Today's News and Commentary

HHS further delays rule that could void thousands of regulations: “HHS will further delay the start date on a rule that would require the department to eliminate existing regulations after 10 years unless the department reviewed them and could justify keeping the regulation in place, according to an March 3 Federal Register notice.
The Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET rule, was finalized by HHS a day before President Joe Biden's inauguration. The policy was slated to take effect in March 2021, but HHS postponed the final rule until March of this year.
Now, the rule will be delayed by another six months to Sept. 22, pending judicial review, HHS said.”

About Covid-19

 More than 90% of U.S. population in areas where masks not needed -CDC: "The U.S. Centers for Disease Control and Prevention (CDC) on Thursday said some 93% of the U.S. population live in locations where COVID-19 levels are low enough that people do not need to wear masks indoors…
When it announced the revised guidelines, the CDC said about 70% of U.S. counties and 72% of the U.S. population were in communities where indoor face coverings are no longer recommended. The CDC plans to update its county ratings weekly.
The agency said on Thursday that 85.4% of counties now rank as low or medium risk and 92.9% of the population lives in those counties.”

Health care workers don unnecessary protective gear. The CDC and WHO need to update their PPE guidance: “Having taken care of hundreds of Covid-19 patients, we would have no concern about entering a patient’s room without an isolation gown, because this infection is transmitted through the air via droplets and aerosols, not by touching a contaminated surface. Although hand washing is always an important part of infection prevention efforts, contamination of one’s clothes, hair and shoes have never been shown to be a problem.
It makes no sense for health care workers to gown up to go into the rooms of Covid-19 patients they often have fleeting contact with.
The CDC also needs to dial back on its messaging that cleaning surfaces and using hand sanitizer will decrease the risk of Covid transmission, when there is no evidence to support either.”
The authors stress that the needless PPE use also adds to a problem of medical waste.

About health insurance

 CMS URGES STATES TO TAKE IT SLOWIn a Thursday letter, Center for Medicaid and CHIP Services Director Daniel Tsai cautioned states not to rush through the process of determining whether Medicaid enrollees are still eligible for their health coverage when the pandemic ends. Many state officials and Medicaid advocates have long worried about what will happen when the redetermination process resumes…
Some highlights:
A new timeline: Federal health officials had planned to give states 12 months to complete their work. Now, they’re being given 14 months — 12 months to start the renewals and an extra two months to wrap up.
A request for data: States would be required to submit data monthly over 14-months to demonstrate their progress toward completing the redetermination process.
A word of caution: Federal health officials warn states that, if they don’t stick to CMS’ timeline and try to rush through the redetermination process, they might face corrective action.”

Seeking to Shift Costs to Medicare, More Employers Move Retirees to Advantage Plans: “Over the past decade, an increasing number of employers have taken a similar deal, using the government’s Medicare Advantage program as an alternative to their existing retiree health plan and traditional Medicare coverage. Employers and insurers negotiate behind closed doors to design a private Medicare Advantage plan available only to retirees from that employer. Then, just as it does for private individuals choosing a Medicare Advantage plan, the federal government pays the insurer a set amount for each person in the plan.
Experts say this arrangement often saves the employer money because the federal payment reduces the employer’s share of the cost of coverage…
The number of beneficiaries in employer-sponsored Medicare Advantage plans has soared from about 1.6 million in 2008 to more than 5 million last year, according to CMS…”

About hospitals and healthcare systems

 Court Tosses Medicare Reimbursement Boost for Low-Wage Hospitals: “Congressionally required adjustments in Medicare reimbursements designed to account for regional differences in labor costs cannot be further adjusted to give an extra boost to low-wage hospitals, a federal district judge ruled.
The lawsuit was filed by a group of hospitals challenging a 2019 regulation issued to address wages disparities among hospitals. The hospitals claimed they would receive reduced reimbursements as a result of the regulation.”

About pharma

 Robotic pill can orally deliver large doses of biologic drugs: Biologics cannot be given orally because they are digested before the active ingredients are absorbed. “Now, NIBIB [National Institute of Biomedical Imaging and Bioengineering]-funded researchers are developing a robotic pill that, after swallowing, can deliver biologic drugs into the stomach, which could potentially revolutionize the way that certain conditions are treated…
Once the pill has been swallowed and makes its way into the stomach, it uses its weighted bottom to orient itself properly, so that its injection mechanism is flush against the stomach wall. After a few minutes, a carbohydrate pellet at the top of the pill dissolves, activating a spring and enabling a needle to inject the biologic drug into the stomach tissue. Then, a second, newly exposed pellet dissolves, freeing the spring and retracting the needle back inside the pill, allowing for safe passage of the device through the gastrointestinal tract…
In their study, reported in Nature Biotechnology, the authors loaded their robotic pills with one of four biologic drugs—insulin; a glucagon-like peptide 1 (GLP-1) analog (also used for the management of diabetes); adalimumab (brand name Humira®, an immunosuppressive drug used for a variety of conditions, including arthritis and Crohn's disease); or epinephrine (for the emergency treatment of allergic reactions or asthma attacks).”

About the public’s health

 Study finds drinking wine with meals was associated with lower risk of type 2 diabetes:
Research Highlights:

  • A study including nearly 312,000 current drinkers suggests consuming moderate amounts of alcohol (no more than 14 grams per day for women and 28 grams per day for men), especially wine, with meals was associated with a lower risk of developing type 2 diabetes.

  • Lower type 2 diabetes risk occurred only when people drank alcohol with meals, not when alcohol was consumed alone.

  • Only moderate amounts of alcohol had a positive impact on the development of type 2 diabetes – up to one glass of wine daily for women and up to two glasses daily for men.

  • The American Heart Association recommends that adults who do not drink alcohol should not start. Among adults who drink alcohol regularly, they should talk with their doctors about the benefits and risks of consuming alcohol in moderation. Experts caution these results are not a reason for nondrinkers to start consuming alcohol.”

The Association Between E-Cigarette Use and Prediabetes: Results From the Behavioral Risk Factor Surveillance System, 2016–2018: “We defined sole E-cigarette users as current E-cigarette users who are never combustible-cigarette users, and dual users were defined as both current E-cigarette and combustible-cigarette users…
In this representative sample of U.S. adults, E-cigarette use was associated with greater odds of prediabetes. The results were consistent in sole E-cigarette users.”

About healthcare IT

 Microsoft closes on $16 billion acquisition of Nuance : “The deal, which was announced last year, helps Microsoft Corp. get more entrenched into hospitals and the health care industry through Nuance’s widely used medical dictation and transcription tools. The acquisition is Microsoft’s second-largest after its $26 billion purchase of career networking service LinkedIn in 2016.”

Health information exchanges boost physician referrals 46%: study: “A study from the New York-based University at Buffalo School of Management analyzed datasets from 22,000 Medicare beneficiaries in Western New York from 2009 to 2012 to examine the impact of health information exchanges on patient referral. 
Researchers found that physicians who joined an exchange experienced a 44 percent to 46 percent increase in the rate of referrals to and from other members.” 

Today's News and Commentary

About Covid-19

 Call for Stories and Research on Health Misinformation: “U.S. Surgeon General Dr. Vivek Murthy is calling for research, data, and personal experiences related to health misinformation, in an effort to deepen our collective understanding of its sources and impact.”

Effectiveness of Ad26.COV2.S [J&J] Vaccine vs BNT162b2 [Pfizer/BioNTech] Vaccine for COVID-19 Hospitalizations: “This study found that the Ad26.COV2.S vaccine is less effective against COVID-19–related hospitalization than the BNT162b2 vaccine. These results strengthen the evidence supporting a second dose in people who received the Ad26.COV2.S vaccine by an mRNA vaccine as recommended in both France and the US.”

In Symbolic Vote, Senate Rejects Vaccine Mandate for Health Workers: “In a vote forced by Republicans, the measure passed 49 to 44 along party lines, after six Democratic absences left the majority party short of the votes needed to defeat it. The measure is all but certain to die in the Democratic-controlled House; even if it cleared that chamber, the White House said on Wednesday that Mr. Biden would veto it.”

Hundreds of COVID trials could provide a deluge of new drugs: A great summary of what has been approved and what is in the pipeline.

 Prioritizing Case Investigation and Contact Tracing for COVID-19: Some highlights of a new policy this week from the CDC:

—”Universal case investigation and contact tracing are not recommended for COVID-19.
—Health department jurisdictions should prioritize specific settings and groups at increased risk.
—Case investigation and contact tracing are separate processes with distinct benefits and goals; decisions to initiate either should be made separately.
—Investigations should focus on COVID-19 cases and close contacts with onsets and exposures in the previous 5 days for those settings and groups at increased risk.”

U.S. to share some coronavirus technologies with World Health Organization: “Under the plan, some technologies now being developed by the National Institutes of Health will be licensed to the WHO’s COVID-19 Technology Access Pool, senior NIH official Anthony S. Fauci told reporters. The technologies will also be sub-licensed to the United Nations-backed Medicines Patent Pool.
Fauci declined to detail which technologies would be made available for licensing by other countries, saying the plan’s details were ‘still being ironed out.’”

About health insurance

Suburban Chicago Businessman Admits Swindling Hospital in Connection With Attempted Purchases of Personal Protective Equipment: “Haggerty and two business partners in March 2020 formed a company called At Diagnostics Inc. to sell personal protective equipment. The company reached an agreement with a hospital in Iowa to sell 500,000 N95 respirator masks for $2.495 million. Haggerty created an invoice to reflect the agreement and to instruct the hospital on where to wire the payment. Based on the invoice, the hospital on March 31, 2020, wired the money to a bank account that Haggerty falsely claimed was an At Diagnostics account but which was actually the account of a different business solely controlled by Haggerty.
 Haggerty admitted in a plea agreement that he spent part of the money for his own personal benefit, including purchasing two Maserati automobiles and a Land Rover sport-utility vehicle, paying nearly $189,000 to credit card companies, withdrawing more than $147,000 in cash, and paying $20,000 to a personal friend. Haggerty further admitted that At Diagnostics never delivered the masks, and when questioned about it by the hospital he falsely claimed that the bank had no record of the hospital’s payment being received.”

Memorandum Regarding Continuing Surprise Billing Protections for Consumers: From the US Department of Labor Department of Labor:
”On February 23, 2022, the United States District Court for the Eastern District of Texas, in the case of Texas Medical Ass'n, et al. v. United States Department of Health and Human Services, et al., Case No. 6:21-cv-425 (E.D. Tex.), invalidated portions of an interim final rule, Requirements Related to Surprise Billing; Part II, 86 Fed. Reg. 55,980 (Oct. 7, 2021) (the "Rule"), issued by the Departments of Health and Human Services, Labor, and the Treasury (the "Departments") governing aspects of the federal independent dispute resolution (IDR) process under the No Surprises Act.
This court's order did not affect any of the Departments' other rulemaking under the No Surprises Act. Thus, consumers continue to be protected from surprise bills for out-of-network emergency services, out-of-network air ambulance services, and certain out-of-network services received at in-network facilities. The patient-provider dispute resolution process for uninsured and self-pay consumers to dispute bills that exceed a provider's or facility's good faith estimate by $400 or more also remains available and unchanged by the court's order. To learn more about these protections, visit www.cms.gov/nosurprises.”

Bright Health Group Reports Fourth Quarter and Full Year 2021 Results: “Bright Health Group, Inc., a diversified healthcare services company building a technology-enabled, fully-aligned, national Integrated System of Care personalized for consumers, reported [yesterday] financial results for its fourth quarter and full year ended December 31, 2021.” As usual for these type of reports, the article leads with a rosy forecast from the CEO: "Bright Health Group achieved substantial growth in 2021, delivering $4 billion in Revenue, and reaching a significant scale milestone of serving over 1 million health plan lives for the start of 2022.”
However, the Medical Expense and Operating Cost Ratios are at their historic highest, with adjusted EBITDA loss of $1,080.9 million and GAAP Net Loss of $1,178.4 million.

About hospitals and healthcare systems

DO HIGHER-PRICED HOSPITALS DELIVER HIGHER-QUALITY CARE?: “Being admitted to a hospital with two standard deviations higher prices raises spending by 52% and lowers mortality by 1 percentage point (35%). However, the relationship between higher prices and lower mortality is only present at hospitals in less concentrated markets. Receiving care from an expensive hospital in a concentrated market increases spending but has no detectable effect on mortality.”

 CMS wallops nursing homes with planned staffing requirements and increased penalties: “The Centers for Medicare & Medicaid Services will establish minimum staffing requirements as part of a broad plan to “crack down on unsafe nursing homes,” the White House announced on Monday. 
The agency said it plans to conduct a new study to determine the level and type of staffing needed to ensure safe and quality care and will issue proposed rules within one year.”

About pharma

 Civica to manufacture, distribute insulin at discounted price: “Civica, a nonprofit generic pharmaceutical company, plans to manufacture and distribute three insulins to make them available to people with diabetes at significantly lower prices than those currently on the market. 
The company will produce glargine, lispro and aspart, the generic versions of Lantus, Humalog and Novolog, respectively, and plans to recommend consumer prices be capped at $30 per vial and $55 for a box of five pen cartridges, according to a March 3 news release.
Civica will co-develop the drugs with GeneSys Biologics, complete clinical trials and file FDA approval applications. The company expects glargine, the first insulin it plans to produce, will be available in early 2024, pending FDA approval.”

Sacklers agree to $6 billion Purdue bankruptcy settlement over opioid crisis: “The Sackler family members who own Purdue Pharma have agreed to pay up to $6 billion to settle a hotly contested bankruptcy plan, which will allow state governments and tens of thousands of people to be compensated for the company’s role in the opioid crisis.”

Pain Clinic Owners Convicted of Unlawfully Distributing Opioids and Multimillion-Dollar Health Care Fraud: “Mark Murphy, 65, and his wife, Jennifer Murphy, 65, both of Lewisburg, owned and operated North Alabama Pain Services (NAPS), which closed its Decatur and Madison offices in early 2017. Over the approximately five-year period leading up to the clinic closing its Alabama locations, Murphy and his wife, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others.”

About the public’s health

 Suicide Mortality in the United States, 2000–2020: “After increasing from 2000 through 2018, the age-adjusted suicide rate declined from 2018 (14.2 per 100,000) to 2020 (13.5).
Suicide rates for females in all age groups over age 25 showed recent declines, while rates for those aged 10–14 and 15–24 have generally increased.”
Firearms was the leading method.

About healthcare IT

 Allscripts to sell net assets of hospital business segment for $700M: “Allscripts is selling the net assets of its business segment for hospitals and large physician practices to N. Harris Computer Corp., a subsidiary of Constellation Software…
The business segment includes the following Allscripts products: Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, STAR, HealthQuest and dbMotion, according to a March 2 news release.” 

About health technology

Fitbit recalls 1 million Ionic watches after burn injuries: “Google-owned Fitbit has recalled 1 million of its Ionic smartwatches after dozens of users reported burn injuries after the battery overheated.”

Today's News and Commentary

Biden's State of the Union: 7 healthcare takeaways: An excellent summary of the headline’s topic.
Also, read: AHIP Comments on President Biden’s State of the Union Health Care Priorities

About Covid-19

Omicron subvariant doubling every week in US: “The subvariant accounted for an estimated 8.3 percent of COVID-19 cases in the week ending Feb. 26…
The U.S. has confirmed 2,796 COVID-19 cases involving BA.2 as of Feb. 28, according to outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups.
The subvariant has been found in every U.S. state and 86 countries worldwide.”

White House rolls out next COVID-19 plan: 8 details: “The debut of the 96-page plan coincides with falling COVID-19 cases in the U.S., which President Joe Biden mentioned during his State of the Union address to Congress on March 1.”

Declines in COVID concerns and mask mandate support: “Twenty-four percent are extremely or very worried about themselves or a family member being infected with COVID-19. This is down from 36% who felt the same in the past couple of months, when the omicron variant caused a spike in cases. Vaccinated adults are about twice as likely as unvaccinated Americans to be concerned about infection (28% vs. 13%)…
Half of Americans approve of mask mandates compared with 28% who oppose. Yet, support for this measure is down from 55% who supported the mask mandates in August 2021 and 75% in December 2020.
Americans vaccinated against COVID-19 are more likely to support mask mandates than the unvaccinated.  Even when controlling for vaccine status, Democrats are also more likely than Republicans and independents to say they support the policy.”

FDA doubles dosage of Covid-19 monoclonal antibody, raising concerns about access and supply: “‘Based on the most recent information and data available, Evusheld may be less active against certain Omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose,’ the FDA said in a news release.”

 Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5–17 Years — VISION Network, 10 States, April 2021–January 2022: “Two doses protect against COVID-19–associated emergency department and urgent care encounters among children and adolescents. However, vaccine effectiveness (VE) was lower during Omicron predominance and decreased with time since vaccination; a booster dose restored VE to 81% among adolescents aged 16–17 years. Overall, 2-dose VE against COVID-19–associated hospitalization was 73%–94%.” 

Hospital Worker Vaccination Rate Data Withheld Until October: “The Centers for Medicare & Medicaid Services has three months-worth of data on vaccination rates that it started requiring hospitals to submit Oct. 1, 2021. ‘CMS will not be updating this measure with quarterly refreshes until the agency has a full year of data in October 2022,’ a CMS spokesperson said in an email.
The agency said it takes time to collect the data, analyze it, and get it ready for public viewing. Advocates say the data, even if incomplete, could help patients make informed decisions about the risks associated with visiting a hospital.”


About health insurance

Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialty: This article and the accompanying editorial highlight the inaccuracy of using a time component to set RVUs for surgery.
”How do procedure times estimated using Medicare claims compare with the times used in the valuation process for determining Medicare payments for procedures?

Findings  In this cross-sectional study that analyzed 4.9 million procedures, the mean estimated procedure time was 27% lower than the time currently used in the valuation process. There was substantial variation across specialties in the difference between estimated and valuation procedure times.”
When 1 Plus 1 Equals 3—The Art, Not Science, of RVU Valuations: One highlight:
”…each work measure—operative time, length of stay, etc—is multiplied by an intensity factor to allow higher or lower rates of compensation per unit time. Intensity is the true black box of the RVU update process. These modifiers vary more than 40-fold from 1 procedure to the next with no relationship between intensity and any traditional measure of surgical complexity.7 There is little justification that any procedure should pay a physician more than 40 times more, per minute, than another.”

 Better Medicare Alliance: 99.9% of Medicare Advantage plans offering supplemental benefits: “A new study found that 99.9% of Medicare Advantage plans are offering supplemental benefits in 2022, with vision and hearing benefits the most widely offered…
The Centers for Medicare & Medicaid Services (CMS) expanded the number of benefits MA plans could offer to enrollees in 2018 and 2019.
The benefit most widely offered by MA plans was vision coverage, an option included in 97% of plans. This was shortly followed by hearing (94%), fitness (94%) and dental care at 91%.”

Feds Report $88B In Medical Debt On Credit Reports: “Medical debt is far and away the most common type of liability on credit reports. On Tuesday, Consumer Financial Protection Bureau officials questioned whether it belongs there at all. As of last year, 58% of all third-party debt collections were for medical debt, the agency determined in a new report. About 20% of U.S. households owe medical debt, which appears on 43 million credit reports, the CFPB found.”

About hospitals and healthcare systems

 Cleveland Clinic's operating income more than triples in 2021: “Cleveland Clinic posted an operating income of $746.3 million in 2021, more than triple the $232.4 million recorded in 2020, according to its recently released financial results.
The 19-hospital system also reported a 66.7 percent increase in net income for the 12 months ended Dec. 31, 2021, from $1.3 billion in 2020 to $2.2 billion in 2021.”

About pharma

Harvard, MIT Win Patent Dispute Over Gene-Editing Technology: “A federal patent board says the valuable rights to develop and market gene editing, the transfer of genetic technology between living organisms with the potential to cure diseases, belong not to UC Berkeley but to a research institute affiliated with Harvard and the Massachusetts Institute of Technology.
A researcher with the Broad Institute published a study in 2012 describing how the so-called CRISPR technology could be used to alter genes in humans, other animals and plants. The U.S. Patent and Trademark Office granted a patent to Broad in 2014, but it was challenged by the University of California, which contended the work was not original. Six months before Broad's study, a team of scientists led by UC Berkeley biochemist Jennifer Doudna had issued the first report on the use of CRISPR to alter DNA.
On Monday, however, the U.S. Patent Trial and Appeal Board said Broad's research had been original and its patent was valid. Although the Berkeley study was the first to uncover technology that could transform genetic material, the board said, it involved DNA in bacteria and had no direct application to genes in plants and animals, whose cells are classified as ‘eukaryotes.’”

Boots sale thrown off course by fewer buyers and market turmoil: “ Plans for a multi-billion-pound sale of UK chemist Boots have run into a series of difficulties after a potential buyer walked away and bidders raised concerns about financing a deal with markets in turmoil because of Russia’s invasion of Ukraine. Highlight text A consortium of Bain Capital and CVC Capital, previously seen as a leading candidate to buy the business from US parent Walgreens Boots Alliance, did not make a bid ahead of a deadline last week, two people with knowledge of the matter said.”

Nevada joins a little-known, ambitious state consortium dedicated to better drug prices: “After months of talks, the state of Nevada has joined a consortium formed by Oregon and Washington to pool purchasing power and get better prices on prescription drugs, the latest bid by a state government to try to blunt the rising cost of medicines.
The Northwest Prescription Drug Consortium, which began in 2006, claims to facilitate the purchase of more than $800 million in prescription drugs each year and saved at least 1 million people in Oregon and Washington nearly $100 million over the last six years.”

DIGITAL CONSUMER TRENDS IN PHARMA 2022: From Press Ganey. Some highlights:
”Nearly 1 in 2 [of surveyed persons] says finding the right doctor is a barrier to treatment
Almost 50% research prescriptions, medications, and medical devices on brand websites
~90% want physician directories available on life sciences and pharmaceutical sites
83% are more likely to use (or recommend) a brand website that has a doctor directory
Most consumers would prefer a digital appointment scheduling option”

 Federal Judge Rejects Eli Lilly’s Request That Whistleblower Suit Be Tossed Out : “This week, a federal judge in Chicago rejected Lilly’s attempt to dismiss the lawsuit, saying that the plaintiff, lawyer and pharmacist Ronald Streck, have presented evidence to the court suggesting that Lilly made false statements to the Centers for Medicare and Medicaid Services (CMS) regarding the amounts it charged distributors for its medicines between 2005 and 2016.”

About the public’s health

 Class-action lawsuits hit Abbott over contaminated baby formulas: “Several class-action lawsuits have been filed against Abbott Laboratories, claiming the company’s baby powder formulas—notably its Similac line— are making infants sick with bacterial infections, some so severe that several babies have been hospitalized and two have died…
 Salmonella newport and another type of bacteria called cronobacter sakazakii have been linked to baby powder formulas manufactured at Abbott’s Sturgis, Mich., plant.”

About healthcare IT

 Telemedicine destinations boost demand for medical office space: “More than 30% of telemedicine visits resulted in a physical office visit, according to a new survey by JLL…Notably, the survey did not indicate whether it was a new or returning patient, or what type of treatment the patients were looking for, the researchers say….
Despite this, the number of calls to specialists has increased the demand for medical offices, said Jay Johnson, managing director of JLL Healthcare. 
’Demand for medical office buildings is growing and supply has not kept pace. Rents for medical office buildings have peaked in the U.S. in the past couple of years,’ he said, adding that demand for medical office space rentals has been strong. before the pandemic. ‘The pandemic has not dampened this trend and has potentially reinforced it.’”

Allscripts Veradigm Ink Collaborates with the Social Security Administration: “Under the agreement, the agency will be able to request medical records electronically through the Veradigm network when processing disability claims. The health care providers in the company’s network will then receive electronic requests for medical records from the SSA with patient authorization, which can then be automatically released.”

About health technology

Magnets in newer portable electronic devices can interfere with implanted defibrillators: “Magnet technology is increasingly being used in portable electronic devices, such as the Apple AirPods Pro charging case, the Apple Pencil 2nd Generation and the Microsoft Surface Pen. However, if the devices are carried in pockets near the chest, and the individual has an implanted cardiac device (ICD), the magnets may interfere with the ICD’s ability to help regulate the heart, according to new research published today in Circulation: Arrhythmia and Electrophysiology, a peer-reviewed journal of the American Heart Association.”

 

 

Today's News and Commentary

About Covid-19

140 million Americans have had coronavirus, according to blood tests analyzed by CDC: “The estimates, compiled by the Centers for Disease Control and Prevention, show that about 43 percent of the country has been infected by the virus. The study shows that the majority of children have also been infected.”

 Most Americans say the coronavirus is not yet under control and support restrictions to try to manage it, Post-ABC poll finds: “The 34 percent overall who say they regard the pandemic as largely controlled is among the highest proportion since surveys began tracking such attitudes early in the pandemic. Yet nearly 6 in 10 U.S. adults think it is more important to control the virus, with some restrictions in daily life, while 4 in 10 prefer no restrictions.”
As expected (see the graphs), results are different between Democrats and Republicans. 

About health insurance

 Cigna stock buyback kicks off goal to generate $12B in value: “Cigna is looking to create $12 billion in value throughout 2022, starting with a plan to buy back $6 billion in stocks. 
The move was approved at Cigna's February board meeting, which brought the payer's total share repurchase authority to $10 billion. The company has already repurchased $1.2 billion in shares, with the intent to tap $7 billion this year on stock buybacks. 
The company highlighted that $5.4 billion of its deployable capital for the effort stems from its sale of international life, accident and supplemental benefits companies.”

Humana rolls out Kindred at Home's new brand, signals 'full integration': “Humana is rolling out Kindred at Home as CenterWell Home Health, an arm under its payer-agnostic brand, CenterWell.
Humana announced the creation of CenterWell in early 2021, a rebranded segment that houses all of its healthcare service offerings. Other subsidiaries have been rebranded to fit under this umbrella, with Kindred at Home being the latest move. 
The rollout as CenterWell Home Health signals Kindred's "full integration" into Humana, the payer announced March 1.”

Memorial Hermann, Blue Cross Blue Shield terminate contract, forcing estimated 100K patients out of network: “The state’s biggest insurer and the region’s biggest health system were unable to resolve their differences on the status of independent physicians affiliated with Memorial Hermann. Blue Cross Blue Shield wanted the doctors to contract directly with the insurer rather than through Memorial Hermann, which now negotiates rates for nearly 3,000 independent doctors in its system.” 

About pharma

Pharmaceutical Spending Up 77% Over 10 Years, Yet Out-of-Pocket Prescription Drug Costs Have Fallen in Same Period: Key findings

  • Spending on pharmaceutical products — prescription and nonprescription drugs — in the U.S. has skyrocketed since 2010. In 2020, pharmaceutical spending topped $570 billion — a 77% increase from $322 billion in 2010…

  • Despite these increases, out-of-pocket prescription drug costs are down compared to 2010 — even with some big jumps in the middle of the decade. Costs (including copays and coinsurance) dropped from $48 billion in 2010 to $47 billion in 2020, even with a spike to $52 billion in 2015.

  • Nationally, prescriptions cost $4,571 a year per household…

  • Only 5% of prescriptions are paid for entirely out of pocket across the U.S., but it varies widely by state. A staggering 12% of prescriptions in North Dakota are completely paid out of pocket, versus 3% or less in each New England state — Vermont, Massachusetts, Connecticut, Rhode Island, New Hampshire and Maine.”

FDA Clears Blood Cancer Treatment: “U.S. drug regulators ap- proved a new customized, cell- based treatment for blood cancer from Johnson & John- son that is the first such ther- apy in the U.S. to be developed initially in China.
The Food and Drug Administration on Monday cleared the therapy, named Carvykti, for the treatment of multiple myeloma in adult patients whose disease has worsened despite prior treatments with other drugs.
The approval suggests a possible path forward for Western drugmakers seeking to bring China-developed drugs to the U.S. amid con- cerns about the quality of the drugs’ development: conduct- ing separate, confirmatory studies in Americans.”

 Endo, Arnold & Porter Opioid Discovery Called 'Truly Awful': “Endo Pharmaceuticals and Arnold & Porter used a ‘coordinated strategy’ to hide key materials in opioid litigation, and the drugmaker deployed ‘disinformation’ and ‘intimidation’ after being severely punished for its discovery misconduct, a Tennessee judge wrote Monday. In a pair of rulings, Circuit Court Judge Jonathan Lee Young explained why he found Endo liable by default for discovery shortcomings in an opioid crisis case and rejected the company's argument that he has appeared biased and should disqualify himself from the matter.”

Viatris Agrees to Settle EpiPen Antitrust Litigation for $264M: “Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment…”
And in a possibly related story: Viatris Selling Its Biosimilars Business to Bangalore-Based Biocon for Up to $3.3B

HSA Singapore the First National Regulatory Authority Awarded the Highest Recognition for an Advanced Medicines Regulatory System by the World Health Organization: “The Health Sciences Authority (HSA) is the first National Regulatory Authority (NRA) and Singapore is the first World Health Organization (WHO) member state to achieve Maturity Level (ML) 4 for its advanced medicines regulatory system. This achievement came after a rigorous and comprehensive assessment by a team of 15 international assessors and 4 WHO officials using the WHO’s Global Benchmarking Tool
ML4 is the highest level of attainment for a regulatory system classification system conferred to an NRA that has met the highest quality standards stipulated by WHO for regulatory excellence. 

About the public’s health

 US births continue to decline but 'may be returning to pre-pandemic levels,' preliminary CDC data suggests: “US births dropped 2% in the first half of 2021 compared with the year prior, according to the new National Center for Health Statistics report, released Tuesday by the US Centers for Disease Control and Prevention. The same decline in births was observed for the first half of 2020, and births fell 5% in the second half of 2020…
NCHS researchers found that during the first half of 2021, compared with the same period in 2020, the nation's number of births declined 9% in January and 2% in February but then rose non-significantly by less than 1% in March and 1% in April, declined again by 1% in May and rose again by 3% in June.”

Senate Republicans, Manchin block bill to protect the right to abortion: “The Senate on Monday blocked consideration of a bill to protect the right to abortion nationwide, an election-year measure pushed by Democrats as the Supreme Court decides the fate of the landmark decision guaranteeing access to abortion.
Republicans and Sen. Joe Manchin III (D-W.Va.) voted against moving ahead on the legislation. The Senate fell 14 votes short of the 60 necessary to begin debate on a vote of 46-to-48.”

About healthcare IT

 Nearly 1M health records breached in February: “In February, 26 organizations reported to HHS that 941,680 individuals were affected by data breaches.” 

Information Blocking Claims: By the Numbers: “Total number of possible claims of information blocking complaints: 274” 176 were from patients; the next largest number, 42, was from attorneys.

Cigna plans to invest $450M in venture arm for digital health, analytics: “The company is eyeing targeted bolt-on or tuck-in acquisitions along with investments in earlier-stage companies through Cigna Ventures. The company's board authorized an additional $450 million to invest in its venture capital arm with a focus on contributing to early-stage companies in the areas of insights and analytics, digital health and experience and care delivery and enablement, according to an announcement.”

About healthcare personnel

 Health Care Expenditures Attributable to Primary Care Physician Overall and Burnout-Related Turnover: A Cross-sectional Analysis: “Turnover of PCPs results in approximately $979 million in excess health care expenditures for public and private payers annually, with $260 million attributable to PCP burnout-related turnover.”  

About healthcare finance

 Healthcare Trust of America, Healthcare Realty to combine in medical REIT deal: “The combined real estate investment trust will have 727 properties in its portfolio and a pro-forma total enterprise value of $17.6 billion as of Thursday's close.”

Today's News and Commentary

About Covid-19

Pfizer Shot Is Far Less Effective in 5- to 11-Year-Olds Than in Older Kids, New Data Show: “The vaccine’s effectiveness against hospitalization declined to 73 percent from 85 percent in the older children. In the younger children, effectiveness dropped to 48 percent from 100 percent. But because few children were hospitalized, these estimates have wide margins of error.
The numbers for protection from infection are more reliable. Vaccine effectiveness against infection in the older children decreased to 51 percent from 66 percent. But in the younger children, it dropped sharply to just 12 percent from 68 percent.”

Nearly half of Biden’s 500M free COVID tests still unclaimed: “Nearly half of the 500 million free COVID-19 tests the Biden administration recently made available to the public still have not been claimed as virus cases plummet and people feel less urgency to test.
Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.”

 Japanese study examines efficacy and side effects of mixed vaccines: “The average antibody level for people with triple Pfizer increased 54.1-fold and for those who received Moderna as their third dose, the average antibody level increased 67.9-fold.”
It remains to be seen whether this difference  is clinically significant.

Children with, without asthma maintain oxygen levels while masked during exercise: “Oxygen saturation did not significantly decrease among children who participated in low- or moderate-intensity exercise while masked, according to data presented at American Academy of Allergy, Asthma & Immunology Annual Meeting.
Also, researchers found no significant differences in peripheral oxygen saturation (SpO2) or dyspnea among those with and without asthma.”
So much for those who complain that masking children is bad for their physical health.

Health Canada Approves Plant-Based COVID-19 Vaccine: “Health Canada has approved Medicago’s Covifenz COVID-19 two-dose vaccine, the first authorized vaccine that uses plant-based proteins.
The vaccine, which is authorized for people aged 18 to 64 years old, was found to be 71 percent effective against symptomatic infection and 100 percent effective against severe disease in clinical trials. Each 3.75-mg dose is meant to be administered 21 days apart.”

Evusheld May Have Less Efficacy Against Omicron Subvariants: “AstraZeneca’s COVID-19 antibody Evusheld (tixagevimab/cilgavimab) may have limited efficacy against the Omicron subvariants, BA.1 and BA.1.1, the FDA said.
The agency also amended the therapy’s Emergency Use Authorization (EUA) to double the initial dosage to 300 mg of tixagevimab and 300 mg of cilgavimab, given the concerns over diminished efficacy.”

Moderna faces new lawsuit over lucrative coronavirus vaccine: “Arbutus and Genevant said in their lawsuit that Moderna infringed on their patent for so-called lipid nanoparticle technology, which they say was key in the development of Moderna’s mRNA vaccine and took scientists from Arbutus and Genevant ‘years of painstaking work to develop and refine.’ The suit had been expected after Moderna lost a U.S. Court of Appeals ruling last year in the protracted patent battle.”

Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians:

“Practice Point 1: Consider Remdesivir for 5 Days to Treat Hospitalized Patients With COVID-19 Who Do Not Require Invasive Ventilation or ECMO

Practice Point 2: Consider Extending the Use of Remdesivir to 10 Days to Treat Hospitalized Patients With COVID-19 Who Develop the Need for Invasive Ventilation or ECMO Within a 5-Day Course

Practice Point 3: Avoid Initiating Remdesivir to Treat Hospitalized Patients With COVID-19 Who Are Already on Invasive Ventilation or ECMO”

About health insurance

 UnitedHealthcare axes paper prior authorization, decision letters: UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website. 
The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made. 
According to the announcement, more UnitedHealthcare communications will make the shift to digital during 2022. The payer will issue warnings for each document moving to virtual distribution 90 days in advance.”

Lawyers say the California malpractice ruling will have minimal impact on insurance rates.: “Legal experts say the new ruling, which upholds California’s medical malpractice limit, will not materially impact providers’ insurance rates. 
On Thursday, the California Supreme Court upheld a lower court decision to cut $4.25 million in malpractice compensation for pain and suffering to the state’s $250,000 non-economic damages limit.”
Read the article for the particulars of the case. Many states have set or tried to set limits for non-economic damages for malpractice.

About hospitals and healthcare systems

 February 2022 National Hospital Flash Report: From KaufmanHall.
Margins
The sudden volume shifts and persistent expense increases pushed margins down in January. Not including federal CARES aid, the median change in Operating Margin dropped 71.3% from December to January. Year-over-year (YOY), the median change in Operating Margin was down 23.7% versus January 2021 and 73.3% compared to before the pandemic in January 2020, not including CARES.
The median change in Operating EBITDA Margin declined 52% month-over- month, 14.9% versus January 2021, and 52.7% versus January 2020. With CARES, the median change in Operating Margin declined 80.7% month-over-month and 23.8% YOY. The median change in Operating EBITDA Margin (with CARES) decreased 59.4% month-over-month and 19.6% YOY.

Volumes
The Omicron surge drove a drop in outpatient care as many providers and patients delayed nonurgent procedures in efforts to mitigate spread of the virus and ease traffic to hospitals experiencing an influx of COVID-19 cases. Operating Room Minutes were down 15.7% from December to January and 20.4% compared to before the pandemic in January 2020.
Hospitals saw an increase in more severe patients requiring longer hospital stays. Patient Days rose 1.7% month-over-month and 2.1% YOY. The Average Length of Stay (LOS) jumped 8.6% from December to January, and was up 4.9% compared to January 2021 and 17.2% versus January 2020.”

Mayo Clinic operating income jumps to $1.2B: Still, there are some “winners.”
“Rochester, Minn.-based Mayo Clinic's revenue totaled $15.7 billion last year, up from $13.8 billion in 2020. Net medical service revenue was up 7.7 percent year over year…
Mayo Clinic's operating expenses climbed 11.1 percent year over year to $14.5 billion in 2021. The health system saw expenses increase across several categories, including salaries and benefits. 
Mayo Clinic ended 2021 with an operating income of $1.2 billion, up from $728 million a year earlier.”

About pharma

  FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making: “ FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making…
These guidances are part of FDA’s PFDD efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I.”

About the public’s health

 New Report Recommends Changes to U.S. Organ Transplant System to Improve Fairness and Equity, Reduce Nonuse of Donated Organs, and Improve the System’s Overall Performance: Realizing the Promise of Equity in the Organ Transplantation System [ Note: Free pdf download] makes near- and long-term recommendations to create a fairer and more equitable, transparent, cost-effective, and efficient system for deceased donor organs. In addition to organ donors and patients, the key components of the transplantation system include donor hospitals, where the deceased donor is admitted; organ procurement organizations (OPOs), which procure organs after declaration of death; transplant centers, where the recipient is taken to surgery and gets the organ transplant; and the U.S. Department of Health and Human Services (HHS), which oversees the system’s performance. The report recommends actions that HHS should take to improve coordination across the different parts of the system, and ensure they have common goals and unified policies and processes.”

Children Living in Households That Experienced Food Insecurity: United States, 2019–2020: “In 2020, 10.8% of children aged 0–17 years lived in households that experienced food insecurity during the past 30 days.
The percentage of children who lived in food-insecure households was higher for non-Hispanic Black (18.8%) than Hispanic (15.7%) children, and higher for both non-Hispanic Black and Hispanic children than for non-Hispanic White children (6.5%).”

About healthcare IT

 STAT and MIT rooted out the weaknesses in health care algorithms. Here’s how we did it: “In July 2021, STAT and the Massachusetts Institute of Technology set out to answer a simple question with big implications for the use of AI in medicine: How do popular algorithms used to warn of bad outcomes for patients hold up over time?
The months-long experiment, born of a novel partnership in journalism and science, yielded an illuminating result: the algorithms deteriorated over several years, delivering faulty advice about which patients were at the highest risk of deadly complications and prolonged hospital stays.”

Digital Reshaping the Health-Care Ecosystem: From Bloomberg Intelligence: “Health-care delivery via telehealth will continue to accelerate after the industry's sea change in value with the pandemic. We believe the channel could reach $20 billion in revenue and represent 15% of outpatient visits by 2027 as barriers to adoption fall and new offerings such as virtual primary care take root. Incumbents like Teladoc and large managed-care companies will drive the next leg of growth….
At a minimum, we foresee the market expanding by 25% annually which essentially triples revenues to almost $17 billion in 2027.”

Teladoc set to launch on Amazon's Alexa: “Teladoc Health customers in the U.S. will be able to connect with a Teladoc care provider 24/7 from Echo devices for general medical needs. To get connected, patients can say “Alexa, I want to talk to a doctor” to their device. Echo will then connect with a Teladoc doctor for a virtual visit related to nonemergency needs, such as experiencing symptoms of a cold, flu or allergies, according to a Feb. 28 press release
The cost per visit will vary, ranging from $0 per visit with insurance or $75 without insurance.”

About healthcare personnel

 Association of Physician Management Companies and Private Equity Investment With Commercial Health Care Prices Paid to Anesthesia Practitioners:  “What is the association between outpatient facilities that contract with physician management companies (PMCs) and prices paid to anesthesia practitioners?
Findings  This cohort study of 2 255 933 privately insured patients who received anesthesia services in hospital outpatient departments and ambulatory surgery centers from 2012 to 2017 found that allowed amounts and unit prices increased by 16.5% and 18.7%, respectively, when facilities contracted with a PMC relative to non-PMC facilities. Larger increases were found if the PMC received private equity investment.”
PMCs consolidate practices, so they have better negotiating leverage. But the profit motive is still an important component of the higher negotiated fees.
The accompanying editorial is a good overview of PMCs: Physician Management Companies—Should We Care?

 

Today's News and Commentary

About Covid-19

CDC changes approach to covid: Most Americans can go without masks: “The Centers for Disease Control and Prevention eased mask recommendations for the vast majority of the country Friday under a new framework to monitor coronavirus that immediately affects about 70 percent of Americans — a process that state and local officials had already begun amid demands for a return to normalcy…
Under the new approach, many parts of the country that were previously considered to have high or substantial levels of the virus are now reclassified as having low to medium levels of covid-19 disease. CDC recommends mask-wearing for indoor public settings, including schools, only in communities with high levels of disease.”

How many people died believing vaccine misinformation?: “In a just-published nationwide survey of 18,782 people across all 50 states and the District of Columbia, the Covid States Project asked about four vaccine misinformation claims, asking respondents whether they were “true” or “false” or if a respondent was “not sure.” Five percent said they thought that vaccines contained microchips; 7 percent said vaccines used aborted fetal cells; 8 percent said the vaccines could alter human DNA; and 10 percent were concerned that vaccines could cause infertility. Forty-six percent were uncertain about the veracity of at least one of the four false statements…
Misinformation about vaccines has a direct correlation with whether people get immunized. The survey showed that among those who did not believe any of the false statements, 80 percent said they were already vaccinated. In the group that thought multiple false statements were true, 60 percent were hesitant to get the shot.”

 Moderna projects $19 billion in Spikevax sales this year: “During its earnings call on Thursday, Moderna said it generated $17.7 billion from its coronavirus vaccine Spikevax in 2021, through sales of 807 million doses worldwide. For this year, the company says it has signed $19 billion worth of orders for its vaccine, up from $18.5 billion announced in January. However, options for 2022 orders were revised downward to $3 billion, roughly $500 million less than what it had previously projected, amid fading pandemic concerns.”

EMA recommends authorisation of booster doses of Comirnaty from 12 years of age: “EMA's human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents1 (as well as adults and children from 5 years of age) and a booster dose is currently authorised from 18 years of age.
The CHMP opinion follows an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young recipients in Israel.”

Florida governor issues new COVID-19 guidance to 'buck CDC': “Florida Gov. Ron DeSantis and Florida Surgeon General Joseph Ladapo, MD, updated the state's COVID-19 guidance Feb. 24, which shortens isolation periods, advises against masks in community settings and grants healthcare practitioners flexibility to treat patients with emerging and off-label drugs for the virus.”

About health insurance

 Medicare Advantage plans gain record hold on the market in 2021, study says: “Medicare Advantage corporations added 2.3 million enrollees in 2021, with 1.3 million of these people switching from conventional, fee-for-service Medicare, in accordance with a report launched on Thursday by The Chartis Group. At least half of the eligible inhabitants in 11 states are actually enrolled in Medicare Advantage plans, up from three states final yr, the report stated…
Forty-five % of all beneficiaries—or 28 million people—are actually enrolled in Medicare Advantage plans.”

CMS overhauls Direct Contracting model to include new requirements on governance, health equity in 2023: “The Centers for Medicare and Medicaid Services announced Thursday that the professional and global Direct Contracting model will transition in 2023 to the Accountable Care Organization Realizing Equity, Access and Community Health (REACH) Model. In addition, the geographic Direct Contracting model on pause since March 2021 will be eliminated immediately.”
The changes are summarized here: CMS gives ACO model a makeover: 7 things to know: “The ACO REACH model has three main principles. The first is to improve health equity and bring the benefits of accountable care to underserved areas. CMS will do this through better support care delivery and will require model participants to create a health equity plan to be implemented in underserved communities.
The second principle is to promote provider leadership and governance, which will make sure doctors and healthcare providers play a vital role in accountable care, according to CMS. At least 75 percent of each ACO is to be controlled by participating providers and their designated representatives; the Global and Professional Direct Contracting model only required 25 percent. It also requires at least two beneficiary advocates on the governing board, with one being a Medicare beneficiary and one a consumer advocate.
The third principle is to protect beneficiaries and the model through more participant vetting, monitoring and transparency. More information on applicants' ownership, leadership and governing board will be required. There will be more up-ront screening of applicants, monitoring of participants and more transparency while the model is implemented. There will also be stricter protections against incorrect coding and risk score growth.”
The CMS Fact Sheet is here: Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model

Trends in Disenrollment and Reenrollment Within US Commercial Health Insurance Plans, 2006-2018: “In this longitudinal cohort study of 3 018 633 individuals, approximately 1 in 5 members disenrolled from a commercial insurer each year; however, among departing enrollees, approximately 1 in 3 returned to the insurer within 5 years.
Meaning  The findings of this study suggest that insurers can benefit from investing in members’ long-term health outcomes despite substantial short-term turnover rates.”

Other states keep watchful eye on snags in Washington’s pioneering public-option plan: “Washington state, in its second year of offering the nation’s first public-option health insurance plan, has learned an important lesson: If you want hospitals to participate, you’re probably going to have to force them.
The Washington public option is more of a public-private partnership: The plan was designed by the state but is offered by private insurance companies. Anyone buying their own policy on the state’s health insurance marketplace can sign up for a public-option plan and, depending on their income, may receive significant subsidies from the federal government to lower its cost. But two years in, the plans are available in only 25 of the state’s 39 counties, enrollment numbers have been underwhelming, and state leaders blame hospitals.”

UnitedHealth Unit Pays $5.8M To End Mass. Drug Price Probe: “A UnitedHealth Group subsidiary will pay $5.8 million to settle allegations that it overcharged Massachusetts employees for prescriptions under the state's workers' compensation program, the state's attorney general said Thursday.”

Physician pays over half million to settle allegations concerning ultrasound billing: “A 41-year-old primary care doctor has paid $504,588.40 to resolve allegations that he billed for excessive ultrasounds, announced U.S. Attorney Jennifer B. Lowery. 
Dr. Jose Escandon operates in Mission [Texas]. From Aug. 1, 2014, to Oct. 31, 2018, Escandon violated the False Claims Act by causing the submission of claims to Medicare for ultrasounds that were medically unnecessary or unreasonable. 
This investigation arose out of a proactive review of claims data showing Escandon was a significant statistical outlier for ultrasound claims.”

About hospitals and healthcare systems

Organ transplants reached their peak in 2021. Here are the busiest hospitals and common donor types: “During the start of the COVID-19 pandemic, organ transplants plummeted by half. Though there was an increase in deceased donors in 2020 from the year before, there were fewer living donors, possibly explained by the postponement of elective surgeries.
In 2021, however, the rate recovered and the U.S. reached a record number of transplants, at more than 41,300, though a significant waitlist for organs remains and may grow; experts expect there may grow a significant demand for kidney transplants in the years to come due to COVID…
California currently has the biggest waitlist for organs, with more than 20,500 candidates listed, of whom most (45%) are Hispanic. Texas has the second-biggest waitlist, with nearly 10,000 candidates, most of whom (43%) are also Hispanic. New York follows with the third-biggest waitlist, with more than 8,400 on the list, most of whom are white (34%) and Black (33%).”

About pharma

Judge Backs J&J Talc Bankruptcy, Keeping Cancer Lawsuits Frozen: “A bankruptcy judge allowed Johnson & Johnson to use chapter 11 to drive a settlement of litigation linking its baby powder to cancer, backing a controversial tactic that has helped profitable companies freeze roughly a quarter of a million injury lawsuits.
Judge Michael Kaplan of the U.S. Bankruptcy Court in Trenton, N.J., ruled Friday against personal-injury lawyers who asked to throw out the chapter 11 filing of a J&J subsidiary created last year to move into bankruptcy about 38,000 pending lawsuits over allegedly dangerous talc-based products.”

Johnson & Johnson, three pharma wholesalers finalize $26 billion opioid crisis settlement: “Johnson & Johnson and three major pharmaceutical wholesalers [AmerisourceBergen, Cardinal Health, and McKesson] have finalized nationwide settlements over their role in the opioid crisis, paving the way to distribute $26 billion to numerous state and local governments across the country.
The settlement is the largest so far among many lawsuits filed by communities seeking compensation for the decades-long expenses of coping with the fallout from addiction to opioid painkillers.”

 Lilly, Boehringer's Jardiance gets US nod for wider range of heart failure patients: “The FDA said Thursday that it has approved Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (HF) in adults, regardless of ejection fraction.” 

About the public’s health

 Understanding cervical cancer after the age of routine screening: Characteristics of cases, treatment, and survival in the United States: “Highlights:
Most women >65 years with cervical cancer were diagnosed at stage II or higher (63%), including 23% at Stage IV.
Nearly 15% of patients weren't treated, which was associated with age > 80, comorbidity scores ≥3, and stage IV disease.
5-year cancer-specific survival was 50% overall and treatment was associated with higher cancer-specific survival.
Increasing age and stage at diagnosis were associated with lower cancer-specific survival….
These findings, coupled with the fact that women >65 constitute an increasing proportion of the population, highlight the need to re-evaluate screening and treatment practices in this population to detect cervical cancer at earlier stages and increase survival.”

Strategies to Reduce Low-Value Cardiovascular Care: A Scientific Statement From the American Heart Association: An excellent review of the headline’s topic, but also a great overview of how to approach eliminating low-value care in general. While the entire article is worth reading, a quick read can focus on Tables 1 and 2.

Integrative Prioritization of Causal Genes for Coronary Artery Disease [CAD]: This study highlights the genetic complexity of CAD: “We identified 162 unique candidate causal CAD genes, which exerted their effect from between one and up to 7 disease-relevant tissues/cell types, including the arterial wall, blood, liver, skeletal muscle, adipose, foam cells, and macrophages. When their causal effect was ranked, the top candidate causal CAD genes were CDKN2B (associated with the 9p21.3 risk locus) and PHACTR1; both exerting their causal effect in the arterial wall. A majority of candidate causal genes were represented in cross-tissue gene regulatory co-expression networks that are involved with CAD, with 22/162 being key drivers in those networks.”

Risk of cancer in regular and low meat-eaters, fish-eaters, and vegetarians: a prospective analysis of UK Biobank participants: “In conclusion, this study found that being a low meat-eater, fish-eater, or vegetarian was associated with a lower risk of all cancer, which may be a result of dietary factors and/or non-dietary differences in lifestyle such as smoking. Low meat-eaters had a lower risk of colorectal cancer, vegetarian women had a lower risk of postmenopausal breast cancer, and men who were vegetarians or fish-eaters had a lower risk of prostate cancer. BMI was found to potentially mediate or confound the association between vegetarian diets and postmenopausal breast cancer. It is not clear if the other associations are causal or a result of differences in detection between diet groups or unmeasured and residual confounding. Future research assessing cancer risk in cohorts with large number of vegetarians is needed to provide more precise estimates of the associations and to explore other possible mechanisms or explanations for the observed differences.”

About healthcare IT

 Hims & Hers 2021 revenue jumps 83% as company expands retail collaborations: Announcements such as this one almost always lead with the rosy revenue data : “Hims & Hers grew its subscriptions by 95% in 2021, reaching 609,000 members as it significantly expanded into new categories and conditions over the past year.
The consumer telehealth and wellness brand's full-year revenue jumped 83% year over year to $272 million compared to $149 million in 2020.”
Then, way down in the article, you get a more meaningful assessment: “The digital health company's losses grew during the fourth quarter to a loss of $31 million compared to a loss $5.2 million a year ago. Hims & Hers' adjusted EBITDA for the quarter was a loss of  $7.1 million compared to a loss of $3.1 million for the fourth quarter 2020…
For 2021, the company's adjusted EBITDA was a loss of $30 million compared to a loss of $8 million in 2020. The company had been expecting a loss in the range of $35 million to $37 million.”
Are these announcements honest reporting?

About healthcare personnel

 17 'overpaid' healthcare CEOs: You decide: “Despite many CEOs cutting their base salaries last year due to the pandemic, those moves had little effect on overall CEO pay, according to an annual report from the nonprofit shareholder advocacy group As You Sow.”

About health technology

 Top 10 Health Technology Hazards for 2022: The annual list from EBRI. FYI, go to its website and check past lists for the evolution of changes in top hazards.
”1. Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety 
2.Supply Chain Shortfalls Pose Risks to Patient Care
3.Damaged Infusion Pumps Can Cause Medication Errors
4.Inadequate Emergency Stockpiles Could Disrupt Patient Care during a Public Health Emergency
5.Telehealth Workflow and Human Factors Shortcomings Can Cause Poor Outcomes
6.Failure to Adhere to Syringe Pump Best Practices Can Lead to Dangerous Medication Delivery Errors
7.AI-Based Reconstruction Can Distort Images, Threatening Diagnostic Outcomes
8.Poor Duodenoscope Reprocessing Ergonomics and Workflows Put Healthcare Workers and Patients at Risk
9.Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk
10.Wi-Fi Dropouts and Dead Zones Can Lead to Patient Care Delays, Injuries, and Deaths”

Today's News and Commentary

About Covid-19

 HHS Distributing $560 Million in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic: “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is making more than $560 million in Provider Relief Fund (PRF) Phase 4 General Distribution payments to more than 4,100 providers across the country this week.” 

About health insurance

 Judge strikes down part of Biden surprise billing rules in win for doctors: “A federal judge in Texas on Wednesday struck down part of the Biden administration’s regulations protecting patients from getting stuck with “surprise” medical bills when they see the doctor, in a win for doctors who sued to block part of the rules.
The ruling leaves in place the protections for patients against getting bills for thousands of dollars in situations such as going to the emergency room and later finding out one of the doctors was not covered by their insurance. 
But it strikes down part of the regulations that govern how much insurers will pay doctors once the patient is taken out of the middle.”

More African Americans have gained health insurance following adoption of the Affordable Care Act, HHS report finds: “Nearly 1 million Black American adults would become eligible for medical insurance if 12 holdout states expanded Medicaid eligibility under the ACA, according to the HHS report
From 2011 to 2019, the number of Black Americans without health insurance who were younger than 65 dropped from 7.1 million people to 4.4 million — or from about 20 percent of the Black population to 12 percent, the report said.
About 37 percent of Black Americans who are uninsured live in three states: Florida, Georgia and Texas. Florida and Georgia, according to the report, have high numbers of uninsured Black children.”

DOJ sues to block UnitedHealth-Change Healthcare deal: “In an announcement, the DOJ says that the deal would harm competition in commercial health markets as well as the market for technology that insurers use to process claims and reduce healthcare costs. The deal is valued at $8 billion in cash and $5 billion in debt.
The complaint was filed Thursday in U.S. District Court for the District of Columbia.”

AFTER MEDICARE’S 14.5% PRICE INCREASE, 60% OF SENIORS WILL FACE DIFFICULTY AFFORDING HEALTHCARE IN 2022: Key Findings

  • 18% of Medicare recipients say affording healthcare expenses will be “very difficult” following the Medicare price increase, while 42% say it’ll be “somewhat difficult”

  • 20% of Medicare recipients spend 50% or more of their monthly income on healthcare expenses

  • For those facing difficulty paying healthcare expenses, half will likely have to forgo some type of medical care in 2022

  • 27% of seniors who anticipate difficulty affording healthcare expenses may be forced to come out of retirement and get a job; 22% will consider continuing to work, despite retirement eligibility”

About hospitals and healthcare systems

Lifespan, Care New England scrap merger plans amid regulatory opposition: “The Federal Trade Commission and Rhode Island Attorney General’s Office sued to block the deal last week, claiming it would increase prices, reduce quality and stifle wages. Lifespan and Care New England decided not to appeal nor pursue a legislative workaround, such as a Certificate of Public Advantage.”

 Catholic Health hit with credit downgrade after 40-day strike: “Moody's Investors Service has assigned a ‘B1’ rating to Buffalo, N.Y.-based Catholic Health System's proposed revenue bonds and downgraded existing revenue bond ratings to ‘B1’ from ‘Baa2.’
‘The downgrade to 'B1' anticipates minimal cashflow and a further significant decline in liquidity this year, following material losses in fiscal 2021 from a 40-day labor strike and the disproportionately severe impact of the pandemic, both social risks under Moody's ESG classification,’ the credit rating agency said in a Feb. 17 report. 
Catholic Health System's rating outlook is negative.”

About pharma

Michigan signs PBM reform law with new transparency requirement: Another state action less than a week after the FTC failed to go forward with PBM investigations.
”The legislation prohibits PBMs from forcing pharmacists to sign gag clauses that prevent pharmacists from telling consumers it is cheaper to purchase drugs out-of-pocket and not through their insurance.
Michigan also will now require PBMs to get licenses and to file transparency reports with state officials to give consumers information on the ‘backend cost and profits of the medications they are prescribed’…
The law bans spread pricing where a PBM can drive up costs for reimbursing a pharmacist for prescription drugs and prohibits a PBM from charging a co-pay higher than the selling cost of the drug. The state is the 15th to ban spread pricing, according to data from the National Conference of State Legislatures.
In addition, PBMs cannot discriminate against any pharmacy solely because the carrier doesn’t have a vested interest in the pharmacy nor against any 340B covered entities.”

WHO creates training hub to boost pharmaceutical production in poor countries: “The World Health Organization is establishing a facility in South Korea to provide training for drug manufacturing in poorer countries to increase local production, combat chronic diseases and enhance preparation for the next global health crisis… Health experts have said the uneven distribution of vaccines worldwide was largely because of a lack of trained staff and the concentration of jab manufacturing in richer nations. The South Korean training hub will provide technical and hands-on training in the production of a range of pharmaceutical products, including vaccines, monoclonal antibodies and cancer treatments…”

Two related stories about different approval agencies:
FDA’s Pre-Approval Inspections Fell by More Than 50 Percent in 2021, Report Says
EMA Recommended 53 Medicines With a New Active Substance in 2021, up 35 Percent Over 2020

 Baxter reaches $18M settlement with SEC over decades of allegedly inflating income: “Baxter International will pay the U.S. Securities and Exchange Commission a penalty of $18 million after settling charges over the medtech giant’s alleged decades-long practice of improperly inflating its reported net income.
According to the SEC, from at least 1995 until 2019, Baxter converted its internal foreign transactions, assets and liabilities into U.S. dollars on its financial statements using a method that ‘was not in accordance with U.S. GAAP or generally accepted accounting principles.’”

About the public’s health

 Firearms: the leading cause of years of potential life lost: “Firearms are now the leading cause of YPLL [individual years of potential life lost] in trauma. Firearm deaths have overtaken MVC [motor vehicle crashes] as the mechanism for the main cause of potential years of life lost since 2017. Suicide in white males accounts for more YPLL than homicides. Deaths related to firearms are potentially preventable causes of death and prevention efforts should be redirected.” 

About healthcare IT

 Trends Shaping the Health Economy: TELEHEALTH: A great review from Trilliant. After all the hype, one statistic that stood out: “The total addressable market for telehealth is <1% of the health economy...and declining.

Today's News and Commentary

February 2022 Health Sector Economic Indicators Briefs: “National health spending for all of 2021 grew by 3.4%, reflecting significant federal government support in response to the COVID-induced recession in 2020 and a lower level of such support in 2021. Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover…
Including the federal support, health spending in December 2021 represented 18.8% of GDP; it was 17.8% of GDP if the additional government expenditures are excluded. For all of 2021, health spending represented 18.5% of GDP with the support and would have been 18.1% without it.”
See the article for February trends.

About Covid-19

Covid infections plummet 90% from U.S. pandemic high, states lift mask mandates: “The U.S. is reporting about 84,000 new cases per day on average, according to data compiled by Johns Hopkins University, down from a pandemic high of more than 800,000 daily cases on Jan. 15. And the decline is widespread across the nation, with average daily cases down by at least 40% in all U.S. regions over the past two weeks, according to a CNBC analysis of Hopkins data.
Hospitalizations have also fallen sharply. There are about 66,000 patients in U.S. hospitals with Covid as of Monday, according to a seven-day average of data from the Department of Health and Human Services, down from the Jan. 20 peak of 159,000 patients.”

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States: The CDC added “considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule.”

 Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants: “The 3-dose VE [ vaccine effectiveness] against hospitalization with Delta or Omicron was >99% across the entire study population. Our findings demonstrate high, durable 3-dose VE against Delta infection but lower effectiveness against Omicron infection, particularly among immunocompromised people. However, 3-dose VE of mRNA-1273 was high against hospitalization with Delta and Omicron variants.”

Sanofi, GSK to seek approval of COVID-19 vaccine: “Sanofi and GlaxoSmithKline said Wednesday that they plan to seek approval of their candidate COVID-19 vaccine following positive data from studies as both a primary series and booster. The companies noted that they are in discussions with the FDA and European Medicines Agency regarding submissions for the adjuvanted protein-based vaccine.
In the Phase III VAT08 trial, two doses of the vaccine in seronegative populations demonstrated 100% efficacy against severe COVID-19 disease and hospitalisations, as well as 75% efficacy against moderate or severe illness. Meanwhile, the vaccine offered 57.9% protection against any symptomatic COVID-19 disease.”

Rural hospitals stave off mass exodus of workers to vaccine mandate: “Rural hospital officials who expected Covid vaccine mandates to cause a staffing crisis are facing a pleasant surprise: Religious exemptions and education efforts for the hesitant are keeping almost all health care workers on the job.
Nearly two dozen rural hospital officials and state hospital association leaders told POLITICO they have lost just a fraction of their staff to the federal immunization requirement, which mandated that health care workers in every state except Texas received at least one shot of the vaccine by last week.”

Johnson & Johnson, Moderna set to face shareholder votes on vaccine pricing strategy, manufacturing tech sharing: “At J&J's upcoming annual meeting, shareholders will have a chance to vote on an Oxfam proposal to force the company to release its COVID-19 vaccine pricing strategy. Oxfam previously asked J&J to share the information considering the drugmaker received substantial funding assistance from the U.S. government while it was developing the shot. During the company's shareholder meeting last year, 32% of J&J's shareholders voted for a similar resolution…
Meanwhile, at Moderna, shareholders will vote on whether the company should study the feasibility of sharing vaccine technology to help increase global production.”

About health insurance

 Oregon agrees to sunset limit on benefits for kids on Medicaid: “In an email earlier this month, two top state officials said that in response to public feedback, Oregon will not seek to renew a waiver in its Medicaid plan that has allowed it to deviate from a federal standard, known as Early and Periodic Screening, Diagnostic, and Treatment, or EPSDT.
The EPSDT standard requires states to cover all medically necessary treatment for children on Medicaid, regardless of what services states provide to adults.
Oregon has been the only state with federal approval to take a different approach. It limits children’s coverage to a prioritized list of services determined by the legislature and a commission of medical experts appointed by the governor.
The agency is now saying that after a phase-out period, some medical treatments that the state has historically categorized as not prioritized for coverage will be funded on a case-by-case basis.”
This program highlights the great variations in care that are possible with a Medicaid waiver.

CMS ends ACO track in rural payment model: “CMS said Feb. 22 it is ending the ACO Transformation Track in the Community Health Access and Rural Transformation Model.
The ACO track was part of an alternative payment model for rural health system transformation, which was created by the Trump administration's HHS in 2020. The goal of the ACO track was to increase ACO adoption in rural areas.”
The CMS website lists only 4 participants in this program.

Association of Dual Medicare and Medicaid Eligibility [DE] With Outcomes and Spending for Cancer Surgery in High-Quality Hospitals: “The findings of this study indicate that, even among the highest-quality hospitals, DE patients had poorer outcomes and higher spending. Dually eligible patients were more likely to be discharged to a facility and therefore incurred higher postacute care costs. Although treatment at high-quality hospitals is associated with reduced differences in outcomes, DE patients remain at high risk for adverse postoperative outcomes and increased readmissions and postacute care use.”

About hospitals and healthcare systems

 Expenses push major health systems to operating margins under 1%: “Although hospital revenue and volume saw an upswing in the last quarter of 2021 — largely driven by COVID-19 hospitalization surges and higher-acuity patients — growing expenses are still offsetting gains in these areas for many hospitals…
 While [some] major hospital operators saw narrow operating margins, many ended the period with profits, mainly driven by nonoperating gains.
Many hospitals across the U.S. have been sounding the alarm over rising expenses. This has led the American Hospital Association to urge Congress to add $25 billion in additional relief to help providers across the nation address financial challenges attributed to surges tied to the omicron and delta variants.”

 About pharma

 California officials win an empty victory as they try to salvage a pay-to-delay law: “In a closely watched battle, California officials convinced a federal judge to modify a temporary hold on a law that bans so-called pay-to-delay deals between pharmaceutical companies, a contentious issue that has factored into the larger debate over the cost of prescription medicines. But as a practical matter, the ruling likely amounts to an empty victory for the state, because little may change. At issue is a law that went into effect in the fall of 2019 that made California the first state in the nation to outlaw pay-to-delay deals, a step California officials said was necessary to prevent drug companies from thwarting competition and maintaining higher prices. The move was also significant because California is generally seen as a bellwether state.”

Eli Lilly Launches Genetic Medicine and RNA-Focused Facility: “Eli Lilly has invested $700 million to launch a Boston, Mass., facility focusing on RNA-based therapeutics and genetic medicines.
Called the Lilly Institute for Genetic Medicine, the new site will focus on medicines acting at the nucleic acid level to advance a new class of drugs that target the root cause of diseases…
Genetic medicines already account for 20 percent of Lilly’s diabetes, immunology and central nervous system portfolio, but the goal is to push that further.”

GSK announces independent Consumer Healthcare company is to be called Haleon: “Haleon (pronounced ‘Hay-Lee-On’) is inspired by the merging of the words 'Hale', which is an old English word that means 'in good health' and Leon, which is associated with the word 'strength'. The new brand identity was developed with input from employees, healthcare practitioners and consumers and will be deployed in more than 100 markets around the world where the business operates.”

About the public’s health

 Task Force Issues Draft Recommendation Statement on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: From the USPTF: “People ages 40 to 75 who are at high risk for CVD should take a statin to prevent a first heart attack or stroke. This is a B grade. People ages 40 to 75 who are at
increased risk, but not at high risk, for CVD may benefit from statin use and should decide with their clinician if taking a statin is right for them. This is a C grade. More research is needed on whether people 76 or older should start taking a statin. This is an I statement. These recommendations only apply to people without a history of CVD and who are not already taking statins.
Grades in this recommendation:
B:  Recommended.
C:  The recommendation depends on the patient’s situation.
I: The balance of benefits and harms cannot be determined.”

Maternal Mortality Rates in the United States, 2020: “In 2020, 861 women were identified as having died of maternal causes in the United States, compared with 754 in 2019. The maternal mortality rate for 2020 was 23.8 deaths per 100,000 live births compared with a rate of 20.1 in 2019.
In 2020, the maternal mortality rate for non-Hispanic Black women was 55.3 deaths per 100,000 live births, 2.9 times the rate for non-Hispanic White women (19.1). Rates for non-Hispanic Black women were significantly higher than rates for non-Hispanic White and Hispanic women. The increases from 2019 to 2020 for non-Hispanic Black and Hispanic women were significant. The observed increase from 2019 to 2020 for non-Hispanic White women was not significant.”

Rural vs Urban Residents More Likely to Have Cancer Fatalism, Information Overload: “Rural residents were more inclined to believe that everything causes cancer (OR, 1.29; 95% CI, 1.17-1.43), prevention is not possible (OR, 1.34; 95% CI, 1.19-1.51), there are too many recommendations to prevent cancer (OR = 1.26; 95% CI, 1.13-1.41), and cancer is always fatal (OR = 1.21; 95% CI, 1.11-1.33) when compared with their urban counterparts. These concepts were referred to as the study’s ‘4 core beliefs…’
When comparing between rural and urban residents, investigators noted significant differences. Those in rural areas were older, White, and were more likely to be female, have lower income, abd be less educated. Additionally, the population was more likely to be retired, be receiving Medicare, married, a smoker, and classified as obese according to their body mass index.”

Racial Disparities in Dementia Diagnoses: “In studies across 39 Alzheimer’s Disease Research Centers (ADRCs) funded by the National Institute on Aging (NIA), the prevalence of dementia diagnoses at baseline visits was far greater among White individuals recruited for ADRC studies than Black recruits—despite population-based research showing that among people who are 65 years or older, Black individuals are more likely than those of other races and ethnicities to have Alzheimer disease and related dementias (ADRD).The findings, which demonstrate that participants enrolled in ADRC studies may not be representative of the general population of individuals with ADRD, were published in Alzheimer's & Dementia.”

About healthcare quality and safety

Sentinel Event Data—General Information & 2021 Update: From the Joint Commission. A must-read for those working in this area. By far, the single most frequent event category is falls, which largely accounts for the marked increase in sentinel events this past year.

About healthcare IT

 State of Telemedicine Report: From a Doximity survey. Some highlights:  “The percentage of patients who participated in a telemedicine visit in the past year jumped from 42% in 2020 to 67% in 2021. We found that patients with chronic illness adopted telemedicine earlier in the pandemic…
 58% of patients reported an intention to use telemedicine ‘more’ frequently or at ‘the same’ frequency after the end of the pandemic.
In 2021, over 73% of patients surveyed reported they planned to receive ‘some’ or ‘all’ of their care through telemedicine after the pandemic. It’s clear that telemedicine is now an expected part of their health-care experience, even as they think about life beyond the pandemic. Notably, this was consistent across race/ethnicity.”

Teladoc stock faces turbulence with shrinking Q4 losses but modest 2022 guidance: “The company reported a net loss of $10.9 million in the fourth quarter of 2021, or a loss of seven cents per share, dwarfing Wall Street’s projections of a loss of 59 cents per share.
That leaves Teladoc with a full-year loss of $428.8 million or $2.73 per share, compared with a loss of $485.1 million or $5.86 per share in 2020…
Teladoc also predicts losses to widen in the first quarter to between 50 and 60 cents per share.”

Oracle's waiting period to acquire Cerner has expired: “Under the Hart-Scott-Rodino Act, the waiting period for Oracle to acquire Cerner expired at 11:59 p.m. EST on Feb. 22.
Oracle's tender offer for Cerner shares remains under review.”
In a related article: CERNER REPORTS FOURTH QUARTER AND FULL YEAR 2021 RESULTS:
2021 Full Year Highlights

  • “Revenue of $5.765 billion, up 5% compared to $5.506 billion for 2020.

  • GAAP Operating Margin of 12.3%, down from 16.6% for 2020.

  • Adjusted Operating Margin (non-GAAP) of 21.7% up 180 basis points from 19.9% for 2020.

  • GAAP diluted EPS of $1.84, down 27% compared with $2.52 for 2020.

  • Adjusted Diluted EPS (non-GAAP) of $3.35 up 18% compared to $2.84 for 2020.

  • GAAP cash flow from operating activities of $1.772 billion, up 23% compared to $1.437 billion for 2020.

  • Free Cash Flow (non-GAAP) of $1.174 billion, up 37% compared to $857 million for 2020.

  • Share Repurchases of $1.500 billion at an average purchase price of $74.96.

  • Quarterly dividend increased by 23%.”

About healthcare personnel

 Surveyed nurses consider leaving direct patient care at elevated rates: “Thirty-two percent of registered nurses (RNs) surveyed in the United States in November said they may leave their current direct-patient-care role, according to McKinsey’s latest research. That is an increase of ten percentage points in under ten months.”

About health technology

 Permanente doctor helps create open-source O2 concentrator: A great story of a truly disruptive technology: “Family physician Ted O’Connell, MD, wants COVID-19 patients around the world to have access to unlimited oxygen if they need it. Anticipating that oxygen-equipment shortages would get to crisis levels during the pandemic, he provided clinical expertise for a small team of experts to help conceive an oxygen-concentrator kit—dubbed OxiKit—that people could use anywhere, with locally sourced materials.”

Medtronic's earnings flatten out as COVID pandemic, healthcare worker shortage rage on: “…as the year has gone on, the medtech giant has been set back by ever more variants of the virus, global supply chain and manufacturing issues and, most recently, a growing shortage of healthcare workers.
Those factors sent its second-quarter gains down to just about 3% and, now, have more than flattened revenues during the company's third fiscal quarter ended Jan. 28.
For the latest three-month period, Medtronic raked in $7.76 billion, about 1% lower than the previous quarter’s haul and 0.2% below its earnings for the same period in 2021.”

Today's News and Commentary

Global health champion Dr. Paul Farmer has died: “In 1987, Farmer co-founded Partners in Health in Haiti with the mission to provide high-quality care to patients from impoverished backgrounds and those living far from health care facilities. Over the next three decades, PIH expanded to countries across Africa and Latin America, to Russia and to the Navajo Nation in the United States.”

About Covid-19

Biden to extend U.S. national emergency due to COVID-19 health risk: “President Joe Biden said on Friday the U.S. national emergency declared in March 2020 due to the COVID-19 pandemic will be extended beyond March 1 due to the ongoing risk to public health posed by the coronavirus…
The emergency would have been automatically terminated unless, within 90 days prior to the anniversary date of its declaration, the president sent a notice to the Congress stating it is to continue beyond the anniversary date.”
And in a related article: Payers, Medicaid officials ask Congress for 90-day glide path to end of COVID-19 emergency: “Several major payer groups and Medicaid advocates are pressing Congress for a 90-day heads up when the COVID-19 public health emergency ends, arguing they need as much time as possible to make Medicaid enrollees aware they could lose coverage.”

New York State Department of Health Highlights Healthcare Workforce Booster Progress and Announces Additional Efforts To Bring Boosters Directly To Healthcare Workers: “In order to avoid potential staffing issues and give healthcare workers more time to get boosted, the State will no longer enforce the booster requirement that will go into effect on February 21.The State will reassess in three months whether additional steps need to be taken to increase booster rates among the healthcare work force. The original vaccination requirement for healthcare workers remains in effect.”

 The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects: “Two full years into the pandemic, the agency leading the country’s response to the public health emergency has published only a tiny fraction of the data it has collected, several people familiar with the data said….
Kristen Nordlund, a spokeswoman for the C.D.C., said the agency has been slow to release the different streams of data ‘because basically, at the end of the day, it’s not yet ready for prime time.’ She said the agency’s ‘priority when gathering any data is to ensure that it’s accurate and actionable.’
Another reason is fear that the information might be misinterpreted, Ms. Nordlund said.”

Got a Covid Booster? You Probably Won’t Need Another for a Long Time: “The Omicron variant can dodge antibodies — immune molecules that prevent the virus from infecting cells produced after two doses of a Covid vaccine. But a third shot of the mRNA vaccines made by Pfizer-BioNTech or by Moderna prompts the body to make a much wider variety of antibodies, which would be difficult for any variant of the virus to evade, according to the most recent study…”
In a related article: A fourth Covid-19 shot might be recommended this fall, as officials 'continually' look at emerging data: “In the United States, health officials emphasized late last year that fourth doses were not yet needed and said it was too premature to be discussing a potential fourth dose of coronavirus vaccine for most people.
Now, the US Food and Drug Administration ‘is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster doses,’ FDA spokesperson Alison Hunt wrote in an email to CNN on Friday.”

Estimated 73% of US now immune to omicron: Is that enough?: “The IHME [Institute for Health Metrics and Evaluation] estimates a wide range — from 63% to 81% of Americans.”
The answer to the headline’s question is not revealed in the article, which emphasizes the measurement difficulties in assessing immunity and the wide variation among estimates and localities.

About health insurance

 Early Changes in Billing and Notes After Evaluation and Management Guideline Change: “The American Medical Association updated guid- ance in 2021 for frequently used billing codes for outpatient eval- uation and management (E/M) visits. The intent was to account for provider time outside of face-to-face encounters and to reduce onerous documentation requirements…”
As a result of these changes, level 3 codes decreased slightly, while levels 4 and 5 increased slightly. “These changes varied by specialty. We found no meaningful changes in measures of note length or time spent in the EHR.”

About hospitals and healthcare systems

 342 hospitals have received price transparency noncompliance notices from CMS: “CMS told Becker's that no monetary penalties have been issued to date. The maximum penalty for noncompliance is $2 million.
’To date, each hospital that has come under compliance review has resolved its deficiencies, or is in the process of doing so,’ CMS said. ‘Therefore, it has not been necessary for CMS to issue any penalties.’”

Ascension's operating margin falls below 1% in Q2: “Although the health system's overall revenue decreased, its expenses increased year over year to just under $7.3 billion. In the same period last year, Ascension's expenses totaled $6.7 billion.” 

About pharma

 Risk Factors and Hospital-Level Characteristics With Medicare Part B Drug Spending Differences Between 340B and Non-340B Hospitals: “In this cross-sectional study that included 35 364 beneficiaries and 2446 hospitals, there was no statistically significant difference in Medicare Part B drug spending between 340B hospitals and non-340B hospitals, after controlling for beneficiary-level risk factors and hospital-level characteristics.
Meaning  These findings raise doubt about the financial incentive theory of 340B program drug discounts and the Centers for Medicare & Medicaid Services’ 340B drug payment policy rationale.”

The top 10 biotech IPOs of 2021: FYI

About the public’s health

 New DNA computer assesses water quality: Genetic networks mimic electronic circuits to perform a range of logic functions: “Northwestern University synthetic biologists have developed a low-cost, easy-to-use, hand-held device that can let users know — within mere minutes — if their water is safe to drink.
The new device works by using powerful and programmable genetic networks, which mimic electronic circuits, to perform a range of logic functions.”

Raw and Cooked Vegetable Consumption and Risk of Cardiovascular Disease: A Study of 400,000 Adults in UK Biobank: “Higher intakes of raw, but not cooked, vegetables were associated with lower CVD risk. Residual confounding is likely to account for much, if not all, of the observed associations. This study suggests the need to reappraise the evidence on the burden of CVD disease attributable to low vegetable intake in the high-income populations.”

About healthcare IT

Electronic Medical Records in Healthcare: An excellent monograph on the security of EHRs, from the HHS Office of Information Security.

Hospitals should be wary of these 5 cyberthreats: “Cyberattacks on healthcare organizations remain frequent, as nearly 2 million health records were breached in the U.S. in January.” The article explains five significant cyberthreats, according to recent federal advisories.

 About healthcare personnel

 Physician Burnout & Depression Report 2022: Stress, Anxiety, and Anger: The top three on the burnout list are emergency, critical are and OB/GYN physicians. At les than half the rate, at the bottom, are public health and preventive medicine practitioners.

6 schools launching nursing programs: Examples of 6 organizations launching or expanding programs.

American Healthcare Workers Persevering, but Remain Stressed: Highlights from the poll:

  • Four in five (80%) of healthcare workers report being somewhat or very satisfied with their current job, down slightly from the 89% saying the same in a Spring 2021 Kaiser Family Foundation/Washington Post poll.

  • Three quarters (73%) agree with the statement “I love working in healthcare”.

  • A majority report feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. However, the number saying hopeful (to 59% from 76%) or optimistic (to 56% from 67%) is down compared to last year.

  • About half (52%) report feeling “burned out”, on par with the 2021 numbers (55%).

  • Over a third (39%) report agreeing with the statement “the American healthcare system is on the verge of collapse”.

  • A third either disagree (16%) or don’t know how they feel (18%) regarding if they could pick a career over again, “I would still decide to go into health care”.

  • A quarter of healthcare workers (23%) say they are likely to leave the field in the near future.[Emphasis added]

About health technology

 The top 10 medtech IPOs of 2021 : FYI

Today's News and Commentary

About Covid-19

 Cuba's vaccine coverage and focus on children helped beat back Omicron, experts say: Lessons from another country that developed its own vaccine:
”Omicron arrived in Cuba in December but fell far short of the pronounced spike in cases seen in many other places and infections have since fallen off by more than 80%, official data shows.
Deaths have remained at around 10% or less of their peak throughout the Omicron wave, according to a Reuters tally…
Health workers on the Caribbean island have since fully inoculated 1.8 million children between 2 and 18 years of age, or upwards of 96% of the total, with no serious side effects reported, according to official Cuban data…
Cuba has fully vaccinated 87% of its total population, and nearly 94% have received at least one dose, placing it among the top three globally among countries of at least 1 million people, according to official statistics compiled by ‘Our World in Data.’”

Racial, Ethnic Divide in U.S. Views of Pandemic, Healthcare: “Nearly seven in 10 Black adults (69%) and Hispanic adults (68%) are very or somewhat stressed about contracting COVID-19, compared with 57% of White adults, according to a survey by West Health and Gallup…
The West Health-Gallup study highlights continued disparities in access to healthcare and in health outcomes in the U.S. Black Americans (8%) are twice as likely as White Americans (4%) to say they know someone who has died in the past year due to an inability to pay for treatment.
At the same time, Americans across racial and ethnic groups agree that healthcare is too expensive and that costs do not match the quality of care. More than 90% of adults among each group say the general cost of care is too high and that they pay too much for the quality of care they receive, and about 70% indicate that healthcare costs are a financial burden for them. Additionally, 51% of U.S. adults overall -- including 51% of White, 47% of Black and 56% of Hispanic adults -- say the cost of healthcare causes them daily stress.”

About health insurance

 CMS to launch new special enrollment period in late March: “The Centers for Medicare & Medicaid Services plans in late March to launch at the federally facilitated health insurance marketplace a new monthly special enrollment period for consumers with household incomes below 150% of the federal poverty level who aren’t eligible for Medicaid or the Children’s Health Insurance Program.”

About hospitals and healthcare systems

Medicare Paid $6.6 Billion In Non-Hospice Care For Hospice Patients: “Medicare may be paying twice for some items and services provided to hospice patients, according to a Health and Human Services Department Office of Inspector General report Wednesday. 
Medicare claims data shows the government paid out $6.6 billion in non-hospice claims for hospice patients between 2010 and 2019, primarily from costs associated with for-profit hospices. The findings indicate that Medicare could be double paying for these services if providers bill for non-hospice items and services that should already be covered through the hospice bundle, the OIG report said.”

 FTC, Rhode Island AG will sue to block Lifespan, Care New England merger: “Rhode Island Attorney General Peter Neronha has denied the application for the proposed merger between Lifespan and Care New England and said he will join the Federal Trade Commission in filing a lawsuit challenging the deal…”

AHIP study claims hospitals charge double for specialty drugs compared to pharmacies: “Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry.
The study…, by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products.”

About pharma

 Pharmacy Middlemen Dodge FTC Competition Probe in Split Vote: “The Federal Trade Commission Thursday failed to reach consensus on launching a study into the reimbursement rates set by the entities that manage prescription drug benefits on behalf of health insurers and Medicare Part D plans. 
The FTC in a 2-2 party-line vote decided to not open a probe into pharmacy benefit managers (PBMs) and whether their drug price setting practices unfairly favor PBM-affiliated pharmacies at the expense of independent or specialty ones. 
The move comes despite fervent demands from pharmacy and patient advocacy groups to look into a complex component of the health-care industry that has traditionally remained without strong federal oversight.”

Teva Suffers Another Blow in ‘Skinny Labeling’ Case Against GSK: “A federal appeals court has upheld a decision ordering Teva Pharmaceuticals to pay $235.5 million to GlaxoSmithKline for infringing on the latter’s patent for its congestive heart failure drug Coreg (carvedilol).
The U.S. Court of Appeals for the Federal Circuit, in a 7-to-3 ruling, rejected Teva’s request to convene a new hearing on the case.
The decision has implications for the future of “skinny labeling” — a practice allowed under the Hatch-Waxman Act of 1984, which enables generics makers to manufacture a patented brand-name drug for certain narrow indications not covered by the patent.
Teva said it will seek a Supreme Court review of its case.”

BREAKING: Sacklers Offer Another $1.6B For Purdue Ch. 11 Settlement: The headline is the story.

About healthcare IT

 Overuse and Underuse of Health Care: New Insights From Economics and Machine Learning: Read the whole article; but here are some good takeaways:
”Comparing algorithmic predictions to physicians’ decisions reveals substantial overtesting.1About two-thirds of tests were performed on patients with predictably low risk, making the tests extremely low value—some costing up to $1 million per life-year saved. But, critically, we also find substantial undertesting, with predictably high-risk patients going untested and then having adverse outcomes of missed ACS, including death. These findings suggest that reallocating low-value tests to high-risk untested patients could save lives, at a cost of only $46 017 per life-year…
 So it is no surprise that higher across-the-board testing has little aggregate health benefit because most patients are low risk. But for the small fraction of predictably high-risk patients, we find a dramatic reduction in adverse events and death—34% lower 1-year mortality—when they arrive during higher-testing shifts.1 We estimate that the optimal policy would cut testing by 46.8% overall, but with a 62.4% reduction in the tests physicians currently do and a 15.6% increase in testing for patients who currently go untested.”

About health technology

 Foundation Medicine’s FoundationOne Cancer Tracker Named Breakthrough Device: “Foundation Medicine’s circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker, has been granted the FDA’s Breakthrough Device designation.
The assay uses algorithms to identify patient-specific variants that allows for the detection of ctDNA in plasma. The Breakthrough Device designation covers the assay’s use in the detection of residual disease in early-stage cancer after curative therapy.”

 

Today's News and Commentary

About Covid-19

 CDC expected to update mask guidance as early as next week: “The Centers for Disease Control and Prevention is expected to loosen its indoor masking guidelines to states soon, according to several people familiar with the matter. The agency’s update could come as early as next week.
Dr. Rochelle Walensky, the director of the CDC, is expected to discuss masking guidance [next] Wednesday at a White House Covid-19 Response Team briefing.”

Texas Republicans sue Biden administration over airline mask mandates: “Attorney General Ken Paxton (R), U.S. Rep. Beth Van Duyne (R-Tex.) and their allies argue that the mandates were unlawfully issued because they weren’t approved by Congress. They also say the CDC didn’t place the mask order up for notice and comment, which Paxton and others say is ordinarily required for such regulations.”

Ex-NIH chief Collins returns as science adviser to Biden weeks into retirement: “That was quick. Francis Collins, M.D., Ph.D., after exiting the top perch at the National Institutes of Health (NIH) in the last weeks of 2021, is back in the upper echelons of U.S. scientific leadership as President Joe Biden's science adviser.
Collins also assumes the role of co-chair of Biden's Council of Advisors on Science and Technology…
Alongside Collins' appointment, Biden promoted Alondra Nelson, Ph.D., to director of the White House Office of Science and Technology Policy, or OSTP. Nelson was previously deputy director for science and society at the OSTP. Nelson was also president of the Social Science Research Council from 2017 to 2021.
Nelson and Collins are filling a vacancy left by Eric Lander, who resigned from his post last week after a White House investigation found evidence that he violated workplace conduct rules by demeaning his staff.” 

About health insurance

 State to merge health insurance markets in bid to help small businesses: A new approach to ACA exchanges: “The state will merge the Affordable Care Act insurance markets for individuals and small groups to create more stable pricing for health coverage, particularly needed among the declining group market used by small businesses.
Maine will be first in the nation to combine the two markets into a subsidized reinsurance program, officials said. The merger was authorized by the Made for Maine Health Coverage Act, signed into law by Gov. Janet Mills in 2020.”

BCBS of Louisiana to face antitrust suit over rates: “The initial lawsuit, which seeks class action status, was brought by Opelousas General Hospital Authority in 2016. In it, the hospital authority alleges Blue Cross and Blue Shield of Louisiana violated antitrust laws by leveraging discounted rate reimbursements created by its BlueCard Program. 
The program allows Blue Cross Blue Shield members to receive care from facilities in other states at a discounted rate, according to the lawsuit. When a patient visits a facility outside of its plan's network but in-network with another Blue Cross Blue Shield affiliate, they pay a rate equivalent to those negotiated with in-network providers in their state's plan.”

UnitedHealth Wants High Court Review Of Medicare Rule: “UnitedHealth Group is asking the U. S. Supreme Court to review a Medicare Advantage overpayment rule that has multibillion-dollar implications for insurer reimbursement and False Claims Act enforcement, calling a D. C. Circuit opinion against it ‘egregiously wrong.’ In its Monday petition to the high court, UnitedHealth said the justices should take up its challenge to an August D. C. Circuit reversal of a lower court decision that vacated the rule. The clawback rule at issue requires Medicare Advantage insurers to return excess payments within 60 days.”

Biden administration to reverse the Trump-era 'public charge' rule that denied green cards to poor immigrants: “The Biden administration is throwing out the Trump administration's "public charge" rule, which denied permanent residency to immigrants who used public assistance programs or were suspected of using them in the future.
Department of Homeland Security Secretary Alejandro Mayorkas on Thursday said in a statement the 2019 rule’was not consistent with our nation's values.’”

About hospitals and healthcare systems

New Data Finds 69% of Americans Would Consider Switching Healthcare Providers for More “Appealing” Services – Same Day Appointments Top the List: “Some Americans might say they are pleased with their current healthcare provider, but a new Tegria survey conducted by The Harris Poll reveals that nearly 7 in 10 Americans (69%) would consider switching to another provider that offers more appealing services. Top drivers that could inspire people to switch include the availability of same-day appointments for non-routine issues (35%), convenient locations where they already go (30%) and self-scheduling (29%). In fact, more than 4 in 5 Americans (81%) believe the ability to schedule healthcare appointments online would make the scheduling process much easier and more than three quarters (79%) want the ability to use technology when managing their healthcare experience.”

 Baylor Scott & White's operating income dips 13% as expenses climb: “Dallas-based Baylor Scott & White saw its operating income fall more than 13 percent in the six months ending Dec. 31, largely driven by an increase in expenses, according to recently released financial results. 
For the first half of fiscal year 2022, Baylor Scott & White recorded an operating income of $644 million, down from the $742 million recorded in the same period one year before. The health system's operating margin was 10.2 percent for the first half of fiscal 2022. In the same period in fiscal 2022 the operating margin was 12.8 percent…
The health system also saw its expenses rise in the first half of fiscal 2022 to $5.7 billion, up 12.6 percent from the same period in fiscal 2021. The health system attributed the expense jump to rising costs for employee wages and supplies.”

About pharma

 Judge sides with AstraZeneca in 340B dispute: “A federal judge ruled Feb. 16 that HHS violated procedural rules by compelling AstraZeneca to resume drug discounts for hospitals participating in the 340B program… In May 2021, HHS notified six drugmakers, including AstraZeneca, that they were in violation of 340B requirements by restricting discounts for hospitals that use contract pharmacies. In the warning letter, HHS said the drugmakers must immediately begin offering their drugs at discounted prices or potentially face civil monetary penalties.”

Generic drug approvals continued to fall in 2021: “The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.
In calendar year 2020, FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019. The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report.

Statin intolerance is 'over-estimated and over-diagnosed': World’s largest study shows less than 10% suffer side-effects caused by the drug: “As many as one in two patients stop taking statins, reduce the dose or take them irregularly because they believe the cholesterol-lowering drugs cause muscle pain and other side-effects. Now, a new study of over four million patients has shown that the true prevalence of statin intolerance worldwide is between six to ten percent.
The authors of the research, published in the European Heart Journal, say that their findings show that statin intolerance is over-estimated and over-diagnosed, with the result that patients are at greater risk of heart and blood vessel problems, including death, caused by high cholesterol levels.”

Teva takes 'skinny' label dispute with GlaxoSmithKline to the Supreme Court: reports: “The case comes down to ‘skinny’ labeling, a popular type of carve-out in the world of copycat drugmakers. For decades, generic drugmakers have been able to get their copycats approved for one or several–but not necessarily all–approved indications of their brand-name counterparts. If a generic doesn’t cover all the indications of its reference product, then its label is ‘skinny.’
Branded companies, for their part, argue that pharmacists sometimes ignore the skinny labels, leading to infringement when patients take generics for unapproved indications.” 

About the public’s health

 Recommended Adult Immunization Schedule, United States, 2022: FYI

About healthcare IT

 Top 15 specialties for telehealth: “Telehealth adoption rates are highest for specialties that manage chronic illness, according to the "State of Telemedicine" report released Feb. 16 by health IT and telehealth networking platform Doximity.”
At the top is endocrinology.

Today's News and Commentary

About Covid-19

Israel finds fourth Covid jab cuts infection and serious illness: “Initial data in January from the Sheba Medical Center at Tel Hashomer suggested that the fourth dose made little difference in protecting against Omicron, and even though the jabs are now available for many population groups, diminishing numbers of Israelis are opting for the fourth jab.
However, Maccabi Health Services virus task force head Dr. Arnon Shahar said, ‘We see that when the fourth vaccine dose is freshly administered, up to six weeks, it reduces infection by 50% and the risk of serious illness is five times less.’
Israeli Ministry of Health figures show that 7% of those hospitalized in serious and critical condition with Covid had four Covid vaccinations compared with 28% who have had three jabs, with the third vaccination not administered recently, while 45% have not been vaccinated at all.”

Hospitalizations of Children and Adolescents with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, July 2021–January 2022: “Coinciding with increased circulation of the Omicron variant, COVID-19–associated hospitalization rates among children and adolescents aged 0–17 years increased rapidly in late December 2021, especially among children aged 0–4 years who are not yet eligible for vaccination. Throughout the periods of Delta and Omicron predominance, hospitalization rates remained lower among fully vaccinated adolescents aged 12–17 years than among unvaccinated adolescents.”

Excess Deaths Associated with COVID-19: Per CDC data: “Total predicted number of excess deaths since 2/1/2020 across the United States: 1,045,389”

Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022: “Effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization among infants aged <6 months was 61% (95% CI = 31% to 78%). Effectiveness of completion of the primary COVID-19 vaccine series early and later in pregnancy was 32% (95% CI = –43% to 68%) and 80% (95% CI = 55% to 91%), respectively.”

Covid-19 booster shot uptake is at all-time low in the US, CNN analysis finds: “As of Monday, about 64% of the US population is fully vaccinated against Covid-19 with at least their initial two-dose series, and 28% have received a booster shot. But the pace of booster doses going into arms is the lowest it has been in months -- since the US Centers for Disease Control and Prevention first recommended boosters for seniors and other at-risk adults in September, according to a CNN analysis of CDC data. The agency expanded its recommendation for booster doses in November to include all adults.” 

Biden admin seeks $30 bln more from Congress to fight COVID -sources: “The $30 billion request includes $17.9 billion for vaccines and therapeutics, two sources familiar with it said.”

COVID-19 therapeutics for nonhospitalized patients: Sorting out these therapies is often confusing.
eTable 1 provides a great comparison among these treatments.

About health insurance

 Fraud Section Year in Review-2021- From the Department of Justice. The healthcare report begins on page 15. In short:
”The Department announced criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals, charged between August 1 and September 17, 2021, in 31 federal districts for their alleged participation in various health care fraud and illegal opioid distribution schemes that resulted in a combined total of approximately $1.4 billion in alleged losses. The charges targeted approximately $1.1 billion in alleged fraud committed using telemedicine (the use of telecommunications technology to provide health care services remotely), $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, or ‘sober homes,’ and $160 million connected to other health care fraud and illegal opioid distribution schemes across the country.”

About hospitals and healthcare systems

 CommonSpirit Health reports $81M operating loss as COVID surges drove up supply, staffing costs: “CommonSpirit’s net patient and premium revenue for the second quarter increased 9.3% ($710 million) year over year, while same-store adjusted admissions rose 1.5% year over year, outpatient visits rose 5.1% year over year and emergency department visits jumped 16.6% year over year. Total operating revenue for the quarter was $8.88 billion.
 But the health system also saw a 12.3% year-over-year increase in labor expenses per adjusted admission and an 11.6% ($152 million) rise in supply costs.”

About pharma

HOW DO COPAYMENT COUPONS AFFECT BRANDED DRUG PRICES AND QUANTITIES PURCHASED?: “Using data on net-of-rebate prices and quantities from a large Pharmacy Benefits Manager, we find that coupons increase quantity sold by 21-23% for the commercial segment relative to Medicare Advantage in the year after introduction..
For this category of drugs, we estimate that coupons raise negotiated prices by 8% and result in just under $1 billion in increased U.S. spending annually. Combined, the results suggest copayment coupons increase spending on couponed drugs without bioequivalent generics by up to 30 percent.”

Identifying Higher-Volume Antibiotic Outpatient Prescribers Using Publicly Available Medicare Part D Data — United States, 2019: “The highest 10% of antibiotic prescribers prescribed 41% of total antibiotic prescriptions for Medicare Part D beneficiaries in 2019. The antibiotic prescribing rate of these higher-volume prescribers was 60% higher than that of lower-volume prescribers.”

 FDA wallops Indian drugmaker with warning letter blasting API quality, equipment cleanliness and more: “The FDA has dinged Indiana Chem-Port with a laundry list of problems related to controls, cleaning, maintenance, testing and quality assurance in its API [active pharmaceutical ingredient] production operation. The regulator handed down a five-observation warning letter earlier this month after inspecting Indiana Chem-Port’s Gujarat, India, manufacturing facility in August last year.”
The reason this action is important is that India, with China, are the top two sources for our APIs.

Merck & Co. inks drug-development deal with Curve Therapeutics: “Merck & Co. entered into an agreement with Curve Therapeutics potentially worth up to $1.7 billion to develop modulators of up to five therapeutic targets, initially for oncology and neurology indications, the latter company said Wednesday. Along with an undisclosed upfront payment and milestones, Curve is also eligible to receive sales royalties on any approved products resulting from the alliance.
Under the deal, Curve will perform high throughput mammalian cell-based functional screening, hit characterisation, data-mining and analysis, as well as optimisation using its Microcycle technology.”

About the public’s health

 Validation Status of Blood Pressure Measuring Devices Sold Globally: The state of the art for blood pressure monitoring is ambulatory self-measurement, However, validation of devices has not been performed on a wide scale. Disturbingly, this global study found:
”From 2486 upper arm cuff devices, 248 (10.0%) were validated, 327 (13.2%) were equivalent, and there was no evidence of validation for 1816 (73.0%) (Table). From 925 wrist-based devices, 52 (5.6%) were validated, 51 (5.5%) were equivalent, and there was no evidence of validation for 786 (85.0%)…
Lack of validation may undermine optimal medical practice through increased potential for incorrect hypertension diagnosis and inappropriate care. Global and national policy frameworks, including regulations with enforcement, are needed, with the goal that all devices meet minimum requirements for independent validation before premarket clearance. Currently, to determine if a device is validated, consumers should check a validated device list.” See: How to check whether a blood pressure monitor has been properly validated for accuracy

About healthcare IT

 athenahealth Acquired by Hellman & Friedman and Bain Capital: “athenahealth, Inc. (“athenahealth” or “the Company”), a leading provider of cloud-based enterprise software solutions for medical groups and health systems nationwide, today announced that affiliates of Bain Capital and Hellman & Friedman have completed their acquisition of athenahealth from Veritas Capitaland Evergreen Coast Capital for $17 billion.”

HHS awards community health centers $55M to expand telehealth access for underserved groups: “The Department of Health and Human Services has awarded community 29 health centers nearly $55 million to reach their underserved populations using telehealth, remote patient monitoring, health information technology platforms and other digital and virtual care tools.
The funds announced Monday will be distributed through the Health Resources and Services Administration (HRSA) and aim to ‘enable health centers to sustain an expanded level of virtual care and identify and implement new digital strategies.’”

Mobile Health App Use Among Older Adults: “Nearly three in ten adults age 50–80 (28%) said they currently use at least one mobile health app, 16% reported that they used them in the past but not currently, and 56% have never used a health app. Adults age 50–64 were more likely than those 65–80 to have ever used a health app (49% vs 38%). Overall, 34% of older adults said they use or have used apps for exercise, 22% for nutrition, 20% for weight loss, and 17% for sleep. Older adults less commonly used apps for recording blood pressure (9%), meditating (8%), and/or mental health/stress management (5%).”

About health technology

 Cleveland Clinic Unveils Top 10 Medical Innovations for 2022: Each year the Cleveland Clinic publishes its “top 10 list”—always worth reading. 

Today's News and Commentary

To readers: For some reason, yesterday’s blog, while sent, was lost.

It is duplicated first below

TODAY'S NEWS AND COMMENTARY

February 14, 2022

About Covid-19

 Federal vaccination mandate begins for healthcare workers in 24 states“Healthcare facilities in 24 states face their first deadline Feb. 14 to comply with the Biden administration's COVID-19 vaccination mandate.”

Almost 1 in 3 older adults develop new conditions after covid-19 infection“Almost a third (32 of every 100) of older adults infected with covid-19 in 2020 developed at least one new condition that required medical attention in the months after initial infection, 11 more than those who did not have covid-19, finds a US study published by The BMJ today.
Conditions involved a range of major organs and systems, including the heart, kidneys, lungs and liver as well as mental health complications.”

CDC recommends people with weakened immune systems get booster doses after three months instead of five“The Centers for Disease Control and Prevention updated its guidance on Friday for some people with weakened immune systems, recommending they get a booster dose of the coronavirus vaccine three months after completing the initial series of the Pfizer-BioNTech or Moderna shots, rather than the current interval of five months.
The guidance also said immunocompromised people who received the one-shot Johnson & Johnson vaccine should get an additional dose. That means two doses, at least 28 days apart, followed by a booster dose of one of the mRNA vaccines.”

About health insurance

UnitedHealth was 2021's most profitable payer. Here's a look at what its competitors earned: A quick look at financial performance for the industry’s top players.

 Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme“According to court documents and evidence presented at trial, Mark Agresti, M.D., 59, of Palm Beach, unlawfully billed approximately $110 million of urinalysis (UA) drug testing services that were medically unnecessary for patients at a sober living facility, Good Decisions Sober Living (GDSL). GDSL was paid kickbacks for providing patients to addiction treatment facilities in the West Palm Beach area, in violation of Florida state law.”

Association Between High-Deductible Health Plans [HDHPs] and Hernia Acuity “In this cohort study that included 83 281 patients from a large commercial insurance claims database, the study team found that those enrolled in individual HDHP coverage were at 6% higher odds of presenting with an incarcerated or strangulated hernia.
Meaning  Among patients with groin and ventral hernias, enrollment in an HDHP may be associated with delays in surgical care that may result in complex disease presentation.”

About hospitals and healthcare systems

CMS claws back Medicare payments from hospitals that own nursing schoolsFor nearly a decade, the federal government has overpaid hospitals that own nursing schools an estimated $310 million, and now the Centers for Medicare and Medicaid Services want that money back. CMS posted a notice online in late 2020 stating that due to an agency error, nursing schools were overpaid by Medicare from 2008 through 2018 and needed to return that money. For many of the providers, that money will come due this summer unless a congressional effort to forgive the debts is successful.”

 CMS delays hospital star ratings update until July“CMS is postponing its next Overall Hospital Quality Star Ratings update from April to July to fix a calculation error…
The error involved calculations using 2021 hospital data for the OP-10 outpatient imaging efficiency measure.”

Mass General Brigham's operating income falls to $10M in Q1“Although Boston-based Mass General Brigham reported higher revenue in the first quarter of fiscal year 2022, its operating income fell, according to recently released financial documents…”
’We are continuing to address longstanding capacity challenges for our patients, severely exacerbated by deferred care and a staffing crisis during the latest COVID-19 surge,’ Mass General said.”

Catholic Medical Center Agrees To Pay $3.8M For Kickback-Related False Claims“According to the settlement agreement, the United States asserted that CMC, a hospital in Manchester, paid its own cardiologists to cover for, and to be available to provide medical services for, another cardiologist’s patients when she was on vacation or otherwise unavailable. The United States further alleged that CMC provided these call coverage services at no charge. The cardiologist who received the free call coverage referred millions of dollars in medical procedures and services to CMC over the decade in which the free services were provided. Because CMC submitted claims for payment to Medicare, Medicaid, and other federal health care programs for the services referred by the cardiologist, the United States alleged that these claims were the result of unlawful kickbacks.”

Kaiser Permanente Broke Its Own Profit Record In 2021“Kaiser Permanente had its most profitable year yet in 2021, drawing $8.1 billion in net income.
Oakland, California-based Kaiser once again benefited from strong investment returns last year, beefing up its nonoperating income even as its operating income grew slimmer. The integrated health system’s net income grew 27.2% year-over-year, from an already strong $6.4 billion in 2020.”

 About healthcare IT

 WHO: It’s Time to Eliminate Ageism in Artificial Intelligence“As caregivers examine how artificial intelligence (AI) can improve healthcare for seniors, a policy brief by the World Health Organization shows that potential issues can be eliminated by taking various steps, including optimal design and data collection, providing resources, and maintaining good moral codes.
The most common uses of healthcare-focused AI for seniors are remote patient monitoring, which is used as a method of community care, and the production of drugs for aging patients. The report… also stated that optimizing AI capabilities can increase hospital capacity, as beds can be reserved for cases requiring hands-on care.” 

Healthcare clearinghouse to pay $1.12M to settle data breach“nmediata Health Group agreed to pay $1.12 million to resolve allegations it put patients at risk during a 2019 data breach that affected 1.5 million people, Top Class Actions reported.
Inmediata is a Puerto Rico-based healthcare clearinghouse. It ensures providers' medical claims are error-free so payers can accurately process them.”

Doximity brings in record profit in Q3, snaps up Amion to add physician scheduling to its platform“Doximity, a digital platform for medical professionals, brought in $98 million in revenue in the third quarter, a 67% jump from a year ago. The health tech company also boasted a record profit of $56 million during the quarter, up from $17.2 million just one year ago. 
Doximity, which went public in June, operates like a LinkedIn for doctors and provides a digital platform for U.S. medical professionals, including telehealth and scheduling tools. The company has over 1.8 million medical professional members as of March 31, 2021, and claims to have more than 80% of doctors on its network.”

About healthcare personnel

‘A real crisis’: License backlogs in some states are preventing health care workers from seeing patients“In some states, though, licensing delays and their impacts are clear. NBC News spoke to the leaders of nine health care professional organizations in three states who said wait times for licenses are worse than they’ve ever been. Licensing agencies that were already slow and understaffed were put under additional pressure by the pandemic. They’ve dealt with an influx of applicants, had to adapt antiquated paper-based application systems to remote work and built emergency licensing processes nearly overnight. In 2021 and 2022, they’ve lost staff to the Great Resignation.”

 

HERE IS TODAY’S POST

About Covid-19

 Moderna, Pfizer stocks fall as omicron Covid wave subsides in U.S.: “Shares of the major Covid vaccine makers fell on Monday, as the unprecedented wave of omicron infections eased, with new cases rapidly dropping across the country.
Moderna plunged more than 11%, the biggest decline in the S&P 500 Monday. Pfizer tumbled nearly 2% and its partner BioNTech slid more than 9%, while Novavax was off more than 11% and Johnson & Johnson fell over 1%.
White House chief medical advisor Dr. Anthony Fauci told The Financial Times last week that the U.S. is exiting the ‘full-blown pandemic phase of Covid-19.’”

CDC recommends people with weakened immune systems get booster doses after three months instead of five: “The Centers for Disease Control and Prevention updated its guidance on Friday for some people with weakened immune systems, recommending they get a booster dose of the coronavirus vaccine three months after completing the initial series of the Pfizer-BioNTech or Moderna shots, rather than the current interval of five months.
The guidance also said immunocompromised people who received the one-shot Johnson & Johnson vaccine should get an additional dose. That means two doses, at least 28 days apart, followed by a booster dose of one of the mRNA vaccines.”

Almost 1 in 3 older adults develop new conditions after covid-19 infection: “Almost a third (32 of every 100) of older adults infected with covid-19 in 2020 developed at least one new condition that required medical attention in the months after initial infection, 11 more than those who did not have covid-19, finds a US study published by The BMJ today.
Conditions involved a range of major organs and systems, including the heart, kidneys, lungs and liver as well as mental health complications.”

Stroke risk among older adults highest in first 3 days after COVID-19 diagnosis: “Research Highlights:

  • The risk of stroke among older adults diagnosed with COVID-19 was greatest within the first three days of being diagnosed with the virus.

  • The risk of stroke was higher among adults ages 65-74 years old, compared to those 85 and older, and among those without a history of stroke.”

Eagerly awaited COVID lifesavers molnupiravir, Paxlovid now wait for patients: “Supplies of the eagerly awaited oral COVID-19 antiviral prescription medications are slowly arriving at US pharmacies, but despite strong evidence that they can help reduce symptoms and prevent severe illness, federal data and experts suggest that many patients don't know about them or don't want to take them.
Two oral COVID-19 antiviral medications, molnupiravir (Merck) and Paxlovid (nirmatrelvir and ritonavir, Pfizer), have been proven to be safe, effective, and convenient treatments to take at home.”

About health insurance

 Why Millions on Medicaid Are at Risk of Losing Coverage in the Months Ahead: “Before the public health crisis, states regularly reviewed whether people still qualified for the safety-net program, based on their income or perhaps their age or disability status. While those routines have been suspended for the past two years, enrollment climbed to record highs. As of July, 76.7 million people, or nearly 1 in 4 Americans, were enrolled, according to the Centers for Medicare & Medicaid Services.
When the public health emergency ends, state Medicaid officials face a huge job of reevaluating each person’s eligibility and connecting with people whose jobs, income, and housing might have been upended in the pandemic. People could lose their coverage if they earn too much or don’t provide the information their state needs to verify their income or residency.”

Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme: “According to court documents and evidence presented at trial, Mark Agresti, M.D., 59, of Palm Beach, unlawfully billed approximately $110 million of urinalysis (UA) drug testing services that were medically unnecessary for patients at a sober living facility, Good Decisions Sober Living (GDSL). GDSL was paid kickbacks for providing patients to addiction treatment facilities in the West Palm Beach area, in violation of Florida state law.”

Provider groups scramble to convince lawmakers, CMMI to continue Direct Contracting mode: “The major efforts by several provider groups come in response to concerns from progressive lawmakers in Congress wanting to get rid of the model due to concerns it could fuel privatization of Medicare. Providers say such concerns are unfounded, and the model is needed to shift healthcare from fee-for-service to value.”

About hospitals and healthcare systems

 Evaluation of Unreimbursed Medicaid Costs Among Nonprofit and For-Profit US Hospitals: “In this economic evaluation, nonprofit and for-profit hospitals had similar unreimbursed Medicaid costs as a share of expenses. In half of the 45 states in which both nonprofit and for-profit hospitals operate, nonprofit hospitals had a lower weighted mean unreimbursed Medicaid cost to expense ratio than for-profit hospitals—but only nonprofit hospitals receive a sizeable tax subsidy. Thus, our results suggest that the largest component of community benefit supposedly provided by nonprofit hospitals (ie, unreimbursed Medicaid costs, net of supplemental payments) is poorly aligned with the (effectively automatic) tax subsidy that these institutions receive. Prior research suggested similar results for the provision of charity care by nonprofit vs for-profit hospitals.” 

CMS claws back Medicare payments from hospitals that own nursing schools: “For nearly a decade, the federal government has overpaid hospitals that own nursing schools an estimated $310 million, and now the Centers for Medicare and Medicaid Services want that money back. CMS posted a notice online in late 2020 stating that due to an agency error, nursing schools were overpaid by Medicare from 2008 through 2018 and needed to return that money. For many of the providers, that money will come due this summer unless a congressional effort to forgive the debts is successful.”

Nonprofit Hospital CEO Compensation: How Much Is Enough?: “Within this set of more than 1,000 nonprofit hospitals, we found that hospital executives on average made eight times the wages of workers without advanced degrees in 2018. However, this ratio varied widely. Some hospital CEOs were paid at twice the rate of other workers, while the highest paid received 60 times the hourly pay of general workers.”

About pharma

Robert Califf confirmed to lead FDA for second time: “The US Senate on Tuesday voted 50 to 46 in favour of confirming President Joe Biden nominee Robert Califf as commissioner of the FDA, a position he previously held under the Obama administration. The cardiologist will replace acting Commissioner Janet Woodcock, who stepped into the role from her position as long-time director of the FDA's Center for Drug Evaluation and Research (CDER), when Biden took office in January 2021.”

A Woman Is Cured of H.I.V. Using a Novel Treatment: “The woman, who also had leukemia, received cord blood to treat her cancer. It came from a partially matched donor, instead of the typical practice of finding a bone marrow donor of similar race and ethnicity to the patient’s. She also received blood from a close relative to give her body temporary immune defenses while the transplant took.”

FTC to vote on pharmacy benefit manager competition probe: “The Federal Trade Commission will vote Feb. 17 whether to investigate the anticompetitive impacts of pharmacy benefit managers on independent pharmacies.”

The top 10 M&A targets in biotech for 2022: FYI

 GSK becomes 13th drugmaker to restrict 340B discounts to safety net hospitals: “GlaxoSmithKline will limit 340B drug discounts for safety net hospitals' contract pharmacies, the drugmaker said in a Feb. 14 letter to hospitals. 
Effective April 1, GSK will provide 340B discounts only to locations registered as a 340B covered entity or child site location affiliated with that covered entity.”

Wearables play an increasingly pivotal role in clinical trials: “Wearable device sales are increasing worldwide. The global wearable devices market is expected to reach $62.82 billion by 2025. With wearables, patients, physicians and clinical trialists can collect data without the need for frequent office or health centre visits. FirstWord interviewed four experts in wearable technology and drug development about the use of wearables in clinical trials.
According to ClinicalTrials.gov, there have been approximately 1400 trials conducted using wearable devices. Through wearables, clinical trial researchers have captured and analysed information on various biometric data points such as heart rate, respiratory rate, blood oxygen saturation, body temperature, sleep pattern, glucose monitoring, haptics, ultraviolet tracking, pressure sensors, sweat analysis and electro-stimulation. This information can be used alone or combined with other information like patient-reported outcomes, hospitalisation rates and physical activity.
The experts said wearables are beneficial for clinical trials because they reduce the burden of data collection – automatically collating data and sending it back to pharma companies or clinical research organisations for analysis – and generate reliable, accurate information. In addition, wearables provide objective, high-frequency data from patients daily, rather than subjective data gathered from patient surveys or site visits.”

"Amazing" Nanoparticles from Maize: A Potent and Economical Anti-Cancer Therapeutic: Fascinating new nano technology: “Researchers from Tokyo University of Science have recently developed novel corn-derived bionanoparticles for targeting cancer cells directly, via an immune mechanism. The results are encouraging, and the technique has demonstrated efficacy in treating tumor-bearing laboratory mice. Moreover, no serious adverse effects have been reported in mice so far.”

About the public’s health

Why Health Affairs can't promote its latest issue: Health Affairs' entire February issue is devoted to the topic of racism and health, but Google and Twitter are blocking its paid media ads to promote the content, flagging racism as ‘sensitive content…’
The two platforms' automated systems flagged the term "racism" as sensitive content and withheld approval for the paid ads, effectively placing them in digital limbo.”

Endo Opioid Saga 'Like A John Grisham Movie,' Judge Says: “A Tennessee judge who found Endo Pharmaceuticals liable by default for opioid abuse in the state told Law360 on Monday that his extraordinary ruling stemmed from "the worst case of document hiding" he has ever encountered, likening the situation to the plot of a Hollywood legal thriller. In a Monday afternoon interview, Circuit Court Judge Jonathan Lee Young outlined the basis for his default judgment in favor of various Tennessee counties, which have alleged in a sweeping lawsuit that Endo "knowingly participates in the illegal drug market for opioids" through its past sales and marketing of prescription narcotics.”

About healthcare IT

 US warns organizations to brace for potential Russian cyberattacks: “The Cybersecurity and Infrastructure Security Agency issued a recommendation that all U.S. organizations should increase cybersecurity to shield up against potential threats from Russia.
The CISA warning, posted Feb. 14, came after the State Department advisory that urged Americans to leave Ukraine because of increased threats by the Russian military.”

South Shore Hospital breach leaves 116,000 patients' data vulnerable: “Chicago-based South Shore Hospital notified current and former patients about a cybersecurity incident that left 115,670 patients' protected information vulnerable…
The investigation found the attacker gained access to files that contained patients' and employees' first and last names, addresses, dates of birth, Social Security numbers, financial information, health insurance information, medical information, diagnoses, health insurance policy numbers, and Medicare and Medicaid information.”

Doximity brings in record profit in Q3, snaps up Amion to add physician scheduling to its platform: “Doximity, a digital platform for medical professionals, brought in $98 million in revenue in the third quarter, a 67% jump from a year ago. The health tech company also boasted a record profit of $56 million during the quarter, up from $17.2 million just one year ago. 
Doximity, which went public in June, operates like a LinkedIn for doctors and provides a digital platform for U.S. medical professionals, including telehealth and scheduling tools. The company has over 1.8 million medical professional members as of March 31, 2021, and claims to have more than 80% of doctors on its network.”

About healthcare personnel

 As state medical boards try to stamp out COVID misinformation, some in GOP push back: “Although doctors have leeway to decide which treatments to provide, the medical boards that oversee them have broad authority over licensing and discipline for misconduct. Often, doctors are investigated for violating guidelines on prescribing high-powered drugs. But physicians are sometimes punished for other types of ‘unprofessional conduct.’”
The article explains the situation in Tennessee as an example. 

Today's News and Commentary

About Covid-19

Pfizer, BioNTech delay FDA request to expand COVID-19 jab in young children: “Pfizer and BioNTech said Friday they are delaying their request for the FDA to authorise their COVID-19 vaccine Comirnaty for children under 5, as they await more data on the effectiveness of a third dose. An FDA advisory panel set to discuss the filing on February 15 has also been postponed. ‘The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion,’ the companies said.”

Booster effectiveness wanes after 4 months, but showed sturdy protection against hospitalization, CDC study shows: “Booster shots of the Pfizer-BioNTech and Moderna vaccines lose substantial effectiveness after about four months — but still provided significant protection in keeping people out of the hospital during the omicron surge, according to a study published Friday by the Centers for Disease Control and Prevention.
Researchers found the booster shots remained highly effective against moderate and severe covid-19 for about two months after a third dose. But their effectiveness declined substantially after four months, suggesting the need for additional boosters, the study said.”

 Association of Primary Care Physicians Per Capita With COVID-19 Vaccination Rates Among US Counties: “In this cross-sectional study, we found that the number of PCPs per 100 000 population was independently associated with higher COVID-19 vaccination rates in the US. Our findings suggest that PCPs play a critical role in ensuring vaccine acceptance, especially in resource-limited and vaccine-hesitant regions, potentially through counseling and building local community trust and partnerships before they had access to vaccines.”

What are taxpayers spending for those ‘free’ COVID tests? The government won’t say: “How much is the government paying for each test? And what were the terms of the agreements? The government won’t yet say, even though, by law, this information should be available.”

Placental Tissue Destruction and Insufficiency from COVID-19 Causes Stillbirth and Neonatal Death from Hypoxic-Ischemic Injury: A Study of 68 Cases with SARS-CoV-2 Placentitis from 12 Countries: “The pathology abnormalities composing SARS-CoV-2 placentitis cause widespread and severe placental destruction resulting in placental malperfusion and insufficiency. In these cases, intrauterine and perinatal death likely results directly from placental insufficiency and fetal hypoxic-ischemic injury. There was no evidence that SARS-CoV-2 involvement of the fetus had a role in causing these deaths.”
In a related article:  Association of BNT162b2 COVID-19 Vaccination [Pfizer-BioNTech]During Pregnancy With Neonatal and Early Infant Outcomes: “Maternal BNT162b2 vaccination in pregnancy was not associated with detrimental outcomes to the offspring.”

NYC set to fire nearly 3,000 unvaccinated employees: “The city requires its workforce of 370,000 — teachers, police, firefighters, office staff and others — to get at least one dose of the coronavirus vaccine by Friday. Nearly 95 percent have received at least one dose…”

New Report Finds 82% of Patients Still Experience Medication Delays, Despite Healthcare Industry Advancements:New data…[from] CoverMyMeds found 82% of patients experienced medication delays in the last year due to COVID-19 restrictions, insurance processes, communication challenges and prescription cost. Of patients who experienced medication delays, 85% had to make financial sacrifices to afford their prescriptions…
In addition to medication delays, many patients also postponed medical visits in the past year. According to the 2022 Medication Access Report, 84% of patients delayed or skipped in-person healthcare visits, mostly due to COVID-19 fears or a scarcity of appointments, contributing to an estimated 500 million missed diagnostic visits and more than 15 million fewer new prescriptions.”

How much 7 drugmakers are earning from COVID-19 treatments: FYI
And in a related article: Lilly back in COVID-19 antibody game with $720 million deal with U.S. for omicron-busting hopeful: “The U.S. has agreed to a $720 million deal for bebtelovimab, the company announced on Thursday. Lilly has submitted its request for an emergency use authorization, and contingent upon an FDA nod, the company will supply 600,000 courses of the treatment for high-risk patients with mild-to-moderate COVID-19.”

About health insurance

 2021 AMA prior authorization (PA) physician survey: Among other findings, this AMA member survey found the following:
—”24% of physicians report that PA has led to a patient’s hospitalization.
—18% of physicians report that PA has led to a life-threatening event or required intervention to prevent permanent impairment or damage.
—8% of physicians report that PA has led to a patient’s disability/permanent bodily damage, congenital anomaly/birth defect or death.”
Undoubtedly, insurers will push back on the necessity of PA for cost and quality reasons.

Even insured Americans lack funds for out-of-pocket medical costs, new Aflac Care Index shows Nationwide survey reveals the financial implications of medical bills not covered by insurance and identifies the 11 most at-risk states: “According to the Aflac Care Index, 24% of respondents report having no money in their savings accounts and 48% say they have $1,000 or less. Further exacerbating the situation is that 33% of insured Americans cannot go more than one week without a paycheck, while 71% cannot endure a month without pay, leading many (25%) to have to borrow money in the event of a medical emergency, almost a quarter (22%) saying they would need to find an additional job, and 6% would have to file bankruptcy. At the same time, approximately three-quarters of insured respondents underestimate their financial exposure to common medical challenges, such as heart disease (79%) and breast cancer (73%).”

Association Between Hospice Enrollment and Total Health Care Costs for Insurers and Families, 2002-2018: “In this cohort study, hospice use by community-dwelling Medicare beneficiaries was associated with significantly lower total health care costs across all payers in the last 3 days to last 3 months of life. We found no evidence of cost shifting from Medicare to families and families had significantly lower out-of-pocket health care costs in the last 3 days to last month of life when patients enrolled with hospice.”

Signify Health Buying Caravan Health for $250 Million: “The transaction also includes contingent additional payments of up to $50 million based on the future performance of Caravan, which will join Signify Health in supporting a wide spectrum of advanced payment models.
With the acquisition, Signify adds Caravan's more than 200 health systems and 100 Federally Qualified Health Centers with more than 10,000 primary care providers that collectively manage over 500,000 patients.
The combination supports Signify Health's diversification strategy to offer a comprehensive platform and solution set supporting and integrating episodes and total cost of care risk arrangements across Medicare programs.”

Molina Healthcare revenue up 43% to $27.8B: 6 things to know: “The payer reported $659 million in net income, down 2 percent over 2020's year-end income. The medical care ratio for 2021 was 88.3 percent, up 1.7 percentage points from 2020's. Molina Healthcare set a $29.5 billion revenue outlook for 2022, representing an increase of 6 percent.”

South Florida Medical Clinic Owner Sentenced to 10 Years in Prison for Orchestrating $42 Million Health Care Fraud Conspiracy: “Yesterday, a federal district judge in Miami sentenced Bradley Jason Kantor, 49, of Key Largo, Florida, to 10 years in federal prison for submitting approximately $42 million in fraudulent health care claims to United Healthcare.
From April 2013 to March 2017, Kantor owned and operated Mobile Diagnostic Imaging, Inc. (“MDI”), a medical clinic in Davie, Florida that purported to provide antigen therapy and other allergen immunotherapy services, such as allergy testing and allergy shots, to commercial insurance beneficiaries.  Kantor offered and paid kickbacks to co-conspirators to induce them to refer beneficiaries to MDI, so that MDI could bill commercial insurers for services that it never provided.”

Ten Indicted for Healthcare Kickbacks: “Ten people, including two medical doctors, have been indicted in a $300 million healthcare fraud, announced U.S. Attorney for the Northern District of Texas Chad E. Meacham…
According to the indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs LLC, allegedly paid kickbacks to induce medical professionals to order medically unnecessary lab tests, which they then billed to Medicare and other federal healthcare programs.
The medical professionals -- including internal medicine specialist Eduardo Canova, family medicine practitioner Jose Maldonado, and nurse practitioner Keith Wichinski – allegedly accepted the bribes and ordered millions of dollars’ worth of tests.
Meanwhile, Unified, Spectrum, and Reliable disguised the kickbacks as legitimate business transactions, including as medical advisor agreement payments, salary offsets, lease payments, and marketing commissions.”


About hospitals and healthcare systems

 Prospect to sell Crozer to ChristianaCare: “Newark, Del.-based ChristianaCare plans to acquire Springfield, Pa.-based Crozer Health from Los Angeles-based Prospect Medical Holdings after signing a letter of intent.
Through the deal, ChristianaCare would also take over Crozer's related businesses, real estate assets, Crozer Health Medical Group, associated assets, ambulatory centers, medical office buildings, physician clinics and ancillary outpatient services, according to a Feb. 11 news release…
Crozer, which has about 4,000 employees, will return to a nonprofit organization once the deal is finalized.”

About pharma

Pharma R&D Pipeline and New Product Launches Reach Record Levels in 2021 According to New IQVIA Institute for Human Data Science Report: Highlights of the study:

  • “Clinical trial activity saw sustained growth through the pandemic with 5,500 new planned clinical trial starts in 2021, a 14% increase over 2020

  • The total number of products in active development exceeded 6,000, up 68% from 2016

  • A record 84 novel active substances were initially launched globally in 2021, double the number of five years ago

  • The composite R&D success rate across all therapy areas declined to 5% in 2021, due to the more challenging clinical development programs being deployed

  • Emerging biopharma companies are responsible for a record 65% of the molecules in the R&D pipeline — up from less than 50% in 2016”

 FDA panel gives thumbs down to Lilly, Innovent's China-developed cancer drug: A “follow-on” to yesterday’s article about FDA’s caution approach to Chinese studies:
”An FDA advisory panel voted 14 to 1 on Thursday that Eli Lilly and Innovent Biologics should conduct more trials of their anti-PD-1 antibody sintilimab in order to win US approval. The vote comes days after FDA staff scientists concluded that a Chinese study used to support the drug's administration in first-line non-small-cell lung cancer (NSCLC) had several shortcomings and its results were not applicable to US patients.”

Researchers restore function in a gene that can suppress liver cancer and enhance immunotherapy: “A team of researchers from Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH) has reprogrammed the tumor microenvironment of liver cancer by using mRNA nanoparticles. This technology, similar to the one used in COVID-19 vaccines, restored the function of the p53 master regulator gene, a tumor suppressor mutated in not just liver but also other types of cancer. When used in combination with immune checkpoint blockade (ICB), the p53 mRNA nanoparticle approach not only induced suppression of tumor growth but also significantly increased antitumor immune responses in hepatocellular carcinoma (HCC) laboratory models.”

About the public’s health

 CMS expanding coverage for low-dose CT lung cancer screening: “CMS’ final decision will expand eligibility for Medicare beneficiaries to receive such lifesaving screenings by dropping the starting age from 55 down to 50 years old. The agency will also reduce the tobacco smoking history threshold from at least 30 packs per year down to at least 20, according to an announcement.”

The 10 States With the Longest Life Expectancy: At the top is Hawaii. “Nine of the 10 states with the lowest life expectancy in 2019 were located in the South.”  For a full report, see this CDC website.

CDC proposes softer guidance on opioid prescriptions: The current, 6 year old, recommendations have fixed dose limits. The proposed changes call for more individualized doses- the minimum needed to control pain.
And in a related article: Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court: “Doctors have wide latitude to prescribe drugs, including potentially dangerous ones, but even they face limits. The question is, what threshold do physicians have to cross — and what sort of intent do they need to have — for their prescribing to be considered a crime?
It’s an issue headed to the Supreme Court next month, in a case concerning two physicians who were convicted of unlawfully dispensing opioid painkillers.”

Evaluation of Statewide Restrictions on Flavored e-Cigarette Sales in the US From 2014 to 2020: “Were statewide restrictions on flavored e-cigarette sales in Massachusetts, New York, Rhode Island, and Washington associated with a reduction in total e-cigarette unit sales from 2014 to 2020?
Findings  In this cross-sectional study, a difference-in-differences analysis of e-cigarette retail data showed that statewide restrictions on non–tobacco-flavored e-cigarette sales were associated with reductions of 25.01% to 31.26% in total e-cigarette unit sales compared with total sales in states without restrictions. The reductions were attributable mostly to decreases in non–tobacco-flavored e-cigarette sales.”

Uterine Cancer Mortality Now Neck and Neck With Ovarian Cancer: “Uterine cancer has pulled even with ovarian cancer as a leading cause of gynecologic cancer mortality, accompanied by an ‘alarming’ racial disparity, a large epidemiologic study showed.
Annual uterine cancer mortality declined from 4.3 to 4.0 per 100,000 women from 1990 to 1997, then increased to 5.1/100,000 in 2019, representing a 1.7% annual increase. In contrast, ovarian cancer mortality decreased from 9.3/100,000 in 1990 to 6.0/100,000 in 2019 (-2.7%/year from 2010-2019).”

About healthcare IT

 UnitedHealth rolls out new virtual options for dental care: “UnitedHealthcare Dental is launching multiple digital resources aimed at making it more convenient for members to manage their oral health, the insurer announced this week.
UHC will enhance its 24/7 virtual dental benefit to provide two free virtual visits with a dentist per year, an upgrade that will be made available to fully insured employer plans. During these visits, members can seek advice telephonically or via video about acute oral health needs, as well as find guidance on where to access care in-person if needed.”

Outpatient telehealth use soared early in the COVID-19 pandemic but has since receded: “Prior to the onset of the pandemic in the United States, telehealth use was a negligible share (rounding to 0%) of outpatient visits. Many enrollees have had increased access to telehealth services over the last two years. During this period, telehealth use soared from less than 1% of outpatient visits before the pandemic to 13% of outpatient visits in the first 6 months of the COVID-19 pandemic. This rate declined to 11% during the next 6-month period, and then to 8% a year into the pandemic (March-August, 2021).”

About healthcare personnel

 Medicine’s Worst-Paying Specialty Is Luring Billions From Wall Street : “U.S. companies focused on primary care raised about $16 billion from investors in 2021, according to unpublished research by Harvard scholars. That’s more than four times the amount invested in 2020 and up from just $15 million reported in 2010, they said.”
The entire article is well-worth reading for an explanation of how primary care is essential for delivery of risk-based, value-driven care models.

If 1 in 5 healthcare workers have quit, where have they gone?: “When looking at the national numbers, based on Bureau of Labor Statistics data, the overall healthcare workforce is only down 2.7 percent from February 2020…
That number is mostly in nursing homes, she added. When looking at just hospitals, the workforce is down 1.8 percent from February 2020. 
This means many people who quit their jobs are being hired in other healthcare jobs. Or as some leave, others are being hired…”

Today's News and Commentary

Luc Montagnier, Nobel-winning virologist who co-discovered HIV, dies at 89: “The lab of Dr. Montagnier… discovered HIV, the drug-resistant virus that was later found to cause AIDS…Dr. Montagnier and his team fought for recognition from the scientific community, which ignored and sometimes scorned their early research.
Ultimately, the work done by Dr. Montagnier and his colleagues — including Françoise Barré-Sinoussi who detected telltale viral activity in the original sample — paved the way for an HIV blood test, spurred the development of AIDS drugs and therapies, and earned the two Pasteur scientists a share of the Nobel Prize in physiology or medicine in 2008.”

About Covid-19

COVID cases surpass 400 million as Omicron grips world: “It took over a month for COVID cases to reach 400 million from 300 million, compared to five months for the cases to reach 300 million from 200 million, according to a Reuters tally. The pandemic has killed over 6 million people worldwide.”

 Covid-19 hospitalizations drop below 100,000 in the US, but heavy burden persists : “For the first time in more than a month, there are fewer than 100,000 hospital beds in use for patients with Covid-19 nationwide, according to data from the US Department of Health and Human Services.
That's a 38% drop from a few weeks ago, when Covid-19 hospitalizations reached a peak of more than 160,000 beds in use at one time.”

U.S. appeals court will not block order barring Biden federal staff vaccine mandate: “A U.S. appeals court panel on Wednesday declined to block a lower court ruling that President Joe Biden could not require federal employees to be vaccinated against the coronavirus.
By a 2-1 vote, the 5th Circuit Court of Appeals declined to stay the lower-court injunction. Judge Stephen A. Higginson dissented noting a dozen district courts rejected requests to block the vaccine rule while a single district judge issued an injunction.”

HHS awards another $66.5M for community-based vaccination programs: “The Department of Health and Human Services has released another $66.5 million toward community-based vaccination outreach programs across 38 states and the District of Columbia...
These awards are the fourth wave of American Rescue Plan funding and is intended to develop and support a community-based workforce able to reach those living in vulnerable and medically underserved communities.
Although initially announced as a $250 million investment, the latest round of awards bring the administration’s total to nearly $390 million.”

Researchers confirm newly developed inhaled vaccine delivers broad protection against SARS-CoV-2, variants of concern: “Scientists at McMaster University who have developed an inhaled form of COVID vaccine have confirmed it can provide broad, long-lasting protection against the original strain of SARS-CoV-2 and variants of concern…
Because inhaled vaccines target the lungs and upper airways where respiratory viruses first enter the body, they are far more effective at inducing a protective immune response, the researchers report.
The reported preclinical study, which was conducted on animal models, has provided the critical proof of concept to enable a Phase 1 clinical trial that is currently under way to evaluate inhaled aerosol vaccines in healthy adults who had already received two doses of a COVID mRNA vaccine.”

Hospital-acquired COVID-19 infections were rare through fall 2021: “Hospital-developed COVID-19 cases represent about 1.8% of COVID-19 hospitalizations and were potentially on the decline by the tail end of the pandemic’s delta wave, according to a patient data analysis conducted by electronic health record vendor Epic…
These hospital-developed COVID-19 infections—defined as hospitalized patients who tested negative on the day of or day after admission but then tested positive six or more days later—reached its peak on the week of Dec. 6, 2020, with 172 such cases.”

Oklahoma won't discipline physicians prescribing unproven COVID-19 treatments: “Physicians in Oklahoma are not prohibited from prescribing unapproved treatments such as ivermectin and hydroxychloroquine for the off-label purpose of treating COVID-19 patients, the state attorney general's office said Feb. 8. 
The office of Oklahoma Attorney General John O'Connor said it ‘finds no legal basis for a state medical licensure board to discipline a licensed physician’ for using their judgment and prescribing FDA-approved drugs for the off-label — when a drug approved for a specific disease or condition is prescribed for something else — purpose of treating COVID-19.”

Conflicting reports raise questions about whether any monoclonals work against Omicron’s sister variant: “A pair of conflicting reports released this week raised questions about whether the Covid-19 monoclonal antibody sotrovimab — the one such treatment that has continued to work against the Omicron variant — maintains its power against a sister form of the virus, BA.2.”
Read the article for more details.

About health insurance

 Provider groups push court to press pause on controversial surprise billing rule: “The American Medical Association, American Hospital Association and several other provider groups wrote in a legal filing Tuesday that a federal judge needs to quickly issue a stay of the final rule that governs the arbitration process for handling out-of-network charges. The groups pushed back over the arguments that the administration delivered last month.”

Former NFL Player Sentenced to Prison for Nationwide Health Care Fraud Scheme: “According to court documents, Robert McCune, 42, of Riverdale, Georgia, defrauded the Gene Upshaw NFL Player Health Reimbursement Account Plan (the Plan). The Plan was established pursuant to the NFL’s 2006 collective bargaining agreement. It provided former players, their spouses and their dependents, up to a maximum of $350,000 per player tax-free reimbursement of out-of-pocket medical care expenses that were not covered by insurance.
Court documents show that McCune submitted false and fraudulent claims to the Plan on his own behalf and on behalf of dozens of other former NFL players. Between June 5, 2017, and April 12, 2018, he submitted 68 claims for 51 other players. The claims typically sought reimbursement of $40,000 or more for expensive medical equipment such as hyperbaric oxygen chambers, ultrasound machines and electromagnetic therapy devices. None of the medical equipment described in the claims was ever purchased or received. In total, McCune and his co-conspirators submitted approximately $2.9 million in fraudulent claims to the Plan.”

'Big 6' payers ranked by 2021 revenue: “Here are the top 6 payers based on year-end revenue:

1. UnitedHealthcare: $223 billion

2. Cigna: $174.1 billion

3. Anthem: $137 billion* 

4. Centene: $126 billion

5. Humana: $83.1 billion

6. Aetna: $82.2 billion”

About hospitals and healthcare systems

 Semi-Annual Hospital Price Transparency Compliance Report: “Of the 1,000 total hospitals reviewed, we found:
—Only 14.3% were complying with the transparency rule.
—Only 37.9% of the hospitals posted a sufficient amount of negotiated rates, but over half werenot compliant in other criteria of the rule, such as rates by each insurer and named plan.
—Only 0.5% of hospitals owned by the three largest hospital systems in the country – HCAHealthcare, CommonSpirit Health, and Ascension – were in compliance.”

Three New Best Practices in the 2022-2023 Targeted Medication Safety Best Practices for Hospitals:
“New Best Practice 17: Safeguard against errors with oxytocin use…
New Best Practice 18: Maximize the use of barcode verification prior to medication and vaccine administration by expanding use beyond inpatient care areas…
New Best Practice 19: Layer numerous strategies throughout the medication-use process to improve safety with high-alert medications.”
Read the website for more details about these three new items.

Yale New Haven Health to acquire 2 Connecticut health systems: “Yale New Haven (Conn.) Health System agreed Feb. 10 to acquire two Connecticut health systems from Los Angeles-based Prospect Medical Holdings. 
The deal includes the Connecticut systems' related businesses, real estate assets, physician clinic operations and outpatient services, according to a news release from Yale New Haven Health.”

Ascension, Labcorp partnership brings expanded testing to hospital labs: “According to a Feb. 9 news release shared with Becker's, Labcorp will manage Ascension's hospital-based labs in 10 states: Alabama, Florida, Kansas, Maryland, Michigan, New York, Oklahoma, Tennessee, Texas and Wisconsin…
 Labcorp and Ascension anticipate the transactions will close in the first half of 2022.”

About pharma

 Biotechs face cash crunch after stock market ‘bloodbath’ : “Biotech groups, most of them lossmaking, raised a record $32.7bn in initial public offerings over the past two years, according to data from Refinitiv. But 83 per cent of recently listed US biotech and pharma stocks are now trading below their IPO price. Biotech groups that listed in 2021 are trading on average 37 per cent below their IPO price, compared with a 22 per cent fall for all newly US-listed companies. Many such companies raised money through IPOs with the expectation that they would be able to tap investors for fresh funds in subsequent share sales as their drugs progressed through the research and development cycle.”

EMA launches new centre to gather real-world health data for drug regulation: “The European Medicines Agency on Wednesday announced the set-up of a coordination centre that will be key to its efforts to incorporate real-world evidence (RWE) into the regulation of medicines in Europe. It is working with Erasmus University Medical Center Rotterdam to establish the centre, which will form part of the broader Data Analysis and Real World Interrogation Network (DARWIN EU) project, to supply RWE requested by the EMA itself and EU member states' regulators.
DARWIN EU will connect Europe's drug regulatory network to the so-called European Health Data Space (EHDS), an initiative intended to improve the exchange and access to different types of health data. The objective is to assemble a network of real-world health data sources that will provide ‘valid and trustworthy’ RWE from across Europe on things like diseases, patient populations, and the uses and performance of medicines.”

Were Prescription Drug Prices the Fastest-Growing Commodity or Service in 2021?: “Key takeaways:  —Prescription medication prices are no longer the fastest-growing commodity or service. In 2021, the cost of car rentals, tobacco, beef, and moving expenses all outpaced the cost of prescription drugs.
—However, prescription drug costs have still increased 2.5% since the start of the pandemic. 
—Prescription drug prices have also historically grown faster than the rate of inflation. Since 2014, drug prices have increased 35%, while the cost of all items and services has increased 19%.” 

About the public’s health

 Single accountable figure to lead new health and care ‘place boards’ : As our country looks for better organizational models to deliver healthcare, this British proposal calls for a single local head to coordinate both health and social welfare services.
”A white paper, published this afternoon, endorses a model featuring an integrated health and social care board at a 'place' level - more localised than integrated care systems (ICSs). It is at this place board level that budgets would be pooled or aligned, and the single accountable leader would operate.
The white paper, Health and Social Care Integration: joining up care for people, places and populations, says all places with an ICS will be expected to adopt the government’s ‘place-board’ governance model or an equivalent which achieves the same aims, by spring 2023.”

About healthcare IT

 CY2022 Telehealth Update Medicare Physician Fee Schedule: From CMS, a short explanation of telehealth billing; it goes into effect April 1, 2022. 

5 Healthcare Trends for 2022: Some highlights:
72% of U.S. adults read online patient ratings and reviews when considering the decision of a healthcare facility or physician. 

50% of U.S. adults read 10+ reviews, and 23% read 20 or more when selecting care. 

55% of Millennials have selected one physician or location over another based on online reviews. 

72% of healthcare consumers want the provider they choose to be rated 4 out of 5 stars or higher. 

65% of respondents say it’s important for providers to respond to reviews. 

Google is also the #1 review site used by healthcare consumers. 

Brand loyalty is declining everywhere…Among Millennials, the largest population segment in the United States, only 19% say they would choose a physician based on their connection to a brand.”

Today's News and Commentary

About Covid-19

 Updated Pediatric COVID-19 Vaccination Operational Planning Guide — Information for the COVID-19 Vaccine for Children 6 Months–4 Years Old: From the CDC: “This operational planning guide includes details about the anticipated Pfizer-BioNTech product and may be updated as other manufacturers submit applications for FDA review…
 There are approximately 18 million children ages 6 months through 4 years in the United States. The U.S. government has procured enough vaccine to support vaccination of this population, pending FDA EUA and CDC recommendation. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on February 15, 2022. ACIP is anticipated to meet within several days of VRBPAC; the meeting will be posted here once scheduled: https://www.cdc.gov/vaccines/acip/index.html.

U.S. CDC stands by K-12 school masking guidance as states relax rules –Walensky: “With COVID-19 cases still high nationwide, "now is not the moment" to drop mask mandates in schools and other public places, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky told Reuters on Tuesday.”

J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need: “A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory…
[T]he American company… late last year quietly shut down the only plant making usable batches of the vaccine, according to people familiar with the decision.
The facility, in the Dutch city of Leiden, has instead been making an experimental but potentially more profitable vaccine to protect against an unrelated virus.
The halt is temporary — the Leiden plant is expected to start churning out the Covid vaccine again after a pause of a few months — and it is not clear whether it has had an impact on vaccine supplies yet, thanks to stockpiles.”

The CDC’s do-not-travel list now encompasses more than half the world’s destinations: “The Centers for Disease Control and Prevention has moved seven more countries to its highest-risk category for travel — a list that has grown to include 134 destinations, with many added since the World Health Organization declared omicron a “variant of concern” on Nov. 26.
The CDC on Monday gave the Democratic Republic of Congo, Oman, Libya, Japan, Israel, Cuba and Armenia a “Level 4″ warning, which means it is recommending that Americans avoid traveling there, even if vaccinated.”

HHS is running out of money to pay doctors to treat uninsured COVID-19 patients: “Federal program which reimburses healthcare workers who care for uninsured COVID-19 patients, is expected to run out of money by spring or summer.
The Provider Assistance Fund has paid more than $17 billion to treatment, testing and vaccination providers for the uninsured throughout the pandemic. The Department of Health and Human Services program has become a lifeline for health care providers, especially in states like Texas and Florida, where the percentage of people without health insurance is high.”
Relief funds are not just paying doctors. In a related story: Travel Nurses Make Twice as Much as They Did Pre-Covid-19: “Hospitals and lawmakers are pressing the Biden administration to review federal pandemic-relief programs that they say have distorted pay rates for travel nurses.”

About health insurance

 Anthem rolling out virtual primary care to plans in 11 states: “The expansion will roll out the offering to fully insured plans and select large group administrative services clients in Colorado, Connecticut, Georgia, Indiana, Kentucky, Missouri, Nevada, New York, Ohio, Virginia and Wisconsin, the company said. Eligible members can access a virtual care team that will conduct an initial health check-in and then craft a personalized care plan.
The insurer is expecting a significant number of its administrative services clients to adopt the platform over the course of this year.”

Obamacare Insurers Use Tech, Tenacity to Keep Customers on Board: “Every year, roughly 10% of marketplace plan members have their coverage terminated for nonpayment or other reasons. To maintain the new bumper crop of enrollees, some insurers will use artificial intelligence, advanced analytics, and machine learning to identify members most likely to let their policies lapse. Eventually, all carriers will target their at-risk enrollees with phone calls, emails, texts, and letters.”

Highmark Makes a $245M Impact in the Fight Against Healthcare Fraud, Waste and Abuse in 2021: “Highmark's Financial Investigations and Provider Review (FIPR) department generated more than $245 million in savings related to fraud, waste and abuse in 2021, and has made a cumulative financial impact of nearly $1 billion in such activity since 2017…
FIPR's 2021 savings included approximately $184 million in activity related to billing/coding errors, fraud, waste and abuse in Pennsylvania, $25 million in West Virginia, and $23 million in Delaware.”

Bay City Vascular Surgeon Pleads Guilty in Connection with Defrauding Medicare, Medicaid, And Blue Cross Blue Shield Of $19.5 Million: “According to the plea agreement, [Dr. Vasso] Godiali began knowingly defrauding the three medical insurers in approximately 2009 and did so by causing the submission of false billing to all three insurers. As evidenced in the plea agreement, Godiali’s false and fraudulent billing includes admissions related to claims for the placement of stents in dialysis patients and for the treatment of arterial blood clots. Godiali admitted that he billed for the placement of multiple stents in the same vessel, and prepared medical records purporting to document the medical necessity justifying that billing. In fact, Godiali did not place those stents, and he admitted to billing the insurers for services never rendered while preparing materially inaccurate medical records to justify the fraudulent billing.”

Health Connector offering health insurance sign up on Mass income tax form: Interesting idea: “The Massachusetts Health Connector’s new Simple Sign-up program will let uninsured residents check a box on their state tax forms and start the process of getting health insurance. This will allow the Department of Revenue (DOR) to forward the tax filer’s information to the Health Connector, which will then create and send information to the tax filer to help them obtain the best health plan.”

About hospitals and healthcare systems

 Health Care Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars: “The federal government has penalized 764 hospitals — including more than three dozen it simultaneously rates as among the best in the country — for having the highest numbers of patient infections and potentially avoidable complications….
This year’s list of penalized hospitals includes Cedars-Sinai Medical Center in Los Angeles; Northwestern Memorial Hospital in Chicago; a Cleveland Clinic hospital in Avon, Ohio; a Mayo Clinic hospital in Red Wing, Minnesota; and a Mayo hospital in Phoenix. Paradoxically, all those hospitals have five stars, the best rating, on Medicare’s Care Compare website.”

100 top critical access hospitals, by state: FYI: “The Chartis Center for Rural Health recently released its annual list of the top 100 critical access hospitals in the U.S.”

About pharma

 Amgen reports revenue bump in Q4, but Enbrel slides: “The company said revenues in the last three months of 2021 were driven by an increased contribution from the collaboration it has to help make Eli Lilly's COVID-19 antibody treatment. It did not say how much it received from the arrangement in the period, but Amgen recorded $575 million listed under ‘other revenue’ in its quarterly report.
Meanwhile, product sales were down 1% during the period because while unit volumes grew, Amgen said this gain was ‘more than offset by lower net selling price and lower inventory levels,’ which notably affected Enbrel. Still, the company did see double-digit volume growth on some key products such as Prolia, Mvasi, Repatha and Evenity.”

GSK's Q4 results boosted by sales of COVID-19 treatment: “GlaxoSmithKline noted that fourth-quarter sales of prescription drugs were mainly driven by new and specialty products. Sales of Xevudy, a monoclonal antibody for the treatment of COVID-19, reached £828 million ($1.1 billion), topping estimates of £774 million ($1 billion), contributing approximately 20 percentage points to pharmaceuticals growth.”

FDA wary of drugs developed in China: “The FDA is concerned about the quality of studies evaluating cancer drugs and other new medicines developed in China, The Wall Street Journal reported Feb. 9…
Drug industry analysts said the FDA's reservations may mean Chinese biotech companies and their Western partners will need to lead additional U.S.-based tests for their proposed drugs.”

Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial: “Regular daily intake of 4 g acetaminophen increases systolic BP in individuals with hypertension by ≈5 mm Hg when compared with placebo; this increases cardiovascular risk and calls into question the safety of regular acetaminophen use in this situation.”
If confirmed, this finding could indicate a major problem in treating these patients, since NSAID drugs have the same effect.

About the public’s health

 Appeals court rules in Biden’s favor on abortion referrals: “Federally funded family planning clinics can continue to make abortion referrals for now, a federal court ruled Tuesday, in a setback for a dozen Republican attorneys general who have sued to restore a Trump-era ban on the practice.
The 6th U.S. Circuit Court of Appeals in Cincinnati denied a request by the 12 states to pause rules for the federal government’s family planning program while their case is heard. The states were eager to stop implementation before the next round of federal grants starts rolling out in March.”

Prevalence and Income-Related Disparities in Thirdhand Smoke Exposure to Children: “Nicotine was detected on the hands of 189 of 193 children (97.9%) reportedly exposed…and on the hands of 296 of 311 children (95.2%) reportedly protected from exposure to tobacco products…. In multivariable linear regression models, child age, family income, parent tobacco use, home smoking rules, and the number of tobacco users with whom a child had contact were significantly associated with hand nicotine…. Children aged 2 to 4 years, from low-income homes, whose parents used any tobacco products, with multiple contacts with tobacco users, and without complete smoking bans had the highest hand nicotine levels…. Children from lower-income families benefited significantly more from tobacco protections compared with children from higher-income homes…”
What is surprising is the unexpectedly high rate of nicotine detection in houses reported as non-smoking.

About healthcare IT

 Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides: “On August 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released a final rule requiring eligible hospitals to attest annually that they performed a safety assessment of their electronic health record (EHR) system using SAFER (Safety Assurance Factors for EHR Resilience) Guides.1 This milestone affects virtually all US hospitals, but there is no specific guidance on how hospitals should perform a self-assessment of these recommended practices. To address this gap, pragmatic guidelines were developed to provide a streamlined, stepwise approach for conducting a systematic EHR safety assessment that optimizes organizational resources, minimizes process inefficiencies, and maximizes EHR vendor involvement.”
The essence of the recommendations is in the online supplement to the article:
1  Identify the SAFER assessment team…

2  Determine which recommendations require EHR vendor action or attestation…

3  Meet synchronously and asynchronously…

4  Document and communicate implementation status…

5  Prioritize and address unmet SAFER recommendations…”

Health insurers may be using biased machine learning models. Here’s how to fix them: “In an analysis published in Health Affairs, researchers from Independence Blue Cross, the Massachusetts Institute of Technology and the University of California Berkeley identified several areas where bias can arise in machine learning tools used by health insurers and outlined recommendations for tackling those issues.”

Indicators of Compromise Associated with LockBit 2.0 Ransomware and Additional Mitigations: “A warning from HHS’s cybersecurity program: “LockBit 2.0 operates as an affiliate-based Ransomware-as-a-Service (RaaS) and employs a wide variety of tactics, techniques, and procedures, creating significant challenges for defense and mitigation. The indicators of compromise (IOCs) and malware characteristics outlined in this Report were derived from field analysis and are current as of February 2022.”

Amazon expanding healthcare service to 20 more cities, lands Silicon Labs, Whole Foods Market as customers: “The online retailer has inked deals to provide healthcare services to Silicon Labs, TrueBlue and Whole Foods Market, the company announced Tuesday. These companies join Precor, a Washington-based fitness equipment company that was acquired by Peloton, and Hilton as clients Amazon has publicly disclosed.”  

Today's News and Commentary

Biden’s top science adviser bullied and demeaned subordinates, according to White House investigation: “President Joe Biden’s top science adviser, Eric Lander, bullied and demeaned his subordinates and violated the White House’s workplace policy, an internal White House investigation recently concluded, according to interviews and an audio recording obtained by POLITICO”
The investigation led to Lander’s resignation last night..

Press Ganey Announces Plans to Acquire Forsta -- a Leader in the 2021 Gartner® Magic Quadrant™ for Voice of the Customer -- to Accelerate Innovation in the Global Healthcare Experience Industry: Press Ganey, a renowned leader in patient, member, employee and consumer experience across the healthcare ecosystem, today announced its plans to acquire Forsta, an industry-leading global provider of customer experience and market research technology. Forsta is named a Leader in the 2021 Gartner® Magic Quadrant™ for Voice of the Customer. The transaction is expected to close in the first or second calendar quarter of 2022, and is subject to regulatory approvals and other customary closing conditions.”

About Covid-19

Biden officials trying to recalculate U.S. Covid-19 hospitalizations: “A task force comprised of scientists and data specialists at the Department of Health and Human Services and the Centers for Disease Control and Prevention are working with hospitals nationwide to improve Covid-19 reporting. The group is asking hospitals to report numbers of patients who go to the facility because they have Covid-19 and separate those from individuals who go in for other reasons and test positive after being admitted…”

 Pharmacies feel stiffed on COVID pill payments: “Some pharmacies are getting paid as little as $1 to dispense the COVID antiviral pills made by Pfizer and Merck.” Dispensing fees from commercial insurers are all “lower than the federal government's dispensing fee for uninsured patients, which is $12.”
Why it matters: Most pharmacies want to offer the drugs, especially the one from Pfizer that drastically cuts the odds of hospitalization and death. But low payments could hurt Americans' ability to access the pills in some areas if pharmacies decide they can't afford to stock them.”

CMS Issues Over-the-Counter Coronavirus Testing Guidance: “CMS released guidance around the over-the-counter coronavirus testing requirement, providing greater clarity regarding what kinds of direct-to-consumer access mechanisms fall under compliance and answering questions related to testing shortages and fraud.
The guidance explained that the requirement to provide adequate access to over-the-counter coronavirus tests entails establishing an in-person method of receiving the tests and a direct-to-consumer shipping option.”

Durability of Anti-Spike Antibodies in Infants After Maternal COVID-19 Vaccination or Natural Infection: “This study found that the majority of infants born to COVID-vaccinated mothers had persistent anti-S antibodies at 6 months, compared with infants born to mothers with SARS-CoV-2 infection.” Another piece of evidence that Covid-19 vaccination can afford better protection than natural infection.”

CDC to recommend faster Covid-19 boosters for certain immunocompromised people: “The CDC has been recommending that immunocompromised people who got an mRNA vaccine get an additional booster, a fourth shot, at least five months after their third shot. It's going to revise these guidelines to encourage a booster at three months instead. This applies to people 18 and older who got the Moderna vaccine and people 12 and older who got the Pfizer/BioNTech vaccine.”

Governors in 4 states plan for end to school mask mandates: “The governors of four states announced plans Monday to lift statewide mask requirements in schools by the end of February or March, citing the rapid easing of COVID-19′s omicron surge.
The decisions in Connecticut, Delaware, New Jersey and Oregon were announced as state and local governments grapple with which virus restrictions to jettison and which ones to keep in place. The changes also come amid a growing sense that the virus is never going to go away and Americans need to find a way to coexist with it.”

About health insurance

 Centene hits $126B in 2021 revenue, up 13%: 10 things to know: Some highlights: “Centene hit the top end of its 2021 revenue outlook, landing at $126 billion largely thanks to Medicare and Medicaid growth….
The revenue growth was attributed to both Medicare and Medicaid membership growth, as well as acquiring Pantherx and Circle Health….
Revenue growth contributed to a reported $598 million in fourth quarter profits and $3 billion in year-end profit.”

About hospitals and healthcare systems

Healthgrades Announces 2022 America's Best Hospitals™: Check the website for state-by-state listings in different categories.

 States Move to Protect Hospital Patients from Heavy Medical Debt: “More states are imposing new limits on hospital billing practices, making fresh attempts to help patients avoid heavy medical debts. 
At least 10 states, including Connecticut, Maryland, New Mexico and Maine, enacted laws last year with a range of provisions affecting healthcare providers and collection agencies, including requirements for hospitals to provide financial assistance to people with low incomes or limit aggressive debt-collection practices. Other states, including Washington and Vermont, are currently considering bills to add or bolster consumer medical-billing protections.”

 Tenet sees annual profit more than double, plans to retire $700M of debt: “Dallas-based Tenet Healthcare ended 2021 with a net income from continuing operations of $915 million, more than doubling the $399 million recorded the same period one year before. 
The for-profit hospital operator said its results for the year ending Dec. 31, 2021, included a pre-tax gain of $406 million associated with the divestiture of five Miami-area hospitals, as well as stimulus funds totaling $205 million. In 2020, Tenet recorded grant income of $899 million.”

About pharma

 FDA Resumes Domestic Inspections: “The FDA resumed normal domestic inspections of device facilities yesterday, citing the declining rates of COVID-19 cases across the country.
The FDA had announced on Dec. 29 that it was temporarily suspending many of its domestic and foreign inspections due to fast-spreading SARS-CoV-2 Omicron variant. The agency said it will continue to use a variety of tools to conduct both domestic and foreign mission-critical inspections, including remote assessments.”

CVS teams with Medable to expand access to clinical trials: “CVS Health is teaming up with Medable to access and engage around clinical trials at select MinuteClinics, the healthcare giant announced Monday.
CVS Health Clinical Trial Services, a new arm at the company launched last May, will harness Medable's software platform to deliver clinical trials with a focus on accessibility and retention to enhance the effectiveness of research, according to the announcement.”

PBMs ranked by market share: CVS Caremark is No. 1: “Three companies dominate the pharmacy benefit manager market, accounting for 79 percent of all prescription claims in 2020, according to data from Health Industries Research Companies, an independent, non-partisan market research firm.”

About the public’s health

Commission on Combating Synthetic Opioid Trafficking: A fascinating bipartisan report sponsored by a number of governmental agencies. The Commission notes that illegal use has moved from prescription opioids, to heroin, to synthetics, especially fentanyl. The latter is easier and cheaper to produce than the other opioids.
To put the problem in perspective: “Higher potency allows cartels [mostly Mexican] to reduce volume and increase profits. The Commission estimated that only 3 to 5 metric tons of pure fentanyl is needed to satisfy the entire annual U.S. consumption of illegally supplied opioids—a fraction of the estimated 47 metric tons of heroin and 145 metric tons of cocaine that were consumed in the United States in 2016.” If you download the pdf, see Fig. S1 on page XV for a summary of recommendations.
In a related article: Texas Strikes $225M Deal With Teva Over Opioid Crisis

Inactivated and live-attenuated seasonal influenza vaccines boost broadly neutralizing antibodies in children: “Repeated seasonal vaccination results in significant boosting of a durable bNAb [broadly neutralizing antibodies] response. Boosting of serological bNAb titers is comparable within inactivated and live attenuated (LAIV) vaccinees and declines with age.”

Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Study cohort, 2017–2019: “Sales increases in high nicotine e- cigarettes in 2017 did not translate to more smokers using these e-cigarettes to quit smoking. On average, using e-cigarettes for cessation in 2017 did not improve successful quitting or prevent relapse.”

Treatment of Tobacco Smoking: A Review: “Approximately 34 million people in the US smoke cigarettes and could potentially gain up to a decade of life expectancy by stopping smoking. First-line therapy should include both pharmacotherapy and behavioral support, with varenicline or combination NRT as preferred initial interventions.”

About healthcare IT

 How NFTs could transform health information exchange: “Personal (sometimes called “protected”) health information (PHI) is highly valued (1) and will become centrally important as big data and machine learning move to the forefront of health care and translational research. The current health information exchange (HIE) market is dominated by commercial and (to a lesser extent) not-for-profit entities and typically excludes patients. This can serve to undermine trust and create incentives for sharing data (2). Patients have limited agency in deciding which of their data is shared, with whom, and under what conditions. Within this context, new forms of digital ownership can inspire a digital marketplace for patient-controlled health data. We argue that nonfungible tokens (NFTs) or NFT-like frameworks can help incentivize a more democratized, transparent, and efficient system for HIE in which patients participate in decisions about how and with whom their PHI is shared.” 

Amazon Care rolls out telehealth services nationwide: “Amazon Care’s virtual health services are now available nationwide, and its in-person services will be rolled out in more than 20 new cities in 2022, Amazon said Feb. 8 in a post on its website.” 

About health technology

Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis:  “Here, we hypothesized that an arrangement of electrodes targeting the ensemble of dorsal roots involved in leg and trunk movements would result in superior efficacy, restoring more diverse motor activities after the most severe SCI. To test this hypothesis, we established a computational framework that informed the optimal arrangement of electrodes on a new paddle lead and guided its neurosurgical positioning. We also developed software supporting the rapid configuration of activity-specific stimulation programs that reproduced the natural activation of motor neurons underlying each activity. We tested these neurotechnologies in three individuals with complete sensorimotor paralysis as part of an ongoing clinical trial (www.clinicaltrials.gov identifier NCT02936453). Within a single day, activity-specific stimulation programs enabled these three individuals to stand, walk, cycle, swim and control trunk movements. Neurorehabilitation mediated sufficient improvement to restore these activities in community settings, opening a realistic path to support everyday mobility with EES in people with SCI.”
This technique is an extremely important innovation.

 

Today's News and Commentary

About Covid-19

CDC backs Moderna COVID-19 shots after full US approval: “The Centers for Disease Control and Prevention on Friday continued its endorsement of Moderna’s COVID-19 vaccine for adults, now that U.S. regulators have given the shots their full approval.
The decision has little practical effect. Tens of millions of Americans have already gotten Moderna shots, following its emergency authorization by the Food and Drug Administration more than a year ago. 
Earlier…, the FDA gave the product full licensure, following the kind of rigorous, time-consuming review given to other vaccines.”

 Walgreens, CVS lift rapid test purchase limits: Increased stocking of tests has eliminated limits in most locations.

 U.S. considers lengthening gap between first 2 COVID shots to 8 weeks: “U.S. health officials on Friday said they are considering lengthening the recommended interval between the first two doses of the most widely used COVID-19 vaccines to eight weeks to lower the risk of heart inflammation and improve their effectiveness.”

High Rates of Rapid Antigen Test Positivity After 5 days of Isolation for COVID-19: PREPRINT, NOT YET PEER REVIEWED.
”These results indicate that a substantial proportion [~40%] of individuals with COVID-19 are likely still contagious after day 5 of illness regardless of symptom status. Early liberation from isolation should be undertaken only with the understanding that inclusion of individuals on day 6-10 of illness in community or work settings may increase the risk of COVID-19 spread to others which, in turn, may undermine the intended benefits to staffing by resulting in more sick workers.”

16 states renew fight against CMS' vaccine rule: No, this article is not a few months old. It is from today.
”Sixteen state attorneys general asked a federal judge Feb. 4 to block the federal vaccine mandate for healthcare workers…  
Fourteen of the attorneys general are from the 24 states that were affected by the Jan. 13 Supreme Court decision that upheld CMS' vaccination mandate for eligible staff at healthcare facilities participating in the Medicare and Medicaid programs.”
As before, the issue claimed by the plaintiffs is that the requirements reduce the availability of already critical staff shortages. These shortages have become worse with omicron-variant infections.

About health insurance

 Association of Health Insurance Literacy With Enrollment in Traditional Medicare, Medicare Advantage, and Plan Characteristics Within Medicare Advantage: “In this cross-sectional study of 6627 Medicare beneficiaries, higher health insurance literacy—particularly, annual review and comparison of coverage choices—was associated with higher Medicare Advantage enrollment and choice of low-cost or high-rated Medicare Advantage plans. However, health insurance literacy was low among Medicare beneficiaries with low socioeconomic status.
Meaning  These findings suggest that policy makers should develop programs to make health insurance information accessible and understandable and to encourage annual review and comparison of coverage options, especially for vulnerable populations.”

Medical Crowdfunding and Disparities in Health Care Access in the United States, 2016‒2020: “Campaigns raised more than $2 billion from 21.7 million donations between 2016 and 2020. Returns were highly unequal, and success was low, especially in 2020: only 12% of campaigns met their goals, and 16% received no donations at all. Campaigns in 2020 raised substantially less money in areas with more medical debt, higher uninsurance rates, and lower incomes.
Conclusions. Despite its popularity and portrayals as an ad-hoc safety net, medical crowdfunding is misaligned with key indicators of health financing needs in the United States. It is best positioned to help in populations that need it the least.”

About pharma

 Top 10 most anticipated drug launches of 2022: FYI

FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers: “FDA is announcing the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providersas required by the Drug Supply Chain Security Act (DSCSA). The proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.
Requirements for wholesale drug distributors currently vary significantly across state lines creating a patchwork system. In passing DSCSA, Congress believed a uniform national standard would address this issue.”

The hits keep coming: Biogen's Aduhelm marketing, approval under fire in new FTC and SEC probes: “The Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) have launched two separate investigations into Biogen and its troubled Alzheimer’s med, the company revealed in an annual securities filing Thursday.
The FTC has made a civil investigative demand—a type of administrative subpoena—in pursuit of documents related to Aduhelm’s marketing and approval, plus healthcare sites, the company said.
The SEC, meanwhile, has launched a separate inquiry that also seeks marketing and approval information on the beleaguered anti-amyloid antibody.”

In a victory for medical journals, Pacira loses a libel lawsuit over ‘faulty scientific research’ allegations: “A federal judge has dismissed an unusual libel lawsuit brought by Pacira BioSciences that claimed a medical journal, its editor, and the authors of several papers published articles that were based on “faulty scientific research” that portrayed its only medicine as ineffective.
Pacira alleged the papers, which were published early last year in the journal Anesthesiology, reflected a ‘bias’ against its Exparel painkiller and ‘disparaged’ the drug, as we noted at the time.”

Sanofi drops Pasteur, Genzyme names as it simplifies brand: “Sanofi on Thursday unveiled a new corporate brand and said that it will no longer use the Genzyme and Pasteur names as it moves forward with one shared identity. The overhaul follows a similar move made in 2011, when the company dropped Aventis from its name in an effort to simplify its brand.”

About the public’s health

 Weekly U.S. Influenza Surveillance Report: Some key points”

  • “The majority of influenza viruses detected are A(H3N2). Most of the H3N2 viruses identified so far this season are genetically closely related to the vaccine virus. Some viruses show antigenic differences that developed as H3N2 viruses have continued to evolve.

  • The percentage of outpatient visits due to respiratory illness decreased nationally again this week and is now below baseline. Influenza is contributing to levels of respiratory illness, but other respiratory viruses are also circulating. The relative contribution of influenza varies by location.

  • The number of hospital admissions reported to HHS Protect declined slightly again this week.

  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.”

Global urban temporal trends in fine particulate matter (PM2·5) and attributable health burdens: estimates from global datasets: “Although regional averages of urban PM2·5 concentrations decreased between the years 2000 and 2019, we found considerable heterogeneity in trends of PM2·5 concentrations between urban areas. Approximately 86% (2·5 billion inhabitants) of urban inhabitants lived in urban areas that exceeded WHO's 2005 guideline annual average PM2·5 (10 μg/m3), resulting in an excess of 1·8 million (95% CI 1·34 million–2·3 million) deaths in 2019. [Emphasis addded]Regional averages of PM2·5-attributable deaths increased in all regions except for Europe and the Americas, driven by changes in population numbers, age structures, and disease rates. In some cities, PM2·5-attributable mortality increased despite decreases in PM2·5 concentrations, resulting from shifting age distributions and rates of non-communicable disease.”

Workers of color and LGBTQ employees face healthcare inequity regardless of income: “Management consulting firm McKinsey and Company’s report on healthcare inequity in the workplace found that 69% of employees of color and 66% of LGBTQ employees who earn up to $100,000 a year experienced two or more unmet basic needs, such as personal safety, social support and food security. Meanwhile, only 49% of white employees felt similarly. Workers with one or more unmet basic needs were around 2.4 times more likely to have not received needed physical healthcare while focusing on immediate concerns like housing and safety.”

New highly virulent and damaging HIV variant discovered in the Netherlands: “Individuals infected with the new “VB variant” (for virulent subtype B) showed significant differences before antiretroviral treatment compared with individuals infected with other HIV variants:

• Individuals with the VB variant had a viral load (the level of the virus in the blood) between 3.5 and 5.5 times higher.
• In addition, the rate of CD4 cell decline (the hallmark of immune system damage by HIV) occurred twice as fast in individuals with the VB variant, placing them at risk of developing AIDS much more rapidly.
• Individuals with the VB variant also showed an increased risk of transmitting the virus to others.

Reassuringly, after starting treatment, individuals with the VB variant had similar immune system recovery and survival to individuals with other HIV variants. However, the researchers stress that because the VB variant causes a more rapid decline in immune system strength, this makes it critical that individuals are diagnosed early and start treatment as soon as possible.”

About healthcare IT

 Investment firm will take SOC Telemed private in deal valued at $300M: “Healthcare investment firm Patient Square Capital plans to take SOC Telemed private in a deal that values the company at roughly $304.2 million…
Founded in 2004, SOC provides acute telemedicine services to nearly 1,000 facilities, including more than 700 hospitals across 47 states and services 19 of the 25 largest health systems.”

About health technology

Scientists Reveal "Rosetta Stone" of Immune Cell Function: CRISPR genome editing has served as a powerful tool for deleting or altering DNA sequences and studying the resulting effect. A recent variation, known as CRISPRa, allows researchers to forcibly activate genes—rather than edit them—in human cells. Now, researchers at Gladstone Institutes and UC San Francisco (UCSF) have adapted the CRISPRa system to human immune cells…
The scientists activated each gene in the genome in different cells, enabling them to test almost 20,000 genes in parallel. This allowed them to quickly learn the rules about which genes provide the most powerful levers to reprogram cell functions in ways that could eventually lead to more powerful immunotherapies.”

 Abbott delivers first implant of its dual-chamber leadless pacemaker in a clinical study: “Abbott has taken a major step in the development of its dual-chamber leadless pacemaker technology, with the company’s first patient receiving two miniaturized, implanted devices within different areas of the heart that synchronize themselves wirelessly to help control the muscle beat by beat.
Traditional pacemaker systems have included a separate power generator placed under the skin near the collarbone, which then connects to the heart with a series of wires. But a new generation of leadless pacemakers, at about one-tenth the size, can be planted inside the heart itself and anchored directly to the muscle wall in a less invasive procedure.”

Zimmer Biomet plots $1B revenue for spine, dental spinoff ZimVie, sets launch date: “When the separation is complete, the standalone public company—dubbed ZimVie after its progenitor and the French word for “life”—will begin trading on the Nasdaq as ‘ZIMV.’ Zimmer Biomet will retain a stake of just under 20% of ZimVie’s outstanding shares of common stock, though the elder company said it would ultimately divest those shares in an unspecified ‘tax-efficient manner.’
The remaining 80% of ZimVie’s outstanding stock will go to current Zimmer shareholders, distributed as one ZimVie share for every 10 Zimmer shares they own.” 

Today's News and Commentary

About Covid-19

COVID-19 Vaccination Demographics in the United States, National: CDC’s comprehensive, current database of vaccination demographics.

Prevalence and Durability of SARS-CoV-2 Antibodies Among Unvaccinated US Adults by History of COVID-19: “In this cross-sectional study of unvaccinated US adults, antibodies were detected in 99% of individuals who reported a positive COVID-19 test result, in 55% who believed they had COVID-19 but were never tested, and in 11% who believed they had never had COVID-19 infection. Anti-RBD levels were observed after a positive COVID-19 test result up to 20 months, extending previous 6-month durability data.”

Vaccine refusal tied to 4,934 healthcare job cuts in January: U.S.-based companies announced 19,064 job cuts in January, and 5,757 workers lost their jobs because they refused to get vaccinated against COVID-19, according to a report from Challenger, Gray & Christmas, an executive outplacement and coaching firm. 
Of the job cuts for vaccine refusal in January, 4,934 were from healthcare providers, according to the report. The healthcare industry had the most job cuts in January, with 5,053.” 

 San Francisco allowing extra booster shot for Johnson & Johnson recipients: “In a break with federal guidance, San Francisco health officials are allowing adult residents who received the Johnson & Johnson coronavirus vaccine to get a second booster shot.”

About health insurance

Kaiser Permanente's special California Medicaid contract raises concerns: “California awarded Kaiser Permanente an exclusive Medicaid contract that would allow it to hand-pick enrollees as it grows in the state, according to Kaiser Health News. 
However, the contract, which was negotiated via a secret meeting between the payer and the state, raises concerns among Kaiser Permanente's competitors that the patients left for them will be riskier and potentially more costly…
In a statement, Kaiser Permanente said the plan was struck to uniquely help the payer — which also operates as a provider — to grow beyond its capacity.”

About hospitals and healthcare systems

 Hospital CEOs' No. 1 concern is staffing for 1st time in 17 years: “Hospital CEOs ranked personnel shortages as their No. 1 concern in 2021. Financial challenges, which consistently held the top spot since 2004, were listed the second-most pressing concern in the American College of Healthcare Executives' annual survey.”

This is why hospitals need more time to pay off Medicare loans: “The current payback terms, which Congress eased in 2020, start at 25% one year after the initial payment for 11 months. After that, the payback increases to 50% for six months. If everything is not paid off in these 29 months, the agency will set an interest rate of 4%.
In a  letter sent to President Joe Biden and Congressional leaders on Jan. 19, hospitals and health care systems have made a number of requests, including for loan repayment deferrals. The letter acknowledges that many providers have already paid the money in full.” The letter is short and worth reading.

About pharma

Estimation of Potential Savings Associated With Switching Medication Formulation: “In this study, we found that switching medication formulations can reduce expenditure on the drugs we analyzed by more than 40%.”

 Mallinckrodt wins approval of restructuring plan, opioid deal: “Pharmaceutical company Mallinckrodt PLC on Thursday won court approval of its reorganization plan, which includes a $1.7 billion settlement of opioid-related litigation, bringing its 16-month bankruptcy close to an end.
U.S. Bankruptcy Judge John Dorsey in Wilmington, Delaware signed off on the plan in a 103-page written decision. In addition to settling thousands of lawsuits accusing it of deceptively marketing its opioids, the plan allows Mallinckrodt to reduce $5.3 billion in debt by $1.3 billion and hands control of the reorganized company to creditors.” 

  About healthcare personnel

 Biden administration announces $19 million for new residency positions: “The Biden administration on Thursday made $19 million in grants available to train primary care residents in rural and under-served communities, part of an effort to address physician shortages. The funding will support an additional 120 residency slots at community-based ambulatory patient care centers. "This funding provides our primary care workforce with opportunities to train in areas where they can make a profound impact, and is one of the many steps we're taking to address long-standing health disparities," Health and Human Services Secretary Xavier Becerra said.” 

About diagnostics

 Labcorp launches online platform for ordering at-home tests, scheduling in-person appointments: “With Labcorp OnDemand, consumers can choose from a wide range of tests and multitest packages, all available without a physician’s referral. Depending on the type, the diagnostics can either be ordered for at-home sample collection or the buyer will be prompted to schedule an appointment at one of Labcorp’s patient service centers, 2,000 of which are located in Walgreens stores and standalone labs across the U.S.
Regardless of how the sample is collected, after it’s been processed by Labcorp, the results are automatically available on the OnDemand platform’s online portal. The resulting report not only explains each test’s results and highlights potential areas of concern but can also be shared with healthcare providers.”
This process is a marked departure from the requirement for a physician’s order for most tests. The question of insurance payment for such self-ordered tests was not discussed in the article. 

About Covid-19

Covid sufferers become infectious quicker than first thought, study shows: “The UK government-funded ‘human challenge’ trial found that levels of the Sars-Cov-2 virus in the nose and throat peaked after five days, though participants remained infectious for an average of nine days and a maximum of 12 days after exposure. The researchers said their results support guidance that people should quarantine for 10 days after they first feel Covid symptoms or have a positive test result. The study took place in a special unit at the Royal Free Hospital in London. Eighteen of the 34 volunteers aged 18 to 29 became infected after receiving a low dose of the original Sars-Cov-2 strain via droplets in the nose.”
Another important finding of the study was: “No quantitative correlation was noted between VL [viral load] and symptoms, with high VLs even in asymptomatic infection…”

KFF COVID-19 Vaccine Monitor: January 2022 Parents And Kids Update: “Key Findings

  • In the midst of the latest surge of the omicron COVID-19 variant, the share of parents who say their child has gotten at least one shot of a COVID-19 vaccine increased between November and January. Six in ten parents of 12-17 year-olds now say their child has received at least one shot (61%, up from 49% in November), as do one-third of parents of 5-11 year-olds (33%, up from 16% in November). Three in ten parents of children under 5 say they’ll get their child vaccinated right away once a vaccine is approved for their age group, up somewhat from one in five in July.

  • One in five (21%) parents of vaccinated teens say their child has already received a COVID-19 booster, and around two-thirds (65%) say they will “definitely” or “probably get” one. Just one in seven parents of vaccinated 12-17 year-olds say their teen “probably” or “definitely won’t” get the booster (14%).

  • Half of parents report being worried about their child becoming seriously sick from the coronavirus, including substantially higher shares among parents who are Black or Hispanic and those with lower incomes.

  • Four in ten parents of school-age children report some type of disruption to their child’s in-person learning in the first month of the year, including needing to quarantine, schools shutting down in-person classes, or parents choosing to keep children home due to safety concerns. Most (63%) say their child’s school did not provide access to COVID-19 testing before returning to classes in January.”

Army to begin discharging soldiers who refuse coronavirus vaccination: “The U.S. Army announced Wednesday that soldiers who refuse coronavirus vaccinations will be immediately discharged.
The Army order, which applies to regular soldiers, active-duty reservists and cadets, comes in response to the Pentagon’s August order mandating vaccination for all U.S. troops… The Army’s deadline was in December.”

AMA announces CPT update for pediatric COVID-19 vaccine candidate: “For quick reference, the article has the new product and administration codes assigned to the Pfizer-BioNTech COVID-19 vaccine for children in the age range of 6 months to 5 years is:

Biden-Harris Administration Will Cover Free Over-the-Counter COVID-19 Tests Through Medicare: “As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).”

BD doubles COVID sales forecast for 2022 even as steep testing dropoff leads to revenue loss: “In BD’s case, even though the medtech giant spent the last year introducing new devices and diagnostics and making acquisitions to break into new businesses, it still reported a drop in revenue for the first quarter of its 2022 fiscal year, attributed almost solely to a sharp dip in COVID-related earnings.
BD raked in just under $5 billion for the three-month period ending Dec. 31. That marks a 6% decline compared to the first fiscal quarter of the previous year, when it took in $5.3 billion.
Subtracting the impact of COVID-only diagnostic testing from those totals, however, tells a completely different story. Without those test sales, BD earned $4.8 billion for the quarter, which represents an increase of 8.1% over the previous year’s $4.5 billion COVID-less haul.”

 At Nursing Homes, Long Waits for Results Render COVID Tests 'Useless': “The double whammy of slower turnaround times for lab-based PCR tests and a shortage of rapid antigen tests has strained facilities where quickly identifying infections is crucial for keeping a highly vulnerable population safe.
A KHN [Kaiser Health News]analysis of data from the Centers for Medicare & Medicaid Services finds that 25% of nursing homes that sent tests to a lab waited an average of three or more days for results as of Jan. 16. In early December, that number was 12%.”

Unvaccinated to Pay More Out-of-Pocket Under New Covid Policies: “People who choose not to get vaccinated can’t be denied health insurance, but they could be forced to pay more for their coverage. 
The Affordable Care Act prohibits private health insurers from denying someone coverage or charging higher premiums because of a pre-existing condition or their health status, which would include whether or not they’re vaccinated. 
Short-term health plans are an exception. Those plans could turn down applicants who refuse the Covid-19 vaccine because they aren’t subject to ACA regulations.
The ACA allows employer wellness programs to charge unvaccinated workers a surcharge as long as it doesn’t discriminate against people with disabilities.”

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH [CDRH] PROGRAMMATIC ACCOMPLISHMENTS EMERGENCY USE AUTHORIZATIONS: A review of its activities during the pandemic, which involve not only test reviews but also PPE approvals. In summary: “CDRH authorized 15 times more Emergency Use Authorization (EUA) requests than during all previous public health emergencies combined.” Translates to 2039 medical devices authorized (EUA and full market authorizations).

About health insurance
 QUALITY PAYMENT PROGRAM [QPP] PARTICIPATION IN 2020: RESULTS AT-A-GLANCE: Good graphical presentation of latest results from the QPP. Some highlights:
For 2020:

--”89.11% were engaged in QPP in 2020 

--Fewer clinicians participated in MIPS APMs than in 2019  (2020 – 398,719; 2019 – 416,201) 

--25.72% received reweighting of one or more MIPS performance categories 

Snapshot of 2022 Payment Adjustments for MIPS Eligible Clinicians: 

--81% will receive an additional adjustment for exceptional performance 
933,547 Total clinicians who will receive a MIPS payment adjustment (positive, neutral, or negative) 

--10% will receive a positive payment adjustment 

7% will receive a neutral adjustment (no increase of decrease) 

2% will receive a negative payment adjustment

 Cigna beats the Street with $1.1B in profit for Q4: “Cigna brought in $1.1 billion in earnings for the fourth quarter, down from a $4.1 billion haul in the same period in 2020.
Revenues for the quarter were $45.7 billion, up from $41.7 billion in the prior-year quarter, the company said in its earnings report released Thursday. Both figures exceeded Wall Street's expectations, according to Zacks Investment Research.
For full-year 2021, Cigna earned $5.4 billion in profit and $174.1 billion in revenue. By comparison, the insurer raked in $8.5 billion in profit for 2020 and $160.4 billion in revenue.”

CMS Releases 2023 Medicare Advantage and Part D Advance Notice: “CMS is requesting input on a potential change to the MA and Part D Star Ratings that would take into account how well each plan advances health equity. CMS is also requesting comment on including a quality measure in MA and Part D Star Ratings that would specifically assess how often plans are screening for common health-related social needs, such as food insecurity, housing insecurity, and transportation problems.”

Next big health crisis: 15M people could lose Medicaid when pandemic ends: “States expect the current federal public health emergency to expire this year, triggering a requirement that they must comb through their Medicaid rolls to see who is no longer eligible. Those audits, which have been suspended for the past two years, could lead to as many as 15 million people losing their health insurance, including 6 million children, according to an analysis from the Urban Institute.”

Medicare Advantage Plans Can Increase Income by Almost 8%: “Centers for Medicare and Medicaid Services on Wednesday proposed a 7.98% increase in Medicare Advantage payments in 2023 as they anticipate future changes to their risk adjustment model.
In a proposed fee policy for 2023, the agency solicited feedback on whether the risk adjustment model and MA star ratings could account for the impact of the social determinants of health and health equity.
Under the proposed changes, revenue for Medicare Advantage organizations could increase by nearly 8% next year compared to 2022. The proposed increase is nearly double the 4.08% salary increase planned for 2022.
This projection includes a 3.5% increase in the MA risk score trend, which is a median increase in risk scores. Risk estimates take into account a participant’s expected costs and tend to be higher when participants are sicker. The forecast also takes into account an effective growth rate of 4.75%.”

Georgia nurse practitioner convicted of health care fraud in complex telemedicine fraud scheme: “As described in court documents and testimony, Beaufils, as a nurse practitioner, facilitated orders for more than 3,000 orthotic braces that generated more than $3 million in fraudulent or excessive charges to Medicare. Co-conspirators captured the identities of senior citizens, identified through a telemarketing scheme, and bundled that information as ‘leads.’
Beaufils then signed her name to fake medical records, in which she falsely claimed she provided examinations of those patients, and then created orders for orthotic braces for patients she never met or spoke with – including a knee brace for an amputee, and a back brace for a recently deceased patient – and other durable medical equipment, in exchange for money. Beaufils’s fraudulent orders were then sold to companies that would generate reimbursement from Medicare.”

About hospitals and healthcare systems

Bottom-tier hospitals got better at infection control, but still hit with 1% Medicare pay cuts: “Hospitals with the worst rates patient infections have, on average, improved since 2018. Despite moving the needle on healthcare-associated infections, however, there will always be losers under the CMS Hospital-Acquired Condition Reduction Program. The bottom 25%—749 hospitals—are subject to 1% Medicare payment cuts in fiscal 2022. The Affordable Care Act established the penalty program as a way to put a spotlight on persistent patient safety problems. But the hospital industry questions whether the system is is fair, especially because healthcare-associated infections were declining prior to the COVID-19 pandemic.”

 Union accuses HCA of widespread Medicare fraud in 45-page report: “Service Employees International Union is taking aim at Nashville, Tenn.-based HCA Healthcare, accusing the hospital operator of maximizing profits at the expense of patient care and obtaining more than $1 billion in fraudulent payments from Medicare…
The Medicare fraud allegations stem from SEIU's analysis of the average emergency department admission rate among HCA hospitals. The union found that HCA hospitals' admission rates exceeded the national average by more than 5 percent from 2014 to 2019. In some states, like Texas and California, the average HCA ED admission rate is 10 percent higher than the state average, the report found.”

 Association of Emergency Department Pediatric Readiness With Mortality to 1 Year Among Injured Children Treated at Trauma Centers: “In this cohort study of 88 071 injured children from 8 states cared for in 146 EDs of trauma centers in 15 states, receiving initial care in an ED in the highest quartile of readiness was associated with 30% lower hazard of death to 1 year. The findings were consistent after removing children who died early…
Results of this study indicate high ED readiness is independently associated with long-term survival among injured children.”

Drug prices for hospitals to increase 3% in 2022, with remdesivir topping adalimumab in total spend: “Drug prices for hospitals are expected to increase by 3.09% in the coming year with newfound COVID-19 treatment remdesivir (Veklury) edging out longtime leader adalimumab (Humira) as hospitals’ top drug by total spend, according to a recent market outlook report from Vizient…
Remdesivir alone comprised 3.42%, more than $1 billion, of total Vizient member spend, according to the group’s report. It also led the way for anti-infective drugs, comprising 4% of total spend within the class and outstripping the second product, rifaximin (Xifaxan), by a factor of 10.”

About pharma

Pharma Marketing in the Era of COVID: This monograph is not about Covid, but about how the pandemic changed pharma marketing. Several trends are noteworthy.
First, obviously, is an accelerated trend to digital communication media.
Second "is personalising content for customers. While at least 77 percent of pharma marketers believe that personalisation of content is a high priority, only 25 percent have access to the right technology to do so.” Third, as “almost all in-person meetings were cancelled in 2020, and many took a hybrid approach through 2021, the importance of digital opinion leaders (DOLs) has grown. As physicians increasingly turn to social media for knowledge translation and education, DOLs – keen scientific minds with social media savvy – have become an important marketing tool. DOLs tend to be different to traditional key opinion leaders (KOLs). Academic KOLs receive their status based on their experience, seniority and roles within an institution. A DOL’s stature is based on their online influence, which is not necessarily related to their years of experience or position.10 However, some KOLs have been making the transition to DOL.”

Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: “This meta-analysis and systematic review of 31 cancer biosimilar studies of 3 reference products involving 12 310 patients found that, compared with pivotal trials of reference drugs, studies of 3 cancer drugs with biosimilars available at the time of the analysis were, on average, larger, more often a randomized clinical trial, and more often double blinded. Meta-analyses showed biosimilars to be as effective as their reference products in all disease settings…
This study suggests that studies of biosimilars for treating cancer have design elements of rigorous trials and show equivalent effectiveness to their reference products.”
See, also, the accompanying editorial: Cancer Biosimilars—A Regulatory Success So Far, but Value Still to Be Determined

 Astellas maintains full-year outlook, despite drop in Q3 profit: “Astellas maintained its full fiscal-year forecast of sales totalling JPY 1.3 trillion ($11.4 billion) on profit of JPY 174 billion ($1.5 billion).” 

Takeda boosts full-year outlook: “Takeda now expects mid-single-digit revenue growth in fiscal year 2021 to JPY 3.5 trillion ($30.5 billion), up from a prior estimate of JPY 3.4 trillion ($29.6 billion). Meanwhile, profit is now seen at JPY 242.5 billion ($2.1 billion), lifted from an earlier forecast of JPY 184.3 billion ($1.6 billion).”

AbbVie's blockbuster eye drug Restasis under threat as FDA approves Viatris' copycat: “The FDA has approved Viatris' generic to AbbVie's chronic dry eye treatment Restasis, which generated $1.23 billion in U.S. sales last year. Patents on the drug began expiring in 2014, Viatris' Mylan Pharmaceuticals has noted, but generics haven't been able to pass through the FDA's gate until today despite years of regulatory efforts.”

Biogen's Aduhelm call to action backfires as CMS receives many more comments in favor of restrictive coverage: analyst: “During a January Q&A call with investors, Biogen chief Michel Vounatsos pressed Aduhelm supporters to fight the Centers for Medicare & Medicaid Services’ (CMS') restrictive coverage proposal on the beleaguered Alzheimer’s drug. Turns out, however, most people think CMS made the right call—at least according to one group of analysts.
The public supports CMS’ decision, which would limit Medicare coverage for antibeta-amyloid drugs like Aduhelm to patients enrolled in approved clinical studies, according to a BofA Securities analysis of more than 1,000 comments received by CMS.
There were thrice as many comments in support of CMS’ National Coverage Determination (NCD) and questioning Aduhelm’s efficacy as there were comments asking for a proposal tweak, BofA’s Geoff Meacham wrote in a note to clients Tuesday.
But are all those comments legit? More than 500 letters posted in support of CMS’ restrictive coverage were generated through a campaign run by non-profit media outlet More Perfect Union, a Biogen spokesperson said over email.”

J&J's Janssen inks $1B biobucks pact for Mersana's ADC tech in 3 targets: “After expanding its antibody-drug conjugate (ADC) deal with Synaffix last November to the tune of $1 billion, Mersana Therapeutics is back with another major deal. This time, Johnson & Johnson's Janssen unit is doling out $40 million upfront and more than $1 billion in biobucks for ADCs spanning three targets. 
The pair will work together to research target candidates during preclinical development. J&J's biotech unit will provide proprietary antibodies, and Mersana will contribute its Dolasynthen platform to help find the new ADC product candidates.”

Amgen enters hot protein degradation field with $500M biobucks deal with Plexium: “Amgen is breaking into the protein degradation space in a $500 million biobucks deal with Plexium just weeks after lining up for RNA degraders in a tie-up with Arrakis. 
The California neighbors entered a multi-year research collaboration and licensing agreement for new protein degradation therapies initially focused on two programs in cancer and other serious diseases. Amgen will dish out the milestones in exchange for a commercial license to the two programs.”

About the public’s health

 Appeals court restores Tennessee Down syndrome abortion ban: “A federal appeals court on Wednesday once again reinstated a Tennessee ban on abortions because of a prenatal diagnosis of Down syndrome, or because of the race or gender of the fetus.
The ban is part of a sweeping anti-abortion measure that has faced multiple legal challenges since it was enacted in 2020 by Republican Gov. Bill Lee. Notably, the law banned abortion as early as six weeks — a time frame when most women don’t know they’re pregnant — but that portion has remained blocked from going into effect.”

Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission: For those interested in an overview, read the introductory comments in the seven Domains the Commission identifies.

Development of an Open Database of Genes Included in Hereditary Cancer Genetic Testing Panels Available From Major Sources in the US: “Hereditary cancer syndromes occur when germline variants increase an individual’s risk of developing cancer. Genetic testing can identify these variants, enabling clinicians to intervene through increased screening or prophylactic surgery.”
However, databases for these genes are not synched. Among other findings, the study found: “A total of 706 genes were included in at least 1 laboratory’s panel. Only 13 genes were included by all 17 companies. Only 110 genes appeared in at least 1 clinical guideline for hereditary cancer or had a ClinGen gene-disease relationship assessment.” Hence, the need for an open database.

About healthcare IT

Deploying digital health tools within large, complex health systems: key considerations for adoption and implementation:  “In this piece, we put forth nine dimensions along which clinically validated digital health tools should be examined by health systems prior to adoption, and propose strategies for selecting digital health tools and planning for implementation in this setting. By evaluating prospective tools along these dimensions, health systems can evaluate which existing digital health solutions are worthy of adoption, ensure they have sufficient resources for deployment and long-term use, and devise a strategic plan for implementation.”
This article is well worth reading. It is a thoughtful, management tool that fulfills the purpose of the headline.

 National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services:

  • “Overall during the study period, we found that one in four respondents (23.1%) reported use of telehealth services in the previous four weeks.

  • Telehealth use rates were similar (21.1-26.8%) among most demographic subgroups but were much lower among those who were uninsured (9.4%) and young adults ages 18 to 24 (17.6%).

  • The highest rates of telehealth visits were among those with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and those earning less than $25,000 (26.7%).

  • There were significant disparities among subgroups in terms of audio versus video telehealth use. Among telehealth users, the highest share of visits that utilized video services occurred among young adults ages 18 to 24 (72.5%), those earning at least $100,000 (68.8%), those with private insurance (65.9%),andWhiteindividuals(61.9%). Videotelehealthrateswerelowestamongthosewithouta high school diploma (38.1%), adults ages 65 and older (43.5%), and Latino (50.7%), Asian (51.3%) and Black individuals (53.6%).

  • Policy efforts to ensure equitable access to telehealth, in particular video-enabled telehealth, are needed to ensure that disparitiesthat emerged during the pandemic do not become permanent.”
    Comment: An additional problem not mentioned in the summary is need for expansion and affordability of broadband access. See: As internet access limits telehealth’s reach, insurers are starting to cover the bill Nearly a quarter of adults in the U.S. don’t have broadband at home, network speeds are insufficient for video calls in much of rural America, and 15% struggle to pay for internet.”

Top 5 telehealth diagnoses in November 2021: “Across the U.S., mental health conditions were the No. 1 telehealth diagnosis in November 2021, according to new data from Fair Health.
Telehealth claim lines remained steady from October 2021 to November 2021, rising from 4.1 percent of all medical claim lines to 4.4 percent….
1.Mental health conditions: 62.2 percent
2.Acute respiratory disease and infections: 4.5 percent
3.Developmental disorders: 1.9 percent
4.Joint/soft tissue diseases and issues: 1.8 percent
5.COVID-19: 1.4 percent”

About healthcare personnel

 Strained US hospitals seek foreign nurses amid visa windfall: “There’s an unusually high number of green cards available this year for foreign professionals, including nurses, who want to move to the United States — twice as many as just a few years ago. That’s because U.S. consulates shut down during the coronavirus pandemic weren’t issuing visas to relatives of American citizens, and, by law, these unused slots now get transferred to eligible workers.”