According to the CDC’s Weekly Interpretative Report on its Covid Data Tracker, Omicron cases, hospitalizations, and deaths continued to trend down last week while community-level statistics improved. The CDC report leads with an analysis of Omicron variants. Only 4% of U.S. counties have a high level of Covid infections based on the CDC’s Communities approach.
The CDC’s weekly Fluview continues its string of reports that “Seasonal influenza activity continues to decline across the country.”
“The CDC warned of a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa linked to various brands of artificial tear drops.
“An investigation identified artificial tears as a common exposure for many patients. Patients reported using over 10 different brands of artificial tears; EzriCare Artificial Tears, an over-the-counter product, was most common.
“Pending additional guidance from the CDC and FDA, “patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears,” the CDC said in an advisory to its Health Alert Network.”
From the health plan design front, the FEHBlog has run across helpful articles from the Kaiser Family Foundation, the Advisory Board, and Forbes on the impact of the May 11, 2023, end of the Covid national and public health emergency. From a health plan standpoint, the biggest considerations are the end of (a) out-of-network testing and vaccine mandates and (b) the mandate to provide free rapid covid tests. Sometime in 2023, the federal government’s funding for Covid vaccines and Paxlovid will be exhausted, and health plans will need to pick up the slack.
The Office of Personnel Management’s own Federal Employee Benefits Surveys, cumulatively covering hundreds of thousands of feds, have consistently reinforced this point—showing around 80% or more of feds identify strong benefits programs (led by federal retirement annuities, the Thrift Savings Plan and Federal Employees Health Benefits insurance programs) as a major part of why they stick with their jobs.
The Employee Benefit Research Institute recently published a new report exploring such issues—one zeroing in on what makes a job “sticky” for employees, covering data and anecdotal evidence on private- and public-sector employment over the last 40 years.
Craig Copeland, EBRI’s director of Wealth Benefits Research parsed these findings for Government Executive and affirmed that attractive federal benefits remain crucial in helping agencies retain feds.
“Yes, it is still clear that public sector employees—including feds—are more likely to stay at their job longer than other sectors, at least up until recent years,” Copeland told Government Executive. “The defined benefits plans that public sector jobs usually provide typically are an important part of the reason that public sector employees stay longer—as well as because of the overall typically better benefits offered to public sector employees when compared with the average private sector employee.”
However, Copeland said that it’s hard to say if these long-term trends—the popularity of strong benefits and the stickiness of the public-sector jobs that offer them—persist among the growing younger slice of feds.
The American Health Association (AHA) went bananas over the Justice Department’s unexpected withdrawal of aging antitrust guidance that favors the healthcare industry. Fierce Healthcare also discusses DOJ’s action
Also, from the AHA
Alabama hospitals lost $1.5 billion since the beginning of the pandemic, despite receiving federal COVID-19 relief funds. At the same time, costs increased $2.6 billion, leaving over half of the state’s hospitals currently operating in the red, Kaufman Hall reports.
Indiana hospitals have lost $1.2 billion since 2019, with expenses for labor, medical supplies, drugs and other purchased services up by $3.2 billion, leaving many of the state’s hospitals with negative operating margins, according to a Kaufman Hall analysis.
The American Hospital Association’s 2023 legislative strategy is unveiled in a Politico article.
President Biden and House Speaker Kevin McCarthy began face-to-face debt-ceiling discussions [today], with the latter expressing cautious optimism that they can come to a deal to avoid the first-ever default of the country’s debt.
Senate Minority Leader Mitch McConnell (R-Ky.) has pulled Sen. Rick Scott (R-Fla.), who tried to oust him as the Senate’s top Republican in a bruising leadership race, off the powerful Commerce Committee.
McConnell also removed Sen. Mike Lee (R-Utah), who supported Scott’s bid to replace McConnell as leader, from the Commerce panel, which has broad jurisdiction over a swath of federal agencies.
Speaking of federal agencies, Healthcare Dive informs us
The Federal Trade Commission is penalizing GoodRx for sharing users’ sensitive health information with advertisers, in the agency’s first enforcement action under the Health Breach Notification Rule.
The FTC filed an order with the Department of Justice on Wednesday that would prohibit GoodRx from sharing user health data with third parties for advertising purposes, among other guardrails. GoodRx has also agreed to pay a $1.5 million fine, though the company admitted no wrongdoing. The order needs to be approved by a federal court in order to go into effect.
Also, the President issued a Statement of Administration Policy objecting to Republican legislative efforts to end the national and public health emergencies for the Covid pandemic without further delay. The Statement explains why the White House has opted to end those emergencies on May 11.
CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.
“Today, CMS is announcing a Marketplace Special Enrollment Period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of the continuous enrollment condition, also known as ‘unwinding,’” the FAQ sheet explained.
The special enrollment period will stretch from March 31, 2023 to July 31, 2024. In order to be eligible for the special enrollment period, individuals must be eligible for Affordable Care Act marketplace coverage and must have lost their Medicaid, Children’s Health Insurance Program (CHIP), or Basic Health Program (BHP) coverage.
From the Omicron and siblings front, Beckers Hospital Review points out
The FDA altered its emergency use authorizations on Paxlovid and Lagevrio, two COVID-19 treatments, on Feb. 1 to revoke a requirement for a positive COVID-19 test before a provider can prescribe them.
“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in an emailed statement. But, “in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19” even if they test negative.
From the public health front —
The Commonwealth Fund issued a report titled “U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes.” The FEHBlog’s perception is quite sunny compared to this gloomy report.
The National Institutes of Health is celebrating American Heart Month.
The National Cancer Institute offers an interesting newsletter on its work.
The Wall Street considers dangerous fungi that are infecting people as a result of climate change.
From the No Surprises Act front, according to Healthcare Dive, the Texas Medical Association has filed a fourth lawsuit concerning the law. This time the TMA objects to the regulators’ entirely appropriate decision to increase the arbitration administration fee from $100 split between the parties to $700 similarly split. The arbitration or IDRE process was being bombarded with arbitration requests from providers. The fee increase will focus more provider attention on the open negotiation period that precedes the arbitration. “The suit also challenges the laws’ restrictions on batching claims, which allows arbitration processes only on claims with the same service code, requiring providers to go through a separate payment dispute process for each claim related to an individual’s care episode, according to the suit.” Quelle domage.
From the U.S. healthcare business front
Beckers Payer Issues reports, “Humana posted revenues of nearly $93 billion in 2022 and a net loss of $15 million in the most recent quarter, according to its year-end earnings report published Feb. 1. The company also appointed Steward Health Care President Sanjay Shetty, MD, to lead its healthcare services business, CenterWell, which includes pharmacy dispensing, provider and home health services. Dr. Shetty will start April 1. In addition, the company promoted its Medicare president, George Renaudin, to president of Medicare and Medicaid, effective immediately.”
Beckers Hospital Review examines whether Amazon can disrupt the pharmacy industry.
From the Medicare front, the Centers for Medicare and Medicaid Services released
the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through Friday, March 3, 2023. CMS will carefully consider timely comments received before publishing the final Rate Announcement by April 3, 2023.
House Republicans are mulling an attempt to buy time for further negotiations on federal spending and deficits by passing one or more short-term suspensions of the statutory debt ceiling this summer, including potentially lining up the deadline with the end of the fiscal year Sept. 30.
No decisions on a cutoff date have been made, and it’s not yet clear when the Treasury Department will run out of cash to meet all U.S. financial obligations. But most analysts agree Congress will need to act at some point between early June and September, and lawmakers likely won’t want to leave the matter unaddressed before the August recess.
and
The Senate is taking its time getting to work for 2023.
Back in Washington after a two-and-a-half week recess, the chamber adjourned Thursday afternoon without adopting an organizing resolution, meaning committees will remain in their holdover state until at least next week.
Senate Majority Leader Charles E. Schumer announced the Democratic committee assignments for the new Congress, with Michigan Democratic Sen. Gary Peters, the Democratic Senatorial Campaign Committee chair, earning a coveted seat on the Appropriations Committee.
From the Omicron and sibligns front, The American Hospital Association tells us
A Food and Drug Administration Vaccines and Related Biological Products Advisory Committee [VRBAC] unanimously voted today to recommend harmonizing the composition of all primary series and booster doses administered in the U.S. For example, the composition of all vaccines administered going forward might be bivalent.
STAT News offers a complete report on today’s meeting. For example, STAT News explains
The FDA is also asking the members of VRBPAC their thoughts on its proposal that Americans get an annual Covid shot, in the way they get a flu shot, one that is reconstituted regularly to try to target the strains in circulation at the time. In documents the FDA made public before the meeting, it proposed choosing new vaccine strains in June for a vaccine campaign that would begin in September.
Covid is clearly here to stay, so this may sound sensible. But there are concerns some of this is still based on a leap of faith rather than a data-led process. For example, the idea that everyone might need an annual Covid booster will not earn a unanimous “yea” vote out of this expert panel.
The VRBAC recommendation is subject to FDA and CDC approval.
The FDA on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.
In other FDA news
The FDA announced, “Given the growing cannabidiol (CBD) products market, the FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
Fierce BioTech informs us “More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.”
From the obesity treatment front —
HealthDay discusses findings made by “Utah researchers who followed patients for up to 40 years after they had one of four types of weight-loss (bariatric) surgery.”
Weight-loss surgery can literally be a lifesaver, cutting death rates significantly during the course of a decades-long study
Death from all causes was 16% lower, while it was 29% lower for heart disease, 43% lower for cancer and 72% lower for diabetes
But there were some troubling findings: These patients were 83% more likely to die of liver disease and 2.4 times more likely to die by suicide, mostly seen in younger patients
STAT News provides a two minute long video explaining how the new obesity drugs work.
STAT News also describes an unusual alliance that has banded together to lobby Congress to repeal a provision in the Medicare Modernization Act of 2023 that prohibits Part D from covering obesity drugs. “Recent scientific advances, media coverage, and advocacy have helped raise the profile of the issue on Capitol Hill, said Jeanne Blankenship, the vice president for policy initiatives and advocacy at the Academy of Nutrition and Dietetics. ‘It’s becoming front and center. I think we can’t turn our backs on it any longer,’ Blankenship said.”
From the Rx coverage front, Beckers Hospital Review introduces us to the three PBMs that have partnered with the Mark Cuban Pharmacy.
From the HIPAA / electronic health records front —
MedPage Today reports, “Unique Patient Identifier Funding Once Again Barred by Congress— Biden administration working on better patient matching instead.” The FEHBlog will never understand Congress’s intransigence here.
Healthcare Dive tell us “Interoperability continues to improve among U.S. hospitals, but there’s still a ways to go, according to new government data. More than six in 10 hospitals electronically shared health information and integrated it into their electronic health records in 2021, up 51% since 2017, the Office of the National Coordinator released in a Thursday data brief. The availability and usage of electronic data received from outside sources at the point of care has also increased over the last four years, reaching 62% and 71% respectively in 2021.”
Mercer Consulting “projects the 2024 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will rise significantly from 2023 levels.”
Benefits Consultant Tammy Flanagan, writing in Govexec, discusses the categories of family members who are eligible and ineligible for FEHB coverage.
HR Dive identifies five trends that will share HR this year.
OPM Headquarters a/k/a the Theodore Roosevelt Building
The FEHBlog was delighted to read today that OPM is encouraging FEHB carriers that OPM is encouraging FEHB carriers to incorporate Medicare Part D EGWPs in their plans for 2024. The FEHBlog has been encouraging this step for years, as readers must know.
The Medicare Part D EGWPs will cushion the FEHBP against the expenses of drugs to treat Alzheimer’s Disease and other illnesses that impact annuitants over age 65. While there are many factors at play in determining premiums, this factor standing alone would lower premiums. Thank you, OPM.
From the Omicron and siblings front, the New York Times virus briefing newsletter wished its readers well today.
Now, after three years, we’re pausing this newsletter. The acute phase of the pandemic has faded in much of the world, and many of us have tried to pick up the pieces and move on. We promise to return to your inbox if the pandemic takes a sharp turn. But, for now, this is goodbye.
In a study released today by the Centers for Disease Control and Prevention [CDC}, a single bivalent COVID-19 vaccine booster provided additional protection against omicron XBB variants in adults who previously received two to four monovalent vaccine doses. XBB-related variants account for over half of currently circulating COVID-19 variants in the United States.
“All persons should stay up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when eligible,” the authors conclude.
and
The CDC yesterday launched a website to help consumers locate no-cost COVID-19 testing through its Increasing Community Access to Testing program, which includes pharmacies, commercial laboratories and other sites that bill the tests to government and private insurers and focus on vulnerable communities. The tests may include laboratory-based nucleic acid amplification tests and rapid antigen point-of-care tests, with results typically provided in 24-48 hours.
From the public health front
The Hill tells us about a CDC internal reorganization.
The HHS Agency for Healthcare Quality and Research provides us with an infographic and report about the three most commonly treated illnesses among older adults — hypertension, hyperlipidemia, and arthritis / other joint disorders
Fierce Healthcare relates, “The Biden administration is planning to release three to four new payment models on advance primary care and another enabling states to assume the total cost of care for Medicare, a top official shared.”
HHS’s HEAL Program Director, Dr. Rebecca Baker, discusses “Research That Offers Hope to End Addiction Long-Term.”
From the U.S. healthcare business front
Healthcare Dive reports
Elevance Health, one of the nation’s largest insurers, added more members in 2022, fueled by growth in its government business thanks to continued relaxed eligibility rules on enrollment.
Elevance ended the year covering 47.5 million people, a nearly 5% increase from the prior-year period, driven largely by growth in Medicaid members.
In turn, total revenue climbed 13% to nearly $157 billion for the year as the insurer collected higher premium revenue from its Medicaid plans.
Net income dipped about 1% to $6 billion for the full year as expenses climbed about 14%.
Over 1.8 million more people enrolled in marketplace coverage compared to last year — a 13% increase, and the most amount of plan selections of any year since the launch of the ACA marketplace a decade ago, according to the CMS. The record-breaking enrollment numbers include 3.6 million first-time marketplace enrollees.
The claims have become almost ubiquitous. Hospital CEO after hospital CEO stands at a podium and promises the merger being announced will improve quality and lower costs.
Once deals close, though, there tends to be little, if any, follow-up to determine whether those things actually happened. A new Journal of the American Medical Association study adds to the growing body of evidence that they don’t. The authors looked across a large swath of the country’s hospitals and physicians found that while quality did improve marginally, the prices paid for services delivered by health system hospitals and doctors was significantly higher than their non-system peers.
“You start to feel really hopeful when you hear about this, ‘Yeah, we can really improve health care,’ and then when you look at it, it’s just not there,” said Nancy Beaulieu, a study author and research associate in Harvard Medical School’s department of health care policy.
A top insurance lobbying group plans to press Congress this session to adopt legislation that expands the footprint of site-neutral payment reform, setting up a likely clash with hospital groups.
The Blue Cross Blue Shield Association (BCBSA), which represents 38 Blues plans, released several policy priorities for the current Congress as part of a new report Tuesday. Some of the policies focus on changing Medicare reimbursement rates to pay the same amount to clinics whether they are independent or affiliated with a hospital. Other reforms focus on prescription drugs and spurring more participation in value-based care.
“We’re very concerned about the increasing acquisition of physician practices by hospitals in the healthcare system,” said Kris Haltmeyer, vice president of policy analysis for BCBSA, during a reporter briefing Tuesday.
One of the association’s major priorities is to pass a bill that would remove a grandfathering provision in the 2015 Balanced Budget Act. The provision shielded certain hospital outpatient departments from billing limits established in the law, with the exception of emergency departments.
The association also wants to require off-campus hospital sites to get a different national provider identifier than the main facility campus. They should also use a different claim form for any professional service rendered in an office or clinic owned by a hospital but not on the campus.
The weekly rate of emergency department visits and hospitalizations for flu, COVID-19 and respiratory syncytial virus peaked in early December, new CDC data shows.
ED visits for flu, RSV and COVID-19 peaked the week ending Dec. 3, hitting a weekly total of 235,850 before falling through December and the first half of January. The nation’s current weekly total was 72,119 as of Jan. 14, according to the ED dashboard. The dashboard uses information from the CDC’s National Syndromic Surveillance Program, which receives data from 73 percent of the nation’s EDs.
The combined hospitalization rate for flu, RSV and COVID-19 peaked at 22.5 admissions per 100,000 in the week ending Dec. 3. This figure now sits at 9.4 per 100,000 for the week ending Jan. 7, though the CDC said reporting delays may affect the most recent week’s data.
RSV hospitalizations peaked in mid-November, while flu hospitalizations peaked in early December, CDC data shows. COVID-19 admissions also appear to be leveling off nationwide, even as the highly transmissible omicron subvariant XBB.1.5 gains prevalence. This trend suggests the U.S. will see more of a COVID-19 “bump” this winter versus a full-fledged surge, experts told The New York Times.
The CDC’s weekly interpretative review of its Covid stats focuses on these new dashboards this week. The agency’s weekly Fluview report informs us “Seasonal influenza activity continues to decline across the country.”
A recent climb in hospitalizations and Covid-19 wastewater readings—two key metrics for spotting trends—appears to have stalled following the quick rise of the Omicron XBB.1.5 subvariant. The U.S. was gripped in significantly more deadly waves at this point in the last two winters, though currently there are still hundreds of deaths reported each day. * * *
At least for now, it appears unlikely new variants are going to cause as substantial illnesses and deaths as the virus did early on and in the prior winter waves, said Jay Varma, a physician and epidemiologist who directs Weill Cornell Medicine’s Center for Pandemic Prevention and Response in New York City. He cautioned that more severe mutations could still emerge. “We seem to have settled into somewhat of a detente with the virus,” he said.
Although the FEHBlog will continue to track Omicron and siblings developments, he has decided to replace Friday Stats and More with Friday Factoids.
Public health officials have said for some time that use of Paxlovid, approved under an FDA emergency use authorization (EUA) in December 2021, remains far below the proportion of Americans who could potentially benefit from the therapy.
What’s driving the lackluster uptake remains unknown, so Medscape Medical News took a deeper dive into the challenges surrounding Paxlovid prescribing.
Older Americans remain one of the groups at highest risk for COVID-19 adverse outcomes, including hospitalization and severe illness. However, the survey found that providers also remain reluctant to prescribe Paxlovid in this population for multiple reasons. * * *
The survey found that almost half of patients were on a medication that is contraindicated with Paxlovid and that could not be discontinued (44%). Another finding was that almost the same proportion were on a medication that is contraindicated with Paxlovid, but the risk of discontinuing that medication was too high (41%). Also, the researchers found some patients were on a medication that could interact with Paxlovid, but it was unclear how to manage the interaction (29%).
[Medscape medical editor in chief Dr. Eric Topol said that doctors, in some cases, may be overly concerned about the drug interactions. “There’s a straightforward workaround strategy for nearly all the drug interactions — most commonly statins — which can easily be stopped for 5 days,” he said.
Another concern preventing Paxlovid prescription is renal impairment, the survey reveals. More than one third of respondents, 37%, said they did not prescribe the protease inhibitor combination because of concerns over this condition, which can lower how efficiently medications are cleared by the body.
Fewer emergency department (ED) visits end with a prescription for opioids, CDC survey data showed.
The percentage of ED visits with an opioid prescribed at discharge fell from 12.2% in 2017-2018 to 8.1% in 2019-2020, reported Loredana Santo, MD, MPH, and Susan Schappert, MA, of the National Center for Health Statistics in Hyattsville, Maryland, in NCHS Data Briefopens in a new tab or window.
The rate of prescribing at discharge also dropped: in 2019-2020, opioids were prescribed at 36.4 ED visits per 1,000 adults, lower than 50.5 per 1,000 in 2017-2018. The decline was similar for both men and women.
In U.S. healthcare business news —
Cigna points out the value of integrated health plans a/k/a health plans without carveouts.
A study released today by Cigna (NYSE: CI), a global health service company, finds that triple integration of medical, pharmacy and behavioral benefits resulted in lower health care costs for employers. Conducted by Aon plcThis link will open in a new tab., a leading global professional services firm, the Value of Integration StudyThis link will open in a new tab. [PDF] shows that Cigna’s integrated employer clients saved $148 per member per year in 2021.
Using a similar study method, Cigna then evaluated the financial impact of engaging employees to participate in health improvement programs, such as wellness coaching. The results show even greater client savings for Cigna integrated employer clients, exceeding $1,400 per member per year.
In addition, Cigna found that when individuals with specific high-cost conditions and therapies were enrolled in a triple-integrated health plan and needed specialty medicines, the savings for the health plan were:
Nearly $9,000 per member per year, increasing to more than $11,000 per member when the specialty drug is for an inflammatory condition like rheumatoid arthritis; and
Almost $17,500 per year for members who took specialty drugs and have a confirmed depression diagnosis.
Medpage Today reports, “Switching to [employer-sponsored] high-deductible health plans (HDHPs) spelled trouble when it came to diabetes complications, a retrospective cohort study found.” The report studies health savings account (HSA) – eligible HDHPs versus traditional low-deductible plans. The FEHBlog doesn’t understand why the HSAs don’t balance out the two types of coverage. The article doesn’t compute.
STAT News relates, “More than a dozen of the country’s large not-for-profit hospital systems descended on this year’s J.P. Morgan Healthcare Conference with a subtle but clear message for bankers and municipal investors: Higher costs in 2022 slowed them down, but they are adamant about increasing revenue by expanding their footprints and hiking prices.” Charming.
A new behavioral health solution launched this week aims to make it easier for insurers to connect members with tools that may benefit their mental health care.
Lucet represents the combination of New Directions Behavioral Health and Tridiuum and is a spinout from the Blues network, where its core product cut its teeth. Lucet’s Navigate & Connect platform harnesses a large team of care navigators with an advanced technology stack that allows insurers to better optimize care and access for members.
Shana Hoffman, president and CEO of Lucet, told Fierce Healthcare that the platform enables faster connections to appointments and helps cut through the noise on which solutions a plan may want to bring into the fold.
“What we’re bringing to the market is really an operating system platform for health plans that allows them to reliably connect members to care,” Hoffman said.
Health Affairs Forefront analyzes “The Fair Price For One-Time Treatments; How Can We Overcome Existing Market Price Distortions?” Check it out.
From Capitol Hill, Roll Call reports that Senator Joe Manchin (D W Va) “has talked “briefly” with Speaker Kevin McCarthy about a bill he co-sponsored with Sen. Mitt Romney, R-Utah, in the last Congress to create a “rescue committee” for every endangered government trust fund, like the Social Security, Medicare and highway trust funds.
The Concord Coalition, a nonpartisan research group, named Romney and Manchin as its 2022 Economic Patriot Awards honorees because of their work on the legislation.
The bill, which they have yet to reintroduce in the 118th Congress, would allow the top four congressional leaders to appoint three members each for every rescue committee and give lawmakers on the panels 180 days to come up with policy solutions for solvency.
Any legislation the rescue committees produce would be subject to expedited procedures for floor consideration; it couldn’t be amended but would require 60 Senate votes to advance to final passage.
Moderna Inc. plans to expand its mRNA vaccine production capacity, saying shots targeting different pathogens can be made in the same facility, Chief Executive Stephane Bancel said.
“This is what gives me hope, not only for [coronavirus] variants, but also for other vaccines,” Mr. Bancel said on a panel at the World Economic Forum in Davos, Switzerland. * * *
The company was able to roll out booster shots adapted to the Omicron variant in 60 days, according to Mr. Bancel.
That would be helpful assuming the FDA and CDC are on board.
The Centers for Disease Control and Prevention yesterday released a dashboard tracking hospitalization rates for laboratory-confirmed COVID-19, flu and Respiratory Syncytial Virus by age group, sex, race/ethnicity, state and season based on data from select counties in 13 states, which the agency will update weekly. CDC also released another dashboard tracking weekly emergency department visits for COVID-19, flu and RSV by age group and percent of all ED visits based on data from the National Syndromic Surveillance Program.
In other vaccine news, the National Institutes of Health announced today
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America. Based on the DSMB’s recommendation, the study will be discontinued. Participants are being notified of the findings, and further analyses of the study data are planned.
Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, sponsored the Mosaico study with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.
Keep trying.
Also from the public health front
Gallup informs us “The percentage of Americans reporting they or a family member postponed medical treatment in 2022 due to cost rose 12 points in one year, to 38%, the highest in Gallup’s 22-year trend.” The story concludes
With high inflation creating moderate to severe hardship for a majority of Americans in the second half of 2022, their reports of delaying medical care in general due to cost — as well as delaying care for a serious condition — rose sharply to new highs. Young adults, those in lower-income households and women were especially likely to say they or a family member had put off medical care.
No bueno.
From the U.S. healthcare business front, McKinsey & Co. tells us
From the Medicare front, Fierce Healthcare relates
Enrollment in Medicare Advantage (MA) has topped 30 million, according to new data from the Centers for Medicare & Medicaid Services.
This represents coverage across 776 contracts, according to the data, as of Jan. 1 payments, which reflect enrollments accepted through Dec. 2. Enrollment in standalone prescription drug plans was also about 22.7 million, bringing total enrollment across all types of private Medicare plans to nearly 50.3 million.
This represents growth of about 2 million from 2022. An analysis from the Kaiser Family Foundation found that enrollment in MA plans was about 28 million last year.
Because there is no CDC interpretative summary of Covid stats on a holiday weekend, here is a link to the CDC’s Covid data tracker, which updates on Thursday. The FEHBlog sees more of the same which would be expected when a disease reaches the endemic phase.
In other Omicron news
MedPage Today reports, “An early signal of stroke risk was detected in older adults who received Pfizer-BioNTech’s bivalent COVID-19 vaccine, the FDA and CDC announced in a joint statement late on Friday, yet the agencies found no link in further analyses and are not recommending a change in COVID-19 vaccination practice.” Agency experts will discuss this data “an already-scheduled January 26 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee.”
Because the FEHBlog is in that Pfizer cohort, he will keep an eye on this meeting. Attending the meeting is Dr. Paul Offit who explains in Medscape his expert opinion that the bivalent booster’s administration should be limited to older and immunocompromised people. It’s an interesting read for a concerned layperson.
WebMD tells us, “The evidence is piling up that physical activity can lower the risk of getting very sick from COVID. The CDC, based on a systematic review of the evidence, has reported that “physical activity is associated with a decrease in COVID-19 hospitalizations and deaths, while inactivity increases that risk.” Other research has linked regular physical activity with a lower risk of infection, hospitalization, and death from COVID. The latest such study from Kaiser Permanente suggests that exercise in almost any amount [e.g., a 10-minute weekly walk] can cut the risk of severe or fatal COVID even among high-risk patients like those with hypertension or cardiovascular disease.
Here’s the CDC’s Fluview ,which is updated for today. “Seasonal influenza activity continues but is declining in most areas.” Good news.
In OPM News
The Chair and Ranking Member of the Senate Committee that oversees OPM who requested this week’s report GAO report on family member eligibility are not happy with its conclusions.
Federal News Network reports on OPM’s long-term efforts to advance diversity, equity, inclusion and accessibility for the federal workforce.
In other agency news
Politico discusses efforts to help the CDC reform itself.
STAT News reports, “The Democrats leading the Federal Trade Commission are hoping to expand the agency’s authority to crack down on unfair business practices — and the shift could have major implications for its ongoing scrutiny of pharmacy benefit managers.”
HR Dive notes that the EEOC’s “draft Strategic Enforcement Plan (SEP) for 2023-2027 appeared in the Federal Register and stakeholders may comment through Feb. 9.”
Govexec reports, “The federal government is expecting to run up against its borrowing limit as soon as June, Treasury Department Secretary Janet Yellen told Congress on Friday, kicking off a legislative fight that could result in significant disruptions to government operations and the U.S. economy.”
In U.S. healthcare business news, Healthcare Dive informs us
Healthcare giant UnitedHealth Group beat analyst expectations for the fourth quarter of 2022 with revenue of $82.8 billion, up more than 12% year over year, according to results released premarket Friday.
Industry experts have expressed concern about potential recessionary pressures and upset care utilization patterns headed into 2023. But UnitedHealth’s earnings, which are considered a bellwether for the health insurance sector’s performance, may prove to be a positive sign for payers.
The Senate is on a State work break until January 23.
The House of Representatives will be in session this week for floor business. The Wall Street Journal adds
The House will dive into its first week of substantive work with bills to cut Internal Revenue Service funding and investigate economic competition from China, after a leadership election that underscored Republican divides and the fragile position of Speaker Kevin McCarthy (R., Calif.). * * *
On Monday, the House will vote on a set of chamber rules for the 118th Congress that will enshrine some of the pledges regarding legislative procedure Mr. McCarthy made to win over holdouts in his speaker election. The rules package will also make key changes to the operations of the Office of Congressional Ethics, which conducts initial reviews of allegations of impropriety against lawmakers.
“We’ll pass the rules package tomorrow, and we’ll get moving on doing what the American people elected us to do,” said Rep. Jim Jordan (R., Ohio), the incoming Judiciary Committee chairman and a prominent McCarthy ally, in an interview Sunday on Fox News. “In a two-year time span, we have seen a border that is no longer a border. We have seen a military that can’t meet its recruitment goals. We’ve seen terrible energy policy, terrible education policy…We’re going to unite around fixing those problems.”
Democrats said they hoped to find areas of bipartisan agreement. “Clearly we are going to have strong disagreements at times, but we can agree to disagree without being disagreeable,” said House Minority Leader Hakeem Jeffries (D., N.Y.) on NBC on Sunday.
The Journal also provides greater insight into the availability of the new Alzheimer’s disease drug that the FDA approved last week.
A sweeping Medicare rule issued last year [following the Aduhlem fiasco] will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come.
The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab,for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned.
The Alzheimer’s Association patient-advocacy group asked the Centers for Medicare and Medicaid Services in December to reconsider its policy, a process that could take as long as six to nine months if it chooses to do so.
As many as 85% of patients who could benefit from Leqembi are insured by Medicare, said Ivan Cheung, Eisai’s global Alzheimer’s disease officer. Eisai projects that 100,000 patients could be using the drug by its third year on the market, assuming that Medicare officials lift coverage restrictions, Mr. Cheung said.
From the public health front, Forbes delves into Omicron XBB 1.5. As the FEHBlog noted last Friday new Covid cases and hospitalizations are up because winter has arrived. Forbes reminds us
From Dec. 21 to 27, 2022, 5,613 people were admitted with positive COVID tests, compared to 6,519 from Dec. 28 to Jan. 3. However this is still a far cry, down 69.7%, from the peak seven-day average in mid-January 2022 when 21,525 were admitted with COVID.
Last year’s Omicron alpha phase dwarfs the current surge which the FEHBlog attributes to the fact that Paxlovid did not reach the market until December 22, 2021.
Forbes also offers parents information about signs and symptoms of invasive strep cases currently afflicting children.
NPR Shots reports on the worthy efforts of various physicians to improve the care of miscarrying patients.
“Fewer abortions will mean more pregnancies, and more pregnancies will mean more miscarriages,” said Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Washington and a co-author of the guidelines on miscarriage management for the American College of Obstetricians and Gynecologists.
Around 15% of known pregnancies end in miscarriage, and the first medical professional many of those patients see will be in an emergency room. Yet, by and large, she says, “emergency medicine physicians aren’t trained in managing miscarriage and don’t see it as something they should own.”
For more than a decade, Prager has been trying to change that through her work with the TEAMM Project, the nonprofit she co-founded on the premise that “many people experience miscarriage before they’re established with an OB-GYN.” Short for Training, Education and Advocacy in Miscarriage Management, TEAMM has conducted in-person workshops for clinicians at more than 100 sites in 19 states on all aspects of miscarriage care — everything from the use of ultrasound to diagnose fetal death to the three treatment options miscarrying patients should be offered when they come in for care.
From the medical trial front, the Wall Street Journal points out a significant issue with cancer treatment trials.
After Mikhail Rubin learned his lethal blood disease had progressed, he decided that he wanted a stem-cell transplant through a clinical trial. But there was an obstacle: his age.
Mr. Rubin, who is now 72, was too old to participate. Many cancer trials cap enrollment at age 65. Even when trials for older people are available, oncologists are reluctant to enroll elderly patients because frailties might make them less resilient against side effects from toxic treatments, according to a 2020 study in an American Cancer Society journal. People over 70 represent a growing share of the cancer-patient population but are vastly underrepresentedin clinical trials, the study said.
“How can we make decisions for people over 70 if people over 70 are not included in the trials that we use to base our decision making?” said Dr. Mina Sedrak, deputy director of the Center for Cancer and Aging at City of Hope, a cancer center near Los Angeles and an author of the paper.
Fair question, Dr. Sendrak.
From the health plan consumer app front, Fierce Healthcare tells us
Elevance Health is making the latest expansion to its Sydney member app with the addition of a new Nutrition Tracker tool.
The tracker uses artificial intelligence to recognize foods in photographs taken by a member’s smartphone camera. It can log individual foods as well as entire meals using this functionality, the insurer, formerly Anthem, said.
Once the information on a meal is logged, it can quickly be added to the member’s health record and then be shared with their provider, with consent, allowing for personalized feedback from their medical team.
Anil Bhatt, global chief information officer at Elevance Health, told Fierce Healthcare that the insurer wants Sydney to be able to offer as much valuable information to the member “at their fingertips” as possible. Elevance Health regularly gathers consumer feedback on features that would most benefit them.
Finally the FEHBlog noticed that NPR Shots is offering useful advice for white collar workers.
After staring at a computer screen for hours at a time, the body often gives us a clue that it is stressed: nagging neck and back pain.
To fix the problem, you might have gotten advice to focus on posture or ergonomics, but exercise research points to another strategy as well – taking short spurts of movement throughout the day to release tension and stress in the body.
“As a society, the assumption is that we have pain because of poor posture and slouching,” says Kieran O’Sullivan, an associate professor of physiotherapy at the University of Limerick’s School of Allied Health in Ireland. “But [the issue] isn’t as neat and tidy as we thought. We have been trying all these fixes [with ergonomics] and it has arguably not fixed the problem. I think it is more about needing breaks from the working day with … movement.”
Here’s how researchers think quick hits of movement – sometimes called exercise “snacks” – may help prevent pain. When the brain senses physical or emotional stress, the body releases hormones that trigger muscles to become guarded and tight. Exercise counters that stress response by increasing blood flow to muscles, tendons and ligaments and sending nutrients to the spine’s joints and discs.
From the Centers for Disease Control’s weekly interpretative summary of its Covid statistics:
New Cases — “As of January 4, 2023, the current 7-day average of weekly new cases (67,243) increased 16.2% compared with the previous 7-day average (57,847). A total of 101,094,670 COVID-19 cases have been reported in the United States as of January 4, 2023. * * *
The most prevalent Omicron lineages this week are BQ.1.1, projected to be 34.4% (95% PI 26.7- 43%); XBB.1.5, projected to be 27.6% (95% PI 14.0-46.5); and BQ.1, projected to be 21.4% (95% PI 16.1-27.7%). XBB, BA.5, BN.1, BF.7, and BA.2.75 are all projected to be between 1% and 5% of circulating viruses.”
New Hospitalizations — “The current 7-day daily average for December 28, 2022–January 3, 2023, was 6,519. This is a 16.1% increase from the prior 7-day average (5,613) from December 21–27, 2022.”
New Deaths — “The current 7-day average of new deaths (390) increased 8.3% compared with the previous 7-day average (360). As of January 4, 2023, a total of 1,091,184 COVID-19 deaths have been reported in the United States.”
Vaccinations — “As of January 4, 2023, 665.1 million vaccine doses have been administered in the United States. Overall, about 229.3 million people, or 69.1% of the total U.S. population, have completed a primary series. More than 48.2 million people, or 15.4% of the U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
Though Covid hospitalizations appear to be on the rise nationwide, experts don’t project this Omicron subvariant alone to cause a spike — forecasts from early data suggest they’ll remain fairly steady, Céline Gounder, an infectious disease specialist and senior fellow at the Kaiser Family Foundation, said. * * *
The prediction matches the data from Singapore, where a related subvariant recently became dominant but didn’t result in a spike in hospitalizations and deaths — though that country’s vaccination rate is higher than that of the U.S.
But some individuals — particularly people who are older or pregnant or have weakened immune systems — are at heightened risk from the virus, regardless of larger population trends.
“I’m a bit concerned with it just because it’s coupled with the extremely low booster rates of those over 65,” Katelyn Jetelina, epidemiologist and professor at the University of Texas Health Science Center, said. “Our most vulnerable aren’t as protected.”
The FEHBlog was encouraged to read this American Hospital Association post about a National Institutes for Health / HHS trial:
The Department of Health and Human Services will launch this month a COVID-19 Home Test to Treat telehealth pilot program in Berks County, Pa. Program organizers will work this year with public health departments to expand the program to 100,000 people in vulnerable communities. Telehealth services provider eMed will implement the program, and UMass Chan Medical School will analyze the impact on participating communities.
“At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, which will launch the program with HHS’ Administration for Strategic Preparedness and Response.
“What is clearer now, compared to even a year ago, is that we can really blunt the worst of [Omicron] by doing the things that we know work,” Dr. Ashish Jha, the White House coronavirus response coordinator, told NPR in an interview.
That includes getting vaccinated and boosted, especially if you’re older. Most deaths from COVID-19 are occurring in people age 65 or older.
Other precautions include avoiding crowded, poorly ventilated parties, restaurants, bars and other places; testing before gathering; and, yes, putting that mask back on in risky situations. And if you do get sick, check with your doctor about getting treatment quickly.
“It is a time not to let your guard down,” warns Dr. Tina Tan, an infectious disease specialist at Northwestern University.
The good news is the worst appears to be over from the RSV surge that has been making life miserable for many children and their parents. RSV cases have been falling steadily since the end of November, according to the Centers for Disease Control and Prevention.
At the same time, the flu — which also came roaring back this fall after mostly disappearing for the previous two years — looks like it’s finally receding in most places, according to the latest data out Friday from the CDC.
From Capitol Hill, Roll Call reports that Rep. Kevin McCarthy (R CA) has been elected House of Representatives speaker. The 118th Congress, therefore, is in session.
The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease.
The [intravenously administered] drug, called Leqembi [scientific name lecanemab], was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.
Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Unless Medicare changes the way it pays for drugs like Leqembi, Eisai expects a relatively slow rollout. * * *
Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The FDA-approved label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% currently living with an Alzheimer’s diagnosis.
The label also mandates that patients undergo three additional brain scans during the first 14 weeks of treatment as a precautionary step to monitor for potentially serious brain swelling or bleeding episodes. * * *
Technically, the FDA granted accelerated approval to Leqembi, a faster path to the market based on preliminary evidence that the drug eliminates toxic amyloid. It’s the same controversial, regulatory shortcut that the FDA used to approve Aduhelm. But unlike Biogen, Eisai within days is expected to submit the cognition data from its positive, confirmatory study to the FDA, which will then consider the drug for full, or final, approval.
BioPharma Dive tells us, “The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.” This keeps the drug on track to be on the market when the Humira patents are lifted on July 1, 2023.
According to a press release issued on January 5, 2023:
Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.
Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people. * * *
Synergie Medication Collective will go to market in January of 2023.
For only the second time since launching nearly two years ago, the AMR Action Fund has announced an investment in a fledgling biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance.
In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The drug, which is about to enter Phase 2 testing, is targeting hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections that originate from pneumonia.
From the health plan design front, EBRI released a study on cost-sharing trends for medical services from 2013-2020.
VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-CityMD Jan. 3, adding more than 2,800 providers to its ranks.
News of the deal’s completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.
VillageMD, established in 2013, operates standalone Village Medical practices, full-size Village Medical practices alongside Walgreens pharmacies, and primary care in the home and virtually.
The combination of Summit Health-CityMD and VillageMD creates one of the largest independent provider groups in the country, according to the companies’ news release. With the buy, VillageMD more than doubles its locations from more than 250 to more than 680 in 26 markets and grows its ranks by more than 2,800 providers. VillageMD declined to share the precise number of providers it now employs, but did say it employs more than 20,000 people.
The addition also strengthens VillageMD’s footprint in five states. Summit Health and CityMD have locations in New York, New Jersey, Connecticut, Pennsylvania and Central Oregon.
Fierce Healthcare discusses the Federal Trade Commission’s proposed rule banning post-employment non-compete clauses in employment agreements on healthcare.
Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday [January 5] will affect almost all industries, experts say.
Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.
The public has 60 days to submit comments before the FTC can make it final.
“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.
Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation “blatantly unlawful.” * * *
Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can’t work for another company for two years after you leave.”
In closing, FedSmith updates us on federal retirement statistics for those interested.
Seasonal influenza activity remains high but continues to decline in most areas.
Of influenza A viruses detected and subtyped during week 51, 83% were influenza A(H3N2) and 17% were influenza A(H1N1).
Fourteen influenza-associated pediatric deaths were reported this week, for a total of 61 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 20 million illnesses, 210,000 hospitalizations, and 13,000 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system was more than 4 times higher than the highest cumulative in-season hospitalization rate observed for week 51 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.
The number of flu hospital admissions reported in the HHS Protect system decreased nationally from the week prior for the third week in a row.
From the No Surprises Act front, STAT News reports
Health care providers are swamping the government with billing disputes under the new law that bans surprise medical bills. So far, just 4% have ended in payment.
That’s according to the Biden administration’s progress report on the No Surprises Act’s so-called independent dispute resolution (IDR) process, in which mediators help out-of-network providers and insurers decide appropriate payment amounts for services. So far, the government is fielding a much higher volume of requests than expected, mostly related to emergency services. Health care providers, air ambulance providers, and companies working for them submitted about 90,000 out-of-network payment disputes between April 15 and Sept. 30, far more than the roughly 17,000 anticipated in a full year.
Also exceeding expectations is the complexity of the cases and the time it’s taking to reach resolutions, which has led to a severe backlog of disputes awaiting resolution. Of the roughly 23,000 cases closed so far, mediators made payment determinations in about 3,600 — 4% of the 90,000 submissions.
In the FEHBlog’s opinion, providers and payers should focus on resolving cases at the initial open negotiation phase. Last week, the NSA regulators announced that the administration cost for one arbitration would increase from $50 to $350 per party, which should encourage payers and providers to reach the FEHBlog’s conclusion.
From the public health front, the Hill relates according to a new CDC report
About 526,000 young Americans could have both Type 1 and Type 2 diabetes by 2060, up from 213,000 in 2017
The expected surge is alarming health officials, who say the increase will disproportionately affect minority populations.
A potential factor behind the trend could be an increase in childhood obesity.
These statistics place in context this STAT News story titled “Wegovy [Novo Nordisk’s latest obesity drug] may help teens with obesity lose weight but isn’t a magic bullet.”
“I’m concerned that doctors are going to rush to judgment and employ a medication that is very expensive and has its own side effects without giving proper consideration of what the actual cause of the problem is,” said Robert Lustig, professor emeritus of pediatrics at the University of California, San Francisco. Wegovy costs more than $1,300 per month and can cause nausea, vomiting, and rare cases of pancreatitis.
Lustig said each teen’s obesity is caused by different genetic, environmental, and behavioral factors and requires tailored treatment. He worries that widespread use of Wegovy could lead physicians to overlook the root causes of an individual’s condition.
“Treating the downstream symptoms of the problem is only putting a Band-Aid on the problem, it’s not fixing the problem,” Lustig said. “I’m worried that Wegovy is a Band-Aid.”
Since Wegovy, Saxenda, and other drugs are meant to be taken over the long term to maintain weight loss — potentially the rest of an individual’s life — teenagers would be on the medication for an especially long time, and there isn’t yet information on the effects of the drug over that time span, Lustig added.
The FEHBlog did not realize that these are long-term drugs.
In other Rx coverage news, the Food and Drug Administration on Wednesday
approvedBriumvi (ublituximab-xiiy) injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Researchers demonstrated Briumvi’s efficacy in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate (ARR) over the treatment period. In both studies, Briumvi significantly lowered the ARR compared to teriflunomide. The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.
Govexec reports on the Postmaster General’s plans for next year.
Milliman suggests “how to understand and impact health plan administrative expenses.”
The New York Times Morning column provides good year-end news: After spiking in 2020 and 2021, murders in large U.S. cities had decreased more than 5% this year and gun deaths, injuries, and mass shootings are also down this year. The Times attributes the drop to Covid’s transition to endemic status.
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