Today's News and Commentary

About Covid-19

 Long COVID: What Do the Latest Data Show? “The percentage of people who have had COVID and currently report long COVID symptoms declined from 19% in June 2022 to 11% in January 2023.”
Read the KFF report for more information. 

About health insurance/insurers

 FTC unlikely to challenge UnitedHealth-LHC Group deal: report “The Federal Trade Commission is not expected to challenge UnitedHealth Group's acquisition of home health firm LHC Group, Seeking Alpha reported Jan. 31, citing a CTFN report. 
The news comes after Capitol Forum reported Jan. 26 that the FTC was reviewing the planned acquisition under a ‘potential vertical harm theory.’ CTFN said in its report that legal arguments about vertical theories of harm are unlikely to effectively halt the deal. 

Humana Reports Fourth Quarter 2022 Financial Results; Provides Full Year 2023 Financial Guidance —“Reports 4Q22 loss per share of $0.12 on a GAAP basis, Adjusted EPS of $1.62; reports full year (FY) 2022 EPS of $22.08 on a GAAP basis, $25.24 on an Adjusted basis
—Announces FY 2023 EPS guidance of at least $27.57 on a GAAP basis; at least $28.00 on an Adjusted basis
—Affirms strong 2023 individual Medicare Advantage membership growth of at least 625,000, or 13.7 percent growth over FY 2022 ending membership; anticipates growth to be meaningfully higher than the industry growth…”

CVS Health goes live with virtual care service with a focus on primary care, mental health “As part of its new virtual primary care service, CVS Health is expanding telehealth-based mental health care to include appointments with licensed therapists and psychiatrists. 
The retail drugstore giant announced its virtual care offering last May to give consumers access to primary care, on-demand care, chronic condition management and mental health services.”

Two large cases of health fraud prosecuted by the DOJ (both involve DME):
Three Men Indicted in San Antonio on Charges Related to $14.5 Million Healthcare Fraud Scheme “According to court documents, Kuba Zarobkiewicz, 35, of San Antonio, and Anthony Fermin, 32, of Boca Raton, Florida, own various medical equipment companies and pharmacies involved in a scheme to defraud Medicare by paying kickbacks to telemarketing firms owned and operated by Farrukh Mirza, 39, of Richmond, Texas, in exchange for signed doctor’s orders issued for unnecessary hip, knee and back braces.”

Two Florida Doctors Convicted in $31 Million Medicare Fraud Scheme "According to court documents and evidence presented at trial, Dean Zusmer, 54, of Miami, was a chiropractor who conspired with others to steal millions of dollars from Medicare. Zusmer owned one of four DME companies that collectively billed Medicare over $31 million for medically unnecessary DME, of which over $15 million was paid. Zusmer and his co-conspirators, including Jeremy Waxman, acquired patient referrals and signed doctors’ orders by paying kickbacks to marketers who used overseas call centers to solicit patients and telemedicine companies to procure prescriptions for unnecessary braces for these patients.”

About hospitals and healthcare systems

Association of Hospital Quality and Neighborhood Deprivation With Mortality After Inpatient Surgery Among Medicare Beneficiaries “Findings  In this cross-sectional review of 1 898 829 Medicare beneficiaries undergoing 1 of 5 common surgical procedures, patients from the least deprived neighborhoods going to high-quality hospitals had a 3.9% probability of postoperative mortality compared with 8.1% among patients from the most deprived neighborhoods going to low-quality hospitals, a significant difference.
Meaning  These findings suggest that the scope of hospital-driven efforts and investments to minimize disparities in postoperative mortality should include attention to factors associated with socioeconomic deprivation in the communities where patients live.”

About pharma

 Moderna's RSV Vaccine Snags FDA Breakthrough Therapy Nod “The FDA granted Moderna's RSV vaccine candidate Breakthrough Therapy Designation … based on the pivotal Phase III ConquerRSV trial, in which the mRNA-based vaccine, mRNA-1345, demonstrated 83.7% efficacy against RSV lower respiratory tract disease in older adults.”

GoodRx pays $1.5 million to settle health privacy allegations “U.S. healthcare firm GoodRx Holdings has agreed to pay $1.5 million to settle allegations that it failed to notify customers that it shared personal health information with Alphabet's Google, Meta's Facebook and others, the Federal Trade Commission said on Wednesday.
Under the terms of the settlement, GoodRx will be barred from sharing user health data with other companies to use for advertising.”

Nearly 1K drug prices rose in January “So far in 2023, pharmaceutical companies have raised prices on 988 brand-name drugs for an average 5 percent wholesale acquisition cost increase, according to 46brooklyn Research, a nonprofit that tracks drug pricing data. 
This is the highest number of January drug price increases since 2011, its dashboard shows. More than 600 of them don't have generic alternatives.”

3 companies report 4thQ sales and projections:
Amgen's Q4 profit slides, as sales tick above estimate
Novartis posts drop in Q4 sales, profit ahead of Sandoz spin-off
Shrinking demand for COVID products expected to cut Pfizer sales by 30% this year

About the public’s health

 FDA creates food safety, nutrition program in wake of baby formula crisis “The Food and Drug Administration will create a senior position to oversee food safety and nutrition after recent foodborne-illness crises, including a baby formula shortage, exposed major flaws in the agency’s structure and culture.” 

About healthcare finance

KKR veteran sets records with $3.9 billion health care fund “The former head of health care investing at private equity giant KKR has set records with the first fundraising for his new firm.
The firm, Patient Square Capital, closed on $3.9 billion for its fund Wednesday. That makes it the largest inaugural fund for a new U.S.-based private equity firm. The previous record was set by Centerbridge Partners’ $3.2 billion fundraising in 2006, according to data from PitchBook."

Today's News and Commentary

U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes
Latest international comparisons from The Commonwealth Fund. The headline sums it up.
“Highlights
—Health care spending, both per person and as a share of GDP, continues to be far higher in the United States than in other high-income countries. Yet the U.S. is the only country that doesn’t have universal health coverage.
—The U.S. has the lowest life expectancy at birth, the highest death rates for avoidable or treatable conditions, the highest maternal and infant mortality, and among the highest suicide rates.
—The U.S. has the highest rate of people with multiple chronic conditions and an obesity rate nearly twice the OECD average.
—Americans see physicians less often than people in most other countries and have among the lowest rate of practicing physicians and hospital beds per 1,000 population.
—Screening rates for breast and colorectal cancer and vaccination for flu in the U.S. are among the highest, but COVID-19 vaccination trails many nations.”

About Covid-19

 $5.4 billion in covid aid may have gone to firms using suspect Social Security numbers “The U.S. government may have awarded roughly $5.4 billion in coronavirus aid to small businesses with potentially ineligible Social Security numbers, offering the latest indication that Washington’s haste earlier in the pandemic opened the door for widespread waste, fraud and abuse.
The top watchdog overseeing stimulus spending — called the Pandemic Response Accountability Committee, or PRAC — offered the estimate in an alert issued Monday and shared early with The Washington Post. It came as House Republicans prepared to hold their first hearing this week to study the roughly $5 trillion in federal stimulus aid approved since spring 2020.”

5 impacts of ending COVID emergency “1) Reduced Medicaid & CHIP health coverage 2) Telehealth more difficult 3) Reduced access to free tests & treatments 4) Hobbles CDC surveillance 5) Public messaging undermined”

About health insurance/insurers

Feds expect to collect $4.7B in insurance fraud penalties More on yesterday’s CMS audit announcements regarding Medicare Advantage plans.
"The Biden administration estimated Monday that it could collect as much as $4.7 billion from insurance companies with newer and tougher penalties for submitting improper charges on the taxpayers’ tab for Medicare Advantage care.
Federal watchdogs have been sounding the alarm for years about questionable charges on the government’s private version of the Medicare program, with investigators raising the possibility that insurance companies may be bilking taxpayers of billions of dollars every year by claiming members are sicker than they really are to receive inflated payments.
The Department of Health and Human Services said it will begin collecting payments from insurers when an audit turns up that they charged for diagnoses that are not reflected in the patient’s medical records. The government has not sought refunds for those payments in over a decade, the agency said.”

 CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities “CVS Health has created the Community Equity Alliance, an initiative aimed at addressing barriers to care in underserved communities.
The initiative, launching this month, was established to help make healthcare more accessible and to decrease health disparities. The first institutions to join the initiative are Meharry Medical College, Sinai Chicago and Wayne State University, which will, among other efforts, gather and share data with CVS Health on local community needs.”

CMS Announces ACA Special Enrollment Period during PHE Unwinding “CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.”

About pharma

 Amgen's Humira biosimilar Amjevita hits the market with two different list prices “California-based Amgen is offering the first U.S. Humira biosimilar at two different price points—one 55% below Humira's list price and the other at a 5% discount. Humira's U.S. list price is $6,922 per month, Reuters reports.
While the 55% discount looks good on paper, the more expensive product might end up being more popular with payers because of rebate dynamics.”

About healthcare IT

CMS IMPROVES MEDICAID REIMBURSEMENT FOR DIGITAL HEALTH CONSULTS “KEY TAKEAWAYS
The Centers for Medicare & Medicaid Services has issued new guidance on Medicaid and CHIP coverage for eConsults, or interprofessional consultations between a primary care provider and a specialist on treatment for a specific patient.
Under the new guidance, specialists are able to bill Medicaid for eConsults rather than primary care providers, who would often have to bill higher rates so that they could reimburse specialists for their services.
The platform is popular with primary care providers who want to keep more of their patients and specialists who want to expand their reach, while it improves access to care for underserved populations who can't afford or won;t travel to see a specialist.”

 Russian hackers disrupt health system websites across US “Russian hacking group Killnet claimed responsibility for a cyberattack that disrupted hospital and health system websites across the U.S., according to BetterCyber, a technology company.”
The article has a list of affected hospitals.

About healthcare personnel

 11 medical schools boycott US News rankings: Who, why and what's next The list is slowly growing. Still not at an inflection point.

Today's News and Commentary

About Covid-19

Biden to end covid health emergencies on May 11 “President Biden informed Congress on Monday that he will end the national emergencies to combat the covid outbreak on May 11, a move that will restructure the federal government’s response to the pandemic nearly three years after the virus first arrived in the United States.”

COVID DATA TRACKER WEEKLY REVIEW “As of January 25, 2023, the current 7-day average of weekly new cases (42,163) decreased 11.3% compared with the previous 7-day average (47,515). A total of 102,171,644 COVID-19 cases have been reported in the United States as of January 25, 2023.” 

[WHO] Statement on the fourteenth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic “The WHO Director-General concurs with the advice offered by the Committee regarding the ongoing COVID-19 pandemic and determines that the event continues to constitute a public health emergency of international concern (PHEIC). The Director-General acknowledges the Committee’s views that the COVID-19 pandemic is probably at a transition point and appreciates the advice of the Committee to navigate this transition carefully and mitigate the potential negative consequences.”

About health insurance/insurers

CMS issues final rule on Medicare Advantage risk adjustment The Centers for Medicare and Medicaid Services has finalized risk adjustment policies in a final rule to prevent overpayments to Medicare Advantage Organizations.
Rather than applying extrapolation beginning for payment year 2011 audits as CMS initially proposed, the agency has finalized a policy not to extrapolate RADV [Risk Adjustment Data Validation] audit findings for payment years 2011-2017 and begin extrapolation with the 2018 RADV audit. 
As a result, CMS will only collect the non-extrapolated overpayments identified in the CMS RADV audits and OIG audits between payment years 2011 and 2017.
The rule finalizes a proposed policy that CMS will not apply an adjustment factor, known as an Fee-for-Service Adjuster, in RADV audits.”

 What Happens After People Lose Medicaid Coverage? “Key findings include:

• In the year following a disenrollment from Medicaid/CHIP, roughly two-thirds (65%) of people had a period of uninsurance.

• Roughly four in ten (41%) people who disenrolled from Medicaid/CHIP eventually re-enrolled in Medicaid/CHIP within a year …”

About hospitals and healthcare systems

National Hospital Flash Report “Key Takeaways

1. Hospital margins end year in difficult shape.

   Despite modest margin improvements in November and December, suggesting a positive trendline heading into the new year, 2022 was the worst financial year since the start of the pandemic. Approximately half of U.S. hospitals finished the year with a negative margin as growth in expenses outpaced revenue increases.

2. Financial pressures driven by labor expenses.

   Hospitals faced prolonged increases in labor expenses last year. The increases were driven in part by a competitive labor market, as well as hospitals needing to rely on more expensive contract labor to meet staffing demands. Increased lengths of stay due to a decline in discharges also negatively affected hospital margins.

3. Outpatient settings see increased volume.

   The front door of the hospital continues to shift away from the emergency department. Hospitals experienced increased outpatient volumes, including in surgical settings.

4. Success in 2023 tied to learning lessons of '22.

   Expense pressures are unlikely to recede in 2023. Hospitals that embrace better workforce management strategies, secure more stable supply lines, and more effectively negotiate with payers are likely to have better financial years in 2023. Hospitals should also leverage their outpatient footprint and improve relationships with post-acute settings to maximize current patient volume trends.”

 Why urgent care centers are popping up everywhere A good review if the status these facilities. One disturbing statistic: “One urgent care industry magazine says, in 2009, 70% of its providers were physicians, but that the percentage had fallen to 16% by last year.”

About pharma

J&J Can’t Use Bankruptcy to End Cancer Suits Over Baby Powder, Court Says “Johnson & Johnson can’t use bankruptcy to resolve more than 40,000 cancer lawsuits over its baby powder, a federal appeals court ruled. 
The three-judge panel in Philadelphia sided with cancer victims, who argued that J&J wrongly put its specially created unit, LTL Management, under court protection to block juries around the country from hearing the lawsuits.”

Pharma wins a key round in a court battle with hospitals over a drug discount program “In a victory for the pharmaceutical industry, a federal appeals court ruled drug companies have the right to limit discounts to hospitals that rely on numerous contract pharmacies as they participate in a U.S. government drug discount program.
The decision was made in response to lawsuits that were originally filed by three large drugmakers — Sanofi, Novo Nordisk, and AstraZeneca — that the federal government was unlawfully interpreting key provisions in the controversial 340B drug discount program. The matter is actually not resolved, though, because the same dispute is still being considered in two other appeals courts.”

 Simulated Medicare Drug Price Negotiation Under the Inflation Reduction Act of 2022 “In this cross-sectional study using a policy simulation analysis, 40 top-selling drugs that would have been selected for negotiation from 2018 to 2020 were identified; although individual Medicare Part D plans already received substantial discounts for many of these drugs, the statutory ceiling prices for negotiation would have reduced spending by $26.5 billion on these drugs, or 5% of estimated net Medicare drug spending, from 2018 to 2020.”

10 top M&A targets in biotech for 2023 FYI

The top 10 biopharma M&A deals of 2022 FYI

Pharma reputation scores drop to pre-COVID levels as Haleon tops most respected, but it's a huge fall from grace for Pfizer and Moderna “Although trust in pharma spiked during the pandemic, it seems companies' reputations are back to pre-COVID-19 levels—and there’s bad news for the biggest COVID vaccine makers.
That’s according to a new report out by Caliber, which found that in 2022 only four out of 10 people were likely to say something positive about a pharma company…
Before the COVID-19 pandemic, about 32% of the U.S. public had a positive opinion of the pharmaceutical industry, Rob Jekielek, managing director of Harris Poll, said in an interview with Fierce Pharma in late 2021.
That number jumped to 59% of patients rating pharma’s reputation as “excellent” or “good” in the same year. In 2023, it seems the industry is coming down from its peak, and consumers are looking for new ways to affirm their trust.”

CVS, Walmart to Cut Pharmacy Hours as Staffing Squeeze Continues “CVS Health Corp. and Walmart Inc. are cutting pharmacy hours in the midst of a pharmacist shortage that has plagued the nation’s biggest drugstore chains throughout the Covid-19 pandemic.
CVS, the largest U.S. drugstore chain by revenue, plans in March to cut or shift hours at about two-thirds of its roughly 9,000 U.S. locations. Walmart plans to reduce pharmacy hours by closing at 7 p.m. instead of 9 p.m. at most of its roughly 4,600 stores by March.
Walgreens Boots Alliance Inc. previously said it was operating thousands of stores on reduced hours because of staffing shortages. Combined, the three chains operate some 24,000 retail pharmacies across the U.S.”

About healthcare IT

The Potential Impact of Artificial Intelligence on Healthcare Spending “In this paper, we estimate that wider adoption of AI could lead to savings of 5 to 10 percent in US healthcare spending—roughly $200 billion to $360 billion annually in 2019 dollars. These estimates are based on specific AI-enabled use cases that employ today’s technologies, are attainable within the next five years, and would not sacrifice quality or access. These opportunities could also lead to non-financial benefits such as improved healthcare quality, increased access, better patient experience, and greater clinician satisfaction. We further present case studies and discuss how to overcome the challenges to AI deployments. We conclude with a review of recent market trends that may shift the AI adoption trajectory toward a more rapid pace.” 

Today's News and Commentary

About Covid-19

 FDA advisers favor retiring original covid shot and using newer version “Advisers to the Food and Drug Administration on Thursday unanimously endorsed retiring the original coronavirus shot in favor of one that targets both the original strain of the coronavirus and the omicron variant.” 

California law aiming to curb COVID misinformation blocked by judge “A U.S. judge has blocked a California law that sought to penalize doctors who spread ‘misinformation or disinformation’ about COVID-19 while he considers a pair lawsuits challenging it on free speech grounds.
Senior U.S. District Judge William Shubb in Sacramento ruled on Wednesday that Assembly Bill 2098, which was signed last October by California Governor Gavin Newsom, a Democrat, was too vague for doctors to know what kind of statements might put them at risk of being penalized.’COVID-19 is a quickly evolving area of science that in many aspects eludes consensus,’ he wrote.”

About health insurance/insurers

 States jump into fight over prior authorization requirements “Efforts to overhaul the prior authorization process are hitting a crescendo in state legislatures, with at least 40 states expected to consider measures that would streamline the way doctors must obtain health plan sign-offs before they can order procedures, tests or treatments.”

CMS OKs California Medicaid experiment for inmates “The Centers for Medicare & Medicaid Services (CMS) is approving California’s…request to amend the section 1115(a) demonstration titled, ‘California Advancing and Innovating Medi-Cal (CalAIM)’… to provide limited coverage for certain services furnished to certain incarcerated individuals for up to 90 days immediately prior to the beneficiary’s expected date of release… CMS is also approving federal matching funds for Designated State Health Programs (DSHP) that California will use, going forward, to partially support the Providing Access and Transforming Health (PATH) program that was approved as part of CalAIM on December 29, 2021.”

About hospitals and healthcare systems

 Minnesota attorney general asks Sanford Health, Fairview Health Services to delay 58-hospital merger “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening.
The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”

HCA posts $5.6B profit for 2022 “Nashville, Tenn.-based HCA Healthcare saw revenue of $15.5 billion in the fourth quarter of 2022, up from $15.1 billion over the same period in 2021, according to its financial report released Jan. 27. 
The 182-hospital, for-profit system had a net income of $2.08 billion in the quarter ended Dec. 31, 2022, up from $1.81 billion over the same period last year.”

About the public’s health

 FDA eases blood donation ban on gay and bisexual men after years of protest “Gay and bisexual men in monogamous relationships will no longer be forced to abstain from sex to donate blood under federal guidelines announced Friday, ending a vestige of the earliest days of the AIDS crisis.
The proposed relaxation of restrictions by the Food and Drug Administration follows years of pressure by blood banks, the American Medical Association and LGBT rights organizations to abandon rules some experts say are outdated, homophobic and ineffective at keeping the nation’s blood supply safe.”

Gesundheit! Allergies Affect More Than One in Four "The rate of 27.2% among children 17 years and under represented an increase from previous decades, reported Benjamin Zablotsky, PhD, of the NCHS in Hyattsville, Maryland, and coauthors in NCHS Data Brief.
Among adults, 31.8% reported experiencing at least one allergic condition in 2021, Amanda E. Ng, MPH, and Peter Boersma, MPH, of the NCHS, reported in the same publication.
Seasonal and food allergies were more prevalent in adults than children in the U.S.”
[Note: This article from MEDPAGE TODAY is much more readable than the original. More data are in this article.]

It’s easy to buy flavored vapes in California, even in cities with longtime bans “California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers.
STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years. Seventeen of the shops, or 70%, were selling the products anyway. One city is doing much better than the others: In Oxnard, where we hit five shops, none of the stores sold flavored vapes.
Many of the sellers of these products appeared to be openly flouting the law with impunity.”

About healthcare IT

Interoperability and Methods of Exchange among Hospitals in 2021 Study from healthIT.gov:
"HIGHLIGHTS
—In 2021, more than 6 in 10 hospitals engaged in key aspects of electronically sharing health information (send, receive, query) and integrating of summary of care records into EHRs, a 51 percent increase since 2017.
—Availability and usage of electronic health information received from outside sources at the point of care significantly increased over the last four years, reaching 62 and 71 percent, respectively, in 2021.
—Health Information Service Providers (HISPs) and HIEs were the most common methods used for electronic exchange among hospitals.
—About three-quarters of hospitals participate in health information exchange organizations (HIEs) and about 35 percent participate in both HIEs and national networks.
—In 2021, 39 percent of hospitals reported participating in more than one of four measured national networks.
—Nearly 90 percent of hospitals upgraded their EHRs to 2015 Edition through 2021 and 74 percent of hospitals adopted bulk data export technology.”

Attorney General Merrick B. Garland Delivers Remarks on the Disruption of Hive Ransomware Variant “We are here to announce that last night, the Justice Department dismantled an international ransomware network responsible for extorting and attempting to extort hundreds of millions of dollars from victims in the United States and around the world.
Known as the ‘Hive’ ransomware group, this network targeted more than 1,500 victims around the world since June of 2021…
In one instance in August 2021, Hive affiliates deployed ransomware on computers owned by a Midwest hospital. At a time when COVID-19 was surging in communities around the world, the Hive ransomware attack prevented this hospital from accepting any new patients. The hospital was also forced to rely on paper copies of patient information. It was only able to recover its data after it paid a ransom…”

Today's News and Commentary

About Covid-19

Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Preventing Symptomatic SARS-CoV-2 Infection Attributable to Omicron BA.5– and XBB/XBB.1.5… “Using spike (S)-gene target presence as a proxy for BA.2 sublineages, including XBB and XBB.1.5, during December 2022–January 2023, the results showed that a bivalent mRNA booster dose provided additional protection against symptomatic XBB/XBB.1.5 infection for at least the first 3 months after vaccination in persons who had previously received 2–4 monovalent vaccine doses.”

About health insurance/insurers

Biden-Harris Administration Announces Record-Breaking 16.3 Million People Signed Up for Health Care Coverage in ACA Marketplaces During 2022-2023 Open Enrollment Season “…the Biden-Harris Administration announced that a record-breaking more than 16.3 million people have selected an Affordable Care Act (ACA) Marketplace health plan nationwide during the 2023 Marketplace Open Enrollment Period (OEP) that ran from November 1, 2022-January 15, 2023 for most Marketplaces.”

About pharma

Meet the 3 PBMs partnered with Mark Cuban's pharmacy “After Mark Cuban Cost Plus Drug Co. rerouted plans and partnered with a pharmacy benefit manager in September, the 1-year-old online pharmacy has grabbed two similar deals. 
The company chose Rightway, EmsanaRx and RxPreferred Benefits because ‘they pass through our pricing as is,’ Mr. Cuban told Becker's. On the company's site, Cost Plus calls itself ‘unPBM’ because there are ‘no rebates or off-shore entities to be found here.’”

Walgreens Weighs $2 Billion Sale of Pharmacy Automation Unit iA “Walgreens Boots Alliance Inc. is weighing a sale of its pharmacy automation business, which could fetch up to $2 billion, according to people familiar with the matter. 
The company, which is working with an adviser, is preparing to start a sales process in the next month or so for iA, said the people, who asked to not be identified because the matter is private. The unit is expected to draw interest from rival health-care companies and private equity firms, the people said. No final decision has been made and Walgreens could opt to keep the business, they added.”

 After nearly 4 years of deliberation, FDA punts on how to regulate CBD “The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too.”

Orphan Drug Exclusivity Regulations Will Remain As Is, Says FDA “The FDA said it will keep in place its regulations on orphan drug exclusivity rather than altering them in response to a pivotal U.S. appeals court ruling.
The agency said it plans to continue to tie orphan drug exclusivity to the uses or indications for which the orphan drug was approved rather than considering allowing for more expansive marketing rights.”

About the public’s health

 Predictive Accuracy of Stroke Risk Prediction Models Across Black and White Race, Sex, and Age Groups “Findings  In this retrospective study of predictive accuracy that included 62 482 participants, existing stroke-specific risk prediction models and novel machine learning techniques did not significantly improve discriminative accuracy for new-onset stroke compared with the pooled cohort equations. All algorithms exhibited worse discrimination in Black individuals than in White individuals. Calibration was most accurate using the Reasons for Geographical and Racial Differences in Stroke (REGARDS) model based on self-reported risk factors.
Meaning  Results indicate the need to expand the pool of risk factors and improve modeling techniques to address observed racial disparities and improve model performance for predicting new-onset stroke.”

Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association Summaries of all chapters at the beginning of the paper are a helpful guide to this extensive report.

About healthcare personnel

 'Operation Nightingale': Feds charge 25 in sweeping nurse diploma scheme “Twenty-five people have been charged for their alleged participation in a coordinated scheme to sell aspiring nurses thousands of fake nursing degree documents, the Justice Department said Jan. 25.
The scheme involved selling more than 7,600 fraudulent diplomas and transcripts from three now shuttered nursing schools in Florida to aspiring nurses who had not actually completed the necessary coursework to graduate or sit for the National Council Licensure Examination. Aspiring nurses would allegedly pay $10,000 or more for the fake diplomas, which fast-tracked the process for them to take the NCLEX test and gain licensure. Once licensed, applicants allegedly used the fake documents to secure employment ‘with unwitting healthcare providers throughout the country,’ officials said.”

Institutional Variability in Representation of Women and Racial and Ethnic Minority Groups Among Medical School Faculty “Findings  In this cross-sectional study of faculty from 144 US medical schools from 1990 to 2019, the median representation quotient for women increased from 0.42 to 0.80. The median representation quotient for URM increased from 0.16 to 0.24, but the trend was not significant, and variability across institutions was high.
Meaning  These findings suggest that representation of women in academic medicine increased over time, whereas URM experienced only modest increases in representeation with wide variability across institutions.”

About health technology

 The Power 500 Healthcare Technology Companies of 2023 FYI (Categories include IT)

Today's News and Commentary

About health insurance/insurers

AFFORDABILITY SOLUTIONS FOR THE HEALTH OF AMERICA A statement and recommendation from the BCBS Association. It claims their recommendations will save $767B over ten years. One recommendation is to enact single site payments.

Elevance Health posts $949M profit in fourth quarter “Elevance Health reported double-digit revenue growth and beat investor expectations in 2022, but posted a slight dip in profits year-over-year, according to the company's fourth quarter earnings report published Jan. 25.”

Health Insurers Face $3 Billion Medicare Clawback Threat A really good summary of the impact of upcoming Medicare audits to assess overpayments due to excessive severity of illness extra payments.

6.8 million expected to lose Medicaid when paperwork hurdles return “The federal Department of Health and Human Services expects 6.8 million people to lose their coverage even though they are still eligible, based on historical trends looking at paperwork and other administrative hurdles. Pre-pandemic, some states made signing up for and re-enrolling in Medicaid very difficult to keep people off the rolls.
In the three pandemic years, the number of Americans on Medicaid and CHIP – the Children's Health Insurance Program – swelled to 90.9 million, an increase of almost 20 million.”

About pharma

 CVS Health debuts new virtual primary care “CVS Health launched new virtual care offerings Jan. 23 focused on primary care and mental health services.
CVS Health Virtual Primary Care includes pre-scheduled primary care and mental health visits as well as on-demand services. All Aetna commercial members in fully-insured and self-insured health plans can use the virtual care platform.”

Kroger to launch its 1st personalized medicine trial “Kroger Health, the national grocery chain's healthcare division, will set up clinical trial sites for research on colorectal cancer gut and immune health with the aim of developing personalized medicines. 
It will be the company's first clinical trial…”
Healthcare gets stranger and stranger…

Pharma's 15 biggest lobbyists FYI

J&J Gets Ready to Break Up With Tylenol “Johnson & Johnson confirmed during an earnings call on Tuesday that its consumer health business is on track to become independent this year. Earlier this month, J&J filed for an initial public offering of the unit as a separate company called Kenvue.
The idea of the separation is that, by spinning out its slower-growing consumer unit, J&J will be able to focus on its higher growth divisions: med-tech and pharma. 
But in the most recent quarter, it was the consumer unit that delivered growth, while pharma and med-tech were laggards. The main reason for that was the heightened demand for over-the-counter products like Tylenol and Motrin.”
See, also: J&J's profit forecast tops estimates, with key drugs, new launches to drive growth

About the public’s health

 USPSTF Declines to Recommend Lipid Tests for All Kids “Citing a lack of available data, the US Preventive Services Task Force (USPSTF) announced Tuesday that it is unable to make a recommendation on whether clinicians should screen children and adolescents for lipid disorders.” 

With the X-Waiver repealed, officials urge providers to begin prescribing buprenorphine for opioid addiction “The White House, federal agencies and lawmakers today marked the elimination of the DATA-Waiver Program, better known as the X-Waiver requirement, with calls for providers to begin incorporating opioid use disorder treatment buprenorphine in everyday patient care.
The X-Waiver requirement only permitted doctors who had received specialized training and federal permissions to prescribe the opioid partial agonist, which is a controlled substance.”

How Gen Z sees healthcare: 10 stats FYI

Medical Costs of Substance Use Disorders in the US Employer-Sponsored Insurance Population “Findings  In this economic evaluation of 162 million non–Medicare eligible enrollees with employer-sponsored health insurance in 2018, 2.3 million had an SUD diagnosis. The annual attributable medical expenditure was $15 640 per affected enrollee and $35.3 billion in the population; alcohol-related disorders ($10.2 billion) and opioid-related disorders ($7.3 billion) were the most costly.”

About healthcare IT

 Payers spent about the same for telehealth or in-person visits in 2020 “Prices were broadly similar for in-person and virtual services. The average cost for established patient evaluations was $33 dollars for in-person care and $34 dollars for telehealth.” 

FCC Allows Use of Automated Calls, Texts for Coverage, Enrollment Info “The Federal Communications Commission (FCC) has issued guidance allowing federal and state governmental agencies to send automated calls and text messages providing individuals with information about retaining their enrollment in government healthcare programs.
The declaratory ruling responds to a letter from US Department of Health and Human Services (HHS) Secretary Xavier Becerra, in which the department asked for clarification about which types of calls and text messages were permissible under the Telephone Consumer Protection Act (TCPA).”

About healthcare personnel

 Major medical schools join widening revolt against U.S. News rankings “Criticism of ranking system grows as schools based at Stanford, Columbia, U-Penn and Mount Sinai pull out.” 

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.’