Today's News and Commentary

National Health Care Spending In 2020: Growth Driven By Federal Spending In Response To The COVID-19 Pandemic: This annual article in Health Affairs (subscription only) is well-worth reading. Below is the abstract:
”US health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. At the same time, gross domestic product declined 2.2 percent, and the share of the economy devoted to health care spending spiked, reaching 19.7 percent. In 2020 the number of uninsured people fell, while at the same time there were significant shifts in types of coverage.”

About Covid-19

15 sobering stats that tell the tale of the coronavirus in the U.S.: An excellent summary of where we are now with respect to the Covid-19 pandemic. For example:
“1 in 420: The number of Americans who have died of the coronavirus.”
1 in 100 people over age 65 have dies from the virus

4th COVID shots likely soon for some immunocompromised Israelis, says top doc: “Some immunocompromised people in Israel are likely to be offered a fourth COVID-19 vaccine shot within weeks, according to a member of the government’s pandemic advisory panel, The Times of Israel reported.
Galia Rahav, head of Sheba Medical Center’s Infectious Disease Unit, on Tuesday said that while fourth shots for the general population have been ruled out for now, her ongoing research underscores their importance for some.”

CDC advisers to weigh limits on Johnson & Johnson vaccine because of continued rare blood clot issues: “Vaccine advisers to the Centers for Disease Control and Prevention are meeting Thursday to weigh possible limits on the use of the Johnson & Johnson vaccine because of continued blood clot issues, mostly in young and middle-aged women, according to clinicians familiar with the agenda.”

Alera COVID-19 Employer Pulse Survey, Part 3: “Since the last COVID-19 Employer Pulse survey was released in June 2020, even more companies have implemented formal infectious disease response plans, especially those with over 1,000 employees. Overall, 67% now have a plan in place, and another 18% are putting a plan in place now or are considering developing a plan, compared to 43% and 46% respectively. There are only a few companies that continue to not consider putting a plan in place.”

Assessing the impact of the COVID-19 pandemic on clinician ambulatory electronic health record use: “Clinician time spent in the EHR per day dropped at the onset of the pandemic but had recovered to higher than prepandemic levels by July 2020. Time spent actively working in the EHR after-hours showed similar trends. These differences persisted in multivariable models. In-Basket messages received increased compared with prepandemic levels, with the largest increase coming from messages from patients, which increased to 157% of the prepandemic average. Each additional patient message was associated with a 2.32-min increase in EHR time per day (P < .001).”

COVID-19 can be a disability, says EEOC: “The Equal Employment Opportunity Commission released updated guidance Dec. 14 saying that a person diagnosed with COVID-19 can be considered to have a disability under certain circumstances. 
According to the new guidance, a person diagnosed with COVID-19 who has mild symptoms that resolve in a few weeks without issue will not be considered to have a disability under the Americans with Disabilities Act. A person can be considered to have a disability when their COVID-19 symptoms cause mental or physical impairment that ‘substantially limits one or more major life activities,’ the EEOC said. 
The EEOC said that whether the Americans with Disabilities Act applies to individual workers will be determined on a case-by-case basis ‘that applies existing legal standards to the facts of a particular individual's circumstances.’”

4 most common symptoms of omicron variant: “The four most common symptoms of the omicron variant are cough, fatigue, congestion and runny nose, according to a CDC analysis of the first 43 cases investigated in the U.S. 
People with COVID-19 can report a wide range of symptoms, with cough and loss of smell emerging as two frequent indicators of the virus.”

Omicron spreading rapidly in U.S. and could bring punishing wave as soon as January, CDC warns: “Top federal health officials warned in a briefing Tuesday morning that the omicron variant is rapidly spreading in the United States and could peak in a massive wave of infections as soon as January, according to new modeling analyzed by the Centers for Disease Control and Prevention.
The prevalence of omicron jumped sevenfold in a single week, according to the CDC, and at such a pace, the highly mutated variant of the coronavirus could ratchet up pressure on a health system already strained in many places as the delta variant continues its own surge.”

HHS releases $9B in provider relief payments: “HHS is distributing $9 billion in payments to healthcare providers affected by the COVID-19 pandemic. 
The funds will be split among more than 69,000 healthcare providers. HHS said the average payment for small providers is $58,000 and the average payment to large providers is $1.7 million…”

Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection: Bottom line- incidence of these cardiac problems is higher with Covid-19 infection than after getting vaccinated.
”Our findings are relevant to the public, clinicians and policy makers. First, there was an increase in the risk of myocarditis within a week of receiving the first dose of both adenovirus and mRNA vaccines, and a higher increased risk after the second dose of both mRNA vaccines. In contrast, we found no evidence of an increase in the risk of pericarditis or cardiac arrhythmias following vaccination, except in the 1–28 days following a second dose of the mRNA-1273 vaccine. Second, in the same population, there was a greater risk of myocarditis, pericarditis and cardiac arrhythmia following SARS-CoV-2 infection. Third, the increased risk of myocarditis after vaccination was higher in persons aged under 40 years. We estimated extra myocarditis events to be between 1 and 10 per million persons in the month following vaccination, which was substantially lower than the 40 extra events per million persons observed following SARS-CoV-2 infection.”

About health insurance

Goldman Sachs Projects Rosy 2022 For UnitedHealth Group, Anthem, CVS: “Goldman initiated coverage of 10 insurers, half of which received ‘buy’ ratings in the newest report: UnitedHealth Group, Anthem, CVS Health, Molina Healthcare and Alignment Healthcare. Another four were rated ‘neutral:’ Humana, Cigna, Bright Health Group. Just one, Oscar Health, got a ‘sell’ rating. 
Goldman analysts Nathan Rich and Lindsay Golub wrote that they project 13% earnings per share growth for large-cap managed care organizations over the course of 2022 and 2023, more than double their expected earnings growth across the S&P 500 of 6%.”

Dual Eligible Beneficiaries Prefer Medicare Advantage Over FFS: “Dual eligible beneficiaries were more likely to choose a Medicare Advantage plan over a fee-for-service Medicare plan, a study commissioned by Better Medicare Alliance (BMA) found….
Researchers found that 44 percent of dual eligible beneficiaries were enrolled in Medicare Advantage compared to 35 percent who were enrolled in fee-for-service Medicare. Additionally, 23 percent of all Medicare Advantage members were dual eligibles whereas 17 percent of fee-for-service Medicare beneficiaries were dual eligibles.
Dual eligible beneficiaries who were enrolled in Medicare Advantage were more likely to have a usual source of care compared to beneficiaries enrolled in a fee-for-service Medicare plan, the report found. Medicare Advantage dual eligibles received preventive care services more often than fee-for-service dual eligibles as well.”

Deadline time for HealthCare.gov coverage that starts Jan. 1: “Consumers seeking government-subsidized health insurance for next year have through Wednesday to sign up if they want their new plan to start Jan. 1.
Independent experts say HealthCare.gov’s sign-up season doesn’t seem to be drawing as many new customers this year — 8% to 9% fewer than last year — but it’s too early to draw final conclusions because deadlines drive much of the enrollment.
Open enrollment for the Affordable Care Act is different this time because it’s an early test of President Joe Biden’s idea that the U.S. can get close to coverage for all by building on existing programs.
Wednesday is the first of two deadlines for HealthCare.gov coverage, with increased financial assistance available through Biden’s coronavirus relief legislation. The last chance will come Jan. 15, for coverage that takes effect Feb. 1.”

About the public’s health

Screening for Prediabetes and Type 2 Diabetes in Children and Adolescents: For asymptomatic children and adolescents younger than age 18 years, the “USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in children and adolescents.”
The comment period is still open.

Today's News and Commentary

About healthcare policy

Biden releases 2,700-item to-do list: 5 healthcare updates: “President Joe Biden released a nearly 2,700-item regulatory to-do list Dec. 10 that targets mental healthcare, the 340B drug discount program and other healthcare issues through his administration's rulemaking authority…” Read the article for a summary of the 5 healthcare areas.

About health insurance

Employers' health insurance costs surge in 2021 as elective procedures resume - survey: “The survey by benefits company Mercer of firms that employ about 118 million people showed the average cost of employer-sponsored health insurance per employee jumped 6.3% this year to $14,542 - the largest rise since 2010.
The increase was just 3.4% in 2020 when the pandemic had strained hospital capacity and forced people to put off elective procedures.
‘I think that’s (catch-up care) certainly part of the cost driver,’ Kate Brown, Mercer’s Center for Health Innovation Leader, told Reuters.
Brown said several other factors, including claims related to the treatment of long-term effects of COVID-19 and specialty drug pricing, could also be driving the cost rise and may continue into 2022.”

Medicare urged to flex its power and slash back premium hike: Senate Finance Chairman Ron Wyden, D-Ore., “says the Biden administration should use its legal authority to cut back a hefty premium increase soon hitting millions of enrollees, as a growing number of Democratic lawmakers call for action amid worries over rising inflation.
Last month, Medicare announced one of the largest increases ever in its ‘Part B’ monthly premium for outpatient care, nearly $22, from $148.50 currently to $170.10 starting in January.
The agency attributed roughly half the hike, about $11 a month, to the need for a contingency fund to cover Aduhelm, a new $56,000 Alzheimer’s drug from Biogen whose benefits have been widely questioned. For most Medicare enrollees, the premium is deducted from their Social Security checks. Without further action, it would swallow up a significant chunk of seniors’ 5.9% cost of living increase.”

Four People Indicted in International Telemedicine Health Care Fraud Kickback Scheme: “Beginning in May 2014, the defendants and their conspirators began to use the telemedicine company to generate a high volume of prescriptions for compounded medications and, later, durable medical equipment (DME), without regard to medical necessity and through the payment of kickbacks. The defendants agreed and arranged for health care providers associated with the telemedicine company to write prescriptions for compounded medications and DME without the establishment of any provider-patient relationship, in exchange for kickbacks, and in violation of certain state telemedicine laws. Woroboff, Willard, and Mills agreed to pay [Dr. Le] Thu approximately $35 per prescription. Thu wrote prescriptions without speaking to patients in exchange for those payments.”

About Covid-19

Pfizer’s anti-covid pill prevents severe illness and should work against omicron variant, company says: “Reinforcing an earlier analysis from November, Pfizer’s drug cut hospitalizations and deaths by nearly 90 percent when taken within three or five days of the onset of symptoms, the company announced. Preliminary laboratory studies suggest the easy-to-take drug will hold up against the omicron variant.”

Merck’s Covid Pill Might Pose Risks for Pregnant Women: “Scientists are especially worried about pregnant women, they said, because the drug could affect a fetus’s dividing cells, theoretically causing birth defects. Members of the F.D.A. expert committee expressed those same concerns during a public meeting on Nov. 30.”

Vermont 1st state to mandate at-home COVID-19 test coverage: “The emergency rule covers approximately 140,000 Vermonters who purchase commercial insurance in Vermont’s individual, small and large group markets as well as the Vermont Education Health Initiative.
The rule has an eight-test monthly limit and is retroactively effective through Dec. 1…”

Omicron variant more resistant to vaccine but causes less severe covid, major South African study concludes: “The study by Discovery Health, South Africa’s largest health insurer, of 211,000 positive coronavirus cases, of which 78,000 were attributed to omicron, showed that risk of hospital admissions among adults who contracted covid-19 was 29 percent lower than in the initial pandemic wave that emerged in March 2020.
However, the study, released Tuesday, found that the vaccine from U.S. pharmaceutical giant Pfizer and German partner BioNTech provided just 33 percent protection against infection, much less than the level for other variants detected in the country.
At the same time, the vaccine may offer 70 percent protection against being hospitalized with omicron…”

Roche Gets CE Mark for Rapid Antigen Test Distinguishing COVID-19 From Flu A/B: “The test kit, which delivers results in less than 30 minutes, works with Roche’s Navify Pass software, enabling individuals and healthcare professionals to store and share their test results and vaccine status. Results from the test are available in less than 30 minutes.
The company said it intends to file for Emergency Use Authorization from the FDA early in the new year.”

Monitoring Variant Proportions: From the CDC: The delta variant accounts for about 97% of Covid cases, while the omicron variant makes up the other ~3%.

Supreme Court won’t stop vaccine mandate for New York health care workers: “The Supreme Court on Monday declined to stop New York’s coronavirus vaccination mandate for health care workers that does not include an exception for religious objectors.
As it has done in past mandate cases, the court rejected a request from doctors, nurses and other medical workers who said they were being forced to choose between their livelihoods and their faith. They said they should receive a religious exemption because the state’s rule allows one for those who decline the vaccine for medical reasons.
As is often the case in requests for emergency relief, the justices in the majority did not give a reason for declining the request to stop the order, which went into effect in November. Last month, the court also denied a similar request from health care workers in Maine.”
However: Appeals court refuses to reinstate CMS vaccine rule: “The 8th Circuit Court of Appeals on Dec. 13 denied the Biden administration's request to lift a district court's injunction that blocked the mandate, which requires COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs. The order comes after U.S. District Judge Matthew Schelp in the Eastern District of Missouri granted 10 states' request for a preliminary injunction on Nov. 29. 
The order from the appeals court applies to the 10 states that joined the lawsuit: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. A separate preliminary injunction granted in Louisiana blocked the vaccination mandate in all other states.”

Uptick in Concern over COVID Infection: “Thirty-six percent of Americans are extremely or very worried about themselves or a family member being infected with coronavirus. This is up from 25% who felt the same in October. In August, as the delta variant caused a spike in cases, 41% were concerned about infection.
While 71% of those who are vaccinated still say they’re at least somewhat worried about infections, 55% of those who are unvaccinated say they have little or no worry. Eighty-one percent of Democrats say they’re at least somewhat worried, compared with 49% of Republicans.
More than half of adults continue to stay away from large groups, wear a face mask, and avoid nonessential travel. However, fewer people are using these precautions than before vaccines were widely available. In February, more than 7 in 10 Americans reported staying away from large groups, wearing face masks, and avoiding travel.
Vaccinated Americans are more likely to take these precautions than the unvaccinated.  Democrats are also more likely than Republicans to say they’re regularly masking (72% to 33%), avoiding travel (63% to 36%), avoiding large groups (65% to 43%) and avoiding other people as much as possible (47% to 27%).”

The U.S. COVID-19 Vaccination Program at One Year: How Many Deaths and Hospitalizations Were Averted?: Highlights from a From the Commonwealth Fund report:

• “In the absence of a vaccination program, there would have been approximately 1.1 million additional COVID-19 deaths and more than 10.3 million additional COVID-19 hospitalizations in the U.S. by November 2021.

• Without the U.S. vaccination program, COVID-19 deaths would have been approximately 3.2 times higher and COVID-19 hospitalizations approximately 4.9 times higher than the actual toll during 2021.

• If no one had been vaccinated, daily deaths from COVID-19 could have jumped to as high as 21,000 per day — nearly 5.2 times the level of the record peak of more than 4,000 deaths per day recorded in January 2021.”

About pharma

10 of the largest pharma companies, ranked by 2020 revenue: FYI

About healthcare IT

Computer-, smartphone-based treatments effective at reducing symptoms of depression: “Researchers conducted a meta-analysis of 83 studies testing digital applications for treating depression, dating as far back as 1990 and involving more than 15,000 participants in total, 80% adults and 69.5% women. All of the studies were randomized controlled trials comparing a digital intervention treatment to either an inactive control (e.g., waitlist control or no treatment at all) or an active comparison condition (e.g., treatment as usual or face-to-face psychotherapy) and primarily focused on individuals with mild to moderate depression symptoms. 
Overall, researchers found that digital interventions improved depression symptoms over control conditions, but the effect was not as strong as that found in a similar meta-analysis of face-to-face psychotherapy. There were not enough studies in the current meta-analysis to directly compare digital interventions to face-to-face psychotherapy, and researchers found no studies comparing digital strategies with drug therapy.”

The Digital Experience is the Key Driver of Growth and Patient Retention, According to Press Ganey’s 2021 Consumer Report: “According to the analysis:

• All generations are increasingly shopping online for healthcare. 44% of baby boomers and 60% of millennials and Gen Z prefer researching healthcare providers on their smartphone or tablet, representing a 27% and 13% increase from 2019, respectively.

• Digital drives patient choice. In fact, they rely on digital resources more than twice as much as provider referrals when choosing a healthcare provider. On average, consumers use three different websites during their healthcare research process and five reviews before making a decision.

• Search engines are just the start. Among the top five websites used, consumers rely on a brand’s website, WebMD, Healthgrades and Facebook the most to research a provider.

• Online reviews prevent referral leakage. 83% of patients go online to read reviews about a provider after they receive a referral. 84% would not see their referred provider if they had less than a four-star rating.

• Customer service is the new bedside manner. Assuming quality care is received, patients rate ‘customer service’ (71%) and ’communication’ (64%) as more important than even ‘bedside manner’ when it comes to rating a five-star experience.

• Telehealth isn’t going anywhere anytime soon. More than one-third of patients have used telehealth in the past year—a 38% increase since 2019—and usage surged among baby boomers during the same period.”

A machine and human reader study on AI diagnosis model safety under attacks of adversarial images: “We perform a study to investigate the behaviors of an AI diagnosis model under adversarial images generated by Generative Adversarial Network (GAN) models and to evaluate the effects on human experts when visually identifying potential adversarial images. Our GAN model makes intentional modifications to the diagnosis-sensitive contents of mammogram images in deep learning-based computer-aided diagnosis (CAD) of breast cancer. In our experiments the adversarial samples fool the AI-CAD model to output a wrong diagnosis on 69.1% of the cases that are initially correctly classified by the AI-CAD model. Five breast imaging radiologists visually identify 29%-71% of the adversarial samples. Our study suggests an imperative need for continuing research on medical AI model’s safety issues and for developing potential defensive solutions against adversarial attacks.”

Scripps' Epic EHR automates supply price markups up to 675% : “Scripps Memorial Hospital's Epic EHR uses an automated tool to mark up prices of supplies between 575 and 675 percent in real time within the EHR…”

Satisfaction with telemedicine takes a tumble but still comes out on top, new report says: “Despite overall satisfaction of consumers with telemedicine, patients were less impressed by the services this year as compared to last, a new report from Rock Health published Dec. 13 reveals. 
Rock Health conducted a digital health consumer adoption survey that asked 7,980 U.S adults about their relationship to digital health. 
It found that satisfaction with telemedicine decreased in 2021. In 2020, 53 percent of respondents reported higher satisfaction with live video telemedicine compared to in-person interactions. However, in 2021, only 43 percent of respondents reported the same. 
Physicians also reported being less satisfied with telehealth, with 58 percent of physicians surveyed viewing telehealth more favorably since the pandemic in 2021 as compared to 64 percent in 2020.”

Today's News and Commentary

About healthcare M&A

Health services: Deals 2022 outlook: Some highlights from this PWC report:
”Deal volumes rose by an extraordinary 56% in the 12 months through November 15 versus 2020, with particularly high growth in physician medical groups, managed care and rehabilitation subsectors.
Deals appetite has persisted despite high multiples — the sector-wide mean enterprise value to EBITDA multiple for the period reached 15.2x.
In the same period, the sector has seen nine megadeals valued at $5 billion or more, plus traditional IPOs and IPOs backed by special purpose acquisition companies (SPACs).
Deals are being driven by forces including capital availability, regulatory pressures, searches for value, resilience imperatives and evolving value chain power dynamics.”

Baxter Completes Acquisition of Hillrom, Creating ~$15 Billion Global Medtech Leader: Read the announcement for details.

Pfizer spurs immuno-inflammatory pipeline with $6.7-billion Arena buy: “The deal announced Monday bolsters Pfizer's pipeline with the addition of development-stage therapeutic candidates in gastroenterology, dermatology and cardiology, including the next-generation oral S1P receptor modulator etrasimod that it expects will contribute to growth ‘through 2025 and beyond.’”

The top 10 M&A targets in medtech for 2022: Read the article for more information on companies in the list.

About Covid-19

U.S. COVID-19 deaths reach 800,000 as Delta ravaged in 2021: Data as of yesterday.

TWO-THIRDS OF STATE MEDICAL BOARDS SEE INCREASE IN COVID-19 DISINFORMATION COMPLAINTS: “The Federation of State Medical Boards (FSMB) has released findings from its 2021 annual survey of its member state medical boards….
When asked about complaints and disciplinary actions related to COVID-19, the survey found:

• 67% have experienced an increase in complaints related to licensee dissemination of false or misleading information

• 26% have made or published statements about the dissemination of false or misleading information

• 21% have taken a disciplinary action against a licensee disseminating false or misleading information”

The Big Vaccine Pivot: Merck Falters on Covid-19 Shots, Then Makes One for Rival J&J: “The Johnson & Johnson -Merck partnership, which the companies announced in March, is now bearing fruit to expand the world’s vaccine supply. After a frantic ramp-up that involved scouting for raw materials, buying equipment and upgrading plants all at the same time, the first Merck-made shots shipped Friday.
Merck is churning out more than 500,000 doses daily for use outside the U.S., including countries desperate for shots.”

Court ruling is a blow to restaurants' COVID claims: “In a sweeping set of rulings, the 7th U.S. Circuit Court of Appeals determined that governmental actions closing or restricting businesses in the early months of the pandemic weren’t losses that insurers have to cover.
The decisions in six cases, made public today, upheld decisions by lower courts to dismiss suits claiming damages by an array of plaintiffs, including the Ritz-Carlton Hotel in Dallas. But their sweeping nature means that the many other cases pending in lower courts… likely will fail over the same issues.”

About health insurance

Affordability of Medical Care Among Medicare Enrollees: “In a nationally representative survey of 13 171 Medicare enrollees that asked several questions about the affordability of their medical care, the overall reported prevalence of ever delaying care during 2017 owing to worries about cost was 11%; the prevalence of having problems paying medical bills was also 11%, and 16% of the respondents experienced 1 of these 2 concerns or both. Unaffordability of care was associated with lower incomes, worse health, and being younger than 65 years with long-term disability.”

MedPAC Likely To Support Pay Increase For Hospitals In 2023: Skilled nursing, home health and inpatient rehabilitation facilities could see 5% base pay decreases. Physicians, ambulatory surgical centers and hospices may see no change in pay from 2022.
Post-acute care providers and stakeholders that could be facing pay freezes said they’re disappointed in MedPAC’s draft proposals. MedPAC’s own commissioners agreed with most recommendations staff presented. However, several members had concerns about leaving physician pay flat in 2023. Recommendations will come to an official vote at next month’s meeting.
MedPAC staff suggested updating hospital payment by the amount determined under current law, which is expected to be 2% for 2023.”

Miami Resident Charged with Committing $38 Million Health Care Fraud Scheme, Spending Proceeds on Beachfront Condos and Luxury Vehicles: “According to allegations in the federal grand jury indictment, from February 2015 through July 2021, 63-year-old Armando Valdes owned and operated Gasiel Medical Services, Corp. (“Gasiel”) a medical clinic in Miami, Florida. It is alleged that Gasiel submitted approximately $38 million in false and fraudulent claims to United and Blue Cross for infusions of Infliximab which were medically unnecessary and not provided to patients as billed.”
Such fraud cannot occur in a capitated arrangement where the provider is responsible for in-office expenses.

Centene May Sell Its International Business As Health Insurer Expands In The U.S.: “Centene, which is known for providing government-subsidized health insurance in the U.S., said Friday it is “reviewing its non-core assets as part of its ongoing portfolio optimization processes, including evaluating strategic alternatives for its international business.”
The announcement, made as part of Centene’s annual investor day, comes as the company is on the verge of bolstering its U.S. health insurance offerings with Magellan Health, which sells and manages behavioral health services. Centene is hoping to close its Magellan Health acquisition by the end of this year, the company said.”

About the public’s health

Infant Mortality in the United States, 2019: Data From the Period Linked Birth/Infant Death File: Among the findings: “A total of 20,927 infant deaths were reported in the United States in 2019, down 3% from 2018. The U.S. infant mortality rate was 5.58 infant deaths per 1,000 live births, a historic low for the country, although not significantly different from the rate of 5.67 in 2018. The neonatal mortality rate declined to 3.69 in 2019 from 3.78 in 2018, while the postneonatal mortality rate was unchanged from 2018 at 1.89. The mortality rate declined for infants of non-Hispanic white women in 2019 compared with 2018; declines in rates for the other race and Hispanic-origin groups were not significant. The 2019 infant mortality rate for infants of non-Hispanic black women (10.62) was more than twice as high as that for infants of non-Hispanic white (4.49), non-Hispanic Asian (3.38), and Hispanic (5.03) women… Infant mortality rates by state for 2019 ranged from a low of 3.21 in New Hampshire to a high of 8.71 in Mississippi.”

Beware of Vaping Products with Unproven Health Claims: From the FDA: “The U.S. Food and Drug Administration wants consumers to know certain “wellness” vaping products containing vitamins and/or essential oils are being illegally sold with unproven claims and could be harmful if used. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases.”

About hospitals and health systems

2 US health systems plan international expansions: Read the article for details of the UPMC and Cleveland Clinic plans.

About healthcare professionals

2021 Fall Applicant, Matriculant, and Enrollment Data Tables: Applications are up to record numbers for all categories. Currently,  52.7% of enrollees are women. “Black or African American” enrollment is up almost 10%.

About healthcare IT

Digital HTN, Diabetes Monitoring Program a Boon for Patients: “A digital health program for hypertension and diabetes was associated with improved patient outcomes, a clinical pharmacist reported.
While 26% of hypertension patients receiving usual care achieved blood pressure control after 6 months, 75% of those in the digital health program met that goal in the same time frame in 2018, Heather Aaron, PharmD, of Ochsner Health in New Orleans, reported…
Patients with diabetes experienced improved hemoglobin A1c as well, with the average going from 7.3% at baseline to 6.7% after 6 months in the digital health program…”

What devices like Apple, Google smartwatches are beginning to display about our health: “The global market for wearable health and fitness devices — including sensor-laden watches, wrist bands, rings, skin patches, eyeglasses and clothing — reached more than $36 billion in 2020 and is projected to reach over $100 billion by 2028…
Now, nearly 30% of Americans now use a wearable health care device, many of which now have the capabilities to track, monitor and transmit data on heart rate and rhythm, blood pressure, body temperature, blood sugar levels, quality of sleep and even early warning signs of Covid-19 infection.”
The article has many good examples of current and emerging technologies.

About healthcare quality

Longitudinal Content Analysis of the Characteristics and Expected Impact of Low-Value Services Identified in US Choosing Wisely Recommendations: “In this qualitative study of 626 recommendations, the plurality identified low-value imaging and laboratory studies, services in the clinical contexts of healthy patients or those with a chronic condition, and services that were low cost and revenue neutral for the given society. Nearly half of identified low-value services had high direct harm potential, while 62% had high potential for cascades (ie, triggering downstream services).”

Today's News and Commentary

About hospitals and health systems

How the 3 largest nonprofit systems fared in Q1: “The largest nonprofit health systems, Ascension, CommonSpirit Health and Trinity Health, reported higher revenue in the first quarter of fiscal year 2022 than in the same period a year earlier.” The article provides more details for each system.

The 11 most expensive hospital capital projects in 2021: “Eleven capital projects of more than $1.5 billion were announced, broke ground or were completed in 2021.” Amazing that these expensive projects went ahead during the Covid pandemic.

About healthcare technology

Chan Zuckerberg Initiative to pour $3.4B over 10 years into AI, imaging and other tech to unravel biomedical challenges: “The philanthropic initiative—led by the husband-and-wife duo of Facebook founder Mark Zuckerberg and Priscilla Chan, M.D., formerly a practicing pediatrician—unveiled this week a 10-year plan to invest $3.4 billion in the development of new technologies and tools that help improve our understanding of human health and disease.
Between $800 million and $1 billion of the new funds will go to the Biohub… {the] San Francisco-based research hub launched in 2016 with an initial commitment of about $600 million. Its first projects included the construction of the Cell Atlas, a map of the various types of cells that control each major organ, and the creation of the Infectious Disease Initiative to develop new diagnostic tests and vaccines to treat HIV, Ebola, Zika and other fast-spreading diseases.”

About health insurance

Senate votes to avert Medicare cuts: “The bill halts a mandatory 2 percent federal Medicare spending sequester until April 2022 and stops a 4 percent statutory pay-as-you-go sequester. Both sequesters are meant to limit federal spending.
The bill also reduces the mandatory Medicare sequester to 1 percent from April through June of 2022 and includes a 3 percent increase in pay for providers in the Medicare physician fee schedule. The package also delays the start of the radiation oncology model until Jan. 1, 2023, to give participants the best chance to improve cancer care outcomes…
The Senate approved the bill in a 59-35 vote. The House approved the bill Dec. 7 in a 222-212 vote. It now heads to President Joe Biden.”

Doctors and Hospitals Make Late Bid to Change Surprise Billing Ban: “Three weeks before a new ban on surprise medical billing is set to start, hospital and doctor groups have filed suit to block part of it.
The suit, from the American Medical Association, the American Hospital Association and a handful of individual hospitals and providers, argues that regulators in the Biden administration have misread the law’s language — and that their faulty interpretation will harm medical providers.
The lawsuit does not seek to gut the law’s consumer protections, but could influence contract negotiations between insurers and health care providers. If successful, the lawsuit could influence which doctors and hospitals choose to go in network with insurers, and could lead to higher insurance premiums.”

Affordable Care Act exchanges seeing record interest in heavily subsidized 2022 coverage: “Plan selections in the 33 states that use the federal exchange, Healthcare.gov, are up 5% from an essentially comparable period last year, the agency said. The data is for the first five weeks of open enrollment, which began November 1 and runs through January 15, a month longer than under the Trump administration.
In the 12 states that have not expanded Medicaid to low-income adults, sign ups have increased 9%. Plan selections are up 20% in Texas and 9% in Florida, the two largest markets on the federal exchange.”

5 payers tagged by OIG for coding, reimbursement errors in 2021: Read the article for details.

Anthem-backed Hydrogen Health rolls out virtual primary care services for insurers, employers: “Hydrogen Health rolled out its services with Anthem this past summer and is now expanding to multiple Fortune 500 employers and large regional health plans, company executives said, with a plan to be live for an additional 10 million people by the end of 2022.
Hydrogen Health is a new venture from New York-based K Health, backed by an Anthem investment and funds managed by investment firm Blackstone that aims to lower healthcare costs and make care more accessible.”

Geographic Variation in Medicare Fee-for-Service Health Care Expenditures Before and After the Passage of the Affordable Care Act: “This analysis of geographic variation in per-beneficiary health care expenditures within the Medicare fee-for-service system has 3 notable findings. First, we observed a decline in geographic variation in total expenditures from 2007 to 2018. Whereas per-beneficiary monthly expenditures were $415 higher in the top vs bottom deciles in 2007, they were only $361 higher in 2018. Notably, we found reductions in geographic variation were concentrated in the highest-spending decile—the ratios of the 9th and 8th to the lowest-spending deciles were more constant during this period—showing that reductions in relative spending were not uniform across all higher-spending deciles but rather focused on outlier regions. Second, the decline in geographic variation appears to have begun in 2012, soon after Medicare began implementing value-based payment policies and increased antifraud enforcement after the ACA. Third, the types of services that accounted for the decrease in geographic variation were postacute care (which declined as a proportion of total expenditures), and most of the decline in geographic variation in postacute care was related to home health care. Notably, for both hospital and physician services, geographic variation was unchanged over the study period.”

About pharma

Utilization of Generic Cardiovascular Drugs in Medicare’s Part D Program: “Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings.”

House Democrats find in three-year investigation that drug prices are ‘unsustainable, unjustifiable and unfair’: “The findings, released Friday, show that companies studied by the committee raised prices of common brand-name drugs during the past five years by nearly four times the rate of inflation. The report seeks to debunk industry contentions that companies’ pricestrategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments….
In a counterpunch, the Oversight committee’s Republicans issued their own drug-industry report, based on a less exhaustive look at companies known as pharmacy benefit managers, which act as go-betweens to manage drug benefits on behalf of private insurers, Medicare drug plans and other payers. The pharmaceutical industry and other critics have contended for years that PBMs, as they are known, are a major reason for the growth of drug spending because they receive undisclosed payments — called rebates — based on a medicine’s list price, so the higher the price the greater the payment.”

Federal Jury Convicts Pharmacy Owner for Role in $174 Million Telemedicine Pharmacy Fraud Scheme: This case is a rare example of a multiyear scam that did not target federal programs. “According to court documents and evidence presented at trial, Bolos and his co-conspirators, Andrew Assad, Michael Palso, Maikel Bolos, Larry Smith, Scott Roix, HealthRight LLC, Mihir Taneja, Arun Kapoor, and Sterling Knight Pharmaceuticals, as well as various other companies owned by them, deceived pharmacy benefit managers (PBMs), such as Express Scripts and CVS Caremark, regarding tens of thousands of prescriptions. The PBMs processed and approved claims for prescription drugs on behalf of insurance companies. Bolos and his co-conspirators defrauded the PBMs into authorizing claims worth more than $174 million that private insurers such as Blue Cross Blue Shield of Tennessee, and public insurers such as Medicaid and TRICARE, paid to pharmacies controlled by the co-conspirators.”

About the public’s health

Becerra names incoming acting NIH director: “Lawrence Tabak, who currently serves as the principal deputy director at NIH, will take on the acting position starting on Dec. 20, while the administration searches for Collins’s permanent replacement, the HHS secretary said in an announcement.”

Association of Air Pollution and Physical Activity With Brain Volumes: “Physical activity is associated with beneficial brain outcomes, while AP is associated with detrimental brain outcomes. Vigorous physical activity may exacerbate associations of AP with white matter hyperintensity lesions, and AP may attenuate the beneficial associations of physical activity with these lesions.” Beneficial individual efforts are balanced out by public errors.

Supreme Court lets Texas abortion law continue but says providers can sue: “In this latest decision, court said in an 8-1 vote that abortion providers should be allowed to sue in federal court, with only Justice Clarence Thomas saying in a dissent that he would have thrown out the providers' case.
By a 5-4 vote, the Supreme Court's conservative majority said that the providers could not sue state court clerks, as clinics had sought to do in their efforts to short-circuit the private state court litigation that could be brought against them for violating the six-week ban. Chief Justice John Roberts said that the Court should have allowed lawsuits to proceed against those and other officials.”
In a related article: Judge says Texas abortion law’s enforcement mechanism unconstitutional: "The enforcement mechanism for Texas’s abortion ban, which is the most restrictive in the nation and effectively outlaws the procedure, violates the Texas constitution, a state judge ruled Thursday.
While a win for abortion rights advocates, the narrow decision by District Judge David Peeples of Austin does not include an injunction that would halt litigation against doctors or others who “aid or abet” an abortion.”

NHS waiting list in England hits record high in October: A cautionary note fro those advocating a national health scheme like the one in England: “The number waiting for non-emergency NHS hospital treatment has risen to 6m, the highest since records began almost 15 years ago, underlining the health service’s fragility as it braces for the consequences of the new Omicron coronavirus variant. Official data from NHS England published on Thursday showed a large jump in the backlog in October, with about 35 per cent of patients waiting more than 18 weeks to start treatment, against a target of just 8 per cent.”

IDF Diabetes Atlas 10th edition 2021: From the International Diabetes Federation: “Findings of the current 10th edition confirm that diabetes is one of the fastest growing global health emergencies of the 21st century (see Map 1). In 2021, it is estimated that 537 million people have diabetes, and this number is projected to reach 643 million by 2030, and 783 million by 2045. In addition, 541 million people are estimated to have impaired glucose tolerance in 2021. It is also estimated that over 6.7 million people aged 20–79 will die from diabetes-related causes in 2021. The number of children and adolescents (i.e. up to 19 years old) living with diabetes increases annually. In 2021, over 1.2 million children and adolescents have type 1 diabetes. Direct health expenditures due to diabetes are already close to one trillion USD and will exceed this figure by 2030.”

About Covid-19

US government has granted vaccine mandate exceptions to 165,000 workers: “8% of federal employees remain unvaccinated against Covid-19 despite November mandate.”

Austrians who refuse Covid jabs face fines of up to €3,600: “Government plans to make vaccination compulsory for everyone aged above 14 from February.”

Covax promised 2 billion vaccine doses to help the world’s neediest in 2021. It won’t even deliver even half that.: “The U.N.-led initiative is now racing to deliver 800 million doses by the end of the year, according to interviews with senior officials involved in Covax, which includes the World Health Organization and other groups. Even if that benchmark is met, it will be a far cry from the 2.3 billion doses hoped for in January by a program designed to counter a glut of vaccines in wealthy nations.
Covax lowered its estimate of doses delivered in 2021 to between 800 million and 1 billion doses late this year after a range of complications with supply and delivery.“

AstraZeneca’s COVID-19 Long-Acting Antibody Combo Snags EUA: “The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems.
The combination tixagevimab/cilgavimab treatment is indicated for people with moderate-to-severe immunocompromise caused by a medical condition or immunosuppressive drugs who may be unable to mount a proper immune response to a COVID-19 vaccine, as well as those who shouldn’t receive a coronavirus vaccine at all.”

Today's News and Commentary

COVID cases spike even as US hits 200M vaccine milestone: “The number of Americans fully vaccinated against COVID-19 reached 200 million Wednesday amid a dispiriting holiday-season spike in cases and hospitalizations that has hit even New England, one of the most highly inoculated corners of the country.
New cases in the U.S. climbed from an average of nearly 95,000 a day on Nov. 22 to almost 119,000 a day this week, and hospitalizations are up 25% from a month ago. The increases are due almost entirely to the delta variant, though the omicron mutation has been detected in about 20 states and is sure to spread even more.
Deaths are running close to 1,600 a day on average, back up to where they were in October. And the overall U.S. death toll less than two years into the crisis could hit another heartbreaking milestone, 800,000, in a matter of days.”

Omicron may require fourth vaccine dose sooner than expected, Pfizer says: “Albert Bourla, Pfizer’s chief executive, had projected that a fourth dose might be needed 12 months after a third shot. But he said on CNBC’s ‘Squawk Box’ that the timeline might need to be moved up. One of the company’s top scientists recently said a fourth shot — possibly one targeting omicron — is likely to be necessary.”

U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail: “The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca's antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.”

Senate votes to nix Biden's vaccine mandate for businesses: “The Senate on Wednesday voted to nix President Biden’s vaccine mandate for larger businesses, handing Republicans a symbolic win.
Senators voted 52-48 on the resolution, which needed a simple majority to be approved. Democratic Sens. Jon Tester (Mont.) and Joe Manchin (W.Va.) voted with Republicans, giving it enough support to be sent to the House. 
The resolution faces an uphill path in the House, where Republicans aren’t able to use a similar fast-track process to force a vote over the objections of Democratic leadership. Instead, Republicans are hoping to get the simple majority needed to force a vote through a discharge petition, which will require support from a handful of House Democrats.”

FDA authorizes Pfizer-BioNTech coronavirus vaccine booster shots for 16- and 17-year-olds amid omicron threat: “Federal regulators Thursday authorized booster shots of Pfizer-BioNTech’s coronavirus vaccine for 16- and 17-year-olds, a step that could bolster protection against delta, the dominant variant in the United States, and the emerging omicron version.”

Health Experts Worry CDC’s Covid Vaccination Rates Appear Inflated: “CDC as of Dec. 5 has recorded more seniors at least partly vaccinated — 55.4 million — than there are people in that age group — 54.1 million, according to the latest census data from 2019. The CDC’s vaccination rate for residents 65 and older is also significantly higher than the 89% vaccination rate found in a poll conducted in November by KFF.”
Other discrepancies are also reported.

The Coronavirus Attacks Fat Tissue, Scientists Find: “From the start of the pandemic, the coronavirus seemed to target people carrying extra pounds. Patients who were overweight or obese were more likely to develop severe Covid-19 and more likely to die.
Though these patients often have health conditions like diabetes that compound their risk, scientists have become increasingly convinced that their vulnerability has something to do with obesity itself.
Now researchers have found that the coronavirus infects both fat cells and certain immune cells within body fat, prompting a damaging defensive response in the body.”

About hospitals and health systems

City of Hope to acquire Cancer Treatment Centers of America for a reported $390M: “Hospital system City of Hope is acquiring Cancer Treatment Centers of America to build a national, integrated cancer research and treatment system.
Financial details of the acquisition were not disclosed, but Reuters reported the deal was valued at $390 million.”

About health insurers

Bright Health banks $750M investment from Cigna Ventures, New Enterprise Associates: “Insurtech startup Bright Health has secured a $750 million capital investment that includes funding from Cigna Ventures.
Cigna's investment arm is a new backer for the company. Bright Health's largest shareholder, New Enterprise Associates, will also participate as a co-investor. The funds will be used to help Bright Health continue to grow and enhance its differentiated alignment model.”
In a related article: Why Cigna Keeps Partnering With Its Competitors: “These partnerships with smaller insurers and tech companies help Cigna bridge blindspots in its insurance products and add new customers to its health services division, allowing it to better compete and mimic the strategy of larger insurers like UnitedHealth Group, said Rick Kes, a healthcare industry senior analyst at RSM.”

How ACA Marketplace Premiums Are Changing by County in 2022: “Premiums for ACA Marketplace benchmark silver plans are decreasing on average across the U.S. in 2022 for the fourth consecutive year. However, premium changes vary widely by location and by metal level, with premiums increasing in several cases. As most enrollees receive significant premium subsidies on the ACA Marketplaces, the net premium amount an exchange enrollee pays out-of-pocket depends on their income and the difference in the cost between the benchmark plan (second-lowest silver plan) and the premium for the plan they choose.”
The article has a helpful interactive U.S. map that gives changes for plans by county.

About pharma

In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs: From Urban Institute research:
”We find the following:
—Nearly 13 million adults delayed getting or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.
—About 1 in 10 adults who were uninsured all year (9.5 percent) or part of the year (11.6 percent) reported unmet prescription drug needs, compared with 4.9 percent of Medicare beneficiaries, 3.0 percent of privately insured adults, and 5.6 percent of nonelderly adults with Medicaid.
—For both Medicare beneficiaries and privately insured adults, unmet prescription drug needs were most common among women, people with low incomes, and people with multiple chronic health conditions. Nearly all Medicare beneficiaries and more than 8 in 10 privately insured adults with unmet needs have been diagnosed with a chronic condition such as high blood pressure, high cholesterol, stroke, diabetes, arthritis, and respiratory illnesses.
—More than one-quarter of adults with Medicare (25.4 percent) and 5.3 percent of privately insured adults spent more than 1 percent of their family incomes on their individual out-of- pocket prescription drug costs. More than 3 percent of Medicare beneficiaries—and nearly 7 percent of beneficiaries with unmet prescription drug needs—spent more than 10 percent of their family incomes on prescription drugs.”

A pilot trial to evaluate the feasibility, acceptability, and accuracy of a digital pill system to measure PrEP adherence in men who have sex with men [MSM] who use substances: “Digital pill systems (DPS) comprise a radiofrequency emitter integrated into a gelatin capsule containing PrEP, which transmits data to a wearable Reader following ingestion, thereby enabling direct, real-time adherencemeasurement. This study evaluated the feasibility, acceptability, and accuracy of a DPS to measure PrEP adherence…
DPS are a feasible, acceptable, and accurate method of measuring PrEP adherence in MSM with substance use. Future investigations should incorporate DPS into behavioral interventions targeting nonadherence.”
In a related article from the CDC: PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2021 UPDATE: “In anticipation of likely FDA approval of a PrEP indication for cabotegravir (CAB) in late 2021, we added a new section about prescribing PrEP with intramuscular injections of CAB every 2 months for sexually active men, women, and transgender persons with indications for PrEP use.”

$56K Alzheimer’s drug avoiding Biden’s cost curbs, for now: “The medication known as Aduhelm would be protected from Medicare price negotiations for more than a decade under the Democratic drug pricing compromise before Congress, part of Biden’s social agenda legislation. That’s because the bill doesn’t allow Medicare to negotiate over newly launched drugs, providing a window for drugmakers to recoup investments in research and development. Biologics such as Aduhelm get 13 years of protection.”

Drug Company Settles with N.Y. for $200 Million in Sprawling Opioid Case: “The settlement with Allergan, a company that has made opioids but whose most well-known product is Botox, is the latest agreement in a trial jointly argued by New York State and two counties that began in June.”

About healthcare IT

10 biggest patient data breaches in 2021: “In 2021, 578 healthcare organizations reported to HHS more than 41.45 million individuals being affected by data breaches.”

Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers: CMS is putting on hold enforcement of some interoperability requirements. “This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.”

About healthcare policy

Biden promised to reverse Trump's health policies. He's done that -- mostly.: A really good review of the headline’s topic. The major actions still needed are:

• ”The rule that got the most pushback from Democrats: Trump’s expansion of short-term health plans, which typically don’t cover pre-existing conditions.

• A regulation expanding so-called association health plans — which allows businesses to band together to buy health coverage — has been stalled in the courts. A federal judge still hasn’t ruled on the measure, despite hearing the case back in 2019, and the Biden administration told the court as recently as this week that the administration is still considering the matter.

• The last regulation allows for employers to provide subsidies for their workers to buy health coverage on the individual market.”

About the public’s health

New Zealand’s plan to end smoking: A lifetime ban for youth: “New Zealand has been at the front of social and public health initiatives. This one is the latest: New Zealand’s government believes it has come up with a unique plan to end tobacco smoking — a lifetime ban for those aged 14 or younger.
Under a new law the government announced Thursday and plans to pass next year, the minimum age to buy cigarettes would keep rising year after year.
That means, in theory at least, 65 years after the law takes effect, shoppers could still buy cigarettes — but only if they could prove they were at least 80 years old.” 
Unfortunately, this plan would not be politically feasible here ( less than 0.01% of agricultural land in NZ is devoted to tobacco cultivation). Further, it would impinge on our Constitutional right to abuse our bodies at the public’s expense.

Today's News and Commentary

About hospitals and health systems

2021 Healthcare Consumer Experience Study: Among the findings: “More than one-third (35%) of survey respondents say they have changed (or would change) healthcare providers to get a better digital patient administrative experience. And one-third (33%) have changed or would change payers to get a better digital member experience.”

CONSUMER EXPERIENCE TRENDS IN HEALTHCARE 2021: In a different study (this one by Press Ganey), below are some highlights:

“Digital drives choice: Patients rely on digital resources 2.2x more than provider referrals when choosing a healthcare provider.
Referral leakage: 84% would not see a referred provider if they were rated under 4 stars.
The rise of virtual health: Over 1/3 of patients have used telehealth in the past year—a 337.6% increase since 2019.
Patient as customer: Assuming quality care, patients rate “customer service” (70.8%) and “communication” (63.4%) as more important than even “bedside manner” when it comes to a 5-star experience.
Shopping for healthcare: On average, consumers use three different websites during their healthcare research process and read 51⁄2 reviews before making a decision.”

CMS to roll out 'birthing-friendly' hospital tag on Care Compare site: “The Biden administration wants to add a ‘birthing-friendly’ designation to facilities on the Centers for Medicare & Medicaid Services’ (CMS') Care Compare website.
The designation, announced Tuesday as part of a larger call to action from the White House to address maternal care, would apply to hospitals that provide perinatal care and participate in a maternity care quality improvement collaborative.
CMS is also encouraging states to take advantage of an option in the American Rescue Plan Act to provide a year of postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program.”

About Covid-19

Booster doses of Pfizer-BioNTech vaccine will be critical against omicron, companies’ study suggests: “The early data, which is not yet peer reviewed or published, suggests that two shots may not be sufficient to prevent infection from omicron and echoes a finding published Tuesday afternoonby leading scientists in South Africa.
Both studies suggest that higher levels of antibodies — whether triggered by a booster shot or a previous infection in addition to vaccination — may restore protection.”

If you are looking for reasons why we have not controlled the Covid-19 pandemic, the two articles below should help clarify the problem:
Losing your job because of vaccine mandates? You can collect unemployment benefits in these states: “At least three red states -- Iowa, Tennessee and Florida -- have recently passed laws extending eligibility to these folks as part of broader measures restricting employer vaccine mandates.
Kansas' GOP-led legislature approved a similar bill that Gov. Laura Kelly, a Democrat, recently signed. And in Arkansas, which is controlled by Republicans, a law curtailing vaccine mandates will take effect in January.
Other states, including Wyoming and Wisconsin, have looked into such provisions, and more are expected to consider similar legislation when lawmakers return to their capitols in January.”

Half of Americans Back Biden’s Vaccine-or-Test Mandate for Private Sector, WSJ Poll Finds: “Fifty percent of voters said they support Mr. Biden’s vaccine requirements for the private sector, which direct companies with 100 or more employees to require workers to either get vaccinated or tested weekly, while 47% oppose them. A slightly larger share of voters support state and local vaccine mandates for public safety workers, such as police officers, firefighters and first responders, with 55% in favor and 44% opposed.
Voters were also divided on whether the Covid-19 vaccine should be mandatory for school-aged children, with more people in favor of requiring vaccines for older children. Fifty-one percent of respondents said they would support schools requiring that children 12 and older get vaccinated, while 45% said they were opposed to the idea. Voters were evenly split, 48%-48%, on whether schools should mandate vaccines for children ages 5 to 11.”

6 states account for 60% of US COVID-19 hospitalizations: “Michigan, Ohio, Indiana, Pennsylvania, New York and Illinois are mostly driving this increase. These states make up 35 percent of the population among states with increasing hospitalizations, but comprise 60 percent of new hospital beds filled between Nov. 10 and Dec. 5, according to an NBC News analysis of HHS data.”

WHO Says ‘No’ to Convalescent Plasma for Nonsevere COVID-19: “A review of 16 different trials that included 16,236 COVID-19 patients with nonsevere, severe and critical COVID-19 infection found that the plasma did not improve survival or reduce the need for supplemental oxygen for nonsevere patients, a WHO panel found.”

About the public’s health

United Health Foundation report: U.S. deaths rose 17% between 2019 and 2020: “While overall U.S. deaths increased 17% from 2019 to 2020, people also reported a 13% increase in high health status during the same time.
The report examined more than 80 measures from 30 data sources, with the goal of illuminating the strengths and pitfalls of this country’s health. It offers a look into disparities by age, gender, race, ethnicity, geography, education and income level. The report is available at AmericasHealthRankings.org, as is an interactive breakdown of the data.”
The report also has rankings of states. Colorado is the healthiest, West Virginia the least healthy.

About health insurance

House passes bill that delays 6% in Medicare cuts, postpones radiation oncology model: “The House passed by a vote of 222 to 212 a bill that delays 6% in Medicare cuts set to go into effect Jan. 1 and reduce most of a 3.75% cut to physicians, handing providers a major win they have been fervently lobbying Congress for.”
The action was a delay that still needs to clear the Senate. Read the article for more details.

UnitedHealthcare Must Pay TeamHealth $62 Million For Shortchanging Clinicians, Jury Says: “UnitedHealthcare must pay $62.65 million in total damages for shortchanging TeamHealth clinicians, a Las Vegas jury decided Tuesday.
The jury unanimously found the nation’s largest insurer guilty of fraud and unjust enrichment, saying it had formed and violated an implied contract with TeamHealth and engaged in unjust and oppressive claims practices. The private equity-backed provider group initially demanded $100 million in punitive damages when it alleged the insurer reimbursed clinicians at unlawfully low rates. The jury awarded the plaintiff $60 million. With the $2.65 million TeamHealth won in compensatory damages last week, UnitedHealthcare’s total obligation reached $62.65 million. UnitedHealthcare will reportedly appeal the ruling.”

About pharma

Vyera Pharmaceuticals to pay $40M in price-gouging settlement: “As part of a drug-pricing inflation settlement, Vyera Pharmaceuticals will pay $40 million in relief to victims affected by its price-gouging scheme involving the lifesaving drug Daraprim, the Federal Trade Commission announced Dec. 7. 
The FTC and seven state co-plaintiffs filed the Dec. 7 court order after a January 2020 complaint alleging Vyera, former CEO Martin Shkreli and his associate Kevin Mulleady engaged in anticompetitive practices when they raised the price of the drug from $17.50 to $750 per tablet after acquiring it in 2015.”

About healthcare IT

Microsoft’s $19.7B Nuance buy hits a snag with EU antitrust probe: “The E.U.’s antitrust regulator began issuing the questionnaires after the companies submitted the acquisition for approval last month. It currently has until Dec. 21 to either officially widen the probe or give the all-clear.
Either way, the transaction is seemingly no longer on track to close by the end of the year, as Microsoft and Nuance initially planned when they announced their agreement in April.”

Amazon launches new elder care subscription service Alexa Together with emergency assistance, fall detection: “Amazon has officially launched Alexa Together, a subscription-based service helping caregivers provide remote support to elderly loved ones, the tech giant said Tuesday.
First announced in late September, the service uses Amazon’s range of Echo devices with new features like fall detection and 24/7 emergency assistance supporting the health and wellbeing of older users.
Family members can choose to receive notifications through the Alexa app when their loved one uses their device for the first time each day and will be contacted along with emergency services if the user calls for help.”

Today's News and Commentary

About health insurance

Latest Findings Indicate Payment Incentive for Providing Primary Care in the Home Has Not Had Desired Impacts: “The Independence at Home (IAH) Demonstration tests whether implementing a payment incentive and delivering home based primary care leads to reductions in overall spending and improvements in quality of care for chronically ill and disabled Medicare beneficiaries. Mathematica’s evaluation of the first six years of IAH provided no compelling evidence that the IAH payment incentive reduced Medicare spending or hospital use for high-need patients of practices participating in the demonstration. When examining dually eligible beneficiaries who received home-based primary care from any provider, Mathematica’s analysis found lower expenditures on institutional care and higher expenditures on home-based services—but no reduction in total Medicare or Medicaid spending.”

Provider groups urge feds to change dispute process, good faith estimates in surprise billing rule: “The No Surprises Act calls for the creation of an independent arbitration process in case payers and providers cannot come to terms on an out-of-network charge. Under the law, a third-party arbiter chooses between amounts offered by the payer and provider.
But providers claim that the Biden administration gravely misconstrues congressional intent in how the arbiter should choose which offer. They point to language in the rule that calls for the arbiter to primarily consider which amount is closest to the ‘qualifying payment amount’ that is the insurer’s median in-network rate for a specific region.”

Centene to pay Kansas $27.6M to settle drug overbilling allegations: “Centene reached a $27.6 million agreement with Kansas to settle allegations it overcharged the state for drugs, Kansas Attorney General Derek Schmidt said Dec. 6 in a news release.
Kansas began its investigation into Centene in 2019, after a similar effort in Ohio revealed pharmacy benefit managers were overbilling states. Kansas' investigation concluded that Centene artificially inflated dispensing fee amounts reported to state regulators and failed to report discounts it received from CVS-Caremark on certain retail pharmacy claims.”

CVS Health Contributes $9.2M to Address SDOH, Homelessness in DC: “The payer’s contributions will go toward building a 41-unit housing development in DC that aims to reduce homelessness and increase access to affordable housing.”

Underinsurance Among Children in the United States: “From 2016 to 2019, the proportion of US children experiencing underinsurance rose from 30.6% to 34.0% (+3.4%; 95% CI, +1.9% to +4.9%), an additional 2.4 million children. This trend was driven by rising insurance inadequacy (24.8% to 27.9% [+3.1%; 95% CI, +1.7% to +4.5%]), which was mainly experienced as unreasonable out-of-pocket medical expenses. Although the estimate of children lacking continuous insurance coverage rose from 8.1% to 8.7% (+0.6%), it was not significant at the 95% CI (−0.5% to +1.7%). We observed significant growth in underinsurance among White and multiracial children, children living in households with income ≥200% of the federal poverty limit, and those with private health insurance. Increased child health complexity and private insurance were significantly associated with experiencing underinsurance (adjusted odds ratio, 1.9 and 3.5, respectively).”

About Covid-19

Real-time alerting system for COVID-19 and other stress events using wearable data: “…analysis of smartwatch signals by an online detection algorithm provides advance warning of SARS-CoV-2 infection in a high percentage of cases. This study shows that a real-time alerting system can be used for early detection of infection and other stressors and employed on an open-source platform that is scalable to millions of users.”

Rise in Blood Pressure Observed Among US Adults During the COVID-19 Pandemic: “… annual BP increase was significantly higher in April to December 2020 than 2019 (P<0.0001 for systolic and diastolic BP). During the pandemic period, mean changes each month, compared with the previous year, ranged from 1.10 to 2.50 mmHg for systolic BP and 0.14 to 0.53 mmHg for diastolic BP; systolic and diastolic BP increases held true for men and women and across age groups; larger increases were seen in women for both systolic and diastolic BP, in older participants for systolic BP, and in younger participants for diastolic BP (all P<0.0001)…
Weight gain was not the apparent reason for the observed rise in BP during the pandemic…”

Gen Z most stressed by coronavirus, citing pandemic toll on careers, education and relationships, poll says: “Higher proportions of Americans between ages 13 and 24 say the pandemic has made their education, career goals and social lives more difficult, compared with millennials and Gen X.”

About pharma

Biden points to drug prices in call for Senate social spending vote: “Lowering drug prices is one of the most popular parts of Biden's sweeping climate and social spending measure, and Democrats are looking to tout the changes and hammer Republicans for opposing them. A Kaiser Family Foundation poll found that 83 percent of the public supports allowing the government to lower drug prices.”

The unraveling of Walgreens Boots Alliance: “Walgreens Boots Alliance is reportedly exploring the sale of its Boots pharmacy so that the Deerfield-based company can focus on plans to transform its U.S. stores into health care destinations…
Sky News, which first reported the potential deal, said the company could also spin off the chain into a separately listed company.
Analysts agree that offloading Boots makes sense for Walgreens. The company already sold the majority of distributor Alliance Healthcare to AmerisourceBergen earlier this year for $6.5 billion, including cash and stock.”

About hospitals and health systems

Nearly All States Have At Least 70% Of Hospital And ICU Beds Occupied: “Nearly all U.S. states have at least 70% of their hospital and intensive care unit beds occupied and could face hospital constraints if coronavirus cases continue to surge amid the spread of the delta variant and new omicron variant.
There are 611,917 (78.7%) hospital beds and 65,226 (79.3.%) intensive care units occupied in the U.S., with Covid-19 patients occupying 59,579 (7.75%) of hospital beds and 13,736 (17.53%) of ICU beds, according to the Department of Health and Human Services.”

Top Hospitals: From the Leapfrog Group. Note the absence of some of the top rated hospitals, e.g., Cleveland and Mayo Clinics, Children’s Hospital of Pennsylvania, etc.

Supreme Court won't hear antitrust suit against Atrium Health: “The justices won't review a March decision from the U.S. Court of Appeals for the 4th Circuit, which rejected a proposed class-action lawsuit that argued Atrium exploited its market dominance to prohibit insurers from directing patients toward lower-cost care options.”

About healthcare IT

Medicare Beneficiaries’ Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location: From CMS:
”KEY POINTS

• The number of Medicare fee-for-service (FFS) beneficiary telehealth visits increased 63-fold in 2020, from approximately 840,000 in 2019 to nearly 52.7 million in 2020.

• Despite the increase in telehealth visits during the pandemic, total utilization of all Medicare FFS Part B clinician visits declined about 11% in 2020 compared to levels in 2019.

• Most beneficiaries (92%) received telehealth visits from their homes, which was not permissible in Medicare prior to the pandemic.

• Prior to the pandemic, telehealth made up less than 1% of visits across all visit specialties but increased substantially in 2020. Telehealth increased to 8% of primary care visits, while specialty care had smallest shift towards telehealth (3% of specialist visits).

• Visits to behavioral health specialists showed the largest increase in telehealth in 2020. Telehealth comprised a third of total visits to behavioral health specialists. While data limitations preclude clear identification of audio-only telehealth services, up to 70% of these telehealth visits during 2020 were potentially reimbursable for audio-only services.

• Black and rural beneficiaries had lower use of telehealth compared with White and urban beneficiaries, respectively. Telehealth use varied by state, with higher use in the Northeast and West, and lower in the Midwest and South.”

Ascension, Johns Hopkins & 14 others launch campaign to protect telehealth access: “Sixteen leading healthcare organizations have partnered to launch Telehealth Access for America, a public education campaign to defend telehealth access.
The campaign, launched Dec. 2, is urging Congress to protect access to telehealth, arguing such services lead to better health outcomes, greater equity, more patient choice and lower costs.
The 16 members are: Adventist Health Policy Association, Alliance for Connected Care, AARP, American Heart Association, American Hospital Association, American Telemedicine Association, Ascension, Athenahealth, Consumer Technology Association, Executives for Health Innovation, Health Innovation Alliance, Healthcare Leadership Council, Included Health, Johns Hopkins Medicine, Partnership to Advance Virtual Care, and Teladoc Health.”
In a related article: Top 25 telehealth hospitals ranked by visit claims: “University of Michigan Hospitals and Health Centers in Ann Arbor topped the list of hospitals providing the most telehealth visits billed to Medicare during the first quarter of 2021, according to a Dec. 6 analysis from Hospital Pricing Specialists.”

About health care professionals

Female Physicians Earn An Estimated $2 Million Less Than Male Physicians Over A Simulated 40-Year Career: “Differences in income between male and female academic physicians are well known, but differences for community physicians and career differences in income have not been quantified. We used earnings data from 80,342 full-time US physicians to estimate career differences in income between men and women. The differences in annual income between male and female physicians that we observed in our simulations increased most rapidly during the initial years of practice. Over the course of a simulated forty-year career, male physicians earned an average adjusted gross income of $8,307,327 compared with an average of $6,263,446 for female physicians—an absolute adjusted difference of $2,043,881 and relative difference of 24.6 percent. Gender differences in career earnings were largest for surgical specialists ($2.5 million difference), followed by nonsurgical specialists ($1.6 million difference) and primary care physicians ($0.9 million difference). These findings imply that over the course of a career, female US physicians were estimated to earn, on average, more than $2 million less than male US physicians after adjustment for factors that may otherwise explain observed differences in income, such as hours worked, clinical revenue, practice type, and specialty.”

Today's News and Commentary

About Covid-19

Omicron may be less severe than delta, early reports suggest: “New data from South Africa suggests the omicron COVID-19 variant may cause less severe infections than delta, though more research is needed to confirm this finding.”

CMS suspends enforcement of COVID-19 vaccination mandate: “CMS has suspended implementation and enforcement of its COVID-19 vaccination mandate for healthcare workers pending developments in litigation, the agency said in a Dec. 2 memorandum.”

FDA authorizes Lilly antibody treatment for use in children, including newborns: “The treatment is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together through intravenous infusion. It was previously authorized for pediatric patients 12 years of age and older weighing at least 88 pounds.
The treatment is now authorized for all pediatric patients who have a positive COVID-19 test or who have been exposed to someone with COVID-19, who are at high risk for progression to severe COVID-19, including hospitalization or death. 

The US is averaging more than 100,000 new Covid-19 cases a day, the highest level in two months: “For the first time in two months, the US is averaging more than 100,000 new Covid-19 cases each day, shortly after millions of Americans traveled for the Thanksgiving holiday. 
The seven-day moving average of new cases was 121,437 as of Saturday, according to data from Johns Hopkins University (JHU). Prior to this week, the US last topped the 100,000-cases-a-day mark in early October.
Also on the rise is the number of Covid-19 deaths, with a seven-day average of 1,651 people dying from the virus each day as of Saturday, the JHU data showed. Average daily deaths haven't been this high in more than a month.”

Coronavirus vaccine demand grows in U.S. amid omicron variant concerns, booster eligibility expansion: “Health-care providers administered 2.18 million doses of coronavirus vaccines on Thursday, according to the Centers for Disease Control and Prevention — the ‘highest single-day total since May,’ the White House said. According to the latest CDC report, over the week ending on Thursday, the average number of daily administered vaccine doses reported to the agency was 22 percent higher than the previous week…
The increased demand for coronavirus vaccines is largely driven by demand for booster doses, CDC data shows.”

It Would Cost $50 Billion to Vaccinate the World, OECD Says: “That’s the amount needed to vaccinate the world, a measure that’s key to ending the pandemic and tackling the imbalances ‘plaguing the recovery,’ according to OECD Chief Economist Laurence Boone. 
‘When you balance things out, $10 trillion for supporting the economy going through the pandemic compared with a tiny $50 billion to bring the vaccine to the entire world population, that looks completely disproportionate,’ she told Bloomberg Television in an interview Wednesday. The first number is the amount spent by Group of 20 countries to mitigating the economic impact of Covid-19.”

New York City Announces Vaccine Mandate for Private Employers: “Mr. de Blasio said the aggressive measure, which takes effect Dec. 27 and which he described as the first of its kind in the nation, was needed as a ‘pre-emptive strike’ to stall another wave of coronavirus cases and help reduce transmission during the winter months and holiday gatherings.”

Novavax to Develop Omicron-Specific COVID-19 Shot: “Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus….
The current vaccine (known as Covavax outside the U.S.), which is yet to be authorized in the U.S…”

U.S. to not reimburse private health insurers for covering at-home COVID test costs: “‘The Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act require coverage of diagnostic testing for COVID-19 without any cost-sharing requirements during the public health emergency,’ the White House official said.
’The Departments of Health and Human Services, Labor and the Treasury will clarify that coverage of over-the-counter COVID-19 tests is generally subject to those provisions,’ the official added.”

Pfizer accused of funding anti-AstraZeneca information: “US drugmaker Pfizer, the world’s dominant Covid vaccine maker, has been accused of funding educational presentations that said its UK rival AstraZeneca was ineffective and even dangerous for some members of the population.”

About pharma

Express Scripts launches new prescription discount card solution: “Through the new Right Price offering, a member who is eligible for savings through a discount card will automatically see those savings applied at the pharmacy counter. Matt Perlberg, senior vice president of supply chain at Express Scripts, told Fierce Healthcare that the pharmacy benefit manager most often sees these discounts come into play for members who have yet to meet their deductible.
For about 2% of claims, members who are purchasing generic drugs but have not yet met the deductible may find these coupon cards lead to a lower price than their drug benefits, Perlberg said.”

Drug prices slashed over 60% on average to get on China's bulk-buying list: What happens when a country uses its purchasing power to buy pharmaceuticals?
“Chinese authorities said Friday that the National Reimbursement Drug List (NRDL) has been updated, with pharmaceutical firms agreeing to cut prices by an average of 62% for 67 branded medicines that have no generic equivalents in the country. Meanwhile, seven drugs that do have generic versions were also included, for a total of 74 additions to the centralised procurement scheme this time around, while 11 medicines of low clinical value were removed, according to the National Healthcare Security Administration (NHSA).
The latest average discount marks a record for the bulk-buying programme, which negotiated average cuts of 61% for 70 drugs in 2019, and of 51% on 119 drugs in 2020. For the 2021 edition, new listings include Eli Lilly's psoriasis treatment Taltz (ixekizumab) and Johnson & Johnson's multiple myeloma drug Darzalex (daratumumab), the latter of which saw its annual cost reduced from CNY1 million ($157,000) to under CNY300,000 ($47,000) per year under the scheme.”

Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers:
“KEY FINDINGS:

• Overall, gross profit (defined as revenue minus the cost of goods sold) increased by 12%, from $25 billion in 2017 to $28 billion in 2019.

• Between 2017 and 2019, PBMs adapted their business model to rely more on revenue collected through fees assessed on manufacturers and payers and gross profit on prescriptions filled through affiliated mail order and specialty pharmacies, while shifting away from a dependence on retained rebates.”

An important caveat to the above research: “It is notable that available financial data proved insufficient to fully describe the source of nearly 40% of PBMs’ total gross profit. Exploration of all publicly available data, an extensive review of the literature and our survey of industry insiders cast little light
onto specific gross profit derived from a variety of PBM business practices that include, but may not
be limited to, spread pricing, pharmacy fees and clawbacks, fees collected from payers, and other non-administrative fees collected from manufacturers.” [Emphasis in the original.]

BD finalizes name and leadership for its billion-dollar diabetes spinoff: “BD has settled on a new name for its new company, the independent spinout that will house its billion-dollar diabetes care business. 
Embecta is set to launch as its own, publicly traded brand in the second quarter of 2022 after almost a century of supplying a portfolio of insulin pens and syringes under the BD banner. The diabetes division contributed about 6% of the company’s revenues in the 2020 fiscal year, or nearly $1.1 billion, by serving about 30 million users worldwide.”

About the public’s health

Immune system-stimulating nanoparticle could lead to more powerful vaccines: “Researchers from MIT, the La Jolla Institute for Immunology, and other institutions have now designed a new nanoparticle adjuvant that may be more potent than others now in use. Studies in mice showed that it significantly improved antibody production following vaccination against HIV, diphtheria, and influenza…
The researchers now hope to incorporate the adjuvant into an HIV vaccine that is currently being tested in clinical trials, in hopes of improving its performance.”

Association of Prenatal Care Services, Maternal Morbidity, and Perinatal Mortality With the Advanced Maternal Age Cutoff of 35 Years: “In this cross-sectional study, the AMA [advanced maternal age] designation at age 35 years was associated with an increase in receipt of prenatal monitoring and a small decrease in perinatal mortality, suggesting that the AMA designation may be associated with clinical decision-making, with individuals just older than 35 years receiving more prenatal monitoring. These results suggest that increases in prenatal care services stemming from the AMA designation may have important benefits for fetal and infant survival for patients in this age range.”

About health insurance

CMS Provides Guidance on Good Faith Estimates for No Surprises Act: “CMS has released 11 documents to help providers comply with the No Surprises Act’s requirement that providers give patients a ‘good faith estimate’ of expected charges.
The No Surprises Act was passed as part of the Consolidated Appropriations Act, 2021. The Act will prohibit surprise medical billing in most healthcare situations starting Jan. 1, 2022. As part of No Surprises Act compliance, providers and facilities will need to be able to inform patients, both orally and in writing, of a cost estimate if they are not enrolled in a plan or are covered by a federal healthcare program, or who are not seeking to file a claim with their insurance for care. This ‘good faith estimate,’ as the Act calls it, must be given upon request or at the time of scheduling.
Included in the documents released by CMS is a template for providers and healthcare facilities to use to deliver good faith estimates under the No Surprises Act.“

An Analysis of Medicare Accountable Care Organization Expense Reports: The objective of the study was to ” understand the investments that Medicare Shared Savings Program accountable care organizations (ACOs) in the ACO Investment Model (AIM) made to participate in the program and the costs that they incurred as a result of their efforts to lower spending and improve quality…
AIM ACOs reported expenses of $264.8 million over the 3 performance years (2016-2018). The majority of the $264.8 million in expenditures was incurred for personnel (55.5%), followed by infrastructure (22.3%), management firm expenses (15.3%), and internal programs and systems (6.9%). The dominant identifiable ACO strategy was care coordination and management, accounting for 52.9% of related ACO expenses…
Efforts to change clinician practice patterns, alter the way patients access the health care system, and institute other practice redesigns were not primary targets for investment.”

The Medicare Advantage Quality Bonus Program Has Not Improved Plan Quality: “In 2012 Medicare introduced the quality bonus program, linking financial bonuses to commercial insurers’ quality performance in Medicare Advantage (MA). Despite large investments in the program, evidence of its effectiveness is limited…
We observed no consistent differential improvement in quality for MA versus commercial enrollees under the quality bonus program. Program participation was associated with significant quality improvements among MA beneficiaries on four measures, significant declines on four other measures, and no significant change in overall quality performance (+0.6 percentage points). Together, these results suggest that the quality bonus program did not produce the intended improvement in overall quality performance of MA plans.”

About hospitals and health systems

Physician Compensation In Physician-Owned And Hospital-Owned Practices: “Among physician practices overall, vertical integration with hospitals or health systems was associated with, on average, 0.8 percent lower income compared with independent physicians after multivariable adjustment. In analyses by physician specialty, vertical integration of physician practices with hospitals or health systems was associated with lower income for nonsurgical specialists, no difference in income for primary care physicians, and slightly higher income for surgical specialists. Although vertical integration of physician practices is a rapidly growing trend, physicians might not directly benefit financially.”

Trinity Health's operating income doubles: “Trinity Health reported higher revenue and operating income in the three months ending Sept. 30 than in the same period a year earlier, according to financial documents released Dec. 3….
Trinity also reported higher expenses…
After factoring in investments and other nonoperating items totaling $164.87 million, Trinity posted a net income of $378.83 million in the first quarter of fiscal year 2022, down from $771.87 million a year earlier.”

Today's News and Commentary

About Covid-19

Early data shows past infection does not ward off Omicron, but vaccines effective: “People infected with earlier variants of COVID do not appear to be protected against Omicron, although vaccination does prevent serious illness, a top South African scientist said on Thursday.
‘We believe that previous infection does not provide protection from Omicron,’ said Anne von Gottberg, an expert at the National Institute for Communicable Diseases.
Outlining early research into the newly emerged variant, she said doctors were seeing ‘an increase for Omicron reinfections.’”

Immunogenicity of Extended mRNA SARS-CoV-2 Vaccine Dosing Intervals: “Longer mRNA vaccine dosing intervals demonstrated improved immunogenicity, which was consistent when responses were measured based on timing of the first or second dose. These data suggest that extending dosing intervals may be particularly advantageous against the Delta variant.”

FDA asks for 55 years to complete FOIA request on Pfizer's COVID-19 vaccine: “Hungry for details on Pfizer's COVID-19 vaccine? Just file a Freedom of Information Act (FOIA) request and wait until the U.S. tricentennial in 2076. That's the schedule the FDA proposed in documents filed in a U.S. District Court this week.
According to the documents filed in a U.S. District Court for the Northern District of Texas, the FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer-BioNTech's COVID-19 vaccine, Comirnaty.”

Biden seeks to require private health plans to pay for at-home Covid tests: “However, the requirement will not take effect immediately. Three federal departments — Health and Human Services, Labor and the Treasury — must still issue official guidance on the reimbursement requirement, language that may not be published until Jan. 15.
The forthcoming policy change will also not be retroactive, meaning people will not be able to obtain reimbursement for at-home tests they already purchased, the senior administration official said. It is also unclear if limitations will be placed on the number of at-home tests individuals can submit for reimbursement.”
Insurance companies are worried that such a policy will result in price gouging, which has occurred in the past. Eventually, such behavior will cause increased premiums- no such thing as a free lunch.

Biden pledges to fight new variant ‘with science and speed,’ as omicron cases multiply and winter outlook worsens: Reinforcing yesterday’s report on the summary of measures the federal government is proposing.
The article has videos of Biden and Fauci. “The president’s plan includes campaigns to increase vaccinations and booster shots, more stringent testing for international travelers and plans to make rapid at-home coronavirus testing free for more people. While some of the measures are new — notably a plan to launch ‘family mobile vaccination clinics,’ where all eligible members of a family could simultaneously get shots and boosters — others build on existing tactics, such as rallying businesses to impose vaccination-or-testing mandates for employees.”

Omicron COVID-19 variant found in five U.S. states: “New York has confirmed five cases of the Omicron coronavirus variant, its governor said on Thursday, bringing to five the number of U.S. states having detected the variant, with 10 reported infections nationwide.
California, Colorado and Minnesota have found cases of the coronavirus variant among patients who were fully vaccinated and developed mild symptoms, while Hawaii reported a case with an unvaccinated person, who had moderate symptoms.”

Walmart extends COVID leave policy, brings back vaccination incentives: “Walmart, the nation’s largest retailer, is responding to the threat of the new Omicron variant of COVID-19 by extending its COVID leave policy for associates through March 31, 2022, as well as reintroducing its vaccine incentive for frontline associates to provide $150 after an associate becomes fully vaccinated.
The COVID leave policy, which was implemented in March 2020 during the initial surge of the pandemic, provides up to two weeks of paid time off if an associate contracts COVID-19, if a facility is part of a mandated quarantine or if an associate is required to quarantine by a health care provider, government agency or Walmart.”

About pharma

In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs: From the Urban Institute:
”In this brief, we explore prescription drug affordability challenges using pooled 2018 and 2019 data from the Medical Expenditure Panel Survey. We primarily focus on the extent to which elderly adults ages 65 and older with Medicare and nonelderly adults ages 19 to 64 with year-round private insurance delay or forgo needed prescription drugs because of the cost and their out-of-pocket spending burdens. We find the following:

• Nearly 13 million adults delayed or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.

• About 1 in 10 adults who were uninsured all year (9.5 percent) or part of the year (11.6 percent) reported unmet prescription drug needs, compared with 4.9 percent of Medicare beneficiaries, 3.0 percent of privately insured adults, and 5.6 percent of adults with Medicaid.

• For both Medicare beneficiaries and privately insured adults, unmet prescription drug needs were most common among women, people with low incomes, and people with multiple chronic health conditions. Nearly all Medicare beneficiaries and more than 8 in 10 privately insured adults with unmet needs have been diagnosed with a chronic condition such as high blood pressure, high cholesterol, stroke, diabetes, arthritis, and respiratory illnesses.

• More than one-quarter of adults with Medicare (25.4 percent) and 5.3 percent of privately insured adults spent more than 1 percent of their family incomes on their individual out-of-pocket prescription drug costs. More than 3 percent of Medicare beneficiaries—and nearly 7 percent of beneficiaries with unmet prescription drug needs—spent more than 10 percent of their family incomes on prescription drugs.”

PCMA pulls lawsuit over rebate disclosure rule after reaching deal with Biden admin: “The Pharmaceutical Care Management Association (PCMA) pulled its lawsuit, filed back in August in the U.S. District Court for the District of Columbia, after having engaged with the Biden administration on a resolution. The administration issued a final rule last month that still required PBMs to disclose rebate prices to the federal government but won't be released publicly.
The lawsuit centered on a rule passed near the end of the Trump administration that required PBMs to publicly post the rebate amounts they negotiate with drugmakers.”

Sanofi to Progress 10 New Candidates in Vaccine Pipeline: “Six of those candidates will leverage the mRNA Center of Excellence that the company established in June, into which it pledged to pump $500 million a year…
A giant in the vaccine industry that hasn’t yet had success in the COVID-19 space, the company said sustained growth will be driven by its four core franchises: influenza, meningitis, PPH3 and boosters, as well as the planned launch of nirsevimab, a first-in-class monoclonal antibody for all infant protection against respiratory syncytial virus (RSV).

About the public’s health

Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial: “Financial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.”
The success of using financial incentives to motivate behavior is situationally dependent— which is why these specific studies need to be performed.

HHS seeks comment on efforts to improve organ transplant equity, dialysis care: “The U.S. Department of Health and Human Services, through the Centers for Medicare and Medicaid Services, is soliciting public feedback on potential changes to rulemaking it's considering to improve both the organ transplantation system and dialysis care -- part of a broader effort to introduce more equity into the healthcare system.
The formal Request for Information issued by the agency stems from a Biden Administration goal of improving health outcomes for the roughly 106,000 people who are living with organ failure and are awaiting a transplant.”

FDA approves trivalent hepatitis B vaccine for adults: “According to VBI Vaccines, PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens and is the only approved three-antigen HBV vaccine for adults…
The approval of PreHevbrio was based on the results of two phase 3 studies that compared the vaccine with a monovalent HBV vaccine. Adults aged 18 years and older who received PreHevbrio elicited higher rates of seroprotection (91.4% vs. 76.5%). This included adults aged 45 years and older (89.4% vs. 73.1%).
PreHevbrio is expected to be available in the U.S. in the first quarter of 2022, VBI Vaccines said.”

About healthcare IT

Assessment of Patient Preferences for Telehealth in Post–COVID-19 Pandemic Health Care: “In this survey study of 2080 adults, most respondents were willing to use video visits in the future but, when presented with the choice between an in-person or a video visit for nonemergency care, most preferred in-person care. Willingness to pay for preferred visit modality was higher for those who preferred in-person care, and those who preferred video visits were more sensitive to out-of-pocket cost.”

Google rolls out new search tools for health information on Medicare services, languages spoken by providers: “Announced Thursday in a blog post by Hema Budaraju, director of Google Search's social impact division, the additions make it easier for patients to seek out doctors near them that fulfill their individual needs, addressing questions like whether a provider accepts Medicare or what languages that provider speaks.”

The Digital Experience is the Key Driver of Growth and Patient Retention, According to Press Ganey’s 2021 Consumer Report: From a Press Ganey survey:

• “All generations are increasingly shopping online for healthcare. 44% of baby boomers and 60% of millennials and Gen Z prefer researching healthcare providers on their smartphone or tablet, representing a 27% and 13% increase from 2019, respectively.

• Digital drives patient choice. In fact, they rely on digital resources more than twice as much as provider referrals when choosing a healthcare provider. [Emphasis added]On average, consumers use three different websites during their healthcare research process and five reviews before making a decision.

• Search engines are just the start. Among the top five websites used, consumers rely on a brand’s website, WebMD, Healthgrades and Facebook the most to research a provider.

• Online reviews prevent referral leakage. 83% of patients go online to read reviews about a provider after they receive a referral. 84% would not see their referred provider if they had less than a four-star rating.

• Customer service is the new bedside manner. Assuming quality care is received, patients rate “customer service” (71%) and “communication” (64%) as more important than even “bedside manner” when it comes to rating a five-star experience.

• Telehealth isn’t going anywhere anytime soon. More than one-third of patients have used telehealth in the past year—a 38% increase since 2019—and usage surged among baby boomers during the same period.

About health insurance

Providers slam House for not delaying nearly 10% Medicare payment cuts in must-pass spending deal: “Major provider groups were livid that a continuing resolution to fund the federal government also doesn’t stave off nearly 10% in cuts to Medicare payments set to go into effect on Jan. 1.
The Federation of American Hospitals and American Medical Association were upset that legislative language to fund the government through Feb. 18 does not delay cuts from several sources including the Sequester and PAYGO law. Other providers have been lobbying Congress fervently on the cuts.”

Unum: Workers to pay more attention during open enrollment this year:

• “Two-thirds of workers surveyed by employee benefits provider Unum said they plan to pay more attention and spend more time reviewing their choices during open enrollment this year. Unum polled 1,500 full-time U.S. workers in August.

• Fifty-seven percent of respondents said they will enroll in benefits they did not have last year. The uptick may be due to greater awareness; two-thirds of workers said they are more interested or aware of the choices their employers provide.

• Concern over finances and mental health will drive workers' choices, Unum's findings indicated.”

About hospitals and health systems

State-by-state breakdown of 73 hospital closures: About 60 million people — nearly 1 in 5 Americans — live in rural areas and depend on their local hospitals for care. More than 70 of those hospitals have ended all services since 2011, according to the Cecil G. Sheps Center for Health Services Research.”

Texas hospital will pay $18.2M to settle false claims case: “The settlement resolves allegations that Flower Mound Hospital, a partially physician-owned facility, violated the Anti-Kickback Statute and Stark Law when it repurchased shares from physician-owners aged 63 or older and then resold those shares to younger physicians. Prosecutors allege that hospital leaders took into account the volume or value of physicians' referrals when selecting which physicians to resell the shares to and determining the number of shares each physician would receive.”

About medical devices

Device Recalls Soar in Recent Months: “Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests.” See this FDA website for specific products.

Today's News and Commentary

About Covid-19

Survey: Many employers rolling out vaccine mandates despite ongoing legal challenges: “Willis Towers Watson surveyed nearly 550 employers in mid-November and found that 57% either currently require workers to be vaccinated or are planning to roll out such requirements. Eighteen percent of those surveyed currently require employees to be vaccinated against COVID-19.
In addition, 32% said they were planning to roll out requirements if the Occupational Safety and Health Administration (OSHA) emergency standard takes effect. The remaining 7% said they plan to require vaccinations regardless of what happens to the OSHA standard.”

Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older: “In this nationwide study involving persons aged 75 years or older in France, no increase in the incidence of acute myocardial infarction, stroke, and pulmonary embolism was detected 14 days following each BNT162b2 mRNA vaccine dose.”

The White House's plan to combat winter COVID-19 surges: 8 things to know: A good summary of the recent federal activities geared to pandemic control.

Moderna loses appeal in standoff over Arbutus vaccine patents: “Moderna could face a patent infringement lawsuit over its COVID-19 vaccine Spikevax after the US Court of Appeals for the Federal Circuit on Wednesday affirmed decisions by an administrative panel regarding patents that belong to Arbutus Biopharma. Specifically, the federal appeals court let stand findings by the Patent Trial and Appeals Board (PTAB) regarding two Arbutus patents dealing with liquid nanoparticle (LNP) technology, which can be used to deliver mRNA to cells.
The news sent Moderna stock sliding 9%, while shares in Arbutus jumped as much as 57%. The latter company was ‘heavily favoured’ to win the appeals, according to Jefferies analysts Kelechi Chikere and Michael Yee. In court filings, Moderna has indicated that Arbutus could bring a lawsuit demanding royalties from its COVID-19 vaccine if the patents are upheld. The company is expecting that Spikevax will generate a total of between $15 billion and $18 billion in 2021, and up to $22 billion next year.”

5 health systems suspending vaccination mandates: Includes Intermountain and HCA.

COVID-19 Still Widely Named as Biggest U.S. Health Problem: “In a Gallup poll conducted Nov. 1-16, 47% of U.S. adults named viruses as the country's top health problem, with the vast majority of these (45%) mentioning COVID-19 or the coronavirus, specifically. In November 2020, 69% saw viruses as the top threat, including 67% citing COVID-19.” Access was named by 11%. Quality was not mentioned.

GSK says early data suggest its Covid drug is effective against Omicron: “The UK drugmaker and its partner, Vir Biotechnology, said on Thursday that initial tests suggested their antibody treatment, called sotrovimab, was effective against Omicron’s mutations. The research has not been peer-reviewed and lab tests of sotrovimab are still to be completed but the UK health regulator on Thursday approved its use for high-risk patients. The companies said they would provide updated data by the end of this year.”

About pharma

CVS expands 'talking' prescription labels to all locations to support visually impaired patients: “CVS Pharmacy is expanding an in-app feature for visually impaired patients, which reads prescription information out loud, to all of its nearly 10,000 U.S. locations.
The solution, called Spoken Rx, was designed in collaboration with the American Council of the Blind. Patients enrolled in the program can scan the labels on their prescription containers and have their information, including the medication’s name and directions for use, read out loud to them in either English or Spanish.”

About healthcare IT

HHS launches website for healthcare cybersecurity resources: “HHS unveiled a website Dec. 1 for its 405(d) Aligning Health Care Industry Security Approaches Program that offers healthcare providers and public health officials cybersecurity and patient safety resources and best practices. 
The 405(d) program was established as a congressional mandate under the Cybersecurity Act of 2015; under section 405(d), HHS created the Cybersecurity Act Task Group to strengthen cybersecurity efforts within the healthcare and public health sectors.”

VA revises timeline for $16B Cerner EHR rollout, taps new project leaders: “The Department of Veterans Affairs is planning to pick up deployment of its $16 billion Cerner EHR system in early 2022 after the project was paused earlier this year because of inadequate training and safety concerns.”

Assessment of Patient Preferences for Telehealth in Post–COVID-19 Pandemic Health Care: “This survey study found that participants were generally willing to use video visits but preferred in-person care, and those who preferred video visits were more sensitive to paying out-of-pocket cost. These results suggest that understanding patient preferences will help identify telehealth’s role in future health care delivery.”

TransUnion acquires IT services company for $3.1B: “TransUnion finalized its acquisition of information services and tech company Neustar for $3.1 billion, the credit reporting agency said Dec. 1”

Telehealth take-up: the risks and opportunities: In this Kaspersky survey:
“Half (52%) of remote telehealth providers have experienced cases where patients, not trusting the technology, have refused to have a video call with staff – citing concerns about privacy and data safety. Clinicians have also voiced their own reservations, with eight in ten (81%) raising concerns over conducting remote telehealth sessions. These include concerns about how patient data will be used and shared from these sessions, as well as the security of data and any personal penalties that might arise in the case of a leakage from a remote consultation…
Worryingly, three in ten (34%) remote telehealth providers agree that one or more clinicians in their organization have made a wrong diagnosis because of poor video or photo quality.
When it comes to the safety afforded by operating system upgrades, seven in ten (73%) healthcare providers currently use medical equipment with a legacy OS. Reasons for this include the cost of upgrades being too high (37%), compatibility issues (29%), not having the internal knowledge on how to upgrade (17%), and other reasons (18%).”

About the public’s health

Rhythm Biosciences Gets CE Mark for Colorectal Cancer Test: “The immunoassay measures the presence of multiple protein biomarkers for colorectal cancer that were identified by Australia's Commonwealth Scientific and Industrial Research Organization.
Rhythm Biosciences says the simple blood test ‘has the potential to become the new first-step screening test’ for people who choose not to participate in the existing screening programs for colorectal cancer.”

Mumps in Vaccinated Children and Adolescents: 2007–2019: “Since 2007, one-third of US reported mumps cases occurred in children and adolescents, the majority of whom were vaccinated. Clinicians should suspect mumps in patients with parotitis or mumps complications, regardless of age, travel history, and vaccination status.”

HPV Vaccine Is Reducing Cervical Cancers in Teens, Young Women: “Since the vaccine went on the market, cervical cancer deaths have declined by 43% and cases by 38% in females between 15 and 24 years of age, researchers found.
By comparison, cervical cancer deaths actually increased on average about 4% in women between 25 and 29 and declined by about 5% in women in their 30s.
Cases fell by 16% for those between 25 and 29 and by 8% for those in their 30s.”

What abortion laws would look like if Roe v. Wade were overturned: An excellent overview of the headline’s subject.

About health insurance

Democrats’ Bill Would Go Far Toward ‘Patching the Holes’ in Health Coverage: A really good summary of the proposal by three of The NY Times’ top health reporters.

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 Virulence, a 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-analysis: “In 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 Efficiency: From the Lown Insitute. See this site for a ranked list and search engine.

About healthcare IT

8 reasons patients are resistant to telehealth: “During 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 2021: The 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.