Today's News and Commentary

 About healthcare quality

Califf: Current evidence generation system in clinical research needs an overhaul “Clinical research in the US needs an overhaul to better optimize health outcomes in a way that matches advances in biomedical science, according to a recent perspective authored by US Food and Drug Administration Commissioner Robert M. Califf, published in Clinical Trials journal…
Califf outlined several areas where a new evidence generation system could improve these problems. Specific areas for improvement include better integration of high-quality data from clinical trials, electronic health records, and wearable devices/sensors; focusing clinical research operations to involve patients and clinicians on the front line; and creating a system of responsible data sharing with ethical constructs.”

About health insurance/insurers

 Elevance Health to acquire Blue Cross and Blue Shield of Louisiana “Elevance Health has inked a deal to acquire Blue Cross and Blue Shield of Louisiana, with the Pelican State insurer joining the Anthem Blue Cross affiliated plans.
The acquisition builds on an existing partnership between the two insurers, according to the announcement. The two jointly own Healthy Blue, a plan that serves Medicaid and dual-eligible beneficiaries.”

About hospitals and healthcare systems

 Organization and Performance of US Health Systems “In 2018, health system physicians and hospitals delivered a large portion of medical services. Performance on clinical quality and patient experience measures was marginally better in systems but spending and prices were substantially higher. This was especially true for small practices. Small quality differentials combined with large price differentials suggests that health systems have not, on average, realized their potential for better care at equal or lower cost.”
This important article adds a lot to the existing evidence on lack of benefits for mergers.
See, also,  the editorial: Health Systems—The Present and the Future

About pharma

 Amazon Pharmacy Introduces RxPass: Unlimited Prescription Medications for Only $5 a Month, Delivered Free to your Door—Available Exclusively for Prime Members  “Amazon today announced RxPass, a new Prime membership benefit from Amazon Pharmacy that offers patients affordable access to commonly prescribed generic medications that treat more than 80 common health conditions. With RxPass, Prime members can receive all of their eligible medications for one flat, low monthly fee of $5, and have them delivered free of charge. There are no hidden fees and no markups to the $5 per month subscription. RxPass is available starting today in most U.S. states.”

Optum Rx Launches Price Edge to Automatically Provide Members the Best Available Prescription Drug Price “Optum Rx, UnitedHealth Group’s (NYSE: UNH) pharmacy services company, has launched Price Edge, a tool that seamlessly compares available direct-to-consumer pricing for traditional generic drugs with insurance pricing to ensure members always get the lowest prescription drug price. Price Edge is being offered to all Optum Rx clients.
Compared to most direct-to-consumer prescription drug prices, Optum Rx already offers a lower price nearly 90% of the time and Price Edge ensures a competitive consumer price on generic drugs with every transaction. Price Edge scans available prices and automatically provides the lowest available pricing to the member. If there is a lower cost to the member outside of their insurance benefit, Price Edge automatically applies that price.
Unlike other direct-to-consumer pharmacy solutions or cash market pricing, transactions initiated through Price Edge count toward the member’s deductible and out-of-pocket maximum.”  

Sanofi Offers Cablivi Inpatient Warranty for Worsened or Non-Responsive Patients “Sanofi has offered a warranty on its drug, Cablivi (caplacizumab-yhdp), offering to pay the cost of six doses of the drug if the patient doesn’t respond, or 12 doses of the drug and the hospital stay if the patient’s condition worsens while on the drug…
The company will pay for six doses if treatment is discontinued because the patient still had low platelet counts after four days of combined treatment with Cablivi, plasma exchange and immunosuppressive therapy. The company will pay for the inpatient stay if the patient experienced a new drop in platelet count after initial platelet count normalization.”
Comment:The story is not the company or product, but another example of value-based guarantees in the pharma industry. What is unusual is the offer to pay for the hospitalization.

About the public’s health

 US Life Expectancy in 2021 Lowest Since 1996 “Life expectancy in the US decreased by about a half year between 2020 and 2021, from 77 years to 76.4 years, according to final 2021 mortality data from the National Center for Health Statistics. Life expectancy in 2021 was at its lowest level since 1996. The report attributed the drop mainly to increased deaths from COVID-19 and drug overdoses.”

Racial Health Equity and Social Needs Interventions Question  To what extent do studies of social needs interventions explain how race and ethnicity are conceptualized and used in analyses of intervention outcomes?
Findings  Of the 152 studies conducted in multiracial or multiethnic populations within this review of a scoping review, 44 studies included race or ethnicity in their analyses, but these analyses were informative in only 21 studies (14%). Only 4 (9%) were conceptually thoughtful about what race or ethnicity means.
Meaning  Social needs interventions have a unique opportunity to advance racial health equity if more attention is focused on conceptualization and use of race in intervention design and analysis.”

About healthcare personnel

 Stanford Medical School exits US News rankings, crafts its own system “Approximately one week after Boston-based Harvard Medical School withdrew from U.S. News & World Report's rankings, Stanford (Calif.) School of Medicine has done the same. 
Lloyd Minor, MD, Stanford School of Medicine's dean, announced the decision in a Jan. 23 letter to the community.”

Today's News and Commentary

About Covid-19

Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years “These data support the safety and efficacy of mRNA COVID-19 vaccines among children aged 5 to 11 years and endorse the universal age-based recommendations.” 

 FDA eyes major vaccine strategy changes “The FDA is considering a new COVID-19 vaccination strategy that would mirror the process for creating and administering annual flu shots, federal documents show.
The FDA's Vaccines and Related Biological Products Advisory Committee will convene Jan. 26 to discuss and vote on the proposed process.”

About health insurance/insurers

Majority in U.S. Still Say Gov't Should Ensure Healthcare From a Gallup poll: “STORY HIGHLIGHTS

  • 57% say government should ensure health coverage for all in U.S.

  • 53% favor health system based on private insurance; 43%, a government-run one

  • 72% of Democrats, 13% of Republicans support government-run system”

 HUMANA PROGRAM TARGETING LONELINESS FOR SENIORS ALSO CUTS MEDICAL COSTS KEY TAKEAWAYS
Loneliess affects some 40% of seniors in the US and accounts for roughly $6.7 billion in associated medical costs.
Humana and Wisdo Health launched a one-year pilot program in which almost 1,400 senior Medicare Advantage members with chronic health concerns were matched through an AI analysis with a trained peer, weekly coaching sessions and referrals to clinical and social determinants of health resources.
The program not only reduced loneliness and isolation, but cut down on ER and urgent care visits and saved roughly $1,000 per participating member per year in medical costs.”

Evaluation of High-Deductible Health Plans [HDHPs] and Acute Glycemic Complications Among Adults With Diabetes “In this study, patients with diabetes who switched to HDHPs were significantly more likely to experience serious, but preventable, acute diabetes complications compared with patients who remained in conventional insurance plans; these findings suggest the need for policy solutions to address health plan-mediated barriers to diabetes care.”
The questions remain: what is the proper out of pocket expenses and to which conditions do the apply?

CENTENE COMPLETES DIVESTITURE OF MAGELLAN SPECIALTY HEALTH “Centene Corporation announced today that it has completed the previously announced divestiture of Magellan Specialty Health to Evolent Health, Inc. (Evolent).”

About pharma

Civica chooses exclusive distributor “Civica Rx, a nonprofit drugmaker formed four years ago by health systems, picked AmerisourceBergen as its exclusive distribution partner.” 

About the public’s health

 Weekly U.S. Influenza Surveillance Report  Highlights:
—CDC estimates that, so far this season, there have been at least 25 million illnesses, 270,000 hospitalizations, and 17,000 deaths from flu.
—The cumulative hospitalization rate in the FluSurv-NET system was 1.6 times higher than the highest cumulative in-season hospitalization rate observed for week 2 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.
—The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
—All viruses collected and evaluated this season have been susceptible to the influenza antivirals oseltamivir, peramivir, zanamivir, and baloxavir.”

About healthcare personnel

 From STAT+ newsletter: “Roughly 2.9% of health care workers quit their jobs in November, equating to about 600,000 resignations, according to new data from the Bureau of Labor Statistics. That’s the second-highest quit rate in recent health care history, only behind the 3.1% rate in November 2021….
Burnout from caring for Covid-19 patients, rigorous work schedules, and stagnant or low wages continues to push many hospital nurses, technicians, nursing home staff, and others to switch to other health care settings — or leave the profession completely. But health care employers are still desperate for people to care for patients, which is giving employees leverage to demand higher paychecks.
The average hospital employee made $40 per hour this past November, up from $34 per hour before the pandemic in November 2019, according to BLS. But people who work in physician offices continue to make more: over $46 per hour as of November. Those working in outpatient centers are making about $36 per hour, up from about $31 before the pandemic. People who work in nursing homes and residential care facilities are still making only $23.65 per hour, up from a little over $19 per hour in November 2019.”

Today's News and Commentary

About health insurance/insurers

 The largest health insurance provider in each state FYI

Some Enrollees May Face Affordability Challenges Under Part D Redesign “An Avalere analysis finds that about 800,000 beneficiaries in 2024 and 200,000 in 2025 will have OOP costs that exceed 10% of their annual income.”

About hospitals and healthcare systems

Dollar General offers healthcare in 3 store parking lots “The nationwide retailer partnered with DocGo On-Demand to operate mobile clinics on select days outside the stores in Clarksville and Cumberland Furnace, Tenn. The clinics, set up in large vans, allow patients to schedule online or walk in without an appointment.”
Retail care expands to discount stores! 

About pharma

 AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report “With the oncoming loss of patent protection this year for its bell cow, Humira, AbbVie is taking advantage of its limited window with yet another price hike, this one 8%, for the treatment that generated $15.7 billion in the first three quarters of last year.
AbbVie has clocked in with the same 8% hike for another of its big-sellers, Skyrizi. Meanwhile, GSK has jacked up the cost of its shingles vaccine Shingrix, and Bristol Myers Squibb has done the same with CAR-T drugs Abecma and Breyanzi (9% each). For its part, Pfizer has raised the price on dozens of drugs…”

Biosimilar Competition and Payments in Medicare: The Case of Trastuzumab [Herceptin]“We find that the first biosimilar entrant's price was 15% lower than the originator brand in 2019, and the fifth biosimilar entrant's price in 2022 was 58% lower than the originator brand in 2019. Contrary to expectations from prior research, the originator biologic price in 2022 decreased 29% from its 2019 average sales price. Average treatment cost for the biologic and biosimilar versions of trastuzumab combined was $45,659 US dollars lower in 2022 compared with the year before biosimilar entry, 2018. Finally, biosimilar market share grew from only 7% in the first year of entry to 32% in the second year, when three biosimilars were on the market.”

FDA declines to give accelerated approval to Eli Lilly’s Alzheimer’s drug, firm says “The Food and Drug Administration is declining to grant accelerated approval to an experimental Alzheimer’s drug made by the pharmaceutical company Eli Lilly, saying the agency needs safety data on more patients, the company said Thursday.”

About healthcare quality 

Americans Sour on U.S. Healthcare Quality “STORY HIGHLIGHTS
—Less than half now rate U.S. healthcare quality as excellent or good
—Americans’ 72% positive rating of own healthcare quality also a new low”
Again, Americans evaluate prevalent conditions differently from their own situations.

About healthcare personnel

 Performance of ChatGPT on USMLE: Potential for AI-Assisted Medical Education Using Large Language Models [Preprint, not yet peer reviewed] “We evaluated the performance of a large language model called ChatGPT on the United States Medical Licensing Exam (USMLE), which consists of three exams: Step 1, Step 2CK, and Step 3. ChatGPT performed at or near the passing threshold for all three exams without any specialized training or reinforcement. Additionally, ChatGPT demonstrated a high level of concordance and insight in its explanations. These results suggest that large language models may have the potential to assist with medical education, and potentially, clinical decision-making.”
Can AI also pass written specialty boards?

Today's News and Commentary

About Covid-19

Pandemic Funding Saved More Americans From Medical Debt “The number of Americans who had trouble paying their medical bills dropped precipitously between 2019 and 2021, and funds from the American Rescue Plan and other federal pandemic relief programs may have been a reason why.
Overall, 10.8% of Americans responding to a federal survey in 2021 said they had had problems covering medical bills that year, down from 14% in 2019, according to researchers at the National Center for Health Statistics (NCHS), part of the U.S. Centers for Disease Control and Prevention.”

Israel says has not found a link between Pfizer COVID shot and stroke “Israel has not identified any evidence linking strokes to an updated coronavirus vaccine made by U.S. drugmaker Pfizer and its German partner BioNTech SE, according to a health ministry official.
On Friday, the U.S. Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data…
On Wednesday, the European Union's drug regulator also said it had found no safety signals in the region related to Pfizer's bivalent shot.”

About health insurance/insurers

 Health insurers well-positioned to weather inflation, utilization shifts in 2023: Fitch “Health insurers have a neutral credit outlook for the coming year as the increased focus on diversification paid off, according to a new analysis from Fitch Ratings.
In addition, the healthcare industry's unique "structural characteristics" have insurers set to weather fluctuations in healthcare utilization, inflation and ongoing concerns about an economic recession. Payers emerged from the pandemic well positioned as decreases in routine care offset the increased expenses related to care for patients with COVID-19.
Fitch upgraded the individual ratings for Cigna, Aetna and Centene in 2022. Cigna's credit outlook improved as it focused on diversification within its Evernorth subsidiary, while Aetna's parent company, CVS Health, significantly decreased the financial leverage from its 2018 acquisition of the insurer.
Centene earned a rating increase for a similar focus on business diversification as well as geographic diversification.”

About healthcare quality/safety 

Gaps in Recalls of Home-Use Medical Devices Top ECRI's Hazards List for 2023 "The 10 topics on ECRI's 2023 hazards list are listed below in rank order:

  1. Gaps in Recalls for At-Home Medical Devices cause patient confusion and harm

  2. Growing number of Defective Single-Use Medical Devices puts patients at risk

  3. Inappropriate use of Automated Dispensing Cabinet Overrides can result in medication errors

  4. Undetected Venous Needle Dislodgement or access-bloodline separation during hemodialysis can lead to death

  5. Failure to manage Cybersecurity Risks Associated with Cloud-Based Clinical Systems can result in care disruptions

  6. Inflatable Pressure Infusers can deliver fatal air emboli from IV solution bags

  7. Confusion surrounding Ventilator Cleaning and Disinfection requirements can lead to cross-contamination

  8. Common misconceptions about Electrosurgery can lead to serious burns

  9. Overuse of Cardiac Telemetry can lead to clinician cognitive overload and missed critical events

  10. Underreporting Device-Related Issues may risk recurrence”

About hospitals and healthcare systems

 Rural Emergency Hospitals From CMS, effective this month:
"REHs are a new Medicare Part A provider type. Section 125 of the Consolidated Appropriations Act of 2021 (CAA), Division CC defines REHs are facilities that meet these regulatory requirements (This list includes basic criteria. It isn’t all-inclusive.):
—Must enroll in Medicare
—Has a transfer agreement in effect with a Level I or Level II trauma center ● Must meet staff training and certification requirements, including:
—A staffed emergency department 24 hours a day, 7 days a week, with staffing requirements like those for Critical Access Hospitals (CAHs)
—A physician (as defined in Section 1861(r)(1) of the Social Security Act (the Act)), nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in Section 1861(aa)(5) of the Act) available to provide rural emergency hospital services in the facility 24 hours a day
—Meet certain licensure requirements, including:
○ Located in a state that provides for licensing of such hospitals under state or local law
○ Licensed under such law
○ Approved by the state or local agency as meeting the standards for such license
—Meet Conditions of Participation (CoPs) applicable to CAHs regarding emergency services and hospital emergency departments
—Don’t exceed an annual per patient average of 24 hours of services
—Don’t provide any acute care inpatient hospital services (other than post-hospital extended care services provided in a distinct part unit licensed as a skilled nursing facility (SNF))
—Was a CAH or small rural hospital with no more than 50 beds on December 27, 2020 (the date of enactment of the CAA)”

About the public’s health

Building the CDC the Country Needs Final Report of the Center for Strategic & International Studies Commission Working Group on the CDC. Read pages 10-21.

 Weekly U.S. Influenza Surveillance Report Highlights from the CDC report:

  • “CDC estimates that, so far this season, there have been at least 24 million illnesses, 260,000 hospitalizations, and 16,000 deaths from flu.

  • The cumulative hospitalization rate in the FluSurv-NET system was 1.8 times higher than the highest cumulative in-season hospitalization rate observed for week 1 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.

  • The number of flu hospital admissions reported in the HHS Protect system decreased compared to week 52.

  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.”

About healthcare IT

Websites Selling Abortion Pills Are Sharing Sensitive Data With Google “Online pharmacies that sell abortion pills are sharing sensitive data with Google and other third parties, which may allow law enforcement to prosecute those who use the medications to end their pregnancies, a ProPublica analysis has found.
Using a tool created by the Markup, a nonprofit tech-journalism newsroom, ProPublica ran checks on 11 online pharmacies that sell abortion medication to reveal the web tracking technology they use. Late last year and in early January, ProPublica found web trackers on the sites of at least nine online pharmacies that provide pills by mail: Abortion Ease, BestAbortionPill.com, PrivacyPillRX, PillsOnlineRX, Secure Abortion Pills, AbortionRx, Generic Abortion Pills, Abortion Privacy and Online Abortion Pill Rx.”

About healthcare personnel

 Meet America's largest employer of physicians: UnitedHealth Group “With at least 60,000 employed or aligned physicians across 2,000 locations in 2023, Optum has cemented itself at the forefront of the quickly changing healthcare delivery landscape. For comparison, Bloomberg reported in 2021 that Ascension employs or is affiliated with 49,000 physicians, HCA has 47,000 and Kaiser has 24,000.”

The primary care battle: Where Optum, CVS, Walgreens stand A good summary of the topic.

About healthcare finance

 Large healthcare bankruptcies rose 84% in 2022, though hospitals mostly dodged the bullet “Major healthcare bankruptcies jumped by 84% from 2021 to 2022, returning the sector to a pre-pandemic rate of new Chapter 11 filings, according to new research from Gibbins Advisors.
The healthcare restructuring advisory firm said it found a total of 46 bankruptcies among organizations with more than $10 million in liabilities during 2022. The increase was largely driven by activity in the final months of the year, with a nearly threefold uptick in new filings when comparing the fourth quarter and the first quarter.
For comparison, there were 51 such bankruptcy filings in 2019, 45 in 2020 and just 25 in 2021, according to the report (PDF).
Senior care facilities and pharmaceutical companies bore the brunt of the damage in 2022, with the former subsector bearing 12 bankruptcy filings and the latter 14.” 

Today's News and Commentary

About Covid-19

World Health Organization releases latest set of COVID-19 guidelines “The guidelines include advice on treatments, isolation periods and wearing masks.”
These recommendations are worth reading.

 About healthcare quality

High-Volume Orthopedic Surgeons Generate Better Outcomes at Lower Costs Not new qualitative information, but there are some quantitative findings that are interesting. For example, look at the graphics for differences between sites of treatment.

About health insurance/insurers

Record High in U.S. Put Off Medical Care Due to Cost in 2022 “STORY HIGHLIGHTS

  • 38% say they put off treatment, up 12 percentage points from 2021

  • 27% say medical treatment was for a very or somewhat serious condition

  • Lower-income, younger adults, women most likely to report delaying care

Medicare Advantage enrollment hits record 30 million “Over 30 million people are now enrolled in Medicare Advantage plans, according to CMS data released Jan. 17.
Total enrollment reflects the Jan. 1 payment date, and payments reflect accepted enrollments through Dec. 2, 2022.
The record enrollment marks a significant milestone for the public-private program. In 2022, 28.4 million people were enrolled in MA out of 58.6 million Medicare beneficiaries overall – or 48 percent.”

UnitedHealth Group and Allianz SE Remain Atop AM Best’s Largest Insurer Rankings  Measured by net premiums written (NPW), the top three global firms are American healthcare companies.

Medicare Commission Highlights MA’s Efficiencies in Delivering Benefits to Over 30 Million Americans “During a recent public meeting, the Medicare Payment Advisory Commission (MedPAC) reported that Medicare Advantage (MA) plans are far more efficient at delivering basic benefits than original Medicare. For 2023, MedPAC estimates MA plan bids average just 83% of original Medicare costs, down from an average of 96% a decade ago. Furthermore, payments to MA plans, including bonuses for achieving higher quality ratings in the Medicare stars program, continue to be on par with original Medicare spending.”
This announcement comes from AHIP. You should check the entire MedPAC presentation for a more nuanced report.

CMS Announces Increase in 2023 in Organizations and Beneficiaries Benefiting from Coordinated Care in Accountable Care Relationship Yesterday, the Centers for Medicare & Medicaid Services (CMS) announced that three innovative accountable care initiatives will grow and provide higher quality care to more than 13.2 million people with Medicare in 2023. More than 700,000 health care providers and organizations will participate in at least one of the three initiatives – the Medicare Shared Savings Program and two CMS Innovation Center accountable care model tests. This growth furthers achieving the CMS’ goal of having all people with Traditional Medicare in an accountable care relationship with their health care provider by 2030…
announcement includes three CMS accountable care initiatives: the Medicare Shared Savings Program (Shared Savings Program), the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model,and the Kidney Care Choices (KCC) Model.”

About pharma

 Florida agency warns pharmacists not to dispense abortion pills “With pharmacies in some states preparing to dispense abortion pills, Florida’s Agency for Healthcare Administration sent a letter Thursday to all state health care providers warning them that to do so in Florida is illegal.
‘The Agency issues this alert to remind providers that they must continue to comply with Florida laws that govern the performance of abortions,’ the Florida agency said via an email.
The warning follows the U.S. Food and Drug Administration’s early January decision allowing retail pharmacies to stock and dispense abortion pills in states that allow the procedure.”

Woman Convicted for Billing Claims as Part of $65 Million Pharmaceutical “Coupon” Fraud “According to court documents and evidence presented at trial, Berro, engaged in a conspiracy to submit fraudulent reimbursement claims to numerous pharmaceutical manufacturer’s co-pay assistance programs.  These manufacturer-sponsored “coupon” programs exist to assist real patients with the often-high costs associated with name brand prescription drugs. The evidence showed that Berro, who participated in the scheme for nearly a year, was a biller for multiple pharmacies.  In that role, she created fake “prescriptions” for fake “patients” by taking addresses from real estate lists, making up names and birth dates, selecting expensive name brand, and then ultimately pairing them with real doctors’ names and credentials.”

About the public’s health

U.S. birth rates drop as women wait to have babies “American women are having fewer babies, and they're having them later in life, government figures released Tuesday show. Data collected by the National Center for Health Statistics — the Centers for Disease Control and Prevention's statistic arm — showed a sharp decline in fertility rates in recent years, with most women having an average of 1.3 babies and an increasing percentage giving birth at age 35 or older.”

Moderna says RSV vaccine 84% effective at preventing symptoms in older adults “Moderna Inc (MRNA.O) said on Tuesday that its experimental messenger RNA vaccine for respiratory syncytial virus (RSV) was 83.7% effective in a late-stage trial at preventing at least two symptoms, such as cough and fever, in adults aged 60 and older.”

 Rates of Follow-up Colonoscopy After a Positive Stool-Based Screening Test Result for Colorectal Cancer Among Health Care Organizations in the US, 2017-2020 Question  What are the overall rates of follow-up colonoscopy (FU-CY) after a positive stool-based test result, and what factors are associated with FU-CY rates, including the early COVID-19 pandemic?
Findings  In this cohort study of 32 769 individuals from 39 different health care organizations, the overall FU-CY rate within 1 year of a positive stool-based test result was 56%. Race, ethnicity, insurance type, type of test (fecal immunochemical tests or multitarget stool DNA), health care organization, and the COVID-19 pandemic were significantly associated with these rates.
Meaning  Targeted interventions to improve overall FU-CY rates and to cover the backlog of colonoscopies from the peak COVID-19 months (March to June 2020) are necessary to achieve the full clinical benefits from stool-based colorectal cancer screening tests.”

About healthcare IT

 New CPT codes added for AI, virtual reality For examples:
— 0740T and 0741 to report AI insulin titration.
— 0764T and 0765T to report AI cardiac function services

About healthcare personnel

 Harvard Medical School Withdraws From U.S. News Ranking Are more medical schools going to follow, as happened with law school withdrawals from the rankings?

Today's News and Commentary

About hospitals and healthcare systems

 America's Best Hospitals2023 America's 250 Best Hospitals Latest from Healthgrades.

100 of the largest hospitals and health systems in America | 2023 FYI

Dual-eligible patients impact hospitals' star ratings, but blanket methodology adjustments aren't the answer, researchers say “By comparing the average scores of over 3,000 facilities for each of the five measure groups [mortality, readmission, patient experience, safety, and timely and efficient care], policy researchers found that worse scores weren’t a constant across hospitals with higher portions of dual-eligible patients (those eligible for both Medicare and Medicaid).
Specifically, while readmission and patient experience scores were worse among hospitals with the highest proportion of dual-eligibles, the analysis also found that these hospitals scored higher on average across CMS’ mortality measures in 2021. Performances across the remaining two measures were ‘generally similar’ with a slight edge to hospitals with very small proportions of dual-eligibles.”
Read the entire article for the “full picture.”

2022 M&A in Review: Regaining Momentum “With 17 announced transactions, the fourth quarter of 2022 was one of the most active quarters we have seen since the COVID-19 pandemic began near the end of Q1 2020. Four of the 17 announced transactions met our definition of “mega merger,” in which the smaller party has annual revenues in excess of $1 billion, and a fifth had a smaller party with revenues in the $500 million to $1 billion range. This was the third consecutive quarter in 2022 in which the average size of the smaller party across all announced transactions exceeded $800 million. As a result, the average smaller party size for the entire year reached an historic high of $852 million, well above 2021’s then-record size of $619 million.”
Read the rest of the article for stats on the entire year. 

About pharma

Pfizer pledges to sell all its products at cost to poor countries “Pfizer has expanded its program to provide drugs at cost to the world’s poorest countries from 23 patented medicines to its entire suite of approximately 500 products.” 

 Protesting 'punitive' clawbacks, AbbVie and Eli Lilly bow out of British drug pricing scheme “AbbVie and Eli Lilly have exited the U.K.’s Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), a government-industry accord that traces its roots to NHS’ formation, according to local trade group The Association of the British Pharmaceutical Industry (ABPI).
The move, which was prompted by a recent spike in government repayment rates, should send a ‘warning signal’ to the U.K. that pharma companies may be unwilling to shoulder ‘increasingly punitive revenue clawbacks,’ ABPI said in a release.”

Bayer cites "innovation unfriendly" Europe in pharma focus shift to US, China “Bayer's pharma division head Stefan Oelrich says ‘big mistakes’ by EU and UK policy makers are turning the continent into an ‘innovation unfriendly’ place to do business, and prompting the company to shift the focus of its drug unit elsewhere instead, according to a report in the Financial Times. ‘European governments are trying to create incentives for research investments, but they are making our lives miserable on the commercial side,’ Oelrich said, adding ‘if you have no sales, you can benefit on the cost side as much as you want, but it is not a good equation.’
As a result, Oelrich says Bayer is ‘deprioritising Europe to some degree’ and focusing on the US and China, where the company's pharma division has already established a sizeable presence.”

About healthcare personnel

 Medical Residents Unionize Over Pay, Working Conditions “Physicians-in-training at top teaching hospitals across the country are joining unions, demanding higher pay and better working conditions.
The Committee of Interns and Residents, the largest group representing doctors in residency and fellowship programs, said it added chapters at five teaching hospitals last year and two in 2021, up from a prepandemic pace of roughly one a year. CIR, which is affiliated with the Service Employees International Union, said it represents about 15% of the nation’s 140,000 residents and fellows.” 

Today's News and Commentary

About Covid-19

 WHO: XBB.1.5. COVID-19 variant spreads faster, isn't more dangerous “The World Health Organization said the Omicron XBB.1.5. COVID-19 variant, known for its resistance to antibodies, does not have any known mutations that cause more harm to people than the other variants.
’XBB.1.5. does not carry any mutation known to be associated with potential change in severity,’ according to a WHO risk assessment released Wednesday.”

About health insurance/insurers

 UnitedHealth kicks off Q4 earnings, reports $4.8B in profit for the quarter “UnitedHealth Group beat the Street yet again in the fourth quarter, posting $4.8 billion in profit, according to its earnings report released Friday morning.
The healthcare giant's $82.8 billion in fourth-quarter revenue also surpassed Wall Street's expectations, according to analysts at Zacks Investment Research. Both figures were up from the prior-year quarter, where UnitedHealth reported $73.7 billion in revenue and $4.1 billion in profit.
For the full year 2022, UnitedHealth Group brought in $324.2 billion in revenue and $20.1 billion in profit. By comparison, the company reported $287.6 billion in revenue and $17.3 billion in profit for full-year 2021.”
Read the article and earnings report for UnitedHealthcare and Optum performances.

About healthcare quality and safety 

The Joint Commission elevates health care equity standard to National Patient Safety Goal “The Joint Commission announced it is elevating Leadership (LD) Standard LD.04.03.08 – which addresses health care disparities as a quality and safety priority – to a new National Patient Safety Goal (NPSG) for all critical access hospitals and hospitals, as well as some ambulatory care organizations and behavioral health care and human services organizations that provide certain services, effective July 1, 2023. 
Current requirements for Joint Commission-accredited organizations will not change. The intent behind the standard and associated elements of performance will remain the same; however, they will now be stated as NPSG Goal 16. The purpose of NPSGs is to improve patient safety – focusing on significant problems in health care and specific actions to prevent and solve them.”

About pharma

 California Lawsuit Accuses Drugmakers of Insulin Overcharging “California is suing the United States' leading insulin makers and pharmacy benefit managers, accusing them of using their market power to overcharge patients for the life-saving drug, the state's attorney general announced on Thursday.
The lawsuit, filed in California Superior Court in Los Angeles, targets Eli Lilly and Co, Novo Nordisk A/S and Sanofi SA, which together make more than 90% of the insulin drugs sold globally.
It also names the three largest pharmacy benefit managers (PBMs) - UnitedHealth Group Inc's Optum unit, CVS Health Corp's CVS Caremark and Cigna Corp's Express Scripts. PBMs maintain the lists of drugs covered by health insurance plans and negotiate prices with manufacturers, and the top three account for about 80% of the market.”

Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019 “In this cross-sectional study of 18 top-selling brand-name drugs, excluding 1 anomaly, Medicaid average net prices declined from 2015 to 2019. Simultaneously, for non-Medicaid payers, net price increased more than previously published marketwide growth rates, raising the importance of restraining drug price growth in non-Medicaid markets. Rigorous and transparent methods to estimate Medicaid discounts are imperative to understand patterns in Medicaid and non-Medicaid prices and develop policies that better align drug prices with clinical benefits”

Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021 “Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies. Manufacturers’ television advertising spending on included products rated as low therapeutic value was $15.9 billion from 2015 to 2021.”

About the public’s health

Cancer statistics, 2023 Annual report from The American cancer Society:In summary, although cancer mortality rates continue to decline, future progress may be attenuated by rising incidence for breast, prostate, and uterine corpus cancers, which also happen to have the largest racial disparities in mortality.”

Vaccination Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2021–22 School Year “During the 2021–22 school year, coverage decreased again to approximately 93% for all state-required vaccines. The exemption rate remained low (2.6%). An additional 3.9% without an exemption were not up to date with measles, mumps and rubella vaccine. Despite widespread return to in-person learning, COVID-19–related disruptions continued to affect vaccination coverage and assessment for the 2021–22 school year, preventing a return to prepandemic coverage.”

About health technology

 Exclusive: Illumina to face EU fine of 10% of turnover over Grail deal -sources “U.S. life sciences company Illumina is likely to face a fine of 10% of its global annual turnover, the maximum penalty, for closing its takeover of Grail without waiting for EU antitrust approval, people familiar with the matter said.
Last month Illumina defended its case before senior European Commission and national competition officials at a closed hearing but failed to convince them, the people said.”

Today's News and Commentary

About Covid-19

White House extends COVID-19 public health emergency once again “The Department of Health and Human Services (HHS) on Wednesday officially renewed the ongoing public health emergency for the COVID-19 pandemic amid concerns over a more transmissible viral mutation and broad pandemic fatigue.
The announcement by HHS Secretary Xavier Becerra marks the 12th renewal of the COVID-19 public health emergency, which was first declared by former HHS Secretary Alex Azar in January of 2020.
Each public health emergency declaration lasts for 90 days before expiring or getting renewed. While it is not required by any laws or department rules, Becerra has publicly committed to giving state governments and health care stakeholders a 60-day notice if plans to allow the declaration to expire.”

 Long covid outcomes at one year after mild SARS-CoV-2 infection: nationwide cohort study “This nationwide study suggests that patients with mild covid-19 are at risk for a small number of health outcomes, most of which are resolved within a year from diagnosis.” 

About health insurance/insurers

 A record 15.9M people enrolled in ACA marketplace plans so far, CMS says “A record 15.9 million people have enrolled for insurance coverage on the Affordable Care Act marketplace through Jan. 7, representing a 13% increase over last year and setting a new record, according to the Centers for Medicare and Medicaid Services.”

About hospitals and healthcare systems

The Safety of Inpatient Health Care “In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care–associated infections (11.9%).
Conclusion: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement.”

 Investment Value Declines Erode Not-for-Profit Hospitals’ Liquidity “Not-for-profit hospitals’ financial reserves have declined from 2021 peaks as a result of investment losses and increased liquidity demands to cover rising expenses, Fitch Ratings says. Not-for-profit hospitals generally have strong liquidity relative to debt repayment obligations and business risk, but recent unrestricted liquidity erosion is expected to bring balance sheet metrics more in line with pre-pandemic historical averages. Lower liquidity and lower operating margins could begin to have a negative effect on hospitals’ credit profiles.”

About pharma

 Spotlight On: The drugs that will shape 2023 A great short review.

Mark Cuban's pharmacy partners with 3rd PBM “Mark Cuban Cost Plus Drugs Co. and pharmacy benefit manager RxPreferred Benefits partnered to bring Mr. Cuban's online pharmacy to employers and their members part of the PBM, the two companies said Jan. 11.”

About healthcare personnel

 New York City nurses end strike as tentative agreements reached “ Nurses at the hospitals reached tentative deals that improve staffing ratios, the union said in a Jan. 12 news release. 
At Mount Sinai, the tentative contract includes "wall-to-wall safe staffing ratios for all inpatient units with firm enforcement" to ensure improved staffing levels, the union said. At Montefiore, the tentative contract includes new staffing ratios in the emergency department. 
The tentative contract at Montefiore also includes a 19.1 percent wage increase compounded over three years, as well as increases in registered nurse and nurse practitioner staff.”

About health technology

Upstart Element ratchets up race for cheaper DNA sequencing with a $200 genome “…genomics startup Element Biosciences on Wednesday announced it can now read a whole human genome for as little as $200…
Element’s announcement, made during the J.P. Morgan Healthcare Conference, comes after Illumina and Ultima made commitments to bring the cost of reading a whole genome down to $200 and $100, respectively. But neither company has delivered on those plans just yet, whereas Element’s reduced price is immediately available on an instrument it launched last year.”

 Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls Findings  In this cross-sectional analysis of 156 cases of 510(k)–authorized devices with Class I recalls from 2017 through 2021, 44.1% used predicates with Class I recalls. In addition, 48.1% of these devices were subsequently used as predicates to authorize descendant devices later subject to Class I recalls. The risk of a Class I recall was 6.40 times higher for descendants that used predicates with Class I recalls than for devices using Class I recall–free predicates.
Meaning  Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety.”

Today's News and Commentary

About health insurance/insurers

 Millions of Uninsured People Can Get Free ACA Plans From KFF research: “…updating the analysis with 2023 ACA premiums and subsidy amounts, we now find that about 5 million uninsured people are eligible for an ACA Marketplace plan that is essentially free. (This does not include uninsured people who previously fell in the family glitch and who may now be eligible for free plans, so the number of people eligible for a free plan may be slightly higher, though most people in the family glitch were already insured).”
Now the task is identifying those people/families and getting them on the insurance rolls.

HCSC Community Support Strategy Increases Focus on Social Barriers to Health “Health Care Service Corporation (HCSC) is realigning its community investments in 2023 into five newly redesigned strategic pillars to better support its umbrella mission of expanding access to care….
The new pillars are:  
Economic Opportunity and Stability: Addressing issues such as poverty, removing barriers to employment, providing good jobs and upskilling.
Nutrition: Supporting efforts to decrease hunger and increase access to nutritious food.
Neighborhood and Built Environment: Focusing on affordable healthy housing, access to transportation and access to physical activity.
Locally Defined Health Solutions: Addressing hyperlocal health and human service needs.
Optimal Health Outcomes: Helping close gaps in care, specifically around six priority areas: immunizations, diabetes care, cardiovascular care, behavioral health, early detection cancer screening and maternal and infant health.”

Comparing Detection, Treatment, Outcomes, and Spending for Patients with Type 2 Diabetes Between Medicare Advantage and Fee-For-Service Medicare “Avalere created cohorts for each disease phase, comprised of matched comparison groups of MA and FFS patients.
Findings
• Among patients with prediabetes who developed type 2 diabetes:
o MA patients received a type 2 diabetes diagnosis earlier (relative to the date of the prediabetes diagnosis) than FFS patients, and
o MA patients had a lower diabetes severity score at diagnosis than FFS patients.
• Among patients with incident diabetes, MA patients were more likely than FFS patients to fill prescriptions for medications to treat diabetes and related conditions within the first year of diagnosis.
o Similarly high shares of MA and FFS patients filled prescriptions for blood pressure and cholesterol medications.
• Among patients with chronic diabetes:
o Similarly high shares of MA and FFS patients visited primary care providers,
o MA patients were more likely than FFS patients to receive preventive care, including diabetes- related office visits and testing for kidney disease, and
o MA patients were less likely than FFS patients to require dialysis.
• Among patients with prediabetes and diabetes:
o MA patients had fewer emergency department visits and hospital admissions than FFS patients,
o Both MA and FFS patients rarely had avoidable hospital admissions, and
o Total medical spending was lower for MA patients than FFS patients. However, among patients with diabetes, MA patients had higher diabetes-related spending than FFS patients.
• Among dual eligible patients with diabetes (i.e., patients who are enrolled in both Medicare and Medicaid), MA patients were more likely than FFS patients to visit a primary care provider and fill prescriptions for diabetes medications. Total medical spending was lower for these MA patients than these FFS patients.”
Comment: The reasons these studies are done is to make sure that, compared to Medicare FFS, the MA economic model is not compromising patient care; as this study shows, the results are frequently the opposite.

About pharma

 BioNTech buys UK AI start-up InstaDeep in £562mn deal  “BioNTech has agreed to buy UK artificial intelligence start-up InstaDeep for up to £562mn in its biggest-ever deal, as the German company expands beyond the Covid-19 vaccine that transformed its fortunes.”

District court remands 340B underpayment remedy to HHS despite hospitals' push for immediate relief “The Department of Health and Human Services (HHS) will have the final say in how to best compensate 340B hospitals for years of underpayments, disappointing industry groups that had hoped the courts would order a swift resolution.
For months, the courts have been unraveling a June Supreme Court decision declaring a nearly 30% payment rate cut first introduced in 2018 to be unlawful. The top court unanimously rejected HHS’ argument that it did not need to survey hospitals’ acquisition costs before introducing the adjustment but returned the case to lower courts to address potential remedies.”

The Big Three PBMs’ 2023 Formulary Exclusions: Observations on Insulin, Humira, and Biosimilars “For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies.
Each exclusion list now contains about 600 products. Growth in the number of excluded drugs slowed for the second year, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.”
Read the entire article, it is an excellent current summary and has links to the formulary changes for those “big 3” PBMs.

Airsupra (PT027) approved in the US for asthma “First and only rescue medication approved in the US for as-needed use to reduce risk of asthma exacerbations…
Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. It is being developed by AstraZeneca and Avillion.”

About healthcare personnel

 CMS Awards 200 New Medicare-funded Residency Slots to Hospitals Serving Underserved Communities “Medicare & Medicaid Services (CMS) took a critical step to advance health equity and access to care, awarding the first 200 of 1,000 Medicare-funded physician residency slots to enhance the health care workforce and fund additional positions in hospitals serving underserved communities. Approximately three-quarters of the new positions will be for primary care and mental health specialties.” 

About healthcare finance

 GE HealthCare makes first acquisition as independent company “Chicago-based GE HealthCare, which spun off from General Electric on Jan. 4, has agreed to purchase Imactis, a maker of advanced radiology equipment.
GE HealthCare did not disclose financial terms of the deal but said in a statement that it intends to fund the transaction with cash on hand. The deal is subject to regulatory approval. GE HealthCare, which makes medical imaging machines, diagnostic tools and digital products used by hospitals, did not immediately respond to a request for comment.
mactis' primary product, CT-Navigation, is an ergonomic device and software duo that uses minimally invasive techniques to perform diagnostic and therapeutic medical procedures like ablations, aspiration, biopsies and body cavity drainage.”

Today's News and Commentary

2022 Shkreli Awards “Welcome to the 6th annual Shkreli Awards, the Lown Institute’s top ten list of the worst examples of profiteering and dysfunction in healthcare, named for the infamous ‘pharma bro’ Martin Shkreli.”
Well worth reading. These cases are appalling!

About Covid-19

Biden team eyes end of Covid emergency declaration and shift in Covid team “Senior Biden officials are targeting an end to the emergency designation for Covid as soon as the spring, after debating doing so last summer and taking a pass, three people with knowledge of the matter told POLITICO. Should they do so, such a move would represent a major pivot point in the country’s battle with the pandemic.
The decision, which has not yet been finalized amid more immediate efforts to manage a recent spike in Covid cases, would trigger a complex restructuring of major elements of the federal response — and set the stage for the eventual shifting of greater responsibility for vaccines and treatments to the private market. It would kickstart a transition away from the White House-led crisis operation and toward treating the virus as a continuous long-term threat.”

Moderna Considers Price of $110-$130 for Covid-19 Vaccine “The expected price for commercial insurers would be significantly higher than the per-dose cost in Moderna’s supply contracts with the federal government. Moderna’s updated booster shots cost about $26 per dose in a federal supply contract signed in July 2022. The original vaccine cost about $15 to $16 per dose in earlier supply contracts”

COVID-19 vaccine acceptance increased globally in 2022 “ Global willingness to accept a COVID-19 vaccine increased from 75.2% in 2021 to 79.1% in 2022, according to a new survey of 23 countries that represent more than 60% of the world’s population… Vaccine acceptance decreased in eight countries however, and nearly one in eight vaccinated respondents were hesitant about receiving a booster dose.”

Chinese bank tries to entice wealthy customers with mRNA vaccines “A Chinese state-owned bank in Hong Kong is offering customers one shot of an mRNA vaccine if they make a deposit of HK$4mn ($512,000), as it seeks to entice mainland clients who have until now only had access to locally produced jabs. The BioNTech/Pfizer mRNA vaccine is not widely available on the mainland but has long been available for free to permanent residents of Hong Kong and Macau as Beijing allowed the two territories to pursue a different vaccination strategy.”
Better than a toaster?

About health insurance/insurers

 China’s Covid patients face medical debt crisis as insurers refuse coverage “Chinese patients suffering from Covid-19 are struggling under mounting medical bills after state-backed health insurance schemes reduced or dropped coverage in response to an unprecedented wave of infections sweeping across the country. At least 14 Chinese cities and provinces have stopped providing free treatment for coronavirus after Beijing abruptly rolled back its zero-Covid strategy last month, according to local government announcements. For three years, Chinese patients had received subsidised care for the virus.”
Comment: Just because a country provides national health insurance, it doesn’t mean the insurance is adequate or that it is not subject to cutbacks in economically challenging times.

About pharma

 FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs “The Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies.
The agency, which must sign off before companies can begin testing an experimental drug in people, has long used its authority to place holds on studies due to safety concerns. As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a Wall Street Journal review of FDA data on clinical holds, some of which was obtained through a Freedom of Information Act request.
The agency halted clinical trials for experimental drugs an average of 664 times each year from 2017 to 2021, up from 557 each of the previous five years, according to the review of agency data. Through mid-December last year, the FDA had placed 747 of the holds.” 

Carbon Health nabs $100M, CVS Health partnership to pilot primary care in retail stores “Startup Carbon Health is partnering with CVS Health to pilot its primary and urgent care clinic model in the drugstore giant's retail stores.
CVS' corporate venture arm also led a $100 million investment to accelerate Carbon Health's expansion into new markets. The series D round will fuel Carbon Health's investment in technology and ramp up new value-based care arrangements, executives said in a press release.”

CVS exploring acquisition of Oak Street Health “According to people familiar with the matter, a deal could be reached within weeks that would value Oak Street at more than $10 billion, including debt.
But talks between the companies are ongoing and could end without an agreement, according to the sources, who asked not to be identified. 
Oak Street Health runs primary care centers across the U.S. for recipients of Medicare and has private equity firms such as General Atlantic and Newlight Partners among its shareholders.”

U.S. Supreme Court rebuffs Pfizer plan to help patients pay for heart medication “The U.S. Supreme Court on Monday turned away Pfizer Inc's bid to revive its plan to cover out-of-pocket expenses of Medicare patients for drugs costing $225,000 a year to treat a rare heart condition after federal officials found that the drugmaker's arrangement could amount to illegal kickbacks.”

About healthcare IT

 2022 year-end digital health funding: Lessons at the end of a funding cycle “2022’s total funding among US-based digital health startups amounted to $15.3B across 572 deals, with an average deal size of $27M. Not only did 2022’s annual funding total come in at just over half of 2021’s $29.3B2, but it also just squeaked past 2020’s $14.7B sum. Notably, 2022’s year’s Q4 $2.7B total was less than half of last year’s Q4 raise ($7.4B).”

About healthcare personnel

 The fight over how to deliver bad news to patients This Politico article explores the downside of making test results immediately available to patients.

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW “As of January 5, 2023, there are 628 (19.5%) counties, districts, or territories with a high COVID-19 Community Level, 1,351 (41.9%) with a medium Community Level, and 1,241 (38.5%) with a low Community Level. Compared with last week, the number of counties, districts, or territories in the high level increased by 10.6%, in the medium level increased by 1.8%, and in the low level decreased by 12.4%. Overall, 49 out of 52 jurisdictions had high- or medium-level counties this week. Hawaii, Maine, and Wyoming are the only jurisdictions to have all counties at low Community Levels.”
The interactive map helps you track what is happening in your county. 

 AstraZeneca’s preventative COVID treatment likely not effective against XBB.1.5: FDA “The Food and Drug Administration (FDA) said on Friday that AstraZeneca’s preventative monoclonal antibody treatment for COVID-19 is likely ineffective against the XBB.1.5 omicron subvariant due to its similarity to other mutations of the virus that are also not neutralized by the treatment.
In a statement, the FDA said it ‘does not anticipate that Evusheld will neutralize XBB.1.5.’”

Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023 “The mRNA juggernaut reported that Spikevax generated approximately $18.4 billion in revenue last year. The number was short of the company’s original estimate of $22 billion at the start of the year but did exceed its 2021 sales of $17.7 billion…
On Monday, Moderna also projected 2023 sales of the vaccine to reach at least $5 billion. That figure does not account for contracts that could be signed this year. The company specified the potential for deals with the U.S., Europe and Japan, among others.”

About pharma

 Teva's $4.25B opioid settlement gets support from 48 states and will move forward “After proposing a blockbuster $4.25 billion opioid settlement, the drugmaker has secured participation from 48 states and “will continue to pursue participation” from others, Teva said in a company statement. The two holdout states are Nevada and New Mexico, a Teva spokesperson told Fierce Pharma via email.”

India’s lax oversight of pharmaceutical manufacturing imperils health around the world The whole article is interesting, but this quotation stands out: “Unsafe drugs are just the tip of the iceberg. Substandard or ineffective drugs may be an even bigger problem.”
Comment: The reason this article is important is that India provides a large amount of the active pharmaceutical ingredients (APIs) and generic medications to the US and the rest of the world.

Chiesi Farmaceutici S.p.A. to Acquire Amryt Pharma Plc Highlights:
- Transaction expands Chiesi’s rare disease medicine portfolio
- All cash acquisition at US$14.50 per ADS, plus Contingent Value Rights of up to an additional US$2.50 per ADS based on certain Filsuvez® milestones being achieved
- Total Transaction value of up to US$1.48 Billion with upfront consideration representing a 107% premium to Amryt ADS’ closing price on January 6, 2023”

AstraZeneca buys US biotech CinCor in $1.8bn deal “AstraZeneca has agreed to buy US biotech CinCor in a deal worth up to $1.8 billion (€1.68 billion), as it seeks to expand its pipeline of heart and kidney drugs.”

About the public’s health

New guidance: Use drugs, surgery early for obesity in kids “Children struggling with obesity should be evaluated and treated early and aggressively, including with medications for kids as young as 12 and surgery for those as young as 13, according to new guidelines released Monday.
The longstanding practice of ‘watchful waiting,’ or delaying treatment to see whether children and teens outgrow or overcome obesity on their own only worsens the problem that affects more than 14.4 million young people in the U.S. Left untreated, obesity can lead to lifelong health problems, including high blood pressure, diabetes and depression…
For the first time, the group’s guidance sets ages at which kids and teens should be offered medical treatments such as drugs and surgery — in addition to intensive diet, exercise and other behavior and lifestyle interventions...”

 Weekly U.S. Influenza Surveillance Report Key Points

  • Seasonal influenza activity remains high but continues to decline in most areas.

  • Of influenza A viruses detected and subtyped during week 52, 70% were influenza A(H3N2) and 30% were influenza A(H1N1).

  • Thirteen influenza-associated pediatric deaths were reported this week, for a total of 74 pediatric flu deaths reported so far this season.

  • CDC estimates that, so far this season, there have been at least 22 million illnesses, 230,000 hospitalizations, and 14,000 deaths from flu.

  • The cumulative hospitalization rate in the FluSurv-NET system was 3.5 times higher than the highest cumulative in-season hospitalization rate observed for week 52 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.

  • The number of flu hospital admissions reported in the HHS Protect system was similar to last week.

  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

  • All viruses collected and evaluated this season have been susceptible to the influenza antivirals oseltamivir, peramivir, zanamivir, and baloxavir.”

About healthcare personnel

ADVISORY: NYSNA NURSES AT MOUNT SINAI HOSPITAL AND MONTEFIORE BRONX ON STRIKE Information from the NY State Nurses Association

 Healthcare adds 55K jobs in December, totaling 580K new roles since 2021, federal data show “Healthcare employment rose by 54,700 jobs in December with new roles in ambulatory care and hospitals, representing the strongest month of industry job gains since September’s 60,100, according to the U.S. Bureau of Labor Statistics’ (BLS') monthly report released Friday morning.
Ambulatory care services led the way with 29,900 new jobs, followed by hospitals adding 15,700 jobs and nursing and residential care facilities adding 9,100, according to BLS.”

About health technology

 Baxter International plans to spin off kidney care units “The company plans to spin off its renal care and acute therapies units into a separate listed entity in the next 12-18 months. It is also exploring alternatives for its biopharma solutions business, including a potential sale or other separation options.”

Today's News and Commentary

About Covid-19

NIH launches Home Test to Treat, a pilot COVID-19 telehealth program “The National Institutes of Health, in collaboration with the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has launched the Home Test to Treat program, an entirely virtual community health intervention that will provide free COVID-19 health services—at-home rapid tests, telehealth sessions and at-home treatments—in selected communities. The program, first announced by the White House in September 2022, will make antiviral treatment available for eligible individuals who receive a positive test result, which could prevent severe illness, hospitalization or death…
Later this month, local and state officials in Berks County, Pennsylvania, will be the first to pilot the Home Test to Treat program. Up to 8,000 eligible residents are anticipated to participate in the program.”

XAV-19, the anti-SARS-CoV-2 GH-pAb of XENOTHERA best-in-class against all variants including BQ. 1.1 “In the context of a major resurgence of the COVID epidemic, the French biotech XENOTHERA announces recent data in favor of the strong interest of its glyco-humanized polyclonal antibody (GH-pAb) XAV-19 to treat patients in the initial viral phase of the disease.
Several neutralization assays carried out by XENOTHERA have supplemented data already published... XAV-19 exhibits a strong neutralization activity against all omicron variants, including BQ.1.1, the main variant of SARS-CoV-2 in circulation to date. In the meantime, all monoclonal antibodies today marketed loose their activity against this variant. The neutralizing concentration of XAV-19 (IC50) is identical to that measured for all other variants of SARS-CoV-2.”

About health insurance/insurers

156M Beneficiaries Receive Health Insurance Through Public Programs “More than 150 million people receive health insurance through public programs, including Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), according to the latest enrollment data from CMS.
The data reflects enrollment in the programs as of September 2022.”

Health Insurance Providers Actions Concerning SDOH FYI

Which Parts of the United States Have the Most Consolidated Medicare Hospital Spending? Two hospital systems accounted for more than half of traditional Medicare inpatient hospital spending in 258 HRRs[hospital referral regions] and accounted for more than three-quarters of spending in 110 of the total 306 HRRs in the U.S.”
The maps also provide interesting information.

Long Island Medical Doctor Sentenced to 30 Months in Prison for Medicare Billing Fraud Scheme “From October 2015 through February 2020, the defendant submitted over $3 million in billings to Medicare for colonoscopy and gastroenterological procedures that were not performed.  Most of these billings indicated that the services were rendered to disabled beneficiaries, who were living in residential group homes.  Medicare reimbursed approximately $1.4 million of these false claims, none of which the defendant was entitled to receive.”

About hospitals and healthcare systems

 VillageMD completes $8.9B Summit Health buy “VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-City, MD Jan. 3, adding more than 2,800 providers to its ranks. 
News of the deal's completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.”

About pharma

FDA approves Alzheimer’s drug shown to moderately slow cognitive decline in early stages of the disease “The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.
Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it.”

U.S. new drug price exceeds $200,000 median in 2022 “The median annual price of the 17 novel drugs the U.S. Food and Drug Administration (FDA) approved since July 2022 is $193,900, down from $257,000 in the first half of 2022, Reuters found. For full year 2022, the median was $222,003.”
The article has a list and respective costs for these drugs.

Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS “Late this week, gene therapy player bluebird said it sold the second of two rare pediatric disease priority review vouchers (PRV) from the FDA for $95 million. The buyer, according to a bluebird securities filing, was pharma major Bristol Myers Squibb.”
Comment: The companies are less important than the latest “market value” for these vouchers.

BioNTech Announces Strategic Partnership with UK Government to Provide up to 10,000 Patients with Personalized mRNA Cancer Immunotherapies by 2030 Highlights:
-”Multi-year collaboration focuses on three strategic pillars: cancer immunotherapies, infectious disease vaccines, and expansion of BioNTech’s footprint in the UK
-BioNTech aims to design and roll out randomized clinical trials with registrational potential for the Company’s personalized mRNA cancer immunotherapies in the UK
-Accelerated clinical trial recruitment with first patient to be enrolled in a trial as part of this collaboration in H2 2023
-Set-up of an R&D hub in Cambridge (UK) with the aim to employ more than 70 highly skilled scientists with the first employees commencing work in Q1 2023”

About the public’s health

 South Carolina Supreme Court strikes down state abortion ban “The 3-2 decision comes nearly two years after Republican Gov. Henry McMaster signed the restriction into law. The ban after cardiac activity, which included exceptions for pregnancies by rape or incest or pregnancies that endanger the patient’s life, drew lawsuits almost immediately.
Justice Kaye Hearn, writing for the majority, said the state ‘unquestionably’ has the authority to limit the right of privacy that protects from state interference with the decision to get an abortion. But she added any limitation must afford sufficient time to determine one is pregnant and take ‘reasonable steps’ if she chooses to terminate that pregnancy.
’Six weeks is, quite simply, not a reasonable period of time for these two things to occur,’ Hearn added.”

Today's News and Commentary

About Covid-19

XBB.1.5's transmissibility, severity: 4 Qs answered “Maria Van Kerkhove, PhD, the WHO's COVID-19 technical lead…called it the ‘most transmissible subvariant that has been detected yet,’ due to mutations that allow it to adhere to the cell and replicate easily. Experts believe it has a growth advantage over its relative, XBB, which was already hailed as the most transmissible…
There's been no indication XBB.1.5. causes more severe disease than other omicron strains, though it's not completely certain yet…
It's not certain how well omicron boosters neutralize XBB.1.5, though more data is expected soon…”

Fla. surgeon general used ‘flawed’ vaccine science, faculty peers say “Joseph A. Ladapo, a professor of medicine at the University of Florida and the state’s surgeon general, relied upon a flawed analysis and may have violated university research integrity rules when he issued guidance last fall discouraging young men from receiving common coronavirus vaccines, according to a report from a medical school faculty task force.” The report ends with this statement: “In summary, the committee has concerns that Dr. Ladapo may have violated Sections 3.B.3 of the UF faculty policy on research integrity and has referred the matter to the University of Florida Research Integrity Officer (RIO).”

About health insurance/insurers

States Get New Pathway to Tackle Social Needs in Medicaid “States will be able to introduce initiatives addressing health-related social needs into their Medicaid managed care plans under guidance issued Wednesday by the Biden administration.
They will be able to offer alternative benefits that tackle social needs such as housing and food insecurity in an effort to help Medicaid enrollees maintain their coverage and improve their health outcomes.
The Centers for Medicare & Medicaid Services said it will allow managed care plans to pay for alternative benefits in lieu of more traditional services offered by state plans.”

 Humana laying off over 1,100 associates, shuttering all SeniorBridge locations “Humana is laying off at least 1,162 employees in two states following the decision to close all its SeniorBridge home care facilities nationwide.
The payer closed 16 facilities at the end of 2022, and said it plans to close its remaining seven locations in New York by March 5…
Humana purchased SeniorBridge in 2012 to manage chronic and home care services for predominantly seniors.”

BLUE CROSS BLUE SHIELD COMPANIES FORM SYNERGIE MEDICATION COLLECTIVE, A NEW VENTURE TO RADICALLY IMPROVE AFFORDABILITY AND ACCESS TO COSTLY MEDICATIONS FOR MILLIONS OF AMERICANS “Announced today, Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.
Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people.”

About pharma

 Justice Dept.: Despite bans, abortion pills may be mailed to any state “The Justice Department has issued a legal opinion that the U.S. Postal Service may deliver abortion pills to people in states that have banned or sharply restricted the procedure, saying that federal law allows the mailing of the pills because the sender cannot know for sure whether the recipient would use them illegally…
The U.S. Postal Service had asked the Justice Department to say whether it would be legally allowed to deliver pills that could be used for abortion in a state where the procedure is outlawed. The response was a resounding yes.The Justice Department’s opinion — which was quickly condemned by antiabortion groups — does not change any state or federal laws. It hinges on the department’s interpretation of Section 1461 of the Comstock Act, a law originally passed in 1873 that governs how the Postal Service handles the delivery of contraception and items considered ‘obscene.’”

WALGREENS BOOTS ALLIANCE REPORTS FISCAL 2023 FIRST QUARTER RESULTS First quarter financial highlights

  • First quarter loss per share* was $4.31 compared to earnings per share (EPS*) of $4.13 in the year-ago quarter reflecting a $6.5 billion pre-tax charge recognized in connection with the previously announced opioid litigation settlement frameworks and certain other opioid-related matters

  • Adjusted EPS decreased 30.8 percent to $1.16, down 29.9 percent on a constant currency basis against strong growth of 53.1 percent in the year-ago quarter reflecting higher COVID-19 vaccine volumes

  • First quarter sales decreased 1.5 percent year-over-year, to $33.4 billion, up 1.1 percent on a constant currency basis; excluding the negative impact from AllianceRx Walgreens of 485 basis points and the positive contributions from U.S. Healthcare M&A of 280 basis points, sales growth was 3.2 percent on a constant currency basis

  • Invested $3.5 billion in debt and equity to support VillageMD's acquisition of Summit Health, which closed January 3, 2023, accelerating U.S. Healthcare segment sales and path to profitability

  • Sold 19.2 million shares of AmerisourceBergen common stock in November and December, with after-tax cash proceeds of $3 billion

About the public’s health

FDA accepts filing for AstraZeneca, Sanofi's RSV preventative nirsevimab “AstraZeneca and Sanofi said Thursday that the FDA accepted a filing seeking approval of nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The agency's target action date for the application is in the third quarter of 2023, although the companies noted that the regulator has committed to expedite its review.
Nirsevimab recently gained clearance in the EU, where it is marketed under the brand name Beyfortus, for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season. The approval by the European Commission was the first regulatory authorisation for the single-dose, long-acting antibody.”

Misdiagnosis Meets Overdiagnosis in the ER This Letter to the Editor responds to an article in The Wall Street Journal that claimed the study on diagnostic ER errors used faulty statistics. You should read it, as well as the referenced study.

About healthcare IT

 Trends in Ransomware Attacks on US Hospitals, Clinics, and Other Health Care Delivery Organizations, 2016-2021 “In this cohort study of 374 ransomware attacks, the annual number of ransomware attacks on health care delivery organizations more than doubled from 2016 to 2021, exposing the personal health information of nearly 42 million patients. During the study period, ransomware attacks exposed larger quantities of personal health information and grew more likely to affect large organizations with multiple facilities.”
Comment: Why have healthcare security measures not improved as much as other parts of IT systems? Their failures are the reason we cannot have unique patient identifiers.

About healthcare personnel

 U.S. Moves to Bar Noncompete Agreements in Labor Contracts “In a far-reaching move that could raise wages and increase competition among businesses, the Federal Trade Commission on Thursday unveiled a rule that would block companies from limiting their employees’ ability to work for a rival.
The proposed rule would ban provisions of labor contracts known as noncompete agreements, which prevent workers from leaving for a competitor or starting a competing business for months or years after their employment, often within a certain geographic area. The agreements have applied to workers as varied as sandwich makers, hair stylists, doctors and software engineers.”
We will need to see what the final rule looks like, but it could have a profound impact on healthcare professionals. For example, professionals need to be compensated for signing a non-compete agreement. If that arrangement can no longer exist, will payments drop? Or will employers need to start offering retention bonuses in lieu of non-compete clauses?

About health technology

 GE HealthCare rises 8% in market debut, eyes small deals “ GE HealthCare Technologies Inc's shares rose as much as 8.4% in their Nasdaq debut on Wednesday and its chief executive said the company was looking to do small acquisitions to boost its cardiology and oncology operations in the long term.
The company, which was spun off from conglomerate GE had opened 3% lower in its first day of trading and closed up 8% at $60.49.”

FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test “The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test (MCDBT) for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.
In findings from the THUNDER case-control study, OverC MCDBT demonstrated a 69.1% rate of sensitivity and 98.9% rate of specificity. In data from 308 patients with surgery-resectable lung cancer and 261 age- and sex-matched non-cancer controls published in 2021, the assay detected 52% to 81% of patients at disease stages IA to III with a specificity rate of 96% (95% CI, 93%-98%).
In a subgroup analysis of 115 participants, the assay identified nearly twice as many patients with cancer as those detected by ultradeep mutation sequencing analysis. The specificity rate was 100% (95% CI, 91%-100%).
Investigators will further validate the assay in prospective interventional studies in an asymptomatic population.” 

Today's News and Commentary

About health insurance/insurers

 Why is the NHS in its worst ever crisis?  This Financial Times article is an excellent summary of the multiple factors contributing to the ailing British healthcare system.

The 10 parties initiating 75 percent of out-of-network disputes “Ten parties have initiated 75 percent of all disputes involving out-of-network emergency and nonemergency items in services under the No Surprises Act's independent dispute resolution process, according to a recent CMS report. 
Many of the top top parties were large management companies, medical practices or revenue cycle management companies representing hundreds of individual practices, providers or facilities, according to the report.”

Medicare lost millions in savings due to spotty oversight: federal watchdog “A federal watchdog has found that Medicare lost out on millions of potential savings due to spotty oversight of the average sales price of medications, impacting how much Medicare Part B beneficiaries pay for coverage…
The Office of Inspector General (OIG) for the Department of Health and Human Services found in two reports released Tuesday that while the CMS has an established procedure to oversee data on the average sales price of medications, the agency lacks a process to review the manual analysis. Invalid or missing ASP data resulted in the CMS being unable to determine payment amounts for 8 percent of products between 2016 and 2020.”

About hospitals and healthcare systems

RURAL HOSPITALS AT RISK OF CLOSING “More than 600 rural hospitals – nearly 30% of all rural hospitals in the country – are at risk of closing in the near future.”
The article also discusses how commonly offered solutions will not save them. The authors suggest fair insurance company payments: “It would only cost about $3 billion per year to prevent closures of the at-risk hospitals and preserve access to rural healthcare services.”

National Hospital Flash Report: December 2022 Key Takeaways

  1. Hospital margins remained negative for 2022.
    Hospitals saw margins improve in November. However, median hospital margins remained negative for 2022 to date.

  2. Hospital expenses declined in November, driving improved margins.
    The average patient length of stay declined slightly—along with several other key volume metrics— leading to relatively flat revenue. However, hospital expenses declined, resulting in improved margins.

  3. Labor expenses decreased in November.
    Like in other industries, significant increases in the cost of labor made it harder for hospitals to see positive margins in 2022. In November, however, hospitals saw labor expenses decrease, potentially due to hospitals relying less on contract labor, which is often more expensive.

  4. Hospital outpatient revenue is up this year.
    Hospital outpatient clinics and services have been a bright spot in hospitals’ revenue column in 2022. While inpatient service continue to hamper margins, hospitals could lean on their outpatient services to buoy margins.”

About pharma

 PBMs Announce 2023 Coverage Plans for Adalimumab Biosimilars “AbbVie’s Humira, which treats multiple inflammatory diseases, had sales that nearly reached $21 billion in 2021. The only more profitable medication that year was Pfizer’s COVID-19 vaccine. But with the first adalimumab biosimilar, Amgen’s Amjevita, launching in January 2023 followed by at least 7 more—including Boehringer Ingelheim’s Cyltezo, which is the only approved adalimumab biosimilar to have interchangeability—Humira’s reign is likely about to come to an end.
In addition to the 8 approved biosimilars, there are another 2 under review with the FDA. One of these biosimilars, AVT02, has an application for interchangeability under review. AVT02 would be the first interchangeable, high-concentration adalimumab biosimilar when it is approved.”

FDA says it will greenlight pharmacies to fill prescriptions for abortion pill “The abortion pill mifepristone is safe enough that retail pharmacies can begin dispensing it so long as a certified health care provider prescribes the drug and if that pharmacy meets certain requirements, according to new rules published Tuesday by the U.S. Food and Drug Administration.”

Allscripts Announces Corporate Name Change to Veradigm Inc. “Allscripts Healthcare Solutions, Inc. announced today that, effective January 1, 2023, it has changed its name to Veradigm Inc. Allscripts had been transitioning its solutions to the Veradigm brand during 2022, and Allscripts will now formally be known as Veradigm.”

Comparison of Opioids Prescribed by Advanced Practice Clinicians vs Surgeons After Surgical Procedures in the US “In this cross-sectional analysis, one-fifth of perioperative opioid prescriptions and one-quarter of refill prescriptions were written by APCs. While surgeons wrote most perioperative opioid prescriptions that were intended for perioperative analgesia, higher total dosages from APCs suggest that opioid stewardship initiatives that support the role of APCs may be warranted.”

About healthcare IT

Association of Habitual Checking Behaviors on Social Media With Longitudinal Functional Brain Development “These results suggest that habitual checking of social media in early adolescence may be longitudinally associated with changes in neural sensitivity to anticipation of social rewards and punishments, which could have implications for psychological adjustment.”
I am reminded of the John Price song Spanish Pipedream, which included in the refrain:
“Blow up your TV
Throw away your paper
Go to the country
Build you a home…”
In the same issue of JAMA Pediatrics is: Physical Activity Interventions to Alleviate Depressive Symptoms in Children and AdolescentsA Systematic Review and Meta-analysis “The available evidence supports physical activity interventions as an alternative or adjunctive approach to alleviate depressive symptoms in children and adolescents, substantiating the beneficial influence of physical activity on the mental health of pediatric populations.”
In other words, get off your computer/smart phone and exercise! Good advice for adults as well.

Samsung's New Telemedicine App, Camera Aims to Give Your TV Telehealth Powers “After users choose from a list of symptoms and input how long they've been ill, the app "will show relevant available doctors." Samsung will then create a link between the doctor and the at-home patient. The company says its service will ‘generally’ connect a doctor ‘within 60 seconds.’
After being connected, the doctor will be able to ‘conduct an exam through video conferencing via the app’ using a camera attached to the TV. The app can also integrate with other devices beyond the TV including Samsung's own Galaxy Watch. After the exam is over, Samsung says that users will not only be able to rate their experiences but also schedule a follow-up appointment, have a prescription filled remotely including having it ‘delivered directly to their doorstep all via the on-screen app.’

Today's News and Commentary

About Covid-19

 Highly immune evasive omicron XBB.1.5 variant is quickly becoming dominant in U.S. as it doubles weekly “KEY POINTS
The Covid omicron XBB.1.5 variant has nearly doubled in prevalence over the past week and now represents about 41% of new cases in the U.S., according to CDC data.
XBB.1.5 is highly immune evasive and appears to bind better to cells than other members of the XBB omicron subvariant family.
Scientists at Columbia University have warned that the rise of subvariants such as the XBB family could ‘result in a surge of breakthrough infections as well as re-infections.’”

About health insurance/insurers

CMS cracks down on Medicare Advantage TV marketing “CMS is cracking down on deceptive marketing practices and will no longer allow Medicare Advantage or Part D prescription drug plans to advertise on television without agency approval first.
The new policy is effective Jan. 1, 2023 and was discussed in an Oct. 19, 2022 memo from CMS to MA and Part D providers. The agency said it issued the new policy after reviewing thousands of beneficiary complaints regarding confusing, misleading or inaccurate information from plans — plan sponsors are also responsible for all marketing activities from brokers and third-party agencies….
To ensure compliance during the ongoing open enrollment period, CMS will review all marketing materials received during the period and target its oversight toward organizations with high rates of complaints. It will also monitor broker calls with potential enrollees and continue to ‘secret shop.’”

Medical bills heading to dispute resolution far more often than anticipated “Insurers and providers are overwhelming an arbitration system Congress set up to resolve billing disputes as part of the law to prevent surprise medical bills, according to CMS data
Federal agencies estimated there would be 17,333 claims a year submitted to the independent dispute resolution process.
But, CMS data shows, there were more than 90,000 disputes initiated in less than six months.
Determining which disputes are eligible for review is taking longer than anticipated as well, CMS officials said in the report.”

Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Cigna-HealthSpring of Tennessee, Inc. (Contract H4454) Submitted to CMS “With respect to the 10 high-risk groups covered by our audit, most of the selected diagnosis codes that Cigna submitted to CMS for use in CMS’s risk adjustment program did not comply with Federal requirements. For 195 of the 279 sampled enrollee-years, the medical records that Cigna provided did not support the diagnosis codes and resulted in $509,194 in overpayments.
As demonstrated by the errors found in our sample, Cigna’s policies and procedures to prevent, detect, and correct noncompliance with CMS’s program requirements, as mandated by Federal regulations, could be improved. On the basis of our sample results, we estimated that Cigna received at least
$5.9 million in overpayments for 2016 and 2017.”
This review is part of the OIG’s program to review appropriateness of coding for all MA plans. Read the article for proposed remedies.

About pharma

 Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit “Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements.
The Swiss pharma will pay altogether $245 million in separate settlements with direct purchasers, indirect purchases and retailers who had accused the company of colluding with Endo’s Par Pharmaceutical to push back the launch of a generic version of Novartis’ high blood pressure med Exforge.”

Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021 “Manufacturers of brand-name inhalers listed many more secondary patents than primary patents with the FDA from 2000 to 2021 and earned substantially more revenue on inhalers after active ingredients went off patent compared with revenue generated when the primary patents remained active…
The current patent and regulatory system rewards minor changes to the delivery systems of existing molecules, diverting incentives for investments in new therapeutic breakthroughs.2 Regulators and lawmakers have begun to scrutinize patenting practices relating to drug-device combinations.5,6 Without substantial reform, patients and payers may continue spending large sums on inhaled products with active ingredients developed decades ago.”

96 drugs lost exclusivity in 2022 FYI

2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37 FYI

About healthcare personnel

 The US doesn’t have enough infectious disease doctors — and the situation is about to get worse.  “According to Association of American Medical Colleges data and a 2017 IDSA survey, ID doctors who care for patients make around $175,000 to $215,000 annually — which doesn’t go as far as you’d think given most US doctors’ are hundreds of thousands of dollars in educational debt. It’s also less than half of what some other specialties earn.”

Today's News and Commentary

To all readers,

Thanks so much for your interest this past year.
I wish you all the best for a happy and healthy New Year.

Joel

About health insurance/insurers

 Medical Debt Is Being Erased in Ohio and Illinois. Is Your Town Next?  “Cook County, Ill., and Toledo, Ohio, are turning to the American Rescue Plan to wipe out residents’ medical debt. Experts caution it is a short-term solution….
More local governments are likely to follow as county executives and city councils embrace a new strategy to address the high cost of health care. They are partnering with RIP Medical Debt, a nonprofit that aims to abolish medical debt by buying it from hospitals, health systems and collections agencies at a steep discount.”

About pharma

 Insulin costs will be capped in 2023, but most people with diabetes won't benefit The article highlights the fact that Republicans blocked price controls for insulin that will become for Medicare beneficiaries in the new year.

AmerisourceBergen Hit With Federal Lawsuit Over Opioid Crisis “The Justice Department has sued AmerisourceBergen Corp., alleging the large drug distributor contributed to the prescription opioid epidemic by failing to report suspicious orders to law enforcement.
Associate Attorney General Vanita Gupta said during a news conference Thursday that AmerisourceBergen could face billions of dollars in civil penalties if found liable in the lawsuit, filed in federal court in Philadelphia.”
For readers who are physicians, this article, published earlier this month, should be of interest:The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

About the public’s health

 A Study Sounds a False Alarm About America’s Emergency Rooms This Wall Street Journal Op-ed article critiques the methodology that AHRQ used to project that 250,000 deaths occurred per year due to ER errors.
See, also: No, ER misdiagnoses are not killing 250,000 per year 

Today's News and Commentary

About Covid-19

 Wisconsin Supreme Court to hear ivermectin treatment case “The Wisconsin Supreme Court will determine whether a court can compel a hospital to provide ivermectin as treatment for COVID-19. 
A Dec. 23 article published on the AMA website detailed a lawsuit filed against a Wisconsin hospital. After a patient was forced to be intubated, the patient's nephew tried to compel physicians to give his uncle ivermectin, a treatment experts say is ineffective against COVID-19. His uncle has since recovered and was released from the hospital…
Wisconsin law does not require physicians to provide treatment that medical evidence suggests will not benefit patients and may cause harm, the brief said. Ivermectin is not approved or recommended by the CDC or FDA for treating COVID-19, and the National Institutes of Health, World Health Organization and the drug's manufacturer, Merck, say there is insufficient evidence to support using ivermectin to treat COVID-19.”
My non-legal opinion is that the court will dismiss the case outright in favor of physician judgement and federal approval of treatments. On the other hand it may sidestep the issue and dismiss the case, saying that it is moot because the patient recovered and does not need currently require treatment.
Imagine the consequences if the court rules for the plaintiff…bring in the leaches!

About health insurance/insurers

Cost-Sharing Reform for Chronic Disease Treatments as a Strategy to Improve Health Care Equity and Value in the US  The authors make the point that out-of-pocket expenses are not likely to reduce demand, since those with chronic diseases need the treatments. Further, cost sharing can only hurt- contributing to lower compliance due to high expenses.

Performance of Physician Groups and Hospitals Participating in Bundled Payments Among Medicare Beneficiaries Findings  This cohort study with a difference-in-differences analysis found that physician group practices participating in bundled payments had associated savings with surgical but not medical episodes, whereas participating hospitals had savings associated with both episode types.
Meaning  The findings of this cohort study suggest that policy makers should consider the comparative performance of participant type when designing and evaluating future bundled payment models.”

Beneficiary Switching Between Traditional Medicare and Medicare Advantage Between 2016 and 2020 “While switching rates from MA to TM exceeded those for TM to MA in 2016, this pattern was reversed from 2017 through 2020. In 2020, TM-to-MA switching rates were almost 4 and 2.5 times higher than switching rates from MA to TM for Medicare only and Medicare-Medicaid enrollees, respectively. As a result, switching accounted for a growing share of new MA enrollment growth, increasing from 49% in 2016 to 67% in 2020.
While switching rates were not substantively different by sex, they generally declined with age. Switching patterns by mortality status also changed materially. In 2016, beneficiaries in their last year of life were more than twice as likely to disenroll from MA than from TM (5.4% vs 2.6%). By 2020, the trend had reversed (3.1% vs 5.1%).
Black and Hispanic beneficiaries generally switched at greater rates than White beneficiaries, and these differences have become more pronounced and were associated with the shift from TM to MA. By 2020, Black and Hispanic beneficiaries were more than twice as likely to disenroll from TM as White beneficiaries (13.4% and 13.5%, respectively, vs 5.9%). These switching patterns also persisted for beneficiaries during the last year of life.”
As MA is expected to exceed 50% of national Medicare enrollment next year, these findings are somewhat reassuring.

About hospitals and healthcare systems

 INCREASE IN LENGTH OF STAY ADDS TO HOSPITALS' FINANCIAL STRAIN “To increase collections and build a stronger, more positive relationship with patients amid these struggles, revenue cycle leaders are putting the spotlight on the patient experience, but as staffing shortages hit organizations’ hard and patients’ length-of-stay grow, these goals seem more unattainable.
The average length-of-stay in hospitals has increased by about 19% for patients in 2022 compared to 2019, according to data from the healthcare consulting firm Strata Decision Technology.
These delays in hospitals’ ability to discharge patients, as well as the negative consequences on both patients and hospitals, was stressed in a recent report released by the American Hospital Association (AHA).” 

About pharma

 House investigation faults FDA, Biogen for Alzheimer’s drug approval A good summary of the Aduhelm fiasco: “ The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees.”
Also, see: FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation  

About health technology

 Trade Commission Sides with AliveCor, Orders Halt in Imports of Certain Apple Watches “The U.S. International Trade Commission (ITC) has affirmed its June initial decision and has once again sided with AliveCor that Apple infringed on AliveCor’s wearable electrocardiogram (ECG) device patents, potentially halting importation of certain Apple watches.
The cease and desist order sets a bond of $2 per unit of infringing Apple watches imported or sold during the required 60-day period during which President Biden must review the decision. If President Biden takes no action, the ITC’s final ruling will stand.”

About healthcare finance

 10 biggest health funding rounds of 2022 FYI

10 largest hospital groups and their 2022 credit ratings  FYI

Biggest health deals of 2022 FYI
Biggest is not always wisest. let’s look at these over the next year.

Today's News and Commentary

About Covid-19

U.S. imposes Covid testing requirements on travelers from China “The United States will require all travelers from China to show a negative Covid-19 test before boarding flights to the U.S., federal health officials announced Wednesday, citing concerns about a surge of Covid infections in China and a lack of transparency from Chinese government officials about how widespread that country’s outbreak is…
The new rules apply to all travelers over two years old, including American citizens, and applies to all travelers regardless of vaccination status. It also applies to travelers who transit through China on their way to the U.S. The new requirements will take effect at 12:01 a.m. ET on Jan. 5, to give airlines time to implement them.”
Comment: Why did the US take so long to impose the requirement and, once policy is set, why delay implementation? It only takes one plane to come with a few travelers infected with a new strain to rekindle our pandemic. Further, given the unreliability of Chinese data, all such travelers should be required to have a negative test at the US entry point.
As has been said before: Science + Politics= Politics

About health insurance/insurers

 HealthCare.gov Sign Ups Outpace Previous Years At Key Milestone An update FYI: “…Affordable Care Act (ACA) Marketplace enrollment continues to outpace previous years, with nearly 11.5 million people selecting a health plan nationwide as of December 15, 2022 – a key milestone marking the deadline for coverage starting January 1, 2023. About 1.8 million more people have signed up for health insurance, or an 18% increase, from this time last year.”

These states tried an Obamacare public option. It hasn’t worked as planned. “The public option envisioned by liberals during the Obamacare debate was a government-run insurance plan that would compete in the private market. That’s not what Colorado, Nevada and Washington are doing. Instead, they are using their regulatory authority to influence what private insurance companies offer.
Democrats view this new public option concept as one tool among many — including reinsurance programs, state subsidies, rate review programs, and coverage expansions to undocumented immigrants — to expand health insurance access.
But costs have not come down enough yet to make a real dent in affordability or in the rates of uninsured and underinsured.”

About pharma

 50 drugs on Mark Cuban's pharmacy with biggest cost reductions When evaluating articles like this one, you have to make sure you are comparing the same dosing (number of pills per dose), pill strength and number of pills per prescription, e.g., 30 or 90 day supplies.
That said, I looked up some of these drugs on both the Mark Cuban website and GoodRx. Two advantages were apparent using the former site. First, the drugs were cheaper than on GoodRx. Second, some of the drugs (see 1. and 4. on the article’s list, for examples) are only available from specialty pharmacies, not the retail outlets GoodRx promotes. So only the Mark Cuban site is available for a discount.
One more caveat: It may be cheapest, if you have insurance, to go through their contracted retail/specialty pharmacy.
Considering high cost and chronic drugs, it’s worth the time to investigate.

 Misleading Ads Fueled Rapid Growth of Online Mental Health Companies An excellent piece of investigative journalism by The Wall Street Journal. Such ads aren’t limited to mental health, but span the healthcare field. Well worth reading, even if you have kept up with the Cerebral scandal, which goes back more than a year.

About the public’s health

 Weekly U.S. Influenza Surveillance Report From the CDC: “Key Points
Seasonal influenza activity remains high but is declining in most areas.
Of influenza A viruses detected and subtyped during week 50, 77.8% were influenza A(H3N2) and 22.2% were influenza A(H1N1).
Seventeen influenza-associated pediatric deaths were reported this week, for a total of 47 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 18 million illnesses, 190,000 hospitalizations, and 12,000 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system was more than 6 times higher than the highest cumulative in-season hospitalization rate observed for week 50 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-11.”

FDA, Concerned About Safety, Explores Regulating CBD in Foods, Supplements “The Food and Drug Administration is studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months, agency officials said.”

Today's News and Commentary

About Covid-19

 52% of Americans think COVID-19 PHE still needed “Fifty-two percent of Americans think a public health emergency should still be in effect for COVID-19, according to a new survey from Morning Consult. 
Morning Consult conducted the survey from Dec. 14-19 with 2,210 adults, posting the question, "In your opinion, do you think a public health emergency should be in effect currently for COVID-19?" 
Responses broke down as follows: 

  • Yes, definitely: 23 percent 

  • Yes, probably: 29 percent 

  • No, probably not: 21 percent

  • No, definitely not: 17 percent 

  • Don't know or no opinion: 10 percent”

About health insurance/insurers

Trends in Reported Health Care Affordability for Men and Women With Employer-Sponsored Health Insurance [ESI] Coverage in the US, 2000 to 2020 “A higher proportion of women than men with ESI reported that they were unable to afford needed health care, although the proportion experiencing unaffordability was low except for dental care. Lower income and higher health care needs among women could be driving sex differences in reported affordability. For both women and men, the trends (for most services) changed from increasing unaffordability to decreasing and then to increasing again. Although the Affordable Care Act extended ESI coverage to uninsured young adults through its dependent coverage provision, eliminated cost sharing for preventive services, and implemented maternal care coverage, rising health care costs, growth in high-deductible plans, and increased out-of-pocket health care expenditures may have contributed to increased unaffordability in recent years.”

Humana, TriWest tapped for $136B Tricare managed care contracts “Humana Military and TriWest Healthcare Alliance have been awarded the Defense Department's Tricare managed care support contracts. 
Humana Military was awarded the $70.9 billion East Region contract, according to a Dec. 22 news release from the department. This is the sixth time Humana has been selected for a Tricare contract dating to 1996, according to a news release from the company. 
TriWest Healthcare Alliance was awarded the $65.1 billion West Region contract, according to the Defense Department release…
The new contracts begin in 2024, according to the Defense Department. The nine-year contracts are the longest in the program's history, according to Humana.”

About hospitals and healthcare systems

 Big Nonprofit Hospitals Expand in Wealthier Areas, Shun Poorer Ones  A really good investigative journalism piece from The Wall Street Journal.
"
Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades.
As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.
Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them.”

About pharma

 FDA grants fast-track review for over-the-counter overdose drug “The nonprofit pharmaceutical company Harm Reduction Therapeutics on Monday said in a release the FDA had granted it priority review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment.” 

About healthcare IT

Philadelphia-area Company To Pay $45 Million Whistleblower Settlement For Outsourcing Heart Monitoring To India “A Philadelphia region company has agreed to pay $44.875 million to settle allegations that it defrauded U.S. taxpayers by outsourcing critical remote medical services to technicians in India who were not properly trained.
The fraud allegations against Malvern, Pa.-based BioTelemetry, Inc., now a Royal Philips company, emerged through a whistleblower lawsuit brought by Ross Feller Casey, LLP, of Philadelphia, on behalf of former company employees.”

About healthcare personnel

 Trends in Labor Unionization Among US Health Care Workers, 2009-2021 “In this cross-sectional study of 14 298 US health care workers, the prevalence of reported labor unionization was 13.2%, with no significant change from 2009 through 2021. Reported membership or coverage by a labor union was significantly associated with higher weekly earnings and better noncash benefits but greater number of weekly work hours.” 

Today's News and Commentary

The Senate passed the omnibus budget bill, which now goes to the House. The Washington Post has a really good summary of what’s in the legislation.  

About pharma

 Gilead scores FDA okay for twice-yearly HIV drug Sunlenca “Gilead Sciences said Thursday that the FDA has approved its long-acting HIV-1 capsid inhibitor Sunlenca (lenacapavir) for patients with multi-drug resistant HIV infection. The drug, which was cleared by EU regulators in August, ‘offers a new twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen,’ the company said.”

About the public’s health

 MITRE-Harris Poll: Many Patients Feel Ignored or Doubted When Seeking Medical Treatment “A new MITRE-Harris Poll Survey on Patient Experience finds 52 percent of individuals in the United States feel their symptoms are ‘ignored, dismissed, or not believed’ when seeking medical treatment. That number rises to 6-in-10 within the Hispanic community.  
The polling also revealed that more than half of Blacks and Hispanics feel the ‘healthcare provider is biased against me based on their attitude, words, or actions,’ contributing to a 4-in-10 average across all demographics. Fifty percent (50%) of respondents also reported “a healthcare provider assuming something about me without asking me.”