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 weekly chart of new Covid cases from the 27th week of 2021 through the 24th week of 2022:
While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.
Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:
New cases and deaths are both stable. MedPage Today adds
About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.
Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.
For more information, Science discusses clues to long Covid.
Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.
Over 100,000 people aged 12 and older have received at least one booster.
Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *
The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.
The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.
The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.
From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports
Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.
From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.
From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.
From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.
From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.
New bipartisan legislation introduced in the Senate aims to empower the Federal Trade Commission (FTC) to crack down on pharmacy benefit manager practices such as spread pricing.
The legislation, introduced Tuesday, comes as the PBM industry faces other areas of reform, including a proposed rule to get rid of clawback fees PBMs can charge pharmacies after the drug is dispensed.
Lawmakers said federal agencies need more power, though, to rein in PBM practices.
From the No Surprises Act (“NSA”) front, AHIP and the Blue Cross Association inform us
A recent survey and analysis conducted by AHIP and the Blue Cross Blue Shield Association (BCBSA) found that in the first two months of 2022, the NSA prevented more than 2,000,000 potential surprise medical bills across all commercially insured patients. If only a fraction of these claims are ultimately disputed through IDR, it would still far exceed the government’s estimate. Should the trend hold, more than 12,000,000 surprise bills will be avoided in 2022 due to the NSA.
The law is working to protect millions of consumers from costly surprise bills and yet several hospital and provider organizations have filed lawsuits challenging the NSA regulations and legislation in order to increase their own profits at patients’ expense. Recent polling conducted by Morning Consult on behalf of the Coalition Against Surprise Medical Billing found that 8 in 10 voters, after learning about the NSA, are concerned that lawsuits from physician and hospital organizations could delay or overturn the patient protections in the Act.
The findings of the AHIP-BCBSA survey are important to demonstrate how many consumers have already benefitted from the NSA and to underscore the extent of total claims that could be impacted if the IDR process is not a predictable process with payment amounts that trend towards market rates.
That’s great news.
In public health news, the American Hospital Association tells us ‘
U.S. births rose 1% in 2021 to about 3.7 million, the first increase since 2014, according to preliminary data released today by the Centers for Disease Control and Prevention. Birth rates declined for women aged 15-24 and rose for women aged 25-49. The cesarean delivery rate rose 0.3 percentage point to 32.1%, while the preterm birth rate rose 4% to 10.48%, the highest rate since 2007, CDC said.
From the Omicron and siblings front
Reuters reports “The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc’s vaccine for those aged 6 months through 4 years.”
Precision Vaccines tells us “The U.S. Centers for Disease Control and Prevention (CDC) issued today Health Alert Network Health Advisory CDCHAN-00467 to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 Rebound.” COVID-19 Rebound cases have been reported to occur between two and 8 days after initial recovery. They are characterized by a recurrence of COVID-19 symptoms or a new positive viral test after testing negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the beta coronavirus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.” STAT News offers a more detailed article on this topic for those interested.
Officials for the Centers for Disease Control and Prevention (CDC) on Monday said the agency is releasing doses of a smallpox vaccine in response to the few recent cases of monkeypox that have been detected in the U.S. Jennifer McQuiston, the deputy director for the CDC’s Division of High Consequence Pathogens and Pathology, said during a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up. * * * The vaccines will be designated for people who are most likely to benefit from them, McQuiston said, including those who are known to have had close contact with monkeypox patients, health care workers and people who would be at high risk of developing a severe case of the disease.
From the healthcare business front, Beckers Hospital News identifies Walmart’s 18 Centers of Excellence in the U.S.
Third time’s a charm. Or so Democrats hope as they attempt to negotiate a third COVID-19 funding deal after their previous two bipartisan agreements — one for $15.6 billion in domestic and international aid, and a second for $10 billion in only domestic funds — stalled out.
The House is taking the lead on the latest iteration. But it’s not yet clear whether they’ll hold out for a bipartisan, bicameral agreement or attempt to move a Democrat-led version that would provide more funding, closer to President Joe Biden’s original $22.5 billion request.
“All the options are on the table,” House Majority Leader Steny H. Hoyer, D-Md., said Wednesday. “But it’s critical to get it done. And the fastest way to get it done is have an agreement on the four corners.”
From the No Surprises Act front, the U.S. Court of Appeals for the Fifth Circuit has granted the federal government/appellant’s “unopposed motion to stay further proceedings in this court pending ongoing rulemaking proceedings involving provisions of the No Surprises Act, with a status report due every sixty (60) days.” It’s worth noting that the final independent dispute resolution rule has not yet appeared on the OMB’s Office of Regulatory Affairs reginfo.gov site.
From the Omicron and siblings front, Fierce Healthcare tells us
Reported cases of COVID-19 and hospitalizations for the disease are on the rise across most of the U.S., with the Centers for Disease Control and Prevention (CDC) recently shifting many counties in the Northeast to medium or high levels of community risk. * * *
COVID-19 hospitalizations—which have become the CDC and other public health experts’ preferred metric for decisionmaking—have similarly begun to tick upward over the past month.
After reaching a seven-day average low of 1,426 daily admissions in early April, national admissions have continually increased and exceeded the seven-day average of 2,400 daily hospitalizations late last week. These new admissions represented an 11% increase over the previous week’s seven-day average, according to the agency, but were still nearly 90% below the January peak of more than 21,500 average daily admissions.
From the opioid epidemic front, the Wall Street Journal reports
Drug-overdose deaths in 2021 topped 100,000 for the first time in a calendar year, federal data showed, a record high fueled by the spread of illicit forms of fentanyl throughout the country.
More than 107,000 people in the U.S. died from drug overdoses last year, preliminary Centers for Disease Control and Prevention data released Wednesday showed, roughly a 15% increase from 2020. The proliferation of the potent synthetic opioid fentanyl has been compounded by the destabilizing effects of the Covid-19 pandemic on users and people in recovery, according to health authorities and treatment providers.
“We’ve never seen anything like this,” said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics, regarding fentanyl’s impact on the numbers.
From the telehealth front, Healthcare Dive informs us
Telehealth visits for COVID-19 diagnoses fell in February, mirroring the sharp decline in new cases of the virus reported to the Centers for Disease Control and Prevention after January’s omicron-driven peak, according to Fair Health’s monthly telehealth claims tracker.
Overall telehealth use also slowed, falling 9.3% in February across the country. Virtual visits were 4.9% of all medical claim lines, down from 5.4% in the prior month.
With declining COVID-19 cases generating fewer telehealth sessions, mental health conditions accounted for a greater share of all diagnoses conducted via virtual platforms, according to the Fair Health data released Monday. Mental health diagnoses rose to about 64% of telehealth claims, up from 60% in January.
The FEHBlog is happy that people are using telehealth for mental healthcare,e which strikes the FEHBlog as a good, productive fit.
From the healthcare business front, Healthcare Dive reports
Advocate Aurora Health and Atrium Health said Wednesday they plan to merge, creating one of the nation’s largest nonprofit health systems with $27 billion in combined revenues and 67 hospitals across six states.
Board members from both systems unanimously approved the agreement, which is subject to regulatory review. The combined entity will be led by both CEOs for the first 18 months, at which time Advocate’s CEO Jim Skogsbergh will retire, leaving Atrium’s CEO Eugene Woods as sole leader.
Advocate and Atrium will have an equal number of board seats. Atrium’s board chair Edward Brown will first serve as chair until the end of 2023, followed by a two-year term for Advocate’s chair Michele Richardson.
The new organization will have a combined footprint across Illinois, Wisconsin, North Carolina, South Carolina, Georgia and Alabama. It will serve 5.5 million patients, operate more than 1,000 sites of care and 67 hospitals, employ more than 7,600 physicians and nearly 150,000 teammates, and have combined annual revenues of more than $27 billion.
KLAS launched the Payer/Provider Initiative to identify points of friction between payers and providers and to highlight strong collaboration case studies.
The six payer-provider challenges that leading healthcare organizations tackled were prior authorization, value-based care, payer-provider interoperability, denials, credentialing, and patient billing.
Agencies have to choose two out of four new focus areas to help improve their workforce over the next four years.
Deciding which options are most impactful gives agencies flexibility in how they approach new workforce objectives from the Office of Personnel Management.
Although OPM’s federal workforce priorities report, released on May 10, asks agencies to focus on only two of the four focus areas, implementing all four can help agencies resolve bigger workforce issues.
Among four primary priorities and four enabling priorities, OPM hopes agencies can implement proactive approaches to common issues, such as recruitment challenges.
From the Omicron and siblings front, Fortune Well explores earlier pandemics for similarities to our current one.
As U.S. COVID czar Dr. Anthony Fauci and colleagues pointed out in a 2009 New England Journal of Medicine article, “It is not generally appreciated that descendants of the H1N1 influenza A virus that caused the catastrophic and historic pandemic of 1918–1919 have persisted in humans for more than 90 [now 100] years and have continued to contribute their genes to new viruses, causing new pandemics,” including the 2009 H1N1 “swine flu.”
“We are living in a pandemic era that began around 1918,” they wrote 13 years ago—long before the advent of COVID-19.
Pfizer Inc. expects demand for its Covid-19 antiviral drug to increase as governments return to replenish their supplies and seek to thwart surges as the pandemic virus continues to evolve.
The treatment, a pill called Paxlovid, brought in $1.5 billion in sales during Pfizer’s first quarter, while its vaccine totaled $13.2 billion, reflecting the need for tools to combat the virus despite a slowdown in cases and a growing sense of life trying to return to normal.
The company said Tuesday it is on track to deliver between $98 billion and $102 billion in revenue for the year, with $32 billion coming from its Covid-19 vaccine Comirnaty and $22 billion from Paxlovid.
“We remain bullish on Paxlovid” said Chief Financial Officer Frank D’Amelio on a call discussing earnings with analysts. “The rhythm of that product looks very good.”
Biogen is replacing CEO Michel Vounatsos, the company said Tuesday, ending a five-year tenure in which he presided over the disastrous approval and rollout of its Alzheimer’s treatment, Aduhelm.
The company also said it is “substantially eliminating” all spending on Aduhelm just 10 months after securing U.S. approval — a concession from the struggling biotech that the drug had become a financial liability following a Medicare decision to restrict patient access and payment.
From the Affordable Care Act front, Health Affairs Forefront features the third and final part of Katie Keith’s series on the final 2023 notice of benefit and payment parameters. The third part discusses changes to the ACA marketplace’s risk adjustment program.
From the No Surprises Act, the FEHBlog had understood that the NSA regulators planned to release a final rule on the NSA’s arbitration process, replacing the interim final rule, this month. However, a Justice Department filing with the U.S. Court of Appeals for the Fifth Circuit submitted late last week states, “the Departments expect to issue a final rule early this summer that will supersede the portions of the interim final rule that Plaintiffs [in the Texas Medical Association case] challenged.” No wonder then that the final rule has not been presented yet to OMB’s Office of Information and Regulatory Affairs for its required review before publication in the Federal Register.
From the No Surprises Act front, the FEHBlog nearly fell off his chair when he noticed this Healthcare Dive article:
The Department of Justice intends to appeal a federal judge’s ruling that sided with providers over a challenge to the surprise billing rule, according to a Friday filing from the DOJ in the Eastern District of Texas.
The Texas Medical Association sued the federal government over its interpretation of the No Surprises Act, arguing the rule leans too heavily on one factor arbiters are supposed to consider when resolving payment disputes between payers and providers.
Federal Judge Jeremy Kernodle’s February ruling said nothing in the bill passed by Congress instructs arbiters to “weigh any one factor … more heavily than the others,” indicating the rule conflicts with the bill.
The Justice Department noticed an appeal to the Fifth Circuit in the referenced Friday, April 22, filing with the District Court. That notice effectuates the appeal. The FEHBlog will keep an eye on the dockets to learn whether the Justice Department will seek a stay of the February ruling while the case is on appeal.
From the Omicron and siblings front —
Bloomberg’s Prognosis reviews progress being made in the development of Covid vaccines administered nasally. Nasal vaccines have a better shot at preventing COVID than injected vaccines.
The American Hospital Association reports “The Food and Drug Administration today expanded its approval for remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.”
Medical Dialogues informs us the World Health Organization has recommended Pfizer’s Paxlovid Covid pill over remdesvir, Merck’s pill and monoclonal antibodies for patients with milder forms of Covid and nevertheless at high risk of hospitalization from the disease, e.g. the elderly, the immunocompromised, and the unvaccinated.
WebMD News tells us “COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the CDC said Friday. * * * The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.”
The WebMD article offers other interesting public health nuggets. For example,
About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.
Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.
Overall, about 3,458,697 deaths were reported in the U.S. last year. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of .7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.
From the healthcare business front, Fierce Healthcare reports
Change Healthcare has found a buyer for its payment integrity arm, ClaimsXten, though the sale is contingent on the closure of its merger with UnitedHealth Group.
According to a filing submitted Monday to the Securities and Exchange Commission, ClaimsXten will be sold off to an affiliate of TPG Capital for a base purchase price equal to $2.2 billion in cash. UnitedHealth is listed as the seller.
From the reports department —
The National Bureau of Economic Research offers a working paper titled “Pharmacy Benefit Managers and Vertical Relationships in Drug Supply: State of Current Research.”
Per HR Morning, “Employer support [of their workforces] is happening in the areas of increased prioritizing employee assistance programs (EAPs), expanded wellness benefits and greater attention to work/life balance. That’s according to Ragan’s 2022 Communications Benchmark Report that surveyed close to 1,000 communicators across industries on opportunities and changes.”
The Centers for Disease Control and Prevention on Wednesday asked the Justice Department to appeal a federal judge’s ruling overturning the federal mask mandate for airlines and other forms of public transportation, setting up a legal battle that could permanently impact the CDC’s ability to weigh in on public health issues.
The judge’s ruling was the latest in a series of court decisions that have left the Biden administration with dwindling legal options for mandates to combat Covid-19. And it came amid a shift away from mask mandates in the U.S., even in Democratic-controlled states along the East and West coasts. An appeal gives the Biden administration the opportunity to persuade a higher court to wipe the Florida ruling off the books, which could prove useful to the White House if it chooses to pursue a mask mandate in the future.
A new U.S. government center [residing within the CDC] aims to become the National Weather Service for infectious diseases — an early warning system to help guide the response to COVID-19 and future pandemics.
The new Center for Forecasting and Outbreak Analytics launched Tuesday. Its leaders say predicting the course of the COVID-19 pandemic in the U.S. has been hampered by data-collection problems.
In contrast, the United Kingdom uses regular population sampling with swab tests and blood draws to get a clearer picture of who’s been infected, said Marc Lipsitch, the new center’s science director. He said similar sampling should be considered in the U.S.
And the Centers for Disease Control and Prevention needs to have better access to data from state governments and hospitals, said Caitlin Rivers, the center’s associate director.
From the Omicron front, STAT News discusses six Covid mysteries that scientists are beginning to unravel.
Hospitalization rates for unvaccinated children ages 5 to 11 were twice as high as among those who were vaccinated during the record COVID-19 surge caused by the Omicron variant, according to a U.S. study released on Tuesday.
For every 100,000 unvaccinated children in the age group, 19.1 per were hospitalized with COVID-19 between mid-December and late February, compared with 9.2 per 100,000 vaccinated kids, the U.S. Centers for Disease Control and Prevention reported.
From the Social Determinants of Health front,
The Center for Medicare Services “outlined an action plan that demonstrates the Biden-Harris Administration’s ongoing efforts to provide high-quality, affordable health care for all people, regardless of their background, and to drive health equity across the Department of Health and Human Services (HHS).”
“The goals of CMS’ action plan include:
Promoting culturally and linguistically appropriate services in organizations;
Enrolling more people in Medicare, Medicaid, the Children’s Health Insurance Program and Health Insurance Marketplace; and
Incorporating screening for and promoting broader access to health-related social needs.”
The CDC’s Division of Diabetes Translation called attention to its new website on improving health equity
From the No Surprises Act front, the American Medical Association offers an article on how doctors can use the NSA to resolve billing disputes. It’s always helpful to take a peek at the other sides’s strategies.
Beginning in August, Kaiser Permanente commercial HMO and exclusive provider organization (EPO) members who need urgent care when they are traveling outside of areas served by Kaiser Permanente will have access to Cigna’s national PPO network of more than one million physicians and other providers. This will significantly expand Kaiser Permanente’s ability to provide more affordable and convenient access to valuable, high-quality health care and services for current and future members.
This is a smart move by KP to reduce its exposure to NSA emergency department billing disputes.
In the area of specialty pharmacy services, the agreement seeks to deliver overall value and savings to Kaiser Permanente and its commercial plan members. Accredo, Evernorth’s specialty pharmacy, will become Kaiser Permanente’s preferred external pharmacy for limited distribution drugs, and Evernorth’s CuraScript SD will be a preferred distributor for purchasing certain other specialty products.
The broad agreement between Evernorth and Kaiser Permanente is effective immediately.
Anthem’s first-quarter profits reached $1.8 billion thanks to strong enrollment in its Medicaid and Medicare Advantage plans.
Anthem, which operates an array of government and commercial health insurance including Blue Cross and Blue Shield plans in 14 states, Wednesday reported first-quarter profits rose 8.4% to $1.8 billion, or $7.39 per share, compared to $1.67 billion, or $6.71 per share, in the year-ago quarter. Revenue rose nearly 17.6% to $38 billion compared to $32,4 billion a year ago.
Anthem’s membership grew by 3.3 million, or 7.5%, to 46.8 million as of March 31, 2022, compared to a year ago.
According to the report, only 4.6% of hospitals were sold over the period. Small hospitals with 26-64 beds were more likely to be acquired than larger hospitals, and hospitals with the greatest negative margins were over twice as likely as those with the highest positive margins to be acquired (8.6% versus 3.0%). Only one critical access hospital was acquired during the study period, and urban hospitals were more likely to be acquired than rural hospitals (5.6% versus 3.3%). Long-term care hospitals were the most likely to be acquired, while psychiatric and “other” hospitals were the least likely.
The agency plans to update the data on a quarterly basis.
When comparing the use of telehealth among different pediatric subspecialties, a JAMA Network Open study found that pediatric telehealth use was inconsistent across subspecialties, with genetics and behavioral health subspecialists using the care modality the most.
The study included 549,306 patients, representing a total of 1.8 million visits from eight pediatric medical groups from the Children’s Specialty Care Coalition (CSCC). There were 11 different subspecialties, including cardiology, orthopedics, urology, nephrology, dermatology, genetics, behavioral health, pulmonology, endocrinology, gastroenterology, and neurology. The study period began Jan. 1, 2019, and ended Dec. 31, 2021.
Scientists around the world are discovering and tracking newer forms of the Omicron coronavirus variant, showing how even when a strain becomes globally dominant, it continues to evolve and can splinter into different lineages.
Case in point: Updated data released Tuesday showed that a burgeoning form of Omicron, called BA.2.12.1 — itself a sublineage of the BA.2 branch of Omicron — now accounts for nearly one in five infections in the United States. It’s eating into the prevalence of the ancestral BA.2, highlighting the emergent virus’s transmission advantage over its parent. BA.2 now accounts for about 74% of cases, while the remaining 6% or so are from the BA.1 branch of Omicron, the first form of the variant that took over globally and whose prevalence has been falling as BA.2 became dominant.
The menagerie can be dizzying to track, especially because all these cases technically fall under the Omicron umbrella. But even as scientists closely monitor the divergence of Omicron, early signs suggest the different lineages don’t substantially differ in terms of how virulent they are or in their ability to evade the protection generated by immunizations. While some of the newer forms of the virus might be better spreaders than others, their emergence doesn’t necessarily result in huge increases in cases.
David Leonhardt adds in his New York Times morning column today
In several places where the number of cases has risen in recent weeks, hospitalizations have stayed flat. (In past Covid waves, by contrast, hospitalizations began rising about a week after cases did.) * * *
Even if hospitalizations do rise in coming weeks, a declining share of coronavirus cases that result in serious illness would be very good news, Dr. Craig Spencer, director of global health in emergency medicine at Columbia University, has pointed out.
I haven’t seen a Covid patient in the E.R. in weeks and go to work now expecting not to,” Spencer told me, “despite a swirl of Covid in the community.”
Among other things, a decoupling of cases and severe illness would mean that hospitals were less likely to become overwhelmed during future Covid surges. When hospitals avoid getting swamped, they can provide care to every patient who needs it — which becomes another factor that reduces bad health outcomes.
For these reasons, Mr. Leonhardt plans to shift his focus from new cases to new hospitalizations.
Because mRNA-based vaccines are a relatively new class of vaccines, they do not include the traditional adjuvants. The current mRNA vaccines used in the U.S. rely on small balls of fat called lipid nanoparticles to deliver the mRNA. These lipid molecules can act as adjuvants, but how precisely these molecules affect the long-term immune response remains to be seen. And whether the current COVID-19 vaccines’ failure to trigger strong long-lived antibody response is related to the adjuvants in the existing formulations remains to be explored.
While the current vaccines are highly effective in preventing severe disease, the next phase of vaccine development will need to focus on how to trigger a long-lived antibody response that would last for at least a year, making it likely that COVID-19 vaccines will become an annual shot.
New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters.
At a hearing of a Food and Drug Administration advisory panel earlier this month, experts fretted about exactly how governments should make decisions about the composition of annual boosters. And they were adamant that governments, not pharmaceutical companies, should be deciding the strain composition of the shots, as the World Health Organization does for influenza shots. But these data are a reminder that those decisions can be tough. What would experts do when faced with booster shots with several different compositions? Will adding new strains work similarly for different types of vaccines? There are a huge number of open questions.
There’s also the biggest problem with annual flu shots: People don’t get them. Even with the current Covid boosters, this has been true. Data presented to the FDA panel said that 217 million Americans are vaccinated about Covid. But only 90 million people have received a booster dose. How many will turn out for a new booster next year?
Look at this comparison of winter 2019-2020 flu vs. 2020-2021 Covid
2019 – 2020 Winter CDC Fluview
2020-2021 Winter COVID-19
10/1/2020 to 3/21/2021
Deaths over total cases
Who would look back on pre-Covid flu as the good old days? But comparatively, it is. We see millions more flu cases, but hundreds of thousands fewer flu deaths.
Kaiser Health News discusses the need for better ventilation in office buildings which could help tamp down Covid and flu cases. “The science is airtight,” said Joseph Allen, director of the Healthy Buildings program at Harvard University’s T.H. Chan School of Public Health. “The evidence is overwhelming.”
From the No Surprises Act front, Healthcare Dive reports
The online portal for resolving payment disputes between payers and providers for certain out-of-network charges is now open, the CMS said Monday. The portal initiates what’s known as the federal independent dispute resolution process, a key part of the No Surprises Act that outlaws balance bills in most cases. As a last resort, it allows payers and providers to resolve payment disputes using an arbitration style similar to the model adopted by Major League Baseball in salary negotiations.
From the transparency in coverage rule front, the Labor Department issued ACA FAQ 53 today. FAQ 53 provides guidance to health plans, including FEHB plans, on how to post three machine-readable pricing files on their website. The Labor Department will begin to enforce this requirement on July 1, 2022.
Commercial health plans pay higher prices than public payers for hospital care, which accounts for more than 5 percent of US gross domestic product. Crafting effective policy responses requires monitoring trends and identifying sources of variation. Relying on data from the Healthcare Provider Cost Reporting Information System, we describe how commercial hospital payment rates changed relative to Medicare rates during 2012–19 and how trends differed by hospital referral region (HRR). We found that average commercial-to-Medicare price ratios were relatively stable, but trends varied substantially across HRRs. Among HRRs with high price ratios in 2012, ratios increased by 38 percentage points in regions in the top quartile of growth and decreased by 38 percentage points in regions in the bottom quartile. Our findings suggest that restraining the growth rate of HRR commercial hospital price ratios to the national average during our sample period would have reduced aggregate spending by $39 billion in 2019.
Seniors save nearly $2,000 on average a year in total healthcare spending in Medicare Advantage (MA) compared to fee-for-service Medicare, a new study finds.
The study, published Tuesday, by the advocacy group Better Medicare Alliance finds that seniors spent $1,965 less including premiums and out-of-pocket costs on MA when compared to fee-for-service.
“We see particularly strong results for historically disadvantaged populations, including Black and Hispanic beneficiaries and those who are low-income,” said Allison Rizer, principal at the consulting firm ATI Advisory, which performed the study that examined 2019 Medicare Current Beneficiary Survey data.
From the healthcare business front, Fierce Healthcare tells us
UnitedHealth Group executives said Thursday that its Optum Health subsidiary, which is one of the country’s largest physician groups, is building out value-based care partnerships at a faster rate than was expected.
In its earnings report, the healthcare giant said it initially projected that 500,000 new patients would be treated in value-based arrangements. It’s upping that projection to 600,000. Wyatt Decker, M.D., CEO of Optum Health, said on the company’s earnings call that reflects Optum’s efforts to invest in technology, analytics and building networks are paying off.
“What you’re really seeing is a result of almost 10 years of building a flywheel that now has significant momentum,” Decker said. “All of that continues to yield benefits and, frankly, growth.”
The severity of multiple sclerosis (MS) was linked with geographic latitude, an observational study showed.
Among 46,000 MS patients living in temperate zones, more severe disease was seen in those who lived above 40° latitude, reported Tomas Kalincik, MD, PhD, of the University of Melbourne, Australia, and co-authors.
The association was driven mainly, but not exclusively, by ultraviolet B (UVB) radiation exposure contributing to both MS susceptibility and severity, the researchers wrote in Neurology.
AHRQ discusses a study on “Geographic Variation in Inpatient Stays for Five Leading Substance Use Disorders, 2016-2018.” There are interesting State variations.
From the Omnicron and siblings front, the Wall Street Journal reports encouraging news.
The Omicron BA.2 variant has dominated new infections in the U.S. for weeks without setting off a major surge so far, raising hopes among some public-health experts that the nation might dodge a more significant hit.
BA.2 is in particular affecting the Northeast, where virus concentrations in wastewater are rising alongside reported infections in such places as New York, Washington, D.C., and Philadelphia. Concern about BA.2 prompted Philadelphia to restore an indoor-mask requirement and U.S. authorities to extend mask mandates for airplanes and other forms of transportation.
Still, BA.2 hasn’t yet caused the rise in hospitalizations some doctors said they would have anticipated. Disease experts say some combination of immunity from Covid-19 vaccinations and a severe wintertime surge, aided by springtime weather drawing people outdoors, might be keeping the virus at bay.
A booster dose of the Pfizer-BioNTech COVID-19 vaccine was safe and produced an immune response in kids ages 5 to 11, including against the Omicron variant, the companies said on Thursday.
These data came from two sources: the phase II/III clinical trial on 140 children ages 5 to 11 who received a booster dose at least 6 months after their two-dose primary series, and a subgroup of 30 kids in whom response against Omicron was studied specifically. In this subgroup analysis, there was a 36-fold increase in neutralizing antibody titers compared with levels seen after the two-dose primary series, the companies reported.
The companies plan to submit a request to the FDA for an emergency use authorization (EUA) for a third dose for this age group “in the coming days.” The agency previously authorized a two-dose primary series of the 10 μg formula for this age group in October 2021.
Health IT Analytics tells us, “When comparing groups that experienced the worst effects of COVID-19, a study published in Public Health Nursing found that the pandemic had a significant impact on those who exhibit high social vulnerability, leading them to have the highest mortality levels.” This finding illustrates the importance of resolving health disparities.
More than 90 federal agencies released their first-ever equity action plans on Thursday, laying out more than 300 strategies to better help underserved communities. This follows an executive order President Biden issued on day one of his administration, which directed agencies to conduct equity assessments of their top three to five high-impact services for Americans to determine where there were systematic barriers. These findings helped agencies develop their plans.
“Taken together these 300 actions demonstrate what it means to take a whole-of-government approach to advancing equity,” said a senior administration official on a background briefing call. “For the first time Americans will see a full picture of what it looks like for the entire federal government to advance equity at once.”
In a significant development from the No Surprises Act front, the Affordable Care Act regulators issued helpful Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties and Certified IDR Entities. The new guidance no longer treats the Qualifying Payment Amount as a rebuttable presumption. This action strongly suggests that the QPA’s rebuttable presumption status will be removed from the “final, final” version of the IDR rule. That regulation is due out next month. However, the rule does not yet appear on the OMB Office of Information and Regulatory Affairs’ list of rules currently being subjected to their oversight.
In other regulatory news, the International Foundation of Employee Benefits Plans alerts us,
The Department of Justice (DOJ) released guidance including frequently asked questions (FAQs) on how the Americans with Disabilities Act (ADA) protects individuals from discrimination when they are being treated for and recovering from opioid use disorder (OUD).
A group of 30 bipartisan lawmakers sent letters to 7 naloxone manufacturers, calling on them to apply for over-the-counter status for their opioid overdose antidotes and open up supplies further as the opioid crisis continues in the US with record levels of overdoses and deaths.
Citing a Massachusetts study that found substantially increased access to naloxone reduced opioid overdose mortality rates by 46%, the senators and representatives called on Pfizer, Teva Pharmaceuticals, Adamis Pharmaceuticals, Akorn, Amphastar Pharmaceuticals, Emergent BioSolutions, and Hikma Pharmaceuticals to “submit applications to make naloxone available over the counter without delay.”
Currently, there are three FDA-approved forms of naloxone — injectable, auto-injector and nasal spray — and all three currently require a prescription, but in most states and the District of Columbia pharmacists are allowed to dispense naloxone under a standing order, meaning they don’t actually need individual prescriptions. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers.
Good idea. The HHS Secretary Xavier Becerra extended the opioid epidemic public health emergency for another 90 days earlier this month.
From the healthcare business front, Healthcare Dive reports on UnitedHealth Group’s 1st Quarter 2022 financial results.
UnitedHealth is bullish on completing its controversial acquisition of data analytics firm Change Healthcare, despite legal action from the Department of Justice to block the deal.
UnitedHealth’s extended agreement with Change “reflects our firm belief in the potential benefits of this combination to improve healthcare and in our ability to successfully overcome the challenge to this merger,” Chief Operating Officer Dirk McMahon told investors on a Thursday morning call regarding first-quarter financial results.
The Minnetonka, Minnesota-based healthcare behemoth beat Wall Street expectations for earnings and revenue in the quarter, with a topline of $80.1 billion, up 14% year over year due to double-digit growth at health services arm Optum and payer business UnitedHealthcare. Net earnings were $5.1 billion, up 3% year over year. UnitedHealth raised its full-year guidance following the results.
The Omicron surge didn’t lead to an explosion of medical claims at UnitedHealth Group, which contributed to higher-than-expect profits. UnitedHealth ended the first three months of the year with more than $5 billion of profit on $80.1 billion of revenue. The company’s medical loss ratio, which shows the percentage of insurance premiums that were spent on medical claims, was 82% — higher than 80.9% in the first quarter of 2021, but less than what Wall Street expected.
From the miscellany department
The ICD 10 Monitor discusses “two extremely encouraging studies in terms of the content coverage and feasibility of replacing ICD-10-CM with ICD-11.”
BioPharma Dive reports “AbbVie and Genmab said treatment with their dual-acting antibody epcoritamab led to responses in nearly two-thirds of patients with lymphoma, announcing on Wednesday that their clinical trialsurpassed its benchmark for success. The partners will now take the data to the Food and Drug Administration and other regulators to determine whether it’s good enough to formally submit for approval.”
Health Data Management offers useful insights into the ongoing TEFCA launch.
A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.
The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand.
Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.
The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.
The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.
But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.
They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.
Here is a link to the CMS fact sheet on this decision.
U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.
From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.
From the healthcare business front, Fierce Healthcare informs us
[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.
At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.
The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”
Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.
Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.
St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.
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 weekly chart of new Covid cases from the 27th week of 2021 through the 12th week of 2022:
In the current CDC Covid Data Weekly Tracker, the CDC explains
In February, CDC’s COVID Data Tracker released a Wastewater Surveillance tab, which tracks changes and detections of SARS-CoV-2 viral RNA levels at more than 600 testing sites across the country. Because many people with COVID-19 shed the virus in their feces, wastewater testing can help us monitor COVID-19 in communities. Virus levels in wastewater usually increase four to six days before clinical cases increase, so surveillance results can help communities act quickly to prevent the spread of COVID-19.
Currently, virus levels in wastewater are relatively low across the country. More than half of all sites reporting wastewater data are experiencing a decrease in SARS-CoV-2 levels, but some have reported a modest uptick. These upticks may reflect minor increases from very low levels to levels that are still low. It’s important to note that even a small increase when levels are very low can appear like a dramatic increase in the percent change. However, there is a possibility that some communities might start to see an increase in COVID-19 cases. This could happen for a variety of reasons, like waning immunity, new circulating strains, and eased prevention strategies.
Right now, it’s too early to know if we’ll see a corresponding increase in reported cases across the country. Wastewater data are meant to be used with other COVID-19 surveillance data. CDC encourages local public health officials to watch for sustained increasing levels of the virus in wastewater, and to use wastewater surveillance data with other kinds of data to inform their decisions. CDC continues to encourage people to use COVID-19 Community Levels to find out what actions they should take to protect themselves and others. The whole community can be safe only when we all take steps to protect each other.
Using the same approach, here is the FEHBlog’s latest weekly chart of Covid deaths:
[T]he 2022 trend data from the CDC indicates pneumonia may soon overtake COVID-19 as the leading cause of respiratory death in the U.S.
Historically, the CDC reported the number of visits to emergency departments with pneumonia as the primary diagnosis averaged about 1.5 million, which led to 47,000 deaths annually.
The good news is pneumonia is a vaccine-preventable disease.
Unfortunately, the percentage of adults who had ever received a pneumococcal vaccination was 25.5% in 2020.
Increasing the pneumococcal vaccination rate is a worthy goal for health plans and primary care providers.
Here’s is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered in the Covid vaccination era:
While recent vaccinations numbers are nothing to crow about, over 75% of Americans age 18 and older are fully vaccinated. Nearly half of the same population and over two-thirds of Americans age 65 and older have received a booster.
The Biden administration could authorize a second Covid-19 booster shot for older Americans within weeks, amid rising concern over a potential resurgence of cases, four people with knowledge of the matter told POLITICO.
The move under consideration by senior health officials would recommend the additional vaccine dose for adults 65 and older, in an effort to better protect high-risk people and stave off a wave of hospitalizations should infections climb rapidly as a result of the spread of the Omicron subvariant, BA.2. Currently, second boosters are only recommended for those with compromised immune systems.
From the No Surprises Act front, last Monday, Federal District Judge Richard Leon heard oral argument on dispositive cross-motions submitted by medical associations and the federal government regulators concerning the status of the qualifying payment amount in the baseball arbitration process. The FEHBlog has heard from a couple of sources who attended the hearing that Judge Leon indicated that he does not plan to put deciding the case on his front burner because the federal regulators advised him about their intent to issue the final, final rule on the Independent Dispute Review process in May 2022. The case is pending in the U.S. District Court for the District of Columbia.
From the telehealth front, mHealth Intelligence informs us
More than two-thirds of telehealth providers said they use audio-only modalities to offer telehealth services, according to a recent survey conducted by the American Medical Association.
The popularity of telehealth among physicians is apparent, with 85 percent saying they still use it. But 52 percent agreed that their telehealth usage has decreased since they first started offering the services. The top reason for the decrease was that they moved to a hybrid model of care with both in-person and virtual care services.
The company confirmed the deal in a statement to the outlet. The acquisition has not been announced publicly as of yet.
“Optum and Refresh Mental Health are excited to expand effective behavioral care to patients through a more coordinated health system,” the company said in a statement to Axios. * * *
Refresh was founded in 2017 and provides outpatient mental and behavioral health services. It runs 300 locations across 37 states that offer a variety of services including psychiatry and substance abuse treatment.
Bicycle Health, a virtual provider for opioid use disorder, is partnering with five additional payers, it said in an announcement provided exclusively to Fierce Healthcare.
The partnerships are with Molina Healthcare and McLaren Health Plans in Michigan, UHC Community Plan in Arizona, Health First Colorado (the state’s Medicaid program) and Blue Cross Blue Shield Texas. In total, these payer partnerships have the potential to reach more than 8 million patients, the company said. Coverage will include medication management, behavioral health (individual or group psychotherapy, medical care), support groups and care coordination.
“From high costs to significant time commitments, many traditional OUD recovery programs just aren’t realistic options for the vast majority of patient experiences,” Bicycle Health CEO and founder Ankit Gupta said in a statement. “We are committed to making science-based, holistic OUD treatment accessible to all who need it—and these partnerships are an exciting step towards that goal.”