“As of today, patients and physicians have a clear-eyed view on how to protect Medicare from injurious cuts. A bipartisan group of House members— led by Reps. Greg Murphy, M.D., (R-N.C), Danny Davis, (D-Ill.), Brad Wenstrup, D.P.M. (R-Ohio), Jimmy Panetta (D-Calif.), Larry Bucshon, M.D. (R-Ind.) and Michael Burgess, M.D. (R-Texas)—introduced HR 6683 that would eliminate the pending 3.37 percent cuts to Medicare payments. These cuts threaten healthcare access for seniors as well as the viability of physician practices, including many in rural and underserved areas. Canceling the cut is a good new year’s resolution.”
The Federal Benefits Open Season ends tomorrow, December 11.
OPM explains that “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday, December 11, 2023, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday, December 11, 2023.”
From the public health front,
Fortune Well provides background on pneumonia, the lung disease that is the number one cause of hospital admission in children and adults.
Bloomberg Prognosis delves into the old saying, “Feed a cold and starve a fever,” which dates back to the 16th century. Well, it turns out that your best bet is to feed colds and fevers according to Bloomberg.
“The Centers for Disease Control and Prevention on Friday warned clinicians and the public about an outbreak of a rare but deadly tick-borne disease that hospitalized five patients in Southern California, killing three of them, after they traveled to or lived in a Mexican border city in recent months.
“Rocky Mountain spotted fever (RMSF) is transmitted by the bite of infected ticks that live primarily on dogs. It’s rare in the United States but it has emerged at epidemic levels in northern Mexico, where more than 2,000 cases, resulting in hundreds of deaths, have been reported in the past five years.
“In a health advisory issued late Friday, the CDC said the five patients had been diagnosed since late July. All had traveled to or lived in the city of Tecate, in the northern Mexican state of Baja California, within two weeks of getting sick. All five sought care in hospitals in Southern California, including four pediatric patients. CDC officials declined to provide more details about the individuals to protect their privacy. Three of the patients were U.S. residents, and two were siblings who lived in Mexico. Two deaths were pediatric patients and one was an adult, CDC officials said.”
The Post also discusses nitazenes, a street opioid more potent than fentanyl.
“Naloxone, the commonly used overdose reversal drug, can revive nitazene users. But nitazenes may complicate rescue efforts if users or medical personnel do not know the drugshave been consumed. In a study published in August, researchers found that a small group of emergency room patients who had taken nitazenes needed more naloxone than peopleoverdosing on fentanyl. Two patients who ingested a compound known as metonitazene suffered heart attacks. One died, according to the study in JAMA Network Open.
“The concerns about nitazenes being more potent than fentanyl were confirmed by the study,” said Alex F. Manini, a study co-author and a professor of emergency medicine at the Icahn School of Medicine at Mount Sinai in New York.”
We have big news from the U.S. healthcare business front.
“Cigna abandoned its pursuit of a tie-up with Humana that would have created a roughly $140 billion giant in the health-insurance industry.
“The companies couldn’t come to an agreement on price and other financial terms, according to people familiar with the matter. In the near term, Cigna is turning its focus toward smaller, so-called bolt-on acquisitions. * * *
“Instead, Bloomfield, Conn.-based Cigna plans an additional $10 billion of stock buybacks, bringing its total planned repurchases to $11.3 billion. * * *
“Humana, the No. 2 Medicare insurer, remains in the midst of its own succession handoff. Humana said in October that Jim Rechtin—previously chief executive of Envision Healthcare—would take over as president and chief operating officer, effective Jan. 8. Rechtin is then to take over as chief executive officer from Bruce Broussard in the back half of 2024.”
“In a landmark moment for genetic medicine and sickle cell disease patients, the FDA on Friday approved not just one but two gene therapies for the disease: Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, marking the first-ever approval of a CRISPR-based medicine in the US, and Lyfgenia, bluebird bio’s lentiviral gene therapy.
“The treatments are approved for sickle cell disease patients 12 years of age and older who experience painful attacks associated with the disease. Vertex will charge $2.2 million in the US for Casgevy, while bluebird will charge $3.1 million for Lyfgenia.
“This is the very first time that some patients have ever imagined that they might not have to live their entire lifespan with the consequences of sickle cell disease,” Alexis Thompson, the chief of the division of hematology at Children’s Hospital of Philadelphia and investigator on the clinical trials that led to the therapies’ approvals, told Endpoints News ahead of the announcement.” * * *
“ICER, a drug pricing watchdog, has suggested the therapies could be cost-effective at $2 million in the US. Bluebird bio markets a gene therapy as Zynteglo for transfusion-dependent beta thalassemia as well in the US, for which it charges $2.8 million.”
“New polling suggests voters would rather work to improve the current U.S. healthcare system and keep the Affordable Care Act in place, rather than drastically overhaul the system in favor of a national public option or Medicare for All.
“Three-quarters of survey respondents said they prefer fixing the current health insurance system versus starting fresh with a Medicare for All system, while 64% said Medicare should begin at the age of 60 instead of 65 and 58% believe people should be allowed to purchase health insurance beginning at the age of 50.
“Repealing the ACA struck a chord with respondents as just 32% of voters and only 44% of GOP voters said they support repealing the ACA. When asked if ACA subsidies should be extended, 60% said they should while only 41% of Republicans agreed.
“Notably, the survey was conducted on behalf of the Partnership for America’s Health Care Future, an industry group created in 2018 comprised of America’s Health Insurance Plan, the American Hospital Association, BlueCross BlueShield Association, the Federation of American Hospitals, PhRMA and other major hospital systems, payers and healthcare advocacy groups that seek to quell support and prevent passage of Medicare for All.”
“Hospitals are up in arms over a bill in the U.S. House of Representatives that would equalize payments for drugs administered in outpatient clinics, regardless of ownership.
“The American Hospital Association and the Federation of American Hospitals sent separate letters to Congress this week urging legislators to vote against the bill over the site-neutral provision, arguing it would threaten access to care by cutting hospitals’ Medicare payments.
Fierce Healthcare offers more information on this bill (HR 5378).
[T]he legislation would ban spread pricing in Medicaid, force PBMs and providers to adopt President Trump-era transparency rules, push closer toward site-neutral payment reform, extend a federal program due to expire and approve funding increases for community health centers.
The American Hospital Association News points out,
The Medicare Payment Advisory Commission Dec. 8 discussed draft payment update recommendations for 2025, which the commission will vote on in January. The draft recommendations call for Congress to update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1.5%, and transition to a safety-net index policy that would distribute an additional $4 billion to safety-net hospitals. They also propose that Congress:
Update 2025 Medicare payments for physicians and other health professional services by 50% of the Medicare Economic Index increase, and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries.
Reduce the 2025 payment rate for home health agencies by 7%.
Reduce the 2025 payment rate for skilled nursing facilities by 3%.
Reduce the 2025 payment rate for inpatient rehabilitation facilities by 5%.
On December 6, the Biden Administration’s latest semi-annual regulatory agenda was posted. Here is a link to OPM’s agenda. Here are the FEHB rulemakings in process:
OPM Proposed Rule Stage Federal Employee Health Benefits Program: Effective Date of Coverage RIN 3206-AO47
OPM Proposed Rule Stage Postal Service Health Benefits Program: Additional Requirements and Clarifications RIN 3206-AO59
OPM Proposed Rule Stage Federal Employee Health Benefits Program: Decreasing Enrollment Type to Self Only RIN 3206-AO62
OPM Final Rule Stage Requirements Related to Air Ambulance, and Agent, and Broker Services, and Provider Enforcement RIN 3206-AO28
OPM Final Rule Stage Postal Service Health Benefits Program RIN 3206-AO43
Readers can research these rulemakings on regulations.gov by referencing the RIN.
From the public health and medical research front,
The Department of Health and Human Services announced
“In first-of-its-kind research to examine racial and ethnic disparities in the medical costs of smoking in the United States, the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) found that adults from some racial and ethnic populations benefit substantially more than others from tobacco control policies. The research, published today in the journal Tobacco Control, supports President Joe Biden’s April 2023 Executive Order calling for policymakers to examine distributional effects in cost-benefit analyses required in the rulemaking process. This study helps inform such analyses and will benefit other research in this area.
“The study shows that even though adults in specific racial and ethnic populations have a lower ever-smoked rate than White adults and make more attempts to quit, their medical spending associated with smoking was twice as high, with a 41% higher rate of having multiple chronic conditions associated with smoking. * * *
“Disparities in medical spending, as well as adverse health outcomes, are continuing to increase over time,” said AHRQ co-author Dr. William Encinosa. “AHRQ’s results indicate that racial and ethnic populations benefit substantially from tobacco control policies, such as tobacco product regulations.”
“Patients receiving semaglutide for weight loss show a significantly higher rate of continuing the medication at 1 year compared with less effective anti-obesity drugs. However, even among those patients, continuation declines to fewer than half of patients.
“We now have effective US Food and Drug Administration-approved anti-obesity medications; [however], this study shows that in a real-world setting, the vast majority of patients discontinued their prescription fills within the first year,” said first author Hamlet Gasoyan, PhD, lead author of the study and a researcher with Cleveland Clinic’s Center for Value-Based Care Research, said in a press statement.
“An outbreak of Clade I mpox virus is currently spreading in the Democratic Republic of the Congo (DRC), and clinicians should be aware of the potential for transmission from people traveling from the Central African country, the CDC said Thursday in a Health Alert Network advisoryopens in a new tab or window.
“Of the two distinct mpox subtypes, Clade I is endemic in Central Africa, and appears to be more transmissible and causes more severe infections than the Clade II subtype. So far, no Clade I mpox infections have been detected in the U.S. during surveillance testing. The current threat for Clade I mpox in travelers remains low, the CDC said, in part because there are no direct commercial flights to the U.S. from the DRC.”
From the U.S. healthcare business front,
Becker’s Payer Issues explains how BCBS plans are using price transparency data.
“It’s been nearly two years since payers have been required to publish the costs of their in-network provider rates for covered items and services, and now Blue Cross Blue Shield plans are using that data to create actionable insights for stakeholders across the healthcare system.
“Much of that work is being done by Blue Health Intelligence, the data and analytics arm of the BCBS Association that is collectively owned by 17 BCBS affiliates. Becker’s sat down with BHI CEO Bob Darin to learn how Blues plans around the country are utilizing price transparency data, and the major challenges that still lie ahead.”
“The U.S. government published its fall regulatory agenda Wednesday, sharing its rulemaking plans for the remainder of 2023 and early 2024.
“Of interest to HR professionals are U.S. Department of Labor updates on wage and hour law, workplace safety and retirement plans. Perhaps most notably, the DOL plans to finalize overtime regulations in April 2024. Final regulations for independent contractor classification — under the Fair Labor Standards Act — hang in the balance, as they were slated to be published in November, per the DOL.
“With the end of the year quickly approaching, HR and benefits leaders have yet one more task to add on to their busy end-of-year checklist: reminding employees about approaching deadlines to use up remaining cash in their health care flexible spending accounts (FSAs). ***
“So how should employers share end-of-year news about FSAs? And what should they say?
“One of the best ways to remind employees is to send multiple emails during the remainder of the year, Dinich said, adding that if company leaders simply raise the issue in a company meeting, anyone who is on leave or out sick won’t get that reminder.
“Make sure to reiterate any terms and conditions within that email and advise on checking which expenses are eligible, so that employees can refer back to this when making claims before the end of the year,” he said. “Also ensure that it’s clear when the expiry date is, as some plans are tied to specific dates rather than defaulting to the end of the year.”
The White House posted a fact sheet on the steps that the Administration is taking to lower health and prescription drug costs.
Following up on yesterday’s post, BioPharma Dive adds
The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to sidestep patent protections for those medicines.
New draft guidelines published by the National Institutes of Standards and Technology permit government agencies to consider “reasonableness of the price” when evaluating whether to invoke so-called march-in rights, which permit the government to suspend patents when federally funded inventions aren’t made available to the public.
The newly published framework gives agencies the power to act “if it appears that the price is extreme, unjustified, and exploitative of a health or safety need.” One example is a “sudden, steep price increase in response to a disaster,” although the initial cost of a drug when it’s launch can also be considered, the guidance said.
The agency is seeking further comment on its guidance — the product of an interagency review that began early this year — before publishing a final version.
The Senate Finance Committee leadership announced that “the Committee has reported legislation that was marked up in the committee in November. The “Better Mental Health Care, Lower-Cost Drugs, and Extenders Act” addresses a number of important health care priorities in the committee’s jurisdiction.”
“The final reported legislative text can be found here. A section by section summary can be found here.”
“The House Energy and Commerce Committee Dec. 6 advanced 19 health care bills, including legislation (H.R. 6364) that would prevent Medicare from publicizing a telehealth provider’s home address when the provider delivers telehealth services from their home. AHA has additionally urged Congress to remove a requirement that these telehealth providers report their home address on Medicare enrollment and claims forms effective Jan. 1, 2025.
“The committee also advanced H.R. 6545, as amended, which included provisions that were part of two other bills that had previously moved through the health subcommittee: H.R. 6366, to extend for one year the Geographic Practice Cost Index floor for physician work under the Medicare Physician Fee Schedule; and H.R. 6369, to extend the 3.5% incentive payment for eligible Advanced Alternative Payment Model participants for the calendar year 2026 period. AHA supports the extension, but would prefer Congress to restore the incentive payment to 5% and remove the legislation’s payment reductions for longstanding participants.”
MedPage Today offers insights into a December 5 Senate Finance Committee hearing on drug shortages.
The Government Accountability Office issued a report on “improper payments and fraud: how they are related but different.” OPM has focused FEHB carrier attention on this topic in 2023.
In federal benefit news,
FedWeek discusses how FEHB premiums compare for retirees versus employees.
“For the third time this year, the federal government’s backlog of pending retirement claims filed by departing federal workers hit a six-year low, as the Office of Personnel Management continues its focus on improving a process that has long pestered agencies and retirees alike.
“OPM reported Tuesday that its retirement backlog fell to 15,826 pending cases at the end of November. That’s the second time the inventory fell below 16,000 this year, and the third time this year that the backlog reached a six-year record low, dating back to when it briefly felt to around 14,000 in 2017. OPM’s goal is a “steady state” of 13,000 pending claims at any given time.
“In 2023, the retirement backlog has fallen in seven out of 11 months. Last month, the average processing time fell across multiple metrics. Measured on a monthly basis, the average processing time of a retirement claim fell from 73 days in October to 66 last month. And the average processing time so far this fiscal year—or since Oct. 1—fell from 73 at the end of last month to 69 days.”
From the public health and medical research front,
The Washington Post offers helpful advice on wounds that aren’t healing properly.
JAMA Network posts observations on GLP-1 drugs from last October’s Obesity Week meetings. Of note,
“Jacinda Nicklas, MD, MPH, gave a talk at the conference showing that females often respond better to newer antiobesity medications than males.
“Something that we’re gradually becoming more aware of over time is that GLP-1s, in general, seem to work better in females,” Nicklas, an associate professor of internal medicine at CU School of Medicine who specializes in obesity and women’s health, said in an interview with JAMA.
“Nicklas did not present new research, but instead combed through past studies of GLP-1 agonists. She said sex differences haven’t often been separated out in studies and that the majority of participants in the clinical trials are females.
“Digging into the data from the STEP trials of semaglutide, she said females had greater weight reduction than males. The same was true in a phase 2 clinical trial of retatrutide for treatment of obesity without type 2 diabetes. Participants who received the highest dose lost an average of 24% of their body weight but females lost much more: about 29% compared with about 20% for males.”
MedPage Today tells us that an “Alzheimer’s Blood Test Predicts Who Might Benefit Most From Anti-Amyloid Drugs — Novel two-cutoff approach may reduce need for confirmatory PET scans.”
From the U.S. healthcare business front,
Beckers Hospital Review points out that “U.S. News and World Report released a list December 5 recognizing hundreds of hospitals for maternity care.” Becker’s article includes that list.
“CVS is planning to release a new mobile healthcare app designed to function as a central hub for its healthcare services.
“The app, teased in a video at the company’s Dec. 5 investor meeting, can help consumers manage their prescriptions while providing access to informative health tips.
“Some of the app’s other features include an augmented reality store navigation and a function that allows consumers to schedule appointments at CVS MinuteClinics and CVS-owned Oak Street Health.
“An AI-powered chatbot will also be integrated into the app so consumers can get their questions answered.
“CVS did not detail when the app would be released.”
“Merck & Co. is ending a late-stage study of the combination of Keytruda and Lynparza in certain lung cancer patients due to an expected failure of the trial.
“The Rahway, N.J., drugmaker, which was evaluating Keytruda in combination with maintenance Lynparza in a Phase 3 study in patients with metastatic squamous non-small cell lung cancer, said it is stopping the trial for futility based on the recommendation of an independent data monitoring committee.”
“The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, according to three sources familiar with the plans. It’s an early step that could have major ramifications for the American pharmaceutical industry, depending on whether and how federal officials actually use the authority.
“The administration will on Thursday issue a framework for the National Institutes of Health to more broadly use so-called “march-in rights” — a policy that allows it to seize patents from drugmakers whose products rely on federally funded research, according to the three people familiar with the plans. The framework will lay out when the agency might assert this authority, and endorse using a drug’s price in that determination, the sources said. * * *
“[T]he framework will likely include a number of conditions limiting its use, two sources said. The public — including pharmaceutical companies — will also get the chance to weigh in on the idea before it is finalized.”
Neverthless, the FEHBlog hears the litigation turbobillers revving up.
“A bipartisan group of senators this week introduced the Protect Rural Seniors’ Access to Care Act, AHA-supported legislation that would prohibit the Health and Human Services Secretary from finalizing a proposed rule on minimum staffing for long-term care facilities.
“AHA has urged the Centers for Medicare & Medicaid Services not to finalize the rule and instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.
“Over 90 organizations have endorsed the bill, introduced by Sens. Deb Fischer, R-Neb., Roger Marshall, R-Kan., Jon Tester, D-Mont., James Lankford, R-Okla., Joe Manchin, D-W.Va., Roger Wicker, R-Miss., Kyrsten Sinema, I-Ariz., Susan Collins, R-Maine, and Angus King, I-Maine.
“Rep. Michelle Fischbach, R-Minn., introduced a House version of the bill in September.”
Fingers crossed for the bill to enacted. The HHS rule is short sighted.
In FEHB Open Season news, Govexec, Federal News Network, and FedWeek offer tips for last-minute shoppers as we approach the end of the Federal Benefits Open Season next Monday. What’s more, FedWeek offers advice on protecting your survivor’s access to FEHB coverage.
From the public health and medical research front,
“Covid-19 test positivity rates increased over the summer and then stabilized earlier this fall. They have recently ticked back up, rising 1.2% for the latest week, according to the CDC’s most recent data. Emergency department visits and hospitalizations are up about 10% over the same period.
“Scientists and public-health officials say that data understates the current virus spread and point to elevated levels of the virus detected in wastewater. Wastewater levels are an early warning for infections, with levels up nationally since mid-October. * * *
[Variant] JN.1 * * * is growing rapidly on a global level, says Jesse Bloom, a virologist and professor at Fred Hutchinson Cancer Center in Seattle. It has quickly spread in countries such as France and England. JN.1 has been detected in the U.S., though only as a blip.
Epidemiologist Katelyn Jetelina, a scientific adviser to the CDC and author of the “Your Local Epidemiologist” newsletter [available on Substack], says that while JN.1 isn’t growing as fast as the original Omicron in the winter of 2021-22, its current rate of growth could fuel a wave in Covid-19 cases.
“If that rate continues, we should see dominance in the U.S. around Christmastime, which means that it would really jump-start a wave around New Year’s,” she says.
The good news, says Bloom, is that research indicates the new booster—developed to protect against the XBB variants that were dominant this summer—appears to work for the more mutated newer variants, too.
Here’s a link to the National Cancer Institute’s research newsletter.
“More than a third of mothers — around 40 million women — are affected by lingering health issues after giving birth, according to a new study published Dec. 6 in The Lancet Global Health.
“However, many of the issues they report experiencing after giving birth extend long after they stop receiving postpartum care, which is where the major issues lie, according to the researchers.
“The authors found that after giving birth, 32% of women report low back pain, 19% experience anal incontinence, 11% experience perineal pain, 8-31% are affected by urinary incontinence, and around 11% are affected by secondary infertility issues. Mental health issues like anxiety and depression are also pervasive.”
“Eli Lilly & Co.’s new weight-loss drug Zepbound is now available at US pharmacies, offering an alternative to rival medications like Novo Nordisk A/S’s Wegovy as supply issues persist.
“Zepbound was approved by the US Food and Drug Administrationin early November as a treatment for people with obesity. Patients with a prescription from their doctor will now be able to get the drug, which was added to the list of available drugs for Express Scripts and Cigna Healthcare this month, Lilly said in a statement Tuesday.”
“Per the deal, AbbVie will pay $45 per share of Cerevel, which is developing medicines for schizophrenia, dementia and Parkinson’s disease. The buyout price is 22% higher than Cerevel stock’s closing price Wednesday and 73% above what shares closed at Friday, before rumors of a pending deal emerged.
“Both companies’ boards of directors have agreed to the acquisition, which they expect will close sometime around the middle of next year.”
“Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions.
“CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order.
“The pharmacy will also use push notifications to keep members up-to-date on their prescriptions and will allow them to use text messaging to connect directly with representatives.”
“Many of the past year’s buzziest topics and omnipresent struggles will likely rear their heads as major talking points across 2024, per the year-ahead predictions of Deloitte’s healthcare industry heads.
“A disruptive pandemic, rapid digital transformation and mounting cost pressures have taken their toll on the industry’s decisionmakers, Deloitte’s healthcare sector leader Tina Wheeler and senior manager of its health solutions center Wendy Gerhardt wrote in a Wednesday outlook writeup.
“The pair highlighted a recent annual survey of 60 executives that found that only 3% of health system executives and 7% of health plan executives had a “positive” outlook for the coming year—down from the respective 15% and 40% of the prior year’s survey.
“However, there are some bright spots to consider as the industry undergoes convergence,” which the authors described as “the disruption of traditional health care stakeholders, entrance of new players like retailers and tech companies and the reassembly of a new ecosystem that creates opportunities.”
“Cardiovascular, diabetes, and obesity treatments are a critical part of women’s health, and employers can take steps to ensure that women have access to information and care related to their hearts, a flipbook from Northeast Business Group on Health (NEBGH) emphasized.
“With women comprising more than half of today’s workforce, employers are making women’s health and well-being a top priority, and rightfully so,” Candice Sherman, chief of executive officer of NEBGH, said in the press release.
“Cardiovascular disease in women is underdiagnosed and undertreated. Employers can play an important role in raising awareness and educating employees about heart disease and risk factors like diabetes and obesity as well as providing wellness and benefit programs that support women’s health. We developed this guide to give employers a tool to develop ways to improve the overall heart health of their workforce.”
“The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation.
“The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers — and specifically the committee’s chairman, Sen. Bernie Sanders (I-Vt.) — no longer view the issue as a priority.
“If passed, the legislation would mark Capitol Hill’s first major action this year on the addiction crisis. Current data shows that roughly 110,000 Americans are dying of drug overdoses each year. Roughly 85,000 of those overdoses involve opioids.”
The Department of Health and Human Services announced,
“Today, United States Surgeon General Dr. Vivek Murthy is launching the 5-for-5 Connection Challenge, calling on Americans to take five actions over five days to build more connection in their lives. Dr. Murthy recently issued this challenge to students across the country on his “We Are Made to Connect” College Tour, which concluded just last week. Now, as we enter the holiday season, the 5-for-5 Connection Challenge aims to inspire people of all ages to build, strengthen, and prioritize their relationships.
“For the next two weeks, from December 4th – December 15th, the Surgeon General will encourage people to take five actions over five days that express gratitude, offer support to, or ask for help from people in their lives. These types of actions are outlined in the Surgeon General’s Advisory on Our Epidemic of Loneliness – PDF as some of the ways that people can catalyze social connection. As outlined in the Advisory, social connection can advance physical, mental, and cognitive health, and it is even associated with a decreased risk of mortality.”
“The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
“Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
“The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.”
In FEHB Open Season news, Govexec offers helpful, last-minute advice from Kevin Moss.
From the public health and medicare research front,
“After a period of limited change, COVID-19 activity is increasing again especially in the Midwest and Mid-Atlantic regions,” the CDC said in a report published Friday.
“Federal health officials are likely watching the increase given that they expect a “moderate” winter wave of coronavirus and this could be the start of it. Holiday gatherings and travel are also typically followed by an increase in coronavirus cases and hospitalizations.
“COVID-19 vaccination rates, meanwhile, have been disappointing for many.
“CDC Director Mandy Cohen told Congress this week that about 16% of Americans have gotten the updated COVID-19 vaccine.
“So far this year, the CDC estimates there have been at least 1.8 million illnesses, 17,000 hospitalizations, and 1,100 deaths from flu in the U.S.
“Influenza A continues to be the dominant strain in circulation, making up around 82% of cases, while influenza B is only accounting for around 18%.
“Louisiana and South Carolina are still reporting the highest levels of flu activity in the country.
“Nine states are experiencing high activity levels, but less than the two states above, including: California, New Mexico, Texas, Mississippi, Alabama, Georgia, Colorado, Florida and Tennessee.
“Cases are also high in New York City and Puerto Rico.”
The Journal of the American Medical Association presented the following study results:
“Question Is smoking still decreasing among US adults and do the trends vary by age, income, and race and ethnicity?
“Findings In this cross-sectional study of 353 555 adults responding to the 2011 to 2022 National Health Interview Surveys, adults younger than 40 years had dramatic declines in smoking prevalence during the last decade, especially among those with higher incomes. In contrast, relatively slow declines were observed among adults aged 40 to 64 years, with no decrease in smoking among those 65 years or older.
“Meaning These findings suggest that the precipitous decline in smoking among younger adults should be maintained, but that additional efforts are required to further reduce smoking in older adults.”
The American Medical Association explains “What doctors wish patients knew to improve their mental health.”
Per Endocrinology Advisor, “Decreased mortality risk is associated with concomitant reductions in glycated hemoglobin (HbA1c) and body weight among patients with type 2 diabetes, according to study results published in Diabetes Obesity and Metabolism.”
From the U.S. healthcare business front,
Fierce Healthcare profiles ten women of influence in U.S. healthcare. Check it out.
“Roche will pay $2.7 billion upfront for the Berkeley, California-based Carmot. Roche could owe as much as $400 million more in future payments to Carmot shareholders, among them The Column Group and RA Capital, if certain milestones are met. The companies expect the acquisition to close next year.
“The deal hands Roche a trio of drugs in human testing for obesity, an area of pharmaceutical research that has been catalyzed by the success of weight loss medicines like Wegovy and Zepbound. Their progress has fueled a gold rush among large drugmakers, a number of which are either advancing in-house medicines or inking deals to acquire new prospects.”
“The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.
“Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.
“With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.”
HR Dive discusses “Why EAPs go unused despite growing mental health awareness; Many factors contribute to the historic underutilization of employee assistance programs, despite their value as an access point to quality care.”
Medscape offers an infographic on how doctors grade their EHR systems while MedCity News explains how improved coding quality by healthcare providers can prevent denials and improve cash flow.
“Payers are investing in healthcare IT resources to support cost optimization and improve member experience, according to a study from EY-Parthenon and KLAS Research.
“As payers face operational and financial pressures, they are turning to healthcare IT solutions for help. Researchers sought to understand what strategies payers prioritize, how much they spend on healthcare IT resources, and what future investments look like.
“The study findings reflect responses from over 100 executives across payer entities serving commercial, Medicare, and Medicaid populations. Around 70 percent of respondents were traditional payers; the remaining were provider-sponsored, third-party administrators, and management services organizations.”
“A merger between major health insurers Cigna and Humana would go through the wringer of an intense antitrust review, but could come out finalized, experts say.
“Though, to receive the regulatory green light, a combined company would probably have to emerge looking different from the Cigna and Humana of today. * * *
“Gaining regulatory approval — especially if a challenge further ties up the process in the courts — could set a deal’s finalization back by a year or more. But, due to a lack of direct competition between the two, Cigna and Humana could be allowed to combine, creating a healthcare powerhouse with roughly $300 billion in annual revenue.”
“For-profit hospital chain HCA Healthcare’s Houston affiliate announced last week it completed its acquisition of 11 free-standing emergency departments from SignatureCare Emergency Centers.
“HCA Houston Healthcare, which operates a network of 13 hospitals and nine outpatient surgery centers, now has 26 free-standing emergency departments in the area in addition to hospital-based emergency rooms, according to a Friday press release.
“Rural hospital chain Lifepoint Health and Ascension Saint Thomas announced a joint venture last week to co-own Highpoint Health, a four-hospital system in Tennessee currently operated by Brentwood, Tennessee-based Lifepoint.
“The hospitals and care sites will be co-branded with Ascension Saint Thomas, but will be majority-owned and operated by Lifepoint, according to the release. The companies declined to comment on the cost of the buy-in.
Roll Call offers a preview of Congress’s actions over the next month, after which point the first session of this 118th Congress will come to a close.
Bloomberg provides an update on ongoing efforts to revamp the Nation’s organ transplant system. Here are the highlights:
“First contract bid solicitations from HHS expected this fall, and
“Multiple vendors to run transplant system for first time.”
The Centers for Medicare and Medicaid Services published in today’s Federal Register corrections to its Section 111 reporting civil monetary penalty rule which was issued on October 11, 2023. CMS asserts that the corrections fix “typographical and technical errors in the final rule, and it does not make substantive changes to the policies or the implementing regulations that were adopted in the final rule.”
The Department of Health and Human Services announced,
“As part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra today announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures.
“President Biden will issue a Presidential Determination broadening HHS’ authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages.”
“approv[ing] Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
“Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.”
The HHS Inspector General concluded that “The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022.”
“The U.S. Postal Service is planning to hire just 10,000 temporary employees during the current holiday season as part of a new approach that management has acknowledged comes with some risks.
“The seasonal hiring marks a 64% reduction from the employees brought on in 2022 during what USPS calls its “peak season” when the agency made 28,000 temporary hires. The agency had said it would bring on just 20,000 seasonal workers that year, but a recent USPS inspector general report found it reached a higher tally.
“This will mark the second consecutive year in which the Postal Service significantly reduces its seasonal hiring. In 2021, USPS added 45,000 non-permanent staff for the holiday rush. Postmaster General Louis DeJoy has said additions to the permanent, career workforce has lessened the need for such a surge. In the last two years, the agency has converted 150,000 employees from part-time workers to full-time, career personnel.”
“Participants in [OPM’s] Thrift Savings Plan felt less content with the TSP this year, according to the latest results of the Federal Retirement Thrift Investment Board’s annual satisfaction survey.
“Currently, 82% of TSP participants are satisfied with the plan, compared with an 87% satisfaction rate in 2022, the board’s survey of tens of thousands of TSP participants showed.
“The slumping satisfaction scores may not come as a surprise after the TSP’s tumultuous transition to a new recordkeeper in June 2022. The 2023 survey, conducted between March and May of this year, was the first time the major update was reflected in the annual participant satisfaction survey.”
From the public health and medical research front,
“The World Health Organization (WHO) today reported that the multi-country mpox outbreak continues at a low transmission level in the European Region and the Americas.
“The 30th WHO Situation Report, published on November 25, 2023, offers insights regarding the latest epidemiology and a particular focus on the ongoing and evolving epidemiology of mpox in the Democratic Republic of the Congo (DRC).
“The WHO confirmed that from January 2022 through October 31, 2023, a cumulative total of 91,788 laboratory-confirmed cases of mpox, including 167 deaths, have been reported from 116 countries/territories/areas.
“The countries that have reported the highest cumulative number of mpox cases are the United States (30,771), Brazil (10,967), and Spain (7,647).”
“Eating disorder claims in the United States rose 65% as a percentage of all medical claims over the last 5 years, according to a report from FAIR Health, a health care claims repository.
“Researchers at FAIR Health evaluated more than 43 billion private health care claims records to investigate trends in eating disorders from 2018 to 2022 based on regional and national levels, demographic and socioeconomic factors and other health conditions. * * *
“Key takeaways:
“Patients aged 14 to 18 years accounted for most eating disorder claims in 2022.
“Overall, 72% of patients with eating disorders were diagnosed with at least one co-occurring mental illness.”
“Eli Lilly’s Mounjaro helped patients lose weight more effectively than Novo Nordisk’s Ozempic, according to a preprint study that included more than 40,000 patients.
“The research evaluated 41,223 EHRs of overweight or obese patients taking Mounjaro (tirzepatide) or Ozempic (semaglutide) for Type 2 diabetes. The cohort was restricted to patients with available weight data and those who had not received a glucagon-like peptide-1 receptor agonist prior to May 2022.
“Although about 77% of the patients took Ozempic, those who took Mounjaro “were significantly more likely to achieve 5%, 10% and 15% weight loss and experience larger reductions in weight at 3, 6, and 12 months,” the study found.
“Truveta, a healthcare data company that collects EHR information from more than 30 systems, conducted the research. It is the first real-world comparative effectiveness study between Mounjaro and Ozempic, Truveta said in a Nov. 27 news release.”
“The inflammation-targeting therapy Dupixent succeeded in a Phase 3 trial in patients with the chronic lung disease COPD, its developers said Monday, results that could propel the blockbuster medicine into a massive new market.
“Dupixent, which is jointly developed by Sanofi and Regeneron Pharmaceuticals, has already racked up approvals for several indications, including asthma, atopic dermatitis, and eosinophilic esophagitis. If approved for COPD, it would be the first biologic treatment for the condition.
“The trial, dubbed Notus, was the second Phase 3 trial for Dupixent in COPD, with the companies announcing similarly positive results from the Boreas trial earlier this year. The full data from Boreas were published in the New England Journal of Medicine.”
From the U.S. healthcare business front,
Employee Benefit News offers tips on PBM contracting.
“Mark Cuban Cost Plus Drug Company has inked its latest partnership, joining forces with Expion Health to address the rising cost of specialty drugs.
“Cost Plus Drugs’ pricing model will integrate into Expion’s dynamic pricing technology, harnessing the power of both for speciality medications. Expion’s tool and Cost Plus Drugs’ approach together “equips payers with a sophisticated tool for navigating this modern landscape,” the companies said in the announcement.”
“Ayble Health, a digital health platform for patients with chronic gastrointestinal conditions, has announced a new collaboration with the Mayo Clinic.
“Ayble is working with the Mayo Clinic Complex Care Program to offer a hybrid care model that matches patients with the appropriate virtual and in-person care based on acuity and need.
“By matching the right care for a patient at the right time, the two hope to improve outcomes and costs for digestive diseases. The collaboration is available for large employers and health plans.”
“AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago.
“The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio.”
“Advocate Health’s financial performance dipped in the third quarter despite rising patient volumes as the major nonprofit health system navigated higher expenses and declining investment returns.
“Advocate’s investment income also took a hit, falling more than a third from midyear. Overall, the nonprofit’s bottom line dropped to $721.2 million, 28% lower than midyear. * * *
“Formed out of a merger between Illinois-based Advocate Aurora Health and North Carolina-based Atrium Health last year, the health system is comprised of three divisions: Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist. Together, the divisions operate more than a thousand care sites, including 67 hospitals.”
Following this post, The FEHBlog will reappear on Saturday for Cybersecurity Saturday. The FEHBlog wishes his readers a Happy Thanksgiving.
From Washington DC
Thanks to Bloomberg, the FEHBlog learned about this Congressional Research Service report on FY 2024 USPS Appropriations. To wit,
“On September 30, 2023, Congress passed the Continuing Appropriations Act, 2024 and Other Extensions Act (H.R. 5860; P.L. 118-15), which provides continuing FY2024 appropriations to federal agencies through November 17,
“Section 126 of the act increases the rate of funding for the Office of Personnel Management (OPM) to approximately $219.1 million, which is about $28.3 million above its FY2023 funding.
“The additional OPM funding is provided for the implementation of the Postal Service Health Benefits Program (PSHBP), a new health benefit program for eligible postal employees and retirees. Under the PSRA, OPM is required to establish and administer the PSHBP.”
FEHBlog note — The Postal Service also is on the financial hook for funding implementation of the PSHBP.
“Senate Democrats, led by Sen. Bernie Sanders (I-Vt.), on Tuesday mounted a public pressure campaign to get the executives of Merck, Johnson & Johnson, and Bristol Myers Squibb to testify in a January hearing on why the United States pays more for prescription drugs than other countries.
“All three companies have sued the Biden administration over the new Medicare drug price negotiation that congressional Democrats passed last year. Bristol Myers Squibb’s blood thinner Eliquis; Johnson & Johnson’s blood thinner Xarelto, anti-inflammatory medicine Stelara, and blood cancer treatment Imbruvica; and Merck’s diabetes drug Januvia were selected as part of the first 10 drugs to go through the negotiation process.
“It’s unclear whether the executives will agree to testify at the hearing, which is titled “Why “Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?” Sanders also put out a fundraising email just before the letter was announced, with the subject line: “The greed of the pharmaceutical industry is out of control.” It featured an op-ed he wrote for the Guardian Monday.”
The second Federal Times article is a topic that the FEHBlog follows throughout the year. In that regard, Mercer Consulting released the following survey findings last week:
“Mercer, a business of Marsh McLennan (NYSE: MMC), released the findings of its 2023 National Survey of Employer-Sponsored Health Plans, which found the average per-employee cost of employer-sponsored health insurance rose by 5.2% in 2023 to reach $15,797. * * *
“In 2022, cost rose by 3.2%, well below general inflation, which averaged 8% that year. Because healthcare providers typically have multi-year contracts with health plans, employers did not feel the full brunt of inflation last year. “Rather, inflation-driven cost increases are phasing in as contracts are renewed,” says Sunit Patel, Chief Health Actuary, Mercer. The survey shows employers project another sharp increase of 5.2% for 2024.
“It may take another couple of years for price increases stemming from higher healthcare sector wages and medical supply costs to be felt across all health plans,” Mr. Patel says.
“At the same time, inflation is only one factor behind this year’s higher cost increases. In 2023, spending on prescription drugs rose sharply. “While the effects of inflation may be relatively short-lived, new and ongoing developments in the pharmaceutical market seem likely to have a longer-term impact on health benefit cost.”
“Federal employees’ retirement applications take almost twice as long to process when they contain errors, leading to further delays in processing and dispensing annuities, according to a watchdog report published Monday.
“The Office of Personnel Management’s inspector general found that “healthy” application packages took on average 53 days to process, and “unhealthy” ones containing errors took more than 108 days, according to a random sample of applications the inspector general studied.
“That discrepancy needs be reflected in the data OPM reports monthly to accurately monitor whether retirement processing is improving, the IG report said.
“The lack of transparency for healthy versus unhealthy ‘incomplete’ application packages limits the quality of information being provided to external parties as the main cause for why Retirement Services has not met its goal for processing retirement application packages within 60 days,” according to the report.”
From the public health and medical research front,
“Hospital and public health officials are urging people to take precautions and be mindful of where they seek care to limit capacity strain on emergency departments as respiratory virus activity heats up heading into the holiday season.
“Since early September, COVID-19 metrics had mostly been trending downward or remained flat. Now they are on the rise again, though they remain far below levels seen in previous surges. There were 16,239 new admissions for the week ending Nov. 11, up 8.6% from the previous week.
“Meanwhile, most of the country is seeing an uptick of flu and respiratory syncytial virus cases. Hospitalizations associated with the two infections are also ticking up, particularly among children and older adults.
“The more concerning thing is the severity of some of the illness,” Hany Atallah, MD, chief medical officer Jackson Memorial Hospital in Miami, told ABC affiliate WPLG. “And we are also seeing some patients come in with more than one viral infection, so they may have RSV and flu, for example. We’re constantly trying to follow the science and encourage people to get vaccines.”
“Ozempic, Wegovy and their counterparts have exploded in popularity over the past year, earning billions for the drugs’ makers, transforming the American approach to weight-loss, and sparking widespread cultural discussion in a country that is already obsessed with weight.
“That conversation lands on Thanksgiving tables this week, where some people say the drugs have boosted their confidence around food, and others say they are worried about facing questions about what they’re eating, what they’re not eating, and changes in their appearance.
“It’s a hot topic, and people have a lot of judgments,” says Dr. Gauri Khurana, a psychiatrist in private practice in New York City and a clinical instructor at Yale University who has prescribed the medications and helped patients manage them. * * *
“Doctors advise people to listen to their bodies—not their family members—when it comes to serving sizes. A balanced plate that gives priority to protein and high-fiber foods over carbohydrates and fatty foods, which tend to sit in the stomach and exacerbate the medication’s effects of delayed gastric emptying, can help patients avoid filling up too quickly or feeling nauseous.”
“Just in time for the holiday season, the Biden administration is offering Americans a fresh round of free at-home coronavirus tests through the Postal Service.
“Beginning Monday, households may order an additional four tests. Households that have not placed an order since the program resumed can submit two orders, for eight tests in total.”
“A new survey of 158 hospital executives, conducted by the Sepsis Alliance, found that 90% see antimicrobial resistance (AMR) as a threat, and 88% think the problem is getting worse. The survey, conducted by Sage Growth Partners on behalf of the Sepsis Alliance, also dug into executives’ views on other related AMR issues. An 11-page report on the findings was published on the Sepsis Alliance websiteon November 17.
“Another top concern is the public’s lack of knowledge about AMR, with 59% of executives saying that public education of clinicians as well as patients is the largest barrier to antibiotic stewardship. Respondents recommend public service announcements covering the need for early treatment, the importance of completing treatment, and storing the drugs properly.”
The Institute for Clinical and Economic Review announced,
“[I]t will assess the comparative clinical effectiveness and value of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD).
“The assessment will be publicly discussed during a meeting of the Midwest CEPAC (Midwest CEPAC) in June 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
Healthcare Dive asks “Where are all the nurses? Hospitals, advocates disagree on crisis; Hospitals and nursing unions disagree about what’s driving sluggish application rates for open registered nurse positions — a lack of qualified candidates or a lack of interest.”
“Roche’s Genentech unit is partnering with computing giant Nvidia in a multiyear deal that highlights the pharmaceutical industry’s growing hopes of using artificial intelligence to speed up the process of designing and developing new drugs.
“By collaborating with Nvidia, Genentech expects to “significantly enhance” its existing AI research and potentially improve on the chip designer’s own software, such as its “BioNemo” platform for drug discovery.
“Our teams will be continuously exchanging expertise on the advancement of science and the state-of-the-art methods emerging in accelerated computing, AI and simulation across this entire drug discovery process,” said Kimberly Powell, vice president of healthcare at Nvidia, in a briefing with reporters.”
President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerateclinical breakthroughs.
Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
“The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
“Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
“OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
“Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
“Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
The Government Accountability Office issued a report on the composition of the federal workforce.
“The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
“We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
“The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
“The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
“The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
“Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
“CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”
In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.
From the public health and medical research front,
“Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
“With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
“Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government. Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
The Wall Street Journal reports,
“The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
“The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products.
“The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana, Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
“The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
“The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
“We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
[B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.
Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year.
For-profit operator Tenet Healthcare has agreed to sell three of its hospitals in South Carolina for about $2.4 billion in cash to Winston-Salem, North Carolina-based Novant Health.
Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward payingdebt, Tenet said in a news release.
Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract.
and
CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.
“Senate Majority Leader Chuck Schumer (D-N.Y.) on Monday said he is “pleased” with Speaker Mike Johnson’s (R-La.) plan to avoid a government shutdown.
“Schumer noted that Johnson’s “laddered” stopgap spending bill — which funds four bills through Jan. 19 and the remaining eight through Feb. 2 — is “far from perfect,” but indicated the “clean” measure provides a path to funding the government for the next two months.”
The Department of Health and Human Services tells us,
“Today, amid new data released on substance use across the nation, the Biden-Harris Administration reiterated President Biden’s clear and urgent call for Congress to provide critical additional resources to strengthen addiction treatment and crack down on drug trafficking.
“Today’s new data from the 2022 National Survey on Drug Use and Health (NSDUH) show there were more than 48 million Americans who experienced a substance use disorder in 2022. Of the 48 million Americans struggling with substance use disorder, three out of every four did not get treatment. While the Biden-Harris Administration has made historic progress in expanding access to life-saving public health services and stopping the flow of illicit drugs like fentanyl into American communities, the nation is facing an unprecedented epidemic that requires the full support and funding of Congress.”
“The Office of Personnel Management on Thursday released new guidance spelling out ways that federal agencies can implement a recent executive order aimed at making it easier for military spouses to have a career in public service. * * *
“In a memo to agency heads, OPM Director Kiran Ahuja said the government’s forthcoming strategic plan for hiring and retaining military spouses will be released later this year. But in the meantime, she offered a few avenues where agencies can take action now to improve their performance on the issue.”
“The gap in life expectancy between men and women in the United States grew to its widest in nearly 30 years, driven mainly by more men dying of Covid and drug overdoses, according to a new study in The Journal of the American Medical Association.
“In 2021, women had a life expectancy of 79.3 years, compared with 73.5 years for men, the study found.
“It was unsettling to see,” said Dr. Brandon Yan, a resident physician at the University of California, San Francisco, and lead author of the study, which analyzed death data from the Centers for Disease Control and Prevention.
“We need to understand which groups are particularly losing out on years of life expectancy so interventions can be at least partially focused on these groups,” Dr. Yan said.”
“The decline in life expectancy in the U.S. suggests that advancements in medical treatment are no longer sufficient to counter ongoing public health crises, Yan said. “We have a health care system that is very advanced in treating illnesses and advanced disease. But for the most part … it is not very good when it comes to preventative care.”
FEHBlog note — The English were tracking life expectancy in the late 1600s.
“Thousands of women will avoid suffering breast cancer after a pill that costs 4p a day was approved as a preventive treatment for the disease.
“Almost 300,000 women at higher risk will be eligible for anastrozole, which studies have shown can nearly halve the chances of developing breast cancer if taken daily for five years.
“Campaigners hailed the approval as a “major step forward” in efforts to tackle the disease, which is Britain’s most common cancer, with 47,000 new diagnoses each year. Until yesterday, anastrozole had been licensed for use in Britain only as a treatment, rather than a preventive measure.
“NHS England said 289,000 women in their 50s and 60s at moderate or high risk of breast cancer would now be eligible for the drug. They will include women with a family history of the disease, or who have faulty genes such as BRCA1, the so-called Jolie gene, that put them at greater risk.”
“Like the better-known tamoxifen, anastrozole was first used to treat breast cancer. Then, because risk doesn’t end with treatment, the hormone-blocking drug was also prescribed to prevent cancer’s return. Ten years ago, after a clinical trial showed convincingly that the drug could prevent breast cancer, U.S. oncologists began prescribing it off-label. In the U.K., anastrozole got the nod for this use last week from the country’s Medicines and Healthcare products Regulatory Agency. * * *
“The two drugs approved by the U.S. Food and Drug Administration for prevention, tamoxifen and raloxifene, reduce estrogen in different ways but offer the same kind of protection. Brewster said they are used more often in the U.S. than anastrozole, possibly because of milder side effects. * * *
“These prevention drugs themselves are not without risk. As [Dr. Abenaa] Brewster [a professor of clinical cancer prevention at MD Anderson Cancer Center] puts it, there’s no such thing as free lunch, and when patients are healthy, their tolerance for side effects is understandably lower than when they are in treatment for active disease. Most women tolerate tamoxifen well, but there are rare side effects of uterine cancer or blood clots. Some patients taking anastrozole and raloxifene experience joint stiffness, vaginal dryness, hot flashes, or bone thinning.”
“The changing nature of the drug crisis was predictable, because drug use is historically faddish. In the 1970s, America struggled with heroin. In the ’80s, it was cocaine. In the ’90s and early 2000s, meth. Since then, opioids have taken off.
“One explanation for this is what’s known as generational forgetting: Young people tend to avoid the drug that is currently causing a crisis. But because they don’t have personal experiences with the drugs that caused harm before their time, they are more willing to use those substances.
“Different drugs can also complement each other, and so their popularity can rise simultaneously. Opioids, for example, often cause users to doze off, which can leave those who live on the streets vulnerable to theft or rape. So opioid users sometimes use stimulants, like meth and cocaine, to stay awake. And if they receive treatment for opioid addiction, they may continue using stimulants.
“All of this leads to a revolving door for different kinds of drug crises. It has happened before, and it is happening again.
“Read Jan’s full story, which includes details about the rise of a kind of meth so pure that some are calling it “super meth.”
Mercer Consulting offers a Q&A about weight loss medications with their pharmacy team.
Do these medications have an ROI? When might plan sponsors expect to see benefits from treating obesity as a chronic disease?
Jon Lewis, Mercer Rx Financial Leader: These medications represent a big investment. While everyone talks about the high list prices, it is worth noting something fairly unique here. We do have manufacturer competition which means rebates are playing a role and should be monitored.
In general though, we are looking at somewhere between three to five years before you start to realize any savings. Those who are at higher risk – for example, people with a higher BMI – are likely to produce more savings. With that said, changing eligibility to a narrower BMI does have a rebate impact and should be incorporated into any weight loss strategy.
But these drugs are costly. You would have to have someone who is on the drug long enough to achieve the weight loss, still be employed, and still be maintaining that weight loss over the course of three to five years to see an ROI or some form of savings.
Beckers Hospital Review discusses rural hospitals’ maternity care crisis.
“Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”
“More complete data from a clinical trial of Novo Nordisk’s Wegovy weight loss drug have rekindled the debate over how the treatment will affect patient demand for medical devices and procedures.
“The findings from the SELECT study, presented at a major heart meetingover the weekend, showed a 20% reduction in risk on a composite goal of heart attack, stroke or cardiovascular death, compared to a placebo, in overweight and obese patients with heart disease. But the data were inconclusive on a narrower measure of cardiovascular death alone.
“The data overall confirm a cardiovascular benefit for patients, but mixed results on secondary endpoints do not alter the outlook for heart device makers such as Boston Scientific, Medtronic and Edwards Lifesciences, Mizuho analyst Anthony Petrone said Monday in a report to clients.”
“At first blush, we see the final SELECT data as neutral for cardiovascular names,” he wrote.
“Novartis is deepening its investment in cancer cell therapy, licensing an experimental project developed by Legend Biotech that is in early-stage trials for two types of lung cancer, the smaller company said Monday.
“Novartis will pay Legend $100 million upfront to secure rights to the cell therapy, called LB2102, and could send Legend up to $1 billion more if clinical, regulatory and commercial milestones are met. Legend will complete Phase 1 testing, after which Novartis will assume development responsibilities.
“Legend said Novartis may use in its development plan its new T-Charge manufacturing platform, which aims to reduce the time it takes to make cancer-fighting cells outside the body as well as improve their durability. Cell therapies like Novartis’ Kymriah can induce long-lasting responses in patients, but they require a weeks long manufacturing process that carries the risk of failure or patient progression.”
“House Speaker Mike Johnson (R., La.) unveiled a two-step short-term spending proposal that would keep money flowing to federal agencies into early next year, in a bid to stave off a partial government shutdown late [this] week.
“* * * According to a document obtained by The Wall Street Journal, if the two-step plan doesn’t pass, House Republicans will turn to what they call a full-year continuing resolution, keeping spending flat—although it would contain “appropriate adjustments to meet our national security priorities.” * * *
“The announcement marks a major test for Johnson, who now needs to sell the plan to House Republicans, a group that has been hard to unify on federal spending. Republicans have a 221-212 majority, with Rep. Gabe Amo of Rhode Island, a Democrat, yet to be sworn in after winning an open seat.”
OPM.gov reminds us that the Federal Benefits Open Season begins at midnight November 13. The Open Season ends on December 11, 2023.
A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.
Under the plan from the Biden administration, Medicare would cover patients’ full cost of pre-exposure prophylaxis (PrEP) drugs, which prevent HIV transmission. The drugs would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV.
The FEHBP and other group health plans have been covering PrEP since at least 2020.
“Publishing in the journal Health Affairs, researchers looked at data from the Health Professional Shortage Area (HPSA) program, zeroing in on physician density and mortality. Introduced in 1965, the HPSA program designates areas in need of more physicians and offers bonuses, loan repayment, visa waivers, higher reimbursements and other benefits to doctors who choose to practice and serve Medicare patients in specific communities.
“The researchers analyzed outcomes in HPSAs and areas without the designation between 1978 and 2015, matching 844 shortage counties with similar counties with enough providers. Using a variety of statistical methods designed to sift through dense demographic factors, the analysis yielded few clues that HPSA leads to higher physician numbers or reduces deaths. Some small effects were seen, but the changes were statistically insignificant, the researchers write.”
From the public health and medical/drug research front,
[Novo Nordisk (Novo0] in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%. That finding, which was the primary outcome the trial set out to study, was stronger than many were expecting and led Novo’s stock to surge.
Novo’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardio-vascular trial that affirms the treatment offers health benefits beyond weight loss. * * *
But details of the study, including risk reductions for each specific heart complication, were not released until Saturday when they were presented here — before a standing-room-only crowd — as the first major session of the American Heart Association conference.
The overall 20% risk reduction in heart problems translated to 15 complications prevented for every 1,000 patients treated.
Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.
“For the first time, researchers have produced evidence that gene-editing can cut high cholesterol, a major risk factor for the nation’s leading killer.
“Preliminary results from a study involving ten patients born with a genetic condition that causes very high cholesterol found that editing a gene inside the liver can significantly reduce levels of “bad cholesterol.”
“The experimental treatment needs to be tested on more patients who would be followed for much longer to confirm the approach is safe and effective. But the results are being hailed as a potential landmark proof-of-concept that could eventually provide a powerful new way to prevent heart attacks and strokes.
“A new antibiotic, the first to be developed in decades, can cure gonorrhea infections at least as effectively as the most powerful current treatment, a large clinical trial has found. The drug, zoliflodacin, is taken as a single dose, and it has not yet been approved for use in any country.
“But the drug was developed in a way that experts hope will make it widely accessible and will prevent widespread drug resistance. * * *
“Pharmaceutical companies have largely abandoned antibiotic development as unprofitable. The development of zoliflodacin represents a new model: G.A.R.D.P., which is funded by many Group of 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
“The nonprofit sponsored the Phase 3 trial of the drug. In exchange, it holds the license to sell the antibiotic in about 160 countries, while Innoviva retains marketing rights for high-income countries.
“I’ll go out on a limb and say that’s probably the only way in which we develop antibiotics going forward, because the old model is simply not going to work,” said Ramanan Laxminarayan, a senior research scholar at Princeton University who chairs the G.A.R.D.P. board.”
“To forestall resistance to zoliflodacin, the drug is being developed only as a treatment for gonorrhea and other sexually transmitted infections (STIs). However, it will be up to regulatory and public health agencies to decide when and how the drug can be used.
“New diagnostics will also be important, says Teodora Wi, an STI specialist at the World Health Organization in Geneva. Tests that can rapidly distinguish gonorrhea from other STIs should be more widely available in the near future, but those able to identify drug resistance are further off. National surveillance programs for antibiotic-resistant gonorrhea could also guide the responsible use of zoliflodacin, Wi adds.”
“Weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with diabetes drug Ozempic, often used off label for weight loss—are driving health costs for employers up by more than $300 per insured worker this year, new data from benefits consultancy Aon says.
“These GLP-1 drug costs are expected to boost healthcare spending through 2025, increasing from $324 per insured member this year up to $500 per insured health plan member in two years, new data from the benefits consultancy Aon says. By comparison, annual spending on such prescriptions in 2021 was $96 per member, Aon data shows.
“Employees, too, can expect higher co-payments, deductibles and premiums deducted from their paychecks because employers almost always shift part of their total premium costs onto workers, though this can vary widely depending on employer.
“Aon’s analysis comes from its Aon Rx claims data from nearly 500 employers and their 4.4 million health plan members. Aon said weight loss prescriptions Wegovy, Rybelsus and Saxenda have led the growth, with health spending contributions from Ozempic, which is approved to treat diabetes but is often prescribed off label by physicians for weight loss.”
Big money.
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