Happy Juneteenth (observed)! Here are a few items that came to the FEHBlog’s attention today
From the Omicron and siblings front —
The New York Times informs us that “Despite Another Covid Surge, Deaths Stay Near Lows. Most Americans now carry some immune protection, experts said, whether from vaccines, infection or both.” Amen to that.
While the Food and Drug Administration has given emergency use authorization to Moderna’s vaccine for ages 6 to 17, the Centers for Disease Control has not yet ratified that decision so Pfizer’s vaccine remains the only vaccine available to that age group for now.
When previously healthy little kids started showing up in hospitals with failing livers last fall and this spring, startled doctors and public health authorities didn’t know what was behind what they were seeing. They also didn’t know if what they were seeing was new. * * *
Now scientists at the Centers for Disease Control and Prevention have come up with some estimates for the normal rate of this condition, at least in the United States. Their findings, published earlier this week in the online journal Morbidity and Mortality Weekly Report, may come as a surprise.
Their research suggests there has not been an increase in cases of pediatric hepatitis of unknown origin, at least in the United States. Nor has there been a rise in the number of pediatric liver transplants, which a portion of these children have needed. Likewise, the rate of detections of infections caused by adenovirus 41 — a stomach bug virus that has been implicated as a potential trigger of these hepatitis cases — has not changed over time, the CDC scientists reported. * * *
With rates unchanged since before the Covid-19 pandemic, a theory espoused by scientists from Israel — that this is some sort of post-Covid condition — becomes harder to argue.
“It doesn’t mean that Covid still can’t have some collateral role with all of this. But I think these kind of data helps support that that’s probably not the cause,” explained veteran epidemiologist Michael Osterholm, who was not involved in the CDC work.
That’s encouraging news.
The Society for Human Resource Management tells us about its 2022 Employee Benefits Survey.
“Employer rankings of the importance of benefits shifted drastically in 2020 as they made pandemic-inspired adjustments, but these rankings have returned to an order like that seen pre-pandemic as businesses regain a semblance of normal operations,” said Daniel Stunes, senior researcher at SHRM.
Significantly, however, “all benefit types were rated by employers as more important to offer today than before the COVID-19 pandemic,” Stunes said, reflecting an increased appreciation for the role benefits play in fostering employee well-being and in attracting and keeping talent in a tight labor market.
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.
From the Omicron and siblings front, the Wall Street Journal reports
A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.
The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.
A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.
The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.
An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.
Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.
From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us
** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.
** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.
Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.
Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company.
This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.
“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”
From the Rx coverage front, the Food and Drug Administration announced
the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.
From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced
issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *
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 23rd week of 2022.
The CDC’s weekly review of its Covid statistics observes “As of June 8, 2022, the current 7-day moving average of daily new cases (109,032) increased 8.0% compared with the previous 7-day moving average (100,916).”
Here’s is the CDC’s latest weekly report of new Covid hospitalizations:
The CDC’s weekly review notes “The current 7-day daily average for June 1–7, 2022, was 4,127. This is an 8.0% increase from the prior 7-day average (3,820) from May 25–31, 2022.”
Here’s the FEHBlog’s weekly chart of new Covid deaths over the same period as new cases:
The CDC’s weekly review adds “The current 7-day moving average of new deaths (306) has increased 18.6% compared with the previous 7-day moving average (258).” Over 2/3s of the U.S. population is now fully vaccinated.
Here’s the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era at the 51st week of 2020 through the 23rd week of 2022:
The CDC’s weekly review states “As of June 8, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 290,078, a 15.6% decrease from the previous week.”
The American Hospital Administration adds
An initial 10 million doses of COVID-19 vaccine are available for children under age 5 if the Food and Drug Administration authorizes and the Centers for Disease Control and Prevention recommends the Pfizer and Moderna vaccines for children in this age group, Assistant Secretary for Preparedness and Response Dawn O’Connell said yesterday during a White House briefing.
FDA’s vaccine advisory committee will meet June 14-15 and the CDC’s advisory committee June 17-18 to consider whether to authorize and recommend the vaccines for this age group, after which the agencies will issue their respective decisions.
“It will take some time to position these vaccines across the country, and vaccinations can’t begin until CDC has made its decision,” O’Connell said. “But we also know that many parents have been waiting for a long time, so we will be working 24/7 until every dose is shipped and delivered.”
The Administration last week opened pre-ordering of doses for states, tribes, territories and other partners, and estimates that 85% of children under 5 live within 5 miles of a potential vaccination site, she said.
The CDC’s weekly review sums things up as follows:
As of June 9, 2022, there are 314 (9.75%) counties, districts, or territories with a high COVID-19 Community Level, 1,052 (32.67%) counties with a medium Community Level, and 1,854 (57.58%) counties with a low Community Level. This represents a small (+2.20 percentage points) increase in the number of high-level counties, a moderate (+9.57 percentage points) increase in the number of medium-level counties, and a corresponding (−11.77 percentage points) decrease in the number of low-level counties. Fifty-two (100%) of 52 jurisdictions* had high- or medium-level counties this week.
From the unusual viruses front, the American Hospital Association tells us
The Centers for Disease Control and Prevention today reported over 1,300 monkeypox cases globally, including 45 in the United States. While no deaths have been reported and the overall risk to the U.S. public remains low, officials encouraged clinicians to review the CDC’s latest guidance and individuals to talk with their health care provider if they develop symptoms or need to get tested.
According to CDC, monkeypox spreads through direct contact with an infected person’s body fluids, sores or materials that have touched them, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.
Smallpox vaccines are effective at protecting people against monkeypox when given before exposure and may also help prevent the disease or make it less severe. According to CDC, the Strategic National Stockpile currently holds about 72,000 doses of JYNNEOS smallpox vaccine and will soon receive an additional 300,000 doses from the manufacturer. The U.S. also has ordered another 500,000 doses for delivery later this year. In addition, the SNS holds over 100 million doses of an older smallpox vaccine (ACAM2000).
From the electronic health record front, Beckers Hospital News reports
Oracle’s primary mission is improving the complex healthcare system with technology, according to Larry Ellison.
The chair, co-founder and chief technology officer of Oracle said in a June 9 virtual public presentation the company plans to vastly improve care delivery, outcomes and public health policy while also lowering costs. Oracle acquired Cerner in a $28.4 billion transaction earlier this week and has plans to modernize the platform, taking it from a documentation and billing system to a complete source of information about an individual’s healthcare. The EHR would also have virtual care capabilities, be interoperable and expand clinical trial accessibility.
“Together, Cerner and Oracle have all the technology required to build a revolutionary new health management information system in the cloud,” Mr. Ellison said. “That system will deliver much better information to healthcare professionals. Better information will fundamentally transform healthcare.”
Oracle aims to build a unified database for patient information, similar to the unified financial database with credit information, accessible to healthcare providers and public health officials. The database would have anonymized data from hospitals, clinics and providers across the U.S. and provide up-to-the-minute information about patients’ personal health as well as public health statistics, such as the number of people hospitalized with COVID-19 or available hospital beds in a particular state.
“We’re building a system where the health records, all American citizens’ health records, not only exist at the hospital level, but they are all in a unified national healthcare database,” Mr. Ellison said. “The national database solves the data electronic health record fragmentation problem.”
Aim high. Assuming security and privacy challenges can be addressed, such a database could be a public health game changer.
From our Nation’s capital, the New York Times reports,
White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.
Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.
Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out
Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.
The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look.
From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”
From the maternal health front, the American Hospital Association informs us
The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.
From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.
Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.
From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.
From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.
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.
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.
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.
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.
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.
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.
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.
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.
The Senate and the House of Representatives are holding a State / District work period this week. Insurance News Net adds that the House Oversight and Reform Committee has “requested information regarding insurers’ and PBMs’ compliance with the ACA and CMS guidance [on contraceptive coverage] by June 8, 2022.
Pfizer’s antiviral drug, called Paxlovid, totaled more than 412,000 prescriptions through May 6, compared with about 110,000 prescriptions of molnupiravir, an antiviral from Merck & Co. and Ridgeback Biotherapeutics LP [called Lagevrio], according to drug-data firm Iqvia Holdings Inc. * * *
“Now that Paxlovid has become much easier to obtain, by and large relative to where it was before, Paxlovid is mine and the majority of my colleagues’ first choice,” said Ali Khan, chief medical officer of value-based strategy at Oak Street Health Inc., which has more than 140 primary-care clinics in 20 states across the U.S. * * *
“Doctors have become more comfortable with Paxlovid and more regularly prescribing the more effective drug,” said Zenobia Brown, medical director of health solutions at Northwell Health, a major New York healthcare provider.
Paxlovid, like Lagevrio, has been shown through lab studies to remain effective against Omicron and its subvariants. That has allowed doctors to prescribe it and reserve antibody treatments for other people who can’t take Paxlovid because of the potentially harmful drug interactions.
The White House earlier this month announced that households can now order a third round of free COVID-19 rapid tests on COVIDTest.gov.
Households can now receive eight new tests, double what households could order in the previous two rounds. USPS has delivered at least 380 million free tests through the program so far.
Bravo, USPS.
From the unusual viruses front —
STAT News updates us on monkeypox. “The ongoing monkeypox outbreak currently poses a moderate risk to global public health, the World Health Organization said Sunday in a statement that nevertheless raised the specter of the virus becoming entrenched as a pathogen that spreads from person to person. * * * To date most of the [257 confirmed] cases have been diagnosed in Europe and North America. The United States had detected 12 cases as of Friday. “Currently, the overall public health risk at [a] global level is assessed as moderate considering this is the first time that monkeyp ox cases and clusters are reported concurrently in widely disparate WHO geographical areas,” the global health agency said.”
The World Health Organization updates us on “Six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children [that] have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The majority of reported cases (n=374; 58%) are from the WHO European Region (22 countries), with 222 (34%) cases from the United Kingdom of Great Britiain and Northern Ireland alone. Probable cases and cases pending classification have also been reported from the Region of the Americas (n=240, including 216 cases in the United States of America) * * *.
From the miscellany department
The American Medical Association offers an article about what doctors wish their patients knew about living with migraines.
MedPage Today informs us “Using artificial intelligence (AI) during screening colonoscopy could be a cost-savings strategy that also could boost the prevention of colorectal cancer (CRC) incidence and mortality, a researcher reported.”
MedPage also tells us “Physical therapy-based rehabilitation frequently leads to better outcomes using fewer resources for patients with MSK pain when compared to operative procedures. But physical therapy must be a part of the treatment conversation early on, while surgery should be positioned as a last resort with the patient made well aware of surgery’s risks and complications. This is currently not the case in many patient-provider interactions.”
Based on the CDC’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 21st week of 2022:
Reliable estimates of case counts are particularly relevant with the U.S. in the midst of yet another Covid-19 wave. By official case counts, it is a modest wave, at roughly 110,000 infections a day, according to the CDC. That is smaller than the 165,000 daily cases reported during the Delta wave, or the 250,000 a day during the 2020-21 winter.
But estimates of the true number of infections, correcting for undercounting, suggest the U.S. might be experiencing the second-largest wave of Covid-19 infections since the pandemic began.
Here’s the CDC’s weekly chart of new Covid hospitalizations.
Hospitalization numbers also aren’t a perfect gauge. Someone can break a leg and test positive in the emergency room for a mild case of Covid-19. That case becomes a confirmed coronavirus hospitalization—and a strain on the hospital’s bed counts and personal-protective-equipment supplies—but not necessarily a severe case.
In Massachusetts, hospitals have begun reporting whether Covid-19 is the primary reason someone is in the hospital—and in January about 50% of cases were. It is hard to pinpoint how similar Massachusetts would be to other states, but it offers a further example of how better counting could improve assessment of the pandemic.
Here’s the FEHBlog weekly chart of new Covid deaths again from the 27th week of 2021 through the 21st week of 2022:
Covid-19 deaths in the U.S. are hovering near the lowest levels since the pandemic hit, showing how a population with built-up immune protection is less at risk of severe outcomes even as another wave of infections flows through the country.
The nearly 300 deaths reported daily are again more concentrated among older people, underscoring hazards for the more vulnerable while the overall population appears less at risk.
Particularly vulnerable people, such as those who are older and immunocompromised, will likely always have some risk of death from a Covid-19 infection, doctors and public-health experts said. Increasing booster rates and access to treatments, in addition to taking certain precautions, can help lower the threat presented by the virus, they said.
White House officials said on Thursday that they were introducing new models for distributing Paxlovid, the Covid-19 oral medication made by Pfizer, in an effort to get the treatment to more people and keep coronavirus death rates relatively low even as cases increase.
The federal government will start reimbursing a clinic in Providence, R.I., for evaluating patients who test positive and immediately prescribing Paxlovid to those eligible for it — the first of what the White House said would be a series of federally supported sites, with others set to open in New York and Illinois. Federal workers are also being sent to state-run testing sites in Minnesota, transforming them into “test-to-treat” locations, the White House said.
“Fundamentally, what we’re trying to do is get to a point where Covid deaths are largely preventable, and I think we’re pretty close to there,” Dr. Ashish K. Jha, the White House Covid-19 response coordinator, said in an interview Wednesday evening. “Deaths from this disease really should become increasingly rare.”
STAT News offers an interesting look into how scientists assess the level of Covid resistance to Paxlovid.
Resistance is the hobgoblin of antiviral medicine, even with antivirals as effective as Paxlovid. After doctors deployed nearly every new virus-killing infusion or pill in history, strains popped up — either immediately or eventually — with machinery warped in just the right way to evade the threat.
Exactly how much of a problem resistance will be for Paxlovid is complicated. In some patients, the coronavirus will inevitably find ways to evade the pill, as it did prior Covid-19 drugs.
“If there is anything we know about viruses and antiviral drugs is that eventually we will see some sort of resistance,” Andrew Pavia, chief of pediatric infectious diseases at University of Utah Health, said in an email.
What’s less clear, Pavia and other experts say, is whether any resistant variants will spread widely. The coronavirus may have particular difficulty getting around Paxlovid compared to other drugs because patients take it for only five days and because it targets a protein the virus can’t easily change. Any mutation or modification the virus makes may impair its ability to replicate or survive.
Here’s the FEHBlog weekly chart of Covid vaccinations distributed and administered
The CDC’s weekly review of its Covid statistic tells us
People who are up to date on vaccines have much lower risk of serious illness and death from COVID-19 compared with people who are unvaccinated. CDC’s COVID Data Tracker shows that in March 2022, adults ages 18 years and older who were unvaccinated were about 5 times more likely to be hospitalized with COVID-19 than those who were up to date. In the same month, people ages 12 years and older and unvaccinated were 17 timesmore likely to die of COVID-19 than those who were up to date.
COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and even dying—especially people who are boosted. As with other diseases, you are protected best from COVID-19 when you stay up to date with recommended vaccines. Find a vaccine provider near you.
As of May 19, 2022, there are 301 (9.35%) counties, districts, or territories with a high COVID-19 Community Level, 477 (14.81%) counties with a medium Community Level, and 2,442 (75.84%) counties with a low Community Level. This represents a moderate (+5.10 percentage points) increase in the number of high-level counties, a slight (−0.74 percentage points) decrease in the number of medium-level counties, and a corresponding (−5.84 percentage points) decrease in the number of low-level counties. Five (9.62%) of 52 jurisdictions had no high- or medium-level counties this week.
the Centers for Medicare & Medicaid Services (CMS) released a report that recommends cost savings from lower-than-expected Medicare Part B spending be passed along to people with Medicare Part B coverage in the calculation of the 2023 Part B premium. Earlier this year, Department of Health and Human Services (HHS) Secretary Xavier Becerra instructed CMS to reassess the 2022 Part B premium amount in response to a price reduction for Aduhelm™, a monoclonal antibody directed against amyloid for use in treating Alzheimer’s disease. Given the information available today, it is expected that the 2023 premium will be lower than 2022. The final determination will be made later this fall.
This CMS decision is quite sensible, in the FEHBlog’s view.
On a related FEHB note, FedSmith discusses the pros and cons of enrolling in Medicare Part B when you are a federal or Postal annuitant with FEHB coverage in retirement as well.
From the telehealth front, mHealth Intelligence reports
Called CVS Health Virtual Primary Care, the digital care platform will provide healthcare consumers with an array of care services, including primary care, on-demand care, chronic condition management, and mental health services. Consumers will also be able to choose their healthcare setting from various retail, community-based, virtual, and at-home care options.
“We’re meeting people where they are on their healthcare journey and providing care that is more convenient and easier to access,” said Creagh Milford, DO, vice president, enterprise virtual care at CVS Health, in the news release.
The new benefit will launch on January 1, 2023.
From the Rx coverage front, Formulary Watch reveals that
The Institute for Clinical and Economic Review (ICER) has released the protocol for its second annual review of insurance company policies to assess fair access to prescription drugs. ICER will evaluate whether 15 large U.S. commercial payers, the two largest state health exchange plans, and the Department of Veterans Affairs have formularies and procedures that provide appropriate access to the prescription drugs reviewed by ICER in 2020. These drugs include those that treat patients with cystic fibrosis, hemophilia A, migraine, sickle cell disease, and ulcerative colitis.
The analysis is expected to be completed in November 2022.
From the studies front, the Centers for Disease Control issued its 2021 Diabetes Report Card this week. Here are the highlights
* After almost 2 decades of continual increases, the incidence of newly diagnosed cases of diabetes in the United States decreased from 9.3 per 1,000 adults in 2009 to 5.9 per 1,000 adults in 2019.
* Prevalence of prediabetes among US adults remained steady from 2005–2008 to 2017–2020. However, notification of prediabetes status nearly tripled (from 6.5% to 17.4%).
* American Indian or Alaska Native, non-Hispanic Black, Hispanic, and non-Hispanic Asian people are more likely to be diagnosed with diabetes than non-Hispanic White people (14.5%, 12.1%, 11.8%, 9.5%, and 7.4%, respectively).
* During the COVID-19 pandemic, diabetes emerged as an underlying condition that increases the chance of severe illness. Nearly 4 in 10 adults who died from COVID-19 in the United States also had diabetes.
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.
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.”
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.
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 tosix 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.
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.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
