Today's News and Commentary

About Covid-19

US faces wave of omicron deaths in coming weeks, models say: “The fast-moving omicron variant may cause less severe disease on average, but COVID-19 deaths in the U.S. are climbing and modelers forecast 50,000 to 300,000 more Americans could die by the time the wave subsides in mid-March.
The seven-day rolling average for daily new COVID-19 deaths in the U.S. has been trending upward since mid-November, reaching nearly 1,700 on Jan. 17 — still below the peak of 3,300 in January 2021. COVID-19 deaths among nursing home residents started rising slightly two weeks ago, although still at a rate 10 times less than last year before most residents were vaccinated.”
And in a related story: At least 20 percent of Americans have been infected with COVID-19, data show

Walgreens rolls out new COVID-19 data tracker to trace the spread of omicron, emerging variants: “Data captured in the Walgreens COVID-19 Indexcan track the spread of the omicron variant within 24 to 48 hours, more quickly than other methods, according to the companies. In addition to a national view, data can be reviewed by state.
The Walgreens COVID-19 Index is generated through the combination of Walgreens nationally representative PCR testing services with the associated PCR and next-generation sequencing (NGS) laboratory test results generated by Aegis Sciences.”

 Americans can now order free COVID-19 test kits; N95s to be shipped to pharmacies: “The federal government on Jan. 18 launched its website for Americans to request free rapid COVID-19 test kits be shipped to their homes. 
‘Every home in the U.S. is eligible to order four free at-home COVID-19 tests," the website — covidtests.gov — says. "The tests are completely free. Orders will usually ship in seven to 12 days. Order your tests now so you have them when you need them.’
There is a limit of one order per residential address. Each order includes four individual rapid test kits, and orders will start shipping later this month, the website says.”
Masks will be available in pharmacies starting next week with full program operation by early February.
Comment: If you live in an apartment/condo, make sure to include your unit # when ordering tests. Some people have been blocked because the site records registrants by address.

Pfizer's oral COVID-19 treatment shows efficacy against Omicron: “Findings from the Phase II/III EPIC-HR trial showed that Paxlovid reduced the risk of hospitalisations or death by 89% compared to placebo, when taken within three days of symptom onset, and by 88% when taken within five days. 
Two of the studies in question were conducted by Pfizer.
Commentary: Good news. But try to get this medication, likely to be in short supply.

Frequency of Adverse Events [AE] in the Placebo Arms of COVID-19 Vaccine Trials: Systemic “AEs were experienced by 35% of placebo recipients after the first dose and 32% after the second. Significantly more AEs were reported in the vaccine groups, but AEs in placebo arms (‘nocebo responses’) accounted for 76% of systemic AEs after the first COVID-19 vaccine dose and 52% after the second dose…
This study found that the rate of nocebo responses in placebo arms of COVID-19 vaccine trials was substantial; this finding should be considered in public vaccination programs.”

About health insurance

Obamacare enrollment hits record high after Biden makes post-Trump tweaks to health insurance program: “The official final enrollment number has yet to be tallied. But federal health officials noted that even before the deadline, a whopping 14.2 million people nationally had signed up for coverage…
The big surge came amid boosted financial assistance for enrollments, a wider window for sign-ups, the continuing health effects of the Covid-19 pandemic, which has claimed the lives of more than 850,000 Americans, and the touting of the health-care reform law by the president.”

 UnitedHealth Group reports $4.1B in profit for Q4, $17.3B for full-year 2021: “UnitedHealth Group earned $4.1 billion in profit for the fourth quarter of 2021, bringing its total profit for the year to $17.3 billion, according to the company's earnings report released Wednesday morning.
The results beat Wall Street expectations…
Total revenue for 2021 was $287.6 billion, according to the report.
For comparison, UnitedHealth Group reported $2.2 billion in profit and $65.5 billion in revenue for the fourth quarter of 2020.
For the full year 2020, the company reported $15.4 billion in profit and $257.1 billion in revenue, according to the report.”

About hospitals and healthcare systems

 Hospitals forced to delay patient discharges as nursing homes and rehab centers face major staff shortages: “With nursing homes, skilled nursing facilities (SNFs) and other downstream care settings in a bind, acute care hospitals are having a harder time discharging patients and clearing beds for new arrivals.
The result is not only a capacity issue for facilities facing an influx of COVID-19 cases but unnecessarily longer stays that redouble the demand for costly staff and supplies.”

About pharma

 US Insurer Spending on Ivermectin Prescriptions for COVID-19: “Findings suggest that insurers heavily subsidized the costs of ivermectin prescriptions for COVID-19, even though economic theory holds that insurers should not cover ineffective care. Wasteful insurer spending on these prescriptions, estimated at $2.5 million in the week of August 13, 2021, would extrapolate to $129.7 million annually.”
Comment: Prescriptions have much information associated with them. The one key factor not included is the reason the medication was ordered, i.e., the diagnosis. With all the data included in EMRs, the transition to including this item should not be difficult. It is important to track this information to accurately assess prescriptions ordered for non-FDA approved uses as well as conditions for which insurance coverage is not in force.

Endo to Settle With State of Florida for $65 Million for Role in Opioid Epidemic: “Endo International has agreed to pay up to $65 million to resolve claims by the state of Florida and local governments who claim that the company helped fuel the U.S. opioid epidemic which led to hundreds of thousands of overdose deaths over two decades.
The deal follows Endo’s $63 million settlement in December with Texas over the drugmaker’s role in the opioid crisis.”

Did BMS set up a subsidiary to avoid paying $1.4B in U.S. taxes? The Senate finance chairman is on the case: In a letter to BMS CEO Giovanni Caforio, Sen. Ron Wyden wrote that he wants to learn more about how the company reduced its tax rate from about 25% in 2010 and 2011 to -6.9% in 2012. The Senator cites reporting from the New York Times to write that BMS used "offshore subsidiaries to allegedly avoid paying as much as $1.4 billion in U.S. taxes" with the help of advisors at PwC and White & Case. Last April, The New York Times reported that the IRS found BMS' tax setup in violation of anti-abuse provisions and was seeking up to $1.38 billion.”

Altos Labs launches with the goal to transform medicine through cellular rejuvenation programming: “Altos Labs™ (Altos™) launched today as a new biotechnology company dedicated to unraveling the deep biology of cellular rejuvenation programming. Altos' mission is to restore cell health and resilience to reverse disease, injury, and the disabilities that can occur throughout life.”
The company will initially be based in the San Francisco Bay Area, San Diego, and in Cambridge, UK, with significant collaborations in Japan. It starts with $3B fully committed from Hal Barron and other biotech veterans.

About the public’s health

 Assessment of US Preventive Services Task Force Guideline–Concordant Cervical Cancer Screening Rates and Reasons for Underscreening by Age, Race and Ethnicity, Sexual Orientation, Rurality, and Insurance, 2005 to 2019: “In this cross-sectional study of 20 557 women (weighted, 113 million women) eligible for cervical cancer screening in the US, the proportion of women without up-to-date screening significantly increased from 14.4% in 2005 to 23.0% in 2019 among all sociodemographic groups, with disparities found across different sociodemographic groups and lack of knowledge reported as the biggest barrier to receiving screening...
This study found that guideline-concordant cervical cancer screening rates decreased between 2005 and 2019; campaigns addressing patient knowledge and practitioner communication may help to improve cervical cancer screening rates, and cultural adaptation of interventions is needed to reduce existing disparities.”

About healthcare IT

As TEFCA goes live, HHS hits major interoperability milestone: “Five years in the making, the nation's top health IT agency released Tuesday the Trusted Exchange Framework and Common Agreement, a critical step in establishing a nationwide data-sharing network.
The long-awaited interoperability framework (PDF), called TEFCA, was mandated by the 21st Century Cures Act back in 2016 and was designed to improve data sharing between health information networks.
The Office of the National Coordinator for Health, within HHS, released the first draft of the TEFCA back in January 2018. The framework provides the policies, procedures and technical standards necessary to exchange patient records and health information between providers, state and regional health information exchanges and federal agencies."

What types of mental health apps actually work? A sweeping new analysis finds the data is sparse: “The meta-review, published on Tuesday in PLOS Digital Health, examined 14 meta-analyses that focused specifically on randomized control trials for mental health interventions, including treatments for depression, anxiety, and smoking cessation. In total, the review included 145 trials that enrolled nearly 50,000 patients. The review found universal shortcomings in study design, leading the researchers to write that they ‘failed to find convincing evidence in support of any mobile phone-based intervention on any outcome.’”

 Microsoft, Cleveland Clinic and Providence join coalition to innovate AI in healthcare: “The Artificial Intelligence Industry Innovation Coalition (AI3C) unites nine other big names alongside Microsoft: the Brookings Institution, Cleveland Clinic, Duke Health, Intermountain Healthcare, Novant Health, Plug and Play, Providence, the University of California, San Diego and the University of Virginia.
Senior executives from each organization on the AI3C board will help co-create new AI tools and follow AI use in the industry, aiming to address the business and socioeconomic barriers that block widespread adoption of the technologies.”

About health technology

 Top 10 Health Technology Hazards for 2022: Annual ECRI report. Top 4:

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
Comment: The list changes every year. Notice 2. and 4. are particularly Covid-related problems.

FDA Reclassifies Apple’s ECG App into Lower-Risk Class II, Special Controls: “Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category.”

 

 

Today's News and Commentary

About Covid-19

Renewal of De​​termination That A Public Health Em​ergency Exists: Xavier Becerra, Secretary of Health and Human Services, renewed the COVID emergency for an additional 90 days (started January 14).

Fourth vaccine dose boosts antibodies, researchers say, but likely not enough to prevent Omicron breakthrough infections: “Early data out of Israel suggests that a fourth dose of either the Pfizer/BioNTech or Moderna coronavirus vaccine can bring an increase in antibodies -- more than what's been seen after a third dose -- but it still might not be enough to protect against breakthrough infections caused by the Omicron variant.
’These are very preliminary results. This is before any publication, but we're giving it out since we understand the urgency of the public to get any information possible about the fourth dose,’ Dr. Gili Regev-Yochay, director of the Infection Prevention and Control Unit at Sheba Medical Center, told reporters during a virtual news conference Monday about the data.”

WHO says no evidence healthy children, adolescents need COVID-19 boosters: “There is no evidence at present that healthy children and adolescents need booster doses of COVID-19 vaccine, the World Health Organization's chief scientist Soumya Swaminathan said on Tuesday.”

Types of Masks and Respirators: An update from the CDC:

  • Clarified that people can choose respirators such as N95s and KN95s, including removing concerns related to supply shortages for N95s

  • Clarified that ‘surgical N95s’ are a specific type of respirator that should be reserved for healthcare settings

  • Clarified that some types of masks and respirators provide more protection to the wearer than others” Specifically, cloth masks should only be used when surgical or N95/K95 masks are not available.

The effect of COVID certificates on vaccine uptake, public health, and the economy: Lessons from the European practice of COVID certificates. The abstract is worth quoting at length:

“We estimate that the announcement of COVID certificates during summer 2021 led to increased vaccine uptake in France of 13.0%… of the total population up to the end of the year, in Germany 6.2%…, and in Italy 9.7%…. Further, this averted an additional 3,979… deaths in France, 1,133… in Germany, and 1,331…in Italy; and prevented gross domestic product (GDP) losses of €6.0… billion in France, €1.4… billion in Germany, and €2.1 …billion in Italy. Notably, the application of COVID certificates substantially reduced the pressure on intensive care units (ICUs) and, in France, prevented occupancy levels being exceeded where prior lockdowns were instated. Varying government communication efforts and restrictions associated with COVID certificates may explain country differences, such as the smaller effect in Germany. Overall, our findings are more sizeable than predicted. This analysis may help inform decisions about when and how to employ COVID certificates to increase vaccine uptake and thus avoid stringent interventions, such as closures, curfews, and lockdowns, with major social and economic consequences.”

24 states must ensure healthcare workers are fully vaccinated by March 15, CMS says: “CMS issued updated guidance Jan. 14 for enforcement of the agency's healthcare worker COVID-19 vaccination mandate, including that covered providers must ensure their employees are fully vaccinated by March 15.”
These 24 states are the ones that challenged the CMS conditions of participation to combat COVID spread.
”CMS said the Supreme Court decision does not affect compliance timelines for providers in the District of Columbia, the U.S. territories and the other 25 states that did not challenge the mandate, which must have their employees fully vaccinated by Feb. 28.”

Association of Race and Neighborhood Disadvantage with Patient Engagement in a Home-Based COVID-19 Remote Monitoring Program: “In a COVID-19 remote patient monitoring program, Black enrollees preferentially selected, and had higher retention in, telephone- over app-based monitoring. As a result, overall retention was similar between races. Remote monitoring programs with multiple modes may reduce barriers to participation.”

U.S. CDC warns against travel to 22 destinations over COVID-19: “In total, the CDC now lists just over 100 countries and territories at "Level 4." The CDC also raised another 20 countries to Level 3: High," including Uganda, Kuwait, Jamaica, Costa Rica and Cuba.”

About health insurance

 MedPAC: Majority of Medicare beneficiaries to be on MA by 2023, but coding issues remain rampant: “MedPAC found 46% of beneficiaries in Parts A and B were enrolled in MA plans, and that figure is expected to stretch past 50% in 2023…
The panel also found that for this year, 99% of Medicare beneficiaries have access to at least one plan, and 98% of them can choose a plan with a Part D benefit.
But MedPAC found that the explosion of growth has not also led to more savings for traditional Medicare.
The panel discovered that this year spending in MA will be 4% higher than fee-for-service Medicare after considering coding practices such as upcoding, which leads to higher quality bonuses for plans…
In 2020, MedPAC found MA risk scores were 9.5% higher than fee-for-service beneficiaries that had a similar health status.”
One factor that must be taken into consideration is that MA plans have a financial incentive to code correctly while traditional Medicare payments are not diagnosis-dependent.

Some insurance brokers enroll people in ACA plans without consent: “Some insurance brokers are enrolling people into Affordable Care Act health plans without their consent, perhaps for the commissions, a move that could put consumers in danger of owing back the subsidies connected with the coverage. The damage could be hundreds or even thousands of dollars.
A consumer's first hint that something is wrong is a big one: a letter from the IRS or a delay in their tax refund.
Although the practice does not appear widespread, it has prompted the Department of Health and Human Services to seek changes to some oversight rules affecting brokers. They would start in 2023.” 

About pharma

 The top 10 biopharma M&A deals in 2021: “Biopharma merger and acquisition (M&A) activity was subdued in 2021, and it would have approached a record low for recent years but for a flurry of deals in the last quarter.  
The top 10 biopharma M&A deals last year reached a combined value of just under $53 billion, well down from the $97 billion tally in 2020 and a fraction of the $207 billion spent on the 10 largest transactions in 2019.”
See the articles for details of the firms involved.  

Teva settles shareholder lawsuit over generic drug pricing for $420 mln: “Teva Pharmaceutical Industries Ltd has agreed to pay $420 million to settle shareholder litigation alleging the company hid an anti-competitive scheme to fix the price of generic drugs.”

Gilead says counterfeiting network sold $250 mln worth of its HIV drugs: “Gilead Sciences Inc said on Tuesday that tampered and counterfeit versions of its HIV treatments worth $250 million were sold to pharmacies over two years by a network of drug distributors and suppliers.”

About the public’s health

 Texas’s six-week abortion ban remains in effect after federal appeals court ruling: “The nation’s most restrictive abortion law remains in effect in Texas after a federal appeals court on Monday rejected a request from abortion providers to immediately return their legal challenge to a trial court judge who had previously blocked the measure.
In a 2-to-1 decision, the U.S. Court of Appeals for the 5th Circuit temporarily transferred the case to the Texas Supreme Court, a step requested by state officials that could leave the dispute in limbo for months.” 

About healthcare IT

 Oscar Health reveals data breach caused by printing error: “The insurer said Friday that it discovered the breach on or around Nov. 23 and believes the incident occurred between Oct. 28  and Nov. 16. The company found that mailers, which contained personal information, were misrouted to other Oscar members.
The mailers included information such as members' names, Oscar ID numbers, claims numbers, provider information, dates of service, procedure names and plan names or affiliations. This information may have been viewed by another Oscar member who received the mailer, according to the notice.”
The article does not say how many members were affected. 

U.S. Department of Veterans Affairs Partners with Google Cloud to Improve Veteran Access to Benefits and Services: “Through a $13 million, multi-year contract, the VA will deploy Apigee, Google Cloud’s application programming interface (API) management platform. The implementation is part of the continued evolution of the VA’s Lighthouse API program, providing developers with seamless and secure access to VA APIs in the development of new tools and services. For example, with Apigee, developers can use the VA’s Benefits API to create applications that help Veterans submit and track electronic benefits claims and add supplemental documentation. Developers can also easily access the VA’s Health APIs to build new online tools that help Veterans manage their health and access their medical records.”

About health technology

The top 10 medtech M&A deals of 2021: “Looking to make up for lost time and hopefully prepare companies for a new life in a post-COVID landscape, dealmaking kept that pace through the first half of 2021 and then some. Logging about $31.5 billion in transactions over the first six months of the year alone, the medtech sector overtook the $28.8 billion M&A total it saw for all of 2020, according to figures from Evaluate Medtech.”
See the article (or link) for details of the firms involved.

 Special Report:
Trust in a New Era of Health: A very interesting report from Salesforce.com. Results are broken down by segment and also age groups. Well worth a least a skim.

Today's News and Commentary

About Covid-19

Biden deploys military medical teams to 6 more 'hard-hit' states, doubles order for free at-home COVID tests: “President Joe Biden announced today the deployment of additional military medical teams to hospitals in six “hard-hit” states alongside plans to procure and ship 500 million more rapid COVID-19 tests for home use.
…President Biden said that more than 800 military and other federal emergency personnel have been deployed across 24 states, tribes and territories to support healthcare providers’ COVID-19 response. Further, more than 14,000 National Guard members have been activated in 49 states…"

COVID-19 Therapeutics for Nonhospitalized Patients: A great and short subject review in today’s JAMA Network.

COVID-19 Testing Chain Opened Pop-Ups Across The US. Now, It’s Temporarily Closing Amid Federal Investigation And Mounting Complaints: “The Center for COVID Control, a locally [Chicago] based chain of testing sites, is under national scrutiny and has been cited at the highest level by a federal agency as reports come in from across the country of chaos at testing sites and confusion over results.
Amid the heightened scrutiny, the center announced Thursday it will close for a week starting Friday…
Again and again, people going to Center for COVID Control sites have reported getting negatives there — only to get a positive elsewhere. Others have never gotten results, or gotten them so late the test was effectively useless. Some people who didn’t even test at the sites were still sent results.”

Florida won't be Biden's 'biomedical police,' DeSantis' office says after Supreme Court ruling: “Florida won’t be enforcing the Biden Administration’s mandatory vaccination policy for health care workers upheld by the U.S. Supreme Court, a spokeswoman for the governor’s office said Thursday.”
The enforcement would be federal if hospitals do not comply with this provision, which is now part of Medicare and Medicaid conditions of participation in those programs.

About health insurance

MedPAC votes on 2023 payment recommendations: “The Medicare Payment Advisory Commission today recommended that Congress provide a current law update for the hospital inpatient and outpatient prospective payment systems in fiscal year 2023, currently estimated at 2.5% for inpatient and 2.0% for outpatient.
In other action, MedPAC recommended that:

  • Congress reduce 2023 payment rates for skilled nursing facilities, home health agencies and inpatient rehabilitation facilities by 5%;

  • Congress update 2023 payment rates for long-term care hospitals by the amount specified in current law;

  • Congress update 2023 Medicare payment rates for physician and other health professional services by the amount specified in current law, and the Department of Health and Human Services require clinicians to use a claims modifier to identify audio-only telehealth services;

  • Congress eliminate the 2023 update to the Medicare conversion factor for ambulatory surgical centers, and the Department of Health and Human Services require ASCs to report cost data; and

  • Congress eliminate the 2023 update to Medicare base payment rates for hospice providers, and the Department of Health and Human Services require hospices to report telehealth services on Medicare claims.”

U.S. Attorney Announces The Arrest Of 13 Individuals For $100 Million Healthcare Fraud, Money Laundering, And Bribery Scheme: “U.S. Attorney Damian Williams said: “The thirteen defendants charged in today’s indictments are alleged to have collectively perpetrated one of the largest no-fault insurance frauds in history. In carrying out their massive scheme, among other methods, they allegedly bribed 911 operators, hospital employees, and others for confidential motor vehicle accident victim information. With this information, they then endangered victims by subjecting them to unnecessary and often painful medical procedures, in order to fraudulently overbill insurance companies. Schemes exploiting no-fault insurance laws – which ironically exist to make insurance more affordable – also result in higher costs, and unfairly burden all consumers in the auto insurance market.”

Boca Lab Owner Admits To $6.9M Medical Testing Scheme: “The owner of a Boca Raton toxicology lab pled guilty in Florida federal court Thursday to billing Medicare for $6. 9 million worth of improperly bundled COVID-19 and genetic testing orders obtained through bribery. Christopher Licata, 45, copped to one count of conspiracy to commit health care fraud and agreed to pay a combined $4. 3 million in forfeiture and restitution. The Delray Beach resident had been scheduled to stand trial next week on the government's April indictment. Licata admitted that between 2018 and 2021, he paid bribes to "patient brokers" Juan Nava Ruiz and Eric Frank, who in turn recruited Medicare beneficiaries. . . “

As omicron surges, HealthCare.gov sign-up deadline arrives: “Health and Human Services Secretary Xavier Becerra said Thursday that about 14.1 million people have enrolled or renewed coverage as of Jan. 8. That’s a gain of roughly 2 million covered through HealthCare.gov and state-run insurance marketplaces. Two GOP-led states — Florida and Texas — are seeing particularly strong sign-ups.”

Justices debate state’s right to take tort recoveries from Medicaid beneficiaries: “Monday’s argument in Gallardo v. Marstiller displayed a bench surprisingly divided over a relatively simple question of statutory interpretation. The topic is what to do when a state Medicaid program pays for injuries that a beneficiary suffers, if the beneficiary later recovers a settlement from a third party that caused the injury. All agree that the state can take the portion of the settlement that addresses past medical expenses. The problem, if the settlement for past medical expenses is not enough to repay the expenses already paid by Medicaid, is whether the state also can take the part of the settlement that reflects future medical expenses.”

HRSA Expands Preventive Care Coverage Under ACA for Women, Children: “The ACA and current HRSA guidelines require certain group health plans to offer coverage for preventive health services with no out-of-pocket costs. The administration has updated these guidelines to include coverage for double electric breast pumps with no co-pay or deductible. The new guidelines also include universal suicide risk screening for adolescents.”

About hospitals and healthcare systems

Factors Associated With Overuse of Health Care Within US Health Systems: “In this cross-sectional analysis, we identified occurrences of 17 low-value services in 3745 hospitals and affiliated outpatient sites. Hospitals were linked to 676 health systems in the US using the Agency for Healthcare Research and Quality (AHRQ) Compendium of Health Systems. The participants were 100% of Medicare beneficiaries with claims from 2016 to 2018.”
”In this cross-sectional study of 676 US health care systems, those that were overusing health care had more beds, had fewer primary care physicians, had more physician practice groups, were more likely to be investor owned, and were less likely to include a major teaching hospital.”

2021 M&A in Review: A New Phase in Healthcare Partnerships: Trends in the data for 2021 include the following:

  • The trend throughout 2021 was a smaller number of transactions being offset with a higher percentage of large transactions. Eight of the announced transactions in 2021 were ‘mega mergers’ (transactions in which the seller or smaller partner by revenue had more than $1 billion in annual revenue). This year had the largest percentage of announced ‘mega merger’ transactions in the last six years at 16.3%, almost double the percentage (8.9%) in 2020.

  • Organizations with high credit quality were the smaller partner in a significant percentage of 2021 announced transactions, in line with 2020 levels and historical peaks. In more than one out of every 10 transactions, the smaller partner had a credit rating of A- or higher in 2021.

  • As previously mentioned, the number of transactions in 2021 was down; however, the average size of smaller partner by annual revenue increased significantly to $619 million, up from $388 million in 2020. Since 2011, average smaller partner size by annual revenue has increased at a compound annual growth rate (CAGR) of approximately 8.0%.

  • Activity by not-for-profit health systems as both acquirer and seller increased as a percentage of total transactions in 2021. Combined, transactions involving a not-for-profit partner represented 87% of announced transactions, compared with 81% in 2020.”

About pharma

Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life: ““Pharma bro” Martin Shkreli was ordered to pay $64.6 million in profits and was banned for life from the pharmaceutical industry for an infamous episode several years ago in which his company purchased an old, lifesaving medicine and then boosted the price by 4,000% overnight.”

Association of Hormonal Contraceptive Use With Adverse Health Outcomes: Recent public health proposals to move oral contraceptives to OTC status could benefit from this study:
”In this umbrella review of 58 meta-analyses of randomized clinical trials and cohort studies describing 156 associations between hormonal contraceptive use and adverse health outcomes among women, no associations with adverse outcomes, including cardiovascular and cancer risk, were supported by high-quality evidence. However, the association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use was graded as having high-quality evidence.”

FDA Warning: Buprenorphine to Treat Opioid Use Disorder Can Cause Dental Problems: The problems include tooth decay; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

About the public’s health

Eliminating the FDA’s blood donation ban on men who have sex with men would help ease the U.S. shortage: A good discussion of the headline’s proposal in the face of the Red Cross’ statement of sever blood shortage. “Studies report no risk to the blood supply in other countries that do not ban donations from this group of men….
UCLA researchers say lifting the ban would mean as many as 350,000 new donors and could treat more than a million people.

About healthcare IT

Talkspace faces securities fraud class-action suit as consumer revenue declines: “The digital health company, which connects patients with licensed therapists or psychiatrists for video or text conversations, has been accused of misleading investors before it went public last year by misrepresenting its financials and growth.
Namely, the class-action suit filed Jan. 7 alleges Talkspace failed to disclose critical growth headwinds, including increased advertising and customer acquisition costs and worsening growth and gross margin trends, and overvalued its accounts receivable from certain health plan clients.”

About healthcare personnel

Military Brass, Judges Among Professions at New Image Lows: “For the 20th straight year, nurses lead Gallup's annual ranking of professions for having high honesty and ethics, eclipsing medical doctors in second place by 14 points -- 81% vs. 67%. Grade-school teachers (64%), pharmacists (63%) and military officers (61%) round out the top five most revered professions in this year's list, with more than six in 10 Americans viewing each as highly ethical.”

About health technology

A good summary of this week’s virtual JPM Conference from FirstWord Pharma:

Spotlight On: The JP Morgan Healthcare Conference – Our key takeaways Part I

Spotlight On: The JP Morgan Healthcare Conference – Our key takeaways Part II

Today's News and Commentary

Consumer Price Index Summary: At 2.5%, medical care had the lowest growth among CPI items for 2021 (unadjusted).

About Covid-19

Supreme Court blocks Biden's Covid requirements for businesses, upholds health care workers mandate: As predicted:
”The Supreme Court on Thursday blocked the Biden administration's rule requiring larger businesses to ensure that workers receive the Covid vaccine or wear masks and get tested on a weekly basis. [Justices Stephen Breyer, Sonia Sotomayor and Elena Kagan dissented].But the court said a separate mandate requiring vaccinations for an estimated 20 million health care workers can be enforced [Justices Clarence Thomas, Samuel Alito, Neil Gorsuch and Amy Coney Barrett dissented].”
See this link for a FAQ from MGMA on the health facility final rule requirements.

BioNTech and AI start-up develop tool to predict high-risk coronavirus variants: “The artificial intelligence-based program, developed by BioNTech, the German biotech group behind the leading Covid-19 vaccine, and north African AI start-up InstaDeep, identified more than 90 per cent of variants of concern, including the highly transmissible Omicron strain, on average two months before their designation by the World Health Organization. The results from the study show that the program can evaluate the risks of new variants from their spike proteins within minutes, and monitor them as they evolve ‘nearly in real time’, according to the two companies. Ugur Sahin, chief executive of BioNTech, said the tool would be made freely available.”
The potential of this tool for preemptive development of vaccines cannot be overstated.

U.S. COVID deaths rising but likely due to Delta, not Omicron, says CDC chief: “COVID-19 hospitalizations in the United States have increased by about 33% and deaths are up by about 40% from a week earlier, the head of the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday…
The recent increase in COVID deaths is likely a lagging effect of the Delta variant, which was surging before Omicron took hold in the United States in December, Walensky said.”

Kids’ low COVID-19 vaccination rates called a ‘gut punch’: ”Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.
As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.
Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.”

Qiagen Gains CE Mark for COVID-19 Test That Measures T-Cell Response: “The assay detects CD4+ and CD8+ T-cell responses, which allows a more comprehensive assessment of immunity generated by COVID-19 vaccines, especially in vulnerable individuals.
T-cell response to the virus declines more slowly than antibody responses and may indicate how severe the course of COVID-19 will be in infected patients.”

Quebec plans to impose a ‘health contribution’ tax on the unvaccinated: “Premier François Legault announced the new ‘contribution’ for the unvaccinated on Tuesday, as the province reported 62 new deaths, bringing the total number of people killed by Covid-19 in the province to 12,028 – the most in Canada.
‘A health contribution will be charged to all adults that don’t want to get vaccinated. We are there now,’ he said. ‘Those who refuse to get the shot bring a financial burden to hospital staff and Quebecers. The 10% of the population can’t burden the 90%.’”

About health insurance

Morgan Health, Kaiser Permanente partner on health equity: “Beginning this month, JPMorgan Chase's some 8,000 California employees will be able to access care through Kaiser Permanente, and the partnership will put a focus on health disparities.
The two plan to jointly collect and report health equity metrics for those patients, Morgan Health executives said at the annual J.P. Morgan Healthcare Conference this week. JPMorgan and Kaiser Permanente plan to roll out performance guarantees tied to health equity on certain quality measures for JPMorgan employees beginning in 2023.”
One needs to ask how Morgan Health is different from a self-insured employer contracting with an existing provider network/ third party administrator.

Clover Health's MA enrollment spikes 25% from 2021: “Clover Health saw its Medicare Advantage enrollment increase 25% in 2022 over the previous year, the insurer said this week.
The startup insurer said that it began January 2022 ahead of its full-year guidance of 82,000 members. The overall industry growth in MA averages 10% year-over-year, according to data from the Kaiser Family Foundation.
Clover offers plans in 209 counties across nine states.”

About pharma

Judge Won't Lift Ch. 11 Injunction For J&J Talc Claims: “A New Jersey bankruptcy judge denied on Tuesday a request to allow a talc claim against Johnson & Johnson to go to trial, saying it would unavoidably disrupt the Chapter 11 case of the company's bankrupt talc spinoff.”

Pfizer to Announce a Record $80 Billion in Revenue Amid Layoffs in Sales Force: “Pfizer is expected to announce record revenue of more than $80 billion for 2021 on robust sales of the COVID-19 vaccine it developed with BioNTech and its oral COVID-19 treatment, Paxlovid, both of which are being sold directly to governments.
This is almost double Pfizer’s total revenue in 2020 of $41.9 billion.”

Drugs to Watch 2022: “This year’s Drugs to WatchTM report identifies seven late-stage experimental treatments that Clarivate analysts forecast to reach blockbuster status within five years, i.e., if approved,
are expected to earn $1 billion in annual revenue. These treatments span a remarkably diverse set of therapeutic areas, from conditions like Alzheimer’s disease (AD) and type 2 diabetes mellitus (T2DM), which afflict tens of millions of patients worldwide, to very rare diseases, such as transthyretin amyloidosis (ATTR), which afflict thousands.”

About the public’s health

Progress on Lung Cancer Drives Overall Decline in U.S. Cancer Deaths: Sharp drops in lung cancer deaths fueled greater declines in overall U.S. cancer deaths from decreases of about 1% a year in the late 1990s to 1.5% a year during the 2000s and 2% a year from 2015 through 2019…”

Secondhand nicotine vaping at home and respiratory symptoms in young adults: “Secondhand nicotine vape exposure was associated with increased risk of bronchitic symptoms and shortness of breath among young adults.”

The real cost of smoking by state: Smoking costs the US more than $300B annually. This list divides the costs by state. At the top is DC, with a total lifetime cost (with the highest contribution from lost income) of >$3.3 million.

About healthcare IT

Headspace Health grabs startup Sayana to build out AI-based mental health tools: “Six months after the $3 billion merger with Ginger, Headspace Health acquired Sayana, an AI-driven mental health and wellness company.
Sayana will expand Headspace Health’s ability to provide personalized self-care content to its 100 million users, executives said.
Headspace Health did not disclose the financial terms of the deal.”

Guidelines and quality criteria for artificial intelligence-based prediction models in healthcare: a scoping review: “This scoping review aimed to identify actionable guidance for those closely involved in AI-based prediction model (AIPM) development, evaluation and implementation including software engineers, data scientists, and healthcare professionals and to identify potential gaps in this guidance…
Topics were extracted from the identified literature and summarized across the six phases at the core of this review: (1) data preparation, (2) AIPM development, (3) AIPM validation, (4) software development, (5) AIPM impact assessment, and (6) AIPM implementation into daily healthcare practice.”

Healthcare finance

HCA, Eli Lilly, Atrium Health back $55M venture fund to invest in Black-founded and -led health startups: “Some heavy hitters in the healthcare and pharma industries—HCA Healthcare, Eli Lilly and the American Hospital Association (AHA)—are backing a new venture fund to invest exclusively in Black-founded and -led healthcare startups.
Nashville, Tennessee-based Jumpstart Health Investors (JHI) raised $55 million for its new Jumpstart Nova venture fund, oversubscribing the initial $30 million goal. The fund will invest exclusively in Black founder-led healthcare companies across health IT, digital health, tech-enabled services, diagnostic devices, biotech, medical device manufacturing and consumer health and wellness, according to a press release.”

Today's News and Commentary

About Covid-19

Estimating COVID-19 Infections, Hospitalizations, and Deaths Following the US Vaccination Campaigns During the Pandemic: “Compared with the no vaccination scenario, the actual vaccination campaign saved an estimated 240 797… lives and prevented an estimated 1 133 617…hospitalizations from December 12, 2020, to June 30, 2021. The number of cases averted during the same period was projected to exceed 14 million.”

U.S. secures 600,000 more doses of GSK-Vir's COVID-19 therapy: Highlights:
—”U.S. deal builds on $1 bln order from November
—About 1.7 mln doses of sotrovimab secured globally
—GSK-Vir bolstering supply, 2 mln doses expected globally in H1”

Assessment of Functional Mobility After COVID-19 in Adults Aged 50 Years or Older in the Canadian Longitudinal Study on Aging: Some good news: “These findings suggest that individuals with mild and moderate COVID-19 who were predominantly not hospitalized experienced deficits in functional mobility compared with those without COVID-19.”

WHO says omicron may infect half of Europe within two months, if current coronavirus trends hold: The headline is the story.

About the public’s health

Red Cross Declares First-ever Blood Crisis amid Omicron Surge: “The American Red Cross is facing a national blood crisis – its worst blood shortage in over a decade, posing a concerning risk to patient care. Amid this crisis, doctors have been forced to make difficult decisions about who receives blood transfusions and who will need to wait until more products become available. Blood and platelet donations are critically needed to help prevent further delays in vital medical treatments.”

Consumption of Olive Oil and Risk of Total and Cause-Specific Mortality Among U.S. Adults: “In substitution analyses, replacing 10 g/d of margarine, butter, mayonnaise, and dairy fat with the equivalent amount of olive oil was associated with 8%-34% lower risk of total and cause-specific mortality. No significant associations were observed when olive oil was compared with other vegetable oils combined.”

About health insurance

State Trends in Employer Premiums and Deductibles, 2010–2020: Highlights from from The Commonwealth Fund study:

  • Premium contributions and deductibles in employer health plans accounted for 11.6 percent of median household income in 2020, up from 9.1 percent a decade earlier.[Emphasis added]

  • In 37 states, premium contributions and deductibles amounted to 10 percent or more of median income in 2020, up from 10 states in 2010.

  • Middle-income workers in Mississippi and New Mexico faced the highest potential costs relative to income, 19 percent and 18 percent, respectively.

  • The total cost of premiums plus potential spending on deductibles ranged from a low of $6,528 in Hawaii to a high of more than $9,000 in Florida, Kansas, Missouri, South Dakota, and Texas.”

CVS Health boosts 2021 guidance on back of stronger than expected retail performance in Q4: “CVS Health boosted its 2021 guidance Tuesday ahead of its fourth-quarter earnings in early February, with executives citing better-than-expected performance in its retail segment.
In a filing with the Securities and Exchange Commission, the healthcare giant raised its full-year earnings projections to between $8.33 and $8.38 per share from a previous estimate of $8. The company also affirmed its 2022 guidance range of between $8.10 and $8.30 per share.”

Labor Department demands insurers stop flouting ACA's birth control rules: “The Biden administration is reminding insurers they must fully cover contraceptive coverage after complaints of some payers denying claims for certain products.
The Department of Labor released an updated frequently asked questions document on Monday that outlined requirements for insurers to cover at-home COVID-19 tests. Tucked into the document is a stern reminder of insurers’ requirements under the Affordable Care Act.”

UnitedHealthcare settles class-action underpayment suit for $10M: “The U.S. District Court for the Eastern District of New York approved a $10 million final settlement for a class-action lawsuit targeting UnitedHealthcare and its tiered reimbursement policy.
The lawsuit, filed in 2017, claims that UnitedHealthcare's policy reduced payments for out-of-network mental healthcare providers — including psychologists, counselors and social workers — by between 25 percent and 35 percent…”

6 payers recognized for stakeholder commitment, 3 rank in top 100: “Six payers were recognized by nonprofit JUST Capital for their commitment to stakeholder responsibility, with three ranking among the top 100 U.S. companies.
In tandem with CNBC, the nonprofit released its "2022 Rankings of America’s Most JUST Companies" on Jan. 10, which orders companies based on their success across five stakeholder metrics — investing in its employees, supporting communities, prioritizing good governance, customer service, and environmental impact.”
Anthem is highest among payers at #16 among all companies.

About pharma

Pfizer locks in 2 partners to solidify status as mRNA powerhouse: “In the first deal… Pfizer has secured access to Acuitas Therapeutics’ lipid nanoparticle delivery system for use in mRNA vaccines and therapeutics. The nonexclusive development and option agreement covers up to 10 targets that could someday become vaccines or therapeutic programs. Financial terms of the agreement were not disclosed.
Lipid nanoparticles are critical to protecting mRNA—which provides a set of instructions for cells to, for example, fight a virus—until it arrives at the target in the body. This technology was used in both authorized mRNA COVID-19 vaccines, with Acuitas’ proprietary delivery system specifically tapped for the Pfizer-BioNTech shot.
In the second deal, Pfizer will offer milestone payments “in excess” of $100 million to Codex DNA for access to the biotech’s novel enzymatic DNA synthesis technology. This will similarly be used to develop new mRNA vaccines and therapeutics. The financial terms, which were not spelled out, include an upfront payment and the milestones, which Codex said “could be earned in the near term.”
Codex has developed a system called short oligo ligation assembly (SOLA) EDS technology, which provides a scalable, efficient and cost-effective approach to research. SOLA EDS can construct synthetic DNA, RNA and proteins, which can be used to develop new mRNA-based medicines and vaccines.”

Sanofi makes $75M preclinical bet to join Roche, Novartis and more in congested Parkinson's field: “Add Sanofi to the list of companies aiming to treat Parkinson’s disease by targeting alpha-synuclein. The Big Pharma has claimed a spot toward the back of the pack by paying $75 million upfront for the global rights to a preclinical bispecific that targets the protein.
Sanofi is picking up the rights to the drug, which is currently called ABL301, from South Korea’s ABL Bio in return for the upfront fee and the promise of up to $985 million in milestones. ABL landed the deal after generating preclinical evidence that ABL301 crosses the blood-brain barrier (BBB) more efficiently than a monoclonal antibody and reduces brain aggregated alpha-synuclein.”

PIPELINE INSIGHTS REPORT DRUGS TO WATCH: This Optum report looks at three upcoming drugs to watch in 2022.

About healthcare IT

ONC adds guidelines for e-prescribing, public health reporting: “The Office of the National Coordinator for Health Information Technology updated its Interoperability Standards Advisory to include specifications for e-prescribing and public health reporting.
In a Jan. 11 blog post, the ONC said it has added the National Council for Prescription Drug Programs' Real-Time Prescriptions Benefit Standard Version 12. This addition will help communication efforts between pharmacy benefit payers and prescriber systems.”

Digital Health Startup Transcarent Just Raised $200 Million To Grow Its Concierge Medical Business: “Its customers, which are large-scale employers that self-insure for health coverage, are provided with a concierge medicine-like experience through its digital app, which enables users to connect with a doctor either through text or video call 24 hours a day. For more serious issues, the company will arrange a second opinion and then determine the best doctor and/or hospital to treat the patient. What’s more, those employees who use the service never have to pay premiums, co-pays or other bills.”

About healthcare personnel

Glassdoor: Best places to work in healthcare for 2022: “Glassdoor released its list of "Best Places to Work" in 2022, and four hospitals and health systems made the list. 
Several healthcare, pharmaceutical and medical device companies also were named to the list of 100 companies.”

About healthcare systems

DaVita, Fresenius Accused of Putting Minority Patients at Risk: “Kidney dialysis centers in California are being accused of discriminating against Latino and Asian American patients by subjecting them to unsafe and potentially lethal treatments at disproportionately higher rates in a complaint filed Tuesday with the U.S. Department of Health and Human Services’ Office for Civil Rights.
The Service Employees International Union-United Healthcare Workers West, the National Health Law Program and five dialysis patients say Latino and Asian American patients at centers run by DaVita Inc. and Fresenius Medical Care North America Inc. are being disproportionately exposed to hemodialysis treatments at dangerously higher speeds than white patients….
Latino and Asian American patients are being exposed to these treatments at high speeds at a rate approximately 50% greater than white patients, the complaint alleges.”

Today's News and Commentary

About Covid-19

Insurers must cover at-home COVID-19 tests starting Jan. 15 under new CMS directive: “Insurers must cover at least eight at-home COVID-19 tests per covered individual starting on Saturday, per a new directive from the Biden Administration.
The frequently-asked questions document released by the Centers for Medicare & Medicaid Services (CMS) is an effort to improve access to at-home tests, which have been in short supply in recent weeks amid a surge of the virus fueled by the omicron variant.”

Assessing changes to N95 respirator filtration efficiency, qualitative and quantitative fit, and seal check with repeated vaporized hydrogen peroxide (VHP) decontamination: “Highlights:

N95 respirators were decontaminated with vaporous hydrogen peroxide 25 times.

No alterations to respiratory integrity or filtration efficiency seen by 25 cycles.

Vaporous hydrogen peroxide does not appear to impact fit or filtration efficiency using this defined process.

Merck Delivered 900,000 Antiviral Courses to U.S. Last Month: “Merck & Co. delivered 900,000 courses of its Covid-19 antiviral pill to the U.S. in December and is set to provide 3 million courses ordered by the government by the end of January, Chief Executive Officer Rob Davis said.
Despite the supply-chain issues that have plagued companies around the world, Davis said Merck was able to make 10 million courses of the drug, molnupiravir, as expected last year. They just need to be labeled and shipped, he said.”

Biden coronavirus vaccine-or-test mandate goes into effect: “Key components of the Biden administration’s COVID-19 vaccine or test mandate for more than 80 million workers went into effect Monday amid an ongoing Supreme Court battle that could ultimately doom the rule.   
The months-long legal battle over the requirement, which was previously blocked by a federal court before being reinstated, has created confusion among employers about how to move forward. While Supreme Court justices expressed skepticism about the rule on Friday, they did not block its implementation by Monday’s deadline.  
As of Monday, businesses with 100 or more employees were required to have a database of their workers’ vaccination status, post their company vaccine policy, provide paid leave to workers getting the vaccine and require unvaccinated employees to wear a mask at work.  
The Occupational Safety and Health Administration (OSHA), the agency tasked with enforcing the rule, has said it won’t issue penalties for noncompliance until Feb. 9.”

Usability of COVID-19 Antigen Home Test Kits: “Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability.” 
Good review.

HHS head defends CDC director: 'She doesn't have a degree in marketing': “[HHS Secretary] Becerra defended the leader, saying, ‘Dr. Rochelle Walensky is an infectious disease expert. She has a medical license and she also has a degree in public health. She doesn't have a degree in marketing.’ He then said, ‘Who do I want running CDC? Someone who knows infectious diseases, someone who understands this stuff. And so, while we may have issues with some of the marketing that's been done, I guarantee you, Dr. Walensky is someone we need at CDC.’”
Where is the communications director???

Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19: Highlights from this first-in-class product:
—”Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction over eight days

—The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or death showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo

—A total of 407 patients were recruited in the Phase 2 study and ensovibep was safe and well-tolerated at all doses (75mg, 225mg and 600mg) – with 75mg the planned dose for further development

—Ensovibep continues to maintain potent in vitro pan-variant activity against all variants of concern identified so far, including Omicron

—Ensovibep is a multi-specific DARPin (Designed Ankyrin Repeat Protein), specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein through highly potent and cooperative binding, making it challenging for escape mutants”

A market-based solution to the anti-vaxxer problem: From The Financial Times: “As the world grapples with the fast-spreading Omicron variant and its potentially devastating consequences, a major policy dilemma revolves around how governments might nudge the unvaccinated or partially vaccinated to join the ranks of those who are fully protected. Policies proposed range from fines (in Greece), and Covid passes to access public venues (in France and Switzerland), to nationwide mandatory vaccination (in Austria). Vaccination mandates in particular rankle liberals and libertarians alike and raise challenging ethical questions, while arguably entrenching the position of the unvaccinated…
One way to nudge the unvaccinated to get a jab is to require that those who remain unvaccinated by choice pay for the cost of their own medical care, in case of Covid-induced hospitalisation — a policy that Singapore introduced last year. Some will argue that such a requirement would hit the less well-off or ethnic minorities, who are disproportionally unvaccinated, while giving a free pass to wealthier individuals. To counter that, I would propose a charge philosophically similar to that applied to speeding fines: as a percentage of (in this case annual) income.”

About pharma

Medicare proposes covering expensive drug for early-stage Alzheimer’s, but with restrictions that will sharply limit use: “Medicare officials announced Tuesday they would cover a controversial Alzheimer’s drug — but only with restrictions that will sharply limit who receives the drug.
The Centers for Medicare and Medicaid Services proposed a national policy that would cover Aduhelm and similar drugs in development only for people enrolled in qualifying clinical trials.
The proposal is open to public comment for 30 days. The agency has said it plans to issue a final decision in April.”

114 drugs currently in shortage, per FDA: “Nationwide, more than 100 drugs are in short supply, including antibiotics, diuretics, opioids and heart failure medications, FDA data shows.
As of Jan. 11, 114 drugs were in shortage, according to the FDA's database of current and resolved drug shortages, which is updated daily. The current tally is a continuation of shortage levels seen last year. In November 2021, the FDA reported 112 drug shortages.”

Judge Allows Sacklers to Appeal Ruling on $4.5 Billion Opioid Settlement: “A federal judge is allowing the Sackler family and their company Purdue Pharma to appeal a ruling that overturned a $4.5 billion settlement resolving thousands of complaints alleging they helped fuel the opioid epidemic.”

Researchers find hormone in fat tissue that could help insulin-resistant patients with diabetes: “Insulin has been the primary way of treating diabetes and other high blood sugar conditions for nearly a century. Now, researchers say a molecule made in fat tissue could pave the way for new diabetes therapies and spark new metabolism research. 
The discovery is FGF1, a hormone that regulates blood glucose by inhibiting the breakdown of fat, a metabolic process known as lipolysis. Insulin and FGF1 both inhibit lipolysis, but the hormones operate differently, which could lead to safe and successful lowering of blood glucose in people who are resistant to insulin, researchers at Salk Institute reported in Cell Metabolism this month.
The researchers found that the two diverge in similarity when it comes to signaling pathways. Insulin tamps down on fat breakdown through PDE3B, whereas FGF1 uses the pathway known as PDE4…
The PDE4 pathway can lead to new drug discovery and basic research focused around high blood glucose and resistance to insulin…”

About health insurance

Humana execs try to soothe skittish investors as new MA enrollment projections disappoint: “The insurer issued a filing with the Securities and Exchange Commission on Thursday that decreased its outlook for MA enrollment from between 325,000 and 375,000 new members to between 150,000 and 200,000 new members. 
Humana added 130,000 members during the annual enrollment period for MA last fall. It said in the filing that it saw higher than expected terminations during the enrollment window and expects an elevated number of terminations through 2022.”

Centene execs tout strong MA enrollment period—though work remains on star scores: “The merger between Centene and WellCare Health Plans created the country's largest sponsor of government insurance, with a massive reach in the Affordable Care Act's exchanges, Medicare and Medicaid.
The company has also invested heavily in rebranding its disparate MA plans to align them across the portfolio and has brought on new ambassadors for outreach to seniors. Even prior to the merger, Centene was working on its digital distribution channels to improve the experience…
[T]he company is working on improving its star ratings. More than half of its members selected a four-star or higher plan for 2022.”

HHS: Nearly 14M people enroll on ACA's exchanges ahead of Jan. 15 deadline: “More than 13.8 million consumers have signed up for 2022 healthcare coverage on HealthCare.gov and state-run marketplaces, according to the latest federal figures.
The Department of Health and Human Services (HHS) delivered the latest sign-up numbers ahead of the Jan. 15 open enrollment deadline. The agency touted enhanced subsidies that are set to expire after this year as a key driver of the growth.”

In an unprecedented move, HHS asks officials to consider lowering this year’s Medicare premiums: “The nation’s top health official Monday directed Medicare to consider lowering the premium for the part of the program that covers visits to the doctor and other care outside hospitals. It marked the first time the vast federal health insurance system for older Americans and those with disabilities has rethought the monthly amount patients pay after a change has gone into effect.
Health and Human Services Secretary Xavier Becerra gave the instructions to the Centers for Medicare and Medicare Services (CMS), the agency that oversees the program, saying a review of the Part B premium is needed because of a price drop in a controversial Alzheimer’s drug that Medicare does not yet pay for but might begin covering soon.”

Gavin Newsom proposes health care access for all in plan to cover undocumented Californians: “Gov. Gavin Newsom is proposing to extend Medi-Cal coverage to all low-income, undocumented adults, a historic expansion that would make California the first state in the nation to provide universal health care access for all residents regardless of legal status. The plan is included in Newsom’s $286 billion state budget proposal, which is flush with a projected $45.7 billion surplus. Coverage would begin on Jan. 1, 2024 and would cost the state an ongoing $2.7 billion annually. The program’s launch in the 2023-24 fiscal year is expected to cost $819.3 million.”
In a related article: Single-Payer Healthcare Makes a California Comeback: This article is an editorial opinion by The Wall Street Journal. Well worth getting access to read, as it breaks down the costs of the proposal. With many high tech companies leaving the state, this measure may accelerate business flight.

About healthcare IT

HHS issues warning for healthcare ransomware threats: “The Department of Health and Human Services' Health Sector Cybersecurity Coordinator Center warned the healthcare sector about a cybercrime group targeting the industry.
In a Jan. 6 alert, the department detailed that financially-motivated cybercrime group Mespinoza is increasing its capabilities to target more frequently.
The group has developed its own ransomware variant, known as PYSA, that can encrypt victims' files.”

Loyola email breach exposes nearly 17,000 patients' info: Loyola University Medical Center in Chicago, a part of Trinity Health, recently notified patients of an October data breach that exposed patients' protected health information…
The exposed information included patients' full names, addresses, phone numbers, dates of birth, email addresses, medical record numbers, conditions, medications, test results, medical facilities, types of service and some health plan information.”

About hospitals and health systems

Staffing expenses led to an extra $440M in operating costs in 2021 for AdventHealth: “Major disruptions in the healthcare labor market cost hospital system AdventHealth an additional $440 million in operating costs last year.”

About healthcare personnel

Best Health Care Jobs: From US News. #1 is nurse practitioner.

About the public’s health

Prevalence and Predictors of Young-Onset Colorectal Neoplasia [CRC]: Insights from a Nationally Representative Colonoscopy Registry: “Increasing age, male sex, white race, family history of CRC, and examinations for bleeding or screening were all associated with higher odds of advanced premalignant lesions (APLs) and CRC. Among patients aged 45-49, 32% had any neoplasia, 7.5% had APLs, and 0.58% had CRC. Rates were almost as high in those aged 40-44. Family history of CRC portended neoplasia rates 5 years earlier. Rates of APLs were higher in Asians and American Indian/Alaskan Natives, but lower among Blacks and Hispanics, compared to white counterparts. The prevalence of any neoplasia and APL gradually increased between 2014-2020, in all age groups.
These data provide support for lowering the screening age to 45 for all average risk individuals.[Emphasis added] Early messaging to patients and providers in the years leading up to age 45 is warranted, especially in those with a family history of CRC.”

About healthcare technology

Medtronic to Acquire Affera: “Medtronic… announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company…”
The price of the acquisition, expected to close in 2023, is $925 million.

Today's News and Commentary

About Covid-19

Coronavirus in the U.S.: Latest Map and Case Count: Latest data from The NY Times. Among the findings:
”With the Omicron variant spreading rapidly, the country is averaging more than 500,000 new cases a day, far more than at any previous point in the pandemic. Omicron appears to cause less severe illness than prior forms of the virus, but has contributed to upticks in hospitalizations…
Hospitalizations have increased more than 50 percent over the last two weeks, a steep incline but so far a much lower rate of increase than cases. More than 100,000 coronavirus patients are hospitalized nationwide. Deaths, which are a lagging indicator of virus activity, have not yet increased.”

FDA shortens timing of Moderna booster to 5 months: “U.S. regulators on Friday shortened the time that people who received Moderna’s COVID-19 vaccine have to wait for a booster — to five months rather than six.
The two-dose Moderna vaccine is open to Americans 18 and older. The Food and Drug Administration’s decision Friday means Moderna recipients are eligible for a booster after at least five months have passed since their last shot. The Centers for Disease Control and Prevention agreed.
That’s in line with new recommendations for recipients of the Pfizer vaccine. Initial Pfizer vaccinations are open to anyone 5 or older. But only Pfizer recipients 12 and older are eligible for boosters, and earlier this week U.S. health authorities said they can get one five months after their last shot.”

U.S. sends states monoclonal antibodies that may not work against omicron: “David Kessler, the chief scientific officer for the administration’s covid response, said the government has been responding to requests from state and local health officials in making all three monoclonal antibodies available. But the administration has made clear that the two that don’t work against the omicron variant should be used ‘only if the delta variant represents a significant proportion of infections in the region and then only with the explicit understanding that these treatments would be ineffective if the patients are infected with the omicron variant.’”

Vaccinated Women Pass COVID-19 Antibodies to Breastfeeding Babies: “Women vaccinated against COVID-19 transfer SARS-CoV-2 antibodies to their breastfed infants, potentially giving their babies passive immunity against the coronavirus, according to University of Massachusetts Amherst research.
The study, published in the journal Obstetrics & Gynecology, measured the immune response to the COVID-19 mRNA vaccine in both breast milk and the stools of breastfed infants.”

A guide to COVID tests: When to test, what kind to use and what your results mean: A good review from NPR.

Association of a Third Dose of BNT162b2 Vaccine With Incidence of SARS-CoV-2 Infection Among Health Care Workers in Israel: “In this cohort study of 1928 health care workers in Israel who were previously vaccinated with a 2-dose series of BNT162b2 [Pfizer/BioN Tech], administration of a booster dose compared with not receiving one was significantly associated with lower risk of SARS-CoV-2 infection during a median of 39 days of follow-up (adjusted hazard ratio, 0.07).”

Pfizer CEO says omicron vaccine will be ready in March: “Pfizer CEO Albert Bourla said an omicron vaccine will be ready in March, and the company is already manufacturing doses.
Bourla said the goal is to produce a vaccine that is much better at preventing infection from omicron.”

About healthcare IT

Teladoc projects $2.03B in 2021 revenue, up from previous guidance, after stock plummeted last year: “Teladoc expects its full-year 2021 revenue to hit $2.03 billion, up from previous guidance of $2.015 billion to $2.025 billion, nearly doubling its 2020 revenue.
The telehealth provider estimates it delivered more than 14.7 million virtual visits in 2021, up from 10.6 million visits in 2020. The company also anticipates between $260 million and $265 million in full-year adjusted EBITDA.
For 2022, Teladoc is projecting full-year revenue of around $2.6 billion.
Despite the company’s strong financial performance, Teladoc’s shares plummeted 54% in 2021, compared to the S&P 500’s strong gain of approximately 27%. The telehealth giant isn’t yet profitable…”

R1 RCM to Acquire Cloudmed, Creating the Strategic Revenue Partner for Healthcare Providers: “R1 RCM Inc. (“R1”), a leading provider of technology-driven solutions that transform the patient experience and financial performance of healthcare providers, today announced that it has entered into a definitive agreement to acquire Cloudmed, a leader in Revenue Intelligence™ solutions for healthcare providers, in an all-stock transaction. The transaction values Cloudmed at approximately $4.1 billion, including $857 million of net debt, based on R1’s closing stock price on January 7, 2022.”

ONC releases data standard for patient addresses: 4 things to know: “The Office of the National Coordinator for Health Information Technology on Jan. 7 issued Version 1.0 of Project US@, its healthcare specification for representing patient addresses to improve patient matching.”

Microsoft warns of continued Log4j exploitation attempts: “Microsoft urges companies to remain vigilant and use scanning systems to detect unusual activity as Log4j's continued exploitation attempts occur.
Microsoft warned organizations in a Jan. 3 blog post that the attempts against Log4j, a highly-utilized open-source code, are extremely threatening and could pose security risks to the healthcare sector.“

About hospitals and health systems

19% of US hospitals critically understaffed, 21% anticipate shortages: An update of a previous post: “Just over 19 percent — or 1,168 of 6,089 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 9.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.
Meanwhile, more than 21 percent — or 1,287 of 6,089 — of all hospitals in the U.S. are anticipating shortages in the next week.”

About health insurance

New Hampshire reaches $21.1 million settlement with Centene: “New Hampshire has reached a $21.1 million settlement with a Missouri company over the inaccurate reporting of pharmacy benefit services cost, the attorney general's office said Friday…
In recent months, the company has settled with several other states following a two-year investigation into whether the firm had overcharged Medicaid for prescriptions. Kansas in December reached a $27.6 million settlement and Mississippi and Ohio in June settled lawsuits against Centene for a total of nearly $144 million.”

About the public’s health

Association of Cigarette Sales With Comprehensive Menthol Flavor Ban in Massachusetts: “The comprehensive flavor ban in Massachusetts was associated with a statistically significant decrease in state-level menthol and all cigarette sales…
Nonflavored cigarette sales in Massachusetts vs the comparison states increased after the ban, suggesting the potential substitution of nonflavored cigarettes for menthol cigarettes.”

U.S. emissions surged in 2021, putting the nation further off track from its climate targets: “A 17 percent surge in coal-fired electricity helped drive an overall increase of 6.2 percent in greenhouse gas emissions compared with the previous year, according to an analysis published Monday by the Rhodium Group. While emissions remained below pre-pandemic levels, it marked the first annual increase in reliance on the nation’s dirtiest fossil fuel since 2014, the independent research firm said.”

10 Percent of U.S. Adults Meet Vegetable Intake Recommendations: “Only 12.3 and 10.0 percent of U.S. adults met the fruit and vegetable intake recommendations, respectively, in 2019, according to research published in the Jan. 7 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report
The researchers found that 12.3 and 10.0 percent of adults met fruit and vegetable recommendations, respectively, ranging from 8.4 to 16.1 percent in West Virginia and Connecticut and from 5.6 to 16.0 percent in Kentucky and Vermont, respectively.”

About pharma

Pfizer pays Beam $300 million upfront as part of base editing deal: “Pfizer entered into a four-year research deal with Beam Therapeutics potentially worth over $1.3 billion focused on in vivo base editing programmes for three targets for rare genetic diseases of the liver, muscle and central nervous system, the companies announced Monday…
The three programmes will leverage Beam's in vivo delivery technologies, which use mRNA and lipid nanoparticles (LNP) to deliver base editors to target organs. Under the agreed terms, Beam will conduct all research activities through development candidate selection. Pfizer will then be able to option exclusive, worldwide licenses to each of them, at which point it will take on all development activities.”

23andMe Initiates Phase 1 Clinical Trial for First Wholly-Owned Immuno-oncology Antibody for Patients with Solid Tumors: The headline is the story.
And in a related story: 23andMe snags 3rd FDA nod for cancer risk test, this time for prostate cancer

New York Plans to Install ‘Vending Machines’ With Anti-Overdose Drugs: “New York City health officials have announced a plan to install 10 “public health vending machines” that would dispense sterile syringes, an anti-overdose medication and other “harm reduction” supplies to help neighborhoods that have been hit hard by drug overdoses.”

JPM22, Day 1: The annual JP Morgan Healthcare Conference is being held virtually. “Fierce Pharma will be covering the day's biggest news at it happens. Check back here for updates, and catch Fierce Biotech's coverage here.” Among the announcements: New Johnson & Johnson CEO Duato points out 5 pipeline meds that can generate $5B+: “Among the healthcare giant's pipeline, Duato highlighted five programs that could generate $5 billion or more in peak sales. Those are the Legend Biotech-partnered CAR-T medicine Carvykti, the potential “pipeline in a product” drug nipocalimab, Rybrevant in lung cancer, a potential first-in-class oral Factor XIa inhibitor milvexian and a potential bladder cancer platform called Taris.”

About healthcare technology

In a First, Man Receives a Heart From a Genetically Altered Pig: “A 57-year-old man with life-threatening heart disease has received a heart from a genetically modified pig, a groundbreaking procedure that offers hope to hundreds of thousands of patients with failing organs.
It is the first successful transplant of a pig’s heart into a human being. The eight-hour operation took place in Baltimore on Friday, and the patient, David Bennett Sr. of Maryland, was doing well on Monday, according to surgeons at the University of Maryland Medical Center.”

Fierce Healthcare's Fierce 15 of 2022: “Virtual care, home health and health equity remain key trending topics within healthcare. Our list touches on those in a number of ways, including platforms to address the social determinants of health, ways to treat behavioral health needs digitally, and offer better care in the home.” The article has links to each of the 15 winners.

Today's News and Commentary

About Covid-19

Supreme Court hears challenges to Biden’s vaccine rules for workers: The Court heard two cases today. The first concerned whether OSHA has regulatory authority to impose COVID regulations in the workplace. Given the questioning, it seems likely the Court will reject this authority.
The second case centered on CMS’s ability to require COVID precautions as a condition of participation in federal health programs (Medicare and Medicaid). The argument was that the federal government has the right (and responsibility) to assure safety of beneficiaries for whom it is paying. The justices seems to be inclined to accept CMS’s right to require precautions; however, the basis for such a decision may narrowly focus on the standing of the states that brought the suit (as occurred with the last decision to uphold the ACA).
Throughout the proceedings, the conservative justices raised questions about why COVID was different from past infectious diseases (like the flu) that made the above measures necessary. No one brought up the healthcare state of emergency that the HHS Secretary has renewed during the pandemic.

WHO: Record weekly jump in COVID-19 cases but fewer deaths: “The World Health Organization said Thursday that a record 9.5 million COVID-19 cases were tallied over the last week as the omicron variant of the coronavirus swept the planet, a 71% increase from the previous 7-day period… However, the number of weekly recorded deaths declined.”

False-Positive Results in Rapid Antigen Tests for SARS-CoV-2: “There were 903 408 rapid antigen tests conducted over 537 workplaces, with 1322 positive results (0.15%), of which 1103 had PCR information. Approximately two-thirds of screens were trackable with a lot number. The number of false-positive results was 462 (0.05% of screens and 42% of positive test results with PCR information). Of these, 278 false-positive results (60%) occurred in 2 workplaces 675 km apart run by different companies between September 25 and October 8, 2021. All of the false-positive test results from these 2 workplaces were drawn from a single batch of Abbott’s Panbio COVID-19 Ag Rapid Test Device.”

COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting: A few highlights:
—”Hospitals are responsible for reporting the information to the Federal government. Facilities should report at the individual hospital level, even if hospitals share a Centers for Medicare & Medicaid Services (CMS) Certification Number (CCN).
We recognize that some health care systems choose to report for all facilities in their network from a central corporate location.We also recognize that many states currently collect this information from the hospitals. Therefore, hospitals may be relieved from reporting directly to the Federal government if they receive a written release from the state indicating that the state is certified and will collect the data from the hospitals and take over the hospital’s Federal reporting responsibilities…
—Hospitals, with the exception of psychiatric and rehabilitation hospitals are required to report seven days a week but, where possible and pending further direction from their state or jurisdiction, are encouraged to report weekend data on the following Monday with the data backdated to the appropriate date. Psychiatric hospitals and rehabilitation hospitals report once weekly on Wednesday.”
—The document provides the several accepted methods for reporting the data.

FDA must hit the gas on FOIA request tied to Pfizer's COVID-19 vaccine, judge orders: “Rather than 75 years, it will now take about eight months for the FDA to make public the information it used to license Pfizer and BioNTech’s COVID-19 vaccine—provided the regulator can keep up with the new schedule.
U.S. district judge Mark Pittman on Thursday ordered the FDA to produce all remaining data on the vaccine at a rate of 55,000 pages per month, much faster than the 500-page-per month quota the FDA proposed in November.”

West Virginia seeks permission to offer 4th vaccine dose: “West Virginia is seeking permission from the federal government to offer a fourth COVID-19 vaccine dose to at-risk people, making it the first state to do so. West Virginia Gov. Jim Justice sent a letter to the Biden administration requesting the FDA and CDC authorize the state to offer a second booster to people 50 and older and essential workers at least three months after receiving their first booster, according to Jan. 6 news release.“

Responding to Omicron: Aggressively Increasing Booster Vaccinations Now Could Prevent Many Hospitalizations and Deaths: From the Commonwealth Fund:
”According to the model, at the current pace of booster vaccination, during the next four months COVID-19 will cause an additional 210,000 deaths, nearly 1.7 million hospitalizations, and almost 110 million additional infections. Immediately doubling the December pace of boosters to 1.5 million per day could prevent approximately 41,000 deaths and more than 400,000 hospitalizations by the end of April and avert more than 14 million infections. Tripling the daily rate to 2.3 million per day could prevent more than 63,000 deaths and nearly 600,000 hospitalizations, while preventing more than 21 million infections.”

Insurers, Employers Urge Price Caps on ‘Free’ Home Covid Tests: “Federal health officials are expected to release guidance this month outlining how private health plans must reimburse their beneficiaries for the cost of at-home Covid tests. The policy is key to the administration’s effort to tamp down the spread of the virus, now occurring at historic levels…
The concern for consumer advocates is that some retailers or even diagnostic companies will raise the cost of the tests once they know insurers are footing the bill.
‘If insurers have to reimburse for at-home tests from anywhere at any price, they will be at the mercy of price gouging by unscrupulous sellers,’ Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said. ‘If insurers are left holding the bag, consumers will be shielded in part from price gouging, but they still face risks.’”

Risk Factors for Severe COVID-19 Outcomes Among Persons Aged ≥18 Years Who Completed a Primary COVID-19 Vaccination Series — 465 Health Care Facilities, United States, December 2020–October 2021:
From the CDC:
”Among 1,228,664 persons who completed primary vaccination during December 2020–October 2021, severe COVID-19–associated outcomes (0.015%) or death (0.0033%) were rare. Risk factors for severe outcomes included age ≥65 years, immunosuppressed, and six other underlying conditions. All persons with severe outcomes had at least one risk factor; 78% of persons who died had at least four.”

About hospitals and health systems

Hospitals lose 5,100 jobs in December: “Hospitals lost jobs in December for the second straight month, according to the latest jobs report from the U.S. Bureau of Labor Statistics.
Hospitals lost 5,100 jobs in December, compared with 3,900 lost in November. Hospitals gained 1,100 jobs in October and lost 8,100 jobs in September.”
And in a related article: More than 19% of US hospitals are critically understaffed: Numbers by state: “Just over 19 percent — or 1,167 of 6,051 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 6.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.”
Rates range from 53% in Vermont to 0% in DC.

About pharma

States Oppose Purdue's 2nd Circ. Appeal Try In Ch. 11 Case: “Numerous states filed briefs Thursday in New York federal court opposing the request by bankrupt drugmaker Purdue Pharma to appeal the unraveling of its Chapter 11 plan to the Second Circuit, arguing that the appeal would further delay resolution of the case.”

Walgreens Posts Higher Sales and Profit From Covid-19 Demand: “Walgreens Boots Alliance Inc. rode the latest Covid-19 surge to its highest retail sales increase in 20 years, but Americans’ scramble for vaccines and tests has overwhelmed workers and dented growth in prescriptions…
Covid-19-related demand took a toll on other parts of the business, Walgreens said. Prescription sales, not including vaccines, grew 1.8%, as staffing shortages prompted some stores to close early and prevented pharmacists from calling patients to ensure they are keeping up on their medications.”

Merck leans into AI with $610M in biobucks for Absci drug discovery pact: “Merck is taking a deep dive into complex proteins with the help of artificial-intelligence-powered drug discovery company Absci. The two companies have signed a research collaboration for up to three targets in a deal worth up to $610 million in upfront fees and milestone payments. 
Merck will use Absci’s Integrated Drug Creation platform, which uses AI and synthetic biology to find new drug targets and match them up with potential medicines. The company also generates cell lines to manufacture the therapeutic candidates, all in one process.”

Merck KGaA to acquire Exelead for $780 million: “Merck KGaA said Thursday that it is acquiring biopharmaceutical contract development and manufacturing organisation (CDMO) Exelead for about $780 million in cash. The German drugmaker noted that Exelead specialises in complex injectable formulations, including lipid nanoparticle (LNP)-based drug delivery that is a key component in mRNA therapeutics.”
Note: Merck KGaA is a different company from Merck mentioned above.

About health insurance

CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P): “This proposed rule would revise the MA and Part D regulations related to marketing and communications, the criteria used to review applications for new or expanded MA and Part D plans, quality ratings for MA and Part D plans, provider network adequacy requirements, medical loss ratio reporting, special requirements during disasters or public emergencies, and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This proposed rule would also revise regulations for D-SNPs, and in some cases other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many proposals are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.”
A few highlights:
—”CMS is proposing a policy that would require Part D plans to apply all price concessions they receive from network pharmacies to the point of sale, so that the beneficiary can also share in the savings. Specifically, CMS is proposing to redefine the negotiated price as the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023. This policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition in the Part D program…
—Current regulations have special requirements for MA plans during disasters or emergencies, including requirements for plans to cover services provided by non-contracted providers and to waive gatekeeper referral requirements. The proposal would require a MA plan to comply with the special requirements when there is a declaration of disaster or emergency (including a public health emergency) and disruption in access to health care…
CMS is proposing to require thatplan applicants demonstrate they have a sufficient network of contracted providers to care for beneficiaries before CMS will approve an application for a new or expanded MA plan.
—Our proposal would require MA organizations and Part D sponsors to report the underlying cost and revenue information needed to calculate and verify the MLR [Medial Loss Ratio] percentage and remittance amount, if any. In addition, we propose to require that MA organizations report the amounts they spend on various types of supplemental benefits not available under original Medicare (e.g., dental, vision, hearing, transportation).”

Use of Preventive Care Services and Hospitalization Among Medicare Beneficiaries in Accountable Care Organizations That Exited the Shared Savings Program: “How is the exit of an accountable care organization (ACO) from the Medicare Shared Savings Program (SSP) associated with clinical quality delivered to beneficiaries, and does the association change over time after exit?…
In this cohort study of more than 1.7 million Medicare beneficiaries, SSP exit was associated with considerably lower rates of preventive service use, though not associated with rates of hospital utilization. These associations differed depending on how far removed an ACO was from SSP participation, where the reductions in clinical quality were most prominent in the first 2 years after exit…
Observations of declines in clinical quality after ACO exit from the SSP are important given recent changes to the SSP that could accelerate program exit.”

Today's News and Commentary

About Covid-19

White House: No plans to change definition of 'fully vaccinated': “‘Individuals are considered fully vaccinated against COVID-19 if they've received their primary series, that definition is not changing,’ Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said at a press briefing.
She said that the CDC is instead using the term ‘up to date’ to encourage people to get boosters.”

Pfizer to supply U.S. with 10 mln more courses of COVID-19 pills: “The Biden administration doubled its order for Pfizer Inc's oral COVID-19 antiviral treatment, the company and the White House said on Tuesday, providing the government a total of 20 million courses as it fights a record surge in COVID-19 cases.”

Unions go to court to get OSHA to release permanent COVID-19 protection standard: “The AFL- CIO, National Nurses United and other major unions filed a petition Wednesday in the U.S. Court of Appeals to force the Occupational Safety and Health Administration (OSHA) to make a permanent COVID-19 protection standard in place of the temporary measure installed last June.
Unions say a permanent standard that details minimum standards for equipment and staffing numbers is vital as the omicron variant has helped fuel surges of COVID-19 across the country.”

Omicron Causes Delay of FDA Inspections, as Well as Planning of In-Person Foreign Inspections: “The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022, as well as postponing nonmission-critical work.”

About the public’s health

Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life Years for 29 Cancer Groups From 2010 to 2019: “In this systematic analysis, there were 23.6 million new global cancer cases in 2019 (17.2 million when excluding those with nonmelanoma skin cancer), 10.0 million cancer deaths, and an estimated 250 million disability-adjusted life years estimated to be due to cancer; since 2010, these represent increases of 26.3%, 20.9%, and 16.0%, respectively. Absolute cancer burden increased in all SDI [Sociodemographic Index] quintiles since 2010, but the largest percentage increases occurred in the low and low-middle SDI quintiles…
The study results suggest that increased cancer prevention and control efforts are needed to equitably address the evolving and increasing burden of cancer across the SDI spectrum.”
See Figure 2 for “Cancer Group Rankings by Disability-Adjusted Life Years (DALYs) in 2019 and Percentage Change From 2010 to 2019.”

Trajectories of Prescription Drug Misuse Among US Adults From Ages 18 to 50 Years: “US adults born from 1965 to 1996 had high exposure to controlled medications, yet little is known about how this exposure has affected them over time. Prescription drug misuse (PDM) has increased among adults in the past 2 decades, with related increases in emergency department visits, overdoses, and deaths…
This cohort study included 11 cohorts of adolescents who were followed up longitudinally from age 18 years (study start, 1976-1986) to age 50 years (2008-2018) in the Monitoring the Future (MTF) study, which included a national multistage random sample of US 12th grade students.”
”In this cohort study of 26 575 individuals followed up from ages 18 to 50 years, nearly half of respondents reported prescription drug misuse. All prescription drug misuse trajectories had significantly increased odds of developing substance use disorder symptoms in adulthood, especially later peak trajectories, and baseline characteristics associated with prescription drug misuse trajectories included belonging to more recent cohorts, binge drinking, cigarette smoking, and using marijuana.”
One criticism is that 79.3% of study participants were white.

2022’s Best and Worst Cities for Active Life Style: At the top are San Francisco and Chicago. At the bottom are Winston-Salem (99) and North Las Vegas (100).

Pharmacists can give flu shots in states where they're not licensed, HHS says: “HHS is permitting pharmacists and qualified pharmacy interns to administer flu vaccines in states where they are not licensed or certified, effective Jan. 7. 
HHS released an amendment to the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, allowing licensed pharmacists and pharmacy interns in good standing to prescribe, dispense and administer flu shots in any state. Pharmacists may also order vaccines in states where they're not licensed.”

About healthcare IT

Study rates every state’s telehealth laws for patient access and ease of providing services: The study looks at eight dimensions that facilitate telehealth care. For example: “Only three states — Arizona, Florida, and Indiana — allow all providers to easily practice telehealth across state lines. Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

Hackers hit Broward Health network, potentially exposing data on 1.3M patients, staff: “The southeast Florida health system, which operates more than 30 healthcare locations in Broward County, disclosed it was hit with a cyberattack on Oct. 15, 2021, when an intruder gained unauthorized access to the hospital's network and patient data through a third-party medical provider, according to a statement posted to the health system's website Saturday…
Broward Health said it waited months to notify victims and make the breach public because the DOJ told them to hold off on sending out breach notification letters to preserve an ongoing law enforcement investigation…”

Ciox Health data breach affects ​​AdventHealth, Northwestern and 30 more providers: “Health information management company Ciox Health has notified 32 providers of an email security incident affecting their patients' protected health information.
The company said an unauthorized person accessed a Ciox employee's email account between June 24, 2021, and July 2, 2021, and they may have downloaded emails and attachments in the account.”
The article lists clients affected by the breach.

Stryker ponies up $3B to buy Vocera and amp up its digital communications: “The care coordination provider found new value during the COVID-19 pandemic, when clinicians and surgeons needed to find new ways to connect with their patients remotely and also to streamline their efforts to help meet the high demand for real-time, personal interactions.
Stryker said it plans to wield Vocera’s portfolio—which includes smartphone apps and workflow analytics software as well as its own hand-held communications hardware for hospital staff—to link up the medtech’s various data-generating medical devices.”

About pharma

Amgen chooses Generate in $1.9B biobucks deal to churn out up to 10 multispecific drugs: “The pair announced the deal Thursday morning, which includes $50 million upfront for the initial five program, with an option to collaborate on five more. Amgen will pay up to $370 million in milestones and also royalties for each resulting program from the pact, with a total potential transaction value of $1.9 billion in biobucks for Generate. Specific indications or disease areas were not disclosed in the announcement.”

Pfizer and BioNTech team up to develop mRNA-based shingles vaccine: “Pfizer and BioNTech have chosen to target shingles, for which GSK had a vaccine approved in 2017. GSK’s Shingrix is more than 90 per cent effective but the UK drugmaker has struggled to increase production to meet demand. Pfizer and BioNTech hope that a shot based on mRNA technology will be easier to scale up than Shingrix, which is a protein-based vaccine with an adjuvant.”

About health insurance

Complaints about medical billing: As previously reported, federal Surprise Medical Bill provisions became effective January 1. This CMS website allows patients to submit a complaint about such a bill.

North Carolina Physician Indicted for Adulterating Medical Devices for Reuse on Patients, Fabricating Records, and Other Charges: “A federal grand jury returned an indictment today charging a Raleigh woman with Adulteration of Medical Devices, Paying Illegal Remunerations, Making and Using Materially False Healthcare Documents, Mail Fraud, and Conspiracy.
According to the Superseding Indictment, between 2014 and 2018, Anita Louise Jackson, 58, billed Medicare more than $46 million for allegedly rendering more than 1,200 incidents of “balloon sinuplasty” services to more than 700 patients. Her practice, Greater Carolina Ear, Nose, and Throat (GCENT), received more than $5.4 Million for the services. During portions of this same time period, Jackson was the top-paid provider of balloon sinuplasty services in the United States, despite the location of her practice outside of a major metropolitan area. Jackson profited substantially from these billings to the Medicare program.”

About healthcare personnel

Governor Hochul Announces Direct Payments to Healthcare Workers as Part of $10 Billion Healthcare Plan: “Governor Kathy Hochul today announced a $10 billion multi-year investment in healthcare, the largest in State history, to rebuild and grow the healthcare workforce and strengthen the healthcare system as part of the 2022 State of the State. The plan will invest $10 billion in New York State’s healthcare sector, including more than $4 billion to support wages and bonuses for healthcare workers, and will invest in the healthcare workforce development pipeline to meet the current and increasing demand for medical professionals.”

Today's News and Commentary

About Covid-19

CDC Backs Boosters for High-Risk Kids Aged 5-11, Shorter Time Between Shots: “The U.S. Centers for Disease Control and Prevention on Tuesday backed the emergency use approval of Pfizer's booster shot for high-risk kids between the ages of 5 and 11, along with shortening the time period between a second dose and a booster shot from six months to five months.
Both approvals came from the U.S. Food and Drug Administration on Monday…”

CDC recommend Pfizer-BioNTech booster for 12-to-17-year-olds: “The Centers for Disease Control and Prevention recommended Wednesday that children 12- to 17-years-old should get a Pfizer-BioNTech coronavirus vaccine booster, expanding protection to adolescents and teens as surging infections threaten to disrupt schools and workplaces across the country.”

A variant found in France is not a concern, the W.H.O. says.: “The World Health Organization says that it is monitoring a coronavirus variant detected in a small number of patients in France, but that, for now, there is little reason to worry about its spread.
The B.1.640.2 variant was first identified in October and uploaded to Gisaid, a database for disease variants, on Nov. 4. Only about 20 samples have been sequenced so far, experts said this week, and only one since early December.
Abdi Mahmud, a Covid incident manager with the W.H.O., told reporters in Geneva on Tuesday that the variant had been on the agency’s radar since November, but added that it did not appear to have spread widely over the past two months.”

Omicron estimated to be 95.4% of coronavirus variants in U.S. - CDC: “The Omicron variant was estimated to be 95.4% of the coronavirus strains circulating in the United States as of Jan. 1, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”

Biden’s coronavirus testing push will need to face the ghost of websites past: “The swift spread of the omicron variant has laid bare the dearth of coronavirus tests nationwide, prompting President Biden last month to announce plans to make 500 million rapid tests available in part through a new federal website where citizens can sign up to receive them.
If history is any indication, though, the portal’s launch could face some of the same technological stumbling blocks that have plagued similar projects in the past.”

Israeli study reports fivefold jump in antibodies with 4th Pfizer vaccine shot: “A fourth shot of the Pfizer-BioNTech coronavirus vaccine generated a fivefold boost in antibodies a week after the jab, according to preliminary results of a study made public by the Israeli government Tuesday…
‘The fourth shot acted just like the first and second shots,’ said Sheba spokesperson Steve Walz. ‘A few people had low fevers, a few had sore arms but nothing more than that.’”

Existing vaccines effective against severe Omicron, study suggests: “Cellular immunity elicited by the BioNTech/Pfizer and Johnson & Johnson Covid-19 vaccines is effective against the Omicron coronavirus variant, according to a study, suggesting vaccines will protect against severe disease even if the antibody responses against the strain are not as strong or durable. The findings, contained in a new Harvard medical school study, add to evidence that the current vaccines hold up against severe Covid outcomes, and could help health authorities to decide whether to switch to Omicron-targeted jabs.”

COVID-19 Oral Vaccine and Antibody Booster: B. subtilis Spores, Biotechnology Breakthrough by DreamTec: “In its recently published peer-reviewed paper in an international medical journal Vaccines, which demonstratesBacillus subtilis (B. subtilis) spores, expressing a SARS-CoV-2 spike protein receptor binding domain (sRBD) on their surface can then produce neutralizing antibodies. DreamTec conducted a pilot study for a new COVID-19 oral vaccine which is able to elicit an immune response in both mice and human volunteers without adverse effects…”

Dr. Reddy’s to Price Generic Pill of Merck’s COVID-19 Antiviral at 50 Cents: “Generics giant Dr. Reddy’s Laboratories has reportedly priced its generic version of Merck’s COVID-19 oral antiviral, molnupiravir, at approximately 50 cents a pill.
Shortly before the new year, Dr. Reddy’s won Emergency Use Authorization from the Drugs Controller General of India allowing the company to produce its generic, which will be sold under the brand name Molflu in India. The drug will reportedly be made available to Indian pharmacies starting next week.”

COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly: From the Office of HHS OIG: “Medicare Part B spent $1.5 billion on COVID-19 tests in 2020, while at the same time, spending on non-COVID-19 tests declined by $1.2 billion. The result was a net spending increase of 4 percent, but the decrease in utilization of non-COVID-19 tests raises questions about the potential impacts on beneficiary health.”

U.S. reports over 1 million new daily Covid cases as omicron surges: “The U.S. has reported a record single-day number of daily Covid cases, with more than 1 million new infections.
A total of 1,082,549 new coronavirus cases were reported Monday, according to data compiled by Johns Hopkins University, as the highly infectious omicron variant continues to spread throughout the country and beyond.
The U.S. also has the highest seven-day average of daily new cases in any country tracked by Johns Hopkins.”

Walmart, Kroger Raise Prices of Covid-19 Test Kits: “Walmart Inc. and Kroger Co. are raising their prices for BinaxNOW at-home rapid tests, after the expiration of a deal with the White House to sell the test kits at cost for $14…
The deal with the White House expired in December, and Walmart said this week that it is raising the kits’ price to $19.98 a box. Kroger now sells them for $23.99. The BinaxNOW tests aren’t currently available on Amazon.”

Walmart to offer COVID-19 antiviral prescriptions: “Walmart said Pfizer’s Paxlovid and Merck’s Molnupiravir, both oral medicines, will be available at some Walmart and Sam’s Club pharmacies this week as supplies allow….
Since Paxlovid and Molnupiravir are prescribed to people with COVID-19, the drugs will be available at Walmart and Sam’s Club only via curbside pickup or drive-through pharmacy windows, according to Walmart.”

About health insurance

Centene closes $2.2B acquisition of Magellan Health: “Centene has completed its $2.2 billion acquisition of managed care organization Magellan Health, moving the insurer further into the behavioral health space, the company said Tuesday.
Centene and Magellan cleared all regulatory hurdles, both at the state and federal level, a condition of closing the deal. Magellan will operate independently under the Centene umbrella and will continue to be led by CEO Ken Fasola…
Magellan will add 5.5 million members and boost Centene's established presence in specialty healthcare and pharmacy management.”

About pharma

Delaware Judge Denies Sarepta Protection Under Hatch-Waxman “Safe Harbor”: On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent No. 10,526,617 filed by Regenxbio, Inc. (‘Regenx’) and the University of Pennsylvania (‘UPenn’).
The ‘617 patent claims a ‘cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein.’  Regenx and UPenn alleged that Sarepta manufactured and used cells covered by the ‘617 patent in order to make certain gene therapy products including Sarepta’s ‘SRP-9001…
In denying Sarepta’s motion, Judge Andrews agreed with Regenx and relied on Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), a case which found that the Safe Harbor did not apply to use of a patented optical spray analyzer that was used in connection with regulatory submissions for aerosol drug delivery systems but was itself not subject to regulatory approval. Citing several district court rulings following Proveris, Judge Andrews held that “a patented product that is not subject to FDA premarket approval is not a ‘patented invention’ under §271(e)(1)” and is therefore not covered by the Safe Harbor.”
The text of the decision quotes from the Hatch-Waxman Act:
“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

DC Circ. Revives Terror-Funding Case Against AstraZeneca: “The D. C. Circuit on Tuesday revived a lawsuit accusing AstraZeneca, Pfizer and several other pharmaceutical companies of helping to finance terror acts — through lucrative medical goods contracts with Iraq's health ministry — that have injured or killed hundreds of U. S. service members and civilians in the country between 2005 and 2011. A three-judge panel overturned and remanded a D. C. federal court's July 2020 dismissal order, which found that service members and other victims of the Hezbollah-linked militia group Jaysh al-Mahdi failed to state claims for either direct or secondary "aiding-and-abetting" liability under the Anti-Terrorism Act, or ATA.”

About hospitals and health systems

Hospitals Still Not Fully Complying With Federal Price-Disclosure Rules: “No hospitals have been penalized as of late December, according to the Centers for Medicare and Medicaid Services, which is responsible for enforcing the rules. The maximum penalty this year for violators is $109,500 per hospital, and the penalty increases to as much as $2 million in January.
The agency has issued approximately 335 warnings for violations and is giving hospitals information and technical help to increase compliance as of early December, a CMS spokeswoman said. Regulators also requested that 98 hospitals submit plans for how and when they would comply.”

Today's News and Commentary

About Covid-19

Emergence in Southern France of a new SARS-CoV-2 variant of probably Cameroonian origin harbouring both substitutions N501Y and E484K in the spike protein: “Here we describe the emergence of a new variant. For twelve SARS-CoV-positive patients living in the same geographical area of southeastern France, qPCR testing that screen for variant-associated mutations showed an atypical combination. The index case returned from a travel in Cameroon.”

Israel reports world's first 'flurona' influenza-COVID double infection: “The world's first documented case of ‘flurona,’ or simultaneous infections of COVID-19 and influenza viruses, has been recorded in Israel, doctors said.
The first known case of the double infection was identified in a woman who was giving birth last week at Rabin Medical Center in Petah Tikva, Israel, the Times of Israel and the Yedioth Ahronot newspaper reported.
Hospital officials said the young mother, who was not vaccinated against either illness, did not suffer any permanent consequences and was released from the hospital on Thursday.”

Interval between Moderna COVID-19 vaccine second shot and booster still six months -FDA: “The interval between receiving a second dose of Moderna' s COVID-19 vaccine and a booster dose remains unchanged at six months, U.S. Food and Drug Administration Acting Commissioner Janet Woodcock said on Monday.
‘Right now if you got J&J you get a booster after two months, if you got Pfizer as your primary series you can get a booster at five months or beyond, if you got Moderna you can get a booster at six months or beyond whatever you decide to get a booster of,’ Woodcock said on a press call.”

Paradoxical sex-specific patterns of autoantibody [AAB] response to SARS-CoV-2 infection: “In multivariable analyses, we observed sex-specific patterns of autoreactivity associated with the presence or absence (as well as timing and clustering of symptoms) associated with prior COVID-19 illness. Whereas the overall AAB response was more prominent in women following asymptomatic infection, the breadth and extent of AAB reactivity was more prominent in men following at least mildly symptomatic infection. Notably, the observed reactivity included distinct antigens with molecular homology with SARS-CoV-2.”

Medication safety group issues alert on COVID-19 antiviral: “The Institute for Safe Medication Practices on Jan. 3 issued an alert warning pharmacists of potential error risks with Paxlovid, Pfizer's COVID-19 antiviral pill regimen. 
The alert states patients with severe renal impairment should not receive the drug, and patients with moderate renal impairment should receive a dose reduction. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken twice daily for no more than five consecutive days…
ISMP said additional potential safety issues include patients accidentally failing to take both tablets together and drug interactions.”

About health insurance

CMS wants insurers to offer standardized plan options on the ACA exchanges: The proposed ACA rules reported yesterday have a provision for standardizing offerings. Medicare supplements have had this feature for many years and it makes comparisons among plans much easier.

ACO Investment Model Produced Savings, But The Majority Of Participants Exited When Faced With Downside Risk: “Medicare’s Accountable Care Organization (ACO) Investment Model (AIM) provided up-front funding to forty-one small, rurally located ACOs to encourage their participation in the Medicare Shared Savings Program. We estimate net savings to Medicare of $381.5 million over three years, driven by utilization reductions in inpatient and other institutional care and by the absence of shared risk for potential increases in Medicare spending incurred by participants. These savings suggest that population-based payment models can enable providers to better meet the needs of rural populations through greater flexibility in care delivery. However, nearly two-thirds of AIM ACOs exited the Medicare Shared Savings Program when faced with the requirement to assume downside financial risk, starting in year four of participation.”

About healthcare technology

Jury finds Theranos founder Elizabeth Holmes guilty of fraud: “After seven days of deliberations, a federal jury found Holmes, 37, guilty of defrauding investors while raising money for Theranos. Holmes was convicted of conspiracy to defraud investors and three counts of wire fraud. The jury found her not guilty of conspiring to defraud patients and cleared her on two individual patient-related charges and one count of lying in paid advertisements. The jury couldn’t reach a unanimous verdict on three counts of defrauding individual investors, possibly leaving the door open for a retrial on those specific charges.”
No word yet about appeals or the government going to trial again on the undecided counts.

About healthcare IT

Differences in estimates for 10-year risk of cardiovascular disease in Black versus White individuals with identical risk factor profiles using pooled cohort equations: an in silico cohort study: Another example of an algorithm that produces inaccurate results because of faulty race data. [Emphasis added below].
“Sex-specific and race-specific pooled cohort equations (PCEs) are recommended for estimating the 10-year risk of cardiovascular disease, with an absolute risk of more than 7·5% indicating a clinical decision threshold. We compared differences between Black and White individuals in PCE-estimated absolute cardiovascular disease risk across various plausible risk factor combinations with the aim of evaluating if using the PCE might result in different clinical decisions in Black versus White individuals with identical risk profiles….
There are several clinical implications of our findings. First, the use of PCE could result in Black individuals with select risk factor combinations becoming more eligible for receiving statin treatment than their White counterparts with identical risk profiles. Although the direction of this potential bias might seem somewhat reassuring (relative to the opposite scenario of Black individuals not receiving statins relative to their White counterparts), the risks associated with over-treatment—ie, financial, psychological, side-effects, and quality of life—are not trivial.”

About pharma

2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs: “All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others.
Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron.”
The article has details on each drug.

List prices for 460 drugs increased Jan. 1: “Drugmakers on Jan. 1 increased the list price of 460 medications by a median of 4.9 percent, according to data from 46brooklyn, a nonprofit drug research firm. 
The price hikes are comparable to those seen at the start of previous years. On Jan. 1, 2021, drugmakers increased the price of 629 drugs.”

Today's News and Commentary

HAPPY NEW YEAR!

About Covid-19

FDA authorizes coronavirus vaccine boosters for 12- to 15-year-olds as schools reopen amid omicron surge: “The agency also said everyone at least 12 years old could get a booster dose five months after receiving the second Pfizer-BioNTech shot; previously, boosters were stipulated for six months. And it cleared booster shots for some children ages 5 to 11 who have compromised immune systems.
The FDA actions are expected to be reviewed by the Centers for Disease Control and Prevention and its panel of outside vaccine advisers this week. Assuming the Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday, signs off on the additional shots, CDC director Rochelle Walensky is expected to officially recommend them later that day.”

States report record COVID-19 cases entering 2022: “The United States reported 2.7 million new COVID-19 cases in the week ending with New Year's Eve on Friday, up 105% from the previous week, as the nation has reported a total of 54,771,160 infections and 825,561 coronavirus-related deaths since the start of the pandemic, according to data gathered by Johns Hopkins University.”

CMS releases guidance on healthcare worker vaccination mandate: “CMS has released guidance and survey procedures for the 25 states where its COVID-19 vaccination mandate for healthcare workers is not currently blocked…
The guidance does not apply to 25 states where the mandate is blocked: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. However it does apply to the remaining 25 states.”

Fauci: CDC mulling COVID test requirement for asymptomatic: “Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant ‘pushback’ on its updated recommendations last week.
Under that Dec. 27 guidance, isolation restrictions for people infected with COVID-19 were shortened from 10 days to five days if they are no longer feeling symptoms or running a fever. After that period, they are asked to spend the following five days wearing a mask when around others.”

Israel now offering fourth covid shot to anyone 60 and older: “Israel on Monday began offering anyone over 60 a chance to get a fourth shot of a coronavirus vaccine, greatly expanding a double-booster effort that previously included just older residents with compromised immune systems and some health-care workers.”

About pharma

Private-equity firm interested in Walgreens' U.K. drugstore chain: “U.S. private equity firm Bain Capital recently approached Walgreens Boots Alliance Inc. about a potential purchase of its U.K. drugstore chain Boots, the Times of London reported, without saying where it got the information. 
Bain is positioning itself as a front-runner for an upcoming auction of the unit, the newspaper said. Boots only owns about a quarter of its stores and may be worth 6 billion pounds ($8.1 billion) to 7 billion pounds, according to the report.”

New York PBMs must get licensure, registration under new law: “The legislation — S.3762/A.1396 — signed by Gov. Kathy Hochul Dec. 31, aims to improve transparency surrounding prescription drug costs and establishes a set of duties and obligations PBMs must follow when performing services, according to a news release. It also enables the department of financial services to enforce the law and receive complaints of PBM violations…
PBMs largely operate without regulation, with the bill marking the first such legislation in the country.”

Facebook ad ban may squelch medical research recruitment: “Under fire from critics over its privacy practices, Facebook is implementing a sweeping ban on advertisers targeting patients with messages based on their health conditions. And that could be bad news for drug development.
The decision by the social media giant, which takes effect in January, is part of a broader push to remove ad-targeting options for what it calls ‘sensitive’ topics and is getting measured praise from patient privacy advocates. But critics of the restrictions say the move could have an unintended side effect: Slowing biomedical research by making it harder to use Facebook to recruit people for clinical trials.”

This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020: “The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction.”
This action is one of many that rolled back the Trump administration’s healthcare initiatives.

About diagnostics

When They Warn of Rare Disorders, These Prenatal Tests Are Usually Wrong: This article is an excellent review of for-profit labs that earn significant revenues from performing tests for rare conditions, the results of which are highly inaccurate.
”To evaluate the newer tests, The Times interviewed researchers and then combined data from multiple studies to produce the best estimates available of how well the five most common microdeletion tests perform.
The analysis showed that positive results on those tests are incorrect about 85 percent of the time…
The Times reviewed 17 patient and doctor brochures from eight of the testing companies, including Natera, Labcorp, Quest and smaller competitors. Ten of the brochures never mention that a false positive can happen. Only one mentioned how often each test gets positive results wrong.”

About health insurance

HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule Fact Sheet: “Centers for Medicare & Medicaid Services (CMS) proposed standards for issuers and Marketplaces, as well as requirements for agents, brokers, web brokers, and issuers assisting consumers with enrollment through Marketplaces that use the federal platform.”
The provisions in this proposed rule fact sheet are too numerous to summarize, but the document can be read quickly to get an idea of its contents.

Today's News and Commentary

Covid-19

F.D.A. Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters:“The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses on Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.”

Johnson & Johnson booster slashes risk of Omicron hospitalisation, study shows: “Two doses of the Johnson & Johnson Covid-19 vaccine cut the risk of hospitalisation by up to 85 per cent, according to a South African study conducted when the Omicron coronavirus variant was dominant. The findings of the real-world study, made public on Thursday and not yet peer-reviewed, provide a significant fillip to the J&J shot, widely used in South Africa and elsewhere.”

Omicron-Infected People Also Mount Strong Resistance to Delta, Study Finds: “People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest.
However, immune response varies widely among unvaccinated people, suggesting that they may be susceptible to repeat Omicron infections as well as Delta reinfection, according to Alex Sigal, a virologist at the Africa Health Research Institute, Durban.”

Five tactics used to spread vaccine misinformation in the wellness community, and why they work: A really good explanation of the subject of the headline.

About pharma

HHS appeals judge's ruling that drugmakers can cut off 340B sales to contract pharmacies: “The Biden administration is appealing a federal ruling that said drugmakers have the authority to restrict sales of 340B-discounted products to contract pharmacies.
The Department of Justice filed an appeal Tuesday to a lawsuit brought by Novartis and United Therapeutics over drugmakers’ ability to cut off sales to contract pharmacies. It also appealed several aspects of other rulings in separate lawsuits brought by Eli Lilly, Sanofi and Novo Nordisk.”
And in a related article: AbbVie to restrict 340B discounts to safety net hospitals: “AbbVie said it will stop offering safety net hospitals 340B drug-pricing program discounts on drugs dispensed at contract pharmacies if the hospitals fail to turn over patient claims data for those pharmacies to the drugmaker.
AbbVie will begin the initiative Feb. 1, according to a Dec. 29 letter the drugmaker sent to safety net hospitals.”

New York jury holds drugmaker Teva liable in opioid crisis: “Drugmaker Teva Pharmaceuticals is responsible for contributing to the opioid crisis, a suburban New York jury ruled Thursday in one of few verdicts so far among thousands of lawsuits nationwide over the painkillers.
A separate trial will follow to determine what Teva will have to pay in the case…”

About medical devices

Chicago-based Hillrom faces antitrust lawsuit over hospital bed sales: “In the federal lawsuit filed Tuesday in Chicago, hospital bed-maker Linet alleges Hillrom, the main provider of hospital beds in the U.S., used ‘anti-competitive’ practices to slow Linet’s growth in the U.S. market, including “coercing” hospital administrators into locking entire health systems into long-term agreements. 
Hillrom, which the lawsuit calls a ‘serial abuser of antitrust laws,’ makes up at least 70% of standard, intensive care and birthing beds installed in U.S. hospitals, according to the complaint.”
Considering the recent Baxter announcement that it is purchasing Hillrom, the timing of the suit is “interesting.”

FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency: The FDA published “guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization (EUA) process (EUA Devices) and those under temporary FDA policies implementing specific enforcement discretion during the pandemic (Enforcement Policy Devices) once the Public Health Emergency for COVID-19 (PHE) ends. These guidance documents, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Transition Plan Guidances), are critically important for manufacturers that developed and produced new devices or modified legally marketed devices specifically in response to the pandemic to help diagnose, cure, treat, or mitigate the symptoms of COVID-19.”

About health insurance

Increasing Medicaid’s Stagnant Asset Test For People Eligible For Medicare And Medicaid Will Help Vulnerable Seniors: “We estimated that increasing Medicaid’s asset limit by the Consumer Price Index, to Medicare Savings Program levels, or to $10,000 for individuals and $20,000 for couples would increase Medicaid eligibility by 1.7 percent, 4.4 percent, and 7.5 percent, respectively. Simplifying Medicaid’s asset test to focus only on certain high-value assets would increase eligibility by 20.5 percent. Increasing asset limits would lessen restrictions on Medicaid eligibility that arise from stagnant asset tests, broadening eligibility for certain low-income Medicare beneficiaries and allowing them to retain higher, yet still modest, savings.”

About healthcare IT

AP-NORC SURVEY: USE OF TELEHEALTH BY OLDER ADULTS WIDESPREAD DURING THE PANDEMIC, BUT ADDRESSING ACCESS ISSUES AND QUALITY CONCERNS KEY TO SUSTAINING ITS USE: “According to the survey, funded by The SCAN Foundation, 62% of adults age 50 and older have received care through some form of telehealth since the beginning of the pandemic, especially for non-urgent health concerns and prescription consultations. Those who have received care through telehealth were generally comfortable doing so, and nearly two-thirds are at least somewhat likely to seek care through telehealth after the pandemic ends.
The convenience of finding an appointment, meeting with a specific provider, and getting an immediate response are the top reasons why adults age 50 and older choose telehealth over in-person care. On the other hand, about two-thirds express concerns about the quality of care received through telehealth.”

Association of Physician Characteristics With Early Adoption of Virtual Health Care: “In a cross-sectional study of 3473 physicians in a large regional health care system, more than 94% transitioned to include virtual health care in their practice by December 2020. Female, behavioral health, and primary care physicians were more likely to be early adopters, and physicians born between 1928 and 1945 (Silent Generation) and in surgical specialties were less likely to be early adopters.”

Today's News and Commentary

About Covid-19

New COVID-19 cases in US soar to highest levels on record: “More than a year after the vaccine was rolled out, new cases of COVID-19 in the U.S. have soared to their highest level on record at over 265,000 per day on average, a surge driven largely by the highly contagious omicron variant.
New cases per day have more than doubled over the past two weeks, eclipsing the old mark of 250,000, set in mid-January, according to data kept by Johns Hopkins University.”

Monitoring Variant Proportions: Latest CDC revisions on variant frequencies: Omicron is 58.6%. The rest is essentially delta.

FDA says antigen tests may be less sensitive to omicron: “The Food and Drug Administration (FDA) on Tuesday warned that antigen tests may be less effective in detecting the highly contagious omicron variant of COVID-19.
‘Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,’ the FDA announced.

Short Supply Limits Access to Newly Authorized COVID-19 Oral Pills: “Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year.
This even though the U.S. government has placed a $5.3 billion order for 10 million treatment courses of Paxlovid (nirmatrelvir, ritonavir) for shipments to states through 2022 and a $2.2 billion order for an estimated 3 million treatment courses of molnupiravir for delivery through early next year.”

Statement on the Status of the OSHA COVID-19 Healthcare ETS [Emergency Temporary Standard]: “On June 21, 2021, OSHA adopted a Healthcare Emergency Temporary Standard (Healthcare ETS) protecting workers from COVID-19 in settings where they provide healthcare or healthcare support services. 86 FR 32376. Under the OSH Act, an ETS is effective until superseded by a permanent standard – a process contemplated by the OSH Act to occur within 6 months of the ETS’s promulgation. 29 U.S.C. 655(c). OSHA [announced Monday] that it intends to continue to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards, and will do so as it also considers its broader infectious disease rulemaking. However, given that OSHA anticipates a final rule cannot be completed in a timeframe approaching the one contemplated by the OSH Act, OSHA also [announced Monday] that it is withdrawing the non-recordkeeping portions of the healthcare ETS.”

About health insurance

Patients won't have to fear as many surprise medical bills come January: “The No Surprises Act, which bans most unexpected medical charges from out-of-network providers, is scheduled to go into effect January 1. It will apply to about 10 million surprise bills a year, according to federal estimates.
The new law, which Congress approved in late 2020 after a multitude of delays, protects patients when they receive emergency care or scheduled treatment from doctors and hospitals that are not in their insurance networks and that they did not choose. Consumers would be responsible only for their in-network cost-sharing in these situations.”

Mental Health Support to Get Expansion Under New Medicaid Option: “States can integrate behavioral health services into their Medicaid programs under a new option meant to help people experiencing mental health or substance use crises.
The Medicaid option will allow states to support mobile crisis intervention services, which connect users to a behavioral health specialist on call, the Biden administration announced Tuesday.”

About the public’s health

Association of e-Cigarette Use With Discontinuation of Cigarette Smoking Among Adult Smokers Who Were Initially Never Planning to Quit: “In this US nationally representative cohort study of 1600 adult daily cigarette smokers who did not initially use e-cigarettes and had no plans to ever quit smoking, subsequent daily e-cigarette use was significantly associated with an 8-fold greater odds of cigarette discontinuation compared with no e-cigarette use.”

Today's News and Commentary

About Covid-19

U.S. sets record high for coronavirus infections: “The lightning spread of the coronavirus’s omicron variant in the United States pushed the seven-day average of new daily cases to 253,245 as of Tuesday afternoon, surpassing the previous high of 248,209 cases on Jan. 12.”

Booster protection wanes against symptomatic Omicron infections, British data suggests.: New data from Britain suggests that booster protection against symptomatic Covid caused by the Omicron variant wanes within 10 weeks.
There have not yet been enough severe cases of Omicron to calculate how well boosters protect against severe disease, but experts believe the shots will continue to provide significant protection against hospitalization and death.”

Supreme Court sets Jan. 7 hearing on vaccine mandate rules: “The Supreme Court…announced it will hear oral arguments to legal challenges against the Biden administration's COVID-19 vaccination mandates covering both healthcare employers and employers of businesses with 100 or more workers.
The justices will consider whether the rules will take effect in a special hearing Jan. 7, amid a flurry of legal challenges to both state and federal vaccination mandates with looming deadlines for employers to comply.
The high court already blocked challenges to three states' vaccine mandates, upholding the requirement for the jab. Though two federal courts granted preliminary injunctions to some states challenging the CMS mandate that still stands.”

About the public’s health

Flu is making a comeback in US after an unusual year off: “The U.S. flu season has arrived on schedule after taking a year off, with flu hospitalizations rising and two child deaths reported.
Last year’s flu season was the lowest on record, likely because COVID-19 measures — school closures, distancing, masks and canceled travel — prevented the spread of influenza, or because the coronavirus somehow pushed aside other viruses.
‘This is setting itself up to be more of a normal flu season,”’said Lynnette Brammer, who tracks flu-like illnesses for the U.S. Centers for Disease Control and Prevention.”

Two New Pneumococcal Vaccines—Prevnar 20 and Vaxneuvance: “The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes.”
Check Table 3 for new immunization recommendations.

About healthcare finance

Healthcare Underperformed S&P 500 In 2021 For Third Year Straight: “Poor performances in the biotech and digital health sectors dragged down the rest of the industry, the report found. Those losses were partially offset by strong gains across healthcare providers, insurers and life science tools and diagnostics. Overall, SVB Leerink found healthcare companies gained 22% in 2021 through Dec. 17, compared with 24% across the S&P 500. 
Within healthcare, life sciences tools and services saw the highest gains in 2021, at 35.5%, which was on par with the sector’s 2020 performance. Second was healthcare providers and services, which gained 30.7%, more than double its 2020 performance.”

About rural health

Rural Communities Left Hurting Without a Hospital, Ambulance or Doctors Nearby “About 20% of the nation lives in rural America, but only about 10% of U.S. physicians practice in such areas, according to the National Conference of State Legislatures.
And 77% of the country’s rural counties are designated as health professional shortage areas. About 4,000 additional primary care practitioners are needed to meet current rural health care needs, the Health Resources and Services Administration has estimated.”

Today's News and Commentary

About Covid-19

Israel begins studying the effectiveness of a 4th vaccine dose: “Officials at Sheba Medical Center, near Tel Aviv, said that their study was the first of its kind in the world and involved administering an additional shot to 150 medical personnel who had received a third dose of the Pfizer-BioNTech vaccine at least four months ago.”

CDC cuts isolation time recommended for people with asymptomatic coronavirus infections to five days: “Federal health officials shortened the recommended time Americans infected with coronavirus should isolate from 10 days to five if they are asymptomatic — a decision they said was driven by a growing body of research about when people are most infectious.
The Centers for Disease Control and Prevention also cut the quarantine time to five days for those exposed to coronavirus who are not boosted. In addition, they recommended such people wear masks around others for an additional five days.”

About pharma

Pharmacy of the world: China’s quest to be the No. 1 drugmaker: A great review of pharma development and plans in China.

About hospitals and health systems

LifePoint Health and Kindred Healthcare close deal to form new company: “LifePoint Health and Kindred Health closed the deal on Thursday to form a new company of 61 Kindred Long Term Emergency Hospitals and 18 LifePoint Community Hospitals.
ScionHealth, which is expected to generate approximately $ 3.5 billion in annual revenue, is independently managed by former LifePoint and Kindred executives and a new board of directors. Kindred CEO Benjamin Breuer left the company after the close of the deal, but executives said the company does not expect ‘significant job losses’ or consolidation of service lines.”

Today's News and Commentary

About Covid-19

Remdesivir can help keep unvaccinated, high-risk people with covid-19 out of hospitals, study finds: “The antiviral drug remdesivir can help keep unvaccinated people at risk of severe covid-19 out of hospitals, according to a study that found the treatment reduced hospitalization and death by 87 percent when given soon after diagnosis.”

Supreme Court to Hold Special Hearing on Biden Vaccine Mandates: “The Supreme Court said on Wednesday evening that it would hold a special hearing next month to assess the legality of two initiatives at the heart of the Biden administration’s efforts to address the coronavirus in the workplace.”

FDA authorizes Merck’s anti-coronavirus pill, a second at-home treatment option: “Doctors have clamored for easy-to-use medications throughout the pandemic, but the new drug, molnupiravir, has had an uneasy reception because of its modest efficacy and potential safety risks. Some experts say another tool will be helpful as the omicron variant, which is resistant to other key treatments, surges. But others say they would be hesitant to use the drug.
The Food and Drug Administration authorized the five-day course of treatment in patients 18 and older who are at high risk of severe covid-19 and ‘for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.’”

Early studies suggest a reduced risk of Covid-19 hospitalization when infected with Omicron compared to Delta: “Omicron is associated with a two-thirds reduction in the risk of Covid-19 hospitalization compared with Delta, suggests one study, released online Wednesday as a working paper by researchers at the University of Edinburgh in the United Kingdom. That research was based out of Scotland.
The other paper, posted Tuesday to the online server medrxiv.org, suggests that people with Omicron infections have had 80% lower odds of being admitted to the hospital compared with Delta infections. But once a patient was hospitalized, there was no difference in the risk of severe disease, according to that research, based out of South Africa.”

Hospitals Scramble as Antibody Treatments Fail Against Omicron: “Two of the three monoclonal antibody treatments that doctors have depended on to keep Covid-19 patients from becoming seriously ill do not appear to thwart the latest version of the coronavirus.
The one such treatment that is still likely to work against Omicron is now so scarce that many doctors and hospitals have already run through their supplies.”

About health insurance

ObamaCare open enrollment hits record numbers: “A record 13.6 million people have enrolled in health insurance coverage through the Affordable Care Act to date, with another month left before open enrollment ends, Biden administration officials said Wednesday.
According to the Centers for Medicare and Medicaid Services (CMS), more than 9.7 million Americans enrolled in coverage in the 33 states using HealthCare.gov for 2022 from the start of open enrollment through Dec. 15. 
CMS said there were over 900,000 more people compared to the previous all-time high of 8.8 million who signed up during the 2018 Open Enrollment Period, when there were 39 states using HealthCare.gov.”

IN NEW YORK CITY, RETIREES BRACE FOR SWITCH TO PRIVATIZED HEALTH CARE: STARTING IN JANUARY 2022, over a quarter million former New York City government workers and their dependents are set to be shifted off Medicare and on to privatized health insurance. Mayor Bill de Blasio and the Municipal Labor Committee, which represents retired New York City employees, announced the move in mid-July, following several months of scrambled protest from bewildered retirees.
The plan has been cast as a necessary measure to rein in mounting health care costs and reduce strain on the city’s budget. While public sector retirees in New York City are currently insured by Medicare, the federal government’s program for people over 65, the city reimburses them for outpatient care, as well as for a ‘Medigap’ plan that offers additional services. City officials and union leaders have negotiated a deal that they claim will save upward of $600 million by switching to Medicare Advantage, the federally funded privatized health insurance program that launched ostensibly to give consumers more choice and reduce Medicare costs.”

About pharma

Novartis to Buy Gene-Therapy Company Targeting Eye Condition: Swiss healthcare giant to pay up to $1.5 billion for British biotech Gyroscope: “The acquisition will hand Novartis an experimental gene therapy for geographic atrophy, a form of age-related macular degeneration that can lead to permanent vision loss. The treatment, known as GT005, is designed to increase the production of a protein, called CFI, that is thought to reduce damaging inflammation. That treatment is in mid-stage clinical trials.”

Japanese Health Ministry Panel Rejects Biogen’s Aducanumab: “A Japanese Health Ministry expert panel has declined to endorse Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), citing inconclusive trial results and the need for more efficacy data before signing off on an approval.”

About hospitals and health systems

Tenet closes $1.1B surgery center deal: “Dallas-based Tenet paid $1.1 billion to acquire SurgCenter Development's ownership interests in 86 ambulatory surgery centers and related services, the company said in a Dec. 22 news release. USPI has offered to acquire a portion of equity interests in the ASCs from physician owners for $250 million.”

Today's News and Commentary

About Covid-19

Fauci says quarantines may be shortened for asymptomatic health care workers: Fauci told CNN that while there are ‘no decisions yet,’ changing the guidance is an "important consideration that is being discussed right now."
‘Rather than keeping [health care workers] out for seven to 10 days, if they are without symptoms, put a N95 mask on them, make sure they have the proper PPE, and they may be able to get back to work sooner than the full length of the quarantine period,’ Fauci said to CNN.”

FDA authorizes Pfizer’s anti-covid pill as omicron surges: “Tens of thousands of pill packs of Pfizer’s Paxlovid are sitting in a Pfizer warehouse in Memphis, ready to be loaded onto trucks and planes in anticipation of the green light from the Food and Drug Administration. But as omicron cases skyrocket nationwide, doctors are expected to quickly burn through that initial supply of Paxlovid, which has shown to be 89 percent effective at keeping high-risk patients from developing severe illness when given within three days of symptoms starting.”

Oxford and AstraZeneca developing Omicron-targeted version of vaccine: The headline is the story.

California to require boosters for healthcare workers: “The announcement came after California issued an order Aug. 5 requiring workers in healthcare settings to be fully vaccinated. [Gov.} Newsom is expected to make an official announcement about the move related to boosters on Dec. 22 as part of new state actions amid increasing COVID-19 case rates and hospitalizations.”

Biden seeks to recast pandemic fight, rejecting lockdowns and school closures as omicron surges: “Biden detailed new plans to expand coronavirus testing sites across the country, distribute a half-billion free at-home tests and deploy more federal health resources to aid strained hospitals as the omicron variant drives a fresh wave of infections.”

Israel to offer fourth COVID-19 vaccine dose in bid to outpace Omicron: “Israel is to offer a fourth dose of a COVID-19 vaccine to people older than 60 or with compromised immune systems, and to health workers, as part of a drive to ramp up the shots and outpace the spread of the Omicron variant of the coronavirus.”

Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma: [Preprint, not yet peer reviewed]
”Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic.”

About health insurance

Medicaid Expansion May Be Associated with Lower Mortality Rates: “States that implemented Medicaid expansion saw reductions in all-cause mortality rates compared to nonexpansion states, a study from the Keck School of Medicine at the University of Southern California (USC) found…
Medicaid expansion states had lower mortality rates compared to nonexpansion states, the results revealed. All-cause mortality was 311 per 100,000 adults in expansion states and 365 per 100,000 adults in nonexpansion states. Expansion states also had 11 fewer deaths per 100,000 adults per year than nonexpansion states.”

About pharma

FDA approves first injectable HIV preventive, providing alternative to daily pill: “The injectable drug, Apretude, is given first as two injections one month apart and then once every two months. It was approved for use in ‘at-risk’ adults and adolescents weighing at least 77 pounds. Recipients are required to test negative for HIV before starting the drug and before each injection ‘to reduce the risk of developing drug resistance,’ the FDA said.”

More than 800 hospitals urge HHS to appeal controversial ruling in 340B lawsuit: “More than 800 hospitals are urging the Biden administration to appeal a federal court ruling that drugmakers have the power to restrict sales of 340B-discounted drugs to contract pharmacies.
The appeal comes as drugmakers are taking the Biden administration to court over its attempts to fine the companies for restricting sales to the contract pharmacies.”

About the public’s health

US population growth at lowest rate in pandemic’s 1st year: “U.S. population growth dipped to its lowest rate since the nation’s founding during the first year of the pandemic as the coronavirus curtailed immigration, delayed pregnancies and killed hundreds of thousands of U.S. residents, according to figures released Tuesday.
The United States grew by only 0.1%, with an additional 392,665 added to the U.S. population from July 2020 to July 2021, bringing the nation’s count to 331.8 million people, according to population estimates released by the U.S. Census Bureau.
The U.S. has been experiencing slow population growth for years but the pandemic exacerbated that trend. This past year was the first time since 1937 that the nation’s population grew by less than 1 million people.”

Life Expectancy in U.S. Declined 1.8 Years in 2020, CDC Says: “Final data released Wednesday by the Centers for Disease Control and Prevention show that Americans’ life expectancy fell 1.8 years to 77 years in 2020. The drop was 0.3 years more than that of provisional estimates released in July 2021 and remains the biggest life-expectancy decline since at least World War II. 
Covid-19 was the nation’s third leading cause of death last year, behind heart disease and cancer, and was the underlying cause in about 351,000 deaths, the new figures show. Increases in mortality from unintentional injuries—which include drug overdoses—as well heart disease, homicide and diabetes also decreased life expectancy.”

Trends in Public Stigma of Mental Illness in the US, 1996-2018: “To date, this survey study found the first evidence of significant decreases in public stigma toward depression. The findings of this study suggest that individuals’ age was a conservatizing factor whereas being in the pre–World War II or millennial birth cohorts was a progressive factor. However, stagnant stigma levels for other disorders and increasing public perceptions of likely violence among persons with schizophrenia call for rethinking stigma and retooling reduction strategies to increase service use, improve treatment resources, and advance population health.”


Today's News and Commentary

About health insurance

3 insurers to pay out $3.1M after health parity violations: “Aetna, Oscar Health and Wellfleet must pay $3.1 million after allegedly violating federal and New York mental health parity and cost-sharing laws.
A review by the New York Financial Services Department announced the payments after reviewing biannual parity reports from the payers, which found that the insurers had policies requiring members to illegally pay copays or coinsurance for mental health and substance use disorder benefits, according to a department news release
Between fines for parity and data-reporting violations, the payers owe $2.6 million in penalties and must return $473,565 to members.”

Public health emergency end could cause millions to lose Medicaid coverage: “The provision, a requirement under the Families First Coronavirus Response Act, which passed in March 2020, prevented states from removing Medicaid recipients from the program’s rolls. At least 11 million people have enrolled in Medicaid since February 2020.   
Up to 15 million people, including nearly 6 million children, could be at risk of losing their Medicaid eligibility when the protection expires [on January 15], according to the Urban Institute, an economic and policy research think tank. The change could have an outsize effect on communities of color, the Urban Institute concluded.
Many are likely to be eligible for other forms of subsidized coverage, the analysis found, but there is a concern that few people will know that they are in danger of losing Medicaid and are eligible for other types of health insurance. “
Although the emergency designation will probably be extended (given the omicron variant expansion of cases), coverage of these people will inevitably be a problem when the pandemic is back under control.

About Covid-19

CDC: Omicron now accounts for 73% of US cases; 1st US death reported: “The omicron coronavirus variant has quickly become the dominant strain in the U.S., accounting for 73.2 percent of new infections for the week ending Dec. 18, genomic surveillance data from the CDC shows. 
That's up from just 13 percent Dec. 11, the updated data reflects, underlining the strain's increased transmissibility. Before the data was updated on Dec. 20, the strain was believed to represent 3 percent of cases Dec. 14.”

Moderna steps back from Spikevax patent row with US government: “Moderna, which is locked in a dispute with the US National Institutes of Health (NIH) over who should be listed as co-inventors of its COVID-19 vaccine Spikevax, says it will not pursue issuance of a patent application for the jab's mRNA sequence "at this time." The company indicated that it made the decision in order to allow more time for discussions with the NIH.
Moderna has argued it was justified in listing its own scientists as sole inventors for Spikevax's mRNA sequence, while excluding three collaborators from the NIH who also worked on the vaccine. In its latest statement, Moderna reiterated that it believes company scientists "invented the specific mRNA sequence at the heart of the patent in question," although it "acknowledges that NIH feels equally strongly that its scientists should be listed as co-inventors for their contemporaneous work on the protein sequence."

About healthcare IT

HIPAA Privacy Rule and Disclosures of Protected Health Information for Extreme Risk Protection Orders: Guidance updated yesterday: “On June 7, 2021, the United States Department of Justice published model legislation to provide a framework for states to consider as they determine whether and how to implement their own “extreme risk protection order” (ERPO) laws. An ERPO is a court order that temporarily prevents a person in crisis, who poses a danger to themselves or others, from accessing firearms. ERPO legislation, which can vary in important ways among states, generally specifies certain categories of petitioners (e.g., law enforcement officers, family members, health care providers) who may apply to a court for an ERPO and includes requirements for affidavits or sworn oral statements from the petitioner or witnesses to support the application. This guidance addresses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule for covered health care providers in relation to ERPO laws.”

About the public’s health

988 suicide phone hotline getting $282M to ease July launch: “ People in crisis and those trying to help them will have a new phone number — 988 — to reach the national suicide prevention network starting in July. On Monday, federal health officials announced more than $280 million to smooth the transition from the current 10-digit number to three digits.”

About pharma

FDA Approves Second Biosimilar Insulin Product, Rezvoglar (insulin glargine-aglr) : ”The Food and Drug Administration approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). Rezvoglar (insulin glargine-aglr) is biosimilar to Lantus (insulin glargine).
Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus….
Rezvoglar is the second biosimilar insulin product and the 32nd biosimilar product approved in the U.S.”
More generics in a category causes prices to drop more.

About patient safety

Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005: “As required by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act),a the Secretary of the Department of Health and Human Services (HHS) has prepared this Final Report to Congress on effective strategies for reducing medical errors and increasing patient safety in consultation with the Director of the Agency for Healthcare Research and Quality (AHRQ). It includes measures determined appropriate by the Secretary to encourage the appropriate use of effective strategies for reducing medical errors and increasing patient safety, including use in federally funded programs. As the Patient Safety Act also required, a draft of this report was made available for public comment and submitted for review to the Institute of Medicine, now the National Academy of Medicine. This Final Report, which is required to be submitted to Congress no later than December 21, 2021, includes updates and additions made to address feedback received from members of the public and the National Academy of Medicine.”
A “must-read” for those in charge of patient safety activities at their institutions.

Today's News and Commentary

About healthcare IT

 Oracle to buy medical records company Cerner in its biggest acquisition ever: “Enterprise software giant Oracle will buy electronic medical records company Cerner in an all-cash deal for $95 per share, or approximately $28.3 billion in equity value.
The deal, expected to close in calendar year 2022, could help Oracle boost its presence in health care by bringing troves of health data to its cloud services.
Oracle shares closed down 5% Monday after the companies announced the deal.”

Could facility fees for telehealth appointments return: “Facility fees can add hundreds or even thousands of dollars to a patient's bill and have come under criticism from patients and consumer groups. Hospitals argue these fees are necessary for keeping their facilities operational. Fees for video appointments are rare but have taken a few patients by surprise…
In 2021, only 1.1 percent of telehealth appointments included a facility fee. As telehealth continues to be used post-pandemic, it is unclear how appointments will be billed.”

 About health insurance

 Former West Hollywood Doctor and Company Associated with 1-800-GET-THIN Guilty of Massive Fraud Against Health Insurers: “ A former doctor and his company were found guilty today by a federal jury of scheming to defraud private insurance companies and the Tricare health care program for military service members by fraudulently submitting an estimated $355 million in claims related to the 1-800-GET-THIN Lap-Band surgery business…
Omidi used the sleep studies to find a reason – the “co-morbidity” of obstructive sleep apnea – that GET THIN would use to convince the patient’s insurance company to pre-approve the Lap-Band procedure.
After patients underwent sleep studies – irrespective of whether any doctor had ever determined the study was medically necessary – GET THIN employees, acting at Omidi’s direction, often falsified the results. Omidi then used the falsified sleep study results in support of GET THIN’s pre-authorization requests for Lap-Band surgery.”

CMS: Insurers paid out $2B in medical loss ratio rebates for 2020 claims:   “Insurers gave out approximately $2 billion in rebates for 2020 to nearly 10 million consumers under the Affordable Care Act’s (ACA's) medical loss ratio provision…
A plan must send rebates to customers by Sept. 30 via either a premium credit, lump-sum check, credit card or direct debit.
‘For the 2020 reporting year, health insurers provided approximately $1.3 billion in rebates in the individual market, $384 million in the small group market and $291 million in the large group market,’ CMS said.”

Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder: Findings from HHS OIG:
“ 
About 1 million Medicare beneficiaries were diagnosed with opioid use disorder in 2020. Yet less than 16 percent of these beneficiaries received medication to treat their opioid use disorder, raising concerns that beneficiaries face challenges accessing treatment. Furthermore, less than half of the beneficiaries who received medication to treat their opioid use disorder also received behavioral therapy. These services may be provided in-person or via telehealth; however, the full extent to which beneficiaries use telehealth for behavioral therapy is unknown, as Medicare does not require opioid treatment programs to report this information. 
In addition, beneficiaries in Florida, Texas, Nevada, and Kansas were less likely to receive medication to treat their opioid use disorder than beneficiaries nationwide. Furthermore, Asian/Pacific Islander, Hispanic, and Black beneficiaries were less likely to receive medication than White beneficiaries. Older beneficiaries and those who did not receive the Part D low-income subsidy were also less likely to receive medication to treat their opioid use disorder.”
Read the report for recommendations to address this problem. 

About Covid-19

Pfizer to test a third dose of coronavirus vaccine in young children after two-dose regimen falls short: The companies reported that two doses of the pediatric vaccine failed in 2-, 3- and 4-year-olds to trigger an immune response comparable to what was generated in teens and older adults. The vaccine did generate an adequate immune response in children 6 months to 2 years old.
If three doses are successful at triggering a protective immune response, the companies expect to submit the data to regulators in the first half of next year.”

Moderna booster shot should provide ‘good level of protection’ against omicron, vaccine maker says: “A booster dose of Moderna’s vaccine — half the dose used in the original shots for adults — increased antibody levels against omicron by 37 times, the company said in a statement, citing preliminary data. 

Children exposed to covid can safely stay in class with in-school testing, CDC says: Students who have been exposed to the coronavirus can safely continue in-person learning if they are regularly tested for the virus at school, avoiding disruptive at-home quarantines, the Centers for Disease Control and Prevention said Friday.
The CDC released two studies that show the effectiveness of what’s known as ‘test-to-stay.’ School districts across the country have tried this strategy, though it is not widely used.”

CDC narrows use of J&J vaccine due to concerns about rare blood clots: “The Centers for Disease Control and Prevention accepted advice from a panel of experts to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines over the Johnson & Johnson jab, following growing concerns about rare blood clots. 
The advisers said Thursday that vaccines from Pfizer and Moderna should be preferred by all adults, who may be at greater risk for developing severe blood clots from the J&J vaccine than those under age 18. Some committee members said the J&J vaccine should remain available for people who prefer it.
The recommendation was prompted by the occurrence of a rare and sometimes fatal blood-clotting problem called thrombosis with thrombocytopenia syndrome (TTS).”

Omicron thrives in airways, not lungs; new data on asymptomatic cases“Compared to the earlier Delta variant, Omicron multiplies itself 70 times more quickly in tissues that line airway passages, which may facilitate person-to-person spread, they said. But in lung tissues, Omicron replicates 10 times more slowly than the original version of the coronavirus, which might contribute to less-severe illness.”

‘No evidence’ Omicron less severe than Delta, say UK researchers: “The Imperial College London research, which analysed UK infection data, casts doubt on the hopes of some experts, based on reports from medics in South Africa, that a change in the virulence of the new variant would limit pressure on health systems.”

Federal appeals court revives Biden's vaccine mandate for health workers in 26 states: “A federal appeals court has reinstated in 26 states a Biden administration vaccination mandate for health workers at hospitals that receive federal funding.
A three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans ruled (PDF) that a lower court had the authority to block the mandate in only the 14 states that had sued and was wrong to impose a nationwide injunction.”

Covid Data Tracker Weekly ReportFrom the CDC: “The United States recently surpassed 50 million COVID-19 cases and 800,000 deaths since the start of the pandemic. This week also marks the first anniversary of the first COVID-19 vaccination in the United States. In recent weeks, COVID-19 cases and hospitalizations have increased, with many parts of the country experiencing substantial or high levels of community transmission. These increases and the recent emergence of the Omicron variant highlight the importance of prevention strategies to help people stay safe and reduce the spread of the virus that causes COVID-19.”

 7 signs those new N95s at your physician practice might be fake: A reminder from the AMA, as we face a resurgence of Covid-19 cases.
According to the National Institute for Occupational Safety and Health (NIOSH), “here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for:

·       No markings at all on the filtering facepiece respirator.

·       No approval number on filtering facepiece respirator or headband.

·       No NIOSH markings.

·       NIOSH spelled incorrectly.

·       Presence of decorative fabric or other decorative add-ons.

·       Claims of approval for children—NIOSH does not approve any type of respiratory protection for children.

·       Filtering facepiece respirator has ear loops instead of headbands”

OSHA vaccine mandate penalties to start Jan. 10: “The Occupational Health and Safety Administration said Saturday that it would not issue citations tied to its coronavirus vaccination mandate before Jan. 10, so that companies have time to adjust to and implement the requirements.
The federal agency separately said there would be no citations of companies regarding its testing requirements before Feb. 9.”

Novavax’s COVID-19 Vaccine Gets WHO Emergency Use Listing“The listing was supported by two phase 3 studies — a 30,000-person trial in the U.S. and Mexico and a 14,000-person trial in the UK — in which the vaccine, NVX-CoV2373, showed strong efficacy and a positive safety and tolerability profile.
The company is currently evaluating its vaccine against the Omicron variant and is also developing a separate shot targeted specifically at the mutant strain.”

About the public’s health

Biden administration details push to finally rid the nation of millions of lead pipes: Half a dozen years after the water-contamination fiasco in Flint, Mich., shined a national spotlight on the persistent problem, the Environmental Protection Agency is set to write stricter standards for drinking water that would compel water utilities to dig up and replace lead lines from coast to coast.
Up to 10 million lead pipes still carry water to homes and businesses around the nation, the EPA estimates, carrying with them the risk of leaching the dangerous neurotoxin into drinking water. President Biden campaigned on removing all of the nation’s lead service lines as part of his plan to upgrade the nation’s aging infrastructure and alleviate the burden of pollution borne most heavily by poor and minority communities.”

 FDA eliminates key restriction on abortion pill as Supreme Court weighs case that challenges Roe v. Wade:  “The elimination of the rule by the Food and Drug Administration means abortion pills can be prescribed through telehealth consultations with providers and mailed to patients in states where permitted by law. Previously, the pills could not be mailed, though that regulation had been temporarily suspended by the FDA.”

About pharma

US judge strikes down Purdue's $4.5-billion opioid settlement: “A US federal judge late Thursday upended Purdue Pharma's opioid settlement, reversing a bankruptcy judge's earlier ruling, because of a provision that would shield the company's owners from facing litigation of their own. Judge Colleen McMahon for the Southern District of New York said that the $4.5-billion deal to resolve thousands of US opioid lawsuits should not go forward, arguing that the bankruptcy court lacked the authority to release members of the Sackler family from civil liability.”

Biogen slashes Aduhelm's price in half: Although the company defended the price as cost-effective, “Biogen reduced the price of Aduhelm, its controversial Alzheimer's drug, from an average annual cost of $56,000 to $28,200, the drugmaker said Dec. 20.
The change will take effect Jan. 1.” Now that the company has lost market credibility, how much lower can the price really go? 

About healthcare professionals

CMS Funding 1,000 New Residency Slots for Hospitals Serving Rural & Underserved Communities: “The Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) final rule with comment period establishes policies to distribute 1,000 new Medicare-funded physician residency slots to qualifying hospitals, phasing in 200 slots per year over five years. CMS estimates that funding for the additional residency slots, once fully phased in, will total approximately $1.8 billion over the next 10 years. In implementing a section of the Consolidated Appropriations Act (CAA), 2021, this is the largest increase in Medicare-funded residency slots in over 25 years. Other sections of the CAA being implemented further promote increasing training in rural areas and increasing graduate medical education payments to hospitals meeting certain criteria…
In allocating these new residency slots, CMS will prioritize hospitals with training programs in areas demonstrating the greatest need for providers, as determined by Health Professional Shortage Areas. The first round of 200 residency slots will be announced by January 31, 2023, and will become effective July 1, 2023.”

Doximety 2021 Physician Compensation Report: “Our findings show that average pay for doctors increased by 3.8% this year, which is up from an increase of 1.5% last year. Like last year, the increase did not outpace the rate of inflation. In 2021, the 12-month headline inflation rate was 6.2% [2] as measured by the Consumer Price Index (CPI). Thus, physicians on average experienced a decline in real income over the calendar year when compared with inflation.
In addition, our data showed that the gender pay gap among physicians was 28% this year. Male doctors currently earn over $122,000 more than their female counterparts.”
The report divides results by geography, subspecialty and sex; it is worth looking over.