Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From the Omicron front

Medpage Today offers an interesting discussion of the test to treat program.

The Wall Street Journal informs us

A new Covid-19 pill from Merck & Co. and Ridgeback Biotherapeutics LP has been more widely used than expected since rolling out late last year, though regulators and many doctors consider it a last resort. 

Many doctors and health officials anticipated a rival pill, Pfizer Inc.’s Paxlovid, would be the Covid-19 drug of choice. Paxlovid was found to be far more effective than Merck-Ridgeback’s molnupiravir in clinical trials, and regulators and guidelines recommended using Paxlovid if possible.

Prescriptions for the two antivirals have been running about equal since their authorization in December, however. The larger-than-expected use is a sign of the high demand for easy-to-use coronavirus treatments that can be taken at home, especially during surges like the recent Omicron wave.

Govexec tells us

Federal agencies are not restricted on the size of events they host, unless under certain conditions, according to new guidelines. 

The Biden administration’s Safer Federal Workforce Task Force issued updated and new guidance on March 11, most of which reflects the Centers for Disease Control and Prevention’s new framework released in late February. That framework “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” as CDC Director Dr. Rochelle Walensky said on a briefing call. 

There are no “restrictions on the size of agency-hosted in-person meetings, events, or conferences,” said one of the new “frequently asked question” prompts. “Should an agency intend to host a meeting, conference, or event that will be attended in-person by more than 50 participants at a facility in a county where the COVID-19 Community Level is HIGH, the agency should first seek the approval of its agency head or official to which this responsibility has been delegated, in consultation with the agency’s COVID-19 coordination team.” 

From the Rx coverage front –

BioPharma Dive reports good news

The Food and Drug Administration has approved AstraZeneca and Merck & Co.’s drug Lynparza for people with a genetic form of early breast cancer, a decision that could spur greater use of DNA testing in diagnosing and treating the disease.

Lynparza is already used to treat metastatic breast cancer in patients with so-called BRCA gene mutations. The new approval makes Lynparza available earlier in their disease, after surgery to remove a tumor and standard drugs like chemotherapy and radiation. People with cancers that are “HER2-negative” and at a high risk of relapsing are eligible for treatment.

The decision is based on the results of a large study published last year in The New England Journal of Medicine last year. In it, Lynparza reduced the risk of disease progression or death by 42% versus placebo after a median of 2.5 years of follow-up. Updated results show the drug cut the risk of death by about a third, a finding the companies will detail at a medical meeting on Wednesday.

The National Institutes of Health announced launching “a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines.” mRNA developers were working on HIV vaccines before the pandemic struck. Fingers crossed.

Healthcare Dive reports from Capitol Hill

Sen. Chuck Grassley (R Iowa) is urging the Federal Trade Commission to “find consensus” and vote again to launch a study into the business practices of pharmacy benefit managers, according to a letter he sent to FTC Chairwoman Lina Khan dated March 9.

“PBMs operate with little to no transparency, making it very difficult if not impossible to understand the flow of money in the prescription drug marketplace,” the Republican senator from Iowa said in his letter, nodding to the bipartisan consensus for such an examination.

Grassley urged the commissioners to come up with a more targeted focus for the study and suggested narrowing a review to the impact on consumers and their out of pocket costs.

From the patient safety front, Beckers Hospital Review explains

Staffing shortages are the top threat to patient safety in 2022, according an annual report on patient safety concerns from ECRI, an organization that conducts independent medical device evaluations, published March 14. 

Researchers identified the top threats to patient safety by analyzing a wide range of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI. 

Ten top patient safety concerns this year: 

1. Staffing shortages

2. COVID-19 effects on healthcare workers’ mental health

3. Bias and racism in addressing patient safety 

4. Vaccine coverage gaps and errors

5. Cognitive biases and diagnostic error

6. Nonventilator healthcare-associated pneumonia 

7. Human factors in operationalizing telehealth

8. International supply chain disruptions

9. Products subject to emergency use authorization

10. Telemetry monitoring 

From the mental healthcare front, the Department of Health and Human Services announced

A new U.S. Department of Health and Human Services (HHS) study published in the American Medical Association’s journal JAMA Pediatrics  reports significant increases in the number of children diagnosed with mental health conditions. The study, conducted by the Health Resources and Services Administration (HRSA), finds that between 2016 and 2020, the number of children ages 3-17 years diagnosed with anxiety grew by 29 percent and those with depression by 27 percent. The findings also suggest concerning changes in child and family well-being after the onset of the COVID-19 pandemic.

No bueno.

Weekend Update

From Capitol Hill, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Healthcare Dive reminds us that the Healthcare Information and Management Systems Society will hold its annual conference in Orlando, Florida, this week. In addition, Healthcare Dive notes several headliner presentations planned for that conference.

From the health equity front, the Wall Street Journal reports

The fatal overdose rate among Black people surpassed that for white people in the first year of the pandemic, as an increasingly lethal drug supply and Covid-19’s destabilizing effects exacted a heavy toll on vulnerable communities in the U.S.

The proliferation of the potent opioid fentanyl, and a pandemic that has added hazards for people who use drugs, are driving new records in U.S. overdose deaths, and Black communities have been hit especially hard. Black people often have uneven access to healthcare including effective drug treatment, putting them at high risk, researchers and public-health experts say. 

The most recent full-year of federal data, through 2020, shows the rate of drug deaths among Black people eclipsed the rate in the white population for the first time since 1999, researchers at the University of California, Los Angeles recently demonstrated.

What is an effective treatment for substance use disorder? The Journal adds

Researchers at the University of Michigan examining outpatient visits for substance use in recent years found white patients were three to four times as likely as Black patients to receive buprenorphine, a prescription medication to treat opioid dependence that is more readily available to people with health insurance or the means to pay out of pocket.

Health providers are more likely to direct Black patients to methadone, which is delivered by highly regulated opioid-treatment programs that often require daily visits to obtain the medication, researchers have found.

According to Sam Quinones’s books on the opioid and fentanyl problems plaguing our country, drug dealers hang out at methadone clinics.

On a related note, The Psychiatric Times informs us

The positive implications for screening for and treating individuals with SUDs are vast, from preventing HIV and hepatitis in injection-drug users to improving patients’ physical health, mental health, employment, and housing.

Elisa Gumm, DO, who is presenting on “Screening for Addiction in a 20-Minute Appointment” at the “Psychiatry for Non-Psychiatrists: The University of Arizona Update in Behavioral Medicine for Primary Care” conference, stated that “offering addiction interventions at every level reduces the overall costs to the person and society

Also, the New York Times reports on today’s front page about the serious logistical problems facing the federal and state governments as they seek to launch the new 988 suicide hotline on July 1, 2022.

Fierce Healthcare discusses the advantages of using teledentistry with rural patients.

Teledentistry enables rural access to care, lowers costs and helps provide preventive services, a new study has found. 

The CareQuest Institute looked at data for patients in Oregon and Washington. The study included data from more than 60,100 individuals who had a dental visit either in person or through teledentistry in the second half of 2020.

Most (79%) patients with a teledentistry visit had a follow-up visit sometime in 2021, the vast majority of which were in person. Most (60%) had this visit within three weeks of their teledentistry visit, which primarily consisted of diagnostic and restorative services. 

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, the Senate has adjourned until Monday March 7 after setting another cloture vote on the Postal Reform Act of 2022 (HR 3076) for Monday at 5:30 pm. While the FEHBlog is not a Senate procedure expert, it appears that another cloture vote is required because a minor Senate amendment was filed after the first cloture vote. Postal reform must be getting real because the Wall Street Journal posted an account of the decade-long effort to pass this legislation today.

From the Omicron front, the FEHBlog’s favorite part of the President’s new strategy was explained by the White House Covid czar yesterday:

Pfizer’s pill {Paxlovid] is a gamechanger — 90 percent effective at keeping people out of the hospital.

We collaborated with Pfizer to accelerate development of the pill.  And we’ve ordered 20 million courses.

As the President announced last night, Pfizer worked overtime to further accelerate delivery.  This month alone — the month of March — we’ll have 1 million of these treatment courses available.  And in April, that number will more than double.

To ensure these lifesaving treatments are easily accessible, the President’s Plan launches a new “Test to Treat” initiative to provide individuals access to testing and treatment for free, all in one stop. 

Hundreds of one-stop sites will open across the country this month, located at local pharmacy clinics, community health centers, long-term care facilities, and veterans’ health centers.

Marketwatch adds today that “CVS Health Corp., the Walgreens Boots Alliance Inc., and Walmart Inc. said they will participate in the test-to-treat initiative, a new program that allows someone who has tested positive for the virus to get antiviral pills during the same visit at no cost.”

Covid treatment costs were astronomical because care principally was given in hospitals and other healthcare facilities, creating a major burden on the healthcare system. Facilitating the use of Flonase for Covid will avoid the vast majority of those hospitalizations, thereby lowering healthcare costs.

Speaking of testing, the Wall Street Journal reports that

Manufacturers are developing new types of at-home tests, including for flu and strep throat, aimed at consumers who are increasingly monitoring and managing their own health through fitness apps and smartwatches.

Boulder, Colo.-based fertility company MFB Fertility Inc. received clearance from the U.S. Food and Drug Administration in February 2020 for its Proov test, designed to help women measure their hormone levels and to know when in a given month they are most likely to become pregnant. A typical kit includes 20 testing strips, allowing a woman to test daily, which the company said would be tough to achieve through visits to a doctor’s office.

Amy Beckley, the company’s chief executive, said the rise of at-home Covid-19 tests over the past year has made it much easier for people to understand her product.

“All of a sudden, home diagnostics and home testing became a thing,” she said.

Mobihealth News reported last June

The U.S. Air Force has inked a $1.3 million deal with MFB Fertility in order to provide military members and their partners the former’s home fertility tests.

The Air Force’s AFWERX office will invest in Proov, an at-home ovulation test with FDA clearance. The test works by measuring Pregnanediol Glucuronide (PdG), the urine metabolite of progesterone, which is released by the ovary after ovulation. High levels of PdG over multiple days can confirm that successful ovulation took place.

The contract will provide free Proov kits to Air Force couples upon request and connect them to fertility specialists.

Two cool innovations.

From the healthcare policy front —

  • The White House released a fact sheet on steps underway to address the Nation’s opioid epidemic.
  • The Associated Press reports on the President’s mental healthcare policy proposals made in Tuesday’s State of the Union address. For example, under the President’s plan, “Health insurance plans would have to cover three mental health visits a year at no added cost to patients.” I suggest that the Administration consider the fact that most employers offer employee assistance plans that already offer two or three free mental health therapy visits. The overcomplicated federal mental health parity law fails to look at the big picture.

From the diabetes front —

  • The AMA offers six tips for screening patients for pre-diabetes. Many of the tips also could be applied by health plan case managers and coaches.
  • The American Diabetes Association delves into the relationship between diabetes and kidney disease.

From the litigation front, Reuters reports

The Sackler family owners of Purdue Pharma LP reached a deal with a group of attorneys general to pay up to $6 billion in cash to resolve widespread litigation alleging that they fueled the U.S. opioid epidemic, bringing the OxyContin maker closer to exiting bankruptcy.

The attorneys general for eight states and the District of Columbia, who had blocked a previous settlement that included a $4.3 billion cash payment, announced the deal after weeks of mediation with the Sacklers.

The family agreed to pay at least $5.5 billion in cash, which will be used for abating a crisis that has led to nearly 500,000 U.S. opioid overdose deaths over two decades.

The value of the deal could grow as the family members sell additional assets.

U.S. Bankruptcy Judge Robert Drain must approve the deal, which protects the Sacklers from civil lawsuits. Purdue requested a March 9 hearing for Drain to review the agreement.

From the Rx coverage front, Biopharma Dive reports

Civica is making plans to offer three versions of insulin that can be sold at dramatically lower prices than today’s alternatives, targeting a need highlighted by President Joe Biden during this week’s State of the Union Address.

The nonprofit company, created by hospital systems and philanthropies to address drug shortages, said Wednesday it will recommend pricing of no more than $30 for the vials it produces. Name-brand versions can currently cost 10 times that amount at cash prices.

Civica announced an ambitious timeline, projecting that the first product — designed to be interchangeable with Sanofi’s Lantus — would be available as soon as early 2024. The company also aims to manufacture cheaper versions of Eli Lilly’s Humalog and Novo Nordisk’s Novolog, in both vials and pre-filled pens.

Also the Institute for Clinical and Economic Review (“ICER”) announced

it will assess the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), phentermine / topiramate (Qsymia, Vivus Pharmaceuticals), liraglutide (Saxenda, Novo Nordisk), and naltrexone/bupropion (Contrave, Currax Pharma) for the treatment of obesity. 

The assessment will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in September 2022, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

ICER’s website provides timelines of key posting dates and public comment periods for this assessment.

Friday Stats and More

Based on the Centers for Disease Control’s (CDC) Covid Data Tracker website and using Thursday as the first day of the week, here are the FEHBlog’s charts of weekly new Covid cases and deaths from the 27th week of 2021 through the 8th week of 2022, both of which are plummeting

Here’s the FEHBlog chart of weekly Covid vaccinations distributed and administered from the 51st week of 2020 through the 8th week of 2022iew

Here are links to the CDC’s weekly review of its Covid statistics and its weekly Fluview. The Covid news is significant

CDC is updating the way it monitors COVID-19’s impact on our communities. Widespread availability of vaccines and testing, advances in treatments, and increasing levels of immunity in the population through vaccination or previous infection have moved the COVID-19 pandemic to a new phase. While we can’t prevent all cases of COVID-19, we can continue to limit the spread and protect those who are most at risk of severe illness.

Given this new phase of the pandemic, CDC is launching a new tool to monitor COVID-19 Community Levels. Each county’s COVID-19 Community Level is ranked as low, medium, or high (find your county’s level). The COVID-19 Community Level map where you can find your county’s level will be updated regularly with new data.

Medscape adds

As of now, most counties in the country fall into either low-risk or medium-risk categories, said Greta Massetti, PhD, of the COVID-19 Response Incident Management Team.

Those counties, “representing 70 percent of Americans, are in low to medium community levels,” she said. “We continue to see indicators improve in many counties.”

A total of 23% of U.S. counties fall into the low-risk group, and 39% are medium-risk, Massetti said.

But, Walensky said, these guidelines could change at any time if numbers begin moving in the wrong direction.

Also, from the policy front

Medscape tells us and as evidenced by the new CDC approach

The White House has begun a sweeping overhaul of its COVID-19 strategy as the U.S. moves out of pandemic crisis mode and into a more manageable phase, according to ABC News.

The new strategy is expected to acknowledge that the coronavirus is becoming a less urgent threat to Americans overall due to access to vaccines, testing, and therapeutics.

Insurance News Net informs us about AHIP’s 2022 priorities as identified by its President Matt Eyles:

  1. Affordable coverage, improved access. Addressing the underlying cost drivers of care. Ending pharma monopolies. Addressing hospital and physician group consolidation. Pushing back on restrictions on medical management.
  2. Improving health equity. Ensuring everyone has an equal opportunity to thrive and achieve their best possible health. Expanding initiatives to provide health care opportunities to underserved areas and populations. Providing COVID-19 vaccine outreach to at-risk older Americans. Providing outreach in a culturally competent manner to various ethnic groups.
  3. Post-pandemic health care. AHIP will develop a post-pandemic road map to improve health care. AHIP is working to maintain coverage for those who were eligible for coverage under Medicaid or the Affordable Care Act during the public health emergency so that they will continue to have coverage when the emergency ends.
  4. Improving competition and choice. Maintain a competitive private health insurance market.

Worthy priorities, indeed.

Fierce Healthcare tells us about the American Medical Association’s President’s speech on the AMA priorities for improving U.S. healthcare and readiness for future pandemics.

From the avoiding low-value care front, Medscape reports

Low-value healthcare services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association (AHA) says in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors note.

Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States, they note.

The statement was published online February 22 in Circulation: Cardiovascular Quality and Outcomes.

From the mental healthcare front, Health Affairs Forefront discusses how

This July, the US model for responding to individuals experiencing a mental health crisis is scheduled for a much-needed change. The 988 number is a three-digit, national mental health crisis hotline that was mandated by the federal government in October 2020 with an official nationwide start date on July 16, 2022. * * *

The 988 hotline holds incredible promise toward decriminalizing the response to mental health emergencies. Currently, if an individual is experiencing a mental health crisis, they, their caregivers, and bystanders have few options beyond calling 911. As a result, roughly one in 10 individuals with mental health disorders have interacted with law enforcement prior to receiving psychiatric care, and 10 percent of police calls are for mental health emergencies. * * *

Ideally, the new 988 number would activate an entirely different cascade of events. An individual in crisis, their family member, or even a bystander will be able to immediately reach a trained crisis counselor who can provide phone-based triage, support, and local resources. If needed, the counselor can activate a mobile mental health crisis team that will arrive on site to de-escalate; provide brief therapeutic interventions; either refer for close outpatient follow up or transport the individual for further psychiatric evaluation; and even offer food, drink, and hygiene supplies.

That’s an interesting perspective. Health plans should plan to publicize the 988 number this summer.

From the chronic disease front, Health Payer Intelligence uses a recent CMS report on healthcare spending to identify the ten most expenses chronic diseases in our country.

From the Rx coverage front, Healthcare Dive reports

The Federal Trade Commission is calling on the public to submit feedback on how pharmacy benefit managers’ business practices are affecting patients, pharmacies and employers.

The agency is seeking to gather a wide range of information and comments on pharmacy benefit managers, including how they affect drug prices, access, contract terms, rebates, fees, steering methods, conflicts of interest and consolidation, according to the request for information released Thursday.

Members of the public can comment through April 25. The information the FTC collects will enable the agency to “study a wide array of PBM business practices and issues and will help inform the agency’s policy and enforcement work,” the regulator said in a statement.

Finally in litigation news, the Wall Street Journal informs us

Pharmaceutical company Johnson & Johnson and three of the nation’s biggest drug distributors have agreed to move forward with a landmark settlement with a majority of states, bringing thousands of lawsuits over the opioid epidemic closer to the finish line. 

Drug distributors AmerisourceBergen Corp. , Cardinal Health Inc. and McKesson Corp. would pay a total of $19.5 billion to 46 states over 18 years, according to the companies. Johnson & Johnson said it would pay $5 billion to 45 states. 

The global settlement was first announced last summer. It was given final approval by the companies after a threshold number of state and local governments agreed to participate and currently amounts to roughly $25 billion.

The settlement is the largest to date from more than 3,000 lawsuits brought by states, local governments, Native American tribes, hospital groups and others alleging that companies from pharmaceutical manufacturers to distributors and pharmacies flooded areas with pills and created the opioid epidemic, ultimately forcing communities to spend millions of dollars responding to the crisis. 

Let’s hope that the settlement funds are used to end our other national epidemic, substance use disorder.

Midweek update

Photo by Josh Mills on Unsplash

From the Omicron front —

MedCity News reports

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster. 

This news bears similarities to the reports about the Novavax Covid vaccine already submitted to the Food and Drug Administration for emergency use authorization.

The American Hospital Association informs us

The Food and Drug Administration yesterday listed all over-the-counter COVID-19 diagnostic tests authorized for home use, including links to home use instructions for each test.

Fierce Healthcare adds

Walmart has administered tens of millions of COVID-19 vaccines to date, with 80% delivered in medically underserved communities, the retail giant announced Wednesday.

The company released a report (PDF) looking back at its progress in providing vaccines over the course of 2021. Cheryl Pegus, M.D., executive vice president of health and wellness at Walmart, told Fierce Healthcare the company has focused on connecting with people who may not otherwise have been able to get the shot.

From the health equity front —

The American Hospital Association tells us

The U.S. maternal mortality rate increased to 23.8 deaths per 100,000 live births in 2020 from 20.1 in 2019 as rates for Black and Hispanic women increased, according to data released today by the Centers for Disease Control and Prevention. The maternal mortality rate for Black women was nearly three times the rate for white women. Mortality rates increased with maternal age, with the rate for women aged 40 and over nearly eight times higher than the rate for women under 25.

The AHA’s Better Health for Mothers and Babies initiative offers resources to help hospitals and health systems eliminate maternal mortality and address health disparities for mothers and babies. 

What can be more tragic than a baby losing a mother?

Beckers Payer Issues adds from the mental health perspective

Work-sponsored health plans aren’t addressing the growth of loneliness, which leads to employees missing work and decreased productivity, according to data from Cigna’s Loneliness Index shared with Becker’s

The data, which is slated to be published in the Journal of Organizational Effectiveness: People and Performance, surveyed nearly 6,000 employees between July 16 and Aug. 2, 2019. 

Six insights:

1. The widespread presence of loneliness affected 3 in 5 (62 percent) adults before the COVID-19 pandemic. Feelings of loneliness play key roles both in employee health and work performance, according to the study.

2. On average, preventable, stress-related absences caused lonely employees to miss about five more work days than their counterparts who did not identify as lonely.

3. Employees who reported higher levels of loneliness were almost twice as likely to consider quitting their current job than employees who were less lonely. 

4. The study estimates that absenteeism and productivity losses tied to preventable loneliness cost employers $154 billion each year. 

5. The study said work-based factors like communication, work-life balance and social companionship play key roles in determining employee loneliness. Personal resilience and a feeling of connection outside of the workplace also play a role. 

6. Employers looking to combat employee loneliness should consider actions that hit on these factors, including flexible work hours, email “blackout” periods and forming employee resource groups.

From the Black History Month department, Everywell, an at-home testing service, celebrates ten Black pioneers who improved healthcare in our country. Bravo.

From the U.S. healthcare front, Healthcare Finance News reports

Including federal government support, national health spending grew by 3.4% in 2021, according to new data released by Altarum.

This growth in spending, the analysis found, reflected the fact that support from the federal government was strong in 2020, likely in response to the recession caused by the COVID-19 pandemic, and was lower in 2021.

Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover.

From the healthcare business front —

Healthcare Dive informs us

Despite worries that demand for telehealth could fall as the U.S. emerges from the COVID-19 pandemic, virtual care giant Teladoc beat Wall Street expectations with its 2021 financial results, and issued strong future growth projections Tuesday.

The New York-based vendor posted revenue of more than $2 billion in 2021, 86% higher than in 2020. Total visits were up 38% to 15.4 million, and Teladoc closed out the year with 53.6 million U.S. paid members, up just slightly from the year prior.

Beckers Hospital Review identifies 92 U.S. health systems with CMS-approved “hospital at home” programs.

Managed Healthcare Executive tells us

Tired of grappling with the rising costs and poor quality of healthcare, a coalition of major healthcare purchasers is taking things into its own hands, establishing a company that is designing healthcare products to meet its members’ needs. “There’s an incredibly high frustration level among buyers of healthcare,” says Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health (PBGH) in San Francisco. 

The nonprofit PBGH represents almost 40 large private employers and public entities that together spend $100 billion each year on healthcare services for more than 15 million Americans and their families. PBGH members include Microsoft, Walmart and American Airlines.

The decision to create the company, Emsana Health, was made about two years ago, with the initial focus on “really understanding the needs on a deep level,” Mitchell says. The company officially launched in the fall, and its first venture is setting up a pharmacy benefit manager (PBM), EmsanaRx, which went started operating on Jan. 1.

Finally, in a troubling tidbit, the Wall Street Journal reports

U.S. life insurers, as expected, made a large number of Covid-19 death-benefit payouts last year. More surprisingly, many saw a jump in other death claims, too.

Industry executives and actuaries believe many of these other fatalities are tied to delays in medical care as a result of lockdowns in 2020, and then, later, people’s fears of seeking out treatment and trouble lining up appointments.

Some insurers see continued high levels of these deaths for some time, even if Covid-19 deaths decline this year.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Capitol Hill front —

The Wall Street Journal reports

Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. * * *

[Senate Minority Leader Sen. Mitch] McConnell said Tuesday that he expected there to be some amendment votes in conjunction with the vote on the so-called continuing resolution. “I think it will all be worked out,” he said. “There’s no danger of a government shutdown.”

The House of Representatives held a pro forma, the four-minute-long session this morning at which

[The] Clerk notified the House that she had received the following message from the Secretary of the Senate on February 14, 2022, at 6:30 p.m.: That the Senate agreed to return the papers to the House of Representatives at their request for H.R. 3076 [the Postal Reform Act of 2022] * * *.

The House is not scheduled to resume floor voting until February 28 and the Senate will be on a State work period next week so Congressional passage of this bill may not occur until next month.

FInally Roll Call reports

The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

Califf’s confirmation means the Biden administration has a permanent FDA commissioner during the COVID-19 pandemic after 13 months with longtime agency official Janet Woodcock acting as its leader.

Califf needed bipartisan support to cross the finish line. Retiring Sens. Patrick J. Toomeyof Pennsylvania and Roy Blunt of Missouri joined four Republicans who sit on the Health, Education, Labor and Pensions Committee to confirm Califf.

From the Omicron front, the Wall Street Journal offers interesting commentary from Dr. Marc Siegal about the Novovax vaccine which is the subject of an emergency use authorization at the Food and Drug Administration.

The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.

There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.

From the health equity front, Health Payer Intelligence discusses a Northeast Business Group on Health report on strategies for making progress on resolving inequities created by social determinants of health. Check it out.

In a similar vein, the Agency of Healthcare Research and Quality blog post on integrating patient-generated health data into electronic health records.

The 63-year-old patient has hypertension. With encouragement from his family, he checks his blood pressure daily using a digital blood pressure monitor. And thanks to advances in digital technology, he saves each reading on a mobile application whether he’s at home, at work, or on vacation.

What is the reward for his persistence? With his health data easily integrated into his electronic health record, his primary care doctor has a fuller picture of his health—one that is not limited to the traditional snapshot taken in an exam room. Using that data, he and his physician can have more informed conversations about treatment options and next steps.

While this scenario accurately recognizes that today’s patients can easily collect their own health data outside of the clinical setting, many ambulatory care practices lack the technical infrastructure, functional workflows, workforce capacity, and training to support the intake and use of patient-generated health data (PGHD).

With those challenges in mind, AHRQ has released a new guide on increasing the use of PGHD, one that provides practical tools for ambulatory care practices to implement PGHD programs and improve patient outcomes. It includes tips, ideas, and learning activities to let users tailor solutions to their needs. To our knowledge, this is the first practical guide that includes detailed considerations and steps for implementing a PGHD program.

The AHRQ guide may be helpful to health plan case managers, too.

From the tidbits department

  • Roll Call and Fierce Healthcare offer different takes on the public comments submitted on the Centers for Medicare Services controversial proposed national coverage deterimination on Biogen’s Alzheimers Disease drug Aduhelm. A final decision is expected in April.
  • The CDC encourages people with pre-diabetes to become heart health role models.

Cigna’s Evernorth is adding Monument’s virtual care services to its behavioral health network, the insurer announced Tuesday.

The platform is now available to all Evernorth clients and to Cigna members in employer plans or Affordable Care Act marketplace plans in 20 states.

Monument offers an evidence-based, virtual treatment program for alcohol use disorder. Evernorth said in the announcement that alcohol use has been on the rise for the past several decades, and that some 60% of people have reported higher alcohol intake under the pandemic.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill —

Govexec reports that earlier today the House of Representatives passed the Postal Reform bill (HR 3706) by a bipartisan 342 to 92 vote. The bill now heads over the the Senate. Govexec adds “Sen. Gary Peters, D-Mich., who chairs the Homeland Security and Governmental Affairs Committee and authored the companion legislation in the Senate, sounded an optimistic note for the bill’s fate in his chamber. ”

The bill would create a Postal Service Health Benefits Program within the FEHB Program beginning in 2025. The PSHBP would feature tightly integrated coverage with Medicare for its annuitants over age 65.

Roll Call informs us that

The House passed a stopgap appropriations bill Tuesday evening to extend current federal agency funding rates through March 11 as Democrats and Republicans continue to trade offers on topline spending levels for the fiscal year that began Oct. 1.

Both sides claim they’re “close” to a framework deal on the fiscal 2022 omnibus and predict this latest continuing resolution, the third one this fiscal year, will be the last stopgap. The previous CR is set to expire Feb. 18. 

Senate Majority Leader Charles E. Schumer said in floor remarks Tuesday morning that his chamber will take up the stopgap measure “quickly” after House passage, “in time before the Feb. 18 deadline.” The House vote was 272-162, indicating likely bipartisan support in the Senate as well.

Fierce Healthcare tells us

A bipartisan group of senators is crafting a package that tackles several barriers to mental health access, with a major emphasis on pay parity between behavioral and physical health and furthering telehealth use.

The Senate Finance Committee Chairman Ron Wyden, D-Oregon, announced the contours of the mental health legislative package during a hearing Tuesday on youth mental health. Wyden said the goal is to get together a bipartisan bill by the summer.

The anticipated bill would be a gold mine for lawyers unless Congress also simplifies the existing parity standards.

From the Omicron front —

The Wall Street Journal advises

You’ve been exposed to Covid-19 more times than you can count. And yet somehow you’ve never tested positive. Could all these close encounters with Covid-19 be enhancing your immune response to it? The answer isn’t clear-cut, scientists say.

Your immune system probably benefits only if you get infected, many scientists say, because a near miss probably won’t have put enough virus in your body to meaningfully rev up your defenses. You can benefit from an asymptomatic infection that you didn’t realize you had, or a case that was too low-level to show up on a rapid test.

The only safe way to build immunity is vaccination, as any exposure to Covid-19 comes with a risk of serious illness, hospitalization or death. Avoiding infection is still important, but if you are exposed, there are circumstances where you might benefit if you already have antibodies, some scientists say.

Medscape reports

People who have had COVID-19 have an increased risk for and 12-month burden of cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, told theheart.org | Medscape Cardiology. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Ruh roh.

From the synthetic opioid epidemic front, AP reports

The U.S. needs a nimble, multipronged strategy and Cabinet-level leadership to counter its festering overdose epidemic, a bipartisan congressional commission advises.

With vastly powerful synthetic drugs like fentanyl driving record overdose deaths, the scourge of opioids awaits after the COVID-19 pandemic finally recedes, a shift that public health experts expect in the months ahead.

“This is one of our most pressing national security, law enforcement and public health challenges, and we must do more as a nation and a government to protect our most precious resource — American lives,” the Commission on Combating Synthetic Opioid Trafficking said in a 70-page report released Tuesday.

The report envisions a dynamic strategy. It would rely on law enforcement and diplomacy to shut down sources of chemicals used to make synthetic opioids. It would offer treatment and support for people who become addicted, creating pathways that can lead back to productive lives. And it would invest in research to better understand addiction’s grip on the human brain and to develop treatments for opioid use disorder.

From the telehealth front —

According to mHealth Intelligence

Most [77%] infectious disease (ID) patients were open to using virtual care after they were informed about the toll in-person care took in terms of time, money, and travel, according to a survey conducted by Washington University and published in Open Forum Infectious Diseases.

Although patients are typically accustomed to the setting in which they receive care, information provided about virtual care can change their perspective, the new research shows.

The survey polled patients 18 years old and older who reside 25 or more miles away from their ID clinic. The goal was to acquire information regarding travel distance and time, money spent, and carbon dioxide emissions.

Beckers Hospital Review adds “Amazon Care’s virtual health services are now available nationwide, and its in-person services will be rolled out in more than 20 new cities in 2022, Amazon said Feb. 8 in a post on its website.” Amazon Care also offers in-person care in “Seattle, Baltimore, Boston, Dallas, Los Angeles, Washington, D.C, Austin, Texas, and Arlington, Virginia. This year, the company plans to bring in-person care services to more than 20 additional cities including New York City, Chicago, Miami and San Francisco, according to the post.”

From the healthcare business front

  • Biopharma Dive reports on Pfizer’s zesty 4th quarter 2021 financial report
  • Becker’s Payer Issues reports on health insurer Centene’s positive 4th quarter 2021 results.

From the rankings department, Beckers Hospital Review notes

“Healthgrades has recognized 250 hospitals nationwide for exceptional care via its America’s Best Hospitals awards released Feb. 8. Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”

and

Three companies dominate the pharmacy benefit manager market, accounting for 79 percent of all prescription claims in 2020, according to data from Health Industries Research Companies, an independent, non-partisan market research firm. A breakdown of PBM market share, by total adjusted prescription claims managed in 2020:

1. CVS Caremark: 34 percent

2. Express Scripts: 24 percent

3. OptumRx (UnitedHealth): 21 percent

4. Humana Pharmacy Solutions: 8 percent

5. Prime Therapeutics: 6 percent

6. MedImpact Healthcare Systems: 5 percent

7. All other PBMs: 3 percent

Finally, from the good news department, the Wall Street Journal reports

The [CDC’s] new births data, released Monday along with final data for 2020, show the pandemic has had a more muted impact on childbearing than expected. The economists Melissa Kearney and Phillip Levine in December released calculations showing the pandemic led to 60,000 missing births from October 2020 through February 2021. Earlier in the pandemic, they predicted the health crisis and economic uncertainty would lead to 300,000 to a half million fewer births last year.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s chart of weekly new Covid cases from the 27th week of 2021 through the 5th week of this year:

The Omicron surge is subsiding. The CDC’s weekly interpretation of its COVID statistics indicates that

COVID-19 cases and hospitalizations are continuing to decline across the United States. As of February 2, 2022, cases are down 53.1% from their peak on January 15. However, community transmission is still high nationwide.

Unfortunately Covid-related deaths, a lagging indicator, continue to rise:

Here’s the FEHBlog’s chart of weekly Covid vaccinations administered and distributed from the 51st week of 2020 through the 5th week of 2022.

The pace of COVID vaccinations is slowing again. 212.5 million out of 303 million Americans (net of 23.6 million children under 5 years old) are fully vaccinated and of that cadre, 89.3 million have been boostered.

The American Medical Association offers seven reasons why parents should get their kids ages 5 to 11 vaccinated against Covid.

Also today the CDC’s Advisory Committee on Vaccination Practices unanimously ratified the FDA’s decision to award full marketing approval to the Moderna mRNA vaccine Spikevax for use with adults age 18 and older.

For the hardcore Covid statistics folks check out this tidbit from the CDC’s weekly interpretative report

Wastewater (sewage) surveillance is a promising tool for tracking the spread of SARS-CoV-2, the virus that causes COVID-19. Many people with COVID-19 shed the virus in their feces, so testing wastewater can help us find COVID-19 in communities. Wastewater testing has been successfully used as a method for detection of other diseases, such as polio. Wastewater surveillance results can provide an early warning of increasing COVID-19 cases and help communities prepare.

On February 3, 2022, COVID Data Tracker released a Wastewater Surveillance tab, which tracks SARS-CoV-2 levels in sewage at more than 400 testing sites across the country. This marks the first time CDC’s wastewater surveillance data is available for download. See “A Closer Look” below for more information about this method of data collection.

From the Covid testing mandate front, the Affordable Care Act regulators issued ACA FAQ 52 late this afternoon. The regulators use this FAQ to provide helpful clarifications to the mandate. Check it out.

From the Covid treatment front, Medscape tells us that

A little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.

Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said.

“We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”

The CDC’s weekly Fluview report summarizes the flu situation as follows: “Influenza activity has decreased in recent weeks, but sporadic activity continues across the country.”

From the Postal reform front, Federal News Network reports that

The Postal Service’s best shot at a long-term legislative reform in recent years is finally moving ahead in Congress next week.

The House expects to vote on the Postal Service Reform Act next week. The House Oversight and Reform Committee approved the legislation last May.

Notably, the most recent version of the bill now has the support of the National Active and Retired Federal Employees (NARFE), which raised significant concerns about an earlier version.

NARFE, in a letter of support Friday, said an earlier version of the bill contained “onerous provisions” that could have increased health insurance premiums for all non-postal federal employees and retires.

The earlier version of the bill, the association added, would have also required current postal retirees to pay additional premiums for mostly duplicative health insurance coverage through Medicare.

Moreover, this afternoon, the Congressional Budget Office released its report on the House Rules Committee Print 117-32 for H.R. 3076, the Postal Service Reform Act of 2022. The FEHBlog does not see any showstoppers in that CBO report. The House Rules Committee has scheduled a hearing on this bill for Monday at 2 pm ET. You can read the current version of the bill here.

Finally, Healthcare Dive reports that

Congress appears poised to work on a bipartisan mental health and substance misuse package this year, following a series of hearings this week stressing the need to boost the workforce, insurer benefits and telehealth access.

Legislators also seemed to support giving federal departments more power to force health insurers to comply with parity laws, following a report in late January finding widespread inequities between mental and medical benefits in the U.S. that sent physician groups up in arms.

That, dear readers, is a big bowl of wrong because the outrage stems from the “non-quantitative treatment limit” mental health parity standard set by the Obama era regulation, not the original law. That standard, in the FEHBlog’s view, is amorphous. The FEHBlog favors mental health parity but please Congress don’t make the standard impossible to achieve consistently. Keep it simple.

Midweek update

Happy Groundhog Day! The Pittsburgh Post Gazette informs us that “There will be six more weeks of winter, Punxsutawney Phil predicted as he emerged from his burrow Wednesday morning to perform his Groundhog Day duties.”

From the White House, we have the President’s fact sheet on his Cancer Moonshot initiative. Federal Times also has a report on today’s announcement.

A STAT News article on cancer markers suggests that the President’s timing may be right

Back in 2000, when President Clinton called a tie in the race to map the human genome, scientists forecasted a medicinal revolution, one in which scientists could ferret out the genetic roots of every known cancer and match patients with personalized treatments.

That did not happen, for reasons of biological complexity, technological immaturity, and perhaps a little scientific hubris. But after two decades of mapping the kaleidoscopic details of human DNA, researchers believe they finally have the tools and techniques to live up to those lofty promises.

“It’s almost like back to the future,” said Anna Barker, an oncologist who serves as chief strategy officer at the Ellison Institute for Transformative Medicine of USC. “Where we would like to have been 21 years ago is where we are now.” * * *

But many cancers don’t fit neatly into the field’s existing paradigm, said Suzanne Topalian, professor of surgery and oncology at Johns Hopkins University School of Medicine. Improving outcomes for those tumors will rely on multidimensional biomarkers, measurements that can take a systematic look at how cancer evolves rather than providing a snapshot.

To Barker, the field’s next major challenge is to find better biomarkers for “the big killers,” diseases including pancreatic cancer and glioblastoma.

“These are the cancers that — what are the unknown unknowns here? What are we missing?” she said. “We can’t seem to detect them early enough to stop them.”

From the opioid epidemic front, the National Institutes of Health informs us that

A new study of intentional drug overdose deaths, or suicides by an overdose of a medication or drug, found an overall decline in recent years in the United States, but an increase in young people aged 15-24, older people aged 75-84, and non-Hispanic Black women. The study also found that women were consistently more likely than men to die from intentional drug overdoses, with the highest rates observed in women ages 45 to 64. In addition, factors such as time of year, length of day, and day of the week appeared to be associated with intentional overdose death rates. The study published today in the American Journal of Psychiatry and was led by investigators at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

Nearly 92,000 people died from drug overdoses overall in the U.S. in 2020. This represents the largest increase ever recorded in a calendar year and reflects a nearly five-fold increase in the rate of overdose deaths since 1999. About 5% to 7% of these overdose deaths are recorded as intentional. Because it can be difficult to determine whether overdose deaths are intentional, the actual numbers are likely even higher. Many people who have a substance use disorder also develop other mental illnesses, such as mood and anxiety disorders, which are independently associated with increased suicide risk. In addition, many people who are diagnosed with other mental illnesses are often diagnosed with a substance use disorder, emphasizing the need to address co-occurring mental health conditions holistically. 

“The distinction between accidental and intentional overdose has important clinical implications, as we must implement strategies for preventing both,” said Nora Volkow, M.D., senior author on the study and director of NIDA. “To do so requires that we screen for suicidality among individuals who use opioids or other drugs, and that we provide treatment and support for those who need it, both for mental illnesses and for substance use disorders.”

From the antibiotic resistance (“AR”) front, we learn that the CDC has updated its AR investment map.

“Highlights of this year’s AR Investment Map release include:

  • An interactive map showcasing CDC’s antibiotic resistance funding to support activities in every U.S. health department and across hundreds of public health partners
  • An updated fact sheet featuring CDC’s global investments with partners in more than 50 countries to improve detection, prevention, and response to AR threats internationally
  • An updated fact sheet showing how CDC’s COVID-19 efforts have also worked to address antibiotic resistance, including investments in infection prevention and control, training, surveillance, and public health personnel.”

Obviously, this is an important government initiative.

From the healthcare business front —

Anthem is betting on a different strategy than some of its competitors as it looks to transition to value-based care.

The payer is partnering with many value-based clinical platforms like Privia and CareMax to bring physicians into alternative payment models aiming to reimburse for the quality of care delivered, as opposed to pure volume. That’s a different tack on value-based primary care than its peers like UnitedHealth and Humana, which have mostly acquired and built their own clinical networks.

But Anthem is betting its capital-light strategy is more sustainable and flexible as the payer looks to push deeper into capitation to really bend the cost curve.

  • Health Payer Intelligence tells us that

Walmart has partnered with a healthcare machine intelligence company to offer a personalized provider recommendation tool to associates who receive healthcare coverage through the retail giant’s health plan.

The company, Health at Scale, will provide the technology that Walmart intends to integrate into its health plan administrator’s search engine and virtual care referrals, according to the press release.

Associates and their families who are enrolled in Walmart’s health plan and work at select locations will have access to the resource, which aims to facilitate the process of finding a healthcare provider that fits a member’s health needs.

From the Rx coverage front, the always thought provoking Drug Channels opines that

The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare. (See links below.) These data provide our first official look at how the pandemic has affected U.S. healthcare spending.

Today, I examine the key insights from these latest figures.

As you will see, outpatient drug spending remains a small—and shrinking—share of the $4.1 trillion spent on U.S. healthcare. What’s more, drug spending again grew more slowly than overall healthcare spending.

Meanwhile, consumers shoulder a much higher portion of this spending compared with their share of hospital spending.

Speaking of CMS that agency today released “the Calendar Year (CY) 2023 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2023 Advance Notice through Friday, March 4, 2022, before publishing the final Rate Announcement by April 4, 2022.” Here’s a link to the CMS fact sheet.

The FEHBlog wishes that OPM would release a draft call letter for carrier comment before finalizing it. In fairness OPM does solicit carrier input before it draft the call letter. Nevertheless, it would be more collaborative for OPM to seek carrier comment before drafting and then on the first draft.

From the HR front, Federal News Network reports that

A new memo from the Office of Personnel Management released today, offers them performance management tips for a hybrid workplace.

“Effective performance management requires engagement and commitment from individuals at all
levels of an agency,” the memo says. “As such, these performance management tips have been uniquely tailored to assist Non-supervisory Employees, Supervisors, and Leadership throughout the various phases of the performance management cycle.”

And now with agencies expected to begin returning employees to the office in the coming months, OPM wants to make sure managers are “equipped to manage employee performance equitably and effectively—regardless of whether the employees are in the office or not.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

The FEHBlog nearly fell off his office chair when he noticed a Govexec headline this afternoon reading “The House finally plans to vote on Postal reform [HR 3706] next week. The long sought after bill could make it to the President’s desk by the end of the month.” This Postal reform saga has been going on for over a decade.

The Postal reform act (HR 3706) would relieve the Postal Service of the obligation to prefund the cost of FEHB coverage in retirement for its employees. The bill also would create a Postal Service Health Benefits Program (“PSHBP”) within the FEHB Program. The PSHBP would tightly integrate Medicare annuitant coverage with primary Medicare A, B, and D. Medicare Part A (hospital care) is premium free while Medicare Part B (medical care) and Part D (prescription drugs) charge premiums.

OPM encourages Medicare age annuitants to pick up Part B but it prohibits FEHB carriers from using integrated Part D arrangements knowsn as EGWPs even though every other U.S. employer that provides drug coverage to its retirees uses a Part D EGWP or takes the retiree drug subsidy. What’s more Congress in the Medicare Modernization Act of 2003 expressly authorized FEHB plans to use Medicare EGWPs. Go figure.

In any event, all enrollee costs are included in FEHB risk pools which is an important feature of the FEHB Plan and its constituent PSHBP. The cost of Medicare Prime annuitants in the PSHBP will be much lower than those in legacy FEHB, and Medicare Prime annuitants are a signficant cadre of enrollment, PSHBP premiums will be noticeably lower than legacy FEHB premiums.

The CBO has projected that 3/5s of the Medicare integration savings for the PSHBP will come from the Part D EGWPs. The FEHBlog looks forward to the day later this decade when OPM finally permits legacy FEHB carriers to offer Medicare Part D EGWPs.

From the Covid vaccine front —

  • Pfizer and BioNTech have a submitted an emergency use authorization request for an mRNA Covid vaccine for little children aged six months through four years. The FDA and CDC are likely to approve the application by the end of February according to Medscape.

Novavax announced Monday that it has formally submitted a request to the FDA for emergency use authorization of its COVID-19 vaccine for ages 18 and older.

The request includes results from two large clinical trials that showed an overall efficacy of about 90% and a “reassuring safety profile,” the company said.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, the president and CEO of Novavax, said in the statement.

From the COVID treatment front, the Wall Street Journal reports that providers are having difficulty obtaining the drugs need to treat Omicron because the treatments typically are available under emergency use authorizations and each State makes its own decison on how to distribute EUA treatments. On the brighter side,

Antiviral-pill manufacturers are ramping up production to meet demand. Supplies of Pfizer Inc.’s Paxlovid are expected to increase in the spring, according to Pfizer and state officials. Merck & Co., which manufactures molnupiravir with partner Ridgeback Biotherapeutics LP, said it has delivered two million courses to the U.S. and will deliver the rest of the 3.1 million courses under its contract by the end of this week.

From the healthcare cost front, Healthcare Dive reports that

The omicron variant walloped hospitals in the final month of 2021, driving up both adjusted patient volumes and expenses as the number of COVID-19 cases surged to new highs for the pandemic, according to Kaufman Hall’s latest flash report.

Patient days rose nearly 4% in December compared to November, while emergency department visits jumped more than 7% as patients came in with COVID-19 symptoms. Omicron’s rapid spread drove a 98% jump in COVID-19 hospitalizations over the course of the month, Kaufman Hall said, citing Centers for Disease Control and Prevention data.

The second full year of the pandemic was marked by an increase in severely ill patients requiring longer hospital stays compared to the first year, the report also found.

From the No Surprises Act front, Healthcare Dive examines healthcare provider association legal challenges to the federal regulators’ use as the qualifying payment amount in NSA arbitrations. The FEHBlog has described those cases now pending in federal district courts in Texas and Washington DC as exercises in futility. For example,

Since the qualifying payment amount represents the median in-network rate, it by definition means that half of providers are below the QPA and half are above, according to Chris Garmon, a professor at University of Missouri – Kansas City, who has studied surprise billing. Not all providers are set to see payments decline and some may even see them increase if the QPA is used, he said.

The good professor overlooks the fact that in 2021 out of network doctors caring for patient at in-network facilities were reimbursed at out-of-network rates typically two or perhaps three times the Medicare RBRVS reimbursement. For that reason, the FEHBlog expects that in most cases the QPA will be noticeably higher than pre-NSA reimbursements. Time will tell, but the regulators’ approach is reasonable, and patient advocacy groups have been supporting the regulators in these cases.

From the mental health parity front, Health Payer Intelligence compares provider and payer reactions to the government’s recent report to Congress on payer compliance with complex federal health parity act rules.

From the healthcare business front, Fierce Healthcare tells us that

GuideWell, the parent company of Blue Cross and Blue Shield of Florida, has closed its acquisition of Triple-S Management Corporation, a Puerto Rico-based health services company.

The deal was first announced in September.

GuideWell acquired all shares of Triple-S at $36 per share in cash, according to an announcement from the company. Triple-S will now operate under its existing branding as a wholly owned subsidiary of GuideWell.

From the FDA front, check out this FDA news roundup.

From Capitol Hill, Govexec reports on OMB acting director’s Shalonda Young’s confirmation hearings to be the Presidentially nominated OMB director. Ms. Young appears on her way to confirmation.