Monday Roundup

Medical / Rx research

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Generative AI, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC (note the FEHBlog is back in Texas after a productive week in DC)

  • The Society for Human Resource Management tells us,
    • “The National Labor Relations Board (NLRB) announced it will extend the effective date of its joint employer rule to Feb. 26, 2024, to facilitate resolution of legal challenges to the rule.
    • “The NLRB released the final rule on Oct. 26 with an implementation date of Dec. 26. The rule was published in the Federal Register on Oct. 27.
    • “U.S. Sen. Bill Cassidy, R-La., sent a letter informing the NLRB that it was out of compliance with the Congressional Review Act’s 60-day threshold rule, which mandates that the implementation of all major federal rules must be delayed 60 days from when they are received by Congress.
  • The Internal Revenue Service posted for public comment a draft version of the 2024 Employers’ Tax Guide to Fringe Benefits.

From the public health and medical research front,

  • The Associate Press reports,
    • “The U.S. flu season is underway, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.
    • “The Centers for Disease Control and Prevention posted new flu data on Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month. * * *
    • “Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.”
  • STAT News offers its observations on this development.
    • “The early signals from influenza suggest the virus is settling back into the seasonal pattern it followed — to the degree the always mercurial bug follows any pattern — before the pandemic, said Alicia Budd, team lead for domestic flu surveillance at the Centers for Disease Control and Prevention. “All I can say is at this point we are at a pretty typical point in flu activity,” she told STAT.
    • “Overall, the signs to date appear to portend a winter more like what we knew before the arrival of Covid, said Megan Culler Freeman, an assistant professor of pediatrics specializing in infectious diseases at the University of Pittsburgh.
    • “Last year as early as August, children’s hospitals across the country were full to the gills … because there were so many children with respiratory distress,” Freeman said. “And I would say that this season is starting to feel a lot more normal. Only now, as we’re getting into November — even towards mid- to late- November — we’re starting to see more of our winter volume starting to begin. * * *
    • “The scientific consensus is still out about whether Covid will be a seasonal virus, transmitting primarily during cold-and-flu season. Many experts think it is heading that way, but hasn’t yet settled into that pattern.”
  • The American Medical Association explains what doctors wish their patients knew about diabetes 2. Check it out.
  • KFF informs us,
    • “Research suggests that the Novavax [Covid] vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene. Vaccine uptake has plummeted since the first shots became widely available in 2021. Nearly 70% of people got the primary vaccines, compared with fewer than 20% opting for the mRNA covid boosters released last year. Numbers have dwindled further: As of Oct. 17, only 5% of people in the United States had gotten the latest covid vaccines, according to the Department of Health and Human Services.
    • “Daniel Park, an epidemiologist at George Washington University, said low rates might improve if people who felt lousy after their last mRNA shots gave Novavax a try. It protects against severe illness, but researchers struggle to specify just how effective this and other vaccines are, at this point, because studies have gotten tricky to conduct: New coronavirus variants continuously emerge, and people have fluctuating levels of immunity from previous vaccines and infections.
    • “Still, a recent study in Italy suggests that Novavax is comparable to mRNA vaccines. It remained more than 50% effective at preventing symptomatic covid four months after vaccination. Some data suggests that mixing and matching different types of vaccines confers stronger protection — although other studies have found no benefit. 
    • “Given all this, Park held out for the Novavax vaccine on account of its potentially milder side effects. “Between a demanding full-time job and two young kids at home, I wanted to stay operational,” he said. His arm was sore, but he didn’t have the 24-hour malaise accompanying his last mRNA shot.”

From the U.S. healthcare business front,

  • MedCity News notes,
    • “Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany.
    • “Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio.
    • “Some of Lilly’s capital investments have been closer to the Indianapolis-based drugmaker’s home. Last year, the company committed more than $2 billion to two new facilities in Lebanon, Indiana for the manufacturing of existing products and future ones, the company said in its annual report. Lilly also invested more than $1 billion in a new facility in Concord, North Carolina, for the manufacturing of injectable products and devices. Earlier this year, Lilly pledged to spend an additional $450 million to expand capacity at a site in Research Triangle Park that also makes injectable products, including new blockbuster medicine Mounjaro.”
  • Healthcare Dive points out,
    • “AstraZeneca’s new health-tech business, Evinova, launched Monday, with several big-name partnerships already in place and a goal to “better meet the needs of healthcare professionals, regulators and patients.”
    • “Evinova’s main focus will be helping to optimize their clinical trials for biotechnology companies, pharmaceutical firms and CROs, or contract research organizations, in an effort to reduce the time and costs associated with developing new medicines.
    • “Two CROs, Parexel and Fortrea, have agreed to offer Evinova’s digital health solutions to their customers. Evinova is also collaborating with Accenture and Amazon Web Services to “accelerate industry adoption and sustain and expand the global reach of its digital products.”
  • Per Fierce Healthcare,
    • “The financial outlook for major health plans is stable in the face of notable potential headwinds heading into the end of the year, according to a new report from Moody’s Investors Service.
    • “The Moody’s analysis said earnings in the third quarter were on par with reports from the second quarter and that the industry’s stability is in line with expectations. However, the researchers said they were expecting payers to face different challenges as 2023 got underway.
    • “A notable trend that emerged in the second quarter was increased utilization in Medicare Advantage (MA), which peaked in the second quarter thanks to a boost in outpatient care. While the trend did stabilize in the third quarter, “it did not get better,” the Moody’s analysts wrote.
    • “Centene was the lone exception, and it reported a lower medical loss ratio for MA in the third quarter of 2023 compared to the prior-year quarter, according to the report.”
  • and
    • “As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs.
    • “More than half (53%) of U.S. consumers believe generative AI could improve access issues and shorten wait times for medical care, according to a survey by Deloitte’s Center for Health Solutions. A little less than half of consumers (46%) say it has the potential to make healthcare more affordable.”

Weekend update

David Ermer–Congress, Medical / Rx research, OPM–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • Congress is back home this week to celebrate Thanksgiving. Roll Call has made available a tentative 2024 Congressional calendar.
  • FedSmith reports that the U.S. Office of Personnel Management issued a final 2024 calendar year locality pay rule last week.
    • “For 2024, four new locality pay areas have been established by the final regulations. These are:
      • “Fresno-Madera-Hanford, CA; 
      • “Reno-Fernley, NV; 
      • “Rochester-Batavia-Seneca Falls, NY; and 
      • “Spokane-Spokane Valley-Coeur d’Alene, WA-ID. 
    • “The President will set locality pay rates for these four areas. This usually occurs in late December.”
  • MedPage Today suggests that Medicare coverage of GLP-1 anti-obesity drugs is the key to lower prices. Medicare coverage would benefit FEHB plans with Medicare Part D EGWPs. While Medicare would pay lower prices for these drugs, the FEHBlog doubts that Medicare coverage will help payers without Medicare Part D EGWPs.

From the public health and medical research front,

  • The New York Times states,
    • “Shortly after a baby is born, doctors clamp the umbilical cord linking the infant to the placenta, which is still inside the mother’s uterus, and then cut it. New research shows that if doctors wait at least two minutes after the birth to clamp the cord, they significantly improve in-hospital survival rates for premature infants.
    • “Delayed cord clamping — an intervention that can be introduced at relatively little cost — is believed to help because it allows umbilical cord blood, which is rich in iron, stem cells and antibodies, to flow back to the baby. Some experts say that it’s not entirely clear why the strategy seems to help, but that the data is convincing.”
  • Fortune Well tells us what super-agers can teach us about living longer.
    • “One hundred year-old Maureen Paldo still lives in the same Chicago home that she and her husband purchased when they married after World War II. Paldo, who’s been widowed for about 30 years, says she still manages the stairs, takes walks as often as possible, and loves to have people come to visit. * * *
    • “Paldo is participating in a a large, genetic study of elders, called the SuperAgers Study, to help researchers answer some key questions about life span and health span. It may even lead to a longevity pill that could help more of us live healthier, longer lives.
    • “We still don’t really know why some people live well into their ninth or tenth decades of life with few physical or cognitive problems, while others show decline much sooner. While genetics plays a role, we are still learning about all of protective inherited and natural factors, according to Dr. Sofiya Milman, the study’s chief investigator and Director of Human Longevity Studies at the Institute for Aging Research at Albert Einstein College of Medicine in New York. SuperAgers all seem to have the APoE2 gene variant in common, which protects against Alzheimer’s or dementia, but that’s only a partial explanation.
    • “In one analysis, Milman’s team compared the lifestyle of centenarians to the lifestyle of a general population group from the same birth years. Those in the general population group didn’t live as long, despite similar rates of tobacco and alcohol use, diet, and exercise.
    • “What is it that makes the difference?” she asks. “We know enough to know that this is a very valuable group to study because looking at smaller groups of superagers and centenarians have indicated that there’s definitely heritability for healthy aging and healthy longevity.”

Midweek update

David Ermer–CMS, Congress, FDA, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Washington Post reports,
    • “The Senate passed legislation Wednesday to extend funding for federal agencies, sending the bill to avert a government shutdown to President Biden’s desk just days before the weekend deadline.
    • “The bill, which passed by an 87-11 vote, represents a marked de-escalation between congressional Democrats and new House Speaker Mike Johnson (R-La.). Without the new spending measure, called a continuing resolution or CR, the government would have shut down just after midnight Saturday, forcing federal workers — including military members and airport security agents — to work without pay or go on furlough on the eve of the Thanksgiving holiday.”
  • Roll Call informs us,
    • “House lawmakers left town Wednesday for Thanksgiving after a GOP revolt that led to defeat of the rule for floor debate on the final two pieces of legislation the chamber was scheduled to consider.
    • “Nineteen Republicans voted against the rule for the fiscal 2024 Commerce-Justice-Science spending bill and separate legislation dealing with frozen Iranian assets.
    • “Combined with all Democrats voting “no,” the measure was rejected on a 198-225 vote, leaving the House with no further business to attend to after dispensing with a series of pending amendments to the fiscal 2024 Labor-HHS-Education appropriations bill.”
  • The Department of Health and Human Services announced,
    • “taking the next step in working to ensure greater access to the life-saving services that it provides for people with Limited English Proficiency (LEP) and people with disabilities. In releasing the HHS Language Access Plan, HHS joins agencies across the federal government in prioritizing communication in services to the public. Today’s action supports President Biden’s Executive Orders to advance racial equity and support for underserved communities, which aims to improve access to benefits and services across the Administration, including for people with LEP.”
  • and
    • On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) placed on display at the Federal Registera final rule that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities, commonly known as nursing homes. It also defines the terms private equity company and real estate investment trust, about which information must be disclosed on Form CMS-855A, the Medicare enrollment application. This final rule continues a series of initiatives the Biden-Harris Administration announced in February 2022[1], designed to improve care and accountability at such facilities.
  • Per Govexec,
    • “The U.S. Postal Service lost $6.5 billion in fiscal 2023 despite initial projections it would break even for the year, and leadership cautioned the agency will once again be in the red in fiscal 2024. 
    • “Looking at only the parts of the operation that USPS leadership considers within its control, losses spiked to $2.3 billion compared to just $500 million in fiscal 2022 and a controllable profit of $1.5 billion in fiscal 2021. At the start of fiscal 2023, USPS forecasted a $4 billion loss. The negative financial numbers occurred despite the Postal Service growing its total revenue by $500 million. 
    • “Postal leadership attributed much of the losses—about $5.6 billion—to two factors: ongoing inflation and a miscalculation of what it must statutorily contribute toward its pension fund. Postmaster General Louis DeJoy also noted USPS is incurring upfront costs as it updates its network as part of his 10-year Delivering for America plan.” 
  • The Food and Drug Administration announced,
    • granting marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. Prior to today’s authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office. The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.

In Open Season news, Reg Jones discusses the FEDVIP and FSAFeds offerings in Fedweek.

From the public health and medical research front,

  • STAT News reports from London,
    • Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world.
    • A study published Wednesday backs up the idea that they can. Researchers behind the work relied on novel statistical approaches to analyze millions of records from England’s National Health Service and found that participants in the NHS’s Diabetes Prevention Program saw improvements in risk factors for type 2 diabetes, indicating that patients can benefit from such initiatives even outside the confines of a controlled experiment.
  • The Washington Post points out,
    • “Lung cancer survival rates have increased over the past five years, but serious disparities remain among Black and Latino communities, according to the American Lung Association’s 2023 “State of Lung Cancer” report released Tuesday.
    • “The report highlights the need for better messaging about screening for lung cancer, which is still the nation’s leading cause of cancer-related deaths. The disease claims more than 120,000 lives each year, according to the American Cancer Society, in part because it is most often diagnosed at later stages when the cancer is harder to treat.
    • “The national survival rate for lung cancer jumped nearly five percentage points, from 21.7 to 26.6 percent, over the last five years, said report author Zach Jump, the national senior director of epidemiology, statistics and research at the American Lung Association.”
  • KFF lets us know,
    • “The U.S. spends huge amounts of money on health care that does little or nothing to help patients, and may even harm them. In Colorado, a new analysis shows that the number of tests and treatments conducted for which the risks and costs exceed the benefits has barely budged despite a decade-long attempt to tamp down on such care.
    • “The state — including the government, insurers, and patients themselves — spent $134 million last year on what is called low-value care, according to the report by the Center for Improving Value in Health Care, a Denver nonprofit that collects billing data from health plans across Colorado. The top low-value items in terms of spending in each of the past three years were prescriptions for opiates, prescriptions for multiple antipsychotics, and screenings for vitamin D deficiency, according to the analysis.”
  • McKinsey and Company discusses how
    • “Clinical factors are responsible for just 20 percent of individuals’ health outcomes; the remainder can be attributed to factors such as health-related social needs (HRSNs).1 Increasing recognition of the impact of these needs on consumers’ health and livelihoods is driving momentum across the healthcare ecosystem to integrate health and social care, creating opportunities for healthcare entities to design consumer-centric models of care tailored to individual needs and preferences.
    • This article synthesizes insights gleaned from a survey of more than 5,000 US consumers that highlights how HRSNs are evolving; their potential impact on healthcare use, preferences, and outcomes; and actions healthcare entities may consider to effectively support consumers’ needs.”
  • The Wall Street Journal reports,
    • “Researchers are coming up with new ways to make medical studies less white.
    • “They are building trust in groups long ignored by science and working with doctors and patients of color to design better studies. They are opening research sites in more diverse communities and providing stipends to help people participating in their studies pay for gas and child care.
    • “The efforts are starting to work: More people of color are participating in medical research. That is good news for everyone. Data from clinical trials—used to approve drugs and train artificial intelligence on medical decision-making—until recently failed to include swaths of the population. In the future, more diverse data sets will lead to better treatments and prevention of diseases in people of different backgrounds.
    • “Without diversity, we lose the ability to address fundamental problems that lead to suffering and loss of life,” said Dr. Carol Horowitz, director of Mount Sinai’s Institute for Health Equity Research.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Amazon’s One Medical inked a major partnership with Health Transformation Alliance, expanding access to its primary care services to 67 employers and nearly 5 million employees.
    • “HTA is a collective of large U.S. employers, and its member companies include Coca-Cola, American Express, Marriott, Boeing and Intel.
    • “Employers are grappling with rising healthcare costs and expect health benefit expenses to climb 5.4% in 2024, according to Mercer.
    • “HTA, on behalf of its member companies, saw an opportunity to partner with One Medical to provide access to high-quality primary care services while also addressing inefficiencies and costs in the healthcare system, according to HTA CEO Robert Andrews.”
  • BioPharma Dive reports,
    • “Gilead is expanding its collaboration with cancer cell therapy developer Arcellx, announcing Wednesday that subsidiary Kite Pharma has used an option to license a second experimental drug. The partners will also broaden their collaboration on a cell therapy that was the subject of the initial partnership.
    • “Per deal terms, Gilead will buy $200 million of Arcellx shares, giving it a 13% stake, as well as pay an $85 million cash fee. Arcellx will be owed undisclosed payments on achievement of development milestones “to offset prespecified development costs,” according to Gilead.
    • “Last year, Gilead paid $225 million upfront and made a $100 million investment in Arcellx to secure access to the first drug in the collaboration, a type of cancer treatment called CAR-T therapy, which engineers a patient’s own immune cells to attack tumors.”
  • Health Payer Intelligence notes,
    • “Members with diabetes spend between $3,300 and $4,600 per year in out-of-pocket costs for chronic disease management, including lost wages, according to a new report from GoodRx Health.
    • “These out-of-pocket cost estimates accounted for health insurance coverage but still represented 6 to 8 percent of the typical yearly wage in the US.
    • “The researchers addressed the cost of managing diabetes separately from the cost of complications. They used data from the Medical Expenditure Panel Survey (MEPS) for 2021 and prices across online diabetes medical device suppliers to assess healthcare spending among patients with diabetes.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The House passed legislation on Tuesday to keep federal funding flowing into early 2024, after Democrats stepped in to rescue a plan opposed by many Republicans to avert a government shutdown at the end of the week.
    • “A coalition of Democrats and mainstream Republicans overcame the opposition of G.O.P. conservatives to approve the bill under special expedited procedures that required a supermajority. That approach, hatched by Speaker Mike Johnson, amounted to a gamble that a substantial number of Democrats would rally to help pass a package that Mr. Johnson’s own party was unwilling to back.
    • “The vote was 336 to 95, clearing the two-thirds threshold required for passage. In the end, 209 Democrats and 127 Republicans joined to pass the bill. Ninety-three Republicans opposed it, as did two Democrats.
    • “Senator Chuck Schumer of New York, the majority leader, told reporters that he wanted the Senate to vote on the bill “as soon as possible.”
  • The American Academy of Pediatrics News announced,
    • “The advisory was issued after the Food and Drug Administration (FDA) received 22 reports of high blood lead levels (BLLs) in children who consumed recalled fruit pouches that contain high levels of lead. The recall includes WanaBana brand apple cinnamon fruit puree pouches, Schnucks brand cinnamon applesauce pouches and Weis brand cinnamon applesauce pouches.”
  • ICD Monitor points out that “the new Healthcare Common Procedural Coding System (HCPCS) codes were released on Nov. 6. These codes include supplies, medications, implants, surgeries, etc. The latest release contained 553 changes and updates to the coding system . . . .
  • The Acting NIH Director Lawrence Tabak released his farewell issue of the NIH Directors blog.
    • “I congratulate Dr. Monica Bertagnolli as she takes the helm as the next permanent NIH director. Dr. Bertagnolli—an outstanding physician scientist—is a strong leader who will bring fresh, bold new ideas to NIH and the biomedical research enterprise. I know she’ll be in good hands thanks to the outstanding staff across NIH and the leadership in the Department of Health and Human Services. I look forward to supporting her efforts and continuing to ensure that NIH research optimizes health for all people.”

From the public health and medical research front,

  • MedPage Today informs us that early detection is the key to longer survival rates for people afflicted with pancreatic cancer.
  • NPR tells us,
    • “If your hearing begins to decline, your risk of falling may rise.
    • “Research shows older adults with mild hearing loss are at a greater risk — more than double — of falling. Though it’s not exactly clear how hearing loss increases the risk, it’s known that falls are the top cause of death from injury among people 65 and older.
    • “Now, new evidence shows that restoring hearing through the use of hearing aids may be protective, especially when people wear them consistently. That’s according to a study published this summer in the Journal of the American Geriatrics Society.”
  • The Wall Street Journal reports,
    • “Millions of adults struggle for years with chronic low-back pain—a disabling ailment that has no easy fix.
    • “Common causes include injury, arthritis and degenerative changes in the spine. It tends to start at midlife with the natural wear and tear of aging. But often there is no clearly identifiable physical cause, leaving patients to veer from one ineffective treatment to another—including highly addictive prescription opioids.
    • “Now, researchers are working on personalized treatment plans that can address physical, emotional and psychological traits in individual patients that influence the pain they are experiencing. Physical therapy, exercise, diet and lifestyle choices often play a role. Some research is also looking at ways to retrain the brain to think differently about pain.
    • “To be sure, low-back pain can be a sign of something life-threatening, such as cancer, or a severe spine condition that requires surgery. As a result, chronic low-back pain needs to be fully evaluated. But once “red flags” are eliminated, doctors need a more precise way to determine what will work for individual patients, says Dr. Matt Mauck, a researcher and pain-medicine physician at the University of North Carolina Chapel Hill’s UNC Pain Management Center.”
  • The Institute for Clinical and Economic Review “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension (PAH).”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 1, 2023. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans announced,
    • “A new survey report from the International Foundation of Employee Benefit Plans reveals U.S. employer coverage and considerations surrounding glucagon-like peptide-1 (GLP-1) drugs, which have historically been used to treat diabetes. These drugs were also found to cause weight loss and have been subsequently used to treat obesity.
    • “Among survey respondents, 76% provide GLP-1 drug coverage for diabetes, 27% provide coverage for weight loss, and 13% are considering covering for weight loss.
    • “In 2023, the average representation of GLP-1 drugs used for weight loss in employers’ total annual claims was 6.9%, according to survey respondents. Those who are covering GLP-1 drugs are relying heavily on utilization management (79%) to control costs. A less common approach (32%) is step therapy. Fourteen percent of employers have no cost control mechanism in place.
    • “Though GLP-1 drugs have a high price tag, they currently represent only 6.9% of annual claims, according to survey respondents,” said Julie Stich, CEBS, Vice President of Content at the International Foundation. “Employers can take this information into account when designing long-and short-term benefit strategies.”
  • Bloomberg reports,
    • “Cigna Group is taking a page from billionaire Mark Cuban’s playbook to sell medicines for a set markup, the latest sign that companies that manage drug benefits are responding to pressure from upstart competitors.
    • “Next year Cigna’s Express Scripts subsidiary will offer employers and health plans the option to pay pharmacies up to 15% above their wholesale costs, plus an extra fee for dispensing the medicines. Employers now typically pay pharmacies based on an average discount, which can result in them paying more for drugs than a pharmacy charges.”
  • Reuters notes,
    • “Elevance Health (ELV.N) and Cigna Group’s (CI.N) Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Elevance to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.”
  • The Albany Times-Union reports that Empire Blue Cross is changing its name to Anthem Blue Cross.
    • “The company retains the Blue Cross Blue Shield name and remains part of the Blue Cross Blue Shield Association, which serves one in three insured Americans. * * *
    • “Empire joined Anthem in 2006, and the new name represents the next stage in the company’s journey to merge with the national brand, benefiting from combined resources and capabilities of its parent company and affiliates, company executives said.”
  • Per Fierce Healthcare,
    • “BeMe, a digital behavioral health app aimed at teenagers, has inked several partnerships with major payers, including $1.5 million in investment from Blue Cross and Blue Shield of Kansas (BCBSKS).
    • “Through the investment, BeMe’s platform will be made available to 20,000 teenagers across the Sunflower State. Executives said in an announcement that tools like BeMe will become increasingly critical as youth mental health issues continue to worsen.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The FEHBlog is back in DC for the workweek. So let’s get started with news from the Washington, DC, front,

  • The continuing resolution funding the federal government expires on Friday, November 17.
  • The Wall Street Journal reports,
    • “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.
  • MedPage Today notes,
    • 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.
  • The Washington Post informs us,
    • “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,

  • STAT News tells us,
    • [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%.
  • Per NPR Shots,
    • “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.
  • The New York Times reports,
    • “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.”
  • Nature adds,
    • “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.”

From the U.S. healthcare business front,

  • Forbes reports,
    • “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.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Republicans yanked another fiscal 2024 spending bill before a final vote scheduled for Thursday morning, leaving them empty-handed for the week and stuck at seven out of 12 annual appropriations bills passed.
    • “The $25 billion Financial Services bill [which funds OPM and the FEHBP] ran into trouble with GOP moderates over language that would block the District of Columbia from implementing its 2014 law preventing employment discrimination based on reproductive health decisions, including taking birth control or having an abortion.
    • “The simple analogy is they didn’t have the votes. Shocking,” said Rep. Ryan Zinke, R-Mont., who backs the bill. “Monday, we’ll see if we can have a consensus over the weekend for those people that have a problem with what I think is a very straightforward bill.”
    • “Another issue which contributed to the measure’s demise Thursday, according to a source familiar with the decision, was conservative opposition to allowing the General Services Administration to implement its plan to build a new FBI headquarters in Greenbelt, Md.”
  • As Rosanna Rosannadana would say, “If it’s not one thing, it’s another.”
  • The Society for Human Resource Management informs us,
    • “Employees can funnel an extra $150 into their health flexible spending accounts (FSAs) next year, the IRS announced Nov. 9.
    • “The annual contribution limit is rising to $3,200 in 2024, up from $3,050 in 2023. The hike is still significant, although it’s a smaller boost than the $200 hike seen this year.
    • “If the employer’s plan permits the carryover of unused health FSA amounts, employees can carry over up to $640 in 2024. That’s up $30 over the 2023 carryover amount, which is $610.”
  • Here’s a link to the IRS’s complete list of 2024 inflation adjustments to tax items.
  • STAT News tells us that the Ground Ambulance Committee created by the No Surprises Act wants to cap the cost-sharing for people who use ground ambulances at $100 per trip. The catch is that they have difficulty deciding how much health plans should pay for ground ambulance services.
    • “Some experts say a Medicare benchmark is the simplest administrative solution. Medicare’s payment system for ambulances is outdated, but it’s based on some measure of costs. But that shift would result in a lot of upheaval, especially for ambulance providers that currently are able to bill and collect large sums of money from the biggest insurance companies. * * *
    • “Early next year, the federal ambulance committee will deliver its recommendations to Congress. Key lawmakers have not shown a lot of interest in taking up surprise billing again because it requires a lot of political capital to confront the ambulance and insurance industries.”

In FEHBP news,

  • FedSmith offers its strategy for approaching the FEHB open season which begins next Monday.
  • FedWeek discusses coordinating benefits between FEHB plans and Medicare. The best resource is OPM’s chart found in Section 9 of every FEHB plan’s brochure.

From the public health and research front,

  • The Wall Street Journal reports,
    • “A team of New York surgeons has performed the world’s first whole-eye transplant on a human, a breakthrough that could change vision treatments even though the patient hasn’t regained sight in the grafted eye. 
    • “In the six months since the eye surgery was performed, in conjunction with a partial face transplant, the 46-year-old patient has shown promising signs of health in the eye, the surgical team at NYU Langone Health said Thursday. 
    • “The grafted eye is maintaining normal ocular pressure and has direct blood flow to the retina, the area at the back of the eye that receives light and sends images to the brain. It isn’t known if the patient will regain his sight, but the transplant is still a significant accomplishment, according to Dr. Eduardo D. Rodriguez, director of the Face Transplant Program at NYU Langone.  
    • “We’ve made one major step forward and have paved the way for the next chapter to restore vision,” Rodriguez said. Rodriguez led the May surgery, which lasted 21 hours and included more than 140 surgeons, nurses and other healthcare professionals.” 
  • The Food and Drug Administration announced,
    • “approving Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.”
  • and
    • “approving Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
    • “The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.” 
  • and
    • clearing for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
  • Per Beckers Hospital Review,
    • “Pneumonia patients who took an antibiotic that’s typically reserved as an alternative were less likely to develop Clostridioides difficile infections compared to those taking the recommended drug, according to a study from Veterans Affairs Hospitals. 
    • “The retrospective study analyzed 156,107 patients treated for pneumonia at a VA hospital between 2009 and 2022. Overall, less than 1% of pneumonia patients were diagnosed with a C. diff infection, but among those who had C. diff in the year before contracting pneumonia, 12% developed a new C. diff infection associated with their antibiotic treatment. 
    • “Clinical guidelines recommend azithromycin, and nearly 9 in 10 of the patient cohort received the drug. Of the 13% who received doxycycline, the alternative antibiotic, the drug was associated with reducing C. diff infections by 45%. 
    • “The researchers concluded that, if Legionella pneumonia can be ruled out, clinicians might consider doxycycline as a first-line treatment over azithromycin.”
  • The Wall Street Journal notes,
    • “There is hope for those of us who live (and sleep) in the real world: Getting less than 8 hours of shut-eye a night doesn’t mean you’re doomed to an early grave.
    • “A recent study looking at sleep and longevity found that sleep “regularity”—going to bed and waking up at consistent times with few mid-slumber interruptions—matters more than how long you sleep. Sleeping six hours every night on a consistent schedule was associated with a lower risk of early death than sleeping eight hours with very irregular habits.
    • “The study adds to a growing understanding of the links between sleep and longevity. Research in recent years has shown not only how important sleep is for health and lifespan, but also that the duration of sleep isn’t the only thing that matters.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “For-profit hospital operators strained by physician fees, payer relations in the third quarter of 2023. Except for HCA, the biggest U.S. health systems all reported lower year-over-year profits in the third quarter.”
  • and
    • “More than 85,000 Kaiser Permanente healthcare workers have a new four-year contract with the nonprofit system after union members overwhelmingly voted to ratify a compromise reached in October following months of labor negotiations and a high-profile strike.”
  • and
    • “Virgin Pulse announced on Thursday it closed its merger with third-party health plan administrator HealthComp. Private equity firms New Mountain Capital and Marlin Equity Partners are new majority and minority owners of the company, respectively, according to a release.”
  • Per Fierce Healthcare,
    • “Optum Rx is shifting eight different insulin products to its preferred formulary in a bid to address affordability, the company said Thursday.
    • “The product selection includes all rapid-acting and short-acting insulin products and some long-acting insulins, according to the announcement. It includes insulins manufactured by Sanofi, Novo Nordisk and Eli Lilly.
    • “Optum’s Tier 1 includes the lowest cash prices that its members will pay, the company said.”
  • and
    • A BCBSA study concludes that the Affordable Care Act’s risk adjustment system works, notwithstanding noteworthy failures.
  • The Wall Street Journal reports,
    • “AstraZeneca raised its full-year guidance for core earnings per share and total revenue excluding Covid-19 medicines despite a lower third-quarter profit that missed forecasts after booking a tax charge compared with a credit for the comparable period.
    • “The Anglo-Swedish pharmaceutical giant said Thursday that it expects core earnings per share to increase by a low double-digit percentage compared with previous guidance of a high single-digit to low double-digit percentage increase.
    • “Total revenue excluding COVID-19 medicines is now expected to increase by a low-teens percentage at constant-exchange rates compared with previous expectations of low double-digit percentage growth.
    • “Total revenue is expected to increase by a mid-single-digit percentage compared with previous guidance of low-to-mid single-digit, it said.”

Midweek Update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today lauded committee passage of the Better Mental Health Care, Lower Drug Cost, and Extenders Act, which was reported out of committee 26-0.” 
  • “The legislation expands mental health care and substance use disorder services under Medicaid and Medicare, reduces prescription drug costs for seniors at the pharmacy counter, extends essential Medicaid and Medicare provisions that will expire this year, and increases Medicare payments to support physicians and other providers. * * *
  • “Click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • Fierce Healthcare adds,
    • “Under the Senate Finance proposal, the $8 billion in cuts to hospitals through the Medicaid disproportionate share hospital (DSH) payments will be eliminated, saving providers $16 billion over the next two years, according to the mark released earlier this week.
    • “Hopefully in further discussion Senators will decide not to pursue so-called ‘site neutral’ policies,” said Federation of American Hospitals President and CEO Chip Kahn in a statement. “This is no time for hospital cuts – particularly for struggling hospitals serving rural America. This ‘one-size-fits-all’ policy will ultimately threaten service resulting in limits on access to care for seniors and others who are better served receiving necessary treatment in the hospital. “
    • “The draft also includes decreasing physician reimbursements by 1.25%, a reduction from larger cuts that could better appease physician interest groups.”
  • STAT News reports
    • “Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes [and nicknamed the Godzilla of GLP-1 drugs], has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
    • “The Food and Drug Administration’s long-awaited approval of the injectable drug, which will be marketed under the name Zepbound for obesity, is a milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages. * * *
    • “Lilly will sell Zepbound at a list price of $1,059.87 per month, about the same price as Mounjaro and about 20% lower than the price of Novo’s Wegovy. Lilly is also introducing a savings card program for people with commercial insurance.
    • “Lilly expects the drug to be available in American pharmacies after Thanksgiving. In an effort to prevent future shortages, the company plans to have roughly doubled its manufacturing capacity by the end of the year, CEO David Ricks said on a conference call with reporters. Only about 5 million people in the U.S. receive any form of GLP-1 treatment, Ricks said, but there are roughly 50 million Americans who would be eligible for Zepbound and who have commercial insurance that covers obesity treatments.
    • “We know with such an effective medication there’ll be a lot of demand,” Ricks said. “We’re stepping up to that challenge and hope to fulfill it in the coming years.”
  • Ka-ching!!
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC) today released three reports focusing on different groups of women in the federal government: American Indian and Alaska Native (AIAN) women, African American women, and Hispanic women and Latinas.
    • “The reports examined fiscal year (FY) 2020 data to compare the participation, retention, advancement, and pay of each group of women to three different groups: the total federal workforce, all women, and men of the same ethnicity or race. Results show that employment outcomes for these three groups of women were not equal to the comparison groups. Understanding the challenges these groups of women face in the federal workplace can help agencies better address these inequalities.”

From the public health and research front,

  • The Wall Street Journal reports that children in mental health crises have been surging into hospital emergency rooms.
    • “Broadly, children’s demand for emergency mental-health services has eased from the pandemic’s extreme highs, according to an analysis of records across more than 1,100 hospitals by the research arm of Epic Systems, a medical record software company. Still, the rates remain elevated. 
    • “For adults, the data on trips to emergency departments for psychiatric reasons during the pandemic is limited, but doctors say they are more used to seeing such cases. E.R.s aren’t accustomed to seeing large numbers of children in psychiatric crisis—and many are ill-equipped to handle them.”
  • STAT News reports,
    • “The radiopharmaceutical world is now approaching critical mass. There are currently around 75 such startups in the U.S., several of which have raised sizable financing rounds this year. In September, RayzeBio managed to complete an IPO — rare amid an industry slump — raising $358 million. Bayer has made a few acquisitions in the field. And last month, pharmaceutical giant Eli Lilly jumped in, acquiring Point Biopharma and its Phase 3 radiopharmaceutical treatment for prostate cancer for $1.4 billion.
    • “Investors and executives are optimistic these investments will pay off not just for venture capitalists, but for cancer patients. But just how much they can benefit the field remains to be seen. To achieve anything, radiopharmaceutical companies must hurriedly address supply and production challenges — issues that have handicapped other promising areas of oncology drug development.”
  • and
    • Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published Wednesday in Cell Host & Microbe.
  • and
    • “In American health care, overtreatment is common. Recently though, there has been a subtle shift in the opposite direction. It’s possible that “less is more” is catching on.
    • “Now, some providers are asking what the line between necessary and unnecessary really is. The results are encouraging, suggesting that, in some cases, it may be possible to achieve the same health outcomes with less treatment — and fewer side effects, too.
    • “This shift is particularly noticeable in cancer care.”
  • Here is a link to the National Cancer Institute’s latest research update.
  • Gallup announced
    • “U.S. workers are optimistic that employer-sponsored wellness initiatives could enhance their wellbeing, according to data from the Bentley-Gallup Business in Society Report. When asked to rate the potential impact of six wellness initiatives on wellbeing, the top three most positively rated (based on combined extremely and somewhat positive ratings) are employers offering a four-day workweek option (77%), providing mental health days (74%) and limiting the amount of work employees are expected to perform outside of work hours (73%).”
  • Becker’s Payer Issues tells us,
    • “Increasing Medicare Advantage enrollment in rural areas did not increase rural hospitals’ financial distress or risk of closing, a study published Nov. 3 in the American Journal of Managed Care found. 
    • “Researchers studied rural hospitals in 14 states from 2008 to 2019. Medicare Advantage enrollment in rural hospital counties increased from 14.3% of Medicare beneficiaries in 2008 to 28.4% in 2019. The percentage of Medicare inpatient stays paid for by MA plans increased from 6.5% in 2008 to 20.6% in 2019. 
    • “The researchers found that when Medicare Advantage penetration increased by 1% in a county, hospitals’ financial stability increased slightly, and they experienced a 5% reduction in risk of closing. 
    • “One in 5 of the hospitals studied treated no Medicare Advantage patients during the study period.” 

From the U.S. healthcare business front,

  • The Segal Company highlights fraud, waste, and abuse trends in this fourth quarter of 2023.
  • Healthcare Dive provides the biggest takeaways from health insurers’ third-quarter earnings.
  • KFF offers
    • “One new analysis shows that the typical beneficiary has a choice of 43 Medicare Advantage plans as an alternative to traditional Medicare for 2024. That is the same number available as in 2023, but more than double the number of plans offered in 2018, which shows how this market is attractive to both enrollees and insurers.
    • “In addition, the typical person covered under traditional Medicare can choose among 21 Medicare stand-alone prescription drug plans (PDPs), the second analysis shows. The number of PDP options for 2024 is lower and the number of Medicare Advantage prescription drug plan (MA-PD) options is higher than in any other year since Part D started, reflecting the broader trend toward Medicare Advantage.”
  • Fierce Healthcare informs us,
    • “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
    • “The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of the patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.
    • “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.”
  • and
    • “Building on its One Medical deal, Amazon is now offering a One Medical for Prime membership, including 24/7 virtual care, for $9 per month, or $99 a year. That’s $100 less than the standard One Medical membership fee, according to the company.
    • “Prime members can add up to five additional memberships, each for just $6 a month, or $66 annually.
    • “The One Medical for Prime membership fee covers unlimited access to 24/7 virtual care nationwide, including video chats with licensed providers and access to an in-app “Treat Me Now” feature that lets users get fast care for common concerns like cold and flu, skin issues, allergies, urinary tract infections.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “House Republicans are aiming to reach a consensus this week on a stopgap funding measure that would get a vote next week before the current continuing resolution runs out on Nov. 17.
    • “During a Monday night leadership meeting, Speaker Mike Johnson, R-La., floated a “laddered CR” that would extend funding for four bills through Dec. 7 and the rest through Jan. 19. Johnson said Tuesday after meeting with the GOP conference that a stopgap bill running into January “with certain stipulations” is also on the table.
    • “The new speaker said he would be revealing his spending plan “in short order” but did not share any details Tuesday morning after House Republicans met to discuss the options. However, Senate Democrats are pushing for a stopgap measure into early December, with Dec. 8 as the preferred end date, according to sources familiar with the consideration.”
  • The Washington Post reports,
    • “The Senate on Tuesday voted 62 to 36 to confirm cancer surgeon Monica M. Bertagnolli as the director of the National Institutes of Health, ensuring that America’s flagship biomedical agency will have a permanent leader following a months-long dispute involving a key senator that threatened to derail her nomination.
    • “Bertagnolli will be the second woman ever to lead the nearly $48 billion agency, which plays a central role in the U.S. scientific agenda by funding grants to hundreds of thousands of researchers, overseeing clinical trials on its Maryland campus and supporting other endeavors to develop drugs and therapeutics.”
  • The U.S. Preventive Services Task Force gave brand new “inconclusive” recommendations to the following services:
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries or periodontal-related disease, in adults.
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries, in children and adolescents aged 5 to 17 years.
  • Federal News Network points out,
    • “In October, 6,924 new [federal and postal retirement] claims were filed, an increase of 156 more than September. OPM also processed fewer retirement claims last month. The agency said it processed 6,098 claims, a  2,781 drop from the previous month.
    • “Initial retirement cases in October completed in less than 60 days on average took 42 days to process, up 2 days from the previous month, while initial cases that were processed in more than 60 days on average took 113 days.  That’s a 9 day improvement from September.
    • “Along with the increase of the claims backlog, the monthly average processing time in days grew from 70 to 73. But there is some good news: The fiscal year-to-date average processing time in days decreased from 77 to 73 days in October.”

In FEHBP news,

  • Per the Federal Times,
    • “Millions of federal employees and their family members will be able to shop for health benefits beginning Monday. 
    • “Open enrollment, spanning for four weeks, could overlap with a government shutdown if Congress fails to extend the current continuing resolution or pass a spending package by next Friday. More than a month into fiscal 2024, the government is still operating on last year’s funding levels after Congress passed a last-minute stopgap bill on Sept. 30.
    • “As the name implies, a shutdown means that many agency offices close and employees whose work is outside of national security, health and “life or death” services are sent home without pay. However, the office that oversees the Federal Employee Health Benefits program and open season is funded by a trust that does not rely on annual appropriations.
    • “There are sufficient amounts in these trust funds to operate them throughout the duration of any lapse in appropriations,” according to the White House’s Office of Personnel Management.
    • “Thus, employees will be able to participate in open season in the event of a shutdown. And coverage will not lapse during this time either, either for medical or dental and vision.”
  • Federal News Network considers, in consultation with Kevin Moss from Consumers’ Checkbook, “six reasons feds why should take a look [at available FEHB plans] during Open Season this year.”

From the public health and research front,

  • The American Hospital Association News tells us,
    • “Over 3,700 babies were born with syphilis in 2022, 32% more than in 2021 and 10 times more than in 2012, the Centers for Disease Control and Prevention reported Nov. 7. Almost 9 in 10 cases last year could have been prevented with timely testing and adequate treatment, the agency said, and urged emergency departments, syringe service programs, prisons/jails and maternal and child health programs to use rapid syphilis testing and treatment during pregnancy and other settings to consider immediate treatment if a patient tests positive and faces obstacles to ongoing care.
    • “The congenital syphilis crisis in the United States has skyrocketed at a heartbreaking rate,” said CDC Chief Medical Officer Debra Houry, M.D. “New actions are needed to prevent more family tragedies. We’re calling on healthcare providers, public health systems, and communities to take additional steps to connect mothers and babies with the care they need.” 
  • The National Institutes of Health announced,
    • “In a small study, researchers at the National Institutes of Health have found that positron emission tomography (PET) scans of the heart may identify people who will go on to develop Parkinson’s disease or Lewy body dementia among those at-risk for these diseases. The findings, published in the Journal of Clinical Investigation and led by scientists at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH, may advance efforts to detect the earliest changes that years later lead to Parkinson’s disease and Lewy body dementia.
    • “In 34 people with Parkinson’s disease risk factors, researchers conducted PET scans of the heart to gain insight into levels of the neurotransmitter norepinephrine. They found that the scans could distinguish individuals who would later be diagnosed with Parkinson’s or Lewy body dementia—both are brain diseases caused by abnormal deposits of the protein alpha-synuclein that form clumps known as Lewy bodies. The research was conducted at the NIH Clinical Center, currently the only location for F-dopamine PET scanning.”
  • The Wall Street Journal reports on ways to control sugar consumption
    • People assume they can build up the willpower to completely avoid sweets or restrict them to tiny amounts, but cutting them out increases the chances of overeating later, says Dr. Judson Brewer, a neuroscientist and psychiatrist at Brown University and author of a forthcoming book about eating habits. 
    • “Willpower is more myth than muscle,” says Brewer.
    • “Unsurprisingly, a fully permissive approach to sugar won’t work for kids, says Crystal Karges, a San Diego-based dietitian who works with families. Still, she doesn’t encourage restriction. One strategy she suggests is to offer sweets alongside regular meals in order to normalize the treats. 
    • “Brewer, the neuroscientist, suggests another alternative to restricting yourself: Find your “pleasure plateau.” Rather than cutting out treats entirely, train yourself to pay close attention to how a treat is tasting as you eat it and note when you stop enjoying the taste of it. 
    • “Practicing attentive eating or mindfulness over time can help your body feel the rewards of limiting sugar consumption, which can be anything from having more energy to fewer cravings to weight loss, Brewer says. 
    • “Keeping your home well-stocked with healthy snacks, alongside indulgent treats, is helpful. In her own home, [University of Minnesota professor Dianne] Neumark-Sztainer says roughly 70% of the food options are nutritious and lack added sugar, including whole grains, fruits and vegetables. 
    • “She doesn’t recommend most people count the amount of sugar they eat each day, which can increase anxiety. “Try to look at the whole picture and not to make a big deal about it,” she says.”

From the U.S. healthcare business front,

  • Per STAT News,
    • “Sage Therapeutics set the price of Zurzuvae, its recently approved treatment for postpartum depression, at $15,900 for a 14-day course of therapy. The once-daily pill will be launched in December, co-marketed with Biogen. 
    • “Eisai reported sales of 300 million yen ($2 million) for Leqembi, its treatment for Alzheimer’s disease, in the company’s fiscal second quarter. Approximately 800 people were receiving treatment with Leqembi as of Oct. 27, the company said.” 
  • Beckers Payer Issues ranks the major health insurers by third-quarter medical loss ratios.
  • Per Healthcare Dive,
    • “E-prescribing giant Surescripts has acquired ActiveRADAR, a company that aims to find cheaper medication alternatives.
    • “ActiveRADAR, formerly known as RxTE Health, evaluates drugs in 165 therapeutic categories to identify clinical equivalents, then uses health plan-specific data to determine alternative medications that could reduce costs for employers and patients, according to the company.
    • “The deal, announced on Monday, makes ActiveRADAR a wholly owned subsidiary of Surescripts, according to a company spokesperson. Terms of the deal weren’t disclosed.”
  • Forbes offers “Five considerations for health plan leaders using AI-enabled prior authorization and utilization management.”

Monday Roundup

David Ermer–CMS, Congress, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg reports,
    • “House lawmakers worked over the weekend on a stopgap measure needed to fund the US government beyond a Nov. 17 deadline, Speaker Mike Johnson said.
    • “While Johnson didn’t mention the proposed length of the extension in a Fox News Sunday interview, he has floated a Jan. 15 timeline since being elected speaker in October.
    • “The extension “would allow us time” to continue the appropriations process, which involves bringing 12 spending bills to the House floor for passage, the Louisiana Republican said.”
  • The FEHBlog watched the House Rules Committee pass a rule on the financial services and general government appropriations bill (HR 4664), which means that the bill will be brought to the House floor this week.
  • From the other side of Capitol Hill,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released the Chairman’s Mark of a legislative package to expand mental health care and substance use disorder services under Medicaid and Medicare, reduce prescription drug costs for seniors at the pharmacy counter, extend essential Medicaid and Medicare provisions that will expire this year, and increase Medicare payments to support physicians and other providers.
    • “The Committee will hold a markup on the legislation on Wednesday, November 8, at 10 a.m.
    • “The Chairman’s Mark can be found here. A section by section can be found here. A CBO analysis can be found here.
    • “Amendments and additional information will be posted here on Tuesday, November 7, after 12 p.m.”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) released governmentwide results of the 2023 OPM Federal Employee Viewpoint Survey (FEVS) today. The OPM FEVS is the largest annual survey of government employees in the world that tracks how federal employees view their current work environment, including workforce management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that collects employee feedback from more than 80 executive agencies to assist in driving improvement and supporting the workforce to serve the American people.   
    • “This year’s Federal Employee Viewpoint Survey highlights that federal employees remain remarkably resilient, increasingly engaged, and value diversity, equity, inclusion, and accessibility in the workplace,” said Kiran Ahuja, Director of the Office of Personnel Management. “These encouraging results provide opportunities for agencies to build momentum and support their workforce to leverage workplace flexibilities, continue advancing DEIA, and remain motivated to continue delivering for the American people.”  
  • The Centers for Medicare and Medicaid Services proposed a new Medicare Advantage Program rule that covers multiple topics.
  • Health Payer Intelligence adds,
    • “Medicare Advantage beneficiaries experience higher quality care and better health outcomes than fee-for-service beneficiaries, according to a report from Harvard and Inovalon.
    • “Researchers used Inovalon’s claims data to assess care quality for people enrolled in Medicare Advantage and those with Medicare fee-for-service between 2015 and 2019.”
  • Healthcare Dive reports,
    • “Healthcare employment growth fell across the board during the COVID-19 pandemic. Some sectors have had more difficulty rebounding than others, according to a new study — especially skilled nursing facilities, which face a controversial federal push for more staffing.
    • “Employment in hospitals increased 0.4% per quarter before the pandemic, but that growth rate shrunk to 0.03% during COVID-19, according to the study published in JAMA. By comparison, employment at skilled nursing facilities was already declining before COVID, dropping at a rate of 0.2% per quarter. During the pandemic, the rate of job losses accelerated to 1.1%.
    • “The Biden administration is seeking to impose mandatory nursing staffing minimums at skilled nursing facilities, or SNFs. The nursing home industry largely opposes the rule, arguing there are not enough workers available to meet the staffing mandate.” 

From the public health and research front,

  • The FEHBlog took the RSV vaccine today. The pharmacist who administered the injection told him the RSV vaccine are expected to be a once-every-decade experience for adults like the Tdap vaccine.
  • American Hospital News informs us,
    • “The more than 11,000 patients who received care during the first 16 months of the Acute Hospital Care at Home initiative had a low mortality rate and minimal complications related to escalations back to the brick-and-mortar hospital, according to a study reported Friday in JAMA Health Forum. CMS launched the initiative in November 2021 to address the COVID-19 public health emergency and concerns about hospital bed capacity. The Consolidated Appropriations Act of 2023 extended the CMS initiative through December 2024.
    • “The law also requires hospitals to provide additional data to CMS to monitor the quality of care, and for CMS to undertake a comprehensive study of the AHCAH initiative by September 30, 2024,” the authors note. “This study, data review, and additional monitoring will be important for identifying best practices that support safe and effective inpatient-level care delivered in the home environment.”
  • Per Fierce Healthcare,
    • “U.S. hospitals made gains to reduce healthcare-acquired infections (HAIs) but saw patient experiences further deteriorate in the latest release of an independent watchdog’s twice-yearly safety report.
    • “According to The Leapfrog Group, the sector has significantly reduced the incidences of Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) after reaching five-year highs during the COVID-19 pandemic.
    • “Specifically, 66% of the almost 3,000 general hospitals polled by the group improved their performance on at least one of the three HAIs. Nineteen percent improved across all three of the infection measures, while 16% either worsened or made no improvement.
    • “Now that we have pre- and post-pandemic data for patient safety measures, we are encouraged by the improvement in infections and applaud hospitals for reversing the disturbing infection spike we saw during the pandemic,” Leah Binder, president and CEO of The Leapfrog Group, said in a release.”
  • Here is a link to the Leapfrog Group report.
  • Beckers Hospital Review adds, “A comparison of data from CMS and The Leapfrog Group suggests that a hospital’s strong performance in one national quality rating system does not necessarily mean it will be a top performer in another.”
  • The New York Times Magazine gives us a story about the use of bariatric surgery on teenagers.

From the U.S. healthcare business front,

  • Reuters reports,
    • “Cigna is working with an investment bank to evaluate options for its Medicare Advantage business, which could fetch several billions of dollars in a potential divestment, the sources said.
    • “The discussions with interested parties, including other companies and private equity firms, are at an early stage, and Cigna may decide to keep the business, the sources added, requesting anonymity because the matter is confidential.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente reported $156 million in operating income (0.6% margin) for the third quarter, up from a $75 million operating loss (-0.3% margin) in the third quarter of 2022. 
    • “For the three months ended Sept. 30, Kaiser’s health plan, hospitals and their respective subsidiaries posted $24.9 billion in revenue and $24.7 billion in expenses, compared to $24.3 billion and $24.3 billion, respectively, in the same period of the prior year. 
    • “Net income for the third quarter was $239 million, up from a net loss of $1.5 billion in the third quarter of 2022.”
  • and
    • “As operating margins inch upward, hospitals are trending to profitability. But their performance still isn’t at pre-pandemic levels. 
    • “For the first three quarters of 2023, hospital operating margins were up 19% and operating EBIDA was up 11% compared to the same period last year, according to Kaufman Hall’s October National Hospital Flash Report. Net operating revenue per calendar day saw a 6% increase and even inpatient revenue was up 3%. Compared to 2020, year-to-date operating margins in September were down 2% and operating EBIDA margins were down 9%.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Tomorrow afternoon, the House Rules Committee will take up HR 4664, the financial services and general government appropriations bill that includes OPM and FEHB funding. The bill includes the typical FEHB appropriations provisions — the abortion coverage restriction, the contraceptives coverage mandate, and the prohibition against applying full Cost Accounting Standards coverage to experience-rated FEHB plan carriers.
  • The Federal Benefits Open Season begins next Monday, November 13, and ends on Monday, December 11, 2023. OPM has refreshed the Open Season website with 2024 plan information.

From the public health and research front,

  • NPR Shots discusses the impact of chronic drug shortages on hospitals and patients.
  • The Washington Post reports that “the hunt quickens” for vaccines and antibody therapies against opioids. For example,
    • “The federal government recently awarded an additional $14.8 million for research into a monoclonal antibody that would target fentanyl — the nation’s deadliest street drug — by binding to its molecules before they can invade the brain and shut down breathing. Cessation Therapeutics, a North Carolina biotech company, touts its monoclonal antibody as a way both to prevent overdoses and to treat overdoses and opioid addiction.”
  • Fortune Well tells us,
    • “Whether you snag some vitamin C at the first sign of a cold or stock up on probiotics to keep your gut health in check, you’re not alone in turning to dietary supplements—an estimated 75% of Americans use them.
    • “Among the various types, vitamin K is gaining popularity due to its potential benefits for healthy aging. Specifically, it is thought to aid in the prevention of age-related conditions such as osteoporosis and cardiovascular disease.”
  • Medscape informs us,
    • “Prescriptions for semaglutide jumped 150% in the past year, with an 80% increase in prescriptions written per provider, new data suggest.
    • “Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.”
  • and
    • “With nutrient-stimulated hormone therapies for obesity in phase 3 trials and activin-receptor inhibitors in the next upcoming drug class, highly effective treatments for obesity are on the horizon.
    • “We are at a watershed [moment] brought on by the recent introduction of highly effective antiobesity medications,” said Ania M. Jastreboff, MD, PhD, in a lecture at ObesityWeek.
    • “Jastreboff, from Yale University and the Yale Center for Weight Management, New Haven, Connecticut, provided an overview of the many nutrient-stimulated hormone-based antiobesity therapies in late phases of development — including dual and triple therapies with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon, and amylin.”
  • and
    • “New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.”
  • and, last but not least,
    • “T3D-959, an oral dual delta/gamma peroxisome proliferator-activated nuclear receptor (PPAR) agonist, has shown promise in a phase 2 randomized, placebo-controlled study of adults with mild-to-moderate Alzheimer’s disease (AD).”