Tuesday’s Tidbits

Mental health care

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on UnsplashFr

From the Omicron and siblings front, the Wall Street Journal reports

Omicron Covid-19 variants BA.4 and BA.5 are on the rise in the U.S., adding two more highly contagious versions of the virus to the mix that has fueled a springtime surge in cases.

The closely related subvariants represented a combined 13% of U.S. cases for the week ended June 4, according to estimates the Centers for Disease Control and Prevention released on Tuesday. Evidence suggests the variants are yet-more contagious versions of Omicron, public-health experts said, that may be able to evade some of the immune protections people built up from infections triggered by another version of Omicron during the winter.

The spread of the subvariants could at least prolong the time it takes to emerge from the current wave fueled by other versions of Omicron, some health experts said.

The Journal adds

This case wave hasn’t translated to a significant surge in severe illness. Hospitalizations, while up, remain far below earlier peaks, and reported Covid-19 deaths have recently hovered near historically low levels.  * * * Epidemiologists believe built-up immunity from vaccines and prior infections have bolstered defenses against severe illness, even though many people are falling ill from both breakthrough and repeat infections.

AHIP informs us

Today the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant emergency use authorization (EUA) for the Novavax COVID-19 vaccine in adults by a vote of 21-0.

The Committee reviewed data from Novavax showing that the benefits of the two-dose primary series outweigh the potential risks. The Committee noted the importance of making a vaccine available that has an alternative method of action, different from the mRNA vaccines currently available in the U.S., in the hope that a more traditional vaccine may appeal to those currently unvaccinated and those who may have an allergy to the components of the mRNA vaccines.

Committee members agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA is expected to make a decision on granting Novavax an EUA soon, whereby the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to determine when and how the vaccine should be administered.

BioPharma Dive tells us

Pfizer on Monday announced plans to invest $120 million in a drug manufacturing facility located in Kalamazoo, Michigan, which will lead to the creation of over 250 jobs.

The investment is aimed at accelerating production of Pfizer’s COVID-19 pill Paxlovid, demand for which has risen after Pfizer’s initial struggles to make sufficient quantities following the drug’s clearance in December. To date, Pfizer has delivered 12 million courses of the drug across 37 countries, 5 million of which have been shipped to the U.S.

The Kalamazoo plant, one of Pfizer’s largest drugmaking sites, will make the starting materials and active ingredient contained within Paxlovid. The new investment expands the site’s capacity, making it one of the world’s largest producers of pharmaceutical ingredients, according to Pfizer.

From the Rx coverage front, the Federal Trade Commission announced

The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. * * *

The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:

** fees and clawbacks charged to unaffiliated pharmacies;

** methods to steer patients towards pharmacy benefit manager-owned pharmacies;

** potentially unfair audits of independent pharmacies;

** complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

** the use of specialty drug lists and surrounding specialty drug policies;

** the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

The Commisioners voted 5-0 to commence the investigation. Responses from the PBMs to the FTC’s compulsory orders are due in 90 days.

From the Pride Month front, Health Payer Intelligence reports “Members of the LGBTQ+ community reported varying experiences of discrimination in the health insurance industry but indicated that payer health equity may be improving, according to a survey from Healthcare.com.” Survey details are available in the article and the survey.

From the miscellany department

  • The American Medical Association offers expert guidance on understanding blood pressure readings.
  • The Centers for Disease Control explains the connection between diabetes and the brain.

Anthem has partnered with Happify Health to offer a slate of new digital tools for women’s health.

Happify’s platform is based on “sequences,” or digital experiences that it uses to support specific medical conditions. These sequences combine evidence-based digital therapeutics, online communities, coaching and tailored local resources in one unified platform.

Happify’s sequences are able to integrate with existing systems and solutions for ease of navigation, according to the announcement.

Everyone deserves access to mental health support that is effective and affordable. With more Americans than ever seeking help for mental health concerns, AHIP conducted a nationwide survey to understand people’s experience accessing care, whether their treatment was covered by insurance, and if insured patients were satisfied with the results. The findings reveal that nearly all respondents who sought mental health care for themselves or someone within their household over the past 2 years received treatment, and 3 in 4 insured Americans (73%) found it easy to get the care they needed. More than two-thirds of respondents were able to find an appointment with a provider in less than a month. In addition, 9 in 10 reported being satisfied with the mental health support they received, including half who say they were very satisfied.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, SCOTUS, Telehealth, U.S. Healthcare–

Congress is back on Capitol Hill this week for floor voting and Committee business. Roll Call notes

Lawmakers return next week for a busy June, with Senate Republicans tested by politically wrought gun talks and President Joe Biden dealing with a spate of crises and headaches.

The Hill identifies the five “looming disputes” out of 33 pending disputes that the Supreme Court is expected to decide this month which typically is the last month of its October 2021 Term. Although not found among the Hill’s cases, here’s a Medicare secondary payer act case that has not been decided yet and could impact FEHBP.

Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641 [Arg: 03.1.2022 Trans./Aud.] 

Issue(s): (1) Whether a group health plan that provides uniform reimbursement of all dialysis treatments observe the prohibition provided by the Medicare Secondary Payer Act that group health plans may not “take into account” the fact that a plan participant with end stage renal disease is eligible for Medicare benefits; (2) whether a plan that provides the same dialysis benefits to all plan participants, and reimburses dialysis providers uniformly regardless of whether the patient has end stage renal disease, observe the prohibition under the Medicare Secondary Payer Act that a group health plan also may not “differentiate” between individuals with end stage renal disease and others “in the benefits it provides”; and (3) whether the Medicare Secondary Payer Act is a coordination-of-benefits measure designed to protect Medicare, not an antidiscrimination law designed to protect certain providers from alleged disparate impact of uniform treatment.

From the Omicron and siblings front —

The Wall Street Journal reports

The latest Covid-19 wave in the U.S. has shifted westward, hitting places like the San Francisco area, while pressure eases in recent Northeast hot spots.

The Western U.S. region, which includes mountain and coastal states, has recently eclipsed the Northeast to have the nation’s highest rate of known cases per 100,000 people, a Wall Street Journal analysis of CDC data shows. Recent increases in parts of the West come amid declines in the Northeast.

NPR Shots provides more background on the Novovax Covid vaccine that the FDA advisory committee will consider for emergency use authorization this Tuesday. NPR Shots adds

The federal government is trying to decide what kind of booster people should get in the fall to try to blunt the severity of a possible new wave of infections next winter. The panel of FDA advisers will meet late this month to consider which strains of the coronavirus should be targeted by updated vaccines.

From the mental health coverage front, the American Hospital Association released a TrendWatch about the pandemic’s adverse impact on mental health. Also, Healthcare Dive informs us that while telehealth use dropped in February and March 2022, according to a Fair Health study,

Teletherapy continued to remain robust, snagging the top procedure spot for telehealth visits in March and representing 26% of virtual claim lines, the report noted. Mental health conditions claimed 65% of diagnoses across all regions. Likewise, social workers remained the most popular specialty in telehealth claims for the second month in a row.

From the value-based care front, Health Payer Intelligence discusses how payers can move providers away from fee-for-service contracts to value-based contracts. It’s worth a read.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 22nd week of 2022:

The CDC’s weekly review of its Covid statistics explains “As of June 1, 2022, the current 7-day moving average of daily new cases (100,684) decreased 8.5% compared with the previous 7-day moving average (110,081).”

Here’s the CDC’s current chart of new Covid hospitalizations:

The CDC’s weekly statistical review notes that “The current 7-day daily average [of new Covid hospitalizations] for May 25–31, 2022, was 3,789. This is a 4.7% increase from the prior 7-day average (3,619) from May 18–24, 2022.

Here’s the FEHBlog’s weekly chart of new Covid deaths from the 27th week of 2021 through the 22nd week of 2022:

The CDC’s weekly statistical review adds “The current 7-day moving average of new deaths (244) has decreased 23.1% compared with the previous 7-day moving average (318).” 

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in December 2020 through the 22nd week of 2022.

According to the CDC’s weekly statistical review,

Overall, about 258.7 million people, about 221.4 million people, or 66.7% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 103.5 million people have received a booster dose,** but 49.0% of the total booster-eligible population has not yet received a booster dose. As of June 1, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 343,662, a 9.5% decrease from the previous week.

To wrap up the statistic review, the CDC’s weekly statistical review tells us

As of June 2, 2022, there are 240 (7.45%) counties, districts, or territories with a high COVID-19 Community Level, 733 (22.76%) counties with a medium Community Level, and 2,247 (69.78%) counties with a low Community Level. This represents a slight (−0.53 percentage points) decrease in the number of high-level counties, a small (+1.37 percentage points) increase in the number of medium-level counties, and a corresponding (−0.84 percentage points) decrease in the number of low-level counties. Fifty-one (98.1%) of 52 jurisdictions had high- or medium-level counties this week.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

In other Covid news

The Wall Street Journal reports

Novavax Inc.’s vaccine was 90% effective at preventing Covid-19 in its pivotal trial, but the performance came before the emergence of the Omicron variant that has eluded vaccines more than earlier strains, U.S. health regulators said.

The Food and Drug Administration also expressed concern Friday that six people developed heart-inflammation conditions known as myocarditis and pericarditis, out of about 40,000 people who had taken Novavax’s vaccine during various studies. 

The agency released its evaluation of Novavax’s Covid-19 vaccine ahead of a meeting of outside advisers who are scheduled to discuss next week whether the agency should recommend authorization of the shot.

The FDA staff’s appraisal suggests the vaccine could face a tough round of questioning from advisers weighing the shot’s uncertain efficacy against Omicron with potential heart risks.

This suggests an unfortunate outcome. The Novovax vaccine was developed using a traditional approach may be acceptable to the vaccine inquisitive.

In healthcare business news

  • Health Leaders Media informs us “Health insurers are not holding up their end of the bargain on mutually accepted prior authorization reforms, according to a new physician survey by the AMA.” The FEHBlog is growing concerned that the AMA is winning the prior authorization war.
  • Fierce Healthcare tells us “Optum has invested heavily in building out its provider enterprise. But executives at UnitedHealth Group say it’s still early days for the endeavor.”
  • Healthcare Dive reports “The Federal Trade Commission is suing to block two separate hospital mergers, the agency said Thursday. The FTC has sued to block HCA Healthcare’s acquisition of Steward Health Care System, alleging that the deal would reduce competition in Utah and ultimately raise prices. In another suit, the FTC is moving to block RWJBarnabas Health from acquiring Saint Peter’s Healthcare in New Jersey, alleging ‘overwhelming evidence’ that the deal would harm patients in the form of less choice and higher prices.”
  • The Healthcare Dive article adds

The FTC has now challenged numerous hospital deals this year following its latest action.

Rhode Island’s two largest health systems abandoned plans to merge in February about a week after the FTC sued to block the deal.

New Jersey’s largest health system, Hackensack Meridian Health, lost its appeal challenging the FTC’s move to prevent a tie-up with Englewood Hospital, one of the last independent hospitals in the area.

Bristol Myers Squibb is buying biotech Turning Point Therapeutics, announcing Friday a $4.1 billion deal that will give the pharmaceutical company an experimental drug that targets mutations found in lung cancer and other solid tumors.

The deal values Turning Point at $76 a share, more than double the $34.16 at which shares closed on Thursday and four times the biotech’s $18 initial public offering price in 2019. Yet the buyout price is well below the company’s peak of $133 a share in February 2021, which gave it a market value of $6.6 billion.

The company’s lead drug, called repotrectinib, has advanced through Phase 2 testing in lung cancer patients whose tumors harbor a mutation called ROS1. Repotrectinib would compete against Roche’s Rozlytrek, if approved. Bristol Myers expects to gain Food and Drug Administration clearance in the second half of 2023.

That’s a lot of money.

From the studies department

Fierce Healthcare points out

As the industry puts a focus on mental health coming out of COVID-19, a new study suggests that loneliness may be a key place to start.

Research from Cigna and Morning Consult finds that more than half (58%) of U.S. adults would be considered lonely. This is on par with pre-pandemic research, which found that 61% of adults are lonely, and made for a seven percentage point increase from 2018.

Loneliness and mental health issues are closely linked, according to the study. Adults with mental health concerns were twice as likely to feel lonely compared to those with strong mental health. The study also found that minorities and younger people were also more likely to be dealing with loneliness.

Three-quarters (75%) of Hispanic adults and 68% of Black adults are classified as lonely, according to the study, figures both substantially higher than the rate of loneliness in the general population. Seventy-nine percent of adults aged 18 to 24 said they feel lonely, compared to 41% of seniors aged 66 and over.

The FEHBlog wishes his readers a weekend full of family and friendship.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, STAT News reports

The sweeping FDA funding bill unveiled by senators Friday would direct the FDA to stand up an “intra-agency coordinating council” to oversee its use of the controversial accelerated approval pathway, my colleague Lev Facher writes. The policy seems a clear response to the controversy over the FDA’s approval of Aduhelm — and it’s the latest sign that lawmakers are within striking distance of reforming the controversial pathway, which allows the FDA to greenlight drugs without clear evidence they extend patients’ lives. 

Accelerated approval not your bailiwick? There’s plenty more in the 433-page bill too, including a proposal from Sen. Elizabeth Warren that would force the FDA to finally release regulations meant to lower the cost of hearing aids. Conspicuously missing from the legislation? Any of the House’s proposals on clinical trial diversity. 

For more on the package, check out Lev’s story here. 

From the Omicron and siblings front

AP tells us

The coronavirus mutant [BA 2.12.1] that is now dominant in the United States is a member of the omicron family but scientists say it spreads faster than its omicron predecessors, is adept at escaping immunity and might possibly cause more serious disease.

Why? Because it combines properties of both omicron and delta, the nation’s dominant variant in the middle of last year. 

A genetic trait that harkens back to the pandemic’s past, known as a “delta mutation,” appears to allow the virus “to escape pre-existing immunity from vaccination and prior infection, especially if you were infected in the omicron wave,” said Dr. Wesley Long, a pathologist at Houston Methodist in Texas. That’s because the original omicron strain that swept the world didn’t have the mutation.

Tricky little devil.

The Wall Street Journal adds that

Most people with Covid-19 will still test positive on a rapid test at five days, and a “fairly large percentage” test positive after 10 days, CDC spokeswoman Jasmine Reed said. Infectiousness drops significantly at eight days, with few people remaining contagious at 10 days, she said. 

The CDC guidance also takes symptoms into account as a factor to gauge contagiousness, she said, noting that people should only leave isolation after five days if their symptoms are improving. The CDC recommends that everyone wear a well-fitted mask and avoid travel and being around high-risk people for 10 days, no matter when the person leaves isolation. * * *

At the beginning of an infection, when a person’s viral load is rising, it might take a few days before tests turn positive. That is why health authorities recommend that people with symptoms and negative rapid-test results wait and retest or get a more sensitive lab-based PCR test.

As a person’s viral load drops, rapid tests are a better indicator of who is no longer infectious, public-health experts said. * * *

Immunocompromised people and those who get severely ill can be contagious even longer than 10 days, studies suggest, and patients who experience rebounding symptoms or who test positive again after taking Pfizer Inc.’s Paxlovid pill should also assume that they are contagious, infectious-disease experts said.

David Leonhardt writes about the benefits of one-way masking in his New York Times column today. “Because masks work and mandates often don’t, people can make their own decisions. Anybody who wants to wear a snug, high-quality mask can do so and will be less likely to contract Covid.” That makes sense to the FEHBlog.

In healthcare business new, the American Hospital Association informs us

According to a report by Kaufman Hall, hospitals faced decreases in both patient volume and revenue in April. Year-to-date hospitals have struggled to rebound from winter surges and new spikes in COVID-19. Median operating margins declined for the fourth straight month with patient volume down 6.5%, revenue down 7%, and expenses continued to climb well above pre-pandemic levels and 9.6% year-to-date higher than 2021.

Healthcare Dive reports

* In its latest earnings report, Change Healthcare highlighted its momentum heading into the next fiscal year, outlining what 2023 could look like for the data analytics company as a standalone business in the event its controversial $13 billion merger with UnitedHealth falls through.

* In previous quarters, Change has not provided formal forward-looking guidance given the pending transaction. But in fourth-quarter results released last week, Change said it expects between 2% to 4% growth in its core Solutions business in 2023, moderately below analysts’ consensus, and roughly flat earnings before interest, taxes, depreciation and amortization margins.

* Change noted the flat margins are due to some wage pressure, lower volume-driven revenues as COVID-19 cases drop and client attrition due to its proposed merger with UnitedHealth’s health services arm, Optum. 

The trial over the Justice Department’s challenge to this merger begins in August.

In public health news Medscape explains

Each day between 2017 and 2019, nearly 2,300 adolescents and young adults became new daily tobacco users — a figure that mirrors statistics from 1989 to 1993.

According to a longitudinal study, the total number of daily vape (or e-cigarette) users under 21 years of age rose to more than 1 million by 2019. Of those, 56.3% used Juul products in particular, reported cancer prevention researcher John Pierce, PhD, of the University of California San Diego in La Jolla, and colleagues in Pediatrics.

“The large increase in daily use among U.S. adolescents could presage future health consequences and needs urgent additional action from the [FDA],” the authors wrote.

From the mental health coverage front, the Society for Human Resources Management discusses how employers are grappling with a surge in employee mental health issues.

Also the Biden Administration marks the end of mental health awareness month by listing its accomplishments and plans, including

In addition to facilitating access to comprehensive telebehavioral health benefits through the Federal Employees Health Benefits Program, the Office of Personnel Management (OPM) is working to reinvigorate Employee Assistance Programs provided by all federal agencies to better meet employees’ behavioral health needs, while disseminating best practices and new ideas for improving federal workplace mental health.

From the medical research front, STAT News reports

Bay Area biotech Ultima Genomics on Tuesday claimed that its technology can sequence a whole human genome for $100, making it a surprise player in the race to read DNA quickly, accurately, and cheaply.

The company didn’t provide specifics or immediately reply to an inquiry from STAT as to how it calculated that cost. But a $100 genome would represent a major drop in price, one that could help researchers unlock sequencing’s potential to unravel the mysteries of undiagnosed diseases, spot early signs of cancer, and better understand human health. That’s because while the cost of reading a full human genome has plummeted from around $95 million in 2001 to about $560 in 2021, according to the National Human Genome Research Institute, sequencing is still too pricey to be routinely used in health care and research.

That’s an intriguing development.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

Lawmakers are facing increased pressure to pass a comprehensive mental health and substance use package but are unlikely to make an initial goal of advancing legislation before the implementation of a three-digit suicide hotline in July.

At least four congressional committees have committed to advancing a swath of bipartisan mental health bills under their jurisdiction, but lawmakers have not yet unlocked the puzzle of how to incorporate a growing laundry list of programs to authorize and establish existing and new programs dedicated to treatment, prevention, education, crisis care, drug interdiction and the workforce.

One of those four committees is the Senate Finance Committee which announced today

Senate Finance Committee Chair Ron Wyden (D-Ore.), Ranking Member Mike Crapo (R-Idaho), Senator Ben Cardin (D-Md.) and Senator John Thune (R-S.D.) today released a discussion draft for telehealth policies as a part of the committee’s ongoing work to improve mental health care across the nation, which has included a public call for comments and three hearings to help develop these initiatives. * * *

The discussion draft includes policies that would:

* Remove Medicare’s in-person visit requirement for tele-mental health services.

* Establish benefit transparency for mental health care services delivered via telehealth to inform Americans with Medicare how and when they can access telehealth.

* Preserve access to audio-only mental health coverage in Medicare when necessary and appropriate.

* Direct Medicare and Medicaid to promote and support provider use of telehealth.

* Incentivize states to use their CHIP programs to establish local solutions to serve behavioral health needs in schools, including through telehealth.

From the Omicron and siblings front

Beckers Hospital Review informs us

A highly contagious sublineage of the BA.2 omicron subvariant is now the nation’s dominant strain, according to the CDC’s latest variant proportion estimates. 

The sublineage, BA.2.12.1, accounted for 57.9 percent of all U.S. COVID-19 cases in the week ending May 21, CDC data shows. BA.2, which became the nation’s dominant strain in mid-March, now accounts for an estimated 39.1 percent of all cases.

BA.2.12.1 is estimated to have a 25 percent growth advantage over BA.2, which is already more transmissible than the original omicron strain. The newer omicron sublineage has been gaining traction in the U.S. over the last month. In the week ending April 23, BA.2.12.1 accounted for just 24.1 percent of U.S. COVID-19 cases. 

Health officials are also monitoring another omicron subvariant — BA.1.1.529 — which currently accounts for an estimated 2.8 percent of cases.  

“Epidemiologically, it doesn’t appear as if we’re seeing more severe disease in places that are having more cases,” CDC Director Rochelle Walensky said of the sublineages during an April 26 news conference. “So we are not anticipating more severe disease from some of these subvariants, but we are actively studying it.”

CBS News reports

As many as one in four seniors and one in five adults under 65 experienced “long COVID” or “post-COVID” symptoms after surviving a coronavirus infection, a new study from the Centers for Disease Control and Prevention reported Tuesday. 

The study — published in the CDC’s Morbidity and Mortality Weekly Report — is the latest to try and quantify how many of the millions of Americans who have now tested positive for the virus are facing long-term issues caused by their infection. 

By comparing electronic health records in a large national database of patients, the study’s authors found 38.2% of COVID-19 survivors “experienced at least one incident condition” — a list that includes heart, lung, kidney and gastrointestinal problems, pain, fatigue, loss of smell or taste, mental health issues, and more —  in the months after their infection. By contrast, just 16% of other people were diagnosed with such conditions.

The Wall Street Journal adds

Vaccination reduces your risk of developing long Covid, but not by much on average, new research suggests. 

A Veterans Affairs study out Wednesday found that vaccinated people with breakthrough Covid-19 infections had a 15% reduction in experiencing persistent or new symptoms and health conditions up to six months after infection compared with those who were unvaccinated and got Covid. 

Most of the vaccinated people had received two doses of the Pfizer or Moderna vaccine, while 8% received one dose of the Johnson & Johnson vaccine. The study didn’t look at people who had received boosters.

Bloomberg discusses the risks of contracting Covid while pregnant.

Canada’s first dual specialist in infectious diseases and obstetrics/gynecology, Deborah Money, MD comments “For the most part, women in communities even with Covid circulating do well,” she says. “The majority of babies are fine.”

But that’s just part of the story. Their analysis of data from 6,012 people in six Canadian provinces who tested positive for the virus during their pregnancy found a substantial increase in hospitalizations and ICU admissions compared with reproductive-age, non-pregnant females infected with the coronavirus. Their study in the May 2 issue of the JAMA medical journal also found that 11.1% of Covid–affected pregnancies resulted in preterm birth, compared with 6.8% among all unaffected Canadian pregnancies. * * *

Money says it underscores the need for obstetricians to carefully monitor their pregnant patients who become infected with SARS-CoV-2, and for expecting moms to get vaccinated and boosted.

“That’s the biggest thing they can do,” she says. “It really does look like vaccine is preventative for the serious outcomes.” 

From the studies front —

  • The Medical Group Management Association informs us “Despite multiple waves of disruption in 2021, medical practices navigated through the “new normal” of COVID-19 to restore a sense of normalcy in productivity and compensation last year.”
  • Milliman released its 2022 Medical Index (MMI). “In 2022, the cost of healthcare for a hypothetical American family of four covered by an average employer sponsored PPO plan is $30,260,” 4.6% above 2021.
  • HR Dive tells us “[a] 2019 IRS notice expanded the list of medications and health services Health Savings Account-eligible health plans may cover prior to meeting a patient’s deductible. Employers that take advantage of the expansion could cover these treatments with little to no increases in patient premiums, according to an Employee Benefits Research Institute report published May 19.”

Commercial insurance members’ satisfaction with their plans stayed flat between 2021 and 2022, according to a new survey from J.D. Power.

Satisfaction was on a steady climb over the past five years, the survey found, but plateaued in the past year amid declines in how well members’ expectations for customer service were met and dissatisfaction with their plan designs and network providers.

Health plans that were perceived by members as responsive enjoyed higher scores than those that were not, J.D. Power found. The Kaiser Foundation Health Plan and regional Blues insurers were consistently ranked as the highest scoring in the study’s 22 geographic regions.

From the mental healthcare front, the International Foundation of Employee Benefit Plans notes

The U.S. Department of Labor (DOL) published new guidance on obtaining job protected leave under the Family and Medical Leave Act (FMLA) for workers seeking mental health support. The guidance clarifies that eligible employees are able to take FMLA leave for their own serious health condition or to care for a spouse, child or parent because of their serious health condition, and that a serious health condition can include a mental health condition.

The guidance includes:

* Fact Sheet #28O: Mental Health Conditions and the FMLA, and

* Frequently Asked Questions on the FMLA’s mental health provision

From the federal employee benefits front, benefits consultant Tammy Flanagan writes in Govexec about Federal Employee Group Life Insurance Program options for federal and postal annuitants. What’s more, Fedweek explains how FEHBP fills Medicare coverage gaps for those fine folks.

Weekend Update / Monday Roundup

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Mental health care, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

The Senate will and the House of Representatives will be engaged only in Committee business this coming week.

From the Omnicron and siblings front —

  • Fortune reports “The U.S. is experiencing a sixth wave of COVID, with over 90,000 confirmed new cases a day and a 20% increase in hospitalizations over the past two weeks. The actual number of new cases per day likely sits at a half-million or more, “far greater than any of the U.S. prior waves, except Omicron,” writes Dr. Eric Topol, the executive vice president of Scripps Research and a professor of molecular medicine, in a recent blog post on the maps.” It’s hard to argue against this point.
  • Bloomberg Prognosis offers a useful Q&A on when you can back to life after a case of Omicron. Here is a link to the CDC’s guidelines on isolation and quarantine due to Omicron.
  • The FEHBlog noticed that 75% of the American population age 12 and older is fully vaccinated against Covid.
  • The American Medical Association discusses how Covid telemonitoring sets the model for other acute conditions.

From the Aduhelm front, the Wall Street Journal reports

The commercial failure of Biogen Inc.’s drug Aduhelm is putting new focus on the state of research into the causes of Alzheimer’s disease.

More than six million people in the U.S. are living with the progressive type of dementia, according to the Alzheimer’s Association, an advocacy group. 

Aduhelm was hailed as a potential blockbuster that targeted a root cause of the disease by clearing a sticky protein known as amyloid from the brain. Abnormal accumulations of amyloid called plaque and tangles of another protein known as tau are characteristic features of the brains of people with Alzheimer’s.

“If you cut the brain open and amyloid plaque is absent, Alzheimer’s was not the cause of disease,” said Jeffrey Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas.

But research into the benefits of targeting amyloid in Alzheimer’s patients has been mixed. There are more questions than answers about the role amyloid plays in the development of the disease, neurologists say. 

“Alzheimer’s is a complex disease. It’s unlikely that a single mechanism is contributing to it,” said Maria Carillo, the Alzheimer’s Association’s chief science officer. * * *

More than 140 drugs are in the pipeline as potential Alzheimer’s treatments, including drugs that target tau and microglia function, according to a survey of registered clinical trials in the U.S. Three other amyloid-targeting monoclonal antibodies, which are in the same class as Aduhelm, are in development. One, called lecanemab, was submitted this month by co-developers Biogen and Japan-based Eisai Co. to the Food and Drug Administration for potential approval.

Time will tell.

From the preventive care wellness front —

  • Medscape reports an “alarming increase in esophageal cancers in middle-aged adults. The study’s author,  Bashar Qumseya, MD, MPH, recommends that people with multiple risk factors for these cancers, i.e., obesity, diet, and gastroesophageal reflux disease, should undergo an endoscopy at the time of their first colonoscopy at age 45.
  • The American Medical Association identifies steps that patients can follow to reverse pre-diabetes.

The FEHBlog just discovered that the Weekend Update did not go out on Monday morning. So here are Monday’s items that normally would have been posted in the Monday Roundup —

More from the Omicron and siblings front —

BioPharma Dive reports

Three doses of Pfizer and BioNTech’s COVID-19 vaccine met the Food and Drug Administration’s bar for success in a trial studying the shot in children younger than 5 years old, the companies said Monday. The FDA has tentatively scheduled a meeting of outside advisers to review the data in three weeks.

The agency delayed review of the vaccine in the youngest children earlier this year after a December review of data indicated a two-shot series didn’t spur an immune response that was likely to protect against disease. When Pfizer and BioNTech disclosed that data, they announced plans to test immune response and efficacy after three shots.

The announcement comes days after U.S. officials warned of a new surge of COVID-19 cases as mask mandates have been lifted and while immunity from vaccination and previous infections wanes. The FDA has granted emergency use authorization for as many as four shots of Pfizer and BioNTech’s vaccine — an initial two-dose series followed by two periodic boosters — for adults at least 50 years old.

Reuters adds U.S. “Health officials are considering extending the eligibility for a second COVID-19 vaccine booster dose to people under 50 amid a steady rise in cases, with the United States seeing a threefold increase over the past month.”

Bloomberg Prognosis recommends carrying around a portable carbon dioxide monitor to help prevent Covid or at least remind you to mask up and / or move along:

Carbon-dioxide monitors can assess how Covid-risky a space is because they help tell you whether you’re breathing in clean air. They measure the concentration of carbon dioxide, which people exhale when they breathe, along with other things like, potentially, virus particles. The more well-ventilated a space, the lower the reading on my monitor’s screen — meaning not only less carbon dioxide but also less of the stuff like Covid that might make people sick. 

One place I didn’t expect this to be an issue was airplanes, because you hear so much about their top-of-the-line air quality systems. But in fact, some of the highest carbon dioxide readings on my travels were taken on flights, specifically during the boarding process.

It turns out that during boarding and deplaning, air systems aren’t typically running. Those periods are risky because people are mingling more than they do during a flight, says Joe Allen, an associate professor at the Harvard T.H. Chan School of Public Health who carries around his own CO2 monitor.

“We’ve been warning about this,” Allen says. 

Fresh air is important for our health in ways that go well beyond Covid, but it’s also largely invisible. Carbon-dioxide monitors can change that. 

What will they think of next?

The FEHBlog confesses that he took his eye off the flu virus this year. Beckers Hospital Review informs us “The CDC estimates there have been at least 6.7 million flu illnesses, 69,000 hospitalizations and 4,200 flu-related deaths so far this season.”

In other virus news, Reuters reports “Infection with adenovirus, a common childhood virus, is the leading hypothesis for recent cases of severe hepatitis of unknown origin in children that have led to at least six deaths, U.S. health officials said on Friday [May 20]. Furthermore,

The Centers for Disease Control and Prevention (CDC) said it is continuing to investigate whether 180 cases identified in 36 states and territories since last October represent an increase in the rate of pediatric hepatitis or whether an existing pattern has been revealed though improved detection.

From the mental healthcare front, Fierce Healthcare tells us

Mental health concerns are on the rise among teens, and the impact on parents and families is an unmet need employers could address, new data from Cigna’s Evernorth show.

The pandemic has significantly worsened mental health among teens and young adults, with 25% experiencing depressive symptoms and 20% experiencing anxiety symptoms, a JAMA study shows. About 80% of the 1,000 parents included in Cigna’s survey said their children are struggling with their mental health.

Nearly one-fifth (18%) of parents say their child’s needs are negatively impacting their job performance and productivity, according to the survey. In addition, 55% said they do not have enough support from their employer, and 1 in 7 said they were forced to leave or stay out of the workforce to manage their teenager’s needs.

“I think there’s going to be a long tail for these kids and also their family members,” Stuart Lustig, M.D., national medical executive for behavioral health at Evernorth, told Fierce Healthcare. “I think we’re in this for the long haul.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medicare, Mental health care, OPM–

From Capitol Hill, The Hill informs us

Photo by Josh Mills on Unsplash

A growing number of Senate Democrats say they’re ready to take a tough vote on an amendment to keep the Title 42 health order in place at the U.S.-Mexico border if that’s what’s needed to move a stalled COVID-19 relief package. 

Senate Majority Leader Charles Schumer (D-N.Y.) has held the bill from the floor because Republicans are insisting on voting on a bipartisan amendment to overrule the Biden administration’s decision to lift Title 42, a pandemic order that has stopped thousands of immigrants from entering the country on asylum claims.   * * *

Without giving in to the Republicans’ demand for a vote on the hot-button issue of securing the border, COVID-19 relief could be stalled until after the November election.  

The amendment is expected to fail but it’s a tough vote for vulnerable Senate Democrats. 

More likely, in the FEHBlog’s view, the Majority Leader is waiting until the Title 42 health order is lifted later this month to see what happens.

From the Omicron and siblings front —

The Wall Street Journal informs us

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized Covid-19 booster shot from Pfizer Inc. and BioNTech SE.

Following the recommendation Thursday, many of the nation’s doctors, pharmacies and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children in the age group.

The shots are to be given five months after the second dose. The extra dose is one-third the amount that those 12 years old and above receive.

Also Thursday, the CDC said it was strengthening its recommendation that people 12 years and older who are immunocompromised, or who are 50 and older, should receive a second booster dose at least four months after their first.

This means that health plans must start covering the booster with no member cost-sharing pursuant to ACA FAQ 50.

The Journal adds

Moderna Inc.’s leader said it is possible the company would be able to start shipping its Covid-19 vaccine for use in young children as soon as early June, pending a decision by U.S. regulators.

“We are ready from a manufacturing standpoint,” Moderna Chief Executive Stéphane Bancel said during a virtual appearance Thursday at The Wall Street Journal’s Future of Everything Festival.

The FDA/CDC decision is expected next month.

In other virus news, STAT News interviewed a top CDC expert on monkeypox. From the FEHBlog’s standpoint, the key takeaway is that monkeypox is not Covid.

I think we can take away a lot from what we know about monkeypox in Congo Basin and in West Africa. Even if human-to-human transmission is documented, it is generally documented among very close contacts. So family members, people taking care of ill patients. Or health care providers.

In funding news, the Department of Health and Human Services announced today a $1.5 billion funding opportunity under the State Opioid Response

SOR grant program provides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.

From the miscellany department

  • Today “the U.S. Office of Personnel Management (OPM) released guidance regarding the implementation of EO 13932; Modernizing and Reforming the Assessment and Hiring of Federal Job Candidates.  OPM’s guidance represents a major step towards the federal government’s adoption of skills-based hiring practices and is an important innovation in federal hiring, which has historically relied on education and candidate self-assessments as a proxy for a candidate’s ability to perform in a job. This new approach helps hiring managers recognize and value skills regardless of where they were acquired, whether in a formal degree program, on the job, or on one’s own.”
  • Employee Benefit News identifies the ten most popular mental health and wellness apps.
  • Benefits consultant Tammy Flanagan discusses federal employee life insurance benefits in Govexec.
  • Health Payer Intelligence reports that CMS has updated the Medicare.gov website “to include new features such as highlighting pages that answer popular questions and spotlighting key steps that consumers should take related to Medicare coverage.”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Medicare, Mental health care, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The Secretary of Health and Human Services has extended the Covid public health emergency for another 90 days. Bloomberg explains, “The declaration allows the US to grant emergency authorizations of drugs, vaccines and other medical countermeasures, as well as administer those products to millions of people at no out-of-pocket cost. It’s also enabled millions of Americans to get health coverage through Medicaid, among other benefits.” Bloomberg’s sources expect the declaration to be renewed again in July 2022.

The American Hospital Association informs us

The Food and Drug Administration today authorized a single Pfizer COVID-19 booster dose for children aged 5-11 who completed the Pfizer vaccine primary series at least five months before. FDA authorized the vaccine for this age group last October.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research.

In public health news —

  • The federal government’s Million Hearts campaign has launched a website discussing hypertensive disorders of pregnancy. The site explains “Hypertensive disorders of pregnancy are a leading cause of maternal mortality and can put both mother and baby at risk for problems during pregnancy.1 High blood pressure can also cause problems during and after delivery. Importantly, hypertensive disorders of pregnancy are often preventable and treatable.”
  • The Centers for Disease Control has updated its website discussing diabetes and heart disease. The FEHBlog knows from his PCP about the dangerous relationship between those two diseases.

In survey news —

  • Beckers Hospital Review relates that “The Lown Institute, a nonpartisan healthcare think tank, released its ranking May 17 of the best hospitals in the U.S. for avoiding overuse of low-value tests and procedures.”
  • Fierce Healthcare tells us, “Utah is the healthiest state for seniors this year, earning high marks for low prevalence of smoking and excessive drinking, according to a new report from the United Health Foundation. The philanthropic arm of UnitedHealth Group issued its annual America’s Health Rankings senior report Tuesday morning, which highlights state-specific performance across a slew of measures as well as progress, or lack thereof, on several key health issues facing seniors.”

From the healthcare business front

Fierce Healthcare reports

Private insurance plans paid hospitals on average 224% more compared with Medicare rates for both inpatient and outpatient services in 2020, a new study found. 

Researchers at RAND Corporation looked at data from 4,000 hospitals in 49 states from 2018 to 2020. While the 224% increase in rates is high, it is a slight reduction from the 247% reported in 2018 in the last study RAND performed. 

“This reduction is a result of a substantial increase in the volume of claims in the analysis from states with prices below the previous average price,” the study said. 

The report showed that plans in certain states wound up paying hospitals more than others. It found that Florida, West Virginia and South Carolina had prices that were at or even higher than 310% of Medicare. 

But other states like Hawaii, Arkansas and Washington paid less than 175% of Medicare rates. 

The American Hospital Association replies

The RAND Corporation’s latest hospital pricing report again “overreaches and jumps to unfounded conclusions based on incomplete data,” AHA President and CEO Rick Pollacksaid today. “The report looks at claims for just 2.2% of overall hospital spending, which, no matter how you slice it, represents a small share of what actually happens in hospitals and health systems in the real world. RAND also continues to ignore that hospitals are not all the same. Researchers should expect variation in the cost of delivering services across the wide range of U.S. hospitals — from rural critical access hospitals to large academic medical centers. Tellingly, when RAND added more claims as compared to previous versions of this report, the average price for hospital services declined. This suggests what we have long suspected: you simply cannot draw credible conclusions from such a limited and biased set of claims. 

“Further, the results highlight what even the Medicare Payment Advisory Commission (MedPAC) acknowledges: Medicare does not fully cover the cost of providing care to Medicare beneficiaries. Pinning commercial prices to inadequate Medicare rates would cause even more financial strain to hospitals already facing tremendous challenges as a result of the ongoing COVID-19 pandemic and rising inflation. The result could be reduced patient access to care.” 

I agree with the American Hospital Association that the problem is Medicare. Why Sen. Sanders continues to push Medicare for All is a mystery to the FEHBlog.

Also, Healthcare Dive informs us

Humana plans to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 through its second joint venture with private-equity firm Welsh, Carson, Anderson & Stowe, according to a Monday release from the payer.

The clinics will be managed and operated under Humana’s CenterWell Senior Primary Care brand, and WCAS will have majority ownership while Humana will have a minority stake.

The $1.2 billion expansion builds upon an existing venture with the same firm to open 67 clinics by early 2023.

From the Rx coverage front, Drug Channel reports on “The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22.”

I had the honor of presenting during the event’s general session: The Specialty Pharmacy Industry Update & Outlook. As in past years, I was joined by Doug Long from IQVIA. 

You can download our full slide deck here: https://drugch.nl/asembia22. 

From the mental healthcare front, Health Payer Intelligence discusses another angle considered in the UHG report on seniors mentioned above.

Over the last decade, seniors have experienced rising rates of mental healthcare needs, drug-related deaths, and early mortality, the UnitedHealth Foundation’s 2022 Senior Report shows.

“The 2022 Senior Report shows that the wellbeing of older adults was declining before the pandemic, which we know exacerbated many of these challenges,” Rhonda Randall, DO, executive vice president and chief medical officer of UnitedHealthcare Employer and Individual, said in the press release. 

“We urge people to help the seniors in your lives reconnect with the communities and activities they have enjoyed in the past but may not yet have returned to. We are focused on reducing disparities in the health care system for everyone, including older Americans.”

In webinar news — The Labor Department is holding a virtual event on May 25 concerning building mental health-friendly workplaces.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Electronic health records, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The Hill reports

White House COVID-19 coordinator Dr. Ashish Jha issued a dire warning Thursday that the U.S. will be increasingly vulnerable to the coronavirus this fall and winter if Congress doesn’t swiftly approve new funding for more vaccines and treatments.

In an Associated Press interview, Jha said Americans’ immune protection from the virus is waning, the virus is adapting to be more contagious and booster doses for most people will be necessary — with the potential for enhanced protection from a new generation of shots.

STAT News offers this ray of sunshine

Epidemiologist David Dowdy of Johns Hopkins’ Bloomberg School of Public Health said that, despite the case increases, hospitalization and death rates overall remain relatively low compared with earlier periods in the pandemic — a reflection of how much immunity there is in the population.

“In some ways, this is encouraging, in that we’re starting to see a divergence between the number of cases and the number of hospitalizations and deaths,” Dowdy said. “But it’s also a little bit discouraging that we’ve been through all this and we’re still seeing a flat line and an uptick in the number of people getting admitted to the hospital and in people dying.”

In the FEHBlog’s view, the coordinator should stop fighting the Delta pandemic by focusing attention on better government distribution of Pfizer’s Paxlovid, which can cure the Omicron if taken timely. Kaiser Health News discusses this continuing and vexing distribution problem.

Unquestionably a need to focus attention on vaccinations and boosters remains essential. Govexec and Kaiser Health News ask why one-third of Americans over 65 have not received the first booster. Nearly all Americans over 65 are fully vaccinated. The article explains

People 65 and older account for about 75% of U.S. covid deaths. And some risk persists, even for seniors who have completed an initial two-dose series of the Moderna or Pfizer vaccine or gotten one dose of the Johnson & Johnson vaccine. Among older people who died of covid in January, 31% had completed a first vaccination round but had not been boosted, according to a KFF analysis of CDC data

FEHB plans are well-positioned to help with this effort, given their demographics.

In other virus news, the American Hospital Association tells us

The Centers for Disease Control and Prevention yesterday updated its testing guidance for clinicians treating children with hepatitis of unknown cause. The agency is investigating 109 potential hepatitis cases of unknown cause in U.S. children since last October, including five deaths. More than 90% of the patients were hospitalized, 14% received liver transplants and more than half had a confirmed adenovirus infection, but officials still don’t know the actual cause of their hepatitis and cautioned that it may take time to assess the evidence and learn more. Potential cases also have been reported in the United Kingdom and other countries. 

Following up on last night’s hospital system merger news, Healthcare Dive reports

The Advocate Aurora Health and Atrium Health merger is likely to get a close review from the Federal Trade Commission as the Biden administration has taken a tougher stance on healthcare consolidation, antitrust and legal experts say. * * *

“I don’t think anything of this size in a healthcare transaction today is going to get rubber stamped,” said Bill Horton, a partner at Jones Walker who focuses on healthcare transactions. * * *

“Historically, the FTC concern in hospital and healthcare institution mergers has been the geographic overlap,” Horton said.

Advocate Aurora and Atrium do not have any geographic market overlap. The systems span six separate states through the Midwest and South.

“It doesn’t raise the same red flags, but it doesn’t mean that it gets waved through,” said Leemore Dafny, a Harvard Business School professor and former deputy director of healthcare and antitrust at the FTC.

The FTC is likely to examine whether the two systems negotiate with the same insurers even if they’re in different geographic locations, Dafny said.

From the interoperability front, Health Data Management offers an interesting take on government efforts to meet lofty public health goals for Data Modernization Initiative.

From the mental health care front, and to end on a high note, Health Payer Intelligence informs us

Consumers reported having positive experiences with their employer-sponsored mental and behavioral healthcare coverage during the coronavirus pandemic, a survey conducted on behalf of AHIP discovered.

“Health insurance providers are working every day to support Americans by helping them find the mental health support and counseling they need at a price they can afford,” Matt Eyles, president and chief executive officer of AHIP, said in a press release.

Midweek update

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, NCQA, OPM, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From the Omicron and siblings front

The American Hospital Association informs us

COVID-19 vaccinations prevented an estimated 107,000 Medicare hospitalizations between January and May 2021, resulting in $2.6 billion in savings for Medicare and Medicare Advantage plans, according to a new report by the Department of Health and Human Services. The report estimates the impact of COVID-19 vaccination during a five-month period shortly after the first vaccine was authorized and recommended for health care workers and elderly people in long-term care facilities. Future analyses will examine hospitalizations prevented by vaccination during the delta and omicron waves, HHS said.

Bloomberg Prognosis tells us

Pfizer Inc. executives said patients who suffer a relapse in Covid-19 symptoms after taking a full course of Paxlovid should take more of the treatment, though current U.S. guidelines limit use to five consecutive days.

“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.

In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.”

As noted in the article, the fly in the ointment is that the FDA emergency use authorization does not expressly approve a second course of the medication.

From the Rx coverage front

MedCity News reports on Bristol Myers Squibb’s (BMS) NEX-T program to improve CAR-T treatments.

The company has described NEX-T as changes to manufacturing driven by the translational insights it has gleaned from treating thousands of patients with its CAR T therapies. In addition to a faster turnaround time, the strategy is intended to reduce the costs of the overall process.

One of the key goals for the next-generation of cell therapies is treating solid tumors.

Another strategy that BMS is pursuing is going after two targets with a single therapy, reducing the risk that a tumor escapes from the treatment

Looking at the flip side of this coin, Forbes reports

Health plans and pharmacy benefit managers (PBMs) that manage drug costs speaking at this year’s Asembia Specialty Pharmacy Summit in Las Vegas say specialty drugs now account for 50% or greater of the total prescription spending they manage. In some cases, employer clients are seeing specialty costs account for 60% or even greater of their total drug spending.

“It really is frightening for our clients,” Lucille Accetta, senior vice president of pharmacy benefit management and specialty product development at CVS Health told hundreds of attendees at the Asembia event, which runs through Thursday and drew more than 5,000 people from the healthcare industry. “We have to be the best purchaser for our clients.” * * *

To reign in the costs of prescription drugs while maintaining access to life-saving treatments, health plans and pharmacies say they are more closely monitoring patients as soon as they are on the drug, said Rina Shah, group vice president of pharmacy operations and services at Walgreens.

The Forbes article adds

Abarca Health [is] an independent PBM that manages more than $5 billion in drug costs annually for more than four million Americans has executives at this week’s Asembia meeting talking up its efforts to better manage specialty pharmacy costs.

The company’s Assura solution launched earlier this year “guarantees the net cost of drugs, including specialty medications, by offering an annual fixed per script cost for a health plan’s entire population,” Abarca said in announcing the new pricing solution earlier this year. The guarantee, Abarca CEO Jason Borschow says, is adjusted each year based on drug benefit coverage changes.

From the healthcare business front

Healthcare Dive informs us

Even as COVID-19’s benefit waned, new plan members across multiple product lines helped drive CVS to $2.3 billion in profit in the first quarter, slightly higher than the $2.2 billion brought in at the same time last year.

In results published Wednesday, the company beat Wall Street expectations on earnings and revenue, with a topline of $76.8 billion, up 11% year over year.

Fierce Healthcare explains how CVS has shifted from a retail to a digital marketing focus.

The Wall Street Journal reports

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RN

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax. * * *

Moderna is the latest drugmaker to show surging sales due to demand for Covid-19 vaccines and treatments, following recent reports fromEli Lilly & Co., Merck & Co. and Pfizer Inc.

From the health risks front, MedPage Today explains that

Seven risk factors, some modifiable and some not, accounted for the vast majority of risk for first-time acute myocardial infarction (MI) in young adults, according to a case-control study.

The seven factors — diabetes, depression, hypertension, smoking, family history of premature MI, low household income, and hypercholesterolemia — were responsible for 83.9% of the total acute MI risk in young women and 85.1% of the risk in young men, reported Harlan Krumholz, MD, SM, of Yale New Haven Hospital in New Haven, Connecticut, and colleagues.

The UPI reports

Older adults who obtain a flu shot are less likely to suffer a heart attack or stroke and are at lower risk for death from heart-related health events in the year after getting vaccinated, an analysis published Friday found.

Just under 4% of older adults vaccinated against the seasonal virus experienced a “cardiovascular event” within the next year compared to just over 5% of those who did not receive the shot, data published Friday by JAMA Network Open showed.

From the meetings department,

  • HHS provides a readout of a high-level meeting among Labor Department, health insurance and business executives “to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic, as the nation observes Mental Health Awareness Month.”
  • The National Committee for Quality Assurance reviews the presentations at last week’s Quality Talks conference.

From the federal employee benefits front, FedWeek discusses OPM’s planned improvement to processing retirement applications as unveiled in the Fiscal Year 2023 budget document. Processing federal retirement benefits will be a heavy lift for OPM until Congress simplifies the pension calculation.