Friday Factoids

NIH

Friday Factoids

David Ermer–FDA, HSA, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement. 
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News. 
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • “Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.

Midweek update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “Congress appears poised to leave town before Christmas without a topline spending agreement, which could doom the chances of getting full-fledged fiscal 2024 appropriations bills done in January.
    • “If there’s no deal on spending limits this week, lawmakers will essentially be out of time to work out the details of the 12 annual appropriations bills by Jan. 19, the first of two deadlines set in the last continuing resolution. The next deadline is Feb. 2, leaving little time to complete the last, larger batch of bills, particularly with the House scheduled to be in recess the week of Jan. 22.
    • “House Republicans remain far apart from both parties in the Senate and House Democrats on the total allocations appropriators have to parcel out to the dozen subcommittees so they can wrap up their bills.”
  • Health Affairs Forefront informs us,
    • Today, Micah Hartman and colleagues at the Centers for Medicare and Medicaid Services (CMS), including the National Health Expenditure Accounts Team, released their 2022 healthcare spending report.
    • The team finds that healthcare spending in the US grew 4.1 percent from 2021, reaching $4.5 trillion in 2022, which is a faster rate of growth than in 2021 but slower than in 2020.
    • They determine that the rate of growth has become more consistent with the prepandemic average annual growth rate of 4.4 percent.
    • Among other findings, they determine that the health share of GDP returned to a nearly prepandemic level in 2022, although this result was partly influenced by economywide inflation. 
    • In 2022, the insured share of the population reached 92.0 percent (a historic high), as private health insurance and Medicaid enrollment continued to experience strong growth.
  • Here’s a link to the CMS Fact Sheet on this report.
  • “The U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This follows the release of the HTI-1 proposed rule in April 2023. The HTI-1 final rule advances patient access, interoperability, and standards.”
    • Here’s a link to the Fierce Healthcare article on this action.
  • Health Affairs Forefront offers an article by two top government experts on what’s next with TEFCA.

From the U.S. public health and medical research front,

  • Beckers Hospital Review points out,
    • “JN.1 is now the fastest-growing COVID-19 variant in the U.S., accounting for around 21% of cases, data from the CDC shows.
    • “The strain is closely related to BA.2.86, which first caught experts’ attention over the summer because of its large number of mutations in the spike protein. JN.1 has a single additional change in its spike protein, the L455S mutation, which experts say has some immune-evasion properties worth keeping an eye on.
    • “The continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems,” the CDC said in a recent update about the variant. “At this time, there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants.” 
  • The New York Times reports,
    • “The nausea and vomiting that often define the first trimester of pregnancy are primarily caused by a single hormone, according to a study published on Wednesday in the journal Nature. Researchers said that the discovery could lead to better treatments for morning sickness, including rare, life-threatening cases of it.
    • “The study confirms prior research that had pointed to the hormone, called GDF15. The researchers found that the amount of hormone circulating in a woman’s blood during pregnancy — as well as her exposure to it before pregnancy — drives the severity of her symptoms.”
  • The New York Times also offers an expert opinion on how to close the large addiction treatment gap.
    • “The single most important thing lawmakers and health officials could do to usher in such changes is to improve their oversight of the addiction treatment industry. Too many states have not updated their regulations for addiction treatment facilities since the 1960s or ’70s. Many rely instead on independent accrediting agencies to separate good programs from bad ones. That approach frequently fails, as secret shopper studies and innumerable investigative reports have shown. “Accrediting organizations should feel humiliated by what we’ve seen from facilities that have their stamp of approval,” said Keith Humphreys. “But their incentive is to accredit everyone, because that’s how they get paid.”
  • Medscape notes,
    • “New recommendations to screen for heart failure, peripheral arterial disease (PAD), and type 1 diabetes risk, along with new obesity management guidance, are among many updates to the American Diabetes Association’s (ADA’s) Standards of Care for 2024.
    • “The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.”
  • Per MedPage Today,
    • “A high-dose recombinant influenza vaccine (Flublok Quadrivalent) was more protective than an egg-based standard-dose influenza vaccine in adults, according to results of a cluster-randomized, observational study.
    • Among adults ages 50 to 64, the high-dose vaccine was 15.3% more effective in preventing influenza than the standard-dose vaccine (95% CI 5.9-23.8, P=0.002) and 15.7% more effective against influenza A (95% CI 6.0-24.5, P=0.002), reported Nicola Klein, MD, PhD, from the Kaiser Permanente Vaccine Study Center in Oakland, California, and colleagues in the New England Journal of Medicine.
    • “Although the relative benefit of the high-dose vaccine appears to be modest, “reducing breakthrough influenza cases by 15% would provide a substantial public health benefit, especially during more severe influenza seasons,” Klein told MedPage Today in an email.”
  • and
    • Moderna’s mRNA-based RSV vaccine was effective at preventing RSV-associated lower respiratory tract disease in adults ages 60 and older, according to results of the randomized ConquerRSV trial.
    • The mRNA-1345 vaccine was 83.7% effective (95.88% CI 66%-92.2%) in preventing RSV-associated lower respiratory tract disease with at least two signs or symptoms, and similarly effective (82.4%) against lower respiratory tract disease with at least three signs or symptoms (96.36% CI 34.8%-95.3%), Eleanor Wilson, MD, of Moderna in Cambridge, Massachusetts, and colleagues reported in the New England Journal of Medicine. * * *
    • “An important consideration will be how much protection an mRNA vaccine provides during subsequent RSV seasons and whether subsequent boosting will be appropriate,” Angela Cohn, MD, and Aron Hall, DVM, MSPH, from the National Center for Immunization and Respiratory Diseases at the CDC in Atlanta, wrote in an accompanying editorial. “Such questions about duration of immunity, along with reactogenicity and cold-chain considerations, remain important areas for further evaluation in the implementation of mRNA vaccines.”
  • The National Institute on Drug Abuse announced,
    • The percentage of adolescents reporting they used any illicit substances in 2023 continued to hold steady below the pre-pandemic levels reported in 2020, with 10.9% of eighth graders, 19.8% of 10th graders, and 31.2% of 12th graders reporting any illicit drug use in the past year, according to the latest results from the Monitoring the Future survey. Reported use for almost all substances decreased dramatically between 2020 and 2021, after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, most reported substance use among adolescents held steady at these lowered levels, and these latest data show that this trend has continued into 2023.

From the U.S. healthcare business front,

  • We have another report on healthcare spending trends.
    • “Greater use of diagnostic testing and advances in medical technology and treatments are among the factors pushing medical trends higher than the rate of inflation, according the 45th National Healthcare Trend Survey, published by Buck, a Gallagher company, an integrated HR, pensions, and benefits consulting, technology, and administration services firm. The company has been monitoring medical trend factors used by health insurers and third-party administrations to project employers’ future healthcare costs since 1999.
    • “The survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants predicts even higher medical trend factors in the future due to providers renegotiating higher fees with insurers, as well as other changes occurring in the healthcare industry. Compared to the prior survey released in May 2023, the latest trends are up 50 to 100 basis points.”
  • Reuters reports,
    • “More than a quarter of 152 employers surveyed by the Business Group on Health said they would use virtual providers to oversee obesity drug prescriptions next year.
    • “Boeing (BA.N), Hilton (HLT.N), and Fortune Brands (FBIN.N) are among companies that have signed up for or expanded deals with virtual healthcare providers, according to sources familiar with the matter.
    • “Truist analyst Jailendra Singh forecasts the market for virtual obesity drug management could reach $700 million in 2024 and grow to as much as $9 billion longer term, assuming providers charge around $30 per member, per month, and $50 for physician appointments.”
  • The Wall Street Journal reports,
    • “Pfizer PFE  shares tumbled to their lowest close in more than nine years, after the giant drugmaker overestimated Covid-19 vaccine use and the company was forced to warn about its prospects.
    • “Shares fell 6.7% on Wednesday because the company, which has lost $140 billion in market cap this year, said its revenue could fall next year and issued 2024 guidance below analyst expectations.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hugo Clément on Unsplash

From Washington, DC

  • STAT New reports,
    • “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.
  • American Hospital Association News tells us,
    • “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,

  • The Wall Street Journal reports,
    • “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.
  • Beckers Hospital Review informs us,
    • “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.”

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “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.”
  • BioPharma Dive points out,
    • “AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel Therapeutics, just days after agreeing to a similar sized acquisition of the cancer biotechnology company ImmunoGen.
    • “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.”
  • Per Fierce Healthcare,
    • “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.”
  • and
    • “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.”
  • Health Payer Intelligence lets us know,
    • “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.”

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.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek update

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Midweek Update

David Ermer–ACA, Congress, COVID treatment, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • “Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, NIH, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC, comes an outcome that the FEHBlog didn’t expect.

  • The Washington Post reports,
    • “Rep. Kevin McCarthy (R-Calif.), after being removed as House speaker Tuesday, told fellow Republican lawmakers that he won’t seek the position again. The vote to remove him was the first such action in congressional history. McCarthy’s ouster was sought by hard-right members of his own party. McCarthy was removed by a 216-210 vote, with eight Republicans joining all Democrats in favor of the removal. The move puts the House in uncharted territory as it searches for a leader.
    • “Following McCarthy’s ouster, Rep. Patrick T. McHenry (R-N.C.) was designated as speaker pro tempore. He presided over the chamber briefly before calling a recess to allow Republicans and Democrats to meet privately.
    • “The House will take no further votes this week. Republicans are expected to hold a speaker candidate forum Tuesday, according to sources familiar with the plans who spoke on the condition of anonymity to discuss private deliberations.
  • The Wall Street Journal informs us
    • “Americans will soon be able to choose a third option in the updated Covid-19 booster-shot campaign.
    • “The Food and Drug Administration on Tuesday authorized the use of Novavax‘s Covid-19 shot in people age 12 and older. The shot has been updated to target a strain of the coronavirus that was circulating earlier this year, which health authorities say could help protect people through the fall and winter.
    • “The Centers for Disease Control and Prevention’s recommendation last month that most people receive updated booster shots applies to all updated boosters cleared by the FDA, now including Novavax’s, a CDC spokesman said. 
    • The recommendation clears the way for the vaccine to become available in pharmacies and other vaccination sites.
    • “Novavax said it priced the updated vaccine at $130 a dose, but most people are expected to be able to get it with no out-of-pocket cost.
    • “The company said it has millions of doses that will start to become available in the coming days. The shots will be offered at more than 13,000 sites around the U.S., including retail pharmacies and physician offices.”

From the public health front,

  • On Saturday, the FEHBlog made an appointment with a local chain pharmacy to get the new Covid booster. Later that day, he received a message from the pharmacy canceling the appointment because the booster was no longer available. Medscape points out that the FEHBlog’s experience was not unusual. The following posts put the FEHBlog’s problem in perspective though. There is good news if you can get to the end of this section.
  • The Washington Post has bad news about American life expectancy.
    • “Sickness and death are scarring entire communities in much of the country. The geographical footprint of early death is vast: In a quarter of the nation’s counties, mostly in the South and Midwest, working-age people are dying at a higher rate than 40 years ago, The Post found. The trail of death is so prevalent that a person could go from Virginia to Louisiana, and then up to Kansas, by traveling entirely within counties where death rates are higher than they were when Jimmy Carter was president.”
    • The FEHBlog thinks you don’t need a moonshot to address this problem. Connect people with primary care physicians early in their adult lives.
  • AHRQ’s Medical Expenditure Panel Survey lets us know,
    • “In 2020, about 1 of every 12 adults aged 18 and older received any heart disease treatment. The percentage of adults who received any heart disease treatment was highest among those aged 65 and older, higher among non-Hispanic Whites than among other racial/ethnic groups, and also higher among those in poor/low-income families than those in middle- or high-income families.
    • “Annual healthcare expenditures for the treatment of heart disease for adults in the civilian noninstitutionalized population totaled $114.9 billion in 2020 (a mean of $5,540 per adult treated for heart disease).
    • “Inpatient hospital care accounted for the largest proportion of annual medical spending for heart disease.
    • “Medicare and private health insurance combined paid about four-fifths of the medical spending for heart disease.”
  • Per Fierce Healthcare,
    • “About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.”About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.
    • “These health trends are bad for women and also for their employers.
    • “Primary care provider Parsley Health commissioned a survey of 1,200 full-time employed, insured women ages 18 to 60 to uncover their top health concerns and care challenges. The biggest takeaway? For many women, their healthcare needs have been left behind by a system that has largely ignored the broad, intersecting and complex health needs women experience across their lifetimes, Robin Berzin, M.D., founder and CEO of Parsley Health, said during an exclusive interview to review the survey results.”
  • The National Institutes of Health Directors notes,
    • “Chronic pain is an often-debilitating health condition and serious public health concern, affecting more than 50 million Americans. The opioid and overdose crisis, which stems from inadequate pain treatment, continues to have a devastating impact on families and communities across the country. To combat both challenges, we urgently need new ways to treat acute and chronic pain effectively without the many downsides of opioids.
    • “While there are already multiple classes of non-opioid pain medications and other approaches to manage pain, unfortunately none have proved as effective as opioids when it comes to pain relief. So, I’m encouraged to see that an NIH-funded team now has preclinical evidence of a promising alternative target for pain-relieving medicines in the brain.
    • “Rather than activating opioid receptors, the new approach targets receptors for a nerve messenger known as acetylcholine in a portion of the brain involved in pain control. Based on findings from animal models, it appears that treatments targeting acetylcholine could offer pain relief even in people who have reduced responsiveness to opioids. Their findings suggest that the treatment approach has the potential to remain effective in combatting pain long-term and with limited risk for withdrawal symptoms or addiction. * * *
    • “Finding treatments to modify acetylcholine levels or target acetylcholine receptors may therefore offer a means to treat pain and prevent it from becoming chronic. Encouragingly, drugs acting on these receptors already have been tested for use in people for treating other health conditions. It will now be important to learn whether these existing therapeutics or others like them may act as highly effective, non-addictive painkillers, with important implications for alleviating chronic pain.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly is making a bet on radiopharmaceutical drugs for cancer, announcing Tuesday a deal to buy Point Biopharma and its pipeline of experimental therapies for approximately $1.4 billion.
    • “Per acquisition terms, Lilly will pay $12.50 per Point share, a premium of about 87% to what the biotechnology company’s stock closed at Monday. The companies expect their deal to close “near the end” of this year.
    • “Based in Lilly’s home base of Indianapolis, Point specializes in radiopharmaceuticals, which pair a radioisotope with a targeting compound that delivers radiation directly into tumor cells. Recent improvements in manufacturing and supplying the complex treatments have boosted investment in the field, drawing interest from large pharma companies like Lilly as well as new drug startups.”
  • Healthcare Dive informs us,
    • “Growing expenses outpaced operating revenue at Trinity Health during its 2023 fiscal year ended June 30. The hospital system reported operating revenue of $21.6 billion on total expenses of $21.9 billion.
    • “Acquisitions for the Livonia, Michigan-based healthcare system added both $1.6 billion in revenue and $1.7 billion in operational expenses, according to the results released on Friday. The revenue gains were partially offset by the divestiture of St. Francis Medical Center in December 2022.
    • “Labor expenses continue to plague the hospital operator, which called contract rates “unprecedented” last year. Labor costs rose approximately 7.7% this year to $12 billion compared with $11.1 billion in the year prior. Contract labor accounted for $933 million compared with $626 million in 2022.”

Thursday Miscellany and Friday Factoids

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog failed to hit publish last night, so Thursday Miscellany was not emailed Friday morning. To correct the problem, Friday Factoids will follow Thursday September 21’s post. Lo siento

From Washington, DC,

  • The Hill reports
    • “Faced with the House stalemate over a government stopgap funding bill, Senate Majority Leader Chuck Schumer (D-N.Y.) on Thursday set up a path for the Senate to move first on a bill to fund the government beyond Sept. 30.  
    • “Schumer filed cloture on a motion to proceed to H.R. 3935, the House-passed bill to reauthorize the Federal Aviation Administration (FAA), which could serve as a legislative vehicle to pass a continuing resolution to fund the government through the Senate.   * * *
    • “Senators will spend next week debating and voting on the legislation in hopes of sending it to the House by Wednesday or Thursday of next week.”  
  • Roll Call adds
    • “The [new] plan [from the House of Representatives] is to ready more of the chamber’s 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a firm negotiating position for talks with the bigger-spending Senate.”
  • Yesterday, the Affordable Care Act regulators extended the public comment deadline for the proposed mental health parity rule revisions from October 2 to October 17, 2023.
  • Today, the Centers for Medicare and Medicaid Services posted a new announcement on its No Surprises Act website:
    • “Effective September 21, 2023, the Departments have directed certified IDR entities to resume processing all single and bundled disputes already submitted to the IDR portal and assigned to a certified IDR entity.  The ability to initiate new disputes involving air ambulance items or services as well as batched disputes for air ambulance and non-air ambulance items and services is currently unavailable. IDR portal functionalities related to previously initiated batched disputes are also unavailable. Disputing parties should continue to engage in open negotiation according to the required timeframes.”
  • CMS also updated its website with No Surprises Act rules and fact sheets.
  • Also today, the U.S. Office of Personnel Management
    • “released the Federal Workforce Competency Initiative (FWCI) General Competencies and Competency Models for a broad set of occupational series. The FWCI is a governmentwide effort led by OPM that updates a selection of general competencies from OPM’s MOSAIC (Multipurpose Occupational Systems Analysis Inventory—Closed-Ended) studies.  
    • “The FWCI competencies provide a common language for 214 occupational series. OPM has published 80 occupation-specific competency models representing work governmentwide that may be used for selection, evaluation, and training activities. The FWCI is a resource for agencies to leverage in their skills-based hiring practices. 
    • “OPM will continue to support agencies and collect critical data that strengthens our workforce and enables us to deliver services for the American people,” said OPM Director Kiran Ahuja. “This update to the Federal Workforce Competency Initiative will help agencies hire the talent they need and expand opportunities for positions that do not require certain degrees.” 
  • The Equal Employment Opportunity Commission posted its new strategic enforcement plan for 2024 through 2028.

From the public health front,

  • The American Medical Association identifies eight things doctors wish their patients knew about the flu shot.
  • The Washington Post reports,
    • “Poor oral hygiene is associated with an increased risk for myriad health problems, including heart disease, diabetes, cancer, rheumatoid arthritis and early death. The state of our teeth and gums, though, may be vital for our well-being beyond the mouth and body.
    • “Emerging evidence suggests that what goes on in our mouth can affect what goes on in our brain — and may even potentially affect our risk for dementia.
    • “People should really be aware that oral health is really important,” said Anita Visser, professor in geriatric dentistry at the University of Groningen in the Netherlands.”
  • Per a CVS Health press release,
    • “A recent CVS Health®/Harris Poll survey of Americans 18 years and older found that nearly one in five (18%) U.S. adults say they were plagued with suicidal thoughts in the past year.  
    • “Other key findings from the survey include:
      • “More than a third of younger adults aged 18-34 (36%) say they had moments in the past year where they contemplated suicide.
      • “An overwhelming nine in ten (89%) U.S. adults deem suicide prevention efforts a major priority in our society.
      • “However, less than a third (32%) strongly agree they can recognize the warning signs of someone potentially at risk, and only four in ten (43%) are strongly aware of resources that offer support and information on suicide prevention.
      • “Nearly eight in ten (77%) U.S. adults believe healthcare providers have a crucial role in suicide prevention, and there is an opportunity for providers to have more discussions about suicide with patients.”

From the U.S. healthcare business front

  • Per Healthcare Dive,
    • “The Federal Trade Commission is suing anesthesia provider U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson and Stowe, alleging the two colluded to consolidate anesthesiology practices in Texas, driving up prices to boost their profits.
    • “Welsh Carson created USAP in 2012 before acquiring over a dozen anesthesia providers over the next decade to create a single dominant provider in the state, regulators allege. The PE firm and USAP also made price-setting agreements with independent anesthesiology practices while sidelining a potential competitor by striking a deal to keep them out of USAP’s market, the FTC said.
    • “The complaint filed Thursday in federal district court says the actions have cost Texans “tens of millions of dollars” more each year in anesthesiology services.”
  • MedCity News offers insights on value-based care from an executive at the HealthPartners HMO in Minnesota. “The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.”
  • Beckers Hospital Review tells us,
    • “Nearly 1,900 U.S. physicians have applied to become certified in obesity medicine — a record number — according to data from the American Board of Obesity Medicine. 
    • “In October, 1,889 physicians will take the exam to become certified in the specialty area. That’s up from 1,001 exam candidates in 2020, marking an 88.7 percent jump. Physicians’ growing interest in the certification comes amid booming patient demand for GLP-1 receptor agonist drugs such as Ozempic and Wegovy. As of August, 2023, sales for Ozempic in the U.S. topped $3 billion. 
    • “More than 6,700 physicians are certified in obesity medicine, a certification that first became available in 2012. For the upcoming exam in October, 38 percent of exam candidates are internal medicine physicians and 30 percent family medicine. To sit for the exam, physicians must have completed a minimum of 60 continuing medical education credits on the topic of obesity.” 
  • The FEHBlog notes that if you build it, they will come.
  • Fierce Healthcare looks inside Walgreens’ pharmacy and primary care model.
  • The Wall Street Journal reports,
    • “Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
    • “The Food and Drug Administration inspected the Clayton, N.C., plant in July and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.  
    • “The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
    • “The Danish company said the Clayton plant is still running and producing for the market and wouldn’t share details of its interactions with the FDA.
    • “The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.”

Friday, September 23, 2023 Post

From Washington DC,

  • Senator Chuck Grassley (R Iowa) announced
    • “A bipartisan bill led by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to improve access to lifesaving organ donations became law today. The Securing the U.S. Organ Procurement and Transplantation Network Act will improve the management of the U.S. organ donation system by breaking up the contract for the Organ Procurement and Transplantation Network (OPTN) and encouraging participation from competent and transparent contractors. U.S. Sens. Ben Cardin (D-Md.), Todd Young (R-Ind.) and Bill Cassidy (R-La.) are original cosponsors of the legislation.”
  • The Wall Street Journal reports,
    • “The collapse this week of efforts to pass spending bills through the House has ignited a long-shot push to head off a government shutdown, with a bipartisan group of senators floating legislation that provides carrots and sticks to force lawmakers to reach a deal.
    • “The lawmakers’ novel approach would aim to ensure Congress completes its work on all 12 appropriations bills needed to fund the government, without the threat of a shutdown that would furlough hundreds of thousands of federal workers and leave government contractors unpaid. Major government functions will stop on Oct. 1 at 12:01 a.m. unless Congress acts.
    • “The bill, co-sponsored by Sens. James Lankford (R., Okla.) and Maggie Hassan (D., N.H.), would set in motion 14-day continuing resolutions, which keep the government funded at the prior year’s levels, while Congress works exclusively on passing appropriations bills.” 
  • Bloomberg points out
    • “The threat of a massive tax is enough to push drugmakers such as Boehringer Ingelheim Pharmaceuticals, Inc. and Novartis AG to comply with the Biden administration’s landmark drug pricing law and negotiate with Medicare.
    • “Companies who manufacture the first 10 drugs selected to negotiate prices with Medicare have until Oct. 1 to officially agree to enter price talks. Under the Inflation Reduction Act, those who refuse to comply with the negotiations must pay a tax starting at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”
  • That’s a lot of leverage.
  • The Consumer Financial Protection Bureau has “announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.” In the FEHBlog’s view, this approach is bound to backfire as lenders lose faith in credit reports.

From the public health and medical research front,

  • MedPage Today informs us
    • “Nearly half of U.S. states had an adult obesity prevalence at or above 35% in 2022, according to CDC.
    • “The 22 states that met this mark — a small jump from the 19 states just the year prior — included Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.”
  • and
    • The CDC’s advisors on Friday recommended a maternal respiratory syncytial virus (RSV) vaccine to protect infants from serious infections.
    • By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks gestation to prevent lower respiratory tract RSV infection in infants.
    • After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
  • STAT News adds, “The recommendation was accepted by CDC Director Mandy Cohen shortly after the conclusion of the panel’s meeting.”
  • Per BioPharma Dive,
    • “A new cancer drug developed by Daiichi Sankyo and AstraZeneca met one of its two main goals in a breast cancer trial, helping patients who had progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, the companies said Friday.
    • “The trial tested the drug, known as datopotamab deruxtecan, in HER2-low or -negative patients whose tumors were sensitive to hormone treatments before their cancer returned. AstraZeneca and Daiichi didn’t release detailed data and stated that the trial hadn’t gone on long enough to tell if patients given their treatment lived longer overall, the trial’s other main goal.
    • “The data suggest the companies’ drug could present a threat to Gilead’s similarly acting medicine Trodelvy, which gained approval in a similar setting earlier this year. HR-positive, HER2-negative breast cancer is the most common form of the disease.”
  • and
    • “A combination of cancer drugs from Seagen and Merck & Co. has shown early success in a large clinical trial, results that help confirm the pairing’s ability to treat a wide range of bladder cancer patients.”
  • The National Institutes of Health announced
    • “A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world. It is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS).
    • “Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized COVID-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.”
  • The Wall Street Journal poses ten questions about experimental drugs that can be made available to seriously ill patients.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Catholic healthcare giant CommonSpirit Health has reported a $1.4 billion operating loss (-4.1% operating margin) and a net loss of $259 million for its 2023 fiscal year, which ended June 30, according to financial statements released Thursday.
    • “The nonprofit, which currently operates 145 hospitals across 24 states, had logged a $1.3 billion operating loss (-3.8% operating margin) and a $1.8 billion deficit of revenues over expenses during its prior fiscal year.
    • “This time around, the organization enjoyed patient volumes that “reached pre-pandemic levels in many of the health system’s markets” but was dragged by “private and government reimbursements [that] did not keep pace with increased costs of providing care to patients,” CommonSpirit said in a release accompanying the latest financial filings. The most recent year’s operating performance also included a $160 million adverse impact from a fall 2022 cybersecurity breach that affected numerous locations.”
  • Healthcare Dive tells us,

    • The CMS is poised to crack down further on health insurers in the Medicare Advantage program, according to new comments from a top agency official.

    • MA plans — which now cover more than half of Medicare beneficiaries — have faced rising criticism over care denials and access, along with improper coding practices that inflate the program’s cost.

    • “You will see CMS in the future be a much tougher payer and much tougher regulator to ensure that, for every beneficiary and taxpayer who pay more for it, the value is there, the service is there and beneficiaries have full information for the choices that they’re making,” CMS Deputy Administrator Jon Blum said Thursday at the National Association of ACOs’ fall conference in Washington, D.C.