers: “The lawsuit filed in a federal court in Missouri contends that the vaccine requirement threatens the jobs of millions of health care workers and could “exacerbate an alarming shortage” in health care fields, particularly in rural areas where some health workers have been hesitant to get the shots…
Joining the lawsuit were the attorneys general of Alaska, Arkansas, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. All are Republicans except for Democratic Attorney General Tom Miller of Iowa, whose state is led by Republican Gov. Kim Reynolds.”

Home virus tests recalled over false positives reach 2 million kits.: “The Australian company Ellume has expanded a recall of its at-home coronavirus test because of concerns about a ‘higher-than-acceptable’ rate of false positives, the U.S. Food and Drug Administration said on Tuesday.
The recall now includes roughly two million of the 3.5 million test kits that Ellume had shipped to the United States by last month, a substantial increase from the company’s earlier estimate that about 427,000 of those kits were potentially faulty.
It is not clear how many false positives the affected tests have yielded. The issue, which the company had previously traced to a problem with one of the raw materials used in its test kits, does not affect the reliability of negative results.”

About health insurance

2021 Employer Health Benefits Survey: This annual KFF study is the best single source of information on employer-sponsored insurance. While there are many valuable details in the chapters, the overall message in the press today is: “In 2021, the average annual premiums for employer-sponsored health insurance are $7,739 for single coverage and $22,221 for family coverage. The average single and family premiums increased 4% over the past year. During this period, workers’ wages increased 5% and inflation increased 1.9%.
The average premium for family coverage has increased 22% over the last five years and 47% over the last ten years.”

TransUnion Healthcare: 2021 Sees 55% Rise in Financial Assistance Transactions: “The number of financial assistance transactions processed by TransUnion Healthcare increased 55% between September 2020 and September 2021. A new analysis from TransUnion Healthcare (NYSE: TRU) released at the HFMA Annual Conference indicates hospitals are more proactively working with patients to understand their financial needs and provide them appropriate options…
While the increased number of financial assistance transactions was likely exacerbated by the economic downturn caused by the pandemic… other factors, like hospital billing practices also played a role.”

About pharma

Current and Resolved Drug Shortages and Discontinuations Reported to FDA: The total list has 156 entries, many of which are highly-used drugs, e.g., cefazolin, cefotaxime, dexamethasone, digoxin, dobutamine, and epinephrine. Those medications are just the A through E entries!

Doctor Who Distributed Unapproved Cancer Treatment Drug Convicted of More Than Two Dozen Felony Charges: “A physician has been found guilty of 26 felony charges for fraudulently distributing an unapproved cancer treatment over a six-year period, charging up to $2,000 per bottle, the Justice Department announced today.
Benedict Liao, 81, a.k.a. ‘Wada Masao,’ and ‘Masao A. Wada,’ of Fullerton, was found guilty on Tuesday afternoon of seven counts of wire fraud, 11 counts of selling a misbranded drug and eight counts of selling an unapproved new drug…
From July 2012 through June 2014, Liao sold and distributed Allesgen at a price generally set at $2,000 per bottle, plus shipping, to customers in various states and in foreign countries, because of which he received at least approximately $850,000 in revenue. From approximately July 2014 through January 2018, Liao continued to sell and distribute additional bottles of Allesgen to customers in various states and in foreign countries, as a result of which he received additional revenue totaling approximately $765,000.”
How was he able to sell this substance for 6 years?

Vizient Calls on Industry Stakeholders to Join Alliance to End Drug Shortages: “Vizient, Inc….announced the formation of a new alliance to end drug shortages in the U.S. The End Drug Shortages Alliance will provide a forum for key stakeholders across the industry to take strategic aim at one of the health care industry’s most pressing and enduring issues.
Vizient, which connects more than half the nation's health care organizations to pharmaceutical suppliers through its contracting services, monitors more than $80 billion in pharmaceutical spend across all classes for trade. In 2019, a Vizient member survey revealed that managing drug shortages costs U.S. hospitals more than $359 million annually in labor alone.”

FDA Issues Nearly 50 Product-Specific Guidances for Generics Producer: ““The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications” (ANDAs), said the agency in a Federal Register notice published Tuesday.
Of the new and updated draft PSGs released, 13 guidances pertain to complex generic products, covering products with a complex active ingredient, formulation, route of delivery or dosage form. And more PSGs on complex generics are expected soon. On its website, the agency lists a further 69 complex generics set to receive draft guidances.”

About hospitals and health systems

100 of the largest hospitals and health systems in America | 2021: FYI

About healthcare quality

Addressing health care disparities by improving quality and safety: A new policy statement from the Joint Commission. Accreditation requirements are listed on page 7.

About healthcare devices

A decade retrospective of medical robotics research from 2010 to 2020: An excellent review of the topic.
A useful overview of the conclusions (with references left in the text): “Although the field cannot yet point to comprehensive clinical trials that show that robotic surgical procedures provide improved procedural outcomes for patients (70) or reduced procedure cost compared with nonrobotic surgery (71), a number of patient benefits have been demonstrated. These include shorter hospital stays, faster recuperation, fewer reoperations, and reduced blood transfusions (71). For surgeons, robots provide improved ergonomics, leading to reductions in neck and back pain (72) as well as hand and wrist numbness (73) with less physical and mental stress compared with direct hand-controlled procedures (74). These factors increase a surgeon’s quality of life and could potentially lengthen their career. Studies have also shown that robotics can markedly reduce radiation exposure to both the surgeon and the patient (75).”



Today's News and Commentary

About health insurance

Association of Participation in the Oncology Care Model [OCM] With Medicare Payments, Utilization, Care Delivery, and Quality Outcomes: “In its first 3 years, the OCM was significantly associated with modestly lower Medicare episode payments that did not offset model payments to participating practices, and there were no significant differences in most utilization, quality, or patient experience outcomes.”
See, also, the accompanying editorial: Medicare Spending, Utilization, and Quality in the Oncology Care Model, which raises some good policy questions.

Whistleblower alleges Aetna used dead, out-of-state physicians to bolster network: “A recently unsealed whistleblower lawsuit out of Philadelphia accuses Aetna of assigning children under Medicaid to providers who were dead, out of state or did not specialize in pediatrics.”

Georgia ASCs, anesthesia providers to pay $28M to resolve kickback allegations: “Three anesthesia providers and several Georgia ASCs, along with their physician-owners and an administrator, agreed to pay more than $28 million to resolve allegations that they entered kickback agreements…
The suit alleges that Ambulatory Anesthesia of Atlanta and Northside Anesthesiology Consultants, both in Atlanta, paid a number of ASCs for medications, supplies, equipment and labor in exchange for patient referrals between 2005 and 2015.”

Clover Health Reports Third Quarter 2021 Financial Results: The company provides an interesting case study. The Medical Loss Ratio is still high as the company has rapidly expanded. It blames Covid-19 rebound of deferred care for the increase costs, but other companies are not reporting such numbers.

About Covid-19

U.S. government to buy $1 billion more worth of Merck's COVID-19 pill: “The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc  and partner Ridgeback Biotherapeutics, the companies said on Tuesday.
The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.”

WHO warns of shortage of 1 to 2 billion COVID-19 vaccine syringes: “There could be a shortage of one to two billion syringes needed to administer COVID-19 vaccinations in 2022 which could also impact routine immunisations and undermine needle safety, the World Health Organization warned on Tuesday…”

Moderna took NIH money and help for its covid vaccine. Now it wants to leave government scientists off a lucrative patent.: “Moderna is disputing some claims by the National Institutes of Health that it was behind the invention of the company’s mRNA coronavirus vaccine, raising the stakes in the debate over the government’s ability to exert influence over the availability and price of the vaccine in the future.
At the core of the dispute is the contribution of NIH-funded scientists who worked closely with Moderna at the dawn of the pandemic to develop the groundbreaking vaccine.
The dispute was revealed in patent applications filed by Moderna that were reviewed by researchers for the consumer advocacy group Public Citizen.
Some of Moderna’s applications excluded government-funded scientists.”

Surgeon general releases guide to combating COVID-19 vaccine misinformation: See the article for the illustrated “toolkit” to be used to combat misinformation.

Association of Self-reported COVID-19 Infection and SARS-CoV-2 Serology Test Results With Persistent Physical Symptoms Among French Adults During the COVID-19 Pandemic: “In this cross-sectional analysis of 26 823 adults from the population-based French CONSTANCES cohort during the COVID-19 pandemic, self-reported COVID-19 infection was associated with most persistent physical symptoms, whereas laboratory-confirmed COVID-19 infection was associated only with anosmia. Those associations were independent from self-rated health or depressive symptoms.
Findings suggest that persistent physical symptoms after COVID-19 infection should not be automatically ascribed to SARS-CoV-2; a complete medical evaluation may be needed to prevent erroneously attributing symptoms to the virus.”

Express Scripts Creates Industry-First Solution to Provide Coverage for At-Home COVID-19 Test Kits : “Beginning January 1, 2022, members of plans who enroll in this Express Scripts solution can visit a participating in-network pharmacy, choose an applicable COVID-19 OTC test kit, and show their Express Scripts member ID card at checkout to process the kit through their pharmacy benefit. Plans have the flexibility to set the member copay for the tests, either at a discounted rate or $0 copay.”

About the public’s health

Accelerometer-derived sleep onset timing and cardiovascular disease incidence: a UK Biobank cohort study : ”Growing evidence suggests that poor sleep health is associated with cardiovascular risk. However, research in this area often relies upon recollection dependent questionnaires or diaries. Accelerometers provide an alternative tool for measuring sleep parameters objectively…
An age- and sex-controlled base analysis found that sleep onset time of 10:00 p.m.–10:59 p.m. was associated with the lowest CVD incidence…
Importantly, sensitivity analyses revealed this association with increased CVD risk was stronger in females…”

Type of fat, not how much, linked to stroke risk, study finds: “The study found that eating more animal fat was linked to a higher risk of stroke, while getting more fat from vegetable sources was linked to a lower risk…
The results come from 27 years of data from more than 117,000 health care professionals. The data were pulled from two of the largest and longest-running nutritional studies in the U.S. — the Nurses’ Health Study and the Health Professionals Follow-Up Study.”

Adults Who Report Fair or Poor Health Status by Race/Ethnicity: The report is based on 2020 data and should be cautiously interpreted; self-reported data does not often correlate well with objective data. The poorest health reported is Puerto Rico, followed by West Virginia. The best reported health is in D.C., followed by Massachusetts.

About healthcare devices

FDA clears AFib notification on Apple Watch: “If the irregular rhythm consistent with AFib is identified and confirmed, IRNF 2.0 Watch app will notify the user and transfer the AFib notification to the iPhone Health App through Apple’s HealthKit sync. It will encourage the user to seek medical care. The app will display a history of all prior AFib notifications and allow the user to view a list of times for the irregular rhythms contributing to the notification.”

FDA Designates ReWalk’s ReBoot Soft Exo-Suit a Breakthrough Device: “ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in people with reduced ankle function related to neurological injuries, such as stroke. It works in conjunction with the muscles of the affected leg to assist with maintaining safe foot positioning and with pushing off the ground, which means it may improve users’ gait.”

GE Plans to Form Three Public Companies Focused on Growth Sectors of Aviation, Healthcare, and Energy: “GE Aviation, GE Healthcare, and the combined GE Renewable Energy, GE Power, and GE Digital businesses [are] to become three industry-leading, global, investment-grade public companies…”
GE Healthcare will be a tax-free spinoff, “creating a pure-play company at the center of precision health in early 2023, in which GE expects to retain a stake of 19.9 percent…”

About pharma

Sun Pharma Agrees to $85 Million in Settlements Over Price-Fixing Allegations: “Two U.S. subsidiaries of Indian generics company Sun Pharmaceutical Industries have reached settlements totaling $85 million with plaintiffs in the companies’ drug-pricing antitrust litigation, said Sun in a statement…
From 2013 to 2015, according to the U.S. Department of Justice, Taro Pharmaceuticals USA, Sandoz and Apotex are alleged to have conspired to set prices on a number of popular unnamed generic drugs. The companies are alleged to have paid each other — and other unnamed companies — to manipulate price, supply and customer allocations between 2013 and 2015.”

AstraZeneca to set up division for vaccines and antibody therapies: The headline is the story.

About hospitals and health systems

Record Number of Hospitals Receive an ‘A,’ ‘B,’ ‘C,’ ‘D,’ or ‘F’ on the Leapfrog Hospital Safety Grade: Published today on the Leapfrog website. Highlights:

  • “Thirty-two percent of hospitals received an "A," 26% received a "B," 35% received a "C," 7% received a "D," and less than 1% received an "F.”

  • The five states with the highest percentages of "A" hospitals are Virginia, North Carolina, Idaho, Massachusetts, and Colorado.

  • There were no "A" hospitals in Delaware, Washington, DC, and North Dakota.”

About medical groups

Justice Department probing Oak Street Health for potential false claims violations: “The Justice Department is investigating Oak Street Health, a Chicago-based network of primary care centers for Medicare beneficiaries, over potential False Claims Act violations, according to a filing the company submitted to the Securities and Exchange Commission.  
The Justice Department requested a civil investigative demand from the company on Nov. 1. It is requesting documents and information related to Oak Street Health's relationships with third-party marketing agents and its service offering free rides to Medicare beneficiaries.”
Offering “free” services to Medicare recipients can lead to charges of illegal inducements. Medicare Advantage companies have received federal permission to offer many non-traditional services; however, Oak Street is a provider and may not fall under those permissions.

Today's News and Commentary

About Covid-19

White House tells businesses to proceed with vaccine mandate despite court-ordered pause: “The White House on Monday said businesses should move forward with President Joe Biden’s vaccine and testing requirements for private businesses, despite a federal appeals court ordering a temporary halt to the rules.”

How protein-based COVID vaccines could change the pandemic: “Unlike the relatively new technologies that the mRNA and viral-vector COVID-19 shots are based on, protein vaccines have been used for decades to protect people from hepatitis, shingles and other viral infections. To elicit a protective immune response, these shots deliver proteins, along with immunity-stimulating adjuvants, directly to a person’s cells, rather than a fragment of genetic code that the cells must read to synthesize the proteins themselves.
Although protein vaccines are not yet in widespread use for COVID-19, late-stage clinical-trial data so far look promising, demonstrating strong protection with fewer side effects than other COVID-19 shots typically cause.”

Rite Aid to make vaccine sign-up site accessible after DOJ intervenes: “The DOJ said in a release Monday that the site’s calendar didn’t show screen reader users any available appointment times, and those who use the tab key instead of a mouse couldn’t complete the required consent form.
The agreement also alleged the site included some text and links with low color contrast, introducing difficulties for individuals with low vision.”

Qiagen Gets CE Mark for COVID-19, Influenza A and B, RSV Test: “Qiagen has received the CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test, which runs on the company’s QIAstat-Dx system.
The test is intended to quickly identify whether patients have common seasonal respiratory infections or COVID-19…”

OVID-19 Misinformation is Ubiquitous: 78% of the Public Believes or is Unsure About At Least One False Statement, and Nearly a Third Believe At Least Four of Eight False Statements Tested: A fascinating article about misconceptions. One very interesting finding is beliefs by news source:
”People’s trusted news sources are correlated with their belief in COVID-19 misinformation. At least a third of those who trust information from CNN, MSNBC, network news, NPR, and local television news do not believe any of the eight false statements, while small shares (between 11% and 16%) believe or are unsure about at least four of the eight false statements.
Larger shares of those who trust COVID-19 information from leading conservative news sources believe misinformation, with nearly 4 in 10 of those who trust Fox News (36%) and One America News (37%), and nearly half (46%) of those who trust Newsmax, saying they believe or are unsure about at least half of the eight false statements.”

Pfizer-BioNTech expected to seek authorization for coronavirus booster for people 18 and older: “The request, which may be filed as soon as this week, is likely to win the backing of the Food and Drug Administration, said the individuals, who spoke on the condition of anonymity because they were not authorized to discuss the issue. That would essentially fulfill the Biden administration’s booster-for-all-adults goal, announced last August amid concerns about waning vaccine protection.”

About pharma

Purdue Agrees Not To Finalize Ch. 11 Plan Until Appeals Done: “A New York bankruptcy judge said Tuesday that a stay of the implementation of Purdue Pharma's Chapter 11 plan pending appeals was unnecessary after Purdue agreed not to take the plan's final steps until after the first round of appeals are decided.”

Drugmakers get mixed bag in lawsuit rulings over 340B contract pharmacy moves: “A federal judge found drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies.
But a separate ruling found that manufacturers don’t have to provide discounts.
The opinions, released late Friday, are the latest in a legal fight between six drugmakers and the Biden administration over whether they must offer discounted products to contract pharmacies. Federal judges issued separate rulings in lawsuits filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics.
The lawsuits were filed in response to Health Resources and Services Administration’s (HRSA's) decision in May to warn the six drugmakers—Eli Lilly, Sanofi, United Therapeutics, Novartis, AstraZeneca and Novo Nordisk—to walk back the restrictions imposed in summer 2020.”

Merck Announces Receipt of Antitrust Clearance in Germany and Austria Relating to Tender Offer to Acquire Acceleron Pharma Inc.: The SEC still needs to give final clearance.

Oklahoma Court Overturns $465M Opioid Ruling Against J&J: “The Oklahoma Supreme Court on Tuesday overturned a $465 million opioid ruling against drugmaker Johnson & Johnson, finding that a lower court wrongly interpreted the state's public nuisance law.
The court ruled in a 5-1 decision that the district court in 2019 was wrong to find that New Jersey-based J&J violated the state’s public nuisance statute. It also rejected the state’s appeal to increase the damage award.”

Unsealed Emails Show How J&J Shaped Report on Talc's Links to Cancer: “Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer.
The emails -- unsealed in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders’ health risks. They also show the researchers changed the final version of their report at the companies’ behest.
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.”

About hospitals and health systems

10 Years of Hospital Readmissions Penalties: “Over the lifetime of the program, 2,920 hospitals have been penalized at least once. That’s 93% of the 3,139 general acute hospitals subject to HRRP [Hospital Readmission Reduction Program] evaluation, and 55% of all hospitals. Moreover, 1,288 have been punished in all 10 years. Only 219 eligible hospitals have avoided any payment reductions since the program’s start in 2013, though more than 2,000 hospitals are automatically exempt from penalties because they have specialized functions: those that focus on children, psychiatric patients, veterans, rehabilitation and long-term care or those that serve as the only hospital in an area.”

Tenet and USPI to Acquire SurgCenter Development and Establish Long-Term Development Partnership:
“Tenet Healthcare Corporation (NYSE: THC), and its subsidiary United Surgical Partners International (USPI), today announced that they have entered into a definitive agreement with the principals of SurgCenter Development (SCD) to acquire SCD. Under the terms of the agreement, Tenet/USPI will acquire SCD’s ownership interests in 92 ambulatory surgery centers (ASCs) and other related ambulatory support services (collectively, the Portfolio).
USPI and SCD’s principals will also enter into a five-year partnership and development agreement designed to provide seamless continuity and support for SCD’s facilities and physician partners over the coming years. Going forward, USPI also has the exclusive option to partner with SCD on de novo development projects over the life of the agreement…
Tenet/USPI will acquire SCD’s ownership interests in 92 ASCs and related ambulatory support services for approximately $1.2 billion.”

25 attorneys general urge court to block New Jersey hospital merger: This action highlights the national attention hospital mergers are receiving.
“California Attorney General Rob Bonta and Pennsylvania Attorney General Josh Shapiro are leading the multistate coalition that is urging an appeals court to keep intact the Aug. 4 decision by the U.S. District Court for the District of New Jersey to grant a preliminary injunction blocking the merger. 
In its decision, the district court said the merger would result in anticompetitive effects like higher prices and lower-quality care. Less than a month after the court's decision, Hackensack Meridian and Englewood Health filed an appeal.
The coalition argues the appeals court should block the merger because ‘states have seen a wave of hospital consolidation, resulting in large healthcare systems with substantial market power and the ability to wield it to the detriment of insurers and patients,’ according to a news release from Mr. Bonta's office.”
In a related article on the same topic: Hospital M&A: 18 recent deals

About healthcare IT

Researchers uncover software flaws leaving medical devices vulnerable to hackers: “Researchers say they have found more than a dozen vulnerabilities in software used in medical devices and machinery used in other industries that, if exploited by a hacker, could cause critical equipment such as patient monitors to crash. 
The research, shared exclusively with CNN, points to the challenges that hospitals and other facilities have had in keeping sensitive software updated as the resource-absorbing coronavirus pandemic continues. It's also an example of how federal agencies are working more closely with researchers to investigate cybersecurity flaws that could affect patient safety.
Nearly 4,000 devices made by a range of vendors in the health care, government and retail sectors are running the vulnerable software, according to cybersecurity firms Forescout Technologies and Medigate, which discovered the issue.”

Today's News and Commentary

About Covid-19

Appeals court stays vaccine mandate on larger businesses“The 5th U.S. Circuit Court of Appeals granted an emergency stay of the requirement by the federal Occupational Safety and Health Administration that those workers be vaccinated by Jan. 4 or face mask requirements and weekly tests.
Louisiana Attorney General Jeff Landry said the action stops President Joe Biden ‘from moving forward with his unlawful overreach.’
‘The president will not impose medical procedures on the American people without the checks and balances afforded by the constitution,’ said a statement from Landry, a Republican. 
The U.S. Labor Department’s top legal adviser, Solicitor of Labor Seema Nanda, said the department is ‘confident in its legal authority to issue the emergency temporary standard on vaccination and testing.’”

SARS-CoV-2 vaccine protection and deaths among US veterans during 2021: Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge. From July to October 2021, VE-D for age 65 years was 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech; VE-D for age ≥65 years was 52.2% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer-BioNTech. Findings support continued efforts to increase vaccination, booster campaigns, and multiple, additional layers of protection against infection.”

NIH scientists identify mechanism that may influence infectivity of SARS-CoV-2 variants: “The outer surface of SARS-CoV-2 is decorated with spike proteins, which the virus uses to attach to and enter cells. Before this can happen, though, the spike protein must be activated by a series of cuts, or cleavages, by host proteins, starting with the furin enzyme. In the alpha and delta variants, mutations to the spike protein appear to enhance furin cleavage, which is thought to make the virus more effective at entering cells.”

Israeli plan for COVID vaccine tablet gets $4.3m from Bill Gates-backed fund: “MigVax is aiming not only to produce a tablet vaccine, but also to make it particularly sturdy against new variants as well as adaptable to future viruses. It expects to achieve these aims using its subunit vaccine, which contains purified pieces of the virus that were selected for their ability to stimulate immune cells.”

The United States reopens to vaccinated international travelers:  The previously reported travel rules have been officially implemented. Airlines are responsible for gathering and verifying information from their customers. Each state’s laws (especially masking) still apply. The article is a good reminder of the terms.

These two article are excellent explanations of the topics in their headlines: 
Pediatric COVID-19 Vaccines: What Parents, Practitioners, and Policy Makers Need to Know

Understanding Breakthrough Infections Following mRNA SARS-CoV-2 Vaccination

Regeneron COVID-19 antibody drug reduces infection risk 82% in clinical trial: Regeneron said Nov. 8 that its COVID-19 antibody cocktail reduced the risk of contracting COVID-19 by 81.6 percent for eight months after administration in a phase 3 clinical trial. 
During the eight-month follow-up period, Regeneron said there were no hospitalizations from COVID-19 infection among the people receiving the antibody cocktail, called REGEN-COV, and six in the placebo group.”

30 pharmacies ranked by customer satisfaction: FYI: Good Neighbor Pharmacy is the highest-ranked [brick and mortar and all-category] pharmacy in the U.S. in terms of customer satisfaction, according to consumer insight firm J.D. Power's annual pharmacy satisfaction survey.” Check the article or survey for the rest of the categories and rankings.

About hospitals and health systems

Michigan systems to disband 5,400-physician network: “Five Michigan health systems are ceasing operation of Affirmant Health Partners, their clinically integrated network, at the end of this year. 
The following five Michigan organizations make up Affirmant Health Partners: Saginaw-based Covenant HealthCare; Detroit-based Henry Ford Health System; St. Joseph-based Spectrum Health Lakeland; Lansing-based Sparrow Health System; and Kalamazoo-based Bronson Healthcare Group.
The decision by Affirmant Health Partners' board to shutter operation of the 5,400-physician network was attributed to several factors, including changes in strategy among the five participating systems and reductions in Medicare participation.”

About pharma

Moderna finally cracks into gene editing with Metagenomi pact thanks to 'irresistible' dataModerna “has signed a research partnership with CRISPR gene editing company Metagenomi…
[T]he partnership will involve in vivo treatment options for serious genetic diseases. Metagenomi will offer up access to its gene editing tools while Moderna will bring the expertise in mRNA and lipid nanoparticle delivery technologies.”

Pharmaceutical industry likely to shatter its lobbying record as it works to shape Democrats’ spending bill:  “The influence campaign at times worked through groups whose funding sources are hidden. At least 20 different advertisements were run on television and online across the country. The advertisements were augmented by a campaign by PhRMA, which spent nearly $23 million on lobbying through the first nine months of 2021, according to data compiled by OpenSecrets, which tracks corporate spending and political influence. That puts PhRMA on track this year to beat its own spending recording of $29.3 million in 2019.”

About healthcare IT

On-Demand Telehealth Is Booming Even as a Fierce Competitor Remains: the Doctor’s Office : The article is a good summary of opinions of those who use telehealth.For example: “72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.”
About 90% of those using telehealth found it to be friendly, easy and affordable.

 What Healthcare Consumers Want and Need from Life Sciences Manufacturers: While the title sounds like a product marketing piece, it is really about how members of different generations seek information about healthcare and how much they trust the sources.
While there are obviously differences, in the category: “Which channels are the most effective in reaching consumers seeking healthcare information?”, all groups rate the physician’s office as the number one source.

 

 

 

 

 

 

 

 

 

 

 

Today's News and Commentary

About Covid-19

Experimental Pfizer pill prevents Covid hospitalizations and deaths“The Pfizer medicine, known by the code name PF-07321332 or simply ’332, reduced hospitalization by 89% compared to placebo when given with the HIV drug ritonavir within three days of symptom onset. The medicine also reduced the chance that patients would die. There were 7 deaths out of 385 patients in the placebo group, and none in the 389-patient group that received the medicines. Pfizer plans to market ‘332 under the brand name Paxlovid.”

Pandemic marked by premature deaths, lost years of life“More than 28 million extra years of life were lost among 31 high- and upper-middle–income countries, and 33 nations saw declines in life expectancy, amid the COVID-19 pandemic in 2020, concludes a study yesterday in BMJ.”

Study into gene that affects Covid severity should be treated with caution“In the second wave of the pandemic those with Pakistani backgrounds were more than twice as likely to die from Covid-19 than those from white European backgrounds. For those of Bangladeshi heritage the risk was three- to four-fold…
Now, it seems, part of the explanation could be genetic. A gene has been found that alters the way that cells in the lining of the lungs respond to the Covid-19 infection…
The University of Oxford scientists behind the study estimate that the high-risk gene is carried by about 60% of those with south Asian heritage, compared with 15% of those with white European backgrounds and just 2% of those with black African or Caribbean heritage.”

Moderna cuts forecast for COVID-19 vaccine sales: “Moderna downgraded the 2021 sales expectations for its COVID-19 vaccine Spikevax to between $15 billion and $18 billion, from $20 billion projected in August, saying it will have fewer doses for delivery this year. The disclosure, made during its third-quarter earnings call on Thursday, sent shares tumbling as much as 17%….
Moderna explained that its output has been affected by ‘longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp-up of product release to market.’
By contrast, Pfizer earlier this week raised the sales projection for its BioNTech-partnered coronavirus vaccine Comirnaty for the third time this year, saying it now expects sales of $36 billion from the shot, reflecting the delivery of 2.3 billion doses.”

Antibody Titers Before and After a Third Dose of the SARS-CoV-2 BNT162b2 [Pfizer] Vaccine in Adults Aged ≥60 Years: “This study found that a third BNT162b2 dose in adults aged 60 years and older was associated with significantly increased IgG titers after 10 to 19 days, with no major adverse events.”

LumiraDx’s COVID-19 Antigen Test Expands Indication to Asymptomatic People“The FDA has granted an expanded Emergency Use Authorization for LumiraDx’s COVID-19 antigen test to include testing of asymptomatic people.
In asymptomatic individuals, the 12-minute test was 82.1 percent agreement on positive results and 100 percent agreement on negative results, when compared with results from a laboratory polymerase chain-reaction test, according to the UK-based company.”

More than 10K patients contracted COVID after visiting a hospital for other care“More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.”

U.S. cancels multimillion-dollar deal with coronavirus vaccine maker whose plant ruined Johnson & Johnson doses: “The federal government has canceled a deal worth $628 million with Emergent BioSolutions, the Maryland-based vaccine manufacturer that was a vanguard of the Trump administration’s program to rapidly produce vaccines to counter the coronavirus pandemic.

The company disclosed the development on Thursday in a conference call discussing its latest financial results. The cancellation comes after Emergent’s manufacturing facilities in Baltimore were found to have produced millions of contaminated vaccine doses this spring, prompting a months-long shutdown.”

DeSantis says OSHA rules on vaccines, masks are federal overreach. Florida’s suing“Gov. Ron DeSantis announced Thursday he would join a lawsuit with Georgia, Alabama and private plaintiffs seeking to nullify a rule by President Joe Biden’s administration mandating coronavirus vaccines or testing in large workplaces. At a news conference in Tallahassee, DeSantis said the rule was an example of federal overreach. The federal government does not have the power to hand down health mandates, DeSantis argued, nor does it have the power to enforce its rule with fines as high as $13,653 per violation. He also argued that a rule that has been coming for close to two months and which requires workers to be vaccinated by Jan. 4 can hardly be a response to an ‘emergency.’”

A doctor spread COVID misinformation and renewed her license with a mouse click: “For much of the pandemic, Dr. Lee Merritt has appeared on talk shows and in lecture halls to spread false information about COVID-19.
Among her claims: that the SARS-CoV2 virus is a genetically engineered bioweapon (the U.S. intelligence community says it's not). And that vaccination dramatically increases the risk of death from COVID (data show an enormous drop in risk for those who take the vaccine). The entire pandemic, she says in public lectures, is a vast global conspiracy to exert social control.
And yet, in October, she was able to renew her medical license in the state of Nebraska. Documents obtained through a public records request by NPR showed it took just a few clicks: 12 yes-or-no questions answered online allowed her to extend her license for another year. Critics say that Merritt's renewal is another example of how the nation's state medical boards are failing to protect the public from a small minority of doctors spreading COVID falsehoods.”
State medical boards said they would not allow renewals for such physicians, however, enforcement is obviously lax. Perhaps something akin to a “no fly list” is needed to flag such people.

About health insurance

 Healthcare Affordability State Policy Scorecard: From Altarum. Massachusetts and R.I. are at the top, while Georgia and Texas are at the bottom. 

Arkansas Man Charged in $100 Million COVID-19 Health Care Fraud Scheme: According to court documents, Billy Joe Taylor, 42, of Lavaca, engaged in a scheme between February 2017 and May 2021 in connection with diagnostic laboratory testing, including urine drug testing and tests for respiratory illnesses during the COVID-19 pandemic, that were medically unnecessary, not ordered by medical providers, and/or not provided as represented. According to the indictment, Taylor controlled and directed multiple diagnostic laboratories, and used those labs to submit more than $100 million in false and fraudulent claims to Medicare. The indictment alleges that Taylor obtained medical information and private personal information for Medicare beneficiaries, and then misused that confidential information to repeatedly submit claims to Medicare for diagnostic tests that were not ordered by medical providers and were not actually performed by the laboratories.”

Health Insurance Trends-November 2021A survey from eHealth.
Some highlights:
“83% of Medicare beneficiary survey respondents want the federal government to take direct action to lower the cost of prescription drugs by negotiating with pharmaceutical companies. This is true across
political lines, including strong majorities of Democrats (93%), Republicans (73%), and Independents (84%).

92% of Medicare beneficiaries would like to see dental, vision, and • hearing benefits added to traditional Medicare coverage, but only 50% feel the same if it would add to their costs.

When asked if they felt the health insurance options available to them addressed the specific medical needs of their racial or ethnic community, Hispanic respondents were least likely to say yes (41%), followed by Asian (45%), and Black (46%) respondents. By contrast, 58% of white respondents answered yes.

With an estimated 10,000 new Medicare beneficiaries every day, the number one place they go to learn about their Medicare coverage options is online.

69% of them want the freedom to look beyond government-run online marketplaces to shop for, compare, and enroll in coverage. 

When it comes to health care innovation and technology, more than half (52%) of general population respondents say private enterprise does a better job than government. Only 18% say the government does a better job.”

About healthcare IT

 How Likely Your State’s Businesses are to Recover from Cyberattacks: From a Verizon study. See the article for methodology and rankings. The best is Vermont and the worst is Delaware.

Alphabet launches AI drug discovery venture built on DeepMind's protein-folding expertise: “Google’s parent company Alphabet is diving into the drug discovery game with an artificial intelligence company built on the protein-folding simulation successes achieved at DeepMind.
The new Isomorphic Laboratories aims to deliver an ‘AI-first approach’ for tackling biopharma research, with the goal of serving as a commercial partner to drugmakers and figuring out how medicines will react within the body.”

Federal agencies rush to patch hundreds of cyber vulnerabilities within 6 months: “As hackers launched increasingly damaging threats against critical infrastructures such as hospitals, the Cybersecurity and Infrastructure Security Agency is requiring all federal agencies to patch cyber vulnerabilities within six months, according to a Nov. 3 directive
Under the binding operational directive, federal agencies must establish policies to remediate approximately 300 known exploited vulnerabilities known to CISA within 60 days. Federal agencies have two weeks to patch vulnerabilities discovered in 2021 and six months to patch vulnerabilities discovered prior to 2021.”

About hospitals and health systems

2021 State of Healthcare Performance Improvement: COVID Creates a Challenging EnvironmentA survey by KaufmanHall. 
Highlights: 
“100% of survey respondents face issues with clinical staff, including burnout, difficulty filling vacancies, wage inflation, and high turnover rates. 
99% have experienced challenges in supply procurement, including shortages of key items and significant price increases. 
92% are having difficulties attracting and retaining support staff, and almost 90% have increased base salaries . 
75% have experienced adverse revenue cycle impacts during the pandemic, including a higher percentage of Medicaid patients and increased rates of denial . 
54% identify a “pain point” at an investment (or subsidy) per physician of $250,000 or less. The average investment per physician at the end of Q2 2021 was $232,583 . 
23% say that the ratio of administrative staff working remotely is likely to return to pre-pandemic levels. 66% said the ratio will remain at levels reached during the pandemic, and 11% said the percentage of staff working remotely will continue to increase. 
22% have seen pediatric services return to pre-pandemic levels, while 16% say pediatric volumes remain below 75% of pre-pandemic levels. Cardiology and cardiovascular services have seen the most significant rebound, but even here, just 44% of respondents have seen a return to pre-pandemic levels.”

About diagnostics

Test determines antibiotic resistance in less than 90 minutes: “A technique that measures the metabolic activity of bacteria with an electric probe can identify antibiotic resistance in less than 90 minutes, a dramatic improvement from the one to two days required by current techniques.
This discovery means that doctors could quickly know which antibiotics will or won't work for a patient's life-threatening infection, a quandary that doctors face on a daily basis in hospitals around the world. A Washington State University research team reports on their work in the journal, Biosensors and Bioelectronics.”

 

 

Today's News and Commentary

About Covid-19

Cue the lawsuits: Biden's vaccine mandates are here: The official recommendations are now out. The article provides a good summary of what will be officially published in The Federal Register tomorrow.
Among the highlights:
The Biden administration is implementing a true vaccine mandate for 17 million health-care workers. The emergency regulation requires vaccines for staff of the roughly 76,000 health facilities participating in Medicare and Medicaid, such as nursing homes, hospitals and home health agencies. Unlike other mandates, staff won’t be allowed to test regularly in lieu of getting the shot, though it does include religious and medical exemptions…”
CMS is making the immunization a Condition of Participation for Medicare, meaning that non-compliant hospitals can lose their Medicare provider status.
Companies with 100 or more employees must now mandate coronavirus vaccine shots or weekly testing. 
The Occupational Safety and Health Administration is relying on little-used emergency powers to issue the new rules expected to cover 84 million workers. 
Under the regulations:

  • The unvaccinated will be required to wear masks.

  • Employers must provide paid time off for their staff to get a shot.

  • Companies can make their employees foot the bill for their own tests.”

EMA Scraps Review of Eli Lilly’s COVID-19 Antibody Therapy: “The European Medicines Agency (EMA) has stopped its rolling review of Eli Lilly’s COVID-19 antibody cocktail after the drugmaker withdrew its request because of the lack of demand among EU member states.”
Contrast that action with the US where the federal government announced it will purchase “a further 614,000 doses of Eli Lilly’s COVID-19 therapy, bamlanivimab and etesevimab, for $1.29 billion.”

Britain authorizes Merck’s molnupiravir, the world’s first approval of oral covid-19 treatment pill: “Regulators in Britain granted approval to the experimental drug molnupiravir from U.S. pharmaceutical giant Merck on Thursday, marking the first authorization from a public health body for an oral antiviral treatment for covid-19 in adults.”

Visualizing in deceased COVID-19 patients how SARS-CoV-2 attacks the respiratory and olfactory mucosae but spares the olfactory bulb: Covid-19 appears to inflict the peripheral mucosa causing derangements in smell. “Thus, SARS-CoV-2 does not appear to be a neurotropic virus.” What the finding means is that, since permanent central nerve damage is not occurring, prospects for recovery of function are good.

About the public’s health

Life expectancy fell sharply in the U.S. last year among high-income countries: “The United States had the second-steepest decline in life expectancy among high-income countries last year during the pandemic, according to a study of death data spanning several continents
The only country studied that saw a starker overall trend was Russia.
U.S. men saw life expectancy fall by nearly 2.3 years, from about 76.7 to 74.4. Women lost more than 1.6 years of life expectancy, from about 81.8 to 80.2…
One surprise: The drop in life expectancy in the U.S. was driven by the deaths of young people…”

Panel: All US adults under 60 should get hepatitis B shots: “The Advisory Committee on Immunization Practices voted unanimously to approve the recommendation Wednesday. The CDC’s director, Dr. Rochelle Walensky, must sign off on it before it becomes public policy, but it’s not clear when she will decide.”

The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study: “We observed a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunisation programme in England, especially in individuals who were offered the vaccine at age 12–13 years. The HPV immunisation programme has successfully almost eliminated cervical cancer in women born since Sept 1, 1995.”
For those vaccinated at age 12-13 the risk reduction was 97%.

About pharma

Novartis to sell Roche stake for $20.7 billion: “Novartis said Thursday that it agreed to sell its stake in Roche for $20.7 billion, with the proceeds to be used ‘in line with capital allocation priorities to enhance strong returns to shareholders.’ Novartis built up the stake between 2001 and 2003, and currently holds 53.3 million bearer shares of Roche's stock, representing approximately 33% of aggregate outstanding bearer shares.
’After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetise our investment,’ remarked Novartis CEO Vas Narasimhan.”

About health insurance

45% of Insured Americans Considering Health Insurance Changes During Open Enrollment: “Most commonly, those looking to change their health insurance are doing so in response to the COVID-19 pandemic (35%) or their transforming health needs (33%).
Additionally, 27% of consumers are considering changing their health insurance coverage for cost-related reasons. For 18% of this group, the driving force is that out-of-pocket costs were too high last year. Another 9% of people feel they pay for more insurance than what they use, so they're seeking to cut back on expenses.”
Next is seeing how many actually switched, as contemplation of changing insurance is not highly correlated with actual changing.

Centene selling off majority stake in U.S. Medical Management: “Centene will sell off its majority stake in home health company U.S. Medical Management, the insurer announced Wednesday.
Centene will maintain a minority stake in USMM, according to the announcement, and will sell the rest of its stake to Rubicon Partners; Valtruis, a WCAS company; Oak HC/FT; and HLM Venture Partners. 
USMM operates a family of companies that provide home health services, and in 2015 launched an accountable care organization. It owns assets that assist with home-based primary care and house call programs, according to the announcement.”
A noteworthy development as other insurers are increasingly vertically integrating. As an example:

CVS Looks to Add Doctors to Its Payroll: “On Wednesday, CVS Chief Executive Karen Lynch said the company is working with “speed and urgency” to create physician-staffed primary-care practices, which she said will be a priority for CVS as it considers potential acquisitions in the coming year.
’Primary care isn’t a big medical cost but it wields a lot of influence,’ Ms. Lynch said in an interview, referring to the role physicians can play in lowering insurers’ costs.”

Cigna beats the Street with $1.6B in Q3 profit: “Cigna wrapped up third-quarter earnings for major national payers Thursday morning, where it reported $1.6 billion in profit for the quarter.
The results surpassed Wall Street expectations, according to Zacks Investment Research. Cigna also brought in $44.3 billion in revenue in the third quarter, according to the earnings report, which also beat analysts' projections.”

Humana cuts 2021 outlook after higher COVID-19 expenses but still plans robust Medicare Advantage growth for 2022: “Humana expects its individual Medicare Advantage membership to grow by 8% in 2022 as part of a more conservative financial outlook. 
The insurer gave hints to its outlook for next year as part of its earnings report released Wednesday that saw Humana post a $1.5 billion profit in the third quarter but cut its financial outlook for 2021 due in part to higher-than-expected COVID-19 costs.
The insurer’s third-quarter earnings report, though, released Wednesday, pointed to strong growth in its Medicare Advantage offerings and lower-than-expected healthcare use among MA beneficiaries.”

CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1753FC): The announcement has specifics about price transparency requirements (previously reported), OPPS and ASC payment rates, changes to the inpatient-only list, and much more.

Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule: Many more details about changes, including telehealth payment and the previously reported new conversion factor:
”With the budget neutrality adjustment to account for changes in RVUs (required by law), and expiration of the 3.75 percent temporary CY 2021 payment increase provided by the Consolidated Appropriations Act, 2021 (CAA), the CY 2022 PFS conversion factor is $33.59, a decrease of $1.30 from the CY 2021 PFS conversion factor of $34.89. The PFS conversion factor reflects the statutory update of zero percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from our finalized policies.”

Today's News and Commentary

About health insurance

CMS Releases Final Rule for CY 2022 Medicare Physician Fee Schedule: “CMS has finalized the calendar year (CY) 2022 Medicare Physician Fee Schedule to promote greater telehealth utilization, boost reimbursement rates for vaccine administration, and improve health equity, among other initiatives, the federal agency said.
The final rule will implement ‘a series of standard technical proposals’ as part of CY 2022 rate-setting, CMS said. The conversion factor for next year will be $33.59, a decrease of $1.30 versus the CY 2021 conversion factor. Next year’s rate accounts for statutory changes to relative value units (RVUs) and the expiration of the 3.75 percent temporary CY 2021 payment increase Congress approved through pandemic-related legislation.
The CY 2022 conversion factor also reflects a statutory update of 0 percent and an adjustment necessary to account for changes in RVUs and expenses that would result from our finalized policies, according to the final rule.”

Hospital Price Transparency Penalties to Increase Under OPPS Rule: “Starting January 1, CMS will increase penalties for noncompliance with hospital price transparency requirements under the newly released Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule.
The Final Rule sets the minimum civil monetary penalty of $300 per day for smaller hospitals with a bed count of 30 or fewer, and a penalty of $10 per bed per day for hospitals with a bed count greater than 30. However, the penalty is not to exceed a maximum daily dollar amount of $5,500.
Under the new approach, hospitals could be responsible for paying a maximum of over $2 million if they fail to comply with the requirements.”

Feds Nail Podiatrist For Alleged $11M Foot Bath Fraud Scheme : “A Mississippi podiatrist made Medicare and insurance companies foot the bill for more than $11. 3 million in prescriptions for pricey and unnecessary bath treatments, a federal indictment unsealed Tuesday claims. Foot doctor Carey ‘Craig’ Williams, 63, also allegedly took kickbacks for harvesting patients' toenails and wound swabs so a medical lab could perform, and seek reimbursement for, unnecessary bacterial and fungal screenings, prosecutors say. According to the indictment, Williams participated in the scheme for five years alongside two unidentified podiatrists and a Mississippi pharmaceutical sales representative…”
Can you spot the three puns in the story?

Bartko, Zankel, Bunzel & Miller Files Antitrust Lawsuit Against MultiPlan Co. & Major Health Insurers: “Bartko, Zankel, Bunzel & Miller filed a lawsuit on behalf of Verity Health Systems Liquidating Trust (‘Verity’) against MultiPlan and major health insurers for antitrust practices that violate California's Cartwright Act and Unfair Competition Law. MultiPlan admits its customers, healthcare insurance companies, paid Verity and other U.S. health care providers billions of dollars less annually than they otherwise would have for at least 10 years.
According to court documents, MultiPlan acted as an unlawful corporate hub as part of a "hub, spoke, and rim" agreement, together with most major insurance companies, to fix and artificially reduce the amounts of out-of-network reimbursement paid to hospitals. By setting lower, fixed prices for payments for healthcare provided by hospitals, MultiPlan worked with major insurance companies to exert their market dominance and cut reimbursements to hospitals by about $10 billion per year from 2012 through 2020.”

About Covid-19

Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19: “This comparative effectiveness research study found that, through large-scale longitudinal retrospective curation of electronic health records from the multistate Mayo Clinic Health System, the Ad26.COV2.S vaccine [J&J] had an effectiveness of 74%.”

About pharma

Schumer announces deal to lower prescription drug prices: “The deal would allow negotiation after nine years for many drugs, known as small molecule drugs, and after 12 years for more complex drugs known as biologics, according to a summary obtained by The Hill.
If drug companies refuse to negotiate, they would face an excise tax as a punishment, a provision that has been controversial with some moderates.
Medicare could negotiate up to 10 drugs starting in 2025, and up to 20 drugs in 2028 and beyond, according to the summary.
Insulin copays would be capped at $35 per month.”

CVS Health beats on earnings, gets lift from Covid vaccines and prescription volumes: “The drugstore chain raised its forecast for the year, saying it expects adjusted earnings per share of $7.90 to $8.00, from $7.70 to $7.80.
The company administered 8.5 million Covid tests and 11.6 million shots during the three-month period.”

Company Q3 reports:
Novo Nordisk's sales, profit top expectations in Q3
Amgen boosts profit outlook despite Q3 sales hit by pricing pressure
Bausch Health's Q3 sales slip as earnings more than double

About the public’s health

'Impossible to enforce': Big Tobacco exploiting loopholes in European menthol ban: “Tobacco companies are finding loopholes in the Europe-wide menthol cigarette ban in order to keep selling products that can get new, younger smokers hooked on tobacco.
Japan Tobacco International (JTI) – which owns Sterling, Benson & Hedges and Sovereign – has been able to work around a ban imposed in 2020 that was intended to prevent young people from taking up smoking cigarettes. Competitors have called for governments to investigate the company’s new ‘menthol reimagined’ products.”

About healthcare professionals

Trends in Outpatient Care for Medicare Beneficiaries and Implications for Primary Care, 2000 to 2019: “Outpatient care for Medicare beneficiaries has shifted toward more specialist care received from more physicians without increased primary care contact. This represents a substantial expansion of the coordination burden faced by PCPs.”

Today's News and Commentary

About Covid-19

CDC signs off on children’s coronavirus vaccine, allowing providers to begin immunizing kids ages 5 to 11 immediately

ADDENDUM: Yesterday, news media reported that global Covid-19 deaths surpassed 5 million. In reviewing the list of countries, China’s absence is notable.

Novavax Files for COVID-19 Vaccine Authorization in Canada, EU: “Novavax has completed regulatory submissions with Health Canada and the European Medicines Agency for authorization of its COVID-19 vaccine, NVX-CoV2373, and said it will seek an FDA Emergency Use Authorization for the shot by year’s end.”

Vaccination and Safety Protocols: From the federal government: Many new answers to questions businesses may have about vaccination status of employees.

About healthcare IT

Northwell Health and Aegis Ventures to form first-of-its-kind artificial intelligence venture to drive better, more equitable, and lower-cost healthcare: “-Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, a New York-based startup studio, today announced they are forming a joint venture (JV) that will ideate, launch, and scale AI-driven companies to address healthcare’s most challenging quality, equity, and cost problems. The JV will assemble leading medical, technology, and business resources to create a first-of-its-kind company creation platform for healthcare innovation. Aegis Ventures intends to invest at least $100 million of seed-stage funds through the platform to catalyze a significant multiple of that amount from the venture capital and investment community.
The JV will work with stakeholders across the Northwell system to create new patient care solutions through collaboration with frontline clinicians, working side-by-side from ideation to implementation, to develop innovations that use AI to predict, diagnose, and manage health conditions. The parties have already started work on solutions related to improving maternal health outcomes and chronic disease prediction.”

About pharma

Opioid Makers Win Major Victory in California Trial: “Four manufacturers of prescription opioids won the pharmaceutical industry’s first major legal victory in the opioid crisis, turning aside claims by local California governments that they contributed substantially to the epidemic…
’There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need,’ wrote Judge Peter Wilson of Orange County State Superior Court, who presided over a four-month bench trial.
The manufacturers include Johnson & Johnson, which has a nationwide opioids settlement offer pending; Teva, a maker of generic opioids based in Israel; Allergan, a subsidiary of AbbVie; and Endo Pharmaceuticals.”

Federal judge rules HHS' efforts to punish pharma over 340B restrictions 'arbitrary and capricious': “The pharmaceutical industry scored a muted win in its long-running feud with the Department of Health and Human Services (HHS) over 340B program discounts Friday when a federal court judge granted Eli Lilly’s bid to vacate two administrative actions aimed at drugmakers.
U.S. District Court Judge Sarah Evans Barker ruled that a December advisory opinion from HHS’ Office of the General Counsel and a May enforcement letter from the Health Resources and Services Administration (HRSA) were ‘arbitrary and capricious’ and in violation of the Administrative Procedures Act.
But while Barker ordered the two actions to be set aside and vacated, she also specified that HHS did not exceed its statutory authority or act unconstitutionally in regard to the May enforcement letter.”

About hospitals and health systems

National Hospital Flash Report: October 2021: Among the highlights: “High numbers of high-acuity patients coupled with escalating expenses continued to stress the nation’s hospitals and health systems in September. Actual hospital operating margins remained close to the prior month’s levels. The median Kaufman Hall Operating Margin Index was 3.2% in September, not including federal CARES Act funding. With the aid, it was 4.1%…
Expenses continued to climb. Total Expense per Adjusted Discharge was up 2.6% YTD and 12.9% YOY. Labor expenses rose across all measures even as the number of hospital workers per patient bed declined, reflecting higher pay as hospitals compete for healthcare professionals amid nationwide labor shortages. Non-labor expenses also rose due to significant increases in drug and supply expenses driven in part by worldwide supply chain issues.”

About the public’s health

Every Country Affected: The Tobacco Industry Used the COVID-19 Pandemic to Build Influence With Governments in 80 Countries: “A new report from tobacco industry watchdog STOP reveals that the tobacco industry embraced the COVID-19 pandemic as an opportunity to gain influence, meddle in life-saving health policies and secure preferential treatment. Reports from civil society organizations in 80 countries, analyzed in the Global Tobacco Industry Interference Index 2021, show that no country was immune to the industry’s efforts to use lobbying and donations, often connected to pandemic response, to its advantage…”
Among the specific findings: “Although tobacco is an addictive and harmful product, at least ten governments deemed the tobacco industry and cigarettes to be ‘essential’ during the pandemic or a vital part of their economic recovery efforts, including Bangladesh, Brazil, Jordan, Malaysia, New Zealand, Peru and Sudan.
Countries that have not signed the global treaty, the World Health Organization Framework Convention on Tobacco Control (FCTC), face high levels of industry meddling. These include Argentina, the Dominican Republic, Indonesia, Switzerland and the U.S.A.” [Emphases in the original]

About healthcare devices

DRH Proposed Guidances for Fiscal Year 2022 (FY2022): This past week, the FDA’s Center for Devices and Radiological Health (CDRH) published proposed and finalized guidelines for which it is interested in receiving external feedback. Among the targeted areas is Clinical Decision Support Software.

A smart knee implant promises to ‘help write the future of orthopedic technology.’ Surgeons aren’t so sure: Is newer, smarter technology better technology?
“Last month, surgeons implanted the first of a new, souped-up knee implant, developed by Zimmer Biomet as a way to passively collect data about recovery after one of medicine’s priciest and most common procedures…
But the surgeons who will need to embrace the implant caution that while the device has potential, insights are likely far off — if the data turns out to be useful at all.
’Technology has to be proven that it’s going to improve outcomes in order to be used,” Calin Moucha, the chief joint replacement surgeon at the Mount Sinai health system in New York said. “So, you know, even though this sounds like a cool idea … this isn’t going to improve our outcomes.’”

The US Copyright Office just struck a blow supporting the right to repair: “The US Copyright Office is expanding a legal shield for fixing digital devices, including cars and medical devices. This morning, the office submitted new exemptions to Section 1201 of the Digital Millennium Copyright Act, which bars breaking software copy protection. The resulting rules include a revamped section on device repair, reflecting renewed government pressure around “right to repair” issues.
The Register of Copyrights recommends Section 1201 “anti-circumvention” exemptions every three years, a process that has offered legal protections for everything from unlocking cellphones to ripping DVD clips for classroom use. In addition to renewing these and several other exemptions, this latest rulemaking adopts repair-related proposals from the Electronic Frontier Foundation, iFixit, and other organizations.”

EU orders Illumina to keep Grail a separate company: “Illumina announced on Aug 18 that it had completed its acquisition of Grail even though the Commission, which oversees EU competition policy, had not completed its investigation into the merger. That review is currently set to run until Feb. 4….
The measures provide that Grail be kept separate from Illumina and run by independent managers, that the two companies do not share confidential information, the interactions be kept at arms length and that Grail work on alternative options in case the Commission rejected the merger.”

About health insurance

Biden administration doubling down on ACA open enrollment outreach campaigns with health equity in mind: “The Biden administration has extended the Affordable Care Act (ACA) open enrollment period by one month and invested in a more robust outreach campaign as part of its efforts to bolster the legislation.
The Centers for Medicare & Medicaid Services (CMS) kicked off Monday the start of the HealthCare.gov open enrollment period, which has been extended to Jan. 15, 2022…
’Four out of five consumers will be able to find plans for $10 per month or less with this newly expanded financial assistance,’ Brooks-LaSure said during a call with reporters Monday.”
A significant problem that remains is the out-of-pocket expenses.

1 in 3 insured workers would consider leaving jobs if health insurance weren’t a factor: “Key findings

  • One in three workers (either full-time or part-time) with health insurance (33%) said they would be very or somewhat likely to leave their jobs in the near future if health insurance wasn’t a factor.

  • 26% of Americans with health insurance would be very or somewhat likely to start their own business if health insurance wasn’t a factor.

  • People who get most of their health insurance information from social media are much more likely to have ever avoided testing (39% of those getting most of their health insurance information from social media vs. 14% of those relying most on other sources) and care (22% vs. 8%) for COVID-19.

  • A combined 70% of Americans either don’t know whether you can get financial assistance to get a plan from the federal health insurance marketplace (61%) or believe you cannot (9%).”

Geisinger to pay $18.5M to settle allegations of fraudulent billing: “Danville, Pa.-based Geisinger Community Health Services will pay $18.5 million to resolve allegations that it improperly billed Medicare for hospice and home health services, the Justice Department said Nov. 1.
The settlement resolves self-disclosed violations of Medicare billing rules and includes filings submitted by Geisinger between January 2012 and December 2017.
According to the voluntary disclosure, the billing errors were related to Medicare rules involving physician certifications of terminal illness, patient elections of hospice care and physician face-to-face encounters with home health patients.”

Medicare drops end-stage renal disease payment rule that aims to close health equity gaps: “The Centers for Medicare & Medicaid Services (CMS) finalized a rule that updates payment rates for the End-Stage Renal Disease Prospective Payment System (ESRD PPS) and makes changes to the quality incentive program and the ESRD Treatment Choices (ETC) model. The goal of the changes is to encourage dialysis providers to decrease disparities in home dialysis and transplant rates, part of a larger effort by the Biden administration.
It marks the first CMS Innovation Center model to directly address health equity.” [Emphasis added]

Texas Medical Association files suit against surprise billing rule's 'unlawful' arbitration process: “The Texas Medical Association (TMA) has brought a lawsuit against the Biden administration arguing that the interim final rule on surprise billing goes against the intent of Congress and will ultimately harm patients.
Filed Thursday in the U.S. District Court for the Eastern District of Texas, the case (PDF) is an escalation of the broad pushback the Department of Health and Human Services (HHS) received from providers after releasing the interim final rule in late September.”

Teladoc ramping up focus on virtual primary care with plans to take on financial risk: “During the company's third-quarter earnings call last week, Teladoc CEO Jason Gorevic said the company will take on degrees of risk, from clinical measures of care to risk corridors to, ultimately, full capitation.”