Today's News and Commentary

March 28, 2023 Joel Shalowitz

About Covid-19

U.S. court upholds block on Biden's vaccine order for federal workers “A federal appeals court in New Orleans on Thursday upheld a judge's ruling blocking enforcement of President Joe Biden's 2021 executive order requiring all federal employees take a COVID-19 vaccine.”

About health insurance/insurers

Reducing Medicare Advantage Benchmarks Will Decrease Plan Generosity, But Those Effects Will Likely Be Modest “We assessed the relationships between MA benchmarks and plan generosity and benefits. We estimated that a $1,000 per year decrease in benchmarks would lead to small increases in annual premiums of about $60 and increases in annual deductibles of about $27. Copays would also increase modestly, and the propensity to offer benefits would generally decline by less than 5 percentage points, with the greatest impact being on the availability of dental, hearing, and vision benefits. These results suggest that although cuts to MA benchmarks would adversely affect plan generosity, those effects would be modest.”

UPMC for You partners to offer Medicaid redetermination coverage in laundromats “Ahead of Medicaid redeterminations on April 1, UPMC's Medicaid managed care plan has announced a partnership with Fabric Health to provide on-site health support and social services access in certain laundromats.
The initiative with UPMC's Medicaid plan UPMC for You, will provide WiFi access as Fabric Health staff in laundromats help individuals navigate access to preventative and other healthcare coverage, apply for assistance programs, including Medicaid, SNAP and LIHEAP, and connect with other support services, UPMC said.
With over 32 million Americans using a laundromat each week, these businesses provide opportunities to connect with individuals who may need support, according to Fabric Health, that provides engagement in laundromats.”
Comment: The outreaches to such organizations as churches and barber shops are well-know. However, this program is very creative and, to my knowledge, unique. Are there other commonly used site that could be useful?

CVS set to close $8B deal for health services company Signify Health FYI

How Cigna Saves Millions by Having Its Doctors Reject Claims Without Reading Them An exposé by ProPublica well-worth reading. This essence of the article is: Cigna “has built a system that allows its doctors to instantly reject a claim on medical grounds without opening the patient file, leaving people with unexpected bills, according to corporate documents and interviews with former Cigna officials. Over a period of two months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the documents show.”

9 in 10 employers plan to change health and wellbeing vendors in next two years, WTW survey finds
“…the survey of 232 U.S. employers found nearly nine in 10 respondents (88%) are planning to make changes to their vendor partnerships either this year or next. Such changes include adding, enhancing or ending various solutions and services, or working with a different vendor in the foreseeable future.”
Comment: More details about types of vendors are in the article. While these these turnover numbers are extraordinarily high, the reasons for these changes are not clear. The article hints a link to ROI, which means companies are not finding these programs cost-effective, or even effective.

TWO OUT OF THREE PATIENTS HAVE NEVER DISPUTED A MEDICAL BILL “Almost two-thirds of respondents (64%) said they have never disputed the accuracy or validity of a bill, which was the case for 78% of uninsured individuals.
While 78% of respondents reported getting charges reduced or removed when they did contest a bill, it sometimes took more than six months for it to be resolved.”
Comment: One reasons patients do not challenge bills is that they do not understand them. Also, with the increased use of EMRs, copy and paste notes often do not accurately reflect the visit—leading to incorrect billing.

About healthcare quality

Consultation With Reduction in Adverse Postoperative Outcomes and Use of Processes of Care Among Residents of Ontario, Canada “In this cohort study, preoperative medical consultation was not associated with a reduction but rather with an increase in adverse postoperative outcomes, suggesting a need for further refinement of target populations, processes, and interventions related to preoperative medical consultation. These findings highlight the need for further research and suggest that referral for preoperative medical consultation and subsequent testing should be carefully guided by individual-level consideration of risks and benefits.”
Comment: As an accompanying editorial states: “Given the potential risks of preoperative evaluation, follow-up testing, procedures, and treatment, as well as its role in delaying needed surgeries, randomized clinical trials are urgently needed to document the risks and benefits of this common process.”

About hospitals and healthcare systems

MARCH 2023 National Hospital Flash Report “Key Takeaways:

A new normal continues to emerge.
Hospital margins in February were down slightly from the previous month. This represents the eighth straight month in which the variation in month-to-month margins has decreased relative to the last three years. Due to external economic factors, relatively flat margins are likely to continue in the near term.
Volumes stay relatively steady.
Due to the shorter month, discharges, patient days, and ED visits were all down slightly in February compared to January. On a per-day basis, however, hospitals experienced moderate growth in volumes in February. Average length of stay in the hospital was down, and patients continued to shift to ambulatory settings, with ambulatory surgery centers and outpatient operating rooms minutes seeing volume increases last month.
Outpatient settings drive revenue.
The onset of the COVID-19 pandemic kickstarted a shift in patient behavior that continues today. Patients continue to seek more of their care away from inpatient settings. This is illustrated in outpatient revenues continuing to grow in early 2023.
Costs of goods and services are increasing faster than labor.
Hospitals continue to face labor shortages. Labor expenses, however, appear to be holding steady indicating less dependence on contract labor. Meanwhile, inflation and pricing pressures are leading to significant cost increases in goods and services. This represents a change in what is driving hospital expenses from labor to the costs of goods and services.”

What’s Behind Losses At Large Nonprofit Health Systems? “We collected the most recent quarterly financial statements from 10 nonprofit hospital systems: Advent, Ascension, Advocate Aurora, CommonSpirit, Mass General Brigham, Sutter, Trinity, UPMC, Northwell, and Providence. Financial statements were downloaded from each hospital system’s website. These systems were selected due to their size and the public availability of their financial reports. While this did not constitute a statistically representative sample, it did provide insight into the financial profiles of some of the nation’s largest systems and the most important factors behind those profiles.
All 10 hospital systems reported negative overall profit margins (net income divided by revenue). Average overall profit margin fell from 9 percent in 2021 to -6 percent in 2022.
Large nonprofit health systems are reporting financial strain, even as the worst of the pandemic has passed. This financial strain is driven primarily by investment losses. [Emphasis added] Stock markets struggled in 2022, with the S&P 500 declining in value by approximately 20 percent. Hospital systems that invest heavily in stock markets, like many large nonprofit organizations, may be particularly exposed to these financial headwinds. Hospital systems that also invest in private equity funds, such as Ascension, are also subject to the financial risks of their specific funds.”

About pharma

Genomadix Genetic Test for Potential Drug Effectiveness Cleared “Genomadix has received FDA clearance for its Cube CYP2C19 test for assessing the potential effectiveness of drugs metabolized by the CYP450 2C19 genetic pathway.
The polymerase chain reaction test, which determines the presence of several gene mutations from swab taken from inside the mouth, delivers results in about an hour.”
Comment: This metabolism pathway for many drugs can guide dosing of some medications. The question is: Is it necessary and cost-effective. Past research on Coumadin (warfarin) showed that testing for CYP450 did not add to efficacy or reduce side effects.

Top 10 pharma R&D budgets in 2022 FYI

About the public’s health

Minnesota suit against e-cigarette maker Juul goes to trial “Minnesota Attorney General Keith Ellison is slated to lead off opening statements expected for Tuesday in his state’s lawsuit against Juul Labs – marking the first time any of the thousands of cases against the e-cigarette maker over its alleged marketing to young people is going to play out in a courtroom.”

US FDA seeks to allow salt substitutes in everyday foods “The U.S. Food and Drug Administration (FDA) on Friday said it was proposing a rule to allow the use of salt substitutes in everyday foods including cheese, frozen peas and canned tuna, in a bid to cut Americans' salt consumption.”

About healthcare IT

FDA outlines plan for digital health technologies for clinical trials “The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.
As part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA VII), the agency published a framework on 23 March on how it plans to address long-standing questions on the use of DHTs in drug clinical trials.”

Digital Access Coordinator Program Pilot Site Launches at Mass General “Mass General Brigham has launched a Digital Access Coordinator (DAC) Program pilot site at Mass General – a United Against Racism initiative to address gaps in digital literacy and increase patient access to tools, including Patient Gateway and virtual visits.”
Comment: While this announcement was published last June, I just found it and thought it was a very creative solution.

FBI Internet Crime Report 2022 Well worth scanning, particularly because among infrastructure sectors victimized by ransomware, healthcare is far and away the most frequently affected (see page 14).
Also, see page 18—losses are directly correlated to age.

About healthcare personnel

Healthcare employment rebounds to pre-pandemic levels “Contrary to widespread reports of staffing shortages, healthcare employment reached pre-pandemic levels with the addition of 44,200 jobs in February, according to a recent report from Altarum.”

About health technology

Combining Acoustic Bioprinting with AI-Assisted Raman Spectroscopy for High-Throughput Identification of Bacteria in Blood Don’t let the title dissuade you from scanning this article. This technology allows rapid identification of pathogens- which can guide early treatment.

Today's News and Commentary

March 21, 2023 Joel Shalowitz

About Covid-19

Moderna expects to price its COVID vaccine at about $130 in the US “Moderna previously said it was considering pricing its COVID vaccine in a range of $110 to $130 per dose in the United States, similar to the range Pfizer Inc said in October it was considering for its rival COVID shots sold in partnership with BioNTech.”

COVID-19 Deaths in U.S. Drop to Near Pandemic Low “The week ending in March 15 saw 1,706 coronavirus deaths – the lowest number reported since March 25, 2020, shortly after the World Health Organization first called the coronavirus a pandemic. That week, which was only the second week of the pandemic that the CDC tracker offered death numbers, saw 1,119 deaths.
Coronavirus cases and hospitalizations are also on the decline. Weekly infections are the lowest reported since the summer of 2021, but experts caution that the data is a drastic undercount as many rely on at-home testing that doesn’t get reported to health departments.”

About health insurance/insurers

DOJ Quietly Abandons UnitedHealth Merger Appeal “ The U. S. Department of Justice on Monday gave up on getting the D. C. Circuit to revive its challenge to UnitedHealth Group Inc. 's $13. 8 billion purchase of Change Healthcare Inc. , summarily dropping the case after four months of docket silence and six months after a D. C. federal judge rejected the lawsuit….”

Physician, pharmacist sentenced for a $515M pain cream scheme “A physician and pharmacist were sentenced in a pain cream scheme that cost healthcare benefit providers more than $515 million in Mississippi, Clarion Ledger March 10.
Gregory Auzenne, MD, entered a guilty plea for a misdemeanor charge of fraudulent failure to disclose information involving a federal healthcare program. He admitted to not notifying authorities of questionable activity done by former pharmacist Marco Moran.
Mr. Moran was sentenced to 10 years in prison for his involvement in the healthcare fraud.
Dr. Auzenne was sentenced to five years of probation and ordered to pay a $20,000 fine and about $116,623 in restitution.”

About hospitals and healthcare systems

Banner Health reports $16.6M operating income as labor costs decline The specific system is not as important as the news that labor costs are declining. Recall that, in the past year or so, labor and supply costs have been largely responsible for hospital losses.

Research: What Happens When Private Equity [PE] Firms Buy Hospitals? This HBR article is a really good review of the topic, discussing financial as well as quality outcomes. Much more research needs to be done to clarify issues around PE hospital purchases. In reading the article, be aware that the topic is not about hospital systems or mergers, which have very different cost and quality profiles.

About pharma

MACPAC calls for states to have power to restrict Medicaid coverage of some accelerated approval drugs “Congress should give states the power to not pay full price under Medicaid for drugs approved under the Food and Drug Administration’s accelerated approval pathway, a key advisory panel said.
The Medicaid and CHIP Payment and Access Commission (MACPAC) released proposals for Congress as part of its March report last week. One of the key recommendations is to limit state coverage under Medicaid of drugs cleared via accelerated approval that have not completed a confirmatory trial. The recommendation is the latest tension point between Medicare and Medicaid regulators and the accelerated approval pathway.”
Comment: Private companies find it hard to turn down coverage for FDA drugs approved through the accelerated pathways and end up paying “full” prices (or at least PBM-set prices). Of course, this process results in higher customer premiums.

US FDA official says agency needs to start using accelerated approval for gene therapies - report “The U.S. Food and Drug Administration needs to start using accelerated approval for advancing gene therapies for rare diseases, STAT News reported on Monday, citing agency official Peter Marks.
Accelerated approval would be particularly important for ultra-rare diseases, for which there are too few patients to run placebo-controlled studies, the report said, quoting Marks, who heads the agency’s Center for Biologics Evaluation and Research.”

About the public’s health

World Obesity Atlas 2023 “The estimates for global levels of overweight and obesity (BMI ≥25kg/m2), also referred to as high BMI throughout this Atlas, suggest that over 4 billion people may be affected by 2035, compared with over 2.6 billion in 2020. This reflects an increase from 38% of the world’s population in 2020 to over 50% by 2035 (figures exclude children under 5 years old).
The prevalence of obesity (BMI ≥30kg/m2) alone is anticipated to rise from 14% to 24% of the population over the same period, affecting nearly 2 billion adults, children and adolescents by 2035.
The rising prevalence of obesity is expected to be steepest among children and adolescents, rising from 10% to 20% of the world’s boys during the period 2020 to 2035, and rising from 8% to 18% of the world’s girls.”

Justice Jackson Dissents Over End Result in Teen’s Abortion Case “Justice Ketanji Brown Jackson dissented Monday from the US Supreme Court’s decision to erase what could be seen as a pro-abortion appeals court ruling from the books.
At issue in the case was a decision by the US Court of Appeals for the Eighth Circuit affirming that a court clerk had to defend a lawsuit alleging that she violated a teenager’s civil rights by refusing to let her proceed with an abortion judicial bypass procedure without first notifying her parents. Judicial bypass is a way for minors to obtain a judge’s permission to have an abortion without involving her parents….”

About healthcare IT

Microsoft’s Nuance adds GPT-4 AI to its medical note-taking tool “An AI medical scribe platform is the latest entrant into the AI arms race. On Monday, Microsoft-owned Nuance Communications announced it is integrating GPT-4 into its Dragon Ambient Intelligence platform, which is used by hospitals around the country to ease doctor workloads by using AI to listen to patient-provider conversations and write medical visit notes.
Starting this summer, all providers currently using DAX or Dragon Medical One will be eligible to apply for an early adopter program for DAX Express, which bypasses the human reviewer used as a quality control in the current DAX product, and returns fully AI-generated notes within minutes of a patient visit. This move marks a decisive acceleration of Nuance’s timeline for transferring all of the responsibility of drafting notes to AI.”

Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal “In this survey study of 8139 respondents at 4 US academic medical centers, 96% of patients preferred receiving immediately released test results online even if their health care practitioner had not yet reviewed the result. A subset of respondents experienced increased worry after receiving abnormal results.”
This study is now moot, since hospitals are required to release results once available; however it is interesting that so many want results, even if they don’t know how to interpret them. Of course, many results are obviously “normal.”

FTC highlights the hidden impacts of pixel tracking in healthcare “The FTC issued a deep dive on pixel tracking technology and how the tools can negatively impact healthcare and consumer data.
In a March 16 post, the FTC listed four concerns about pixel tracking technology:

Consumers may not realize that tracking pixels exist as they're invisibly embedded within web pages that users might interact with.
Pixels can collect and share any type of personal and identifying information.
Some pixels may try to remove personal information from being collected, but may still obtain enough information to identify an individual.
The FTC said companies or organizations using pixel tracking technology that discloses an individual's personal information to third parties may be violating the FTC Act, the FTC's Health Breach Notification Rule, the HIPAA Privacy, Security and Breach Notification Rule.”

About healthcare personnel

Match Day Breaks Records for Numbers of Positions and Applicants FYI

About health technology

A new Medicare ruling could give virtual reality companies an easier path to payment “AppliedVR, a company targeting chronic pain, has become the first digital therapeutic to find an easy way to secure reimbursement from the Centers for Medicare and Medicaid Services.
CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment. The device, which consists of a headset and software guiding patients in pain management exercises, received Food and Drug Administration authorization to treat chronic lower back pain in 2021. Starting in April, providers will be able to bill for AppliedVR’s device as durable medical equipment.”

FDA grants clearance for fast, point-of-care STI test for women “Key takeaways:
—This STI test from Visby Medical provides test results for chlamydia, gonorrhoeae and trichomonas in less than 30 minutes.
—The FDA clearance will allow women to receive test results in a single office visit.”

Zoll alerts 1M wearable defibrillator users to data breach that exposed Social Security numbers “The names, addresses, birthdates and Social Security numbers of more than 1 million users of Zoll Medical’s wearable cardioverter defibrillators may have been exposed in a recent hacking attack.”
Comment: The hackability of such devices and peripherals is well-known.

ICER Aims to Consider Health Equity in Its Product Value Assessments “The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
ICER convened an advisory group made up of patient advocates, payers, health technology and policy experts to help identify ways to evaluate diversity of patients in clinical trials and the opportunities to reduce health disparities.”

Today's News and Commentary

March 20, 2023 Joel Shalowitz

About Covid-19

Long-covid symptoms are less common now than earlier in the pandemic “The analysis of nearly 5 million U.S. patients who had covid, a study based on a collaboration between The Washington Post and research partners, shows that 1 in 16 people with omicron received medical care for symptoms associated with long covid within several months of being infected. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms.”

What we know about the origin of covid-19, and what remains a mystery A great review of the subject. “The most recent discovery, first reported by the Atlantic, involves new data suggesting that raccoon dogs sold in the Huanan Seafood Market could have been the source of the viral spillover. Raccoon dogs are small, fox-like mammals that have been sold illegally in Chinese markets.”

About health insurance/insurers

CMS instructs billing dispute arbitrators to resume processing all decisions “The Centers for Medicare & Medicaid Services on March 17 gave arbitrators the all-clear to resume determinations on out-of-network payment disputes alongside the release of its updated August 2022 final rules.
CMS had been forced to pause Independent Dispute Resolution (IDR) after a Feb. 6 court ruling from the U.S. District Court for the Eastern District of Texas ruled in favor of providers.”

About hospitals and healthcare systems

HHS sued by hospitals over 'delayed' Medicare DSH payments About 40 hospitals across five states have filed a lawsuit against HHS Secretary Xavier Becerra, alleging that yearslong delays in correcting Medicare disproportionate share hospital payments have cost them "tens of millions" of dollars.
The safety-net hospitals in California, Arizona, Nevada, Hawaii and Minnesota filed the lawsuit March 14 in a Washington, D.C., district court.”

Hospital ‘Black Boxes’ Put Surgical Practices Under the Microscope “The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.
The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong.”

About pharma

3 major insulin makers have now slashed the price of the life-saving drug. Here's why. “Amid consumer angst and political pressure over the cost of life-saving insulin, Sanofi announced Thursday it would slash the price of its most-prescribed insulin, Lantus.

Sanofi was the final holdout among three companies that make up 90% of the world's insulin market by value. Earlier in the week, Novo Nordisk followed Eli Lilly Co.'s plans to slash U.S. prices by up to 75% and 70%, respectively.
Sanofi said it will cut the price of Lantus by 78% and short-acting Apidra by 70% as of Jan. 1, 2024.”

California, drugmaker partner to produce affordable insulin “The state of California and a generic drug manufacturer announced a 10-year partnership Saturday to produce affordable, state-branded insulin that they hope will rival longtime producers and push down prices for a medication used by millions of Americans…
The state and its partner, the nonprofit Civica, have yet to locate a California-based manufacturing facility. Regulatory approvals will be needed. Newsom said a 10- milliliter vial of the state-branded insulin would sell for $30, but it’s possible competitors could slash their prices and undercut the state product.”

About the public’s health

PATIENTS LIKELY TO SKIP PREVENTIVE CARE IF ACA RULING HOLDS “KEY TAKEAWAYS

Morning Consult polled a survey of 2,199 American adults to better understand if preventive service utilization would be affected by a recent court ruling eliminating coverage in the Affordable Care Act.
At least two in five respondents say they are not willing to pay for 11 of the 12 preventive services, with cancer screenings chosen as the service most likely to be paid for.
Half of respondents skipped or delayed medical care because of cost, with three in 10 saying they did so in the past year.”

About healthcare IT

VA looking to renegotiate its $10B contract with Oracle Cerner “The Department of Veterans Affairs is trying to negotiate a five-year option period for its $10 billion contract with Oracle Cerner as the EHR modernization program has been troubled since its rollout in 2020…”

IBM, Cleveland Clinic Install World's First Quantum Computer for Health Care Research “Academic medical center Cleveland Clinic today installed the first quantum computer in the world that is uniquely dedicated to health care research – IBM’s Quantum System One. It’s also the first on-site IBM-managed quantum computer for the private sector in the United States.
Cleveland Clinic unveiled the quantum computer in the Lerner Research Institute on its main campus in Cleveland. Jerry Chow, fellow and director of quantum infrastructure research at IBM, noted the company’s quantum computer can be deployed in different environments, and typical research institutes have the ability to meet the environmental requirements.”

American Telemedicine Association announced telehealth innovators challenge victors FYI. It is interesting to see in what areas these innovators are working.

The letter grades EHR vendors get for interoperability FYI

About healthcare personnel

Emergency Department Labor Costs Climb in Early 2023, According to Latest Syntellis Performance Solutions Report “Emergency department (ED) labor costs are on the rise, climbing 50% over the past three years and reaching $186 per visit in January, according to the report which draws data from more than 1,300 hospitals and 135,000 physicians. This trend provides just one example of the long-term effects of inflation, labor shortages, and other economic challenges that continue to strain U.S. healthcare providers in 2023 following a very difficult year in 2022.”

Today's News and Commentary

March 16, 2023 Joel Shalowitz

About Covid-19

FDA authorizes Pfizer’s Covid omicron booster as fourth shot for kids under 5 “KEY POINTS

The U.S. Food and Drug Administration authorized Pfizer’s omicron booster shot for kids younger than five who were previously vaccinated with three doses of the company’s original vaccine.
Children six months through four years old who completed their three-dose primary series with Pfizer and BioNTech’s monovalent shots more than two months ago are now eligible to receive a single booster dose of the updated shot.”

COVID-19 rebound not linked to Paxlovid, FDA says “The FDA reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid and found "no evidence of a higher rate of symptom rebound or moderate symptom rebound."

About health insurance/insurers

Medicaid Redetermination Coverage Transitions “Overall, our modeling finds that in nearly all states, the majority of individuals will transition to employer-provided coverage (EPC). Variation across states ranges from the lowest proportion (48.9%) in Georgia, to the highest proportion (57.1%) in Delaware, enrolling in EPC.
Notably, approximately 3.8 million (or 21.2%) of people who lose Medicaid coverage during redetermination are estimated to become uninsured. Variation ranges from 17.7% in Massachusetts to 26.2% in South Dakota.”
The first line above highlights how expensive EPC is— these individuals would rather accept the limitations of Medicaid rather than enroll in their workplace plan.

March 2023 Report to the Congress: Medicare Payment Policy From MedPAC. Read (or scan) the 25- page executive summary, it touches on all aspects of Medicare payments. Remember, MedPAC’s recommendations are only advisory. It is also important to note that: “Because of standard data lags, the most recent complete data we have for most payment adequacyindicators are from 2021.”

Association of Participation in a Value-Based Insurance Design [VBID] Program With Health Care Spending and Utilization “This retrospective cohort study included 94 127 enrollees in commercial health plans. The VBID cohort was associated with significantly higher spending on or use of primary care physicians and immunizations, lower inpatient admissions and surgical procedures, and similar changes in overall spending compared with a non-VBID cohort in 2019 or 2020.”

About hospitals and healthcare systems

The Estimated Value of Tax Exemption for Nonprofit Hospitals Was Nearly $28 Billion in 2020 “The total estimated value of tax exemption for nonprofit hospitals was nearly $28 billion in 2020 (Figure 1). This represented over two-fifths (43%) of net income (i.e., revenues minus expenses) earned by nonprofit facilities in that year. To put the value of tax exemption in perspective, our estimate is similar to the total value of Medicare and Medicaid disproportionate share hospital (DSH) payments in the same year ($31.9 billion in fiscal year 2020)…”

17 called-off hospital deals FYI

About pharma

Factors Associated With Public Trust in Pharmaceutical Manufacturers This cross-sectional study used a nationally representative survey of 2867 individuals at risk of cardiovascular disease (mean [SD] age, 54 [7] years; 1324 women [46%] and 2119 White individuals [74%]). A total of 1145 individuals (40%) considered pharmaceutical manufacturers to be sometimes (1036 [36%]) or always (109 [4%]) trustworthy….
Excellent health (OR, 1.70 [95% CI, 1.05-2.75]; P = .03) and having a regular source of care (OR, 1.19 [95% CI, 1.01-1.40]; P = .03) were associated with higher trust in pharmaceutical manufacturers…Individuals with Democratic (OR, 1.35 [95% CI, 1.15-1.61]; P < .001) or Republican party affiliation (OR, 1.27 [95% CI, 1.09-1.49]; P = .003) had higher trust relative to those with Independent affiliation. Relative to the west, individuals in the northeast had higher trust (OR, 1.43 [95% C, 1.16-1.77]; P = .001). There were no differences across gender, race and ethnicity, age, income, or educational level.”
Check the tables in the article.

FACT SHEET: Seniors Across the Country Are Saving Millions of Dollars in Health Care Costs Because of President Biden’s Prescription Drug Law This Whitehouse statement, stripped of the political rhetoric, lists 27 drugs whose prices rose faster than inflation and whose manufacturers are subject to fines.

About the public’s health

2023’s Most Overweight and Obese Cities in the U.S. FYI

Many Americans Are Likely to Skip Preventive Care if ACA Coverage Falls Through In September, [Judge Reed] O’Connor ruled that it is unconstitutional to require insurers to cover preventive services, with no cost-sharing for patients, that are recommended by an independent adviser. The judge did not issue a remedy at the time of the ruling, however, and still has yet to release one…
At least 2 in 5 U.S. adults said they are not willing to pay for 11 of the 12 preventive services currently covered by the ACA, according to a new Morning Consult survey. Furthermore, at least half said they would not pay out of pocket for preventive services such as tobacco cessation or screenings for HIV, depression and unhealthy drug use.”

Incidence of Aggressive End-of-Life Care Among Older Adults With Metastatic Cancer Living in Nursing Homes and Community Settings “Question Is receipt of aggressive end-of-life (EOL) care for older adults with metastatic cancer more common among nursing home (NH) residents or their community-dwelling counterparts?
Findings This cohort study of 146 329 older adults found that aggressive EOL care was more common for NH residents than for community-dwelling residents (64% vs 58%). The key markers associated with the higher prevalence of aggressive EOL care were more than 1 hospital admission in the last 30 days of life and in-hospital death.”

West Nile, Lyme, and other diseases are on the rise with climate change. Experts warn the U.S. is not prepared “Tick-borne diseases comprise the largest share of vector-borne diseases by far — over 80% of reported cases are caused by ticks. Longer summers, rising temperatures, and the expanding ranges of tick species such as Ixodes scapularis, the black-legged tick, and Amblyomma americanum, the lone star tick, are leading to an increased chance of human exposure to pathogens over a larger geographic area.

Remote Cardiovascular Hypertension Program Enhanced Blood Pressure Control During the COVID‐19 Pandemic “A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring despite a nationally observed disruption of traditional hypertension care. Such programs have the potential to transform hypertension management and care delivery.”
From the patient perspective, the remote technology improves cost, quality and access. However, from the provider standpoint, there needs to be a business model for such care, e.g., telemedicine charges or capitation.

About healthcare IT

Associations Between Natural Language Processing–Enriched Social Determinants of Health and Suicide Death Among US Veterans “Question Are social determinants of health (SDOHs), extracted from both structured and unstructured clinical data, associated with an increased risk of suicide death among US veterans?
Findings In this case-control study of 8821 cases and 35 284 matched controls, SDOHs from both structured data and unstructured data (extracted using a natural language processing system) were associated with an increased risk of suicide death.
Meaning The findings of this study suggest that SDOHs are risk factors for suicide among the US veterans and that natural language processing can be leveraged to extract SDOH information from unstructured data.”

2023’s Largest Health Data Breach So Far Brings Legal Flurry “Regal Medical Group disclosed last month that over 3.3 million patients had their personal and health information exposed in a December 2022 ransomware cyberattack. The US Department of Health and Human Services says the breach is currently the biggest reported to it in 2023. The agency’s Office for Civil Rights is also investigating it.
At least 11 lawsuits, all in California, were filed in the three weeks following Regal’s February disclosure, according to a Bloomberg Law analysis of court dockets. They seek monetary damages ranging between $100 and $3,000 per class member, and several want Regal and its affiliates to ensure they will prevent similar incidents from happening again.”

Google launches Open Health Stack for app developers, unveils new AI partnerships

Yesterday, Google “unveiled new AI partnerships focused on cancer screenings and maternal health and efforts to give Fitbit users easier access to health and wellness data from their devices…
The company also announced that it’s making it easier for people to find affordable healthcare centers near them. Consumers will be able to see providers that identify as community health centers offering free or low-cost care…”

About health technology

Poll Says American Consumers Want FDA Regulation of Medical Device Repair “According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.”
Never thought about the fact that an FDA-approved device can malfunction and be “fixed” by someone with questionable skills.

PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company “PerkinElmer has completed the split it announced last August, selling off its applied science, food and enterprise services businesses to private equity firm New Mountain Capital and combining the remaining life sciences and diagnostics businesses into a new, standalone company.
While the businesses sold to New Mountain will retain the PerkinElmer name, the newly formed medtech supplier will go by a different moniker—though its name, logo and ticker symbol have yet to be announced.

Today's News and Commentary

March 15, 2023 Joel Shalowitz

About Covid-19

FDA authorizes Pfizer’s Covid omicron booster as fourth shot for kids under 5 “KEY POINTS

The U.S. Food and Drug Administration authorized Pfizer’s omicron booster shot for kids younger than five who were previously vaccinated with three doses of the company’s original vaccine.
Children six months through four years old who completed their three-dose primary series with Pfizer and BioNTech’s monovalent shots more than two months ago are now eligible to receive a single booster dose of the updated shot.”

About health insurance/insurers

About hospitals and healthcare systems

17 called-off hospital deals FYI

About pharma

About the public’s health

2023’s Most Overweight and Obese Cities in the U.S. FYI

About healthcare IT

Google launches Open Health Stack for app developers, unveils new AI partnerships

About health technology

Today's News and Commentary

March 14, 2023 Joel Shalowitz

About Covid-19

A meta-analysis of the associations between insufficient sleep duration and antibody response to vaccination “Highlights
—Insufficient sleep (<6 hours/night) around vaccination reduces the antibody response
—The reduction is similar to the waning of COVID-19 vaccine antibodies over 2 months
—The association seems robust in men, but more data are needed in women
—Optimizing sleep duration around the time of vaccination may boost antibody response”

COVID-19 and Outpatient Antibiotic Prescriptions in the United States: A County-level Analysis “[Overall] antibiotic prescribing fell 26.8% in 2020 compared to prior years…
The positive association of COVID-19 cases with prescribing for all ages and the negative association for children indicates increases in prescribing occurred primarily among adults. The rarity of bacterial co-infection in COVID-19 patients suggests a fraction of these prescriptions may have been inappropriate. Facemasks and school closures were correlated with reductions in prescribing among children, possibly due to the prevention of other upper respiratory infections. The strongest predictors of prescribing were prior years’ prescribing trends, suggesting the possibility that behavioral norms are an important driver of prescribing practices.”

About health insurance/insurers

Inside the mind of criminals: How to brazenly steal $100 billion from Medicare and Medicaid “Taxpayers are losing more than $100 billion a year to Medicare and Medicaid fraud, according to estimates from the National Health Care Anti-Fraud Association.”
The article provides examples of the ease with which fraud is committed.

Consistency of Physician Data Across Health Insurer Directories “In examining directory entries for more than 40% of US physicians, inconsistencies were found in 81% of entries across 5 large national health insurers. These results were driven by inconsistencies in addresses among physicians listed as practicing at multiple locations, which is concordant with prior research suggesting that most address errors stem from group practices reporting all physicians at all practice locations to insurers, irrespective of each individual physician’s practice locations.”

About hospitals and healthcare systems

Hospital Vitals: Financial and Operational Trends “The latest Hospital Vitals report — published in partnership with the American Hospital Association (AHA) — shares year-end 2022 data from 1,300+ hospitals and health systems. Key findings comparing hospitals’ 2022 performance to 2019 include:  
—Total Contract Labor Expense skyrocketed 257.9%
—Contract Labor FTEs jumped 138.5%
—Median Contract Wage Rate paid to staffing firms rose 56.8%
—Emergency Overtime Hours per ED Visit increased 22%”

Patient Safety Excellence Award 2023 View hospitals by state.

About pharma

Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US “On Tuesday, the Danish company said it would reduce the list price of its NovoLog insulin by 75% and slice the cost of Novolin and Levemir by 65%. The cuts will kick in on Jan. 1 of 2024, the drugmaker said.
The company also will drop the price of its unbranded biologics to match the reduced prices of the branded insulins.”
Why wait so long?

United States Files Complaint Alleging that Rite Aid Dispensed Controlled Substances in Violation of the False Claims Act and the Controlled Substances Act “ ‘We allege that Rite Aid filled hundreds of thousands of prescriptions that did not meet legal requirements,’ said Associate Attorney General Vanita Gupta. ‘According to our complaint, Rite Aid’s pharmacists repeatedly filled prescriptions for controlled substances with obvious red flags, and Rite Aid intentionally deleted internal notes about suspicious prescribers. These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores.’”

About the public’s health

EPA proposes rules to limit ‘forever chemicals’ in drinking water “The Environmental Protection Agency is proposing the nation’s first-ever drinking-water standards for a group of human-made chemicals — commonplace in consumer items — that pose a greater danger to human health than scientists once thought.
The proposal could force water utilities to spend billions of dollars to comply with the EPA’s planned limits on polyfluoroalkyl and perfluoroalkyl substances, or PFAS, even though those limits are less stringent than advisory levels for safe consumption the agency set last year. Officials say that small and rural utilities will have access to federal subsidies and assistance, blunting the financial impact of the rule, if enacted.”

About healthcare personnel

Docs diverge on DTC, with survey showing support among the young “Among the healthcare professionals who see value in DTC marketing, more than 50% of the respondents said increased patient knowledge of medications helps with diagnosis and 70% said it boosts treatment adherence. The upshot? Campaigns that create informed patients could potentially improve outcomes.
Support diverges by age. Two-thirds of people aged 25 to 34 have no issues with the practice, compared to less than 40% of practitioners aged 45 and older. The data suggest views on DTC ads are shifting.”

Poll Finds More Americans Worried About Health Care Understaffing “More than a third (35%) of people noticed or had been affected by health care staffing shortages at the time of the February poll, up from 25% last November, noted Kathy Steinberg, vice president of media and communications research at the Harris Poll.
By comparison, 24% had been affected by staffing shortages in education in February, up from 17% in November.”

About health technology

Apple AirPods could be getting health features soon “Apple's AirPods and AirPods Pro might be used to monitor heart rates and characterize blood flow in consumer's ear skin, Apple Insider reported March 12.
Apple has filed patents and patent applications for a biometric sensing capability for the AirPods package, according to the report, suggesting that the company might use the device's ear and a photoplethysmogram sensor to monitor health conditions.”

About healthcare finance

Seeking to boost shareholder returns, Novartis readies new $11B buyback round “Novartis is preparing to kick off a share buyback round aimed at repurchasing up to 10 billion Swiss francs ($11 billion) worth of company shares in the next three years.
The new initiative, greenlighted at Novartis’ annual general meeting last week, will see the Swiss pharma buy up to 10% of its own registered stock.”

Today's News and Commentary

March 13, 2023 Joel Shalowitz

About Covid-19

House votes to declassify info about origins of COVID-19 The House voted unanimously Friday to declassify U.S. intelligence information about the origins of COVID-19, a sweeping show of bipartisan support near the third anniversary of the start of the deadly pandemic.
The 419-0 vote was final congressional approval of the bill, sending it to President Joe Biden’s desk. It’s unclear whether the president will sign the measure into law, and the White House said the matter was under review.”

QuidelOrtho Gains De Novo Authorization for COVID-19 Test “QuidelOrtho has received FDA’s de novo authorization for its Sofia 2 SARS Antigen+ FIA rapid test for COVID-19 — making it the first antigen test for COVID-19 to gain a full authorization rather than an emergency use authorization from the agency.”
Emphasis added.
Hard to believe this is the first non-EUA 3 years after the pandemic was declared.

About quality and safety

Pediatric mental health, workplace violence are top 2023 safety concerns: ECRI It is well worth following this report annually, not only to focus on the current list, but to compare it with previous years’ lists. The article goes back to 2020. It is not only a reflection of current science as well as prevalent social factors.

About hospitals and healthcare systems

Hospitals Barred From Suing HHS Over Uncompensated Care Pay “Forty-five hospitals that the HHS allegedly underpaid for providing uncompensated care to low-income people can’t challenge the agency’s methodology for calculating those payments.
The Medicare Act bars agency and judicial review of the US Health and Human Services Department’s estimates for determining hospitals’ disproportionate share payments, the US Court of Appeals for the D.C. Circuit said Friday.
It also renders unreviewable HHS’ instructions for auditing a form that hospitals use to report their uncompensated care for the ultimate purpose of calculating DHS payments, the court said.”

Ascension operating margin falls to -2.9% “St. Louis-based Ascension saw its operating margin fall to -2.9 percent in the six months ending Dec. 31, 2022, down from 0.2 percent for the same period in 2021 and 5.7 percent in 2020, according to its most recent financial report.
The 139-hospital system recorded a $410 million operating loss in the second half of 2022, compared with an operating income of $31 million during the same period last year.”

About pharma

More than one-third of Americans haven’t filled a prescription due to cost: survey “That’s according to a poll completed by 1,500 U.S. adults in March 2023. Of these, 37 percent said they’ve not filled a prescription due to cost. Another 10 percent preferred not to answer the query.
Both women and individuals with an annual family income less than $50,000 were more likely to say they’ve skipped filling prescriptions due to cost, at 43 percent and 44 percent, respectively.
However, similar shares of Democrats and Republicans said they’ve had this experience, poll results show.”
Highlights the need for pharma payment reform. Generics have saved billion of dollars but some people need expensive medications to live. Charging high rates for non-discretionary services is cruel and counterproductive, as noncompliance often results in the need for more expensive care.

Medicare Part D Coverage of Antiobesity Medications — Challenges and Uncertainty Ahead “The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment organization based in the United States, recently evaluated the cost-effectiveness of lifetime use of semaglutide and three other antiobesity-medication regimens (brand-name liraglutide, phentermine–topiramate, and bupropion–naltrexone; including generic versions of phentermine and topiramate, and bupropion and naltrexone) for a 45-year-old patient as compared with lifestyle modification alone. ICER’s evaluation concluded that semaglutide wasn’t cost-effective, with an estimated cost of $237,000 per quality-adjusted life-year gained…
Under current U.S. thresholds, the annual $13,618 price of semaglutide would need to decrease to $7,500 to $9,700 for the drug to be cost-effective as compared with lifestyle modification alone.In that price range, however, it still wouldn’t be cost-effective as compared with generic phentermine and topiramate. Even with such discounted prices, the budgetary effects for Medicare could be substantial.”
Bottom line is a $26.8B annual price tag for one drug.

Gambian child deaths fuel alarm over rules in ‘world’s biggest pharmacy’ India Although this article uses examples from Gambia, the “deaths have sparked concerns about quality control in India, the self-styled pharmacy of the world, as well as under-resourced regulatory agencies in low-income nations…
India, which has 20 per cent of the global market for generic drugs, supplies more than 50 per cent of generic drugs sold in Africa, according to Invest India, the government’s national investment promotion and facilitation agency.”
The FDA does not have enough personnel or money to comprehensively cover foreign sources of food and drugs.

The top 10 drugs losing US exclusivity in 2023 To get an idea of the impact of generic equivalents, subtract about 15% from biologics (frequently ending in “ab” or “ib”) and 80% from non-biologic products. The caveat is that, like any other goods, there has to be sufficient competition to bring those numbers down.

Veterans Health Administration will cover the newest Alzheimer’s drug “In an unexpected move, the Veterans Health Administration announced Monday that it will widely cover a new Alzheimer’s treatment, even as Medicare has decided to wait for additional data about the medicine before taking the same step.
The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment. About 80% to 90% of veterans who clear these hurdles may be eligible for the treatment, but the exact number is uncertain…”

About the public’s health

Long-term intensive endurance exercise training is associated to reduced markers of cellular senescence in the colon mucosa of older adults “Our data suggest that chronic high-volume high-intensity endurance exercise can play a role in preventing the accumulation of senescent cells in cancer-prone tissues like colon mucosa with age. Future studies are warranted to elucidate if other tissues are also affected, and what are the molecular and cellular mechanisms that mediate the senopreventative effects of different forms of exercise training.”

Massachusetts could become the next state to allow aid in dying A really good review of the topic, including legal status among the states.

E-Cigarette Screening in Primary Care “Overall rates of e-cigarette screening were significantly lower than that of other substances. Use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be due to the relatively recent proliferation of e-cigarettes, the recent addition of e-cigarette documentation to the electronic health record, or a lack of training on screening for e-cigarette use.”

About healthcare IT

Commercially available AI tool could reduce radiologist workloads by 10% or more “The AI tool was able to correctly classify 28% of the images labeled as normal. This equates to approximately 7.8% of the entire cohort that could be safely classified using AI alone.
The tool’s sensitivity was recorded as 99.1% for abnormal radiographs and 99.8% for critical radiographs—better than two board-certified radiologists who also interpreted the exams.”
A reminder about how good AI is getting at reading images.

Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need Really good discussion of the topic. In short: “Behind the scenes, insurers are using unregulated predictive algorithms, under the guise of scientific rigor, to pinpoint the precise moment when they can plausibly cut off payment for an older patient’s treatment. The denials that follow are setting off heated disputes between doctors and insurers, often delaying treatment of seriously ill patients who are neither aware of the algorithms, nor able to question their calculations.”

About healthcare finance

With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs' “It is the largest acquisition in biopharma since June of 2019, when AbbVie acquired Allergan for $63 billion. Five months before that, Bristol Myers Squibb pulled off the biggest transaction in industry history with its $74 billion purchase of Celgene.
Seagen, long considered one of the world’s most attractive biotech targets, brings four commercial medicines and a deep pipeline full of antibody-drug conjugate (ADC) candidates.”

Sanofi throws down $2.9B to acquire diabetes partner Provention Bio “The deal gives Sanofi access to Provention’s approved immunotherapy Tzield, greenlighted in November, which is designed to stall progression of type 1 diabetes.”

Today's News and Commentary

March 10, 2023 Joel Shalowitz

Biden's $6.8T budget: 15 healthcare takeaways A good, short summary of the proposals.
See, also, a related article: What Biden's proposed budget means for Medicare Advantage

About healthcare quality

Accounting for Person- vs Neighborhood-Level Social Risk in Quality Measurement A good discussion of the pros and cons of each method. The article is a commentary on another article in the same journal issue.
The crux of the analysis is: “ Ultimately, 3 social risk factors were identified, one of which was a patient-level variable (Medicare-Medicaid dual-enrollment status) and 2 of which were community-level measures of social risk, including low Agency for Healthcare Research and Quality Socioeconomic Status (AHRQ SES) Index (an aggregated score of neighborhood vulnerability based on employment, income, education, and housing) and low physician-specialist density (a marker for reduced access to specialty care).”

About health insurance/insurers

Medicaid Health Plans Try to Protect Members — And Profits — During Unwinding “The plans have a strong financial incentive to keep their members enrolled because states pay them per member, per month: The more people they cover, the more money they get.
The Biden administration estimates that 15 million of the more than 91 million Medicaid enrollees will fall off the rolls, nearly half because their income exceeds program limits and the rest because they fail to complete the reenrollment paperwork.
Of the people losing eligibility, about two-thirds will enroll in a workplace health plan, health insurers predict, and the other third will be evenly divided between ACA plans and being left uninsured…
Investor-owned companies earn pretax profit margins of about 3% on average from Medicaid managed care, slightly below what they make on ACA marketplace business, he said. So moving members to an ACA plan could boost the profits of these companies.”

Industry groups form coalition to avoid coverage lapses as Medicaid redeterminations loom “The Connecting to Coverage Coalition is spearheaded by AHIP, the health insurance industry's largest lobbying group, and its other founding members include the American Cancer Society Cancer Action Network, the Federation of American Hospitals, the Blue Cross Blue Shield Association and the Association for Community Affiliated Plans.
The national effort is seeking to provide a single source for information about the redetermination process and to build solutions that ensure people are able to find the coverage the works best for them and their families, according to an announcement.”

How Obamacare Enabled a Multibillion-Dollar Christian Health Care Cash Grab Ever wonder how the “Health Sharing Ministries” are legally able to operate health plans, despite the negative news about their performances? Their enablement was written into the ACA. This ProPublica article provides a great insight into these plans.

About hospitals and healthcare systems

Providence reports $1.7B operating loss in 2022 “Renton, Wash.-based Providence, a 51-hospital system, has reported a $1.7 billion operating loss for fiscal 2022 amid labor and inflationary pressures as well as delayed reimbursements. Investment losses also further dragged the system's performance down.”

About the public’s health

WHO global report on sodium intake reduction The report can be downloaded from this site. Briefly: “The largest number of diet-related deaths, an estimated 1.89 million each year, is associated with excessive intake of sodium, a well-established cause of raised blood pressure and increased risk of cardiovascular disease. The global average sodium intake is estimated to be 4310 mg/day (10.78 g of salt per day), which far exceeds the physiological requirement and is more than double the World Health Organization (WHO) recommendation of <2000 mg of sodium (equivalent to <5 g of salt) per day in adults.
Reducing sodium intake is one of the most cost-effective ways to improve health and reduce the burden of noncommunicable diseases, as it can avert a large number of cardiovascular events and deaths at very low total programme costs. WHO recommends several sodium-related best buys policies as practical actions that should be undertaken immediately, to prevent cardiovascular disease and its associated costs. These include lowering sodium content in food products; implementing front-of-pack labelling to help consumers select food products
with lower sodium content; conducting mass media campaigns to alter consumer behaviour around sodium; and implementing public food procurement and service policies to reduce sodium content in food served or sold.
All 194 Member States committed to reducing population sodium intake by 30% by 2025, demonstrating strong consensus on sodium reduction as a life-saving strategy.”

FDA mandates breast density information with mammography results “The U.S. Food and Drug Administration said on Thursday all mammography facilities in the country will be required to notify patients about the density of their breast tissues, as that can potentially make detection of tumors more difficult…
The agency recommends patients with dense breasts, a normal and common finding in mammograms, to discuss their individual situation with their respective healthcare providers.”
Comment: While more informed patients is a laudable goal, without clear criteria for making this determination, the number of unnecessary extra tests (and costs) will skyrocket.

Smoking, snuff use in pregnancy raises risk for sudden infant death syndrome “Children of mothers who used snuff or smoked during pregnancy had higher risks for postneonatal mortality, sudden infant death syndrome and sudden unexpected infant death, according to study results published in Pediatric Research.”

Covid backlash hobbles public health and future pandemic response “At least 30 states, nearly all led by Republican legislatures, have passed laws since 2020 that limit public health authority, according to a Washington Post analysis of laws collected by Kaiser Health News and the Associated Press as well as the Association of State and Territorial Health Officials and the Center for Public Health Law Research at Temple University.
Health officials and governors in more than half the country are now restricted from issuing mask mandates, ordering school closures and imposing other protective measures or must seek permission from their state legislatures before renewing emergency orders, the analysis showed.”

Association of Primary Care Visit Length With Potentially Inappropriate Prescribing “In this cross-sectional study of 4 360 445 patients, those who were younger, publicly insured, Hispanic, or non-Hispanic Black had shorter primary care physician visits. Shorter visits were associated with a higher likelihood of inappropriate antibiotic prescribing for patients with upper respiratory tract infections and coprescribing of opioids and benzodiazepines for patients with painful conditions.”

About healthcare IT

Cerner contributes $1.5B to Oracle's Q3 revenue EHR vendor Cerner contributed $1.5 billion to software giant Oracle's $12.4 billion in third-quarter revenue; analysts at FactSet had expected $12.43 billion in revenue.
The company's quarterly revenue was up 18 percent year-over-year. Cloud revenue contributed $4.1 billion to the total third-quarter revenue, according to an Oracle March 9 news release.”

3.2 million patients caught in Cerebral data breach “More than 3 million patients were affected in a data breach involving telemental health company Cerebral, according to a notice to HHS' Office of Civil Rights.
Cerebral, whose clinicians prescribe medications for depression and anxiety via telehealth, started notifying patients March 6 that some of their data may have been sent to social media companies via consumer-tracking pixel tools.”

Today's News and Commentary

March 9, 2023 Joel Shalowitz

The 2023 Healthcare Marketers Trend Report: A trim off the top “…per the MM+M/Swoop 2023 Healthcare Marketers Survey, marketing budgets slid by 8%.
The average marketing budget fell to $7.6 million, down from $8.3 million in last year’s survey. That spending level is a long way off the pre-pandemic boom times of 2019, when the average budget reached a peak of $12.5 million…
One exception to the belt-tightening trend is physician outreach, as 51% of respondents reported that they’d fattened those budgets. The result: Spending aimed at HCPs [health care personnel] now accounts for 53% of the marketing pie.”
Well worth a read for those interested in marketing.

About Covid-19

Diabetes drug proves beneficial in preventing long COVID in clinical trials “COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial.
The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine.
About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19.”

About hospitals and healthcare systems

10 health systems reporting profits in 2022 Amidst all the losses, this article is some good news.

About pharma

WeightWatchers buys Sequence to expand into remote prescribing of hot weight loss drugs “The well-known weight loss company has entered into a definitive agreement to acquire Weekend Health, the corporate name of Sequence. Clinicians use the platform to provide clinical care, including prescriptions, for patients navigating chronic weight management. Sequence also claims to help patients traverse the insurance approval process.”

Pain Clinic Owners Sentenced for Unlawfully Distributing Opioids and Multimillion-Dollar Health Care Fraud While these cases are, sadly, too common, this one is especially large.
"According to court documents and evidence presented at trial, Mark Murphy and Jennifer Murphy owned and operated North Alabama Pain Services (NAPS), which closed its Decatur and Madison offices in early 2017…. Over the approximately five-year period leading up to the clinic closing its Alabama locations, the evidence at sentencing showed, Murphy wrote prescriptions for more than ten million opioid pills, including millions of oxycodone 30 mg tablets. During the same five-year period, Murphy and his wife Jennifer, who helped run the clinics, ordered tens of millions of dollars of unnecessary items and services that were paid by taxpayer-funded and private insurance programs. The Murphys received kickbacks for those orders and prescriptions. In all, Medicare, TRICARE, and Blue Cross Blue Shield of Alabama were billed more than $280 million as a result of the fraud and kickback schemes, and paid more than $50 million. Mark Murphy and Jennifer Murphy were each ordered to pay more than $50 million in restitution. Jennifer Murphy was also convicted of tax-related charges for underreporting clinic income.”
Emphasis added.

FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt “Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s ‘protracted’ approval process for its financial problems.
Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.
The FDA ultimately authorized Lucira’s test with fewer samples than the agency had previously said it would require for approval…”

About the public’s health

What running does to the knees, according to a large survey of marathon runners “A new study found that runners were not more likely to develop hip or knee osteoarthritis the longer, faster and more frequently they ran.”

Biden administration requests $20 billion cash infusion to bolster public health “In its budget request to Congress on Thursday, the White House asked for $20 billion over five years to support pandemic preparedness efforts at the Administration for Strategic Preparedness and Response, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration. The request aligns with the White House’s National Biodefense Plan.”

About healthcare IT

Healthcare data breaches “2022 has 717 reported breaches so far, just surpassing 2021's total of 715.”
The article lists the top 10 by people affected.

And in a related story: Data breach hits 'hundreds' of lawmakers and staff on Capitol Hill “A top House official said that a ‘significant data breach’ at the health insurance marketplace for Washington, D.C., on Tuesday potentially exposed personal identifiable information of hundreds of lawmakers and staff.
In a letter obtained by NBC News, Chief Administrative Officer Catherine L. Szpindor said Wednesday that the U.S. Capitol Police and the FBI had alerted her to a data breach at DC Health Link, the Affordable Care Act online marketplace that administers health care plans for members of Congress and certain Capitol Hill staff.”

HHS Partners with the Private Sector to Enhance Cybersecurity across Health Systems and Address Future Vulnerabilities Yesterday, “the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), released a cybersecurity implementation guide to help the public and private health care sectors prevent cybersecurity incidents. The Cybersecurity Framework Implementation Guide provides specific steps that health care organizations can take immediately to manage cyber risks to their information technology systems…
[The guide] was jointly developed by HHS ASPR and the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group, a public-private partnership under Presidential Policy Directive 21. The National Institute for Standards and Technology (NIST) and other federal agencies contributed substantially to its content. Recent high-profile cyberattacks reinforce the need for companies and organizations to assess their cyber health and resilience and take actions to improve cybersecurity.”
About healthcare personnel

Job Cuts Hit 77,770 In February 2023; Highest YTD Since 2009 “The Health Care/Products space, which includes hospitals and health care products manufacturers, announced the second-most cuts in February with 9,749, for a total of 16,482 this year. That is an 85% increase from the 8,928 cuts announced during the same time last year.”

Patient perspectives: How patients find and pick their doctors “Here are 3 key takeaways from this year’s findings
An online presence is non-negotiable for attracting new patients
3 in 4 people look online to find out about doctors, dentists, or medical
care — and it’s especially important when people are searching for new care providers. A website is just the start; pay attention to reviews, online directories, and other digital touchpoints.
Text message is still the most popular way to contact patients about appointments Patients appreciate when their healthcare provider keeps them informed about appointments (when they need to be scheduled, when they’re coming up, follow-up information, etc.). For most of these reminders, patients prefer digital interactions, including text messaging.
Patients would engage in social media with providers if they could
Only 18% of respondents said they follow their doctor’s office on social media, but 45% said they would if their doctor posted regularly. Social media is a missed opportunity for practices to engage with patients outside the office.”

About healthcare finance

Fierce Biotech Fundraising Tracker '23 FYI “Like last year's tracker, we will continue to include any fundraising rounds north of $30 million. We'll still profile exciting new companies and larger rounds in-depth, but we’re hoping to focus more coverage on clinical trial results, special reports and enterprise stories…”

Today's News and Commentary

March 8, 2023 Joel Shalowitz

About health insurance/insurers

Moody's: Insurers should expect slower earnings growth this year “The report found that earnings before interest, taxes, depreciation and amortization growth for publicly traded insurers was 12% for the full year 2022. Their financial performance got a boost from suspended Medicaid redeterminations, reduced COVID-19 costs and strong growth on the Affordable Care Act's (ACA's) exchanges.
The analysts expect that earnings growth this year will slow compared to 2022 as the redeterminations resume but that Medicare Advantage (MA) will remain a bright spot.”

Medicaid/CHIP Enrollment Will Grow To Nearly 95M by the End of March, Analysis Predicts “By the end of March, Medicaid/CHIP enrollment will have grown by 23.3 million members since the start of the pandemic, according to a Kaiser Family Foundation report. This is largely due to the continuous enrollment provision enacted during the pandemic, which barred states from disenrolling members and is set to expire March 31.”

About pharma

Accelerated approval drug labels often lack information for clinical decision making “253 clinical indications corresponding to 146 drugs received accelerated approval. We identified a total of 110 accelerated approval indications across 62 drugs that had not received full approval by December 31, 2020. A total of 13% of labels for accelerated approved indications lacked sufficient information that approval was via the accelerated approval or based on surrogate outcome measures: 7% did not mention accelerated approval but described surrogate markers, 4% did not mention accelerated approval nor describe surrogate markers, and 2% mentioned accelerated approval but did not describe surrogate markers. No label described the clinical outcomes being evaluated in post-approval commitment trials.”

About the public’s health

Trust In US Federal, State, And Local Public Health Agencies During COVID-19: Responses And Policy Implications “Public health agencies’ ability to protect health in the wake of COVID-19 largely depends on public trust. In February 2022 we conducted a first-of-its-kind nationally representative survey of 4,208 US adults to learn the public’s reported reasons for trust in federal, state, and local public health agencies. Among respondents who expressed a ‘great deal’ of trust, that trust was not related primarily to agencies’ ability to control the spread of COVID-19 but, rather, to beliefs that those agencies made clear, science-based recommendations and provided protective resources. Scientific expertise was a more commonly reported reason for “a great deal” of trust at the federal level, whereas perceptions of hard work, compassionate policy, and direct services were emphasized more at the state and local levels. Although trust in public health agencies was not especially high, few respondents indicated that they had no trust. Lower trust was related primarily to respondents’ beliefs that health recommendations were politically influenced and inconsistent. The least trusting respondents also endorsed concerns about private-sector influence and excessive restrictions and had low trust in government overall. Our findings suggest the need to support a robust federal, state, and local public health communications infrastructure; ensure agencies’ authority to make science-based recommendations; and develop strategies for engaging different segments of the public.” Emphasis added.

About health technology

U.S. FDA clears Abbott's blood test for concussions “The U.S. Food and Drug Administration has cleared Abbott Laboratories' blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday.
The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI.”

Today's News and Commentary

March 7, 2023 Joel Shalowitz

About Covid-19

U.S. to lift covid testing requirements on travelers from China “U.S. officials are set to relax coronavirus testing requirements on travelers from China as soon as Friday, a decision that comes amid declining covid cases in that country, according to three officials who spoke on the condition of anonymity to describe the plan.
The White House declined to comment on the plan, which the officials said was being finalized on Tuesday.”

About health insurance/insurers

Joe Biden: My Plan to Extend Medicare for Another Generation Basically comes down to increasing negotiations to lower pharmaceutical costs and raising taxes on unearned income.

CMS ISSUES PAYMENT AND COVERAGE GUIDANCE AS PANDEMIC WAIVERS APPROACH EXPIRATION This article is a good summary of the many changes after the PHE expires.

The Challenges of Choosing Medicare Coverage: Views from Insurance Brokers and Agents “Most brokers and agents said they personally would choose traditional Medicare with Medigap, believing that combination offers better coverage and choices than Medicare Advantage, particularly as people age.”

10 Medicare Advantage startups with the most venture funding FYI. It will be difficult to find profitability data as many of these companies become part of larger corporations. Recently, Bright Health reported a net loss of $1.4 billion in 2022, compared to a $1.2 billion loss a year prior. Oscar Health recorded a net loss of $606 million in 2022, compared to a net loss of $572 million in 2021.

About pharma

Cuban breaks into brand-name drug market “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban's pharmacy.”

California to not do business with Walgreens over abortion pills issue, Governor says “California will not do business with Walgreens Boots Alliance Inc state Governor Gavin Newsom said in a tweet on Monday, days after the pharmacy chain said it would not dispense abortion pills in some Republican-dominated states.
The state refuses to do business with Walgreens or ‘any company that cowers to the extremists and puts women's lives at risk,’ said Newsom, a Democrat.
A spokesperson for the governor said ‘all relationships’ between Walgreens and the state were now under review but declined to detail how business ties might change.”

From one store in Massachusetts to $105B healthcare giant: A timeline of CVS' disruption FYI

FDA Grants Leqembi Priority Review for Full Approval “The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA) to traditional approval.”

About the public’s health

Vitamin D supplementation and incident dementia: Effects of sex, APOE, and baseline cognitive status “Across all formulations, vitamin D exposure was associated with significantly longer dementia-free survival and lower dementia incidence rate than no exposure (hazard ratio = 0.60, 95% confidence interval: 0.55–0.65). The effect of vitamin D on incidence rate differed significantly across the strata of sex, cognitive status, and APOE ε4 status.”

About healthcare IT

Key Drivers of Clinician EHR Satisfaction “Similar to a net promoter score, the NEES [Net EHR Experience Score] represents the overall landscape of clinician satisfaction with the EHR…”
Look at the charts for the essential findings of the survey. For example, the top two areas for improvement are system efficiency enablement and response time.

About health technology

A Novel Breakthrough in Wrist-Worn Transdermal Troponin-I-Sensor Assessment for Acute Myocardial Infarction Troponin is assayed in the blood when a patient is suspected of having a heart attack.
The test is almost always done the the ER or hospital. This technology would allow a non-invasive test to be used in the patient’s everyday environment.
”A wrist-worn transdermal infrared spectrophotometric sensor is clinically feasible for rapid, bloodless prediction of elevated hs-cTnI in real-world settings. It may have a role in establishing a point-of-care biomarker diagnosis of myocardial infarction and impact triaging patients with suspected [heart attack].

Today's News and Commentary

March 6, 2023 Joel Shalowitz

About Covid-19

CDC: XBB.1.5 Responsible for 90% of New Coronavirus Infections “According to updated estimates from the Centers for Disease Control and Prevention, XBB.1.5 caused nearly 90% of new coronavirus cases this week. That’s up from 85% of cases last week. It’s the only strain showing significant growth.
Coronavirus cases, hospitalizations and deaths are on the decline, signaling that the U.S. has avoided a large seasonal COVID-19 surge like it saw the past two years. The main reason is likely the high level of immunity across the population whether through vaccination, infection or both.
Still, nearly half of U.S. counties are experiencing a “high” level of COVID-19 transmission, according to CDC data.”

Parental Nonadherence to Health Policy Recommendations for Prevention of COVID-19 Transmission Among Children “In this survey study of US parents, one-quarter engaged in misrepresentation or nonadherence regarding PHMs for their children. The most common reason was to preserve parental autonomy. Additional reasons included wanting to resume a normal life for their child and the inability to miss work or other responsibilities, among other reasons.
These results suggest that some PHMs implemented to limit the spread of COVID-19 may have been compromised due to misrepresentation and nonadherence by parents on behalf of their children, contributing to COVID-19–related morbidity and mortality. In addition, some children appear to have received a vaccine that was not fully tested and approved in their age group.”

About health insurance/insurers

Date Set for Restoring Medicaid Benefits in Covid-19 Rule Row “States that ended or modified Medicaid benefits due to a likely defunct HHS rule must restore benefit levels to those that were in effect at the time they were terminated, a federal court said.
Judge Michael P. Shea clarified a Jan. 31 order in which he certified a beneficiary class and told US Health and Human Services Secretary Xavier Becerra to reinstate previous guidance issued under the Families First Coronavirus Response Act.
The guidance prohibited states from kicking people off Medicaid or reducing their benefits in exchange for additional Medicaid money provided by HHS during the pandemic.”

About pharma

OGD sees higher approvals in 2022 “The number of US generic drug approvals rebounded in 2022 after a drop in 2021. In calendar year 2022, the US Food and Drug Administration (FDA) approved or tentatively approved 917 abbreviated new drug applications (ANDAs).
In 2021, FDA approved or tentatively approved 776 ANDAs for generic drugs, down from 948 in 2020 and 1,014 in 2019. The latest figures are part of FDA’s Office of Generic Drugs (OGD) 2022 Annual Report.”

About the public’s health

Rates of congenital syphilis are skyrocketing in the US. Here’s why “Over the past decade, ‘there’s been about a 700% increase in the cases of congenital syphilis in the United States,’ said Dr. Robert McDonald of the US Centers for Disease Control and Prevention’s Division of STD Prevention, Surveillance and Data Management…
Rates of congenital syphilis, meaning the number of cases for every 100,000 live births, are highest in the South and Southwest, in states such as Arizona, New Mexico, Louisiana, Mississippi and Texas, according to a CNN analysis of CDC data.”
The multiple reasons for this surge, especially funding cutbacks, are discussed.

Cardiovascular Risk Factor Prevalence, Treatment, and Control in US Adults Aged 20 to 44 Years, 2009 to March 2020 “In this serial cross-sectional study of 12 924 adults aged 20 to 44 years, there were increases in the prevalence of diabetes (from 3.0% to 4.1%) and obesity (from 32.7% to 40.9%), no improvement in the prevalence of hypertension (from 9.3% to 11.5%), and a decrease in the prevalence of hyperlipidemia (from 40.5% to 36.1%) from 2009-2010 to 2017-2020. Black young adults had the highest rates of hypertension over the study period, and increases in hypertension were observed among Mexican American and other Hispanic adults, while Mexican American adults experienced a significant rise in diabetes. Blood pressure control did not significantly change among young adults treated for hypertension, while glycemic control remained suboptimal throughout the study period.”

About healthcare IT

Teladoc-owned BetterHelp to pay $7.8M to online therapy users for alleged data misuse, per FTC order “ As part of a proposed order announced Thursday, BetterHelp is banned from sharing consumers’ health data, including sensitive information about mental health challenges, with third parties for marketing and ad targeting.
BetterHelp also agreed to pay $7.8 million to consumers to settle charges that it revealed consumers’ sensitive data with third parties for advertising after promising to keep such data private, according to a FTC press release.”

About health technology

FDA warns of false negative results for food allergies after skin test recall “All skin tests doctors commonly use to check for food allergies can provide false negative results, the Food and Drug Administration has concluded — meaning people with potentially life-threatening allergies could mistakenly be told they are not at risk. The tests will now be required to include a warning urging doctors to consider double-checking the test with more accurate approaches.
The FDA's new mandated warning, announced Friday, comes after a recall in December of some skin tests used for testing food allergies.”

Precision medicine company Tempus inks 3rd major pharma deal, securing nearly $1B revenue boost “As part of a multiyear strategic collaboration, Pfizer will tap multiple parts of Tempus' AI platform and its data library to advance clinical discovery.
In the past two years, Tempus has notched partnerships with global pharmaceutical companies to boost its work in drug discovery and precision oncology. The company has an expanded collaboration with GSK to enable the U.K. pharma giant to leverage its AI-enabled patient data platform. GSK recently paid Tempus $70 million upfront for three more years of partnership.
Tempus also inked a partnership with AstraZeneca to use its AI technologies to advance cancer drug development.
These three pharma deals collectively represent approximately $700 million in revenue over the next few years, according to Tempus executives.”

Today's News and Commentary

March 3, 2023 Joel Shalowitz

About Covid-19

Senate Seeks Covid Origins Information Declassification “The Senate voted unanimously Wednesday night to require Director of National Intelligence Avril Haines to declassify information on the origin of Covid-19.
The bill (S. 619), which was passed without objection or a roll-call vote, could put pressure on the Biden administration to voluntarily declassify.”

US public investment in development of mRNA covid-19 vaccines: retrospective cohort study "The US government invested at least $31.9bn to develop, produce, and purchase mRNA covid-19 vaccines, including sizeable investments in the three decades before the pandemic through March 2022.”
Read the article for the sources and timing of funds that account for the total.

Biden pushes for $1.6B funding for pandemic fraud measures “President Joe Biden’s administration is asking Congress to approve more than $1.6 billion to help clean up the mess of fraud against the massive government coronavirus pandemic relief programs.
In a strategy announced Thursday, the administration called for money and more time to prosecute cases, to put into place new ways to prevent identity theft and to help people whose identities were stolen.”

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years “The Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as the third dose of the three-dose primary series for children in this age group. Authorization of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sublineages.”
About health insurance/insurers

After People on Medicaid Die, Some States Aggressively Seek Repayment From Their Estates “Federal law requires all states to have ‘estate recovery programs,’ which seek reimbursements for spending under Medicaid… The recovery efforts collect more than $700 million a year, according to a 2021 report from the Medicaid and CHIP Payment and Access Commission, or MACPAC, an agency that advises Congress.
States have leeway to decide whom to bill and what type of assets to target. Some states collect very little. For example, Hawaii’s Medicaid estate recovery program collected just $31,000 in 2019, according to the federal report.
Iowa, whose population is about twice Hawaii’s, recovered more than $26 million that year, the report said.”

Healthcare billing fraud: 18 recent cases FYI. Notice how many cases involved Medicare/Medicaid.

Bright Health staring down bankruptcy, needs to raise $300M, execs say “Bright Health Group needs to raise about $300 million to avoid bankruptcy after it overdrafted its credit, executives told investors on Wednesday.
Chief Financial Officer Cathy Smith said that the company spent the $350 million available in its revolving credit facility, violating its liquidity covenant with its lenders as it is required to keep at least $200 million in that account. The company did secure a waiver and must address the shortfall by the end of April.”

BCBS Michigan posts $777M loss in 2022 “Blue Cross Blue Shield of Michigan reported a $777 million loss for 2022, driven in part by the ongoing cost of the COVID-19 pandemic and pricing pressures in Medicare Advantage.
In a March 1 news release, the company reported its total revenue was $32.8 billion in 2022, resulting in a net loss of 2.3 percent for the year.
Other factors contributing to the loss were declining investment portfolio values and costs related to the sale of Advantasure, the company's health services arm.”

Humana, Aledade ink 10-year value-based care partnership “Humana has inked a 10-year partnership with Aledade to provide value-based care services to its Medicare Advantage members.
The two companies have a long-term working relationship, and, by the end of 2022, more than 100,000 Humana members were Aledade patients, according to an announcement. Their partnership dates back to 2019 in several states, and, since then, the two have been able to reduce inpatient hospitalizations by 5% and readmissions by 12%.”

Texas' gold card prior authorization rule not worth its weight so far “Texas' physician gold-card rule took effect in October, but providers are not seeing the results they hoped for, the American Medical Association reported March 1.
Under the law, physicians who have a 90 percent prior authorization approval rate over a six-month period on certain services are exempt from prior authorization requirements for those services.
The implementation of the law by the Texas Department of Insurance has been problematic, according to the AMA. The Texas Medical Association has reported a lack of enforcement and liberties taken with the rulemaking that create barriers to qualify for the exemption.”

20 things to know about the fastest growing form of Medicare Advantage “Special needs plans, Medicare Advantage plans for individuals with chronic or disabling conditions, are growing faster than the general MA program.
[The article has]… 20 facts and figures to know about who SNPs serve, how they work and their rapid growth.”

About hospitals and healthcare systems

20 health systems reporting losses in 2022 FYI

Genesis Health System joins MercyOne “MercyOne is a member of Trinity Health, headquartered in Livonia, Michigan. Trinity Health is one of the largest not-for-profit health care systems in the country with 88 hospitals across 26 states. Trinity Health is not affiliated with any Iowa-based entities currently using the name ‘Trinity’ or ‘Trinity Health.’”

UnityPoint Health, Presbyterian Healthcare set sights on 40-plus hospital merger “Des Moines, Iowa-based UnityPoint Health and Albuquerque, New Mexico-based Presbyterian Healthcare Services have pulled back the curtain on plans to merge and form a system with more than 40 hospital facilities across four states.
The nonprofit systems announced Thursday that they have signed a letter of intent ‘to explore the formation of a new healthcare organization.’ The announcement didn’t include a timeline as each system works toward a definitive agreement and regulatory approvals.”

CEOs Are Losing Faith in Their Direct Reports “A new survey indicates that CEO confidence in their own executive-leadership teams has fallen from 74% in the first half of 2021 to about 66% in 2022. More bosses have expressed pessimism about the capabilities of their direct reports, their overall behavior, and their approach to tackling critical issues…
The pattern was consistent across multiple industries, including telecommunications (46%), technology (41%), manufacturing (43%), and health care (42%).”

Early NFP Hospital Medians Show Expected Deterioration; Will Worsen “Not-for-profit hospital operating margins were pressured following a difficult FY22, according to medians compiled by Fitch Ratings for hospitals with an earlier FYE 2022. Audited results show materially weaker profitability and liquidity relative to FY21 due to expense increases and investment market losses.
The decline in operating results are likely to be even more pronounced in our full-year medians later this year when we have financial reporting for all rated hospitals, given the fact that the results of hospitals with later FYEs bore the full brunt of intensifying financial pressures in 2022, including labor inflation and market volatility. Fitch does not expect a rapid financial recovery for most providers, although hospitals under operational pressure will begin to see breakeven results on at least a month-to-month basis at some point in 2023 with revenue growth and expense pressures easing. Nevertheless, margins are not expected to return to pre-pandemic levels for quite some time.”

About pharma

Drugs likely subject to Medicare negotiation, 2026-2028 “In 2026-2028, we estimate that Medicare will negotiate prices for 38 Medicare Part D drugs and 2 Part B drugs. Combined, the 40 products eligible for negotiation in 2026-2028 accounted for $67.4 billion in gross Medicare spending in 2020. Part D drugs eligible for negotiation in 2026-2028 include 7 inhalers, 8 antidiabetics, 5 kinase inhibitors, and 3 oral anticoagulants. In all but 5 cases, high-spend drugs ineligible for negotiation were disqualified because of generic or biosimilar competition.”

WE Brands in Motion Health Study: Corporate Reputation Is Leading Factor in Prescribing Decisions “WE Communications (WE) released its latest Brands in Motion global report, ‘Healthy Reputation: More Than Medicine.’ The data reveals that, outside a medication’s functional characteristics, healthcare professionals ranked corporate reputation as the foremost influencing factor when it comes to making prescribing decisions.”

ICER dials up recommended price range for Eisai's Leqembi—but still calls for sizable discount “Influential U.S. drug pricing research group the Institute for Clinical and Economic Review (ICER) has updated its assessment of Eisai’s new Alzheimer's disease drug Leqembi. In the wake of a rival drug's rejection, the agency supports a slightly higher price tag for the Eisai medicine than it had previously proposed.
Leqembi, also known as lecanemab, should cost between $8,900 to $21,500 per year to be considered cost effective, ICER said Wednesday.
The new recommended price means Eisai should take 19% to 66% off of Leqembi’s current list price of $26,500, ICER contends.”

Financial Impact of Metabolic Surgery on Prescription Diabetes Medications in Michigan “The mean decrease in diabetes prescription payments made by the insurance provider was $4133 per patient ($6736 for gastric bypass and $3409 for sleeve gastrectomy) in the 360 days postsurgery compared with the 360 days presurgery. Meanwhile, the price-standardized 30-day payment for surgery was $14 832. Given that 34% of all patients undergoing metabolic surgery in Michigan have diabetes and a total of 54 454 metabolic procedures were performed between 2015 and 2021, it is estimated that insurance providers in Michigan saved more than $76.5 million on diabetes medications in the 360 days following surgery.”

Walgreens cuts its stake in Option Care Health “Walgreens Boots Alliance is selling off a chunk of its stake in Option Care Health, an infusion services company that Walgreens first purchased more than 15 years ago.
The Deerfield-based pharmacy giant said it sold about 15.5 million Option Care shares for $30.75 per share. With the sale, Walgreens’ ownership stake in Bannockburn-based Option Care falls from 14% to 6%.
The funds will be used to pay down Walgreens’ debt, some of which was incurred during recent deals to invest or acquire health care delivery businesses.”

About the public’s health

Colorectal cancer statistics, 2023 The most alarming finding was: “…the proportion of cases among those younger than 55 years increased from 11% in 1995 to 20% in 2019.”

More than half of the world will be overweight or obese by 2035 - report “More than half of the world's population will be overweight or obese by 2035 without significant action, according to a new report.
The World Obesity Federation's 2023 atlas predicts that 51% of the world, or more than 4 billion people, will be obese or overweight within the next 12 years.
Rates of obesity are rising particularly quickly among children and in lower income countries, the report found.”

Walgreens won’t sell abortion pills in 20 states after warning “Walgreens Boots Alliance Inc. will not sell abortion pills in 20 states after warnings by Republican attorneys general of legal action, a decision that limits the medication’s availability in many places where access to the procedure is already restricted.
The company won’t dispense mifepristone in those states, Fraser Engerman, a company spokesman, said in an emailed statement to Bloomberg News.”

About healthcare IT

FACT SHEET: Biden-⁠Harris Administration Announces National Cybersecurity Strategy The document is more aspirational than operational.

Most Primary Care Telehealth Visits Unlikely to Need In-Person Follow-Up “Key Findings
—More than 60% of the time, primary care telehealth visits did not have an in-person follow-up visit in the same specialty within 90 days.
—Kids more frequently had an in-person office visit following a telehealth visit; however, more than half of the time (54%), kids did not have an in-person follow-up.
—55% of patients with Medicare or Medicaid insurance coverage did not have an in-person follow-up after a primary care telehealth visit.”

Best Buy's $400M remote patient monitoring company partners with Geisinger, Mount Sinai, NYU Langone Health “Best Buy has partnered with five of the 10 largest U.S. health systems on remote patient monitoring, according to a March 2 earnings call.
Its subsidiary, Current Health, now works with Danville, Pa.-based Geisinger, New York City-based Mount Sinai Health System and New York City-based NYU Langone Health…
The company's platform combines remote patient monitoring, telehealth, patient engagement and a full support model…,
Best Buy acquired Current Health for $400 million in 2021, part of its continued push into providing technology for remote patient monitoring.”

About healthcare personnel

Oak Street posts almost $510M loss as it continues clinic ramp-up Chicago-based Oak Street Health, which CVS Health is planning to acquire, reported a net loss of $509.7 million in 2022 as it continued to expand the number of centers it operates…
The 2022 loss compared with a net loss of $414.6 million in 2021. Revenues increased by 51 percent to total $2.16 billion.”

About health technology

Large language models generate functional protein sequences across diverse families “Deep-learning language models have shown promise in various biotechnological applications, including protein design and engineering. Here we describe ProGen, a language model that can generate protein sequences with a predictable function across large protein families, akin to generating grammatically and semantically correct natural language sentences on diverse topics. The model was trained on 280 million protein sequences from >19,000 families and is augmented with control tags specifying protein properties. ProGen can be further fine-tuned to curated sequences and tags to improve controllable generation performance of proteins from families with sufficient homologous samples.”

Today's News and Commentary

March 1, 2023 Joel Shalowitz

About Covid-19

Still no consensus on Covid’s origins, White House says “The U.S. government still has not reached a consensus on how the coronavirus pandemic started, National Security Council spokesperson John Kirby told reporters Monday — despite news reports that the Energy Department has concluded the virus most likely leaked from a lab in China.”

About health insurance/insurers

DELIVERING LOWER COSTS FOR PATIENTS AND TAXPAYERS THROUGH SITE-NEUTRAL PAYMENT REFORM An excellent review of this topic from the BCBSA that hits all the major topic points. The “bottom line” is a $471B savings over 10 years just for the federal government.

Outpatient visits billed at increasingly higher levels: implications for health costs “We examine the distribution of code levels in physician offices, urgent care centers, and emergency departments over time, for all evaluation and management claims and for specific diagnoses. This analysis only includes evaluation and management claims and does not include additional visit-associated bills such as laboratory tests or other services.
Over the 18-year period of our analysis, we find that claims across all three sites of care trended towards higher level codes, even among specific, common diagnoses like urinary tract infections and headaches. The average age of this population stayed consistent over time. However, we do not assess whether health status worsened with time, so we are not able to assess whether increases in billed complexity represent actual changes in clinical characteristics.”

CMS' most successful alternative payment models “CMS has launched more than 50 savings model programs since the agency's innovation center was created in 2010, according to the Center for Medicaid and Medicare Innovation's 2022 Report to Congress.
Though many models have been tested, only a few have clearly emerged as successful at reducing costs and improving outcomes, according to the report.
Six models led to statistically significant savings:
—Pioneer ACO Model
—ACO Investment Model
—Medicare Prior Authorization Model: Repetitive Scheduled Non-Emergent Ambulance Transport
—Home Health Value-Based Purchasing Model
—Maryland All-Payer Model
—Medicare Care Choices Model
Two models, the Pioneer ACO Model and the Medicare Care Choices Model, also showed significant improvements in care quality, according to the report.”

Association of Evaluation and Management Payment Policy Changes With Medicare Payment to Physicians by Specialty “In this retrospective observational study that included 180 624 US office-based physicians, the difference in the median total Medicare payments received by primary care physicians compared with specialists was $40 259.8 in July-December 2020 and $39 434.7 in July-December 2021 (difference, −$825.1 [2.0% decrease]).
Meaning The 2021 E/M payment policy changes were associated with changes in Medicare payments by specialty, although the payment gap between primary care physicians and specialists decreased only modestly.
See, also, the accompanying editorial: Payment, Priorities, and Primary Care: Can Cognitive Work Be Properly Valued?

Health Insurer Financial Performance in 2021 "We find that, by the end of 2021, gross margins per enrollee had returned to pre-pandemic levels in the Medicare Advantage market, while gross margins in the individual and group markets were lower than pre-pandemic levels and Medicaid margins were higher than pre-pandemic levels. Medicare Advantage plans have far higher per person gross margins—more than double those seen in other markets in 2021.”
As usual with the KFF reports, the graphics tell most of the story.

GAO: MEDICARE ADVANTAGE: Plans Generally Offered Some Supplemental Benefits, but CMS Has Limited Data on Utilization “The 3,893 MA plans reviewed had a median net projected cost for supplemental benefits of about $27 per enrollee per month in 2022— approximately $6.4 billion in total—according to our analysis of the CMS bid pricing data. The net projected costs reflect the amounts that plans expected to pay for supplemental benefits and do not include cost-sharing (such as copayments) that plans may require of enrollees.”

UPMC, head of cardiothoracic surgery will pay $8.5M to feds to settle lawsuit “UPMC, a renowned cardiothoracic surgeon there and a physicians group will pay the federal government $8.5 million to settle a lawsuit accusing them of knowingly submitting hundreds of false claims to Medicare, failing to follow medical standards for surgery and knowingly placing patients at risk.
The U.S. Attorney’s Office filed a lawsuit against UPMC, Dr. James Luketich and University of Pittsburgh Physicians in September 2021 alleging Luketich was regularly scheduling multiple complex surgeries at the same time, forcing him to move between operating rooms and sometimes hospitals, while requiring patients to stay under additional hours of anesthesia.
In one case, a patient lost parts of a hand and another lost a lower leg as a result, the government said.”

BCBS Louisiana acquisition cost Elevance Health $2.5B “Elevance Health agreed to pay $2.5 billion for Blue Cross and Blue Shield of Louisiana, its first state Blue Cross Blue Shield acquisition in over 15 years… According to documents acquired by the outlet, additional conditions could raise the value of the transaction by $1 million.
BCBS Louisiana, a nonprofit, will use the funds from the acquisition to establish a foundation to address health equity and provide payouts to many of its members. The insurer will become a for-profit subsidiary of Elevance.”

About hospitals and healthcare systems

National Hospital Flash Report February 2023 “Key Takeaways

1. Hospitals get off to smoother start to the year compared to 2022.

The start of 2022 coincided with the Omicron COVID surge, putting hospitals in a difficult financial position to start the year.
With no spike in COVID cases in January 2023, hospitals entered the year on more stable footing, but continued to experience the same challenges that made 2022 the worst financial year since the start of the pandemic. According to Kaufman Hall experts, while the start to 2023 was better than 2022, beginning-of-the-year performance still lagged behind 2021 and 2020.

2. Margins are down slightly from the end of 2022.

Hospital operating margins in January 2023 were down slightly compared to December 2022. One factor that contributed to the dip in performance, according to Kaufman Hall experts, is the normal trend of hospitals making purchases for the year in January.

3. Hospitals continue to experience lower volumes and higher expenses.

Volumes, emergency department visits, discharges and total revenues were down in January 2023 compared to December 2022. Expenses—particularly related to labor—increased over the same time period; though, not as fast as in previous months.

4. 2023 could represent a new normal for hospitals.

Hospitals must continue to explore how to treat lower-acuity patients in novel settings as patient volumes continue to shift to outpatient locations. Furthermore, with future COVID surges likely and difficult financial months ahead, managing cash effectively will be critical to weathering the storm.”

AdventHealth reports almost $838M loss as investment returns tank The article highlights the importance to hospitals of investment income that offsets operating losses.

Rural Hospitals Are Shuttering Their Maternity Units “From 2015 to 2019, there were at least 89 obstetric unit closures in rural hospitals across the country. By 2020, about half of rural community hospitals did not provide obstetrics care, according to the American Hospital Association.
In the past year, the closures appear to have accelerated, as hospitals from Maine to California have jettisoned maternity units, mostly in rural areas where the population has dwindled and the number of births has declined.
A study of hospital administrators carried out before the pandemic found that 20 percent of them said they did not expect to be providing labor and delivery services in five years’ time.”

About pharma

Lilly to cut some insulin prices by 70%, bolster cost cap “Eli Lilly on Wednesday announced price reductions of 70% for its most commonly prescribed insulins, and said it is also making improvements to a programme that caps out-of-pocket insulin costs for patients at $35 a month…
The change, which Eli Lilly said takes effect immediately, puts the drugmaker in line with a provision in the US Inflation Reduction Act, which last month imposed a $35 monthly cap on the out-of-pocket cost of insulin for seniors enrolled in Medicare.
As part of the measures announced Wednesday, Eli Lilly said the list prices for Humalog (insulin lispro) and Humulin (insulin human) will be slashed by 70% starting in the fourth quarter of 2023. Humalog currently carries a list price of $530 for a five-pack of injection pens and $274 for a vial, although Eli Lilly said most people with commercial insurance and Medicare pay no more than $95 a month.”

Distributors Win Milestone Trial Over Individual Opioid Abuse “Pharmaceutical wholesalers aren't responsible for harms to individuals whose family members abused narcotics, a Georgia jury decided Wednesday, capping off a first-of-its-kind trial that threatened to open a massive new front in opioid litigation despite multibillion-dollar settlements covering harms suffered by communities.”

The albuterol shortage is about to get worse “Children’s hospitals across the country lost a supplier of a commonrespiratory medicine with the sudden shutdown of an Illinois manufacturing plant last week, which specialists warned will prolong shortages of an important treatment for kids with RSV and asthma who show up in emergency rooms.
Akorn, a company that has struggled under bankruptcy for two years and had been the subject of Food and Drug Administration enforcement actions, shut down its U.S. operations on Thursday, including manufacturing facilities in Illinois, New Jersey and New York.”

Jazz Pharmaceuticals Loses Narcolepsy Drug Patent Appeal “A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies (REMS) distribution system for its blockbuster narcolepsy therapy Xyrem (oxybate).”
For more background on the case, see: A Drug Company Exploited a Safety Requirement to Make Money

About the public’s health

FDA panel narrowly backs Pfizer RSV vaccine for older adults “The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer’s data showed the vaccine was safe and effective against the respiratory virus for people 60 and older. One panelist abstained from voting. The recommendation is non-binding and the FDA will make its own decision on the vaccine in the coming months.
The positive vote came despite concerns about rare potential reactions and questions about how the vaccine fared in people who face the greatest risks from RSV. Pfizer’s shot was more than 85% effective at preventing severe disease in a company study, but panelists noted there were few people with underlying health problems.”

Governor Reeves Signs Bill Banning Gender Reassignment Procedures for Children “ Governor Tate Reeves today signed House Bill 1125 – the Regulate Experimental Adolescent Procedures Act – which bans gender reassignment procedures for Mississippians under the age of 18.”

One type of artificial sweetener may increase heart attack risk, preliminary study says “The sweetener erythritol, which is becoming increasingly popular in snack bars and low-sugar ice cream substitutes, may increase the risk of heart attacks and strokes, according to a paper published Monday in the journal Nature Medicine.
Outside experts who reviewed the findings emphasized that more evidence is needed, with some raising concerns that the results of the study could be due to other factors that make it appear the sweetener causes risks when it does not.”

About healthcare IT

Healthcare Most Hit by Ransomware Last Year, FBI Finds “The FBI's Internet Complaint Center last year received 870 complaints that ‘indicated organizations belonging to a critical infrastructure sector were victims of a ransomware attack,’ said David Scott, deputy assistant director of the FBI's Cyber Division…
Critical manufacturing and the government, including schools, followed healthcare as the most-attacked sectors…”

Epic, Press Ganey to integrate patient experience data into MyChart “Epic Systems has partnered with consumer experience company Press Ganey to integrate patient experience data into MyChart.
Under the agreement, Press Ganey's data and insights will be integrated into Epic's MyChart patient portal and Cheers CRM, according to a March 1 news release from Press Ganey. The initial integrations will be available later this year.”

HHS Announces New Divisions Within the Office for Civil Rights to Better Address Growing Need of Enforcement in Recent Years Because the caseload has increased 69% between 2017 and 2022, the “U.S. Department of Health and Human Services, through the Office for Civil Rights (OCR), announced the formation of a new Enforcement Division, Policy Division, and Strategic Planning Division.” The announcement explains how each will work.

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends An excellent legal guide.

Predicting the Survival of Patients With Cancer From Their Initial Oncology Consultation Document Using Natural Language Processing “These findings suggest that models performed comparably with or better than previous models predicting cancer survival and that they may be able to predict survival using readily available data without focusing on 1 cancer type.”

About healthcare personnel

Two articles bout physician management companies:
Privia Health nets $17.8M in profit in Q4 as it eyes national expansion of provider network “Physician enablement company Privia Health turned a profit in the fourth quarter of 2022 and is forecasting strong growth this year as it eyes geographic expansion.
The company, which went public in May 2021, brought in $17.8 million in net income in the fourth quarter, or 14 cents per diluted share, compared to a net loss of $12 million, or a loss of 11 cents per share, in the same quarter a year ago.”
Aledade notches another acquisition, adds 450 practices to growing network as the primary care market heats up “As investment in value-based primary care heats up, Aledade picked up value-based care analytics company Curia to build out its tech capabilities.
Aledade did not disclose financial details of the transaction.
It marks the company's second M&A deal after its tuck-in acquisition of Iris Healthcare a year ago.”

Women’s Experiences with Provider Communication and Interactions in Health Care Settings: Findings from the 2022 KFF Women’s Health Survey “Summary of Findings

· Among women ages 18-64 who have seen a health care provider in the past two years:

o Twenty-nine percent report that their doctor had dismissed their concerns in that time period, 15% reported that a provider did not believe they were telling the truth, 19% say their doctor assumed something about them without asking, and 13% say that a provider suggested they were personally to blame for a health problem. A higher share of women (38%) than men (32%) report having had at least one of these negative experiences with a health care provider.

o One in ten (9%) women ages 18-64 say that they have experienced discrimination because of their age, gender, race, sexual orientation, religion, or some other personal characteristic during a health care visit in the past two years.

o Few women report being asked about social and economic factors that may influence health. While 58% report that in the past two years their provider asked them about what kind of work they do, far fewer report having been asked about their housing situation (30%), their ability to afford food (20%), or access to reliable transportation (20%). Women with Medicaid and those with low incomes are more likely to say they have been asked about these last three indicators than women with private insurance and those with higher incomes.

· Communication is an important component of health care quality; however, 21% of women (including 38% of uninsured women), say it is difficult to find a doctor who explains things in a way that is easy to understand.

· Just over one-third (35%) of women ages 40-64 say their health care provider ever talked to them about what to expect in menopause.”

About health technology

Organoid intelligence (OI): the new frontier in biocomputing and intelligence-in-a-dish
Fascinating potential, though it reminds me of the PK Dick novella The Minority Report.
“Key points

Biological computing (or biocomputing) could be faster, more efficient, and more powerful than silicon-based computing and AI, and only require a fraction of the energy.
‘Organoid intelligence’ (OI) describes an emerging multidisciplinary field working to develop biological computing using 3D cultures of human brain cells (brain organoids) and brain-machine interface technologies.
OI requires scaling up current brain organoids into complex, durable 3D structures enriched with cells and genes associated with learning, and connecting these to next-generation input and output devices and AI/machine learning systems.
OI requires new models, algorithms, and interface technologies to communicate with brain organoids, understand how they learn and compute, and process and store the massive amounts of data they will generate.
OI research could also improve our understanding of brain development, learning, and memory, potentially helping to find treatments for neurological disorders such as dementia.
Ensuring OI develops in an ethically and socially responsive manner requires an ‘embedded ethics’ approach where interdisciplinary and representative teams of ethicists, researchers, and members of the public identify, discuss, and analyze ethical issues and feed these back to inform future research and work.”

About healthcare finance

Humana seeks up to $1.25B with bond issues “Humana will issue up to $1.25 billion in bonds to pay off debt and finance operations, the company announced Tuesday. The insurer plans to use the proceeds to pay off a $500 million loan from 2021 to offset the cost of its deal to acquire home care company Kindred at Home, and for general corporate purposes.”

CD&R, Humana-Backed Gentiva Inks $710 Million Hospice Deal “Gentiva, a hospice company backed by Clayton Dubilier & Rice and Humana Inc., has agreed to acquire a business from not-for-profit health-care system ProMedica, Gentiva’s chief executive officer said.
Gentiva’s deal for hospice and home-care assets from ProMedica’s Heartland is valued at $710 million, including debt, according to people familiar with the matter, who asked not to be identified because the information is private.”

Today's News and Commentary

February 27, 2023 Joel Shalowitz

About Covid-19

Lab Leak Most Likely Origin of Covid-19 Pandemic, Energy Department Now Says “The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress…
The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.”

Not enough data to support multiple annual COVID boosters, U.S. CDC advisers say “An expert advisory group to the US Centers for Disease Control and Prevention (CDC) said there is not sufficient evidence to recommend more than one COVID-19 booster shot a year for older people and those with weakened immune systems…”

First combination home test for flu and covid cleared by the FDA “The Food and Drug Administration on Friday authorized the first combination test for the flu and the coronavirus that is fully performed at home, giving consumers a convenient way to determine which pathogen may be causing their respiratory illnesses.
The agency granted emergency use authorization to the Lucira Covid-19 & Flu Test, which provides results in about 30 minutes from samples collected by a nasal swab.”

About health insurance/insurers

IDRs to resume certain payment determinations under No Surprises Act “Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.”

About pharma

Democratic-led U.S. states challenge restrictions on abortion pill “Twelve Democratic-led states have sued the U.S. Food and Drug Administration to challenge certain federal restrictions imposed on the distribution of the abortion pill mifepristone, saying those limits are not supported by evidence.
The lawsuit, led by Washington state and Oregon, was filed on Thursday in federal court in Yakima, Washington and aims to expand access to mifepristone by allowing it to be prescribed and dispensed by any doctor or pharmacy, like most drugs. Currently, doctors who prescribe mifepristone, and pharmacies that dispense it, must obtain a special certification.
Meanwhile, a separate lawsuit by anti-abortion activists that seeks to end access to the drug is proceeding in Texas.”

How 5 drugmakers fared in 2022 FYI

About healthcare IT

DEA announces proposed rules to make telemedicine permanently flexible, safeguarded “The Drug Enforcement Administration (DEA) announced on Friday that it is proposing rules to make many flexibilities for telemedicine that were established amid the COVID-19 pandemic permanent, with certain safeguards.
The DEA said in a release that the rule will give patients access to virtual therapies beyond the end of the COVID-19 public health emergency, which is scheduled to conclude in May.”

Major coalition of health groups aims to combat health misinformation “A new industrywide coalition of healthcare groups aims to combat persistent problems with misinformation, a lingering problem exacerbated by the COVID-19 pandemic.
The Coalition for Trust in Health & Science is expected to formally launch on March 2. The coalition will contain more than 50 groups that run the gamut from payers, providers to drug manufacturers.”

About health technology

Wearable Fitness Trackers May Interfere With Cardiac Devices “Wearable electronic devices such as smart watches, worn by consumers to monitor their health, could interfere with the correct working of cardiac implantable electronic devices (CIEDs), posing serious health risks to these patients.
Researchers at the University of Utah, in Salt Lake City, found that certain fitness trackers, such as smart watches, smart rings and smart scales, that emit an electrical current have the potential to essentially confuse CIEDs, devices including pacemakers, implantable cardioverter defibrillators, (ICDs) and cardiac resynchronization therapy devices, (CRTs), causing them to stop working.
Smart watches generated the highest level of interference; smart scales and smart rings generated lower levels.”

FDA Clears Spectrum’s Saliva Collection Device “Spectrum Solutions has received 510(k) marketing clearance from the FDA for a saliva collection device that keeps microbial nuclear acids stable for weeks at room temperature.
The device uses the company’s patented nucleic acid preservation technology and neutralizes viruses within 10 seconds of collection to mitigate the risk of exposure.”

Today's News and Commentary

February 24, 2023 Joel Shalowitz

About Covid-19

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license “In Moderna's earnings release Thursday, the company said it recently paid the National Institute of Allergy and Infectious Diseases (NIAID) a $400 million ‘catch-up payment’ under a new royalty-bearing license agreement between the parties.
The payment is part of a license agreement between Moderna and NIAID inked late last year. With the deal, Moderna is paying the U.S. government to access ‘certain patent rights concerning stabilizing prefusion coronavirus spike proteins,’ Moderna Chief Financial Officer Jamie Mock said on a conference call Thursday.
Going forward, Moderna agreed to pay NIAID “‘ow single-digit royalties’ on COVID-19 vaccine sales, Mock added.”

About health insurance/insurers

Evaluation of Potentially Avoidable Acute Care Utilization Among Patients Insured by Medicare Advantage vs Traditional Medicare “This cross-sectional study of more than 10 million beneficiaries found that patients who experienced an ambulatory care−sensitive condition and were covered by Medicare Advantage were less likely to be hospitalized and more likely to be discharged directly from the ED or have an observation stay than were patients with traditional Medicare.”

How to Create a Better Consumer Market for U.S. Health Care Price transparency alone will not reduce patient costs. Given that not all services are “shoppable,”the authors recommend these measures:
1. Specify standardized services. Medical care providers should be forced to specify their prices for a list of standardized, consumer-focused bundles of services tied to full episodes of clinical interventions.
2. Make provider participation mandatory.
All providers should be required to participate in this bundled pricing system to ensure the market is populated with multiple options for patients.
3. Make the same prices available to everyone. The prices posted for these services should be “walk up” prices available to all patients, irrespective of their insurance status.
4. Ensure consumers reap the benefits. For price competition to work as planned, consumers must appreciate that price shopping can be financially rewarding. Currently, insurance designs stifle incentives for consumers by making them largely price insensitive. After they have already paid the required copay and deductible, the insurer typically pays the full cost, so the consumer is not concerned about shopping for the best price.”

About pharma

Characteristics of Prior Authorization [PA] Policies for New Drugs in Medicare Part D “In this cross-sectional study of drugs approved 2013 to 2017, 40% had PA criteria that placed conditions on formulary coverage beyond the FDA indication. Specific criteria varied considerably between insurers, which may increase the administrative burden on clinicians and beneficiaries seeking to consider PA policies when choosing among Part D plans or switching between insurers. More consistency in how plans implement PA in Part D could improve the experiences of patients and clinicians.”

Novartis to pay $30 mln to health plans, consumers over Exforge antitrust claims “Swiss drugmaker Novartis AG has agreed to pay $30 million to settle claims by health plans and consumers that it schemed to delay the U.S. launch of generic competition for its Exforge hypertension drug…
The deal is part of a broader $245 million settlement to end the entire litigation, including claims by drug wholesalers and retailers, which Novartis announced in December. The drugmaker at the time did not say how the money would be broken down.”

About the public’s health

Norovirus spurs rise in ED visits “Norovirus outbreaks have emerged across the U.S., U.K. and Canada in recent weeks, as cold weather brings people into closer contact indoors. The CDC tracks norovirus outbreaks across 14 states, though this data has not been updated since early January. In the week ending Jan. 2, there were 25 outbreaks, up from 14 the same period a year prior.”
Comment: Even though Covid-19 infections are waning, this outbreak provides the opportunity to make sure hand washing is still routine.

Estimates and Projections of the Global Economic Cost of 29 Cancers in 204 Countries and Territories From 2020 to 2050 “The estimated global economic cost of cancers from 2020 to 2050 is $25.2 trillion in international dollars (at constant 2017 prices), equivalent to an annual tax of 0.55% on global gross domestic product. The 5 cancers with the highest economic costs are tracheal, bronchus, and lung cancer (15.4%); colon and rectum cancer (10.9%); breast cancer (7.7%); liver cancer (6.5%); and leukemia (6.3%). China and the US face the largest economic costs of cancers in absolute terms, accounting for 24.1% and 20.8% of the total global burden, respectively. Although 75.1% of cancer deaths occur in low- and middle-income countries, their share of the economic cost of cancers is lower at 49.5%. The relative contribution of treatment costs to the total economic cost of cancers is greater in high-income countries than in low-income countries.”

Heart Attack Deaths Fell for Americans Over Past 20 Years “Age-adjusted rates of heart attack fell by an average of over 4% per year across all racial groups over the two decades.
In 1999, there were about 87 deaths from heart attack per 100,000 people. By 2020, there were 38 deaths per 100,000 people.
Black Americans still had the highest death rates from heart attack, with 104 deaths per 100,000 people in 1999 and 46 deaths per 100,000 in 2020. Death rates from heart attack were lowest among Asians and Pacific Islanders.
It's difficult to determine whether the decline is due to fewer heart attacks or better survival rates because of new diagnostic strategies and treatment options, according to the study authors.”

Americans do not believe the country is ready for another pandemic “Only three in ten (28%) Americans think that the country is adequately prepared to deal with another pandemic.
Just 41% say they trust the information on health topics they get from their state’s governor either a great deal or a fair amount.”
The entire survey is short but has lots of other good information. For example: “Americans view opioids, obesity, and guns as the main threats to public health at the moment. Yet, some leading causes of death like cancer or auto fatalities are further down the list.
Partisanship drives some of the attitudes about leading risks, with Republicans focused on opioids and obesity, while Democrats are more worried about gun deaths.”

About healthcare IT

CDC Foundation Convening Aims to Accelerate Public Health Data Modernization Through Public Private Partnerships “On February 27 and 28, 2023, the CDC Foundation will convene a joint event with the Centers for Disease Control and Prevention (CDC) and the National Coordinator for Health Information Technology (ONC) with the objective to accelerate public health data modernization through public private partnerships.
Addressing health challenges requires bringing together cross-sector groups, and the CDC Foundation's CDC-ONC Industry Days event will inform non-government organizations about CDC's and ONC's plans for modernizing public health data and information systems. The event also will provide both virtual and in-person attendees with opportunities to discuss their services with CDC and ONC staff.”

CommonSpirit Health a model for social determinants data sharing via EHRs: ONC “Chicago-based CommonSpirit Health has robust data sharing and collection to address social determinants of health in the communities it serves, ONC said in a new report.
The health system's Connected Community Network tech platform makes referrals, helps coordinate care and tracks outcomes, integrating social care into everyday healthcare. Its Total Health Roadmap is a universal social needs screening and referral program for primary care patients. Its Homeless Health Initiative uses data sharing to address homelessness. And its Social Needs Analytics platform analyzes EHR data to identify areas for investment to counter injustices.”
And in a related article:
Accuracy of Electronic Health Record Food Insecurity, Housing Instability, and Financial Strain Screening in Adult Primary Care “Commonly used EHR-based social screening questionnaires underidentified patients with housing instability and financial strain compared with single-domain screening tools. This suggests that the primary goal of screening may not be achieved for these 2 risks. In contrast, EHR-based food insecurity screening was accurate.”

60% of Americans Would Be Uncomfortable With Provider Relying on AI in Their Own Health Care “Six-in-ten U.S. adults say they would feel uncomfortable if their own health care provider relied on artificial intelligence to do things like diagnose disease and recommend treatments; a significantly smaller share (39%) say they would feel comfortable with this.
One factor in these views: A majority of the public is unconvinced that the use of AI in health and medicine would improve health outcomes.”

The Public’s Use of Health Apps and Wearables Has Increased in Recent Years. But Digital Health Still Has Room to Grow Highlights: “The use of health apps has grown by 6 percentage points since December 2018, while wearables usage has grown by 8 points, per Morning Consult data.
Respondents said exercise or heart rate monitoring was the primary reason for using a health app.
Adults who don’t use wearables said cost was the primary reason.”

About healthcare personnel

The Health of US Primary Care: A Baseline Scorecard Tracking Support for High-Quality Primary Care “ABSTRACT: The 2021 National Academies of Sciences, Engineering, and Medicine (NASEM) report Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care proposed the development of a scorecard to better monitor and ensure accountability for progress toward high-quality primary care in the United States. This first national primary care scorecard finds a chronic lack of adequate support for the implementation of high- quality primary care in the United States across all measures, although performance varies across states. The scorecard finds:

Financing: The United States is systemically underinvesting in primary care.
Workforce: The primary care physician workforce is shrinking and gaps in access to care
appear to be growing.
Access: The percentage of adults reporting they do not have a usual source of care is increasing.
Training: Too few physicians are being trained in community settings, where most primary care takes place.
Research: There are few federal funding opportunities for primary care research, with only 0.2% of National Institutes of Health funding allocated to primary care.

Given declining life expectancy, racial and ethnic health disparities, the current epidemic of mental health needs, the ongoing COVID-19 pandemic, and other nationwide issues that primary care can help address, these findings represent an urgent call to policymakers and other stakeholders. It is time to accelerate adoption of policies that will demonstrably increase investment in high-quality primary care, create a robust primary care workforce, and enable analysis and learning around the impact of primary care.”

Advancing Shared Decision Making among Older Adults with Serious Health Conditions ”In keeping with its mission to advance cost transparency, FAIR Health has led grant-funded initiatives that have resulted in the addition of shared decision-making tools for various health conditions, educational content and resources to its free, national consumer website fairhealthconsumer.org (FAIR Health Consumer). The tools combine clinical information from EBSCO’s OptionGridTM decision aids and cost data from FAIR Health’s private healthcare claims database comprising over 40 billion claim records from 2002 to the present.”

Today's News and Commentary

February 23, 2023 Joel Shalowitz

About Covid-19

As commercial COVID pivot looms, Moderna logs $2.8B in demand-related expenses “For all of 2022, the mRNA specialist logged a $1.3 billion charge for inventory write-downs, plus $725 million for contract cancelations. Moderna paid another $776 million for unused manufacturing capacity and CDMO charges, representing total expenses tied to slouching demand of around $2.8 billion.
All told, Moderna reported total 2022 sales costs of $5.4 billion, representing 29% of the company’s $18.4 billion that its roster of COVID shots and boosters brought home for the year. Aside from third-party royalty costs of $1.1 billion—plus other expenses related to activities like actually producing the shot—Moderna credited the charges to ‘overall lower demand’ for its vaccines ‘in particular from low-income countries.’ Moderna also cited a shift in demand to the company’s Omicron-busting bivalent boosters, alongside costs ‘associated with surplus production capacity.’”

About health insurance/insurers

Humana to Exit Employer Group Commercial Medical Products Business “Humana Inc. today announced that it will be exiting the Employer Group Commercial Medical Products business, which includes all fully insured, self-funded and Federal Employee Health Benefit medical plans, as well as associated wellness and rewards programs. No other Humana health plan offerings are materially affected. The company remains committed to the long-term growth of its core Insurance lines of business, including Medicare Advantage, Group Medicare, Medicare Supplement, Medicare Prescription Drug Plans, Medicaid, Military and Specialty (Dental, Vision, Life, etc.), as well as its CenterWell healthcare services business.
Following a strategic review, the company determined that the Employer Group Commercial Medical Products business was no longer positioned to sustainably meet the needs of commercial members over the long term or support the company’s long-term strategic plans. The exit from this line of business will be phased over the next 18 to 24 months. The company is committed to ensuring a smooth transition of services for members and commercial customers.”

U.S. Medicare says no change to Alzheimer's drug restrictions “The U.S. government health plan for people over the age of 65 on Wednesday said it would not reconsider strict coverage limits put in place last year for new Alzheimer’s treatments, rejecting a request from the Alzheimer’s Association.
The Centers for Medicare and Medicaid Services (CMS) reaffirmed its policy allowing coverage for drugs designed to clear amyloid plaques from the brains of Alzheimer’s patients only if a medication is approved under the Food and Drug Administration’s standard review process, not under its accelerated review program.
The agency said it would also continue to require a registry to collect evidence of patient outcomes to reflect ‘real-world’ care.”

About hospitals and healthcare systems

Costly discharge delays highlight need for more downstream care options, New York group's analysis shows “Rampant discharge delays last spring cost New York hospitals an average of $168,000 per inpatient case and $18,000 per day in the emergency department, much of which was not reimbursed by payers, according to hospital data from the Healthcare Association of New York State (HANYS).
The data collection pilot, published Tuesday, pulled information from 52 New York hospitals from April 1 to June 30, 2022.
Among these, HANYS found 1,115 patients who “for circumstances largely outside hospitals’ control” couldn’t be discharged from the ED for at least four days or from an inpatient unit for 14 days. These patients collectively represented about 60,000 days of ‘avoidable’ delays, according to the pilot.”
This problem has national scope.

About pharma

Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval[AA] “Among 5 oncology indications, 26.1% of eligible treatment initiations involved an AA indication subsequently withdrawn due to lack of benefit. An expected trade-off exists between expediting access to promising cancer drugs and withdrawal of some indications. Given the growth of withdrawals due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is critical to balance early access against population-level exposure to cancer therapies with no benefit over standard of care.”

Moderna teams up with ElevateBio in mRNA gene editing pact “Moderna and ElevateBio's Life Edit Therapeutics on Wednesday announced a partnership to co-develop in vivo mRNA gene editing therapies using the latter's "large and diverse" library of base editors and RNA-guided nucleases (RGNs). Financial specifics about the multi-target collaboration were not disclosed, but the companies said the focus will be on creating potentially curative therapies for the ‘most challenging’ rare genetic and other diseases.”

HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules “The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to address issues such as patient labeling, conduct of clinical trials and drug compounding.
On 22 February, HHS published its semiannual regulatory agenda, which included a number of rules either under development or set to be finalized by FDA, as well as a timetable for expected completion. Notably, several of the rules, including a rule on medication guides, have been listed in the regulatory agenda for multiple years.”

About the public’s health

Flu vaccine was 68% effective at preventing hospitalization in children but less protective for seniors this season “The flu vaccine has been 68% effective at preventing hospitalizations in children and 35% effective at preventing hospitalization in seniors this season, according to preliminary CDC data.
Dr. Jose Romero, head of the National Center for Immunization and Respiratory Disease, said flu cases and hospitalizations are declining but that the U.S. could see a second wave later this year.”
For the full CDC report, click here.

Associations of timing of physical activity with all-cause and cause-specific mortality in a prospective cohort study “Moderate-to-vigorous intensity physical activity (MVPA) at any time of day is associated with lower risks for all-cause, cardiovascular disease, and cancer mortality. In addition, compared with morning group (>50% of daily MVPA during 05:00-11:00), midday-afternoon (11:00-17:00) and mixed MVPA timing groups, but not evening group (17:00-24:00), have lower risks of all-cause and cardiovascular disease mortality. These protective associations are more pronounced among the elderly, males, less physically active participants, or those with preexisting cardiovascular diseases. Here, we show that MVPA timing may have the potential to improve public health.”

CDC panel recommends Bavarian Nordic's mpox vaccine for all adults at risk “Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Wednesday voted in favor of use of Bavarian Nordic's Jynneos vaccine for all adults at risk of mpox during an outbreak.
The panel of outside experts voted unanimously in favor of use of two doses of the vaccine, and finalizing the interim guidelines provided by CDC during the mpox outbreak in the United States.
The recommendation of the committee is based on studies that showed vaccine effectiveness of 66%-83% for patients with full vaccination and 36%-86% for partial vaccination with no severe adverse affect.”

FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers The FDA “oday, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized. The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP. Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers.”

Most parts of world saw maternal mortality rates spike in 2020 “Maternal mortality rates climbed or stagnated in nearly all regions across the world in 2020, according to a report released by U.N. agencies on Wednesday, marking a major setback in global efforts to combat complications during childbirth or pregnancy.
The report, which tracks maternal mortality nationally, regionally and globally from 2000 to 2020, showed there were an estimated 287,000 maternal deaths worldwide in 2020, and it marks only a slight decrease from 309,000 in 2016.
That translates to a woman dying every two minutes during childbirth or pregnancy, the report estimated.”

About healthcare IT

FDA Sees Spike in Drug Applications That Involve AI Tools “The number of drug applications that the FDA has received involving artificial intelligence (AI) and machine learning (ML) tools jumped from just a handful before the COVID-19 pandemic to more than 120 in 2021 and topped 150 in 2022.”

Teladoc Health Reports Fourth Quarter and Full Year 2022 Results Among the statistics: “Net loss totaled $3,810.1 million, or ($23.49) per share, for the fourth quarter of 2022, compared to $11.0 million, or ($0.07) per share, for the fourth quarter of 2021. Results for the fourth quarter of 2022 primarily included non-cash goodwill impairment charges of $3,772.8 million, or ($23.26) per share, stock-based compensation expense of $50.8 million, or ($0.31) per share, and amortization of acquired intangibles of $49.0 million, or ($0.30) per share.”

Does deidentification of data from wearable devices give us a false sense of security? A systematic review The quick answer is “No.”
“Correct identification rates were typically 86–100%, indicating a high risk of reidentification. Additionally, as little as 1–300 s of recording were required to enable reidentification from sensors that are generally not thought to generate identifiable information, such as electrocardiograms. These findings call for concerted efforts to rethink methods for data sharing to promote advances in research innovation while preventing the loss of individual privacy.”

About healthcare personnel

What’s your specialty? New data show the choices of America’s doctors by gender, race, and age Interesting breakdown and worth a read. The statistic on which the media is focusing is the 5.7% “Black or African American” category, which is significantly underrepresented given population proportion percentages (12%).

Today's News and Commentary

February 22, 2023 Joel Shalowitz

About Covid-19

WHO says independent panel of experts is evaluating evidence on new COVID variants to determine whether vaccines need to be updated “Members of the agency’s Technical Advisory Group on COVID-19 Vaccine Composition, an independent group of experts, outlined the process in a commentary in Nature Medicine journal, in which they agreed the vaccines are still offering a high level of protection against severe disease caused by all of the variants, including omicron, which is dominant globally.”

Veklury (Remdesivir) Reduced Risk of Mortality in Hospitalized COVID-19 Patients Across all Variant Time Periods in a Real World Study of More than 500,000 Hospitalized Patients “Two studies analyzed clinical practice information from the U.S. Premier Healthcare databases of more than 500,000 adult patients hospitalized with COVID-19. The overall analysis examined all-cause inpatient mortality rates at 14- and 28- days and demonstrated that initiation of Veklury within the first two days of hospital admission was associated with a statistically significant lower risk for mortality in all oxygen levels compared to matched controls that did not receive Veklury during their hospitalization for COVID-19. For patients with no documented use of supplemental oxygen at baseline, treatment with Veklury was associated with a 19% (p<0.001) lower risk of mortality at Day 28. Patients on low-flow or high-flow oxygen also had a 21% (p<0.001) and 12% (p<0.001) lower risk of mortality at Day 28, respectively. Patients on invasive mechanical ventilation/ECMO at baseline had a 26% (p<0.001) reduced risk for mortality at Day 28. These findings were observed throughout all variant time periods, including Omicron, in patients who did not require supplemental oxygen and across all levels of supplemental oxygen use, including those on invasive mechanical ventilation (IMV)/ECMO.”

About health insurance/insurers

CMS data: Medicare Advantage enrollment now more than 31M “The Centers for Medicare & Medicaid Services (CMS) released its latest look at enrollment in the MA program, which showed that nearly 30.9 million people had enrolled in MA plans, with most choosing plans that have prescription drug coverage. In addition, 308,881 people are enrolled in commercial Medicare-Medicaid plans, according to the data.
By comparison, about 29.1 million people had such coverage in February 2022, for a year-over-year increase of 7.1%. The 2023 data represent 776 MA contracts, up from 740 a year ago.
Enrollment in standalone prescription drug plans was 22.5 million, bringing total enrollment in private Medicare coverage to 54 million.”
See, also, this Chartis report: In a Shifting Market, Medicare Advantage Shows Continued—but Decelerating—Growth

CMS now accepting applications for extended bundled payment program “CMS began accepting applications Feb. 21 for its Bundled Payments for Care Improvement Advanced model.
Through May 31, acute care hospitals, physician groups and Medicare ACOs can apply to participate in the value-based program for two years beginning in January.”

About the public’s health

Pfizer RSV vaccine that protects infants could receive FDA approval this summer “KEY POINTS

The FDA is reviewing Pfizer’s RSV vaccine on an expedited basis and will make a decision on whether to clear the shot by August.
The single-dose vaccine is administered to expectant mothers in the late second to third trimester of their pregnancy.
The antibodies triggered by the shot are passed to the fetus, and they protect the infant from RSV after birth.”

About healthcare IT

Hospital Price Transparency: Progress And Commitment To Achieving Its Potential A great review of the topic by authors from CMS. One highlight to show the current program status: “As of January 2023, CMS had issued nearly 500 warning notices and over 230 requests for corrective action plans since the initial implementing regulation went into effect in 2021. Nearly 300 hospitals have addressed problems and have become compliant with the regulations, leading to closure of their cases. While it was necessary to issue penalties to two hospitals in 2022 for noncompliance (posted on the CMS website), every other hospital that was reviewed has corrected its deficiencies.”

A multi-site randomized trial of a clinical decision support intervention to improve problem list completeness “The CDS [clinical decision support] was highly effective at improving problem list completeness. However, the improvement in problem list utilization was not associated with improvement in the quality measures. The lack of effect on quality measures suggests that problem list documentation is not directly associated with improvements in quality measured by National Committee for Quality Assurance Healthcare Effectiveness Data and Information Set (NCQA HEDIS) quality measures. However, improved problem list accuracy has other benefits, including clinical care, patient comprehension of health conditions, accurate CDS and population health, and for research.”

About healthcare personnel

Board Rules that Employers May Not Offer Severance Agreements Requiring Employees to Broadly Waive Labor Law Rights The NLRB “issued a decision in McLaren Macomb, returning to longstanding precedent holding that employers may not offer employees severance agreements that require employees to broadly waive their rights under the National Labor Relations Act. The decision involved severance agreements offered to furloughed employees that prohibited them from making statements that could disparage the employer and from disclosing the terms of the agreement itself.”

About health technology

White House opts not to veto ITC ruling in favor of AliveCor in ECG patent battle with Apple “A potential import ban on the Apple Watch is still on the table as an International Trade Commission (ITC) ruling against the technology cleared presidential review this month.
Rulings such as the late December one between Apple and AliveCor—which determined the built-in ECG technology within some Apple Watches infringes on AliveCor’s own patented portable ECG devices—can be vetoed by the White House within 60 days. In this case, the Biden administration has allowed the ruling to stand, AliveCor announced this week.”

Philips Sees Another Ventilator Recall Deemed Class I “The FDA has identified a recall for certain reworked Philips Trilogy and Garbin ventilators as Class I, the most serious type of recall, as use of these devices can cause serious injuries or death…
This recall is for two potential issues. The adhesive used to attach the silicone sound abatement foam installed to replace PE-PUR foam may fail and potentially block the airpath. Philips also found some residual PE-PUR sound abatement foam in some reworked ventilators, which poses potential health risks.”

About healthcare finance

Amazon says it has completed $3.49 billion deal for One Medical “ Amazon.com Inc. says it has completed its purchase of One Medical parent 1Life Healthcare Inc., sealing the $3.49 billion acquisition after the US Federal Trade Commission declined to challenge it.
The deal gives the e-commerce giant a network of primary-care doctors, Amazon’s biggest move to date into the health care industry. One Medical operates more than 200 medical offices in 26 markets in the US. Customers pay a subscription fee for access to its physicians and digital health services.”

Today's News and Commentary

February 21, 2023 Joel Shalowitz

About Covid-19

Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis “Protection from past infection against re-infection from pre-omicron variants was very high and remained high even after 40 weeks. Protection was substantially lower for the omicron BA.1 variant and declined more rapidly over time than protection against previous variants. Protection from severe disease was high for all variants.”

About health insurance/insurers

Best Health Insurance Companies of 2023 FYI from “insure.com” Kaiser comes out first with United a close second.

About pharma

2022's 10 top clinical trial flops FYI

Novartis loses $940M arbitration case against Mitsubishi Chemical over Gilenya royalties “Novartis has made more than $30 billion from sales of its multiple sclerosis therapy Gilenya. But lately the drug’s decline has brought headaches for the Swiss pharma giant.
A series of patent defeats has led Novartis to a last ditch appeal with the U.S. Supreme Court. Now, the company has been told to fork over $940 million in royalties to Mitsubishi Chemical Group.”

About healthcare IT

59.7M patient records were breached in 2022 “In 2022, the number of patient records breached increased by 18 percent compared to 2021 to 59.7 million, according to a new report from healthcare analytics company Protenus Breach Barometer.”
And in a related article:
Reported HIPAA complaints and breaches shot up from 2017 to 2021: HHS “According to the report, the number of large HIPAA breaches rose by 58 percent between 2017 and 2021, and the number of complaints rose by 39 percent. The agency defines large breaches as ones that affect at least 500 individuals.”

Survey Finds 57% of U.S. Physicians Have Changed Their Perception of a Medication as a Result of Info on Social Media “A new joint survey from Sermo and LiveWorld found that 57% of U.S.-based physicians frequently or occasionally change their perception of a medication or treatment based on content they’ve seen on social media. Only 16% of surveyed physicians reported that their perceptions have never been influenced by social media.”

Today's News and Commentary

February 17, 2023 Joel Shalowitz

About Covid-19

White House mulls post-Covid emergency backstop for uninsured “The Biden administration is zeroing in on a plan to keep Covid vaccines, treatments and tests free for the uninsured into 2024, even as it plots a quicker wind-down of its broader pandemic response, four people with knowledge of the matter told POLITICO.”

About health insurance/insurers

The Joint Commission and Manchester Specialty Programs collaborate to provide insurance pricing benefits to eligible nursing homes and assisted living facilities JC accredited facilities can get premium discounts on insurance from this company. Like good drivers getting an insurance discount.

About hospitals and healthcare systems

Unfortunate trend continues (following 3 articles):
Alabama Hospital Association: Over a dozen rural hospitals at immediate risk of closing

Financial and Operational Impacts on Tennessee Hospitals Since the Onset of the Pandemic “The vast majority of hospitals at risk of closure in Tennessee are rural hospitals, though urban hospitals have also been stressed and are at a higher risk than pre-pandemic levels.”

Duke University Health reports $70M operating loss, overall profit “Overall income for the period totaled $28.8 million, boosted by positive returns on investment income.”
And when the market declines again…?

About pharma

Years after the first US biosim launches, doctors still have their concerns: survey “In the U.S., when a biosimilar is shown through a switching study to have comparable efficacy and safety to a reference product, it is classified as “interchangeable.” As such, it can be swapped out by a pharmacist for the original medicine.
But while the interchangeable designation is valuable, many manufacturers of biosimilars are not willing to undergo the time consuming and expensive studies that are required to gain the status…
When asked in the Sermo study whether regulatory agencies should do away with switching studies and deem all U.S. biosimilars interchangeable, 48% of doctors said they were unsure.
Similarly, when asked about the key factor in prescribing a biosimilar, 48% of doctors cited comparable efficacy data—as proven through a switching study. Meanwhile, only 19% of those surveyed said financial savings to the patient was an important factor.”

High drug prices are not justified by industry’s spending on research and development “Key messages:

From 1999 to 2018, the world’s 15 largest biopharmaceutical companies spent more on selling, general, and administrative activities than on research and development
Most of these companies also spent more on share buybacks and paying out dividends than on research and development
Most new medicines developed during this period offered little or no clinical benefit over existing treatments
Industry could generate more medically valuable and affordable innovation with existing resources
Government action is needed to encourage research and development focused on public health priorities”

About the public’s health

Vaping Dose, Device Type, and E-Liquid Flavor are Determinants of DNA Damage in Electronic Cigarette Users “We demonstrate a dose-dependent formation of DNA damage in oral cells from vapers who had never smoked tobacco cigarettes as well as exclusive cigarette smokers. Device type and e-liquid flavor determine the extent of DNA damage detected in vapers. Users of pod devices followed by mod users, and those who use sweet-, mint or menthol-, and fruit-flavored e-liquids, respectively, show the highest levels of DNA damage when compared to nonusers. Given the popularity of pod and mod devices and the preferability of these same flavors of e-liquid by both adult- and youth vapers, our findings can have significant implications for public health and tobacco products regulation.”

Investigation spotlights rise of for-profit ethics boards in research “Federal regulations require that certain research on human subjects — including those testing the safety of new drugs — first get approval from a registered institutional research board. These boards, which are made up of at least five members and can include researchers and academics, are designed to make sure that a study poses as little risk as possible and that participants have enough information to give consent.
While the majority of these boards are affiliated with universities, a small number have no affiliation with institutions conducting research. But according to a new report from the U.S. Government Accountability Office, these independent boards now account for the largest share of reviews of studies involving new drugs and biologics. Independent boards conducted 48 percent of such research regulated by the Food and Drug Administration in 2021, up from 25 percent a decade earlier, despite making up just 2 percent of all U.S. review boards.”

About health technology

Labcorp plots 2023 revenue growth despite a possible 90% drop in COVID test revenues “In a full-year earnings report published Thursday, Labcorp reported a 7.7% year-over-year drop in revenues in 2022, thanks almost entirely to a COVID diagnostics haul that weighed in at less than half the size of the previous year’s.
For all of 2022, Labcorp raked in $1.1 billion in revenues from sales of its PCR and antibody tests for the coronavirus—just over a 60% drop from 2021’s tally, which added up to $2.8 billion. Though an undeniably huge decrease, that was actually the best-case scenario for Labcorp, which predicted at the start of 2022 that COVID-related revenues for the year would fall at a rate between 60% and 75%.”

Chapter 1. Tourbillon watch movement

Chapter 2. Le Penseur (The Thinker): Auguste Rodin (1840 -1917), Musée Rodin, Paris

Chapter 3. The Four Horsemen of the Apocalypse: Albrecht Dürer (1471–1528), Metropolitan Museum of Art, New York

Chapter 4. Ward in the Hospital in Arles: Vincent Willem van Gogh (1853 –1890),
The Oskar Reinhart Collection, Winterthur, Switzerland

Chapter 5. The Anatomy Lesson of Dr. Nicolaes Tulp: Rembrandt Harmenszoon van Rijn (1606-1669), Mauritshuis, The Hague, Netherlands

Chapter 6. Royal Exchange, Lloyds Subscription Room: Thomas Rowlandson (1756–1827) and Augustus Charles Pugin (1762–1832), published as Plate 49 of Microcosm of London (1809)

Chapter 7. Photo of the first table model electrocardiogram, manufactured by the Scientific Instrument Company of London in 1911. Designed by Dr. Willem Einthoven.

Chapter 8. Tower of Babel: Pieter Bruegel the Elder (1525-69), Kunsthistorisches Museum, Vienna.

Chapter 9. Checklist

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